Frame with integral sewing cuff for prosthetic valves

• US 10,314,697 B2
• Filed: 08/13/2015
• Issued: 06/11/2019
• Est. Priority Date: 08/18/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Inventors: Gassler, Paul D.
• Primary Examiner(s): Sharma, Yashita
• Application Number:
  US15/502,871
• Publication Number:
  US 20170231757A1
• Time in Patent Office: 1,398 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/007 O-rings

Abstract

Described embodiments are related to a prosthetic valve for surgical placement with a sewing cuff durably attached to a frame. The durability of the attachment is accomplished by sandwiching a fabric between the frame and a composite material. The fabric extends beyond the frame base to form a sewing cuff that is integral to a frame assembly. The sewing cuff facilitates tissue ingrowth while tissue ingrowth is discouraged elsewhere around the frame.

Claims

1. A prosthetic valve frame assembly, comprising:

a frame defining a tubular shape;

a fabric having fabric pores, the fabric defining a fabric frame portion and a sewing cuff opposite the fabric frame portion, wherein the fabric frame portion has an elastomer present in the fabric pores and wherein the sewing cuff does not have an elastomer present in the fabric pores, the fabric frame portion being coupled to the frame; and

a composite material coupled to at least a portion of the fabric frame portion with the fabric frame portion disposed between the frame and the composite material, the sewing cuff extending from the frame.

2. The prosthetic valve frame assembly of claim 1, the frame having a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface, the fabric frame portion disposed between the frame inside surface and the composite material.

3. The prosthetic valve frame assembly of claim 1, the frame having a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame outside surface, the fabric frame portion disposed between the frame outside surface and the composite material.

4. The prosthetic valve frame assembly of claim 1, the frame having a frame inside surface and a frame outside surface opposite the frame inside surface, the fabric frame portion being coupled to the frame inside surface and the frame outside surface, the fabric frame portion disposed between the frame inside surface and the composite material, and the fabric frame portion disposed between the frame outside surface and the composite material.

5. The prosthetic valve frame assembly of claim 1, the frame having a frame inside surface and a frame outside surface opposite the frame inside surface, wherein the fabric defines a fabric first end, a fabric second end opposite the fabric first end, and a fabric central portion between the fabric first end and the fabric second end, wherein the fabric frame portion comprises the fabric first end and the fabric second end, and wherein the sewing cuff is defined by a fold in the fabric central portion, wherein the fabric first end is coupled to the frame inside surface and the fabric second end is coupled to the frame outside surface, wherein the composite material comprises an inner composite material being coupled to the fabric first end with the fabric first end disposed between the frame inside surface and the inner composite material, and the composite material comprises an outer composite material being coupled to the fabric second end with the fabric second end disposed between the frame outside surface and the outer composite material.

6. The prosthetic valve frame assembly of claim 5, further comprising a filler material in the fold of the fabric central portion providing bulk to the sewing cuff.

7. The prosthetic valve frame assembly of claim 1, wherein the frame defines a frame base, wherein the sewing cuff extends from the frame base.

8. The prosthetic valve frame assembly of claim 7, the frame further comprising two or more frame strut elements extending from the frame base and defining a plurality of leaflet windows adjacent the frame base.

9. The prosthetic valve frame assembly of claim 8, wherein the composite material extends from the fabric frame portion into each of the leaflet windows defining leaflets therein.

10. The prosthetic valve frame assembly of claim 8, wherein the fabric frame portion extends from the frame base to at least a portion of the frame strut elements.

11. The prosthetic valve frame assembly of claim 8, wherein the fabric frame portion extends from the frame base to substantially all of the frame strut elements.

12. The prosthetic valve frame assembly of claim 8, wherein the fabric frame portion extends from the frame base to beyond the frame strut elements that define the leaflet windows extending at least partially into the leaflet windows.

13. The prosthetic valve frame assembly of claim 8, wherein the fabric frame portion is coupled to the frame at the frame base.

14. The prosthetic valve frame assembly of claim 8, further comprising a leaflet coupled to the frame at each of the plurality of leaflet windows.

15. The prosthetic valve frame assembly of claim 8, wherein the composite material comprises a membrane having a porous structure and an elastomer present in the porous structure.

16. The prosthetic valve frame assembly of claim 1, wherein the sewing cuff is comprised of two or more layers of the fabric.

17. The prosthetic valve frame assembly of claim 16, wherein the sewing cuff further comprises a filler material between the two or more layers of the fabric.

18. The prosthetic valve frame assembly of claim 1, wherein the composite material comprises at least one fluoropolymer layer having fluoropolymer membrane pores and an elastomer present in the fluoropolymer membrane pores.

19. The prosthetic valve frame assembly of claim 1, wherein the fabric comprises polyethylene terephthalate.

20. The prosthetic valve frame assembly of claim 1, wherein the fabric comprises PTFE.

21. The prosthetic valve frame assembly of claim 1, wherein the fabric is comprised of a single fabric piece.

22. The prosthetic valve frame assembly of claim 1, wherein the fabric is comprised of two or more fabric pieces which are coupled together.

23. The prosthetic valve frame assembly of claim 22, wherein the two or more fabric pieces are coupled by being sewn together.

24. The prosthetic valve frame assembly of claim 23, wherein the two or more fabric pieces are coupled by an adhesive.

25. The prosthetic valve frame assembly of claim 1, wherein the sewing cuff is operable to facilitate tissue ingrowth.

26. The prosthetic valve frame assembly of claim 1, further comprising leaflets coupled to the frame.