Needle-free access connector with antimicrobial-resistant valve

Abstract

To provide needleless access connectors having a valve that can resist bacterial growth, and in particular, needleless access connectors having access ports with an antimicrobial resistant valve.SOLUTION: A valve including an antimicrobial agent can be used with needleless access connectors. The valve can have an insert that includes an antimicrobial coating thereon, and / or the valve can have physical features, such as a series of tunnels or groves or a patterned surface, containing an antimicrobial formulation, and / or the valve can be made of a material that includes an antimicrobial agent.SELECTED DRAWING: Figure 2A

Description

Technical Field

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

Background Art

[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 equipment having a flexible tube and fittings commonly referred to as an "intravenous (IV) set."

[0003] When connecting to a NAC, there is a potential for bacteria and other microorganisms to 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 transferring a catheter related bloodstream infection (CRBSI), which can be potentially fatal at great cost.

[0004] To reduce catheter related bloodstream infection (CRBSI) incidents and to ensure that connectors are properly used and maintained, practice standards have evolved and include disinfection and cleaning techniques. For example, the 2016 Infusion Nurses Standard (INS) Guidelines encourage that needleless connectors should always be thoroughly disinfected using alcohol, povidone iodine, or a chlorhexidine gluconate / alcohol formulation prior to each access.

[0005] The disinfection of needle-free connectors is fundamentally intended to help reduce bacteria that can inhabit the surface and potentially cause a variety of catheter-related complications, including the aforementioned CRBSI events. Nurses typically complete this disinfection process by using 70% IPA alcohol pads, a practice known as "scrubbing the hub." However, compliance with this practice and its effectiveness are not considered stringent. Furthermore, to reduce infections resulting from bacterial growth, healthcare workers tend to change NAC connectors frequently, for example, at least weekly. However, there is a continuing need to reduce the possibility of bacterial infection and extend the service life of needle-free access connectors. [Overview of the project]

[0006] An aspect of the subject art relates to a needleless access connector having a valve capable of resisting bacterial growth, and more specifically, to a needleless access connector having an access port having an antimicrobial-resistant valve.

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

[0008] The embodiments include one or more of the following features individually or in combination. For example, the valve may have a silicone elastomer, including its upper surface. In some embodiments, the valve may have a porous upper surface, and an insert may be included near the porous upper surface of the valve, the insert having an antimicrobial coating containing an antimicrobial agent on the insert. Furthermore, the insert may have a flat upper surface that is located near the porous upper surface of the valve. In other embodiments, the valve may have a series of tunnels or bores within the upper surface of the valve, the tunnels and / or bores containing an antimicrobial formulation containing an antimicrobial agent. Alternatively or additionally, the valve may have a series of grooves or texture patterns that contain an antimicrobial formulation containing an antimicrobial agent. Furthermore, the valve may have a material containing an antimicrobial agent, for example, the valve may have a silicone elastomer, a fluoropolymer and an antimicrobial agent. In even further embodiments, the valve material may contain an antimicrobial agent by injecting the antimicrobial formulation into the upper surface of the valve. In other embodiments, the antimicrobial formulation may be a sustained-release antimicrobial formulation and may include a biodegradable polymer, a mesh-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 contained in the coating on or inside the valve, and the amount of the antimicrobial agent may be 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 art will be readily apparent to those skilled in the art from the detailed description below, and only specific embodiments of the subject art are shown and described merely as examples. As will be understood, the subject art is capable of other different configurations, and some of its details are modifiable in various other ways, all without departing from the scope of the subject art. Therefore, the drawings and description should be considered illustrative and not limiting in nature.

[0010] To provide further understanding, the accompanying drawings, which are included and incorporated into this specification and constitute part thereof, illustrate the disclosed embodiments and, together with the description, help to illustrate the principles of the disclosed embodiments. [Brief explanation of the drawing]

[0011] [Figure 1A] This is a diagram of an example of a useless access connector, a three-dimensional diagram showing the components of a useless access connector in an unassembled state. [Figure 1B] This is a diagram of an example of a useless access connector, a broken view of an assembled useless access connector showing it in the closed position. [Figure 1C] This is a diagram of an example of a useless access connector, a broken view of an assembled useless access connector showing it in the open position. [Figure 2A] This is a diagram of an example valve for a non-accessible connector, showing a valve for a NAC with an insert near the porous upper surface of the valve. [Figure 2B] This is a diagram of an example valve for a non-accessible connector, showing an insert with a top surface including a pocket or slit. [Figure 3] This diagram shows an example of a valve for an unwanted access connector, which has a physical mechanism on its upper surface that can accommodate an antimicrobial coating or compound. [Modes for carrying out the invention]

