Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C1-C3 alcohol

• US 8,007,992 B2
• Filed: 10/23/2007
• Issued: 08/30/2011
• 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): SAUCIER, SANDRA E
• Application Number:
  US11/877,548
• Publication Number:
  US 20080102439A1
• Time in Patent Office: 1,407 Days
• Field of Search: None
• US Class Current: 435/1.1
• 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 treating a biological tissue, comprising:

contacting glutaraldehyde-fixed pericardial tissue with a non-aqueous treatment solution comprising a glycerol and a C₁-C₃ alcohol selected from the group consisting of methanol, ethanol, n-propanol, 2-propanol and mixtures thereof, wherein the glycerol is 60-95% by volume; and

removing a portion of the treatment solution from the solution-treated biological tissue to provide a biological tissue ready for sterilized containment.

2. The method of claim 1 wherein the glycerol is 70-80% by volume and the C₁-C₃ alcohol is 20-30% by volume.

3. The method of claim 2 wherein the treatment solution comprises 75% by volume of glycerol and 25% by volume of ethanol.

4. The method of claim 1 wherein the step of contacting the biological tissue with the treatment solution is performed for a time of greater than 30 minutes.

5. The method of claim 1 wherein the C₁-C₃ alcohol is ethanol.

6. The method of claim 1, wherein the pericardial tissue is bovine tissue.

7. The method of claim 6 wherein the tissue is selected from the group consisting of pericardium, aortic and pulmonary roots and valves, and tricuspid valves.

8. The method of claim 1 further comprising placing the biological tissue ready for sterilized containment in a package form, wherein the package form is pre-sterilized or sterilized following the placement of the tissue in the package form, and sealing the package form.

9. The method of claim 8, wherein the biological tissue is a heart valve prosthesis ready for surgical implantation.

10. The method of claim 9, wherein the heart value prosthesis contains a stent.

11. The method of claim 8, wherein the biological tissue is bovine pericardium.