Patent Publication Number: US-2021187267-A1

Title: Universal Disinfection Cap

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority under 35 U.S.C. § 119(e) to U.S. Provisional Application No. 62/952,838, filed Dec. 23, 2019, the disclosures of which are incorporated herein by reference in their entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure generally relates to a device for disinfecting and sterilizing access ports with, e.g., male and female luer fittings, and, in particular, to disinfecting and sterilizing devices capable of accommodating multiple types of connectors. Generally, exemplary embodiments of the present disclosure relate to the field of threaded fitting, including medical caps and medical disinfection caps, and in particular caps and/or disinfection caps with cap covers for use with fluid luer connectors. 
     BACKGROUND 
     Vascular access devices (VAD&#39;s) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD&#39;s: peripheral catheters and central venous catheters. Bacteria and other microorganisms may gain entry into a patient&#39;s vascular system from access hubs and ports/valves upon connection to the VAD to deliver the fluid or pharmaceutical. Each access hub (or port/valve or connection) is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially lethal. 
     In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently accessed to administer medication or other necessary fluids via the catheter to the patient. INS Standards of Practice recommend the use of a needleless connector and state that it should be “consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate/alcohol combination prior to each access.” The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be living on the surface and possibly lead to a variety of catheter related complications including CRBSI. Nurses will typically utilize a 70% isopropyl alcohol (IPA) pad to complete this disinfection task by doing what is known as “scrubbing the hub.” However, compliance to this practice is typically very low. In addition to a lack of compliance to “scrubbing the hub”, it has also been noted through clinician interviews that there is often a variation in scrub time, dry time and the number of times the needleless connector is scrubbed. 
     Throughout the sequence of procedures associated with the transmission of a microorganism that can cause a CRBSI, there are many risks of contact or contamination. Contamination can occur during drug mixing, attachment of a cannula, and insertion into the access hub. Because the procedure to connect to a VAD is so common and simple, the risk associated with entry into a patient&#39;s vascular system has often been overlooked. Presently, the risk to hospitals and patients is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable. 
     In order to decrease CRBSI cases and to ensure VAD&#39;s are used and maintained correctly, standards of practice have been developed, which include disinfecting and cleaning procedures. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines. Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV), and hemodialysis lines may be susceptible to microbe and/or other contaminant ingress. Thus, there is a need for a cap cover that protects disinfection caps from microbe and/or other contaminant ingress. 
     SUMMARY 
     A first aspect of the present disclosure relates to a cap including a housing, a protrusion and a cap cover. 
     The housing can include a top wall, an essentially cylindrical sidewall forming a first cavity, and an open bottom end opposite the top wall formed by the cylindrical sidewall with an opening to the first cavity within the housing for receiving a hub of a female needleless connector or a male needleless connector. The protrusion is positioned within the first cavity and may be integrally formed with the housing or be a removable insert. The protrusion may include a sidewall having an inner surface and an outer surface, the inner surface of the protrusion defining a second cavity and the outer surface facing an inner surface of the essentially cylindrical sidewall of the housing. An inner thread can be included on the inner surface of the protrusion, the inner thread being sufficient to interlock with a mating feature of the female needleless connector. An outer thread can be included on the outer surface of the protrusion, the outer thread being sufficient to interlock with a mating feature of the male needleless connector. In one or more embodiments, the protrusion sidewall includes at least one gap. The sidewall may define one or more prongs separated by one or more respective gaps. In one or more embodiments, at least one of the prongs can be configured to bend to facilitate interference fit between the protrusion and the mating feature of the male needleless connector or female needleless connector. In one or more embodiments, the protrusion can extend essentially from an inner surface of the top wall toward the opposite bottom end of the housing. In one or more embodiments, the protrusion can extend essentially parallel to the sidewall of the housing. The outer surface of the protrusion and the inner surface of the housing define a gap therebetween which may be essentially annular. 
