US-12622780-B2 - Prosthetic heart valve

US12622780B2US 12622780 B2US12622780 B2US 12622780B2US-12622780-B2

Abstract

A prosthetic heart valve includes an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure supports members outside of the frame; and a plurality of quadrilateral valve leaflets each having a main body having an inflow edge and an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the main body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, each pair of leaflets tabs extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure tab assembly, wherein each commissure tab assembly is located on the exterior of the frame and the main body of each leaflet is located on the interior of the frame.

Inventors

Nikolai Gurovich

Assignees

EDWARDS LIFESCIENCES CORPORATION

Dates

Publication Date: 20260512
Application Date: 20221007

Claims (20)

1 . A prosthetic heart valve comprising: an expandable annular frame having an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis; a plurality of commissure support members outside of the frame; and a plurality of quadrilateral valve leaflets each having a main body having an inflow edge, an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the main body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, each pair of leaflet tabs extending through a respective opening of the frame and coupled to one of the commissure support members to form a commissure tab assembly, wherein each commissure tab assembly is located on the exterior of the frame and the main body of each leaflet is located on the interior of the frame; wherein the inflow edges of the leaflets and the inflow end of the frame are aligned, the outflow edges of the leaflets are axially offset from the outflow end of the frame along the longitudinal axis, and for each commissure tab assembly, the commissure support member has a width greater than a width of a respective frame opening through which the pair of leaflet tabs extends.
2 . The prosthetic heart valve of claim 1 , wherein each leaflet tab is wrapped circumferentially around a respective commissure support member.
3 . The prosthetic heart valve of claim 1 , wherein each leaflet tab forms a first fold extending radially outwardly from the main body of a respective leaflet, a second fold extending circumferentially along an inner surface of a respective commissure support member, and a third fold extending circumferentially along an outer surface of the commissure support member.
4 . The prosthetic heart valve of claim 3 , wherein the first folds of each pair of leaflet tabs extends through a respective opening of the frame.
5 . The prosthetic heart valve of claim 3 , wherein each leaflet tab is secured to a respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support member, and the third fold of the leaflet tab.
6 . The prosthetic heart valve of claim 1 , wherein each leaflet tab has an outflow edge axially offset from the outflow edge of the main body of the leaflet and an inflow edge axially offset from the inflow edge of the main body of the leaflet.
7 . The prosthetic heart valve of claim 1 , wherein each commissure tab assembly is coupled to the outer surface of the frame by one or more sutures.
8 . The prosthetic heart valve of claim 1 , wherein for each commissure tab assembly, the commissure support member has a height greater than a height of a respective frame opening through which the pair of leaflet tabs extends.
9 . The prosthetic heart valve of claim 1 , wherein the openings of the frame are arranged in circumferentially extending rows of openings, including a first row at the inflow end of the frame and a second row at the outflow end of the frame.
10 . The prosthetic heart valve of claim 9 , wherein the majority of the openings of the second row are uncovered by the leaflets when the leaflets are in an open position.
11 . A prosthetic heart valve comprising: an annular frame having an inflow end, an outflow end, and a plurality of openings; a plurality of commissure support members each having an outer surface and an inner surface; and a plurality of valve leaflets each having a main body having an inflow edge, an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the main body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, wherein each pair of leaflet tabs extends through a respective opening of the frame and is coupled to one of the commissure supports outside of the frame to form a commissure tab assembly; wherein each leaflet tab forms a first fold extending radially outwardly from the main body of a respective leaflet through a respective opening of the frame, a second fold extending circumferentially between the inner surface of a respective support member and an exterior surface of the frame, and a third fold extending circumferentially along the outer surface of the support member.
12 . The prosthetic heart valve of claim 11 , wherein each leaflet is configured to open under fluid pressure such that the outflow edges of the leaflets contact the frame.
13 . The prosthetic heart valve of claim 11 , wherein each commissure support member comprises a rectangular plate with flat and parallel inner and outer surfaces.
14 . The prosthetic heart valve of claim 11 , wherein each leaflet tab is secured to a respective commissure support member with one or more sutures extending through the second fold of the leaflet tab, the commissure support member, and the third fold of the leaflet tab.
15 . The prosthetic heart valve of claim 14 , wherein each commissure support comprises plurality of apertures through which the one or more sutures extend.
16 . The prosthetic heart valve of claim 11 , further comprising an outer skirt having a first end located at the inflow end of the frame and a second end located between the inflow end and the outflow end of the frame, the outer skirt extending along the outer surface of the frame from the first end to the second end.
17 . The prosthetic heart valve of claim 16 , wherein the outer skirt partially covers the commissure tab assemblies.
18 . The prosthetic heart valve of claim 11 , wherein the prosthetic heart valve is devoid of any fabric material inside of the frame.
19 . The prosthetic heart valve of claim 11 , wherein the commissure assemblies are devoid of any fabric material.
20 . The prosthetic heart valve of claim 1 , wherein the commissure support members are made of metal.

