Blood control catheter with antimicrobial needle lube

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.

BACKGROUND OF THE INVENTION

The current invention relates to a lubricant for dermally invasive devices. In particular, the present invention relates to methods and systems whereby an antimicrobial lubricant is applied to the outer surface of a catheter device to prevent infection.

Catheters are commonly used for a variety of infusion therapies. For example, catheters are used for infusing fluids, such as normal saline solution, various medicaments, and total parenteral nutrition into a patient, withdrawing blood from a patient, as well as monitoring various parameters of the patient's vascular system.

Catheters are commonly introduced into the vasculature of a patient as part of an intravenous catheter assembly. The catheter assembly generally includes a catheter adapter, which supports the catheter, the catheter adapter being coupled to a needle hub which supports an introducer needle. The introducer needle is extended and positioned within the catheter such that a beveled portion of the needle is exposed beyond a tip of the catheter. The beveled portion of the needle is used to pierce the skin of the patient to provide an opening whereby to insert the needle in the vasculature of the patient. Following insertion and placement of the catheter, the introducer needle is removed from the catheter thereby providing intravenous access to the patient.

Catheter-related bloodstream infections are caused by the colonization of microorganisms in patients with intravascular catheters and I.V. access devices. These infections are an important cause of illness and excess medical costs, as approximately 250,000 catheter-related bloodstream infections occur in United States intensive care units each year. In addition to the monetary costs, these infections are associated with anywhere from 20,000 to 100,000 deaths each year.

Impregnating catheters with various antimicrobial agents is one approach that has been implemented to prevent these infections. These catheters, however, have given less than satisfactory results. For example, these catheters are largely ineffective at preventing growth and colonization of pathogens on interior surfaces and components of a catheter assembly. In addition, some microbes have developed resistance to the various antimicrobial agents in the system.

Accordingly, there is a need in the art for dermally invasive devices having improved antimicrobial capabilities. Such methods and systems are disclosed herein.

BRIEF SUMMARY OF THE INVENTION

In order to overcome the limitations discussed above, the present invention relates to an antimicrobial lubricant matrix applied to a catheter device such that upon fully inserting the catheter device into a patient, the antimicrobial lubricant is interposed between the catheter and the dermal layers of the patient.

In some implementations, an antimicrobial formulation is provided as an insoluble lubricant material that is applied to an outer surface of an introducer needle as part of an intravenous catheter assembly. The lubricant material is applied so that as the needle is withdrawn through a blood control septum of the catheter assembly, a slit of the septum “squeegees” or otherwise removes a portion of the lubricant material from the outer surface of the needle. The removed lubricant material collects on the membrane and slit of the septum to provide a physical barrier between the slit and the vasculature of the patient. In some instances, a portion of the removed lubricant material is deposited within the slit, thereby further closing or sealing the slit.

In some instances, the lubricant material further comprises a lubricious agent. The lubricious agent reduces friction between the slit and the outer surface of the needle. As such, the needle may be removed through the septum in smooth and continuous manner without catching or otherwise damaging the septum's slit. The lubricious agent of the lubricant material may further reduce friction between the septum and an external Luer device that is inserted through the slit. The antimicrobial lubricant may be transferred to the Luer device as it is inserted through the slit, thereby killing any pathogens present thereon. In some implementations, the antimicrobial lubricant further includes an anti-thrombogenic agent to decrease the likelihood of blood clots within the catheter assembly.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiment of the present invention will be best understood by reference to the drawings, wherein like reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of presently preferred embodiments of the invention.

Referring now toFIG. 1, a catheter device assembly10is shown. In general, a catheter device assembly10in accordance with the present invention provides access to the vasculature of a patient, such as for infusion therapy procedures or blood collection. In some embodiments, catheter device system10comprises a catheter adapter30which supports a catheter tube40. Catheter tube40extends outwardly from catheter adapter30and is in fluid communication therewith.

In some embodiments, catheter device system10further comprises a needle hub (not shown) which supports an introducer needle50. Introducer needle50is threadedly positioned through catheter adapter30and catheter tube40such that a beveled tip52of needle50extends beyond catheter tip42. Beveled tip52provides a cutting surface whereby to penetrate the patient's skin and provide access to the patient's vasculature. Once catheter40is fully inserted into the patient, introducer needle50is removed thereby providing intravenous access to the patient20via catheter40and catheter adapter30.

