Disinfection Cap

Abstract

An antiseptic cap for connection to a medical connector is described, the antiseptic cap including a housing having a top wall and side walls forming a cavity, a closure structure disposed on the top wall of the cavity that fluidly occludes a hub of a luer connector, and an antiseptic or antibacterial agent disposed within an open-cell foam structure within the cavity, the open-cell foam structure releasing the antiseptic or antibacterial agent when the open-cell foam structure is depressed by the hub of the luer connector.

Description

[Technical Field]

[0001] The present disclosure relates to an antiseptic cap device for disinfecting a corresponding medical connector. The present disclosure generally relates to an apparatus for disinfecting and sterilizing an access port of a medical connector having a fitting. In general, exemplary embodiments of the present disclosure relate to the field of threaded or mating fittings, including medical caps and medical antiseptic caps, particularly caps and / or antiseptic caps for use with threaded fluid connectors. One or more exemplary embodiments of the present disclosure relate to a male antiseptic cap device for disinfecting a male threaded Luer connector. [Background technology]

[0002] Vascular access devices (VADs) are commonly used therapeutic devices, including intravenous (IV) catheters. There are two general categories of VADs: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system through access hubs, ports, or valves at the VAD's connections for delivering fluids and medications. Each access hub, port, valve, or connection carries a significant risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal. To reduce the incidence of CRBSIs and ensure VADs are properly used and maintained, standards of practice, including disinfection and cleaning procedures, have been developed. Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) and the Infusion Nurses Society (INS) guidelines.

[0003] In developed markets, when using IV catheters, a needleless connector is typically used to close the system, which is then accessed to administer medications or other necessary fluids to the patient via the catheter. INS practice guidelines recommend the use of needleless connectors and state that they should be thoroughly disinfected before each access using alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination. Disinfection of needleless connectors is intended to ultimately help reduce bacteria that inhabit their surfaces and potentially lead to various catheter-related complications, including CRBSI. Nurses typically complete this disinfection process by using a 70% isopropyl alcohol (IPA) pad, a process known as "scrubbing the hub." However, adherence to this practice is typically very low. In addition to a lack of adherence to "scrubbing the hub," clinician interviews often noted variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0004] There is an increasing need to protect female and male Luer connectors to reduce central line-associated bloodstream infections (CLABSIs) and peripheral line-associated bloodstream infections (PLABSIs). The connection between an intravenous gravity set and a threaded male Luer on a syringe is subject to contamination if not properly protected. Currently, when an IV connector is disconnected from a central or peripheral line to temporarily halt an infusion, nurses often loop the male Luer connector into a Y-site needleless connector or wrap the male Luer connector in a piece of clean cotton or cloth saturated with isopropyl alcohol ("IPA"). However, such protection is very weak and does not adequately protect the Luer from contact contamination. Male disinfection caps have become the state-of-the-art disinfection and protection device for disinfecting male Luer connectors and creating a physical barrier to prevent microbial growth.

[0005] Numerous risks of contact or contamination exist throughout the entire sequence of procedures related to the transmission of microorganisms that can cause CRBSI. For example, contamination can occur during drug mixing, cannula attachment, and insertion into the access hub. Furthermore, threaded male Luer connectors have open Luers with exposed lumens. Because the procedure of connecting a VAD is so common and simple, the risks associated with entry into the patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is substantially a function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable. Summary of the Invention [Problem to be solved by the invention]

[0006] Disinfectants typically have a threshold limit for systemic exposure as a result of injection into the bloodstream due to the biotoxicity of the disinfectant at high doses. Therefore, there is a need for a disinfection device that can occlude the lumen of an open luer to facilitate mitigation of the ingress of such disinfectants into the connector, thereby reducing the risk of the disinfectant entering the bloodstream. There is a need for a mechanism that prevents the disinfectant from entering the lumen and fluid pathway while providing effective disinfection of the surrounding connector or fitting. [Means for solving the problem]

[0007] summary A first aspect of the present disclosure relates to an antiseptic cap having a housing including a top wall, a cylindrical side wall, and an open bottom formed by the cylindrical side wall. The cylindrical side wall has an inner surface defining a cavity. The open bottom has an opening to the cavity for receiving a hub of a Luer connector.

[0008] An occlusion structure is disposed within the cavity. The occlusion structure is configured as a cylindrical protrusion disposed on the upper wall of the housing. The cylindrical protrusion fluidly occludes the hub of the luer connector. A fluid releasably retained within a depressible, open-cell foam structure is disposed within the cavity. The hub of the luer connector is received within the inner surface of the cavity.

[0009] In one or more embodiments, the cavity extends essentially from the inner surface of the top wall toward the open bottom of the housing.

[0010] In one or more embodiments, the cylindrical protrusion is permanently disposed on the top wall of the housing.

[0011] In one or more embodiments, the open-cell foam structure is disposed in contact with the upper wall, hi one or more embodiments, the open-cell foam structure has a hollow cylindrical shape configured to fit snugly around the cylindrical protrusion.

[0012] In one or more embodiments, the cylindrical protrusion further includes an upper portion and a lower portion, the upper portion having a diameter equal to the upper wall and the lower portion having a smaller diameter than the upper portion, the lower portion configured to fluidly occlude the hub of the Luer connector.

[0013] In one or more embodiments, the open-cell foam structure is disposed in contact with the bottom surface of the upper portion of the cylindrical protrusion, and the open-cell foam structure has a hollow cylindrical shape configured to fit snugly around the lower portion of the cylindrical protrusion.

[0014] In one or more embodiments, a second depressible open-cell foam is disposed between the top of the cylindrical protrusion and the upper wall of the cavity. The second open-cell foam structure releasably retains fluid.

[0015] In one or more embodiments, the antiseptic cap further includes at least one thread on an exterior surface of the housing, the at least one thread being sufficient to mate with a mating structure of a luer connector.

[0016] In one or more embodiments, the hub is secured within the interior surface of the cavity by coupling at least a portion of at least one screw to a mating structure on the hub of the luer connector.

[0017] In one or more embodiments, the inner surface of the cavity is secured by an interference fit with the hub of the luer connector.

