Universal Cap For Male And Female Connectors

Abstract

A device for connection to a medical connector, the device includes a cap, an elastic sealing ring, a locking lid and a peelable seal. The cap configured to define a chamber to contain an absorbent material and disinfectant or antimicrobial agent. The cap may include one or more threads adapted to engage with a female luer connector. The cap is adapted to engage a male luer connector in a press-fit connection. The peelable seal prevents the disinfectant or the antimicrobial agent from exiting the chamber. Also described are methods of disinfecting a medical connector, and an assembly comprising a device for disinfecting a medical connector.

Claims

1. A device for connection to a medical connector, the device comprising: a cap comprising an integral body, a closed end, an annular wall having a length L.sub.C 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 having a peripheral ledge extending radially inward from the open end defining an end face and an engagement surface; the annular wall having an exterior wall surface and an interior wall surface; an elastic sealing ring having a dilatable opening therethrough sized and adapted to receive a male luer connector, a female luer connector and a hemodialysis connector; a locking lid engaged with the engagement surface and securing the elastic sealing ring to the open end, the locking lid having an end surface; and a peelable seal on the end face of the locking lid to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

2. The device of claim 1, wherein the female luer connector is selected from the group consisting essentially of needle-free connectors, catheter luer connectors, stopcocks, and hemodialysis connectors.

3. The device of claim 1, wherein the dilatable opening sized to frictionally engage a male luer connector.

4. The device of claim 1, wherein the male connector is an intravenous tubing end, stopcock or male lock luer.

5. The device of claim 1, wherein the elastic sealing ring is in contact with the peripheral ledge.

6. The device of claim 1, wherein the dilatable opening has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm.

7. The device of claim 1, further comprising internal threads adjacent the closed end that partially extend along a length of the interior wall surface.

8. The device of claim 1, wherein the peripheral ledge is sized and adapted to receive an elastic sealing ring.

9. The device of claim 1, wherein the cap comprises a polypropylene or polyethylene material.

10. The device of claim 1, wherein the elastic sealing ring comprises an elastomeric material.

11. The device of claim 10, wherein the elastomeric material comprises a thermoplastic elastomer.

12-15. (canceled)

16. The device of claim 1, wherein the absorbent material has slits.

17. The device of claim 1, wherein a compression of the absorbent material toward the closed end of the chamber occurs upon connection to the female luer connector or the male luer connector.

18. The device of claim 17, wherein compression of the absorbent material disinfects the female luer connector or the male luer connector.

19. The device of claim 6, wherein the absorbent material is under radial compression by the internal threads to retain the absorbent material in the chamber.

20. The device of claim 1, wherein 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.

21. The device of claim 20, wherein the disinfectant or antimicrobial agent comprises at least one of chlorhexidine gluconate and chlorhexidine diacetate.

22. The device of claim 1, wherein the disinfectant or antimicrobial agent is a fluid or a gel.

23. The device of claim 1, wherein the peelable seal comprises an aluminum or multi-layer polymer film peel back top.

24. The device of claim 1, wherein the peelable seal is heat-sealed or induction sealed to the engagement surface.

25-26. (canceled)

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 shows a perspective view of an embodiment of a device of the present disclosure;

[0028] FIG. 2 shows a perspective elevation view of a device according to an embodiment of the present disclosure;

[0029] FIG. 3 shows a partial sectional view of the components of a device according to an embodiment of the present disclosure taken along line 3-3 of FIG. 1;

[0030] FIG. 4 shows a bottom view of a component of the device of FIG. 1;

[0031] FIG. 5 shows a perspective view of an exemplary elastic sealing ring of the device of FIG. 1;

[0032] FIG. 6 shows a perspective view of an exemplary peelable seal of the device of FIG. 1;

[0033] FIG. 7 shows a perspective view of an exemplary locking ring of the device of FIG. 1;

[0034] FIG. 8 shows a bottom perspective view of an exemplary locking ring of the device of FIG. 1;

[0035] FIG. 9 shows a top view of an exemplary absorbent material of the device of FIG. 1;

[0036] FIG. 10 shows a perspective view of an exemplary absorbent material of the device of FIG. 1;

[0037] FIG. 11 shows a perspective view of a female luer connector with septum according to the prior art;

[0038] FIG. 12 shows a perspective view a female luer connector with stopcock according to the prior art;

[0039] FIG. 13 shows a perspective view of a male luer connector according to the prior art;

[0040] FIG. 14 shows a perspective view of a hemodialysis connector according to the prior art.

