Biological tissue for surgical implantation

• US 9,918,832 B2
• Filed: 07/22/2011
• Issued: 03/20/2018
• Est. Priority Date: 10/27/2006
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Tian, Bin, Davidson, Jim
• Primary Examiner(s): Hobbs, Lisa J
• Application Number:
  US13/189,036
• Publication Number:
  US 20120012487A1
• Time in Patent Office: 2,433 Days
• Field of Search: 623 213
• 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 sealed package containing a sterilized bioprosthesis comprising:

a bioprosthetic heart valve comprising a pliable, elastic, and glutaraldehyde-fixed biological tissue having an interstitial volume comprising glycerol, wherein the biological tissue is coupled to a stent and wherein the bioprosthetic heart valve is treated with a solution comprising 50-90% glycerol and 50-10% ethanol; and

the sealed package containing the bioprosthetic heart valve, wherein the sealed package does not contain a liquid storage solution in contact with the bioprosthetic heart valve.

2. The sealed package of claim 1, wherein the biological tissue is selected from the group consisting of pericardium, aortic and pulmonary roots, tendons, ligaments, skin, facia, peritonium, pleura, and mitral and tricuspid valves.

3. The sealed package of claim 1, wherein the biological tissue is decellularized.

4. The sealed package of claim 1, wherein the stent is elastic and the bioprosthetic heart valve is collapsible.

5. The sealed package of claim 1, wherein the sealed package is sterilized by a gas or by exposure to ionizing radiation.

6. The sealed package of claim 5, wherein the gas is ethylene oxide.