Claims for Patent: 6,613,278

Summary for Patent: 6,613,278

Title:	Tissue pooling process
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), Bianchi; John (Alachua, FL)
Assignee:	Regeneration Technologies, Inc. (Alachua, FL)
Application Number:	09/390,174
Patent Claims:	1. An implant cleaning, perfusion and passivation process comprising: a. evacuating a chamber containing an implant; b. backfilling said chamber with a cleaning solution or a mixture of cleaning solutions; c. pressurizing said chamber; d. cycling between steps (a) and (c), for between about 1 to 150 cycles, maintaining a temperature of between about 35 to 40 degrees centigrade, with optional application of ultrasonic energy. 2. The process according to claim 1, wherein said implant is composed of at least one of the following: porous materials, metallic materials, ceramic materials, synthetic materials, allograft tissue, autograft tissue, or xenograft tissue. 3. The process according to claim 1, further comprising the step of: e. machining said implant to final dimensions if not previously so machined. 4. The process according to claim 3, further comprising the step of: f. repeating steps (a) through (d), wherein said cleaning solution of step (b) is the same or different as the cleaning solution in repeated step (b). 5. The process according to claim 4, wherein step (f) is conducted under elevated or reduced temperatures. 6. The process according to claim 5 further comprising placing said implant into a sterile, sealable package, and performing a surface decontamination step prior to or after sealing said package. 7. The process according to claim 1 wherein said implant is a tissue derived from a single donor. 8. The process according to claim 1, wherein said implant is a tissue derived from a pool of donor tissues. 9. The process according to claim 1 wherein said cleaning solution is selected from the group consisting of: sterile water, Triton X-100, TNBP, 3% hydrogen peroxide, a water-miscible alcohol, saline solution povidone iodine, ascorbic acid solution, aromatic or aliphatic hydrocarbons, ethers, ketones, amines, urea, guanidine hydrochloride, esters, glycoproteins, proteins, saccharides, enzymes, gasseous acids or peroxides, and mixtures thereof. 10. The process according to claim 7 wherein said tissue is pooled with similarly treated tissue from at least one other donor, and is further cleaned by conducting steps (a)-(d) using the same or different cleaning solutions. 11. The process according to claim 10 wherein said cleaning solution is selected from the group consisting of 6% hydrogen peroxide, 1% sodium hypochlorite, 6M urea, 4M guanidine hydrochloride, 1 N sodium hydroxide, isopropanol, water, saline and mixtures thereof. 12. The process according to claim 11 wherein said process is conducted at a temperature between about thirty-seven (37) degrees centigrade and about eighty (80) degrees centigrade. 13. The process according to claim 12 wherein said process is conducted at about 50-60 degrees centigrade. 14. The process according to claim 8 wherein said tissue is pooled with similarly treated tissue from at least one other donor, and is cleaned by conducting steps (a)-(D) using the same or different cleaning solutions. 15. The process according to claim 14 wherein said cleaning solution is selected from the group consisting of 6% hydrogen peroxide, 1% sodium hypochlorite, 6M urea, 4 M guanidine hydrochloride, 1 N sodium hydroxide, isopropanol, water, saline and mixtures thereof. 16. The process according to claim 15 wherein said process is conducted at a temperature between about thirty-seven (3 degrees centigrade and about eighty (80) degrees centigrade. 17. The process according to claim 16 wherein said process is conducted at about 50-60 degrees centigrade. 18. The process according to claim 1 wherein the cycling of pressures is conducted at pressures above one atmosphere, below one atmosphere, or both. 19. The process according to claim 18 wherein vacuum pressures of between about 60 to 100 torr and the vapor pressure of the solutions in contact with the implant and backfill pressures of between about 6-10 atmospheres are employed, and wherein concurrent sonication occurs throughout or at specific stages in said cycling of pressures. 20. A method for making an implant which comprises combining tissue or tissue and synthetic material treated according to the method of claim 1 form a composite implant. 21. The process according to claim 2, wherein said allograft tissue, autograft tissue, or xenograft tissue comprises of at least one of the following: cortical bone, cancellous bone, fasica, whole joints, tendons, ligaments, dura, pericardia heart valves, veins, neural tissue, submucosal tissue, or cartilage. 22. The process according to claim 4, further comprising the g. pooling the resultant product of step (d) or step (e), wherein said tissue is derived from a plurality of non-identical donors; and h. repeating steps (a) through (d), wherein, upon repeating of step (b), said cleaning solution of step (b) is the same or different.

Details for Patent 6,613,278

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