     The cap cover is dimensioned and positioned to cover at least a portion of the gap between the outer surface of the protrusion and the inner surface of the housing. The cap cover may be any suitable shape, such as but not limited to annular and include a top surface, an opposite bottom surface, an exterior wall and an interior wall defining an opening. The cap cover is positioned between the inner surface of the essentially cylindrical sidewall proximal the open bottom end of the housing and the protrusion outer surface, covering at least a portion of the annular gap. In one embodiment at least a portion of the exterior wall of the cap cover is coupled or directly coupled to the inner surface of the housing and the cap cover interior wall is positioned proximal to, adjacent to, directly adjacent to, or abuts the protrusion. The cap cover interior wall may extend to or over an end of the protrusion. In other embodiments at least a portion of the interior wall is coupled or directly coupled to the protrusion end and/or outer surface and the cap cover exterior wall is positioned proximal to, adjacent to, directly adjacent to, or abuts the inner surface of the housing. In either case, the cap cover is free at one edge to deflect downward into the gap upon insertion of a male connector into the cap. 
     The cap cover may be formed of a resilient material such as but not limited to a polymeric or elastomeric material. The cap cover is flexible enough to be deflected when a male connector is attached to the cap. Upon detachment of the male connector from the cap, the cap cover returns to its original position. When a female connector is used, the gap remains covered by the cap cover and prevents material such as grit, saliva, etc. from entering contaminating the cap and/or creating an obstruction which could prevent coupling the cap to a connector. 
     The cap cover may form a part of the housing through 2-shot molding or bonded to the housing through lamination, welding, heat adhesive, adhesive or other bonding method. 
     The cap cover may be made of any suitable material such as but not limited to polymer, elastomer, etc. The thickness of the cap cover may range from 0.1 mm to 3 mm. In some embodiments the thickness of the cap cover is from 0.1 mm to 2 mm. 
     In embodiments in which the protrusion is or includes a removable insert positioned within the first cavity, the removable insert can include a distal end comprising a distal wall, an open proximal end, and a sidewall extending proximally from the distal wall toward the open proximal end. The sidewall can include a split-thread protrusion integrally formed with the distal wall, the split-thread protrusion having an inner surface and an outer surface. The inner surface of the split-thread protrusion defines a second cavity. An inner thread can be included on the inner surface of the split-thread protrusion, the inner thread being sufficient to interlock with a mating feature of the female needleless connector. An outer thread can be included on the outer surface of the split-thread protrusion, the outer thread being sufficient to interlock with a mating feature of the male needleless connector. 
     In one or more embodiments, the split-thread protrusion can include one or more cantilevered prongs separated by one or more respective gaps, in which at least one of the prongs is configured to bend to facilitate interference fit between the protrusion and the mating feature of the male needleless connector or female needleless connector. 
     In one or more embodiments, the sidewall of the insert includes an upper portion and a lower portion. In one or more embodiments, the upper portion of the sidewall can be tapered outward toward the distal wall and the lower portion of the sidewall can be cylindrical. 
     In accordance with one or more embodiments the protrusion includes an absorbent material including a disinfectant or an antimicrobial agent positioned in the second cavity. In one or more embodiments, the disinfectant or antimicrobial agent disinfects an outer surface and an inner surface of the female needleless connector or male needleless connector when a portion of the female needleless connector or male needleless connector is inserted into the second cavity. 
     In accordance with still further embodiments, the cap includes a septum coupled to the open bottom end of the housing thereby forming a seal for maintaining the disinfectant or an antimicrobial agent within the second cavity prior to use of the cap. 
     In one or more embodiments, the cap can include a removable peel seal covering the opening to the second cavity to seal the absorbent material within the second cavity prior to use of the cap. 
     In one or more embodiments, the absorbent material can be a non-woven or woven material. In one or more embodiments, the absorbent material can be a foam or a sponge. In one embodiment, the foam can be a polyurethane foam. In one or more embodiments, the absorbent material can include slits. In one or more embodiments, a compression of the absorbent material toward the top wall of the housing occurs upon connection to the female needleless connector, whereby compression of the absorbent material disinfects the female needleless connector. In one or more embodiments, the absorbent material can be under radial compression by the inner thread on the inner surface of the split-thread protrusion to retain the absorbent material in the second cavity. 
     In one or more embodiments, an exterior wall surface of the sidewall of the housing includes a plurality of grip members. 
