# US 5,707,366 A · Anti-infective and antithrombogenic medical articles and method for their preparation > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 5,707,366 A - Document ID: US5707366A - Status: Granted - Kind: A - Application number: 08/487,796 - Filed: 1995-06-07 - Granted: 1998-01-13 - Earliest claimed: 1989-01-18 - Assignees: Becton, Dickinson and Company - Inventors: Donald D. Solomon; M. Parke Byron - Web page: https://patentgrep.com/patent/US5707366A ## CPC - A61L 29/06: obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds - A61L 29/085: {Macromolecular materials} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61L 2300/104: Silver, e.g. silver sulfadiazine - A61L 2300/206: Biguanides, e.g. chlorohexidine - A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents - A61L 2300/406: Antibiotics - A61L 2300/45: Mixtures of two or more drugs, e.g. synergistic mixtures - 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} - 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) - 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)} ## Abstract An anti-infective medical article has chlorhexidine bulk distributed throughout a polyurethane base layer and may have a coating layer on the base layer. The coating layer may be chlorhexidine permeated into the surface or it may be an antibiotic, antithrombogenic agent or a polymeric surface layer laminated onto the base layer. The invention includes a method for preparing the article wherein a homogeneous melt of polymer and chlorhexidine is prepared by twin screw compounding and the melt is extruded to give a medical article having bulk distributed chlorhexidine. ## Claims ### Claim 1 A tubular medical article adapted for contacting with or inserting into living tissue, comprising a polymeric base layer having a water absorption of at least 0.6% by weight and a coating thereon, said base layer having a first increment of chlorhexidine bulk distributed throughout, and said coating including a second increment of chlorhexidine. ### Claim 2 (depends on 1) The article of claim 1 further including silver sulfadiazine. ### Claim 3 (depends on 2) The article of claim 2 wherein said silver sulfadiazine is on the exterior surface of said polymer. ### Claim 4 (depends on 2) The article of claim 2, wherein said silver sulfadiazine is on the interior surface of said article. ### Claim 5 (depends on 2) The article of claim 2, wherein said silver sulfadiazine is bulk distributed throughout said polymer. ### Claim 6 (depends on 1) The article of claim 1, wherein said coating further includes an antithrombogenic agent. ### Claim 7 (depends on 6) The article of claim 6, wherein said coating further includes an antibiotic. ### Claim 8 (depends on 1) The article of claim 1, wherein said coating further includes an antibiotic. ### Claim 9 (depends on 1) The article of claim 1 which is a catheter. ### Claim 10 A tubular medical article adapted for placement in contact with or insertion into living tissue, comprising a polymer having a water absorption of at least 0.6% by weight and an anti-infective agent comprising a biguanide bulk distributed throughout. ### Claim 11 (depends on 10) The article of claim 10, further comprising an antithrombogenic agent. ### Claim 12 (depends on 11) The article of claim 11, wherein said antithrombogenic agent is on a surface of said polymer. ### Claim 13 (depends on 12) The article of claim 12, wherein said antithrombogenic agent is on an interior surface of said article. ### Claim 14 (depends on 12) The article of claim 12, wherein said antithrombogenic agent is on an exterior surface of said article. ### Claim 15 (depends on 11) The article of claim 11, wherein said antithrombogenic agent is bulk distributed throughout said polymer. ### Claim 16 (depends on 10) The article of claim 10, wherein said biguanide is selected from the group consisting of a chlorhexidine base and a chlorhexidine salt. ### Claim 17 (depends on 16) The article of claim 16, wherein the concentration of said biguanide in said polymer is about 0.1 to 10% by weight. ### Claim 18 (depends on 17) The article of claim 17, wherein said polymer is a coating. ### Claim 19 (depends on 16) The article of claim 16, wherein said biguanide is a salt of chlorhexidine and said salt of chlorhexidine is selected from the group consisting of the hydrochloride, acetate and gluconate salts of chlorhexidine. ### Claim 20 (depends on 10) The medical article of claim 10, wherein said article further includes an antibiotic. ### Claim 21 (depends on 20) The article of claim 20, wherein said antibiotic is on a surface of said polymer. ### Claim 22 (depends on 20) The article of claim 20, wherein said antibiotic is on an interior surface of said article. ### Claim 23 (depends on 20) The article of claim 20, wherein said antibiotic is on an exterior surface of said article. ### Claim 24 (depends on 20) The article of claim 20, wherein said antibiotic is bulk distributed throughout said polymer. ### Claim 25 (depends on 10) The article of claim 10, wherein said polymer is selected from the group consisting of polyurethane, siloxane-urethane block copolymer and polyurethaneurea. ### Claim 26 (depends on 25) The article of claim 25, wherein said polymer is a coating. ### Claim 27 (depends on 10) The article of claim 10 which is a catheter. ### Claim 28 A tubular medical article for contacting with or inserting into living tissue, comprising a polymeric base layer having a water absorption of at least 0.6% by weight and a coating layer, the coating layer comprising a laminating polymer having a water absorption of at least 0.6% by weight, said base and laminating layers each having about 0.1 to 10% by weight of a biguanide bulk distributed throughout. ### Claim 29 (depends on 28) The article of claim 28, further including silver sulfadiazine. ### Claim 30 (depends on 29) The article of claim 29, wherein said silver sulfadiazine is on the exterior surface of said article. ### Claim 31 (depends on 29) The article of claim 29, wherein said silver sulfadiazine is on the interior surface of said article. ### Claim 32 (depends on 29) The article of claim 29, wherein said silver sulfadiazine is bulk distributed throughout said laminating polymer. ### Claim 33 (depends on 28) The medical article of claim 28, wherein said article further includes an antibiotic. ### Claim 34 (depends on 33) The article of claim 33, wherein said antibiotic is on a surface of said article. ### Claim 35 (depends on 33) The article of claim 33, wherein said antibiotic is on an interior surface of said article. ### Claim 36 (depends on 33) The article of claim 33, wherein said antibiotic is on an exterior surface of said article. ### Claim 37 (depends on 33) The article of claim 33, wherein said antibiotic is bulk distributed throughout said laminating polymer. ### Claim 38 (depends on 28) The article of claim 28, further comprising an antithrombogenic agent. ### Claim 39 (depends on 38) The article of claim 38, wherein said antithrombogenic agent is on a surface of said article. ### Claim 40 (depends on 38) The article of claim 38, wherein said antithrombogenic agent is on an interior surface of said article. ### Claim 41 (depends on 38) The article of claim 38, wherein said antithrombogenic agent is on an exterior surface of said article. ### Claim 42 (depends on 38) The article of claim 38, wherein said antithrombogenic agent is bulk distributed throughout said laminating polymer. ### Claim 43 (depends on 28) The article of claim 28, wherein said biguanide is selected from the group consisting of a chlorhexidine base and a chlorhexidine salt. ### Claim 44 (depends on 43) The article of claim 43, wherein said biguanide is a salt of chlorhexidine and said salt of chlorhexidine is selected from the group consisting of the hydrochloride, acetate and gluconate salts of chlorhexidine. ### Claim 45 (depends on 28) The article of claim 28, wherein said coating further comprises a second polymer having a water absorption of at least 0.6% by weight. ### Claim 46 (depends on 28) The article of claim 28, wherein said laminating polymer is selected from the group consisting of polyurethane, siloxane-urethane block copolymer and polyurethaneurea. ### Claim 47 (depends on 28) The article of claim 28 which is a catheter.