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 hubs and ports/valves upon connection to the VAD to deliver the fluid or pharmaceutical. Each access hub (or port/valve or connection) is associated with some risk of transmitting a catheter related bloodstream infection (CRBSI), which can be costly and potentially lethal.

In order to decrease catheter-related bloodstream infection (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 early indications are that caps will also be incorporated into the <NUM> 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 the CRBSI events described before. Nurses will typically utilize a <NUM>% IPA alcohol pad to complete this disinfection task by doing what is known as "scrubbing the hub. " However, compliance to this practice is typically very low. In addition to a lack of compliance to "scrubbing the hub", it has also been noted through clinician interviews that there is often a variation in scrub time, dry time and the number of times the needleless connector is scrubbed.

Throughout the sequence of procedures associated with the transmission of a microorganism that can cause a CRBSI, there are many risks of contact or contamination. Contamination can occur during drug mixing, attachment of a cannula, and insertion into the access hub. Because the procedure to connect to a VAD is so common and simple, the risk associated with entry into a patient'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.

Currently, caps for male needleless connectors, female needleless connectors, intravenous (IV), and hemodialysis lines use different designs and are therefore limited to the types of connectors to which the cap can be attached. Prior disinfecting caps were designed to fit one type of connector only, and were specific to one particular size and/or shape of connector. Thus, there is a need for a disinfecting device capable of accommodating multiple types of connectors to streamline the disinfecting process. There is also a need for a disinfecting device capable of continuous disinfection for multiple days. <CIT>, <CIT> and <CIT> describe prior art disinfecting caps adapted to engage male and female luer connectors.

One aspect of the present disclosure pertains to a device for connection to a medical connector. The device generally comprises an outer cap, an inner cap, and a peelable seal. In one or more embodiments, the outer cap comprises an integral body, a closed end, and an annular wall having a length extending from the closed end to an open end defining a chamber. The chamber may contain an absorbent material and disinfectant or antimicrobial agent. The open end of the outer cap defines an end face. The annular wall of the outer cap includes an outer cap exterior wall surface and an outer cap interior wall surface. The interior wall surface includes one or more threads. The inner cap includes an integral body having an annular wall having an exterior wall surface and an interior wall surface with a first end of the inner cap facing the closed end of the outer cap, a second end of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes one or more threads which may engage with the threads on the interior wall surface of the outer cap. The exterior wall surface of the second end of the inner cap includes one or more threads adapted to engage a male luer connector. When the threads of the inner cap are engaged with a male luer connector, the threads of the outer cap will be passive. Alternatively, when the threads of the outer cap are engaged with a female luer connector, the threads of the inner cap will be passive. In one or embodiments, the peelable seal may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

When the device is removed from its packaging, the open end of the outer cap is situated on a same horizontal plane as the second end of the inner cap in an initial state. To connect the device to a male luer connector, the user applies an axial load such that a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the inner cap partially protrude out from the open end of the outer cap. When the inner cap partially protrudes out from the open end of the outer cap, there is no space that exists between the device and the connector. When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a counter-clockwise direction, the inner cap retracts into the chamber of the outer cap. When a female luer connector is engaged to the device, the inner cap slips and retracts into the chamber of the outer cap. Once the device is engaged to the connector, the device may be removed from the connector by rotating the device counter-clockwise. Upon disengagement, the inner cap and the outer cap remain intact and attached to each other.

The device is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. The disinfectant or antimicrobial agent can be a fluid or a gel 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 embodiments, the outer cap exterior wall surface includes a plurality of grip members.

In one or more embodiments, the female connector may be a needle-free connector, stopcock, or hemodialysis connector. In one or more embodiments, the male connector may be an intravenous tubing end or stopcock.

The present invention pertains to a device for connection to a medical connector which generally comprises an outer cap, an inner cap, and a peelable seal.

The outer cap comprises a body, a closed end, an annular wall having a length extending from the closed end to an open end and defining a chamber containing an absorbent material and disinfectant or antimicrobial agent. The open end defines an end face. Annular wall of the outer cap includes an outer cap exterior wall surface and an outer cap interior wall surface. The outer cap interior wall surface comprises one or more grooves and one or more threads adapted to engage with a female luer connector. In one or more embodiments, the female connectors may be in the form of needle-free connectors, stopcocks, and hemodialysis connectors. In one or more alternate embodiments, the body of the outer cap may be comprised of two components, where a rear-end component with an inner cavity is screwed onto the front-end component of the cap body via threads or welding.

The inner cap comprises a body having an annular wall having an exterior wall surface and an interior wall surface with a first end of the inner cap facing the closed end of the outer cap. A second end of the inner cap faces the open end of the outer cap. The outer cap interior wall surface comprises one or more grooves along which the inner cap is able to slide. The exterior wall surface of the first end of the inner cap includes two shaft-like wings to fit into the one or more grooves of the outer cap interior wall surface to facilitate the slide motion without allowing signification relative rotation between the inner cap with respect to the outer cap. The outer-most diameter of the threads of the inner cap is designed to have minimum interference, e.g. sliding fit or strip fit, with the threads of the outer cap to allow relative linear motion and also facilitate assembly of device. The teeth depth of the threads of the inner cap and the outer cap is desired to be sufficient to engage with the male and female luer connectors. The exterior wall surface of the second end of the inner cap includes one or more thread-tabs adapted to engage a male luer connector. In one or more embodiments, the exterior wall surface of the second end of the inner cap includes two thread-tabs adapted to engage a male luer connector. The male luer connectors include collars with female threads. In one or more embodiments, the male connector can be an intravenous (I. ) tubing end, stopcock or male lock luer.

