Everting transcatheter valve and methods

• US 9,283,072 B2
• Filed: 03/12/2013
• Issued: 03/15/2016
• Est. Priority Date: 07/25/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Bruchman, William C., Hartman, Cody L.
• Primary Examiner(s): Nguyen, Victor
• Application Number:
  US13/797,633
• Publication Number:
  US 20140031924A1
• Time in Patent Office: 1,099 Days
• Field of Search: 623/2.12, 623/2.17, 623/2.18
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2430/20 for reconstruction of the heart, e.g. heart valves
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: B29C 53/44 rotatable about the axis of the article
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: C08L 27/12 containing fluorine atoms
• CPC Class Codes: Y10T 29/49405 Valve or choke making

Abstract

Described embodiments are directed toward centrally-opening, leaflet valve devices and systems for transcatheter delivery having a two-piece valve body as well as methods of making and delivering the two-piece valve devices. A transcatheter valve is operable to have a collapsed configuration and an expanded configuration. The transcatheter valve can further be operable to have an everted configuration and a non-everted configuration.

Claims

1. A transcatheter valve comprising

a body frame having a generally tubular shape defining a body frame lumen;

a leaflet frame having a generally annular shape defining a plurality of U-shaped portions each defining a base and a plurality of posts, the body frame extending coaxially, adjacent to and spaced apart from the leaflet frame, the base of each U-shaped portion being located proximate to but not in contact with a body frame first end of the body frame with the U-shaped portions of the leaflet frame extending away from the body frame and the posts extending away from body frame, the posts being distal from the body frame first end; and

a film, the film extending across and between the U-shaped portions and the body frame, wherein the film that extends between the body frame and the leaflet frame defines a fold region, wherein the film that extends across each of the U-shaped portions defines a leaflet, wherein the leaflet frame is operable to evert to an everted position by rotating about the fold region to a position in which the leaflet frame is at least partially coaxially disposed at least partially within the body frame lumen, wherein each leaflet is moveable between an open and closed position.

2. The transcatheter valve of claim 1, wherein the body frame is more stiff than the leaflet frame.

3. The transcatheter valve of claim 1, wherein the body frame comprises a clasp configured to hold the leaflet frame in the everted position.

4. The transcatheter valve of claim 1, wherein the film sandwiches the body frame and the leaflet frame.

5. The transcatheter valve of claim 1, wherein the leaflet comprises a polymeric material.

6. The transcatheter valve of claim 5, wherein the leaflet comprises a laminate.

7. The transcatheter valve of claim 6, wherein the laminate has more than two layers of a fluoropolymer membrane.

8. The transcatheter valve of claim 6, wherein the leaflet comprises a composite material having at least one fluoropolymer membrane layer having a plurality of pores and an elastomer present in substantially all of the pores of at least one layer of fluoropolymer membrane.

9. The transcatheter valve of claim 8, wherein the composite material comprises between about 10% to about 80% fluoropolymer membrane by weight.

10. The transcatheter valve of claim 8, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

11. The transcatheter valve of claim 8, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

12. The transcatheter valve of claim 8, wherein the fluoropolymer membrane comprises ePTFE.

13. The transcatheter valve of claim 1, wherein the body frame comprises a non-shape memory material.

14. The transcatheter valve of claim 1, wherein the body frame is a generally tubular member defining a generally open pattern of apertures operable to allow the body frame to be compressed to a collapsed profile and expanded between different diameters.

15. The transcatheter valve of claim 1, wherein an aspect ratio of a length of the transcatheter valve to an expanded diameter of the transcatheter valve is less than 1.

16. The transcatheter valve of claim 1, wherein the body frame is less than about 20 mm in length.

17. The transcatheter valve of claim 1, wherein the leaflet frame comprises a shape-memory material.

18. The transcatheter valve of claim 1, wherein the leaflet frame comprises a metallic material.

19. The transcatheter valve of claim 1, wherein the leaflet frame is formed from a wire.

20. The transcatheter valve of claim 19, the body frame having a body frame inner surface defining the body frame lumen, wherein the at least a portion of the leaflet frame is held adjacent to a body frame inner surface by a spring bias of the leaflet frame.

21. The transcatheter valve of claim 1, wherein the body frame and leaflet frame may be collapsed to define a collapsed profile of less than about 6 mm.

22. The transcatheter valve of claim 1, wherein the transcatheter valve is balloon expandable.