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

[0013] This disclosure includes examples of the subject art and should not be understood as limiting the scope of the appended claims. Here, various aspects of the subject art are disclosed in accordance with specific, but non-limiting, examples. The various embodiments described herein may be carried out in different ways and variations according to the desired use or practice.

[0014] Aspects of the subject art relate to needle-free access connectors (NACs) having valves, for example, valves made from silicone elastomers having an antimicrobial agent. In some embodiments of the present disclosure, the valve has a physical mechanism such as a series of tunnels or grooves or patterned surfaces that house an insert having an antimicrobial coating containing an antimicrobial agent, and / or an antimicrobial formulation containing an antimicrobial agent, and / or the valve is made from a material containing an antimicrobial agent.

[0015] Conveniently, though not exclusively, the valve is the only component of the needle-free access connector that contains an antimicrobial agent. A needle-free access connector having a valve, which is the only component of the needle-free access connector that contains an antimicrobial agent, can reduce the amount of antibiotic available along with the flow of medical fluid through the connector, and therefore can reduce the administration of antibiotics to the patient using NACs, etc. Reducing antibiotic administration is particularly advantageous when fluid is delivered to the patient using two or more NACs. Furthermore, a valve containing a sustained-release antimicrobial coating can conveniently reduce the need for frequent replacement of NACs over a given period of time by extending the service life of the NACs.

[0016] An example of a needleless access connector using a valve is shown in Figures 1A and 1C. Figure 1A is a three-dimensional view showing the components of the needleless access connector 100 in an unassembled state. Figures 1B and 1C are broken views 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, which has 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 orientation of the housing 102 toward the upper access port 114, and distal refers to the orientation of the housing 102 toward the base portion 106 or the lower side, opposite the upper access port 114.

[0017] The housing 102 includes an internal cavity 140 that extends at least partially between a proximal end 104 and a distal end 106. The needleless access connector 100 also includes a compressible valve 200 located within the internal cavity 140 of the housing 102. The compressible valve 200 includes a head 220 and a compressible body 230 extending distally from the head 220. In this example, the compressible valve is shown having a notched configuration on the head, but these notches are required to practice various aspects of the present disclosure.

[0018] The access port 114 may include an engagement mechanism 101 for connecting to another device (e.g., a fluid transfer assembly). For example, the engagement mechanism 101 may include cooperating mechanical elements such as internal or external threads, detents, bayonet-type locking elements, and other surface configurations such as tapered Luer surfaces for friction engagement. In some embodiments, the inlet port 114 may define a female Luer that mates with a Luer-lock thread 101. In some embodiments, the outlet port 116 may include an engagement mechanism for connecting to another device or to an interconnecting tube. For example, the outlet port 116 may have a male Luer-tapered fitting and a Luer-lock thread 103 for interconnecting medical device instruments. However, the engagement mechanism of the outlet port 116 may include other cooperating mechanical elements. During operation, a fluid path may be established, for example, from the inlet port 112 to the outlet port 108 via a needleless connector.

[0019] During operation, the compressible valve 200 of the needleless connector can be compressed and collapsed when an axial force is applied to the upper surface 204 of the compressible valve 200, and the valve can be expanded and repositioned when the axial force is removed. Thus, when an axial force (F) is applied to the upper surface 204 of the valve, the valve (200) compresses within the internal cavity 130 of the housing 102, thereby enabling a fluid path from the access port 114 to the outlet port 116. As in the example shown in Figure 1C, a male Luer connector 160 having a hollow member (as shown in Figure 1C) can be connected to the access port 114 via a female connector 101. Insertion of the male Luer connector 160 causes the valve 200 to collapse downward into the internal cavity 130, breaking the seal between the head 220 of the valve 200 and the internal cavity 130, and opening a fluid flow path 109 from the access port 114 to the outlet port 116. Figure 1C shows the collapsible valve 200 in the collapse 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 may have one or more rigid polymer materials such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic acid or acrylate, or a combination thereof. The valve 200, including the head 220 and the top surface 204, may have an elastic-inert material such as silicone elastomer, so that the valve can be crushed within the housing 102 and is prevented from interacting with the medicinal fluid in the opposite direction.

