PROSTHETIC VALVES WITH MECHANICALLY COUPLED LEAFLETS

• US 20160175096A1
• Filed: 12/17/2015
• Published: 06/23/2016
• Est. Priority Date: 12/18/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Dienno, Dustin V., Dunham, Michael G., Hartman, Cody L.
• Granted Patent: US 9,855,141 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2220/0083 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with apertures located within the leaflet attachment region of a leaflet. Some embodiments are further directed toward pulmonary valved conduits incorporating such leaflet and leaflet frame constructs. Methods of making and using such prosthetic valve devices are also described amongst others.

Claims

1. A prosthetic valve comprising:

a leaflet frame defining an annular shape having a leaflet frame inner surface, a leaflet frame outer surface opposite the leaflet frame inner surface, and at least two leaflet frame edges extending between the leaflet frame inner surface and the leaflet frame outer surface,

the leaflet frame having a plurality of leaflet frame projections extending from each of one or more leaflet retention surfaces, wherein each leaflet frame projection includes a projection base portion and a projection head portion opposite the projection base portion, the plurality of leaflet frame projections being spaced apart from each other; and

one or more leaflets, each leaflet having a leaflet attachment region and a leaflet free edge,

wherein the one or more leaflet retention surfaces includes at least a portion of the one or more of the leaflet frame edges, wherein each leaflet frame projection is coupled to the leaflet retention surface at the projection base portion, wherein each of the leaflet frame projections extends at least partially through the leaflet attachment region, and wherein the leaflets are retained on the leaflet frame.

2. The prosthetic valve of claim 1, further comprising a restraining element configured to provide a mechanical interference to impede decoupling of a respective leaflet from a respective leaflet frame projection.

3. The prosthetic valve of claim 1, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other such that each of the leaflet frame projections extends through a corresponding one of the plurality of leaflet apertures.

4. The prosthetic valve of claim 2, wherein the restraining element is integral to each of the leaflet frame projections.

5. The prosthetic valve of claim 4, wherein the restraining element includes the projection head portion.

6. The prosthetic valve of claim 5, wherein a transverse dimension of the projection head portion is greater than a transverse dimension of the projection base portion.

7. The prosthetic valve of claim 1, wherein a distance between adjacent leaflet frame projections is less than 2 mm.

8. The prosthetic valve of claim 1, wherein a distance between adjacent leaflet frame projections is at least 0.5 mm.

9. The prosthetic valve of claim 1, wherein the plurality of leaflet frame projections are unitary with the leaflet frame.

10. The prosthetic valve of claim 1, wherein the leaflet frame has a leaflet frame first edge, a leaflet frame second edge opposite the leaflet frame first edge, and optionally at least one leaflet frame internal edge, and wherein the leaflet retention surface is one or more of the leaflet frame second edge, the leaflet frame first edge, and the at least one leaflet frame internal edge.

11. The prosthetic valve of claim 10, wherein a leaflet retention surface is the leaflet frame second edge.

12. The prosthetic valve of claim 10, wherein the leaflet frame has a plurality of commissure posts and a set of leaflet window frame elements flanking each side of each commissure post, wherein each set of leaflet window frame elements and two of the plurality of commissure posts defines one of a plurality of leaflet windows.

13. The prosthetic valve of claim 12, wherein each commissure post has a post slot therethrough, wherein a portion of the leaflet attachment region that is adjacent to the leaflet free edge extends through the post slot adjacent thereto such that a portion of two leaflets extends through each post slot.

14. The prosthetic valve of claim 13, wherein the set of leaflet window frame elements includes two leaflet window sides and a leaflet window base therebetween.

15. The prosthetic valve of claim 14, wherein the leaflet window sides each define a side receiving slot therethrough and the leaflet window base defines a base receiving slot, wherein the leaflet window sides includes a portion of the leaflet retention surface and wherein the leaflet window base includes a portion of the leaflet retention surface, and where a first portion of the leaflet attachment region extends through one of the two side receiving slots with respective leaflet frame projections extending through the leaflet attachment region, a second portion of the leaflet attachment region extends through the other of the two side receiving slots with respective leaflet frame projections extending through the leaflet attachment region, and a third portion of the leaflet attachment region extends through the base receiving slot with respective leaflet frame projections extending through the leaflet attachment region.

