Biomechanical heart valve prosthesis and method for making same

• US 20010049555A1
• Filed: 03/26/2001
• Published: 12/06/2001
• Est. Priority Date: 05/03/2000
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 6,582,464 B2
• Time in Patent Office: Days
• US Class Current: 623/2.13
• 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

Abstract

A system and method are disclosed for covering a mechanical heart valve with biological tissue to provide a biomechanical heart valve prosthesis. The prosthesis includes a mechanical heart valve having a moveable portion mounted within a generally annular support that permits substantially unidirectional flow of blood therethrough. One or more sheets of a biological tissue material are applied around the support heart valve to provide a sewing ring that includes the biological tissue material.

Claims

1. A heart valve prosthesis, comprising:

a mechanical heart valve having a generally annular support, the mechanical heart valve being operative to permit substantially unidirectional flow of blood through the mechanical heart valve; and

biocompatible biological tissue material disposed around the annular support to define at least part of a sewing ring.

2. The heart valve prosthesis of

claim 1

, further comprising a retaining feature that holds the tissue material at a desired position relative to the annular support.

3. The heart valve prosthesis of

claim 2

, wherein the retaining feature further comprises at least one suture that holds the tissue material at the desired position relative to the annular support.

4. The heart valve prosthesis of

claim 1

, wherein the sewing ring further comprises a generally tubular ring of the biological tissue material that circumscribes the annular support, the generally tubular ring having a radially inner portion that engages an exterior portion of the mechanical heart valve and a radially outer portion that extends from the radially inner portion.

5. The heart valve prosthesis of

claim 4

, further comprising a retaining feature located within an interior of the generally tubular ring, the retaining feature urging the radially inner portion of the generally tubular ring into engagement with the exterior portion of the mechanical heart valve.

6. The heart valve prosthesis of

claim 5

, wherein the retaining feature further comprises a plurality of windings of at least one suture that circumscribe the radially inner portion of the generally tubular ring and the exterior portion of the mechanical heart valve.

7. The heart valve prosthesis of

claim 4

, wherein the generally tubular ring further comprises a pair of annular sheets of the tissue material, each of the annular sheets having a radially inner edge portion and an outer portion spaced outwardly from the respective inner edge portion, the annular sheets being connected together near the respective inner portions and near the respective outer portions to define the generally tubular ring.

8. The heart valve prosthesis of

claim 7

, further comprising a retaining feature located within an interior of the generally tubular ring, the retaining feature urging a radially inner portion of the generally tubular ring into engagement with the exterior portion of the mechanical heart valve.

9. The heart valve prosthesis of

claim 1

, wherein the tissue material further comprises at least one of a treated animal pericardium and collagen.

10. The heart valve prosthesis of

claim 1

, further comprising a fabric material disposed around the annular support to define a fabric sewing ring of the mechanical heart valve, the tissue material being disposed around the annular support and the fabric sewing ring so as to cover externally exposed fabric material.

11. The heart valve prosthesis of

claim 10

, wherein the biological tissue material further comprises a pair of annular sheets of the biocompatible biological tissue material, each of the annular sheets having a radially inner portion and a radially outer portion, the radially outer portions being connected together to define a radially outer extent of the heart valve prosthesis, the radially inner portions being connected to generally axially opposed portions of the fabric sewing ring.

12. The heart valve prosthesis of

claim 1

, further comprising glycerin within the biological tissue material so as to render the tissue generally pliable when stored in a dry condition.

13. A heart valve prosthesis, comprising:

a mechanical heart valve having an annulus and a moveable part supported within the annulus to permit generally unidirectional flow of blood through the mechanical heart valve;

at least one sheet of a treated biological tissue material circumscribing at least part of an exterior portion of the mechanical heart valve;

at least one retaining element operative to attach a radially inner portion of the at least one sheet about the exterior portion of the mechanical heart valve.

14. The heart valve prosthesis of

claim 13

, wherein the retaining element further comprises at least one suture that extends generally circumferentially around the radially inner portion of the at least one sheet and the exterior portion of the mechanical heart valve to maintain engagement therebetween.

15. The heart valve prosthesis of

claim 13

, wherein the at least one sheet further comprises a generally tubular ring of the biological tissue material that circumscribes the mechanical heart valve, the retaining element being located within the tubular ring.

16. The heart valve prosthesis of

claim 13

, wherein the biological tissue material further comprises at least one of treated animal pericardium and collagen.

17. The heart valve prosthesis of

claim 16

, further comprising glycerin in the biological tissue material to render the biological tissue material generally pliable.

18. A heart valve prosthesis, comprising:

a mechanical heart valve having an annular support and a valve member supported within the annular support to permit generally unidirectional flow of blood through the mechanical heart valve;

a sewing ring of a fabric material disposed around the annular support to form a fabric sewing ring; and

at least one sheet of a biocompatible biological tissue material covering externally exposed portions of the fabric material.

