Sterilization cap to prevent reuse

Abstract

Describes a medical connector for connection to a corresponding medical connector. The medical connector includes a housing having a radial protrusion and a cavity defined by a closed end, an open end, a partially cylindrical side wall, and a radial side wall. The medical connector further includes an insert disposed within the housing, the insert including a locking tab having at least one thread on an inner wall of the locking tab and a recessed notch on an outer wall of the locking tab. At least one thread of the locking tab engages at least one thread of the corresponding medical connector. The recessed notch disposed within the cavity rotates from a first position to a second position, wherein the second position includes a locking structure for non-removably securing the insert to the housing while simultaneously allowing removal of the corresponding medical connector.

Description

Technical Field

[0001] The present disclosure generally relates to medical connectors. In particular, the present disclosure relates to mating elements of medical connectors having features for preventing reuse and features for disinfection. Background Art

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally divided into two categories: peripheral catheters and central venous catheters. When delivering fluids or medications to a patient, bacteria and other microorganisms can enter the patient's vascular system from access hubs and ports / valves when connected to a VAD. Each access hub, connector, port, or valve is associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

[0003] To reduce CRBSI incidents and ensure proper use and maintenance of VADs, practice standards including disinfection and cleaning procedures have been established.

[0004] Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and have also been incorporated into the Infusion Nurses Society (INS) guidelines in the United States.

[0005] In developed markets, when using an IV catheter, a needleless connector will typically be used to close the system and then access the needleless connector to deliver medications or other necessary fluids to the patient via the catheter. The INS practice standards recommend the use of needleless connectors and state that "prior to each access, consistent and thorough disinfection should be performed using alcohol, tincture of iodine, or a chlorhexidine gluconate / alcohol combination." The disinfection of needleless connectors ultimately aims to help reduce bacteria that can survive on surfaces and potentially cause various catheter-related complications, including CRBSIs. Nurses will typically perform this disinfection task by using 70% isopropyl alcohol (IPA) pads by performing a so-called "scrub the hub" maneuver. However, the compliance and level of disinfection due to this practice typically depend on the user's ability and competence. In addition to a lack of compliance with "scrub the hub," it has also been noted through clinician interviews that there are typically differences in scrub time, dry time, and the number of times the needleless connector is scrubbed.

[0006] Luer needleless connectors are used to reduce CRBSI incidents and ensure proper use and maintenance of VADs because threaded connectors are more secure than slip connectors. However, while threaded needleless connectors such as Luer threaded connectors are more secure, they require more manipulation by the clinician and the connection is not as fast as a Luer slip connector.

[0007] Accordingly, there is a need for a medical connector that is capable of being disinfected and preventing reuse to reduce the risk of disinfectant entering the bloodstream. In addition, there is a need for a device that cooperates with the medical connector, the device providing the security of a threaded connector and the ease of use of a sliding connector. SUMMARY OF THE INVENTION

[0008] One aspect of the present disclosure relates to a medical connector and a mating element of a medical connector (i.e., a needleless connector), the medical connector and the mating element of the medical connector having a housing, a locking structure, and an insert disposed within the medical connector. The housing has a generally cylindrical housing body, the generally cylindrical housing body having a radially projecting portion extending from the cylindrical housing body and a cavity defined by a closed end, an open end, a partially cylindrical inner sidewall, and a radially sidewall of the radially projecting portion of the housing body. In some embodiments, the closed end further includes an inner cavity for transferring fluid outside the closed end. The locking structure is disposed on a lateral portion of the radially sidewall of the cavity, the locking structure including an inclined tab. The insert is advanced into the cavity of the housing, the insert including a disc-shaped body having a distal surface, a proximal surface, a sidewall, and a locking tab extending proximally from the sidewall, the insert including at least one thread on an inner wall of the locking tab and a recessed notch disposed on a distal portion of an outer wall of the locking tab.

[0009] In one or more embodiments, the insert rotates from a first position defined by a medial portion of the radially sidewall to a locked position defined by the lateral portion including the locking structure. In one or more embodiments, when the recessed notch is advanced past the inclined tab, the recessed notch engages a ledge of the inclined tab. In one or more embodiments, the locking tab elastically deforms.

[0010] In one or more embodiments, the locking structure further includes an outwardly inclined surface that slopes outwardly from a medial position or a left position to a lateral position or a right position.

[0011] In one or more embodiments, the outwardly inclined surface extends at least partially along the length of an arc of the radially sidewall. In one or more embodiments, the outwardly inclined surface extends along the entire length of an arc of the radially sidewall.

[0012] In one or more embodiments, the inclined tab extends from a lateral portion of the outwardly inclined surface. In one or more embodiments, the outwardly inclined surface causes the locking tab to deform.

[0013] In one or more embodiments, the locking structure further includes a proximally inclined surface that is positioned adjacent to the ledge of the inclined surface.

[0014] In one or more embodiments, the proximally inclined surface is inclined inwardly from a distal position to a proximal position relative to the radial sidewall.

[0015] In one or more embodiments, when the insert is fully advanced into the cavity, the distal surface of the insert abuts the inner top surface of the cavity of the housing.

[0016] In one or more embodiments, the medical connector further includes an absorbent material that is disposed between the distal surface of the insert and the inner top surface of the cavity of the housing when the insert is fully advanced into the cavity. In one or more embodiments, the absorbent material includes a disinfectant.

[0017] In one or more embodiments, the full advancement of the insert into the cavity in a distal direction causes the distal surface of the insert and the inner top surface of the cavity of the housing to compress the absorbent material, such that the absorbent material releases the disinfectant. The disinfectant is discharged into the cavity through a gap defined by a partially cylindrical inner sidewall of the housing and the sidewall of the insert.

[0018] In one or more embodiments, the diameter of the partially cylindrical inner sidewall of the housing has a greater diameter than the sidewall of the insert.

[0019] In one or more embodiments, a retaining tab is disposed on the inner top surface of the housing that non-removably secures an orifice that extends through the distal surface and is disposed on the distal surface of the insert.

[0020] A second aspect of the present disclosure relates to a medical connector having a housing, a locking structure, and an insert disposed within the medical connector. The housing has a substantially cylindrical housing body having a radially projecting portion extending from the cylindrical housing body and a cavity defined by a closed end, an open end, a partially cylindrical inner sidewall, and a radial sidewall of the housing body. The locking structure is disposed on a side portion of the radial sidewall of the cavity and includes an inclined tab. The insert is advanceable into the cavity of the housing and includes a disc-shaped body having a distal surface, a proximal surface, a sidewall, and a locking tab extending proximally from the sidewall. The insert includes at least one thread disposed on an inner wall of the locking tab and a recessed notch disposed on a distal portion of an outer wall of the locking tab. Screwing a corresponding medical connector into the cavity causes the insert to be advanced into the cavity, and the corresponding medical connector has at least one thread to engage the at least one thread of the insert.

[0021] In one or more embodiments, the corresponding medical connector is removably screwed into the cavity.

[0022] A third aspect of the present disclosure relates to a medical connector for a syringe, the medical connector having a housing that projects in a distal direction from a distal sidewall of a syringe barrel of the syringe, the housing including a cavity defined by the distal sidewall of the syringe barrel, an open end opposite the distal sidewall, and a partially cylindrical sidewall extending from the distal sidewall to the open end, the housing further including a radial sidewall defined by a radially projecting portion that extends outwardly from the housing, the radially projecting portion and the radial sidewall being shaped as an arc projecting outwardly.

[0023] The syringe further includes a tapered ferrule disposed within the cavity of the housing, the tapered ferrule extending in a distal direction from the distal sidewall of the syringe barrel, the tapered ferrule configured to interleave with a corresponding cavity of a housing of a vascular access device.

[0024] The syringe further includes a locking structure disposed on the radial sidewall, the locking structure including an outwardly inclined surface and an inclined tab, the inclined surface being inclined outwardly from an inner or left position to a lateral or right position, the outwardly inclined surface extending at least partially along the length of the arc of the radial sidewall, the inclined tab being inclined outwardly from a lateral or right position to an inner or left position, the inclined tab including a ledge formed by a wall that is substantially perpendicular to the radial sidewall.

[0025] The syringe further includes an insert having a substantially disk-shaped body, the disk-shaped body having a proximal surface, a distal surface, a sidewall, locking tabs, and an aperture, the locking tabs extending from the distal surface, the aperture being disposed on the proximal surface of the disk-shaped body and extending through the proximal surface, the insert further including at least one thread disposed on an inner wall of the locking tab.

[0026] A first position is defined by an inner or left portion of the radial sidewall, and a locked position is defined by the inclined tab and the ledge. The housing is configured to receive a male Luer connector of a vascular access device. When the insert is advanced proximally into the cavity of the housing, the locking tabs are disposed in the first position, causing the locking tabs of the insert to elastically deform outwardly relative to the radial sidewall. When the insert is rotated towards the locked position, the outwardly inclined surface further elastically deforms the locking tabs inwardly until the recessed notch passes over the ledge of the radial sidewall, thereby preventing inward or leftward movement of the locking tabs when the recessed notch has passed over the ledge and the recessed notch irreleasably engages the ledge.

[0027] The third embodiment of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, an inner sidewall extending between the distal wall and the open end, and a cavity. At least one helical thread is provided on the inner sidewall of the cavity. A channel is provided on the inner sidewall, and the channel has a substantially rectangular profile extending from the distal wall to the open end. Absorbent material abuts the inner distal surface of the housing.

[0028] The medical connector further includes a leaf spring disposed in the channel. The leaf spring has a rectangular cross-section and an arcuate portion located between a distal portion and a proximal portion. The distal portion is non-removably attached to the channel, and the proximal portion abuts the channel in an initial state.

[0029] When a corresponding medical connector is advanced into the cavity, at least one thread of the corresponding medical connector presses the arcuate portion of the spring into the channel, causing the proximal portion of the spring to deflect away from the channel, thereby defining a final state. The proximal end of the proximal portion of the spring engages the lower segment of at least one thread of the corresponding medical connector, thereby locking the corresponding medical connector in the cavity in a threaded fit and an interference fit manner.

