EP-4734879-A1 - DEVICES AND METHODS FOR CINCHING A SIDE-DELIVERED PROSTHETIC HEART VALVE FOR DELIVERY AND DEPLOYMENT IN A NATIVE ANNULUS

EP4734879A1EP 4734879 A1EP4734879 A1EP 4734879A1EP-4734879-A1

Abstract

A side-deliverable prosthetic valve includes a valve frame and a flow control component mounted within a central channel of the valve frame and configured to permit blood flow through the central channel in a direction along a central axis of the prosthetic valve. An actuator is removably attached to a proximal subannular anchoring element of the valve frame. A first portion of the actuator is removably attached to an interior surface of the valve frame in at least one location distal to the proximal subannular anchoring element. The first portion is configured to pull the proximal subannular anchoring element inwardly toward the central axis. A second portion of the actuator is removably attached, at least in part, to an exterior surface of the valve frame. The second portion is configured to pull the proximal subannular anchoring element outwardly away from the central axis.

Inventors

CHRISTIANSON, MARK
EKVALL, CRAIG
VIDLUND, ROBERT

Assignees

VDyne, Inc.

Dates

Publication Date: 20260506
Application Date: 20240625

Claims (20)

1. A side-deliverable prosthetic valve, the prosthetic valve comprising: a valve frame defining a central channel extending along a central axis of the prosthetic valve, the valve frame including a proximal subannular anchoring element; a flow control component mounted within the central channel and configured to permit blood flow therethrough in a direction along the central axis; and an actuator configured to be removably attached to the proximal subannular anchoring element, the actuator including a first portion removably attached to an interior surface of the valve frame in at least one location distal to the proximal subannular anchoring element, the first portion configured, in response to a proximally directed force, to pull the proximal subannular anchoring element inwardly toward the central axis to a first configuration, the actuator including a second portion removably attached, at least in part, to an exterior surface of the valve frame, the second portion configured, in response to a proximally directed force, to pull the proximal subannular anchoring element outwardly away from the central axis from the first configuration to a second configuration.
2. The prosthetic valve of claim 1, wherein the prosthetic valve is compressible along the central axis and a lateral axis perpendicular to the central axis to place the prosthetic valve in a compressed configuration for side-delivery into a chamber of a heart via a delivery catheter, wherein each of the central axis and the lateral axis is perpendicular to a longitudinal axis of the delivery catheter when the prosthetic valve is in the compressed configuration within the delivery catheter, and wherein the prosthetic valve is configured to transition from the compressed configuration to an expanded configuration when the prosthetic valve is released from the delivery catheter into the chamber of the heart.
3. The prosthetic valve of claim 2, wherein the valve frame includes supra-annular member, a subannular member, and a transannular member coupled therebetween, the transannular member defining the central channel and including a plurality of wire struts that define a plurality of diamond-shaped cells, the diamond-shaped cells having an orientation that allows compression of the prosthetic valve along the central axis.
4. The prosthetic valve of claim 3, wherein the first portion of the actuator includes a tether removably attached to the proximal subannular anchoring element, a portion of the tether disposed in the central channel and removably attached to the interior surface along a strut from the plurality of struts.
5. The prosthetic valve of claim 4, wherein the portion of the tether being removably attached to the interior surface is such that the proximally directed force causes the tether to pull the proximal subannular anchoring element inwardly toward the central axis substantially without compressing the transannular member in a direction along the central axis.
6. The prosthetic valve of claim 2, wherein the valve frame includes supra-annular member, a subannular member, and a transannular member coupled therebetween, the proximal subannular anchoring element being formed, at least in part, by a proximal portion of the subannular member.
7. The prosthetic valve of claim 6, wherein the first portion of the actuator pulling the proximal subannular anchoring element inwardly toward the central axis to the first configuration reduces a perimeter of the subannular member to facilitate seating the prosthetic valve in an annulus of a native heart valve.
8. The prosthetic valve of claim 7, wherein the second portion of the actuator pulling the proximal subannular anchoring element outwardly away from the central axis to the second configuration increases the perimeter of the subannular member such that the perimeter of the subannular member is larger than a perimeter of the annulus of the native heart valve.
