Natural tissue heart valve prosthesis

• US 5,935,163 A
• Filed: 03/31/1998
• Issued: 08/10/1999
• Est. Priority Date: 03/31/1998
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shelhigh, Inc.
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Willse, David H.
• Application Number:
  US09/052,707
• Time in Patent Office: 497 Days
• Field of Search: 623/2, 623/900
• US Class Current: 623/2.14
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body

Abstract

A heart valve prosthesis (88; 128) having a plurality of leaflets (18, 20 and 22; 138, 140 and 142). The valve (10; 130) is covered with a sheath (90; 172) of natural tissue. The sheath (90; 172) extends from an inflow end (12; 132) of the valve (10; 130) beyond an outflow end (14; 134) of the valve (12; 132) to define a plurality of lobes (98, 100 and 102; 182, 184 and 186). A substantially flexible annular ring (60; 162) may be positioned between the sheath (90; 172) and the heart valve (10; 132) to provide additional stability.

Claims

1. A heart valve prosthesis comprising:

a natural tissue heart valve having an inflow end, an outflow end, and a generally cylindrical side wall portion extending between said inflow end and said outflow end, said valve including a plurality of leaflets, each of said leaflets having an associated side wall portion and side edges, adjacent side edges of adjacent said leaflets and adjacent portions of respective said associated side wall portions defining commissures;

an annular ring of a substantially flexible material positioned around said valve wall intermediate said inflow and outflow ends; and

a sheath of natural tissue attached around said valve wall and said ring, said sheath having an inflow end extending beyond said inflow end of said heart valve and defining an implantation flange, said sheath having an outflow end with a plurality of lobes extending beyond said outflow end of said heart valve.

2. The heart valve prosthesis of claim 1 further comprising a sinus formed in said outflow end of said valve between adjacent said commissures.

3. The heart valve prosthesis of claim 2 wherein said outflow end of said sheath follows the contour of each of said sinuses.

4. The heart valve prosthesis of claim 1 wherein said sheath is made of pericardium.

5. The heart valve prosthesis of claim 1 wherein each of said lobes extends a predetermined distance beyond and lateral to each of said commissures at said outflow end of said heart valve.

6. The heart valve prosthesis of claim 5 wherein each of said lobes comprises an ear-shaped flange.

7. The heart valve prosthesis of claim 1 wherein said heart valve comprises a composite heart valve formed of three heart valve leaflets of generally similar size, shape and symmetry, each said leaflet including a valve wall portion having an inflow end, an outflow end and a pair of generally opposed side edges extending between the inflow and outflow ends, said side edges of each of said leaflets being attached to said side edges of adjacent leaflets such that there is substantial coaptation between said leaflets, adjacent side edges of adjacent leaflets defining said commissures, and said valve wall portions of said composite heart valve leaflets defining said side wall portion of said heart valve.

8. The heart valve prosthesis of claim 7 wherein each of said leaflets is a non-coronary leaflet of an aortic heart valve.

9. The heart valve prosthesis of claim 1 wherein said ring comprises a plastic material having a substantially thin side wall portion.

10. The heart valve prosthesis of claim 9 wherein said side wall portion of said ring has a thickness less than about 0.5 mm.

11. The heart valve prosthesis of claim 9 wherein said side wall portion of said ring has a substantially short axial length relative to the axial length of said side wall portion of said heart valve.

12. The heart valve prosthesis of claim 1 wherein said ring comprises a resilient thin wire member.

13. The heart valve prosthesis of claim 1 wherein said ring is sinusoidal with peaks corresponding to the contour of said outflow end of said heart valve, said ring being attached around said heart valve such that the axial length of said ring at said peaks is less than about two-thirds the axial length of said valve along corresponding said commissures.

14. A heart valve prosthesis comprising:

a natural tissue heart valve comprising;

a generally cylindrical side wall portion extending between an inflow end and an outflow end, said side wall portion having an outer surface; and

a plurality of leaflets dispose&

ed within said side wall portion, each of said leaflets having side edges and an associated side wall portion, adjacent side edges of adjacent said leaflets and respective adjacent portions of said associated side wall portions defining commissures;

an outer sheath of natural tissue covers said outer surface of said heart valve, said outer sheath having an outflow end portion extending beyond said outflow end of said heart valve adjacent said commissures to define a plurality of lobes.

15. The heart valve prosthesis of claim 14 wherein said outer sheath further comprises an inflow end portion extending beyond said inflow end of heart valve to define an implantation flange.

16. The heart valve prosthesis of claim 14 further comprising a substantially flexible annular ring positioned around said outer surface of said side wall portion spaced from and intermediate said outflow end of said heart valve, said outer sheath covering said ring and said heart valve.

17. The heart valve prosthesis of claim 16 further comprising sutures to maintain said ring positioned intermediate said inflow and outflow ends of said heart valve.

18. The heart valve prosthesis of claim 17 wherein said sutures secure said ring to said outer sheath.

19. The heart valve prosthesis of claim 17 wherein said sutures secure said ring to said side wall portion of said heart valve.

20. The heart valve prosthesis of claim 16 wherein said ring has a sinusoidal outflow edge corresponding to the contour of said outflow end of said heart valve.

21. The heart valve prosthesis of claim 16 further comprising a second sheath of natural tissue covering said side wall portion of said heart valve intermediate said ring and said heart valve, said second sheath extending between said inflow and outflow ends of said heart valve.

22. The heart valve prosthesis of claim 14 wherein each of said lobes extends a predetermined distance beyond and lateral to each of said commissures at said outflow end of said heart valve.

23. The heart valve prosthesis of claim 22 wherein each of said lobes comprises an ear-shaped flange.

24. The heart valve prosthesis of claim 14 wherein said heart valve comprises a composite heart valve formed of three heart valve leaflets of generally similar size, shape and symmetry, each said leaflet including a valve wall portion having an inflow end, an outflow end and a pair of generally opposed side edges extending between the inflow and outflow ends, said side edges of each of said leaflets being attached to said side edges of adjacent leaflets such that there is substantial coaptation between said leaflets, adjacent side edges of adjacent leaflets and associated valve wall portions defining said commissures, and said valve wall portions of said leaflets defining said side wall portion of said heart valve.

25. A method of making a heart valve prosthesis comprising the steps of:

providing a natural tissue heart valve having an inflow end, an outflow end, a generally cylindrical side wall portion extending between said inflow end and said outflow end, said heart valve including a plurality of leaflets disposed within said side wall portion, each of said leaflets having a pair of side edges and an associated side wall portion, adjacent side edges of adjacent said leaflets and respective adjacent portions of said associated side wall portions defining commissures;

positioning an annular ring of a substantially flexible and resilient material around said side wall portion intermediate said inflow and outflow ends of said heart valve;

covering said annular ring and said outer surface of said heart valve with a sheath of natural tissue, an sheath having an inflow end portion and an outflow end portion; and

extending said outflow end portion of said sheath beyond said outflow end of said heart valve to define a plurality of lobes adjacent said commissures.

26. The method of claim 25 further comprising the step of extending said inflow end portion of said sheath beyond said inflow end of said heart valve to form an annular implantation flange.

27. The method of claim 25 wherein said extending step further comprises extending each of said lobes a predetermined distance beyond and lateral to each of said commissures at said valve outflow end.