Universal disinfection cap

Abstract

A device for connecting to a medical connector, the device comprising a cap, a coupling barrel adapted to engage with a male luer connector and a female luer connector, a bulbous chamber filled with air, an agent chamber filled with a disinfectant or antiseptic agent, and a passageway connecting the bulbous chamber with the agent chamber. The agent chamber comprises an outer wall surface, an inner wall surface, an array of resealable apertures integrated densely into the entire outer wall surface and inner wall surface of the agent chamber, and a distal tip. The passageway can be located in an orifice of a proximal end wall of the cap. The coupling barrel can comprise an O-ring.

Description

[0001] This application is a divisional of Chinese Patent Application No. 201980059886.8, filed on September 12, 2019, entitled “Universal Disinfecting Cap,” which is based on International Application No. PCT / US2019 / 050790, having an international filing date of September 12, 2019. TECHNICAL FIELD

[0002] The present disclosure relates generally to a device for disinfecting and sterilizing access ports with, for example, male and female luer connectors, and in particular to a disinfecting and sterilizing device capable of accommodating multiple types of connectors. BACKGROUND

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

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

[0005] Disinfecting caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and there are early indications that disinfecting caps will also be added to the Infusion Nurses Standards (INS) guidelines.

[0006] In developed markets, when an intravenous catheter is used, a needleless connector is typically used to close the system and subsequently accessed to administer medication or other necessary fluids through the catheter to the patient. The Infusion Nurses Standards recommend the use of needleless connectors and state that “constant and thorough disinfection with alcohol, iodine, or chlorhexidine and alcohol should be used prior to each access.” The ultimate goal of disinfecting the needleless connector is to help reduce bacteria that can be living on the surface and can cause various catheter-related complications, including the symptoms of catheter-related bloodstream infections previously mentioned. Nurses typically complete this disinfection task by using a 70% isopropyl alcohol pad to perform the well-known “dabbing of the access hub.” However, in general, nurses rarely adhere to this practice. In addition to the lack of adherence to “dabbing of the access hub,” through interviews with clinicians, it was noted that the time to dab, the time to dry, and the number of times the needleless connector is dabbed often varies.

[0007] There are many risks of contact or contamination throughout the entire procedure associated with the transmission of microorganisms that can lead to catheter-related bloodstream infections. Contamination can occur during drug mixing, cannula connection, and insertion into the access hub. Because the procedure of connecting a vascular access device is so common and simple, the risks associated with accessing a patient's vascular system are often overlooked. Currently, the risk to hospitals and patients is that clinicians do not connect with sufficient care and that the care is largely uncontrollable.

[0008] Current market disinfection caps are only able to disinfect one of three types of luer connectors (i.e., female luer connectors of needleless connectors, female luer connectors of stopcock valves, and male luer connectors at intravenous injection sites). Currently, disinfection caps for needleless male connectors, needleless female connectors, intravenous (IV) and hemodialysis lines use different designs and are therefore limited to the type of connector to which the disinfection cap can be attached. Prior art disinfection caps are designed to only work with one type of connector and are specific to one particular size and / or shape of connector. While some current market disinfection caps are intended for use with a closed female luer on a needleless connector and they can often also fit an open female luer on a stopcock valve, current market disinfection caps are not able to disinfect the internal cavity of a stopcock valve. Current market disinfection caps are not able to attach to male and female connectors when disinfecting the internal cavity of an open female luer connector. Therefore, there is a need for a disinfection device that is able to accommodate multiple types of connectors, including male and female connectors, to simplify the disinfection process. SUMMARY

[0009] One aspect of the disclosure relates to a device for connecting to a medical connector. The device according to the second exemplary embodiment of the disclosure generally includes a cap body, a coupling barrel, a bulbous chamber, a reagent chamber, and a passageway connecting the bulbous chamber with the reagent chamber. The cap body includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal end wall having an aperture. The sidewall has a length L extending from the proximal end to the open distal end. O1 The open distal end defines an end face.

[0010] In one or more embodiments, the coupling barrel includes a sidewall having an inner surface that mates with an outer threaded surface of a female connector or a hemodialysis connector, an outer surface that mates with a threaded surface of a collar on a male connector, a distal end, and a proximal end.

[0011] In one or more embodiments, the bulbous chamber is filled with air.

[0012] The reagent chamber defines a cavity that contains a disinfectant or antiseptic. The reagent chamber includes an outer wall surface, an inner wall surface, an array of resealable apertures integrally populated into the outer wall surface and the inner wall surface of the reagent chamber, and a distal terminus.

[0013] In one or more embodiments, the channel is located in the orifice of the proximal wall.

[0014] In one or more embodiments, the distal end of the coupling barrel includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0015] In one or more embodiments, the open distal end of the cap body is located at substantially the same horizontal plane P as the distal terminus of the reagent chamber, or less than 8 mm from the open distal end of the cap body, in the initial state, such that when the female or male luer connector is engaged to the device, the reagent chamber is compressed and the reagent chamber retracts towards the proximal wall.

[0016] In one or more embodiments, the disinfectant or antiseptic is released from the reagent chamber by compression of the chamber to disinfect the female or male luer connector. In one or more embodiments, the disinfectant or antiseptic is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof.

[0017] In one or more embodiments, the disinfectant or antiseptic is a fluid or a gel.

[0018] In one or more embodiments, the female luer connector is selected from the group consisting essentially of needleless connectors, stopcocks, and hemodialysis connectors.

[0019] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0020] In one or more embodiments, the device further includes a peelable seal on the open end of the cap body.

[0021] In one or more embodiments, the peelable seal can include a peel-off top made of aluminum or a multi-layer polymer film.

[0022] The device according to the second exemplary embodiment of the disclosure generally includes a cap, a coupling barrel, a bulb-shaped chamber, a reagent chamber, and a passage connecting the bulb-shaped chamber with the reagent chamber. The cap includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal end wall having an aperture. The sidewall has a length L extending from the proximal end to the open distal end O1 . The open distal end defines an end face.

[0023] In one or more embodiments, the coupling barrel includes a sidewall having an inner surface that mates with an outer threaded surface of a female connector or a hemodialysis connector, an outer surface that mates with a threaded surface of a collar on a male connector, a distal end, and a proximal end. The coupling barrel can be made of a semi-rigid material, such as: a thermoplastic elastomer (TPE); a polypropylene (PP) / thermoplastic elastomer (TPE) blend; or a polyethylene (PE) / thermoplastic elastomer (TPE) blend; or a polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating or other blends of plastic and thermoplastic elastomer; a thermoplastic elastomer (TPE) or rubber-like elastic. In one or more embodiments, the coupling barrel can be manufactured using a secondary molding process.

[0024] In one or more embodiments, the bulb-shaped chamber is filled with air.

[0025] The reagent chamber defines a cavity that contains a disinfectant or an antiseptic. The reagent chamber includes an outer wall surface, an inner wall surface, an array of resealable apertures integrally populated into the outer wall surface and the inner wall surface of the reagent chamber, and a distal terminus.

[0026] In one or more embodiments, the passage is located in the aperture of the proximal end wall.

[0027] In one or more embodiments, the distal end of the coupling barrel includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0028] In one or more embodiments, the sidewall of the coupling barrel includes one or more leaf springs.

[0029] In one or more embodiments, the open distal end of the cap is located at substantially the same horizontal plane P as the distal terminus of the reagent chamber in an initial state, or is less than 8 mm from the open distal end of the cap, such that when the female or male luer connector is engaged to the device, the reagent chamber is compressed and the reagent chamber retracts towards the proximal end wall.

[0030] In one or more embodiments, the disinfectant or antiseptic is released from the reagent chamber through the compression chamber to disinfect the female luer connector or male luer connector. In one or more embodiments, the disinfectant or antiseptic is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof.

[0031] In one or more embodiments, the disinfectant or antiseptic is a fluid or a gel.

[0032] In one or more embodiments, the female luer connector is selected from the group consisting essentially of needleless connectors, stopcocks, and hemodialysis connectors.

[0033] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0034] In one or more embodiments, the device further comprises a peelable seal on the open end of the cap.

[0035] In one or more embodiments, the peelable seal can comprise a peel top made of aluminum or a multi-layer polymer film.

[0036] The device according to the third exemplary embodiment of the disclosure generally comprises a cap, a coupling barrel, a bulbous chamber, a reagent chamber, and a passageway connecting the bulbous chamber with the reagent chamber. The reagent chamber defines a cavity containing a disinfectant or antiseptic. The reagent chamber comprises an outer wall surface, an inner wall surface, an array of resealable apertures integrally populated into the outer wall surface and the inner wall surface of the reagent chamber, a permeable membrane disposed between the outer wall surface and the inner wall surface of the reagent chamber, and a distal terminus.

[0037] The cap comprises a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The sidewall has a length L extending from the proximal end to the open distal end. O1 The open distal end defines an end face.

[0038] In one or more embodiments, the coupling barrel comprises a sidewall having an inner surface that mates with an outer threaded surface of the female connector or hemodialysis connector, an outer surface that mates with a threaded surface of a collar on the male connector, a distal end, and a proximal end.

[0039] In one or more embodiments, the bulbous chamber is filled with air.

[0040] In one or more embodiments, the channel is located in an aperture of the proximal wall.

[0041] In one or more embodiments, the distal end of the coupling barrel includes an O-ring. In one or more embodiments, the O-ring is made of an elastomeric material.

[0042] In one or more embodiments, the sidewall of the coupling barrel includes one or more leaf springs.

