# US 2014/0155844 A1 · Antimicrobial barrier device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2014/0155844 A1 - Document ID: US20140155844A1 - Status: Published application - Kind: A1 - Application number: 14/094,182 - Filed: 2013-12-02 - Published: 2014-06-05 - Earliest claimed: 2012-12-05 - Assignees: Cook Medical Technologies LLC - Inventors: Andrew P. Isch; Steven J. Charlebois - Web page: https://patentgrep.com/patent/US20140155844A1 ## CPC - A61M 5/001: {Apparatus specially adapted for cleaning or sterilising syringes or needles} - A61L 31/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} - A61L 31/16: Biologically active materials, e.g. therapeutic substances {(A61L31/047 takes precedence)} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)} - A61M 39/18: Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking - A61L 2300/202: with halogen atoms, e.g. triclosan, povidone-iodine - A61L 2300/206: Biguanides, e.g. chlorohexidine - A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents - A61L 2300/406: Antibiotics - A61M 2025/0056: {provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir} - A61M 2025/0273: {having slits to place the pad around a catheter puncturing site} - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - 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 The invention relates to an antimicrobial barrier device and methods of manufacture. The antimicrobial barrier comprises one or more antimicrobial drugs that inhibit biofilm formation and bacterial and/or fungal growth. The antimicrobial barrier is suited for use with insertable devices (e.g., catheters) to reduce the incidence of infection at and around the insertion site. ## Claims ### Claim 1 An antimicrobial barrier device comprising: a soft durometer silicone body comprising one or more directly incorporated antimicrobial drugs selected from the group consisting of an antifungal agent and an antibacterial agent, the soft durometer silicone body being substantially resistant to microbial colonization thereon, and having a) a first surface adapted to conform to a treatment area; and b) a hole extending therethrough, the hole being adapted to receive and seal to an insertable medical device. ### Claim 2 (depends on 1) The antimicrobial barrier device of claim 1 wherein the soft durometer silicone body is about 10 A to about 80 A durometer silicone. ### Claim 3 (depends on 1) The antimicrobial barrier device of claim 1 wherein the soft durometer silicone body is about 10 A to about 50 A durometer silicone. ### Claim 4 (depends on 1) The antimicrobial barrier device of claim 1 wherein the soft durometer silicone body is about 50 A durometer silicone ### Claim 5 (depends on 1) The antimicrobial barrier device of claim 1 wherein the one or more directly incorporated antimicrobial drugs is selected from the group consisting of a rifamycin, rifampicin, nitrofurantoin, triclosan, trimethoprim, nalidixic acid, vancomycin, a tetracycline, doxycycline, minocycline, tetracycline, an aminoglycoside, amikacin, gentamicin, neomycin, tobramycin, a fluoroquinolone, ciprofloxacin, levofloxacin, trovafloxacin, gemifloxacin, gentian violet, flucytosine, an azole drug, fluconazole, miconazole, itraconazole, ketoconazole, clotrimazole, and chlorhexidine. ### Claim 6 (depends on 5) The antimicrobial barrier device of claim 5 wherein the one or more directly incorporated antimicrobial drugs is directly incorporated in a concentration of about 1 mg to about 30 mg per gram of soft durometer silicone body. ### Claim 7 (depends on 1) The antimicrobial barrier device of claim 1 wherein the one or more directly incorporated antimicrobial drugs is directly incorporated in a concentration in mg per gram of soft durometer silicone body, wherein the directly incorporated antimicrobial drugs and concentrations are: a) about 10 mg/g to about 20 mg/g ciprofloxacin; b) about 4 mg/g to about 20 mg/g levofloxacin; c) about 20 mg/g to about 30 mg/g minocycline; d) about 10 mg/g to about 20 mg/g triclosan; e) about 10 mg/g to about 20 mg/g trimethoprim; f) about 1 mg/g to about 6 mg/g fluconazole; g) about 1 mg/g to about 6 mg/g itraconazole; or h) about 1 mg/g to about 6 mg/g gentian violet. ### Claim 8 (depends on 1) The antimicrobial barrier device of claim 1 wherein the one or more directly incorporated antimicrobial drugs is one or more antibacterial drugs and one or more antifungal drugs, each directly incorporated in a concentration in mg per gram of soft durometer silicone body, wherein the antibacterial drugs and concentrations are: a) about 10 mg/g to about 20 mg/g ciprofloxacin; b) about 4 mg/g to about 20 mg/g levofloxacin; c) about 20 mg/g to about 30 mg/g minocycline; d) about 10 mg/g to