LEAFLET AND VALVE APPARATUS

• US 20140163671A1
• Filed: 02/18/2014
• Published: 06/12/2014
• Est. Priority Date: 04/01/2011
• Status: Abandoned Application

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Hartman, Cody L.
• Application Number:
  US14/183,251
• Publication Number:
  US 20140163671A1
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61L 2420/04 Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 27/34 Macromolecular materials
• 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: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

The present invention provides a leaflet for use in a prosthetic valve that stabilizes the motion of the leaflet as it moves between a closed position and an open position. In accordance with embodiments, a prosthetic valve is provided with a leaflet that contains a stiffening element between layers of film from which the leaflet is made.

Claims

1. A leaflet for a prosthetic valve, comprising:

a plurality of layers of film coupled together and configured in a form of the leaflet; and

one or more guiding elements coupled between two of the plurality of layers of film, wherein each guiding element is relatively more stiff compared to the plurality of layers of film.

2. The leaflet of claim 1, wherein the one or more guiding elements have a length which is aligned substantially perpendicular to predetermined stress lines corresponding to lines of stress in the leaflet when the leaflet is deployed in the valve and the valve is operated so as to flex the leaflet.

3. The leaflet of claim 1 wherein the one or more guiding elements are spaced a predetermined distance from a frame.

4. The leaflet of claim 1, wherein the leaflet defines a leaflet edge portion and a leaflet base opposite from the leaflet edge portion, and a central portion between the leaflet edge portion and the leaflet base, the guiding element being located in the central portion.

5. The prosthetic valve of claim 4, wherein the guiding element defines a guiding element length and the leaflet defines a leaflet length extending from the leaflet base and the leaflet edge portion, the guiding element length being less than the leaflet length.

6. The prosthetic valve of claim 4, the leaflet further comprising a vertical axis and wherein the guiding element crosses the vertical axis.

7. The prosthetic valve of claim 4, the leaflet further comprising a vertical axis and wherein the guiding element is located substantially coincident with at least a portion of the vertical axis.

8. The prosthetic valve of claim 1, wherein the guiding element is comprised of a shape-memory material.

9. The prosthetic valve of claim 1, wherein the guiding element is comprised of a metallic material.

10. The prosthetic valve of claim 8, wherein the guiding element is comprised of a shape-memory material.

11. The prosthetic valve of claim 8, wherein the guiding element is formed from a wire.

12. The prosthetic valve of claim 8, wherein the leaflet comprises a polymeric material.

13. The prosthetic valve of claim 12, wherein the leaflet is formed from a composite material having more than one fluoropolymer layer.

14. The prosthetic valve of claim 13, wherein the guiding element is located between two fluoropolymer layers.

15. The prosthetic valve of claim 14, wherein the fluoropolymer layers comprise a plurality of pores.

16. The prosthetic valve of claim 15, wherein substantially all of the pores contain an elastomer.

17. The prosthetic valve of claim 16, wherein the elastomer comprises a fluoroelastomer.

18. The prosthetic valve of claim 16, wherein the elastomer comprises a TFE/PMVE copolymer.

19. The prosthetic valve of claim 17, wherein the fluoropolymer comprises PTFE.

20. The prosthetic valve of claim 19, wherein the PTFE is ePTFE.

21. The prosthetic valve of claim 1, wherein the guiding element defines a shape of one of a polygon, a square-sided oval, an undulating shape, a lemniscate, and an S-type shape.

22. A prosthetic valve comprising:

a frame;

at least one leaflet comprising a plurality of layers of film coupled together, each leaflet defining a leaflet base, a leaflet edge portion opposite the leaflet base, and a central portion between the leaflet base and the leaflet edge portion, wherein the leaflet is coupled to the frame along at least a portion of the leaflet base; and

a guiding element coupled between two of the plurality of layers of film that comprise the leaflet, the guiding element being located in the central portion and spaced apart from the frame.

23. The prosthetic valve of claim 22, wherein the guiding element is relatively more stiff compared to the plurality of layers of film.

24. The prosthetic valve of claim 23, wherein the guiding element defines a guiding element length and the leaflet defines a leaflet length extending from the leaflet base and the leaflet edge portion, the guiding element length being less than the leaflet length.

25. The prosthetic valve of claim 23, the leaflet further comprising a vertical axis and wherein the guiding element crosses the vertical axis.

26. The prosthetic valve of claim 23, the leaflet further comprising a vertical axis and wherein the guiding element is located substantially coincident with at least a portion of the vertical axis.

27. The prosthetic valve of claim 22, wherein the leaflet is operable to move between an open position and a closed position, wherein the guiding element is relatively more stiff compared to the plurality of layers of film, wherein a motion of the guiding element between the open position and a closed position carried by the leaflet follows a substantially planar pivoting surface.

28. The prosthetic valve of claim 27, wherein the motion of the central portion of the leaflet between the open position and a closed position substantially follows the guiding element.

