Cap for coupling to male or female luer medical connector

Abstract

The present application relates to a cap for coupling to a male or female luer medical connector. 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 cleaved collar protrusion protrudes 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 the tip of the protrusion. An inner wall of each collet finger defines a split flange cantilever, respectively. The inner wall and the outer wall of each collet finger define a split thread, respectively dimensioned to mate with a corresponding thread of a Luer connector. An antimicrobial infused absorbent material is oriented between the breach flange and the cap bottom. When the cap is secured to the Luer connector, the absorbent material compresses the offset cleat flange and deflects the collet finger / fork, thereby making the cap easier to align and engage with the Luer medical connector and enhancing connector disinfection.

Description

Technical Field

[0001] The present disclosure relates generally to a device for disinfecting and sterilizing access ports having, for example, male and / or female Luer fittings, and in particular to a disinfecting and sterilizing device capable of accommodating multiple types of Luer connectors. In general, exemplary embodiments of the present disclosure relate to the field of threaded fittings, including medical caps and medical sterilization caps, and in particular to universal application 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 classifications of VADs: peripheral catheters and central venous catheters. When connected to a VAD to deliver fluids or pharmaceuticals, bacteria and other microorganisms may enter the patient's vascular system from the access hub and ports / valves. Each access hub (or port / valve or connection) may carry some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be 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, needleless connectors are often used to close the system when an intravenous catheter is in use and are then subsequently 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 state that they should be "constantly and thoroughly disinfected with alcohol, iodine, or a chlorhexidine gluconate / alcohol mixture before each access." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that may survive on the surface and may cause a variety of catheter-related complications, including CRBSI. Nurses typically accomplish this disinfection task by performing a procedure called a "scrub hub" using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is often low. In addition to the lack of compliance with the "scrub hub," clinician interviews also noted that there was often variation in scrub times, drying times, and the number of times needleless connectors were scrubbed.

[0006] Throughout the procedural sequence, there are numerous risks of exposure or contamination associated with the transmission of microorganisms that could cause CRBSI. Contamination can occur during medication mixing, attachment of cannulas, and insertion of access hubs. Because the procedure to connect to a VAD is so common and simple, the risks associated with accessing a patient’s vascular system are often overlooked. Currently, the risk to hospitals and patients is largely dependent on the diligence of the clinician making the connection, which is largely uncontrollable.

[0007] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) and hemodialysis tubing use different designs and are therefore limited to the type of connector to which the cap can be attached. Currently, there are male sterilization cap devices for sterilizing ISO594-2 type female threaded fluid Luer connectors, and there are female sterilization cap devices for sterilizing ISO594-2 type 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 unique universal disinfection cap device, the features of which allow it to be mated 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 1 and 2, the cap 10 includes a housing 12 including an inner sidewall 14 and 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 (which may be substantially cylindrical and coaxial with the inner sidewall 14), the projection having an inner surface 24 defining a second cavity 26 and a tapered outer surface 28 defining an outer portion of the first cavity 18. The projection 22 includes internal threads 30 on its inner surface 24 for engaging a female Luer connector, and the outer surface 28 is tapered, sized and adapted to engage a male Luer connector in a press-fit connection sufficient to interlock with a mating feature of the male needleless connector. The protrusion 22 is shown to include two prongs 32 separated by a cutout or gap 34 and extending substantially in a proximal direction from the distal wall 16 .

[0009] 2, in one or more embodiments, an absorbent material 36 is disposed in a chamber defined by the first cavity 18 and the second cavity 26, and the absorbent material is radially compressed by the internal thread 30 on the inner surface 24 of the protrusion 22 to retain the absorbent material 36 in the first cavity 18 and the second cavity 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 in the second cavity 26, and the outer cylindrical material 40 is disposed in the first cavity 18, and the outer cylindrical material 40 is a ring having an orifice and an orifice diameter, and the orifice diameter is substantially equal to the outer diameter of the protrusion 22, so that the outer cylindrical material 40 is disposed only in the first cavity 18, in contact with the inner sidewall 14 of the housing 12 and the outer surface 28 of the protrusion 22. The absorbent material 36 , the inner cylindrical material 38 , and the outer cylindrical material 40 abut the axial end wall 16 when placed within the first cavity 18 or the second cavity 24 . Utility Model Content

