Universal disposable cap for male and female connectors

Abstract

An assembly comprising one or more of a male luer connector, a female luer connector, a needleless connector, a stopcock, or a hemodialysis connector; a device for connecting to a medical connector comprising a cap comprising: a unitary body; a first end comprising a first annular wall having a length defining a first chamber having a first open end; a second end comprising a second annular wall having a length defining a second chamber having a second open end, the first and second chambers each containing: an absorbent material; and a disinfectant or antimicrobial agent, the absorbent material in the first chamber comprising one or more concentric cylindrical slots corresponding to an end face of a stopcock or an accommodating cavity of a stopcock; the device connected to one or more of the male luer connector, the female luer connector, the needleless connector, the stopcock, and the hemodialysis connector.

Description

[0001] This application is a divisional application of Chinese patent application No. PCT / US2019 / 026487, Chinese application No. 201980033014.4, filed on April 9, 2019, entitled "Universal disposable cap for male and female connectors". Technical Field

[0002] This disclosure generally relates to an apparatus for disinfecting and sterilizing access ports having, for example, male Luer connectors and female Luer connectors, 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. VADs are generally classified into two types: peripheral catheters and central venous catheters. When connected to a VAD to deliver fluids or medications, bacteria and other microorganisms may 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 infection (CRBSI) and to ensure the proper use and maintenance of VADs, standard practices have been developed, which 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 IV catheters, needleless 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. INS Practice Standards recommend the use of needleless 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 needleless connector ultimately aims to help reduce bacteria that may survive on the surface and could lead to various catheter-related complications, including the aforementioned CRBSI events. Nurses typically perform this disinfection task by “wiping the interface” using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is generally very low. In addition to the lack of compliance with “wiping the interface,” interviews with clinicians have revealed inconsistencies in wiping time, drying time, and the number of times the needleless connector is wiped.

[0007] Numerous risks of contact or contamination exist within the series of procedures associated with the spread of microorganisms that may lead to CRBSI. Contamination can occur during drug mixing, cannulation, and insertion into the access interface. Because the procedure for connecting to a VAD is so common and straightforward, the risks associated with access to the patient's vascular system are often overlooked. Currently, the risks to hospitals and patients are primarily related to the level of care exerted by clinicians performing the connection, 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 this disclosure, the device generally includes a cap, a first chamber, a second chamber, a barrier wall disposed between the first chamber and the second chamber, a first seal, a second seal, a first annular wall including a plurality of internal threads, and a second annular wall including a plurality of external threads, an absorbent material, and a disinfectant or antimicrobial agent. The cap includes: an integral body; a first end including a first annular wall, the length of which defines a first chamber having a first open end; and a second end including a second annular wall, the length of which defines a second chamber and a second open end. The first chamber contains the absorbent material and the disinfectant or antimicrobial agent. The second chamber contains the absorbent material and the disinfectant or antimicrobial agent. The barrier wall is disposed between the first chamber and the second chamber. A first seal on the first open end prevents the disinfectant or antimicrobial agent from leaving the first chamber, and a second seal on the second open end prevents the disinfectant or antimicrobial agent from leaving the second chamber. In one or more embodiments, the annular wall of the cap is truncated conical.

[0010] The first annular wall includes an outer wall surface and an inner wall surface, the inner wall surface including a plurality of internal threads. In one or more embodiments, the internal threads extend partially along the length of the inner wall surface. In one or more embodiments, the internal threads extend completely along the length of the inner wall surface. In one or more embodiments, the plurality of internal threads are adapted to connect to a female Luer connector. In one or more embodiments, the male connector is an intravenous catheter end. The second annular wall includes an outer wall surface and an inner wall surface, the outer wall surface including a plurality of external threads. In one or more embodiments, the plurality of external threads are adapted to connect to a male Luer connector. In one or more embodiments, the external threads extend from the second open end for less than half the length of the second annular wall. In one or more embodiments, the female Luer connector is selected from the group consisting substantially of needleless connectors, stopcock valves, and hemodialysis connectors.

[0011] The cap 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 cap comprises polypropylene or polyethylene material.

