Disinfection cap with anti-reuse function

Abstract

A medical connector for connecting to a corresponding medical connector is described. The medical connector includes a housing having a radial protrusion and a cavity, the cavity being defined by a closed end, an open end, a partial cylindrical sidewall, and a radial sidewall. 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. The at least one thread of the locking tab engages with 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, the second position including a locking structure for removably securing the insert to the housing while allowing removal of the corresponding medical connector.

Description

[Technical Field]

[0001] The present disclosure relates generally to medical connectors, and more particularly to mating elements of medical connectors that are reusable and disinfectable. [Background technology]

[0002] Vascular access devices (VADs) are common therapeutic devices and include intravenous (IV) catheters. VADs are broadly divided into two types: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system through the access hub and ports / valves when connected to a VAD to deliver fluids or medications to the patient. Access hubs, fittings, ports, and valves are associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

[0003] Standards of practice, including disinfection and cleaning procedures, have been developed to reduce the incidence of CRBSI and ensure proper use and maintenance of VADs.

[0004] Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and incorporated into the Infusion Nurse Standards (INS) guidelines.

[0005] In developed markets, needleless connectors are typically used when utilizing IV catheters to close the system and then access the catheter to administer medications or other necessary fluids to the patient. The INS Standards of Practice recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access." Disinfection of needleless connectors ultimately aims to help reduce bacteria that may inhabit surfaces and cause various catheter-related complications, including CRBSI. Nurses typically complete the disinfection process using a 70% isopropyl alcohol (IPA) pad, a process known as "hub scrubbing." However, compliance and the level of disinfection resulting from this practice typically depend on the ability and competency of the user. In addition to a lack of adherence to "hub scrubbing," interviews with clinicians have also noted frequent variability in scrubbing time, drying time, and frequency of needleless connector scrubbing.

[0006] Threaded needleless connectors are used to reduce CRBSI cases and ensure VADs are used and maintained properly because threaded connectors are safer than slip connectors. However, while threaded needleless connectors, such as threaded Luer connectors, are safer, they require more manipulation by the clinician and connection is not as fast as a Luer slip connector.

[0007] Therefore, there is a need for a medical connector that can disinfect the luer connector and prevent reuse, thereby reducing the risk of disinfectants entering the bloodstream. Additionally, there is a need for a device that mates with a medical connector that provides the security of a threaded connector but the ease of use of a slip connector. Summary of the Invention

[0008] One aspect of the present disclosure relates to a medical connector and mating element (i.e., a needleless 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 radial protrusion extending from the cylindrical housing body and a cavity defined by a closed end, an open end, a partially cylindrical inner wall of the housing body, and a radial sidewall of the radial protrusion. In some embodiments, the closed end further includes a lumen for transferring fluid beyond the closed end. The locking structure is disposed on a lateral portion of the radial sidewall of the cavity, and the locking structure includes an angled tab. An insert is advanced into the housing cavity, the insert including a disk-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 the inner wall of the locking tab and a recessed notch disposed in a distal portion of the outer wall of the locking tab.

[0009] In one or more embodiments, the insert rotates from a first position to a locked position, the first position being defined by a medial portion of the radial sidewall and the locked position being defined by a side portion, the side portion including a locking structure. In one or more embodiments, the recessed notch engages a protrusion of the ramped tab when the recessed notch is advanced over the ramped tab. In one or more embodiments, the locking tab is elastically deformable.

[0010] In one or more embodiments, the locking structure further includes an outwardly facing ramp that slopes outward from an inward or leftward position to a sideways or rightward position.

[0011] In one or more embodiments, the outwardly sloping surface extends for at least a portion of the arc length of the radial sidewall. In one or more embodiments, the outwardly sloping surface extends for the entire arc length of the radial sidewall.

[0012] In one or more embodiments, the angled tab extends from a side portion of the outwardly angled surface. In one or more embodiments, the outwardly angled surface causes deformation of the locking tab.

[0013] In one or more embodiments, the locking structure further includes a proximal ramp that is disposed adjacent the ledge of the ramp.

[0014] In one or more embodiments, the proximal sloped surface slopes inward relative to the radial sidewall from a distal position to a proximal position.

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

[0016] In one or more embodiments, the medical connector further comprises an absorbent material disposed between the distal surface of the insert and the inner upper surface of the cavity of the housing when the insert is fully advanced into the cavity. In one or more embodiments, the absorbent material contains an antiseptic.

[0017] In one or more embodiments, by advancing the insert fully distally into the cavity, the distal surface of the insert and the upper inner surface of the housing cavity compress the absorbent material, which releases the antiseptic into the cavity through a gap defined by the partial cylindrical inner wall of the housing and the side wall of the insert.

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

[0019] In one or more embodiments, the retention tab is disposed on the inner upper surface of the housing, which non-removably secures an opening disposed on the distal surface of the insert, the opening extending therethrough.

[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 radial protrusion extending from the cylindrical housing body and a cavity defined by a closed end, an open end, a partially cylindrical inner wall of the housing body, and a radial sidewall of the radial protrusion. The locking structure is disposed on a side portion of the radial sidewall of the cavity, and the locking structure includes an angled tab. An insert is advanceable within the housing cavity, the insert including a disk-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 on the inner wall of the locking tab and a recessed notch disposed in a distal portion of the outer wall of the locking tab. When a corresponding medical connector is threaded into the cavity, the insert advances into the cavity, and the corresponding medical connector has at least one thread for engaging the at least one thread of the insert.

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

[0022] A third aspect of the present disclosure relates to a medical connector for a syringe having a housing protruding distally from a distal wall of the syringe barrel, the housing including a cavity defined by the distal wall of the syringe barrel, an open end opposite the distal wall, and a partial cylindrical sidewall extending from the distal wall to the open end, the housing further including a radial sidewall defined by a radial protrusion extending laterally from the housing, the radial protrusion and the radial sidewall being in the shape of a laterally protruding arc.

[0023] The syringe further includes a tapered hub disposed within the cavity of the housing, the tapered hub extending distally from the distal wall of the syringe barrel, the tapered hub configured to intersect with a corresponding cavity in the housing of the vascular access device.

[0024] The syringe further comprises a locking structure disposed on the radial sidewall including an outwardly sloping surface and an inclined tab, the inclined surface inclining outward from an inward or leftward position to a lateral or rightward position, the outwardly sloping surface extending at least partially the arc length of the radial sidewall, the inclined tab inclining outward from the lateral or rightward position to the inward or leftward position, and the inclined tab including a ledge formed by the wall at a substantially right angle to the radial sidewall.

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

[0026] The first position is defined by an inward or leftward portion of the radial sidewall, and the locked position is defined by an angled tab and protrusion. The housing is configured as a medical connector capable of accepting a male Luer fitting of a vascular access device. When the insert is advanced proximally into the housing cavity, the locking tab is positioned in the first position, elastically deforming the locking tab insert outward relative to the radial sidewall. As the insert rotatably approaches the locked position, the outwardly angled surface elastically deforms the locking tab inward until the recessed notch clears the protrusion of the radial sidewall, thereby preventing inward or leftward movement of the locking tab when the notch passes the protrusion and non-releasably engages the protrusion.

[0027] A third embodiment of the present disclosure relates to a medical connector including 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 disposed on the inner sidewall of the cavity. A channel is disposed on the inner sidewall having a substantially rectangular profile extending from the distal wall to the open end. An absorbent material abuts the inner distal surface of the housing.

[0028] The medical connector further includes a leaf spring disposed within the channel, the leaf spring having a rectangular cross section and an arc, the arc being between a distal portion and a proximal portion, the distal portion being permanently attached to the channel and the proximal portion contacting the channel in an initial state.

[0029] When the corresponding medical connector is advanced into the cavity, the at least one thread of the corresponding medical connector presses the arc of the spring down into the channel, causing a defect in the proximal portion of the spring away from the channel that defines the final state, and a proximal end of the proximal portion of the spring engages with a lower segment of the at least one thread of the corresponding medical connector, thereby locking the corresponding medical connector in the cavity with a threaded and interference fit.

[0030] A fourth embodiment of the present disclosure relates to a medical connector comprising a substantially cylindrical housing having a cavity defined by a distal wall, a proximal open end, an inner distal surface, and the proximal open end and the closed distal end. The medical connector comprises a frustoconical disc body extending from the proximal end of the disc body, at least two prongs extending proximally from the proximal end of the disc body, each of the at least two prongs having a proximal portion and a distal portion adjacent the proximal portion, the distal portions forming an inner hook extending toward a center of the disc body, the inner hook including an inner hook configured to engage with a corresponding thread of a corresponding medical connector. The medical connector further comprises an absorbent material abutting the inner distal surface of the housing.

