Needleless access connector with antibacterial valve

Abstract

A valve including an antibacterial agent may be used with a needleless access connector. The valve may have an insert including an antibacterial coating thereon, and / or the valve may have physical features containing an antibacterial agent, such as a series of channels or grooves or patterned surfaces, and / or the valve may be made of a material including an antibacterial agent.

Description

[0001] This application is a divisional application of the application filed on February 4, 2021, with application number 2021800132761 (international application number PCT / US2021 / 016668) and entitled "Needleless Access Connector with Antibacterial Valve". Technical Field

[0002] This disclosure generally relates to pinless connectors, and more particularly to a pinless connector with an antibacterial valve. Background Technology

[0003] Needleless access connectors (NACs) are widely used throughout the healthcare industry for connecting and disconnecting sources of medical fluids (such as saline solutions or liquid medications) intended for infusion into patients. These connectors are typically used with intravenous (IV) catheters, which connect to fluid sources, such as IV bags, via an arrangement of flexible tubing and fittings (often referred to as an “IV kit”).

[0004] When connected to a NAC, bacteria and other microorganisms can enter the patient's vascular system from the access hub and port / valve. Each access hub (or port / valve or connector) is associated with some risk of catheter-associated bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0005] To reduce catheter-related bloodstream infection (CRBSI) events and ensure the proper use and maintenance of connectors, standard practices have been developed, including disinfection and cleaning procedures. For example, the 2016 Infusion Care Standards (INS) guidelines recommend that needleless connectors be continuously and thoroughly disinfected with alcohol, iodine, or a combination of chlorhexidine gluconate and alcohol before each insertion.

[0006] The ultimate goal of sterilizing needle-free connectors is to help reduce bacteria that can live on surfaces and potentially cause various catheter-related complications, including the aforementioned CRBSI event. Nurses typically perform this sterilization task using 70% IPA alcohol pads by performing what is known as a “scrub-and-wash” process. However, adherence to this practice and its effectiveness appears to be less than rigorous. Furthermore, healthcare professionals tend to change NAC connectors frequently, such as at least weekly, to reduce the risk of infection due to potential bacterial buildup. However, continuous efforts are needed to reduce potential bacterial infections and extend the lifespan of needle-free access connectors. Summary of the Invention

[0007] Various aspects of this subject matter relate to pinless access connectors with valves capable of resisting bacterial growth, and more particularly to pinless access connectors with access ports having antibacterial valves.

[0008] 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 multiple surfaces of the valve or within the valve. In other aspects, an insert is included within the valve, the insert comprising the antimicrobial agent. In a further aspect, the valve is the only component in the needleless access connector that includes an antimicrobial agent.

[0009] The embodiments individually or in combination include one or more of the following features. For example, a valve (including its top surface) may include a silicone elastomer. In some embodiments, the valve may have a porous top surface and include an insert adjacent to the porous top surface of the valve, wherein the insert includes an antimicrobial coating thereon comprising an antimicrobial agent. Furthermore, the insert may have a top surface that is flat and adjacent to the porous top surface of the valve. In other embodiments, the valve may have a series of channels or holes within the top surface of the valve, and the channels and / or holes may contain an antimicrobial preparation comprising an antimicrobial agent. Alternatively or additionally, the valve may have a series of grooves or textured patterns comprising an antimicrobial preparation comprising an antimicrobial agent. Furthermore, the valve may include a material comprising an antimicrobial agent; for example, the valve may include a silicone elastomer, a fluoropolymer, and an antimicrobial agent. In yet another embodiment, the valve material comprises an antimicrobial agent by injecting an antimicrobial preparation into the top surface of the valve. In other embodiments, the antimicrobial agent may be a sustained-release antimicrobial agent and may 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 may be included in a coating on or within the valve, and may comprise about 0.5 to about 50 parts by weight relative to 100 parts by weight of the formulation used to form the coating.

