EP-4740909-A2 - PROSTHETIC HEART VALVE LEAFLET COMMISSURE ASSEMBLIES AND METHOD OF ASSEMBLING

EP4740909A2EP 4740909 A2EP4740909 A2EP 4740909A2EP-4740909-A2

Abstract

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including an annular frame and a plurality of leaflets is disclosed. As one example, the valve includes a plurality of commissures, each commissure including an attachment member including a protruding portion, a first commissure tab of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the protruding portion and secured directly to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets arranged adjacent to an opposite, second side of the protruding portion and secured directly to the attachment member.

Inventors

ZAMANI, SHAHRAM
O'DELL, Tyler Dale
LEVI, TAMIR S.
BUKIN, Michael
NIR, Noam
YOHANAN, ZIV

Assignees

Edwards Lifesciences Corporation

Dates

Publication Date: 20260513
Application Date: 20210514

Claims (9)

A prosthetic heart valve, comprising: an annular frame comprising a plurality of interconnected and angled struts defining a plurality of rows of cells arranged between an outflow end and an inflow end of the frame; and a plurality of leaflets situated within the frame, each leaflet comprising a body and two opposing commissure tabs arranged on opposite sides of the body, each commissure tab being paired with an adjacent commissure tab of an adjacent leaflet to form a commissure; wherein each commissure of the prosthetic heart valve comprises: an attachment member attached directly to angled struts defining one cell included in the plurality of rows of cells, the attachment member including a base portion extending across the cell and a protruding portion that extends radially outward from a central region of the base portion and extends radially inward toward the central longitudinal axis; a first commissure tab of a first leaflet of the plurality of leaflets folded into two overlapping layers that overlap in a lateral direction, the lateral direction arranged perpendicular to an axial direction and a radial direction that are relative to the central longitudinal axis, the two overlapping layers arranged adjacent to a first side of the protruding portion of the attachment member and secured directly to the attachment member; and a second commissure tab of a second leaflet of the plurality of leaflets folded into two overlapping layers that overlap in the lateral direction, the two overlapping layers arranged adjacent to an opposite, second side of the protruding portion of the attachment member and secured directly to the attachment member.
The prosthetic heart valve of claim 1, wherein the attachment member is attached directly to the angled struts of the cell via one or more sutures extending through the base portion of the attachment member and around the angled struts forming the cell, around a perimeter of the cell.
The prosthetic heart valve of claim 1 or claim 2, wherein a first fold between the two overlapping layers of the first commissure tab is arranged against the base portion, adjacent to a first bend between the base portion and the first side of the protruding portion, and wherein a second fold between the two overlapping layers of the second commissure tab is arranged against the base portion, adjacent to a second bend between the base portion and the second side of the protruding portion.
The prosthetic heart valve of any preceding claim, wherein the first commissure tab is secured directly to the attachment member via a first suture line extending through the two overlapping layers of the first commissure tab and the protruding portion, on the first side of the protruding portion, and wherein the second commissure tab is secured directly to the attachment member via a second suture line extending through the two overlapping layers of the second commissure tab and the protruding portion, on the second side of the protruding portion.
The prosthetic heart valve of claim 4, wherein the first commissure tab is further secured to the attachment member via a third suture line extending through the two overlapping layers of the first commissure tab and the protruding portion, on the first side of the protruding portion, the third suture line arranged at a radial location that is inward, relative to the central longitudinal axis, of the first suture line, and wherein the second commissure tab is further secured to the attachment member via a fourth suture line extending through the two overlapping layers of the second commissure tab and the protruding portion, on the second side of the protruding portion, the fourth suture line arranged at a radial location that is inward, relative to the central longitudinal axis, of the second suture line.
The prosthetic heart valve of any preceding claim, wherein the protruding portion includes two overlapping layers, each extending from a different inner end of the base portion, wherein the two overlapping layers of the protruding portion overlap in the lateral direction.
The prosthetic heart valve of any preceding claim, wherein the attachment member comprises a fabric material.
The prosthetic heart valve of claim 7, wherein the attachment member comprises a polyethylene terephthalate (PET) fabric.
The prosthetic heart valve of any preceding claim, wherein the protruding portion of the attachment member extends in the axial direction, along an entire height of each of the first commissure tab and the second commissure tab.

Description

CROSS REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Patent Application No. 63/024,951, filed May 14, 2020, which is incorporated herein by reference in its entirety. FIELD The present disclosure relates to prosthetic heart valves, and to methods and assemblies for forming commissures with leaflets of such prosthetic heart valves. BACKGROUND The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (e.g., stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery device and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic valve reaches the implantation site in the heart. The prosthetic valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic valve, or by deploying the prosthetic valve from a sheath of the delivery device so that the prosthetic valve can self-expand to its functional size. Prosthetic valves that rely on a mechanical actuator for expansion can be referred to as "mechanically expandable" prosthetic heart valves. The actuator typically takes the form of pull cables, sutures, wires and/or shafts that are configured to transmit expansion forces from a handle of the delivery apparatus to the prosthetic valve. Most expandable, transcatheter heart valves comprise a cylindrical metal frame or stent and prosthetic leaflets mounted inside the frame. The leaflets may be attached to the frame at commissure tabs (also referred to as leaflet tabs) of the leaflets. For example, a commissure may be formed by connecting the commissure tabs of two adjacent leaflets to one another, and in some embodiments, to a commissure support (or attachment) element configured to couple to a commissure support portion of the frame. The commissure or the commissure support element can then be attached to the commissure support portion of the frame via a fastener, such as a suture. Typical commissures or commissure assemblies can be relatively complex and time consuming to form and suture to the commissure support portion of the frame, in part due to the numerous stitches that can be required. Further, these types of commissures and attachment methods to the commissure support portion can be subject to wear along the numerous stitches, as well as along portions of the commissure tabs that wrap around a side and/or outer-facing surface of the commissure support portion. In some examples, the mounted commissure can deteriorate due to displacement of the commissure out of its initial, secured position, including rotating around the commissure support portion and sliding axially, up and down, along the commissure support portion. Further, in some embodiments, vertical folding of the commissure tabs (e.g., in an axial direction relative to a central longitudinal axis of the frame) to form commissures can result in a less robust attachment to the commissure support portion of the frame. Frames of prosthetic heart valves, in general, go through foreshortening and therefore the leaflets undergo changes during the crimping and expansion of the frame of the valve. Leaflets of the prosthetic heart valve can also experience stress from cyclical forces experienced during operation of the prosthetic heart valve, in vivo. For example, the repeated opening and closing of the leaflet assembly of the valve may cause degradation to the leaflets, such as degradation to a tissue collagen matric of bovine or porcine tissue that makes up the leaflets. Accordingly, a need exists for improved prosthetic heart valve leaflet assemblies, and commissures formed with such leaflet assemblies, and methods for assembling commissures to a frame of a prosthetic heart valve. SUMMARY Described herein are embodiments of prosthetic heart valves and methods for assembling prosthetic heart valves including an annular frame and leaflet assembly. In some embodiments, commissures can be formed by folding a pair of commissure tabs of adjacent leaflets in the leaflet assembly such that the folded portions of the pair of commissure tabs are arranged in a radial direction and securing the folded pair of commissure tabs to a protruding portion of an attachment member that extends outwar