Dispatch system

Abstract

A delivery system and method are provided for delivering a valve anchor and a prosthetic valve to a native valve annulus. The anchor can be deployed near the native valve annulus by a string attached to the anchor. A portion of the string can be positioned in an inverted configuration under the deployed anchor for advantageous positioning to adjust the anchor position and / or deployment of the prosthetic valve. A positioning tool can be used to follow over the string and properly position the anchor. The positioning tool can be configured to transition to a stiffened state including one or more bends that allows efficient positioning of the deployed anchor and provides room for deployment of the prosthetic valve. Once the anchor is properly positioned, the prosthetic valve can be deployed within the prosthetic valve annulus and valve anchor.

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 on July 7, 2020, the entire disclosure of which is incorporated herein by reference in its entirety. Incorporation by Reference

[0002] All publications and patent applications mentioned in this specification are hereby 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

Problems to be Solved by the Invention

[0002]

[0003] Blood flow between the heart chambers (in other words, the atrioventricular chambers) is controlled by native valves, namely, the mitral valve, aortic valve, pulmonary valve, and tricuspid valve. 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 an abnormal anatomical form and / or function of at least one valve. For example, a valve may suffer from valvular insufficiency, also called regurgitation, where the valve does not close completely and allows blood to flow backward. Valvular stenosis may prevent the valve from opening normally. Other diseases may also lead to valve dysfunction. Drug therapy may be used to treat these diseases, but in many cases, a defective valve may need to be repaired or replaced at some point in the patient's lifetime. Existing valves and surgical repair and / or replacement procedures are relatively high risk, have limited lifespan, and / or may be highly invasive. Some minimally invasive transcatheter options are available, but they are generally limited to aortic valve procedures, have limited flexibility for each patient, and often take longer than the desired time for implantation. Therefore, it would be desirable to provide minimally invasive procedures for the repair and replacement of heart valves, including the mitral valve, faster surgical methods, and / or prosthetic valves that can accommodate a variety of individual patients.

[0003]

[0004] In addition, existing valve repair / replacement procedures are often complex and time-consuming. Currently available procedures often require the placement of multiple components, such as an artificial valve and a mechanism for fixing it to the native anatomy. Such procedures generally use multiple delivery catheters for carrying the various components and separate delivery of each component to the valve, which can be time-consuming, complex, and / or risky (especially when components are delivered sequentially). For example, some devices include rotating fixation elements for capturing native anatomy, such as chordae tendineae, in order to shorten the delivery time. However, such fixation elements often inadvertently capture, pull on, and torque the chordae tendineae during rotation, which can stress and damage the chordae tendineae and potentially result in additional medical intervention for the patient. In addition, such fixation elements may require extrusion from a thin (e.g., elongate) delivery configuration to an expanded configuration within or near the native valve. In at least some cases, extrusion of the fixation element can be complex and may not reliably deploy in the correct expanded configuration relative to the delivery device and / or the native anatomy. As a result of incorrect deployment, additional time may be required to retract and redeploy the fixation element, resulting in a more complex fixation procedure and / or damage to the native tissue. Accordingly, it would be desirable to provide a valve assembly for valve replacement and repair that is faster, less complex, less risky, and more reliably deployable.

Means for Solving the Problem

[0004]

[0005] This specification describes a delivery system and method for delivering a valve anchor and an artificial valve to the native annulus. The anchor can have a helical shape and can be deployed around the chordae tendineae and / or leaflets of the native annulus. A tether (i.e., a cord) 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 artificial valve into and within the valve anchor. The counterforce between the artificial valve and the anchor can fix the artificial valve at a predetermined position within the annulus of the native valve.

[0005]

[0006] Before deploying the artificial valve, a positioning tool can be used to correctly adjust the position of the deployed valve anchor towards a selected position. For example, when the artificial valve is expanded and deployed, it may be preferable for the valve anchor to be axially aligned with the central portion of the artificial valve. Also, it may be desirable for the valve anchor to be as close as possible to the surface of the native annulus, which may require raising the valve anchor upward from its initially deployed position. At least a portion of the tether can be positioned under the deployed anchor so that the positioning tool can be advantageously positioned to adjust the anchor position. The tether can be positioned at least partially in an inverted configuration within the ventricle. The positioning tool can be configured to transition (i.e., shift) to a stiffened state that includes one or more bends such that the positioning tool can efficiently transmit force to the anchor deployed from a sub-annular position.

[0006]

[0007] According to one aspect, a method of treating a diseased native valve in a patient includes surrounding the chordae tendineae of the diseased native valve with an anchor to which a tether is attached, advancing (or in other words, moving) a portion of the tether from a first chamber of the heart through the annulus of the diseased native valve to a second chamber of the heart with the anchor positioned around the chordae tendineae, such that the advancement of the tether forms a bend in the tether within the second chamber, advancing, following the tether with a valve delivery device, and releasing an artificial valve from the valve delivery device into the anchor within the annulus of the diseased native valve.

[0007]

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

[0008]

[0009] According to some aspects, a delivery system for delivering an artificial valve to a diseased valve of the heart includes a tether 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, and a valve delivery catheter configured to extend over the tether and into the second chamber, hold the artificial valve therein, and release the artificial valve within the valve anchor with the tether connected to the valve anchor.

[0009]

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

[0010]

[0011] According to one aspect, a delivery system for delivering an artificial 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 being further configured to extend from a location outside the heart through at least a first chamber of the heart 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 elongate body configured to follow along 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 and to assume a predetermined shape.

[0011]

[0012] In these aspects, the predetermined shape may include an inversion portion configured to be positioned subannularly relative to the valve anchor within the second chamber of the heart. In these aspects, the predetermined shape may include a substantially U-shaped bend. In these aspects, one or more regions can include one or more notches along a portion of the perimeter of the elongate body, with compression of the positioning tool narrowing the gap width of the one or more notches. In these aspects, 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 aspects, the system may further include a valve delivery catheter configured to house the positioning tool therein, the positioning tool being configured to translate within the valve delivery catheter and extend from the distal end of the valve delivery catheter. In these aspects, the valve delivery catheter can further house an artificial valve therein. In these aspects, the valve delivery catheter may include an inner shaft configured to house the positioning tool therein within the central opening of the artificial valve. In these aspects, retraction of the valve delivery catheter proximally can expand the artificial valve. In these aspects, the predetermined shape can be configured to transmit the force applied to the valve anchor in a direction toward the diseased valve face so as to move the valve anchor toward the diseased valve face. In these aspects, the positioning tool can be configured to bend and stiffen when the tether is pulled proximally. In these aspects, the positioning tool can be configured to bend and stiffen when the positioning tool is pushed distally.

[0012]

[0013] In some embodiments, a method of treating a diseased heart valve includes deploying an anchor from an anchor delivery catheter such that the anchor surrounds a chord of the diseased valve, advancing the distal end of the anchor delivery catheter from a first chamber of the heart to a second chamber of the heart such that the distal end of the anchor delivery catheter is advanced through a central opening of the deployed anchor, advancing the tether through the anchor delivery catheter until a loop of the tether is disposed within the second chamber of the heart, and retracting the tether within the anchor delivery catheter until slack is removed from the tether, wherein removal of the slack releases tension on the tether and causes the tether to assume an inverted 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 can further include following the tether over the valve delivery catheter, which has an artificial valve stored therein. In these embodiments, following the tether over the valve delivery catheter can include deploying a positioning tool within a second chamber of the heart over a portion of the tether. In these embodiments, the positioning tool can be advanced until the distal end of the positioning tool engages an attachment that is attached to the 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 can include moving the anchor closer to the annulus surface of the diseased valve. In these embodiments, the method may further include releasing the artificial valve from the valve delivery catheter into the central opening of the anchor within the annulus of the diseased native valve. In these embodiments, the tether can include a U-shaped bend within a second chamber of the heart when the tether is in an inverted configuration. In these embodiments, deploying the anchor from the anchor delivery catheter can include deploying the anchor from the distal end of an anchor guide positioned within the anchor delivery catheter. In these embodiments, the method may further include translating the anchor guide distally relative to the anchor delivery catheter. In these embodiments, the method may further include causing the anchor guide to assume a curved shape configured to facilitate deployment of the anchor around the chordae tendineae of the anchor. In these embodiments, the method may further include bending the anchor delivery catheter to maneuver the distal end of the anchor delivery catheter through the central opening of the anchor.

[0014]

[0015] According to one aspect, a delivery system for delivering an artificial valve to an affected 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 nose cone including a port at a distal end axially aligned with the tether lumen and configured to receive the tether, the nose cone being reversibly coupled to the distal end of the delivery catheter, extending from the distal portion of the delivery catheter, and formed to hold the artificial valve within the delivery catheter.

[0015]

[0016] In these aspects, the tether lumen can be positioned coaxially with the outer sheath. In these aspects, the port can be positioned coaxially with the outer sheath when the nose cone is coupled to the delivery catheter. In these aspects, the delivery system can further include an elongate positioning tool configured to follow up the tether through the port within the tether lumen to the distal end of the tether and to adjust the orientation of the valve anchor relative to the patient's anatomy. In these aspects, the elongate positioning tool can include at least two regions that are preferentially bendable for adjustment of the orientation of the valve anchor. In these aspects, the adjustment of the orientation can include the formation of a first predetermined bend and a second predetermined bend in a first region and a second region of at least two regions. In these aspects, the first predetermined bend or the second predetermined bend can include an angle of about 120 degrees to about 310 degrees. In these aspects, the first predetermined bend or the second predetermined bend can have an angle of about 70 degrees to about 100 degrees. In these aspects, the first predetermined bend or the second predetermined bend can have a radius of curvature of about 2 millimeters (mm) to about 20 mm. In these aspects, the at least two regions can have a relatively reduced compressive stiffness in relation to the remainder of the positioning tool. In these aspects, the at least two regions can be formed to bend when a compressive force is applied to the positioning tool along the longitudinal axis. In these aspects, a first region of the at least two regions can be spaced apart from a second region along the longitudinal axis of the positioning tool. In these aspects, the first region of the at least two regions can be spaced apart from the second region along the azimuthal axis (in other words, the horizontal axis) of the positioning tool. In these aspects, the at least two regions can be positioned distally relative to the distal end of the delivery catheter when the positioning tool is extended to the distal portion of the tether. In these aspects, the at least two regions can include a plurality of notches in the outer wall of the positioning tool. In these aspects, 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 have a shape and size that is interactable with the proximal end of the distal portion of the tether. In these embodiments, the distal end of the positioning tool can include an inclined portion having a shape and size that interacts with a corresponding inclined portion of the proximal end of the distal portion of the tether. In these embodiments, the delivery system can further include a valve delivery member, the valve delivery member being configured 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) carrying an artificial valve, and having an inner shaft that defines a valve delivery member lumen shaped and sized to receive the tether. In these embodiments, the valve delivery member can include a nose cone, and the port is the distal end of the valve delivery member lumen.

