Claims for Patent: 6,652,818

Summary for Patent: 6,652,818

Title:	Implant sterilization apparatus
Abstract:	This invention includes a novel method for safely, effectively and efficiently pooling of tissues for treatment prior to implantation into a recipient in need thereof. In one embodiment, the method includes 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.
Inventor(s):	Mills; C. Randal (Alachua, FL), Wironen; John F. (Alachua, FL), Hanstke; Sean (Woodbridge, CA), Donda; Russell S. (Alachua, FL), Grooms; Jamie M. (Alachua, FL)
Assignee:	Regeneration Technologies, Inc. (Alachua, FL)
Application Number:	09/378,527
Patent Claims:	1. An apparatus for implant cleaning, perfusion, and passivation comprising: (i) a programmable logic controller to activate or deactivate valves or solenoids 301a-h at pre-determined times in the cleaning cycle such that an implant to be cleaned is exposed to cyclic increased and decreased pressures; (ii) a sealable reaction chamber 310 into which a tissue to be cleaned is placed; (iii) a chemical mixing tank 330 from which cleaning fluids are introduced into said sealable reaction chamber 310; (iv) a vacuum receiver tank 360, linkable to said reaction chamber 310 so that substantially instantaneous vacuum of pre-determined dimensions is optionally applied to the reaction chamber 310, without the need for a vacuum pump to gradually develop negative pressure in said reaction chamber 310; (v) a source of sterile water, or aqueous solution; and (vi) a pressure tank 380 which is pressurized by a compressor of filtered gas, to retain sterility in the reaction 310. 2. An apparatus for implant cleaning, perfusion, and passivation comprising: (i) a programmable logic controller to activate or deactivate one or more valves or solenoids at pre-determined times in the cleaning cycle such that an implant to be cleaned is alternately exposed to increased and decreased pressures; (ii) a sealable reaction chamber into which a tissue to be cleaned is placed; (iii) a chemical mixing tank from which cleaning fluids are introduced into said sealable reaction chamber; (iv) a vacuum receiver tank, linkable to said reaction chamber so that substantially instantaneous vacuum of pre-determined dimensions is optionally applied to the reaction chamber, without the need for a vacuum pump to gradually develop negative pressure in said reaction chamber; (v) a source of sterile water, or aqueous solution; and (vi) a pressure tank which is pressurized by a compressor of filtered gas, to retain sterility in the reaction.

Details for Patent 6,652,818

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2018-11-13