[0030] The fourth embodiment of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, an inner distal surface, and a cavity defined by the proximal open end and a closed distal end. The medical connector further includes a cup spring including a frustoconical disc-shaped body having at least two prongs extending from a proximal edge of the disc-shaped body. The at least two prongs extend in a proximal direction from the proximal edge of the disc-shaped body. Each of the at least two prongs includes a proximal portion and a distal portion adjacent to the proximal portion. The distal portion forms an inner hook extending toward the center of the disc-shaped body. The inner hook includes an inner edge configured to engage a corresponding thread of a corresponding medical connector. The medical connector further includes absorbent material abutting the inner distal surface of the housing.

[0031] Advancement of the corresponding medical connector into the cavity causes the disc-shaped body to deform inwardly, thereby pushing the proximal edge of the disc-shaped body against the lower segment of at least one thread of the corresponding medical connector, thereby locking the corresponding medical connector in the cavity.

[0032] The fifth embodiment of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, an inner sidewall extending between the distal wall and the open end, and a cavity. At least one helical thread is provided on the inner sidewall of the cavity. The helical thread has a distal portion integrally formed on the inner sidewall and a frangible portion proximal to the distal portion. The frangible portion is configured to separate and cross-thread when the corresponding thread of a corresponding medical connector is screwed and advanced into the cavity. Absorbent material abuts the inner distal surface of the housing.

[0033] The sixth embodiment of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, a sidewall extending between the distal wall and the open end, a cavity extending from the open end to the distal wall, an inner distal surface, and at least one toothed member extending medially from the inner sidewall of the housing into the cavity. The at least one toothed member is positioned at a distance from the inner distal surface of the housing.

[0034] The medical connector further includes an insert in the form of a disc-shaped body having a proximal surface and a distal surface; at least two locking tabs extending away from the distal surface in a distal direction along the distal surface. Each of the at least two locking tabs has a hooked proximal end configured to interlock with a corresponding thread of a corresponding medical connector; and a plurality of ridges provided on the sidewall of the disc-shaped body. The plurality of ridges are configured to interleave with at least one toothed member of the housing. Absorbent material abuts the inner distal surface of the distal wall of the housing.

[0035] The seventh aspect of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, a sidewall extending between the distal wall and the open end, and a cavity. The medical connector further includes an insert in the form of a C-shaped body having a distal end in the form of an arc and an open proximal end and two movable hinges extending from the distal end. Absorbent material abuts the inner distal surface of the distal wall of the housing.

[0036] Advancement of the corresponding medical connector into the cavity causes the C-shaped body to deflect, thereby locking the open proximal end against the thread of the corresponding medical connector.

[0037] The eighth aspect of the present disclosure relates to a medical connector. The medical connector includes a substantially cylindrical housing having a distal wall, a proximal open end, a sidewall extending between the distal wall and the open end, and a cavity, an inner distal surface, and an inner wall positioned at a distance from the inner distal surface of the housing.

[0038] The medical connector further includes an insert in the shape of a C-shaped body having a distal portion in the form of an arc, an open proximal portion, and at least two movable hinges extending tangentially to the distal portion. The absorbent material abuts an inner distal surface of the distal wall of the housing. The advancement of the corresponding medical connector into the cavity causes the insert to deflect, thereby threadedly locking against the open proximal end of the medical connector. The inner wall further includes an aperture configured to receive the distal portion of the insert. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1A A perspective view of a housing of a medical connector assembly according to a first exemplary embodiment of the present disclosure is shown;

[0040] Figure 1B As shown in Figure 1A A perspective side view of a housing body of a medical connector according to the embodiment shown is shown;

[0041] Figure 2A As shown in Figure 1A A perspective view of a bottom view of an insert of a medical connector according to the embodiment shown is shown;

[0042] Figure 2B As shown in Figure 1A A perspective view of a bottom view of an insert of a medical connector according to the embodiment shown is shown;

[0043] Figure 3 As shown in Figure 1A A perspective bottom view of a housing body of a medical connector according to the embodiment shown is shown;

[0044] Figure 4 As shown in Figure 1A A perspective side view of a housing body and an insert of a medical connector according to the embodiment shown is shown;

[0045] Figure 5 As shown in Figure 1A A perspective bottom view of a housing body of a medical connector according to the embodiment shown is shown;

[0046] Figure 6 As shown in Figure 1A A perspective bottom view of a housing body and an insert of a medical connector according to the embodiment shown is shown;

[0047] Figure 7 As shown in Figure 1A A bottom view of a housing body and an insert of a medical connector according to the embodiment shown is shown;

[0048] Figure 8 As shown in Figure 1ABottom view of the housing body and insert of the medical connector of the illustrated embodiment;

[0049] Figure 9 Shows a medical connector according to as Figure 1A Sectional side view of the housing body and insert of the medical connector of the illustrated embodiment;

[0050] Figure 10 Shows the elastic deformation of the locking tab in the first position and the locked position;

[0051] Figure 11 Cross-sectional view of a medical connector inserted into the housing body and insert of the medical connector;

[0052] Figure 12 Side perspective view of a medical connector inserted into the housing body and insert of the medical connector;

[0053] Figure 13A Perspective view of the housing of a syringe according to a second embodiment of the present disclosure.

[0054] Figure 13B Shows a syringe according to as Figure 13A Top view of the housing of the syringe of the second embodiment shown;

[0055] Figure 13C Shows a syringe according to as Figure 13A Perspective side view of the housing of the syringe of the second embodiment shown;

[0056] Figure 13D Shows a syringe according to as Figure 13A Perspective side view of the housing of the syringe of the second embodiment shown;

[0057] Figure 14A Shows a syringe according to as Figure 13A Perspective side view of the insert of the second embodiment shown;

[0058] Figure 14B Shows a syringe according to as Figure 13A Perspective side view of the insert of the second embodiment shown;

[0059] Figure 15 Shows a syringe according to as Figure 13A Perspective side view of the insert inserted into the housing of the syringe of the second embodiment shown;

[0060] Figure 16 Shows a syringe according to as Figure 13A Cross-sectional view of the insert inserted into the housing of the syringe of the second embodiment shown;

[0061] Figure 17Shows a perspective view of the housing of a medical connector according to a third embodiment of the present disclosure.

[0062] Figure 18A Shows a cross-sectional view of the housing in an initial state according to the third embodiment as Figure 17 shown;

[0063] Figure 18B Shows a cross-sectional view of the housing in an initial state according to the third embodiment as Figure 17 shown;

[0064] Figure 19 Shows a cross-sectional view of the housing in an initial state according to the third embodiment as Figure 17 shown;

[0065] Figure 20 Shows a cross-sectional view of the housing in a final state according to the third embodiment as Figure 17 shown;

[0066] Figure 21A Shows a cross-sectional view of the housing in an initial state according to a fourth embodiment of the present disclosure;

[0067] Figure 21B Shows a cross-sectional view of the housing in an initial state according to the fourth embodiment as Figure 21A shown;

[0068] Figure 22A Shows a cross-sectional view of the housing in a final state according to the fourth embodiment as Figure 21A shown;

[0069] Figure 22B Shows a cross-sectional view of the housing in a final state according to the fourth embodiment as Figure 21A shown;

[0070] Figure 22C Shows a cross-sectional view of the housing in a final state according to the fourth embodiment as Figure 21A shown;

[0071] Figure 23A Shows a perspective side view of the housing in an initial state according to a fifth embodiment of the present disclosure;

[0072] Figure 23B Shows a cross-sectional view of the housing in an initial state according to the fifth embodiment as Figure 23A shown;

[0073] Figure 24A Shows a cross-sectional view of the housing in a final state according to the fifth embodiment as Figure 23A shown;

[0074] Figure 24B shows a cross-sectional view of a housing in a final state according to a fifth embodiment as Figure 23A shown;

[0075] Figure 25A and Figure 25B shows a perspective view of an insert according to a sixth embodiment of the present disclosure;

[0076] Figure 26 shows an insert disposed within a housing of an exemplary medical connector according to a sixth embodiment of the present disclosure Figure 25A and Figure 25B in a cross-sectional view;

[0077] Figure 27 shows a cross-sectional view of an insert disposed within a housing of an exemplary medical connector according to a seventh embodiment of the present disclosure;

[0078] Figure 28A and Figure 28B shows a cross-sectional view of an insert disposed within a housing of an exemplary medical connector according to an eighth embodiment of the present disclosure. DETAILED DESCRIPTION

[0079] Embodiments of the present disclosure relate to a sterile medical connector for connecting to and disinfecting a corresponding medical connector having an open lumen, the corresponding medical connector including a male needleless connector, a female needleless connector, a luer connector, and a stopcock. In some embodiments, the medical connector may be a male luer connector or a female luer connector. In some embodiments, the medical connector may be a cap or a connector of a syringe. In some embodiments, the medical connector of the present disclosure is incorporated into a medical device. In some embodiments, the medical connector of the present disclosure is a mating element incorporated into a medical device. Embodiments of the medical connector include a housing, an insert, and an absorbent material, the insert and the absorbent material being disposed within the housing. When the corresponding medical connector is inserted into the housing, the corresponding medical connector is pushed against the housing and the insert, which compresses the absorbent material, thereby releasing an antimicrobial disinfectant solution or gel (hereinafter referred to as "disinfectant"), and in some embodiments preventing reuse of the medical connector and the corresponding medical connector. The disinfectant disinfects the corresponding medical connector. In one or more embodiments, the medical connector and the corresponding medical connector as described in detail below have means for single use, wherein the insert of the medical connector is irreleasably locked to the housing of the medical connector.

[0080] The housing includes a substantially cylindrical body having a radially projecting portion and a cavity defined by a closed end, an open end, a partially cylindrical inner sidewall of the housing, and a radially sidewall of the radially projecting portion. The inner sidewall of the housing has a length Lc extending from the closed end to the distal sidewall. In one or more embodiments, the open end includes a mating surface to which a peelable seal is attached.

