Implantable prosthetic valve

• US 6,440,164 B1
• Filed: 10/21/1999
• Issued: 08/27/2002
• Est. Priority Date: 10/21/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: DiMatteo, Kristian, Marshall, Peter
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/425,142
• Time in Patent Office: 1,041 Days
• Field of Search: 623/1.24, 623/1.25, 623/1.26, 623/2.16, 623/2.17, 623/2.18, 604/9
• US Class Current: 623/1.24
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: Y10T 137/7886 Internally extending mount

Abstract

A prosthetic valve for implantation within a fluid conducting lumen within a body includes an elongate generally cylindrical radially collapsible valve body scaffold defining a fluid passageway therethrough for retentive positioning within the lumen. A radially collapsible leaf valve member is supported by the scaffold includes a number of valve leafs deflectable between a closed position restricting fluid flow through the passageway and an open position permitting fluid flow through the passageway. The leaf valve member includes an interior leaf valve frame defining a valve leaf aperture which is sealed by a fluid impermeable non-thrombogenic lining to prevent fluid flow therethrough.

Claims

1. A prosthetic valve for implantation within a fluid conducting lumen within a body, comprising:

an elongate radially-collapsible generally cylindrical body scaffold defining an elongate fluid passageway therethrough; and

a radially-collapsible leaf valve member supported by said scaffold and being deflectable between a closed configuration restricting fluid flow through said passageway and an open configuration permitting fluid flow through said passageway, said leaf valve member including a valve leaf frame defining a valve leaf aperture, said valve leaf aperture sealed by a fluid impermeable non-thrombogenic lining so as to continuously prevent fluid flow through said valve leaf aperture.

2. The prosthetic valve of claim 1, wherein said leaf valve member is flexibly supported for movement between said closed and open configurations.

3. The prosthetic valve of claim 2, wherein said leaf valve member is normally spring biased towards said closed configuration.

4. The prosthetic valve of claim 2, wherein said leaf valve member is normally spring biased towards said open configuration.

5. The prosthetic valve of claim 1, wherein said leaf valve member includes a plurality of valve leafs deflectably supported in registry with said passageway between said closed and open configurations.

6. The prosthetic valve of claim 5, wherein each of said valve leafs is deflectably supported by said scaffold at flexible hinge, whereby said open and closed configurations of said valve are defined downstream of said flexible hinges.

7. The prosthetic valve of claim 6, wherein said leaf valve member includes three valve leafs deflectably supported in registry with said passageway.

8. The prosthetic valve of claim 6, wherein said leaf valve member includes six valve leafs deflectably supported in registry with said passageway.

9. The prosthetic valve of claim 1, wherein said valve leaf cover is formed from a material selected from the group consisting of polyethylene, pellethane, urethane, bovine pericardial tissue, and expanded polytetraflouroethylene.

10. The prosthetic valve of claim 1, wherein said valve leaf covers are coated with a cellular growth-inhibiting drug.

11. The prosthetic valve of claim 1, wherein said valve leaf apertures are covered with cultured tissue cells.

12. The prosthetic valve of claim 11, further including a porous cover supporting said cultured tissue cells.

13. The prosthetic valve of claim 1, wherein said leaf valve member includes first and second valve leafs and diametrically-opposed first and second hinge hubs, said first and second hinge hubs being downstream of said first and second valve leafs from said body scaffold.

14. The prosthetic valve of claim 13, wherein said first and second valve leafs include an arcuate leaf edge extending between said first and second hinge hubs, wherein said arcuate leaf edges of said first and second valve leafs define a closable valve opening therebetween.

15. The prosthetic valve of claim 14, wherein said first valve leaf further includes a first valve leaf frame defined by a distal end of said scaffold and an elongate wire extending in overlying registry across said distal end of said scaffold.

16. The prosthetic valve of claim 1, wherein said valve leaf frame has a length greater than the radius of the implanted scaffold.

17. The prosthetic valve of claim 9, wherein each of said valve leafs includes a first and second opposed major surfaces, said cover being positioned on one of said first and second major surfaces.

18. The prosthetic valve of claim 17, wherein each of said valve leafs is arcuately-formed to provide a convex shape to said second major surface of each of said valve leafs.