[0010] From the following detailed description, those skilled in the art will readily understand the additional advantages of the subject matter, wherein only certain aspects of the subject matter are shown and described by way of illustration only. As will be appreciated, the subject matter can have other and different constructions, and certain details thereof can be modified in various other ways, all without departing from the subject matter. Therefore, the accompanying drawings and descriptions are to be considered illustrative in nature, rather than limiting. Attached Figure Description

[0011] The accompanying drawings are included to provide a further understanding and are incorporated in and form part of this specification. The drawings illustrate the disclosed embodiments and, together with the description, serve to explain the principles of the disclosed embodiments. In the drawings:

[0012] Figure 1A-1C This is a view of an exemplary pinless connector. Figure 1AThis is a three-dimensional view showing the components of a pinless connector in its unassembled form. Figure 1B and 1C This is a cross-sectional view of the assembled pinless connector, showing the closed and open states.

[0013] Figure 2A and 2B This is a view of an exemplary valve with a pinless connector. Figure 2A The diagram shows a valve from NAC with an insert near the top surface of the valve's orifice. Figure 2B An insert with a top surface including a recess or slit is shown.

[0014] Figure 3 An exemplary valve with a needleless access connector is shown, which has physical features on its top surface that can accommodate an antimicrobial coating or preparation. Detailed Implementation

[0015] The detailed description below depicts various constructions of the subject matter and is not intended to represent the only construction that can be used to practice the subject matter. The detailed description includes specific details intended to provide a thorough understanding of the subject matter. Therefore, dimensions regarding certain aspects are provided as non-limiting examples. However, it will be clear to those skilled in the art that the subject matter can 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 matter.

[0016] It should be understood that this disclosure includes examples of the subject matter and does not limit the scope of the appended claims. Various aspects of the subject matter will now be disclosed based on specific, but not limiting, examples. The various embodiments described in this disclosure may be implemented in different ways and variations, and depending on the desired application or implementation.

[0017] This subject matter relates to needleless access connectors (NACs) with valves, such as valves made of silicone elastomers that include antimicrobial agents. In some aspects of this disclosure, the valve has an insert including an antimicrobial coating thereon comprising an antimicrobial agent, and / or physical features (such as a series of holes or grooves or a patterned surface) that accommodate an antimicrobial preparation comprising the antimicrobial agent, and / or the valve is made of a material comprising the antimicrobial agent.

[0018] Advantageously, but not exclusively, the valve is the only component of the needleless access connector that includes the antimicrobial agent. A needleless access connector with a valve (the valve being the only component of the needleless access connector that includes the antimicrobial agent) can reduce the amount of antibiotics available when medical fluid flows through the connector, thereby reducing the antibiotic load on patients using this NAC. This reduction in antibiotic load is particularly advantageous when fluids are delivered to patients using more than one NAC. Furthermore, the valve, including a continuously releasing antimicrobial coating, advantageously extends the lifespan of the NAC, thereby reducing the need for frequent NAC replacements within a given time period.

[0019] Figure 1A-1C An exemplary pinless access connector employing a valve is shown. Figure 1A This is a three-dimensional view showing the components of the unassembled pinless connector 100. Figure 1B and 1C This is a cross-sectional view of the assembled pinless connector 100, showing both the closed and open states. As illustrated in this example, the pinless 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 mentioned 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 to the top access port 114.

[0020] The housing 102 includes an internal cavity 140 that extends at least partially between the proximal end 104 and the distal end 106. The pinless 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 as having a notch in the head portion; however, a notch is required to implement various aspects of this disclosure.

[0021] Inlet port 114 may include engagement features 101 for coupling to another device, such as a fluid transport assembly. Engagement features 101 may include mating mechanical elements (e.g., internal or external surface threads, pawls, bayonet locking elements, etc.) and other surface features (e.g., tapered Luer surfaces for friction engagement). In some embodiments, inlet port 114 may define a female Luer connector with Luer locking threads 101. In some embodiments, outlet port 116 may include engagement features for coupling to another device or to an interconnected fitting. For example, outlet port 116 may include a male Luer tapered connector and Luer locking threads 103 for medical device interconnection. However, engagement features of outlet port 116 may include other mating mechanical elements. In operation, for example, a fluid path from inlet port 112 to outlet port 108 may be established via a needleless connector.