[0018] In one or more embodiments, the fluid 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 acetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0019] A second aspect of the present disclosure relates to an antiseptic cap having a housing including a top wall with an opening partially extending into the housing, a cylindrical side wall with an inner surface defining a cavity, and an open bottom formed by the cylindrical side wall with an opening to the cavity within the housing for receiving a hub of a luer connector. An umbrella-shaped stopper includes a stem, the stem being at least partially disposed in the opening in the top wall. The umbrella-shaped stopper further includes a fan-shaped barrier configured as a closure structure for fluidly blocking the hub of a medical device. The fan-shaped barrier creates a fluid-tight seal with the inner surface of the side wall. Fluid is releasably retained within the cavity and the fan-shaped barrier of the umbrella-shaped stopper. The hub of the luer connector is received within the inner surface of the cavity. Fluid is released when the fan-shaped barrier deforms when moved relative to the hub.

[0020] In one or more embodiments, the umbrella stopper further includes a rounded or chamfered end configured to fluidly occlude the hub of the luer connector. In one or more embodiments, the fan-shaped barrier is at a right angle to the stem. In one or more embodiments, the fan-shaped barrier is at an obtuse angle to the stem.

[0021] A third aspect of the present disclosure relates to an antiseptic cap having a housing including a top wall, a cylindrical side wall having an inner surface defining a cavity, and an open bottom formed by the cylindrical side wall with an opening to the cavity within the housing for receiving a luer connector hub. A closure structure is disposed within the cavity, the closure structure being configured as a plurality of hydrophilic bristles. The hydrophilic bristles are disposed on the top wall of the housing, and the hydrophilic bristles fluidly occlude the luer connector hub, with fluid being releasably retained within the hydrophilic bristles. The luer connector hub is received within the inner surface of the cavity.

[0022] In one or more embodiments, the antiseptic cap further includes a movable conical stopper, the conical stopper including an upper portion and a lower portion, the upper portion including a flange having a diameter smaller than the diameter of the cavity, the upper portion further including a lumen extending therethrough, and the cavity including a protrusion configured as a secondary occlusion structure, where the protrusion occludes the hub of the luer connector.

[0023] A fourth aspect of the present disclosure relates to an antiseptic cap having a housing including an upper portion including a pair of winged projections configured to receive a membrane or pouch, a bulbous cavity for holding a fluid, and a fluid path fluidly connecting the bulbous cavity to a drain. The drain is disposed on the upper surface of the upper portion, and the drain includes a conical cavity having a lumen disposed on the bottom surface of the conical cavity. The lumen is in fluid communication with a cavity defined by the inner sidewall of the lower portion of the housing. At least two ribs extend from the upper surface to the center of the conical cavity, and the at least two ribs structurally secure the projections disposed within the cavity, the projections extending through the lumen. The projections are configured as a closure structure, with a lower portion having a diameter equal to or greater than the diameter of the hub of a medical device. The open bottom is formed by the cylindrical sidewall of the cavity, with an opening into the cavity within the housing for receiving the hub of a Luer connector.

[0024] In one or more embodiments, the hub of the luer connector is received within the interior surface of the cavity.

[0025] A fifth aspect of the present disclosure relates to an antiseptic cap having a housing including a top and an open bottom. The top has an engagement surface disposed around the periphery of the top surface. The engagement surface is configured to receive a membrane or pouch, the membrane or pouch having a dome shape defining a bulbous cavity for holding a fluid. The open bottom is formed by a cylindrical sidewall of the cavity with an opening to the cavity for receiving the hub of a luer connector. At least two vents or slits are disposed through the top surface of the top, and the at least two vents or slits are in fluid communication with the bulbous cavity of the top. The hub of the luer connector is received on the inner surface of the cavity. The bulbous cavity can be depressed or collapsed against the top surface of the top, thereby releasing fluid into the at least two vents or slits.

[0026] In one or more embodiments, the hub of the luer connector abuts the top wall of the cavity, and the top wall fluidly seals the hub of the luer connector. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a perspective view of an antiseptic cap according to a first exemplary embodiment of the present disclosure. FIG. [Figure 2] 1 is a cross-sectional view of an antiseptic cap along axis XX' according to a first embodiment of the present disclosure. FIG. [Figure 3A] FIG. 1 is a perspective view of a threaded connection according to a first embodiment of the present disclosure. [Figure 3B] FIG. 2 is a perspective view of a threaded connection along axis YY′ according to a first embodiment of the present disclosure. [Figure 4A] FIG. 1 is a perspective view of an antiseptic cap according to a first embodiment of the present disclosure. [Figure 4B] 1 is a perspective view of an antiseptic cap along axis ZZ' according to a first embodiment of the present disclosure. FIG. [Figure 5A] FIG. 10 is a cross-sectional view of an antiseptic cap according to a second embodiment of the present disclosure. [Figure 5B] FIG. 10 is an exploded cross-sectional view of an antiseptic cap according to a second embodiment of the present disclosure. [Figure 6] FIG. 10 is a cross-sectional view of an antiseptic cap according to a third embodiment of the present disclosure. [Figure 7A] FIG. 10 is a cross-sectional view of an antiseptic cap according to a fourth embodiment of the present disclosure. [Figure 7B] FIG. 10 is a cross-sectional view of an antiseptic cap according to a fourth embodiment of the present disclosure. [Figure 8A] FIG. 10 is a cross-sectional view of an antiseptic cap according to a fifth embodiment of the present disclosure. [Figure 8B] FIG. 10 is a cross-sectional view of an antiseptic cap according to a fifth embodiment of the present disclosure. [Figure 9] FIG. 10 is a cross-sectional view of an antiseptic cap according to a sixth embodiment of the present disclosure. [Figure 10A] FIG. 10 is a cross-sectional view of an antiseptic cap according to a sixth embodiment of the present disclosure. [Figure 10B] FIG. 10 is a cross-sectional view of an antiseptic cap according to a sixth embodiment of the present disclosure. [Figure 11]FIG. 10 is a cross-sectional view of an antiseptic cap according to a seventh embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0028] Detailed Description

[0003] Embodiments of the present disclosure relate to a medical connector, including a threaded connection, and a disinfection cap for disinfecting the medical connector. In one or more embodiments, the medical connector is a needleless connector or a luer connector. The present disclosure aims to provide a mechanism for preventing disinfectants from entering the medical connector's flow path while providing effective disinfection to the hub and surrounding surfaces of the medical connector.

