Valve delivery system

Abstract

To provide delivery systems and methods for delivering a valve anchor and a valve prosthesis to a native valve annulus.SOLUTION: The anchor can be deployed near the native valve annulus with a tether attached to the anchor. A portion of the tether can be positioned inferior to the deployed anchor in an inverted configuration for advantageous positioning for adjusting the anchor position and / or deployment of the valve prosthesis. A positioning tool can be tracked over the tether and used to properly position the anchor. The positioning tool can be configured to transition to a stiffened state that includes one or more bends configured to allow efficient positioning of the deployed anchor and to provide room for deploying the valve prosthesis. Once the anchor is properly positioned, the valve prosthesis can be deployed within the native valve annulus and within the valve anchor.SELECTED DRAWING: Figure 2E

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 048,963, entitled "VALVE DELIVERY SYSTEM," filed July 7, 2020, the entire contents of which are incorporated herein by reference. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Summary of the Invention [Problem to be solved by the invention]

[0002]

[0003] Blood flow between the heart chambers (i.e., the atrioventricular chambers) is controlled by natural valves: the mitral, aortic, pulmonary, and tricuspid valves. Each of these valves is a passive one-way valve that opens and closes in response to different pressures. Patients suffering from valvular disease have abnormal anatomical and / or functional properties of at least one valve. For example, a valve can suffer from valvular insufficiency, also known as regurgitation, when it fails to close completely, allowing blood to flow backward. Valvular stenosis can prevent a valve from opening normally. Other diseases can also lead to valve dysfunction. While medications may be used to treat these diseases, defective valves often need to be repaired or replaced at some point in a patient's life. Existing valves and surgical repair and / or replacement procedures can be relatively high-risk, have limited lifespans, and / or be highly invasive. While some minimally invasive transcatheter options are available, they are generally limited to aortic valve procedures, offer limited flexibility for individual patients, and often require longer than desirable implantation times. Therefore, it would be desirable to provide a less invasive procedure for repair and replacement of heart valves, including the mitral valve, a faster surgical method, and / or a prosthetic valve that can accommodate a wide variety of individual patients.

[0003]

[0004] Additionally, existing valve repair / replacement procedures are often complex and lengthy. Currently available procedures often require the placement of multiple components, e.g., a prosthetic valve and mechanisms for securing it to native anatomy. Such procedures typically use multiple delivery catheters to carry the various components and separate delivery of each component to the valve, which can be time-consuming, complicated, and / or dangerous (especially when the components are delivered sequentially). For example, some devices include rotating fixation elements for capturing native anatomy, such as chordae tendineae, to reduce delivery time. However, such fixation elements can capture and pull on the chordae tendineae when rotated, often intentionally, which can torque or otherwise stress and damage the chordae upon deployment of the anchor element, potentially resulting in the need for additional medical intervention in the patient. Additionally, such fixation elements may require extrusion from a low-profile (e.g., elongated) delivery configuration to an expanded configuration at or near the native valve. In at least some cases, extrusion of the fixation elements can be complicated and may not ensure deployment in the correct expanded configuration relative to the delivery device and / or native anatomy. Incorrect deployment can result in additional time to retract and redeploy the fixation elements, a more complicated fixation procedure, and / or damage to natural tissue. Therefore, it would be desirable to provide a faster, less complicated, less risky, and more reliably deployable valve assembly for valve replacement and repair. [Means for solving the problem]

[0004]

[0005] Described herein are delivery systems and methods for delivering a valve anchor and a prosthetic valve to a native valve annulus. The anchor can have a helical shape and can be deployed around the chordae tendineae and / or leaflets of the native valve annulus. A tether (i.e., a string) connected to the anchor can extend outside the heart and / or the patient's body. A valve delivery device can track over the tether to expand the prosthetic valve into the native valve annulus and into the valve anchor. Opposing forces between the prosthetic valve and the anchor cause the prosthetic valve to expand. The valve can be fixed in place within the annulus of the native valve.

[0005]

[0006] Prior to deployment of the prosthetic valve, a positioning tool can be used to properly adjust the position of the deployed valve anchor toward the selected position. For example, it may be preferable for the valve anchor to be axially aligned with the center of the prosthetic valve when the prosthetic valve is expanded and deployed. It may also be desirable for the valve anchor to be as close as possible to the plane of the native annulus, which may require lifting the valve anchor from its initially deployed position. At least a portion of the tether can be positioned below the deployed anchor before the positioning tool is followed, allowing the positioning tool to be advantageously positioned to adjust the anchor position. The tether can be positioned at least partially within the ventricle in an inverted configuration. The positioning tool can be configured to efficiently transfer force from a sub-annular position to the deployed anchor. The stiffened state is then transitioned to (i.e., moved to) a stiffened state that includes one or more bends. It can be configured as follows:

[0006]

[0007] According to some embodiments, a method for treating a diseased native valve in a patient includes surrounding the chordae tendineae of the diseased native valve with an anchor having a tether attached thereto; translating (i.e., moving) a portion of the tether through the annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart with the anchor positioned around the chordae tendineae, wherein the translation of the tether causes the tether to form a bend in the second chamber; translating the tether; causing a valve delivery device to follow over the tether; and releasing a prosthetic valve from the valve delivery device into the anchor within the annulus of the diseased native valve.

[0007]

[0008] In these embodiments, the method may further include delivering an anchor to the diseased native valve with an anchor delivery device including a steerable catheter. In these embodiments, translating a portion of the tether through the annulus of the diseased native valve may include advancing the steerable catheter toward a surface of the anchor, advancing the tether while maintaining attachment to the anchor to create slack in the tether that wraps at least partially within the first chamber, and advancing the steerable catheter beyond the surface of the anchor to position at least a portion of the tether in the second chamber. In these embodiments, advancing the steerable catheter may include advancing the steerable catheter to a position near the apex of the second chamber. In these embodiments, the method may further include retracting the anchor delivery device from the diseased native valve. In these embodiments, the anchor delivery device may further include an anchor guide configured to translate within the steerable catheter, the anchor guide including an internal lumen for accommodating the anchor. In these embodiments, the anchor guide may assume a curved shape upon deployment of the anchor from the anchor guide. In these embodiments, the tether can exhibit a generally U-shaped bend within the second chamber when in the bent configuration. In these embodiments, positioning the tether in the bent configuration can include distally translating the tether relative to the steerable catheter to provide an extended tether length within the second chamber. In these embodiments, following the valve delivery device over the tether can include advancing the valve delivery catheter through the annulus of the diseased native valve. In these embodiments, following the valve delivery device over the tether can include deploying a positioning tool over the bent tether. In these embodiments, the method may further include advancing the positioning tool distally until the distal end of the positioning tool contacts a fitting attached to the proximal end of the anchor. In these embodiments, the method may further include applying a compressive force along the positioning tool to stiffen the positioning tool. In these embodiments, applying a compressive force may include pulling the tether proximally to tension the tether. In these embodiments, pulling the tether proximally to tension the tether may further include using a handle to apply a controlled amount of tension to the tether. In these embodiments, applying a compressive force causes the positioning tool to assume a substantially U-shaped bend below the valve annulus relative to the anchor. In these embodiments, the method may further include releasably attaching the distal end of the positioning tool to the anchor. In these embodiments, the method may further include using the positioning tool to adjust the position of the anchor relative to the diseased native valve. In these embodiments, adjusting the position of the anchor may include pulling the positioning tool proximally to move the anchor toward the annulus of the diseased valve. In these embodiments, the position of the anchor can be adjusted to be closer to the annulus of the diseased native valve. In these embodiments, the position of the anchor can be adjusted so that the anchor is located in a plane perpendicular to the plane of the distal end of the valve delivery device. In these embodiments, bending the tether within the second chamber can include inverting the tether within the second chamber. In these embodiments, the method can further include delivering the anchor to the diseased native valve with an anchor delivery system including a steerable catheter.

[0008]

[0009] According to some embodiments, a delivery system for delivering a prosthetic valve to a diseased valve of the heart includes a tether configured to connect to a valve anchor, the tether further configured to extend from a location external to the heart through at least a first chamber of the heart into a second chamber of the heart, and a valve delivery catheter configured to extend over the tether into the second chamber to hold the prosthetic valve therein and release the prosthetic valve within the valve anchor with the tether connected to the valve anchor.

[0009]

[0010] In these embodiments, the tether can be configured to assume a generally U-shape within the second chamber of the heart. In these embodiments, the tether can be releasably attached to the valve anchor. In these embodiments, the distal end of the tether can be configured to be releasably attached to the proximal end of the valve anchor. In these embodiments, the valve anchor can have a helical shape, and the valve delivery catheter is configured to extend through a central opening in the valve anchor to align the prosthetic valve prior to release of the prosthetic valve. In these embodiments, the valve delivery catheter can be configured to axially align a central portion of the prosthetic valve with the diseased valve. In these embodiments, the distal end of the valve delivery catheter can include a nosecone having a port sized and shaped to pass the tether therethrough, the port having a central axis coaxial with the central axis of the valve delivery catheter. In these embodiments, the system can further include a positioning tool configured to extend through the valve delivery catheter and over the tether, the positioning tool configured to connect to the valve anchor and control the position of the valve anchor after it is deployed in the heart. In these embodiments, the positioning tool can include one or more regions configured to bend into a predetermined shape. In these embodiments, the regions can have a relatively reduced bending stiffness. In these embodiments, one or more regions can include one or more cutouts configured to allow the region to bend into a predetermined shape when a compressive force is applied to the positioning tool. In these embodiments, the one or more regions can be configured to bend into a predetermined shape when a tether is tensioned within those regions. In these embodiments, the first region can be configured to transition from a straight shape to a U-shape. In these embodiments, the second region can be configured to transition from a straight shape to a curved shape that bends radially inward toward the center of the valve anchor. In these embodiments, the positioning tool can be configured to bend into a predetermined shape when a compressive force is applied to the one or more regions. The positioning tool may include a distal edge configured to engage a proximal edge of the valve anchor or a proximal edge of a fitting attached to the proximal end of the valve anchor. In these embodiments, the distal edge of the positioning tool may be beveled and configurable to engage a correspondingly beveled edge of the proximal edge of the valve anchor or a proximal edge of a fitting attached to the proximal end of the valve anchor. In these embodiments, the system may further include an anchor delivery device configured to deploy the valve anchor within the heart prior to delivery of the prosthetic valve with the valve delivery catheter. In these embodiments, the anchor delivery catheter may include a steerable catheter having a distal end configured to bend to position the valve anchor within the heart. In these embodiments, the anchor delivery catheter may be configurable to extend over the tether. In these embodiments, the anchor delivery device may include a steerable catheter configured to position the tether from a first chamber of the heart to a second chamber of the heart. In these embodiments, the steerable catheter may be configurable to position the tether in an inverted configuration within the second chamber of the heart. In these embodiments, the steerable catheter may be configurable to form a U-shaped portion of the tether within the second chamber of the heart. In these embodiments, the anchor delivery catheter can be configured to extend through a central opening in the valve anchor. In these embodiments, the valve delivery catheter can include an inner shaft and an outer sheath, with the prosthetic valve compressed between the inner shaft and the outer sheath. In these embodiments, the inner shaft can be configured to house a positioning tool configured to adjust the position of the valve anchor once the valve anchor is wrapped around the chordae tendineae of the diseased valve. In these embodiments, the positioning tool can be configured to translate within the inner shaft and extend from the distal end of the valve delivery catheter. In these embodiments, proximal retraction of the valve delivery catheter can be configured to retract proximally to expand the prosthetic valve.

[0010]

[0011] According to some embodiments, a delivery system for delivering a prosthetic valve to a diseased valve of the heart includes: a tether configured to be connected to a valve anchor that surrounds at least a portion of the chordae tendineae of the diseased valve, the tether further configured to extend from a location external to the heart through at least a first chamber of the heart and into a second chamber of the heart; and a positioning tool configured to adjust the position of the valve anchor that surrounds at least a portion of the chordae tendineae, the positioning tool including an elongated body configured to follow over the tether and contact a proximal portion of the valve anchor, the positioning tool including one or more regions configured to bend when an axial compressive force is applied to the positioning tool to configure the positioning tool to a predetermined shape.

[0011]

[0012] In these embodiments, the predetermined shape may include an inverted portion configured to be positioned subannularly relative to the valve anchor within the second chamber of the heart. In these embodiments, the predetermined shape may include a generally U-shaped bend. In these embodiments, the one or more regions may include one or more notches along a portion of the circumference of the elongate body, where compression of the positioning tool narrows a gap width of the one or more notches. In these embodiments, the predetermined shape of the positioning tool may include a second bend at the distal end of the positioning tool that bends radially inward toward the center of the valve anchor. In these embodiments, the system may further include a valve delivery catheter configured to house the positioning tool therein, the positioning tool configured to translate within the valve delivery catheter and extend from the distal end of the valve delivery catheter. In these embodiments, the valve delivery catheter may further house a prosthetic valve therein. In these embodiments, the valve delivery catheter may include an inner shaft configured to house the positioning tool within a central opening of the prosthetic valve. In these embodiments, proximal retraction of the valve delivery catheter may expand the prosthetic valve. In these embodiments, the predetermined shape can be configured to transmit a force applied to the valve anchor in a direction toward the plane of the diseased valve, so as to move the valve anchor toward the plane of the diseased valve. In these embodiments, the positioning tool can be configured to bend and stiffen when the tether is pulled proximally. In such a manner, the positioning tool can be configured to bend and stiffen when the positioning tool is pushed distally.

