Prosthetic heart valve leaflet commissure assemblies and methods

Patent metadata

Field	Value
Publication number	US-12427013-B2
Application number	US-202217901602-A
Country	US
Kind code	B2
Filing date	Sep 1, 2022
Priority date	Mar 3, 2020
Publication date	Sep 30, 2025
Grant date	Sep 30, 2025

Abstract

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.

First claim

We claim:

1. A prosthetic heart valve, comprising:
an annular frame comprising a plurality of commissure support portions;
a plurality of commissure support elements, each connected to a corresponding commissure support portion of the plurality of commissure support portions and comprising two axially-extending members that are spaced apart from one another to form an open, leaflet-receiving window; and
a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs arranged on opposite sides of the body, wherein each commissure tab is arranged adjacent to another commissure tab of an adjacent leaflet to form a pair of commissure tabs and the pair of commissure tabs are disposed in a commissure support element of the plurality of commissure support elements to form a commissure, and wherein each commissure tab of the pair of commissure tabs comprises a series of overlapping layers that include a first set of two overlapping layers that extends through the window of the commissure support element and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member of the two axially-extending members of the commissure support element, in a lateral direction that is arranged tangent to a circumference of the prosthetic heart valve and perpendicular to a radial direction that is relative to a central longitudinal axis of the prosthetic heart valve.

2. The prosthetic heart valve of claim 1 , further comprising a first reinforcing member positioned against outermost corners of a first bend between the first set of two overlapping layers and the second set of two overlapping layers of a first commissure tab of the pair of commissure tabs and a second bend between the first set of two overlapping layers and the second set of two overlapping layers of a second commissure tab of the pair of commissure tabs.

3. The prosthetic heart valve of claim 2 , wherein the first reinforcing member is centered along a centerline of the commissure, the centerline aligned along the radial direction and centered in the window and wherein the first reinforcing member is positioned against outermost surfaces, relative to the radial direction, of the first and second commissure tabs.

4. The prosthetic heart valve of claim 2 , further comprising, for each commissure tab, a second reinforcing member arranged between an innermost corner of a bend between the first set of two overlapping layers and the second set of two overlapping layers and the corresponding axially-extending member.

5. The prosthetic heart valve of claim 4 , wherein each of the first reinforcing member and the second reinforcing member comprise a biocompatible material that is more rigid than the commissure tab and wherein the biocompatible material is one or more of a fabric and polymer.

6. The prosthetic heart valve of claim 4 , wherein the second reinforcing member surrounds only a portion of a circumference of an outer surface of the corresponding axially-extending member.

7. The prosthetic heart valve of claim 4 , wherein the second reinforcing member surrounds a majority of a circumference of an outer surface of the corresponding axially-extending member.

8. The prosthetic heart valve of claim 4 , wherein for each commissure tab of the commissure, a first line of sutures extends through the first reinforcing member, two layers of the commissure tab between the outermost and innermost corners of the bend between the first set of two overlapping layers and the second set of two overlapping layers, and the second reinforcing member.

9. The prosthetic heart valve of claim 4 , wherein for each commissure tab of the commissure, a second line of sutures extends through the second set of two overlapping layers and an end portion of the commissure tab that wraps around an inner side of the corresponding axially-extending member and forms a third overlapping layer with the second set of two overlapping layers which overlap in the radial direction and wherein the second line of sutures is arranged laterally outward of the corresponding axially-extending member.

10. The prosthetic heart valve of claim 1 , wherein each commissure tab comprises a first tab portion extending radially outward from the body of the corresponding leaflet and through the window, a second tab portion extending laterally outward from the first tab portion and across the outer side of the corresponding axially-extending member, a third tab portion folded over from the second tab portion and extending laterally inward toward the first tab portion, a fourth tab portion extending radially inward from the third tab portion and through the window, the fourth tab portion arranged directly adjacent the first tab portion within the window, a fifth tab portion extending laterally outward from the fourth tab portion and across an inner side of the corresponding axially-extending member, and a sixth tab portion extending outward and away from the corresponding axially-extending member, in the lateral direction.

11. The prosthetic heart valve of claim 10 , wherein the sixth tab portion is arranged directly adjacent to an outer portion, relative to the lateral direction, of the third tab portion such that the commissure tab completely surrounds a circumference of an outer surface of the corresponding axially-extending member.

12. The prosthetic heart valve of claim 10 , wherein the second tab portion, third tab portion, and sixth tab portion form three overlapping layers of the commissure tab that overlap in the radial direction, laterally outward of the corresponding axially-extending member.

13. The prosthetic heart valve of claim 1 , wherein the commissure support element further comprises a coupling portion connected to and radially offset from the two axially-extending members and wherein the coupling portion is coupled to the corresponding support portion of the frame.

14. The prosthetic heart valve of claim 1 , wherein the two axially-extending members forming the window include a first tubular member and a second tubular member arranged adjacent to an inner surface of the corresponding commissure support portion, wherein the commissure support element further includes a first flexible member extending through the first tubular member and first upper and lower channels extending through the commissure support portion, from the inner surface to an outer surface of the commissure support portion, the first flexible member secured together on the outer surface of the commissure support portion, and wherein the commissure support element further includes a second flexible member extending through the second tubular member and second upper and lower channels extending through the commissure support portion, from the inner surface to the outer surface, the second flexible member secured together on the outer surface of the commissure support portion.

15. A method of assembling a prosthetic heart valve comprising a plurality of leaflets, comprising:
forming a plurality of commissures with the plurality of leaflets, wherein each commissure is formed by:
folding each commissure tab of each leaflet of the plurality of leaflets into a series of overlapping layers so that a first set of two overlapping layers of the commissure tab extends in a radial direction and a second set of two overlapping layers extends in a lateral direction, outward from the first set of two overlapping layers, wherein the radial direction is relative to a central longitudinal axis of the prosthetic heart valve and the lateral direction is arranged

Assignees

• Edwards Lifesciences Corp

Inventors

• Bukin Michael
• Nir Noam
• Levi Tamir S
• Yohanan Ziv
• Sherman Elena
• Goldberg Eran
• Maimon David

Classifications

• A61F2250/0039

  differing in diameter · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/2439

  Expansion controlled by filaments · CPC title

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title