Cap for male and female screw joints

Abstract

A cap for sterilizing a needleless connector is described herein. The cap includes a housing having a cavity and an insert disposed therein. The insert includes one or more cantilever tips disposed on an end wall of the insert. The one or more cantilever tips are configured to bend upon insertion of the needleless connector. An outer sidewall of the one or more cantilever tips includes one or more ledges extending essentially perpendicular to the one or more cantilever tips, the one or more ledges configured to press against the sidewall of the housing to prevent further bending of the one or more cantilever tips upon advancement of the needleless connector.

Description

Technical Field

[0001] The present disclosure relates generally to an apparatus for disinfecting and sterilizing an access port having, for example, male and female luer fittings, and more particularly to a disinfection and sterilization apparatus capable of accommodating multiple types of connectors. Generally, exemplary embodiments of the present disclosure relate to the field of threaded fittings including medical caps and medical disinfection caps, and more particularly to caps and / or disinfection caps for use with fluid luer connectors.

Background Art

[0002] Background Vascular access devices (VADs) are commonly used therapeutic devices and include intravenous (IV) catheters. VADs are generally classified into two categories: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system from access hubs or ports / valves when connecting to an assistive artificial heart for supplying liquids and pharmaceuticals. Each access hub (or port / valve or connection) is associated with some risk of transmitting catheter-related bloodstream infections (CRBSIs), which can be costly and potentially fatal.

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

[0004] Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and the Infusion Nursing Standards of Practice (INS) guidelines.

Summary of the Invention

Problems to be Solved by the Invention

[0005] In advanced markets, when using an IV catheter, a needleless connector is generally used to close the system, and then access is made to administer drugs or other necessary fluids to the patient through the catheter. The INS implementation standards recommend the use of needleless connectors and state that "before each access, it should be consistently and thoroughly disinfected using alcohol, povidone-iodine, or a combination of chlorhexidine gluconate / alcohol." The disinfection of needleless connectors ultimately aims to reduce bacteria that may inhabit the surface and cause various catheter-related complications including CRBSI. Nurses usually complete this disinfection process through a so-called "hub scrubbing" operation using 70% isopropyl alcohol (IPA) pads. However, compliance with this practice is generally very low. In addition to the lack of compliance with "hub scrubbing," it has also been pointed out through interviews with practitioners that there are often variations in the scrubbing time, drying time, and the number of times the needleless connector is scrubbed.

[0006] Through a series of procedures related to the infection of microorganisms that may cause CRBSI, there are many risks of contact or contamination. Contamination can occur during drug mixing, cannula attachment, and insertion into the access hub. Since the procedures for connecting to a VAD are very common and simple, the risks related to the invasion of the patient's vascular system have often been overlooked. Currently, the risks to the hospital and the patient are a substantial role of the diligence of the practitioner performing the connection, and this diligence is mostly uncontrollable.

[0007] Currently, the capless male connector, capless female connector, intravenous (IV), and blood dialysis line caps use different designs and are thus limited to the types of connectors to which the caps can be attached. Currently, there is a male disinfection cap device for disinfecting an ISO 594-2 type female threaded fluid luer connector, and there is also a female disinfection cap device for disinfecting an ISO 594-2 type male threaded fluid luer connector. However, there is no single universal disinfection cap device with functions compatible with both male and female threaded connectors. Therefore, the prior disinfection caps were designed to fit only one type of connector and were specific to one particular size and / or shape of the connector. Therefore, there is a need for a disinfection device that can accommodate multiple types of connectors, including both male and female connectors, to rationalize the disinfection process.

[0008] There is also a need to provide a disinfection cap that has a proper mechanical fit and alignment for mating with the connector, notifies the user when a complete engagement has been achieved, and thus distributes a complete amount of disinfectant.