     In one or more embodiments, when a hub of the female needleless connector is received within the second cavity, the hub is secured within the second cavity by interlocking at least a portion of the inner thread with a mating feature on the hub of the female needleless connector and the cap cover remains in an undeflected state. In one or more embodiments, when a hub of the male needleless connector is received within the second cavity, the cap cover is deflected in the direction of the housing top wall when a collar of the male needleless connector is received within the gap formed between the protrusion outer wall and inner surface of the housing sidewall and the hub is secured within the first cavity by interlocking at least a portion of the outer thread on the outer surface of the protrusion with a mating feature on a collar of the male needleless connector. 
     In one or more embodiments, the second cavity can extend further into the housing toward the top wall than the portion of the first cavity defined by the gap formed between the protrusion outer wall and inner surface of the housing sidewall. In one or more embodiments, the profile of the inner thread can be essentially parallel to, or coincide with, a profile of the outer thread. 
     In one or more embodiments, the inner thread and outer thread can include an inclined thread pattern. In one or more embodiments, the inner thread and outer thread can include a helical-shaped thread pattern. In one or more embodiments, the inner thread or the outer thread can include one or more gaps in the thread pattern. 
     In one or more embodiments, the inner surface of the protrusion can be essentially parallel to the outer surface of the protrusion. 
     In one or more embodiments, the disinfectant or the antimicrobial agent can be 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, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In one or more specific embodiments, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate. 
     In a still further embodiment an assembly is disclosed including the cap of one or more embodiments herein connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and needleless connector. 
     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 key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subject matter. 
     Additional features and advantages of the 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 disclosure. The features and advantages of the disclosure may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended 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 hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       To assist those of skill in the art in making and using the disclosed energy packet switch and associated systems and methods, reference is made to the accompanying figures, wherein: 
         FIG. 1  is an elevated perspective view of a disinfecting cap with a cap cover in accordance with one or more embodiments disclosed herein; 
         FIG. 2  is a cross-sectional view of the disinfecting cap of  FIG. 1  taken along line A-A′ in accordance with one or more embodiments disclosed herein; 
         FIG. 3  is an elevated perspective view of a disinfecting cap with a cap cover shown in phantom in accordance with one or more embodiments disclosed herein; 
         FIG. 4  is an elevated perspective view of a cap cover in accordance with exemplary embodiments of the disclosure; 
         FIG. 5A  is an elevated perspective view of a disinfecting cap including an absorbent material in accordance with one or more embodiments disclosed herein; 
         FIG. 5B  is a cross-sectional view of the disinfecting cap of  FIG. 5A  taken along line B-B′ in accordance with one or more embodiments disclosed herein; 
         FIG. 6  is a side partial cross-sectional view showing the disinfecting cap of  FIG. 5A  (cross-sectional view) coupled to a male connector (shown in side view) in accordance with one or more embodiments disclosed herein; 
         FIG. 7  is a side partial cross-sectional view showing the disinfecting cap of  FIG. 5B  (cross-sectional view) coupled to a female connector (shown in side view) in accordance with one or more embodiments disclosed herein; 
         FIG. 8  is an elevated perspective view of a disinfecting cap with a cap cover in accordance with one or more embodiments disclosed herein; 
         FIG. 9  is an elevated perspective view of a cap cover in accordance with exemplary embodiments of the disclosure; 
         FIG. 10  is an elevated perspective view of a disinfecting cap with a cap cover in accordance with one or more embodiments disclosed herein; and 
         FIG. 11  is an elevated perspective view of a cap cover in accordance with exemplary embodiments of the disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Before describing several exemplary embodiments of the disclosure, it is to be understood that the disclosure is not limited to the details of construction or process steps set forth in the following description. The disclosure is capable of other embodiments and of being practiced or being carried out in various ways. 
     With respect to terms used in this disclosure, the following definitions are provided. 
     As used herein, the use of “a,” “an,” and “the” includes the singular and plural. 
     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. 
     As used herein, the term “Luer connector” refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and female interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. The Luer connector male end is generally associated with a flush syringe and can interlock and connect to the female end located on the vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe. 
