Sterile cap

Abstract

A disinfecting cap for connecting to a medical connector is described; the disinfecting cap includes a housing having a top wall and side walls forming a cavity. In one or more embodiments, a retaining rod forming a fluid reservoir is disposed within the cavity for retaining a disinfectant. In one or more embodiments, a bellows capsule is disposed within the cavity for holding the disinfectant. Pressure build-up within the cavity due to insertion of a luer connector causes the disinfectant to be expelled, thereby disinfecting the luer connector.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to a disinfection cap device for disinfecting a respective medical connector. The present disclosure relates generally to a device for disinfecting and sterilizing an access port of a medical connector having a fitting. Generally, the present disclosure also relates to the field of threaded or interlocking fittings including medical caps and medical disinfection caps, particularly caps or disinfection caps for use with threaded fluid connectors. The present disclosure also relates to a male disinfection cap device for disinfecting a male threaded luer connector. BACKGROUND

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally classified into two categories: peripheral catheters and central venous catheters. When connected to a VAD to deliver medical fluids or medications, bacteria and other microorganisms can enter the patient's vasculature from the access hub, port, or valve. Each access hub, port, valve, or connection is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal. To reduce CRBSI cases and ensure proper use and maintenance of VADs, practice standards have been developed that include disinfection and cleaning procedures. The Society for Healthcare Epidemiology of America (SHEA) guidelines and the Infusion Nurses Standards (INS) guidelines incorporate disinfection caps.

[0003] In developed markets, when an IV catheter is used, a needleless connector is typically used to close the system before access to administer a drug or other necessary fluid to the patient via the catheter. The INS practice standard recommends the use of a needleless connector and states that it should be "thoroughly disinfected with alcohol, tincture of iodine, or chlorhexidine gluconate / alcohol combination prior to each access." Disinfection of the needleless connector ultimately aims to help reduce bacteria that can survive on the surface that can lead to various catheter-related complications, including CRBSI. Nurses typically complete this disinfection task using a 70% isopropyl alcohol (IPA) pad, which is a so-called "hub swab." However, compliance with this practice is typically low. In addition to the lack of compliance with "hub swabbing," through interviews with clinicians, it was noted that the swabbing time, dry time, and number of swabs of the needleless connector often varied.

[0004] There is a growing need to protect both male and female Luer connectors to reduce central line-associated bloodstream infections (CLABSI) and peripheral line-associated bloodstream infections (PLABSI). If not properly protected, the threaded male Luer connectors on IV gravity kits and syringes can become contaminated. Currently, when IV connectors are disengaged from central or peripheral lines to temporarily stop infusion, nurses typically loop the male Luer connector to a Y-site needleless connector or wrap it in an isopropyl alcohol (“IPA”)-soaked tissue or cloth. However, this protection is very weak and does not adequately protect the Luer connector from touch contamination. Sterilization caps have emerged as a modern sterilization and protection device to sterilize the male Luer connector and create a physical barrier on it to prevent microbial growth.

[0005] Throughout the entire procedural sequence associated with the spread of microorganisms that can lead to CRBSI, there are numerous risks of exposure 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 elements with exposed lumens. Because the procedure for connecting to a VAD is so common and simple, the risks associated with access to the patient's vascular system are often overlooked. Currently, risk control for both the hospital and the patient is a substantial function of the due diligence performed by the clinician performing the connection, and this due diligence is largely uncontrollable.

[0006] Due to the biotoxicity of disinfectants at high doses, disinfectants typically have a systemic exposure threshold limit when infused into the bloodstream. Therefore, a disinfection device is needed that can block the lumen of open Luer fittings to reduce the entry of such disinfectants into the connector, thereby lowering the risk of disinfectant entering the bloodstream. A mechanism is needed to prevent disinfectant from entering the lumen and fluid path while providing effective disinfection of surrounding connectors or joints. Summary of the Invention

[0007] A first aspect of this disclosure relates to a sterilization cap having cylindrical sidewalls, a cavity, and an open bottom. The cylindrical sidewalls have an inner surface defining the cavity and a top wall. The open bottom is formed by the cylindrical sidewalls and has an opening leading to the cavity within the housing for receiving the hub of a Luer connector. The sterilization cap also includes a retaining rod disposed within the cavity, the retaining rod having a proximal flange, a distal flange, and an elongated rod between the proximal and distal flanges, the distal flange of the retaining rod abutting the top wall of the cavity. A fluid reservoir is defined between the inner surface of the housing and the proximal and distal flanges of the retaining rod. A disinfectant is disposed within the fluid reservoir and is initially held within the fluid reservoir. The hub of the Luer connector is received within the inner surface of the cavity.

[0008] In one or more embodiments, the diameter of the proximal flange of the retention stem is equal to or slightly greater than the diameter of the proximal portion of the cavity, configured to have an interference fit sufficient to create a fluid seal between the proximal flange of the retention stem and the proximal portion of the cavity.

[0009] In one or more embodiments, the diameter of the elongated stem is configured to flex into a final state when the hub of the luer connector is received within the cavity upon insertion of the hub of the luer connector, thereby breaking the fluid seal between the proximal flange and the proximal portion of the cavity and releasing the sterilizing agent into the cavity, sterilizing the hub and the periphery of the luer connector.

[0010] In one or more embodiments, at least one circular fin is disposed on the elongated stem, the at least one fin having a thickness configured to be elastically deformable, whereby a pressure build-up within the fluid reservoir caused by the insertion of the luer connector causes the at least one fin to deform.

[0011] In one or more embodiments, the diameter of the elongated stem is configured to compress when the hub of the luer connector is received within the cavity upon insertion of the hub of the luer connector.

[0012] In one or more embodiments, the diameter of the distal flange of the retention stem is equal to or greater than the diameter of the distal portion of the cavity, configured to create an interference fit sufficient to removably hold the retention stem within the cavity.

[0013] In one or more embodiments, the distal flange of the retention stem is bonded to the top wall of the cavity. In one or more embodiments, the distal flange of the retention stem is chemically bonded to the top wall of the cavity. In one or more embodiments, the distal flange of the retention stem is integrally formed with the top wall of the cavity.

