Cap for pin and box fittings

Abstract

A cap for disinfecting a needleless connector is described herein. The cap includes a housing having a cavity and an insert disposed within the housing. The insert includes one or more cantilevered prongs disposed on a distal wall of the insert. The one or more cantilevered prongs are configured to flex when the needleless connector is inserted. On an outer lateral wall of the one or more cantilevered prongs are one or more bosses extending substantially at right angles to the one or more cantilevered prongs, the one or more bosses configured to push against a lateral wall of the housing to prevent further flexing of the one or more cantilevered prongs as the needleless connector is advanced.

Description

TECHNICAL FIELD

[0001] The present disclosure relates generally to a device for disinfecting and sterilizing access ports with, for example, male and female luer fittings, and in particular to a disinfecting and sterilizing device that can accommodate multiple types of connectors. Generally, the exemplary embodiments of the present disclosure relate to the field of threaded fittings, including medical caps and medical disinfecting caps, and in particular to caps and / or disinfecting caps for use with fluid luer connectors. BACKGROUND

[0002] Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. There are generally two types of vascular access devices: peripheral catheters and central venous catheters. When connected to a vascular access device for delivery of fluids or medications, bacteria and other microorganisms can enter the patient's vascular system from the access hub and port / valve. Each access hub (or port / valve or connection) is associated with a certain risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0003] To reduce CRBSI cases and ensure proper use and maintenance of vascular access devices, practice standards have been developed, including disinfecting and cleaning procedures.

[0004] Disinfecting caps have been added in the Society for Healthcare Epidemiology of America (SHEA) guidelines and the Infusion Nurses Standards (INS) guidelines.

[0005] In developed markets, when using an intravenous catheter, a needleless connector is typically used to close the system and then used to administer medication or other necessary fluids to the patient via the catheter. INS practice standards recommend the use of a needleless connector and state that it should be "continually and thoroughly disinfected with alcohol, iodine, or chlorhexidine gluconate / alcohol mixture prior to each use." Disinfecting the needleless connector ultimately aims to help reduce bacteria that can live on the surface and can cause various catheter-related complications, including CRBSI. Nurses typically complete this disinfection task by performing what is known as "scrubbing the hub" using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is typically low. In addition to the lack of compliance with "scrubbing the hub," through interviews with clinicians, it was noted that the scrubbing time, dry time, and number of scrubs to scrub the needleless connector often varied.

[0006] There are many risks of contact or contamination in a series of procedures associated with the transmission of microorganisms that can cause CRBSI. Contamination can occur during drug mixing, attachment of the cannula, and insertion of the access hub. Because the procedures connected to vascular access devices are so common and simple, the risks associated with accessing a patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is the nature of the clinician's effort to perform the connection, and this effort is largely uncontrolled.

[0007] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV), and hemodialysis lines employ different designs and are therefore limited to the type of connector that can have the cap attached. Currently, there are male disinfecting cap devices for disinfecting ISO 594-2 female threaded fluid luer connectors and female disinfecting cap devices for disinfecting ISO 594-2 male threaded fluid luer connectors. However, there is no single universal disinfecting cap device that has features that enable it to engage both male and female threaded connectors. Therefore, existing disinfecting caps are designed to fit only one type of connector and are specific to one particular size and / or shape of connector. Thus, there is a need for a disinfecting device that can accommodate multiple types of connectors, including male and female connectors, to simplify the disinfecting process.

[0008] There is also a need to provide a disinfecting cap that has proper mechanical fit and alignment for mating with a connector and to alert the user when full engagement and thus the full amount of disinfectant has been dispensed. SUMMARY

[0009] A first aspect of the present disclosure is directed to a cap comprising a generally cylindrical housing, a generally cylindrical insert, and one or more cantilevered prongs. The generally cylindrical housing has a distal wall, an open proximal end, and a sidewall having an inner surface and an outer surface, the inner surface, distal wall, and open proximal end defining a cavity of the housing. The generally cylindrical insert has an open proximal end and a closed distal end defining a distal wall having an inner surface and an outer surface, the insert removably disposed within the cavity of the housing, the outer surface of the distal wall of the insert abutting the distal wall of the housing. The one or more cantilevered prongs protrude from the inner surface of the distal wall of the insert, the one or more cantilevered prongs having a sidewall, the one or more cantilevered prongs configured to flex to facilitate an interference fit between the insert and a mating feature of a needleless connector. The cavity of the insert is defined by the inner surface of the insert, the sidewall of the one or more cantilevered prongs, and the open proximal end of the insert. One or more tabs extend perpendicularly at a substantially right angle to the one or more cantilevered prongs, the one or more tabs configured to push against the sidewall of the housing to prevent further flexing of the one or more cantilevered prongs as the needleless connector is advanced. The cap further comprises an absorbent material.

