Universal disposable cap for male and female connectors

Abstract

A device for connecting to a medical connector, the device comprising a cap, a container, and a peelable seal. The cap is configured to define a chamber for holding an absorbent material and a disinfectant or antimicrobial agent. The cap comprises one or more threads adapted to engage with a female luer connector. The cap is adapted to engage a male luer connector in a press fit connection. The peelable seal prevents the disinfectant or antimicrobial agent from exiting the chamber.

Description

[0001] This application is a divisional application of the invention patent application entitled "Universal Disposable Cap for Male and Female Connectors", with an international filing date of April 9, 2019, international application number PCT / US2019 / 026534, and national application number 201980033372.5. Technical Field

[0002] This disclosure generally relates to an apparatus for disinfecting and sterilizing access ports with, for example, male and female Luer fittings, and particularly to a disinfection and sterilization apparatus capable of accommodating a variety of connector types. Background Technology

[0003] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. Vascular access devices are generally classified into two types: peripheral catheters and central venous catheters. When connected to a vascular access device to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system through the access interface and port / valve. Each access interface (or port / valve or connector) is associated with a certain risk of spreading catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

[0004] To reduce cases of catheter-related bloodstream infections (CRBSI) and to ensure the proper use and maintenance of vascular access devices, standard practices have been developed that include disinfection and cleaning procedures.

[0005] Sterilization caps have already been added to the guidelines of the Society for Health Care Epidemiology (SHEA), and early indications suggest that caps will also be included in the 2016 Infusion Nurse Standards (INS) guidelines.

[0006] In developed markets, when using intravenous catheters, needle-free connectors are typically used to shut off the system, and then the connectors are used to administer medications or other necessary fluids to the patient via the catheter. Infusion nurse standards of practice recommend the use of needle-free connectors and state that they should be “continuously and thoroughly disinfected with alcohol, iodine tincture, or a combination of chlorhexidine gluconate and alcohol before each use.” Disinfection of the needle-free connector ultimately aims to help reduce bacteria that may survive on the surface and can lead to various catheter-related complications, including the aforementioned catheter-related bloodstream infections. Nurses typically perform this disinfection by “wiping the interface” using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is often very low. In addition to the lack of compliance with “wiping the interface,” interviews with clinicians have revealed discrepancies in wiping time, drying time, and the number of times the needle-free connector is wiped.

[0007] Numerous risks of contact or contamination exist within the series of procedures associated with the spread of microorganisms that can lead to catheter-related bloodstream infections. Contamination can occur during drug mixing, cannulation, and insertion into the access interface. Because the procedures for connecting to vascular access devices are so common and straightforward, the risks associated with access to the patient's vascular system are often overlooked. Currently, the level of care exerted by clinicians performing the connection plays a major role in determining hospital and patient risk, and this level of care is largely uncontrollable.

[0008] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) lines, and hemodialysis lines use different designs and are therefore limited to the types of connectors that can be attached with caps. Consequently, existing sterilization caps are designed to fit only one type of connector and are specific to a particular size and / or shape of connector. Therefore, there is a need for a sterilization device that can accommodate multiple types of connectors to simplify the sterilization process. There is also a need for a sterilization device capable of continuous sterilization for several days. Summary of the Invention

[0009] One aspect of this disclosure relates to a device for connection to a medical connector according to exemplary embodiments of the present disclosure, the device typically including a cap, a container, an absorbent material, a disinfectant or antimicrobial agent, and a removable seal. The cap includes an integral body, a closed end, and an annular wall having a length extending from the closed end to an open end and defining a chamber for containing the absorbent material and the disinfectant or antimicrobial agent. The open end includes a circumferential flange extending radially from the open end, which defines an end face and a mating surface.

[0010] The annular wall of the cover includes an outer wall surface and an inner wall surface. The inner wall surface defines an opening adjacent to the open end. The opening can be sized to receive a male Luer connector, a female Luer connector, and a hemodialysis connector. The male Luer connector frictionally engages the inner wall surface when inserted into the chamber.

[0011] The inner wall surface includes an internal thread adjacent to the closed end. The internal thread is sized to engage the female Luer connector. The absorbent material and the disinfectant or the antimicrobial agent contact the male Luer connector, the female Luer connector, and the hemodialysis connector after the connector is inserted into the open end of the cap.

[0012] The outer wall surface of the cover includes multiple radial protrusions.

[0013] The container includes an annular container wall having a length extending from a closed end to an open end. The container includes an inner container surface and an outer container surface. The container houses the lid. The container includes a plurality of complementary recesses that engage the plurality of radial protrusions.