[0014] In one or more embodiments, the hub of the luer connector is received within the inner surface of the cavity. In one or more embodiments, the sterilizing cap is secured by at least one thread or set of protrusions included on the outer surface of the housing, the at least one thread sized and threaded pattern designed to engage with a standard ISO-2 type luer fitting. In one or more embodiments, the hub is secured within the cavity of the sterilizing cap by interlocking at least a portion of the at least one thread with a matching feature on the hub of the luer connector when the hub of the luer connector is received within the inner surface of the cavity. In one or more embodiments, the cavity is configured to facilitate a loose fit between the cavity and the hub of the luer connector.

[0015] A second aspect of the present disclosure relates to a disinfectant cap having a cylindrical sidewall, a cavity, an open bottom, and a corrugated capsule disposed within the cavity. The cylindrical sidewall has an inner surface defining the cavity and a top wall. The open bottom is formed by the cylindrical sidewall, the open bottom having an opening into the cavity of the housing for receiving a hub of a luer connector. The corrugated capsule has a proximal surface, a distal surface, and an elongated body between the proximal surface and the distal surface, the distal surface of the corrugated capsule abutting the top wall of the cavity, the corrugated capsule having a fluid storage chamber. A disinfectant is disposed within the fluid storage chamber, the disinfectant being held within the fluid storage chamber in an initial state. The hub of the luer connector is received within the inner surface of the cavity.

[0016] In one or more embodiments, the elongated body further comprises at least one or more corrugated segments configured to collapse on one another upon insertion of the hub into the cavity of the housing.

[0017] In one or more embodiments, the corrugated capsule further comprises a slit in fluid communication with the fluid storage chamber, the slit disposed on the proximal surface of the corrugated capsule. In one or more embodiments, wherein in an initial uncompressed state, the slit is fluidically closed due to negative pressure within the fluid storage chamber, the fluid storage chamber holding the disinfectant. In one or more embodiments, upon compression of the elongated body due to insertion of the hub of the luer connector, the at least one corrugated segment collapses on one another causing a pressure build-up within the storage chamber, the pressure build-up causing the slit to deform and open causing the disinfectant to be expelled from the slit disinfecting the hub and the periphery of the luer connector.

[0018] In one or more embodiments, the corrugated capsule further comprises a plurality of perforations in fluid communication with the fluid storage chamber, the plurality of perforations disposed on the elongated body of the corrugated capsule. In one or more embodiments, the plurality of perforations are arranged in at least one row of perforations, the at least one row of perforations disposed longitudinally on the elongated body.

[0019] In one or more embodiments, in an initial uncompressed state, the plurality of perforations are fluidically closed due to negative pressure within the fluid storage chamber and the fluid storage chamber holds the disinfectant.

[0020] In one or more embodiments, upon compression of the elongated body due to insertion of the hub of the luer connector, the at least one corrugated segment collapses on one another causing a pressure build-up within the storage chamber, the pressure build-up causing the plurality of perforations to deform and open causing the disinfectant to be expelled from the plurality of perforations disinfecting the hub and the periphery of the luer connector.

[0021] In one or more embodiments, the distal surface of the corrugated capsule further comprises an aperture extending through the distal surface.

[0022] In one or more embodiments, the proximal surface of the bellows capsule is an open proximal surface. In one or more embodiments, the disinfecting cap further comprises an end cap abutting an engagement surface of the open proximal surface. In one or more embodiments, the end cap comprises a plurality of apertures configured to be disposed about a periphery of the end cap. In one or more embodiments, the plurality of apertures are positioned a distance from a center of the end cap so as not to direct a flow of fluid into a lumen of a hub of the luer connector.

[0023] In one or more embodiments, wherein in an initial uncompressed state, the plurality of apertures are configured to not discharge disinfectant due to negative pressure within the fluid reservoir. In one or more embodiments, wherein in a final compressed state, pressure build-up causes the disinfectant to be discharged through the plurality of apertures, thereby disinfecting the hub and periphery of the luer connector.

[0024] A third aspect of the present disclosure relates to a disinfecting cap having a cylindrical sidewall, a cavity, and a bellows capsule disposed within the cavity. The cylindrical sidewall has an inner surface defining the cavity and a top wall. An open bottom is formed by the cylindrical sidewall having an opening into the cavity of the housing for receiving a hub of a luer connector. The bellows capsule is disposed within the cavity, the bellows capsule having an open proximal end, a closed distal end, and an elongated body between the open proximal end and the closed distal end, the distal end of the bellows capsule abutting the top wall of the cavity, the bellows capsule having a fluid reservoir. A disinfectant is disposed within the fluid reservoir, the disinfectant being retained within the fluid reservoir in an initial state. A piston is disposed against the open proximal end. The hub of the luer connector is received within the inner surface of the cavity.

[0025] In one or more embodiments, the elongated body further comprises at least one bellows segment configured to collapse on one another upon insertion of the hub into the cavity of the housing.

[0026] In one or more embodiments, the housing further comprises a double-winged protrusion disposed on the distal portion of the housing.

[0027] In one or more embodiments, the piston comprises a proximal portion having a diameter equal to or slightly smaller than a diameter of the bellows cap, and a distal portion having a diameter substantially equal to a diameter of the fluid reservoir, the distal portion being configured to be positioned within the bellows capsule creating a liquid-tight seal.

[0028] In one or more embodiments, the piston further comprises a plurality of apertures extending from the distal portion of the bellows capsule to a proximal port of the bellows capsule, the plurality of apertures being in fluid communication with the fluid reservoir and configured to discharge the disinfectant upon compression of the bellows capsule.

[0029] In one or more embodiments, the piston further comprises a plurality of directional channels disposed on a proximal surface of the proximal portion of the piston, the plurality of directional channels configured to direct the disinfectant toward a periphery of a luer hub of the luer connector.