29. The prosthetic valve of claim 22, wherein the guiding element is comprised of a shape-memory material.

30. The prosthetic valve of claim 22, wherein the guiding element is comprised of a metallic material.

31. The prosthetic valve of claim 22, wherein the guiding element is comprised of a shape-memory material.

32. The prosthetic valve of claim 22, wherein the guiding element is formed from a wire.

33. The prosthetic valve of claim 22, wherein the leaflet comprises a polymeric material.

34. The prosthetic valve of claim 33, wherein the leaflet is formed from a composite material having more than one fluoropolymer layer.

35. The prosthetic valve of claim 34, wherein the guiding element is located between two fluoropolymer layers.

36. The prosthetic valve of claim 35, wherein the fluoropolymer layers comprise a plurality of pores.

37. The prosthetic valve of claim 36, wherein substantially all of the pores contain an elastomer.

38. The prosthetic valve of claim 37, wherein the elastomer comprises a fluoroelastomer.

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

40. The prosthetic valve of claim 38, wherein the fluoropolymer comprises PTFE.

41. The prosthetic valve of claim 40, wherein the PTFE is ePTFE.

42. The prosthetic valve of claim 37, wherein the guiding element defines a shape of one of a polygon, a square-sided oval, an undulating shape, a lemniscate, and an S-type shape.

43. A prosthetic valve comprising:

a frame; and

at least one leaflet coupled to the frame, each leaflet comprising a plurality of layers of film coupled together, each leaflet defining a leaflet base, a leaflet edge portion opposite the leaflet base, and a central portion between the leaflet base and the leaflet edge portion, wherein the leaflet is coupled to the frame along at least a portion of the leaflet base, wherein each leaflet is pivotable between an open position and a closed position,

wherein the central portion has a greater stiffness than at least one of the leaflet edge portion and the leaflet base.

44. The prosthetic valve of claim 43, wherein an average stiffness varies throughout the central portion.

45. The prosthetic valve of claim 43, wherein an average stiffness varies throughout the central portion whereby the leaflet changes between a substantially concave shape and substantially convex shape as it pivots between the open position and the closed position.

46. The prosthetic valve of claim 43, wherein the stiffness of the central portion is increased relative to the leaflet base and the leaflet edge portion by at least one of an extra layer of film, a fiber, and a filament located between two of the plurality of layers of film that comprise the leaflet.

47. The prosthetic valve of claim 43, further comprising a guiding element coupled between two of the plurality of layers of film that comprise the leaflet, the guiding element being located in the central portion and spaced apart from the frame, the guiding element being relatively more stiff compared to the plurality of layers of film.

48. The prosthetic valve of claim 47, wherein the guiding element is selected from a list consisting of an extra layer of film, a sheet, a fiber, a filament, and a wire.

49. The prosthetic valve of claim 47, wherein the guiding element defines a guiding element length and the leaflet defines a leaflet length extending from the leaflet base and the leaflet edge portion, the guiding element length being less than the leaflet length.

50. The prosthetic valve of claim 47, the leaflet further comprising a vertical axis and wherein the guiding element crosses the vertical axis.

51. The prosthetic valve of claim 47, the leaflet further comprising a vertical axis and wherein the guiding element is located substantially coincident with at least a portion of the vertical axis.

52. The prosthetic valve of claim 47, wherein the guiding element is comprised of a shape-memory material.

53. The prosthetic valve of claim 47, wherein the guiding element is comprised of a metallic material.

54. The prosthetic valve of claim 47, wherein the guiding element is comprised of a shape-memory material.

55. The prosthetic valve of claim 47, wherein the guiding element is formed from a wire.

56. The prosthetic valve of claim 47, wherein the leaflet comprises a polymeric material.

57. The prosthetic valve of claim 56, wherein the leaflet is formed from a composite material having more than one fluoropolymer layer.

58. The prosthetic valve of claim 57, wherein the guiding element is located between two fluoropolymer layers.

59. The prosthetic valve of claim 58, wherein the fluoropolymer layers comprise a plurality of pores.

60. The prosthetic valve of claim 59, wherein substantially all of the pores contain an elastomer.

61. The prosthetic valve of claim 60, wherein the elastomer comprises a fluoroelastomer.

62. The prosthetic valve of claim 60, wherein the elastomer comprises a TFE/PMVE copolymer.

63. The prosthetic valve of claim 61, wherein the fluoropolymer comprises PTFE.

64. The prosthetic valve of claim 63, wherein the PTFE is ePTFE.

65. The prosthetic valve of claim 47, wherein the guiding element defines a shape of one of a polygon, a square-sided oval, an undulating shape, a lemniscate, and an S-type shape.

66. A leaflet for a prosthetic valve, comprising:

a plurality of layers of film coupled together configured in a form of the leaflet; and

one or more guiding elements coupled between two of the plurality of layers of film, the leaflet defining a leaflet edge portion and a leaflet base opposite from the leaflet edge portion and a central portion between the leaflet edge portion and the leaflet base, each guiding element being located in the central portion, the one or more guiding elements having a length which is aligned radiating away from but spaced apart from the leaflet base such that the leaflet pivots substantially from the leaflet base when the leaflet is deployed in the prosthetic valve and the prosthetic valve is operated so as to flex the leaflet.

67. The leaflet of claim 66 wherein the guiding element is relatively more stiff compared to the plurality of layers of film.

68. The leaflet of claim 67 wherein the one or more guiding elements are spaced a predetermined distance from a frame.