Fluoroscopic visualization of the cardiac valve anatomy

Abstract

Devices and systems for visualizing internal patient anatomy, such as the interior of a patient's heart. For example, an annulus marking device can include various visualization features and elements that include radiopaque materials and facilitate visualization of cardiac valve anatomy, such as the annulus, leaflets, and / or other portions of a cardiac valve. Various visualization devices can be used to identify locations or regions for anchoring an implant to the cardiac valve anatomy.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 988,322, filed on Mar. 11, 2020, and titled "FLUOROSCOPIC VISUALIZATION OF HEART VALVE ANATOMY", and U.S. Provisional Patent Application No. 62 / 877,785, filed on Jul. 23, 2019, and titled "FLUOROSCOPIC VISUALIZATION OF HEART VALVE ANATOMY", the disclosures of which are hereby incorporated by reference in their entireties for all purposes. Background Art

[0003] The implantation of medical devices, such as in catheter - based procedures involving heart valve repair and replacement, can be assisted by fluoroscopy. Ideally, the exposure of the patient to fluoroscopy is kept to a minimum. Summary of the Invention

[0004] This summary of the invention is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any feature included in the examples of this summary of the invention is not claimed unless the claim expressly defines that feature. Also, the described features can be combined in various ways. The various features and steps described elsewhere in this disclosure can be included in the examples summarized here.

[0005] In some applications, systems and methods are provided for using a radiopaque device to assist in the implantation of a heart device under the guidance of fluoroscopy. The radiopaque device serves as a guide to facilitate enhanced imaging of the cardiac space during the implantation of a cardiac implant, thereby minimizing the patient's exposure to fluoroscopy over a given period of time.

[0006] Accordingly, in some applications, a system and / or device for use with an object is provided. The system / device includes a visualization device or anatomic structure marking device (e.g., an annulus marking device, etc.) and an implant for implantation along the native heart valve annulus of the object. The visualization device or anatomic structure marking device (e.g., an annulus marking device, etc.) contains a radiopaque material. In some embodiments, the visualization device, anatomic structure marking device, or annulus marking device is configured to provide guidance for the implantation of the implant along the annulus during implantation and can be retrieved after the implantation of the implant.

[0007] Throughout this application, the term annulus marking device is used generically, but the terms anatomical structure marking device, heart valve marking device, and visualization device may be used in place of the term "annulus marking device," and in any case, the device may be used to mark or visualize other regions within a patient's heart and / or other organs.

[0008] In some applications, the annulus marking device and / or the radiopaque material is configured and shaped to define a base frame and / or one or more struts, the base frame having a shape such that it tracks the circumference of the native heart valve annulus, and the one or more struts projecting away from the plane defined by the base frame. The one or more struts may be configured to provide an indication of one or more commissures of the native heart valve.

[0009] In some applications, the annulus marking device may be compressed during delivery toward the native heart valve and may expand from the compressed state to be positioned along the native heart valve annulus.

[0010] In one application, the annulus marking device includes a superelastic material. In one application, the base frame and the one or more struts are manufactured as a single piece.

[0011] In one application, the one or more struts are sized to provide an indication of the height of the native heart valve annulus.

[0012] In one application, the base frame is circular. In one application, the base frame is substantially D-shaped.

[0013] In one application, the base frame includes wire.

[0014] In one application, the base frame includes an adjustment mechanism that expands and contracts the perimeter of the base frame.

[0015] In one application, the adjustment mechanism includes a wire that travels at least partially within the lumen of the base frame, and the wire is pullable to adjust the perimeter of the base frame.

[0016] In one application, the adjustment mechanism includes a wire that travels at least partially within the lumen of the base frame, and the wire is twistable to adjust the perimeter of the base frame.

[0017] In one application, the adjustment mechanism includes a wire that travels at least partially within the lumen of the base frame, and at least a portion of the base frame telescopically collapses in response to pulling of the wire.

[0018] In one application, an annulus marking device includes a plurality of radiopaque filaments coupled at least to a base frame, each of the plurality of filaments projecting radially away from the base frame and configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0019] In one application, each of the plurality of radiopaque filaments comprises a flexible material.

[0020] According to some applications, a method is also provided that includes placing an annulus marking device comprising a radiopaque material at the native heart valve annulus of a subject 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 the implant.

[0021] The annulus marking device and / or the radiopaque material may be the same as or similar to any annulus marking device and / or radiopaque material described herein. In some embodiments, the annulus marking device and / or the radiopaque material is shaped to define a base frame and / or one or more struts, the base frame having a shape such that it tracks the circumference of the native heart valve annulus, and the one or more struts projecting away from the plane defined by the base frame, the one or more struts providing an indication of one or more commissures of the native heart valve.

[0022] The annulus marking device may be compressible during delivery toward the native heart valve and expandable from a compressed state to be positioned along the native heart valve annulus.

[0023] In one application, placing the annulus marking device includes measuring the height of the annulus using the annulus marking device.

[0024] In one application, the method further includes adjusting the perimeter of the base frame.

[0025] In one application, implanting under imaging includes implanting using fluoroscopy.

[0026] In one application, retrieving the annulus marking device after the implant includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

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

[0028] In one application, placing includes placing the annulus marking device along the annulus of the tricuspid valve.

[0029] In one application, an annulus marking device includes a plurality of radiopaque filaments at least coupled to a base frame, each of the plurality of radiopaque filaments projecting radially away from the base frame, and the method further includes observing tissue of a native heart valve annulus and tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0030] In one application, observing tissue of a native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0031] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0032] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of an atrial wall.

[0033] The method can be performed on a live animal or based on simulation (such as on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0034] According to some applications, a system and / or device for use with an object is also provided, the system / device including an implant configured to be placed along a native heart valve annulus. The implant includes a body portion and an annulus marking device, structure, or assembly, the body portion including a flexible material, the body portion having a longitudinal axis (e.g., when the implant and / or the body portion is straightened) that travels along the length of the body portion, the annulus marking device, structure, or assembly including a plurality of radiopaque protrusions projecting away from the longitudinal axis.

[0035] The implant may further include a contraction member coupled to the body portion. The contraction member may be coupled to and / or extend along or through the plurality of radiopaque protrusions in such a way that during application of tension to the contraction member, the contraction member is configured to change the structural configuration of the plurality of radiopaque protrusions.

[0036] In one application, the contraction member is configured to compress the plurality of radiopaque protrusions in a radial direction toward the longitudinal axis of the body portion.

[0037] In one application, the constriction member is configured to constrict the body portion during application of tension to the constriction member.

[0038] In one application, the device further includes an additional constriction member extending along the body portion, the additional constriction member being configured to constrict the body portion.

[0039] In one application, the body portion includes a plurality of radio-opaque markers configured to indicate placement of an anchor along the body portion.

[0040] In one application, the constriction member extends along the perimeter of each of the plurality of radio-opaque protrusions.

[0041] In one application, the plurality of radio-opaque protrusions are flexible and include fabric.

[0042] In one application, the body portion and the plurality of radio-opaque protrusions are flexible and include fabric.

[0043] In one application, each of the plurality of radio-opaque protrusions is shaped to define a respective flat and planar element.

[0044] In one application, each flat and planar element has a longest dimension measured along an axis that is at a non-zero angle relative to the longitudinal axis of the body portion.

[0045] In one application, each of the plurality of radio-opaque protrusions is shaped to define a plurality of tubular elements.

[0046] In one application, the constriction member extends along the perimeter of each opening of each of the plurality of tubular elements.

[0047] In one application, each of the plurality of tubular elements tapers away from the longitudinal axis of the body portion.

[0048] According to some applications, a method is also provided that includes placing an implant at a native heart valve annulus of an object, the implant being configured for placement along the native heart valve annulus and including a body portion and an annulus marking device; deploying a plurality of tissue anchors through the body portion of the implant and into the tissue of the native heart valve annulus under imaging and using the annulus marking device as a guide; and altering a structural configuration of the implant.

[0049] The implant may be the same as or similar to other implants described herein. For example, in some embodiments, the implant includes a body portion and an annulus marking device, the body portion includes a flexible material, the body portion has a longitudinal axis that travels along the length of the body portion (e.g., when the implant and / or the body portion is straightened), and the annulus marking device includes a plurality of radiopaque protrusions that project away from the longitudinal axis. The implant may include a constriction member coupled to the body portion. The constriction member may be coupled to the plurality of radiopaque protrusions and / or extend along or through the plurality of radiopaque protrusions in such a way that during application of tension to the constriction member, the constriction member is configured to change the structural configuration of the plurality of radiopaque protrusions.

[0050] In some applications, changing the structural configuration of the implant includes changing the structural configuration of the plurality of radiopaque protrusions by applying tension to the constriction member.

[0051] In one application, changing the structural configuration of the plurality of radiopaque protrusions includes compressing the plurality of radiopaque protrusions in the radial direction toward the longitudinal axis of the body portion.

[0052] In one application, applying tension to the constriction member includes adjusting the perimeter of the implant by using the constriction member to constrict the body portion.

[0053] In one application, the implant includes an additional constriction member that extends along the body portion, and the method further includes adjusting the perimeter of the implant by using the additional constriction member to constrict the body portion.

[0054] In one application, placement includes placing the implant along the annulus of the mitral valve.

[0055] In one application, placement includes placing the implant along the annulus of the tricuspid valve.

[0056] In one application, changing the structural configuration of the plurality of radiopaque protrusions includes sequentially changing the structural configuration of the plurality of radiopaque protrusions.

[0057] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of anchors along the body portion, and deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors according to the corresponding radiopaque marker.

[0058] In one application, a constricting member extends along a perimeter of each of the plurality of radiopaque projections, and altering a structural configuration of the plurality of radiopaque projections includes compressing the plurality of radiopaque projections by pulling each of the plurality of radiopaque projections toward the longitudinal axis by constricting the constricting member along the perimeter of each of the plurality of radiopaque projections.

[0059] In one application, the plurality of radiopaque projections are flexible and include fabric.

[0060] In one application, each of the plurality of radiopaque projections is shaped to define a plurality of flat and planar elements, and altering a structural configuration of the plurality of radiopaque projections includes pulling each of the plurality of radiopaque projections toward the longitudinal axis by folding each of the plurality of flat and planar elements.

[0061] In one application, each of the plurality of radiopaque projections is shaped to define a plurality of tubular elements.

[0062] In one application, the constricting member extends along a perimeter of each opening of each of the plurality of tubular elements, and altering a structural configuration of the plurality of radiopaque projections includes closing each opening of each of the plurality of tubular elements.

[0063] In one application, each of the plurality of tubular elements tapers away from a longitudinal axis of the body portion.

[0064] In one application, the method further includes observing tissue of a native heart valve annulus and tissue coupled to the native heart valve annulus under imaging of the plurality of radiopaque projections.

[0065] In one application, observing the tissue includes imaging using fluoroscopy.

[0066] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the plurality of radiopaque projections relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of radiopaque projections against the tissue.

[0067] In one application, observing the tissue of the native heart valve annulus includes imaging the plurality of radiopaque projections relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque projections in response to movement of the tissue.

[0068] In one application, imaging a annulus marking device is performed on tissue of a native heart valve annulus and tissue coupled to the native heart valve annulus, including tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0069] The method can be performed on a living animal or based on a simulation (such as on a cadaver, a cadaver heart, a simulator (such as one having a body part, tissue, etc. being simulated), etc.).

[0070] According to some applications, a system and / or device is also provided, including a tissue anchor, the tissue anchor including a distal tissue coupling element having a longitudinal axis measured from the distal end to the proximal end of the distal tissue coupling element, the distal tissue coupling element being configured to be anchored to and / or fixed to tissue of a native heart valve annulus; and an annulus marking device coupled to the tissue anchor. In some embodiments, the annulus marking device includes a radiopaque material and / or is configured to project away from the longitudinal axis of the distal tissue coupling element.

[0071] 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.

[0072] In one application, the tissue anchor includes a proximal head coupled to the proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

[0073] In one application, the device further includes an annuloplasty structure, the annuloplasty structure including a tubular body portion, and the proximal head is configured to be disposed within the tubular body portion while the distal tissue coupling element is configured to be anchored within the tissue of the native heart valve annulus.

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

[0075] In one application, the annulus marking device is coupled to the distal end of the distal tissue coupling element.

[0076] In one application, the device further includes an annuloplasty structure, the annuloplasty structure including a fabric, and the annulus marking device is configured to pass through the fabric of the annuloplasty structure.

[0077] In one application, the annulus marking device includes one or more radiopaque filaments configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0078] In one application, each of one or more radiopaque filaments comprises a flexible material.

[0079] According to some applications, a method is also provided that includes marking the position of a native heart valve annulus by implanting a tissue anchor in the tissue of the native heart valve annulus, the tissue anchor including a distal tissue-coupling element having a longitudinal axis measured from the distal end to the proximal end of the distal tissue-coupling element, the distal tissue-coupling element being configured to anchor to the tissue of the native heart valve annulus.

[0080] An annulus marking device may be coupled to the tissue anchor, the annulus marking device including a radiopaque material. The annulus marking device may be configured to project away from the longitudinal axis of the distal tissue-coupling element.

[0081] The method further includes imaging the position and, during the imaging, observing the annulus marking device relative to the tissue of the native heart valve annulus.

[0082] In one application, imaging the tissue includes imaging using fluoroscopy.

[0083] In one application, marking the position includes marking the position along the annulus of the mitral valve.

[0084] In one application, marking the position includes marking the position along the annulus of the tricuspid valve.

[0085] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus under imaging of the annulus marking device.

[0086] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0087] In one application, observing 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 the tissue coupled to the native heart valve annulus by observing the movement of the annulus marking device in response to the movement of the tissue.

[0088] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0089] In one application, the tissue anchor includes a proximal head coupled to the proximal end of the distal tissue coupling element, and the annulus marking device is coupled to the proximal head.

[0090] In one application, the method further includes implanting an annuloplasty structure along a native heart valve annulus, the annuloplasty structure including a tubular body portion, and implanting the tissue anchor includes positioning the proximal head within the tubular body portion and implanting the distal tissue coupling element within the tissue of the native heart valve annulus.

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

[0092] In one application, the annulus marking device is coupled to the distal end of the distal tissue coupling element.

[0093] In one application, the method further includes implanting an annuloplasty structure along a native heart valve annulus, the annuloplasty structure including a fabric, and implanting the tissue anchor includes passing the annulus marking device through the fabric of the annuloplasty structure.

[0094] 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 valve annulus, and the method further includes imaging the native heart valve annulus before the portion of the annuloplasty structure is positioned along the native heart valve annulus.

[0095] In one application, the annulus marking device includes one or more radiopaque filaments configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0096] In one application, each of the one or more radiopaque filaments includes a flexible material.

[0097] The method can be performed on a live animal or based on a simulation (such as on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0098] According to some applications, there is also provided a system and / or device for use with an object, the system / device including an implant configured to be placed along a native heart valve annulus. The implant may include a body portion including a flexible material, the body portion having a longitudinal axis (e.g., when the implant and / or the body portion is straightened) that travels along the length of the body portion. The implant may also include annulus marking means including one or more planar radiopaque fins that extend along at least a portion of the body portion and project away from the longitudinal axis, each of the one or more planar radiopaque fins having a longest dimension measured along the longitudinal axis.

[0099] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of an anchor along the body portion.

[0100] In one application, the one or more planar radiopaque fins include a flexible fabric.

[0101] In one application, the one or more planar radiopaque fins include two or more planar radiopaque fins.

[0102] In one application, the device further includes at least one tissue anchor that can be deployed through the body portion of the implant and into the tissue of the native heart valve annulus between the two or more planar radiopaque fins.

[0103] According to some applications, there is also provided a method including placing an implant at a native heart valve annulus of an object, the implant being configured to be placed along the native heart valve annulus, the implant including a body portion including a flexible material; and annulus marking means. The method further includes deploying at least one tissue anchor through the body portion of the implant and into the tissue of the native heart valve annulus under imaging and using the annulus marking means as a guide.

[0104] In some embodiments, the body portion has a longitudinal axis (e.g., when the implant and / or the body portion is straightened) that travels along the length of the body portion, and the annulus marking means includes one or more planar radiopaque fins that extend along at least a portion of the body portion and project away from the longitudinal axis. In some embodiments, each of the one or more planar radiopaque fins has a longest dimension measured along the longitudinal axis.

[0105] In one application, deploying under imaging includes imaging using fluoroscopy.

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

[0107] In one application, placing includes placing the implant along an annulus of the tricuspid valve.

[0108] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of anchors along the body portion, and deploying the plurality of tissue anchors includes deploying each of the plurality of tissue anchors according to a corresponding radiopaque marker.

[0109] In one application, the one or more planar radiopaque fins are flexible and comprise a fabric.

[0110] In one application, the one or more planar radiopaque fins include two or more planar radiopaque fins.

[0111] In one application, deploying the at least one tissue anchor through the body portion of the implant includes deploying the at least one tissue anchor through the body portion of the implant between the two or more planar radiopaque fins.

[0112] In one application, the method further comprises observing tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus while imaging the one or more planar radiopaque fins.

[0113] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the one or more planar radiopaque fins against the tissue.

[0114] In one application, observing the tissue of the native heart valve annulus includes imaging the one or more planar radiopaque fins relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the one or more planar radiopaque fins in response to movement of the tissue.

[0115] The method may be performed on a live animal or on a simulation basis (eg, on a cadaver, a cadaver heart, a simulator (eg, with a body part, tissue, etc. being simulated), etc.).

[0116] According to some applications, a system and / or device for use with an object is also provided. The system / device includes an implant configured to be placed along the native heart valve annulus of the object. The implant includes a body portion including a flexible material. The system / device also includes an annulus marking device.

[0117] The annulus marking device can be the same as or similar to other annulus marking devices herein. For example, in some embodiments, the annulus marking device includes a gantry including a radiopaque material. The gantry can be collapsible and expandable and is configured to travel in parallel with at least one side of the body portion of the implant when expanded. In some embodiments, a plurality of radiopaque filaments are coupled to the gantry at least at the distal end of the gantry, and the plurality of filaments are configured to mark the native heart valve annulus and / or tissue coupled to the native heart valve annulus.

[0118] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of anchors along the body portion.

[0119] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0120] In one application, the gantry includes a plurality of struts arranged together in a triangular shape, and the gantry is generally planar and travels in parallel with the sidewall of the body portion when the gantry is expanded.

[0121] In one application, the annulus marking device is coupled to a delivery tool configured to deliver the implant to the native heart valve annulus, and the annulus marking device can be retrieved after removing the delivery tool from the object.

[0122] 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.

[0123] In one application, the delivery tool includes fins coupled to a distal portion of the delivery tool and a portion of the gantry in such a way that movement of the fins in response to blood flow rotationally orients the gantry relative to the body portion of the implant.

[0124] In one application, the gantry is coupled at the proximal end of the gantry to a ring that surrounds at least a portion of the body portion of the implant and is movable proximally and distally relative to the body portion of the implant in such a way that the gantry can move to a plurality of positions along the body portion of the implant.

[0125] In one application, the stent is shaped to partially surround a given portion of the body portion of the implant, the plurality of radiopaque filaments include 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 subset and the second subset are configured to rotationally orient the stent relative to the implant.

[0126] In one application, the stent is semi-tubular. In one application, the stent is planar and generally triangular. In one application, the stent is frustoconical. However, other shapes are possible.

[0127] In one application, the stent is shaped to partially surround a given portion of the body portion of the implant, the plurality of radiopaque filaments include 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 subset and the second subset are configured to rotationally orient the stent relative to the implant.

[0128] In one application, the stent is semi-tubular. In one application, the stent is planar and generally triangular. In one application, the stent is frustoconical. However, other shapes are possible.

[0129] In one application, the stent includes a plurality of struts arranged in a frustoconical shape and the stent surrounds at least a portion of the body portion of the implant.

[0130] In one application, the stent is movable proximally and distally relative to the body portion of the implant in such a manner that the stent can be moved along the body portion of the implant to a plurality of positions.

[0131] According to some applications, there is also provided a method that includes placing an implant including a body portion at a native heart valve annulus of an object, the body portion including a flexible material; and observing the placement under imaging by imaging a valve annulus marking device.

[0132] In some applications, the valve annulus marking device includes a stent that includes a radiopaque material, the stent is collapsible and expandable, and is configured to travel in parallel with at least one side of the body portion of the implant when expanded. In some embodiments, a plurality of radiopaque filaments are coupled to the stent at least at the distal end of the stent, the plurality of filaments being configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0133] In one application, observing the placement also includes imaging a plurality of radiopaque markers on the body portion of the implant, and deploying an anchor along the body portion based on imaging the plurality of radiopaque markers on the body portion of the implant.

[0134] In one application, each of the plurality of radiopaque filaments comprises a flexible material.

[0135] In one application, the gantry comprises a plurality of struts arranged together in a triangular shape, the gantry is generally planar, and when the gantry is expanded, it travels parallel to the sidewall of the body portion, and imaging the annulus marker device includes imaging the triangular shape of the gantry relative to the tissue and the body portion of the implant.

[0136] In one application, placing the implant includes using a delivery tool coupled to the annulus marker device to deliver the implant, and the method further includes retrieving the annulus marker device during removal of the delivery tool from the subject.

[0137] In one application, the delivery tool is configured to surround a portion of the body portion of the implant, and the annulus marker device is configured to at least partially surround the body portion of the implant.

[0138] In one application, the delivery tool includes fins coupled to the distal portion of the delivery tool and a portion of the gantry, and the method further includes rotationally orienting the gantry relative to the body portion of the implant in response to movement of the fins in response to blood flow.

[0139] In one application, the gantry is coupled at the proximal end of the gantry to a ring that surrounds at least a portion of the body portion of the implant and is movable proximally and distally relative to the body portion of the implant, and the method further includes facilitating movement of the gantry along the body portion of the implant to a plurality of positions.

[0140] In one application, the gantry is shaped to partially surround a given portion of the 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, and the method further includes rotationally orienting the gantry relative to the implant using the first subset and the second subset.

[0141] In one application, the gantry is semi-tubular. In one application, the gantry is planar and generally triangular. In one application, the gantry is frustoconical. Other shapes are possible.

