PROSTHETIC VALVED CONDUITS WITH MECHANICALLY COUPLED LEAFLETS

• US 20160175095A1
• 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 9,937,037 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 non-sewn 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 valved conduit 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 leaflet frame first edge, a leaflet frame second edge opposite the leaflet frame first edge,

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;

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

a restraining element configured to provide a mechanical interference to impede decoupling of a respective leaflet from a respective leaflet frame projection;

a first frame defining an annular shape having a first frame first edge and a first frame second edge opposite the first frame first edge, wherein the first frame first edge is substantially complementary to the leaflet frame second edge; and

a first conduit defining a tubular shape having a first conduit first luminal end, a first conduit second luminal end, and a first conduit lumen therethrough, wherein the first conduit has a first conduit mating surface at the first conduit second luminal end that defines a plurality of first conduit 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,

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,

wherein the first conduit mating surface is disposed between the leaflet frame second edge and the leaflet attachment region, and

wherein the leaflet frame is fixedly coupled to the first frame such that the first conduit mating surface and the leaflet attachment region are retained therebetween.

2. The prosthetic valved conduit of claim 1, wherein the first frame and the leaflet frame are substantially coaxial.

3. The prosthetic valved conduit of claim 1, wherein the leaflet frame second edge defines a plurality of concavities and the first frame first edge defines a plurality of corresponding convexities.

4. The prosthetic valved conduit of claim 3, wherein each of the plurality of leaflets disposed within a corresponding one of the plurality of concavities.

5. The prosthetic valved conduit of claim 1, further comprising a second conduit defining a tubular shape having a second conduit first luminal end, a second conduit second luminal end, and a second conduit lumen therethrough, wherein the second conduit defines a second conduit mating surface at the second conduit first luminal end that is disposed between the first frame first edge and the leaflet attachment region and wherein the leaflet frame is fixedly coupled to the first frame whereby retaining the first conduit mating surface, the leaflet attachment region, and the second conduit mating surface therebetween.

6. The prosthetic valved conduit of claim 5, wherein at least some of the plurality of leaflet frame projections has a projection tip that is embedded in the second conduit mating surface.

7. The prosthetic valved conduit of claim 5, wherein the leaflet frame circumscribes the first conduit and wherein the first frame circumscribes the second conduit and is coupled to a second conduit outer surface.

8. The prosthetic valved conduit of claim 5, wherein a first frame inner surface is substantially aligned with a leaflet frame inner surface.

9. The prosthetic valved conduit of claim 1, further comprising one or more bridge members being coupled to and extending between the leaflet frame and the first frame such that the leaflet attachment region of each leaflet is retained between the leaflet frame and the first frame.

10. The prosthetic valved conduit of claim 9, further comprising a second frame defining an annular shape and having a second frame first edge and a second frame second edge opposite the second frame first edge, wherein the second frame second edge is substantially complementary to the leaflet frame first edge, wherein the one or more bridge members extend between the second frame first edge and the first frame second edge and is coupled thereto, such that the second frame and the first frame retain the leaflet frame and the leaflet attachment region of each leaflet therebetween.

11. The prosthetic valved conduit of claim 9, wherein the one or more bridge members comprises a valve collar defining a cylinder and circumscribing the leaflet frame.

12. The prosthetic valved conduit of claim 11, further comprising a retaining member defining an annular shape, wherein a second frame outer surface of the second frame defines a channel and the retaining member is disposed in the channel circumscribing the valve collar, whereby restricting movement of the valve collar.

13. The prosthetic valved conduit of claim 12, wherein the valve collar comprises an inelastic film.

14. The prosthetic valved conduit of claim 13, wherein the second frame circumscribes the valve collar and the valve collar is everted about the second frame.

15. The prosthetic valved conduit of claim 11, wherein the valve collar circumscribes the first frame and fixedly coupled to a second conduit outer surface of the second conduit adjacent to the first frame second edge.

