LAMINATED SEALING MEMBER FOR PROSTHETIC HEART VALVE

• US 20160317305A1
• Filed: 04/27/2016
• Published: 11/03/2016
• Est. Priority Date: 04/29/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Nir, Noam, Pelled, Itai, Sherman, Elena, Goldberg, Eran, Rupp, Kevin D.
• Granted Patent: US 10,232,564 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: B29C 66/53245 said articles being hollow

Abstract

The present disclosure relates to laminated sealing members for prosthetic valves and methods of making the same. In a representative embodiment, an implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration comprises an annular frame having an inflow end and an outflow end, a leaflet structure positioned within the frame and secured thereto, and a laminate sealing member comprising an encapsulating material. The laminate sealing member has a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame, and the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

Claims

1. An implantable prosthetic valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic valve comprising:

an annular frame having an inflow end and an outflow end;

a leaflet structure positioned within the frame and secured thereto; and

a laminate sealing member comprising an encapsulating material, the laminate sealing member having a main portion that encapsulates at least a portion of the frame and an end portion extending from the inflow end of the frame;

wherein the end portion of the laminate sealing member is folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.

2. The assembly of claim 1, wherein the laminate sealing member comprises a first tubular layer positioned on the inside of the frame and a second tubular layer positioned on the outside of the frame, the first and second tubular layers being fused together to encapsulate corresponding portions of the frame.

3. The assembly of claim 2, wherein the first tubular layer, the second tubular layer, or both extend from the inflow end of the frame to form the cuff.

4. The assembly of claim 2, further comprising a reinforcing layer positioned adjacent the frame and encapsulated between the first and second tubular layers.

5. The assembly of claim 4, wherein the leaflet structure is sutured to the reinforcing layer.

6. The assembly of claim 4, wherein the reinforcing layer comprises a fabric.

7. The assembly of claim 4, wherein the reinforcing layer comprises a semi-crystalline polymeric material.

8. The assembly of claim 1, wherein the end portion of the laminate sealing member comprises extension portions secured to the main portion of the laminate sealing member.

9. The assembly of claim 1, wherein the end portion of the laminate sealing member is secured to the main portion of the laminate sealing member by heat bonding.

10. The assembly of claim 1, wherein the end portion of the laminate sealing member is secured to the main portion of the laminate sealing member by suturing.

11. The assembly of claim 1, wherein the laminate sealing member comprises a non-absorbable polymer selected from expanded polytetrafluoroethylene, unexpanded porous polytetrafluoroethylene, ultrahigh molecular weight polyethylene, or any combination thereof.

12. A method of making a prosthetic heart valve, comprising:

positioning a first layer about a mandrel;

positioning a radially expandable frame over the first layer;

positioning a second layer over the radially expandable frame;

fusing the first and second layers to form a monolithic laminate sealing member such that at least a portion of the frame is encapsulated within the laminate sealing member; and

folding an end portion of the laminate sealing member and securing it to a main portion of the laminate sealing member to form a cuff adjacent an inflow end of the frame.

13. The method of claim 12, wherein the fusing further comprises:

applying pressure to force the second layer and the first layer into contact with one another; and

heating the first and second layers so that they fuse together to form the laminate sealing member encapsulating the frame.

14. The method of claim 12, further comprising positioning a reinforcing layer adjacent the frame between the first and second layers.

15. The method of claim 14, wherein the reinforcing layer comprises at least one of a fabric material, a textile material, or a semi-crystalline polymeric material.

16. The method of claim 12, wherein securing the end portion of the laminate sealing member to the main portion of the laminate sealing member further comprises heat bonding the end portion of the laminate sealing member to the main portion of the laminate sealing member.

17. The method of claim 12, wherein securing the end portion of the laminate sealing member to the main portion of the laminate sealing member further comprises suturing the end portion of the laminate sealing member to the main portion of the laminate sealing member.

18. The method of claim 12, wherein securing the end portion of the laminate sealing member to the main portion of the laminate sealing member further comprises securing extension portions of the end portion of the laminate sealing member to the main portion of the laminate sealing member.

19. The method of claim 12, further comprising situating a valvular structure within the frame and securing the valvular structure to the laminate sealing member and the frame.

20. A transcatheter heart valve, comprising:

a radially expandable frame having an inflow end, an outflow end, and a laminate sealing member comprising;

a non-fabric inner layer positioned inside of the frame;

a non-fabric outer layer positioned outside of the frame; and

a fabric layer positioned between the non-fabric inner layer and the non-fabric outer layer, the non-fabric inner and outer layers being fused to one another such that the fabric layer and at least a portion of the frame are encapsulated therebetween;

wherein the laminate sealing member further comprises a main portion adjacent the frame and an end portion extending from the inflow end of the frame, the end portion being folded to form a cuff adjacent the inflow end of the frame and secured to the main portion of the laminate sealing member.