Inner cap can slide back and forth with respect to outer cap. In one or more embodiments, the open end of the outer cap is situated on a same horizontal plane as the second end of the inner cap in an initial state. When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap, the inner cap slides against the outer cap to partially protrude out from the open end of the outer cap. When a female luer connector is engaged to the device, the inner cap slides against the outer cap and retracts into the chamber of the outer cap to allow the female luer connector to engage the one or more threads on the interior wall surface of the outer cap.

Disinfecting caps currently on the market are capable of only disinfecting one of the three types of luer fitting, namely female luer of needle-free connectors, female luer of stopcocks, and male luer connectors on intravenous injection sites. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, the device is self-adaptive to different types of luer connectors due to the sliding mechanism between the inner cap that engages with male luer connectors and the outer cap that engages with female luer connectors, thereby allowing the user to clean different types of connectors with a single device. Upon mounting the outer cap onto female luer connectors, the inner cap retreats towards the chamber at the closed end of the outer cap, thus, providing space for female luer connectors to be inserted and screwed onto the threads of the outer cap. Upon mounting the inner cap of device onto a male luer connector, the one or more thread-tabs on the exterior wall surface of the second end of the inner cap engage with the threads on the male luer connector. Hence, the disclosed cap can be mounted onto both male and female luers.

The device can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the chamber of the outer cap. The disinfectant or antimicrobial agent can be directly included in the chamber or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of outer cap. In one or more embodiments, the disinfectant or antimicrobial agent 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.

The peelable seal on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

The outer-most diameter of the one or more thread-tabs of the inner cap has a minimum interference with the threads of the outer cap to allow for relative linear motion.

The present invention also pertains to a device for connection to a medical connector which generally comprises an outer cap, an inner cap, and a peelable seal.

The outer cap comprises an integral body, a closed end, an annular wall having a length extending from the closed end to an open end and defining a chamber containing an absorbent material and disinfectant or antimicrobial agent. The open end defines an end face.

The annular wall of the outer cap comprises an outer cap exterior wall surface and an outer cap interior wall surface. The outer cap interior wall surface includes one or more grooves and one or more threads adapted to engage with a female luer connector, wherein at least a portion of said one or more threads on the outer cap interior wall surface comprise a gap that does not engage a mating feature of the inner cap.

The inner cap slidably engages with the outer cap. The inner cap comprises an integral body having an annular wall having an exterior wall surface and an interior wall surface with a first end of the inner cap facing the closed end of the outer cap and a second end of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes two shaft-like wings to fit into the one or more grooves of the outer cap interior wall surface and facilitate the slide motion without allowing signification relative rotation between the inner cap with respect to the outer cap. The exterior wall surface of the second end of the inner cap includes one or more thread-tabs adapted to engage a male luer connector. The inner cap is in a slidable arrangement with the outer cap.

In one or more embodiments, the open end of the outer cap is situated on a same horizontal plane as the second end of the inner cap in an initial state.

When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the inner cap partially protrude out from the open end of the outer cap.

When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a counter-clockwise direction, the inner cap retracts into the chamber of the outer cap.

When a female luer connector is engaged to the device, the inner cap slides against the outer cap and retracts into the chamber of the outer cap to allow the female luer connector to engage the one or more threads on thee the interior wall surface of the outer cap.

In one or more embodiments, the exterior wall surface of the second end of the inner cap includes two thread-tabs adapted to engage a male luer connector having collars with female threads.

In one or more embodiments, the female connector may be selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors.

In one or more embodiments, the male connector may be an intravenous tubing end, stopcock or male lock luer.

In one or more embodiments, the threads of the inner cap and the threads of the outer cap are void of interference to enable a sliding fit.

In one or more embodiments, the gaps of the one or more threads of the outer cap interior wall surface are disposed adjacent to the grooves of the outer cap interior wall surface to allow sliding of the inner cap against the outer cap.

The gaps of the one or more threads of the outer cap interior wall surface accommodate the one or more thread-tabs on the exterior wall surface of the second end of the inner cap when the inner cap slides against the outer cap.

In one or more embodiments, the two shaft-like wings on the exterior wall surface of the first end of the inner cap further comprise one or more pockets having a snap-fit arrangement with one or more protrusions disposed on the one or more grooves of the outer cap interior wall surface to fix the position of the inner cap with the outer cap.

When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the one or more pockets on the two shaft-like wings of the inner cap disengage from the one or more protrusions on the outer cap interior wall surface to allow the inner cap to partially protrude out from the opening end of the outer cap.

When a female luer connector is engaged to the device, the inner cap will be pushed and the one or more pockets on the two shaft-like wings of the inner cap disengage from the one or more protrusions on the outer cap interior wall surface to allow the inner cap to move toward the closed end of the chamber.

In one or more embodiments, the two shaft-like wings on the exterior wall surface of the first end of the inner cap further comprise one or more protrusions having a snap-fit arrangement with one or more corresponding one or more pockets disposed on the one or more grooves of the outer cap interior wall surface to fix the position of the inner cap with the outer cap.

When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the one or more pockets on the two shaft-like wings of the inner cap disengages from the one or more protrusions on the outer cap interior wall surface to allow the inner cap to partially protrude out from the opening end of the outer cap.

Inner cap can slide back and forth with respect to outer cap. In one or more embodiments, the open end of the outer cap is situated on a same horizontal plane as the second end of the inner cap in an initial state. When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap, the inner cap slides against the outer cap to partially protrude out from the open end of the outer cap. When a female luer connector is engaged to the device, the inner cap slides against the outer cap and retracts into the chamber of the outer cap to allow the female luer connector to engage the one or more threads on the interior wall surface of the outer cap. The threads of the inner cap and the threads of the outer cap are intrinsically non-interfering with each other, and are no longer restrained by interference that enables sliding fit.

