Needleless access connector with antibacterial valve

Abstract

A valve including an antimicrobial agent can be used with a needleless access connector. The valve can have an insert on which an antimicrobial coating is included, and / or the valve can have physical features that house an antimicrobial agent, such as a series of channels or grooves or a patterned surface, and / or the valve can be made of a material that includes an antimicrobial agent.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to needleless connectors, and more particularly to a needleless connector having an antimicrobial valve. BACKGROUND

[0002] Needleless access connectors (NACs) are widely used throughout the medical industry to connect and disconnect sources of medical fluid (e.g., saline solution or liquid medication) intended for infusion into a patient. Such connectors are often used with intravenous (IV) catheters that are connected to a fluid source, such as an IV bag, through an arrangement of flexible tubing and fittings, often referred to as an “IV set.”

[0003] Upon connection to a NAC, bacteria and other microorganisms can enter the patient’s vasculature from the access hub and port / valve. Each access hub (or port / valve or connection) is associated with some risk of catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0004] To reduce catheter-related bloodstream infection (CRBSI) events, and to ensure proper use and maintenance of the connectors, standards of practice have been developed that include disinfection and cleaning procedures. For example, the 2016 Infusion Nurses Society (INS) Guidelines recommend that a needleless connector should be continuously and thoroughly disinfected with alcohol, tincture of iodine, or chlorhexidine gluconate / alcohol combination prior to each access.

[0005] Disinfection of needleless connectors ultimately aims to help reduce bacteria that can live on surfaces and can cause various catheter-related complications, including the aforementioned CRBSI events. Nurses will often complete this disinfection task by performing a so-called “scrub of the hub” using a 70% IPA alcohol pad. However, compliance with this practice and its efficacy does not appear to be rigorous. Additionally, healthcare professionals tend to replace NAC connectors frequently, such as at least once a week, to reduce infection due to potential bacterial buildup. However, there is a continued need to reduce potential bacterial infection and to extend the useful life of needleless access connectors. SUMMARY

[0006] Aspects of the subject technology relate to needleless access connectors having valves that are capable of resisting bacterial growth, and more particularly to needleless access connectors having access ports with antimicrobial valves.

[0007] In some aspects, the NAC valve includes a head portion and a body portion extending distally from the head portion, the head portion having a top surface, wherein an antimicrobial agent is disposed on or in the valve. In other aspects, an insert is included in the valve, the insert including the antimicrobial agent. In further aspects, the valve is the only component in the needleless access connector that includes the antimicrobial agent.

[0008] Embodiments, alone or in combination, include one or more of the following features. For example, the valve (including its top surface) can include a silicone elastomer. In some embodiments, the valve can have a porous top surface and include an insert proximate the porous top surface of the valve, where the insert includes an antimicrobial coating thereon that includes an antimicrobial agent. Further, the insert can have a top surface that is flat and proximate the porous top surface of the valve. In other embodiments, the valve can have a series of channels or holes within the top surface of the valve, and the channels and / or holes house an antimicrobial formulation that includes an antimicrobial agent. Alternatively or additionally, the valve can have a series of grooves or texturized patterns that contain an antimicrobial formulation that includes an antimicrobial agent. Further, the valve can include a material that includes an antimicrobial agent, for example, the valve can include a silicone elastomer, a fluoropolymer, and an antimicrobial agent. In yet another embodiment, the valve material includes an antimicrobial agent by injection of an antimicrobial formulation into the top surface of the valve. In other embodiments, the antimicrobial formulation can be a sustained release antimicrobial formulation and can include a biodegradable polymer, a network-forming polymer, a temperature / pH sensitive polymer, or a combination thereof, or a polymer-forming component, such as a curable adhesive component. The antimicrobial agent can be contained in a coating on or in the valve, and the antimicrobial agent can be contained in about 0.5 to about 50 parts by weight relative to 100 parts by weight of a formulation used to form the coating.