[0016]

[0017] According to some embodiments, a delivery system for delivering an artificial valve to an affected valve includes an outer shaft, a valve delivery member at the distal end of an 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.

[0017]

[0018] According to some embodiments, a delivery system for delivering an artificial valve to an affected valve includes a delivery catheter including an outer sheath defining a valve lumen sized to carry the artificial valve in a folded state, and an inner shaft passing through the outer sheath and extending along a central axis of the outer sheath, the inner shaft defining a tether lumen configured to receive a tether, and a nose cone including a port at a distal end coaxial with the tether lumen, the nose cone being connectable to the distal end of the delivery catheter to hold the artificial valve within the delivery catheter, the delivery catheter and the nose cone being separable for deployment of the artificial 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 disposed at the center of the distal end of the nose cone. In these embodiments, the tether lumen and / or port can be configured to translate 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 configured to translate through the port along the tether within the tether lumen and couple to the distal end of the tether to maintain the tether in a substantially fixed position. In these embodiments, the tether lumen can be configured to translate proximally relative to the tether for deployment of the prosthetic valve. In these embodiments, the port can be configured to translate distally 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 including an elongate body having an outer wall sized and shaped 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) carrying a prosthetic valve, the elongate body 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 nose cone, the port forming the distal end of the valve delivery member lumen. In these embodiments, the prosthetic valve can be configured to expand to an expanded state upon deployment of the prosthetic valve.

[0019]

[0020] According to some embodiments, a method of treating a diseased native valve in a patient includes tracking a delivery device over a tether coupled to an anchor near the native valve annulus of the heart to a first chamber of the heart, further tracking the delivery device over the tether to 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 connection 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 include an angle of from about 120 degrees to about 310 degrees. In these embodiments, advancing the tether can 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 it through the inner diameter of the anchor. In these embodiments, the advancement can be such that most of the tether extending from the delivery device is under the valve ring. In these embodiments, the anchor can initially be located in a first position and includes moving the anchor to a second position. In these embodiments, moving the anchor can be between following the delivery device into the second chamber and exposing the valve capsule. In these embodiments, the method may further include following the positioning tool over the tether such that the distal end of the positioning tool is positioned near the connection between the tether and the anchor. In these embodiments, the distal end of the positioning tool can contact 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 applying tension to 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 such that at least a portion of the anchor is substantially parallel to the face of the valve ring of the self-valve. In these embodiments, the second position can be closer to the self-valve ring than the first position. In these embodiments, following 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 can be positioned coaxially with the outer sheath of the delivery device.

[0021]

[0022] According to one aspect, a method of treating a diseased native valve in a patient includes coaxially advancing a delivery device carrying an artificial valve along a tether whose distal end is coupled to an anchor near the native valve annulus of the heart to a first chamber of the heart, further coaxially advancing the delivery device along the tether over the native valve annulus to a second chamber of the heart to position the artificial valve beyond the native valve annulus, and exposing the artificial valve to deploy the artificial valve.

[0022]

[0023] In these aspects, the coaxial advancement can occur through a port of a nose cone coupled to the distal end of the delivery device. In these aspects, the coaxial advancement can occur through a lumen of a valve delivery member that carries the artificial valve within the delivery device. In these aspects, during coaxial advancement, the proximal end of the tether can extend from a portion of the delivery device that is external to the patient.

[0023]

[0024] The above and other aspects are described herein.

[0024]

[0025] The novel features of the invention are particularly pointed out and distinctly claimed in the appended claims. The features and advantages of the invention will be better understood from the following detailed description of example embodiments in which the principles of the invention are utilized, along with the accompanying drawings.

Brief Description of the Drawings

[0025]

Figure 1A

[0026] A figure showing an embodiment of a method of delivering an anchor for an artificial valve near a native valve.

Figure 1B

Figure 1C

Figure 1D

Figure 1E

Figure 1F

Figure 1G

Figure 2A

[0027] FIG. 2 shows an embodiment of a tether inversion procedure as part of the delivery of an artificial valve.

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 2H

Figure 3A

[0028] FIG. 3 shows an embodiment of a method for delivering an artificial valve to an anchor pre - placed near a native valve annulus.

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 3I

Figure 3J

Figure 4A

[0029] FIG. 4A is a diagram showing an embodiment of the interaction between the distal end of the tether and the distal end of the positioning tool.

Figure 4B

Figure 4C

Figure 5A

[0030] FIG. 5A is a diagram showing an embodiment of the positioning tool and the valve delivery catheter used for delivering the artificial valve.

Figure 5B

Figure 6A

[0031] FIG. 6A is a diagram showing a part of the positioning tool having an arrangement configuration of preferentially bendable regions.

Figure 6B

Figure 6C

Figure 6D

Figure 7A

[0032] FIG. 7A is a perspective view showing an artificial valve carried within a valve delivery catheter.

Figure 7B

Figure 7C

Figure 7D

Figure 8

[0033] It is a flowchart showing a method of deploying an artificial valve using a tether.

Figure 9

[0034] It is a flowchart showing a method of deploying an artificial valve using a tether and a positioning tool.

Figure 10A

[0035] FIG. 10A is a side view showing an exemplary positioning tool.

Figure 10B

Figure 11A

[0036] FIG. 11A is a side view showing another exemplary positioning tool.

Figure 11B

Figure 12

[0037] It is a flowchart showing a method of delivering an artificial valve including inverting a tether to follow the artificial valve.

Figure 13A

[0038] FIG. 13A is a view showing an image of an exemplary tether inversion procedure performed within a lamb's heart.

Figure 13B

Figure 13C

Figure 14A

[0039] Figure 14A is a diagram showing an image of an example of the use of an intravascular positioning tool for controlling the axial height of an anchor.

Figure 14B

Figure 14C

Figure 15A

[0040] Figure 15A is a diagram showing an image of an example of the deployment of an artificial valve within the heart, demonstrating problems related to the length of the positioning tool.

Figure 15B

DETAILED DESCRIPTION OF THE INVENTION

[0026]

[0041] In this specification, for example, during mitral valve replacement, a device and method for use in delivering a valve frame and a valve will be described. The device and method can be used in conjunction with a pre-positioned anchor that is used to deliver the valve frame. The device and method can be used to transition (e.g., move) an anchor from a first position spaced apart from the native valve annulus (e.g., within the sub-valvular space) to a second position closer to the native valve annulus prior to deployment of the artificial valve.

[0027]

[0042] Figures 1A-1G illustrate a method of delivering an anchor of an artificial valve system using an anchor delivery device or system. In Figure 1A, a transseptal puncture is performed. Next, a guidewire 102 is passed through the puncture site and positioned within the left atrium 104 or, across the mitral valve, within the left ventricle 106. In Figure 1B, an outer sheath 108 (also referred to as an anchor delivery catheter or a steerable catheter) is advanced 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 inner dilator 110. Thereafter, the guidewire 102 and the inner dilator 110 (if used) are removed from the outer sheath 108. In Figure 1C, an inner sheath having an anchor guide 112 disposed distally therein 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 is configurable 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 the anchor guide 112 within the tube 108. In some embodiments, the distal portion of the outer sheath 108 is bendable between a straight configuration and a bent configuration. Such bending can be controlled, for example, at a handle operably connected to the anchor delivery catheter. In Figure 1D, when the anchor guide 112 is positioned in a selected orientation, an anchor 114 is extruded from the distal tip of the anchor guide 112. The geometry (e.g., curvature) of the anchor guide 112 can impart a twist to the anchor 114 upon deployment.

[0028]

[0043] In FIG. 1E, the anchor guide 112 biases the anchor 114 to be disposed coaxially within the atrium 104 with the distal portion of the outer sheath 108. In FIG. 1F, the entire delivery system 116 can be pushed and maneuvered (e.g., via a steering mechanism within the outer sheath 108) toward the apex of the ventricle 106, over the mitral valve. In some embodiments, reverse rotation of the anchor 114 (via reverse rotation of the inner shaft and guide 112) may assist in advancing the anchor over the mitral valve without entrapment of the chordae tendineae. When 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) enables the anchor 114 to surround the mitral valve leaflets and chordae tendineae. In some embodiments, the anchor 114 is disposed (e.g., initially) toward the apex to facilitate avoiding interference with the movement of the mitral valve leaflets. In FIG. 1G, the outer sheath and inner sheath are removed together with the anchor guide 112, leaving the tether 118 in place. The tether remains attached to the anchor 114 at the fixture 128 and extends outside the patient through the delivery path. Embodiments of methods and devices for delivering an anchor / artificial valve are disclosed in U.S. Patent Application No. 16 / 824,576, filed Mar. 19, 2020, and U.S. Patent Application No. 16 / 594,946, filed Oct. 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 referred to as a valve delivery catheter or valve delivery member) follows to deliver an artificial valve. The valve delivery device can include a lumen through which the tether passes and follows. In some embodiments, the tether can be inverted or looped within a chamber of the heart, such as a ventricle. 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 so as to extend through the mitral valve annulus (e.g., into the atrium) and back. Inverting the tether is advantageous because it allows access to the anchor from a sub-valvular position. In some examples, the loop of the tether is formed within and / or received within the central opening (e.g., inner radius) of the anchor. The tether looped within the central opening of the anchor can enable coaxial delivery of the valve on the tether. Also, coaxial tracking of the valve delivery device on the tether can advantageously improve the advancement of the valve delivery device through the patient's anatomy. For example, the tip of the valve delivery device can be guided through an (existing) puncture site within the septum via a coaxial tether to improve crossing of the valve delivery device during a transseptal procedure. Also, since the tether can also be used as a guidewire, coaxial delivery can reduce the total number of devices for valve delivery. Coaxial tracking of the valve delivery device on the tether is advantageous because it can improve the placement of (1) the distal end of the valve delivery device relative to the chamber of the native (i.e., natural) heart valve (e.g., the left ventricle), and / or (2) the prosthetic valve relative to the valve 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. Namely, 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] Figures 2A-2H illustrate an exemplary method of inverting a tether 118, according to some embodiments, as part of an anchor delivery of an artificial valve system within a patient. Figure 2A shows an anchor guide 112 after being pushed at least partially across the mitral valve surface and used to position an anchor 114 such that the anchor 114 surrounds the mitral valve leaflet tip and / or chordae tendineae (as shown in Figure 1F). In Figure 2B, the distal end of the anchor guide 112 is retracted proximally into the outer sheath 108, and the tether 118 is exposed from the distal end of the outer sheath 108. The tether 118 can be configured to be flexible enough to bend laterally when passing through the patient's blood vessels and heart, but also rigid enough to be resistant to kinking when manipulated once it exits the outer sheath 108. The rigidity 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 Figure 2C, the steering mechanism of the outer sheath 108 is used to advance the outer sheath 108 through the native annulus (e.g., coaxially). Additionally, the tether 118 can be fed distally through the outer sheath 108 to create a slack 122 in the tether 118. Generally, a tether with slack can include a state of the tether where a progressive (e.g., slight) retraction of the proximal side of the tether 118 serves to shorten the length of the tether 118 exposed from the outer sheath 108 without applying a substantial force to the anchor 114. In this context, a substantial force is a force of sufficient magnitude to change the position of the anchor 114 relative to the native biological structure. The slack in the tether 118 can cause the tether 118 to form coils or loops within the atrium 104 and / or ventricle 106 in a portion of the tether 118. Although coils and loops of the tether are formed within the ventricles of the heart shown in the examples of Figures 2A-2H, other embodiments of the present disclosure will be appreciated to include, instead of, or in addition to, coils and loops of the tether formed within the atrium.

