Universal disinfection device with rotatable sleeve

Abstract

A device for connection to a medical connector, the device includes a sleeve, an inner segment, and a removable seal. The inner segment including a chamber containing an absorbent material and disinfectant or antimicrobial agent and an inner blocking member. The sleeve including one or more threads adapted to engage with a female luer connector. The inner segment including one or more threads adapted to engage a male luer connector. The removable seal prevents the disinfectant or the antimicrobial agent from exiting the chamber. The inner blocking member prevents ingress of disinfectant or antimicrobial agent into the medical connector tip opening.

Description

P-28529.WO01 PATENT UNIVERSAL DISINFECTION DEVICE WITH ROTATABLE SLEEVE TECHNICAL FIELD

[0001] The present disclosure generally relates to a device for disinfecting and sterilizing access hubs and ports with, e.g., male and female luer fitting. More particularly, the present disclosure relates to a disinfecting and sterilizing device capable of accommodating multiple types of connectors, wherein leakage of a disinfectant agent from the device into the hub or access port is prevented when the device is attached to the access hub or port. BACKGROUND

[0002] 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.

[0003] 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.

[0004] 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 70% IPA alcohol pad to complete this disinfection task by doing what is known as "scrubbing the hub." However, compliance with this practice is typically very low. In addition to a lack ofP-28529.WO01 PATENT 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.

[0005] 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.

[0006] 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 2016 Infusion Nurses Standards (INS) guidelines.

[0007] Disinfecting caps generally integrate a disinfectant or antimicrobial agent within the cap, for example, by housing the disinfectant or antimicrobial agent within a chamber of the cap or absorbing the disinfectant or antimicrobial agent into a sponge or foam material disposed within the cap. These disinfecting caps can be attached to a hub or access port while not in use, providing a disinfected / sterilized hub or access port upon removal.

[0008] However, current disinfecting caps have drawbacks. Caps for male needleless connectors, female needleless connectors, intravenous (IV), and hemodialysis lines typically use different products and, therefore, can be limited to the types of connectors to which the cap can be attached. Most prior disinfecting caps were typically designed to fit one type of connector only and were specific to one particular size and / or shape of connector. Further, while disinfecting caps have been shown to provide superior disinfection compared to other methods, such as "scrubbing the hub", it has been found that isopropanol (IPA), which is typically used as an active ingredient in disinfecting caps, can leak through the hub or access port (also referred to as “IPA ingress”). As a result, there is a risk of injecting leaked IPA into a patient’s bloodstream, which can lead to medical complications.

[0009] 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 that prevents or reduces the potential for IPA ingress.P-28529.WO01 PATENT SUMMARY

[0010] One aspect of the present disclosure pertains to a disinfection device for connection to a medical connector, the disinfection device including a sleeve comprising an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer connector. An inner segment includes a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having either (a) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more threads adapted to engage a male luer connector or (b) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pins configured to engage with a male luer connector. A chamber is disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment. An absorbent material is disposed within the chamber, the absorbent material containing a disinfectant or antimicrobial agent. An inner blocking element is at least partially housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

[0011] In one or more embodiments, the absorbent material has a first end proximal the chamber wall, a second end proximal the inner segment open second end, and an opening disposed in the absorbent material second end and extending toward the absorbent material first end, the opening adapted to correspond to a tip of a medical connector.

[0012] In one or more embodiments, the absorbent material second end has a cross- section larger than the absorbent material first end, the absorbent material fist end is disposed within the chamber, and the absorbent material second end is disposed outside of the chamber abutting the inner segment open second end.P-28529.WO01 PATENT

[0013] In one or more embodiments, the inner blocking element comprises a protrusion extending from the chamber wall toward the inner segment open second end. The inner blocking element may also include an elongate member having a length extending through at least a portion of the opening between the absorbent material second end and absorbent material first end. In one or more embodiments, the elongate member has a first end proximal to or abutting the chamber wall and a second end proximal to the absorbent material second end, the elongate member second end adapted to engage and block a tip opening of the medical connector. In one or more embodiments, the elongate member is compressible along at least a portion of its length. In one or more embodiments, the elongate member comprises a plurality of compressible segments and non-compressible segments along its length.

