Universal Cap with Pressure Seal

Abstract

A cap for connecting to a medical connector includes a housing, a protrusion, a disinfecting sponge, and a pressure seal. The protrusion includes internal threads on an inner surface, the internal threads being sufficient to interlock with a mating feature of a female needleless connector. The inner surface of the protrusion defines a second cavity. The protrusion includes external threads on an outer surface, the external threads being sufficient to interlock with a mating feature of a male needleless connector. The disinfecting sponge is disposed over the second cavity. The pressure seal is attached to the housing and positioned adjacent to a surface of the disinfecting sponge. The pressure seal can include a flexible insert attached to the inner surface of the upper wall of the housing. The pressure seal can include a combination of an elongated member and an insert that slidably engages with the elongated member.

Description

[Technical Field]

[0001] The present disclosure relates generally to devices for disinfecting and sterilizing access ports, for example, with male and female Luer fittings, and more particularly to a disinfection and sterilization device that can accommodate multiple types of connectors. Generally, the present embodiments 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 technology]

[0002] Vascular access devices (VADs) are commonly used medical devices and include intravenous (IV) catheters. There are two general classifications of VADs: peripheral catheters and central venous catheters. Bacteria and other microorganisms can enter a patient's vascular system through the access hub or port / valve when connected to a VAD to deliver fluids or medications. Each access hub (or port / valve / connection) is associated with some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0003] Codes of practice, including disinfection and cleaning procedures, have been developed to reduce cases of CRBSI and ensure VADs are used and maintained correctly.

[0004] Antiseptic caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines, and there are early indications that caps will also be incorporated into the 2016 Infusion Nursing Standards (INS) guidelines.

[0005] In developed markets, IV catheters typically use a needleless connector to close the system and then access the catheter to administer medications and other necessary fluids to the patient. The INS Standards of Practice recommend the use of needleless connectors and state that they should be consistently and thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access. Disinfection of needleless connectors ultimately aims to help reduce bacteria that may inhabit surfaces and cause various catheter-related complications, including CRBSI. Nurses typically accomplish this disinfection task by performing a process known as "hub scrubbing" using a 70% isopropyl alcohol (IPA) pad. However, adherence to this practice is typically very low. In addition to lack of adherence to "hub scrubbing," clinician interviews also noted frequent variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed.

[0006] There are numerous risks of contact or contamination throughout the procedure related to the transmission of microorganisms that can cause CRBSI. Contamination can occur during drug mixing, cannulation, and insertion into the access hub. Because the procedure for connecting a VAD is so common and simple, the risks associated with entering the patient's vascular system are often overlooked. Currently, the risk to the hospital and patient is substantially the result of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.

[0007] Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV) and hemodialysis lines use different designs, limiting the type of connector to which they can be attached. Currently, there are male disinfection cap devices for disinfecting ISO 594-2 type female threaded fluid luer connectors and female disinfection cap devices for disinfecting ISO 594-2 type male threaded fluid luer connectors. However, there is no single, universal disinfection cap device capable of being compatible with either male or female threaded connectors. Therefore, conventional disinfection caps are designed to fit only one type of connector and are specific to a particular size and / or connector shape. Thus, there is a need for a disinfection device that can accommodate multiple types of connectors, including both male and female connectors, to streamline the disinfection process.

[0008] In addition to providing a disinfectant device, disinfectant intrusion is a consideration because it can compromise patient safety. Disinfectant intrusion must be mitigated to a non-toxic level in accordance with toxicological standards. While needleless connectors have septa within them to form a closed system, disinfectant caps used with medical connectors, such as male connectors on the ends of IV tubing and open female Luer ports on catheters and stopcocks, must minimize the intrusion of disinfectants, such as isopropyl alcohol or chlorhexidine, into the central lumen of the connector. Summary of the Invention [Means for solving the problem]

[0009] Aspects of the present disclosure relate to a cap for use with a medical connector.

[0010] In one aspect, the cap comprises a housing having a top wall, an essentially cylindrical sidewall forming a first cavity, an open bottom formed by the cylindrical sidewall having an opening to the first cavity within the housing for receiving a hub of a medical connector, a protrusion extending from the housing and positioned within the first cavity, the protrusion having an inner and outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to interlock with a threaded fitting of a female medical connector and external threads on the outer surface of the protrusion, the external threads sufficient to interlock with a threaded fitting of a male medical connector, a disinfecting sponge configured within the second cavity, and a pressure seal attached to the housing and positioned adjacent to a surface of the disinfecting sponge.

[0011] In one or more embodiments, upon engagement of the cap with the medical connector, the disinfecting sponge contacts the lumen edge of the medical connector and a pressure seal blocks the lumen of the medical connector, thereby inhibiting ingress of disinfectant into the lumen.

[0012] In one or more embodiments, the lumen of the medical connector is open to the cap and the pressure seal penetrates the lumen and inhibits the entry of antiseptic into the lumen.

[0013] In one or more embodiments, when the medical connector includes a septum within the lumen, the pressure seal is positioned to not create a fluid path through the septum.

[0014] In one or more embodiments, the antiseptic sponge comprises a slotted end, an essentially cylindrical sponge side wall defining a hollow and open end, and a sponge end wall.

[0015] In one or more embodiments, the slotted ends of the antiseptic sponge comprise slots that extend into opposing portions of the sponge sidewall.

[0016] In one or more embodiments, the slots extend along opposing portions of the sponge sidewall to the open end.

[0017] In one or more embodiments, the pressure seal is disposed in the hollow of the disinfecting sponge.

[0018] In one or more embodiments, in the uncompressed state, the pressure seal is disposed completely hollow.

[0019] In one or more embodiments, the sponge end wall is in direct contact with the inner surface of the top wall.

[0020] In one or more embodiments, the pressure seal comprises an elongated member and an insert, the elongated member extending from an inner surface of the top wall of the housing, the insert comprising a bottom wall and an essentially cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening, and the insert in slidable engagement with the elongated member.

[0021] In one or more embodiments, the inner surface of the upper edge slidably engages the elongate member.

[0022] In one or more embodiments, the elongate member comprises a shoulder, a ramp, and one or more sliders.

[0023] In one or more embodiments, the insert comprises a plurality of prongs defined by portions of the insert sidewall and a top edge separated by slits.

[0024] In one or more embodiments, a surface of the prong slidably engages the elongate member.

[0025] In one or more embodiments, the outer geometry of the insert sidewall comprises a tapered surface effective to complement the inner surface of the lumen of the medical connector.

[0026] In one or more embodiments, the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or combinations thereof.

[0027] In one or more embodiments, the pressure seal comprises a flexible insert attached to the inside surface of the top wall of the housing.

[0028] In one or more embodiments, the flexible insert comprises an elastomeric polymeric material.

[0029] In one or more embodiments, the flexible insert comprises a top wall, a bottom wall, and an essentially cylindrical, porous insert sidewall extending between the top and bottom walls.

[0030] In one or more embodiments, the top wall of the flexible insert further comprises an extension that engages the top lip of the protrusion.

[0031] In one or more embodiments, the flexible insert is breathable.

[0032] In another aspect, a cap comprising: a housing comprising a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity within the housing for receiving a hub of a medical connector; and a protrusion extending from the housing and located within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to mate with mating features of a medical connector comprising a female medical connector and external threads on the outer surface of the protrusion sufficient to mate with mating features of a male medical connector; an antiseptic sponge configured within a housing, the antiseptic sponge having a slotted end, an essentially cylindrical sponge sidewall defining a hollow and an open end, and a sponge end wall; and a pressure seal disposed within the hollow of the antiseptic sponge, the pressure seal comprising an elongated member extending from an inner surface of the housing's cylindrical wall, and an insert including a bottom wall and an essentially cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening, the insert slidably engaging the elongated member, and when engaged with the medical connector of the cap, the antiseptic sponge contacts an edge of the lumen of the medical connector, and the insert of the pressure seal blocks the lumen of the medical connector to inhibit infiltration of antiseptic into the lumen.

[0033] In one or more embodiments, the inner surface of the upper edge slidably engages the elongate member.

[0034] In one or more embodiments, the elongate member comprises a shoulder, a ramp, and one or more sliders.

[0035] In one or more embodiments, the insert sidewall comprises a plurality of prongs defined by portions of the insert sidewall and an upper edge separated by slits.

[0036] In one or more embodiments, a surface of the prong slidably engages the elongate member.

[0037] In one or more embodiments, the outer geometry of the insert sidewall comprises a tapered surface effective to complement the inner surface of the lumen of the medical connector.

[0038] In one or more embodiments, the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or combinations thereof.

