Fluoroscopic visualization of heart valve anatomy

Abstract

To provide an apparatus and system for use in visualization of the anatomy in the body of a patient such as in the heart of the patient.SOLUTION: For example, an annulus-marking device can include various visualization features and elements including a radiopaque material. Such visualization features and elements facilitate visualization of a heart valve anatomy, such as a heart valve annulus, leaflet and / or other part. Various visualization devices can be used for identifying a site or region for anchoring an implant to the heart valve anatomy.SELECTED DRAWING: Figure 8A

Description

[Technical field]

[0001] [CROSS REFERENCE TO RELATED APPLICATIONS] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 988,322, entitled "FLUOROSCOPIC VISUALIZATION OF HEART VALVE ANATOMY," filed March 11, 2020, and U.S. Provisional Patent Application No. 62 / 877,785, entitled "FLUOROSCOPIC VISUALIZATION OF HEART VALVE ANATOMY," filed July 23, 2019, the disclosures of which are incorporated herein by reference in their entirety for all purposes. [Background technology]

[0002] Implantation of medical devices can be fluoroscopically assisted, for example in catheter-based procedures including heart valve repair and replacement. Ideally, patient exposure to fluoroscopy is kept to a minimum. Summary of the Invention [Means for solving the problem]

[0003] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples of this summary are not required by the claims unless the claims explicitly recite those features. Also, the described features can be combined in various ways. Various features and steps described elsewhere in this disclosure can also be included in the examples summarized here.

[0004] In some applications, systems and methods are provided to assist in the implantation of cardiac devices under fluoroscopic guidance using radiopaque devices that act as guides to facilitate enhanced imaging of the cardiac space during implantation of the cardiac implant, thereby minimizing patient exposure to fluoroscopy over a given period of time.

[0005] Thus, according to some applications, a system and / or apparatus is provided for use with a subject, the system / apparatus including a visualization device or anatomy marking device (e.g., annulus marking device, etc.) including a radiopaque material and an implant for implantation along a native heart annulus of the subject. In some implementations, the visualization device, anatomy marking device, or annulus marking device is configured to provide a guide for implanting the implant along the annulus during implantation and is retrievable following implantation of the implant.

[0006] Throughout this application, the term annulus marking device is often used for illustrative purposes, however, the terms anatomical structure marking device, heart valve marking device, and visualization device may be substituted for the term "annulus marking device," and in any event, these devices may be used to mark or visualize other areas within the patient's heart and / or other organs.

[0007] In some applications, the annulus marking device and / or radiopaque material is configured and shaped to define a foundation frame having a shape that follows the circumference of the native heart valve annulus and / or one or more struts that project away from a plane defined by the foundation frame. The one or more struts can be configured to provide indication of one or more commissures of the native heart valve.

[0008] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning along the native heart valve annulus.

[0009] In one application, the annulus marking device includes a superelastic material.In one application, the foundation frame and the one or more struts are fabricated from a single piece.

[0010] In one application, the one or more struts are sized to provide an indication as to the height of the native heart valve annulus.

[0011] In one application, the foundation frame is circular. In one application, the foundation frame is substantially D-shaped.

[0012] In one application, the foundation frame includes wire.

[0013] In one application, the foundation frame includes an adjustment mechanism for expanding and contracting the perimeter of the foundation frame.

[0014] In one application, the adjustment mechanism includes a wire that passes at least partially through a lumen of the foundation frame, the wire being capable of being pulled to adjust the circumference of the foundation frame.

[0015] In one application, the adjustment mechanism includes a wire that passes at least partially through a lumen of the foundation frame, the wire being capable of being twisted to adjust the circumference of the foundation frame.

[0016] In one application, the adjustment mechanism includes a wire that passes at least partially through a lumen of the foundation frame, and at least a portion of the foundation frame telescopically collapses in response to the wire being pulled.

[0017] In one application, the annulus marking device includes a plurality of radiopaque filaments at least coupled to a base frame, each of the plurality of filaments protruding radially away from the base frame and configured to mark the native heart valve annulus and tissue coupled thereto.

[0018] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0019] According to some applications, there is further provided a method including placing an annulus marking device including a radiopaque material at a native heart annulus of a subject, and implanting an implant along the native heart annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may further include retrieving the annulus marking device after implantation.

[0020] The annulus marking device and / or radiopaque material can be the same as or similar to any of the annulus marking devices and / or radiopaque materials described herein. In some implementations, the annulus marking device and / or radiopaque material is shaped to define a foundation frame having a shape that follows the circumference of the native heart valve annulus and / or one or more struts that project away from a plane defined by the foundation frame, the one or more struts providing an indication of one or more commissures of the native heart valve.

[0021] The annulus marking device may be compressible during delivery to the native heart valve and may be expandable from a compressed state for positioning along the native heart valve annulus.

[0022] In one application, placing the annulus marking device includes measuring annulus height using the annulus marking device.

[0023] In one application, the method further includes adjusting a perimeter of the foundation frame.

[0024] In one application, implanting under imaging includes implanting using fluoroscopy.

[0025] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0026] In one application, the placing includes placing an annulus marking device along the annulus of the mitral valve.

[0027] In one application, the placing includes placing an annulus marking device along an annulus of a tricuspid valve.

[0028] In one application, the annulus marking device includes a plurality of radiopaque filaments at least coupled to the base frame, each of the plurality of radiopaque filaments protruding radially away from the base frame, and the method further includes using the plurality of radiopaque filaments to view tissue of the native heart annulus and tissue coupled thereto.

[0029] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0030] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0031] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0032] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0033] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including an implant configured to be positioned along a native heart valve annulus, the implant including a body portion including a flexible material having a longitudinal axis extending along a length of the body portion (e.g., when the implant and / or body portion is straightened), and an annulus marking device, structure, or assembly including a plurality of radiopaque protrusions protruding away from the longitudinal axis.

[0034] The implant can further include a contraction member coupled to the body portion. The contraction member can be coupled to and / or extend along or through the plurality of radiopaque protrusions, such that during application of tension to the contraction member, the contraction member is configured to change a structural configuration of the plurality of radiopaque protrusions.

[0035] In one application, the contraction member is configured to radially compress the plurality of radiopaque protrusions toward the longitudinal axis of the body portion.

[0036] In one application, the contraction member is configured to contract the body portion during application of tension to the contraction member.

[0037] In one application, the device further includes an additional constriction member extending along the body portion, the additional constriction member configured to constrict the body portion.

[0038] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion.

[0039] In one application, the contraction member extends along a periphery of each of the plurality of radiopaque protrusions.

[0040] In one application, the plurality of radiopaque protrusions are flexible and comprise fabric.

[0041] In one application, the body portion and the plurality of radiopaque protrusions are flexible and comprise fabric.

[0042] In one application, each of the plurality of radiopaque protrusions is shaped to define a respective flat planar element.

[0043] In one application, each flat planar element has a longest dimension measured along an axis that forms a non-zero angle with respect to the longitudinal axis of the body portion.

[0044] In one application, each of the plurality of radiopaque protrusions is shaped to define a plurality of tubular elements.

[0045] In one application, the constriction member extends along a periphery of each opening in each of the plurality of tubular elements.

[0046] In one application, each of the plurality of tubular elements tapers away from the longitudinal axis of the body portion.

[0047] According to some applications, there is further provided a method including placing an implant in a subject's native heart valve annulus, the implant comprising a body portion and an annulus marking device configured to be positioned along the native heart valve annulus; deploying, under imaging, a plurality of tissue anchors through the body portion of the implant and into tissue of the native heart valve annulus using the annulus marking device as a guide; and altering a structural configuration of the implant.

[0048] The implant can be the same as or similar to other implants described herein. For example, in some implementations, the implant includes a body portion including a flexible material having a longitudinal axis extending along the length of the body portion (e.g., when the implant and / or the body portion is straightened), and an annulus marking device including a plurality of radiopaque protrusions that protrude away from the longitudinal axis. The implant can include a contraction member coupled to the body portion. The contraction member can be coupled to the plurality of radiopaque protrusions and / or can extend along or through the plurality of radiopaque protrusions such that during application of tension to the contraction member, the contraction member is configured to change a structural configuration of the plurality of radiopaque protrusions.

[0049] For some applications, altering the structural configuration of the implant includes altering the structural configuration of the plurality of radiopaque protrusions by applying tension to a contraction member.

[0050] In one application, altering the structural configuration of the plurality of radiopaque protrusions includes radially compressing the plurality of radiopaque protrusions toward a longitudinal axis of the body portion.

[0051] In one application, applying tension to the contraction member includes adjusting the circumference of the implant by contracting a body portion using the contraction member.

[0052] In one application, the implant includes an additional contraction member extending along the body portion, and the method further includes adjusting a circumference of the implant by contracting the body portion using the additional contraction member.

[0053] In one application, the placing includes placing the implant along the annulus of the mitral valve.

[0054] In one application, the placing includes placing the implant along an annulus of a tricuspid valve.

[0055] In one application, varying the structural configuration of the plurality of radiopaque protrusions includes sequentially varying the structural configuration of the plurality of radiopaque protrusions.

[0056] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion, and deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors in accordance with the respective radiopaque markings.

[0057] In one application, the contraction member extends along a periphery of each of the plurality of radiopaque protrusions, and changing the structural configuration of the plurality of radiopaque protrusions includes compressing the plurality of radiopaque protrusions by contracting the contraction member along a periphery of each of the plurality of radiopaque protrusions, thereby drawing each of the plurality of radiopaque protrusions toward the longitudinal axis.

[0058] In one application, the plurality of radiopaque protrusions are flexible and comprise fabric.

[0059] In one application, each of the plurality of radiopaque protrusions is shaped to define a plurality of flat, planar elements, and altering the structural configuration of the plurality of radiopaque protrusions includes pulling each of the plurality of radiopaque protrusions toward the longitudinal axis by bending each of the plurality of flat, planar elements.

[0060] In one application, each of the plurality of radiopaque protrusions is shaped to define a plurality of tubular elements.

[0061] In one application, the contraction member extends along a periphery of each opening of each of the plurality of tubular elements, and changing the structural configuration of the plurality of radiopaque protrusions includes closing each opening of each of the plurality of tubular elements.

[0062] In one application, each of the plurality of tubular elements tapers away from the longitudinal axis of the body portion.

[0063] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith under imaging of the plurality of radiopaque protrusions.

[0064] In one application, viewing the tissue includes imaging using fluoroscopy.

[0065] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging a plurality of radiopaque protrusions relative to the tissue of the native heart valve annulus and associated tissue by viewing a plurality of radiopaque protrusions relative to the tissue.

[0066] In one application, viewing the tissue of the native heart valve annulus includes imaging the plurality of radiopaque protrusions relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of radiopaque protrusions in response to movement of the tissue.

[0067] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0068] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0069] According to some applications, there is further provided a system and / or apparatus including a tissue anchor including a distal tissue coupling element, the distal tissue coupling element having a longitudinal axis measured from a distal end to a proximal end of the distal tissue coupling element, the tissue anchor being configured to be anchored and / or secured to tissue of a native heart valve annulus, and an annulus marking device coupled to the tissue anchor. In some implementations, the annulus marking device includes a radiopaque material and / or is configured to protrude away from the longitudinal axis of the distal tissue coupling element.

[0070] In one application, the distal tissue coupling element is hollow and the annulus marking device extends through the lumen of the distal tissue coupling element.

[0071] In one application, the tissue anchor includes a proximal head coupled to a proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

[0072] In one application, the device further includes an annuloplasty structure including a tubular body portion, the proximal head configured to be disposed within the tubular body portion, and the distal tissue coupling element configured to be anchored within tissue of the native heart valve annulus.

[0073] In one application, the annulus marking device is coupled to a distal tissue coupling element.

[0074] In one application, the annulus marking device is coupled to a distal end of the distal tissue coupling element.

[0075] In one application, the apparatus further includes an annuloplasty structure including a fabric, and the annulus marking device is configured to pass through the fabric of the annuloplasty structure.

[0076] In one application, the annulus marking device includes one or more radiopaque filaments configured to mark the native heart annulus and tissue associated therewith.

[0077] In one application, each of the one or more radiopaque filaments includes a flexible material.

[0078] According to some applications, a method is further provided that includes marking a location of a target native heart valve annulus by implanting within tissue of the native heart valve annulus a tissue anchor including a distal tissue coupling element, the distal tissue coupling element having a longitudinal axis measured from a distal end to a proximal end of the distal tissue coupling element and configured to be anchored within tissue of the native heart valve annulus.

[0079] The annulus marking device can be coupled to the tissue anchor, the annulus marking device including a radiopaque material, and can be configured to protrude away from the longitudinal axis of the distal tissue coupling element.

[0080] The method further includes imaging the location and viewing the annulus marking device against tissue of the native heart annulus during imaging.

[0081] In one application, imaging the tissue includes imaging using fluoroscopy.

[0082] In one application, marking the location includes marking the location along an annulus of a mitral valve.

[0083] In one application, marking the location includes marking the location along an annulus of a tricuspid valve.

[0084] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

[0085] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0086] In one application, viewing the tissue of the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0087] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0088] In one application, the tissue anchor includes a proximal head coupled to a proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

[0089] In one application, the method further includes implanting an annuloplasty structure including a tubular body portion along the native heart valve annulus, and implanting the tissue anchor includes implanting the distal tissue coupling element into tissue of the native heart valve annulus while positioning the proximal head within the tubular body portion.

[0090] In one application, the annulus marking device is coupled to a distal tissue coupling element.

[0091] In one application, the annulus marking device is coupled to a distal end of the distal tissue coupling element.

[0092] In one application, the method further includes implanting an annuloplasty structure including a fabric along the native heart annulus, and implanting the tissue anchor includes passing an annulus marking device through the fabric of the annuloplasty structure.

[0093] In one application, passing the annulus marking device through the fabric of the annuloplasty structure includes passing the annulus marking device through the fabric of the portion of the annuloplasty structure before the portion of the annuloplasty structure is positioned along the native heart annulus, and the method further includes imaging the native heart annulus before the portion of the annuloplasty structure is positioned along the native heart annulus.

[0094] In one application, the annulus marking device includes one or more radiopaque filaments configured to mark the native heart annulus and tissue associated therewith.

[0095] In one application, each of the one or more radiopaque filaments includes a flexible material.

[0096] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0097] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including an implant configured to be positioned along a native heart valve annulus. The implant can include a body portion including a flexible material, the body portion having a longitudinal axis extending along a length of the body portion (e.g., when the implant and / or the body portion is straightened). The implant can also include an annulus marking device including one or more planar radiopaque fins extending along at least a portion of the body portion and projecting away from the longitudinal axis, each of the one or more planar radiopaque fins having a longest dimension measured along the longitudinal axis.

[0098] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion.

[0099] In one application, the one or more planar radiopaque fins include a flexible fabric.

[0100] In one application, the one or more planar radiopaque fins include two or more planar radiopaque fins.

[0101] In one application, the device further includes at least one tissue anchor deployable through the body portion of the implant and between the two or more planar radiopaque fins.

[0102] According to some applications, there is further provided a method including placing an implant at a subject's native heart annulus, the implant including a body portion including a flexible material configured to be positioned along the native heart annulus and an annulus marking device, the method further including deploying, under imaging, at least one tissue anchor through the body portion of the implant and into tissue of the native heart annulus using the annulus marking device as a guide.

[0103] In some implementations, the body portion has a longitudinal axis extending along a length of the body portion (e.g., when the implant and / or the body portion is straightened), and the annulus marking device includes one or more planar radiopaque fins extending along at least a portion of the body portion and projecting away from the longitudinal axis. In some implementations, each of the one or more planar radiopaque fins has a longest dimension measured along the longitudinal axis.

[0104] In one application, deploying under imaging includes imaging using fluoroscopy.

[0105] In one application, the placing includes placing the implant along the annulus of the mitral valve.

[0106] In one application, the placing includes placing the implant along an annulus of a tricuspid valve.

[0107] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion, and deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors in accordance with the respective radiopaque markings.

[0108] In one application, the one or more planar radiopaque fins are flexible and comprise fabric.

[0109] In one application, the one or more planar radiopaque fins include two or more planar radiopaque fins.

[0110] In one application, deploying at least one tissue anchor through the body portion of the implant includes deploying at least one tissue anchor through the body portion of the implant and between two or more planar radiopaque fins.

[0111] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of one or more planar radiopaque fins.

[0112] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and associated tissue by viewing one or more planar radiopaque fins relative to the tissue.

[0113] In one application, viewing the tissue of the native heart valve annulus includes imaging one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the one or more planar radiopaque fins in response to movement of the tissue.

[0114] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0115] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including an implant configured to be positioned along a native heart valve annulus of the subject, the implant including a body portion including a flexible material. The system / apparatus also includes an annulus marking device.

[0116] The annulus marking device can be the same as or similar to other annulus marking devices described herein. For example, in some implementations, the annulus marking device includes a scaffold including a radiopaque material. The scaffold can be collapsible and expandable and can be configured to extend along at least one side of a body portion of the implant when expanded. In some implementations, a plurality of radiopaque filaments are coupled to the scaffold at least at a distal end of the scaffold, the plurality of filaments being configured to mark the native heart annulus and / or tissue coupled thereto.

[0117] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion.

[0118] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0119] In one application, the scaffold includes a plurality of struts collectively arranged in a triangular shape, the scaffold being generally planar and extending along a sidewall of the body portion when the scaffold is expanded.

[0120] In one application, the annulus marking device is coupled to a delivery tool configured to deliver the implant to the native heart annulus, and the annulus marking device is retrievable upon removal of the delivery tool from the subject.

[0121] In one application, the delivery tool is configured to surround a portion of the body portion of the implant, and the annulus marking device is configured to at least partially surround the body portion of the implant.

[0122] In one application, the delivery tool includes fins coupled to a distal portion of the delivery tool and a portion of the scaffold, such that movement of the fins in response to blood flow orients the scaffold relative to a body portion of the implant by rotation.

[0123] In one application, the scaffold is coupled to a ring at a proximal end of the scaffold, the ring surrounding at least a portion of the body portion of the implant and movable proximally and distally relative to the body portion of the implant, such that the scaffold is movable to multiple locations along the body portion of the implant.

[0124] In one application, the scaffold is shaped to partially surround a given portion of a body portion of the implant, and the plurality of radiopaque filaments includes a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length, and the first and second subsets are configured to rotate to orient the scaffold relative to the implant.

[0125] In one application, the scaffold is semi-tubular. In one application, the scaffold is planar and generally triangular. In one application, the scaffold is frusto-conical, although other shapes are possible.

[0126] In one application, the scaffold is shaped to partially surround a given portion of a body portion of the implant, and the plurality of radiopaque filaments includes a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness, and the first and second subsets are configured to rotate to orient the scaffold relative to the implant.

[0127] In one application, the scaffold is semi-tubular. In one application, the scaffold is planar and generally triangular. In one application, the scaffold is frusto-conical, although other shapes are possible.

[0128] In one application, the scaffold includes a plurality of struts collectively arranged in a frusto-conical shape, the scaffold surrounding at least a portion of the body portion of the implant.

[0129] In one application, the scaffold is movable proximally and distally relative to the body portion of the implant such that the scaffold is movable to multiple locations along the body portion of the implant.

[0130] According to some applications, there is further provided a method that includes placing an implant including a body portion including a flexible material in a native heart valve annulus of a subject, and viewing the placement under imaging by imaging the annulus marking device.

[0131] In some applications, the annulus marking device comprises a scaffold including a radiopaque material, the scaffold being foldable and expandable and configured to extend along at least one side of a body portion of the implant when expanded. In some implementations, a plurality of radiopaque filaments are coupled to the scaffold at least at a distal end of the scaffold, the plurality of filaments being configured to mark the native heart valve annulus and tissue coupled thereto.

[0132] In one application, viewing the placement further includes imaging a plurality of radiopaque markings on the body portion of the implant and deploying an anchor along the body portion in response to imaging the plurality of radiopaque markings on the body portion of the implant.

[0133] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0134] In one application example, the scaffold includes a plurality of struts collectively arranged in a triangular shape, the scaffold being generally planar and extending along a sidewall of the body portion when the scaffold is expanded, and imaging the annulus marking device includes imaging the triangular shape of the scaffold relative to the tissue and the body portion of the implant.

[0135] In one application, placing the implant includes delivering the implant using a delivery tool coupled to an annulus marking device, and the method further includes retrieving the annulus marking device during removal of the delivery tool from the subject.

[0136] In one application, the delivery tool is configured to surround a portion of the body portion of the implant, and the annulus marking device is configured to at least partially surround the body portion of the implant.

[0137] In one application, the delivery tool includes a fin coupled to a distal portion of the delivery tool and a portion of the scaffold, and the method further includes orienting the scaffold relative to a body portion of the implant by rotation in response to movement of the fin in response to blood flow.

[0138] In one application, the scaffold is coupled to a ring at a proximal end of the scaffold, the ring surrounding at least a portion of the body portion of the implant and movable proximally and distally relative to the body portion of the implant, and the method further includes facilitating movement of the scaffold to a plurality of locations along the body portion of the implant.

[0139] In one application, the scaffold is shaped to partially surround a given portion of a body portion of the implant, and the plurality of radiopaque filaments includes a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length, and the method further includes orienting the scaffold relative to the implant by rotation using the first and second subsets.

[0140] In one application, the scaffold is semi-tubular. In one application, the scaffold is planar and generally triangular. In one application, the scaffold is frusto-conical. Other shapes are possible.

[0141] In one application, the scaffold is shaped to partially surround a given portion of a body portion of the implant, and the plurality of radiopaque filaments includes a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness, and the method further includes orienting the scaffold relative to the implant by rotation using the first and second subsets.

[0142] In one application, the scaffold is semi-tubular. In one application, the scaffold is planar and generally triangular. In one application, the scaffold is frusto-conical. Other shapes are possible.

[0143] In one application, the scaffold includes a plurality of struts collectively arranged in a frusto-conical shape, the scaffold surrounding at least a portion of the body portion of the implant.

[0144] In one application, the scaffold is movable proximally and distally relative to the body portion of the implant, and the method further includes facilitating movement of the scaffold to multiple locations along the body portion of the implant.

[0145] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0146] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including an annulus marking device including a radiopaque material and an implant for implantation along the annulus of a valve of the subject.

[0147] The annulus marking device and / or radiopaque material can be the same as or similar to other annulus marking devices and / or radiopaque materials described elsewhere herein. For example, in some implementations, the annulus marking device and / or radiopaque material is shaped to define a tubular stent body having a central longitudinal axis and configured to be positioned within a subject native heart valve, and / or a plurality of extensions coupled to a proximal end of the tubular stent body and projecting away from the longitudinal axis of the stent body, the plurality of extensions configured to be positioned circumferentially around an annulus of the native heart valve.

[0148] The annulus marking device may be compressible during delivery to the native heart valve and may be expandable from a compressed state for positioning within the native heart valve.

[0149] In one application, the annulus marking device is configured to provide a guide for placing an implant along the annulus during implantation and is retrievable after implantation of the implant.

[0150] In one application, the annulus marking device includes a superelastic material.

[0151] In one application, the stent body and extensions are fabricated from a single piece.

[0152] In one application, the tubular stent body includes two or more prosthetic leaflets.

[0153] In one application, the device further includes a plurality of anchors, each of the plurality of anchors configured to anchor the implant to an annulus of the native valve, and each of the anchors configured to be implanted between adjacent extensions of the plurality of extensions.

[0154] According to some applications, there is further provided a method including placing an annulus marking device including a radiopaque material in a subject's native heart valve, the annulus marking device shaped to define: (1) a tubular stent body having a central longitudinal axis and configured to be placed in the subject's native heart valve; and (2) a plurality of extensions coupled to a proximal end of the tubular stent body and projecting away from the longitudinal axis of the stent body, the plurality of extensions configured to be placed along a circumference of the annulus of the native heart valve. The method further includes implanting an implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may include retrieving the annulus marking device after implantation.

[0155] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning within the native heart valve.

[0156] In one application, implanting under imaging includes implanting using fluoroscopy.

[0157] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0158] In one application, the placing includes placing the annulus marking device in a mitral valve.In one application, the placing includes placing the annulus marking device in a tricuspid valve.

[0159] In one application, implanting the implant includes anchoring the implant to the annulus of the native valve by deploying each anchor of the plurality of anchors between adjacent extensions of the plurality of extensions.

[0160] In one application, retrieving the annulus marking device after implantation includes sliding a plurality of extensions from underneath the implant.

[0161] In one application, the method further includes using the multiple extensions to view tissue of the native heart valve annulus and tissue associated therewith.

[0162] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of extensions relative to the tissue.

[0163] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of extensions in response to movement of the tissue.

[0164] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0165] According to some applications, there is further provided a method including positioning an annulus marking device including a mapping catheter at a subject's native heart valve annulus, generating a map of the native heart valve annulus under imaging using the mapping catheter, and implanting an implant in the native heart valve annulus under imaging in response to generating the map.

[0166] In one application, implanting under imaging includes implanting using fluoroscopy.

[0167] In one application, the method further includes retrieving the annulus marking device after generating the map and then extracting the annulus marking device from the subject.

[0168] In one application, the placing includes placing the annulus marking device along the annulus of a mitral valve.In one application, the placing includes placing the annulus marking device along the annulus of a tricuspid valve.

[0169] In one application, the mapping catheter includes a radiopaque material, and generating the map includes imaging the mapping catheter under fluoroscopy.

[0170] In one application, the mapping catheter includes a magnetic subunit, and generating the map includes generating a magnetic field and mapping the valve under magnetic imaging.

[0171] In one application, the mapping catheter includes electrodes and generating the map includes using the electrodes.

[0172] In one application, the method further includes retrieving the mapping catheter. In one application, retrieving the mapping catheter includes retrieving the mapping catheter prior to implantation, and implanting includes implanting under guidance of the map generated by the mapping catheter. In one application, retrieving the mapping catheter includes retrieving the mapping catheter after implantation.

[0173] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith using a mapping catheter.

[0174] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging an annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a mapping catheter relative to the tissue.

[0175] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of the mapping catheter in response to movement of the tissue.

[0176] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0177] According to some applications, a method is further provided that includes placing an annulus marking device including a radiopaque material in at least an atrium of a heart of a subject, the annulus marking device shaped to define a plurality of expandable elements that radially expand in the atrium, such that the plurality of expandable elements provide an indication of a location of a native heart annulus of the subject's native heart valve. In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning in at least the atrium. The method further includes implanting an implant along the native heart annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. In some applications, the method includes retrieving the annulus marking device after implantation.

[0178] In one application, implanting under imaging includes implanting using fluoroscopy, hi one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0179] In one application, the placing includes placing the annulus marking device in the left atrium, hi one application, the placing includes placing the annulus marking device in the right atrium.

[0180] In one application, the plurality of expandable elements collectively form the annulus marking device into a generally spherical shape, and implanting the implant includes positioning the implant between the annulus marking device and tissue of the atrial wall.

[0181] In one application, the plurality of expandable elements includes a plurality of woven radiopaque fibers in a mesh form.

[0182] In one application, the plurality of expandable elements includes a plurality of curved wires. In one application, implanting the implant includes positioning the implant between the annulus marking device and tissue of the atrial wall and deploying tissue anchors at marked sites between successive curved wires along the annulus.

[0183] In one application, each of the plurality of bowing wires has a proximal end and a distal end and an intermediate section between the proximal and distal ends.

[0184] In one application, a collective proximal diameter of the proximal ends of the multiple expandable elements is equal to a collective distal diameter of the distal ends of the multiple expandable elements, and a collective intermediate diameter of the multiple expandable elements is greater than the collective proximal diameter and greater than the collective distal diameter.

[0185] In one application, the multiple expandable elements collectively form a valve annulus marking device in a partially spherical shape, and implanting the implant includes positioning the implant between the valve annulus marking device and tissue of the atrial wall and deploying tissue anchors at marked sites between successive expandable elements along the valve annulus.

[0186] In one application, the plurality of expandable elements includes a plurality of struts that collectively form a partially spherical stent. In one application, the partially spherical stent includes a plurality of radiopaque filaments coupled to a distal end of the partially spherical stent, and the method further includes viewing tissue of the native heart valve annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0187] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0188] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0189] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0190] In one application, the plurality of expandable elements includes a plurality of curved wires.

[0191] In one application, positioning the annulus marking device includes expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

[0192] In one application, positioning the annulus marking device includes expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within a ventricle of the heart.

[0193] In one application, the multiple expandable elements collectively form an annulus marking device in a partially bulbous shape, and implanting the implant includes positioning the implant between the annulus marking device and tissue of the atrial wall and deploying tissue anchors at marked sites between successive expandable elements along the annulus.

[0194] In one application, the method further includes delivering a radiopaque helical stent between the plurality of expandable elements. In one application, delivering the helical stent includes delivering the helical stent between the native leaflets of the native heart valve. In one application, delivering the helical stent between the native leaflets of the native heart valve includes positioning a distal end of the helical stent within a chamber of the subject's heart.

[0195] In one application, the plurality of expandable elements includes a plurality of curved wires, each of the plurality of curved wires having a proximal end and a distal end and an intermediate section between the proximal and distal ends.

[0196] In one application, a collective proximal diameter of the proximal ends of the multiple expandable elements is smaller than a collective distal diameter of the distal ends of the multiple expandable elements, and a collective intermediate diameter of the multiple expandable elements is larger than the collective proximal diameter and larger than the collective distal diameter.

[0197] In one application, positioning the annulus marking device includes expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

[0198] In one application, positioning the annulus marking device includes expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within a ventricle of the heart.

[0199] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements.

[0200] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the multiple expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the multiple expandable elements relative to the tissue.

[0201] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of expandable elements in response to movement of the tissue.

[0202] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging a plurality of expandable elements relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0203] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to at least a distal end of the annulus marking device, and the method further includes viewing tissue of the native heart annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0204] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0205] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0206] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0207] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0208] According to some applications, there is further provided a system and / or device for use with a subject, the system / device comprising: 1. A valve annulus marking device comprising a radiopaque material, (1) a tubular stent body having a central longitudinal axis and configured to be placed within a subject's native heart valve; (2) a frame coupled to a proximal end of the tubular stent body and projecting away from a longitudinal axis of the stent body, the frame configured to be positioned along at least a portion of a circumference of an annulus of a native heart valve; and the annulus marking device is configured to: compressible during delivery to the native heart valve; a valve annulus marking device expandable from a compressed state for positioning within the native heart valve; an implant for implantation along the annulus of the subject's valve; The annulus marking device is configured to provide a guide for implanting an implant along the annulus and within a space defined by the frame; The implant can be retrieved after implantation.

[0209] In one application, the annulus marking device includes a superelastic material.

[0210] In one application, the stent body and frame are fabricated from a single piece.

[0211] In one application, the tubular stent body includes two or more prosthetic leaflets.

[0212] According to some applications, a method is further provided that includes placing an annulus marking device including a radiopaque material in a native heart valve of a subject, the annulus marking device shaped to define: (1) a tubular stent body having a central longitudinal axis and configured to be placed in the native heart valve of the subject; and (2) a frame coupled to a proximal end of the tubular stent body and projecting away from the longitudinal axis of the stent body, the frame configured to be placed along at least a portion of the circumference of the annulus of the native heart valve. In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning within the native heart valve. The method further includes implanting an implant along the annulus using the annulus marking device as a guide for implanting the implant in a space defined by the frame along the annulus under imaging. Some methods include retrieving the annulus marking device after implantation.

[0213] In one application, implanting under imaging includes implanting using fluoroscopy.

[0214] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0215] In one application, the placing includes placing the annulus marking device in a mitral valve, hi one application, the placing includes placing the annulus marking device in a tricuspid valve.

[0216] In one application, retrieving the annulus marking device after implantation involves sliding the frame proximally around the implant and away from the annulus.

[0217] In one application, the method further includes using the frame to view tissue of the native heart valve annulus and tissue associated therewith.

[0218] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a frame relative to the tissue.

[0219] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the frame in response to movement of the tissue.

[0220] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0221] According to some applications, there is further provided a method that includes positioning an annulus marking device including a radiopaque material within at least an atrium of a subject's heart, the annulus marking device shaped to define a plurality of expandable elements including respective curved sections at a distal end thereof, the plurality of expandable elements configured to radially expand within the atrium, such that the plurality of expandable elements provide an indication of a location of a native heart valve annulus of the subject's native heart valve. In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning within at least the atrium.

[0222] The method can further include implanting an implant within the concave section of each of the plurality of expandable elements along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method can also include retrieving the annulus marking device after implantation.

[0223] In one application, placing the annulus marking device includes placing the annulus marking device when the implant is positioned within the concave section of the plurality of expandable elements.

[0224] In one application, implanting the implant includes disposing the implant within the concave sections of the plurality of expandable elements after placement of the annulus marking device.

[0225] In one application, implanting under imaging includes implanting using fluoroscopy.

[0226] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0227] In one application, retrieving the annulus marking device after implantation includes sliding curved sections of a plurality of expandable elements from beneath the implant.

[0228] In one application, the placing includes placing the annulus marking device in the left atrium, hi one application, the placing includes placing the annulus marking device in the right atrium.

[0229] In one application, positioning the annulus marking device includes expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

[0230] In one application, the multiple expandable elements collectively form a valve annulus marking device in a partially pear-shaped configuration, and implanting the implant includes deploying tissue anchors at marked sites between successive expandable elements along the valve annulus.

[0231] In one application, the multiple expandable elements collectively form a valve annulus marking device in a partially bulbous shape, and implanting the implant includes deploying tissue anchors at marked sites between successive expandable elements along the valve annulus.

[0232] In one application, the plurality of expandable elements includes a plurality of bowing wires, each of the plurality of bowing wires having a proximal end and a distal end and an intermediate section between the proximal and distal ends.

[0233] In one application, a collective proximal diameter of the proximal ends of the multiple expandable elements is smaller than a collective distal diameter of the distal ends of the multiple expandable elements, and a collective intermediate diameter of the multiple expandable elements is larger than the collective proximal diameter and larger than the collective distal diameter.

[0234] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements.

[0235] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the multiple expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the multiple expandable elements relative to the tissue.

[0236] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of expandable elements in response to movement of the tissue.

[0237] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging a plurality of expandable elements relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0238] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to at least a distal end of the annulus marking device, and the method further includes viewing tissue of the native heart annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0239] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0240] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0241] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0242] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0243] According to some applications, there is further provided a method including: positioning a distal end of an annulus marking device including a radiopaque material on a ventricular surface of a native heart valve annulus of a subject, the distal end being shaped to define a curved section that curves upward toward the ventricular surface, facilitating imaging of the heart valve annulus by imaging movement of the distal end of the annulus marking device along a periphery of the ventricular surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may also include retrieving the annulus marking device after implantation.

[0244] In one application, placing the distal end of the annulus marking device on the ventricular surface includes placing the distal end of the annulus marking device on the ventricular surface of a native mitral valve.

[0245] In one application, placing the distal end of the annulus marking device on the ventricular surface includes placing the distal end of the annulus marking device on the ventricular surface of a native tricuspid valve.

[0246] In one application, implanting includes implanting in conjunction with imaging of movement of a distal end of the annulus marking device.

