Sterile cap

Abstract

A disinfecting cap is described for connection to a medical connector. The disinfecting cap includes a housing having a top wall and a sidewall forming a cavity, a plug feature disposed on the top wall of the cavity for fluidically plugging a hub of a luer connector, and a disinfectant or antimicrobial disposed within an open cell foam structure within the cavity. The open cell foam structure releases the disinfectant or antimicrobial when depressed by the hub of the luer connector.

Description

Technical Field

[0001] This disclosure relates to a sterilization cap device for sterilizing corresponding medical connectors. Generally, this disclosure relates to devices for sterilizing and disinfecting access ports of medical connectors with fittings. Typically, exemplary embodiments of this disclosure relate to the field of threaded or interlocking fittings, including medical caps and medical sterilization caps, particularly caps and / or sterilization caps used with threaded fluid connectors. One or more exemplary embodiments of this disclosure relate to a male sterilization cap device for sterilizing threaded male Luer connectors. Background Technology

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally classified into two types: peripheral catheters and central venous catheters. When a hub, port, or valve is connected to a VAD to deliver fluids or medications, bacteria and other microorganisms can enter the patient's vascular system through the hub, port, or valve. Each hub, port, valve, or connection is associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal. To reduce CRBSI occurrences and ensure the proper use and maintenance of VADs, practice standards, including disinfection and cleaning procedures, have been developed. Sterilization caps have been added to the guidelines of the Society for Health Care Epidemiology (SHEA) and the Infusion Nurse Standards (INS) guidelines.

[0003] In developed markets, when using IV catheters, needleless connectors are typically used to close the system before it is subsequently inserted into the patient for medication administration or other necessary fluids. INS Practice Standards recommend the use of needleless connectors, stating that “they should be consistently and thoroughly disinfected with alcohol, iodine, or a chlorhexidine gluconate / alcohol mixture prior to each insertion.” Disinfection of needleless connectors ultimately aims to help reduce bacteria that can be present on the surface and may contribute to various catheter-related complications, including CRBSI. Nurses typically perform this disinfection task using 70% isopropyl alcohol (IPA) wipes through a procedure known as “scrubbing the hub.” However, compliance with this practice is generally low. In addition to the lack of compliance with “scrubbing the hub,” interviews with clinicians have revealed discrepancies in scrubbing time, drying time, and the number of times the needleless connector is scrubbed.

[0004] The need to protect male and female Luer connectors to reduce central line-associated bloodstream infections (CLABSI) and peripheral line-associated bloodstream infections (PLABSI) is increasing. Without proper protection, intravenous gravity fittings on syringes and threaded male Luer connectors can become contaminated. Currently, when IV connectors are disconnected from central or peripheral lines to temporarily interrupt infusion, nurses typically wrap the male Luer connector around a Y-type needleless connector or wrap it in a wet wipe or cloth soaked in isopropyl alcohol (“IPA”). However, this protection is weak and fails to adequately protect the Luer connector from contact contamination. Sterilization caps have become state-of-the-art sterilization and protection devices used to sterilize male Luer connectors and create a physical barrier against microbial growth.

[0005] Throughout the series of procedures associated with the spread of microorganisms that can lead to CRBSI, there are numerous risks of contact or contamination. For example, contamination can occur during drug mixing, cannula attachment, and insertion into the access hub. Furthermore, threaded male Luer connectors have open Luer fittings with exposed lumens. Because the procedure for connecting a VAD is so common and simple, the risks associated with accessing the patient's vascular system are often overlooked. Currently, the risks to hospitals and patients depend primarily on the level of care of the clinician performing the connection, and this level of care is largely uncontrollable.

[0006] Because disinfectants are biotoxic at high doses, they typically have threshold limits for systemic exposure when infused into the bloodstream. Therefore, a disinfection device is needed that can block the lumen of an open Luer connector to mitigate the entry of the disinfectant into the connector, thereby reducing the risk of disinfectant entering the bloodstream. A mechanism is needed that provides effective disinfection of surrounding connectors or fittings while preventing disinfectant from entering the lumen and fluid pathways. Summary of the Invention

[0007] A first aspect of this disclosure relates to a sterilization cap having a housing comprising: a top wall; cylindrical sidewalls; and an open bottom formed by the cylindrical sidewalls. The cylindrical sidewalls have an inner surface defining a cavity. The open bottom has an opening leading to the cavity for receiving a hub of a Luer connector.

[0008] A blocking feature is disposed within the cavity. The blocking feature is configured as a cylindrical protrusion disposed on the top wall of the housing. The cylindrical protrusion fluidly blocks the hub of the Luer connector. Fluid releasably retained within a compressible 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 substantially 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 non-removably disposed on the top wall of the housing.

[0011] In one or more embodiments, the open-cell foam structure is disposed against a top wall. In one or more embodiments, the open-cell foam structure has a hollow cylindrical shape configured to fit around a 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 that of the top wall and the lower portion having a smaller diameter than that of the upper portion, the lower portion being configured to fluidly block the hub of the Luer joint.

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

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

[0015] In one or more embodiments, the sterilization cap further includes at least one thread on the outer surface of the housing. The at least one thread is sufficient to interlock with the mating features of a Luer connector.

[0016] In one or more embodiments, the hub is secured within the inner surface of the cavity by interlocking at least a portion of the at least one thread with a mating feature on the hub of the Luer connector.

[0017] In one or more embodiments, the inner surface of the cavity is fixed 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: isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof.

[0019] A second aspect of this disclosure relates to a sterilization cap having a housing comprising: a top wall having an orifice partially extending into the housing; a cylindrical sidewall having an inner surface defining a cavity; and an open bottom formed by the cylindrical sidewall having an opening leading to a cavity within the housing for receiving a hub of a Luer connector. An umbrella-shaped plug includes a rod at least partially disposed within the orifice of the top wall. The umbrella-shaped plug also includes a fan-shaped barrier configured to fluidly block a blocking feature of the hub of a medical device. The fan-shaped barrier forms a liquid-tight seal with the inner surface of the sidewall. Fluid is releasably retained within the cavity of the umbrella-shaped plug and the fan-shaped barrier. The hub of the Luer connector is received within the inner surface of the cavity. Fluid is released when the fan-shaped barrier deforms upon movement against the hub.