[0029] 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. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0030] For purposes of the following description, the terms "upper," "lower," "right," "left," "vertical," "horizontal," "top," "bottom," "sideways," and "vertical," and their derivatives, shall refer to the present disclosure as oriented in the drawings. However, it should be understood that the present disclosure may contemplate alternative variations and process sequences, except where expressly specified to the contrary. It should also be understood that the specific devices and processes illustrated in the accompanying drawings and described in the following specification are merely exemplary embodiments of the present disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments disclosed herein are not to be considered limiting.

[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 a slightly tapered connecting tube that holds them together with a simple pressure / torsion fit. Luer connectors optionally include an additional threaded outer rim, making them more secure. The end of a Luer connector is typically integrated with a flush syringe and can mate and connect to the end located in a vascular access device (VAD). Luer connectors include 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 releasably attaches the Luer connector to the hub of the VAD and a proximal end channel that releasably attaches the Luer connector to the syringe barrel. As used herein, the term "Luer connector" refers to a Luer connector or a female Luer connector.

[0034] As used herein, the term "medical device" refers to a general medical device having a threaded or mating connection, the connection having a corresponding mating element. By way of example and not limitation, a syringe may have a threaded connection that releasably mates with a secondary medical device, such as a luer connection for a catheter, IV line, and the like. The threaded connection may include a lumen defining a fluid pathway surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0035] As will be readily understood by one of ordinary skill in the relevant art, descriptive terms such as "screw," "taper," "tab," "wall," "top," "side," "bottom," and the like are used throughout this specification for ease of understanding and are not intended to limit any components that may be used in combination or individually to implement various aspects of embodiments of the present disclosure.

[0036] An embodiment of the presently disclosed antiseptic cap includes a housing having an upper wall defining a closed end, an inner surface defining a cavity, an open end formed by a cylindrical sidewall with an opening to the cavity within the housing for receiving the hub of a threaded connection, and at least one thread on the outer surface of the cylindrical sidewall sufficient to mate with the mating structure of the threaded connection; a closure structure disposed within the cavity; and an antiseptic or antimicrobial agent retained within the cavity. The antiseptic cap embodiment discloses at least one thread on the antiseptic cap that engages with the mating structure of the threaded connection, more specifically, the Luer connection. The closure structure is configured to prevent ingress of the antiseptic into the flow path of the hub of the Luer connection. In one or more embodiments, the outer surface of the housing at the open end of the antiseptic cap includes a peripheral ledge extending radially outward from the open end, defining an end surface and an engagement surface for a peelable seal and / or septum to maintain sterility of the cavity. The peelable seal reduces or prevents contamination of the cavity during transportation and storage of the antiseptic cap. The peelable seal is generally maintained in a closed position until immediately prior to the injection and / or aspiration procedure, at which point the peelable seal is removed. The removable seal minimizes the introduction of potential particulate hazards and provides a substantially impermeable enclosure for the cavity prior to use of the antiseptic cap. The removable seal provides an adequate seal over a wide range of temperatures, pressures, and humidity levels.

[0037] The antiseptic cap provides a mechanical barrier to the connector and contains an antiseptic or antibacterial agent (hereinafter referred to as "fluid"). The antiseptic cap of the present disclosure allows practitioners to streamline the disinfection process. The matters illustrated in this description are provided to aid in a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, those skilled in the art will recognize that various changes and modifications of the embodiments described herein may be made without departing from the scope and spirit of the present disclosure. Additionally, for clarity and conciseness, descriptions of well-known functions and structures are omitted.

[0038] In particular, a practitioner can disinfect a luer connector of a medical device with one touch by inserting or threading the antiseptic cap onto the luer connector, which causes an occlusion structure to prevent fluid ingress into the luer connector's flow path, while the luer connector's hub simultaneously causes fluid egress, allowing disinfection of the luer connector hub and its surroundings. The antiseptic cap can then be removed from the luer connector of the medical device by removing or unscrewing the antiseptic cap and inserting or threading the antiseptic cap onto the luer connector, e.g., a Y-site connection or luer connector.

[0039] In exemplary implementations of embodiments of the present disclosure, the antiseptic cap includes integrated screws or tabs and other configurations, in any and all combinations, that allow it to mate with a threaded fitting of a medical device. In a preferred embodiment, the antiseptic cap mates with a Luer fitting. Exemplary configurations for couplers, fittings, ports, and adapters may include commercially available Luer locks, Luer slip ports, locking ports, threaded connections, mating connections, or other common medical device fittings commonly known in the art.

[0040] Referring now to the drawings, wherein like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described below.

[0041] As shown in FIGS. 1 and 2 , a first aspect of the present disclosure relates to an antiseptic cap 100 including a housing 110 having an upper portion 110A and a lower portion 110B. In one or more embodiments, the lower portion 110B is substantially cylindrical with a cylindrical housing 112. In further embodiments, the lower portion 110B may have a tapered lower portion. The upper portion 110A of the housing has an inwardly tapered sidewall. In further embodiments, the upper portion 110A and the lower portion 110B have substantially cylindrical sidewalls. In one or more embodiments, the inner surface 126 of the lower portion 110B of the housing 110 defines a cavity 130 having an open bottom 116 for receiving the hub of a Luer connector. In one embodiment, the upper portion 110A is integrally formed with the lower portion 110B, while further embodiments are permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0042] In one or more embodiments, the cavity 130 can be configured to facilitate a loose fit between the cavity 130 and the hub of a Luer connector, and the antiseptic cap 100 is secured by at least one screw 122 or a set of tabs included on the exterior surface of the cylindrical housing 112. The at least one screw 122 located on the exterior surface of the cylindrical housing 112 is sized and has a thread pattern that engages with a standard ISO-2 type fitting. The loose fit allows fluid to flow around the hub of the Luer connector. In further embodiments, the cavity 130 can be configured for a Luer slip fitting, facilitating an interference fit between the cavity 130 and the hub of the Luer connector. The interference fit can be configured to be strong enough to eliminate the need for a threaded connection or the at least one screw 122 when removably securing the cavity 130 to the Luer connector.

