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

• US 9,192,470 B2
• Filed: 12/26/2012
• Issued: 11/24/2015
• Est. Priority Date: 12/19/2006
• Status: Active Grant

• Current Assignee: St. Jude Medical (Abbott Laboratories Incorporated)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories Incorporated)
• Inventors: Cai, Chad, Braido, Peter Nicholas, Allan, Bob, Ashworth, Paul Edward, Kruse, Steven D., LaChance, Lise
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): SHIPMON, TIFFANY P
• Application Number:
  US13/727,074
• Publication Number:
  US 20130184812A1
• Time in Patent Office: 1,063 Days
• Field of Search: 623/2.13, 623/2.38, 623/2.4, 623/2.42
• 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 method of making a prosthetic heart valve comprising:

providing an annular stent having a plurality of annularly spaced commissure portions, each commissure portion having a tip;

covering each of the tips with a first fabric cover, the first fabric cover not extending to a remainder of the annular stent;

covering the first fabric covers and the remainder of the annular stent with a second fabric cover;

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

covering the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

2. The method of claim 1, wherein the providing step includes cutting the stent from a tube using a laser.

3. The method of claim 1, further comprising:

fixating the second tissue membrane after covering the outside of the first tissue membrane with the second tissue membrane.

4. The method of claim 3, wherein the second tissue membrane is fixated by holding the leaflet portions inwardly between annularly adjacent ones of the commissure portions.

5. The method of claim 1, further comprising:

shaping the leaflet portions using a die.

6. The method of claim 1, further comprising:

exposing the second tissue membrane to a cross-linking agent.

7. The method of claim 1, further comprising:

forming a sewing cuff annularly around the stent and axially remote from the commissure tips.

8. A method of making a prosthetic heart valve comprising:

providing an annular stent having a plurality of annularly spaced commissure portions, each commissure portion having a tip;

covering each of the commissure tips with a fabric tip cover;

covering the tip covers and a remainder of the stent with an additional fabric cover;

covering the additional fabric cover with a tissue cover; and

mounting additional tissue around a radially outer surface of the tissue cover, the additional tissue including leaflet portions that extend inwardly between annularly adjacent ones of the commissure portions.

9. The method of claim 8, wherein the providing step includes cutting the stent from a tube using a laser.

10. The method of claim 8, further comprising:

subjecting the additional tissue to fixation after the mounting step.

11. The method of claim 10, wherein the subjecting step includes:

holding the leaflet portions inwardly between annularly adjacent ones of the commissure portions during the fixation.

12. The method of claim 11, wherein the holding step includes providing a shaping surface for shaping the leaflet potions during the fixation.

13. The method of claim 10, wherein the subjecting step includes exposing the additional tissue to a cross-linking agent.

14. The method of claim 10, further comprising:

forming a sewing cuff annularly around the stent and axially remote from the commissure tips.

15. The method of claim 14, wherein the sewing cuff comprises a ring of filler material.

16. A method of making a prosthetic heart valve comprising:

providing an annular stent having a plurality of annularly spaced commissure portions, a radially inner surface and a radially outer surface;

covering the radially inner surface and the radially outer surface of the stent with a fabric cover;

covering the radially inner surface and the radially outer surface of the fabric cover with a tissue cover; and

securing additional tissue around the radially outer surface of the tissue cover, the additional tissue including leaflet portions that extend inwardly between annularly adjacent ones of the commissure portions.

17. The method of claim 16, wherein the stent is made of metal.

18. The method of claim 16, wherein the fabric cover comprises polyester fabric.

19. The method of claim 16, wherein the tissue cover comprises bovine pericardium tissue.

20. The method of claim 16, wherein the additional tissue comprises bovine pericardium tissue.