METHOD FOR PREPARING BIOLOGICAL TISSUES FOR USE IN BIOLOGICAL PROSTHESES
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.
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.