Self-aligning universal cap for male and female luer connectors

Abstract

A universal cap for connection to a medical connector facilitates easier alignment and engagement of the cap with a threaded male or female Luer medical connector and enhances connector disinfection. A split collar projection projects axially from the closed end wall of the cap toward the open bottom and includes at least one pair of opposed parallel fan-shaped chuck fingers / forks terminating at a projection end. The inner wall of each chuck finger defines a split flange cantilever, respectively. The inner wall and the outer wall of each collet finger define a split thread, each of which is dimensioned to mate with a respective corresponding thread mating of a Luer connector. An antibacterial agent infused absorbent material is oriented between the split flange and the cap bottom. When the cap is attached to the Luer connector, the absorbent material compresses the offset split flange and deflects the collet finger / fork to more easily align and engage the cap with the Luer medical connector and enhance connector disinfection.

Description

Technical Field

[0001] The present disclosure generally relates to a device for disinfecting and sterilizing access ports having, for example, male and / or female Luer fittings, and more particularly to a disinfecting and sterilizing device capable of accommodating multiple types of Luer connectors. Exemplary embodiments of the present disclosure generally relate to the field of threaded fittings, including medical caps and medical sterilization caps, and more particularly to universal medical caps and / or sterilization caps for use with either or both male and female fluid Luer connectors. Background Art

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general categories of VADs: peripheral catheters and central venous catheters. When connected to a VAD to deliver fluids or pharmaceuticals, bacteria and other microorganisms can enter the patient's vascular system through the access hub and ports / valves. Each access hub (port / valve or connection) is associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which are costly and potentially fatal.

[0003] To reduce cases of CRBSI and ensure proper use and maintenance of VADs, standards of practice have been developed that include disinfection and cleaning procedures.

[0004] Sterile caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that caps will also be incorporated into the 2016 Infusion Nurses Standards (INS) guidelines.

[0005] In developed markets, when IV catheters are used, a needleless connector is typically used to close the system and is then accessed to administer medication or other necessary fluids to the patient via the catheter. The INS practice standards recommend the use of needleless connectors and stipulate that they should be "consistently and thoroughly disinfected using alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that can survive on surfaces and can cause various catheter-related complications, including CRBSI. Nurses will typically use a 70% isopropyl alcohol (IPA) pad to accomplish this disinfection task using a so-called "scrub hub." However, compliance with this practice is typically low. In addition to non-compliance with the "scrub hub" regulations, interviews with clinicians also noted that there is often variation in scrub times, drying times, and the number of times needleless connectors are scrubbed.

[0006] Throughout the procedural sequence, there are numerous risks of exposure or contamination associated with the transmission of microorganisms that could lead to CRBSI. Contamination can occur during medication mixing, cannula attachment, and insertion into the access hub. Because the process of connecting to a VAD is so common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risk to hospitals and patients depends substantially on the diligence of the clinician performing the connection and is largely uncontrollable.

[0007] Currently, caps for male and female needleless connectors, intravenous (IV) and hemodialysis lines use different designs and are therefore limited to the types of connectors to which the caps can be attached. Currently, there are male sterilization cap devices for sterilizing ISO 594-2 female threaded fluid Luer connectors, and there are female sterilization cap devices for sterilizing ISO 594-2 male threaded fluid Luer connectors. Therefore, existing sterilization caps are designed to fit only one type of connector and are specific to a connector of a specific size and / or shape.

[0008] U.S. Patent No. 11,511,100 discloses a single universal sterilization cap device having features that allow it to interface with either male or female threaded connectors. Figures 1 and 2 correspond to the corresponding figures of U.S. Patent No. 11,511,100. Figure 7 10 , but with different reference numerals and lead lines. In FIGS. 1 and 2 , cap 10 includes a housing 12 comprising an inner sidewall 14 and an axial wall 16 defining a first cavity 18, and an open bottom 20 extending into first cavity 18. Extending from wall 16 is a protrusion 22 (which may be substantially cylindrical and coaxial with inner sidewall 14), the protrusion having an inner surface 24 defining a second cavity 26 and a tapered outer surface 28 defining an outer portion of first cavity 18. Protrusion 22 includes internal threads 30 on its inner surface 24 for engaging a female Luer connector, and outer surface 28 is tapered and sized and adapted to engage a male Luer connector with a press-fit connection sufficient to interlock with a mating feature of the male needleless connector. Protrusion 22 is illustrated as including two prongs 32 separated by a cutout or gap 34 and extending substantially proximally from distal wall 16.