[0020] In one or more embodiments, the umbrella-shaped plug further includes a rounded or chamfered end configured to fluidly block the hub of the Luer connector. In one or more embodiments, the sector barrier is perpendicular to the rod. In one or more embodiments, the sector barrier is at an obtuse angle to the rod.

[0021] A third aspect of this disclosure relates to a sterilization cap having a housing comprising: a top wall; cylindrical sidewalls having an inner surface defining a cavity; and an open bottom formed by the cylindrical sidewalls, the open bottom having an opening into the cavity within the housing for receiving a hub of a Luer connector. A plugging feature is disposed within the cavity, the plugging feature being configured as a plurality of hydrophilic bristles. The hydrophilic bristles are disposed on the top wall of the housing, the hydrophilic bristles fluidly plugging the hub of the Luer connector; and the fluid is releasably retained within the hydrophilic bristles. The hub of the Luer connector is received within the inner surface of the cavity.

[0022] In one or more embodiments, the sterilization cap further includes a movable conical plug comprising a top portion and a bottom portion, the top portion including a flange with a diameter smaller than the diameter of the cavity. The top portion also includes an inner cavity extending therethrough. The cavity includes a protrusion configured as a secondary blocking feature, through which the protrusion blocks the hub of the Luer connector.

[0023] A fourth aspect of this disclosure relates to a sterilization cap having a housing comprising a top portion including a set of winged protrusions configured to receive a membrane or bag, the membrane or bag including a spherical cavity for retaining fluid and a fluid path for fluidly connecting the spherical cavity to an outlet. The outlet is disposed on a top surface of the top portion and includes a conical cavity having an inner cavity disposed on a bottom surface of the conical cavity. The inner cavity is in fluid communication with a cavity defined by an inner sidewall of a bottom portion of the housing. At least two spikes extend from the top surface to the center of the conical cavity, the at least two spikes being structurally fixed to protrusions within the cavity extending through the inner cavity. The protrusions are configured as a blocking feature, through which the diameter of the lower portion is equal to or greater than the diameter of the hub of a medical device. An open bottom is formed by the cylindrical sidewalls of the cavity, having an opening leading to 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 inner surface of the cavity.

[0025] A fifth aspect of this disclosure relates to a sterilization cap having a housing comprising an upper portion and an open bottom. The upper portion has a circumferentially disposed engagement surface surrounding a top surface of the upper portion. The engagement surface is configured to receive a membrane or pouch having a dome shape defining a spherical cavity for retaining fluid. The open bottom is formed by cylindrical sidewalls of the cavity and has an opening leading to the cavity for receiving a hub of a Luer connector. At least two outlets or slits are disposed through the top surface of the upper portion, the at least two outlets or slits being in fluid communication with the spherical cavity of the upper portion and the cavity. The hub of the Luer connector is received within an inner surface of the cavity. The spherical cavity can be depressed or collapsed onto the top surface of the upper portion, thereby releasing fluid into the at least two outlets or slits.

[0026] In one or more embodiments, the hub of the Luer connector abuts the top wall of the cavity, which fluid-seales the hub of the Luer connector. Attached Figure Description

[0027] Figure 1 A perspective view of a disinfection cap according to an exemplary first embodiment of the present disclosure is shown;

[0028] Figure 2 A cross-sectional view of the disinfection cap according to the first embodiment of the present disclosure along axis X-X' is shown;

[0029] Figure 3A A perspective view of a threaded connector according to a first embodiment of the present disclosure is shown;

[0030] Figure 3B A perspective view of a threaded connector along axis Y-Y' according to a first embodiment of the present disclosure is shown;

[0031] Figure 4A A perspective view of a disinfection cap according to a first embodiment of the present disclosure is shown;

[0032] Figure 4B A perspective view of a disinfection cap according to a first embodiment of the present disclosure along axis Z-Z' is shown;

[0033] Figure 5A A cross-sectional view of a disinfection cap according to a second embodiment of the present disclosure is shown;

[0034] Figure 5B An exploded cross-sectional view of a disinfection cap according to a second embodiment of the present disclosure is shown;

[0035] Figure 6 A cross-sectional view of a disinfection cap according to a third embodiment of the present disclosure is shown;

[0036] Figure 7A A cross-sectional view of a disinfection cap according to a fourth embodiment of the present disclosure is shown;

[0037] Figure 7B A cross-sectional view of a disinfection cap according to a fourth embodiment of the present disclosure is shown;

[0038] Figure 8A A cross-sectional view of a disinfection cap according to a fifth embodiment of the present disclosure is shown;

[0039] Figure 8B A cross-sectional view of a disinfection cap according to a fifth embodiment of the present disclosure is shown;

[0040] Figure 9 A cross-sectional view of a disinfection cap according to a sixth embodiment of the present disclosure is shown;

[0041] Figure 10A A cross-sectional view of a disinfection cap according to a sixth embodiment of the present disclosure is shown;

[0042] Figure 10B A cross-sectional view of a disinfection cap according to a sixth embodiment of the present disclosure is shown; and

[0043] Figure 11 A cross-sectional view of a disinfection cap according to a seventh embodiment of the present disclosure is shown. Detailed Implementation

[0044] Embodiments of this disclosure relate to a sterilization cap for connecting to and sterilizing a medical connector, including a threaded connector. In one or more embodiments, the medical connector is a pinless connector or a Luer connector. This disclosure aims to provide a mechanism that prevents disinfectant from entering the fluid path of the medical connector while providing effective sterilization of the hub and surrounding periphery of the medical connector.

[0045] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the structures or processing steps set forth in the following description. This disclosure can have other embodiments and can be practiced or implemented in various ways.

[0046] For the purposes of description below, the terms “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and their derivatives, when oriented in the accompanying drawings, shall be used in connection with this disclosure. However, it should be understood that alternative variations and sequences of steps may be taken in this disclosure unless explicitly stated otherwise. It should also be understood that the specific devices and processes shown in the accompanying drawings and described in the following specification are merely exemplary embodiments of this disclosure. Therefore, specific dimensions and other physical characteristics relating to the embodiments disclosed herein should not be considered limiting.

