Disinfection Cap

Abstract

A disinfection cap for connecting to a medical connector is described, the disinfection cap including a housing having a top wall and a side wall forming a cavity, a disinfectant or antibacterial agent, and a ball disposed within the cavity. The outer surface of the housing includes threads sufficient to mate with mating features of a threaded connector, more specifically, a male Luer connector. The cap may include a peelable seal to prevent the disinfectant or antibacterial agent from escaping the cavity. The cap cavity may include one or more ribs disposed on the inner surface of the cavity to retain the ball within the cavity, and may also form a flow path when the ball is further pressed within the cavity. The outer sidewall surface of the housing may include a plurality of gripping members.

Description

[Technical field]

[0001] The present disclosure relates to a disinfection cap device for disinfecting a corresponding medical connector. The present disclosure generally relates to a device for disinfecting and sterilizing an access port of a medical connector having a fitting. In general, exemplary embodiments of the present disclosure relate to the field of threaded or mating fittings, including medical caps and medical disinfection caps, and in particular to caps and / or disinfection caps for use with threaded fluid connectors. An exemplary embodiment of the present disclosure relates to a male disinfection cap device for disinfecting a male threaded Luer connector. [Background technology]

[0002] background Vascular access devices (VADs) are commonly used 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 the patient's vascular system through the access hub, port, or valve when connected to a ventricular assist device to deliver fluids and medicines. Each access hub, port, valve, or connection poses the risk of catheter-related bloodstream infection (CRBSI), which is not only costly but can also be fatal. To reduce CRBSI and ensure the correct use and maintenance of VADs, codes of practice have been developed that include disinfection and cleaning procedures. Disinfectant caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and the Infusion Nurse Standards (INS) guidelines.

[0003] In developed markets, when utilizing IV catheters, needleless connectors are typically used to close the system and then access the catheter to administer medications or other necessary fluids to the patient. The INS practice standards recommend the use of needleless connectors and state that they should be "consistently and thoroughly disinfected with a combination of alcohol, tincture of iodine, and chlorohexidine gluconate / alcohol before each access." Disinfection of needleless connectors ultimately aims to reduce bacteria that may live on surfaces and cause various catheter-related complications, including CRBSI. Nurses typically complete this disinfection task with a so-called "hub scrub" using a 70% isopropyl alcohol (IPA) pad. However, compliance with this practice is generally very low. In addition to the lack of compliance with hub scrubbing, it was also noted through practitioner interviews that there is often variability in scrubbing time, drying time, and the number of times needleless connectors are scrubbed. Summary of the Invention [Problem to be solved by the invention]

[0004] There is an increasing need to protect male connectors to reduce CLABSIs and PLABSIs. Threaded male Luer connections on IV gravity sets and syringes are subject to contamination if not properly protected. Currently, when disconnecting an IV connector from a central or peripheral line to temporarily stop an infusion, nurses often tie the male connector to a needleless connector at the Y-site or wrap the male connector with an isopropyl alcohol (IPA) / alcohol-impregnated wipe or cloth. However, such protection is very weak and does not adequately protect the Luer from contact contamination. Male disinfection caps have become the state-of-the-art disinfection and protection device to disinfect male connectors and form a physical barrier to prevent microbial growth.

[0005] There are many risks of contact or contamination throughout the sequence of procedures related to the transmission of microorganisms that can cause CRBSI. As an example, contamination can occur during mixing of medications, attachment of the cannula, and insertion into the access hub. Additionally, threaded male connectors have open lures and exposed lumens. Because the procedure of connecting to an artificial heart 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 is substantially correlated to the diligence of the practitioner making the connection, and this diligence is largely uncontrollable.

[0006] Disinfectants generally have a threshold limit for systemic exposure for injection into the bloodstream due to the biotoxicity of the disinfectant at high doses. Thus, there is a need for a disinfection device that can block the lumen of an open luer to facilitate mitigation of ingress of such disinfectants into the connector, thereby reducing the risk of the disinfectant entering the bloodstream. There is a need for a mechanism that prevents the disinfectant from entering the lumen and fluid pathway while providing effective disinfection of the surrounding connector or fitting. [Means for solving the problem]

[0007] overview A first aspect of the present disclosure relates to a cap including a housing, a ball, a disinfectant or antimicrobial agent, and a removable seal. The housing can include a top wall, an essentially cylindrical sidewall having an outer surface and an inner surface forming a cavity, and an open bottom formed by the cylindrical sidewall having an opening to the cavity within the housing for receiving the hub of a male luer connector.

[0008] In one or more embodiments, an upper portion of the housing's sidewall tapers outwardly toward the top wall, and a lower portion of the sidewall is cylindrical.

[0009] In one or more embodiments, the upper portion of the sidewall includes a sloped surface. In one or more embodiments, the sloped surface includes one or more finger grips. In one or more embodiments, the one or more finger grips are made of an elastomeric material.

[0010] In one or more embodiments, the cavity includes an inner surface having a cylindrical sidewall and a curved top wall. A set of external threads or tabs may be included on the outer surface of the sidewall of the housing, the external threads being sufficient to mate with a mating feature of the male luer connector. In one or more embodiments, the cavity may be configured to facilitate an interference fit between the cavity and the mating feature of the male luer connector. In one or more embodiments, the cavity may extend essentially from the inner surface of the top wall toward the open bottom of the housing. In one or more embodiments, the cavity may extend essentially parallel to the sidewall of the housing.

[0011] In one or more embodiments, a ball may be disposed within the cavity. In one or more embodiments, the ball may be disposed within the cavity, and the ball may be configured to provide a seal with the inner surface of the cavity in an initial state prior to connection of the luer connector to prevent the germicide or antimicrobial agent from escaping from the cavity. In one or more embodiments, the germicide or antimicrobial agent disinfects the outer and inner surfaces of the male luer connector when the male luer connector is inserted into the cavity and compresses the ball. In one or more embodiments, a removable seal may be attached to the open bottom of the housing, thereby forming a seal to maintain sterility and preserve the germicide or antimicrobial agent within the cavity prior to use of the cap.

[0012] In one or more embodiments, the sidewall of the housing comprises an upper portion and a lower portion. In one or more embodiments, the upper portion of the sidewall can be outwardly tapered and the lower portion of the sidewall can be cylindrical. In one or more embodiments, an exterior wall surface of the sidewall of the housing can include a plurality of gripping members.

[0013] In one or more embodiments, when the lure or lure tip of the male luer connector is received within the inner surface of the cavity, the hub is secured within the cavity of the cap by engaging at least a portion of the external threads with a mating feature on the hub of the male luer connector.

[0014] In one or more embodiments, the threads can include an inclined thread pattern.In one or more embodiments, the threads can include a helical thread pattern.

[0015] In one or more embodiments, the cap can include a removable peel seal covering the opening to the cavity to seal the ball and the disinfectant or antimicrobial agent in the cavity prior to use of the cap. In one or more embodiments, the ball can be constructed of rubber or plastic. In one or more embodiments, compression of the ball toward the top wall of the housing occurs upon connecting the disinfection cap to the male luer connector, whereby compression of the ball causes leakage of the disinfectant or antimicrobial agent in the cavity to disinfect the male luer connector.

[0016] In one or more embodiments, the disinfectant or antimicrobial agent may be selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In one or more specific embodiments, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0017] A second aspect of the disclosure relates to a cap including a housing. In one or more embodiments, the housing can include a sidewall including an outer surface having a semi-conical top portion having a flat top wall, a first portion having a tapered, cylindrical sidewall adjacent the semi-conical top portion, and a second portion having an essentially cylindrical sidewall adjacent the first portion. In one or more embodiments, the sidewall of the housing includes an upper portion and a lower portion. In one or more embodiments, the outer wall surface of the sidewall of the housing can include a plurality of gripping members. In one or more embodiments, the upper portion of the sidewall can be inwardly tapered and the lower portion of the sidewall can be cylindrical. In one or more embodiments, the upper portion of the sidewall of the housing can include a plurality of gripping members. In one or more embodiments, the plurality of gripping members is outwardly tapered. In one or more embodiments, the plurality of gripping members is teardrop shaped.

