Commissure attachment for prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-12433747-B2
Application number	US-202117466331-A
Country	US
Kind code	B2
Filing date	Sep 3, 2021
Priority date	Mar 4, 2019
Publication date	Oct 7, 2025
Grant date	Oct 7, 2025

Abstract

A prosthetic heart valve includes an annular frame that is radially collapsible and radially expandable, a plurality of leaflets situated within the frame, each leaflet having opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure, and a plurality of post members mounted on an interior surface of the frame. The at least one commissure includes a commissure attachment assembly including a support member disposed at least partially around the commissure tab portions and the commissure tab portions are folded around the support member. The commissure attachment assembly is secured to a first post member of the plurality of post members such that the commissure tab portions are positioned between the first post member and the support member.

First claim

The invention claimed is:

1. A prosthetic heart valve, comprising:
an annular frame including a plurality of interconnected strut members, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration;
a plurality of leaflets situated within the frame, each leaflet comprising opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure;
a plurality of post members mounted on an interior surface of the frame;
wherein the at least one commissure comprises a commissure attachment assembly, the commissure attachment assembly comprising a support member, the support member comprising a central opening disposed at least partially around the commissure tab portions such that the commissure tab portions extend through the central opening of the support member;
wherein the commissure tab portions of the commissure attachment assembly are folded around the support member and away from each other; and
wherein the commissure attachment assembly is secured to a first post member of the plurality of post members such that the support member is aligned in the radial direction with the first post member and the commissure tab portions are positioned between, in the radial direction, the first post member and the support member, wherein the radial direction is relative to a central longitudinal axis of the frame.

2. The prosthetic heart valve of claim 1 , wherein the central opening is bound by two side edge portions, an upper portion and a lower portion of the support member such that the central opening is positioned completely around the commissure tabs portions.

3. The prosthetic heart valve of claim 1 , wherein:
one of the leaflets of the commissure attachment assembly is a first leaflet and the other leaflet of the commissure attachment assembly is a second leaflet;
the support member comprises a first row of openings to receive sutures securing the first leaflet to the support member; and
the support member comprises a second row of openings offset from the first row of openings, the second row of openings being configured to receive sutures securing the second leaflet to the support member.

4. The prosthetic heart valve of claim 1 , wherein the support member is configured to engage with a corresponding recess or extension in the first post member to hold the commissure attachment assembly in place.

5. The prosthetic heart valve of claim 1 , wherein:
the frame is a mechanically-expandable frame; and
the post members comprise actuator components configured to mechanically expand and collapse the frame.

6. The prosthetic heart valve of any of claim 2 , wherein at least a portion of the support member comprises a flexible material and wherein the support member comprises a plurality of spaced apart openings on both sides of the central opening.

7. The prosthetic heart valve of claim 1 , wherein the central opening is defined between by two side portions of the support member that are arranged on opposite sides of the central opening, and wherein the support member is configured to clamp the commissure tab portions within the central opening.

8. The prosthetic heart valve of claim 7 , wherein the two side portions of the support member are configured to bend toward one another and in an outward radial direction, relative to a central longitudinal axis of the frame, between a relaxed state and a bent state, wherein a width of the central opening is smaller when the support member is in the bent state, wherein the support member is in the bent state when it is secured to the first post member, and wherein inner edges of the central opening are configured to exert a clamping force against the commissure tab portions arranged therein when the support member is in the bent state.

9. The prosthetic heart valve of claim 7 , wherein the two side portions of the support member are configured to bend toward one another, around a central longitudinal axis of the support member between a bent state and a released and unbent state, wherein when the support member is in the bent state a width of the central opening is a wider, first width, and wherein when the support member is in the released and unbent state the width of the central opening is a narrower, second width and side edges of the two side portions defining the central opening exert a force against a portion of the commissure tab portions arranged therein.

10. The prosthetic heart valve of claim 7 , wherein a width of the central opening is defined between its side edges, wherein inner portions of the two side portions are arranged adjacent to respective side edges of the side edges, and wherein when the commissure tab portions are arranged within the central opening, the inner portions are bent radially outward, relative to a central longitudinal axis of the frame, and are biased against the commissure tab portions.

11. The prosthetic heart valve of claim 1 , wherein the support member comprises a plurality of spaced apart openings arranged on both sides of the central opening, and wherein the commissure attachment assembly is secured to the first post member via one or more elastically deformable attachment members, wherein each of the one or more elastically deformable attachment members extends through two oppositely arranged openings of the plurality of openings, loops around an outer side of the actuator member, and has end portions that are arranged within one or more channels that are recessed into a surface of the outer side of the actuator component.

12. A prosthetic heart valve, comprising:
an annular frame including a plurality of interconnected strut members, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration;
a plurality of leaflets situated within the frame, each leaflet comprising opposing commissure tab portions on opposite sides of the leaflet, each commissure tab portion being paired with an adjacent commissure tab portion of an adjacent leaflet to form at least one commissure; and
a plurality of post members mounted on an interior surface of the frame;
wherein the at least one commissure comprises a commissure attachment assembly, the commissure attachment assembly comprising a support member disposed completely around the commissure tab portions such that the commissure tab portions extend through a central opening of the support member, wherein the central opening is bound by two side portions that are disposed on opposite sides of the central opening, an upper portion, and a lower portion of the support member;
wherein at least a portion of the support member comprises a flexible material and is configured to bend in a radially inward or outward direction relative to a central longitudinal axis of the frame;
wherein the commissure attachment assembly is secured to a first post member of the plurality of post members; and
wherein the two side portions of the support member apply a clamping force against the commissure tab portions arranged within the central opening.

13. The prosthetic heart valve of claim 12 , wherein the support member is configured to bend in an outward radial direction, relative to the central longitudinal axis, from a relaxed state to a bent state, wherein the support member is in the bent state when it is secured to the first post member, and wherein inner edges of the two side portions are arranged closer together when the support member is in the bent state, as compared to the relaxed state, and apply the c

Assignees

• Edwards Lifesciences Corp

Inventors

• Levi Tamir S
• Nir Noam
• Bukin Michael
• Maimon David
• Yushtein Haim

Classifications

• A61F2220/0091

  connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2412

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/243 Primary

  Deployment by mechanical expansion · CPC title