Automatic alignment universal cap for male and female lure connectors

Abstract

A universal cap for connecting to medical connectors facilitates cap alignment and engagement with threaded male or female Luer medical connectors and enhances connector disinfection. The split collar projection protrudes axially from the closed end wall of the cap toward the open bottom and features at least two opposing parallel sector-shaped collet fingers / prongs terminating at the tip of the projection. The inner wall of each collet finger defines a split flange cantilever. The inner and outer walls of each collet finger define split threads sized to mate and engage with the corresponding threads of the Luer connector. An antimicrobially injected absorbent material is oriented between the split flange and the bottom of the cap. When the cap is attached to the Luer connector, the compression of the absorbent material biases the split flange and deflects the collet fingers / prongs, facilitating cap alignment and engagement with the Luer medical connector and enhancing connector disinfection.

Description

[Technical Field]

[0001] This disclosure generally relates to devices for disinfecting and sterilizing access ports, for example, those having male and / or female Luer connectors, and more particularly to disinfection and sterilization devices that can accommodate multiple types of connectors. Generally, exemplary embodiments of this disclosure relate to the field of threaded fittings, including medical caps and medical disinfection caps, and more particularly to medical caps and / or disinfection caps for universal use in either or both male and female fluid Luer connectors. [Background technology]

[0002] Vascular access devices (VADs) are common therapeutic devices, including intravenous (IV) catheters. VADs are broadly classified into two types: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter the patient's vascular system through access hubs or ports / valves when connecting to VADs for the delivery of fluids or medications. Each access hub (or access port / valve or connection) carries the risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be highly fatal.

[0003] To reduce CRBSI cases and ensure that VADs are used and maintained correctly, implementation standards, including disinfection and cleaning procedures, have been developed.

[0004] The American Society for Healthcare Epidemiology (SHEA) guidelines have included disinfectant caps, and it was also pointed out early on that caps would be incorporated into the 2016 Infusion Nursing Standards (INS) guidelines.

[0005] In advanced markets, when using IV catheters, a needleless connector is typically used to close the system, and then access is made to administer medications and other necessary fluids to the patient via the catheter. INS (Intravenous Nursing Standards) guidelines recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected before each access with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination." Disinfection of needleless connectors ultimately aims to help reduce bacteria that inhabit the surface and can cause various catheter-related complications, including CRBSI (Chronic Biological Respiratory Syndrome). Nurses can typically complete the disinfection process by using a 70% isopropyl alcohol (IPA) pad and performing a procedure called "hub scrubbing." However, adherence to this practice is generally very low. In addition to the lack of adherence to "hub scrubbing," interviews with clinicians have also noted frequent variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0006] There are numerous risks of contact or contamination throughout the series of procedures involved in the transmission of microorganisms that can cause CRBSI. Contamination can occur during drug mixing, cannula attachment, and insertion into the access hub. Because the procedure for connecting to a VAD is extremely common and simple, the risks associated with invasion into the patient's vascular system are often overlooked. Currently, the risks to hospitals and patients are largely a result of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.

[0007] Currently, male needleless connectors, female needleless connectors, and caps for intravenous (IV) and hemodialysis lines use different designs, and therefore, caps are limited to the type of connector they can be attached to. Currently, there are male disinfection cap devices for disinfecting female screw-type fluid luer connectors of ISO 594-2 type, and also female disinfection cap devices for disinfecting male screw-type fluid luer connectors of ISO 594-2 type. Therefore, conventional disinfection caps are designed to fit only one type of connector and are specific to a particular size and / or connector shape.