[0039] Another aspect is a cap comprising a housing including a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity in the housing for receiving a hub of a medical connector; and a protrusion extending from the housing and positioned within the first cavity, the protrusion extending from the housing and positioned within the first cavity. the protrusion has an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to mate with mating features of a medical connector comprising a female medical connector, and external threads on the outer surface of the protrusion sufficient to mate with mating features of a male medical connector; and a disinfecting sponge configured within the second cavity, the disinfecting sponge comprising: a slotted end, an essentially cylindrical sponge side wall defining a hollow and an open end, and a sponge end wall; and a pressure seal disposed within the hollow of the disinfecting sponge, the pressure seal having a flexible insert attached to the inner surface of the cylindrical wall of the housing, wherein when the cap engages with the medical connector, the disinfecting sponge contacts the edge of the lumen of the medical connector and the pressure seal blocks the lumen of the medical connector to prevent disinfectant from entering the lumen.

[0040] In one or more embodiments, the flexible insert comprises an elastomeric polymeric material.

[0041] In one or more embodiments, the flexible insert comprises a top wall, a bottom wall, and an essentially cylindrical, porous insert sidewall extending between the top and bottom walls.

[0042] In one or more embodiments, the top wall of the flexible insert further comprises an extension that engages the top lip of the protrusion.

[0043] In one or more embodiments, the flexible insert is breathable.

[0044] In one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and a needleless connector.

[0045] In one or more embodiments, the disinfecting sponge comprises a disinfectant, an antibacterial agent, or a combination thereof.

[0046] 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 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.

[0047] In one or more embodiments, the antiseptic or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0048] In one or more embodiments, the protrusion is integrally formed with the housing.

[0049] In one or more embodiments, the protrusion is attached to the inner surface of the top wall of the housing.

[0050] In one or more embodiments, the protrusions are snap-fit ​​or glued to the inner surface of the top wall of the housing.

[0051] In one or more embodiments, the protrusion comprises an upper lip that engages an elongated ring extending from the inner surface of the upper wall of the housing.

[0052] A further aspect is a method of disinfecting a medical connector, comprising connecting the cap of any preceding embodiment to a medical connector by engaging the threads of the medical connector with the internal or external threads of the prong such that an end of the medical connector contacts the disinfecting sponge and a pressure seal inhibits ingress of disinfectant into the lumen of the medical connector.

[0053] One aspect provides a medical assembly comprising any of the cap embodiments disclosed herein.

[0054] In one or more embodiments, the medical connector is a female medical connector with a male threaded fitting selected from the group consisting of a needleless connector, a stopcock, a female luer connector, and a catheter connector.

[0055] In one or more embodiments, the medical connector is a male medical connector having a female threaded fitting selected from the group consisting of an intravenous tubing end and a male luer connector.

[0056] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify all key features or essential features of the claimed subject matter, nor is it intended to be used solely as an aid in determining the scope of the claimed subject matter.

[0057] Additional features and advantages of the present disclosure will be set forth in the description which follows, and in part will be obvious from the description, or may be learned by the practice of the present disclosure. The features and advantages of the present disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out in the claims. These and other features of the present disclosure will become more fully apparent from the following description and appended claims, or may be learned by the practice of the disclosure as set forth herein. [Brief explanation of the drawings]

[0058] [Figure 1] FIG. 1 illustrates a perspective side view of an exemplary medical assembly according to one embodiment. [Figure 2] FIG. 2 illustrates an exploded cross-sectional perspective top view of an exemplary cap according to one embodiment. [Figure 3] FIG. 3 illustrates a cross-sectional perspective top view of a housing according to an exemplary embodiment. [Figure 4] FIG. 4 illustrates a partial cross-sectional view of the elongate member of FIG. [Figure 5] FIG. 5 illustrates a cross-sectional view of an insert according to one embodiment. [Figure 6] FIG. 6 illustrates a perspective top view of the insert of FIG. [Figure 7] FIG. 7 illustrates a cross-sectional side view of an insert according to another embodiment. [Figure 8] FIG. 8 illustrates a perspective top view of a disinfecting sponge according to one embodiment. [Figure 9] FIG. 9 illustrates a cross-sectional perspective top view of the disinfecting sponge of FIG. [Figure 10] FIG. 10 illustrates a cross-sectional perspective top view of an antiseptic sponge according to another embodiment. [Figure 11] FIG. 11 illustrates a cross-sectional perspective top view of the cap according to FIG. [Figure 12] FIG. 12 illustrates an exploded cross-sectional perspective top view of an exemplary cap according to one embodiment. [Figure 13]FIG. 13 illustrates a perspective bottom view of a flexible insert according to one embodiment. [Figure 14] FIG. 14 illustrates a partial perspective top view of a flexible insert according to another embodiment. [Figure 15] FIG. 15 illustrates a partial perspective top view of a flexible insert according to another embodiment. [Figure 16] FIG. 16 illustrates a cross-sectional perspective top view of the cap according to FIG. [Figure 17] FIG. 17 illustrates an exemplary assembly showing the cap in cross-sectional side view and the female medical connector in partial side schematic view, according to one embodiment. [Figure 18] 18A shows an exemplary assembly showing the cap in cross-sectional side view and the male connector in partial schematic view, according to one embodiment, and FIG. 18B illustrates a cross-section of the male connector of FIGS. 18A and 21. FIG. [Figure 19] FIG. 19 illustrates an exemplary assembly showing the cap in a cross-sectional perspective top view and the female connector in a partial side perspective view, according to one embodiment. [Figure 20] FIG. 20 illustrates an exemplary assembly showing the cap in cross-sectional side view and the female medical connector in partial side view, according to one embodiment. [Figure 21] FIG. 21 illustrates an exemplary assembly showing the cap in cross-sectional side view and the male connector in partial schematic side view, according to one embodiment. [Figure 22] FIG. 22 illustrates an exemplary assembly showing the cap and female connector in a cross-sectional perspective top view, according to one embodiment. [Figure 23] FIG. 23 diagrammatically illustrates a cap in cross-sectional side view according to one embodiment. [Figure 24] FIG. 24 illustrates a perspective top view of a flexible insert according to one embodiment. [Figure 25] FIG. 25 illustrates a perspective cross-sectional view of the flexible insert according to FIG. 24 in combination with a protrusion according to one embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0059]

[0003] Embodiments of the present disclosure relate to a sterilized, universal cap having a pressure seal for connection to and disinfection of medical connectors, including male and female connectors. The male and female connectors can be male and female Luer connectors. An embodiment of the cap includes a housing, a protrusion, a disinfecting sponge, and a pressure seal. The cap includes a housing having a closed end and an open end. A sidewall of the housing has a length extending from the closed end to the open end and defining a chamber. In one or more embodiments, the open end includes a peripheral protrusion extending radially outward from an open surface defining an end face and an engagement surface. The protrusion has an inner surface having one or more threads for engaging the male threads of a female medical connector, e.g., a female Luer connector. The outer surface of the protrusion has one or more threads for engaging the female threads of a male medical connector, e.g., a male Luer connector. The disinfecting sponge is disposed within a cavity defined by the inner surface of the protrusion. The pressure seal is attached to the housing and disposed adjacent to the surface of the disinfecting sponge. In one embodiment, the pressure seal comprises a flexible insert attached to the inner surface of the top wall of the housing. In another embodiment, the pressure seal comprises a combination of an elongated member and an insert. The elongated member extends from the inner surface of the top wall of the housing and can be integrally formed with the housing, and the insert can be a slidable insert that slidably engages the elongated member.

[0060] The universal antiseptic caps with pressure seals disclosed herein are advantageous because they include a pressure seal that minimizes the intrusion of antiseptics, such as isopropyl alcohol or chlorhexidine, into the central lumen of medical connectors. These caps may be used with medical connectors such as male connectors on the ends of IV tubing and open female Luer ports on catheters and stopcocks.

[0061] Additionally, the pressure-sealed universal antiseptic cap herein has the advantage of being able to contain pressure that can occur in certain situations, such as when a clamp and / or roller on an IV tubing or a valve on a stopcock does not close completely due to non-compliance or accident, resulting in fluid leakage, medication waste, dangerous medication spillage, or even patient blood loss.

[0062] The following definitions are provided for terms used in this disclosure.

[0063] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0064] 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.

[0065] As used herein, the term "Luer connector" refers to a connecting collar, a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of slightly tapered male and female interlocking tubes for better connection with even a simple press / twist fit. Luer connectors can optionally include an additional outer rim of threads, allowing the Luer connector to be more securely secured. The male end of a Luer connector is typically associated with a flush syringe and can interlock and connect to a female end located on a vascular access device (VAD). Luer connectors have a distal end, a proximal end, an irregularly shaped outer wall, and a shaped central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. Luer connectors also have a distal end channel that removably attaches the Luer connector to the hub of the VAD and a proximal end channel that removably attaches the Luer connector to the syringe reservoir.

[0066] As will be readily understood by one of ordinary skill in the relevant art, terms such as "bond," "hole," "tip," "hub," "screw," "sponge," "prong," "projection," "tab," "slope," "wall," "top," "side," "bottom," and other descriptive terms are used herein for ease of understanding, but are not intended to limit the components that may be used in combination or individually to implement various aspects of the embodiments of the present disclosure.