DETAILED DESCRIPTION

[0041] 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.

[0042] Embodiments of the disclosure pertain to a sterile, 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 a cap, an elastic sealing ring, absorbent material, a disinfectant or the antimicrobial agent and a peelable seal. 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.

[0043] With respect to terms used in this disclosure, the following definitions are provided.

[0044] As used herein, the use of “a,” “an,” and “the” includes the singular and plural.

[0045] 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.

[0046] 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.

[0047] The assembled device is shown in FIGS. 1-3, with the components shown separately in FIGS. 4-10. FIGS. 11-14 show various connectors according to the prior art. Referring to FIGS. 1-3, a device 100 for connection to a medical connector according to an exemplary embodiment of the present disclosure generally comprises a cap 102, absorbent material 114, a disinfectant or an antimicrobial agent, an elastic sealing ring 126, a locking lid 130, and a peelable seal 150. Referring to FIG. 4, the cap 102 comprises an integral body 104, a closed end 106, an annular wall 108 having a length L.sub.C extending from the closed end 106 to an open end 110 that defines a chamber 112 containing an absorbent material 114 and disinfectant or antimicrobial agent. The open end 110 defines an end face 118 and comprises a peripheral ledge 116 extending radially inward from the annular wall 108. The open end 110 also defines an engagement surface 120.

[0048] Referring to FIGS. 3 and 4, the annular wall 108 of the cap 102 comprises an exterior wall surface 122 and an interior wall surface 124. The interior wall surface 124 defines an opening 138 adjacent the open end 110.

[0049] Referring to FIG. 3, in one or more embodiments, the elastic sealing ring 126 is in contact with the peripheral ledge 116.

[0050] Referring to FIG. 5, the elastic sealing ring 126 comprises a dilatable opening 128 therethrough sized and adapted to receive a male luer connector, a female luer connector, and a hemodialysis connector. The dilatable opening 128 can be sized to frictionally engage a male luer connector. In one or more embodiments, the dilatable opening 128 has a diameter that is dilatable from an initial diameter in a range from about 7-9 mm to a dilated diameter in a range from about 9-12 mm. In one or more embodiments, the male luer connector frictionally engages the dilatable opening 128 via a press-fit connection upon insertion into the chamber 112 through the dilatable opening 128 of the elastic sealing ring 126. In one or more embodiments, the elastic sealing ring 126 is the shape of an O-ring.

[0051] Thus, use of the device 100 requires only one single mounting movement by a user. Use of the device 100 does not activate the fluid path of a female luer connector having a septum or a hemodialysis connector having a sheath.

[0052] Referring to FIG. 3, in one or more embodiments, the elastic sealing ring 126 is in contact with the peripheral ledge 116. Referring to FIGS. 3 and 4, in one or more embodiments, the opening 138 adjacent the open end 110 of the interior wall surface 124 is sized and adapted to receive an elastic sealing ring 126 in a press-fit connection.

[0053] In one or more embodiments, the interior wall surface 124 comprises internal threads adjacent to the closed end 106. The internal threads are adapted and sized to engage a female luer connector. In one or more embodiments, the internal threads adjacent the closed end 106 of the cap 102 partially extend along a length of the interior wall surface 124 of the cap 102.

[0054] The absorbent material 114 and the disinfectant or the antimicrobial agent contacts the male luer connector 200, the female luer connector 300, and the hemodialysis connector 400 after insertion of the connector through the dilatable opening 128 of the elastic sealing ring 126.

[0055] Referring to FIG. 1 and to FIGS. 7-8, the locking lid 130 engages with the engagement surface 120 of the cap 102 and secures the elastic sealing ring 126 to the open end 110 of the cap 102. The locking lid 130 has an end surface 132, where the peelable seal 150 may be secured.

