MULTI-FRAME PROSTHETIC VALVE APPARATUS AND METHODS

• US 20140031927A1
• Filed: 03/12/2013
• Published: 01/30/2014
• Est. Priority Date: 07/27/2012
• 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.
• Granted Patent: US 10,376,360 B2
• Time in Patent Office: Days
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame coaxially disposed within a body frame, as well as methods of making the valve devices.

Claims

1. A valve comprising

a body frame defining 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 leaflet frame being located coaxial with and at least substantially within the body frame lumen;

a first film coupled to the body frame; and

a second film coupled to and extending across each of the U-shaped portions defining a leaflet, each leaflet having a leaflet free edge, at least one of the first film and second film at least partially coupling the body frame to the leaflet frame, wherein the leaflet free edges are operable to abut adjacent leaflet free edges and are moveable between an open and closed position.

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

3. The valve of claim 1, wherein the first film and second film sandwiches the body frame and the leaflet frame.

4. The valve of claim 1, wherein at least one of the first film and second film comprises a laminate having more than two fluoropolymer layers.

5. The valve of claim 4, wherein at least one of the first film and second film comprises a laminate having more than two fluoropolymer layers.

6. The valve of claim 5, wherein the fluoropolymer layer comprises expanded fluoropolymer.

7. The valve of claim 6, wherein the expanded fluoropolymer is imbibed with an elastomer.

8. The valve of claim 7, wherein the elastomer comprises perfluoromethyl vinyl ether and tetrafluoroethylene.

9. The valve of claim 6, wherein the expanded fluoropolymer comprises ePTFE.

10. The valve of claim 1, wherein an aspect ratio of a length of the valve to a functional diameter of the valve is less than 1.

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

12. The valve of claim 1, wherein the leaflet frame inwardly flexes during operation.

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

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

15. The valve of claim 1, wherein the second film 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.

16. The valve of claim 15, wherein the composite material comprises comprises fluoropolymer membrane by weight in the range of about 10% to 90%.

17. The valve of claim 15, wherein the elastomer comprises (per)fluoroalkylvinylethers (PAVE).

18. The valve of claim 15, wherein the elastomer comprises a copolymer of tetrafluoroethylene and perfluoromethyl vinyl ether.

19. The valve of claim 15, wherein the fluoropolymer membrane comprises ePTFE.

20. The valve of claim 1, wherein the first film and the second film are the same.

21. The valve of claim 1, wherein the composition of the first film and the second film are different.

22. A method of making a multi-frame prosthetic valve comprising:

forming a first layer of a second film into a tubular form;

placing a leaflet frame proximate the first layer of the second film;

forming a second layer of a second film over the leaflet frame and the first layer of the second film, wherein the tubular form comprises the first and second layers;

clamping the tubular form to shape leaflets;

forming a third layer of a first film over the leaflet frame;

placing a body frame about the third layer of the first film and over the leaflet frame; and

placing a fourth layer of the first film over the body frame.

23. The method of claim 22, wherein placing a body frame comprises placing a body frame defining a generally tubular shape defining a body frame lumen;

wherein placing a leaflet frame comprises placing a leaflet frame having a generally annular shape defining a plurality of U-shaped portions each defining a base and a plurality of posts;

wherein forming a second layer of a second film over the leaflet frame and the first layer of the second film comprises wrapping a second film onto and extending across each of the U-shaped portions so as to define a leaflet therein, each leaflet having a leaflet free edge;

wherein placing a body frame over the leaflet frame comprises placing the body frame over the leaflet frame such that the leaflet frame is coaxially disposed within the body frame lumen;

wherein forming a third layer of a first film around the leaflet frame comprises wrapping a first film onto and extending across each of the U-shaped portions; and

wherein placing a fourth layer of a first film over the body frame comprises wrapping a first film onto and around the body frame.

24. A method of making a multi-frame prosthetic valve comprising:

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

providing a leaflet frame having a generally annular shape defining a plurality of U-shaped portions each defining a base and a plurality of posts;

providing a film;

forming a first layer of the film into a tubular form;

coaxially placing the leaflet frame over the tubular form of the first layer of film;

wrapping the film around the leaflet frame and the tubular form of the first layer of film, the film extending across each of the U-shaped portions so as to define a leaflet therein;

bonding the first layer and the second layer to each other and the leaflet frame;

clamping the leaflets disposed in the U-shaped portions to enclose the leaflets;

forming a third layer of the film over the leaflet frame;

placing the body frame over the third layer of the film and over the leaflet frame such that the leaflet frame is coaxially disposed within the body frame lumen forming a fourth layer of the film over the body frame and the third layer of the film; and

bonding the third layer and the fourth layer to each other and the body frame.

25. The method of claim 24, wherein forming one or more of the first, second, third and fourth layers of the film comprises wrapping a plurality of times the one or more of the first, second, third and fourth layers of the film.

26. The method of claim 24, wherein providing a film comprises providing 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