about 20 mg/g triclosan; or e) about 10 mg/g to about 20 mg/g trimethoprim; and wherein the antifungal drugs and concentrations are f) about 1 mg/g to about 6 mg/g fluconazole; g) about 1 mg/g to about 6 mg/g itraconazole; or h) about 1 mg/g to about 6 mg/g gentian violet; ### Claim 9 (depends on 1) The antimicrobial barrier device of claim 1 further comprising an adhesive coated onto the first surface. ### Claim 10 (depends on 9) The antimicrobial barrier device of claim 9 further comprising a cover, the cover being removably attached to the adhesive. ### Claim 11 (depends on 7) The antimicrobial barrier device of claim 7, wherein the soft durometer silicone body elutes the one or more directly incorporated antimicrobial drugs when contacted with the treatment area. ### Claim 12 (depends on 1) The antimicrobial barrier device of claim 1, wherein the soft durometer silicone body comprises about 1 mg/g to about 30 mg/g of the one or more directly incorporated antimicrobial drugs, wherein the soft durometer silicone body: a) is about 50 A durometer silicone; b) elutes about 1% to about 15% of the one or more directly incorporated antimicrobial drugs after exposure to artificial urine for about 1-3 days, and c) inhibits at least about 80% biofilm formation thereon. ### Claim 13 (depends on 1) The antimicrobial barrier device of claim 1, wherein the soft durometer silicone body comprises about 1 mg/g to about 30 mg/g of the one or more directly incorporated antimicrobial drugs, wherein the soft durometer silicone body: a) is about 50 A durometer silicone; b) elutes about 1% to about 15% of the one or more directly incorporated antimicrobial drugs after exposure to artificial urine for about 1-3 days, and c) inhibits substantially all biofilm formation thereon. ### Claim 14 (depends on 1) The antimicrobial barrier device of claim 1 further comprising a slit. ### Claim 15 (depends on 1) The antimicrobial barrier device of claim 1 further comprising means for attaching the soft durometer silicone body to the treatment area. ### Claim 16 A kit comprising: an insertable medical device; and a soft durometer silicone body comprising one or more directly incorporated antimicrobial drugs selected from the group consisting of an antifungal agent and an antibacterial agent, the soft durometer silicone body being substantially resistant to microbial colonization thereon, and having a) a first surface adapted to conform to a treatment area; and b) a hole extending therethrough, the hole being adapted to receive and seal to an insertable medical device. ### Claim 17 (depends on 11) The kit of claim 11 wherein the insertable medical device is a catheter, a needle, an infusion device, a peripheral venous catheter, a peripheral venous catheter needle, an indwelling infusion needle, a butterfly needle, a subcutaneous access device, an insulin pump needle, a patient controlled analgesia pump needle, an arterial catheter, a central venous catheter, a dialysis catheter, a peritoneal dialysis catheter, a nephrostomy catheter, a percutaneous cystostomy catheter, an indwelling paracentesis or pleurocentesis catheter or drain, a percutaneous nephrostomy, a cystostomy tube, a spinal or epidural catheter or a sensor. ### Claim 18 A method of manufacturing an antimicrobial barrier by directly incorporating an antimicrobial drug into a soft durometer silicone body comprising the steps of: a) dissolving one or more antimicrobial drugs in one or more solvents to provide a dissolved one or more antimicrobial drugs; b) mixing the dissolved one or more antimicrobial drugs with a first silicone elastomer to provide a first silicone elastomer mixture; c) evaporation of the one or more solvents from the first silicone elastomer mixture to provide a second silicone elastomer mixture; d) mixing the second silicone elastomer mixture with a second silicone elastomer to provide a third silicone elastomer mixture; e) transferring the third silicone elastomer mixture to a mold; and f) curing the third silicone elastomer mixture in the mold. ### Claim 19 (depends on 18) The method of claim 18, wherein the first, second, and third silicone elastomer mixtures are homogeneous mixtures. ### Claim 20 (depends on 19) The method of claim 19, wherein the antimicrobial drug is selected from the group consisting of a rifamycin, rifampicin, nitrofurantoin, triclosan, trimethoprim, nalidixic acid, vancomycin, a tetracycline, doxycycline, minocycline, tetracycline, an aminoglycoside, amikacin, gentamicin, neomycin, tobramycin, a fluoroquinolone, ciprofloxacin, levofloxacin, trovafloxacin, gemifloxacin, gentian violet, flucytosine, an azole drug, fluconazole, miconazole, itraconazole, ketoconazole, clotrimazole, and chlorhexidine.