[0010] 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. The universal cap embodiments disclosed herein facilitate easier alignment and engagement 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 bottom of the opening, and comprises at least one pair of oppositely parallel, fan-shaped, collet fingers / forks terminating at the tip of the protrusion. Some embodiments of the cap have more than two collet fingers / forks. The inner wall of each collet finger / fork of the split collar protrusion defines a split flange cantilever, respectively. Each split flange has a flange root, which is connected to its corresponding inner wall, from which an axial contact surface protrudes, and the axial contact surface terminates at the flange tip. In general, the corresponding flange tip of the split flange is in a radially inward relative orientation relative to the axial centerline of the split collar protrusion, and is usually oriented axially along the protrusion inner wall between the closed end wall and the protrusion tip. Although two chuck fingers / forks 61 are shown in the embodiment of the cap 50, other embodiments include more than two chuck fingers / forks. The inner wall and outer wall of each chuck finger / fork define the split internal thread and external thread respectively, which are designed and sized to be engaged with the corresponding corresponding female and male thread pairing of the Luer connector. The absorbent material is oriented between the split flange and the bottom of the cap. In certain embodiments, the absorbent material is injected with an antimicrobial agent. When the cap is fixed on the Luer connector, the compression of the absorbent material biases the split flange toward the cap end wall, and deflects the tip of the chuck finger / fork radially inward toward the axial centerline of the cap, so that the cap is aligned and engaged with the corresponding connector, and enhances the disinfection of the connector. The exemplary caps disclosed herein provide a mechanical barrier for medical connectors and retain antimicrobial agents for disinfection. The caps disclosed herein allow healthcare professionals to simplify 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 connecting to a male or female Luer medical connector. The cap includes a housing having an axial centerline. The cap defines a first cavity formed in the housing top wall and the circumscribing housing sidewall. The cavity is connected to the open bottom of the housing. A split collar protrusion is oriented in the first cavity, connected to the top wall, circumscribing the axial centerline and protruding toward the open bottom. The protrusion has a plurality of opposite, parallel, fan-shaped collet prongs, also referred to as collet fingers. Each corresponding collet finger / fork has a distal protrusion tip and a protrusion outer wall surface, the protrusion outer wall surface defines an outer wall split thread, and the outer wall split thread is designed to be sized and suitable for mating with the corresponding collar thread of the male Luer connector. Each corresponding collet finger / fork also has an inner wall surface defining an inner wall split thread, which is designed to be sized and suitable for mating with the corresponding thread of the female Luer connector. The corresponding inner wall split thread and the corresponding outer wall split thread start at the distal protrusion tip and terminate immediately adjacent to the top wall. The corresponding inner surface of the collet fork defines a second cavity, which is designed to be sized and suitable for receiving a male or female Luer connector. The split flange is connected to the inner wall surface of each corresponding collet fork between the internal split thread and the top wall by the flange root. Each separate, corresponding split flange has a cantilevered distal axial contact surface, which is usually radially inwardly oriented relative to the axial centerline of the housing and terminates at a flange tip radially opposite to the other flange tips. The absorbent is inserted between the corresponding split flange and the open bottom of the housing in the second cavity. The absorbent is compressed during the advancement of the male or female Luer connector in the second cavity and the split flange is biased toward the top wall of the housing. The now biased split flange deflects the protrusion tip of its corresponding collet fork inwardly 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 present disclosure are set forth in the following description and the appended claims.