Disinfecting caps currently on the market are capable of only disinfecting one of the three types of luer fitting, namely female luer of needle-free connectors, female luer of stopcocks, and male luer connectors on intravenous injection sites. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, device is self-adaptive to different types of luer connectors due to the sliding mechanism between the inner cap that engages with male luer connectors and the outer cap that engages with female luer connectors thereby allowing the user to clean different types of connectors with a single device. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, device and other embodiments of the present disclosure provides a single device to be used for cleaning different types of connectors. Upon mounting the outer cap onto female luer connectors, the inner cap retreats towards the chamber at the closed end of the outer cap, thus, providing space for female luer connectors to be inserted and screwed onto the threads of the outer cap. Upon mounting the inner cap of device onto a male luer connector, the one or more thread-tabs on the exterior wall surface of the second end of the inner cap engage with the threads on the male luer connector. Hence the disclosed cap can be mounted onto both male and female luers. The threads of the inner cap and the threads of the outer cap have little or no interference with each other, and the dimension of the threads of the inner cap and the threads of the outer cap are independent with each other while meeting the luer standard.

The device can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the chamber of the outer cap. The disinfectant or antimicrobial agent can be directly included in the chamber or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting 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 embodiments, the disinfectant or antimicrobial agent may be a fluid or a gel. In one or more embodiments, the absorbent material compresses toward the closed end of the chamber upon connection to the female luer connector or the male luer connector. The compression of the absorbent material disinfects the female luer connector or the male luer connector.

Another aspect of the present disclosure pertains to a device for connection to a medical connector which generally comprises an outer cap, an inner cap, and a peelable seal.

The outer cap comprises an integral body, a closed end, an annular wall having a length extending from the closed end to an open end and defining a chamber containing an absorbent material and disinfectant or antimicrobial agent. The open end of the outer cap defines an end face.

The annular wall of the outer cap comprises an outer cap exterior wall surface and an outer cap interior wall surface. The outer cap interior wall surface includes one or more pockets.

The inner cap comprises an integral body having an annular wall having an exterior wall surface and an interior wall surface with a first end of the inner cap facing the closed end of the outer cap, a second end of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes a flexure hinge adapted to engage the one or more pockets of the interior wall surface of the outer cap to fix the position of the inner cap with the outer cap. The exterior wall surface of the second end of the inner cap includes one or more threads adapted to engage a male luer connector.

In one or more embodiments, when a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the flexure hinge on the inner cap disengages from the pocket on the outer cap interior wall surface to allow the inner cap to partially protrude out from the opening end of the outer cap.

In one or more embodiments, when a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a counter-clockwise direction, the inner cap retracts into the chamber of the outer cap.

In one or more embodiments, when a female luer connector is engaged to the device, the inner cap will be pushed and the interlocking between the flexure hinge on the inner cap and the pocket on the outer cap will be dislodged to allow the inner cap to move toward the closed end of the chamber.

In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting 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 embodiments, the female luer connector is selected from the group consisting of needle-free connectors, stopcocks, and hemodialysis connectors.

In one or more embodiments, the male luer connector may be an intravenous tubing end, stopcock or male lock luer.

The outer cap comprises an integral body, a closed end, an annular wall having a length extending from the closed end to an open end and defining a chamber containing an absorbent material and disinfectant or antimicrobial agent. The open end of the annular wall defines an end face. In one or more embodiments, the annular wall comprises a flared curvature at the open end of the body defining an end face. The annular wall of the outer cap comprises an outer cap exterior wall surface and an outer cap interior wall surface, the interior wall surface having one or more protrusions. The inner cap comprises an integral body having an annular wall having an exterior wall surface and an interior wall surface with a first end of the inner cap facing the closed end of the outer cap, a second end of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes a dimple adapted to engage the one or more protrusions of the interior wall surface of the outer cap to fix the position of the inner cap with the outer cap. The exterior wall surface of the second end of the inner cap includes one or more thread-tabs adapted to engage a male luer connector. The peelable seal on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

In one or more embodiments, the outer cap exterior wall surface can include indicia, graphics, symbols, diagrams, words or other instructions.

In one or more embodiments, the open end of the outer cap may be situated on a same horizontal plane as the second end of the inner cap in an initial state.

When a female luer connector is engaged to the device, the inner cap slips and retracts into the chamber of the outer cap.

In one or more embodiments, the female connector is selected from the group consisting of needle-free connectors, stopcocks, and hemodialysis connectors.

In one or more embodiments, the male connector may be an intravenous tubing end, stopcock or a male lock luer.

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.

Embodiments of the disclosure pertain to a universal single-use device for connection to and disinfection of a medical connector, including male luer connectors and female luer connectors, in which the device comprises an outer cap and inner luer. The device provides a mechanical barrier for connectors and contains an antimicrobial agent for disinfection. The device of the present disclosure allows the practitioner to streamline the disinfecting process.