[0043] In one or more embodiments, when the hub of a Luer connector is received within the inner surface 126 of the cavity 130, the hub is secured within the cavity 130 of the antiseptic cap 100 by coupling at least a portion of the at least one thread 122 to a mating structure on the hub of the Luer connector. In one or more embodiments, the at least one thread 122 may include an oblique thread pattern. In one or more embodiments, the at least one thread 122 may include a helical thread pattern. Such connectors are common and typically used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, the antiseptic cap 100 provides a protective cover for the Luer connector when engaged with the connector, as threads from the Luer connector engage with the at least one thread 122 of the antiseptic cap 100 to form a removable connection.

[0044] FIG. 2 shows a cross-sectional view of the antiseptic cap 100 taken along the X-X' plane shown in FIG. 1. As shown in FIG. 2, the cavity 130 of the housing 110 extends from the open bottom 116 to the top wall 114 for a length Lc of the entire length of the housing 110, and the cavity 130 has a substantially cylindrical shape. Extending from the top wall 114 is a protrusion 118 configured as a sealing structure for a lumen extending through the hub of a luer connector of a medical device. In a preferred embodiment, the protrusion 118 is substantially cylindrical and continuously connected to the top wall 114. The diameter of the protrusion 118 is sized and configured to fluidly occlude the lumen of the luer connector. In one or more embodiments, the protrusion 118 is substantially conical. In one or more embodiments, the end 124 of the protrusion 118 is rounded or chamfered to aid in inserting the protrusion 118 into the lumen of the luer connector.

[0045] An open-cell foam structure 120 for absorbing and retaining fluid may be disposed in contact with the upper wall 114. In a preferred embodiment, the open-cell foam structure 120 has a hollow cylindrical shape configured to fit snugly around the protrusions 118 and not extend beyond them. The open-cell foam structure 120 is compressible both horizontally and vertically, allowing the open-cell foam structure 120 to create an interference fit with the inner surface 126 of the cavity 130. The open-cell foam allows fluid to escape when the open-cell foam structure 120 is compressed. When the antiseptic cap 100 is threaded or pressed onto a luer connector, the luer connector lumen is fluidly sealed and occluded by the protrusions 118, while the luer connector hub compresses the open-cell foam structure 120, causing the open-cell foam structure 120 to expel fluid that disinfects the luer connector hub and surrounding area. In a preferred embodiment, the open cell foam structure 120 may be neoprene, polyurethane, natural rubber, or a medical grade open cell foam with a low or zero cytotoxicity rating suitable for sterilization.

[0046] An exemplary luer connector 170 is shown in FIGS. 3A and 3B, with FIG. 3B showing a cross-section along plane Y-Y'. The luer connector 170 includes a lumen 172 disposed through a hub 174 having a conical surface, a mating structure having at least one thread 176, and a mating surface 178 disposed at the bottom of the hub 174. FIGS. 4A and 4B show the antiseptic cap 100 fully inserted into the luer connector 170, with FIG. 4B showing a cross-section along plane Z-Z'. As shown, the at least one thread 122 of the antiseptic cap 100 fully engages with the at least one thread 176 of the luer connector 170 and is releasably secured. In this position, the engagement surface of the antiseptic cap 100 abuts the mating surface 178 of the luer connector 170. In this position, the hub 174 fully presses against the open-cell foam structure 120, thereby expelling any fluid contained in the open-cell foam structure 120 and disinfecting the area around the hub 174 and the luer connector 170, while the protrusion 118 of the disinfection cap 100 fluidly seals the lumen 172 of the luer connector 170 and prevents fluid from entering the fluid path of the lumen 172 of the luer connector 170.

[0047] Further embodiments of the antiseptic cap are contemplated, including alternative closure structures. An exemplary antiseptic cap includes a housing having an upper and lower portion. In one or more embodiments, the lower portion of the sidewall is substantially cylindrical, resulting in a cylindrical housing, while further embodiments may have a tapered housing. The upper portion of the housing has an inwardly tapered sidewall, while further embodiments have a substantially cylindrical sidewall. In one or more embodiments, the inner surface of the lower portion of the housing defines a cavity with an open bottom for receiving the hub of a Luer connector.

[0048] In one or more embodiments, the exemplary cavity may be configured to facilitate a loose fit between the cavity and the hub of a Luer connector, and the exemplary antiseptic cap is secured by at least one screw or a set of tabs included on the exterior surface of the cylindrical housing. The loose fit allows fluid to flow around the hub of the Luer connector. In further embodiments, the exemplary cavity may be configured with a Luer slip connection to facilitate an interference fit between the cavity and the hub of the Luer connector. The interference fit may be configured to be strong enough to obviate the need for a threaded connection or at least one thread 122 when removably securing the cavity to the Luer connector.

[0049] In one or more embodiments, when the hub of the Luer connector is received within the interior surface of the cavity, the hub is secured within the cavity of the antiseptic cap by coupling at least a portion of the at least one thread to a mating structure of the hub of the Luer connector. In one or more embodiments, the at least one thread may include an oblique thread pattern. In one or more embodiments, the at least one thread may include a helical thread pattern. Such connectors are common and typically used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, the antiseptic cap provides a protective cover for the Luer connector when engaged with the connector, as threads from the Luer connector engage with and form a releasable connection with the at least one thread of the antiseptic cap.

[0050] 5A and 5B show an exemplary antiseptic cap 200 according to a second embodiment of the present disclosure, with FIG. 5B showing an exploded view and FIG. 5A and FIG. 5B showing a cross section of the exemplary antiseptic cap 200. The antiseptic cap 200 includes a housing 210 having a lower portion, an inner surface 226 of the lower portion of the housing 210 defining a cavity 230 having an open bottom 216 for receiving the hub of a luer connector.

[0051] Cavity 230 of housing 210 extends a length Lc of the entire length of housing 210 from open bottom 216 to top wall 214, and cavity 230 has a substantially cylindrical shape. Stopper 218 abuts top wall 214, and stopper 218 is configured as an occlusion structure for a lumen that extends through the hub of a luer connector of a medical device.

