Jacket for surgical heart valve

Patent metadata

Field	Value
Publication number	US-11154397-B2
Application number	US-201816129677-A
Country	US
Kind code	B2
Filing date	Sep 12, 2018
Priority date	Oct 31, 2017
Publication date	Oct 26, 2021
Grant date	Oct 26, 2021

Abstract

Various aspects of the present disclosure are directed toward apparatuses, systems, and methods that include a prosthetic valve. The prosthetic valve may include a jacket configured to cover at least one of gaps, spaces, or interfaces in a frame or between one or more leaflets attached to the frame.

First claim

What is claimed is:

1. A prosthetic valve comprising:
a frame;
one or more leaflets attached to the frame; and
a jacket surrounding the frame and configured to cover at least one of gaps, spaces, interfaces in the frame, or interfaces between the frame and the one or more leaflets to enhance the biocompatibility of the frame and the jacket is molded to at least one of the frame and the one or more leaflets and the one or more leaflets and the jacket are each formed of a first material.

2. The prosthetic valve of claim 1 , wherein the first material comprises a fluoropolymer.

3. The prosthetic valve of claim 1 , wherein the jacket includes a first portion and a second portion, and the first portion and the second portion are coupled together to join the jacket to the frame.

4. The prosthetic valve of claim 3 , wherein the first portion includes a first connector, the second portion includes a second connector, wherein the first connector snaps together with the second connector to join the first portion of the jacket with the second portion of the jacket.

5. The heart valve of claim 3 , wherein the first portion and the second portion are secured together by at least one of swaging, an adhesive, a screw, and a rivet.

6. The prosthetic valve of claim 3 , wherein the first portion of the jacket defines an outflow side of the prosthetic valve, and wherein a flange extends radially outwardly from the first portion of the jacket.

7. The prosthetic valve of claim 6 , wherein the flange is configured to operate as a tissue ingrowth boundary to help obstruct tissue ingrowth into the one or more leaflets.

8. The prosthetic valve of claim 1 , further comprising a sewing cuff arranged with the frame, wherein the jacket is configured to cover an interface between the sewing cuff and the frame.

9. The prosthetic valve of claim 8 , wherein the jacket is bonded to the sewing cuff.

10. The prosthetic valve of claim 8 , wherein a flange extends radially outwardly from the jacket on an outflow side of the sewing cuff.

11. The prosthetic valve of claim 10 , wherein the flange is longitudinally offset from the sewing cuff.

12. The prosthetic valve of claim 10 , wherein the flange is positioned between the sewing cuff and an outflow side of the one or more leaflets.

13. The prosthetic valve of claim 1 , wherein the jacket is configured to avoid thrombosis to enhance the biocompatibility of the frame.

14. The prosthetic valve of claim 1 , wherein the jacket is configured to block tissue ingrowth into the one or more leaflets and to enhance the biocompatibility of the frame.

15. The prosthetic valve of claim 1 , wherein the jacket is configured to promote tissue ingrowth.

16. The prosthetic valve of claim 1 , wherein the jacket includes an outflow edge and a transition between the one or more leaflets and the outflow edge includes a fillet.

17. The prosthetic valve of claim 16 , wherein the fillet includes a nonlinear surface.

18. The prosthetic valve of claim 16 , wherein the fillet extends radially inwardly.

19. The prosthetic valve of claim 1 , wherein the jacket is formed of a rigid material.

20. The prosthetic valve of claim 19 , wherein the jacket is formed of a TFE-PMVE copolymer.

21. The prosthetic valve of claim 1 , wherein a portion of the jacket is formed of a flexible polymer.

22. The prosthetic valve of claim 21 , wherein the flexible polymer is silicone.

23. The prosthetic valve of claim 21 , wherein another portion of the jacket is formed of a rigid material.

24. The prosthetic valve of claim 1 , further comprising a conduit and wherein the jacket is coupled to the conduit to form a valved conduit.

25. A prosthetic valve comprising:
a frame;
one or more leaflets attached to the frame to define one or more frame-to-leaflet interfaces; and
a jacket that encapsulates the one or more frame-to-leaflet interfaces and is configured to isolate the interface from blood flow and the jacket includes an outflow edge and a transition between the one or more leaflets and the outflow edge includes a fillet and the fillet extends radially inwardly.

26. The prosthetic valve of claim 25 , wherein the jacket is configured to create tissue ingrowth boundaries.

27. The prosthetic valve of claim 25 , wherein the jacket is configured to alter the blood flow.

28. The prosthetic valve of claim 25 , further comprising a sewing cuff, and the jacket is bonded to at least one of the frame, the leaflets, and the sewing cuff.

29. The prosthetic valve of claim 28 , wherein a flange extends radially outwardly from the jacket on an outflow side of the sewing cuff.

30. The prosthetic valve of claim 29 , wherein the flange is longitudinally offset from the sewing cuff.

31. The prosthetic valve of claim 29 , wherein the flange is configured to operate as a tissue ingrowth boundary to help obstruct tissue ingrowth into the one or more leaflets.

32. The prosthetic valve of claim 29 , wherein the flange is positioned between the sewing cuff and an outflow side of the one or more leaflets.

33. The prosthetic valve of claim 25 , wherein the jacket is overmolded over the frame.

34. The prosthetic valve of claim 25 , wherein the jacket is configured to promote tissue ingrowth.

35. The prosthetic valve of claim 34 , wherein the jacket is configured to restrict the tissue ingrowth to the frame without extending onto the one or more leaflets.

36. The prosthetic valve of claim 34 , wherein the jacket includes a surface modification to promote tissue ingrowth.

37. The prosthetic valve of claim 25 , wherein the fillet includes a nonlinear surface.

38. A prosthetic valve comprising:
a frame;
one or more leaflets attached to the frame;
a jacket surrounding the frame and configured to cover at least one of gaps, spaces, interfaces in the frame, or interfaces between the frame and the one or more leaflets to enhance the biocompatibility of the frame; and
a sewing cuff arranged with the frame, wherein the jacket is configured to cover an interface between the sewing cuff and the frame.

Assignees

• Gore & Ass

Inventors

• Arcaro David J
• Colavito Kyle W
• Dienno Dustin V
• Hartman Cody L
• Manygoats Jr Roy
• Titone Ryan S
• Smith Ryan D
• Sprinkle Joshua A
• Smith Benjamin A
• Goepfrich James L
• Shepard Michael J

Classifications

• A61F2/2412 Primary

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

• A61F2220/0041

  using additional screws, bolts, dowels or rivets, e.g. connecting screws · CPC title

• A61F2250/0051

  differing in tissue ingrowth capacity, e.g. made from both ingrowth-promoting and ingrowth-preventing parts · CPC title

• A61L27/28

  Materials for coating prostheses · CPC title

• A61L27/18

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds · CPC title