[0014] The removable seal is provided on the open end of the container to prevent the disinfectant or antimicrobial agent from leaving the chamber.

[0015] In one or more embodiments, the vaginal Luer connector includes a needleless connector, a stopcock valve, or a hemodialysis connector.

[0016] In one or more embodiments, the male connector is an intravenous catheter end.

[0017] In one or more embodiments, the male Luer connector is positioned on the circumferential flange when fully inserted into the chamber.

[0018] In one or more embodiments, the internal thread adjacent to the closed end of the cover extends partially along the length of the inner wall surface of the cover.

[0019] In one or more embodiments, the male Luer connector frictionally engages the inner wall surface in a press-fit manner when inserted into the chamber.

[0020] In one or more embodiments, the size of the opening at the open end adjacent to the inner wall surface of the cover is configured to receive a male Luer connector in a press-fit connection.

[0021] The cover comprises a flexible material. In one or more embodiments, the flexible material comprises a thin polymer or plastic that can be deflected. In one or more embodiments, the flexible material comprises an elastomer.

[0022] The cover comprises a flexible material. In one or more embodiments, the flexible material comprises a thin polymer or plastic that can be deflected. In one or more embodiments, the flexible material comprises an elastomer. In one or more embodiments, the cover is made of a thermoplastic elastomer.

[0023] In one or more embodiments, the annular wall of the cover is truncated conical.

[0024] In one or more embodiments, the annular container wall is truncated conical. The container is made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the container comprises polypropylene or polyethylene material. In one or more embodiments, the outer container surface includes a plurality of gripping members.

[0025] In one or more embodiments, the absorbent material is subjected to radial compression by the internal threads to retain the absorbent material within the chamber. In one or more embodiments, the absorbent material is retained within the chamber without being subjected to radial compression by the internal threads. In one or more embodiments, the absorbent material is a nonwoven material, foam, or sponge. In a particular embodiment, the foam is polyurethane foam.

[0026] In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctylhydroquinone, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanib sulfate, antibiotics, and mixtures thereof. In a particular 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.

[0027] When connected to the female or male Luer connector, the compression of the absorbent material toward the closed end of the chamber allows the connector to come into contact with the disinfectant or antimicrobial agent to disinfect the female or male Luer connector.

[0028] In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peelable backing top. In a particular embodiment, the peelable seal is heat-sealed or inductively sealed to the open end of the container to retain the cap within the container.

[0029] In one or more embodiments, the lid is selectively coupled to the container via a key connection. In a particular embodiment, a recess in the container is selectively coupled to a plurality of radial protrusions of the lid via a key connection.

[0030] In one or more embodiments, the lid is selectively coupled to the container via a sliding fit connection. In a particular embodiment, a plurality of recesses of the container are selectively coupled to a plurality of radial protrusions of the lid via a sliding fit connection.

[0031] In one or more embodiments, the plurality of radial protrusions extend along the entire length of the outer wall surface of the lid, and the plurality of recesses extend along the entire length of the inner container surface. In yet another embodiment, the plurality of radial protrusions extend partially along the length of the outer wall surface of the lid, and the plurality of recesses extend partially along the length of the inner container surface.

[0032] In one or more embodiments, the plurality of radial protrusions and the plurality of recesses are elongated. In one or more embodiments, the plurality of radial protrusions and the plurality of recesses are tapered.

[0033] A second aspect of this disclosure relates to a method for sterilizing a medical connector. The method includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging the inner wall surface upon insertion into the chamber, such that the medical connector contacts the absorbent material and the sterilizing agent or antimicrobial agent.

[0034] A third aspect of this disclosure relates to a component. The component includes means for connecting to a medical connector according to one or more embodiments. In one or more embodiments, the medical connector is selected from male Luer connectors, female Luer connectors, and needle-free connectors. Attached Figure Description

[0035] Figure 1 A top perspective view of a device according to an embodiment of the present disclosure is shown;

[0036] Figure 2 A side view of an apparatus according to an embodiment of the present disclosure is shown;

[0037] Figure 3 A side view of the components of an apparatus according to an embodiment of the present disclosure is shown;

[0038] Figure 4 A side view of the components of an apparatus according to an embodiment of the present disclosure is shown;

[0039] Figure 5 A partial cross-sectional view of an apparatus according to an embodiment of the present disclosure is shown;

[0040] Figure 6 A partial sectional view is shown, which shows Figure 1 The connection between the device and the female Luer connector;