[0013] In one embodiment, the present application is directed to a cap for coupling to a male or female Luer medical connector, characterized by comprising:

[0014] a housing having an axial centerline, the housing defining a first cavity formed within a housing top wall and surrounding housing side walls and an open bottom of the housing;

[0015] a split collar protrusion within the first cavity, the split collar protrusion coupled to the top wall, surrounding the axial centerline and protruding toward the open bottom, the protrusion having a plurality of opposed, parallel, scalloped collet forks, each fork having: a distal protrusion tip, a protrusion outer wall surface and an inner wall surface, the protrusion outer wall surface defining an outer wall split thread 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 sized and adapted to mate with a corresponding thread of a female Luer connector, the respective inner wall split threads and respective outer wall split threads starting from the distal protrusion tip and terminating proximate to the top wall, the respective inner surfaces of the collet forks defining a second cavity sized and adapted to receive a male or female Luer connector:

[0016] a split flange coupled to the inner wall surface of each respective collet fork via a flange root intermediate the internal split threads and the top wall, each separate, respective split flange having a cantilevered distal axial contact surface oriented generally radially inwardly relative to the axial centerline of the housing and terminating in a flange tip radially opposite the other flange tip; and

[0017] an absorbent material interposed within the second cavity between the corresponding split flange and the open bottom of the housing, the absorbent material compressing during advancement of a male or female Luer connector within the second cavity 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.

[0018] In one embodiment, when the tapered male tip of the threaded male Luer connector is inserted and advanced into the second cavity and compresses the absorbent material, the protruding tip 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 tip and the collar.

[0019] In one embodiment, the adjoining proximal tip, turned edge, and circumferential outer surface of the tapered male tip of the threaded male Luer connector compress 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 outer surface during tightening of the cap and the corresponding threads of the male Luer connector.

[0020] In one embodiment, when a threaded female Luer connector is inserted and threadedly advanced into the second cavity and the absorbent material is compressed, the protruding tip 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.

[0021] In one embodiment, 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.

[0022] In one embodiment, the cap further comprises a disinfectant or antimicrobial agent retained within the absorbent material.

[0023] In one embodiment, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0024] In one embodiment, the disinfectant or antimicrobial agent is a fluid or a gel.

[0025] In one embodiment, the disinfectant or antimicrobial agent is a fluid or a gel.

[0026] In one embodiment, the absorbent material is foam or polyurethane foam or sponge.

[0027] In one embodiment, the split collar protrusion includes a pair of collet tines and corresponding split flanges.

[0028] In one embodiment, the cap comprises a monolithic structure.

[0029] In one embodiment, the monolithic structure of the cap is formed by injection molding the cap. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Exemplary embodiments of the present disclosure are further described in the following detailed description in conjunction with the accompanying drawings, in which:

[0031] FIG. 1 is an isometric view of one embodiment of a universal cap for coupling to either a male or female Luer connector, corresponding to the view of U.S. Pat. No. 11,511,100. Figure 7 ;

[0032] FIG. 2 is an axial cross-sectional view of the universal cap of FIG. 1 , which corresponds to FIG. 10 of U.S. Patent No. 11,511,100;

[0033] Figure 3 is an exploded isometric view of one embodiment of a universal cap of the present disclosure for coupling to either a male Luer connector or a female Luer connector;

[0034] Figure 4 yes Figure 3 An axial cross-sectional view of a universal cap;

[0035] Figure 5 yes Figure 3 A bottom plan view of a universal cap;

[0036] Figure 6 is shown in the corresponding Figure 4 The compressive force F applied to the universal cap of the present disclosure is C The resulting torque T F and the radially inwardly directed deflection D of the cap protrusion P Schematic force application diagram of;

[0037] Figure 7 is an axial cross-sectional view of the universal cap of the present disclosure engaging a male Luer connector; and

[0038] Figure 8 is an axial cross-sectional view of the universal cap of the present disclosure engaging a female Luer connector.

[0039] 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

[0040] 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 threaded male Luer connectors and female Luer connectors. The universal cap embodiment disclosed herein facilitates the cap to be more easily aligned and engaged with a threaded male or female Luer medical connector, and enhances connector sterilization. The split collar protrusion protrudes axially from the closed end wall of the cap toward the bottom of the opening, and comprises at least one pair of relative parallel, fan-shaped, collet fingers / forks terminating at the tip of the protrusion. The inner wall of each collet finger defines a split flange cantilever, respectively. The inner wall and outer wall of each collet finger define a split thread, which is designed to be engaged with the corresponding corresponding thread pairing of the Luer connector, respectively. The 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 secured 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 axial centerline of the cap to facilitate alignment and engagement of the cap with the connector and enhance 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 healthcare professionals to simplify the disinfection process by simplifying the cap / connector engagement while disinfecting the connector.