Means for Solving the Problems

[0009] Summary A first aspect of the present disclosure relates to a substantially cylinder-shaped housing, a substantially cylinder-shaped insert, and a cap having one or more cantilever tips. The substantially cylinder-shaped housing has a terminal wall, an open proximal end portion, and a side wall, the side wall having an inner surface and an outer surface, and the inner surface, the terminal wall, and the open proximal end portion defining a cavity of the housing. The substantially cylinder-shaped insert has an open proximal end portion and a closed distal end portion, the closed distal end portion defining a terminal wall having an inner surface and an outer surface, the insert being removably disposed within the cavity of the housing, and an outer surface of the terminal wall of the insert abutting the terminal wall of the housing. The one or more cantilever tips project from an inner surface of the terminal wall of the insert, the one or more cantilever tips having side walls, the one or more cantilever tips being configured to bend to facilitate an interference fit between the insert and a mating feature of the needleless connector. The cavity of the insert is defined by an inner surface of the insert, side walls of the one or more cantilever tips, and an open proximal end portion of the insert. One or more shelves extend perpendicular to the one or more cantilever tips, the one or more shelves being configured to be pressed against the side wall of the housing to resist further bending of the one or more cantilever tips upon advancement of the needleless connector. The cap further includes 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 projects from the terminal wall of the housing, and the centering feature of the housing is configured to interlock with a corresponding centering feature of the insert upon insertion of the insert into the cavity of the housing.

[0011] In one or more embodiments, the centering feature of the insert extends a portion of the outer surface of the insert into the terminal wall of the insert, and the centering feature is a ring-shaped channel.

[0012] In one or more embodiments, one or more cantilever tips are separated by a gap. In one or more embodiments, one or more cantilever tips are an integral cylindrical body.

[0013] In one or more embodiments, one or more shelves are disposed at least partially along a length portion of one or more cantilever tips.

[0014] In one or more embodiments, one or more shelves include support ribs disposed under one or more shelves and attached to one or more cantilever tips, the support ribs configured to impart rigidity to one or more shelves.

[0015] In one or more embodiments, the disinfectant is absorbed within 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 an end wall of the housing and an end 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 bactericide.

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

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

[0020] In one or more embodiments, the end wall of the insert has a diameter R2, one or more cantilever tips have a diameter R1, and the diameter R2 of the end wall is larger than the diameter R1 of one or more cantilever tips.

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

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

[0023] In one or more embodiments, the inner sidewall of one or more cantilever tips includes at least one internal thread configured to fit with the threaded portion of the needleless connector.

[0024] In one or more embodiments, at least one internal thread is configured to fit with the male needleless connector. In one or more embodiments, at least one external thread is configured to fit with the female needleless connector.

Brief Description of the Drawings

[0025]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12A

Figure 12B

[0026] Detailed Description Embodiments of the present disclosure relate to a sterile universal cap for connection and disinfection to a medical connector or needleless connector including a male connector and a female connector. The male and female connectors can be male and female Luer connectors. The cap may further include an absorbent material, a bactericide or antibacterial agent, and a peelable seal and / or septum. The cap provides a mechanical barrier to the connector and contains an antibacterial agent for sterilization. The cap of the present disclosure enables the operator to streamline the disinfection process.

[0027] Regarding the terms used in the present disclosure, the following definitions are provided.

[0028] As used herein, the use of "a", "an", and "the" includes singular and plural forms.

[0029] 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.

[0030] As used herein, the term "luer connector" means a connection collar that is a standard way of attaching syringes, catheters, hub needles, IV tubes, etc. to each other. A luer connector consists of male and female interlocking tubes that are slightly tapered to allow for better retention, even with simple pressure / twist fitting. Optionally, the luer connector can further include an external threaded portion to enhance safety. The male end of the luer connector is generally associated with a flush syringe and can be connected in an interlocking manner to the female end located on a vascular access device (VAD). The luer connector includes a distal end, a proximal end, an outer wall of irregular shape, and a contoured central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The luer connector also has a distal end channel for releasably attaching the luer connector to the hub of the VAD and a proximal end channel for releasably attaching the luer connector to the barrel of the syringe.

[0031] As will be readily understood by those skilled in the relevant art, descriptive terms such as "lock", "tip", "hub", "threaded portion", "sponge", "point", "projection", "tab", "wall", "top", "side", "bottom", etc. are used throughout this specification for ease of understanding, but are not intended to limit any of the components that can be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0032] The embodiments illustrated herein are provided to assist in a comprehensive understanding of the exemplary embodiments of the present disclosure. Accordingly, 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. Also, descriptions of well-known functions and structures are omitted for clarity and brevity.

