Patent Description:
Vascular access devices (VAD's) are commonly used therapeutic devices and include intravenous (IV) catheters. There are two general classifications of VAD's: peripheral catheters and central venous catheters. Bacteria and other microorganisms may gain entry into a patient's vascular system from access hub, port, or valve upon connection to the VAD to deliver the fluid or pharmaceutical. Each access hub, port, valve or connection is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially lethal. In order to decrease CRBSI cases and to ensure VAD's are used and maintained correctly, standards of practice have been developed, which include disinfecting and cleaning procedures. Disinfection caps have been added to the Society for Healthcare Epidemiology of America (SHEA) guidelines and the Infusion Nurses Standards (INS) guidelines.

In developed markets, when utilizing an IV catheter, a needleless connector will typically be used to close off the system and then subsequently accessed to administer medication or other necessary fluids via the catheter to the patient. INS Standards of Practice recommend the use of a needleless connector and state that it should be "consistently and thoroughly disinfected using alcohol, tincture of iodine or chlorhexidine gluconate/alcohol combination prior to each access. " The disinfection of the needleless connector is ultimately intended to aid in the reduction of bacteria that could be living on the surface and possibly lead to a variety of catheter related complications including CRBSI. Nurses will typically utilize a <NUM>% isopropyl alcohol (IPA) pad to complete this disinfection task by doing what is known as "scrubbing the hub. " However, compliance to this practice is typically very low. In addition to a lack of compliance to "scrubbing the hub", it has also been noted through clinician interviews that there is often a variation in scrub time, dry time and the number of times the needleless connector is scrubbed.

The need to protect male connectors to reduce CLABSI and PLABSI has been rising. IV gravity sets and threaded male luer connections on syringes are subject to contamination when not protected properly. Currently when IV connectors are disconnected from central lines or peripheral lines to temporarily discontinue infusion, nurses often loop the male connector to a Y-site needle-free connector or wrap the male connector in a piece of Isopropyl Alcohol ("IPA")/alcohol impregnated wipe or cloth. However such protection is very weak and does not protect the luer from touch contamination properly. Male disinfection caps have become the state of art disinfection and protection device to disinfect and create a physical barrier on male connector to prevent microbial growth.

Throughout the sequence of procedures associated with the transmission of a microorganism that can cause a CRBSI, there are many risks of contact or contamination. By way of example, contamination can occur during drug mixing, attachment of a cannula, and insertion into the access hub. Furthermore, threaded male connectors have an open luer with an exposed lumen. Because the procedure to connect to a VAD is so common and simple, the risk associated with entry into a patient's vascular system has often been overlooked. Presently, the risk to hospitals and patients is a substantial function of the diligence of the clinician performing the connection, and this diligence is largely uncontrollable.

Disinfectants typically have a threshold limit for systemic exposure for infusion into blood stream due to biotoxicity of the disinfectants at high dosage. Thus, there is a need for a disinfection device capable of blocking the lumen of open luers to facilitate the mitigation of such disinfectant ingress into connectors, thereby reducing risk of the disinfectant entering the blood stream. There is a need for a mechanism to prevent disinfectant from entering the lumen and fluid path while providing effective disinfection of the surrounding connector or fitting. <CIT> discloses a cleaning cap for a medical implement having a male protrusion. Another cleaning cap for disinfecting male luers is disclosed in <CIT>.

A first aspect of the present disclosure relates to a cap including a housing, a ball, a disinfectant or an antimicrobial agent and a removable seal. The housing includes a top wall, an essentially cylindrical sidewall having an exterior surface and an interior surface forming a cavity, and an open bottom formed by the cylindrical sidewall with an opening to the cavity within the housing for receiving a hub of a male luer connector.

In one or more embodiments, the upper portion of the sidewall of the housing is tapered outward toward the top wall and the lower portion of the sidewall is cylindrical.

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

In one or more embodiments, the cavity includes an inner surface having a cylindrical sidewall and a curved top wall. An outer thread or set of tabs can be included on the exterior surface of the sidewall of the housing, the outer thread being sufficient to interlock with a mating feature of the male luer connector. In one or more embodiments, the cavity can be configured to facilitate interference fit between the cavity and the mating feature of the male luer connector. In one or more embodiments, the cavity can extend essentially from an inside surface of the top wall toward the open bottom of the housing. In one or more embodiments, the cavity can extend essentially parallel to the sidewall of the housing.

In one or more embodiments, the ball can be disposed within the cavity. In one or more embodiments, the ball disposed within the cavity and the ball is configured to provide a tight seal with the inside surface of the cavity to prevent the disinfectant or the antimicrobial agent from leaking out of the cavity in an initial state, prior to the connection of a male luer connector. In one or more embodiments, the disinfectant or antimicrobial agent disinfects an outer surface and an inner surface of the male luer connector when the male luer connector is inserted into the cavity and compresses the ball. In one or more embodiments, the removable seal can be attached to the open bottom of the housing thereby forming a seal for maintaining sterility and preserving the disinfectant or an antimicrobial agent within the cavity prior to use of the cap.

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 tapered outward 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 grip members.

In one or more embodiments, when a luer or luer 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 interlocking at least a portion of the outer thread with a mating feature on the hub of the male luer connector.

In one or more embodiments, the thread can include an inclined thread pattern. In one or more embodiments, the thread can include a helical-shaped thread pattern.

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

In one or more embodiments, the disinfectant or the antimicrobial agent can be selected from the group consisting essentially of isopropyl alcohol, ethanol, <NUM>-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In one or more specific embodiments, the disinfectant or antimicrobial agent includes at least one of chlorhexidine gluconate and chlorhexidine diacetate.

A second aspect of the present disclosure relates to a cap including a housing. In one or more embodiments, the housing can include a semi-conical top portion having a flat top wall, a sidewall including an exterior surface having a first portion having a tapered cylindrical sidewall adjacent to the semi-conical top portion and a second portion having an essentially cylindrical sidewall adjacent to the first portion. In one or more embodiments, the sidewall of the housing comprises an upper portion and a lower portion. In one or more embodiments, an exterior wall surface of the sidewall of the housing can include a plurality of grip members. In one or more embodiments, the upper portion of the sidewall can be tapered inward 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 grip members. In one or more embodiments, the plurality of grip members taper outward. In one or more embodiments, the plurality of grip members are tear-shaped.

An open bottom formed adjacent to the second portion of the sidewall with an opening to the cavity within the housing for receiving a hub of a male luer connector.

One or more embodiments of the second aspect of the present disclosure include a ball, a disinfectant or an antimicrobial 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 tight seal with the inner surface of the cavity to prevent the disinfectant or the antimicrobial agent from leaking out of the cavity in an initial state prior to the connection of a male luer connector.

