VALVED CONDUIT

• US 20160100939A1
• Filed: 10/12/2015
• Published: 04/14/2016
• 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.
• Granted Patent: US 10,507,101 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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.

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 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 at least a portion of the leaflets extend at an angle greater than 45 degrees from the conduit inner surface in a downstream direction at the junction, whereby the leaflets exhibit a bias toward a closed position.

11. The valved conduit of claim 1, wherein the leaflets extend perpendicular from the conduit inner surface at the junction, whereby the leaflets exhibit a bias toward a closed position.

12. The valved conduit of claim 1, wherein the leaflets extend at an angle to the conduit inner surface in a downstream direction at the junction that is between the angle of the leaflets in an open position and a closed position.

13. The valved conduit of claim 1, wherein the first conduit distal end, the leaflet attachment edge, and the second conduit proximal end are coupled together with suture.

14. The valved conduit of claim 13, 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.

15. The valved conduit of claim 13, 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.

16. The valved conduit of claim 13, 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.

17. The valved conduit of claim 13, 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.

18. The valved conduit of claim 13, 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.

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

20. The valved conduit of claim 1, wherein the leaflet attachment edge of each of the leaflets extends between the first conduit distal end and the second conduit proximal end and coupled thereto with means selected from a list consisting of suture, adhesive, and thermal bonding.

21. 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.

22. The valved conduit of claim 21, wherein the sinuses are generally concave with respect to a conduit inner surface of the conduit.

23. The valved conduit of claim 22, 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.

24. 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.

25. The valved conduit of claim 24, wherein the support frame defines a complementary shape of the first conduit distal end, and also defines a complementary shape of a leaflet base.

26. The valved conduit of claim 24, wherein the support frame is operable to retain a circular shape of the conduit inner surface at the junction.

27. The valved conduit of claim 24, wherein the support frame is made of a radiopaque material and operable to be seen under x-ray visualization techniques.

28. The valved conduit of claim 24, wherein the support frame lies on top of or just adjacent to the junction on the conduit outer surface.

29. The valved conduit of claim 24, 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.

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

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

32. The valved conduit of claim 31, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

33. The valved conduit of claim 32, wherein an elastomer 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.

34. The valved conduit of claim 33, wherein the elastomer comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

35. The valved conduit of claim 33, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

36. 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 present in the pores of at least one of the fluoropolymer membrane layers.

37. The valved conduit of claim 36, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

38. The valved conduit of claim 36, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

39. The valved conduit of claim 36, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

40. The valved conduit of claim 36, wherein the fluoropolymer membrane layer comprises ePTFE.

41. The valved conduit of claim 36, wherein the elastomer is silicone.

42. The valved conduit of claim 36, wherein the elastomer is a fluoroelastomer.

43. The valved conduit of claim 36, wherein the elastomer is a urethane.

44. The valved conduit of claim 36, wherein the elastomer is a TFE/PMVE copolymer.

45. The valved conduit of claim 44, 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.

65. The valved conduit of claim 1, wherein the first conduit distal end defines a first conduit joint surface and the second conduit proximal end defines a second conduit joint surface at the junction that is complementary with the first conduit joint surface, the first conduit joint surface and the second conduit joint surface are substantially planar and adapted to interface closely together to produce a tight seam when coupled together, the first conduit joint surface and the second conduit joint surface are at an angle greater than 45 degree to the conduit inner surface in a downstream direction such that at least a portion of the leaflets extend at an angle greater than 45 degrees from the conduit inner surface in the downstream direction at the junction, whereby the leaflets exhibit a bias toward a closed position.

66. The valved conduit of claim 1, wherein the first conduit distal end defines a first conduit joint surface and the second conduit proximal end defines a second conduit joint surface at the junction that is complementary with the first conduit joint surface, the first conduit joint surface and the second conduit joint surface are substantially planar and adapted to interface closely together to produce a tight seam when coupled together, the first conduit joint surface and the second conduit joint surface are perpendicular to the conduit inner surface wherein the leaflets extend perpendicular from the conduit inner surface at the junction, whereby the leaflets exhibit a bias toward a closed position.

67. The valved conduit of claim 1, wherein the first conduit distal end defines a first conduit joint surface and the second conduit proximal end defines a second conduit joint surface at the junction that is complementary with the first conduit joint surface, the first conduit joint surface and the second conduit joint surface are substantially planar and adapted to interface closely together to produce a tight seam when coupled together, the first conduit joint surface and the second conduit joint surface are at an angle to the conduit inner surface in a downstream direction at the junction that is at or between an angle of the leaflets in an open position and a closed position wherein the leaflets extend at an angle to the conduit inner surface in the downstream direction at the junction that is at or between the angle of the leaflets in the open position and the closed positions.

46. A valved conduit comprising:

a leaflet; and

a conduit, wherein the leaflet includes a portion that is external to the conduit and a portion that is internal to the conduit.

47. The valved conduit of claim 46, wherein the leaflet extends perpendicular from a conduit inner surface such that the leaflet is biased towards a closed position.

48. The valved conduit of claim 46, wherein the leaflet extends from a conduit inner surface at an angle of greater than 45 degrees such that the leaflet is biased towards a closed position.