[0010] In one or more embodiments, the syringe further comprises a centering feature of the housing disposed within the cavity of the housing. The centering feature protrudes from the distal wall of the housing, the centering feature of the housing configured to interdigitate with a corresponding centering feature of the insert when the insert is inserted into the cavity of the housing.

[0011] In one or more embodiments, the centering feature of the insert causes the outer surface of the insert to extend partially into the distal wall of the insert, the centering feature being an annular channel.

[0012] In one or more embodiments, the one or more cantilevered prongs are separated by a gap. In one or more embodiments, the one or more cantilevered prongs are unitary cylindrical bodies.

[0013] In one or more embodiments, the one or more tabs are disposed over at least a portion of a length of the one or more cantilevered prongs.

[0014] In one or more embodiments, the one or more tabs include a support rib positioned beneath the one or more tabs and secured to the one or more cantilevered prongs, the support rib configured to provide rigidity to the one or more tabs.

[0015] In one or more embodiments, the disinfectant is absorbed in an absorbent material. In one or more embodiments, the absorbent material is disposed within a cavity of the housing, the absorbent material disposed between an outer surface of a distal wall of the housing and a distal wall of the insert.

[0016] In one or more embodiments, the absorbent material is disposed within a cavity of the insert.

[0017] In one or more embodiments, advancing a needleless connector into the cavity of the insert causes compression of the absorbent material, thereby releasing the disinfectant.

[0018] In one or more embodiments, a diameter of the cavity of the housing is greater than a diameter of the insert.

[0019] In one or more embodiments, disinfectant leaks out between an inner surface of a sidewall of the housing and the insert.

[0020] In one or more embodiments, a distal wall of the insert has a diameter R2 and the one or more cantilevered prongs have a diameter Rl, the diameter R2 of the distal wall being greater than the diameter Rl of the one or more cantilevered prongs.

[0021] In one or more embodiments, a collar of a needleless connector is inserted into a gap formed between the one or more cantilevered prongs and a sidewall of the housing.

[0022] In one or more embodiments, the insert is configured to engage a female connector relative to its inner sidewall and to engage a male connector relative to its outer sidewall.

[0023] In one or more embodiments, an inner sidewall of the one or more cantilevered prongs includes at least one internal thread configured to mate with a thread of a needleless connector.

[0024] In one or more embodiments, the at least one internal thread is configured to mate with a male needleless connector. In one or more embodiments, at least one external thread is configured to mate with a female needleless connector. BRIEF DESCRIPTION OF DRAWINGS

[0025] Figure 1 exploded view of a cap illustrating example embodiments in accordance with the present disclosure;

[0026] Figure 2A exploded view of a cap illustrating example embodiments in accordance with the present disclosure; Figure 1

[0027] Figure 2B exploded view of a cap illustrating example embodiments in accordance with the present disclosure; Figure 1 ​​

[0028] Figure 2C Example illustration Figure 2B side view cross-section of the housing of

[0029] Figure 3 Example illustration Figure 1 exploded view of the cap of

[0030] Figure 4 Example illustration Figure 1 side view perspective of the insert of the cap of

[0031] Figure 5 Example illustration Figure 1 side view cross-section of the insert of

[0032] Figure 6 Example illustration Figure 1 side view of the insert of

[0033] Figure 7 Example illustration Figure 1 top view perspective of the insert of

[0034] Figure 8 Example illustration Figure 1 side view cross-section of the insert disposed within the housing of

[0035] Figure 9 Example illustration Figure 1 perspective cross-section of the insert disposed within the housing of

[0036] Figure 10 Example illustration Figure 1 bottom view perspective of the insert disposed within the housing of

[0037] Figure 11 Example illustration Figure 1 bottom view of the insert disposed within the housing of

[0038] Figure 12A Example illustration Figure 1 exploded view of the insert and needleless connector of

[0039] Figure 12B Example illustration Figure 1 the insert partially disposed within the needleless connector of DETAILED DESCRIPTION

[0040] Embodiments of the present disclosure relate to a sterile universal cap for connecting to and for disinfecting medical connectors or needleless connectors, including male and female connectors. The male and female connectors can be male and female luer connectors. The cap can further include an absorbent material, a disinfectant or antimicrobial agent, and a peelable seal and / or septum. The cap provides a mechanical barrier for the connector and houses an antimicrobial agent for disinfection. The cap of the present disclosure enables a physician to simplify the disinfection process.

[0041] With respect to the terms used in the present disclosure, the following definitions are provided.

[0042] The use of "a" and "an" and "the" as used in this text are used indiscriminately and include singular and plural.

[0043] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection caused by the presence of a catheter or intravenous line.