According to the invention, the cavity includes an inner surface having a first portion adjacent to the open bottom having a straight cylindrical sidewall having a first diameter D1 which is smaller than the diameter of the ball to allow the ball to rest on the first portion of the inner surface of the cavity. The inner surface of cavity includes a second tapered portion disposed adjacent to the first portion, the second tapered portion having second diameter D2 that increases along the y-axis in a direction from the open bottom toward a top wall of the cavity. The inner surface of cavity includes a third portion having a straight cylindrical sidewall having a plurality of ribs protruding toward the central axis of the cavity, the third portion of the inner surface of the cavity disposed adjacent to the second portion. The third portion having Diameter D3 that is equal to or greater than the diameter of the ball such that the ball can be under radial compression by the plurality of ribs disposed on the third portion of the inner surface of the cavity. The ball is held under radial compression by the plurality of ribs to retain the ball in the third portion cavity. The inner surface of the cavity having a straight or curved top wall disposed distally from the open bottom.

In one or more embodiments, the cavity can be configured to facilitate interference fit between the cavity and the mating feature of the male luer connector. In one or more embodiments, the cavity can extend essentially from an inner surface of a 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.

In one or more embodiments of the second aspect of the present disclosure, the disinfectant or antimicrobial agent disinfects an outer surface and an inner surface of the male luer connector when the male luer connector is inserted into the cavity and compresses the ball.

In one or more embodiments, the removable seal can be attached to the open bottom of the housing thereby forming a seal for maintaining sterility and preserving the disinfectant or an antimicrobial agent within the cavity prior to use of the cap.

An outer thread or set of tabs is disposed on the exterior surface of the housing, the outer thread or set of tabs being sufficient to interlock with a mating feature of the male luer connector.

In one or more embodiments, when a 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 interlocking at least a portion of the outer thread with a mating feature on the hub of the male luer connector.

In one or more embodiments, the cap can include a removable peel seal covering the opening to the cavity to seal the ball and disinfectant or antimicrobial agent within the cavity prior to use of the cap. In one or more embodiments, the ball can be composed of rubber, plastic including but not limited to thermoplastic elastomer (TPE), thermoplastic polyolefin (TPO) and other elastomeric or deformable material. In one or more embodiments, a compression of the ball toward the top wall of the housing occurs upon connection to the male luer connector, whereby compression of the ball leads to the leakage of the disinfectant or antimicrobial agent within the cavity to disinfect the male luer connector.

A third 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 disposed within an indented portion of the cavity. The indented portion is positioned adjacent to a second portion of the cavity. In one or more embodiments, the indented 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 larger than a diameter of the ball. A disinfectant or antimicrobial agent is disposed within the second portion of the cavity. An open bottom is formed by the cylindrical sidewall with an opening to the cavity within said housing for receiving a hub of a male luer connector. The cavity has an inner surface with a first portion adjacent to the open bottom having a tapered sidewall, the first portion having a second diameter D2 which is smaller than the diameter of the ball, and the second diameter D2 increasing along the y-axis in a direction from the open bottom toward a top wall of the cavity.

In one or more embodiments, an outer thread being sufficient to interlock with a mating feature of said male luer connector is disposed on the outer surface of the cylindrical sidewall.

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

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 absorbent material disposed within the cavity.

A fifth aspect of the present disclosure pertains to a method of disinfecting a medical connector. The method comprises connecting the cap of one or more embodiments to a medical connector, wherein connecting includes engaging the threads of the medical connector onto the threads on the inner or outer surface of the second cavity of the cap upon insertion of the medical connector into the cap such that the medical connector contacts the ball and the disinfectant or antimicrobial agent.

A sixth aspect of the present disclosure pertains to an assembly. The assembly comprises the cap of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector or other luer connector having a male fitting.

A seventh aspect of the present disclosure pertains to packaging. In one or more embodiments, the cap of one or more embodiments disclosed herein can be packaged into a strip configuration.

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

Embodiments of the disclosure pertain to a disinfection cap for connection to and disinfection of a medical connector, including threaded connectors. The connectors may be male luer connectors or a female luer connector. The disclosure aims to provide a mechanism to prevent disinfectant from entering the fluid path or a lumen of the medical connector while providing for effective disinfection for a periphery or the surrounding connector or fitting. It is contemplated that the disinfection cap disclosed herein may be utilized with male or female threaded connectors.

With respect to terms used in this disclosure, the following definitions are provided.

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

As used herein, the term "catheter related bloodstream infection" or "CRBSI" refers to any infection resulting from the presence of a catheter or IV line.

As used herein, the term "Luer connector" refers to a connection collar that is the standard way of attaching syringes, catheters, hubbed needles, IV tubes, etc. to each other. The Luer connector consists of male and male interlocking tubes, slightly tapered to hold together better with even just a simple pressure/twist fit. Luer connectors can optionally include an additional outer rim of threading, allowing them to be more secure. The Luer connector male end is generally associated with a flush syringe and can interlock and connect to the male end located on the vascular access device (VAD). A Luer connector comprises a distal end, a proximal end, an irregularly shaped outer wall, a profiled center passageway for fluid communication from the chamber of the barrel of a syringe to the hub of a VAD. A Luer connector also has a distal end channel that releasably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.

As used herein, the term "syringe" refers to a simple pump-like device consisting of a plunger rod that fits tightly in a barrel or tube. The plunger rod can be pulled or pushed along inside the barrel, allowing the syringe to take in and expel a liquid or gas through an opening at the open end of the barrel.

As used herein, the term "medical device" refers to common medical devices having threaded or interlocking connections, the connections having corresponding mating elements. By way of example but not limitation, a syringe may have a male threaded connection which releasably interlocks with a secondary medical device such as a male luer connection of a catheter, an IV line and the like. The threaded connection may include a lumen defining a fluid path surrounded by a protruding wall having the threaded means for attaching to the secondary medical device.

As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as "thread", "taper", "tab", "slant", "wall", "top", "side", "bottom" and others are used throughout this specification to facilitate understanding, it is not intended to limit any components that can be used in combinations or individually to implement various aspects of the embodiments of the present disclosure.