[0043] In one or more embodiments, the open distal end of the cap body is located at approximately the same horizontal plane P as the distal end of the reagent chamber in the initial state.

[0044] In one or more embodiments, when the female or male luer connector is engaged to the device of the present disclosure, the reagent chamber is compressed and the reagent chamber is retracted towards the proximal wall.

[0045] In one or more embodiments, a disinfectant or antiseptic is released from the reagent chamber by compression of the chamber to disinfect the female or male luer connector. In one or more embodiments, the disinfectant or antiseptic is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof.

[0046] In one or more embodiments, the disinfectant or antiseptic is a fluid or a gel.

[0047] In one or more embodiments, the female luer connector is selected from the group consisting essentially of needleless connectors, stopcocks, and hemodialysis connectors.

[0048] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0049] In one or more embodiments, the device further includes a peelable seal on the open end of the cap body. In one or more embodiments, the peelable seal includes a peel top made of aluminum or a multi-layer polymer film.

[0050] A device according to a fourth exemplary embodiment of the present disclosure generally includes a cap body, a coupling barrel having a sidewall made of a thin metal sheet, a bulbous chamber, a reagent chamber, and a channel connecting the bulbous chamber with the reagent chamber. In one or more embodiments, the channel is located in an aperture of the proximal wall. In one or more embodiments, the metal sheet of the coupling barrel has perforations or mesh.

[0051] The cap includes a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end. The proximal end includes a proximal end wall. In one or more embodiments, the proximal end wall includes an aperture. In one or more embodiments, the sidewall has a length L extending from the proximal end to the open distal end O1 In one or more embodiments, the open distal end defines a face.

[0052] In one or more embodiments, the sidewall of the coupling barrel includes an inner surface that mates with an outer threaded surface of a female connector or hemodialysis connector, an outer surface that mates with a threaded surface of a collar on a male connector, a distal end, and a proximal end.

[0053] In one or more embodiments, the bulbous chamber is filled with air.

[0054] The reagent chamber defines a cavity that houses a disinfectant or antiseptic. In one or more embodiments, the reagent chamber has an outer wall surface, an inner wall surface, an array of resealable apertures integrated densely into the outer wall surface and the inner wall surface of the reagent chamber, and a distal terminus. BRIEF DESCRIPTION OF DRAWINGS

[0055] Figure 1 A perspective view of a device according to a first embodiment is shown;

[0056] Figure 2 A perspective view of a device according to a second embodiment is shown;

[0057] Figure 3 A perspective view of Figure 2 A side cross-sectional view of the device shown;

[0058] Figure 4 A side cross-sectional view of a device according to a second embodiment is shown;

[0059] Figure 5 A side view of a device according to a second embodiment is shown;

[0060] Figure 6 A side view of Figure 2 A side cross-sectional view of the device shown;

[0061] Figure 7 A plan view of Figure 2 A plan view of the device shown;

[0062] Figure 8 A plan view of Figure 2 A side view of the device shown;

[0063] Figure 9 A side view of Figure 2 A schematic view of a wall of a reagent chamber of the device shown;

[0064] Figure 10 a male luer connector according to the prior art Figure 2 a plan view of the device shown;

[0065] Figure 11 a male luer connector according to the prior art Figure 2 a plan view of the device shown;

[0066] Figure 12 a male luer connector according to the prior art Figure 2 a plan view of the device shown;

[0067] Figure 13 a cross-sectional view of a device according to a third embodiment, wherein the device has a permeable membrane covering the boundary material of the chamber;

[0068] Figure 14 a schematic view of the wall of the reagent chamber of the device shown in Figure 13

[0069] a schematic view of the wall of the reagent chamber of the device shown in Figure 15 Figure 13 a schematic view of the wall of the reagent chamber of the device shown in

[0070] Figure 16 a schematic view of the wall of the reagent chamber of the device shown in Figure 13

[0071] a male luer connector according to the prior art Figure 17 a plan view of the device shown; Figure 13

[0072] a schematic view of the wall of the reagent chamber of the device shown in Figure 18 Figure 17

[0073] Figure 19 a male luer connector according to the prior art Figure 13 a plan view of the device shown;

[0074] Figures 20a-20e show perspective views of a device according to a fourth embodiment, wherein the coupling barrel is a thin sheet of metal. DETAILED DESCRIPTION

[0075] Before several exemplary embodiments of the present disclosure are described, it is to be understood that the present disclosure is not limited to the details of construction or method steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

[0076] ​​​Embodiments of the present disclosure relate to a universal disposable device for connecting to and disinfecting medical male and female connectors including male and female luer connectors. In one or more embodiments, the universal disposable device includes a disinfecting cap that can be adapted to a wide range of luer fittings including closed female luer, open female luer, and male luer fittings, while being able to disinfect medical equipment such as access ports including needleless connectors, male luer connectors on intravenous lines, male luer connectors on intravenous extension tubing, stopcocks, and hemodialysis connectors. The device contains a disinfectant or antiseptic for disinfection. The device of the present disclosure allows practitioners to simplify the disinfection process.

[0077] With respect to the terms used in the present disclosure, the following definitions are provided.

[0078] As used herein, the use of "a," "an," and "the" includes singular and plural.

[0079] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or intravenous line.

[0080] In the present disclosure, the convention is followed where the distal end of the device is the end closest to the patient, and the proximal end of the device is the end away from the patient and closest to the physician.

[0081] The term "compressible" refers to a wall or container configured to have sufficient flexibility to at least partially fold into an interior chamber upon manual pressing. The shape and extent of deformation will vary with the various configurations of the wall, container, or chamber.

[0082] As used herein, the term "luer connector" refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, intravenous tubing, and the like to one another. Luer connectors consist of male and female interlocking tubing that are held together by slight tapering through even just a simple pressure / torque fit. Luer connectors can optionally include an additional outer threaded rim, making them more secure. The male end of a luer connector is typically associated with a flush syringe and is capable of interlocking and connecting 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, a shaped central passage for fluid communication from the chamber of the barrel of the syringe to the hub of the vascular access device. The luer connector also has a distal passage that releasably attaches the luer connector to the distal end of the hub of the vascular access device, and a proximal passage that releasably attaches the luer connector to the barrel of the syringe.

[0083] Reference is made to Figure 1The device 10 serves as a cap to be mounted onto a connector and is capable of being attached to the connector for an extended period of time. The device 10 for connection to a medical connector according to a first exemplary embodiment of this disclosure typically includes a cap body 20, a connecting tube 30, a bulbous chamber 60, a reagent chamber 50, and a channel 70 connecting the bulbous chamber 60 to the reagent chamber 50. The cap body 20 serves as a support for mechanically supporting the device. The cap body includes a sidewall 21 having an outer surface 22 and an inner surface 23, an open distal end 24, and a proximal end 25. The proximal end 25 of the cap body 20 includes a proximal wall 26 having an orifice 27. In one or more embodiments, the channel is located in the orifice of the proximal wall.

[0084] The sidewall 21 has a length L extending from the proximal end 25 to the open distal end 24. sw The open distal end 24 defines an end face. In one or more embodiments, as... Figure 1 As shown, the cap body 20 is a cylindrical shape with an opening 29. The opening 29 of the cap body 20 allows the connector to enter the connecting tube 30 and the chamber 50 containing the antibacterial agent. The cap body 20 serves as a support to which the bulbous chamber 60 and the reagent chamber 50 are attached. In one or more embodiments, the bulbous chamber 60 and the reagent chamber 50 are attached through an opening 27 in the proximal wall 26 of the proximal end 25 of the cap body 20. The cap body 20 also serves as a mechanical barrier to prevent the reagent chamber 50 from being compressed due to negligence. The cap body 20 is made of a rigid material, including polypropylene, high-density polyethylene (HDPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, or a polyethylene (PE) / thermoplastic elastomer (TPE) blend, or a polypropylene (PP) / polyethylene (PE) material having a thermoplastic elastomer (TPE) coating. In one or more embodiments, the cap body can be manufactured using a two-stage molding process. In one or more embodiments, the device may further include a peelable seal on the open distal end 24 of the cap 20. In one or more embodiments, the peelable seal may include a peelable top made of aluminum or a multilayer polymer film.

[0085] The connecting sleeve 30 is used to engage the threaded surfaces of a Luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female Luer connector of a stopcock valve, and the threaded surface of a collar of a male connector. The connecting sleeve 30 is a cylindrical structure with sidewalls 31 having an inner surface 32 that mates with the external threaded surface of an open or closed female connector or hemodialysis connector, an outer surface that mates with the threaded surface of a collar on the male connector, an open distal end 34, and a proximal end 36. In one or more embodiments, the female Luer connector may be a needleless connector, a stopcock valve, or a hemodialysis connector. In one or more embodiments, the male connector may be an end of an intravenous fitting or a stopcock valve.

[0086] The coupling barrel can be made of a semi-rigid material, such as: thermoplastic elastomer (TPE); polypropylene (PP) / thermoplastic elastomer (TPE) mixture; polyethylene (PE) / thermoplastic elastomer (TPE) mixture; polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating or other mixtures of plastic and thermoplastic elastomer; thermoplastic elastomer (TPE) or rubber similar elasticity. In one or more embodiments, the coupling barrel can be manufactured using a secondary molding process.

[0087] In one or more embodiments, the coupling barrel 30 is placed concentrically within the cap body 20 and attached to the proximal end 25 of the cap body 20. The coupling barrel 30 is a deformable but structurally rigid coupling device to match the geometry of different types of luer connectors. In one or more embodiments, the coupling barrel 30 is made of an elastomeric material. The coupling barrel 30 has an open cavity on the open distal end 34 on the same side as the open cavity 29 of the cap body 20.

