Universal disposable caps for male and female connectors

Abstract

A device for connecting to a medical connector includes a cap, a resilient sealing ring, and a peelable seal. The cap is configured to define a chamber for containing an absorbent material and a disinfectant or antimicrobial agent. The cap includes 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 escaping the chamber.

Description

[0001] This application is a divisional application of the Chinese patent application with international application number PCT / US2019 / 026538, Chinese application number 201980033318.0, application date April 9, 2019, and name “Universal disposable cover for male and female connectors”. Technical Field

[0002] The present disclosure generally relates to a device for disinfecting and sterilizing access ports, such as male and female Luer adapters, and more particularly to a disinfecting and sterilizing device that can accommodate multiple types of connectors. Background Art

[0003] Vascular access devices (VADs) are commonly used therapeutic devices, including intravenous (IV) catheters. There are two general categories of VADs: peripheral catheters and central venous catheters. Bacteria and other microorganisms may enter the patient's vascular system through the access port and port / valve when they are connected to the VAD to deliver fluids or medications. Every access port (or port / valve or connection) carries some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

[0004] To reduce instances of CRBSI and ensure proper use and maintenance of VADs, standards of practice have been developed that include disinfection and cleaning procedures.

[0005] Sterile caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and early indications are that they will also be included in the 2016 Infusion Nurses Standards (INS) guidelines.

[0006] In developed markets, when using an intravenous catheter, a needleless connector is typically used to close the system. The connector is then used to administer medications or other necessary fluids to the patient through the catheter. The INS operating standards recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol mixture before each use." Disinfection of needleless connectors is ultimately intended to help reduce bacteria that may be present on their surfaces and could lead to various catheter-related complications, including CRBSI. Nurses typically accomplish this disinfection task by performing a "port swabbing" using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is often low. In addition to the lack of compliance with "port swabbing," clinician interviews noted variations in swabbing time, drying time, and the number of times needleless connectors are swabbed.

[0007] Throughout the entire process, there are numerous risks of exposure or contamination associated with the transmission of microorganisms that could cause CRBSI. Contamination can occur during medication mixing, cannula connection, and insertion of the access port. Because the process of connecting to a VAD is so common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is a major variable dependent on the level of effort put into performing the connection by the clinician, and this level of effort is largely uncontrollable.

[0008] Currently, caps for male and female needleless connectors, intravenous (IV) and hemodialysis lines use different designs, limiting the cap's design to the type of connector it can be connected to. Consequently, existing disinfection caps are designed to fit only one type of connector and are specific to a particular size and / or shape. Therefore, there is a need for a disinfection device that can accommodate multiple connector types to simplify the disinfection process. There is also a need for a disinfection device that can perform disinfection continuously for several days. Summary of the Invention

[0009] One aspect of the present disclosure relates to a device for connecting to a medical connector. According to exemplary embodiments of the present disclosure, the device generally includes a cap, a resilient sealing ring, an absorbent material, a disinfectant or antimicrobial agent, and a peelable seal. The cap includes a unitary body, a closed end, and an annular wall 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 defines an end face and has a circumferential wall extending radially inward from the annular wall, and the open end defines an engagement surface.

[0010] The annular wall of the cover has an outer wall surface and an inner wall surface. The inner wall surface defines an opening adjacent to the open end.

[0011] The elastomeric sealing ring has an expandable opening therethrough that is sized and adapted to accommodate a male Luer connector, a female Luer connector, and a hemodialysis connector. The expandable opening can be sized to frictionally engage a male Luer connector or a female Luer connector of a compatible diameter.

[0012] In one or more embodiments, the diameter of the expandable opening is expandable from an initial diameter in the range of about 7-9 mm to an expanded diameter in the range of about 9-12 mm. In one or more embodiments, the elastomeric sealing ring contacts the circumferential abutment. In one or more embodiments, the male luer connector frictionally engages the expandable opening via a press-fit connection when inserted through the expandable opening of the elastomeric sealing ring into the chamber.

[0013] In one or more embodiments, the opening adjacent the open end of the inner wall surface is sized and adapted to receive the elastomeric sealing ring in a press-fit connection.

[0014] The inner wall surface includes an internal thread adjacent to the closed end. The internal thread is sized and adapted to connect to a female Luer connector. In one or more embodiments, the internal thread adjacent to the closed end of the cap extends partially along the length of the inner wall surface of the cap.