[0030] In one or more embodiments, the plurality of directional channels are configured to be disposed about a periphery of the proximal surface of the piston, the plurality of directional channels positioned a distance away from a center of the proximal surface so as to not direct fluid flow into a lumen of the hub of the luer connector. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 A front view of a disinfection cap according to an exemplary first embodiment of the present disclosure is shown;

[0032] Figure 2 A side perspective view front view of a disinfection cap according to the first embodiment of Figure 1 is shown;

[0033] Figure 3A A cross-sectional view of a retention rod disposed within the disinfection cap along an axis X-X’ of the disinfection cap according to the first embodiment of Figure 1 is shown;

[0034] Figure 3B A perspective exploded view of a disinfection cap according to the first embodiment of Figure 1 is shown;

[0035] Figure 4A A perspective view of a retention rod disposed within the disinfection cap according to the first embodiment of Figure 1 is shown;

[0036] Figures 4B to 4D A side view of the retention rod of the disinfection cap according to the first embodiment of Figure 1 is shown;

[0037] Figure 5 A cross-sectional front view of a disinfection cap and a retention rod disposed within the disinfection cap according to an exemplary second embodiment of the present disclosure is shown;

[0038] Figure 6A A perspective view of a retention rod according to the second embodiment of the present disclosure is shown;

[0039] Figure 6B A side view of the retention rod of the disinfection cap according to the second embodiment of the present disclosure is shown in an initial uncompressed state; Figure 5

[0040] Figure 6C A side view of the retention rod of the disinfection cap according to the second embodiment of the present disclosure is shown in a final compressed state; Figure 5

[0041] Figure 7 ​​A side perspective cut view showing a disinfectant cap and a corrugated capsule disposed therein according to an exemplary third embodiment of the present disclosure is shown;

[0042] Figures 8A to 8C A perspective view showing a corrugated capsule of the disinfectant cap is shown; Figure 7

[0043] Figure 9A A side perspective cut view showing a disinfectant cap and a corrugated capsule disposed therein according to an exemplary fourth embodiment of the present disclosure is shown;

[0044] Figure 9B A perspective view showing a corrugated capsule of the disinfectant cap is shown; Figure 9A

[0045] Figure 10 An exploded view showing a disinfectant cap and a corrugated capsule and an end cap disposed therein according to an exemplary fifth embodiment of the present disclosure is shown;

[0046] Figures 11A to 11C A perspective view showing a corrugated capsule of the disinfectant cap is shown; Figure 10

[0047] A perspective view showing an end cap of the disinfectant cap is shown; Figure 11D Figure 10 A cut view showing a corrugated capsule and an end cap abutting a hub of a luer connector according to the fifth embodiment of the present disclosure is shown;

[0048] Figure 12 A perspective view showing a disinfectant cap according to an exemplary sixth embodiment of the present disclosure is shown; Figure 10 A cut view showing a disinfectant cap according to the sixth embodiment of the present disclosure is shown;

[0049] Figure 13A An exploded view showing a disinfectant cap according to the sixth embodiment of the present disclosure is shown;

[0050] Figure 13B A perspective view showing a piston of the disinfectant cap is shown; Figure 13A

[0051] A cut view showing a corrugated capsule and a piston of the disinfectant cap is shown; Figure 13C Figure 13A An exploded view showing a disinfectant cap according to the sixth embodiment of the present disclosure is shown;

[0052] Figure 14A 14B A perspective view showing a piston of the disinfectant cap is shown; Figure 13A

[0053] A cut view showing a corrugated capsule and a piston of the disinfectant cap is shown; Figure 15A Figure 13A A perspective view showing a corrugated capsule of the disinfectant cap is shown;

[0054] Figure 15B Figure 13A ​​​​​​​Perspective view of a piston of a bellow capsule and a sterilization cap. DETAILED DESCRIPTION

[0055] Embodiments of the present disclosure relate to a sterilization cap for connecting to and sterilizing a medical connector, including a threaded connection. In one or more embodiments, the medical connector is a luer connector or a needleless connector. In one or more embodiments, the medical connector is a male luer connector. In one or more embodiments, the medical connector is a female luer connector. The present disclosure aims to provide a mechanism that prevents the ingress of sterilization agent into the fluid path of the medical connector while providing effective sterilization of the hub and surrounding periphery of the medical connector.

[0056] Before several exemplary embodiments of the present disclosure are described, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or being carried out in various ways.

[0057] For purposes of the description hereinafter, the terms "top", "bottom", "longitudinal", and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. However, it is to be understood that the disclosure can assume alternative variations and step sequences, except where expressly

[0058] As used herein, the use of "a", "an" and "the" includes singular and plural.

[0059] 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.

[0060] As used herein, the term "luer connector" refers to a connecting collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubing, etc. to each other. Luer connectors consist of one or more interlocking tubes that are slightly tapered so as to hold together better with a simple pressure / twist fit. Luer connectors can optionally include an additional threaded outer rim that makes them more secure. Luer connectors are commonly associated with flush syringes and can interlock and connect with an end located on a vascular access device (VAD). The luer connector, which includes a distal end, a proximal end, an irregularly shaped outer wall, a contoured central passageway for fluid communication from a chamber of a syringe barrel to a hub of a VAD. The luer connector also has a distal end channel and a proximal end channel, the distal end channel releasably attaching the luer connector to the hub of the VAD, the proximal end channel releasably attaching the luer connector to the barrel of the syringe. The term "luer connector" as used herein refers to a male luer connector or a female luer connector.

[0061] As used herein, the term "medical device" refers to a common medical device having a threaded or interlocking connection having a corresponding mating element. By way of example and not limitation, a syringe can have a threaded connection that releasably interlocks with a needleless connector of an ancillary medical device such as a catheter, IV line, etc. The threaded connection can include a lumen defining a fluid path surrounded by a protruding wall having a thread for attachment to the ancillary medical device.

[0062] As will be readily appreciated by one skilled in the relevant art, although descriptive terms such as "thread," "taper," "projection," "wall," "top," "side," "bottom," etc. are used throughout this specification to facilitate understanding, they are not intended to limit any component that can be used in combination or individually to practice various aspects of the present disclosure.