[0009] 2 , in one or more embodiments, an absorbent material 36 is disposed within the chamber defined by the first and second cavities 18 and 26 . The absorbent material is radially compressed by the internal threads 30 on the inner surface 24 of the protrusion 22 to retain the absorbent material 36 within the first and second cavities 18 and 26 . As shown in FIG2 , in one or more embodiments, the absorbent material 36 includes an inner cylindrical material 38 and an outer cylindrical material 40 . The inner cylindrical material 38 is disposed within the second cavity 26 , while the outer cylindrical material 40 is disposed within the first cavity 18 . The outer cylindrical material 40 is a ring having an orifice having a diameter substantially equal to the outer diameter of the protrusion 22 , such that the outer cylindrical material 40 is disposed only within the first cavity 18 , contacting the inner sidewall 14 of the housing 12 and the outer surface 28 of the protrusion 22 . When disposed within the first or second cavity 18 , the absorbent material 36 , the inner cylindrical material 38 , and the outer cylindrical material 40 abut the axial end wall 16 . Summary of the Invention

[0010] Embodiments of the present disclosure relate to a universal cap for connecting to and sterilizing a medical connector, including a male connector and a female connector. The universal cap embodiments disclosed herein facilitate easier alignment and engagement of the cap with a threaded male or female Luer medical connector and enhance connector sterilization. A split collar protrusion projects axially from a closed end wall of the cap toward an open bottom and includes at least one pair of opposed parallel, fan-shaped collet fingers / forks terminating at the protrusion ends. Some cap embodiments have more than two collet fingers / forks. The interior walls of each collet finger / fork of the split collar protrusion respectively define a split flange cantilever. Each split flange has a flange root coupled to its corresponding interior wall from which an axial contact surface projects, the axial contact surface terminating at the flange end. In general, the respective flange ends of the split flange are in a radially inwardly opposed orientation relative to the axial centerline of the split collar protrusion and are generally oriented axially along the protrusion inner wall between the closed end wall and the protrusion end. Although two collet fingers / forks 61 are shown in the embodiment of this cap 50, other embodiments incorporate more than two collet fingers / forks. The inner and outer walls of each collet finger / fork define a split internal thread and an external thread, respectively, which are sized to mate with the corresponding female and male threads of the Luer connector. An absorbent material is oriented between the split flange and the bottom of the cap. In some embodiments, the absorbent material is injected with an antimicrobial agent. When the cap is attached to the Luer connector, compression of the absorbent material biases the split flange toward the cap end wall and deflects the ends of the collet fingers / forks radially inward toward the axial centerline of the cap, making it easier for the cap to align and engage with the corresponding connector and enhancing connector disinfection. The exemplary caps disclosed herein provide a mechanical barrier for medical connectors and retain antimicrobial agents for sterilization. The caps disclosed herein allow medical practitioners to streamline the sterilization process by simplifying the cap / connector engagement while sterilizing the connector.