[0008] Patent Document 1 discloses a single universal disinfection cap device having the feature of being able to interface with either a male or female threaded connector. Figures 1 and 2 are structural diagrams corresponding to Figures 7 and 10 of Patent Document 1, but have different reference numbers and lead lines. In Figures 1 and 2, the cap 10 includes a housing 12, the housing 12 includes an inner side wall 14, an axial wall 16 defining a first cavity 18, and an open bottom 20 into the first cavity 18. Extending from the wall 16 is a projection 22 (essentially cylindrical and possibly coaxial with the inner side wall 14) having an inner surface 24 defining a second cavity 26 and a tapered outer surface 28 defining the outer portion of the first cavity 18. The projection 22 includes internal threads 30 on its inner surface 24 for engaging with a female luer connector, and its outer surface 28 is tapered, dimensional, and fitted to engage with the male luer connector in a press-fit connection sufficient to interlock with the mating feature of the male needleless connector. The projection 22 is shown to include two prongs 32 that are spaced apart by a notch or gap 34 and extend essentially from the distal wall 16 in the proximal direction.

[0009] Referring to Figure 2, in one or more embodiments, the absorbent material 36 is placed in a chamber defined by a first cavity 18 and a second cavity 26, and the absorbent material is radially compressed by an internal screw 30 on the inner surface 24 of the projection 22 to hold the absorbent material 36 in the first cavity 18 and the second cavity 26. As shown in Figure 2, 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 placed in the second cavity 26, and the outer cylindrical material 40 is placed in the first cavity 18, and the outer cylindrical material 40 is a ring with an opening and opening diameter essentially equal to the outer diameter of the projection 22, in contact with the inner side wall 14 of the housing 12 and the outer surface 28 of the projection 22, such that the outer cylindrical material 40 is placed only in the first cavity 18. The absorbent material 36, the inner cylindrical material 38, and the outer cylindrical material 40 abut against the axial end wall 16 when placed within the first cavity 18 or the second cavity 24. [Prior art documents] [Patent Documents]

[0010] [Patent Document 1] U.S. Patent No. 11,511,100 [Overview of the project]

[0011] Embodiments of this disclosure relate to a universal cap for connection to and disinfection of medical connectors, including male and female connectors. Embodiments of the universal cap disclosed herein facilitate cap alignment and engagement with threaded male or female Luer medical connectors and enhance connector disinfection. The split collar projection comprises at least two opposing parallel sector-shaped collet fingers / prongs projecting axially from the closed end wall of the cap toward the open bottom and terminating at the tip of the projection. Some cap embodiments have two or more collet fingers / prongs. The inner wall of each collet finger / prong of the split collar projection each defines a split flange cantilever. Each split flange has a flange root coupled to a corresponding inner wall, from which an axial contact surface projecting terminates at the flange tip. In summary, the flange tip of each split flange is radially inwardly opposed to the axial centerline of the split collar projection, and is generally axially oriented along the inner wall of the projection, between the closed end wall and the projection tip. Two collet finger / prongs 61 are shown in this embodiment of the cap 50, but other embodiments incorporate two or more of them. The inner and outer walls of each collet finger / prong define split internal and external threads, respectively, sized to mate and engage 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 impregnated with an antimicrobial agent. When the cap is attached to the Luer connector, the compression of the absorbent material biases the split flange toward the cap end wall, deflecting the tips of the collet finger / prongs radially inward toward the axial centerline of the cap, facilitating cap alignment and engagement with the corresponding connector and enhancing the disinfection of the connector. The exemplary caps disclosed herein provide a mechanical barrier for medical connectors and retain antimicrobial agents for disinfection.The cap of this disclosure enables physicians to streamline the disinfection process by simplifying cap / connector engagement while simultaneously disinfecting the connector.

