Valved conduit

• US 10,507,101 B2
• Filed: 10/12/2015
• Issued: 12/17/2019
• Est. Priority Date: 10/13/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Armstrong, Joseph R., Bennett, Nathan L., Colavito, Kyle W., Field, Edwin W.
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/881,124
• Publication Number:
  US 20160100939A1
• Time in Patent Office: 1,527 Days
• 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
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Valved conduits are provided that include a leaflet construct coupled between two portions of a conduit. Each leaflet has a free edge and a leaflet attachment edge. The leaflet attachment edge is disposed between a first conduit distal end and a second conduit proximal end that are coaxial therebetween defining a junction.

Claims

1. A valved conduit comprising:

a conduit including a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, the conduit has a conduit inner surface and a conduit outer surface the first conduit distal end defining a plurality of commissure slots; and

a valve structure including at least one leaflet, each leaflet having a free edge and a leaflet attachment edge, the leaflet attachment edge disposed between the first conduit distal end and the second conduit proximal end that are coaxial therebetween defining a junction,

wherein the leaflet attachment edge is coupled between the first conduit distal end and the second conduit proximal end,

wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture,

wherein the first conduit distal end comprises a plurality of first conduit apertures, and wherein the second conduit proximal end comprises a plurality of second conduit apertures, wherein the leaflet attachment edge further comprises a leaflet aperture inner row including a plurality of leaflet apertures, wherein the leaflet attachment edge is disposed within the junction such that the leaflet aperture inner row is adjacent the conduit inner surface, wherein the suture passes through the leaflet apertures and extends along a conduit inner surface coupling the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end together.

2. The valved conduit of claim 1, wherein the first conduit distal end and the second conduit proximal have a complementary shape.

3. The valved conduit of claim 1, wherein in the first conduit distal end defines a plurality of parabolic valleys, and wherein the second conduit proximal defines a plurality of complementary conduit parabolic hills.

4. The valved conduit of claim 3, wherein the conduit parabolic hills further define commissure slots extending axially therefrom and therebetween, wherein a portion of the leaflet attachment edge that is adjacent to the free edge extends through the commissure slots.

5. The valved conduit of claim 4, wherein the valve structure is a leaflet construct comprising a plurality of separate leaflets, each leaflet including a commissure region that defines commissure tabs, wherein each of the commissure tabs are operable to be received within one of the commissure slots.

6. The valved conduit of claim 1, wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets.

7. The valved conduit of claim 1, wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend radially inward from the first conduit distal end, each of the leaflets defining an attachment region, a portion of the attachment region being between the first conduit distal end and the second conduit proximal end, each of the bridge regions extending through one of the commissure slots and defining a bridge loop that is adjacent to a conduit outer surface.

8. The valved conduit of claim 7, further comprising a retention element having a width that is larger than a width of the commissure slot, the bridge region defining a bride loop, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the commissure slot.

9. The valved conduit of claim 7, wherein an elastomer and/or elastomeric material is disposed within the bridge loop and cured making the bridge loop have a dimension larger than a dimension of the commissure slot so as to prevent the bridge loop from passing through the commissure slot.

10. The valved conduit of claim 1, wherein the leaflet attachment edge is coupled to a conduit outer surface at the junction.

11. The valved conduit of claim 1, wherein the second conduit further comprises a plurality of sinuses adjacent the second conduit proximal end, and wherein each leaflet is adjacent one of the sinuses.

12. The valved conduit of claim 11, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

13. The valved conduit of claim 12, wherein the junction including the sinuses are more dense and/or more rigid than a rest of the second conduit such that the sinuses retain their shape during handling and use.

14. The valved conduit of claim 1, further comprising a support frame coupled to a conduit outer surface at the junction, the support frame being a generally annular shape.

15. The valved conduit of claim 14, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

16. The valved conduit of claim 14, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

17. The valved conduit of claim 14, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

18. The valved conduit of claim 14, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

19. The valved conduit of claim 14, wherein the support frame is coupled to the conduit outer surface adjacent the junction by a suture that couples the first conduit distal end, the valve structure, and the second conduit proximal end.