[0247] In one application, the method further includes generating a map of the native heart valve annulus by imaging movement of the distal end of the annulus marking device around a periphery of a ventricular surface of the native heart valve annulus, hi one application, generating the map includes generating the map prior to implantation.

[0248] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0249] According to some applications, there is further provided a method including positioning an annulus marking device including an annular stent including a radiopaque material on a surface of a native heart valve annulus of a subject, facilitating imaging of the heart valve annulus by imaging the movement of a distal end of the annulus marking device along a periphery of a ventricular surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may also include retrieving the annulus marking device after implantation.

[0250] In one application, implanting the implant includes implanting the implant between an outer surface of the annular stent and tissue of the atrial wall.

[0251] In one application, placing on the surface includes placing the annulus marking device on an atrial surface of a native heart valve annulus.

[0252] In one application, the placing includes placing the annulus marking device on a surface of the native mitral valve.In one application, the placing includes placing the annulus marking device on a surface of the native tricuspid valve.

[0253] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

[0254] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0255] In one application, viewing the tissue of the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0256] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0257] In one application, the annular stent includes a plurality of radiopaque filaments coupled to an inner surface of the annular stent, and positioning the annular marking device includes positioning the annular stent along the annulus such that the plurality of radiopaque filaments protrude toward the valve opening, and the method further includes viewing tissue of the native heart valve annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0258] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0259] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0260] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0261] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0262] According to some applications, there is further provided a method including: positioning an annulus marking device including an implant guidance device including a radiopaque material on a surface of a native heart valve annulus of a subject, facilitating imaging of the heart valve annulus by imaging movement of the implant guidance device along a periphery of the surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the implant guidance device as a guide for positioning and implanting the implant along the annulus under imaging. The method may also include retrieving the annulus marking device after implantation.

[0263] In one application, positioning the annulus marking device includes advancing the annulus marking device along the implantation pathway upstream of the implant.

[0264] In one application, the placing includes placing the annulus marking device on a surface of the native mitral valve.In one application, the placing includes placing the annulus marking device on a surface of the native tricuspid valve.

[0265] In one application, the positioning includes positioning the annulus marking device such that a portion of the annulus marking device spans a portion of the valve opening.

[0266] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

[0267] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0268] In one application, viewing the tissue of the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0269] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0270] In one application, the implant guide device includes a plurality of radiopaque filaments coupled to the implant guide device, and the method further includes viewing tissue of the native heart valve annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0271] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0272] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0273] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0274] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0275] According to some applications, there is further provided a method including: placing an annulus marking device including a looped wire including a radiopaque material on a surface of a native heart valve annulus of a subject, facilitating imaging of the heart valve annulus by imaging movement of the wire along at least a portion of the circumference of the surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the wire as a guide for implanting the implant along the annulus under imaging upon placement. The method may also include retrieving the annulus marking device after implantation.

[0276] In one application, implanting under imaging includes implanting using fluoroscopy.

[0277] In one application, positioning the annulus marking device includes advancing the annulus marking device along the implantation pathway upstream of the implant.

[0278] In one application, the placing includes placing the annulus marking device on a surface of the native mitral valve.In one application, the placing includes placing the annulus marking device on a surface of the native tricuspid valve.

[0279] In one application example, the placing includes pressing a first portion of the annulus marking device against a first portion of the valve annulus, thereby pressing a second portion of the annulus marking device opposite the first portion of the annulus marking device against a second portion of the valve annulus.

[0280] In one application, implanting the implant includes implanting the implant around a circumference of the annulus marking device in response to a pressure.

[0281] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

[0282] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0283] In one application, viewing the tissue of the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0284] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0285] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to the annulus marking device, and the method further includes viewing tissue of the native heart annulus and tissue coupled thereto using the plurality of radiopaque filaments.

[0286] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0287] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0288] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0289] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0290] According to some applications, there is further provided a method that includes deploying, within tissue of a subject's native heart valve annulus, a valve annulus marking device including a plurality of radiopaque pins including a radiopaque material, facilitating imaging of the heart valve annulus by imaging the plurality of pins, and then implanting an implant along the subject's native heart valve annulus using the plurality of pins as a guide for implanting the implant along the annulus under imaging.

[0291] In one application, each of the plurality of pins has a barb configured to anchor to tissue of the valve annulus.

[0292] In one application example, each of the plurality of pins has a maximum width of 0.5 to 3.0 mm.

[0293] In one application, facilitating imaging of a heart valve annulus by imaging a plurality of pins includes facilitating imaging movement of the plurality of pins in response to movement of the valve annulus.

[0294] In one application, implanting the implant includes deploying a plurality of tissue anchors to fasten the implant to tissue of the valve annulus.

[0295] In one application, deploying the plurality of tissue anchors includes deploying a number of tissue anchors greater than the number of pins.

[0296] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0297] According to some applications, a method is further provided that includes positioning an annulus marking device including a plurality of radiopaque pins movable proximally and distally in response to variations in the valve tissue topography in tissue tissue of a native heart valve of a subject, facilitating imaging of the heart valve annulus and tissue associated therewith by moving the plurality of pins along the native heart valve and imaging the plurality of pins to generate an image of the heart valve topography, and implanting an implant along the subject's native heart valve annulus using the image as a guide for implanting the implant along the annulus under imaging. The method may further include retrieving the plurality of radiopaque pins from the subject.

[0298] In one application, harvesting includes harvesting after implantation. In one application, harvesting includes harvesting before implantation.

[0299] In one application, facilitating imaging of the heart valve annulus by imaging the pins includes facilitating imaging movement of the pins in response to movement of the annulus. In one application, implanting includes implanting while facilitating imaging. In one application, facilitating imaging includes viewing proximal movement of the pins in response to movement of the pins over a peak of tissue of the annulus.

[0300] In one application, facilitating imaging includes viewing proximal movement of at least a first portion of the plurality of pins in response to movement of the plurality of pins past tissue of the valve annulus, and viewing at least a second portion of the plurality of pins that are not moving in response to movement of the plurality of pins past tissue of the atrial wall.

[0301] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0302] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including a multi-lumen tube, and at least a first annulus marking device is expandable from within the multi-lumen tube.

[0303] For some applications, the at least first annulus marking device includes a distal frame wire, the distal frame wire having an expanded shape and assuming a generally linear configuration when the annulus marking device is in an expanded state. For some applications, the at least first annulus marking device includes a plurality of radiopaque filaments coupled to the distal frame wire, the plurality of radiopaque filaments comprising a radiopaque material and protruding away from the distal frame wire in the expanded state of the annulus marking device.

[0304] In some applications, at least one central rod is coupled to an intermediate portion of the distal frame wire and is primarily positioned within and slidable within the primary secondary lumen of the multi-lumen tube, and the central rod is configured to restrain the distal frame wire and the multiple radiopaque filaments from an expanded state of the annulus marking device and to pull the distal frame wire and the multiple radiopaque filaments within the primary secondary lumen of the multi-lumen tube.

[0305] In some applications, at least two peripheral wires are coupled at both ends to the distal frame wire, the at least two peripheral wires are primarily positioned within and slidable within respective secondary minor lumens of the multi-lumen tube, and the at least two peripheral wires are configured to stabilize the distal frame wire in the expanded state of the annulus marking device.

[0306] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from the compressed state for positioning along the native heart valve annulus.

[0307] In some applications, the system / apparatus further comprises an implant for implantation along the subject's native heart valve annulus, wherein the annulus marking device is configured to provide a guide for implanting the implant along the annulus during implantation.

[0308] In some applications, the annulus marking device is retrievable after implantation of the implant.

[0309] In one application, the multi-lumen tube is shaped to define a central lumen, and the implant is configured to be delivered to the heart valve annulus via the central lumen.

[0310] In one application, the peripheral wires are configured to follow behind the distal frame wire as the central rod pulls the distal frame wire and the plurality of radiopaque filaments within a primary secondary lumen of the multi-lumen tube.

[0311] In one application, each of the plurality of radiopaque filaments and the distal frame wire comprises a flexible material.

[0312] In one application, the at least first annulus marking device includes at least first and second annulus marking devices, the multi-lumen tube is shaped to define first and second primary minor lumens, and the multi-lumen tube is shaped to define four secondary minor lumens.

[0313] In some applications, the apparatus includes first and second central rods configured to constrain the first and second annulus marking devices within the respective first and second primary minor lumens, respectively. In some applications, the apparatus includes four peripheral wires configured to stabilize distal frame wires of the respective first and second annulus marking devices, respectively, the four peripheral wires being slidable within the four secondary minor lumens.

[0314] In one application, the first and second annulus marking devices are independently controllable by respective first and second control rods.

[0315] In one application, the at least first annulus marking device includes first, second, third, and fourth annulus marking devices, the multi-lumen tube is shaped to define first, second, third, and fourth primary minor lumens, the multi-lumen tube is shaped to define eight secondary minor lumens, the apparatus includes first, second, third, and fourth central rods configured to restrain the first, second, third, and fourth annulus marking devices within the respective first, second, third, and fourth primary minor lumens, respectively, and the apparatus includes eight peripheral wires configured to stabilize distal frame wires of the respective first, second, third, and fourth annulus marking devices, respectively, the eight peripheral wires being slidable within the eight secondary minor lumens.

[0316] In one application, the first, second, third, and fourth annulus marking devices are independently controllable by respective first, second, third, and fourth control rods.

[0317] According to some applications, there is further provided a method including delivering a distal end of a central multi-lumen tube within a cardiac cavity of a subject, magnifying at least a first annulus marking device from within the multi-lumen tube, and implanting an implant along a native heart annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may include retrieving the annulus marking device after implantation.

[0318] For some applications, at least the first annulus marking device includes a distal frame wire, the distal frame wire having an expanded shape and assuming a generally linear configuration when the annulus marking device is in an expanded state. In some applications, a plurality of radiopaque filaments are coupled to the distal frame wire, the plurality of radiopaque filaments comprising a radiopaque material and protruding away from the distal wire in the expanded state of the annulus marking device.

[0319] In some applications, the method includes controlling a position of at least a first annulus marking device within a primary minor lumen of the multi-lumen tube by sliding at least one central rod coupled to an intermediate portion of the distal frame wire and positioned primarily within the primary minor lumen of the multi-lumen tube.

[0320] In some applications, the method includes stabilizing the distal frame wire with at least two peripheral wires coupled to the distal frame wire at both ends thereof, the at least two peripheral wires being primarily positioned within and slidable within respective secondary minor lumens of the multi-lumen tube, the at least two peripheral wires being configured to stabilize the distal frame wire in an expanded state of the annulus marking device.

[0321] In some applications, the method includes constraining the annulus marking device by pulling on a central rod to constrain the distal frame wire and the multiple radiopaque filaments from an expanded state of the annulus marking device, and pulling the distal frame wire and the multiple radiopaque filaments within a primary secondary lumen of the multi-lumen tube.

[0322] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from the compressed state for positioning along the native heart valve annulus.

[0323] In one application, the multi-lumen tube is shaped to define a central lumen, and the method further includes delivering the implant to the heart valve annulus via the central lumen.

[0324] In one application, constraining the annulus marking device by pulling on the central rod includes allowing the peripheral wires to follow behind the distal frame wire as the central rod pulls on the distal frame wire and the multiple radiopaque filaments within a primary secondary lumen of the multi-lumen tube.

[0325] In one application, each of the plurality of radiopaque filaments and the distal frame wire comprises a flexible material.

[0326] In one application, controlling the position of the at least first annulus marking device includes positioning the at least first annulus marking device along an annulus of the mitral valve.

[0327] In one application, controlling the position of the at least first annulus marking device includes positioning the at least first annulus marking device along an annulus of a tricuspid valve.

[0328] In one application, the at least first annulus marking device includes at least first and second annulus marking devices, the multi-lumen tube is shaped to define first and second primary minor lumens, the multi-lumen tube is shaped to define four secondary minor lumens, and the method further includes constraining the first and second annulus marking devices within the respective first and second primary minor lumens by pulling the respective first and second control rods. In some applications, the method further includes stabilizing the wires of the respective first and second annulus marking devices using four circumferential wires slidable within the four secondary minor lumens.

[0329] In one application, the method further includes independently controlling the first and second annulus marking devices using respective first and second control rods.

[0330] In one application, the at least first annulus marking device includes a first, second, third, and fourth annulus marking device, the multi-lumen tube is shaped to define first, second, third, and fourth primary minor lumens, and the multi-lumen tube is shaped to define eight secondary minor lumens, and the method further includes constraining the first, second, third, and fourth annulus marking devices within the respective second, third, and fourth primary minor lumens by pulling the respective first, second, third, and fourth control rods. In some applications, the method further includes stabilizing distal frame wires of the respective second, third, and fourth annulus marking devices with eight circumferential wires slidable within the eight secondary minor lumens, respectively.

[0331] The method may further include independently controlling the first, second, third, and fourth annulus marking devices using respective first and second control rods.

[0332] In one application, the method further includes viewing the tissue of the native heart valve annulus and tissue associated therewith using a plurality of radiopaque filaments.

[0333] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0334] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of a plurality of radiopaque filaments in response to movement of the tissue.

[0335] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0336] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0337] According to some applications, there is further provided a method including: placing an annulus marking device including a radiopaque material shaped to define a plurality of expandable fingers at a native heart valve annulus of a subject, the annulus marking device being in a compressed state during delivery to the native heart valve and expandable from the compressed state for positioning along the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may include retrieving the annulus marking device after implantation.

[0338] In one application, placing the annulus marking device includes delivering the annulus marking device using a delivery tool, the annulus marking device surrounding the tool, and implanting the implant includes delivering the implant through a lumen of the tool surrounded by the annulus marking device.

[0339] In one application, placing the annulus marking device includes measuring annulus height using the annulus marking device.

[0340] In one application, implanting under imaging includes implanting using fluoroscopy.

[0341] In one application, retrieving the annulus marking device after implantation includes deflating the annulus marking device to constrain the annulus marking device within a tool, and extracting the annulus marking device from the subject.

[0342] In one application, the placing includes placing the annulus marking device along the annulus of a mitral valve.In one application, the placing includes placing the annulus marking device along the annulus of a tricuspid valve.

[0343] In one application, implanting using the annulus marking device as a guide involves viewing the shape of each of the multiple fingers.

[0344] In one application, viewing the shape includes determining that the annulus marking device is located at the annulus in response to viewing a bend in at least one of the plurality of fingers.

[0345] In one application, viewing the shape includes determining that the annulus marking device is located at at least a portion of the valve leaflet in response to viewing movement of at least one of the plurality of fingers in response to movement of at least one of the plurality of fingers.

[0346] In one application, the method further includes expanding the plurality of fingers prior to deployment, hi one application, the expanding includes expanding the plurality of fingers with a radiopaque fluid.

[0347] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the multiple fingers.

[0348] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging a plurality of fingers relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of fingers relative to the tissue.

[0349] In one application, viewing the tissue of the native heart valve annulus includes imaging the multiple fingers relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the multiple fingers in response to movement of the tissue.

[0350] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0351] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0352] According to some applications, there is further provided a system and / or apparatus for use with a subject, the system / apparatus including a valve annulus marking device including a radiopaque material, the valve annulus marking device shaped to define: (1) a plurality of concentric wire loops connected by a scaffold configured to be placed at an opening of a native heart valve of the subject; and (2) a wire loop frame coupled to the scaffold and concentric to the plurality of concentric wire loops, the wire loop frame configured to be placed along at least a portion of a circumference of an annulus of the native heart valve.

[0353] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from a compressed state for positioning within the native heart valve.

[0354] For some applications, the system / device further includes an implant for implantation along the annulus of the subject valve.

[0355] In some applications, the annulus marking device is configured to provide a guide for implanting an implant along the annulus and within the space defined by the frame, hi some applications, the annulus marking device is retrievable after implantation of the implant.

[0356] In one application, the annulus marking device includes a superelastic material.In one application, the multiple concentric wire loops, the scaffold, and the wire loop frame are fabricated from a single piece.

[0357] In one application, the valve annulus marking device includes a plurality of radiopaque filaments coupled at least to a plurality of concentric wire loops, each of the plurality of filaments configured to oscillate in response to movement of blood through an opening of the valve to provide an indication of the location of a leaflet of the valve.

[0358] In one application, the annulus marking device includes a locking ring within the center of a plurality of concentric wire loops, the locking ring being compressible distally to lock the annulus marking device in the expanded state.

[0359] In one application, the device further includes a plurality of radiopaque filaments coupled to the plurality of concentric wire loops, the plurality of radiopaque filaments including a radiopaque material.

[0360] In one application, the plurality of radiopaque filaments are configured to move in response to movement of the native heart valve, thereby providing an indication of the location of the valve leaflets.

[0361] According to some applications, there is further provided a method that includes placing an annulus marking device comprising a radiopaque material on a subject's native heart valve, the annulus marking device shaped to define (1) a plurality of concentric wire loops connected by a scaffolding material, and (2) a wire loop frame coupled to the scaffolding material and concentric with the plurality of concentric wire loops, the wire loop frame configured to be positioned along at least a portion of a circumference of an annulus of the native heart valve.

[0362] In some applications, the annulus marking device is compressible to a compressed state during delivery to the native heart valve and expandable from the compressed state to an expanded state for positioning within the native heart valve.

[0363] In some applications, the method includes implanting an implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus and within a space defined by the frame under imaging, hi some applications, the method includes retrieving the annulus marking device after implantation.

[0364] In one application, the method further includes locking the annulus marking device in the expanded state by distally depressing a locking ring disposed within a center of the plurality of concentric wire loops.

[0365] In one application, the method further includes transitioning the annulus marking device from a compressed state to an expanded state by distally depressing a locking ring disposed within a center of the plurality of concentric wire loops.

[0366] In one application, implanting under imaging includes implanting using fluoroscopy.

[0367] In one application, the placing includes placing an annulus marking device at the mitral valve, placing a plurality of concentric wire loops at an opening of the valve, and placing a wire loop frame along at least a portion of a circumference of the mitral valve annulus.

[0368] In one application, the placing includes placing an annulus marking device in the tricuspid valve, placing a plurality of concentric wire loops in the valve opening, and placing a wire loop frame along at least a portion of a circumference of the tricuspid valve annulus.

[0369] In one application, retrieving the annulus marking device after implantation involves sliding the frame proximally around the implant and away from the annulus.

[0370] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith using an annulus marking device.

[0371] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0372] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0373] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to a plurality of concentric wire loops, and the method further includes determining that the annulus marking device is located at least a portion of a valve leaflet in response to viewing movement of at least some of the plurality of radiopaque filaments in response to valve movement.

[0374] In one application, the method further includes determining that the annulus marking device is located at least in a portion of the annulus in response to viewing a lack of movement of at least a first portion of the plurality of radiopaque filaments when a second portion of the plurality of radiopaque filaments is moving in response to valve movement.

[0375] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0376] In one application, retrieving the annulus marking device includes transitioning the annulus marking device from an expanded state to a compressed state by pulling proximally a locking ring disposed within the center of a plurality of concentric wire loops.

[0377] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0378] According to some applications, there is further provided a method including: placing an annulus marking device including a radiopaque material in a native heart valve annulus of a subject, the annulus marking device being shaped to define a plurality of radiopaque petals or loops, the annulus marking device being in a compressed state during delivery to the native heart valve and being expandable from the compressed state for positioning along the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The method may include retrieving the annulus marking device after implantation.

[0379] In one application, placing the annulus marking device includes delivering the annulus marking device using a delivery tool, the annulus marking device surrounding the tool, and implanting the implant includes delivering the implant through a lumen of the tool surrounded by the annulus marking device.

[0380] In one application, placing the annulus marking device includes measuring annulus height using the annulus marking device.

[0381] In one application, implanting under imaging includes implanting using fluoroscopy.

[0382] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0383] In one application, the placing includes placing an annulus marking device along the annulus of the mitral valve.

[0384] In one application, the placing includes placing an annulus marking device along an annulus of a tricuspid valve.

[0385] In one application, at least one of the plurality of petals or loops is a larger petal or loop than the other petals or loops, and placing includes placing the annulus marking device within the valve such that the larger petal or loop is positioned between the leaflets of the valve.

[0386] In one application, implanting using the annulus marking device as a guide involves viewing the shape of each of the multiple petals or loops.

[0387] In one application, viewing the shape includes determining that the annulus marking device is located at the annulus in response to viewing a bend in at least one of the plurality of petals or loops.

[0388] In one application, viewing the shape includes determining that the annulus marking device is located at at least a portion of the valve leaflet in response to viewing movement of at least one of the plurality of petals or loops in response to movement of at least one of the plurality of petals or loops.

[0389] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith under imaging of the multiple petals or loops.

[0390] In one application, viewing the tissue of the native heart valve annulus and associated tissue includes imaging a plurality of petals or loops relative to the tissue of the native heart valve annulus and associated tissue by viewing a plurality of petals or loops relative to the tissue.

[0391] In one application, viewing the tissue of the native heart valve annulus includes imaging the plurality of petals or loops relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of petals or loops in response to movement of the tissue.

[0392] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0393] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0394] According to some applications, there is further provided a system and / or apparatus that includes a guidewire having a distal end, the guidewire configured to assume a shape in an expanded state of the guidewire, and an annulus marking device including a plurality of radiopaque filaments coupled to the distal end of the guidewire.

[0395] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0396] In one application, the device further includes a tube, and the distal end of the guidewire at least partially surrounds a portion of the tube in the expanded state of the guidewire.

[0397] In one application, the apparatus further includes an implant deliverable through the lumen of the tube, the plurality of radiopaque filaments configured to guide implantation of the implant.

[0398] According to some applications, a method is further provided that includes positioning a distal end of a guidewire within a heart lumen of a subject, the guidewire configured to assume a shape in an expanded state of the guidewire, the distal end of the guidewire being coupled to a valve annulus marking device including a plurality of radiopaque filaments; moving the distal end of the guidewire along tissue surrounding the heart lumen; and imaging the tissue surrounding the heart lumen by viewing the movement of the distal end of the guidewire and the plurality of radiopaque filaments.

[0399] In one application, moving the distal end of the guidewire along the tissue includes measuring the height of the native annulus of the heart valve using an annulus marking device.

[0400] In one application, the imaging includes imaging using fluoroscopy.

[0401] In one application, positioning the distal end of the guidewire includes positioning the distal end of the guidewire along the annulus of a mitral valve, hi one application, positioning the distal end of the guidewire includes positioning the distal end of the guidewire along the annulus of a tricuspid valve.

[0402] In one application, positioning the distal end of the guidewire includes positioning the distal end of the guidewire within a sub-annular space of a subject's native heart valve.

[0403] In one application, imaging the tissue surrounding the lumen includes using a plurality of radiopaque filaments to view the tissue of the native heart valve annulus and tissue associated therewith.

[0404] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing a plurality of radiopaque filaments against the tissue.

[0405] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0406] In one application, the method further includes implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging, hi one application, the method includes retrieving the annulus marking device after implantation.

[0407] In one application, the implant is delivered through a tube, a distal end of a guidewire encircles a portion of the tube, and implanting the implant along a subject's native heart valve annulus includes guiding the portion of the tube along the annulus using a valve annulus marking device.

[0408] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0409] According to some applications, there is further provided a method that includes expanding, within an atrium of a subject's heart, an annulus marking device including a radiopaque material, the annulus marking device shaped to define (1) a first radiopaque loop and (2) a second radiopaque loop configured to pivot and tilt relative to the first radiopaque loop. The method can include tilting the second radiopaque loop relative to the first radiopaque loop and allowing the second radiopaque loop to pivot along a plane that forms a non-zero angle with respect to a plane of the first radiopaque loop.

[0410] In some applications, the method includes positioning the annulus marking device at least partially within a native heart valve of the heart in a fully expanded state such that (1) a first radiopaque loop is disposed between the leaflets of the native heart valve, an upper portion of the first radiopaque loop is disposed within the atrium, a lower portion of the first radiopaque loop is disposed within the ventricle of the heart, and (2) a second radiopaque loop is disposed along an atrial surface of an annulus of the valve.

[0411] In some applications, the annulus marking device is compressible to a compressed state during delivery to the native heart valve and expandable from the compressed state to an expanded state for positioning within the native heart valve, and the method further includes implanting an implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. In some applications, the method includes retrieving the annulus marking device after implantation.

[0412] In one application, implanting under imaging includes implanting using fluoroscopy.

[0413] In one application, the positioning includes positioning the annulus marking device on the mitral valve.In one application, the positioning includes positioning the annulus marking device on the tricuspid valve.

[0414] In one application, retrieving the annulus marking device after implantation includes pivoting and tilting the second radiopaque loop relative to the first radiopaque loop.

[0415] In one application, the positioning includes positioning a first radiopaque loop between the valve leaflets and applying a force to a commissure of the valve by the first radiopaque loop with the positioning.

[0416] In one application, the first and second radiopaque loops each include a wire frame at least partially surrounded by a respective radiopaque spring, and positioning the annulus marking device includes allowing the spring to be compressed and expanded.

[0417] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0418] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith using an annulus marking device.

[0419] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0420] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0421] In one application, the method further includes moving a second radiopaque loop vertically along a portion of the first radiopaque loop in a fully expanded state of the annulus marking device.

[0422] In one application, moving the second radiopaque loop vertically along a portion of the first radiopaque loop includes measuring annulus height.

[0423] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0424] According to some applications, there is further provided a system and / or apparatus including an annulus marking device including a central rod, two or more expandable wires connected to the central rod at respective proximal and distal ends, each shaped to define a concave-convex section that conforms to a native heart annulus of a target valve, and at least one ultrasonic transducer rotatably slidable along and relative to the central rod. In some applications, the annulus marking device is compressible to a compressed state during delivery to the native heart valve and expandable from the compressed state to an expanded state for positioning within the native heart valve.

[0425] In one application, the apparatus further includes an implant implantable into the annulus under guidance from imaging using the annulus marking device.

[0426] In one application, the central rod is hollow and the at least one ultrasonic transducer is disposed within the central rod.

[0427] In one application, the device further includes at least one radiopaque marker slidable along the two or more expandable elements until the radiopaque marker abuts the valve annulus.

[0428] In one application, the at least one radiopaque marker includes a wiring.

[0429] In one application, the at least one radiopaque marker includes a plurality of radiopaque filaments coupled to a wiring ring.

[0430] According to some applications, there is further provided a method that includes expanding an annulus marking device within a subject's native heart valve, the annulus marking device shaped to define two or more expandable wires connected at respective proximal and distal ends to a central rod, each of the two or more expandable wires shaped to define an irregular section that conforms to the native heart annulus of the valve.

[0431] In some applications, the annulus marking device is compressible to a compressed state during delivery to the native heart valve and expandable from the compressed state to an expanded state for positioning within the native heart valve.

[0432] In some applications, the method includes sliding at least one ultrasound transducer along and relative to the central rod in a rotational manner, imaging an annulus of the valve using the ultrasound transducer, and implanting an implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. In some applications, the method includes retrieving the annulus marking device after implantation.

[0433] In one application, the imaging includes measuring annulus height.

[0434] In one application, the expanding includes expanding an annulus marking device at the mitral valve.

[0435] In one application, the expanding includes expanding an annulus marking device at a tricuspid valve.

[0436] In one application, the expanding includes expanding two or more expandable wires between the leaflets of the valve and applying a force to the commissures of the valve by the two or more expandable wires upon the expanding.

[0437] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0438] In one application, the expanding includes positioning the annulus marking device within a native heart valve of the heart such that two or more expandable wires are positioned between the leaflets of the native heart valve, with an upper portion of each expandable wire being positioned within an atrium and a lower portion of each expandable wire being positioned within a ventricle.

[0439] In one application, the method includes: sliding the radiopaque marker vertically along the two or more expandable elements until the radiopaque marker abuts the valve annulus; and imaging the annulus under fluoroscopy.

[0440] In one application, sliding the radiopaque marker includes measuring annulus height.

[0441] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith using an annulus marking device.

[0442] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0443] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0444] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0445] According to some applications, a method is further provided that includes positioning an annulus marking device including a clip within a ventricle of a subject's heart, the clip including a radiopaque material, first and second clamps coupled together at a hinge point, each having an end, and first and second filaments extending from the respective ends of the first and second clamps.

[0446] The method can include using a clip to clip together first and second leaflets of a subject heart valve, and allowing the clipping to cause a first filament to abut an atrial surface of at least one of the first and second leaflets such that an end of the first filament is positioned near an atrial wall and near a hinge of an annulus of the valve, and a second filament to abut a ventricular surface of at least one of the first and second leaflets such that an end of the second filament is positioned near a ventricular wall and within a semi-annular groove of the valve.

[0447] The method may further include implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0448] In one application, the method further includes retrieving the annulus marking device after implantation.

[0449] In one application, the first and second filaments include a superelastic material.

[0450] In one application, the fastening includes implanting an annulus marking device.

[0451] In one application, the implanting includes attaching at least one of the first and second filaments to the valve.

[0452] In one application, implanting under imaging includes implanting using fluoroscopy.

[0453] In one application, positioning the annulus marking device within the ventricle includes positioning the annulus marking device within a right ventricle and fastening the leaflets together includes fastening the leaflets of a tricuspid valve, hi one application, positioning the annulus marking device within the ventricle includes positioning the annulus marking device within a left ventricle and fastening the leaflets together includes fastening the leaflets of a mitral valve.

[0454] In one application, the fastening includes creating a double opening in the mitral valve.

[0455] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith using the first and second filaments.

[0456] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing first and second filaments against the tissue.

[0457] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the first and second filaments in response to movement of the tissue.

[0458] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0459] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0460] According to some applications, a method is further provided that includes positioning an annulus marking device including a clamp within a ventricle of a subject's heart, the clamp including a radiopaque material, first and second arms coupled together at a hinge point, each having an end, and first and second curved elements coupled to the respective ends of the first and second arms.

[0461] The method may further include using the clamp to clamp a leaflet of the subject heart valve between the first and second arms, and clamping to allow the first curved element to abut an atrial surface of the leaflet near a hinge of the annulus of the valve near the atrial wall and the second curved element to abut a ventricular surface of the leaflet within a semi-annular groove of the valve near a ventricular wall.

[0462] The method may further include implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0463] In one application, the method further includes retrieving the annulus marking device after implantation.

[0464] In one application, implanting under imaging includes implanting using fluoroscopy.

[0465] In one application, positioning the annulus marking device within the ventricle includes positioning the annulus marking device within a right ventricle and clamping includes clamping leaflets of a tricuspid valve.

[0466] In one application, positioning the annulus marking device within the ventricle includes positioning the annulus marking device within the left ventricle and clamping includes clamping leaflets of the mitral valve.

[0467] In one application, the method further includes using the first and second curved elements to view tissue of the native heart valve annulus and tissue associated therewith.

[0468] In one application example, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the first and second curved elements relative to the tissue.

[0469] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the first and second curved elements in response to movement of the tissue.

[0470] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0471] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0472] According to some applications, there is further provided a method that includes delivering an annulus marking device including a balloon into a native heart valve of a subject's heart, and implanting an implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0473] The balloon can be the same as or similar to other expandable elements and / or balloons described herein. In some applications, the balloon includes an upper inflatable section inflatable to assume a generally paddle shape, a lower inflatable section inflatable to assume a spherical shape, and a central waist between the upper and lower inflatable sections.

[0474] In some applications, the method includes positioning the balloon such that the upper inflatable section is disposed within the atrium of the heart, the lower inflatable section is disposed within the ventricle of the heart, and the central waist is disposed between the leaflets of the valve.

[0475] For some applications, the method includes inflating the balloon such that the upper inflatable section expands to assume a generally paddle shape and the lower inflatable section expands to assume a spherical shape.

[0476] In one application, the implanting includes implanting an implant between an outer surface of the upper expandable element and an atrial wall of the heart.

[0477] In one application, the method further includes retrieving the annulus marking device after implantation.

[0478] In one application, the top surface of the upper inflatable section is sloped.

[0479] In one application, implanting under imaging includes implanting using fluoroscopy.

[0480] In one application, the balloon is shaped to define an hourglass shape in at least one cross section thereof.

[0481] In one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in a mitral valve, hi one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in a tricuspid valve.

[0482] In one application, the upper inflatable section is less flexible than the lower inflatable section, hi one application, the upper inflatable section is inflexible.

[0483] In one application, the method further includes using the balloon to view tissue of the native heart valve annulus and tissue associated therewith.

[0484] In one application, the balloon includes a radiopaque material, hi one application, inflating the balloon includes inflating the balloon with a radiopaque fluid.

[0485] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the upper and lower expandable elements relative to the tissue.

[0486] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0487] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0488] According to some applications, there is further provided a method including delivering an annulus marking device including a balloon within a ventricle of a native heart valve of a subject's heart, inflating the balloon within the ventricle, and implanting an implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. In some applications, the method includes retrieving the annulus marking device after implantation.

[0489] In one application, the inflating includes inflating the balloon to assume a spherical shape. In one application, the inflating includes inflating the balloon to assume a toroidal shape.

[0490] In one application, implanting under imaging includes implanting using fluoroscopy.

[0491] In one application, delivering the annulus marking device within the ventricle includes positioning the annulus marking device within the left ventricle, hi one application, delivering the annulus marking device within the ventricle includes positioning the annulus marking device within the right ventricle.

[0492] In one application, the balloon includes a magnetic material within a space defined by the balloon, and implanting under imaging includes attracting the magnetic material to an upper surface of the balloon and marking the annulus of the valve from the ventricular surface of the valve.

[0493] In one application example, delivering the annulus marking device includes delivering the annulus marking device using a delivery tool including a magnet, and attracting the magnetic material to the upper surface of the balloon includes using the magnet of the delivery tool.

[0494] In one application, the magnet includes a circular magnet, and delivering the annulus marking device using the delivery tool includes positioning the magnet on an atrial surface of the valve, and implanting the implant includes implanting the implant between an outer surface of the magnet and the atrial wall.

[0495] In one application, the method further includes using the balloon to view tissue of the native heart valve annulus and tissue associated therewith.

[0496] In one application, the balloon includes a radiopaque material, hi one application, inflating the balloon includes inflating the balloon with a radiopaque fluid.

[0497] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the balloon relative to the tissue.

[0498] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0499] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0500] According to some applications, there is further provided a method including delivering an annulus marking device within a native heart valve of a subject's heart and implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging. The annulus marking device can be the same as or similar to other annulus marking devices described herein.

[0501] In some applications, the annulus marking device includes an upper expandable element expandable to assume a first annular shape and a lower expandable element expandable to assume a second annular shape. In some applications, the method includes positioning the annulus marking device such that the upper expandable element is disposed within an atrium of the heart and the lower expandable element is disposed within a ventricle of the heart, and expanding the upper and lower expandable elements such that the upper expandable element expands to assume the first annular shape and the lower expandable element expands to assume the second annular shape.

[0502] In one application, the implanting includes implanting an implant between an outer surface of the upper expandable element and an atrial wall of the heart.

[0503] In one application, the method further includes retrieving the annulus marking device after implantation.

[0504] In one application, implanting under imaging includes implanting using fluoroscopy.

[0505] In one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in a mitral valve, hi one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in a tricuspid valve.

