Tissue implants for implantation and methods of preparing the same
View Patent ↗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 in a nuclease-containing solution, and thereafter treating the tissue material with an alkaline alcohol solution. The nuclease-containing solution includes an antimicrobial. The alkaline alcohol solution comprises sodium hydroxide and ethanol.
1. A method of preparing a tissue implant for implantation comprising:
treating a decellularized tissue material with an alkaline alcohol solution comprising an alkaline component in an amount from about 0.016 M to about 0.022 M,
wherein the tissue material comprises mammalian pericardium.
2. The method of claim 1 , wherein the alkaline alcohol solution comprises ethanol.
3. The method of claim 2 , 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 component comprises a hydroxide salt.
5. The method of claim 4 , wherein the hydroxide salt comprises sodium hydroxide.
6. The method of claim 5 , wherein the alkaline alcohol solution is about 0.020 M sodium hydroxide.
7. The method of claim 1 , wherein the alkaline alcohol solution comprises ethanol in a concentration from about 72 to about 88 percent v/v and about 0.016 M to about 0.022 M sodium hydroxide.
8. The method of claim 1 , wherein the decellularized tissue material is treated with the alkaline alcohol solution for about 60 minutes to about 3 hours.
9. The method of claim 1 , wherein the decellularized tissue material comprises human, bovine, porcine, or equine pericardium.
10. A method of preparing a tissue implant for implantation comprising:
treating a decellularized tissue material with an alkaline alcohol solution comprising an alkaline component in an amount from about 0.016 M to about 0.022 M; and thereafter
treating the decellularized tissue material with a chlorine dioxide solution.
11. The method of claim 10 , wherein the alkaline alcohol solution comprises ethanol.
12. The method of claim 11 , wherein the ethanol is present in a concentration of about 72 to about 88 percent v/v.
13. The method of claim 10 , wherein the alkaline component comprises sodium hydroxide.
14. The method of claim 13 , wherein the alkaline alcohol solution is about 0.02 M sodium hydroxide.
15. The method of claim 10 , wherein the alkaline alcohol solution comprises ethanol in a concentration from about 72 to about 88 percent v/v and about 0.016 M to about 0.022 M sodium hydroxide.
16. The method of claim 10 , wherein the decellularized tissue material is treated with the alkaline alcohol solution for about 60 minutes to about 3 hours.
17. The method of claim 10 , wherein during the 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.
18. A method of preparing a tissue implant for implantation comprising:
treating a decellularized tissue material with an alkaline alcohol solution comprising sodium hydroxide and ethanol, wherein the ethanol is present in the alkaline alcohol solution in a concentration from about 72 to about 88 percent v/v and the alkaline alcohol solution comprises about 0.016 M to about 0.022 M sodium hydroxide.
19. The method of claim 18 , wherein the decellularized tissue material comprises human, bovine, porcine, or equine pericardium.
20. A method of preparing a tissue implant for implantation comprising:
treating a decellularized tissue material with an alkaline alcohol solution comprising from about 0.016 M to about 0.022 sodium hydroxide and ethanol for about 60 minutes to about 3 hours; and thereafter
treating the decellularized tissue material with a chlorine dioxide solution comprising greater than about 50 ppm chlorine dioxide for about 60 minutes or longer;
wherein the decellularized tissue material comprises mammalian pericardium.