[0031] Advancement of the corresponding medical connector into the cavity deforms the disc body inward, forcing the proximal end of the disc body against the lower segment of at least one thread of the corresponding medical connector, thereby locking the corresponding medical connector within the cavity.

[0032] A fifth embodiment of the present disclosure relates to a medical connector including 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 disposed on the inner sidewall of the cavity, the helical thread having a distal portion integrally formed on the inner sidewall and a frangible portion at the distal portion configured to approximate the removal and cross threads upon threading and advancement of a corresponding thread of a corresponding medical connector into the cavity. An absorbable material abuts the inner distal surface of the housing.

[0033] A sixth embodiment of the present disclosure relates to a medical connector comprising a substantially cylindrical housing having a distal wall, a proximal open end, a sidewall extending between the distal wall and to the open end, a cavity extending from the open end to the distal wall, an inner distal surface, and at least one tooth extending inwardly from the inner sidewall of the housing into the cavity, the at least one tooth being disposed 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, the disc-shaped body having a proximal surface and a distal surface, at least two locking tabs extending distally from and away from the distal surface, each of the at least two locking tabs having a hooked proximal end configured to interlock with corresponding threads of a corresponding medical connector, a plurality of ridges disposed on a sidewall of the disc-shaped body, the plurality of ridges configured to mate with at least one tooth of the housing, and an absorbent material abutting an inner distal surface of the distal wall of the housing.

[0035] A seventh aspect of the present disclosure relates to a medical connector comprising 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 comprises 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 living hinges extending from the distal end. An absorbent material abuts the inner distal surface of the distal wall of the housing.

[0036] Advancement of a corresponding medical connector into the cavity causes deflection of the c-shaped body, thereby locking the open proximal end against the threads of the corresponding medical connector.

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

[0038] The medical connector further includes an insert in the form of a C-shaped body having an arc-shaped distal portion, an open proximal portion, and at least two living hinges extending adjacent to the distal portion. The absorbent material is adjacent to the inner distal surface of the distal wall of the housing. Advancement of a corresponding medical connector into the cavity causes deflection of the insert, thereby locking the open proximal end against the threads of the medical connector. The inner wall further includes an opening configured to receive the distal portion of the insert. [Brief explanation of the drawings]

[0039] [Figure 1A] FIG. 1A illustrates a perspective view of a housing of a medical connector assembly according to a first exemplary embodiment of the present disclosure. [Figure 1B] FIG. 1B shows a perspective side view of a housing body of a medical connector according to the embodiment as shown in FIG. [Figure 2A] 2A shows a perspective view of an insertion bottom view of a medical connector according to the embodiment as shown in FIG. 1. FIG. [Figure 2B] 2B shows a perspective view of an insertion bottom view of a medical connector according to the embodiment as shown in FIG. 1. FIG. [Figure 3] FIG. 3 shows a perspective bottom view of the housing body of the medical connector according to the embodiment as shown in FIG. [Figure 4] FIG. 4 illustrates a perspective side view of the housing body and insert of the medical connector according to the embodiment shown in FIG. [Figure 5] FIG. 5 shows a perspective bottom view of the housing body of the medical connector according to the embodiment as shown in FIG. [Figure 6] FIG. 6 illustrates a perspective bottom view of the housing body and insert of the medical connector according to the embodiment shown in FIG. [Figure 7] FIG. 7 illustrates a bottom view of the housing body and insert of the medical connector according to the embodiment shown in FIG. [Figure 8] FIG. 8 illustrates a bottom view of the housing body and insert of the medical connector according to the embodiment shown in FIG. [Figure 9] 9 illustrates a cross-sectional side view of a housing body and insert of a medical connector according to the embodiment shown in FIG. [Figure 10] FIG. 10 shows the elastic deformation of the locking tab in the first position and in the locked position. [Figure 11] FIG. 11 shows a cross-sectional view of the medical connector inserted into the housing body and the insert of the medical connector. [Figure 12] FIG. 12 shows a side perspective view of the medical connector inserted into the housing body and the insert of the medical connector. [Figure 13A] FIG. 13A shows a perspective view of a housing of a syringe according to a second embodiment of the present disclosure. [Figure 13B] FIG. 13B shows a top view of the housing of the syringe according to the second embodiment as shown in FIG. 13A. [Figure 13C]FIG. 13C shows a perspective side view of the housing of the syringe according to the second embodiment as shown in FIG. 13A. [Figure 13D] FIG. 13D shows a perspective side view of the housing of the syringe according to the second embodiment as shown in FIG. 13A. [Figure 14A] FIG. 14A shows a perspective side view of an insert according to the second embodiment, as shown in FIG. 13A. [Figure 14B] FIG. 14B shows a perspective side view of the insert according to the second embodiment, as shown in FIG. 13A. [Figure 15] FIG. 15 shows a perspective side view of the insert inserted into the housing of the syringe according to the second embodiment, as shown in FIG. 13A. [Figure 16] FIG. 16 shows a cross-sectional view of the insert inserted into the housing of the syringe according to the second embodiment, as shown in FIG. 13A. [Figure 17] FIG. 17 shows a perspective view of a housing of a medical connector according to a third embodiment of the present disclosure. [Figure 18A] FIG. 18A shows a cross-sectional view of the housing in an initial state according to the third embodiment as shown in FIG. [Figure 18B] FIG. 18B shows a cross-sectional view of the housing in an initial state according to the third embodiment as shown in FIG. [Figure 19] FIG. 19 shows a perspective view of the housing in the final state according to the third embodiment as shown in FIG. [Figure 20] FIG. 20 shows a cross-sectional view of the housing in the final state according to the third embodiment as shown in FIG. [Figure 21A] FIG. 21A illustrates a cross-sectional view of a housing in an initial state according to a fourth embodiment of the present disclosure. [Figure 21B] FIG. 21B shows a cross-sectional view of the housing in the initial state according to the fourth embodiment as shown in FIG. 21A. [Figure 22A] FIG. 22A shows a cross-sectional view of the housing in the final state according to the fourth embodiment as shown in FIG. 21A. [Figure 22B] FIG. 22B shows a cross-sectional view of the housing in an initial state according to the fourth embodiment as shown in FIG. 21A. [Figure 22C] FIG. 22C shows a cross-sectional view of the housing according to the fourth embodiment shown in FIG. 21A in the final state. [Figure 23A] FIG. 23A shows a perspective side view of a housing in an initial state according to a fifth embodiment of the present disclosure. [Figure 23B] FIG. 23B shows a cross-sectional view of the housing in an initial state according to the fifth embodiment as shown in FIG. 23A. [Figure 24A] FIG. 24A shows a perspective view of the housing in the final state according to the fifth embodiment as shown in FIG. 23A. [Figure 24B] FIG. 24B shows a cross-sectional view of the housing in the final state according to the fifth embodiment as shown in FIG. 23A. [Figure 25A] FIG. 25A shows a perspective view of an insert according to a sixth embodiment of the present disclosure. [Figure 25B] FIG. 25B shows a perspective view of an insert according to a sixth embodiment of the present disclosure. [Figure 26] FIG. 26 illustrates a cross-sectional view of the insert of FIGS. 25A and 25B disposed within a housing of an exemplary medical connector according to a sixth embodiment of the present disclosure. [Figure 27] FIG. 27 illustrates 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. [Figure 28A] FIG. 28A 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. [Figure 28B] FIG. 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 OF THE INVENTION

[0040] Embodiments of the present disclosure relate to sterile medical connectors for connection to and disinfection of corresponding medical connectors having open lumens, including male and female needleless connectors, luer connectors, and stopcocks. In some embodiments, the medical connector can have a male or female luer connector. In some embodiments, the medical connector can be a syringe cap or connector. 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, where the insert and absorbent material are disposed within the housing. Upon insertion of the corresponding medical connector into the housing, the corresponding medical connector is advanced relative to the housing and insert, compressing the absorbent material, thereby releasing an antibacterial disinfectant liquid or gel (hereinafter "disinfectant"), which, in some embodiments, prevents reuse of the medical connector and the corresponding medical connector. The disinfectant disinfects the corresponding medical connector. In one or more embodiments, the medical connectors and corresponding medical connectors described in detail below have a single use means, whereby the insert of the medical connector is non-releasably locked to the housing of the medical connector.

[0041] The housing comprises a substantially cylindrical body having a radial protrusion, a closed end, an open end, a cavity defined by a partial cylindrical inner wall of the housing, and a radial sidewall of the radial protrusion. The inner sidewall of the housing has a length L extending from the closed end to the distal wall. C In one or more embodiments, the open end includes an engagement surface having a peelable seal attached thereto.

