Tissue heart valve with annulus support structure

• US 7,316,712 B2
• Filed: 06/24/2002
• Issued: 01/08/2008
• Est. Priority Date: 12/30/1999
• Status: Expired due to Fees

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Peredo, Mario Osvaldo Vrandecic
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US10/179,145
• Publication Number:
  US 20020173843A1
• Time in Patent Office: 2,024 Days
• Field of Search: 623 21- 219, 623 236- 241, 623/900, 623/909, 623/915, 623/920, 623/11.11, 623/23.68
• US Class Current: 623/2.13
• 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 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A heart valve prosthesis can be formed with a harvested tissue heart valve and a sewing rim that extends outwardly from the annulus of the harvested heart valve for easier attachment of the prosthesis. The heart valve prosthesis can further include a belt that extends along the annulus to provide further support to the valve annulus. A single piece of pericardial tissue can be used to form the sewing rim, belt and a collar that envelopes the edge of the annulus. The harvested heart valve prosthesis can have the diameter of its annulus adjusted using pledgeted suture prior to the application of additional support structures such as the belt, sewing rim and collar.

Claims

1. A heart valve prosthesis comprising:

a harvested tissue heart valve with integral leaflets, the heart valve having an annulus at one end of the valve, the annulus having a surface;

an exposed belt secured around at least a substantial portion of an outer circumference of the annulus surface of the harvested tissue heart valve; and

a sewing rim adjacent the belt, extending radially outwardly from the annulus, axially positioned between the belt and the annulus and along a side of the annulus.

2. The heart valve prosthesis of claim 1 wherein the belt has a thickness along the annulus surface from about 2 mm to about 3 mm.

3. The heart valve prosthesis of claim 1 wherein the belt has a thickness along the annulus surface of at least about 1.5 mm.

4. The heart valve prosthesis of claim 1 wherein the belt has a thickness along the annulus surface of at least about 2 mm.

5. The heart valve prosthesis of claim 1 wherein the belt comprises rolled up tissue.

6. The heart valve prosthesis of claim 1 wherein the belt comprises pericardial tissue.

7. The heart valve prosthesis of claim 1 wherein the belt comprises pericardial tissue folded over a ring structure.

8. The heart valve prosthesis of claim 1 wherein the belt comprises synthetic material.

9. The heart valve prosthesis of claim 1 wherein the belt extends outwardly from the annulus surface from about 1.5 mm to about 4 mm.

10. The heart valve prosthesis of claim 1 wherein the belt extends outwardly from the annulus surface from about 2 mm to about 3 mm.

11. The heart valve prosthesis of claim 1 wherein the harvested tissue heart valve comprises a harvested xenograft mitral heart valve.

12. The heart valve prosthesis of claim 11 wherein the harvested xenograft mitral heart valve is harvested from a mammal with a heart valve having a size and anatomy similar to a human'"'"'s size and anatomy.

13. The heart valve prosthesis of claim 11 wherein the harvested xenograft mitral heart valve has intact chordae extending from the leaflets and a section of papillary muscle attached at the end of the chordae.

14. The heart valve prosthesis of claim 13 wherein the papillary muscle attached to the chordae is reinforced with a reinforcing patch.

15. The heart valve prosthesis of claim 1 further comprising a collar enveloping the end of the annulus of the harvested tissue heart valve.

16. The heart valve prosthesis of claim 15 wherein the collar comprises xenograft pericardial tissue.

17. The heart valve prosthesis of claim 16 wherein the collar is sutured to an inner surface of the annulus and an outer surface of the annulus.

18. The heart valve prosthesis of claim 15 wherein the collar comprises tissue.

19. The heart valve prosthesis of claim 15 wherein the collar and belt are formed from a single section of integral material.

20. The heart valve prosthesis of claim 19 wherein the integral material comprises pericardial tissue.

21. The heart valve prosthesis of claim 1 wherein the annulus comprises pledgeted suture reducing the circumference of the annulus.

22. The heart valve prosthesis of claim 1 wherein the sewing rim projects at least about 2 mm from the surface of the annulus.

23. The heart valve prosthesis of claim 22 wherein the sewing rim extends from about 2 mm to about 4 mm from the surface of the annulus.

24. The heart valve prosthesis of claim 1 wherein the harvested tissue heart valve comprises homograft tissue.

25. A method of producing a heart valve prosthesis comprising a harvested tissue heart valve with integral leaflets, the heart valve having an annulus at one end of the valve, the annulus having a surface, the method comprising:

attaching an exposed belt around at least a substantial portion of an outer circumference of the annulus surface of the harvested tissue heart valve; and

extending a sewing rim adjacent the belt radially outwardly from the annulus, axially positioning the sewing rim between the belt and the annulus and along a side of the annulus.

26. The method of claim 25 wherein the belt has a thickness along the annulus surface of at least about 1.5 mm.

27. The method of claim 25 wherein the belt is formed from a rolled-up portion of pericardial tissue, the pericardial tissue extending to a collar that envelops the end of the annulus.

28. The method of claim 25 wherein the belt is formed by folding pericardial tissue over a ring structure.