[0012] One aspect of the present disclosure relates to a cap for coupling to a male or female Luer medical connector. The cap comprises a housing having an axial centerline. The cap defines a first cavity formed in the upper wall and the outer side wall of the housing. The cavity communicates with the open bottom of the housing. A split collar projection is oriented within the first cavity, coupled to the upper wall, encircling the axial centerline, and projecting toward the open bottom. This projection has a plurality of opposing parallel sector-shaped collet prongs, also called collet fingers. Each collet finger / prong has a distal projection tip and a projection outer wall surface, which defines an outer wall split thread sized and adapted for mating engagement with the corresponding collar thread of a male Luer connector. Each collet finger / prong also has an inner wall surface that defines an inner wall split thread sized and adapted for mating engagement with the corresponding thread of a female Luer connector. Each inner wall split thread and each outer wall split thread begin at the distal projection tip and terminate close to the upper wall. The inner surface of each collet prong defines a second cavity sized and adapted to receive a male or female Luer connector. The split flanges are coupled to the inner wall surfaces of each collet prong by flange roots and are located between the inner split threads and the upper wall. Each separate split flange has a cantilevered distal axial contact surface, which is generally oriented radially inward with respect to the axial centerline of the housing and terminates at a flange tip radially opposite to the other flange tip. Absorbent material is placed in the second cavity between each split flange and the open bottom of the housing, and the absorbent material is compressed as the male or female Luer connector advances within the second cavity, biasing the split flange toward the upper wall of the housing. The currently biased split flange deflects the protruding tips of each collet prong inward toward the axial centerline of the housing.

[0013] This summary is provided to introduce a selection of concepts that will be further explained in the detailed description below. Additional features and benefits of this disclosure are described below and in the attached claims. [Brief explanation of the drawing]

[0014] Exemplary embodiments of this disclosure are further described in the following detailed description in conjunction with the accompanying drawings. [Figure 1] Figure 1 is an isometric view of an embodiment of a universal cap for coupling to either a male or female Luer connector, corresponding to Figure 7 in Patent Document 1. [Figure 2] Figure 2 is an axial cross-sectional view of the universal cap shown in Figure 1, corresponding to Figure 10 in Patent Document 1. [Figure 3] Figure 3 is an exploded isometric view of one embodiment of the universal cap of the present disclosure for coupling to either a male or female Luer connector. [Figure 4] Figure 4 is an axial cross-sectional view of the universal cap shown in Figure 3. [Figure 5] Figure 5 is a bottom view of the universal cap shown in Figure 3. [Figure 6] Figure 6 is a schematic force application diagram showing the compressive force FC, the resulting torque moment TF, and the radially inward deflection DP of the cap projection applied to the universal cap of this disclosure, corresponding to Figure 4. [Figure 7] Figure 7 is an axial cross-sectional view of the universal cap of this disclosure engaging with a male luer connector. [Figure 8] Figure 8 is an axial cross-sectional view of the universal cap of this disclosure engaging with a female Luer connector.

[0015] For ease of understanding, the same reference number is used to indicate identical elements common to the drawings, where possible. The drawings are not drawn to scale. [Modes for carrying out the invention]

[0016] Embodiments of the present disclosure relate to a universal cap for connection and disinfection of medical connectors including male and female connectors. In some embodiments, the male and female connectors are threaded male and female luer connectors. Embodiments of the universal cap disclosed herein facilitate cap alignment and engagement with threaded male or female luer medical connectors and enhance connector disinfection. Split-color protrusions project axially from the closed end wall of the cap towards the open bottom and include at least opposing parallel sector-shaped collet fingers / prongs terminating at the tip of the protrusion. The inner wall of each collet finger defines a split flange cantilever respectively. The inner and outer walls of each collet finger define split threads sized to matingly engage corresponding threads of the luer connector respectively. Absorbent material is oriented between the split flange and the cap bottom. In some embodiments, the absorbent material is infused with an antibacterial agent. When the cap is attached to the luer connector, compression of the absorbent material biases the split flange towards the cap end wall, deflecting the collet fingers / prongs radially inward towards the axial centerline of the cap, facilitating cap alignment and engagement with the connector, and enhancing connector disinfection. The exemplary cap disclosed herein provides a mechanical barrier for medical connectors and holds an antibacterial agent for disinfection. The cap of the present disclosure enables a physician to streamline the disinfection process by simplifying cap / connector engagement while simultaneously disinfecting the connector.

[0017] In the present disclosure, where generally applicable, the convention is generally followed that the distal end of a device is the end closest to the patient, the proximal end of the device is the end farthest from the patient, and the end closest to the clinician or other physician. 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 singular and plural forms.

[0018] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" means any infectious disease caused by the presence of a catheter or IV line.