[0044] As used herein, the term "luer connector" refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, intravenous tubing, etc. to each other. Luer connectors consist of a male interlocking tube and a female interlocking tube that are slightly tapered so as to hold together better with just a simple pressure / twist fit. Luer connectors can optionally include an additional threaded rim, enabling them to be more secure. The male end of a luer connector is typically associated with a flush syringe and can interlock and connect to the female end on a vascular access device (VAD). The luer connector includes a distal end, a proximal end, an irregularly shaped outer wall, a shaped central passage for fluid communication from the chamber of the barrel of the syringe to the port of the vascular access device. The luer connector also has a distal end passage that releasably attaches the luer connector to the port of the vascular access device and a proximal end passage that releasably attaches the luer connector to the barrel of the syringe.

[0045] As will be readily appreciated by one skilled in the relevant arts, although descriptive terms such as "lock," "end," "port," "thread," "sponge," "prong," "projection," "tab," "wall," "top," "side," "bottom," and other terms are used in this specification to facilitate understanding, no limitation is intended on any of the components that can be used in combination or alone to practice aspects of embodiments of the present disclosure.

[0046] The embodiments illustrated in this specification are provided to illustrate exemplary embodiments of the present disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the present disclosure. Moreover, descriptions of well-known functions and constructions are omitted for the sake of clarity and conciseness.

[0047] Exemplary embodiments of the present disclosure provide a cap that can reduce the number of types of devices and logistics currently required in a hospital environment for connecting, capping, and / or disinfecting male and female threaded fluid luer connectors by about half by including features in a single cap or device that enable it to be used with both male and female threaded fittings.

[0048] In exemplary implementations of embodiments of the present disclosure, the cap, connector cap, or disinfecting cap includes integral threads (one or more), and any and all other features that enable it to interface with both male and female threaded fittings.

[0049] According to further exemplary implementations of embodiments of the present disclosure, the configuration of the structural elements that make up the cap includes one or more cantilevered prongs disposed in the interior cavity of the cap that include internal threads to connect to the threads of a female medical connector and external threads to connect to the threads of a male medical connector to facilitate securing the cap to either a female fitting or a male fitting, respectively.

[0050] According to further exemplary implementations of embodiments of the present disclosure, the male and female threads coincide with each other on the inner and outer faces of the threaded protrusions.

[0051] According to further exemplary implementations of embodiments of the present disclosure, the cantilevered prongs can be in the form of protrusions and can be split-thread type, wherein the protrusions can be bent or deflected to allow for better interference fit compliance with the fittings.

[0052] According to further exemplary implementations of embodiments of the present disclosure, one or more bosses can be provided on the cantilevered prongs to limit the deflection angle of the cantilevered prongs to increase the security of the interface when the disinfecting cap is connected to either a male or female connector.

[0053] According to further exemplary implementations of embodiments of the present disclosure, the female threads are of a suitable size and thread pattern to interface with a standard ISO 594-2 type male fitting, and / or the male threads are of a suitable size and thread pattern to interface with a standard ISO 594-2 type female fitting. One example of an ISO 594-2 type fitting is a Q-type fitting.

[0054] In one or more embodiments, the female connector may be selected from the group consisting essentially of needleless connectors, catheter Luer connectors, stopcock valves, and hemodialysis connectors. In one or more embodiments, the needleless connector is selected from Q-Syte connectors, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClaveClear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc.

[0055] In one or more embodiments, the male connector may be an intravenous catheter end, a stopcock valve, or a male lock Luer connector.

[0056] Before describing several exemplary embodiments of this disclosure, it should be understood that this disclosure is not limited to the details of the construction or process steps set forth in the following description. This disclosure can have other embodiments and can be practiced or performed in various ways.

[0057] Referring now to the accompanying drawings, in which the same reference numerals represent the same or corresponding parts in various views, embodiments of the present disclosure are described below.

[0058] Figure 1 The example illustrates an exploded view of a disinfection cap 100. The disinfection cap 100 includes an insert 150 removably disposed within a housing 120. In one or more embodiments, an absorbent material 192 is disposed within the insert 150. The absorbent material 192 contains a disinfecting fluid or gel.

[0059] like Figures 2A to 2C As shown, the housing 120 is generally cylindrical in shape, including a generally cylindrical sidewall 122, a distal sidewall 124, and an open proximal end 126. The sidewall 122 includes an inner surface 128 and an outer surface 130. A cavity 132 is defined by the distal sidewall 124, the open proximal end 126, and the inner surface 128. In one or more embodiments, the outer surface 130 of the sidewall 122 includes a plurality of gripping members 134. The open proximal end 126 of the housing 120 includes an engagement surface 136 on which a removable, peelable seal 190 is disposed.

