Prosthetic heart valve including stent structure and tissue leaflets, and related methods

• US 8,353,954 B2
• Filed: 12/19/2007
• Issued: 01/15/2013
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Cai, Chad, Braido, Peter Nicholas, Allan, Bob, Ashworth, Paul Edward, Kruse, Steve
• Primary Examiner(s): Willse, David H
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US12/004,170
• Publication Number:
  US 20080147179A1
• Time in Patent Office: 1,854 Days
• Field of Search: 623/2.13, 623/2.38, 623/2.4, 623/2.42
• US Class Current: 623/2.14
• 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 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/3645 Connective tissue
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

A prosthetic heart valve includes an annular stent having annularly spaced commissure portions. The tips of the commissure portions are preferably covered with fabric, and then additional fabric covers that fabric and the remainder of the stent, both inside and out (possibly also including a sewing ring insert at or near the base or inflow edge). The fabric is then covered by a layer of tissue, again both inside and out. A single sheet of additional tissue is mounted around the outside of the previously assembled components. This additional tissue forms the leaflet portions of the valve. The leaflet portions of the additional tissue are shaped by contact with a shaped mandrel, and the tissue of the structure is subjected to fixation (e.g., cross-linking) to produce a completed valve.

Claims

1. A prosthetic heart valve comprising:

an annular stent having annularly spaced commissure portions, each commissure portion including a tip;

a first fabric cover over each tip, the first fabric cover not extending to the remainder of the annular stent;

a second fabric cover that extends over the first fabric cover and the remainder of the annular stent;

a first tissue membrane covering the first fabric cover and the second fabric cover; and

a second tissue membrane which surrounds the outside of the first tissue membrane, the first fabric cover and the second fabric cover;

wherein the second tissue membrane forms leaflet portions that extend inwardly between the commissure portions.

2. The prosthetic heart valve defined in claim 1 wherein the stent is made of metal.

3. The prosthetic heart valve defined in claim 1 wherein the first fabric cover comprises reemay fabric.

4. The prosthetic heart valve defined in claim 1 wherein the second fabric cover comprises polyester fabric.

5. The prosthetic heart valve defined in claim 1 wherein the first tissue membrane comprises porcine pericardium tissue.

6. The prosthetic heart valve defined in claim 1 wherein the second tissue membrane comprises bovine pericardium tissue.

7. The prosthetic heart valve defined in claim 1 further comprising:

a sewing cuff structure adjacent an edge of the valve that is axially opposite the commissure tips.

8. The prosthetic heart valve defined in claim 7 wherein the sewing cuff comprises a ring of filler material.

9. The prosthetic heart valve in claim 8 wherein the ring of filler material is disposed inside the second fabric cover.

10. The prosthetic heart valve defined in claim 9 wherein the ring of filler material comprises silicone.

11. The prosthetic heart valve defined in claim 1 wherein the second tissue membrane has been subjected to fixation after being assembled around the outside of the first tissue membrane, the first fabric cover and the second fabric cover.

12. The prosthetic heart valve defined in claim 11 wherein the second tissue membrane has been subjected to the fixation while the leaflet portions are shaped to extend inwardly between the commissure portions.

13. The prosthetic heart valve defined in claim 12 wherein the second tissue membrane has been subjected to the fixation while the leaflet portions are shaped, in contact with a shaping surface, to extend inwardly between the commissure portions.

14. The prosthetic heart valve of claim 1, wherein each commissure portion includes a first edge and a second edge, the first and second edges defining a space therebetween, the first fabric cover covering the space defined between the first and second edges.

15. A prosthetic heart valve comprising:

an annular stent having annularly spaced commissure portions, each commissure portion having a tip and a remaining commissure portion, each tip having an inside surface and an outside surface;

a first fabric cover substantially covering the inside and outside surfaces of each tip, but not covering each remaining commissure portion;

a second fabric cover that extends over the first fabric cover and the remainder of the annular stent;

a first tissue membrane covering the inside and outside of the first fabric cover and the second fabric cover; and

a second tissue membrane which surrounds the outside of the first tissue membrane, the first fabric cover and the second fabric cover;

wherein the second tissue membrane forms leaflet portions that extend inwardly between the commissure portions.

16. The prosthetic heart valve of claim 15, wherein each commissure portion includes a first edge and a second edge, the first and second edges defining a space therebetween, the first fabric cover covering the space defined between the first and second edges.