9. A method of deploying a side-deliverable prosthetic valve in an annulus of a native heart valve, the prosthetic valve having (i) a valve frame with a supra-annular member, a subannular member, and a transannular member coupled therebetween and (ii) a flow control component mounted to the valve frame and at least partially disposed in the transannular member, the method comprising: removably coupling the valve frame to a portion of a delivery system; exerting a first force on a first portion of an actuator to pull a proximal subannular anchoring element of the subannular member inwardly to a first configuration; advancing the prosthetic valve in a delivery configuration through a lumen of a delivery catheter included in the delivery system, a distal end of the delivery catheter being disposed in an atrium of the heart; releasing the prosthetic valve from the distal end of the delivery catheter; seating the prosthetic valve in the annulus of the native heart valve while the proximal subannular anchoring element is in the first configuration; and exerting a second force on a second portion of the actuator, after seating the prosthetic valve in the annulus, to pull the proximal subannular anchoring element outwardly from the first configuration to a second configuration.
10. The method of claim 9, wherein after exerting the first force to pull the proximal subannular anchoring element to the first configuration and before advancing the prosthetic valve through the lumen of the delivery catheter, the method further comprising: compressing the prosthetic valve in a first direction along a lateral axis of the prosthetic valve and a second direction along a central axis of the prosthetic valve to place the prosthetic valve in the delivery configuration, the lateral axis being perpendicular to the central axis; and loading the prosthetic valve in the delivery configuration into the lumen of the delivery catheter such that a longitudinal axis of the prosthetic valve is substantially parallel to a longitudinal axis of the delivery catheter, wherein the longitudinal axis of the prosthetic valve is perpendicular to each of the central axis and the lateral axis of the prosthetic valve.
11. The method of claim 9, wherein the proximal subannular anchoring element is formed, at least in part, by a proximal portion of the subannular member, the proximal subannular anchoring element in the first configuration is such that a perimeter of the subannular member is less than a perimeter of the annulus of the native heart valve, and the proximal subannular anchoring element in the second configuration is such that the perimeter of the subannular member is larger than the perimeter of the annulus of the native heart valve.
12. The method of claim 9, wherein the first portion of the actuator includes a first tether, and the second portion of the actuator includes a second tether, the method further comprising: releasably coupling the first tether to the proximal subannular anchoring element, the first force being a proximally directed force on the first tether that causes the first tether to pull the proximal subannular anchoring element inwardly toward a central axis of the prosthetic valve; and releasably coupling the second tether to the proximal subannular anchoring element, the second force being a proximally directed force on the second tether that causes the second tether to pull the proximal subannular anchoring element outwardly away from the central axis of the prosthetic valve.
13. The method of claim 12, wherein the transannular member includes a plurality of wire struts that define a plurality of diamond-shaped cells, the diamond-shaped cells having an orientation that allows compression of the prosthetic valve in a direction along the central axis.
14. The method of claim 13, wherein a portion of the first tether extends through the transannular member and is releasably attached to an interior surface of the transannular member along a strut from the plurality of struts.
15. The method of claim 14, wherein the portion of the first tether is releasably attached to the interior surface of the transannular member in at least one location distal to the proximal subannular anchoring element.
16. The method of claim 14, wherein the portion of the first tether being releasably attached to the interior surface along the strut is such that exerting the proximally directed force on the first tether pulls the proximal subannular anchoring element inwardly toward the central axis substantially without compressing the transannular member in the direction along the central axis.
17. The method of claim 12, further comprising: locking the proximal subannular anchoring element in the second configuration.
18. The method of claim 17, wherein locking the proximal subannular anchoring element includes pulling the second tether in a proximal direction such that a lock along the second tether engages a portion of the valve frame.
19. A method of coupling an actuator to a valve frame of a side-deliverable prosthetic valve, the valve frame having a supra-annular member, a subannular member, and a transannular member coupled therebetween, the transannular member including a plurality of wire struts that define a plurality of diamond-shaped cells, the method comprising: inserting a tether of the actuator through a waypoint defined by the supra-annular member; removably attaching the tether to a plurality of attachment points mounted to an interior surface of the transannular member along a strut from the plurality of struts; removably attaching the tether to a proximal subannular anchoring element formed, at least in part, by the subannular member of the valve frame; disposing a distal end portion of the tether about a guidewire catheter extending through the waypoint of the supra-annular member; and inserting the guidewire catheter through a guidewire coupler mounted to a distal portion of the subannular member to temporarily secure the distal end portion of the tether to the distal portion of the subannular member.
20. The method of claim 19, wherein the distal end portion of the tether forms a loop allowing the distal end portion of the tether to be disposed about the guidewire catheter.