[0041] Figure 7A partial sectional view is shown, which shows Figure 1 The connection between the device and the male Luer connector;

[0042] Figure 8 A partial sectional view is shown, which shows Figure 1 The connection between the device and the pinless connector;

[0043] Figure 9 A partial sectional view is shown, which shows Figure 1 The connection between the device and the pinless connector;

[0044] Figure 10 shows a perspective view of a female Luer connector with a diaphragm according to the prior art;

[0045] Figure 11 shows a perspective view of a female Luer connector with a plug valve according to the prior art;

[0046] Figure 12 shows a perspective view of a male Luer connector according to the prior art; and

[0047] Figure 13 shows a perspective view of a hemodialysis connector according to the prior art. Detailed Implementation

[0048] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or processing steps set forth in the following description. This disclosure can have other embodiments and can be practiced or performed in various ways.

[0049] Embodiments of this disclosure relate to a universal disposable device for connection to a medical connector and for sterilization of the medical connector, wherein the medical connector comprises a male Luer connector and a female Luer connector, and wherein the device comprises an outer cap and an inner Luer connector. The device provides a mechanical barrier for the connector and contains an antimicrobial agent for sterilization. The device of this disclosure enables practitioners to simplify the sterilization process.

[0050] The following definitions are provided for the terms used in this disclosure.

[0051] When used in this document, the terms “a,” “an,” and “the” are used in both singular and plural forms.

[0052] When used in this document, the term “catheter-associated bloodstream infection” or its English equivalent “CRBSI” refers to any infection resulting from the presence of a catheter or intravenous line.

[0053] When used herein, the term "Luer connector" refers to a connecting collar, which is a standard method of attaching syringes, catheters, interfaced needles, intravenous catheters, etc., to each other. A Luer connector includes male and female interlocking tubes that are slightly tapered to better hold them together by even a simple press-fit / torsion fit. Luer connectors may optionally include additional threaded outer edges for added strength. The male end of the Luer connector is typically associated with a flushing syringe and can interlock with and connect to the female end located on a vascular access device (VAD). A Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central channel for fluid communication from the chamber of the syringe barrel to the interface of the vascular access device. The Luer connector also has a distal end channel for releasably attaching the Luer connector to the interface of the vascular access device, and a proximal end channel for releasably attaching the Luer connector to the barrel of the syringe.

[0054] exist Figure 1 and 2 The assembled device is shown in the figure, wherein... Figure 3-5 The components are shown separately. Figure 6-9 This illustration shows a device for engaging a medical connector according to an embodiment of the present disclosure. Figures 10-13 illustrate various medical connectors according to the prior art. Reference Figure 1-5 A device 100 for connection to a medical connector according to exemplary embodiments of the present disclosure typically includes a cap 102, a container 130, an absorbent material 112, a disinfectant or antimicrobial agent, and a removable seal 150. The cap 102 includes an integral body 104, a closed end 106, and an annular wall 108 having a length L extending from the closed end 106 to the open end 109. A The annular wall defines a chamber 110 for containing absorbent material 112 and disinfectant or antimicrobial agent. The open end 109 includes a circumferential flange 114 extending radially from the open end 109 defining the mating surface 116.

[0055] The annular wall 108 of the cover includes an outer wall surface 120 and an inner wall surface 122. The inner wall surface 122 defines an opening 124 adjacent to the open end 109. See also Figure 6-9 The opening 124 can be sized to accommodate male Luer connector 150, female Luer connector 152, and hemodialysis connector. (Reference) Figure 7 The male Luer connector 150 frictionally engages the inner wall surface 122 when inserted into the chamber 110. In one or more embodiments, the female Luer connector (e.g., with a very large diameter and short length) In particular, it can also be joined to the inner wall surface 122 by interference fit / friction fit.

[0056] refer to Figure 6 The inner wall surface 122 includes an internal thread 126 adjacent to the closed end 106. The internal thread 126 is sized to engage the female Luer connector 152. (Reference) Figure 6-9 After the connector is inserted into the open end 109 of the cover 102, absorbent material 112 and disinfectant or antimicrobial agent come into contact with the male connector 150, female connector 152, and hemodialysis connector. In one or more embodiments, the male and female connectors are Luer connectors.

[0057] refer to Figure 3-5 The outer wall surface 120 of the cover 102 includes a plurality of radial protrusions 128.

