Universal Disinfection Cap

Abstract

An antiseptic cap is described that includes a housing, a protrusion, and a cap cover, wherein the housing includes a top wall, an essentially cylindrical side wall that forms a first cavity, and an open bottom end opposite the top wall formed by the cylindrical side wall having 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 disposed within the first cavity and includes an inner surface, an outer surface, and an end distal to the top wall of the housing, the inner surface of the protrusion defines a second cavity, and the outer surface of the protrusion and the essentially cylindrical side wall define a gap therebetween, and the cap cover is sized 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.

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. In general, exemplary embodiments of the present disclosure relate to the field of threaded fittings, including medical caps and medical antiseptic caps, particularly caps with bars and / or antiseptic caps for use with fluid Luer connectors. [Background technology]

[0002] Vascular access devices (VADs) are common therapeutic 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 and ports / valves upon connection to a VAD for fluid or medication delivery. Each access hub (or port / valve or connection) carries some risk of transmitting a catheter-related bloodstream infection (CRBSI), which can be costly and potentially fatal.

[0003] In developed markets, needleless connectors are typically used when accessing IV catheters to close the system and then administer medications or other necessary fluids to the patient via the catheter. INS practice standards recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected with alcohol, iodine tincture, or a chlorhexidine gluconate / alcohol combination before each access." Disinfection of needleless connectors ultimately aims to help reduce bacteria that may inhabit surfaces and cause various catheter-related complications, including CRBSI. Nurses typically complete the disinfection process using a 70% isopropyl alcohol (IPA) pad, a process known as "hub scrubbing." However, adherence to this practice is generally very low. In addition to a lack of adherence to "hub scrubbing," interviews with clinicians also noted frequent variability in scrubbing times, drying times, and frequency of scrubbing needleless connectors.

[0004] There are many risks of contact or contamination throughout the sequence of steps associated with transmission of microorganisms that can cause CRBSI. Contamination can occur during mixing of medications, attachment of the cannula, and insertion into the access hub. Because connecting to a VAD is so common and simple, the risks associated with entering the patient's vascular system have often been overlooked. Currently, the risk to the hospital and the patient depends largely on the diligence of the clinician making the connection, and this diligence is largely uncontrollable. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent Application Serial No. 16 / 261,761 [Patent Document 2] U.S. Patent Application No. 15 / 408,278 [Patent Document 3] U.S. Patent Application No. 15 / 408,187 [Patent Document 4] U.S. Patent Application No. 62 / 488,266 [Patent Document 5] U.S. Patent Application No. 62 / 523,506 Summary of the Invention [Problem to be solved by the invention]

[0006] To reduce the incidence of CRBSI and ensure proper use and maintenance of VADs, standards of practice, including disinfection and cleaning procedures, have been developed. Antiseptic 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 the introduction of microorganisms and / or other contaminants. Therefore, cap covers are needed to protect the antiseptic caps from the introduction of microorganisms and / or other contaminants. [Means for solving the problem]

[0007] A first aspect of the present disclosure relates to a cap including a housing, a protrusion, and a cap cover.

[0008] The housing may include a top wall, an essentially cylindrical side wall forming a first cavity, and an open bottom end opposite the top wall formed by the cylindrical side wall with an opening to the first cavity within the housing for receiving the hub of the female or male needleless connector. The protrusion is disposed within the first cavity and may be integrally formed with the housing or may be a removable insert. The protrusion may include a side wall having an inner surface and an outer surface, the inner surface of the protrusion defining the second cavity and the outer surface facing the inner surface of the essentially cylindrical side wall of the housing. An internal thread is included on the inner surface of the protrusion, sufficient to interlock with a mating portion of the female needleless connector. An external thread is included on the outer surface of the protrusion, sufficient to interlock with a mating portion of the male needleless connector. In one or more embodiments, the protrusion side wall includes at least one gap. The side wall may define one or more prongs separated by one or more respective gaps. In one or more embodiments, at least one protrusion can be curved to facilitate an interference fit between the protrusion and a mating portion of the male or female needleless connector. In one or more embodiments, the protrusion can extend essentially from the inner surface of the top wall toward the bottom of the opposite side of the housing. In one or more embodiments, the protrusion can extend essentially parallel to the side wall of the housing. The outer surface of the protrusion and the inner surface of the housing define a gap therebetween, and the gap can be essentially annular.