[0012]

[0013] In some embodiments, a method for treating a diseased native cardiac valve includes deploying an anchor from an anchor delivery catheter so that the anchor surrounds the chordae tendineae of the diseased valve, where after the anchor is deployed, a tether extends from a distal end of the anchor delivery catheter and is attached to the anchor; translating the distal end of the anchor delivery catheter from a first chamber of the heart to a second chamber of the heart, where the distal end of the anchor delivery catheter is translated through a central opening of the deployed anchor; advancing the tether through the anchor delivery catheter until a loop of the tether is positioned within the second chamber of the heart; and retracting the tether within the anchor delivery catheter until slack is removed from the tether, where removal of the slack releases tension in the tether and causes the tether to assume an everted configuration within the second chamber of the heart.

[0013]

[0014] In these embodiments, the method may further include retracting the anchor delivery catheter from the heart. In these embodiments, the method may further include causing a valve delivery catheter to trail over the tether, the valve delivery catheter having a prosthetic valve stored therein. In these embodiments, causing the valve delivery catheter to trail over the tether may include deploying a positioning tool on a portion of the tether into a second chamber of the heart. In these embodiments, the positioning tool may be advanced until a distal end of the positioning tool engages with a fitting attached to a proximal end of the anchor. In these embodiments, the method may further include adjusting the position of the deployed anchor by translating the positioning tool engaged with the anchor. In these embodiments, adjusting the position of the deployed anchor may include moving the anchor closer to the annular plane of the diseased valve. In these embodiments, the method may further include releasing the prosthetic valve from the valve delivery catheter into a central opening of the anchor within the annulus of the diseased native valve. In these embodiments, the tether may include a U-shaped bend in the second chamber of the heart when the tether is in the inverted configuration. In these embodiments, deploying the anchor from the anchor delivery catheter can include deploying the anchor from a distal end of an anchor guide, the anchor guide being positioned within the anchor delivery catheter. In these embodiments, the method can further include translating the anchor guide distally relative to the anchor delivery catheter. In these embodiments, the method can further include causing the anchor guide to assume a curved shape configured to facilitate deployment of the anchor around the chordae tendineae. In these embodiments, the method can further include bending the anchor delivery catheter to steer the distal end of the anchor delivery catheter through the central opening of the anchor.

[0014]

[0015] According to some aspects, a delivery system for delivering a prosthetic valve to a diseased valve includes a delivery catheter including an outer sheath and a hollow inner shaft extending therethrough and defining a tether lumen configured to receive a tether, and a nosecone axially aligned with the tether lumen and including a port at a distal end configured to receive the tether, the nosecone reversibly mating with the distal end of the delivery catheter and extending from a distal portion of the delivery catheter and configured to retain the prosthetic valve within the delivery catheter.

[0015]

[0016] In these embodiments, the tether lumen is positionable coaxially with the outer sheath. In these embodiments, the port is positionable coaxially with the outer sheath when the nosecone is coupled to the delivery catheter. In these embodiments, the delivery system may further include an elongated positioning tool within the tether lumen, through the port, and over the tether to the distal end of the tether, configured to adjust the orientation of the valve anchor relative to the patient's anatomy. In these embodiments, the elongated positioning tool includes at least two regions that are preferentially bendable for adjusting the orientation of the valve anchor. In these embodiments, adjusting the orientation may include forming a first predetermined bend and a second predetermined bend in a first region and a second region of the at least two regions. In these embodiments, the first predetermined bend or the second predetermined bend may comprise an angle of about 120 degrees to about 310 degrees. In these embodiments, the first predetermined bend or the second predetermined bend may have an angle of about 70 degrees to about 100 degrees. In these embodiments, the first predetermined bend or the second predetermined bend may have a radius of curvature of about 2 millimeters (mm) to about 20 mm. In these embodiments, the at least two regions may have a relatively reduced compressive stiffness relative to the remainder of the positioning tool. In these embodiments, the at least two regions are formable to bend when a compressive force is applied to the positioning tool along the longitudinal axis. In these embodiments, the first region of the at least two regions may be spaced apart from the second region along the longitudinal axis of the positioning tool. In these embodiments, a first region of the at least two regions can be spaced apart from a second region along an azimuthal axis (i.e., a horizontal axis) of the positioning tool. In these embodiments, the at least two regions can be located distal to the distal end of the delivery catheter when the positioning tool is extended to the distal portion of the tether. In these embodiments, the at least two regions can include a plurality of notches in the outer wall of the positioning tool. In these embodiments, the distal end of the positioning tool can be shaped and sized to interact with the distal portion of the tether. In these embodiments, the distal end of the positioning tool can be shaped and sized to interact with the proximal end of the distal portion of the tether. In these embodiments, the distal end of the positioning tool can include a ramp shaped and sized to interact with a corresponding ramp at the proximal end of the distal portion of the tether. In these embodiments, the delivery system may further include a valve delivery member having an inner shaft defining a valve delivery member lumen shaped and sized for (a) placement within the distal portion of the delivery catheter and relative movement between the valve delivery member and the delivery catheter, and (b) for carrying a prosthetic valve, and configured to receive a tether.In these embodiments, the valve delivery member may include a nosecone and the port is the distal end of the valve delivery member lumen.

[0016]

[0017] According to some aspects, a delivery system for delivering a prosthetic valve to a diseased valve includes an outer shaft, a valve delivery member at a distal end of the outer sheath, and a hollow inner shaft positioned within the outer shaft and the valve delivery member, the hollow inner shaft being coaxial with the outer shaft and configured to pass a tether through it.

[0017]

[0018] According to some embodiments, a delivery system for delivering a prosthetic valve to a diseased valve includes a delivery catheter including an outer sheath defining a valve lumen sized to carry the prosthetic valve in a collapsed state, an inner shaft extending through the outer sheath and along a central axis of the outer sheath, the inner shaft defining a tether lumen configured to receive a tether, and a nosecone including a port at a distal end coaxial with the tether lumen, the nosecone coupleable to the distal end of the delivery catheter to retain the prosthetic valve within the delivery catheter, the delivery catheter and nosecone being separable for deployment of the prosthetic valve, the deployment including translation of the tether lumen and / or the port relative to the tether.

[0018]

[0019] In these embodiments, the tether lumen can be positioned along the central axis of the delivery catheter. In these embodiments, the inner shaft can be coaxial with the outer sheath. In these embodiments, the port can be located at the center of the distal end of the nosecone. In these embodiments, the tether lumen and / or port can be configured for translation relative to the tether while the tether is maintained in a substantially fixed position. In these embodiments, the delivery system can further include a positioning tool having an elongate body with a proximal end for extending to the proximal end of the delivery catheter and a distal end for extending to the distal end of the tether, the positioning tool passing through the port within the tether lumen and along the tether. The port is configured to couple with the distal end of the tether to translate relative to the tether and maintain the tether in a substantially fixed position. In these embodiments, the tether lumen is configurable for proximal translation relative to the tether for deployment of the prosthetic valve. In these embodiments, the port is configurable for distal translation relative to the tether for deployment of the prosthetic valve. In these embodiments, the delivery system can further include a valve delivery member, the valve delivery member comprising an elongate body having an outer wall shaped and sized (a) for placement within a distal portion of a delivery catheter and relative movement between the valve delivery member and the delivery catheter, and (b) for carrying the prosthetic valve, the valve delivery member having an inner shaft coaxial with the outer wall and defining a valve delivery lumen therethrough, the valve delivery lumen configured to receive the tether. In these embodiments, the valve delivery member can include a nosecone, and the port forms the distal end of the valve delivery member lumen. In these embodiments, the prosthetic valve is configurable for expanding to an expanded state upon deployment of the prosthetic valve.

[0019]

[0020] According to some embodiments, a method for treating a diseased native valve in a patient includes following a delivery device over a tether coupled to an anchor near the native valve annulus of the heart into a first chamber of the heart, further following the delivery device over the tether into a second chamber of the heart to position a valve capsule carried by the delivery device beyond the native valve annulus, and exposing the valve capsule to deploy a prosthetic valve.

[0020]

[0021] In these embodiments, the method may further include advancing the tether into the second chamber while maintaining the coupling with the anchor. In these embodiments, advancing the tether may include forming a first bend and a second bend in the tether within the second chamber. In these embodiments, one of the first bend and the second bend may comprise an angle of about 120 degrees to about 310 degrees. In these embodiments, advancing the tether may be between following the delivery device into the first chamber and following the delivery device into the second chamber. In these embodiments, advancing the tether may include advancing through an inner diameter of the anchor. In these embodiments, advancing may be such that a majority of the tether extending from the delivery device is beneath the valve annulus. In these embodiments, the anchor may initially be located at a first position, and the method may include moving the anchor to a second position. In these embodiments, moving the anchor may be between following the delivery device into the second chamber and exposing the valve capsule. In these embodiments, the method may further include tracking the positioning tool over the tether so that the distal end of the positioning tool is positioned near the junction of the tether and the anchor. In these embodiments, the distal end of the positioning tool can abut the distal end of the tether. In these embodiments, moving the anchor may include compressing at least a portion of the positioning tool and / or tensioning the tether. In these embodiments, moving the anchor may include adjusting at least one of the height or angle of the distal end of the positioning tool so that at least a portion of the anchor is substantially parallel to the plane of the native valve annulus. In these embodiments, the second position may be closer to the native valve annulus than the first position. In these embodiments, tracking the delivery device into the first chamber may include inserting the proximal end of the tether into a port located at the distal end of the delivery device. In these embodiments, the port may be positioned coaxially with the outer sheath of the delivery device.

[0021]

[0022] According to some embodiments, a method for treating a diseased native valve in a patient includes coaxially following a delivery device that coaxially carries a prosthetic valve along a tether having a distal end coupled to an anchor near the heart's native valve annulus into a first chamber of the heart, further coaxially following the delivery device over the tether into a second chamber of the heart to position the prosthetic valve beyond the native valve annulus, and exposing the prosthetic valve for deployment.

[0022]

[0023] In these embodiments, the coaxial tracking can be through a port in a nosecone coupled to the distal end of the delivery device. In these embodiments, the coaxial tracking can be through a lumen of a valve delivery member that carries the prosthetic valve within the delivery device. In these embodiments, during coaxial tracking, the proximal end of the tether can extend from the portion of the delivery device that is external to the patient.

[0023]

[0024] These and other aspects are described herein.

[0024]

[0025] The novel features of the invention are set forth with particularity in the appended claims. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which: [Brief explanation of the drawings]

[0025] [Figure 1A]

[0026] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1B] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1C] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1D] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1E]1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1F] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 1G] 1A-1C illustrate an embodiment of a method for delivering anchors for a prosthetic valve near a native valve. [Figure 2A]

[0027] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2B] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2C] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2D] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2E] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2F] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2G] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 2H] 10A-10C illustrate one embodiment of a tether reversal procedure as part of the delivery of a prosthetic valve. [Figure 3A]

[0028] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3B] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3C] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3D] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3E]1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3F] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3G] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3H] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 3I] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-deployed anchors near the native valve annulus. [Figure 3J] 1A-1C illustrate an embodiment of a method for delivering a prosthetic valve to pre-placed anchors near the native valve annulus. [Figure 4A]

[0029] FIG. 4A illustrates an embodiment of the interaction between the distal end of the tether and the distal end of the positioning tool. [Figure 4B] FIG. 4B is a different view showing an embodiment of the interaction between the distal end of the tether and the distal end of the positioning tool. [Figure 4C] FIG. 4C is a different view illustrating an embodiment of the interaction between the distal end of the tether and the distal end of the positioning tool. [Figure 5A]

[0030] FIG. 5A illustrates an embodiment of a positioning tool and valve delivery catheter used to deliver a prosthetic valve. [Figure 5B] FIG. 5B illustrates an embodiment of a positioning tool and valve delivery catheter used to deliver the prosthetic valve. [Figure 6A]

[0031] FIG. 6A illustrates a portion of a positioning tool having an arrangement of preferentially bendable regions. [Figure 6B] FIG. 6B illustrates a portion of a positioning tool having an arrangement of preferentially bendable regions. [Figure 6C]FIG. 6C illustrates a portion of a positioning tool having an arrangement of preferentially bendable regions. [Figure 6D] FIG. 6D illustrates a portion of a positioning tool having an arrangement of preferentially bendable regions. [Figure 7A]

[0032] FIG. 7A is a perspective view showing a prosthetic valve carried within a valve delivery catheter. [Figure 7B] FIG. 7B is a perspective view showing the prosthetic valve carried within the valve delivery catheter. [Figure 7C] FIG. 7C is a cross-sectional view showing the prosthetic valve being carried within a valve delivery catheter. [Figure 7D] FIG. 7D is a cross-sectional view showing the prosthetic valve being carried within a valve delivery catheter. [Figure 8]

[0033] 1 is a flowchart illustrating a method of deploying a prosthetic valve using tethers. [Figure 9]

[0034] 10 is a flowchart illustrating a method of deploying a prosthetic valve using tethers and a positioning tool. [Figure 10A]

[0035] FIG. 10A is a side view of an exemplary positioning tool. [Figure 10B] FIG. 10B is a close-up view of an exemplary positioning tool. [Figure 11A]

[0036] FIG. 11A is a side view of another exemplary positioning tool. [Figure 11B] FIG. 11B is a close-up view of another exemplary positioning tool. [Figure 12]

[0037] 10 is a flowchart illustrating a method of delivering a prosthetic valve, including reversing the tether to cause the prosthetic valve to follow. [Figure 13A]

[0038] FIG. 13A shows images of an exemplary tether reversal procedure performed in a lamb's heart. [Figure 13B] FIG. 13B shows images of an exemplary tether reversal procedure performed in a lamb's heart. [Figure 13C] FIG. 13C shows images of an exemplary tether reversal procedure performed in a lamb's heart. [Figure 14A]

[0039] FIG. 14A shows an image of an example of the use of a positioning tool within the heart to control the axial height of an anchor. [Figure 14B] FIG. 14B shows an image of an example of the use of a positioning tool within the heart to control the axial height of the anchor. [Figure 14C] FIG. 14C shows an image of an example of the use of a positioning tool within the heart to control the axial height of the anchor. [Figure 15A]

[0040] FIG. 15A shows images of an example deployment of a prosthetic valve in a heart, illustrating the problems associated with the length of the positioning tool. [Figure 15B] FIG. 15B shows images of an example deployment of a prosthetic valve within a heart, illustrating problems associated with the length of the positioning tool. DETAILED DESCRIPTION OF THE INVENTION

[0026]

[0041] Described herein are devices and methods for use in delivering a valve frame and valve, for example, during mitral valve replacement. The devices and methods can be used in conjunction with pre-placed anchors used to deliver the valve frame. The devices and methods can be used to transition (e.g., move) the anchors from a first position away from the native annulus (e.g., in the subannular space) to a second position closer to the native annulus prior to deployment of the prosthetic valve.