20. The valved conduit of claim 1, wherein the leaflet comprises at least one fluoropolymer membrane layer.

21. The valved conduit of claim 1, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

22. The valved conduit of claim 21, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

23. The valved conduit of claim 22, wherein an elastomer and/or elastomeric material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both surfaces of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

24. The valved conduit of claim 23, wherein the elastomer and/or elastomeric material comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

25. The valved conduit of claim 23, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

26. The valved conduit 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 and/or elastomeric material present in the pores of at least one of the fluoropolymer membrane layers.

27. The valved conduit of claim 26, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

28. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material comprises (per)fluoroalkylvinylethers (PAVE).

29. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

30. The valved conduit of claim 26, wherein the fluoropolymer membrane layer comprises ePTFE.

31. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material is silicone.

32. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material is a fluoroelastomer.

33. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material is a urethane.

34. The valved conduit of claim 26, wherein the elastomer and/or elastomeric material is a TFE/PMVE copolymer.

35. The valved conduit of claim 34, 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.

36. A valved conduit comprising:

a conduit including a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, the conduit has a conduit inner surface and a conduit outer surface the first conduit distal end defining a plurality of commissure slots; and

a valve structure including at least one leaflet, each leaflet having a free edge and a leaflet attachment edge, the leaflet attachment edge disposed between the first conduit distal end and the second conduit proximal end that are coaxial therebetween defining a junction,

wherein the leaflet attachment edge is coupled between the first conduit distal end and the second conduit proximal end,

wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture,

wherein the first conduit distal end comprises a plurality of first conduit apertures, and wherein the second conduit proximal end comprises a plurality of second conduit apertures, wherein the leaflet attachment edge further comprises a leaflet aperture outer row including a plurality of leaflet apertures, wherein the leaflet attachment edge is disposed within the junction such that the leaflet aperture outer row is adjacent a conduit outer surface, wherein the suture passes through the leaflet apertures and extends along the conduit outer surface coupling the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end together.

37. The valved conduit of claim 36, wherein the first conduit distal end and the second conduit proximal have a complementary shape.

38. The valved conduit of claim 36, wherein in the first conduit distal end defines a plurality of parabolic valleys, and wherein the second conduit proximal defines a plurality of complementary conduit parabolic hills.

39. The valved conduit of claim 38, wherein the conduit parabolic hills further define commissure slots extending axially therefrom and therebetween, wherein a portion of the leaflet attachment edge that is adjacent to the free edge extends through the commissure slots.

40. The valved conduit of claim 39, wherein the valve structure is a leaflet construct comprising a plurality of separate leaflets, each leaflet including a commissure region that defines commissure tabs, wherein each of the commissure tabs are operable to be received within one of the commissure slots.

41. The valved conduit of claim 36, wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets.

42. The valved conduit of claim 36, wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend radially inward from the first conduit distal end, each of the leaflets defining an attachment region, a portion of the attachment region being between the first conduit distal end and the second conduit proximal end, each of the bridge regions extending through one of the commissure slots and defining a bridge loop that is adjacent to a conduit outer surface.

43. The valved conduit of claim 42, further comprising a retention element having a width that is larger than a width of the commissure slot, the bridge region defining a bride loop, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the commissure slot.

44. The valved conduit of claim 42, wherein an elastomer and/or elastomeric material is disposed within the bridge loop and cured making the bridge loop have a dimension larger than a dimension of the commissure slot so as to prevent the bridge loop from passing through the commissure slot.

45. The valved conduit of claim 36, wherein the leaflet attachment edge is coupled to a conduit outer surface at the junction.

46. The valved conduit of claim 36, wherein the second conduit further comprises a plurality of sinuses adjacent the second conduit proximal end, and wherein each leaflet is adjacent one of the sinuses.

47. The valved conduit of claim 46, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

48. The valved conduit of claim 47, wherein the junction including the sinuses are more dense and/or more rigid than a rest of the second conduit such that the sinuses retain their shape during handling and use.

49. The valved conduit of claim 36, further comprising a support frame coupled to a conduit outer surface at the junction, the support frame being a generally annular shape.