The matters exemplified in this description are provided to assist in a comprehensive understanding of exemplary embodiments of the disclosure. Accordingly, those of ordinary skill in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

Embodiments of the cap of the present disclosure comprise a housing having a top wall defining a closed end, a sidewall having an inner surface defining a cavity, an open end formed by said cylindrical sidewall with an opening to a cavity within said housing for receiving a hub of a male luer connector, an outer thread on an exterior surface of the cylindrical sidewall that is sufficient to interlock with a mating feature of said male luer connector, a ball disposed within the cavity, and a disinfectant or antimicrobial agent, or fluid. The sidewall of the housing having a length LH extending from the closed end to an open end and defining the length of the disinfection cap. The sidewall of the cavity having a length LC extending from the top wall of the cavity disposed at the closed end of the cavity to an open end defined by the open bottom defining the length of the cavity. In one or more embodiments, the exterior surface of the housing at the open end of the disinfection cap includes a peripheral ledge extending radially outward from the open end defining an end face and an engagement surface for a peelable seal. The outer surface of the lower portion of the housing having 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 comprise a peelable seal and/or septum. The cap provides a mechanical barrier for connectors and contains an antimicrobial agent or fluid for disinfection. The cap of the present disclosure allows the practitioner to streamline the disinfecting process.

In particular, inserting or threading the cap onto a male connection of a medical device pushes the ball further into the cavity, thereby releasing the antimicrobial agent or fluid past the ball allowing for disinfection of the male connection, while the ball simultaneously blocks a lumen of the male connection, thus mitigating antimicrobial agent or fluid from entering the device's fluid path or lumen. The disinfectant is dispensed, bathing the periphery of the male connector.

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

Exemplary configurations for couplers, fittings, ports and adapters may include commercially available luer locks, luer slip ports, locking ports, threaded connections, interlocking connection or generally other common medical device fitting known in the art.

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

Referring now to the drawings, wherein like reference numerals designate identical or corresponding parts throughout the several views, embodiments of the present disclosure are described as follows.

As shown in <FIG> and <FIG>, a first aspect of the present disclosure relates to a disinfection cap <NUM> including housing <NUM> having an upper portion 110A and a lower portion 110B. The upper portion 110A including a top wall <NUM>. As shown in <FIG>, upper portion 110A may include a finger rest <NUM> or tab to assist in holding and rotating the cap <NUM> to either engage or disengage the cap <NUM> from the corresponding mating element on the exterior surface of the male luer connector. The finger rest <NUM> provides a gripping surface for the user to grasp the cap during use. The finger rest <NUM> may have any shape sufficient to provide a gripping surface for the user to grasp the cap during use. In one or more embodiments, one or more surfaces of finger rest <NUM> having a plurality of grip members <NUM>. In one or more embodiments, there two finger rests <NUM> on opposing ends of the upper portion 110A of the housing for turning the cap <NUM>. In one or more embodiments, as shown in <FIG>, the finger rest <NUM> includes a contoured surface including tapers and slanting surfaces. In one or more embodiments, the contoured surface may include one or more grip members <NUM> on the surface of the finger rest <NUM> to improve grip. The one or more grip members <NUM> may be textured and may made of an elastomeric material. In one or more embodiments, bumps may also be present on the finger rest to indicate where to the user may grip the device to engage or disengage the cap from the male luer connector. In one or more embodiments, finger rest <NUM> has a gently convex or concave surface. In one or more embodiments, finger rest <NUM> has surface texture to improve friction with the thumb of a user.

In one or more embodiments, the lower portion 110B of the sidewall may be cylindrical. As shown in <FIG> and <FIG>, the upper portion 110A of the housing has an outwardly tapered sidewall and the lower portion 110B of the housing including an essentially cylindrical sidewall <NUM>. In one or more embodiments, the cavity can be configured to facilitate an interference fit between the cavity and the mating feature of the male luer connector. In further embodiments, the cavity can be configured to facilitate a loose fit between the cavity and the mating feature of the male luer connector, wherein the cap <NUM> is secured by an outer thread or set of 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 <NUM> having open bottom <NUM> formed by the cylindrical sidewall <NUM> for receiving a hub of a male luer connector. In one embodiment, cavity <NUM> is integrally formed with the housing <NUM>. Cavity <NUM> includes an inner surface <NUM>. In one or more embodiments, the cavity <NUM> includes an inner surface <NUM> having a cylindrical sidewall 131A and a curved top wall 131B. In one or more embodiments, the cavity <NUM> can extend essentially from an inner surface of the top wall toward the open bottom <NUM> of the housing <NUM>. In one or more embodiments, the cavity <NUM> can extend essentially parallel to the sidewall <NUM> of the housing <NUM>.

The outer thread or set of tabs can be included on the outer surface of the housing, the outer thread being sufficient to interlock with a mating feature of the male luer connector. In one or more embodiments, when a hub of the male luer connector is received within the inner surface of the cavity <NUM>, the hub is secured within the cavity <NUM> of the cap <NUM> by interlocking at least a portion of the outer thread <NUM> with a mating feature on the hub of the male luer connector. In one or more embodiments, the exterior surface of the housing <NUM> of the cap <NUM> of the present disclosure includes outer thread <NUM> that has a size and pitch to engage a threadable element or segment of a male connector, such as for example, a male luer connector. In one or more embodiments, the thread <NUM> can include an inclined thread pattern. In one or more embodiments, the thread <NUM> can include a helical-shaped thread pattern. Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, cap <NUM> provides a protective cover for a male luer connector when engaged with the connector when threads from the male luer connector engage and form a releasable connection with threads <NUM> of cap <NUM>. In one or more embodiments, as shown in <FIG>, thread <NUM> can be included on the exterior surface <NUM> of sidewall <NUM> of the housing <NUM>, the thread <NUM> being sufficient to interlock with a mating feature or element of the male luer connector. According to still further exemplary implementations of the embodiments of the present disclosure, male threads disposed on the exterior surface of the sidewall of the housing are sized and have a thread pattern that will engage with a standard ISO-<NUM> type of male fitting.

One or more aspects of the present disclosure include a ball <NUM>, a disinfectant or an antimicrobial agent <NUM> and a removable seal <NUM>. In one or more embodiments, the ball <NUM> can be disposed within the cavity <NUM>. In one or more embodiments, the ball <NUM> is configured to provide a tight seal with the inner surface <NUM> of the cavity <NUM> to prevent the disinfectant or the antimicrobial agent <NUM> from leaking out of the cavity <NUM> in an initial state prior to the connection of a male luer connector. In the preffered embodiment the ball <NUM> can be compressible and may be a thermoplastic elastomer ("TPE"), thermoplastic olefin ("TPO"), or an elastomer or deformable material. In other embodiments, the ball <NUM> may be of a rigid or hard plastic causing the housing <NUM> to deform. In further embodiments, the ball <NUM> may be glass, ceramic, metal or a composite material.

In one or more embodiments, the disinfectant or antimicrobial agent <NUM> disinfects an outer surface or periphery the male luer connector when the male luer connector is inserted into the cavity <NUM> and pushes the ball in a distal direction. In the preferred embodiment, the insertion compresses the ball <NUM>. When inserted further into the cavity <NUM>, the ball <NUM> forms an interference fit with an inner wall of the cavity <NUM> of the cap <NUM>. In one or more embodiments, the ball <NUM> is soft and can form a slight clearance with inner sidewall <NUM> of the cavity <NUM> when subject to pressure.

