Antimicrobial coating extending performance of needleless connector

Abstract

To provide a needleless access connector having an access port and a sustained release antimicrobial coating only on a top surface of the access port.SOLUTION: A top surface of an access port can be defined by a top surface of a proximal end of a housing and a top surface of a head portion of a compressible valve disposed within an internal cavity of the housing. A sustained release antimicrobial coating is on: (i) the top surface of the proximal end of the housing, or (ii) the top surface of the head portion of the compressible valve, or (iii) the sustained release antimicrobial coating is only on both the top surface of the proximal end of the housing and the top surface of the head portion of the compressible valve.SELECTED DRAWING: Figure 1B

Description

[Technical Field]

[0001] The present disclosure relates generally to needleless connectors, and more particularly to needleless connectors having a sustained-release antimicrobial coating that extends the performance life of such connectors. [Background technology]

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

[0003] When connected to a NAC, bacteria and other microorganisms can enter the patient's vascular system through the access hub and port / valve. Each access hub (or port / valve, or connection) carries some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

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

[0005] Disinfection of needleless connectors is intended to ultimately help reduce bacteria that may survive on surfaces and potentially lead to various catheter-related complications, including the aforementioned CRBSI events. Nurses typically complete this disinfection process by using a 70% IPA alcohol pad and performing what is known as "scrubbing the hub." However, compliance with this practice and its effectiveness do not appear to be strict. Furthermore, healthcare professionals tend to replace NAC connectors frequently, e.g., at least weekly, to reduce infections resulting from potential bacterial buildup. Summary of the Invention [Problem to be solved by the invention]

[0006] However, there is a continuing need to reduce potential bacterial infections and extend the lifespan of needleless access connectors. [Means for solving the problem]

[0007] Aspects of the subject technology relate to a needleless access connector with an antimicrobial coating, and in particular to a needleless access connector having an access port and having a sustained-release antimicrobial coating on the top surface of the access port.

[0008] The needleless access connector can include an access port defined by a top surface of a proximal end of a housing and a top surface of a head of a compressible valve reciprocally disposed within an internal cavity of the housing. For example, the needleless access connector can include a housing and a compressible valve, where the housing has a proximal end defining the access port of the housing, a distal end including a base defining the outlet port of the housing, and an inner surface defining an internal cavity extending between the access and outlet ports; the compressible valve is disposed within the internal cavity and configured to contact at least a portion of the inner surface, and includes a head and a compressible body extending distally from the head. In certain embodiments of the present disclosure, the top surface of the proximal end of the housing and / or the top surface of the head of the valve are coated with a sustained-release antimicrobial coating, and / or the sustained-release antimicrobial coating is present on the inner surface of the internal cavity of the housing slightly below the top surface. In other aspects of the present disclosure, the sustained-release antimicrobial coating is present only on the top surface of the proximal end of the housing, and / or only on the top surface of the compressible valve head, and / or only slightly below the top surface on the inner surface of the internal cavity of the housing.

[0009] Each embodiment may include one or more of the following features, individually or in combination. For example, the top surface of the proximal end of the housing may include a chamfer, and the sustained-release antimicrobial coating may be deposited within the chamfer. In some embodiments, the housing may include polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic, or acrylate, or a combination thereof. In other embodiments, the top surface of the compressible valve head may include a silicone elastomer. In still other embodiments, the sustained-release antimicrobial coating may include a biodegradable polymer, a mesh-forming polymer, a temperature / pH-sensitive polymer, or a combination thereof, and in other embodiments, the sustained-release antimicrobial coating includes a chlorhexidine salt as the antimicrobial agent.

[0010] Further advantages of the subject technology will become readily apparent to those skilled in the art from the following detailed description. In the description, only certain aspects of the subject technology have been shown and described for purposes of illustration only. As will be understood, the subject technology is capable of other and different configurations, and its several details are capable of modification in various other respects without departing from the subject technology. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

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

[0012] [Figure 1A] 1 illustrates a needleless access connector having an access port according to some embodiments of the present disclosure. [Figure 1B] FIG. 1B is a perspective view of the needleless access connector of FIG. 1A. [Figure 2] 1A-1C illustrate an access port of a needleless access connector according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0013] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configuration in which the subject technology can be practiced. The detailed description includes specific details intended to provide a thorough understanding of the subject technology. Accordingly, dimensions are provided for certain embodiments as non-limiting examples. However, it will be apparent to those 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 to avoid obscuring the concepts of the subject technology.