[0088] In one or more embodiments, the open distal end 34 of the coupling barrel 30 includes an O-ring 35. In one or more embodiments, the O-ring 35 is integrated at the open distal end of the coupling barrel 30 for a tight grip on the connector surface. At the open end of the open cavity, the edge of the cylindrical coupling device forms the O-ring 35 to enhance the grip tightness of the joint between the coupling barrel 30 and the connector surface. The O-ring 35 is also used to form a seal for the purpose of forming a closed space between the connector and the coupling barrel 30. The O-ring structure 35 at the open distal end 34 of the coupling barrel 30 is able to seal any liquid reagent that is to exit from the reagent chamber to prevent leakage of the reagent when the device 10 is installed onto the connector. In one or more embodiments, the O-ring 35 is made of an elastic material that is flexible and maintains its original shape in the initial state. Upon insertion of the connector with the coupling barrel 30, the O-ring 35 expands to accommodate the connector, thereby forming a tight seal around the connector. Upon removal of the connector, the O-ring 35 returns to its initial state.

[0089] Another challenge for a disinfecting cap to effectively disinfect different types of connectors, in addition to the luer engagement, is to be able to conform to different geometrical shaped surfaces, including the flat surface of a closed female luer with a septum embedded center, the cavity of an open female luer of a stopcock valve, and the protrusion of a male luer. To enable effective disinfection for various luer types, embodiments of the present disclosure have a compressible reagent chamber 50 that is flexible to conform to different types of surfaces that need disinfection.

[0090] The reagent chamber 50 defines a chamber that contains a disinfectant or antiseptic. The reagent chamber 50 includes an outer wall surface 52, an inner wall surface 54, an array of resealable pores integrally populated into the outer wall surface 52 and the inner wall surface 54 of the reagent chamber 50, and a distal tip 58. The boundary material of the reagent chamber 50 has a plurality of integrally populated micron- or nanometer-sized pores 56 embedded in the polymer matrix of the reagent chamber 50 to release the reagent. The boundary material of the side wall 51 of the reagent chamber has perforations through the integrally populated resealable pores. The pores 56 open when pressure is applied to the boundary side wall 51. This opening of the pores 56 is reversible. The reagent chamber 50 can be activated by compressing the bulbous chamber 60 that protrudes above the cap 20. When the bulbous chamber 60 is squeezed, the disinfectant or antiseptic in the reagent chamber 50 is forced through the micron- or nanometer-sized pores 56 embedded in the polymer matrix of the reagent chamber 50 due to the pressure rise caused by the compressed air. In one or more embodiments, the open distal end 24 of the cap 20 is in the initial state at approximately the same horizontal plane P as the distal tip 58 of the reagent chamber 50, or less than 8 mm from the open distal end of the cap, such that when a female or male luer connector is engaged to the device 10, the reagent chamber 50 is compressed and the reagent chamber 50 retracts toward the proximal wall 26. The reagent chamber 50 is composed of a reversible deformable material that assembles onto the cap 20 to enable fitting onto a male or female luer connector, hold a volume of disinfectant or antiseptic, release the disinfectant or antiseptic in a controlled manner, seal the released disinfectant or antiseptic in an enclosed space, and reduce fluid ingress by blocking the fluid path. In one or more embodiments, the reagent chamber 50 is made of an elastomeric material.

[0091] The reagent chamber 50 containing a disinfectant or antiseptic is capable of releasing the disinfectant or antiseptic when compressed. The reagent chamber 50 takes the form of a cylinder with a conical distal tip and constitutes a lower compressible chamber surrounded by the coupling barrel 30. The reagent chamber 50 can function as a protrusion that is inserted into an open female luer connector while it is used for the ability to retract upon compression of the protrusion of the closed female luer connector and male luer connector. In one or more embodiments, the reagent chamber 50 is pre-filled or pre-loaded with a disinfectant or antiseptic. In one or more embodiments, the reagent chamber 50 is connected to the bulbous chamber 60. In one or more embodiments, the boundary material of the reagent chamber 50 and the bulbous chamber 60 is composed of a stretchable material such as an elastomer (e.g., a thermoplastic elastomer).

[0092] In one or more embodiments, one or both of the reagent chamber 50 and the bulb chamber 60 are compressible to exert pressure on the disinfectant or antiseptic to facilitate release of the disinfectant or antiseptic. The reagent chamber 50 is also compressible and deforms automatically to match the geometry of different types of male or female connectors when the device 10 is installed onto a male or female connector. In one or more embodiments, the bulb chamber 60 is made of an elastomeric material. In one or more embodiments, the disinfectant or antiseptic is released from the reagent chamber 50 by compressing the reagent chamber 50 to disinfect a female or male luer connector.

[0093] Upon pressure removal, the aperture automatically reseals itself due to the elastic properties of the boundary material, thereby reforming the barrier to prevent leakage of the disinfectant or antiseptic from the reagent chamber 50. The distal tip of the reagent chamber serves as a fluid path blocking device to block the antiseptic from entering when the distal tip is compressed on the access port of a male luer connector when the device 10 is installed onto a male connector. In one or more embodiments, the distal tip of the reagent chamber 50 is conically shaped and is firmly constructed of an elastomeric material for blocking the fluid path. The distal tip of the reagent chamber provides a mechanism to block the fluid path in a closed female and male connector to prevent the disinfectant or antiseptic from entering the chamber of the respective female or male connector. In one or more embodiments, the reagent chamber 50 is insertable into the inner lumen of a stopcock valve. The outer diameter of the distal tip of the reagent chamber 50 is compatible with the outer diameter of an open female luer connector. The distal tip 58 can be compressed by a male luer connector and a closed female luer connector. Upon compression, the encapsulated disinfectant or antiseptic retracts into the bulb chamber 60.

[0094] As will be discussed in detail later in this disclosure, embodiments of the device of the present disclosure enable disinfection to be applied to various connectors. When the device 10 is installed onto a closed female luer on a needleless connector or a hemodialysis connector, the reagent chamber 50 is compressed on the face of the connector or on the surface of a septum embedded in the connector. This compression causes an increase in pressure within the reagent chamber, which further releases the disinfectant or antiseptic to disinfect the face of the needleless connector and the luer threads. When the device 10 is installed onto an open female luer, such as a female luer of a stopcock valve, the reagent chamber 50, which has a shape similar to that of a male luer, can be complementarily inserted into the open female luer. By compressing the bulb chamber 60, the disinfectant or antiseptic can be released into the inner lumen of the stopcock valve. When a cap is installed onto a male connector, the distal tip at the end of the reagent chamber 50 contacts the luer port, blocking the port entrance to prevent the subsequently released disinfectant or antiseptic from entering the inner lumen, thus reducing disinfectant or antiseptic ingress. Compression of the reagent chamber 50 on a male luer connector causes release of the antiseptic for disinfection.

[0095] When the reagent chamber 50 is deformed or the bulbous chamber 60 is compressed, pressure is applied to the disinfectant or antiseptic, causing the disinfectant or antiseptic to be expelled from the reagent chamber into the area 59 outside the reagent chamber to disinfect the surface of the connector to which the device 10 is attached. The disinfectant or antiseptic can be retained in the space 59 outside the reagent chamber by the O-ring seal 35. The front end of the reagent chamber 50 also has a sealing component that can block the fluid passage to prevent the entry of the antiseptic. In one or more embodiments, the device has one open cavity and has a coupling mechanism that automatically fits different types of connectors by simple installation movement. The reagent chamber preloaded with the antiseptic can be deformed to conform to different geometries of different types of connectors. The release of the antiseptic can be controlled by the deformation of the reagent chamber 50 or the compressible bulbous chamber 60. The disinfectant or antiseptic that has been released but retained can disinfect the connector port for a long time.

[0096] The reagent chamber 50 is designed to be compatible when interacting with various disinfectants or antiseptics. In one or more embodiments, the disinfectant or antiseptic can include alcohol or a variant of chlorhexidine. The disinfectant or antiseptic can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, isopropyl alcohol, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzalkonium chloride, octenidine, octenidine dihydrochloride, antibiotics, and mixtures thereof. The reagent fills the chamber 50 containing the antiseptic, which constitutes the lower chamber partially surrounded by the coupling barrel 30, while the upper part of the chamber 50 containing the antiseptic is filled with air. The chamber 50 containing the antiseptic is composed of a stretchable material such as an elastomer (e.g., a thermoplastic elastomer).

[0097] In one or more embodiments, the reagent chamber 50 contains both air and a liquid reagent, where during insertion of the male or female connector, the air pressure on the liquid disinfectant or antiseptic in the reagent chamber caused by the compression of the bulbous chamber 60 or the compression of the elastomeric material of the reagent chamber 50 results in the opening of the pores, which in turn releases the antiseptic.

[0098] In one or more embodiments, as Figure 1As shown, the compressible bulbous chamber 60 protrudes above the cap 20. In one or more embodiments, the bulbous chamber is filled with air or gas and is connected to the reagent chamber 50. When the reagent chamber 50 is compressed, the pressure in the bulbous chamber 60 increases, thereby releasing the disinfectant or antiseptic from the reagent chamber 50. The degree of pressure increase depends on the elasticity of the boundary material of the reagent chamber 50 and the bulbous chamber 60. The bulbous chamber 60 also provides for additional control by adjusting the pressure within the reagent chamber 50 and the bulbous chamber 60. By manually compressing the bulbous chamber 60, additional disinfectant or antiseptic can be released from the reagent chamber 50, thereby disinfecting the connector. In one or more embodiments, the bulbous chamber 60 is made of an elastomeric material.