[0015] The absorbent material and the disinfectant or antimicrobial agent come into contact with the male Luer connector, the female Luer connector, and the hemodialysis connector after the connectors are inserted through the expandable opening of the elastomeric sealing ring.

[0016] A peelable seal is provided on an end surface of the cover to prevent the disinfectant or antimicrobial agent from leaving the chamber.

[0017] In one or more embodiments, the female Luer connector is selected from the group consisting of a needle-free connector, a stopcock, and a hemodialysis connector.

[0018] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0019] In one or more embodiments, the male luer connector rests on a circumferential ledge when fully inserted into the chamber.

[0020] In one or more embodiments, the male luer connector frictionally engages the inner wall surface via a press-fit connection when inserted into the chamber.

[0021] In one or more embodiments, the opening adjacent the open end of the inner wall surface of the cap is sized and adapted to receive a male luer connector in a press-fit connection.

[0022] The elastic sealing ring comprises an elastomeric material.

[0023] In one or more embodiments, the elastomeric material of the elastic sealing ring comprises a thermoplastic elastomer.

[0024] In one or more embodiments, the chamber includes a first portion adjacent the closed end having a first portion diameter and a second portion adjacent the open end having a second portion diameter, the first portion and the second portion being in fluid communication with each other, and the first portion diameter being smaller than the second portion diameter. In one or more embodiments, the annular wall of the cover is frustoconical.

[0025] The cover is made of any of a variety of types of plastics, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic used in medical devices. In one or more embodiments, the cover comprises polypropylene or polyethylene material. In one or more embodiments, the outer cover surface comprises a plurality of gripping members.

[0026] In one or more embodiments, the absorbent material is radially compressed 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 radially compressed by the internal threads. In one or more embodiments, the absorbent material is a nonwoven material, foam, or sponge. In a specific embodiment, the foam is a polyurethane foam.

[0027] In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctyl hydroquinone, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0028] When connected to the female or male luer connector, compression of the absorbent material toward the closed end of the chamber allows the connector to contact the disinfectant or antimicrobial agent to sterilize the female or male luer connector.

[0029] In one or more embodiments, the peelable seal comprises aluminum or a multi-layer polymer film peelable back top. In certain embodiments, the peelable seal is heat sealed or induction sealed to the open end of the lid.

[0030] Alternative embodiments of the present disclosure are directed to a device for connecting to a medical connector according to exemplary embodiments of the present disclosure, the device generally comprising a cap, an elastomeric sealing ring having one or more undercuts and an expandable opening, an absorbent material, a disinfectant or antimicrobial agent, and a peelable seal.

[0031] A second aspect of the present disclosure relates to a method for disinfecting a medical connector. The method includes connecting a device of one or more embodiments to the medical connector, wherein the connection includes engaging an inner wall surface when the medical connector is inserted into a cavity, such that the medical connector contacts an absorbent material and a disinfectant or antimicrobial agent.

[0032] A third aspect of the present disclosure relates to an assembly comprising a device according to one or more embodiments coupled to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Figure 1shows a side view of an apparatus according to an embodiment of the present disclosure;

[0034] Figure 2 shows a top perspective view of an apparatus according to an embodiment of the present disclosure;

[0035] Figure 3 shows a partial cross-sectional view of components of an apparatus according to an embodiment of the present disclosure;

[0036] Figure 4 shows a partial cross-sectional view of components of an apparatus according to an embodiment of the present disclosure;

[0037] Figure 5 shows a top view of components of an apparatus according to an embodiment of the present disclosure;

[0038] Figure 6 shows a side view of an apparatus according to an alternative embodiment of the present disclosure; and

[0039] Figure 7 shows a partial cross-sectional view of components of an alternative apparatus according to an alternative embodiment of the present disclosure;

[0040] FIG8 shows a perspective view of a female Luer connector with a septum according to the prior art;

[0041] FIG9 shows a perspective view of a female Luer connector with a stopcock according to the prior art;

[0042] FIG10 shows a perspective view of a male Luer connector according to the prior art;

[0043] FIG. 11 shows a perspective view of a hemodialysis connector according to the prior art. DETAILED DESCRIPTION

[0044] 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, and the present disclosure is capable of other embodiments and can be practiced or carried out in various ways.