[0009] Additional advantages of the subject technology will be apparent from the detailed description that follows, taken in conjunction with the accompanying drawings, which together illustrate, by way of example, certain aspects of the subject technology. As will be realized, the subject technology is capable of other and different BRIEF DESCRIPTION OF DRAWINGS

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

[0011] Figures 1A-1C is a view of an example needleless access connector. Figure 1A is a three-dimensional view showing components of a needleless access connector in unassembled form. Figure 1B and 1C are cross-sectional views of an assembled needleless access connector, showing closed and open states, respectively.

[0012] Figure 2A and 2Bis a view of an exemplary valve of a needleless access connector. Figure 2A A valve of a NAC is shown having an insert near the porous top surface of the valve. Figure 2B An insert having a top surface comprising a pocket or slit is shown.

[0013] Figure 3 An exemplary valve of a needleless access connector is shown having a physical feature on the top surface of the valve that can house an antimicrobial coating or formulation. DETAILED DESCRIPTION

[0014] 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 can be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, the descriptions set forth regarding certain aspects are not intended to be construed as limiting. It is apparent, however, to one skilled in the art that the subject technology can be practiced without such specific details. In some instances, well-known structures and components are shown in block diagram form, rather than in detail, in order to avoid obscuring the concepts of the subject technology.

[0015] It is to 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 will now be disclosed, in accordance with specific but non-limiting examples. The various embodiments described in this disclosure can be performed in different ways and variations and according to the desired application or implementation.

[0016] Aspects of the subject technology relate to needleless access connectors (NACs) having valves, e.g., valves made of silicone elastomer, that include an antimicrobial agent. In some aspects of the disclosure, the valve has an insert that includes an antimicrobial coating thereon that includes an antimicrobial agent, and / or a physical feature, such as a series of holes or grooves or a patterned surface, that houses an antimicrobial formulation that includes an antimicrobial agent, and / or the valve is made of a material that includes an antimicrobial agent.

[0017] Advantageously, but not exclusively, the valve is the only component of the needleless access connector that includes an antimicrobial agent. Needleless access connectors having valves that are the only component of the needleless access connector that includes an antimicrobial agent can reduce the amount of antibiotic available to medical fluid flowing through the connector, thereby reducing the antibiotic load of a patient using such a NAC. Reducing antibiotic load is particularly advantageous when more than one NAC is used to deliver fluid to a patient. In addition, valves that include a sustained release antimicrobial coating advantageously can extend the useful life of the NAC, thereby reducing the need to frequently replace the NAC over a given time period.

[0018] Figures 1A-1C An exemplary needleless access connector employing a valve is shown. Figure 1Ais a three-dimensional view showing the components of the needleless access connector 100 in unassembled form. Figure 1B and 1C is a cross-sectional view of the assembled needleless access connector 100, showing the closed and open states, respectively. As shown in this example, the needleless access connector 100 includes a housing 102 having a proximal end 104 defining an access port 114 of the housing 102 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 portion 106 or bottom of the housing 102 opposite the top access port 114.

[0019] The housing 102 includes an interior cavity 140 extending at least partially therebetween the proximal end 104 and the distal end 106. The needleless access connector 100 further includes a compressible valve 200 disposed within the interior 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 as having a notched configuration at the head portion, although notches are required to practice various aspects of the present disclosure.

[0020] The access port 114 can include an engagement feature 101 for coupling to another device (e.g., a fluid transfer assembly). For example, the engagement feature 101 can include mating mechanical elements such as internal or external threads, detents, bayonet-type locking elements, and other surface configurations such as tapered luer surfaces for frictional engagement. In some embodiments, the inlet port 114 can define a female luer fitting with luer lock threads 101. In some embodiments, the exit port 116 can include an engagement feature for coupling to another device or to an interconnecting tubing piece. For example, the exit port 116 can include a male luer taper and luer lock threads 103 for medical device instrument interconnection. However, the engagement feature of the exit port 116 can include other mating mechanical elements. In operation, for example, a fluid path can be established from the access port 112 to the exit port 108 through the needleless connector.