[0506] In one application, the upper and lower expandable elements include a compliant material. In one application, the upper and lower expandable elements include a non-compliant material.

[0507] In one application, the upper and lower expandable elements are separate.

[0508] In one application, the annulus marking device includes a single balloon including upper and lower inflatable elements bonded together. In one application, the balloon includes a central waist between the upper and lower inflatable elements. In one application, the balloon is shaped to define an hourglass shape in at least one cross section thereof.

[0509] In one application, positioning the annulus marking device includes positioning a central waist between the leaflets of the valve.

[0510] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith using an annulus marking device.

[0511] In one application, the annulus marking device includes a radiopaque material.

[0512] In one application, inflating the annulus marking device includes inflating the annulus marking device with a radiopaque fluid.

[0513] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the upper and lower expandable elements relative to the tissue.

[0514] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0515] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0516] According to some applications, there is further provided a method including delivering an annulus marking device including at least a first magnetic element to one or more surfaces of a native heart valve of a subject's heart, the one or more surfaces being selected from the group consisting of an atrial surface and a ventricular surface; generating a magnetic field around the at least the first magnetic element; and implanting an implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0517] The method may also include retrieving the annulus marking device after implantation.

[0518] In one application, the at least first magnetic element includes a circular wire. In one application, the at least first magnetic element includes a flat disk. In one application, the at least first magnetic element includes an annular body.

[0519] In one application, generating the magnetic field includes preventing movement of the magnetic element relative to the tissue of the valve.

[0520] In one application, generating the magnetic field includes positioning a magnetic element in a suitable location relative to the tissue of the valve.

[0521] In one application, implanting under imaging includes implanting using fluoroscopy.

[0522] In one application, delivering the annulus marking device includes delivering the annulus marking device to a mitral valve.In one application, delivering the annulus marking device includes delivering the annulus marking device to a tricuspid valve.

[0523] In one application, generating a magnetic field around at least the first magnetic element includes providing an external magnetic field.

[0524] In one application, delivering the annulus marking device includes positioning at least a first magnetic element on an atrial surface, and generating a magnetic field includes generating a magnetic field from within a ventricle of the heart.

[0525] In one application, delivering the annulus marking device includes positioning at least a first magnetic element on a ventricular surface, and generating the magnetic field includes generating a magnetic field from within an atrium of the heart.

[0526] In one application, delivering at least a first magnetic element includes delivering a first magnetic element to an atrial surface of the valve. In one application, the method further includes delivering a second magnetic element to a ventricular surface of the valve, and generating the magnetic field includes generating the magnetic field in response to delivering the second magnetic element.

[0527] In one application, implanting the implant includes implanting the implant between an outer surface of the first magnetic element and the atrial wall.

[0528] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith using at least a first magnetic element.

[0529] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a first magnetic element relative to the tissue.

[0530] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0531] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0532] According to some applications, there is further provided a method including: positioning an annulus marking device including a coiled wire including a radiopaque material on a surface of a native heart valve annulus of a subject, facilitating imaging of the heart valve annulus by imaging movement of the coiled wire along at least a portion of the circumference of the surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the subject using the coiled wire as a guide for implanting the implant along the annulus under imaging upon positioning. The method also includes retrieving the annulus marking device after implantation.

[0533] In one application, implanting under imaging includes implanting using fluoroscopy.

[0534] In one application, the placing includes placing the annulus marking device on a surface of the native mitral valve.In one application, the placing includes placing the annulus marking device on a surface of the native tricuspid valve.

[0535] In one application, the placing includes (1) anchoring a first end of the coiled wire to a first commissure of the valve, (2) allowing the coiled wire to expand along a portion of a circumference of the valve, and (3) anchoring a second end of the coiled wire to a second commissure of the valve.

[0536] In one application, allowing the coiled wire to expand along a portion of the circumference of the valve includes applying a compressive force to a portion of the annulus at the portion of the circumference of the valve.

[0537] In one application example, the placing includes placing the annulus marking device along an atrial surface of the valve, and (1) anchoring a first end of the coiled wire to a first commissure of the valve includes anchoring the first end to the first commissure using a first anchor that locks it in place at the first commissure within the ventricle of the subject's heart, and (2) anchoring a second end of the coiled wire to a second commissure of the valve includes anchoring the second end to the second commissure using a second anchor that locks it in place at the second commissure within the ventricle of the subject's heart.

[0538] In one application, the valve includes a mitral valve, (1) anchoring a first end of the coiled wire to a first commissure of the valve includes anchoring the first end to an anterior commissure of the valve, (2) allowing the coiled wire to expand along a portion of a circumference of the valve includes allowing the coiled wire to expand along a posterior circumference of the valve, and (3) anchoring a second end of the coiled wire to a second commissure of the valve includes anchoring the second end of the coiled wire to a posterior commissure of the valve.

[0539] In one application, implanting the implant includes implanting the implant around a circumference of the annulus marking device in response to a pressure.

[0540] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

[0541] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

[0542] In one application, viewing the tissue of the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the annulus marking device in response to movement of the tissue.

[0543] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0544] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0545] According to some applications, a method is further provided that includes placing an annulus marking device including a radiopaque material within a native heart valve of a subject's heart, the annulus marking device being shaped to define an expandable element that expands within the heart valve such that the expandable element provides an indication as to the location of a native heart annulus of the subject's native heart valve.

[0546] In some applications, the annulus marking device is compressible during delivery to the native heart valve and expandable from at least a compressed state for positioning within the heart valve. The method can further include expanding the annulus marking device to an expanded state.

[0547] The method may further include implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0548] The method may also include retrieving the annulus marking device after implantation.

[0549] In one application, implanting under imaging includes implanting using fluoroscopy.

[0550] In one application, retrieving the annulus marking device after implantation includes constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

[0551] In one application, the placing includes placing the annulus marking device in a mitral valve, hi one application, the placing includes placing the annulus marking device in a tricuspid valve.

[0552] In one application, expanding the expandable device includes expanding the expandable device to assume a generally spherical shape, and implanting the implant includes positioning the implant between the annulus marking device and tissue of the atrial wall.

[0553] In one application, the expandable element includes a plurality of expandable elements including a mesh of a plurality of woven radiopaque fabric fibers.

[0554] In one application, the expandable element includes a plurality of expandable elements including a mesh of a plurality of woven radiopaque metallic fibers.

[0555] In one application, the expandable element includes a balloon.

[0556] In one application, the method further includes viewing tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device.

[0557] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the expandable element relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the expandable element relative to the tissue.

[0558] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the expandable element relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the expandable element in response to movement of the tissue.

[0559] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the expandable element relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0560] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0561] According to one application of the present invention, there is further provided a system for use with a subject, the system including an implant configured to be positioned along a native heart annulus of a native heart valve of the subject, and an annulus marking device.

[0562] For some applications, the implant includes a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion.

[0563] The annulus marking device can be the same as or similar to any of the annulus marking devices described herein. In some applications, the annulus marking device includes a scaffold including a radiopaque material, the scaffold being collapsible and expandable and configured to laterally press against tissue of the heart valve when expanded. A plurality of radiopaque elements can be coupled to the scaffold, the plurality of radiopaque elements configured to mark the native heart annulus and tissue coupled thereto.

[0564] For one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchor along the body portion. For one application, each of the plurality of radiopaque elements includes a flexible material. For one application, each of the plurality of radiopaque elements includes a radiopaque filament.

[0565] In one application, when the scaffold is expanded, the scaffold is configured to compress tissue of the leaflets of the valve such that the leaflets present two minor leaflets.

[0566] In one application, the annulus marking device is coupled to a delivery tool, and the annulus marking device is retrievable upon removal of the delivery tool from the subject.

[0567] In one application, the scaffold includes at least one rod that has a vertical orientation when the scaffold is expanded, hi one application, the rod extends from an atrial surface of the heart valve toward a ventricular surface of the heart valve when the scaffold is expanded.

[0568] In one application, the plurality of radiopaque elements includes a plurality of radiopaque filaments and the rod is coupled to the plurality of radiopaque filaments such that when the scaffold is expanded, the plurality of radiopaque filaments are configured to be compressed against tissue of the native heart valve annulus and tissue coupled thereto such that the plurality of radiopaque filaments provide indication of the native heart valve annulus and tissue coupled thereto.

[0569] In one application, the at least one rod includes a plurality of rods and the scaffold includes an expandable basket coupled to the plurality of rods, such that the scaffold expands circumferentially relative to the native heart valve such that the plurality of rods are disposed circumferentially relative to the native heart valve.

[0570] In one application, the scaffold includes a central rod, a laterally expandable upper element configured to expand laterally away from the central rod, a laterally expandable lower element configured to expand laterally away from the central rod, and at least one flexible wire coupled to and extending between the laterally expandable upper element and the laterally expandable lower element, wherein the at least one flexible wire is configured to press against tissue of the heart valve when the scaffold is expanded.

[0571] In one application, the laterally expandable upper element and the laterally expandable lower element are longitudinally movable relative to the central rod to control tension in the at least one flexible wire.

[0572] In one application, when the scaffold is expanded, the laterally expandable upper element is configured to be positioned within an atrium of a subject's heart and the laterally expandable lower element is configured to be positioned within a ventricle of the subject's heart.

[0573] In one application example, the laterally expandable upper element includes a first expandable and collapsible ring, the laterally expandable lower element includes a second expandable and collapsible ring, the at least one wire includes at least two wires joined at circumferentially corresponding locations along the first and second rings, and the first and second rings are in an expanded state when the scaffold is expanded.

[0574] In one application example, the laterally expandable upper element includes a first expandable and foldable cross beam extending laterally away from the central rod, the laterally expandable lower element includes a second expandable and foldable cross beam extending laterally away from the central rod, and the at least one wire includes at least two wires joined at corresponding locations along the first and second cross beams, and when the scaffold is expanded, the first and second cross beams are in an expanded state.

[0575] In one application, the scaffold includes a central rod, a first loop element configured to expand laterally away from the central rod, a second loop element configured to expand laterally away from the central rod, at least one curved flexible wire coupled to and extending from the rod within a space defined by at least the first and second loop elements, and a first magnet coupled to an end of the flexible wire, the first magnet being movable by a second magnet not coupled to the scaffold, the first and second loop elements configured to compress tissue of the heart valve when the scaffold is expanded.

[0576] In one application, the first and second loop elements are longitudinally movable relative to the central rod to control tension in the first and second loop elements.

[0577] In one application, a delivery tool is configured to deliver the implant, the system includes a second magnet, and the delivery tool is coupled to the second magnet.

[0578] In one application, when the scaffold is expanded, a first half of each of the first and second loop elements is configured to be positioned within an atrium of the subject's heart and a second half of each of the first and second loop elements is configured to be positioned within a ventricle of the subject's heart.

[0579] For one application, the first and second loop elements include a radiopaque material. hi one application, the first and second loop elements are coupled to a radiopaque material.

[0580] In one application, the scaffold includes a central rod, at least one curved flexible wire coupled to and extending from the rod, and a first magnet coupled to an end of the flexible wire, the first magnetic element being movable by a second magnetic element not coupled to the scaffold.

[0581] In one application example, when the scaffold is expanded, (1) the at least one curved flexible wire is configured to be positioned within a ventricle of a subject's heart, and (2) the first magnetic element is configured to be positioned within the subannular space of the heart.

[0582] In one application, the at least one curved flexible wire is longitudinally movable relative to the central rod.

[0583] In one application, the second magnetic element is configured to be positioned within the vasculature surrounding the native heart valve.

[0584] In one application, the at least one curved flexible wire is coupled to a radiopaque material.In one application, the at least one curved flexible wire includes a radiopaque material.

[0585] In one application example, the scaffold includes a central rod, at least one cross beam coupled to the rod and extending laterally from the rod, and a first magnetic element coupled to an end of the at least one cross beam, the first magnetic element being movable by a second magnetic element not coupled to the scaffold.

[0586] In one application, when the scaffold is expanded, the at least one cross beam is configured to be positioned within an atrium of the subject's heart.

[0587] In one application, the at least one cross beam is longitudinally movable relative to the central rod.

[0588] In one application, the second magnetic element is configured to be positioned within the vasculature surrounding the native heart valve.

[0589] For one application, the at least one cross beam is coupled to a radiopaque material. hi one application, the at least one cross beam includes a radiopaque material.

[0590] According to one application example of the present invention, a system for use with a subject is further provided. The system includes an implant configured to be disposed along the natural heart valve annulus of the subject's natural heart valve, and an annulus marking device that is separated from the implant and removable from within the subject after implantation of the implant. The annulus marking device can be the same as or similar to any annulus marking device described herein.

[0591] In some application examples, the annulus marking device includes a plurality of radiopaque markers juxtaposed with each other at a given distance from each other. Each of the plurality of radiopaque markers is deformable by tissue at different intervals and indicates the proximity of the tissue to the implant.

[0592] In some application examples, the implant includes a body portion including a flexible material. The body portion has a longitudinal axis extending along the length of the body portion.

[0593] In one application example, the plurality of radiopaque markers are of different sizes from each other. In one application example, the plurality of radiopaque markers include concentric loops. In one application example, the plurality of radiopaque markers include concentric petal portions or loops. In one application example, the plurality of radiopaque markers include a plurality of radiopaque strips.

[0594] In one application example, the plurality of radiopaque markers include wires.

[0595] In one application example, each of the plurality of radiopaque markers includes a radiopaque sail portion extending from each radiopaque marker.

[0596] In one application example, each of the plurality of radiopaque markers includes a radiopaque filament extending from each radiopaque marker.

[0597] According to one application of the present invention, there is further provided a system for use with a subject, the system including an implant configured to be positioned along a native heart annulus of a native heart valve of the subject, and an annulus marking device including an elongated radiopaque element and a plurality of flexible radiopaque filaments coupled to the elongated radiopaque element and configured to mark the native heart annulus and tissue coupled thereto.

[0598] For some applications, the elongated radiopaque element is slidable along the body portion and longitudinal axis of the implant, and includes a plurality of radiopaque filaments.

[0599] For some applications, the implant includes a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion.

[0600] In one application, the annulus marking device is removable from the subject after implantation of the implant.

[0601] For one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchor along the body portion. For one application, each of the plurality of radiopaque filaments includes a flexible material. For one application, the elongated radiopaque element includes a wire. For one application, the elongated radiopaque element includes a rod.

[0602] In one application, the plurality of radiopaque filaments are disposed at a distal end of an elongated radiopaque element, and the annulus marking device includes a tube coupled to a proximal end of the elongated radiopaque element, the tube surrounding a body portion and sliding relative to the body portion to move the plurality of radiopaque filaments relative to the implant.

[0603] In one application, a plurality of radiopaque filaments are disposed at a distal end of an elongated radiopaque element, the body portion including a plurality of eyelets, and the elongated radiopaque element is slidable relative to the plurality of eyelets to move the plurality of radiopaque filaments relative to the implant.

[0604] In one application, the plurality of radiopaque filaments are collapsible as they pass through each of the plurality of eyelets.

[0605] According to an application of the present invention, there is further provided a method including placing an annulus marking device including a radiopaque material at a native heart valve annulus of a subject at a first delivery angle relative to a plane of the leaflets of the valve, and implanting an implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging. In some applications, the method further includes retrieving the annulus marking device after implantation.

[0606] The annulus marking device can be the same as or similar to any of the annulus marking devices described herein.

[0607] In some applications, the annulus marking device comprises (1) a radiopaque wire extension and (2) at least one radiopaque curved distal tip disposed at a non-zero angle relative to the wire extension.

[0608] In some applications, the method includes enabling the annulus marking device to move incrementally along the leaflets after placement, and, by moving, changing the delivery angle of the annulus marking device relative to the plane of the leaflets of the valve.

[0609] The method may further include determining a position of the valve annulus by varying the angle and visualizing the change in angle.

[0610] In one application, determining the position includes determining that the curved distal tip is positioned along the valve leaflet in response to visualizing the beating of the annulus marking device.

[0611] In one application, determining the position includes determining that the curved distal tip is positioned at the annulus in response to visualizing that the annulus marking device does not move.

[0612] The method may be performed in a living animal or a simulation, such as a cadaver, a cadaver heart, a simulator (eg, where a body part, tissue, etc. is simulated).

[0613] According to one application of the present invention, there is further provided a system for use with a subject, the system including an implant configured to be positioned along a native heart annulus of a native heart valve of the subject, and an annulus marking device including an expandable radiopaque braided mesh expandable from a collapsed state to an expanded state.

[0614] In some applications, the expanded state includes a frusto-conical shape. In some applications, two or more pull wires are coupled to the expandable braided mesh and configured, when pulled, to cause the braided mesh to transition from a frusto-conical shape to a shape in which the mesh exhibits (1) a sloping top configured to lie within an atrium of a subject's heart, (2) a bulging shelf configured to lie over a heart valve, (3) a narrow portion for lying within a heart valve, and (4) a trumpet-shaped portion configured to expand within a ventricle of the subject's heart.

[0615] For some applications, the implant includes a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion.

[0616] In one application, the annulus marking device is removable from the subject after implantation of the implant.

[0617] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion.

[0618] In one application, the two or more pull wires include three pull wires.

[0619] In one application, the bulging portion has a larger diameter than other portions of the annulus marking device, hi one application, the implant is slidable toward the annulus along the sloped top.

[0620] According to one application of the present invention, there is further provided a system for use with a subject, the system including an implant configured to be positioned along a native heart annulus of a native heart valve of the subject, and an annulus marking device, which may be the same as or similar to other annulus marking devices described herein.

[0621] In some applications, the annulus marking device comprises an expandable radiopaque braided mesh, the mesh expandable from a collapsed state to an expanded state, in which the mesh exhibits (1) a sloping upper portion configured to be positioned within the atrium of the subject's heart and (2) an asymmetric portion to be positioned within the heart valve.

[0622] In one application, the annulus marking device is removable from the subject after implantation of the implant.

[0623] For some applications, the implant includes a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion.

[0624] In one application, the body portion includes a plurality of radiopaque markings configured to indicate placement of the anchors along the body portion.

[0625] In one application, the implant is slidable along the sloped top toward the annulus.

[0626] In one application example, the system includes a stabilization rod and a tissue anchor coupled to an end of the stabilization rod, the tissue anchor configured to be reversibly coupled to tissue of a subject's heart, and a valve annulus marking device slidably coupled to the stabilization rod, the stabilization rod configured to stabilize and guide positioning of the valve annulus marking device.

[0627] In one application, in the expanded state, the mesh exhibits a trumpet-shaped portion configured to expand within a ventricle of the subject's heart.

[0628] In one application, the trumpet-shaped portion has a larger diameter than other portions of the annulus marking device.

[0629] In one application, the system includes a plurality of expandable snare coupled to a distal end of an expandable radiopaque braided mesh, the plurality of expandable radiopaque snare configured to clamp one or more native leaflets of a target native valve.

[0630] For one application, the plurality of expandable snare comprises a rigid material, hi one application, the plurality of expandable snare comprises a flexible material, hi one application, the plurality of expandable snare comprises a radiopaque material.

[0631] In one application, a plurality of expandable snare extend distally from a distal end of the expandable radiopaque braided mesh and then curve proximally.

[0632] In one application, the system includes a plurality of expandable radiopaque elements coupled to a distal end of an expandable radiopaque braided mesh, the plurality of expandable radiopaque elements configured to expand radially, such that the plurality of expandable elements provide an indication of the location of a native heart valve annulus of a subject native heart valve.

[0633] In one application, the plurality of radiopaque expandable elements collectively form the annulus marking device in a generally spherical shape.

[0634] In one application, the plurality of expandable radiopaque elements includes a plurality of woven radiopaque fibers in a mesh form. In one application, the plurality of expandable radiopaque elements includes a plurality of curved wires.

[0635] In one application, the system includes an expandable annular element coupled to a distal end of the expandable radiopaque braided mesh, the expandable annular element configured to position the expandable radiopaque braided mesh within a subject's native valve.

[0636] In one application, the expandable annular element includes a radiopaque material.

[0637] In one application, the expandable annular element includes a prosthetic valve.

[0638] In one application, an expandable radiopaque braided mesh can be positioned within the native heart valve and an inflatable annular element can be positioned beneath the native heart valve.

[0639] According to one application of the present invention, there is further provided a system for use with a subject, the system including an implant configured to be positioned along a native heart annulus of a native heart valve of the subject, and an annulus marking device including a temporary valve.

[0640] In some applications, the temporary valve is an inflatable temporary valve and is inflatable from a collapsed state to an expanded or enlarged state. In some applications, in the expanded state, the inflatable temporary valve includes (1) a non-compliant proximal balloon configured to be positioned within the native heart valve and partially within the atrium of the subject's heart, and (2) a compliant distal balloon configured to be positioned within the sub-annular space of the native heart valve.

[0641] In one application, two or more prosthetic leaflets are coupled to a temporary valve.

[0642] For some applications, the implant includes a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion.

[0643] According to one application example of the present invention, there is further provided a method comprising: delivering a valve annulus marking device including at least a first magnetic element to one or more surfaces of a native heart valve of a subject's heart, the one or more surfaces being selected from the group consisting of an atrial surface and a ventricular surface; delivering a second magnetic element to a vascular structure surrounding the heart valve; generating a magnetic field around the at least the first magnetic element; and implanting an implant along the subject's native heart valve annulus using the valve annulus marking device as a guide for implanting the implant along the annulus under imaging.

[0644] In some applications, the method further includes retrieving the annulus marking device after implantation.

[0645] In one application, at least a first magnetic element is coupled to the curved wire, and delivering the annulus marking device includes delivering the first magnetic element to the ventricular surface.

[0646] In one application, at least a first magnetic element is coupled to an end of the at least one cross beam, and delivering the annulus marking device includes delivering the first magnetic element to the atrial surface.

[0647] In one application, generating the magnetic field includes positioning a magnetic element in a suitable location relative to the tissue of the valve.

[0648] In one application, implanting under imaging includes implanting using fluoroscopy.

[0649] In one application, delivering the annulus marking device includes delivering the annulus marking device to a mitral valve.In one application, delivering the annulus marking device includes delivering the annulus marking device to a tricuspid valve.

[0650] In one application, the method further includes viewing tissue of the native heart valve annulus and tissue associated therewith using at least a first magnetic element.

[0651] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing a first magnetic element relative to the tissue.

[0652] In one application, viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of the atrial wall.

[0653] These and other methods herein may be performed in a living animal or simulation, such as a cadaver, a cadaver heart, a simulator (eg, in which body parts, tissues, etc. are simulated).

[0654] The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken in conjunction with the drawings. [Brief description of the drawings]

[0655] [Figure 1A] 1A-1D are schematic diagrams of example respective annulus marking devices for assisting in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 1B] 1A-1D are schematic diagrams of example respective annulus marking devices for assisting in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 1C]1A-1D are schematic diagrams of example respective annulus marking devices for assisting in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 2A] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 2B] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 2C] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 2D] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 2E] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 2F] 1A-1C are schematic diagrams of methods of implanting the annulus marking device of FIGS. 1A-1C, according to some applications. [Figure 3A] 1A-1D are schematic diagrams of example annulus marking devices according to several application examples. [Figure 3B] 1A-1D are schematic diagrams of example annulus marking devices according to several application examples. [Figure 3C] 1A-1D are schematic diagrams of example annulus marking devices according to several application examples. [Figure 4A] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 4B] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 5A] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 5B] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 6A]1A-1C are schematic diagrams of respective tissue anchors with annulus marking devices, according to some applications. [Figure 6B] 1A-1C are schematic diagrams of respective tissue anchors with annulus marking devices, according to some applications. [Figure 7A] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 7B] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 7C] 1 is a schematic diagram of an implant with an annulus marking device, according to some applications. [Figure 8A] 1 is a schematic diagram of an annulus marking device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 8B] 1 is a schematic diagram of an annulus marking device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 9A] FIG. 1 is a schematic diagram of a navigation-based guiding system that utilizes one or more longitudinal guides configured to contact a surface of the mitral valve to facilitate guiding an implant to a specific portion of the mitral valve, according to some applications. [Figure 9B] FIG. 1 is a schematic diagram of a navigation-based guiding system that utilizes one or more longitudinal guides configured to contact a surface of the mitral valve to facilitate guiding an implant to a specific portion of the mitral valve, according to some applications. [Figure 10A] 1 is a schematic diagram of an annulus marking device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 10B] 1 is a schematic diagram of an annulus marking device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 11A]1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 11B] 1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 11C] 1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 12A] 1 is a schematic diagram of a system for facilitating imaging of cardiac tissue during implantation of a cardiac implant, comprising a mapping catheter, according to some applications. [Figure 12B] 1 is a schematic diagram of a system for facilitating imaging of cardiac tissue during implantation of a cardiac implant, comprising a mapping catheter, according to some applications. [Figure 13] 1 is a schematic diagram of a valve annulus marking device comprising a generally spherical expandable element for facilitating imaging of cardiac tissue during implantation of a cardiac implant, according to some applications. [Figure 14] 1 is a schematic diagram of a valve annulus marking device comprising a generally spherical expandable mesh for facilitating imaging of cardiac tissue during implantation of a cardiac implant, according to some applications. [Figure 15] 1 is a schematic diagram of a system including an annulus marking device with a guidewire extending along an implant to assist in implantation of the implant under imaging guidance, according to some applications. [Figure 16A] 1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 16B] 1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 16C] 1A-1C are schematic diagrams of respective annulus marking devices for assisting implantation of cardiac devices under imaging guidance, according to some applications. [Figure 17A] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 17B] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 17C] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 18] 1 is a schematic diagram of an annulus marking device for use within a ventricle to assist in the implantation of a cardiac device under imaging guidance, in accordance with some applications. [Figure 19A] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 19B] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 19C] 1A-1C are schematic diagrams of respective annulus marking devices with expandable elements to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 20A] 1 is a schematic diagram of an annulus marking device comprising an annular stent to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 20B] 1 is a schematic diagram of an annulus marking device comprising an annular stent to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 21] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 22]1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 23] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 24] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 25] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 26] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 27] 1A-1C are schematic diagrams of respective annulus marking devices with an implant guidance device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 28A] 1 is a schematic diagram of an annulus marking device comprising multiple implantable radiopaque pins to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 28B] 1 is a schematic diagram of an annulus marking device comprising multiple implantable radiopaque pins to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 29] FIG. 1 is a schematic diagram of an annulus marking device with multiple radiopaque pins that move proximally and distally to assist in implantation of cardiac devices under imaging guidance, according to some applications. [Figure 30A]1A-1C are schematic diagrams of respective annulus marking devices each comprising multiple radiopaque filaments deliverable through a multi-lumen tube to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 30B] 1A-1C are schematic diagrams of respective annulus marking devices each comprising multiple radiopaque filaments deliverable through a multi-lumen tube to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 31] 1A-1C are schematic diagrams of respective annulus marking devices each comprising multiple radiopaque filaments deliverable through a multi-lumen tube to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 32] 1 is a schematic diagram of an annulus marking device with an expandable element to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 33A] 1 is a schematic diagram of an annulus marking device with an expandable element to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 33B] 1 is a schematic diagram of an annulus marking device with an expandable element to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 34A] 1 is a schematic diagram of a valve annulus marking device with concentric wire loops to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 34B] 1 is a schematic diagram of a valve annulus marking device with concentric wire loops to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 34C] 1 is a schematic diagram of a valve annulus marking device with concentric wire loops to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Diagram 35] 1 is a schematic diagram of a multiple petal annulus marking device for assisting in the implantation of cardiac devices under imaging guidance, according to some applications. [Diagram 36] 1 is a schematic diagram of a valve annulus marking device comprising multiple radiopaque filaments coupled to a distal end of a guidewire, according to some applications. [Figure 37A] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37B] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37C] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37D] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37E] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37F] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 37G] 1 is a schematic diagram of an annulus marking device comprising first and second radiopaque loops for assisting in implantation of a cardiac device under imaging guidance, according to some applications. FIG. [Figure 38] 1 is a schematic diagram of an annulus marking device comprising two or more expandable wires and an ultrasound transducer to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 39]1 is a schematic diagram of an annulus marking device with clips to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 40] 1 is a schematic diagram of an annulus marking device with a clamp to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 41] 1 is a schematic diagram of an annulus marking device comprising a balloon having upper and lower inflatable sections to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 42] 1 is a schematic diagram of an annulus marking device with a balloon to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Diagram 43] 13 is a schematic diagram of an annulus marking device comprising a balloon having upper and lower inflatable sections for assisting in the implantation of a cardiac device under imaging guidance, according to some other applications. [Diagram 44] 1A-1D are schematic diagrams of an annulus marking device with magnetic elements to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Diagram 45] 1A-1D are schematic diagrams of an annulus marking device with magnetic elements to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 46] 1A-1D are schematic diagrams of an annulus marking device with magnetic elements to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 47] 1 is a schematic diagram of a spring-equipped annulus marking device for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 48] 1 is a schematic diagram of an annulus marking device with an expandable element to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 49A] 1A-1C are schematic diagrams of an annulus marking device with a scaffold to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 49B] 1A-1C are schematic diagrams of an annulus marking device with a scaffold to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 50A] 1A-1C are schematic diagrams of an annulus marking device comprising a scaffold comprising rods to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 50B] 1A-1C are schematic diagrams of an annulus marking device comprising a scaffold comprising rods to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 51A] 1A-1C are schematic diagrams of an annulus marking device comprising a scaffold with an expandable basket to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 51B] 1A-1C are schematic diagrams of an annulus marking device comprising a scaffold with an expandable basket to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 51C] 1A-1C are schematic diagrams of an annulus marking device comprising a scaffold with an expandable basket to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 52A] 1 is a schematic diagram of a valve annulus marking device comprising multiple radiopaque markers to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 52B] 1 is a schematic diagram of a valve annulus marking device comprising multiple radiopaque markers to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 53A] 1 is a schematic diagram of an annulus marking device coupled to an implant for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 53B] 1 is a schematic diagram of an annulus marking device coupled to an implant for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 54A]1 is a schematic diagram of an annulus marking device coupled to an implant for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 54B] 1 is a schematic diagram of an annulus marking device coupled to an implant for assisting implantation of a cardiac device under imaging guidance, according to some applications. [Figure 55A] 1 is a schematic diagram of an annulus marking device with a radiopaque guide to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 55B] 1 is a schematic diagram of an annulus marking device with a radiopaque guide to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 55C] 1 is a schematic diagram of an annulus marking device with a radiopaque guide to assist in implantation of a cardiac device under imaging guidance, according to some applications. [Figure 56A] 1A-1C are schematic diagrams of an annulus marking device comprising a radiopaque expandable mesh to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 56B] 1A-1C are schematic diagrams of an annulus marking device comprising a radiopaque expandable mesh to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 56C] 1A-1C are schematic diagrams of an annulus marking device comprising a radiopaque expandable mesh to assist in the implantation of cardiac devices under imaging guidance, according to some applications. [Figure 57A] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 57B] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 58A]1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 58B] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 59A] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 59B] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 60A] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 60B] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 61A] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 61B] 1A-1C are schematic diagrams of respective annulus marking devices comprising a radiopaque asymmetric mesh to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 62A] 1 is a schematic diagram of an annulus marking device with an inflatable prosthetic valve to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 62B]1 is a schematic diagram of an annulus marking device with an inflatable prosthetic valve to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 63A] 1A-1C are schematic diagrams of an annulus marking device with a scaffold and a magnet to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 63B] 1A-1C are schematic diagrams of an annulus marking device with a scaffold and a magnet to assist in the implantation of a cardiac device under imaging guidance, according to some applications. [Figure 64] 1A-1D are schematic diagrams of an annulus marking device with magnetic elements to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. [Figure 65] 1A-1D are schematic diagrams of an annulus marking device with magnetic elements to assist in the implantation of cardiac devices under imaging guidance, according to respective application examples. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0656] 1A-1C, which are schematic illustrations of respective annulus marking devices for assisting implantation of a cardiac device under imaging guidance, in accordance with some applications of the present invention. The steering procedure can be performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0657] FIG. 1A shows a system 20 including an annulus marking device 22 including a radiopaque material, shaped to define a foundation frame 24 having a shape that follows the circumference of the native heart valve annulus to approximate the shape of the annulus. That is, the frame 24 has a circular shape that follows the circumference of the native heart valve. The device 22 includes one or more struts 26 (e.g., three, as shown by way of example and not limitation). The struts 26 project away from the plane defined by the foundation frame 24 and are shaped to be positioned within the commissures of the native valve. The struts 26 thereby provide an indication of the location, height, and orientation of the commissures under imaging. The struts 26 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the foundation frame 24 against movement within the annulus. The struts 26 are spaced apart to remain engaged with tissue at or near the leaflet commissures (or are intended to remain engaged wherever tissue contacts the struts 26). For some applications, the frame 24 and struts 26 are fabricated from a single piece. Optionally, the frame 24 and struts 26 can be fabricated as separate parts and coupled together, e.g., by welding, fastening, etc. The struts 26 can provide an indication as to the height of the valve annulus, such that the height of the annulus can be measured when placing the device 22, e.g., by imaging the struts when contacting the annulus.

[0658] The device 22 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. To aid in percutaneous delivery and / or for other reasons, the device 22 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables the device 22 to fold and collapse, so that the device 22 can be delivered within a catheter, which can then self-expand to the desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 22 comprises a wire.

[0659] The device 22 is configured to be positioned along the native tricuspid valve. Thus, the frame 24 of the device 22 is generally circular. For some applications, the device 22 includes an adjustment mechanism 28 that expands and contracts the circumference of the foundation frame 24. For some applications, the foundation frame 24 is hollow and shaped to define a lumen, and the adjustment mechanism 28 includes a wire that passes at least partially through the lumen of the foundation frame 24. In such applications, the wire can be pulled and / or twisted to adjust the circumference of the foundation frame 24. For some applications, a portion of the foundation frame 24 is telescopically foldable in response to the wire of the adjustment mechanism 28 being pulled.

[0660] The device 22 is compressible during delivery to the native heart valve. During delivery of the device 22, the device 22 is constrained in a collapsed state. A flexible push rod can be used to expel the device 22 from the delivery catheter. Upon release from the catheter, the device 22 self-expands from its compressed state to a predetermined configuration, for example as shown in FIG. 1A.

[0661] FIG. 1B illustrates a system 30 including an annulus marking device 32 that includes a radiopaque material and is shaped to follow the circumference of the native heart valve annulus to define a foundation frame 34 having a shape that approximates the shape of the annulus. That is, the frame 34 has a "D" shape that follows the circumference of the native heart valve. The device 32 includes one or more struts 36 (e.g., three, as shown by way of example and not limitation). The struts 36 project away from the plane defined by the foundation frame 34 and are shaped to be positioned within the commissures of the native valve. The struts 36 thereby provide an indication of the location, height, and orientation of the commissures under imaging. The struts 36 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the foundation frame 34 against movement within the annulus. The struts 36 are spaced to remain engaged with tissue at or near the leaflet commissures (or are intended to remain engaged wherever tissue contacts the struts 36). For some applications, the frame 34 and struts 36 are fabricated from a single piece, or as separate components that are joined together, as described above with respect to device 22. Also, as described above, the struts 36 can provide an indication of the height of the valve annulus, such that the height of the annulus can be measured when deploying device 32, for example by imaging the struts when contacting the annulus.