[0021] While the current design of the NAC is robust enough to prevent bacterial invasion, the access ports are of particular concern because they are generally exposed to the environment when not connected to a medical device. However, in particular, a NAC having a valve with an antibacterial agent on the upper surface of the valve, also referred to as the face side and the access port side of the valve, can minimize or eliminate bacterial formation or growth, and these conditions can be maintained over an extended time period, for example, during use for more than a week. Thus, in one aspect of the present disclosure, the NAC has a valve, for example, a valve having a silicone elastomer containing an antibacterial agent such as a sustained-release antibacterial coating or formulation on or in the valve.

[0022] In one aspect of the present disclosure, an insert having an antibacterial coating is contained within the valve of the NAC. The insert can be contained near the upper surface of the valve. An example of a needleless access connector using a valve having an insert is shown in FIGS. 2A and 2B. In such an embodiment, the valve 300 includes holes in its upper surface 304 (e.g., a porous upper surface) of the head 320 of the valve 300, so that the antibacterial agent can exude from the insert through the valve to the outer surface of the valve. Further, the porous upper surface also allows a liquid such as a medical fluid to enter the insert, sterilize the fluid or other fluid, and allow an antibacterial agent solution, for example, chlorhexidine salt, to exude from the insert and eradicate microorganisms.

[0023] In some embodiments, the insert may have a flat top (shown as 352 in Figure 2A) and be positioned such that this flat top is substantially parallel to the porous top surface (e.g., 304) of the head of the NAC valve. Furthermore or alternatively, the insert may include a pocket or crevice that can act as a reservoir for the antimicrobial coating to be placed inside. Figure 2B shows an example insert 360 having a top surface including a pocket or crevice (364) for housing the antimicrobial coating or formulation within the pocket or crevice. In 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 crevice of the insert can conveniently facilitate the retention of the insert in place within the valve by gripping the valve material overmolded within and / or around the pocket or crevice.

[0024] In certain embodiments of the present disclosure, the insert may be rigid and may have one or more rigid polymer materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic acid or acrylate, or a combination thereof. A rigid insert has the advantage that such an insert in the upper portion of the valve makes the upper surface of the valve more rigid and less prone to deformation around instruments connected to the access port, such as syringes, thereby facilitating a consistent or wider flow path for the fluid delivered through the NAC.

[0025] In another aspect of the present disclosure, the valve of the NAC can have a physical mechanism such as a series of tunnels or grooves or a patterned surface that houses an antibacterial formulation containing an antibacterial agent. For example, as shown in FIG. 3, the valve 400 of the NAC can have a series of tunnels or bores 450 in the upper surface (404) of the valve, and these tunnels or bores can be created by molding a valve having such a mechanism. These tunnels and / or bores can contain an antibacterial formulation containing an antibacterial agent, such as chlorhexidine salt formulated with an adhesive, by filling or other means.

[0026] 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 upper surface at the head of the valve and / or on the body surface of the valve. Such grooves can be formed as a micro-pattern and / or a textured surface of the valve. Such grooves / micro-patterns can be molded within the component. The grooves can then be filled with an antibacterial formulation containing an antibacterial agent, such as chlorhexidine salt formulated with an adhesive, resulting in a valve having a series of grooves or textured patterns that house an antibacterial formulation containing an antibacterial agent. When a valve having an antibacterial coating on or within a physical mechanism comes into contact with a fluid liquid, the water-soluble antibacterial agent contained in the coating is released from the valve, thereby imparting antibacterial properties to the contacting fluid and the surrounding surfaces.

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

[0028] As described above, the valve of the NAC can include a head and a body. Such valves are generally made from an inert material such as a silicone elastomer. However, adhering a sustained-release antibacterial coating to such a material is challenging due to its relative inertness and the flexibility required for the valve. To better contain an antibacterial agent with such a valve, the surface of the valve can be modified.