[0032]

[0047] In FIG. 2D, the distal end of the outer sheath 108 passes through the central opening of the valve annulus anchor 114, extends beyond the plane of the anchor 114, and is further advanced so that the loop of the tether 118 can pass through the central opening of the anchor and enter the left ventricle 106. In FIG. 2E, the tether 118 is further fed 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, due to the tension applied to the tether 118 when the tether 118 is advanced through the annulus of the anchor 114, the tether 118 may be constrained within the anchor 114. In FIG. 2G, in order to enable access to the anchor 114 from a subannular position relative to the anchor 114 during delivery of the prosthetic valve, with sufficient length of the tether 118 still remaining within the ventricle 106, the tether 118 is retracted relatively proximally with respect 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. As shown in the figure, thereby, the tether 118 can unwind from the constrained / wound configuration to the inverted configuration, the tether 118 turns around, and the subannular portion of the tether 118 assumes a U-shaped bend. In FIG. 2H, the outer sheath 108 is retracted proximally, and the tether 118 is left in the inverted position within the left ventricle 106 for subsequent coaxial delivery of the prosthetic valve over the tether 118.

[0033]

[0048] The procedures shown in FIGS. 2A-2H are presented as a series of operations, but it should also be understood that one or more of these operations may be performed in a different order. For example, using some different combinations of forward / retraction of the outer sheath 108 in the direction toward / away from the anchor 114 and forward / retraction of the tether 118 relative to the outer sheath 108, the tether 118 may be positioned in the inverted configuration within the ventricle 106.

[0034]

[0049] Figures 3A - 3J show an embodiment of the delivery of a valve after an anchor has already been placed by an anchor delivery device or system (as shown, for example, in Figure 2H). A tether 118 can be attached to an anchor 114 that at least partially surrounds the chordae tendineae 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, during and / or prior to the delivery of the prosthetic valve, the tether 118 can be positioned from a first configuration (such as that shown, for example, in Figure 2F) to a second configuration (such as that shown, for example, in Figure 2G) using an anchor delivery catheter. In some embodiments, the tether 118 in the second configuration includes at least one bend that reverses or substantially reverses the orientation of the tether 118 (i.e., the tether 118 can include a U-shaped bend). In some embodiments, the U-shaped bend or reversal of the tether 118 can be caused to occur near or adjacent to the apex of the heart (e.g., 120 in Figure 3A). In some embodiments, the reversed configuration of the tether 118 is such that with the distal end of the tether attached to the anchor 114, the central axial portion of the tether 118 is positioned relatively centrally with respect to the native valve annulus 145, leaflets, and / or chordae tendineae. In some embodiments, one or more bends of the tether 118 are such that the tether 118 can maintain its connection to the anchor while the distal tip of the valve delivery catheter 302 extends into the second chamber 106 and provides a (substantially) coaxial follow-up path for aligning the constricted portion of the prosthetic valve with the native valve annulus 145 (121 in Figure 3A). In some embodiments, the second configuration (i.e., the reversed configuration) of the tether 118 is such that the valve delivery catheter 302 can be caused to follow (e.g., coaxially) along the tether 118 from the first chamber 104 through the valve annulus into the second chamber 106. In other embodiments, one or more bends of the tether 118 are such that the tether 118 can maintain its connection to the anchor 114 when the proximal end of the anchor 114 faces into the ventricle.

[0036]

[0051] As shown in FIG. 3A, the tether 118 can have a sufficient length such that the proximal portion is outside the patient, the central portion passes through the patient's vasculature, and the distal portion is attached to the anchor 114. Further, the central portion can extend through a transseptal puncture portion into a first chamber (e.g., atrium) of the heart, pass over a heart valve (e.g., mitral valve), and then loop or reverse (i.e., in the opposite direction) in a U-shaped bend within a second chamber (e.g., ventricle) of the heart. In some embodiments, as shown in FIG. 3A, the tether 118 can be advanced to bend in both the first chamber 104 (e.g., bend 119) and the second chamber 106 (e.g., bends 120, 121) of the heart. In some embodiments, at least two bends of the tether 118 include different bend angles. In some embodiments, at least two bends of the tether 118 have different radii of curvature. In some embodiments, at least two bends of the tether 118 have substantially the same bend angle. In some embodiments, at least two bends of the 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 of the tether 118 contact a portion of the inner wall of the first chamber 104 and / or the second chamber 106. Contact of a portion of the tether 118 with the wall of the heart chamber can facilitate the formation of one or more bends of the tether 118. The contact with a portion of the inner wall can be for a selected (e.g., predetermined) time controlled by the operator of the valve delivery catheter.

[0037]

[0052] Depending on the embodiment, the tether 118 can be maintained in a substantially tension - free state (before and / or during following the valve delivery catheter 302 thereon). The tether 118 may be formed to be sufficiently resistant to kinking so that when pushed (e.g., for its delivery or for following the valve delivery catheter 302 thereon), it can be advanced through and / or along the patient's biological structure and / or through the valve delivery catheter 302. Depending on the embodiment, the tether 118 is sufficiently flexible so that when pushed, it produces a curved portion (e.g., one or more bending portions as described herein).

[0038]

[0053] As shown in FIG. 3B, the valve delivery catheter 302 can be tracked over the tether 118 through the transseptal puncture and 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 central point or axis that is coaxial with the central axis of the valve delivery catheter 302). The port 304 may be in the nose cone, which is the conical portion at the distal end of the valve delivery catheter 302. The valve delivery catheter 302 can have an inner hollow shaft (an "inner shaft") that forms a lumen sized and shaped to receive the tether 118 (see, e.g., 520 in FIG. 5A). The inner shaft forming the lumen of the valve delivery catheter 302 can be located substantially centrally, e.g., along the central axis of the valve delivery catheter 302. The prosthetic valve 510 can be compressible within the space between the inner shaft and the 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 can be connectable to the inner shaft forming the lumen of the valve delivery catheter 302. The port 304 can be located at the distal end (e.g., the tip) of the valve delivery catheter 302. In some embodiments, the tether 118 is placed within the port 304 with the valve delivery catheter 302 outside the patient, and then the valve delivery catheter 302 is 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 into the second chamber 106 of the heart (e.g., the left ventricle).

[0039]

[0054] FIG. 3C shows an exemplary coaxial valve delivery catheter 302 that follows up on the tether 118 until a valve delivery member 308 (e.g., a valve capsule) carrying an artificial valve is positioned beyond the native valve annulus 145. In some embodiments, the artificial valve is held directly within the valve delivery catheter 302 without using the valve delivery member 308. For example, the artificial valve 302 can be fitted within the valve delivery catheter 302 at the distal portion of the valve delivery catheter 302 in a folded state. In some embodiments, the artificial valve is coupled to the nose cone of the valve delivery catheter 302 and deployed by separation of the nose cone and the distal end of the valve delivery catheter. In some embodiments, the artificial valve is deployed by using a pusher catheter to move the artificial 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, most (e.g., all) of the tether 118 that can 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 position 130 while the valve delivery catheter 302 is being made to follow on the tether 118 beyond the native valve annulus.

[0040]

[0055] In some embodiments, the anchor 114 can be positioned at a first position 130 that is relatively spaced from the valve annulus while the valve delivery catheter 302 is being made to follow on the tether 118. At the first spaced position 130, the anchor 114 can be moved far enough from the valve annulus to minimize interference between the anchor 114 and the movement of the native valve leaflets and / or chordae tendineae. The first spaced position 130 of the anchor 114 relative to the valve annulus can, for example, suppress the occurrence of paravalvular leakage (PVL) due to interference between the anchor and the native valve leaflets and / or chordae tendineae prior to deployment of the artificial valve. In some embodiments, the anchor 114 at the first spaced position 130 is about 10 millimeters (mm) to about 40 mm away from the native valve annulus in the apical direction.

[0041]

[0056] Sometimes, after following 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 (spaced-apart) position to a second position closer to or adjacent to the native valve annulus 145. By positioning the anchor 114 in a closer position (e.g., adjacent to or abutting the native valve annulus 145), it is possible to facilitate the sealing of the prosthetic valve frame and the 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 spaced-apart position 130 to the second closer position 140 using a tether (e.g., under tension) and / or a positioning tool (e.g., stiffened), 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 valve annulus 145. As a result of the movement of the anchor 114, 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 substantially between the plane including the anchor and the plane of the native valve (e.g., annulus)) can occur.

[0042]

[0057] In some embodiments, a positioning tool can be used to adjust the position of the anchor 114 after the tether 78 is reversed. FIG. 3D shows an example of a positioning tool 306 that is made to follow distally along the reversed tether 118 after the valve delivery catheter 302 is positioned beyond the native valve annulus. In some embodiments, the positioning tool 306 can be or include a hollow elongate body and can fit over the tether 118 within the lumen of the valve delivery catheter 302 and / or the valve delivery member 308 and have sufficient lubricity, shape, and size to follow. The positioning tool 306 can follow over the tether 118 and be flexible enough to assume the curvature of the tether 118. The positioning tool 306 can be configured to bend and rotate as it follows the tether 118. The positioning tool 306 can follow the variable curvatures that the tether 118 can assume within the left ventricle 106. The flexibility of the positioning tool 306 during following can reduce the likelihood that the positioning tool 306 interacts with and / or loads and rotates or releases the enclosure of the anchor 114. The proximal portion of the positioning tool 306 can extend outside the patient and can fit into a control portion of the valve delivery catheter 302 that enables operation of the valve delivery catheter 302. The control portion can include, for example, one or more actuators (e.g., buttons, knobs, rotary members, and / or switches) of a handle at the proximal end of the valve delivery catheter 302. The operation of the positioning tool 306 can include translation, rotation, and / or compression. The positioning tool 306 can be advanced distally over the tether 118 until the distal end of the positioning tool 306 connects (e.g., interfaces) with the distal portion of the tether 118 and / or the proximal end of the anchor 114. In some cases, the distal end of the positioning tool 306 can connect (e.g., couple) to a fixture that removably attaches the proximal end of the anchor 114 to the distal end of the tether 118. The positioning tool can be formed of any material or combination of materials such as those used to form the tether.