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

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

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

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

Referring to <FIG>, a device <NUM> for connection to a medical connector generally comprises an outer cap <NUM>, an inner cap <NUM>, and a peelable seal <NUM>. As shown in <FIG> and <FIG>, the outer cap <NUM> comprises an integral body <NUM>, a closed end <NUM>, and an outer cap annular wall <NUM> having a length L<NUM> extending from the closed end <NUM> to an open end <NUM> defining a chamber <NUM>. The chamber <NUM> may contain an absorbent material <NUM> and disinfectant or antimicrobial agent. The open end <NUM> of the outer cap <NUM> defines an end face <NUM>. The annular wall <NUM> of the outer cap <NUM> includes an outer cap exterior wall surface <NUM> and an outer cap interior wall surface <NUM>. The outer cap interior wall surface <NUM> includes one or more threads <NUM> adapted to engage a female luer connector. The inner cap <NUM> includes an integral body <NUM> having an annular wall <NUM> having an exterior wall surface <NUM> and an interior wall surface <NUM> with a first end <NUM> of the inner cap facing the closed end <NUM> of the outer cap <NUM>, a second end <NUM> of the inner cap facing the open end <NUM> of the outer cap <NUM>. The inner cap annular wall <NUM> having a length LI1 extending from the first end <NUM> to the second end <NUM> and being less than the length LO1 of the outer cap. The exterior wall surface <NUM> of the first end <NUM> of the inner cap <NUM> includes one or more threads <NUM> to engage with the threads <NUM> on the interior wall surface <NUM> of the outer cap <NUM>. The exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes one or more threads <NUM> adapted to engage a male luer connector. When the threads of the inner cap are engaged with a male luer connector, the threads of the outer cap will be passive. Alternatively, when the threads of the outer cap are engaged with a female luer connector, the threads of the inner cap will be passive. In one or more embodiments, the peelable seal <NUM> may be placed on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber <NUM>. In one or more embodiments, the peelable seal comprises an aluminum or multi-layer polymer film peel back top. In one or more embodiments, the peelable seal <NUM> comprises a moisture barrier.

When device <NUM> is removed from its packaging, the open end <NUM> of the outer cap <NUM> is situated on approximately a same horizontal plane P as the second end <NUM> of the inner cap <NUM> in an initial state. As used herein, the use of the phrase "approximately a same horizontal plane P" refers to a position in which the outer cap and the inner cap are close to each other but the inner cap does not protrude relative to the outer cap. To connect the device to a male luer connector, the user applies an axial load such that a male luer connector is engaged to the one or more threads <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a clockwise direction, the inner cap <NUM> partially protrudes out from the open end of the outer cap. When the inner cap <NUM> partially protrudes out from the open end <NUM> of the outer cap <NUM>, there is no space that exists between the device and the connector. When a male luer connector is engaged to the one or more threads <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a counter-clockwise direction, the inner cap <NUM> retracts into the chamber <NUM> of the outer cap <NUM>. In one or more embodiments, male luer connector can be detached from device <NUM> by counter-clockwise rotation without forcing inner cap <NUM> to retract. When a female luer connector is engaged to the device, the inner cap <NUM> slips and retracts into the chamber <NUM> of the outer cap <NUM>. Once the device is engage to the connector, the device may be removed from the connector by rotating the device counter-clockwise. Upon disengagement, the inner cap <NUM> and the outer cap <NUM> remain intact and attached to each other.

Device <NUM> is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. The disinfectant or antimicrobial agent can be a fluid or a gel 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 embodiments, the absorbent material compresses toward the closed end of the chamber upon connection to the female luer connector or the male luer connector. The compression of the absorbent material disinfects the female luer connector or the male luer connector.

The inner cap <NUM> and/or the outer cap <NUM> is made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.

In one or more embodiments, the outer cap exterior wall surface <NUM> includes a plurality of grip members <NUM>.

In one or more embodiments, the female connector may be a needle-free connector, stopcock, or hemodialysis connector. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall, Nexus, InVision, Vadsite, Bionector, etc. In one or more embodiments, the male connector may be an intravenous tubing end or stopcock.

Referring to <FIG>, a device <NUM> for connection to a medical connector according to the present invention comprises an outer cap <NUM>, an inner cap <NUM>, and a peelable seal. As discussed further herein, device <NUM> can fit a broad range of luer fitting, including closed female luer, open female luer, and male luer fittings, while is capable of disinfecting the medical implement such as access ports including needleless connectors, male connectors on intravenous lines, stopcocks, and hemodialysis connectors. The inner cap <NUM> is in a slidable arrangement with the outer cap <NUM>.

As shown in <FIG>, the outer cap <NUM> comprises a body <NUM>, a closed end <NUM>, an outer cap annular wall <NUM> having a length LO2 extending from the closed end <NUM> to an open end <NUM> and defining a chamber <NUM> containing an absorbent material and disinfectant or antimicrobial agent. The open end <NUM> defines an end face <NUM>. Outer cap annular wall <NUM> includes an outer cap exterior wall surface <NUM> and an outer cap interior wall surface <NUM>. The outer cap interior wall surface <NUM> comprises one or more grooves <NUM> and one or more threads <NUM> adapted to engage with a female luer connector. In one or more embodiments, the female connectors may be in the form of needle-free connectors, stopcocks, and hemodialysis connectors. In one or more alternate embodiments, as shown in <FIG>,the body <NUM> of the outer cap <NUM> may be comprised of two components, where a rear-end component with an inner cavity is screwed onto the front-end component of the cap body via threads or welding.

The inner cap <NUM> comprises a body <NUM> having an annular wall <NUM> having an exterior wall surface <NUM> and an interior wall surface <NUM> with a first end <NUM> of the inner cap facing the closed end <NUM> of the outer cap <NUM>. A second end <NUM> of the inner cap <NUM> faces the open end <NUM> of the outer cap <NUM>. The outer cap interior wall surface <NUM> comprises one or more grooves <NUM> along which the inner cap <NUM> is able to slide. The exterior wall surface <NUM> of the first end <NUM> of the inner cap <NUM> includes two shaft-like wings <NUM> to fit into the one or more grooves <NUM> of the outer cap interior wall surface <NUM> and facilitate the slide motion without allowing signification relative rotation between the inner cap <NUM> with respect to the outer cap <NUM>. The outer-most diameter of the threads of the inner cap is designed to have minimum interference, e.g. sliding fit or strip fit, with the threads of the outer cap to allow relative linear motion and also facilitate assembly of device <NUM>. The teeth depth of the threads of the inner cap and the outer cap is desired to be sufficient to engage with the male and female luer connectors. The exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes one or more thread-tabs <NUM> adapted to engage a male luer connector. In one or more embodiments, the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes two thread-tabs <NUM> adapted to engage a male luer connector. The male luer connectors include collars with female threads. In one or more embodiments, the male connector can be an intravenous (I. ) tubing end, stopcock or male lock luer.

