Needleless Access Connector with Antibacterial Resistant Valve

Abstract

A valve containing an antimicrobial agent can be used with the needleless access connector. The valve can have an insert containing an antimicrobial coating, and / or the valve can have a physical feature, such as a series of tunnels or grooves or a patterned surface, that houses the antimicrobial compound, and / or the valve can be made from a material that contains the antimicrobial agent.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to needleless connectors, and more particularly to needleless connectors having antimicrobial resistant valves. [Background technology]

[0002] Needleless access connectors (NACs) are widely used throughout the medical industry to connect and disconnect sources of medical fluids (e.g., saline or liquid medications) intended to be infused into patients. Such connectors are commonly used with IV catheters, which are connected to a fluid source, such as an IV bag, via an arrangement of flexible tubing and fittings commonly referred to as an "intravenous (IV) set."

[0003] When connected to a NAC, access hubs and ports / valves can introduce bacteria and other microorganisms into the patient's vascular system. Each access hub (or port / valve or connection) is associated with some risk of transferring a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0004] To reduce the incidence of catheter-related bloodstream infections (CRBSIs) and ensure connectors are used and maintained correctly, standards of practice have been developed, including disinfection and cleaning techniques. For example, the 2016 Infusion Nurses Standard (INS) guidelines recommend that needleless connectors should always be thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access.

[0005] Disinfection of needleless connectors is fundamentally intended to help reduce bacteria that may inhabit surfaces and potentially cause various catheter-related complications, including the aforementioned CRBSI events. Nurses commonly complete this disinfection task by performing what is known as "scrubbing the hub" with a 70% IPA alcohol pad. However, compliance with and effectiveness of this practice do not appear to be strict. Furthermore, to reduce infections due to potential bacterial growth, healthcare professionals tend to change NAC connectors frequently, e.g., at least weekly. However, there is a continuing need to reduce the potential for bacterial infection and extend the useful life of needleless access connectors. Summary of the Invention

[0006] Aspects of the subject technology relate to needleless access connectors having valves that can resist bacterial growth, and particularly to needleless access connectors having access ports with antibacterial resistant valves.

[0007] In some embodiments, the NAC valve has a head and a body extending distally from the head, the head having an upper surface, and an antimicrobial agent disposed on various surfaces of or within the valve. In other embodiments, an insert is included within the valve that has the antimicrobial agent. In further embodiments, the valve is the only component of the needleless access connector that contains the antimicrobial agent.

[0008] Embodiments include one or more of the following features, individually or in combination. For example, the valve, including its upper surface, can comprise a silicone elastomer. In some embodiments, the valve can have a porous upper surface and include an insert near the porous upper surface of the valve, the insert having an antimicrobial coating thereon that includes an antimicrobial agent. Further, the insert can have a flat upper surface that is near the porous upper surface of the valve. In other embodiments, the valve can have a series of tunnels or bores in the upper surface of the valve, the tunnels and / or bores containing an antimicrobial formulation that includes an antimicrobial agent. Alternatively or additionally, the valve can have a series of grooves or textured patterns that contain the antimicrobial formulation that includes an antimicrobial agent. Further, the valve can have a material that includes an antimicrobial agent, for example, the valve can include a silicone elastomer, a fluoropolymer, and an antimicrobial agent. In still further embodiments, the valve material can include the antimicrobial agent by infusing the antimicrobial formulation into the upper surface of the valve. In yet another embodiment, the antimicrobial formulation can be a sustained-release antimicrobial formulation and can include a polymer-forming component such as a biodegradable polymer, a mesh-forming polymer, a temperature / pH-sensitive polymer, or a combination thereof, or a curable adhesive component. The antimicrobial agent can be included in a coating on or within the valve, and the antimicrobial agent can have from about 0.5 to about 50 parts by weight relative to 100 parts by weight of the formulation used to form the coating.

