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

• US 9,510,944 B2
• Filed: 10/15/2015
• Issued: 12/06/2016
• 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 N., Allan, Bob, Ashworth, Paul E., Kruse, Steven D., LaChance, Lise
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Shipmon, Tiffany
• Application Number:
  US14/883,807
• Publication Number:
  US 20160030173A1
• Time in Patent Office: 418 Days
• US Class Current: 1/1
• 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 method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Claims

1. A prosthetic heart valve, comprising:

an annular stent having an inner side, an outer side, an inflow edge and an outflow edge, the inflow edge having a scalloped shape and the outflow edge including annularly spaced commissure portions, each commissure portion including a tip;

a first fabric cover over each tip, the first fabric cover not extending to a 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 that surrounds the first tissue membrane on the outer side of the stent, the first fabric cover and the second fabric cover.

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

3. The prosthetic heart valve as claimed in claim 1, wherein the stent is made of polymer.

4. The prosthetic heart valve as claimed in claim 1, wherein the first tissue membrane comprises mammalian pericardium.

5. The prosthetic heart valve as claimed in claim 1, wherein the second tissue membrane comprises mammalian pericardium.

6. The prosthetic heart valve as claimed in claim 1, further comprising a sewing cuff positioned adjacent the inflow edge of the stent.

7. The prosthetic heart valve as claimed in claim 6, wherein the sewing cuff has a scalloped shape corresponding to the scalloped shape of the inflow edge of the stent.

8. The prosthetic heart valve as claimed in claim 1, wherein the second tissue membrane forms leaflet portions that extend inwardly between the commissure portions.

9. A prosthetic heart valve, comprising:

an annular stent having an inner side, an outer side, an inflow edge and an outflow edge, the outflow edge including annularly spaced commissure portions, each commissure portion including a tip;

a sewing cuff positioned adjacent the inflow edge of the stent;

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

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

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

a second tissue membrane that surrounds the first tissue membrane on the outer side of the stent in a region between the sewing cuff and the outflow edge of the stent.

10. The prosthetic heart valve as claimed in claim 9, wherein the stent is made of metal.

11. The prosthetic heart valve as claimed in claim 9, wherein the stent is made of polymer.

12. The prosthetic heart valve as claimed in claim 9, wherein the first tissue membrane comprises mammalian pericardium.

13. The prosthetic heart valve as claimed in claim 9, wherein the second tissue membrane comprises mammalian pericardium.

14. The prosthetic heart valve as claimed in claim 9, wherein the sewing cuff includes a silicone ring.

15. The prosthetic heart valve as claimed in claim 9, wherein the second tissue membrane forms leaflet portions that extend inwardly between the commissure portions.

16. The prosthetic heart valve as claimed in claim 9, wherein the inflow edge has a scalloped shape and the sewing cuff has a scalloped shape corresponding to the scalloped shape of the inflow edge.

17. The prosthetic heart valve as claimed in claim 16, wherein the second tissue membrane has a first edge connected to the first tissue membrane, the first edge having a scalloped shape corresponding to the scalloped shape of the sewing cuff.