[0019] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way to attach syringes, catheters, needle with hubs, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes and is slightly tapered so that it can be firmly coupled with just a simple press / twist fit. The Luer connector can optionally add a peripheral edge outside the thread to enhance safety more. The male end of the Luer connector is generally associated with a flush syringe and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an outer wall of irregular shape, and a shaped central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Also, the Luer connector has a distal end channel removably attached to the hub of the VAD and a proximal end channel removably attached to the barrel of the syringe.

[0020] As will be readily understood by those skilled in the art, “joint,” “tip,” “hub,” “screw,” “sponge,” “prong,” “projection,” “wall,” “top,” “side,” “bottom,” and other descriptive terms are used herein for ease of understanding, but are not intended to limit to components that can be used in combination or individually to carry out various embodiments of the embodiments of this disclosure.

[0021] In this specification, the term “medical device” refers to a general medical device having a screw-type or interlocking connection, the connection having a corresponding mating element. For example, a syringe may have, but is not limited to, a male screw-type connection that interlocks releasably with a secondary medical device such as a male Luer connection, such as a catheter or IV line. The screw-type connection includes a lumen that defines a fluid path enclosed by a protruding wall having a threaded means for attachment to the secondary medical device.

[0022] As will be readily apparent to those skilled in the art, “screw,” “taper,” “tab,” “inclined,” “wall,” “top,” “side,” “bottom,” and other descriptive terms are used herein for ease of understanding, but are not intended to limit to components that can be used in combination or individually to carry out various embodiments of the embodiments of this disclosure.

[0023] The examples provided in this description are intended to aid in a comprehensive understanding of the exemplary embodiments of this disclosure. Those skilled in the art will therefore recognize that various modifications and alterations of the embodiments described herein can be made without departing from the scope and spirit of this disclosure. Furthermore, descriptions of well-known functions and structures are omitted for clarity and brevity.

[0024] Exemplary embodiments of the present disclosure provide a cap that can reduce by approximately half the number of device types and logistics currently required in a hospital environment for connecting, capping, and / or sterilizing male and female threaded fluid luer connectors, by including a feature in a single cap or device that allows it to be used with both male and female needleless connectors.

[0025] According to further exemplary implementations of embodiments of the present disclosure, a female thread has a thread pattern that is sized and engages with a standard ISO 594-2 type male fitting, and / or engages with a male thread that is sized and has a thread pattern that engages with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a Q-style fitting.

[0026] In one or more embodiments, the female needleless connector may be selected from the group essentially consisting of needleless connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the needleless connector may be selected from Q-Syte® connector, MaxPlus®, MaxPlus Clear, MaxZero®, UltraSite, Caresite®, InVision-Plus, Safeline®, OneLink, V-Link, ClearLink, NeutraClear®, Clave®, MicroClave®, MicroClave Clear, Neutron®, NanoClave®, Kendall®, Nexus, InVision, Vadsite®, Bionector®, etc.

[0027] In one or more embodiments, the male connector may be an intravenous tube end, a stopcock, or a male locking luer.

[0028] Before describing some exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the configuration or process details set forth in the following description. This disclosure may have other embodiments and may be implemented or performed in a variety of ways.

[0029] The examples provided in this description are intended to aid in a comprehensive understanding of the exemplary embodiments of this disclosure. Those skilled in the art will therefore recognize that various modifications and alterations of the embodiments described herein can be made without departing from the scope and spirit of this disclosure. Furthermore, descriptions of well-known functions and structures are omitted for clarity and brevity.

[0030] Referring to Figures 3-5, a first aspect of the present disclosure relates to a cap 50 having a housing 52 having a housing side wall 54 and a closed upper or end wall 56 at the proximal end of the housing. The distal or bottom end of the housing 52 defines an open bottom 58. A split collar projection 60 projects axially from the closed upper wall 56. As shown, the split collar projection includes a pair of opposing parallel sector-shaped collet fingers 61 (also referred to herein as collet prongs), each having a distally axially oriented projection tip 62, a projection outer wall 64, and an outer wall split thread 66, sized to mate with the corresponding collar thread of a male Luer connector. The outer wall split thread 66 begins at the projection tip 62 and terminates near the upper wall 56.