[0081] In one or more embodiments, the insert includes an inner wall. In one or more embodiments, the inner wall of the insert has at least one thread adapted to engage a female Luer connector. The medical connector provides a mechanical barrier for the connector and contains an antimicrobial agent for disinfection. The medical connector of the present disclosure also allows a practicing physician to streamline the disinfection process while blocking the lumen of an open Luer fitting to facilitate mitigation of contaminants and disinfectants entering the open lumen of the connector, thereby reducing the risk of contaminants and disinfectants entering the bloodstream.

[0082] Regarding the terms used in the present disclosure, the following definitions are provided.

[0083] As used herein, the use of "a", "an", and "the" includes both singular and plural.

[0084] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or IV line.

[0085] As used herein, the terms "medical connector" and "corresponding medical connector" refer to needleless and non-needled medical connectors, such as BD MAXPLUS, BD MAXZERO TM 、STARTSITE TM 、NEUTRACLEAR TM 、BD Q-SYTE TM 。In addition, the terms "medical connector" and "corresponding medical connector" refer to sterile connectors having a male open lumen or a female open lumen, a Luer connector, and a stopcock. The terms "medical connector" and "corresponding medical connector" also refer to mating elements of needleless and non-needled connectors and can be incorporated into medical devices connected to a medical connector (e.g., a cap or a connector of a syringe). A medical connector can include an element connected to or mating with a corresponding medical connector, such as a male medical connector having an element mating with a corresponding female medical connector.

[0086] As used herein, the terms "needleless connector" and "corresponding needleless connector" refer to a combination of a male connector and a female connector. In the case where the needleless connector is a male needleless connector, the corresponding needleless connector is a female needleless connector. Similarly, in the case where the needleless connector is a female needleless connector, the corresponding needleless connector is a male needleless connector. A needleless connector can be a cap, a connector of a syringe, a connector of a vascular access device, a connector of a stopcock, a Luer connector with a corresponding open Luer connector, a connector with a valve, a connector lacking a valve, a manifold port, a stopcock, any conventional medical device with a needleless connector, or a conventional open Luer connector.

[0087] As used herein, the term "Luer connector" refers to a connection collar that is a standard way to attach syringes, catheters, hubbed needles, IV tubes, etc. to each other. A Luer connector consists of a male interlocking tube and a female interlocking tube, the male and female interlocking tubes being slightly tapered so that they can be held together better even with a simple press / twist fit. The Luer connector may optionally include an additional external threaded rim to allow them to be more secure. The male end of the Luer connector is typically associated with a flush syringe and can be interlocked and connected to the female end located on a vascular access device (VAD). The Luer connector also has a distal end that releasably attaches the Luer connector to the hub of the VAD and a proximal end that releasably attaches the Luer connector to the syringe barrel.

[0088] As used herein, ISO 80369-7:2016 defines the specifications of a standard Luer connector, which includes a 6% taper between the distal end and the proximal end. The male standard Luer connector increases from the open distal end towards the proximal end. The female standard Luer connector decreases from the open proximal end towards the distal end. According to ISO 80369-7:2016, the male standard Luer connector has an outer cross-sectional diameter measured at 0.75 mm from the distal end of the tip, which is between 3.970 mm and 4.072 mm. The length of the male standard Luer taper is between 7.500 mm and 10.500 mm. The outer cross-sectional diameter measured at 7.500 mm from the distal end of the tip is between 4.376 mm and 4.476 mm. As used herein, the phrases "male standard Luer connector" and "female standard Luer connector" shall refer to connectors having the dimensions described in ISO 80369-7, which is incorporated herein by reference in its entirety.

[0089] As will be readily understood by those skilled in the relevant art, although descriptive terms such as "locking", "end", "ferrule", "thread", "sponge", "fork head", "protrusion / insert", "tab", "bevel", "wall", "top", "side", "bottom", etc. are used throughout the specification for ease of understanding, they are not intended to limit any of the components that can be used in combination or alone to implement the various aspects of the embodiments of the present disclosure.

[0090] The matters illustrated in this specification contribute to a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, those of ordinary skill 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 the present disclosure. In addition, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0091] In one or more exemplary implementations of the embodiments of the present disclosure, the medical connector is in the form of a cap having mating elements (e.g., threads, tabs, or flanges) that connect to a corresponding medical connector. The cap includes a housing and an insert. The insert of the cap, connector cap, or sterilization cap includes at least one thread and any combination and all combinations of other features, thereby allowing it to engage with one or more corresponding threads of a female threaded fitting.

[0092] According to other exemplary implementations of the embodiments of the present disclosure, the configuration of the structural elements constituting the insert includes tabs protruding from the insert, and the tabs include at least one thread to connect to one or more corresponding threads of a corresponding medical connector.

[0093] According to additional exemplary implementations of the embodiments of the present disclosure, the female thread is sized and has a thread pattern that will engage with a male fitting of the standard ISO594-2 type, and / or the male thread is sized and has a thread pattern that will engage with a female fitting of the standard ISO594-2 type. An example of a fitting of the ISO594-2 type is a Q-type fitting.

[0094] According to additional exemplary implementations of the embodiments of the present disclosure, the tabs of the insert can be bent or elastically deformed to allow for better interference fit compliance with the fitting.

[0095] In one or more embodiments, the female medical connector can be selected from the group consisting essentially of needleless connectors, catheter luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the medical connector is selected from Q-Syte connectors, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0096] In one or more embodiments, the male medical connector can be an intravenous tube end or a stopcock. In some embodiments, the described medical connector is configured to receive a sliding connector such as a luer slip connector. In some embodiments, the described medical connector includes one or more engagement elements such as serrations or C-clamps that are configured to engage a threaded connector and a sliding connector by advancing the threaded connector or the sliding connector into the medical connector. In some embodiments, the described medical connector can engage a threaded connector such as a threaded luer connector by simply advancing the threaded connector into the medical connector without the clinician having to twist, turn, or torque the threaded connector or its mating elements.

[0097] In some embodiments, the serrations or C-clamp further include a set of tabs protruding from the distal end of the serrations or C-clamp. In the fully advanced position, the set of tabs interlocks with the threads of the corresponding medical connector. The set of tabs engages the threads of the needleless connector to irreversibly lock the corresponding medical connector. In some embodiments, the set of tabs is wider than a spring. In some embodiments, the set of tabs is configured to disengage from the corresponding threads and jump out of the thread path to prevent reuse.

[0098] In some embodiments, when the corresponding threaded medical connector is fully advanced, the medical connector of the embodiments described herein is configured to produce an audible click or sound that can be detected by a clinician or an auxiliary detection system.

[0099] Before describing several exemplary embodiments of the present disclosure, it should be understood that the present disclosure is not limited to the details of the construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0100] Referring now to the drawings, in which like reference numerals indicate like or corresponding parts in each view, embodiments of the present disclosure are described below.

[0101] A first aspect of the present disclosure relates to a housing 110 of a medical connector 100. As Figure 1A and Figure 1B shown, the medical connector is in the form of a cap. In some embodiments, the housing 110 relates to an element that is connected to or mates with a corresponding medical connector. The housing 110 of the medical connector 100 has a partially cylindrical shape that is integral with a radially projecting portion 180, which is in the form of a projecting arc. The angle of the projecting arc ranges from 10 degrees to 350 degrees. The housing 110 includes a cavity defined by a closed end 112, an open end 114, and a partially cylindrical inner sidewall 120. The partially cylindrical inner sidewall 120 is integral with a radial sidewall 182. The radial sidewall 182 of the housing 110 includes a locking structure described in more detail below.

[0102] The closed end 112 is located in a distal position and the open end 114 is located in a proximal position relative to the closed end 112. In one or more embodiments, the partially cylindrical inner sidewall 120 has a substantially constant diameter D IS . In one or more embodiments, the partially cylindrical inner sidewall 120 may further taper outwardly, where the tapered portion increases proximally toward the open end 114. The corresponding medical connector is received into the cavity 130 through the open end 114.

[0103] The housing 110 further includes an outer sidewall 116. The outer sidewall 116 in the depicted embodiment has a partially cylindrical shape, which has a smooth surface and a chamfer 118. In one or more embodiments, the chamfer 118 may be rounded. In one or more embodiments, the chamfer 118 may extend partially around the outer sidewall 116. In one or more embodiments, the outer sidewall 116 may have a plurality of axial ribs. In one or more embodiments, the outer sidewall 116 may have a plurality of radial ribs. In one or more embodiments, the outer sidewall 116 may have a gripping surface to facilitate manipulation by a practicing physician. The gripping surface may be textured or have a coating.

[0104] A second aspect of the present disclosure relates to an insert 150 disposed within the housing 110. As Figure 2A and Figure 2BAs shown, the insert 150 has a basic disk-shaped body 152 having a distal surface 154, a proximal surface 156, and a side wall 158. A locking tab 160 extends from the side wall 158, and the locking tab 160 extends in a proximal direction away from the proximal surface 156 of the disk-shaped body 152 from the proximal surface 156. In one or more embodiments, the disk-shaped body 152 includes an aperture 153 disposed on the distal surface 154 of the disk-shaped body 152, and the aperture 153 extends through the distal surface. The center of the aperture 153 is concentric with the center of the disk-shaped body 152. The disk-shaped body 152 has a diameter D DB , and the diameter D DB is less than the diameter D IS of the partially cylindrical inner side wall 120 of the housing 110, thereby defining a gap between the side wall 158 and the partially cylindrical inner side wall 120 of the housing 110.