[0099] In one or more embodiments, as shown, Figure 1 the coupling barrel 30, the reagent chamber 50, and the bulbous chamber 60 can be mechanically connected and can be formed as one piece. In one or more embodiments, the boundary of the bulbous chamber 60 and the reagent chamber 50 can be joined by ultrasonic welding or adhesive. In an alternative embodiment, the coupling barrel 30, the reagent chamber 50, and the bulbous chamber 60 constitute components of three different structures.

[0100] Due to the deformable coupling barrel 30 that is capable of forming a seal on both male and female luer connectors, embodiments of the device 10 of the present disclosure are self-adaptable to different types of luer connectors. The device 10 is also capable of deforming the shape of the reagent chamber 50 to accommodate male connectors, closed female connectors, and open female connectors, thereby achieving effective disinfection not only on the outer surface of the luer but also on the inner cavity of the open female luer.

[0101] In one or more embodiments, a removable seal is attached to the open end of the cap to maintain the sterility of the distal tip, the inner cavity, and the open distal end.

[0102] Referring to Figures 2-8 , the device 10 functions as a cap to be mounted onto a connector and is capable of being attached to the connector for an extended period of time. The device 10 for connecting to a medical connector according to the first exemplary embodiment of the present disclosure generally includes a cap 20, a coupling barrel 30, a bulbous chamber 60, a reagent chamber 50, and a passage 70 connecting the bulbous chamber 60 with the reagent chamber 50. The cap 20 functions as a holder that mechanically supports the device. The cap includes a sidewall 21 having an outer surface 22 and an inner surface 23, an open distal end 24, and a proximal end 25. The proximal end 25 of the cap 20 includes a proximal end wall 26 having an aperture 27. In one or more embodiments, the passage is located in the aperture of the proximal end wall.

[0103] The sidewall 21 has a length L swThe open distal end 24 defines an end face. In one or more embodiments, as shown Figures 2-4 The cap 20 is cylindrical in shape with an open cavity 29. As shown Figures 10-13 The open cavity 29 of the cap 20 allows access to the coupling barrel 30 and the chamber 50 containing the antimicrobial agent. The cap 20 serves as a cradle for the bulbous chamber 60 and reagent chamber 50 to be attached thereto. In one or more embodiments, the bulbous chamber 60 and reagent chamber 50 are attached through an aperture 27 in the proximal end wall 26 of the proximal end 25 of the cap 20. The cap 20 also serves as a mechanical barrier to prevent the reagent chamber 50 from being compressed by accident. The cap 20 is constructed of a rigid material including: polypropylene; high-density polyethylene (HDPE); polypropylene (PP) / thermoplastic elastomer (TPE) blend; polyethylene (PE) / thermoplastic elastomer (TPE) blend; or polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating. In one or more embodiments, the cap can be manufactured using a two-shot molding process. In one or more embodiments, the device can also include a peelable seal on the open distal end 24 of the cap 20. In one or more embodiments, the peelable seal can include an aluminum or multi-layer polymer film peel top.

[0104] The coupling barrel can be made of a semi-rigid material such as thermoplastic elastomer (TPE); polypropylene (PP) / thermoplastic elastomer (TPE) blend; polyethylene (PE) / thermoplastic elastomer (TPE) blend; polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating or other mixtures of plastic and thermoplastic elastomer; or thermoplastic elastomer (TPE) or rubber with similar elasticity. In one or more embodiments, the coupling barrel can be manufactured using a two-shot molding process.

[0105] The coupling barrel 30 is used to engage the threaded surface of a luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock, and the threaded surface of a collar of a male connector. The coupling barrel 30 is a cylindrical structure with a sidewall 31 having an inner surface 32 that mates with the outer threaded surface of an open or closed female connector or a hemodialysis connector, an outer surface 33 that mates with the threaded surface of a collar on a male connector, an open distal end 34, and a proximal end 36. In one or more embodiments, the female luer connector can be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0106] In one or more embodiments, the coupling barrel 30 is placed concentrically within the cap body 20 and is attached to the proximal end 25 of the cap body 20. The coupling barrel 30 is a deformable but structurally rigid coupling device to match the geometry of different types of luer connectors. In one or more embodiments, the coupling barrel 30 is made of an elastomeric material. The coupling barrel 30 has an open cavity on its open distal end 34 on the same side as the open cavity 29 of the cap body 20. In one or more embodiments, the coupling barrel 30 is constructed with a structure that combines the flexibility of an elastomer and the rigidity of a metallic material, enabling it to adapt to the geometry of different types of connectors while maintaining a tight grip on the connector to prolong the sterilization time. In one or more embodiments, one or more leaf springs 40 are integrated into the sidewall 31 of the coupling barrel 30 to provide mechanical strength to maintain the original form of the sealed coupling barrel 30 and overcome the deformation forces exerted by the connector when the coupling barrel 30 is installed onto a male or female connector. The leaf springs 40 can be embedded in the material of the sidewall 31 of the coupling barrel 30, embedded in grooves in the material of the sidewall 31 of the coupling barrel 30, or inserted during the molding process or attached by adhesive into the sidewall 31 of the coupling barrel 30. In one or more embodiments, the leaf springs 40 are embedded longitudinally in the thin sidewall 31 of the coupling barrel 30 to provide rigidity and structural strength to maintain the shape integrity of the coupling device when the cap is installed onto the threaded surface of the connector. The leaf springs 40 can be made of a rigid but deformable material including thin sheets of stainless steel or metal alloys. The leaf springs 40 can take the form of a rectangle with a high geometric aspect ratio. An array of 4 to 6 leaf springs 40 can be embedded in the wall of the coupling barrel 30 with equal angular dispersion, and the array can be axially symmetric around the central axis of the coupling barrel 30.

[0107] In one or more embodiments, the open distal end 34 of the coupling barrel 30 includes an O-ring 35. In one or more embodiments, the O-ring 35 is integrated into the open distal end of the coupling barrel 30 for a tight grip on the connector surface. At the open end of the open cavity, the edge of the cylindrical coupling device forms the O-ring 35 to enhance the gripping tightness of the joint between the coupling barrel 30 and the connector surface. The O-ring 35 also serves to form a seal for the purpose of creating a closed space between the connector and the coupling barrel 30. The O-ring structure 35 at the open distal end 34 of the coupling barrel 30 is able to seal any liquid reagent that is to exit from the reagent chamber to prevent leakage of the reagent when the device 10 is installed onto the connector. In one or more embodiments, the O-ring 35 is made of an elastic material that is flexible and maintains its original shape in the initial state. Upon insertion of the connector with the coupling barrel 30, the O-ring 35 expands to accommodate the connector, thereby forming a tight seal around the connector. Upon removal of the connector, the O-ring 35 returns to its initial state.

[0108] In addition to the luer engagement, another challenge for the disinfecting cap to effectively disinfect different types of connectors is to be able to conform to different geometrical surfaces, including the flat surface of a closed female luer with a septum-embedded center, the open cavity of an open female luer of a stopcock valve, and the protrusion of a male luer. To enable effective disinfection for various luer types, embodiments of the present disclosure have a compressible reagent chamber 50 that is flexible to conform to different types of surfaces that need disinfection.

[0109] The reagent chamber 50 defines a cavity that houses a disinfectant or an antimicrobial agent. The reagent chamber 50 includes an outer wall surface 52, an inner wall surface 54, an array of resealable pores 56 integrally populated into the outer wall surface 52 and the inner wall surface 54 of the reagent chamber 50, and a distal tip 58. The boundary material of the reagent chamber 50 has a large number of integrally populated micron- or nanometer-sized pores 56 embedded in the polymer matrix of the reagent chamber 50 to release the reagent. Due to these densely populated self-resealable pores, the boundary material of the side wall 51 of the reagent chamber has perforations. As shown in Figures 8-9 The opening of the pores 56 is reversible. The reagent chamber 50 can be activated by compressing the bulbous chamber 60 that protrudes above the cap body 20. When the bulbous chamber 60 is squeezed, the disinfectant or antimicrobial agent in the reagent chamber 50 is forced by the compressed air to rise in pressure, thereby releasing the disinfectant or antimicrobial agent through the micron- or nanometer-sized pores 56 embedded in the polymer matrix of the reagent chamber 50. In one or more embodiments, the open distal end 24 of the cap body 20 is in the initial state at approximately the same horizontal plane P as the distal tip 58 of the reagent chamber 50, such that when a female luer connector or a male luer connector is engaged to the device 10, the reagent chamber 50 is compressed, and the reagent chamber 50 retracts toward the proximal wall 26. The reagent chamber 50 is composed of a reversible deformable material that is assembled onto the cap body 20 to enable fitting onto a male luer connector or a female luer connector, holding a volume of disinfectant or antimicrobial agent, releasing the disinfectant or antimicrobial agent in a controlled manner, sealing the released disinfectant or antimicrobial agent in an enclosed space, and reducing fluid ingress by blocking the fluid path. In one or more embodiments, the reagent chamber 50 is made of an elastomeric material.