[0012] 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 one or more embodiments, the absorbent material includes one or more grooves. In one or more embodiments, the one or more grooves are sized and adapted to receive a male Luer connector, a female Luer connector, or a hemodialysis connector. In one or more embodiments, the one or more grooves include one or more concentric cylindrical grooves. In one or more embodiments, the concentric cylindrical grooves correspond to the end face of a stopcock valve. In one or more embodiments, the concentric cylindrical grooves adapt to the cavity of a stopcock valve. In one or more embodiments, the absorbent material includes one or more openings. In one or more embodiments, the one or more openings are sized and adapted to receive a male Luer connector, a female Luer connector, or a hemodialysis connector. In one or more embodiments, the absorbent material is subjected to radial compression of the internal threads to retain the absorbent material within the cavity. In one or more embodiments, the absorbent material is retained within the cavity without being subjected to radial compression of the internal threads.

[0013] 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, otetanidine, 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.

[0014] In one or more embodiments, the absorbent material in the first chamber is compressed upon connection to the male Luer connector to sterilize the male Luer connector. In one or more embodiments, the absorbent material in the second chamber is compressed upon connection to the female Luer connector to sterilize the female Luer connector.

[0015] In one or more embodiments, the first seal and the second seal are peelable seals. In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel top. In one or more embodiments, the first seal is heat-sealed or inductively sealed to the first open end to retain the absorbent material within the first cavity. In one or more embodiments, the second seal is heat-sealed or inductively sealed to the second open end to retain the absorbent material within the second cavity.

[0016] In one or more embodiments, the outer wall surface of the first annular wall includes a plurality of gripping members. In one or more embodiments, the plurality of gripping members extend along the entire length of the outer wall surface of the cover. In yet another embodiment, the plurality of gripping members extend partially along the length of the outer wall surface of the cover. In one or more embodiments, the plurality of gripping members are elongated. In one or more embodiments, the plurality of gripping members are tapered.

[0017] A second aspect of this disclosure relates to a method for sterilizing a medical connector. In one or more embodiments, a method for sterilizing a medical connector includes removing a first seal, connecting a male Luer connector to a first open end to compress absorbent material in a first chamber, so that a disinfectant or antimicrobial agent contacts and sterilizes the male Luer connector. In an alternative embodiment, a method for sterilizing a medical connector includes removing a second seal, connecting a female Luer connector to a second open end to compress absorbent material in a second chamber, so that a disinfectant or antimicrobial agent contacts and sterilizes the female Luer connector. In yet another embodiment, a method for sterilizing a medical connector includes removing a first seal, connecting a male Luer connector to the first open end to compress absorbent material in a first chamber, so that a disinfectant or antimicrobial agent contacts and sterilizes the male Luer connector, removing a second seal, and connecting a female Luer connector to the second open end to compress absorbent material in a second chamber, so that a disinfectant or antimicrobial agent contacts and sterilizes the female Luer connector.

[0018] 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, needle-free connectors, stopcock valves, and hemodialysis connectors. Attached Figure Description

[0019] Figure 1 A perspective view showing an embodiment of the apparatus of this disclosure;

[0020] Figure 2 A perspective view showing an embodiment of the apparatus of this disclosure;

[0021] Figure 3 A perspective view showing an embodiment of the apparatus of this disclosure;

[0022] Figure 4 An exploded perspective view showing an embodiment of the apparatus of this disclosure;

[0023] Figure 5 An exploded perspective view showing an embodiment of the apparatus of this disclosure;

[0024] Figure 6 A top view of an embodiment of the apparatus of this disclosure is shown from the first end;

[0025] Figure 7 A top view of an embodiment of the apparatus of this disclosure is shown from the second end;

[0026] Figure 8 An exploded cross-sectional side view showing an embodiment of the device having a first seal and a second seal of the present disclosure;

[0027] Figure 9 A cross-sectional side view showing an embodiment of the apparatus of this disclosure;

[0028] Figure 10 Along the embodiments of the apparatus shown in this disclosure Figure 1 A partial sectional view obtained from line 10-10;

[0029] Figure 11 A perspective view showing a first seal or a second seal of an embodiment of the device of this disclosure;

