Cyclic implant perfusion cleaning and passivation process
AssigneeRegeneration Technologies, Inc.
InventorsC. Randal Mills, John F. Wironen
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AssigneeRegeneration Technologies, Inc.
InventorsC. Randal Mills, John F. Wironen
Estimating the term…
This invention is a novel method for perfusion of a porous implant which achieves efficient interpenetration of desired factors into and removal of undesirable factors from the pores of the implant, cleaning of the implant, efficient passivation of the implant (inactivation of pathogens, microorganisms, cells, viruses and the like and reduction in antigenicity thereof), and the novel implant produced by such treatment. The process presents a system wherein the rate of pressure cycling, the fact of pressure cycling, and the amplitude of pressure cycling, results in highly cleaned tissues and other implants for implantation. Target decontamination goals for this process include between about a one (1) to twelve (12) log reduction in bacterial contamination, between about a one (1) to fifteen (15) log reduction in enveloped virus contamination, up to about a five (5) log reduction in non-enveloped virus contamination, between about a two (2) to ten (10) fold reduction in endotoxin, maintenance of implant or graft biologic and biomechanical properties, absence of tissue toxicity due to cleaning solutions used, and reduced implant antigenicity.
An implant cleaning, perfusion and passivation process which comprises subjecting the entire implant to cyclic exposure of increased and decreased pressure above one atmosphere or below one atmosphere or both, wherein said implant consists essentially of autograft, allograft or xenograft tissue, or combinations thereof;
An implant cleaning, perfusion and passivation process which comprises subjecting the entire implant to cyclic exposure of increased and decreased pressure above one atmosphere or below one atmosphere or both, wherein said implant consists essentially of autograft, allograft or xenograft tissue, or combinations thereof;
An implant cleaning, perfusion and passivation process which comprises subjecting said implant to cyclic exposure of increased and decreased pressures above one atmosphere or below one atmosphere or both;
The process according to 31, wherein pressures below one atmosphere are between about 60 to 100 torr and pressures above one atmosphere are between about 6 to 10 atmospheres.
Dependencies are inferred from the claim text.