[0110] As Figures 9-12As shown, the reagent chamber 50, containing a disinfectant or antibacterial agent, is capable of releasing the disinfectant or antibacterial agent upon compression. The reagent chamber 50 is in the form of a cylinder with a conical distal end 58 and constitutes a lower compressible chamber surrounded by a connecting cylinder 30. The reagent chamber 50 can be used as a protrusion inserted into an open female Luer connector, while being retractable upon compression against the protrusions of a closed female Luer connector and a male Luer connector. In one or more embodiments, the reagent chamber 50 is pre-filled or pre-loaded with a disinfectant or antibacterial agent. In one or more embodiments, the reagent chamber 50 is connected to a bulb-shaped chamber 60. In one or more embodiments, the boundary material between the reagent chamber 50 and the bulb-shaped chamber 60 is made of a stretchable material such as an elastomer (e.g., a thermoplastic elastomer).

[0111] In one or more embodiments, one or both of the reagent chamber 50 and the bulb-shaped chamber 60 are compressed to apply pressure to the disinfectant or antimicrobial agent, thereby facilitating its release. The reagent chamber 50 is also compressible and automatically deforms to match the geometry of different types of male or female connectors when the device 10 is mounted onto a male or female connector. In one or more embodiments, the bulb-shaped chamber 60 is made of an elastomeric material. In one or more embodiments, the disinfectant or antimicrobial agent is released from the reagent chamber 50 by compressing it to sterilize the female or male Luer connector.

[0112] like Figure 9 As shown, upon pressure removal, due to the elastic properties of the boundary material, the orifice 56 automatically reseals itself, thus... Figures 8-9 The device is designed to reform a barrier to prevent leakage of disinfectant or antimicrobial agent from reagent chamber 50. The distal end 58 acts as a fluid path barrier, thus preventing antimicrobial agent from entering when the device 10 is mounted to the male connector, as the distal end 58 presses against the inlet port of the male Luer connector. Figures 10-12 As shown, the distal end 58 of the reagent chamber 50 is conical in shape and robustly constructed of an elastomeric material to block fluid paths. The distal end 58 provides a mechanism to block fluid paths in the closed female and male connectors, preventing disinfectants or antimicrobial agents from entering the respective chambers of the female or male connectors. In one or more embodiments, the reagent chamber 50 is insertable into the cavity of a stopcock valve. The outer diameter of the distal end 58 of the reagent chamber 50 is compatible with the outer diameter of an open female Luer connector. The distal end 58 is compressed by the male Luer connector and the closed female Luer connector. Upon compression, the encapsulated disinfectant or antimicrobial agent retreats into the bulb-shaped chamber 60.

[0113] Embodiments of the apparatus disclosed herein enable the sterilization of various connectors. For example... Figure 10As shown, when the device 10 is installed onto a closed female luer on a needleless connector or a hemodialysis connector, the reagent chamber 50 is compressed against the face of the connector or against the surface of a septum embedded in the connector. As shown, Figure 10 This compression causes an increase in pressure within the reagent chamber, resulting in further release of the disinfectant or antiseptic to disinfect the face of the needleless connector and the luer threads. As shown, Figure 11 As shown, when the device 10 is installed onto an open female luer, such as a female luer of a stopcock, the reagent chamber 50, which has a shape similar to a male luer, can be complementarily inserted into the open female luer. As shown, Figure 11 By compressing the bulbous chamber 60, the disinfectant or antiseptic can be released into the internal cavity of the stopcock. As shown, Figure 12 As shown, when the cap is installed onto the male connector, the distal tip of the reagent chamber 50 at the end that blocks the fluid passage contacts the luer port, thereby blocking the port entrance to prevent the disinfectant or antiseptic released subsequently from entering the internal cavity, thus reducing the entry of the disinfectant or antiseptic. As shown, Figure 12 As shown, the compression of the reagent chamber 50 on the male luer connector results in the release of the antiseptic for disinfection.

[0114] When the reagent chamber 50 is deformed or the bulbous chamber 60 is compressed, pressure is applied to the disinfectant or antiseptic, causing the disinfectant or antiseptic to be discharged from the reagent chamber into the area 59 outside the reagent chamber to disinfect the surface of the connector to which the device 10 is attached. The disinfectant or antiseptic can be retained in the space 59 outside the reagent chamber by the O-ring seal 35. The front end of the reagent chamber 50 also has a sealing component, thereby being able to block the fluid passage to avoid the entry of the antiseptic. In one or more embodiments, the device has one open cavity and has a coupling mechanism that automatically fits different types of connectors through simple installation movement. The reagent chamber preloaded with the antiseptic can be deformed to conform to different geometries of different types of connectors. The release of the antiseptic can be controlled by the deformation of the reagent chamber 50 or the compressible bulbous chamber 60. The disinfectant or antiseptic that has been released but retained can disinfect the connector port for a long time.

[0115] The reagent chamber 50 is designed to be compatible with a variety of disinfectants or antimicrobial agents. In one or more embodiments, the disinfectant or antimicrobial agent may include a variant of alcohol or dichlorobenzylguanidine. The disinfectant or antimicrobial agent may be a fluid or gel selected from the group consisting essentially of isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, isopropanol, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, naphthol, chlorhexidine, chlorhexidine acetate, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, dioctylhydrochloride, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, octenidine, octenidine dihydrochloride, antibiotics, and mixtures thereof. The reagent filling chamber 50 contains reagents and is formed by a lower chamber partially surrounded by the connecting cylinder 30, while the upper part of the chamber 50 containing the antimicrobial agent is filled with air. The chamber 50 containing the antimicrobial agent is made of a stretchable material such as an elastomer (e.g., thermoplastic elastomer).

[0116] In one or more embodiments, reagent chamber 50 contains both air and liquid reagents, wherein during insertion of the male or female connector, air pressure on the liquid disinfectant or antimicrobial agent in the reagent chamber is caused by force compression on the bulb-shaped chamber 60 or compression of the elastomeric material of reagent chamber 50, which causes the orifice to open and release the antimicrobial agent.

[0117] In one or more embodiments, the compressible bulb-shaped chamber 60 protrudes above the cap body 20. In one or more embodiments, as... Figures 2-8 As shown, the bulb-shaped chamber is filled with air or gas, and the bulb-shaped chamber 60 is connected to the reagent chamber 50. When the reagent chamber 50 is compressed, the pressure in the bulb-shaped chamber 60 increases, thereby releasing a disinfectant or antibacterial agent from the reagent chamber 50. The degree of pressure increase is determined by the elasticity of the boundary material between the reagent chamber 50 and the bulb-shaped chamber 60. The bulb-shaped chamber 60 also provides additional control by adjusting the pressure within the reagent chamber 50 and the bulb-shaped chamber 60. By manually compressing the bulb-shaped chamber 60, additional disinfectant or antibacterial agent can be released from the reagent chamber 50, thereby sterilizing the connector. In one or more embodiments, the bulb-shaped chamber 60 is made of an elastomeric material. Figures 2-8 As shown, the bulb-shaped chamber 60 may include a thumb pressing portion 61 located at the proximal end of the device, the thumb pressing portion being able to extend along... Figure 11 The direction indicated by the arrow "A" in the image was manually pressed.

[0118] In one or more embodiments, such as Figure 8As shown, the connecting cylinder 30, reagent chamber 50, and bulb-shaped chamber 60 can be mechanically connected and formed as a single unit. In one or more embodiments, the boundaries between the bulb-shaped chamber 60 and the reagent chamber 50 can be joined by ultrasonic welding or adhesive. In an alternative embodiment, the connecting cylinder 30, reagent chamber 50, and bulb-shaped chamber 60 constitute three structurally distinct components.

[0119] Because the deformable connecting sleeve 30 can form a seal on both the male and female Luer connectors, embodiments of the device 10 disclosed herein are adaptable to different types of Luer connectors. The device 10 can also deform the shape of the reagent chamber 50 to accommodate the male connector, the closed female connector, and the open female connector, thereby achieving effective sterilization not only on the outer surface of the Luer but also on the inner cavity of the open female Luer.

[0120] In one or more embodiments, a removable seal is attached to the open end of the cap body to maintain the sterility of the distal end 58, the lumen, and the open distal end.

[0121] like Figure 13 As shown, an alternative embodiment of this disclosure relates to an alternative mechanism for releasing a disinfectant or antibacterial agent. As... Figure 13 As shown, the device 100 includes a cap 120, a connecting tube 130, a bulb-shaped chamber 160, a reagent chamber 150, and a channel 170 connecting the bulb-shaped chamber 160 and the reagent chamber 150. A sidewall 121 has an outer surface 122 and an inner surface 123, an open distal end 124, and a proximal end 125. The proximal end 125 of the cap 120 includes a proximal wall 126 with an orifice 127. In one or more embodiments, the channel is located in the orifice of the proximal wall. In one or more embodiments, the bulb-shaped chamber 160 and the reagent chamber 150 are attached through the orifice 127 located in the proximal wall 126 of the proximal end 125 of the cap 120. The cap 120 also serves as a mechanical barrier to prevent the reagent chamber 150 from being carelessly compressed. The cap body 120 is made of a rigid material, including polypropylene, high-density polyethylene (HDPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, a polyethylene (PE) / thermoplastic elastomer (TPE) blend, or a polypropylene (PP) / polyethylene (PE) material having a thermoplastic elastomer (TPE) coating. In one or more embodiments, a two-stage molding process can be used to manufacture the cap body.

[0122] The sidewall 121 has a length L extending from the proximal end 125 to the open distal end 124. sw Open distal end 124 defined end face.

[0123] The coupling barrel can be made of a semi-rigid material, such as a thermoplastic elastomer (TPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, a polyethylene (PE) / thermoplastic elastomer (TPE) blend, a polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating or other blends of plastic and thermoplastic elastomer, a thermoplastic elastomer (TPE) or rubber with similar elasticity. In one or more embodiments, the coupling barrel can be manufactured using a two-shot molding process.