[0662] The device 32 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. When delivered percutaneously, the device 32 can be made of a superelastic material (e.g., Nitinol or stainless steel) that enables the device 32 to fold and collapse, so that the device 32 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 32 comprises a wire.

[0663] The device 32 is configured to be placed along the native mitral valve. Thus, the frame 34 of the device 32 is substantially D-shaped, and the struts 36 are spaced apart at opposite positions to fit within the commissures of the native mitral valve. For some applications, the frame 34 of the device 32 is substantially saddle-shaped, and thus the frame 34 looks like a wavy perimeter of a saddle. For some applications, the device 32 includes an adjustment mechanism 38 that expands and contracts the circumference of the foundation frame 34. For some applications, the foundation frame 34 is hollow and shaped to define a lumen, and the adjustment mechanism 38 includes a wire that passes at least partially through the lumen of the foundation frame 34. In such applications, the wire can be pulled and / or twisted to adjust the circumference of the foundation frame 34. For some applications, a portion of the foundation frame 34 is telescopically foldable in response to the wire of the adjustment mechanism 38 being pulled.

[0664] The device 32 is compressible during delivery to the native heart valve. During delivery of the device 32, the device 32 is constrained in a collapsed state. A flexible push rod can be used to expel the device 32 from the delivery catheter. Upon release from the catheter, the device 32 self-expands from its compressed state to a predetermined configuration, for example as shown in FIG. 1B.

[0665] FIG. 1C illustrates a system 40 including an annulus marking device 42 that includes a radiopaque material and is shaped to define a foundation frame 44 that follows the circumference of the native heart valve annulus and has a shape that approximates the shape of the annulus. That is, the frame 44 has a circular shape that follows the circumference of the native heart valve. The device 42 includes one or more struts 46 (e.g., three, as shown by way of example and not limitation). The struts 46 project away from the plane defined by the foundation frame 44 and are shaped to be positioned within the commissures of the native valve. The struts 46 thereby provide an indication of the location, height, and orientation of the commissures under imaging. The struts 46 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the foundation frame 44 against movement within the annulus. The struts 46 are spaced to remain engaged with tissue at or near the leaflet commissures (or are intended to remain engaged wherever tissue contacts the struts 46). For some applications, the frame 44 and struts 46 are fabricated from a single piece, or as separate components that are joined together as described above with respect to device 22. The struts 46 can also provide an indication as to the height of the valve annulus, such that the height of the annulus can be measured when placing the device 42, for example by imaging the struts when contacting the annulus.

[0666] The device 42 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgical techniques. The device 42 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables bending and collapsing of the device 42, so that the device 42 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 42 comprises a wire.

[0667] The device 42 is configured to be positioned along the native mitral valve. As shown, the frame 44 of the device 42 is generally circular, and the struts 46 are spaced apart at opposite positions to fit within the commissures of the native mitral valve. For some applications, the frame 44 of the device 42 is substantially saddle-shaped. For some applications, the device 42 includes an adjustment mechanism 48 that expands and contracts the circumference of the foundation frame 44. For some applications, the foundation frame 44 is hollow and shaped to define a lumen, and the adjustment mechanism 48 includes wires that run at least partially through the lumen of the foundation frame 44. In such applications, the wires can be pulled and / or twisted to adjust the circumference of the foundation frame 44. For some applications, a portion of the foundation frame 44 is telescopically foldable in response to the wires of the adjustment mechanism 48 being pulled.

[0668] The device 42 is compressible during delivery to the native heart valve. During delivery of the device 42, the device 42 is constrained in a collapsed state. A flexible push rod can be used to expel the device 42 from the delivery catheter. Upon release from the catheter, the device 42 self-expands from its compressed state to a predetermined configuration, for example as shown in FIG. 1C.

[0669] 1A-1C, devices 22, 32, and 42 are made, for example by machining, bending, forming, bonding, molding, or extrusion, from biocompatible metallic or polymeric materials, or metallic or polymeric materials suitably coated, impregnated, or otherwise treated with materials that impart biocompatibility, or combinations of such materials. The materials are also desirably radiopaque to facilitate visualization by fluoroscopy.

[0670] Reference is now made to FIGS. 2A-2F, which are schematic illustrations of a method and system 60 for implanting the annulus marking device of FIGS. 1A-1C, according to certain applications.

[0671] 2A, device 22 is positioned along annulus 66 of native tricuspid valve 62, and device 32 is positioned along annulus 68 of native mitral valve 64. Note that device 42 may be implanted along mitral valve 64. As discussed above, devices 22 and 32 may be delivered into the atrium in a constrained configuration and then expanded within the atrium. Percutaneous vascular access may be achieved, for example, by conventional methods into the femoral or jugular vein.

[0672] 2B, devices 22 and 32 are adjusted by respective adjustment mechanisms 28 and 38. In some applications, an adjustment tool 70 engages a portion of adjustment mechanisms 28 and 38 and pulls and / or twists that portion of adjustment mechanisms 28 and 38 (e.g., the wires of mechanisms 28 and 38). Frames 24 and 34 are adjusted by tool 70 to achieve the desired positioning of devices 22 and 32, respectively, along the annulus.

[0673] In FIG. 2C, an implant, for example annuloplasty structure 72, is positioned along the annulus 66 of the tricuspid valve 62 using a delivery tool 74 that passes through the structure 72 into the right atrium via the superior or inferior vena cava. The structure 72 can include a flexible body portion. For some applications, the body portion of the structure 72 is shaped to define a tubular sleeve through which the anchors are implanted. The body portion of the structure 72 includes a plurality of radiopaque markers 75 that are positioned at respective longitudinal locations along the structure 72. The markers provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during the implantation procedure to effect setting a desired distance between tissue anchors along the body portion. For some applications, the markers include radiopaque ink. For some applications, the markers include markers of radiopaque material or additional radiopaque material, such as those attached to or incorporated within the structure 72 .

[0674] The structure 72 is delivered within a delivery tool 74. The delivery tool 74 is guided and steered according to imaging guided by the annulus marking device 22. That is, the structure 72 is positioned along and anchored to the annulus 66 under imaging using the annulus marking device 22 to mark the annulus and commissure tissue.

[0675] In some applications, at least a portion (e.g., at least three, some, all, etc.) of the longitudinal portions of the radiopaque markers 75 are longitudinally spaced apart at regular intervals. In some applications, the longitudinal distance between the distal edges of adjacent markers and / or the distance between the proximal edges of adjacent markers is set equal to a desired distance between adjacent anchors. For example, the markers can comprise a first, second, and third marker, where the first and second markers are adjacent and the second and third markers are adjacent, and where the distance between the proximal and / or distal edges of the first and second markers is equal to the corresponding distance between the proximal and / or distal edges of the second and third markers. For example, the distance may be 3 to 15 mm, such as 6 mm, and the longitudinal length of each marker may be 0.1 to 14 mm, such as 2 mm (for example, if the distance is 6 mm and the length is 2 mm, the longitudinal gap between adjacent markers should have a length of 4 mm).

[0676] The annuloplasty structure 72 is used to repair a dilated annulus of the tricuspid valve 62. For some applications, the annuloplasty structure is configured to be only partially disposed around the annulus (e.g., assuming a C-shape) and, after being anchored in place, to contract to circumferentially tighten the annulus.

[0677] For some applications, the structure 72 further comprises an adjustment mechanism that facilitates contraction and expansion of the annuloplasty structure 72 to facilitate adjustment around the annulus and leaflets of the heart valve. For some applications, the adjustment mechanism comprises a contraction member, such as a wire, line, suture, elongated member, etc., extending along the annuloplasty structure 72, and a rotatable structure (e.g., a spool, wheel, spindle, etc.) configured to apply a contraction force to the contraction member to longitudinally contract the annuloplasty structure 72.

[0678] In FIG. 2D, an implant, for example an annuloplasty structure 76, is positioned along the annulus 68 of the mitral valve 64 using a delivery tool 74 that passes through the structure 76 into the left atrium via the superior or inferior vena cava and then through the fossa ovalis. In some applications, the structure 76 comprises a flexible body portion. For some applications, the body portion of the structure 76 is shaped to define a tubular sleeve through which the anchors are implanted. The body portion of the structure 76 comprises a plurality of radiopaque markers 75, which are positioned at respective longitudinal locations along the structure 76. The markers provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during the implantation procedure to effect setting a desired distance between tissue anchors along the body portion. For some applications, the markers include radiopaque ink. For some applications, the markers include markers of radiopaque material or additional radiopaque material, such as those attached to or incorporated within the structure 76 .

[0679] The structure 76 is delivered within a delivery tool 78. The delivery tool 78 is guided and steered according to imaging guided by the annulus marking device 32. That is, the structure 76 is positioned along and anchored to the annulus 68 under imaging using the annulus marking device 32 to mark the annulus and commissure tissue.

[0680] For some applications, at least a portion (e.g., at least three, such as all) of the longitudinal portions of the radiopaque markers 75 are longitudinally spaced apart at regular intervals. For some applications, the longitudinal distance between the distal edges of adjacent markers and / or the distance between the proximal edges of adjacent markers is set equal to a desired distance between adjacent anchors. For example, the markers may comprise a first, second, and third marker, where the first and second markers are adjacent and the second and third markers are adjacent, and where the distance between the proximal and / or distal edges of the first and second markers is equal to the corresponding distance between the proximal and / or distal edges of the second and third markers. For example, the distance may be 3 to 15 mm, such as 6 mm, and the longitudinal length of each marker may be 0.1 to 14 mm, such as 2 mm (for example, if the distance is 6 mm and the length is 2 mm, the longitudinal gap between adjacent markers should have a length of 4 mm).

[0681] The annuloplasty structure 76 is used to repair a dilated annulus of the mitral valve 64. For some applications, the annuloplasty structure is configured to be only partially disposed around the annulus (e.g., assuming a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. For certain applications, the annuloplasty structure 76 is implemented using techniques described in U.S. Patent Application No. 12 / 437,103, filed May 7, 2009, published as U.S. Patent Application Publication No. 2010 / 0286767, and / or U.S. Patent Application No. 12 / 689,635, filed January 19, 2010, published as U.S. Patent Application Publication No. 2010 / 0280604, both of which are assigned to the assignee of the present application and are incorporated herein by reference.

[0682] For some applications, the structure 76 further comprises an adjustment mechanism that facilitates contraction and expansion of the annuloplasty structure 76 to facilitate adjustment around the annulus and leaflets of the heart valve. For some applications, the adjustment mechanism comprises a contraction member, such as a wire, line, suture, elongated member, etc., extending along the annuloplasty structure 76, and a rotatable structure (e.g., a spool, wheel, spindle, etc.) configured to apply a contraction force to the contraction member to longitudinally contract the annuloplasty structure 76.

[0683] 2E illustrates retrieval of the annulus marking device 22 following implantation of the annuloplasty structure 72 in the annulus 66 of the tricuspid valve 62. Because the device 22 is flexible and compressible, the device 22 is constrained by pulling the device 22 within an extraction tool 80 during retrieval and subsequent removal of the device 22 from the subject's body. That is, with such embodiments, the device 22 does not function as an implant and is used only to guide the implantation of the annuloplasty structure 72 (i.e., the implant); rather, the device 22 acts as a guide for implantation when temporarily positioned within the patient's body and is then removed from the body following implantation of the annuloplasty structure 72.

[0684] 2F illustrates retrieval of the annulus marking device 32 after implantation of the annuloplasty structure 76 at the annulus 68 of the mitral valve 64. Because the device 32 is flexible and compressible, the device 32 is constrained by pulling the device 32 within an extraction tool 80 during retrieval and subsequent removal of the device 32 from the subject's body. That is, with such embodiments, the device 32 does not function as an implant and is used only to guide the implantation of the annuloplasty structure 76 (i.e., the implant); rather, the device 32 acts as a guide for implantation when temporarily positioned within the patient's body and is then removed from the body following implantation of the annuloplasty structure 76.

[0685] 1A-1C and 2A-2F. It should be noted that the annulus marking devices 22, 32, and 42 can be used as rails to mechanically guide the implantation of the annuloplasty structures described herein. When the annuloplasty structure 76 is implanted along the annulus, the frame of the annulus marking devices 22, 32, and 42, which can press the structure 76 against the annulus as the anchor is implanted into the annulus and is therefore less flexible than the annulus tissue, can provide tactile feedback to the surgeon and also act as a rail against which the structure 76 flexes against the more flexible annulus tissue. That is, the delivery tool that delivers the annuloplasty structure uses the frame of the devices 22, 32, and 42 as a tactile and mechanical guide in addition to being a visual guide for moving the delivery tool along the annulus.

[0686] 3A-3C, which are schematic illustrations of respective annulus marking devices 92 and 102 similar to devices 22 and 32 of FIGS. 1A-1B, respectively, but each of devices 92 and 102 includes a plurality of radiopaque elements 99 (e.g., radiopaque markers, filaments, wires, extensions, beads, etc.), which are described herein, for example, but not limited to, as radiopaque filaments 99. The plurality of radiopaque filaments 99 function as additional annulus marking devices. According to some applications, annulus marking devices 92 and 102 are configured to assist in implantation of cardiac devices under imaging guidance. Navigation procedures are often performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0687] FIG. 3A illustrates a system 90 comprising an annulus marking device 92 comprising a radiopaque material shaped to follow the circumference of a native heart valve annulus to define a foundation frame 94 having a shape that approximates the shape of the annulus. The device 92 comprises one or more struts 96 (e.g., three, as shown by way of example and not limitation). The struts 96 project away from a plane defined by the foundation frame 94 and are shaped to be positioned within the commissures of the native valve. The struts 96 thereby provide an indication of the location, height, and orientation of the commissures under imaging. The struts 96 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the foundation frame 94 against movement within the annulus. The struts 96 are spaced apart to remain engaged with tissue at or near the leaflet commissures (or are intended to remain engaged wherever tissue contacts the struts 96). For some applications, the frame 94 and the struts 96 are fabricated from a single piece or as separate components that are joined together as described above with respect to device 22. The struts 96 can also provide an indication of the height of the valve annulus, such that the height of the annulus can be measured when placing the device 92, for example by imaging the struts when in contact with the annulus.

[0688] The device 92 can be delivered percutaneously, thoracoscopically through the chest, and / or using open heart surgical techniques. The device 92 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables bending and collapsing of the device 92, so that the device 92 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 92 comprises a wire.

[0689] The device 92 is configured to be positioned along the native tricuspid valve. Thus, the frame 94 of the device 92 is generally circular. For some applications, the device 92 includes an adjustment mechanism 98 that expands and contracts the circumference of the foundation frame 94. For some applications, the foundation frame 94 is hollow and shaped to define a lumen, and the adjustment mechanism 98 includes a wire that passes at least partially through the lumen of the foundation frame 94. In such applications, the wire can be pulled and / or twisted to adjust the circumference of the foundation frame 94. For some applications, a portion of the foundation frame 94 is telescopically foldable in response to the wire of the adjustment mechanism 98 being pulled.

[0690] The device 92 is compressible during delivery to the native heart valve. During delivery of the device 92, the device 92 is constrained in a collapsed state. A flexible push rod can be used to expel the device 92 from the delivery catheter. Upon release from the catheter, the device 92 self-expands from its compressed state to a predetermined configuration, for example as shown in FIG. 3A.

[0691] 3B illustrates a system 100 that includes an annulus marking device 102 that includes a radiopaque material and is shaped to define a foundation frame 104 that follows the circumference of a native heart annulus and has a shape that approximates the shape of the annulus. The device 102 includes one or more struts 106 (e.g., three, as shown by way of example and not limitation). The struts 106 project away from a plane defined by the foundation frame 104 and are shaped to be positioned within the commissures of the native valve. The struts 106 thereby provide an indication of the location, height, and orientation of the commissures under imaging. The struts 106 are desirably sized and configured to contact tissue near or within the heart annulus to support the foundation frame 104 against movement within the annulus. The struts 106 are spaced to remain engaged with tissue at or near the leaflet commissures (or are intended to remain engaged wherever tissue contacts the struts 106). For some applications, the frame 104 and struts 106 are fabricated from a single piece, or as separate components that are joined together, as described above with respect to device 22. The struts 106 can also provide an indication of the height of the valve annulus, such that the height of the annulus can be measured when placing the device 102, for example by imaging the struts when contacting the annulus.

[0692] The device 102 can be delivered percutaneously, thoracoscopically through the chest, and / or using open heart surgical techniques. The device 102 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables bending and collapsing of the device 102, so that the device 102 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 102 comprises a wire.

[0693] Device 102 is configured to be disposed along a native mitral valve. Accordingly, the frame 104 of device 102 is substantially D-shaped, and the struts 106 are spaced apart at opposite positions to fit within the commissures of the native mitral valve. In some applications, the frame 104 of device 102 is substantially saddle-shaped. In some applications, device 102 includes an adjustment mechanism 108 that expands and contracts around a base frame 104. In some applications, the base frame 104 is hollow and shaped to define a lumen, and the adjustment mechanism 108 includes a wire that at least partially passes through the lumen of the base frame 104. In such applications, the wire can be pulled and / or twisted to adjust around the base frame 104. In some applications, a portion of the base frame 104 is telescopically collapsible in response to the wire of the adjustment mechanism 108 being pulled.

[0694] Device 102 is compressible during delivery to a native heart valve. During delivery of device 102, device 102 is constrained in a folded state. A flexible pushrod can be used to eject device 102 from a delivery catheter. When released from the catheter, device 102 self-expands from its compressed state to a predetermined configuration, as shown, for example, in FIG. 3B.

[0695] The frame 104 of device 102 can be circular or another shape.

[0696] Referring now to FIGS. 3A-3C, a plurality of radiopaque filaments 99 can be configured to include a radiopaque material (e.g., nitinol or stainless steel) and have extremely high flexibility. The filaments 99 project radially away from the base frames 94 and 104.

[0697] For some applications, the filament 99 wobbles with the movement of blood. For some applications, the filament 99 compresses the tissue of the valve annulus and tissue connected thereto (shown in FIG. 3C), such as tissue of the atrial wall 122 and tissue of the leaflets of the native valve. Throughout this disclosure, the term "compression" has the same or similar meaning as the terms "pressing," "positioning," or "aligning," regardless of the strength of the force applied. Thus, the filament 99 provides enhanced imaging of the tissue of the valve 64. That is, when the filament 99 appears bent or compressed, the imaging detects the valve annulus tissue, and when the filament 99 is straight, this can indicate the opening of the valve. FIG. 3C shows the system 120 with the device 102 positioned within the native mitral valve 64. The frame 104 is positioned along the valve annulus 68, with the struts 106 positioned at the commissures 65 and 67, respectively. As described above, the struts 106 provide an indication of the height of the valve annulus of the valve 64. While the device 102 is in position, the native valve 64 functions normally.

[0698] 4A-4B, which are schematic illustrations of a system 140 including an implant including an annuloplasty structure 142 including a body portion 144 and an annulus marking device including a plurality of radiopaque protrusions distributed along and attached to the body portion 144 and shaped to define a plurality of tubular elements 148, according to some applications. The body portion 144 includes a flexible material, such as a braided fabric mesh. For some applications, the body portion 144 is shaped to define a sleeve shaped to define a lumen through the body portion 144, as shown. For some applications, the body portion 144 is flat. The body portion 144 extends along a central longitudinal axis 141 of the structure 142, and the radiopaque protrusions including the tubular elements 148 protrude away from the longitudinal axis 141.

[0699] The body portion 144 may comprise a braided fabric mesh, for example, DACRON™. The body portion 144 may be configured to be only partially disposed around the heart valve annulus (e.g., exhibiting a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the structure 142 may be configured to be entirely disposed around the annulus (e.g., as a closed circle or other closed shape). To tighten the annulus, the annuloplasty structure 142 comprises a flexible, elongated contraction member 145 extending along the body portion 144. The elongated contraction member 145 comprises a wire, ribbon, rope, or band, and often comprises a flexible and / or superelastic material, such as Nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 145 comprises a radiopaque material. For some applications, the contraction member 145 comprises a braided polyester suture (e.g., Ticron). For some applications, the contractile member 145 is coated with polytetrafluoroethylene (PTFE). For some applications, the contractile member 145 comprises multiple wires twisted together to form a rope structure.

[0700] The plurality of radiopaque projections include tubular elements 148 that include a flexible fabric. In some applications, tubular elements 148 and body portion 144 include the same material. Tubular elements 148 may be tapered away from axis 141, as shown. As shown, the distal end of each element 148 (i.e., the end of element 148 furthest from body portion 144) is closed, such that elements 148 are in the shape of a pocket. For some applications, elements 148 are each shaped to define a windsock.

[0701] Body portion 144 of structure 142 includes a plurality of radiopaque markers 146 positioned at respective longitudinal locations along structure 142. The markers facilitate setting a desired distance between tissue anchors 147 along body portion 144, and thus can provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during an implantation procedure to indicate placement of anchors 147. For some applications, the markers include radiopaque ink. For some applications, the markers include a radiopaque material attached to or incorporated within body portion 144.

[0702] As shown, the contraction member 145 is coupled to the body portion 144 and extends along the body portion 144 through the plurality of tubular elements 148 such that during application of tension to the contraction member 145, the contraction member 145 is configured to change the structural configuration of the plurality of radiopaque protrusions comprising the tubular elements 148. As shown in FIG. 4B, the contraction member 145 is configured to change the structural configuration of the elements 148 by closing the openings 149 of each of the tubular elements 148 (openings 149 are shown in FIG. 4A). In such an embodiment, as shown, the contraction member 145 extends along the circumference of each opening 149 of each tubular element 148. For some applications, the contraction member 145 extends along the circumference of each tubular element 148 such that during application of tension to the contraction member 145, the member 145 is configured to radially compress each tubular element 148 toward the axis 141 of the structure 142. For some applications, the constriction members are configured to sequentially change the spatial configuration of the tubular elements 148 .

[0703] For some applications, the constriction member 145 is configured to further apply a constriction force to the body portion 144 of the structure 142 to facilitate adjustment of the circumference of the annuloplasty structure 142. Adjustment of the annuloplasty structure 142 may be performed, for example, by an adjustment mechanism similar to that described above with respect to the annuloplasty structure 72. For some applications, the system 140 includes an additional constriction member (not shown) configured to adjust the circumference of the body portion 144 as the constriction member 145 adjusts the spatial configuration of the plurality of radiopaque projections comprising the tubular element 148.

[0704] For some applications, each of the radial projections comprising the tubular element 148 is completely radiopaque. For some applications, at least 50% of each projection is radiopaque. The radial projections comprising the tubular element 148 help facilitate viewing of the tissue of the native heart valve annulus and associated tissue under imaging. For some applications, the radial projections comprising the tubular element 148 are positioned against and abut the tissue of the annulus and / or associated tissue (e.g., tissue of the atrial wall and / or tissue of the leaflets of the native valve). For some applications, at least some of the radial projections comprising the tubular element 148 are positioned within the path of blood flow. The radial projections can provide information about the tissue and / or blood flow in response to movement of the tubular element 148.

[0705] 5A-5B, which are schematic illustrations of a system 160 including an implant including an annuloplasty structure 162 including a body portion 164 and an annulus marking device including a plurality of radiopaque protrusions, the plurality of radiopaque protrusions being distributed along and attached to the body portion 164 and shaped to define a plurality of flat planar elements 168, according to some applications. The body portion 164 includes a flexible material, such as a braided fabric mesh. For some applications, the body portion 164 is shaped to define a sleeve shaped to define a lumen through the body portion 164, as shown. For some applications, the body portion 164 is flat. The body portion 164 extends along a central longitudinal axis 161 of the structure 162, and the radiopaque protrusions including the flat planar elements 168 protrude away from the longitudinal axis 161.

[0706] The body portion 164 may comprise a braided fabric mesh, for example, DACRON™. The body portion 164 may be configured to be only partially disposed around the heart valve annulus (e.g., exhibiting a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the structure 162 may be configured to be fully disposed around the annulus (e.g., as a closed circle or other closed shape). To tighten the annulus, the annuloplasty structure 162 comprises a flexible elongated contraction member 165 extending along the body portion 164. The elongated contraction member 165 may comprise a wire, ribbon, rope, or band and may comprise a flexible and / or superelastic material, for example, Nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member 165 comprises a radiopaque material. For some applications, the contraction member 165 comprises a braided polyester suture (e.g., Ticron). For some applications, the contractile member 165 is coated with polytetrafluoroethylene (PTFE). For some applications, the contractile member 165 comprises multiple wires twisted together to form a rope structure.

[0707] The plurality of radiopaque protrusions comprises a flat planar element 168 comprising a flexible fabric. For some applications, the flat planar element 168 and the body portion 164 comprise the same material. The flat planar elements 168 each have a longest dimension measured along an axis that is at a non-zero angle (i.e., not parallel) to the longitudinal axis 161 of the body portion 164.

[0708] Body portion 164 of structure 162 includes a plurality of radiopaque markers 166 positioned at respective longitudinal locations along structure 162. The markers can facilitate setting a desired distance between tissue anchors 167 along body portion 164 and thus provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during an implantation procedure to indicate placement of anchors 167. For some applications, the markers include radiopaque ink. For some applications, the markers include markers of radiopaque material or additional radiopaque material, such as those attached to or incorporated within body portion 164.

[0709] As shown, the contraction member 165 is coupled to the body portion 164 and extends along the body portion 164 through the plurality of flat planar elements 168 such that during application of tension to the contraction member 165, the contraction member 165 is configured to change the structural configuration of the plurality of radiopaque protrusions comprising the flat planar elements 168. As shown in FIG. 5B, the contraction member 165 is configured to change the structural configuration of the elements 168 by compressing and / or folding the elements 168. In such an embodiment, as shown, the contraction member 165 extends along the periphery of each flat planar element 168 such that during application of tension to the contraction member 165, the member 165 is configured to radially compress each flat planar element 168 toward the axis 161 of the structure 162. For some applications, the contraction member is configured to, in turn, change the spatial configuration of the flat planar elements 168.

[0710] For some applications, the contraction member 165 is configured to further apply a contraction force to the body portion 164 of the structure 162 to facilitate adjustment of the circumference of the annuloplasty structure 162. Adjustment of the annuloplasty structure 162 can be performed, for example, by an adjustment mechanism (such as a contraction member and a spool, wheel, spindle, etc.) similar to those described above with respect to the annuloplasty structure 72. For some applications, the system 160 includes an additional contraction member (not shown) configured to adjust the circumference of the body portion 164 as the contraction member 165 adjusts the spatial configuration of the plurality of radiopaque projections comprising the flat planar element 168.

[0711] For some applications, each of the plurality of radial protrusions comprising the flat planar element 168 is completely radiopaque. For some applications, at least 50% of each protrusion is radiopaque. The plurality of radial protrusions comprising the flat planar element 168 aid in facilitating viewing of the tissue of the native heart valve annulus and tissue associated therewith under imaging. For some applications, the plurality of radial protrusions comprising the flat planar element 168 are positioned against and abut the tissue of the annulus and / or tissue associated therewith (e.g., tissue of the atrial wall and / or tissue of the leaflets of the native valve). For some applications, at least some of the plurality of radial protrusions comprising the flat planar element 168 are positioned within the path of blood flow. The plurality of radial protrusions can provide information regarding the tissue and / or blood flow in response to the movement of the flat planar element 168.

[0712] In some applications, anchor 167 includes a biocompatible material, such as stainless steel 316LVM. For some applications, anchor 167 includes Nitinol. For some applications, anchor 167 is completely or partially covered with a non-conductive material.

[0713] 6A, which is a schematic diagram of a system 170 including a tissue anchor 176 having a longitudinal axis 175 measured from a distal end to a proximal end of the distal tissue coupling element 173, and an annulus marking device having a plurality of radiopaque elements, such as filaments 99, coupled to the tissue anchor 176. According to some applications, the filaments 99 or other radiopaque elements include a radiopaque material and protrude away from the axis 175. The distal tissue coupling element 173 is configured to anchor into tissue of the native heart valve annulus 68.

[0714] In some embodiments, the plurality of radiopaque filaments 99 include a radiopaque material (e.g., Nitinol or stainless steel) and are configured to be highly flexible. The filaments 99 protrude away from the anchors 176. According to some applications, the filaments 99 are configured to assist in the implantation of a cardiac device, such as an annuloplasty structure 172, under imaging guidance. The implantation of the anchors 176 and annuloplasty structure 172 is often performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0715] For some applications, the filament 99 wobbles with the movement of blood. For some applications, the filament 99 presses against the tissue of the annulus and tissue connected thereto (such as, for example, tissue of the atrial wall 122 and tissue of the leaflets 123 of the native valve) prior to placement of a portion of the structure 172 along the annulus 68 and prior to puncture of the tissue of the annulus 68 by the distal tip of the anchor 176, as shown in view A of FIG. 6A. That is, the distal tip of the anchor 176 can puncture through a portion of the body portion 174 of the structure 172 and thread the filament 99 through the fabric of the body portion 174, thus pressing the filament 99 against the tissue of the annulus and tissue connected thereto. Thus, the filament 99 provides enhanced imaging of the tissue of the heart valve 64.

[0716] It should be noted that although the system 170 is shown in the mitral valve 64, the system 170 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0717] In some applications, anchor 176 includes a biocompatible material, such as stainless steel 316LVM. For some applications, anchor 176 includes Nitinol. For some applications, anchor 176 is completely or partially covered with a non-conductive material.

[0718] For some applications, each distal tissue-binding element 173 of the anchor 176 is hollow, and the filament 99 can be compressed within the lumen of the hollow element 173 during delivery of the anchor 176 to the atrium of the heart and can expand from within the lumen after entering the atrium.

[0719] The annuloplasty structure 172 may comprise a braided fabric mesh, such as DACRON™. The annuloplasty structure 172 may be configured to be only partially disposed around the heart valve annulus (e.g., exhibiting a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the structure 172 may be configured to be entirely disposed around the annulus (e.g., as a closed circle or other closed shape).

[0720] As shown, for some applications, the annulus marking device comprising filament 99 is coupled to a distal end of distal tissue coupling element 173. Structure 172 comprises a fabric, and the annulus marking device comprising filament 99 is configured to pass through the fabric of structure 172. It should be noted that additional filaments 99 may also be coupled to distal tissue coupling element 173 or any other portion of anchor 176.

[0721] Note that for some applications, the filament 99 may be coupled to an anchor driver that is used to drive the anchor into tissue.

[0722] 6B, which is a schematic illustration of a system 180 including a tissue anchor 176 having a longitudinal axis 175 measured from a distal end to a proximal end of the distal tissue coupling element 173, and an annulus marking device having a plurality of radiopaque filaments 99 coupled to the tissue anchor 176, the filaments 99 including a radiopaque material and protruding away from the axis 175, according to some applications. The distal tissue coupling element 173 is configured to anchor into tissue of the native heart valve annulus 68.

[0723] The plurality of radiopaque filaments 99 can comprise a radiopaque material (e.g., Nitinol or stainless steel) and be configured to be highly flexible. The filaments 99 are coupled to the proximal head 177 of the anchor 176 and protrude away from the anchor 176. According to some applications, the filaments 99 are configured to assist in the implantation of a cardiac device, such as an annuloplasty structure 182, under imaging guidance. The implantation of the anchors 176 and annuloplasty structure 182 is often performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0724] For some applications, the filament 99 wobbles with the movement of the blood, thus providing enhanced imaging of the tissue of the heart valve 64.

[0725] The annuloplasty structure 182 may comprise, by way of example and not limitation, a flat band. The structure 182 may comprise a braided fabric or metal and may not be tubular in shape.

[0726] It should be noted that although the system 180 is shown in the mitral valve 64, the system 180 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0727] For some applications, anchor 176 includes a biocompatible material, such as stainless steel 316LVM. For some applications, anchor 176 includes Nitinol. For some applications, anchor 176 is completely or partially coated with a non-conductive material.

[0728] The annuloplasty structure 182 may comprise a braided fabric mesh, such as DACRON™. The annuloplasty structure 182 may be configured to be only partially disposed around the heart valve annulus (e.g., exhibiting a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the structure 182 may be configured to be entirely disposed around the annulus (e.g., as a closed circle or other closed shape).

[0729] As shown, structure 182 is flat and head 177 is disposed over the flat band after implantation of anchor 176. After implantation in tissue, filament 99 provides an indication that structure 182 has been disposed over a band.

[0730] 7A-7C, which are schematic diagrams of a system 190 including an implant including an annuloplasty structure 192 including a body portion 194 and an annulus marking device including one or more (e.g., two, as shown) planar radiopaque fins 196, according to some applications. The body portion 194 includes a flexible material, such as a braided fabric mesh. For some applications, the body portion 194 is shaped to define a sleeve shaped to define a lumen through the body portion 194, as shown. For some applications, the body portion 194 is flat. The body portion 194 extends along a central longitudinal axis 191 of the structure 192, and the radiopaque fins 196 protrude away from the longitudinal axis 191. The radiopaque fins 196 each have a longest dimension measured along the longitudinal axis 191.

[0731] The body portion 194 may comprise a braided fabric mesh, for example, DACRON™. The body portion 194 may be configured to be only partially disposed around the heart valve annulus (e.g., exhibiting a C-shape) and to contract to circumferentially tighten the annulus after being anchored in place. Optionally, the structure 192 may be configured to be fully disposed around the annulus (e.g., as a closed circle or other closed shape). To tighten the annulus, the annuloplasty structure 192 comprises a flexible, elongated contraction member (not shown) extending along the body portion 194. The contraction member comprises a wire, ribbon, rope, or band, and often comprises a flexible and / or superelastic material, such as Nitinol, polyester, stainless steel, or cobalt chrome. For some applications, the contraction member comprises a radiopaque material. For some applications, the contraction member comprises a braided polyester suture (e.g., Ticron). For some applications, the contraction member is coated with polytetrafluoroethylene (PTFE).For some applications, the contraction member comprises a plurality of wires twisted together to form a rope structure.

[0732] The planar radiopaque fin 196 comprises a flexible fabric. In some applications, the fin 196 and the body portion 194 comprise the same material.

[0733] Body portion 194 of structure 192 includes a plurality of radiopaque markers 195 positioned at respective longitudinal locations along structure 192. The markers can provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during an implantation procedure to effect setting a desired distance between tissue anchors 198 along body portion 194. For some applications, the markers include radiopaque ink. For some applications, the markers include markers of radiopaque material or additional radiopaque material, such as those attached to or incorporated within body portion 164.

[0734] FIG. 7B shows a cross section of structure 172 showing body portion 194 and fins 196.

[0735] In some applications, each of the fins 196 is completely radiopaque. For some applications, at least 50% of each of the fins 196 is radiopaque. The fins 196 help facilitate viewing of the tissue of the native heart valve annulus and associated tissue under imaging. For some applications, the fins 196 are positioned against and abut the tissue of the annulus and / or associated tissue (e.g., tissue of the atrial wall 122 and / or tissue of the native valve leaflets), as shown in FIG. 7C. For some applications, the fins 196 are positioned in the path of blood flow and provide information about the tissue and / or blood flow in response to movement of the fins 196.

