Prosthetic heart valve with retention elements

• US 9,827,094 B2
• Filed: 09/14/2015
• Issued: 11/28/2017
• Est. Priority Date: 09/15/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bennett, Nathan L.
• Primary Examiner(s): Stewart, Jason-Dennis
• Application Number:
  US14/853,654
• Publication Number:
  US 20160074161A1
• Time in Patent Office: 806 Days
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct. The leaflet construct is at least partially coupled to a leaflet frame outer side of the leaflet frame and being coupled thereto by a retention element.

Claims

1. A prosthetic valve, comprising:

a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side, the leaflet frame having a leaflet frame central axis and a plurality of commissure posts extending parallel to the leaflet frame central axis that are spaced from one another, each commissure post defining a post slot therethrough that is aligned parallel to the leaflet frame central axis, between the commissure posts and contiguous therewith is a leaflet window;

a leaflet construct defining a seamless cylinder comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend inward from the leaflet frame, each of the leaflets defining a fold-over portion that is folded over and lies against the leaflet frame outer side of the leaflet frame and coupled thereto, each of the bridge regions extending through one of the post slots and defining a bridge loop that is adjacent to the leaflet frame outer side; and

a retention element having a width that is larger than a width of the post slot, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the post slot.

2. The prosthetic valve of claim 1 wherein the fold-over portion of each of the leaflets is folded around an inflow edge of the leaflet frame and coupled to the leaflet frame outer side.

3. The prosthetic valve of claim 1 wherein each commissure post comprises a first post leg and a second post leg that extend from the leaflet window toward a commissure tip that is associated with the respective commissure post, the first post leg and the second post leg of each commissure post being spaced from one another defining the post slot.

4. The prosthetic valve of claim 3 wherein spacing between the first post leg and the second post leg defining a post slot that is dimensioned such that the bridge region of the leaflet construct may pass through.

5. The prosthetic valve of claim 3 wherein the leaflet window is defined by elements defining three sides of an isosceles trapezoid having two leaflet window sides diverging from a leaflet base, wherein the leaflet base is perpendicular to the leaflet frame central axis.

6. The prosthetic valve of claim 1 wherein the leaflet frame includes a plurality of frame apertures and wherein the commissure posts include a plurality of post apertures that pass through the leaflet frame from the leaflet frame inner side to the leaflet frame outer side and that are spaced from one another, and wherein each retention element includes a plurality of retention element apertures each of which is aligned with a respective one of the post apertures in a respective commissure post.

7. The prosthetic valve defined in claim 6 further comprising securement structure that passes through respective aligned post apertures and retention element apertures operable to couple the retention element to the commissure post.

8. The prosthetic valve of claim 7 wherein each bridge region includes a plurality of bridge apertures, each of which are aligned with a respective one of the post apertures and respective retention element apertures.

9. The prosthetic valve of claim 8 wherein each of the fold-over portions of the leaflets includes a plurality of fold-over apertures, each of which is aligned with a respective one of the frame apertures in the leaflet window, the securement structure passing through aligned frame apertures and respective fold-over apertures operable to couple the fold-over portion to the leaflet windows.

10. The prosthetic valve of claim 9 wherein the securement structure comprises suture.

11. The prosthetic valve of claim 9, further comprising a base frame defining a cylinder having a base frame central axis and having a diameter that is the same as a diameter of the leaflet frame, the base frame defining a plurality of triangular regions extending away from an inflow edge, the base frame having a base frame inner side and a base frame outer side,

wherein two sides of adjacent leaflet windows of the leaflet frame define two sides of an isosceles triangle on the inflow edge of the leaflet frame, the base frame being in coaxial alignment with the leaflet frame, each of the triangular regions of the base frame being operable to be received within the two sides of adjacent leaflet windows of the leaflet frame defining the two sides of an isosceles triangle.

12. The prosthetic valve of claim 11 wherein the base frame includes a plurality of base frame apertures that pass through the base frame from the base frame inner side to the base frame outer side, and wherein the leaflet frame and the base frame are coupled together by a second securement structure that passes through adjacent base frame apertures and fold-over apertures of the leaflet frame operable to couple the base frame to the leaflet window of the leaflet frame.

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

14. The prosthetic valve of claim 13, wherein the at least one fluoropolymer membrane layer is an expanded fluoropolymer membrane layer.

15. The prosthetic valve of claim 14, wherein an elastomer is contained within a porous structure of the expanded fluoropolymer membrane layer, coated on one or both sides of the expanded fluoropolymer membrane layer, or a combination of coated on and contained within the expanded fluoropolymer membrane layer.