[0056] Referring to FIGS. 1-3 and FIG. 6, in one or more embodiments, the peelable seal 150 is disposed on the end surface 132 of the locking lid 130 to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112. With the absorbent material 114 properly inserted into the chamber 112 of the cap 102, the peelable seal 150 may be secured to the end surface 132 of the locking lid 130 to seal the device 100. The peelable seal 150 minimizes entry of potential particulate hazard and also provides a substantially impermeable enclosure for the device 100, provides a leak prevention and protection enclosure, protects the contents of absorbent material 114 contained within the chamber 112, and/or maintains a sealed, sterilized environment. The peelable seal 150 provides a sufficient seal at a range of temperatures, pressures, and humidity levels.

[0057] The interior wall surface 124 comprises internal threads adjacent to the closed end 106. The internal threads are adapted and sized to engage a female luer connector. The absorbent material 114 and the disinfectant or the antimicrobial agent contacts the male luer connector, the female luer connector, and the hemodialysis connector after insertion of the connector into the open end 110 of the cap 102.

[0058] Referring to FIGS. 1 and 2, in one or more embodiments, the exterior wall surface 122 of the cap 102 comprises a plurality of grip members 136.

[0059] Referring to FIG. 3, the cap 102 comprises an annular cap wall 108 having a cap wall length L.sub.C extending from a cap closed end 106 to a cap open end 110. The cap 102 comprises an interior wall surface 124 and an exterior wall surface 122.

[0060] 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 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.

[0061] In one or more embodiments, the male connector may be an intravenous tubing end, a stopcock or male lock luer.

[0062] In one or more embodiments, the male luer connector rests on the peripheral ledge upon being fully inserted in into the chamber 112.

[0063] In one or more embodiments, the internal threads may be disposed adjacent the closed end 106 of the cap 102 partially extend along a length of the interior wall surface 124 of the cap 102.

[0064] In one or more embodiments, the male luer connector frictionally engages the interior wall surface 124 via a press-fit connection upon insertion into the chamber 112.

[0065] Referring to FIG. 4, in one or more embodiments, the opening 138 adjacent the open end 110 of the interior wall surface 124 of the cap 102 is sized and adapted to receive a male luer connector in a press-fit connection.

[0066] Referring to FIG. 5, the elastic sealing ring 126 comprises an elastomeric material.

[0067] In one or more embodiments, the elastomeric material of the elastic sealing ring 126 comprises a thermoplastic elastomer.

[0068] Referring to FIG. 1 and FIGS. 7-8, in one or more embodiments, the locking lid 130 can engage with the engagement surface 120 to secure the elastic sealing ring 126 to the open end 110. The locking lid 130 comprises an end surface 132. The locking lid 130 prevents the elastic sealing ring 126 from moving during insertion of a male luer connector or female luer connector into the dilateable opening 128 of the elastic sealing ring 126. The locking lid 130 can be attached to cap 102 using various methods including, but not limited to, mechanical fasteners, snap-fittings, and threaded connection.

[0069] Referring to FIG. 1 and FIGS. 7 and 8, in one or more embodiments, the locking lid 130 comprises a peripheral sidewall 140 extending substantially perpendicularly from a base 142. The locking lid 130 is adapted to be snap fit over the open end 110 of the cap 102. Referring to FIG. 8, in one or more embodiments, the locking lid 130 may be connected to the cap 102 with a rim 144 disposed between the locking lid 130 and the cap 102.

[0070] In one or more alternate embodiment, an interior surface 146 of the peripheral sidewall 140 of the locking lid 130 or the exterior annular wall surface 122 of the cap 102 at the open end 110 includes at least one protrusion 148 which corresponds to at least one mating protrusion 152 disposed on an interior surface 146 of the peripheral sidewall 140 of the locking lid 130 or the exterior annular wall surface 122 of the cap 102. Protrusion 148 and mating protrusion 152 mate together such that when locking lid 130 is connected by protrusion 148 to mating protrusion 152, a leak-resistant connection is formed between the locking lid 130 and the cap 102. In one or more embodiments, protrusion 148 and mating protrusion 152 are threads.