[0142] In one application, the scaffolding is shaped to partially surround a given portion of the body portion of the implant, the plurality of radiopaque filaments include 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 rotationally orienting the scaffolding relative to the implant using the first subset and the second subset.

[0143] In one application, the scaffolding is semi-tubular. In one application, the scaffolding is planar and generally triangular. In one application, the scaffolding is frustoconical. Other shapes are possible.

[0144] In one application, the scaffolding includes a plurality of struts arranged in a frustoconical shape and the scaffolding surrounds at least a portion of the body portion of the implant.

[0145] In one application, the scaffolding is movable proximally and distally relative to the body portion of the implant, and the method further includes facilitating movement of the scaffolding along the body portion of the implant to a plurality of positions.

[0146] The method can be performed on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as having a body part, tissue, etc. being simulated), etc.).

[0147] According to some applications, there is also provided a system and / or device for use with an object, the system / device including an annulus marking device and an implant, the annulus marking device including a radiopaque material, the implant for implantation along the annulus of the valve of the object.

[0148] The annulus marking device and / or the 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 embodiments, the annulus marking device and / or the radiopaque material is shaped to define a tubular stent body having a central longitudinal axis and configured for placement within the native heart valve of the object; and / or a plurality of extensions coupled to the proximal end of the tubular stent body and projecting away from the longitudinal axis of the stent body, the plurality of extensions configured for placement along the circumference of the annulus of the native heart valve.

[0149] The annulus marking device can be compressible during delivery toward the native heart valve and expandable from a compressed state for positioning within the native heart valve.

[0150] In one application, the annulus marking device is configured to provide guidance for implantation of the implant along the annulus during implantation and can be retrieved after implantation of the implant.

[0151] In one application, the annulus marking device comprises a superelastic material.

[0152] In one application, the stent body and the plurality of extensions are manufactured as a single piece.

[0153] In one application, the tubular stent body comprises two or more prosthetic leaflets.

[0154] In one application, the device further comprises a plurality of anchors, each of the plurality of anchors being configured to anchor the implant to the annulus of the native valve, and each of the anchors being configured to be implanted between adjacent ones of the plurality of extensions.

[0155] According to some applications, there is also provided a method that includes placing an annulus marking device at a native heart valve of a subject, the annulus marking device comprising a radiopaque material shaped to define: (1) a tubular stent body having a central longitudinal axis and configured to be placed within the native heart valve of the subject; 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 being configured to be placed along a circumference of the annulus of the native heart valve. The method further includes implanting the implant along the annulus using the annulus marking device as a guide for implanting the implant under imaging. The method may include retrieving the annulus marking device after the implanting.

[0156] In some applications, the annulus marking device may be compressed during delivery toward the native heart valve and may expand from the compressed state to be positioned within the native heart valve.

[0157] In one application, implanting under imaging includes implanting using fluoroscopy.

[0158] In one application, retrieving the annulus marking device after the implanting includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

[0159] In one application, placing includes placing the annulus marking device within the mitral valve. In one application, placing includes placing the annulus marking device within the tricuspid valve.

[0160] In one application, implanting the implant includes anchoring the implant to the annulus of the native valve by deploying a respective one of the plurality of anchors between adjacent ones of the plurality of extensions.

[0161] In one application, retrieving the annulus marking device after the implantation includes sliding the plurality of extensions under the implant.

[0162] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the plurality of extensions.

[0163] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of extensions against the tissue.

[0164] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the movement of the plurality of extensions in response to movement of the tissue.

[0165] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0166] According to some applications, a method is also provided that includes placing an annulus marking device including a mapping catheter at the native heart valve annulus of an object, generating a map of the native heart valve annulus using the mapping catheter under imaging, and implanting an implant at the native heart valve annulus under imaging in response to generating the map.

[0167] In one application, implanting under imaging includes using fluoroscopy for the implantation.

[0168] In one application, the method further includes retrieving the annulus marking device after generating the map, and subsequently removing the annulus marking device from the object.

[0169] In one application, placing includes placing the annulus marking device along the annulus of the mitral valve. In one application, placing includes placing the annulus marking device along the annulus of the tricuspid valve.

[0170] In one application, the mapping catheter includes a radiopaque material, and generating the map includes imaging the mapping catheter under fluoroscopy.

[0171] 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.

[0172] In one application, the mapping catheter includes electrodes, and generating the mapping image includes generating the mapping image using the electrodes.

[0173] 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 the implantation, and the implantation includes implanting under the guidance of the mapping image generated by the mapping catheter. In one application, retrieving the mapping catheter includes retrieving the mapping catheter after the implantation.

[0174] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the mapping catheter.

[0175] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the mapping catheter against the tissue.

[0176] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the movement of the mapping catheter in response to the movement of the tissue.

[0177] The method can be performed based on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0178] In some applications, a method is also provided, the method including placing an annulus marking device including a radiopaque material in at least the atrium of the heart of an object, the radiopaque material being shaped to define a plurality of expandable elements, the plurality of expandable elements radially expanding within the atrium such that the plurality of expandable elements provide an indication of the position of the native heart valve annulus of the native heart valve of the object. In some applications, the annulus marking device can be compressed during delivery toward the native heart valve and can expand from the compressed state to be positioned at least within the atrium. The method further includes implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging along the annulus. In some applications, the method includes retrieving the annulus marking device after the implantation.

[0179] In one application, implanting under imaging includes implanting using fluoroscopy. In one application, retrieving the annulus marker device after the implanting includes constraining the annulus marker device within a tool and removing the annulus marker device from the subject.

[0180] In one application, placement includes placing the annulus marker device in the left atrium. In one application, placement includes placing the annulus marker device in the right atrium.

[0181] In one application, a plurality of expandable elements together form the annulus marker device into a generally spherical shape, and implanting the implant includes positioning the implant between the annulus marker device and the tissue of the atrial wall.

[0182] In one application, the plurality of expandable elements includes a plurality of braided radiopaque fibers presenting a mesh.

[0183] In one application, the plurality of expandable elements includes a plurality of curved lines. In one application, implanting the implant includes positioning the implant between the annulus marker device and the tissue of the atrial wall, and deploying tissue anchors at locations along the annulus markings between consecutive curved lines.

[0184] In one application, each of the plurality of curved lines has a proximal end and a distal end and an intermediate section between the proximal end and the distal end.

[0185] In one application, the combined proximal diameter of the proximal ends of the plurality of expandable elements is equal to the combined distal diameter of the distal ends of the plurality of expandable elements, and the combined intermediate diameter of the plurality of expandable elements is greater than the combined proximal diameter and greater than the combined distal diameter.

[0186] In one application, the plurality of expandable elements together form the annulus marker device into a partial spherical shape, and implanting the implant includes positioning the implant between the annulus marker device and the tissue of the atrial wall, and deploying tissue anchors at locations along the annulus markings between consecutive expandable elements.

[0187] In one application, the plurality of expandable elements includes a plurality of struts that together form a partial spherical scaffold. In one application, the partial spherical scaffold includes a plurality of radiopaque filaments coupled to the distal end of the partial spherical scaffold, and the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0188] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of radio-opaque filaments against the tissue.

[0189] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radio-opaque filaments in response to movement of the tissue.

[0190] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0191] In one application, the plurality of expandable elements includes a plurality of curved lines.

[0192] In one application, placing the annulus marking device includes expanding the annulus marking device such that the distal end of each of the plurality of expandable elements is disposed within the atrium.

[0193] In one application, placing the annulus marking device includes expanding the annulus marking device such that the distal end of each of the plurality of expandable elements is disposed within the ventricle of the heart.

[0194] In one application, the plurality of expandable elements collectively form the annulus marking device into a partially bulbous shape, and implanting the implant includes positioning the implant between the annulus marking device and the tissue of the atrial wall, and deploying tissue anchors at locations along the annulus marked between successive expandable elements.

[0195] In one application, the method further includes delivering a radio-opaque helical stent between the plurality of expandable elements. In one application, delivering the helical stent includes delivering the helical stent between native leaflets of the native heart valve. In one application, delivering the helical stent between native leaflets of the native heart valve includes positioning the distal end of the helical stent within the ventricle of the heart of the subject.

[0196] In one application, the plurality of expandable elements includes a plurality of curved lines each having a proximal end, a distal end, and an intermediate section between the proximal and distal ends.

[0197] In one application, the combined proximal diameter of the proximal ends of the plurality of expandable elements is less than the combined distal diameter of the distal ends of the plurality of expandable elements, and the combined intermediate diameter of the plurality of expandable elements is greater than the combined proximal diameter and greater than the combined distal diameter.

[0198] In one application, placing the annulus marking device includes expanding the annulus marking device in such a manner that the distal end of each of the plurality of expandable elements is disposed within the atrium.

[0199] In one application, placing the annulus marking device includes expanding the annulus marking device in such a manner that the distal end of each of the plurality of expandable elements is disposed within the ventricle of the heart.

[0200] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of expandable elements.

[0201] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of expandable elements against the tissue.

[0202] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the movement of the plurality of expandable elements in response to the movement of the tissue.

[0203] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0204] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled at least to the distal end of the annulus marking device, and the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0205] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0206] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0207] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of an atrial wall.

[0208] The method can be performed based on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0209] According to some applications, there is also provided a system and / or device for use with an object, the system / device including:

[0210] An annulus marking device, the annulus marking device including a radiopaque material shaped to define:

[0211] (1) A tubular stent body having a central longitudinal axis and configured to be placed within the native heart valve of the object; and

[0212] (2) A frame coupled to a proximal end of the tubular stent body and protruding away from the longitudinal axis of the stent body, the frame being configured to be placed along at least a portion of the circumference of the annulus of the native heart valve, the annulus marking device:

[0213] Can be compressed during delivery toward the native heart valve, and

[0214] Can expand from a compressed state to be positioned within the native heart valve; and

[0215] An implant for implantation along the annulus of the valve of the object,

[0216] And the annulus marking device:

[0217] configured to provide a guide for implanting the implant along the annulus and within the space defined by the frame, and

[0218] retrievable after implantation of the implant.

[0219] In one application, the annulus marking device comprises a superelastic material.

[0220] In one application, the stent body and the frame are manufactured as a single piece.

[0221] In one application, the tubular stent body comprises two or more prosthetic leaflets.

[0222] According to some applications, there is also provided a method comprising placing an annulus marking device at a native heart valve of a subject, the annulus marking device comprising a radiopaque material shaped to define: (1) a tubular stent body having a central longitudinal axis and configured for placement within 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 for placement 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 toward the native heart valve and expandable from a compressed state for positioning within the native heart valve. The method further comprises implanting the implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus and within the space defined by the frame under imaging. Some methods include retrieving the annulus marking device after the implantation.

[0223] In one application, implanting under imaging includes implanting using fluoroscopy.

[0224] In one application, retrieving the annulus marking device after the implantation includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

[0225] In one application, placing includes placing the annulus marking device within the mitral valve. In one application, placing includes placing the annulus marking device within the tricuspid valve.

[0226] In one application, retrieving the annulus marking device after the implantation includes sliding the frame proximally away from the annulus around the implant.

[0227] In one application, the method further comprises observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the frame.

[0228] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the frame against the tissue.

[0229] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the frame in response to movement of the tissue.

[0230] The method can be performed on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0231] According to some applications, there is also provided a method including: placing an annulus marking device including a radiopaque material in at least an atrium of a heart of an object, the radiopaque material being shaped to define a plurality of expandable elements, the plurality of expandable elements including respective curved sections at their distal ends, the plurality of expandable elements being configured to expand radially within the atrium such that the plurality of expandable elements provide an indication of the position of the native heart valve annulus of the native heart valve of the object. In some applications, the annulus marking device can be compressed during delivery toward the native heart valve and can expand from the compressed state to be positioned at least within the atrium.

[0232] The method can also include using the annulus marking device as a guide for implanting an implant along the native heart valve annulus of the object and implanting the implant within a concave section of each of the plurality of expandable elements along the native heart valve annulus of the object. The method can also include retrieving the annulus marking device after the implanting.

[0233] In one application, placing the annulus marking device includes placing the annulus marking device when the implant is disposed within the concave section of the plurality of expandable elements.

[0234] In one application, implanting the implant includes placing the implant within the concave section of the plurality of expandable elements after placing the annulus marking device.

[0235] In one application, implanting under imaging includes implanting using fluoroscopy.

[0236] In one application, retrieving the annulus marker device after the implantation includes constraining the annulus marker device within a tool and removing the annulus marker device from the subject.

[0237] In one application, retrieving the annulus marker device after the implantation includes sliding the curved segments of the plurality of expandable elements beneath the implant.

[0238] In one application, placement includes positioning the annulus marker device in the left atrium. In one application, placement includes positioning the annulus marker device in the right atrium.

[0239] In one application, positioning the annulus marker device includes expanding the annulus marker device such that the distal end of each of the plurality of expandable elements is disposed within the atrium.

[0240] In one application, the plurality of expandable elements cooperate to form the annulus marker device in a partially pear-shaped configuration, and implanting the implant includes deploying tissue anchors at locations along the annulus markings between adjacent expandable elements.

[0241] In one application, the plurality of expandable elements cooperate to form the annulus marker device in a partially bulbous configuration, and implanting the implant includes deploying tissue anchors at locations along the annulus markings between adjacent expandable elements.

[0242] In one application, the plurality of expandable elements includes a plurality of curved lines each having a proximal end, a distal end, and an intermediate segment therebetween.

[0243] In one application, a combined proximal diameter of the proximal ends of the plurality of expandable elements is less than a combined distal diameter of the distal ends of the plurality of expandable elements, and a combined intermediate diameter of the plurality of expandable elements is greater than the combined proximal diameter and greater than the combined distal diameter.

[0244] In one application, the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of expandable elements.

[0245] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of expandable elements against the tissue.

[0246] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of expandable elements in response to movement of the tissue.

[0247] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the plurality of expandable elements relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of an atrial wall.

[0248] In one application, an annulus marking device includes a plurality of radiopaque filaments coupled at least to a distal end of the annulus marking device, and the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0249] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0250] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0251] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of an atrial wall.

[0252] The method can be performed on a live animal or based on a simulation (such as on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0253] According to some applications, there is also provided a method, which includes placing a distal portion of an annulus marking device including a radiopaque material at a ventricular surface of a native heart valve annulus of an object, the distal portion being shaped to define a curved section that curves upwardly toward the ventricular surface; facilitating imaging of the cardiac annulus by imaging movement of the distal portion of the annulus marking device along a perimeter of the ventricular surface of the native heart valve annulus; and implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging. The method may also include retrieving the annulus marking device after the implanting.

[0254] In one application, placing the distal portion of the annulus marking device at the ventricular surface includes placing the distal portion of the annulus marking device at a ventricular surface of a native mitral valve.

[0255] In one application, placing the distal portion of the annulus marking device at the ventricular surface includes placing the distal portion of the annulus marking device at a ventricular surface of a native tricuspid valve.

[0256] In one application, implanting includes implanting in conjunction with imaging movement of the distal portion of the annulus marking device.

[0257] In one application, the method further includes generating a map of the native heart valve annulus by imaging movement of the distal portion of the annulus marking device along the perimeter of the ventricular surface of the native heart valve annulus. In one application, generating the map includes generating the map before the implanting.

[0258] The method can be performed based on a live animal or based on a simulation (such as based on a cadaver, a cadaver heart, a simulator (such as having a body part, tissue, etc. being simulated), etc.).

[0259] According to some applications, there is also provided a method, which includes placing an annulus marking device including an annular stent at a surface of a native heart valve annulus of an object, the annular stent including a radiopaque material, facilitating imaging of the cardiac valve annulus by imaging movement of the distal portion of the annulus marking device along a perimeter of the ventricular surface of the native heart valve annulus, and implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging. The method may also include retrieving the annulus marking device after the implanting.

[0260] In one application, implanting the implant includes implanting the implant between the outer surface of the annular stent and the tissue of the atrial wall.

[0261] In one application, placing at the surface includes placing the annulus marking device at the atrial surface of the native heart valve annulus.

[0262] In one application, placing includes placing the annulus marking device at the surface of the native mitral valve. In one application, placing includes placing the annulus marking device at the surface of the native tricuspid valve.

[0263] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus while imaging the annulus marking device.

[0264] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0265] In one application, observing 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 the tissue coupled to the native heart valve annulus by observing the movement of the annulus marking device in response to the movement of the tissue.

[0266] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0267] In one application, the annular stent includes a plurality of radio-opaque filaments coupled to the inner surface of the annular stent, and placing the annulus marking device includes placing the annular stent along the annulus such that the plurality of radio-opaque filaments project toward the orifice of the valve, and the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the plurality of radio-opaque filaments.

[0268] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of radio-opaque filaments against the tissue.

[0269] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0270] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0271] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0272] According to some applications, a method is also provided that includes placing an annulus marking device including an implant guide device at the surface of a native heart valve annulus of an object, the implant guide device including a radiopaque material, facilitating imaging of the heart valve annulus by imaging movement of the implant guide device along a perimeter of the surface of the native heart valve annulus, and in combination with the placing, implanting an implant along the native heart valve annulus of the object using the implant guide device as a guide for implanting the implant under imaging. The method can also include retrieving the annulus marking device after the implanting.

[0273] In one application, placing the annulus marking device includes advancing the annulus marking device along an implantation path upstream of the implant.

[0274] In one application, placing includes placing the annulus marking device at the surface of the native mitral valve. In one application, placing includes placing the annulus marking device at the surface of the native tricuspid valve.

[0275] In one application, placing includes placing the annulus marking device such that a portion of the annulus marking device straddles a portion of an orifice of the valve.

[0276] In one application, the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus under imaging of the annulus marking device.

[0277] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0278] In one application, observing 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 the tissue coupled to the native heart valve annulus by observing movement of the annulus marking device in response to movement of the tissue.

[0279] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0280] In one application, an implant guide device includes a plurality of radiopaque filaments coupled to the implant guide device, and the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0281] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0282] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0283] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0284] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0285] According to some applications, a method is also provided that includes placing an annulus marking device including an annular wire at the surface of the native heart valve annulus of an object, the annular wire including a radiopaque material, facilitating imaging of the heart valve annulus by imaging movement of at least a portion of the wire along the perimeter of the surface of the native heart valve annulus, and in combination with the placement, implanting an implant along the native heart valve annulus of the object using the wire as a guide for implanting the implant under imaging along the annulus. The method may also include retrieving the annulus marking device after the implanting.

[0286] In one application, implanting under imaging includes implanting using fluoroscopy.

[0287] In one application, placing the annulus marking device includes advancing the annulus marking device along an implantation path upstream of the implant.

[0288] In one application, placing includes placing the annulus marking device at the surface of the native mitral valve. In one application, placing includes placing the annulus marking device at the surface of the native tricuspid valve.

[0289] In one application, placing includes pushing a first portion of the annulus marking device against a first portion of the annulus of the valve and thereby pushing a second portion of the annulus marking device opposite the first portion of the annulus marking device against a second portion of the annulus of the valve.

[0290] In one application, implanting the implant includes implanting the implant at the outer perimeter of the annulus marking device in response to the pushing.

[0291] In one application, the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus under imaging of the annulus marking device.

[0292] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0293] In one application, observing 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 coupled to the native heart valve annulus by observing movement of the annulus marking device in response to movement of the tissue.

[0294] In one application, imaging the annulus marking device is performed with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus, including tissue of at least one leaflet and tissue of the atrial wall with respect to the tissue of the native heart valve annulus.

[0295] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled thereto, and the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0296] In one application, imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0297] In one application, imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0298] In one application, imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device with respect to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus, including tissue of at least one leaflet and tissue of the atrial wall with respect to the tissue of the native heart valve annulus.

[0299] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0300] According to some applications, a method is also provided that includes deploying an annulus marking device including a plurality of radiopaque pins within the tissue of the native heart valve annulus of an object, the plurality of radiopaque pins including a radiopaque material, facilitating imaging of the heart valve annulus by imaging the plurality of pins, and subsequently implanting the implant along the native heart valve annulus of the object using the plurality of pins as a guide for implanting the implant along the annulus under imaging.

[0301] In one application, each of the plurality of pins has barbs configured to anchor to the tissue of the annulus.

[0302] In one application, each of the plurality of pins has a longest width of 0.5 mm - 3.0 mm.

[0303] In one application, facilitating imaging of the cardiac valve annulus by imaging the plurality of pins includes facilitating imaging of movement of the plurality of pins in response to movement of the annulus.

[0304] In one application, implanting the implant includes deploying a plurality of tissue anchors to secure the implant to tissue of the annulus.

[0305] In one application, deploying the plurality of tissue anchors includes deploying a greater number of tissue anchors than the number of pins.

[0306] The method can be performed based on a live animal or based on a simulation (such as on a cadaver, cadaver heart, simulator (e.g., having body parts, tissues, etc. being simulated), etc.).

[0307] According to some applications, there is also provided a method including positioning an annulus marker device including a plurality of radiopaque pins within tissue of a native cardiac valve annulus of a native cardiac valve of an object, the plurality of radiopaque pins moving proximally and distally in response to changes in the topography of the tissue of the valve, facilitating imaging of the cardiac valve annulus and tissue coupled to the cardiac valve annulus by moving the plurality of pins along the native cardiac valve and imaging the plurality of pins to generate an image of the topography of the cardiac valve, and implanting the implant along the native cardiac valve annulus of the object using the image as a guide for implanting along the annulus under imaging. The method can also include retrieving the plurality of radiopaque pins from the object.

[0308] In one application, retrieving includes retrieving after the implant. In one application, retrieving includes retrieving before the implant.

[0309] In one application, facilitating imaging of the cardiac valve annulus by imaging the plurality of pins includes facilitating imaging of movement of the plurality of pins in response to movement of the annulus. In one application, implanting includes implanting during facilitation of the imaging. In one application, facilitating imaging includes observing proximal movement of the plurality of pins in response to movement of the plurality of pins over a peak in tissue of the annulus.

[0310] In one application, facilitating imaging includes observing 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 the annulus, and observing that at least a second portion of the plurality of pins does not move in response to movement of the plurality of pins over tissue of the atrial wall.

[0311] The method can be performed based on a live animal or based on a simulation (such as on a cadaver, cadaver heart, simulator (e.g., having body parts, tissues, etc. being simulated), etc.).