[0014] It should be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology are disclosed herein according to certain non-limiting examples. The various embodiments described in this disclosure may be implemented in different ways and with variations according to a desired application or implementation.

[0015] Aspects of the subject technology relate to a needleless access connector (NAC) having an access port and a sustained-release antimicrobial coating on a top surface of the access port. The top surface of the access port of the NAC can be defined by (i) a top surface of the proximal end of the housing (which can extend to the inner surface of the internal cavity) and (ii) a top surface of a compressible valve head reciprocally disposed in the internal cavity of the housing. In certain embodiments of the present disclosure, the sustained-release antimicrobial coating is (i) present on the top surface of the proximal end of the housing and extends slightly below the access port, or (ii) present on the top surface of the compressible valve head, or (iii) present only on both the top surface of the proximal end of the housing and the top surface of the compressible valve head.

[0016] By coating only the top surface of the access port of the NAC, the amount of antibiotic used along with the flow of fluid through the connector is advantageously reduced, and therefore, using a NAC with an antimicrobial coating only on its top surface reduces the antibiotic burden on the patient. This reduced antibiotic burden is particularly advantageous when multiple NACs are used to deliver fluids to a patient. Furthermore, coating the top surface of the access port of the NAC with a sustained-release antimicrobial coating advantageously extends the life of the NAC, thereby reducing the need for frequent replacement of the NAC over a given period of time.

[0017] Referring to FIG. 1A, a perspective view of a needleless access connector having an access port is shown. FIG. 1B is a partial cutaway perspective view of the needleless access connector. As shown in FIGS. 1A and 1B, the needleless access connector 100 includes a housing 102 having a proximal end 104 and a distal end 106 that defines an exit port 108 of the housing 102. As referred to herein, proximal refers to a direction toward a top port face 114 of the housing 102, and distal refers to a direction toward a base 106 or bottom of the housing 102 opposite the top port face 114.

[0018] The housing 102 includes an inner surface 130 defining an internal cavity 133 extending at least partially between the proximal and distal ends 104, 106, respectively. The needleless access connector 100 also includes a compressible valve 200 disposed within the internal cavity 133 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 as having a notched configuration on the head and a ribbed configuration on the body, although neither the notches nor the ribs are required to implement various aspects of the present disclosure.

[0019] 1A and 1B, and further shown in FIG. 2, the access port 112 is defined by the top surface 114 of the proximal end 104 of the housing 102 and the top surface 204 of the head 220 of the compressible valve 200. In certain embodiments, the top surface 114 of the proximal end 104 of the housing 102 can include a chamfer 116 that contacts the head 220 of the compressible valve 200 when the valve is in a closed state. The top surface 114 of the proximal end 104 of the housing 102 and the top surface 204 of the head 220 of the compressible valve 200 can include a specific amount of a sustained-release antimicrobial coating. Applying an antimicrobial compound to coat the chamfer or crevices on the top surface of the NAC access port can help tailor a predetermined volume of coating on the top surface and, therefore, a predetermined amount of antimicrobial agent available at the access port. The predetermined depth of the chamfer or gap helps ensure that a certain amount of antimicrobial coating is evenly applied to the access port during manufacturing of the NAC, thus ensuring a consistent and predictable release rate of the manufactured NAC.

[0020] The compressible valve head forms a seal at or around the top surface 114 of the proximal end 104 of the housing 102, thereby preventing the ingress of substances. An additional benefit of including a chamfer 116 with a time-release antimicrobial coating on the top surface 114 is that it protects any open areas or areas of insufficient contact that may occur between the valve head 220 and the inner surface 130 of the internal cavity 133 when the valve is in the closed position. If bacteria are present in such areas, a coat of the time-release antimicrobial coating on the chamfer can eradicate the bacteria, thus protecting the interface between the valve and the inner surface 130 of the internal cavity 133 at and around the valve head.

[0021] In operation, when an axial force is applied to the top surface 204 of the compressible valve 200, the compressible valve 200 of the needleless connector is compressed and collapsed, and when the axial force is removed, the valve is able to expand and realign. Thus, when an axial force (F) is applied to the top surface 204 of the valve, the valve (200) is compressed within the internal cavity 133 of the housing 102, providing a fluid path from the access port 112 to the outlet port 108.