[0031] Each collet finger / prong 61 defines the inner wall 68 of the projection and the cantilevered split flange 70. Each split flange 70 has a flange root 71 coupled to its corresponding inner wall 68 of the projection, from which a distal axial contact surface 72 protrudes, terminating at the flange tip 73. In summary, each flange tip 73 of the split flange 70 is oriented radially inward with respect to the axial centerline of the split collar projection 60, and is generally radially oriented along the inner wall of the projection, between the closed upper wall 60 and the projection tip 62. Two collet finger / prongs 61 are shown in this embodiment of the cap 50, but other embodiments incorporate two or more collet fingers.

[0032] Collectively, the collet finger / prong 61 defines a generally cylindrical projecting outer wall 64 having a circular planar shape centered on an axial centerline and radially outward-facing male Luer-engageable outer split thread 66, as shown in Figure 5. Each inner wall 68 of the collet finger 61 defines a radially inward-facing female Luer-engageable inner split thread 74, beginning at the projection tip 62 and ending in front of the split flange 70 adjacent to the upper wall 56. Collectively, the inner wall 68 of the projection defines an inner cylindrical second cavity 76 and an outer annular first cavity 78. In other embodiments, the cap has projections comprising any number of identical and / or different collet finger / prongs (in any dimensional characteristics such as length, width, thickness, or shape), as long as the projections are configured to engage with an inner split thread on the inner surface for a female connector and with an outer split thread on the outer surface for a male connector.

[0033] A cylindrical absorbent material 80 having a proximal axial surface 82 is inserted into an inner second cavity 76 and held in place by radial compression and frictional engagement with a female Luer-engageable split screw 74. The absorbent material 80 abuts against each axial contact surface 72 of the split flange 70. In one or more embodiments, the absorbent material 80 is a nonwoven material, a foam, or a sponge. In certain embodiments, the foam is a polyurethane foam. In certain embodiments, the absorbent material 80 is in the form of a foam stopper. In yet another exemplary embodiment, the disinfectant member such as the absorbent material 80 is in the form of an IPA-soaked sponge and / or sponge.

[0034] The cap 50 can disinfect the Luer connector by incorporating a disinfectant or antimicrobial agent into the absorbent material 80. In some embodiments, the disinfectant or antimicrobial agent is directly contained in the inner cylindrical cavity 76 and / or the outer annular cavity 78. In other embodiments, the disinfectant or antimicrobial agent is absorbed into a sponge or foam material containing the absorbent material 80. The cap 50 is adapted to interact with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent includes alcohol or variations of chlorhexidine. In one or more embodiments, the disinfectant or antibacterial agent is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antibacterial agent is a fluid or a gel.

[0035] 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 come into contact with a disinfectant or antimicrobial agent, thereby disinfecting the connector. Therefore, the compression of the absorbent material 80 while the cap 50 is coupled to the Luer connector disinfects the connector.

[0036] Referring to Figures 6 to 8, the embodiment of the cap 50 enhances the alignment, thread engagement, and disinfection of either a male or female threaded Luer connector 90 or 110 when it is coupled together and compresses the absorbent material (e.g., sponge) 80. Figure 6 shows the axially oriented insertion force F when the cap 50 is attached to the male or female Luer connector. C This shows the approximate structural deflection of the split collar projection 60 in response to the compression. When the sponge 80 is compressed, an insertion force F is applied to the distal axial contact surfaces 72 of the opposing split flanges 70. C However, the torque moment T around the flange root 71 F Add the applied torque moment T. F This deflects the flange 70 and its flange tip 73 radially outward, as indicated by the torque moment arrow. In response, the collet finger / prong 61 deflects the flange tip 73, as indicated by the deflection arrow D. P As shown, the fingers are deflected radially inward, and the applied insertion force F causes each of their distal tips 62 to be radially closer to the axial centerline of the cap 50 compared to when the collet fingers are relaxed. C Deflection arrow D without accompanying P As shown, it deflects radially inward. Deflection D of collet finger / prong 61 in embodiment of cap 50 P The advantages are shown in the luer connector engagement examples in Figures 7 and 8.