[0041] In the present disclosure, where generally applicable, the convention is generally followed where the distal end of the 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 personnel. Thus, with respect to the universal cap disclosed herein, the open end of the cap that connects to the 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.

[0042] 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.

[0043] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way to attach syringes, catheters, hubbed needles, IV tubes, etc. to each other. A Luer connector consists of a male and female interlocking tube that tapers slightly to better hold together, even if it is just a simple press / twist fit. Luer connectors may optionally include an additional threaded outer rim to make them more secure. The male end of a Luer connector is typically associated with a flush syringe and can be interlocked and connected to a 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 central channel for fluid communication from the chamber of the syringe's barrel to the hub of the VAD. The Luer connector also has a distal channel that releasably attaches the Luer connector to the hub of the VAD, and a proximal channel that releasably attaches the Luer connector to the syringe's barrel.

[0044] As will be readily appreciated by those skilled in the relevant art, although descriptive terms such as "lock," "tip," "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.

[0045] As used herein, the term "medical device" refers to a common medical device having a threaded or interlocking connection with a corresponding mating element. 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 of a catheter, IV tubing, and the like. The threaded connection may include an inner cavity defining a fluid path surrounded by a protruding wall having a threaded arrangement for attachment to the secondary medical device.

[0046] As will be readily appreciated 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 the various aspects of the embodiments of the present disclosure.

[0047] The contents of the examples in this specification are provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, those of ordinary skill in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Moreover, for the sake of clarity and brevity, descriptions of well-known functions and configurations are omitted.

[0048] Exemplary embodiments of the present disclosure provide a cap that can reduce by approximately half the number of device types and logistics currently required to connect, cap, and / or sterilize 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.

[0049] According to yet another exemplary implementation of an embodiment of the present disclosure, the female thread is sized and has a thread pattern to engage with a standard ISO594-2 type male fitting and / or male thread, which is sized and has a thread pattern to engage with a standard ISO594-2 type female fitting. An example of an ISO594-2 type fitting is a Q-type fitting.

[0050] In one or more embodiments, the female needleless connector can be selected from the group consisting 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 Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, Micro ClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0051] In one or more embodiments, the male connector can be an IV tubing tip, a stopcock, or a male Luer lock.

[0052] 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 processing steps set forth in the following description. The present disclosure is capable of other embodiments or can be practiced or carried out in various ways.

[0053] The contents illustrated in this specification are provided to help fully understand the exemplary embodiments of the present disclosure. Therefore, those of ordinary skill 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. Moreover, for the sake of clarity and brevity, descriptions of well-known functions and configurations are omitted.

[0054] refer to Figure 3-Figure 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 wall or end wall 56 on the proximal end of the housing. The distal end or bottom end of the housing 52 defines an open bottom 58. A split collar projection 60 protrudes axially from the closed top wall 56. As shown, the split collar projection comprises a pair of parallel fan-shaped chuck fingers 61 (also referred to herein as chuck forks) relative to each other, each chuck finger having a distal axially oriented projection tip 62, a projection outer wall 64, and an outer wall split thread 66, the dimensions of which are designed to engage with the corresponding collar thread of a male Luer connector. The outer wall split thread 66 starts at the projection tip 62 and terminates adjacent to the top wall 56.

[0055] Each collet finger / fork 61 defines a projection inner wall 68 and a cantilevered split flange 70. Each split flange 70 has a flange root 71 coupled to its corresponding projection inner wall 68 from which it projects a distal axial contact surface 72 terminating in a flange tip 73. In general, each flange tip 73 of the split flange 70 is oriented radially inwardly relative to the axial centerline of the split collar projection 60 and is generally oriented radially along the projection inner wall intermediate the closed top wall 60 and the projection tip 62. While two collet fingers / forks 61 are shown in the embodiment of the cap 50, other embodiments include more than two collet fingers.

