Universal cap for male / female connectors

Abstract

An apparatus for connecting to a medical connector includes a cap, a resilient sealing ring, a locking lid, and a peelable seal. The cap is configured to define a chamber containing an absorbent material and a disinfectant or antibacterial agent. The cap can include one or more threads adapted to engage with a female Luer connector. The cap is adapted to engage with a male Luer connector in a press-fit connection. The peelable seal prevents the disinfectant or antibacterial agent from escaping from the chamber. Also described are a method of disinfecting a medical connector and an assembly including the apparatus for disinfecting a medical connector.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates generally to devices for disinfecting and sterilizing access ports, for example, with male and female luer fittings, and in particular to disinfection and sterilization devices that can accommodate multiple types of connectors. [Background technology]

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system through the access hub and ports / valves upon connection to a VAD for fluid or medication delivery. Each access hub (or port / valve or connection) is associated with a risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

[0003] Codes of practice, including disinfection and cleaning procedures, have been developed to reduce cases of CRBSI and ensure VADs are used and maintained correctly.

[0004] Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and there are early indications that the caps will also be incorporated into the 2016 Infusion Nursing Standards (INS) guidelines.

[0005] In developed markets, when using IV catheters, needleless connectors are typically used to seal the system and then access it to administer medications and other necessary fluids to the patient via the catheter. The INS Standards of Practice recommend the use of needleless connectors and state that they should be consistently and thoroughly disinfected before each access using alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination. Disinfection of needleless connectors ultimately aims to help reduce bacteria that inhabit surfaces and can cause various catheter-related complications, including CRBSI. Nurses typically complete this disinfection process using a 70% isopropyl alcohol (IPA) pad in a process known as "hub scrubbing." However, adherence to this practice is generally very low. In addition to a lack of compliance with "hub scrubbing," clinician interviews also noted frequent variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0006] There are many risks of contact or contamination throughout the sequence of steps associated with the transmission of microorganisms that can cause CRBSI. Contamination can occur during drug mixing, cannulation, and insertion into the access hub. Because the procedure of connecting a VAD is so common and simple, the risks associated with entering the patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.

[0007] Currently, caps for male needleless connectors, caps for female needleless connectors, intravenous (IV) caps, and caps for hemodialysis lines differ in design, limiting the type of connector they can be attached to. Therefore, conventional disinfection caps are designed to fit only one type of connector and are specific to one particular size and / or shape of connector. Therefore, to streamline the disinfection process, a disinfection device that can accommodate multiple types of connectors is needed. There is also a need for a disinfection device that can disinfect for multiple days. Summary of the Invention

[0008] One aspect of the present disclosure relates to a device for connecting to a medical connector. According to an exemplary embodiment of the present disclosure, the device generally includes a cap, an absorbent material, a disinfectant or antibacterial agent, a resilient sealing ring, a locking lid, and a peelable seal. The cap includes an integral body, a closed end, and an annular wall having a length extending from the closed end to an open end, the annular wall defining a chamber containing the absorbent material and the disinfectant or antibacterial agent. The open end includes a peripheral ledge defining an end face and extending radially inward from the annular wall. The open end defines an engagement surface.

[0009] The annular wall of the cap includes an outer wall surface and an inner wall surface, the inner wall surface defining an opening adjacent the open end.

[0010] The resilient sealing ring includes an expandable opening sized to receive a male luer connector, a female luer connector, or a hemodialysis connector. The expandable opening can be sized to frictionally engage the male luer connector. In one or more embodiments, the expandable opening has an expandable diameter from an initial diameter of about 7-9 mm to an expanded diameter of about 9-12 mm. In one or more embodiments, a peripheral ledge is sized to receive the resilient sealing ring. In one or more embodiments, the resilient sealing ring is in contact with the peripheral ledge. In one or more embodiments, when the male luer connector is inserted into the chamber through the expandable opening in the resilient sealing ring, it frictionally engages the expandable opening via a press-fit connection.

[0011] In one or more embodiments, the peripheral ledge is sized to receive a resilient seal ring.