[0027]

[0042] 1A-1G illustrate a method for delivering anchors for a prosthetic valve system using an anchor delivery device or system. In FIG. 1A, a transseptal puncture is performed. A guidewire 102 is then threaded through the puncture site and positioned into the left atrium 104 or across the mitral valve into the left ventricle 106. In FIG. 1B, an outer sheath 108 (also referred to as an anchor delivery catheter or steerable catheter) is tracked over the guidewire 102 until the distal end of the outer sheath 108 protrudes into the left atrium 104. In some embodiments, the outer sheath optionally includes an internal dilator 110. The guidewire 102 and internal dilator 110 (if used) are then removed from the outer sheath 108. In FIG. 1C, an inner sheath having a distally disposed anchor guide 112 is inserted into the outer sheath 108 until the distal tip of the anchor guide 112 extends into the left atrium 104. The anchor guide 112 can be configured to assume a predetermined curved shape. The anchor guide 112 can be positioned in a desired position and / or orientation by manipulating the distal end of the tube 108 and / or by rotating the inner shaft and anchor guide 112 within the tube 108. In some embodiments, the distal portion of the outer sheath 108 is bendable between a straight and a bent configuration. Such bending can be controlled, for example, at a handle operably connected to the anchor delivery catheter. In FIG. 1D , once the anchor guide 112 is positioned in a selected orientation, an anchor 114 is pushed out of the distal tip of the anchor guide 112. The geometry (e.g., curvature) of the anchor guide 112 can induce a twist in the anchor 114 during deployment.

[0028]

[0043] In FIG. 1E, the anchor guide 112 urges the anchor 114 to deploy coaxially with the distal portion of the outer sheath 108 within the atrium 104. In FIG. 1F, the entire delivery system 116 can be pushed and manipulated (e.g., via a steering mechanism within the outer sheath 108) toward the apex of the ventricle 106 and past the mitral valve. In some embodiments, counter-rotation of the anchor 114 (via counter-rotation of the inner shaft and guide 112) may assist in advancing the anchor past the mitral valve without entrapment of the chordae. Once the anchor 114 reaches a selected depth within the ventricle 106, forward rotation of the anchor 114 (via forward rotation of the inner shaft and guide 112) causes the anchor 114 to engage the mitral valve leaflets and chordae. In some embodiments, anchor 114 is deployed toward the apex (e.g., initially) to help avoid interfering with the movement of the mitral valve leaflets. In FIG. 1G, the outer and inner sheaths are removed along with anchor guide 112, leaving tether 118 in place. The tether remains attached to anchor 114 at attachment 128 and extends through the delivery channel to the exterior of the patient. Embodiments of anchor / prosthetic valve delivery methods and devices are disclosed in U.S. Patent Application No. 16 / 824,576, filed March 19, 2020, and U.S. Patent Application No. 16 / 594,946, filed October 7, 2019, the entire disclosures of which are incorporated herein by reference.

[0029]

[0044] In some embodiments, the tether attached to the anchor can function as a guidewire that a valve delivery device (also called a valve delivery catheter or valve delivery member) follows to deliver the prosthetic valve. The valve delivery device can include a lumen through which the tether follows. In some embodiments, the tether can be delivered within a chamber of the heart, such as a ventricle. The tether can be inverted or looped. For example, the tether can extend from the anchor (e.g., near the mitral valve) toward the ventricle and then be bent, curved, looped, or inverted to extend back through the mitral valve annulus (e.g., into the atrium). Inverting the tether is advantageous because it allows access to the anchor from a subannular position. In some embodiments, the tether loop is formed and / or housed within a central opening (e.g., the inner radius) of the anchor. A tether looped within the central opening of the anchor can enable coaxial delivery of the valve on the tether. Coaxial tracking of the valve delivery device on the tether can also advantageously improve advancement of the valve delivery device through the patient's anatomy. For example, the tip of the valve delivery device can be guided through a (pre-existing) puncture in the septum via the coaxial tether to improve traversal of the valve delivery device during a transseptal procedure. Coaxial delivery can also reduce the total number of devices required for valve delivery because the tether can also be used as a guidewire. Coaxial tracking of the valve delivery device on the tether is advantageous because it can improve placement of (1) the distal end of the valve delivery device relative to the chamber of the native heart valve (e.g., the left ventricle) and / or (2) the prosthetic valve relative to the annulus of the native heart valve (e.g., the mitral valve). The tether may be formed to include one or more of the following materials: stainless steel, nickel-titanium alloy (e.g., Nitinol), cobalt-chromium-nickel alloy (e.g., Elgiloy®), cobalt-chromium, polymer, or block copolymer including polyamide and polyester (e.g., Pebax®).

[0030]

[0045] 2A-2H illustrate an exemplary method of inverting the tether 118 according to some embodiments as part of anchor delivery of a prosthetic valve system within a patient. FIG. 2A shows the anchor guide 112 after it has been pushed at least partially across the mitral valve plane and used to position the anchor 114 so that it surrounds the mitral valve leaflets and / or chordae tendineae (as shown in FIG. 1F). In FIG. 2B, the distal end of the anchor guide 112 has been retracted proximally into the outer sheath 108, leaving the tether 118 exposed from the distal end of the outer sheath 108. The tether 118 can be configured to be flexible enough to bend laterally as it passes through the patient's vessels and heart, yet also stiff enough once it exits the outer sheath 108 to resist tangling when manipulated. The stiffness of the tether 118 may provide some resistance when attempting to feed the tether 118 through the central opening of the anchor 114.

[0031]

[0046] The steerable distal tip of the outer sheath 108 can be used to advance a portion of the tether 118 through the anchor 114. For example, in FIG. 2C, the steering mechanism of the outer sheath 108 is used to advance the outer sheath 108 through (e.g., coaxially) the native annulus. Further, a slack 122 in the tether 118 is created by threading the outer sheath 108. tether 118 can be advanced distally. Generally, a tether including slack can include a state of the tether in which gradual (e.g., slight) proximal retraction of tether 118 serves to shorten the length of tether 118 exposed from outer sheath 108 without exerting substantial force on anchor 114. In this context, substantial force is a force of sufficient magnitude to reposition anchor 114 relative to the native anatomy. Slack in tether 118 can cause a portion of tether 118 to form a coil or loop within atrium 104 and / or ventricle 106. While the examples shown in FIGS. 2A-2H show tether slack and loops / coils formed within the ventricles of the heart, it will be appreciated that other embodiments of the present disclosure may alternatively or additionally include tether slack and loops / coils formed within the atria.

[0032]

[0047] In FIG. 2D, the distal end of outer sheath 108 is advanced through the central opening of annulus anchor 114, past the plane of anchor 114, and further to release the loop of tether 118. 2E, the tether 118 is further advanced through the outer sheath 108 and deployed within the left ventricle 106. In FIG. 2F, the outer sheath 108 is further advanced toward the left ventricular apex. Optionally, the tether 118 is advanced through the annulus of the anchor 114. Due to the tension on the tether 118 when it is being retracted, the tether 118 may become constrained within the anchor 114. In FIG. 2G, the tether 118 is retracted proximally relative to the outer sheath 108 sufficiently to remove at least a portion of the slack 122 of the tether 114 remaining within the ventricle 106, while still leaving a sufficient length of the tether 118 within the ventricle 106 to allow access to the anchor 114 from a subannular position relative to the anchor 114 during delivery of the prosthetic valve. As shown, this allows the tether 118 to unwind from a constrained / coiled configuration to an inverted configuration, with the tether 118 reversing direction and the subannular portion of the tether 118 assuming a U-shaped bend. In FIG. 2H, the outer sheath 108 is retracted proximally, leaving the tether 118 in an inverted position within the left ventricle 106 for subsequent coaxial delivery of the prosthetic valve thereon.

[0033]

[0048] 2A-2H are shown as a series of operations, it should be understood that one or more of these operations may be performed in a different order. For example, several different combinations of advancing / retracting the outer sheath 108 toward / away from the anchor 114 and advancing / retracting the tether 118 relative to the outer sheath 108 may be used to position the tether 118 in an inverted configuration within the ventricle 106.

[0034]

[0049] 3A-3J illustrate one embodiment of valve delivery after anchors have already been placed by an anchor delivery device or system (e.g., as shown in FIG. 2H). A tether 118 can be attached to the anchor 114, which at least partially surrounds the chordae and / or leaflets of the native valve. The tether 118 can function as a guidewire for the valve delivery device.

[0035]

[0050] As described above, in some embodiments, the anchor delivery catheter can be used to position the tether 118 from a first configuration (e.g., as shown in FIG. 2F ) to a second configuration (e.g., as shown in FIG. 2G ) before and / or during delivery of the prosthetic valve. In some embodiments, the tether 118 in the second configuration includes at least one bend that inverts or nearly reverses the orientation of the tether 118 (i.e., the tether 118 can include a U-bend). In some embodiments, the U-bend or inversion of the tether 118 can occur near or adjacent to the apex of the heart (e.g., 120 in FIG. 3A ). In some embodiments, the inverted configuration of the tether 118 can be such that the central axial portion of the tether 118 is centered relative to the native annulus 145, the valve leaflets, and / or the chordae tendineae, while the distal end of the tether remains attached to the anchor 114. In some embodiments, In some embodiments, one or more bends in tether 118 enable tether 118 to remain coupled to the anchor (121 in FIG. 3A ) while the distal tip of valve delivery catheter 302 extends into second chamber 106, providing a (e.g., substantially) coaxial tracking path for aligning the waist portion of the prosthetic valve with native annulus 145. In some embodiments, the second configuration (i.e., inverted configuration) of tether 118 can be configured such that valve delivery catheter 302 can be caused to follow (e.g., coaxially) along tether 118 from first chamber 104, through the annulus, and into second chamber 106. In other embodiments, one or more bends in tether 118 enable tether 118 to remain coupled to anchor 114 when the proximal end of anchor 114 is facing into the ventricle.

[0036]

[0051] As shown in FIG. 3A , tether 118 can have a sufficient length so that a proximal portion is external to the patient, a central portion is routed through the patient's vasculature, and a distal portion is attached to anchor 114. Furthermore, the central portion can extend through a transseptal puncture into a first chamber of the heart (e.g., an atrium), across a heart valve (e.g., the mitral valve), and then loop or invert (i.e., retrograde) into a U-shaped bend within a second chamber of the heart (e.g., a ventricle). In some embodiments, as shown in FIG. 3A , tether 118 can be advanced to bend in both first chamber 104 (e.g., bend 119) and second chamber 106 (e.g., bends 120, 121) of the heart. In some embodiments, at least two bends of tether 118 include different bend angles. In some embodiments, at least two bends of tether 118 have different radii of curvature. In some embodiments, at least two bends of tether 118 include substantially the same bend angle. In some embodiments, at least two bends in tether 118 have substantially the same radius of curvature. In some embodiments, one or more tether bends occur in the subannular space (e.g., within the left ventricle). In some embodiments, one or more bends in tether 118 contact a portion of the interior wall of first chamber 104 and / or second chamber 106. Contact of the portion of tether 118 with the wall of the heart chamber can facilitate the formation of one or more bends in tether 118. Contact with the portion of the interior wall can be for a selected (e.g., predetermined) time period controlled by the operator of the valve delivery catheter.

[0037]

[0052] In some embodiments, tether 118 can be maintained in a substantially tension-free state (before and / or while being followed over valve delivery catheter 302). Tether 118 may be formed to be sufficiently resistant to kinking so that it can be advanced through or along a patient's anatomy and / or valve delivery catheter 302 when pushed (e.g., for delivery thereof or to be followed over valve delivery catheter 302). In some embodiments, tether 118 is sufficiently flexible so that it can assume a bend (e.g., one or more bends as described herein) when pushed.

[0038]

[0053] As shown in FIG. 3B , the valve delivery catheter 302 can be tracked over the tether 118 through a transseptal puncture into the first chamber 104 of the heart. In one embodiment, the valve delivery catheter 302 can be a coaxial delivery catheter. In this embodiment, the valve delivery catheter 302 can have a coaxial port 304 for tracking over the tether 118 (i.e., the port 304 can include a center point or axis that is coaxial with the central axis of the valve delivery catheter 302). The port 304 can be located in a nosecone, which is a conical portion at the distal end of the valve delivery catheter 302. The valve delivery catheter 302 can have an inner hollow shaft ("inner shaft") that forms a lumen shaped and sized to receive the tether 118 (see, e.g., 520 in FIG. 5A ). The inner shaft that forms the lumen of the valve delivery catheter 302 can be approximately centrally located, for example, along the central axis of the valve delivery catheter 302. The prosthetic valve 510 is compressible within the space between the inner shaft and outer sheath of the valve delivery catheter 302. Thus, the inner shaft of the valve delivery catheter 302 can extend through the central opening of the prosthetic valve 510. The port 304 is connectable to the inner shaft that forms the lumen of the valve delivery catheter 302. The port 304 can be located at the distal end (e.g., tip) of the valve delivery catheter 302. In some embodiments, the tether 118 is placed in the port 304 while the valve delivery catheter 302 is external to the patient, and the valve delivery catheter 302 is then tracked over the tether 118. The tether 118 can extend from the transseptal puncture through the first chamber 104 of the heart (e.g., the left atrium), through the valve annulus (e.g., the mitral valve), and to the second chamber 106 of the heart (e.g., the left ventricle).