[0021] In operation, the compressible valve 200 of the needleless connector is capable of compressing and collapsing when an axial force is applied to the top surface 204 of the compressible valve 200, and is capable of expanding and realigning 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 interior cavity 130 of the housing 102, thereby allowing a fluid path from the access port 114 to the exit port 116. As shown in the example, the compressible valve 200 has a hollow member (e.g., a notched head portion 220) that is capable of collapsing and expanding. Figure 1C Figure 1C ​The male luer 160 (shown) can be connected to the access port 114 by the female connector 101. Insertion of the male luer 160 collapses the valve 200 down into the internal cavity 130 to break the seal between the head portion 220 of the valve 200 and open the fluid flow path 109 from the access port 114 to the exit port 116. Figure 1C The collapsible valve 200 is shown in the collapsed position after insertion of the male luer 160 into the female luer 101. The male luer 160 is delivering fluid, for example from an IV bag, that flows through the internal cavity 130, around the valve element 200, into the channel in the male luer connector 103, and into the catheter or female luer.

[0022] The housing 102 can comprise one or more rigid polymer materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic acid or acrylate, or combinations thereof. The valve 200, including the head portion 220 and the top surface 204, can comprise an elastomeric, inert material, such as a silicone elastomer, such that it is collapsible with the housing 102 and resistant to adverse interactions with medical fluids.

[0023] While current NAC designs are robust against bacterial intrusion, the access port is a particular concern because it is typically exposed to the environment when the access port is not connected to a medical device. However, with a NAC having a valve that includes an antimicrobial agent, particularly on the top surface of the valve (also referred to as the front side and access port side of the valve), the formation or buildup of bacteria can be minimized or eliminated, and these conditions can be maintained for an extended period of time, such as for use for a week or more. Thus, in aspects of the present disclosure, the NAC has a valve, such as a valve comprising a silicone elastomer, that includes an antimicrobial agent, such as through a sustained release antimicrobial coating or formulation on or within the valve.

[0024] In aspects of the present disclosure, an insert having an antimicrobial coating is included within the valve of the NAC. The insert can be contained near the top surface of the valve. Figure 2A and 2B An example needleless access connector is shown employing a valve having an insert. In such embodiments, the valve 300 includes a hole on the top surface 304 (e.g. porous top surface) of the head portion 320 of the valve 300, such that the antimicrobial agent is able to leach from the insert through the valve to the outer surface of the valve. Further, the porous top surface can also allow liquid (such as aqueous medical fluid, disinfecting fluid, or other fluid) to access the insert, thereby allowing aqueous antimicrobial agent (such as chlorhexidine salt) to leach from the insert and eradicate microorganisms.

[0025] In some embodiments, the insert can have a flat top (in theFigure 2A The insert can be placed such that the flat top is substantially parallel to the top porous surface of the head portion of the NAC valve (e.g., 304). Additionally, or alternatively, the insert can include a pocket or recess that can serve as a reservoir for an antimicrobial coating placed on the insert. Figure 2B An exemplary insert 360 is shown having a top surface that includes a pocket or recess (364) for containing an antimicrobial coating or formulation in the pocket or recess. For this example, the insert 360 is included in the head portion 320 of the valve, and the top of the valve will include a porous top surface (not shown). The pocket or recess of the insert can advantageously help retain the insert in place within the valve due to the grip of the overmolded valve material in and / or around the pocket or recess.

[0026] In certain embodiments of the present disclosure, the insert can be rigid and can include one or more rigid polymer materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene butadiene rubber (SBR), polyacrylic acid or acrylate, or combinations thereof. A rigid insert has the advantage that such an insert in the top portion of the valve can make the top surface of the valve more rigid and less conformable to an instrument (e.g., a syringe) connected to the access port, thereby facilitating a more consistent or wider flow path for fluid being transferred through the NAC.

[0027] In another aspect of the present disclosure, the valve of the NAC can have physical features, such as a series of channels or grooves or a patterned surface, to contain an antimicrobial formulation including an antimicrobial agent. For example, as shown Figure 3 The valve 400 of the NAC can have a series of channels or holes (450) within the top surface (404) of the valve, which can be made by molding the valve with such features. These channels and / or holes can be filled or otherwise contain an antimicrobial formulation including an antimicrobial agent, such as a salt of chlorhexidine formulated with an adhesive.

