Tissue Implants for Implantation and Methods for Preparing the Same
A method is provided for preparing a tissue implant for implantation. The method includes harvesting a tissue material from a human or an animal donor, treating the tissue material with water or a hypotonic solution to lyse native cells of the tissue material, treating the tissue material in a nuclease-containing solution which includes an antimicrobial, treating the tissue material with an alkaline alcohol solution, treating the tissue material with a chlorine dioxide treatment solution, and sterilizing the tissue material.
1 . A method of preparing a tissue implant for implantation comprising:
treating a tissue material in an alkaline alcohol solution;
treating the tissue material in a chlorine dioxide solution; and
irradiating the tissue material.
2 . The method of claim 1 , wherein the alkaline alcohol solution comprises ethanol.
3 . The method of claim 1 , wherein the ethanol is present in a concentration of about 72 to about 88 percent v/v.
4 . The method of claim 1 , wherein the alkaline alcohol solution comprises sodium hydroxide.
5 . The method of claim 4 , wherein the alkaline alcohol solution is about 0.016 M to about 0.022 M sodium hydroxide.
6 . The method of claim 1 , wherein during treatment with the chlorine dioxide treatment solution, the chlorine dioxide treatment solution comprises greater than about 50 ppm chlorine dioxide for about 60 minutes or longer.
7 . The method of claim 1 , wherein the concentration of chlorine dioxide in the chlorine dioxide treatment solution is about 100 ppm to about 160 ppm.
8 . The method of claim 1 , wherein the step of irradiating the tissue material comprises irradiating the tissue material with gamma radiation or electron beam radiation.
9 . A method of preparing a tissue implant for implantation comprising:
lysing a tissue material;
treating the tissue material in a nuclease-containing solution, the nuclease-containing solution comprising an antimicrobial;
treating the tissue material with an alkaline alcohol solution;
treating the tissue material with a chlorine dioxide treatment solution; and
sterilizing the tissue material.
10 . The method of claim 9 , wherein the step of sterilizing the tissue material comprises
treating the tissue material with an antioxidant; and
irradiating the tissue material.
11 . The method of claim 10 , further comprising vacuum sealing the tissue material in a package with the antioxidant.
12 . The method of claim 11 , further comprising washing the tissue material in an antibiotic-containing buffer solution after the tissue material is rendered essentially acellular.
13 . The method of claim 9 , wherein the tissue material comprises a sheet-like tissue material.
14 . The method of claim 13 , wherein the tissue material comprises human, bovine or equine pericardium.
15 . The method of claim 9 , wherein the antimicrobial comprises benzyl alcohol.
16 . The method of claim 15 , wherein the benzyl alcohol is present in the nuclease-containing solution in a concentration of about 0.8 to about 2.0% v/v.
17 . The method of claim 9 , wherein the nuclease-containing solution comprises DNase or RNase or a combination thereof.
18 . The method of claim 9 , wherein the alkaline alcohol solution comprises ethanol.
19 . The method of claim 18 , wherein the ethanol is present in a concentration of about 72 to about 88 percent v/v.
20 . The method of claim 9 , wherein the alkaline alcohol solution comprises a hydroxide salt.
21 . The method of claim 20 , wherein the hydroxide salt comprises sodium hydroxide.
22 . The method of claim 21 , wherein the alkaline alcohol solution is about 0.016 M to about 0.022 M sodium hydroxide.
23 . The method of claim 9 , wherein during treatment with the chlorine dioxide treatment solution, the chlorine dioxide treatment solution comprises greater than about 50 ppm chlorine dioxide for about 60 minutes or longer.
24 . The method of claim 9 , wherein the concentration of chlorine dioxide in the chlorine dioxide treatment solution is about 100 ppm to about 160 ppm.
25 . The method of claim 10 , wherein the antioxidant comprises ascorbic acid or a salt thereof.
26 . The method of claim 25 , wherein the antioxidant is sodium ascorbate.
27 . The method of claim 10 , wherein the antioxidant comprises a solution comprising sodium ascorbate in a concentration of about 9.0 mM to about 11.0 mM.
28 . The method of claim 10 , wherein the tissue material is irradiated with an electron beam.
29 . A method of preparing a tissue implant for implantation comprising:
harvesting a tissue material from a human or an animal donor;
treating the tissue material with water or a hypotonic solution to lyse native cells of the tissue material;
treating the tissue material in a nuclease-containing solution, the nuclease-containing solution comprising an antimicrobial;
treating the tissue material with an alkaline alcohol solution;
treating the tissue material with a chlorine dioxide treatment solution; and
sterilizing the tissue material.
30 . The method of claim 29 , wherein the step of sterilizing the tissue material comprises
treating the tissue material with an antioxidant; and
irradiating the tissue material.
31 . The method of claim 30 , further comprising vacuum sealing the tissue material in a package with the antioxidant.
32 . The method of claim 29 , wherein the tissue implant is prepared without treating the tissue with an antibiotic.
33 . The method of claim 29 , wherein the tissue material comprises a sheet-like tissue.
34 . The method of claim 33 , wherein the tissue material comprises human, bovine or equine pericardium.
35 . The method of claim 29 , wherein the antimicrobial comprises benzyl alcohol.
36 . The method of claim 35 , wherein the benzyl alcohol is present in the nuclease-containing solution in a concentration of about 0.8 to about 2.0% v/v.
37 . The method of claim 36 , wherein the nuclease-containing solution comprises DNase or RNase or a combination thereof.
38 . The method of claim 29 , wherein the alkaline alcohol solution comprises ethanol.
39 . The method of claim 38 , wherein the ethanol is present in a concentration of about 72 to about 88 percent v/v.
40 . The method of claim 29 , wherein the alkaline alcohol solution comprises sodium hydroxide.
41 . The method of claim 40 , wherein the alkaline alcohol solution is about 0.016 M to about 0.022 M sodium hydroxide.
42 . The method of claim 29 , wherein during treatment with the chlorine dioxide treatment solution, the chlorine dioxide treatment solution comprises greater than about 50 ppm chlorine dioxide for about 60 minutes or longer.
43 . The method of claim 29 , wherein the concentration of chlorine dioxide in the chlorine dioxide treatment solution is about 100 ppm to about 160 ppm.
44 . The method of claim 30 , wherein the antioxidant is ascorbic acid or a salt thereof.
45 . The method of claim 44 , wherein the antioxidant is sodium ascorbate.
46 . The method of claim 30 , wherein the antioxidant comprises a solution comprising sodium ascorbate in a concentration of about 9.0 mM to about 11.0 mM.
47 . The method of claim 30 , wherein the tissue material is irradiated with an electron beam.
48 . A tissue implant prepared by the method of claim 1 .
49 . A tissue implant prepared by the method of claim 9 .
49 . A tissue implant prepared by the method of claim 29 .