[0022] In operation, when an axial force is applied to the top surface 204 of the compressible valve 200, the needleless connector's compressible valve 200 is able to compress and collapse, and when the axial force is removed, the valve is able to expand and realign. Therefore, when an axial force (F) is applied to the top surface 204 of the valve, the valve (200) is compressed within the internal cavity 130 of the housing 102, thereby allowing a fluid path from the inlet port 114 to the outlet port 116. Figure 1C The example shown has a hollow component (such as...) Figure 1C The male Luer connector 160 (shown) can be connected to the inlet port 114 via the female connector 101. The insertion of the male Luer connector 160 causes the valve 200 to collapse downward into the internal cavity 130, thereby breaking the seal between the valve 200 and the head portion 220, and opening the fluid flow path 109 from the inlet port 114 to the outlet port 116. Figure 1C A collapsible valve 200 is shown in a collapsed position after the male Luer 160 is inserted into the female Luer 101. The male Luer 160 delivers fluid, for example, from an IV bag, which flows through an internal cavity 130, around the valve element 200, into a passage in the male Luer connector 103, and into a conduit or female Luer.

[0023] The housing 102 may 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. The valve 200, including the head portion 220 and the top surface 204, may include an elastic, inert material (such as a silicone elastomer) such that it is collapsible within the housing 102 and resists adverse interactions with medical fluids.

[0024] 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 not connected to a medical device. However, NACs with valves containing antimicrobial agents, especially on the top surface of the valve (also known as the front side and access port side), can minimize or eliminate bacterial formation or accumulation, and these conditions can be maintained for an extended period, such as for use over a week or more. Therefore, in this disclosure, the NAC has a valve, such as a valve comprising a silicone elastomer, that includes an antimicrobial agent, for example, through the continuous release of an antimicrobial coating or formulation onto or within the valve.

[0025] In this disclosure, an insert with an antimicrobial coating is included within the valve of the NAC. The insert may be contained near the top surface of the valve. Figure 2A and 2B An exemplary pinless connector employing a valve with an insert is shown. In such an embodiment, the valve 300 includes holes on the top surface 304 (e.g., a porous top surface) of the head portion 320 of the valve 300, allowing an antimicrobial agent to leach from the insert through the valve to the outer surface of the valve. Furthermore, the porous top surface also allows liquids (such as aqueous medical fluids, disinfectant fluids, or other fluids) to approach the insert, thereby allowing an aqueous antimicrobial agent (such as chlorhexidine salt) to leach from the insert and eradicate microorganisms.

[0026] In some embodiments, the insert may have a flat top (in) Figure 2A Depicted as 352), and positioned such that the flat top is substantially parallel to the top porous surface (e.g., 304) of the head portion of the NAC valve. Alternatively, the insert may include recesses or slits that can serve as reservoirs for an antimicrobial coating placed on the insert. Figure 2B An exemplary insert 360 with a top surface is shown, which includes a recess or slit (364) for receiving an antimicrobial coating or formulation within the recess or slit. In this example, the insert 360 is included in the head portion 320 of a valve, and the top of the valve will include a porous top surface (not shown). The recess or slit of the insert can advantageously help retain the insert in place within the valve due to the gripping of the overmolded valve material in and / or around the recess or slit.

[0027] In some embodiments of this disclosure, the insert may be rigid and may comprise one or more rigid polymer 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 at the top portion of the valve can make the top surface of the valve more rigid and less likely to conform to instruments (e.g., syringes) connected to the access port, thereby facilitating a coherent or wider flow path for fluid transmitted via the NAC.

[0028] In another aspect of this disclosure, the valve of the NAC may have physical features, such as a series of channels or grooves or patterned surfaces, to accommodate an antimicrobial agent comprising an antimicrobial agent. For example, as Figure 3 As shown, the NAC valve 400 may have a series of channels or holes (450) within its top surface (404), which can be manufactured by molding a valve with this feature. These channels and / or holes may be filled or otherwise contained with antimicrobial agents, such as chlorhexidine salts formulated with an adhesive.

