# US 10,245,025 B2 · Packaged antimicrobial medical device having improved shelf life and method of preparing same > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,245,025 B2 - Document ID: US10245025B2 - Status: Granted - Kind: B2 - Application number: 13/727,340 - Filed: 2012-12-26 - Published: 2013-10-10 - Granted: 2019-04-02 - Earliest claimed: 2012-04-06 - Assignees: Ethicon, Inc. - Applicants: Ethicon, LLC - Inventors: Michael David Prikril; Howard L. Scalzo, Jr.; Leon Gisin - Web page: https://patentgrep.com/patent/US10245025B2 ## CPC - A61B 17/06133: {of parallelepipedal shape, e.g. made of rectangular or slightly oval panels} - A61L 17/005: {containing a biologically active substance, e.g. a medicament or a biocide} - B65B 55/18: by liquids or gases (B65B55/14 takes precedence) - A61B 17/06166: {Sutures (suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M)} - A61B 2017/00526: {Methods of manufacturing} - A61B 2017/00889: {antimicrobial, disinfectant} - A61B 2017/06142: {having needle- or suture- retaining members, e.g. holding tabs or needle parks} - A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents - A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D) - 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) - B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00) ## Abstract A packaged antimicrobial suture. The packaged antimicrobial suture includes an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial material reservoirs; at least one suture positioned within the inner package, the at least one suture comprising one or more surfaces; and an outer package having an inner surface, the outer package having the inner package positioned within; wherein the at least one suture, the inner package and the inner surface of the outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package. A method of making a packaged antimicrobial suture having is also provided. ## Claims ### Claim 1 A method of making a packaged antimicrobial suture, the method comprising the steps of: providing an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs; positioning at least one suture within the inner package, the at least one suture comprising one or more surfaces; covering the inner package with an outer package having an inner surface; and subjecting the at least one suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the at least one suture and the inner package, thereby substantially inhibiting bacterial colonization on the at least one suture and the inner package, wherein said antimicrobial agent reservoirs are formed of a non-woven polymeric fabric. ### Claim 2 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the inner package comprises a containment compartment and an outer cover, the outer cover having one surface coated with an adsorbent material. ### Claim 3 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the plurality of patches are positioned about an outer periphery of an inner surface of the outer cover. ### Claim 4 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, further comprising the step of providing an adsorbent or absorbent material. ### Claim 5 (depends on 4) The method of making a packaged antimicrobial suture according to claim 4, wherein the adsorbent or absorbent material is formed by coating a substrate with an adsorbent material. ### Claim 6 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the suture positioned within the inner package is substantially free of antimicrobial agent. ### Claim 7 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the suture positioned within the inner package is coated with antimicrobial agent. ### Claim 8 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations of halogenated hydroxyl ethers and acyloxydiphenyl ethers. ### Claim 9 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the effective amount of the antimicrobial agent transferred from the source of antimicrobial agent to the suture and the inner package is transferred during an ethylene oxide sterilization process. ### Claim 10 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the step of subjecting the suture, the inner package and the inner surface of the outer package to conditions sufficient to transfer an effective amount of the antimicrobial agent comprises the steps of: placing the outer package having the inner package and the suture therein in a sterilization unit; heating the sterilization unit to a first temperature; adjusting the pressure in the sterilization unit to a first pressure value; injecting steam into the sterilization unit to expose the inner surface of the outer package, the inner package and the suture to water vapor for a first period of time; adjusting the pressure within the sterilization unit to a second pressure value; introducing a chemical sterilization agent into the sterilization unit; maintaining the chemical sterilization agent in the sterilization unit for a second period of time to render a sufficient amount of microorganisms non-viable; removing residual moisture and chemical sterilization agent from the suture; and drying the packaged antimicrobial suture to a desired moisture level. ### Claim 11 (depends on 10) The method of making a packaged antimicrobial suture according to claim 10, wherein the step of introducing a chemical sterilization agent comprises introducing ethylene oxide gas into the sterilization unit. ### Claim 12 A packaged antimicrobial suture comprising: an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs; at least one suture positioned within said inner package, said at least one suture comprising one or more surfaces; and an outer package having an inner surface, said outer package having said inner package positioned within; wherein said at least one suture, said inner package and said inner surface of said outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of said antimicrobial agent from said antimicrobial agent source to said at least one suture and said inner package, thereby substantially inhibiting bacterial colonization on said at least one suture and said inner package, and wherein said antimicrobial agent reservoirs are formed of a non-woven polymeric fabric. ### Claim 13 (depends on 12) The packaged antimicrobial suture according to claim 12, wherein said inner package comprises a containment compartment and an outer cover. ### Claim 14 (depends on 13) The packaged antimicrobial suture according to claim 13, wherein said plurality of patches are positioned about an outer periphery of an inner surface of said outer cover. ### Claim 15 (depends on 12) The packaged antimicrobial suture according to claim 12, further comprising a coating of an adsorbent or absorbent material. ### Claim 16 (depends on 12) The packaged antimicrobial suture of claim 12, wherein said antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations of halogenated hydroxyl ethers and acyloxydiphenyl ethers. ### Claim 17 A packaged medical device comprising: an inner package having a source of antimicrobial agent, the source of antimicrobial agent comprising a plurality of patches, each patch having a pair of antimicrobial agent reservoirs; a medical device positioned within said inner package, said medical device comprising one or more surfaces; and an outer package having an inner surface, said outer package having said inner package positioned within; wherein said medical device, said inner package and said inner surface of said outer package are subjected to time, temperature and pressure conditions sufficient to transfer an effective amount of said antimicrobial agent from said antimicrobial agent source to said medical device and said inner package, thereby substantially inhibiting bacterial colonization on said medical device and said inner package, and wherein said antimicrobial agent reservoirs are formed of a non-woven polymeric fabric. ### Claim 18 (depends on 17) The packaged medical device according to claim 17, wherein said inner package comprises a containment compartment and an outer cover. ### Claim 19 (depends on 18) The packaged medical device according to claim 18, wherein said plurality of patches are positioned about an outer periphery of an inner surface of said outer cover. ### Claim 20 (depends on 17) The packaged medical device of claim 17, wherein said antimicrobial agent is selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations of halogenated hydroxyl ethers and acyloxydiphenyl ethers. ### Claim 21 (depends on 17) The packaged medical device according to claim 17, further comprising a coating of an adsorbent or absorbent material. ### Claim 22 (depends on 12) The packaged antimicrobial suture according to claim 12, wherein the non-woven polymeric fabric is comprised of high density polyethylene fibers. ### Claim 23 (depends on 17) The packaged medical device according to claim 17, wherein the non-woven polymeric fabric is comprised of high density polyethylene fibers.