[0039]

[0054] 3C shows an exemplary coaxial valve delivery catheter 302 in which a valve delivery member 308 (e.g., a valve capsule) carrying the prosthetic valve is tracked over the tether 118 until it is positioned beyond the native valve annulus 145. In some embodiments, the prosthetic valve is held directly within the valve delivery catheter 302 without the use of the valve delivery member 308. For example, the prosthetic valve 302 can be fitted into the valve delivery catheter 302 at a distal portion of the valve delivery catheter 302 in a collapsed state. In some embodiments, the prosthetic valve is coupled to a nosecone of the valve delivery catheter 302 and deployed by separation of the nosecone and distal end of the valve delivery catheter. In some embodiments, the prosthetic valve is deployed by use of a pusher catheter to move the prosthetic valve distally beyond the distal end of the valve delivery catheter 302. With the valve delivery member 308 (or the distal end of the delivery catheter 302) positioned beyond the native valve annulus, a majority (e.g., all) of the tether 118, which may extend from the port 304 of the valve delivery catheter 302 to the anchor 114, is within the second chamber 106 (e.g., the left ventricle). In some embodiments, the anchor 114 remains at or near the first spaced apart position 130 while the valve delivery catheter 302 is tracked on the tether 118 beyond the native valve annulus.

[0040]

[0055] In some embodiments, while the valve delivery catheter 302 is tracked on the tether 118, the anchor 114 can be positioned at a first position 130 that is spaced apart from the valve annulus. In the first position 130, the anchor 114 can be moved sufficiently away from the annulus to minimize interference between the anchor 114 and the movement of the native valve leaflets and / or chordae tendineae. The first position 130 of the anchor 114 relative to the annulus can reduce the occurrence of paravalvular leak (PVL) due to, for example, interference between the anchor and the native valve leaflets and / or chordae tendineae prior to deployment of the prosthetic valve. In some embodiments, the anchor 114 at the first position 130 is spaced apart from the native valve annulus by about 10 millimeters (mm) to about 40 mm in the apical direction.

[0041]

[0056] Sometimes, after tracking the valve delivery device over the tether (e.g., before or during deployment of the prosthetic valve), it may be advantageous to move the anchor 114 from a first (distant) position to a second position closer to or near the native annulus 145. Positioning the anchor 114 in a closer position (e.g., adjacent to or abutting the native annulus 145) can facilitate sealing of the prosthetic valve frame and anchor 114 around the mitral valve leaflet body and / or chordae tendineae. This sealing can substantially reduce or prevent PVL of the deployed prosthetic valve. In some embodiments, the anchor 114 can be moved from the first distant position 130 to the second, closer position 140 using a (e.g., tensioned) tether and / or a (e.g., stiffened) positioning tool, as further described herein. In some embodiments, the second position 140 can be from about 3 mm to less than about 0.5 mm. In some embodiments, the second position 140 can be in contact with at least a portion of the native annulus 145. Movement of the anchor 114 may result in a change in the height of the anchor relative to the cardiac anatomy (e.g., upward and / or downward) and / or a change in the anchor angle (i.e., the angle extending between a plane substantially containing the anchor and the plane of the native valve (e.g., the annulus)).

[0042]

[0057] In some embodiments, a positioning tool can be used to adjust the position of anchor 114 after tether 78 is reversed. 1 shows an example of a positioning tool 306 being tracked distally along the everted tether 118 after the anchor 114 has been positioned across the native valve annulus. In some embodiments, the positioning tool 306 can be or include a hollow elongate body and can have sufficient lubricity and a shape and size to fit and track over the tether 118 within the lumen of the valve delivery catheter 302 and / or valve delivery member 308. The positioning tool 306 can be flexible enough to track over the tether 118 and assume the curvature of the tether 118. The positioning tool 306 can be configured to bend and rotate as it tracks the tether 118. The positioning tool 306 can follow the variable curvature that the tether 118 may assume within the left ventricle 106. The flexibility of the positioning tool 306 as it tracks can reduce the likelihood that it will interact with and / or load the tether 118, causing it to rotate or unencircle the anchor 114. A proximal portion of the positioning tool 306 can extend outside the patient and can fit into a control of the valve delivery catheter 302, which allows for manipulation of the valve delivery catheter 302. The control can include, for example, one or more actuators (e.g., buttons, knobs, rotatable members, and / or switches) on a handle at the proximal end of the valve delivery catheter 302. Manipulation of the positioning tool 306 can include translation, rotation, and / or compression. The positioning tool 306 is passed distally over the tether 118 until the distal end of the positioning tool 306 interfaces with (e.g., interfaces with) the distal portion of the tether 118 and / or the proximal end of the anchor 114. Optionally, the distal end of positioning tool 306 may be coupled (e.g., connected) to an attachment that removably attaches the proximal end of anchor 114 to the distal end of tether 118. The positioning tool may be formed from any material or combination of materials such as those used to form tethers.

[0043]

[0058] Axial compression of the positioning tool 306 can be used to stiffen the positioning tool 306 and / or to induce a predetermined curvature and / or bend in selected portions of the positioning tool (e.g., the enclosed tether). See, e.g., FIGS. 4A-4C. The selected portions can be preferentially bendable regions (e.g., see, e.g., FIGS. 4A-4C). In some embodiments, stiffening the positioning tool 306 urges the tether 118 to assume a predetermined shape and / or configuration. The bending / compression / stiffening of the positioning tool 306 can be actuated, for example, by pushing the positioning tool 306 relative to the tether 118 and / or by pulling the tether 118 relative to the positioning tool 306. In some embodiments, this compression force can be controlled by one or more actuators on the valve delivery catheter 302. In some cases, actuation of the positioning tool 306 can be controlled by a handle / system separate from the valve delivery catheter 302. The one or more actuators may be configured to provide a controlled degree of tension to the positioning tool 306. In some cases, the one or more actuators may be configured to lock the positioning tool 306 in a stiffened, bent configuration.

[0044]

[0059] 3E shows an example of a positioning tool 306 that has been tracked over tether 118 until its distal end couples with the distal end of tether 118 at coupling region 128. Positioning tool 306 has been inverted and compressed / rigidified into a predetermined shape. Thus, positioning tool 306 exhibits one or more predetermined bends at 150 (e.g., a U-shaped bend toward the apex of the heart) and 151 (adjacent to the attachment to anchor 114). The rigidified positioning tool 306 can also be used to apply tension to tether 118 (e.g., via interaction between tether 118 and positioning tool 306 at the coupling region) to enable precise control of the movement of anchor 114.

[0045]

[0060] In FIG. 3F, anchor 114 is moved from a first position (e.g., 130 in FIG. 3A) to the native annulus. 3F and 3G illustrate an example of the use of a stiffened (e.g., compressed) positioning tool 306 to move the anchor 114 toward a second position (e.g., 140 in FIG. 3G ) closer to the valve annulus. Alternatively, or in addition, tension can be applied to the tether 118 to move the anchor 114. In one embodiment, the stiffened and inverted positioning tool 306 can be used to achieve axial alignment of the anchor 114 with the valve delivery catheter 302. Alignment can include aligning the anchor 114 so that it is positioned in a plane perpendicular to the plane of the distal end of the valve delivery catheter 302. The stiffened and inverted positioning tool 306 can also be used to move the anchor 114 upward (proximally) toward the valve annulus, as shown in FIGS. 3F and 3G , to better engage the valve leaflets and reduce leakage around the valve / anchor (paravalvular leakage). In some embodiments, the stiffened and inverted positioning tool 306 allows the anchors 114 to achieve planarity with the valve annulus 145, thereby helping to ensure planar positioning of the valve frame relative to the mitral annulus. The positioning tool 306 can also ensure that the anchors 114 maintain good encirclement of the native anatomy (e.g., the chordae tendineae and apex).

[0046]

[0061] 3G shows an example of anchor 114 in (second) position 140 near the native valve annulus in preparation for deployment of the prosthetic valve from valve delivery member 308 of valve delivery catheter 302. In some embodiments, the positioning of anchor 114 may be assessed prior to and / or during deployment of the prosthetic valve. Positioning tool 306 and / or tether 118 can be used to make selected adjustments to the position of anchor 114 as deemed necessary by the clinician.

[0047]

[0062] FIG. 3H illustrates an example of a first portion of deployment of a prosthetic valve from the valve delivery member 308 of the coaxial valve delivery catheter 302. The first portion of deployment can be a partial deployment of the prosthetic valve. In the example illustrated in FIG. 3H, the outer sheath of the valve delivery catheter 302 is retracted proximally to expose a distal portion of the valve delivery member 308 carrying the prosthetic valve 310. In some embodiments, the prosthetic valve 310 self-deploys. Retraction of the retaining outer sheath can expand the prosthetic valve 310 to contact the native valve leaflets and / or chordae tendineae surrounded by the anchors 114. In some embodiments, the first portion of the prosthetic valve 310 deployed includes a portion of the prosthetic valve 310 within the subannular space or the second heart chamber 106. In some embodiments, the first portion of the prosthetic valve 310 deployed includes a portion of the prosthetic valve 310 within the supranuclear space or the first heart chamber 104.

[0048]

[0063] FIG. 3I illustrates an example of sequential deployment of a second portion of the prosthetic valve 310 from the valve delivery member 308. Continued deployment of the prosthetic valve 310 can include further proximal retraction of the valve delivery member catheter 302. Continued deployment of the prosthetic valve 310 can include expansion of the remaining portion of the prosthetic valve 310. In some embodiments, the second portion includes the remaining portion of the prosthetic valve 310 that was not deployed during deployment of the first portion. In some embodiments, the second portion of the prosthetic valve 310 deployed includes the portion of the prosthetic valve 310 that is in the supranuclear space or the first heart chamber 104. In some embodiments, the second portion of the prosthetic valve deployed includes the portion of the prosthetic valve that is in the subannular space or the second heart chamber 106. The valve 310 can be held in place using a compression fit between the valve 310 and the anchor 114. As shown in FIG. 3H, the valve 310 can include one or more flares, such as a ventricular flare and an atrial flare. The prosthetic valve may include a waist that forms a central portion of the valve 310. The valve 310 may be seated against the anchors 114 such that the anchors surround the waist portion of the valve 310.

[0049]

[0064] Although the above describes deployment of the prosthetic valve 310 by proximal retraction of the coaxial valve delivery catheter 302, it should be understood that alternative modes of deployment of the prosthetic valve 310 are possible. For example, in some embodiments, the valve delivery member 308 is extended from its (e.g., initial) position distally beyond the mitral valve to at least partially expose a first portion of the prosthetic valve 310. In some embodiments, the first portion is a distal portion of the prosthetic valve 310 and the second portion is a proximal portion. In some embodiments, the first portion is a proximal portion of the prosthetic valve 310 and the second portion is a distal portion. Alternatively, or in addition, the valve delivery catheter 302 can be retracted proximally to at least partially expose a second portion of the prosthetic valve. In some embodiments, the first portion is a proximal portion of the prosthetic valve and the second portion is a distal portion.

[0050]

[0065] Additionally, while the above describes deployment of the valve from a coaxial delivery catheter, it should be understood that alternative manners of deployment of the prosthetic valve 310 with an inverted tether and / or positioning tool are possible. For example, the valve delivery catheter can include a monorail lumen for the tether. An example of a valve delivery system that can be used with an inverted tether and / or positioning tool as described herein is described in PCT Application No. PCT / US2021 / 026463, entitled "VALVE DELIVERY SYSTEM," filed April 8, 2021, which is incorporated herein by reference in its entirety.

[0051]

[0066] In some embodiments, the inverted positioning tool 306 and / or tether 118 may be used to adjust the position of the anchor 114 before, during, and / or after deployment of some or all of the prosthetic valve 310. Position adjustments may be made in response to clinician assessment of the native valve leaflets, chordae tendineae, hemodynamics, and / or prosthetic valve performance. Once the prosthetic valve 310 is fully deployed and positioned, the positioning tool 306 may be retracted, and the tether 118 may be released and withdrawn from the anchor 114. In some embodiments, the tether 118 may be separated from the anchor by a release coupling. Examples of releasable couplings are described in U.S. Patent Application No. 16 / 824,576, which is incorporated herein by reference in its entirety. The valve delivery catheter 302 and valve delivery member 308 may be similarly withdrawn and removed. FIG. 3J shows valve delivery catheter 302 including valve member 308 being withdrawn and removed from the body, leaving anchor 114 and prosthetic valve 310 in place.

[0052]

[0067] 4A-4C illustrate an example of a manner of interaction between the proximal end of the anchor, the distal portion of the tether, and the distal end of the positioning tool (e.g., during deployment of the anchor and tether as described in connection with FIGS. 3A-3J). FIGS. 4A and 4B show perspective and side cross-sectional views, respectively, of the proximal end of anchor 402, the distal portion of tether 404, and the distal end of positioning tool 406. As shown in FIG. 4A, the proximal end of anchor 402 is attached to tether 404 at a releasable attachment 408. The attachment may include an adhesive bond, a solder bond, a crimp, or a fastener. In some embodiments, tether 404 and anchor 402 are attached prior to delivery of anchor 402. In some embodiments, the attachment includes at least one end having a selected geometry sized and shaped to interact with positioning tool 406. 4A-4C, the attachment 408 generally comprises a wedge-shaped portion having an angled or beveled proximal end 410 shaped to interact or mate (i.e., interlock) with an angled or beveled distal end 412 of the positioning tool 406. As the positioning tool 406 is advanced distally along the tether 404, the positioning tool 404 eventually abuts the wedge-shaped portion 408 of the tether 404. The interaction of the wedge-shaped portion 408 with the positioning tool 406 can create an aligned, torsionally rigid interaction between the tether 404 (and attached anchor 402) and the positioning tool 406. It should be understood that other shapes for the distal portion 410 of the tether and the distal end 412 of the positioning tool are possible, so long as the ends are shaped to interact with each other in a torsionally rigid manner. For example, the distal end 412 of the positioning tool 406 can be a straight cut edge (eg, perpendicular to the axis of the positioning tool 406 when in a straight configuration).