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

[0030] Another way to facilitate the incorporation of antimicrobial agents into NAC valves is to roughen the valve surface for better adhesion of the antimicrobial coating. Furthermore, the surface can undergo ionization collisions of antimicrobial agents, such as CHA, to modify the surface.

[0031] In another aspect of this disclosure, the NAC valve may include an antimicrobial agent as part of the valve material. Preferably, the antimicrobial agent is diffused approximately uniformly within the valve material. One way to achieve this is to mix the valve material, e.g., a silicone elastomer, with the antimicrobial agent. Other polymer compounds can also be mixed with the valve material and the antimicrobial agent. Such polymer 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 of being able to spread on the surface when such materials come into contact with a fluid, and hydrophilic polymers tend to spread on the surface, and then can elute the antimicrobial agent.

[0032] Another way to incorporate an antimicrobial agent 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.

[0033] Another way to incorporate an antimicrobial agent as part of the valve material is to immerse the valve in a solution containing the antimicrobial agent, thereby causing the valve to expand and allowing the antimicrobial agent to penetrate the valve material. For example, a valve made of silicone elastomer can be immersed in a solution of an antimicrobial agent such as chlorhexidine salt. The valve expands in the solution, allowing some of the antimicrobial agent to permeate the valve material.

[0034] Another method of introducing antimicrobial agents into the NAC valve is to inject an antimicrobial compound into the upper or port surface of the valve, for example, by using a subcutaneous injection needle. When the needle is inserted into the upper surface of the valve, a chlorhexidine / adhesive mixture is injected. This mixture continues to be injected even after the needle is withdrawn, filling the void left by the needle.

[0035] Useful antimicrobial agents that may be included in the valve of the NAC or in the formulation for preparing the antimicrobial coating of this disclosure include, for example, aldehydes, anilides, biguanides, silver elements or compounds thereof, bisphenols, and quaternary ammonium compounds, or combinations thereof. In particular, suitable antimicrobial agents of this disclosure include, for example, triclosan, chlorhexidine salts such as chlorhexidine gluconate (CHG), chlorhexidine acetate (CHA), and chlorhexidine phosphanilate, silver salts, and chlorhexidine / sulfadiazine silver.

[0036] The useful antimicrobial coatings or formulations of this disclosure comprise one or more antimicrobial agents having one or more polymers. Alternatively, or in combination with one or more antimicrobial agents and polymers, the formulations may include polymers that form components, such as UV-curable monomers and / or oligomers. In some examples, the polymer components of the formed antimicrobial coating or formulation are capable of releasing the antimicrobial agent over time, for example, a sustained-release coating or formulation that releases the antimicrobial agent over time such as at least 7 days, 14 days, 21 days, etc. The molecular weight of the polymers in the formed coating may be adjusted to control the rate of antimicrobial agent release.

[0037] Useful polymers that may be included in formulations for preparing the antimicrobial coatings of this disclosure include, for example, biodegradable polymers such as polylactic-glycolic acid copolymer (PLGA), polycaprolactone (PCL), polyglycolide (PGL), polylactic acid (PLA), poly-3-hydroxybutyrate (PBH), polysaccharide, polyethylene glycol (PEG), polyethylene oxide (PEO), mesh-forming polymers such as cellulose acetate, temperature / pH-sensitive polymers such as hyaluronic acid, poly(isopropylacrylamide) (NIPPam:(N-Isopropylacrylamide), or copolymers thereof and / or combinations thereof.

[0038] Useful polymer-forming components that may be included in formulations for preparing the sustained-release antimicrobial coatings of this disclosure include, for example, moisture-curing or temperature-curing adhesive components such as cyanoacrylates, and UV-curing adhesives such as urethane-acrylate-curing adhesives. The curing adhesive components may contain one or more antimicrobial agents. UV-curing formulations may include combinations of urethane or polyester oligomers having acrylate-type functional groups, acrylate-type monomers, and antimicrobial agents with optional photoinitiators, rheology modifiers, and additives. The antimicrobial agents are preferably uniformly distributed throughout the coating matrix.

[0039] A wide variety of UV-curable oligomers can be used with the formulations of this disclosure. For example, the oligomers may be acrylated aliphatic urethanes, acrylated aromatic urethanes, acrylated polyesters, unsaturated polyesters, acrylated polyethers, acrylated acrylics, or combinations thereof. The acrylated functional groups may be monofunctional, difunctional, trifunctional, tetrafunctional, pentafunctional, or hexafunctional.