[0011] One aspect of the present disclosure relates to a cap for coupling to a male or female Luer medical connector. The cap includes a housing having an axial centerline. The cap defines a first cavity formed within the housing top wall and circumscribing housing sidewalls. The cavity is in communication with the open bottom of the housing. A split collar protrusion is oriented within the first cavity, coupled to the top wall, circumscribing the axial centerline and protruding toward the open bottom. The protrusion has a plurality of opposed, parallel, fan-shaped collet prongs, also known as collet fingers. Each corresponding collet finger / fork has a distal protrusion tip and a protrusion outer wall surface, the protrusion outer wall surface defining an outer wall split thread, the outer wall split thread being sized and adapted to mate with a corresponding collar thread of a male Luer connector. Each corresponding collet finger / fork also has an inner wall surface defining an inner wall split thread, the inner wall split thread being sized and adapted to mate with a corresponding thread of a female Luer connector. The corresponding inner wall split threads and the corresponding outer wall split threads begin at the distal protrusion tip and terminate near the top wall. The corresponding inner surfaces of the collet fork define a second cavity sized and adapted to receive a male or female Luer connector. A split flange is coupled to the inner wall surface of each corresponding collet fork between the inner split threads and the top wall via a flange root. Each separate, corresponding split flange has a cantilevered distal axial contact surface that is generally oriented radially inward relative to the axial centerline of the housing and terminates at a flange tip radially opposite the other flange tip. An absorbent material is interposed within the second cavity between the corresponding split flange and the open bottom of the housing. The absorbent material compresses during advancement of the male or female Luer connector within the second cavity, biasing the split flange toward the top wall of the housing. The now biased split flange deflects the protrusion tip of its corresponding collet fork inward toward the axial centerline of the housing.

[0012] This Summary is provided to introduce some concepts in a simplified form that are further described below in the Detailed Description. Additional features and advantages of the disclosure are set forth in the following description and the appended claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0014] FIG. 1 is an isometric view of an embodiment of a universal cap for coupling to either a male or female Luer connector, corresponding to FIG. Figure 7 ;

[0015] FIG2 is an axial cross-sectional view of the universal cap of FIG1 , which corresponds to FIG10 of U.S. Patent No. 11,511,100;

[0016] Figure 3 is an exploded isometric view of one embodiment of a universal cap of the present disclosure for coupling to either a male or female luer connector;

[0017] Figure 4 yes Figure 3 An axial cross-sectional view of a universal cap;

[0018] Figure 5 yes Figure 3 A bottom plan view of a universal cap;

[0019] Figure 6 The diagram corresponds to Figure 4 The compressive force F applied to the universal cap of the present disclosure C The resulting torque T F and the radially inward deflection D of the cap protrusion P Schematic force application diagram;

[0020] Figure 7 is an axial cross-sectional view of the universal cap of the present disclosure engaged with a male luer connector; and

[0021] Figure 8 is an axial cross-sectional view of the universal cap of the present disclosure engaging a female Luer connector.

[0022] To facilitate understanding, identical reference numerals have been used, where possible, to designate identical elements that are common to the figures.The figures are not drawn to scale. DETAILED DESCRIPTION

[0023] Embodiments of the present disclosure relate to a universal cap for connecting to and sterilizing a medical connector, the medical connector comprising a male connector and a female connector. In some embodiments, the male connector and the female connector are a threaded male Luer connector and a female Luer connector. The universal cap embodiments disclosed herein facilitate easier alignment and engagement of the cap with a threaded male or female Luer medical connector and enhance connector sterilization. A split collar protrusion protrudes axially from the closed end wall of the cap toward the open bottom and comprises at least one pair of opposed parallel, fan-shaped, collet fingers / forks that terminate at the protrusion ends. The inner walls of each collet finger define a split flange cantilever, respectively. The inner and outer walls of each collet finger define a split thread, each of which is sized to mate with a corresponding corresponding thread of the Luer connector. An absorbent material is oriented between the split flange and the bottom of the cap. In some embodiments, the absorbent material is injected with an antimicrobial agent. When the cap is attached to the Luer connector, compression of the absorbent material biases the split flange toward the cap end wall and deflects the collet fingers / forks radially inward toward the cap's axial centerline, making it easier to align and engage the cap with the connector and enhancing connector disinfection. The exemplary caps disclosed herein provide a mechanical barrier for medical connectors and retain antimicrobial agents for disinfection. The caps disclosed herein allow medical practitioners to streamline the sterilization process by simplifying the cap / connector engagement while the connector is being sterilized.