50. The valved conduit of claim 49, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

51. The valved conduit of claim 49, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

52. The valved conduit of claim 49, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

53. The valved conduit of claim 49, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

54. The valved conduit of claim 49, wherein the support frame is coupled to the conduit outer surface adjacent the junction by a suture that couples the first conduit distal end, the valve structure, and the second conduit proximal end.

55. The valved conduit of claim 36, wherein the leaflet comprises at least one fluoropolymer membrane layer.

56. The valved conduit of claim 36, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

57. The valved conduit of claim 56, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

58. The valved conduit of claim 57, wherein an elastomer and/or elastomeric material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both surfaces of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

59. The valved conduit of claim 58, wherein the elastomer and/or elastomeric material comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

60. The valved conduit of claim 58, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

61. The valved conduit of claim 36, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer and/or elastomeric material present in the pores of at least one of the fluoropolymer membrane layers.

62. The valved conduit of claim 61, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

63. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material comprises (per)fluoroalkylvinylethers (PAVE).

64. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

65. The valved conduit of claim 61, wherein the fluoropolymer membrane layer comprises ePTFE.

66. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material is silicone.

67. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material is a fluoroelastomer.

68. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material is a urethane.

69. The valved conduit of claim 61, wherein the elastomer and/or elastomeric material is a TFE/PMVE copolymer.

70. The valved conduit of claim 69, 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.

71. A valved conduit comprising:

a conduit including a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, the conduit has a conduit inner surface and a conduit outer surface the first conduit distal end defining a plurality of commissure slots; and

a valve structure including at least one leaflet, each leaflet having a free edge and a leaflet attachment edge, the leaflet attachment edge disposed between the first conduit distal end and the second conduit proximal end that are coaxial therebetween defining a junction,

wherein the leaflet attachment edge is coupled between the first conduit distal end and the second conduit proximal end,

wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture,

wherein the first conduit distal end comprises a plurality of first conduit apertures, and wherein the second conduit proximal end comprises a plurality of second conduit apertures, wherein the leaflet attachment edge further comprises a leaflet aperture inner row including a plurality of leaflet apertures and a leaflet aperture outer row including a plurality of leaflet apertures, wherein the leaflet attachment edge is disposed within the junction such that the leaflet aperture inner row is adjacent a conduit inner surface, and the leaflet aperture outer row is adjacent a conduit outer surface, wherein suture passes through the leaflet apertures and extends along the conduit inner surface and the conduit outer surface coupling the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end together.

72. The valved conduit of claim 71, wherein the first conduit distal end and the second conduit proximal have a complementary shape.

73. The valved conduit of claim 71, wherein in the first conduit distal end defines a plurality of parabolic valleys, and wherein the second conduit proximal defines a plurality of complementary conduit parabolic hills.

74. The valved conduit of claim 73, wherein the conduit parabolic hills further define commissure slots extending axially therefrom and therebetween, wherein a portion of the leaflet attachment edge that is adjacent to the free edge extends through the commissure slots.

75. The valved conduit of claim 74, wherein the valve structure is a leaflet construct comprising a plurality of separate leaflets, each leaflet including a commissure region that defines commissure tabs, wherein each of the commissure tabs are operable to be received within one of the commissure slots.

76. The valved conduit of claim 71, wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets.

77. The valved conduit of claim 71, wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend radially inward from the first conduit distal end, each of the leaflets defining an attachment region, a portion of the attachment region being between the first conduit distal end and the second conduit proximal end, each of the bridge regions extending through one of the commissure slots and defining a bridge loop that is adjacent to a conduit outer surface.

78. The valved conduit of claim 77, further comprising a retention element having a width that is larger than a width of the commissure slot, the bridge region defining a bride loop, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the commissure slot.

79. The valved conduit of claim 77, wherein an elastomer and/or elastomeric material is disposed within the bridge loop and cured making the bridge loop have a dimension larger than a dimension of the commissure slot so as to prevent the bridge loop from passing through the commissure slot.

80. The valved conduit of claim 71, wherein the leaflet attachment edge is coupled to a conduit outer surface at the junction.

