Vascular graft sterilization and decellularization
View Patent ↗The present technology is related to the field of sterilization and decellularization of allografts or xenografts, specifically to processes that achieve effective removal of the cells contained within a vascular tissue matrix and an effective reduction in potential harmful organisms to create grafts suitable for human implantation. In some embodiments, vascular grafts, vascular tissue and/or blood vessels are contacted with cleaning solution under conditions suitable conditions to reduce immune reaction in patients. More specifically, the present technology is directed to sterilization and decellularization of vascular grafts.
1. A process for making a vascular graft more suitable for implantation into a recipient, the process comprising:
(a) contacting a vascular graft with an oxidizing sterilant; and
(b) contacting the vascular graft with a cleaning solution;
wherein during either step (a) or (b) or both,
a pressure gradient in the range of from about 100 mm Hg to about 400 mm Hg across a wall of said vascular graft is maintained by the flow of said cleaning solution or said oxidizing sterilant through said vascular graft;
wherein the contacting steps are at a temperature less than about 45° C. and for a total contact time less than about 8 hours; and
wherein the vascular graft comprises allograft or xenograft vascular tissue.
2. The process of claim 1 , wherein the steps are performed in the order (a), then (b).
3. The process of claim 1 , wherein a decellularized graft is produced.
4. The process of claim 1 , wherein the oxidizing sterilant is selected from the group consisting of peroxides, oxides, hypochlorites, ozone and percarboxylic acids; or mixtures thereof.
5. The process of claim 1 , wherein the oxidizing sterilant is a percarboxylic acid selected from the group consisting of peracetic acid, perpropionic acid, perbutyric acid, peroctanoic acid, perglycolic acid, perglutaric acid, persuccinic acid, perlactic acid, percitric acid and perdecanoic acid; or mixtures thereof.
6. The process of claim 1 , wherein the oxidizing sterilant is peracetic acid.
7. The process of claim 1 , wherein the cleaning solution is selected from the group consisting of solutions of cholate, alcohol ethoxylates, alkylphenol ethoxylates, alkyl polyglycosides, polyoxyethylene ethers, polyoxyethylene sorbitans, any of the Triton, Tween or Brij series of detergents, alkyl benzenesulfonates, alkyl sulfonates, alkyl phosphates, and alkyl sulfates; or salts or mixtures thereof.
8. The process of claim 1 , wherein the cleaning solution is a solution of cholate.
9. The process of claim 1 , wherein during either step (a) or (b) or both, the vascular graft is submerged in solution.
10. The process of claim 1 , wherein said pressure gradient results in mass transport by fluid convection and/or diffusion through said wall of said vascular graft.