Laminated sealing member for prosthetic heart valve

• US 10,232,564 B2
• Filed: 04/27/2016
• Issued: 03/19/2019
• Est. Priority Date: 04/29/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Pelled, Itai, Sherman, Elena, Goldberg, Eran, Rupp, Kevin D., Nir, Noam
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US15/140,387
• Publication Number:
  US 20160317305A1
• Time in Patent Office: 1,056 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 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 inner layer positioned on the inside of the frame and an outer layer positioned on the outside of the frame, the outer layer including an inflow end portion comprising an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the inflow end portion of the outer layer extending from the inflow end of the frame, the inner and outer layers being heat-bonded together to form a main portion of the laminate sealing member that encapsulates corresponding portions of the frame;

wherein the inflow end portion of the outer layer is folded to form a cuff adjacent the inflow end of the frame such that the outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the outer layer and forms a double layer on the exterior of the frame, and wherein the inflow edge of the outer layer is secured to the main body portion of the outer layer downstream of the fold line.

2. The prosthetic valve of claim 1, further comprising a reinforcing layer positioned adjacent the frame and encapsulated between the inner and outer layers.

3. The prosthetic valve of claim 2, wherein the leaflet structure is sutured to the reinforcing layer.

4. The prosthetic valve of claim 2, wherein the reinforcing layer comprises a fabric.

5. The prosthetic valve of claim 2, wherein the reinforcing layer comprises a semi-crystalline polymeric material.

6. The prosthetic valve of claim 1, wherein the inflow end portion of the outer layer comprises extension portions secured to the main body portion of the outer layer.

7. The prosthetic valve of claim 1, wherein the inflow edge of the outer layer is secured to the main body portion of the outer layer by heat bonding.

8. The prosthetic valve of claim 1, wherein the inflow edge of the outer layer is secured to the main body portion of the outer layer by suturing.

9. The prosthetic valve 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.

10. The prosthetic heart valve of claim 1, wherein the entire inflow end portion of the outer layer is radially outward of an inflow end portion of the inner layer.

11. The prosthetic heart valve of claim 1, wherein the fold line of the outer layer is radially outward of an outer surface of the main body portion of the outer layer.

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

positioning an inner layer about a mandrel;

positioning an annular radially expandable and collapsible frame over the inner layer such that the inner layer is positioned on the inside of the frame, the frame having an inflow end and an outflow end;

positioning an outer layer over the frame, the outer layer including an inflow end portion comprising an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the outer layer being positioned such that the outer layer is on the outside of the frame, and such that the inflow end portion of the outer layer extends beyond the inflow end of the frame;

heat-bonding the inner and outer layers to form a monolithic laminate sealing member such that at least a portion of the frame is encapsulated within a main portion of the laminate sealing member;

folding the inflow end portion of the outer layer to form a cuff adjacent the inflow end of the frame such that the outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the outer layer and forms a double layer on the exterior of the frame;

securing the inflow edge of the outer layer to the main body portion of the outer layer downstream of the fold line;

positioning a leaflet structure within the frame; and

securing the leaflet structure to the frame.

13. The method of claim 12, wherein the heat-bonding further comprises:

applying pressure to force the outer layer and the inner layer into contact with one another; and

heating the inner and outer layers so that they heat-bond 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 inner and outer 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 inflow edge of the outer layer to the main body portion of the outer layer further comprises heat bonding the inflow edge of the outer layer to the main body portion of the outer layer.

17. The method of claim 12, wherein securing the inflow edge of the outer layer to the main body portion of the outer layer further comprises suturing the inflow edge of the outer layer to the main body portion of the outer layer.

18. The method of claim 12, wherein securing the inflow edge of the outer layer to the main body portion of the outer layer further comprises securing extension portions of the inflow end portion of the outer layer to the main body portion of the outer layer.

19. 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, the non-fabric outer layer comprising an inflow end portion including an inflow edge, an outflow end portion comprising an outflow edge, and a main body portion extending between the inflow end portion and the outflow end portion, the inflow end portion of the non-fabric outer layer extending beyond the inflow end 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 heat-bonded to one another such that the fabric layer and at least a portion of the frame are encapsulated therebetween;

wherein the inflow end portion of the non-fabric outer layer is folded to form a cuff adjacent the inflow end of the frame such that the non-fabric outer layer forms a fold line at an upstream-most end of the outer layer and doubles back on the outside of the frame so that the cuff extends from the fold line in a downstream direction along an outer surface of the main body portion of the non-fabric outer layer and forms a double layer on the exterior of the frame, and wherein the inflow edge of the non-fabric outer layer is secured to the main body portion of the non-fabric outer layer downstream of the fold line.

20. The transcatheter heart valve of claim 19, wherein the fold line of the outer layer is radially outward of an outer surface of the main body portion of the outer layer.