Inserting or threading the cap <NUM> onto the threaded male connection causes the ball <NUM> to be further pushed into the cavity <NUM>, thereby releasing the antimicrobial agent or fluid past the ball, allowing for disinfection of the male connection. The disinfectant is dispensed, bathing the periphery of the male connector. The ball <NUM> simultaneously blocks a lumen of the male connection, thus mitigating antimicrobial agent or fluid from entering the device's fluid path or lumen. The seal created between the ball <NUM> and the lumen of the male connection is aided by ball deformation.

As shown in <FIG> and <FIG>, a second aspect of the present disclosure relates to a cap <NUM> including a housing <NUM>. In one or more embodiments, the sidewall <NUM> of the housing <NUM> comprises an upper portion 210A and a lower portion 210B. As shown in <FIG> and <FIG>, in one or more embodiments, the upper portion 210A of the sidewall can be tapered inward and the lower portion 210B of the sidewall can be cylindrical. In one or more embodiments, as shown in <FIG> and <FIG>, the upper portion 210A of housing <NUM> can include a semi-conical top portion having a flat top wall <NUM>, a tapered cylindrical sidewall adjacent to 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 sidewall of the housing can include a plurality of grip members <NUM>. In one or more embodiments, the plurality of grip members <NUM> taper outward. In one or more embodiments, the plurality of grip members <NUM> are tear-shaped. An open bottom <NUM> at the proximal end of the housing having an opening to the cavity <NUM> within the housing <NUM> for receiving a hub of a male luer connector.

In one or more embodiments, the cavity <NUM> can be configured to facilitate interference fit between the cavity <NUM> and the mating feature of the male luer connector. In one or more embodiments, the cavity <NUM> can extend essentially from an inner surface of a 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.

One or more embodiments of the second aspect of the present disclosure includes a ball <NUM>, a disinfectant or an antimicrobial agent <NUM> and a removable seal <NUM>. In one or more embodiments, the ball <NUM> can be disposed within the cavity <NUM> and the ball <NUM> is configured to provide a tight seal with the inner surface <NUM> of the cavity <NUM> to prevent the disinfectant or the antimicrobial agent <NUM> from leaking out of the cavity <NUM> in an initial state prior to the connection of a male luer connector. Inserting or threading the cap <NUM> onto the threaded male connection causes the ball <NUM> to be further pushed into the cavity <NUM>, thereby releasing the antimicrobial agent or fluid past the ball, allowing for disinfection of the male connection. The disinfectant is dispensed, bathing the periphery of the male connector. The ball <NUM> simultaneously blocks a lumen of the male connection, thus mitigating antimicrobial agent or fluid from entering the device's fluid path or lumen. The seal created between the ball <NUM> and the lumen of the male connection is aided by ball deformation. Thus, the intended function of the cap <NUM> and ball <NUM> is to contain the fluid, mitigate disinfectant ingress into the fluid path or lumen of the medical device and pressure seal or hold pressure in the fluid path after attachment to prevent fluid leakage when there is positive pressure in the line caused by skipping clamping the line.

In one or more embodiments, the cavity <NUM> includes an inner surface <NUM> having a first portion adjacent to the open bottom <NUM> having a straight cylindrical sidewall having a first diameter D1which is smaller than the diameter of the ball <NUM> to allow the ball <NUM> to rest on the first portion of the inner surface of the cavity. The inner surface of cavity <NUM> includes a second tapered portion disposed adjacent to the first portion, the second tapered portion having second diameter D2 that increases along the y-axis in a direction from the open bottom <NUM> toward the top wall of the cavity. The inner surface of cavity <NUM> includes a third portion having a straight cylindrical sidewall having a plurality of ribs <NUM> protruding toward the central axis of the cavity, the third portion of the inner surface of the cavity disposed adjacent to the second portion. The third portion having diameter D3 that is equal to or greater than the diameter of the ball <NUM> such that the ball <NUM> can be under radial compression by the plurality of ribs <NUM> disposed on the third portion of the inner surface of the cavity. The ball <NUM> may be placed under radial compression by the plurality of ribs <NUM>, helping in retention of the ball <NUM> in the third portion cavity. The inner surface of the cavity <NUM> having a straight or curved top wall disposed distally from the open bottom <NUM>. In the preferred embodiment, the cavity <NUM> and plurality of ribs <NUM> have a greater rigidity than the ball <NUM>, thus when the ball <NUM> is pushed further into the cavity <NUM>, the ball <NUM> compressed and deforms, allowing for fluid to flow in between gaps created by the plurality of ribs <NUM>. In further embodiments, the cavity <NUM> and plurality of ribs <NUM> may have less rigidity than the ball <NUM>, compressing the cavity <NUM> and the plurality of ribs <NUM> as the ball <NUM> is pushed further into the cavity <NUM>, where fluid flows flow in between gaps created by the plurality of ribs <NUM>. The plurality of ribs <NUM> and the cavity <NUM> may, but not necessarily, have the same rigidity.

Referring to <FIG>, rim <NUM> of an open bottom <NUM> of housing <NUM> may include a peripheral ledge extending radially outward from the annular sidewall at the open bottom defining an end face. The surface of the peripheral edge also defines an engagement surface where a peelable seal may be secured. In one or more embodiments, the cap can include a removable peel seal <NUM> covering the opening to the cavity <NUM> to seal the ball <NUM> and disinfectant or antimicrobial agent <NUM> within the cavity <NUM> prior to use of the cap <NUM>.

Referring to <FIG> and <FIG>, in one or more embodiments, the peelable seal <NUM> is disposed on the engagement surface of open bottom <NUM> of housing <NUM> to prevent the disinfectant or the antimicrobial agent <NUM> from exiting the cavity <NUM> and thereby also forming a seal for maintaining sterility and preserving the disinfectant or an antimicrobial agent within the cavity <NUM> prior to use of the cap. The peelable seal <NUM> minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the cap <NUM>, provides a leak prevention and protection enclosure, protects the contents of the cavity <NUM>, and/or maintains a sealed, sterilized environment. The peelable seal <NUM> provides a sufficient seal at a range of temperatures, pressures, and humidity levels.

As shown in <FIG>, cavity (<NUM>, <NUM>, <NUM>) can include a closed distal end comprising a distal wall, an open proximal end, a sidewall extending proximally from the distal wall toward the open proximal end.