49. The valved conduit of claim 46, wherein the conduit includes sinuses that are distal from the leaflets.

50. 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 defining commissure slots, the conduit having a conduit inner surface and a conduit outer surface; and

a leaflet construct defining one or more leaflets and a bridge region,

wherein each of the bridge regions pass through one of the commissure slots, and wherein the leaflets extend from the conduit inner surface.

51. The valved conduit of claim 50, wherein the leaflet construct is a contiguous annular ring defining a plurality of leaflets and a bridge region between each of the leaflets, each bridge region defining a bridge loop and a coaptation neck, and

wherein each of the coaptation necks passes through one of the commissure slots with the bridge loop being adjacent the conduit outer surface and wherein the leaflets extend from the conduit inner surface.

52. The valved conduit of claim 51, further comprising a plurality of retention elements, each retention element being operable to be received within the bridge loop, each retention element having a dimension larger than a width of the commissure slot, wherein one of the retention elements is received within each bridge loop with the bridge loop being adjacent to the conduit outer surface.

53. The valved conduit of claim 50, wherein the leaflets extend from the commissure slot in a direction perpendicular to the conduit inner surface.

54. The valved conduit of claim 50, wherein the leaflet construct is mechanically coupled to the conduit at the conduit outer surface.

55. A method of making a valved conduit, comprising:

obtaining a conduit;

cutting the conduit into a first conduit and a second conduit along a cut line defining a first conduit distal end and a second conduit proximal end;

defining a plurality of commissure slots in the second conduit proximal end;

obtaining a material comprising one or more layers of expanded PTFE composite;

cutting a leaflet construct including a plurality of leaflets each being separated by a bridge region from the material, the leaflets defining an leaflet attachment edge;

folding each of the bridge regions defining a bridge loop and a coaptation neck, the coaptation neck extending radially from a conduit inner surface;

disposing respective coaptation necks into each of the commissure slots; and

suturing the first conduit distal end and the second conduit proximal end with the leaflet attachment edge therebetween defining a junction.

56. The method of claim 55, further comprising:

providing a support frame; and

coupling the support frame about the junction adjacent a conduit outer surface.

57. The method of claim 55, further comprising:

obtaining a plurality of retention elements; and

disposing a retention element into each of the bridge loops adjacent an outer surface of the conduit.

58. The method of claim 55, further comprising sealing the parting line and apertures in the conduit.

59. A method of making a valved conduit, comprising:

providing a leaflet construct defining a plurality of leaflets each having a free edge and a leaflet attachment edge adjacent a leaflet base, adjacent leaflets being coupled together by a bridge region;

providing a conduit;

cutting the conduit along a parting line into a first conduit having a first conduit distal end and a second conduit having a second conduit proximal end, wherein the parting line proscribes a predetermined pattern suitable for a leaflet base, the conduit having a conduit inner surface and a conduit outer surface;

forming a plurality of commissure slots at second conduit proximal end;

forming a commissure region in the leaflet attachment edge adjacent the free edge, and

disposing the commissure region of the leaflet attachment edge into the commissure slots in the second conduit proximal end; and

coupling the first conduit distal end and the second conduit proximal end adjacent therewith with the leaflet attachment edge of the leaflet therebetween defining a junction.

60. The method of claim 59, further comprising:

providing a support frame having a shape substantially that of the parting line; and

coupling the support frame to an outer surface at a junction.

61. The method of claim 60, further comprising:

forming a plurality of apertures adjacent the first conduit distal end and the second conduit proximal end;

forming a leaflet aperture inner row and a leaflet aperture outer row of leaflet apertures adjacent the leaflet attachment edge;

suturing along the parting line of the conduit by advancing suture in one of the apertures in the first conduit distal end to the conduit inner surface, passing through a leaflet aperture of a leaflet aperture inner row, passing out through one of the apertures in the second conduit proximal end to the conduit outer surface, over an outer diameter of the support frame, and then through a leaflet aperture of a leaflet aperture outer row;

repeating the suturing with a next set of apertures along the parting line; and

tension the suture to adjoin the parting line of the first conduit distal end and the second conduit proximal end with the leaflet attachment edge disposed in the junction.

62. The method of claim 59, further comprising:

forming a loop in the bridge region of the leaflet construct; and

disposing a retention element within the loop after disposing the bridge region into the commissure slot.

63. The method of claim 59, further comprising:

forming a plurality of apertures adjacent the first conduit distal end and the second conduit proximal end;

forming a leaflet aperture inner row and a leaflet aperture outer row of leaflet apertures adjacent the leaflet attachment edge;

suturing along the parting line of the conduit by advancing suture in one of the apertures in the first conduit distal end to the conduit inner surface, passing through a leaflet aperture of a leaflet aperture inner row, passing out through one of the apertures in the second conduit proximal end to the conduit outer surface, and then through a leaflet aperture of a leaflet aperture outer row;

repeating the suturing with a next set of apertures along the parting line; and

tension the suture to adjoin the parting line of the first conduit distal end and the second conduit proximal end with the leaflet attachment edge disposed in the junction.

64. The method of claim 59, further comprising sealing the parting line and apertures in the conduit.