[0028] In another aspect of the present disclosure, the valve of the NAC can have a series of grooves on its surface. The grooves can be on the top surface of the head portion of the valve 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 formulation containing an antimicrobial agent, such as a salt of chlorhexidine formulated with an adhesive, thereby forming a valve having a series of grooves or textured pattern containing an antimicrobial formulation containing an antimicrobial agent. When the valve having an antimicrobial coating within or on the physical features is in contact with an aqueous fluid, the water-soluble antimicrobial agent contained in the coating can be released from the valve, thereby providing antimicrobial properties to the contacted fluid and surrounding surfaces.

[0029] In another aspect of the disclosure, the valve of the NAC can have one or more hydrophilic surfaces and an antimicrobial coating comprising an antimicrobial agent on the one or more hydrophilic surfaces.

[0030] As mentioned above, the valve of the NAC can comprise a head portion and a body portion. Such valves are typically made of inert materials, such as silicone elastomers. However, due to the relative inertness and flexibility required of the valve, it is challenging to attach a sustained release antimicrobial coating on such materials. To better incorporate antimicrobial agents into such valves, the surface of the valve can be modified.

[0031] Thus, in aspects of the disclosure, the surface of the valve is treated to make the surface more hydrophilic than the 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 surface of the valve with a plasma of oxygen, argon, or both. The surface can be made more hydrophilic by applying a primer to the surface of the valve, followed by an antimicrobial coating, such as a tacky antimicrobial formulation (UV-curable silicone adhesive: polyurethane acrylate curable adhesive formulation with CHA / CHG). Such primers are available from, for example, Henkel and Loctite companies.

[0032] Another method to help incorporate antimicrobial agents into the valve of the NAC is to roughen the surface of the valve to better attach an antimicrobial coating. In addition, the surface can be subjected to ionized bombardment of an antimicrobial agent, such as CHA, to modify the surface.

[0033] In another aspect of the disclosure, the valve of the NAC can comprise an antimicrobial agent as part of the valve material. Preferably, the antimicrobial agent is dispersed more or less uniformly in the valve material. One way to accomplish this is to compound the valve material, such as a silicone elastomer, with an antimicrobial agent. Other polymeric components can also be compounded with the valve material and the antimicrobial agent. Such polymeric components include, for example, inert materials, such as fluoropolymers, such as polytetrafluoroethylene (PTFE), hydrophilic polymers, such as polyvinylpyrrolidone (PVP). Hydrophilic polymers can have the advantage that they can be applied to a surface, such as when such materials are in contact with an aqueous fluid, the hydrophilic polymer has a tendency to apply to the surface, which can then be eluted with an antimicrobial agent.

[0034] Another way to incorporate an antimicrobial agent as part of the valve material is to mix a silicone elastomer with another silicone material that has a hydrophilic chain to form a valve with a hydrophilic surface.

[0035] Another method of including an antimicrobial agent as part of a valve material is to soak the valve in a solution containing the antimicrobial agent, thereby causing the valve to swell and the agent to penetrate into the material. For example, a valve comprised of a silicone elastomer can be submerged in a solution of an antimicrobial agent, such as a salt of chlorhexidine. The valve swells in the solution, causing some of the antimicrobial agent to penetrate into the valve material.

[0036] Another method of including an antimicrobial agent in a NAC valve is to inject an antimicrobial formulation into the top surface or port face of the valve, such as by using a hypodermic needle. Once the needle is inserted into the top surface of the valve, a mixture of chlorhexidine / adhesive is injected. The mixture continues to be injected even as the needle is being withdrawn, thereby filling the void left by the needle.

[0037] Useful antimicrobial agents that can be included in a valve of a NAC or in a formulation used to prepare an antimicrobial coating of the present disclosure include, for example, aldehydes, anilines, biguanides, silver element or compounds thereof, bisphenols, and quaternary ammonium compounds, and the like or combinations thereof. In particular, suitable antimicrobial agents of the present disclosure include, for example, triclosan, chlorhexidine salts, such as chlorhexidine gluconate (CHG), chlorhexidine acetate (CHA), chlorhexidine phosphonic acid salt, silver salts, chlorhexidine / sulfadiazine silver.