[0024] In this disclosure, where generally applicable, the convention is generally followed where the distal end of a device is the end closest to the patient, and the proximal end of the device is the end away from the patient and closest to the clinician or other medical practitioner. Thus, with respect to the universal cap disclosed herein, the open end of the cap that connects to a male or female Luer connector is referred to as its distal end, and the closed end of the cap is referred to as its proximal end. As used herein, the use of "a," "an," and "the" includes both the singular and the plural.

[0025] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or IV line.

[0026] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method of attaching syringes, catheters, hub needles, IV tubing, etc. to each other. A Luer connector consists of male and female interlocking tubes that are slightly tapered so that they can be better held together even with just a simple press / twist fit. The Luer connector may optionally include an additional threaded outer rim to make it more secure. The male end of the Luer connector is generally associated with a flush syringe and can interlock and connect to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a molded center passageway for fluid communication from the chamber of the barrel of the syringe to the hub of the VAD. The Luer connector also has a distal end channel and a proximal end channel, the distal end channel releasably attaching the Luer connector to the hub of the VAD and the proximal end channel releasably attaching the Luer connector to the barrel of the syringe.

[0027] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "lock," "end," "hub," "thread," "sponge," "fork," "protrusion," "wall," "top," "side," "bottom," etc. are used throughout the specification to facilitate understanding, they are not intended to limit any components that may be used in combination or alone to implement various aspects of the embodiments of the present disclosure.

[0028] As used herein, the term "medical device" refers to a common medical device having a threaded or interlocking connection with a corresponding mating component. By way of example and not limitation, a syringe may have a male threaded connection that releasably interlocks with a secondary medical device such as a male Luer connector for a catheter, IV tubing, and the like. The threaded connection may include a lumen defining a fluid path surrounded by a protruding wall having a threaded mechanism for attachment to the secondary medical device.

[0029] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "thread," "taper," "tongue," "bevel," "wall," "top," "side," "bottom," and other terms are used throughout this specification to facilitate understanding, they are not intended to limit any components that may be used in combination or alone to implement various aspects of the embodiments of the present disclosure.

[0030] The matters illustrated in this specification are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and configurations have been omitted for clarity and brevity.

[0031] Exemplary embodiments of the present disclosure provide a cap that can reduce by approximately half the number of device types and logistics currently required for connecting, capping, and / or sterilizing male and female threaded fluid luer connectors in a hospital setting by including a single cap or device feature that allows it to be used with both male and female needleless connectors.

[0032] According to another exemplary embodiment of the present disclosure, the female thread is sized and has a thread pattern to engage with a standard ISO 594-2 type male fitting and / or male thread, and the standard ISO 594-2 type male fitting and / or male thread is sized and has a thread pattern to engage with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a Q-style fitting.

[0033] In one or more embodiments, the female needleless connector can be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from the group consisting of a Q-Syte connector, Max Plus, Max Plus Clear, Max Zero, Ultra Site, Caresite, In Vision-Plus, Safeline, One Link, V-Link, Clear Link, Neutra Clear, Clave, Micro Clave, MicroClave Clear, Neutron, Nano Clave, Kendall, Nexus, In Vision, Vadsite, Bionector, and the like.

[0034] In one or more embodiments, the male connector may be an intravenous tubing tip, a stopcock, or a male lock luer.

[0035] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description, and the present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0036] The matters illustrated in this specification are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications may be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and configurations have been omitted for clarity and brevity.

[0037] refer to Figures 3 to 5, a first aspect of the present disclosure relates to a cap 50 having a housing 52 having a housing sidewall 54 and a closed top or end wall 56 on the proximal end of the housing. The distal or bottom end of the housing 52 defines an open bottom 58. A split collar protrusion 60 projects axially from the closed top wall 56. As shown, the split collar protrusion includes a pair of opposed parallel, scalloped collet fingers 61 (also referred to herein as collet forks), each collet finger having a distal, axially oriented protrusion tip 62, a protrusion outer wall 64, and split outer wall threads 66, the split outer wall threads 66 being sized to mate with corresponding collar threads of a male Luer connector. The split outer wall threads 66 begin at the protrusion tip 62 and terminate near the top wall 56.