[0043]

[0058] Axial compression of the positioning tool 306 can be used to stiffen the positioning tool 306 and / or to cause a predetermined curvature and / or bend in a selected portion of the positioning tool (such as a surrounded tether as well). For example, refer to FIGS. 4A-4C. The selected portion can preferably be a bendable region (see, for example, FIGS. 4A-4C). In some embodiments, stiffening the positioning tool 306 biases the tether 118 to assume a predetermined shape and / or form. Bending / compressing / stiffening of the positioning tool 306 can be driven, for example, by pushing the positioning tool 306 relative to the tether 118 and / or pulling the tether 118 relative to the positioning tool 306. In some embodiments, this compressive force may be controlled by one or more actuators of the valve delivery catheter 302. In some cases, the actuation of the positioning tool 306 may be controlled by a handle / system separated from the valve delivery catheter 302. One or more actuators may be configured to apply a controlled tensile force to the positioning tool 306. In some cases, one or more actuators may be configured to lock the positioning tool 306 in a stiffened and bent configuration.

[0044]

[0059] FIG. 3E shows an example of the positioning tool 306 being tracked over the tether 118 until the distal end of the positioning tool 306 is connected to the distal end of the tether 118 in the connection region 128. The positioning tool 306 is inverted and compressed / stiffened into a predetermined shape. Thus, the positioning tool 306 exhibits one or more predetermined bends at 150 (such as a U-shaped bend towards the apex of the heart) and 151 (adjacent to the fixture to the anchor 114). The stiffened positioning tool 306 can further be used to apply tension to the tether 118 (such as by the interaction between the tether 118 and the positioning tool 306 in the connection region) to enable precise control of the movement of the anchor 114.

[0045]

[0060] FIG. 3F shows an example of the use of a stiffened (e.g., compressed) positioning tool 306 to move the anchor 114 from a first position (e.g., 130 in FIG. 3A) to a second position closer to the native valve annulus (e.g., 140 in FIG. 3G). Alternatively or in addition, tension can be applied to the tether 118 to move the anchor 114. In one embodiment, the stiffened and reversed positioning tool 306 can be used to achieve axial alignment of the anchor 114 and the valve delivery catheter 302. The alignment can include positioning the anchor 114 such that it is positioned in a plane perpendicular to the face of the distal end of the valve delivery catheter 302. The stiffened and reversed 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 reversed positioning tool 306 enables the anchor 114 to achieve planar alignment with the valve annulus 145, thereby facilitating ensuring the planar positioning of the valve frame relative to the mitral valve annulus. The positioning tool 306 can also ensure that the anchor 114 maintains a good enclosure of the native biological structures (e.g., chordae tendineae and the apex).

[0046]

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

[0047]

[0062] Figure 3H shows an example of a first portion of the deployment of an artificial valve from the valve delivery member 308 of the coaxial valve delivery catheter 302. The first portion of the deployment can be a partial deployment of the artificial valve. In the embodiment shown in Figure 3H, the outer sheath of the valve delivery catheter 302 is retracted proximally to expose the distal portion of the valve delivery member 308 carrying the artificial valve 310. In some embodiments, the artificial valve 310 self-deploys. When the retaining outer sheath is retracted, the artificial valve 310 can expand to contact the self-valve tip and / or chordae tendineae surrounded by the anchor 114. In some embodiments, the first portion of the artificial valve 310 to be deployed includes the portion within the sub-annular space of the artificial valve 310 or within the second chamber 106 of the heart. In some embodiments, the first portion of the artificial valve 310 to be deployed includes the portion within the supra-annular space of the artificial valve 310 or within the first chamber 104 of the heart.

[0048]

[0063] Figure 3I shows an example of continuing the deployment of the second portion of the artificial valve 310 from the valve delivery member 308. The continued deployment of the artificial valve 310 can include further proximal retraction of the valve delivery member catheter 302. The continued deployment of the artificial valve 310 can include expansion of the remaining portion of the artificial valve 310. In some embodiments, the second portion includes the remaining portion of the artificial valve 310 that was not deployed during the deployment of the first portion. In some embodiments, the second portion of the artificial valve 310 to be deployed includes the portion of the artificial valve 310 within the supra-annular space or within the first chamber 104 of the heart. In some embodiments, the second portion of the artificial valve to be deployed includes the portion of the artificial valve within the sub-annular space or within the second chamber 106 of the heart. The valve 310 can be held in place using a compression fit between the valve 310 and the anchor 114. As shown in Figure 3H, the valve 310 may include one or more flares, such as a ventricular flare and an atrial flare. The artificial valve can include a constriction forming the central portion of the valve 310. The valve 310 may be seated in contact with the anchor 114 such that the anchor surrounds the constricted portion of the valve 310.

[0049]

[0064] The above has described the deployment of the prosthetic valve 310 by retracting the coaxial valve delivery catheter 302 proximally. However, it should be understood that alternative methods of deploying the prosthetic valve 310 are also possible. For example, in some embodiments, the valve delivery member 308 can be advanced distally beyond the mitral valve from its (e.g., initial) position so as to at least partially expose a first portion of the prosthetic valve 310. Alternatively or in addition, the valve delivery catheter 302 can be retracted proximally so as to at least partially expose a second portion of the prosthetic valve. In some embodiments, the first portion is the distal portion of the prosthetic valve 310 and the second portion is the proximal portion. In some embodiments, the first portion is the proximal portion of the prosthetic valve and the second portion is the distal portion.

[0050]

[0065] Furthermore, the above has described the deployment of the valve from a coaxial delivery catheter. However, it should be understood that alternative methods of deploying the prosthetic valve 310 using an inverted tether and / or positioning tool are possible. For example, the valve delivery catheter can include a monorail lumen for the tether. Examples of valve delivery systems that can be used with an inverted tether and / or positioning tool as described herein are described in PCT Application PCT / US2021 / 026463, entitled "VALVE DELIVERY SYSTEM", filed on April 8, 2021, which is hereby incorporated by reference in its entirety.

[0051]

[0066] In some embodiments, the inverted positioning tool 306 and / or the 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. The adjustment of the position may be performed in response to a clinician's evaluation of the self-valve leaflets, chordae tendineae, hemodynamics, and / or the performance of the prosthetic valve. Once the prosthetic valve 310 is fully deployed and positioned, the positioning tool 306 may be retracted, and the tether 118 may be released from and withdrawn from the anchor 114. In some embodiments, the tether 118 is separable from the anchor by a release coupling. Examples of releasable couplings are described in U.S. Patent Application No. 16 / 824,576, which is hereby incorporated by reference in its entirety. The valve delivery catheter 302 and the valve delivery member 308 may likewise be withdrawn and removed. FIG. 3J shows a valve delivery catheter 302 including a valve delivery member 308 that is withdrawn from and removed from the body, leaving the anchor 114 and the prosthetic valve 310 in place.

[0052]

[0067] Figures 4A-4C show an example of a manner of interaction between the proximal end of an anchor and the distal portion of a tether, and the distal end of a positioning tool (such as 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 releasable fitting 408. The fitting may include an adhesive bond, a solder joint, a crimp, or a clamp. In some embodiments, tether 404 and anchor 402 are attached prior to delivery of anchor 402. In some embodiments, the fitting includes at least one end having a selected geometry that is sized and shaped to interact with positioning tool 406. In the examples of FIGS. 4A-4C, fitting 408 includes a wedge having a proximally angled or inclined end 410 shaped to interact or mate (i.e., engage) with the angled or inclined distal end 412 of positioning tool 406. As positioning tool 406 is advanced distally along tether 404, positioning tool 404 ultimately abuts the wedge portion 408 of tether 404. Interaction between wedge portion 408 and positioning tool 406 can result in a rigid interaction with respect to the aligned twist of tether 404 (and attached anchor 402) and 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 as long as the ends interact with each other in a manner that is rigid with respect to twist. For example, the distal end 412 of positioning tool 406 can be a straight cut edge (such as perpendicular to the axis of positioning tool 406 when in a linear configuration).

[0053]

[0068] The positioning tool 406 may include a space, gap or notch (e.g., 414) along one or more distal portions. Under axial compression, the notch facilitates 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 connect to the fixture 408 and the notch 416 presents a narrowed gap under compression. Compression of the positioning tool 406 can cause curvature (e.g., bending or flexing) in one or more portions. The amount of curvature that occurs can depend on the geometry of the notch and / or the amount of compression applied to the positioning tool. The interaction or engagement is an interaction or engagement 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 to the fixture in the tether 404 causes rotation at the distal end of the tether 404 and promotes 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, apex and / or annulus. The positioning tool and tether are further described in PCT / US2021 / 026463, entitled "VALVE DELIVERY SYSTEM", filed Apr. 8, 2021, which is hereby incorporated by reference in its entirety.

[0054]

[0069] Depending on the embodiment, a plurality of bends or flexures may be formed along different circumferential sides or surfaces of the positioning tool on the inverted and stiffened positioning tool. FIG. 5A shows a perspective view of an example of the distal portion of the valve delivery catheter 502 carrying the valve delivery member 508, where the positioning tool 506 extends 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 the artificial valve 510 carried by the valve delivery member 508, exposed by the proximal retraction of the valve delivery catheter 502. For clarity, the tether that the positioning tool follows upward and the anchor for the artificial valve to which the tether is attached are omitted from the drawing. The exemplary positioning tool of FIGS. 5A and 5B has a first bend 514 in the Y-Z plane and a second bend 512 in the X-Y plane when the positioning tool is in the compressed / stiffened state. Depending on the embodiment, the compressed positioning tool includes bends from about 5° to about 310°. The bends of the positioning tool 506 are aligned with and / or can bias the tether to maintain the form (e.g., bends) of the tether that enables the positioning of the valve delivery catheter 502 and the deployment of the artificial valve 510, which is coupled to the anchor. Depending on the embodiment, the compressed positioning tool 506 includes a bend of about 70° to about 100°, such as about 90°, as shown by the bend 512 in FIG. 5A. Depending on the embodiment, the positioning tool 506 includes a bend of about 150° to about 310°, such as about 180°, as shown by the bend 514 in FIG. 5A. Depending on the embodiment, the bends include a radius of curvature from about 2 millimeters (mm) to about 20 mm. Depending on the embodiment, the positioning tool 506 has a substantially straight portion between the first and second bends (e.g., FIG. 5A). The substantially straight portion may have a length from about 10 mm to about 35 mm.