[0067] The matters exemplified in this description are provided to facilitate a comprehensive understanding of the exemplary embodiments of the present disclosure. Therefore, those skilled in the art will recognize that various changes and modifications can be made to the embodiments described herein without departing from the scope and spirit of the present disclosure. In addition, descriptions of well-known functions and structures are omitted for the sake of clarity and conciseness.

[0068] Exemplary embodiments of the present disclosure provide a cap that can reduce by approximately half the number of device types and logistics currently required in a hospital setting to connect, cap, and / or sterilize male and female threaded fluid luer connectors by including features that allow a single cap or device to be used with both male and female threaded fittings.

[0069] In exemplary implementations of embodiments of the present disclosure, the cap, connection cap, or antiseptic cap includes integrated threads or threads and other features in any and all combinations that allow it to mate with both male and female threaded fittings. The male threaded fitting is present on a female luer connector. The female threaded fitting is present on a male luer connector. The threads can be sufficient to mate with a mating feature (such as one or more protrusions, projections, and / or threads) on the hub or tip of a needleless connector, for example, as described in related U.S. patent applications Ser. Nos. 15 / 408,278 and 15 / 408,187, filed Jan. 17, 2017.

[0070] According to yet another exemplary implementation of an embodiment of the present disclosure, both the male and female threads mate with each other on the inner and outer surfaces of the threaded projection.

[0071] According to yet another exemplary implementation of an embodiment of the present disclosure, the female threads are of a size and thread pattern that mates with a standard ISO 594-2 type male fitting and / or the male threads are of a size and thread pattern that mates with a standard ISO 594-2 type female fitting, an example of an ISO 594-2 type fitting is a Q-style fitting.

[0072] According to another further exemplary implementation of an embodiment of the present disclosure, the cap is compatible with an ISO 80369-7 connector.

[0073] In one or more embodiments, the female luer connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc. In one or more embodiments, the male connector may be an intravenous tubing end, a stopcock, or a male locking luer.

[0074] The caps herein can achieve disinfection when used with a Luer connector by incorporating a disinfecting sponge into the cap cavity. The cap is designed to be compatible with various disinfectants. In one or more embodiments, the disinfectant in the disinfecting sponge can include a variant of alcohol or chlorhexidine. In one or more embodiments, the disinfectant is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the antiseptic comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the antiseptic is a fluid or a gel.

[0075] During use, when connected to a female or male luer connector, compressing the disinfecting sponge against the top wall of the cap housing allows the connector to come into contact with the disinfectant, thereby disinfecting the female or male luer connector.

[0076] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0077] Referring now to the drawings, in which like reference numerals indicate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows.

[0078] 1 is a perspective side view of an exemplary medical assembly 20 according to one embodiment, in which a cap 5 according to any embodiment disclosed herein is attached to a medical connector 10 that is attached to, for example, tubing 15. The caps herein are suitable for attachment to both male and / or female medical connectors. Male and / or female connectors are used to connect to medical devices such as catheters and tubing.

[0079] 2 provides an exploded cross-sectional perspective top view along longitudinal axis "a" of an exemplary cap according to one embodiment. The cap 100 includes a housing 102, a protrusion 114, an elongated member 130, an insert 150, and a disinfecting sponge 200. In this embodiment, the pressure seal is a combination of the elongated member 130 and the insert 150, where the insert 150 includes a top edge 151 and a bottom wall 152, spanning a side wall 154 of the insert 150 therebetween. The top edge 151 of the insert 150 includes an inner surface 158. The insert 150 engages with the elongated member 130 along the inner surface 158 of the top edge 151. In one or more embodiments, the insert 150 snap-fits onto the elongated member 130. When assembled, the insert 150 resides in a hollow 206 defined by the disinfecting sponge 200.

[0080] As shown in the cross-sectional perspective top view of FIG. 3 , the housing 102 comprises a top wall 104, a side wall 106, a protrusion 114, and an elongated member 130. The side wall 106 is essentially cylindrical. The side wall 106 defines a first cavity 112 and an open bottom 108, which defines an opening 110. The elongated member 130 extends from a first end 138 attached to the inner surface of the top wall 104 of the housing 102 to a second end 140. The protrusion 114 is disposed within the first cavity 112 and may be essentially cylindrical and coaxial with the side wall 106. The opening 110 is disposed in the open bottom 108 of the housing 102. The inner surface of the top wall 104 may form the top of the cavity 112. In one embodiment, the protrusion 114 is integrally formed with the housing 102. In another embodiment, the protrusion 114 is attached to the top wall 104 of the housing 102, for example, by a snap-fit ​​attachment. A second cavity 120 of the housing 102 is defined by an inner surface 116 of the protrusion 114. The inner surface 116 includes internal threads 122. The protrusion 114 also has an outer surface 118 including external threads 124. In one or more embodiments, the internal threads 122 have a size and pitch to mate with a female connector threaded fitting, such as a female Luer connector. Such connectors are generally and commonly used as catheters and other fluid-tight protective connectors in medical applications. The internal threads 122 are sufficient to couple with a mating feature of a female needleless connector, such as a threaded fitting with external threads. The external threads 124 are sufficient to couple with a mating feature of a male needleless connector, such as a threaded fitting with internal threads. In one or more embodiments, the protrusion 114 can include one or more cantilevered prongs, each separated by one or more gaps. In one or more embodiments, at least one of the prongs can be configured to bend to facilitate an interference fit between the protrusion and a mating feature of the male or female needleless connector. In one or more embodiments, the protrusion 114 can extend from essentially the inner surface of the top wall 104 toward the open bottom 108 of the housing 102. In one or more embodiments, the protrusion 114 can extend essentially parallel to the side wall 106 of the housing.

[0081] 4, a partial cross-sectional view of elongated member 130 shows upper slide 136a extending inwardly from first end 138 (not shown) followed by tapered ramp 134. Ramped portion 134 terminates to meet shoulder 132 of elongated member 130. At second end 140 of elongated member 130 is lower slide 136b. An insert slidably engages elongated member 130.

[0082] FIG. 5 provides a cross-sectional view, and FIG. 6 provides a perspective top view of an insert 150 according to one embodiment. The insert 150, which may be referred to as a slidable insert, includes a substantially cylindrical body having a closed bottom wall 152, an open top edge 151, and a sidewall 154 therebetween. The top edge 151 hangs radially above the insert sidewall 154, which defines an opening 160. The sidewall 154 defines a chamber 156 within the insert. A plurality of slits 164 extend radially around the top edge 151, defining a plurality of prongs 162 around the top edge 151 of the insert 150. A face 158 of the prongs 162 is chamfered from the top edge 151 of the insert 150. The prongs 162 have a bottom end at which each slit end 166a, 166b, 166c, and 166d is defined. The slits 164 provide flexibility to each prong 162, allowing the insert 150 to slide along the elongated member (e.g., item 130 in FIGS. 2-3) when a force is applied along the central axis (e.g., "a" in FIG. 2), such as when a needleless connector or IV tubing end is attached to the cap. The insert can be made of plastic, or thermoplastic elastomer (TPE), or a blend of plastic (e.g., polypropylene (PP) or polyethylene (PE)) and TPE material. The insert is suitable, for example, for a universal antiseptic cap used with both needleless connectors and stopcocks.

[0083] Pressure seals including an elongated member and an insert may also be included in reversible caps, including, but not limited to, female antiseptic caps such as the BDPureHub®. The pressure seal allows the female antiseptic cap to be used with a stopcock. In one embodiment, the cap includes a housing having a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity within the housing for receiving a hub of the medical connector; internal threads on an inner surface of the cylindrical sidewall sufficient to couple with a threaded fitting of the medical connector; an antiseptic sponge configured within the first cavity; an elongated member attached to the housing; and an insert slidably engaging the elongated member and disposed adjacent to a surface of the antiseptic sponge.

[0084] FIG. 7 provides a cross-sectional view of an insert 170 according to another embodiment, where the insert has a tapered end. The insert 170, which may be referred to as a slidable insert, includes a substantially cylindrical body having a closed bottom wall 172, an open top edge 171, and a sidewall 174 therebetween. The top edge 171 hangs radially above the insert sidewall 174, which defines an opening 180. The sidewall 174 defines a chamber 176 within the insert. A plurality of slits 184 extend radially around the top edge 171, defining a plurality of prongs 182 around the top edge 171 of the insert 170. The faces 178 of the prongs 182 are chamfered from the top edge 171 of the insert 170. The prongs 182 have a bottom end at which each slit end 186a, 186b, 186c, and 186d is defined. Bottom wall 172 further comprises a tapered end 188 that can be configured to complement a connector and / or medical device to create a sealed contact. In one or more embodiments, the exterior shape of insert 150 has tapered end 188 with a range of angles that can be sufficiently complementary to a luer taper. When the insert engages with the open lumen of a medical luer connector, such as a catheter or stopcock, the complementary inner luer wall exerts radial pressure on the insert, tightening the snap fit and preventing the insert from moving along the central axis, even when subjected to a force along the central axis.