[0038] 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 formulation can include a polymer-forming component, such as a UV-curable monomer and / or oligomer. In some embodiments, the polymer component of the formed antimicrobial coating or formulation is such that they can release the antimicrobial agent over time, for example, a sustained release coating or formulation can release the antimicrobial agent over time, such as over a period of at least 7 days, 14 days, 21 days, and the like. The molecular weight of the polymer of the formed coating can be adjusted to control the release rate of the antimicrobial agent.

[0039] Useful polymers that can be included in a formulation used to prepare an antimicrobial coating of the present disclosure include, for example, biodegradable polymers, such as poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polyglycolide (PGL), polylactic acid (PLA), poly-3-hydroxybutyrate (PBH), polysaccharides, polyethylene glycol (PEG), polyethylene oxide (PEO), network-forming polymers such as cellulose acetate, temperature / pH sensitive polymers such as hyaluronic acid, poly(N-isopropylacrylamide) (NIPPam), and the like or copolymers and / or combinations thereof.

[0040] Useful polymeric forming components that can be included in the formulations used to prepare the sustained release antimicrobial coatings of the present disclosure include, for example, moisture or temperature curable adhesive components such as cyanoacrylates, UV curable adhesives such as polyurethane acrylate curable adhesives. The curable adhesive components can be formulated with one or more antimicrobial agents. The UV curable formulations can include combinations of urethane or polyester type oligomers with acrylate type functionality, acrylate type monomers and antimicrobial agents with optional photoinitiators, rheology modifiers and additives. The antimicrobial agents are preferably uniformly distributed throughout the coating matrix.

[0041] A variety of UV curable oligomers can be used with the formulations of the present disclosure. For example, the oligomers can be acrylated aliphatic polyurethanes, acrylated aromatic polyurethanes, acrylated polyesters, unsaturated polyesters, acrylated polyethers, acrylated acrylic resins and the like or combinations of the foregoing. The acrylated functionality can be mono-, di-, tri-, tetra-, penta- or hexa-functional.

[0042] As with the oligomers, a variety of monomers can be used in the formulations of the present disclosure. These monomers include, for example, 2-ethylhexyl acrylate, isooctyl acrylate, isobornyl acrylate, 1,6-hexanediol diacrylate, diethylene glycol diacrylate, triethylene glycol diacrylate, pentaerythritol tetraacrylate, pentaerythritol triacrylate, dimethoxyphenyl phenacyl hexyl acrylate, 1,6 hexanediol methacrylate and the like or combinations thereof.

[0043] To facilitate UV curing, the UV curable formulations can include sufficient and compatible photoinitiators. Such photoinitiators can be 1) monomolecular cleavage type such as benzoin ethers, phenones, benzoyl oximes and acyloxy phosphines and 2) hydrogen abstraction type such as Michler's ketone, thioxanthone, anthracene ketone, benzophenone, methyldiethanolamine, 2-n-butoxyethyl-4-(dimethylamino)benzoate and the like or combinations thereof. The UV curable formulations can be rapidly cured with ultraviolet light, for example, depending on the formulation and curing conditions, the cure can be completed in seconds or minutes. The sustained release coatings of the present disclosure are typically effective in a few minutes.

[0044] The antimicrobial agent can be included in the formulations of the present disclosure in an amount of about 0.5 parts by weight to about 50 parts by weight of the formulation used to form the coating, for example, in an amount of about 0.5 to about 30 parts by weight of the formulation, such as from about 1 part by weight to about 20 parts by weight, relative to 100 parts by weight of the formulation used to form the coating.

[0045] Some specific formulations that can be applied include, for example, a polyurethane acrylate adhesive or a cyanoacrylate adhesive with about 8 wt% CHA that can be applied to the surface of a NAC valve. Additionally, the surface of a valve of a NAC can be subjected to a primer treatment (such as a primer for silicone valves available from companies such as Henkel and Loctite), followed by application of a formulation including 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 so that an acrylate polyurethane adhesive formulation can be coated onto the silicone valve.