[0736] As shown in FIG. 7C, anchors 198 that anchor structure 192 to the tissue of the annulus 68 are designated for implantation between the fins 196.

[0737] For some applications, the fins 196 include shape memory wires that assist in expanding to assume the shape of the fins 196. For some applications, the fabric of the fins 196 is thinner than the fabric of the body portion 194.

[0738] It should be noted that although the system 190 is shown in the mitral valve 64, the system 190 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0739] 8A-8B, which are schematic illustrations of a system 200 including an annulus marking device 202 for assisting in the implantation of a cardiac device under imaging guidance, according to some applications. The device 202 includes a frustoconical scaffold 203 having a plurality of struts 204 collectively arranged in a frustoconical shape. The scaffold 203 is collapsible and expandable. The annulus marking device 202 is configured to extend along at least one side of a body portion 210 of an implant 209 (e.g., an annuloplasty structure, as shown) configured to be positioned along a native heart annulus 68 of a subject's mitral valve 64. As shown, the device 202, when in a frustoconical shape, surrounds a given portion of the body portion 210. The body portion 210 of the implant 209 includes a flexible material and has a longitudinal axis extending along the length of the body portion 210 (e.g., when the body portion is straightened). Body portion 210 includes radiopaque markings 211 to aid in imaging the precise delivery of anchors to the annulus 68 for anchoring the implant 209 to the tissue of the annulus 68 .

[0740] Scaffold 203 comprises a radiopaque material (e.g., Nitinol or stainless steel) and is flexible. Scaffold 203 is coupled to a proximal ring 206 at a proximal end of scaffold 203. For some applications, scaffold 203 comprises ring 206. Ring 206 surrounds at least a portion of body portion 210 of implant 209 and is movable proximally and distally relative to body portion 210 such that scaffold 203 is movable to multiple locations along body portion 210 of implant 209.

[0741] The annulus marking device 202 is coupled to a delivery tool 208 configured to deliver the implant 209 to the valve annulus 68. The annulus marking device 202 is retrievable upon removal of the delivery tool 208 from the subject. For some applications, the scaffold 203 and the ring 206 slide relative to the tool 208. For some applications, the ring 206 is fixedly coupled to the tool 208 and the scaffold 203 moves proximally and distally relative to the body portion 210 in response to movement of the tool 208. The delivery tool 208 is configured to surround a portion of the body portion 210 of the implant 209 and the annulus marking device 202 is configured to at least partially surround the body portion 210 of the implant 209, e.g., to entirely surround a portion of the body portion 210.

[0742] For some applications, a plurality of radiopaque elements, such as radiopaque filaments 99 (or other radiopaque markers, wires, extensions, beads, etc.), are coupled to the scaffold 203 at its distal portion. The plurality of radiopaque elements or filaments 99 function as additional annulus marking devices. According to some applications, the annulus marking device 202 is configured to assist in implantation of the cardiac device under imaging guidance. The steering procedure is performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography.

[0743] The device 202 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. When delivered percutaneously, the device 202 can be made of a superelastic material (e.g., Nitinol or stainless steel) that enables the device 202 to fold and collapse, so that the device 202 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 202 comprises a wire.

[0744] The plurality of radiopaque filaments 99 can comprise a radiopaque material (e.g., Nitinol or stainless steel) and be configured to be highly flexible. For some applications, the filaments 99 oscillate with the movement of blood. For some applications, the filaments 99 press against tissue of the valve annulus and associated tissue (shown in FIG. 8 ), such as tissue of the atrial wall 122 and tissue of the leaflets 123 of the native valve. Thus, the filaments 99 provide enhanced imaging of the tissue of the valve 64.

[0745] For some applications, the delivery tool 208 includes a fin (not shown, but shown in FIG. 10B as fin 227) coupled to a distal portion of the delivery tool 208 and a portion of the scaffold 203, such that movement of the fin in response to blood flow rotates to orient the scaffold 203 relative to the body portion 210 of the implant 209. Thus, the surgeon, with the aid of imaging, is able to distinguish between atrial wall tissue and valve leaflet tissue.

[0746] 8B. For some applications, the plurality of radiopaque elements or filaments 99 includes a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length. The first and second subsets are configured to rotate to orient the scaffold 203 relative to the implant 209. That is, the second subset of filaments 99 having a longer length orients the scaffold 203 such that the second subset of longer filaments 99 are aligned with the tissue of the valve leaflets 123 and the first subset of shorter filaments 99 are aligned with the tissue of the atrial wall 122. For some applications, the plurality of radiopaque filaments 99 includes a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness. The first and second subsets are configured to rotate to orient the scaffold 203 relative to the implant 209. That is, the second subset of filaments 99 having a greater stiffness orients the scaffold 203 such that the second subset of higher stiffness filaments 99 is aligned with tissue of the valve leaflets 123 and the first subset of lower stiffness filaments 99 is aligned with tissue of the atrial wall 122.

[0747] After implantation of the implant 209, the annulus marking device 202 is retrieved. Because the device 202 is flexible and compressible, the device 202 is constrained within a tool during retrieval of the device 202 and subsequent removal of the device 202 from the subject's body. That is, for such embodiments, the device 202 does not function as an implant, but is used only to guide the implantation of the implant 209; rather, the device 202 acts as a guide for implantation when temporarily positioned within the patient's body, and is then removed from the body after implantation of the implant 209.

[0748] It should be noted that although the system 200 is shown in the mitral valve 64, the system 200 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0749] 9A-9B, which are schematic illustrations of a navigation-based guidance system 230, according to some applications, that utilizes one or more longitudinal guides 232 that are configured to facilitate guidance of an implant 231 to a specific portion of an annulus 68 by the guide contacting a surface of the valve (e.g., the annulus, commissures, and / or leaflets of the valve). The guides 232 comprise a flexible material (e.g., a flexible metal such as Nitinol or stainless steel), and each guide 232 is radiopaque. A plurality of eyelets 234 are disposed along a lateral outer surface of a body portion 233 of the implant 231, and each guide 232 (e.g., a distal portion thereof) is disposed within at least some of the eyelets (e.g., the guide is threaded through the eyelet). The eyelets 234 can comprise a suture or fabric.

[0750] In some applications, the eyelets 234 are arranged in longitudinal rows along the length of the body portion 233, and each guide 232 is disposed within the eyelet of each row. In some applications, the eyelets of each row are disposed in the same longitudinal location as the corresponding eyelets of each other row. For some applications, the body portion 233 includes a plurality of radiopaque markers 235, the markers 235 being positioned in respective longitudinal locations along the body portion. For some applications, the eyelets of each row are disposed in the same longitudinal location as the corresponding radiopaque marker. However, the eyelets can be optionally disposed between the radiopaque markers. The guides 232 are disposed at respective circumferential locations around the body portion 233 (e.g., its longitudinal axis). Although each of the three guides is shown in FIGS. 9A-9B to be disposed about 120 degrees from an adjacent guide around the body portion 233, this range includes other arrangements, such as two guides disposed opposite each other.

[0751] For some applications, each guide 232 comprises a wire having a loop portion 238, such that the guide has (1) two parallel linear portions of the wire and (2) a loop portion at the distal end 236 of the guide.

[0752] For some applications, distal end 236 of each guide 232 is biased (e.g., shape-set) to protrude radially outward from body portion 233. Such a bias can impart a desired behavior to the guide, for example, as the guide moves distally. For example, when the guide is moved distally relative to tissue, the bias can facilitate spreading the guide over the tissue (e.g., as described below). Alternatively or additionally, after the guide is withdrawn proximally from a given eyelet, the next time the guide is moved distally again, the bias can inhibit (e.g., prevent) the guide from being threaded again through the given eyelet.

[0753] Body portion 233 is configured to be advanced distally from delivery tool 208 and anchored to valve annulus 68 using the anchor.

[0754] Guides 232 are positioned (e.g., pressed) against the tissue of the valve, such as by being pre-positioned distally against the distal end of body portion 233, or by advancing distally after the distal end of the body portion itself has been positioned against the tissue of the valve, such that each guide 232 (e.g., its loop portion 238) includes a tissue-engaging portion configured to contact the tissue of the target.

[0755] In one or more ways, the behavior of guide 232 in response to being positioned against the valve tissue facilitates guidance by viewing body portion 233 (e.g., positioning of the body portion at the valve annulus).

[0756] Resistance of the guide to being pushed further distally can indicate that the guide is in contact with tissue that will withstand the force applied by the guide. For example, the distal end of the guide can abut the valve annulus 68 and / or the wall 122 of the atrium (as shown in FIG. 9B). Conversely, lack of resistance of the guide to being pushed further distally can indicate that the distal end of the guide is not in contact with tissue that will withstand the force applied by the guide. For example, the distal end of the guide can move between the leaflets 123 of the valve (e.g., at the commissures) and / or push the leaflets 123 downward (e.g., into the ventricle). Such resistance (or lack thereof) can be detected mechanically (e.g., as tactile feedback to the surgeon and / or by an external control unit). Because the guide 232 includes a radiopaque material, such resistance (or lack thereof) can be detected via imaging (e.g., fluoroscopy).

[0757] Similarly, the position, orientation, and / or shape of the guide (e.g., relative to one or more other guides, the body portion 233 of the implant 231, the tissue of the valve, etc.) can indicate what, if anything, the guide is positioned relative to. Imaging techniques such as fluoroscopy can be used to identify this position, orientation, and / or shape of the guide. For example, if the distal end of the guide is positioned at the same height (i.e., the same placement in the superior-subject axis) as the distal end of the body portion 233, this can indicate that the body portion 233 and the guide 232 abut against the same surface (e.g., the valve annulus 68). Conversely, if the distal end of the guide 232 is positioned lower than the body portion 233, this can indicate that the body portion 233 is positioned relative to the valve annulus 68 and that the guide 232 has advanced toward or into the ventricle. Movement of the guide (e.g., beating) can indicate that the guide is positioned relative to the leaflets of the valve and that the leaflets are moving the guide as the heart beats. Such imaging can be facilitated by one or more components comprising radiopaque markings. For some applications, each guide 232 has a different radiopaque marking for ease of identification during imaging.

[0758] One or more of the guides 232 can constrain movement of the body portion 233 of the implant 231. For example, if the guide extends between the leaflets at the commissures, the guide can constrain movement of the body portion 233 away from the commissures.

[0759] The guides 232 can be collectively or individually configured and / or selected to behave in a particular way when they interact with tissue. For example, the guides can be configured and / or selected to be (1) rigid enough to provide tactile feedback when they contact tissue, and / or (2) flexible enough to span over tissue without damaging it and / or to be movable by the beating of the leaflets.

[0760] FIG. 9B shows the body portion 233 positioned against the target annulus 68 near the left fibrous trigone. The guides 232 are pushed distally and spread across the annulus 68, e.g., due to resistance of the annulus (see FIG. 9B, view A). As described above, this can be detected mechanically and / or by imaging. The guides 232a are also pushed distally and extend between the leaflets 123 at the commissures (see FIG. 9B, view B). As described above, this can be detected mechanically and / or using imaging. The position, orientation, and / or shape of each guide, alone and / or in combination with other guides and / or elements, indicates that a portion of the body portion 233 has been positioned against firm tissue near the commissures, which for some applications is a preferred location for anchoring a portion of the body portion 233. Identification of which guides are in which position (e.g., by mechanical and / or imaging) can further indicate the rotational orientation of the body portion 233.

[0761] After the desired location is identified, an anchor (e.g., a first anchor) is used to anchor body portion 233. For some applications, one or more of guides 232 may be withdrawn slightly proximally prior to anchoring, e.g., to reduce the chance of inadvertently anchoring the guide to tissue. An additional portion of body portion 233 is then anchored to annulus 68. In some applications, guide 232 is moved proximally relative to body portion 233. This process may be repeated for each anchor until implant 231 is fully implanted.

[0762] It should be noted that although the system 230 is shown in the mitral valve 64, the system 230 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0763] 10A-10B, which are schematic illustrations of a system 220 including an annulus marking device 222 for assisting in the implantation of a cardiac device under imaging guidance, according to some applications. The device 222 includes a generally triangular scaffold 223 having a plurality of struts 204 collectively arranged in a generally triangular shape. The scaffold 223 is collapsible and expandable. The annulus marking device 222 is configured to extend along at least one side of a body portion 210 of an implant 209 (e.g., an annuloplasty structure, as shown) configured to be positioned along a native heart annulus 68 of a subject mitral valve 64. As shown, the device 222 is positioned anteriorly, in front of the body portion 210. The device 222 guides the implant 209. Body portion 210 of implant 209 comprises a flexible material and has a longitudinal axis extending along the length of body portion 210 (e.g., when the body portion is straightened). Body portion 210 includes radiopaque markings to assist in imaging the precise delivery of anchors to the annulus 68 for anchoring implant 209 to the tissue of the annulus 68.

[0764] Scaffold 223 comprises a radiopaque material (e.g., Nitinol or stainless steel) and is flexible. Scaffold 223 is coupled to a proximal ring 226 at a proximal end of scaffold 223. For some applications, scaffold 223 comprises ring 226. Ring 226 surrounds at least a portion of body portion 210 of implant 209 and is movable proximally and distally relative to body portion 210 such that scaffold 223 is movable to multiple locations along body portion 210 of implant 209. For some applications, scaffold 223 is semi-tubular.

[0765] The annulus marking device 222 is coupled to a delivery tool 208 configured to deliver the implant 209 to the valve annulus 68. The annulus marking device 222 is retrievable when the delivery tool 208 is removed from the subject. For some applications, the scaffold 223 and the ring 226 are configured to slide relative to the tool 208. For some applications, the scaffold 223 and the ring 226 are configured to rotate relative to the delivery tool 208. For some applications, the ring 226 is fixedly coupled to the tool 208 and the scaffold 223 moves proximally and distally relative to the body portion 210 in response to movement of the tool 208. The delivery tool 208 is configured to surround a portion of the body portion 210 of the implant 209 and the annulus marking device 222 is configured to at least partially surround the body portion 210 of the implant 209, for example, on a single side of the body portion 210 as shown.

[0766] For some applications, scaffold 223 is planar and triangular, as shown, For some applications, scaffold 223 is semi-tubular.

[0767] For some applications, a plurality of radiopaque elements, such as radiopaque filaments 99 (or other radiopaque markers, wires, extensions, beads, etc.), are coupled to the scaffold 223 at its distal portion. The plurality of radiopaque elements or filaments 99 function as additional annulus marking devices. According to some applications, the annulus marking device 222 is configured to assist implantation of the cardiac device under imaging guidance. The steering procedure is performed with the assistance of imaging, such as fluoroscopy, transesophageal echocardiography, and / or echocardiography. In some embodiments, a first subset of the filaments 99 contacts the atrial wall 122, a second subset of the filaments 99 contacts the valve annulus 68, a third subset of the filaments 99 contacts the valve leaflets 123, and a fourth subset of the filaments 99 extends over the valve opening between the leaflets 123.

[0768] The device 222 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. When delivered percutaneously, the device 222 can be made of a superelastic material (e.g., Nitinol or stainless steel) that enables the device 222 to fold and collapse, so that the device 222 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 222 comprises a wire.

[0769] The plurality of radiopaque filaments 99 can comprise a radiopaque material (e.g., Nitinol or stainless steel) and be configured to be highly flexible. For some applications, the filaments 99 oscillate with the movement of blood. For some applications, the filaments 99 press against tissue of the annulus and associated tissue (shown in FIG. 10 ), such as tissue of the atrial wall 122. Thus, the filaments 99 provide enhanced imaging of the tissue of the valve 64.

[0770] 10B. For some applications, the delivery tool 208 includes a fin 227 coupled to a distal portion of the delivery tool 208 and a portion of the scaffold 223, such that movement of the fin 227 in response to blood flow orients the scaffold 223 relative to the body portion 210 of the implant 209 by rotation. Thus, the surgeon can distinguish between tissue of the atrial wall and tissue of the valve leaflets with the aid of imaging. For some applications, the fin 227 is radiopaque. For some applications, a distal portion of the fin 227 extends into the ventricle.

[0771] 8B and 10A-10B. For some applications, the plurality of radiopaque filaments 99 includes a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length. The first and second subsets are configured to rotate to orient the scaffold 223 relative to the implant 209. That is, the second subset of filaments 99 having a longer length orients the scaffold 223 such that the second subset of longer filaments 99 are aligned with the tissue of the valve leaflet 123 and the first subset of shorter filaments 99 are aligned with the tissue of the atrial wall 122. For some applications, the plurality of radiopaque filaments 99 includes a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness. The first and second subsets are configured to rotate to orient the scaffold 223 relative to the implant 209. That is, the second subset of filaments 99 having a greater stiffness orients the scaffold 223 such that the second subset of higher stiffness filaments 99 is aligned with tissue of the valve leaflets 123 and the first subset of lower stiffness filaments 99 is aligned with tissue of the atrial wall 122.

[0772] For some applications, a first subset of the filaments 99 contacts the atrial wall 122, a second subset of the filaments 99 contacts the valve annulus 68, a third subset of the filaments 99 contacts the valve leaflets 123, and a fourth subset of the filaments 99 extends over the valve opening and between the leaflets 123.

[0773] 10A-10B, in some applications, the device 222 is configured to be disposed between the implant 209 and tissue of the atrial wall 122, as shown.

[0774] After implantation of the implant 209, the annulus marking device 222 is retrieved. Because the device 222 is flexible and compressible, the device 222 is constrained within a tool during retrieval of the device 222 and subsequent removal of the device 222 from the subject's body. That is, for such embodiments, the device 222 does not function as an implant and is used only to guide the implantation of the implant 209; rather, the device 222 acts as a guide for implantation when temporarily positioned within the patient's body and is then removed from the body following implantation of the implant 209.

[0775] It should be noted that although the system 220 is shown in the mitral valve 64, the system 220 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0776] 11A-11C, which are schematic illustrations of a system 250 including an annulus marking device 252, according to certain applications, comprising a tubular stent body 254 having a central longitudinal axis 251 and a plurality of extensions 256 coupled to a proximal end of the tubular stent body 254 and projecting away from the longitudinal axis 251 of the stent body 254. The annulus marking device 252 is configured to be placed within a native heart valve of interest, such as the mitral valve 64 as shown, the tricuspid valve, or any other heart valve.

[0777] The plurality of extensions 256 are configured to be positioned along the circumference of the annulus 68 of the valve 64. In some applications, an annulus marking device is positioned within the valve 64 prior to implanting the implant along the annulus 68, thus configured to provide a guide for implanting the implant along the annulus during implantation. For some applications, the tubular stent body 254 includes two or more leaflets to regulate blood flow when the device 252 is positioned within the valve 64. The device 252 is compressible during delivery to the valve 64 and expandable from a compressed state for positioning within the native heart valve 64. After the device 252 is positioned within the valve 64, the valve is imaged, for example, using fluoroscopy. The extensions 256 provide an indication of the circumference of the annulus 68.

[0778] The device 252 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables the device 252 to bend and collapse so that it can be delivered within a catheter. Additionally, the device 252 is made from a radiopaque material to facilitate visualization with fluoroscopy. In some applications, the tissue of the annulus 68 and associated tissues are viewed using the multiple extensions 256. Additionally, the tissue of the native heart annulus 68 and associated tissues are viewed by imaging the annulus marking device 252 against the tissue of the native heart annulus and associated tissues by viewing the multiple extensions 256 against the tissue. For some applications, the tissue of the native heart annulus 68 and associated tissues are viewed by imaging the annulus marking device 252 against the tissue of the native heart annulus and associated tissues by viewing the movement of the multiple extensions 256 in response to the movement of the tissue.

[0779] After positioning the device 252 within the valve 64, an implant comprising an annuloplasty structure 259 is positioned along the annulus 68 under imaging, as shown in FIG. 11B. The structure 259 comprises a body portion 260, e.g., a tubular body portion, through which a plurality of anchors 264 are deployed. The structure 259 comprises a plurality of radiopaque markers 262, which are positioned at respective longitudinal locations along the structure 259. The markers can provide an indication in a radiographic image (e.g., a fluoroscopic image) of how much of the body portion has been deployed at any given point during the implantation procedure to effect setting a desired distance between tissue anchors along the body portion. For some applications, the marker comprises a radiopaque ink. For some applications, the marker comprises a radiopaque material attached to or incorporated within the body portion 164.

[0780] The anchors 264 are delivered to the valve 64 to anchor the structure 259 to the valve annulus 68 by deploying each of the anchors 264 between adjacent extensions 256 of the device 252. In addition to the imaging guidance provided by the radiopaque extensions 256, the markers 262 of the structure 259 aid in the deployment of the anchors 264.

[0781] After anchoring of structure 259 to the valve annulus 68, the annulus marking device 252 is constrained within the catheter such that the tubular stent body 254 collapses and the extensions 256 follow behind the body 254 such that the extensions 256 slide out from under the implanted annuloplasty structure 259 along the valve annulus 68. The annulus marking device 252 is retrieved and removed from the subject's body.

[0782] After implantation of the structure 259, the annulus marking device 252 is retrieved. Because the device 252 is flexible and compressible, the device 252 is constrained within a tool during retrieval of the device 252 and subsequent removal of the device 252 from the subject's body. That is, for such embodiments, the device 252 does not function as an implant, but is used only to guide the implantation of the annuloplasty structure 259 (i.e., an implant); rather, the device 252 acts as a guide for implantation when temporarily positioned within the patient's body, and is then removed from the body following implantation of the annuloplasty structure 259.

[0783] It should be noted that although the system 250 is shown in the mitral valve 64, the system 250 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0784] 12A-12B, which are schematic illustrations of a system 270 for facilitating imaging of cardiac tissue during implantation of a cardiac implant, according to some applications, the system 270 includes a valve annulus marking device including a mapping catheter 272. The mapping catheter 272 is percutaneously (e.g., transvascularly) introduced toward the mitral valve 64, as shown. It should be noted that the catheter 272 can be advanced to the tricuspid valve and / or any other cardiac valve. The mapping catheter 272 includes multiple mapping subunits 274. For some applications, the subunits 274 include electrodes, and mapping of the valve 64 is performed electrophysiologically, using an electroanatomical mapping system that uses the electrodes. For some applications, the subunits 274 include magnets, and mapping of the valve 64 is performed under magnetic imaging by generating a magnetic field. For some applications, the subunits 274 include a radiopaque material, and imaging is performed under fluoroscopy, or the like.

[0785] As shown in FIG. 12B, after a map of the valve 64 is generated using the mapping catheter 272, an implant, for example an annuloplasty structure 271, is placed in the valve 64 using the map as a guide. In some applications, the structure 271 comprises a flexible body portion 275. For some applications, the body portion of the structure 271 is shaped to define a tubular sleeve through which a plurality of anchors 277 are implanted. The body portion of the structure 271 comprises a plurality of radiopaque markers 273, which are positioned at respective longitudinal sites along the structure 271. The markers can provide an indication in a radiographic image (such as a fluoroscopic image) of how much of the body portion has been deployed at any given point during the implantation procedure to effect setting a desired distance between tissue anchors along the body portion. For some applications, the markers include radiopaque ink. For some applications, the markers include markers of radiopaque material or additional radiopaque material, such as those attached to or incorporated within body portion 164 .

[0786] For some applications, the mapping catheter 272 is removed prior to implantation of the structure 271, and the structure 271 is implanted under the guidance of a map 276 generated by the mapping catheter 272, which can be stored and displayed by an imaging device. For some applications, the mapping catheter 272 remains in the annulus 68 during implantation of the structure 271 and is viewed under fluoroscopy. For some applications, the mapping catheter 272 facilitates viewing and mapping the tissue of the native heart valve annulus and tissue associated therewith using the mapping catheter 272. For some applications, the mapping catheter 272 facilitates viewing and mapping the tissue of the native heart valve annulus and tissue associated therewith by viewing the mapping catheter 272 relative to the tissue. For some applications, the mapping catheter 272 facilitates viewing and mapping the tissue of the native heart valve annulus and tissue associated therewith by viewing the movement of the mapping catheter 272 in response to the movement of the tissue.

[0787] It should be noted that although the system 270 is shown in the mitral valve 64, the system 270 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0788] 13, which is a schematic illustration of a system 280 including an annulus marking device 282 for facilitating imaging of cardiac tissue during implantation of a cardiac implant, according to some applications, the annulus marking device 282 including a plurality of expandable elements 286 that form the device 282 into a generally spherical shape. The device 282 includes a flexible, radiopaque material, such as Nitinol or stainless steel, that facilitates folding and expanding the device 282.

[0789] As shown, device 282 aids in imaging the implantation of a cardiac implant, such as an annuloplasty structure 288, as shown. Structure 288 includes a body portion 290 that includes a flexible material and has a longitudinal axis extending along the length of body portion 290 (e.g., when the body portion is straightened). Body portion 290 includes radiopaque markings 292 to aid in imaging the precise delivery of anchors 296 to the annulus 68 for anchoring implant 288 to the tissue of the annulus 68.

[0790] The annulus marking device 282 is delivered using a delivery tool 284 configured to deliver the device 282 in a compressed state to the left atrium. The device 282 is configured to expand from its compressed state after being deployed from within the lumen of the tool 284. The annulus marking device 282 is retrievable upon removal of the delivery tool 284 from the subject. That is, the device 282 is constrained within the lumen of the tool 284 after the cardiac implant is implanted into the valve annulus 68. The device 282 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgical techniques. When delivered percutaneously, the device 282 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables the device 282 to fold and collapse, such that the device 282 can be delivered within a catheter that can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, device 282 comprises a wire.

[0791] After entering the atrium, the plurality of expandable elements 286 expand radially within the atrium, such that the plurality of expandable elements 286 provide an indication of the location of the native heart valve annulus 68 of the native heart valve 64. It should be noted that although the device 282 is used within the left atrium, the device 282 may also be used within the right atrium, left ventricle, and right ventricle.

[0792] The plurality of expandable elements 286 collectively form the annulus marking device 282 into a generally spherical shape. As shown, the plurality of expandable elements 286 comprise a plurality of curved wires. For some applications, the plurality of expandable elements 286 surround a central shaft 285. A proximal end and a distal end of each expandable element 286 are coupled to the shaft 285.

[0793] The collective proximal diameter Di1 of the proximal ends of the plurality of expandable elements 286 is equal to the collective distal diameter Di3 of the distal ends of the plurality of expandable elements 286. The collective intermediate diameter Di2 of the plurality of expandable elements 286 is greater than the collective proximal diameter Di1 and greater than the collective distal diameter Di3.

[0794] The annulus 68 is then imaged using fluoroscopy. In some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the plurality of expandable elements 286 relative to the tissue. For some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the movement of the plurality of expandable elements 286 in response to movement of the tissue. In either application, the annulus marking device 282 is imaged relative to the tissue of the native heart annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0795] 3A-3B and 13. For some applications, the annulus marking device 282 is coupled to a plurality of radiopaque elements or filaments 99. In some applications, the annulus marking device 282 and the elements or filaments 99 are imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the plurality of expandable elements 286 and the radiopaque elements or filaments 99 relative to the tissue. For some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the movement of the plurality of expandable elements 286 and the filaments 99 in response to the movement of the tissue. For either application, the annulus marking device 282 and the radiopaque elements or filaments 99 are imaged relative to the tissue of the native heart annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0796] Referring again to Figure 13, the annuloplasty structure 288 is implanted under fluoroscopic guidance using the annulus marking device 282 as a guide. The annuloplasty structure 288 is positioned between the annulus marking device 282 and the atrial wall 122. Respective anchors 296 are deployed to anchor the structure 288 along the annulus 68 at sites marked between successive curved wires of the element 286.

[0797] After the annuloplasty structure 288 has been implanted, the device 282 is restrained within a tool 284 and withdrawn from the subject.

[0798] After implantation of the structure 288, the annulus marking device 282 is retrieved. Because the device 282 is flexible and compressible, the device 282 is constrained within a tool during retrieval of the device 282 and subsequent removal of the device 282 from the subject's body. That is, for such embodiments, the device 282 does not function as an implant, but is used only to guide the implantation of the annuloplasty structure 288 (i.e., an implant); rather, the device 282 acts as a guide for implantation when temporarily positioned within the patient's body, and is then removed from the body following implantation of the annuloplasty structure 288.

[0799] It should be noted that although the system 280 is shown in the mitral valve 64, the system 280 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0800] 14, which is a schematic illustration of a system 300 including an annulus marking device 302 for facilitating imaging of cardiac tissue during implantation of a cardiac implant, according to some applications, the annulus marking device 302 including a plurality of expandable elements 301 that form the device 302 into a generally spherical or bulbous shape. The plurality of expandable elements 301 of the device 302 include a flexible radiopaque material that facilitates folding and expansion of the device 302, such as a woven radiopaque fabric including Nitinol® or stainless steel. The plurality of expandable elements 301 of the device 302 collectively present a mesh.

[0801] As shown, device 302 aids in imaging the implantation of a cardiac implant, for example, annuloplasty structure 308, as shown. Structure 308 comprises a body portion 307, which comprises a flexible material and has a longitudinal axis extending along the length of body portion 307 (e.g., when the body portion is straightened). Body portion 307 includes radiopaque markings 309 to aid in imaging the precise delivery of anchors 310 to valve annulus 68 for anchoring structure 308 to tissue of the annulus 68. Structure 308 is delivered using delivery tool 305.

[0802] The annulus marking device 302 is delivered using a delivery tool 304 configured to deliver the device 302 in a compressed state to the left atrium. The device 302 is configured to expand from its compressed state after being deployed from within the lumen of the tool 304. The annulus marking device 302 is retrievable upon removal of the delivery tool 304 from the subject. That is, the device 302 is constrained within the lumen of the tool 304 after the cardiac implant is implanted into the valve annulus 68. The device 302 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. When delivered percutaneously, the device 302 can be made from a superelastic material (e.g., Nitinol or stainless steel) that enables the device 302 to fold and collapse, such that the device 302 can be delivered within a catheter, which can then self-expand to a desired shape and tension upon release from the catheter. For example, percutaneous vascular access into the femoral or jugular vein can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 302 comprises a wire.

[0803] It should be noted that although the device 302 is shown delivered via the aorta, any suitable delivery route may be used to deliver the device 302 into the atrium.

[0804] After entering the atrium, the plurality of expandable elements 301 expand radially within the atrium, such that the plurality of expandable elements 301 provide an indication of the location of the native heart valve annulus 68 of the native heart valve 64. It should be noted that although the device 302 is used within the left atrium, the device 302 may also be used within the right atrium, left ventricle, and right ventricle.

[0805] The annulus 68 is then imaged using fluoroscopy. In some applications, the annulus marking device 302 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the plurality of expandable elements 301 relative to the tissue. For some applications, the annulus marking device 302 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the movement of the plurality of expandable elements 301 in response to the movement of the tissue. In either application, the annulus marking device 302 is imaged relative to the tissue of the native heart annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0806] 3A-3B and 14. For some applications, the annulus marking device 302 is coupled to a plurality of radiopaque elements, such as radiopaque filaments 99, or other radiopaque markers, wires, extensions, beads, or the like. In some applications, the annulus marking device 302 and the radiopaque elements or filaments 99 are imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the plurality of expandable elements 301 and the radiopaque elements or filaments 99 relative to the tissue. For some applications, the annulus marking device 302 is imaged relative to the tissue of the native heart annulus 68 and associated tissue by viewing the movement of the plurality of expandable elements 301 and the radiopaque elements or filaments 99 in response to the movement of the tissue. For either application, the annulus marking device 302 and the radiopaque elements or filaments 99 are imaged relative to the tissue of the native heart annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0807] The annuloplasty structure 308 is implanted under fluoroscopic guidance using the annulus marking device 302 as a guide. The annuloplasty structure 308 is positioned between the annulus marking device 302 and the atrial wall 122. Respective anchors 310 are deployed to anchor the structure 308 along the annulus 68 at sites marked between successive curved wires of element 301.

[0808] After the annuloplasty structure 308 has been implanted, the device 302 is constrained within the tool 304 and withdrawn from the subject.

[0809] After implantation of the structure 308, the annulus marking device 302 is retrieved. Because the device 302 is flexible and compressible, the device 302 is constrained within a tool during retrieval of the device 302 and subsequent removal of the device 302 from the subject's body. That is, for such embodiments, the device 302 does not function as an implant, but is used only to guide the implantation of the annuloplasty structure 308 (i.e., an implant); rather, the device 302 acts as a guide for implantation when temporarily positioned within the patient's body, and is then removed from the body following implantation of the annuloplasty structure 308.

[0810] It should be noted that although the system 300 is shown in the mitral valve 64, the system 300 may be used in any heart valve, for example the tricuspid valve, or in any other tissue of interest.

[0811] 15, which is a schematic diagram of a system 320 including an implant, e.g., an annu...

Claims

1. 1. An apparatus for use with a subject, comprising:

1. A valve annulus marking device comprising a radiopaque material, (1) a base frame having a shape that follows the circumference of a native heart valve annulus; and (2) a valve annulus marking device configured to define one or more struts projecting away from a plane defined by the foundation frame, the one or more struts providing indication of one or more commissures of a native heart valve; compressible during delivery to the native heart valve; expandable from a compressed state for positioning along the native heart valve annulus. a valve annulus marking device; an implant for implantation along the native heart valve annulus of the subject; Equipped with The annulus marking device comprises: configured to provide a visual or tactile and mechanical guide for implanting the implant along the valve annulus during implantation; The device is retrievable following implantation of said implant.

2. The apparatus of claim 1 , wherein the annulus marking device comprises a superelastic material.

3. The apparatus of claim 1 or 2, wherein the foundation frame and the one or more columns are fabricated from a single piece.

4. The device of claim 1 , wherein the one or more struts are sized to provide an indication as to the height of the native heart valve annulus.

5. 5. The apparatus according to claim 1, wherein the base frame is circular.

6. 5. Apparatus according to any one of claims 1 to 4, wherein the foundation frame is substantially D-shaped.

7. The apparatus of claim 1 , wherein the foundation frame comprises wires.

8. 8. The apparatus of claim 1 , wherein the foundation frame includes an adjustment mechanism for expanding and contracting the perimeter of the foundation frame.

9. The device of claim 8 , wherein the adjustment mechanism comprises a wire that passes at least partially through a lumen of the foundation frame, the wire being capable of being pulled to adjust a circumference of the foundation frame.

10. The device of claim 8 , wherein the adjustment mechanism comprises a wire that passes at least partially through a lumen of the foundation frame, the wire being twistable to adjust a circumference of the foundation frame.

11. The device of claim 8 , wherein the adjustment mechanism comprises a wire passing at least partially through a lumen of the foundation frame, and at least a portion of the foundation frame is telescopically folded in response to the wire being pulled.

12. 12. The apparatus of claim 1, wherein the annulus marking device comprises a plurality of radiopaque filaments at least coupled to the base frame, each of the plurality of filaments protruding radially away from the base frame and configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

13. The device of claim 12 , wherein each of the plurality of radiopaque filaments comprises a flexible material.

14. Placing an annulus marking device comprising a radiopaque material at a native heart valve annulus of a subject, the annulus marking device comprising: (1) a base frame having a shape that follows the circumference of the native heart valve annulus; and (2) a valve annulus marking device configured to define one or more struts projecting away from a plane defined by the foundation frame, the one or more struts being provided with indicia of one or more commissures of a native heart valve; compressible during delivery to the native heart valve; expandable from a compressed state for positioning along the native heart valve annulus; implanting the implant along the subject's native heart annulus using the annulus marking device as a visual guide or a tactile and mechanical guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

15. 15. The method of claim 14, wherein placing the annulus marking device comprises measuring annulus height using the annulus marking device.