[0124] The coupling barrel 130 is used to engage the threaded surface of a luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock, and the threaded surface of a collar of a male connector. The coupling barrel 130 is a cylindrical structure with a sidewall 131 having an inner surface 132 that mates with the outer threaded surface of an open or closed female connector or a hemodialysis connector, an outer surface 133 that mates with the threaded surface of a collar on a male connector, an open distal end 134, and a proximal end 136. In one or more embodiments, the female luer connector can be a needleless connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0125] The reagent chamber 150 defines a cavity that contains a disinfectant or an antiseptic. The reagent chamber 150 includes a sidewall 151 having an outer wall surface 152, an inner wall surface 154, an array of resealable apertures 156 integrally populated into the outer wall surface 152 and the inner wall surface 154 of the reagent chamber 150, and a distal terminus 158. A permeable membrane 155 is disposed between the outer wall surface 152 and the inner wall surface 154 of the reagent chamber 150.

[0126] The channel 128 connects the bulbous chamber 160 with the reagent chamber 150. In one or more embodiments, the channel 128 is located in the aperture 127 of the proximal end wall 126.

[0127] The sidewall 151 of the reagent chamber 150 has perforations due to the densely distributed micron- or nanometer-sized apertures 156 that are integrally populated into the outer wall surface 152 and the inner wall surface 154 of the reagent chamber 150. The apertures 156 are covered by a layer of permeable membrane 155 that can form a separate layer attached to the inner wall surface 154 of the reagent chamber, or be embedded as an integral material into the cylindrical sidewall 151. As shown, the combination of the permeable membrane 155 and the apertures 156 enables the dispensing of disinfectant or antiseptic when the pressure within the reagent chamber 150 increases above a threshold value. The permeable membrane 155 adds an additional mechanism for controlling the release rate of the disinfectant or antiseptic, as the threshold pressure can be determined by adjusting the permeability of the permeable membrane material. For example, as shown in FIG. 2, the permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, and the apertures 156 can have a diameter of 0.1 microns. In this example, the threshold pressure is 0.2 atmospheres. When the pressure within the reagent chamber 150 increases above 0.2 atmospheres, the apertures 156 will open and the disinfectant or antiseptic will be released. The permeable membrane 155 can be a microporous membrane, a nanomembrane, or a combination of microporous and nanomembrane. The permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, a nanomembrane with a pore size of 0.02 microns, or a combination of a microporous membrane with a pore size of 0.2 microns and a nanomembrane with a pore size of 0.02 microns. In one or more embodiments, the permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, a nanomembrane with a pore size of 0.02 microns, or a combination of a microporous membrane with a pore size of 0.2 microns and a nanomembrane with a pore size of 0.02 microns. Figures 14-19 The combination of the permeable membrane 155 and the apertures 156 enables the dispensing of disinfectant or antiseptic when the pressure within the reagent chamber 150 increases above a threshold value. The permeable membrane 155 adds an additional mechanism for controlling the release rate of the disinfectant or antiseptic, as the threshold pressure can be determined by adjusting the permeability of the permeable membrane material. For example, as shown in FIG. 2, the permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, and the apertures 156 can have a diameter of 0.1 microns. In this example, the threshold pressure is 0.2 atmospheres. When the pressure within the reagent chamber 150 increases above 0.2 atmospheres, the apertures 156 will open and the disinfectant or antiseptic will be released. The permeable membrane 155 can be a microporous membrane, a nanomembrane, or a combination of microporous and nanomembrane. The permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, a nanomembrane with a pore size of 0.02 microns, or a combination of a microporous membrane with a pore size of 0.2 microns and a nanomembrane with a pore size of 0.02 microns. In one or more embodiments, the permeable membrane 155 can be a microporous membrane with a pore size of 0.2 microns, a nanomembrane with a pore size of 0.02 microns, or a combination of a microporous membrane with a pore size of 0.2 microns and a nanomembrane with a pore size of 0.02 microns.Figures 17-19 As shown, the threshold can be adjusted high enough so that the antimicrobial agent is not activated until the bulbous chamber is manually compressed.

[0128] The permeable membrane 155 is composed of a material with holes that are not completely removed so that when pressure is applied the holes 156 open. The holes 156 are micron holes covered by a layer of permeable membrane 155 with very small scale creases from which liquid disinfectant or antimicrobial agent can seep. In one or more embodiments, the micron holes of the holes 156 are 100 microns in size. In one or more embodiments, the micron holes of the holes 156 are 100 nanometers in size. In one or more embodiments, the holes in the holes 156 remain open after pressure removal, creating an actual channel and cannot reseal. In one or more embodiments, the holes are covered with a fibrous web or filter material. In one or more embodiments, when the permeable membrane is applied with pressure, the liquid permeates without pressure and the permeable membrane forms a barrier because the small hole membrane is covered with a fibrous web or filter material.

[0129] The boundary material of the reagent chamber 150 has a large number of micron or nanometer sized holes 156 embedded in the polymer matrix. The permeable membrane 155 is either attached to the reagent chamber boundary as a separate layer or embedded in the boundary material to act as a barrier to prevent leakage of the encapsulated liquid. In one or more embodiments, as shown, Figure 15 As shown, the permeable membrane has smaller holes than the holes of the reagent chamber material. In one or more embodiments, the permeable membrane 155 is adhered to the reagent chamber 150. The permeable membrane 155 has smaller sized holes 156 (nanopores) or a layer of thinner permeable water-deposited material.

[0130] In one or more embodiments, the compressible bulbous chamber 160 protrudes above the cap 120. In one or more embodiments, as shown, Figure 13 As shown, the bulbous chamber is filled with air or gas and the bulbous chamber 160 is connected to the reagent chamber 150. When the reagent chamber 150 is compressed, the pressure in the bulbous chamber 160 increases, releasing disinfectant or antimicrobial agent from the reagent chamber 150. The degree of pressure increase depends on the elasticity of the boundary material of the reagent chamber 150 and the bulbous chamber 160 and the permeable membrane. The bulbous chamber 160 also provides for additional control by adjusting the pressure within the reagent chamber 150 and the bulbous chamber 160. By manually compressing the bulbous chamber 160, additional disinfectant or antimicrobial agent can be released from the reagent chamber 150, disinfecting the connector. In one or more embodiments, the bulbous chamber 160 is made of an elastomeric material. As shown, Figure 13 As shown, the bulbous chamber 160 can include a thumb press 161 at the proximal end of the device that can be pressed along Figures 17-19The direction indicated by arrow "A" in the middle is pressed manually.

[0131] The reagent chamber 150 is activated by compressing the bulb chamber 160 protruding above the cap 120. In one or more embodiments, the bulb chamber 160 is filled with air. When the bulb chamber 160 is squeezed, the pressure is raised by compressing the air to force the liquid disinfectant or antiseptic in the reagent chamber 150 through the permeable membrane 155 to be released.

[0132] The reagent chamber 150 can be inserted into the inner lumen of a stopcock. Its outer diameter is compatible with the outer diameter of an open female luer. It is compressed by a male luer and a closed female luer. Figures 17-18 A device is shown connected to a female luer connector according to the prior art. Figure 13 A device is shown connected to a female luer connector according to the prior art. Figure 19 A device is shown connected to a male luer connector according to the prior art. Figure 13 A plan view of the device is shown. After compression, the enclosed fluid is withdrawn into the bulb chamber 160.

[0133] The reagent chamber 150 is designed to be compatible when interacting with various disinfectants or antiseptics. In one or more embodiments, the disinfectant or antiseptic can include alcohol or a variant of chlorhexidine. The disinfectant or antiseptic can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, isopropyl alcohol, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzalkonium chloride, octenidine, octenidine dihydrochloride, antibiotics, and mixtures thereof. The reagent fills the chamber 150 containing the reagent, which constitutes the lower chamber partially surrounded by the coupling barrel 130, while the upper portion of the chamber 150 containing the antiseptic is filled with air. In one or more embodiments, the chamber 150 containing the antiseptic is composed of a stretchable material such as an elastomer (e.g., a thermoplastic elastomer).

[0134] The coupling barrel 130 is a cylindrical structure with an opening at the bottom. The inner surface matches the outer threaded surface of the open or closed female connector and the hemodialysis connector. The outer surface matches the threaded surface of the collar on the male connector.

[0135] In one or more embodiments, one or more leaf springs 140 are integrated into the sidewall 131 of the coupling barrel 130 to provide mechanical strength to maintain the original form of the sealed coupling barrel 30 and overcome the deformation forces exerted by the connector when the coupling barrel 130 is installed onto the male or female connector. The leaf springs 140 can be embedded in the material of the sidewall 131 of the coupling barrel 130, embedded in a groove of the material of the sidewall 131 of the coupling barrel 130, or inserted into the sidewall 131 of the coupling barrel 130 during the molding process or attached by adhesive. The leaf springs 140 can be made of a rigid but deformable material including thin sheets of stainless steel or metal alloys. The leaf springs 140 can take the form of a rectangle with a high geometric aspect ratio. An array of 4 to 6 leaf springs 140 can be embedded into the wall of the coupling barrel 130 with equal angular dispersion, and the array can be axially symmetric around the central axis of the coupling barrel 130.