[0029] In another aspect of this disclosure, the valve of NAC may have a series of grooves on its surface. The grooves may be on the top surface of the valve's head portion and / or on the valve's body surface. These grooves may be formed as micropatterns and / or textured surfaces of the valve. These grooves / micropatterns may be molded into the part. The grooves may then be filled with an antimicrobial agent containing an antimicrobial agent (such as chlorhexidine salt formulated with an adhesive), thereby forming a valve with a series of grooves or textured patterns containing the antimicrobial agent. When a valve with an antimicrobial coating within or on a physical feature comes into contact with an aqueous fluid, the water-soluble antimicrobial agent contained in the coating may be released from the valve, thereby providing antimicrobial properties to the contacting fluid and surrounding surfaces.

[0030] In another aspect of this disclosure, the valve of NAC may have one or more hydrophilic surfaces and an antimicrobial coating comprising an antimicrobial agent on one or more hydrophilic surfaces.

[0031] As described above, NAC valves can include 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 by the valve, attaching a continuously releasing antimicrobial coating to this material is challenging. To better contain the antimicrobial agent, the surface of the valve can be modified.

[0032] Therefore, in this disclosure, the valve surface is treated to make it more hydrophilic than an untreated surface. This treatment may include, for example, treatment with an alcohol (such as isopropanol (IPA)). Treating the valve surface with plasma of oxygen, argon, or both can also make the surface more hydrophilic. The surface can be made more hydrophilic by applying a primer to the valve surface followed by an antimicrobial coating, such as an adhesive antimicrobial agent (UV-curable silicone adhesive: a curable polyurethane acrylate adhesive formulation with CHA / CHG). Such primers are available from companies such as Henkel and Loctite.

[0033] Another method that helps incorporate antimicrobial agents into NAC valves is to roughen the valve surface to improve the adhesion of the antimicrobial coating. Additionally, the surface can be subjected to ionization bombardment with antimicrobial agents such as CHA to modify the surface.

[0034] In another aspect of this disclosure, the valve of the NAC may include an antimicrobial agent as part of the valve material. Preferably, the antimicrobial agent is more or less uniformly dispersed in the valve material. One way to achieve this is to composite the valve material (e.g., a silicone elastomer) with the antimicrobial agent. Other polymeric components may also be composited with the valve material and the antimicrobial agent. Such polymeric components include, for example, inert materials, such as fluoropolymers, such as polytetrafluoroethylene (PTFE), and hydrophilic polymers, such as polyvinylpyrrolidone (PVP). Hydrophilic polymers can have the advantage that they can be applied to surfaces, for example, when such a material comes into contact with an aqueous fluid, the hydrophilic polymer has a tendency to apply to the surface, which can then be used to elute the antimicrobial agent.

[0035] Another method of incorporating antibacterial agents as part of the valve material is to mix a silicone elastomer with another silicone material having hydrophilic chains to form a valve with a hydrophilic surface.

[0036] Another method of incorporating antimicrobial agents as part of the valve material is to use the valve to absorb a solution containing the antimicrobial agent, thereby causing the valve to expand and allowing the reagent to permeate into the material. For example, a valve made of silicone elastomer can be immersed in a solution of antimicrobial agent, such as chlorhexidine salt. The valve expands in the solution, allowing some of the antimicrobial agent to permeate into the valve material.

[0037] Another method for incorporating antimicrobial agents into NAC valves is to inject the antimicrobial agent into the top surface or port face of the valve, for example, by using a hypodermic needle. Once the needle is inserted into the top surface of the valve, a mixture of chlorhexidine and adhesive is injected. Even as the needle is withdrawn, the mixture continues to be injected, filling the void left by the needle.

[0038] Useful antimicrobial agents that can be included in the valve of the NAC or in the formulation for preparing the antimicrobial coating of this disclosure include, for example, aldehydes, anilines, biguanides, silver elements or compounds thereof, bisphenols and quaternary ammonium compounds, or combinations thereof. Specifically, suitable antimicrobial agents of this disclosure include, for example, triclosan, chlorhexidine salts, such as chlorhexidine gluconate (CHG), chlorhexidine acetate (CHA), chlorhexidine phosphononitrile, silver salts, and chlorhexidine / silver sulfadiazine.