[0056] Generally speaking, the collet fingers / forks 61 define a circular plan view about the axial centerline, as shown in FIG. Figure 5 6, and a generally cylindrical protrusion outer wall 64 having radially outwardly facing, male Luer-engageable outer split threads 66. The inner wall 68 of each collet finger 61 defines radially inwardly facing, female Luer-engageable inner split threads 74 that begin at the protrusion tip 62 and terminate immediately before the split flange 70 adjacent the top wall 56. 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 the same and / or different (in any dimensional feature, such as length, width, thickness or shape) collet fingers / forks, as long as the protrusion is configured to engage a female connector with inner split threads on its inner surface and engage a male connector with outer split threads on its outer surface.

[0057] A cylindrical absorbent material 80 having a proximal axial surface 82 is inserted into the interior second cavity 76 and is retained by radial compression and frictional engagement with the female Luer-engageable split threads 74. The absorbent material 80 abuts the axial contact surface 72 of each split flange 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 another exemplary embodiment, one or more disinfecting members (such as the absorbent material 80) are in the form of an IPA soaked sponge and / or sponge.

[0058] The cap 50 can sterilize the Luer connector by integrating a disinfectant or antimicrobial agent in the absorbent material 80. In some embodiments, the disinfectant or antimicrobial agent is contained directly 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 compatible with interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent includes a variant of alcohol or 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, povidoneiodine, 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.

[0059] 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 sterilizes the connector when the cap 50 is coupled to the Luer connector.

[0060] refer to Figure 6-Figure 8 , embodiments of the cap 50 enhance alignment, threaded engagement, and sterilization of the male threaded Luer connector 90 or the female threaded Luer connector 110 as they couple 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 secured to a male or female Luer connector. C When the sponge 80 is compressed, the insertion force F C Abutting against the respective distal axial contact surface 72 of the opposing 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 tip 73 are biased and deflected in the radially outward direction, as shown by the moment arrow. Under the reaction, the clamp finger / fork 61 is deflected as shown by the deflection arrow D P The chuck fingers are shown deflected radially inwardly so that they are in a relaxed state and no insertion force F is applied. 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 illustrated example of Luer connector engagement shows the collet finger / fork 61 deflecting D in the cap 50 embodiment. P Advantages.

[0061] exist Figure 7 , the cap 50 is applied to an exemplary threaded male Luer IV connector 90. The IV connector 90 includes a male Luer tip 92 having an adjacent male tip 94 having a curved rollover edge 96 that blends into the Luer tapered circumferential outer surface 97 and the inner cavity 98. The collar 99 of the IV connector 90 defines a collar inner surface 100 having male Luer threads 102 and terminates in a collar proximal edge 104. During the securing of the cap 50 to the IV connector 90, the proximal male tip 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 tip 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, thereby deflecting the distal tips 62 of the collet fingers / forks 61 and their outer wall threads 66 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 bend inward, providing radial engagement clearance between themselves and the corresponding inner surfaces 100 and the proximal edge 104 of the collar 99 before the 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 the engagement tolerance 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.

[0062] In addition to improving the engagement tolerances of the cap 50 and the male IV connector 90 and / or reducing interference fit to enhance 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 tip 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 in the sponge. When the cap 50 and the male IV connector 90 are screwed together, the additional circular scrubbing action further disinfects the tapered male Luer portion 92.

[0063] exist 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 sidewall 114 and a proximal tip 116 for complementary engagement with a corresponding male Luer connector. The outer surface 118 of the sidewall 114 defines a female Luer thread 120. When the cap 50 is applied to the female IV connector 110, the corresponding mating inner 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 tip 116 of the female IV connector contacts the distal axial surface 82 of the disinfectant sponge. Therefore, the relative split flange 70 and the collet finger 61 are in a relaxed state, thereby 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 clamp 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.