[0030] Figure 12 A perspective view of an absorbent material according to an embodiment of a device suitable for connection with a female connector of the present disclosure;

[0031] Figure 13 A perspective view of an absorbent material according to an embodiment of a device suitable for connection with a female connector of the present disclosure;

[0032] Figure 14 A perspective view of an absorbent material according to an embodiment of a device suitable for connection with a male connector of the present disclosure;

[0033] Figure 15 A perspective view showing an alternative embodiment of the apparatus of this disclosure;

[0034] Figure 16 An exploded perspective view of an alternative embodiment of the apparatus of this disclosure is shown;

[0035] Figure 17 An exploded perspective view of an alternative embodiment of the apparatus of this disclosure is shown;

[0036] Figure 18 Alternative embodiments of the apparatus shown in this disclosure are illustrated along the lines of Figure 15 A partial sectional view obtained from line 18-18;

[0037] Figure 19A Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the male Luer connector;

[0038] Figure 19B Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the male Luer connector;

[0039] Figure 20A Show along Figure 15A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the female Luer connector;

[0040] Figure 20B Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the female Luer connector;

[0041] Figure 21 Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection of the device to the female Luer connector according to an alternative embodiment of the present disclosure;

[0042] Figure 22A Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the LAD;

[0043] Figure 22B Show along Figure 15 A partial sectional view obtained from line 18-18, which shows Figure 15 The connection between the device and the LAD;

[0044] Figure 23 shows a perspective view of a female Luer connector with a diaphragm according to the prior art;

[0045] Figure 24 shows a perspective view of a female Luer connector with a plug valve according to the prior art;

[0046] Figure 25 shows a perspective view of a male Luer connector according to the prior art;

[0047] Figure 26 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 and sterilization of medical connectors, the medical connectors comprising male and female Luer connectors. For sterilization purposes, the device of this disclosure can be used with access ports including needle-free connectors, male Luer connectors on IV lines / extensions, open female Luer connectors on stopcocks, and hemodialysis connectors. 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 use of “a,” “one,” and “the” includes both singular and plural forms.

[0052] When used in this document, the term “catheter-associated bloodstream infection” or “CRBSI” refers to any infection resulting from the presence of a catheter or IV 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, IV tubing, 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 external threaded edges for added strength. The male end of a Luer connector is typically associated with a flushing syringe and can interlock 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 profiled central channel for fluid communication from the chamber of the syringe barrel to the interface of the VAD. The Luer connector also has a distal end channel for releasably attaching the Luer connector to the interface of the VAD, and a proximal end channel for releasably attaching the Luer connector to the barrel of the syringe.

[0054] refer to Figure 1-10 A device 100 for connection to a medical connector according to an exemplary embodiment of the present disclosure typically includes a cover 102, a first chamber 114, a second chamber 126, a barrier wall 140 disposed between the first chamber 114 and the second chamber 126, a first seal 150, a second seal 160, a first annular wall 108 including a plurality of internal threads 170, and a second annular wall 120 including a plurality of external threads 180, an absorbent material 130, and a disinfectant or antimicrobial agent. The cover 102 includes: an integral body 104; a first end 106 including the first annular wall 108, the first annular wall having a length L. faDefines a first chamber 114 having a first open end 116; and a second end 118 including a second annular wall 120 having a length L. sa A second chamber 126 is defined, having a second open end 128. A first chamber 114 contains absorbent material 130 and a disinfectant or antimicrobial agent. The second chamber 126 contains absorbent material 130 and a disinfectant or antimicrobial agent. A barrier wall 140 is disposed between the first chamber 114 and the second chamber 126. The barrier wall 140 separates the first chamber 114 and the second chamber 126 to maintain independence between male and female Luer connector sterilization. Furthermore, even if the first seal 150 or the second seal 160 on the non-sterilized side is unintentionally removed or damaged, the barrier wall 140 can still maintain sterility on the sterilized side by preventing fluid leakage from the connector (e.g., an IV tube or a stopcock valve) through the cap 102.

[0055] A first seal 150 on the first open end 116 prevents disinfectant or antimicrobial agent from leaving the first chamber 114, and a second seal 160 on the second open end 128 prevents disinfectant or antimicrobial agent from leaving the second chamber 126. In one or more embodiments, the annular wall of the cover 102 extending from the first annular wall 108 to the second annular wall 120 is truncated conical.