[0037] In FIG. 7, cap 50 is applied to an exemplary threaded male Luer IV connector 90. The IV connector 90 incorporates a male Luer tip 92 having a proximal male tip 94 with a Luer taper, a circumferential outer surface 97, and a curved roll-over edge 96 that blends into the lumen 98. The collar 99 of the IV connector 90 defines an inner surface 100 of the collar with male Luer threads 102 and terminates at the collar proximal end 104. While the cap 50 is secured to the IV connector 90, the proximal male tip 94 of the connector contacts the distal axial surface 82 of the disinfection sponge 80 before contacting between the distal tip 62 of the cap and the collar proximal end 104 of the connector. This then applies an axial insertion force F C load to the sponge 80, compressing the sponge. The compressed sponge transfers the axial load to the cantilevered split flange 70, deflecting the distal tips 62 of the collet fingers / prongs 61 and their outer wall threads 66 radially inwardly toward the axial centerline of the cap 50. As a result of the compression of the sponge 80, when the distal tips 62 of the collet fingers / prongs 61 and their outer wall threads 66 bend inwardly, they provide a radial engagement clearance between themselves and the corresponding inner surface 100 and the proximal end 104 of the collar 99 prior to the contact engagement of the cap outer wall threads 66 and the male Luer threads 102 of the IV connector. The deflection of the collet fingers 61 improves the engagement tolerance between the currently engagable outer wall split threads 66 of the cap 50 and the male Luer threads 102 of the IV connector 90 and / or reduces an interference fit.

[0038] In addition to improving engagement tolerance and / or reducing interference fit of the cap 50 and male IV connector 90 for enhanced component mating, the cap embodiments disclosed herein also enhance disinfection of the tapered male luer portion 92 during cap engagement. As the male IV connector is inserted into the cap 50 and the insertion force FC deflects the split flange 70, the distal axial surface 82 of the compressed sponge 80 biases the proximal tip 94, rollover edge 96, and upper adjacent circumferential outer surface 97 of the tapered male luer portion 92, scrubbing them with disinfectant held within the sponge. As the cap 50 and male IV connector 90 are screwed together, an additional circular scrubbing action further disinfects the tapered male luer portion 92.

[0039] In Figure 8, the cap 50 is applied to an exemplary threaded female Luer IV connector 110. The female IV connector 110 has a tapered female portion, a side wall 114, and a proximal tip 116 for complementary engagement with a corresponding male Luer connector. The outer surface 118 of the side wall 114 defines the female Luer thread 120. When the cap 50 is applied to the female IV connector 110, the mating inner wall split threads 74 of the cap and the threads 120 of the female IV connector come into contact and engage with each other before the proximal tip 116 of the female IV connector contacts the distal axial surface 82 of the disinfectant sponge. Thus, the opposing split flanges 70 and collet fingers 61 are relaxed, allowing the split threads 74 of the cap 50 and the female IV connector threads 120 to mate with each other without significant friction or radial engagement interference. When the cap 50 is tightened and the sponge 80 is compressed, the distal and proximal tips 62 of the collet finger / prong 61 deflect inward toward the axial centerline of the cap, radially compressing the mating split thread 74 and the female IV connector thread 120 toward each other, thereby tightening the cap and the female IV connector grip.

[0040] Therefore, the same universal cap 50 of this disclosure having a split collar projection 60 facilitates cap alignment, engagement, and enhanced disinfection of male Luer connectors such as the male IV connector 90 in Figure 7, and also enhances disinfection and engagement of female Luer connectors such as the female IV connector 110 in Figure 8. The universality of the auto-aligning cap 50 provides a single disinfection and sealing solution for both male and female Luer fittings. This reduces inventory costs, and clinicians only need to be familiar with one type of cap for all their sealing and Luer fitting disinfection needs.