[0014] In one or more embodiments, the open end of the inner segment is on approximately a same horizontal plane P as the open second end of the sleeve in an initial state.

[0015] In one or more embodiments, the open end of the inner segment is on approximately a same horizontal plane P as the absorbent material second end in an initial state.

[0016] In one or more embodiments, when a male luer connector is engaged to the one or more threads of the sleeve interior surface, the inner segment open second end is retracted within the sleeve with the one or more threads on of the sleeve interior surface exposed.

[0017] In one or more embodiments, when a female luer connector is engaged to the one or more threads of the inner segment exterior surface, the inner segment partially protrudes out from the open second end of the sleeve. The sleeve may be rotated in a counter clockwise direction to protrude the inner segment open second end out from the open second end of the sleeve, and the sleeve may be rotated in a clockwise direction to retract the inner segment open second end within the sleeve.

[0018] In one or more embodiments, the sleeve interior surface further comprises a helical groove for reducing ingress of material into and out of the device.

[0019] In one or more embodiments, the sleeve annular wall has a sleeve length LI1 extending from the open first end to the open second end, the inner segment annular wall has an inner segment length LO1 extending from the closed first end to the open second end, and LI1 is less than LO1.

[0020] In one or more embodiments, connection of the disinfection device to a medical connector compresses the absorbent material within the chamber to disinfect the medicalP-28529.WO01 PATENT connector with the disinfectant or antimicrobial agent while the inner blocking element engages and blocks the tip of the medical connector.

[0021] In one or more embodiments, the female luer connector is selected from the group consisting essentially of needle-free connectors, stopcocks, and hemodialysis connectors.

[0022] In one or more embodiments, the male connector is an intravenous tubing end or stopcock.

[0023] In one or more embodiments, the removable seal comprises an aluminum or multi-layer polymer film peel back top.

[0024] In one or more embodiments, the disinfectant or antimicrobial agent may be selected from the group consisting essentially of isopropyl alcohol, ethanol, 2-propanol, butanol, methylparaben, ethylparaben, propylparaben, propyl gallate, 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.

[0025] In one or more alternate embodiments, the disinfection device includes a sleeve having an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer connector. An inner segment comprising a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having either (a) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more threads adapted to engage a male luer connector or (b) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pins configured to engage with a male luer connector. A chamber is disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment. An absorbent material is disposed within the chamber, the absorbent material containing a disinfectant or antimicrobial agent. An inner blocking element includes an elongate member having a length extending through at least a portion of the absorbent material andP-28529.WO01 PATENT adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

[0026] In one or more embodiments, the elongate member is compressible along at least a portion of its length. In one or more embodiments, the the elongate member comprises a plurality of compressible segments and non-compressible segments along its length. In one or more embodiments, connection of the disinfection device to a medical connector compresses the absorbent material within the chamber to disinfect the medical connector with the disinfectant or antimicrobial agent while the inner blocking element engages and blocks the tip of the medical connector and compresses along its length.

[0027] In one or more alternate embodiments, the disinfection device includes a sleeve having an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer connector. An inner segment includes a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having one or more opposing lugs, luers or pins configured to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pins configured adapted to engage a male luer connector. A chamber is disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment. An absorbent material is disposed within the chamber, the absorbent material containing a disinfectant or antimicrobial agent. An inner blocking element is housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

[0028] In one or more alternate embodiments, the disinfection device includes a sleeve having an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeveP-28529.WO01 PATENT interior surface, the sleeve interior surface having one or more lugs, luers or pins to engage a female luer connector. An inner segment includes a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having one or more opposing threads configured to engage with at lugs, luers or pins on the sleeve interior surface and one or more opposing lugs, luers or pins configured adapted to engage a male luer connector. A chamber is disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment. An absorbent material is disposed within the chamber, the absorbent material containing a disinfectant or antimicrobial agent. An inner blocking element is housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] So that the manner in which the above recited features of the present disclosure can be understood in detail, a more particular description of the disclosure, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this disclosure and are therefore not to be considered limiting of its scope, for the disclosure may admit to other equally effective embodiments. The embodiments as described herein are illustrated by way of example and not limitation in the figures of the accompanying drawings in which like references indicate similar elements.