16. 16. The method of claim 14 or 15, further comprising the step of adjusting a perimeter of the foundation frame.

17. 17. The method of any one of claims 14 to 16, wherein implanting under imaging comprises implanting using fluoroscopy.

18. 18. The method of any one of claims 14 to 17, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device in a tool and extracting the annulus marking device from the subject.

19. 19. The method of any one of claims 14 to 18, wherein the step of placing comprises placing the annulus marking device along an annulus of a mitral valve.

20. 19. The method of any one of claims 14 to 18, wherein the step of placing comprises placing the annulus marking device along an annulus of a tricuspid valve.

21. 21. The method of any one of claims 14 to 20, wherein the annulus marking device includes a plurality of radiopaque filaments at least coupled to the base frame, each of the plurality of radiopaque filaments protruding radially away from the base frame, and the method further includes the step of using the plurality of radiopaque filaments to view tissue of the native heart annulus and tissue coupled thereto.

22. 22. The method of claim 21 , wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments relative to the tissue.

23. 23. The method of claim 22, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

24. 22. The method of claim 21 , wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

25. 1. An apparatus for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device including a plurality of radiopaque protrusions protruding away from the longitudinal axis; a contraction member coupled to the body portion and extending along the body portion; wherein the contraction member extends through the plurality of radiopaque protrusions such that during application of tension to the contraction member, the contraction member is configured to change a structural configuration of the plurality of radiopaque protrusions.

26. 26. The apparatus of claim 25, wherein the contraction member is configured to radially compress the plurality of radiopaque protrusions toward a longitudinal axis of the body portion.

27. 27. The apparatus of claim 25 or 26, wherein the contraction member is configured to contract the body portion during application of tension to the contraction member.

28. 27. The apparatus of claim 26, further comprising an additional contraction member extending along the body portion, the additional contraction member configured to contract the body portion.

29. 29. The apparatus of any one of claims 25 to 28, wherein the body portion comprises a plurality of radiopaque markings positioned at respective longitudinal locations along the body portion.

30. 30. The apparatus of any one of claims 25 to 29, wherein the contraction member extends around a periphery of each of the plurality of radiopaque protrusions.

31. 31. The apparatus of any one of claims 25 to 30, wherein the plurality of radiopaque protrusions are flexible and comprise fabric.

32. 32. The apparatus of any one of claims 25-31, wherein the body portion and the plurality of radiopaque protrusions are flexible and comprise fabric.

33. 33. The apparatus of any one of claims 25 to 32, wherein each of the plurality of radiopaque protrusions is shaped to define a respective flat planar element.

34. 34. The apparatus of claim 33, wherein each flat planar element has a longest dimension measured along an axis that forms a non-zero angle with respect to a longitudinal axis of the body portion.

35. 33. The apparatus of any one of claims 25 to 32, wherein each of the plurality of radiopaque protrusions is shaped to define a plurality of tubular elements.

36. 36. The apparatus of claim 35, wherein the constriction member extends around a periphery of the opening of each of the plurality of tubular elements.

37. 36. The apparatus of claim 35, wherein each of the plurality of tubular elements tapers away from the longitudinal axis of the body portion.

38. Placing an implant at a subject's native heart valve annulus, the implant being configured to be positioned along the native heart valve annulus, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; an annulus marking device including a plurality of radiopaque protrusions protruding away from the longitudinal axis; and including a contraction member coupled to and extending along the body portion, the contraction member extending through the plurality of radiopaque projections such that during application of tension to the contraction member, the contraction member is configured to change a structural configuration of the plurality of radiopaque projections; deploying, under imaging, a plurality of tissue anchors through the body portion of the implant and into tissue of the native heart annulus using the annulus marking device as a visual guide or a tactile and mechanical guide; applying tension to the contraction member to thereby change a structural configuration of the plurality of radiopaque protrusions; The method includes:

39. 40. The method of claim 38, wherein altering the structural configuration of the plurality of radiopaque protrusions comprises radially compressing the plurality of radiopaque protrusions toward a longitudinal axis of the body portion.

40. 40. The method of claim 38 or 39, wherein applying tension to the contraction member comprises adjusting a circumference of the implant by using the contraction member to contract the body portion.

41. 40. The method of claim 38 or 39, wherein the implant includes an additional contraction member extending along the body portion, the method further comprising adjusting a circumference of the implant by contracting the body portion using the additional contraction member.

42. 42. The method of any one of claims 38 to 41, wherein the step of placing comprises placing the implant along an annulus of a mitral valve.

43. 42. The method of any one of claims 38 to 41, wherein the step of placing comprises placing the implant along an annulus of a tricuspid valve.

44. 44. The method of any one of claims 38 to 43, wherein varying the structural configuration of the plurality of radiopaque protrusions comprises sequentially varying the structural configuration of the plurality of radiopaque protrusions.

45. 45. The method of any one of claims 38 to 44, wherein the body portion includes a plurality of radiopaque markings positioned at respective longitudinal locations along the body portion, and wherein deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors in accordance with the respective radiopaque markings.

46. 46. ​​The method of any one of claims 38 to 45, wherein the contraction member extends along a periphery of each of the plurality of radiopaque protrusions, and the step of changing the structural configuration of the plurality of radiopaque protrusions includes the step of compressing the plurality of radiopaque protrusions by contracting the contraction member along a periphery of each of the plurality of radiopaque protrusions, thereby drawing each of the plurality of radiopaque protrusions toward a longitudinal axis.

47. 47. The method of any one of claims 38 to 46, wherein the plurality of radiopaque protrusions are flexible and comprise fabric.

48. 48. The method of any one of claims 38 to 47, wherein each of the plurality of radiopaque protrusions is shaped to define a plurality of flat, planar elements, and the step of altering the structural configuration of the plurality of radiopaque protrusions comprises the step of pulling each of the plurality of radiopaque protrusions toward a longitudinal axis by bending each of the plurality of flat, planar elements.

49. 48. The method of any one of claims 38 to 47, wherein each of the plurality of radiopaque protrusions is shaped to define a plurality of tubular elements.

50. 50. The method of claim 49, wherein the contraction member extends around a periphery of an opening in each of the plurality of tubular elements, and changing the structural configuration of the plurality of radiopaque protrusions includes closing the opening in each of the plurality of tubular elements.

51. 50. The method of claim 49, wherein each of the plurality of tubular elements tapers away from the longitudinal axis of the body portion.

52. 52. The method of any one of claims 38 to 51, wherein the method further comprises the step of viewing tissue of the native heart valve annulus and tissue associated therewith under imaging of the plurality of radiopaque protrusions.

53. 53. The method of claim 52, wherein viewing the tissue comprises imaging using fluoroscopy.

54. 53. The method of claim 52, wherein viewing the tissue of the native heart valve annulus and associated tissue comprises imaging the plurality of radiopaque protrusions relative to the tissue of the native heart valve annulus and associated tissue by viewing the plurality of radiopaque protrusions relative to the tissue.

55. 55. The method of claim 54, wherein viewing the plurality of radiopaque protrusions comprises viewing movement of the plurality of radiopaque protrusions in response to movement of the tissue.

56. 53. The method of claim 52, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

57. a tissue anchor comprising a distal tissue coupling element having a longitudinal axis measured from a distal end to a proximal end of the distal tissue coupling element, the distal tissue coupling element configured to anchor to tissue of a native heart valve annulus; a valve annulus marking device coupled to the tissue anchor, the valve annulus marking device comprising a radiopaque material and configured to protrude away from a longitudinal axis of the distal tissue coupling element; A system comprising:

58. 58. The system of claim 57, wherein the distal tissue coupling element is hollow and the annulus marking device extends through a lumen of the distal tissue coupling element.

59. 58. The system of claim 57, wherein the tissue anchor comprises a proximal head coupled to a proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

60. 60. The system of claim 59, further comprising an annuloplasty structure comprising a tubular body portion, the proximal head configured to be disposed within the tubular body portion and the distal tissue coupling element configured to be anchored within tissue of the native heart valve annulus.

61. 59. The system of claim 57 or 58, wherein the annulus marking device is coupled to the distal tissue coupling element.

62. 62. The system of claim 61, wherein the annulus marking device is coupled to a distal end of the distal tissue coupling element.

63. 62. The system of claim 61, further comprising an annuloplasty structure comprising a fabric, the annulus marking device being configured to pass through the fabric of the annuloplasty structure.

64. 64. The system of any one of claims 57 to 63, wherein the annulus marking device comprises one or more radiopaque filaments configured to mark the native heart valve annulus and tissue associated therewith.

65. 65. The system of claim 64, wherein each of the one or more radiopaque filaments comprises a flexible material.

66. a tissue anchor including a distal tissue coupling element in tissue of a native heart valve annulus, the distal tissue coupling element having a longitudinal axis measured from a distal end to a proximal end of the distal tissue coupling element, the distal tissue coupling element configured to anchor into tissue of the native heart valve annulus; and marking a location of a subject's native heart annulus by implanting an annulus marking device coupled to the tissue anchor, the annulus marking device comprising a radiopaque material and configured to protrude away from a longitudinal axis of the distal tissue coupling element; imaging the location and viewing the annulus marking device against tissue of the native heart valve annulus during imaging; The method includes:

67. 67. The method of claim 66, wherein imaging the location comprises imaging using fluoroscopy.

68. 68. The method of claim 66 or 67, wherein marking the location comprises marking the location along a mitral valve annulus.

69. 68. The method of claim 66 or 67, wherein marking the location comprises marking the location along an annulus of a tricuspid valve.

70. 70. The method of any one of claims 66 to 69, wherein the method further comprises viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

71. 71. The method of claim 70, wherein viewing the tissue of the native heart annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

72. 72. The method of claim 71, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

73. 71. The method of claim 70, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

74. 74. The method of any one of claims 66 to 73, wherein the tissue anchor includes a proximal head coupled to a proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

75. 75. The method of claim 74, wherein the method further comprises the step of implanting an annuloplasty structure including a tubular body portion along the native heart valve annulus, and wherein implanting the tissue anchor comprises the step of positioning the proximal head within the tubular body portion while implanting the distal tissue coupling element into tissue of the native heart valve annulus.

76. 76. The method of any one of claims 66 to 75, wherein the annulus marking device is coupled to the distal tissue coupling element.

77. 77. The method of claim 76, wherein the annulus marking device is coupled to the distal end of the distal tissue coupling element.

78. 77. The method of claim 76, wherein the method further comprises implanting an annuloplasty structure including a fabric along the native heart annulus, and wherein implanting the tissue anchor comprises threading the annulus marking device through the fabric of the annuloplasty structure.

79. 80. The method of claim 78, wherein the step of threading the annulus marking device through a fabric of an annuloplasty structure comprises the step of threading the annulus marking device through a fabric of a portion of the annuloplasty structure before a portion of the annuloplasty structure is positioned along the native heart annulus, the method further comprising the step of imaging the native heart annulus before a portion of the annuloplasty structure is positioned along the native heart annulus.

80. 80. The method of any one of claims 66 to 79, wherein the annulus marking device comprises one or more radiopaque filaments configured to mark the native heart valve annulus and tissue associated therewith.

81. 81. The method of claim 80, wherein each of the one or more radiopaque filaments comprises a flexible material.

82. 1. An apparatus for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus, the implant comprising a body portion including a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device including one or more planar radiopaque fins extending along at least a portion of the body portion and projecting away from the longitudinal axis; wherein each of the one or more planar radiopaque fins has a longest dimension measured along the longitudinal axis.

83. 83. The apparatus of claim 82, wherein the body portion comprises a plurality of radiopaque markings at respective locations along the body portion.

84. 84. The apparatus of claim 82 or 83, wherein the one or more planar radiopaque fins comprise a flexible fabric.

85. 85. The apparatus of any one of claims 82 to 84, wherein the one or more planar radiopaque fins comprise two or more planar radiopaque fins.

86. 86. The apparatus of claim 85, further comprising at least one tissue anchor deployable through a body portion of the implant and between the two or more planar radiopaque fins.

87. Placing an implant at a subject's native heart valve annulus, the implant being configured to be positioned along the native heart valve annulus, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device including one or more planar radiopaque fins extending along at least a portion of the body portion and projecting away from a longitudinal axis, each of the one or more planar radiopaque fins having a longest dimension measured along the longitudinal axis; deploying, under imaging, at least one tissue anchor through a body portion of the implant and into tissue of the native heart valve annulus using the annulus marking device as a guide; The method includes:

88. 90. The method of claim 87, wherein the step of deploying under imaging comprises imaging using fluoroscopy.

89. 90. The method of claim 87 or 88, wherein the step of placing comprises placing the implant along an annulus of a mitral valve.

90. 90. The method of claim 87 or 88, wherein the step of placing comprises placing the implant along an annulus of a tricuspid valve.

91. 91. The method of any one of claims 87 to 90, wherein the body portion includes a plurality of radiopaque markings at respective locations along the body portion, and deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors in accordance with the respective radiopaque markings.

92. 92. The method of any one of claims 87 to 91, wherein the one or more planar radiopaque fins are flexible and comprise fabric.

93. 93. The method of any one of claims 87 to 92, wherein the one or more planar radiopaque fins comprises two or more planar radiopaque fins.

94. 94. The method of claim 93, wherein deploying at least one tissue anchor through a body portion of the implant comprises deploying the at least one tissue anchor through a body portion of the implant and between the two or more planar radiopaque fins.

95. 95. The method of any one of claims 87 to 94, further comprising the step of viewing tissue of a native heart valve annulus and tissue associated therewith under imaging of the one or more planar radiopaque fins.

96. 96. The method of claim 95, wherein viewing the tissue of the native heart valve annulus and associated tissue comprises imaging the one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and associated tissue by viewing the one or more planar radiopaque fins relative to the tissue.

97. 96. The method of claim 95, wherein viewing the tissue of the native heart valve annulus comprises imaging the one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the one or more planar radiopaque fins in response to movement of the tissue.

98. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject, the implant comprising a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; wherein the annulus marking device comprises: a scaffold comprising a radiopaque material, the scaffold being foldable and expandable and configured to extend along at least one side of a body portion of the implant when expanded; a plurality of radiopaque filaments coupled to the scaffold at least at a distal end thereof and configured to mark the native heart valve annulus and tissue coupled thereto; A system comprising:

99. 100. The system of claim 98, wherein the body portion comprises a plurality of radiopaque markings at respective locations along the body portion.

100. 100. The system of claim 98 or 99, wherein each of the plurality of radiopaque filaments comprises a flexible material.

101. 101. The system of any one of claims 98-100, wherein the scaffold comprises a plurality of struts collectively arranged in a triangular shape, the scaffold being generally planar and extending along a sidewall of the body portion when the scaffold is expanded.

102. 102. The system of any one of claims 98 to 101, wherein the annulus marking device is coupled to a delivery tool configured to deliver the implant to the native heart valve annulus, and wherein the annulus marking device is retrievable upon removal of the delivery tool from the subject.

103. 103. The system of claim 102, wherein the delivery tool is configured to surround a portion of the body portion of the implant and the annulus marking device is configured to at least partially surround the body portion of the implant.

104. 103. The system of claim 102, wherein the delivery tool comprises fins coupled to a distal portion of the delivery tool and a portion of the scaffold, such that movement of the fins in response to blood flow orients the scaffold relative to a body portion of the implant by rotation.

105. 105. The system of any one of claims 98-104, wherein the scaffold is coupled to a ring at a proximal end of the scaffold, the ring surrounding at least a portion of the body portion of the implant and movable proximally and distally relative to the body portion of the implant such that the scaffold is movable to multiple locations along the body portion of the implant.

106. the scaffold is shaped to partially surround a given portion of a body portion of the implant; the plurality of radiopaque filaments comprises a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length; The system of claim 105, wherein the first and second subsets are configured to rotationally orient the scaffold relative to the implant.

107. The system of claim 106, wherein the scaffold is semi-tubular.

108. The system of claim 106, wherein the scaffold is planar and generally triangular.

109. The system of claim 106, wherein the scaffold is frustoconical.

110. the scaffold is shaped to partially surround a given portion of a body portion of the implant; the plurality of radiopaque filaments comprises a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness; The system of claim 105, wherein the first and second subsets are configured to rotationally orient the scaffold relative to the implant.

111. The system of claim 110, wherein the scaffold is semi-tubular.

112. The system of claim 110, wherein the scaffold is planar and generally triangular.

113. The system of claim 110, wherein the scaffold is frustoconical.

114. 114. The system of any one of claims 98-113, wherein the scaffolding comprises a plurality of struts collectively arranged in a frusto-conical shape, the scaffolding surrounding at least a portion of a body portion of the implant.

115. 115. The system of claim 114, wherein the scaffold is movable proximally and distally relative to the body portion of the implant such that the scaffold is movable to multiple locations along the body portion of the implant.

116. placing an implant at a subject's native heart valve annulus, the implant including a body portion including a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; viewing the placement under imaging by imaging the annulus marking device; wherein the annulus marking device comprises: a scaffold comprising a radiopaque material, the scaffold being foldable and expandable and configured to extend along at least one side of a body portion of the implant when expanded; a plurality of radiopaque filaments coupled to the scaffold at least at a distal end thereof and configured to mark the native heart valve annulus and tissue coupled thereto; A method comprising:

117. 117. The method of claim 116, wherein the step of viewing the placement further comprises the steps of imaging a plurality of radiopaque markings on the body portion of the implant, and deploying an anchor along the body portion in response to imaging the plurality of radiopaque markings on the body portion of the implant.

118. 118. The method of claim 116 or 117, wherein each of the plurality of radiopaque filaments comprises a flexible material.

119. the scaffold comprises a plurality of struts collectively arranged in a triangular shape; the scaffold is generally planar and extends along a sidewall of the body portion when the scaffold is expanded; 119. The method of any one of claims 116 to 118, wherein imaging the annulus marking device comprises imaging a triangular shape of the scaffolding material relative to the tissue and a body portion of the implant.

120. 120. The method of any one of claims 116 to 119, wherein the step of placing the implant comprises delivering the implant using a delivery tool coupled to the annulus marking device, the method further comprising the step of retrieving the annulus marking device during removal of the delivery tool from the subject.

121. 121. The method of claim 120, wherein the delivery tool is configured to surround a portion of the body portion of the implant and the annulus marking device is configured to at least partially surround the body portion of the implant.

122. 121. The method of claim 120, wherein the delivery tool includes a fin coupled to a distal portion of the delivery tool and a portion of the scaffold, the method further comprising orienting the scaffold relative to a body portion of the implant by rotation in response to movement of the fin in response to blood flow.

123. 123. The method of any one of claims 116-122, wherein the scaffold is coupled to a ring at a proximal end of the scaffold, the ring surrounding at least a portion of the body portion of the implant and movable proximally and distally relative to the body portion of the implant, the method further comprising facilitating movement of the scaffold to multiple locations along the body portion of the implant.

124. the scaffold is shaped to partially surround a given portion of a body portion of the implant; the plurality of radiopaque filaments includes a first subset of radiopaque filaments having a first length and a second subset of filaments having a second length greater than the first length; 124. The method of claim 123, the method further comprising using the first and second subsets to rotationally orient the scaffold relative to the implant.

125. 125. The method of claim 124, wherein the scaffold is semi-tubular.

126. 125. The method of claim 124, wherein the scaffold is planar and generally triangular.

127. 125. The method of claim 124, wherein the scaffold is frustoconical.

128. the scaffold is shaped to partially surround a given portion of the body portion of the implant; the plurality of radiopaque filaments comprises a first subset of radiopaque filaments having a first stiffness and a second subset of filaments having a second stiffness greater than the first stiffness; 124. The method of claim 123, the method further comprising using the first and second subsets to rotationally orient the scaffold relative to the implant.

129. 129. The method of claim 128, wherein the scaffold is semi-tubular.

130. 129. The method of claim 128, wherein the scaffold is planar and generally triangular.

131. The method of claim 128, wherein the scaffold is frustoconical.

132. 132. The method of any one of claims 116-131, wherein the scaffolding comprises a plurality of struts collectively arranged in a frusto-conical shape, the scaffolding surrounding at least a portion of a body portion of the implant.

133. 133. The method of claim 132, wherein the scaffold is movable proximally and distally relative to a body portion of the implant, the method further comprising facilitating movement of the scaffold to multiple locations along a body portion of the implant.

134. 1. A system for use with a subject, comprising:

1. A valve annulus marking device comprising a radiopaque material, (1) a tubular stent body having a central longitudinal axis and configured to be positioned within the subject's native heart valve; and (2) a tubular stent body is coupled to a proximal end thereof and configured to define a plurality of extensions projecting away from a longitudinal axis of the tubular stent body, the plurality of extensions being configured to be positioned circumferentially about an annulus of the native heart valve, the annulus marking device comprising: compressible during delivery to the native heart valve; a valve annulus marking device expandable from a compressed state for positioning within the native heart valve; an implant for implantation along an annulus of a valve of the subject; Equipped with The annulus marking device comprises: configured to provide a guide for placing the implant along the valve annulus during implantation; The system is retrievable after implantation of the implant.

135. 135. The system of claim 134, wherein the annulus marking device comprises a superelastic material.

136. 136. The system of claim 134 or 135, wherein the tubular stent body and the multiple extensions are fabricated from a single piece.

137. 135. The system of claim 134, wherein the tubular stent body comprises two or more prosthetic leaflets.

138. 135. The system of claim 134, further comprising a plurality of anchors, each anchor of the plurality of anchors configured to anchor the implant to an annulus of a native valve.

139. Placing an annulus marking device comprising a radiopaque material on a subject's native heart valve, the annulus marking device comprising: (1) a tubular stent body having a central longitudinal axis and configured to be positioned within the subject's native heart valve; and (2) a tubular stent body is coupled to a proximal end thereof and configured to define a plurality of extensions projecting away from a longitudinal axis of the tubular stent body, the plurality of extensions being configured to be positioned circumferentially about an annulus of the native heart valve, the annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within the native heart valve; implanting the implant along the valve annulus using the annulus marking device as a guide for implanting the implant along the valve annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

140. 140. The method of claim 139, wherein implanting under imaging comprises implanting using fluoroscopy.

141. 141. The method of claim 139 or 140, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device in a tool and extracting the annulus marking device from the subject.

142. 142. The method of any one of claims 139 to 141, wherein the placing step comprises placing the annulus marking device in a mitral valve.

143. 142. The method of any one of claims 139 to 141, wherein the placing step comprises placing the annulus marking device in a tricuspid valve.

144. 144. The method of any one of claims 139 to 143, wherein the step of implanting the implant includes the step of anchoring the implant to an annulus of a native valve by deploying each anchor of a plurality of anchors between adjacent extensions of the plurality of extensions.

145. 140. The method of claim 139, wherein retrieving the annulus marking device after implantation comprises sliding the plurality of extensions out from under the implant.

146. 140. The method of claim 139, wherein the method further comprises using the plurality of extensions to view tissue of a native heart valve annulus and tissue associated therewith.

147. 147. The method of claim 146, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of extensions relative to the tissue.

148. 147. The method of claim 146, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing movement of the plurality of extensions in response to movement of the tissue.

149. placing an annulus marking device comprising a mapping catheter at a native heart valve annulus of a subject; generating a map of the native heart valve annulus under imaging using the mapping catheter; implanting an implant into the native heart valve annulus under imaging in response to generating the map; The method includes:

150. 150. The method of claim 149, wherein implanting under imaging comprises implanting using fluoroscopy.

151. 151. The method of claim 149 or 150, further comprising the steps of retrieving the annulus marking device after generating the map and then extracting the annulus marking device from the subject.

152. 152. The method of any one of claims 149 to 151, wherein the placing step comprises placing the annulus marking device along the annulus of a mitral valve.

153. 152. The method of any one of claims 149 to 151, wherein the placing step comprises placing the annulus marking device along the annulus of a tricuspid valve.

154. 154. The method of any one of claims 149 to 153, wherein the mapping catheter comprises a radiopaque material and generating the map comprises imaging the mapping catheter under fluoroscopy.

155. 155. The method of any one of claims 149 to 154, wherein the mapping catheter comprises a magnetic subunit, and generating the map comprises generating a magnetic field and mapping the valve under magnetic imaging.

156. 156. The method of any one of claims 149 to 155, wherein the mapping catheter comprises electrodes and generating the map comprises generating the map using the electrodes.

157. 157. The method of any one of claims 149 to 156, further comprising the step of retrieving the mapping catheter.

158. 158. The method of claim 157, wherein the step of retrieving the mapping catheter comprises the step of retrieving the mapping catheter prior to implantation, and the step of implanting comprises the step of implanting under guidance of a map generated by the mapping catheter.

159. 158. The method of claim 157, wherein retrieving the mapping catheter comprises retrieving the mapping catheter after implantation.

160. 160. The method of any one of claims 149 to 159, the method further comprising using the mapping catheter to view tissue of the native heart valve annulus and tissue associated therewith.

161. 161. The method of claim 160, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the mapping catheter relative to the tissue.

162. The method of claim 160, wherein viewing the tissue of the native heart valve annulus and associated tissue comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and associated tissue by viewing movement of the mapping catheter in response to movement of the tissue.

163. placing an annulus marking device comprising a radiopaque material within at least an atrium of a subject's heart, said annulus marking device shaped to define a plurality of expandable elements that radially expand within the atrium, such that said plurality of expandable elements provide an indication of a location of a native heart annulus of a native heart valve of the subject, said annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within at least the atrium; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

164. 164. The method of claim 163, wherein the step of implanting under imaging comprises the step of implanting using fluoroscopy.

165. 165. The method of claim 163 or 164, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device in a tool and extracting the annulus marking device from the subject.

166. 166. The method of any one of claims 163 to 165, wherein the placing step includes placing the annulus marking device in the left atrium.

167. 166. The method of any one of claims 163 to 165, wherein the placing step includes placing the annulus marking device in the right atrium.

168. The method of any one of claims 163 to 167, wherein the plurality of expandable elements collectively form the annulus marking device into a generally spherical shape, and implanting the implant includes positioning the implant between the annulus marking device and tissue of an atrial wall.

169. 169. The method of claim 168, wherein the plurality of expandable elements comprises a plurality of woven radiopaque fibers in a mesh.

170. 169. The method of claim 168, wherein the plurality of expandable elements comprises a plurality of curved wires.

171. 171. The method of claim 170, wherein the step of implanting the implant comprises the steps of positioning the implant between the annulus marking device and tissue of an atrial wall, and deploying tissue anchors at marked sites between successive curved wires along the annulus.

172. 172. The method of claim 171, wherein each of the plurality of bowing wires has a proximal end and a distal end and an intermediate section between the proximal and distal ends.

173. 173. The method of claim 172, wherein a collective proximal diameter of the proximal ends of the plurality of expandable elements is equal to a collective distal diameter of the distal ends of the plurality of expandable elements, and a collective intermediate diameter of the plurality of expandable elements is greater than the collective proximal diameter and greater than the collective distal diameter.

174. 174. The method of any one of claims 163 to 173, wherein the plurality of expandable elements collectively form the annulus marking device into a partially spherical shape, and implanting an implant comprises positioning the implant between the annulus marking device and tissue of an atrial wall, and deploying tissue anchors at marked sites between successive expandable elements along the annulus.

175. 175. The method of claim 174, wherein the plurality of expandable elements comprises a plurality of struts that collectively form a partially spherical stent.

176. 176. The method of claim 175, wherein the partially spherical stent comprises a plurality of radiopaque filaments coupled to a distal end of the partially spherical stent, the method further comprising the step of using the plurality of radiopaque filaments to view tissue of the native heart valve annulus and tissue coupled thereto.

177. 177. The method of claim 176, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

178. 178. The method of claim 177, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

179. 177. The method of claim 176, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

180. 175. The method of claim 174, wherein the plurality of expandable elements comprises a plurality of curved wires.

181. 181. The method of claim 180, wherein the step of positioning the annulus marking device comprises the step of expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

182. 181. The method of claim 180, wherein the step of positioning the annulus marking device comprises the step of expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within a ventricle of the heart.

183. 183. The method of any one of claims 163 to 182, wherein the plurality of expandable elements collectively form the annulus marking device in a partially bulbous shape, and implanting the implant comprises positioning the implant between the annulus marking device and tissue of an atrial wall, and deploying tissue anchors at marked sites between successive expandable elements along the annulus.

184. 184. The method of claim 183, further comprising the step of delivering a radiopaque helical stent between the plurality of expandable elements.

185. 185. The method of claim 184, wherein the step of delivering the helical stent comprises the step of delivering the helical stent between the native leaflets of the native heart valve.

186. 186. The method of claim 185, wherein the step of delivering a helical stent between the native leaflets of the native heart valve comprises the step of positioning a distal end of the helical stent within a chamber of the heart of the subject.

187. 184. The method of claim 183, wherein the plurality of expandable elements comprises a plurality of bowing wires, each of the plurality of bowing wires having a proximal end and a distal end and an intermediate section between the proximal end and the distal end.

188. 188. The method of claim 187, wherein a collective proximal diameter of the proximal ends of the plurality of expandable elements is smaller than a collective distal diameter of the distal ends of the plurality of expandable elements, and a collective intermediate diameter of the plurality of expandable elements is larger than the collective proximal diameter and larger than the collective distal diameter.

189. 188. The method of claim 187, wherein the step of positioning the annulus marking device comprises the step of expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

190. 188. The method of claim 187, wherein the step of positioning the annulus marking device comprises the step of expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within a ventricle of the heart.

191. 191. The method of any one of claims 163 to 190, the method further comprising the step of viewing tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements.

192. The method of claim 191, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements relative to the tissue.

193. 200. The method of claim 192, wherein viewing the plurality of expandable elements comprises viewing movement of the plurality of expandable elements in response to movement of the tissue.

194. 192. The method of claim 191, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging a plurality of expandable elements relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

195. 195. The method of any one of claims 163 to 194, wherein the annulus marking device comprises a plurality of radiopaque filaments coupled at least to a distal end of the annulus marking device, the method further comprising the step of using the plurality of radiopaque filaments to view tissue of the native heart annulus and tissue coupled thereto.

196. 200. The method of claim 195, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

197. 200. The method of claim 196, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

198. 200. The method of claim 195, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

199. 1. A system for use with a subject, comprising:

1. A valve annulus marking device comprising a radiopaque material, (1) a tubular stent body having a central longitudinal axis and configured to be positioned within the subject's native heart valve; and (2) a tubular stent body is coupled to a proximal end thereof and configured to define a frame projecting away from a longitudinal axis of the tubular stent body, the frame being configured to be positioned along at least a portion of a circumference of an annulus of the native heart valve, the annulus marking device comprising: compressible during delivery to the native heart valve; a valve annulus marking device expandable from a compressed state for positioning within the native heart valve; an implant for implantation along an annulus of a valve of the subject; Equipped with The annulus marking device comprises: configured to provide a guide for implanting the implant along a valve annulus within a space defined by the frame; The system is retrievable after implantation of the implant.

200. 200. The system of claim 199, wherein the annulus marking device comprises a superelastic material.

201. 201. The system of claim 199 or 200, wherein the tubular stent body and the frame are fabricated from a single piece.

202. The system of claim 199 or 200, wherein the tubular stent body comprises two or more prosthetic leaflets.

203. Placing an annulus marking device comprising a radiopaque material on a subject's native heart valve, the annulus marking device comprising: (1) a tubular stent body having a central longitudinal axis and configured to be positioned within the subject's native heart valve; and (2) a tubular stent body is coupled to a proximal end thereof and configured to define a frame projecting away from a longitudinal axis of the tubular stent body, the frame being configured to be positioned along at least a portion of a circumference of an annulus of the native heart valve, the annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within the native heart valve; implanting the implant along the annulus using the annulus marking device as a guide for implanting an implant within a space defined by the frame along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

204. 204. The method of claim 203, wherein the step of implanting under imaging includes the step of implanting using fluoroscopy.

205. The method of claim 203 or 204, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device in a tool and extracting the annulus marking device from the subject.

206. 206. The method of any one of claims 203 to 205, wherein the placing step includes placing the annulus marking device in a mitral valve.

207. 206. The method of any one of claims 203 to 205, wherein the placing step includes placing the annulus marking device in a tricuspid valve.

208. 208. The method of any one of claims 203 to 207, wherein retrieving the annulus marking device after implantation comprises sliding the frame proximally around the implant and away from the annulus.

209. 209. The method of any one of claims 203 to 208, the method further comprising using the frame to view tissue of a native heart valve annulus and tissue associated therewith.

210. The method of claim 209, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the frame against the tissue.

211. 211. The method of claim 210, wherein viewing the frame comprises viewing movement of the frame in response to movement of the tissue.

212. placing an annulus marking device comprising a radiopaque material within at least an atrium of a heart of a subject, said annulus marking device shaped to define a plurality of expandable elements including respective curved sections at a distal end thereof, said plurality of expandable elements configured to expand radially within said atrium, such that said plurality of expandable elements provide an indication as to a location of a native heart annulus of a native heart valve of said subject, said annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within at least the atrium; implanting the implant within a concave section of each of the plurality of expandable elements along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

213. 213. The method of claim 212, wherein the step of positioning the annulus marking device comprises the step of positioning the annulus marking device when the implant is positioned within a concave section of the plurality of expandable elements.

214. 214. The method of claim 212 or 213, wherein implanting the implant comprises positioning the implant within a concave section of the plurality of expandable elements after placement of the annulus marking device.

215. 215. The method of any one of claims 212 to 214, wherein implanting under imaging comprises implanting using fluoroscopy.

216. The method of any one of claims 212 to 215, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

217. 217. The method of any one of claims 212 to 216, wherein retrieving the annulus marking device after implantation comprises sliding the curved sections of the plurality of expandable elements out from under the implant.

218. 218. The method of any one of claims 212 to 217, wherein the placing step includes placing the annulus marking device in the left atrium.

219. 218. The method of any one of claims 212 to 217, wherein the placing step includes placing the annulus marking device in the right atrium.

220. 220. The method of any one of claims 212 to 219, wherein the step of positioning the annulus marking device comprises the step of expanding the annulus marking device such that a distal end of each of the plurality of expandable elements is positioned within the atrium.

221. 221. The method of any one of claims 212 to 220, wherein the plurality of expandable elements collectively form the annulus marking device into a partially pear-shaped shape, and implanting the implant includes deploying tissue anchors at marked sites between successive expandable elements along the annulus.

222. 221. The method of any one of claims 212 to 220, wherein the plurality of expandable elements collectively form the annulus marking device into a partially bulbous shape, and implanting the implant includes deploying tissue anchors at marked sites between successive expandable elements along the annulus.

223. 223. The method of claim 222, wherein the plurality of expandable elements comprises a plurality of bowing wires, each of the plurality of bowing wires having a proximal end and a distal end and an intermediate section between the proximal end and the distal end.