16. The prosthetic valved conduit of claim 1, wherein the plurality of leaflet frame projections are disposed between the leaflet frame second edge and the first frame first edge.

17. The prosthetic valved conduit of claim 5, wherein each of the first conduit and the second conduit are a prosthetic vascular graft.

18. The prosthetic valved conduit of claim 5, wherein each of the first conduit and the second conduit comprises an expanded fluoropolymer.

19. The prosthetic valved conduit of claim 18, wherein each of the first conduit and the second conduit comprises an extruded tube of expanded polytetrafluoroethylene.

20. A prosthetic valved conduit comprising

a first conduit;

a second conduit;

a leaflet frame defining an annular shape having a leaflet frame first edge and a leaflet frame second edge opposite the leaflet frame first edge;

a first frame defining an annular shape having a first frame first edge and a first frame second edge opposite the first frame first edge, wherein the first frame first edge is substantially complementary to the leaflet frame second edge;

a plurality of leaflets, each leaflet having a leaflet attachment region and a leaflet free edge, wherein the leaflet attachment region of each leaflet is disposed between the leaflet frame second edge and the first frame first edge, the leaflet attachment region disposed at a junction between the first conduit and the second conduit;

the first conduit defining a tubular shape having a first conduit first luminal end, a first conduit second luminal end, and a lumen therethrough, wherein the first conduit defines a first conduit mating surface at the first conduit second luminal end that is disposed between the leaflet frame second edge and the leaflet attachment region; and

the second conduit defining a tubular shape having a second conduit first luminal end, a second conduit second luminal end, and a lumen therethrough, wherein the second conduit defines a second conduit mating surface at the second conduit first luminal end that is disposed between the first frame first edge and the leaflet attachment region,

wherein the leaflet frame is fixedly coupled to the first frame whereby retaining the leaflet attachment region between the first conduit mating surface and the second conduit mating surface.

21. The prosthetic valved conduit of claim 20, wherein the leaflet frame second edge defines a plurality of concavities and the first frame first edge defines a plurality of corresponding convexities.

22. The prosthetic valved conduit of claim 21, wherein each of the plurality of leaflets disposed within a corresponding one of the plurality of concavities.

23. The prosthetic valved conduit of claim 20, wherein the leaflet frame circumscribes the first conduit and wherein the first frame circumscribes the second conduit and is coupled to a second conduit outer surface.

24. The prosthetic valved conduit of claim 20, wherein the first frame and the leaflet frame are substantially coaxial.

25. The prosthetic valved conduit of claim 20, wherein a first frame inner surface is substantially aligned with a leaflet frame inner surface.

26. The prosthetic valved conduit of claim 20, further comprising one or more bridge members being coupled to and extending between the leaflet frame and the first frame such that the leaflet attachment region of each leaflet is retained between the leaflet frame and the first frame.

27. The prosthetic valved conduit of claim 26, further comprising a second frame defining an annular shape having a second frame first edge and a second frame second edge opposite the second frame first edge, wherein the second frame second edge is substantially complementary to the leaflet frame first edge, wherein the one or more bridge members extend between the second frame first edge and the first frame second edge and is coupled thereto, such that the second frame and the first frame retain the leaflet frame and the leaflet attachment region of each leaflet therebetween.

28. The prosthetic valved conduit of claim 27, wherein the one or more bridge members comprises a valve collar defining a cylinder and circumscribing the leaflet frame.

29. The prosthetic valved conduit of claim 28, further comprising a retaining member defining an annular shape, wherein a second frame outer surface of the second frame defines a channel, the retaining member being disposed in the channel circumscribing the valve collar, whereby restricting movement of the valve collar.

30. The prosthetic valved conduit of claim 29, wherein the valve collar comprises an inelastic film.

31. The prosthetic valved conduit of claim 30, wherein the second frame circumscribes the valve collar and the valve collar is everted about the second frame.

32. The prosthetic valved conduit of claim 28, wherein the valve collar circumscribes the first frame and is fixedly coupled to a second conduit outer surface of the second conduit adjacent to the first frame second edge.