[0105] In one or more embodiments, the locking tab 160 is a cantilevered fork having a distal portion 162 and a proximal portion 164. In one or more embodiments, the distal portion 162 is integral with the side wall 158 of the disk-shaped body 152. In one or more embodiments, the distal portion 162 and the side wall 158 of the disk-shaped body 152 can be joined together by ultrasonic welding or a solvent-resistant biocompatible adhesive. In a preferred embodiment, the distal portion 162 is at an obtuse angle relative to the proximal surface 156 of the disk-shaped body 152. In one or more embodiments, the distal portion is at a right angle or an acute angle relative to the proximal surface 156 of the disk-shaped body 152. In one or more embodiments, the locking tab 160, the distal portion 162, and the proximal portion, either combined or individually, bend, deflect, or elastically deform. In an exemplary embodiment, at least a portion of the locking tab 160 elastically deforms inwardly to cause an interference fit between the locking tab 160 and the corresponding medical connector.

[0106] The proximal portion 164 of the locking tab 160 further includes an outer wall 166 and an inner wall 168. The outer wall 166 of the locking tab 160 includes a recessed notch 170. The recessed notch 170 is adjacent to the proximal edge of the proximal portion 164 and extends at least partially along the length of the proximal portion 164 in the distal direction. In one or more embodiments, the recessed notch 170 is adjacent to the outer wall 166 relative to the outer wall 166 and adjacent to the side edge or the right edge of the outer wall 166. In one or more embodiments, the recessed notch 170 is adjacent to the outer wall 166 relative to the outer wall 166 and adjacent to the inner edge or the left edge of the outer wall 166.

[0107] In one or more embodiments, when the corresponding medical connector is advanced distally into the housing 110 by screwing the corresponding medical connector along a right-angle direction or a lateral-angle direction in accordance with the ISO 80369-7:2016 standard, the recessed notch 170 is disposed on the lateral edge or the right edge of the outer wall 166 relative to the outer wall 166. In one or more embodiments, when the corresponding medical connector is advanced distally into the housing 110 by screwing the corresponding medical connector along a left-angle direction, the recessed notch 170 is disposed on the inner edge or the left edge of the outer wall 166 relative to the outer wall 166. Figure 2A and Figure 2B The depicted embodiment of and shows a recessed notch 170 disposed on the lateral edge or the right edge of the outer wall 166 relative to the outer wall 166. In one or more embodiments of the present disclosure, the recessed notch 170 is rectangular. In one or more alternative embodiments of the present disclosure, the recessed notch may also be semi-circular, semi-elliptical, triangular, or any other geometric shape.

[0108] At least one thread 172 is disposed on the inner wall 168 of the locking tab 160. In a preferred embodiment, at least one thread 172 has a helical shape. The helical shape is substantially tapered from one direction to another direction. In one or more embodiments, the tapered portion decreases from a right direction or a lateral direction to an inner direction or a left direction relative to the outer wall 166.

[0109] In one or more embodiments, when the corresponding medical connector is advanced distally into the housing 110 by screwing the corresponding medical connector along a clockwise angle direction, a right-angle direction, or a lateral-angle direction in accordance with the ISO 80369-7:2016 standard, the tapered portion decreases from a left direction or an inner direction relative to the outer wall 166. In one or more embodiments, when the corresponding medical connector is advanced distally into the housing 110 by screwing the corresponding medical connector along a counterclockwise angle direction or a left-angle direction, the tapered portion decreases from a right direction or a lateral direction relative to the outer wall 166. Figure 2A and Figure 2B The depicted embodiment of and shows the tapered portion decreasing from a left direction or an inner direction relative to the outer wall 166.

[0110] In one or more embodiments, the corresponding medical connector is first advanced distally partially into the housing 110 until the Luer end of the corresponding medical connector abuts the proximal surface 154 of the disc 152. In one or more embodiments, the corresponding medical connector is first advanced distally partially into the housing 110 until the threads of the corresponding medical connector abut at least one of the threads 172. In one or more embodiments, the advancement of the corresponding medical connector into the housing 110 causes the advancement of the disc 152 into the housing body 110. The corresponding medical connector can then be rotated, which results in the locking of the disc 152 and the final advancement of the disc into the housing 100.

[0111] As Figure 3 shown, a third aspect of the present disclosure relates to a locking structure disposed within the cavity 130 of the housing 110, the locking structure having features provided or integral with the radial sidewall 182 of the housing 110. The locking structure includes an outwardly inclined surface 184 that slopes outwardly from an inner or left position to a side or right position. In the depicted embodiment, the outwardly inclined surface 184 extends at least partially along the length of the arc of the radial sidewall 182. In one or more embodiments, the outwardly inclined surface 184 extends along the entire length of the arc of the radial sidewall 182. An inclined tab 186 extends from a side portion of the outwardly inclined surface 184. The inclined tab 186 slopes outwardly from a side or right position to an inner or left position. The inclined tab 186 includes a ledge 188 formed by a wall that is substantially perpendicular to the radial sidewall 182. In one or more embodiments, a proximally inclined surface 190 is adjacent to the ledge 188 and slopes inwardly relative to the radial sidewall 182 from a distal position to a proximal position.

[0112] As Figure 3 shown, the inner or left portion of the radial sidewall 182 is substantially smooth, without protrusions or indentations, and the side or right portion of the radial sidewall 182 includes the outwardly inclined surface 184, the inclined tab 186, the ledge 188, and the proximally inclined surface 190. As used herein, a first position 192 is defined by the inner or left portion of the radial sidewall 182, and a locking position 194 is defined by the inclined tab 186 and the ledge 188. As Figure 4As shown, when the insert 150 is advanced distally into the cavity 130 of the housing 110, the locking tab 160 is disposed in the first position 192. In one or more embodiments, advancement of the insert 150 into the cavity 130 causes the locking tab to elastically deform outward relative to the radial sidewall 182. In the case where the insert 150 is fully advanced into the cavity 130, the insert 150 can freely rotate along the arc of the radial sidewall 182. As the insert 150 approaches the locking position 194, the outwardly inclined surface 184 further elastically deforms the locking tab 160 until the recessed notch 170 passes over the ledge 188 of the radial sidewall 182. When the recessed notch 170 has passed over the ledge 188, the recessed notch irreversibly engages the ledge 188, thereby preventing inward or leftward movement of the locking tab 160.

[0113] In some embodiments, when the recessed notch 170 has passed over the ledge 188, an audible click or sound is generated and detectable by a clinician or an auxiliary detection system to indicate that the insert 150 and thus the needleless connector has reached the fully locked position.

[0114] Figure 5 and Figure 6 Perspective views of the insert 150 in the first position 192 and the locking position 194 are shown, respectively. Similarly, Figure 7 and Figure 8 Top views of the insert 150 in the first position 192 and the locking position 194 are shown, respectively. As Figure 7 and Figure 8 depicted, due to the outwardly inclined surface 184, the thickness of the radial sidewall 182 gradually increases from a value of T1 to a value of T2.

[0115] Figure 9Depicts a partial cross-sectional view of the cavity 130, where the insert 150 is fully advanced into the cavity 130 and is in the first position 192. For illustrative purposes, the distal surface 154 of the disc 152 directly abuts the inner top surface 122 of the housing 110. However, in one or more embodiments, an absorbent material 199 containing a disinfectant is disposed between the distal surface 154 of the disc 152 and the inner top surface 122 of the housing 110. The advancement of the corresponding medical connector 150 into the cavity 130 compresses the absorbent material 199, thereby releasing the disinfectant. In one or more embodiments, the closed end 112 includes concentric retaining tabs 124 that mechanically lock onto the orifice 153 of the disc 152, thereby preventing removal of the insert 150. In one or more embodiments, the concentric retaining tabs include a distal cylinder and a proximal cylinder, and the proximal cylinder has a larger diameter than the distal cylinder. In one or more embodiments, the diameter of the proximal cylinder is greater than the diameter of the orifice 153 of the disc 152, thereby creating a snap-fit connection between the retaining tab 124 and the orifice 153 of the disc 152.

[0116] In one or more embodiments, the retaining tab 124 is long enough to allow a cylindrical absorbent material disc having an orifice extending therethrough to be placed between the disc 150 and the inner top surface 122 of the housing 110. The total length of the retaining tab 124 is equal to or slightly greater than the thickness of the disc 150 and the thickness of the cylindrical absorbent material disc, whereby the cylindrical absorbent material disc is in an uncompressed state. Insertion of the connector compresses the cylindrical absorbent material disc, thereby releasing the disinfectant into the cavity 130.

[0117] As Figure 11 and Figure 12 shown, the corresponding medical connector is the female needleless connector 80.

[0118] As Figure 11 shown, in one or more embodiments, the absorbent material 199 is placed in the cavity 130, and the absorbent material 199 abuts the proximal surface 156 of the disc 150. Insertion of the female needleless connector 80 compresses the absorbent material 199, thereby releasing the disinfectant into the cavity 130. At least one thread 82 of the connector 80 engages at least one thread 172 of the insert 150. At least one thread 82 is provided on the ferrule 84 of the female needleless connector 80.

[0119] As Figure 12As shown, in operation, the female connector 80 having at least one thread 82 engages at least one thread 172 of the insert 150, causing the female connector 80 and the insert 150 to be advanced into the housing 110. As the locking tab 160 is irreversibly locked into the second position and the absorbent material 199 (not shown for clarity) is compressed, the disinfectant is released into the cavity 130. In an embodiment where the absorbent material 199 is disposed against the closed distal end 112 of the housing 100, the released disinfectant is discharged through the gap 123 formed between the disc-shaped body 152 and the partially cylindrical inner sidewall 120. After disinfection is complete, the female connector 80 is unscrewed in the opposite direction, allowing the female connector 80 to be released while the ledge 188 engaged in the recessed notch 170 prevents removal of the insert 150. Figure 10 The elastic deformations of the locking tab 160 in the first position 192 and the locked position 194 are depicted, respectively. This deformation causes the at least one thread 172 to engage more firmly with the at least one thread of the female connector 80. For illustrative purposes, the locking tab 160 in the first position 192 is depicted directly above the locking tab 160 in the locked position. The deformation of the locking tab 160 is shown with respect to line AA, where the locking tab 160 deforms inwardly.