     As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “lock”, “hole”, “tip”, “hub”, “thread”, “sponge”, “prong”, “protrusion”, “tab”, “slope”, “wall”, “top”, “side”, “bottom” and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure. 
     It will be understood that when an element is referred to as being “coupled” or “connected” to another element, it can be directly coupled or connected to the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly coupled” or “directly connected” to another element, there are no intervening elements present. It will be understood that when an element is referred to as being “adjacent” to another element, it can be directly adjacent to the other element or intervening elements may also be present. In contrast, when an element is referred to as being “directly adjacent” to another element, there are no intervening elements present. 
     Like numbers refer to like elements throughout. As used herein the term “and/or” includes any and all combinations of one or more of the associated listed items. 
     The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness. 
     Embodiments of the disclosure pertain to a universal cap for connection to and disinfection of a medical connector, including male connectors and female connectors, the universal cap having a cap cover positioned and dimensioned to prevent microbial ingress, debris and/other contamination from entering the cap. The male connectors and female connectors can be male luer connectors and female luer connectors. Embodiments of the cap include a housing and a protrusion. The housing includes a sidewall, a closed end and an opposite open end. The sidewall of the housing has a length LC extending from the closed end to the opposite open end defining a chamber. The protrusion, which may be integral with the housing or an insert removably coupled to the housing, extends from the closed end and may be formed concentrically within the housing. The protrusion outer wall and inner surface of the housing sidewall define a gap therebetween. The cap cover is configured and positioned to cover at least a portion of the gap formed between the protrusion outer wall and inner surface of the housing sidewall. In one or more embodiments, the bottom open end includes a peripheral ledge extending radially outward from the open end defining an end face and an engagement surface. The protrusion includes an interior wall surface having one or more threads adapted to engage a female luer connector. The exterior wall surface of the protrusion includes one or more threads that are sized and adapted to receive a male luer connector. The cap may further include absorbent material, a disinfectant and/or antimicrobial agent and a peelable seal and/or septum. The cap provides a mechanical barrier for connectors and contains an antimicrobial agent for disinfection. 
     Exemplary embodiments of the present disclosure provide caps that can reduce the number of device types and logistics currently needed in the hospital setting for connecting, capping, and/or disinfecting male and female threaded fluid luer connectors, by roughly half by including in a single cap or device features allowing it to be use with both male and female threaded fittings. 
     In an exemplary implementation of the embodiments of the present disclosure, a cap, connector cap or disinfecting cap includes an integrated thread, or threads, and other features in any and all combinations allowing it to interface with both male and female threaded fittings. 
     According to further exemplary implementations of the embodiments of the present disclosure, configuration of structural elements making up the cap include one or more cantilevered prongs disposed in the inner cavity of the cap, the cantilevered prongs having an inner thread to connect to female medical connectors and an outer thread to connect to male medical connectors, to facilitate securing of the cap onto a female fitting or onto a male fitting, respectively. 
     According to yet further exemplary implementations of the embodiments of the present disclosure, both of the male and female threads may coincide with each other on the inner and outer face of the threaded protrusion. 
     According to still further exemplary implementations of the embodiments of the present disclosure, the cantilevered prong may be in the form of protrusion and may be of a split thread type in which the protrusion may bend in order to allow better interference fit compliance with the fittings. 
     According to still further exemplary implementations of the embodiments of the present disclosure, female threads are sized and have a thread pattern that will engage with a standard ISO594-2 type of male fitting and/or a male threads that are sized and have a thread pattern that will engage with a standard ISO594-2 type of female fitting. An example of an ISO594-2 type of fitting is a Q-style fitting. 
     In one or more embodiments, the female connector may be selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors. 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 male lock luer. 
     Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows. 
     A first aspect of the present disclosure relates to a cap  10  including a housing  20 , a protrusion  30  and a cap cover  100 . With reference to  FIGS. 1-4 , housing  20  can include a top wall  22 , an essentially cylindrical sidewall  26  forming a first cavity  28 , and an open bottom end  23  opposite the top wall  22  formed by the cylindrical sidewall  26 , with an opening  27  within the housing  20  for receiving a hub of a female needleless connector or a male needleless connector. In one embodiment, protrusion  30  is integrally formed with the housing  20  and is positioned within the first cavity  28 . Protrusion  30  includes a sidewall  32  including an inner surface  31  and an outer surface  33 , the inner surface  31  of protrusion  30  defining a second cavity  40 , and an end  37  distal from top wall  22 . 