[0022] The access port 112 can include an engagement feature 140 for coupling to another device (e.g., a fluid transfer assembly). For example, the engagement feature 140 can include cooperating mechanical elements such as internal or external threads, detents, bayonet-type locking elements, and other surface configurations such as a tapered luer surface for frictional engagement. In some embodiments, the inlet port 112 can define a female luer fitting with luer lock threading 140. In some embodiments, the outlet port 108 can include an engagement feature for coupling to another device or for coupling to interconnect tubing. For example, the outlet port 108 can include a male luer taper fitting and luer lock threading (not shown) for medical device and instrument interconnection. However, the engagement feature of the outlet port 108 can include other cooperating mechanical elements. In operation, a fluid pathway can be established from the access port 112 to the outlet port 108, for example, through a needleless connector.

[0023] An additional benefit of including a time-release antimicrobial coating on the inner surface 130 of the internal cavity 133 slightly below the apex 114 is that such a coating may further prevent the entry of active bacteria into the NAC. The antimicrobial coating on the inner surface 130 of the internal cavity 133 does not extend beyond the internal tapered luer portion and is preferably out of the fluid path when the NAC is connected to other devices. In certain embodiments, the time-release antimicrobial coating is located about 4 mm or less below the apex 114 on the inner surface 130 of the internal cavity 133, such as less than about 3 mm, less than about 2 mm, or less than about 1 mm.

[0024] The housing 102, including the top surface 114, can comprise one or more rigid polymeric materials, such as polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic or acrylate, or combinations thereof. The valve 200, including the head 220 and the top surface 204, can comprise a resilient, inert material, such as a silicone elastomer, so that it can collapse within the housing 102 and prevent adverse interactions with the medicinal solution.

[0025] While current designs for NACs are robust in preventing bacterial entry, access ports are of particular concern because they are typically exposed to the surrounding environment when not connected to a medical device. However, a sustained-release antimicrobial coating on the top surface of the access port can minimize or eliminate bacterial development or proliferation and can maintain this state for one or two weeks or longer of use. Thus, in one embodiment of the present disclosure, a sustained-release antimicrobial coating is applied only to the top surface of the access port of the NAC.

[0026] Useful sustained-release antimicrobial coatings for the surface of an access port include those that are water-absorbable, flexible, and durable. Such coatings can be formed from formulations containing one or more antimicrobial agents containing one or more polymers. Alternatively, or in combination with one or more antimicrobial agents and polymers, the formulation can include polymer-forming components, such as ultraviolet-curable monomers and / or oligomers. The polymer components of the formed antimicrobial coating can release the antimicrobial agent over time, for example, 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.

[0027] Useful polymers that can be included in the formulation to prepare the antimicrobial coatings of the present disclosure include, for example, biodegradable polymers such as poly(lactic-co-glycolic acid) (PLGA), polycaprolactone (PCL), polyglycosides (PGL), polylactic acid (PLA), poly-3-hydroxybutyrate (PBH), polysaccharides, polyethylene glycol (PEG), polyethylene oxide (PEO), mesh-forming polymers such as cellulose acetate, hyaluronic acid, temperature / pH sensitive polymers such as poly(N-isopropylacrylamide) (NIPPam), or copolymers thereof and / or combinations thereof.

[0028] Useful polymer-forming components that can be included in formulations for preparing the sustained-release antimicrobial coatings of the present disclosure include, for example, ultraviolet-curable adhesives, such as urethane acrylate curable adhesives, or moisture- or temperature-curable adhesive components, such as cyanoacrylates. UV-curable formulations can include a combination of urethane- or polyester-type oligomers with acrylate-type functional groups, or acrylate-type monomers, as polymer-forming components containing the antimicrobial agent, optionally a photoinitiator, a rheology modifier, etc. Moisture- or temperature-curable adhesive components can include a combination of cyanoacrylates and the antimicrobial agent, optionally with an activator, a rheology modifier, etc. It is preferred that the antimicrobial agent be uniformly dispersed throughout the coating matrix.

[0029] A wide variety of UV-curable oligomers can be used with the formulations of the present disclosure. For example, the oligomer can be an acrylated aliphatic urethane, an acrylated aromatic urethane, an acrylated polyester, an unsaturated polyester, an acrylated polyether, an acrylated acrylic resin, or the like, or a combination of the above. The acrylated functional group can be monofunctional, difunctional, trifunctional, tetrafunctional, pentafunctional, or hexafunctional.