Description

CROSS-REFERENCED TO RELATED APPLICATION The present application is a continuation of PCT patent application no. PCT/US2021/025869, filed Apr. 6, 2021, which application claims the benefit of U.S. Provisional Application No. 63/006,190, filed Apr. 7, 2020, each of which is incorporated herein in its entirety by this specific reference. FIELD The present disclosure relates to prosthetic heart valves, and to methods and assemblies for forming leaflet assemblies and attaching leaflet assemblies to a frame 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 apparatus and advanced through the patient's vasculature (e.g., through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart 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 heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size. Most expandable, transcatheter heart valves are used for mid to high expansion diameters, for example diameters ranging from 23 to 29 mm. While smaller prosthetic valves available, such as those with diameters of about 20 mm or less, smaller diameter valves are rarely used due to a variety of challenges. For example, smaller diameter prosthetic valves generally cause higher pressure gradients along the prosthetic valve, which can lead to various clinical risks, such as cavitation. Also, smaller prosthetic valves typically have shorter paravalvular sealing elements, which makes it more challenging for the clinician to align the prosthetic valve at the native annulus. Smaller prosthetic valves also can have relatively shorter frames, which can result in leaflet overhang, in which the native valve leaflets overhang the outflow end of the prosthetic valve, thereby disturbing blood flow and/or inhibiting full opening of the prosthetic leaflets. Further, smaller prosthetic valves have relatively smaller frame openings, which can inhibit coronary access through the frame with a catheter in a subsequent procedure. Finally, valve-in-valve procedures involving implantation of a second prosthetic valve in a previously implanted prosthetic valve is more challenging with relatively smaller prosthetic valves because it is more difficult to properly align and orient the second prosthetic valve within the previously implanted prosthetic valve while maintaining access to the coronary ostia. Accordingly, a need exists for improved prosthetic heart valve leaflet assemblies and methods for assembling the leaflet assemblies to a frame of the prosthetic heart valve. SUMMARY Described herein are embodiments of methods for assembling a prosthetic heart valve including a leaflet assembly, methods of assembling a leaflet sub-assembly of the leaflet assembly, and prosthetic heart valves including a leaflet assembly. In one representative embodiment, a prosthetic heart valve is provided. The prosthetic heart valve includes an expandable annular frame, a plurality of commissure support members outside of the frame, and a plurality of quadrilateral valve leaflets. The expandable annular frame has an inflow end, an outflow end, an interior, an exterior, a plurality of openings, and a longitudinal axis. Each of the plurality of quadrilateral valve leaflets have a main body having an inflow edge and an outflow edge, and a pair of opposing leaflet tabs extending from opposite sides of the main body, each leaflet tab being paired with an adjacent leaflet tab of an adjacent leaflet, each pair of leaflets tabs extending through a respective opening of the frame and coupled to one of the commissure supports to form a commissure tab assembly, wherein each commissure tab assembly is located on the exterior of the frame and the main body of each leaflet is located on the interior of the frame. The inflow edges of the leaflets and the inflow end of the frame are aligned, and the outflow edges of the leaflets are axially offset from the outflow end of the frame along the longitudi