Inner cap <NUM> can slide back and forth with respect to outer cap <NUM>. In one or more embodiments, the open end <NUM> of the outer cap <NUM> is situated on a same horizontal plane P as the second end <NUM> of the inner cap <NUM> in an initial state. When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM>, the inner cap <NUM> slides against the outer cap <NUM> to partially protrude out from the open end <NUM> of the outer cap <NUM>. When a female luer connector is engaged to device <NUM>, the inner cap <NUM> slides against the outer cap <NUM> and retracts into the chamber <NUM> of the outer cap <NUM> to allow the female luer connector to engage the one or more threads <NUM> on the interior wall surface <NUM> of the outer cap <NUM>.

Disinfecting caps currently on the market are capable of only disinfecting one of the three types of luer fitting, namely female luer of needle-free connectors, female luer of stopcocks, and male luer connectors on intravenous injection sites. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, device <NUM> is self-adaptive to different types of luer connectors due to the sliding mechanism between the inner cap that engages with male luer connectors and the outer cap that engages with female luer connectors thereby allowing the user to clean different types of connectors with a single device. As discussed above, upon mounting the outer cap <NUM> onto female luer connectors, the inner cap <NUM> retreats towards the chamber <NUM> at the closed end <NUM> of the outer cap <NUM>, thus, providing space for female luer connectors to be inserted and screwed onto the threads <NUM> of the outer cap <NUM>. Upon mounting the inner cap <NUM> of device <NUM> onto a male luer connector, the one or more thread-tabs <NUM> on the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> engage with the threads on the male luer connector. Hence the disclosed cap can be mounted onto both male and female luers.

The device <NUM> can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the chamber of the outer cap. The disinfectant or antimicrobial agent can be directly included in the chamber or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of outer cap. In one or more embodiments, the disinfectant or antimicrobial agent 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.

The peelable seal on the end face <NUM> to prevent the disinfectant or the antimicrobial agent from exiting the chamber <NUM>.

In one or more embodiments, the outer cap exterior wall surface <NUM> includes a plurality of grip members.

Referring to <FIG>, a device <NUM> for connection to a medical connector according to an exemplary embodiment of the present invention generally comprises an outer cap <NUM>, an inner cap <NUM>, and a peelable seal. As discussed further herein, device <NUM> can fit a broad range of luer fitting, including closed female luer, open female luer, and male luer fittings, while is capable of disinfecting the medical implement such as access ports including needleless connectors, male connectors on intravenous lines, stopcocks, and hemodialysis connectors. The inner cap <NUM> is in a slidable arrangement with the outer cap <NUM>.

The outer cap <NUM> comprises an integral body <NUM>, a closed end <NUM>, an annular wall <NUM> having a length LO3 extending from the closed end <NUM> to an open end <NUM> and defining a chamber <NUM> containing an absorbent material and disinfectant or antimicrobial agent. The open end defines an end face <NUM>.

The annular wall of the outer cap comprises an outer cap exterior wall surface <NUM> and an outer cap interior wall surface <NUM>. The outer cap interior wall surface includes one or more grooves <NUM> and one or more threads <NUM> adapted to engage with a female luer connector, wherein at least a portion of said one or more threads <NUM> on the outer cap interior wall surface <NUM> comprise one or more gaps <NUM> that does not engage a mating feature of the inner cap <NUM>.

The inner cap <NUM> slidably engages with the outer cap <NUM>. The inner cap <NUM> comprises an integral body <NUM> having an annular wall <NUM> having an exterior wall surface <NUM> and an interior wall surface <NUM> with a first end <NUM> of the inner cap <NUM> facing the closed end <NUM> of the outer cap <NUM> and a second end <NUM> of the inner cap <NUM> facing the open end <NUM> of the outer cap <NUM>. The exterior wall surface <NUM> of the first end <NUM> of the inner cap <NUM> includes two shaft-like wings <NUM> to fit into the one or more grooves <NUM> of the outer cap interior wall surface <NUM> and facilitate the slide motion without allowing significant relative rotation between the inner cap <NUM> with respect to the outer cap <NUM>. The exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes one or more thread-tabs <NUM> adapted to engage a male luer connector. The inner cap <NUM> is in a slidable arrangement with the outer cap <NUM>.

The function of the one or more gaps <NUM> is to accommodate the one or more thread-tabs <NUM> adapted to engage a male luer connector on the inner cap <NUM> when sliding motion occurs. The position of the one or more gaps <NUM>, as well as the position of the threads on the inner cap, is to be adjacent to the sliding grooves <NUM> in order to minimize the gap size and utilize the width of the sliding groove <NUM> as a part of an accommodation space. The thread-tabs <NUM> of the inner cap <NUM> and the threads <NUM> of the outer cap <NUM> are no longer restrained by interference therefore enabling a sliding fit. The dimension of threads can be optimized to maximize the engagement between the thread-tabs <NUM> of the inner cap <NUM> and the outer cap <NUM> to the correspondent connectors which improves the mechanical performance of the device when used with connectors in terms of resistance to overriding torque and resistance to axial separation force, hence allowing the device to be more securely attached to luer connectors.