[0012] In one or more embodiments, the inner wall surface includes internal threads adjacent the closed end. The internal threads are sized to engage with a female luer connector. In one or more embodiments, the internal threads extend partially along the length of the inner wall surface of the cap adjacent the closed end of the cap.

[0013] The absorbent material and disinfectant or antimicrobial agent contact the male luer connector, female luer connector, and hemodialysis connector after they are inserted through the expandable opening in the elastomeric sealing ring.

[0014] The locking lid engages the engagement surface to secure the resilient sealing ring to the open end. The locking lid includes an end face.

[0015] A peelable seal can be placed on the end face or cap of the locking lid to prevent the disinfectant or antimicrobial agent from leaving the chamber.

[0016] In one or more embodiments, the female luer connector is selected from the group consisting essentially of a needleless connector, a stopcock, and a hemodialysis connector.

[0017] In one or more embodiments, the male connector is an intravenous tubing end or a stopcock.

[0018] The resilient sealing ring comprises an elastomeric material.

[0019] In one or more embodiments, the elastomeric material of the resilient sealing ring comprises a thermoplastic elastomer.

[0020] The cap and locking lid can be made from any of a number of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the cap and locking lid comprise a polypropylene or polyethylene material. In one or more embodiments, the outer cap surface includes a plurality of gripping members.

[0021] In one or more embodiments, the absorbent material has slits. In one or more embodiments, the absorbent material is radially compressed by the internal threads to retain the absorbent material within the chamber. In one or more embodiments, the absorbent material is retained within the chamber without radial compression by the internal threads. In one or more embodiments, the absorbent material is a nonwoven material, a foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam.

[0022] In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antibacterial agent is a fluid or gel.

[0023] Upon connection to the female or male luer connector, the absorbent material is compressed towards the closed end of the chamber, allowing the connector to come into contact with a disinfectant or antimicrobial agent, thereby disinfecting the female or male luer connector.

[0024] In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel back top. In certain embodiments, the peelable seal is heat or induction sealed to the edge of the locking lid.

[0025] A second aspect of the present disclosure relates to a method of disinfecting a medical connector, the method comprising connecting an apparatus of one or more embodiments to the medical connector, the connecting step comprising engaging an inner wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

[0026] A third aspect of the present disclosure relates to an assembly comprising the device of one or more embodiments connected to a medical connector, in one or more embodiments, the medical connector being selected from a male luer connector, a female luer connector, and a needleless connector. [Brief explanation of the drawings]

[0027] [Figure 1] 1 shows a perspective view of one embodiment of an apparatus of the present disclosure. [Figure 2] 1 shows a perspective elevation view of a device according to one embodiment of the present disclosure. [Figure 3] 3 shows a partial cross-sectional view of components of an apparatus according to one embodiment of the present disclosure taken along line 3-3 of FIG. 1. [Figure 4] FIG. 2 shows a bottom view of the components of the device of FIG. 1. [Figure 5] 2 illustrates a perspective view of an exemplary resilient seal ring of the device of FIG. 1. [Figure 6] 2 shows a perspective view of an exemplary peelable seal of the device of FIG. 1. [Figure 7] 2 illustrates a perspective view of an exemplary locking ring of the device of FIG. 1. [Figure 8] 2 illustrates a bottom perspective view of an exemplary locking ring of the device of FIG. 1. [Figure 9] 2 shows a top view of an exemplary absorbent material of the device of FIG. 1. [Figure 10] 2 shows a perspective view of an exemplary absorbent material of the device of FIG. 1. [Figure 11] 1 shows a perspective view of a female luer connector with a septum according to the prior art. [Figure 12] 1 shows a perspective view of a female luer connector with a stopcock according to the prior art. [Figure 13] 1 shows a perspective view of a male luer connector according to the prior art. [Figure 14] 1 is a perspective view of a hemodialysis connector according to the prior art. DETAILED DESCRIPTION OF THE INVENTION

[0028] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description, as the present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0029] Embodiments of the present disclosure relate to a sterile, universal single-use device for connecting to and disinfecting medical connectors, including male and female Luer connectors. The device includes a cap, an elastomeric sealing ring, an absorbent material, a disinfectant or antibacterial agent, and a peelable seal. The device provides a mechanical barrier to the connector and contains an antibacterial agent for disinfection. The device of the present disclosure allows practitioners to streamline the disinfection process.