     In one or more embodiments, the cap  10  of the present disclosure has an inner thread  36  having a size and pitch to engage a threadable segment of a female connector, such as for example, a female luer connector. Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, cap  10  provides a protective cover for a female luer connector when engaged with the connector when threads from the female luer connector engage and form a releasable connection with inner threads  36  of cap  10 . An inner thread  36  can be included on the inner surface  31  of protrusion  30 , the inner thread  36  being sufficient to interlock with a mating feature of the female needleless connector. An outer thread  38  can be included on the outer surface  33  of protrusion  30 , the outer thread  33  being sufficient to interlock with a mating feature of the male needleless connector. In one or more embodiments, the sidewall  32  of protrusion  30  can include one or more prongs  30   a  separated by one or more respective gaps  35 . In one or more embodiments, at least one of the prongs  30   a  can be configured to bend to facilitate interference fit between the protrusion  30  and a mating feature of the male needleless connector or female needleless connector. In one or more embodiments, protrusion  30  can extend essentially from an inner surface  25  of the top wall  22  toward the bottom end  23  of the housing  20 . In one or more embodiments, the protrusion  30  can extend essentially in axial alignment with the sidewall  26  of the housing  20 . 
     In an exemplary implementation of embodiments of the present disclosure, protrusion  30  can be cantilevered, for example by having one or more gaps or cutouts  35 . In an exemplary implementation, at least a portion of the a cantilevered protrusion  30  may bend in order to allow better interference fit compliance with the fitting such as at least one of male connector or female connector. 
     In still further exemplary implementation, protrusion  30  can extend essentially parallel to sidewall  26 . 
     In yet a further exemplary implementation, cavity  40  can extend further into the cap  10  toward inner surface  25  of top wall  22  than the portion of the first cavity  28  defined by the gap  28   a  terminating at top surface  39 . 
     In still yet further exemplary implementation, a profile of the inner thread  36  and/or the inner surface  31  can essentially parallel, or coincide with, a profile of the outer thread  38  and/or the outer surface  33 , respectively. 
     The outer surface  33  of the protrusion  30  and an inner surface  21  of the housing  20  define a gap  28   a  therebetween. The gap  28   a  may be annular. A cap cover  100  is positioned between the inner surface  21  of the sidewall  26  proximal the bottom end  23  of the housing and the protrusion outer surface  33 , covering at least a portion of the annular gap  28   a . The cap cover  100  includes an annular body  102 , which includes an interior wall  104  defining an opening  114  in the annular body  102 , an exterior wall  106 , a top surface  108  and an opposing bottom surface  110 . The thickness and composition of the cap cover  100  are optimally suited to provide the most sufficient coverage of the gap  28   a  and to allow sufficient flexion of the cap cover  100  to be used with male connectors. In one embodiment at least a portion of the exterior wall  106  of the cap cover  100  is coupled or directly coupled to the inner surface  21  of the housing and the cap cover interior wall  104  is positioned proximal to, adjacent or directly adjacent to, or abuts the protrusion outer surface  33 . The cap cover interior wall  104  may extend to or over the end  37  of the protrusion. In other embodiments at least a portion of the interior wall  104  is coupled or directly coupled to the protrusion end  37  and/or outer surface  33 . In other embodiments at least a portion of the interior wall  104  is directly coupled to the protrusion end  37  and/or outer surface  33  and the cap cover exterior wall  106  is positioned proximal to, adjacent to, directly adjacent to or abuts the inner surface  21  of the housing  20 . 
     In at least one embodiment the cap cover  100  includes tabs  112  extending into the opening  114 . The tabs  112  may be configured and oriented to cover openings formed by gaps  35  of protrusion  30 . 