[0040] As with oligomers, a wide variety of monomers can be used with the formulations of this disclosure. Such monomers include, 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 methacrylic acid, or combinations thereof.

[0041] To facilitate UV curing, UV-curable formulations may contain a suitable photoinitiator. Such photoinitiators may be 1) monomolecular cleavage types such as benzoin ether, acetophenone, benzoyl oxime, and acyl phosphine oxides, and 2) hydrogen abstraction types such as Michler's ketone, thioxanthone, anthrogionone, benzophenone, methyldiethanolamine, 2-N-butoxyethyl 1-4-(dimethylamino)benzoate, or combinations thereof. UV-curable formulations can be rapidly cured, for example, by ultraviolet light, and curing may be achieved in seconds or minutes depending on the formulation and curing conditions. The sustained-release coatings of this disclosure generally become effective within minutes.

[0042] The antimicrobial agent may be included in the formulation of the present disclosure in an amount of about 0.5 to about 50 parts by weight per 100 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 about 1 to about 20 parts by weight.

[0043] Some specific formulations that can be applied include, for example, a urethane-acrylate adhesive or cyanoacrylate adhesive having about 8 wt% CHA that can be applied to the surface of the NAC valve. Furthermore, a primer, such as a primer for silicone valves, available from companies such as Henkel and Loctite, can be applied to the surface of the NAC valve, and then a formulation containing 8% CHA can be applied and cured to form a sustained-release antimicrobial coating on the valve. The silicone valve can be made more hydrophilic / wettable by plasma treatment, or the valve can be etched so that the acrylate-urethane adhesive formulation can be coated onto the silicone valve.

[0044] The formulations for preparing the sustained-release coatings of this disclosure may be prepared by mixing an antimicrobial agent with a polymer, with or without a solvent, to form a slurry or solution. Alternatively, or in combination therewith, the antimicrobial agent may be mixed with a polymer-forming component to prepare a formulation for preparing a sustained-release coating. The formulation may 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 a particular aspect of this disclosure may be prepared by combining a polymer-forming component, such as cyanoacrylate, with about 8 wt% of a fine powder of an antimicrobial agent, such as CHA (the CHA may be ground to a fine mesh / pore size so that it can be mixed to form a uniform distribution of CHA in the formulation) to form a slurry. The slurry may then be applied to the valve of the NAC.

[0045] Any particular order or hierarchy of blocks in the disclosed process method is to be understood as an example of an exemplary approach. It is understood that, based on design or implementation priorities, the steps, the particular order or hierarchy of blocks in the process may be rearranged, or all of the indicated blocks 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 embodiments described herein. This disclosure provides various examples of the subject art, and the subject art is not limited to these examples. Various modifications to these embodiments will be readily apparent to a person skilled in the art, and the general principles defined herein may be applied to other embodiments.

[0047] References to singular elements are intended to mean "one or more" and not "one and just one" unless specifically stated otherwise. The term "several" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and her), and vice versa. Headings and subheadings, where present, are used merely for convenience and do not limit the invention.

[0048] The term “exemplary” is used herein to mean “serving as an example or illustration.” An embodiment or design described herein as “exemplary” is not necessarily construed as being preferable or advantageous to other embodiments or designs. In one embodiment, 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 set of items, when accompanied by the term “or” to separate any of those items, modifies the enumerated set as a whole, rather than each of the enumerated items. The phrase “at least one of” does not require the selection of at least one item; rather, it allows the meaning to include 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. For example, the phrase “at least one of A, B, or C” could refer to A only, B only, or C only, or any combination of A, B, and C.

[0050] The terms "aspects," etc., do not imply that such aspects are essential to the subject art, nor that such aspects apply to all configurations of the subject art. Disclosures relating to aspects may apply to all configurations or one or more configurations. Aspects may provide one or more examples. The terms "aspects," etc., may refer to one or more aspects, and vice versa. The terms "examples," etc., do not imply that such examples are essential to the subject art, nor that such examples apply to all configurations of the subject art. Disclosures relating to examples may apply to all examples or one or more examples. Examples may provide one or more examples. The terms "examples," etc., may refer to one or more examples, and vice versa. The terms "configuration," etc., do not imply that such configurations are essential to the subject art, nor that such configurations apply to all configurations of the subject art. Disclosures relating to configurations may apply to all configurations, or one or more configurations. Configurations may provide one or more examples. The terms "composition," etc., may refer to one or more compositions, and vice versa.