In one or more embodiments, the open end <NUM> of the outer cap <NUM> is situated on a same horizontal plane as the second end <NUM> of the inner cap <NUM> in an initial state.

When a male luer connector is engaged to the one or more threads of the exterior wall surface of the second end of the inner cap and rotated in a clockwise direction, the inner cap <NUM> partially protrude out from the open end <NUM> of the outer cap <NUM>.

When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a counter-clockwise direction, the inner cap <NUM> retracts into the chamber <NUM> of the outer cap <NUM>.

When a female luer connector is engaged to the device <NUM>, the inner cap <NUM> slides against the outer cap <NUM> and retracts into the chamber <NUM> of the outer cap <NUM> to allow the female luer connector to engage the one or more threads <NUM> on the interior wall surface <NUM> of the outer cap <NUM>.

In one or more embodiments, the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes two thread-tabs <NUM> adapted to engage a male luer connector having collars with female threads.

In one or more embodiments, the female connector may be selected from the group consisting of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors.

In one or more embodiments, the male connector may be an intravenous tubing, stopcock end or male lock luer.

In one or more embodiments, the gaps <NUM> of the one or more threads <NUM> of the outer cap interior wall surface <NUM> are disposed adjacent to the grooves <NUM> of the outer cap interior wall surface <NUM> to allow sliding of the inner cap <NUM> against the outer cap <NUM>.

The gaps <NUM> of the one or more threads <NUM> of the outer cap interior wall surface <NUM> accommodate the one or more thread-tabs <NUM> on the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> when the inner cap <NUM> slides against the outer cap <NUM>.

In one or more embodiments, a snapping mechanism may be introduced at the rear end of inner cap <NUM> to lock in position with the outer cap <NUM> so that it can stay in place upon assembly. The mechanism has an interference such that the force resulting from screwing inner cap on male connectors can dislocate the inner cap, as well as the force resulting from pushing on the inner cap by female connector can dislocate the inner cap.

In one or more specific embodiments, the two shaft-like wings <NUM> on the exterior wall surface <NUM> of the first end <NUM> of the inner cap further comprise one or more pockets <NUM> having a snap-fit arrangement with one or more protrusions <NUM> disposed on the one or more grooves <NUM> of the outer cap interior wall surface <NUM> to fix the position of the inner cap <NUM> with the outer cap <NUM>.

When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a clockwise direction, the one or more pockets <NUM> on the two shaft-like wings <NUM> of the inner cap <NUM> disengage from the one or more protrusions <NUM> on the outer cap interior wall surface <NUM> to allow the inner cap <NUM> to partially protrude out from the open end <NUM> of the outer cap <NUM>.

When a female luer connector is engaged to the device, the inner cap <NUM> will be pushed and the one or more pockets <NUM> on the two shaft-like wings <NUM> of the inner cap <NUM> disengage from the one or more protrusions <NUM> on the outer cap interior wall surface <NUM> to allow the inner cap <NUM> to move toward the closed end <NUM> of the outer cap and into the chamber <NUM>.

In one or more embodiments, the two shaft-like wings <NUM> on the exterior wall surface <NUM> of the first end <NUM> of the inner cap <NUM> further comprise one or more protrusions <NUM> having a snap-fit arrangement with one or more corresponding one or more pockets <NUM> disposed on the one or more grooves <NUM> of the outer cap interior wall surface <NUM> to fix the position of the inner cap <NUM> with the outer cap <NUM>.

Inner cap <NUM> can slide back and forth with respect to outer cap <NUM>. In one or more embodiments, the open end <NUM> of the outer cap <NUM> is situated on the same horizontal plane P as the second end <NUM> of the inner cap <NUM> in an initial state. When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM>, the inner cap <NUM> slides against the outer cap <NUM> to partially protrude out from the open end <NUM> of the outer cap <NUM>. When a female luer connector is engaged to the device <NUM>, the inner cap <NUM> slides against the outer cap <NUM> and retracts into the chamber <NUM> of the outer cap <NUM> to allow the female luer connector to engage the one or more threads <NUM> on the interior wall surface <NUM> of the outer cap <NUM>. The thread-tabs <NUM> of the inner cap <NUM> and the threads <NUM> of the outer cap <NUM> are intrinsically non-interfering with each other, and are no longer restrained by interference that enables sliding fit.

Disinfecting caps currently on the market are capable of only disinfecting one of the three types of luer fitting, namely female luer of needle-free connectors, female luer of stopcocks, and male luer connectors on intravenous injection sites. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, device <NUM> is self-adaptive to different types of luer connectors due to the sliding mechanism between the inner cap <NUM> that engages with male luer connectors and the outer cap <NUM> that engages with female luer connectors thereby allowing the user to clean different types of connectors with a single device. Thus, to avoid having to use different types of disinfecting caps to clean different types of connectors, device <NUM> and other embodiments of the present disclosure provides a single device to be used for cleaning different types of connectors. Upon mounting the outer cap <NUM> onto female luer connectors, the inner cap <NUM> retreats towards the chamber <NUM> at the closed end <NUM> of the outer cap <NUM>, thus, providing space for female luer connectors to be inserted and screwed onto the threads <NUM> of the outer cap. Upon mounting the inner cap of device <NUM> onto a male luer connector, the one or more thread-tabs <NUM> on the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> engage with the threads on the male luer connector. Hence the disclosed cap can be mounted onto both male and female luers. The threads of the inner cap and the threads of the outer cap are intrinsically non-interfering with each other and the dimension of the threads of the inner cap and the threads of the outer cap are independent with each other while meeting the luer standard.