     In one or more embodiments, a seal  60  in the form of a peel seal or septum can be provided to seal the opening  27  prior to use of cap  10 , for example, by attachment to a surface of a rim  29  of an open bottom  23  of housing  20 , as described for example in U.S. patent application Ser. No. 16/261,761 filed Jan. 30, 2019, the entirety of which is incorporated by reference herein. In one or more embodiments, the seal  60  may be disposed over the open bottom  23  of housing  20  to prevent any disinfectant or antimicrobial agent contained therein from exiting the cavity  28 . 
     The seal  60  may be secured to the engagement surface of open bottom end  23  of housing  20 . The seal  60  minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the cap  10 , provides a leak prevention and protection enclosure, protects the contents of an absorbent material  50  contained within the cavity  40 , and/or maintains a sealed, sterilized environment. The seal  60  provides a sufficient seal at a range of temperatures, pressures, and humidity levels. The seal  60  may be any suitable material such as but not limited to an aluminum or multi-layer polymer film. The seal  60  may be heat-sealed or induction sealed to the open bottom end  23  of the housing  20 . In one or more embodiments, the seal  60  comprises a moisture barrier. In one or more embodiment the seal  60  is peelable. 
     In one or more embodiments the cap  10  includes an absorbent material  50 . The absorbent material  50  may be under radial compression by the inner thread  36  on the inner surface  31  of protrusion  30  to retain the absorbent material  50  in the cavity  40 . In one or more embodiments, the absorbent material  50  is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment the absorbent material  50  is in the form of a foam plug. In one or more embodiments, the absorbent material  50  includes one or more slits. 
     In yet another exemplary implementation, a disinfecting member or members, such as an absorbent material  50 , is in the form of an IPA soaked sponge and/or sponge. In one or more embodiments, absorbent material  50  can also be formed together as a single cleaning member or separate cleaning member can be provided within cavity  28 , for example in the gap  28   a  of cavity  28 . 
     The cap  10  can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the cavity  40  of the cap  10 . The disinfectant or antimicrobial agent can be directly included in the cavity  40  or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fill the cavities of cap  10 . Cap  10  is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel. 
     Compression of the absorbent material  50  toward the top wall  22  of housing  20  upon connection to the female luer connector or the male luer connector allows the connector to contact the disinfectant or antimicrobial agent to disinfect the female luer connector or the male luer connector. 
     Referring further to  FIGS. 5A and 5B , according to exemplary embodiments of the disclosure, cap  10  can receive a tip or hub  82  of a male needleless connector  80 , for example after a seal  60  covering cavity  28  and/or  40  is removed (e.g., wherein the seal  60  is a peel seal) or when the seal  60  is pierced (e.g., wherein the seal  60  is a septum), within cavity  40  and secure the tip or hub  82  of needleless connector  80  within the cavity  40 , by securing, for example, threadedly, a collar  84  of connector  80  within gap  28   a  of cavity  28 . At least a portion of exterior wall  106  of the cap cover  100  is anchored to housing  20 , while the interior wall  104  is free, so that the cap cover  100  is free to deflect downward into gap  28   a  toward top surface  39  upon insertion of a male connector  80 . One or more threads can be sufficient to interlock with a mating feature (such as one or more protrusions, lugs and/or thread) of collar  84  of needleless connector  80 . 
     Referring further to  FIG. 6 , it will be apparent to those skilled in the art based on the present disclosure that the cap  10  can receive a tip or hub  72  of a female needleless connector  70 , for example after a seal  60  sealing cavity  28  and/or  40  is removed or pierced, within cavity  40  and secure, for example, threadedly, the tip of needleless connector  70  within cavity  40 . One or more threads can be sufficient to interlock with a mating feature  74  (such as one or more protrusions, lugs and/or thread) of a hub or tip  72  of needleless connector  70 , as described for example in related U.S. patent application Ser. Nos. 15/408,278 and 15/408,187, both filed on Jan. 17, 2017. In such an embodiment, the cap cover  100  remains undeflected upon coupling of the cap to the female connector  70 . The cap cover  100  covers the gap  28   a  to prevent ingress of contaminants to the gap  28   a.    
     In one or more embodiments the cap cover  100  has sufficient stiffness to be restored to its undeflected position upon removal of the male connector while having sufficient flexibility to deflect. 