[0056] The first annular wall 108 includes an outer wall surface 110 and an inner wall surface 112, the inner wall surface 112 including a plurality of internal threads 170. In one or more embodiments, the internal threads 170 extend partially along the length of the inner wall surface 112. In one or more embodiments, the internal threads 170 extend completely along the length of the inner wall surface 112. In one or more embodiments, the plurality of internal threads 170 are adapted to connect to a vaginal Luer connector 300. In one or more embodiments, the vaginal Luer connector 300 may include a needleless connector, a stopcock valve, and / 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, MicroClaveclear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc. The second annular wall 120 includes an outer wall surface 122 and an inner wall surface 124, the outer wall surface 122 including a plurality of external threads 180. In one or more embodiments, the plurality of external threads 180 are adapted to connect to a male Luer connector 400. In one or more embodiments, the external threads 180 extend from a second open end 128 along less than half the length of the second annular wall 120. In one or more embodiments, the male connector is an intravenous catheter end.

[0057] In one or more embodiments, the female connector 200 may include a needleless connector, a catheter Luer connector, a stopcock valve, and / or a hemodialysis connector 500. In one or more embodiments, the female connector comprises a female Luer connector.

[0058] In one or more embodiments, the male connector 400 may include an intravenous catheter end, a stopcock valve, or a male Luer lock connector. In one or more embodiments, the male connector comprises a male Luer connector.

[0059] In one or more embodiments, the internal thread 170 may be provided adjacent to the bottom of the first chamber 114 of the cover and extend partially along the length of the inner wall surface 112 of the cover.

[0060] In one or more embodiments, the male Luer connector engages multiple external threads 180 when inserted into the chamber.

[0061] In one or more embodiments, the annular wall of the cover 102 extending from the first annular wall 108 to the second annular wall 120 is a truncated cone shape.

[0062] The cover 102 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 cover 102 comprises a polypropylene or polyethylene material. In one or more embodiments, the outer wall surface 110 of the first annular wall 108 includes a plurality of gripping members 190.

[0063] exist Figure 12-14 An exemplary embodiment of absorbent material 130 is shown. In one or more embodiments, absorbent material 130 is a nonwoven material, foam, or sponge. In a particular embodiment, the foam is polyurethane foam. In one or more embodiments, absorbent material 130 includes one or more grooves 132. In one or more embodiments, as... Figure 12-14 As shown, one or more slots 132 are sized and adapted to receive a male Luer connector, a female Luer connector, or a hemodialysis connector. In one or more embodiments, as Figure 13 As shown, one or more grooves 132 are provided on the sidewall of the absorbent material and are sized and adapted to receive corresponding threads provided on the inner ring of the first chamber and / or the second chamber. In one or more embodiments, as Figure 12 and 13 As shown, one or more grooves 132 include one or more concentric cylindrical grooves 134, which are cut into an absorbent material containing a disinfectant or antimicrobial agent. In one or more embodiments, for example, as Figure 12 and 13 As shown, the concentric cylindrical groove 134 corresponds to the end face of the plug valve.

[0064] In one or more embodiments, concentric cylindrical grooves are adapted to the cavity of the stopcock valve to enhance cleaning of the stopcock valve cavity. In a particular embodiment, when the stopcock valve is screwed onto the chamber of device 100, the concentric cylindrical grooves of absorbent material are inserted into the cavity of the stopcock valve to disinfect the inside of the stopcock valve. In one or more embodiments, absorbent material 130 includes one or more openings 136. In one or more embodiments, the one or more openings 136 are sized and adapted to receive a male Luer connector 400, a female Luer connector 300, or a hemodialysis connector 500. In a particular embodiment, absorbent material 130 is in the form of a foam plug. In one or more embodiments, absorbent material 130 is subjected to radial compression by internal threads 170 to retain absorbent material within the chamber. In one or more embodiments, absorbent material is retained within the chamber without being subjected to radial compression by internal threads.