[0030] Fig. 1A illustrates a bottom perspective view of a device according to one or more ^^^^^^^^^^^^

[0031] Fig.1B illustrates ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

[0032] Figs. 2A illustrates a side cross-sectional view of the device shown in Fig. 1A in a first ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^P-28529.WO01 PATENT

[0033] Fig.2B illustrates a side cross-sectional view of the device shown in Fig.1A in a second position for engagement with a male connector^

[0034] Fig. 3A illustrates a side cross-sectional view of the device shown in Fig. 1A in a first ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

[0035] FIG.3B illustrates a simplified view of the device shown in FIG.3A attached to a female connector^

[0036] FIG.4A illustrates a side cross-sectional view of the device shown in Fig.1A in a second position for engagement with a male connector^

[0037] FIG. 4B illustrates a simplified view of the device shown in FIG. 4A attached to a male ^^^^^^^^^^

[0038] Fig.5A illustrates a side cross-sectional view of the device shown in Fig.1A, with a tortuous path provided on an inner surface of the sleeve in the form of a helical groove.

[0039] Fig.5B illustrates a side cross-sectional view of the device shown in Fig.1A, with an inwardly tapering inner surface of the sleeve and an outwardly tapering outer surface of the inner segment.

[0040] Fig.6A illustrates the device of Fig.1A with a peelable seal on the bottom face of the device.

[0041] Fig.6B illustrates the device of Fig.6A with a top-web extending from the peelable seal to partially cover the device.

[0042] Fig.6C illustrates the device of Fig.6A with a top-web extending from the peelable seal to completely cover the device.

[0043] Fig. 7A illustrates a side cross-sectional view of a device according to one or more embodiments^

[0044] Fig. 7B illustrates a bottom perspective cross-sectional view of a device shown in Fig. ^^^

[0045] Fis. 8A illustrates a side cross-sectional view of the device shown in Fig. 7A in a first ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^

[0046] Fig.8B illustrates a side cross-sectional view of the device shown in Fig.8A attached to ^^^^^^^^^^^^^^^^^^^

[0047] Fig.9A illustrates a side cross-sectional view of the device shown in Fig.7A in a second ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^P-28529.WO01 PATENT

[0048] Fig.9B illustrates a side cross-sectional view of the device shown in Fig.9A with a male connector positioned for attachment^

[0049] Fig. 10A illustrates an exploded perspective view of a device according to one or more ^^^^^^^^^^^^^^^^^^^^^^

[0050] Fig.10B illustrates a side cross-sectional view of the device shown in Fig.10^^

[0051] Fig. 11A illustrates an exploded perspective view of a device according to one or more ^^^^^^^^^^^^^^^^^^^^^^^^^^

[0052] Fig.11B illustrates a side cross-sectional view of the device shown in Fig.11A. DETAILED DESCRIPTION

[0053] 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.

[0054] Embodiments of the disclosure pertain to a universal single-use device for connection to and disinfection of a medical implement with a connector, including male luer connectors and female luer connectors, in which the device comprises an outer sleeve and inner segment. 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.

[0055] With respect to terms used in this disclosure, the following definitions are provided.

[0056] As used herein, the use of “a,” “an,” and “the” includes the singular and plural.

[0057] 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.

[0058] 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,P-28529.WO01 PATENT 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.

[0059] Disinfecting caps currently on the market are typically designed to disinfect only 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, a disinfecting device 100 is provided that is adaptive to different types of luer connectors, thereby allowing a user to clean different types of medical implements with a single device.

[0060] The disinfecting device 100 can fit a broad range of luer fitting, including closed female luer, open female luer, and male luer fittings, while disinfecting medical implements such as access ports including needleless connectors, male connectors on intravenous lines, stopcocks, and hemodialysis connectors. In one or more embodiments described herein, 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 can be an intravenous (I.V.) tubing end, stopcock or male lock luer.

