Laminated sealing member for prosthetic heart valve

Patent metadata

Field	Value
Publication number	US-12459213-B2
Application number	US-202217719262-A
Country	US
Kind code	B2
Filing date	Apr 12, 2022
Priority date	Apr 29, 2015
Publication date	Nov 4, 2025
Grant date	Nov 4, 2025

Abstract

A prosthetic heart valve has a radially expandable and collapsible annular frame, the frame having an inflow end and an outflow end and defining a longitudinal axis along a lumen of the prosthetic heart valve when it is in the expanded configuration. A leaflet structure is positioned within the frame and secured thereto. The prosthetic heart valve also has a laminate sealing member including a plurality of layers heat-bonded together to encapsulate at least a portion of the frame. The laminate sealing member 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 laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end 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 a plurality of layers heat-bonded together to encapsulate at least a portion of the frame; wherein the laminate sealing member 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 laminate sealing member is secured to a main portion of the laminate sealing member downstream of the fold line such that the cuff forms an inflow end of the laminate sealing member; and wherein an inflow 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.

2 . The prosthetic heart valve of claim 1 , wherein the laminate sealing member forms a double layer on the outside of the frame.

3 . The prosthetic heart valve of claim 1 , wherein an outer surface of the main portion of the laminate sealing member to which the edge portion is secured is radially outward of the frame.

4 . 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.

5 . The prosthetic heart valve of claim 1 , wherein the laminate sealing member 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.

6 . The prosthetic heart valve of claim 1 , wherein the edge portion of the laminate sealing member is secured to the main portion of the laminate sealing member at a location between the inflow end of the frame and the outflow end of the frame.

7 . 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.

8 . The prosthetic heart valve of claim 1 , further comprising a reinforcing layer positioned adjacent the frame and encapsulated by the laminate sealing member.

9 . The prosthetic heart valve of claim 8 , wherein the leaflet structure is sutured to the reinforcing layer.

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

11 . The prosthetic heart valve of claim 1 , wherein the edge portion of the laminate sealing member comprises extension portions secured to an outer surf ace of the laminate sealing member between the inflow end and the outflow end of the frame to form the cuff.

12 . The prosthetic heart valve of claim 1 , wherein the edge portion of the laminate sealing member is secured to the main portion of the laminate sealing member by heat-bonding or suturing to form the cuff.

13 . The prosthetic heart valve of claim 1 , wherein the laminate sealing member comprises an inner layer positioned on the inside of the frame and an outer layer positioned on the outside of the frame.

14 . The prosthetic heart valve of claim 13 , wherein the inner and outer layers are heat-bonded to each other through openings in the frame upstream and downstream of a reinforcing layer positioned inside the frame to encapsulate the reinforcing layer.

15 . The prosthetic heart valve of claim 13 , wherein the outer layer extends beyond the inflow end of the frame and doubles back at the fold line to form the cuff such that two layers of the outer layer are disposed radially outward of the frame.

16 . The prosthetic heart valve of claim 13 , 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.

17 . A prosthetic heart valve, comprising:
annular frame means that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the frame means 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; leaflet structure means positioned within the frame means and secured thereto; and means for sealing against tissue of a native valve annulus, the sealing means comprising non-fabric polymer layer means heat-bonded together to encapsulate at least a portion of the frame means; wherein the sealing means extends along the longitudinal axis in an upstream direction and doubles back toward the outflow end of the frame means at a fold line to form a cuff, and an edge portion of the sealing means is secured to a main portion of the sealing means downstream of the fold line such that the cuff forms an inflow end of the sealing means.

18 . The prosthetic heart valve of claim 17 , wherein the sealing means forms a double layer on the outside of the frame means.

19 . The prosthetic heart valve of claim 17 , wherein an outer surface of the main portion of the sealing means to which the edge portion is secured is radially outward of the frame means.

Assignees

• Edwards Lifesciences Corp

Inventors

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

Classifications

• A61F2250/0069

  Sealing means · CPC title

• A61F2/2433

  using balloon catheter · CPC title

• A61F2/2418 Primary

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

• A61F2/2415

  Manufacturing methods · CPC title

• A61F2/2412 Primary

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