[0009] The cap cover is sized 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 of any suitable shape, such as, but not limited to, annular, and includes a top surface, an opposing bottom surface, an outer wall, and an inner wall defining an opening. The cap cover is positioned between the inner surface of the essentially cylindrical sidewall proximate the open bottom end of the housing and the outer surface of the protrusion, covering at least a portion of the annular gap. In one embodiment, at least a portion of the outer wall of the cap cover is coupled or directly coupled to the inner surface of the housing, and the inner wall of the cap cover is positioned proximate to, adjacent to, directly adjacent to, or abutting the protrusion. The inner wall of the cap cover may extend to or beyond the end of the protrusion. In other embodiments, at least a portion of the inner wall is coupled or directly coupled to the end of the protrusion and / or the outer surface, and the outer wall of the cap cover is positioned proximate to, adjacent to, directly adjacent to, or abutting 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 the male connector into the cap.

[0010] The cap cover may be formed from a resilient material, such as, but not limited to, a polymeric or elastomeric material. The cap cover is flexible enough to deflect when the male connector is attached to the cap. When the male connector is removed from the cap, the cap cover returns to its original position. When the female connector is used, the gap remains covered by the cap cover, preventing materials such as sand, saliva, and the like from entering the cap and contaminating it and / or creating an obstruction that could prevent the cap from being mated to the connector.

[0011] The cap cover may form part of the housing through two-shot molding or may be attached to the housing through lamination, welding, hot glue, adhesive, or other bonding methods.

[0012] The cap cover may be made of any suitable material, such as, but not limited to, a polymer, an 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.

[0013] In embodiments in which the protrusion is or includes a removable insert disposed within the first cavity, the removable insert can include a distal end including 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-threaded protrusion integrally formed with the distal wall, the split-threaded protrusion having an inner surface and an outer surface. The inner surface of the split-threaded protrusion defines the second cavity. An internal thread is included on the inner surface of the split-threaded protrusion, the internal thread being sufficient to interlock with a mating portion of a female needleless connector. An external thread is included on the outer surface of the split-threaded protrusion, the external thread being sufficient to interlock with a mating portion of a male needleless connector.

[0014] In one or more embodiments, the split screw protrusion includes one or more cantilevered protrusions separated by one or more respective gaps, and at least one of the protrusions is configured to flex to facilitate an interference fit between the protrusion and a mating portion of the male needleless connector or the female needleless connector.

[0015] 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 slope outward toward the distal wall, and the lower portion of the sidewall can be cylindrical.

[0016] According to one or more embodiments, the protrusion includes an absorbent material including an antiseptic or antibacterial agent disposed in the second cavity. In one or more embodiments, the antiseptic or antibacterial agent disinfects the exterior and interior surfaces of the female or male needleless connector when a portion of the female or male needleless connector is inserted into the second cavity.

[0017] According to yet a further embodiment, the cap includes a septum coupled to the open bottom end of the housing, thereby forming a seal for maintaining the antiseptic or antimicrobial agent within the second cavity prior to use of the cap.

[0018] 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.

[0019] In one or more embodiments, the absorbent material can be a nonwoven or woven material. In one or more embodiments, the absorbent material can be a foam or sponge. In one embodiment, the foam can be polyurethane foam. In one or more embodiments, the absorbent material can include slits. In one or more embodiments, compression of the absorbent material toward the upper wall of the housing occurs upon connection to the female needleless connector, whereby compression of the absorbent material sterilizes the female needleless connector. In one or more embodiments, the absorbent material can be subjected to radial compression by the internal threads of the inner surface of the split screw protrusion to retain the absorbent material within the second cavity.