[0312] In some applications, there is also provided a system and / or device for use with an object, the system / device including a multi-lumen tube and at least a first annulus marking device that is expandable from within the multi-lumen tube.

[0313] In some applications, at least the first annulus marking device includes a distal frame wire that has an expanded shape in which it presents a generally linear configuration when the annulus marking device is in an expanded state. In some applications, at least the first annulus marking device includes a plurality of radiopaque filaments that are coupled to the distal frame wire, the plurality of radiopaque filaments including a radiopaque material and protruding away from the distal frame wire in the expanded state of the annulus marking device.

[0314] In some applications, at least one central rod is coupled to an intermediate portion of the distal frame wire and is disposed primarily within a main lumen of the multi-lumen tube and is slidable within the main lumen of the multi-lumen tube, the central rod being configured to constrain the distal frame wire and the plurality of radiopaque filaments from the expanded state of the annulus marking device and to pull the distal frame wire and the plurality of radiopaque filaments into the main lumen of the multi-lumen tube.

[0315] In some applications, at least two peripheral wires are coupled to the distal frame wire at their opposite ends, the at least two peripheral wires being disposed primarily within respective secondary lumens of the multi-lumen tube and being slidable within the respective secondary lumens of the multi-lumen tube, the at least two peripheral wires being configured to stabilize the distal frame wire in the expanded state of the annulus marking device.

[0316] In some applications, the annulus marking device can be compressed during delivery toward the native heart valve and can be expanded from the compressed state to be positioned along the native heart valve annulus.

[0317] In some applications, the system / device further includes an implant for implantation along the native heart valve annulus of the object, and the annulus marking device is configured to provide guidance for implantation of the implant along the annulus during implantation.

[0318] In some applications, the annulus marking device can be retrieved after implantation of the implant.

[0319] 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.

[0320] In one application, the perimeter wire is configured to follow behind the distal frame wire as the central rod pulls the distal frame wire and the plurality of radiopaque filaments into the main lumen of the multi-lumen tube.

[0321] In one application, each of the plurality of radiopaque filaments and the distal frame wire comprises a flexible material.

[0322] In one application, at least a first annulus marker device comprises at least first and second annulus marker devices, the multi-lumen tube is shaped to define first and second main lumens, and the multi-lumen tube is shaped to define four secondary lumens.

[0323] In some applications, the device comprises first and second central rods configured to constrain the first and second annulus marker devices respectively within corresponding first and second main lumens. In some applications, the device comprises four perimeter wires configured to stabilize respectively the distal frame wires of the corresponding first and second annulus marker devices, the four perimeter wires being slidable within four secondary lumens.

[0324] In one application, the first and second annulus marker devices are controllable independently by corresponding first and second control rods.

[0325] In one application, at least a first annulus marker device comprises first, second, third and fourth annulus marker devices, the multi-lumen tube is shaped to define first, second, third and fourth main lumens, the multi-lumen tube is shaped to define eight secondary lumens, the device comprises first, second, third and fourth central rods configured to constrain the first, second, third and fourth annulus marker devices respectively within corresponding first, second, third and fourth main lumens, and the device comprises eight perimeter wires configured to stabilize respectively the distal frame wires of the corresponding first, second, third and fourth annulus marker devices, the eight perimeter wires being slidable within eight secondary lumens.

[0326] In one application, the first, second, third and fourth annulus marker devices are controllable independently by corresponding first, second, third and fourth control rods.

[0327] According to some applications, a method is also provided, comprising delivering a distal portion of a central multi-lumen tube into a heart chamber of an object, expanding at least a first annulus marker device from within the multi-lumen tube, and implanting the implant along the native heart valve annulus of the object using the annulus marker device as a guide for implanting the implant under imaging. The method may comprise retrieving the annulus marker device after the implant.

[0328] In some applications, at least the first annulus marker device includes a distal frame wire, and when the annulus marker device is in an expanded state, the distal frame wire has an expanded shape in which it presents a generally linear configuration. 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 marker device.

[0329] In some applications, the method includes controlling the orientation of at least the first annulus marking device by sliding at least one center rod through a main sub-lumen of the multi-lumen tube, wherein the at least one center rod is coupled to a middle portion of the distal frame wire and is primarily disposed within the main sub-lumen of the multi-lumen tube.

[0330] In some applications, the method includes stabilizing the distal frame wire by at least two peripheral wires, wherein the at least two peripheral wires are coupled to the distal frame wire at their opposite ends, the at least two peripheral wires are mainly disposed in corresponding secondary sub-lumens of the multi-lumen tube and can slide in corresponding secondary sub-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 valve ring marking device.

[0331] In some applications, the method includes constraining the annulus marking device by pulling the central rod to constrain the distal frame wire and the plurality of radiopaque filaments from the expanded state of the annulus marking device, and by the pulling, pulling the distal frame wire and the plurality of radiopaque filaments into the main sub-lumen of the multi-lumen tube.

[0332] In some applications, the annulus marker device can be compressed during delivery toward the native heart valve and can be expanded from the compressed state to be positioned along the native heart valve annulus;

[0333] In one application, the multi-lumen tube is shaped to define a central lumen, and the method further comprises delivering the implant to the heart valve annulus via the central lumen.

[0334] In one application, constraining the annulus marking device by pulling the central rod includes allowing the peripheral wire to follow behind the distal framework wire as the central rod pulls the distal framework wire and the plurality of radiopaque filaments into the main sub-lumen of the multi-lumen tube.

[0335] In one application, each of the plurality of radiopaque filaments and the distal framework wire comprises a flexible material.

[0336] In one application, controlling the orientation of at least a first annulus marker device includes placing at least the first annulus marker device along the annulus of the mitral valve.

[0337] In one application, controlling the orientation of at least a first annulus marker device includes placing at least the first annulus marker device along the annulus of the tricuspid valve.

[0338] In one application, the at least first annulus marker device includes at least first and second annulus marker devices, the multi-lumen tube is shaped to define first and second main lumens, the multi-lumen tube is shaped to define four secondary lumens, and the method further includes constraining the first and second annulus marker devices within the corresponding first and second main lumens respectively by pulling corresponding first and second control rods. In some applications, the method further includes stabilizing the wires of the corresponding first and second annulus marker devices respectively using four peripheral wires slidable within the four secondary lumens.

[0339] In one application, the method further includes independently controlling the first and second annulus marker devices using corresponding first and second control rods.

[0340] In one application, the at least first annulus marker device includes first, second, third, and fourth annulus marker devices, the multi-lumen tube is shaped to define first, second, third, and fourth main lumens, the multi-lumen tube is shaped to define eight secondary lumens, and the method further includes constraining the first, second, third, and fourth annulus marker devices within the corresponding second, third, and fourth main lumens respectively by pulling corresponding first, second, third, and fourth control rods. In some applications, the method further includes stabilizing the distal frame wires of the corresponding second, third, and fourth annulus marker devices respectively using eight peripheral wires slidable within the eight secondary lumens.

[0341] The method may further include independently controlling the first, second, third, and fourth annulus marker devices using corresponding first and second control rods.

[0342] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using a plurality of radio-opaque filaments.

[0343] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of radio-opaque filaments against the tissue.

[0344] In one application, imaging the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the plurality of radiopaque filaments in response to movement of the tissue.

[0345] In one application, imaging the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0346] The method may be performed on a live animal or based on a simulation (such as on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0347] According to some applications, a method is also provided that includes placing an annulus marking device at the native heart valve annulus of an object, the annulus marking device including a radiopaque material shaped to define a plurality of expandable fingers, the annulus marking device being in a compressed state during delivery toward the native heart valve and expandable from the compressed state to be positioned along the native heart valve annulus, and implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging. The method may include retrieving the annulus marking device after the implant.

[0348] 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 the lumen of the tool, the annulus marking device surrounding the lumen.

[0349] In one application, placing the annulus marking device includes measuring the height of the annulus using the annulus marking device.

[0350] In one application, implanting under imaging includes implanting using fluoroscopy.

[0351] In one application, retrieving the annulus marking device after the implant includes deflating the annulus marking device and constraining the annulus marking device within a tool and removing the annulus marking device from the object.

[0352] In one application, placing includes placing the annulus marking device along the annulus of the mitral valve. In one application, placing includes placing the annulus marking device along the annulus of the tricuspid valve.

[0353] In one application, using the annulus marking device as the guide for implantation includes observing the shape of each of the plurality of fingers.

[0354] In one application, observing the shape includes determining the annulus marking device at the annulus in response to observing a bend in at least one of the plurality of fingers.

[0355] In one application, observing the shape includes determining the annulus marking device at at least a portion of the leaflet in response to observing movement of at least one of the plurality of fingers in response to movement of at least one of the plurality of fingers.

[0356] In one application, the method further includes inflating the plurality of fingers prior to the placement. In one application, inflating includes inflating the plurality of fingers with a radiopaque fluid.

[0357] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus under imaging of the plurality of fingers.

[0358] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the plurality of fingers relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of fingers against the tissue.

[0359] In one application, observing the tissue of the native heart valve annulus includes imaging the plurality of fingers relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the plurality of fingers in response to movement of the tissue.

[0360] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0361] The method can be performed based on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0362] According to some applications, there is also provided a system and / or device for use with an object, the system / device including an annulus marking device, the annulus marking device including a radiopaque material shaped to define: (1) a plurality of concentric wire loops connected by a gantry and configured to be placed at the orifice of the native heart valve of the object; and (2) a wire loop frame coupled to the gantry and concentric with the plurality of concentric wire loops, the wire loop frame configured to be placed along at least a portion of the circumference of the annulus of the native heart valve.

[0363] In some applications, the annulus marking device may be compressed during delivery toward the native heart valve and may expand from the compressed state to be positioned within the native heart valve.

[0364] In some applications, the system / device further includes an implant for implantation along the annulus of the valve of the object.

[0365] In some applications, the annulus marking device is configured to provide a guide for implanting the implant along the annulus and within the space defined by the frame. In some applications, the annulus marking device may be retrieved after implantation of the implant.

[0366] In one application, the annulus marking device includes a superelastic material. In one application, the plurality of concentric wire loops, the gantry, and the wire loop frame are manufactured as a single piece.

[0367] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to at least the plurality of concentric wire loops, each of the plurality of filaments configured to sway in response to movement of blood through the orifice of the valve to provide an indication of the position of the leaflets of the valve.

[0368] In one application, the annulus marking device includes a locking ring at the center of the plurality of concentric wire loops, the locking ring being pushable distally to lock the annulus marking device in the expanded state.

[0369] 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.

[0370] In one application, the plurality of radiopaque filaments are configured to provide an indication of the position of the leaflets of the valve by moving in response to movement of the native heart valve.

[0371] According to some applications, a method is also provided that includes placing an annulus marking device at a native heart valve of an object, the annulus marking device including a radiopaque material shaped to define: (1) a plurality of concentric wire loops connected by a gantry; and (2) a wire loop frame coupled to the gantry and concentric with the plurality of concentric wire loops, the wire loop frame configured to be placed along at least a portion of the circumference of the annulus of the native heart valve.

[0372] In some applications, the annulus marking device is compressible to a compressed state during delivery toward the native heart valve and expandable from the compressed state to an expanded state for positioning within the native heart valve.

[0373] In some applications, the method includes, under imaging, using the annulus marking device as a guide for implanting an implant along the annulus and within a space defined by the frame, implanting the implant along the annulus. In some applications, the method includes retrieving the annulus marking device after the implant.

[0374] In one application, the method further includes locking the annulus marking device in the expanded state by pushing distally a locking ring disposed at the center of the plurality of concentric wire loops.

[0375] In one application, the method further includes transitioning the annulus marking device from the compressed state to the expanded state by pushing distally a locking ring disposed at the center of the plurality of concentric wire loops.

[0376] In one application, implanting under imaging includes implanting using fluoroscopy.

[0377] In one application, placing includes placing the annulus marking device at the mitral valve, placing the plurality of concentric wire loops at the orifice of the valve, and placing the wire loop frame along at least a portion of the circumference of the annulus of the mitral valve.

[0378] In one application, placing includes placing the annulus marking device at the tricuspid valve, placing the plurality of concentric wire loops at the orifice of the valve, and placing the wire loop frame along at least a portion of the circumference of the annulus of the tricuspid valve.

[0379] In one application, retrieving the annulus marking device after the implant includes sliding the frame around the implant and proximally away from the annulus.

[0380] In one application, the method further includes using the annulus marking device to observe tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0381] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0382] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the annulus marking device in response to movement of the tissue.

[0383] In one application, the annulus marking device includes a plurality of radiopaque filaments coupled to the plurality of concentric wire loops, and the method further includes determining that the annulus marking device is at least at a portion of a leaflet in response to observing movement of at least some of the plurality of radiopaque filaments in response to movement of the valve.

[0384] In one application, the method further includes determining that the annulus marking device is at least at a portion of the annulus in response to observing that a first radiopaque filament of the plurality of radiopaque filaments does not move while a second portion of the plurality of radiopaque filaments moves in response to movement of the valve.

[0385] In one application, retrieving the annulus marking device after the implantation includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

[0386] In one application, retrieving the annulus marking device includes transitioning the annulus marking device from the expanded state to the compressed state by pulling proximally on a locking loop disposed at the center of the plurality of concentric wire loops.

[0387] The method can be performed based on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0388] According to some applications, a method is also provided that includes placing an annulus marking device at the native heart valve annulus of an object, the annulus marking device including a radiopaque material that is shaped to define a plurality of radiopaque leaflets or rings, the annulus marking device being in a compressed state during delivery toward the native heart valve and expandable from the compressed state to be positioned along the native heart valve annulus, and implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging. The method may include retrieving the annulus marking device after the implanting.

[0389] 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 the lumen of the tool, the annulus marking device surrounding the lumen.

[0390] In one application, placing the annulus marking device includes measuring the height of the annulus using the annulus marking device.

[0391] In one application, implanting under imaging includes implanting using fluoroscopy.

[0392] In one application, retrieving the annulus marking device after the implanting includes constraining the annulus marking device within a tool and removing the annulus marking device from the object.

[0393] In one application, placing includes placing the annulus marking device along the annulus of the mitral valve.

[0394] In one application, placing includes placing the annulus marking device along the annulus of the tricuspid valve.

[0395] In one application, at least one of the plurality of leaflets or rings is a larger leaflet or ring than the other leaflets or rings, and placing includes placing the annulus marking device in the valve in a manner such that the larger leaflet or ring is positioned between the leaflets of the valve.

[0396] In one application, using the annulus marking device as the guide for implanting includes observing the shape of each of the plurality of leaflets or rings.

[0397] In one application, observing the shape includes determining the annulus marking device at the annulus in response to observing a bend in at least one of the plurality of leaflets or rings.

[0398] In one application, observing the shape includes determining the annulus marking device at at least a portion of the leaflets in response to movement of at least one of the plurality of leaflets or rings in response to movement of the at least one of the plurality of leaflets or rings.

[0399] In one application, the method further includes observing tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus under imaging of the plurality of leaflets or rings.

[0400] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the plurality of leaflets or rings relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the plurality of leaflets or rings against the tissue.

[0401] In one application, observing the tissue of the native heart valve annulus includes imaging the plurality of leaflets or rings relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the plurality of leaflets or rings in response to movement of the tissue.

[0402] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0403] The method may be performed based on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0404] According to some applications, a system and / or device is also provided, including a guidewire having a distal portion configured to assume a shape in an extended state of the guidewire; and an annulus marking device including a plurality of radiopaque filaments coupled to the distal portion of the guidewire.

[0405] In one application, each of the plurality of radiopaque filaments includes a flexible material.

[0406] In one application, the device further includes a tube, and in the extended state of the guidewire, the distal portion of the guidewire at least partially surrounds a portion of the tube.

[0407] In one application, the device further includes an implant deliverable through the lumen of the tube, and the plurality of radiopaque filaments are configured to guide implantation of the implant.

[0408] According to some applications, a method is also provided, including positioning a distal portion of a guidewire within a chamber of an object's heart, the guidewire being configured to assume a shape in an extended state of the guidewire, and the distal portion of the guidewire being coupled to an annulus marker device including a plurality of radiopaque filaments; and moving the distal portion of the guidewire along tissue surrounding the chamber of the heart; and imaging the tissue surrounding the chamber of the heart by observing the movement of the distal portion of the guidewire and by observing the plurality of radiopaque filaments.

[0409] In one application, moving the distal portion of the guidewire along tissue includes measuring a height of a native annulus of a valve of the heart using the annulus marker device.

[0410] In one application, imaging includes imaging using fluoroscopy.

[0411] In one application, positioning the distal portion of the guidewire includes positioning the distal portion of the guidewire along the annulus of the mitral valve. In one application, positioning the distal portion of the guidewire includes positioning the distal portion of the guidewire along the annulus of the tricuspid valve.

[0412] In one application, positioning the end portion of the guidewire includes positioning the distal portion of the guidewire within a subannular space of a native heart valve of the object.

[0413] In one application, imaging the tissue surrounding the chamber includes observing tissue of a native heart valve annulus and tissue coupled to the native heart valve annulus using the plurality of radiopaque filaments.

[0414] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the plurality of radiopaque filaments against the tissue.

[0415] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of an atrial wall.

[0416] In one application, the method further includes implanting an implant along a native heart valve annulus of the object using the annulus marker device as a guide for implanting the implant under imaging along the annulus. In one application, the method includes retrieving the annulus marker device after the implanting.

[0417] In one application, the implant is delivered through a tube, the distal portion of the guidewire surrounds a portion of the tube, and implanting the implant along the native heart valve annulus of the subject includes guiding the portion of the tube along the annulus using the annulus marking device.

[0418] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0419] According to some applications, a method is also provided that includes expanding an annulus marking device including a radiopaque material within an atrium of a subject's heart, the radiopaque material being shaped to define: (1) a first radiopaque ring, and (2) a second radiopaque ring, the second radiopaque ring being configured to pivot and tilt relative to the first radiopaque ring. The method can include tilting the second radiopaque ring relative to the first radiopaque ring and allowing the second radiopaque ring to pivot in a plane at a non-zero angle relative to the plane of the first radiopaque ring.

[0420] In some applications, the method includes positioning at least a portion of the annulus marking device in its fully expanded state within the native heart valve of the heart such that: (1) the first radiopaque ring is disposed between the leaflets of the native heart valve, an upper portion of the first radiopaque ring is disposed within the atrium, and a lower portion of the first radiopaque ring is disposed within the ventricle of the heart, and (2) the second radiopaque ring is disposed along the atrial surface of the annulus of the valve.

[0421] In some applications, the annulus marking device is compressible to a compressed state during delivery toward the native heart valve and is expandable from the compressed state to the expanded state for positioning within the native heart valve, and the implant is implanted along the annulus using the annulus marking device as a guide for implanting the implant under imaging along the annulus. In some applications, the method includes retrieving the annulus marking device after the implant.

[0422] In one application, implanting under imaging includes implanting using fluoroscopy.

[0423] In one application, positioning includes positioning the annulus marking device at the mitral valve. In one application, positioning includes positioning the annulus marking device at the tricuspid valve.

[0424] In one application, retrieving the annulus marking device after the implant includes pivoting and tilting the second radiopaque ring relative to the first radiopaque ring.

[0425] In one application, positioning includes positioning the first radiopaque ring between the leaflets, and by this positioning, applying a force to the commissures of the valve through the first radiopaque ring.

[0426] In one application, each of the first radiopaque ring and the second radiopaque ring includes a wire frame at least partially surrounded by a respective radiopaque spring, and positioning the annulus marking device includes allowing the spring to compress and expand.

[0427] In one application, retrieving the annulus marking device after the implantation includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

[0428] In one application, the method further includes using the annulus marking device to observe the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus.

[0429] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0430] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the movement of the annulus marking device in response to the movement of the tissue.

[0431] In one application, the method further includes, in the fully expanded state of the annulus marking device, vertically moving the second radiopaque ring along a portion of the first radiopaque ring.

[0432] In one application, vertically moving the second radiopaque ring along a portion of the first radiopaque ring includes measuring the height of the annulus.

[0433] The method can be performed based on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0434] According to some applications, a system and / or device is also provided, including an annulus marking device, the annulus marking device including: a central strut; two or more expandable wires, the two or more expandable wires being connected to the central strut at their respective proximal and distal ends, the two or more expandable wires each being shaped to define a recessed section to fit the native cardiac valve annulus of the object's valve; and at least one ultrasound transducer, the at least one ultrasound transducer being slidable along the central strut and rotatable relative to the central strut. In some applications, the annulus marking device is compressible to a compressed state during delivery toward the native cardiac valve and is expandable from the compressed state to an expanded state for positioning within the native cardiac valve.

[0435] In one application, the device further includes an implant, the implant being implantable at the annulus using the annulus marking device under the guidance from imaging.

[0436] In one application, the central strut is hollow and the at least one ultrasound transducer is disposed within the central strut.

[0437] In one application, the device further includes at least one radiopaque marker, the at least one radiopaque marker being slidable along the two or more expandable elements until the radiopaque marker abuts the annulus.

[0438] In one application, the at least one radiopaque marker includes a wire loop.

[0439] In one application, the at least one radiopaque marker includes a plurality of radiopaque filaments coupled to the wire loop.

[0440] According to some applications, a method is also provided, including expanding an annulus marking device within the native cardiac valve of an object, the annulus marking device being shaped to define two or more expandable wires, the two or more expandable wires being connected to a central strut at their respective proximal and distal ends, the two or more expandable wires each being shaped to define a recessed section to fit the native cardiac valve annulus of the valve.

[0441] In some applications, the annulus marking device is compressible to a compressed state during delivery toward the native cardiac valve and is expandable from the compressed state to an expanded state for positioning within the native cardiac valve.

[0442] In some applications, the method includes sliding at least one ultrasonic transducer rotatably along and relative to the central strut, imaging the annulus of the valve using the ultrasonic transducer, and implanting the implant along the annulus using the annulus marking device as a guide for implanting the implant along the annulus under the imaging. In some applications, the method includes retrieving the annulus marking device after the implantation.

[0443] In one application, the imaging includes measuring the height of the annulus.