[0045] Embodiments of the present disclosure relate to a universal, disposable device for connecting and sterilizing medical connectors, including male and female Luer connectors, comprising a cap, an elastomeric sealing ring, an absorbent material, a disinfectant or antimicrobial agent, and a peelable seal. The device provides a mechanical barrier for the connector and contains an antimicrobial agent for sterilization. The disclosed device allows practitioners to simplify the sterilization process.

[0046] With respect to terms used in this disclosure, the following definitions are provided.

[0047] As used herein, the use of “a,” “an,” and “the” includes both the singular and the plural.

[0048] 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.

[0049] As used herein, the term "Luer connector" refers to a connecting collar that is a standard way of attaching syringes, catheters, ported needles, IV lines, etc. to each other. A Luer connector consists of slightly tapered male and female interlocking tubes that are better held together even with a simple press / twist fit. Luer connectors can optionally include additional externally threaded rims 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 the female end located on a vascular access device (VAD). The Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a contoured central passageway for fluid communication from the chamber of the syringe's barrel to the port of the VAD. The Luer connector also has a distal channel that releasably connects the Luer connector to the port of the VAD, and a proximal channel that releasably connects the Luer connector to the syringe's barrel.

[0050] exist Figure 1-4 1 shows an assembly apparatus 100 according to one or more embodiments. Figure 5 A cover component of a device according to an embodiment of the present disclosure is shown. Figure 6 and Figure 7 FIG8 shows a device and its components according to an alternative embodiment of the present disclosure. FIG8 to FIG11 show various medical connectors according to the prior art. Figure 1-5 The device 100 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally includes a cap 102, an elastic sealing ring 126, an absorbent material 114, a disinfectant or antimicrobial agent, and a peelable seal 150. The cap 102 includes an integral body 104, a closed end 106, an annular wall 108, and a length L of the annular wall. C The annular wall 108 extends from the closed end 106 to the open end 110 and defines a chamber 112 containing an absorbent material 114 and a disinfectant or antimicrobial agent. The open end 110 defines an end face 116 and includes a circumferential wall 118 extending radially inwardly from the annular wall 108. The open end 110 also defines an engagement surface 120.

[0051] The annular wall 108 of the cover 102 includes an outer wall surface 122 and an inner wall surface 124. The inner wall surface 124 defines an opening 132 adjacent the open end 110.

[0052] The elastic sealing ring 126 includes an expandable opening 128 therethrough that is sized and adapted to accommodate a male Luer connector, a female Luer connector, and a hemodialysis connector. The expandable opening 128 can be sized to frictionally engage with a male Luer connector or a female Luer connector having a compatible diameter. In one or more embodiments, the diameter of the expandable opening 128 can be expanded from an initial diameter in the range of approximately 7-9 mm to an expanded diameter in the range of approximately 9-12 mm. In one or more embodiments, the elastic sealing ring 126 contacts the circumferential wall 118. In one or more embodiments, the male Luer connector is frictionally engaged with the expandable opening 128 by a press-fit connection when inserted into the chamber 112 through the expandable opening 128 of the elastic sealing ring 126. In one or more embodiments, the elastic sealing ring 126 contacts the circumferential wall 118.

[0053] In one or more embodiments, the opening 132 of the inner wall surface 124 adjacent the open end 110 is sized and adapted to receive the elastomeric sealing ring 126 in a press-fit connection.

[0054] The inner wall surface 124 includes internal threads 130 adjacent to the closed end 106. The internal threads 130 are sized and adapted to engage a female Luer connector. In one or more embodiments, the internal threads 130 adjacent to the closed end 106 of the cap 102 extend partially along the length of the inner wall surface 124 of the cap 102.

[0055] After the connectors are inserted through the expandable opening 128 of the elastomeric sealing ring 126, the absorbent material 114 and the disinfectant or antimicrobial agent come into contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0056] A peelable seal 150 is provided on the end surface 116 of the lid 102 to prevent the disinfectant or antimicrobial agent from exiting the chamber 112 .

[0057] The inner wall surface 124 includes internal threads 130 adjacent to the closed end 106. The internal threads 130 are sized and adapted to engage a female Luer connector. After the connectors are inserted into the open end 110 of the cap 102, the absorbent material 114 and the disinfectant or antimicrobial agent come into contact with the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0058] In one or more embodiments, the outer wall surface 122 of the cover 102 includes a plurality of gripping members 134 .

[0059] The cover 102 includes an annular cover wall 108 having a cover wall length L extending from the closed end 106 of the cover to the open end 110 of the cover. C The cover 102 includes an inner wall surface 124 and an outer wall surface 122 .