[0053]

[0068] The positioning tool 406 may include spaces, gaps, or notches (e.g., 414) along one or more distal portions. Under axial compression, the notches facilitate selective deflection of the positioning tool in a selected (e.g., predetermined) direction and / or angle. FIG. 4C shows an example of compression of the positioning tool 406, where the distal end of the positioning tool 406 has been advanced to couple to the attachment 408, with the notches 416 exhibiting a narrowed gap under compression. Compression of the positioning tool 406 can induce curvature (e.g., bending or bending) in one or more portions. The amount of curvature may depend on the geometry of the notches and / or the amount of compression applied to the positioning tool. The interaction or engagement is such that relative rotation between the tether 404 and the positioning tool 406 is substantially prevented. Rotation of the distal end of the positioning tool 406 when coupled with the attachment on the tether 404 causes rotation at the distal end of the tether 404, which in turn causes rotation of the anchor 402. Rotation of the anchor 402 can be used to adjust the angle at which the anchor 402 is positioned relative to the chordae tendineae, the apex, and / or the annulus. The positioning tool and tether are further described in PCT / US2021 / 026463, filed April 8, 2021, and entitled "VALVE DELIVERY SYSTEM," which is incorporated herein by reference in its entirety.

[0054]

[0069] In some embodiments, the inverted and rigidized positioning tool may have multiple curves or bends formed along different circumferential sides or faces of the positioning tool. FIG. 5A shows a perspective view of an example distal portion of a valve delivery catheter 502 carrying a valve delivery member 508, with the positioning tool 506 extending through a lumen formed by an inner shaft and / or sheath within the distal portion. FIG. 5B shows a different perspective view of a portion of a prosthetic valve 510 carried by the valve delivery member 508 exposed by proximal retraction of the valve delivery catheter 502. For clarity, the tether on which the positioning tool follows and the anchor for the prosthetic valve to which the tether is attached have been omitted from the drawing. The example positioning tool in FIGS. 5A and 5B has a first bend 514 in the YZ plane and a second bend 512 in the XY plane when the positioning tool is in a compressed / rigidized state. In some embodiments, the compressed positioning tool includes a bend of about 5° to about 310°. The bends of the positioning tool 506 can be coupled to the anchors and aligned with and / or biased to the tether to maintain a configuration (e.g., bend) of the tether that enables positioning of the valve delivery catheter 502 and deployment of the prosthetic valve 510. In some embodiments, the compressed positioning tool 506 includes a bend of about 70° to about 100°, e.g., about 90°, as shown at bend 512 in FIG. 5A. In some embodiments, the positioning tool 506 includes a bend of about 150° to about 310°, e.g., about 180°, as shown at bend 514 in FIG. 5A. In some embodiments, the bend includes a radius of curvature of about 2 millimeters (mm) to about 20 mm. In some embodiments, the positioning tool 506 has a substantially straight portion between the first bend and the second bend (e.g., FIG. 5A). The substantially straight portion can have a length of about 10 mm to about 35 mm.

[0055]

[0070] 6A-6D illustrate a portion of a positioning tool 606 having a configuration of preferentially bendable regions intended to allow for inversion of the positioning tool 606. The positioning tool 606 is shown with a polar coordinate system having a longitudinal axis L, a radial axis R, and an azimuthal (e.g., angular) axis φ. The preferentially bendable regions also enable the positioning tool 606, in use, to (1) assume a rigidified configuration capable of positioning an anchor in the heart, and (2) create a curve (bend) that provides space for positioning a valve delivery catheter and deploying a prosthetic valve. The positioning tool 606 includes an elongate body having an annular wall of a generally constant cross-section (e.g., cross-section B-B 608 in FIG. 6C ) that allows for translation and rotation within the valve delivery catheter. In some embodiments, the preferentially bendable regions include one or more notches that at least partially circumscribe the outer wall of the positioning tool 606. In some embodiments, the notches have a generally constant width (e.g., 616 in FIG. 6A ). In some embodiments, In some embodiments, the cutouts have varying widths (e.g., 626 in FIG. 6A ). In some embodiments, the spacing between adjacent cutouts in a bendable region is generally constant (e.g., 618 in FIG. 6A ). In some embodiments, the spacing between adjacent cutouts in a bendable region is variable (e.g., 628 in FIG. 6A ). In some embodiments, a first bendable region (e.g., 614 in FIG. 6A ) is spaced apart from a second bendable region (e.g., 624 in FIG. 6A ) along the longitudinal axis of the positioning tool. In some embodiments, a first bendable region (e.g., cross section A-A 610 in FIG. 6B ) is spaced apart from a second bendable region (e.g., cross section C-C 612 in FIG. 6D ) along the azimuthal axis of positioning tool 606. It should be understood that the various shapes, sizes, and arrangements of cutouts shown in FIG. 6A are illustrative only and need not be all-inclusive (e.g., a positioning tool may include only some of the variations shown in positioning tool 606). Additionally, while notches are described above as forming preferentially flexible regions, those skilled in the art will recognize that several techniques can be used to form preferentially flexible regions in the positioning tool. For example, a knit pattern reinforcing the outer wall of the positioning tool may include regions of reduced reinforcement. For example, the positioning tool may include a variable durometer polymer material or one or more mechanical hinges.

[0056]

[0071] In any of the embodiments described herein, the positioning tool 306 can be configured to loop and follow over the inverted tether 118 without unencircling the anchor 114. The positioning tool 306 may be configured to lift the anchor 114 axially within the subannular space closer to the plane of the native valve. The positioning tool 306 may be configured to support the anchor 114 in place without affecting the deployment of the prosthetic valve 310. The positioning tool 306 may be configured to force the valve delivery catheter 302 to follow (e.g., coaxially) through the anchor 114.

[0057]

[0072] 10A shows an exemplary positioning tool 1006 positioned over an inverted tether and engaged with an anchor 1014. The positioning tool 1006 can include a first preferentially bendable region 1044 and a second preferentially bendable region 1046. The first preferentially bendable region 1044 can be configured to bend along a first plane (e.g., the YZ plane), and the second preferentially bendable region 1046 can be configured to bend along a second plane (e.g., the XY plane) that is different from the first plane. In some embodiments, the second plane is perpendicular to the first plane. In some embodiments, the second plane is non-perpendicular to the first plane. The first preferentially bendable region 1044 can be configured to exhibit a U-shaped bend (e.g., toward the apex of the heart). The second preferentially bendable region 1046 can be located closer to the distal end 1050 of the positioning tool 1006 than the first preferentially bendable region 1044 and can be configured to bend radially inward toward the center of the anchor 1014. Each of the first preferentially bendable region 1044 and the second preferentially bendable region 1046 can include a space or gap (e.g., a notch) that allows them to preferentially bend from a straight configuration to a predetermined shape when a compressive force is applied to the positioning tool 1006 (e.g., as described above in connection with FIGS. 4A-4C ). For example, one side of the first preferentially bendable region 1044 can include a notch configured to form a U-shape when driven into a rigidified state. This shape can allow the positioning tool 1006 to support and / or push the anchor closer toward the native annulus. One side of the second preferential bendable region 1046 may include a notch configured to bend the positioning tool 1006 radially inward by a predetermined angle.

[0058]

[0073] The positioning tool 1006 can have a first section 1030 and a second section 1040. The first section 1030 is between an anchor surface 1032 and a surface 1034 where the curvature of a first preferentially bendable region 1044 begins. The second section 1040 is between the surface 1034 and where the curvature of a second preferentially bendable region 1046 begins. The second section 1040 can be The first section 1030 may be generally parallel to the first section 1030. The axial length L1 of the first section 1030 may be selected to hold the anchor 1014 at a height sufficient for axial alignment with the valve delivery catheter (and prosthetic valve) during deployment of the prosthetic valve and to provide space for deployment of the prosthetic valve. In some embodiments, the length L1 ranges between any two of 15 mm, 20 mm, 25 mm, 30 mm, and 40 mm.

[0059]

[0074] FIG. 10B shows a close-up view of the distal portion of the positioning tool 1006. As shown, the distal end 1050 can include a beveled edge that can be shaped to interact with or mate with a corresponding beveled edge on a portion of the tether and / or anchor (e.g., attachment 408). FIG. 10B also shows a circumferential notch 1054 on one side of the second selectably bendable region 1046 to enable bending into a predetermined shape (e.g., an arc-shaped second preferentially bendable region 1046 as shown in FIG. 10A) upon application of an axial compressive force to the positioning tool 1006. For example, the second preferentially bendable region 1046 can be configured to bend toward the notch 1054 such that the gap defined by the notch 1054 narrows. Although not shown in FIG. 10B, the first preferentially bendable region 1044 can also include a circumferential notch that forms the predetermined U-shape shown in FIG. 10A.

[0060]

[0075] 10B , the second section 1040 of the positioning tool 1006 may also include notches 1066. The pattern of the notches 1066 can be configured to allow the second section 1040 to bend / flex laterally as it follows on the tether, but to allow the second section 1040 to remain straight when an axial compressive force is applied to the positioning tool 1006. In some embodiments, the notches 1066 are arranged in a spiral pattern around the circumference of the positioning tool 1006. In some cases, the first section 1030 includes notches the same as or similar to the notches 1066 to allow the first section 1030 to remain straight when an axial compressive force is applied to the positioning tool 1006, but to allow the first section 1030 to bend / flex as it follows on the tether.

[0061]

[0076] 11A and 11B show another exemplary positioning tool 1106 having similar features to the positioning tool 1006, but with some different features. The length L2 of the first section 1130 between the anchor surface 1132 and the surface 1134 where the curvature of the first preferentially bendable region 1144 begins is longer than the length L1 of the first section 1030 of the positioning tool 1006 of FIGS. 10A and 10B. This longer length can help ensure that the anchor 1114 is held at a height sufficient to provide space for prosthetic valve deployment. In some embodiments, the length L2 ranges between any two of 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, and 50 mm.

[0062]

[0077] 10A and 10B, the second section 1140 can be non-parallel to the first section 1130. This angled configuration can provide more space for deployment of the prosthetic valve (e.g., a frame portion of the prosthetic valve). For example, this configuration can position the distal end 1150 and the second preferentially bendable region 1146 farther from the first section 1130, thereby reducing the likelihood that the distal end 1150 and / or the second preferentially bendable region 1146 will interfere with the prosthetic valve during deployment, causing the prosthetic valve to become displaced.

[0063]

[0078] 11B, the distal end 1150 of the positioning tool 1106 can have a straight (e.g., non-beveled) edge. This straight configuration can prevent the distal end from cutting into the tether. Additionally, the distal section 1159 of the positioning tool 1106 can include a distal section 1159 that is distal to the second preferentially bendable region 1146. The distal section 1159 can provide more room for deployment of the prosthetic valve. 9 may include notches 1166 configured to allow the distal segment 1159 to bend / flex when tracked on the tether, but to allow the distal segment 1159 to remain straight when a compressive force is applied to the positioning tool 1106. In some embodiments, the notches 1166 are arranged in a spiral pattern around the circumference of the positioning tool 1106. In some cases, the first segment 1130 and / or the second segment 1140 also include notches the same as or similar to the notches 1166 that allow the first segment 1130 and / or the second segment 1140 to bend / flex while tracked on the tether, but to allow the first segment 1130 and / or the second segment 1140 to remain straight when an axial compressive force is applied to the positioning tool 1106.

[0064]

[0079] 7A-7D show perspective and cross-sectional views of an example prosthetic valve carried within a valve delivery catheter for delivery coaxially along a tether. In this example coaxial valve delivery catheter 700 (shown in FIG. 7A), the prosthetic valve is carried by a valve delivery member 708 at the distal end of the valve delivery catheter 700. FIG. 7C shows the valve delivery catheter 700 and the outer wall 702 (also referred to herein as an outer sheath) of the valve delivery member 708 positioned within the valve delivery catheter, maintaining the prosthetic valve around a central lumen 720. The central lumen is formed by the inner shaft of the valve delivery member, which extends from the distal end (e.g., the nosecone portion) to the proximal end and is sized to accommodate a positioning tool 706 and a tether 718 for translation therein. The example prosthetic valve has a frame 710 and leaflets 712 supported thereby and packed around the central lumen 720.

[0065]

[0080] The exemplary coaxial valve delivery catheter 705 of FIG. 7B is similar to the catheter 700 of FIG. 7A , except that in this embodiment, there is no valve delivery member. In this exemplary valve delivery catheter 705, the prosthetic valve is held by a nosecone at the distal end of the valve delivery catheter. FIG. 7D shows the outer wall 752 (also referred to herein as an outer sheath) of the valve delivery catheter and the inner shaft 770, which defines a distal portion of a tether lumen. The tether lumen extends from the distal end of the valve delivery catheter to the proximal end (e.g., external to the patient) and is sized to accommodate a positioning tool 756 and a tether 768 therein for translation therethrough. The exemplary prosthetic valve has a frame 760 and leaflet material 762 supported thereby and packed around a central lumen. A nosecone is coupled to the distal end of the valve delivery catheter. In some embodiments, the valve delivery member includes a nosecone. The nosecone can include a port sized to receive the tether and positioning tool. The port can be centered relative to the outer periphery (e.g., outer periphery) of the nosecone. When coupled, the port and tether lumen are adjacent to each other and aligned with each other.