[0444] In one application, the expanding includes expanding the annulus marking device at the mitral valve.

[0445] In one application, the expanding includes expanding the annulus marking device at the tricuspid valve.

[0446] In one application, the expanding includes expanding the two or more expandable wires between the leaflets of the valve, and by the expansion, applying a force to the commissure of the valve through the two or more expandable wires.

[0447] In one application, retrieving the annulus marking device after the implantation includes constraining the annulus marking device within a tool and removing the annulus marking device from the subject.

[0448] In one application, the expanding includes positioning the annulus marking device within the native heart valve of the heart in such a way that the two or more expandable wires are disposed between the leaflets of the native heart valve, an upper portion of each expandable wire is disposed within the atrium, and a lower portion of each expandable wire is disposed within the ventricle.

[0449] In one application, the method further includes:

[0450] Vertically sliding a radiopaque marker along the two or more expandable elements until the radiopaque marker abuts the annulus; and

[0451] Imaging the annulus under fluoroscopy.

[0452] In one application, sliding the radiopaque marker includes measuring the height of the annulus.

[0453] In one application, the method further includes using the annulus marking device to observe the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus.

[0454] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0455] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the annulus marking device in response to movement of the tissue.

[0456] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0457] According to some applications, a method is also provided that includes positioning an annulus marking device including a clip in a ventricle of a heart of an object, the clip including: a radiopaque material, first and second jaws, and first and second filaments, the first and second jaws being coupled together at a hinge point, each of the first and second jaws having an end, and the first and second filaments extending from respective ends of the first and second jaws.

[0458] The method can include using the clip to clamp together first and second leaflets of a heart valve of the object, and by the clamping, allowing the first filament to abut an atrial surface of at least one of the first and second leaflets in a manner in which an end of the first filament is positioned near a hinge of the annulus of the valve near an atrial wall, and the second filament to abut a ventricular surface of the at least one of the first and second leaflets in a manner in which an end of the second filament is positioned in a subannular groove of the valve near a ventricular wall.

[0459] The method can further include implanting an implant along the native heart valve annulus of the object using the annulus marking device as a guide for implanting the implant under imaging along the annulus.

[0460] In one application, the method further includes retrieving the annulus marking device after the implanting.

[0461] In one application, the first and second filaments include a superelastic material.

[0462] In one application, the clamping includes implanting the annulus marking device.

[0463] In one application, implanting includes securing at least one of the first and second filaments to the valve.

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

[0465] In one application, positioning the annulus marker device in the ventricle includes positioning the annulus marker device in the right ventricle, and clamping the leaflets together includes clamping the leaflets of the tricuspid valve. In one application, positioning the annulus marker device in the ventricle includes positioning the annulus marker device in the left ventricle, and clamping the leaflets together includes clamping the leaflets of the mitral valve.

[0466] In one application, clamping includes forming a double orifice of the mitral valve.

[0467] In one application, the method further includes observing tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus using the first and second filaments.

[0468] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the first and second filaments against the tissue.

[0469] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing movement of the first and second filaments in response to movement of the tissue.

[0470] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0471] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0472] According to some applications, a method is also provided that includes positioning an annulus marking device that includes a clamping member within a ventricle of a subject's heart, the clamping member including a radiopaque material, first and second arms, and first and second bending elements, the first and second arms being coupled together at a hinge point, each of the first and second arms having an end, and the first and second bending elements being coupled to respective ends of the first and second arms.

[0473] The method may further include using the clamping member to clamp leaflets of the subject's heart valve between the first and second arms, and upon such clamping, allowing: the first bending element to abut an atrial surface of the leaflet near a hinge of the annulus of the valve near an atrial wall; and the second bending element to abut a ventricular surface of the leaflet within a subannular groove of the valve near a ventricular wall.

[0474] The method may further include 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.

[0475] In one application, the method further includes retrieving the annulus marking device after the implanting.

[0476] In one application, implanting under imaging includes implanting using fluoroscopy.

[0477] In one application, positioning the annulus marking device within the ventricle includes positioning the annulus marking device within the right ventricle, and clamping includes clamping leaflets of the tricuspid valve.

[0478] 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.

[0479] In one application, the method further includes observing tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus using the first and second bending elements.

[0480] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the first and second bending elements against the tissue.

[0481] In one application, imaging the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the first and second bending elements in response to movement of the tissue.

[0482] In one application, imaging the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0483] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator with a body part, tissue, etc. being simulated, etc.).

[0484] According to some applications, there is also provided a method including delivering an annulus marking device including a balloon into a native heart valve of a subject's heart and implanting the implant along the native heart valve annulus of the subject using the annulus marking device as a guide for implanting the implant under imaging.

[0485] The balloon can be the same as or similar to other inflatable elements and / or balloons described herein. In some applications, the balloon includes an upper inflatable section, a lower inflatable section, and a central waist between the upper inflatable section and the lower inflatable section, the upper inflatable section being inflatable to present a generally paddle-like shape and the lower inflatable section being inflatable to present a spherical shape.

[0486] 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.

[0487] In some applications, the method includes inflating the balloon such that the upper inflatable section expands to present a generally paddle-like shape and the lower inflatable section expands to present a spherical shape.

[0488] In one application, implanting includes implanting the implant between the outer surface of the upper inflatable element and the atrial wall of the heart.

[0489] In one application, the method further includes retrieving the annulus marking device after the implanting.

[0490] In one application, the upper surface of the upper inflatable section is inclined.

[0491] In one application, implanting under imaging includes implanting using fluoroscopy.

[0492] In one application, the balloon is shaped to define an hourglass shape at at least one of its cross-sections.

[0493] In one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in the mitral valve. In one application, positioning the annulus marking device in the valve includes positioning the annulus marking device in the tricuspid valve.

[0494] In one application, the upper expandable section is less compliant than the lower expandable section. In one application, the upper expandable section is non-compliant.

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

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

[0497] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the upper and lower expandable elements against the tissue.

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

[0499] The method can be performed based on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0500] According to some applications, there is also provided a method including delivering an annulus marking device including a balloon into a ventricle of a native heart valve of a subject's heart, inflating the balloon in the ventricle, and implanting an implant along the subject's native heart valve annulus using the annulus marking device as a guide for implanting under imaging. In some applications, the method includes retrieving the annulus marking device after the implant.

[0501] In one application, inflating includes inflating the balloon such that it assumes a spherical shape. In one application, inflating includes inflating the balloon such that it assumes an annular shape.

[0502] In one application, implanting under imaging includes implanting using fluoroscopy.

[0503] In one application, delivering the annulus marker device within the ventricle includes positioning the annulus marker device in the left ventricle. In one application, delivering the annulus marker device within the ventricle includes positioning the annulus marker device in the right ventricle.

[0504] In one application, the balloon includes a magnetic material within the space defined by the balloon, and implanting under imaging includes attracting the magnetic material to the upper surface of the balloon and marking the annulus of the valve from the ventricular surface of the valve.

[0505] In one application, delivering the annulus marker device includes delivering the annulus marker device using a delivery tool that includes a magnet, and attracting the magnetic material to the upper surface of the balloon includes using the magnet of the delivery tool.

[0506] In one application, the magnet includes a circular magnet, delivering the annulus marker device using the delivery tool includes positioning the magnet at the atrial surface of the valve, and implanting the implant includes implanting the implant between the outer surface of the magnet and the atrial wall.

[0507] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the balloon.

[0508] In one application, the balloon includes a radiopaque material. In one application, inflating the balloon includes inflating the balloon with a radiopaque fluid.

[0509] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the balloon against the tissue.

[0510] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0511] This method can be performed based on a living animal or based on simulation (such as based on a cadaver, a cadaver heart, a simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0512] According to some applications, a method is also provided, including delivering an annulus marking device within a native heart valve of an object's heart, and using the annulus marking device as a guide for implanting an implant along the annulus under imaging and implanting the implant along the native heart valve annulus of the object. The annulus marking device can be the same as or similar to other annulus marking devices described herein.

[0513] In some applications, the annulus marking device includes an upper expandable element and a lower expandable element, the upper expandable element being expandable to present a first annular shape, and the lower expandable element being expandable to present a second annular shape. In some applications, the method includes positioning the annulus marking device such that the upper expandable element is disposed within the atrium of the heart and the lower expandable element is disposed within the ventricle of the heart, and expanding the upper expandable element and the lower expandable element such that the upper expandable element expands to present the first annular shape and the lower expandable element expands to present the second annular shape.

[0514] In one application, implanting includes implanting the implant between the outer surface of the upper expandable element and the atrial wall of the heart.

[0515] In one application, the method further includes retrieving the annulus marking device after the implanting.

[0516] In one application, implanting under imaging includes implanting using fluoroscopy.

[0517] In one application, positioning the annulus marking device within the valve includes positioning the annulus marking device within the mitral valve. In one application, positioning the annulus marking device within the valve includes positioning the annulus marking device within the tricuspid valve.

[0518] 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.

[0519] In one application, the upper and lower expandable elements are discrete.

[0520] In one application, the annulus marking device includes a single balloon, the single balloon including the upper and lower expandable elements coupled together. In one application, the balloon includes a central waist between the upper and lower expandable elements. In one application, the balloon is shaped to define an hourglass shape at at least one of its cross elements.

[0521] In one application, positioning the annulus marker device includes positioning the central waist between the leaflets of the valve.

[0522] In one application, the method further includes using the annulus marker device to visualize tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0523] In one application, the annulus marker device includes a radiopaque material.

[0524] In one application, inflating the annulus marker device includes inflating the annulus marker device with a radiopaque fluid.

[0525] In one application, visualizing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the upper and lower inflatable elements against the tissue.

[0526] In one application, visualizing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0527] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0528] According to some applications, a method is also provided that includes delivering an annulus marker 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 selected from the group consisting of an atrial surface and a ventricular surface, generating a magnetic field around the at least first magnetic element, and using the annulus marker device as a guide for implanting an implant along the annulus of the subject's native heart valve while implanting the implant along the annulus.

[0529] The method can further include retrieving the annulus marker device after the implant.

[0530] 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 member.

[0531] In one application, generating the magnetic field includes preventing movement of the magnetic element relative to the tissue of the valve.

[0532] In one application, generating the magnetic field includes positioning the magnetic element in a suitable orientation relative to the tissue of the valve.

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

[0534] In one application, delivering the annulus marker device includes delivering the annulus marker device to the mitral valve. In one application, delivering the annulus marker device includes delivering the annulus marker device to the tricuspid valve.

[0535] In one application, generating the magnetic field around the at least first magnetic element includes providing an external magnetic field.

[0536] In one application, delivering the annulus marker device includes positioning the at least first magnetic element at the atrial surface, and generating the magnetic field includes generating the magnetic field from within the ventricle of the heart.

[0537] In one application, delivering the annulus marker device includes positioning the at least first magnetic element at the ventricular surface, and generating the magnetic field includes generating the magnetic field from within the atrium of the heart.

[0538] In one application, delivering the at least first magnetic element includes delivering the first magnetic element to the atrial surface of the valve. In one application, the method further includes delivering a second magnetic element to the ventricular surface of the valve, and generating the magnetic field includes generating the magnetic field in response to delivering the second magnetic element.

[0539] In one application, implanting the implant includes implanting the implant between the outer surface of the first magnetic element and the atrial wall.

[0540] In one application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the at least first magnetic element.

[0541] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the first magnetic element against the tissue.

[0542] In one application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0543] The method can be performed on a live animal or based on a simulation (such as based on a cadaver, a cadaver heart, a simulator (e.g., having a body part, tissue, etc. being simulated), etc.).

[0544] According to some applications, a method is also provided that includes placing an annulus marking device including a coiled wire at the surface of the native heart valve annulus of an object, the coiled wire including a radiopaque material, facilitating imaging of the heart valve annulus by imaging movement of at least a portion of the coiled wire along the perimeter of the surface of the native heart valve annulus, and implanting the implant along the native heart valve annulus of the object using the coiled wire as a guide for implanting the implant along the annulus under imaging in combination with the placement. The method may also include retrieving the annulus marking device after the implanting.

[0545] In one application, implanting under imaging includes using fluoroscopy for the implanting.

[0546] In one application, placing includes placing the annulus marking device at the surface of the native mitral valve. In one application, placing includes placing the annulus marking device at the surface of the native tricuspid valve.

[0547] In one application, placing includes (1) anchoring a first end portion 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 portion of the coiled wire to a second commissure of the valve.

[0548] In one application, allowing the coiled wire to expand along the portion of the circumference of the valve includes applying a thrust to a portion of the annulus at the portion of the circumference of the valve.

[0549] In one application, placing includes placing the annulus marking device along the atrial surface of the valve, and (1) anchoring the first end portion of the coiled wire to the first commissure of the valve includes using a first anchor to anchor the first end portion to the first commissure, the first anchor being locked in place at the first commissure in the ventricle of the heart of the object, and (2) anchoring the second end portion of the coiled wire to the second commissure of the valve includes using a second anchor to anchor the second end portion to the second commissure, the second anchor being locked in place at the second commissure in the ventricle of the heart of the object.

[0550] In one application, the valve includes a mitral valve, and (1) anchoring the first end portion of the coiled wire to the first commissure of the valve includes anchoring the first end portion to the anterolateral commissure of the valve, (2) allowing the coiled wire to expand along the portion of the circumference of the valve includes allowing the coiled wire to expand along the posterior circumference of the valve, and (3) anchoring the second end portion of the coiled wire to the second commissure of the valve includes anchoring the second end portion of the coiled wire to the posteromedial commissure of the valve.

[0551] In one application, implanting the implant includes implanting the implant at an outer perimeter of the annulus marking device in response to the pushing.

[0552] In one application, the method further includes observing tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus under imaging of the annulus marking device.

[0553] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the annulus marking device against the tissue.

[0554] In one application, observing 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 the tissue coupled to the native heart valve annulus by observing movement of the annulus marking device in response to movement of the tissue.

[0555] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the annulus marking device relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of an atrial wall.

[0556] The method can be performed based on a living animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0557] According to some applications, there is also provided a method including placing an annulus marking device including a radiopaque material within a native heart valve of a heart of an object, the radiopaque material being shaped to define an expandable element that expands within the heart valve such that the expandable element provides an indication of a location of a native heart valve annulus of the native heart valve of the object.

[0558] In some applications, the annulus marker device may be compressed during delivery toward the native heart valve and may expand from the compressed state to be positioned at least within the heart valve. The method may further include expanding the annulus marker device to an expanded state.

[0559] The method may further include implanting the implant along the native heart valve annulus of the subject using the annulus marker device as a guide for implanting the implant along the annulus under imaging.

[0560] The method may further include retrieving the annulus marker device after the implant.

[0561] In one application, implanting under imaging includes implanting using fluoroscopy.

[0562] In one application, retrieving the annulus marker device after the implant includes constraining the annulus marker device within a tool and removing the annulus marker device from the subject.

[0563] In one application, placement includes placing the annulus marker device in the mitral valve. In one application, placement includes placing the annulus marker device in the tricuspid valve.

[0564] In one application, expanding the expandable device includes expanding the expandable device to present a generally spherical shape, and implanting the implant includes positioning the implant between the annulus marker device and tissue of the atrial wall.

[0565] In one application, the expandable element includes a plurality of expandable elements, the plurality of expandable elements including a plurality of braided radiopaque fabric fibers presenting a mesh.

[0566] In one application, the expandable element includes a plurality of expandable elements, the plurality of expandable elements including a plurality of braided radiopaque metal fibers presenting a mesh.

[0567] In one application, the expandable element includes a balloon.

[0568] In one application, the method further includes observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the annulus marker device.

[0569] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the expandable element relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing the expandable element against the tissue.

[0570] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the expandable element relative to the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus by observing movement of the expandable element in response to movement of the tissue.

[0571] In one application, observing the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus includes imaging the expandable element relative to the tissue of the native heart valve annulus, tissue of at least one leaflet, and tissue of the atrial wall.

[0572] The method can be performed based on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0573] According to one application of the present invention, there is also provided a system for use with an object, the system including an implant and an annulus marking device, the implant being configured to be placed along the native heart valve annulus of the native heart valve of the object.

[0574] In some applications, the implant includes a body portion, the body portion including a flexible material, the body portion having a longitudinal axis that travels along the length of the body portion.

[0575] The annulus marking device is the same as or similar to any annulus marking device described herein. In some applications, the annulus marking device includes a gantry, the gantry including a radiopaque material, the gantry being collapsible and expandable and being configured to laterally abut the tissue of the heart valve when expanded. A plurality of radiopaque elements can be coupled to the gantry, the plurality of radiopaque elements being configured to mark the native heart valve annulus and tissue coupled to the native heart valve annulus.

[0576] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of an anchor along the body portion. In one application, each of the plurality of radiopaque elements includes a flexible material. In one application, each of the plurality of radiopaque elements includes a radiopaque filament.

[0577] In one application, when the gantry expands, the gantry is configured to abut the tissue of the leaflets of the valve in such a way that the leaflets present two sub-tips.

[0578] In one application, the annulus marking device is coupled to a delivery tool, and the annulus marking device can be retrieved when the delivery tool is removed from the object.

[0579] In one application, the scaffold includes at least one strut that has a vertical orientation when the scaffold is expanded. In one application, when the scaffold is expanded, the strut extends from the atrial surface of the heart valve toward the ventricular surface of the heart valve.

[0580] In one application, the plurality of radiopaque elements includes a plurality of radiopaque filaments, and the strut is coupled to the plurality of radiopaque filaments such that when the scaffold is expanded, the plurality of radiopaque filaments are configured to bear against the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus in a manner that the plurality of radiopaque filaments provide an indication of the native heart valve annulus and the tissue coupled to the native heart valve annulus.

[0581] In one application, the at least one strut includes a plurality of struts, and the scaffold includes an expandable basket coupled to the plurality of struts such that the scaffold expands circumferentially relative to the native heart valve in a manner that the plurality of struts are circumferentially disposed relative to the native heart valve.

[0582] In one application, the scaffold includes a central strut, an upper laterally expandable element, and a lower laterally expandable element, the upper laterally expandable element being configured to expand laterally away from the central strut, the lower laterally expandable element being configured to expand laterally away from the central strut; and at least one flexible wire coupled to and extending between the upper laterally expandable element and the lower laterally expandable element, and when the scaffold is expanded, the at least one flexible wire is configured to bear against the tissue of the heart valve.

[0583] In one application, the upper laterally expandable element and the lower laterally expandable element are longitudinally movable relative to the central strut to control the tension of the at least one flexible wire.

[0584] In one application, when the scaffold is expanded, the upper laterally expandable element is configured to be disposed in the atrium of the subject's heart, and the lower laterally expandable element is configured to be disposed in the ventricle of the subject's heart.

[0585] In one application, the upper laterally expandable element includes a first expandable and collapsible ring, the lower laterally expandable element includes a second expandable and collapsible ring, the at least one wire includes at least two wires circumferentially coupled at corresponding positions along the first ring and the second ring, and when the scaffold is expanded, the first ring and the second ring are in an expanded state.

[0586] In one application, the upper laterally expandable element includes a first expandable and collapsible crossbeam that extends laterally away from the central rod, the lower laterally expandable element includes a second expandable and collapsible crossbeam that extends laterally away from the central rod, the at least one wire includes at least two wires coupled at corresponding locations along the first and second crossbeams, and when the scaffold expands, the first and second crossbeams are in an expanded state.

[0587] In one application, the scaffold includes a central rod, a first ring element, a second ring element, at least one curved flexible wire, the first ring element being configured to expand laterally away from the central rod, the second ring element being configured to expand laterally away from the central rod, the at least one curved flexible wire being coupled to and extending from the rod at least within the space defined by the first and second ring elements; and a first magnet, the first magnet being coupled to an end of the flexible wire, the first magnet being movable by a second magnet not coupled to the scaffold. When the scaffold expands, the first and second ring elements are configured to push against the tissue of the heart valve.

[0588] In one application, the first and second ring elements are movable longitudinally relative to the central rod to control the tension of the first and second ring elements.

[0589] In one application, a delivery tool is configured to deliver the implant, the system includes the second magnet, and the delivery tool is coupled to the second magnet.

[0590] In one application, when the scaffold expands, a first half of each of the first and second ring elements is configured to be disposed in the atrium of the subject's heart, and a second half of each of the first and second ring elements is configured to be disposed in the ventricle of the subject's heart.

[0591] In one application, the first and second ring elements include a radiopaque material. In one application, the first and second ring elements are coupled to a radiopaque material.

[0592] In one application, the scaffold includes a central rod, at least one curved flexible wire, and a first magnet, the at least one curved flexible wire being coupled to and extending from the rod, the first magnet being coupled to an end of the flexible wire, the first magnetic element being movable by a second magnetic element not coupled to the scaffold.

[0593] In one application, when the scaffold expands, (1) the at least one curved flexible wire is configured to be disposed within the ventricle of the subject's heart, and (2) the first magnetic element is configured to be disposed within the subannular space of the heart.

[0594] In one application, the at least one curved flexible wire is longitudinally movable relative to the central rod.

[0595] In one application, the second magnetic element is configured to be positioned within the vasculature around the native heart valve.

[0596] 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 comprises a radiopaque material.

[0597] In one application, the gantry includes a central rod, at least one crossbeam, and a first magnetic element, the at least one crossbeam being coupled to the rod and extending laterally therefrom, the first magnetic element being coupled to an end of the at least one crossbeam, the first magnetic element being movable by a second magnetic element not coupled to the gantry.

[0598] In one application, when the gantry is expanded, the at least one crossbeam is configured to be disposed within the atrium of the heart of the subject.

[0599] In one application, the at least one crossbeam is longitudinally movable relative to the central rod.

[0600] In one application, the second magnetic element is configured to be positioned within the vasculature around the native heart valve.

[0601] In one application, the at least one crossbeam is coupled to a radiopaque material. In one application, the at least one crossbeam comprises a radiopaque material.

[0602] According to one application of the present invention, there is also provided a system for use with a subject, the system including an implant and an annulus marking device, the implant being configured for placement along the native heart valve annulus of the native heart valve of the subject, the annulus marking device being discrete from the implant and removable from the subject's body after implantation of the implant. The annulus marking device can be the same or similar to any annulus marking device described herein.