[0020] In one or more embodiments, the exterior wall surface of the sidewall of the housing can include a plurality of gripping members.

[0021] In one or more embodiments, when the hub of the female needleless connector is received in the second cavity, the hub is secured within the second cavity by interlocking at least a portion of the internal threads with a mating portion on the hub of the female needleless connector, and the cap cover remains unbent. In one or more embodiments, when the hub of the male needleless connector is received in the second cavity, the cap cover is deflected toward the housing top wall when the collar of the male needleless connector is received in the gap formed between the protrusion outer wall and the inner surface of the housing side wall, and the hub is secured within the first cavity by interlocking at least a portion of the external threads on the outer surface of the protrusion with a mating portion on the collar of the male needleless connector.

[0022] 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 outer wall of the protrusion and the inner surface of the housing side wall. In one or more embodiments, the profile of the internal threads can essentially correspond to or match the profile of the external threads.

[0023] In one or more embodiments, the internal and external threads can include an oblique thread pattern. In one or more embodiments, the internal and external threads can include a helical thread pattern. In one or more embodiments, the internal or external threads can include one or more gaps in the thread pattern.

[0024] In one or more embodiments, the inner surface of the protrusion can be essentially parallel to the outer surface of the protrusion.

[0025] In one or more embodiments, the antiseptic or antibacterial 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, 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 one or more specific embodiments, the antiseptic or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0026] In yet a further embodiment, an assembly is disclosed that includes 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 a needleless connector.

[0027] 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.

[0028] 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]

[0029] Disclosed Disinfection Cap To assist those skilled in the art in making and using the present invention, reference is made to the accompanying drawings. [Figure 1] FIG. 1 is an elevated perspective view of an antiseptic cap having a cap cover according to one or more embodiments disclosed herein. [Figure 2] 2 is a cross-sectional view of the antiseptic cap of FIG. 1 taken along line A-A' according to one or more embodiments disclosed herein. [Figure 3] FIG. 1 is a transparent elevated perspective view of an antiseptic cap having a cap cover according to one or more embodiments disclosed herein. [Figure 4] FIG. 2 is an elevated perspective view of a cap cover according to an exemplary embodiment of the present disclosure. [Figure 5A] FIG. 1 is an elevated perspective view of an antiseptic cap including an absorbent material according to one or more embodiments disclosed herein. [Figure 5B] FIG. 5B is a cross-sectional view of the antiseptic cap of FIG. 5A taken along line B-B' according to one or more embodiments disclosed herein. [Figure 6] FIG. 5B is a side partial cross-sectional view showing the antiseptic cap of FIG. 5A (cross-section view) coupled to a male connector (shown in side view) according to one or more embodiments disclosed herein. [Figure 7] FIG. 5C is a side partial cross-sectional view showing the antiseptic cap of FIG. 5B (cross-section view) coupled to a female connector (shown in side view) according to one or more embodiments disclosed herein. [Figure 8] FIG. 1 is an elevated perspective view of an antiseptic cap having a cap cover according to one or more embodiments disclosed herein. [Figure 9] FIG. 2 is an elevated perspective view of a cap cover according to an exemplary embodiment of the present disclosure. [Figure 10] FIG. 1 is an elevated perspective view of an antiseptic cap having a cap cover according to one or more embodiments disclosed herein. [Figure 11]FIG. 2 is an elevated perspective view of a cap cover according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0030] 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.

[0031] The following definitions are provided for terms used in this disclosure.

[0032] As used herein, the use of "a," "an," and "the" includes the singular and plural.

[0033] As used herein, the term "catheter-related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or intravenous line.

[0034] As used herein, the term "Luer connector" refers to a connecting tube that is a standard method for attaching syringes, catheters, hubbed needles, IV tubing, and the like. Luer connectors consist of interlocking male and female tubing, slightly tapered to allow for a secure connection with a simple press / twist fit. Luer connectors can optionally include an outer periphery of threads for added security. The male end of a Luer connector is typically associated with a flush syringe and can interlock and connect to a female end located on a vascular access device (VAD). Luer connectors consist of a distal end, a proximal end, an irregularly shaped outer wall, and a profiled 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 detachably attaches to the hub of the VAD and a proximal end channel that detachably attaches to the syringe barrel.