[0085] The cap of the present disclosure includes a disinfectant sponge, allowing practitioners to streamline the disinfection process. FIG. 8 provides a perspective top view, and FIG. 9 provides a perspective top view, of a substantially symmetrical disinfectant sponge according to one embodiment. The disinfectant sponge 200 has a generally cylindrical body with a sidewall 204 spanning between a slotted end 202 and an open end 208 having an end wall 210. In the embodiment of FIGS. 8-9, a slot 212 extends through the diameter of the slotted end 202 on opposing portions of the sidewall 204. In one or more embodiments, the slot 212 extends less than approximately halfway along the sidewall 204. The sidewall 204 defines a hollow 206. The slot allows, for example, the luer tip of a male luer connector to be inserted into the cavity of the hollow cylinder, allowing the sponge sidewall to interact with the side of the male luer connector to release disinfectant onto the luer surface. A male luer connector is screwed onto the cap, opening the slot, and the luer presses against both sides of the sponge, opening the slot.

[0086] FIG. 10 provides a cross-sectional perspective top view of a substantially symmetrical antiseptic sponge according to another embodiment. The antiseptic sponge 201 has a generally cylindrical body with a sidewall 205 spanning between a slotted end 202 and an open end 209 having an end wall 211. In the embodiment of FIG. 10, a slot 213 extends from the end wall 311 along the sidewall 205 through the diameter of the slotted end 202. The sidewall 205 defines a hollow 207. Optionally, in one or more embodiments, the slot may have intermittent connections between portions of the sidewall 205 so that the sponge is a single piece for handling. The slot may, for example, allow the luer tip of a male luer connector to be inserted into the cavity of the hollow cylinder, allowing the sponge sidewalls to interact with the sides of the male luer connector and release antiseptic onto the luer surface. The slot opens when the male luer connector is screwed onto the cap, and the luer pushes against both sides of the sponge, opening the slot.

[0087] 11 diagrammatically shows a cross-sectional perspective top view of the cap according to FIG. 2 in an assembled state. The cap 100 comprises a housing 102, a top wall 104, a side wall 106, an open bottom 108 defining an opening 110, a protrusion 114, and an elongated member 130 onto which an insert 150 is shown snap-fit ​​into place. The insert 150 resides in a hollow defined by a disinfecting sponge 200, which in turn resides in a cavity defined by the inner surface of the protrusion 114. The side wall 106 defines a cavity 112 available for receiving a connector hub. In one or more embodiments, when assembled, the disinfecting sponge 200 is in direct contact with the inner surface of the top wall 104.

[0088] In exemplary embodiments, a peel seal may be provided to seal opening 110 prior to use of cap 100, for example, by attaching it to a rim surface of open bottom 108 of housing 102. In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel back top. In certain embodiments, the peelable seal is heat or induction sealed to the open end of the cap. In one or more embodiments, the peelable seal comprises a moisture barrier. According to exemplary embodiments of the present disclosure, cap 100 can receive the tip or hub of a needleless connector within cavity 112, for example, after the peel seal sealing cavity is removed or when the peel seal film is pierced, thereby threadably securing the tip of the needleless connector within cavity 112.

[0089] 12 provides an exploded cross-sectional perspective top view along longitudinal axis "b" of an exemplary cap according to one embodiment. Cap 300 comprises a housing 302, a top wall 304, a substantially cylindrical sidewall 306, and a protrusion 314. Sidewall 306 is essentially cylindrical. Sidewall 306 defines a first cavity 312 and an open bottom 308, which defines an opening 310. Protrusion 314 is disposed within first cavity 312 and may be essentially cylindrical and coaxial with sidewall 306. Opening 310 is disposed in open bottom 308 of housing 302. The inner surface of top wall 304 may form an upper portion of cavity 312. In one embodiment, protrusion 314 is integrally formed with housing 302. In another embodiment, the protrusion 314 is attached to the top wall 304 of the housing 302, for example, by a snap-fit ​​attachment. A second cavity 320 of the housing 302 is defined by an inner surface 316 of the protrusion 314. The inner surface 316 includes internal threads 322. The protrusion 314 also has an outer surface 318 including external threads 324. In one or more embodiments, the internal threads 322 have a size and pitch to mate with a female connector threaded fitting, such as a female Luer connector. Such connectors are generally and commonly used as catheters and other fluid-tight protective connectors in medical applications. The internal threads 322 are sufficient to couple with a mating feature of a female needleless connector, such as a threaded fitting with external threads. The external threads 324 are sufficient to couple with a mating feature of a male needleless connector, such as a threaded fitting with internal threads. In one or more embodiments, the protrusion 314 can include one or more cantilevered prongs, each separated by one or more gaps. In one or more embodiments, at least one of the prongs can be configured to bend to facilitate an interference fit between the protrusion and a mating feature of the male or female needleless connector. In one or more embodiments, the protrusion 314 can extend from essentially the inner surface of the top wall 304 toward the open bottom 308 of the housing 302. In one or more embodiments, the protrusion 314 can extend essentially parallel to the side wall 306 of the housing.

[0090] In this embodiment, the pressure seal is a flexible insert 350 having a top edge 351 and a bottom wall 352, spanning a side wall 354 of the flexible insert 350. The bottom wall 352 of the flexible insert 350 includes a tapered surface 355. When assembled, the insert 350 resides in the hollow 206 defined by the antiseptic sponge 200. In one or more embodiments, the flexible insert is disposed completely hollow when in an uncompressed state.

[0091] FIG. 13 provides a perspective bottom view of a flexible insert 350, according to one embodiment. The flexible insert 350 comprises a substantially cylindrical body between a bottom wall 352 that is closed and has a tapered surface 355, and a top edge 351 that spans a side wall 354 therebetween. The top edge 351 may be configured to accommodate a cap design as desired. In one or more embodiments, the flexible insert 350 is attached to the top wall of a housing (e.g., item 304 in FIG. 12 ). In FIG. 14 , the top edge 351 of the flexible insert 350 comprises an attachment feature 357 for attachment to the inner surface of the top wall of a cap housing. In FIG. 14 , the attachment feature 357 is a central opening in the top wall 351. In FIG. 15 , the top edge 351 comprises an attachment feature 359, which is a channel through the diameter of the top wall 351.

[0092] The outer shape of the flexible insert 350 is sufficiently complementary to an open lumen luer connector for engagement. When the flexible insert 350 engages with an open lumen in a luer connector, such as a catheter or stopcock, the complementary inner luer wall exerts radial pressure on the insert, creating an interface fit. The flexible insert 350 may define a hollow chamber within the insert. The walls of the flexible insert 350 may be breathable and / or porous to provide channels, orifices, or air passages connecting the inside and outside of the insert's chamber to allow for compression.

[0093] The flexible insert may be a solid material that is soft to compress longitudinally so that it can retract toward the top wall at the closed end of the cap housing when the cap is attached to male and closed female luer connectors, such as needleless connectors and IV tubing ends, and may be sufficiently rigid in the longitudinal direction so that it can form a sufficient interference with an open luer, such as a catheter or stopcock.

[0094] Pressure seals including flexible inserts may also be included in reversible caps, including, but not limited to, female antiseptic caps such as the BD PureHub®. The pressure seal allows the female antiseptic cap to be used with a stopcock. In one embodiment, the cap includes a housing having a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity within the housing for receiving the hub of the medical connector; internal threads on an inner surface of the cylindrical sidewall sufficient to couple with a threaded fitting of the medical connector; an antiseptic sponge configured within the first cavity; and a flexible insert attached to the housing and positioned adjacent to a surface of the antiseptic sponge.

[0095] 16 diagrammatically shows a cross-sectional perspective top view of the cap according to FIG. 12 in an assembled state. The cap 300, comprising a housing 302, an upper core 304, a sidewall 306, and an open bottom 808 defining an opening 310, is shown with a flexible insert 350 in place. The flexible insert 350 resides in the hollow defined by the antiseptic sponge 200, which in turn resides in the cavity defined by the inner surface of the protrusion 314. The sidewall 306 defines a cavity 312 available for receiving the hub of a connector. In one or more embodiments, when assembled, the antiseptic sponge 200 is in direct contact with the inner surface of the top wall 304.

[0096] In exemplary embodiments, a peel seal may be provided to seal the opening 310 prior to use of the cap 300, for example, by attaching it to a rim surface of the open bottom 308 of the housing 302. In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel back top. In certain embodiments, the peelable seal is heat or induction sealed to the open end of the cap. In one or more embodiments, the peelable seal comprises a moisture barrier. According to exemplary embodiments of the present disclosure, the cap 300 can receive the tip or hub of a needleless connector within the cavity 312, for example, after the peel seal sealing cavity is removed or when the peel seal film is pierced, thereby threadably securing the tip of the needleless connector within the cavity 312.