[0018] An open bottom is formed adjacent the second portion of the sidewall having an opening to a cavity in the housing for receiving the hub of a male luer connector.

[0019] One or more embodiments of the second aspect of the present disclosure include a ball, a disinfectant or antibacterial agent, and a removable seal. In one or more embodiments, the ball can be disposed within the cavity. In one or more embodiments, the ball is disposed within the cavity, and the ball is configured to provide a seal with an inner surface of the cavity in an initial state prior to connection of the male luer connector to prevent the disinfectant or antibacterial agent from leaking from the cavity.

[0020] In one or more embodiments, the cavity includes an inner surface having a first portion adjacent the open bottom having a straight cylindrical sidewall with a first diameter D1 smaller than the diameter of the ball, allowing the ball to rest on the first portion of the inner surface of the cavity. The inner surface of the cavity includes a second tapered portion disposed adjacent the first portion, the second tapered portion having a second diameter D2 increasing along the y-axis in a direction from the open bottom toward the top wall of the cavity. The inner surface of the cavity includes a third portion having a straight cylindrical sidewall with a plurality of ribs projecting toward a central axis of the cavity, the third portion of the inner surface of the cavity disposed adjacent the second portion. The third portion has a diameter D3 equal to or larger than the diameter of the ball, allowing the ball to undergo radial compression by the plurality of ribs disposed on the third portion of the inner surface of the cavity. The ball can be held in radial compression by the plurality of ribs to hold the ball within the cavity in the third portion. The interior surface of the cavity has a straight or curved top wall disposed distally from an open bottom.

[0021] In one or more embodiments, the cavity can be configured to facilitate an interference fit between the cavity and a mating feature of the male luer connector. In one or more embodiments, the cavity can extend essentially from an inner surface of the top wall of the cavity toward the open bottom of the housing. In one or more embodiments, the cavity can extend essentially parallel to the side wall of the housing.

[0022] In one or more embodiments of the second aspect of the present disclosure, the germicidal or antimicrobial agent sterilizes the outer and inner surfaces of the male luer connector when the male luer connector is inserted into the cavity and the ball is compressed.

[0023] In one or more embodiments, a removable seal can be attached to the open bottom of the housing, thereby forming a seal to preserve the disinfectant or antimicrobial agent within the cavity and maintain sterility prior to use of the cap.

[0024] The housing has an exterior surface with a set of external threads or tabs disposed thereon that are sufficient to mate with mating features of a male luer connector.

[0025] In one or more embodiments, when the hub of the male luer connector is received within the inner surface of the cavity, the hub is secured within the cavity of the cap by engaging at least a portion of the external threads with a mating feature on the hub of the male luer connector.

[0026] In one or more embodiments, the threads can include an inclined thread pattern. In one or more embodiments, the threads can include a helical thread pattern.

[0027] In one or more embodiments, the cap can include a removable peel seal covering the opening to the cavity, sealing the ball and disinfectant or antimicrobial agent in the cavity prior to use of the cap. In one or more embodiments, the ball can be composed of plastic, including but not limited to rubber, thermoplastic elastomers (TPE), thermoplastic polyolefins (TPO), and other elastomers or deformable materials. In one or more embodiments, upon connection to the male luer connector, compression of the ball occurs toward the top wall of the housing, thereby causing leakage of the disinfectant or antimicrobial agent in the cavity to disinfect the male luer connector.

[0028] In one or more embodiments, the disinfectant or antibacterial agent may be selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, t-butylhydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone-iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof. In one or more specific embodiments, the disinfectant or antibacterial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

[0029] A third aspect of the disclosure relates to a cap including a housing having a top wall, an essentially cylindrical sidewall forming a cavity, the cavity having an inner surface, and a ball disposed within a recessed portion of the cavity. The recessed portion is disposed adjacent to a second portion of the cavity. In one or more embodiments, the recessed portion and the ball form a liquid seal. In one or more embodiments, one or more channels are disposed on a surface of the second portion of the cavity. The second portion has a diameter D1, the diameter D1 being greater than a diameter of the ball. A germicide or antimicrobial agent is disposed within the second portion of the cavity. An open bottom is formed by the cylindrical sidewall with an opening into the cavity in the housing for receiving a hub of a male luer connector. The cavity has an inner surface having a first portion adjacent the open bottom with a tapered sidewall, the first portion having a second diameter D2 less than a diameter of the ball, the second diameter D2 increasing along a Y-axis in a direction from the open bottom toward the top wall of the cavity.

[0030] In one or more embodiments, external threads sufficient to mate with a mating feature of a male luer connector are disposed on an exterior surface of the cylindrical sidewall.

[0031] In one or more embodiments, the one or more channels are disposed on a surface of the second portion of the cavity.

[0032] A fourth aspect of the present disclosure relates to a cap including a housing having a top wall, an essentially cylindrical sidewall forming a cavity, the cavity having an inner surface, a ball, and an absorbent material disposed within the cavity.

[0033] A fifth aspect of the present disclosure relates to a method of disinfecting a medical connector, the method including connecting a cap of one or more embodiments to the medical connector, the connecting including engaging threads of the medical connector onto threads of an inner or outer surface of a second cavity of the cap upon insertion of the medical connector into the cap such that the medical connector comes into contact with the ball and a disinfectant or antimicrobial agent.

[0034] A sixth aspect of the present disclosure relates to an assembly comprising the cap of one or more embodiments connected to a medical connector, in one or more embodiments, the medical connector being selected from a male luer connector having a male fitting or other luer connector.

[0035] A seventh aspect of the present disclosure relates to packaging. In one or more embodiments, the caps of one or more embodiments disclosed herein can be packaged in a strip configuration.

[0036] 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 for use as an aid in determining the scope of the claimed subject matter.

[0037] 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 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 present disclosure as set forth hereinafter. [Brief description of the drawings]

[0038] [Figure 1] FIG. 1 is a perspective view of a cap according to a first exemplary embodiment of the present disclosure. [Diagram 2] FIG. 2 shows a cross-sectional view of a cap according to a first exemplary embodiment of the present disclosure. [Diagram 3] FIG. 3 illustrates a perspective view of a cap according to a second exemplary embodiment of the present disclosure. [Figure 4] FIG. 4 illustrates a cross-sectional view of a cap according to a second exemplary embodiment of the present disclosure. [Diagram 5] FIG. 5 illustrates a perspective view of a cap according to a third exemplary embodiment of the present disclosure. [Figure 6] FIG. 6 illustrates a cross-sectional view of a cap according to a third exemplary embodiment of the present disclosure. [Figure 7] FIG. 7 illustrates a cross-sectional perspective view of a cap according to a third exemplary embodiment of the present disclosure. [Figure 8] FIG. 8 shows a detailed cross-sectional perspective view of a cavity of a cap according to a third exemplary embodiment of the present disclosure. [Figure 9] FIG. 9 illustrates yet another detailed cross-sectional perspective view of a cavity of a cap according to a third exemplary embodiment of the present disclosure. [Figure 10A] FIG. 10A illustrates a perspective view of a connector according to a third exemplary embodiment of the present disclosure. [Figure 10B] FIG. 10B illustrates a detailed cross-sectional perspective view of a connector cap according to a third exemplary embodiment of the present disclosure. [Figure 11A]FIG. 11A shows a perspective view of a cap according to a third exemplary embodiment of the present disclosure. [Figure 11B] FIG. 11B illustrates a cross-sectional perspective view of a cap according to a third exemplary embodiment of the present disclosure. [Figure 12A] FIG. 12A shows a perspective view of a cap according to a fourth exemplary embodiment of the present disclosure. [Figure 12B] FIG. 12B illustrates a cross-sectional perspective view of a cap according to a fourth exemplary embodiment of the present disclosure. [Figure 13] FIG. 13 illustrates a detailed perspective view of the packaging of a connector cap according to an exemplary embodiment of the present disclosure. [Figure 14] FIG. 14 illustrates a cross-sectional view of a cap according to a fifth exemplary embodiment of the present disclosure. [Figure 15] FIG. 15 illustrates a perspective view of a cap according to a fifth exemplary embodiment of the present disclosure. [Figure 16] FIG. 16 illustrates a cross-sectional view of a cap according to a sixth exemplary embodiment of the present disclosure. [Figure 17] FIG. 17 illustrates a perspective view of a cap according to a sixth exemplary embodiment of the present disclosure. [Figure 18] FIG. 18 illustrates a perspective view of a cap according to a sixth exemplary embodiment of the present disclosure. [Figure 19] FIG. 19 illustrates a perspective view of a cap according to a seventh exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0039] Detailed Description An embodiment of the present disclosure relates to a disinfection cap for connecting to and disinfecting a medical connector, including a threaded connector. The connector may be a male or female luer connector. The present disclosure aims to provide a mechanism for providing effective disinfection around or around the connector or fitting while preventing ingress of disinfectant into the fluid pathway or lumen of the medical connector. It is contemplated that the disinfection cap disclosed herein may be utilized with male or female threaded connectors.