[0009] Further advantages of the subject technology will become readily apparent to those skilled in the art from the following detailed description, in which only certain aspects of the subject technology are shown and described by way of example only. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects, all without departing from the scope of the subject technology. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

[0010] The accompanying drawings, which are included to provide a further understanding and are incorporated in and constitute a part of this specification, illustrate disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. [Brief explanation of the drawings]

[0011] [Figure 1A] FIG. 1 is a diagram of an example useless access connector, a three-dimensional view showing the components of the useless access connector in an unassembled form. [Figure 1B] FIG. 10 is a diagram of an example useless access connector, showing a cutaway view of an assembled useless access connector in a closed state. [Figure 1C] FIG. 1 is a diagram of an example useless access connector; FIG. 2 is a cutaway view of an assembled useless access connector showing the open state. [Figure 2A] FIG. 10 is a diagram of an example valve for a useless access connector, and a diagram showing a valve for a NAC with an insert near the porous top surface of the valve. [Figure 2B] FIG. 10 is a diagram of an example valve for a useless access connector, showing an insert having an upper surface containing a pocket or cleft. [Figure 3] FIG. 10 shows an example valve for a useless access connector, with physical features on the top surface of the valve that can accommodate an antimicrobial coating or formulation. DETAILED DESCRIPTION OF THE INVENTION

[0012] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details to provide a thorough understanding of the subject technology. Accordingly, dimensions are provided with respect to particular embodiments as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specific details. In some cases, well-known structures and components are shown in block diagram form to avoid obscuring the concepts of the subject technology.

[0013] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to specific, but non-limiting examples. The various embodiments described in this disclosure can be implemented in different ways and variations according to a desired application or implementation.

[0014] Aspects of the subject technology relate to needleless access connectors (NACs) having valves, e.g., valves made from silicone elastomers with antimicrobial agents. In some embodiments of the present disclosure, the valves have an insert with an antimicrobial coating on the insert that includes the antimicrobial agent, and / or physical features, such as a series of tunnels or grooves or patterned surfaces, that contain an antimicrobial formulation that includes the antimicrobial agent, and / or the valves are made from a material that includes the antimicrobial agent.

[0015] Advantageously, although not exclusively, the valve is the only component of the needleless access connector that contains an antimicrobial agent. A needleless access connector having a valve as the only component of the needleless access connector that contains an antimicrobial agent can reduce the amount of antibiotic available with the flow of medical fluid through the connector, thus reducing antibiotic dosage to the patient using a NAC or the like. Reducing antibiotic dosage is particularly advantageous when two or more NACs are used to deliver fluids to the patient. Furthermore, a valve containing a sustained-release antimicrobial coating can advantageously extend the useful life of the NAC, thereby reducing the need for frequent NAC replacement over a given period of time.

[0016] An example needleless access connector using a valve is shown in FIGS. 1A-1C. FIG. 1A is a three-dimensional view showing the components of the needleless access connector 100 in an unassembled configuration. FIGS. 1B and 1C are cutaway views of the assembled needleless access connector 100, showing the closed and open configurations, respectively. As shown with respect to this example, the needleless access connector 100 includes a housing 102 having a proximal end 104 defining an access port 114 and a distal end 106 defining an exit port 116 of the housing 102. As referred to herein, proximal refers to the direction toward the top access port 114 of the housing 102, and distal refers to the direction toward the base 106 or bottom side of the housing 102, opposite the top access port 114.

[0017] The housing 102 includes an internal cavity 140 extending at least partially between the proximal end 104 and the distal end 106. The needleless access connector 100 also includes a compressible valve 200 disposed within the internal cavity 140 of the housing 102. The compressible valve 200 includes a head portion 220 and a compressible body portion 230 extending distally from the head portion 220. For this example, the compressible valve is shown with a notch configuration in the head portion, although these notches may be required to practice various aspects of the present disclosure.

[0018] The access port 114 can include an engagement mechanism 101 for coupling to another device (e.g., a fluid transfer assembly). For example, the engagement mechanism 101 can include cooperating mechanical elements such as internal or external threads, detents, bayonet-style locking elements, etc., and other surface configurations, such as a tapered luer surface for frictional engagement. In some embodiments, the inlet port 114 can define a female luer that mates with the luer-lock threading 101. In some embodiments, the outlet port 116 can include an engagement mechanism for coupling to another device or to interconnecting tubing. For example, the outlet port 116 can have a male luer-taper fitting and luer-lock threading 103 for medical device / instrument interconnection. However, the engagement mechanism of the outlet port 116 can include other cooperating mechanical elements. In operation, a fluid pathway can be established from the inlet port 112 to the outlet port 108, for example, via a needleless connector.