[0035] As will be readily understood by one of ordinary skill in the relevant art, terms such as "bond," "hole," "tip," "hub," "screw," "sponge," "projection," "protrusion," "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.

[0036] When an element is referred to as being "coupled" or "connected" to another element, it will be understood that it may be directly coupled or connected to the other element, or that 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. When an element is referred to as being "adjacent" to another element, it will be understood that it may be directly adjacent to the other element, or that 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.

[0037] 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.

[0038] 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.

[0039] An embodiment of the present disclosure relates to a universal cap for connecting to and disinfecting medical connectors, including male and female connectors, the universal cap having a cap cover positioned and dimensioned to prevent microbial ingress, debris, and / or other contamination from entering the cap. The male and female connectors may be male and female Luer connectors. An embodiment of the cap includes a housing and a protrusion. The housing includes a sidewall, a closed end, and an opposite open end. The housing sidewall 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, may extend from the closed end and be concentrically formed within the housing. The outer wall of the protrusion and the inner surface of the housing sidewall define a gap therebetween. The cap cover is configured and arranged to cover at least a portion of the gap formed between the outer wall of the protrusion and the inner surface of the housing sidewall. In one or more embodiments, the bottom open end includes a peripheral shelf extending radially outward from an open surface defining an end face and an engagement surface. The protrusion has an inner wall surface with one or more threads adapted to engage a female Luer connector. The protrusion's outer wall surface includes one or more threads sized and adapted to receive a male Luer connector. The cap can further include an absorbent material, a disinfectant or antibacterial agent, and a peelable seal and / or septum. The cap provides a mechanical barrier for the connector and includes an antibacterial agent for disinfection.

[0040] Exemplary embodiments of the present disclosure provide a cap that can approximately halve the number of equipment types and logistics currently required in a hospital environment to connect, cap, and / or disinfect male and female threaded fluid luer connectors by including functionality for use with both male and female threaded fittings in a single cap or device.

[0041] In exemplary implementations of embodiments of the present disclosure, the cap, connection cap, or antiseptic cap includes integrated threads or multiple threads and other features in any and all combinations that allow it to mate with both male and female threaded fittings.

[0042] According to a further exemplary implementation of an embodiment of the present disclosure, the configuration of the structural elements that make up the cap includes one or more cantilevered protrusions disposed in an internal cavity of the cap, the cantilevered protrusions including internal threads for connecting to a female medical connector and external threads for connecting to a male medical connector to facilitate securing the cap to a female or male fitting, respectively.

[0043] 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 protrusion.

[0044] According to yet another exemplary implementation of an embodiment of the present disclosure, the cantilevered protrusion may be in the form of a protrusion and may be of a split thread type, which protrusion may be bent to allow for a better interference fit with the fitting.

[0045] 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.

[0046] In one or more embodiments, the female connector can 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.

[0047] In one or more embodiments, the male connector can be an intravenous tubing end, a stopcock, or a male locking luer.

[0048] 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.

[0049] A first aspect of the present disclosure relates to a cap 10 including a housing 20, a protrusion 30, and a cap cover 100. Referring to Figures 1-4, the housing 20 may 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 the hub of a female or male needleless connector. In one embodiment, the protrusion 30 is integrally formed with the housing 20 and disposed within the first cavity 28. The protrusion 30 includes a sidewall 32 including an inner surface 31 and an outer surface 33, the inner surface 31 of the protrusion 30 defining a second cavity 40, and an end 37 distal from the top wall 22.

