Methods of making encapsulated heart valves

• US 10,045,846 B2
• Filed: 04/18/2014
• Issued: 08/14/2018
• Est. Priority Date: 05/20/2011
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Bonyuet, Celeste C., Walls, Andrew L., Migliazza, John F., Pelled, Itai
• Primary Examiner(s): Schatz, Christopher T
• Application Number:
  US14/256,747
• Publication Number:
  US 20140209238A1
• Time in Patent Office: 1,579 Days
• 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 of bone tissue onto implantable joints A61F2002/3093
• 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:

placing a first tubular covering member on a mandrel;

placing a radially collapsible and expandable annular frame over the first covering member on the mandrel so that the first covering member extends within the annular frame;

placing a fabric layer over the annular frame;

temporarily securing the location and placement of the fabric layer on the annular frame with at least one layer of first tape and without using sutures to form a subassembly of the fabric skirt and annular frame;

removing the at least one layer of tape;

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;

securing the position of the second covering member to the subassembly, first covering member and mandrel with at least one layer of second tape;

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

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 a leaflet support without using sutures; and

suturing valvular leaflets to the fabric layer in 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.

2. The method of claim 1, wherein the valvular leaflets comprise bovine pericardial tissue.

3. The method of claim 1, wherein the fabric layer comprises an annular skirt disposed on the frame.

4. The method of claim 3, wherein the annular frame comprises a plurality of frame members defining a plurality of gaps between the frame members, and the fabric layer comprises an the annular 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 step of heating comprises sintering to a temperature above 327 degrees C., allowing the assembly to cool, and removing the at least one layer of second tape.

6. The method of claim 1, further including trimming portions of the first and second covering members that extend beyond opposite ends of the frame so that the first and second tubular covering members are substantially the same length as the frame.

7. The method of claim 1, further including removing selected portions of the first and second covering members to facilitate crimping of the valve for subsequent delivery into a patient.

8. 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.

9. The method of claim 8, wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

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

placing a first tubular covering member on a mandrel;

partially crimping a radially collapsible and expandable annular frame from an expanded size having a first diameter to a smaller crimped size having a second diameter;

positioning an annular fabric skirt around the partially crimped frame, the annular fabric skirt being preformed in a tubular configuration having a skirt diameter smaller than the first diameter;

expanding the frame to an expanded size such that the expanded frame applies at least some outward radial pressure against the skirt to retain the skirt on the frame, the expanded frame and skirt retained thereon forming a subassembly;

placing the subassembly over the first tubular covering member on the mandrel;

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

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

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 without using sutures; and

suturing valvular leaflets to the fabric skirt in 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.

11. The method of claim 10, wherein the valvular leaflets comprise bovine pericardial tissue.

12. The method of claim 10, 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.

13. The method of claim 12, wherein the first and second tubular covering members comprise ePTFE or UHMWPE.

14. The method of claim 10, wherein the fabric skirt is completely encapsulated by the monolithic covering formed by the first and second tubular covering members.

15. The method of claim 10, 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.

16. The method of claim 10, 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 first and second tubular covering members.

17. The method of claim 10, wherein the step of heating comprises sintering to a temperature above 327 degrees C., allowing the assembly to cool, and trimming portions of the first and second tubular covering members that extend beyond opposite ends of the frame so that the first and second tubular covering members are substantially the same length as the frame.

18. The method of claim 17, further including removing selected portions of the first and second tubular covering members to facilitate crimping of the valve for subsequent delivery into a patient.

19. The method of claim 18, wherein the step of removing the selected portions comprises removing portions that cover gaps in the frame.

20. The method of claim 18, wherein the step of removing the selected portions comprises removing portions extending from an outflow edge of the skirt to an outflow edge of the frame to expose struts of the frame that extend beyond the outflow edge of the skirt.