METHODS OF MAKING ENCAPSULATED HEART VALVES

• US 20140209238A1
• Filed: 04/18/2014
• Published: 07/31/2014
• Est. Priority Date: 05/20/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Migliazza, John F., Pelled, Itai, Bonyuet, Celeste C., Walls, Andrew L.
• Granted Patent: US 10,045,846 B2
• Time in Patent Office: Days
• US Class Current: 156/294
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: Y10T 29/49826 Assembling or joining

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.

Claims

1. A method for making an implantable prosthetic heart valve, comprising:

forming a subassembly of the prosthetic heart valve comprising an annular leaflet support and a fabric layer at least partially covering the leaflet support, wherein the fabric layer is either not attached to the leaflet support with sutures or is only attached thereto with sutures at a few selected locations;

placing a first tubular covering member on a mandrel;

placing the subassembly over the first covering member on the mandrel so that the first covering member at least partly extends within the subassembly;

placing a second tubular covering member over the subassembly on the first covering member on the mandrel so that the second covering member at least partly covers the subassembly and is coextensive with the first covering member;

applying pressure to force the second covering member and the first covering member into contact with other; and

heating the first and second tubular covering members so that they fuse together to form a monolithic covering that at least partially encapsulates the subassembly and thereby secures the fabric layer to the leaflet support.

2. The method of claim 1, further comprising suturing valvular leaflets to the monolithic covering and the subassembly, the 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.

3. The method of claim 1, wherein the annular leaflet support comprises an annular frame and the fabric layer comprises an annular skirt disposed on the inside or outside of the frame.

4. The method of claim 3, wherein the annular frame comprises a radially collapsible and expandable annular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of frame members defining a plurality of gaps between the frame members, and the fabric layer comprises an annular fabric skirt positioned adjacent the frame and configured to prevent blood from flowing through gaps in the frame that are covered by the skirt.

5. The method of claim 1, wherein the annular leaflet support comprises a wireform having a plurality of commissure portions and cusp portions extending between adjacent commissure portions.

6. The method of claim 1, wherein the annular leaflet support comprises a stent having a plurality of commissure portions and cusp portions extending between adjacent commissure portions.

7. The method of claim 1, wherein the annular leaflet support comprises a sewing ring.

8. The method of claim 1, wherein there are a plurality of subassemblies having annular leaflet supports and at least partially each encapsulated by a one of the fused monolithic coverings including:

a wireform having a plurality of commissure portions and cusp portions extending between adjacent commissure portions;

a stent having a plurality of commissure portions and cusp portions extending between adjacent commissure portions; and

a sewing ring, and wherein,

the subassemblies are attached together and a plurality of leaflets are secured thereto 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.

9. The method of claim 1, 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.

10. The method of claim 9, wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

11. A method for making an implantable prosthetic heart valve, comprising:

forming a subassembly of the prosthetic heart valve comprising a radially collapsible and expandable annular frame, the frame having an inlet end and outlet end, the frame comprising a plurality of frame members defining a plurality of gaps between the frame members, an annular fabric skirt positioned adjacent the frame and configured to prevent blood from flowing through those gaps in the frame that are covered by the skirt;

placing a first tubular covering member on a mandrel;

placing the subassembly over the first covering member on the mandrel so that the first covering member at least partly extends within the subassembly;

placing a second tubular covering member over the subassembly on the first covering member on the mandrel so that the second covering member at least partly covers the subassembly and is coextensive with the first covering member;

applying pressure to force the second covering member and the first covering member into contact with other; and

heating the first and second tubular covering members so that they fuse together to form a monolithic covering that at least partially encapsulates the subassembly and thereby secures the fabric skirt to the annular frame.

12. The method of claim 11, further comprising suturing valvular leaflets to the monolithic covering and the subassembly, the 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 method of claim 11, 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 method of claim 13, wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

15. The method of claim 11, wherein the fabric skirt is secured to the frame by the covering formed by the inner and outer tubular layers and does not include any sutures to secure the fabric skirt to the frame.

16. The method of claim 11, wherein the fabric skirt is completely encapsulated by the covering formed by the first and second tubular covering members.

17. The method of claim 11, wherein the fabric skirt is disposed on the outside of the frame.

18. The method of claim 11, wherein the fabric skirt is disposed on the inside of the frame.

19. The method of claim 17, wherein the fabric skirt is also disposed on the outside of the frame.

20. The method of claim 11, 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 fabric skirt.

21. The method of claim 11, wherein an inflow end of the fabric skirt is aligned with an inflow end of the frame and a portion of the frame between an outflow end of the skirt and an outflow end of the frame is not covered by the inner and outer tubular layers.