[0047] As used herein, the terms “an,” “a,” and “the / that” include both singular and plural forms.

[0048] 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.

[0049] As used herein, the term "Luer connector" refers to a connecting collar, a standard method of attaching syringes, catheters, hubed needles, IV tubing, etc., to each other. A Luer connector consists of interlocking tubes that are slightly tapered so that they can be joined together with a simple pressure / torsion fit. Luer connectors may optionally include additional external threaded edges for added strength. The ends of a Luer connector are typically associated with a flushing syringe and are interlocked and connected to the end located on a vascular access device (VAD). A Luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, and a formed central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The Luer connector also has a distal channel for releasably attaching the Luer connector to the hub of the VAD and a proximal channel for releasably attaching the Luer connector to the barrel of the syringe. As used herein, the term "Luer connector" refers to either a Luer connector or a female Luer connector.

[0050] As used herein, the term "medical device" refers to a general medical device having a threaded or interlocking connection with corresponding mating elements. By way of example and not limitation, a syringe may have a threaded connection that is releasably interlocked with a secondary medical device (e.g., a catheter, IV line, or a Luer connector such as a catheter). The threaded connection may include an inner lumen defining a fluid path surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0051] As will be readily understood by those skilled in the art, while descriptive terms such as “thread,” “taper,” “plate,” “wall,” “top,” “side,” “bottom,” etc., are used throughout the specification for ease of understanding, they are not intended to limit any components that can be used in combination or alone to implement various aspects of the embodiments of this disclosure.

[0052] Embodiments of the disinfection cap disclosed herein include a housing having: a top wall defining a closed end; a generally cylindrical sidewall having an inner surface defining a cavity; an open end formed by the cylindrical sidewall having an opening leading to the cavity within the housing for receiving a hub with a threaded connection, at least one thread on the outer surface of the cylindrical sidewall being sufficient to interlock with a mating feature of the threaded connection; a plugging feature disposed within the cavity; and a disinfectant or antibacterial agent retained within the cavity. Embodiments of the disinfection cap disclose at least one thread of the mating feature of the threaded connection (more specifically, a Luer connector connection) of the disinfection cap. The plugging feature is configured to prevent the disinfectant from entering the fluid path of the hub of the Luer connector connection. In one or more embodiments, the outer surface of the housing at the open end of the disinfection cap includes a peripheral wall extending radially outward from the open end, defining an end face and a mating surface for a peelable seal and / or diaphragm to maintain the sterility of the cavity. The peelable seal reduces or prevents contamination of the cavity during transport and storage of the disinfection cap. The removable seal is typically held in the closed position until just before the injection and / or aspiration procedure, at which point it is removed. The removable seal minimizes the entry of potential particulate hazards and provides a substantially impermeable shell for the cavity before the use of a sterilization cap. The movable seal provides adequate sealing within a range of temperature, pressure, and humidity conditions.

[0053] The sterilization cap provides a mechanical barrier for the connector and contains a disinfectant or antibacterial agent (hereinafter referred to as the "fluid"). The sterilization cap of this disclosure allows practicing physicians to streamline the sterilization process. The exemplary embodiments illustrated in this specification are provided to aid in a comprehensive understanding of this disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of this disclosure. Furthermore, for clarity and brevity, descriptions of well-known functions and constructions have been omitted.

[0054] Specifically, a licensed physician can sterilize a Luer connector with a single action by inserting or screwing a sterilizing cap onto the Luer connector of the medical device. This causes a blocking feature to prevent fluid from entering the fluid path of the Luer connector, while the hub of the Luer connector simultaneously releases the fluid, allowing sterilization of the hub and its periphery. The sterilizing cap can then be removed by removing or loosening it from the Luer connector of the medical device and then inserting or screwing it onto the Luer connector (e.g., a Y-shaped connector or a Luer connector).

[0055] In exemplary embodiments of this disclosure, the sterilization cap includes integrated threads or tabs and other features combined in any and all ways to allow it to mate with threaded fittings of medical devices. In a preferred embodiment, the sterilization cap mates with a Luer connector fitting. Exemplary constructions of connectors, fittings, ports, and adapters may include commercially available Luer connector locks, Luer connector slide ports, locking ports, threaded connectors, interlocking connectors, or other commonly known medical device fittings in the art.

[0056] Referring now to the accompanying drawings, in which the same reference numerals throughout several views denote the same or corresponding parts, embodiments of the present disclosure are described below.

[0057] like Figure 1 and Figure 2 As shown, a first aspect of this disclosure relates to a sterilizing cap 100, which includes 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, having a cylindrical housing 112. In other embodiments, the lower portion 110B may have a tapered lower portion. The upper portion 110A of the housing has inwardly tapered sidewalls. In other 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, the cavity 130 being open at a bottom 116 for receiving a hub of a Luer connector. In one embodiment, the upper portion 110A and the lower portion 110B are integrally formed, while in other embodiments, they are assembled non-removably or removably using threaded fasteners, press-fit fasteners, adhesive fasteners, or combinations thereof.

[0058] In one or more embodiments, the cavity 130 can be configured to facilitate a loose fit between the cavity 130 and the hub of the Luer connector, wherein the sterilization cap 100 is secured by at least one thread 122 or at least a set of tabs included on the outer surface of the cylindrical housing 112. The at least one thread 122 provided on the outer surface of the cylindrical housing 112 is sized and has a thread pattern that engages with standard ISO-2 type fittings. The loose fit allows fluid to flow around the hub of the Luer connector. In other embodiments, the cavity 130 can be configured as a Luer sliding fitting to facilitate an interference fit between the cavity 130 and the hub of the Luer connector. The interference fit can be configured to be strong enough that no threaded fastener or the at least one thread 122 is required when the cavity 130 is removably secured to the Luer connector.