[0061] Referring to Figs.1A-6C, a disinfecting device 100 for connection to a medical connector according to a first exemplary embodiment of the present disclosure generally comprises a sleeve 102, an inner segment 120, an absorbent material 140, and a peelable seal 150.

[0062] In one or more embodiments, as shown in Fig.1B and Fig.3A, the sleeve 102 comprises an open first end 104, an open second end 106, and a sleeve annular wall 108 having a length L01 extending from the open first end 104 to the open second end 106. The sleeve annular wall 108 has a sleeve annular wall outer surface 110 and a sleeve annular wall interior surface 112. According to one or more embodiments, the sleeve annular wall interior surface 112 includes one or more sleeve threads 114 adapted to engage one or more inner segment threads 132. The sleeve annular wall interior surface 112 also includes one or more sleeve threads 116 adapted to engage threads of a female luer connector. According to one or more embodiments, one or moreP-28529.WO01 PATENT threads 116 on the sleeve annular wall interior surface 112 are the same or similar to threads on the inner wall of caps for conventional needle free connectors (e.g., BD PureHubTM) or commercially available caps for needle free connectors). According to one or more embodiments, the height of the threads on the surface 126 may be similar in height as the outer lugs, luer or pins found on commercially available male connector caps. Alternatively, the surface 126 would have similar lugs, luer or pins as those found on commercially available disinfecting caps or hypodermic needles allowing for the two threads (or thread and lugs) to engage with each other. The threads, lugs, luer or pins disposed on the surface 126 are adapted to connect with both female connectors and male connectors, respectively.

[0063] In one or more embodiments, as shown in Fig. 1B, Fig 4A, and 4C, the inner segment 120 comprises a closed first end 122, an open second end 124, and an inner segment annular wall 126 having a length L02extending from the closed first end 122 to the open second end 124. The length L02of the inner segment annular wall 126 is greater than the length L01of the sleeve annular wall 108. The inner segment annular wall 126 has an inner segment annular wall exterior surface 128 and an inner segment annular wall interior wall surface 130. The exterior surface 128 includes one or more threads 132 adapted to engage with one or more threads 114 on the sleeve annular wall interior surface 112. The inner segment annular wall exterior surface 128 also includes one or more threads 134 adapted to engage a male luer connector. According to one or more embodiments, one or more of the threads 132 on the inner segment annular wall 126 are similar in configuration and / or size (e.g. height) to those found on the outer surface of conventional male connector caps.

[0064] In one or more embodiments, as shown in Fig. 2B, the inner segment annular wall 126 which extends from the closed first end 122 to the open second end 124 defines a chamber 146. Fig 2B. illustrates absorbent material 140 disposed in chamber 146 disposed within the inner segment 120. According one or more embodiments, as illustrated in Fig.2B, the chamber 146 is defined generally by the inner segment interior wall surface 130, a first closed end chamber wall 147, and the open second end 124 of the inner segment 120. According to one or more embodiments, the first closed end chamber wall 147 of the chamber 146 includes a protrusion 149 extending into the chamber 146 being sized and shaped to correspond with an opening of a medical implement tip (e.g., a male luer tip), such that when the medical implement tip is inserted into the disinfecting device 100 and connected, the protrusion 149 fits within the medical implement tip opening to block the medical implement tip from contamination or ingress ofP-28529.WO01 PATENT disinfectant or antimicrobial agent (e.g., when the absorbent material 140 is compressed to release the disinfectant or antimicrobial agent).

[0065] The disinfecting device 100 integrates a disinfectant or antimicrobial agent in the chamber 146 of the inner segment 120. The disinfecting device 100 is designed to be compatible with various disinfectants and antimicrobial agents. 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, 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. The disinfectant or antimicrobial agent can be directly included in the chamber 146 or the disinfectant or antimicrobial agent can be absorbed into an absorbent material 140 (e.g., a sponges or foam material) housed within the chamber 146, for example, as illustrated in Figs.1A-6C.

