Method for detoxifying a biological tissue

Abstract

Biological tissues may be prepared for use in biological prostheses. The biological tissue may be fixated with glutaraldehyde and may be subjected to successive treatment of the tissue with a solution containing taurine to neutralize excess aldehyde groups that remain free after fixation.

We claim: 
     
         1 . A method of treating a biological tissue for use in a biological prosthesis, the method comprising the steps:
 treating the biological tissue with a fixation solution comprising glutaraldehyde at a concentration within the range from 0.3% v/v to 1.0% v/v, in a buffer at a pH from 5 to 8; and   treating the biological tissue with a detoxification solution comprising taurine at a concentration within the range from 0.10% v/v to saturation in a buffer at a pH from 4 to 9, and at a temperature from 25° C. to 50° C.;   wherein treating the biological tissue with the detoxification solution at a temperature range from 25° C. to 50° C. reduces calcification of the biological tissue when compared to treating a biological tissue at 20° C.   
     
     
         2 . The method according to  claim 1 , wherein the detoxification solution comprises the taurine at a concentration within the range of 0.20% v/v to 1.00% v/v. 
     
     
         3 . The method according to  claim 1 , wherein the detoxification solution comprises the taurine at a concentration of about 0.70% v/v. 
     
     
         4 . The method according to  claim 1 , wherein the detoxification solution buffer is selected from a phosphate buffer, a citrate buffer, an acetate buffer, a HEPES buffer, or a borate buffer. 
     
     
         5 . The method according to  claim 1 , wherein the detoxification solution buffer is a phosphate buffer. 
     
     
         6 . The method according to  claim 1 , wherein the detoxification solution has a pH in the range of 5 to 8. 
     
     
         7 . The method according to  claim 1 , wherein the detoxification solution has a pH of about 7. 
     
     
         8 . The method according to  claim 1 , wherein treating the biological tissue with a detoxification solution is carried out at a temperature of 40° C. 
     
     
         9 . The method according to  claim 1 , wherein treating the biological tissue with a detoxification solution is carried out for a period of 12 to 48 hours. 
     
     
         10 . The method according to  claim 1 , wherein the fixation solution comprises the glutaraldehyde at a concentration of about 0.5% v/v. 
     
     
         11 . A method of treating a biological tissue for use in a biological prosthesis, the method comprising the steps:
 fixing the biological tissue with a solution comprising glutaraldehyde at a concentration within the range from 0.3% v/v to 1.0% v/v, in a buffer at a pH from 5 to 8; and   detoxifying the fixed biological tissue with a solution comprising taurine at a concentration within the range from 0.10% v/v to saturation in a buffer at a pH from 4 to 9, and at a temperature ranging from 20° C. to 50° C.   wherein treatment of the biological tissue with the detoxification solution reduces calcification of the biological tissue when compared to treatment of a biological tissue using a detoxification solution comprising homocysteic acid.   
     
     
         12 . The method according to  claim 11 , wherein the fixing solution comprises glutaraldehyde at a concentration of about 0.5% v/v. 
     
     
         13 . The method according to  claim 11 , wherein the detoxification solution comprises the taurine at a concentration within the range of 0.20% v/v to 1.00% v/v. 
     
     
         14 . The method according to  claim 11 , wherein the detoxification solution comprises the taurine at a concentration of about 0.70% v/v. 
     
     
         15 . The method according to  claim 11 , wherein the detoxification step is carried out at a temperature of 20° C. 
     
     
         16 . The method according to  claim 11 , wherein the detoxification step is carried out at a temperature of 40° C. 
     
     
         17 . The method according to  claim 11 , wherein the detoxification step is carried out at a temperature of 50° C. 
     
     
         18 . The method according to  claim 11 , wherein the detoxification solution has a pH of about 7.