81. The valved conduit of claim 71, wherein the second conduit further comprises a plurality of sinuses adjacent the second conduit proximal end, and wherein each leaflet is adjacent one of the sinuses.

82. The valved conduit of claim 81, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

83. The valved conduit of claim 82, wherein the junction including the sinuses are more dense and/or more rigid than a rest of the second conduit such that the sinuses retain their shape during handling and use.

84. The valved conduit of claim 71, further comprising a support frame coupled to a conduit outer surface at the junction, the support frame being a generally annular shape.

85. The valved conduit of claim 84, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

86. The valved conduit of claim 84, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

87. The valved conduit of claim 84, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

88. The valved conduit of claim 84, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

89. The valved conduit of claim 84, wherein the support frame is coupled to the conduit outer surface adjacent the junction by a suture that couples the first conduit distal end, the valve structure, and the second conduit proximal end.

90. The valved conduit of claim 71, wherein the leaflet comprises at least one fluoropolymer membrane layer.

91. The valved conduit of claim 71, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

92. The valved conduit of claim 91, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

93. The valved conduit of claim 92, wherein an elastomer and/or elastomeric material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both surfaces of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

94. The valved conduit of claim 93, wherein the elastomer and/or elastomeric material comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

95. The valved conduit of claim 93, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

96. The valved conduit of claim 71, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer and/or elastomeric material present in the pores of at least one of the fluoropolymer membrane layers.

97. The valved conduit of claim 96, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

98. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material comprises (per)fluoroalkylvinylethers (PAVE).

99. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

100. The valved conduit of claim 96, wherein the fluoropolymer membrane layer comprises ePTFE.

101. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material is silicone.

102. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material is a fluoroelastomer.

103. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material is a urethane.

104. The valved conduit of claim 96, wherein the elastomer and/or elastomeric material is a TFE/PMVE copolymer.

105. The valved conduit of claim 104, 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.

106. A valved conduit comprising:

a conduit including a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, the conduit has a conduit inner surface and a conduit outer surface the first conduit distal end defining a plurality of commissure slots; and

a valve structure including at least one leaflet, each leaflet having a free edge and a leaflet attachment edge, the leaflet attachment edge disposed between the first conduit distal end and the second conduit proximal end that are coaxial therebetween defining a junction,

wherein the leaflet attachment edge is coupled between the first conduit distal end and the second conduit proximal end,

wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture,

wherein the first conduit distal end comprises a plurality of first conduit apertures, and wherein the second conduit proximal end comprises a plurality of second conduit apertures, wherein the leaflet attachment edge further comprises a leaflet aperture inner row of a plurality of leaflet apertures collocated with a leaflet base and spaced apart from a leaflet aperture outer row of a plurality of leaflet apertures, a distance between the leaflet aperture inner row and the leaflet aperture outer row corresponds to a thickness of a conduit wall, where the leaflet attachment edge is located therebetween at the junction, the leaflet apertures of the leaflet aperture inner row are operable to allow passage of the suture therethrough adjacent a conduit inner surface, and the leaflet apertures of the leaflet aperture outer row are operable to allow passage of the suture therethrough adjacent a conduit outer surface, the leaflet apertures of the leaflet aperture inner row being in staggered relationship with the leaflet apertures of the leaflet aperture outer row so as to allow a zig-zag suture path.

107. The valved conduit of claim 106, wherein the first conduit distal end and the second conduit proximal have a complementary shape.

108. The valved conduit of claim 106, wherein in the first conduit distal end defines a plurality of parabolic valleys, and wherein the second conduit proximal defines a plurality of complementary conduit parabolic hills.

109. The valved conduit of claim 108, wherein the conduit parabolic hills further define commissure slots extending axially therefrom and therebetween, wherein a portion of the leaflet attachment edge that is adjacent to the free edge extends through the commissure slots.

110. The valved conduit of claim 109, wherein the valve structure is a leaflet construct comprising a plurality of separate leaflets, each leaflet including a commissure region that defines commissure tabs, wherein each of the commissure tabs are operable to be received within one of the commissure slots.

