Biological tissue for surgical implantation

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.

We claim: 
     
         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 C 1 -C 3  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.