16. The prosthetic valve of claim 15, wherein the leaflet attachment region defines one or more notches.

17. The prosthetic valve of claim 15, wherein the leaflet retention surface is the leaflet frame second edge.

18. The prosthetic valve of claim 15, wherein the one or more of the leaflet window frame elements defines a leaflet frame opening therethrough that is adjacent to the respective receiving slot and is on the side opposite from the leaflet frame second edge, wherein the leaflet retention surfaces includes a portion of the leaflet frame internal edge defining each leaflet frame opening.

19. The prosthetic valve of claim 15, wherein the set of leaflet window frame elements together define three sides of an isosceles trapezoid, wherein the leaflet window base defines a leaflet window base second edge that is substantially straight.

20. The prosthetic valve of claim 1, wherein the leaflet is formed of a leaflet material that is reinforced at the leaflet attachment region.

21. The prosthetic valve of claim 1, wherein the leaflet frame projections extend in a direction that is substantially parallel with a central longitudinal axis of the prosthetic valve.

22. The prosthetic valve of claim 21, further comprising a leaflet frame jacket coupled to the leaflet frame and having a lip that projects inward and is configured to impede the leaflets decoupling from the leaflet frame.

23. The prosthetic valve of claim 22, wherein the lip defines one or more recesses into which the leaflet frame projections extend.

24. The prosthetic valve of claim 1, wherein the leaflet frame projections extend in a direction that is substantially normal to the leaflet retention surface.

25. The prosthetic valve of claim 1, wherein each leaflet is extendible substantially perpendicular from a leaflet frame inner surface such that each leaflet is biased towards a closed position.

26. The prosthetic valve of claim 2, wherein the restraining element is a deformable locking bar restraining element comprising:

a deformable locking bar including a bar base end and a bar free end opposite the bar base end, the deformable locking bar extending from the leaflet retention surface at the bar base end, the deformable locking bar having a length that spans a distance between the bar base end and at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

27. The prosthetic valve of claim 26, wherein the locking bar is coupled with the at least one leaflet frame projection.

28. The prosthetic valve of claim 26, further comprising a locking clip coupled to the leaflet retention surface, wherein the locking clip is operable to couple with the bar free end, the deformable locking bar having a length that spans a distance between the bar base end and the locking clip, wherein at least one leaflet frame projection is located between the bar base end and the locking clip, wherein the deformable locking bar extends over the at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

29. The prosthetic valve of claim 28, wherein the locking clip includes a clip groove operable to receive and retain the bar free end therein so as to couple the deformable locking bar to the locking clip.

30. The prosthetic valve of claim 2, wherein the restraining element is an attachable locking bar restraining element comprising:

an attachable locking bar including a bar-shaped element, the attachable locking bar having a length that spans a distance between at least two leaflet frame projections, wherein the attachable locking bar extends over the at least two leaflet frame projections and coupled thereto so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

31. The prosthetic valve of claim 2, wherein the restraining element is an attachable locking bar restraining element comprising:

an attachable locking bar including a bar-shaped element with a retention hook at each end; and

a pair of locking clips spaced apart and coupled to the leaflet retention surface, wherein each of the locking clips is operable to couple with a respective retention hook of the locking bar, the attachable locking bar having a length that spans a distance between the pair of locking clips, wherein at least one leaflet frame projection is located between the pair of locking clips, wherein the attachable locking bar extends over the projection head portion of the at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

32. The prosthetic valve of claim 31, wherein each of the retention hooks defines a C shape operable to receive a portion of the locking clip therein, wherein each retention hook defines a retention flange operable to retain the portion of the locking clip within the retention hook.

33. The prosthetic valve of claim 32, wherein each of the locking clips includes a clip groove operable to receive and retain a portion of the bar-shaped element that is adjacent the retention hook therein so as to couple the deformable locking bar to the locking clip by capturing the locking clip between the bar-shaped element and the retention hook.

34. The prosthetic valve of claim 1, wherein the leaflet frame projections comprise a shape memory material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.