224. 224. The method of claim 223, wherein a collective proximal diameter of the proximal ends of the plurality of expandable elements is smaller than a collective distal diameter of the distal ends of the plurality of expandable elements, and a collective intermediate diameter of the plurality of expandable elements is larger than the collective proximal diameter and larger than the collective distal diameter.

225. 225. The method of any one of claims 212 to 224, the method further comprising viewing tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements.

226. The method of claim 225, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of expandable elements relative to the tissue.

227. 227. The method of claim 226, wherein viewing the plurality of expandable elements comprises viewing movement of the plurality of expandable elements in response to movement of the tissue.

228. 226. The method of claim 225, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging a plurality of expandable elements relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

229. 229. The method of any one of claims 212 to 228, wherein the annulus marking device includes a plurality of radiopaque filaments coupled at least to a distal end of the annulus marking device, the method further comprising the step of using the plurality of radiopaque filaments to view tissue of the native heart annulus and tissue coupled thereto.

230. 230. The method of claim 229, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

231. 231. The method of claim 230, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

232. 230. The method of claim 229, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

233. placing a distal end of an annulus marking device comprising a radiopaque material on a ventricular surface of a subject's native heart valve annulus, the distal end being shaped to define a curved section that curves upwardly toward the ventricular surface; facilitating imaging of the heart valve annulus by imaging the movement of the distal end of the annulus marking device along a periphery of a ventricular surface of the native heart valve annulus; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

234. 234. The method of claim 233, wherein the step of placing a distal end of the annulus marking device on the ventricular surface comprises placing a distal end of the annulus marking device on the ventricular surface of a native mitral valve.

235. 234. The method of claim 233, wherein the step of placing the distal end of the annulus marking device on the ventricular surface comprises the step of placing the distal end of the annulus marking device on the ventricular surface of a native tricuspid valve.

236. 236. The method of any one of claims 233 to 235, wherein the step of implanting includes the step of implanting in conjunction with imaging of the movement of the distal end of the annulus marking device.

237. The method of any one of claims 233 to 236, further comprising the step of generating a map of the native heart valve annulus by imaging the movement of the distal end of the annulus marking device along the periphery of the ventricular surface of the native heart valve annulus.

238. 238. The method of any one of claims 233 to 237, wherein generating a map comprises generating the map prior to implantation.

239. placing an annulus marking device comprising an annular stent comprising a radiopaque material on a surface of a subject's native heart valve annulus; facilitating imaging of the native heart valve annulus by imaging the annulus marking device along a periphery of a ventricular surface of the native heart valve annulus; implanting the implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the native heart valve annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

240. 240. The method of claim 239, wherein implanting the implant comprises implanting the implant between an outer surface of the annular stent and tissue of an atrial wall.

241. 241. The method of claim 239 or 240, wherein the step of placing on a surface comprises placing the annulus marking device on an atrial surface of the native heart valve annulus.

242. 242. The method of any one of claims 239 to 241, wherein the placing step comprises placing the annulus marking device on a surface of the native mitral valve.

243. 242. The method of any one of claims 239 to 241, wherein the placing step comprises placing the annulus marking device on a surface of a native tricuspid valve.

244. 244. The method of any one of claims 239 to 243, further comprising the step of viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

245. The method of claim 244, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

246. 246. The method of claim 245, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

247. The method of claim 244, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

248. The method of any one of claims 239 to 247, wherein the annular stent includes a plurality of radiopaque filaments attached to at least an inner surface of the annular stent, the step of positioning the annular marking device includes a step of positioning the annular stent along the annulus such that at least some of the plurality of radiopaque filaments protrude toward the valve opening, and the method further includes a step of using the plurality of radiopaque filaments to view tissue of the native heart valve annulus and tissue attached thereto.

249. The method of claim 248, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

250. 250. The method of claim 249, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

251. The method of claim 248, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

252. placing an annulus marking device on a surface of a subject's native heart valve annulus, the annulus marking device comprising an implant guidance device comprising a radiopaque material; facilitating imaging of the native heart valve annulus by imaging movement of the implant guide device circumferentially along a surface of the native heart valve annulus; implanting the implant along the subject's native heart valve annulus using the implant guidance device as a guide for implanting the implant along the native heart valve annulus under imaging in conjunction with the positioning; retrieving the annulus marking device after implantation; and The method includes:

253. 253. The method of claim 252, wherein the step of positioning the annulus marking device comprises the step of advancing the annulus marking device along an implantation pathway upstream of the implant.

254. 254. The method of claim 252 or 253, wherein the placing step includes placing the annulus marking device on a surface of the native mitral valve.

255. 254. The method of any one of claims 252 or 253, wherein the placing step comprises placing the annulus marking device on a surface of a native tricuspid valve.

256. 256. The method of any one of claims 252 to 255, wherein the step of positioning includes a step of positioning the annulus marking device such that a portion of the annulus marking device spans a portion of the valve opening.

257. 257. The method of any one of claims 252 to 256, further comprising the step of viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

258. The method of claim 257, wherein viewing the tissue of the native heart annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

259. The method of claim 258, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

260. The method of claim 257, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

261. 261. The method of any one of claims 252 to 260, wherein the implant guide device comprises a plurality of radiopaque filaments coupled to the implant guide device, the method further comprising the step of using the plurality of radiopaque filaments to view tissue of the native heart valve annulus and tissue coupled thereto.

262. The method of claim 261, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

263. 263. The method of claim 262, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

264. The method of claim 261, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

265. placing an annulus marking device comprising a looped wire comprising a radiopaque material on a surface of a native heart valve annulus of a subject; facilitating imaging of the native heart valve annulus by imaging the movement of the looped wire along at least a portion of a circumference of a surface of the native heart valve annulus; implanting the implant along the subject's native heart valve annulus using the looped wire as a guide for implanting the implant along the native heart valve annulus under imaging in conjunction with the positioning; retrieving the annulus marking device after implantation; and The method includes:

266. 266. The method of claim 265, wherein the step of implanting under imaging includes the step of implanting using fluoroscopy.

267. 267. The method of claim 265 or 266, wherein the step of positioning the annulus marking device comprises the step of advancing the annulus marking device along an implantation pathway upstream of the implant.

268. The method of claim 265 or 266, wherein the placing step includes placing the annulus marking device on a surface of the native mitral valve.

269. The method of claim 265 or 266, wherein the placing step includes placing the annulus marking device on a surface of the native tricuspid valve.

270. A method according to any one of claims 265 to 269, wherein the placing step comprises pressing a first portion of the annulus marking device against a first portion of the valve annulus, thereby pressing a second portion of the annulus marking device opposite the first portion of the annulus marking device against a second portion of the valve annulus.

271. 271. The method of claim 270, wherein implanting the implant comprises implanting the implant around an outer periphery of the annulus marking device in response to the pressing force.

272. 272. The method of any one of claims 265 to 271, further comprising the step of viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

273. The method of claim 272, wherein viewing the tissue of the native heart annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

274. 274. The method of claim 273, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

275. 273. The method of claim 272, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

276. 276. The method of any one of claims 265 to 275, wherein the annulus marking device comprises a plurality of radiopaque filaments coupled to the annulus marking device, the method further comprising the step of using the plurality of radiopaque filaments to view tissue of the native heart annulus and tissue coupled thereto.

277. 277. The method of claim 276, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

278. 278. The method of claim 277, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

279. 277. The method of claim 276, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

280. deploying within tissue of a subject's native heart valve annulus a valve annulus marking device comprising a plurality of radiopaque pins comprising a radiopaque material; facilitating imaging of the native heart valve annulus by imaging the plurality of pins; then implanting the implant along the subject's native heart valve annulus using the plurality of pins as a guide for implanting the implant along the native heart valve annulus under imaging; The method includes:

281. 281. The method of claim 280, wherein each of the plurality of pins has a barb configured to anchor to tissue of the valve annulus.

282. 282. The method of claim 280 or 281, wherein each of the plurality of pins has a longest width of 0.5 to 3.0 mm.

283. 283. The method of any one of claims 280 to 282, wherein facilitating imaging of the heart valve annulus by imaging the plurality of pins includes facilitating imaging movement of the plurality of pins in response to movement of the heart valve annulus.

284. 284. The method of any one of claims 280 to 283, wherein the step of implanting the implant comprises the step of deploying a plurality of tissue anchors to fasten the implant to tissue of the valve annulus.

285. 285. The method of claim 284, wherein deploying the plurality of tissue anchors comprises deploying a number of tissue anchors greater than the number of pins.

286. positioning an annulus marking device in tissue of a native heart valve of a subject native heart valve, the annulus marking device including a plurality of radiopaque pins that, when positioned relative to the tissue, are movable proximally and distally in response to variations in the tissue topography of the native heart valve; moving the plurality of pins along the native heart valve and imaging the plurality of pins to generate an image of a topography of the native heart valve, thereby facilitating imaging of the native heart valve annulus and tissue associated therewith; implanting the implant along the subject's native heart valve annulus using the image as a guide for implanting the implant along the native heart valve annulus under imaging; retrieving the plurality of radiopaque pins from the object; The method includes:

287. The method of claim 286, wherein the recovering step comprises recovering after transplantation.

288. 288. The method of claim 286 or 287, wherein the harvesting step comprises harvesting prior to transplantation.

289. The method of any one of claims 286 to 288, wherein the step of facilitating imaging of the heart valve annulus by imaging the plurality of pins includes the step of facilitating imaging movement of the plurality of pins in response to movement of the heart valve annulus.

290. 290. The method of any one of claims 286 to 289, wherein the implanting step comprises implanting while facilitating said imaging.

291. 291. The method of any one of claims 286 to 290, wherein the step of facilitating imaging includes the step of viewing proximal movement of the plurality of pins in response to movement of the plurality of pins over a peak of tissue in the annulus.

292. 292. The method of any one of claims 286 to 291, wherein the step of facilitating imaging includes the steps of viewing proximal movement of at least a first portion of the plurality of pins in response to movement of the plurality of pins over tissue of an annulus, and viewing at least a second portion of the plurality of pins not moving in response to movement of the plurality of pins over tissue of an atrial wall.

293. 1. A system for use with a subject, comprising: A multi-lumen tube; at least a first annulus marking device expandable from within the multi-lumen tube, a distal frame wire having an expanded shape and assuming a generally linear configuration when the annulus marking device is in an expanded state; a plurality of radiopaque filaments coupled to the distal frame wire, the filaments comprising a radiopaque material and projecting away from the distal frame wire in an expanded state of the annulus marking device; at least one central rod coupled to an intermediate portion of the distal frame wire, disposed primarily within and slidable within a primary minor lumen of the multi-lumen tube, configured to restrain the distal frame wire and the plurality of radiopaque filaments from an expanded state of the annulus marking device and to pull the distal frame wire and the plurality of radiopaque filaments within a primary minor lumen of the multi-lumen tube; at least two peripheral wires coupled to the distal frame wire at opposite ends thereof, disposed primarily within and slidable within respective secondary minor lumens of the multi-lumen tube, and configured to stabilize the distal frame wire in an expanded state of the annulus marking device; compressible during delivery to the native heart valve; expandable from a compressed state for positioning along the native heart valve annulus; a valve annulus marking device; an implant for implantation along the subject's native heart valve annulus; Equipped with The annulus marking device comprises: configured to provide a guide for implanting the implant along the native heart valve annulus during implantation; The system is retrievable after implantation of the implant.

294. 294. The system of claim 293, wherein the multi-lumen tube is shaped to define a central lumen, and the implant is configured to be delivered to the native heart valve annulus via the central lumen.

295. 295. The system of claim 293 or 294, wherein the peripheral wires are configured to follow behind the distal frame wire when the central rod pulls the distal frame wire and the plurality of radiopaque filaments within a primary secondary lumen of the multi-lumen tube.

296. 296. The system of any one of claims 293 to 295, wherein each of the plurality of radiopaque filaments and the distal frame wire comprises a flexible material.

297. the at least first annulus marking device comprises at least a first annulus marking device and a second annulus marking device; the multi-lumen tube is configured to define a first primary minor lumen and a second primary minor lumen; the multi-lumen tube is configured to define four secondary sub-lumens; the system comprising a first central rod and a second central rod configured to constrain the first and second annular marking devices within respective first and second primary minor lumens, The system of any one of claims 293 to 296, wherein the system comprises four peripheral wires configured to stabilize distal frame wires of the respective first and second annular marking devices, the four peripheral wires being slidable within the four secondary accessory lumens.

298. 300. The system of claim 297, wherein the first and second annular marking devices are independently controllable by respective first and second control rods.

299. the at least first annulus marking device comprises a first annulus marking device, a second annulus marking device, a third annulus marking device, and a fourth annulus marking device; the multi-lumen tube is configured to define a first primary minor lumen, a second primary minor lumen, a third primary minor lumen, and a fourth primary minor lumen; the multi-lumen tube is configured to define eight secondary sub-lumens; the system comprising a first central rod, a second central rod, a third central rod, and a fourth central rod configured to constrain the first annulus marking device, the second annulus marking device, the third annulus marking device, and the fourth annulus marking device within their respective first primary minor lumen, second primary minor lumen, third primary minor lumen, and fourth primary minor lumen, respectively; The system of claim 297, wherein the system comprises eight peripheral wires configured to stabilize distal frame wires of the respective first annular marking device, second annular marking device, third annular marking device, and fourth annular marking device, and the eight peripheral wires are slidable within the eight secondary minor lumens.

300. The system of claim 299, wherein the first annulus marking device, the second annulus marking device, the third annulus marking device, and the fourth annulus marking device are independently controllable by respective first control rod, second control rod, third control rod, and fourth control rod.

301. delivering a distal end of a central multi-lumen tube within a lumen of a subject's endoscopic image; Expanding at least a first annulus marking device from within the multi-lumen tube, the first annulus marking device comprising: a distal frame wire having an expanded shape and assuming a generally linear configuration when the annulus marking device is in an expanded state; a plurality of radiopaque filaments coupled to the distal frame wire, the filaments comprising a radiopaque material and projecting away from the distal wire in an expanded state of the annulus marking device; controlling a position of the at least first annulus marking device by sliding at least one central rod coupled to an intermediate portion of the distal frame wire through a primary minor lumen of the multi-lumen tube and disposed primarily within a primary minor lumen of the multi-lumen tube; stabilizing the distal frame wire with at least two peripheral wires coupled to the distal frame wire at both ends thereof, the at least two peripheral wires being primarily disposed within and slidable within respective secondary minor lumens of the multi-lumen tube and configured to stabilize the distal frame wire in an expanded state of the annulus marking device; constraining the annulus marking device by pulling on the central rod to constrain the distal frame wire and the plurality of radiopaque filaments from an expanded state of the annulus marking device, and pulling the distal frame wire and the plurality of radiopaque filaments within a primary minor lumen of the multi-lumen tube by pulling; The annulus marking device comprises: compressible during delivery to the native heart valve; expandable from a compressed state for positioning along a native heart valve annulus; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

302. 302. The method of claim 301, wherein the multi-lumen tube is shaped to define a central lumen, the method further comprising the step of delivering the implant to the heart valve annulus via the central lumen.

303. The method of claim 301 or 302, wherein the step of constraining the annulus marking device by pulling on the central rod includes the step of allowing the peripheral wires to follow behind the distal frame wire as the central rod pulls on the distal frame wire and the plurality of radiopaque filaments within a primary secondary lumen of the multi-lumen tube.

304. 304. The method of any one of claims 301 to 303, wherein each of the plurality of radiopaque filaments and the distal frame wire comprises a flexible material.

305. The method of any one of claims 301 to 304, wherein controlling the position of the at least first annular marking device comprises positioning the at least first annular marking device along a mitral valve annulus.

306. The method of any one of claims 301 to 304, wherein controlling the position of the at least first annular marking device comprises positioning the at least first annular marking device along a tricuspid valve annulus.

307. the at least first annulus marking device includes at least a first annulus marking device and a second annulus marking device; the multi-lumen tube is configured to define a first primary minor lumen and a second primary minor lumen; the multi-lumen tube is configured to define four secondary sub-lumens; the method further comprising the step of constraining the first and second annulus marking devices within the respective first and second primary minor lumens by pulling the respective first and second control rods; The method of any one of claims 301 to 306, further comprising stabilizing the wires of the respective first and second annular marking devices using four peripheral wires slidable within the four secondary minor lumens.

308. 308. The method of claim 307, further comprising the step of independently controlling the first and second annular marking devices using the respective first and second control rods.

309. the at least first annulus marking device comprises a first annulus marking device, a second annulus marking device, a third annulus marking device, and a fourth annulus marking device; the multi-lumen tube is configured to define a first primary minor lumen, a second primary minor lumen, a third primary minor lumen, and a fourth primary minor lumen; the multi-lumen tube is configured to define eight secondary sub-lumens; the method further comprising the step of constraining the first, second, third, and fourth annulus marking devices within the second, third, and fourth primary minor lumens, respectively, by pulling the respective first, second, third, and fourth control rods; 308. The method of claim 307, further comprising stabilizing distal frame wires of the second annulus marking device, the third annulus marking device, and the fourth annulus marking device, respectively, using eight peripheral wires slidable within the eight secondary minor lumens.

310. 310. The method of claim 309, further comprising the step of independently controlling the first annular marking device, the second annular marking device, the third annular marking device, and the fourth annular marking device using the respective first and second control rods.

311. 311. The method of any one of claims 301 to 310, wherein the method further comprises using the plurality of radiopaque filaments to view tissue of the native heart valve annulus and tissue associated therewith.

312. The method of claim 311, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

313. 313. The method of claim 312, wherein viewing the plurality of radiopaque filaments comprises viewing movement of the plurality of radiopaque filaments in response to movement of the tissue.

314. The method of claim 311, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

315. placing an annulus marking device including a radiopaque material at a native heart valve annulus of a subject, the annulus marking device being shaped to define a plurality of expandable fingers, the annulus marking device being in a compressed state during delivery to the native heart valve, and being expandable from the compressed state for positioning along the native heart valve annulus; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

316. wherein positioning the annulus marking device comprises delivering the annulus marking device using a delivery tool; the annulus marking device surrounds the delivery tool; 316. The method of claim 315, wherein implanting the implant comprises delivering the implant through a lumen of the delivery tool surrounded by the annulus marking device.

317. 317. The method of claim 315 or 316, wherein positioning the annulus marking device includes measuring annulus height using the annulus marking device.

318. 318. The method of any one of claims 315 to 317, wherein the step of implanting under imaging comprises the step of implanting using fluoroscopy.

319. The method of any one of claims 315 to 318, wherein retrieving the annulus marking device after implantation comprises: contracting the annulus marking device and constraining the annulus marking device within a tool; and extracting the annulus marking device from the subject.

320. 320. The method of any one of claims 315 to 319, wherein the step of positioning the annulus marking device comprises the step of positioning the annulus marking device along a mitral valve annulus.

321. 320. The method of any one of claims 315 to 319, wherein the step of positioning the annulus marking device comprises the step of positioning the annulus marking device along an annulus of a tricuspid valve.

322. 322. The method of any one of claims 315 to 321, wherein the step of implanting an implant using the annulus marking device as a guide includes the step of viewing the shape of each of the plurality of fingers.

323. 323. The method of claim 322, wherein the step of viewing the shape includes determining that the annulus marking device is located at the annulus in response to viewing a bend in at least one of the plurality of fingers.

324. 323. The method of claim 322, wherein the step of viewing the shape includes the step of determining that the annulus marking device is located at least a portion of a valve leaflet in response to viewing movement of at least one of the plurality of fingers.

325. 325. The method of any one of claims 315 to 324, further comprising the step of expanding the plurality of fingers prior to deployment.

326. 326. The method of claim 325, wherein the expanding step includes expanding the plurality of fingers with a radiopaque fluid.

327. 327. The method of any one of claims 315 to 326, wherein the method further comprises the step of viewing tissue of the native heart valve annulus and tissue associated therewith under imaging of the plurality of fingers.

328. 328. The method of claim 327, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the plurality of fingers relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of fingers relative to the tissue.

329. 329. The method of claim 328, wherein viewing the plurality of fingers includes viewing movement of the plurality of fingers in response to movement of the tissue.

330. The method of claim 327, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

331. 1. A system for use with a subject, comprising:

1. A valve annulus marking device comprising a radiopaque material, (1) a plurality of concentric wire loops connected by a scaffold configured to be placed in an opening of a native heart valve of the subject; and (2) a scaffold is coupled to the scaffold and configured to define a concentric wire loop frame relative to the plurality of concentric wire loops, the wire loop frame being configured to be positioned along at least a portion of a circumference of an annulus of the native heart valve, the annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within the native heart valve; a valve annulus marking device; an implant for implantation along an annulus of a valve of the subject; Equipped with The annulus marking device comprises: configured to provide a guide for implanting the implant along the annulus and within a space defined by the wire loop frame; The system is retrievable after implantation of the implant.

332. The system of claim 331, wherein the annulus marking device comprises a superelastic material.

333. 333. The system of claim 331 or 332, wherein the plurality of concentric wire loops, the scaffolding, and the wire loop frame are fabricated from a single piece.

334. The system of any one of claims 331 to 333, wherein the annulus marking device comprises a plurality of radiopaque filaments at least coupled to the plurality of concentric wire loops, each of the plurality of filaments configured to oscillate in response to movement of blood through the opening of the valve to provide an indication of the location of a leaflet of the valve.

335. The system of any one of claims 331 to 334, wherein the annulus marking device comprises a locking ring within the center of a plurality of concentric wire loops, the locking ring being pressable distally using a pressing tool to lock the annulus marking device in an expanded state.

336. 336. The system of any one of claims 331 to 335, further comprising a plurality of radiopaque filaments coupled to the plurality of concentric wire loops, the plurality of radiopaque filaments comprising a radiopaque material.

337. 337. The method of claim 336, wherein the plurality of radiopaque filaments are configured to move in response to movement of the native heart valve, thereby providing an indication of the location of the valve leaflets.

338. Placing an annulus marking device comprising a radiopaque material on a subject's native heart valve, the annulus marking device comprising: (1) a plurality of concentric wire loops connected by a scaffold; and (2) a scaffold is coupled to the scaffold and configured to define a concentric wire loop frame relative to the plurality of concentric wire loops, the wire loop frame being configured to be positioned along at least a portion of a circumference of an annulus of the native heart valve, the annulus marking device comprising: compressible to a compressed state during delivery to the native heart valve; expandable from a compressed state to an expanded state for positioning within the native heart valve; implanting, under imaging, the implant along the annulus using the annulus marking device as a guide for implanting the implant within a space defined by a frame along the annulus; retrieving the annulus marking device after implantation; and The method includes:

339. The method of claim 338, further comprising the step of locking the annulus marking device in the expanded state by distally depressing a locking ring disposed within the center of the plurality of concentric wire loops.

340. The method of claim 338, further comprising the step of transitioning the annulus marking device from the compressed state to the expanded state by distally depressing a locking ring disposed within the center of the plurality of concentric wire loops.

341. 341. The method of any one of claims 338 to 340, wherein the step of implanting the implant under imaging comprises implanting using fluoroscopy.

342. The method of any one of claims 338 to 341, wherein the step of positioning the annulus marking device comprises the steps of positioning the annulus marking device on a mitral valve, positioning the plurality of concentric wire loops at an opening of the valve, and positioning the wire loop frame along at least a portion of a circumference of the mitral valve annulus.

343. The method of any one of claims 338 to 341, wherein the step of positioning the annulus marking device comprises the steps of positioning the annulus marking device in a tricuspid valve, positioning the plurality of concentric wire loops in an opening of the valve, and positioning the wire loop frame along at least a portion of the circumference of the tricuspid valve annulus.

344. The method of any one of claims 338 to 343, wherein retrieving the annulus marking device after implantation comprises sliding the frame proximally around the implant and away from the annulus.

345. 345. The method of any one of claims 338 to 344, further comprising using the annulus marking device to view tissue of the native heart annulus and tissue associated therewith.

346. The method of claim 345, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

347. 347. The method of claim 346, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

348. The method of any one of claims 338 to 347, wherein the annulus marking device comprises a plurality of radiopaque filaments coupled to the plurality of concentric wire loops, the method further comprising the step of determining that the annulus marking device is located at at least a portion of a valve leaflet in response to viewing movement of at least some of the plurality of radiopaque filaments in response to valve movement.

349. The method of claim 348, further comprising determining that the annulus marking device is located at at least a portion of the annulus in response to viewing a lack of movement of at least a first portion of the plurality of radiopaque filaments when a second portion of the plurality of radiopaque filaments is moving in response to movement of the valve.

350. The method of any one of claims 338 to 349, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

351. The method of claim 350, wherein the step of retrieving the annulus marking device includes the step of transitioning the annulus marking device from the expanded state to the compressed state by pulling proximally a locking ring disposed within the center of the plurality of concentric wire loops.

352. placing an annulus marking device comprising a radiopaque material at a native heart valve annulus of a subject, the annulus marking device being shaped to define a plurality of radiopaque petals or loops, the annulus marking device being in a compressed state during delivery to the native heart valve and being expandable from the compressed state for positioning along the native heart valve annulus; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

353. wherein positioning the annulus marking device comprises delivering the annulus marking device using a delivery tool; the annulus marking device surrounds the delivery tool; 353. The method of claim 352, wherein implanting the implant comprises delivering the implant through a lumen of the delivery tool surrounded by the annulus marking device.

354. The method of claim 352 or 353, wherein the step of placing the annulus marking device includes the step of measuring annulus height using the annulus marking device.

355. 355. The method of any one of claims 352 to 354, wherein implanting the implant under imaging comprises implanting using fluoroscopy.

356. The method of any one of claims 352 to 355, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

357. 357. The method of any one of claims 352 to 356, wherein the step of positioning the annulus marking device comprises the step of positioning the annulus marking device along a mitral valve annulus.

358. 357. The method of any one of claims 352 to 356, wherein the step of positioning the annulus marking device comprises the step of positioning the annulus marking device along the annulus of a tricuspid valve.

359. The method of any one of claims 352 to 358, wherein at least one of the plurality of petals or loops is a larger petal or loop than other petals or loops, and the step of positioning the annulus marking device includes the step of positioning the annulus marking device within the valve such that the larger petal is positioned between the leaflets of the valve.

360. The method of any one of claims 352 to 359, wherein the step of implanting an implant using the annulus marking device as a guide includes the step of viewing the shape of each of a plurality of petals or loops.

361. The method of claim 360, wherein the step of viewing the shape includes a step of determining that the annulus marking device is located at the annulus in response to viewing a bend in at least one of the plurality of petals or loops.

362. The method of claim 360, wherein the step of viewing the shape includes the step of determining that the annulus marking device is located at at least a portion of a valve leaflet in response to viewing movement of at least one of the plurality of petals or loops in response to movement of at least one of the plurality of petals or loops.

363. 363. The method of any one of claims 352 to 362, wherein the method further comprises the step of viewing tissue of the native heart valve annulus and tissue associated therewith under imaging of the plurality of petals or loops.

364. 364. The method of claim 363, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith comprises the step of imaging the plurality of petals or loops relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of petals or loops relative to the tissue.

365. 365. The method of claim 364, wherein viewing the plurality of petals or loops comprises viewing movement of the plurality of petals or loops in response to movement of the tissue.

366. The method of claim 363, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

367. a guidewire having a distal end configured to assume a predefined shape in an expanded state of the guidewire; a valve annulus marking device comprising a plurality of radiopaque filaments coupled to a distal end of the guidewire; A system that provides.

368. 368. The system of claim 367, wherein each of the plurality of radiopaque filaments comprises a flexible material.

369. 369. The system of any one of claims 367 to 368, further comprising a tube, wherein a distal end of the guidewire at least partially surrounds a portion of the tube in the expanded state of the guidewire.

370. 370. The system of claim 369, further comprising an implant deliverable through the lumen of the tube, the plurality of radiopaque filaments configured to guide implantation of the implant.

371. positioning a distal end of a guidewire within a lumen of a subject's heart, the guidewire configured to assume a predefined shape in an expanded state of the guidewire, the distal end of the guidewire coupled to a valve annulus marking device including a plurality of radiopaque filaments; moving the distal end of the guidewire along tissue surrounding the heart lumen; imaging the tissue surrounding the heart lumen by viewing the movement of the distal end of the guidewire and the plurality of radiopaque filaments; The method includes:

372. The method of claim 371, wherein the step of moving the distal end of the guidewire along tissue includes the step of measuring the height of the native annulus of the heart valve using the annulus marking device.

373. 373. The method of claim 371 or 372, wherein the imaging step includes imaging using fluoroscopy.

374. 374. The method of any one of claims 371 to 373, wherein the step of positioning the distal end of the guidewire comprises the step of positioning the distal end of the guidewire along an annulus of a mitral valve.

375. 374. The method of any one of claims 371 to 373, wherein the step of positioning the distal end of the guidewire comprises the step of positioning the distal end of the guidewire along an annulus of a tricuspid valve.

376. The method of any one of claims 371 to 375, wherein the step of positioning the distal end of the guidewire comprises the step of positioning the distal end of the guidewire within a sub-annular space of the subject's native heart valve.

377. 377. The method of any one of claims 371 to 376, wherein imaging the tissue surrounding the lumen includes using the multiple radiopaque filaments to view tissue of the native heart valve annulus and tissue associated therewith.

378. The method of claim 377, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the plurality of radiopaque filaments against the tissue.

379. The method of claim 377, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

380. implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and 380. The method of any one of claims 371 to 379, further comprising:

381. The implant is delivered through a tube; a distal end of the guidewire encircling a portion of the tube; 381. The method of claim 380, wherein the step of implanting the implant along the subject's native heart valve annulus comprises the step of guiding a portion of the tube along the annulus using the annulus marking device.

382. Expanding an annulus marking device comprising a radiopaque material within an atrium of a subject's heart, the annulus marking device comprising: (1) a first radiopaque loop; (2) shaped to define a second radiopaque loop configured to pivot and tilt relative to the first radiopaque loop; Steps and canting the second radiopaque loop relative to the first radiopaque loop to allow the second radiopaque loop to pivot along a plane that is at a non-zero angle relative to the plane of the first radiopaque loop; (1) positioning the annulus marking device at least partially within a native heart valve of the heart such that the first radiopaque loop is disposed between the leaflets of the native heart valve, an upper portion of the first radiopaque loop is disposed within the atrium, and a lower portion of the first radiopaque loop is disposed within the ventricle of the heart; and (2) the second radiopaque loop is disposed along an atrial surface of an annulus of the valve, the annulus marking device being in a fully expanded state. compressible to a compressed state during delivery to the native heart valve; expandable from a compressed state to an expanded state for positioning within the native heart valve. Steps and implanting the implant along the valve annulus using the annulus marking device as a guide for implanting the implant along the valve annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

383. 383. The method of claim 382, ​​wherein the step of implanting under imaging includes the step of implanting using fluoroscopy.

384. The method of claim 382 or 383, wherein the step of positioning the annulus marking device includes the step of positioning the annulus marking device on a mitral valve.

385. The method of claim 382 or 383, wherein the step of positioning the annulus marking device includes the step of positioning the annulus marking device in a tricuspid valve.

386. The method of any one of claims 382 to 385, wherein the step of retrieving the annulus marking device after implantation comprises the step of pivoting and tilting the second radiopaque loop relative to the first radiopaque loop.

387. The method of any one of claims 382 to 386, wherein the step of positioning the annulus marking device comprises the steps of positioning the first radiopaque loop between the valve leaflets and, by said positioning, applying a force to the commissures of the valve by the first radiopaque loop.

388. The method of any one of claims 382 to 387, wherein the first radiopaque loop and the second radiopaque loop each include a wire frame at least partially surrounded by a respective radiopaque spring, and wherein positioning the annulus marking device includes allowing the radiopaque springs to compress and expand.

389. The method of any one of claims 382 to 388, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

390. 390. The method of any one of claims 382 to 389, wherein the method further comprises using the annulus marking device to view tissue of the native heart annulus and tissue associated therewith.

391. The method of claim 390, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

392. 391. The method of claim 390, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

393. The method of any one of claims 382 to 392, further comprising the step of moving the second radiopaque loop vertically along a portion of the first radiopaque loop in the fully expanded state of the annulus marking device.

394. 394. The method of claim 393, wherein the step of vertically moving the second radiopaque loop along a portion of the first radiopaque loop comprises the step of measuring a height of the annulus.

395. a valve annulus marking device, the valve annulus marking device comprising: A central rod, two or more expandable wires connected at respective proximal and distal ends to the central rod, each of the two or more expandable wires being shaped to define an irregular section that conforms to the native heart annulus of a subject valve; at least one ultrasonic transducer slidable along the central rod in a rotational manner relative to the central rod; wherein the annulus marking device comprises: compressible to a compressed state during delivery to the native heart valve; A device expandable from a compressed state to an expanded state for positioning within the native heart valve.

396. The apparatus of claim 395, further comprising an implant implantable into the annulus under guidance from imaging using the annulus marking device.

397. 397. The apparatus of claim 395 or 396, wherein the central rod is hollow and the at least one ultrasonic transducer is disposed within the central rod.

398. 40. The device of any one of claims 395 to 397, further comprising at least one radiopaque marker slidable along one of the expandable wires until the radiopaque marker abuts the valve annulus.

399. 400. The apparatus of claim 398, wherein the at least one radiopaque marker comprises a wiring.

400. 400. The device of claim 399, wherein the at least one radiopaque marker comprises a plurality of radiopaque filaments coupled to the wiring.

401. Expanding an annulus marking device within a subject's native heart valve, the annulus marking device is shaped to define two or more expandable wires connected at respective proximal and distal ends to a central rod, the two or more expandable wires each shaped to define a concave-convex section that conforms to a native heart annulus of a valve, the annulus marking device comprising: compressible to a compressed state during delivery to the native heart valve; expandable from a compressed state to an expanded state for positioning within the native heart valve. Steps and sliding at least one ultrasonic transducer along and relative to the central rod in a rotational manner; imaging an annulus of a valve using the ultrasound transducer; implanting the implant along the valve annulus using the annulus marking device as a guide for implanting the implant along the valve annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

402. 402. The method of claim 401, wherein imaging the annulus includes measuring the height of the annulus.

403. The method of claim 401 or 402, wherein the step of expanding the annulus marking device includes the step of expanding the annulus marking device at a mitral valve.

404. The method of claim 401 or 402, wherein the step of expanding the annulus marking device includes the step of expanding the annulus marking device in a tricuspid valve.

405. 405. The method of any one of claims 401 to 404, wherein expanding the annulus marking device comprises expanding the two or more expandable wires between the leaflets of the valve, and applying a force to the commissures of the valve by the two or more expandable wires by the expansion.

406. The method of any one of claims 401 to 405, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

407. The method of any one of claims 401 to 406, wherein the expanding step includes a step of positioning the annulus marking device within a native heart valve of the heart such that the two or more expandable wires are positioned between the leaflets of the native heart valve, with an upper portion of each expandable wire being positioned within an atrium and a lower portion of each expandable wire being positioned within a ventricle.

408. sliding a radiopaque marker vertically along one of the expandable wires until the radiopaque marker abuts the valve annulus; imaging the valve annulus under fluoroscopy; The method of claim 407, further comprising:

409. 409. The method of claim 408, wherein the step of sliding the radiopaque marker includes the step of measuring the height of the annulus.

