Biological tissue for surgical implantation

Patent metadata

Field	Value
Publication number	US-9918832-B2
Application number	US-201113189036-A
Country	US
Kind code	B2
Filing date	Jul 22, 2011
Priority date	Oct 27, 2006
Publication date	Mar 20, 2018
Grant date	Mar 20, 2018

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 C 1 -C 3 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.

First claim

We claim:

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.

Assignees

• Tian Bin
• Davidson Jim
• Edwards Lifesciences Corp

Inventors

• Tian Bin
• Davidson Jim

Classifications

• A61L2430/40

  Preparation and treatment of biological tissue for implantation, e.g. decellularisation, cross-linking · CPC title

• A61L27/3687

  characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents · CPC title

• A61F2/2415 Primary

  Manufacturing methods · CPC title

• A61L27/507

  for artificial blood vessels (apparatus for applying cells on a blood vessel prosthesis A61F2/062) · CPC title

• A61L27/3604 Primary

  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 title