Patent ID: 12257414

DETAILED DESCRIPTION

Embodiments of the disclosure pertain to a sterile, universal cap for connection to and disinfection of a medical connector, including male connectors and female connectors. The male connectors and female connectors can be male luer connectors and female luer connectors. Embodiments of the cap comprise a housing having a cavity and a protrusion disposed within the cavity. The cavity defines a closed end, an open bottom and an inner sidewall, the closed end having an external top wall and an internal distal wall. The inner sidewall of the housing having a length LCextending from the distal wall to the open bottom and defining a chamber. In one or more embodiments, the open bottom includes a peripheral ledge or rim extending radially outward from the open bottom defining an end face and an engagement surface where a peelable seal may be secured. The protrusion has an interior wall surface and an exterior wall surface, the interior wall surface having one or more threads adapted to engage a female luer connector, and the exterior wall surface having a taper from the distal wall, the taper extending in a proximal direction sized and adapted to engage a male luer connector in a press-fit connection sufficient to interlock with a mating feature of said male needleless connector. The cap may further comprise absorbent material, the absorbent material disposed within the chamber. The absorbent material containing a disinfectant or the antimicrobial agent within. The cap provides a mechanical barrier for connectors and retains the antimicrobial agent for disinfection. The cap 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 releas ably attaches the Luer connector to the hub of a VAD, and a proximal end channel that releasably attaches the Luer connector to the barrel of a syringe.

As would be readily appreciated by skilled artisans in the relevant art, while descriptive terms such as “lock”, “tip”, “hub”, “thread”, “sponge”, “prong”, “protrusion”, “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.

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 and spirit of the disclosure. Also, descriptions of well-known functions and constructions are omitted for clarity and conciseness.

Exemplary embodiments of the present disclosure provide caps that can reduce the number of device types and logistics currently needed in the hospital setting for connecting, capping, and/or disinfecting male and female threaded fluid luer connectors, by roughly half by including in a single cap or device features allowing it to be use with both male needleless connectors and female needleless connectors.

In one or more exemplary embodiments of present disclosure, a cap, connector cap or disinfecting cap includes tapered surfaces, integrated thread(s), and other features in any and all combinations allowing it to interface with both male needless connectors and female needless connectors, wherein the tapered surfaces secure the male needleless connector with a press-fit between the tapered surface of the cap and a corresponding tapered surface of the male needless connector, and the integrated threads engage corresponding threads of the female needless connector.

According to further exemplary implementations of the embodiments of the present disclosure, configuration of structural elements making up the cap include one or more cantilevered prongs disposed in cap's inner cavity, the cantilevered prongs comprising an inner thread to connect to female needless connectors and an outer tapered surface to connect to male needless connectors, to facilitate securing of the cap onto a female fitting or onto a male fitting, respectively.

According to still further exemplary implementations of the embodiments of the present disclosure, the cantilevered prong may be in the form of protrusion and may be of a split thread type in which the protrusion may elastically deform or bend in order to allow better interference fit compliance with the fittings.

According to still further exemplary implementations of the embodiments of the present disclosure, female threads are sized and have a thread pattern that will engage with a standard ISO594-2 type of male fitting and/or male threads that are sized and have a thread pattern that will engage with a standard ISO594-2 type of female fitting. An example of an ISO594-2 type of fitting is a Q-style fitting.

In one or more embodiments, the female needless connector may be selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors. In one or more embodiments, the needleless connector is selected from a Q-Syte connector, MaxPlus, MaxPlus Clear, MaxZero, UltraSite, Caresite, InVision-Plus, Safeline, OneLink, V-Link, ClearLink, NeutraClear, Clave, MicroClave, MicroClave Clear, Neutron, NanoClave, Kendall,Nexus, InVision, Vadsite, Bionector, etc.

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

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.

A first aspect of the present disclosure relates to a cap10including a housing20and a prong in the form of a protrusion30. As shown inFIGS.1-2, housing20includes a top wall22, an outer sidewall24. an essentially cylindrical inner sidewall26forming a first cavity28, and an open bottom23formed by the cylindrical sidewall26with an open bottom23to the first cavity28within the housing20for receiving a hub of a female needleless connector or a male needleless connector. In one or more embodiments, the open bottom23includes a peripheral ledge or rim29extending radially outward from the open bottom23defining an end face and an engagement surface where a peelable seal60may be secured.

In one embodiment, the protrusion30is integrally formed with the housing20and is positioned within the first cavity28. The protrusion30extends from the distal wall25at least partially the length Lc, the protrusion30including an inner surface31and an outer surface33, the inner surface31of protrusion30defining a second cavity40disposed within the protrusion30.