[0120] A second embodiment of the present disclosure relates to the housing 210 of the syringe 200. As Figures 13A to 13D shown, the housing 210 projects in the distal direction from the distal sidewall 212 of the syringe barrel 213 of the syringe 200. As Figure 13A shown, the housing 210 of the second embodiment is configured to receive a needleless connector that is typically associated with a VAD. The housing 210 includes a cavity 230 defined by the distal sidewall 212 of the syringe barrel 213, an open end 214 opposite the distal sidewall 212, and a partially cylindrical sidewall 216 extending from the distal sidewall 212 to the open end 214. A tapered ferrule 232 is disposed within the cavity 230, and the tapered ferrule 232 extends in the distal direction from the distal sidewall 212 of the syringe barrel 213. The tapered ferrule 232 is configured to interleave with a corresponding cavity (not shown) of the housing of the VAD. In some embodiments, the tapered ferrule 232 is configured to form a liquid-impermeable seal with the housing of the VAD. In some embodiments, the tapered ferrule 232 is configured to produce an interference fit with the housing of the VAD.

[0121] The housing 210 and the partially cylindrical sidewall 216 have a partially cylindrical shape, and the partially cylindrical sidewall 216 has an integrally radially protruding portion 280 extending outwardly from the housing 210. The radially protruding portion 280 defines a radial sidewall 282, and the radial sidewall 282 includes a locking structure described in more detail below. The radially protruding portion 280 and the radial sidewall 282 are in the shape of an outwardly protruding arc. The range of the angle of the protruding arc is from 10 degrees to 350 degrees.

[0122] In one or more embodiments, the partially cylindrical inner sidewall 216 has a substantially constant diameter. In one or more embodiments, the partially cylindrical inner sidewall 216 may include an outwardly tapered portion, where the tapered portion increases distally toward the open end 214.

[0123] The housing 210 further includes an outer sidewall 216. The outer sidewall 216 in the depicted embodiment has a partially cylindrical shape, which includes a smooth surface and a chamfer 218. In one or more embodiments, the chamfer 218 may be rounded. In one or more embodiments, the chamfer 218 may extend partially around the distal end of the outer sidewall 216.

[0124] As Figures 13B to 13D best shown, a locking structure is disposed within the cavity 230 of the housing 210, and the locking structure has features integral with the radial sidewall 282 of the housing 210. The locking structure includes an outwardly inclined surface 284 that is inclined outwardly from an inner or left position to a side or right position. In the depicted embodiment, the outwardly inclined surface 284 extends at least partially along the arc length of the radial sidewall 282. In one or more embodiments, the outwardly inclined surface 284 extends along the entire arc length of the radial sidewall 282. An inclined tab 286 extends from the side portion of the outwardly inclined surface 284. The inclined tab 286 is inclined outwardly from a side or right position to an inner or left position. The inclined tab 286 includes a ledge 288 formed by a wall that is substantially perpendicular to the radial sidewall 282. In one or more embodiments, a proximally inclined surface 290 is adjacent to the ledge 288, and the proximally inclined surface 290 is inclined inwardly relative to the radial sidewall 282 from a distal position to a proximal position.

[0125] As Figure 13C and Figure 13DAs best shown, the inner or left portion of the radial sidewall 282 is substantially smooth, without protrusions or indentations, and the side or right portion of the radial sidewall 282 includes an outwardly inclined surface 284, an inclined tab 286, a ledge 288, and a proximally inclined surface 290. As used herein, the first position 292 is defined by the inner or left portion of the radial sidewall 282 and the locking position 294 is defined by the inclined tab 286 and the ledge 288.

[0126] As Figure 14A and Figure 14B shown in FIG. 7, the insert 250 has a substantially disc-shaped body 252 having a proximal surface 254, a distal surface 256, and a sidewall 258. A locking tab 260 extends from the sidewall 258, the locking tab 260 extending in a distal direction away from the distal surface 256 of the disc-shaped body 252. In one or more embodiments, the disc-shaped body 252 includes an aperture 253 disposed on the proximal surface 254 of the disc-shaped body 252, the aperture 253 extending through the proximal surface. The center of the aperture 253 is concentric with the center of the disc-shaped body 252. The disc-shaped body 252 has a diameter D DB , the diameter D DB being less than the diameter D of the partially cylindrical inner sidewall 220 of the housing 210, thereby defining a gap between the sidewall 258 and the partially cylindrical inner sidewall 220 of the housing 210. IS

[0127] In one or more embodiments, the locking tab 260 is configured as a cantilevered fork having a proximal portion 262 and a distal portion 264. In one or more embodiments, the proximal portion 262 is integral with the sidewall 258 of the disc-shaped body 252. In one or more embodiments, the proximal portion 262 and the sidewall 258 of the disc-shaped body 252 may be joined together by ultrasonic welding or a solvent-resistant biocompatible adhesive. In a preferred embodiment, the proximal portion 262 is at an obtuse angle relative to the distal surface 256 of the disc-shaped body 252. In one or more embodiments, the proximal portion 262 is at a right angle or an acute angle relative to the distal surface 256 of the disc-shaped body 252. In one or more embodiments, the locking tab 260, the proximal portion 262, and the distal portion, either combinatorially or individually, bend, deflect, or elastically deform. In an exemplary embodiment, at least a portion of the locking tab 260 elastically deforms inwardly to effect an interference fit between the locking tab 260 and the corresponding medical connector.

[0128] The proximal portion 264 of the locking tab 260 further includes an outer wall 266 and an inner wall 268. The outer wall 266 of the locking tab 260 includes a recessed notch 270. The recessed notch 270 is adjacent to the distal edge of the distal portion 264 and extends at least partially along the length of the distal portion 264 in the proximal direction. In one or more embodiments, the recessed notch 270 is adjacent to the lateral or right edge of the outer wall 266 relative to the outer wall 266. In one or more embodiments, the recessed notch 270 is adjacent to the medial or left edge of the outer wall 266 relative to the outer wall 266.

[0129] As Figure 15 and Figure 16 shown, in one or more embodiments, when the VAD is advanced proximally into the housing 210 by screwing the VAD along a leftward angular direction in accordance with the ISO 80369-7:2016 standard, the recessed notch 270 is disposed on the medial or left edge of the outer wall 266 relative to the outer wall 266. In one or more embodiments, when the VAD is advanced distally into the housing 210 by screwing the VAD along a rightward angular direction, the recessed notch 270 is disposed on the medial or left edge of the outer wall 266 relative to the outer wall 266. Return reference Figure 14A and Figure 14B to the depicted embodiment, which shows a recessed notch 270 disposed on the lateral or right edge of the outer wall 266 relative to the outer wall 266. In one or more embodiments of the present disclosure, the recessed notch 270 is rectangular. In one or more alternative embodiments of the present disclosure, the recessed notch 270 may also be semi-circular, semi-elliptical, triangular, or any other geometric shape.

[0130] At least one thread 272 is disposed on the inner wall 268 of the locking tab 260. In a preferred embodiment, at least one thread 272 has a helical shape. The helical shape is generally tapered from one direction towards another direction. In one or more embodiments, the taper decreases from a rightward or lateral direction to a medial or leftward direction relative to the outer wall 266.

[0131] In one or more embodiments, when the VAD is advanced distally into the housing 210 by screwing the VAD along a clockwise angular direction, a rightward angular direction, or a lateral angular direction in accordance with the ISO 80369-7:2016 standard, the taper decreases from a leftward or medial direction relative to the outer wall 266. In one or more embodiments, when the VAD is advanced proximally into the housing 210 by screwing the VAD connector along a counterclockwise angular direction or a leftward angular direction, the taper decreases from a rightward or lateral direction relative to the outer wall 266. Figure 14A and Figure 14BThe depicted embodiment shows that the tapered portion decreases relative to the outer wall 266 from the leftward or inward direction.

[0132] As described previously with respect to the first embodiment, and as Figure 15 and Figure 16 shown, when the insert 250 is advanced proximally into the cavity 230 of the housing 210, the locking tab 260 is disposed in the first position 292. In one or more embodiments, the advancement of the insert 250 into the cavity 230 causes the locking tab to elastically deform outward relative to the radial sidewall 282. In the case where the insert 250 is fully advanced into the cavity 230, the insert 250 can freely rotate along the arc of the radial sidewall 282. As the insert 250 rotationally approaches the locking position 294, the outwardly inclined surface 284 further elastically deforms the locking tab 260 inwardly until the recessed notch 270 passes over the ledge 288 of the radial sidewall 282. When the recessed notch 270 has passed over the ledge 288, the recessed notch irreleasably engages the ledge 288, thereby preventing the inward or leftward movement of the locking tab 260.

[0133] In some embodiments, when the recessed notch 270 has passed over the ledge 288, an audible click or sound is generated and can be detected by a clinician or an auxiliary detection system to indicate that the insert 250 and thus the medical connector has reached the fully locked position.

[0134] As Figure 16 best shown, in the fully advanced position, the proximal surface 254 of the insert 250 abuts the distal sidewall 212 of the syringe barrel 213 of the syringe 200. In one or more embodiments, a circular protrusion 234 is provided on the tapered ferrule 232. The circular protrusion 234 is configured to non-removably lock the insert 250 in the fully advanced position. The circular protrusion 234 is positioned at a distance from the distal sidewall 212 of the syringe barrel 213, and this distance is configured to be equal to or slightly greater than the thickness of the disk-like body of the insert 250. In one or more embodiments, the circular protrusion 234 has a substantially triangular cross-section, the triangular cross-section having a surface that is perpendicular to the proximal side of the tapered ferrule 232 and a surface that is acute-angled with respect to the distal side of the tapered ferrule 232. The acute-angled surface on the distal side of the circular protrusion 234 is configured to cause a slight deformation of the insert 250 when the insert 250 comes into contact with the acute-angled surface on the distal side of the circular protrusion 234 as the insert 250 is advanced proximally. The proximal right-angled surface of the circular protrusion 234 is configured to non-removably fix the insert 250 when the insert 250 has completely passed through the triangular cross-section of the circular protrusion 234.