[0038] Each collet finger / fork 61 defines a protrusion interior wall 68 and a cantilevered split flange 70. Each split flange 70 has a flange root 71 coupled to its corresponding protrusion interior wall 68, from which a distal axial contact surface 72 projects, terminating in a flange tip 73. Generally speaking, the respective flange tips 73 of the split flanges 70 are oriented radially inwardly relative to the axial centerline of the split collar protrusion 60 and are generally radially oriented along the protrusion interior wall intermediate the closed top wall 60 and the protrusion tips 62. While two collet fingers / forks 61 are shown in the embodiment of the cap 50, other embodiments include more than two collet fingers.

[0039] Generally speaking, the collet fingers / forks 61 define a circular plan view about an axial centerline, as shown. Figure 5 6, and a generally cylindrical protrusion outer wall 64 having radially outward-facing, male Luer-engageable, split external threads 66. The inner wall 68 of each of the collet fingers 61 defines radially inward-facing, female Luer-engageable, split internal threads 74 that begin at the protrusion tip 62 and terminate near the top wall 56 before the split flange 70. Overall, the protrusion inner wall 68 defines a cylindrical inner second cavity 76 and an annular outer first cavity 78. In other embodiments, the cap has a protrusion that includes any number of collet fingers / prongs that are identical and / or different (in any dimensional characteristic, such as length, width, thickness, or shape), so long as the protrusion is configured to engage a female connector with its internal split threads on its inner surface and a male connector with its external split threads on its outer surface.

[0040] A cylindrical absorbent material 80 having a proximal axial surface 82 is inserted into the interior second cavity 76 and retained by radial compression and frictional engagement with the split threads 74 that are engageable with the female Luer. The absorbent material 80 abuts the axial contact surface 72 of each of the split flanges 70. In one or more embodiments, the absorbent material 80 is a nonwoven material, foam, or sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, the absorbent material 80 is in the form of a foam plug. In yet another exemplary embodiment, one or more disinfecting components (such as, the absorbent material 80) are in the form of an IPA-soaked sponge and / or sponge.

[0041] Cap 50 can disinfect the Luer connector by integrating a disinfectant or antimicrobial agent into the absorbent material 80. In some embodiments, the disinfectant or antimicrobial agent is directly contained within the inner cylindrical cavity 76 and / or the outer annular cavity 78. In other embodiments, the disinfectant or antimicrobial agent is absorbed into the sponge or foam material comprising the absorbent material 80. Cap 50 is compatible with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent comprises alcohol or a variant of chlorohexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, chloride), octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine acetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0042] When connected to a female or male Luer connector, the compression of the absorbent material 80 toward the closed end wall 56 of the housing 52 allows the connector to contact a disinfectant or antimicrobial agent to sterilize the connector. Thus, the compression of the absorbent material 80 when the cap 50 is coupled to the Luer connector sterilizes the connector.

[0043] refer to Figures 6 to 8 The cap 50 embodiment enhances alignment, threaded engagement, and sterilization of the male or female Luer connector 90 , 110 when they are coupled together and compress the absorbent material (eg, sponge) 80 . Figure 6 Schematically illustrates the insertion force F of the split collar protrusion 60 in the axial direction when the cap 50 is attached to a male or female Luer connector. C When the sponge 80 is compressed, the insertion force F C against the respective distal axial contact surfaces 72 of the opposed split flange 70, thereby applying a moment T about the flange root 71. F The applied torque T F The flange 70 and its flange end 73 are biased and deflected in the radially outward direction as shown by the moment arrow. Under the reaction, the collet finger / fork 61 is deflected as shown by the deflection arrow D P The depicted radially inward deflection causes the collet fingers to be in a relaxed state and without applying the insertion force F. C Their respective distal tips 62 are radially closer to the axial centerline of the cap 50 than when the distal tips 62 are radially closer to the axial centerline of the cap 50. Figure 7 and Figure 8 The example of Luer connector engagement shown in FIG. 5 shows the collet fingers / forks 61 deflecting D in the cap 50 embodiment. P Advantages.