In some embodiments, catheter adapter30further comprises a blood control septum20. Blood control septum20is provided as a physical barrier to control the flow of blood and other fluids between the forward chamber32and the rearward chamber34of catheter adapter30. For example, upon insertion of beveled tip52and catheter tip42into the patient's vein and the removal of the needle50, blood from the patient flows through lumen44of catheter tube40and into forward chamber32. The patient's blood is prevented from bypassing septum20, thereby retaining the blood in forward chamber32. Without blood control septum20in place, blood would flow into rearward chamber34and out of opening36in an uncontrolled manner. This would result in undesirable exposure of the user to the patient's blood. Accordingly, blood control septum20is positioned in fluid pathway38of catheter adapter30to prevent the user from being exposed to the patient's blood.

In some instances, blood control septum20is seated into an annular groove31that is provided in the inner surface33of catheter adapter30. In some embodiments, blood control septum20comprises an outer diameter that is greater than an inner diameter of fluid pathway38, and is slightly larger than the diameter of annular groove31. Thus, blood control septum20is seated into annular groove31and is prevented from moving within fluid pathway38in proximal12and distal14directions. In other instances, the outer peripheral edge of blood control septum20is secured to inner surface33via an adhesive, plastic weld, or other mechanical connection (such as a retainer clip).

Blood control septum20may comprise any structural configuration which is capable of dividing fluid pathway38into forward and rearward chambers32and34. For example, in some embodiments blood control septum20comprises a disc. In other embodiments, blood control septum20comprises a cylinder having a proximal opening22and a distal cap forming a membrane24. In some embodiments, membrane24comprises a slit26or a plurality of slits which form a pathway through membrane24. Slit26may be configured to permit passage of introducer needle50through septum20.

The resilient or stretchy nature of septum20permits slits26to stretch and thereby accommodate passage of needle50. In some instances, a seal or interface between slit26and the outer surface of needle50is sufficiently tight so that slit26prevents passage of fluid from forward chamber32to rearward chamber34when needle50is moved in proximal direction12. Further, blood that is present on outer surface54of the portion of needle50located in forward chamber32is removed or “squeegeed” from outer surface54as needle50moved through slit26in proximal direction12. Upon complete removal of needle50from slit26, slit26self-closes, thereby further preventing fluid within forward chamber32from passing into rearward chamber34.

Typically, the introducer needle50is coated with an oily lubricant that helps to reduce the system drag during needle removal. In some embodiments, the lubricant further comprises an antimicrobial agent forming an antimicrobial lubricant60. The antimicrobial lubricant60is provided as a means for preventing colonization and growth of microbes and pathogens within catheter assembly10. In some embodiments the antimicrobial lubricant60is applied to entire outer surface54of needle50. In some instances, the antimicrobial lubricant60is applied to the portion of outer surface54that is located in forward chamber32. During clinical usage, as the introducer needle is removed from the catheter, part of the antimicrobial lubricant60is removed or “squeegeed” from outer surface54as needle50moved through slit26in proximal direction12, forming an antimicrobial barrier on the septum surface and within the slit26. In this way, antimicrobial lubricant60acts as a barrier to prevent bacterial contamination of fluids the catheter.

In some embodiments, an antimicrobial lubricant is insoluable in most infusates and blood thus stay on the septum surfaces during multiple procedures, such as blood drawings, drug infusion, TPN procedures, as well as saline and heparin flushes. Therefore the antimicrobial lubricant can provide long lasting antimicrobial protection.

The formulations of the lubricant in this invention are comprised of a mixture or combination of one or more lubricants, and antimicrobial agents. In the mixture, the antimicrobial agents are uniformly and permanently distributed throughout the lubricant matrix.

In some embodiments, antimicrobial lubricant60comprises at least one of a water soluble lubricant, an insoluble lubricant, a viscous gel lubricant, a solid lubricant and a shapeable lubricant.

In some embodiments, antimicrobial lubricant60comprises oil lubricant. The oil lubricant can be polydimethyl siloxane, polytrifluoropropylmethyl siloxane, or a copolymer of dimethylsiloxane and trifluoropropylmethylsiloxane. The viscosity of the oil lubricant can be from 20 cp to 1,000,000 cp. In some embodiments, a solvent is added to the oil lubricant with very high viscosity to facilitate application of the antimicrobial lubricant.