[0066] In one or more embodiments, as shown in Figs.1A-6C, the absorbent material 140 has a first end 142 and a second end 144, the second end 144 having a relatively larger cross-section than the first end 142. In one or more embodiments, the first end 142 is inserted in the chamber 146 until the larger cross-section of the second end 144 abuts the inner segment open second end 124 but does not enter the chamber 146. Thus, in one or more embodiments, the inner segment open second end 124 is at least partially covered by the second end 144 of the absorbent material 140 (e.g., as depicted in Figs. 2A-5). However, the absorbent material 140 is not limited to this configuration. According to alternate embodiments, the absorbent material 140 can be shaped to fit entirely within the chamber 146, with the absorbent material 140 having a second end 144 that is either approximately flush with the inner segment open second end 124 or is recessed within the chamber 146 so a that a horizontal plane P formed by the inner segment open second end 124 protrudes beyond the absorbent material 140 second end 144.

[0067] In one or more embodiments, as illustrated in Figs.1A-5, the absorbent material 140 has an opening or slit 138 in the second end 144. The opening or slit 138 is disposed in the absorbent material 140 second end 144 in a location that corresponds to an entry location for a medical implement tip that will be inserted and disinfected when the disinfecting device 100 is connectedP-28529.WO01 PATENT to an access hub or port with, e.g., male and female luer fittings. For example, as illustrated in Figs. 1A, the opening or slit 138 is disposed in a central portion of the absorbent material 140 second end 144. According to one or more embodiments, the opening or slit 138 extends from the second end 144 toward the first end 142 to form an elongate cut 148 having a length approximately equal to a length of the medical implement tip (e.g., luer tip) being inserted and disinfected. According to one or more embodiments, as illustrated in Fig.2A, Fig.3A, Fig.4A, and Fig. 5, the elongate cut 148 extends along an entire length of the absorbent material 140 from the first end 142 to the second end 144. According to one or more embodiments, the elongate cut 148 extends from the opening or slit 138 along a center of the absorbent material 140 toward the first end 142, for example, as illustrated in Figs. Fig. 2A, Fig. 3A, Fig. 4A, and Fig. 5, which corresponds to a pathway that a medical implement tip will travel when the disinfecting device 100 is attached to the access hub or port.

[0068] In one or more embodiments, the absorbent material 140 compresses toward the first closed end chamber wall 147 upon connection to a medical implement (e.g., a female luer connector or a male luer connector). The compression of the absorbent material 140 disinfects the medical implement.

[0069] In one or more embodiments, a peelable seal 150 is disposed on an open end of the disinfecting device 100 to seal the disinfectant or antimicrobial agent within the disinfecting device 100. According to one or more embodiments, as shown in Figs.6A-6C, the peelable seal 150 is disposed on the sleeve end face 118. According to one or more embodiments, the peelable seal 150 prevents the disinfectant or the antimicrobial agent from exiting the chamber 146. In one or more embodiments, the peelable seal comprises 150 an aluminum or multi-layer polymer film peel back top. In one or more embodiments, the peelable seal 150 comprises a moisture barrier.

[0070] In one or more embodiments, as shown in Figs.6B-6C, additional packaging is provided to partially or fully cover the disinfecting device 100 to reduce loss of disinfectant or antimicrobial agent (e.g. IPA loss) from the disinfecting device 100 prior to use. For example, disinfectant or antimicrobial agent loss can occur through any gaps between the sleeve 102 and the inner segment 120 prior to use (i.e. during the shelf life of the product). As illustrated in Fig. 6B, in addition to the peelable seal 150, a top-web covering 162 can extend from the peelable seal 150 to cover a portion of the disinfecting device 100. For example, this top-web covering 162 can extend to cover at least a portion of the disinfecting device 100 where the sleeve 102P-28529.WO01 PATENT and the inner segment 120 meet, as depicted in Fig. 6B wherein the top-web covering extends beyond where the sleeve open first end 104 overlaps the inner segment 120. In one or more embodiments, a top web-covering 162 can extend over and enclose the entire disinfecting device 100, either extending from the peelable seal 150 and over the entire disinfecting device 100 (as depicted in Fig. 6C) or enclosing the peelable seal and the entire disinfecting device 100. The top-web covering 162 can be fabricated of any conventional airtight sealing materials designed to prevent loss of disinfectant or antimicrobial agents. In some embodiments, the top-web covering 162 is fabricated of the same or similar materials used in forming the peelable seal 150, including aluminum and multi-layer polymer films. In one or more embodiments, rather than or in addition to providing a top-web covering 162, any gaps between the sleeve 102 and inner segment 120 are sealed, for example, using a silicon O-ring or a gel to prevent the evaporation of disinfectant or antimicrobial agents prior to use of the device 100.