[0064] Thus, the same universal cap 50 of the present disclosure with its split collar protrusion 60 facilitates easier cap alignment, connection with male Luer connectors such as Figure 7 The invention also provides improved engagement and enhanced sterilization of male IV connectors 90, while also enhancing the engagement of female Luer connectors (such as Figure 8 The universality of the self-aligning cap 50 provides a single sterilization and sealing solution for both male and female Luer fittings. This reduces inventory expenses and requires clinicians to be familiar with only one type of cap to meet all sealing and Luer fitting sterilization needs.

[0065] In various embodiments, the cap 50 of the present disclosure is made of any one of a variety of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, 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 some embodiments, the cap 50 is a single-piece structure. In some embodiments, the cap 50 is a single-piece structure consisting of medical grade plastic. In some embodiments, the cap 50 is formed by injection molding. In some embodiments, the closed top wall or end wall 56 of the housing side wall 54 and the housing 52 is an integral structure, and the split collar protrusion 60 including the clamp finger / fork 61 is a separate, integral structure, and the two integral parts are fixed to each other by heat or friction welding, adhesive or mechanical riveting / fastening.

[0066] References throughout the 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 conjunction with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearance of phrases such as "in one or more embodiments," "in certain embodiments," "in various embodiments," "in one embodiment," or "in an embodiment" in various places throughout the 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.

[0067] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrations of the principles and applications of the present disclosure. It is apparent to those skilled in the art that various modifications and variations may be made to the present disclosure without departing from the spirit or 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 connecting to a male or female Luer medical connector, characterized in that include: a housing having an axial centerline, the housing defining a first cavity formed within a housing top wall and surrounding housing side walls and an open bottom of the housing; a split collar protrusion within the first cavity, the split collar protrusion coupled to the top wall, surrounding the axial centerline and protruding toward the open bottom, the protrusion having a plurality of opposed, parallel, scalloped collet forks, each fork having: a distal protrusion tip, a protrusion outer wall surface and an inner wall surface, the protrusion outer wall surface defining an outer wall split thread 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 sized and adapted to mate with a corresponding thread of a female Luer connector, the respective inner wall split threads and respective outer wall split threads starting from the distal protrusion tip and terminating proximate to the top wall, the respective inner surfaces of the collet forks defining a second cavity sized and adapted to receive a male or female Luer connector: a split flange coupled to the inner wall surface of each respective collet fork at a flange root intermediate the inner 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 the axial centerline of the housing and terminating in a flange tip radially opposite the other flange tip; as well as an absorbent material interposed within the second cavity between the corresponding split flange and the open bottom of the housing, the absorbent material compressing during advancement of a male or female Luer connector within the second cavity 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 according to claim 1, characterized in that When the tapered male tip of the threaded male Luer connector is inserted and advanced into the second cavity and compresses the absorbent material, the protruding tip 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 tip and the collar.

3. The cap according to claim 2, characterized in that The adjoining proximal tip, turned edge and circumferential outer surface of the tapered male tip of the threaded male Luer connector compress 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 outer surface during tightening of the cap and the corresponding threads of the male Luer connector.

4. The cap according to claim 1, characterized in that When the threaded female Luer connector is inserted and threadedly advanced into the second cavity and the absorbent material is compressed, the protruding tip 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 according to claim 4, characterized in that During tightening of the cap and corresponding threads of the female Luer connector, the absorbent material scrubs the surface of the tapered female portion of the female Luer connector.

6. The cap according to claim 1, characterized in that Further included is a disinfectant or antimicrobial agent retained within the absorbent material.

7. The cap according to claim 6, characterized in that The disinfectant or antimicrobial agent is a fluid or a gel.

8. The cap according to claim 1, characterized in that The absorbent material is foam or polyurethane foam or sponge.

9. The cap according to claim 1, characterized in that The split collar protrusion includes a pair of collet tines and corresponding split flanges.

10. The cap according to claim 9, characterized in that The cap comprises a monolithic structure.

11. The cap according to claim 10, characterized in that The one-piece structure of the cap is formed by injection molding the cap.

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