[0060] In one or more embodiments, a peelable seal 190 is disposed on the engagement surface 136 of the open proximal end 126 of the housing 120 to prevent the egress of the disinfectant or antiseptic from the cavity 132. In instances where the absorbent material 192 is fully inserted into the cavity 132 of the housing 120, the peelable seal 190 can be affixed to the engagement surface of the open proximal end 126 of the housing 120. The peelable seal 190 minimizes the ingress of potential particulate hazards, provides a substantially impermeable closure for the cap 100, provides a leak-proof protective enclosure, protects the contents of the absorbent material 192 contained within the cavity 132, and / or maintains a sealed, sterile environment. The peelable seal 190 provides a sufficient seal under a range of temperature, pressure, and humidity levels.

[0061] In another exemplary embodiment, one or more disinfecting members, such as the absorbent material 192, are disposed within the cavity 132 in the form of a sponge and / or an isopropyl alcohol (IPA) soaked sponge. In one or more embodiments, the absorbent material 192 can also be formed together as a single cleaning member or separate cleaning members disposed within the cavity 132.

[0062] In one or more embodiments, as best shown in Figure 2B and 2C The centering feature 138 is disposed within the cavity 132, the centering feature 138 extending from the distal wall 124. As shown, the centering feature 138 is in the form of a raised ring that centers on the distal wall 124 of the housing 120. In one or more embodiments, the raised ring of the centering feature 138 has a chamfered wall. In one or more embodiments, the raised ring of the centering feature 138 has a rounded wall. The centering feature 138 of the housing 120 is configured to intermate with a corresponding centering feature (not shown) of the insert 150 when the insert 150 is advanced or inserted into the cavity 132 of the housing 120, as discussed in further detail below.

[0063] As best shown in Figure 3 and 8As shown in FIG. 1, the insert 150 can be advanced or inserted into the cavity 132 of the housing 120 along the longitudinal direction. Upon full advancement, the insert 150 abuts the distal wall 124 of the housing 120. In one or more embodiments, an absorbent material 192 is disposed within the cavity 132 of the housing 120. In one or more embodiments, advancement of the insert 150 causes longitudinal compression of the absorbent material 192, thereby dispensing the sterilant absorbed by the absorbent material 192. In one or more embodiments, the needleless connector is advanced along the longitudinal direction to contact the insert 150 and subsequently cause longitudinal compression of the absorbent material 192, thereby dispensing the sterilant. In one or more embodiments, the diameter of the cavity 132 of the housing 120 is greater than the diameter of the insert 150, thereby permitting the dispensed sterilant to escape between the inner surface 128 of the sidewall 122 of the housing 120 and the insert 150.

[0064] As shown in FIG. 1, the insert 150 can be advanced or inserted into the cavity 132 of the housing 120 along the longitudinal direction. Upon full advancement, the insert 150 abuts the distal wall 124 of the housing 120. In one or more embodiments, an absorbent material 192 is disposed within the cavity 132 of the housing 120. In one or more embodiments, advancement of the insert 150 causes longitudinal compression of the absorbent material 192, thereby dispensing the sterilant absorbed by the absorbent material 192. In one or more embodiments, the needleless connector is advanced along the longitudinal direction to contact the insert 150 and subsequently cause longitudinal compression of the absorbent material 192, thereby dispensing the sterilant. In one or more embodiments, the diameter of the cavity 132 of the housing 120 is greater than the diameter of the insert 150, thereby permitting the dispensed sterilant to escape between the inner surface 128 of the sidewall 122 of the housing 120 and the insert 150. Figures 4 to 7 As shown in FIG. 1, the insert 150 can be advanced or inserted into the cavity 132 of the housing 120 along the longitudinal direction. Upon full advancement, the insert 150 abuts the distal wall 124 of the housing 120. In one or more embodiments, an absorbent material 192 is disposed within the cavity 132 of the housing 120. In one or more embodiments, advancement of the insert 150 causes longitudinal compression of the absorbent material 192, thereby dispensing the sterilant absorbed by the absorbent material 192. In one or more embodiments, the needleless connector is advanced along the longitudinal direction to contact the insert 150 and subsequently cause longitudinal compression of the absorbent material 192, thereby dispensing the sterilant. In one or more embodiments, the diameter of the cavity 132 of the housing 120 is greater than the diameter of the insert 150, thereby permitting the dispensed sterilant to escape between the inner surface 128 of the sidewall 122 of the housing 120 and the insert 150.

[0065] In alternative embodiments, the one or more cantilevered prongs 162 are a unitary cylindrical body, wherein there is no gap 184 separating portions of the unitary cylindrical body. In one or more embodiments, the insert has a unitary body without any gap 184, the unitary body including any number of prongs that are the same and / or different (in any dimensional feature, such as length, width, thickness, or shape) as long as the insert is configured to engage a female connector relative to its inner surface and a male connector relative to its outer surface.