[0046] Formulations for making the sustained release coatings of the present disclosure can be prepared by mixing the antimicrobial agent with the polymer, with or without a solvent, to form a slurry or solution. As an alternative to mixing the antimicrobial agent with the polymer or a combination thereof, the antimicrobial agent can be mixed with the polymer-forming components to prepare a formulation for making a sustained release coating. The formulation can then be applied to the top surface by spraying, dipping, and / or rubbing the formulation onto the surface. For example, according to certain aspects of the present disclosure, a curable formulation for making a sustained release antimicrobial coating can be prepared by combining a polymer-forming component, such as cyanoacrylate, with about 8 wt% of an antimicrobial agent, for example, fine powder of CHA (the CHA can be milled to a small mesh / sieve size so that it can be mixed to form a uniformly distributed CHA in the formulation). The slurry can then be applied to a valve of a NAC.

[0047] It should be understood that any particular order or hierarchy of steps in methods disclosed is an example of illustrative methods. Based upon design or implementation preferences, it should be understood that a particular order or hierarchy of steps in a process can be rearranged, or that all illustrated steps can be performed. In some embodiments, any of the steps can be performed concurrently.

[0048] The present disclosure is presented to enable any person skilled in the art to practice the various aspects described herein. The present 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 can be applied to other aspects.

[0049] Elements involved in singular form are not intended to mean "one and only one" unless specifically stated, but rather "one or more." The term "some" refers to one or more unless specifically stated otherwise. Pronouns in the masculine (his) include the feminine and neuter gender (her and it) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the application.

[0050] 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 being superior or more advantageous than other aspects or designs. In one respect, the various alternative constructions and operations described herein may be considered at least equivalent.

[0051] As used herein, the phrase "at least one" preceding a series of items, separated by the term "or," modifies the listed items as a whole, not each item individually. The phrase "at least one" does not require the selection of at least one item; rather, it allows for the inclusion of at least one of any one item, and / or at least one of any combination of items, and / or at least one of each item. For example, the phrase "at least one of A, B, or C" could refer to: only A, only B, or only C; or any combination of A, B, and C.

[0052] A phrase, such as "aspect," does not imply that such an aspect is essential to the art, or that such an aspect applies to all constructions of the art. Disclosure relating to an aspect may apply to all constructions, or one or more constructions. An aspect may provide one or more examples. For example, the phrase "aspect" may refer to one or more aspects, and vice versa. A phrase, such as "embodiment," does not imply that such an embodiment is essential to the art, or that such an embodiment applies to all constructions of the art. Disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. The phrase "such embodiment" may refer to one or more embodiments, and vice versa. A phrase, such as "construction," does not imply that such a construction is essential to the art, or that such a construction applies to all constructions of the art. Disclosure relating to a construction may apply to all constructions, or one or more constructions. A construction may provide one or more examples. The phrase "such construction" may refer to one or more constructions, and vice versa.

[0053] In one respect, unless otherwise stated, all measurements, numerical values, ratings, positions, sizes, dimensions, and other specifications set forth in this specification, including in the following claims, are approximate, not precise. In another respect, they are intended to have a reasonable range that is consistent with the functions they address and with the conventions of the field to which they belong.

[0054] It is to be understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration. Based upon design preferences, it is understood that specific order or hierarchy of steps, operations or processes can be rearranged. Some of the steps, operations or processes can be performed simultaneously. Some or all of the steps, operations or processes can be performed automatically, without the intervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in the particular order disclosed herein. However, the steps, operations or processes can be rearranged in other orders that are still within the scope of the claims.

[0055] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether these disclosure is explicitly recited in the claims. No claim element is to be construed as a means plus function unless the element is expressly recited using the phrase "means for." Furthermore, to the extent that the term "comprising" is used in the detailed description and claims, such term is intended to be interpreted in the same manner as the term "including," such that it covers both situations where the recited element(s) are present and situations where the recited element(s) are not present.