The device <NUM> can achieve disinfection when used on luer connectors by integrating an absorbent material having a disinfectant or antimicrobial agent in the chamber <NUM> of the outer cap <NUM>. The disinfectant or antimicrobial agent can be directly included in the chamber or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of outer cap. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting 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. The device of claim <NUM>, wherein the disinfectant or antimicrobial agent is selected from the group consisting 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 embodiments, the disinfectant or antimicrobial agent may be a fluid or a gel. In one or more embodiments, the absorbent material compresses toward the closed end of the chamber upon connection to the female luer connector or the male luer connector. The compression of the absorbent material <NUM> disinfects the female luer connector or the male luer connector.

Referring to <FIG>, a device <NUM> for connection to a medical connector according to the present disclosure generally comprises an outer cap <NUM>, an inner cap <NUM>, and a peelable seal.

The outer cap <NUM> comprises an integral body <NUM>, a closed end <NUM>, an outer cap annular wall <NUM> having a length LO4 extending from the closed end <NUM> to an open end <NUM> and defining a chamber <NUM> containing an absorbent material <NUM> and disinfectant or antimicrobial agent. The open end <NUM> of the outer cap <NUM> defines an end face <NUM>.

The outer cap annular wall <NUM> comprises an outer cap exterior wall surface <NUM> and an outer cap interior wall surface <NUM>. The outer cap interior wall surface <NUM> includes one or more pockets <NUM>.

The inner cap <NUM> comprises an integral body <NUM> having an annular wall <NUM> having an exterior wall surface <NUM> and an interior wall surface <NUM> with a first end <NUM> of the inner cap facing the closed end of the outer cap, a second end <NUM> of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes a flexure hinge <NUM> adapted to engage the one or more pockets <NUM> of the outer cap interior wall surface <NUM> to fix the position of the inner cap <NUM> with the outer cap <NUM>. The exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> includes one or more thread-tabs <NUM> adapted to engage a male luer connector.

In one or more embodiments, the inner cap <NUM> is connected to the interior surface <NUM> of the outer cap by an elastic element designed as a flexure hinge <NUM>, as shown in <FIG>. The flexure hinge is a relatively long cantilever hinge connected to the inner cap. The hinge assembly further includes two flexures that are provided to secure the inner cap <NUM> with the outer cap <NUM>. Each flexure includes a first portion that is connected to the inner cap, a second portion that is connected to one or more pockets <NUM> formed in the interior surface <NUM> of the annular wall of the outer cap <NUM>. As used herein, a flexure hinge <NUM> is a hinge that allows motion by bending a load element. In one embodiment, the flexure hinge <NUM> is fabricated from any suitable plastic material that enables the movement of the inner cap <NUM> with respect to the outer cap <NUM>. In one or more embodiments, the flexure hinge 470is fabricated from material that can be repeatedly flexed without degradation or failure.

In one or more embodiments, flexure hinge <NUM> may be made from a plastic material preferably such as injection molded polypropylene or ultra-high molecular weight polyethylene (UHMW-PE) whose material properties permit a short flexure length while at the same time permitting a high number of flexing motion cycles.

When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and the connector is rotated in a clockwise direction when viewed from the open end of the cap, the flexure hinge <NUM> on the inner cap disengages from the pocket <NUM> on the outer cap interior wall surface <NUM> to allow the inner cap <NUM> to partially protrude out from the open end <NUM> of the outer cap <NUM>. When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a counter-clockwise direction, the inner cap <NUM> retracts into the chamber <NUM> of the outer cap <NUM>.

When a female luer connector is engaged to the device, the inner cap <NUM> will be pushed and the interlocking between the flexure hinge <NUM> on the inner cap and the pocket <NUM> on the outer cap will be dislodged to allow the inner cap <NUM> to move toward the closed end <NUM> of the outer cap and into the chamber <NUM>.

The inner cap <NUM> and/or the outer cap 402is made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.

In one or more embodiments, the female luer connector may be selected from a group consisting of needle-free connectors, stopcocks, and hemodialysis connectors.

Referring to <FIG>, a device <NUM> for connection to a medical connector according to the present disclosure generally comprises an outer cap, an inner cap, and a peelable seal.

The outer cap <NUM> comprises an integral body <NUM>, a closed end <NUM>, an annular wall <NUM> having a length LO5 extending from the closed end <NUM> to an open end <NUM> and defining a chamber <NUM> containing an absorbent material <NUM> and disinfectant or antimicrobial agent. The open end of the body defines an end face <NUM>. In one or more embodiments, the annular wall comprises a flared curvature at the open end of the body defining an end face <NUM>. In one or more embodiments, the integral body <NUM> of the outer cap has a geometry that is modified to reduce the outer diameter and height of the outer cap. The reduction in size and weight reduces the risk of interfering with patients' activity and irritation on patients' skin. Luer threads on the inner cap are designed to not interfere with the threads on the outer cap without additional cuts into the outer cap threads, thus facilitate the molding process.

The outer cap annular wall <NUM> comprises an outer cap exterior wall surface <NUM> and an outer cap interior wall surface <NUM>, the interior wall surface <NUM> having one or more protrusions <NUM>. The inner cap <NUM> comprises an integral body <NUM> having an annular wall <NUM> having an exterior wall surface <NUM> and an interior wall surface <NUM> with a first end <NUM> of the inner cap facing the closed end of the outer cap, a second end <NUM> of the inner cap facing the open end of the outer cap. The exterior wall surface of the first end of the inner cap includes a dimple <NUM> adapted to engage the one or more protrusions of the interior wall surface of the outer cap to fix the position of the inner cap with the outer cap. The exterior wall surface of the second end of the inner cap includes one or more thread-tabs <NUM> adapted to engage a male luer connector. The peelable seal <NUM> on the end face <NUM> to prevent the disinfectant or the antimicrobial agent from exiting the chamber <NUM>.