[0066] In one or more embodiments, the inner sidewall 166 of the one or more cantilever forks 162 includes at least one internal thread 170 configured to engage with a female pinless connector. In one or more embodiments, the outer sidewall 168 of the one or more cantilever forks 162 includes at least one external thread 172 configured to engage with a male pinless connector. In one or more embodiments, the at least one internal thread 170 and the at least one external thread 172 are helical.

[0067] like Figure 5 As shown, the at least one internal thread 170 may be contained on the inner sidewall 166 of the one or more cantilever forks 162, and the at least one internal thread 170 is sufficient to interlock with the mating features of a needleless connector. In one or more embodiments, the at least one internal thread 170 has dimensions and pitch for engaging with the threaded section of a needleless connector (e.g., a female Luer connector). Such connectors are typically and generally used as catheters and other fluid-impermeable protective connectors in medical applications. In one or more embodiments, when the threads of the female Luer connector engage with the at least one internal thread 170 and form a releasable connection, the cap 100 provides a protective cover for the female Luer connector when engaged with it.

[0068] In another exemplary embodiment, the profiles of the at least one internal thread 170 and / or the inner sidewall 166 may be substantially parallel to or coincide with the profiles of the at least one external thread 172 and / or the outer sidewall 168, respectively.

[0069] like Figure 5 and 6 As shown, in one or more embodiments, the one or more cantilever forks 162 have a distal portion 180 and a proximal portion 182, the distal portion 180 having a wall thickness greater than the proximal portion 182. The respective wall thicknesses of the distal portion 180 and the proximal portion 182 are defined as the distance between the inner wall 166 and the outer wall 168 of the one or more cantilever forks 162. In one or more embodiments, the outer wall gradually tapers inward from the distal portion 180 to the proximal portion 182.

[0070] The cavity 164 of the insert 150 is defined by the distal wall 156, the inner side walls 166 of the one or more cantilevered prongs 162, and the open proximal end 152. The cavity 164 is configured to receive a needleless connector, such as a female luer connector. In one or more embodiments, the inner side walls 166 of the cantilevered prongs 162 include at least one internal thread 170 configured to mate with threads of a female needleless connector. In one or more embodiments, the at least one internal thread 170 extends from the open proximal end 152 at least a partial length of the one or more cantilevered prongs 162. In one or more embodiments, the at least one internal thread 170 extends from the open proximal end 152 to the distal wall 156.

[0071] As best shown in Figure 6 The distal wall 156 has a diameter R2, and the distal portions 180 of the one or more cantilevered prongs 162 have a diameter Rl. The diameter R2 of the distal wall 156 is greater than the diameter Rl of the distal portions 180 of the one or more cantilevered prongs 162, such that the one or more cantilevered prongs 162 extend from the inner surface 158 of the distal wall 156, rather than from an edge of the distal wall 156. As shown in Figure 8 This configuration allows a collar of a needleless connector to be inserted into a gap 184 formed between the outer side walls 168 of the one or more cantilevered prongs 162 and the inner surface 128 of the side wall 122 of the housing 120, as shown in

[0072] Referring to Figures 7 to 10 The centering feature 174 of the insert 150 is disposed on the outer surface 160 of the distal wall 156 of the insert 150, with the centering feature 138 extending partially into the distal wall 156 from the outer surface 160. As shown, the centering feature 174 is in the form of an annular channel that centers on the distal wall 156 of the insert 150. In one or more embodiments, the channel of the centering feature 174 has a chamfered wall. In one or more embodiments, the channel of the centering feature 174 has a rounded wall. The centering feature 174 of the insert 150 is configured to intermate with a corresponding centering feature 138 of the housing 120, which is disposed on the inner surface 128 of the distal wall 124 of the housing 120, as the insert 150 is longitudinally advanced or inserted into the cavity 132 of the housing 120.

[0073] As best shown in Figures 8 to 10As shown in FIG. 1, the insert 150 is fully disposed within the cavity 132 of the housing 120. The insert 150 has a length from the open proximal end 152 to the distal end 154 that is less than the length of the cavity 132 of the housing 120 such that the insert 150 does not protrude beyond the cavity 132 of the housing 120. Compression of the absorbent material 192 in the longitudinal direction toward the distal wall 124 of the housing 120 when connected to a female or male luer connector allows the female or male luer connector to contact the disinfectant or antimicrobial to disinfect the female or male luer connector.

[0074] Referring now to the drawings Figures 3 to 11 The insert 150 further includes one or more tabs 176. The one or more tabs 176 extend substantially perpendicularly at a right angle to the one or more cantilevered prongs 162 of the insert 150. The one or more tabs 176 are disposed at a distance from the distal wall 156 along the one or more cantilevered prongs 162 and at least partially protrude therefrom.