[0060] A peelable seal 150 is provided on the open end 110 of the lid to prevent the disinfectant or antimicrobial agent from exiting the chamber 112 .

[0061] In one or more embodiments, the female 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 the group consisting of a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, and the like.

[0062] In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male lock Luer connector.

[0063] In one or more embodiments, the male luer connector rests on the circumferential abutment 118 when fully inserted into the chamber 112 .

[0064] In one or more embodiments, the internal threads 130 adjacent the closed end 106 of the cap 102 extend partially along the length of the inner wall surface 124 of the cap 102 .

[0065] In one or more embodiments, the male luer connector frictionally engages the inner wall surface 124 via a press-fit connection when inserted into the chamber 112 .

[0066] In one or more embodiments, the opening 132 adjacent the open end 110 of the inner wall surface 124 of the cap 102 is sized and adapted to receive a male luer connector in a press-fit connection.

[0067] The resilient sealing ring 126 comprises an elastomeric material.

[0068] In one or more embodiments, the elastomeric material of the elastomeric sealing ring 126 includes a thermoplastic elastomer.

[0069] In one or more embodiments, the chamber 112 includes a first portion 136 adjacent the closed end 106 having a first portion diameter D1 and a second portion 138 adjacent the open end 110 having a second portion diameter D2, the first portion 136 and the second portion 138 being in fluid communication with each other, and the first portion diameter D1 being smaller than the second portion diameter D2. In one or more embodiments, the annular wall 108 of the cover 102 is frustoconical.

[0070] The cover 102 is made of any of a variety of plastic types, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic used in medical devices. In one or more embodiments, the cover 102 comprises polypropylene or polyethylene material. In one or more embodiments, the outer wall surface 122 includes a plurality of gripping members 134.

[0071] In one or more embodiments, the absorbent material 114 is radially compressed by the internal threads 130 to retain the absorbent material 114 within the chamber 112. In one or more embodiments, the absorbent material is retained within the chamber without being radially compressed by the internal threads. In one or more embodiments, the absorbent material 114 is a nonwoven material, foam, or sponge. In one particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the absorbent material 114 is in the form of a foam plug.

[0072] When the device 100 is used on a Luer connector, disinfection can be achieved by integrating a disinfectant or antimicrobial agent into the chamber 112 of the cap 102. The disinfectant or antimicrobial agent can be contained directly in the chamber 112, or the disinfectant or antimicrobial agent can be absorbed into the sponge or foam material that fills the chamber 112 of the cap 102. The device 100 is designed to be compatible when interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctyl hydroquinone, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0073] When connected to a female or male luer connector, compression of the absorbent material 114 toward the closed end 106 of the chamber 112 allows the connector to contact a disinfectant or antimicrobial agent to sterilize the female or male luer connector.

[0074] In one or more embodiments, a peelable seal 150 may be placed on the end face 116 to prevent the disinfectant or antimicrobial agent from leaving the chamber 112 .

[0075] In one or more embodiments, the peelable seal 150 comprises an aluminum or multi-layer polymer film peelable back top. In certain embodiments, the peelable seal 150 is heat sealed or induction sealed to the open end of the lid. In one or more embodiments, the peelable seal 150 comprises a moisture barrier.

[0076] In one or more embodiments, the outer wall surface 122 of the cover includes a plurality of gripping members 134 .

[0077] Sterilization caps currently on the market can only sterilize one of three types of Luer connectors: the female Luer connector of a needleless connector at an intravenous injection site, the female Luer connector of a stopcock, and the male Luer connector. Therefore, to avoid having to use different types of sterilization caps to clean different types of connectors, cap 102 engages with both the male and female Luer connectors, allowing the user to use a single device to clean different types of connectors. When cap 102 is installed on the female Luer connector, the female Luer connector is inserted into chamber 112 and screwed onto the internal threads 130 of cap 102. When cap 102 is installed on the male Luer connector, the male Luer connector frictionally engages the inner wall surface 124 when inserted into chamber 112. Therefore, the device 100 of the present disclosure can be installed on both male and female Luer connectors, thereby meeting the current needs in the art.