In one or more embodiments, the cap10of the present disclosure has inner thread36that has 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 one or more embodiments, cap10provides a protective cover for a female luer connector when engaged with the connector when threads from the female luer connector engage and form a releasable connection with inner threads36of cap10. The inner thread36can be included on the inner surface31of protrusion30, the inner thread36being sufficient to interlock with a mating feature of the female needleless connector. In one or more embodiments, the inner surface31of protrusion30comprises inner threads36running a partial or full length of the inner surface31from the distal wall25distal wall25. In one or more embodiments, the thread pattern is inclined. In one or more embodiments, the thread pattern is helical.

The outer surface33of the protrusion30is tapered, sized and adapted to engage a male luer connector in a press-fit connection sufficient to interlock with a mating feature of said male needleless connector. In one or more embodiments, the protrusion30can comprise one or more cantilevered prongs44separated by one or more respective gaps35. In one or more embodiments, at least one of the prongs44can be configured to elastically deform or bend to facilitate interference fit between the at least one prongs44and the mating feature of the male needleless connector or female needleless connector.

In one or more embodiments, protrusion30can extend essentially from the distal wall25in a proximal direction toward the open bottom23of the housing20. In one or more embodiments, the protrusion30can extend essentially parallel to the inner sidewall26of the housing20.

Referring toFIGS.2-5, according to exemplary embodiments of the present disclosure, the cap10comprises a housing20, the housing20including a top wall22, and an outer sidewall24, the outer sidewall24being essentially cylindrical. In one or more embodiments, the housing20further comprises peripheral ledge or rim29extending radially outward from the open bottom23defining an end face and an engagement surface where a peelable seal (not shown) may be secured. The exterior surface of the outer sidewall24further comprises a plurality of grip members90, aiding in rotation or handling of the housing20. The cap10is 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 cap10comprises a polypropylene or polyethylene material.

Referring toFIGS.6-8, according to exemplary embodiments of the present disclosure a cap10comprises a housing20which includes an inner sidewall26and a distal wall25defining a first cavity28, and an open bottom23into the first cavity28. From the distal wall25extends a protrusion30(which can be essentially cylindrical and coaxial with inner sidewall26) having an inner surface31defining a second cavity40, and a tapered outer surface33defining and outer portion of the first cavity28. The protrusion30comprises an inner thread36on its inner surface31for engaging a female connector and an outer surface33being tapered, sized and adapted to engage a male luer connector in a press-fit connection sufficient to interlock with a mating feature of said male needleless connector. The protrusion30is illustrated as comprising two prongs44spaced by cutouts or gaps35and extending essentially from the distal wall25in a proximal direction.

In an exemplary implementation, a peelable seal60can be provided to seal the open bottom23prior to use of cap10, for example, by attachment to a surface of a rim29of an open bottom23of housing20, as described for example in the above-referenced prior applications. Referring toFIG.1, in one or more embodiments, the peelable seal60is disposed on the engagement surface of open bottom23of housing20to prevent the disinfectant or the antimicrobial agent from exiting the first cavity28and second cavity40. As shown inFIG.9, the peelable seal60minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the cap10, providing a leak prevention and protection enclosure, protects the contents contained within the first cavity28and the second cavity40, and/or maintains a sealed, sterilized environment. The peelable seal60provides a sufficient seal at a range of temperatures, pressures, and humidity levels.

In one or more embodiments, the peelable seal60comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the peelable seal60is heat-sealed or induction sealed to the open bottom23of the cap. In one or more embodiments, the peelable seal60comprises a moisture barrier.

Referring toFIG.8-11, in one or more embodiments, an absorbent material50is disposed within the chamber defined by the first cavity28and second cavity40, the absorbent material being under radial compression by the inner thread36on the inner surface31of protrusion30to retain the absorbent material50in the first cavity28and second cavity40. As shown inFIG.9, the absorbent material50may be of a unitary cylindrical shape, having slits through which the prongs44of the protrusion30may pass through. As shown inFIG.10, in one or more embodiments, the absorbent material50comprises an inner cylindrical material51and an outer cylindrical material52. The inner cylindrical material51is disposed within the second cavity40, and the outer cylindrical material52being disposed within the first cavity28, the outer cylindrical material52being a ring having an aperture and an aperture diameter essentially equal to the diameter of the protrusion30, so that the outer cylindrical material52is disposed only within the first cavity28, being in contact with the inner sidewall26of the housing20and the outer surface33of the protrusion30. The absorbent material50, the inner cylindrical material51and outer cylindrical material52abut the distal wall25when placed within the first cavity28or second cavity40.

In one or more embodiments, the absorbent material50is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment the absorbent material50is in the form of a foam plug. In one or more embodiments, the absorbent material50includes one or more slits. With the absorbent material50properly inserted into the first cavity28and second cavity40, the peelable seal60may be secured to the engagement surface of open bottom23of housing20.

In yet another exemplary implementation, a disinfecting member or members, such as an absorbent material50, in the form of an IPA soaked sponge and/or sponge. In one or more embodiments, absorbent material50can also be formed together as a single cleaning member or separate cleaning member can be provided within first cavity28.