[0603] In some applications, the annulus marking device includes a plurality of radiopaque markers juxtaposed with each other at a given distance from each other, the plurality of radiopaque markers each being deformable by tissue at different intervals, the intervals indicating the proximity of the tissue to the implant.

[0604] In some applications, the implant includes a body portion, the body portion including a flexible material, the body portion having a longitudinal axis extending along the length of the body portion.

[0605] In one application, the plurality of radiopaque markers are sized differently from one another. In one application, the plurality of radiopaque markers include concentric rings. In one application, the plurality of radiopaque markers include concentric flaps or rings. In one application, the plurality of radiopaque markers include a plurality of radiopaque strips.

[0606] In one application, the plurality of radiopaque markers include lines.

[0607] In one application, each of the plurality of radiopaque markers includes a radiopaque sail extending therefrom.

[0608] In one application, each of the plurality of radiopaque markers includes a radiopaque filament extending therefrom.

[0609] According to one application of the present invention, there is also provided a system for use with an object, the system including an implant and an annulus marking device, the implant being configured to be placed along the native cardiac valve annulus of the native heart valve of the object, the annulus marking device including an elongate radiopaque element and a plurality of flexible radiopaque filaments, the plurality of flexible radiopaque filaments being coupled to the elongate radiopaque element and being configured to mark the native cardiac valve annulus and tissue coupled to the native cardiac valve annulus.

[0610] In some applications, the elongate radiopaque element is slidable along the body portion of the implant and along the longitudinal axis, and the plurality of radiopaque filaments.

[0611] In some applications, the implant includes a body portion, the body portion including a flexible material, the body portion having a longitudinal axis extending along the length of the body portion.

[0612] In one application, the annulus marking device is removable from the object after implantation of the implant.

[0613] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of an anchor along the body portion. In one application, each of the plurality of radiopaque filaments includes a flexible material. In one application, the elongate radiopaque element includes a line. In one application, the elongate radiopaque element includes a rod.

[0614] In one application, the plurality of radiopaque filaments are disposed at the distal end of the elongate radiopaque element, the annulus marking device including a tube coupled to the proximal end of the elongate radiopaque element, and the tube surrounding the body portion and sliding relative to the body portion to move the plurality of radiopaque filaments relative to the implant.

[0615] In one application, the plurality of radiopaque filaments are disposed at a distal end of the elongate radiopaque element, the body portion includes a plurality of apertures, and the elongate radiopaque element is slidable relative to the plurality of apertures to move the plurality of radiopaque filaments relative to the implant.

[0616] In one application, the plurality of radiopaque filaments may collapse as they pass through each of the plurality of apertures.

[0617] According to an application of the present invention, there is also 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 flat surface of a leaflet of the valve, and implanting the 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 the implanting.

[0618] The annulus marking device may be the same as or similar to any annulus marking device described herein.

[0619] In some applications, the annulus marking device includes (1) a wire radiopaque extension, and (2) at least one radiopaque distal curved tip disposed at a non-zero angle relative to the wire extension.

[0620] In some applications, the method includes, after the placing, enabling the annulus marking device to move incrementally along the leaflet, and by the movement, changing the delivery angle of the annulus marking device relative to the flat surface of the leaflet of the valve.

[0621] The method may further include, by changing the angle, determining the orientation of the valve annulus by visualizing the change of the angle.

[0622] In one application, determining the position includes determining that the curved distal tip is disposed along the leaflet in response to visualizing the pulsation of the annulus marking device.

[0623] In one application, determining the orientation includes determining that the curved distal tip is disposed at the annulus in response to visualizing that the annulus marking device does not move.

[0624] The method may be performed based on a live animal or based on a simulation (such as based on a cadaver, cadaver heart, simulator (such as a simulator having a body part, tissue, etc. being simulated), etc.).

[0625] In one application according to the present invention, there is also provided a system for use with a subject, the system including an implant and an annulus marking device, the implant being configured to be placed along the native cardiac valve annulus of the subject's native heart valve, the annulus marking device including an expandable radiopaque braided mesh that is expandable from a collapsed state to an expanded state.

[0626] In some applications, the expanded state includes a frustoconical shape. In some applications, two or more pull wires are coupled to the expandable braided mesh, the two or more pull wires being configured to be pulled to transform the braided mesh from the frustoconical shape to a shape in which the mesh presents (1) an inclined upper portion configured to be positioned within the atrium of the subject's heart, (2) a raised convex portion configured to be positioned above the heart valve, (3) a constricted portion for positioning within the heart valve, and (4) a flared portion configured to expand within the ventricle of the subject's heart.

[0627] In some applications, the implant includes a body portion that includes a flexible material and has a longitudinal axis that travels along the length of the body portion.

[0628] In one application, the annulus marking device is removable from the subject after implantation of the implant.

[0629] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of anchors along the body portion.

[0630] In one application, the two or more pull wires include three pull wires.

[0631] In one application, the raised portion has a greater diameter than other portions of the annulus marking device. In one application, the implant is slidable along the inclined upper portion toward the annulus.

[0632] In one application according to the present invention, there is also provided a system for use with a subject, the system including an implant and an annulus marking device, the implant being configured to be placed along the native cardiac valve annulus of the subject's native heart valve. The annulus marking device can be the same as or similar to other annulus marking devices described herein.

[0633] In some applications, the annulus marking device includes an expandable radiopaque braided mesh that is expandable from a collapsed state to an expanded state, in which the mesh presents (1) an inclined upper portion configured to be positioned within the atrium of the heart of the subject, and (2) an asymmetric portion for positioning within the heart valve.

[0634] In one application, the annulus marking device is removable from the subject after implantation of the implant.

[0635] In some applications, the implant includes a body portion that includes a flexible material and has a longitudinal axis that travels along the length of the body portion.

[0636] In one application, the body portion includes a plurality of radiopaque markers configured to indicate placement of the anchor along the body portion.

[0637] In one application, the implant is slidable along the inclined upper portion toward the annulus.

[0638] In one application, the system includes a stabilizing rod and tissue anchors that are coupled to the ends of the stabilizing rod and configured to reversibly couple to the tissue of the heart of the subject, the annulus marking device is slidably coupled to the stabilizing rod, and the stabilizing rod is configured to stabilize and guide the positioning of the annulus marking device.

[0639] In one application, in the expanded state, the mesh presents a flared portion configured to expand within the ventricle of the heart of the subject.

[0640] In one application, the flared portion has a greater diameter than other portions of the annulus marking device.

[0641] In one application, the system includes a plurality of expandable snares that are coupled to the distal portion of the expandable radiopaque braided mesh and configured to snare one or more native leaflets of the native valve of the subject.

[0642] In one application, the plurality of expandable snares includes a rigid material. In one application, the plurality of expandable snares includes a flexible material. In one application, the plurality of expandable snares includes a radiopaque material.

[0643] In one application, the plurality of expandable snares extend distally from the distal end of the expandable radiopaque braided mesh and then curve proximally.

[0644] In one application, the system includes a plurality of expandable radiopaque elements that are coupled to a distal portion of the expandable radiopaque braided mesh and are configured to expand radially such that the plurality of expandable elements provide an indication of the location of the native cardiac valve annulus of the native heart valve of the subject.

[0645] In one application, the plurality of radiopaque expandable elements together form the annulus marking device into a generally spherical shape.

[0646] In one application, the plurality of expandable radiopaque elements include a plurality of braided radiopaque fibers presenting a mesh. In one application, the plurality of expandable radiopaque elements include a plurality of curved lines.

[0647] In one application, the system includes an inflatable annular element coupled to a distal portion of the expandable radiopaque braided mesh, the inflatable annular element being configured to position the expandable radiopaque braided mesh within the native valve of the subject.

[0648] In one application, the inflatable annular element includes a radiopaque material.

[0649] In one application, the inflatable annular element includes a prosthetic valve.

[0650] In one application, the expandable radiopaque braided mesh can be positioned within the native heart valve and the inflatable annular element can be positioned below the native heart valve.

[0651] According to one application of the present invention, there is also provided a system for use with a subject, the system including an implant and an annulus marking device, the implant being configured to be placed along the native cardiac valve annulus of the native heart valve of the subject, the annulus marking device including a temporary valve.

[0652] In some applications, the temporary valve is an inflatable temporary valve that can be inflated from a collapsed state to an inflated state or an expanded state. In some applications, in the expanded state, the inflatable temporary valve includes (1) a proximal non-compliant balloon configured to be positioned within the native heart valve and partially within the atrium of the subject's heart, and (2) a distal compliant balloon configured to be positioned within the subannular space of the native heart valve.

[0653] In one application, two or more prosthetic leaflets are coupled to the temporary valve.

[0654] In some applications, the implant includes a body portion that includes a flexible material and has a longitudinal axis that travels along the length of the body portion.

[0655] In an application according to the present invention, there is also provided a method that includes delivering an annulus marker device that includes 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 the vasculature around the heart valve, generating a magnetic field around the at least first magnetic element; and implanting the implant along the native heart valve annulus of the subject using the annulus marker device as a guide for implanting the implant along the annulus under imaging.

[0656] In some applications, the method further includes retrieving the annulus marker device after the implant.

[0657] In an application, the at least first magnetic element is coupled to a curved wire, and delivering the annulus marker device includes delivering the first magnetic element to the ventricular surface.

[0658] In an application, the at least first magnetic element is coupled to an end of at least one crossbeam, and delivering the annulus marker device includes delivering the first magnetic element to the atrial surface.

[0659] In an application, generating the magnetic field includes positioning the magnetic element at a suitable orientation relative to the tissue of the valve.

[0660] In an application, implanting under imaging includes implanting using fluoroscopy.

[0661] In an application, delivering the annulus marker device includes delivering the annulus marker device to the mitral valve. In an application, delivering the annulus marker device includes delivering the annulus marker device to the tricuspid valve.

[0662] In an application, the method further includes observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus using the at least first magnetic element.

[0663] In an application, observing the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus includes imaging the annulus marker device relative to the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus by observing the first magnetic element against the tissue.

[0664] In one application, imaging of the annulus marking device is performed on the tissue of the native heart valve annulus and tissue coupled to the native heart valve annulus, including the tissue of the native heart valve annulus, the tissue of at least one leaflet, and the tissue of the atrial wall.

[0665] The methods herein and other methods can be performed on live animals or based on simulations (such as on cadavers, cadaver hearts, simulators (such as simulators having body parts, tissues, etc. being simulated), etc.).

[0666] The present invention will be more fully understood from the following detailed description of its embodiments in conjunction with the accompanying drawings, in which: BRIEF DESCRIPTION OF THE DRAWINGS

[0667] Figure 1A - C is a schematic diagram of an example of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications;

[0668] Figure 2A - F is for implantation according to some applications Figure 1A - C is a schematic diagram of a method of an annulus marking device;

[0669] Figure 3A - C is a schematic diagram of an example of a corresponding annulus marking device according to some applications;

[0670] Figure 4A - B is a schematic diagram of an implant including an annulus marking device according to some applications;

[0671] Figure 5A - B is a schematic diagram of an implant including an annulus marking device according to some applications;

[0672] Fig. 6A - B is a schematic diagram of a corresponding tissue anchor including an annulus marking device according to some applications;

[0673] Fig. 7A - C is a schematic diagram of an implant including an annulus marking device according to some applications;

[0674] Fig. 8A - B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications;

[0675] Fig.9A - B is a schematic diagram of a navigation-based guidance system according to some applications, the guidance system employing one or more longitudinal guides configured to facilitate guiding an implant to a specific part of the mitral valve by a guide contacting the surface of the mitral valve;

[0676] Fig. 10A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications;

[0677] Fig.11A -C is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications;

[0678] Fig. 12A -B is a schematic diagram of a system for facilitating imaging of cardiac tissue during the implantation of a cardiac implant for some applications, the system including a mapping catheter;

[0679] Fig.13 is a schematic diagram of an annulus marking device for some applications, the annulus marking device including a generally spherical expandable element for facilitating imaging of cardiac tissue during the implantation of a cardiac implant;

[0680] Fig.14 is a schematic diagram of an annulus marking device according to some embodiments, the annulus marking device including a generally spherical expandable mesh for facilitating imaging of cardiac tissue during the implantation of a cardiac implant;

[0681] Fig.15 is a schematic diagram of a system including an annulus marking device for some applications, the annulus marking device including a guide wire extending alongside the implant for assisting in the implantation of the implant under the guidance of imaging;

[0682] Fig.16A -C is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications;

[0683] Fig.17A -C is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications, the annulus marking device including an expandable element;

[0684] Fig.18 is a schematic diagram of an annulus marking device for use in the ventricle for assisting in the implantation of a cardiac device under the guidance of imaging for some applications;

[0685] Fig.19A -C is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications, the annulus marking device including an expandable element;

[0686] Fig. 20A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging for some applications, the annulus marking device including an annular stent;

[0687] Figure 21-27 Schematic diagrams of corresponding annulus marking devices for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking devices including implant guiding devices;

[0688] Fig.28A -B is a schematic diagram of an annulus marking device for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking device including a plurality of implantable radio-opaque pins;

[0689] Fig.29 Schematic diagrams of annulus marking devices for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking devices including a plurality of radio-opaque pins movable proximally and distally;

[0690] Fig. 30A -B and Fig.31 Schematic diagrams of corresponding annulus marking devices for each of which includes a plurality of radio-opaque filaments deliverable through a multi-lumen tube and assist in the implantation of cardiac devices under the guidance of imaging;

[0691] Fig.32 Schematic diagrams of annulus marking devices for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking devices including expandable elements;

[0692] Fig.33A -B is a schematic diagram of an annulus marking device for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking device including inflatable elements;

[0693] Fig.34A -C is a schematic diagram of an annulus marking device for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking device including concentric wire loops;

[0694] Fig.35 Schematic diagrams of annulus marking devices for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking devices including a plurality of flaps;

[0695] Fig.36 Schematic diagrams of annulus marking devices including a plurality of radio-opaque filaments coupled to the distal portion of a guide wire;

[0696] Fig.37A -G is a schematic diagram of an annulus marking device for assisting in the implantation of cardiac devices under the guidance of imaging, the annulus marking device including first and second radio-opaque rings;

[0697] Fig.38 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes two or more expandable wires and an ultrasonic transducer;

[0698] Fig.39 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a clip;

[0699] Fig.40 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a clamping member;

[0700] Fig.41 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a balloon having upper and lower expandable sections;

[0701] Fig.42 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a balloon;

[0702] Fig.43 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some other applications. The annulus marking device includes a balloon having upper and lower expandable sections;

[0703] Figures 44-46 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to corresponding applications. The annulus marking device includes a magnetic element;

[0704] Fig.47 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a spring;

[0705] Fig.48 It is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes an expandable element;

[0706] Fig.49A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications. The annulus marking device includes a gantry;

[0707] Fig.50A-B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a gantry, the gantry including a rod;

[0708] Fig.51A -C is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a gantry, the gantry including an expandable basket;

[0709] Fig.52A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a plurality of radio-opaque markers;

[0710] Fig.53A -B and Fig.54A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device being coupled to an implant;

[0711] Fig.55A -C is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a radio-opaque guide;

[0712] Fig.56A -C is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a radio-opaque expandable mesh;

[0713] Fig.57A -B, Fig.58A -B, Fig.59A -B, Fig.60A -B and Fig.61A -B is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to a corresponding application, the annulus marking device including a radio-opaque asymmetric mesh;

[0714] Fig.62A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including an inflatable prosthetic valve;

[0715] Fig.63A -B is a schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging, the annulus marking device including a gantry and a magnet; and

[0716] Figure 64-65Schematic diagram of an annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to a corresponding application, the annulus marking device including a magnetic element. Detailed Description

[0717] Now refer to Figure 1A -C, Figure 1A -C is a schematic diagram of a corresponding annulus marking device for assisting in the implantation of a cardiac device under the guidance of imaging according to some applications of the present invention. The manipulation procedure can be performed with the aid of imaging (such as fluoroscopy, transesophageal echo, and / or echocardiography).

[0718] Figure 1A System 20 is shown including an annulus marking device 22, the annulus marking device 22 including a radiopaque material formed to define a base frame 24 having a shape such that it tracks the circumference of the native cardiac valve annulus and approximates the shape of the annulus. That is, the frame 24 has a circular shape that tracks the circumference of the native cardiac valve. Device 22 includes one or more struts 26 (e.g., three shown by way of illustration and not limitation). The struts 26 project away from the plane defined by the base frame 24 and are shaped to be placed in the commissures of the native valve. The struts 26 thus provide an indicator of the position, height, and orientation of the commissures in imaging. The struts 26 are desirably sized and configured to contact tissue near or within the cardiac valve annulus to support the base frame 24 against migration within the annulus. The struts 26 are spaced apart to maintain engagement with tissue at or near the leaflet commissures (or anywhere tissue contact with the struts 26 is expected to occur). For some applications, the frame 24 and the struts 26 are manufactured as a single piece. Optionally, the frame 24 and the struts 26 can be manufactured as separate parts and coupled together, for example, by welding, clamping, etc. The struts 26 can provide an indication of the height of the valve annulus such that when device 22 is placed, the height of the annulus can be measured, for example, by imaging the struts when in contact with the annulus.

[0719] Device 22 can be delivered percutaneously, thoracoscopically through the chest, or using open-heart surgical techniques. To assist in percutaneous delivery and / or for other reasons, device 22 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into the desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods through the femoral vein or jugular vein under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, device 22 includes a wire.

[0720] The device 22 is configured to be placed along the native tricuspid valve. Accordingly, 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 perimeter of the base frame 24. For some applications, the base frame 24 is hollow and shaped to define a lumen, and the adjustment mechanism 28 includes a wire that extends at least partially within the lumen of the base frame 24. In such applications, the wire is pullable and / or twistable to adjust the perimeter of the base frame 24. For some applications, a portion of the base frame 24 is telescopically collapsible in response to pulling of the wire of the adjustment mechanism 28.

[0721] The device 22 may be compressed toward the native heart valve during delivery. During delivery of the device 22, the device 22 is constrained in a folded state. A flexible pusher rod may be used to eject the device 22 from a delivery catheter. In the absence of a catheter, the device 22 will self-expand from its compressed state to its predetermined configuration, e.g., the configuration shown as Figure 1A shown.

[0722] Figure 1B A system 30 is shown that includes an annulus marking device 32 that includes a radiopaque material shaped to define a base frame 34 having a shape such that it tracks the circumference of the native heart valve annulus and approximates the shape of the annulus. That is, the frame 34 has a "D" shape that tracks the circumference of the native heart valve. The device 32 includes one or more struts 36 (e.g., three shown by way of illustration and not limitation). The struts 36 project away from the plane defined by the base frame 34 and are shaped to be placed in the commissures of the native valve. The struts 36 thus provide an indication of the location, height, and orientation of the commissures in imaging. The struts 36 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the base frame 34 against migration within the annulus. The struts 36 are spaced apart to maintain engagement with tissue at or near the leaflet commissures (or anywhere tissue contact with the struts 36 is expected to occur). For some applications, the frame 34 and the struts 36 are manufactured as a single piece or as separate parts that are coupled to one another, as mentioned above with respect to the device 22. Additionally, as mentioned above, the struts 36 may provide an indication of the height of the valve annulus such that when the device 32 is placed, the height of the annulus may be measured, e.g., by imaging the struts when in contact with the annulus.

[0723] The device 32 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. If delivered percutaneously, the device 32 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods accessing the femoral vein or jugular vein under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 32 includes wires.

[0724] The device 32 is configured to be placed along the native mitral valve. Accordingly, the frame 34 of the device 32 is substantially D-shaped, and the struts 36 are relatively spaced apart to fit within the commissures of the native mitral valve. For some applications, the frame 34 of the device 32 is substantially saddle-shaped such that the frame 43 looks like the wavy outer circumferential line of a saddle. For some applications, the device 32 includes an adjustment mechanism 38 for expanding and contracting the perimeter of the base frame 34. For some applications, the base frame 34 is hollow and shaped to define a lumen, and the adjustment mechanism 38 includes a wire that extends at least partially within the lumen of the base frame 34. In such applications, the wire is pullable and / or twistable to adjust the perimeter of the base frame 34. For some applications, a portion of the base frame 34 can telescopically collapse in response to pulling of the wire of the adjustment mechanism 38.

[0725] The device 32 can be compressed toward the native heart valve during delivery. During delivery of the device 32, the device 32 is constrained in a collapsed state. A flexible pusher rod can be used to eject the device 32 from the delivery catheter. In the absence of the catheter, the device 32 will self-expand from its compressed state to its predetermined configuration, e.g., as Figure 1B shown in the configuration.

[0726] Figure 1CSystem 40 is shown including annulus marking device 42, which includes a radiopaque material shaped to define a base frame 44 having a shape such that it tracks the circumference of the native heart valve annulus and approximates the shape of the annulus. That is, frame 44 has a circular shape that tracks the circumference of the native heart valve. Device 42 includes one or more struts 46 (e.g., three shown by way of illustration and not limitation). Struts 46 project away from the plane defined by base frame 44 and are shaped to be placed in the commissures of the native valve. Struts 46 thus provide an indication of the location, height, and orientation of the commissures in imaging. Struts 46 are desirably sized and configured to contact tissue near or within the heart valve annulus to support base frame 44 against migration within the annulus. Struts 46 are spaced apart to maintain engagement with tissue at or near the leaflet commissures (or anywhere tissue contact with struts 46 is expected to occur). For some applications, frame 44 and struts 46 are manufactured as a single piece or as separate parts coupled to each other, as mentioned above with respect to device 22. Additionally, struts 46 can provide an indication of the height of the valve annulus such that when device 42 is placed, the height of the annulus can be measured, for example, by imaging the struts when in contact with the annulus.

[0727] Device 42 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. Device 42 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or combinations thereof) into the femoral vein or jugular vein. For some applications, device 42 includes a wire.