19. The heart valve prosthesis of

claim 18

, wherein the biological tissue material further comprises a pair of annular sheets of the biocompatible biological tissue material, each of the annular sheets having a radially inner portion and a radially outer portion, the radially outer portions being connected together to define a radially outer extent of the heart valve prosthesis, the radially inner portions being connected to generally axially opposed portions of the fabric sewing ring so that exposed portions of the fabric material are covered.

20. The heart valve prosthesis of

claim 18

, further comprising glycerin within the biological tissue material so as to render the biological tissue material generally pliable.

21. The heart valve prosthesis of

claim 18

, wherein the biological tissue material further comprises at least one of treated animal pericardium and collagen.

22. A heart valve prosthesis, comprising:

mechanical valve means for permitting substantially unidirectional flow of blood through an annulus thereof;

treated, biocompatible biological tissue means for covering around the annulus of the valve means and for providing a sewing ring to facilitate implantation of the prosthesis; and

means for retaining the tissue means around the valve means.

23. The heart valve prosthesis of

claim 22

, further comprising fabric means mounted circumferentially around the annulus of the valve means, the biological tissue means covering externally exposed portions of the fabric means.

24. The heart valve prosthesis of

claim 23

, wherein the tissue means further comprises a pair of annular means for, when connected around the valve means, forming a biological cover over exposed portions of the fabric means.

25. A method of making a biomechanical heart valve prosthesis, comprising:

providing a mechanical heart valve operative to permit substantially unidirectional flow of blood through the mechanical heart valve; and

applying at least one sheet of a biocompatible biological tissue material around an exterior portion of the mechanical heart valve to provide a sewing ring that includes the biological tissue material.

26. The method of

claim 25

, wherein the mechanical heart valve further includes a sewing ring of a fabric material, the at least one sheet being applied to cover exposed fabric material of the sewing ring.

27. The method of

claim 25

, further comprising applying a pair of annular sheets of the biological tissue material around the mechanical heart valve, at least radially outer edge portions of the pair of annular sheets being connected together to define a radially outer extent of the sewing ring.

28. The method of

claim 27

, further comprising connecting together radially inner portions of the pair of annular sheets to form the generally tubular ring that circumscribes the mechanical heart valve.

29. The method of

claim 28

, wherein, prior to connecting the radially outer portions of the pair of annular sheets together, the method further comprises securing a radially inner portion of an annular member formed of the pair of annular sheets about an exterior portion of the mechanical heart valve.

30. The method of

claim 27

, wherein the mechanical heart valve further comprises a fabric sewing ring of a fabric material mounted about the exterior portion of the mechanical heart valve, the radially inner portion of each of the pair of annular sheets being connected to generally axially opposed portions of the fabric sewing ring, such that exposed fabric material is covered by the pair of annular sheets.

31. The method of

claim 25

, further comprising immersing the biological tissue material in a glycerin solution.

32. The method of

claim 31

, further comprising removing moisture from the biological tissue material and storing the heart valve prosthesis in a substantially dry condition, such that some of the glycerin remains in the biological tissue material to render the biological tissue material generally pliable.

33. The method of

claim 25

, wherein the biological tissue material further comprises at least one of a treated animal pericardium and collagen.

34. A heart valve prosthesis, comprising:

a generally cylindrical support;

a heart valve mounted within the support to permit substantially unidirectional flow of blood through the heart valve; and

at least one sheet of biocompatible biological tissue material mounted around and covering the annular support, one part of the at least one sheet defining a sewing ring.

35. The heart valve prosthesis of

claim 34

, wherein the support further comprises a generally rigid stent having stent posts extending from an annular base portion to define spaced apart inflow and outflow ends of the stent, the heart valve further comprising a natural tissue heart valve mounted within the stent, the natural tissue heart valve having commissures extending generally axially between adjacent leaflets of the natural tissue heart valve, the commissures being axially aligned with associated stent posts, another part of the at least one sheet having inflow and outflow edges that extend beyond the inflow and outflow ends of the stent and substantially coextensive with inflow and outflow ends of the natural tissue heart valve, the inflow and outflow edges of the at least one sheet being attached to the natural tissue heart valve along the inflow and outflow ends of the natural tissue heart valve, such that at least an exterior part of the stent is covered and held in place by the biological tissue material.

36. The heart valve prosthesis of

claim 35

, further comprising fabric material that covers at least an external portion of the stent, the at least one sheet covering the fabric material of the stent.

37. The heart valve prosthesis of

claim 34

, wherein the heart valve is a mechanical heart valve comprising a valve member mounted for movement within the annular support to permit substantially unidirectional flow of blood through the mechanical heart valve.