[0051] In one embodiment, unless otherwise stated, all measurements, values, ratings, locations, sizes, dimensions, and other specifications described herein, including those in the following claims, are approximate and not precise. In one embodiment, they are intended to be within a reasonable range that is not inconsistent with the functions to which they relate and the conventions of the art to which they belong.

[0052] It is understood that any specific sequence or hierarchy of steps, actions, or processes disclosed are illustrative examples of an exemplary approach. It is understood that any specific sequence or hierarchy of steps, actions, or processes may be rearranged based on design priorities. Some of the steps, actions, or processes may be performed simultaneously. Some or all of the steps, actions, or processes may be performed automatically without user intervention. Where there are attached method claims, they present various elements of steps, actions, or processes in a sample sequence and are not intended to limit the present sequence or hierarchy.

[0053] All structural and functional equivalents to elements of various forms described throughout this disclosure, whether known to those skilled in the art or to be known thereafter, are incorporated herein by express reference and intended to be encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, whether such disclosure is expressly contained in the claims or not. No element of a claim should be construed under Section 112(f) of the United States Patent Act unless it is expressly described using the phrase “means for” or, in the case of a method claim, the phrase “step for.” Moreover, wherever terms such as “include” and “have” are used, such terms are intended to be as comprehensive as the term “comprise” is used, as “comprise” is construed when it is used as a transitional clause in a claim.

[0054] The Title of the Invention, Background Art, Summary of the Invention, Brief Description of the Drawings, and Abstract of the Invention are thereby incorporated into the Disclosure and provided as exemplary examples of the Disclosure, not as an exclusive description of the Disclosure. The Disclosure is filed with the understanding that these are not to be used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, it is found that the Description provides exemplary examples and that various features are grouped together in various embodiments for the purpose of streaming the Disclosure. The methods of the Disclosure should not be construed as indicating an intention that the claimed subject matter requires more features than expressly described in each claim. Rather, as the attached claims indicate, the subject matter of the Invention has fewer features than all the features of a single disclosed configuration or operation. The attached claims are thus incorporated into the Detailed Description, and each claim is based on itself as separately claimed subject matter.

[0055] The claims are not intended to be limited to the embodiments described herein, but should be given a complete scope consistent with the language of the claims and encompass all legal equivalents. However, none of the claims are intended, nor should they be construed, to encompass subject matter that does not meet the requirements of Section 101, 102, or 103 of the U.S. Patent Act.

[0056] The following examples of various aspects of this disclosure are described below as clauses numbered (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the scope of the technologies covered. [Clause 1] Needle-free access connector with a valve containing an antimicrobial agent. [Clause 2] The needle-free access connector according to Clause 1, wherein the upper surface of the valve is made of silicone elastomer. [Clause 3] The needle-free access connector according to Clause 1, wherein the valve has a porous upper surface and includes an insert near the porous upper surface of the valve, the insert having an antimicrobial coating thereon comprising the antimicrobial agent. [Clause 4] The insert has a flat top surface near the porous top surface of the valve, as described in Clause 3, for the needle-free access connector. [Clause 5] The needle-free access connector according to Clause 3, wherein the insert has a top surface comprising a plurality of pockets or cracks, and the antimicrobial coating is contained within the pockets or cracks. [Clause 6] The insert is a rigid and rigid polymer material, as described in Clause 3, for the needleless access connector. [Clause 7] The needle-free access connector according to Clause 1, wherein the valve has a series of tunnels or bores within the upper surface of the valve, and the tunnels and / or bores contain an antimicrobial compound comprising the antimicrobial agent. [Clause 8] The valve has a series of grooves or texture patterns for housing an antimicrobial compound containing the antimicrobial agent, as described in Clause 1, for the needle-free access connector. [Clause 9] The valve is a needle-free access connector according to Clause 1, wherein the valve has an antimicrobial coating containing the antimicrobial agent on the hydrophilic surface of the valve. [Clause 10] The valve is made of a material containing the antimicrobial agent, as described in Clause 1, for the needle-free access connector. [Clause 11] The valve material comprises a silicone elastomer, a fluoropolymer, and the antimicrobial agent, as described in Clause 10, for the needle-free access connector. [Article 12] The valve material comprises the antimicrobial agent by injecting the antimicrobial compound into the upper surface of the valve, as described in Clause 10, for a needle-free access connector. [Clause 13] The aforementioned antimicrobial compound is a sustained-release antimicrobial compound, as described in Clause 12, for the needle-free access connector. [Clause 14] The needle-free access connector according to Clause 13, wherein the sustained-release antimicrobial compound comprises a biodegradable polymer, a mesh-forming polymer, a temperature / pH-sensitive polymer, or a combination thereof. [Article 15] The needle-free access connector according to Clause 1, wherein the antimicrobial agent is contained in a coating formed from cyanoacrylate. [Clause 16] The antimicrobial agent is a chlorhexidine salt, as described in Clause 1 of the needle-free access connector. [Article 17] The needle-free access connector according to Clause 1, wherein the antimicrobial agent is contained in a coating on the valve, and the antimicrobial agent is present in an amount of about 0.5 to about 50 parts by weight relative to 100 parts by weight of the formulation used to form the coating. [Clause 18] A needle-free access connector having a valve containing an antimicrobial agent, wherein the valve is the only component of the needle-free access connector containing the antimicrobial agent. [Article 19] The needle-free access connector according to Clause 18, wherein only the upper surface of the valve contains the antimicrobial agent. [Clause 20] The needle-free access connector according to Clause 18, wherein the antimicrobial agent is contained in a coating formed from cyanoacrylate.