[0728] Device 42 is configured to be placed along the native mitral valve. As shown, frame 44 of device 42 is substantially circular, and struts 46 are relatively spaced apart to fit within the commissures of the native mitral valve. For some applications, frame 44 of device 42 is substantially saddle-shaped. For some applications, device 42 includes an adjustment mechanism 48 that expands and contracts the perimeter of base frame 44. For some applications, base frame 44 is hollow and shaped to define a lumen, and adjustment mechanism 48 includes a wire that extends at least partially within the lumen of base frame 44. In such applications, the wire is pullable and / or twistable to adjust the perimeter of base frame 44. For some applications, a portion of base frame 44 telescopically collapses in response to pulling of the wire of adjustment mechanism 48.

[0729] Device 42 may be compressed toward the native heart valve during delivery. During delivery of device 42, device 42 is constrained in a collapsed state. A flexible pusher rod may be used to eject device 42 from the delivery catheter. In the absence of the catheter, device 42 will self-expand from its compressed state to its predetermined configuration, e.g., the configuration as Figure 1C shown.

[0730] Now refer to Figure 1A -C. Devices 22, 32, and 42 are made of a biocompatible metal or polymer material, or a metal or polymer material suitably coated, impregnated, or otherwise treated with a material imparting biocompatibility, or a combination of these materials, e.g., by machining, bending, forming, joining, molding, or extrusion. The material is also desirably radiopaque to facilitate fluoroscopic visualization.

[0731] Now refer to Figure 2A -F, Figure 2A -F is a schematic view of a method and system 60 for an annulus marking device for implanting Figure 1A -C.

[0732] In Figure 2A , device 22 is positioned along the annulus 66 of the native tricuspid valve 62, and device 32 is positioned along the annulus 68 of the native mitral valve 64. It should be noted that device 42 may be implanted along the mitral valve 64. As described above, devices 22 and 32 may be delivered to the atrium in a constrained configuration and then expanded within the atrium. For example, percutaneous vascular access may be achieved by conventional methods accessing the femoral vein or jugular vein.

[0733] In Figure 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). The frames 24 and 34 are adjusted by tool 70 to achieve the desired positioning of devices 22 and 32 along the annulus, respectively.

[0734] In Figure 2CIn this case, an implant (such as an annuloplasty structure 72) is positioned along the annulus 66 of the tricuspid valve 62 using a delivery tool 74, and the delivery tool 74 delivers the structure 72 into the right atrium via the superior vena cava or the inferior vena cava. The structure 72 may include a flexible body portion. For some applications, the body portion of the structure 72 is shaped to define a tubular sleeve through which a plurality of anchors are implanted. The body portion of the structure 72 includes a plurality of radiopaque markers 75 positioned at corresponding 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, so as to enable setting of the desired distance between tissue anchors along the body portion. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque materials or additional radiopaque materials, markers, etc. attached to or incorporated in the structure 72.

[0735] The structure 72 is delivered within the delivery tool 74. The delivery tool 74 is guided and manipulated according to imaging guided by the annulus marking device 22. That is, the structure 72 is positioned along the annulus 66 and anchored to the annulus 66 using the annulus marking device 22 under imaging to mark the tissue of the annulus and the commissures.

[0736] In some applications, at least a portion (such as at least three, some, all, etc.) of the longitudinal locations of the radiopaque markers 75 are longitudinally spaced apart at a constant interval. 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 to be equal to the desired distance between adjacent anchors. For example, the markers may include a first marker, a second marker, and a third marker, where the first marker and the second marker are adjacent, and the second marker and the third marker are adjacent, and the distance between the proximal and / or distal edges of the first marker and the second marker is equal to the corresponding distance between the proximal and / or distal edges of the second marker and the third marker. For example, the distance may be between 3 mm and 15 mm, such as 6 mm, and the longitudinal length of each marker may be between 0.1 mm and 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 will have a length of 4 mm.)

[0737] The annuloplasty structure 72 is used to repair the dilated valve annulus of the tricuspid valve 62. For some applications, the annuloplasty structure is configured to be placed only partially around the valve annulus (such as to present a C-shape), and once anchored in place, it contracts to circumferentially tighten the valve annulus.

[0738] For some applications, the structure 72 further includes an adjustment mechanism that facilitates the contraction and expansion of the annuloplasty structure 72 to facilitate adjustment of the annulus and the perimeter of the leaflets of the heart valve. For some applications, the adjustment mechanism includes a contraction member (such as a wire, cord, suture, elongate member, etc.) extending along the annuloplasty structure 72, and a rotatable structure (e.g., a spool, wheel, mandrel, etc.) configured to apply a contraction force to the contraction member to longitudinally contract the annuloplasty structure 72.

[0739] In Figure 2D it, an implant (such as the annuloplasty structure 76) is positioned along the annulus 66 of the mitral valve 64 using a delivery tool 74, and the delivery tool 74 passes the structure 76 into the left atrium via the superior vena cava or the inferior vena cava and then through the fossa ovalis. For some applications, the structure 76 includes a flexible body portion. For some applications, the body portion of the structure 76 is shaped to define a tubular sleeve through which a plurality of anchors are implanted. The body portion of the structure 76 includes a plurality of radio-opaque markers 75 positioned at corresponding 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, so as to be able to set the desired distance between tissue anchors along the body portion. For some applications, the markers comprise radio-opaque ink. For some applications, the markers include radio-opaque materials or additional radio-opaque materials, markers, etc. attached to or incorporated in the structure 76.

[0740] The structure 76 is delivered within the delivery tool 78. The delivery tool 78 is guided and manipulated according to imaging guided by the annulus marking device 32. That is, the structure 76 is positioned along the annulus 68 and anchored to the annulus 66 using the annulus marking device 32 under imaging to mark the tissue of the annulus and the commissures.

[0741] For some applications, at least a portion (e.g., at least three, such as all) of the longitudinal locations of the radio-opaque markers 75 are longitudinally spaced apart at a constant interval. 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 to be equal to the desired distance between adjacent anchors. For example, the markers may include a first marker, a second marker, and a third marker, where the first marker and the second marker are adjacent, and the second marker and the third marker are adjacent, and the distance between the proximal and / or distal edges of the first marker and the second marker is equal to the corresponding distance between the proximal and / or distal edges of the second marker and the third marker. For example, the distance may be between 3 mm and 15 mm, such as 6 mm, and the longitudinal length of each marker may be between 0.1 mm and 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 will have a length of 4 mm.)

[0742] An annuloplasty structure 76 is for repairing a dilated valve annulus of a mitral valve 64. For some applications, the annuloplasty structure is configured to be placed only partially around the valve annulus (e.g., to present a C-shape), and once anchored in place, contracts to circumferentially tighten the valve annulus. For some applications, the annuloplasty structure 76 is implemented using the techniques described in U.S. Application 12 / 437,103, filed May 7, 2009 and published as US2010 / 0286767 and / or U.S. Application 12 / 689,635, filed January 19, 2010 and published as US2010 / 0280604, both of which are assigned to the assignee of the present application and incorporated herein by reference.

[0743] For some applications, the structure 76 further includes an adjustment mechanism that facilitates the contraction and expansion of the annuloplasty structure 76 to adjust the perimeter of the annulus and leaflets of the heart valve. For some applications, the adjustment mechanism includes a contraction member (such as a wire, cord, suture, elongate member, etc.) extending along the annuloplasty structure 76, and a rotatable structure (e.g., a spool, wheel, mandrel, etc.) configured to apply a contraction force to the contraction member to longitudinally contract the annuloplasty structure 76.

[0744] Figure 2E Retrieval of the annulus marking device 22 after implantation of the annuloplasty structure 72 at the annulus 66 of the tricuspid valve 62 is shown. Since the device 22 is flexible and compressible, the device 22 is constrained by pulling the device 22 into the retrieval tool 80 during retrieval of the device 22 and subsequent removal of the device 22 from the subject's body. That is, for such embodiments, the device 22 does not serve as an implant and is only used to guide the implantation of the annuloplasty structure 72 (i.e., the implant); rather, the device 22 serves as a guide for implantation while being temporarily placed in the patient's body to be subsequently removed from the patient's body after implantation of the annuloplasty structure 72.

[0745] Figure 2F Retrieval of the annulus marking device 32 after implantation of the annuloplasty structure 76 at the annulus 68 of the mitral valve 64 is shown. Since the device 32 is flexible and compressible, the device 32 is constrained by pulling the device 32 into the retrieval tool 80 during retrieval of the device 32 and subsequent removal of the device 32 from the subject's body. That is, for such embodiments, the device 32 does not serve as an implant and is only used to guide the implantation of the annuloplasty structure 76 (i.e., the implant); rather, the device 32 serves as a guide for implantation while being temporarily placed in the patient's body to be subsequently removed from the patient's body after implantation of the annuloplasty structure 76.

[0746] Now refer to Figure 1A -C and Figure 2A -F. It should be noted that the annulus marking devices 22, 32, and 42 can be used as tracks for mechanically guiding the implantation of the annuloplasty structures described herein. When implanting the annuloplasty structure 76 along the annulus, the structure 76 can be pushed against the annulus when implanting the anchors into the annulus, such that the frames of the annulus marking devices 22, 32, and 42, which are less compliant than the annulus tissue, provide tactile feedback to the operator, and furthermore, can also be used as tracks at which the structure 76 deflects into the more compliant annulus tissue. That is, in addition to being a visual guide for moving the delivery tool along the annulus, the delivery tool for delivering the annuloplasty structure uses the frames of the devices 22, 32, and 42 as tactile and mechanical guides.

[0747] Now refer to Figure 3A -C, Figure 3A -C is a schematic view of the respective annulus marking devices 92 and 102, which are respectively similar to Figure 1A -B's devices 22 and 32, except that the devices 92 and 102 each include a plurality of radiopaque elements 99 (e.g., radiopaque markers, filaments, wires, extensions, beads, etc.), and the radiopaque elements 99 are, for example, but not limited to, the radiopaque filaments 99 described herein. The plurality of radiopaque filaments 99 serve as additional annulus marking devices. According to some applications, the annulus marking devices 92 and 102 are configured to assist in the implantation of cardiac devices under the guidance of imaging. The manipulation procedures are typically performed with the aid of imaging (such as fluoroscopy, transesophageal echo, and / or echocardiography).

[0748] Figure 3ASystem 90 is shown including an annulus marker device 92, the annulus marker device 92 including a radiopaque material formed to define a base frame 94 having a shape such that it tracks the circumference of the native heart valve annulus and approximates the shape of the annulus. The device 92 includes one or more struts 96 (e.g., three shown by way of illustration and not limitation). The struts 96 project away from the plane defined by the base frame 94 and are shaped to be placed in the commissures of the native valve. The struts 96 thus provide an indication of the location, height, and orientation of the commissures in imaging. The struts 96 are desirably sized and configured to contact tissue near or within the heart valve annulus to support the base frame 94 against migration within the annulus. The struts 96 are spaced apart to maintain engagement with tissue at or near the leaflet commissures (or anywhere tissue contact with the struts 96 is expected to occur). For some applications, the frame 94 and the struts 96 are manufactured as a single piece or as separate parts coupled to each other, as mentioned above with respect to device 22. Additionally, the struts 96 can provide an indication of the height of the valve annulus such that when the device 92 is placed, the height of the annulus can be measured, for example, by imaging the struts when in contact with the annulus.

[0749] The device 92 can be delivered percutaneously, thoracoscopically through the chest, and / or using open heart surgery techniques. The device 92 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods accessing the femoral or jugular vein under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 92 includes a wire.

[0750] The device 92 is configured to be placed 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 for expanding and contracting the perimeter of the base frame 94. For some applications, the base frame 94 is hollow and formed to define a lumen, and the adjustment mechanism 98 includes a wire that extends at least partially within the lumen of the base frame 94. In such applications, the wire is pullable and / or twistable to adjust the perimeter of the base frame 94. For some applications, a portion of the base frame 94 is telescopically collapsible in response to pulling of the wire of the adjustment mechanism 98.

[0751] The device 92 can be compressed toward the native heart valve during delivery. During delivery of the device 92, the device 92 is constrained in a collapsed state. A flexible pusher can be used to eject the device 92 from the delivery catheter. In the absence of the catheter, the device 92 will self-expand from its compressed state to its predetermined configuration, e.g., as Figure 3A The configuration shown.

[0752] Figure 3B System 100 is shown including an annulus marker device 102 that includes a radiopaque material formed to define a base frame 104 having a shape such that it tracks the circumference of the native heart valve annulus and approximates the shape of the annulus. Device 102 includes one or more struts 106 (e.g., three shown by way of illustration and not limitation). Struts 106 project away from the plane defined by base frame 104 and are shaped to be placed in the commissures of the native valve. Struts 106 thus provide an indication of the location, height, and orientation of the commissures in imaging. Struts 106 are desirably sized and configured to contact tissue near or within the heart valve annulus to support base frame 104 against migration within the annulus. Struts 106 are spaced apart to maintain engagement with tissue at or near the leaflet commissures (or anywhere tissue contact with struts 106 is expected to occur). For some applications, frame 104 and struts 106 are manufactured as a single piece or as separate parts coupled to one another as mentioned above with respect to device 22. Additionally, struts 106 can provide an indication of the height of the valve annulus such that when device 102 is placed, the height of the annulus can be measured, for example, by imaging the struts when in contact with the annulus.

[0753] Device 102 can be delivered percutaneously, thoracoscopically through the chest, and / or using open heart surgery techniques. Device 102 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods accessing the femoral or jugular vein under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or combinations thereof). For some applications, device 102 includes wires.

[0754] The device 102 is configured to be placed along the native mitral valve. Accordingly, the frame 104 of the device 102 is substantially D-shaped, and the struts 106 are relatively spaced apart to fit within the commissures of the native mitral valve. For some applications, the frame 104 of the device 102 is substantially saddle-shaped. For some applications, the device 102 includes an adjustment mechanism 108 that expands and contracts the perimeter of the base frame 104. For some applications, the base frame 104 is hollow and shaped to define a lumen, and the adjustment mechanism 108 includes a wire that extends at least partially within the lumen of the base frame 104. In such applications, the wire is pullable and / or twistable to adjust the perimeter of the base frame 104. For some applications, a portion of the base frame 104 is telescopically collapsible in response to pulling of the wire of the adjustment mechanism 108.

[0755] The device 102 may be compressed toward the native heart valve during delivery. During delivery of the device 102, the device 102 is constrained in a collapsed state. A flexible pusher rod may be used to eject the device 102 from the delivery catheter. In the absence of the catheter, the device 102 will self-expand from its compressed state to its predetermined configuration, e.g., the configuration as Fig. 10B shown.

[0756] The frame 104 of the device 102 may be circular or other shapes.

[0757] Now referring to Figure 3A -C, a plurality of radiopaque filaments 99 comprise a radiopaque material (e.g., nitinol or stainless steel) and may be configured to be extremely flexible. The filaments 99 project radially away from the base frames 94 and 104.

[0758] For some applications, the filaments 99 sway with the movement of the blood. For some applications, the filaments 99 press against the tissue of the annulus and the tissue coupled thereto (as Figure 3C shown), such as the tissue of the atrial wall 122 and the tissue of the leaflets of the native valve. Throughout this disclosure, the term "press against" has the same or similar meaning as the terms "push against", "place against", or "align against", regardless of the strength of the force applied. Thus, the filaments 99 provide enhanced imaging of the tissue of the valve 64. That is, when the filaments 99 appear bent or compressed, the imaging detects the annulus tissue, and when the filaments 99 are straight, this may indicate the orifice of the valve. Figure 3C A system 120 is shown where the device 102 is positioned within the native mitral valve 64. The frame 104 is positioned along the annulus 68, while the struts 106 are each placed at the commissures 65 and 67. As mentioned above, the struts 106 provide an indication of the height of the valve annulus 64. During positioning of the device 102, the native valve 64 functions normally.

[0759] Now referring to Figure 4A -B, Figure 4A -B is a schematic view of a system 140 including an implant for some applications. The implant includes an annuloplasty structure 142. The annuloplasty structure 142 includes a body portion 144 and an annulus marking device. The annulus marking device includes a plurality of radiopaque protrusions. The plurality of radiopaque protrusions are distributed along and attached to the body portion 144 and are shaped to define a plurality of tubular elements 148. 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 that is shaped to define a lumen therethrough, 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 of the tubular elements 148 project away from the longitudinal axis 141.

[0760] The body portion 144 may include a braided fabric mesh, such as including DACRON(TM). The body portion 144 may be configured to be placed only partially around a heart valve annulus (e.g., to present a C-shape), and once anchored in place, contract to circumferentially tighten the valve annulus. Optionally, the structure 142 may be configured to be placed completely around the valve annulus (e.g., in a closed circular or other closed shape). To tighten the annulus, the annuloplasty structure 142 includes a flexible elongate contraction member 145 extending along the body portion 144. The elongate contraction member 145 includes a wire, strip, cord, or band, which generally includes a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt-chromium alloy. For some applications, the contraction member 145 includes a radiopaque material. For some applications, the contraction member 145 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 145 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 145 includes a plurality of wires wound to form a cord structure.

[0761] The plurality of radiopaque protrusions include the tubular elements 148. The tubular elements 148 include a flexible fabric. In some applications, the tubular elements 148 and the body portion 144 include the same material. The tubular elements 148 may taper away from the axis 141, as shown. As shown, the distal end of each element 148 (i.e., the end of the element 148 furthest from the body portion 144) is closed such that the element 148 is shaped as a pouch. For some applications, each of the elements 148 is shaped to define a windsock.

[0762] The body portion 144 of the structure 142 includes a plurality of radiopaque markers 146 positioned at respective longitudinal locations along the structure 142. 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 enable setting of the desired distance between tissue anchors 147 along the body portion 144 and thus indication of the placement of the anchors 147. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque material attached to or incorporated within the body portion 144.

[0763] As shown, a contraction member 145 is coupled to the body portion 144 and extends along the body portion 144 and through a plurality of tubular elements 148 in a manner 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 projections including the tubular elements 148. As Figure 4B shown, the contraction member 145 is configured to change the structural configuration of the elements 148 by closing openings 149 in each of the tubular elements 148 (the openings 149 are shown in Figure 4A ). In such an embodiment, as shown, the contraction member 145 extends along the perimeter of each opening 149 of each tubular element 148. For some applications, the contraction member 145 travels along the perimeter 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 contraction member is configured to sequentially change the spatial configuration of the tubular elements 148.

[0764] For some applications, the contraction member 145 is configured to additionally apply a contraction force to the body portion 144 of the structure 142 to facilitate adjustment of the perimeter of the annuloplasty structure 142. For example, adjustment of the annuloplasty structure 142 can be performed by an adjustment mechanism similar to the adjustment mechanism described above with respect to the annuloplasty structure 72. For some applications, the system 140 includes an additional contraction member (not shown) configured to adjust the perimeter of the body portion 144 when the contraction member 145 adjusts the spatial configuration of the plurality of radiopaque projections including the tubular elements 148.

[0765] For some applications, multiple radial protrusions including the tubular element 148 are all completely radiopaque. For some applications, at least 50% of each protrusion is radiopaque. The multiple radial protrusions including the tubular element 148 help to facilitate visualization of the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus under imaging. For some applications, the multiple radial protrusions including the tubular element 148 are placed against and adjacent to the tissue of the annulus and / or the tissue coupled thereto (e.g., atrial wall tissue and / or tissue of the leaflets of the native valve). For some applications, at least some of the multiple radial protrusions including the tubular element 148 are positioned in the path of the blood flow. The multiple radial protrusions can provide information related to the tissue and / or the blood flow in response to movement of the tubular element 148.

[0766] Now refer to Figure 5A -B, Figure 5A -B is a schematic view of a system 160 including an implant according to some applications. The implant includes an annuloplasty structure 162. The annuloplasty structure 162 includes a body portion 164 and an annulus marking device. The annulus marking device includes multiple radiopaque protrusions that are distributed along and attached to the body portion 164 and are shaped to define multiple flat and planar elements 168. 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 that is shaped to define a lumen therethrough, 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 and planar elements 168 protrude away from the longitudinal axis 161.

[0767] The body portion 164 may include a braided fabric mesh, such as including DACRON(TM). The body portion 164 may be configured to be placed only partially around the heart valve annulus (e.g., to present a C-shape), and once anchored in place, contract to circumferentially tighten the valve annulus. Optionally, the structure 162 may be configured to be placed completely around the valve annulus (e.g., in a closed circular or other closed shape). To tighten the annulus, the annuloplasty structure 162 includes a flexible elongate contraction member 165 that extends along the body portion 164. The elongate contraction member 165 includes a wire, strip, cord, or band, which may include a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt-chromium alloy. For some applications, the contraction member 165 includes a radiopaque material. For some applications, the contraction member 165 includes a braided polyester suture (e.g., Ticron). For some applications, the contraction member 165 is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member 165 includes multiple wires wound to form a cord structure.

[0768] The plurality of radiopaque projections includes a flat and planar element 168, and the flat and planar element 168 includes a flexible fabric. For some applications, the flat and planar element 168 and the body portion 164 comprise the same material. Each of the flat and planar elements 168 has a longest dimension measured along an axis that is at a non-zero angle (i.e., not parallel) with respect to the longitudinal axis 161 of the body portion 164.

[0769] The body portion 164 of the structure 162 includes a plurality of radiopaque markers 166 positioned at respective longitudinal locations along the structure 162. 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, in order to be able to set the desired distance between tissue anchors 167 along the body portion 164, and thus indicate the placement of the anchors 167. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque materials or additional radiopaque materials, markers, etc. attached to or incorporated in the body portion 164.

[0770] As shown, the shrinkage member 165 is coupled to the body portion 164 and extends along the body portion 164 and passes through the plurality of flat and planar elements 168 in such a way that during application of tension to the shrinkage member 165, the shrinkage member 165 is configured to change the structural configuration of the plurality of radiopaque projections including the flat and planar elements 168. As Figure 5B shown, the shrinkage member 165 is configured to change the structural configuration of the element 168 by compressing and / or folding the element 168. In such an embodiment, as shown, the shrinkage member 165 travels along the perimeter of each flat and planar element 168 such that during application of tension to the shrinkage member 165, the member 165 is configured to radially compress each flat and planar element 168 towards the axis 161 of the structure 162. For some applications, the shrinkage member is configured to sequentially change the spatial configuration of the flat and planar elements 168.