[0059] In one or more embodiments, when the hub of the Luer connector is received within the inner surface 126 of the cavity 130, the hub is secured within the cavity 130 of the sterilization cap 100 by interlocking at least a portion of the at least one thread 122 with a mating feature on the hub of the Luer connector. In one or more embodiments, the at least one thread 122 may include a beveled thread pattern. In one or more embodiments, the at least one thread 122 may include a helical thread pattern. Such connectors are generally and typically used in medical applications as catheters and other liquid-tight protection connectors. In some embodiments, the sterilization cap 100 provides a protective cover for the Luer connector when engaged with the connector, as the threads from the Luer connector engage at least one thread 122 of the sterilization cap 100 and form a releasable connection thereto.

[0060] Figure 2 The disinfection cap 100 is depicted Figure 1 The cross-sectional view of the X-X' plane is shown. Figure 2 As shown, the cavity 130 of the housing 110 extends from the open bottom 116 to the top wall 114, representing a length L of the total length of the housing 110. C The cavity 130 has a substantially cylindrical shape. A protrusion 118 extends from the top wall 114 and is configured as a blocking feature for an inner cavity extending through the hub of the Luer connector of the medical device. In a preferred embodiment, the protrusion 118 has a substantially cylindrical shape and is uniformly connected to the top wall 114. The diameter of the protrusion 118 is sized and configured to fluidly block the inner cavity of the Luer connector. In one or more embodiments, the protrusion 118 has a substantially tapered shape. In one or more embodiments, the end 124 of the protrusion 118 is rounded or chamfered to facilitate insertion of the protrusion 118 into the inner cavity of the Luer connector.

[0061] An open-cell foam structure 120 for absorbing and retaining fluid may be disposed against a top wall 114. In a preferred embodiment, the open-cell foam structure 120 has a hollow cylindrical shape and is configured to fit around the protrusion 118 without extending beyond the protrusion 118. The open-cell foam structure 120 is compressible in both the horizontal and vertical directions, thereby allowing the open-cell foam structure 120 to form an interference fit with the inner surface 126 of the cavity 130. When the open-cell foam structure 120 is compressed, the open-cell foam allows fluid to be discharged. When the sterilization cap 100 is screwed or pushed against the Luer connector, the inner cavity of the Luer connector is fluid-sealed and blocked by the protrusion 118, while the hub of the Luer connector compresses the open-cell foam structure 120, thereby releasing the fluid used to sterilize the hub and periphery of the Luer connector. In a preferred embodiment, the open-cell foam structure 120 may be neoprene, polyurethane, natural rubber, or a medical-grade open-cell foam suitable for sterilization with a low or zero cytotoxicity rating.

[0062] exist Figure 3A and Figure 3B An exemplary Luer connector 170 is depicted, wherein Figure 3A A cross section along the plane Y-Y' is shown. The Luer connector 170 includes an inner cavity 172 disposed through a hub 174 having a tapered surface, a mating feature having at least one thread 176, and a mating surface 178 disposed at the bottom of the hub 174. Figure 4A and Figure 4B A sterilization cap 100 is depicted that is fully inserted into a Luer connector 170, wherein Figure 4B A cross-section along plane Z-Z' is shown. As shown, at least one thread 122 of the sterilization cap 100 is fully engaged and releasably secured to at least one thread 176 of the Luer connector 170. In this position, the mating surface of the sterilization cap 100 abuts the mating surface 178 of the Luer connector 170. In this position, the hub 174 is fully depressed against the open-cell foam structure 120, thereby releasing and sterilizing the fluid contained in and around the hub 174 of the Luer connector 170, while the protrusion 118 of the sterilization cap 100 fluid-seales the inner cavity 172 of the Luer connector 170, thereby preventing fluid from entering the fluid path of the inner cavity 172 of the Luer connector 170.

[0063] Other embodiments of the sterilization cap are envisioned to have alternative clogging features. An exemplary sterilization cap includes a housing having an upper and a lower portion. In one or more embodiments, the lower portion of the sidewalls is substantially cylindrical, forming a cylindrical housing, while other embodiments may have a conical housing. The upper portion of the housing has inwardly tapered sidewalls, while other embodiments have substantially cylindrical sidewalls. 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.

[0064] In one or more embodiments, the exemplary cavity may be configured to facilitate a loose fit between the cavity and the hub of the Luer connector, wherein the exemplary sterilization cap is secured by at least one thread or at least one set of tabs included on the outer surface of the cylindrical housing. The loose fit allows fluid to flow around the hub of the Luer connector. In other embodiments, the exemplary cavity may be configured in a Luer sliding connection to facilitate an interference fit between the cavity and the hub of the Luer connector. The interference fit may be configured to be sufficiently robust to eliminate the need for threaded fasteners or at least one thread when the cavity is removably secured to the Luer connector.

[0065] In one or more embodiments, when the hub of the Luer connector is received within the inner surface of the cavity, the hub is secured within the cavity of the sterilization cap by interlocking at least a portion of at least one thread with a mating feature on the hub of the Luer connector. In one or more embodiments, the at least one thread may include a beveled thread pattern. In one or more embodiments, the at least one thread may include a helical thread pattern. Such connectors are generally and typically used in medical applications as connectors for catheters and other fluid-tight protection. In some embodiments, the sterilization cap provides a protective cover for the Luer connector when engaged with the connector, as the thread from the Luer connector engages at least one thread of the sterilization cap and forms a releasable connection thereto.

[0066] Figure 5A and Figure 5B An exemplary disinfection cap 200 according to a second embodiment of the present disclosure is depicted, wherein Figure 5B An exploded view of an exemplary sterilization cap 200 is depicted, and Figure 5A Figure 5B depicts a cross-section. The sterilization cap 200 includes a housing 210 having a lower portion, wherein the inner surface 226 of the lower portion of the housing 210 defines a cavity 230 having an open bottom 216 for receiving a hub of a Luer connector.

[0067] The cavity 230 of the housing 210 extends from the open bottom 216 to the top wall 214, representing a length L of the total length of the housing 210. C The cavity 230 has a generally cylindrical shape. A plug 218 is adjacent to the top wall 214 and is configured to provide a blocking feature for the inner cavity that extends through the hub of the Luer connector of the medical device.