[0030] Similar to the oligomers, a wide variety of monomers can be used with the formulations of the present disclosure, including, for example, 2-ethylhexyl acrylate, isooctyl acrylate, isobornyl acrylate, 1,6-hexanediol diacrylate, diethylene glycol diacrylate, triethylene glycol diacrylate, pentaerythritol tetraacrylate, pentaerythritol triacrylate, dimethoxyphenylacetophenone hexylmethyl acrylate, 1,6 hexanediol dimethacrylate, and the like, or combinations thereof.

[0031] To facilitate UV curing, UV-curable formulations can include a suitable and compatible photoinitiator. Such photoinitiators can be 1) monomolecular cleavage-type photoinitiators, such as benzoin ethers, acetophenones, benzoyl oximes, and acylphosphine oxides, and 2) hydrogen abstraction-type photoinitiators, such as Michler's ketone, thioxanthone, anthraquinone, benzophenone, methyldiethanolamine, and 2-N-butoxyethyl-4-(dimethylamino)benzoate, or combinations thereof. UV-curable formulations can be rapidly cured with UV light, for example, completing the cure within seconds or minutes, depending on the formulation and curing conditions. The sustained-release coatings of the present disclosure generally take effect within minutes.

[0032] Useful antimicrobial agents that can be included in formulations for preparing sustained-release antimicrobial coatings of the present disclosure include, for example, aldehydes, anilides, biguanides, elemental silver or compounds thereof, bisphenols, and quaternary ammonium compounds, or combinations thereof. In particular, suitable antimicrobial agents that can be included in formulations for preparing sustained-release coatings of the present disclosure include, for example, triclosan, chlorhexidine salts such as chlorhexidine gluconate (CHG), chlorhexidine diacetate (CHA), and chlorhexidine phosphanilate, silver salts, and chlorhexidine / silver sulfadiazine. The antimicrobial agent can be included in the formulations of the present disclosure in an amount of about 0.5 to about 50 parts by weight, e.g., about 1 to about 20 parts by weight, or about 0.5 to about 30 parts by weight of the formulation, based on 100 parts by weight of the formulation used to form the coating.

[0033] Some specific formulations that can be used include, for example, a urethane acrylate adhesive containing 8% CHA, which can be applied to the top of the NAC housing and then cured to form a sustained-release antimicrobial coating on the top. The top surface of the valve for the NAC can be primed with a primer, such as silicone valve primers available from companies such as Henkel and Loctite, and then a cyanoacrylate formulation containing 8% CHA can be applied and cured to form a sustained-release antimicrobial coating on the valve. Silicone valves can be plasma-treated to make them more hydrophilic / wettable, or the valves can be etched so that the urethane acrylate adhesive formulation can be coated on top of them.

[0034] The formulation for preparing the sustained-release coating of the present disclosure can be prepared by mixing the antimicrobial agent with a polymer, with or without a solvent, to form a slurry or solution. Alternatively, or in combination with mixing the antimicrobial agent with a polymer, the formulation for preparing the sustained-release coating can be prepared by mixing the antimicrobial agent with a polymer-forming component. The formulation can then be applied to the top surface by spray coating, dip coating, and / or painting the formulation onto the surface. For example, a curable formulation for preparing a sustained-release antimicrobial coating according to certain embodiments of the present disclosure can be prepared by combining the polymer-forming component with about 8% by weight of an antimicrobial agent, such as fine powder of CHA (the CHA can be milled to a small mesh / pore size to ensure uniform dispersion of the CHA throughout the blend), to form a slurry. The slurry can then be applied to the top surface.

[0035] As previously mentioned, the NAC access port includes a compressible valve on top. Such valves are typically made from inert materials such as silicone elastomers. However, due to the relative inertness and flexibility required of the valve, it is difficult to attach a sustained-release antimicrobial coating to such materials. To better support the attachment of a sustained-release antimicrobial coating to the top surface of the compressible valve, the surface can be modified.