When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface <NUM> of the second end <NUM> of the inner cap <NUM> and rotated in a clockwise direction, the inner cap <NUM> partially protrude out from the open end <NUM> of the outer cap <NUM>.

When a male luer connector is engaged to the one or more thread-tabs <NUM> of the exterior wall surface of the second end of the inner cap and rotated in a counter-clockwise direction, the inner cap <NUM> retracts into the chamber <NUM> of the outer cap <NUM>.

When a female luer connector is engaged to the device, the inner cap <NUM> slips and retracts into the chamber <NUM> of the outer cap <NUM>.

In one or more embodiments, the outer cap exterior wall surface <NUM> can include indicia, graphics, symbols, diagrams, words or other instructions.

In one or more embodiments, curvature is added to the outer cap exterior wall surface <NUM>. In one or more embodiments, a plurality of gripping members <NUM> is added to the outer cap exterior wall surface <NUM> to enhance the grip. In one or more embodiments, the plurality of gripping members <NUM> may be in the form of ribs.

The inner cap <NUM> and/or the outer cap 502is made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.

As shown in <FIG> and <FIG>, in one or more embodiments, the female connector <NUM> is selected from the group consisting of needle-free connectors, stopcocks, and hemodialysis connectors.

As shown in <FIG> and <FIG>, in one or more embodiments, the male connector <NUM> may be an intravenous tubing end, stopcock or a male lock luer.

Referring to <FIG>, in one or more embodiments, the cap of the device of the present disclosure forms a fluid-tight seal with a female luer connector <NUM>, male luer connector <NUM> or hemodialysis connector <NUM>. Referring to <FIG>, in one or more embodiments, the cap of the device of the present disclosure is tapered to form a fluid-tight seal with a male luer connector <NUM>. In specific embodiments, the cap is compliant with ISO standards (e.g., ISO <NUM>-<NUM>:<NUM> and ISO <NUM>-<NUM>:<NUM>) for forming a seal with a male luer.

In one or more embodiments, the cap of the device of the present disclosure has threads that have a size and pitch to engage a threadable segment of a female connector, such as for example, a female luer connector. Such connectors are generally and commonly used as catheter and other fluid-tight protective connectors in medical applications. In some embodiments, the cap provides a protective cover for a female luer connector when engaged with the connector when threads from the female luer connector engage and form a releasable connection with threads of the cap.

In some embodiments, the connector comprises a needleless injection site, which may sometimes be referred to as a needleless injection port, hub, valve, or device, or as a needleless access site, port, hub, valve, or device, and which can include such brands as, for example, Clave® (available from ICU Medical, Inc. ), SmartSite® (available from Cardinal Health, Inc. ), and Q-Syte™ (available from Becton, Dickinson and Company). In some embodiments, the cap can be connected with any of a variety of different needleless injection sites, such as those previously listed. 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 replaces the standard swabbing protocol for cleaning connectors. In one or more embodiments, threads of the cap are sized and pitched to engage threads of a male luer-lock connector. For example, connector can comprise the end of an IV tubing set that is disconnected from an IV catheter needleless injection site.

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 device (<NUM>, <NUM>)
for connection to a medical connector, the device comprising:
an outer cap (<NUM>, <NUM>) comprising an integral body (<NUM>, <NUM>), a closed end (<NUM>, <NUM>), an outer cap annular wall (<NUM>, <NUM>) having a length LO3 extending from the closed end to an open end (<NUM>, <NUM>) and defining a chamber (<NUM>, <NUM>) containing an absorbent material (<NUM>, <NUM>) and disinfectant or antimicrobial agent, the open end defining an end face : (<NUM>, <NUM>) ; a peelable seal (<NUM>, <NUM>) on the end face to prevent the disinfectant or the antimicrobial agent from exiting the chamber;
the outer cap annular wall having an outer cap exterior wall surface (<NUM>, <NUM>) and an outer cap interior wall surface (<NUM>, <NUM>),
the outer cap interior wall surface having one or more grooves (<NUM>, <NUM>) and one or more threads (<NUM>, <NUM>)
adapted to engage with a female luer connector, wherein at least a portion of said one or more threads on the outer cap interior wall surface comprise one or more gaps;
an inner cap (<NUM>, <NUM>) slidably engaged with the outer cap comprising an integral body (<NUM>, <NUM>) having an annular wall (<NUM>, <NUM>) having an exterior wall surface (<NUM>, <NUM>) and an interior wall surface (<NUM>, <NUM>) with a first end (<NUM>, <NUM>) of the inner cap facing the closed end (<NUM>, <NUM>) of the outer cap, a second end (<NUM>, <NUM>) of the inner cap facing the open end (<NUM>, <NUM>) of the outer cap, characterized in that the exterior wall surface (<NUM>, <NUM>) of the first end of the inner cap (<NUM>, <NUM>) includes two shaft-like wings (<NUM>, <NUM>) to fit into the one or more grooves (<NUM>, <NUM>) of the outer cap interior wall surface (<NUM>, <NUM>) and facilitate a slide motion without allowing significant relative rotation between the inner cap with respect to the outer cap, the exterior wall surface (<NUM>, <NUM>) of the second end of the inner cap (<NUM>, <NUM>) having one or more thread-tabs (<NUM>, <NUM>) adapted to engage a male luer connector, wherein the inner cap is in a slidable arrangement with the outer cap.