[0039] The useful antimicrobial coatings or formulations disclosed herein comprise one or more antimicrobial agents having one or more polymers. Alternatively, or in combination with one or more antimicrobial agents and polymers, the formulation may comprise polymer-forming components, such as UV-curable monomers and / or oligomers. In some embodiments, the polymer components of the formed antimicrobial coating or formulation are such that they can release antimicrobial agents over time, for example, a continuously releasing coating or formulation can release antimicrobial agents over time, such as over a period of 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.

[0040] Useful polymers that may be included in formulations for preparing the antimicrobial coatings of this disclosure include, for example, biodegradable polymers such as poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polyglycolic acid (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), etc., or copolymers thereof and / or combinations thereof.

[0041] Useful polymer-forming components that can be included in formulations for preparing the sustained-release antimicrobial coatings of this disclosure include, for example, moisture- or temperature-curable adhesive components (such as cyanoacrylates) and UV-curable adhesives (such as polyurethane acrylate-curable adhesives). The curable adhesive component can be formulated with one or more antimicrobial agents. UV-curable formulations may include a combination of urethane or polyester oligomers having acrylate functional groups, acrylate monomers, and antimicrobial agents with optional photoinitiators, rheology modifiers, and additives. The antimicrobial agent is preferably uniformly distributed throughout the coating matrix.

[0042] Various UV-curable oligomers can be used with the formulations disclosed herein. For example, the oligomers may be acrylated aliphatic polyurethanes, acrylated aromatic polyurethanes, acrylated polyesters, unsaturated polyesters, acrylated polyethers, acrylated acrylic resins, or combinations thereof. The acrylated functional groups may be monofunctional, difunctional, trifunctional, tetrafunctional, pentafunctional, or hexafunctional.

[0043] Similar to oligomers, a variety of monomers can be used in the formulations disclosed herein. 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, dimethoxyphenylacetophenone hexyl acrylate, 1,6-hexanediol methacrylate, and combinations thereof.

[0044] To facilitate UV curing, UV-curable formulations may include sufficient and compatible photoinitiators. Such photoinitiators may be: 1) unimolecular cleavage type, such as benzoyl ether, acetophenone, benzoyl oxime, and phosphine oxide; and 2) hydrogen-abstract type, such as mifepristone, thioxanthone, anthrone, benzophenone, methyl diethanolamine, 2-n-butoxyethyl-4-(dimethylamino)benzoate, etc., or combinations thereof. UV-curable formulations can be rapidly cured with ultraviolet light; for example, depending on the formulation and curing conditions, curing can be completed within seconds or minutes. The sustained-release coatings of this disclosure are typically effective within minutes.

[0045] The antimicrobial agent may be included in the formulation disclosed herein in an amount of about 0.5 parts by weight to about 50 parts by weight relative to 100 parts by weight of the formulation for forming the coating, for example, in an amount of about 0.5 to about 30 parts by weight, such as from about 1 part by weight to about 20 parts by weight.

[0046] Some specific formulations that can be applied include, for example, polyurethane acrylate adhesives or cyanoacrylate adhesives containing approximately 8 wt% CHA, which can be applied to the surface of NAC valves. Additionally, the surface of the NAC valve can undergo a primer treatment (such as primers for silicone valves available from companies like Henkel and Loctite), followed by the application of a formulation containing 8% CHA and curing of the formulation to form a continuously releasing antimicrobial coating on the valve. Silicone valves can be made more hydrophilic / wettable through plasma treatment, or the valve can be etched to allow the acrylate polyurethane adhesive formulation to be coated onto the silicone valve.

[0047] Formulations for preparing the sustained-release coatings of this disclosure can be prepared by mixing an antimicrobial agent with a polymer, with or without a solvent, to form a slurry or solution. Alternatively, the antimicrobial agent can be mixed with a polymer forming component to prepare a formulation for preparing the sustained-release coating. The formulation can then be applied to a top surface by spraying, dipping, and / or wiping the surface. For example, according to certain aspects of this disclosure, a curable formulation for preparing a sustained-release antimicrobial coating can be prepared by combining a polymer forming component (e.g., cyanoacrylate) with about 8 wt% of an antimicrobial agent (e.g., fine powder of CHA (CHA can be ground to a small mesh / pore size so that it can be mixed to form a uniformly distributed CHA in the formulation)) to form a slurry. The slurry can then be applied to a valve of an NAC.