[0065] When used on a Luer connector, device 100 can achieve disinfection by integrating a disinfectant or antimicrobial agent into the first chamber 114 and / or the second chamber 126 of the cap. The disinfectant or antimicrobial agent can be directly contained in the first chamber 114 and / or the second chamber 126, or it can be absorbed into the absorbent material 130 filling the first chamber 114 and / or the second chamber 126. Device 100 is designed to be compatible with a variety of disinfectants. 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, oxytetracycline, antibiotics, and mixtures thereof. In one or more embodiments, the disinfectant or antimicrobial agent may contain a variant of alcohol or chlorhexidine. 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.

[0066] In one or more embodiments, the absorbent material 130 in the first chamber 114 is compressed upon connection to the male Luer connector to sterilize the male Luer connector. In one or more embodiments, the absorbent material 130 in the second chamber 126 is compressed upon connection to the female Luer connector 300 to sterilize the female Luer connector.

[0067] like Figure 3-5 As shown in Figures 8 and 9, a first seal 150 is disposed on the first open end 116 to prevent the disinfectant or antimicrobial agent from leaving the first chamber 114, and a second seal 160 is disposed on the second open end 128 to prevent the disinfectant or antimicrobial agent from leaving the second chamber 126. In one or more embodiments, the first seal 150 is heat-sealed or inductively sealed to the first open end 116 to retain the absorbent material 130 within the first chamber 114. In one or more embodiments, the second seal 160 is heat-sealed or inductively sealed to the second open end 128 to retain the absorbent material 130 within the second chamber 126.

[0068] exist Figure 11Exemplary embodiments of a first seal 150 and / or a second seal 160 are illustrated. In one or more embodiments, the first seal 150 and the second seal 160 are peelable seals. In one or more embodiments, the first seal 150 and the second seal 160 include a peelable top of aluminum or a multilayer polymer film. In one or more embodiments, the first seal 150 and the second seal 160 include a moisture-proof layer.

[0069] In one or more embodiments, the outer wall surface 110 of the first annular wall 108 of the cover 102 includes a plurality of gripping members 190. In one or more embodiments, the plurality of gripping members 190 extend along the entire length of the outer wall surface 110 of the cover. In yet another embodiment, the plurality of gripping members 190 extend partially along the length of the outer wall surface 110 of the cover. In one or more embodiments, the plurality of gripping members 190 are elongated. In one or more embodiments, the plurality of gripping members 190 are tapered.

[0070] In alternative embodiments of this disclosure, reference is made to Figure 15-17 A device 200 for connection to a medical connector according to exemplary embodiments of the present disclosure typically includes a cover 202, a first chamber 214, a second chamber 226, a first seal 250, a second seal 260, a first annular wall 208 including a plurality of internal threads 270, a second annular wall 220 including a plurality of external threads 280, a first absorbent material 230, a second absorbent material 232, and a disinfectant or antimicrobial agent. The cover 202 includes: an integral body 204; a first end 206 including the first annular wall 208, the first annular wall having a length L. fb Defines a first chamber 214 having a first open end 216; and a second end 218 including a second annular wall 220 having a length L. sb A second chamber 226 is defined, having a second open end 228. A first chamber 214 contains a first absorbent material 230 and a disinfectant or antimicrobial agent. The second chamber 226 contains a second absorbent material 232 and a disinfectant or antimicrobial agent. The second absorbent material 232 is held in place by frictional engagement by extending into the first absorbent material 230. When connected to a medical connector, such as a female Luer connector, male Luer connector, or a needleless Luer connector access device (LAD), the absorbent materials (one or more) 230 and 232 are held in place by frictional engagement, but the absorbent materials 230 and 232 can slide to accommodate the medical connector.

[0071] The cover 202 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 cover 202 comprises a polypropylene or polyethylene material. In one or more embodiments, the outer wall surface 210 of the first annular wall 208 includes a plurality of gripping members 290.

[0072] refer to Figure 19A and 19B To cover the male Luer connector 600 and / or disinfect it, the second seal 260 is removed and the cap 202 is attached via the second open end 228. The second absorbent material 232 is compressible, and screwing the cap 202 onto the male Luer connector ensures that the surface of the male Luer connector will come into contact with the absorbent material 232 and the disinfectant or antimicrobial agent. The second open end 228 forms a fluid seal with the male Luer connector, just like the unopened second seal 250 of the cap 202. The device 200 can remain on the male Luer connector as needed to protect it and keep it clean until the next use of the male Luer connector.