[0030] The following definitions are provided for terms used in this disclosure.

[0031] As used herein, the use of "a," "an," and "the" includes the singular and the plural.

[0032] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line.

[0033] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing and are slightly tapered, allowing for a more secure connection even with a natural pressure / twist fit. Luer connectors can optionally include an additional outer rim of threads to further securely secure the Luer connector. The male end of a Luer connector is typically associated with a flush syringe and can be interlocked with and connected to a female end located on a vascular access device (VAD). Luer connectors have a distal end, a proximal end, an irregularly shaped outer wall, and a contoured central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Luer connectors also have a distal end channel that detachably attaches the Luer connector to the hub of the VAD and a proximal end channel that detachably attaches the Luer connector to the syringe barrel.

[0034] The assembled device is shown in Figures 1-3, with the components shown separately in Figures 4-10. Figures 11-14 illustrate various connectors according to the prior art. With reference to Figures 1-3, an apparatus 100 for connecting to a medical connector according to an exemplary embodiment of the present disclosure generally includes a cap 102, an absorbent material 114, a disinfectant or antimicrobial agent, a resilient sealing ring 126, a locking lid 130, and a peelable seal 150. With reference to Figure 4, the cap 102 has a unitary body 104, a closed end 106, a length L extending from the closed end 106 to an open end 110, and a removable seal 150. C and includes an annular wall 108 defining a chamber 112 containing an absorbent material 114 and a disinfectant or antimicrobial agent. The open end 110 defines an end face 118 and includes a peripheral ledge 116 extending radially inward from the annular wall 108. The open end 110 also defines an engagement surface 120.

[0035] 3 and 4, the annular wall 108 of the cap 102 includes an outer wall surface 122 and an inner wall surface 124. The inner wall surface 124 defines an opening 138 adjacent the open end 110.

[0036] Referring to FIG. 3, in one or more embodiments, a resilient seal ring 126 contacts the peripheral ledge 116 .

[0037] Referring to FIG. 5 , the resilient sealing ring 126 includes an expandable opening 128 therethrough that is sized to receive a male luer connector, a female luer connector, and a hemodialysis connector. The expandable opening 128 can be sized to frictionally engage the male luer connector. In one or more embodiments, the expandable opening 128 has an expandable diameter from an initial diameter in the range of approximately 7-9 mm to an expanded diameter in the range of approximately 9-12 mm. In one or more embodiments, when the male luer connector is inserted into the chamber 112 through the expandable opening 128 of the resilient sealing ring 126, it frictionally engages the expandable opening 128 via a press-fit connection. In one or more embodiments, the resilient sealing ring 126 is in the form of an O-ring.

[0038] In this way, use of device 100 requires only a single application action by the user. Use of device 100 does not activate the fluid pathway of a female Luer connector with a septum or a hemodialysis connector with a sheath.

[0039] 3, in one or more embodiments, the resilient sealing ring 126 contacts the peripheral ledge 116. With reference to FIGS. 3 and 4, in one or more embodiments, an opening 138 adjacent the open end 110 of the inner wall surface 124 is sized to receive the resilient sealing ring 126 in a press-fit connection.

[0040] In one or more embodiments, the inner wall surface 124 includes internal threads adjacent the closed end 106. The internal threads are sized to engage a female luer connector. In one or more embodiments, the internal threads adjacent the closed end 106 of the cap 102 extend partially along the length of the inner wall surface 124 of the cap 102.

[0041] The absorbent material 114 and disinfectant or antimicrobial agent contact the male luer connector 200 , female luer connector 300 , and hemodialysis connector 400 after they are inserted through the expandable opening 128 in the elastic sealing ring 126 .

[0042] 1 and 7-8, locking lid 130 engages mating surface 120 of cap 102 to secure resilient sealing ring 126 to open end 110 of cap 102. Locking lid 130 has an end surface 132 to which peelable seal 150 may be secured.