Antimicrobial lubricant60may be applied to outer surface54by dipping, brushing, spraying, or any other compatible techniques known in the art. In some embodiments, excess antimicrobial lubricant60is applied to outer surface54prior to assembling needle50into catheter assembly10. Needle50is inserted through septum20and into catheter40by providing an enlarged pathway through septum20. In this way, antimicrobial lubricant60is not displaced from outer surface54during assembly.

For example, in some embodiments as shown inFIG. 7, a threader80is inserted into opening36and through slit26of septum to bias slit26into an enlarged, opened position. The enlarged, opened position of slit26is generally greater than the diameter of the coated portion of introducer needle50. The coated portion of introducer needle50is threaded through slit26via threader80, and advanced through lumen44of catheter40until beveled tip52extends beyond catheter tip42. Once in position, threader80is removed from slit26and catheter adapter30. The resilient nature of septum20allows slit26to resume its closed position around outer surface54.

Antimicrobial lubricant60generally comprises an antimicrobial or biocidal agent effective against various forms and strains of bacteria which may cause infection within a patient. The terms “biocidal agent” or “biocide,” as used herein refer to an agent that destroys, inhibits and/or prevents the propagation, growth, colonization and multiplication of unwanted organisms. The term “organism” includes, but is not limited to, microorganisms, bacteria, undulating bacteria, spirochetes, spores, spore-forming organisms, gram-negative organisms, gram-positive organisms, yeasts, fungi, molds, viruses, aerobic organisms, anaerobic organisms and mycobacteria. Specific examples of such organisms include the fungiAspergillus niger, Aspergillus flavus, Rhizopus nigricans, Cladosprorium herbarium, Epidermophyton floccosum, Trichophyton mentagrophytes, Histoplasma capsulatum, and the like; bacteria such asPseudomanas aeruginosa, Escherichia coli, Proteus vulgaris, Staphylococcus aureus, Staphylococcus epidermis, Streptococcus faecalis, Klebsiella, Enterobacter aerogenes, Proteus mirabilis, other gram-negative bacteria and other gram-positive bacteria, mycobactin and the like; and yeast such asSaccharomcyces cerevisiae, Candida albicans, and the like. Additionally, spores of microorganisms, viruses and the like are organisms within the scope of the present invention.

Antimicrobial or biocide agents suitable for use in the present invention include, but are not limited to phenol, quaternary ammonium, guanidine, taurolidine, parachlorometaxylenol, silver sulfadiazine, silver oxide, silver nitrate, pyridinium, benzalkonium chloride, cetrimide, benethonium chloride, cetylpyridinium chloride, dequalinium acetate, dequalinium chloride, and chloroxylenol. Further, in some embodiments lubricant60comprises a microbial agent selected from chlorhexidine base, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine hydrochloride, chlorhexidine dihydrochloride, dibromopropamidine, halogenated diphenylalkanes, carbanilide, salicylanilide, tetrachlorosalicylanilide, trichlorocarbanilide, and mixtures thereof. Still further, in some embodiments lubricant60comprises a microbial agent selected from chlorhexidine dihydrochloride, chlorhexidine gluconate, chlorhexidine acetate, chlorhexidine diacetate, triclosan, chloroxylenol, dequalinium chloride, benzethonium chloride, benzalkonium chloride, and combinations thereof. The antimicrobial agent can be solid particles that are insoluable in the lubricant or in liquid form. The antimicrobial agent is well mixed within the lubricant prior to application to introducer needles.

In some embodiments, lubricant60comprises one or more antimicrobial agents in an amount from approximately 0.01% (w/v) to approximately 10.0% (w/v) of lubricant60. In other embodiments, lubricant60comprises one or more antimicrobial agents in an amount from approximately 0.001% (w/v) to approximately 5.0% (w/v) of lubricant70. Further, in some embodiments lubricant60comprises one or more antimicrobial agents in an amount from approximately 0.01% to approximately 10.0% (w/v).

In some embodiments, lubricant60further comprises one or more fugitive solvents, such as tetrahydrofuran (THF), methylethylketone (MEK) and hexane solvents. In some embodiments, lubricant60comprises a fugitive solvent in an amount approximately equal to 70% (w/v) of lubricant60. In other embodiments, lubricant60comprises two or more fugitive solvents.

In other embodiments, lubricant60comprises one or more alcohol components. Suitable alcohol components generally include a lower alcohol having between one and six carbons (C1-C6). In some embodiments, lubricant60comprises an alcohol component selected from the group consisting of ethyl alcohol, isopropanol, propanol, and butanol. In other embodiments, lubricant60comprises two or more lower alcohol components, for example a mixture of isopropyl alcohol and ethyl alcohol in a ratio of about 1:10 to about 1:1. Further, in some embodiments lubricant70comprises a mixture of more than two alcohol components.