A thread or set of tabs (<NUM>, <NUM>, <NUM>) is disposed on the exterior surface of the housing (<NUM>, <NUM>, <NUM>), the thread or set of tabs (<NUM>, <NUM>, <NUM>) being sufficient to interlock with a mating feature of the male luer connector.

In one or more embodiments, the cap (<NUM>, <NUM>, <NUM>) of the present disclosure has thread or set of tabs (<NUM>, <NUM>, <NUM>) that have a size and pitch to engage a threadable segment of a corresponding male connector, such as for example, a male luer connector. Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, cap (<NUM>, <NUM>, <NUM>) provides a protective cover for a male luer connector. In one or more embodiments, the thread can include an inclined thread pattern. In one or more embodiments, the thread can include a helical-shaped thread pattern.

In one or more embodiments, when a hub of the male luer connector is received within the inner surface of the cavity, for example after a peel seal is removed or when the peal seal is pierced, the hub is secured within the cavity of the cap by interlocking at least a portion of the threads or set of tabs (<NUM>, <NUM>, <NUM>) of cap (<NUM>, <NUM>, <NUM>) with a mating feature on the hub of the male luer connector.

In one or more embodiments of the second aspect of the present disclosure, the ball <NUM> forms an interference fit with inner wall of the cavity <NUM> of the cap <NUM>. In one or more embodiments, the ball <NUM> can be under radial compression by the plurality of ribs <NUM> on the inner surface of the cavity <NUM> to retain the ball <NUM> in the cavity <NUM>.

A third aspect of the present disclosure relates to a sterile cap <NUM>, as shown in <FIG> and <FIG>, a housing <NUM> comprises a top wall <NUM>, an essentially cylindrical sidewall <NUM> forming a cavity <NUM>, and an open bottom <NUM> formed by the cylindrical sidewall <NUM> with an opening to the cavity <NUM> within the housing <NUM> for receiving a hub of a connector of a medical device. The connector of the medical device may be a threaded connection, a needless connection, or in the preferred embodiment, a male luer connector. In one or more embodiments, the cavity includes a closed distal end comprising 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, a thread <NUM> is disposed on the outer surface <NUM> of the housing <NUM>, the thread <NUM> being sufficient to interlock with a mating feature of the male luer connector. In one or more embodiments, the thread may be formed as at least two tabs which may interlock with a twist-to-lock mating feature of the connector of the medical device. In further embodiments, the thread may be inclined or helical in shape, corresponding with the mating feature of the connector of the medical device intended to be sterilized.

A peelable seal <NUM> (not shown) may be in the form of a film and be provided to seal the open bottom <NUM> prior to use of the sterile cap <NUM>, by way of example, by attachment to a surface of a rim <NUM> of the open bottom <NUM>, The rim <NUM> may comprise a peripheral ledge extending radially outward from the sidewall <NUM> at the open bottom <NUM> defining an end face. The surface of rim <NUM> also defines an engagement surface where the sterile cap <NUM> may engage a mating surface of the male luer connector.

In one or more embodiments, the peelable seal <NUM> is disposed on the engagement surface of the rim <NUM> to prevent the disinfectant or the antimicrobial agent from exiting the cavity <NUM>. The peelable seal <NUM> minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the cap <NUM>, provides a leak prevention and protection enclosure, protects the contents contained within the cavity <NUM>, and/or maintains a sealed, sterilized environment. The peelable seal <NUM> provides a sufficient seal at a range of temperatures, pressures, and humidity levels. In one or more embodiments, the peelable seal <NUM> comprises an aluminum or multi-layer polymer film peel back top. In further embodiments, the peelable seal <NUM> is heat-sealed or induction sealed to the end face of the locking lid or to the cap open end. In one or more embodiments, the peelable seal <NUM> comprises a moisture barrier. The sterile cap <NUM> may achieve disinfection when used on common luer connectors by integrating disinfectant or antimicrobial agent or fluid <NUM> in the cavity <NUM> of the housing <NUM>.

In one or more embodiments, the cylindrical sidewall <NUM> defining the cavity may be tapered from the open bottom <NUM> towards the top wall <NUM>. In an alternative embodiment, the cylindrical sidewall <NUM> may include a plurality of parallel portions, the plurality of parallel portions varying in diameter. In one or more embodiments, the cylindrical sidewall <NUM> may include a plurality of parallel portions and a plurality of tapered portions, the plurality of parallel portions and the plurality of tapered portions varying in diameter.

As shown in <FIG>, in one or more embodiments, the sidewall <NUM> of the housing <NUM> comprises an upper portion 310A and a lower portion 310B. As shown in <FIG>, in one or more embodiments, the upper portion 310A of the sidewall <NUM> may have a smaller diameter than the diameter of the bottom portion 310B. In one or more embodiments, as shown in <FIG>, the upper portion 310A of housing <NUM> can include a tapered top portion having a top wall <NUM>. In one or more embodiments, the upper portion 310A of the sidewall of the housing can include a plurality of grip members <NUM>. In one or more embodiments, the plurality of grip members <NUM> taper outward.

Referring to <FIG>, the cylindrical sidewall <NUM> includes a first cylindrical portion <NUM>, an indented portion <NUM> and a second cylindrical portion <NUM>. A proximal end of the first cylindrical portion <NUM> is situated adjacent to the open bottom <NUM>. A distal end of the first cylindrical portion is disposed adjacent to a proximal end of the indented portion <NUM>. A proximal end of the second cylindrical portion <NUM> is disposed adjacent to a distal end of the indented portion <NUM>. In some embodiments, chamfered or rounded transitions may be disposed at the transitions from the first cylindrical portion <NUM> to the indented portion <NUM>, and from the indented portion <NUM> to the second cylindrical portion <NUM>. As depicted in <FIG>, a proximal chamfer <NUM> is disposed between the first cylindrical portion <NUM> and indented portion <NUM>, and a distal chamfer <NUM> is disposed between the indented portion <NUM> and the second cylindrical portion <NUM>.

As depicted in <FIG>, a ball <NUM> sits in the indented portion <NUM>. The indented portion <NUM> is defined by an arc <NUM> extending from the proximal chamfer <NUM> to the distal chamfer <NUM>. The arc diameter of the arc <NUM> is less than or equal to the diameter of the ball <NUM>, the arc <NUM> and the ball <NUM> being in an interference fit, the interference fit preventing any fluid or gas communication between the first cylindrical portion <NUM> and the second cylindrical portion <NUM>.

The first cylindrical portion <NUM> is defined by a tapered shape. The proximal diameter of the first cylindrical portion <NUM> is greater than or equal to the diameter of the ball <NUM>. The distal diameter of the first cylindrical portion <NUM> is approximately equal to the diameter of the ball <NUM>. Specifically, the distal diameter of the first cylindrical portion <NUM> is configured to prevent the ball <NUM> from inadvertently escaping the indented portion <NUM>. The proximal diameter of the first cylindrical portion <NUM> is often, but not necessarily, configured to create interference fit with a stem of a luer or needleless connection.

