Collapsible prosthetic heart valves

• US 9,549,815 B2
• Filed: 04/14/2016
• Issued: 01/24/2017
• Est. Priority Date: 09/26/2007
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Braido, Peter N., McCarthy, Andrea L., Figueiredo, Rubem L., Schraut, Julia A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US15/098,672
• Publication Number:
  US 20160228243A1
• Time in Patent Office: 285 Days
• Field of Search: 623 21- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical

Abstract

A prosthetic heart valve includes a balloon-expandable stent including a plurality of struts and a plurality of commissure posts, each commissure post containing an elongated slot. A plurality of leaflets is made from pericardial tissue and includes flaps. An intermediate polymer sheet is disposed between the stent and the plurality of leaflets. At least one reinforcing polymer core is attached to at least one leaflet and the intermediate polymer sheet using stitches that loop around an end of the at least one leaflet. A plurality of patches covers the elongated slots of the commissure posts, the flaps of the leaflets being attached to the patches. A cuff contacts an exterior of the stent, the cuff and the intermediate polymer sheet sutured to one another so as to cover an axial end of the stent.

Claims

1. A prosthetic heart valve comprising:

a balloon-expandable stent including a plurality of struts and a plurality of commissure posts, each commissure post containing an elongated slot;

a plurality of leaflets made from pericardial tissue and including flaps;

an intermediate polymer sheet disposed between the stent and the plurality of leaflets;

at least one reinforcing polymer core attached to at least one leaflet and the intermediate polymer sheet using stitches that loop around an end of the at least one leaflet;

a plurality of patches covering the elongated slots of the commissure posts, the flaps of the leaflets being attached to the patches; and

a cuff contacting an exterior of the stent, the cuff and the intermediate polymer sheet sutured to one another so as to cover an axial end of the stent.

2. The prosthetic heart valve of claim 1, wherein each of the flaps is at least partially disposed radially outward of the stent adjacent the commissure post.

3. The prosthetic heart valve of claim 1, wherein each of the patches is disposed radially outward of a corresponding commissure post.

4. The prosthetic heart valve of claim 1, wherein each of the flaps is at least partially disposed radially outward of the stent adjacent a corresponding commissure post and each of the patches is disposed radially outward of corresponding flaps.

5. The prosthetic heart valve of claim 1, wherein the reinforcing polymer core wraps around the ends of the leaflets.

6. The prosthetic heart valve of claim 1, wherein the plurality of patches includes three patches.

7. The prosthetic heart valve of claim 6, wherein the plurality of commissure posts includes three commissure posts.

8. The prosthetic heart valve of claim 1, wherein the plurality of leaflets coapt at free edges thereof.

9. The prosthetic heart valve of claim 1, wherein the plurality of leaflets are coupled to the intermediate polymer sheet.

10. A prosthetic heart valve comprising:

a balloon-expandable stent extending between an upstream end having an edge and a downstream end and including a plurality of struts and a plurality commissure posts, each commissure post containing an elongated slot;

a polymer sheet attached to an inner surface of the stent;

a plurality of leaflets made from pericardial tissue, the leaflets having reinforced ends and being attached to the polymer sheet using stitches that whip around the reinforced ends of the leaflets;

a plurality of patches each covering an elongated slot of a corresponding commissure post, each patch being disposed radially outward of the corresponding commissure post and attached to a pair of the leaflets; and

a cuff attached to the stent, the patches extending downstream of the cuff.

11. The prosthetic heart valve of claim 10, wherein each of the plurality of patches is attached to the stent.

12. The prosthetic heart valve of claim 10, wherein the cuff and the polymer sheet are sutured to one another so as to cover the edge of the stent.

13. The prosthetic heart valve of claim 10, further comprising at least one polymer core attached to the reinforced ends of the leaflets.

14. The prosthetic heart valve of claim 13, wherein the reinforced ends of the leaflets are attached to and disposed between the polymer sheet and the at least one polymer core.

15. The prosthetic heart valve of claim 10, wherein at least some of the stitches pierce through at least one of the plurality of leaflets.

16. The prosthetic heart valve of claim 10, wherein at least some of the stitches are arranged in a parabolic pattern.

17. The prosthetic heart valve of claim 10, wherein the polymer sheet is disposed between the cuff and the plurality of leaflets.

18. The prosthetic heart valve of claim 10, wherein each of the plurality of leaflets comprises a different material than the plurality of patches.

19. A prosthetic heart valve comprising:

a balloon-expandable stent extending between a first end having a first edge and a second end and including a plurality of struts and a plurality of non-cantilevered commissure posts each containing an elongated slot;

a buffer composed of polymer and attached to an inner surface of the stent;

a plurality of leaflets made from pericardial tissue and including flaps;

a plurality of patches each covering an elongated slot of a corresponding commissure post and each being disposed radially outward thereof, each patch being attached to the stent and to a pair of adjacent flaps of adjacent leaflets; and

a cuff contacting an outer surface of the stent, the cuff and the buffer collectively covering the first edge of the stent.

20. The prosthetic heart valve of claim 19, wherein the plurality of leaflets includes reinforced ends.

21. The prosthetic heart valve of claim 20, wherein each of the reinforced ends includes a reinforcing core.

22. The prosthetic heart valve of claim 19, wherein each patch is attached to the corresponding commissure post.

23. The prosthetic heart valve of claim 19, wherein the plurality of leaflets is coupled to an inner surface of the buffer.

24. The prosthetic heart valve of claim 19, wherein the plurality of struts defines first cells and second cells, the first cells being smaller than the second cells, and the second cells being positioned adjacent the second end.

25. The prosthetic heart valve of claim 19, further comprising an equal number of leaflets, commissures posts, and patches.

26. A prosthetic heart valve comprising:

a balloon-expandable stent extending between a first end having a first edge and a second end, and including a plurality of struts and three angularly spaced commissure windows each comprising an enclosed opening between first and second axially oriented side struts;

a buffer composed of polymer and attached to an inner surface of the stent;

a plurality of leaflets each made from pericardial tissue and comprising two opposing side tabs, each side tab being paired with an adjacent side tab of an adjacent leaflet to form leaflet commissures;

a plurality of patches covering the enclosed openings of the commissure windows, the tabs of the leaflets being attached to the patches; and

a cuff contacting an exterior of the stent, the cuff and the buffer collectively covering the first edge of the stent.

27. The prosthetic heart valve of claim 26, wherein each leaflet commissure extends radially outwardly through a corresponding commissure window of the stent to a location outside of the stent and is sutured to the side struts of the commissure window.

28. The prosthetic heart valve of claim 26, wherein the tabs of the leaflets extend radially outwardly adjacent first and second axially oriented struts of corresponding windows to a location outside of the stent.

29. The prosthetic heart valve of claim 26, wherein the stent is adapted to shorten axially during radial expansion, thereby increasing axial slack in the cuff.