[0041] In various embodiments, the cap 50 of the present disclosure is constructed from one of several types of plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other injection-molded medical-grade plastic material used in medical devices. In one or more embodiments, the cap 50 comprises polypropylene or polyethylene material. In some embodiments, the cap 50 is a monolithic structure. In some embodiments, the cap 50 is a monolithic structure made of medical-grade plastic. In some embodiments, the cap 50 is formed by an injection molding process. In some embodiments, the housing sidewalls 54 and closed top or end wall 56 of the housing 52 are a single structure, and the split collar projection 60 including the collet finger / prong 61 is a separate single structure, and both single components are fastened to each other by heat or friction welding, adhesive or mechanical staking / fixing.

[0042] (Embodiment) Embodiment (a): A cap for coupling to a male or female Luer medical connector, comprising a housing having a first cavity formed in the upper wall and the outer side wall of the housing, and an axial centerline defining the open bottom of the housing, and a split collar projection in the first cavity coupled to the upper wall, circumscribing the axial centerline and projecting toward the open bottom, wherein each projection comprises a distal projection tip, a projection outer wall surface sized to engage with the corresponding collar thread of a male Luer connector and defining a suitable outer wall split thread, and an inner wall surface sized to engage with the corresponding thread of a female Luer connector and defining a suitable inner wall split thread, each The inner wall split thread and the respective outer wall split threads are coupled to the inner wall surface of each collet prong by a flange root, the inner split thread and the respective outer wall split threads having a cantilever-shaped distal axial contact surface that is generally oriented radially inward with respect to the axial centerline of the housing and terminates at the radially opposite flange tip of the other flange tip, A cap comprising: an absorbent material inserted between each of the split flanges and the open bottom of the housing in the second cavity, the absorbent material being compressed as the male or female luer connector advances in the second cavity, thereby biasing the split flange toward the upper wall of the housing, the absorbent material causing the now-biased split flange to deflect the projection tips of each of its collets inward toward the axial centerline.

[0043] Embodiment (b): The cap according to Embodiment (a), wherein when the tapered male tip of a threaded male luer connector is inserted into and advanced into a second cavity and the absorbent material is compressed, the projection tip of each prong is deflected radially inward away from the proximal end and inner collar surface of the male luer connector collar, thereby avoiding interference contact between the prong tips and the collar.

[0044] Embodiment (c): The cap according to Embodiment (b), wherein the adjacent proximal tip, rollover edge, and circumferential outer surface of the tapered male tip of the threaded male luer connector compress the absorbent material as insertion into the second cavity and screwing in progress, and the absorbent material rubs against the proximal tip, rollover edge, and circumferential outer surface during tightening of the threads of the cap and the male luer connector, respectively.

[0045] Embodiment (d): The cap according to Embodiment (a), wherein a threaded female Luer connector is inserted into the second cavity and screwed forward, compressing the absorbent material, causing the tip of each prong projection to deflect radially inward, bringing its inner wall split threads into contact with corresponding threads formed on the outer side wall of the female Luer connector.

[0046] Embodiment (e): The cap according to Embodiment (d), wherein the absorbent material rubs against the surface of the tapered female portion of the female Luer connector while the threads of the cap and the female Luer connector are being tightened.

[0047] Embodiment (f): The cap according to Embodiment (a), further comprising a disinfectant or antimicrobial agent held within an absorbent material.

[0048] Embodiment (g): The cap according to Embodiment (f), wherein the disinfectant or antibacterial agent is selected from the group essentially consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0049] Embodiment (h): The cap according to Embodiment (g), wherein the disinfectant or antimicrobial agent is a fluid or gel.

[0050] Embodiment (i): The cap according to Embodiment (f), wherein the disinfectant or antimicrobial agent is a fluid or gel.

[0051] Embodiment (j): The cap according to Embodiment (a), wherein the absorbent material is a foam, polyurethane foam, or sponge.

[0052] Embodiment (k): The cap according to Embodiment (a), wherein the split collar projection includes a pair of collet prongs and their respective split flanges.

[0053] Embodiment (l): The cap is the cap according to Embodiment (k), which includes a monolithic structure.

