Vascular graft sterilization and decellularization
First Claim
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.
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Accused Products
Abstract
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.
35 Citations
10 Claims
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1. A process for making a vascular graft more suitable for implantation into a recipient, the process comprising:
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(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; andwherein the vascular graft comprises allograft or xenograft vascular tissue. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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Specification