In some embodiments, lubricant60comprises an alcohol component in an amount approximately equal to 40% (w/v) of lubricant60. In other embodiments, lubricant60comprises an alcohol component in an amount from approximately 20% (w/v) to approximately 95% (w/v).

In some embodiments, antimicrobial lubricant60further comprises a lubricant, such as silicon oil. In some embodiments, introducer needle50is coated with a high viscosity antimicrobial lubricant60to reduce adhesion between the needle50and the catheter tip42, as well as between the needle50and the septum20. Upon withdrawing needle50from catheter40and septum20, slit26of septum20rubs against the outer surface54of the needle50, thereby removing excess lubricant60, as shown inFIG. 2.

In some embodiments, antimicrobial lubricant60further comprises an anti-thrombogenic agent. An anti-thrombogenic agent is provided to decrease the likelihood of blood clotting within catheter assembly10. In some instances, an anti-thrombogenic agent is provided to decrease the likelihood of blood clotting within forward chamber32or on any surface coated by antimicrobial lubricant60.

Referring now toFIG. 2, catheter assembly10is shown having introducer needle50partially withdrawn. In some embodiments, excess antimicrobial lubricant60is “squeegeed” or removed from outer surface54as needle50is withdrawn through slit26of septum20in proximal direction12. Excess lubricant60collects within forward chamber32thereby providing a barrier between membrane24and forward chamber32. This barrier will kill microorganisms that come in contact with and/or in close proximity of lubricant preventing microbial growth and colonization on membrane24and generally within forward chamber32.

Upon complete withdrawal of introducer needle50from septum20, slit26self-closes thereby providing a further physical barrier between forward and rearward chambers32and34, as shown inFIG. 3. The barrier provided by excess antimicrobial lubricant60may further migrate to other surfaces in close proximity of the septum thus provide antimicrobial protection to the inside surfaces of the catheter beyond the septum.

In some embodiments, slit26of blood control septum20comprises a tri-slit configuration, as shown inFIG. 4. Following removal of needle50, excess antimicrobial lubricant60is deposited on membrane24thereby covering slit26. Antimicrobial lubricant60prevents colonization and growth of pathogens on membrane24.

In some embodiments, excess antimicrobial lubricant60migrates into slit26thereby filling any gaps or openings in slit26, as shown inFIG. 5. In this manner, excess antimicrobial lubricant60assists septum20in preventing flow of fluids between forward and rearward chambers32and34.

Some implementations of the present invention further include a method for lubricant a septum of a blood control catheter with antimicrobial needle lube, as outline inFIG. 6. In some instances, a first step lubricant the septum comprises applying an antimicrobial lubricant to an outer surface of an introducer needle (at step100). The coated needle is then inserted through the slit of a septum disposed within a catheter assembly (at step200). In some instances, a threader is first inserted into the slit of the septum to provide an enlarged opening. In this manner, the antimicrobial lubricant is prevented from being displaced during the assembly of the device. Once positioned within the catheter assembly, the threader is removed from the slit and the device is ready for use.

The septum is coated as the needle is withdrawn from the septum and the catheter assembly device (at step300). As the needle is withdrawn, the slit of the septum squeegees excess antimicrobial lubricant from the outer surface of the needle. This excess antimicrobial lubricant is deposited on membrane and slit portions of the septum. In some instances, excess antimicrobial lubricant is deposited within a forward chamber of the catheter assembly device to form an additional barrier between the septum and the vasculature of the patient.

FIGS. 8-10illustrate another catheter assembly82, according to some embodiments. In some embodiments, the catheter assembly82may correspond to the catheter assembly10, illustrated inFIGS. 1-5. For example, in some embodiments, the septum88may correspond to the septum20ofFIGS. 1-5. In some embodiments, the catheter assembly82may include, but is not limited to, the BD Diffusics™ Closed IV Catheter System, the BD Nexiva™ Closed IV Catheter System, the BD Intima II™ Closed IV Catheter System, or the BD Saf-T-Intima™ Closed IV Catheter System, available from Becton, Dickinson, and Company.

In some embodiments, a proximal end of the catheter adapter86may be sealed with the septum88to ensure that fluid does not exit or leak out of the proximal end of the catheter adapter86. In some embodiments, the septum88may be formed from one piece. In some embodiments, the septum88may be formed from two portions, a proximal portion88aand a distal portion88b.

