Encapsulated heart valves

Patent metadata

Field	Value
Publication number	US-11517426-B2
Application number	US-202016773860-A
Country	US
Kind code	B2
Filing date	Jan 27, 2020
Priority date	May 20, 2011
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

The present disclosure concerns embodiments of implantable prosthetic devices, and in particular, implantable prosthetic valves, and methods for making such devices. In one aspect, a prosthetic device includes encapsulating layers that extend over a fabric layer and secure the fabric layer to another component of the device. In particular embodiments, the prosthetic device comprises a prosthetic heart valve, and can be configured to be implanted in any of the native heart valves. In addition, the prosthetic heart valve can be, for example, a transcatheter heart valve, a surgical heart valve, or a minimally-invasive heart valve.

First claim

We claim:

1. An encapsulated implantable prosthetic heart valve, comprising:
a radially collapsible and expandable annular frame;
a fabric layer adjacent the annular frame to form a subassembly;
a first tubular covering member placed within the subassembly;
a second tubular covering member positioned over the subassembly and the first covering member so that the second covering member is coextensive with the first covering member, wherein the first and second tubular covering members are fused together by heat and pressure to form a monolithic covering that at least partially encapsulates the subassembly to form an encapsulated annular frame; and
valvular leaflets positioned within the encapsulated annular frame and sutured to the fabric layer, the valvular leaflets being configured to permit blood flow in a first direction through the heart valve and block blood flow through the heart valve in a second direction, opposite the first direction.

2. The heart valve of claim 1 , wherein the fabric layer comprises an annular skirt disposed on the frame.

3. The heart valve of claim 2 , wherein the annular frame comprises a plurality of frame members defining a plurality of gaps between the frame members, and the annular skirt is configured to prevent blood from flowing through gaps in the frame that are covered by the annular skirt.

4. The heart valve of claim 3 , wherein the annular skirt extends only partway along the annular frame from a first end to a midpoint thereof, and portions of the first and second covering members between the midpoint and a second end of the annular frame are removed to facilitate crimping of the valve for subsequent delivery into a patient.

5. The heart valve of claim 1 , wherein the first and second covering members are substantially the same length as the frame.

6. The heart valve of claim 1 , wherein the first and second covering members are non-absorbable and have a porous microstructure that promotes ingrowth of surrounding tissue to assist in securing the prosthetic heart valve in a body lumen.

7. The heart valve of claim 6 , wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

8. The heart valve of claim 7 , wherein the fabric layer is a PET cloth and the first and second covering members comprise ePTFE.

9. The heart valve of claim 1 , wherein the fabric layer is disposed on the outside of the frame.

10. The heart valve of claim 9 , wherein a second fabric layer is also disposed on the inside of the frame.

11. The heart valve of claim 1 , further including a reinforcing strip secured to inner surfaces of lower edges of each of the leaflets, sandwiching the lower edges between the reinforcing strips and the fabric layer and suturing the lower edges of the leaflets to the skirt.

12. An encapsulated implantable prosthetic heart valve, comprising:
a radially collapsible and expandable annular frame partially crimped from an expanded size having a first diameter to a smaller partially crimped size having a second diameter;
an annular fabric skirt positioned around the partially crimped frame, the skirt being formed in a tubular configuration having a skirt diameter smaller than the first diameter;
wherein the frame is expanded to an expanded size such that the expanded frame applies outward radial pressure against the skirt to retain the skirt on the frame, the expanded frame and skirt retained thereon forming a subassembly;
a first tubular covering member placed within the subassembly;
a second tubular covering member positioned over the subassembly and the first covering member so that the second tubular covering member at least partly covers the subassembly and is coextensive with the first tubular covering member, wherein the first and second tubular covering members are fused together by heat and pressure to form a monolithic covering that at least partially encapsulates the subassembly to form an encapsulated annular frame; and
valvular leaflets positioned within the encapsulated annular frame and sutured to the skirt, the valvular leaflets being configured to permit blood flow in a first direction through the heart valve and block blood flow through the heart valve in a second direction, opposite the first direction.

13. The heart valve of claim 12 , wherein the first and second tubular covering members are non-absorbable and have a porous microstructure that promotes ingrowth of surrounding tissue to assist in securing the prosthetic heart valve in a body lumen.

14. The heart valve of claim 11 , wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

15. The heart valve of claim 14 , wherein the skirt is a PET cloth and the first and second covering members comprise ePTFE.

16. The heart valve of claim 12 , wherein the skirt is completely encapsulated by the monolithic covering formed by the first and second tubular covering members.

17. The heart valve of claim 12 , wherein the annular frame comprises a plurality of frame members defining a plurality of gaps between the frame members, and wherein the first and second tubular covering members are formed with gaps that correspond to gaps in the frame that are not covered by the skirt.

18. The heart valve of claim 12 , wherein an inflow end of the skirt is aligned with an inflow end of the annular frame and a portion of the annular frame between an outflow end of the skirt and an outflow end of the annular frame is not covered by the first and second tubular covering members.

19. The heart valve of claim 12 , wherein a second annular fabric skirt is also disposed on the inside of the frame.

20. The heart valve of claim 12 , wherein the radially collapsible and expandable tubular frame is formed of a material that is plastically expandable.

21. The heart valve of claim 12 , wherein the radially collapsible and expandable tubular frame is formed of a material that is self-expandable.

Assignees

• Edwards Lifesciences Corp

Inventors

• Bonyuet Celeste C
• Walls Andrew L
• Migliazza John F
• Pelled Itai

Classifications

• A61F2/2418

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

• A61F2/2409

  Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442) · CPC title

• A61F2002/0086

  for preferentially controlling or promoting the growth of specific types of cells or tissues · CPC title

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• Y10T29/49826

  Assembling or joining · CPC title