[0044] exist Figure 7 , cap 50 is applied to an exemplary threaded male Luer IV connector 90. IV connector 90 incorporates a male Luer tip 92 having a proximal male end 94 having a curved rollover edge 96 that blends into the Luer's tapered circumferential exterior surface 97 and lumen 98. A collar 99 of IV connector 90 defines a collar interior surface 100 having male Luer threads 102 and terminates in a collar proximal edge 104. During attachment of cap 50 to IV connector 90, the proximal male end 94 of the connector comes into contact with the distal axial surface 82 of the disinfectant sponge 80 before contact is made between the distal end 62 of the cap and the collar proximal edge 104 of the connector. This, in turn, reduces the axial insertion force F CA load is applied to the sponge 80, thereby compressing the sponge. The compressed sponge transfers the axial load to the cantilevered split flange 70, causing the distal tips 62 of the collet fingers / forks 61 and their outer wall threads 66 to deflect radially inward toward the axial centerline of the cap 50. Due to the compression of the sponge 80, the distal tips 62 of the collet fingers / forks 61 and their outer wall threads 66 flex inward, providing radial engagement clearance between themselves and the corresponding interior surfaces 100 and the proximal edge 104 of the collar 99 prior to contact engagement of the cap outer wall threads 66 and the IV connector male Luer threads 102. The deflection of the collet fingers 61 improves engagement tolerances and / or reduces the interference fit between the now engageable outer wall split threads 66 of the cap 50 and the male Luer threads 102 of the IV connector 90.

[0045] In addition to improving the engagement tolerances and / or reducing the interference fit of the cap 50 and the male IV connector 90 for enhanced component mating, the cap embodiments disclosed herein also enhance sterilization of the tapered male luer portion 92 during cap engagement. C When the split flange 70 is deflected, the distal axial surface 82 of the compressed sponge 80 is biased against the proximal end 94, the turned edge 96 and the upper adjoining circumferential outer surface 97 of the tapered male luer portion 92, thereby scrubbing them with the disinfectant retained within the sponge. When the cap 50 and the male IV connector 90 are threaded together, the additional circular scrubbing action further disinfects the tapered male luer portion 92.

[0046] exist Figure 8 In FIG. 5 , cap 50 is applied to an exemplary threaded female Luer IV connector 110. Female IV connector 110 has a tapered female portion, a sidewall 114, and a proximal end 116 for complementary engagement with a corresponding male Luer connector. An exterior surface 118 of sidewall 114 defines female Luer threads 120. When cap 50 is applied to female IV connector 110, the corresponding mating interior wall split threads 74 of the cap and the threads 120 of the female IV connector contact and engage with each other before the proximal end 116 of the female IV connector contacts the distal axial surface 82 of the disinfectant sponge. Thus, the opposing split flange 70 and collet fingers 61 are in a relaxed state, allowing the cap 50 split threads 74 and the female IV connector threads 120 to mate with each other without significant friction or radial engagement interference. As the cap 50 is tightened, compressing the sponge 80, the distal tips 62 of the collet fingers / forks 61 deflect inwardly toward the axial centerline of the cap, thereby radially compressing the mating split threads 74 and female IV connector threads 120 relative to each other; this tightens the cap and female IV connector grip.

[0047] Thus, the same universal cap 50 of the present disclosure with its split collar protrusion 60 facilitates easier cap alignment, connection with a male Luer connector such as Figure 7 The male IV connector 90) is connected and enhanced disinfection, while also enhancing the female Luer connector (such as Figure 8 The self-aligning cap 50 is a versatile cap that allows for the sterilization and engagement of female IV connectors (e.g., male and female Luer connectors) with a single sterilization and sealing solution for both male and female Luer fittings. This reduces inventory costs and requires clinicians to be familiar with only one type of cap to meet all sealing and Luer fitting sterilization needs.