[0019] In operation, the compressible valve 200 of the needleless connector can compress and collapse when an axial force is applied to the top surface 204 of the compressible valve 200, and the valve can expand and realign when the axial force is removed. Thus, when an axial force (F) is applied to the top surface 204 of the valve, the valve 200 compresses within the internal cavity 130 of the housing 102, allowing a fluid path from the access port 114 to the exit port 116. As an example shown in FIG. 1C , a male luer fitting 160 having a hollow member (as shown in FIG. 1C ) can be connected to the access port 114 via the female fitting 101. Insertion of the male luer 160 collapses the valve 200 downward into the internal cavity 130, breaking the seal with the head 220 of the valve 200 and opening the fluid flow path 109 from the access port 114 to the exit port 116. 1C shows the collapsible valve 200 in a collapsed position after insertion of the male luer 160 into the female luer 101. The male luer 160 delivers fluid, for example from an IV bag, which flows through the internal cavity 130, around the valve element 200, into a channel in the male luer fitting 103, and into the catheter or female luer.

[0020] The housing 102 can comprise one or more rigid polymeric materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic acid or acrylates, or combinations thereof. The valve 200, including the head 220 and the upper surface 204, can comprise a resilient, inert material, such as a silicone elastomer, so that the valve is collapsible within the housing 102 and prevents adverse interaction with the medicated fluid.

[0021] While current NAC designs are robust enough to resist bacterial intrusion, access ports are of particular concern because they are typically exposed to the environment when not connected to a medical device. However, NACs with valves that have antimicrobial agents, particularly on the face side and upper surface of the valve, also known as the access port side, can minimize or eliminate bacterial formation or growth, and these conditions can be maintained for extended periods of time, such as during use for a week or more. Thus, in one embodiment of the present disclosure, NACs have valves with silicone elastomers that contain antimicrobial agents, such as by sustained-release antimicrobial coatings or formulations on or within the valve.

[0022] In one embodiment of the present disclosure, an insert having an antimicrobial coating is included within the NAC valve. The insert may be included near the top surface of the valve. An example needleless access connector using a valve with an insert is shown in FIGS. 2A and 2B. In such an embodiment, the valve 300 includes holes in its top surface 304 (e.g., a porous top surface) of the head 320 of the valve 300, allowing the antimicrobial agent to leach from the insert through the valve to the exterior surface of the valve. Additionally, the porous top surface may allow liquids, such as medical fluids, to enter the insert, sterilizing the fluid or other fluids and allowing the antimicrobial agent liquid, e.g., chlorhexidine salts, to leach from the insert and eradicate microorganisms.

[0023] In some embodiments, the insert can have a flat top (shown as 352 in FIG. 2A ) and be positioned so that the flat top is generally parallel to the porous top surface (e.g., 304) of the head of the NAC valve. Additionally or alternatively, the insert can include pockets or crevices that can act as reservoirs for the antimicrobial coating to be placed therein. FIG. 2B shows an example insert 360 having a top surface that includes a pocket or crevices (364) that accommodates the antimicrobial coating or compound within the pocket or crevices. For this example, the insert 360 is contained within the head 320 of the valve, and the top of the valve includes a porous top surface (not shown). The pocket or crevices in the insert can advantageously facilitate keeping the insert in place within the valve by trapping the overmolded valve material within and / or around the pocket or crevices.

[0024] In certain embodiments of the present disclosure, the insert can be rigid and can comprise one or more hard polymeric materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene butadiene rubber (SBR), polyacrylic acid or acrylates, or combinations thereof. Rigid inserts have the advantage that such inserts in the upper portion of the valve can make the upper surface of the valve more rigid and less likely to conform around an instrument, such as a syringe, connected to the access port, thereby facilitating a consistent or wider flow path for fluids delivered through the NAC.

[0025] In another aspect of the present disclosure, the NAC valve can have physical features, such as a series of tunnels or grooves or patterned surfaces, that contain an antimicrobial compound containing an antimicrobial agent. For example, as shown in FIG. 3, the NAC valve 400 can have a series of tunnels or bores (450) in the valve's top surface (404), which can be created by molding the valve with such features. The tunnels and / or bores can be filled or otherwise contain an antimicrobial compound containing an antimicrobial agent, for example, a chlorhexidine salt formulated with an adhesive.