[0058] Container 130 includes an annular container wall 132 having a container wall length L extending from the closed end 134 of the container to the open end face 136 of the container. C Container 130 includes an inner container surface 138 and an outer container surface 140. Container 130 receives a lid 102. Container 130 includes a plurality of complementary recesses 142 that engage a plurality of radial protrusions 128 of the lid 102. In one or more embodiments, the plurality of complementary recesses 142 engage the plurality of radial protrusions 128 of the lid to facilitate sliding movement between the lid 102 and the container 130 while preventing significant relative rotation of the lid 102 relative to the container 130. When the lid 102 is fully inserted into the container 130, the lid 102 cannot rotate and is locked in place.

[0059] refer to Figure 2-4 A removable seal 150 is provided on the open end face 136 of the container to prevent disinfectant or antimicrobial agent from leaving the chamber 110.

[0060] In one or more embodiments, the female connector may include a needleless connector, a catheter Luer connector, a stopcock valve, or a hemodialysis connector. In one or more embodiments, the needleless connector is selected from Q-Syte connectors, 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.

[0061] In one or more embodiments, the male connector may be an intravenous catheter end or a male Luer lock.

[0062] In one or more embodiments, the male Luer connector 150 is positioned on the circumferential flange 114 when fully inserted into the chamber 110.

[0063] In one or more embodiments, the internal thread 126 adjacent to the closed end 106 of the cover 102 extends partially along the length of the inner wall surface 122 of the cover 102.

[0064] refer to Figure 7 In one or more embodiments, the male Luer connector 150 frictionally engages the inner wall surface 122 in a press-fit manner when inserted into the chamber 110. In one or more embodiments, the female Luer connector (e.g., with a very large diameter and short length) In particular, it can also be joined to the inner wall surface 122 by interference fit / friction fit.

[0065] In one or more embodiments, the opening 124 of the open end 109 adjacent to the inner wall surface 122 of the cover 102 is sized to be adapted for press-fit connection of a receiving male Luer connector.

[0066] The cover comprises a flexible material. In one or more embodiments, the flexible material comprises a thin polymer or plastic that can be deflected. In one or more embodiments, the flexible material comprises an elastomeric material. In one or more embodiments, the elastomeric material of the cover 102 comprises a thermoplastic elastomer.

[0067] In one or more embodiments, the annular wall 108 of the cover 102 is truncated conical.

[0068] In one or more embodiments, the annular container wall 132 is truncated conical. The container 130 is made of any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, ethylene glycol-modified polyethylene terephthalate, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the container 130 comprises polypropylene or polyethylene material. Reference Figure 4 In one or more embodiments, the outer container surface 140 includes a plurality of gripping members 144.

[0069] In one or more embodiments, the absorbent material is subjected to radial compression of the internal threads 126 to retain the absorbent material within the chamber. In one or more embodiments, the absorbent material is retained within the chamber without being subjected to radial compression of the internal threads. In one or more embodiments, the absorbent material is a nonwoven material, foam, or sponge. In a particular embodiment, the foam is polyurethane foam. In a particular embodiment, the absorbent material is in the form of a foam plug.

[0070] When used on a Luer connector, device 100 can achieve disinfection by integrating a disinfectant or antimicrobial agent into the chamber 110 of cover 102. The disinfectant or antimicrobial agent may be contained directly in chamber 110, or it may be absorbed into a sponge or foam material filling chamber 110 of cover 102. Device 100 is designed to be compatible with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may comprise a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctylhydroquinone, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanib sulfate, antibiotics, and mixtures thereof. In a particular 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.

[0071] When connected to the female Luer connector 152 or the male Luer connector 150, the absorbent material 112 compresses toward the closed end 106 of the chamber 110, allowing the connector to come into contact with a disinfectant or antimicrobial agent to disinfect the female Luer connector 152 or the male Luer connector 150.

[0072] In one or more embodiments, a peelable seal 150 may be placed on the mating surface 116 to prevent disinfectant or antimicrobial agent from leaving the chamber 110.

[0073] In one or more embodiments, the peelable seal 150 includes an aluminum or multilayer polymer film peel-off backing top. In a particular embodiment, the peelable seal 150 is sealed to the open end face 136 of the container to retain the cap 102 within the container 130. In one or more embodiments, the peelable seal 150 includes a moisture barrier. In one or more embodiments, the peelable seal is sealed by heat sealing or induction sealing.

[0074] In one or more embodiments, the cap 102 is selectively coupled to the container 130 via a key connection. In a particular embodiment, a recess 142 of the container 130 is selectively coupled to a plurality of radial protrusions 128 of the cap 102 via a key connection.