[0135] The third embodiment of the present disclosure relates to the housing 310 of the medical connector 300. Figure 17, Figure 18A and Figure 18B show a medical connector 300 in an initial unactivated state, and Figure 19 and Figure 20 show a medical connector 300 in a final activated state, where a corresponding medical connector (not shown) has been fully advanced into the cavity 330 of the housing 310.

[0136] As Figures 17 to 18B shown, the medical connector 300 includes a substantially cylindrical housing 310 having a distal wall 312, a proximal open end 314, a side wall 316 extending between the distal wall 312 and the open end 314, and a cavity 330. The cavity 330 extends from the open end 314 to the distal wall 312. In one or more embodiments, a disc-shaped absorbent material 399 is disposed within the cavity 330, abutting an inner distal surface 322 of the distal wall 312. An inner side wall surface 318 of the side wall 316 includes a channel 324 extending from the distal wall 312 to the open end 314. On the inner side wall surface 318, the channel 324 has a substantially rectangular profile, and the channel 324 extends into the side wall 316 to a certain depth. As discussed further in detail below, the depth of the channel 324 is configured to at least partially interleave with the spring 350.

[0137] The housing further includes a plurality of threads 320 disposed on the inner side wall surface 318, however the plurality of threads 320 are not disposed on the channel 324. The plurality of threads 320 are configured to threadedly engage corresponding threads 82 of a female needleless connector 80 of one of the foregoing embodiments (as Figure 11 and Figure 12 shown).

[0138] As Figures 17 to 18B shown, and as best shown in Figure 18B , the spring 350 is configured as a leaf spring having a rectangular cross-section and an arcuate portion 352. In one or more embodiments, the arcuate portion 352 has a tip, thereby forming a ramp. The arcuate portion 352 is between a distal portion 354 and a proximal portion 356. The distal portion 354 is non-removably attached to the channel 324, while the proximal portion 356 is not attached to the channel 324 and is free to deflect. In operation, as Figures 17 to 18B shown, the proximal portion 356 abuts the channel 324 in the initial state. As the needleless connector 80 is advanced into the cavity 330, at least one thread 82 presses the arcuate portion 352 of the spring 350 into the channel 324. The downward pressing of the arcuate portion 352 causes the proximal portion 354 of the spring 350 to deflect outwardly away from the channel 324. In as Figure 19 and Figure 20In the fully advanced position shown, the proximal end 355 of the proximal portion 354 of the spring 350 engages the lower segment of at least one thread 82 of the needleless connector 80, thereby locking the needleless connector 80 within the cavity 330 in a threaded fit and an interference fit. In one or more embodiments, the needleless connector 80 is removably locked within the cavity 330. In one or more embodiments, the needleless connector 80 is non-removably locked within the cavity 330 by the configuration of the spring 350 (including but not limited to using a stiffer spring).

[0139] In embodiments in which the needleless connector 80 is removable from the cavity 330, the spring 350 does not return to its initial state, thereby preventing reuse of the housing 310.

[0140] In some embodiments, when the needleless connector 80 is fully advanced into the cavity 330 and the spring 350 engages the corresponding thread 82, an audible click or sound is generated and can be detected by a clinician or an auxiliary detection system to indicate that the needleless connector 80 has been fully advanced into the cavity 330.

[0141] In some embodiments, the proximal end 355 of the spring 350 further includes a set of tabs 353 protruding from the proximal end 355. In some embodiments, the set of tabs 353 is in the form of a C-clip. In the fully advanced position, the set of tabs 353 interlocks with the threads of the corresponding needleless connector 80. The set of tabs 353 engages the threads of the needleless connector 80 to non-removably lock the corresponding needleless connector 80. In some embodiments, the set of tabs 353 is wider than the spring 350. In some embodiments, the set of tabs 353 is configured to disengage from the corresponding thread 82 and jump out of the thread path to prevent reuse.

[0142] A fourth embodiment of the present disclosure relates to the housing 410 of a medical connector 400. Figure 21A and Figure 21B shows the medical connector 400 in an initial unactivated state, and Figures 22A to 22C shows the medical connector 400 in a final activated state, where a needleless connector (not shown) has been fully advanced into the cavity 430 of the housing 410.

[0143] As Figure 21A and Figure 21BAs shown, the medical connector 400 includes a generally cylindrical housing 410 having a distal wall 412, a proximal open end 414, a side wall 416 extending between the distal wall 412 and the open end 414, and a cavity 430. The cavity 430 extends from the open end 414 to the distal wall 412. A cup spring 350 (also known in the art as a Belleville spring) is disposed within the cavity 330, wherein the open distal end 352 of the cup spring 350 abuts the inner distal surface 422 of the distal wall 412 of the housing 410.

[0144] The cup spring 450 includes a frustoconical, disc-shaped body 452 having at least two tines 456 extending from the proximal edge 454 of the disc-shaped body 452. Although generally the frustoconical shape of the disc-shaped body 452 defines the spring constant and spring characteristics, the at least two tines 456 may have different spring constants and spring characteristics relative to the disc-shaped body 452. In one or more embodiments, the at least two tines 456 have a stiffer spring constant and spring characteristics relative to the disc-shaped body 452. In one or more embodiments, the at least two tines 456 are rigid.

[0145] The at least two tines 456 extend in a proximal direction from the proximal edge 454 of the disc-shaped body 452. Each of the at least two tines 456 includes a proximal portion 458 and a distal portion 460 adjacent to the proximal portion 458. The distal portion 460 forms an inner hook 462 that extends toward the center of the disc-shaped body 452. The inner hook 562 includes an inner edge 464 configured to engage a corresponding thread 82 of a corresponding needleless luer connector 80 of one of the foregoing embodiments (as Figure 11 and Figure 12 shown). In one or more embodiments, a disc-shaped absorbent material 498 is disposed within the cavity 430. The absorbent material 498 abuts the proximal surface of the disc-shaped body 452.

[0146] Figure 21A and Figure 21B show the medical connector 400 in an initial, unactivated state, Figures 22A to 22C show the medical connector 400 in a final, activated state, wherein a needleless connector (not shown) has been fully advanced into the cavity 430 of the housing 410. In operation, a ferrule 84 of a corresponding needleless connector 80 of one of the foregoing embodiments (as Figure 11 and Figure 12 shown) is advanced into the cavity 430 of the housing 410. As the ferrule 84 contacts and advances against the disc-shaped body 452, the disc-shaped body 452 deforms from the Figure 21A and Figure 21B initial state toFigures 22A to 22C Final state. The disc-shaped body 452 deforms inwardly, thereby pushing the proximal edge 454 of the disc-shaped body 452 in the proximal direction, causing at least two fork heads 456 to advance in the proximal direction, whereby the inner hook 462 is further advanced in the lateral direction. In the final state, the inner hook 462 latches onto at least one thread 82, thereby locking the needleless connector 80 into the housing 410 due to the spring force. In as Figure 19 and Figure 20 In the fully advanced position as shown in

[0147] In embodiments where the needleless connector 80 is removed from the cavity 330, the spring 450 does not return to its initial state, thereby preventing reuse of the housing 310.

[0148] As Figures 22A to 22C shown, in some embodiments, when the needleless connector 80 is fully advanced into the cavity 430 and the spring 450 engages the corresponding thread 82, an audible click or sound is generated and can be detected by a clinician or an auxiliary detection system to indicate that the needleless connector 80 has been fully advanced into the cavity 430.

[0149] As Figure 22A shown, in some embodiments, the inner hook 462 further includes a set of tabs 453 protruding from the inner hook 462. In some embodiments, the set of tabs 453 is in the form of a C-shaped clip. In the fully advanced position, the set of tabs 453 interlocks with the threads of the corresponding needleless connector 80. The set of tabs 653 engages the threads of the needleless connector 80 to irreversibly lock the corresponding needleless connector 80. In some embodiments, the set of tabs 353 is wider than the spring 350. In some embodiments, the set of tabs 353 is configured to disengage from the corresponding thread 82 and jump out of the thread path to prevent reuse.

[0150] As Figure 22B andFigure 22C As shown in Figure 22C , in some embodiments, the inner edge 464 is elongated in the lateral and medial directions. In some embodiments, the inner edge 464 is configured as a C-clamp. In the fully advanced position, the inner edge 464 is threadedly interlocked with the corresponding needleless connector 80. The elongated inner edge 464 engages the threads of the needleless connector 80 to non-removably lock the corresponding needleless connector 80. In some embodiments, the inner edge 464 is wider than the spring 350. In some embodiments, the inner edge 464 is configured to disengage from the corresponding threads 82 and jump out of the thread path to prevent reuse.

[0151] The fifth embodiment of the present disclosure relates to the housing 510 of the medical connector 500. Figure 23A and Figure 23B show the medical connector 500 in an initial unactivated state, Figure 24A and Figure 24B show the medical connector 500 in a final activated state, where a needleless connector (not shown) has been fully advanced into the cavity 530 of the housing 510. In the final state, the needleless connector is removable, but the medical connector 500 has an integrated feature that prevents reuse of the medical connector 500, as further explained in detail below.

[0152] The medical connector 500 includes a substantially cylindrical housing 510 having a distal wall 512, a proximal open end 514, a side wall 516 extending between the distal wall 512 and the open end 514, and a cavity 530. The cavity 530 extends from the open end 514 to the distal wall 512. At least one helical thread 550 is provided on the inner side wall 518 of the cavity 530, and the helical thread 550 extends at least partially along the length of the inner side wall 518.

[0153] At least one helical thread 550 includes a distal portion 552 integrally formed on the inner side wall 518 and a frangible portion 554 proximal to the distal portion. The frangible portion is configured to separate and disengage when the corresponding thread 82 of the corresponding needleless luer connector 80 of one of the foregoing embodiments (as shown in Figure 11 and Figure 12 ) is screwed and advanced into the cavity. When the luer connector 80 is removed, the frangible portion 554 does not return to its initial state, thereby preventing reuse of the housing 510. Figure 11 and Figure 12 As shown. When the luer connector 80 is removed, the frangible portion 554 does not return to its initial state, thereby preventing reuse of the housing 510.