[0026] In another aspect of the present disclosure, a NAC valve can have a series of grooves on its surface. The grooves can be on the top surface of the valve head and / or on the body surface of the valve. Such grooves can be formed as a micro-pattern and / or textured surface of the valve. Such grooves / micro-patterns can be molded into the part. The grooves can then be filled with an antimicrobial compound containing an antimicrobial agent, for example, a chlorhexidine salt formulated with an adhesive, resulting in a valve with a series of grooves or textured pattern containing the antimicrobial compound. When a valve with an antimicrobial coating in or on its physical features comes into contact with a fluid, the water-soluble antimicrobial agent contained in the coating can be released from the valve, thereby imparting antimicrobial properties to the contacting fluid and surrounding surfaces.

[0027] In another aspect of the present disclosure, the valve of the NAC can have one or more hydrophilic surfaces and an antimicrobial coating on the one or more hydrophilic surfaces, the antimicrobial coating including an antimicrobial agent.

[0028] As described above, NAC valves can include a head and a body. Such valves are typically made from inert materials, such as silicone elastomers. However, adhering a sustained-release antimicrobial coating to such materials can be challenging due to their relative inertness and the flexibility required of the valve. To better incorporate the antimicrobial agent into such valves, the surface of the valve can be modified.

[0029] Thus, in one embodiment of the present disclosure, the valve surface is treated to make the surface more hydrophilic than an untreated surface. Such treatment can include, for example, treatment with an alcohol, such as isopropyl alcohol (IPA). The surface can also be made more hydrophilic by treating the valve surface with oxygen plasma, argon, or both. The surface can also be made more hydrophilic by applying a primer to the valve surface followed by an antimicrobial coating, such as an adhesive antimicrobial formulation (UV-curable silicone adhesive; urethane-acrylate curable adhesive formulation with CHA / CHG). Such primers are available from companies such as Henkel and Loctite.

[0030] Another way to facilitate the inclusion of antimicrobial agents in NAC valves is to roughen the valve surface for better adhesion of the antimicrobial coating. Additionally, the surface can be subjected to ionizing bombardment of the antimicrobial agent, e.g., CHA, to modify the surface.

[0031] In another aspect of the present disclosure, the NAC valve can include an antimicrobial agent as part of the valve material. Preferably, the antimicrobial agent is dispersed approximately uniformly within the valve material. One way to achieve this is to blend the antimicrobial agent into the valve material, such as a silicone elastomer. Other polymeric compounds can also be blended with the valve material and antimicrobial agent. Such polymeric components include, for example, inert materials such as fluoropolymers, e.g., polytetrafluoroethylene (PTFE), and hydrophilic polymers, e.g., polyvinylpyrrolidone (PVP). Hydrophilic polymers can have the advantage that they can spread to surfaces upon contact with fluids, and hydrophilic polymers have a tendency to spread to surfaces, which can then elute the antimicrobial agent.

[0032] Another way to include an antimicrobial agent as part of the valve material is to blend the silicone elastomer with another silicone material that has hydrophilic chains to form a valve with a hydrophilic surface.

[0033] Another way to incorporate an antimicrobial agent into the valve material is to immerse the valve in a solution containing the antimicrobial agent, which causes the valve to expand and the agent to become incorporated into the valve material. For example, a valve constructed from a silicone elastomer can be immersed in a solution of an antimicrobial agent, such as a chlorhexidine salt. The valve expands in the solution, allowing some of the antimicrobial agent to soak into the valve material.

[0034] Another way to include antimicrobial agents in the NAC valve is to inject an antimicrobial compound into the top or port surface of the valve, such as with a hypodermic needle. When the needle is inserted into the top surface of the valve, a chlorhexidine / adhesive mixture is injected. This mixture continues to inject even after the needle is removed, filling any voids left by the needle.

[0035] Useful antimicrobial agents that can be included in the NAC valve or with the formulation to prepare the antimicrobial coating of the present disclosure include, for example, aldehydes, anilides, biguanides, elemental silver or its compounds, bisphenols, and quaternary ammonium compounds, or combinations thereof. In particular, suitable antimicrobial agents of the present disclosure include, for example, triclosan, chlorhexidine gluconate (CHG), chlorhexidine acetate (CHA), chlorhexidine salts such as chlorhexidine phosphanylate, silver salts, and chlorhexidine / silver sulfadiazine.