[0771] For some applications, the shrinkage member 165 is configured to additionally apply a shrinking force to the body portion 164 of the structure 162 in order to facilitate adjustment of the perimeter of the annuloplasty structure 162. For example, the adjustment of the annuloplasty structure 162 can be performed by an adjustment mechanism (shrinkage member and spool, wheel, mandrel, etc.) similar to the adjustment mechanism described above with respect to the annuloplasty structure 72. For some applications, the system 160 includes an additional shrinkage member (not shown) configured to adjust the perimeter of the body portion 164 when the shrinkage member 165 adjusts the spatial configuration of the plurality of radiopaque projections including the flat and planar elements 168.

[0772] For some applications, multiple radial protrusions of the flat and planar element 168 are all completely radiopaque. For some applications, at least 50% of each protrusion is radiopaque. The multiple radial protrusions including the flat and planar element 168 help to facilitate the visualization of the tissue of the native heart valve annulus and the tissue coupled to the native heart valve annulus under imaging. For some applications, the multiple radial protrusions including the flat and planar element 168 are placed against and adjacent to the tissue of the annulus and / or the tissue coupled thereto (e.g., atrial wall tissue and / or tissue of the leaflets of the native valve). For some applications, at least some of the multiple radial protrusions including the flat and planar element 168 are positioned in the path of the blood flow. The multiple radial protrusions can provide information related to the tissue and / or the blood flow in response to the movement of the flat and planar element 168.

[0773] In some applications, the anchor 167 includes a biocompatible material such as stainless steel 316LVM. For some applications, the anchor 167 includes nitinol. For some applications, the anchor 167 is completely or partially coated with a non-conductive material.

[0774] Now referring Fig. 6A , Fig. 6A is a schematic view of a system 170 including a tissue anchor 176, the tissue anchor 176 including a distal tissue coupling element 173 and an annulus marking device, the distal tissue coupling element 173 having a longitudinal axis 175 measured from the distal end to the proximal end of the distal tissue coupling element 173, the annulus marking device having a plurality of radiopaque elements (e.g., filaments 99) coupled to the tissue anchor 176. According to some applications, the filaments 99 or other radiopaque elements include a radiopaque material and project away from the axis 173. The distal tissue coupling element 173 is configured to be anchored into the tissue of the native heart valve annulus 68.

[0775] In some embodiments, the plurality of radiopaque filaments 99 include a radiopaque material (e.g., nitinol or stainless steel) and are configured to be extremely flexible. The filaments 99 project away from the anchor 176. According to some applications, the filaments 99 are configured to assist in the implantation of a cardiac device (e.g., an annuloplasty structure 172) under the guidance of imaging. The implantation of the anchor 176 and the annuloplasty structure 172 is typically performed with the aid of imaging (such as fluoroscopy, transesophageal echo, and / or echocardiography).

[0776] For some applications, the filaments 99 sway with the movement of the blood. For some applications, prior to placing a portion of the structure 172 along the annulus 68 and prior to piercing the tissue of the annulus 68 with the distal tip of the anchor 176, the filaments 99 are pressed against the tissue of the annulus and the tissue coupled thereto (e.g., tissue such as the atrial wall 122 and the tissue of the leaflets of the native valve), as Fig. 6Aas shown in View A. That is, the distal tip of the anchor 176 pierces through a portion of the body portion 174 of the structure 172 and passes the filament 99 through the fabric of the body portion 174 such that the filament 99 can bear against the tissue of the annulus and the tissue coupled thereto. Thus, the filament 99 thereby provides enhanced imaging of the tissue of the heart valve 64.

[0777] It should be noted that although the system 170 is shown on the mitral valve 64, the system 170 can be used on any heart valve (e.g., tricuspid valve) of a subject or any other tissue.

[0778] In some applications, the anchor 176 includes a biocompatible material such as stainless steel 316LVM. For some applications, the anchor 176 includes nitinol. For some applications, the anchor 176 is fully or partially coated with a non-conductive material.

[0779] For some applications, each distal tissue-coupling element 173 of the anchor 176 is hollow, and during delivery of the anchor 176 to the atrium of the heart, the filament 99 can be compressed within the lumen of the hollow element 173 and, once inside the atrium, the filament 99 expands from within the lumen.

[0780] The annuloplasty structure 172 can include a braided fabric mesh, such as including DACRON(TM). The annuloplasty structure 172 can be configured to be placed only partially around the heart valve annulus (e.g., to present a C-shape) and, once anchored in place, contract to circumferentially tighten the valve annulus. Optionally, the structure 172 can be configured to be placed completely around the valve annulus (e.g., in a closed circular or other closed shape).

[0781] As shown, for some applications, the annulus marking device including the filament 99 is coupled to the distal end of the distal tissue-coupling element 173. The structure 172 includes fabric, and the annulus marking device including the filament 99 is configured to pass through the fabric of the structure 172. It should be noted that additional filaments 99 can be coupled to the distal tissue-coupling element 173 or any other part of the anchor 176.

[0782] It should be noted that for some applications, the filament 99 can be coupled to an anchor driver for driving the anchor into tissue.

[0783] Now refer to Figure 6B , Figure 6BFIG. 0 is a schematic illustration of a system 180 that includes a tissue anchor 176, the tissue anchor 176 including a distal tissue coupling element 173 and an annulus marking device, the distal tissue coupling element 173 having a longitudinal axis 175 measured from the distal end to the proximal end of the distal tissue coupling element 173, the 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. The distal tissue coupling element 173 is configured to be anchored into the tissue of the native heart valve annulus 68.

[0784] The plurality of radiopaque filaments 99 include a radiopaque material (e.g., nitinol or stainless steel) and may be configured to be extremely 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 (e.g., an annuloplasty structure 182) under the guidance of imaging. The implantation of the anchor 176 and the annuloplasty structure 172 is typically performed with the aid of imaging (such as fluoroscopy, transesophageal echo, and / or echocardiography).

[0785] For some applications, the filaments 99 sway with the movement of the blood. Thus, the filaments 99 provide enhanced imaging of the tissue of the heart valve 64.

[0786] By way of illustration and not limitation, the annuloplasty structure 182 includes a flat band. The structure 182 includes a woven fabric or a woven metal and is not tubular in shape.

[0787] It should be noted that although the system 180 is shown on the mitral valve 64, the system 180 can be used on any heart valve (e.g., the tricuspid valve) or any other tissue of the subject.

[0788] For some applications, the anchor 176 includes a biocompatible material, such as stainless steel 316LVM. For some applications, the anchor 176 includes nitinol. For some applications, the anchor 176 is completely or partially coated with a non-conductive material.

[0789] The annuloplasty structure 182 may include a woven fabric mesh, such as including DACRON(TM). The annuloplasty structure 182 may be configured to be placed only partially around the heart valve annulus (e.g., to present a C-shape) and, once anchored in place, contract to circumferentially tighten the valve annulus. Optionally, the structure 182 may be configured to be placed completely around the valve annulus (e.g., in a closed circular or other closed shape).

[0790] As shown, structure 182 is flat, and after implanting the anchor 176, the head 177 is disposed above the flat band. Once implanted into tissue, the filament 99 provides an indication of its placement above the band of the structure 182.

[0791] Now refer to Fig. 7A -C, Fig. 7A -C is a schematic view of a system 190 including an implant according to some applications. The implant includes an annuloplasty structure 192, and the annuloplasty structure 192 includes a body portion 194 and annulus marking means. The annulus marking means includes one or more (e.g., two, as shown) planar radiopaque fins 196. The body portion 194 includes a flexible material, such as a woven fabric mesh. For some applications, the body portion 194 is shaped to define a sleeve that is shaped to define a lumen therethrough, as shown. For some applications, the body portion 194 is flat. The body portion 194 extends along the central longitudinal axis 191 of the structure 192, and the radiopaque fins 196 project away from the longitudinal axis 191. Each of the radiopaque fins 196 has a longest dimension measured along the longitudinal axis 191.

[0792] The body portion 194 may include a woven fabric mesh, such as including DACRON(TM). The body portion 194 may be configured to be placed only partially around the heart valve annulus (e.g., to present a C-shape), and once anchored in place, contract to circumferentially tighten the valve annulus. Optionally, the structure 192 may be configured to be placed completely around the valve annulus (e.g., in a closed circular or other closed shape). To tighten the annulus, the annuloplasty structure 192 includes a flexible elongate contraction member (not shown) extending along the body portion 194. The contraction member includes a wire, strip, cord, or band, which generally includes a flexible and / or superelastic material, such as nitinol, polyester, stainless steel, or cobalt-chromium alloy. For some applications, the contraction member includes a radiopaque material. For some applications, the contraction member includes a woven polyester suture (e.g., Ticron). For some applications, the contraction member is coated with polytetrafluoroethylene (PTFE). For some applications, the contraction member includes a plurality of wires wound to form a cord structure.

[0793] The planar radiopaque fins 196 include a flexible fabric. In some applications, the fins 196 and the body portion 194 include the same material.

[0794] The body portion 194 of the structure 192 includes a plurality of radiopaque markers 195 positioned at corresponding longitudinal locations along the 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 the implantation procedure, so as to enable setting of a desired distance between tissue anchors 198 along the body portion 194. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque materials or additional radiopaque materials, markers, etc. attached to or incorporated in the body portion 164.

[0795] Figure 7B A cross-section of the structure 172 is shown, which shows the body portion 194 and the fins 196.

[0796] In some applications, the fins 196 are all completely radiopaque. For some applications, at least 50% of each fin 196 is radiopaque. The fins 196 help facilitate viewing of the tissue of the native heart valve annulus and the tissue coupled thereto under imaging. For some applications, as Figure 7C shown, the fins 196 are placed against and adjacent to the tissue of the annulus and / or the tissue coupled thereto (e.g., the tissue of the atrial wall 122 and / or the tissue of the leaflets of the native valve). For some applications, the fins 196 are positioned in the path of the blood flow and provide information related to the tissue and / or the blood flow in response to movement of the fins 196.

[0797] As Figure 7C shown, the anchors 198 for anchoring the structure 192 to the tissue of the annulus 68 are designated for implantation between the fins 196.

[0798] For some applications, the fins 196 include shape memory wires that help them expand to assume their shape. For some applications, the fabric of the fins 196 is thinner than the fabric of the body portion 194.

[0799] It should be noted that although the system 190 is shown on the mitral valve 64, the system 190 can be used on any heart valve (such as the tricuspid valve) or any other tissue of the subject.

[0800] Now refer to Fig. 8A -B, Fig. 8A-FIG. B is a schematic illustration of a system 200 for some applications, the system 200 including an annulus marking device 202 for assisting in the implantation of a cardiac device under imaging guidance. The device 202 includes a frustoconical scaffold 203 having a plurality of struts 204 arranged in a frustoconical shape. The scaffold 203 is collapsible and deployable. The annulus marking device 202 is configured to travel in parallel with at least one side of a body portion 210 of an implant 209 (e.g., an annuloplasty structure, as shown), the implant 209 being configured to be placed along a native cardiac valve annulus 68 of a mitral valve 64 of a subject. As shown, the device 202 surrounds a given portion of the body portion 210 because it is frustoconical in shape. The body portion 210 of the implant 209 includes a flexible material and has a longitudinal axis (e.g., when the body portion is straightened) that travels along the length of the body portion 210. The body portion 210 includes radiopaque markers 211 to assist in imaging for accurately delivering an anchor to the annulus 68 in order to anchor the implant 209 to the tissue of the annulus 68.

[0801] The scaffold 203 includes a radiopaque material (e.g., nitinol or stainless steel) and is flexible. The scaffold 203 is coupled proximally to a proximal ring 206 at the proximal end of the scaffold 203. For some applications, the scaffold 203 includes the ring 206. The ring 206 surrounds at least a portion of the body portion 210 of the implant 209 and is movable proximally and distally relative to the body portion 210 in such a way that the scaffold 203 can move to a plurality of positions along the body portion 210 of the implant 209.

[0802] The annulus marking device 202 is coupled to a delivery tool 208 that is configured to deliver the implant 209 to the annulus 68. The annulus marking device 202 can be retrieved after the delivery tool 208 is removed 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., completely surround a portion of the body portion 210.

[0803] For some applications, multiple radiopaque elements (such as radiopaque filaments 99 (or other radiopaque markers, wires, extensions, beads, etc.)) are coupled to the stent 203 at their distal portions. The multiple radiopaque elements or filaments 99 serve as additional annulus marking devices. According to some applications, the annulus marking device 202 is configured to assist in the implantation of a cardiac device under the guidance of imaging. Manipulation procedures are performed with the aid of imaging (such as fluoroscopy, transesophageal echo, and / or echocardiography).

[0804] The device 202 can be delivered percutaneously, thoracoscopically through the chest, or using open-heart surgical techniques. If delivered percutaneously, the device 202 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof) into the femoral vein or the jugular vein. For some applications, the device 202 includes a wire.

[0805] The multiple radiopaque filaments 99 include a radiopaque material (e.g., nitinol or stainless steel) and can be configured to be extremely flexible. For some applications, the filaments 99 sway with the movement of the blood. For some applications, the filaments 99 press against the tissue of the annulus and the tissue coupled thereto (as shown in FIG. 8), such as the tissue of the atrial wall 122 and the tissue of the leaflets 123 of the native valve. Thus, the filaments 99 provide enhanced imaging of the tissue of the valve 64.

[0806] For some applications, the delivery tool 208 includes fins (not shown, but shown as fins 227 in Fig. 10B ), which are coupled to the distal portion of the delivery tool 208 and a portion of the stent 203 in such a way that the fins rotate the stent 203 relative to the body portion 210 of the implant 209 in response to the movement of the blood flow. In this way, the operator can distinguish the tissue of the atrial wall and the leaflet tissue with the aid of imaging.

[0807] Now refer to Figure 8B。For some applications, the plurality of radiopaque elements or 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 rotationally orient the gantry 203 relative to the implant 209. That is, the second subset of filaments 99 having the longer length will orient the gantry 203 in such a way that the second subset of the longer filaments 99 will be aligned against the tissue of the leaflets 123 and the first subset of the shorter filaments 99 will be aligned against 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 length. The first and second subsets are configured to rotationally orient the gantry 203 relative to the implant 209. That is, the second subset of filaments 99 having the greater stiffness will orient the gantry 203 in such a way that the second subset of the more rigid filaments 99 will be aligned against the tissue of the leaflets 123 and the first subset of the less rigid filaments 99 will be aligned against the tissue of the atrial wall 122.

[0808] After implantation of the implant 209, the annulus marking device 202 is retrieved. Since the device 202 is flexible and compressible, the device 202 is constrained within the tool during retrieval of the device 202 and subsequent removal of the device 202 from the body of the subject. That is, for such embodiments, the device 202 does not function as an implant and is only used to guide the implantation of the implant 209; rather, the device 202 functions as a guide for implantation while being temporarily placed within the patient's body to be subsequently removed from the patient's body after implantation of the implant 209.

[0809] It should be noted that although the system 200 is shown on the mitral valve 64, the system 200 can be used on any heart valve (e.g., tricuspid valve) or any other tissue of a subject.

[0810] Reference Fig.9A -B, Fig.9A-B is a schematic view of a navigation-based guidance system 230 for some applications. The navigation-based guidance system 230 employs one or more longitudinal guides 232 that are configured to facilitate guiding an implant 231 to a particular portion of an annulus 68 via a guide that contacts a surface of a valve (e.g., the annulus, commissures, and / or leaflets of the valve). The guides 232 include a flexible material (e.g., a flexible metal such as nitinol or stainless steel), and each guide 232 is radiopaque. A plurality of apertures 234 are disposed along a lateral outer surface of a body portion 233 of the implant 231, and each guide 232 (e.g., its distal portion) is disposed within at least some of the apertures (e.g., the guide passes through the aperture). The apertures 234 may include suture or fabric.

[0811] In some applications, the apertures 234 are arranged in longitudinal rows along the length of the body portion 233, and each guide 232 is disposed within the apertures of a corresponding row. In some applications, the apertures of each row are disposed at the same longitudinal location as the corresponding apertures of each other row. For some applications, the body portion 233 includes a plurality of radiopaque markers 235 that are positioned at corresponding longitudinal locations along the body portion. For some applications, the apertures of each row are disposed at the same longitudinal location as the corresponding radiopaque marker. However, optionally, the apertures may be disposed between the radiopaque markers. The guides 232 are disposed at corresponding circumferential positions around the body portion 233 (e.g., its longitudinal axis). In Fig.9A -B, each of the three guides is shown as being disposed around the body portion 233 from an adjacent guide at approximately 120 degrees, but the scope includes other arrangements, such as two guides disposed opposite each other.

[0812] For some applications, each guide 232 includes a wire having a looped portion 238 such that the guide has (1) two parallel linear portions of the wire, and (2) a looped portion at the distal portion 236 of the guide.

[0813] For some applications, the distal portion 236 of each guide 232 is biased (e.g., shaped) to project radially outward from the body portion 233. This bias can impart a desired behavior to the guide, for example, during distal movement of the guide. For example, when the guide moves distally against tissue, the bias can facilitate the guide opening on the tissue (e.g., as described below). Alternatively or additionally, after the guide has been retracted proximally from a given aperture, the bias can inhibit (e.g., prevent) the guide from re-penetrating the given aperture when the guide subsequently moves distally again.

[0814] The body portion 233 is configured to be advanced distally away from the delivery tool 208 and anchored to the annulus 68 using an anchor.

[0815] The guide 232 is placed against the tissue of the valve (e.g., pushed) by, for example, being disposed distally of the distal end of the body portion 233 or by being advanced distally after the distal end of the body portion has been placed against the tissue of the valve itself. Accordingly, each guide 232 (e.g., its loop portion 238) includes a tissue engaging portion configured to be placed in contact with the tissue of the subject.

[0816] In one or more ways, the guide 232 facilitates guidance by observing the body portion 233 (e.g., the positioning of the body portion on the annulus) in response to being placed against the valve tissue. For example:

[0817] The resistance to further distal pushing of the guide can indicate contact of the guide with tissue resisting the force exerted by the guide. For example, the distal end of the guide can abut the annulus 68 and / or the wall 122 of the atrium (as Fig. 9B shown). Conversely, the absence of resistance to further distal pushing of the guide can indicate that the distal end of the guide is not in contact with tissue resisting the force exerted by the guide. For example, the distal end of the guide can move between the leaflets 123 of the valve (e.g., at the commissure), and / or can push down on the leaflets 123 (e.g., into the ventricle). This resistance (or lack thereof) can be detected mechanically (e.g., as haptic feedback to the operator and / or via an extracorporeal control unit). Since the guide 232 includes a radiopaque material, this resistance (or lack thereof) can be detected via imaging (e.g., fluoroscopically).

[0818] Similarly, the position, orientation, and / or shape of a 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 the guide is positioned against, if anything. 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 as the distal end of the body portion 233 (i.e., at the same position on the vertical axis of the subject), this can indicate that the body portion 233 and the guide 232 are adjacent to the same surface (e.g., the 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 disposed against the annulus 68 while the guide 232 has been delivered or advanced toward the ventricle. Movement (e.g., bouncing) of the guide can indicate that the guide is disposed against a leaflet of the valve and that the leaflet is moving the guide during a heartbeat. Such imaging can be facilitated by one or more components that include radiopaque markers. For some applications, each guide 232 has a different radiopaque marker to facilitate identification during imaging.

[0819] One or more of the guides 232 can inhibit movement of the body portion 233 of the implant 231. For example, if the guide extends between leaflets at a commissure, the guide can inhibit movement of the body portion 233 away from the commissure.

[0820] The guides 232 can be configured and / or selected collectively or individually such that the guides act in a particular manner when interacting with tissue. For example, the guides can be configured and / or selected to be (1) rigid enough to provide tactile feedback when adjacent to tissue, and / or (2) flexible enough to open over tissue without damaging the tissue and / or to be movable by bouncing a leaflet.

[0821] Fig. 9B It is shown that the body portion 233 has been placed against the annulus 68 of the subject near the left fibrous trigone. The guide 232 has been pushed distally and has opened through the annulus 68, for example due to the resistance of the annulus (see Fig. 9B View A). As described above, this can be detected mechanically and / or by imaging. The guide 232a, which has also been pushed distally, extends between leaflets 123 at a commissure (see Fig. 9BView B). As described above, this can be detected mechanically and / or using imaging. The orientation, alignment, and / or shape of each guide, alone and / or in combination with other guides and / or elements, indicates the positioning of the portion of the body portion 233 against firm tissue near the commissure, which is a preferred orientation for anchoring the portion of the body portion 233 for some applications. Identification of which guide is in which orientation (e.g., mechanically and / or via imaging) can further indicate the rotational orientation of the body portion 233.

[0822] Once the desired orientation has been identified, an anchor (e.g., a first anchor) is used to anchor the body portion 233. For some applications, one or more of the guides 232 may be retracted slightly proximally prior to anchoring, e.g., to reduce the likelihood of inadvertently anchoring the guide to the tissue. Subsequently, additional portions of the body portion 233 are anchored to the annulus 68. In some applications, the guide 232 is moved proximally relative to the body portion 233. This process may be repeated for each anchor until the implant 231 is fully implanted.

[0823] It should be noted that although the system 230 is shown on the mitral valve 64, the system 230 may be used on any heart valve (e.g., tricuspid valve) or any other tissue of the subject.

[0824] Now refer to Fig. 10A -B, Fig. 10A -B is a schematic illustration of a system 220 according to some applications, the system 220 including an annulus marking device 222 for assisting in the implantation of a cardiac device under the guidance of imaging. The device 222 includes a generally triangular scaffold 223 having a plurality of struts 204 arranged in a generally triangular shape. The scaffold 223 is collapsible and expandable. The annulus marking device 222 is configured to travel in parallel with at least one side of a body portion 210 of an implant 209 (e.g., an annuloplasty structure, as shown), the implant 209 being configured to be placed along the native cardiac valve annulus 68 of the mitral valve 64 of the subject. As shown, the device 222 is positioned in front of and prior to the body portion 210. The device 222 guides the implant 209. The body portion 210 of the implant 209 includes a flexible material and has a longitudinal axis (e.g., when the body portion is straightened) that travels along the length of the body portion 210. The body portion 210 includes radiopaque markers to assist in imaging for accurately delivering an anchor to the annulus 68 in order to anchor the implant 209 to the tissue of the annulus 68.

