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

• US 20080147179A1
• Filed: 12/19/2007
• Published: 06/19/2008
• 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: Braido, Peter Nicholas, Ashworth, Paul Edward, Kruse, Steve, LaChance, Lise, Cai, Chad, Allan, Bob
• Granted Patent: US 8,353,954 B2
• Time in Patent Office: Days
• US Class Current: 623/2.4
• 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 of which includes a tip;

a fabric cover over each of the tips;

additional fabric covering the fabric covers and the remainder of the stent;

tissue covering the additional fabric; and

additional tissue around the outside of the previously mentioned components and including leaflet portions that extend inwardly between annularly adjacent ones of 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 fabric cover comprises reemay fabric.

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

5. The prosthetic heart valve defined in claim 1 wherein the tissue covering the additional fabric comprises porcine pericardium tissue.

6. The prosthetic heart valve defined in claim 1 wherein the additional tissue 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 defined in claim 8 wherein the ring of filler material is disposed inside the additional fabric.

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 additional tissue has been subjected to fixation after being assembled around the outside of the previously mentioned components.

12. The prosthetic heart valve defined in claim 11 wherein the additional tissue has been subjected to the fixation while the leaflet portions are shaped to extend inwardly between the annularly adjacent ones of the commissure portions.

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

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

providing an annular stent having annularly spaced commissure portions, each of which has a tip;

covering each of the tips with a fabric tip cover;

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

covering the additional fabric cover with a tissue cover; and

mounting 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.

15. The method defined in claim 14 wherein the providing comprises:

using a laser to cut the stent from a tube.

16. The method defined in claim 14 further comprising:

subjecting the additional tissue to fixation after the mounting.

17. The method defined in claim 16 wherein the subjecting comprises:

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

18. The method defined in claim 17 wherein the holding comprises:

providing a shaping surface for shaping the leaflet portions during the fixation.

19. The method defined in claim 16 wherein the subjecting comprises:

exposing the additional tissue to a cross-linking agent.

20. The method defined in claim 14 further comprising:

forming a sewing cuff that extends annularly around the valve and that is axially remote from the commissure tips.

21. A prosthetic heart valve comprising:

an annular stent having annularly spaced commissure portions;

a fabric cover over the inside and outside of the stent;

tissue covering the inside and outside of the fabric cover; and

additional tissue around the outside of the previously mentioned components and including leaflet portions that extend inwardly between annularly adjacent ones of the commissure portions.

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

providing an annular stent having annularly spaced commissure portions;

covering the inside and outside of the stent with a fabric cover;

covering the inside and outside of the fabric cover with a tissue cover; and

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