The second cylindrical portion <NUM> is defined by a proximal section <NUM> and a distal section <NUM>. The proximal section <NUM> has a diameter less than the diameter of the ball <NUM>. The proximal section <NUM> allows for the ball <NUM> to restrictedly travel through the proximal section <NUM> in a distal direction, the ball <NUM> and the proximal section <NUM> being in an interference fit. The distal section <NUM> having a diameter less than the diameter of ball <NUM>, preventing the ball <NUM> from traveling further in a distal direction. Alternatively, the distal section <NUM> may be tapered as to prevent the compressed ball <NUM> from traveling further in the distal direction.

The proximal section <NUM> of the second cylindrical portion <NUM> may further include a plurality of top flow channels <NUM> in which fluid flows through as the ball <NUM> is pushed within the proximal section <NUM>. The plurality of flow channels extend radially into the housing <NUM>. The plurality of top flow channels <NUM> extend from the distal chamfer <NUM> to the distal section <NUM>, the proximal and distal ends of the plurality of top flow channels <NUM> being tapered. The first cylindrical portion <NUM> may further include a plurality of bottom flow channels <NUM> in which fluid flows through as the ball <NUM> is pushed within the proximal section <NUM> of the second cylindrical portion <NUM>. When the ball <NUM> sits within the indented portion <NUM>, fluid or gas cannot flow from the plurality of top flow channels <NUM> to the plurality of bottom flow channels <NUM>, as the ball <NUM> is in an interference fit with the indented portion <NUM>. The plurality of bottom flow channels <NUM> is intended to promote disinfectant or antimicrobial agent permeation towards the mating surface of the male luer connector. Compression of the ball <NUM> toward the top wall <NUM> of housing <NUM> upon connection to the male luer connector allows the connector to contact the disinfectant or antimicrobial agent to disinfect the male luer connector.

As shown in <FIG> and <FIG>, an exemplary threaded male fitting <NUM> is depicted. The threaded male fitting <NUM> includes a lumen <NUM> disposed through a conical surface <NUM>, a mating feature having at least one thread <NUM>, and a mating surface <NUM> disposed at the bottom of the conical surface <NUM>. <FIG> and <FIG> illustrate the ball <NUM> compressed into the cap <NUM> by having engaged the thread <NUM> of the cap <NUM> onto the corresponding at least one thread <NUM> of the threaded male fitting <NUM>. The surface of the rim <NUM> of the cap <NUM> abuts the mating surface <NUM> of the threaded male fitting <NUM>. The ball <NUM> seals the lumen <NUM>, preventing disinfectant from entering a flow path of the threaded male fitting <NUM>.

In one or more embodiments of an exemplary cap <NUM>, as shown in <FIG>, a housing <NUM> comprises a top wall <NUM>, an essentially cylindrical sidewall <NUM> forming a cavity <NUM>, and an open bottom <NUM> formed by the cylindrical sidewall with an opening to the cavity <NUM> within the housing <NUM> for receiving a hub of a connector of a medical device. A thread <NUM> is disposed on the outer surface <NUM> of the housing <NUM>, the thread <NUM> being configured to interlock with a mating feature of the male luer connector. In one or more embodiments, the thread <NUM> may be formed as at least two tabs which may interlock with a twist-to-lock mating feature of the connector of the medical device. In further embodiments, the thread may be inclined or helical in shape, corresponding with the mating feature of the connector of the medical device intended to be sterilized. The essentially cylindrical sidewall <NUM> further comprises a rim <NUM>. The rim <NUM> protrudes from the open bottom <NUM> in a proximal direction. The rim <NUM> is configured to prevent excess disinfectant from spilling into a periphery of a luer connector upon full insertion of the cap <NUM>.

The cylindrical sidewall <NUM> includes a first cylindrical portion <NUM>, an indented portion <NUM> and a second cylindrical portion <NUM>. A proximal end of the first cylindrical portion <NUM> is situated adjacent to the open bottom <NUM>. A distal end of the first cylindrical portion is disposed adjacent to a proximal end of the indented portion <NUM>. A proximal end of the second cylindrical portion <NUM> is disposed adjacent to a distal end of the indented portion <NUM>. In some embodiments, chamfered or rounded transitions may be disposed at the transitions from the first cylindrical portion <NUM> to the indented portion <NUM>, and from the indented portion <NUM> to the second cylindrical portion <NUM>.

The proximal section <NUM> of the second cylindrical portion <NUM> further includes a plurality of top flow channels <NUM> in which fluid flows through as a ball is pushed within the proximal section <NUM>, as described in embodiments of the present invention. The plurality of top flow channels <NUM> extend radially into the housing <NUM>. The plurality of top flow channels <NUM> extend from the distal chamfer <NUM> to the distal section <NUM>, the proximal and distal ends of the plurality of top flow channels <NUM> being tapered. In one or more embodiments, the plurality of top flow channels <NUM> have a substantially rectangular cross-sectional shape.

In one or more embodiments, the first cylindrical portion <NUM> may further include a plurality of tabs <NUM> configured to have an interference fit with a hub of a male luer connector. The shape of the plurality of tabs <NUM> is sized to create sufficient resistance with the hub the male luer connector to prevent accidental or unintended removal of the cap <NUM> from the male luer connector. As shown in <FIG>, in one or more embodiments, the plurality of tabs <NUM> have a trapezoidal cross-sectional shape, wherein a proximal end of the trapezoidal cross-sectional shape is at a substantially right angle with the cylindrical sidewall <NUM>. In one or more embodiments, a distal end of the trapezoidal cross-sectional shape tapers in a distal direction 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 <NUM> is secured by the interference fit of the plurality of tabs <NUM>.

As shown in <FIG>, an exemplary threaded male fitting <NUM> is depicted. The threaded male fitting <NUM> includes a lumen <NUM> disposed through a distal tip <NUM> having a conical surface, a mating feature having at least one thread <NUM>, and a mating surface <NUM> disposed at the proximal end of the distal tip <NUM>. A ball <NUM> is compressed into the cap <NUM> by having engaged the thread <NUM> of the cap <NUM> onto the corresponding at least one thread <NUM> of the threaded male fitting <NUM>. In one or more embodiments, the surface of the rim <NUM> of the cap <NUM> may abut the mating surface <NUM> of the threaded male fitting <NUM>, thereby preventing excess disinfectant from escaping. As previously described in embodiments of the present invention, the ball <NUM> seals the lumen <NUM>, preventing disinfectant from entering a flow path of the threaded male fitting <NUM>, the disinfectant being stored within the cavity <NUM> behind the ball <NUM>. The disinfectant disinfects the conical surface of the hub <NUM> and the periphery of the threaded male fitting. The plurality of tapered tabs <NUM> form a drafted sidewall surface configured to have an interference fit with a hub of a male luer connector. In one or more embodiments, the plurality of tapered tabs <NUM> are disposed on the inner surface of the sidewall at the open end of the cap to form a longitudinal draft configured to have an interference fit with a hub of a male luer connector.