[0063] Embodiments of the disinfection cap of the present disclosure include a housing having a top wall defining a closed distal end, an open proximal end, and a substantially cylindrical sidewall extending from the closed end to the open proximal end, the sidewall having an inner surface. The cavity is configured to receive a hub of a needleless connector. In one or more embodiments, the cavity is configured to receive a hub of a threaded needleless connector. In one or more embodiments, the disinfection cap has at least one thread on an outer surface of the cylindrical sidewall sufficient to interlock with a mating feature of a threaded connection. Embodiments of the disinfection cap disclose at least one thread of the disinfection cap that engages a mating feature of a threaded connection, more specifically a luer connection. The cap further includes a capsule having perforations that function as a disinfectant reservoir configured to release a disinfectant fluid upon insertion of the hub of the needleless connector. The capsule is further configured as a barrier feature to fluidically block an open lumen of the luer, thereby preventing disinfectant from entering the open luer upon insertion of the luer connector into the cavity of the housing. In one or more embodiments, the open proximal end of the housing includes a peripheral bead extending radially outward from the outer surface of the sidewall, the peripheral bead defining an end face and an engagement surface for a removable seal and / or septum to maintain a sterile condition of the cavity. The removable seal reduces or prevents contamination of the cavity during shipping and storage of the disinfection cap. The removable seal is typically maintained sealed in an activation prior state until immediately prior to connection to a VAD or injection and / or aspiration procedure, at which time the peelable seal is removed. The removable seal minimizes potential particulate ingress hazards and provides a substantially impermeable enclosure for the cavity prior to use of the disinfection cap. The removable seal provides adequate sealing over a range of temperature, pressure, and humidity levels. In one or more embodiments, the removable seal is a peelable seal.

[0064] The disinfection cap provides a mechanical barrier for the connector and contains a disinfectant fluid or antimicrobial agent (hereinafter referred to as "fluid"). The disinfection cap of the present disclosure allows a practitioner to simplify the disinfection process. What is illustrated in the present description is provided to facilitate a thorough understanding of exemplary embodiments of the present disclosure. Thus, it will be apparent to one of ordinary skill in the art that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. Furthermore, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

[0065] Specifically, a medical practitioner can sterilize the needleless connector in a single action by inserting or screwing a sterilizing cap onto it. This causes a blocking feature to prevent fluid from entering the fluid path of the hub of the needleless connector, while insertion into the hub of the Luer connector causes fluid release, thereby allowing sterilization of the Luer connector hub and its periphery. In one or more embodiments, the sterilizing cap can then be removed by removing or unscrewing it from the Luer connector. In one or more embodiments, the sterilizing cap can remain attached to the Luer connector until ready for use, thus providing a closed environment for sterilization.

[0066] In exemplary embodiments of this disclosure, the sterilizing cap includes integrated threads or protrusions, and any and all combinations of other features that allow it to mate with a threaded connector of a medical device. In a preferred embodiment, the sterilizing cap mates with a Luer connector. Exemplary configurations of connectors, fittings, ports, and adapters may include commercially available Luer locks, Luer sliding ports, locking ports, threaded connections, interlocking connections, or other common medical device fittings generally known in the art.

[0067] Referring now to the accompanying drawings, in which the same reference numerals in several views denote the same or corresponding parts, embodiments of the present disclosure are described below.

[0068] like Figure 1 , Figure 2 As shown, a first embodiment of this disclosure relates to a sterilization cap 100, which includes a housing 110 having a distal portion 110A and a proximal portion 110B. In one or more embodiments, the proximal portion 110B is generally cylindrical. In one or more embodiments, the proximal portion 110B is tapered. In one or more embodiments, the distal portion 110A of the housing is tapered. In other embodiments, both the distal portion 110A and the proximal portion 110B are generally cylindrical. In one or more embodiments, the inner surface 126 of the proximal portion 110B of the housing 110 defines a cavity 130 having an open bottom 116 for receiving the hub of a pinless connector or, more specifically, a Luer connector. In one embodiment, the distal portion 110A is integrally formed with the proximal portion 110B. Further alternative embodiments are assembled non-removably or removably using threaded connections, press-fit connections, adhesive connections, or combinations thereof.

[0069] like Figure 3AAs shown, the cavity 130 has a proximal portion 132, a distal portion 134, and an intermediate portion 136 between the proximal portion 132 and the distal portion 134. In one or more embodiments, the proximal portion 132 has a shape that tapers inwardly from the open bottom 116 to the intermediate portion 136. In one or more embodiments, the distal portion 134 has a cylindrical shape. The intermediate portion 136 has a cylindrical shape. The distal portion 134 has a rounded or tapered shape that tapers inwardly from the intermediate portion 136 to the top wall 114. In one or more embodiments, the distal portion 134 has a rounded or chamfered transition from the distal portion 134 to the top wall 114.

[0070] In one or more embodiments, the cavity 130 is configured to facilitate a loose fit between the cavity 130 and the hub of a luer connector, wherein the disinfection cap 100 is secured by at least one thread 122 or a set of tabs included on the outer surface of the housing 110, the at least one thread 122 disposed on the proximal portion 110B. The at least one thread 122 disposed on the outer surface of the housing 110 is sized and threaded to engage with a standard ISO-2 type luer fitting. The loose fit allows fluid to flow around the hub of the luer connector. In other embodiments, the cavity 130 is configured as a luer slip fitting to facilitate an interference fit between the cavity 130 and the hub of a luer connector. In one or more embodiments, the interference fit is configured to be strong enough such that a threaded connection or at least one thread 122 is not needed to removably secure the cavity 130 to the luer connector.

[0071] 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 disinfection 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 can include a sloped thread pattern. In one or more embodiments, the at least one thread 122 can include a helical thread pattern. Such connectors are commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, the disinfection cap 100 provides a protective covering for the luer connector when engaged with the luer connector when the threads from the luer connector engage with the at least one thread 122 of the disinfection cap 100 and form a releasable connection.

[0072] Figure 3A An exploded view of the disinfection cap 100 is depicted along Figure 1 a cross-sectional view taken along the X-X’ plane is shown. Figure 3B An exploded view of the disinfection cap 100 is depicted along Figure 3A and 3BAs depicted, the cavity 130 of the housing 110 extends the length of the overall length of the housing 110 from the open bottom 116 to the top wall 114. The cavity 130 has a substantially cylindrical shape. Disposed within the cavity 130 is a retention post 150 configured to hold a fluid reservoir 160 of disinfectant. The retention post includes a proximal flange 152, a distal flange 154, and an elongate post 156 extending from the proximal flange 152 and the distal flange 154. The retention post 150 has a height from the proximal flange 152 to the distal flange 154 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal flange 152 and the distal flange 154 have equal diameters. In one or more embodiments, the proximal flange 152 has a diameter that is less than the diameter of the distal flange 154.