Description

DEVICES AND METHODS FOR CINCHING A SIDE-DELIVERED PROSTHETIC HEART VALVE FOR DELIVERY AND DEPLOYMENT IN A NATIVE ANNULUS CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63/510,754, filed June 28, 2023, entitled “Devices and Methods for Cinching a Side-Delivered Prosthetic Heart Valve for Deployment in a Native Annulus,” and U.S. Provisional Patent Application No. 63/514,421, filed July 19, 2023, entitled “Devices and Methods for Cinching a Side-Delivered Prosthetic Heart Valve for Delivery and Deployment in a Native Annulus,” the disclosure of each of which is incorporated herein by reference in its entirety. BACKGROUND [0002] Embodiments described herein relate generally to transcatheter prosthetic heart valves and more particularly, to devices, systems, and/or methods for cinching side-deliverable transcatheter prosthetic heart valves during, for example, deployment into an annulus of a native valve. [0003] Prosthetic heart valves can pose challenges for delivery, deployment, and/or retrieval within a heart, particularly for delivery by catheters through the patient’s vasculature rather than through a surgical approach. Delivery of traditional transcatheter prosthetic valves generally includes compressing the valve in a radial direction and loading the valve into a delivery catheter such that a central annular axis of the valve is parallel to a lengthwise or longitudinal axis of the delivery catheter. In other words, traditional prosthetic valves are loaded into a delivery catheter such that a radial extent of the valve is aligned with and/or fits within a radial extent of a lumen extending through the delivery catheter. The valves are deployed from an end of the delivery catheter and expanded outwardly in a radial direction from the central annular axis. The vasculature of a patient, however, places limitations on a diameter of the delivery catheter, which in turn, places limits on the radial extent of the lumen extending through the delivery catheter, and thus, limits the expanded size (e.g., diameter) of a prosthetic valve delivered using the traditional, radial compressed delivery method. The competing interest of minimizing delivery catheter size presents challenges to increasing the expanded diameter of radially compressed valves (e.g., trying to compress too much material and structure into too little space). Moreover, the orientation of the traditional valves during deployment can create additional challenges when trying to align the valves with the native valve annulus. [0004] Some transcatheter prosthetic valves can be configured for side and/or orthogonal delivery, which can allow for an increase in an expanded diameter relative to traditionally delivered valves. With side delivery, for example, the valve can be placed in a compressed or delivery configuration and loaded into a delivery catheter such that a central annular axis of the valve is substantially perpendicular and/or orthogonal to the lengthwise or longitudinal axis of the delivery catheter. More particularly, the valve can be compressed axially (e.g., along the central annular axis) and laterally (e.g., perpendicular to each of the central annular axis and a longitudinal axis of the valve), and uncompressed or elongated longitudinally (e.g., in a direction parallel to the lengthwise or longitudinal axis of the delivery catheter). The compressed valve (e.g., the valve in a delivery configuration) can be loaded into a lumen of the delivery catheter in a side-ways or orthogonal orientation (relative to an orientation of traditionally delivered valves), in which the central annular axis of the valve is substantially perpendicular and/or orthogonal to the lengthwise or longitudinal axis of the delivery catheter (e.g., the longitudinal axis of the valve is parallel to the lengthwise or longitudinal axis of the delivery catheter). Once loaded, the compressed valve can be advanced through the lumen of the delivery catheter and released from the end of the delivery catheter (e.g., into a chamber of the heart such as an atrium). Furthermore, in some instances, the side-ways or orthogonal orientation of the released side-delivered valve relative to the delivery catheter, in general, results in the valve being in a desired orientation relative to the native valve annulus. [0005] While side delivery can allow larger valves to be delivered to the heart and/or can simplify a process of aligning or orienting the valve relative to the native annulus (as compared to traditional delivery), challenges exist with seating side-deliverable prosthetic valves in the native annulus. For example, traditional, radially compressed valves can be maintained in an at least partially compressed state while a portion of the prosthetic valve is inserted through the annulus. Once in a desired position, the prosthetic valve can be allowed to transition to a radially uncompre