[0136] The O-ring structure 135 at the open distal end 134 of the coupling barrel 130 is capable of sealing against liquid disinfectants or antiseptics to prevent leakage of the disinfectants or antiseptics when the device 100 is installed onto the connector. In one or more embodiments, the O-ring 135 is integrated at the open distal end of the coupling barrel 130 for a tight grip on the surface of the connector. At the open end of the open cavity, the edge of the cylindrical coupling device forms the O-ring 135 to enhance the grip tightness of the joint between the coupling barrel 130 and the surface of the connector. The O-ring 135 also serves to form a seal for the purpose of creating a closed space between the connector and the coupling barrel 130. The O-ring structure 135 at the open distal end 134 of the coupling barrel 130 is capable of sealing against any liquid reagent that is to exit the reagent chamber to prevent leakage of the reagent when the device 100 is installed onto the connector. In one or more embodiments, the O-ring 135 is made of an elastic material that is flexible and maintains its original shape in the initial state. Upon insertion of the connector with the coupling barrel 130, the O-ring 135 expands to accommodate the connector, thereby forming a tight seal around the connector. Upon removal of the connector, the O-ring 135 reverts to its initial state.

[0137] In one or more embodiments, the open distal end 124 of the cap 120 is at approximately the same horizontal plane P as the distal end 158 of the reagent chamber 150 in the initial state, such that when a female or male luer connector is engaged to the device 100, the reagent chamber 150 is compressed and the reagent chamber 150 retracts towards the proximal wall 126. The distal end 158 serves as a fluid path blocking device, thereby blocking the entry of antiseptics when the distal end is pressed against the entry port of the male luer connector when the device 100 is installed onto the male connector. As Figures 17-19As shown, the distal tip 158 of the reagent chamber 150 is conically shaped and is firmly constructed of an elastomeric material for blocking the fluid path. The distal tip 158 provides a mechanism to block the fluid path in the closed female and male connectors to prevent the disinfectant or antiseptic from entering the chamber of the respective female or male connector. In one or more embodiments, the reagent chamber 150 can be inserted into the inner lumen of the stopcock valve. The outer diameter of the distal tip 158 of the reagent chamber 50 can be compatible with the outer diameter of the open female luer connector. The distal tip 158 is compressed by the male luer connector and the closed female luer connector. Upon compression, the encapsulated disinfectant or antiseptic is retracted into the bulb chamber 160.

[0138] Upon installation of the device 100 onto the male or female connector, the distal tip 158 is pressed against the entry port of the male or female luer connector to block the entry of disinfectant or antiseptic.

[0139] In one or more embodiments, the bulb chamber 160 and the reagent chamber 150 are attached through an aperture 127 in the proximal end wall 126 of the proximal end 125 of the cap 120. The cap 120 also serves as a mechanical barrier to prevent the reagent chamber 150 from being compressed by accident. The cap 120 is constructed of a rigid material including polypropylene, high-density polyethylene (HDPE), polypropylene (PP) / thermoplastic elastomer (TPE) blend, polyethylene (PE) / thermoplastic elastomer (TPE) blend, or polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating. In one or more embodiments, the cap can be manufactured using a two-shot molding process.

[0140] In one or more embodiments, as Figure 13 shown, the coupling barrel 130, the reagent chamber 150, and the bulb chamber 160 can be mechanically connected and can be formed as one piece. In one or more embodiments, the boundary of the bulb chamber 160 and the reagent chamber 150 can be joined by ultrasonic welding or adhesive. In an alternative embodiment, the coupling barrel 130, the reagent chamber 150, and the bulb chamber 160 constitute three structurally distinct components.

[0141] In one or more embodiments, the device can also include a removable or peelable seal on the open distal end 124 of the cap 120 to maintain the sterility of the distal tip 158, the inner lumen, and the open distal end. In one or more embodiments, the removable or peelable seal can include a peel top made of aluminum or a multi-layer polymer film.

[0142] As shown in FIGS. 20a-20e, one alternative embodiment of the present disclosure relates to an alternative mechanism for reinforcing the sidewall of the coupling barrel. As shown in FIGS. 20a-20b, the device 200 includes a cap 220, a coupling barrel 230, a bulbous chamber 260, a reagent chamber 250, and a channel 270 connecting the bulbous chamber 260 to the reagent chamber 250. The sidewall 221 has an outer surface 222 and an inner surface 223, an open distal end 224, and a proximal end 225. The proximal end 225 of the cap 220 includes a proximal end wall 226 having an aperture 227. In one or more embodiments, the channel is located in the aperture of the proximal end wall. In one or more embodiments, the bulbous chamber 260 and the reagent chamber 250 are attached through the aperture 227 in the proximal end wall 226 of the proximal end 225 of the cap 220. The cap 220 also serves as a mechanical barrier to prevent the reagent chamber 250 from being compressed by accident. The cap 220 is constructed of a rigid material including polypropylene, high-density polyethylene (HDPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, a polyethylene (PE) / thermoplastic elastomer (TPE) blend, or a polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating. In one or more embodiments, the cap can be manufactured using a two-shot molding process.

[0143] The coupling barrel can be made of a semi-rigid material such as a thermoplastic elastomer (TPE), a polypropylene (PP) / thermoplastic elastomer (TPE) blend, a polyethylene (PE) / thermoplastic elastomer (TPE) blend, a polypropylene (PP) / polyethylene (PE) material with a layer of thermoplastic elastomer (TPE) coating or other mixtures of plastic and thermoplastic elastomer, a thermoplastic elastomer (TPE) or rubber with similar elasticity. In one or more embodiments, the coupling barrel can be manufactured using a two-shot molding process.

[0144] The coupling barrel 230 is used to engage the threaded surface of a luer connector, including the threaded surface of a needleless connector, the threaded surface of an open female luer of a stopcock valve, and the threaded surface of the collar of a male connector. As shown in FIGS. 20a and 20b, the coupling barrel 230 is composed of a cylindrical thin wall of a sheet metal 242 as shown in FIG. 20c, a sheet metal 242 with perforations as shown in FIG. 20d, or a sheet metal 242 with mesh as shown in FIG. 20e, thereby providing a reinforcing component to the sidewall of the coupling barrel 230. This thin wall reinforcing structure provides mechanical strength to the coupling barrel 230 to maintain the geometric integrity of the coupling barrel 230, while it does not completely compromise the flexibility of the coupling barrel 230, so the coupling barrel 230 is still able to bend to conform to the shape of the connector on which the device 200 is installed.

[0145] The reagent chamber 250 defines a cavity that contains a disinfectant or antiseptic agent. The reagent chamber 250 includes a sidewall 251 having an outer wall surface 252, an inner wall surface 254, an array of resealable apertures 256 densely integrated into the outer wall surface 252 and the inner wall surface 254 of the reagent chamber 250, and a distal terminus 258. In one or more embodiments, a permeable membrane 255 is disposed between the outer wall surface 252 and the inner wall surface 254 of the reagent chamber 250. The permeable membrane 255 is either attached to the reagent chamber boundary as a separate layer or is embedded into the boundary material to serve as a barrier to prevent leakage of the encapsulated liquid. In one or more embodiments, the permeable membrane has smaller pores than the pores of the reagent chamber material.

[0146] The channel 228 connects the bulbous chamber 260 with the reagent chamber 250. In one or more embodiments, the channel 228 is located in the orifice 227 of the proximal wall 226.

[0147] The sidewall 251 of the reagent chamber 250 has perforations due to the densely distributed micron- or nanometer-sized apertures 256 densely integrated into the outer wall surface 252 and the inner wall surface 254 of the reagent chamber 250.

[0148] In one or more embodiments, the reagent chamber 250 can be activated by compressing the bulbous chamber 260 protruding above the cap 220. When the bulbous chamber 260 is squeezed, force is applied to the reagent in the reagent chamber 250 by the rising pressure caused by the compressed air, releasing the reagent through the sidewall 251 of the reagent chamber 250.

[0149] The reagent chamber 250 can be inserted into the lumen of a stopcock valve. Its outer diameter is compatible with the outer diameter of an open female luer. The reagent chamber is compressed by a male luer and a closed female luer. Upon compression, the encapsulated fluid is withdrawn into the bulbous chamber 260.

[0150] The reagent chamber 250 is designed to be compatible when interacting with various disinfectants or antiseptics. In one or more embodiments, the disinfectant or antiseptic can include alcohol or a variant of chlorhexidine. The disinfectant or antiseptic can be a fluid or gel selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, isopropyl alcohol, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, octenidine dihydrochloride, antibiotics, and mixtures thereof. The reagent fills the chamber 250 containing the reagent, which constitutes the lower chamber partially surrounded by the coupling barrel 230, while the upper portion of the chamber 250 containing the antiseptic is filled with air. In one or more embodiments, the chamber 250 containing the antiseptic is composed of a stretchable material such as an elastomer (e.g., a thermoplastic elastomer).

[0151] The coupling barrel 230 is a cylindrical structure with an opening at the bottom. The inner surface matches the outer threaded surface of the female connector and the hemodialysis connector, whether open or closed. The outer surface matches the threaded surface of the collar on the male connector.