[0055]

[0070] Figures 6A - 6D show a part of the positioning tool 606 having an arrangement configuration of preferentially bendable regions intended to enable inversion of the positioning tool 606. The positioning tool 606 is shown together with a polar coordinate system having a longitudinal axis L, a radial axis R, and an azimuthal axis (e.g., an angular axis) φ. Also, the preferentially bendable regions enable the positioning tool 606 to assume a stiffened configuration in which the anchor in the heart can be positioned during use and to create a curved (bent) portion that can position the valve delivery catheter and provide space for deploying the prosthetic valve. The positioning tool 606 includes an elongated body having an annular wall of generally constant cross-section (e.g., cross-section B - B608 in FIG. 6C) that enables 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, the notches have a varying width (e.g., 626 in FIG. 6A). In some embodiments, the spacing between adjacent notches in the bendable region is generally constant (e.g., 618 in FIG. 6A). In some embodiments, the spacing between adjacent notches in the 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 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 - A610 in FIG. 6B) is spaced from a second bendable region (e.g., cross-section C - C612 in FIG. 6D) along the azimuthal axis of the positioning tool 606. It should be understood that the various shapes, sizes, and arrangements of the notches shown in FIG. 6A are merely illustrative and not all need to be included (e.g., one positioning tool may include only a portion of the variations shown in the positioning tool 606). Also, although the notches have been described above as forming the preferentially bendable regions, those skilled in the art will recognize that several techniques can be used to form preferentially bendable regions in the positioning tool. For example, a braided pattern that reinforces the outer wall of the positioning tool may include regions where the reinforcement is reduced.For example, the positioning tool may include a variable durometer polymeric 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 over the inverted tether 118 without releasing the enclosure of the anchor 114 and follow it. The positioning tool 306 may be configured to axially lift the anchor 114 closer to the face of the self-valve within the sub-valvular space. The positioning tool 306 may be configured to support the anchor 114 in a predetermined position without affecting the deployment of the prosthetic valve 310. The positioning tool 306 may be configured to force the anchor 114 to follow (e.g., coaxially) through the valve delivery catheter 302.

[0057]

[0072] FIG. 10A shows an exemplary positioning tool 1006 positioned on 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 Y-Z plane), and the second preferentially bendable region 1046 can be configured to bend along a second plane different from the first plane (e.g., the X-Y 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., positioned toward the apex of the heart). The second preferentially bendable region 1046 can be positioned closer to the distal end 1050 of the positioning tool 1006 compared to the first preferentially bendable region 1044 and can be configured to bend radially inwardly 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 these portions to preferentially bend from a linear 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 to a stiffened state. This shape can allow the positioning tool 1006 to support and / or push the anchor toward the native valve annulus. One side of the second preferentially bendable region 1046 can include a notch configured to bend the positioning tool 1006 a predetermined angle radially inwardly.

[0058]

[0073] The positioning tool 1006 may have a first section 1030 and a second section 1040. The first section 1030 is between the anchor surface 1032 and the surface 1034 where the curvature of the first preferential bendable region 1044 begins. The second section 1040 is between the surface 1034 and where the curvature of the second preferential bendable region 1046 begins. The second section 1040 may be substantially 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 the prosthetic valve) during deployment of the prosthetic valve and to provide space for deployment of the prosthetic valve. In some embodiments, the length L1 is in the range between any two of the values 15 mm, 20 mm, 25 mm, 30 mm, and 40 mm.

[0059]

[0074] FIG. 10B shows an enlarged view of the distal portion of the positioning tool 1006. As shown in the figure, the distal end 1050 may include an inclined edge that can interact with or engage a corresponding inclined edge of a portion of the tether and / or the anchor (e.g., the fixture 408). FIG. 10B shows a circumferential notch 1054 on one side of the second selectable bendable region 1046 to enable bending to a predetermined shape (e.g., the arcuate second preferential bendable region 1046 as shown in FIG. 10A) when an axial compressive force is applied to the positioning tool 1006. For example, the second preferential bendable region 1046 can be configured to bend towards the notch 1054 such that the gap formed by the notch 1054 narrows. Although not shown in FIG. 10B, the first preferential bendable region 1044 may also include a circumferential notch that forms the predetermined U-shape shown in FIG. 10A.

[0060]

[0075] As shown in FIG. 10B, the second section 1040 of the positioning tool 1006 may also include a notch 1066. The pattern of the notch 1066 is configured to allow the second section 1040 to bend / kink laterally when the second section 1040 follows on the tether, but to remain straight when an axial compressive force is applied to the positioning tool 1006. In some embodiments, the notch 1066 is arranged in a helical pattern around the outer periphery of the positioning tool 1006. In some cases, the first section 1030 includes a notch 1066 that is the same or similar to allow the first section 1030 to remain straight when an axial compressive force is applied to the positioning tool 1006, but to bend / kink when following on the tether.

[0061]

[0076] FIGS. 11A and 11B show another exemplary positioning tool 1106 having features similar 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 ensure that the anchor 1114 is easily held at a height sufficient to provide space for the artificial valve deployment. In some embodiments, the length L2 ranges between any two of the values 25 mm, 30 mm, 35 mm, 40 mm, 45 mm, and 50 mm.

[0062]

[0077] When compared with the positioning tool 1006 of FIGS. 10A and 10B, the second section 1140 can be non-parallel to the first section 1130. This angled configuration can provide a larger space for the deployment of an artificial valve (e.g., the frame portion of an artificial valve). For example, this configuration can place the distal end 1150 and the second preferential bendable region 1146 further away from the first section 1130, thereby reducing the possibility that the distal end 1150 and / or the second preferential bendable region 1146 interfere with the artificial valve and cause displacement of the artificial valve during deployment.

[0063]

[0078] As shown in FIG. 11B, the distal end 1150 of the positioning tool 1006 can have a straight (e.g., non-inclined) edge. This straight configuration can prevent the distal end from cutting into the tether. Further, the distal section 1159 of the positioning tool 1106 can include a distal section 1159 that is distal to the second preferential bendable region 1146. The distal section 1159 can provide a larger margin for the deployment of the artificial valve. The distal section 1159 can include a notch 1166 configured to allow the distal section 1159 to bend / flex when the distal section 1159 is made to follow on the tether, while remaining straight when an axial compression force is applied to the positioning tool 1106. In some embodiments, the notch 1166 is arranged in a spiral pattern around the outer periphery of the positioning tool 1106. In some cases, the first section 1130 and / or the second section 1140 also include notches 1166 that are the same or similar to the notch 1166, such that the first section 1130 and / or the second section 1140 can bend / flex while following on the tether, while remaining straight when an axial compression force is applied to the positioning tool 1106.

[0064]

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

[0065]

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

[0066]

[0081] FIG. 8 is a flowchart 800 showing a method of following along a tether to deploy an artificial valve in a valve delivery catheter. Exemplary operation 802 includes following along the tether to a first chamber of the heart with a delivery device, the tether being coupled to an anchor near the native valve annulus of the heart. Exemplary operation 804 includes following along the tether to a second chamber of the heart with the delivery device to position an artificial valve capsule that is carried beyond the native valve annulus by the delivery device. Exemplary operation 806 includes exposing the artificial valve for deployment within the native valve annulus.

[0067]

[0082] FIG. 9 is a flowchart 900 showing a method of coaxially following along a tether in a valve delivery catheter to deploy an artificial valve. Exemplary operation 902 includes moving a portion of the tether into a patient's chamber (e.g., ventricle) through an anchor to which the tether is attached. Exemplary operation 904 includes deploying a positioning tool along the tether toward the anchor or a fixture attached to the proximal end of the tether and / or the anchor. Next, the distal edge of the positioning tool can engage the proximal edge of the anchor or the proximal edge of a fixture attached to the proximal end of the tether and / or the anchor. Exemplary operation 906 includes stiffening the positioning tool and / or applying tension to the tether. In some cases, the positioning tool assumes a curved shape when compressed / stiffened. For example, the positioning tool may exhibit a U-shaped bend under the valve annulus relative to the anchor such that the distal end of the positioning tool is directed toward the anchor. The distal end of the positioning tool can include an engagement surface configured to engage or couple directly or indirectly to the proximal end of the anchor. In this way, the stiffened positioning tool can engage the anchor to control movement of the anchor. In some cases, the positioning tool includes a second bend that bends radially inward near the distal end of the positioning tool to correspond to the geometry of the anchor.

[0068]

[0083] The exemplary 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 a tether. For example, it may be desirable for the anchor to be as close as possible to the annulus of the native valve. In some cases, the anchor may be adjusted upward toward the annulus of the native valve. The exemplary operation 910 includes coaxially tracking the tether through the patient's anatomy and over the face of the native valve to the valve capsule. The exemplary operation 912 includes deploying the prosthetic valve from the valve capsule into the anchor. It should be understood that although the above is shown as a series of operations, one or more of the operations may be performed in a different order. For example, in some embodiments, stiffening the positioning tool and / or applying tension to the tether may be performed after tracking the valve delivery catheter over the native valve of the heart. For example, in some embodiments, deployment of the positioning tool may be performed after tracking the valve delivery catheter over the native valve of the heart.

[0069]

[0084] FIG. 12 is a flowchart 1200 showing a method of delivering a prosthetic valve that includes inverting a tether to track the prosthetic valve. The exemplary operation 1202 includes engaging an anchor to the chordae tendineae of the diseased native valve. Deployment of the anchor may be performed using an anchor delivery device or system that may include an anchor delivery catheter (also referred to as a steerable catheter or outer sheath) configured to bend and extend to maneuver the anchor to the proper position. In some cases, the anchor delivery device or system may further include an anchor guide translatable within the steerable catheter. The anchor guide may include an internal lumen for housing the anchor therein. The anchor guide may be capable of assuming a curved shape upon deployment of the anchor from the anchor guide. In some embodiments, the anchor includes a wire that, when deployed, wraps around a central axis and has a planar shape. The anchor may be deployable such that the wrap surrounds the chordae tendineae of the native valve. The proximal end of the anchor may 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 self-valve and positioned in an inverted configuration. In some embodiments, this is done using a steerable catheter of the anchor delivery device or system. For example, while the steerable catheter is still being made to follow over the tether (e.g., after the deployment of the anchor), the steerable catheter can be advanced through the valve annulus and the face of the anchor. This advancement of the steerable catheter can translate a portion of the tether from a first chamber (e.g., atrium) of the heart to a second chamber (e.g., ventricle) of the heart. In some cases, positioning the tether in an inverted configuration includes causing the tether to exhibit a U-shaped bend. In some cases, positioning the tether in an inverted configuration includes translating the tether relatively distally with respect to the steerable catheter to provide additional tether length within the second chamber.