[0043] 1-3 and 6 , in one or more embodiments, a peelable seal 150 is disposed on the end surface 132 of the locking lid 130 to prevent the disinfectant or antimicrobial agent from escaping the chamber 112. When the absorbent material 114 is properly inserted into the chamber 112 of the cap 102, the peelable seal 150 may be secured to the end surface 132 of the locking lid 130, sealing the device 100. The peelable seal 150 minimizes the ingress of potential particulate hazards and provides a substantially impermeable enclosure for the device 100, providing a leak-proof and protective enclosure to protect the contents of the absorbent material 114 contained within the chamber 112 and / or maintain a sealed, sterile environment. The peelable seal 150 provides a sufficient seal over a range of temperatures, pressures, and humidity levels.

[0044] The inner wall surface 124 includes internal threads adjacent the closed end 106. The internal threads are sized to accommodate engagement with a female luer connector. After the male luer connector, the female luer connector, and the hemodialysis connector are inserted into the open end 110 of the cap 102, the absorbent material 114 and the disinfectant or antimicrobial agent contact the male luer connector, the female luer connector, and the hemodialysis connector.

[0045] 1 and 2, in one or more embodiments, the outer wall surface 122 of the cap 102 includes a plurality of gripping members 136.

[0046] Referring to FIG. 3, the cap 102 has a cap wall length L extending from the cap closed end 106 to the cap open end 110. C The cap 102 has an annular cap wall 108 having an inner wall surface 124 and an outer wall surface 122.

[0047] In one or more embodiments, the female connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlusClear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave, MicroClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0048] In one or more embodiments, the male connector may be an intravenous tubing end, a stopcock, or a male locking luer.

[0049] In one or more embodiments, the male luer connector rests on a peripheral ledge when fully inserted into chamber 112 .

[0050] In one or more embodiments, the internal threads may extend partially along the length of the inner wall surface 124 of the cap 102 and be located adjacent the closed end 106 of the cap 102 .

[0051] In one or more embodiments, the male luer connector, upon insertion into the chamber 112, frictionally engages the inner wall surface 124 via a press-fit connection.

[0052] Referring to FIG. 4, in one or more embodiments, an opening 138 adjacent the open end 110 of the inner wall surface 124 of the cap 102 is sized to receive a male luer connector in a press-fit connection.

[0053] Referring to FIG. 5, the resilient sealing ring 126 comprises an elastomeric material.

[0054] In one or more embodiments, the elastomeric material of the resilient sealing ring 126 comprises a thermoplastic elastomer.

[0055] 1 and 7-8, in one or more embodiments, a locking lid 130 can engage with the engagement surface 120 to secure the resilient sealing ring 126 to the open end 110. The locking lid 130 includes an end surface 132. The locking lid 130 prevents the resilient sealing ring 126 from moving during insertion of a male or female luer connector into the expandable opening 128 of the resilient sealing ring 126. The locking lid 130 can be attached to the cap 102 using a variety of methods, including, but not limited to, mechanical fasteners, snap fittings, and threaded connections.

[0056] 1 and 7-8, in one or more embodiments, the locking lid 130 includes a peripheral sidewall 140 extending substantially perpendicularly from a base 142. The locking lid 130 is adapted to snap onto the open end 110 of the cap 102. With reference to FIG. 8, in one or more embodiments, the locking lid 130 may be connected to the cap 102 using a rim 144 disposed between the locking lid 130 and the cap 102.

[0057] In one or more alternative embodiments, the inner surface 146 of the peripheral sidewall 140 of the locking lid 130 or the annular outer wall surface 122 of the cap 102 at the open end 110 includes at least one protrusion 148 that corresponds to at least one mating protrusion 152 disposed on the inner surface 146 of the peripheral sidewall 140 of the locking lid 130 or the annular outer wall surface 122 of the cap 102. The protrusion 148 and the mating protrusion 152 engage to form a leak-proof connection between the locking lid 130 and the cap 102 when the locking lid 130 is connected to the mating protrusion 152 by the protrusion 148. In one or more embodiments, the protrusion 148 and the mating protrusion 152 are threads.