[0050] In one or more embodiments, the cap 10 of the present disclosure has internal threads 36 sized and pitched to mate with the threaded portion of a female connector, such as 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, the cap 10 provides a protective cover for the female Luer connector when the threads of the female Luer connector engage with the internal threads 36 of the cap 10 to form a detachable connection. The internal threads 36 are included on the inner surface 31 of the protrusion 30 and are sufficient to mate with a mating portion of a female needleless connector. The external threads 38 are included on the outer surface 33 of the protrusion 30 and are sufficient to mate with a mating portion of a male needleless connector. In one or more embodiments, the protrusion 30 includes one or more cantilevered protrusions, each separated by one or more gaps. In one or more embodiments, at least one protrusion 30 a can be bent to facilitate an interference fit between the protrusion 30 and a mating portion of a male or female needleless connector. In one or more embodiments, the protrusion 30 may extend essentially from the 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 may extend essentially axially aligned with the side wall 26 of the housing 20.

[0051] In an exemplary implementation of an embodiment of the present disclosure, the protrusion 30 can be cantilevered, for example, by having one or more gaps or notches 35. In an exemplary implementation, at least a portion of the cantilevered protrusion 30 can bend, which allows for a better interference fit with a fitting, such as at least one of a male connector or a female connector.

[0052] In yet another exemplary implementation, the protrusion 30 may extend essentially parallel to the sidewall 26 .

[0053] In yet another exemplary embodiment, cavity 40 can extend further into cap 10 toward inner surface 25 of top wall 22 than the portion of first cavity 28 defined by gap 28a that terminates at top surface 39.

[0054] In yet another exemplary implementation, the profile of the internal threads 36 and / or the inner surface 31 can essentially correspond or match the shape of the external threads 38 and / or the outer surface 33, respectively.

[0055] The outer surface 33 of the protrusion 30 and the inner surface 21 of the housing 20 define a gap 28a therebetween. The gap 28a may be annular. The cap cover 100 is disposed between the inner surface 21 of the essentially cylindrical sidewall 26 proximate the bottom end 23 of the housing and the protrusion outer surface 33, covering at least a portion of the annular gap 28a. The cap cover 100 includes an annular body 102 including an inner wall 104, an outer wall 106, a top surface 108, and an opposing bottom surface 110, which define an opening 114 within the annular body 102. The thickness and composition of the cap cover 100 are optimally suited to provide the most adequate coverage of the gap 28a and allow sufficient flexion of the cap cover 100 when used with a male connector. In one embodiment, at least a portion of the outer wall 106 of the cap cover 100 is coupled or directly coupled to the inner surface 21 of the housing, and the cap cover inner wall 104 is disposed proximate to, adjacent to, directly adjacent to, or abutting the protrusion outer surface 33. The cap cover inner wall 104 may extend to or over the end 37 of the protrusion. In other embodiments, at least a portion of the inner wall 104 is coupled or directly coupled to the protrusion end 37 and / or the outer surface 33. In other embodiments, at least a portion of the inner wall 104 is coupled or directly coupled to the protrusion end 37 and / or the outer surface 33, and the cap cover outer wall 106 is disposed proximate to, adjacent to, directly adjacent to, or abutting the inner surface 21 of the housing 20.

[0056] In at least one embodiment, the cap cover 100 includes a tab 112 that extends into the opening 114. The tab 112 may be configured and oriented to cover the opening formed by the gap 35 in the protrusion 30.

[0057] In one or more embodiments, a seal 60 in the form of a peel seal or septum may be provided to seal the opening 27 prior to use of the cap 10, for example, by attaching it to a surface of the rim 29 of the open bottom 23 of the housing 20, as described in U.S. Patent Application Publication No. 2019 / 0139994, filed January 30, 2019, which is incorporated herein by reference in its entirety. In one or more embodiments, the seal 60 may be disposed over the open bottom 23 of the housing 20 to prevent any antiseptic or antimicrobial agent contained therein from escaping the cavity 28.

