# US 9,750,927 B2 · Blood control catheter with antimicrobial needle lube > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 9,750,927 B2 - Document ID: US9750927B2 - Status: Granted - Kind: B2 - Application number: 15/341,944 - Filed: 2016-11-02 - Published: 2017-03-02 - Granted: 2017-09-05 - Earliest claimed: 2013-03-11 - Assignees: Becton, Dickinson and Company - Applicants: Becton, Dickinson and Company - Inventors: Yiping Ma - Web page: https://patentgrep.com/patent/US9750927B2 ## CPC - A61M 39/10: Tube connectors or tube couplings - A61B 17/3421: {Cannulas} - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)} - A61M 25/002: {Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30)} - A61M 25/0043: {characterised by structural features} - A61M 25/0097: {characterised by the hub (tube connectors or tube couplings A61M39/10)} - A61M 25/0606: {"Over-the-needle" catheter assemblies, e.g. I.V. catheters} - A61M 25/065: {Guide needles} - A61M 39/0606: {without means for adjusting the seal opening or pressure (A61M39/0693 takes precedence)} - A61M 39/16: having provision for disinfection or sterilisation {(A61M39/143 takes precedence)} - A61M 39/162: {with antiseptic agent incorporated within the connector} - A61B 2017/00889: {antimicrobial, disinfectant} - A61B 2017/3437: {with means for removing or absorbing fluid, e.g. wicks or absorbent pads} - A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents - A61L 2400/10: Materials for lubricating medical devices - A61L 2420/02: Methods for coating medical devices - A61M 25/0045: {multi-layered, e.g. coated (coating materials A61L29/08)} - A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement} - A61M 2025/0046: {Coatings for improving slidability} - 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 2025/0062: {having features to improve the sliding of one part within another by using lubricants or surfaces with low friction} - A61M 2039/0036: {characterised by a septum having particular features, e.g. having venting channels or being made from antimicrobial or self-lubricating elastomer} - A61M 2039/062: {used with a catheter} - A61M 2039/064: {Slit-valve} - A61M 2039/068: {having a seal being made of or coated with a special material} - A61M 2039/1077: {Adapters, e.g. couplings adapting a connector to one or several other connectors} - A61M 2205/0205: Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent - A61M 2205/0222: Materials for reducing friction - 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)} - 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 An antimicrobial lubricant applied to an outer surface of an introducer needle as part of a catheter assembly device. The catheter assembly device further includes a septum having a slit through which the introducer needle is threaded. The antimicrobial lubricant is squeegeed, or removed from the outer surface of the introducer needle as the needle is removed from the slit following catheterization. The removed antimicrobial lubricant forms a deposit on the septum at a location proximate to the slit, thereby preventing colonization and growth of pathogens on the septum and other adjacent components and surfaces of the catheter assembly device. ## Claims ### Claim 1 A catheter assembly, comprising: a catheter adapter, wherein the catheter adapter comprises a proximal end, a distal end, a lumen extending therebetween, a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to a septum, and a catheter; wherein a proximal end of the catheter is coupled to the distal end of the catheter adapter; the septum disposed in the lumen of the catheter adapter, wherein the septum prevents fluid in the fluid pathway from exiting the proximal end of the catheter adapter; a needle comprising a base, a tip, and a body extending therebetween, wherein the body of the needle is disposed within the lumen of the catheter adapter; and an antimicrobial lubricant applied to only a portion of an outer surface of the needle, wherein the portion of the outer surface extends from a distal portion of the needle to a distal end of the septum when the needle extends beyond the distal end of the catheter, wherein as the needle is withdrawn proximally through the septum, the septum removes the antimicrobial lubricant from the needle thereby depositing the antimicrobial lubricant on the distal end of the septum. ### Claim 2 (depends on 1) The catheter assembly of claim 1, wherein the antimicrobial lubricant comprises at least one of a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, and a solid lubricant. ### Claim 3 (depends on 1) The catheter assembly of claim 1, wherein the antimicrobial lubricant comprises an oil lubricant such as polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. ### Claim 4 (depends on 1) The catheter assembly of claim 1, wherein the antimicrobial lubricant comprises an antimicrobial agent. ### Claim 5 (depends on 4) The catheter assembly of claim 4, wherein the antimicrobial agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, and benzalkonium chloride. ### Claim 6 (depends on 4) The catheter assembly of claim 4, wherein the antimicrobial lubricant further comprises at least one of a fugitive solvent component, an alcohol component, and