[0154] In one or more embodiments, as shown in Figure 23B , the frangible portion 554 in the initial state does not follow the thread pattern of at least one helical thread 550. In one or more embodiments, as shown in Figure 23B , the frangible portion 554 has a closer angle than the distal portion 552 of at least one helical thread 550. Figure 23B As shown in Figure 23B , in the initial state, the frangible portion 554 does not follow the thread pattern of at least one helical thread 550. In one or more embodiments, as shown in Figure 23B , the frangible portion 554 has a closer angle than the distal portion 552 of at least one helical thread 550. Figure 23B As shown in Figure 23B , the frangible portion 554 has a closer angle than the distal portion 552 of at least one helical thread 550. A greater approach angle Φ. The greater approach angle Φ is configured to cause deformation of the frangible portion 554. Due to the thread misalignment, the deformation of the frangible portion 554 prevents the re-use of the needleless connector 500. The removal of the corresponding needleless Luer connector 80 does not restore the frangible portion 554 to its original angle Φ of the frangible portion 554, and thus the medical connector 500 cannot be re-used. Specifically, as Figure 24B shown, the insertion and subsequent removal of the corresponding needleless Luer connector 80 causes the frangible portion 554 to have an approach angle close to zero, whereby the frangible portion 554 is substantially parallel to the inner distal surface 522 of the housing 510.

[0155] In one or more embodiments, and as Figure 23B specifically shown, the frangible portion 554 extends a quarter turn. In one or more embodiments, the frangible portion 554 extends a half turn. In one or more embodiments, the frangible portion 554 extends three-quarters of a turn.

[0156] In one or more embodiments, an absorbent material 599 is placed in the cavity 530, and the absorbent material 599 abuts the inner distal surface 522 of the housing 510. The insertion of the corresponding needleless connector 80 compresses the absorbent material 599, thereby releasing a disinfectant into the cavity 530.

[0157] The sixth embodiment of the present disclosure relates to an insert 650 disposed within a housing 610 of a medical connector 600. Figure 25A And Figure 25B shows an embodiment of the insert 650, and Figure 26 shows the medical connector 600 in an initial unactivated state. In a final activated state, as described in further detail below, a needleless connector (not shown) is fully advanced into the cavity 630 of the housing 610.

[0158] As Figure 25A and Figure 25B shown, the insert 650 has a substantially disc-shaped body 652 having a proximal surface 654 and a distal surface 656. At least two locking tabs 660 extend from the proximal surface 654, and the at least two locking tabs 660 extend in a distal direction away from the distal surface 656 of the disc-shaped body 652. Each of the at least two locking tabs 660 includes a hooked proximal end 662. The hooked proximal end 662 is configured to interlock with the corresponding thread 82 of the corresponding needleless Luer connector 80 of one of the previous embodiments (as Figure 11 and Figure 12 shown) when the corresponding thread of the corresponding needleless Luer connector is screwed and advanced into the cavity.

[0159] In one or more embodiments, the disc-shaped body 652 further includes an aperture 653 disposed on the proximal surface 654 of the disc-shaped body 652, the aperture 653 extending through the proximal surface. The center of the aperture 653 is concentric with the center of the disc-shaped body 652. As Figure 26 shown and further explained in detail below, the aperture 653 is configured to non-removably interlock with the hook-shaped protrusion 640 of the housing 610.

[0160] In one or more embodiments, the disc-shaped body 652 further includes a plurality of ridges 672 disposed on the side wall 670 of the disc-shaped body 652. The plurality of ridges 672 extend from the side wall 670 of the disc-shaped body 652 in an inward direction into the disc-shaped body 652. As Figure 26 shown and further explained in detail below, the plurality of ridges 672 are configured to interleave with at least one toothed member 634 of the housing 610.

[0161] In one or more embodiments, as Figure 25B shown, the disc-shaped body 652 further includes a movable hinge 676 disposed across the disc-shaped body 652. As Figure 26 shown, the movable hinge 676 is configured to bend the disc-shaped body 652. Bending of the disc-shaped body 652 causes at least two locking tabs 660 to engage the threads of the medical connector.

[0162] As Figure 26 shown, the medical connector 600 includes a substantially cylindrical housing 610 having a distal wall 612, a proximal open end 614, a side wall 616 extending between the distal wall 612 and the open end 614, and a cavity 630. The cavity 630 extends from the open end 614 to the distal wall 612. In one or more embodiments, a disc-shaped absorbent material (not shown) is disposed within the cavity 630, abutting the inner distal surface 622 of the distal wall 612.

[0163] In one or more embodiments, the hook-shaped protrusion 640 extends concentrically from the inner distal surface 622 of the housing 610. The hook-shaped protrusion 640 is configured to non-removably interlock with the aperture 653 of the disc-shaped body 652 when the disc-shaped body 652 is fully advanced into the cavity 630 of the housing 610, thereby preventing reuse of the medical connector 600.

[0164] In one or more embodiments, at least one toothed member 634 extends medially from the inner sidewall 618 into the cavity 630. The at least one toothed member 634 is positioned at a distance from the inner distal surface 622 of the housing 610. In one or more embodiments, the at least one toothed member 634 is positioned substantially parallel to the proximal end 641 of the hooked projection 640. The at least one toothed member 634 and the plurality of ridges 672 of the disc-shaped body 652 are configured to interleave with each other, wherein the at least one toothed member 634 and the plurality of ridges 672 have substantially corresponding shapes. In one or more embodiments, the at least one toothed member 634 has a substantially triangular shape and the plurality of ridges 672 have a corresponding triangular profile. In one or more embodiments, at least one ledge 637 is provided on the inner distal surface 622 of the housing 610.

[0165] As Figure 26 shown, the medical connector 600 is in an initial position. When the corresponding needleless Luer connector 80 is fully advanced, the hooked projection 640 is received within the orifice 653 of the disc-shaped body 652. However, misalignment of the plurality of ridges 672 and the at least one toothed member 634 inhibits full advancement. Thus, full advancement can occur when the plurality of ridges 672 are aligned with the at least one toothed member 634. In the final state, the insert 650 is non-removably locked since the hooked projection 640 is received within the orifice 653 of the disc-shaped body 652.

[0166] In one or more embodiments, absorbent material (not shown) is placed within the cavity 630, the absorbent material abutting the inner distal surface 622 of the housing 610. Insertion of the corresponding needleless connector 80 compresses the absorbent material, thereby releasing a disinfectant into the cavity 630.

[0167] As Figure 27 shown, a seventh embodiment of the present disclosure relates to a medical connector 700 that includes a housing 710 and an insert 750 disposed within the housing 710. As further explained in detail below, the insert 750 is an elastic and flexible material and includes at least two active hinges 760 to grip onto the threads 82 of a corresponding needleless Luer connector 80 of one of the foregoing embodiments (as Figure 11 and Figure 12 shown).

[0168] The housing 710 has a generally cylindrical shape and includes a distal wall 712, a proximal open end 714, a side wall 716 extending between the distal wall 712 and the open end 714, and a cavity 730. The cavity 730 extends from the open end 714 to the distal end 712. In one or more embodiments, a disc-shaped absorbent material (not shown) is disposed within the cavity 730, abutting the inner distal surface 722 of the housing 710. In one or more embodiments, the distal end 712 of the housing 710 is in the shape of an inward-facing hook.

[0169] The insert 750 includes a C-shaped body 752 having an arcuate distal end 754 and an open proximal end 756. Two movable hinges 760 extend from the distal end 754. The two movable hinges 760 are in the form of cantilevered fork heads. As the corresponding needleless luer connector 80 is advanced into the cavity 730, the C-shaped body 752 including the distal end 754 and the movable hinges 760 deflects. The elastic material of the insert 750 causes the corresponding needleless luer connector 80 to be held by the open proximal end 756 of the insert 750. The two movable hinges 760 provide a reaction force relative to the C-shaped body 752 of the insert.

[0170] In one or more embodiments, an absorbent material (not shown) is placed within the cavity 730, the absorbent material abutting the inner distal surface 722 of the housing 510. Insertion of the corresponding needleless connector 80 compresses the absorbent material, thereby releasing a disinfectant into the cavity 730.

[0171] As Figure 28A and Figure 28B shown, the eighth embodiment of the present disclosure relates to a medical connector 800 that includes a housing 810 and an insert 850 disposed within the housing 810. As further explained in detail below, the insert 850 is of an elastic and flexible material and includes at least two movable hinges 860 to grip onto the threads 82 of a corresponding needleless luer connector 80 of one of the foregoing embodiments (as Figure 11 and Figure 12 shown).

[0172] The housing 810 has a generally cylindrical shape and includes a distal wall 812, a proximal open end 814, a side wall 816 extending between the distal wall 812 and the open end 814, and a cavity 830. The cavity 830 extends from the open end 814 to the distal wall 812. In one or more embodiments, a disc-shaped absorbent material (not shown) is disposed within the cavity 830, abutting the inner distal surface 822 of the distal wall 812. In one or more embodiments, the distal wall 812 further projects in an inward direction.

[0173] In one or more embodiments, the protrusion 840 extends concentrically from the inner distal surface 822 of the housing 810. The protrusion 840 is configured to non-removably interlock with the orifice 853 of the C-shaped body 852 when the C-shaped body 852 is fully advanced into the cavity 830 of the housing 810, thereby preventing reuse of the needleless connector 800. The protrusion 840 is configured to assist in aligning and advancing the insert 850 into the cavity 830 of the housing 810.

[0174] In one or more embodiments, the inner wall 823 is positioned at a distance from the inner distal surface 822 of the housing 810. The inner wall 823 further includes an orifice 824 configured to receive the distal portion 854 of the insert 850, which is further explained in detail below.