[0040] The following definitions are provided for terms used in this disclosure.

[0041] As used herein, the use of "a," "an," and "the" are inclusive of the singular and plural.

[0042] 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.

[0043] As used herein, the term "Luer connector" refers to a connecting collar that is a standard method of attaching syringes, catheters, hub needles, IV tubing, etc. to each other. Luer connectors consist of male-to-male mating tubes that are slightly tapered for better retention with even a simple pressure / torsion fit. Luer connectors can optionally include additional circumferential threads for added security. The Luer connector male end is typically associated with a flush syringe and can mate with a male end located on a vascular access device (VAD). The Luer connector has a distal end, a proximal end, an irregularly shaped outer wall, and a contoured central passage for fluid communication from the chamber of the syringe barrel to the hub of the VAD. The Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of the VAD and a proximal end channel that releasably attaches the Luer connector to the barrel of the syringe.

[0044] As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits tightly within a barrel or tube. The plunger rod can be pulled or pushed within the barrel, allowing the syringe to draw in or expel liquids or gases through an opening in the open end of the barrel.

[0045] As used herein, the term "medical device" refers to a general medical device having a threaded or interlocking connection, the connection having a corresponding interlocking element. By way of example and not limitation, a syringe may have a male threaded connection that releasably mates with a secondary medical device, such as a male luer connection of a catheter, IV line, etc. The threaded connection may include a lumen defining a fluid pathway surrounded by a protruding wall having threaded means for attachment to the secondary medical device.

[0046] As will be readily understood by one of ordinary skill in the relevant art, descriptive terminology such as "screw," "taper," "tab," "slope," "wall," "top," "side," "bottom," and the like are used throughout this specification for ease of understanding, but are not intended to limit any components that may be used in combination or separately to implement various aspects of the embodiments of the present disclosure.

[0047] 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 of the embodiments described herein can be made without departing from the scope and spirit of the present disclosure. Also, descriptions of well-known functions and structures are omitted for clarity and conciseness.

[0048] An embodiment of the cap of the present disclosure comprises a housing having a top wall defining a closed end, a sidewall having an inner surface defining a cavity, an open end formed by the cylindrical sidewall with an opening to the cavity in the housing for receiving a hub of a male luer connector, external threads on an outer surface of the cylindrical sidewall sufficient to mate with a mating feature of the male luer connector, a ball disposed within the cavity, and a disinfectant or antimicrobial agent, or fluid. The sidewall of the housing has a length L extending from the closed end to the open end. H The cavity sidewall has a length L that extends from a top wall of the cavity disposed at a closed end of the cavity to an open end defined by an open bottom that defines the length of the cavity. C In one or more embodiments, the exterior surface of the housing at the open end of the disinfection cap includes a peripheral shelf extending radially outward from the open end to define an end surface and an engagement surface for a peelable seal. The exterior surface of the lower portion of the housing has an exterior wall surface having one or more threads adapted to engage a male luer connector, or a threaded connection or a needleless medical connection or fitting. The cap may further include a peelable seal and / or a septum. The cap provides a mechanical barrier for the connector and contains an antimicrobial agent or fluid for disinfection. The cap of the present disclosure allows the practitioner to streamline the disinfection process.

[0049] In particular, when the cap is inserted or screwed onto the male connection of the medical device, the ball is forced further into the cavity, thereby discharging the antimicrobial agent or fluid past the ball and allowing disinfection of the male connection, while at the same time blocking the lumen of the male connection, thereby mitigating the antimicrobial agent or fluid from entering the fluid pathways or lumens of the device. The disinfectant is expelled and bathes around the male connector.

[0050] In an exemplary implementation of an embodiment of the present disclosure, the cap, connector cap or disinfection cap includes integrated threads or tabs and other features in any and all combinations that allow it to interface with a threaded fitting of a medical device. In a preferred embodiment, the cap interfaces with a male Luer fitting.

[0051] Exemplary configurations of couplers, fittings, ports and adapters may include commercially available luer locks, luer slip ports, locking ports, threaded connections, mating connections or other common medical device fittings commonly known in the art.

[0052] 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 as the present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0053] 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.

[0054] As shown in FIG. 1 and FIG. 2, a first aspect of the present disclosure relates to a disinfection cap 100 including a housing 110 having an upper portion 110A and a lower portion 110B. The upper portion 110A includes a top wall 112. As shown in FIG. 1, the upper portion 110A may include a finger rest 111 or tab to assist in holding and rotating the cap 100 to engage or disengage the cap 100 from a corresponding mating element on the outer surface of the male luer connector. The finger rest 111 provides a gripping surface for a user to grip the cap during use. The finger rest 111 may have any shape sufficient to provide a gripping surface for a user to grip the cap during use. In one or more embodiments, one or more surfaces of the finger rest 111 have a plurality of gripping members 113. In one or more embodiments, there are two finger rests 111 at opposite ends of the upper portion 110a of the housing for rotating the cap 100. As shown in FIG. 1, in one or more embodiments, the finger rest 111 includes a contoured surface including tapers and sloped surfaces. In one or more embodiments, the contoured surface may include one or more gripping members 113 on the surface of the finger rest 111 to improve gripping. The one or more gripping members 113 may have texture and may be made of an elastomeric material. In one or more embodiments, bumps may also be present on the finger rest to indicate where a user should grip the device to engage or disengage the cap from the male luer connector. In one or more embodiments, the finger rest 111 has a gently convex or concave surface. In one or more embodiments, the finger rest 111 has a surface texture to improve friction with the user's thumb.

[0055] In one or more embodiments, the lower portion 110B of the sidewall may be cylindrical. As shown in Figures 1 and 2, the upper portion 110A of the housing has an outwardly tapered sidewall, and the lower portion 110B of the housing includes an essentially cylindrical sidewall 132. In one or more embodiments, the cavity may be configured to facilitate an interference fit between the cavity and a mating feature of the male luer connector. In further embodiments, the cavity may be configured to facilitate a loose interference fit between the cavity and a mating feature of the male luer connector, and the cap 100 is secured by a set of external threads or tabs included on the outer surface of the housing. In one or more embodiments, the inner surface of the lower portion 110B of the housing defines a cavity 130 formed by the cylindrical sidewall 132 and having an open bottom 116 for receiving the hub of the male luer connector. In one embodiment, the cavity 130 is integrally formed with the housing 110. The cavity 130 includes an inner surface 131. In one or more embodiments, the cavity 130 includes an inner surface 131 having a cylindrical sidewall 131A and a curved top wall 131B. In one or more embodiments, the cavity 130 can extend essentially from the inner surface of the top wall toward the open bottom 116 of the housing 110. In one or more embodiments, the cavity 130 can extend essentially parallel to the sidewall 114 of the housing 110.