[0052] The stopper 218 in preferred embodiments is substantially cylindrical and has an upper portion 228 and a lower portion 223, which are integrally formed. The upper portion 228 has a diameter the same as or larger than the upper wall 214, creating an interference fit that removably retains the stopper within the cavity 230. The diameter of the lower portion 223 of the stopper 218 is sized and configured to fluidly occlude the lumen of the luer connector. In one or more embodiments, the lower portion 223 has a substantially conical shape. In one or more embodiments, the end 224 of the lower portion 223 is rounded or chamfered to aid in inserting the lower portion 223 into the luer connector lumen. The diameter of the upper portion 228 is larger than the diameter of the lower portion 223. In preferred embodiments, the stopper 218 is coupled to the upper wall 214 of the cavity 230 of the antiseptic cap 200 by an interference fit connection, a medical-grade adhesive connection, or a combination thereof. The stopper 218 can be rubber, TPE, or plastic.

[0053] An open-cell foam structure 220 for absorbing and retaining fluid may be positioned in contact with the underside of the upper portion 228 of the stopper 218. In a preferred embodiment, the open-cell foam structure 220 has a hollow cylindrical shape and is configured to fit snugly around the lower portion 223 of the stopper 218 and not extend beyond the lower portion 223. The open-cell foam structure 220 is compressible both horizontally and vertically, allowing the open-cell foam structure 220 to create an interference fit with the inner surface 226 of the cavity 230. The open-cell foam structure 220 allows fluid to escape when the open-cell foam structure 220 is compressed. When the antiseptic cap 200 is threaded or pressed onto the luer connector, the luer connector lumen is fluidly sealed and occluded by the stopper 218, while the luer connector hub compresses the open-cell foam structure 220, releasing fluid that disinfects the hub and the area around the luer connector. In a preferred embodiment, the open cell foam structure 220 may be neoprene, polyurethane, natural rubber, or a medical grade open cell foam with a low or zero cytotoxicity rating suitable for sterilization.

[0054] 6 illustrates an exemplary antiseptic cap 300 according to a third embodiment of the present disclosure. The antiseptic cap 300 includes a housing 310 having an upper portion 304, a lower portion 306, and an inner surface 326 of the lower portion of the housing 310, the inner surface 326 of the lower portion of the housing 310 defining a cavity 330 with an open bottom 316 for receiving the hub of a Luer connector. The upper portion 304 of the antiseptic cap 300 has a larger diameter than the lower portion 306, and the upper portion 304 serves as a gripping surface for a practitioner to manipulate the antiseptic cap 300. In one embodiment, the upper portion 304 is integrally formed with the lower portion 306, while further embodiments are permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0055] The cavity 330 of the housing 310 extends from the open bottom 316 to the top wall 314 for a length Lc of the entire length of the housing 310, and the cavity 330 has a substantially cylindrical shape. The first open-cell foam structure 319 for absorbing and retaining fluid has a cylindrical shape and substantially abuts the top wall 314.

[0056] The stopper 318 abuts the underside of the first open-cell foam structure 319, and the stopper 318 is configured as an occlusion structure for a lumen 372 extending through a hub 374 of a luer connector 370 of a medical device. The stopper 318 in a preferred embodiment is substantially cylindrical and has an upper portion 328 and a lower portion 323, which are integrally formed. The upper portion 328 has a diameter the same as or larger than the upper wall 314, creating an interference fit that removably retains the stopper within the cavity 330. The diameter of the lower portion 323 of the stopper 318 is sized and configured to fluidly occlude the lumen of the luer connector. In one or more embodiments, the lower portion 323 may have a substantially conical shape. In one or more embodiments, the end 324 of the lower portion 323 may be rounded or chamfered to aid in inserting the lower portion 323 into the lumen of the luer connector. The diameter of the upper portion 328 is larger than the diameter of the lower portion 323 , and the diameter of the upper portion 328 is smaller than the diameter of the first open-cell foam structure 319 .

[0057] A second open-cell foam structure 320 for absorbing and retaining fluid may abut the underside of the first open-cell foam structure 319. In a preferred embodiment, the open-cell foam structure 220 has a hollow cylindrical shape and is configured to fit snugly around the lower portion 323 of the stopper 318 and not extend beyond the lower portion 323. The first open-cell foam structure 319 and the second open-cell foam structure 320 have substantially the same outer diameter.

[0058] The first open-cell foam structure 319 and the second open-cell foam structure 320 are compressible in both horizontal and vertical directions, allowing the first open-cell foam structure 319 and the second open-cell foam structure 320 to create an interference fit with the inner surface 326 of the cavity 330. The first open-cell foam structure 319 and the second open-cell foam structure 320 allow fluid to escape when the first open-cell foam structure 319 and the second open-cell foam structure 320 are compressed. When the antiseptic cap 300 is threaded or pressed onto the luer connector, the luer connector lumen is fluidly sealed and occluded by the stopper 318, while the luer connector hub compresses the first open-cell foam structure 319 and the second open-cell foam structure 320, expelling fluid that disinfects the luer connector hub and surrounding area. In a preferred embodiment, first open-cell foam structure 319 and second open-cell foam structure 320 may be neoprene, EPDM, Viton®, polyurethane, natural rubber, or a medical-grade open-cell foam with a low or zero cytotoxicity rating that is suitable for sterilization.

[0059] 7A and 7B show an exemplary antiseptic cap 400 according to a fourth embodiment of the present disclosure. The antiseptic cap 400 includes a housing 510 having an upper portion 404, a lower portion 406, and a lower inner surface 426 of the housing 410, the lower inner surface 426 defining a cavity 430 with an open bottom 416 for receiving the hub of a Luer connector. The upper portion 404 of the antiseptic cap 400 has a larger diameter than the lower portion 406, and the upper portion 404 serves as a gripping surface for a practitioner to manipulate the antiseptic cap 400. In one embodiment, the upper portion 404 is integrally formed with the lower portion 406, while further embodiments are permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0060] The cavity 430 of the housing 410 extends from the open bottom 416 to the top wall 414 for a length Lc of the overall length of the housing 510, and the cavity 430 has a substantially cylindrical shape. The top wall 414 further includes an opening 415 that extends into the housing 510 for a length LA. The opening 415 extends toward the top 404.