The cap10can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the absorbent material50, the inner cylindrical material51and/or outer cylindrical material52. The disinfectant or antimicrobial agent can be directly included in the first cavity28or second cavity40or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of cap10. Cap10is designed to be compatible in interacting with various disinfectants. In one or more embodiments, the disinfectant or antimicrobial agent may include variations of alcohol or chlorhexidine. In one or more embodiments, the disinfectant or antimicrobial agent is selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, butylated hydroxyanisole (BHA), butylated hydroxytoluene, t-butyl-hydroquinone, chloroxylenol, chlorohexidine, chlorhexidine diacetate, chlorohexidine gluconate, povidone iodine, alcohol, dichlorobenzyl alcohol, dehydroacetic acid, hexetidine, triclosan, hydrogen peroxide, colloidal silver, benzethonium chloride, benzalkonium chloride, octenidine, antibiotic, and mixtures thereof. In a specific embodiment, the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate. In one or more embodiments, the disinfectant or antimicrobial agent is a fluid or a gel.

Compression of the absorbent material50, the inner cylindrical material51and/or outer cylindrical material52toward the distal wall25of housing20upon connection to the female luer connector or the male luer connector allows the connector to contact the disinfectant or antimicrobial agent to disinfect the female luer connector or the male luer connector. Thus, compression of the absorbent material disinfects the female luer connector. The absorbent material50, the inner cylindrical material51and/or outer cylindrical material52and the disinfectant or the antimicrobial agent contacts the female or male luer connector after insertion of the female or male luer connector into the chamber of the cap.

In an exemplary implementation of embodiments of the present disclosure, protrusion30can be cantilevered, for example by having one or more cutouts or gaps35. In an exemplary implementation, at least a portion of the a cantilevered protrusion30may bend in order to allow better interference fit compliance with the fitting such as at least one of male connector or female connector.

In yet another exemplary implementation, protrusion30can extend essentially from the distal wall25toward the open bottom23of housing20.

In still further exemplary implementation, protrusion30can extend essentially parallel to inner sidewall26.

Referring toFIG.12, according to exemplary embodiments of the disclosure, cap10can receive a tip or hub72of a male needleless connector70, for example after a peelable seal (not shown) which seals first cavity28and second cavity40is removed or when the peelable seal (not shown) is pierced. The hub72is received within the second cavity40, while a collar76of the male needless connector70is received within first cavity28secured via a press-fit connection with a corresponding tapered collar of the male connector with an outer surface33of first cavity28. As the male needless connector70is advanced further into the first cavity28and second cavity40, the collar76cause the protrusion30to elastically deform or deflect inwardly.

Referring further toFIG.13, according to exemplary embodiments of the disclosure, cap10can receive a tip82of a female needleless connector80, for example after a peelable seal (not shown) which seals first cavity28and second cavity40is removed or when the peelable seal (not shown) is pierced. The tip82is threadedly secured to the inner thread36of the protrusion30. One or more threads36can be sufficient to interlock with a mating feature of a needleless connector

In an exemplary implementation ofFIGS.1and7-11, protrusion30is illustrated as comprising two prongs44spaced by cutouts or gap35and extending essentially from the distal wall25. However, also within the scope of the disclosure are caps comprising a unitary protrusion30without any cutouts or gaps35, and caps having a protrusion30comprising any number of identical and/or different (in any dimensional characteristics, such as length width, thickness, or shape) prongs, as long as protrusion30is configured to engage a female connector with respect to threads36on its inner surface, and engage a male connector with respect to its tapered outer surface.

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, cap10engages with male luer connectors and also with female luer connectors thereby allowing the user to clean different types of connectors with a single device, as shown inFIGS.12and13. Upon mounting the cap10onto female luer connectors, as shown inFIG.13, the female luer connectors is inserted into the second cavity40and screwed onto the threads36of the cap. Upon mounting the cap onto a male luer connector, as shown inFIG.12, the male luer connector frictionally engages the outer surface of the protrusion upon insertion into the first cavity28. Hence, the cap of the present disclosure can be mounted onto both male and female luer connectors, thus fulfilling a current need in the art.

Other aspects of the present disclosure are directed to methods of disinfecting medical connectors and assemblies. In one or more embodiments, a method of disinfecting a medical connector comprises connecting the cap of one or more embodiments to a medical connector, wherein connecting includes frictionally engaging a male medical connector onto the interior wall surface of the protrusion or upon insertion of a female medical connector into the chamber such that the female medical connector engages threads36and contacts the absorbent material50and the disinfectant or antimicrobial agent.

In one or more embodiments, an assembly comprises the cap10of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and needleless connector.

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

Although the disclosure herein has provided a description with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made to the method and apparatus of the present disclosure without departing from the spirit and scope of the disclosure. Thus, it is intended that the present disclosure include modifications and variations that are within the scope of the appended claims and their equivalents.