[0033] Exemplary embodiments of the present disclosure provide a cap that includes features that enable it to be used with both male and female screw joints in a single cap or device, thereby reducing by approximately half the number of device types and logistics currently required in a hospital environment to connect, cap, and / or sterilize male and female fluid luer connectors.

[0034] In an exemplary implementation of an embodiment of the present disclosure, a cap, connector cap, or sterilization cap includes an integrated screw portion, or multiple screw portions, and other feature portions in any and all combinations that enable interfacing with both male and female screw joints.

[0035] According to a further exemplary implementation of an embodiment of the present disclosure, the configuration of the structural elements that make up the cap includes one or more cantilever tips disposed within the internal cavity of the cap, the cantilever tips including an internal thread that connects to the screw portion of the female medical connector and an external thread that connects to the screw portion of the male medical connector, facilitating securing the cap to the female or male joint, respectively.

[0036] According to yet another exemplary embodiment of an embodiment of the present disclosure, both the male and female screws match each other on the inner and outer surfaces of the threaded protrusion.

[0037] According to yet another exemplary embodiment of an embodiment of the present disclosure, the cantilever tip may be in the form of a protrusion, and the protrusion may be a split screw type that can bend or flex to allow for better compliance with an interference fit with the joint.

[0038] According to yet another exemplary embodiment of an embodiment of the present disclosure, one or more shelf portions may be disposed on the cantilever tip to limit the angle of deflection of the cantilever tip and enhance the safety of engagement when the sterilization cap is connected to the male or female connector.

[0039] According to yet another exemplary embodiment of the present disclosure, the female thread is sized to engage a standard ISO594-2 type male fitting, has a thread pattern, and / or the male thread is sized to engage a standard ISO594-2 type female fitting and has a thread pattern. An example of an ISO594-2 type fitting is a Q-style fitting.

[0040] In one or more embodiments, the female 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 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, and the like.

[0041] In one or more embodiments, the male connector may be a venous tube end, a stopcock, or a male lock luer.

[0042] Before describing some exemplary embodiments of the present disclosure, it will be understood that the present disclosure is not limited to the structural details or process steps shown in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0043] Referring now to the drawings, like reference numerals designate the same or corresponding parts throughout the several views, and embodiments of the present disclosure are described as follows.

[0044] FIG. 1 is an exploded perspective view of the disinfection cap 100. The disinfection cap 100 includes an insert 150 removably disposed within an outer housing 120. In one or more embodiments, an absorbent material 192 is disposed within the insert 150. The absorbent material 192 includes a disinfectant or gel.

[0045] As shown in FIGS. 2A-2C, the housing 120 is substantially cylindrical in shape and includes an essentially cylindrical side wall 122, an end wall 124, and an open proximal end 126. The side wall 122 includes an inner surface 128 and an outer surface 130. A cavity 132 is defined by the end wall 124, the open proximal end 126, and the inner surface 128. In one or more embodiments, the outer surface 130 of the side wall 122 includes a plurality of grip 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.

[0046] In one or more embodiments, the peelable seal 190 is disposed on the engagement surface 136 of the open proximal end 126 of the housing 120 and is configured to prevent a bactericide or antibacterial agent from exiting the cavity 132. With the absorbent material 192 fully inserted into the cavity 132 of the housing 120, the peelable seal 190 may be fixed 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 enclosure for the cap 100, provides leak prevention and a protective enclosure, protects the contents of the absorbent material 192 contained within the cavity 132, and / or maintains a sealed and sterilized environment. The peelable seal 190 provides a sufficient seal over a range of temperature, pressure, and humidity levels.

[0047] In yet another exemplary embodiment, a sterilizing member or members, such as a sponge soaked in isopropyl alcohol (IPA) and / or an absorbent material 192 in the form of a sponge, are disposed within the cavity 132. In one or more embodiments, the absorbent material 192 can also be formed together as a single cleaning member or separate cleaning members provided within the cavity 132.

