Prosthetic valves with mechanically coupled leaflets

• US 10,653,521 B2
• Filed: 12/01/2017
• Issued: 05/19/2020
• 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.
• Primary Examiner(s): Gherbi, Suzette J
• Application Number:
  US15/829,595
• Publication Number:
  US 20180110619A1
• Time in Patent Office: 900 Days
• Field of Search: 623 21- 219
• 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 plurality of leaflets, each leaflet having a leaflet attachment region and a leaflet free edge;

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, 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, wherein the restraining element is integral to each of the leaflet frame projections, wherein the restraining element includes a projection head portion.

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

8. 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 a 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.

9. The prosthetic valve of claim 8, wherein a leaflet retention surface is the leaflet frame second edge.

10. The prosthetic valve of claim 8, 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.

11. The prosthetic valve of claim 10, 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.

12. The prosthetic valve of claim 11, wherein the set of leaflet window frame elements includes two leaflet window sides and a leaflet window base therebetween.

13. The prosthetic valve of claim 12, wherein the leaflet window sides each define a side receiving slot therethrough and the leaflet window base defines a base receiving slot therethrough, wherein the leaflet window sides include a portion of the leaflet retention surface and wherein the leaflet window base includes a portion of the leaflet retention surface, and

wherein 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.

14. The prosthetic valve of claim 13, wherein the leaflet attachment region defines one or more notches.

15. The prosthetic valve of claim 13, wherein the leaflet retention surface is the leaflet frame second edge.

16. The prosthetic valve of claim 13, wherein the one or more of the leaflet window frame elements defines a leaflet frame opening therethrough that is adjacent to a 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.

17. The prosthetic valve of claim 13, wherein the set of leaflet window frame elements together defines three sides of an isosceles trapezoid, wherein the leaflet window base defines a leaflet window base second edge that is substantially straight.

18. The prosthetic valve of claim 8, wherein the leaflet frame projections extend in a direction that is substantially normal to the leaflet retention surface.

19. The prosthetic valve of claim 8, 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.

20. The prosthetic valve of claim 19, wherein the locking bar is coupled with the at least one leaflet frame projection.

21. The prosthetic valve of claim 19, 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.

22. The prosthetic valve of claim 21, 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.

23. The prosthetic valve of claim 19, 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.

24. The prosthetic valve of claim 8, 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.

25. The prosthetic valve of claim 24, 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.

26. The prosthetic valve of claim 25, 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 attachable locking bar to the locking clip by capturing the locking clip between the bar-shaped element and the retention hook.

27. The prosthetic valve of claim 24, 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.

32. 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.

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

36. 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.

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

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

3. A prosthetic valve comprising:

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

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, 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, 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.

4. A prosthetic valve comprising:

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

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, 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, 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.

5. A prosthetic valve comprising:

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

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, wherein a distance between adjacent leaflet frame projections is less than 2 mm.

6. A prosthetic valve comprising:

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

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, wherein a distance between adjacent leaflet frame projections is at least 0.5 mm.

28. A prosthetic valve comprising:

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

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, wherein the leaflet is formed of a leaflet material that is reinforced at the leaflet attachment region.

29. A prosthetic valve comprising:

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

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

30. The prosthetic valve of claim 29, 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.

31. The prosthetic valve of claim 30, wherein the lip defines one or more recesses into which the leaflet frame projections extend and received therein.

33. A prosthetic valve comprising:

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

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, 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.

34. A prosthetic valve comprising:

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

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, 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.

37. A prosthetic valve comprising:

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

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

38. The prosthetic valve of claim 37, 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.