[0078] like Figure 6 and Figure 7 As shown, another aspect of the present disclosure relates to an assembly device 200 having a resilient sealing ring 226 that includes one or more cutouts and / or tapered surfaces 227 to provide improved adaptability to various types of connectors. Figure 6 and Figure 7 The device 200 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally includes a cap 202, an elastic sealing ring 226 including one or more cutouts and / or tapered surfaces 227, an absorbent material 214, a disinfectant or antimicrobial agent, and a peelable seal 250. The cap 202 includes a unitary body 204, a closed end 206, an annular wall 208, and a length L of the annular wall. C The annular wall 208 extends from the closed end to the open end 210 and defines a chamber 212 containing an absorbent material 214 and a disinfectant or antimicrobial agent. The open end 210 defines an end face 216 and includes a circumferential wall 218 extending radially inwardly from the annular wall 208. The open end 210 also defines an engagement surface 220.

[0079] The annular wall 208 of the cover 202 includes an outer wall surface 222 and an inner wall surface 224. The inner wall surface 224 defines an opening 232 adjacent the open end 210.

[0080] The elastomeric sealing ring 226 includes one or more cutouts and / or tapered surfaces 227 that provide improved adaptability to various types of connectors, and an expandable opening 228 therethrough that is sized to accommodate a male Luer connector, a female Luer connector, and a hemodialysis connector. The expandable opening 228 can be sized to frictionally engage with a male Luer connector or a female Luer connector having a compatible diameter. In one or more embodiments, the diameter of the expandable opening 228 can be expanded from an initial diameter in the range of about 7-9 mm to an expanded diameter in the range of about 9-12 mm. In one or more embodiments, as Figure 7 As shown, the elastomeric sealing ring 226 is in contact with the circumferential wall 218. In one or more embodiments, the male luer connector frictionally engages the expandable opening 228 of the elastomeric sealing ring 226 with a press-fit connection when inserted into the chamber 212 through the expandable opening 228. In one or more embodiments, the elastomeric sealing ring 226 is in contact with the circumferential wall 218.

[0081] In one or more embodiments, the opening 232 of the open end 210 adjacent the inner wall surface 224 is sized and adapted to accommodate the elastomeric sealing ring 226 in a press-fit connection. The elastomeric sealing ring 226 includes one or more undercuts and / or tapered surfaces 227 that provide improved adaptability to various types of connectors. Figure 7 As shown, the one or more undercuts and / or tapered surfaces 227 may be placed on the surface of the elastomeric sealing ring 226 that faces the expandable opening 228. Figure 7 As shown, the one or more undercuts and / or tapered surfaces 227 are placed on the surface of the elastomeric sealing ring 226 that faces the circumferential wall 218 .

[0082] The inner wall surface 224 includes internal threads 230 adjacent to the closed end 206. The internal threads 230 are sized and adapted to engage a female Luer connector. In one or more embodiments, the internal threads 230 adjacent to the closed end 206 of the cap 202 extend partially along the length of the inner wall surface 224 of the cap 202.

[0083] After the connectors are inserted through the expandable opening 228 of the elastomeric sealing ring 226, the absorbent material 214 and the disinfectant or antimicrobial agent come into contact with the male luer connector, the female luer connector, and the hemodialysis connector.

[0084] A peelable seal 250 is provided on the end face 216 of the lid 202 to prevent the disinfectant or antimicrobial agent from leaving the chamber 212 .

[0085] The inner wall surface 224 includes internal threads 230 adjacent to the closed end 206. The internal threads 230 are sized and adapted to engage a female Luer connector. After the connectors are inserted into the open end 210 of the cap 202, the absorbent material 214 and the disinfectant or antimicrobial agent come into contact with the male Luer connector, the female Luer connector, and the hemodialysis connector.

[0086] In one or more embodiments, the outer wall surface 222 of the cover 202 includes a plurality of gripping members.

[0087] The cover 202 includes an annular cover wall 208 having a cover wall length L extending from the closed end 206 of the cover to the open end 210 of the cover. C The cover 202 includes an inner wall surface 224 and an outer wall surface 222 .

[0088] A peelable seal 250 is provided on the open end 210 of the lid to prevent the disinfectant or antimicrobial agent from exiting the chamber 212 .

[0089] In one or more embodiments, the female connector can be selected from the group consisting of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector.

[0090] In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male lock Luer connector.

[0091] In one or more embodiments, the male luer connector rests on the circumferential abutment 218 when fully inserted into the chamber 212 .

[0092] In one or more embodiments, the internal threads 230 adjacent the closed end 206 of the cap 202 extend partially along the length of the inner wall surface 224 of the cap 202 .

