Prosthetic valves with mechanically coupled leaflets

Patent metadata

Field	Value
Publication number	US-11986387-B2
Application number	US-202117377091-A
Country	US
Kind code	B2
Filing date	Jul 15, 2021
Priority date	Sep 27, 2017
Publication date	May 21, 2024
Grant date	May 21, 2024

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with a leaflet attachment region of a leaflet. Some embodiments include a leaflet retention feature that engages the leaflet frame projections and operates to secure the leaflet to the leaflet frame. Methods of making and using such prosthetic valve devices are also described.

First claim

What is claimed is:

1. A prosthetic valve defining an inflow direction into the prosthetic valve and an outflow direction out of the prosthetic valve, the prosthetic valve comprising:
a plurality of leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge; and
a frame including a commissure post extending in the outflow direction that defines a first slot and a second slot that diverge with respect to each other in the outflow direction, at least a portion of the leaflet attachment region of the respective first and second leaflets being coupled to the frame at the respective first and second slots.

2. A prosthetic valve defining an inflow direction into the prosthetic valve and an outflow direction out of the prosthetic valve in operation, the prosthetic valve comprising:
a plurality of leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge opposite a base; and
a frame including a commissure post that includes,
a first tine including a first interior edge and a first exterior edge opposite the first interior edge,
a second tine including a second interior edge and a second exterior edge opposite the second interior edge,
a spine positioned between the first and second tines such that the interior edges of the first and second tines face the spine,
a first slot defined between the first tine and the spine, the leaflet attachment region of the first leaflet extending through the frame at the first slot, and
a second slot defined between the second tine and the spine, the leaflet attachment region of the second leaflet extending through the frame at the second slot, the first and second slots diverging from one another in the outflow direction.

3. The prosthetic valve of claim 2 , wherein the leaflet attachment regions of the first and second leaflets at the first and second slots are divergent in the outflow direction.

4. The prosthetic valve of claim 2 , wherein the first and second leaflets each define two termini at an intersection of the leaflet free edge and the leaflet attachment region of the respective leaflet, the leaflet attachment region of each leaflet being coupled to the frame such that the leaflet attachment region adjacent the terminus of the first and second leaflets when positioned adjacent to one another diverge relative to each other from a location away from the terminus to the terminus.

5. The prosthetic valve of claim 2 , wherein the free edges of the first and second leaflets are divergent in the outflow direction adjacent the first and second slots.

6. The prosthetic valve of claim 2 , further comprising a first projection extending from the first exterior edge of the first tine and a second projection extending from the second exterior edge of the second tine, wherein the leaflet attachment region of the first leaflet wraps around the first tine and engages the first projection, and wherein the leaflet attachment region of the second leaflet wraps around a portion of the second tine and engages the second projection.

7. The prosthetic valve of claim 6 , wherein the first projection extends through the leaflet attachment region of the first leaflet, and wherein the second projection extends through the leaflet attachment region of the second leaflet.

8. The prosthetic valve of claim 6 , further comprising a leaflet retention member coupled to the frame such that the leaflet attachment region of the first leaflet or the second leaflet is situated between the frame and the leaflet retention member.

9. The prosthetic valve of claim 8 , wherein the leaflet retention member engages the first projection and the second projection to secure the leaflet retention member to the frame, wherein the leaflet retention member includes a first portion that extends along a frame inner surface of the first projection, and wherein the leaflet retention member includes a second portion that extends along a frame outer surface of the second projection.

10. The prosthetic valve of claim 8 , wherein the leaflet retention member is a fiber.

11. The prosthetic valve of claim 8 , further comprising a jacket molded over the leaflet retention member.

12. The prosthetic valve of claim 11 , wherein the jacket is formed of a flexible polymer.

13. The prosthetic valve of claim 2 , wherein the spine is positioned between at least a portion of the first and second leaflets.

14. The prosthetic valve of claim 2 , wherein a gap is defined between the free edges of the first and second leaflets adjacent the commissure post.

15. The prosthetic valve of claim 2 , wherein an end of the first slot is an open end and wherein an end of the first tine is a free end.

16. The prosthetic valve of claim 2 , wherein the first tine has a first end and a second end and wherein the first and second ends are each integral to the frame.

17. The prosthetic valve of claim 2 , wherein the first tine extends from the commissure post at a position proximate a free end of the commissure post.

18. A prosthetic valve comprising:
a plurality of leaflets including a first leaflet and a second leaflet, each leaflet having a leaflet attachment region and a free edge opposite a base; and
a frame that includes,
a first tine including a first interior edge and a first exterior edge opposite the first interior edge,
a second tine including a second interior edge and a second exterior edge opposite the second interior edge,
a spine positioned between the first and second tines such that the interior edges of the first and second tines face the spine; and
a first slot defined between the first tine and the spine, the leaflet attachment region of the first leaflet extending through the first slot, and
a second slot defined between the second tine and the spine, the leaflet attachment region of the second leaflet extending through the second slot, the first slot having a first diverging portion and the second slot having a second diverging portion, the first and second diverging portions of the first and second slots diverging from one another in an outflow direction.

19. The prosthetic valve of claim 18 , wherein the first slot further includes a first parallel portion and the second slot further includes a second parallel portion, the first and second parallel portions extending parallel to one another in the outflow direction.

20. The prosthetic valve of claim 18 , wherein the leaflet attachment regions of the first leaflet and the second leaflet diverge in the outflow direction as the leaflet attachment regions extend through the first slot and the second slot.

21. The prosthetic valve of claim 18 , wherein the first and second leaflets each define two termini at an intersection of the leaflet free edge and the leaflet attachment region of the respective leaflet, the leaflet attachment region of each leaflet being coupled to the frame such that the leaflet attachment region adjacent the terminus of the first and second leaflets when positioned adjacent to one another diverge relative to each other from a location away from the terminus to the terminus.

22. The prosthetic valve of claim 18 , further comprising a first projection extending from the first exterior edge of the first tine and a second projection extending from the second exterior edge of the second tine, wherein the leaflet attachment region of the first leaflet wraps around the first tine and engages the first projection, a

Assignees

• Edwards Lifesciences Corp

Inventors

• Dienno Dustin V
• Hartman Cody L
• Titone Ryan S
• Arcaro David J
• Manygoats Jr Roy

Classifications

• A61F2230/0026

  trapezoidal · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2418 Primary

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

• A61F2/2412 Primary

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

• A61F2/2433

  using balloon catheter · CPC title