[0075] The one or more tabs 176 increase the mechanical engagement of the needle-free connector with the cap 100. When the needle-free connector is mechanically secured to the insert 150, the one or more cantilevered prongs 162 are pushed radially outward. As a result, the one or more tabs 176 are pushed against the sidewall 122 of the housing 120 to prevent further radial movement or deflection of the one or more cantilevered prongs 162. The resistance from the one or more tabs 176 increases the torque requirement and separation force to disengage the needle-free connector from the cap, thereby improving the securement of the cap 100 on the needle-free connector. The resistance can be noticed by the user, thereby informing the user that the needle-free connector has advanced sufficiently into the final position where the disinfectant is fully dispersed from the absorbent material due to the compression of the absorbent material 192. Additionally, the one or more tabs 176 move radially outward equally towards the sidewall 122 of the housing 120 to improve the alignment of the cap 100 when secured to the medical connector. Furthermore, the one or more tabs 176 can prevent further engagement of the mechanical connection between the two components. The one or more tabs 176 prevent further threading engagement between the cap 100 and the needle-free connector. The one or more tabs 176 engaged with the medical connector will alert the user that the full engagement between the threads of the threaded insert and the threads of the needle-free connector is secure. In one or more embodiments, the one or more tabs 176 engage with the needle-free connector and act as a physical stop to prevent further advancement of the needle-free connector into the cavity and thus will alert the user that the full engagement between the threads of the threaded insert and the threads of the needle-free connector is secure. The one or more tabs 176 limit the angle of deflection of the one or more cantilevered prongs 162, thereby increasing the security of the engagement when the cap 100 is connected to the needle-free connector. The placement distance of the one or more tabs 176 on the one or more cantilevered prongs 162 can be configured to limit the desired angle of deflection.

[0076] In one or more embodiments, the one or more tabs 176 are transverse to the one or more cantilevered prongs 162. The length of the one or more tabs 176 extends fully across the arc length of the one or more cantilevered prongs 162 of the insert 150.

[0077] As shown in FIG. 1 1, in one or more embodiments, the one or more tabs 176 include a support rib 178 positioned below the one or more tabs 176 and secured to the one or more cantilevered prongs 162 of the insert 150. The support rib 178 is configured to provide rigidity to the one or more tabs 176. In one or more embodiments, the support rib 178 is integral with the one or more tabs 176. In a preferred embodiment, the one or more tabs 176 are supported by the one or more support ribs 178. Figure 7 As shown in FIG. 1 1, in one or more embodiments, the one or more tabs 176 include a support rib 178 positioned below the one or more tabs 176 and secured to the one or more cantilevered prongs 162 of the insert 150. The support rib 178 is configured to provide rigidity to the one or more tabs 176. In one or more embodiments, the support rib 178 is integral with the one or more tabs 176. In a preferred embodiment, the one or more tabs 176 are supported by the one or more support ribs 178.

[0078] The one or more cantilevered prongs 162 and / or the insert 150 can have different shapes, including but not limited to a trapezoidal shape, an inverted trapezoidal shape, a shape with a convex inner surface (e.g., a parabolic shape), a shape with a concave inner surface, or a shape with a straight profile (i.e., a cylindrical or semi-conical shape). In one or more embodiments, the one or more cantilevered prongs taper inwardly from the distal wall 156 of the insert toward the open proximal end. In one embodiment, the insert 150 is integrally formed with the housing 120 and positioned within the cavity 132 of the housing 120.

[0079] Figure 12A and 12B The insert 150 is shown engaging with the needleless connector 194. The housing 120 is not shown for illustrative purposes, however it should be understood that the needleless connector 194 is ultimately covered by the housing 120. The one or more bosses 176 disposed on the one or more cantilevered prongs 162 are configured to limit the depth to which the needleless connector 194 can be threaded or inserted into the insert. The needleless connector 194 is threaded onto the insert 150 and the one or more bosses 176 disposed on the one or more cantilevered prongs 162 control or limit the depth to which the needleless connector 194 can be threaded onto the insert 150 as the one or more bosses 176 mechanically abut the needleless connector 194 when the desired insertion is achieved.

[0080] In one or more embodiments, the absorbent material 192 is radially compressed by the inner sidewall 166 of the insert 150 to retain the absorbent material 192 in the cavity 164 of the insert 150.

[0081] The cap 100 can achieve disinfection when used on a needleless connector or luer connector by adding a disinfectant or antimicrobial agent to the cavity 132 of the cap 100. The disinfectant or antimicrobial agent can be included directly in the cavity 132 or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam material, such as the absorbent material 192, that fills the chamber of the cap 100. The cap 100 is configured to be compatible when interacting with a variety of disinfectants.

[0082] The housing 120 and the insert 150 are made from any of a variety of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the housing 120 includes a polypropylene or polyethylene material.