[0048] In one or more embodiments, as best shown in FIGS. 2B and 2C, a centering feature 138 is disposed within the cavity 132 and extends from the end wall 124. As shown, the centering feature 138 is in the form of a protruding ring centered on the end wall 124 of the housing 120. In one or more embodiments, the protruding ring of the centering feature 138 has a chamfered wall. In one or more embodiments, the protruding ring of the centering feature 138 has a rounded wall. The centering feature 138 of the housing 120 is configured to interact with a corresponding centering feature (not shown) of the insert 150 upon advancement or insertion of the insert 150 into the cavity 132 of the housing 120, as discussed in further detail below.

[0049] As shown in FIGS. 3 and 8, the insert 150 is movable forward or insertable into the cavity 132 of the housing 120 along the longitudinal direction. When fully advanced, the insert 150 abuts against the end wall 124 of the housing 120. In one or more embodiments, the absorbent material 192 is disposed within the cavity 132 of the housing 120. In one or more embodiments, the advancement of the insert 150 causes longitudinal compression of the absorbent material 192, thereby dispensing the disinfectant absorbed by the absorbent material 192. In one or more embodiments, the advancement of the needleless connector along the longitudinal direction contacts the insert 150, subsequently causing longitudinal compression of the absorbent material 192, thereby discharging the disinfectant. In one or more embodiments, the diameter of the cavity 132 of the housing 120 is larger than the diameter of the insert 150, such that the dispensed disinfectant can leak out between the inner surface 128 of the side wall 122 of the housing 120 and the insert 150.

[0050] As shown in FIGS. 4 - 7, the insert 150 has a substantially cylindrical body having an open proximal end portion 152 and a closed distal end portion 154 having a distal wall 156. The distal wall 156 has a substantially cylindrical shape having an inner surface 158 and an outer surface 160. From the inner surface 158 of the distal wall 156, one or more cantilever tips 162 project. The one or more cantilever tips 162 are separated by gaps 184 therebetween. The one or more cantilever tips 162 have an overall cylindrical shape. The one or more cantilever tips 162 have an overall discontinuous cylindrical shape caused by the gaps 184 that separate the one or more cantilever tips 162. In one or more embodiments, the one or more cantilever tips can be configured to bend to facilitate an interference fit between the insert 150 and a mating feature of a male - or female - needleless connector. In one or more embodiments, the insert 150 can extend essentially from the inner surface 158 of the distal wall 156 toward the open proximal end portion 126 of the housing 120. In one or more embodiments, the one or more cantilever tips 162 extend essentially parallel to the sidewall 122 of the housing 120.

[0051] In an alternative embodiment, the one or more cantilever tips 162 are of an integral cylindrical body and the separated portions 184 of the integral cylindrical body are arranged without gaps. In one or more embodiments, the insert has an integral body without gaps 184 with any number of the same and / or different tips (in any dimensional characteristic such as length, width, thickness, or shape) so long as it is configured to engage a female connector with respect to its inner surface and a male connector with respect to its outer surface.

[0052] In one or more embodiments, the inner sidewall 166 of one or more cantilever tips 162 includes at least one internal thread 170 configured to mate with the threaded portion of a female - needleless connector. In one or more embodiments, the outer sidewall 168 of one or more cantilever tips 162 includes at least one external thread 172 configured to mate with the threaded portion of a male - needleless connector. In one or more embodiments, the at least one internal thread 170 and the at least one external thread 172 are in a helical pattern.

[0053] As shown in FIG. 5, the at least one internal thread 170 can be included on the inner sidewall 166 of one or more cantilever tips 162, and the at least one internal thread 170 is sufficient to interact with the mating feature of the needleless connector. In one or more embodiments, the at least one internal thread 170 has a size and pitch to engage a threaded segment of a needleless connector, such as a female Luer connector. Such connectors are commonly and ordinarily used as catheters and other fluid - tight protective connectors in medical applications. In one or more embodiments, the cap 100 provides a protective cover for the female Luer connector when it engages the connector when the threaded portion from the female Luer connector engages the at least one internal thread 170 to form a releasable connection.

[0054] In yet a further exemplary embodiment, the contour of the at least one internal thread 170 and / or the inner sidewall 166 can be essentially parallel or coincident with the contour of the at least one external thread 172 and / or the outer sidewall 168, respectively.

