Polymer heart valve with perforated stent and sewing cuff

• US 6,755,857 B2
• Filed: 12/12/2001
• Issued: 06/29/2004
• Est. Priority Date: 12/12/2001
• Status: Expired due to Term

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: Sulzer Carbomedics Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Chinn, Joseph A., Moe, Riyad, Peterson, Paul C.
• Primary Examiner(s): Isabella, David J.
• Assistant Examiner(s): CHATTOPADHYAY, URMI
• Application Number:
  US10/020,337
• Publication Number:
  US 20030109922A1
• Time in Patent Office: 930 Days
• Field of Search: 623/2.1, 623/2.12, 623/2-7-, 623/2.38, 623/2.4, 623/900, 623/11.11, 623/66.1, 623/2.41, 623/2.42
• US Class Current: 623/2.17
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A prosthetic heart valve having an elastomeric stent with an annular base and a plurality of apertures or holes circumferentially spaced around the base for receiving a suture. Flexible polymeric leaflets are molded over the stent. Polymeric material surrounds the apertures, leaving a central opening in each aperture. The base may be a frustro-conical ring. A sewing ring is mounted on the heart valve by suturing the ring through the apertures. Apertures or holes may also be provided by extending an area covered by woven material around all or part of the circumference of the base.

Claims

1. A prosthetic heart valve having an inside and an outside and comprising:

a polymeric valve body having at least one leaflet, said leaflet having an open position and a closed position,

a stent coupled to said valve body, said stent having a plurality of apertures, said apertures providing openings between the outside of the prosthetic heart valve and the inside of the prosthetic heart valve and said apertures being capable of receiving sewing ring fasteners, wherein said stent comprises a circumferential base and the apertures penetrate said base, wherein at least a portion of the stent is embedded in the polymeric valve body, and wherein said polymeric valve body encloses said base and includes a plurality of apertures in said polymeric valve body corresponding to said apertures in said base.

2. The prosthetic heart valve of claim 1 wherein said stent comprises a plurality of commissures in generally cylindrical configuration and said base is connected to said commissures at an upstream location and said base slants radially outwardly from said commissures.

3. The prosthetic heart valve of claim 2 wherein a junction between said commissures and said base forms an angle of between 90°

and 135°

.

4. The prosthetic heart valve of claim 1 further comprising a sewing ring circumferentially surrounding the base.

5. The prosthetic heart valve of claim 4 wherein said sewing ring is connected to said base at an upstream, inner side of said base.

6. The prosthetic heart valve of claim 1 wherein at least some of said apertures are slots.

7. The prosthetic heart valve of claim 6 wherein at least one of said apertures is generally circular.

8. The prosthetic heart valve of claim 1 further comprising a sewing ring circumferentially surrounding the valve body and the stent and attached to the stent by sewing ring fasteners extended through said apertures in said stent.

9. The prosthetic heart valve of claim 8 wherein the sewing ring fasteners are sutures.

10. The prosthetic heart valve of claim 1, wherein said stent further comprises an upstream edge and a wire connected to said edge wherein the apertures are downstream from said wire.

11. The prosthetic heart valve of claim 10 further comprising a sewing ring circumferentially surrounding the valve body and the stent and attached to the stent by sewing ring fasteners extended through said apertures in said stent.

12. The prosthetic heart valve of claim 11 wherein the sewing ring fasteners are sutures.

13. A prosthetic heart valve comprising:

a polymeric valve body having at least one leaflet, said leaflet having an open position and a closed position,

a stent molded within said valve body, said stent having a plurality of apertures, said apertures being exposed through said polymeric valve body.

14. The prosthetic heart valve of claim 13 wherein said stent comprises a circumferential base and wherein said apertures penetrate said base.

15. The prosthetic heart valve of claim 14 wherein said polymeric valve body encloses said base and includes a plurality of apertures in said polymeric valve body corresponding to said apertures in said base.

16. The prosthetic heart valve of claim 14 wherein said stent comprises a plurality of commissures in generally cylindrical configuration and said base is connected to said commissures at an upstream location and said base slants radially outwardly from said commissures.

17. The prosthetic heart valve of claim 16 wherein a junction between said commissures and said base forms an angle of between 90°

and 135°

.

18. The prosthetic heart valve of claim 14 further comprising a sewing ring circumferentially surrounding the valve body.

19. The prosthetic heart valve of claim 18 wherein said sewing ring is connected to said base at an upstream, inner side of said base.

20. The prosthetic heart valve of claim 14 wherein at least some of said apertures are slots.

21. The prosthetic heart valve of claim 20 wherein at least one of said apertures is generally circular.

22. The prosthetic heart valve of claim 13 further comprising a sewing ring circumferentially surrounding the valve body and the stent and attached to the stent by fasteners extended through said apertures in said stent.

23. The prosthetic heart valve of claim 22 wherein the fasteners are sutures.

24. The prosthetic heart valve of claim 13 wherein said stent further comprises an upstream edge adjacent blood flowing into the valve and a wire connected to said upstream edge wherein the apertures are downstream from said wire.

25. The prosthetic heart valve of claim 24 further comprising a sewing ring circumferentially surrounding the valve body and the stent and attached to the stent by fasteners extended through said apertures in said stent.

26. The prosthetic heart valve of claim 25 wherein the fasteners are sutures.