[0073] As shown in Figure 3A and 3B , the retention post 150 is disposed within the cavity 130 of the housing 110. The distal flange 154 abuts the top wall 114. The fluid reservoir 160 is defined between the inner surface 126 of the housing 110, the proximal flange 152, and the distal flange 154. The diameter of the proximal flange 152 is equal to or slightly greater than the diameter of the proximal portion 132 of the cavity 130, creating an interference fit sufficient to create a fluid seal between the proximal flange 152 and the proximal portion 132 of the cavity 130. The diameter of the distal flange 154 is equal to or greater than the diameter of the distal portion 134, creating an interference fit sufficient to removably retain the retention post 150 within the cavity 130. In one or more embodiments, the retention post 150 is integrally formed with the housing 110, connecting the distal flange 154 to the top wall 114 of the housing 110. In one or more embodiments, the distal flange 154 is chemically bonded to the top wall 114 of the housing 110 by an adhesive.

[0074] As shown in Figures 4A to 4C , the elongate post 156 is configured to flex when the hub of the luer connector is received within the cavity 130 with the hub of the luer connector inserted. In the initial unflexed state as shown in Figure 4A and Figure 4B , the retention post 150 holds the disinfectant within the fluid reservoir 160. In the final flexed state as shown in Figure 4C , the elongate post 156 flexes and elastically deforms, thereby breaking the fluid seal between the proximal flange 152 and the proximal portion 132 of the cavity 130. The breaking of the fluid seal opens the fluid reservoir, releasing the disinfectant into the cavity 130, and disinfecting the hub and the periphery of the luer connector. In one or more embodiments, as shown in Figure 4C , the proximal flange 152 deflects, thereby breaking the fluid seal between the proximal flange 152 and the proximal portion 132 of the cavity 130.

[0075] In one or more embodiments, the proximal flange 152 conforms to the hub of the male luer connector upon insertion of the male luer connector. In one or more embodiments, the elongated stem 156 flexes into a compound curvature while the proximal flange 152 does not rotate.

[0076] In alternative embodiments, compression of the retention stem 150 causes the proximal flange 152 to flex and rotate, as shown in Figure 4D .

[0077] In some embodiments, the retention stem 150 is made of a flexible TPE material, or more generally, a non-rigid plastic, allowing the retention stem 150 to flex and flex when pressure is applied due to luer connector insertion into the cavity 130.

[0078] According to a second embodiment of the present disclosure, as shown in Figure 5 and Figures 6A to 6C , an exemplary retention stem 250 of a disinfection cap 200 of the second embodiment is disclosed. The retention stem 250 of the second embodiment is disposed within the cavity 130 of the housing 110. The retention stem 250 includes a proximal flange 252, a distal flange 254, an elongated stem 256 extending from the proximal flange 152 and the distal flange 154, and at least one circular fin 258 disposed on the elongated stem 256. The distal flange 254 abuts the top wall 114 of the housing 110. The retention stem 250 has a height from the proximal flange 252 to the distal flange 254 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal flange 252 and the distal flange 254 have equal diameters. In one or more embodiments, the proximal flange 252 has a smaller diameter than the distal flange 254. The at least one circular fin 258 has a diameter that is less than or equal to the diameter of the middle portion 136 of the cavity 130.

[0079] In one or more embodiments, the diameter of the at least one circular fin 258 is configured to form an interference fit with the middle portion 136 of the cavity 130. In one or more embodiments, the interference fit of the at least one circular fin 258 with the middle portion 136 creates a fluid-tight seal. In one or more embodiments, the at least one circular fin 258 is configured to be able to deflect and elastically deform, thereby breaking the fluid-tight seal between the at least one circular fin 258 and the middle portion 136. In one or more embodiments, the at least one circular fin 258 supports the structure of the retention stem 250 and provides rigidity. In one or more embodiments, the at least one circular fin 258 is configured to be flexible enough to allow fluid leakage upon compression, but not to completely block fluid upon pressure growth. The at least one circular fin 258 is configured to increase surface area and surface tension to better retain fluid.

[0080] As shown in Figures 6A to 6CAs shown, the diameter of the elongated rod 256 is configured to compress when the hub of the Luer connector is received within the cavity 130 during hub insertion. In the case of... Figure 5 , Figure 6A and Figure 6B In the initial uncompressed state shown, the retaining rod 250 holds the disinfectant within the fluid storage chamber 260. Figure 6C In the compressed state shown, the elongated rod 256 compresses and elastically deforms, thereby breaking the fluid seal between the proximal flange 252 and the proximal portion 232 of the cavity 130. This disruption of the fluid seal opens the fluid reservoir, releasing disinfectant into the cavity 230 and disinfecting the hub and periphery of the Luer connector. In one or more embodiments, as... Figure 6C As shown, the proximal flange 252 deflects, thereby disrupting the fluid seal between the proximal flange 252 and the proximal portion 232 of the cavity 130. At least one fin 258 has a thickness configured to elastically deform, whereby pressure increases within the fluid reservoir 260 cause at least one fin 258 to deform. The retaining rod 150, made of a flexible TPE material, is configured to flex and buckle.

[0081] According to the third embodiment of this disclosure, as Figure 7 and Figures 8A to 8C The diagram illustrates an exemplary corrugated capsule 350 of a third embodiment of a sterilization cap 300. The corrugated capsule 350 of the third embodiment is disposed within a cavity 130 of a housing 110. The corrugated capsule 350 includes a proximal surface 352, a distal surface 354, and an elongated cylindrical body 356 extending from the proximal and distal surfaces 354. The distal surface 354 abuts against the top wall 114 of the housing 110. The elongated body 356 includes at least one corrugated segment 358 configured to collapse onto each other when pressure is applied to the proximal surface 352 due to the insertion of a Luer connector hub into the cavity 130 of the housing 120. The elongated body 356 has a height from the proximal surface 352 to the distal surface 354 equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal surface 352 and the distal surface 354 have equal diameters. In one or more embodiments, the diameter of the proximal surface 352 is smaller than the diameter of the distal surface 354.