[0055] As shown in FIGS. 5 and 6, in one or more embodiments, one or more cantilever tips 162 include a distal portion 180 and a proximal portion 182, and the distal portion 180 has a wall thickness greater than the wall thickness of 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 side wall 166 and the outer side wall 168 of the one or more cantilever tips 162. In one or more embodiments, the outer side wall is tapered inwardly from the distal portion 180 toward the proximal portion 182.

[0056] The cavity 164 of the insert 150 is defined by the distal wall 156, the inner side wall 166 of the one or more cantilever tips 162, and the open proximal end 152. The cavity 164 is configured to receive a needleless connector, such as a female luer connector, by way of example. In one or more embodiments, the inner side wall 166 of the cantilever tip 162 includes at least one internal thread 170 configured to mate with the threaded portion of a female needleless connector. In one or more embodiments, the at least one internal thread 170 extends at least partially from the open proximal end 152 along a length portion of the one or more cantilever tips 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.

[0057] As best shown in FIG. 6, the end wall 156 has a diameter R2, and the end portion 180 of one or more cantilever tips 162 has a diameter R1. The diameter R2 of the end wall 156 is larger than the diameter R1 of the end portion 180 of one or more cantilever tips 162, and one or more cantilever tips 162 extend from the inner surface 158 of the end wall 156 rather than from the edge of the end wall 156. This configuration allows a collar of the connector without a needle to be inserted into a gap 184 formed between the outer side wall 168 of one or more cantilever tips 162 and the inner surface 128 of the side wall 122 of the housing 120, as shown in FIGS. 7A and 7B. In one or more embodiments, the insert 150 is configured to engage with a female connector with respect to its inner side wall 166 and with a male connector with respect to its outer side wall 168. Similarly, at least one internal thread 170 is configured to engage with a threaded portion of a female connector without a needle, and at least one external thread 172 is configured to engage with a threaded portion of a male connector without a needle.

[0058] Referring to FIGS. 7-10, the centering feature 174 of the insert 150 is disposed on the outer surface 160 of the end wall 156 of the insert 150, and the centering feature 138 extends partially from the outer surface 160 into the end wall 156. As shown, the centering feature 174 is in the form of a ring-shaped channel centered on the end wall 156 of the insert 150. In one or more embodiments, the channel of the centering feature 174 has chamfered walls. In one or more embodiments, the channel of the centering feature 174 has rounded walls. The centering feature 174 of the insert 150 is configured to interact with a corresponding centering feature 138 of the housing 120 when the insert 150 is advanced or inserted longitudinally into the cavity 132 of the housing 120, and the centering feature of the housing 120 is disposed on the inner surface 128 in the case of the end wall 124 of the housing 120.

[0059] As shown in FIGS. 8 to 10, 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, and the length of the insert is less than the length of the cavity 132 of the housing 120 so that the insert 150 does not protrude beyond the cavity 132 of the housing 120. When the absorbent material 192 is compressed longitudinally toward the end wall 124 of the housing 120 upon connection to a female or male Luer connector, the connector can contact a bactericide or antibacterial agent to sterilize the female or male Luer connector.

[0060] Referring to FIGS. 3 to 11, the insert 150 further includes one or more shelf portions 176. The one or more shelf portions 176 extend essentially perpendicular to one or more cantilever tips 162 of the insert 150. The one or more shelf portions 176 are disposed and protrude at least partially away from the end wall 156 along the one or more cantilever tips 162.

