Prosthetic heart valve with slit stent

• US 6,936,067 B2
• Filed: 05/17/2001
• Issued: 08/30/2005
• Est. Priority Date: 05/17/2001
• Status: Expired due to Term

• Current Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Buchanan, Eric S.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US09/860,092
• Publication Number:
  US 20020173842A1
• Time in Patent Office: 1,566 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.12, 623/2.13, 623/2.14, 623/2.15, 623/2.17, 623/2.18, 623/2.19, 623/2.23, 623/2.28, 623/2.33, 623/1.24, 623/1.26, 623/900
• US Class Current: 623/2.28
• 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 valve prosthesis includes a plurality of flexible leaflets and a stent having a central lumen. A slit in the stent extends from the central lumen to an outer surface. An occluding portion of the flexible leaflets extends across the central lumen and an attachment portion extends from the central lumen through the slit and forms a sewing cuff for attachment to a patient'"'"'s tissue. The attachment portion forms a sewing cuff for attachment to native heart tissue.

Claims

1. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and a portion of at least one of the flexible leaflets slidably extends through the slit from the central lumen to the outer surface, the at least one flexible leaflet having an attachment portion, the attachment portion having a rolled rim positioned entirely outside the outer surface of the stent.

2. The valve prosthesis of claim 1 wherein the plurality of flexible leaflets comprises three leaflets.

3. The valve prosthesis of claim 1 wherein the flexible leaflets comprise tissue.

4. The valve prosthesis of claim 1 wherein the flexible leaflets comprise crosslinked tissue.

5. The valve prosthesis of claim 1 wherein the flexible leaflets comprise a polymer.

6. The valve prosthesis of claim 1 wherein the stent comprises a polyacetal.

7. The valve prosthesis of claim 1 wherein the stent comprises a polymer.

8. The valve prosthesis of claim 1 wherein the stent comprises a metal or metal alloy.

9. The valve prosthesis of claim 1 wherein the stent has a plurality of commissure posts connected by scallops.

10. The valve prosthesis of claim 9 wherein the slit extends along one of the scallops at least about 95 percent of the distance between two adjacent commissure posts.

11. The valve prosthesis of claim 1 further comprising a sewing cuff around at least a portion of the circumference of the valve prosthesis.

12. The valve prosthesis of claim 1 wherein the attachment portion of the leaflet is folded on itself and secured to itself to thereby form a suture cuff.

13. The valve prosthesis of claim 1 wherein the attachment portion of the leaflet is wound around a core to thereby form a suture cuff.

14. The valve prosthesis of claim 13 wherein the core comprises a polymer.

15. The valve prosthesis of claim 13 wherein the core comprises fabric.

16. The valve prosthesis of claim 13 wherein the core comprises silicone.

17. The valve prosthesis of claim 1 wherein the attachment portion of the leaflet is configured to attach to a tissue annulus of the heart and distribute stress during valve operation to the aortic wall.

18. The valve prosthesis of claim 1 wherein the stent provides support to the leaflets during implantation.

19. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, at least one flexible leaflet slidably extending through the silt to position a rolled rim of an attachment portion of the flexible leaflet outside the outer surface of the stent and a valve portion of the leaflet in the central lumen.

20. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and an attachment portion of at least one of the flexible leaflets extends from the central lumen through the slit proximate to the outer surface, wherein the attachment portion of the leaflet extending through the slit on the outer portion of the stent is folded on itself and secured to itself to thereby form a suture cuff.

21. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a ventral lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and an attachment portion of at least one of the flexible leaflets extends from the central lumen through the slit proximate to the outer surface, wherein the attachment portion of the leaflet extending through the slit is wound around a core to thereby form a suture cuff.

22. The valve prosthesis of claim 21 wherein the core comprises a polymer.

23. The valve prosthesis of claim 21 wherein the core comprises fabric.

24. The valve prosthesis of claim 21 wherein the core comprises silicone.

25. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and an attachment portion of at least one of the flexible leaflets slidably extends through the slit from the central lumen to the outer surface, wherein the attachment portion of the leaflet extending through the silt on the outer portion of the stent is folded on itself and secured to itself to thereby form a suture cuff.

26. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and an attachment portion of at least one of the flexible leaflets slidably extends through the slit from the central lumen to the outer surface, wherein the attachment portion of the leaflet extending through the slit is wound around a core to thereby form a suture cuff.

27. The valve prosthesis of claim 26 wherein the core comprises a polymer.

28. The valve prosthesis of claim 26 wherein the core comprises fabric.

29. The valve prosthesis of claim 26 wherein the core comprises silicone.

30. The valve prosthesis of claim 26 wherein the flexible leaflets comprise a material selected from the group consisting of tissue, crosslinked tissue, and polymeric materials.

31. The valve prosthesis of claim 26 wherein the stent comprises a polymer, a polyacetal, a metal or a metal alloy.

32. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and a portion of at least one of the flexible leaflets slidably extends through the slit from the central lumen to the outer surface, the at least one flexible leaflet having an attachment portion positioned outside the outer surface, wherein the attachment portion of the flexible leaflet is movable relative to the stent, and wherein the attachment portion of the leaflet extending through the slit on the outer portion of the stent is folded on itself and secured to itself to thereby form a suture cuff.

33. A valve prosthesis comprising a plurality of flexible leaflets and a stent having a central lumen, an outer surface and a slit extending from the central lumen to the outer surface, an occluding portion of the flexible leaflets extending across the central lumen, wherein the flexible leaflets are supported by the stent and a portion of at least one of the flexible leaflets slidably extends through the silt from the central lumen to the outer surface, the at least one flexible leaflet having an attachment portion positioned outside the outer surface, wherein the attachment portion of the flexible leaflet is movable relative to the stent, and wherein the attachment portion of the leaflet extending through the-silt is wound around a core to thereby form a suture cuff.

34. The valve prosthesis of claim 33 wherein the core comprises a polymer.

35. The valve prosthesis of claim 33 wherein the core comprises fabric.

36. The valve prosthesis of claim 33 wherein the core comprises silicone.

37. The valve prosthesis of claim 33 wherein the flexible leaflets comprise a material selected from the group consisting of tissue, crosslinked tissue, and polymeric materials.

38. The valve prosthesis of claim 33 wherein the stent comprises a polymer, a polyacetal, a metal or a metal alloy.

39. A valve prosthesis comprising:

a stent having a central lumen and an outer surface;

leaflet means slidably extending through the stent from the central lumen to the outer surface for blocking blood flow in one direction through the stent; and

attachment means formed from the leaflet means for attaching the leaflet

means to a native tissue annulus of a heart, wherein the attachment

means comprises a rolled rim located entirely outside the outer surface of the stent.