[0056] External threads or a set of tabs may be included on the exterior surface of the housing, the external threads being sufficient to mate with a mating feature on a male luer connector. In one or more embodiments, when a hub of the male luer connector is received within the interior surface of the cavity 130, the hub is secured within the cavity 130 of the cap 100 by mating at least a portion of the external threads 120 with a mating feature on the hub of the male luer connector. In one or more embodiments, the exterior surface of the housing 110 of the cap 100 of the present disclosure includes an external thread 120 having a size and pitch to engage with a threaded element or segment of a male connector, such as a male luer connector. In one or more embodiments, the threads 120 may include an inclined thread pattern. In one or more embodiments, the threads 120 may include a helical thread pattern. Such connectors are commonly and commonly used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, the cap 100 provides a protective cover for the male luer connector when engaged with the connector as threads from the male luer connector engage with threads 120 of the cap 100 to form a releasable connection. In one or more embodiments, as shown in FIG. 1, the threads 120 can be included on the exterior surface 31 of the sidewall 114 of the housing 110, the threads 120 being sufficient to engage with a mating feature or element of the male luer connector. According to yet another exemplary implementation of an embodiment of the present disclosure, the male threads disposed on the exterior surface of the sidewall of the housing have a size and thread pattern that engages with a standard ISO-2 type male fitting.

[0057] One or more aspects of the present disclosure include a ball 104, a disinfectant or antimicrobial agent 102, and a removable seal 122. In one or more embodiments, the ball 104 may be disposed within the cavity 130. In one or more embodiments, the ball 104 is configured to provide a seal with an inner surface 131 of the cavity 130 to prevent the disinfectant or antimicrobial agent 102 from leaking from the cavity 130 in an initial state prior to connection of the male luer connector. In a preferred embodiment, the ball 104 is compressible and may be a thermoplastic elastomer ("TPE"), a thermoplastic olefin ("TPO"), or an elastomeric or deformable material. In other embodiments, the ball 104 may be a rigid or hard plastic that deforms the housing 110. In further embodiments, the ball 110 may be glass, ceramic, metal, or a composite material.

[0058] In one or more embodiments, the germicidal or antimicrobial agent 102 sterilizes the outer surface or periphery of the male luer connector as it is inserted into the cavity 130, pushing the ball distally. In a preferred embodiment, the insertion compresses the ball 104. Upon further insertion into the cavity 100, the ball 104 forms an interference fit with the inner wall of the cavity 130 of the cap 100. In one or more embodiments, the ball 104 is soft and can form a slight clearance with the inner wall 131 of the cavity 130 when subjected to pressure.

[0059] When the cap 100 is inserted or screwed onto the threaded male connection, the ball 104 is forced further into the cavity 130, which allows the antimicrobial agent or fluid to be expelled past the ball and sanitize the male connection. The sanitizing agent is expelled and bathes around the male connector. The ball 104 simultaneously occludes the lumen of the male connection, thus mitigating the antimicrobial agent or fluid from entering the fluid pathway or lumen of the device. The seal formed between the ball 104 and the lumen of the male connection is aided by the deformation of the ball.

[0060] As shown in Figures 3 and 4, a second aspect of the disclosure relates to a cap 200 including a housing 210. In one or more embodiments, a sidewall 214 of the housing 210 includes an upper portion 210A and a lower portion 210B. As shown in Figures 3 and 4, in one or more embodiments, the upper portion 210A of the sidewall can be inwardly tapered and the lower portion 210B of the sidewall can be cylindrical. As shown in Figures 3 and 4, in one or more embodiments, the upper portion 210A of the housing 210 can include a semi-conical top portion having a flat top wall 212, a tapered cylindrical sidewall adjacent the semi-conical top portion, and a lower portion 210B having an essentially cylindrical sidewall. In one or more embodiments, the upper portion 210A of the housing sidewall can include a plurality of gripping members 213. In one or more embodiments, the plurality of gripping members 213 are outwardly tapered. In one or more embodiments, the plurality of gripping members 213 are teardrop shaped. The open bottom 216 at the proximal end of the housing has an opening to a cavity 330 in the housing 210 for receiving the hub of a male luer connector.

[0061] In one or more embodiments, the cavity 230 can be configured to facilitate an interference fit between the cavity 230 and a mating feature of the male luer connector. In one or more embodiments, the cavity 230 can extend essentially from an inner surface of the top wall of the cavity toward the open bottom of the housing. In one or more embodiments, the cavity can extend essentially parallel to the sidewall of the housing.

[0062] One or more embodiments of the second aspect of the disclosure include a ball 204, a disinfectant or antimicrobial agent 202, and a removable seal 222. In one or more embodiments, the ball 204 may be disposed within the cavity 230, where the ball 204 is configured to provide a seal with an inner surface 231 of the cavity 230 to prevent the disinfectant or antimicrobial agent 202 from leaking out of the cavity 230 in an initial state prior to connection of the male luer connector. When the cap 200 is inserted or screwed onto the threaded male connection, the ball 204 is forced further into the cavity 230, which allows the antimicrobial agent or fluid to be expelled past the ball and disinfect the male connection. The disinfectant is expelled and bathes around the male connector. The ball 204 simultaneously occludes the lumen of the male connection, thereby mitigating the antimicrobial agent or fluid from entering the fluid pathway or lumen of the device. The seal formed between the ball 204 and the lumen of the male connection is aided by deformation of the ball. Thus, the intended functions of cap 200 and ball 204 are to contain fluid to mitigate the ingress of disinfectants into the fluid pathways or lumens of the medical device, to apply or maintain pressure to seal the fluid pathway after installation, and to prevent fluid leakage when there is positive pressure in the line by skipping clamping the line.

[0063] In one or more embodiments, the cavity 230 includes an inner surface 230 having a first portion adjacent the open bottom 216 with straight cylindrical sidewalls having a first diameter D1 smaller than the diameter of the ball 204, allowing the ball 204 to rest on the first portion of the inner surface of the cavity. The inner surface of the cavity 231 includes a second tapered portion disposed adjacent the first portion, the second tapered portion having a second diameter D2 increasing along the y-axis in a direction from the open bottom 216 toward the top wall of the cavity. The inner surface of the cavity 231 includes a third portion having straight cylindrical sidewalls with a plurality of ribs 235 protruding toward a central axis of the cavity, the third portion of the inner surface of the cavity disposed adjacent the second portion. The third portion has a diameter D3 equal to or larger than the diameter of the ball 204, allowing the ball 204 to be under radial compression by the plurality of ribs 235 disposed on the third portion of the inner surface of the cavity. The ball 204 may be under radial compression by the plurality of ribs 235 to help retain the ball 204 in the cavity of the third portion. The inner surface of the cavity 231 has a straight or curved top wall disposed distally from the open bottom 216. In a preferred embodiment, the cavity 230 and the plurality of ribs 235 have a greater stiffness than the ball 204, such that as the ball 204 is pushed further into the cavity 230, the ball 204 compresses and deforms, allowing fluid to flow into the gaps created by the plurality of ribs 235. In a further embodiment, the cavity 230 and the plurality of ribs 235 may have a lesser stiffness than the ball 204, such that as the ball 204 is pushed further into the cavity 230, the cavity 230 and the plurality of ribs 235 may compress and allow fluid to flow into the gaps created by the plurality of ribs 235. The plurality of ribs 235 and the cavity 230 may have the same stiffness, but this is not required.