[0058] The seal 60 may be secured to a mating surface of the open bottom end 23 of the housing 20. The peelable seal 60 minimizes the intrusion of potential particulate contaminants, provides a substantially impermeable enclosure for the cap 10, provides a leak-proof and protective enclosure, protects the contents of the absorbent material 50 contained within the cavity 40, and / or maintains a sealed, sterile environment. The peelable seal 60 provides a sufficient seal over a range of temperatures, pressures, and humidity levels. The seal 60 may be any suitable material, such as, but not limited to, aluminum or a multilayer 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 includes a moisture barrier. In one or more embodiments, the seal 60 is peelable.

[0059] In one or more embodiments, cap 10 includes absorbent material 50. Absorbent material 50 may be radially compressed by internal threads 36 on inner surface 31 of protrusion 30 to retain absorbent material 50 within cavity 40. In one or more embodiments, absorbent material 50 is a nonwoven material, a foam, or a sponge. In certain embodiments, the foam is polyurethane foam. In certain embodiments, absorbent material 50 is in the form of a foam plug. In one or more embodiments, absorbent material 50 includes one or more slits.

[0060] In yet another exemplary embodiment, the sanitizing member or members, such as absorbent material 50, are in the form of an IPA soaked sponge and / or sponges. In one or more embodiments, absorbent material 50 may also be formed together as a single cleaning member or as separate cleaning members that may be provided within cavity 28, for example, within interstices 28a of cavity 28.

[0061] The cap 10 can be disinfected when used with a luer connector by incorporating a disinfectant or antimicrobial agent into the cavity 40 of the cap 10. The disinfectant or antimicrobial agent can be contained directly in the cavity 40, or the disinfectant or antimicrobial agent can be absorbed into a sponge or foam material that fills the cavity of the cap 10. The cap 10 is designed to accommodate interaction with a variety of disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent can include various alcohols or chlorhexidine. In one or more embodiments, the disinfectant or antibacterial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In certain embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antibacterial agent is a fluid or gel.

[0062] Compression of the absorbent material 50 towards the top wall 22 of the housing 20 upon connection to the female or male luer connector allows the connector to come into contact with the disinfectant or antimicrobial agent to disinfect the female or male luer connector.

[0063] 5A and 5B , according to an exemplary embodiment of the present disclosure, the cap 10 can receive the tip or hub 82 of the male needleless connector 80 within the cavity 40, for example, after the seal 60 covering the cavities 28 and / or 40 has been removed (e.g., the seal 60 is a peel seal) or when the seal 60 has been pierced (e.g., the seal 60 is a septum), and the tip or hub 82 of the needleless connector 80 can be secured within the cavity 40 by, for example, threading the collar 84 of the connector 80 into the gap 28a of the cavity 28. At least a portion of the outer wall 106 of the cap cover 100 is secured to the housing 20, while the inner wall 104 is free, such that the cap cover 100 can freely deflect downward toward the upper surface 39 within the gap 28a upon insertion of the male connector 80. The one or more threads can be sufficient to interlock with a mating portion (e.g., one or more protrusions, lugs, and / or screws) of the collar 84 of the needleless connector 80.

[0064] 6 , it will be apparent to those skilled in the art based on this disclosure that the cap 10 can receive the tip or hub 72 of the female needleless connector 70 within the cavity 40, for example, after the seal 60 and / or sealing cavities 28 and / or 40 have been removed or pierced, and secure the tip of the needleless connector 70 within the cavity 40 with a threaded fastening. The threads can be sufficient to interlock with a mating portion 74 (e.g., one or more protrusions, lugs, and / or screws) of the hub or tip 72 of the needleless connector 70, for example, as described in related U.S. Patent Application Publication Nos. 2003 / 0129994 and 2003 / 0129999, filed January 17, 2017. In such an embodiment, the cap cover 100 remains rigid when the cap is coupled to the female connector 70. The cap cover 100 covers the gap 28a to prevent the ingress of contaminants into the gap 28a.

[0065] In one or more embodiments, the cap cover 100 is flexible enough to deflect while being rigid enough to return to its undeflected position upon removal of the male connector.