[0061] One or more ledges 176 increase the mechanical fit of the connector without a needle to the cap 100. When the connector without a needle is mechanically fixed to the insert 150, one or more cantilever tips 162 are pushed radially outward. As a result, one or more ledges 176 are pushed against the side wall 122 of the housing 120 to resist further radial movement or deflection of one or more cantilever tips 162. The resistance from one or more ledges 176 increases the torque requirement and separation force for removing the connector from the cap, improving the fixation of the cap 100 on the connector. The resistance is noticeable to the user, thereby allowing the user to notice that the connector without a needle has been fully advanced to the final position where the disinfectant is completely dispersed from the absorbent material 192 due to the compression of the absorbent material 192. Further, one or more ledges 176 are evenly displaced radially outward toward the side wall 122 of the housing 120 to improve the alignment of the cap 100 when fixed to the medical connector. Further, one or more ledges 176 can resist further engagement of the mechanical connection between the two components. One or more ledges 176 prevent a further screw connection between the cap 100 and the connector without a needle. One or more ledges 176 engaged with the medical connector will notify the user that a complete engagement between the threaded insert and the threaded portion of the connector without a needle has been ensured. In one or more embodiments, one or more ledges 176 engaged with the connector without a needle function as a physical stop to prevent further advancement into the cavity of the connector without a needle, thereby notifying the user that a complete engagement between the threaded insert and the threaded portion of the connector without a needle has been ensured. One or more ledges 176 limit the angle of deflection of one or more cantilever tips 144, enhancing the safety of the engagement when the cap 100 is connected to the connector without a needle. The placement distance of one or more ledges 176 on one or more cantilever tips 162 can be configured to limit the desired angle of deflection.

[0062] In one or more embodiments, one or more shelf portions 176 are transverse to one or more cantilever tips 162. The length portion of one or more shelf portions 176 extends across the arcuate length portion of one or more cantilever tips 162 of insert 150.

[0063] As shown in FIG. 7, in one or more embodiments, one or more shelf portions 176 include support ribs 178 disposed below one or more shelf portions 176 and attached onto one or more cantilever tips 162 of insert 150. Support ribs 178 are configured to impart rigidity to one or more shelf portions 176. In one or more embodiments, support ribs 178 are integrated with one or more shelf portions 176. In a preferred embodiment, one or more shelf portions 176 are supported by one or more support ribs 178.

[0064] One or more cantilever tips 162 and / or insert 150 may have various shapes including, but not limited to, trapezoidal, inverted trapezoidal, convex inner surface (e.g., parabolic), concave inner surface, or straight contour (i.e., cylindrical or semi-conical). In one or more embodiments, one or more cantilever tips are tapered inwardly from the end wall 156 of the insert towards the open proximal end. In one embodiment, insert 150 is integrally formed with housing 120 and is disposed within cavity 132 of housing 120.

[0065] Figures 12A and 12B show how the insert 150 engages with the needleless connector 194. For purposes of illustration, the housing 120 is not shown, but it should be understood that the needleless connector 194 will ultimately be covered by the housing 120. One or more shelves 176 disposed on one or more cantilever tips 162 are configured to limit how far or how deeply the needleless connector 194 can be screwed or inserted into the insert. The needleless connector 194 is fixedly screwable into the insert 150, and one or more shelves 176 disposed on one or more cantilever tips 162 control or limit the depth to which the needleless connector 194 can be screwed into the insert 150 because at the desired insertion, the one or more shelves 176 mechanically abut the needleless connector 194.

[0066] In one or more embodiments, the absorbent material 192 is under radial compression by the inner sidewall 166 of the insert 150, holding the absorbent material 192 within the cavity 164 of the insert 150.

[0067] When used with a needleless or luer connector, the cap 100 can achieve sterilization by incorporating a bactericide or antibacterial agent within the cavity 132 of the cap 100. The disinfectant or antibacterial agent can be included directly in the cavity 132, or the disinfectant or antibacterial agent can be absorbed within a sponge or foamed material that fills a chamber of the cap 100, such as the absorbent material 192. The cap 100 is configured to be compatible when interacting with various disinfectants.

[0068] The housing 120 and the insert 150 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 housing 120 comprises a polypropylene or polyethylene material.

[0069] Referring, in one or more embodiments, the peelable seal 190 is disposed on the engagement surface of the open proximal end portion 126 of the housing 120 to prevent the bactericide or antibacterial agent from exiting the cavity 132. With the absorbent material 192 properly inserted within the cavity 132 of the cap 100, the peelable seal 190 may be fixed to the engagement surface of the open proximal end portion 126 of the housing 120. The peelable seal 190 minimizes the intrusion of potential particulate hazards and also provides a substantially impermeable package for the cap 100, provides leak prevention and protective packaging, protects the contents of the absorbent material contained within the cavity 132, and / or maintains a sealed and sterilized environment. The peelable seal 190 provides a sufficient seal over a range of temperature, pressure, and humidity levels.