[0068] In a preferred embodiment, the plug 218 has a generally cylindrical shape, having an upper portion 228 and a lower portion 223 integrally formed. The diameter of the upper portion 228 is equal to or greater than that of the top wall 214, thereby forming an interference fit that removably retains the plug within the cavity 230. The diameter of the lower portion 223 of the plug 218 is sized and configured to fluidly block the cavity of the Luer connector. In one or more embodiments, the lower portion 223 has a generally tapered shape. In one or more embodiments, the end 224 of the lower portion 223 is rounded or chamfered to facilitate insertion of the lower portion 223 into the cavity of the Luer connector. The diameter of the upper portion 228 is greater than that of the lower portion 223. In a preferred embodiment, the plug 218 is bonded to the top wall 214 of the cavity 230 of the sterilization cap 200 by an interference fit, a medical-grade adhesive fit, or a combination thereof. The plug 218 may be made of rubber, TPE, or plastic.

[0069] An open-cell foam structure 220 for absorbing and retaining fluid may be disposed against the bottom surface of the upper portion 228 of the plug 218. In a preferred embodiment, the open-cell foam structure 220 has a hollow cylindrical shape and is configured to fit around the lower portion 223 of the plug 218 without extending beyond the lower portion 223. The open-cell foam structure 220 is compressible in both horizontal and vertical directions, thereby allowing the open-cell foam structure 220 to form an interference fit with the inner surface 226 of the cavity 230. When the open-cell foam structure 220 is compressed, it allows fluid to be expelled. When the sterilization cap 200 is screwed or pushed against the Luer connector, the inner cavity of the Luer connector is sealed and blocked by the plug 218, while the hub of the Luer connector compresses the open-cell foam structure 220, thereby releasing the fluid sterilizing the hub and periphery of the Luer connector. In a preferred embodiment, the open-cell foam structure 220 may be chloroprene rubber, polyurethane, natural rubber, or a medical-grade open-cell foam suitable for sterilization with low or zero cytotoxicity.

[0070] Figure 6 An exemplary sterilization cap 300 according to a third embodiment of the present disclosure is depicted. The sterilization 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 defining a cavity 330 having an open bottom 316 for receiving a hub of a Luer connector. The upper portion 304 of the sterilization cap 300 has a larger diameter than the lower portion 306, and the upper portion 304 serves as a gripping surface for a physician to manipulate the sterilization cap 300. In one embodiment, the upper portion 304 is integrally formed with the sterilization cap 300, while in other embodiments, it is non-removably or removably assembled using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof.

[0071] The cavity 330 of the housing 310 extends from the open bottom 316 to the top wall 314, representing a length L of the total length of the housing 310. C The cavity 330 has a substantially cylindrical shape. The first open-cell foam structure 319 for absorbing and retaining fluid has a substantially cylindrical shape adjacent to the top wall 314.

[0072] A plug 318 abuts the bottom surface of the first open-cell foam structure 319. The plug 318 is configured to provide a blocking feature for a cavity 372 extending through the hub 374 of the Luer connector 370 of the medical device. In a preferred embodiment, the plug 318 has a substantially cylindrical shape, having an upper portion 328 and a lower portion 323 integrally formed. The upper portion 328 has a diameter equal to or greater than that of the top wall 314, thereby forming an interference fit that removably retains the plug within the cavity 330. The diameter of the lower portion 323 of the plug 318 is sized and configured to fluidly block the cavity of the Luer connector. In one or more embodiments, the lower portion 323 may have a substantially tapered shape. In one or more embodiments, the end 324 of the lower portion 323 may be rounded or chamfered to facilitate insertion of the lower portion 323 into the cavity of the Luer connector. The diameter of the upper part 328 is larger than the diameter of the lower part 323, and the diameter of the upper part 328 is smaller than the diameter of the first open-cell foam structure 319.

[0073] A second open-cell foam structure 320 for absorbing and retaining fluid may be adjacent to the bottom surface of the first open-cell foam structure 319. In a preferred embodiment, the open-cell foam structure 320 has a hollow cylindrical shape and is configured to fit around the lower portion 323 of the plug 318 without extending 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.

[0074] The first open-cell foam structure 319 and the second open-cell foam structure 320 are compressible in both the horizontal and vertical directions, thereby allowing them to form an interference fit with the inner surface 326 of the cavity 330. When the first open-cell foam structure 319 and the second open-cell foam structure 320 are compressed, fluid is allowed to be discharged. When the sterilization cap 300 is screwed or pushed against the Luer connector, the inner cavity of the Luer connector is fluid-sealed and blocked by the plug 318, while the hub of the Luer connector compresses the first open-cell foam structure 319 and the second open-cell foam structure 320, thereby releasing the fluid used for sterilization of the hub and periphery of the Luer connector. In a preferred embodiment, the first open-cell foam structure 319 and the second open-cell foam structure 320 may be neoprene, EPDM, Viton, polyurethane, natural rubber, or a medical-grade open-cell foam suitable for sterilization with low or zero cytotoxicity.

[0075] Figure 7A and Figure 7B An exemplary sterilization cap 400 according to a fourth embodiment of the present disclosure is depicted. The sterilization cap 400 includes a housing 410 having an upper portion 404, a lower portion 406, and an inner surface 426 of the lower portion of the housing 410 defining a cavity 430 having an open bottom 416 for receiving a hub of a Luer connector. The upper portion 404 of the sterilization cap 400 has a larger diameter than the lower portion 406, and the upper portion 404 serves as a gripping surface for a physician to manipulate the sterilization cap 400. In one embodiment, the upper portion 404 is integrally formed with the lower portion 406, while in other embodiments, it is non-removably or removably assembled using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof.

[0076] The cavity 430 of the housing 410 extends from the open bottom 416 to the top wall 414, representing the length L of the total length of the housing 410. C The cavity 430 has a generally cylindrical shape. The top wall 414 also includes an aperture 415, which extends for a length L. A It extends into the housing 410. The orifice 415 extends toward the upper part 404.