[0061] A stem 428 of umbrella-shaped stopper 418 is at least partially disposed within opening 415. Stem 428 may be integrally formed within opening 415. In one or more embodiments, stem 428 may be permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof. Umbrella-shaped stopper 418 further includes a fan-shaped barrier 427, where umbrella-shaped stopper 418, and more specifically, fan-shaped barrier 427, are configured as an occlusion structure for lumen 472 extending through hub 474 of luer connector 470 of the medical device. Fan-shaped barrier 427 of umbrella-shaped stopper 418 creates a fluid-tight seal with inner surface 426 of cavity 430. The diameter of fan-shaped barrier 427 is essentially equal to the diameter of cavity 430. In one or more embodiments, the end 424 of the stem 428 may be rounded or chamfered to aid in inserting the stem 428 into the lumen 472 of the luer connector 470 .

[0062] Fluid is disposed within a chamber defined by the fan-shaped barrier 427 and the top of the cavity 430. When the antiseptic cap 400 is threaded or pressed onto the luer connector, the fan-shaped barrier 427 elastically deforms within the lumen 472 to create a fluid-tight seal, while the elastic deformation of the fan-shaped barrier 427 disrupts the fluid-tight seal between the fan-shaped barrier 427 and the cavity 430, releasing fluid that disinfects the hub and surrounding area of ​​the luer connector. In a preferred embodiment, the fan-shaped barrier 427 may be made of a deformable elastomeric material such as rubber or TPE.

[0063] 8A and 8B show an exemplary antiseptic cap 500 according to a fifth embodiment of the present disclosure. The antiseptic cap 500 includes a housing 510 having an upper portion 504, a lower portion 506, and an inner surface 526 of the lower portion 506 of the housing 510, the inner surface 526 of the lower portion 506 of the housing 510 defining a cavity 530 with an open bottom 516 for receiving the hub of a Luer connector. The upper portion 504 of the antiseptic cap 500 has a larger diameter than the lower portion 506, and the upper portion 504 serves as a gripping surface for a practitioner to manipulate the antiseptic cap 500. In one embodiment, the upper portion 504 is integrally formed with the lower portion 506, while further embodiments may be permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0064] The cavity 530 of the housing 510 extends from the open bottom 516 to the top wall 514 for a length Lc of the overall length of the housing 510, and the cavity 530 has a substantially cylindrical shape. A and includes an opening 515 extending into housing 510. A stem 528 of umbrella stopper 518 is at least partially disposed within opening 515. Stem 528 may be integrally formed with opening 515, while in further embodiments, stem 528 may be permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0065] Umbrella stopper 518 further includes a fan-shaped barrier 527, which is configured as an occlusion structure for a lumen 572 extending through a hub 574 of a luer connector 570 of a medical device. In an initial position shown in FIG. 8A , fan-shaped barrier 527 of umbrella stopper 518 creates a fluid-tight seal with an inner surface 526 of cavity 530. Fan-shaped barrier 527 is substantially conical, with an edge of fan-shaped barrier 527 configured to surround a portion of hub 574. Fan-shaped barrier 527 includes a plurality of ribs 529 radially arranged from stem 528, which help maintain the conical structure of fan-shaped barrier 527.

[0066] Fluid is disposed within a chamber defined by the fan-shaped barrier 527 and the top of the cavity 530. As shown in FIG. 8B , when the antiseptic cap 500 is screwed or pressed onto the luer connector into a final position, the fan-shaped barrier 527 elastically deforms within the lumen 572 to create a fluid-tight seal, while the elastic deformation of the fan-shaped barrier 527 disrupts the fluid-tight seal of the fan-shaped barrier 527 and cavity 530, releasing fluid that disinfects the hub and surrounding area of ​​the luer connector. In a preferred embodiment, the fan-shaped barrier 527 may be made of a deformable elastomeric material such as rubber or TPE.

[0067] 9 illustrates an exemplary antiseptic cap 600 according to a sixth embodiment of the present disclosure. The antiseptic cap 600 includes a housing 610 having an upper portion, a lower portion, and an inner surface 626 of the lower portion of the housing 610, the inner surface 626 of the lower portion of the housing 610 defining a cavity 630 with an open bottom 616 for receiving the hub of a Luer connector. The upper portion of the antiseptic cap 600 has a larger diameter than the lower portion, and the upper portion serves as a gripping surface for a practitioner to manipulate the antiseptic cap 600. In one embodiment, the upper portion is integrally formed with the lower portion, while further embodiments are permanently or removably assembled with a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0068] The cavity 630 of the housing 610 extends from the open bottom 616 to the top wall 614 for a length Lc of the entire length of the housing 610, and the cavity 630 has a substantially cylindrical shape. A plurality of hydrophilic bristles 618 extend from the top wall 614, the hydrophilic bristles 618 extending a distance less than the entire length of the cavity 630. The hydrophilic bristles 618 retain fluid. The hydrophilic bristles function as an occlusion structure by preventing fluid from entering a lumen 672 extending through a hub 674 of a luer connector 670 of the medical device. When the antiseptic cap 600 is threaded or pressed onto the luer connector, the hydrophilic bristles 618 elastically deform, occluding the lumen 672. Upon initial engagement, the hydrophilic bristles 618 are initially bunched and, upon advancement of the hub 674, are compressed into the opening of the lumen 672, preventing the inflow of additional disinfectant. Any disinfectant adsorbed to that portion of the bristles is forced into the surrounding bristle spaces and distributed to the exterior lumen surface.

[0069] 10A and 10B show an exemplary antiseptic cap 600 according to a sixth embodiment of the present disclosure. The antiseptic cap 600 includes a housing 610 having a top, a bottom, and an inner surface 626 of the bottom of the housing 610, the inner surface 626 of the bottom of the housing 610 defining a cavity 630 with an open bottom 616 for receiving the hub of a Luer connector. The top of the antiseptic cap 600 includes a pair of wing-like projections 640 configured to receive a membrane or pouch 642. The membrane or pouch 642 is secured to the wing-like projections 640 with a medical-grade adhesive. The pair of wing-like projections 640 may function as a gripping structure to assist the practitioner in threading or inserting the antiseptic cap 600 into the Luer connector. The membrane or pouch 642 includes a bulbous cavity 644 for holding a fluid 602. The bulbous cavity 644 can be depressed or collapsed on itself by the practitioner, thereby expelling the fluid 602 through a fluid pathway 646 and into a drain 648 of the antiseptic cap 600. The drain 648 is located on an upper surface 650 of the top of the antiseptic cap 600. The cavity 630 of the housing 610 extends from the open bottom 616 to the top wall 614 for a length Lc of the overall length of the housing 610, and the cavity 630 has a substantially cylindrical shape.