[0064] 3-4, the rim 224 of the open bottom 216 of the housing 210 may include a peripheral ledge extending radially outward from the open bottom annular sidewall that defines the end surface. The surface of the peripheral ledge also defines an engagement surface to which a peelable seal may be secured. In one or more embodiments, the cap may include a removable peel seal 222 covering the opening to the cavity 230 to seal the ball 204 and antiseptic or antimicrobial agent 202 within the cavity 230 prior to use of the cap 200.

[0065] 3 and 4, in one or more embodiments, a peelable seal 222 is disposed on the mating surface of the open bottom 216 of the housing 210 to form a seal to prevent the antiseptic or antimicrobial agent 202 from exiting the cavity 230, thereby maintaining sterility and retaining the antiseptic or antimicrobial agent within the cavity 230 prior to use of the cap. The peelable seal 222 minimizes the ingress of potential particulate hazards and also provides a substantially impermeable enclosure for the cap 200, provides a leak-proof and protective enclosure, protects the contents of the cavity 230, and / or maintains a sealed sterile environment. The peelable seal 222 provides a sufficient seal over a range of temperatures, pressures, and humidity levels.

[0066] As shown in Figures 1-6, the cavity (130, 230, 330) can include a closed distal end with a distal wall, an open proximal end, and a sidewall extending proximally from the distal wall towards the open proximal end.

[0067] A set of threads or tabs (120, 220, 320) are disposed on an exterior surface of the housing (110, 210, 310), and the set of threads or tabs (120, 220, 320) are sufficient to mate with mating features of a male luer connector.

[0068] In one or more embodiments, the cap (100, 200, 300) of the present disclosure has a set of threads or tabs (120, 220, 320) sized and pitched to engage a threaded segment of a corresponding male connector, such as a male luer connector. Such connectors are commonly and commonly used as catheters and other fluid-tight protective connectors in medical applications. In some embodiments, the cap (100, 200, 300) provides a protective cover for the male luer connector. In one or more embodiments, the threads can include an angled thread pattern. In one or more embodiments, the threads can include a helical thread pattern.

[0069] In one or more embodiments, when the hub of the male luer connector is received within the inner surface of the cavity, for example after the peel seal has been removed or pierced, the hub is secured within the cavity of the cap by engaging at least a portion of the threads or set of tabs (120, 220, 320) of the cap (100, 200, 300) with mating features on the hub of the male luer connector.

[0070] In one or more embodiments of the second aspect of the present disclosure, the ball 204 forms an interference fit with an inner wall of the cavity 230 of the cap 200. In one or more embodiments, the ball 204 may be under radial compression by a plurality of ribs 235 on the inner surface of the cavity 230 to retain the ball 204 within the cavity 230.

[0071] A third aspect of the disclosure relates to a sterile cap 300, as shown in Figures 5 and 6, a housing 310 includes a top wall 312, an essentially cylindrical side wall 314 forming a cavity 330, and an open bottom 316 formed by the cylindrical side wall 304 with an opening to the cavity 330 in the housing 310 for receiving the hub of a connector of a medical device. The connector of the medical device may be a threaded connection, a needle connection, or in a preferred embodiment, a male luer connector. In one or more embodiments, the cavity includes a closed distal end with a distal wall, an open proximal end, and a side wall extending proximally from the distal wall to the open proximal end. In one or more embodiments, a thread 320 is disposed on an exterior surface 318 of the housing 310, the thread 320 being sufficient to engage a mating feature of a male luer connector. In one or more embodiments, the threads may be formed as at least two tabs that may mate with twist-lock mating features of a connector of a medical device, hi further embodiments, the threads may be angled or helical in shape to correspond to the mating features of a connector of a medical device that is intended to be sterilized.

[0072] A peelable seal 322 (not shown) in the form of a film may be provided to seal the open bottom 316 prior to use of the sterile cap 300, and by way of example may comprise a peripheral shelf extending radially outwardly from the sidewall 314 at the open bottom 316 defining an end surface, by attachment of the open bottom 316 to a surface of the rim 324. The surface of the rim 324 also defines an engagement surface by which the sterile cap 300 may engage a mating surface of a male luer connector.

[0073] In one or more embodiments, the peelable seal 322 is disposed on the mating surface of the rim 324 to prevent the germicide or antimicrobial agent from exiting the cavity 330. The peelable seal 322 minimizes the ingress of potential particulate hazards and also provides a substantially impermeable enclosure for the cap 300, providing a leak-proof and protective enclosure to protect the contents contained within the cavity 330 and / or maintain a sealed sterile environment. The peelable seal 322 provides a sufficient seal over a range of temperatures, pressures, and humidity levels. In one or more embodiments, the peelable seal 322 comprises an aluminum or multi-layer polymer film peel back top. In further embodiments, the peelable seal 322 is heat sealed or induction sealed to the end face of the locking lid or the cap open end. In one or more embodiments, the peelable seal 322 comprises a moisture barrier. The sterile cap 300 may achieve sterilization when used with a common luer connector by incorporating a germicide or antimicrobial agent or fluid 302 into the cavity 330 of the housing 310.

[0074] In one or more embodiments, the cylindrical sidewall 314 defining the cavity may be tapered from the open bottom 316 to the top wall 312. In alternative embodiments, the cylindrical sidewall 314 may include multiple parallel portions, where the multiple parallel portions vary in diameter. In one or more embodiments, the cylindrical sidewall 314 may include multiple parallel portions and multiple tapered portions, where the multiple parallel portions and the multiple tapered portions vary in diameter.

[0075] As shown in FIG. 5, in one or more embodiments, the sidewall 314 of the housing 310 includes an upper portion 310a and a lower portion 310b. As shown in FIG. 5, in one or more embodiments, the upper portion 310A of the sidewall 310 may have a smaller diameter than the diameter of the lower portion 310B. As shown in FIG. 5, in one or more embodiments, the upper portion 310A of the housing 310 may include a tapered upper portion having a top wall 312. In one or more embodiments, the upper portion 310A of the housing sidewall may include a plurality of gripping members 313. In one or more embodiments, the plurality of gripping members 313 are outwardly tapered.

[0076] 7-9, the cylindrical sidewall 314 includes a first cylindrical portion 332, a recessed portion 336, and a second cylindrical portion 340. The proximal end of the first cylindrical portion 332 is positioned adjacent to the open bottom 316. The distal end of the first cylindrical portion is disposed adjacent to the proximal end of the recessed portion 336. The proximal end of the second cylindrical portion 340 is disposed adjacent to the distal end of the recessed portion 336. In some embodiments, chamfered or rounded transitions may be disposed at the transitions from the first cylindrical portion 332 to the recessed portion 336 and from the recessed portion 338 to the second cylindrical portion 340. As depicted in FIG. 9, the proximal chamfer 344 is disposed between the first cylindrical portion 332 and the recessed portion 336, and the distal chamfer 346 is disposed between the recessed portion 336 and the second cylindrical portion 340.

[0077] 6, ball 304 is received in recessed portion 336. Recessed portion 336 is defined by an arc 338 that extends from proximal chamfer 334 to distal chamfer 336. The arc diameter of arc 338 is less than or equal to the diameter of ball 304, such that arc 338 and ball 304 are in an interference fit that prevents any fluid or gas communication between first cylindrical portion 332 and second cylindrical portion 340.

[0078] First cylindrical portion 332 is defined by a tapered shape. A proximal diameter of first cylindrical portion 332 is greater than or equal to the diameter of ball 304. A distal diameter of first cylindrical portion 332 is approximately equal to the diameter of ball 304. Specifically, the distal diameter of first cylindrical portion 332 is configured to prevent ball 304 from inadvertently escaping recessed portion 336. The proximal diameter of first cylindrical portion 332 is often, but not necessarily, configured to create an interference fit with the stem of a luer or needleless connection.