[0075] In one or more embodiments, the lid 102 is selectively engaged to the container 130 via a sliding fit connection. In a particular embodiment, a plurality of recesses 142 of the container 130 are selectively engaged with a plurality of radial protrusions 128 of the lid 102 via a sliding fit connection.

[0076] In one or more embodiments, a plurality of radial protrusions 128 extend along the entire length of the outer wall surface 120 of the cover 102, and a plurality of recesses 142 extend along the entire length of the inner container surface 138. In yet another embodiment, the plurality of radial protrusions 128 extend partially along the length of the outer wall surface 120 of the cover 102, and the plurality of recesses 142 extend partially along the length of the inner container surface 138.

[0077] In one or more embodiments, the plurality of radial protrusions 128 of the cover 102 and the plurality of recesses 142 of the container 130 are elongated. In one or more embodiments, the plurality of radial protrusions 128 of the cover 102 and the plurality of recesses 142 of the container 130 are tapered.

[0078] In one or more embodiments, the outer wall surface 120 of the cover 102 includes a plurality of gripping members 144.

[0079] Currently available sterilization caps can only sterilize one of three types of Luer connectors: female Luer connectors for needle-free connectors, female Luer connectors for stopcock valves, and male Luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, cap 102 can engage with both male and female Luer connectors, allowing users to clean different types of connectors with a single device. (Reference) Figure 6 When installing the cover 102 onto the female Luer connector, insert the female Luer connector into the chamber 110 and screw it onto the internal thread 126 of the cover 102. See also Figure 7 When the cover 102 is installed onto the male Luer connector, the male Luer connector frictionally engages the inner wall surface 122 upon insertion into the chamber 110. In one or more embodiments, the female Luer connector (e.g., with a very large diameter and short length) Specifically, it can also be engaged with the inner wall surface 122 via an interference fit / friction fit. Therefore, the device 100 of this disclosure can be mounted on both male and female Luer connectors, thereby meeting current needs in the art.

[0080] Referring to Figures 10-13, in one or more embodiments, the cap of the device of this disclosure forms a fluid-impermeable seal with the female Luer connector 200, the male Luer connector 300, or the hemodialysis connector 400. Referring to Figures 10-13, in one or more embodiments, the cap of the device of this disclosure is conical to form a fluid-impermeable seal with the male Luer connector 300. In certain embodiments, the cap conforms to ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) for forming seals with male Luer components.

[0081] In one or more embodiments, the cap of the device disclosed herein has threads having a specific size and pitch to engage a threaded segment of a female connector (such as a female Luer connector). Such connectors are commonly and typically used in medical applications as protective connectors for catheters and other fluid-impermeable devices. In some embodiments, the cap provides a protective cover for the female Luer connector when engaged with it, provided that the threads from the female Luer connector engage the threads of the cap and form a releasable connection with the threads of the cap.

[0082] In some embodiments, the connector includes a needleless injection portion, which may sometimes be referred to as a needleless injection port, interface, valve, or device, or as a needleless passage portion, port, interface, valve, or device, and may include such brands, for example (Available from ICU Medical, Inc.) (Available from Cardinal Health, Inc.) and Q-Syte TM (Available from Becton, Dickinson and Company). In some embodiments, the cap can be attached to any of a variety of different needle-free injection sites, such as those previously listed. In one or more embodiments, after the cap has been attached to the connector, it is not necessary to sterilize the connector (e.g., treat it with an alcohol wipe) before each reattachment to another connector, because the connector will remain uncontaminated when attached to the cap. This use of the cap replaces the standard wiping protocol for cleaning the connector.

[0083] In one or more embodiments, the thread size and pitch of the cap are configured to engage the threads of a male Luer lock connector. For example, the connector may include an end of an intravenous catheter assembly that is separate from the needle-free injection site of the intravenous catheter.

[0084] Other aspects of this disclosure relate to methods and components for sterilizing medical connectors. In one or more embodiments, a method for sterilizing a medical connector includes connecting the device of one or more embodiments to the medical connector, wherein the connection includes frictionally engaging an inner wall surface when inserted into the chamber such that the medical connector comes into contact with an absorbent material and a disinfectant or antimicrobial agent.

[0085] In one or more embodiments, a component includes one or more of the means for connecting to a medical connector. In one or more embodiments, the medical connector is selected from male Luer connectors, female Luer connectors, and pinless connectors.