[0042] 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 with a female luer connector. The cap provides a mechanical barrier for the connector and contains an antimicrobial agent for disinfection. The medical connector of the present disclosure also streamlines the disinfection process while blocking the open luer lumen, facilitating mitigation of ingress of contaminants and disinfectants into the open lumen of the connector, thereby reducing the risk of contaminants and disinfectants entering the bloodstream.

[0043] The following definitions are provided for terms used in this disclosure.

[0044] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0045] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line.

[0046] As used herein, the terms "medical connector" and "corresponding medical connector" refer to needleless and needle-free medical connectors, such as BD MAXPLUS, BD MAXZERO®, STARTSITE®, NEUTRACLEAR®, BD Q-SYTE®, Becton Dicenson, and COMPAN®. Additionally, the terms "medical connector" and "corresponding medical connector" refer to sterile connectors with male or female open lumens, luer connectors, and stopcocks. The terms "medical connector" and "corresponding medical connector" also refer to mating elements of needleless and needleless connectors, which may be incorporated into medical devices that connect to the medical connector, such as syringe caps or connectors. A medical connector can include an element that connects or mates with a corresponding medical connector, e.g., a male medical connector having an element that mates with a corresponding female medical connector.

[0047] As used herein, the terms "needleless connector" and "corresponding needleless connector" refer to a combination of male and female connectors. If the needleless connector is a male needleless connector, the corresponding needleless connector is a female needleless connector. Similarly, if the needleless connector is a female needleless connector, the corresponding needleless connector is a male needleless connector. The needleless connector may be a cap, a connector for a syringe, a connector for a vascular access device, a connector for 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 regular open luer connector.

[0048] As used herein, the term "Luer connector" refers to a connecting tube that is a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing that is slightly tapered to allow a secure connection with a simple press / twist fit. Luer connectors can optionally include an outer threaded rim for added security. The male end of a Luer connector is typically associated with a flush syringe and can interlock and connect to a female end located on a vascular access device (VAD). Luer connectors also have a distal channel that removably attaches to the hub of a VAD and a proximal channel that removably attaches to the barrel of a syringe.

[0049] As used herein, ISO 80369-7:2016 defines specifications for standard Luer connectors, including a 6% taper between the distal and proximal ends. Male standard Luer connectors increase in taper from the open distal end to the proximal end. Female standard Luer connectors decrease in taper from the open proximal end to the distal end. According to ISO 80369-7:2016, male standard Luer connectors have an outer diameter of 3.970 mm to 4.072 mm, measured 0.75 mm from the distal end of the tip. The length of the male standard Luer taper is 7.500 mm to 10.500 mm. The outer cross-sectional diameter, measured 7.500 mm from the distal end of the tip, is 4.376 mm to 4.476 mm. As used herein, the phrases "male standard luer connector" and "female standard luer connector" shall refer to connectors having dimensions set forth in ISO 80369-7, the entirety of which is incorporated herein by reference.

[0050] As will be readily understood by one of ordinary skill in the relevant art, terms such as "lock," "tip," "hub," "screw," "sponge," "prong," "protrusion / insert," "tab," "slope," "wall," "top," "side," "bottom," and other descriptive terms are used herein for ease of understanding, but are not intended to limit the components that may be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0051] The matters exemplified in this description are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and structures are omitted for the sake of clarity and conciseness.

[0052] In one or more exemplary embodiments of the present disclosure, the medical connector is in the form of a cap having mating elements, such as 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 antiseptic cap includes at least one thread and other features, in any and all combinations, that allow it to interface with corresponding threads or threads of a plurality of female-threaded fittings.

[0053] According to a further exemplary implementation of an embodiment of the present disclosure, the configuration of the structural elements that make up the insert includes a tab protruding from the insert, the tab including at least one thread for connecting to a corresponding thread or threads of a corresponding medical connector.

[0054] According to yet another exemplary implementation of an embodiment of the present disclosure, the female threads are of a size and thread pattern that mates with a standard ISO 594-2 type male fitting and / or the male threads are of a size and thread pattern that mates with a standard ISO 594-2 type female fitting. An example of an ISO 594-2 type fitting is a Q-style fitting.

[0055] According to still further exemplary implementations of embodiments of the present disclosure, the tabs of the insert may bend or resiliently deform to allow for a better interference fit with the fitting.

[0056] In one or more embodiments, the female luer connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0057] In one or more embodiments, the male medical connector can be an intravenous tubing end or a stopcock. In some embodiments, the described medical connectors are configured to receive a slip connector, such as a Luer slip connector. In some embodiments, the described medical connectors include one or more engaging elements, such as teeth or c-clips, configured to engage the threaded connector and slip connector by advancing the threaded connector or slip connector into the medical connector. In some embodiments, the described medical connectors can engage a threaded connector, such as a threaded Luer connector, simply by advancing the threaded connector into the medical connector, without the need for the clinician to thread, rotate, or torque the threaded connector or its mating elements.

[0058] In some embodiments, the tooth or c-clip further comprises a set of tabs protruding from the distal end of the tooth or c-clip. In the fully advanced position, one of the set of tabs interlocks with the threads of the corresponding medical connector. The set of tabs engages with the threads of the needleless connector to irremovably lock the corresponding medical connector. In some embodiments, the set of tabs is wider than the 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.

[0059] In some embodiments, the medical connectors of the embodiments described herein are configured to produce an audible click or sound that is detectable by either a clinician or an auxiliary detection system when the corresponding threaded medical connector is fully advanced.

[0060] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0061] Referring now to the drawings, in which like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows.

[0062] A first aspect of the present disclosure relates to a housing 110 of a medical connector 100. As shown in FIGS. 1A and 1B , the medical connector is in the form of a cap. In some embodiments, the housing 110 is an element that connects or mates with a corresponding medical connector. The housing 110 of the medical connector 100 has a partial cylindrical shape integrated with a radial protrusion 180, which is in the form of a protruding arc. The angle of the protruding 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 partial cylindrical inner wall 120. The partial cylindrical inner wall 120 is integrated with a radial sidewall 182. The radial sidewall 182 of the housing 110 includes a locking structure, which will be described in more detail below.

[0063] The closed end 112 is distally located and the open end 114 is proximally located relative to the closed end 112. In one or more embodiments, the partially cylindrical inner wall 120 has a substantially constant diameter D IS In one or more embodiments, the partially cylindrical inner wall 120 may further taper outward, the taper increasing proximally toward the open end 114. A corresponding medical connector is received in the cavity 130 through the open end 114.

[0064] The housing 110 further includes an outer sidewall 116. The outer sidewall 116 in the depicted embodiment has a partial cylindrical shape with 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 multiple axial ribs. In one or more embodiments, the outer sidewall 116 may have multiple radial ribs. In one or more embodiments, the outer sidewall 116 may have a gripping surface to facilitate manipulation by the practitioner. The gripping surface may be textured or may have a coating.

[0065] A second aspect of the present disclosure relates to an insert 150 disposed within the housing 110. As shown in FIGS. 2A and 2B , the insert 150 has a generally disc-shaped body 152 having a distal surface 154, a proximal surface 156, and a sidewall 158. Extending from the sidewall 158 is a locking tab 160 that extends from the proximal surface 156 of the disc-shaped body 152 in a proximal direction away from the proximal surface 156. In one or more embodiments, the disc-shaped body 152 includes an aperture 153 disposed on the distal surface 154 of the disc-shaped body 152 and extending therethrough. The center of the aperture 153 is concentric with the center of the disc-shaped body 152. The disk-shaped body 152 has a diameter DDB that is smaller than the diameter DIS of the partial cylindrical inner wall 120 and defines a gap between the side wall 158 and the partial cylindrical inner wall 120 of the housing 110.

[0066] In one or more embodiments, the locking tab 160 is a cantilevered prong having a distal portion 162 and a proximal portion 164. In one or more embodiments, the distal portion 162 is integral with the sidewall 158 of the disc-shaped body 152. In one or more, the distal portion 162 and the sidewall 158 of the disc-shaped body 152 may be joined together via 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 disc-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 disc-shaped body 152. In one or more embodiments, the locking tab 160, the distal portion 162, and the proximal portion, in combination or individually, bend or elastically deform. In an exemplary implementation, at least a portion of the locking tab 160 elastically deforms inward to create an interference fit between the locking tab 160 and a corresponding medical connector.

[0067] The proximal portion 164 of the locking tab 160 further comprises 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 the proximal end of the proximal portion 164 and extends distally at least partially the length of the proximal portion 164. In one or more embodiments, the recessed notch 170 is adjacent a lateral or right edge of the outer wall 166 relative to the outer wall 166. In one or more embodiments, the recessed notch 170 is adjacent an inner or left edge of the outer wall 166 relative to the outer wall 166.