     Now referring to  FIGS. 8-11 , various embodiments of cap covers are disclosed. With reference to  FIGS. 8-9 , in one exemplary embodiment a cap  10  includes a cap cover  200  including an annular body  202 , which includes an interior wall  204  defining an opening  214  in the annular body  202 , an exterior wall  206 , a top surface  208  and an opposing bottom surface  210 . 
     Now referring to  FIGS. 10-11 , in a further exemplary embodiment a cap  10  includes a cap cover  300  including an annular body  302 , which includes an interior wall  304  defining an opening  314  in the annular body  302 , an exterior wall  306 , a top surface  308 , an opposing bottom surface  310  and a plurality of slits  312  formed in the annular body  302  to facilitate deflection of the cap cover  300  into the gap  28   a.    
     The cap covers  200  and  300  may be positioned in the cap  10  in the same way as described hereinabove with reference to cap cover  100 . In some cases it may be more desirable to directly couple the exterior wall  206  or  306  to the inner surface  21  of the sidewall  26  proximal the bottom end  23  of the housing than to directly couple the cap cover interior wall  204  or  304  to the protrusion outer surface  33  or end  37 . 
     The cap covers  100 ,  200  and  300  disclosed herein may be used in conjunction with any cap having a housing and protrusion in which a gap is formed therebetween. Such caps include but are not limited to those described in U.S. patent application Ser. No. 16/261,761 filed Jan. 30, 2019, the entirety of which is incorporated by reference herein. 
     In an exemplary implementation of  FIGS. 1-4 , protrusion  30  is illustrated as comprising two prongs  30   a  spaced by cutouts  35  and extending essentially from surface  25  of top wall  22 . However, also within the scope of the disclosure are caps  10  including a unitary protrusion  30  without any cutouts  35 , and caps having a protrusion  30  including any number of identical and/or different (in any dimensional characteristics, such as length width, thickness, or shape) prongs  30   a , as long as protrusion  30  is configure to engage a female connector with respect to its inner surface, and engage a male connector with respect to its outer surface. 
     Referring to  FIG. 3 , in one or more embodiments, the exterior surface of sidewall  26  may include a plurality of grip members  90 . 
     The cap  10  may be made from any suitable material including but not limited to a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices. In one or more embodiments, the cap  10  includes a polypropylene or polyethylene material. 
     According to exemplary implementations of the embodiments of the disclosure, cap  10  described above can further include an outer housing implementing the safety features and designs described in U.S. patent applications No. 62/488,266 filed Apr. 21, 2017 and No. 62/523,506, filed Jun. 22, 2017, for example by modifying walls  22  and/or  26  of housing  20 . 
     According to yet further exemplary implementations of the embodiments of the disclosure, cap  10  described above can be implemented with various venting features and designs described in U.S. patent application Ser. Nos. 15/408,278 and 15/408,187, both filed on Jan. 17, 2017, for example by modifying shape and/or size of protrusion  30 , and/or configuration (such as pitch, spacing, thickness, and/or other structural features) of thread  36  and/or thread  38 , and/or configuration of surface  31  and/or surface  33 . 
     In another aspect the presently disclosed subject matter relates to an assembly. The assembly includes the cap of one or more embodiments described herein connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and needleless connector. 
     While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the embodiments of the present disclosure. For example, a disinfection sponge can comprise any suitable disinfecting or other application-specific substance, and can be made of any suitable material. Also, the inner and/or the outer housing of the cap can be single shot molded, or made by other suitable process. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the spirit and scope of the embodiments of the present disclosure. 
     In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans skilled in the relevant field of invention. 
     Other objects, advantages and salient features of the disclosure will become apparent to those skilled in the art from the details provided, which, taken in conjunction with the annexed drawing figures, disclose exemplary embodiments of the disclosure. 
     Reference throughout this specification to “one embodiment,” “certain embodiments,” “one or more embodiments” or “an embodiment” means that a particular feature, structure, material, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Thus, the appearances of the phrases such as “in one or more embodiments,” “in certain embodiments,” “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily referring to the same embodiment of the disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments. 
     Although the disclosure herein has provided a description 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 method and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.