111. The valved conduit of claim 106, wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets.

112. The valved conduit of claim 106, wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend radially inward from the first conduit distal end, each of the leaflets defining an attachment region, a portion of the attachment region being between the first conduit distal end and the second conduit proximal end, each of the bridge regions extending through one of the commissure slots and defining a bridge loop that is adjacent to a conduit outer surface.

113. The valved conduit of claim 112, further comprising a retention element having a width that is larger than a width of the commissure slot, the bridge region defining a bride loop, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the commissure slot.

114. The valved conduit of claim 112, wherein an elastomer and/or elastomeric material is disposed within the bridge loop and cured making the bridge loop have a dimension larger than a dimension of the commissure slot so as to prevent the bridge loop from passing through the commissure slot.

115. The valved conduit of claim 106, wherein the leaflet attachment edge is coupled to a conduit outer surface at the junction.

116. The valved conduit of claim 106, wherein the second conduit further comprises a plurality of sinuses adjacent the second conduit proximal end, and wherein each leaflet is adjacent one of the sinuses.

117. The valved conduit of claim 116, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

118. The valved conduit of claim 117, wherein the junction including the sinuses are more dense and/or more rigid than a rest of the second conduit such that the sinuses retain their shape during handling and use.

119. The valved conduit of claim 106, further comprising a support frame coupled to a conduit outer surface at the junction, the support frame being a generally annular shape.

120. The valved conduit of claim 119, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

121. The valved conduit of claim 119, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

122. The valved conduit of claim 119, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

123. The valved conduit of claim 119, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

124. The valved conduit of claim 119, wherein the support frame is coupled to the conduit outer surface adjacent the junction by a suture that couples the first conduit distal end, the valve structure, and the second conduit proximal end.

125. The valved conduit of claim 106, wherein the leaflet comprises at least one fluoropolymer membrane layer.

126. The valved conduit of claim 106, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

127. The valved conduit of claim 126, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

128. The valved conduit of claim 127, wherein an elastomer and/or elastomeric material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both surfaces of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

129. The valved conduit of claim 128, wherein the elastomer and/or elastomeric material comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

130. The valved conduit of claim 128, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

131. The valved conduit of claim 106, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer and/or elastomeric material present in the pores of at least one of the fluoropolymer membrane layers.

132. The valved conduit of claim 131, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

133. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material comprises (per)fluoroalkylvinylethers (PAVE).

134. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

135. The valved conduit of claim 131, wherein the fluoropolymer membrane layer comprises ePTFE.

136. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material is silicone.

137. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material is a fluoroelastomer.

138. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material is a urethane.

139. The valved conduit of claim 131, wherein the elastomer and/or elastomeric material is a TFE/PMVE copolymer.

140. The valved conduit of claim 139, 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.

141. A valved conduit comprising:

a conduit including a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, the conduit has a conduit inner surface and a conduit outer surface the first conduit distal end defining a plurality of commissure slots; and

a valve structure including at least one leaflet, each leaflet having a free edge and a leaflet attachment edge, the leaflet attachment edge disposed between the first conduit distal end and the second conduit proximal end that are coaxial therebetween defining a junction,

wherein the leaflet attachment edge is coupled between the first conduit distal end and the second conduit proximal end,

wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture,

wherein the first conduit distal end comprises a plurality of first conduit apertures, and wherein the second conduit proximal end comprises a plurality of second conduit apertures, wherein the leaflet attachment edge further comprises a leaflet aperture inner row of a plurality of leaflet apertures collocated with a leaflet base and spaced apart from a leaflet aperture outer row of a plurality of leaflet apertures, wherein the leaflet attachment edge is disposed between the first conduit distal end and the second conduit proximal end with a conduit wall positioned between the leaflet aperture inner row and the leaflet aperture outer row of the leaflet apertures, wherein the suture is passed from a first conduit outer surface through one of the first conduit apertures to the conduit inner surface, extending along a conduit inner surface then passed through an adjacent leaflet aperture of the leaflet aperture inner row, and extending along the conduit inner surface then passed through an adjacent second conduit aperture to the conduit outer surface, extending along the conduit outer surface, then passed through an adjacent leaflet aperture of the leaflet aperture outer row, and along the conduit outer surface to a next adjacent first conduit aperture and so forth progressing along respective rows of apertures, and thus coupling the first conduit distal end and the second conduit proximal end together with the leaflet attachment edge therebetween.