[0093] In one or more embodiments, the male luer connector frictionally engages the inner wall surface 224 via a press-fit connection when inserted into the chamber 212 .

[0094] In one or more embodiments, the opening 232 adjacent the open end 210 of the inner wall surface 224 of the cap 202 is sized and adapted to receive a male luer connector for a press-fit connection.

[0095] The resilient sealing ring 226 comprises an elastomeric material.

[0096] In one or more embodiments, the elastomeric material of the elastomeric sealing ring 226 includes a thermoplastic elastomer.

[0097] In one or more embodiments, the chamber 212 includes a first portion 236 adjacent the closed end 206 having a first portion diameter D1 and a second portion 238 adjacent the open end 210 having a second portion diameter D2, the first portion 236 and the second portion 238 being in fluid communication with each other, and the first portion diameter D1 being smaller than the second portion diameter D2. In one or more embodiments, the annular wall 208 of the cover 202 is frustoconical.

[0098] The cover 202 is made of any of a variety of plastics, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic used in medical devices. In one or more embodiments, the cover 202 comprises polypropylene or polyethylene material. In one or more embodiments, the outer wall surface 222 includes a plurality of gripping members 234.

[0099] In one or more embodiments, the absorbent material 214 is radially compressed by the internal threads 230 to retain the absorbent material 214 within the chamber 212. In one or more embodiments, the absorbent material is retained within the chamber without being radially compressed by the internal threads. In one or more embodiments, the absorbent material 214 is a nonwoven material, foam, or sponge. In one particular embodiment, the foam is a polyurethane foam. In a particular embodiment, the absorbent material 214 is in the form of a foam plug.

[0100] When the device 200 is used on a Luer connector, disinfection can be achieved by integrating a disinfectant or antimicrobial agent into the chamber 212 of the cap 202. The disinfectant or antimicrobial agent can be contained directly in the chamber 212, or the disinfectant or antimicrobial agent can be absorbed into the sponge or foam material that fills the chamber 212 of the cap 202. The device 200 is designed to be compatible when interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctyl hydroquinone, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0101] When connected to a female or male luer connector, compression of the absorbent material 214 toward the closed end 206 of the chamber 212 allows the connector to contact a disinfectant or antimicrobial agent to sterilize the female or male luer connector.

[0102] In one or more embodiments, a peelable seal 250 may be placed on the end face 216 to prevent the disinfectant or antimicrobial agent from leaving the chamber 212 .

[0103] In one or more embodiments, the peelable seal 250 comprises an aluminum or multi-layer polymer film peelable back top. In certain embodiments, the peelable seal 250 is heat sealed or induction sealed to the open end of the lid. In one or more embodiments, the peelable seal 250 comprises a moisture barrier.

[0104] 8 to 11 , in one or more embodiments, the cap of the device of the present disclosure forms a fluid-tight seal with the female luer connector 300, the male luer connector 400, or the hemodialysis connector 500. Referring to FIG8 to 11 , in one or more embodiments, the cap of the device of the present disclosure is tapered to form a fluid-tight seal with the female luer connector 300 or the male luer connector 400. In certain embodiments, the cap complies with ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) to form a seal with the male luer connector 400.

[0105] In one or more embodiments, the cap of the device of the present disclosure has threads that are sized and pitched to engage with the threadable section of a female connector (e.g., a female Luer connector). Such connectors are commonly and typically used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, when the threads from the female Luer connector engage with the threads of the cap and form a releasable connection, the cap provides a protective cover for the female Luer connector when engaged with the female Luer connector.

[0106] In some embodiments, the connector includes a needle-free injection site, which may sometimes be referred to as a needle-free injection port, interface, valve, or device, or as a needle-free access site, port, interface, valve, or device, and which may include, 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 connected to any of a variety of different needle-free injection sites, such as those listed previously. In one or more embodiments, after the cap is connected to the connector, it is not necessary to disinfect the connector (e.g., with an alcohol swab) each time the connector is reconnected to another connector because the connector will be maintained in an uncontaminated state when connected to the cap. Use of the cap replaces the standard wiping regimen for cleaning the connector.

[0107] In one or more embodiments, the threads of the cap are sized and pitched to engage with the threads of a male Luer lock connector.For example, the connector may comprise an end of an intravenous tubing set that is disconnected from an intravenous catheter needle-free injection site.