[0070] In one or more embodiments, the peelable seal 190 comprises a peel-back top of aluminum or multilayer polymer film. In a specific embodiment, the peelable seal 190 is heat-sealed or induction-sealed to the end face of the locking lid or the open end of the cap. In one or more embodiments, the peelable seal 190 comprises a moisture barrier.

[0071] In one or more embodiments, the peelable seal 190 includes a peel-back top of aluminum or multilayer polymer film. In a specific embodiment, 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 comprises a moisture barrier. In one or more embodiments, the peelable seal 190 is thin enough to be pierced by a needleless connector such that the needleless connector can be inserted or advanced into the housing 120 without first removing the peelable seal 190.

[0072] In one or more embodiments, the absorbent material 192 is a non-woven material, a foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment, 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.

[0073] In one or more embodiments, the insert 150 and the housing 120 can be adhesively bonded together by ultrasonic welding or a solvent-resistant biocompatible adhesive. In one or more embodiments, the insert 150 and the housing 120 can also be interlocked by an interference fit or a snap fit.

[0074] When the cap 100 is used for a luer connector, sterilization can be achieved by incorporating a bactericide or an antibacterial agent into the cavity 132 of the housing 120 and / or the cavity 164 of the insert 150. The bactericide or antibacterial agent can be directly included in the cavity 132 of the housing 120 and / or the cavity 164 of the insert 150, or the bactericide or antibacterial agent can be absorbed by 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 antibacterial agent may include an alcohol or a variant of chlorhexidine. In one or more embodiments, the bactericide or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, 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 bactericide or antibacterial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the bactericide or antibacterial agent is a fluid or a gel.

[0075] According to an exemplary embodiment of the present disclosure as shown in FIGS. 12A and 12B, the housing 120 can receive the tip or hub of a needleless connector, for example, after the peelable seal 190 has been removed or punctured. By way of example, a female needleless 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, the tip is advanced into the cavity 164 of the insert 150, and the collar is received within the cavity 132 of the housing 120. When the insert 150 is disposed within the cavity 132 of the housing 120, the collar is disposed between one or more cantilever tips 162 of the insert 150 and the sidewall 122 of the housing. By way of example, a male luer connector or stopcock is received within the cavity 132 of the housing. When the insert 150 is disposed within the cavity 132, the male luer connector is disposed between one or more cantilever tips 162 of the insert 150 and the sidewall 122 of the housing. At least one internal thread 170 and / or at least one external thread 172 is configured to mate with and secure to the threaded portion of the female or male luer connector. Such a threaded portion of the male or female luer connector may be one or more protrusions, lugs, and / or threaded portions in one or more embodiments.

[0076] As shown in FIG. 12B, when the needleless connector 194 is fully advanced into the cap 100, one or more ledges 176 abut against the collar 196 of the needleless connector 194, thereby preventing further advancement of the needleless connector 194 into the cap 100. The housing (not shown) of the cap 100 surrounds the collar 196 when the needleless connector 194 is fully advanced. During operation, advancement of the needleless connector into the cavity 164 of the insert 150 causes compression of the absorbent material 192, whereby the disinfectant is released due to the compression of the absorbent material 192. In one or more embodiments, the absorbent material 192 is disposed within the cavity 132 of the housing, and the absorbent material 192 is disposed between the end wall 124 of the housing and the insert 150, whereby advancement of the needleless connector into the cavity 164 of the insert 150 causes the insert 150 to compress the absorbent material 192 against the end 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, whereby advancement of the needleless connector causes compression of the absorbent material 192 against the end wall 156 of the insert 150.

[0077] Although the present disclosure has been shown and described with reference to its particular exemplary embodiments, it will be understood by those skilled in the art that various changes in form and detail may 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 use-specific substance and can be made of any suitable material. Also, the inner and / or outer housing of the cap can be single-shot molded or manufactured by other suitable processes. Further, any of the features or elements of any exemplary implementation of the embodiments of the present disclosure as described above and shown in the drawings can be individually or in any combination(s) that will be readily understood by those skilled in the art without departing from the spirit and scope of the embodiments of the present disclosure.