410. 410. The method of any one of claims 401 to 409, further comprising using the annulus marking device to view tissue of the native heart annulus and tissue associated therewith.

411. The method of claim 410, wherein viewing the tissue of the native heart annulus and tissue associated therewith comprises imaging the annulus marking device relative to the tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

412. 412. The method of claim 411, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

413. Positioning a valve annulus marking device including a clip within a chamber of a subject's heart, said clip comprising: radiopaque material, a first gripper and a second gripper coupled together at a hinge point, each gripper having an end and a base; and a first filament and a second filament extending from an end or base of each of the first and second jaws; Steps and using the clip to clamp together a first leaflet and a second leaflet of the subject heart valve, whereby the first filament abuts an atrial surface of at least one of the first and second leaflets such that an end of the first filament is positioned near an atrial wall and near a hinge of a valve annulus; allowing the second filament to abut a ventricular surface of at least one of the first and second leaflets such that an end of the second filament is positioned within a semi-annular groove of the valve proximate a ventricular wall. Steps and implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; The method includes:

414. 414. The method of claim 413, further comprising the step of retrieving the annulus marking device after implantation.

415. 415. The method of claim 413 or 414, wherein the first filament and the second filament comprise a superelastic material.

416. 416. The method of any one of claims 413 to 415, wherein the fastening step comprises the step of implanting the annulus marking device.

417. 417. The method of claim 416, wherein the step of implanting the annulus marking device comprises attaching at least one of the first filament and the second filament to the valve.

418. 418. The method of any one of claims 413 to 417, wherein the step of implanting under imaging comprises the step of implanting using fluoroscopy.

419. The method of any one of claims 413 to 418, wherein the step of positioning the annulus marking device within the ventricle includes a step of positioning the annulus marking device within the left ventricle, and the step of fastening the leaflets together includes a step of fastening the leaflets of a mitral valve.

420. The method of any one of claims 413 to 418, wherein the step of positioning the annulus marking device within the ventricle includes a step of positioning the annulus marking device within the right ventricle, and the step of fastening the leaflets together includes a step of fastening the leaflets of a tricuspid valve.

421. 420. The method of any one of claims 413 to 419, wherein the fastening step includes creating a double opening in the mitral valve.

422. 422. The method of any one of claims 413 to 421, further comprising the step of using the first filament and the second filament to view tissue of the native heart valve annulus and tissue associated therewith.

423. The method of claim 422, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith comprises imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the first filament and the second filament against the tissue.

424. 424. The method of claim 423, wherein viewing the first and second filaments comprises viewing movement of the first and second filaments in response to movement of the tissue.

425. The method of claim 422, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

426. Positioning a valve annulus marking device in a chamber of a subject's heart, the clamp comprising: radiopaque material, a first arm and a second arm joined together at a hinge point, each arm having an end; and a first curved element and a second curved element coupled to respective ends of the first arm and the second arm; Steps and using the clamp to clamp a leaflet of the subject heart valve between the first arm and the second arm, the first curved element abuts an atrial surface of a leaflet adjacent a hinge of the valve annulus adjacent the atrial wall; enabling the second curved element to abut the ventricular surface of the valve leaflet within a semi-annular groove of the valve adjacent the ventricular wall. Steps and implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; The method includes:

427. 427. The method of claim 426, further comprising the step of retrieving the annulus marking device after implantation.

428. 428. The method of claim 426 or 427, wherein implanting the implant under imaging comprises implanting using fluoroscopy.

429. The method of any one of claims 426 to 428, wherein the step of positioning the annulus marking device within the ventricle includes a step of positioning the annulus marking device within the right ventricle, and the step of clamping includes a step of clamping the leaflets of a tricuspid valve.

430. The method of any one of claims 426 to 428, wherein the step of positioning the annulus marking device within the ventricle includes a step of positioning the annulus marking device within the left ventricle, and the step of clamping includes a step of clamping the leaflets of a mitral valve.

431. 431. The method of any one of claims 426 to 430, further comprising using the first curved element and the second curved element to view tissue of the native heart valve annulus and tissue associated therewith.

432. The method of claim 431, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the first curved element and the second curved element relative to the tissue.

433. 433. The method of claim 432, wherein viewing the first and second curved elements comprises viewing movement of the first and second curved elements in response to movement of the tissue.

434. The method of claim 431, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

435. Delivering a valve annulus marking device including a balloon into a native heart valve of a subject's heart, the balloon comprising: an upper inflatable section inflatable to assume a generally paddle shape; a lower inflatable section inflatable to assume a spherical shape; and a central waist between the upper and lower inflatable sections; Steps and positioning the balloon such that the upper inflatable section is disposed within an atrium of the heart, the lower inflatable section is disposed within a ventricle of the heart, and the central waist is disposed between the leaflets of a valve; inflating the balloon such that the upper inflatable section expands to assume the generally paddle shape and the lower inflatable section expands to assume the spherical shape; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; The method includes:

436. 436. The method of claim 435, wherein implanting the implant comprises implanting the implant between an outer surface of an upper expandable element and an atrial wall of the heart.

437. The method of claim 435 or 436, further comprising the step of retrieving the annulus marking device after implantation.

438. 438. The method of any one of claims 435 to 437, wherein the upper surface of the upper inflatable section is sloped.

439. 439. The method of any one of claims 435 to 438, wherein the step of implanting under imaging comprises the step of implanting using fluoroscopy.

440. 440. The method of any one of claims 435 to 439, wherein the balloon is shaped to define an hourglass shape in at least one cross section thereof.

441. The method of any one of claims 435 to 440, wherein the step of positioning the annulus marking device within the valve includes the step of positioning the annulus marking device within the mitral valve.

442. The method of any one of claims 435 to 440, wherein the step of positioning the annulus marking device within the valve includes the step of positioning the annulus marking device within a tricuspid valve.

443. 443. The method of any one of claims 435 to 442, wherein the upper inflatable section is less flexible than the lower inflatable section.

444. 444. The method of claim 443, wherein the upper inflatable section is inflexible.

445. 445. The method of any one of claims 435 to 444, further comprising using the balloon to view tissue of the native heart valve annulus and tissue associated therewith.

446. The method of claim 445, wherein the balloon comprises a radiopaque material.

447. 446. The method of claim 445, wherein inflating the balloon comprises inflating the balloon with a radiopaque fluid.

448. The method of claim 445, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing an upper expandable element and a lower expandable element against the tissue.

449. The method of claim 445, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

450. delivering a balloon-containing annulus marking device within a ventricle of a native heart valve of a subject's heart; inflating the balloon within the ventricle; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

451. 451. The method of claim 450, wherein inflating the balloon includes inflating the balloon to assume a spherical shape.

452. 451. The method of claim 450, wherein inflating the balloon includes inflating the balloon to assume an annular shape.

453. 453. The method of any one of claims 450 to 452, wherein implanting the implant under imaging comprises implanting using fluoroscopy.

454. The method of any one of claims 450 to 453, wherein the step of delivering an annulus marking device within the ventricle includes the step of positioning the annulus marking device within the left ventricle.

455. The method of any one of claims 450 to 453, wherein the step of delivering an annulus marking device within the ventricle includes the step of positioning the annulus marking device within a right ventricle.

456. 456. The method of any one of claims 450 to 455, wherein the balloon comprises a magnetic material within a space defined by the balloon, and the step of implanting the implant under imaging comprises the steps of attracting the magnetic material to an upper surface of the balloon and marking the annulus of the valve from the ventricular surface of the valve.

457. The method of claim 456, wherein the step of delivering the annulus marking device includes a step of delivering the annulus marking device using a delivery tool including a magnet, and the step of attracting the magnetic material to the upper surface of the balloon includes a step of using the magnet of the delivery tool.

458. the magnet comprises a circular magnet; delivering the annulus marking device using the delivery tool includes positioning the magnet on an atrial surface of the valve; 458. The method of claim 457, wherein implanting the implant includes implanting the implant between an outer surface of the magnet and an atrial wall.

459. The method of any one of claims 450 to 458, further comprising using the balloon to view tissue of the native heart valve annulus and tissue associated therewith.

460. 460. The method of claim 459, wherein the balloon comprises a radiopaque material.

461. 460. The method of claim 459, wherein inflating the balloon comprises inflating the balloon with a radiopaque fluid.

462. The method of claim 459, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the balloon against the tissue.

463. The method of claim 459, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

464. Delivering an annulus marking device within a native heart valve of a subject's heart, the annulus marking device comprising: an upper expandable element expandable to assume a first annular shape; and a lower expandable element expandable to assume a second annular shape; Steps and positioning the annulus marking device such that the upper expandable element is disposed within an atrium of the heart and the lower expandable element is disposed within a ventricle of the heart; expanding the upper and lower expandable elements such that the upper expandable element expands to assume the first annular shape and the lower expandable element expands to assume the second annular shape; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; The method includes:

465. 465. The method of claim 464, wherein implanting the implant comprises implanting the implant between an outer surface of the upper expandable element and an atrial wall of the heart.

466. The method of claim 464 or 465, further comprising the step of retrieving the annulus marking device after implantation of the implant.

467. 467. The method of any one of claims 464 to 466, wherein the step of implanting the implant under imaging includes implanting using fluoroscopy.

468. The method of any one of claims 464 to 467, wherein the step of positioning the annulus marking device within the valve includes the step of positioning the annulus marking device within the mitral valve.

469. The method of any one of claims 464 to 467, wherein the step of positioning the annulus marking device within the valve comprises the step of positioning the annulus marking device within a tricuspid valve.

470. 470. The method of any one of claims 464 to 469, wherein the upper and lower expandable elements comprise a flexible material.

471. 470. The method of any one of claims 464 to 469, wherein the upper and lower expandable elements comprise a non-compliant material.

472. 472. The method of any one of claims 464 to 471, wherein the upper and lower expandable elements are separate.

473. The method of any one of claims 464 to 471, wherein the annulus marking device comprises a single balloon including the upper and lower expandable elements coupled together.

474. 474. The method of claim 473, wherein the balloon comprises a central waist between the upper and lower expandable elements.

475. 475. The method of claim 474, wherein the balloon is shaped to define an hourglass shape in at least one cross section thereof.

476. 475. The method of claim 474, wherein the step of positioning the annulus marking device comprises the step of positioning the central waist between the leaflets of the valve.

477. The method of any one of claims 464 to 476, further comprising the step of using the annulus marking device to view tissue of the native heart annulus and tissue associated therewith.

478. The method of claim 477, wherein the annulus marking device comprises a radiopaque material.

479. 478. The method of claim 477, wherein inflating the annulus marking device comprises inflating the annulus marking device with a radiopaque fluid.

480. The method of claim 477, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the upper and lower expandable elements relative to the tissue.

481. The method of claim 477, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

482. delivering an annulus marking device including at least a first magnetic element to one or more surfaces of a native heart valve of a subject's heart, the one or more surfaces being selected from the group consisting of an atrial surface and a ventricular surface; generating a magnetic field around the at least a first magnetic element; implanting the implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

483. 483. The method of claim 482, wherein the at least a first magnetic element comprises a round wire.

484. 483. The method of claim 482, wherein the at least a first magnetic element comprises a flat disk.

485. 483. The method of claim 482, wherein the at least a first magnetic element comprises an annular body.

486. 486. The method of any one of claims 482 to 485, wherein generating the magnetic field includes preventing movement of the magnetic element relative to tissue of the valve.

487. 487. The method of any one of claims 482 to 486, wherein generating the magnetic field includes positioning the magnetic element in a suitable location relative to valve tissue.

488. 488. The method of any one of claims 482 to 487, wherein the step of implanting the implant under imaging comprises implanting using fluoroscopy.

489. The method of any one of claims 482 to 488, wherein the step of delivering the annulus marking device includes the step of delivering the annulus marking device to a mitral valve.

490. The method of any one of claims 482 to 488, wherein the step of delivering the annulus marking device includes the step of delivering the annulus marking device to a tricuspid valve.

491. 491. The method of any one of claims 482 to 490, wherein generating a magnetic field around the at least first magnetic element comprises providing an external magnetic field.

492. The method of claim 491, wherein the step of delivering the annulus marking device includes a step of positioning the at least a first magnetic element on the atrial surface, and the step of generating the magnetic field includes a step of generating the magnetic field from within a ventricle of the heart.

493. The method of claim 491, wherein the step of delivering the annulus marking device includes a step of positioning the at least a first magnetic element on the ventricular surface, and the step of generating the magnetic field includes a step of generating the magnetic field from within an atrium of the heart.

494. the step of delivering at least a first magnetic element includes delivering the first magnetic element to an atrial surface of a valve; the method further comprising delivering a second magnetic element to the ventricular surface of the valve; 494. The method of any one of claims 482 to 493, wherein generating the magnetic field comprises generating the magnetic field in response to delivering the second magnetic element.

495. 495. The method of claim 494, wherein implanting the implant comprises implanting the implant between an outer surface of the first magnetic element and an atrial wall.

496. The method of any one of claims 482 to 495, further comprising the step of using the at least first magnetic element to view tissue of the native heart valve annulus and tissue associated therewith.

497. The method of claim 496, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the first magnetic element against the tissue.

498. The method of claim 496, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

499. placing an annulus marking device comprising a coiled wire comprising a radiopaque material on a surface of a subject's native heart valve annulus along at least a portion of a periphery of the surface of the native heart valve annulus; imaging the coiled wire to facilitate imaging of the native heart valve annulus; implanting the implant along the subject's native heart annulus using the coiled wire as a guide for implanting the implant along the annulus under imaging with the annulus marking device positioned; retrieving the annulus marking device after implantation; and The method includes:

500. 500. The method of claim 499, wherein the step of implanting under imaging includes the step of implanting using fluoroscopy.

501. The method of claim 499 or 500, wherein the step of placing the annulus marking device comprises placing the annulus marking device on a surface of the native mitral valve.

502. The method of claim 499 or 500, wherein the step of placing the annulus marking device comprises the step of placing the annulus marking device on a surface of a native tricuspid valve.

503. The method of any one of claims 499 to 502, wherein the step of positioning the annulus marking device comprises the steps of: (1) anchoring a first end of the coiled wire to a first commissure of the valve; (2) allowing the coiled wire to expand along a portion of the circumference of the valve; and (3) anchoring a second end of the coiled wire to a second commissure of the valve.

504. 504. The method of claim 503, wherein the step of allowing the coiled wire to expand along a portion of the circumference of the valve comprises the step of applying a compressive force to a portion of the valve annulus at the portion of the circumference of the valve.

505. The method of claim 503, wherein the step of positioning the annulus marking device comprises positioning the annulus marking device along an atrial surface of the valve; (1) the step of anchoring a first end of the coiled wire to a first commissure of the valve comprises anchoring the first end to the first commissure using a first anchor that locks it in place at the first commissure within a ventricle of the subject's heart; and (2) the step of anchoring a second end of the coiled wire to a second commissure of the valve comprises anchoring the second end to the second commissure using a second anchor that locks it in place at the second commissure within a ventricle of the subject's heart.

506. The method of claim 503, wherein the valve comprises a mitral valve, (1) anchoring a first end of the coiled wire to a first commissure of the valve comprises anchoring the first end to an anterior-lateral commissure of the valve, (2) allowing the coiled wire to expand along a portion of a circumference of the valve comprises allowing the coiled wire to expand along a posterior circumference of the valve, and (3) anchoring a second end of the coiled wire to a second commissure of the valve comprises anchoring the second end of the coiled wire to a posterior-medial commissure of the valve.

507. 505. The method of claim 504, wherein implanting the implant comprises implanting the implant around an outer periphery of the annulus marking device in response to the compressive force.

508. The method of any one of claims 499 to 507, further comprising the step of viewing tissue of the native heart annulus and tissue associated therewith under imaging of the annulus marking device.

509. The method of claim 508, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the annulus marking device relative to the tissue.

510. 510. The method of claim 509, wherein viewing the annulus marking device comprises viewing movement of the annulus marking device in response to movement of the tissue.

511. The method of claim 508, wherein viewing the tissue of the native heart valve annulus and tissue associated therewith includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

512. placing an annulus marking device comprising a radiopaque material within a native heart valve of a subject's heart, said annulus marking device shaped to define an expandable element that expands within said native heart valve such that the expandable element provides an indication as to a location of a native heart valve annulus of said subject's native heart valve, said annulus marking device comprising: compressible during delivery to the native heart valve; expandable from a compressed state for positioning within at least the native heart valve; Steps and expanding the annulus marking device to an expanded state; implanting the implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting the implant along the native heart valve annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

513. 513. The method of claim 512, wherein the step of implanting under imaging includes the step of implanting using fluoroscopy.

514. The method of claim 512 or 513, wherein retrieving the annulus marking device after implantation comprises constraining the annulus marking device within a tool and extracting the annulus marking device from the subject.

515. 515. The method of any one of claims 512 to 514, wherein the step of placing the annular marking device includes placing the mitral annular marking device in the mitral valve.

516. 515. The method of any one of claims 512 to 514, wherein the step of placing the annulus marking device comprises placing the annulus marking device in a tricuspid valve.

517. 517. The method of any one of claims 512 to 516, wherein expanding the expandable device comprises expanding the expandable device to assume a generally spherical shape, and implanting the implant comprises positioning the implant between the annulus marking device and tissue of an atrial wall.

518. 518. The method of claim 517, wherein the expandable element comprises a plurality of expandable elements comprising a mesh of a plurality of woven radiopaque fabric fibers.

519. 518. The method of claim 517, wherein the expandable element comprises a plurality of expandable elements comprising a mesh of a plurality of woven radiopaque metal fibers.

520. The method of claim 517, wherein the expandable element comprises a balloon.

521. 521. The method of any one of claims 512 to 520, the method further comprising the step of viewing tissue of the native heart annulus and tissue associated therewith by viewing the annulus marking device.

522. The method of claim 521, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the expandable element relative to the tissue of the native heart valve annulus and tissue associated therewith by viewing the expandable element relative to the tissue.

523. The method of claim 521, wherein viewing the expandable element includes viewing movement of the expandable element in response to movement of the tissue.

524. The method of claim 521, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the expandable element against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

525. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; wherein the annulus marking device comprises: a scaffold comprising a radiopaque material, the scaffold being foldable and expandable and configured to laterally compress tissue of a heart valve when expanded; A system comprising a plurality of radiopaque elements coupled to the scaffold and configured to mark the native heart valve annulus and tissue coupled thereto.

526. 526. The system of claim 525, wherein the body portion of the implant comprises a plurality of radiopaque markings at respective locations along the body portion.

527. The system of claim 525 or 526, wherein each of the plurality of radiopaque elements comprises a flexible material.

528. 528. The system of any one of claims 525 to 527, wherein each of the plurality of radiopaque elements comprises a radiopaque filament.

529. The system of any one of claims 525 to 528, wherein the scaffold is configured to compress tissue of the valve leaflets such that, when the scaffold is expanded, the leaflets present two accessory leaflets.

530. The system of any one of claims 525 to 529, wherein the annulus marking device is coupled to a delivery tool, and the annulus marking device is retrievable upon removal of the delivery tool from the subject.

531. The system of any one of claims 525 to 530, wherein the scaffold comprises at least one rod having a vertical orientation when the scaffold is expanded.

532. The system of claim 531, wherein when the scaffolding is expanded, the rods are configured to extend from an atrial side of the heart valve toward a ventricular side of the heart valve.

533. The system of claim 531, wherein the plurality of radiopaque elements comprises a plurality of radiopaque filaments, and the rod is coupled to the plurality of radiopaque filaments such that when the scaffold is expanded, the plurality of radiopaque filaments are compressed against tissue of the native heart valve annulus and tissue coupled thereto, such that the plurality of radiopaque filaments are configured to provide indication of the native heart valve annulus and tissue coupled thereto.

534. The system of claim 533, wherein the at least one rod comprises a plurality of rods and the scaffold comprises an expandable basket coupled to the plurality of rods, such that the scaffold expands circumferentially relative to the native heart valve such that the plurality of rods are disposed circumferentially relative to the native heart valve.

535. The scaffolding material is A central rod; a laterally expandable upper element configured to expand laterally away from the central rod; a laterally expandable lower element configured to expand laterally away from the central rod; at least one flexible wire coupled between the laterally expandable upper element and the laterally expandable lower element and extending between the laterally expandable upper element and the laterally expandable lower element; Equipped with The system of claim 525, wherein the at least one flexible wire is configured to compress tissue of the heart valve when the scaffold is expanded.

536. 536. The system of claim 535, wherein the laterally expandable upper element and the laterally expandable lower element are longitudinally movable relative to the central rod to control tension in the at least one flexible wire.

537. The system of claim 535, wherein when the scaffold is expanded, the laterally expandable upper element is configured to be positioned within an atrium of the subject's heart and the laterally expandable lower element is configured to be positioned within a ventricle of the subject's heart.

538. The system of claim 535, wherein the laterally expandable upper element comprises a first expandable and collapsible ring, the laterally expandable lower element comprises a second expandable and collapsible ring, the at least one wire comprises at least two wires joined at corresponding locations circumferentially along the first and second rings, and the first and second rings are in an expanded state when the scaffold is expanded.

539. The system of claim 535, wherein the laterally expandable upper element comprises a first expandable and foldable cross beam extending laterally away from the central rod, the laterally expandable lower element comprises a second expandable and foldable cross beam extending laterally away from the central rod, the at least one wire comprises at least two wires joined at corresponding locations along the first and second cross beams, and the first and second cross beams are in an expanded state when the scaffold is expanded.

540. The scaffolding material is A central rod; a first loop element configured to expand laterally away from the central rod; a second loop element configured to expand laterally away from the central rod; at least one curved flexible wire coupled to and extending from the rod within a space defined by at least the first loop element and the second loop element; a first magnet coupled to an end of the flexible wire; wherein the first magnet is movable by a second magnet not coupled to the scaffold; The system of claim 525, wherein the first loop element and the second loop element are configured to compress the tissue of the heart valve when the scaffold is expanded.

541. 541. The system of claim 540, wherein the first and second loop elements are longitudinally movable relative to the central rod to control tension in the first and second loop elements.

542. 541. The system of claim 540, further comprising a delivery tool configured to deliver the implant, the system comprising the second magnet, the delivery tool coupled to the second magnet.

543. The system of claim 540, wherein when the scaffold is expanded, a first half of each of the first and second loop elements is configured to be positioned within an atrium of the subject's heart and a second half of each of the first and second loop elements is configured to be positioned within a ventricle of the subject's heart.

544. The system of claim 540, wherein the first loop element and the second loop element comprise a radiopaque material.

545. The system of claim 540, wherein the first loop element and the second loop element are coupled to a radiopaque material.

546. The scaffolding material is A central rod; at least one curved flexible wire coupled to and extending from the rod; a first magnet coupled to an end of the flexible wire; 526. The system of claim 525, wherein a first magnetic element is movable by a second magnetic element that is not coupled to the scaffold.

547. The system of claim 546, wherein when the scaffold is expanded, (1) the at least one curved flexible wire is configured to be positioned within a ventricle of the subject's heart, and (2) the first magnetic element is configured to be positioned within a subannular space of the heart.

548. The system of claim 546, wherein the at least one curved flexible wire is longitudinally movable relative to the central rod.

549. The system of claim 546, further comprising the second magnetic element, the second magnetic element configured to be positioned within a vasculature surrounding the native heart valve.

550. The system of claim 546, wherein the at least one curved flexible wire is bonded to a radiopaque material.

551. The system of claim 546, wherein the at least one curved flexible wire comprises a radiopaque material.

552. The scaffolding material is A central rod; at least one cross beam coupled to the rod and extending laterally from said rod; a first magnetic element coupled to an end of the at least one cross beam; 526. The system of claim 525, wherein the first magnetic element is movable by a second magnetic element that is not coupled to the scaffold.

553. The system of claim 552, wherein the at least one cross beam is configured to be positioned within an atrium of the subject's heart when the scaffold is expanded.

554. The system of claim 552, wherein the at least one cross beam is longitudinally movable relative to the central rod.

555. The system of claim 552, further comprising the second magnetic element, the second magnetic element configured to be positioned within a vasculature surrounding the native heart valve.

556. The system of claim 546, wherein the at least one cross beam is coupled to a radiopaque material.

557. The system of claim 546, wherein the at least one cross beam comprises a radiopaque material.

558. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; an annulus marking device separate from the implant and removable from within the subject following implantation of the implant; wherein the annulus marking device comprises: A system comprising a plurality of radiopaque markers juxtaposed to one another at a given distance from one another, each of the plurality of radiopaque markers being deformable by tissue at different intervals to indicate the proximity of tissue to the implant.

559. The system of claim 558, wherein the multiple radiopaque markers are different sizes from each other.

560. The system of claim 558 or 559, wherein the plurality of radiopaque markers comprise concentric loops.

561. The system of any one of claims 558 to 560, wherein the plurality of radiopaque markers comprise concentric petals or loops.

562. The system of any one of claims 558 to 561, wherein the plurality of radiopaque markers comprises a plurality of radiopaque strips.

563. The system of any one of claims 558 to 562, wherein the plurality of radiopaque markers comprises a wire.

564. The system of any one of claims 558 to 563, wherein each of the plurality of radiopaque markers comprises a radiopaque sail extending from each radiopaque marker.

565. The system of any one of claims 558 to 564, wherein each of the plurality of radiopaque markers comprises a radiopaque filament extending from each radiopaque marker.

566. The system of any one of claims 558 to 565, further comprising a wire extension having at least one curved distal tip disposed at a non-zero angle relative to a proximal portion of the wire extension, the curved distal tip comprising a radiopaque material.

567. The system of claim 566, wherein the curved distal tip comprises a magnetic or ferrous material.

568. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; 13. A system for marking a native heart valve annulus comprising: an annulus marking device comprising an elongated radiopaque element and a plurality of flexible radiopaque filaments coupled to the elongated radiopaque element, the elongated radiopaque element being slidable along a body portion and a longitudinal axis of the implant; and the plurality of radiopaque filaments being configured to mark the native heart valve annulus and tissue coupled thereto.

569. The system of claim 568, wherein the annulus marking device is removable from the subject after implantation of the implant.

570. 570. The system of claim 568 or 569, wherein the body portion comprises a plurality of radiopaque markings at respective locations along the body portion.

571. 571. The system of any one of claims 568 to 570, wherein each of the plurality of radiopaque filaments comprises a flexible material.

572. The system of any one of claims 568 to 571, wherein the elongated radiopaque element comprises at least one of a wire and a rod.

573. The system of any one of claims 568 to 572, wherein the plurality of radiopaque filaments are disposed at a distal end of the elongated radiopaque element, and the annulus marking device comprises a tube coupled to a proximal end of the elongated radiopaque element, the tube surrounding the body portion and sliding relative to the body portion to move the plurality of radiopaque filaments relative to the implant.

574. The system of any one of claims 568 to 573, wherein the plurality of radiopaque filaments are disposed at a distal end of the elongated radiopaque element, the body portion comprising a plurality of small holes, and the elongated radiopaque element is slidable relative to the plurality of small holes to move the plurality of radiopaque filaments relative to the implant.

575. 575. The system of claim 574, wherein the plurality of radiopaque filaments are foldable as they pass through each of the plurality of small holes.

576. Placing an annulus marking device comprising a radiopaque material at a subject's native heart valve annulus at a first delivery angle relative to a plane of the valve leaflets, the annulus marking device comprising: (1) a radiopaque wire extension; and (2) shaped to define at least one radiopaque curved distal tip disposed at a non-zero angle relative to the wire extension; Steps and after positioning the annulus marking device, incrementally moving the annulus marking device along the leaflets, the movement effecting varying the delivery angle of the annulus marking device relative to the plane of the leaflets of the valve; determining a position of the valve annulus by varying the angle and visualizing the change in the angle; implanting the implant along the native heart annulus of the subject using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

577. The method of claim 576, wherein the step of determining the position includes the step of determining that the curved distal tip is positioned along the valve leaflet in response to visualizing the beating of the annulus marking device.

578. The method of claim 576 or 577, wherein the step of determining the position includes the step of determining that the curved distal tip is positioned at the annulus in response to visualizing that the annulus marking device does not move.

579. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; wherein the annulus marking device comprises: an expandable radiopaque braided mesh expandable from a collapsed state to a frusto-conical shape; two or more pull wires coupled to the expandable braided mesh; wherein the two or more pull wires are configured to be pulled to transition the braided mesh from the frusto-conical shape to a shape in which the braided mesh exhibits (1) a sloping upper portion configured to be positioned within an atrium of the subject's heart, (2) a bulging shelf portion configured to be positioned over a heart valve, (3) a narrow portion for positioning within the heart valve, and (4) a trumpet-shaped portion configured to expand within a ventricle of the subject's heart.

580. The system of claim 579, wherein the annulus marking device is removable from the subject after implantation of the implant.

581. 581. The system of claim 579 or 580, wherein the body portion comprises a plurality of radiopaque markings at respective locations along the body portion.

582. The system of any one of claims 579 to 581, wherein the bulging portion has a larger diameter than other portions of the annulus marking device.

583. The system of any one of claims 579 to 582, wherein the sloped top is configured to allow the implant to slide along and toward the annulus.

584. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; wherein the annulus marking device comprises: The system comprises an expandable radiopaque braided mesh expandable from a collapsed state to an expanded state, wherein in the expanded state, the braided mesh exhibits (1) a sloping upper portion configured to be positioned within an atrium of the subject's heart, and (2) an asymmetric portion to be positioned within a heart valve.

585. The system of claim 584, wherein the annulus marking device is removable from the subject after implantation of the implant.

586. The system of claim 584 or 585, wherein the body portion comprises a plurality of radiopaque markings at respective locations along the body portion.

587. The system of any one of claims 584 to 586, wherein the angled top is configured to allow the implant to slide along the angled top toward the valve annulus.

588. The system of any one of claims 584 to 587, further comprising a stabilizing rod and a tissue anchor coupled to an end of the stabilizing rod, the tissue anchor configured to be reversibly coupled to tissue of the subject's heart, the annulus marking device slidably coupled to the stabilizing rod, and the stabilizing rod configured to stabilize and guide positioning of the annulus marking device.

589. The system of any one of claims 584 to 588, wherein in the expanded state, the braided mesh exhibits a trumpet-shaped portion configured to expand within a ventricle of the subject's heart.

590. 590. The system of claim 589, wherein the trumpet-shaped portion has a larger diameter than other portions of the annulus marking device.

591. The system of any one of claims 584 to 590, further comprising a plurality of expandable snare(s) coupled to a distal end of the expandable radiopaque braided mesh, the plurality of expandable radiopaque snare(s) configured to clamp one or more native leaflets of the subject native valve.

592. 592. The system of claim 591, wherein the plurality of expandable snare comprises a rigid material.

593. 592. The system of claim 591, wherein the plurality of expandable snare comprises a flexible material.

594. The system of claim 591, wherein the plurality of expandable snare comprises a radiopaque material.

595. The system of claim 591, wherein the plurality of expandable snare extend distally from a distal end of the expandable radiopaque braided mesh and then curve proximally.

596. The system of any one of claims 584 to 595, further comprising a plurality of expandable radiopaque elements coupled to a distal end of the expandable radiopaque braided mesh, the plurality of expandable radiopaque elements configured to expand radially, such that the plurality of expandable elements provide an indication as to the location of the native heart valve annulus of the subject native heart valve.

597. The system of claim 596, wherein the plurality of radiopaque expandable elements collectively form the annulus marking device into a generally spherical shape.

598. 60. The system of claim 596, wherein the plurality of expandable radiopaque elements comprises a plurality of woven radiopaque fibers in a mesh form.

599. 60. The system of claim 596, wherein the plurality of expandable radiopaque elements comprises a plurality of curved wires.

600. The system of any one of claims 584 to 599, further comprising an expandable annular element coupled to a distal end of the expandable radiopaque braided mesh, the expandable annular element configured to position the expandable radiopaque braided mesh within the subject's native valve.

601. The system of claim 600, wherein the expandable annular element comprises a radiopaque material.

602. The system of claim 600, wherein the expandable annular element comprises an artificial valve.

603. The system of claim 600, wherein the expandable radiopaque braided mesh is positionable within the native heart valve and the inflatable annular element is positionable below the native heart valve.

604. 1. A system for use with a subject, comprising: an implant configured to be positioned along a native heart valve annulus of the subject's native heart valve, the implant comprising: a body portion comprising a flexible material, the body portion having a longitudinal axis extending along a length of the body portion; a valve annulus marking device; wherein the annulus marking device comprises: an inflatable temporary valve inflatable from a collapsed state to an expanded state in an expanded state, the inflatable temporary valve comprising: (1) a non-compliant proximal balloon configured to be positioned within the native heart valve and partially within an atrium of the subject's heart; and (2) a compliant distal balloon configured to be positioned within a sub-annular space of the native heart valve; A system comprising:

605. The system of claim 604, further comprising two or more prosthetic leaflets coupled to the temporary valve.

606. delivering an annulus marking device including at least a first magnetic element to one or more surfaces of a native heart valve of a subject's heart, the one or more surfaces being selected from the group consisting of an atrial surface and a ventricular surface; delivering a second magnetic element to a vasculature surrounding the native heart valve; generating a magnetic field around the at least a first magnetic element; implanting an implant along the subject's native heart annulus using the annulus marking device as a guide for implanting the implant along the annulus under imaging; retrieving the annulus marking device after implantation; and The method includes:

607. 607. The method of claim 606, wherein the at least a first magnetic element is coupled to a curved wire, and the step of delivering the annulus marking device includes the step of delivering the first magnetic element to the ventricular surface.

608. 607. The method of claim 606, wherein the at least a first magnetic element is coupled to an end of at least one cross beam, and the step of delivering the annulus marking device includes the step of delivering the first magnetic element to the atrial surface.

609. 609. The method of any one of claims 606 to 608, wherein generating the magnetic field includes positioning the magnetic element in a suitable location relative to valve tissue.

610. The method of any one of claims 606 to 609, wherein the step of delivering the annulus marking device includes the step of delivering the annulus marking device to at least one of a mitral valve and a tricuspid valve.

611. The method of any one of claims 606 to 610, further comprising using the at least a first magnetic element to view tissue of the native heart valve annulus and tissue associated therewith.

612. The method of claim 611, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus and tissue associated therewith by viewing the first magnetic element positioned against the tissue.

613. The method of claim 611, wherein the step of viewing the tissue of the native heart valve annulus and tissue associated therewith includes the step of imaging the annulus marking device against the tissue of the native heart valve annulus, tissue of at least one valve leaflet, and tissue of an atrial wall.

614. The annulus marking device comprises: a scaffold comprising a radiopaque material, the scaffold being foldable and expandable and configured to laterally compress tissue of the heart valve when expanded; a plurality of radiopaque elements coupled to the scaffold and configured to mark the native heart valve annulus and tissue coupled thereto; 614. The method of any one of claims 606 to 613, further comprising:

615. The method of any one of claims 606 to 613, wherein the annulus marking device further comprises a plurality of radiopaque markers juxtaposed to one another at a given distance from one another, each of the plurality of radiopaque markers being deformable by tissue at different intervals to indicate proximity of tissue to the implant.

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