[0073] refer to Figure 20A and 20B To cover and / or disinfect the female Luer connector 602, as on a stopcock valve, the first seal 250 is removed and the cap 202 is attached to the female Luer connector via the first open end 216. A first absorbent material 230 protrudes into the female Luer connector 602, thereby allowing disinfectant or antimicrobial agents to contact and disinfect the female Luer connector 602. In one or more embodiments, the female Luer connector 602 is not sealed by the device 200 because the fluid path has been interrupted by the stopcock valve on the female Luer connector 602.

[0074] refer to Figure 21 In an alternative embodiment, an elastomeric seal 240 may be placed on the inside of the cover 202 near the first absorbent material 230 to seal the female Luer connector 602.

[0075] refer to Figure 22A and 22BTo cover and / or sterilize a needleless Luer connector access device (LAD) 604, such as a Q-Syte or MaxPlus connector, the first seal 250 is removed, and the cover 202 is attached to the LAD 604, similar to attaching a cover 202 to a female Luer connector. The first absorbent material 230 will not penetrate the LAD 604 as it does through the female Luer connector; instead, the first absorbent material 230 will be pushed into the device 200 towards the second seal 260. This will leave space for the LAD 604 while allowing disinfectants or antimicrobial agents to contact the top surface of the LAD 604 for sterilization. The LAD is self-sealing, so the device 200 does not provide a fluid seal.

[0076] In one or more embodiments, the porous and / or absorbent materials (one or more) 230 and 232 may be rigid, may be open-cell foam, or may be polymeric sintered materials that can be molded into defined shapes, similar to products manufactured by Porex Corporation of Fairburn, Georgia.

[0077] Currently available sterilization caps can only sterilize one type of connector (e.g., female or male Luer connectors, etc.). Therefore, to avoid the need to use different types of sterilization caps to clean different types of connectors, the double-ended cap of this disclosure engages with both male and female Luer connectors, allowing users to clean different types of connectors with a single device. When the cap is installed on the female Luer connector, the female Luer connector is inserted into the first chamber to contact the absorbent material and the disinfectant or antimicrobial agent. When the cap is installed on the male Luer connector, the male Luer connector is inserted into the second chamber to contact the absorbent material and the disinfectant or antimicrobial agent. Therefore, the device 100 of this disclosure can be installed on both male and female Luer connectors, thus meeting current needs in the art.

[0078] Referring to Figures 23-26, in one or more embodiments, the cap of the device of this disclosure can form a fluid-impermeable seal with the female Luer connector 300, the male Luer connector 400, or the hemodialysis connector 500. Referring to Figures 23-26, 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. In certain embodiments, the cap conforms to ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) for forming a seal with the male Luer connector.

[0079] In one or more embodiments, the cover of the device disclosed herein has threads having a specific size and pitch to engage the threaded segment of a female connector, such as a female Luer connector. Such connectors are commonly and frequently used in medical applications as protective connectors for catheters and other fluid-impermeable devices. In some embodiments, the cover 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 cover and form a releasable connection with the cover's threads.

[0080] 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, as the connector will remain uncontaminated when attached to the cap. The cap is used instead of the standard wiping protocol for cleaning the connector.

[0081] In one or more embodiments, the thread size and pitch of the cap are configured to engage the threads of the male Luer lock connector. For example, the connector may include an end of the IV tubing assembly that is separate from the needleless injection site of the IV catheter.

