COHERENT SINGLE LAYER HIGH STRENGTH SYNTHETIC POLYMER COMPOSITES FOR PROSTHETIC VALVES

• US 20150224231A1
• Filed: 02/13/2015
• Published: 08/13/2015
• Est. Priority Date: 04/01/2011
• Status: Active Grant

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Gassler, Paul D., Hartman, Cody L., Walsh, Peter J., Finney, Bill R.
• Granted Patent: US 9,801,712 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2472 Devices for testing
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 27/48 with macromolecular fillers
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor

Abstract

Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a prosthetic valve for regulating blood flow direction. In one aspect, the leaflet material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The leaflet material includes a coherent single layer and an elastomer, wherein the elastomer is present in the pores of the porous coherent single layer.

Claims

1. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, the coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that the coherent single layer is impermeable.

2. The prosthetic valve of claim 1, comprising only one coherent single layer.

3. The prosthetic valve of claim 1, wherein the at least one coherent single layer has a microporous structure.

4. The prosthetic valve of claim 1, wherein the at least one coherent single layer is a single ply of porous synthetic polymer membrane.

5. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.

6. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a break force of greater than about 1 N/mm.

7. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet passes a compressive bending test.

8. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a compression set of less than 15%.

9. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a liquid pickup of less than 10%.

10. The prosthetic valve of claim 4, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2.

11. The prosthetic valve of claim 1, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, wherein each ply comprises the same material.

12. The prosthetic valve of claim 1, wherein the at least one coherent single layer includes a plurality of plies of porous synthetic polymer membrane, the plies are bonded together without the use of an additional material.

13. The prosthetic valve of claim 12, wherein each ply is expanded polymer membrane prior to the plies being bonded together.

14. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.

15. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a break force of greater than about 1 N/mm.

16. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet passes a compressive bending test.

17. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a compression set of less than 15%.

18. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet has a liquid pickup of less than 10%.

19. The prosthetic valve of claim 12, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores that have a pore size that is less than about 5 μ

m, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2.

20. The prosthetic valve of claim 11, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies raised above a crystalline melt temperature of the polymer.

21. The prosthetic valve of claim 11, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies then expanded, and the plies raised above a crystalline melt temperature of the polymer.

22. The prosthetic valve of claim 13, wherein the plies are bonded together includes the plies placed in a stacked configuration and the plies then raised above a crystalline melt temperature of the polymer.

23. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein an average diameter of the fibers is less than about 1 μ

m, the space between the fibers defining the pores.

24. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein an average diameter of the fibers is less than 0.1 μ

m, the space between the fibers defining the pores.

25. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 1.0 μ

m, the space between the fibers defining the pores.

26. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises fibers that define space therebetween, wherein a diameter of a majority of the fibers is less than 0.1 μ

m, the space between the fibers defining the pores.

27. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises fibers that define space therebetween, the space between the fibers defining pores that have a pore size that is less than about 5 μ

m.

28. The prosthetic valve of claim 1, wherein the at least one coherent single layer is a fluoropolymer.

29. The prosthetic valve of claim 28, wherein the fluoropolymer is PTFE.

30. The prosthetic valve of claim 29, wherein the PTFE is ePTFE.

31. The prosthetic valve of claim 1, wherein the at least one coherent single layer is porous polyethylene.

32. The prosthetic valve of claim 1, wherein the elastomer is silicone.

33. The prosthetic valve of claim 30, wherein the elastomer is silicone.

34. The prosthetic valve of claim 31, wherein the elastomer is silicone.

35. The prosthetic valve of claim 1, wherein the elastomer is a fluoroelastomer.

36. The prosthetic valve of claim 1, wherein the elastomer is a urethane.

37. The prosthetic valve of claim 30, wherein the elastomer is a TFE/PMVE copolymer.

38. The prosthetic valve of claim 37, wherein the TFE/PMVE copolymer comprises essentially of between about 40 and 80 weight percent perfluoromethyl vinyl ether and complementally 60 and 20 weight percent tetrafluoroethylene.

39. The prosthetic valve of claim 1, wherein the leaflet has a tensile strength in at least two orthogonal directions greater than about 35 MPa.

40. The prosthetic valve of claim 1, wherein the leaflet has a break force of greater than about 1 N/mm.

41. The prosthetic valve of claim 1, wherein the leaflet has a break force of greater than about 2 N/mm.

42. The prosthetic valve of claim 1, wherein the leaflet has a break force of greater than about 3 N/mm.

43. The prosthetic valve of claim 1, wherein the leaflet has a thickness of less than about 350 μ

m.