[0097] 17 illustrates an exemplary assembly 400 of a cap 100 in a cross-sectional side view and a medical connector 450 in a partial side schematic view, according to one embodiment. The cap 100 includes a housing 102, a protrusion 114, an elongated member 130, an insert 150 that snap-fits and slidably engages the elongated member 130, and an antiseptic sponge 200. The connector 450 is a female medical connector having an open female Luer port and may be a needleless connector such as a catheter or stopcock, and may include an open lumen 452, a lumen end 454, and a male threaded fitting 458. The male threaded fitting 458 of the connector 450 engages with internal threads 122 on the interior surface of the protrusion 114. When insert 150 engages open lumen 452, complementary inner walls, e.g., luer walls, exert radial pressure on insert 150 to tighten the snap fit by bending the insert's prongs inward toward the central axis and preventing the insert from moving along the central axis, even when subjected to a force along the central axis. Luer end 454 presses sponge 200 toward top wall 104 at the closed end of housing 102, allowing disinfectant to be dispensed onto lumen end 454. Insert 150 inhibits and / or prevents disinfectant from entering lumen 452. The insert can also hold high pressure to avoid fluid leakage, for example, if a stopcock valve is not properly closed. In one or more embodiments, cap 400 provides a protective cover for the female luer connector when engaged with the connector, when a threaded fitting from the female luer connector engages internal threads 122 of cap 400 to form a releasable connection.

[0098] FIG. 18A illustrates an exemplary assembly 410 showing the cap 100 in a cross-sectional side view and the medical connector 460 in a partial schematic view, according to one embodiment, and FIG. 18B illustrates a cross-section of a portion of the medical connector 460. The cap 100 includes a housing 102, a protrusion 114, an elongated member 130, an insert 150 that snap-fits and slidably engages the elongated member 130, and an antiseptic sponge 200. The connector 460 is a male medical connector, such as an IV tubing end, including an open lumen 462, an end 464, and a female threaded fitting 468. The female threaded fitting 468 of the connector 460 engages with the external threads 124 on the inner surface of the protrusion 114. When the insert 150 engages the end 464, the prongs on the insert 150 expand radially outward, allowing the insert 150 to move along the elongated member 130 and retract into the top wall 104 at the closed end of the housing 102. The lumen end 464 pushes the sponge 200 toward the top wall 104 at the closed end of the housing 102, allowing the disinfectant to be dispensed onto the lumen end 464. The insert 150 inhibits and / or prevents the disinfectant from entering the open lumen 462. The bottom surface of the insert 150 can cover the open lumen 462 of the luer tip on the connector, thereby mitigating the disinfectant from entering. The insert can provide a seal to retain pressure from the liquid in the central lumen and fluid pathway, preventing leakage. In one or more embodiments, cap 410 provides a protective cover for the male luer connector when engaged with the connector when a threaded fitting from the male luer connector engages with internal threads 122 of cap 410 and forms a releasable connection.

[0099] 19 illustrates an exemplary assembly 420 showing the cap 100 in a cross-sectional perspective top view and a medical connector 470 in a partial side perspective view, according to one embodiment. The cap 100 includes a housing 102, a protrusion 114, an elongated member 130, an insert 150 that snap-fits and slidably engages the elongated member 130, and an antiseptic sponge 200. The connector 470 is a female needleless connector and includes a lumen end 474, a septum 476, and a male threaded fitting 478. When assembled, the male threaded fitting 478 of the connector 470 engages with the internal threads 122 on the interior surface of the protrusion 114. The lumen end 474 pushes the sponge 200 toward the top wall 104 at the closed end of the housing 102, allowing antiseptic to be dispensed onto the lumen end 474. When cap 100 is attached to needleless connector 470, prongs on insert 150 expand radially outward, allowing insert 150 to move along elongated member 130 and retract toward top wall 104 at the closed end of housing 102. This movement prevents insert 150 from pressing against septum 476 of needleless connector 470, thereby avoiding opening a fluid pathway and causing fluid leakage. In one or more embodiments, cap 420 provides a protective cover for the female needleless connector when engaged with the connector when a threaded fitting from the female needleless connector engages internal threads 122 of cap 420 and forms a releasable connection.

[0100] 20 illustrates an exemplary assembly 500 showing a cap 300 in a cross-sectional side view and a medical connector 450 in a partial side view, according to an embodiment. The cap 300 includes a housing 302, a protrusion 314, a flexible insert 350, and an antiseptic sponge 200. The connector 450 is a female medical connector having an open female luer port, and may be a needleless connector such as a catheter or stopcock, and may include an open lumen 452, a lumen end 454, and a male threaded fitting 458. The male threaded fitting 458 of the connector 450 engages with the internal threads 322 on the inner surface of the protrusion 314. When the insert 350 engages with the open lumen 452, a complementary inner wall, e.g., a luer wall, applies radial pressure to the insert 350, creating an interface fit with the inner wall. Lumen end 454 pushes sponge 200 toward top wall 304 at the closed end of housing 302, allowing disinfectant to dispense onto lumen end 454. Insert 350 inhibits and / or prevents disinfectant from entering lumen 452. The insert can also hold high pressure to avoid fluid leakage, for example, if a stopcock valve is not properly closed. In one or more embodiments, cap 500 provides a protective cover for a female Luer connector when engaged with the connector, when a threaded fitting from the female Luer connector engages internal threads 322 of cap 500 and forms a releasable connection.

[0101] FIG. 21 illustrates an exemplary assembly 510 showing a cap 300 in a cross-sectional side view and a medical connector 460 in a partial schematic view, according to one embodiment, and FIG. 18B illustrates a cross-section of the male connector of FIG. 21. The cap 300 includes a housing 302, a protrusion 314, an insert 350, and an antiseptic sponge 200. The connector 460 is a male medical connector, which may be, for example, an IV tubing end including an open lumen 462, an end 464, and a female threaded fitting 468. The female threaded fitting 468 of the connector 460 engages with the external threads 324 on the inner surface of the protrusion 314. When the insert 350 engages the open lumen 462, the complementary inner wall exerts radial pressure on the insert 350, creating an interface fit with the inner wall. The lumen end 464 pushes the sponge 200 toward the top wall 304 at the closed end of the housing 302, allowing the disinfectant to be dispensed onto the lumen end 464. The insert 350 inhibits and / or prevents the disinfectant from entering the open lumen 462. The bottom surface of the insert 350 can cover the open lumen 462, thereby mitigating the disinfectant from entering. The insert can provide a sealing function to keep pressure from the liquid in the central lumen and fluid path, preventing leakage.

[0102] 22 illustrates an exemplary assembly 520 showing a cap 300 and a medical connector 470 in a cross-sectional perspective top view, according to one embodiment. The cap 300 includes a housing 302, a protrusion 314, a flexible insert 350, and an antiseptic sponge 200. The connector 470 is a female needleless connector and includes a lumen end 474, a septum 476, and a male threaded fitting 478. When assembled, the male threaded fitting 478 of the connector 470 engages with the internal threads 322 on the inner surface of the protrusion 314. The lumen end 474 pushes the sponge 200 toward the top wall 304 at the closed end of the housing 302, allowing antiseptic to be dispensed onto the lumen end 474. When the insert 350 engages with the open lumen 452, a complementary inner wall, e.g., a luer wall, exerts radial pressure on the insert 350, creating an interface fit with the inner wall. The insert 350 fits well enough so as not to press against the septum 476 of the needleless connector 470 and open the fluid pathway to allow fluid leakage. In one or more embodiments, the cap 520 provides a protective cover for the female luer connector when engaged with the connector when a threaded fitting from the female luer connector engages the internal threads 322 of the cap 520 and forms a releasable connection.

[0103] FIG. 23 diagrammatically illustrates a cap 600 in a cross-sectional side view according to one embodiment. The cap 600 comprises a housing 602, a top wall 604, a substantially cylindrical side wall 606, an open bottom 608 defining an opening 610, a protrusion 614, a flexible insert 650, and a disinfecting sponge 200. The insert 650 resides in a hollow defined by the disinfecting sponge 200, which in turn resides in a cavity defined by the inner surface of the protrusion 614. The side wall 606 defines a cavity 612 available for receiving a connector hub. The protrusion 614 is disposed within the first cavity 612 and may be essentially cylindrical and coaxial with the side wall 606. The opening 610 is disposed in the open bottom 608 of the housing 602. The inner surface of the top wall 604 may form an upper portion of the cavity 612. In one embodiment, the protrusion 614 is integrally formed with the housing 602. In another embodiment, the protrusion 614 is attached to the top wall 604 of the housing 602, for example, by a snap-fit ​​attachment. In this embodiment, the top wall 604 comprises an elongated ring 605 having an inner surface 607. The flexible insert 650 comprises an upper wall 651 having an extension 653. The protrusion 614 comprises a shoulder 616 and an upper lip 615 having an end 617. The upper lip 615 of the protrusion 614 fits over the elongated ring 605, and the end 617 of the upper lip 615 engages the inner surface 607 of the elongated ring 605. The extension 653 of the top wall 651 of the insert 650 resides on the shoulder 616 of the protrusion 614. In this embodiment, the protrusion 614 is formed separately from the housing 602 and snap-fitted onto the elongated ring 605.

