Granted Patent B2

US 12,653,667 · App. 18/920,663 · Granted Jun 16, 2026

Inventors: Tamir S. Levi (Zikhron Yaakov, IL); Shahram Zamani (Newport Coast, CA); Michael Bukin (Pardes Hanna, IL); Ziv Yohanan (Kfar Hahoresh, IL); Noam Nir (Pardes-Hanna, IL); Tyler Dale O′Dell (Irvine, CA); Elena Sherman (Pardes Hana, IL)

Assignee: Edwards Lifesciences Corporation

A61F2/2415A61F2/2418A61F2220/0075

Abstract

Claims (27)

1 . A method of assembling a valvular structure, comprising:

folding an integral upper tab of a first leaflet onto an integral lower tab of the first leaflet such that a first surface of the upper tab contacts a first surface of the lower tab;

disposing a first end portion of a reinforcing member on a second surface of the upper tab of the first leaflet;

disposing a commissure member adjacent a second surface of the lower tab of the first leaflet;

coupling the first end portion of the reinforcing member, the upper and lower tabs of the first leaflet, and the commissure member to one another using one or more fastening sutures;

folding an integral upper tab of a second leaflet onto an integral lower tab of the second leaflet such that a first surface of the upper tab contacts a first surface of the lower tab;

disposing the second leaflet adjacent the first leaflet such that the commissure member is positioned between the respective lower tabs;

disposing a second end portion of the reinforcing member on a second surface of the upper tab of the second leaflet; and

coupling the second end portion of the reinforcing member, the upper and lower tabs of the second leaflet, and the commissure member to one another using the one or more fastening sutures to form a commissure.

2 . The method of claim 1 , further comprising:

prior to disposing the second leaflet adjacent the first leaflet, folding the commissure member such that first and second lateral edges of the commissure member are disposed adjacent one another.

3 . The method of claim 2 , further comprising:

cutting back the first and second lateral edges of the commissure member such that they do not extend past lateral edges of the upper and lower tabs of the first and second leaflets.

4 . The method of claim 1 , wherein the one or more fastening sutures extend through the first end portion and the second end portion of the reinforcing member.

5 . The method of claim 1 , wherein the commissure member comprises first and second layers.

6 . The method of claim 1 , further comprising:

sewing one or more securing sutures through the commissure such that they extend around the lateral edges of the upper and lower tabs of the first and second leaflets to form a plurality of loops;

sliding the plurality of loops axially over a commissure support portion of an expansion and locking mechanism coupled to a frame of a prosthetic heart valve such that the leaflets are disposed within the frame; and

tightening the plurality of loops to secure the leaflets to the frame.

7 . The method of claim 6 , wherein sewing one or more securing sutures through the commissure comprises sewing the securing sutures through the reinforcing member.

8 . The method of claim 6 , wherein sewing one or more securing sutures through the commissure comprises sewing the securing sutures through the lateral edges of the upper and lower tabs of the first and second leaflets.

9 . The method of claim 1 , further comprising sewing one or more additional sutures through the commissure member to bias the upper and lower tabs of the first and second leaflets away from one another.

10 . The method of claim 1 , wherein the integral upper and lower tabs of each leaflet are first integral upper and lower tabs, and wherein each leaflet further comprises second integral upper and lower tabs arranged at an opposing end of a cusp edge portion of the leaflet.

11 . The method of claim 1 , wherein the reinforcing member comprises at least one of multi-filament suture, braided cloth, metallic braid, and metal strip.

12 . The method of claim 1 , wherein the reinforcing member comprises an Ethibond suture.

13 . The method of claim 1 , wherein the commissure member comprises PET.

14 . The method of claim 1 , wherein the reinforcing member is radially inset from the lateral edges of the upper and lower tabs of the first and second leaflets.

Assignments (1)

Continuity (4)

References Cited (382)