[0058] In one or more embodiments, the locking lid 130 is a snap-fit connection. In one or more embodiments, the snap-fit connection includes a protruding edge and a snap-in area. The protruding edge may be located on the inner surface 146 of the peripheral sidewall 140 of the locking lid 130 or on the annular outer wall surface 122 of the cap 102 at the open end 110, with a corresponding snap-in area located on the surface opposite the protruding edge such that the protruding edge and the snap-in area interlock.

[0059] Cap 102 and locking lid 130 may be made from any of a number of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, cap 102 comprises a polypropylene or polyethylene material. In one or more embodiments, outer wall 122 includes a plurality of gripping members 136.

[0060] 3 and 9 and 10, in one or more embodiments, the absorbent material 114 is radially compressed by internal threads to retain the absorbent material 114 within the chamber 112. In one or more embodiments, the absorbent material 114 is a nonwoven material, a foam, or a sponge. In certain embodiments, the foam is polyurethane foam. In certain embodiments, the absorbent material 114 is in the form of a foam plug. In one or more embodiments, the absorbent material 114 includes one or more slits 154.

[0061] When used with a luer connector, the device 100 can achieve disinfection by incorporating a disinfectant or antimicrobial agent within the chamber 112 of the cap 102. The disinfectant or antimicrobial agent can be placed directly within the chamber 112, or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam that fills the chamber of the cap 102. The device is designed to interact with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antibacterial agent is a fluid or gel.

[0062] When connecting to a female or male luer connector, compressing the absorbent material 114 towards the closed end 106 of the chamber 112 allows the connector to come into contact with a disinfectant or antimicrobial agent, thereby disinfecting the female or male luer connector.

[0063] 1, a peelable seal 150 on the end face 132 prevents the disinfectant or antimicrobial agent from exiting the chamber 112. In one or more embodiments, the peelable seal 150 can be disposed on the end face 132 to prevent the disinfectant or antimicrobial agent from exiting the chamber.

[0064] In one or more embodiments, the peelable seal 150 includes a peel-back top of aluminum or a multilayer polymer film. In certain embodiments, the peelable seal 150 is heat-sealed or induction-sealed to the end face of a locking lid or the open end of a cap. In one or more embodiments, the peelable seal 150 includes a moisture barrier.

[0065] The device 100 of the present disclosure is capable of disinfecting connectors for seven consecutive days. The device 100 of the present disclosure minimizes the introduction of microbial agents.

[0066] In one or more embodiments, the cap exterior wall 122 includes a plurality of gripping members 136 .

[0067] Currently available disinfection caps can disinfect only one of three types of luer fittings: female luer connectors for needleless connectors, female luer connectors for stopcocks, and male luer connectors for intravenous injection sites. Therefore, to avoid having to use different types of disinfection caps to clean different types of connectors, the device 100 with the cap 102 also engages with male and female luer connectors, thereby allowing users to clean different types of connectors with a single device. When the cap 102 is attached to the female luer connector, the female luer connector is inserted into the chamber 112 and threaded onto the cap's threads. When the cap is attached to the male luer connector, the male luer connector frictionally engages with the inner wall 124 upon insertion into the chamber 112. Therefore, the device of the present disclosure can be attached to both male and female luer connectors, thereby fulfilling a current need in the art.

[0068] Another aspect of the present disclosure relates to a method for disinfecting medical connectors and assemblies. In one or more embodiments, the method for disinfecting a medical connector includes connecting an apparatus of one or more embodiments to the medical connector, the connecting step including frictionally engaging an inner wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

[0069] In one or more embodiments, the assembly includes the device of one or more embodiments connected to a medical connector, hi one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and a needleless connector.

[0070] 11-14, in one or more embodiments, the cap of a device of the present disclosure can form a fluid-tight seal with the male luer connector 200, the female luer connector 300, or the hemodialysis connector 400. Referring to FIGS. 11-14, in one or more embodiments, the cap of a device of the present disclosure is tapered to form a fluid-tight seal with the male luer. In certain embodiments, the cap complies with ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) for forming a seal with a male luer connector.