[0068] In one or more embodiments, when a corresponding medical connector is advanced distally into the housing 110 by threading the corresponding medical connector in a rightward or lateral direction in accordance with the ISO 80369-7:2016 standard, the recessed notch 170 is disposed on a lateral or right edge of the outer wall 166 relative to the outer wall 166. In one or more embodiments, when a corresponding medical connector is advanced distally into the housing 110 by threading the corresponding medical connector in a leftward angular direction, the recessed notch 170 is disposed on an inner or left edge of the outer wall 166 relative to the outer wall 166. The depicted embodiment of FIGS. 2A and 2B shows the recessed notch 170 disposed on a lateral or 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 semicircular, semi-oval, triangular, or any other geometric shape.

[0069] At least one thread 172 is disposed on the inner wall 168 of the locking tab 160. In a preferred embodiment, the at least one thread 172 has a helical shape. The helical shape is essentially tapered from one direction to the other. In one or more embodiments, the taper decreases from a right or lateral direction to a medial or left direction relative to the outer wall 166.

[0070] In one or more embodiments, when a corresponding medical connector is advanced distally into the housing 110 by threading the corresponding medical connector in a clockwise, rightward, or lateral direction in accordance with the ISO 80369-7:2016 standard, the taper decreases from a leftward or medial direction relative to the outer wall 166. In one or more embodiments, when a corresponding medical connector is advanced distally into the housing 110 by threading the corresponding medical connector in a counterclockwise or leftward angular direction, the taper decreases from a rightward or lateral direction relative to the outer wall 166. The depicted embodiment of Figures 2A and 2B shows a taper that decreases from a leftward or medial direction relative to the outer wall 166. In one or more embodiments, the corresponding medical connector is first advanced partially distally into housing 110 until the luer tip of the corresponding medical connector abuts proximal surface 154 of disc-shaped body 152. In one or more embodiments, the corresponding medical connector is first advanced partially distally into housing 110 until the threads of the corresponding medical connector abut at least one thread 172. In one or more embodiments, advancement of the corresponding medical connector into housing 110 causes advancement of disc-shaped body 152 into housing body 110. The corresponding medical connector can then be rotated, which causes locking and final advancement of disc-shaped body 152 into housing 110.

[0071] A third aspect of the present disclosure relates to a locking structure disposed within the cavity 130 of the housing 110, as shown in FIG. 3 , where the locking structure is disposed on or has an integrated feature in the radial sidewall 182 of the housing 110. The locking structure includes an outwardly angled surface 184 that slopes outward from an inward or leftward position to a sideways or rightward position. In the depicted embodiment, the outwardly angled surface 184 extends at least partially the length of the arc of the radial sidewall 182. In one or more embodiments, the outwardly angled surface 184 extends the entire length of the arc of the radial sidewall 182. Extending from a lateral portion of the outwardly angled surface 184 is an angled tab 186. The angled tab 186 slopes outward from a sideways or rightward position to an inward or leftward position. The angled tab 186 includes a ledge 188 formed by the wall at a substantially right angle to the radial sidewall 182. In one or more embodiments, adjacent to ledge 188 is a proximal sloped surface 190 that slopes inwardly relative to radial sidewall 182 from a distal position to a proximal position.

[0072] As shown in FIG. 3 , the inward or left-facing portion of radial sidewall 182 is substantially smooth without protrusions or depressions, and the lateral or right-facing portion of radial sidewall 182 includes an outwardly facing angled surface 184, an angled tab 186, a ledge 188, and a proximal angled surface 190. As used herein, first position 192 is defined by the inward or left-facing portion of radial sidewall 182, and locked position 194 is defined by angled tab 186 and ledge 188. As shown in FIG. 4 , when insert 150 is advanced distally into cavity 130 of housing 110, locking tab 160 is disposed in first position 192. In one or more embodiments, advancement of insert 150 into cavity 130 causes the locking tab to resiliently deform outward relative to radial sidewall 182. Once insert 150 is fully advanced into cavity 130, insert 150 is free to rotate along the arc of radial sidewall 182. As insert 150 approaches locked position 194, outwardly angled surface 184 further resiliently deforms locking tab 160 until recessed notch 170 clears ledge 188 in radial sidewall 182. When notch 170 clears ledge 188, the notch non-releasably engages ledge 188, thereby preventing inward or leftward movement of locking tab 160.

[0073] In some embodiments, when the notch 170 passes the ledge 188, an audible click or sound is produced that is detectable by the clinician or an auxiliary detection system, indicating that the insert 150, and therefore the needleless connector, has reached a fully locked position.

[0074] Figures 5 and 6 show perspective views of the insert 150 in the first position 192 and the locked position 194, respectively. Similarly, Figures 7 and 8 show top views of the insert 150 in the first position 192 and the locked position 194, respectively. As shown in Figures 7 and 8, the thickness of the radial sidewall 182 gradually increases from a value T1 to a value T2 due to the outwardly sloping surface 184.

[0075] FIG. 9 shows a partial cross-sectional view of cavity 130 with insert 150 fully advanced into cavity 130 and in first position 192. For illustrative purposes, distal surface 154 of disk-shaped body 152 is directly adjacent to inner top surface 122 of housing 110; however, in one or more embodiments, antiseptic-containing absorbent material 199 is disposed between distal surface 154 of disk-shaped body 152 and inner top surface 122 of housing 110. Advancement of a corresponding medical connector 150 into cavity 130 compresses absorbent material 199, thereby releasing the antiseptic. In one or more embodiments, closed end 112 includes a concentric retention tab 124 that mechanically locks onto opening 153 of disk-shaped body 152, thereby preventing removal of insert 150. In one or more embodiments, the concentric retention tab includes a distal cylindrical shape and a proximal cylindrical shape, the proximal cylindrical shape having a larger diameter than the distal cylindrical shape. In one or more embodiments, the diameter of the proximal cylindrical shape is larger than the diameter of the opening 153 in the disk-shaped body 152, forming a snap-fit ​​connection between the retention tab 124 and the opening 153 in the disk-shaped body 152. In one or more embodiments, the retention tab 124 is long enough to allow a cylindrical absorbent material disc to be placed between the disk-shaped body 152 and the inner top surface 122 of the housing 110, the cylindrical absorbent material disc having an opening extending therethrough. The overall length of the retention tab 124 is equal to or slightly greater than the thickness of the disk-shaped body 152 and the thickness of the cylindrical absorbent material disc, thereby allowing the cylindrical absorbent material disc to be in an uncompressed state. Insertion of the connector compresses the cylindrical absorbent material disc, thereby releasing the antiseptic into the cavity 130.

[0076] The corresponding medical connector is a female needleless connector 80, as shown in FIGS.

[0077] 11 , in one or more embodiments, an absorbent material 199 is disposed within the cavity 130, with the absorbent material 199 adjacent the proximal surface 156 of the disk-shaped body 152. Insertion of the female needleless connector 80 compresses the absorbent material 199, thereby releasing the antiseptic into the cavity 130. The at least one thread 82 of the connector 80 engages with the at least one thread 172 of the insert 150. The at least one thread 82 is disposed on the hub 84 of the female needleless connector 80.

[0078] As shown in FIG. 12 , during operation, the female connector 80, having at least one thread 82, engages with at least one thread 172 of the insert 150, thereby advancing the female connector 80 and insert 150 into the housing 110. When the locking tab 160 is non-releasably locked in the second position and the absorbent material 199 (not shown for clarity) is compressed, the disinfectant is released into the cavity 130. In embodiments in which the absorbent material 199 is positioned against the closed distal end 112 of the housing 100, the released disinfectant drains through the gap 123 created between the disk-shaped body 152 and the partially cylindrical inner wall 120. After disinfection is completed, the female connector 80 is not threaded in the opposite direction, allowing the female connector 80 to be released while the ledge 188 engaging the recessed notch 170 prevents removal of the insert 150. FIG. 10 illustrates the elastic deformation of the locking tab 160 in the first position 192 and the locked position 194, respectively. The deformation more securely engages the at least one thread 172 with the at least one thread of the female connector 80. For purposes of illustration, 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 illustrated relative to line AA, where the locking tab 160 is deformed inward.

[0079] A second embodiment of the present disclosure relates to a housing 210 of a syringe 200. As shown in FIGS. 13A-13D, the housing 210 protrudes distally from a distal wall 212 of a syringe barrel 213 of the syringe 200. As shown in FIG. 13A, the housing 210 of the second embodiment is configured as a needleless connector capable of receiving a male luer fitting commonly associated with a VAD. The housing 210 includes a cavity 230 defined by the distal wall 212 of the syringe barrel 213, an open end 214 opposite the distal wall 212, and a partially cylindrical sidewall 216 extending from the distal wall 212 to the open end 214. A tapered hub 232 is disposed within the cavity 230, and the tapered hub 232 extends distally from the distal wall 212 of the syringe barrel 213. The tapered hub 232 is configured to intersect with a corresponding cavity in the housing of a VAD (not shown). In some embodiments, the tapered hub 232 is configured to create a fluid-tight seal with the housing of the VAD. In some embodiments, the tapered hub 232 is configured to create an interference fit with the housing of the VAD.