35. The prosthetic valve of claim 1, wherein the leaflet frame projections comprise a plastically deformable material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape by plastically deforming that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.

36. The prosthetic valve of claim 1, wherein the leaflet frame is operable to have one diameter suitable for use as a surgical prosthetic valve.

37. The prosthetic valve of claim 1, wherein the leaflet frame is operable to have a first diameter and a second diameter that is larger than the first diameter suitable for use as a transcatheter prosthetic valve.

38. The prosthetic valve of claim 37, wherein when the leaflet frame is at the first diameter opposing leaflet frame projections abut each other so as to prevent further compression of the leaflet frame elements preventing the crushing of the leaflet.

39. The prosthetic valve of claim 38, wherein when the leaflet frame is at the first diameter opposing leaflet frame projections are in a staggered configuration with respect to each other so as to prevent abutment therebetween so as to minimize the first diameter of the leaflet frame.

40. The prosthetic valve of claim 26, wherein the leaflet frame has a plurality of commissure posts, wherein the plurality of commissure posts include a portion of the leaflet frame edges having the leaflet retention surface from which the deformable locking bar restraining element and a plurality of the leaflet frame projections extend.

41. The prosthetic valve of claim 31, wherein the leaflet frame has a plurality of commissure posts, wherein the plurality of commissure posts include a portion of the leaflet frame edges having the leaflet retention surface from which the attachable locking bar restraining element and a plurality of the leaflet frame projections extend.

42. The prosthetic valve of claim 2, wherein the restraining element is a cap that covers at least a portion of one or more leaflet frame projections suitable to impede decoupling of the leaflet attachment region from the one or more leaflet frame projections.

43. The prosthetic valve of claim 1, wherein the leaflet comprises a material that is synthetic or of animal origin.

44. The prosthetic valve of claim 1, wherein the leaflet comprises at least one fluoropolymer membrane layer.

45. The prosthetic valve of claim 44, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

46. The prosthetic valve of claim 44, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

47. The prosthetic valve of claim 46, wherein an elastomer is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both sides of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

48. The prosthetic valve of claim 47, wherein the elastomer comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

49. The prosthetic valve of claim 47, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

50. The prosthetic valve of claim 1, wherein the leaflet frame comprises at least one of a metal and a polymer.

51. The prosthetic valve of claim 1, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in the pores of at least one of the fluoropolymer membrane layers.

52. The prosthetic valve of claim 51, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

53. The prosthetic valve of claim 51, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

54. The prosthetic valve of claim 51, wherein the fluoropolymer membrane layer comprises ePTFE.

55. The prosthetic valve of claim 51, wherein the elastomer is silicone.

56. The prosthetic valve of claim 51, wherein the elastomer is a fluoroelastomer.

57. The prosthetic valve of claim 51, wherein the elastomer is a urethane.

58. The prosthetic valve of claim 51, wherein the elastomer is a TFE/PMVE copolymer.

59. The prosthetic valve of claim 58, 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.

60. A prosthetic valve comprising:

a plurality of leaflets, each leaflet having a leaflet attachment region; and

a leaflet frame defining an annular shape having one or more leaflet frame edges,

the leaflet frame having a plurality of leaflet frame projections extending from at least one of the leaflet frame edges, each of the leaflet frame projections extending at least partially through the leaflet attachment region; and

one or more restraining elements configured to impede decoupling of the leaflets from the leaflet frame.

61. The prosthetic valve of claim 60, wherein the leaflet attachment region defines a plurality of leaflet apertures spaced apart from each other, each of the leaflet frame projections extending at least partially through a corresponding one of the plurality of leaflet apertures, wherein the one or more restraining elements are coupled to or unitary with the leaflet frame projections configured to impede decoupling of the leaflets from the leaflet frame.

62. The prosthetic valve of claim 61, wherein the restraining element is integral to each of the leaflet frame projections.

63. The prosthetic valve of claim 62, wherein the restraining element includes the projection head portion.

64. The prosthetic valve of claim 63, wherein a transverse dimension of the projection head portion is greater than a transverse dimension of the projection base portion.

