# US 2014/0193798 A1 · Cyclic implant perfusion, cleaning and passivation process and implant produced thereby > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0193798 A1 - Document ID: US20140193798A1 - Status: Published application - Kind: A1 - Application number: 14/203,925 - Filed: 2014-03-11 - Published: 2014-07-10 - Earliest claimed: 1998-11-13 - Assignees: RTI Surgical, Inc. - Applicants: RTI Surgical, Inc. - Inventors: C. Randal Mills; John F. Wironen; Sean Hanstke - Web page: https://patentgrep.com/patent/US20140193798A1 ## CPC - A01N 1/165: Pressure processes, e.g. following predefined pressure changes over time - A61L 2/025: Ultrasonic waves - A61L 2/18: Liquid substances - A61L 2103/05: Living organisms or biological materials - A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) ## Abstract 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. ## Claims ### Claim at position 1 1-35. (canceled) ### Claim 36 A method for producing a cleaned allograft or xenograft tissue implant by perfusion of cleaning solutions comprising: machine dimensioning an allograft or xenograft tissue implant to achieve final implant dimensions; placing said implant in a sealed vessel; and exposing said implant to three or more different cleaning solutions in series; wherein said three or more different cleaning solutions comprises, respectively: a) a detergent; b) a water-miscible alcohol; and c) hydrogen peroxide. ### Claim 37 (depends on 36) The method of claim 36, wherein the implant produced is suitable for implantation or processing for implantation in humans. ### Claim 38 (depends on 36) The method of claim 36, wherein said tissue comprises at least one of the following: cortical bone, cancellous bone, fascia, whole joint, tendon, ligament, dura, pericardia, heart valve, vein, neural tissue, submucosal tissue, cartilage, or combinations thereof. ### Claim 39 (depends on 38) The method of claim 38, wherein said tissue comprises at least one of the following: cortical bone or cancellous bone, or combinations thereof. ### Claim 40 (depends on 38) The method of claim 38, wherein said tissue comprises at least one of the following: fascia, whole joint, tendon, ligament, dura, pericardia, heart valve, vein, neural tissue, submucosal tissue, or cartilage, or combinations thereof. ### Claim 41 (depends on 36) The method of claim 36, wherein said implant is made from tissue derived from a single donor. ### Claim 42 (depends on 36) The method of claim 36, wherein said implant is made from tissue derived from a pool of donor tissues. ### Claim 43 (depends on 36) The method of claim 36, further comprising placing said cleaned tissue implant into a sterile, sealable package. ### Claim 44 (depends on 43) The method of claim 43, further comprising performing a surface decontamination step prior to or after sealing said package. ### Claim 45 (depends on 36) The method of claim 36, wherein the implant is perfused or coated with a bioactive substance. ### Claim 46 (depends on 45) The method of claim 45, wherein said bioactive substance is a drug or a growth factor. ### Claim 47 (depends on 46) The method of claim 46, wherein said growth factor is a bone morphogenetic protein, tissue growth factor beta or a member of the tissue growth factor beta family of growth factors, cartilage-derived morphogenetic proteins I or II or both, a cartilage derived growth factor, an angiogenic factor, or platelet derived growth factor. ### Claim 48 (depends on 36) The method of claim 36, further comprising maintaining the temperature between about 35-40 degrees centigrade during the exposing step.