[0080] The housing 210 and the partial cylindrical sidewall 216 are partially cylindrical in shape, with the partial cylindrical sidewall 216 having an integral radial protrusion 280 extending laterally from the housing 210. The radial protrusion 280 defines a radial sidewall 282, which includes a locking structure, described in more detail below. The radial protrusion 280 and the radial sidewall 282 are in the shape of a laterally protruding arc. The angle of the protruding arc ranges from 10 degrees to 350 degrees.

[0081] In one or more embodiments, the partially cylindrical inner wall 216 has a substantially constant diameter. In one or more embodiments, the partially cylindrical inner wall 216 can include an outward taper, which increases distally toward the open end 214.

[0082] Housing 210 further includes an outer sidewall 216. Outer sidewall 216 in the depicted embodiment has a partial cylindrical shape including a smooth surface and a chamfer 218. In one or more embodiments, chamfer 218 may be rounded. In one or more embodiments, chamfer 218 may extend partially around the distal end of outer sidewall 216.

[0083] As best shown in FIGS. 13B-13D , the locking structure is disposed within cavity 230 of housing 210, and the locking structure has features that are integral with radial sidewall 282 of housing 210. The locking structure includes an outwardly angled surface 284 that angles outward from an inward or leftward position to a sideways or rightward position. In the depicted embodiment, outwardly angled surface 284 extends at least partially the length of the arc of radial sidewall 282. In one or more embodiments, outwardly angled surface 284 extends the entire length of the arc of radial sidewall 282. An angled tab 286 extends from a side portion of outwardly angled surface 284. The angled tab 286 angles outward from a sideways or rightward position to an inward or leftward position. The angled tab 286 includes a ledge 288 formed by the wall at a substantially right angle relative to radial sidewall 282. In one or more embodiments, adjacent to ledge 288 is a proximal sloped surface 290 that slopes inwardly relative to radial sidewall 282 from a distal position to a proximal position.

[0084] 13C and 13D , an inner or left-hand portion of radial sidewall 282 is substantially smooth without protrusions or depressions, and a lateral or right-hand portion of radial sidewall 282 includes an outwardly facing angled surface 284, an angled tab 286, a ledge 288, and a proximal angled surface 290. As used herein, first position 292 is defined by the inner or left-hand portion of radial sidewall 282, and locked position 294 is defined by angled tab 286 and ledge 288.

[0085] 14A and 14B, the insert 250 has a generally 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 distally from and away from the distal surface 256 of the disc-shaped body 252. In one or more embodiments, the disc-shaped body 252 includes an opening 253 disposed on the proximal surface 254 of the disc-shaped body 252 and extending therethrough. The center of the opening 253 is concentric with the center of the disc-shaped body 252. The disc-shaped body 252 has a diameter D DB and has a diameter D DB is the diameter D of the partially cylindrical inner wall 220 IS and defines a gap between the side wall 258 and the partially cylindrical inner wall 220 of the housing 210.

[0086] In one or more embodiments, the locking tab 260 is configured as a cantilevered prong 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, the proximal portion 262 and the sidewall 258 of the disc-shaped body 252 may be joined together via 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, in combination or individually, bend or elastically deform. In the exemplary embodiment, at least a portion of locking tab 260 resiliently deforms inward to create an interference fit between locking tab 260 and a corresponding medical connector.

[0087] The proximal portion 264 of the locking tab 260 further comprises 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 the distal end of the distal portion 264 and extends proximally at least partially along the length of the distal portion 264. In one or more embodiments, the recessed notch 270 is adjacent a 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 an inner or left edge of the outer wall 266 relative to the outer wall 266.

[0088] In one or more embodiments in which the VAD is advanced proximally within the housing 210 by threading the VAD in a leftward angular direction in accordance with the ISO 80369-7:2016 standard, as shown in FIGS. 15 and 16 , the recessed notch 270 is located on the inner or left edge of the outer wall 266 relative to the outer wall 266. In one or more embodiments in which the VAD is advanced distally within the housing 210 by threading the VAD in a rightward angular direction, the recessed notch 270 is located on the inner or left edge of the outer wall 266 relative to the outer wall 266. Referring to the depicted embodiment of FIGS. 14A and 14B , the recessed notch 270 is shown positioned 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 semicircular, semi-elliptical, triangular, or any other geometric shape.

[0089] At least one thread 272 is disposed on the inner wall 268 of the locking tab 260. In a preferred embodiment, the at least one thread 272 has a helical shape. The helical shape is essentially tapered from one direction to the other. In one or more embodiments, the taper decreases from a right or lateral direction to a medial or left direction relative to the outer wall 266.

[0090] In one or more embodiments, when the VAD is advanced distally into the housing 210 by threading the VAD in a clockwise, rightward, or sideward angular direction, per 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 threading the VAD connector in a counterclockwise or leftward direction, the taper decreases from a rightward or medial direction relative to the outer wall 266. The depicted embodiment of FIGS. 14A and 14B shows a taper that decreases from a leftward or medial direction relative to the outer wall 266.

[0091] As described above with respect to the first embodiment and shown in FIGS. 15 and 16 , when the insert 250 is advanced proximally into the cavity 230 of the housing 210, the locking tab 260 is disposed in a first position 292. In one or more embodiments, advancement of the insert 250 into the cavity 230 causes the locking tab 260 to resiliently deform outward relative to the radial sidewall 282. When the insert 250 is fully advanced into the cavity 230, the insert 250 is free to rotate along the arc of the radial sidewall 282. As the insert 250 rotates toward the locked position 294, the outwardly facing ramp 284 resiliently deforms the locking tab 260 inward until the recessed notch 270 clears the ledge 288 in the radial sidewall 282. When the notch clears the ledge 288, the notch non-releasably engages the ledge 288, thereby preventing inward or leftward movement of the locking tab 260.

[0092] In some embodiments, when the notch 270 passes the ledge 288, an audible click or sound is produced that is detectable by the clinician or an auxiliary detection system to indicate that the insert 250, and therefore the medical connector, has reached the fully locked position.

[0093] As best shown in FIG. 16 , the proximal face 254 of the insert 250 abuts the distal wall 212 of the syringe barrel 213 of the syringe 200 in the fully advanced position. In one or more embodiments, a circular protrusion 234 is disposed on the tapered hub 232. The circular protrusion 234 is configured to irremovably lock the insert 250 in the fully advanced position. The circular protrusion 234 is spaced from the distal wall 212 of the syringe barrel 213 by a distance that is configured to be equal to or slightly greater than the thickness of the disk-shaped body of the insert 250. In one or more embodiments, the circular protrusion 234 has a substantially triangular cross-section having a proximal right angled face relative to the tapered hub 232 and a distal acute angled face relative to the tapered hub 232. The distal sharp surface of circular protrusion 234 is configured to cause slight deformation of insert 250 when insert 250 contacts the distal sharp surface of circular protrusion 234 as insert 250 advances proximally. The proximal right surface of circular protrusion 234 is configured to irremovably secure insert 250 when insert 250 traverses completely over the triangular cross section of circular protrusion 234.

[0094] A third embodiment of the present disclosure relates to a housing 310 of a medical connector 300. Figures 17, 18A, and 18B illustrate the medical connector 300 in an initial, unactuated state, and Figures 19 and 20 illustrate the medical connector 300 in a final, actuated state with a corresponding medical connector (not shown) fully advanced into the cavity 330 of the housing 310.

[0095] As shown in FIGS. 17-18B , the medical connector 300 comprises a substantially cylindrical housing 310 having a distal wall 312, a proximal open end 314, a sidewall 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, an absorbent material 399 in the form of a disk is disposed within the cavity 330 and adjacent an inner distal surface 322 of the distal wall 312. An inner sidewall surface 318 of the sidewall 316 includes a channel 324 that extends from the distal wall 312 to the open end 314. On the inner sidewall surface 318, the channel 324 has a substantially rectangular profile, while the channel 324 extends deep into the sidewall 316. The depth of the channel 324 is configured to at least partially intersect with a spring 350, as described in further detail below.

[0096] The housing further includes a plurality of threads 320 disposed on the inner sidewall surface 318, but the plurality of threads 320 are not disposed on the channel 324. The plurality of threads 320 are configured to threadably mate with corresponding threads 82 of the female needleless connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12 ).