[0066]

[0081] 8 is a flowchart 800 illustrating a method for following a valve delivery catheter over a tether to deploy a prosthetic valve. An example operation 802 includes following a delivery device over a tether into a first chamber of the heart, the tether being coupled to an anchor near the native annulus of the heart. An example operation 804 includes following a delivery device over the tether into a second chamber of the heart to position a prosthetic valve capsule carried by the delivery device beyond the native annulus. An example operation 806 includes exposing the prosthetic valve for deployment within the native annulus.

[0067]

[0082] 9 is a flowchart 900 illustrating a method for coaxially following a valve delivery catheter over a tether to deploy a prosthetic valve. An example operation 902 includes moving a portion of the tether into a chamber (e.g., a ventricle) of a patient via an anchor to which the tether is attached. An example operation 904 includes deploying a positioning tool along the tether toward the anchor, or an attachment attached to the proximal end of the tether and / or anchor. The distal edge of the positioning tool then contacts the proximal edge of the anchor, or the tether and / or attachment. or the proximal edge of an attachment attached to the proximal end of the anchor. An exemplary operation 906 includes stiffening the positioning tool and / or tensioning the tether. In some cases, the positioning tool assumes a curved shape when compressed / rigidified. For example, the positioning tool may assume a U-shaped bend under the annulus relative to the anchor such that the distal end of the positioning tool is oriented toward the anchor. The distal end of the positioning tool may include an engagement surface configured to directly or indirectly engage or couple with the proximal end of the anchor. In this manner, the stiffened positioning tool can engage with the anchor to control its movement. In some cases, the positioning tool includes a second bend near the distal end of the positioning tool that bends radially inward to accommodate the anchor's geometry.

[0068]

[0083] Example operation 908 includes adjusting the position of the anchor relative to the patient's native anatomy to a selected position using a positioning tool and / or tether. For example, it may be desirable for the anchor to be as close to the annulus of the native valve as possible. In some cases, the anchor may be adjusted upward toward the annulus of the native valve. Example operation 910 includes causing the valve capsule to follow the tether coaxially through the patient's anatomy and past the plane of the native valve. Example operation 912 includes deploying the prosthetic valve from the valve capsule into the anchor. While the above is shown as a series of operations, it should be understood that one or more of the operations may be performed in a different order. For example, in some embodiments, stiffening the positioning tool and / or tensioning the tether occurs after following the valve delivery catheter past the native heart valve. For example, in some embodiments, deploying the positioning tool occurs after following the valve delivery catheter past the native heart valve.

[0069]

[0084] FIG. 12 is a flowchart 1200 illustrating a method for delivering a prosthetic valve, including reversing a tether to cause the prosthetic valve to track. An exemplary operation 1202 includes engaging an anchor with the chordae tendineae of a diseased native valve. The anchor deployment may be performed using an anchor delivery device or system, which may include an anchor delivery catheter (also referred to as a steerable catheter or outer sheath) that can be configured to flex and extend to steer the anchor to the proper position. In some cases, the anchor delivery device or system may further include an anchor guide that is translatable within the steerable catheter. The anchor guide may include an internal lumen for accommodating the anchor therein. The anchor guide can assume a curved shape upon deployment of the anchor from the anchor guide. In some examples, the anchor includes a wire that, upon deployment, wraps around a central axis and has a planar shape. The anchor is deployable such that the wraps encircle the chordae tendineae of the native valve. The proximal end of the anchor can be releasably attached to a tether that maintains connection to the anchor during subsequent deployment of the prosthetic valve.

[0070]

[0085] Once the anchor is deployed, in operation 1204, a portion of the tether can be translated through the native valve and positioned in an everted configuration. In some examples, this is done using a steerable catheter of the anchor delivery device or system. For example, while the steerable catheter is still tracking over the tether (e.g., after deployment of the anchor), the steerable catheter can be advanced through the valve annulus and the plane of the anchor. This advancement of the steerable catheter can translate a portion of the tether from a first chamber of the heart (e.g., the atrium) to a second chamber of the heart (e.g., the ventricle). In some cases, positioning the tether in the everted configuration includes causing the tether to assume a U-shaped bend. In some cases, positioning the tether in the everted configuration includes translating the tether distally relative to the steerable catheter to provide additional tether length within the second chamber.

[0071]

[0086] Once the tether is in the inverted configuration, the valve delivery device is attached to the tether in operation 1206. The prosthetic valve can be released from the valve delivery device into the native valve annulus and into the anchors. Counteracting forces between the prosthetic valve and the anchors can secure the prosthetic valve in place within the native valve annulus. Once the prosthetic valve is fully deployed, the valve delivery device and tether can be removed from the heart and the patient's body.

[0072]

[0087] The prosthetic valve may be similar to existing transcatheter-delivered valves. The prosthetic valve may be similar to existing surgical biological and mechanical valves. At least a portion of the valve section may be located within at least a portion of the prosthetic valve, for example, with a prosthetic valve framework. The valve section may include an apex formed of a multi-layer material for selective function. The valve section may include at least one apex having an inner layer and an outer layer. The valve section may be directly attached to the prosthetic valve. Alternatively, the valve section may be attached to an intermediate valve structure that is connected to the prosthetic valve. The valve section may be connected to the prosthetic valve before or after the prosthetic valve is deployed adjacent to the native valve. The prosthetic valve may be attached to the apex, e.g., the outer layer of the apex, of the valve section at one or more ends of the prosthetic valve. The prosthetic valve may be attached to the apex, e.g., the outer layer of the apex, of the valve section at one or more middle portions of the prosthetic valve. The valve section may include multiple apexes. The valve section may include a biocompatible one-way valve. Flow in one direction can deflect the apex open, while flow in the opposite direction can close it.

[0073]

[0088] The frame structure can be configured like a stent. The frame structure can include, for example, a diamond-patterned scaffold formed from a shape-memory material (e.g., Nitinol (NiTi)). Those skilled in the art will recognize that many other structures, materials, and configurations for the frame structure are possible. For example, the frame structure can be formed from a sufficiently elastic polymer. The frame structure can also be formed from a combination of metal and polymer, such as a metal (e.g., a shape-memory material) coated with a polymer. The frame structure can include various patterns in addition to a diamond shape. In some embodiments, the frame structure is a closed frame so that blood flow is forced into and through the valve compartments. One or more skirts and / or seals can help force blood through the valve compartments.

[0074]

[0089] Based on the description herein, one skilled in the art will recognize that any of the prosthetic valves described herein can include any of the frame structure shape, frame structure design, frame structure material, anchor shape, anchor coiling, anchor material, free tip, apical configuration, or any other feature of the variable features described herein, in any combination as desired.

[0075]

[0090] Example 1

[0091] 13A-13C show fluoroscopic images of an exemplary tether reversal procedure performed in a calf heart. FIG. 13A shows anchor 114 positioned around the chordae tendineae and attached to tether 118 coming from outer sheath 108 (e.g., as in FIG. 2B). FIG. 13B shows outer sheath 108 advanced toward the left valve leaflet. As shown, there is a portion of slack 122 of tether 118 above anchor 114, which may assume a constrained / kinked configuration due to tension (e.g., as in FIG. 2F). FIG. 13C shows the outer sheath 108 after being partially retracted within outer sheath 108 to remove slack 122 and allow tether 118 to unwind into a U-shaped configuration below the annulus relative to anchor 114 (e.g., as in FIG. 2G). The tether 118 is shown in an inverted configuration.

[0076]

[0092] Example 2

[0093] 14A-14C show fluoroscopic images of an exemplary positioning tool 1006 used to control the axial height of the anchor 114 within the heart. These images show the anchor positioned around the chordae tendineae and attached to a tether, with the positioning tool 1006 being advanced from the valve delivery catheter 302 over the tether. The positioning tool 1006 is shown in a rigid, bent state. FIG. 14A shows the positioning tool 1006 supporting the anchor 114 at a first axial height relative to the native annulus 145. In FIG. 14B, the positioning tool 1006 is pushed distally through the anchor 114, thereby moving the anchor 114 distally to a second axial height, further from the native annulus 145. In FIG. 14C, the positioning tool 1006 is pulled proximally in the rigid / bent configuration, thereby moving the anchor 114 proximally to a third axial height, closer to the native annulus 145. These images show how the positioning tool 1006 can be used to control the axial height of the anchor 114.

[0077]

[0094] Example 3

[0095] 15A and 15B show fluoroscopic images of an example deployment of a prosthetic valve 310 in a heart, illustrating problems that can arise related to the length of the positioning tool 1506. As discussed above, the length (e.g., L1 or L2) of the positioning tool 1506 must be long enough so as not to interfere with the deployment of the prosthetic valve 310. FIG. 15A shows the positioning tool 1506 supporting the anchor 114 near the valve annulus prior to deployment of the prosthetic valve 310 from the valve delivery catheter 302. FIG. 15B shows the prosthetic valve 310 being advanced for deployment into the anchor 114. However, the U-shaped end of the positioning tool 1506 is too close to the anchor 114 to provide sufficient space for deployment of the prosthetic valve 310. As discussed above, the length of the positioning tool 1506 can be selected to be long enough to provide sufficient space for prosthetic valve deployment.

[0078]

[0096] When a feature or element is referred to herein as being "on" another feature or element, it can be directly on the other feature or element, or intervening features and / or elements may also be present. Conversely, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. Also, when a feature or element is referred to as being "connected," "attached," or "coupled" to another feature or element, it should be understood that it can be directly connected, attached, or coupled to the other feature or element, or there may be intervening features or elements present. Conversely, when a feature or element is referred to as being "directly connected," "directly attached," or "directly coupled," there are no intervening features or elements present. Although described and illustrated with respect to one embodiment, features and elements so described or illustrated are applicable to other embodiments. Furthermore, when a structure or feature is referred to as being "adjacent" to another feature, those skilled in the art will recognize that it may have portions that overlap or underlie the adjacent feature.

[0079]

[0097] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms unless the context clearly indicates otherwise. Furthermore, when the terms "comprises" and / or "comprises" are used herein, they specify the presence of stated features, steps, operations, elements, and / or components, but may also include the presence or absence of one or more other features, steps, operations, elements, components, and / or groups thereof. It should be understood that "does not preclude" as used herein. The term "and / or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0080]

[0098] Spatially relative terms such as "below," "down," "bottom," "above," and "upper" may be used herein for ease of description to describe the relationship of one element or feature to another element or feature as illustrated in the figures. It should be understood that these spatially relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures were inverted, an element described as being "below" or "below" another element or feature would then be in an orientation "above" that other element or feature. Thus, the illustrative term "below" can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations), and the spatially relative descriptors used herein will be interpreted accordingly. Similarly, terms such as "upward," "downward," "vertical," "horizontal," and the like are used herein for descriptive purposes, unless specifically indicated otherwise.

[0081]

[0099] Although the terms "first" and "second" may be used herein to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms may be used to distinguish one feature / element from another. Thus, a first feature / element described below could also be referred to as a second feature / element, and similarly, a second feature / element described below could also be referred to as a first feature / element, without departing from the teachings of the present invention.

[0082]

[0100] Throughout this specification and the claims that follow, unless the context requires otherwise, the word "comprise" and variations such as "comprises" and "comprising" mean that various components may be employed together in methods and articles (e.g., compositions and apparatuses that include devices and methods). For example, the term "comprising" is understood to imply the inclusion of any listed elements or steps, but not the exclusion of other elements or steps.

[0083]

[0101] Unless expressly stated, all numerical values ​​used in this specification and claims, including those used in the examples, can be read as if preceded by the term "about" or "approximately," even if these terms are not explicitly stated. The phrase "about" or "approximately" may be used when describing a magnitude and / or location to indicate that the stated value and / or location is within a reasonable expected range of values ​​and / or locations. For example, a numerical value may have a value that is + / - 0.1% of the stated value (or range of values), + / - 1% of the stated value (or range of values), + / - 2% of the stated value (or range of values), + / - 5% of the stated value (or range of values), or + / - 10% of the stated value (or range of values). Any numerical value given herein should also be interpreted as including about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any range described herein is intended to include all subranges encompassed therein. It is also understood that where a value is disclosed, "less than or equal to" that value, "greater than or equal to" that value, and possible ranges between values, as would be appropriate to one of ordinary skill in the art, are also disclosed. For example, if a value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" (e.g., where X is a number) are also disclosed. Also, throughout this application, data are presented in several different formats, and these data may be presented with endpoints and starting points, and the ranges between these may be used interchangeably. It is also understood that a range represents a range of any combination of the data points. For example, if a specific data point of "10" and a specific data point of "15" are disclosed, it is understood that values ​​greater than 10 and 15, greater than or equal to 10 and 15, less than 10 and 15, less than or equal to 10 and 15, and values ​​equal to 10 and 15 are also considered disclosed, as are values ​​between 10 and 15. It is also understood that each unit amount between two specified unit amounts is disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0084]

[0102] Although various exemplary embodiments have been described above, any of many modifications may be made to the various embodiments without departing from the scope of the invention, as set forth in the claims. For example, the order in which the various method steps described are performed may often be changed in alternative embodiments, and one or more method steps may be skipped entirely in other alternative embodiments. Optional features of the various device and system embodiments may be included in some embodiments and not in others. Accordingly, the foregoing description has been presented primarily for purposes of illustration and should not be construed as limiting the scope of the invention, as set forth in the claims.