In one or more embodiments of an exemplary cap <NUM>, as shown in <FIG>, a housing <NUM> comprises a top wall <NUM>, an essentially cylindrical sidewall <NUM> forming a cavity <NUM>, and an open bottom <NUM> formed by the cylindrical sidewall with an opening to the cavity <NUM> within the housing <NUM> for receiving a hub of a connector of a medical device. A thread <NUM> is disposed on the outer surface <NUM> of the housing <NUM>, the thread <NUM> being configured to interlock with a mating feature of the male luer connector. In one or more embodiments, the thread <NUM> may be formed as at least two tabs which may interlock with a twist-to-lock mating feature of the connector of the medical device. In further embodiments, the thread may be inclined or helical in shape, corresponding with the mating feature of the connector of the medical device intended to be sterilized The essentially cylindrical sidewall <NUM> further comprises a rim <NUM>. The rim <NUM> protrudes from the open bottom <NUM> in a proximal direction. The rim <NUM> is configured to prevent excess disinfectant from spilling into a periphery of a luer connector upon full insertion of the cap <NUM>.

In one or more embodiments, the first cylindrical portion <NUM> may further include a plurality of bottom flow channels <NUM> in which fluid flows through as the ball is pushed within the proximal section <NUM> of the second cylindrical portion <NUM>. When the ball sits within the indented portion <NUM>, fluid or gas cannot flow from the plurality of top flow channels <NUM> to the plurality of bottom flow channels <NUM>, as the ball is in an interference fit with the indented portion <NUM>. The plurality of bottom flow channels <NUM> is intended to promote disinfectant or antimicrobial agent permeation towards the mating surface of the male luer connector. Compression of the ball toward the top wall <NUM> of housing <NUM> upon connection to the male luer connector allows the connector to contact the disinfectant or antimicrobial agent to disinfect the male luer connector. In one or more embodiments, the top flow channels <NUM> and bottom flow channels <NUM> have the same cross-sectional shape and width.

As shown in <FIG>, an exemplary threaded male fitting <NUM> is depicted. The threaded male fitting <NUM> includes a lumen <NUM> disposed through a hub <NUM> having a conical surface, a mating feature having at least one thread <NUM>, and a mating surface <NUM> disposed at the proximal end of the hub <NUM>. A ball <NUM> is compressed into the cap <NUM> by having engaged the thread <NUM> of the cap <NUM> onto the corresponding at least one thread <NUM> of the threaded male fitting <NUM>. In one or more embodiments, the surface of the rim <NUM> of the cap <NUM> may abut the mating surface <NUM> of the threaded male fitting <NUM>, thereby preventing excess disinfectant from escaping. As previously described in embodiments of the present invention, the ball <NUM> seals the lumen <NUM>, preventing disinfectant from entering a flow path of the threaded male fitting <NUM>, the disinfectant being stored within the cavity <NUM> behind the ball <NUM>. The disinfectant disinfects the conical surface of the hub <NUM> and the periphery of the threaded male fitting. The inside surface of the open bottom <NUM> includes a drafted sidewall surface configured to have an interference fit with a hub of a male luer connector. In one or more embodiments, the drafted sidewall surface are radially tapered outward toward the center axis of the cavity to form a longitudinal draft configured to have an interference fit with a hub of a male luer connector.

In one or more embodiments, an open bottom <NUM> formed by a cylindrical sidewall with an opening to a cavity within the housing for receiving a hub of a connector of a medical device has a taper <NUM> which tapers outwardly from the cylindrical sidewall towards the opening to the cavity. In one or more embodiments, the taper <NUM> is located between <NUM> to <NUM> from the open bottom.

In one or more embodiments, an indented portion <NUM> positioned adjacent to a proximal cylindrical portion <NUM> is defined by an arc <NUM>. The arc <NUM> has an arc angle R between <NUM> degrees and <NUM> degrees and a center C of the arc angle is positioned between <NUM> and <NUM> from the opening to the cavity. The arc has a proximal starting position 387a and a distal ending position. At the proximal starting position 378a, a diameter D of the cavity is between <NUM> and <NUM>.

Referring to <FIG>, in one or more embodiments, the exterior surface of sidewall (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprises a plurality of grip members (<NUM>, <NUM>, <NUM>). In one or more embodiments, the plurality of grip members (<NUM>, <NUM>, <NUM>) are in the form of elongate ribs. A fourth aspect of the present disclosure, as shown in <FIG> and <FIG>, pertains to a relates to a sterile cap <NUM>, a housing <NUM> comprises a top wall <NUM>, an essentially cylindrical sidewall <NUM> forming a cavity <NUM>, and an open bottom <NUM> formed by the cylindrical sidewall <NUM> with an opening to the cavity <NUM> within the housing <NUM> 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 the preferred embodiment, a male luer connector. In one or more embodiments, the cavity includes a closed distal end comprising 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, a thread <NUM> is disposed on the outer surface <NUM> of the housing <NUM>, the thread <NUM> being sufficient to interlock with a mating feature of the male luer connector. In one or more embodiments, the thread may be formed as at least two tabs which may interlock with a twist-to-lock mating feature of the connector of the medical device. In further embodiments, the thread may be inclined or helical in shape, corresponding with the mating feature of the connector of the medical device intended to be sterilized. Referring to <FIG>, in one or more embodiments, cap <NUM> includes an absorbent material <NUM> disposed within the cavity behind the ball <NUM>. In one or more embodiments, the disinfectant or antimicrobial agent in the cavity <NUM> of the cap <NUM> is stored by the absorbent material <NUM> with the ball <NUM> over the absorbent material <NUM> for sealing. In one or more embodiments, the disinfectant or antimicrobial agent disinfects an outer surface and an inner surface of the male luer connector when the male luer connector is inserted into the cavity and compresses the ball and the absorbent material <NUM> disposed behind the ball <NUM>. In one or more embodiments, the absorbent material <NUM> is a nonwoven material, foam or a sponge. In one or more embodiments, the absorbent material is an open-cell sponge. In a specific embodiment, the foam is a polyurethane foam. In one or more embodiments, the absorbent material is retained in the chamber by an interference fit with the inner sidewall of the chamber. When the cap <NUM> is attached to a luer device, the male luer pushes against the ball <NUM> to displace the ball <NUM> toward closed end of the cap housing, with the ball <NUM> compressing the absorbent material <NUM> to release disinfectant onto luer surface.