[0054] Embodiment (m): The cap according to Embodiment (l), wherein the monolithic structure is formed by injection molding the cap.

[0055] Throughout this Specification, any reference to “one embodiment,” “a particular embodiment,” “various embodiments,” “one or more embodiments,” or “a particular embodiment” means that any particular feature, structure, material, or characteristic described in relation to an embodiment is included in at least one embodiment of this Disclosure. That is, the appearance of phrases such as “in one or more embodiments,” “in a particular embodiment,” “in various embodiments,” “in one embodiment,” or “in an embodiment” in various places throughout this Specification does not necessarily refer to the same embodiment of this Disclosure. Furthermore, any particular feature, structure, material, or characteristic may be combined in any suitable manner in one or more embodiments.

[0056] While this disclosure is described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the invention without departing from the spirit and scope. Accordingly, this disclosure is intended to include modifications and variations that fall within the scope of the appended claims and their equivalents.

Claims

1. A cap for coupling to a male or female Luer medical connector, A housing having an axial center line defining a first cavity formed in the upper wall and the outer side wall of the housing, and an open bottom of the housing, A split collar projection within the first cavity, coupled to the upper wall, tangent to the axial centerline, and projecting toward the open bottom, wherein the projection has opposing parallel sector-shaped collet prongs, each prong having a distal projection tip, an outer wall surface of the projection defining an outer wall split thread sized and adapted to engage with a corresponding collar thread of a male luer connector, and an inner wall surface defining an inner wall split thread sized and adapted to engage with a corresponding thread of a female luer connector, wherein each of the inner wall split threads and each of the outer wall split threads has the respective inner surfaces of the collet prongs defining a second cavity sized and adapted to receive a male or female luer connector, starting at the distal projection tip and ending near the upper wall, A split flange coupled to the inner wall surface of each collet prong by a flange root, located between the inner split thread and the upper wall, each separate split flange having a cantilever-shaped distal axial contact surface, generally oriented radially inward with respect to the axial centerline of the housing and terminating at the radially opposite flange tip of the other flange tip, A cap comprising: an absorbent material inserted between each of the split flanges and the open bottom of the housing within the second cavity, wherein the absorbent material is compressed as the male or female luer connector advances within the second cavity, biasing the split flange toward the upper wall of the housing, and the now-biased split flange deflects the tips of the projections of each collet inward toward the axial centerline.

2. The cap according to claim 1, wherein when the tapered female tip of the threaded male luer connector is inserted into and advanced into the second cavity and the absorbent material is compressed, the protruding tip of each prong is deflected radially inward away from the proximal end and inner collar surface of the male luer connector, thereby avoiding interference contact between the prong tip and the collar.

3. The cap according to claim 2, wherein the adjacent proximal tip, rollover edge, and circumferential outer surface of the tapered male tip of the threaded male luer connector compress the absorbent material when it is inserted into and screwed forward into the second cavity, and the absorbent material rubs against the proximal tip, rollover edge, and circumferential outer surface during tightening of the respective threads of the cap and the male luer connector.

4. The cap according to claim 1, wherein when a threaded female luer connector is inserted into the second cavity and screwed forward, and the absorbent material is compressed, the tip of each prong deflects radially inward, biasing its inner wall split threads to contact the corresponding threads formed on the outer side wall of the female luer connector.

5. The cap according to claim 4, wherein the absorbent material rubs against the surface of the tapered female portion of the female luer connector while the cap and the respective threads of the female luer connector are being tightened.

6. The cap according to claim 1, further comprising a disinfectant or antibacterial agent held within the absorbent material.

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

8. The cap according to claim 7, wherein the disinfectant or antibacterial agent is a fluid or a gel.

9. The cap according to claim 6, wherein the disinfectant or antibacterial agent is a fluid or a gel.

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

11. The cap according to claim 1, wherein the split collar projection comprises a pair of collet prongs and their respective split flanges.

12. The cap according to claim 11, wherein the cap has a monolithic structure.

13. The cap according to claim 12, wherein the monolithic structure of the cap is formed by injection molding the cap.

Images