[0079] Second cylindrical portion 340 is defined by a proximal section 348 and a distal section 350. Proximal section 348 has a diameter smaller than the diameter of ball 304. Proximal section 348 can limit distal movement of ball 304 through proximal section 348, with ball 304 and proximal section 348 having an interference fit. Distal section 350, having a diameter smaller than the diameter of ball 304, prevents ball 304 from moving further in the distal direction. Alternatively, distal section 350 can be tapered to prevent compressed ball 304 from moving further in the distal direction.

[0080] The proximal section 348 of the second cylindrical portion 340 may further include a plurality of apex channels 352 through which fluid can flow when the ball 304 is pressed within the proximal section 348. The plurality of channels extend radially into the housing 310. The plurality of apex channels 352 extend from the distal chamfer 346 to the distal section 350, and the proximal and distal ends of the plurality of apex channels 352 are tapered. The first cylindrical portion 332 may further include a plurality of bottom channels 352 through which fluid can flow when the ball 304 is pressed within the proximal section 348 of the second cylindrical portion 340. When the ball 304 is seated within the recessed portion 336, fluid or gas cannot flow from the plurality of apex channels 342 to the plurality of bottom channels 344 due to the interference fit of the ball 304 with the recessed portion 336. The multiple bottom channels 344 are intended to facilitate the penetration of a disinfectant or antimicrobial agent toward the mating surface of the male luer connector. By compressing the ball 304 toward the top wall 312 of the housing 310 upon connection to the male luer connector, the connector can be contacted with a disinfectant or antimicrobial agent to disinfect the male luer connector.

[0081] As shown in Figures 10A and 10B, an exemplary threaded male fitting 370 is depicted. The threaded male fitting 370 includes a lumen 372 disposed through a conical surface 374, a mating feature having at least one thread 376, and a mating surface 378 disposed at the bottom of the conical surface 374. Figures 11A and 11B show the ball 304 compressed within the cap 300 by engaging the threads 320 of the cap 300 onto the corresponding at least one thread 376 of the threaded male fitting 370. The surface of the rim 324 of the cap 300 abuts the mating surface 378 of the threaded male fitting 370. The ball 304 seals the lumen 372 and prevents the germicide from entering the flow path of the threaded male fitting 370.

[0082] In one or more embodiments of the exemplary cap 500, as shown in FIG. 14, the housing 510 comprises a top wall 512, an essentially cylindrical sidewall 514 forming a cavity 530, and an open bottom 516 formed by the cylindrical sidewall with an opening to the cavity 530 in the housing 510 for receiving the hub of a connector of a medical device. A threaded portion 520 is disposed on an outer surface 518 of the housing 510, the threaded portion 520 configured to mate with a mating feature of a male luer connector. In one or more embodiments, the threaded portion 520 may be formed as at least two tabs that may mate with a twist-lock mating feature of the connector of the medical device. In further embodiments, the threaded portion may be of a tapered or helical shape that corresponds to a mating feature of the connector of the medical device that is intended to be sterilized. The essentially cylindrical sidewall 514 further comprises a rim 524. The rim 524 projects proximally from the open bottom 516. The rim 524 is configured to prevent excess disinfectant from spilling around the perimeter of the luer connector when the cap 500 is fully inserted.

[0083] The cylindrical sidewall 514 includes a first cylindrical portion 532, a recessed portion 536, and a second cylindrical portion 540. A proximal end of the first cylindrical portion 532 is located adjacent the open bottom 516. A distal end of the first cylindrical portion is disposed adjacent the proximal end of the recessed portion 536. A proximal end of the second cylindrical portion 540 is disposed adjacent the distal end of the recessed portion 536. In some embodiments, chamfered or rounded transitions may be located at the transitions from the first cylindrical portion 532 to the recessed portion 536 and from the recessed portion 538 to the second cylindrical portion 540.

[0084] The proximal portion 548 of the second cylindrical portion 540 further includes a plurality of apex channels 552 through which fluid flows when a ball is pressed within the proximal portion 548, as described in embodiments of the present invention. The plurality of apex channels 552 extend radially into the housing 510. The plurality of apex channels 552 extend from the distal chamfer 546 to the distal section 550, with the proximal and distal ends of the plurality of apex channels 552 being tapered. In one or more embodiments, the plurality of apex channels 552 has a substantially rectangular cross-sectional shape.

[0085] In one or more embodiments, the first cylindrical portion 532 may further include a plurality of tabs 553 configured to have an interference fit with the hub of the male luer connector. The plurality of tabs 553 are sized to provide sufficient resistance with the hub of the male luer connector to prevent accidental or unintended removal of the cap 500 from the male luer connector. As shown in FIGS. 14-15 , in one or more embodiments, the plurality of tabs 553 have a trapezoidal cross-sectional shape, and a proximal end of the trapezoidal cross-sectional shape is substantially perpendicular to the cylindrical sidewall 514. In one or more embodiments, a distal end of the trapezoidal cross-sectional shape tapers distally from the proximal end of the trapezoidal cross-sectional shape. In one or more embodiments, where the sidewall has a loose fit with the hub of the male luer connector, the cap 500 is secured by an interference fit of the plurality of tabs 553.

[0086] As shown in FIG. 16, an exemplary threaded male fitting 570 is depicted. The threaded male fitting 570 includes a lumen 572 disposed through a distal tip 574 having a conical surface, a mating feature having at least one thread 576, and a mating surface 578 disposed at a proximal end of the distal tip 574. The ball 504 is compressed within the cap 500 by engaging the threads 520 of the cap 500 onto the corresponding at least one thread 576 of the threaded male fitting 570. In one or more embodiments, a surface of the rim 524 of the cap 500 may abut the mating surface 578 of the threaded male fitting 570, thereby preventing excess sterilant from escaping. As previously described in the embodiments of the present invention, the ball 504 seals the lumen 572 to prevent sterilant from entering the flow path of the threaded male fitting 570, and the sterilant is stored in a cavity 530 behind the ball 504. The disinfectant disinfects the conical surface of the hub 574 and the periphery of the threaded male fitting. A plurality of tapered tabs 553 form a drafted sidewall surface configured to have an interference fit with the hub of a male luer connector. In one or more embodiments, a plurality of tapered tabs 553 are disposed on the inner surface of the sidewall at the open end of the cap, forming a longitudinal draft configured to have an interference fit with the hub of a male luer connector.

[0087] As shown in FIG. 17, in one or more embodiments of the exemplary cap 600, the housing 610 is comprised of a top wall 612, an essentially cylindrical sidewall 614 forming a cavity 630, and an open bottom 616 formed by the cylindrical sidewall with an opening to the cavity 630 in the housing 610 for receiving the hub of a connector of a medical device. A threaded portion 620 is disposed on an outer surface 618 of the housing 610, the threaded portion 620 configured to mate with a mating feature of a male luer connector. In one or more embodiments, the threaded portion 620 may be formed as at least two tabs that may mate with a twist-lock mating feature of the connector of the medical device. In further embodiments, the threaded portion may be in a tapered or helical shape that corresponds to the mating feature of the connector of the medical device that is intended to be sterilized. The essentially cylindrical sidewall 614 further comprises a rim 624. The rim 624 projects proximally from the open bottom 616. The rim 624 is configured to prevent excess disinfectant from spilling around the perimeter of the luer connector when the cap 600 is fully inserted.

[0088] The cylindrical sidewall 614 includes a first cylindrical portion 632, a recessed portion 636, and a second cylindrical portion 640. A proximal end of the first cylindrical portion 632 is located adjacent the open bottom 616. A distal end of the first cylindrical portion is disposed adjacent the proximal end of the recessed portion 636. A proximal end of the second cylindrical portion 640 is disposed adjacent the distal end of the recessed portion 636. In some embodiments, chamfered or rounded transitions may be located at the transitions from the first cylindrical portion 632 to the recessed portion 636 and from the recessed portion 638 to the second cylindrical portion 640.

