Efficient implantation of heart valve prostheses

• US 6,589,279 B1
• Filed: 04/28/2000
• Issued: 07/08/2003
• Est. Priority Date: 04/28/1999
• Status: Expired due to Fees

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Langanki, Danney J., Anderson, Kimberly A.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/561,521
• Time in Patent Office: 1,166 Days
• Field of Search: 623/2.1, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.16, 623/2.17, 623/2.18, 623/2.19
• US Class Current: 623/2.13
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/047 having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/1157 applying the staples radially
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: Y10S 623/904 Heart

Abstract

Tools can be used to assist with the implantation of heart valve prostheses, especially stentless aortic heart valve prostheses. In some embodiments, a heart valve prosthesis includes a plurality of flexible leaflets; a commissure support and a plurality of fasteners inserted into the inner surface of the commissure support and protruding from the outer surface of the commissure support. The fasteners comprise an elongated portion and a tip at an end of the elongated portion. In other embodiments, a heart valve prosthesis includes a plurality of flexible leaflets and a reinforcement secured to an inner surface of a valve commissure support. The reinforcement has an aperture. The heart valve prosthesis and fastener components can be placed into kits. The fasteners can be used to perform improved implantation procedures.

Claims

1. A heart valve prosthesis comprising:

a heart valve including a plurality of flexible leaflets and a commissure support; and

a plurality of fasteners inserted into the inner surface of the commissure support so as to protrude from the outer surface of the commissure support and be engagable with an aortic wall, the fasteners comprising an elongated portion and a tip at an end of the elongated portion.

2. The prosthesis of claim 1 further comprising a reinforcement on the commissure support.

3. The prosthesis of claim 2 wherein the reinforcement comprises an aperture.

4. The prosthesis of claim 3 the reinforcement comprises a plurality of apertures, wherein the tip of each fastener is inserted through one of the apertures and the commissure support.

5. The prosthesis of claim 2 wherein the reinforcement comprises biocompatible synthetic polymers.

6. The prosthesis of claim 1 wherein the tip is tapered.

7. The prosthesis of claim 6 wherein the end of the fastener opposite the tip has a head.

8. The prosthesis of claim 7 wherein the head is larger than the aperture in the reinforcement.

9. The prosthesis of claim 1 wherein the fastener comprises a barb.

10. The prosthesis of claim 1 wherein the prosthesis comprises tissue.

11. The prosthesis of claim 1 wherein the prosthesis comprises a stentless porcine valve.

12. The prosthesis of claim 1 wherein the prosthesis comprises three leaflets, each commissure support having a reinforcement.

13. The prosthesis of claim 1 wherein the fastener comprises a biocompatible material selected from the group consisting of metal, ceramic, synthetic polymers and combinations thereof.

14. A heart valve prosthesis comprising a plurality of flexible leaflets and a reinforcement which is a separate structure distinct from the flexible leaflets and secured to an inner surface of a valve commissure support at the outflow side of the valve, the reinforcement having an aperture.

15. The prosthesis of claim 14 wherein the reinforcement is secured to the commissure support by a biocompatible adhesive.

16. The prosthesis of claim 14 wherein the reinforcement is secured to the commissure support with suture.

17. The prosthesis of claim 14 wherein the reinforcement is secured to the commissure support by a fastener comprising an elongated portion, a tip at the end of the elongated portion and a barb.

18. The prosthesis of claim 17 wherein the end of the fastener opposite the tip has a head.

19. The prosthesis of claim 14 wherein the prosthesis comprises a porcine valve that includes the flexible leaflets.

20. The prosthesis of claim 14 further comprising a fastener inserted through the aperture.

21. The prosthesis of claim 14 wherein the prosthesis comprises three leaflets and at least three reinforcements, each commissure support having one of the reinforcements.

22. The prosthesis of claim 14 wherein the prosthesis comprises three leaflets and three commissure supports wherein the reinforcement provides reinforcement to the three commissure supports and wherein the reinforcement comprises a plurality of apertures.

23. A heart valve prosthesis kit comprising:

a heart valve prosthesis including a plurality of flexible leaflets and commissure supports;

a reinforcement having apertures; and

fasteners, for holding the heart valve prosthesis to the aortic wall distinct from the prosthesis and adapted for insertion through the apertures and through the commissure support so as to engage an aortic wall, the fasteners comprising an elongated portion and a tip on the end of the elongated portion.

24. The kit of claim 23 wherein the prosthesis comprises tissue.

25. The kit of claim 23 wherein the end of the fastener opposite the tip has a head larger than the aperture.

26. The kit of claim 23 wherein the fasteners comprise a barb.

27. The kit of claim 23 wherein the reinforcement is attached to a commissure support.

28. The heart valve prosthesis kit of claim 23 wherein the reinforcement is separate from the prosthesis.