[0104] In one or more embodiments, the inner surface of the protrusion 614 has internal threads (not shown) sized and pitch to mate with a female connector threaded fitting, such as a female Luer connector. Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. The internal threads are sufficient to couple with a mating feature of a female needleless connector, such as a threaded fitting with external threads. The external threads 624 are also sufficient to couple with a mating feature of a male needleless connector, such as a threaded fitting with internal threads. In one or more embodiments, the protrusion 614 can include one or more cantilevered prongs, each separated by one or more gaps. In one or more embodiments, at least one of the prongs can be configured to bend to facilitate an interference fit between the protrusion and a mating feature of a male or female needleless connector. In one or more embodiments, the protrusion 614 can extend essentially from the inner surface of the top wall 604 toward the open bottom 608 of the housing 602. In one or more embodiments, the protrusions 614 can extend essentially parallel to the sidewalls 606 of the housing.

[0105] In exemplary embodiments, a peel seal may be provided to seal opening 610 prior to use of cap 600, for example, by attaching it to a rim surface of open bottom 608 of housing 602. In one or more embodiments, the peelable seal comprises an aluminum or multilayer polymer film peel back top. In certain embodiments, the peelable seal is heat or induction sealed to the open end of the cap. In one or more embodiments, the peelable seal comprises a moisture barrier. According to exemplary embodiments of the present disclosure, cap 600 can receive the tip or hub of a needleless connector within cavity 612, for example, after the peel seal sealing cavity is removed or when the peel seal film is pierced, thereby threadably securing the tip of the needleless connector within cavity 612.

[0106] FIG. 24 shows a perspective top view of flexible insert 650, and FIG. 25 shows a perspective cross-sectional view of flexible insert 650 and protrusion 614 of FIG. 23. Flexible insert 650 is closed and comprises a substantially cylindrical body between a bottom wall 652 having a tapered surface 655 and a top edge 651 that spans a side wall 654 therebetween. Top edge 651 may be configured to accommodate a cap design as desired. In this embodiment, flexible insert 650 includes attachment feature 659, which is a channel through the diameter of top wall 651. Top wall 651 of flexible insert 650 includes extension 653 that fits over shoulder 616 of protrusion 614. End 617 of protrusion 614 engages with an elongated ring on the housing (item 605 in FIG. 23).

[0107] The outer shape of the flexible insert 650 is sufficiently complementary to an open lumen luer connector for engagement. When the flexible insert 650 engages with an open lumen in a luer connector, such as a catheter or stopcock, the complementary inner luer wall exerts radial pressure on the insert, creating an interface fit. The flexible insert 650 may define a hollow chamber within the insert. The wall of the flexible insert 650 may be breathable and / or porous to provide channels, orifices, or air passages connecting the inside and outside of the insert's chamber to allow for compression.

[0108] The flexible insert may be a solid material that is soft to compress longitudinally so that it can retract toward the top wall at the closed end of the cap housing when the cap is attached to male and closed female luers, such as needleless connectors and IV tubing ends, and may be sufficiently rigid in the longitudinal direction so that it can form a sufficient interference with an open luer, such as a catheter or stopcock. This flexible insert is suitable for use in reversible antiseptic caps for use with a variety of medical connectors known to those skilled in the art, including those disclosed herein.

[0109] 20-22, when the cap of FIG. 23 is assembled with a medical connector, male or female, the lumen end presses the sponge 200 toward the top wall 604 at the closed end of the housing 602, allowing antiseptic to be dispensed into the lumen end. When the insert 650 engages the open lumen, a complementary inner wall, e.g., a luer wall, applies radial pressure to the insert 650 to form an interface fit with the inner wall, mitigating and / or preventing antiseptic from entering the lumen.

[0110] The caps herein (e.g., 100, 300, 600) can be made from any of several types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or other moldable plastic materials used in medical devices. In one or more embodiments, the cap comprises a polypropylene or polyethylene material.

[0111] According to exemplary implementations of embodiments of the present disclosure, the caps herein may further comprise an outer housing that implements the safety features and designs described in U.S. Patent Application Nos. 62 / 488,266, filed April 21, 2017, and 62 / 523,506, filed June 22, 2017, for example, by modifying the top wall, side walls, and / or housing.

[0112] According to yet another exemplary implementation of an embodiment of the present disclosure, the caps herein (e.g., 100, 300, 600) can be implemented with various venting features and designs as described in U.S. Patent Application Nos. 15 / 408,278 and 15 / 408,187, both filed January 17, 2017, by varying, for example, the shape and / or size of the protrusions, and / or the internal and / or external thread configurations (such as pitch, spacing, thickness, and / or other structural features), and / or the configuration of the internal and / or external surfaces.

[0113] In some embodiments, the medical connector includes a needleless injection site, sometimes referred to as a needleless injection port, hub, valve, or device, or a needleless access site, port, hub, valve, or device, including, for example, trademarks such as Clave (available from ICU Medical, Inc.), SmartSite (available from Cardinal Health, Inc.), and Q-Syt (available from Becton, Dickinson, Company). In some embodiments, the caps herein (e.g., 100, 300, 600) can be connected to any of a variety of different needleless injection sites, as described above. In one or more embodiments, after the cap is connected to the connector, the connector remains uncontaminated while connected to the cap, eliminating the need to disinfect the connector (e.g., treat with alcohol swabs) before each reconnection to another connector. The use of the cap can replace standard swabbing protocols for cleaning connectors.

[0114] A further aspect of the present disclosure relates to a method of disinfecting a medical connector, the method comprising connecting a cap of one or more embodiments to the medical connector, the connection comprising engaging threads of the medical connector with threads on an inner or outer surface of a second cavity of the cap when the medical connector is inserted into the cap, such that the medical connector comes into contact with an absorbent material and a disinfectant or an antimicrobial agent.

[0115] Exemplary caps of the present disclosure allow for continuous disinfection of the connector and minimize the ingress of microbial agents.

[0116] To avoid the need to use different types of disinfection caps to clean different types of connectors, the exemplary caps (100, 300, 600) engage both male and female luer connectors, thereby allowing users to disinfect various types of connectors with a single device. When attaching the exemplary caps (100, 300, 600) to a female luer connector, the female luer connector is inserted into the second cavity and threaded onto the internal threads of the exemplary cap. When attaching the cap to a male luer connector, the male luer connector is inserted into the second cavity and threaded onto the external threads of the exemplary cap (100, 300, 600). The disinfectant from the disinfection sponge contacts the female luer connector after inserting it into the second cavity of the exemplary cap (100, 300, 600). The disinfectant in the disinfecting sponge contacts the male luer connector, the female luer connector, and the hemodialysis connector after inserting the connector into the second cavity of the exemplary cap (100, 300, 600).

[0117] Thus, the devices disclosed herein can be attached to both male and female Luer connectors, fulfilling a current need in the art.

[0118] A further aspect of the present disclosure relates to an assembly comprising one or more embodiments of the cap connected to a medical connector, in one or more embodiments, the medical connector being selected from a male luer connector, a female luer connector, and a needleless connector.

[0119] (Embodiment) Various embodiments are listed below. It will be understood that the embodiments described below may be combined with all aspects and other embodiments in accordance with the scope of the invention.

[0120] 1. A cap comprising: a housing having a top wall, an essentially cylindrical sidewall forming a first cavity, an open bottom formed by the cylindrical sidewall having an opening to the first cavity within the housing for receiving a hub of a medical connector; a protrusion extending from the housing and positioned within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to interlock with a threaded fitting of a female medical connector and external threads on the outer surface of the protrusion sufficient to interlock with a threaded fitting of a male medical connector; a disinfecting sponge configured within the second cavity; and a pressure seal attached to the housing and positioned adjacent to a surface of the disinfecting sponge.

[0121] 2. The cap of embodiment 1, wherein upon engagement of the cap and the medical connector, the disinfecting sponge contacts the lumen edge of the medical connector and a pressure seal blocks the lumen of the medical connector, thereby inhibiting the ingress of disinfectant into the lumen.

[0122] 3. The cap of embodiment 2, wherein when the lumen of the medical connector is opened to the cap, a pressure seal enters the lumen, inhibiting the ingress of disinfectant into the lumen.

[0123] 4. The cap of embodiment 2, wherein when the medical connector includes a septum within the lumen, the pressure seal is positioned so as not to create a fluid path through the septum.