[0082] like Figure 8A and 8BAs shown, the proximal surface 352 includes a slit 362 in fluid communication with a fluid reservoir 360, which is defined by a cavity extending from the proximal surface 352 to the distal surface 354 within an elongated cylindrical body 356. The slit 362 is disposed on the proximal surface 352. The distal surface 354 of the corrugated capsule 350 abuts against the top wall 114 of the cavity 130 of the housing 110. In the initial uncompressed state, the slit 362 is fluidly closed due to the negative pressure within the fluid reservoir 360, which retains the disinfectant. In the final compressed state, as the elongated cylindrical body 356 is compressed due to the insertion of the hub of the Luer connector, at least one corrugated segment 358 collapses onto each other, causing a pressure increase within the reservoir 360. This pressure increase causes the slit 362 to deform and open, resulting in the discharge of disinfectant from the slit 362, disinfecting the hub and periphery of the Luer connector.

[0083] like Figure 8C As shown, the distal surface 354 has a closed end. In one or more embodiments, the closed end of the distal surface 354 is chamfered. In one or more embodiments, the closed end of the distal surface 354 is rounded.

[0084] According to the fourth embodiment of this disclosure, as Figure 9A and Figure 9B An exemplary corrugated capsule 450 is disclosed. The corrugated capsule 450 of a fourth embodiment of the sterilization cap 400 is disposed within a cavity 130 of a housing 110. The corrugated capsule 450 includes a proximal surface 452, a distal surface 454, and an elongated cylindrical body 456 extending from the proximal surface 452 and the distal surface 454. The distal surface 454 abuts against the top wall 114 of the housing 110. The elongated body 456 includes at least one corrugated segment 458 configured to collapse onto each other when pressure is applied to the proximal surface 452 due to the hub of a Luer connector being inserted into the cavity 130 of the housing 120. The elongated body 456 has a height from the proximal surface 452 to the distal surface 454 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal surface 452 and the distal surface 454 have equal diameters. In one or more embodiments, the diameter of the proximal surface 452 is smaller than the diameter of the distal surface 454.

[0085] like Figure 9A and 9BAs shown, the elongated cylindrical body 456 includes a plurality of perforations 462 in fluid communication with a fluid storage chamber 460 defined by a cavity within the elongated cylindrical body 456 extending from the proximal surface 452 to the distal surface 454. In an uncompressed state, the distal surface 454 of the bellows capsule 450 abuts the top wall 114 of the cavity 130 of the housing 110. In the uncompressed state, the plurality of perforations 462 are configured to not discharge fluid. Upon compression of the elongated cylindrical body 456, the at least one bellows segment 458 collapses on one another causing a pressure build-up within the storage chamber 460. The pressure build-up causes the disinfectant to be discharged through the plurality of perforations 462, thereby disinfecting the hub and the periphery of the luer connector. The plurality of perforations 462 are arranged in at least one row of perforations 464 longitudinally disposed on the at least one bellows segment 458. Since the proximal surface 452 of the bellows capsule 450 is enclosed, the lumen of the hub of the luer connector is impermeably blocked from fluid such that the disinfectant cannot enter the lumen. In one or more embodiments, the plurality of perforations 462 are arranged in two or more rows of perforations 464 longitudinally disposed on the at least one bellows segment 458. In one or more embodiments, the plurality of perforations 462 are comprised of a self-sealing material.

[0086] A fifth embodiment of a disinfecting cap 500 according to the present disclosure is disclosed as shown in Figure 10 、 Figures 11A to 11D and Figure 12 A bellows capsule 550 of the third embodiment is disposed within the cavity 130 of the housing 110. As shown in Figure 10 The bellows capsule 550 includes an end cap 570 disposed on a proximal surface 552 of the bellows capsule 550. The bellows capsule 550 includes a proximal surface 552, a distal surface 554, and an elongated cylindrical body 556 extending from the proximal surface 552 and the distal surface 554. The distal surface 554 abuts the top wall 114 of the housing 110. The elongated body 556 includes at least one bellows segment 558 configured to compress on one another upon the application of pressure on the proximal surface 552 due to the insertion of the luer connector hub into the cavity 130 of the housing 120. The elongated body 556 has a height from the proximal surface 552 to the distal surface 554 that is equal to or slightly less than the height of the cavity 130. In one or more embodiments, the proximal surface 552 and the distal surface 554 have equal diameters. In one or more embodiments, the proximal surface 552 has a smaller diameter than the distal surface 554. The elongated cylindrical body 556 includes a fluid storage chamber 560 defined by a cavity within the elongated cylindrical body 556 extending from the proximal surface 552 to the distal surface 554.

[0087] As shown in Figure 11AAs shown, the distal surface 554 of the corrugated capsule 550 has an aperture 562 extending through the distal surface 554. As shown in Figure 11B and 11C As shown, the proximal surface 552 of the corrugated capsule 550 is open, the proximal surface 552 having an engagement surface that abuts the end cap 570. As shown in Figure 11C and Figure 11D As shown, the end cap 570 has a cylindrical body that includes a plurality of apertures 572 configured to be disposed about the periphery of the end cap 570. As shown in Figure 12 As shown in the cross-sectional view, the plurality of apertures 572 are located a distance away from the center of the end cap 570, thereby not introducing fluid into the lumen 24 of the hub 22 of the luer connector 20. Thus, the disinfectant is prevented from entering the lumen 24 upon ejection of the disinfectant.

[0088] In an initial uncompressed state, the distal surface 554 of the corrugated capsule 550 abuts the top wall 114 of the cavity 130 of the housing 110. In a final compressed state, upon compression of the elongated cylindrical body 556, the at least one corrugated segment 558 collapses on one another, causing a pressure build-up within the reservoir chamber 560. In the uncompressed state, the plurality of apertures 572 are configured to not discharge disinfectant due to the negative pressure within the fluid reservoir chamber 560. In the final compressed state, the pressure build-up causes the disinfectant to be discharged through the plurality of apertures 572, thereby disinfecting the hub and periphery of the luer connector.

[0089] As shown in Figures 13A to 13C , Figure 14A and Figure 14B A sixth embodiment of the present disclosure relates to a disinfecting cap 600 that includes a housing 610 having a distal portion 610A and a proximal portion 610B. In one or more embodiments, the proximal portion 610B is generally cylindrical, having a cylindrical housing 610. In one or more embodiments, the distal portion 610A of the housing has a double-winged protrusion 613 for gripping the cap 600. In one or more embodiments, the distal portion 610A and the proximal portion 610B have a substantially cylindrical sidewall. In one or more embodiments, an inner surface 626 of the proximal portion 610B of the housing 610 defines a cavity 630 having an open bottom 616 for receiving a hub of a luer connector. In one embodiment, the distal portion 610A is integrally formed with the proximal portion 610B. In one or more alternative embodiments, the distal portion 610A and the proximal portion 610B are assembled non-removably or removably by a threaded connection, a press-fit connection, an adhesive connection, or a combination thereof.