[0070] As shown in FIG. 10B , drain 648 includes a conical cavity 652 in fluid communication with a lumen 654 disposed at the bottom of conical cavity 652, which is in fluid communication with cavity 630 of housing 610. Extending from top surface 650 are at least two ribs 656, which extend to the center of conical cavity 652. At least two ribs 656 are configured to structurally secure protrusion 658, which extends into conical cavity 652 and lumen 654. Protrusion 658 includes an upper and lower portion, with the upper portion having a smaller diameter than the lower portion. The diameter of the upper portion is smaller than the diameter of lumen 654 of drain 648. The lower portion of protrusion 658 is configured as an occlusion structure, with the lower portion having a diameter equal to or larger than the diameter of the hub of a Luer connector of a medical device. The lower portion of the protrusion 658 fluidly seals the lumen of the hub of the luer connector when the antiseptic cap 600 is screwed or pressed onto the luer connector, allowing the bulbous cavity 644 to be depressed or collapsed, thereby releasing the fluid 602. The fluid 602 disinfects the hub and surrounding area of ​​the luer connector.

[0071] 11 illustrates an exemplary antiseptic cap 700 according to a seventh embodiment of the present disclosure. The antiseptic cap 700 includes a substantially cylindrical housing 710 having a top, a bottom, and an inner surface 726 of the lower portion of the housing 710, the inner surface 726 of the lower portion of the housing 710 defining a cavity 730 having an open bottom 716 for receiving the hub of a Luer connector. The top of the antiseptic cap 700 includes an engagement surface 740 disposed around the circumference of an upper surface 750 of the upper portion of the cylindrical housing 710. The engagement surface 740 is configured to receive a membrane or pouch 742, the membrane or pouch 742 having a dome shape defining a bulbous cavity 744 for holding the fluid 702. The membrane or pouch 742 is secured to the engagement surface 740 with a medical-grade adhesive. The bulbous cavity 744 can be pressed or collapsed by the practitioner onto the upper surface 850 of the upper portion of the cylindrical housing 710, thereby expelling the fluid 702 through a fluid pathway and into the lower cavity 730 of the housing 710. The fluid pathway is defined by at least two vent holes or slits 748 disposed through the upper surface 750 of the upper portion of the cylindrical housing 710. The slits facilitate fluid communication between the bulbous cavity 744 and the lower cavity 730 of the housing 710.

[0072] The cavity 730 of the housing 710 extends from the open bottom 716 to the top wall 714 for a length Lc of the entire length of the housing 710, and the cavity 730 has a substantially cylindrical shape. The overall length Lc of the housing 710 is substantially equal to the length of the hub 774 of the luer connector 770, and the top wall 714 is configured to function as a closure structure for the luer connector 770's lumen 772. By abutting the hub 774, the top wall 714 fluidly seals the luer connector 770's lumen 772 and prevents ingress of the fluid 702 from entering the lumen 772 when the fluid 702 is expelled from the at least two slits 748. Similarly, the at least two slits 748 are positioned a distance Ds from each other, whereby the at least two slits 748 expel the fluid 702 and disinfect the hub and surrounding area of ​​the luer connector.

[0073] The antiseptic cap (100, 200, 300, 400, 500, 600, 700) may achieve antisepticity when used with a luer connector by integrating the fluid (102, 202, 302, 402, 502, 602, 702) into the cavity (130, 230, 330, 430, 530, 630, 730) of the antiseptic cap (100, 200, 300, 400, 500, 600, 700). The fluid (102, 202, 302, 402, 502, 602, 702) may be contained directly in the cavity (130, 230, 330, 430, 530, 630, 730). The antiseptic cap (100, 200, 300, 400, 500, 600, 700) is designed to be compatible with interaction with a variety of antiseptic or antimicrobial agents or fluids (102, 202, 302, 402, 502, 602, 702). In one or more embodiments, the antiseptic or antimicrobial agents or fluids (102, 202, 302, 402, 502, 602, 702) may include various types of alcohol or chlorhexidine. In one or more embodiments, the antiseptic or antimicrobial agents or fluids (102, 202, 302) may include various types of alcohol or chlorhexidine.

[0074] In one or more embodiments, the fluid (102, 202, 302, 402, 502, 602, 702) is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, 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 antiseptic or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent (102, 202, 302, 402, 502, 602, 702) is a fluid or a gel.

[0075] In one or more embodiments, the antiseptic cap (100, 200, 300, 400, 500, 600, 700) may include a removable peel seal covering the opening to the cavity (130, 230, 330, 430, 530, 630, 730). In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film tear-off lid. In certain embodiments, the peelable is heat-sealed or induction-sealed to the open end of the antiseptic cap (100, 200, 300, 400, 500, 600, 700). In one or more embodiments, the peelable seal comprises a moisture barrier.

[0076] The antiseptic cap (100, 200, 300, 400, 500, 600, 700) is 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, the antiseptic cap (100, 200, 300, 400, 500, 600, 700) comprises a polypropylene or polyethylene material.

[0077] In one or more embodiments, the connector of the medical device may be selected from the group consisting essentially of needleless connectors, catheter luer connectors, stopcocks, and primary IV gravity sets, secondary IV gravity sets, extension sets, and hemodialysis connectors on infusion or syringe pump sets. In some embodiments, the antiseptic cap may be connected to any of a variety of different needleless injection sites. In one or more embodiments, after the antiseptic cap is mated with the connector, the connector is kept uncontaminated while mated with the antiseptic cap, eliminating the need to disinfect the connector (e.g., treat with an alcohol swab) before each reconnection of the connector to another connector. The use of the antiseptic cap (100, 200, 300, 400, 500, 600, 700) replaces standard swabbing protocols for cleaning connectors.

[0078] Yet another aspect of the present disclosure relates to a method for disinfecting a medical connector, the method comprising connecting one or more embodiments of an antiseptic cap (100, 200, 300, 400, 500, 600, 700) to the medical connector, the connecting comprising inserting the medical connector into the antiseptic cap (100, 200, 300, 400, 500, 600, 700) to engage threads on the medical connector with threads on an exterior surface of a sidewall of a housing (110, 210, 310, 410, 510, 610, 710) of the antiseptic cap, thereby contacting the medical connector with an occlusion structure.