[0097] As shown in FIGS. 17-18B, and best shown in FIG. 18B, spring 350 is configured as a leaf spring having a rectangular cross-section and an arc 352. In one or more embodiments, arc 352 is pointed and forms a ramp. Arc 352 is between distal portion 354 and proximal portion 356. Distal portion 354 is permanently attached to channel 324, while proximal portion 356 is not attached to channel 324 and is free to deflect. In operation, proximal portion 356 initially abuts channel 324, as shown in FIGS. 17-18B. When needleless connector 80 is advanced into cavity 330, at least one thread 82 compresses arc 352 of spring 350 into channel 324. The recess in arc 352 biases proximal portion 354 of spring 350 outward, away from channel 324. 19 and 20 , the proximal end 355 of the proximal portion 354 of the spring 350 engages a lower segment of at least one thread 82 of the needleless connector 80, thereby locking the needleless connector 80 with a threaded fit and interference fit within the cavity 330. 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, utilizing a stronger spring.

[0098] 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 the housing 310 from being reused.

[0099] In some embodiments, when the needleless connector 80 is fully advanced into the cavity 330 and the spring 350 engages the corresponding threads 82, an audible click or sound is produced that can be detected by the clinician or an auxiliary detection system to indicate that the needleless connector 80 has been fully advanced into the cavity 330.

[0100] In some embodiments, the proximal end 355 of the spring 350 further comprises a set of tabs 353 protruding from the proximal end 355. In some embodiments, the set of tabs 353 are in the form of a C-clip. In the fully advanced position, the set of tabs 353 interlock with the threads of the corresponding needleless connector 80. The set of tabs 353 engage the threads of the needleless connector 80 to irremovably lock the corresponding needleless connector 80. In some embodiments, the set of tabs 353 are wider than the spring 350. In some embodiments, the set of tabs 353 are configured to disengage from the corresponding threads 82 and jump out of the thread path to prevent reuse.

[0101] A fourth embodiment of the present disclosure relates to a housing 410 of a medical connector 400. Figures 21A and 21B illustrate the medical connector 400 in an initial, unactuated state, and Figure 22 illustrates the medical connector 400 in a final, actuated state in which a needleless connector (not shown) has been fully advanced into the cavity 430 of the housing 410.

[0102] 21A and 21B, the medical connector 400 comprises a substantially cylindrical housing 410 having a distal wall 412, a proximal open end 414, a sidewall 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 cupped spring 350 (also known in the art as a Belleville spring) is disposed within the cavity 330, with the open distal end 352 of the cupped spring 350 adjacent the inner distal surface 422 of the distal wall 412 of the housing 410.

[0103] The cup-shaped spring 450 includes a frusto-conical disc body 452 having at least two prongs 456 extending from a proximal end 454 of the disc body 452. The dimensions of the frusto-conical shape of the disc body 452 generally determine the spring constant and characteristics, although the at least two prongs 456 may have different spring constants and characteristics relative to the disc body 452. In one or more embodiments, the at least two prongs 456 have a stiffer spring constant and characteristics relative to the disc body 452. In one or more embodiments, the at least two prongs 456 are stiff.

[0104] At least two prongs 456 extend proximally from the proximal end 454 of the disc body 452. Each of the at least two prongs 456 includes a proximal portion 458 and a distal portion 460 adjacent the proximal portion 458. The distal portion 460 forms an inner hook 462 that extends toward the center of the disc body 452. The inner hook 562 includes an inner edge 464 configured to engage with corresponding threads 82 of a corresponding needleless luer connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12 ). In one or more embodiments, an absorbent material 498 in the form of a disc is disposed within the cavity 430. The absorbent material 498 abuts the proximal face of the disc body 452.

[0105] 21A and 21B illustrate the medical connector 400 in an initial, unactuated state, while FIGS. 22A-22C illustrate the medical connector 400 in a final, actuated state in which the needleless connector (not shown) has been fully advanced into the cavity 430 of the housing 410. In operation, the hub 84 of a corresponding needleless connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12) is advanced into the cavity 430 of the housing 410. As the hub 84 contacts and advances against the disk body 452, the disk body 452 deforms from the initial state of FIGS. 21A and 21B to the final state of FIGS. 22A-22C. The disk body 452 deforms inward, pushing the proximal end 454 of the disk body 452 proximally, thereby advancing the at least two prongs 456 proximally and thereby further laterally advancing the inner hook 462. In the final state, the inner hook 462 latches onto the at least one thread 82, thereby locking the needleless connector 80 within the housing 410 via spring force. As shown in FIGS. 19 and 20 , in the fully advanced position, the proximal end 355 of the proximal portion 354 of the spring 350 engages a lower segment of the at least one thread 82 of the needleless connector 80, thereby locking the needleless connector 80 within the cavity 330 with a threaded and 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 irremovably locked within the cavity 330 by configurations of the spring 350, including, but not limited to, utilizing a stronger spring. The inner hook 456 in the fully advanced position creates a threaded and interference fit with the at least one thread 82 of the needleless connector 80. In one or more embodiments, the needleless connector 80 is removably locked within the cavity 430. In one or more embodiments, the needleless connector 430 is non-removably locked within the cavity 430 by the configuration of the spring 450, including, but not limited to, utilizing a stronger spring.

[0106] 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 the housing 310 from being reused.

[0107] As shown in Figures 22A-22C, in some embodiments, when the needleless connector 80 is fully advanced into the cavity 430 and the spring 450 engages the corresponding threads 82, an audible click or sound is produced that is detectable by the clinician or an auxiliary detection system to indicate that the needleless connector 80 has been fully advanced into the cavity 430.

[0108] As shown in FIG. 22A, 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-clip. In the fully advanced position, the set of tabs 453 interlock with the threads of the corresponding needleless connector 80. The set of tabs 653 engage the threads of the needleless connector 80 to irremovably 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 threads 82 and jump out of the thread path to prevent reuse.

[0109] As shown in FIGS. 22B and 22C, in some embodiments, the inner edge 464 is elongated in the outward and inward directions. In some embodiments, the inner edge 464 is configured as a c-clip. In the fully advanced position, the inner edge 464 interlocks with the threads of the corresponding needleless connector 80. The elongated inner edge 464 engages the threads of the needleless connector 80 to irremovably 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 unthread from the corresponding threads 82 and jump out of the thread path to prevent reuse.

[0110] A fifth embodiment of the present disclosure relates to a housing 510 of a medical connector 500. Figures 23A and 23B illustrate the medical connector 500 in an initial, unactuated state, and Figures 24A and 24B illustrate the medical connector 500 in a final, actuated state with a needleless connector (not shown) 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 integrated features that prevent reuse of the medical connector 500, as described in further detail below.

[0111] The medical connector 500 comprises a substantially cylindrical housing 510 having a distal wall 512, a proximal open end 514, a sidewall 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 disposed on an inner sidewall 518 of the cavity 530, the helical thread 550 extending at least partially the length of the inner sidewall 518.

[0112] At least one helical thread 550 includes a distal portion 552 integrally formed on the inner sidewall 518 and a frangible portion 554 proximal to the distal portion configured to detach and cross-thread upon threading and advancing corresponding threads 82 of a corresponding needleless luer connector 80 of one of the previous embodiments into the cavity (as seen in FIGS. 11 and 12). Upon removal of the luer connector 80, the frangible portion 554 does not return to its initial state, thereby preventing reuse of the housing 510.

[0113] In one or more embodiments, the frangible portion 554 in its initial state as shown in FIG. 23B does not follow the thread pattern of the at least one helical thread 550.

[0114] 23B, the frangible portion 554 has an approach angle φ that is greater than the approach angle ∂ of the distal portion 552 of the at least one helical thread 550. The greater approach angle φ is configured to cause deformation of the frangible portion 554. Deformation of the frangible portion 554 prevents reuse of the needleless connector 500 due to misalignment of the threads.

[0115] Even if the corresponding needleless luer connector 80 is removed, the angle φ of the frangible portion 554 does not return to its original state, and therefore the medical connector 500 cannot be reused.

[0116] Specifically, as shown in FIG. 24B, insertion and subsequent removal of the corresponding needleless luer connector 80 causes the frangible portion 554 to have a near-zero approach angle, thereby aligning the frangible portion 554 substantially parallel to the inner distal surface 522 of the housing 510.

[0117] In one or more embodiments, as specifically shown in Figure 23B, 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 a three-quarter turn.

[0118] In one or more embodiments, an absorbent material 599 is disposed within the cavity 530, the absorbent material 599 contacting the inner distal surface 522 of the housing 510. Insertion of a corresponding needleless connector 80 compresses the absorbent material 599, thereby releasing antiseptic into the cavity 530.