[0036] Thus, in one embodiment of the present disclosure, prior to applying a sustained-release antimicrobial coating to a valve surface, such as the top surface of a silicone elastomer valve, the valve surface is treated to render the surface more hydrophilic than an untreated surface. Such treatments can include, for example, treatment with an alcohol, such as isopropyl alcohol (IPA). The hydrophilicity of the surface can also be enhanced by treating the valve surface with oxygen, argon, or both plasmas, or by pulsed plasma, which can deposit one or more desired monomers onto the surface to sequentially form a hydrophilic surface. The surface can be modified by applying a primer to the valve surface followed by an adhesive formulation. Such primers are available from companies such as Henkel and Loctite.

[0037] Another method to facilitate the attachment of a sustained-release antimicrobial coating to the top surface of a compressible valve is to modify the surface by creating surface roughness to enhance adhesion. Additionally, the surface can be modified by ion bombardment with an antimicrobial agent, such as CHA. The top surface of the valve can also be coated with a polymeric material containing an antimicrobial agent, which acts as a sustained-release antimicrobial coating on the surface of the valve.

[0038] It is understood that the specific order or hierarchy of blocks in the disclosed process methods describes example approaches. Based on design or implementation choices, it is understood that the specific order or hierarchy of blocks in the processes can be rearranged, or all of the blocks shown can be performed. In some implementations, any of the blocks may be performed simultaneously.

[0039] This disclosure is provided to enable those skilled in the art to practice the various aspects described herein. While this disclosure provides various examples of the subject technology, the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0040] Reference to an element in the singular is intended to mean "one or more" and not "one" unless specifically stated otherwise. The term "some" refers to one or more unless specifically stated otherwise. Masculine pronouns (e.g., his) include feminine and neuter pronouns (e.g., her and its), and vice versa. Headings and subheadings, if present, are used for convenience only and are not intended to limit the invention.

[0041] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein are construed as at least equivalent.

[0042] As used herein, the phrase "at least one of" preceding a list of items, with the word "or" separating any of the items, modifies the entire list rather than each item in the list. The phrase "at least one" does not require the selection of at least one item, but rather allows for the inclusion of at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. For example, the phrase "at least one of A, B, or C" can refer to A only, B only, or C only; or any combination of A, B, and C.

[0043] The use of a phrase such as "aspect" does not imply that the aspect is essential to the subject technology or that the aspect applies to all configurations of the subject technology. Disclosure relating to an aspect may apply to all configurations, or to one or more configurations. An aspect may provide one or more examples. A phrase such as "aspect" may represent one or more aspects, and vice versa. A phrase such as "embodiment" does not imply that the embodiment is essential to the subject technology or that the embodiment applies to all configurations of the subject technology. Disclosure relating to an embodiment may apply to all embodiments, or to one or more examples. An embodiment may provide one or more examples. A phrase such as "embodiment" may represent one or more examples, and vice versa. A phrase such as "configuration" does not imply that the configuration is essential to the subject technology or that the configuration applies to all configurations of the subject technology. Disclosure relating to a configuration may apply to all configurations, or to one or more configurations. A configuration may provide one or more examples. A phrase such as a composition may refer to one or more compositions, and vice versa.

[0044] In one aspect, unless otherwise stated, all measurements, values, ratios, positions, dimensions, sizes, and other specifications set forth in this specification, including the claims that follow, are approximate and not precise, and are intended to have a reasonable range consistent with the functions to which they relate and those customary in the art to which they pertain.

[0045] It is understood that the specific order or hierarchy of steps, operations, or processes disclosed is a description of example approaches. It is understood that the specific order or hierarchy of steps, operations, or processes may be rearranged based on design preferences. Some of the steps, operations, or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically without user intervention. The accompanying method claims, if any, present various steps, operations, or process elements in a sample order and are not meant to be limited to the specific order or hierarchy presented.

[0046] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later become known to those skilled in the art are intended to be expressly incorporated herein by reference and encompassed by the claims. Furthermore, nothing disclosed herein is intended to be made available to the public, regardless of whether such disclosure is expressly recited in the claims. Claim elements are not to be construed under the provisions of 35 U.S.C. § 112(f) unless the element is expressly recited using the phrase "means for," or, in the case of a method claim, unless the element is recited using the phrase "step for." Furthermore, to the extent terms such as "include," "have," and the like are used, such terms are intended to be inclusive in the same manner as the term "comprise," as "comprise" is interpreted when used as a transitional phrase in a claim.