[0090] In one or more embodiments, the cavity 630 can be configured to facilitate a loose fit between the cavity 630 and the hub of the luer connector, with the disinfection cap 500 secured by at least one thread 622 or a set of tabs included on the outer surface of the housing 610. The at least one thread 622 disposed on the outer surface of the housing 610 is sized and threaded pattern designed to engage with a standard ISO-2 type fitting. The loose fit allows fluid to flow around the hub of the luer connector. In other embodiments, the cavity 630 is configured as a luer slip fitting to facilitate an interference fit between the cavity 630 and the hub of the luer connector. In some embodiments, the interference fit can be configured to be strong enough that a threaded connection or at least one thread 622 is not required to removably secure the cavity 630 to the luer connector.

[0091] In one or more embodiments, when the hub of the luer connector is received within the inner surface 626 of the cavity 630, the hub is secured within the cavity 630 of the disinfection cap 600 by interlocking at least a portion of the at least one thread 622 with a mating feature on the hub of the luer connector. In one or more embodiments, the at least one thread 622 can include a sloped thread pattern. In one or more embodiments, the at least one thread 622 can include a helical thread pattern. Such connectors are commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, the disinfection cap 600 provides a protective covering for the luer connector when engaged with the connector when the threads from the luer connector engage with the at least one thread 622 of the disinfection cap 600 and form a releasable connection.

[0092] Figure 13B A cross-sectional view of the disinfection cap 600 along the Y-Y’ plane is depicted. Figure 13A A cross-sectional view of the disinfection cap 600 along the Y-Y’ plane is depicted. Figure 13C An exploded view of the disinfection cap 600 is depicted, with the bellows capsule 650 disposed within the cavity 630. The bellows capsule 650 includes a closed distal end 654 and an open proximal end 652 defining a fluid storage chamber 660. Between the closed distal end 654 and the open proximal end 652 is an elongated cylindrical body 656. A piston 670 is disposed against the open proximal end 652. As Figure 13B A cross-sectional view of the disinfection cap 600 along the Y-Y’ plane is depicted. 13C As shown, the total length of the bellows capsule 650 and the piston 670 is equal to or less than the length of the cavity 630 of the housing 612.

[0093] As shown, the total length of the bellows capsule 650 and the piston 670 is equal to or less than the length of the cavity 630 of the housing 612. Figure 14A A cross-sectional view of the disinfection cap 600 along the Y-Y’ plane is depicted. 14BAs shown, the piston 670 includes a proximal portion 674 and a distal portion 676. The proximal portion 674 has a diameter that is equal to or slightly smaller than the diameter of the bellow capsule 650. The distal portion 676 has a diameter that is smaller than the diameter of the proximal portion 674. The distal portion 676 has a diameter that is smaller than or equal to the diameter of the fluid reservoir 660, such that the distal portion 676 is positioned within the fluid reservoir 660, creating a liquid-tight seal. The piston 670 also includes a plurality of orifices 672 extending from the distal portion 676 of the bellow capsule 650 to the proximal portion 674 of the bellow capsule 650. The plurality of orifices 672 are in fluid communication with the fluid reservoir 660 and are configured to expel the disinfectant upon compression of the bellow capsule 650. The piston also includes a plurality of directional channels 678 disposed on a proximal surface 679 of the proximal portion 674 of the piston 670. The plurality of directional channels 678 are configured to direct the disinfectant towards the periphery of the luer hub of the luer connector. The plurality of directional channels 678 are configured to be disposed around the periphery of the proximal surface 679 of the piston 670. The plurality of directional channels 678 are positioned a distance away from the center of the proximal surface 679 so as to not direct fluid flow into the lumen of the hub of the luer connector. Thus, the disinfectant can be prevented from entering the lumen upon expelling of the disinfectant.

[0094] As previously described, as Figure 15A and 15B As shown, the proximal portion 674 of the piston 670 has a diameter that is equal to or slightly smaller than the diameter of the bellow capsule 650. The distal portion 676 of the piston 670 has a diameter that is smaller than the diameter of the proximal portion 674. The distal portion 676 has a diameter that is smaller than or equal to the diameter of the fluid reservoir 660, such that the distal portion 676 is positioned within the fluid reservoir 660, creating a liquid-tight seal. The elongated cylindrical body 656 has at least one bellow segment 658 along the elongated cylindrical body 656. In one or more embodiments, the at least one bellow segment 658 defines a cross-section of the elongated cylindrical body 646 having a sidewall thickness that is smaller than a sidewall thickness of the elongated cylindrical body 656.

[0095] In an uncompressed state, the distal end 654 of the bellow capsule 650 abuts the top wall 614 of the cavity 630 of the housing 610. Upon compression of the elongated cylindrical body 656, the at least one bellow segment 658 collapses on one another, causing a pressure build-up within the reservoir 660. In the uncompressed state, the plurality of orifices 672 are configured to not discharge fluid due to the negative pressure within the fluid reservoir 660. The pressure build-up causes the disinfectant to be discharged through the plurality of orifices 662, disinfecting the hub and the periphery of the luer connector.

[0096] The corrugated capsule (350, 450, 550, 650) is made of a flexible elastomeric material. The sterilization cap (100, 200, 300, 400, 500, 600) is made of any of a variety of types of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, TPU, TPE, PVC, LSR, EPDM, Viton, acrylonitrile-butadiene-styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the sterilization cap (100, 200, 300, 400, 500, 600) comprises a polypropylene or polyethylene material.

[0097] In one or more embodiments, the disinfectant is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methyl paraben, ethyl paraben, propyl paraben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, ethanol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof. In a particular embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0098] In one or more embodiments, the sterilization cap (100, 200, 300, 400, 500, 600) can include a removable peel seal covering the opening of the cavity (130, 630). In one or more embodiments, the peel seal includes an aluminum or multi-layer polymer film peelable top piece. In a particular embodiment, the peelable is heat or induction sealed to the open end of the sterilization cap (100, 200, 300, 400, 500, 600). In one or more embodiments, the peel seal includes a moisture barrier layer.