19. The prosthetic valve of claim 1, wherein said scaffold includes a first end defining a first opening, and a second end defining a second opening, and wherein said scaffold includes a substantially cylindrical interior face and a substantially cylindrical exterior face, and defining at least one radially-extending scaffold opening communicating between said interior and exterior faces.

20. The prosthetic valve of claim 19, further comprising an elongate generally cylindrical first biocompatible non-thrombogenic liner supported by said scaffold.

21. The prosthetic valve of claim 20, wherein said first liner is positioned on said interior face of said scaffold.

22. The prosthetic valve of claim 20, wherein said first liner is positioned on said exterior face of said scaffold.

23. The prosthetic valve of claim 20, wherein said valve leaf cover is contiguously formed with said first liner.

24. The prosthetic valve of claim 23, wherein said first liner further spans between adjacent valve leafs.

25. The prosthetic valve of claim 20, further including a second biocompatible non-thrombogenic liner positioned on said scaffold opposite said first liner.

26. The prosthetic valve of claim 25, wherein said first and second liners are contiguous across said first end of said scaffold.

27. The prosthetic valve of claim 25, wherein said first and second liners are affixed to each other through said at least one scaffold opening.

28. The prosthetic valve of claim 1, wherein said scaffold includes at least one radially outwardly projecting hook member for retentively engaging said fluid conduit.

29. The prosthetic valve of claim 1, wherein said scaffold and said leaf valve member are expandable from a first diameter permitting delivery of said prosthetic through said fluid conduit to a second radially-expanded diameter for retentively engaging said fluid conduit.

30. The prosthetic valve of claim 29, wherein said scaffold is radially self-expanding.

31. The prosthetic valve of claim 9, wherein said frame and said scaffold are formed as a unitary support trellis.

32. The prosthetic valve of claim 31, wherein said trellis is formed by a single undulating wire.

33. The prosthetic valve of claim 31, wherein said support trellis further comprises an elongate wire member undulatingly bent to define first one of said valve leaf frame apertures and then said at least one body scaffold aperture.

34. The prosthetic valve of claim 25, wherein at least one of said first and second liner is formed from a material selected from the group consisting of polymer, textile, and bovine cardial tissue.

35. The prosthetic valve of claim 17, wherein each said valve leaf includes elongate first and second edges, said first and second edges of each valve leaf being positionable in abutting fluid-tight engagement with one of said first and second edges of an adjacent valve leaf to define said closed configuration of said valve.

36. The prosthetic valve of claim 1, further including a second radially collapsible open tubular scaffold having a cylindrical inner surface and an opposing cylindrical outer surface, said inner surface defining an elongate fluid conduit being substantially coaxially-aligned with said passageway of said valve, said second scaffold affixed to said body scaffold and extending at least one of said upstream and downstream direction from said valve.

37. The prosthetic valve of claim 36, wherein said second scaffold former includes a biocompatible fluid impermeable non-thrombogenic lining on at least one of said inner surface and said outer surface.

38. The prosthetic valve of claim 31, wherein said trellis is formed from a metal.

39. The prosthetic valve of claim 38, wherein said trellis is an alloy of nitinol.

40. The prosthetic valve of claim 31, wherein said trellis is formed of a polymeric material.

41. The prosthetic valve of claim 40, wherein said polymeric material is bioabsorbable.

42. The prosthetic valve of claim 9, wherein each said valve leaf frame aperture is sealed by organic tissue cultured thereinto.

43. The prosthetic valve of claim 9, wherein each said valve leaf further comprises a fluid-impermeable biocompatible non-thrombogenic valve liner spanning said valve leaf frame aperture.

44. The prosthetic valve of claim 43, wherein each said valve leaf further comprises a second fluid-impermeable biocompatible non-thrombogenic valve liner enclosing said leaf valve frame aperture.

45. The prosthetic valve of claim 44, wherein said first valve liner and said second valve liner for each said valve leaf are laminated together through said leaf valve frame aperture.

46. The prosthetic valve of claim 44, wherein said first valve liner and said second valve liner encase said valve leaf frame.

47. The prosthetic valve of claim 43, wherein said first valve liner of each said valve leaf includes a valve liner flap extending past said perimetrical edge from said first major surface.

48. The prosthetic of claim 47, wherein said valve liner flap of each said valve leaf envelops said leaf valve frame and is laminated through said leaf valve aperture to said first valve liner.