[0152] The O-ring structure 235 at the open distal end 234 of the coupling barrel 230 is capable of sealing against the liquid disinfectant or antiseptic to prevent leakage of the disinfectant or antiseptic when the device 200 is installed onto the connector. In one or more embodiments, the O-ring 235 is integrated at the open distal end of the coupling barrel 230 for a tight grip on the surface of the connector. At the open end of the open cavity, the edge of the cylindrical coupling device forms the O-ring 235 to enhance the grip tightness of the joint between the coupling barrel 230 and the connector surface. The O-ring 235 also serves the purpose of forming a seal to create a closed space between the connector and the coupling barrel 230. The O-ring structure 235 at the open distal end 234 of the coupling barrel 230 is capable of sealing against any liquid reagent that is to exit the reagent chamber to prevent leakage of the reagent when the device 200 is installed onto the connector. In one or more embodiments, the O-ring 235 is made of an elastic material that is flexible and maintains its original shape in the initial state. Upon insertion of the coupling barrel 230 into the connector, the O-ring 235 expands to accommodate the connector, thereby forming a tight seal around the connector. Upon removal of the connector, the O-ring 235 returns to its initial state.

[0153] In one or more embodiments, the open distal end 224 of the cap 220 is in the initial state at approximately the same horizontal plane P as the distal tip 258 of the reagent chamber 250, such that when the female or male luer connector is engaged to the device 200, the reagent chamber 250 is compressed and the reagent chamber 250 retracts towards the proximal wall 226. The distal tip 258 acts as a fluid path barrier such that when the device 200 is installed onto the male connector, the entry of antiseptic is blocked when the distal tip is pressed against the entry port of the male luer connector. The distal tip 258 of the reagent chamber 250 is conically shaped and is solidly constructed of elastomeric material for blocking the fluid path. The distal tip 258 provides a mechanism to block the fluid path in the closed female and male connectors to prevent the entry of the disinfectant or antiseptic into the chamber of the respective female or male connector. In one or more embodiments, the reagent chamber 250 can be inserted into the inner lumen of the stopcock valve. The outer diameter of the distal tip 258 of the reagent chamber 50 can be compatible with the outer diameter of the open female luer connector. The distal tip 258 is compressed by the male luer connector and the closed female luer connector. Upon compression, the encapsulated disinfectant or antiseptic retracts into the bulb chamber 260.

[0154] Upon installation of the device 200 onto the male or female connector, the distal tip 258 is pressed against the entry port of the male or female luer connector to block the entry of disinfectant or antiseptic.

[0155] In one or more embodiments, the coupling barrel 230, the reagent chamber 250 and the bulb chamber 260 can be mechanically connected and can be formed as one piece as shown in Figures 20a and 20b. In one or more embodiments, the boundary of the bulb chamber 260 and the reagent chamber 250 can be joined by ultrasonic welding or adhesive. In an alternative embodiment, the coupling barrel 230, the reagent chamber 250 and the bulb chamber 260 constitute three structurally distinct components.

[0156] In one or more embodiments, the device can further include a removable or peelable seal on the open distal end 224 of the cap 220 to maintain the sterility of the distal tip 258, the inner lumen and the open distal end. In one or more embodiments, the removable or peelable seal can include a peel top made of aluminum or a multi-layer polymer film.

[0157] Embodiments of the devices 10, 200, and 200 of the present disclosure take advantage of the adaptability of the elastomeric material and the compressibility of the space enclosed by the elastomeric material. The design is based on the use of elastomeric material to form components suitable for the needs of a disinfecting cap that can accommodate different types of luer connectors and that can release an antimicrobial material for disinfection in a manner compatible with the cleaning needs of different types of luer connectors. Embodiments of the present disclosure also combine a compliant material with a rigid material to form a deformable composite material that conforms to various geometries but still maintains structural strength to meet the needs of fitting onto a connector on one hand and sealing a disinfecting space on the other, thereby achieving both prevention of leakage of the antimicrobial agent and forming a mechanical barrier to reduce contamination.

[0158] In one or more embodiments, the devices 10, 100, and 200 of the present disclosure can be manufactured according to injection molding or blow-fill-seal techniques well known to those skilled in the art.

[0159] The concept of the blow-fill-seal process is that, in a sterile enclosed area inside the machine, containers are shaped, filled, and sealed as an integrated container in a continuous manner without human intervention. Blow-fill-seal manufacturing is the formation of a closed container by extrusion and shaping of a parison within a mold, filling of the container, and sealing of the container in a single step. This manufacturing process makes it possible to produce the devices in a single process. For example, a pharmaceutical grade resin is extruded into a tube, which is then formed into a bulbous chamber and a reagent chamber. A mandrel is inserted into the newly formed bulbous chamber and reagent chamber and filled. The bulbous chamber and reagent chamber are then sealed and joined together with a cap, such that they are both within a sterile, overmolded cavity. The device is then ejected to a non-sterile area for packaging and distribution. This blow-fill-seal technique includes continuous extrusion through an extruder head with a section of parison in the form of a hollow tube between and through two cooperating first or main mold halves. The method includes the steps of cutting the parison below the extruder head and above the main mold halves to form an opening that enables a blow and fill nozzle assembly to be moved downwardly into the opening in the parison for molding, and subsequently filling the molded bulbous chamber and reagent chamber. The blow and fill nozzle assembly is retracted from the opening in the parison when the container portion of the container assembly is filled with the desired amount of liquid disinfectant or antimicrobial agent. A separate pair of cooperating second or upper sealing mold halves is then moved together around the exposed section of the parison to shape and seal the bulbous chamber upper portion. The assembled finished product, which is a fully shaped, filled, and sealed integrated structure, is then ejected from the molding apparatus.

[0160] Embodiments of the present disclosure can be used with access ports including needle-free connectors, male luer connectors on intravenous tubing / extension tubing, open female luer on stopcock, and hemodialysis connectors for disinfection purposes. In some embodiments, the connector includes a needle-free injection site, which can sometimes be referred to as a needle-free injection port, access hub, valve, or device, or as a needle-free access site, port, access hub, valve, or device. In one or more embodiments, the female connector can be a needle-free connector, a stopcock, or a hemodialysis connector. In one or more embodiments, the needle-free connector is selected from the group consisting of 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, and the like. In one or more embodiments, the male connector can be an intravenous tubing end or a stopcock.

[0161] In some embodiments, the devices 10, 100, and 200 of the present disclosure can be connected with any of a variety of different needle-free injection sites such as those listed above. By using the devices 10, 100, and 200 of the present disclosure, the standard swabbing protocol for cleaning the connector is replaced.

[0162] "one or more embodiments," or "an embodiment," that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrase "in one or more embodiments," "in certain embodiments," "in one embodiment," or "in an embodiment" in various places in the specification are not necessarily referring to the same embodiment. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments.

[0163] While the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will thus be apparent that modifications and variations can be made in the method and apparatus of the present disclosure, in the spirit and scope of the disclosure, without departing from the spirit and scope of the disclosure. It is therefore requested that the present disclosure be interpreted not as being limited to the described embodiments, but rather that it be interpreted broadly to include all the features and benefits summarised above, as well as those inherent to the technology.

Claims

1. A device for connecting to a medical connector, the device comprising: A cap body, the cap body including a sidewall having an outer surface and an inner surface, an open distal end, and a proximal end including a proximal end wall having an opening; A connecting cylinder located within the cap body, the connecting cylinder having a distal end and deformable sidewalls, the connecting cylinder being capable of mating with a male connector or a female connector; A bulb-shaped chamber, located on the proximal wall of the cap body, the bulb-shaped chamber being compressible and filled with air; The reagent chamber located within the connecting cylinder defines a compressible chamber for containing a disinfectant or antibacterial agent. The reagent chamber has an outer wall surface, an inner wall surface, an array of resealable holes densely integrated into the outer and inner wall surfaces of the reagent chamber, a permeable membrane disposed between the outer and inner wall surfaces of the reagent chamber, and a conical distal end firmly constructed of an elastomeric material. and The channel connecting the bulb-shaped chamber to the reagent chamber is located in the orifice of the proximal end wall.

2. The apparatus according to claim 1, wherein, The distal end of the connecting cylinder has an O-ring.

3. The apparatus according to claim 2, wherein, The O-ring is made of an elastomeric material.

4. The apparatus according to claim 1, wherein, The deformable sidewall has one or more leaf springs that are longitudinally embedded within the deformable sidewall.

5. The apparatus according to claim 4, wherein, The one or more leaf springs are in the form of a rectangle with a high aspect ratio.

6. The apparatus according to claim 4, wherein, The one or more leaf springs are embedded in the side wall of the connecting cylinder at equal angles.

7. The apparatus according to claim 4, wherein, The one or more leaf springs are axially symmetrical about the central axis of the connecting cylinder.

8. The apparatus according to claim 4, wherein, The one or more leaf springs are made of thin sheets of stainless steel or metal alloy.

9. The apparatus according to claim 1, wherein, The open distal end of the cap is initially located on a horizontal plane P that is substantially the same as the distal conical end of the reagent chamber.

10. The apparatus according to claim 1, wherein, When the female or male Luer connector is engaged with the device, the reagent chamber is compressed and retracts toward the proximal wall.

11. The apparatus according to claim 10, wherein, The disinfectant or antibacterial agent is released from the reagent chamber by compressing the reagent chamber to disinfect the female Luer connector or the male Luer connector.

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

13. The apparatus according to claim 1, wherein, The disinfectant or antibacterial agent is a fluid or gel.

14. The apparatus according to claim 1, wherein, The female connector is selected from the group consisting essentially of needleless connectors, stopcock valves, and hemodialysis connectors.

15. The apparatus according to claim 1, wherein, The male connector is the end of an intravenous tubing or a stopcock valve.

16. The device of claim 1, further comprising a peelable seal on the open distal end of the cap body.

17. The apparatus according to claim 1, wherein, The permeable membrane is perforated by an array of densely distributed, automatically resealing pores integrated into the outer and inner wall surfaces of the reagent chamber.

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