[0089] The proximal section 648 of the second cylindrical portion 640 further includes a plurality of apex channels 652 through which fluid flows when a ball is pressed into the proximal section 648, as described in embodiments of the present invention. The plurality of apex channels 652 extend radially within the housing 610. The plurality of apex channels 652 extend from the distal chamfer 646 to the distal section 650, with the proximal and distal ends of the plurality of apex channels 652 being tapered. In one or more embodiments, the plurality of apex channels 652 has a substantially rectangular cross-sectional shape.

[0090] In one or more embodiments, the first cylindrical portion 632 may further include a plurality of bottom channels 652 through which fluid can flow when the ball is pressed into the proximal section 648 of the second cylindrical portion 640. When the ball is seated within the recessed portion 636, fluid or gas cannot flow from the plurality of top channels 642 to the plurality of bottom channels 644 due to the interference fit of the ball with the recessed portion 636. The plurality of bottom channels 644 are intended to facilitate permeation of a disinfectant or antimicrobial agent toward the mating surface of the male luer connector. Compressing the ball toward the top wall 612 of the housing 610 upon connection to the male luer connector allows the connector to contact a disinfectant or antimicrobial agent to disinfect the male luer connector. In one or more embodiments, the top channel 642 and the bottom channel 644 have the same cross-sectional shape and width.

[0091] As shown in FIG. 18, an exemplary threaded male fitting 670 is depicted. The threaded male fitting 670 includes a hub 674 having a conical surface, a mating feature having at least one thread 676, and a lumen 672 disposed through a mating surface 678 disposed at a proximal end of the hub 674. The ball 604 is compressed within the cap 600 by engaging the threads 620 of the cap 600 onto the corresponding at least one thread 676 of the threaded male fitting 670. In one or more embodiments, a surface of the rim 624 of the cap 600 may abut the mating surface 678 of the threaded male fitting 670, thereby preventing excess sterilant from escaping. As previously described in the embodiments of the present invention, the ball 604 seals the lumen 672 to prevent sterilant from entering the flow path of the threaded male fitting 670, and the sterilant is stored in a cavity 630 behind the ball 604. The disinfectant disinfects the conical surface of the hub 674 and the periphery of the threaded male fitting. The inner surface of the open bottom 616 includes a drafted sidewall surface configured to have an interference fit with the hub of the male luer connector. In one or more embodiments, the drafted sidewall surface tapers radially outward toward the central axis of the cavity to form a longitudinal draft configured to have an interference fit with the hub of the male luer connector.

[0092] In one or more embodiments, an open bottom 716 formed by a cylindrical sidewall with an opening to a cavity in the housing for receiving the hub of a connector of a medical device has a taper 717 that tapers outwardly from the cylindrical sidewall toward the opening to the cavity. In one or more embodiments, the taper 717 is located 0.2 mm to 1 mm from the open bottom.

[0093] In one or more embodiments, recessed portion 738 disposed adjacent proximal cylindrical portion 732 is defined by an arc 738. Arc 738 has an arc angle R between 3 and 5 degrees, with a center C of the arc angle located 3.5 to 4.5 mm from the opening into the cavity. The arc has a proximal start location 387a and a distal end location. At proximal start location 378a, the diameter D of the cavity is between 4.5 and 5 mm.

[0094] 1-16, in one or more embodiments, the outer surface of the sidewall (114, 214, 314, 514, 614) comprises a plurality of gripping members (113, 213, 313). In one or more embodiments, the plurality of gripping members (113, 213, 313) are in the form of elongated ribs. A fourth aspect of the disclosure, as shown in FIGS. 12A and 12B, relates to a sterile cap 400, in which a housing 410 comprises a top wall 412, an essentially cylindrical sidewall 414 forming a cavity 430, and an open bottom 416 formed by the cylindrical sidewall 404 having an opening to the cavity 430 in the housing 410 for receiving a hub of a connector of a medical device. The connector of the medical device may be a threaded connection, a needleless connection, or in a preferred embodiment, a male luer connector. In one or more embodiments, the cavity includes a closed distal end with a distal wall, an open proximal end, and a sidewall extending proximally from the distal wall toward the open proximal end. In one or more embodiments, threads 420 are disposed on an exterior surface 418 of the housing 410, the threads 420 being sufficient to mate with a mating feature of a male luer connector. In one or more embodiments, the threads may be formed as at least two tabs that may mate with a twist-lock mating feature of a connector of a medical device. In further embodiments, the threads may be a beveled or helical shape that corresponds to a mating feature of a connector of a medical device that is intended to be sterilized. Referring to FIGS. 12A-12B, in one or more embodiments, the cap 400 includes an absorbent material 408 disposed within the cavity behind the ball 404. In one or more embodiments, the disinfectant or antimicrobial agent in the cavity 430 of the cap 400 is stored by the absorbent material 408 with the ball 404 on top of the absorbent material 408 for sealing. In one or more embodiments, the disinfectant or antimicrobial agent disinfects the exterior and interior surfaces of the male luer connector and causes the ball and the absorbent material 408 disposed behind the ball 404 to compress when the male luer connector is inserted into the cavity. In one or more embodiments, the absorbent material 408 is a nonwoven material, a foam, or a sponge. In one or more embodiments, the absorbent material is an open cell sponge.In a specific embodiment, the foam is polyurethane foam. In one or more embodiments, the absorbent material is held within the chamber by an interference fit with the interior sidewalls of the chamber. When the cap 400 is attached to the luer device, the male luer pushes on the ball 404, displacing the ball 404 toward the closed end of the cap housing, which compresses the absorbent material 408 and releases the germicide onto the luer surface.

[0095] In one or more embodiments, upon connection of the disinfection cap to the luer connector, compression of the absorbent material occurs toward the top wall of the housing, whereby the compression of the absorbent material causes the disinfectant or antibacterial agent in the cavity to leak out and disinfect the luer connector. The cap (100, 200, 300, 400, 500, 600), when used with the luer connector, can achieve disinfection by incorporating a disinfectant or antibacterial agent in the cavity (130, 230, 330, 530, 630) of the cap (100, 200, 300, 500, 600). The disinfectant or antibacterial agent (102, 202, 302) can be directly contained in the cavity (130, 230, 330, 530, 630). The caps (100, 200, 300, 500, 600) are designed to be compatible when interacting with various disinfectants or antimicrobial agents (102, 202, 302). In one or more embodiments, the disinfectants or antimicrobial agents (102, 202, 302) may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectants or antimicrobial agents (102, 202, 302) may include variations of alcohol or chlorhexidine. In one or more embodiments, the germicide or antimicrobial agent (102, 202, 302) is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butyl hydroxyanisole (BHA), butyl hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antimicrobial agents, and mixtures thereof. In a specific embodiment, the germicide or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the germicide or antimicrobial agent (102, 202, 302) is a fluid or gel.

[0096] In one or more embodiments, the cap (100, 200, 300, 500, 600) can include a removable peel seal (122, 222, 322) that covers the opening to the cavity to seal the ball (104, 204, 304, 504, 604) and the disinfectant or antimicrobial agent (102, 202, 302) within the cavity (130, 230, 330, 530, 630) prior to use of the cap (100, 200, 300, 500, 600). In one or more embodiments, the peelable seal (122, 222, 322) comprises an aluminum or multilayer polymer film peel back top. In a specific embodiment, the peelable seal (122, 222, 322) is heat or induction sealed to the open end of the cap (100, 200, 300). In one or more embodiments, the peelable seal (122, 222, 322) comprises a moisture barrier.

[0097] In preferred embodiments, the ball (104, 204, 304, 504, 604) is compressible and may be a thermoplastic elastomer ("TPE"), a thermoplastic olefin ("TPO"), or an elastomeric or deformable material. In other embodiments, the ball (104, 204, 304, 504, 604) may be a rigid or hard plastic that deforms the housing (110, 210, 310). In further embodiments, the ball (104, 204, 304, 504, 604) may be glass, ceramic, metal, or a composite material.

