# US 2010/0163435 A1 · 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 2010/0163435 A1 - Document ID: US20100163435A1 - Status: Published application - Kind: A1 - Application number: 12/493,992 - Filed: 2009-06-29 - Published: 2010-07-01 - Earliest claimed: 2002-10-04 - Assignees: Ethicon, Inc. - Inventors: Jerry FISCHER; Howard SCALZO; Henry POKROPINSKI, JR. - Web page: https://patentgrep.com/patent/US20100163435A1 ## CPC - A61B 17/06114: {Packages or dispensers for needles or sutures (packages for sharps A61B50/3001; for dental floss A61C15/043; packages for needles in general B65D85/24)} - A61B 17/06138: {including a retainer comprising three or more foldable panels} - A61L 17/005: {containing a biologically active substance, e.g. a medicament or a biocide} - 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} - A61B 2050/314: {Flexible bags or pouches} - 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) ## Abstract A method of making a packaged antimicrobial suture having improved shelf life. The method comprising the steps of providing an inner package having a source of antimicrobial agent, providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time, positioning a suture within the inner package, the suture comprising one or more surfaces, covering the inner package with an outer package having an inner surface and subjecting the suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the suture and the inner package, thereby substantially inhibiting bacterial colonization on the suture and the inner package, wherein the packaged antimicrobial suture exhibits improved shelf life. A packaged antimicrobial suture and a method of increasing the shelf life of a packaged antimicrobial medical device are also provided. ## Claims ### Claim 1 A method of making a packaged antimicrobial suture having improved shelf life, the method comprising the steps of: providing an inner package having a source of antimicrobial agent; providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time; positioning a suture within the inner package, the suture comprising one or more surfaces; covering the inner package with an outer package having an inner surface; and subjecting the suture, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the suture and the inner package, thereby substantially inhibiting bacterial colonization on the suture and the inner package, wherein the packaged antimicrobial suture exhibits improved shelf life. ### Claim 2 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the adsorbent material is provided by coating the adsorbent material on at least a portion of one surface of the inner package. ### Claim 3 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the adsorbent material is provided by placing an adsorbent substrate within the outer package. ### Claim 4 (depends on 3) The method of making a packaged antimicrobial suture according to claim 3, wherein the adsorbent substrate is formed by coating a substrate with an adsorbent material. ### Claim 5 (depends on 3) The method of making a packaged antimicrobial suture according to claim 3, wherein the adsorbent substrate is formed of 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 thereof. ### 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 vapor 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 (depends on 1) The method of making a packaged antimicrobial suture according to claim 1, wherein the inner package comprises a universal envelope formed from a paperboard stock having at least one surface coated with an adsorbent material. ### Claim 13 (depends on 12) The method of making a packaged antimicrobial suture according to claim 12, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 14 (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 an one surface coated with an adsorbent material. ### Claim 15 (depends on 14) The method of making a packaged antimicrobial suture according to claim 14, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 16 A method of increasing the shelf life of a packaged antimicrobial medical device, the method comprising the steps of: providing an inner package having a source of antimicrobial agent; providing an adsorbent material effective to adsorb a portion of the antimicrobial agent over time; positioning a medical device within the inner package, the medical device comprising one or more surfaces; covering the inner package with an outer package having an inner surface; and subjecting the medical device, the inner package and the inner surface of the outer package to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of the antimicrobial agent from the antimicrobial agent source to the medical device and the inner package, thereby substantially inhibiting bacterial colonization on the medical device and the inner package, wherein the packaged antimicrobial medical device exhibits improved shelf life. ### Claim 17 (depends on 16) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the adsorbent material is provided by coating the adsorbent material on at least a portion of an one surface of the inner package. ### Claim 18 (depends on 16) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the adsorbent material is provided by placing an adsorbent substrate within the outer package. ### Claim 19 (depends on 18) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 18, wherein the adsorbent substrate is formed by coating a substrate with an adsorbent material. ### Claim 20 (depends on 18) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 18, wherein the adsorbent substrate is formed of an adsorbent material. ### Claim 21 (depends on 16) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the inner package comprises a universal envelope formed from a paperboard stock having at least one surface coated with an adsorbent material. ### Claim 22 (depends on 21) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 21, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 23 (depends on 16) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 16, wherein the inner package comprises a containment compartment and an outer cover, the outer cover having an one surface coated with an adsorbent material. ### Claim 24 (depends on 23) The method of increasing the shelf life of a packaged antimicrobial medical device according to claim 23, wherein the adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 25 A packaged antimicrobial suture having improved shelf life comprising: an inner package having a source of antimicrobial agent; an adsorbent material effective to adsorb a portion of said antimicrobial agent over time; a suture positioned within said inner package, said 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 suture, said inner package and said inner surface of said outer package are subjected to time, temperature and pressure conditions sufficient to vapor transfer an effective amount of said antimicrobial agent from said antimicrobial agent source to said suture and said inner package, thereby substantially inhibiting bacterial colonization on said suture and said inner package. ### Claim 26 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said packaged antimicrobial suture exhibits improved shelf life. ### Claim 27 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said adsorbent material is provided by coating said adsorbent material on at least a portion of one surface of said inner package. ### Claim 28 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said adsorbent material is provided by placing an adsorbent substrate within said outer package. ### Claim 29 (depends on 28) The packaged antimicrobial suture of claim 28, wherein said adsorbent substrate is formed by coating a substrate with an adsorbent material. ### Claim 30 (depends on 28) The packaged antimicrobial suture of claim 28, wherein said adsorbent substrate is formed of an adsorbent material. ### Claim 31 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said antimicrobial agent is selected from said group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof. ### Claim 32 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said inner package comprises a universal envelope formed from a paperboard stock having one surface coated with an adsorbent material. ### Claim 33 (depends on 32) The packaged antimicrobial suture of claim 32, wherein said adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 34 (depends on 25) The packaged antimicrobial suture of claim 25, wherein said inner package comprises a containment compartment and an outer cover, said outer cover having one surface coated with an adsorbent material. ### Claim 35 (depends on 34) The packaged antimicrobial suture of claim 34, wherein said adsorbent material is selected from bentonite, activated carbon, activated alumina, silica gel, zeolite, super-absorbant polymers, humectants, polymeric coatings, ground polymeric coatings, natural products, non-paper substrates, and clays, including kaolin. ### Claim 36 A packaged medical device comprising: an inner package having a source of antimicrobial agent; an adsorbent material effective to adsorb a portion of said antimicrobial agent over time; 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 vapor 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.