[0071] In one or more embodiments, the cap of a device of the present disclosure has threads sized and pitch to engage a threadable segment of a female connector, such as a female Luer connector. Such connectors are generally and commonly used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, the cap provides a protective cover for the female Luer connector when engaged with the female Luer connector, where threads from the female Luer connector engage with the threads of the cap to form a releasable connection.

[0072] In some embodiments, the connector comprises a needleless injection site, which may also be referred to as a needleless injection port, hub, valve, or device, or a needleless access site, port, hub, valve, or device, such as Clave® (available from ICU Medical, Inc.), SmartSite® (available from Cardinal Health, Inc.), and Q-Syte TM(available from Becton, Dickinson and Company). In some embodiments, the cap can be connected to any of a variety of different needleless injection sites, such as those listed above. In one or more embodiments, after the cap is mated to the connector, the connector remains uncontaminated while mated with the cap, eliminating the need to disinfect the connector (e.g., treat with alcohol swabs) before it is reconnected to another connector. The use of the cap replaces the standard wiping procedure for cleaning the connector.

[0073] In one or more embodiments, the threads of the cap are sized and pitched to mate with the threads of a male luer lock connector. For example, the connector can comprise the end of an IV tubing set separate from an IV catheter needleless injection site.

[0074] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that a particular configuration, structure, material, or feature described in connection with this embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, particular configurations, structures, materials, or features may be combined in any suitable manner in one or more embodiments.

[0075] Although the disclosure herein has provided a description 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 be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the present disclosure. Therefore, it is intended that the present disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. A device for connecting to a medical connector, comprising: a cap, an absorbent material, a resilient sealing ring, a locking lid, and a peelable seal; the cap comprises a unitary body, a closed end, and an annular wall having a length LC extending from the closed end to an open end defining a chamber containing an absorbent material and a disinfectant or antimicrobial agent, the open end having a peripheral ledge and an engagement surface extending radially inward from the open end defining an end face; the annular wall has an outer wall surface and an inner wall surface; the elastic seal ring has a radially expandable circular opening for frictionally engaging and receiving a male luer connector and a female luer connector, the male luer connector frictionally engaging with the inner wall surface of the chamber when inserted into the elastic seal ring; the locking lid engages the engagement surface to secure the resilient sealing ring to the open end, and the locking lid has an end surface; The device, wherein the peelable seal is on an end face of the locking lid to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

2. 10. The device of claim 1, wherein the expandable opening is sized to frictionally engage a male luer connector.

3. 10. The device of claim 1, wherein the male luer connector is an intravenous tubing end, a stopcock, or a male locking luer.

4. The apparatus of claim 1 , wherein the resilient seal ring contacts the peripheral ledge.

5. 10. The device of claim 1, wherein the expandable opening has an expandable diameter from an initial diameter in the range of 7 to 9 mm to an expanded diameter in the range of 9 to 12 mm.

6. The device of claim 1 , further comprising internal threads extending partially along the length of the inner wall surface and adjacent the closed end.

7. The apparatus of claim 1 , wherein the peripheral ledge is sized to receive a resilient sealing ring.

8. The device of claim 1 , wherein the cap comprises a polypropylene or polyethylene material.

9. The apparatus of claim 1 , wherein the resilient sealing ring comprises an elastomeric material, preferably wherein the elastomeric material comprises a thermoplastic elastomer.

10. The device of claim 1 , wherein the absorbent material has slits.

11. 2. The device of claim 1, wherein compression of the absorbent material towards the closed end of the chamber occurs upon connection to the female luer connector or the male luer connector, and preferably, compression of the absorbent material disinfects the female luer connector or the male luer connector.

12. The device of claim 1 , wherein the absorbent material is radially compressed by the internal threads to retain the absorbent material within the chamber.

13. 2. The device of claim 1, wherein the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof; preferably, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

14. The device of claim 1 , wherein the peelable seal comprises an aluminum or multilayer polymer film peel-back top.

15. The device of claim 1 , wherein the peelable seal is heat sealed or induction sealed to the mating surface.

Images