In some embodiments, the septum88may include a slit. In further detail, in some embodiments the septum88may be pre-slit prior to insertion of the introducer needle90through the septum88or the slit may be formed when the introducer needle90is inserted through the septum88. For example, in some embodiments, one or more of the proximal portion88aand the distal portion88bmay be pre-slit to facilitate locating an introducer needle90therethrough, or one or more of the proximal portion88aand the distal portion88bmay not be pre-slit but may instead may be slit when the introducer needle90is inserted therethrough. In some embodiments, the septum distal portion88bmay provide the primary seal preventing fluid flow past septum88while septum proximal portion88amay provide a secondary seal. Suitable materials for septum88may include a peroxide cured elastomer such as polyisoprene, silicone, and the like where the materials have a durometer in the range of 35-45 Shore A.

In some embodiments, the catheter adapter86may include a side port92, which may include an extension tube94connected thereto. In some embodiments, attachment of another medical device to the proximal end of the catheter adapter may be prevented, for example, by a housing95which may surround at least a portion of the septum88. Instead, any such medical device that may be connected to the catheter adapter86should be connected to a fluid access device (not illustrated) disposed at a proximal end of the extension tube94. In some embodiments, the proximal end of the extension tube94may include a luer lock adapter or other fluid access device to allow connection of an IV fluid supply line to the extension tube94. In some embodiments, the side port92may be in fluid communication with a lumen of the catheter96so that fluid infused through the extension tube94may pass into a patient once the catheter96is properly positioned in the patient. Conversely, in some embodiments, blood exiting a patient's vein through the catheter96may travel through the extension tube94.

In some embodiments, a fluid pathway for fluid infused through the extension tube94and/or blood exiting the patient's vein may include at least the extension tube94, a portion of a lumen of the catheter adapter86distal to the septum88, and a lumen of the catheter96. In some embodiments, the septum88may be separate from the fluid pathway. For example, the fluid pathway may not extend through the septum88, and the septum88may prevent fluid in the fluid pathway from exiting the proximal end of the catheter adapter86.

In some embodiments, the septum88may be disposed in the catheter adapter86so that at least a distal portion of septum distal portion88bengages the inside of the catheter adapter86. In some embodiments, an external diameter of at least the distal portion of septum distal portion88bmay be greater than an internal diameter of catheter adapter86at least along the portion that engages the distal portion of septum distal portion88b. In some embodiments, the external diameter of the distal portion of septum distal portion88bmay be at least 5% larger than the internal diameter of the relevant portion of the catheter adapter86. With this configuration, the catheter adapter86may exert a radial compressive force against the distal portion88b. This compressive force may help to seal the septum distal portion88bafter the introducer needle90has been withdrawn from the septum88so that septum distal portion88bdoes not take a compression set about introducer needle90. In some embodiments, the portion of the catheter adapter86that engages septum distal portion88bmay be arranged such that a proximal end of septum88is adjacent to the open proximal end of catheter adapter86when the catheter adapter86engages the septum distal portion88b. In some embodiments, the septum88may be affixed inside catheter adapter86using an alternate technique such as by an interference fit between the housing95and the catheter adapter86, the use of an adhesive, or by ultrasonic welding.

In some embodiments, the septum88may define a cavity or hollow interior portion88cformed between the septum proximal portion88aand the septum distal portion88b. In some embodiments, the hollow interior portion88cmay be between about 6 and about 8 millimeters in length. The hollow interior portion88cmay minimize drag on the introducer needle90as it is being withdrawn from the catheter assembly82.

In some embodiments, the septum88may have a thickness or length of between 9 and 14 millimeters. In some embodiments, the septum88may have a thickness or length of between 4 and 14 millimeters.

In some embodiments, the antimicrobial lubricant60may include a silicone lubricant, which may have a viscosity of about 1,000,000 cp. In some embodiments, the viscosity of the antimicrobial lubricant60may be from 20 cp to 1,000,000 cp. In some embodiments, the antimicrobial lubricant60may include one or more antimicrobial agents in an amount from approximately 0.5% (w/v) to approximately 14.0% (w/v) of the antimicrobial lubricant60.