44. The prosthetic valve of claim 1, wherein the pores have a pore size that is less than 5 μ

m.

45. The prosthetic valve of claim 1, wherein the pores have a pore size that is less than 1 μ

m.

46. The prosthetic valve of claim 1, wherein the pores have a pore size that is less than 0.1 μ

m.

47. The prosthetic valve of claim 1, wherein the at least one coherent single layer comprises substantially only of fibers.

48. The prosthetic valve of claim 47, wherein the fibers define space therebetween, wherein a majority of the fibers has a diameter that is less than 1.0 μ

m.

49. The prosthetic valve of claim 47, wherein the fibers define space therebetween, wherein a majority of the fibers has a diameter that is less than 0.1 μ

m.

50. The prosthetic valve of claim 1, wherein the leaflet comprises elastomer by weight in a range from about 35% to about 90%.

51. The prosthetic valve of claim 1, wherein the at least one coherent single layer is expanded fluoropolymer, wherein the elastomer is a TFE/PMVE copolymer, and wherein the valve is operable to be a prosthetic heart valve.

52. The prosthetic valve of claim 1, wherein the at least one cohesive single layer is porous polyethylene, wherein the elastomer is a silicone, and wherein the valve is operable to be a prosthetic heart valve.

53. The prosthetic valve of claim 1, wherein the at least one coherent single layer is expanded PTFE, wherein the elastomer is a TFE/PMVE copolymer, and wherein the valve is operable to be a prosthetic heart valve.

54. The prosthetic valve of claim 1, wherein the at least one cohesive single layer is PTFE, wherein the elastomer is a silicone, and wherein the valve is operable to be a prosthetic heart valve.

55. The prosthetic valve of claim 1, wherein the frame is selectively diametrically adjustable for endovascular delivery and deployment at a treatment site, wherein the valve is operable to be a prosthetic heart valve.

56. The prosthetic valve of claim 1, wherein the leaflet passes a compressive bending test.

57. The prosthetic valve of claim 1, wherein the leaflet has a compression set of less than 15%.

58. The prosthetic valve of claim 1, wherein the leaflet has a compression set of less than 10%.

59. The prosthetic valve of claim 1, wherein the leaflet has a compression set of less than 5%.

60. The prosthetic valve of claim 1, wherein the leaflet has a light transmission of more than 60% at a 550 μ

m wavelength.

61. The prosthetic valve of claim 1, wherein the leaflet has a light transmission of more than 75% at a 550 μ

m wavelength.

62. The prosthetic valve of claim 1, wherein the leaflet has a light transmission of more than 90% at a 550 μ

m wavelength.

63. The prosthetic valve of claim 1, wherein the leaflet has a liquid pickup of less than 10%.

64. The prosthetic valve of claim 1, wherein the leaflet has a liquid pickup of less than 5%.

65. The prosthetic valve of claim 1, wherein the leaflet has a liquid pickup of less than 3%.

66. The prosthetic valve of claim 1, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 2.

67. The prosthetic valve of claim 1, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.5.

68. The prosthetic valve of claim 1, wherein the leaflet exhibits a ratio of tensile strength in two orthogonal directions of less than 1.3.

69. The prosthetic valve of claim 1, wherein the at least one coherent single layer is a plurality of coherent single layers coupled together via the elastomer therebetween.

70. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer and an elastomer, the coherent single layer has pores and comprises a synthetic polymer, the elastomer present in the pores such that the leaflet has a light transmission of at least 60% at a 550 μ

m wavelength.

71-138. -138. (canceled)

139. A prosthetic valve comprising:

a frame; and

a leaflet coupled to the frame and movable between open and closed positions, the leaflet including at least one coherent single layer comprising a plurality of plies of porous synthetic polymer membrane and an elastomer, each ply has pores and comprises the same material, the plies are bonded together without the use of an additional material, the elastomer present in the pores such that the leaflet is impermeable.

140-198. -198. (canceled)

199. A method of making a prosthetic valve, comprising:

providing a frame;

providing a plurality of leaflets, each leaflet including at least one coherent single layer and an elastomer, the coherent single layer having pores and is a synthetic polymer, the elastomer present in the pores such that the coherent single layer is impermeable; and

coupling the leaflets to the frame such that the leaflets are movable between open and closed positions.

200-218. -218. (canceled)