[0071]

[0086] Once the tether is in an inverted configuration, in operation 1206, the valve delivery device can be made to follow over the tether. Making the valve delivery device follow over the tether can include advancing the valve delivery device over the tether through the valve annulus of the self-valve. The valve delivery device can include a positioning tool that can be used to adjust the axial height of the anchor relative to the self-valve annulus (see, e.g., FIG. 9). The positioning tool may be configured to transition from a linear configuration (e.g., for passing through the patient's blood vessel within the valve delivery device) to a predetermined curved shape (e.g., U-shaped). In operation 1208, the prosthetic valve can be released from the valve delivery device into the self-valve annulus and within the anchor. Due to the counterforce between the prosthetic valve and the anchor, the prosthetic valve can be fixed in a predetermined position within the valve annulus of the self-valve. Once the prosthetic valve is fully deployed, the valve delivery device and the tether can be removed from the heart and the patient's body.

[0072]

[0087] The artificial valve may be similar to that of an existing trans-catheter delivery valve. The artificial valve may be similar to existing surgical bioprosthetic valves and mechanical valves. At least a portion of the valve compartment may be located within at least a portion of an artificial valve, for example, an artificial valve having a frame structure of the artificial valve. The valve compartment may include an apex formed of a multi-layer material for selective function. The valve compartment may include at least one apex having an inner layer and an outer layer. The valve compartment may be directly attached to the artificial valve. Alternatively, the valve compartment may be attached to an intermediate valve structure that is connected to the artificial valve. The valve compartment may be connected to the artificial valve before or after the artificial valve is disposed adjacent to the native valve. The artificial valve may be attached to the apex of the valve compartment, for example, the outer layer of the apex, at one or more ends of the artificial valve. The artificial valve may be attached to the apex of the valve compartment, for example, the outer layer of the apex, at one or more intermediate portions of the artificial valve. The valve compartment may include a plurality of apices. The valve compartment may include a biocompatible one-way valve. The one-way flow can deflect the apex to open, and the flow in the opposite direction can close the apex.

[0073]

[0088] The frame structure can be configured like a stent. The frame structure may include, for example, a diamond pattern backbone formed from a shape memory material (such as nitinol NiTi). Those skilled in the art will recognize that many other structures, materials, and configurations are also available for the frame structure. For example, the frame structure may be formed from a polymer with sufficient elasticity. The frame structure may be formed from a combination of metal and polymer, such as a metal (such as a shape memory material) coated with a polymer. The frame structure may include various patterns other than the diamond shape. In some embodiments, the frame structure is a closed frame such that blood flow is forced to flow into it through the valve compartment. One or more skirts and / or sealing materials may help to force blood through the valve compartment.

[0074]

[0089] Based on the description in this specification, those skilled in the art will understand that any of the prosthetic valves described herein may include any one of the shape of the frame structure, the design of the frame structure, the material of the frame structure, the shape of the anchor, the winding of the anchor, the material of the anchor, the free tip, the apical configuration, or any other feature of the variable features described herein, or any combination thereof as necessary.

[0075]

[0090] Example 1

[0091] Figures 13A - 13C show fluoroscopic images of an exemplary tether inversion procedure performed within a calf's heart. Figure 13A shows an anchor 114 positioned around a chordae tendineae (as in, for example, Figure 2B) and attached to a tether 118 coming from the outer sheath 108. Figure 13B shows the outer sheath 108 advanced towards the left valve leaflet. As shown in the figure, there is a slack 122 portion of the tether 118 above the anchor 114, and the tether 118 may assume a constrained / twisted configuration due to tension (as in, for example, Figure 2F). Figure 13C shows the inverted configuration of the tether 118 after partially retracting within the outer sheath 108 such that the slack 122 is removed and the tether 118 can unwind into a U - shaped configuration under the valve annulus relative to the anchor 114.

[0076]

[0092] Example 2

[0093] Figures 14A - 14C show fluoroscopic images of an exemplary positioning tool 1006 used to control the axial height of an anchor 114 within the heart. These images are positioned around the chordae tendineae and show the anchor attached to the tether, with the positioning tool 1006 being advanced from the valve delivery catheter 302 above the tether. The positioning tool 1006 is shown in a stiffened, curved state. Figure 14A shows the positioning tool 1006 supporting the anchor 114 at a first axial height relative to the native annulus 145. In Figure 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 Figure 14C, the positioning tool 1006 is pulled proximally in the stiffened / flexed 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] Figures 15A and 15B show fluoroscopic images of an example deployment of an artificial valve 310 in the heart, illustrating a potential problem associated with the length of the positioning tool 1506. As described above, the length of the positioning tool 1506 (e.g., L1 or L2) needs to be long enough so as not to interfere with the deployment of the artificial valve 310. Figure 15A shows the positioning tool 1506 supporting the anchor 114 near the annulus prior to deployment of the artificial valve 310 from the valve delivery catheter 302. Figure 15B shows the artificial 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 the deployment of the artificial valve 310. As described above, the length of the positioning tool 1506 can be selected to be long enough to provide sufficient space for artificial valve deployment.

[0078]

[0096] As used herein, when a mechanism or element is said to be "above" another mechanism or element, it can be directly above that other mechanism or element, or intervening mechanisms and / or elements may also be present. In contrast, when a mechanism or element is said to be "directly above" another mechanism or element, no intervening mechanism or element is present. Also, when a mechanism or element is said to be "connected to", "attached to", or "coupled to" another mechanism or element, it should be understood that it can be directly connected, attached, or coupled to that other mechanism or element, or intervening mechanisms or elements may be present. In contrast, when a mechanism or element is said to be "directly connected to", "directly attached to", or "directly coupled to", no intervening mechanism or element is present. Although described and illustrated in connection with one embodiment, the mechanisms and elements so described or illustrated are also applicable to other embodiments. Also, it will be understood by those skilled in the art that a structure or mechanism said to be "adjacent to" another mechanism may have portions that overlap or are below that adjacent mechanism.

[0079]

[0097] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. For example, the singular forms "a", "an", and "the" used herein are intended to include the plural forms as well, unless the context clearly dictates otherwise. Further, when the terms "comprising" and / or "including" are used herein, they specify the presence of the recited mechanisms, steps, acts, elements, and / or components, but do not preclude the presence or addition of one or more other mechanisms, steps, acts, elements, components, and / or groups thereof. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items and may be abbreviated as " / ".

[0080]

[0098] In this specification, spatial relative terms such as "lower", "below", "bottom", "upper", "above", etc. may be used for ease of description to explain the relationship of one element or mechanism to another element or mechanism as illustrated in the drawings. It should be understood that these spatial relative terms are intended to encompass different orientations of the device during use or operation in addition to the orientation shown in the drawings. For example, if the device in the figure is inverted, an element described as being "lower" or "below" another element or mechanism will be in the "upper" orientation of that other element or mechanism. Thus, the exemplary term "lower" can encompass both upward and downward orientations. The device may be in other orientations (such as a 90-degree rotation or other orientations), and the spatial relative descriptive terms used in this specification shall be interpreted accordingly. Similarly, terms such as "upward", "downward", "vertical", "horizontal", etc. are used for illustrative purposes in this specification unless specifically indicated otherwise.

[0081]

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

[0082]

[0100] Throughout this specification and the following claims, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", are meant to imply that various components are adoptable together in a method and things (e.g., compositions and devices including devices and methods). For example, the term "comprising" is understood to imply the inclusion of any described element or step, but not the exclusion of other elements or steps.

[0083]

[0101] Unless otherwise defined, all numerical values used in this specification and the claims are to be read as if prefaced by the terms "about" or "approximately," even if such terms are not explicitly stated, including those used in the examples. The terms "about" or "approximately" may be used when describing a magnitude and / or position to indicate that the recited value and / or position are within a reasonable expected range. For example, a numerical value may have a value that is + / - 0.1% of the recited value (or range of values), + / - 1% of the recited value (or range of values), + / - 2% of the recited value (or range of values), + / - 5% of the recited value (or range of values), or + / - 10% of the recited value (or range of values). Any numerical value disclosed herein is also to be construed as including its about or approximate value, unless the context indicates otherwise. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any range disclosed herein is intended to include all sub-ranges subsumed therein. It is also to be understood that when a value is disclosed, the values "less than" that value, "greater than or equal to" that value, and the possible ranges between the values are also disclosed, as would be appropriately understood by a person skilled in the art. For example, if the value "X" is disclosed, "less than X" and "greater than or equal to X" (e.g., if X is a numerical value) are also disclosed. Also, throughout this application, it is to be understood that the data is presented in several different formats and that these data represent ranges between endpoints and any combination of these data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, 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 to be considered disclosed as values between 10 and 15. It is also to be understood that each unit amount between two particular unit amounts is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0084]