[0175] The insert 850 includes a C-shaped body 852 having an arcuate distal portion 854 and an open proximal end 856. At least two active hinges 860 extend tangentially from the distal portion 854. The two active hinges 860 are in the form of cantilever forks. As the corresponding needleless luer connector 80 is advanced into the cavity 830, the C-shaped body 852 including the distal portion 854 and the at least two active hinges 860 deflects. The elastic material of the insert 850 causes the corresponding needleless luer connector 80 to be held by the open proximal end 856 of the insert 850. The two active hinges 860 provide a reaction force relative to the C-shaped body 852 of the insert.

[0176] In one or more embodiments, the C-shaped body 852 further includes a stem 857 having a cylindrical profile extending in a distal direction from the distal portion 854. A bulbous protrusion 859 extends from the stem. The C-shaped body 852, the stem 857, and the bulbous protrusion 859 form a single body through which an orifice 861 extends. The orifice 861 is configured to receive the protrusion 840 of the housing 810, while the stem 857 and the bulbous protrusion 859 are configured to interlock with the orifice 824 of the housing 810.

[0177] As the corresponding needleless luer connector 80 is advanced into the cavity 830, the C-shaped body 852 including the distal portion 854 and the active hinges 860 deflects. The elastic material of the insert 850 causes the corresponding needleless luer connector 80 to be held by the open proximal end 856 of the insert 850. The two active hinges 860 provide a reaction force relative to the C-shaped body 852 of the insert.

[0178] In one or more embodiments, absorbent material (not shown) is placed in the cavity 830 and abuts the inner wall 823 of the housing 510. Insertion of the corresponding needleless connector 80 compresses the absorbent material, thereby releasing a disinfectant into the cavity 830.

[0179] In one or more embodiments, the corresponding medical connector can be selected from the group consisting essentially of needleless connectors, catheter Luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the needleless connectors are selected from Q-Syte connectors, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0180] In one or more embodiments, the male connector can be an intravenous tube end, a stopcock, or a male lock Luer.

[0181] In some embodiments, the connector includes a needleless injection site, which can sometimes be referred to as a needleless injection port, ferrule, valve, or device, or as a needleless access site, port, ferrule, valve, or device, and which can include brands such as (available from ICU Medical, Inc.), (available from Cardinal Health, Inc.) and Q-Syte TM (available from Becton, Dickinson and Company). In some embodiments, the needleless connector can be connected to any one of a variety of different needleless injection sites (such as those listed previously). In one or more embodiments, after the needleless connector has been coupled to the connector, it is not necessary to disinfect the connector (e.g., treat it with an alcohol wipe) before reconnecting the connector to another connector each time, because the connector will remain uncontaminated while coupled to the needleless connector. The use of the needleless connector replaces the standard wiping protocol for cleaning the connector.

[0182] Such connectors are typically and commonly used in medical applications as catheters and other liquid-impervious protective connectors. In one or more embodiments, when a threaded engagement medical connector (100, 200, 300, 400, 500, 600, 700, 800) from a corresponding needleless Luer connector is engaged therewith and forms a releasable connection, the medical connector (100, 200, 300, 400, 500, 600, 700, 800) provides a protective cover for the corresponding needleless Luer connector when engaged with the connector.

[0183] The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) are made of any one of a variety of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the medical connectors (100, 200, 300, 400, 500, 600, 700, 800) comprise a polypropylene or polyethylene material.

[0184] The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) can be disinfected when used on a Luer connector by integrating a disinfectant in the cavities (130, 230, 330, 430, 530, 630, 730, 830). The disinfectant or antimicrobial agent can be directly included in the absorbent material, or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam material that fills the cavities (130, 230, 330, 430, 530, 630, 730, 830). The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) are designed to be compatible in interaction with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include variants of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent 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, tert-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In a particular embodiment, the disinfectant or antimicrobial agent includes 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.

[0185] In one or more embodiments, the absorbent material is a nonwoven material, a foam, or a sponge. In a particular embodiment, the absorbent material is a polyethylene foam. The foam can be open-cell, semi-open-cell, or closed-cell, and can be molded or extruded or die-cut from a sheet. In one or more embodiments, the absorbent storage material is molded or extruded or die-cut from a sheet to form a cylindrical block.

[0186] The peelable seal minimizes potential particulate hazards and also provides a substantially impermeable housing for medical connectors (100, 200, 300, 400, 500, 600, 700, 800), provides a leak-proof and protective housing, protects the contents of the absorbent material contained within the cavities (130, 230, 330, 430, 530, 630, 730, 830), and / or maintains a sealed sterile environment. The peelable seal provides sufficient sealing over a range of temperature, pressure, and humidity levels. In one or more embodiments, the peelable seal comprises an aluminum or multi-layer polymer film peel top liner. In a particular embodiment, the peelable seal is heat-sealed or induction-sealed to the end face of a locking cap or the open end of a needleless connector. In one or more embodiments, the peelable seal comprises a moisture barrier.

[0187] In some embodiments, the medical connector is configured as a cap that contains a disinfectant within a cavity of the housing and is capable of occluding the lumen of a corresponding medical connector to minimize entry of the disinfectant and microbial agents into the connector, thereby reducing the risk of entry of the disinfectant and microbial agents into the patient's bloodstream.

[0188] Although the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, 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 the present disclosure. For example, the disinfection sponge may comprise any suitable disinfecting or other application-specific substance and may be made of any suitable material. Additionally, the inner housing and / or outer housing of the medical connector may be injection molded in a single piece or may be made by other suitable processes. Further, as will be readily understood by those skilled in the art, without departing from the spirit and scope of the embodiments of the present disclosure, any feature or element of any exemplary embodiment of the present disclosure as described above and shown in the drawings may be implemented individually or in any combination (one or more).

[0189] In addition, the included drawings further depict non-limiting examples of the implementation of certain exemplary embodiments of the present disclosure and assist in describing the technology associated therewith. Except as noted above, any specific or relative dimensions or measurements provided in the drawings are exemplary and are not intended to be limiting.

[0190] 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 described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of phrases such as "in one or more embodiments", "in certain embodiments", "in one embodiment", or "in an embodiment" throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0191] Although the present disclosure has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatuses of the present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A medical connector, the medical connector comprising: a housing having a substantially cylindrical housing body, the substantially cylindrical housing body having a radially protruding portion extending from the substantially cylindrical housing body and a cavity defined by a distal closed end, a proximal open end, a partially cylindrical inner sidewall of the substantially cylindrical housing body, and a radially inner sidewall of the radially protruding portion, the radially inner sidewall of the radially protruding portion having a larger diameter than the partially cylindrical inner sidewall of the substantially cylindrical housing body; a locking structure disposed on a rightward portion of the radially inner sidewall of the radially protruding portion, the locking structure including an inclined tab; and an insert capable of being advanced into the cavity of the housing, the insert including a disc-shaped body having a distal surface, a proximal surface, a sidewall, and a locking tab extending proximally from the sidewall, the insert including at least one thread on an inner wall of the locking tab and a recessed notch provided on a proximal portion of an outer wall of the locking tab.

2. The medical connector according to claim 1, wherein The insert rotates from a first position defined by a leftward portion of the radially inner sidewall to a locking position defined by the rightward portion.

3. The medical connector according to claim 1, wherein, When the recessed notch is advanced past the inclined tab, the recessed notch of the insert engages a ledge of the inclined tab of the locking structure.

4. The medical connector according to claim 3, wherein, A sound is generated when the recessed notch is advanced past the ledge of the inclined tab.

5. The medical connector according to claim 1, wherein, The locking structure further includes an outwardly inclined surface that is outwardly inclined from a leftward position to a rightward position.

6. The medical connector according to claim 5, wherein, The outwardly inclined surface causes the locking tab to deform.

7. The medical connector according to claim 1, wherein, The locking structure further includes a proximally inclined surface positioned adjacent to the ledge of the inclined tab, the proximally inclined surface being inwardly inclined relative to the radially inner sidewall from a distal position to a proximal position.

8. The medical connector according to claim 1, wherein, When the insert is fully advanced into the cavity, a distal surface of the insert abuts an inner top surface of the cavity of the housing.

9. The medical connector according to claim 1, wherein, When the insert is fully advanced into the cavity, an absorbent material is disposed between the distal surface of the insert and the inner top surface of the cavity of the housing, the absorbent material containing a disinfectant.

10. The medical connector according to claim 9, wherein, Fully advancing the insert into the cavity in a distal direction causes the distal surface of the insert and the inner top surface of the cavity of the housing to compress the absorbent material, whereby the absorbent material releases the disinfectant.

11. The medical connector according to claim 10, wherein, The disinfectant is discharged into the cavity through a gap defined by the partially cylindrical inner sidewall of the housing and the sidewall of the insert.

12. The medical connector according to claim 1, wherein, The partially cylindrical inner sidewall of the housing has a larger diameter than the sidewall of the insert.

13. The medical connector according to claim 1, wherein, A retaining tab is disposed on the inner top surface of the housing, the inner top surface non-removably fixing an orifice provided on the distal surface of the insert, the orifice extending through the distal surface.

14. The medical connector according to claim 4, wherein, The sound is an audible click.

15. A medical connector, the medical connector comprising: a housing having a substantially cylindrical housing body with a radially projecting portion extending from the substantially cylindrical housing body and a cavity defined by a distal closed end, a proximal open end, a partially cylindrical inner sidewall of the substantially cylindrical housing body, and a radially inner sidewall of the radially projecting portion, the radially inner sidewall of the radially projecting portion having a greater diameter than the partially cylindrical inner sidewall of the substantially cylindrical housing body; a locking structure disposed on a rightward portion of the radially inner sidewall of the radially projecting portion, the locking structure including an inclined tab; and an insert that can be advanced into the cavity of the housing, the insert including a disc-shaped body having a distal surface, a proximal surface, a sidewall, and a locking tab extending proximally from the sidewall, the insert including at least one thread located on an inner wall of the locking tab and a recessed notch provided on a proximal portion of an outer wall of the locking tab, wherein screwing a corresponding medical connector into the cavity causes the insert to be advanced into the cavity, the corresponding medical connector having at least one thread to engage the at least one thread of the insert.

16. The medical connector according to claim 15, wherein, The corresponding medical connector is removably screwed into the cavity.

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