[0086] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or simply "embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of this disclosure. Therefore, phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" appearing in various places throughout this specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0087] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative examples 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 methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, this disclosure includes modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A device for connecting to a medical connector, the device comprising: a cap comprising a unitary body, a closed end, an open end, an annular wall defining a chamber, the open end having a circumferential flange extending radially therefrom defining an engagement surface; the annular wall having an inner wall surface adapted to receive a male luer connector, wherein the male luer connector frictionally engages the inner wall surface when inserted into the chamber, the male luer connector resting on the circumferential flange when fully inserted into the chamber; the inner wall surface comprising internal threads adjacent the closed end, the internal threads extending partially along the length of the inner wall surface, the internal threads sized to engage a female luer connector; an absorbent material; a disinfectant or antimicrobial agent; a peelable seal; and a container comprising an annular container wall, the container housing the cap.

2. The apparatus of claim 1, wherein, the peelable seal is disposed on the open end face of the container.

3. The apparatus of claim 2, wherein, the peelable seal comprises an aluminum or multilayer polymeric film peel release backing top.

4. The apparatus of claim 2, wherein, the peelable seal is heat sealed or induction sealed to the open end face of the container to retain the cap within the container.

5. The apparatus of claim 1, wherein, the absorbent material is disposed in the chamber.

6. The apparatus of claim 5, wherein, the absorbent material is a foam or sponge.

7. The apparatus of claim 6, wherein, the foam is a polyurethane foam.

8. The apparatus of claim 5, wherein, the absorbent material is compressed toward the closed end of the chamber when connected to the female luer connector or the male luer connector.

9. The apparatus of claim 8, wherein, the compression of the absorbent material disinfects the female luer connector or the male luer connector.

10. The apparatus of claim 5, wherein, the absorbent material is radially compressed by the internal threads to retain the absorbent material in the chamber.

11. The apparatus of claim 5, wherein, the disinfectant or antimicrobial agent is disposed in the chamber.

12. The apparatus of claim 11, wherein, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethyl alcohol, 2-propanol, butyl alcohol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tertiary butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof.

13. The apparatus of claim 11, wherein, the disinfectant or antimicrobial agent is a fluid or a gel.

14. The apparatus of claim 1, wherein, the female luer connector comprises a needleless connector, a stopcock, or a hemodialysis connector.

15. The apparatus of claim 1, wherein, the male luer connector comprises an intravenous tubing end or a stopcock.

16. The apparatus of claim 1, wherein, the male luer connector frictionally engages the inner wall surface in a press fit connection when inserted into the chamber.

17. The apparatus of claim 1, wherein, the device further comprises a plurality of radial protrusions on an outer wall surface.

18. The apparatus of claim 17, wherein, the container has a plurality of complementary recesses to engage the plurality of radial protrusions.

19. The apparatus of claim 1, wherein, the cap is selectively coupled to the container via a key connection.

20. The apparatus of claim 18, wherein, the recesses of the container selectively couple the plurality of radial protrusions of the cap via a key connection.

21. The apparatus of claim 1, wherein, the cap is selectively coupled to the container via a sliding fit connection.

22. The apparatus of claim 18, wherein, The plurality of complementary recesses of the container selectively couple the plurality of radial protrusions of the cap via a snap-fit connection.

23. The apparatus of claim 18, wherein, The plurality of radial protrusions extend along an entire length of an outer wall surface of the cap and the plurality of complementary recesses extend along an entire length of an interior surface of the container.

24. The apparatus of claim 18, wherein, The plurality of radial protrusions extend along a portion of a length of an outer wall surface of the cap and the plurality of complementary recesses extend along a portion of a length of an interior surface of the container.

25. The apparatus of claim 1, wherein, The cap comprises an elastomeric material.

26. The apparatus of claim 25, wherein, The elastomeric material comprises a thermoplastic elastomer.

27. The device of claim 1, wherein, The annular wall of the cap is frustoconical.

28. The device of claim 1, wherein, An outer surface of the container comprises a plurality of gripping members.

29. The device of claim 1, wherein, The container comprises a polypropylene or polyethylene material.

30. The device of claim 1, wherein, The annular container wall is frustoconical.

31. A method of disinfecting a medical connector, the method comprising: The device of any of claims 1-30 is connected to a medical connector, wherein the connection comprises frictionally engaging the inner wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and a disinfectant or antimicrobial agent. The device of any of claims 1-30 is connected to a medical connector, wherein the connection comprises frictionally engaging the inner wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and a disinfectant or antimicrobial agent.

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