[0085]

[0103] The examples and illustrations contained herein are for purposes of illustration, not limitation, and indicate specific embodiments in which the present subject matter may be practiced. As noted above, other embodiments are available and may be derived in such a manner that structural and logical substitutions and changes may be made without departing from the scope of the present disclosure. Such embodiments of the present subject matter may be individually or collectively referred to herein under the term "invention" for convenience only, without intending to intentionally limit the scope of this application to any single invention or inventive concept if, in fact, multiple are disclosed. Thus, although specific embodiments are illustrated and described herein, any configuration intended to achieve the same purpose may be substituted for the specific embodiment shown. The present disclosure is intended to cover any modifications or variations of the various embodiments. Combinations of the above embodiments, as well as other embodiments not specifically described herein, will be apparent to those skilled in the art upon reviewing the above description. The present invention includes the following aspects. 1. A method of treating a diseased native valve in a patient, comprising: encircling the chordae of the diseased native valve with anchors having ties attached thereto; With the anchor positioned around the chordae tendineae, translating a portion of the string through the annulus of the diseased native valve from a first chamber of the heart to a second chamber of the heart, wherein the translation of the string causes the string to form a bend in the second chamber; causing a valve delivery device to follow the string; Releasing a prosthetic valve from the valve delivery device into the annulus of the diseased native valve and into the anchor. 2. The method according to claim 1, The method further includes delivering the anchor to the diseased native valve with an anchor delivery device including a steerable catheter. 3. The method of claim 2, wherein the step of translating the portion of the string through the annulus of the diseased native valve comprises: advancing the steerable catheter toward a surface of the anchor; advancing the string while maintaining the string attached to the anchor to create slack in the string that wraps at least partially within the first chamber; and advancing the steerable catheter past the face of the anchor to position at least a portion of the string within the second atrium. 4. The method described in 3., wherein the step of advancing the steerable catheter includes the step of advancing the steerable catheter to a position proximal to the apex of the second chamber. 5. The method described in 3., further comprising the step of retracting the anchor delivery device from the diseased native valve. 6. The method described in 2., wherein the anchor delivery device further includes an anchor guide configured to translate within the steerable catheter, the anchor guide including an internal lumen for accommodating the anchor. 7. The method of claim 6, wherein the anchor guide assumes a curved shape upon deployment of the anchor from the anchor guide. 8. The method of claim 1, wherein the string exhibits a substantially U-shaped bend within the second chamber when in a bent configuration. 9. The method of claim 8, wherein the step of positioning the string in the bent configuration includes translating the string distally relative to the steerable catheter to provide an extended string length within the second chamber. 10. The method described in 1., wherein the step of causing the valve delivery device to follow the string includes the step of advancing a valve delivery catheter through the annulus of the diseased native valve. 11. The method of claim 1, wherein the step of causing the valve delivery device to follow the string includes the step of deploying a positioning tool over the bent string. 12. The method of claim 11, further comprising the step of advancing the positioning tool distally until the distal end of the positioning tool engages with an attachment attached to the proximal end of the anchor. 13. The method of claim 11, further comprising the step of applying a compressive force along the positioning tool to stiffen the positioning tool. 14. The method of claim 13, wherein the step of applying a compressive force includes the step of pulling the string proximally to place tension on the string. 15. The method of claim 14, wherein the step of pulling the string proximally to tension the string includes using a handle to apply a controlled amount of tension to the string. 16. The method of claim 13, wherein the step of applying a compressive force causes the positioning tool to assume a generally U-shaped bend beneath the annulus of the anchor. 17. The method of claim 16, further comprising the step of releasably attaching a distal end of the positioning tool to the anchor. 18. The method according to claim 11, further comprising the step of adjusting the position of the anchor relative to the diseased native valve using the positioning tool. 19. The method of claim 18, wherein adjusting the position of the anchor includes pulling the positioning tool proximally to move the anchor toward the annulus of the diseased valve. 20. The method of claim 18, wherein the position of the anchor is adjusted to be closer to the annulus of the diseased native valve. 21. The method of claim 18, wherein the position of the anchor is adjusted so that the anchor is positioned in a plane perpendicular to the plane of the distal end of the valve delivery device. 22. The method of claim 1, wherein the step of bending the string within the second chamber includes the step of inverting the string within the second chamber. 23. The method of claim 1, further comprising the step of delivering the anchor to the diseased native valve by an anchor delivery system including a steerable catheter. 24. A delivery system for delivering a prosthetic valve to a diseased valve of the heart, comprising: a string configured to connect to a valve anchor and further configured to extend from a location external to the heart through at least a first chamber of the heart and into a second chamber of the heart; a valve delivery catheter configured to extend over the string into the second chamber, the valve delivery catheter configured to hold the prosthetic valve therein and release the prosthetic valve into the valve anchor with the string connected to the valve anchor; A delivery system comprising: 25. The delivery system of claim 24, wherein the string is configured to assume a substantially U-shape within the second chamber of the heart. 26. The delivery system of claim 24, wherein the string is releasably attached to the valve anchor. 27. The delivery system of claim 26, wherein the distal end of the string is configured to be releasably attached to the proximal end of the valve anchor. 28. The delivery system of claim 24, wherein the valve anchor has a helical shape and the valve delivery catheter is configured to extend through a central opening in the valve anchor to align the prosthetic valve prior to release of the prosthetic valve. 29. The delivery system of claim 28, wherein the valve delivery catheter is configured to axially align a central portion of the prosthetic valve with the diseased valve. 30. The system of claim 24, wherein the distal end of the valve delivery catheter includes a nosecone having a port sized and shaped to allow passage of the string, the port having a central axis coaxial with the central axis of the valve delivery catheter. 31. The delivery system of claim 24, further comprising a positioning tool configured to extend through the valve delivery catheter and over the string, the positioning tool configured to connect to the valve anchor and control the position of the valve anchor after it is deployed within the heart. 32. The delivery system of claim 31, wherein the positioning tool includes one or more regions configured to bend into a predetermined shape. 33. The delivery system of claim 32, wherein the region has a relatively reduced bending stiffness. 34. The delivery system of claim 32, wherein the one or more regions include one or more notches configured to allow the regions to bend into the predetermined shape when a compressive force is applied to the positioning tool. 35. The delivery system of claim 32, wherein the one or more regions are configured to bend to the predetermined shape when tension is applied to the string therein. 36. The delivery system of claim 32, wherein the first region is configured to transition from a linear shape to a U-shape. 37. The delivery system of claim 36, wherein the second region is configured to transition from a straight shape to a curved shape that bends radially inward toward the center of the valve anchor. 38. The delivery system of claim 32, wherein the positioning tool includes a distal edge configured to engage a proximal edge of the valve anchor or a proximal edge of an attachment attached to the proximal end of the valve anchor. 39. The delivery system of claim 38, wherein the distal edge of the positioning tool is beveled and configured to engage with a beveled edge of the proximal edge of the valve anchor that corresponds to the beveled distal edge, or with the proximal edge of an attachment attached to the proximal end of the valve anchor. 40. The delivery system of claim 24, further comprising an anchor delivery device configured to deploy the valve anchor within the heart prior to delivery of the prosthetic valve by the valve delivery catheter. 41. The delivery system of claim 40, wherein the anchor delivery catheter comprises a steerable catheter having a distal end configured to bend to position the valve anchor within the heart. 42. The delivery system of claim 41, wherein the anchor delivery catheter is configured to extend over the string. 43. The delivery system of claim 40, wherein the anchor delivery device includes a steerable catheter configured to position a portion of the string from the first chamber of the heart into a second chamber of the heart. 44. The delivery system of claim 43, wherein the steerable catheter is configured to position the string in an everted configuration within the second chamber of the heart. 45. The delivery system of claim 43, wherein the steerable catheter is configured to form a U-shaped portion of the string within the second chamber of the heart. 46. ​​The delivery system of claim 43, wherein the anchor delivery catheter is configured to extend through a central opening in the valve anchor. 47. The delivery system of claim 24, wherein the valve delivery catheter includes an inner shaft and an outer sheath, and the prosthetic valve is compressed between the inner shaft and the outer sheath. 48. The delivery system of claim 47, wherein the inner shaft is configured to house a positioning tool, the positioning tool configured to adjust the position of the valve anchor once the valve anchor is wrapped around the chordae of the diseased valve. 49. The delivery system of claim 48, wherein the positioning tool is configured to translate within the inner shaft and extend from the distal end of the valve delivery catheter. 50. The system of claim 47, wherein the proximal retraction of the valve delivery catheter is configured to retract proximally to expand the prosthetic valve. 51. A delivery system for delivering a prosthetic valve to a diseased valve of the heart, comprising: a string configured to be connected to a valve anchor that encircles at least a portion of the chordae tendineae of the diseased valve, the string being further configured to extend from a location external to the heart, through at least a first chamber of the heart, and into a second chamber of the heart; a positioning tool configured to adjust the position of the valve anchor surrounding at least a portion of the chordae tendineae, the positioning tool including an elongated body configured to follow over the chordae and couple with a proximal portion of the valve anchor, the positioning tool including one or more regions configured to bend when an axial compressive force is applied to the positioning tool to configure the positioning tool into a predetermined shape. 52. The delivery system of claim 51, wherein the predetermined shape includes an inverted portion configured to be positioned subannularly relative to the valve anchor within the second chamber of the heart. 53. The delivery system of claim 51, wherein the predetermined shape includes a substantially U-shaped bend. 54. The delivery system of claim 51, wherein the one or more regions include one or more notches along a portion of the circumference of the elongate body, and wherein compression of the positioning tool reduces a width gap of the one or more notches. 55. The delivery system of claim 51, wherein the predetermined shape of the positioning tool includes a second bend at the distal end of the positioning tool that bends radially inward toward the center of the valve anchor. 56. The delivery system of claim 51, further comprising a valve delivery catheter configured to house the positioning tool therein, the positioning tool configured to translate within the valve delivery catheter and extend from a distal end of the valve delivery catheter. 57. The delivery system of claim 56, wherein the valve delivery catheter further houses the prosthetic valve therein. 58. The delivery system of claim 56, wherein the valve delivery catheter includes an inner shaft within a central opening of the prosthetic valve, the inner shaft configured to house the positioning tool therein. 59. The delivery system of claim 55, wherein proximal retraction of the valve delivery catheter expands the prosthetic valve. 60. The delivery system of claim 51, wherein the predetermined shape is configured to transmit a force applied to the valve anchor in a direction toward the surface of the diseased valve, thereby moving the valve anchor toward the surface of the diseased valve. 61. The delivery system of claim 51, wherein the positioning tool is configured to bend and stiffen when the string is pulled proximally. 62. The delivery system of claim 51, wherein the positioning tool is configured to bend and stiffen when the positioning tool is pushed distally. 63. A method for treating a diseased native valve of the heart, comprising: deploying an anchor from an anchor delivery catheter such that the anchor surrounds the chordae of the diseased native valve, wherein after the anchor is deployed, a string extends from the distal end of the anchor delivery catheter and is attached to the anchor; translating the distal end of the anchor delivery catheter from a first chamber of the heart to a second chamber of the heart, the distal end of the anchor delivery catheter being translated through a central opening of the deployed anchor; advancing the leash through the anchor delivery catheter until a loop of the leash is positioned within the second chamber of the heart; and retracting the string within the anchor delivery catheter until slack is removed from the string, wherein removing the slack releases tension on the string and causes the string to assume an everted configuration within the second chamber of the heart. 64. The method of claim 63, further comprising the step of retracting the anchor delivery catheter from the heart. 65. The method of claim 64, further comprising the step of causing a valve delivery catheter having a prosthetic valve stored therein to follow over said string. 66. The method of claim 65, wherein the step of causing the valve delivery catheter to track over the string includes the step of deploying a positioning tool over a portion of the string within the second chamber of the heart. 67. The method of claim 66, wherein the positioning tool is advanced until a distal end of the positioning tool engages a fitting attached to a proximal end of the anchor. 68. The method of claim 67, further comprising adjusting the position of the deployed anchor by translating the positioning tool to which the anchor is engaged. 69. The method of claim 68, wherein adjusting the position of the deployed anchor comprises moving the anchor closer to the annular plane of the diseased valve. 70. The method of claim 65, further comprising the step of releasing the prosthetic valve from the valve delivery catheter into the annulus of the diseased native valve and into the central opening of the anchor. 71. The method of claim 63, wherein the string includes a U-shaped bend within the second chamber of the heart when the string is in the inverted configuration. 72. The method of claim 63, wherein the step of deploying the anchor from the anchor delivery catheter includes deploying the anchor from a distal end of an anchor guide positioned within the anchor delivery catheter. 73. The method of claim 72, further comprising the step of distally translating the anchor guide relative to the anchor delivery catheter. 74. The method of claim 72, further comprising causing the anchor guide to assume a curved shape configured to facilitate deployment of the anchor around the chordae tendineae. 75. The method of claim 63, further comprising bending the anchor delivery catheter to steer the distal end of the anchor delivery catheter through a central opening in the anchor. 76. A delivery system for delivering a prosthetic valve to a diseased valve, comprising: an outer sheath; a hollow inner shaft defining a string lumen extending therethrough configured to receive a string; a delivery catheter comprising: a nosecone including a port at a distal end axially aligned with the ligament lumen and configured to receive the ligament, the nosecone reversibly coupling to and extending from the distal end of the delivery catheter and configured to retain the prosthetic valve within the delivery catheter. 77. The delivery system of claim 76, wherein the string lumen is positioned coaxially with the outer sheath. 78. The delivery system of claim 76, wherein the port is positioned coaxially with the outer sheath when the nosecone is coupled to the delivery catheter. 79. The delivery system of claim 76, further comprising an elongated positioning tool, the positioning tool comprising: following the string through the string lumen and the port to the distal end of the string; Orienting the valve anchor relative to the patient's anatomy A delivery system configured to: 80. The delivery system of claim 79, wherein the elongate positioning tool includes at least two preferentially bendable regions for adjusting the orientation of the valve anchor. 81. The delivery system of claim 80, wherein the adjusting of the orientation includes forming a first predetermined bend and a second predetermined bend in a first region and a second region of the at least two regions. 82. The delivery system of claim 81, wherein the first predetermined bend or the second predetermined bend comprises an angle of about 120 degrees to about 310 degrees. 83. The delivery system of claim 82, wherein the first predetermined bend or the second predetermined bend comprises an angle of about 70 degrees to about 100 degrees. 84. The delivery system of 82., wherein the first predetermined bend or the second predetermined bend comprises a radius of curvature of about 2 millimeters (mm) to about 20 mm. 85. The delivery system of claim 81, wherein the at least two regions have a reduced compressive stiffness relative to the remainder of the positioning tool. 86. The delivery system of claim 82, wherein the at least two regions are configured to flex upon application of a compressive force to the positioning tool along a longitudinal axis. 87. The delivery system of claim 80, wherein a first region of the at least two regions is spaced apart from a second region along a longitudinal axis of the positioning tool. 88. The delivery system of claim 80, wherein a first of the two regions is spaced apart from a second region along an azimuthal axis of the positioning tool. 89. The delivery system of claim 80, wherein when the positioning tool is extended to the distal portion of the string, the at least two regions are located distal to the distal end of the delivery catheter. 90. The delivery system of claim 80, wherein the at least two regions include a plurality of cutouts in an outer wall of the positioning tool. 91. The delivery system of claim 79, wherein the distal end of the positioning tool is shaped and sized to interact with the distal portion of the string. 92. The delivery system of claim 91, wherein the distal end of the positioning tool is shaped and sized to be able to interact with the proximal end of the distal portion of the string. 93. The delivery system of claim 91, wherein the distal end of the positioning tool includes a ramped portion shaped and sized to interact with a corresponding ramped portion at the proximal end of the distal portion of the string. 94. The delivery system of claim 76, further comprising a valve delivery member, the valve delivery member comprising: (a) shaped and sized for placement within the distal portion of the delivery catheter and for relative movement between the valve delivery member and the delivery catheter, and (b) for carrying the prosthetic valve; and A delivery system having an inner shaft defining a valve delivery member lumen configured to receive the string. 95. The delivery system of claim 94, wherein the valve delivery member includes the nosecone and the port is a distal end of the valve delivery member lumen. 96. A delivery system for delivering a prosthetic valve to a diseased valve, comprising: An outer shaft; a valve delivery member at a distal end of the outer sheath; a hollow inner shaft positioned within the outer shaft and the valve delivery member, the hollow inner shaft being coaxial with the outer shaft and configured to receive a string therethrough. 97. A delivery system for delivering a prosthetic valve to a diseased valve, comprising: an outer sheath defining a valve lumen sized to carry the prosthetic valve in a collapsed state; an inner shaft extending through the outer sheath and along a central axis of the outer sheath, the inner shaft defining a lacing lumen configured to receive a lacing; a delivery catheter comprising: a nosecone including a port at a distal end thereof coaxial with the ligament lumen, the nosecone being coupleable to the distal end of the delivery catheter to retain the prosthetic valve within the delivery catheter; A delivery system wherein the delivery catheter and the nosecone are separable for deployment of the prosthetic valve, the deployment including translation of the ligament lumen and / or the port relative to the ligament. 98. The delivery system of claim 97, wherein the ligament lumen is positioned along a central axis of the delivery catheter. 99. The delivery system of claim 97, wherein the inner shaft is coaxial with the outer sheath. 100. The delivery system of claim 97, wherein the port is centrally located at the distal end of the nosecone. 101. The delivery system of claim 97, wherein the string lumen and / or the port are configured to translate relative to the string while the string is maintained in a substantially fixed position. 102. The delivery system of claim 101, further comprising a positioning tool having an elongate body with a proximal end for extending into the proximal portion of the delivery catheter and a distal end for extending into the distal portion of the string, the positioning tool configured to translate along the string through the string lumen and the port and to couple with the distal portion of the string to maintain the string in the substantially fixed position. 103. The delivery system of claim 97, wherein the ligament lumen is configured to translate proximally relative to the ligament for said deployment of the prosthetic valve. 104. The delivery system of claim 97, wherein the port is configured to translate distally relative to the string for said deployment of the prosthetic valve. 105. The delivery system of claim 97, further comprising a valve delivery member, the valve delivery member comprising: an elongate body having an outer wall shaped and sized (a) for placement within the distal end of the delivery catheter and for relative movement between the valve delivery member and the delivery catheter, and (b) for carrying the prosthetic valve; A delivery system having an inner shaft coaxial with the outer wall and defining a valve delivery lumen extending therethrough, the valve delivery lumen configured to receive the string. 106. The delivery system of claim 105, wherein the valve delivery member includes the nosecone, and the port forms a distal end of the valve delivery member lumen. 107. The delivery system of claim 105, wherein the prosthetic valve is configured to expand to an expanded state upon deployment of the prosthetic valve. 108. A method of treating a diseased native valve in a patient, comprising: causing the delivery device to follow the string coupled to the anchor near the native annulus of the heart to the first chamber of the heart; further following the delivery device on the string into a second chamber of the heart to position a valve capsule carried by the delivery device beyond the native valve annulus; and exposing the valve capsule to deploy a prosthetic valve. 109. The method of claim 108, further comprising the step of advancing the string to the second chamber while maintaining the connection with the anchor. 110. The method of claim 108, wherein the step of advancing the string further includes forming a first bend and a second bend in the string within the second chamber. 111. The method of claim 110, wherein one of the first bend and the second bend comprises an angle of about 120 degrees to about 310 degrees. 112. The method of claim 110, wherein the step of advancing the string occurs between the step of following the delivery device into the first chamber and the step of following the delivery device into the second chamber. 113. The method of claim 110, wherein advancing the string comprises advancing the string through an inner diameter of the anchor. 114. The method of claim 110, wherein the advancing step is such that a majority of the string extending from the delivery device is subannular. 115. The method of claim 108, wherein the anchor is initially in a first position, and further comprising the step of moving the anchor to a second position. 116. The method of claim 115, wherein the step of moving the anchor occurs between the step of following the delivery device into the second chamber and the step of exposing the valve capsule. 117. The method of claim 115, further comprising the step of causing the positioning tool to follow over the string so that a distal end of the positioning tool is positioned near the junction of the string and the anchor. 118. The method of claim 117, wherein the distal end of the positioning tool couples with the distal end of the string. 119. The method of claim 118, wherein moving the anchor includes compressing at least a portion of the positioning tool and / or tensioning the string. 120. The method described in 117., wherein the step of moving the anchor includes adjusting at least one of the height or angle of the distal end of the positioning tool so that at least a portion of the anchor is approximately parallel to the annular plane of the native valve. 121. The method of claim 115, wherein the second position is closer to the native annulus than the first position. 122. The method of claim 118, wherein the step of following the delivery device into the first chamber includes inserting a proximal end of the string into a port located at a distal end of the delivery device. 123. The method of claim 122, wherein the port is located coaxially with the outer sheath of the delivery device. 124. A method of treating a diseased native valve in a patient, comprising: coaxially following a delivery device carrying a prosthetic valve along a tether to a first chamber of the heart, the tether having a distal end coupled to an anchor near a native annulus of the heart; further coaxially following the delivery device over the string into a second chamber of the heart to position the prosthetic valve beyond the native annulus; and exposing the prosthetic valve to deploy the prosthetic valve. 125. The method of claim 124, wherein the coaxially following step is through a port in a nosecone coupled to the distal end of the delivery device. 126. The method of claim 124, wherein the coaxially following step is through a lumen of a valve delivery member that carries the prosthetic valve within the delivery device. 127. The method of claim 124, wherein during the coaxially following step, a proximal end of the string extends from a portion of the delivery device that is external to the patient.