[0071] In one or more embodiments, the locking lid 130 is a snap fit connection. In one or more embodiments, the snap fit connection comprises a protruding edge and a snap-in area. The protruding edge may be disposed on an interior surface 146 of the peripheral sidewall 140 of the locking lid 130 or the exterior annular wall surface 122 of the cap 102 at the open end 110, and the corresponding snap-in area is disposed on the opposite surface as the protruding edge to allow the protruding edge and snap-in area to interlock.

[0072] The cap 102 and the locking lid 130 are made from any of a number of types of plastic materials such as polycarbonate, polypropylene, polyethylene, polyethylene terephthalate, polylactide, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices. In one or more embodiments, the cap 102 comprises a polypropylene or polyethylene material. In one or more embodiments, the exterior wall surface 122 includes a plurality of grip members 136.

[0073] Referring to FIG. 3 and FIGS. 9 and 10, in one or more embodiments, the absorbent material 114 is under radial compression by the internal threads to retain the absorbent material 114 in the chamber 112. In one or more embodiments, the absorbent material 114 is a nonwoven material, foam, or a sponge. In a specific embodiment, the foam is a polyurethane foam. In a specific embodiment the absorbent material 114 is in the form of a foam plug. In one or more embodiments, the absorbent material 114 includes one or more slits 154.

[0074] The device 100 can achieve disinfection when used on luer connectors by integrating disinfectant or antimicrobial agent in the chamber 112 of the cap 102. The disinfectant or antimicrobial agent can be directly included in the chamber 112 or disinfectant or antimicrobial agent can be absorbed into sponges or foam material that fills the chamber of cap 102. 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. 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.

[0075] Compression of the absorbent material 114 toward the closed end 106 of the chamber 112 upon 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.

[0076] Referring to FIG. 1, the peelable seal 150 on the end face 132 to prevent the disinfectant or the antimicrobial agent from exiting the chamber 112. In one or embodiments, the peelable seal 150 may be placed on the end face 132 to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

[0077] In one or more embodiments, the peelable seal 150 comprises an aluminum or multi-layer polymer film peel back top. In a specific embodiment, the peelable seal 150 is heat-sealed or induction sealed to the end face of the locking lid or to the cap open end. In one or more embodiments, the peelable seal 150 comprises a moisture barrier.

[0078] The device 100 of the present disclosure is capable of continuous disinfection of a connector for 7 days. The device 100 of the present disclosure minimizes ingress of microbial agents.

[0079] In one or more embodiments, the cap exterior wall surface 122 includes a plurality of grip members 136.

[0080] 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 100 with cap 102 engages with male luer connectors and also with female luer connectors thereby allowing the user to clean different types of connectors with a single device. Upon mounting the cap 102 onto female luer connectors, the female luer connectors is inserted into the chamber 112 and screwed onto the threads of the cap. Upon mounting the cap onto a male luer connector, the male luer connector frictionally engage the interior wall 124 upon insertion into the chamber 112. Hence, the device of the present disclosure can be mounted onto both male and female luer connectors, thus fulfilling a current need in the art.

[0081] 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 device of one or more embodiments to a medical connector, wherein connecting includes frictionally engaging the interior wall surface upon insertion into the chamber such that the medical connector contacts the absorbent material and the disinfectant or antimicrobial agent.

[0082] In one or more embodiments, an assembly comprises the device of one or more embodiments connected to a medical connector. In one or more embodiments, the medical connector is selected from a male luer connector, a female luer connector, and needleless connector.

[0083] Referring to FIGS. 11 to 14, in one or more embodiments, the cap of the device of the present disclosure may form a fluid-tight seal with a male luer connector 200, female luer connector 300, or hemodialysis connector 400. Referring to FIGS. 11 to 14, 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. In specific embodiments, the cap is compliant with ISO standards (e.g., ISO 594-1:1986 and ISO 594-2:1998) for forming a seal with a male luer connector.

[0084] 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.

[0085] 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.

[0086] 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.

[0087] 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.

[0088] 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.