142. The valved conduit of claim 141, wherein the first conduit distal end and the second conduit proximal have a complementary shape.

143. The valved conduit of claim 141, wherein in the first conduit distal end defines a plurality of parabolic valleys, and wherein the second conduit proximal defines a plurality of complementary conduit parabolic hills.

144. The valved conduit of claim 143, wherein the conduit parabolic hills further define commissure slots extending axially therefrom and therebetween, wherein a portion of the leaflet attachment edge that is adjacent to the free edge extends through the commissure slots.

145. The valved conduit of claim 144, wherein the valve structure is a leaflet construct comprising a plurality of separate leaflets, each leaflet including a commissure region that defines commissure tabs, wherein each of the commissure tabs are operable to be received within one of the commissure slots.

146. The valved conduit of claim 141, wherein the valve structure is a leaflet construct comprising a plurality of leaflets that are joined together by a bridge region between adjacent leaflets.

147. The valved conduit of claim 141, wherein the valve structure comprises a leaflet construct defining a contiguous annular ring comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend radially inward from the first conduit distal end, each of the leaflets defining an attachment region, a portion of the attachment region being between the first conduit distal end and the second conduit proximal end, each of the bridge regions extending through one of the commissure slots and defining a bridge loop that is adjacent to a conduit outer surface.

148. The valved conduit of claim 147, further comprising a retention element having a width that is larger than a width of the commissure slot, the bridge region defining a bride loop, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the commissure slot.

149. The valved conduit of claim 147, wherein an elastomer and/or elastomeric material is disposed within the bridge loop and cured making the bridge loop have a dimension larger than a dimension of the commissure slot so as to prevent the bridge loop from passing through the commissure slot.

150. The valved conduit of claim 141, wherein the leaflet attachment edge is coupled to a conduit outer surface at the junction.

151. The valved conduit of claim 141, wherein the second conduit further comprises a plurality of sinuses adjacent the second conduit proximal end, and wherein each leaflet is adjacent one of the sinuses.

152. The valved conduit of claim 151, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

153. The valved conduit of claim 152, wherein the junction including the sinuses are more dense and/or more rigid than a rest of the second conduit such that the sinuses retain their shape during handling and use.

154. The valved conduit of claim 141, further comprising a support frame coupled to a conduit outer surface at the junction, the support frame being a generally annular shape.

155. The valved conduit of claim 154, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

156. The valved conduit of claim 154, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

157. The valved conduit of claim 154, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

158. The valved conduit of claim 154, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

159. The valved conduit of claim 154, wherein the support frame is coupled to the conduit outer surface adjacent the junction by a suture that couples the first conduit distal end, the valve structure, and the second conduit proximal end.

160. The valved conduit of claim 141, wherein the leaflet comprises at least one fluoropolymer membrane layer.

161. The valved conduit of claim 141, wherein the leaflet comprises a laminate having more than one fluoropolymer membrane layer.

162. The valved conduit of claim 161, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

163. The valved conduit of claim 162, wherein an elastomer and/or elastomeric material is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both surfaces of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

164. The valved conduit of claim 163, wherein the elastomer and/or elastomeric material comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

165. The valved conduit of claim 164, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

166. The valved conduit of claim 141, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer and/or elastomeric material present in the pores of at least one of the fluoropolymer membrane layers.

167. The valved conduit of claim 166, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

168. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material comprises (per)fluoroalkylvinylethers (PAVE).

169. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

170. The valved conduit of claim 166, wherein the fluoropolymer membrane layer comprises ePTFE.

171. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material is silicone.

172. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material is a fluoroelastomer.

173. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material is a urethane.

174. The valved conduit of claim 166, wherein the elastomer and/or elastomeric material is a TFE/PMVE copolymer.

175. The valved conduit of claim 174, 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.