Claims

1. 1. A delivery system for delivering a prosthetic valve to a diseased heart valve, comprising: a string configured to connect to a valve anchor and further configured to extend from a location external to the heart through at least a first chamber of the heart and into a second chamber of the heart; a valve delivery catheter configured to extend over the string into the second chamber, the valve delivery catheter configured to hold the prosthetic valve therein and release the prosthetic valve into the valve anchor with the string connected to the valve anchor; A delivery system comprising:

2. 10. The delivery system of claim 1, wherein the string is configured to assume a substantially U-shape within the second chamber of the heart.

3. 10. The delivery system of claim 1, wherein the string is releasably attached to the valve anchor.

4. The delivery system of claim 3 , wherein a distal end of the string is configured to be releasably attached to a proximal end of the valve anchor.

5. 10. The delivery system of claim 1, wherein the valve anchor has a helical shape and the valve delivery catheter is configured to extend through a central opening in the valve anchor to align the prosthetic valve prior to release of the prosthetic valve.

6. 6. The delivery system of claim 5, wherein the valve delivery catheter is configured to axially align a central portion of the prosthetic valve with the diseased valve.

7. 10. The system of claim 1, wherein the distal end of the valve delivery catheter includes a nosecone having a port sized and shaped to allow the string to pass therethrough, the port having a central axis coaxial with the central axis of the valve delivery catheter.

8. 10. The delivery system of claim 1, further comprising a positioning tool configured to extend through the valve delivery catheter and over the string, the positioning tool configured to connect to the valve anchor and control the position of the valve anchor after it is deployed within the heart.

9. The delivery system of claim 8 , wherein the positioning tool includes one or more regions configured to bend to a predetermined shape.

10. 10. The delivery system of claim 9, wherein the region has a relatively reduced bending stiffness.

11. 10. The delivery system of claim 9, wherein the one or more regions include one or more cutouts configured to allow the regions to bend into the predetermined shape when a compressive force is applied to the positioning tool.

12. 10. The delivery system of claim 9, wherein the one or more regions are configured to bend to the predetermined shape when tension is applied to the string therein.

13. 10. The delivery system of claim 9, wherein the first region is configured to transition from a straight shape to a U-shape.

14. 14. The delivery system of claim 13, wherein the second region is configured to transition from a straight shape to a curved shape that bends radially inward toward a center of the valve anchor.

15. 10. The delivery system of claim 9, wherein the positioning tool includes a distal edge configured to engage a proximal edge of the valve anchor or a proximal edge of a fitting attached to a proximal end of the valve anchor.

16. 16. The delivery system of claim 15, wherein a distal edge of the positioning tool is beveled and configured to engage with a beveled edge of the proximal edge of the valve anchor that corresponds to the beveled distal edge, or with the proximal edge of a fitting attached to the proximal end of the valve anchor.

17. 10. The delivery system of claim 1, further comprising an anchor delivery device configured to deploy the valve anchor within the heart prior to delivery of the prosthetic valve by the valve delivery catheter.

18. 20. The delivery system of claim 17, wherein the anchor delivery device comprises a steerable catheter having a distal end configured to bend to position the valve anchor within the heart.

19. 20. The delivery system of claim 18, wherein the anchor delivery device is configured to extend over the string.

20. 18. The delivery system of claim 17, wherein the anchor delivery device comprises a steerable catheter configured to position a portion of the string from the first chamber of the heart into a second chamber of the heart.

21. 21. The delivery system of claim 20, wherein the steerable catheter is configured to position the string in an everted configuration within the second chamber of the heart.

22. 21. The delivery system of claim 20, wherein the steerable catheter is configured to form a U-shaped portion of the string within the second chamber of the heart.

23. 21. The delivery system of claim 20, wherein the anchor delivery device is configured to extend through a central opening in the valve anchor.

24. 10. The delivery system of claim 1, wherein the valve delivery catheter includes an inner shaft and an outer sheath, and the prosthetic valve is compressed between the inner shaft and the outer sheath.

25. 25. The delivery system of claim 24, wherein the inner shaft is configured to house a positioning tool, the positioning tool configured to adjust the position of the valve anchor once it is wrapped around the chordae of the diseased valve.

26. 26. The delivery system of claim 25, wherein the positioning tool is configured to translate within the inner shaft and extend from a distal end of the valve delivery catheter.

27. 25. The system of claim 24, wherein proximal retraction of the valve delivery catheter is configured to retract proximally to expand the prosthetic valve.

28. 1. A delivery system for delivering a prosthetic valve to a diseased valve of the heart, comprising: a string configured to be connected to a valve anchor that encircles at least a portion of the chordae tendineae of the diseased valve, the string being further configured to extend from a location external to the heart, through at least a first chamber of the heart, and into a second chamber of the heart; a positioning tool configured to adjust the position of the valve anchor surrounding at least a portion of the chordae tendineae, the positioning tool including an elongated body configured to follow over the chords and couple with a proximal portion of the valve anchor, the positioning tool including one or more regions configured to bend when an axial compressive force is applied to the positioning tool to configure the positioning tool into a predetermined shape.

29. 29. The delivery system of claim 28, wherein the predetermined shape includes an everting portion configured to be positioned subannularly relative to the valve anchor within the second chamber of the heart.

30. 29. The delivery system of claim 28, wherein the predetermined shape comprises a substantially U-shaped bend.

31. 29. The delivery system of claim 28, wherein the one or more regions include one or more cutouts along a portion of the circumference of the elongate body, and wherein compression of the positioning tool reduces a width gap of the one or more cutouts.

32. 30. The delivery system of claim 28, wherein the predetermined shape of the positioning tool includes a second bend at a distal end of the positioning tool that bends radially inward toward a center of the valve anchor.

33. 29. The delivery system of claim 28, further comprising a valve delivery catheter configured to house the positioning tool therein, the positioning tool configured to translate within the valve delivery catheter and extend from a distal end of the valve delivery catheter.

34. 34. The delivery system of claim 33, wherein the valve delivery catheter further houses the prosthetic valve therein.

35. 34. The delivery system of claim 33, wherein the valve delivery catheter includes an inner shaft within a central opening of the prosthetic valve, the inner shaft configured to house the positioning tool therein.

36. 34. The delivery system of claim 33, wherein proximal retraction of the valve delivery catheter expands the prosthetic valve.

37. 29. The delivery system of claim 28, wherein the predetermined shape is configured to transfer a force applied to the valve anchor in a direction toward a face of the diseased valve to move the valve anchor toward the face of the diseased valve.

38. 29. The delivery system of claim 28, wherein the positioning tool is configured to bend and stiffen when the string is pulled proximally.

39. 30. The delivery system of claim 28, wherein the positioning tool is configured to bend and stiffen when the positioning tool is pushed distally.

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