Method of treating glutaraldehyde-fixed pericardial tissue with a non-aqueous mixture of glycerol and a C
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.
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 C 1 -C 3 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 C 1 -C 3 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 C 1 -C 3 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.