[0036] Useful antimicrobial coatings or formulations of the present disclosure include one or more antimicrobial agents with one or more polymers. Alternatively, or in combination with one or more antimicrobial agents and polymers, the formulations can include polymer forming components, such as UV-curable monomers and / or oligomers. In some examples, the polymer components of the formed antimicrobial coating or formulation are such that they can release the antimicrobial agent over time, e.g., sustained-release coatings or formulations that can release the antimicrobial agent over time, such as over at least 7 days, 14 days, 21 days, etc. The molecular weight of the polymer in the formed coating can be adjusted to control the release rate of the antimicrobial agent.

[0037] Useful polymers that can be included in the formulation to prepare the antimicrobial coatings of the present disclosure include, for example, biodegradable polymers such as polylactic-co-glycolic acid (PLGA), polycaprolactone (PCL), polyglycolide (PGL), polylactic acid (PLA), poly-3-hydroxybutyrate (PBH), polysaccharides, polyethylene glycol (PEG), polyethylene oxide (PEO), mesh-forming polymers such as cellulose acetate, hyaluronic acid, temperature / pH-sensitive polymers such as poly(isopropylacrylamide) (NIPPam), and the like, or copolymers and / or combinations thereof.

[0038] Useful polymer-forming components that can be included in formulations to prepare the sustained-release antimicrobial coatings of the present disclosure include, for example, moisture- or temperature-curable adhesive components such as cyanoacrylates, and UV-curable adhesives such as urethane-acrylate-curable adhesives. The curable adhesive components can be formulated with one or more antimicrobial agents. UV-curable formulations can include a combination of urethane- or polyester-type oligomers with acrylate-type functionality, acrylate-type monomers, and antimicrobial agents, along with optional photoinitiators, rheology modifiers, and additives. The antimicrobial agent is preferably uniformly distributed throughout the coating matrix.

[0039] A wide variety of UV-curable oligomers can be used with the formulations of the present disclosure. For example, the oligomer can be an acrylated aliphatic urethane, an acrylated aromatic urethane, an acrylated polyester, an unsaturated polyester, an acrylated polyether, an acrylated acrylic, or the like, or a combination of the above. The acrylated functional group can be monofunctional, difunctional, trifunctional, tetrafunctional, pentafunctional, or hexafunctional.

[0040] As with oligomers, a wide variety of monomers may be used with the formulations of the present disclosure, including, for example, 2-ethyl hexyl acrylate, isooctyl acrylate, isobornyl acrylate, 1,6-hexanediol diacrylate, diethylene glycol diacrylate, triethylene glycol diacrylate, pentaerythritol tetraacrylate, pentaerythritol triacrylate, dimethoxyphenyl acetophenone hexyl methyl acrylate, dimethoxyphenyl acetophenone hexyl methyl acrylate, 1,6-hexanediol methacrylate, and the like, or combinations thereof.

[0041] To facilitate UV curing, UV-curable formulations can include sufficient and compatible photoinitiators. Such photoinitiators can be: 1) unimolecular cleavage-type photoinitiators, such as benzoin ether, acetophenone, benzoyl oxime, and acyl phosphine oxide; or 2) hydrogen abstraction-type photoinitiators, such as Michler's ketone, thioxanthone, anthrothione, benzophenone, methyl diethanolamine, 2-N-butoxyethyl 1-4-(dimethylamino)benzoate, or combinations thereof. UV-curable formulations can be rapidly cured, for example, by ultraviolet light; cure can be achieved in seconds or minutes, depending on the formulation and curing conditions. The sustained-release coatings of the present disclosure generally become effective within minutes.

[0042] The antimicrobial agent may be included in the formulations of the present disclosure in an amount of about 0.5 to about 50 parts by weight, such as about 1 to about 20 parts by weight, or about 0.5 to about 30 parts by weight of the formulation, based on 100 parts by weight of the formulation used to form the coating.

[0043] Some specific formulations that can be applied include, for example, a urethane-acrylate adhesive or cyanoacrylate adhesive with approximately 8 wt% CHA that can be applied to the surface of the NAC valve. Additionally, the surface of the NAC valve can be primed with a primer, such as primers for silicone valves available from companies such as Henkel and Loctite, followed by application of a formulation containing 8% CHA and curing the formulation to form a sustained-release antimicrobial coating on the valve. Silicone valves can be made more hydrophilic / wettable by plasma treatment, or the valve can be etched to allow the acrylate-urethane adhesive formulation to be coated onto the silicone valve.