[0099] In one or more embodiments, the connector of the medical device can be selected from the group consisting essentially of: a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector on a primary IV gravity set, a secondary IV gravity set, an extension set, and an infusion or syringe pump set. In some embodiments, the disinfecting cap can be connected with any of a variety of different needleless injection sites. In one or more embodiments, after the disinfecting cap has been coupled with the connector, there is no need to disinfect the connector (e.g., with an alcohol swab) prior to each reconnection of the connector with another connector, as the connector will remain uncontaminated when coupled with the disinfecting cap. The use of the disinfecting cap (100, 200, 300, 400, 500, 600) replaces the standard swabbing protocol for cleaning the connector.

[0100] Yet another aspect of the present disclosure relates to a method of disinfecting a medical connector. The method includes connecting the disinfecting cap (100, 600) of one or more embodiments to the medical connector, wherein the connecting includes engaging threads of the medical connector to threads on an outer surface of a sidewall of a housing (110, 610) of the disinfecting cap when the medical connector is inserted into the disinfecting cap (100, 200, 300, 400, 500, 600) such that the medical connector compresses a contact portion of the bellows capsule (350, 450, 550, 650).

[0101] It is contemplated that the disinfecting cap (100, 200, 300, 400, 500, 600) disclosed herein and shown in the drawings can also be used with luer connectors, including female luer connectors and male luer connectors, where a blocking feature can be used to block a lumen of an open luer to facilitate inhibiting such disinfectant from entering the connector, thereby reducing the risk of the disinfectant entering the bloodstream. Thus, it is contemplated that the disinfecting cap (100, 200, 300, 400, 500, 600) disclosed herein and shown in the drawings can be used with male luer connectors and female luer connectors.

[0102] While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it is to be understood that various other changes or modifications can be made to the present disclosure without departing from the spirit and scope of the embodiments of the present disclosure. Additionally, the inner housing and / or the outer housing of the disinfecting cap can be single shot molded or made by other suitable processes. Furthermore, as will be readily appreciated by those skilled in the art, any of the features or elements of any of the exemplary implementations of the embodiments of the present disclosure as described above and shown in the drawings can be implemented individually or in any combination, without departing from the spirit and scope of the embodiments of the present disclosure.

[0103] Furthermore, the included drawings describe, by way of non-limiting examples, implementations of the embodiments of certain example embodiments of the present disclosure and aid in the description of the associated technology. Except as otherwise noted herein, any specific or relative dimensions or measurements provided in the drawings are exemplary and not limiting.

[0104] References throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments" or "an embodiment" mean that a particular feature, structure, material, or characteristic being referred to is included in at least one embodiment of the present disclosure. Thus, the appearances of such phrases in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments.

[0105] While the disclosure has been illustrated and described in relation to particular embodiments, it will be apparent that various modifications and changes can be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. It is to be understood that the above description only illustrates and describes the principles of the present disclosure and the application. It will be apparent to those skilled in the art that numerous modifications and variations can be made to the methods and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Accordingly, the disclosure is intended to embrace all such modifications and variations as fall within the scope of the appended claims and their equivalents.

Claims

1. A sterilization cap with a shell, comprising: A cylindrical sidewall, the cylindrical sidewall having an inner surface and a top wall defining a cavity. An open bottom formed by the cylindrical sidewalls, the open bottom having an opening leading to the cavity within the housing for receiving the hub of the Luer connector; A retaining rod disposed within the cavity has a proximal flange, a distal flange, and an elongated rod between the proximal and distal flanges, the distal flange of the retaining rod abutting against the top wall of the cavity; A fluid storage chamber defined between the inner surface of the housing, the proximal flange of the retaining rod, and the distal flange of the retaining rod; as well as, The disinfectant is disposed in the fluid storage chamber and is initially held in the fluid storage chamber, wherein the hub of the Luer connector is received within the inner surface of the cavity; Wherein, the diameter of the proximal flange of the retaining rod is equal to or slightly larger than the diameter of the proximal portion of the cavity, and the diameter of the proximal flange of the retaining rod is configured to have an interference fit sufficient to create a fluid seal between the proximal flange of the retaining rod and the proximal portion of the cavity; Wherein, the height of the retaining rod from the proximal flange to the distal flange is equal to or slightly less than the height of the cavity; and The elongated rod is configured such that when the hub of the Luer connector is inserted and received within the cavity, it bends to its final state, thereby breaking the fluid seal between the proximal flange and the proximal portion of the cavity and releasing disinfectant into the cavity to disinfect the hub and periphery of the Luer connector.

2. The disinfection cap according to claim 1, wherein, At least one circular fin is disposed on the elongated rod, the thickness of the at least one circular fin being configured to be elastically deformable, thereby causing the at least one fin to deform due to the pressure increase in the fluid storage chamber caused by the insertion of the Luer connector.

3. The disinfection cap according to claim 1, wherein, The diameter of the elongated rod is configured to compress when the hub of the Luer connector is received within the cavity during insertion of the Luer connector hub.

4. The disinfection cap according to claim 1, wherein, The diameter of the distal flange is equal to or greater than the diameter of the distal portion of the cavity, and the diameter of the distal flange is configured to produce an interference fit sufficient to removably retain the retaining rod within the cavity.

5. The disinfection cap according to claim 1, wherein, The disinfection cap is secured by at least one thread or a set of protrusions on the outer surface of the housing.

6. The disinfection cap according to claim 1, wherein, The retaining rod has a height from the proximal flange to the distal flange, the height being equal to or slightly less than the height of the cavity.

7. The disinfection cap according to claim 1, wherein, The distal flange is chemically bonded to the top wall of the cavity.

8. The disinfection cap according to claim 1, wherein, When the Luer connector is inserted, the proximal flange conforms to the hub of the Luer connector.

9. The disinfection cap according to claim 1, wherein, The slender rod bends into a complex structure, while the proximal flange does not rotate.

10. The disinfection cap according to claim 1, wherein, Compression of the retaining rod (150) causes buckling and rotation of the proximal flange.

11. The disinfection cap according to claim 5, wherein, The at least one thread can include an inclined thread pattern.

12. The disinfection cap according to claim 5, wherein, The at least one thread can include a helical thread pattern.

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