Claims

1. Needle-free access connector having a valve containing an antimicrobial agent, wherein the valve has a series of tunnels or bores within the upper surface of the valve, the tunnels and / or bores containing an antimicrobial compound comprising the antimicrobial agent, and the valve further includes an insert within the valve near the upper surface of the valve, the insert having an antimicrobial coating thereon on which the antimicrobial agent is contained, so that the antimicrobial agent can seep from the insert through the valve to the outer surface of the valve.

2. Needle-free access connector having a valve containing an antimicrobial agent, wherein the valve has a series of grooves or texture patterns for containing an antimicrobial compound comprising the antimicrobial agent, and the valve further includes an insert within the valve near the upper surface of the valve, the insert having an antimicrobial coating thereon on which the antimicrobial agent is contained, so that the antimicrobial agent can seep from the insert through the valve to the outer surface of the valve.

3. Needle-free access connector having a valve having an antimicrobial agent, wherein the valve has an antimicrobial coating containing the antimicrobial agent on its hydrophilic surface, and the valve further includes an insert within the valve near the upper surface of the valve, the insert having an antimicrobial coating containing the antimicrobial agent on it, so that the antimicrobial agent can seep from the insert through the valve to the outer surface of the valve.

4. Needle-free access connector having a valve having an antimicrobial agent, wherein the valve is made of a material containing the antimicrobial agent, the valve further includes an insert within the valve near the upper surface of the valve, the insert has an antimicrobial coating thereon on which the antimicrobial agent can seep from the insert through the valve to the outer surface of the valve.

5. The needle-free access connector according to claim 4, wherein the valve material comprises a silicone elastomer, a fluoropolymer, and the antimicrobial agent.

6. The needle-free access connector according to claim 4, wherein the valve material contains the antibacterial agent by injecting the antibacterial compound onto the upper surface of the valve.

7. The needle-free access connector according to claim 6, wherein the antimicrobial compound is a sustained-release antimicrobial compound.

8. The needle-free access connector according to claim 7, wherein the sustained-release antimicrobial compound comprises a biodegradable polymer, a mesh-forming polymer, a temperature / pH-sensitive polymer, or a combination thereof.

9. The needle-free access connector according to any one of claims 1 to 7, wherein the antimicrobial agent is contained in a coating formed from cyanoacrylate.

10. The needle-free access connector according to any one of claims 1 to 7, wherein the antimicrobial agent comprises a chlorhexidine salt.

11. The needle-free access connector according to any one of claims 1 to 7, wherein the antimicrobial agent is contained in the coating on the valve, and the amount of the antimicrobial agent is about 0.5 to about 50 parts by weight relative to 100 parts by weight of the compound used to form the coating.

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