33. The prosthetic valved conduit of claim 20, wherein the leaflet frame has a plurality of leaflet frame projections extending from the leaflet frame second edge.

34. The prosthetic valved conduit of claim 33, wherein each leaflet attachment region defines a plurality of leaflet apertures, each of the plurality of leaflet frame projections extending through a corresponding one of the plurality of leaflet apertures.

35. The prosthetic valved conduit of claim 34, wherein each leaflet attachment region defines a plurality of leaflet apertures, each of the plurality of leaflet frame projections extending through a corresponding one of the plurality of leaflet apertures and wherein the first conduit second end defines a plurality of first conduit apertures, each of the plurality of leaflet frame projections extending through a corresponding one of the plurality of first conduit apertures.

36. The prosthetic valved conduit of claim 33, wherein each leaflet frame projection has a projection tip and the projection tip is embedded in the second conduit mating surface.

37. The prosthetic valved conduit of claim 21, wherein the leaflet frame has a plurality of commissure posts and a set of leaflet frame elements flanking each side of each commissure post, each set of leaflet frame elements defining a corresponding one of the plurality of concavities.

38. The prosthetic valved conduit of claim 37, wherein the set of leaflet frame elements include a leaflet frame base flanked on each side by a leaflet frame side that together define three sides of an isosceles trapezoid, wherein the leaflet frame base defines a leaflet frame base second edge that is substantially flat.

39. The prosthetic valved conduit of claim 20, wherein each leaflet is extendible in a direction that is substantially perpendicular from a leaflet frame inner surface such that each leaflet is biased towards a closed position.

40. The prosthetic valved conduit of claim 20, wherein each of the first conduit and the second conduit are a prosthetic vascular graft.

41. The prosthetic valved conduit of claim 20, wherein each of the first conduit and the second conduit comprises an expanded fluoropolymer.

42. The prosthetic valved conduit of claim 41, wherein each of the first conduit and the second conduit comprises an extruded tube of expanded polytetrafluoroethylene.

43. A prosthetic valved conduit comprising:

a first conduit;

a second conduit; and

a prosthetic valve comprising

a leaflet frame defining an annular shape having a leaflet frame first edge and a leaflet frame second edge opposite the leaflet frame first edge, and

a plurality of leaflets, each leaflet having a leaflet attachment region and a leaflet free edge, wherein the leaflet attachment region of each leaflet coupled to the leaflet frame second edge, the leaflet attachment region disposed at a junction between the first conduit and the second conduit, each leaflet having a leaflet inflow side and a leaflet outflow side opposite the leaflet inflow side,

the first conduit extending between a first conduit first end and a first conduit second end and defining a first conduit lumen on the leaflet inflow side of the leaflets, wherein the leaflet frame circumscribes a section of the first conduit and is coupled to the first conduit second end, and

the second conduit extending between a second conduit first end and a second conduit second end and defining a second conduit inner surface, with a second conduit first portion nearer the second conduit second end defining a lumen on the leaflet outflow side of the leaflets and a second conduit second portion nearer the second conduit first end defining a circumferential recess on the second conduit inner surface, the circumferential recess having a shape that substantially complements the shape of the leaflet frame,

wherein the leaflet frame is disposed within the circumferential recess, and

wherein the first conduit is coupled to the second conduit.

44. The prosthetic valved conduit of claim 43, further comprising a first frame defining an annular shape having a first frame first edge and a first frame second edge opposite the first frame first edge, wherein the first frame first edge is substantially complementary to the leaflet frame second edge, wherein the first frame circumscribes and is coupled to the first conduit.

45. The prosthetic valved conduit of claim 44, further comprising a second frame defining an annular shape having a second frame first edge and a second frame second edge opposite the second frame first edge, wherein the second frame second edge is substantially complementary to the leaflet frame first edge and the second frame and the first frame are configured to retain the leaflet frame and the leaflet attachment region such that the leaflets are retained.