[0078] Furthermore, the included drawings further illustrate non-limiting examples of the implementation of certain exemplary embodiments of the present disclosure and assist in the description of the related art. Any specific or relative dimensions or measurements provided in the drawings other than those described above are exemplary and not intended to be limiting.

[0079] References throughout this specification to "one embodiment," "certain embodiments," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of the phrases "in one or more embodiments," "in certain embodiments," "in one embodiment," or "in an embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0080] Although the disclosure of this specification provides descriptions with reference to specific embodiments, it should be understood that these embodiments merely exemplify the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the methods and apparatuses of the present disclosure without departing from the spirit and scope of the present disclosure. Accordingly, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A cap comprising: A substantially cylindrical housing having a terminal wall, an open proximal end portion, and a side wall, the side wall having an inner surface and an outer surface, the inner surface, the terminal wall, and the open proximal end portion defining a cavity of the housing; A substantially cylindrical insert having an open proximal end portion and a closed distal end portion, the closed distal end portion defining a terminal 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 terminal wall of the insert abutting the terminal wall of the housing; One or more cantilever tips protruding from the inner surface of the insert, the one or more cantilever tips having side walls defining a length portion, the one or more cantilever tips being configured to bend to facilitate an interference fit between the insert and a mating feature of a needleless connector; and A cavity of the insert defined by the inner surface of the insert, the side walls of the one or more cantilever tips, and the open proximal end portion of the insert; Absorbent material And further comprising: One or more shelves extending perpendicular to and essentially at a right angle to the one or more cantilever tips, the one or more shelves being configured to be pressed against the side wall of the housing to resist further bending of the one or more cantilever tips during advancement of the needleless connector.

2. The cap according to claim 1, further comprising a centering feature of the housing disposed within the cavity of the housing.

3. The cap according to claim 2, wherein the centering feature protrudes from the terminal wall of the housing and is configured to interlock with a corresponding centering feature of the insert when the insert is inserted into the cavity of the housing.

4. The cap according to claim 2, further comprising a centering feature disposed on the outer surface of the terminal wall of the insert, the centering feature of the insert partially extending the outer surface of the insert into the terminal wall of the insert, the centering feature being a ring-shaped channel.

5. The cap according to claim 1, wherein the one or more cantilever tips are separated by a gap.

6. The cap according to claim 1, wherein the one or more cantilever tips are an integral cylindrical body.

7. The cap according to claim 1, wherein the disinfectant is absorbed within the absorbent material.

8. The cap according to claim 7, wherein the absorbent material is disposed within the cavity of the housing, and the absorbent material is disposed between the end wall of the housing and the outer surface of the end wall of the insert.

9. The cap according to claim 8, wherein the advancement of the insert into the cavity of the housing causes compression of the absorbent material, thereby releasing the disinfectant.

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

11. The cap according to claim 1, wherein the advancement of the needleless connector into the cavity of the insert causes compression of the absorbent material, thereby releasing the disinfectant.

12. The cap according to claim 1, wherein the diameter of the cavity of the housing is larger than the diameter of the insert.

13. The cap according to claim 12, wherein the disinfectant is absorbed within the absorbent material, and the disinfectant leaks out from between the inner surface of the side wall of the housing and the insert.

14. The cap according to claim 1, wherein the end wall of the insert has a diameter R2, the one or more cantilever tips have a diameter R1, and the diameter R2 of the end wall is larger than the diameter R1 of the one or more cantilever tips.

15. The cap according to claim 14, wherein the collar of the needleless connector is inserted into a gap formed between the one or more cantilever tips and the side wall of the housing.

16. The cap according to claim 1, wherein the insert is configured to engage with a female connector with respect to its inner side wall and engage with a male connector with respect to its outer side wall.

17. The cap according to claim 16, wherein the inner side wall of the one or more cantilever tips includes at least one internal thread configured to fit with a threaded portion of the needleless connector.

18. The cap according to claim 1, wherein the one or more shelf portions are at least partially disposed in the length portion of the one or more cantilever tips.

19. The cap according to claim 1, wherein the one or more shelf portions include support ribs positioned under the one or more shelf portions and attached to the one or more cantilever tips, and the support ribs are configured to impart rigidity to the one or more shelf portions.

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