[0083] With reference to the drawings, in one or more embodiments, a peelable seal 190 is disposed on the engagement surface of the open proximal end 126 of the housing 120 to prevent the exit of the sterilant or antimicrobial agent from the cavity 132. The peelable seal 190 can be secured to the engagement surface of the open proximal end 126 of the housing 120 with the absorbent material 192 properly inserted into the cavity 132 of the cap 100. The peelable seal 190 minimizes the ingress of potential particulate hazards and also provides a substantially impermeable closure for the cap 100, a leak-proof protective closure, protection of the contents of the absorbent material contained within the cavity 132, and / or maintenance of a sealed, sterile environment. The peelable seal 190 provides a sufficient seal at a range of temperature, pressure, and humidity levels.

[0084] In one or more embodiments, the peelable seal 190 includes an aluminum or multi-layer polymer film peel top. In particular embodiments, the peelable seal 190 is heat sealed or induction sealed to the end face of the locking cap or open end of the cap. In one or more embodiments, the peelable seal 190 includes a moisture barrier layer.

[0085] In one or more embodiments, the peelable seal 190 includes an aluminum or multi-layer polymer film peel top. In particular embodiments, the peelable seal 190 is heat sealed or induction sealed to the open end of the cap. In one or more embodiments, the peelable seal 190 includes a moisture barrier layer. In one or more embodiments, the peelable seal 190 is thin enough to be pierced by a needleless connector so that the needleless connector can be inserted or advanced into the housing 120 without having to first remove the peelable seal 190.

[0086] In one or more embodiments, the absorbent material 192 is a nonwoven material, a foam, or a sponge. In particular embodiments, the foam is a polyurethane foam. In particular embodiments, the absorbent material 192 is in the form of a foam plug. In one or more embodiments, the absorbent material 192 includes one or more slits.

[0087] In one or more embodiments, the insert 150 and the housing 120 can be bonded together by ultrasonic welding or solvent-resistant biocompatible adhesive. In one or more embodiments, the insert 150 and the housing 120 can also be interlocked by a friction fit or a snap fit.

[0088] The cap 100 can achieve disinfection when used on a luer connector by adding a disinfectant or antimicrobial agent to the cavity 132 of the housing 120 and / or the cavity 164 of the insert 150. The disinfectant or antimicrobial agent can be included directly in the cavity 132 of the housing 120 and / or the cavity 164 of the insert 150, or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam material that fills the cavity 132 of the housing 120 and / or the cavity 164 of the insert 150. The cap 100 is configured to be compatible when interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include a variation of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine acetate, chlorhexidine gluconate, povidone-iodine, ethyl alcohol, dichlorobenzyl alcohol, dehydroacetic acid, octonidine, triclosan, hydrogen peroxide, colloidal silver, benzalkonium chloride, benzethonium chloride, octenidine, antibiotics, and mixtures thereof. In particular embodiments, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine acetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

[0089] According to the exemplary embodiments shown in Figure 12A and 12B , for example, after the peelable seal 190 is removed or punctured, the housing 120 can receive a tip or interface of a needleless connector. For example, a female needleless connector or luer connector having a collar and a tip is received within the cavity 132 of the housing 120 and the cavity 164 of the insert 150, with the tip advanced within the cavity 164 of the insert 150 and the collar received within the cavity 132 of the housing 120. In the case where the insert 150 is disposed within the cavity 132 of the housing 120, the collar is disposed between the one or more cantilevered prongs 162 of the insert 150 and the sidewall 122 of the housing. For example, a male luer connector or stopcock is received within the cavity 132 of the housing. In the case where the insert 150 is disposed within the cavity 132, the male luer connector is disposed between the one or more cantilevered prongs 162 of the insert 150 and the sidewall 122 of the housing. The at least one internal thread 170 and / or the at least one external thread 172 are configured to match and secure threads of the male or female luer connector. In one or more embodiments, such threads of the male or female luer connector can be one or more protrusions, lugs, and / or threads.

[0090] As shown in Figure 12BAs shown in FIG. 1 1, when the needleless connector 194 is fully advanced into the cap 100, the one or more bosses 176 abut the collar 196 of the needleless connector 194, thereby preventing further advancement of the needleless connector 194 into the cap 100. When the needleless connector 194 is fully advanced, the housing (not shown) of the cap 100 encases the collar 196. In operation, advancing the needleless connector into the cavity 164 of the insert 150 causes compression of the absorbent material 192, thereby releasing the disinfectant as the absorbent material 192 is compressed. In one or more embodiments, the absorbent material 192 is disposed within the cavity 132 of the housing, the absorbent material 192 is disposed between the distal wall 124 of the housing and the insert 150, such that advancing the needleless connector into the cavity 164 causes the insert 150 to compress the absorbent material 192 against the distal wall 124 of the housing 120. In one or more embodiments, the absorbent material 192 is disposed within the cavity 164 of the insert 150, such that advancement of the needleless connector causes the absorbent material 192 to be compressed against the distal wall 156 of the insert 150.