65. The prosthetic valve of claim 60, wherein a distance between adjacent leaflet frame projections is less than 2 mm.

66. The prosthetic valve of claim 60, wherein a distance between adjacent leaflet frame projections is at least 0.5 mm.

67. The prosthetic valve of claim 60, wherein the plurality of leaflet frame projections are unitary with the leaflet frame.

68. The prosthetic valve of claim 60, wherein the leaflet frame has a leaflet frame first edge, a leaflet frame second edge opposite the leaflet frame first edge, and optionally at least one leaflet frame internal edge, and wherein the leaflet retention surface is one or more of the leaflet frame second edge, the leaflet frame first edge, and the at least one leaflet frame internal edge.

69. The prosthetic valve of claim 68, wherein a leaflet retention surface is the leaflet frame second edge.

70. The prosthetic valve of claim 68, wherein the leaflet frame has a plurality of commissure posts and a set of leaflet window frame elements flanking each side of each commissure post, wherein each set of leaflet window frame elements and two of the plurality of commissure posts defines one of a plurality of leaflet windows.

71. The prosthetic valve of claim 70, wherein each commissure post has a post slot therethrough, wherein a portion of the leaflet attachment region that is adjacent to the leaflet free edge extends through the post slot adjacent thereto such that a portion of two leaflets extends through each post slot.

72. The prosthetic valve of claim 71, wherein the set of leaflet window frame elements includes two leaflet window sides and a leaflet window base therebetween.

73. The prosthetic valve of claim 72, wherein the leaflet window sides each define a side receiving slot therethrough and the leaflet window base defines a base receiving slot, wherein the leaflet window sides includes a portion of the leaflet retention surface and wherein the leaflet window base includes a portion of the leaflet retention surface, and where a first portion of the leaflet attachment region extends through one of the two side receiving slots with respective leaflet frame projections extending through the leaflet attachment region, a second portion of the leaflet attachment region extends through the other of the two side receiving slots with respective leaflet frame projections extending through the leaflet attachment region, and a third portion of the leaflet attachment region extends through the base receiving slot with respective leaflet frame projections extending through the leaflet attachment region.

74. The prosthetic valve of claim 73, wherein the leaflet attachment region defines one or more notches.

75. The prosthetic valve of claim 73, wherein the leaflet retention surface is the leaflet frame second edge.

76. The prosthetic valve of claim 73, wherein the one or more of the leaflet window frame elements defines a leaflet frame opening therethrough that is adjacent to the respective receiving slot and is on the side opposite from the leaflet frame second edge, wherein the leaflet retention surfaces includes a portion of the leaflet frame internal edge defining each leaflet frame opening.

77. The prosthetic valve of claim 73, wherein the set of leaflet window frame elements together define three sides of an isosceles trapezoid, wherein the leaflet window base defines a leaflet window base second edge that is substantially straight.

78. The prosthetic valve of claim 60, wherein the leaflet is formed of a leaflet material that is reinforced at the leaflet attachment region.

79. The prosthetic valve of claim 60, wherein the leaflet frame projections extend in a direction that is substantially parallel with a central longitudinal axis of the prosthetic valve.

82. The prosthetic valve of claim 60, wherein the leaflet frame projections extend in a direction that is substantially normal to the leaflet retention surface.

83. The prosthetic valve of claim 60, wherein each leaflet is extendible substantially perpendicular from a leaflet frame inner surface such that each leaflet is biased towards a closed position.

84. The prosthetic valve of claim 61, wherein the restraining element is a deformable locking bar restraining element comprising:

a deformable locking bar including a bar base end and a bar free end opposite the bar base end, the deformable locking bar extending from the leaflet retention surface at the bar base end, the deformable locking bar having a length that spans a distance between the bar base end and at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

85. The prosthetic valve of claim 84, wherein the locking bar is coupled with the at least one leaflet frame projection.

86. The prosthetic valve of claim 84, further comprising a locking clip coupled to the leaflet retention surface, wherein the locking clip is operable to couple with the bar free end, the deformable locking bar having a length that spans a distance between the bar base end and the locking clip, wherein at least one leaflet frame projection is located between the bar base end and the locking clip, wherein the deformable locking bar extends over the at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

87. The prosthetic valve of claim 86, wherein the locking clip includes a clip groove operable to receive and retain the bar free end therein so as to couple the deformable locking bar to the locking clip.