[0119] A sixth embodiment of the present disclosure relates to an insert 650 disposed within a housing 610 of a medical connector 600. Figures 25A and 25B illustrate an embodiment of the insert 650, and Figure 26 illustrates the medical connector 600 in an initial, unactuated state. In the final actuated state, a needleless connector (not shown) is fully advanced into the cavity 630 of the housing 610, as described in further detail below.

[0120] 25A and 25B, the insert 650 has a generally disk-shaped body 652 having a proximal surface 654 and a distal surface 656. Extending from the proximal surface 654 are at least two locking tabs 660, which extend distally from the distal surface 656 and away from the distal surface 656 of the disk-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 mate with corresponding threads 82 of the needleless luer connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12) upon advancement of the corresponding threads of the needleless luer connector through the cavity.

[0121] 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 therethrough. The center of the aperture 653 is concentric with the center of the disc-shaped body 652. As shown in FIG. 26 and described in further detail below, the aperture 653 is configured to non-removably interlock with the hooked protrusion 640 of the housing 610.

[0122] In one or more embodiments, the disc-shaped body 652 further includes a plurality of ridges 672 disposed on a sidewall 670 of the disc-shaped body 652. The plurality of ridges 672 extend inwardly into the disc-shaped body 652 from the sidewall 670 of the disc-shaped body 652. As shown in FIG. 26 and described in further detail below, the plurality of ridges 672 are configured to interlock with at least one tooth 634 of the housing 610.

[0123] In one or more embodiments, as shown in Figure 25B, the disc-shaped body 652 further includes a living hinge 676 disposed across the disc-shaped body 652. As shown in Figure 26, the living hinge 676 is configured to bend the disc-shaped body 652. The bending of the disc-shaped body 652 causes the at least two locking tabs 660 to become threaded onto the medical connector.

[0124] 26 , the medical connector 600 comprises a substantially cylindrical housing 610 having a distal wall 612, a proximal open end 614, a sidewall 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, an absorbent material (not shown) in the form of a disk is disposed within the cavity 630 and adjacent the inner distal surface 622 of the distal wall 612.

[0125] In one or more embodiments, hooked protrusion 640 extends concentrically from inner distal surface 622 of housing 610. Hooked protrusion 640 is configured to non-removably mate with opening 653 in disc-shaped body 652 upon full advancement of disc-shaped body 652 into cavity 630 of housing 610, thereby preventing medical connector 600 from being reused.

[0126] In one or more embodiments, at least one tooth 634 extends inwardly from the inner sidewall 618 into the cavity 630. The at least one tooth 634 is spaced a distance from the inner distal surface 622 of the housing 610. In one or more embodiments, the at least one tooth 634 is positioned substantially parallel to the proximal end 641 of the hooked protrusion 640. The at least one tooth 634 and the plurality of ridges 672 of the disk-shaped body 652 are configured to interdigitate with one another, and the at least one tooth 634 and the plurality of ridges 672 have substantially corresponding shapes. In one or more embodiments, the at least one tooth 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 disposed on the inner distal surface 622 of the housing 610.

[0127] 26 , the medical connector 600 is in an initial position. With full advancement of the corresponding needleless luer connector 80, the hooked protrusions 640 are received within the openings 653 of the disk-shaped body 652. However, full advancement is prevented by misalignment between the plurality of ridges 672 and the at least one tooth 634. Thus, full advancement can occur when the plurality of ridges 672 are aligned with the at least one tooth 634. In the final state, the insert 650 is irremovably locked with the hooked protrusions 640 received within the openings 653 of the disk-shaped body 652.

[0128] In one or more embodiments, an absorbent material (not shown) is disposed within the cavity 630, the absorbent material contacting the inner distal surface 622 of the housing 610. Insertion of a corresponding needleless connector 80 compresses the absorbent material, thereby releasing antiseptic into the cavity 630.

[0129] 27, a seventh embodiment of the present disclosure relates to a medical connector 700 including a housing 710 and an insert 750 disposed within the housing 710. As will be described in further detail below, the insert 750 is a resilient and flexible material and includes at least two living hinges 760 for gripping the threads 82 of a corresponding needleless luer connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12).

[0130] The housing 710 has a substantially cylindrical shape and includes a distal wall 712, a proximal open end 714, a sidewall 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, an absorbent material (not shown) in the form of a disk is disposed within the cavity 730 adjacent 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 inwardly directed hook.

[0131] The insert 750 comprises a C-shaped body 752 having a distal end 754 in the form of an arc and an open proximal end 756. Extending from the distal end 754 are two living hinges 760. The two living hinges 760 are in the form of cantilevered prongs. When a corresponding needleless luer connector 80 is advanced into the cavity 730, the C-shaped body 752, including the distal end 754 and the living hinges 760, deflects. The resilient material of the insert 750 causes the corresponding needleless luer connector 80 to be retained by the open proximal end 756 of the insert 750. The two living hinges 760 provide a counter force to the C-shaped body 752 of the insert.

[0132] In one or more embodiments, an absorbent material (not shown) is disposed within the cavity 730, the absorbent material adjacent the inner distal surface 722 of the housing 510. Insertion of a corresponding needleless connector 80 compresses the absorbent material, thereby releasing antiseptic into the cavity 730.

[0133] 28A and 28B, an eighth embodiment of the present disclosure relates to a medical connector 800 comprising a housing 810 and an insert 850 disposed within the housing 810. As will be explained in further detail below, the insert 850 is a resilient and flexible material, and at least two living hinges 860 grip the threads 82 of a corresponding needleless luer connector 80 of one of the previous embodiments (as seen in FIGS. 11 and 12).

[0134] The housing 810 has a substantially cylindrical shape and includes a distal wall 812, a proximal open end 814, a sidewall 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, an absorbent material (not shown) in the form of a disk is disposed within the cavity 830 and adjacent the inner distal surface 822 of the distal wall 812. In one or more embodiments, the distal wall 812 further protrudes inwardly.

[0135] In one or more embodiments, protrusion 840 extends concentrically from inner distal surface 822 of housing 810. Protrusion 840 is configured to non-removably mate with opening 853 of C-shaped body 852 upon full advancement of C-shaped body 852 into cavity 830 of housing 810, thereby preventing reuse of needleless connector 800. Protrusion 840 is configured to aid in aligning and advancing insert 850 into cavity 830 of housing 810.

[0136] In one or more embodiments, the inner wall 823 is spaced a distance from the inner distal surface 822 of the housing 810. The inner wall 823 further includes an opening 824 configured to receive a distal portion 854 of an insert 850, which is described in further detail below.

[0137] The insert 850 comprises a C-shaped body 852 having a distal portion 854 in the form of an arc and an open proximal end 856. At least two living hinges 860 extend tangentially to the distal portion 854. The two living hinges 860 are in the form of cantilevered prongs. When a 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 living hinges 860, deflects. The resilient material of the insert 850 causes the corresponding needleless luer connector 80 to be retained by the open proximal end 856 of the insert 850. The two living hinges 860 provide a counter force to the C-shaped body 852 of the insert.

[0138] In one or more embodiments, C-shaped body 852 further includes stem 857 having a cylindrical shape extending distally from distal portion 854. Extending from the stem is a bulbous protrusion 859. C-shaped body 852, stem 857, and bulbous protrusion 859 form a unitary body having an opening 861 extending therethrough. Opening 861 is configured to receive protrusion 840 of housing 810, while stem 857 and bulbous protrusion 859 are configured to interface with opening 824 of housing 810.

[0139] Advancement of a corresponding needleless luer connector 80 into cavity 830 deflects a C-shaped body 852, including a distal portion 854 and living hinges 860. The resilient material of insert 850 causes the corresponding needleless luer connector 80 to be held by open proximal end 856 of insert 850. Two living hinges 860 provide a counter force against C-shaped body 852 of the insert.

[0140] In one or more embodiments, an absorbent material (not shown) is disposed within the cavity 830, the absorbent material abutting the middle wall 823 of the housing 510. Insertion of a corresponding needleless connector 80 compresses the absorbent material, thereby releasing antiseptic into the cavity 830.

[0141] In one or more embodiments, the corresponding medical connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0142] In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male locking luer.

[0143] In some embodiments, the connector comprises a needleless injection site, sometimes referred to as a needleless injection port, hub, valve, or device, or a needleless access site, port, hub, valve, or device, including trademarks such as Clave® (available from ICU Medical, Inc.), SmartSite® (available from Cardinal Health, Inc.), and Q-Syte® (available from Becton, Dickinson, Company). In some embodiments, the cap can be connected to any of a variety of different needleless injection sites, such as those listed above. In one or more embodiments, after the needleless connector is mated with the connector, the connector remains uncontaminated while it is mated with the needleless connector, eliminating the need to disinfect the connector (e.g., treat with alcohol swabs) before each reconnection of the connector with another connector. The use of a needleless connector replaces standard wiping protocols for cleaning connectors.