[0079] A further aspect of the present disclosure relates to an assembly. The assembly includes one or more embodiments of an antiseptic cap (100, 200, 300, 400, 500, 600, 700) connected to a medical connector. In one or more embodiments, the medical connector is selected from a luer connector or other needleless connector having a fitting. In one or more embodiments, the luer connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector.

[0080] A further aspect of the present disclosure relates to packaging. In one or more embodiments, antiseptic caps (100, 200, 300, 400, 500, 600, 700) can be packaged in a strip structure. The strip structure can include a single piece of top web to which multiple caps (100, 200, 300, 400, 500, 600, 700) are attached via a sealing layer. The strip structure can also include a series of individually sealed caps with individual top web foils, which are then arranged and attached to a single strip of material such as plastic. The individual top web foils can have tabs attached to the strip material via an adhesive or sealant.

[0081] It is expected that the antiseptic caps (100, 200, 300, 400, 500, 600, 700) disclosed herein and shown in the figures may also be utilized with luer connectors, including female luer connectors, and that an occlusion structure may be used to occlude the open luer lumen to facilitate mitigating the ingress of such antiseptic into the connector, thereby reducing the risk of the antiseptic entering the bloodstream. Accordingly, it is expected that the antiseptic caps (100, 200, 300, 400, 500, 600, 700) disclosed herein and shown in the figures may be utilized with both types and female luer connectors.

[0082] While the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. Also, the inner and / or outer housing of the antiseptic cap can be single-shot molded or made by other suitable processes. Furthermore, any of the features or elements of any exemplary implementation of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination, as would be readily apparent to one skilled in the art, without departing from the spirit and scope of the embodiments of the present disclosure.

[0083] Additionally, the included drawing figures further illustrate non-limiting examples of the implementation of certain exemplary embodiments of the present disclosure and aid in the description of the technology associated therewith.Other than as noted above, specific or relative dimensions or measurements provided in the drawings are exemplary and are not intended to limit the scope or content of the claims.

[0084] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "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 present disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0085] Although the disclosure herein provides 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, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. 1. An antiseptic cap having a housing, a top wall having an opening extending partially into the housing; a cylindrical sidewall having an inner surface defining a cavity; an open bottom formed by said cylindrical sidewall with an opening to said cavity in said housing for receiving a hub of a luer connector; an umbrella-shaped stopper including a stem at least partially disposed in the opening in the top wall, the umbrella-shaped stopper further including a fan-shaped barrier configured as a closure structure for fluidly occluding a hub of a medical device, the fan-shaped barrier creating a fluid-tight seal with the inner surface of the cylindrical side wall; a fluid releasably retained between the cavity and the fan-shaped barrier of the umbrella-shaped stopper; The hub of the Luer connector is received within the inner surface of the cavity, and the fan-shaped barrier deforms when moved relative to the hub, thereby releasing the fluid.

2. 10. The antiseptic cap of claim 1, wherein the umbrella stopper further comprises a rounded or chamfered end, the rounded or chamfered end configured to fluidly occlude the hub of the luer connector.

3. 2. The antiseptic cap of claim 1, wherein the fan-shaped barrier is at a right angle to the stem.

4. 2. The antiseptic cap of claim 1, wherein the fan-shaped barrier is at an obtuse angle relative to the stem.

5. 1. An antiseptic cap having a housing, The upper wall and a cylindrical sidewall having an inner surface defining a cavity; an open bottom formed by a cylindrical sidewall with an opening to the cavity in the housing for receiving the hub of a luer connector; a closure structure disposed within the cavity, the closure structure configured as a plurality of hydrophilic bristles, the hydrophilic bristles disposed on the top wall of the housing, the hydrophilic bristles fluidly occluding the hub of the luer connector; and a fluid retained within the hydrophilic bristles and releasable when the hub of the luer connector is received within the interior surface of the cavity; A disinfection cap comprising:

6. 6. The antiseptic cap of claim 5, further comprising a movable conical stopper, the movable conical stopper including an upper portion and a lower portion, the upper portion including a flange having a diameter smaller than a diameter of the cavity, the upper portion including a lumen extending therethrough, the cavity including the protrusion configured as a secondary closure structure that occludes the hub of the luer connector.

7. 1. An antiseptic cap having a housing, an upper portion including a set of wing-like projections configured to receive a membrane or pouch, the membrane or pouch including a bulbous cavity for holding a fluid, the fluid pathway fluidly connecting the bulbous cavity to a drain; a drain disposed on an upper surface of the upper portion, the drain including a conical cavity having a lumen disposed on a lower surface of the conical cavity, the lumen being in fluid communication with a cavity defined by an inner surface of the lower portion of the housing; at least two bones extending from the top surface to the center of the conical cavity, the at least two bones configured to secure protrusions disposed within the cavity, the protrusions extending through the lumen, the protrusions configured as a closure structure by a lower portion of the antiseptic cap having a diameter equal to or greater than a diameter of a hub of a medical device; an open bottom formed by a cylindrical sidewall of the cavity, the open bottom providing an opening to the cavity within the housing, the open bottom receiving the hub of a luer connector when the hub is received within an inner surface of the cavity; A disinfection cap comprising:

8. 1. An antiseptic cap having a housing, a cylindrical housing upper portion having an engagement surface disposed around a periphery of an upper surface of the upper portion, the engagement surface configured to receive a membrane or pouch, the membrane or pouch having a dome shape defining a bulbous cavity for holding a fluid; a base formed by a cylindrical sidewall with an opening to a cavity in the base for receiving the hub of a luer connector; at least two vent holes or slits disposed through the top surface of the top portion, the at least two vent holes or slits fluidly communicating with the bulbous cavity of the top portion and a cavity in the bottom portion, the at least two vent holes being disposed a distance from one another, the distance being greater than a width of a lumen of the hub of the Luer connector; The hub of the Luer connector is received within the inner surface of the bulbous cavity, and the bulbous cavity can be pressed or collapsed against the top surface, thereby releasing fluid into the at least two vent holes or slits.

9. 9. The antiseptic cap of claim 8, wherein the hub of the luer connector abuts against an upper wall of a cavity in the base, the upper wall fluidly sealing the hub of the luer connector.

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