[0077] The rod 428 of the umbrella-shaped plug 418 is at least partially disposed within the orifice 415. The rod 428 may be integrally formed within the orifice 415. In one or more embodiments, the rod 428 may be assembled non-removably or removably using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof. The umbrella-shaped plug 418 also includes a sector barrier 427, wherein the umbrella-shaped plug 418 and more specifically the sector barrier 427 are configured as a blocking feature for a cavity 472 extending through the hub 474 of the Luer connector 470 of the medical device. The sector barrier 427 of the umbrella-shaped plug 418 forms a liquid-tight seal with the inner surface 426 of the cavity 430. The diameter of the sector barrier 427 is substantially equal to the diameter of the cavity 430. In one or more embodiments, the end 424 of the rod 428 may be rounded or chamfered to facilitate insertion of the rod 428 into the cavity 472 of the Luer connector 470.

[0078] Fluid is disposed within the cavity defined by the sector barrier 427 and the upper portion of the cavity 430. When the sterilization cap 400 is screwed or pushed against the Luer connector, the sector barrier 427 elastically deforms into the inner cavity 472, thereby breaking the liquid-tight seal between the sector barrier 427 and the cavity 430 while simultaneously forming a liquid-tight seal, thus releasing the fluid used for sterilizing the hub and periphery of the Luer connector. In a preferred embodiment, the sector barrier 427 may be made of a deformable elastomer material such as rubber or TPE.

[0079] Figure 8A and Figure 8B An exemplary sterilization cap 500 according to a fifth embodiment of the present disclosure is depicted. The sterilization 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 defining a cavity 530 having an open bottom 516 for receiving a hub of a Luer connector. The upper portion 504 of the sterilization cap 500 has a larger diameter than the lower portion 506, and the upper portion 504 serves as a gripping surface for a physician to manipulate the sterilization cap 500. In one embodiment, the upper portion 504 is integrally formed with the lower portion 506, while in other embodiments, it may be non-removably or removably assembled using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof.

[0080] The cavity 530 of the housing 510 extends from the open bottom 516 to the top wall 514, representing a length L of the total length of the housing 510. C The cavity 530 has a generally cylindrical shape. The top wall 514 also includes an aperture 515, which extends for a length L. AThe rod 528 of the umbrella-shaped plug 518 is at least partially disposed in the orifice 515. The rod 528 may be integrally formed in the orifice 515, while in other embodiments, the rod 528 may be assembled non-removably or removably using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof.

[0081] The umbrella-shaped plug 518 also includes a fan-shaped barrier 527, which, along with the more specific fan-shaped barrier 527, is configured as a blocking element for a cavity 572 extending through the hub 574 of the Luer connector 570 of the medical device. Figure 8A In the initial position shown, the fan-shaped barrier 527 of the umbrella-shaped plug 518 forms a liquid-tight seal with the inner surface 526 of the cavity 530. The fan-shaped barrier 527 has a substantially conical shape, and its edges are configured to surround part of the hub 574. The fan-shaped barrier 527 includes a plurality of spikes 529 arranged radially from the rod 528, which help maintain the conical structure of the fan-shaped barrier 527.

[0082] The fluid is contained within a chamber defined by the sector barrier 527 and the upper part of the cavity 530. For example... Figure 8B As shown, when the sterilization cap 500 is screwed or pushed against the Luer connector to its final position, the sector barrier 527 elastically deforms into the inner cavity 572. This elastic deformation of the sector barrier 527 interrupts the liquid-tight seal between the sector barrier 527 and the cavity 530, while simultaneously forming a liquid-tight seal, thereby releasing the fluid used for sterilizing the hub and periphery of the Luer connector. In a preferred embodiment, the sector barrier 527 may be made of a deformable elastomer material such as rubber or TPE.

[0083] Figure 9 An exemplary sterilization cap 600 according to a sixth embodiment of the present disclosure is depicted. The sterilization 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 defining a cavity 630 having an open bottom 616 for receiving a hub of a Luer connector. The upper portion of the sterilization cap 600 has a larger diameter than the lower portion, and this upper portion serves as a gripping surface for a physician to manipulate the sterilization cap 600. In one embodiment, the upper and lower portions are integrally formed, while in other embodiments, they are non-removably or removably assembled using threaded connectors, press-fit connectors, adhesive connectors, or combinations thereof.

[0084] The cavity 630 of the housing 610 extends from the open bottom 616 to the top wall 614, representing a length L of the total length of the housing 610. CThe cavity 630 has a substantially cylindrical shape. Multiple hydrophilic bristles 618 extend from the top wall 614, the distance of which is less than the total length of the cavity 630. The hydrophilic bristles 618 retain fluid. By preventing fluid from flowing into the inner cavity 672 of the hub 674 extending through the Luer connector 670 of the medical device, the hydrophilic bristles 618 elastically deform upon abutting or pushing the sterilization cap 600 against the Luer connector, thereby blocking the inner cavity 672. The hydrophilic bristles 618 are initially bound during initial engagement, and upon pushing the hub 674, the hydrophilic bristles 618 are compressed into the opening of the inner cavity 672 to prevent further sterilization from flowing in. Sterilization adsorbed on the portion of the bristles is squeezed into the surrounding bristle space to be distributed to the outer inner cavity surface.

[0085] Figure 10A and Figure 10B An exemplary sterilization cap 600 according to a sixth embodiment of this disclosure is depicted. The sterilization 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 defining a cavity 630 having an open bottom 616 for receiving a hub of a Luer connector. The upper portion of the sterilization cap 600 includes a set of winged protrusions 640 configured to receive a membrane or pouch 642. The membrane or pouch 642 is secured to the winged protrusions 640 using a medical-grade adhesive. The set of winged protrusions 640 can serve as a gripping feature, thereby assisting a physician in twisting or inserting the sterilization cap 600 into or onto the Luer connector. The membrane or pouch 642 includes a spherical cavity 644 for retaining fluid 602. The spherical cavity 644 can be pressed down or collapsed onto itself by a practicing physician, thereby releasing fluid 602 into the discharge port 648 of the sterilization cap 600 through the fluid path 646. The discharge port 648 is located on the top surface 650 of the top of the sterilization cap 600. The cavity 630 of the housing 610 extends from the open bottom 616 to the top wall 614, representing a length L of the total length of the housing 610. C The cavity 630 has a basically cylindrical shape.