[0066] 8-11, various embodiments of cap covers are disclosed. Referring to Figures 8-9, in one exemplary embodiment, the cap 10 includes a cap cover 200 that includes an annular body 202, which includes an inner wall 204, an outer wall 206, a top surface 208, and an opposing bottom surface 210 that define an opening 214 within the annular body 202.

[0067] 10-11 , in a further exemplary embodiment, cap 10 includes a cap cover 300 including an annular body 302 including an inner wall 304 defining an opening 314 in annular body 302, an outer wall 306, a top surface 308, an opposing bottom surface 310, and a plurality of slits 312 formed in annular body 302 to facilitate deflection of cap cover 300 into gap 28a.

[0068] Cap covers 200 and 300 may be positioned within cap 10 in the same manner as described above with reference to cap cover 100. In some cases, it may be desirable to directly bond outer wall 206 or 306 to inner surface 21 of side wall 26 adjacent bottom end 23 of the housing, rather than directly bonding cap cover inner wall 204 or 304 to protrusion outer surface 33 or end 37.

[0069] The cap covers 100, 200, and 300 disclosed herein can be used in conjunction with any gap having a housing and a protrusion that forms a gap therebetween, including, but not limited to, those described in U.S. Patent Application Publication No. 2019 / 0129999, filed January 30, 2019, the entire contents of which are incorporated herein by reference.

[0070] 1-4, protrusion 30 is shown as comprising two projections 30a spaced apart by a notch 35 and extending essentially from surface 25 of top wall 22. However, within the scope of the present disclosure, caps may include a single protrusion 30 without a notch 35, or a cap having any number of identical and / or different protrusions 30 (in any dimensional characteristic, such as length, width, thickness, or shape), so long as protrusion 30 is configured to engage a female connector with respect to its inner surface and to engage a male connector with respect to its outer surface.

[0071] Referring to FIG. 3, in one or more embodiments, the exterior surface of sidewall 26 may include a plurality of gripping members 90 .

[0072] Cap 10 can be made from any suitable material, including several types of plastic materials, such as, but not limited to, polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactic acid, acrylonitrile butadiene styrene, or other moldable plastic materials used in medical devices. In one or more embodiments, cap 10 comprises a polypropylene or polyethylene material.

[0073] According to an exemplary implementation of the disclosed embodiments, the cap 10 described above may further include an outer housing that implements the safety features and structures described in U.S. Patent Application Publication No. 2017 / 0129999, filed April 21, 2017, and U.S. Patent Application Publication No. 2017 / 0129999, filed June 22, 2017, for example, by modifying wall 22 and / or wall 26 of housing 20.

[0074] According to yet another exemplary implementation of the presently disclosed embodiments, the above-described cap 10 can be provided with various ventilation functions and structures as described in U.S. Patent Application Publication No. 2017 / 0129999 and U.S. Patent Application Publication No. 2017 / 0129999, filed January 17, 2017, for example, by modifying the shape and / or size of protrusion 30, and / or the arrangement (such as pitch, spacing, thickness, and / or other structural features) of threads 36 and / or threads 38, and / or the arrangement of surfaces 31 and / or surfaces 33.

[0075] In another aspect, the presently disclosed subject matter relates to an assembly comprising one or more embodiments of the cap described herein 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.

[0076] 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-shot 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.

[0077] Additionally, the accompanying drawings further illustrate non-limiting examples of certain exemplary embodiments of the present disclosure and aid in explaining the technology associated therewith. Specific or relative dimensions or measurements shown in the above drawings and 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.

[0078] Other objects, advantages and salient features of the present disclosure will become apparent to those skilled in the art from the detailed disclosure of illustrative embodiments thereof taken in conjunction with the accompanying drawings.

[0079] 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.