[0124] 5. The cap of embodiment 1, wherein the disinfecting sponge comprises a slotted end, an essentially cylindrical sponge side wall defining a hollow end and an open end, and a sponge end wall.

[0125] 6. The cap of embodiment 5, wherein the slotted end of the disinfecting sponge includes a slot extending into opposing portions of the sponge sidewall.

[0126] 7. The cap of embodiment 6, wherein the slots extend along opposing portions of the sponge sidewall to the open end.

[0127] 8. The cap of embodiment 5, wherein the pressure seal is disposed in the hollow of the disinfecting sponge.

[0128] 9. The cap of embodiment 8, wherein in the uncompressed state, the pressure seal is disposed completely hollow.

[0129] 10. The cap of embodiment 5, wherein the sponge end wall is in direct contact with the inner surface of the top wall.

[0130] 11. In one or more embodiments, the pressure seal comprises an elongated member and an insert, the elongated member extending from an inner surface of the top wall of the housing, the insert comprising a bottom wall and an essentially cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening, and the insert in slidable engagement with the elongated member.

[0131] 12. The cap of embodiment 11, wherein the inner surface of the upper edge slidably engages the elongated member.

[0132] 13. The cap of embodiment 11, wherein the elongated member includes a shoulder portion, a sloped portion, and one or more slide portions.

[0133] 14. The cap of embodiment 11, wherein the insert is defined by portions of the insert sidewall and includes a plurality of prongs at their upper edges separated by slits.

[0134] 15. The cap of embodiment 14, wherein the faces of the prongs slidably engage the elongated member.

[0135] 16. The cap of embodiment 11, wherein the outer shape of the insert sidewall comprises a tapered surface effective to complement the inner surface of the lumen of the medical connector.

[0136] 17. The cap of embodiment 11, wherein the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or a combination thereof.

[0137] 18. The cap of embodiment 1, wherein the pressure seal comprises a flexible insert attached to the inner surface of the top wall of the housing.

[0138] 19. The cap of embodiment 18, wherein the flexible insert comprises an elastomeric polymeric material.

[0139] 20. The cap of embodiment 18, wherein the flexible insert includes a top wall, a bottom wall, and an essentially cylindrical, porous insert side wall extending between the top and bottom walls.

[0140] 21. The cap of any preceding embodiment, wherein the upper wall of the flexible insert further comprises an extension that engages with the upper lip of the protrusion.

[0141] 22. The cap of any one of embodiments 18 to 21, wherein the flexible insert is breathable.

[0142] 23. In another aspect, a cap comprising: a housing comprising a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity in the housing for receiving a hub of a medical connector; and a protrusion extending from the housing and located within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to mate with mating features of a medical connector comprising a female medical connector and external threads on the outer surface of the protrusion sufficient to mate with mating features of a male medical connector; An antiseptic sponge configured within a cavity, the antiseptic sponge having a slotted end, an essentially cylindrical sponge side wall defining a hollow and an open end, and a sponge end wall; and a pressure seal disposed within the hollow of the antiseptic sponge, the pressure seal comprising an elongated member extending from the inner surface of the housing's cylindrical wall, and an insert including a bottom wall and an essentially cylindrical insert side wall, the insert side wall forming a chamber, an upper edge of the insert side wall defining an opening, the insert slidably engaging with the elongated member, and when engaged with the medical connector of the cap, the antiseptic sponge contacts the edge of the lumen of the medical connector, and the insert of the pressure seal blocks the lumen of the medical connector to inhibit infiltration of antiseptic into the lumen.

[0143] 24. The cap of embodiment 23, wherein the inner surface of the upper edge slidably engages the elongated member.

[0144] 25. The cap of embodiment 23, wherein the elongated member includes a shoulder portion, a sloped portion, and one or more slide portions.

[0145] 26. The cap of embodiment 23, wherein the insert sidewall comprises a plurality of prongs defined by portions of the insert sidewall and having upper edges separated by slits.

[0146] 27. The cap of embodiment 26, wherein the surface of the prong slidably engages the elongated member.

[0147] 28. The cap of embodiment 23, wherein the outer shape of the insert side wall comprises a tapered surface effective to complement the inner surface of the lumen of the medical connector.

[0148] 29. The cap of embodiment 23, wherein the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or a combination thereof.

[0149] 30. Another aspect is a cap comprising a housing including a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom formed by the cylindrical sidewall with an opening to the first cavity within the housing for receiving a hub of a medical connector; a protrusion extending from the housing and positioned within the first cavity, the protrusion having an inner and outer surface, the inner surface of the protrusion defining a second cavity, internal threads on the inner surface of the protrusion sufficient to mate with mating features of a medical connector comprising a female medical connector; The external threads have protrusions sufficient to engage with mating features of the male medical connector, and a disinfecting sponge configured within the second cavity has a slotted end, an essentially cylindrical sponge side wall and sponge end wall defining a hollow and an open end, and a pressure seal disposed within the hollow of the disinfecting sponge, the pressure seal having a flexible insert attached to the inner surface of the cylindrical wall of the housing, and when engaged with the medical connector of the cap, the disinfecting sponge contacts the edge of the lumen of the medical connector and the pressure seal blocks the lumen of the medical connector to prevent disinfectant from entering the lumen.

[0150] 31. The cap of embodiment 30, wherein the flexible insert comprises an elastomeric polymeric material.

[0151] 32. The cap of embodiment 30, wherein the flexible insert includes a top wall, a bottom wall, and an essentially cylindrical, porous insert side wall extending between the top and bottom walls.

[0152] 33. The cap of any preceding embodiment, wherein the upper wall of the flexible insert further comprises an extension that engages with the upper lip of the protrusion.

[0153] 34. The cap of any one of embodiments 30-33, wherein the flexible insert is breathable.

[0154] 35. The cap of any preceding embodiment, wherein the medical connector is selected from a male luer connector, a female luer connector, and a needleless connector.

[0155] 36. The cap of any preceding embodiment, wherein the disinfecting sponge comprises a disinfectant, an antibacterial agent, or a combination thereof.

[0156] 37. The cap of embodiment 36, wherein in one or more embodiments, the antiseptic or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

[0157] 38. The cap of embodiment 37, wherein the antiseptic or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0158] 39. The cap of any one of embodiments 1 to 38, wherein the protrusion is integrally formed with the housing.

[0159] 40. The cap of any one of embodiments 1-38, wherein the protrusion is attached to the inner surface of the upper wall of the housing.

[0160] 41. The cap of any preceding embodiment, wherein the protrusion is snap-fastened or glued to the inner surface of the upper wall of the housing.

[0161] 42. The cap of any preceding embodiment, wherein the projection includes an upper lip that engages with an elongated ring extending from the inner surface of the upper wall of the housing.

[0162] 43. A further aspect is a method of disinfecting a medical connector, comprising connecting the cap of any preceding embodiment to a medical connector by engaging threads of the medical connector with the internal or external threads of the prong such that an end of the medical connector contacts the disinfecting sponge and a pressure seal inhibits ingress of disinfectant into the lumen of the medical connector.

[0163] 44. A medical assembly comprising the cap of any one of embodiments 1 to 42 connected to a medical connector.

[0164] 45. The medical assembly of embodiment 44, wherein the medical connector is a female medical connector having a male threaded fitting selected from the group consisting of a needleless connector, a stopcock, a female luer connector, and a catheter connector.

[0165] 46. ​​The medical assembly of embodiment 44, wherein the medical connector is a male medical connector having a female threaded fitting selected from the group consisting of an intravenous tubing end and a male Luer connector.

[0166] While the present disclosure has been shown and described with reference to specific exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and detail can be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, the disinfecting sponge can include any suitable disinfecting or other application-specific substance and can be made of any suitable material. Also, the inner and / or outer housing of the cap can be one-off molded or made by other suitable processes. Furthermore, the features or elements of the exemplary implementations of the embodiments of the present disclosure described above and illustrated in the drawings can be implemented individually or in any combination, as will be readily understood by those skilled in the art, without departing from the spirit and scope of the embodiments of the present disclosure.

[0167] Additionally, the included drawings further illustrate non-limiting examples of the implementation of certain exemplary embodiments of the present disclosure and aid in the explanation of the technology related thereto. Any specific or relative dimensions or measurements shown in the above drawings or elsewhere are exemplary and are not intended to limit the scope or content of the inventive designs or methods as would be understood by one of ordinary skill in the relevant art of the invention.

[0168] Other objects, advantages and salient features of the present disclosure will become apparent to those skilled in the art from the provided details, which, taken in conjunction with the accompanying drawings, disclose illustrative embodiments of the present disclosure.