[0086] like Figure 10BAs shown, the discharge port 648 includes a conical cavity 652 in fluid communication with an inner cavity 654 disposed at the bottom of a conical cavity 652, the inner cavity 654 being in fluid communication with a cavity 630 of the housing 610. At least two spikes 656 extend from a top surface 650 into the center of the conical cavity 652. The at least two spikes 656 are configured to structurally secure a protrusion 658 extending into the conical cavity 652 and the inner cavity 654. The protrusion 658 includes a top and a bottom portion, the diameter of which is smaller than the diameter of the bottom portion. The diameter of the top portion is smaller than the diameter of the inner cavity 654 of the discharge port 648. The bottom portion of the protrusion 658 is configured as a blocking feature, through which the diameter of the bottom portion is equal to or greater than the diameter of the hub of the Luer connector of the medical device. When the sterilization cap 600 is screwed or pushed against the Luer connector, the lower part of the protrusion 658 fluid-seales the inner cavity of the hub of the Luer connector, thereby allowing the spherical cavity 644 to be pressed down or collapsed, thus releasing the fluid 602. The fluid 602 sterilizes the hub and periphery of the Luer connector.

[0087] Figure 11 An exemplary sterilization cap 700 according to a seventh embodiment of the present disclosure is depicted. The sterilization cap 700 includes a generally cylindrical housing 710 having an upper portion, a lower portion, and an inner surface 726 of the lower portion of the housing 710 defining a cavity 730 having an open bottom 716 for receiving a hub of a Luer connector. The upper portion of the sterilization cap 700 includes a mating surface 740 circumferentially disposed around a top surface 750 of the upper portion of the cylindrical housing 710. The mating surface 740 is configured to receive a membrane or pouch 742 having a dome shape defining a spherical cavity 744 for retaining fluid 702. The membrane or pouch 742 is secured to the mating surface 740 using a medical-grade adhesive. The physician can press or collapse the spherical cavity 744 onto the top surface 850 of the upper part of the cylindrical housing 710, thereby releasing fluid 702 into the cavity 730 of the lower part of the housing 710 via a fluid path. The fluid path is defined by at least two outlets or slits 748 provided through the top surface 750 of the upper part of the cylindrical housing 710. The slits facilitate fluid communication between the spherical cavity 744 and the cavity 730 of the lower part of the housing 710.

[0088] The cavity 730 of the housing 710 extends from the open bottom 716 to the top wall 714, representing a length L of the total length of the housing 710. C The cavity 730 has a substantially cylindrical shape. The length L of the total length of the housing 710 is... CThe length is substantially equal to that of the hub 774 of the Luer connector 770, wherein the top wall 714 is configured to serve as a blocking feature for the inner cavity 772 of the Luer connector 770. Upon abutment of the hub 774, the top wall 714 fluidly seals the inner cavity 772 of the Luer connector 770, thereby preventing fluid 702 from entering the inner cavity 772 when fluid 702 is ejected from the at least two slits 748. Similarly, the at least two slits 748 are positioned to be spaced apart from each other by a distance D. S The fluid 702 is thus ejected from at least two slits 748, thereby disinfecting the hub and periphery of the Luer connector.

[0089] When used in Luer connectors, sterilization is achieved by integrating fluids (102, 202, 302, 402, 502, 602, 702) into the cavities (130, 230, 330, 430, 530, 630, 730) of sterilization caps (100, 200, 300, 400, 500, 600, 700). The fluids (102, 202, 302, 402, 502, 602, 702) can be directly included within the cavities (130, 230, 330, 430, 530, 630, 730). The disinfection caps (100, 200, 300, 400, 500, 600, 700) are designed to be compatible with a variety of disinfectants or antimicrobial agents or fluids (102, 202, 302, 402, 502, 602, 702). In one or more embodiments, the disinfectant or antimicrobial agent or fluid (102, 202, 302, 402, 502, 602, 702) may include variants of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent or fluid (102, 202, 302) may include variants of alcohol or chlorhexidine.

[0090] In one or more embodiments, the fluids (102, 202, 302, 402, 502, 602, 702) are selected from the group consisting primarily of: isopropanol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexidine, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidine, antibiotics, and mixtures thereof. In one specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent (102, 202, 302, 402, 502, 602, 702) is a fluid or gel.

[0091] In one or more embodiments, the sterilization cap (100, 200, 300, 400, 500, 600, 700) may include a removable peel-back seal covering an opening leading to a cavity (130, 230, 330, 430, 530, 630, 730). In one or more embodiments, the peel-back seal includes a peel-back top of aluminum or a multilayer polymer film. In one specific embodiment, the peelable material is heat-sealed or induced-sealed to the open end of the sterilization cap (100, 200, 300, 400, 500, 600, 700). In one or more embodiments, the peel-back seal includes a moisture-proof layer.

[0092] The sterilization caps (100, 200, 300, 400, 500, 600, 700) are made of any of a variety 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 sterilization caps (100, 200, 300, 400, 500, 600, 700) comprise polypropylene or polyethylene material.

[0093] In one or more embodiments, the connector for the medical device may be selected from the group consisting essentially of: primary IV gravity kits, secondary IV gravity kits, extension kits, and needleless connectors on infusion or syringe pump kits, catheter Luer connectors, stopcock valves, and hemodialysis connectors. In some embodiments, the sterile cap may be connected to any of a variety of different needleless injection sites. In one or more embodiments, after the sterile cap has been connected to the connector, it is not necessary to sterilize the connector (e.g., treat it with an alcohol swab) before each reconnection to another connector, because the connector will remain uncontaminated when connected to the sterile cap. The use of sterile caps (100, 200, 300, 400, 500, 600, 700) replaces the standard wiping procedure for cleaning the connector.

[0094] Another aspect of this disclosure relates to a method for sterilizing a medical connector. The method includes connecting a sterilization cap (100, 200, 300, 400, 500, 600, 700) of one or more embodiments to a medical connector, wherein the connection includes, when the medical connector is inserted into the sterilization cap (100, 200, 300, 400, 500, 600, 700), engaging the threads of the medical connector with threads on the outer surface of the sidewall of the housing (110, 210, 310, 410, 510, 610, 710) of the sterilization cap, such that the medical connector contacts a blocking feature.