[0044] The formulation for preparing the sustained-release coating of the present disclosure can be prepared by mixing the antimicrobial agent with a polymer, with or without a solvent, to form a slurry or solution. Alternatively, or in combination with mixing the antimicrobial agent with a polymer, the antimicrobial agent can be mixed with a polymer-forming component to prepare the sustained-release coating formulation. The formulation can then be applied to a surface by spray-coating, dip-coating, and / or rubbing the formulation onto the surface. For example, a curable formulation for preparing a sustained-release antimicrobial coating according to certain embodiments of the present disclosure can be prepared by creating a slurry of a polymer-forming component, such as a cyanoacrylate, together with about 8 wt % of a fine powder of an antimicrobial agent, such as CHA (the CHA can be milled to a fine mesh / pore size so that it can be mixed to form a uniform distribution of CHA in the formulation). The slurry can then be applied to the NAC valve.

[0045] It is understood that any specific order or hierarchy of blocks in the disclosed process methods is an example of an example approach. Based on design or implementation preferences, it is understood that the specific order or hierarchy of steps, blocks in the processes may be rearranged, or all of the blocks shown may be performed. In some embodiments, any of the blocks may be performed simultaneously.

[0046] This disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. This disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0047] Reference to an element in the singular is intended to mean "one or more" and not "one and only one" unless specifically stated so. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter (e.g., her and its) and vice versa. Headings and subheadings, if any, are used merely for convenience and do not limit the invention.

[0048] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered at least equivalent.

[0049] As used herein, the phrase "at least one of," following a list of items, when followed by the word "or" separating any of those items, modifies the list as a whole and not each item in the list. The phrase "at least one of" does not require the selection of at least one item; rather, the phrase allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only, or any combination of A, B, and C.

[0050] The use of a phrase such as "aspect" does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. Disclosure of an aspect may apply to all configurations or one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may refer to one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. Disclosure of an embodiment may apply to all embodiments or one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may refer to one or more examples, and vice versa. A phrase such as "configuration" does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. Disclosure of a configuration may apply to all configurations or one or more configurations. A configuration may provide one or more examples. A phrase such as "a configuration" may refer to one or more configurations, and vice versa.

[0051] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, sizes, dimensions, and other specifications set forth herein, including those in the claims that follow, are approximate and not exact, and are intended to have a reasonable range consistent with the function to which they relate and the practice in the art to which they pertain.

[0052] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is an illustration of example approaches. Based on design preferences, it is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without user intervention. The accompanying method claims, if any, present elements of the various steps, operations, or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0053] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. No element of a claim is to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Moreover, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprise" would be interpreted when used as a transitional phrase in a claim.

[0054] The title, background art, summary, brief description of the drawings, and abstract of this disclosure are hereby incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description of the disclosure. This disclosure is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it will be appreciated that the description provides illustrative examples, and that various features have been grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the appended claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The appended claims are hereby incorporated into the detailed description, with each claim standing on its own as separately claimed subject matter.

[0055] The claims are not intended to be limited to the embodiments described herein, but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, and should not be construed, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. 1. A needleless access connector having a valve with an antimicrobial agent, the valve having a porous upper surface, the valve capable of compressing and collapsing when an axial force is applied to the porous upper surface and expanding and realigning when the axial force is removed, the valve including an insert within the valve near the porous upper surface of the valve, the insert having an antimicrobial coating thereon that includes the antimicrobial agent, whereby the antimicrobial agent can leach from the insert through the valve to an outer surface of the valve.

2. The needleless access connector of claim 1 , wherein the top surface of the valve comprises a silicone elastomer.

3. The needle-free access connector of claim 1 , wherein the insert has a flat upper surface near the porous upper surface of the valve.

4. The needleless access connector of claim 1 , wherein the insert has an upper surface that includes a plurality of pockets or clefts, and the antimicrobial coating is contained within the pockets or clefts.

5. The needleless access connector of claim 1 , wherein the insert is rigid and comprises a hard polymer material.

6. The needleless access connector of claim 1 , wherein the antimicrobial agent is contained in a coating formed from cyanoacrylate.

7. The needleless access connector of claim 1 , wherein the antimicrobial agent comprises a chlorhexidine salt.

8. 6. The needleless access connector of claim 1, wherein the antimicrobial agent is included in a coating on the valve, and the antimicrobial agent has a weight ratio of about 0.5 to about 50 parts per 100 parts of a formulation used to form the coating.

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