Method for preparing biological tissues for use in biological prostheses

Abstract

A method of treating a biological tissue for biological prostheses includes steps of fixation of the biological tissue via a fixing solution including glutaraldehyde and detoxification of the fixed biological tissue via treatment with a detoxifying solution. The detoxification step includes one or both of eliminating phospholipids via treatment with an elimination solution and a treatment with a detoxifying solution. The elimination solution includes 1,2-octanediol and ethanol. The detoxifying solution includes taurine or homocysteic acid.

We claim: 
     
         1 . A method of treating a biological tissue for use in a biological prosthesis, the method comprising the steps:
 obtaining biological tissue;   treating the biological tissue using an elimination solution to eliminate phospholipids from the biological tissue, the elimination solution comprising 1,2-octanediol at a concentration range of 1% to 25% v/v and ethanol at a concentration range of 25% to 49% v/v; and   detoxifying the biological tissue using with a detoxifying solution at a temperature above room temperature, the detoxifying solution comprising taurine or homocysteic acid;   wherein treatment of the biological tissue to eliminate the phospholipids precedes detoxification of the biological tissue.   
     
     
         2 . The method according to  claim 1 , wherein detoxification occurs at a temperature above 30° C. 
     
     
         3 . The method according to  claim 1 , wherein detoxification occurs at a temperature of 35-45° C. 
     
     
         4 . The method according to  claim 1 , wherein detoxification occurs at a temperature of 40° C. 
     
     
         5 . The method according to  claim 1 , wherein the elimination solution includes 1,2-octanediol at a concentration expressed as v/v in the range of 2% to 10%. 
     
     
         6 . The method according to  claim 1 , wherein the elimination solution includes ethanol at a concentration expressed as v/v in the range of 30% to 45%. 
     
     
         7 . The method according to  claim 1 , wherein the elimination solution has a pH in the range of 4 to 9. 
     
     
         8 . The method according to  claim 1 , wherein treating the biological tissue using the elimination solution is carried out at a temperature between 15° C. and 65° C. 
     
     
         9 . The method according to  claim 1 , wherein treating the biological tissue using the elimination solution is carried out at a temperature between 30° C. and 40° C. 
     
     
         10 . The method according to  claim 1 , wherein treating the biological tissue using the elimination solution is carried out for a time period in the range of 2 to 7 days. 
     
     
         11 . The method according to  claim 1 , wherein treating the biological tissue using the elimination solution is carried out for a time period in the range of 16 to 72 hours. 
     
     
         12 . The method according to  claim 1 , wherein the detoxifying solution includes taurine at a concentration expressed as w/v in the range from 0.10% to saturation. 
     
     
         13 . The method according to  claim 1 , wherein the detoxifying solution includes taurine at a concentration expressed as w/v in the range of 0.20% to 1.00%. 
     
     
         14 . The method according to  claim 1 , wherein the detoxifying solution includes homocysteic acid at a concentration expressed as w/v in the range from 0.10% to saturation. 
     
     
         15 . The method according to  claim 1 , wherein the detoxifying solution has a pH in the of range 4 to 9. 
     
     
         16 . The method according to  claim 1 , wherein the detoxifying solution has a pH in the range of 5 to 8. 
     
     
         17 . The method according to  claim 1 , further comprising immersing the treated biological tissue in a fixing solution to facilitate tissue fixation, wherein the fixing solution contains glutaraldehyde. 
     
     
         18 . The method according to  claim 19 , wherein the fixing solution includes glutaraldehyde at a concentration expressed as v/v in the range of 0.10% to 2.00%. 
     
     
         19 . The method according to  claim 19 , wherein the fixing solution contains glutaraldehyde at a concentration expressed as v/v in the range of 0.30% to 1.00%. 
     
     
         20 . The method according to  claim 19 , wherein the fixing solution contains glutaraldehyde at a concentration of 0.5% v/v.