[0095] Another aspect of this disclosure relates to a component. This component includes a sterile cap (100, 200, 300, 400, 500, 600, 700) connected to a medical connector according to one or more embodiments. In one or more embodiments, the medical connector is selected from Luer connectors or other needleless connectors with fittings. In one or more embodiments, the Luer connector may be selected from the group consisting primarily of: needleless connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors.

[0096] Another aspect of this disclosure relates to packaging. In one or more embodiments, sterilization caps (100, 200, 300, 400, 500, 600, 700) can be packaged into a strip configuration. The strip configuration may include a single-piece top fiber mesh to which several caps (100, 200, 300, 400, 500, 600, 700) are attached by a sealing layer. The strip configuration may also include individually sealed caps with individual top fiber mesh foils, and then a series of individually sealed caps are attached in an array to a strip made of a material such as plastic. Each top fiber mesh foil may have tabs that are attached to the strip material by an adhesive or by a sealant.

[0097] It is anticipated that the disinfection caps (100, 200, 300, 400, 500, 600, 700) disclosed herein and shown in the accompanying drawings can also be used with female Luer connectors (including female Luer connectors), wherein the blocking feature can be used to block the lumen of an open Luer connector to mitigate the entry of such disinfectants into the connector, thereby reducing the risk of disinfectants entering the bloodstream. Therefore, it is anticipated that the disinfection caps (100, 200, 300, 400, 500, 600, 700) disclosed herein and shown in the accompanying drawings can be used with both types of female Luer connectors.

[0098] While this disclosure has been shown and described with reference to certain exemplary embodiments, those skilled in the art will understand that various changes in form and detail may be made without departing from the spirit and scope of the embodiments of this disclosure. Additionally, the inner and / or outer shell of the sterilization cap may be formed by a single injection molding process or may be manufactured by other suitable processes. Furthermore, as will be readily understood by those skilled in the art, any feature or element of any exemplary embodiment of the present disclosure as described above and illustrated in the accompanying drawings may be implemented individually or in any combination of one or more, without departing from the spirit and scope of the embodiments of this disclosure.

[0099] In addition, the included drawings illustrate non-limiting examples of implementations of certain exemplary embodiments of this disclosure and are helpful in describing the related technology. Apart from the foregoing, any specific or relative dimensions or measurements provided in the drawings are exemplary and not intended to limit the scope or content of the claims.

[0100] Throughout this specification, references to "one embodiment," "some embodiments," "one or more embodiments," or "embodiment" refer to a particular feature, structure, material, or characteristic described in connection with an embodiment, which is included in at least one embodiment of this disclosure. Therefore, phrases such as "in one or more embodiments," "in some embodiments," "in one embodiment," or "in an embodiment" appearing throughout the specification do not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, particular features, structures, materials, or characteristics may be combined in any suitable manner.

[0101] While the disclosure herein provides for the description of specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of this disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatus of this disclosure without departing from the spirit and scope of this disclosure. Therefore, modifications and variations are intended to be included within the scope of the appended claims and their equivalents.

Claims

1. A disinfection cap, the disinfection cap comprising: case; Top wall; Cylindrical sidewalls, the cylindrical sidewalls having an inner surface defining a cavity; An open bottom formed by the cylindrical sidewalls has an opening leading to the cavity within the housing for receiving the hub of the Luer connector. A first open-cell foam structure is disposed within the cavity; A blocking feature disposed on a first open-cell foam structure, the blocking feature being configured as a protrusion, wherein the protrusion further includes an upper portion and a lower portion, the lower portion being configured to fluidly block the hub of the Luer connector, and a second open-cell foam structure, the second open-cell foam structure being adjacent to and disposed on top of the first open-cell foam structure and configured to fit around the lower portion of the protrusion; and A first fluid, the first fluid being releasably retained within the first open-cell foam structure disposed within the cavity; A second fluid, releasably retained within the second open-cell foam structure, wherein the first and second open-cell foam structures have the same outer diameter; and At least one thread on the outer surface of the housing.

2. The disinfection cap according to claim 1, wherein the cavity extends from the inner surface of the top wall toward the open bottom of the housing.

3. The disinfection cap according to claim 1, wherein the protrusion is disposed on the bottom surface of the first perforated foam structure.

4. The disinfection cap according to claim 1, wherein the first open-cell foam structure is disposed against the top wall, and the second open-cell foam structure has a hollow cylindrical shape configured to fit around the protrusion.

5. The disinfection cap according to claim 1, wherein the upper part of the protrusion has a diameter equal to that of the top wall, and the lower part of the protrusion has a diameter smaller than that of the upper part.

6. The disinfection cap according to claim 5, wherein the second open-cell foam structure is disposed against the bottom surface of the upper portion of the protrusion, the second open-cell foam structure having a hollow cylindrical shape configured to fit around the lower portion of the protrusion.

7. The disinfection cap according to claim 5, wherein the first perforated foam structure is disposed between the upper part of the protrusion and the top wall of the cavity.

8. The sterilization cap according to claim 1, wherein the at least one thread is sufficient to interlock with the mating feature of the Luer connector.

9. The sterilization cap according to claim 8, wherein the hub is secured within the inner surface of the cavity by interlocking at least a portion of the at least one thread with a mating feature on the hub of the Luer connector.

10. The sterilization cap according to claim 1, wherein the inner surface of the cavity is secured by an interference fit with the hub of the Luer connector.

11. The disinfection cap according to claim 1, wherein the first fluid is selected from the group consisting primarily of: isopropanol, ethanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidin, and antibiotics.

12. The disinfection cap according to claim 1, wherein the first fluid is alcohol.

13. The disinfection cap according to claim 1, wherein the protrusion is cylindrical.

14. The disinfection cap according to claim 7, wherein the second fluid is selected from the group consisting primarily of: isopropanol, ethanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, dichlorobenzyl alcohol, dehydroacetic acid, hexocide, triclosan, hydrogen peroxide, colloidal silver, benzyl chloride, benzalkonium chloride, otetanidin, and antibiotics.

15. The disinfection cap according to claim 7, wherein the second fluid is alcohol.

Images