[0082] A second aspect of this disclosure relates to a method for sterilizing a medical connector. In one or more embodiments, a method for sterilizing a medical connector includes: removing a first seal 150 and connecting a male Luer connector 400 to a first open end 116 to compress absorbent material 130 in a first chamber 114, thereby allowing a disinfectant or antimicrobial agent to contact and sterilize the male Luer connector 400. In an alternative embodiment, a method for sterilizing a medical connector includes removing a second seal 160 and connecting a female Luer connector 300 to a second open end 128 to compress absorbent material 130 in a second chamber 126, thereby allowing a disinfectant or antimicrobial agent to contact and sterilize the female Luer connector 300. In yet another embodiment, a method for sterilizing a medical connector includes removing a first seal 150, connecting a female Luer connector to a first open end 116 to compress absorbent material 130 in a first chamber 114 to allow a disinfectant or antimicrobial agent to contact and sterilize the female Luer connector, removing a second seal 160, and connecting a male Luer connector to a second open end 128 to compress absorbent material 130 in a second chamber 126 to allow a disinfectant or antimicrobial agent to contact and sterilize the male Luer connector.

[0083] A third aspect of this disclosure relates to a component. The component includes a means 100, according to one or more embodiments, connected to a medical connector. In one or more embodiments, the medical connector is selected from male Luer connectors, female Luer connectors, needle-free connectors, stopcock valves, and hemodialysis connectors.

[0084] 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.

[0085] 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 component, the component comprising: One or more of the following: male Luer connector, female Luer connector, needleless connector, stopcock valve, or hemodialysis connector; A device for connecting to a medical connector, the device comprising: A cover, comprising: an integral body having a first open end and a second open end; a first annular wall having a length defining a first chamber extending from the first open end; a second annular wall having a length defining a second chamber extending from the second open end; the first chamber containing a first absorbent material and a disinfectant or antimicrobial agent; the second chamber containing a second absorbent material and a disinfectant or antimicrobial agent; the absorbent material in the first chamber comprising one or more concentric cylindrical grooves corresponding to an end face of a stopcock valve or adapted to a cavity of a stopcock valve; A first seal at the first open end, the first seal preventing disinfectant or antimicrobial agent from leaving the first chamber; and A second seal on the second open end, the second seal preventing disinfectant or antimicrobial agent from leaving the second chamber; An elastomeric seal is disposed in the first chamber, the elastomeric seal forming a ring extending from the inner wall surface of the first annular wall and surrounding the first absorbent material. The first annular wall has an outer wall surface and an inner wall surface. The inner wall surface of the first annular wall includes corresponding threads, which include a plurality of internal threads adapted for connection to a female Luer connector. The elastomeric seal is configured to seal the female Luer connector when it is connected to the plurality of internal threads. The second annular wall has an outer wall surface and an inner wall surface, and the outer wall surface of the second annular wall includes a plurality of external threads adapted for connection to a male Luer connector; The device is connected to one or more of the male Luer connector, the female Luer connector, the needleless connector, the stopcock valve, and the hemodialysis connector.

2. The assembly of claim 1, wherein, The external thread of the device extends from the second open end along less than half the length of the second annular wall.

3. The assembly of claim 1, wherein, The internal thread extends partially along the length of the inner wall surface of the first annular wall.

4. The assembly of claim 1, wherein, The internal thread extends completely along the length of the inner wall surface of the first annular wall.

5. The assembly of claim 1, wherein, The absorbent material includes one or more seams.

6. The assembly of claim 5, wherein, The one or more opening sizes are configured and adapted to receive male Luer connectors, female Luer connectors, or hemodialysis connectors.

7. A method for sterilizing the component according to any one of claims 1 to 6, the method comprising: Remove the first seal; and The male Luer connector is connected to the first open end to compress the absorbent material in the first chamber, so that a disinfectant or antimicrobial agent comes into contact with and disinfects the male Luer connector.

8. A method for sterilizing the component according to any one of claims 1 to 6, the method comprising: Remove the second seal; and Connect the nut connector to the second open end to compress the absorbent material in the second chamber so that a disinfectant or antimicrobial agent comes into contact with and disinfects the nut connector.

9. A method for sterilizing the component according to any one of claims 1 to 6, the method comprising: Remove the first seal; The male Luer connector is connected to the first open end to compress the absorbent material in the first chamber so that a disinfectant or antimicrobial agent comes into contact with and disinfects the male Luer connector. Remove the second seal; and Connect the nut connector to the second open end to compress the absorbent material in the second chamber so that a disinfectant or antimicrobial agent comes into contact with and disinfects the nut connector.

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