Laminated sealing member for prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-11298889-B2
Application number	US-201916294761-A
Country	US
Kind code	B2
Filing date	Mar 6, 2019
Priority date	Apr 29, 2015
Publication date	Apr 12, 2022
Grant date	Apr 12, 2022

Abstract

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.

First claim

The invention claimed is:

1. A prosthetic heart valve, comprising:
an annular frame that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having an inflow end and an outflow end, and defining a longitudinal axis along a lumen of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration;
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 inner and outer layers being heat-bonded together to encapsulate at least a portion of the frame;
wherein, on the outside of the frame, the outer layer extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the outer layer is secured to the outer layer downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

2. The prosthetic heart valve of claim 1 , wherein the outer layer extends beyond the inflow end of the frame in the upstream direction along the longitudinal axis, and the fold line is offset from the inflow end of the frame in the upstream direction along the longitudinal axis.

3. The prosthetic heart valve of claim 1 , wherein the cuff comprises a first layer and a second layer, the second layer being radially outward of the first layer, the first and second layers being formed by the outer layer of the laminate sealing member on the outside of the frame.

4. The prosthetic heart valve of claim 1 , wherein the edge portion of the outer layer is secured to the outer layer at a location between the inflow end of the frame and the outflow end of the frame.

5. The prosthetic heart valve of claim 1 , wherein the cuff defines a pocket extending circumferentially around the frame, the pocket being fluidly isolated from the lumen of the prosthetic heart valve.

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

7. The prosthetic heart valve of claim 6 , wherein the leaflet structure is sutured to the reinforcing layer.

8. The prosthetic heart valve of claim 6 , wherein the reinforcing layer comprises a fabric or a semi-crystalline polymeric material.

9. The prosthetic heart valve of claim 6 , wherein the inner and outer layers are heat-bonded to each other through openings in the frame upstream and downstream of the reinforcing layer to encapsulate the reinforcing layer.

10. The prosthetic heart valve of claim 1 , wherein the edge portion of the outer layer comprises extension portions secured to the outer layer between the inflow end and the outflow end of the frame to form the cuff.

11. The prosthetic heart valve of claim 1 , wherein the edge portion of the outer layer is secured to the outer layer by heat-bonding to form the cuff.

12. The prosthetic heart valve of claim 1 , wherein the edge portion of the outer layer is secured to the outer layer by suturing to form the cuff.

13. The prosthetic heart valve of claim 1 , wherein a lower edge of the leaflet structure is offset from the inflow end of the frame in a downstream direction toward the outflow end of the frame.

14. The prosthetic heart 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.

15. A transcatheter heart valve, comprising:
a radially expandable frame having an inflow end, an outflow end, and defining a longitudinal axis along a lumen of the transcatheter heart valve when the transcatheter heart valve is radially expanded; and
a laminate sealing member comprising:
a non-fabric inner layer disposed inside of the frame;
a non-fabric outer layer disposed outside of the frame; and
a fabric layer disposed 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, on the outside of the frame, the non-fabric outer layer extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame at a fold line to form a cuff, and an edge portion of the non-fabric outer layer is secured to the non-fabric outer layer downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member.

16. A method of making a prosthetic heart valve, comprising:
positioning an inner layer about a mandrel;
positioning an annular frame over the inner layer, the frame being radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame having an inflow end and an outflow end, and defining a longitudinal axis along a lumen of the prosthetic heart valve when the prosthetic heart valve is in the expanded configuration;
positioning an outer layer over the frame such that an edge portion of the outer layer extends beyond the inflow end of the frame along the longitudinal axis;
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 the laminate sealing member;
folding the edge portion of the outer layer such that the outer layer extends along the longitudinal axis in an upstream direction and doubles back on the outside of the frame toward the outflow end of the frame at a fold line to form a cuff;
securing the edge portion of the outer layer to the outer layer downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member;
positioning a leaflet structure within the frame; and
securing the leaflet structure to the frame.

17. The method of claim 16 , 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.

18. The method of claim 16 , further comprising positioning a reinforcing layer adjacent the frame between the inner and outer layers, the reinforcing layer comprising at least one of a fabric material, a textile material, or a semi-crystalline polymeric material.

19. The method of claim 16 , wherein securing the edge portion of the outer layer to the outer layer further comprises heat bonding the edge portion of the outer layer to the outer layer between the inflow end of the frame and the outflow end of the frame.

20. The method of claim 16 , wherein securing the edge portion of the outer layer to the outer layer further comprises securing extension portions of the edge portion of the outer layer to the outer layer.

Assignees

• Edwards Lifesciences Corp

Inventors

• Pelled Itai
• Sherman Elena
• Goldberg Eran
• Rupp Kevin D
• Nir Noam

Classifications

• A61F2210/0076

  multilayered, e.g. laminated structures · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2433

  using balloon catheter · CPC title