BIOLOGICAL VALVE FOR VENOUS VALVE INSUFFICIENCY

• US 20100234939A1
• Filed: 05/27/2010
• Published: 09/16/2010
• Est. Priority Date: 10/17/2007
• Status: Abandoned Application

• Current Assignee: Hancock Jaffe Laboratories, Inc.
• Original Assignee: Hancock Jaffe Laboratories, Inc.
• Inventors: Jaffe, Norman
• Application Number:
  US12/789,176
• Publication Number:
  US 20100234939A1
• Time in Patent Office: Days
• US Class Current: 623/1.240
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61L 27/3625 Vascular tissue, e.g. heart valves
• CPC Class Codes: A61L 27/507 for artificial blood vessels apparatus for applying cells on a blood vessel prosthesis A61F2/062

Abstract

A bioprosthetic valve for repairing a deep venous insufficiency in a subject includes a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of valve wall tissue. The patch may extend axially above and below the leaflet and circumferentially on either side of the leaflet to provide a region for attaching the patch to a fenestration in a host vein. A bioprosthetic valve may be manufactured by excising a portion of a xenogeneic heart valve including a single leaflet and contiguous wall tissue, and may further comprise shaving off excess leaflet tissue from adjacent leaflets. A method of replacing a malfunctioning venous valve in a subject includes providing a bioprosthetic valve as described above and inserting it to the host vein.

Claims

1. A method of treating a malfunctioning valve in a host vein of a subject, the method comprising:

providing a replacement biological valve comprising a single leaflet from a xenogeneic heart valve attached at natural margins of attachment to a patch of contiguous tissue from the xenogeneic heart valve; and

inserting said replacement biological valve into said host vein.

2. The method of claim 1, further comprising creating a fenestration in the host vein in the region of the malfunctioning valve, the fenestration having a shape generally corresponding to the patch.

3. The method of claim 2, wherein the fenestration is created generally in the region of the malfunctioning valve.

4. The method of claim 2, wherein the fenestration is created generally above the region of the malfunctioning valve.

5. The method of claim 2, wherein the fenestration is created generally below the region of the malfunctioning valve.

6. The method of claim 2, further comprising attaching the replacement biological valve to the host vein at the fenestration.

7. The method of claim 1, further comprising removing at least one leaflet from the malfunctioning valve of the host vein.

8. The method of claim 1, wherein the xenogeneic heart valve is a porcine aortic valve.

9. The method of claim 8, wherein the single leaflet is a noncoronary leaflet.

10. The method of claim 1, wherein the leaflet and patch have been subjected to a fixation treatment.

11. The method of claim 10, wherein the fixation treatment includes exposing the leaflet and patch to glutaraldehyde solution.

12. The method of claim 1, wherein the subject is human.

13. A method of manufacturing a replacement venous valve for a host vein in a subject, the method comprising:

obtaining a xenogeneic heart valve, the heart valve having at least one leaflet and a valve wall, the heart valve having been subjected to a fixation treatment;

excising a portion of the heart valve, the portion comprising at least a selected leaflet attached at natural margins of attachment to a patch of valve wall tissue, such that said excised portion comprises a single leaflet; and

configuring the patch such that the patch is suitable for attachment to said host vein.

14. The method of claim 13, wherein the xenogeneic heart valve is porcine.

15. The method of claim 13, wherein the patch extends circumferentially on either side of the selected leaflet to provide a region for attachment to the host vein.

16. The method of claim 13, wherein the patch extends axially above and below the selected leaflet to provide a region for attachment to the host vein.

17. The method of claim 13, wherein the xenogeneic heart valve is an aortic valve.

18. The method of claim 17, wherein the selected leaflet is a noncoronary leaflet.

19. The method of claim 13, further comprising cutting through each natural commissure of the selected leaflet and shaving off tissue of any leaflets adjacent to the selected leaflet.

20. The method of claim 13, wherein the subject is human.