[0108] Other aspects of the present disclosure are directed to methods of sterilizing medical connectors and assemblies. In one or more embodiments, a method of sterilizing a medical connector includes coupling a device of one or more embodiments to the medical connector, wherein coupling includes frictionally engaging an inner wall surface upon insertion into a cavity to contact the medical connector with an absorbent material and a disinfectant or antimicrobial agent.

[0109] In one or more embodiments, the assembly includes the device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male Luer connector, a female Luer connector, and a needleless connector.

[0110] Throughout this specification, references to "one embodiment," "certain embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of the present disclosure. Thus, phrases such as "in one or more embodiments," "in certain embodiments," "in one embodiment," or "in an embodiment" appearing throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, in one or more embodiments, the particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0111] Although the disclosure herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations may be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the present disclosure. Therefore, it is intended that the present disclosure include modifications and variations within the scope of the appended claims and their equivalents.

Claims

1. A medical assembly comprising a medical connector and a device connected to the medical connector, The medical connector is a male Luer connector, a female Luer connector, or a needleless connector; and The device for connecting to a medical connector includes a cover, an elastic sealing ring and a peelable seal, The cover comprises an integral body, a closed end, an annular wall having an outer wall surface and an inner wall surface and a length L extending from the closed end to the open end. C and defining a chamber, the chamber comprising: a first portion having a first portion diameter adjacent the closed end; and a second portion having a second portion diameter adjacent the open end, the first portion and the second portion being in fluid communication with each other, the first portion diameter being smaller than the second portion diameter, the chamber containing an absorbent material and a disinfectant or antimicrobial agent, the open end defining an end face and having a circumferential wall ledge extending radially inwardly from the annular wall, the open end defining an engagement surface; The elastomeric sealing ring is disposed in the second portion of the chamber and has an expandable opening; the expandable opening is sized to frictionally engage a male or female Luer connector having a compatible diameter; the inner wall surface including internal threads adjacent the closed end, the internal threads adapted and dimensioned to engage a female Luer connector; The peelable seal is located on the end surface; and 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.

2. The medical assembly according to claim 1, wherein The elastic sealing ring is in contact with the circumferential wall.

3. The medical assembly according to claim 1, wherein The expandable opening may have a diameter that is expandable from an initial diameter in the range of 7-9 mm to an expanded diameter in the range of 9-12 mm.

4. The medical assembly according to claim 1, wherein Internal threads adjacent the closed end extend partially along the length of the inner wall surface.

5. The medical assembly according to claim 1, wherein The male luer connector frictionally engages the expandable opening via a press-fit connection when inserted into the chamber.

6. The medical assembly according to claim 1, wherein The open end of the inner wall surface is sized and adapted to receive a resilient sealing ring in a press-fit connection.

7. The medical assembly according to claim 1, wherein The elastic sealing ring comprises an elastomeric material.

8. The medical assembly according to claim 7, wherein The elastomeric material comprises a thermoplastic elastomer.

9. The medical assembly according to claim 1, wherein The annular wall of the cover is frustoconical.

10. The medical assembly according to claim 1, wherein Compression of the absorbent material sterilizes the female Luer connector or the male Luer connector.

11. The medical assembly according to claim 1, wherein The absorbent material is radially compressed by the internal threads to retain the absorbent material within the chamber.

12. The medical assembly according to claim 1, wherein The disinfectant or antibacterial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, dichlorobenzyl alcohol, dehydroacetic acid, dioctyldodecyl, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics and mixtures thereof.

13. The medical assembly according to claim 1, wherein The disinfectant or antibacterial agent is alcohol.

14. The medical assembly according to claim 1, wherein The elastomeric sealing ring has one or more undercuts and an expandable opening therethrough, the expandable opening being sized and adapted to receive a male luer connector, a female luer connector, or a hemodialysis connector, the expandable opening being sized to frictionally engage with the male luer connector.

15. The medical assembly according to claim 14, wherein The one or more undercut portions are provided on a surface of the elastic sealing ring facing the expandable opening or facing the circumferential wall.

16. The medical assembly of claim 14, wherein: The one or more undercuts are provided on a surface of the elastic sealing ring facing the expandable opening and a surface of the elastic sealing ring facing the circumferential wall.

17. The medical assembly of claim 1, wherein: The expandable opening of the elastomeric sealing ring is sized and adapted to receive a male luer connector, a female luer connector, or a hemodialysis connector.

18. The medical assembly according to claim 17, wherein The inner diameter of the expandable opening is sized to frictionally engage a male luer connector.

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