[0056] The title, background, summary, brief description of drawings, and abstract of the disclosure are hereby incorporated into this disclosure and provided as illustrative examples of the disclosure and are not intended to be limiting in any way. As submitted now, it is understood that they will not be used to limit the scope or meaning of the claims. Furthermore, in the detailed description, it can be seen that the description provides illustrative examples and, for the purposes of brevity, various features can be grouped together or described in a single embodiment. The methods of the disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than are explicitly recited in each claim. Rather, as is reflected in the following claims, the inventive subject matter is directed to less than all of the features described in a single disclosed construction or operation. The following claims are hereby incorporated into the detailed description, wherein each claim independently represents a separately claimed subject matter.

[0057] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims, wherein connection to equivalent features is expressly incorporated- and all legal equivalents are intended to be covered. However, no claim is intended to invoke 35 U.S.C. § 101, 102 or 103 unless expressly recited in the claim.

Claims

1. A pinless connector having a valve comprising an antibacterial agent, wherein the valve has a porous top surface, the valve being compressible and collapsible when an axial force is applied to the porous top surface and being expandable and realignable when the axial force is removed, and wherein, The valve includes an insert within the valve and near the porous top surface of the valve, wherein the insert includes an antimicrobial coating thereon comprising an antimicrobial agent, such that the antimicrobial agent can leach from the insert through the valve to the outer surface of the valve.

2. The pinless connector according to claim 1, wherein, The top surface of the valve comprises a silicone elastomer.

3. The pinless connector according to claim 1, wherein, The insert has a flat top surface that is close to the porous top surface of the valve.

4. The pinless connector according to claim 1, wherein, The insert has a top surface including a recess or slit, and the antibacterial coating is contained in the recess or slit.

5. The pinless connector according to claim 1, wherein, The insert is rigid and comprises a rigid polymer material.

6. The pinless connector according to claim 1, wherein, The valve has a series of channels within its top surface, and the channels contain an antimicrobial agent comprising the antimicrobial agent.

7. The pinless connector according to claim 1, wherein, The valve has a textured pattern that accommodates an antimicrobial preparation including the antimicrobial agent.

8. The pinless connector according to claim 7, wherein, The textured pattern includes a series of grooves.

9. The pinless connector according to claim 1, wherein, The valve has an antimicrobial coating comprising the antimicrobial agent on its hydrophilic surface.

10. The pinless connector according to claim 1, wherein, The valve is made of a material containing an antibacterial agent.

11. The pinless connector according to claim 10, wherein, The valve is made of silicone elastomer, fluoropolymer, and the antibacterial agent.

12. The pinless connector according to claim 10, wherein, The valve material contains the antimicrobial agent by injecting the antimicrobial agent into the top surface of the valve.

13. The pinless connector according to claim 12, wherein, The antibacterial agent is a continuously releasing antibacterial agent.

14. The pinless connector according to claim 13, wherein, The sustained-release antimicrobial agents include biodegradable polymers, network-forming polymers, temperature / pH-sensitive polymers, or combinations thereof.

15. The pinless connector according to claim 1, wherein, The antibacterial agent is contained in a coating formed of cyanoacrylate.

16. The pinless connector according to claim 1, wherein, The antibacterial agent includes chlorhexidine salt.

17. The pinless connector according to claim 1, wherein, The antimicrobial agent is contained in a coating on the valve, and the antimicrobial agent comprises about 0.5 to about 50 parts by weight relative to 100 parts by weight of the formulation for forming the coating.

18. A pinless connector having a valve comprising an antimicrobial agent, wherein, The valve is the only component of the pinless connector that includes the antibacterial agent, and wherein the valve is compressible and collapses when an axial force is applied to the top surface and expands and realigns when the axial force is removed. The valve has a porous top surface and includes an insert adjacent to the porous top surface of the valve, wherein the insert includes an antimicrobial coating thereon, the antimicrobial coating comprising an antimicrobial agent.

19. The pinless connector according to claim 18, wherein, The antibacterial agent is contained only on the top surface of the valve.

20. The pinless connector according to claim 18, wherein, The antibacterial agent is contained in a coating formed of cyanoacrylate.

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