[0098] In one or more embodiments, the disinfectant or antimicrobial agent (102, 202, 302) disinfects the outer surface or periphery of the male luer connector when the male luer connector is inserted into the cavity (130, 230, 330, 530, 630) and pushes the ball distally. In a preferred embodiment, the insertion compresses the ball (104, 204, 304, 504, 604). The ball (104, 204, 304, 504, 604) forms an interference fit with the inner wall of the cavity (130, 230, 330, 530, 630) of the cap (100, 200, 300, 500, 600). In one or more embodiments, the ball (104, 204, 304, 504, 604) is soft and can form a small clearance with the interior sidewall of the cavity (130, 230, 330, 530, 630) when subjected to pressure.

[0099] The caps (100, 200, 300, 500, 600) are made from any of a number of types of plastic materials, such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene, or any other moldable plastic material used in medical devices. In one or more embodiments, the caps (100, 200, 300, 500, 600) comprise a polypropylene or polyethylene material.

[0100] In one or more embodiments, the connector of the medical device may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector of a primary IV gravity set, a secondary IV gravity set, an extension set, and an infusion or syringe pump set. In some embodiments, the cap can be connected to any of a variety of different needleless injection sites. In one or more embodiments, after the cap is mated with a connector, it is not necessary to disinfect the connector (e.g., treat with an alcohol swab) before reconnecting the connector with another connector, since the connector remains uncontaminated while mated with the cap. The use of the cap (100, 200, 300, 500, 600) replaces the standard wiping protocol for cleaning the connector.

[0101] A fifth aspect of the present disclosure relates to a method of disinfecting a medical connector, the method including connecting a cap (100, 200, 300, 500, 600) of one or more embodiments to the medical connector, the connecting including engaging threads of the medical connector with threads (120, 220, 320, 520, 620) of an outer surface of a sidewall (114, 214, 314, 514, 614) of a housing (110, 210, 310, 510, 614) of the cap upon insertion of the medical connector into the cap (100, 200, 300, 500, 600), such that the medical connector contacts the ball (104, 204, 304, 504, 604) and the disinfectant or antimicrobial agent (102, 202, 302).

[0102] A sixth aspect of the present disclosure relates to an assembly. The assembly comprises one or more embodiments of a cap (100, 200, 300, 500, 600) connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector or other needleless connector having a male fitting. In one or more embodiments, the male connector may be selected from the group consisting essentially of a needleless connector, a catheter luer connector, a stopcock, and a hemodialysis connector.

[0103] A seventh aspect of the present disclosure relates to packaging. With reference to FIG. 13, in one or more embodiments, the caps (100, 200, 300, 400, 500, 600) can be packaged in a strip configuration. As shown in FIG. 13, the strip configuration can include a single piece top web 409 to which multiple caps (100, 200, 300, 400, 500, 600) are attached via a sealing layer. The strip configuration can also include caps individually sealed with individual top web foils, and then a series of individually sealed caps are attached in an array manner to a portion of a strip made of a material such as plastic. The individual top web foils can have tabs attached to the strip material via an adhesive or via a sealant.

[0104] It is contemplated that the disinfection caps (100, 200, 300, 400, 500, 600) disclosed and shown in the figures may be utilized with female connectors, including female luer connectors, and that the balls (104, 204, 304, 404, 504, 604) may be used to occlude the open female luer lumen to facilitate mitigating the ingress of such disinfectants into the connector, thereby reducing the risk of the disinfectant entering the bloodstream. Thus, it is contemplated that the disinfection caps (100, 200, 300, 500, 600) disclosed and shown in the figures may be utilized with both male and female connectors.

[0105] Although 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. Also, the inner and / or outer housing of the cap may be single shot molded or manufactured by other suitable processes. Moreover, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and shown in the drawing figures may be implemented individually or in any combination(s) that would be readily understood by a person skilled in the art without departing from the spirit and scope of the embodiments of the present disclosure.

[0106] Additionally, the included drawing figures further illustrate non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of the associated technology. Any specific or relative dimensions or measurements provided in the figures, other than as described above, are illustrative and are not intended to limit the scope or content of the inventive designs or methodologies as would be understood by one of ordinary skill in the art of the associated invention.

[0107] Other objects, advantages, and salient features of the present disclosure will become apparent to those skilled in the art from the provided detailed description taken in conjunction with the accompanying drawings, in which exemplary embodiments of the present disclosure are disclosed.

[0108] 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 present disclosure. Thus, the appearances of phrases such as "in one or more embodiments," "a particular embodiment," "in one embodiment," or "in an embodiment" in various places herein are not necessarily all referring to the same embodiment of the present disclosure. Furthermore, the particular features, structures, materials, or characteristics may be combined in any suitable manner in one or more embodiments.

[0109] Although the disclosure herein has been described with reference to specific embodiments, it should 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 present disclosure. Therefore, the present disclosure is intended to cover modifications and variations that come within the scope of the appended claims and their equivalents.

Claims

1. The housing is top wall, an essentially cylindrical side wall forming a cavity; one or more ribs disposed on an interior surface of the cavity; a ball disposed within the cavity, the ball configured to provide a seal with the inner surface of the cavity in an initial state prior to connection of the male luer connector to prevent a germicidal or antimicrobial agent from escaping from the cavity; The bactericide or antibacterial agent, an open bottom defined by the cylindrical sidewall and having an opening for the cavity within the housing to receive a hub of the male luer connector; external threads on an exterior surface of said cylindrical sidewall, said external threads sufficient to mate with a mating feature of said male luer connector; A cap comprising a housing comprising: the cavity having a first portion adjacent the open bottom having a straight cylindrical sidewall with a first diameter D1 smaller than a diameter of the ball, a second tapered portion disposed adjacent the first portion, the second tapered portion having a second diameter D2 increasing in a direction from the open bottom toward the top wall of the cavity, and a third portion having a straight cylindrical sidewall with a plurality of ribs projecting toward a central axis of the cavity, the third portion of the inner surface of the cavity being disposed adjacent the second tapered portion and having a diameter D3 equal to or greater than the diameter of the ball.

2. 2. The cap of claim 1, wherein when a hub of the male luer connector is received within the inner surface of the cavity, the hub is secured within the inner surface of the cavity by engaging at least a portion of the external threads with a mating feature on the hub of the male luer connector.

3. 10. The cap of claim 1, further comprising a removable seal or septum attached to the open bottom of the cavity to form a seal to maintain the germicidal or antimicrobial agent within the cavity prior to use of the cap.

4. The cap of claim 1 , wherein an exterior wall surface of the side wall includes a plurality of gripping members.

5. The cap of claim 1 , wherein compression of the ball toward the top wall of the housing occurs upon connection with the male luer connector.

6. 6. The cap of claim 5, wherein compression of the ball disinfects the male luer connector.

7. 2. The cap of claim 1, wherein the ball is under radial compression by a ring-shaped depression on the inner surface of the cavity, retaining the ball within the cavity.

8. 2. The cap of claim 1, wherein the germicide or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylhydroxyanisole (BHA), butylhydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorhexidine, chlorhexidine diacetate, chlorhexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotics, and mixtures thereof.

9. 9. The cap of claim 8, wherein the germicidal or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

10. The cap of claim 1 , wherein the cavity extends essentially from an inner surface of the top wall toward the open bottom of the housing.

11. The cap of claim 1 , wherein the external threads include an inclined thread pattern.

12. The cap of claim 1 , wherein the external threads include a helical thread pattern.

13. The cap of claim 1 , wherein an upper portion of the side wall tapers outwardly toward the top wall and a lower portion of the side wall is cylindrical.

14. The cap of claim 13 , wherein an upper portion of the side wall includes a sloped surface.

15. The cap of claim 14 , wherein the sloping ramp includes one or more finger grips.

16. The cap of claim 15 , wherein the one or more finger grips are made from an elastomeric material.

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