[0102] Although various exemplary embodiments have been described above, many variations of any of the various embodiments can be added without departing from the scope of the invention as described by the claims. For example, the order in which the various method steps are performed can often be changed in alternative embodiments, and in other alternative embodiments, one or more method steps may be completely skipped. Optional features of the various device and system embodiments may or may not be included in some embodiments. Accordingly, the above 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 included in this specification are for illustrative purposes and not for purposes of limitation, and show specific embodiments in which the subject matter may be practiced. As described above, other embodiments can be used and derived in such a way that structural and logical alternatives and modifications are added without departing from the scope of the present disclosure. Such embodiments of the subject matter of the present invention are herein referred to simply for convenience as "the invention," individually or collectively, without intending to spontaneously limit the scope of this application to any single invention or inventive concept, as actually multiple inventions may be disclosed. Accordingly, although specific embodiments have been illustrated and described herein, any configuration intended to achieve the same purpose can be used in place of the specific embodiments shown. The present disclosure is intended to cover any modifications or variations of the various embodiments. Upon review of the above description, those skilled in the art will become apparent as to the combinations of the above embodiments and other embodiments not specifically described herein. The present invention includes the following aspects. 1. A method for treating a diseased native valve in a patient, comprising: surrounding a chord of the diseased native valve with an anchor to which a string is attached; translating a part of the string from a first chamber of the heart through an annulus of the diseased native valve to a second chamber of the heart with the anchor positioned around the chord, the translation of the string forming a bend in the string within the second chamber; tracking the string with a valve delivery device; and releasing an artificial valve from the valve delivery device into the annulus of the diseased native valve and within the anchor. 2. The method according to 1., further comprising: delivering the anchor to the diseased native valve by an anchor delivery device including a steerable catheter. 3. The method according to 2., wherein the step of translating the part of the string through the annulus of the diseased native valve comprises: advancing the steerable catheter towards a face of the anchor; advancing the string while maintaining the attachment of the string to the anchor to create a slack in the string that is at least partially coiled within the first chamber; and advancing the steerable catheter beyond the face of the anchor to position at least a part of the string within the second atrium. 4. The method according to 3., wherein the step of advancing the steerable catheter includes advancing the steerable catheter to a position close to the apex of the second chamber. 5. The method according to 3., further comprising the step of retracting the anchor delivery device from the diseased native valve. 6. The method according to 2., wherein the anchor delivery device further comprises an anchor guide configured to translate within the steerable catheter, the anchor guide including an internal lumen for receiving the anchor. 7. The method according to 6., wherein the anchor guide assumes a curved shape upon deployment of the anchor from the anchor guide. 8. The method according to 1., wherein the cord exhibits a substantially U-shaped bend within the second chamber when in a bent configuration. 9. The method according to 8., wherein the step of positioning the cord in the bent configuration includes translating the cord distally relative to the steerable catheter so as to provide an extended cord length within the second chamber. 10. The method according to 1., wherein the step of following the cord onto the valve delivery device includes advancing a valve delivery catheter through the annulus of the diseased native valve. 11. The method according to 1., wherein the step of following the cord onto the valve delivery device includes deploying a positioning tool onto the bent cord. 12. The method according to 11., further comprising advancing the positioning tool distally until the distal end of the positioning tool is connected to a fixture attached to the proximal end of the anchor. 13. The method according to 11., further comprising applying a compressive force along the positioning tool so as to stiffen the positioning tool. 14. The method according to 13., wherein the step of applying the compressive force includes pulling the cord proximally so as to apply tension to the cord. 15. The method according to 14., wherein the step of pulling the cord proximally so as to apply tension to the cord includes using a handle to apply a controlled amount of tension to the cord. 16. The method according to 13., wherein the step of applying the compressive force causes the positioning tool to assume a substantially U-shaped bend under the annulus of the anchor. 17. The method according to 16., further comprising the step of releasably attaching the distal end of the positioning tool to the anchor. 18. The method according to 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 according to 18., wherein the step of adjusting the position of the anchor includes the step of pulling the positioning tool proximally to move the anchor towards the valve annulus of the diseased valve. 20. The method according to 18., wherein the position of the anchor is adjusted such that it is closer to the valve annulus of the diseased native valve. 21. The method according to 18., wherein the position of the anchor is adjusted such that the anchor is located in a plane perpendicular to the plane of the distal end of the valve delivery device. 22. The method according to 1., wherein the step of bending the string in the second chamber includes the step of inverting the string in the second chamber. 23. The method according to 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 an artificial valve to a diseased valve of the heart, a string configured to connect to a valve anchor and further configured to extend from a position external to the heart through at least the first chamber of the heart into the second chamber of the heart, a valve delivery catheter configured to extend on the string into the second chamber, holding the artificial valve therein and configured to release the artificial valve into the valve anchor with the string connected to the valve anchor, comprising. 25. The delivery system according to 24., wherein the string is configured to assume a substantially U-shape in the second chamber of the heart. 26. The delivery system according to 24., wherein the string is releasably attached to the valve anchor. 27. The delivery system according to 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 according to 24., wherein the valve anchor has a spiral shape, and the valve delivery catheter is configured to extend through a central opening of the valve anchor so as to align the artificial valve before release of the artificial valve. 29. The delivery system according to 28., wherein the valve delivery catheter is configured to axially align the central portion of the artificial valve with the diseased valve. 30. The system according to 24., wherein a distal end of the valve delivery catheter includes a nose cone having a port sized and shaped to pass the wire therethrough, the port having a central axis coaxial with a central axis of the valve delivery catheter. 31. The delivery system according to 24., further comprising a positioning tool configured to pass through the valve delivery catheter and extend onto the wire, the positioning tool being connected to the valve anchor and configured to control a position of the valve anchor after the valve anchor is deployed within the heart. 32. The delivery system according to 31., wherein the positioning tool includes one or more regions configured to bend into a predetermined shape. 33. The delivery system according to 32., wherein the region has a relatively reduced bending stiffness. 34. The delivery system according to 32., wherein the one or more regions include one or more notches configured to enable the region to bend into the predetermined shape when a compressive force is applied to the positioning tool. 35. The delivery system according to 32., wherein the one or more regions are configured to bend into the predetermined shape when tension is applied to the wire therein. 36. The delivery system according to 32., wherein a first region is configured to transition from a linear shape to a U-shaped configuration. 37. The delivery system according to 36., wherein a second region is configured to transition from a linear shape to a curved shape that bends radially inwardly toward a center of the valve anchor. 38. The delivery system according to 32., wherein the positioning tool includes a distal edge configured to engage with the proximal edge of the valve anchor or the proximal edge of a fixture attached to the proximal end of the valve anchor. 39. The delivery system according to 38., wherein the distal edge of the positioning tool is inclined, and is configured to engage with an inclined edge corresponding to the inclined distal edge at the proximal edge of the valve anchor, or the proximal edge of a fixture attached to the proximal end of the valve anchor. 40. The delivery system according to 24., further comprising an anchor delivery device configured to deploy the valve anchor into the heart prior to delivery of the artificial valve by the valve delivery catheter. 41. The delivery system according to 40., wherein the anchor delivery catheter includes a steerable catheter having a distal end configured to bend to position the valve anchor within the heart. 42. The delivery system according to 41., wherein the anchor delivery catheter is configured to extend over the wire. 43. The delivery system according to 40., wherein the anchor delivery device includes a steerable catheter configured to position a portion of the wire from the first chamber of the heart into the second chamber of the heart. 44. The delivery system according to 43., wherein the steerable catheter is configured to dispose the wire in an inverted configuration within the second chamber of the heart. 45. The delivery system according to 43., wherein the steerable catheter is configured to form a U-shaped portion of the wire within the second chamber of the heart. 46. The delivery system according to 43., wherein the anchor delivery catheter is configured to extend through a central opening of the valve anchor. 47. The delivery system according to 24., wherein the valve delivery catheter includes an inner shaft and an outer sheath, and the artificial valve is compressed between the inner shaft and the outer sheath. 48. The delivery system according to 47, wherein the inner shaft is configured to accommodate a positioning tool, and the positioning tool is configured to adjust the position of the valve anchor when the valve anchor is wound around the chordae tendineae of the diseased valve. 49. The delivery system according to 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 according to 47, wherein retraction of the valve delivery catheter proximally is configured to be retracted proximally to expand the prosthetic valve. 51. A delivery system for delivering a prosthetic valve to a diseased valve of a heart, a cord configured to be connected to a valve anchor surrounding at least a portion of the chordae tendineae of the diseased valve, and further configured to extend from a position outside the heart through at least a first chamber of the heart into a second chamber of the heart, and 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 along the cord and connect to a proximal portion of the valve anchor, wherein the positioning tool includes one or more regions configured to bend to dispose the positioning tool in a predetermined shape when an axial compressive force is applied to the positioning tool. 52. The delivery system according to 51, wherein the predetermined shape includes an inversion portion configured to be positioned subannularly relative to the valve anchor within the second chamber of the heart. 53. The delivery system according to 51, wherein the predetermined shape includes a substantially U-shaped bend. 54. The delivery system according to 51, wherein the one or more regions include one or more notches along a portion around the elongated body, and a width gap of the one or more notches decreases upon compression of the positioning tool. 55. The delivery system according to 51, 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 the center of the valve anchor. 56. The delivery system according to 51, further comprising a valve delivery catheter configured to house the positioning tool therein, wherein the positioning tool translates within the valve delivery catheter and is configured to extend from a distal end of the valve delivery catheter. 57. The delivery system according to 56, wherein the valve delivery catheter further houses the prosthetic valve therein. 58. The delivery system according to 56, wherein the valve delivery catheter includes an inner shaft within a central opening of the prosthetic valve, and the inner shaft is configured to house the positioning tool therein. 59. The delivery system according to 55, wherein the prosthetic valve expands upon retraction of the valve delivery catheter proximally. 60. The delivery system according to 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 to move the valve anchor toward the surface of the diseased valve. 61. The delivery system according to 51, wherein the positioning tool is configured to bend and stiffen when the wire is pulled proximally. 62. The delivery system according to 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, deploying an anchor from an anchor delivery catheter such that the anchor surrounds a chord of the diseased native valve, wherein after the anchor is deployed, a wire 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, wherein the distal end of the anchor delivery catheter is translated through a central opening of the deployed anchor; advancing the wire through the anchor delivery catheter until a loop of the wire is disposed within the second chamber of the heart; A step of retracting the string within the anchor delivery catheter until slack in the string is removed, the retracting step including releasing the tension applied to the string and causing the string to assume an inverted configuration within the second chamber of the heart. 64. The method according to 63, further comprising the step of retracting the anchor delivery catheter from the heart. 65. The method according to 64, further comprising the step of causing a valve delivery catheter containing an artificial valve to follow over the string. 66. The method according to 65, wherein the step of causing the valve delivery catheter to follow 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 according to 66, wherein the positioning tool is advanced until the distal end of the positioning tool engages a fitting attached to the proximal end of the anchor. 68. The method according to 67, further comprising the step of adjusting the position of the deployed anchor by translating the positioning tool with which the anchor is engaged. 69. The method according to 68, wherein the step of adjusting the position of the deployed anchor includes the step of moving the anchor closer to the annulus surface of the diseased valve. 70. The method according to 65, further comprising the step of releasing the artificial 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 according to 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 according to 63, wherein the step of deploying the anchor from the anchor delivery catheter includes deploying the anchor from the distal end of an anchor guide positioned within the anchor delivery catheter. 73. The method according to 72, further comprising the step of translating the anchor guide distally relative to the anchor delivery catheter. 74. The method according to 72., further comprising the step of causing the anchor guide to have a curved shape configured to facilitate deployment of the anchor around the chordae tendineae. 75. The method according to 63., further comprising the step of bending the anchor delivery catheter to manipulate the distal end of the anchor delivery catheter through the central opening of the anchor. 76. A delivery system for delivering an artificial valve to an affected valve, an outer sheath, [[ID=,4]]a hollow inner shaft defining a wire lumen extending therethrough and configured to receive a wire, a delivery catheter including a nose cone including a port axially aligned with the wire lumen and configured to receive the wire at a distal end, the nose cone being reversibly coupled to the distal end of the delivery catheter and extending therefrom and being formed to hold the artificial valve within the delivery catheter. 77. The delivery system according to 76., wherein the wire lumen is positioned coaxially with the outer sheath. 78. The delivery system according to 76., wherein the port is positioned coaxially with the outer sheath when the nose cone is coupled to the delivery catheter. 79. The delivery system according to 76., further comprising an elongate positioning tool, the positioning tool tracking over the wire through the wire lumen and through the port to the distal end of the wire, adjusting the orientation of the valve anchor relative to the patient's anatomy configured as such. 80. The delivery system according to 79., wherein the elongate positioning tool includes at least two regions that are preferentially bendable for adjusting the orientation of the valve anchor. 81. The delivery system according to 80., wherein the adjustment 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 according to 81., wherein the first predetermined bend or the second predetermined bend includes an angle of about 120 degrees to about 310 degrees. 83. The delivery system according to 82, wherein the first predetermined bent portion or the second predetermined bent portion includes an angle of about 70 degrees to about 100 degrees. 84. The delivery system according to 82, wherein the first predetermined bent portion or the second predetermined bent portion includes a radius of curvature of about 2 millimeters (mm) to about 20 mm. 85. The delivery system according to 81, wherein the at least two regions have a reduced compressive stiffness relative to the rest of the positioning tool. 86. The delivery system according to 82, wherein the at least two regions are formed to bend when a compressive force is applied to the positioning tool along the longitudinal axis. 87. The delivery system according to 80, wherein a first region of the at least two regions is spaced apart from a second region along the longitudinal axis of the positioning tool. 88. The delivery system according to 80, wherein a first region of the two regions is spaced apart from a second region along the azimuth axis of the positioning tool. 89. The delivery system according to 80, wherein when the positioning tool is extended to the distal portion of the wire, the at least two regions are located distally with respect to the distal end of the delivery catheter. 90. The delivery system according to 80, wherein the at least two regions include a plurality of notches in the outer wall of the positioning tool. 91. The delivery system according to 79, wherein the distal end of the positioning tool is sized and shaped to interact with the distal portion of the wire. 92. The delivery system according to 91, wherein the distal end of the positioning tool is sized and shaped to be capable of interacting with the proximal end of the distal portion of the wire. 93. The delivery system according to 91, wherein the distal end of the positioning tool includes an inclined portion, and the inclined portion is sized and shaped to interact with a corresponding inclined portion at the proximal end of the distal portion of the wire. 94. The delivery system according to 76, further comprising a valve delivery member, wherein the valve delivery member (a) 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) shaped and sized and configured to carry the prosthetic valve, and A delivery system having an inner shaft defining a valve delivery member lumen configured to receive the wire. 95. The delivery system according to 94., wherein the valve delivery member includes the nose cone and the port is the distal end of the valve delivery member lumen. 96. A delivery system for delivering a prosthetic valve to an affected valve, An outer shaft, A valve delivery member at the distal end of the outer sheath, A hollow inner shaft positioned within the outer shaft and the valve delivery member, coaxial with the outer shaft and configured to pass a wire therethrough. 97. A delivery system for delivering a prosthetic valve to an affected valve, An outer sheath defining a valve lumen sized to carry the prosthetic valve in a folded state, An inner shaft passing through the outer sheath and extending along the central axis of the outer sheath, the inner shaft defining a wire lumen configured to receive a wire, Including a delivery catheter, A nose cone including a port coaxial with the wire lumen at the distal end, the nose cone being connectable to the distal end of the delivery catheter to hold the prosthetic valve within the delivery catheter. The delivery catheter and the nose cone are separable for deployment of the prosthetic valve, the deployment including translation of the wire lumen and / or the port relative to the wire. 98. The delivery system according to 97., wherein the wire lumen is positioned along the central axis of the delivery catheter. 99. The delivery system according to 97., wherein the inner shaft is coaxial with the outer sheath. 100. The delivery system according to 97., wherein the port is disposed at the center of the distal end of the nose cone. 101. The delivery system according to 97., wherein the wire lumen and / or the port are configured to translate relative to the wire while the wire is maintained in a substantially fixed position. 102. The delivery system according to 101., further comprising a positioning tool having an elongated body with a proximal end for extending to the proximal portion of the delivery catheter and a distal end for extending to the distal portion of the wire, wherein the positioning tool translates along the wire through the lumen of the wire and through the port, and is configured to couple to the distal portion of the wire to maintain the wire in a substantially fixed position. 103. The delivery system according to 97., wherein the wire lumen is configured to translate proximally relative to the wire for the deployment of the prosthetic valve. 104. The delivery system according to 97., wherein the port is configured to translate distally relative to the wire for the deployment of the prosthetic valve. 105. The delivery system according to 97., further comprising a valve delivery member, the valve delivery member (a) includes an elongated body having an outer wall with a shape and size 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. The delivery system having an inner shaft coaxial with the outer wall and defining a valve delivery lumen extending therethrough, the valve delivery lumen being configured to receive the wire. 106. The delivery system according to 105., wherein the valve delivery member includes the nose cone and the port forms the distal end of the valve delivery member lumen. 107. The delivery system according to 105., wherein the prosthetic valve is configured to expand to an expanded state upon deployment of the prosthetic valve. 108. A method for treating a diseased native valve in a patient, tracking the wire coupled to the anchor near the native valve annulus of the heart to the first chamber of the heart with a delivery device; further tracking the delivery device along the wire into the second chamber of the heart to position the valve capsule carried by the delivery device beyond the native valve annulus; exposing the valve capsule to deploy the prosthetic valve. 109. The method according to 108., further comprising advancing the wire to the second chamber while maintaining the connection with the anchor. 110. The method according to 108., wherein the step of advancing the string further includes the step of forming a first bend and a second bend in the string in the second chamber. 111. The method according to 110., wherein one of the first bend and the second bend includes an angle of from about 120 degrees to about 310 degrees. 112. The method according to 110., wherein the step of advancing the string is 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 according to 110., wherein the step of advancing the string includes advancing the string through the inner diameter of the anchor. 114. The method according to 110., wherein the step of advancing is such that most of the string extending from the delivery device is under the valve annulus. 115. The method according to 108., further comprising the step of initially moving the anchor from a first position to a second position. 116. The method according to 115., wherein the step of moving the anchor is between the step of following the delivery device into the second chamber and the step of exposing the valve capsule. 117. The method according to 115., further comprising the step of following the positioning tool over the string such that the distal end of the positioning tool is positioned near the junction of the string and the anchor. 118. The method according to 117., wherein the distal end of the positioning tool is connected to the distal end of the string. 119. The method according to 118., wherein the step of moving the anchor includes compressing at least a portion of the positioning tool and / or applying tension to the string. 120. The method according to 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 such that at least a portion of the anchor is substantially parallel to the valve annulus surface of the self-valve. 121. The method according to 115., wherein the second position is closer to the self-valve annulus than the first position. 122. The method according to 118., wherein the step of causing the delivery device to follow to the first room includes the step of inserting the proximal end of the wire into a port located at the distal end of the delivery device. 123. The method according to 122., wherein the port is coaxially located with the outer sheath of the delivery device. 124. A method for treating a diseased native valve in a patient, a step of coaxially following along a wire to the first chamber of the heart with a delivery device carrying an artificial valve, wherein the distal end of the wire is coupled to an anchor near the native valve annulus of the heart; a step of further coaxially following the delivery device up the wire to the second chamber of the heart to position the artificial valve beyond the native valve annulus; and a step of exposing the artificial valve to deploy the artificial valve. 125. The method according to 124., wherein the step of coaxially following is through a port of a nose cone coupled to the distal end of the delivery device. 126. The method according to 124., wherein the step of coaxially following is through the lumen of a valve delivery member carrying the artificial valve within the delivery device. 127. The method according to 124., wherein during the step of coaxially following, the proximal end of the wire extends from the portion of the delivery device outside 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. The delivery system according to claim 9, wherein the region has a relatively reduced bending stiffness, the delivery system.