[0048] In various embodiments, the cap 50 of the present disclosure is made of any of various types of plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate (glycol-modified polyethylene terephthalate), acrylonitrile-butadiene-styrene or any other injection moldable medical grade plastic material used in medical devices. In one or more embodiments, the cap 50 comprises polypropylene or polyethylene material. In certain embodiments, the cap 50 is a single-piece structure. In certain embodiments, the cap 50 is a single-piece structure made of medical grade plastic. In certain embodiments, the cap 50 is formed by an injection molding process. In certain embodiments, the closed top wall or end wall 56 of the housing sidewall 54 and the housing 52 is an integral structure, and the split collar protrusion 60 comprising the clamp finger / fork 61 is separate, an integral structure, and the two integral parts are attached to each other by heat or friction welding, adhesive or mechanical rivet / fastening.

[0049] Example

[0050] Embodiment (a): A cap for connecting to a male or female Luer medical connector, comprising: a shell having an axial centerline and an open bottom of the shell, the axial centerline defining a first cavity, the first cavity being formed within a top wall of the shell and surrounding side walls of the shell; a split collar protrusion within the first cavity, the split collar protrusion being connected to the top wall, surrounding the axial centerline and protruding toward the open bottom, the protrusion having a plurality of opposed, parallel, fan-shaped collet forks, each fork having a distal protrusion end, a protrusion outer wall surface and an inner wall surface, the protrusion outer wall surface defining an outer wall split thread, the outer wall split thread being sized and adapted to mate with a corresponding collar thread of a male Luer connector, the inner wall surface defining an inner wall split thread , the interior wall split threads being sized and adapted to mate with corresponding threads of a female Luer connector, the respective interior wall split threads and the respective exterior wall split threads commencing at the distal protrusion tip and terminating proximate the top wall, the respective interior surfaces of the collet tines defining a second cavity sized and adapted to receive a male or female Luer connector: a split flange coupled to the interior wall surface of each respective collet tines via a flange root intermediate the interior wall split threads and the top wall, each separate, respective split flange having a cantilevered distal axial contact surface oriented generally radially inwardly relative to an axial centerline of the housing and terminating in a flange end radially opposite the other flange end; and

[0051] an absorbent material interposed between the corresponding split flange and the open bottom of the housing within the second lumen, the absorbent material compressing during advancement of the male or female Luer connector within the second lumen and biasing the split flange toward the top wall of the housing, the now biased split flange causing the protruding tip of its corresponding collet tines to deflect inwardly toward the axial centerline.

[0052] Embodiment (b): According to the cap of embodiment (a), when the tapered male end of the threaded male Luer connector is inserted and advanced into the second cavity and compresses the absorbent material, the protruding end of each fork is deflected radially inwardly away from the proximal edge of the collar of the male Luer connector and the inner collar surface, thereby avoiding interference contact between the fork end and the collar.

[0053] Embodiment (c): The cap according to embodiment (b), wherein the adjacent proximal end, turned edge and circumferential outer surface of the tapered male end of the threaded male luer connector compress the absorbent material when it is inserted and threadedly advanced into the second cavity, and the absorbent material scrubs the proximal end, turned edge and circumferential outer surface during tightening of the corresponding threads of the cap and the male luer connector.

[0054] Embodiment (d): According to the cap described in embodiment (a), when the threaded female Luer connector is inserted and threadedly moved forward into the second cavity and the absorbent material is compressed, the protruding end of each fork-shaped member deflects radially inward and biases its inner wall split thread so that it contacts the corresponding thread formed on the side wall of the outer surface of the female Luer connector.

[0055] Embodiment (e): The cap of embodiment (d), wherein the absorbent material scrubs the surface of the tapered female portion of the female Luer connector during tightening of the cap and corresponding threads of the female Luer connector.

[0056] Embodiment (f): The cap of embodiment (a), further comprising a disinfectant or antimicrobial agent retained within the absorbent material.

[0057] Embodiment (g) The cap of embodiment (f), wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0058] Embodiment (h): The cap of embodiment (g), wherein the disinfectant or antimicrobial agent is a fluid or a gel.

[0059] Embodiment (i): The cap of embodiment (f), wherein the disinfectant or antimicrobial agent is a fluid or a gel.