[0047] The title, background, summary, brief description of the drawings, and abstract of this disclosure are incorporated into this disclosure and are provided as illustrative examples of the disclosure, not as a limiting description. They are presented with the understanding that they will not be used to limit the scope or meaning of the claims. Furthermore, in the Detailed Description, illustrative examples are provided by way of explanation, and it can be appreciated that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed structure or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

[0048] The claims are not intended to be limited to the embodiments described herein but are to be accorded full scope consistent with the language of the claims and encompass all legal equivalents. Nevertheless, none of the claims are intended, and should not be construed, to encompass subject matter that does not satisfy the requirements of 35 U.S.C. §§ 101, 102, or 103.

Claims

1. A needleless access connector having an access port, the access port being defined by a top surface of a proximal end of a housing and a top surface of a head of a compressible valve reciprocally disposed within an internal cavity of the housing, the needleless access connector including a sustained-release antimicrobial coating only on the top surface of the proximal end of the housing and / or only on the top surface of the head of the compressible valve.

2. The needleless access connector of claim 1 , wherein the sustained-release antimicrobial coating is only on the top surface of the proximal end of the housing.

3. 10. The needleless access connector of claim 1, wherein the sustained-release antimicrobial coating is only on the top surface of the head of the compressible valve.

4. The needleless access connector of claim 1 , wherein the sustained-release antimicrobial coating is only on the top surface of the proximal end of the housing and the top surface of the head of the compressible valve.

5. 2. The needleless access connector of claim 1, wherein the housing comprises polycarbonate (PC), polyurethane (PU), polyvinyl chloride (PVC), styrene-butadiene rubber (SBR), polyacrylic or acrylate, or a combination thereof.

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

7. The needleless access connector of claim 1 , wherein the sustained-release antimicrobial coating comprises a biodegradable polymer, a mesh-forming polymer, a temperature / pH sensitive polymer, or a combination thereof.

8. 10. The needleless access connector of claim 1, wherein the sustained-release antimicrobial coating is prepared from an ultraviolet-curable formulation.

9. The needleless access connector of claim 8 , wherein the ultraviolet curable formulation comprises a urethane acrylate curable adhesive.

10. The needleless access connector of claim 1 , wherein the sustained-release antimicrobial coating includes a chlorhexidine salt as an antimicrobial agent.

11. 11. The needleless access connector of claim 10, wherein the sustained-release antimicrobial coating releases the antimicrobial agent for at least 14 days.

12. 7. The needleless access connector of claim 6, wherein the top surface of the head of the compressible valve is treated to be hydrophilic prior to forming the sustained-release antimicrobial coating on the surface of the valve.

13. 13. The needleless access connector of claim 12, wherein the top surface of the head of the compressible valve is treated with plasma prior to forming the sustained-release antimicrobial coating on the surface of the valve.

14. The needleless access connector of claim 1 , wherein the sustained-release antimicrobial coating is in the form of a cap on the top surface of the head of the compressible valve.

15. 1. A needleless access connector comprising a housing and a compressible valve, the housing having a proximal end defining an access port of the housing, a distal end including a base defining an exit port of the housing, and an inner surface defining an internal cavity extending between the access portion and the exit port; the compressible valve disposed within the internal cavity and configured to contact at least a portion of the inner surface, the compressible valve comprising a head and a compressible body extending distally from the head, a top surface of the proximal end of the housing coated with a sustained-release antimicrobial coating; a top surface of the compressible valve head being spaced apart from a top surface of the proximal end of the housing when the top surface of the compressible valve head is in contact with the housing in a closed state; The compressible valve is configured to collapse into the internal cavity upon application of an axial force along an axis extending between the access port and the outlet port, thereby providing a fluid path from the access port to the outlet port.

16. 16. The needleless access connector of claim 15, wherein the top surface of the proximal end of the housing includes a chamfer, and the sustained-release antimicrobial coating is attached to the chamfer.

17. 16. The needleless access connector of claim 15, further comprising the sustained release antimicrobial coating on the inner surface of the interior cavity of the housing slightly below the top surface.

18. 18. The needleless access connector of claim 17, wherein only the top surface on the interior surface of the housing is coated with the sustained-release antimicrobial coating.

19. 16. The needleless access connector of claim 15, wherein the sustained-release antimicrobial coating includes a chlorhexidine salt as an antimicrobial agent.

20. 16. The needleless access connector of claim 15, wherein the sustained-release antimicrobial coating releases the antimicrobial agent for at least 14 days.

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