[0080] 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 disinfection cap including a housing, a protrusion, and a cap cover, the housing includes a top wall, a cylindrical side wall forming a first cavity, and an open bottom end opposite the top wall formed by the cylindrical side wall having an opening to the first cavity within the housing for receiving a hub of a female or male needleless connector; the protrusion is disposed within the first cavity and includes an inner surface, an outer surface, and an end distal to the top wall of the housing; an inner surface of the protrusion defining a second cavity; an outer surface of the protrusion and the cylindrical sidewall defining a gap therebetween; the cap cover is sized and positioned to cover at least a portion of the gap between an outer surface of the protrusion and an inner surface of the housing; the cap cover includes a body including a top surface, an opposing bottom surface, an outer wall, and an inner wall defining an opening; A disinfection cap, wherein at least a portion of the outer wall of the cap cover is connected to or directly connected to the inner surface of the housing so that the cap cover is free to deflect downward into a gap between the outer surface of the protrusion and the inner surface of the housing when a male connector is inserted into the disinfection cap, and the inner wall of the cap cover is positioned proximate to, adjacent to, directly adjacent to, or abutting the outer surface of the protrusion.

2. The antiseptic cap of claim 1 , wherein the cap cover is annular.

3. The antiseptic cap of claim 1 , wherein the cap cover includes at least one slit formed in a body of the cap cover.

4. The antiseptic cap of claim 1 , wherein the cap cover is disposed between the inner surface of the cylindrical side wall adjacent the open bottom end of the housing and the protrusion.

5. The antiseptic cap of claim 1 , wherein the inner wall of the cap cover extends to or beyond the end of the protrusion.

6. 2. The antiseptic cap of claim 1, wherein at least a portion of the inner wall is connected or directly connected to the outer surface of the protrusion and / or the end of the protrusion so that the cap cover is free to deflect downward into a gap between the outer surface of the protrusion and the inner surface of the housing when a male connector is inserted into the antiseptic cap, and the outer wall of the cap cover is positioned proximal to, adjacent to, directly adjacent to, or abutting the inner surface of the housing.

7. 2. The antiseptic cap of claim 1, wherein the cap cover includes at least one tab extending into the opening, the at least one tab configured and oriented to cover at least one gap of the protrusion.

8. The antiseptic cap of claim 1 , further comprising a seal disposed on the open bottom end of the housing.

9. The antiseptic cap of claim 1 , further comprising an absorbent material disposed within the housing.

10. 10. The antiseptic cap of claim 9, wherein the absorbent material is disposed within the second cavity and includes an antiseptic or antibacterial agent.

11. The antiseptic cap of claim 10, wherein the antiseptic or antibacterial agent is alcohol or chlorhexidine.

12. 11. The antiseptic cap of claim 10, wherein the antiseptic or antibacterial 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.

13. 13. The antiseptic cap of claim 12, wherein the antiseptic or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

14. The antiseptic cap of claim 1 , wherein the cap cover comprises an elastic material.

15. The antiseptic cap of claim 1 , wherein the cap cover is integral with the housing.

16. The antiseptic cap according to claim 1, wherein the thickness of the cap cover is 0.1 mm to 3 mm.

17. The antiseptic cap according to claim 1, wherein the thickness of the cap cover is 0.1 mm to 2 mm.

18. The antiseptic cap of claim 1 , including internal threads on the inner surface of the protrusion, the internal threads interlocking with a mating portion of a female needleless connector.

19. The antiseptic cap of claim 1 , comprising external threads on the outer surface of the protrusion, the external threads interlocking with a mating portion of a male needleless connector.

20. The antiseptic cap of claim 1 , wherein the protrusion includes a sidewall including at least one gap and at least one protrusion.

21. The antiseptic cap of claim 1 , wherein the protrusion is integral with the housing.

22. 2. The antiseptic cap of claim 1, wherein the protrusion includes a removable insert disposed in the first cavity, the removable insert including a distal end including a distal wall, an open proximal end, and a sidewall extending proximally from the distal wall toward the open proximal end.

23. 10. An assembly comprising the antiseptic cap of claim 1 and coupled to a medical connector.

24. 24. The assembly of claim 23, wherein the medical connector is selected from a male luer connector, a female luer connector, and a needleless connector.

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