[0060] Embodiment (j): The cap of embodiment (a), wherein the absorbent material is foam or polyurethane foam or sponge.

[0061] Embodiment (k): The cap of embodiment (a), wherein the split collar protrusion comprises a pair of collet tines and a corresponding split flange.

[0062] Embodiment (1): The cap according to embodiment (k), wherein the cap comprises a monolithic structure.

[0063] Embodiment (m): The cap according to embodiment (l), wherein the single-piece structure of the cap is formed by injection molding the cap.

[0064] References throughout this specification to "one embodiment," "certain embodiments," "various embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "in certain embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0065] Although the disclosure herein provides a description with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, the present disclosure is intended to include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A cap for coupling to a male or female Luer medical connector, comprising: a housing having an axial centerline defining a first cavity formed within a housing top wall and surrounding housing side walls; and an open bottom portion of the housing; a split collar protrusion within the first lumen, the split collar protrusion coupled to the top wall, surrounding the axial centerline and projecting toward the open bottom, the protrusion having a plurality of opposed, parallel, scalloped collet tines, each tines having: a distal protrusion tip, a protrusion outer wall surface defining split outer wall threads sized and adapted for mating engagement with corresponding collar threads of a male luer connector, and an inner wall surface defining split inner wall threads sized and adapted for mating engagement with corresponding threads of a female luer connector, the respective split inner wall threads and respective split outer wall threads commencing at the distal protrusion tip and terminating proximate the top wall, the respective inner surfaces of the collet tines defining a second lumen sized and adapted to receive a male or female luer connector; a split flange coupled to the interior wall surface of each respective collet tines via a flange root intermediate the interior wall split threads and the top wall, each separate, respective split flange having a cantilevered distal axial contact surface oriented generally radially inwardly relative to an axial centerline of the housing and terminating in a flange end radially opposite the other flange end; as well as an absorbent material interposed between the corresponding split flange and the open bottom of the housing within the second lumen, the absorbent material compressing during advancement of the male or female Luer connector within the second lumen and biasing the split flange toward the top wall of the housing, the now biased split flange deflecting the protruding tip of its corresponding collet fork inwardly toward the axial centerline.

2. The cap of claim 1 , wherein when the tapered male end of the threaded male luer connector is inserted and advanced into the second cavity and compresses the absorbent material, the protruding end of each prong deflects radially inwardly, away from the proximal edge of the collar of the male luer connector and the inner collar surface, thereby avoiding interference contact between the prong end and the collar.

3. The cap of claim 2 , wherein the adjoining proximal tip, turned edge, and circumferential exterior surface of the tapered male end of the threaded male luer connector compresses the absorbent material as it is inserted and threadedly advanced into the second cavity, and the absorbent material scrubs the proximal tip, turned edge, and circumferential exterior surface during tightening of the respective threads of the cap and the male luer connector.

4. The cap according to claim 1, wherein when the threaded female Luer connector is inserted and threadedly advanced into the second cavity and the absorbent material is compressed, the protruding end of each fork-shaped member deflects radially inward and biases its inner wall split thread to contact the corresponding thread formed on the outer surface side wall of the female Luer connector.

5. The cap of claim 4, wherein the absorbent material scrubs the surface of the tapered female portion of the female Luer connector during tightening of the cap and corresponding threads of the female Luer connector.

6. The cap of claim 1 further comprising a disinfectant or antimicrobial agent retained within the absorbent material.

7. The cap of claim 6, wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

8. The cap of claim 7, wherein the disinfectant or antimicrobial agent is a fluid or a gel.

9. The cap of claim 6, wherein the disinfectant or antimicrobial agent is a fluid or a gel.

10. The cap of claim 1, wherein the absorbent material is foam or polyurethane foam or sponge.

11. The cap of claim 1 , said split collar protrusion comprising a pair of collet prongs and a corresponding split flange.

12. The cap of claim 11, comprising a monolithic structure.

13. The cap of claim 12, the single-piece structure of the cap being formed by injection molding the cap.

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