[0144] Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. In one or more embodiments, the medical connector (100, 200, 300, 400, 500, 600, 700, 800) provides a protective cover to a corresponding needleless luer connector when engaged with the connector, as threads from the corresponding needleless luer connector engage and releasably connect with the medical connector (100, 200, 300, 400, 500, 600, 700, 800).

[0145] The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) are made from any of a number of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the medical connectors (100, 200, 300, 400, 500, 600, 700, 800) are constructed from polypropylene or polyethylene materials.

[0146] The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) can achieve disinfection when used with a luer connector by incorporating a disinfectant within the cavity (130, 230, 330, 430, 530, 630, 730, 830). The disinfectant or antimicrobial agent can be included directly in the absorbent material, or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam material that fills the cavity (130, 230, 330, 430, 530, 630, 730, 830). The medical connectors (100, 200, 300, 400, 500, 600, 700, 800) are designed to be compatible with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include various alcohols or chlorhexidine. In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antibacterial agent is a fluid or gel.

[0147] In one or more embodiments, the absorbent material is a nonwoven material, a foam, or a sponge. In certain embodiments, the absorbent material is a polyethylene foam. The foam may be open-cell, semi-open-cell, or closed-cell and may be molded, extruded, or die-cut from a sheet. In one or more embodiments, the absorbent reservoir material is molded, extruded, or die-cut from a sheet to form a cylindrical block shape.

[0148] The peelable seal minimizes the ingress of potential particulate hazards, provides a substantially impermeable enclosure for the medical connector (100, 200, 300, 400, 500, 600, 700, 800), provides a leak-proof and protective enclosure, protects the contents of the absorbent material contained within the cavity (130, 230, 330, 430, 530, 630, 730, 830), and / or maintains a sealed, sterile environment. The peelable seal provides a sufficient seal over a range of temperatures, pressures, and humidity levels. In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel back top. In certain embodiments, the peelable seal is heat-sealed or induction-sealed to the end face of the mating lid or the open end of the cap. In one or more embodiments, the peelable seal comprises a moisture barrier.

[0149] In some embodiments, the medical connector can be configured as a cap containing a disinfectant within a cavity in the housing, blocking the lumen of the corresponding medical connector to minimize the ingress of disinfectant and microbial agents into the connector, thereby reducing the risk of disinfectant and microbial agents entering the patient's bloodstream.

[0150] While the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, the disinfecting sponge can include any suitable disinfecting or other application-specific substance and can be made of any suitable material. Also, the inner and / or outer housing of the medical connector can be manufactured by one-off molding or other suitable process. Furthermore, the features or elements of the exemplary implementations of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination, 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.

[0151] Additionally, the accompanying drawings further illustrate non-limiting examples of certain exemplary embodiments of the present disclosure and aid in explaining the technology associated therewith. Any specific or relative dimensions or dimensions provided in the other drawings, such as those described above, are illustrative and not intended to be limiting.

[0152] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosure. That is, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0153] Although the present disclosure has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the invention. Therefore, it is intended that the present disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A medical connector, a housing having a radial protrusion extending from a substantially cylindrical housing body, and a cavity defined by a closed end, an open end, a partially cylindrical inner sidewall of the substantially cylindrical housing body, and a radial sidewall of the radial protrusion; a locking structure disposed on a side portion of the radial sidewall of the cavity, the locking structure including an angled tab; an insert advanceable into the cavity of the housing, the insert including a disk-shaped body having a distal surface, a proximal surface, a side wall, and a locking tab extending proximally from the side wall, the insert including at least one thread on an inner wall of the locking tab and a recessed notch located on a distal portion of an outer wall of the locking tab.

2. 2. The medical connector of claim 1, wherein the insert rotates from a first position to a locked position, the first position being defined by an inner portion of the radial sidewall, the locked position being defined by the side portion, and the side portion including the locking structure.

3. The medical connector of claim 1 , wherein the recessed notch of the insert engages a ledge of the angled tab of the locking structure when advanced over the angled tab.

4. The medical connector of claim 3 , wherein an audible click or sound occurs when the recessed notch advances past the ledge of the angled tab.

5. 10. The medical connector of claim 1, wherein the locking structure further comprises an outwardly facing sloped surface that slopes outward from an inward or left-hand position to an outward or right-hand position.

6. The medical connector of claim 5 , wherein the outwardly angled surface causes deformation of the locking tab.

7. 2. The medical connector of claim 1, wherein the locking structure further includes a proximal ramp located adjacent the proximal ramp ledge, the proximal ramp sloped inward relative to the radial sidewall from a distal position to a proximal position.

8. The medical connector of claim 1 , wherein the distal surface of the insert abuts an inner upper surface of the cavity of the housing when the insert is fully advanced into the cavity.

9. 2. The medical connector of 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 upper surface of the cavity of the housing, the absorbent material including a disinfectant.

10. 10. The medical connector of claim 9, wherein when the insert is advanced distally fully into the cavity, the distal surface of the insert and the inner upper surface of the cavity of the housing compress an absorbent material, causing the absorbent material to release a disinfectant.

11. The medical connector of claim 10 , wherein the antiseptic is retracted into the cavity by a gap defined by the partially cylindrical inner sidewall of the housing and the sidewall of the insert.

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

13. 2. The medical connector of claim 1, wherein a retention tab is disposed on an inner upper surface of the housing, the inner upper surface non-removably securing an opening disposed on the distal surface of the insert, the opening extending therethrough.

14. A medical connector, a housing having a radial projection extending from a substantially cylindrical housing body, and a cavity defined by a closed end, an open end, a partially cylindrical inner sidewall of the substantially cylindrical housing body, and a radial sidewall of the radial projection; a locking structure disposed on a side portion of the radial sidewall of the cavity, the locking structure including an angled tab; and an insert advanceable into the cavity of the housing, the insert including a disk-shaped body having a distal surface, a proximal surface, a side wall, and a locking tab extending proximally from the side wall, 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, the insert being advanced into the cavity by passing a corresponding medical connector through the cavity, the corresponding medical connector having at least one thread that mates with the at least one thread of the insert.

15. The medical connector of claim 14 , wherein the corresponding medical connector is removably threaded into the cavity.

16. A syringe, a housing projecting distally from a distal wall of a syringe barrel, the housing including a cavity defined by the distal wall of the syringe barrel, an open end opposite the distal wall, and a partially cylindrical sidewall extending from the distal wall to the open end, the housing further including a radial sidewall defined by a radial protrusion extending laterally from the housing, the radial protrusion and the radial sidewall being laterally arcuate, the radial sidewall being exterior to the distal wall of the housing; a tapered hub disposed within the cavity of the housing, the tapered hub extending distally from a distal wall of the syringe barrel, the tapered hub configured to interlock with a corresponding cavity in a housing of a vascular access device; a locking structure disposed on the radial sidewall including an outwardly sloping surface and an inclined tab, the outwardly sloping surface inclining from an inboard or left-hand position toward an outboard or right-hand position, the outwardly sloping surface extending at least a portion of a laterally projecting arc length of the radial sidewall, the inclined tab inclining outward from the outboard or right-hand position toward the inboard or left-hand position, the inclined tab including a ledge formed by a wall substantially perpendicular with respect to the radial sidewall; 1. An insert having a generally disc-shaped body having a proximal surface, a distal surface, a sidewall, a locking tab, and an opening, the locking tab extending from the distal surface, the opening being disposed on and extending through the proximal surface of the disc-shaped body, the insert further including at least one thread disposed on a wall of the locking tab; and a syringe, wherein a first position is defined by an inner or left portion of the radial sidewall, and a locked position is defined by the angled tab and the ledge, the housing being configured as a needleless connector capable of receiving a corresponding needleless fitting of a vascular access device, wherein when the insert is advanced proximally into the cavity of the housing, the locking tab is disposed in a first position such that the locking tab is elastically deformed outward relative to the radial sidewall.

17. 17. The syringe of claim 16, wherein the partially cylindrical sidewall has a substantially constant diameter.

18. 17. The syringe of claim 16, wherein the partially cylindrical sidewall includes an outward taper, the taper increasing in a distal direction toward the open end.

19. 17. The syringe of claim 16, wherein the locking tab is configured as a cantilevered prong having a proximal portion and a distal portion and is configured to deflect.

20. 20. The syringe of claim 19, wherein the locking tab further comprises an outer wall and an inner wall, the outer wall including a recessed notch adjacent a distal edge of the distal portion and extending proximally for at least a portion of the length of the distal portion.

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