[0048] It should be understood that any particular order or hierarchy of the boxes in the disclosed process is illustrative of the exemplary method. Based on design or implementation preferences, it should be understood that a particular order or hierarchy of the boxes in the process may be rearranged, or all shown boxes may be executed. In some implementations, any boxes may be executed simultaneously.

[0049] 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 matter, and the subject matter is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the general principles defined herein can be applied to other aspects.

[0050] Unless otherwise specified, elements involving the singular form are not intended to mean "one and only one," but rather "one or more." Unless otherwise specified, the term "some" refers to one or more. Masculine pronouns (such as his) include feminine and neuter pronouns (such as her and its), and vice versa. Titles and subtitles, if any, are used for convenience only and do not limit the invention.

[0051] 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.

[0052] 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.

[0053] 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.

[0054] 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.

[0055] It should be understood that the specific order or hierarchy of the disclosed steps, operations, or processes is an illustration of an exemplary method. Based on design preferences, it should be understood that the specific order or hierarchy of steps, operations, or processes can be rearranged. Some steps, operations, or processes can be performed simultaneously. Some or all steps, operations, or processes can be performed automatically without user intervention. The appended method claims (if any) present elements of various steps, operations, or processes in an exemplary order and are not intended to limit one to the specific order or hierarchy presented.

[0056] All structural and functional equivalents of elements throughout the various aspects described in this disclosure, known or to be known by one of ordinary skill in the art, are expressly incorporated herein by reference and are intended to be covered by the claims. Furthermore, regardless of whether such disclosure is expressly stated in the claims, the contents of this disclosure are not intended for public use. No element of a claim is construed under 35 USC §112(f) unless the phrase “means for…” is used to expressly state an element of the claim, or, in the case of a method claim, the phrase “steps for…” is used to state an element of the claim. Furthermore, with regard to the scope of terms such as “comprising,” “having,” etc., such terms are intended to refer to openness in a manner similar to the term “including,” as interpreted when “comprising” is used as a transitional word in a claim.

[0057] The title, background, overview, drawings, brief description, and abstract of this disclosure are incorporated herein by reference and are provided as illustrative examples rather than as limiting descriptions. It should be understood upon filing this application that they are not intended to limit the scope or meaning of the claims. Furthermore, as will be apparent from the detailed description, which provides illustrative examples, various features are combined in various embodiments for the purpose of simplification. The methods of this disclosure should not be construed as reflecting an intention that the claimed subject matter requires more features than expressly stated in each claim. Rather, as reflected in the following claims, the subject matter of the invention lies in fewer than all features of a single disclosed construction or operation. The following claims are thus incorporated into the detailed description, each claim being an independent, separately claimed subject matter.

[0058] The claims are not intended to be limited to the aspects described herein, but rather to conform to the full scope consistent with the language claims and to cover all legal equivalents. Nevertheless, none of the claims are intended to include subject matter that fails to meet the requirements of 35 U.S.SC § 101, 102, or 103, nor should they be interpreted in this manner.

Claims

1. A pinless connector having a valve comprising an antimicrobial agent, wherein, The valve has a porous top surface that includes the antibacterial agent.

2. The pinless connector according to claim 1, wherein, The top surface of the valve includes a silicone elastomer, which includes the antibacterial agent.

3. 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.

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

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

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

7. The pinless connector according to claim 6, wherein, The valve material includes a silicone elastomer, a fluoropolymer, and the antibacterial agent.

8. The pinless connector according to claim 6, wherein, The valve material contains the antimicrobial agent by injecting the antimicrobial agent into the top surface of the valve.

9. 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.

10. A pinless connector having a valve comprising an antimicrobial agent, wherein, The valve has a porous top surface that includes the antimicrobial agent, and wherein the valve is the only component of the needleless access connector that includes the antimicrobial agent.

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