BIOLOGICAL TISSUE FOR SURGICAL IMPLANTATION

• US 20130289695A1
• Filed: 06/27/2013
• Published: 10/31/2013
• Est. Priority Date: 10/27/2006
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tian, Bin, Davidson, James A.
• Application Number:
  US13/929,606
• Publication Number:
  US 20130289695A1
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A01N 1/0215 Disinfecting agents, e.g. antimicrobials for preserving living parts
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61L 2430/40 Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking
• 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 27/3687 characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
• 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 treating a biological tissue that enables dry storage of said tissue is disclosed. In one embodiment, the method comprises contacting the biological tissue with a non-aqueous treatment solution comprising a polyhydric alcohol and a C₁-C₃ alcohol and removing a portion of the treatment solution from the solution-treated biological tissue. Also disclosed is biological tissue prepared using the above process and prosthetic devices made with such tissue.

Claims

1. A method of manufacturing a bioprosthetic heart valve comprising:

providing a biological tissue and a stent;

contacting the biological tissue with a treatment solution comprising a polyhydric alcohol and an alcohol that is different from the polyhydric alcohol;

mounting the biological tissue to the stent to produce a bioprosthetic heart valve;

wherein the biological tissue remains pliable following the contacting; and

wherein the contacting is performed either before or after the mounting.

2. The method of claim 1, wherein the stent is elastic.

3. The method of claim 2, wherein the bioprosthetic heart valve is collapsible.

4. The method of claim 1, further comprising fixing the biological tissue prior to the contacting.

5. The method of claim 1, further comprising decellularizing the biological tissue prior to the contacting.

6. The method of claim 4, wherein the fixing is performed in the presence of glutaraldehyde.

7. The method of claim 1, wherein the polyhydric alcohol is one or a combination selected from the group consisting of:

glycerol, propylene glycol, a derivative of glycerol, and a derivative of propylene glycol.

8. The method of claim 1, wherein the polyhydric alcohol comprises one or a combination of a C₁-C₃ alcohol.

9. The method of claim 1, further comprising packaging the bioprosthetic heart valve in a container or package that does not contain a liquid storage solution in contact with the bioprosthetic heart valve.

10. The method of claim 9, further comprising applying a vacuum to the packaging and backfilling the packaging with an inert gas.

11. The method of claim 9, further comprising sterilizing the biological tissue by exposure to a gas or to ionizing radiation.

12. The method of claim 11, wherein the sterilizing is performed with ethylene oxide gas.

13. The method of claim 1, wherein the contacting is performed before the mounting.

14. The method of claim 1, wherein the contacting is performed after the mounting.