In some embodiments, the antimicrobial lubricant60may be applied to at least a portion of an outer surface of the needle90. In some embodiments, the antimicrobial lubricant60may be applied to only a portion of an outer surface of the needle90. In some embodiments, the portion may be disposed distal to the septum88when the needle extends beyond the distal end of the catheter96and/or before the needle90is withdrawn or partially withdrawn following insertion into the vasculature of the patient. In some embodiments, the portion may extend from a distal portion of the needle90to a distal end of the septum88when the needle extends beyond the distal end of the catheter96and/or before the needle90is withdrawn or partially withdrawn following use. In some embodiments, the distal portion of the needle90may include a beveled tip of the needle90.

In some embodiments, the needle90may be coated with the antimicrobial lubricant60to reduce adhesion between the needle90and a catheter tip98, as well as between the needle90and the septum88. Upon withdrawing the needle90from the catheter96and the septum88, the slit102of the septum88may rub against an outer surface of the needle90, thereby removing excess lubricant60, as illustrated inFIG. 2-3.

In some embodiments, when the antimicrobial lubricant60is applied to a portion of the outer surface of the needle90proximate a distal end of the septum and/or distal to the distal end of the septum, this may allow the antimicrobial lubricant to be deposited on the distal end of the septum and/or the slit102of the septum88during insertion of the needle90through the distal opening of the catheter adapter86when the catheter assembly82is prepared for insertion into the vasculature of the patient. In some embodiments, the septum88may be pre-slit to include the slit102. In some embodiments, the slit102may be formed in response to insertion of the introducer needle90through the septum88.

Some implementations of the present invention may include a method400of lubricating a septum of a catheter assembly with an antimicrobial coating or lubricant, as illustrated inFIG. 11. In some embodiments, a first step402of the method400may include applying the antimicrobial lubricant to at least a portion of an outer surface of an introducer needle. In some embodiments, the antimicrobial lubricant may be applied to only a portion of the outer surface of a body of the needle. In some embodiments, the portion may be proximate to a distal end of the septum when the needle extends beyond the distal end of a catheter of the catheter assembly and/or before the needle is withdrawn or partially withdrawn following insertion into the vasculature of the patient. In some embodiments, the first step402may be followed by a second step404.

In some embodiments, a second step404of the method400may include preparing the catheter assembly for insertion into the vasculature of the patient by inserting the needle, having the antimicrobial lubricant applied thereto, proximally through a distal opening of the catheter adapter and/or a distal opening of the catheter such that the body of the needle extends through the septum and the tip of the needle extends beyond the distal end of the catheter. In embodiments in which the antimicrobial lubricant is applied to a portion of the outer surface of the needle, the portion may be disposed distal to a distal end of the septum.

In some embodiments, when the body of the needle extends through the septum, a slit of the septum may seal 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 outer surface of the needle to form a deposit of the antimicrobial lubricant on the septum at a location proximate to the slit. In some embodiments, when the needle is inserted proximally through the distal opening of the catheter adapter and/or a distal opening of the catheter, a threader may not be needed to prevent the antimicrobial lubricant from being displaced during assembly of the device.

The second step404may not be preferred with the septum20illustrated inFIGS. 1-5, which may include a membrane, as insertion of the needle proximally through the septum20may cause the septum20to adopt a concave configuration. In contrast, in some embodiments, a thickness of the septum88, illustrated inFIGS. 8-10, may allow the needle to be inserted proximally through the septum20without disruption of a shape of the septum88. In some embodiments, the second step404may be followed by a third step406.

In some embodiments, the third step406of the method400may include inserting the needle and the catheter positioned around the needle into vasculature of a patient. In some embodiments, the third step406may be followed by a fourth step408.

In some embodiments, the fourth step408may include withdrawing the needle from the slit of the septum to deposit the antimicrobial lubricant on the septum and the slit. As the needle is withdrawn, the slit of the septum may squeegee excess antimicrobial lubricant from the outer surface of the needle. This excess antimicrobial lubricant may be deposited on the distal end of the septum and at least an outer surface of the slit of the septum. In some embodiments, this excess antimicrobial lubricant may be deposited within at least a distal portion of the slit.

The present invention may be embodied in other specific forms without departing from its structures, methods, or other essential characteristics as broadly described herein and claimed hereinafter. For example, the present invention may be applied to any dermally invasive device, such as needles, scalpels, trocars, endoscopes, stoma appliances, and the like. The described embodiments are to be considered in all respects only as illustrative, and not restrictive. The scope of the invention is, therefore, indicated by the appended claims, rather than by the foregoing description. All changes that come within the meaning and range of equivalency of the claims are to be embraced within their scope.