[0169] References throughout this specification to "one embodiment," "a particular embodiment," "one or more embodiments," or "an embodiment" mean that a particular feature, structure, material, or characteristic described in connection with an embodiment is included in at least one embodiment of the disclosure. That is, the appearances of phrases such as "in one or more embodiments," "in a particular embodiment," "in one embodiment," or "in an embodiment" in various places throughout this specification do not necessarily refer to the same embodiment of the disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0170] Although the present disclosure has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and apparatus without departing from the spirit and scope of the invention. Therefore, it is intended that the present disclosure cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. A cap, A housing, The upper wall, a cylindrical sidewall defining a first cavity; an open bottom defined by a cylindrical sidewall having an opening to the first cavity in the housing for receiving a hub of a medical connector; a protrusion extending from the housing and disposed within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; internal threads on the inner surface of the protrusion, the internal threads interlocking with a threaded joint of a female medical connector; and a housing including external threads on the outer surface of the protrusion, the external threads interlocking with a threaded joint of a male medical connector; a disinfecting sponge configured within the second cavity; a pressure seal attached to the housing and positioned adjacent a surface of the disinfecting sponge; the pressure seal includes an elongated member and an insert; the elongated member extends from an inner surface of the top wall of the housing; A cap, wherein the insert includes a bottom wall and a cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening, the insert in slidable engagement with the elongated member.

2. 2. The cap of claim 1, wherein upon engagement of the cap with the medical connector, the disinfecting sponge contacts the lumen end of the medical connector and the pressure seal blocks the lumen of the medical connector, thereby inhibiting ingress of disinfectant into the lumen.

3. The cap of claim 2 , wherein when the lumen of the medical connector is opened to the cap, the pressure seal enters the lumen and inhibits ingress of the disinfectant into the lumen.

4. The cap of claim 2 , wherein when the medical connector includes a septum within the lumen, the pressure seal is positioned to avoid creating a fluid path through the septum.

5. 2. The cap of claim 1, wherein the antiseptic sponge comprises a slotted end, a cylindrical sponge side wall defining a hollow and an open end, and a sponge end wall.

6. 6. The cap of claim 5, wherein said slotted end of said antiseptic sponge includes a slot extending into opposing portions of said sponge sidewall.

7. The cap of claim 6 , wherein said slots extend along opposing portions of said sponge sidewall to said open end.

8. The cap of claim 5 , wherein the pressure seal is disposed in a hollow space of the disinfecting sponge.

9. The cap of claim 8 , wherein in an uncompressed state, the pressure seal is disposed completely within the hollow.

10. The cap of claim 5 wherein said sponge end wall is in direct contact with said inner surface of said top wall.

11. The cap of claim 10 , wherein an inner surface of the top edge slidably engages the elongated member.

12. The cap of claim 10 , wherein the elongated member includes a shoulder portion, a sloped portion, and one or more slide portions.

13. The cap of claim 10 , wherein the insert is defined by a portion of the insert sidewall, and the top edge comprises a plurality of prongs separated by slits.

14. The cap of claim 13 , wherein a surface of the prong slidably engages the elongated member.

15. The cap of claim 10 , wherein the outer shape of the insert sidewall comprises a tapered surface effective to complement an inner surface of the lumen of the medical connector.

16. The cap of claim 10 , wherein the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or a combination thereof.

17. The cap of claim 1 , wherein the pressure seal comprises a flexible insert attached to an inner surface of the top wall of the housing.

18. The cap of claim 17 , wherein the flexible insert comprises an elastomeric polymeric material.

19. 18. The cap of claim 17, wherein the flexible insert comprises the top wall, the bottom wall, and a cylindrical, porous insert sidewall extending between the top and bottom walls.

20. The cap of claim 19 , wherein the top wall of the flexible insert further comprises an extension that engages an upper lip of the projection.

21. The cap of any one of claims 17 to 20, wherein the flexible insert is breathable.

22. A cap, A housing, The upper wall, a cylindrical sidewall defining a first cavity; an open bottom defined by said cylindrical sidewall with an opening to said first cavity in said housing for receiving a hub of a medical connector; a housing including a protrusion extending from the housing and disposed within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; internal threads on the inner surface of the protrusion that interlock with a mating feature of the medical connector that comprises a female medical connector; external threads on the outer surface of the protrusion that interlock with a mating feature of the medical connector that comprises a male medical connector; an antiseptic sponge configured within the second cavity, the antiseptic sponge including a slotted end, a cylindrical sponge side wall defining a hollow and an open end, and a sponge end wall; a pressure seal disposed in the hollow of the disinfecting sponge, the pressure seal comprising: an elongated member extending from an inner surface of the top wall of the housing; an insert having a bottom wall and a cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening and slidably engaging the elongated member; When the cap and the medical connector are engaged, the disinfecting sponge contacts the lumen end of the medical connector and the insert of the pressure seal blocks the lumen of the medical connector, thereby inhibiting ingress of disinfectant into the lumen.

23. The cap of claim 22 , wherein an inner surface of the top edge is in slidable engagement with the elongated member.

24. The cap of claim 22 , wherein the elongated member includes a shoulder portion, a sloped portion, and one or more slide portions.

25. 23. The cap of claim 22, wherein the insert sidewall comprises a plurality of prongs defined by portions of the insert sidewall and the top edge separated by slits.

26. 26. The cap of claim 25, wherein a surface of the prong slidably engages the elongated member.

27. 23. The cap of claim 22, wherein the outer shape of the insert sidewall comprises a tapered surface effective to complement an inner surface of the lumen of the medical connector.

28. 23. The cap of claim 22, wherein the insert comprises a polymeric material selected from the group consisting of polyethylene, polypropylene, a thermoplastic elastomer (TPE), or a combination thereof.

29. A cap, A housing, The upper wall, a cylindrical sidewall defining a first cavity; an open bottom defined by said cylindrical sidewall with an opening to said first cavity in said housing for receiving a hub of a medical connector; a housing comprising: a protrusion extending from the housing and disposed within the first cavity, the protrusion having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity; internal threads on the inner surface of the protrusion that interlock with a mating feature of the medical connector that comprises a female medical connector; external threads on the outer surface of the protrusion that interlock with a mating feature of the medical connector that comprises a male medical connector; an antiseptic sponge configured within the second cavity, the antiseptic sponge including a slotted end, a cylindrical sponge side wall defining a hollow and an open end, and a sponge end wall; a pressure seal disposed in the hollow of the disinfecting sponge, the pressure seal comprising an elongated member and a flexible insert attached to an inner surface of the top wall of the housing; the elongated member extends from the inner surface of the top wall of the housing; the flexible insert includes a bottom wall and a cylindrical insert sidewall, the insert sidewall forming a chamber, an upper edge of the insert sidewall defining an opening, the flexible insert slidably engaging the elongated member; When the cap and the medical connector are engaged, the disinfecting sponge contacts the lumen end of the medical connector and the pressure seal blocks the lumen of the medical connector, thereby inhibiting ingress of disinfectant into the lumen.

30. 30. The cap of claim 29, wherein the flexible insert comprises an elastomeric polymeric material.

31. 30. The cap of claim 29, wherein the flexible insert comprises the top wall, the bottom wall, and a cylindrical, porous insert sidewall extending between the top and bottom walls.

32. 32. The cap of claim 31, wherein the top wall of the flexible insert further comprises an extension that engages an upper lip of the projection.

33. The cap of any one of claims 29 to 32, wherein the flexible insert is breathable.

34. The cap of any one of claims 29 to 33, wherein the medical connector is selected from a male luer connector, a female luer connector, and a needleless connector.

35. The cap of any one of claims 29 to 34, wherein the disinfecting sponge comprises a disinfectant, an antibacterial agent, or a combination thereof.

36. 36. The cap of claim 35, wherein the disinfectant or antimicrobial agent is selected from the group consisting of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

37. 37. The cap of claim 36, wherein the antiseptic or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

38. The cap of any one of claims 1 to 37, wherein the projection is integrally formed with the housing.

39. The cap of any one of claims 1 to 37, wherein the projection is attached to the inner surface of the top wall of the housing.

40. 40. The cap of claim 39, wherein the projection is snap-fitted or glued to the inner surface of the top wall of the housing.

41. 41. The cap of claim 40, wherein the projection includes an upper lip that engages an elongated ring extending from the inner surface of the top wall of the housing.

42. 1. A method for disinfecting a medical connector, comprising: A method for disinfecting a medical connector, comprising connecting the cap of any one of claims 1 to 41 to the medical connector by engaging the threads of the medical connector with the internal or external threads of a protrusion such that an end of the medical connector contacts the disinfecting sponge and the pressure seal inhibits ingress of disinfectant into the lumen of the medical connector.

43. A medical assembly comprising the cap of any one of claims 1 to 41 connected to a medical connector.

44. 44. The medical assembly of claim 43, wherein said medical connector is a female medical connector having a male threaded fitting selected from the group consisting of a needleless connector, a stopcock, a female luer connector, and a catheter connector.

45. 44. The medical assembly of claim 43, wherein said medical connector is a male medical connector having a female threaded fitting selected from the group consisting of an intravenous tubing end and a male Luer connector.

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