16. The prosthetic valve of claim 15, wherein the elastomer comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

17. The prosthetic valve of claim 15, wherein the expanded fluoropolymer membrane layer comprises ePTFE.

18. The prosthetic valve of claim 1, wherein the leaflet construct comprises a laminate having more than one fluoropolymer membrane layers.

19. The prosthetic valve of claim 1, wherein the leaflet frame comprises a metal.

20. The prosthetic valve of claim 1, wherein the leaflet construct 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.

21. The prosthetic valve of claim 20, wherein the composite material comprises fluoropolymer membrane by weight in a range of about 10% to 90%.

22. The prosthetic valve of claim 20, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

23. The prosthetic valve of claim 20, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

24. The prosthetic valve of claim 20, wherein the fluoropolymer membrane layer comprises ePTFE.

25. The prosthetic valve of claim 20, wherein the elastomer is silicone.

26. The prosthetic valve of claim 20, wherein the elastomer is a fluoroelastomer.

27. The prosthetic valve of claim 20, wherein the elastomer is a urethane.

28. The prosthetic valve of claim 20, wherein the elastomer is a TFE/PMVE copolymer.

29. The prosthetic valve of claim 28, 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.

30. A prosthetic valve, comprising:

a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side opposite the leaflet frame inner side, the leaflet frame further defining a plurality of commissure posts, each commissure post having a post outer side and a post inner side opposite the post outer side, the commissure posts are defined by a first post leg and a second post leg separated by a post slot therebetween;

a leaflet construct defining a seamless cylinder defining a plurality of leaflets and a bridge region between each of the leaflets, each bridge region defining a bridge first end adjacent a first leaflet and a bridge second end adjacent a second leaflet; and

a plurality of retention elements, each retention element having a retention element inner side and a retention element outer side opposite the retention element inner side, the retention element inner side defining a dividing line bisecting the retention element,

wherein each bridge region is wrapped around the retention element outer side to the retention element inner side of one of the retention elements with the bridge first end wrapped across the retention element inner side to adjacent the dividing line from a first direction and the bridge second end wrapped across the retention element inner side to adjacent the dividing line from an opposite direction, wherein the bridge first end and bridge second end are adjacent to each other to define a coaptation neck,

wherein each of the coaptation necks passes through one of the post slots with the retention element adjacent the post outer side and wherein the leaflets extend from the leaflet frame inner side.

31. The prosthetic valve of claim 30, wherein the leaflets extend from the post slot in a direction perpendicular to the post inner side.

32. The prosthetic valve of claim 30, wherein the leaflet construct is mechanically coupled to the commissure post at the post outer side.

33. The prosthetic valve of claim 30, wherein the leaflet construct defines a seamless annular ring.

34. The prosthetic valve of claim 30, wherein the leaflet construct is mechanically coupled to the leaflet frame with fabric therebetween, and wherein the leaflet frame is coupled to a base frame.

35. The prosthetic valve of claim 30, wherein the retention element is substantially flat.

36. The prosthetic valve of claim 30, wherein the retention element has a width that is larger than a width of the post slot.

37. A prosthetic valve, comprising:

a leaflet frame defining a cylinder having a leaflet frame inner side and a leaflet frame outer side, the leaflet frame having a leaflet frame central axis and a plurality of commissure posts extending parallel to the leaflet frame central axis that are spaced from one another, each commissure post defining a post slot therethrough that is aligned parallel to the leaflet frame central axis, between the commissure posts and contiguous therewith is a leaflet window;

a leaflet construct defining a contiguous cylinder comprising a plurality of leaflets and a bridge region between each of the leaflets, the leaflets extend inward from the leaflet frame, each of the leaflets defining a fold-over portion that is folded over and lies against the leaflet frame outer side of the leaflet frame and coupled thereto, each of the bridge regions extending through one of the post slots and defining a bridge loop that is adjacent to the leaflet frame outer side; and

a retention element having a width that is larger than a width of the post slot, the retention element being disposed in the bridge loop and operable to prevent the bridge loop from passing through the post slot;

wherein the leaflet frame includes a plurality of frame apertures and wherein the commissure posts include a plurality of post apertures that pass through the leaflet frame from the leaflet frame inner side to the leaflet frame outer side and that are spaced from one another, and wherein each retention element includes a plurality of retention element apertures each of which is aligned with a respective one of the post apertures in a respective commissure post.