[0825] The scaffold 223 comprises a radiopaque material (e.g., nitinol or stainless steel) and is flexible. The scaffold 223 is coupled to the proximal ring 226 at the proximal end of the scaffold 223. For some applications, the scaffold 223 comprises the ring 226. The ring 226 surrounds at least a portion of the body portion 210 of the implant 209 and is movable proximally and distally relative to the body portion 210 in a manner such that the scaffold 223 can move to multiple positions along the body portion 210 of the implant 209. For some applications, the scaffold 223 is semi-tubular.

[0826] The annulus marker device 222 is coupled to a delivery tool 208 configured to deliver the implant 209 to the annulus 68. The annulus marker device 222 can be retrieved after 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 marker device 222 is configured to at least partially surround the body portion 210 of the implant 209, e.g., one side of the body portion 210, as shown.

[0827] For some applications, the scaffold 223 is planar and triangular, as shown. For some applications, the scaffold 223 is semi-tubular.

[0828] 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 serve as additional annulus marker devices. According to some applications, the annulus marker device 222 is configured to assist in the implantation of a cardiac device under the guidance of imaging. The manipulation procedure is performed with the aid of imaging (such as fluoroscopy, transesophageal echo, 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 annulus 68, a third subset of the filaments 99 contacts the leaflets 123, and a fourth subset of the filaments 99 extends between above the orifice of the valve and the leaflets 123.

[0829] The device 222 can be delivered percutaneously, thoracoscopically through the chest, or using open-heart surgery techniques. If delivered percutaneously, the device 222 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods accessing the femoral vein or jugular vein under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof). For some applications, the device 222 includes wires.

[0830] The plurality of radiopaque filaments 99 include a radiopaque material (e.g., nitinol or stainless steel) and can be configured to be extremely flexible. For some applications, the filaments 99 sway with the movement of the blood. For some applications, the filaments 99 press against the tissue of the annulus and the tissue coupled thereto (as shown in FIG. 10), such as the tissue of the atrial wall 122. Thus, the filaments 99 provide enhanced imaging of the tissue of the valve 64.

[0831] Now refer to Fig. 10B . For some applications, the delivery tool 208 includes fins 227 that are coupled to the distal portion of the delivery tool 208 and a portion of the cradle 223 in such a way that the fins 227 rotationally orient the cradle 223 relative to the body portion 210 of the implant 209 in response to the movement of the blood flow. In this way, the operator can distinguish the tissue of the atrial wall and the leaflet tissue with the aid of imaging. For some applications, the fins 227 are radiopaque. For some applications, the distal portion of the fins 227 extends into the ventricle.

[0832] Now refer to Figure 8B and Fig. 10A-B. 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, the second length being greater than the first length. The first and second subsets are configured to rotationally orient the gantry 223 relative to the implant 209. That is, the second subset of filaments 99 having the longer length will orient the gantry 223 in such a way that the second subset of the longer filaments 99 will align against the tissue of the leaflet 123 while the first subset of the shorter filaments 99 will align against 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, the second stiffness being greater than the first length. The first and second subsets are configured to rotationally orient the gantry 223 relative to the implant 209. That is, the second subset of filaments 99 having the greater rigidity will orient the gantry 223 in such a way that the second subset of the more rigid filaments 99 will align against the tissue of the leaflet 123 while the first subset of the less rigid filaments 99 will align against the tissue of the atrial wall 122.

[0833] For some applications, a first subset of the filaments 99 contacts the atrial wall 122, a second subset of the filaments 99 contacts the annulus 68, a third subset of the filaments 99 contacts the leaflet 123, and a fourth subset of the filaments 99 extends between above the orifice of the valve and the leaflet 123.

[0834] Referring again to Fig. 10A -B. In some applications, the device 222 is configured to be placed between the implant 209 and the tissue of the atrial wall 122, as shown.

[0835] After implantation of the implant 209, the annulus marking device 222 is retrieved. Since 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 is not used as an implant and is only used to guide the implantation of the implant 209; rather, the device 222 serves as a guide for implantation while being temporarily placed within the patient's body to be subsequently removed from the patient's body after implantation of the implant 209.

[0836] It should be noted that although the system 220 is shown on the mitral valve 64, the system 220 can be used on any heart valve of a subject (e.g., tricuspid valve) or any other tissue.

[0837] Now referring to Fig.11A -C, Fig.11A-FIG. C is a schematic illustration of a system 250 including an annulus marking device 252 for some applications. The annulus marking device 252 includes a tubular stent body 254 having a central longitudinal axis 251 and a plurality of extensions 256 coupled to the 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 for placement within a native heart valve of an object, such as the mitral valve 64 (shown), the tricuspid valve, or any other heart valve.

[0838] The plurality of extensions 256 are configured for placement along the circumference of the annulus 68 of the valve 64. In some applications, prior to implantation of the implant along the annulus 68, the annulus marking device is positioned within the valve 64 and is thus configured to provide guidance for implantation of 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 toward the valve 64 and is expandable from a compressed state to be positioned within the native heart valve 64. Once the device 252 is positioned within the valve 64, the valve is imaged using imaging (e.g., fluoroscopy). The extensions 256 provide an indication of the circumference of the annulus 68.

[0839] The device 252 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter. Additionally, the device 252 is made of a radiopaque material to facilitate fluoroscopic visualization. In some applications, the plurality of extensions 256 are used to view the tissue of the valve annulus 68 and the tissue coupled thereto. Additionally, the tissue of the native heart valve annulus 68 and the tissue coupled thereto are viewed by imaging the annulus marking device 252 relative to the tissue of the native heart valve annulus and by observing the plurality of extensions 256 against the tissue. For some applications, the tissue of the native heart valve annulus 68 and the tissue coupled thereto are viewed by imaging the annulus marking device 252 relative to the tissue of the native heart valve annulus and by observing the movement of the plurality of extensions 256 in response to movement of the tissue.

[0840] After positioning the device 252 within the valve 64 and under imaging, an implant including an annuloplasty structure 259 is positioned along the annulus 68, as Fig. 11BAs shown. Structure 259 includes a body portion 260, such as a tubular body portion, through which a plurality of anchors 264 are deployed. Structure 259 includes a plurality of radiopaque markers 262 positioned at corresponding longitudinal locations along structure 259. 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, so as to enable setting of a desired distance between tissue anchors along the body portion. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque material attached to or incorporated within body portion 164.

[0841] The anchors 264 are delivered to the valve 64 to anchor structure 259 to the annulus 68 by deploying each of the plurality of anchors 264 between adjacent extensions 256 of the device 252. In addition to guiding under imaging provided by the radiopaque extensions 256, the markers 262 of structure 259 also assist in the deployment of the anchors 264.

[0842] After anchoring structure 259 to the 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 in a manner such that the extensions 256 slide under the annuloplasty structure 259 implanted along the annulus 68. The annulus marking device 252 is retrieved and removed from the body of the subject.

[0843] After implantation of structure 259, the annulus marking device 252 is retrieved. Since device 252 is flexible and compressible, device 252 is constrained within a tool during retrieval of device 252 and subsequent removal of device 252 from the body of the subject. That is, for such embodiments, device 252 does not serve as an implant and is only used to guide the implantation of the annuloplasty structure 259 (i.e., the implant); rather, device 252 serves as a guide for implantation while being temporarily placed within the patient's body to be subsequently removed from the patient's body after implantation of the annuloplasty structure 259.

[0844] It should be noted that although system 250 is shown on the mitral valve 64, system 250 can be used on any heart valve (such as the tricuspid valve) or any other tissue of a subject.

[0845] Now refer to Fig. 12A -B, Fig. 12A-Figure B is a schematic illustration of a system 270 for facilitating imaging of cardiac tissue during implantation of a cardiac implant, the system 270 including an annulus marking device that includes a mapping catheter 272. As shown, the mapping catheter 272 is introduced percutaneously (e.g., transvascularly) toward the mitral valve 64. 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 a plurality of mapping subunits 274. For some applications, the subunits 274 include electrodes, and the electrodes are used to perform electrophysiological mapping of the valve 64 using an electroanatomical mapping system. 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 radiopaque material, and imaging is performed, such as under fluoroscopy.

[0846] As Fig. 12B shown, once a map of the valve 64 is generated using the mapping catheter 272, the map is used as a guide to place an implant (e.g., an annuloplasty structure 271) at the valve 64. In some applications, the structure 271 includes 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 includes a plurality of radiopaque markers 273 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, so as to enable setting of a desired distance between tissue anchors along the body portion. For some applications, the markers comprise radiopaque ink. For some applications, the markers include radiopaque material attached to or included in the body portion 164 or additional radiopaque material, markers, etc.

[0847] For some applications, the mapping catheter 272 is removed before implanting the structure 271, and the structure 271 is implanted under the guidance of a map 276 generated by the mapping catheter 272, where the map 276 can be stored and displayed by an imaging device. For some applications, the mapping catheter 272 remains at the annulus 68 during implantation of the structure 271 and is observed under fluoroscopy. For some applications, the mapping catheter 272 facilitates observing and mapping the tissue of the native cardiac valve annulus and tissue coupled thereto using the mapping catheter 272. For some applications, the mapping catheter 272 facilitates observing and mapping the tissue of the native cardiac valve annulus and tissue coupled thereto by observing the mapping catheter 272 against the tissue. For some applications, the mapping catheter 272 facilitates observing and mapping the tissue of the native cardiac valve annulus and tissue coupled thereto by observing movement of the mapping catheter 272 in response to movement of the tissue.

[0848] It should be noted that although system 270 is shown on mitral valve 64, system 270 can be used on any heart valve (e.g., tricuspid valve) of an object or any other tissue.

[0849] Now referring to Fig.13 , Fig.13 is a schematic diagram of system 280 including annulus marking device 282 according to some applications. The annulus marking device 282 includes a plurality of expandable elements 286 that form the device 282 into a generally spherical shape to facilitate imaging of cardiac tissue during implantation of a cardiac implant. Device 282 includes a flexible radiopaque material, such as nitinol or stainless steel, that facilitates collapse and expansion of device 282.

[0850] As shown, device 282 aids in imaging the implantation of a cardiac implant (e.g., annuloplasty structure 288), as shown. Structure 288 includes a body portion 290 that includes a flexible material and has a longitudinal axis that travels along the length of body portion 290 (e.g., when the body portion is straightened). Body portion 290 includes radiopaque markers 292 to assist in imaging for accurately delivering anchor 296 to annulus 68 to anchor implant 288 to the tissue of annulus 68.

[0851] Annulus marking device 282 is delivered using delivery tool 284, which is configured to deliver device 282 to the left atrium in a compressed state. Device 282 is configured to expand from its compressed state once deployed from the lumen of tool 284. Annulus marking device 282 can be retrieved when delivery tool 284 is removed from the object. That is, once the cardiac implant has been implanted at annulus 68, device 282 is constrained within the lumen of tool 284. Device 282 can be delivered percutaneously, thoracoscopically through the chest, or using open heart surgery techniques. If delivered percutaneously, device 282 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous vascular access can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof) into the femoral vein or jugular vein. For some applications, device 282 includes a wire.

[0852] Once inside 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 position of the native cardiac valve annulus 68 of the native cardiac valve 64. It should be noted that although device 282 is being used in the left atrium, device 282 can be used in the right atrium, left ventricle, and right ventricle.

[0853] Multiple expandable elements 286 cooperate to form the annulus marking device 282 into a generally spherical shape. As shown, the multiple expandable elements 286 include multiple curved lines. For some applications, the multiple expandable elements 286 surround a central axis 285. The proximal and distal ends of each expandable element 286 are coupled to the shaft 285.

[0854] The combined proximal diameter Di1 of the proximal ends of the multiple expandable elements 286 is equal to the combined distal diameter Di3 of the distal ends of the multiple expandable elements 286. The combined intermediate diameter Di2 of the multiple expandable elements 286 is greater than the combined proximal diameter Di1 and greater than the combined distal diameter Di3.

[0855] Then, fluoroscopy is used to image the annulus 68. In some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart valve annulus 68 and the tissue coupled thereto by observing the multiple expandable elements 286 against the tissue. For some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart valve annulus 68 and the tissue coupled thereto by observing the movement of the multiple expandable elements 286 in response to tissue movement. For any application, the annulus marking device 282 is imaged relative to the tissue of the native heart valve annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0856] Now refer to Figure 3A-3B and Fig.13 For some applications, the annulus marking device 282 is coupled to multiple 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 valve annulus 68 and the tissue coupled thereto by observing the multiple expandable elements 286 and the radiopaque elements or filaments 99 against the tissue. For some applications, the annulus marking device 282 is imaged relative to the tissue of the native heart valve annulus 68 and the tissue coupled thereto by observing the movement of the multiple expandable elements 286 and the filaments 99 in response to tissue movement. For any application, the annulus marking device 282 and the radiopaque elements or filaments 99 are imaged relative to the tissue of the native heart valve annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0857] Again refer to Fig.13 Under the guidance of fluoroscopy, the annulus marking device 282 is used as a guide to implant the annuloplasty structure 288. The annuloplasty structure 288 is positioned between the annulus marking device 282 and the atrial wall 122. The corresponding anchors 296 are deployed to anchor the structure 288 at locations along the annulus 68 between the consecutive curved lines of the elements 286.

[0858] Once the annuloplasty structure 288 is implanted, the device 282 is constrained within the tool 284 and removed from the subject.

[0859] After implantation of the structure 288, the annulus marking device 282 is retrieved. Since the device 282 is flexible and compressible, the device 282 is constrained within the 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 serve as an implant and is only used to guide the implantation of the annuloplasty structure 288 (i.e., the implant); rather, the device 282 serves as a guide for implantation while being temporarily placed within the patient's body for subsequent removal from the patient's body after implantation of the annuloplasty structure 288.

[0860] It should be noted that although the system 280 is shown on the mitral valve 64, the system 280 can be used on any heart valve (e.g., the tricuspid valve) or any other tissue of the subject.

[0861] Now referring Fig.14 , Fig.14 FIG. is a schematic illustration of a system 300 including an annulus marking device 302 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 generally bulbous shape to facilitate imaging of cardiac tissue during implantation of a cardiac implant. The plurality of expandable elements 301 of the device 302 include braided radiopaque fibers that include a flexible radiopaque material, such as nitinol or stainless steel, that facilitates collapse and expansion of the device 302. The plurality of expandable elements 301 of the device 302 together present a reticulum.

[0862] As shown, the device 302 aids in imaging the implantation of a cardiac implant (e.g., an annuloplasty structure 308), as shown. The structure 308 includes a body portion 307 that includes a flexible material and has a longitudinal axis (e.g., when the body portion is straightened) that travels along the length of the body portion 307. The body portion 307 includes radiopaque markers 309 to assist in imaging for accurately delivering the anchor 310 to the annulus 68 to anchor the structure 308 to the tissue of the annulus 68. The structure 308 is delivered using a delivery tool 305.

[0863] Delivery tool 304 is used to deliver annulus marking device 302, which is configured to deliver device 302 in a compressed state to the left atrium. Device 302 is configured to expand from its compressed state once deployed from the lumen of tool 304. Annulus marking device 302 can be retrieved when delivery tool 304 is removed from the subject. That is, once the cardiac implant has been implanted at annulus 68, device 302 is constrained within the lumen of tool 304. Device 302 can be delivered percutaneously, thoracoscopically through the chest, or using open-heart surgical techniques. If delivered percutaneously, device 302 can be made of a superelastic material (e.g., nitinol or stainless steel) such that it can be folded and collapsed so that it can be delivered in a catheter and then self-expand into a desired shape and tension when released from the catheter. For example, percutaneous access can be achieved by conventional methods under image guidance (e.g., fluoroscopy, ultrasound, magnetic resonance, computed tomography, or a combination thereof) into the femoral vein or jugular vein. For some applications, device 302 includes wires.

[0864] It should be noted that although device 302 is shown being delivered via the aorta, any suitable delivery path can be used to deliver device 302 into the atrium.

[0865] Once inside the atrium, a 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 native cardiac valve annulus 68 of native heart valve 64. It should be noted that although device 302 is being used in the left atrium, device 302 can be used in the right atrium, left ventricle, and right ventricle.

[0866] Then fluoroscopy is used to image annulus 68. In some applications, annulus marking device 302 is imaged with respect to the tissue of native cardiac valve annulus 68 and the tissue coupled thereto by observing the plurality of expandable elements 301 against the tissue. For some applications, annulus marking device 302 is imaged with respect to the tissue of native cardiac valve annulus 68 and the tissue coupled thereto by observing the movement of the plurality of expandable elements 301 in response to movement of the tissue. For either application, annulus marking device 302 is imaged with respect to the tissue of native cardiac valve annulus 68, the tissue of at least one leaflet, and the tissue of atrial wall 122.

[0867] Now refer to Figure 3A-3B and Fig.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, etc. 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 valve annulus 68 and the tissue coupled thereto by observing the plurality of expandable elements 301 and the radiopaque elements or filaments 99 against the tissue. For some applications, the annulus marking device 302 is imaged relative to the tissue of the native heart valve annulus 68 and the tissue coupled thereto by observing the movement of the plurality of expandable elements 301 and the radiopaque elements or filaments 99 in response to tissue movement. For any application, the annulus marking device 302 and the radiopaque elements or filaments 99 are imaged relative to the tissue of the native heart valve annulus 68, the tissue of at least one leaflet, and the tissue of the atrial wall 122.

[0868] Under fluoroscopic guidance, the annulus marking device 302 is used as a guide to implant the annuloplasty structure 308. The annuloplasty structure 308 is positioned between the annulus marking device 302 and the atrial wall 122. The corresponding anchor 310 is deployed to anchor the structure 308 at a location along the annulus 68 between the consecutive bends of the elements 301.

[0869] Once the annuloplasty structure 308 is implanted, the device 302 is constrained within the tool 304 and removed from the subject.

[0870] After the implantation of the structure 308, the annulus marking device 302 is retrieved. Since the device 302 is flexible and compressible, the device 302 is constrained within the 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 is not used as an implant and is only used to guide the implantation of the annuloplasty structure 308 (i.e., the implant); rather, the device 302 is used as a guide for implantation while being temporarily placed within the patient's body to be subsequently removed from the patient's body after the implantation of the annuloplasty structure 308.

[0871] It should be noted that although the system 300 is shown on the mitral valve 64, the system 300 can be used on any heart valve (e.g., tricuspid valve) or any other tissue of a subject.

[0872] Now referring to Fig.15 , Fig.15Schematic diagram of a system 320 including an annulus marking device 321 for some applications, the annulus marking device 321 including a guidewire 324 that travels in parallel with an implant (e.g., an annuloplasty structure 322). The guidewire 324 extends from within a delivery tool 323 and is disposed between leaflets 123 (e.g., posterior and anterior leaflets), typically at the commissure of the valve. The guidewire 324 is at least partially rigid and provides resistance, which facilitates the positioning of the structure 322. The guidewire 324 can also provide tactile feedback to the operator.

[0873] The structure 322 includes a body portion that includes a flexible material and has a longitudinal axis (e.g., when the body portion is straightened) that travels along the length of the body portion. The body portion includes radiopaque markers 325 to assist in imaging for accurately delivering an anchor to the annulus 68 in order to anchor the structure 322 to the tissue of the annulus 68.

[0874] In addition to providing tactile feedback, the guidewire 324 can also facilitate the positioning of the annuloplasty structure 322 by facilitating imaging (e.g., fluoroscopy). For example, the presence and / or shape of the guidewire 324 (e.g., bent due to being pressed into the commissure) is visible in fluoroscopic imaging and can be used to facilitate the identification of the orientation and angle of the annuloplasty structure 322 relative to the tissue.

[0875] The guidewire 324 extends proximally through the tool 323 and can extend outside of the subject's body. The guidewire 324 can be removed by pulling after the deployment of one or more tissue anchors in order to anchor the structure 322.

[0876] Now refer to Figure 3A-3B and Fig.15 . It should be noted that the guidewire 324 can be coupled to a plurality of filaments 99 and can be shaped in any suitable shape. For example, the distal end of the guidewire 324 can be helical.

[0877] It should be noted that although the system 320 is shown on the mitral valve 64, the system 320 can be used on any heart valve (e.g., tricuspid valve) or any other tissue of a subject.

[0878] Now refer to Fig.16A -C, Fig.16A -C is a schematic diagram of a system 350 including an annulus marking device 352 for some applications, the annulus marking device 352 including a tubular stent body 354 having a central longitudinal axis 351 and a frame 356 coupled to the proximal end of the tubular stent body 354 and protruding away from the longitudinal axis 351 of the stent body 354. The annulus marking device 352 is configured to be placed within a native heart valve of a subject, such as the mitral valve 64 (as shown), the tricuspid valve, or any other heart valve.

[0879] Frame 356 is configured to be placed along at least a portion of the circumference of annulus 68 of valve 64. In some applications, prior to implantation of the implant along annulus 68, an annulus marking device is positioned within valve 64. For some applications, the tubular stent body 354 includes two or more leaflets to regulate blood flow when device 352...

Claims

1. A system for use with an object, the system comprising: an implant configured to be placed along a native cardiac valve annulus of a native cardiac valve of the object, 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; and an annulus marking device, the annulus marking device including: an expandable radiopaque braided mesh that is expandable from a collapsed state to a frustoconical shape; and two or more pull wires coupled to the expandable radiopaque braided mesh, the two or more pull wires configured to be pulled to transform the expandable radiopaque braided mesh from the frustoconical shape into a shape in which the expandable radiopaque braided mesh presents (1) an inclined upper portion configured to be positioned within an atrium of the heart of the object, (2) a raised convex portion configured to be positioned above the cardiac valve, (3) a constricted portion for positioning within the cardiac valve, and (4) a flared portion configured to expand within a ventricle of the heart of the object.

2. The system according to claim 1, wherein the annulus marking device is removable from the object after implantation of the implant.

3. The system according to any one of claims 1-2, wherein the body portion includes a plurality of radiopaque markers at respective locations along the body portion.

4. The system according to any one of claims 1-2, wherein the raised convex portion has a greater diameter than other portions of the annulus marking device.

5. The system according to any one of claims 1-2, wherein the inclined upper portion is configured such that the implant is slidable toward the annulus.

Images