11. The delivery system according to claim 9, wherein the one or more regions are configured to bend into the predetermined shape when a compressive force is applied to the positioning tool, the delivery system including one or more notches.

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

13. The delivery system according to claim 9, wherein a first region is configured to transition from a linear shape to a U-shaped shape, the delivery system.

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

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

16. The delivery system according to claim 15, wherein the distal edge of the positioning tool is inclined and is configured to engage an inclined edge corresponding to the inclined distal edge at the proximal edge of the valve anchor or the proximal edge of a fixture attached to the proximal end of the valve anchor, the delivery system.

17. The delivery system according to claim 1, further including an anchor delivery device configured to deploy the valve anchor into the heart prior to delivery of the prosthetic valve by the valve delivery catheter, the delivery system.

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

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

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

21. The delivery system according to claim 20, wherein the steerable catheter is configured to dispose the cord in an inverted configuration within the second chamber of the heart.

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

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

24. The delivery system according to 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. The delivery system according to claim 24, wherein the inner shaft is configured to receive a positioning tool, and the positioning tool is configured to adjust the position of the valve anchor when the valve anchor is wrapped around the chordae tendineae of the diseased valve.

26. The delivery system according to 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. The system according to claim 24, wherein retraction of the valve delivery catheter proximally is configured to be retracted proximally to expand the prosthetic valve.

28. A delivery system for delivering a prosthetic valve to a diseased valve of the heart, a cord configured to be connected to a valve anchor surrounding at least a portion of the chordae tendineae of the diseased valve, the cord further configured to extend from a position external to the heart through at least the first chamber of the heart into the 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 along the cord and connect to the proximal portion of the valve anchor, and the positioning tool includes one or more regions configured to bend when an axial compressive force is applied to the positioning tool to dispose the positioning tool in a predetermined shape, a delivery system.

29. The delivery system according to claim 28, wherein the predetermined shape includes an inversion portion configured to be positioned subannularly with respect to the valve anchor in the second chamber of the heart.

30. The delivery system according to claim 28, wherein the predetermined shape includes a substantially U-shaped bend.

31. The delivery system according to claim 28, wherein the one or more regions include one or more notches along a portion around the elongated body, and a width gap of the one or more notches decreases by compression of the positioning tool.

32. The delivery system according to 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 the center of the valve anchor.

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

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

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

36. The delivery system according to claim 33, wherein the prosthetic valve expands by retraction of the valve delivery catheter proximally.

37. The delivery system according to claim 28, wherein the predetermined shape is configured to transmit the force applied to the valve anchor in a direction toward the surface of the diseased valve and move the valve anchor toward the surface of the diseased valve.

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

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

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