88. The prosthetic valve of claim 61, wherein the restraining element is an attachable locking bar restraining element comprising:

an attachable locking bar including a bar-shaped element, the attachable locking bar having a length that spans a distance between at least two leaflet frame projections, wherein the attachable locking bar extends over the at least two leaflet frame projections and coupled thereto so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

89. The prosthetic valve of claim 61, wherein the restraining element is an attachable locking bar restraining element comprising:

an attachable locking bar including a bar-shaped element with a retention hook at each end; and

a pair of locking clips spaced apart and coupled to the leaflet retention surface, wherein each of the locking clips is operable to couple with a respective retention hook of the locking bar, the attachable locking bar having a length that spans a distance between the pair of locking clips, wherein at least one leaflet frame projection is located between the pair of locking clips, wherein the attachable locking bar extends over the projection head portion of the at least one leaflet frame projection so as to impede decoupling of a respective leaflet from the respective leaflet frame projections.

90. The prosthetic valve of claim 89, wherein each of the retention hooks defines a C shape operable to receive a portion of the locking clip therein, wherein each retention hook defines a retention flange operable to retain the portion of the locking clip within the retention hook.

91. The prosthetic valve of claim 90, wherein each of the locking clips includes a clip groove operable to receive and retain a portion of the bar-shaped element that is adjacent the retention hook therein so as to couple the deformable locking bar to the locking clip by capturing the locking clip between the bar-shaped element and the retention hook.

92. The prosthetic valve of claim 60, wherein the leaflet frame projections comprise a shape memory material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.

93. The prosthetic valve of claim 60, wherein the leaflet frame projections comprise a plastically deformable material, wherein the leaflet frame projections define a first shape suitable to allow the advancement of the leaflet attachment region onto the leaflet frame projections and wherein the leaflet frame projections define a second shape by plastically deforming that is suitable to impede decoupling of the leaflet attachment region from the leaflet frame projections.

94. The prosthetic valve of claim 60, wherein the leaflet frame is operable to have one diameter suitable for use as a surgical prosthetic valve.

95. The prosthetic valve of claim 60, wherein the leaflet frame is operable to have a first diameter and a second diameter that is larger than the first diameter suitable for use as a transcatheter prosthetic valve.

96. The prosthetic valve of claim 95, wherein when the leaflet frame is at the first diameter opposing leaflet frame projections abut each other so as to prevent further compression of the leaflet frame elements preventing the crushing of the leaflet.

97. The prosthetic valve of claim 96, wherein when the leaflet frame is at the first diameter opposing leaflet frame projections are in a staggered configuration with respect to each other so as to prevent abutment therebetween so as to minimize the first diameter of the leaflet frame.

98. The prosthetic valve of claim 84, wherein the leaflet frame has a plurality of commissure posts, wherein the plurality of commissure posts include a portion of the leaflet frame edges having the leaflet retention surface from which the deformable locking bar restraining element and a plurality of the leaflet frame projections extend.

99. The prosthetic valve of claim 89, wherein the leaflet frame has a plurality of commissure posts, wherein the plurality of commissure posts include a portion of the leaflet frame edges having the leaflet retention surface from which the attachable locking bar restraining element and a plurality of the leaflet frame projections extend.

100. The prosthetic valve of claim 61, wherein the restraining element is a cap that covers at least a portion of one or more leaflet frame projections suitable to impede decoupling of the leaflet attachment region from the one or more leaflet frame projections.

101. The prosthetic valve of claim 60, wherein the leaflet comprises a material that is synthetic or of animal origin.

102. The prosthetic valve of claim 60, wherein the leaflet comprises at least one fluoropolymer membrane layer.

103. The prosthetic valve of claim 60, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in the pores of at least one of the fluoropolymer membrane layers.

81. The prosthetic valve of claim 79, further comprising a leaflet frame jacket coupled to the leaflet frame and having a lip that projects inward and is configured to impede the leaflets decoupling from the leaflet frame.

81-1. The prosthetic valve of claim 80, wherein the lip defines one or more recesses into which the leaflet frame projections extend.