an antimicrobial agent. ### Claim 7 (depends on 4) The catheter assembly of claim 4, wherein the antimicrobial agent is a non-alcohol based antimicrobial agent. ### Claim 8 (depends on 6) The catheter assembly of claim 6, wherein the polymer component is insoluble in water. ### Claim 9 (depends on 6) The catheter assembly of claim 6, wherein the polymer component is water soluble. ### Claim 10 (depends on 6) The catheter assembly of claim 6, wherein the antimicrobial agent is present in an amount from approximately 0.001% (w/v) to approximately 10.0% (w/v). ### Claim 11 (depends on 6) The catheter assembly of claim 6, wherein the antimicrobial agent is at least one of chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, and benzalkonium chloride. ### Claim 12 (depends on 6) The catheter assembly of claim 6, wherein the alcohol component comprises a lower alcohol having between one and six carbon atoms. ### Claim 13 (depends on 6) The catheter assembly of claim 6, wherein the alcohol component is present within the antimicrobial lubricant in amount approximately equal to 20% (w/v). ### Claim 14 (depends on 6) The catheter assembly of claim 6, wherein the alcohol component comprises a mixture of isopropyl alcohol and ethanol, and is present within the antimicrobial lubricant in an amount from approximately 40% (w/v) to approximately 95% (w/v). ### Claim 15 (depends on 6) The catheter assembly of claim 6, wherein the fugitive solvent comprises an organic solvent that is present within the antimicrobial lubricant in an amount from approximately 20% (w/v) to approximately 95% (w/v). ### Claim 16 A method for applying an antimicrobial lubricant to a septum of a catheter assembly, the method comprising: providing a catheter assembly, the catheter assembly comprising: a catheter adapter comprising a proximal end, a distal end, and a lumen extending therebetween, wherein the distal end of the catheter adapter comprises a distal opening; a catheter connected to the distal end of the catheter adapter, wherein the catheter comprises a distal end and a proximal end; and a septum disposed within the lumen; applying an antimicrobial lubricant to a portion of an outer surface of a needle, wherein the needle comprises a base, tip, and a body extending therebetween; preparing the catheter assembly for insertion into vasculature of the patient by inserting the needle proximally through the distal opening of the catheter adapter such that the body of the needle extends through the septum, the tip of the needle extends beyond the distal end of the catheter, and the portion is disposed distal to a distal end of the septum, wherein when the body of the needle extends through the septum, a slit of the septum seals around the body of the needle such that upon withdrawing the needle proximally from the slit of the septum, the slit removes a portion of the antimicrobial lubricant from the portion of the outer surface of the needle to form a deposit of the antimicrobial lubricant on the septum at a location proximate to the slit. ### Claim 17 (depends on 16) The method of claim 16, wherein a fluid pathway extending through the catheter adapter does not extend through the septum. ### Claim 18 (depends on 16) The method of claim 16, wherein the septum is configured to prevent fluid from exiting a proximal end of the catheter adapter, wherein the catheter adapter further comprises a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway that does not extend through the septum, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to the septum, and the catheter. ### Claim 19 A method of depositing an antimicrobial agent on a septum of a catheter adapter after insertion of a catheter into vasculature of a patient, the method comprising: applying an antimicrobial lubricant to an outer surface of a needle, wherein the needle comprises a base, a tip, and a body extending therebetween; preparing a catheter assembly for insertion into vasculature of a patient, wherein the catheter assembly comprises a catheter adapter having a lumen extending therethrough, a catheter connected to the catheter adapter, and septum disposed in the lumen, wherein preparing the catheter assembly for insertion into the vasculature comprises inserting the needle proximally through the distal opening of the catheter adapter such that the lubricant is not removed from the needle during insertion through the distal opening; inserting the needle and the catheter positioned around the needle into the vasculature of the patient; and withdrawing the needle from the catheter such that, as the needle passes through a slit in the septum, the slit removes the antimicrobial lubricant from the needle thereby forming a deposit of the antimicrobial lubricant around the slit of the septum. ### Claim 20 (depends on 19) The method of claim 19, wherein the catheter adapter comprises a side port connected to an extension tube, wherein a proximal end of the extension tube is configured to be connected to a fluid access device to allow fluid to flow into the catheter adapter through a fluid pathway separate from the septum, wherein the fluid pathway comprises the extension tube, a portion of the lumen distal to the septum, and the catheter.