[0091] While the present disclosure has been illustrated and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, the disinfecting sponge can include any suitable disinfecting substance or other application-specific substance and can be made of any suitable material. Further, the inner housing and / or the outer housing of the cap can be single-shot molded or made by other suitable processes. Further, as will be readily appreciated by those skilled in the art, any of the features or elements of any of the exemplary implementations of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination (one or more).

[0092] In addition, the accompanying drawings further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of the technology associated therewith. In addition to the above, any specific or relative dimensions or measurements provided in the drawings are exemplary, not limiting.

[0093] Reference throughout this specification to "an embodiment", "certain embodiments", "one or more embodiments" or "embodiments" means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. The appearances of the phrases "in one or more embodiments", "in certain embodiments", "in one embodiment" or "in an embodiment" in various places in the specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics can be combined in any suitable manner in one or more embodiments.

[0094] While the disclosure herein 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 thus be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatuses of the present disclosure without departing from the spirit and scope of the disclosure. It is therefore intended that the present disclosure include modifications and variations as come within the scope of the appended claims and their equivalents.

Claims

1. A cap comprising: a generally cylindrical housing having a distal wall, an open proximal end, and a sidewall having an inner surface and an outer surface, the inner surface, the distal wall, and the open proximal end defining a cavity of the housing; a generally cylindrical insert having an open proximal end and a closed distal end defining a distal wall having an inner surface and an outer surface, the insert being removably disposed within the cavity of the housing, the outer surface of the distal wall of the insert abutting the distal wall of the housing; one or more cantilevered prongs projecting from the inner surface of the insert, the one or more cantilevered prongs having a sidewall defining a length, the one or more cantilevered prongs being configured to flex to facilitate an interference fit between a mating feature of the insert and a needleless connector; and a cavity of the insert defined by the inner surface of the insert, the sidewall of the one or more cantilevered prongs, and the open proximal end of the insert, an absorbent material; wherein the cap further comprises a centering feature of the housing disposed within the cavity of the housing; wherein the centering feature projects from the distal wall of the housing, the centering feature of the housing being configured to intermate with a corresponding centering feature of the insert when the insert is inserted into the cavity of the housing; wherein the centering feature of the insert causes the outer surface of the insert to extend partially into the distal wall of the insert, the centering feature of the insert being an annular channel.

2. The cap of claim 1, wherein The one or more cantilevered prongs are separated by a gap.

3. The cap of claim 1, wherein The one or more cantilevered prongs are a unitary cylindrical body.

4. The cap of claim 1, wherein A disinfectant is absorbed within the absorbent material.

5. The cap of claim 4, wherein The absorbent material is disposed within the cavity of the housing, the absorbent material being disposed between the distal wall of the housing and the outer surface of the distal wall of the insert.

6. The cap of claim 5, wherein Advancing the insert into the cavity of the housing causes compression of the absorbent material, thereby releasing a disinfectant.

7. The cap of claim 1, wherein The absorbent material is disposed within the cavity of the insert.

8. The cap of claim 7, wherein Advancing a needleless connector into the cavity of the insert causes compression of the absorbent material, thereby releasing a disinfectant.

9. The cap of claim 1, wherein The diameter of the cavity of the housing is greater than the diameter of the insert.

10. The cap of claim 9, wherein A disinfectant leaks between the inner surface of the sidewall of the housing and the insert.

11. The cap of claim 1, wherein The distal wall of the insert has a diameter R2 and the one or more cantilevered prongs have a diameter Rl, the diameter R2 of the distal wall being greater than the diameter Rl of the one or more cantilevered prongs.

12. The cap of claim 11, wherein A collar of a needleless connector is inserted into the gap formed between the one or more cantilevered prongs and the sidewall of the housing.

13. The cap of claim 1, wherein The insert is configured to engage a female connector relative to its inner sidewall and a male connector relative to its outer sidewall.

14. The cap of claim 13, wherein The inner sidewall of the one or more cantilevered prongs includes at least one internal thread configured to mate with a thread of a needleless connector.

15. The cap of claim 1, further comprising one or more tabs extending perpendicularly substantially at right angles to the one or more cantilevered prongs, the one or more tabs configured to push against a sidewall of the housing to stop the one or more cantilevered prongs from further bending as the needleless connector advances.

16. The cap of claim 15, wherein The one or more tabs are disposed over at least a portion of a length of the one or more cantilevered prongs.

17. The cap of claim 15, wherein The one or more tabs include a support rib positioned below the one or more tabs and secured to the one or more cantilevered prongs, the support rib configured to provide rigidity to the one or more tabs.

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