In one or more embodiments, a compression of the absorbent material toward the top wall of the housing occurs upon connection of the disinfection cap to a luer connector, whereby compression of the absorbent material leads to the leakage of the disinfectant or antimicrobial agent within the cavity to disinfect the luer connector. The cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). The disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) can be directly included in the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). Cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is designed to be compatible in interacting with various disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>). In one or more embodiments, the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) is selected from the group consisting essentially of isopropyl alcohol, ethanol, <NUM>-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) is a fluid or a gel.

In one or more embodiments, the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) can include a removable peel seal (<NUM>, <NUM>, <NUM>) covering the opening to the cavity (<NUM>, <NUM>, <NUM>) to seal the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) within the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) prior to use of the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). In one or more embodiments, the peelable seal (<NUM>, <NUM>, <NUM>) comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the peelable seal (<NUM>, <NUM>, <NUM>) is heat-sealed or induction sealed to the open end of the cap (<NUM>, <NUM>, <NUM>). In one or more embodiments, the peelable seal (<NUM>, <NUM>, <NUM>) comprises a moisture barrier.

In the preferred embodiment the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) can be compressible and may be a thermoplastic elastomer ("TPE"), thermoplastic olefin ("TPO"), or an elastomer or deformable material. In other embodiments, the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) may be of a rigid or hard plastic causing the housing (<NUM>, <NUM>, <NUM>) to deform. In further embodiments, the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) may be glass, ceramic, metal or a composite material.

In one or more embodiments, the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>) disinfects an outer surface or periphery of the male luer connector when the male luer connector is inserted into the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and pushes the ball in a distal direction. In the preferred embodiment, the insertion compresses the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). The ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) forms an interference fit with an inner wall of the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>). In one or more embodiments, the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is soft and can form slight clearance with inner sidewall of the cavity (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) when subject to pressure.

The cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) is 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 cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) comprises a polypropylene or polyethylene material.

In one or more embodiments, the connector of the medical device may be selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors on primary IV gravity sets, secondary IV gravity sets, extension sets, and infusion or syringe pump sets. In some embodiments, the cap can be connected with any of a variety of different needleless injection sites. In one or more embodiments, after the cap has been coupled with connector, it is unnecessary to disinfect (e.g. treat with an alcohol swab) the connector prior to each reconnection of the connector with another connector, as the connector will be kept in an uncontaminated state while coupled with the cap. Use of the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) replaces the standard swabbing protocol for cleaning connectors.

A fifth aspect of the present disclosure pertains to a method of disinfecting a medical connector. The method comprises connecting the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of one or more embodiments to a medical connector, wherein connecting includes engaging the threads of the medical connector onto the threads (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) on the outer surface of the sidewall (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of the housing (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of the cap upon insertion of the medical connector into the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) such that the medical connector contacts the ball (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) and the disinfectant or antimicrobial agent (<NUM>, <NUM>, <NUM>).

A sixth aspect of the present disclosure pertains to an assembly. The assembly comprises the cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) of one or more embodiments 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 needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors.

A seventh aspect of the present disclosure pertains to packaging. Referring to <FIG>, in one or more embodiments, cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) can be packaged into a strip configuration. As shown in <FIG>, the strip configuration may comprise a single-piece top web <NUM> on which multiple caps (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) are attached through a sealing layer. The strip configuration may also comprise individually sealed caps with individual top web foil, and then a series of individually sealed caps are attached to a piece of strip composed of materials such as plastic in an arrayed fashion. The individual top web foil can have a tab that is attached to the strip material through adhesive or through sealant.

It is contemplated that the disinfection cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>) disclosed herein and shown in the Figures may also be utilized with female connectors, including female luer connectors, wherein ball (<NUM>, <NUM><NUM>, <NUM>, <NUM>, <NUM>) can be used to block the lumen of open female luers to facilitate the mitigation of such disinfectant ingress into connectors, thereby reducing risk of the disinfectant entering the blood stream. It is therefore contemplated that the disinfection cap (<NUM>, <NUM>, <NUM>, <NUM>, <NUM>) disclosed herein and shown in the Figures may be utilized with both male and female connectors.

While the present disclosure has been shown and described with reference to certain exemplary embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the scope of the embodiments of the present disclosure. Also, the inner and/or the outer housing of the cap can be single shot molded, or made by other suitable process. Furthermore, any of the features or elements of any exemplary implementations of the embodiments of the present disclosure as described above and illustrated in the drawing figures can be implemented individually or in any combination(s) as would be readily appreciated by skilled artisans without departing from the scope of the embodiments of the present disclosure.

In addition, the included drawing figures further describe non-limiting examples of implementations of certain exemplary embodiments of the present disclosure and aid in the description of technology associated therewith. Any specific or relative dimensions or measurements provided in the drawings other as noted above are exemplary and not intended to limit the scope or content of the inventive design or methodology as understood by artisans skilled in the relevant field of invention.

Other objects, advantages and salient features of the disclosure will become apparent to those skilled in the art from the details provided, which, taken in conjunction with the annexed drawing figures, disclose exemplary embodiments of the disclosure.

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

Claim 1:
A cap <NUM> comprising:
a housing <NUM> comprising
a top wall <NUM>,
an essentially cylindrical sidewall <NUM> having an inner surface <NUM> defining a cavity <NUM>,
an open bottom <NUM> formed by said cylindrical sidewall <NUM> with an opening to the cavity <NUM> within said housing for receiving a hub of a male luer connector;
an outer thread <NUM> on said outer surface of the cylindrical sidewall <NUM>, said outer thread <NUM> being sufficient to interlock with a mating feature of said male luer connector;
a ball <NUM> disposed within the cavity;
a disinfectant or antimicrobial agent,
characterized by:
one or more ribs <NUM> disposed on an inner surface of the cavity <NUM>;
the cavity <NUM> having an inner surface <NUM> having a first portion adjacent to the open bottom <NUM> having a straight cylindrical sidewall having a first diameter D1 which is smaller than the diameter of the ball <NUM>, a second tapered portion disposed adjacent to the first portion wherein the second tapered portion having a second diameter D2 that increases along the y-axis in a direction from the open bottom <NUM> toward a top wall <NUM> of the cavity <NUM>, and a third portion having a straight cylindrical sidewall having a plurality of ribs <NUM> protruding toward the central axis of the cavity, the third portion of the inner surface of the cavity disposed adjacent to the second portion and having diameter D3 that is equal to or greater than the diameter of the ball.