[0071] When the disinfecting device 100 is removed from any packaging enclosing the disinfecting device 100 (e.g. top-web covering 162 or any other packaging materials), the disinfecting device 100 is provided in a position with the sleeve end face 118 positioned in a horizontal plane P relative to the inner segment 120 open second end 124 such that the inner segment 120 does not protrude beyond the sleeve end face 118. For example, according to one or more embodiments, the sleeve end face 118 can be positioned in approximately a same horizontal plane P as the inner segment 120 open second end 124. As used herein, the use of the phrase “approximately a same horizontal plane P” refers to a position in which the sleeve end face 118 and the inner segment 120 open second end 124 are close to each other but the inner segment 120 open second end 124 does not protrude beyond the sleeve end face 118. According to one or more embodiments, when the disinfecting device 100 is removed from any packaging, the inner segment 120 open end 124 is at least partially retracted within the sleeve 102 such that the sleeve end face 118 is close to but protrudes beyond the inner segment 120 open second end 124.

[0072] According to one or more embodiments, the absorbent material 140 has a second end 144 that abuts the inner segment open second end 124 and at least partially covers the inner segment open second end 124 (e.g., as depicted in Figs. 2A-5), so that when the disinfecting device 100 is removed from any packaging, the disinfecting device 100 can be provided in a position with the sleeve end face 118 in approximately a same horizontal plane P as the absorbent material second end 144 (e.g., as illustrated in Fig. 1A). As used herein, the use of the phraseP-28529.WO01 PATENT “approximately a same horizontal plane P” refers to a position in which the sleeve end face 118 and the absorbent material second end 144 are close to each other but the absorbent material second end 144 does not protrude beyond the sleeve end face 118. According to one or more embodiments, when the disinfecting device 100 is removed from any packaging, the inner segment 120 is partially retracted within the sleeve 102 such that the sleeve end face 118 protrudes beyond the absorbent material second end 144 (e.g., as illustrated in Fig.2A and 6B).

[0073] Fig.2A and Fig.2B illustrate the disinfecting device 100 in a first position (Fig.2A) for connection to a female luer connector and in a second position (Fig.2B) for connection to a male luer connector, according to one or more embodiments.

[0074] To connect the disinfecting device 100 to a female luer connector, depending on the position of the sleeve 102, the user first positions the sleeve 102 in the appropriate position relative to the inner segment 120 as needed. If the sleeve 102 is positioned toward the inner segment closed first end 122 (e.g. as illustrated in Fig. 2B), the user rotates the sleeve 102 counter-clockwise to move the sleeve 102 toward the inner segment open second end 124 until the sleeve 102 is in the first position (Fig.2A) or approximately in the first position. On the other hand, if the sleeve 102 is positioned too far beyond the inner segment open second end 124, the user rotates the sleeve 102 clockwise to move the sleeve 102 toward the inner segment closed first end 122 until the disinfecting device 100 is in the first position (Fig.2A) or approximately in the first position. As used herein when referring to attachment to a female luer connector, the use of the phrase “too far beyond the inner segment open second end 124” generally refers to a position in which insertion of a female luer connector (screwing the disinfecting device 100 onto the female connector threads) might not result in the required portion(s) of the medical implement coming into contact with the disinfectant and antimicrobial agent / absorbent material 140 for disinfection / sterilization. In some embodiments, the phrase “too far beyond the inner segment open second end 124” can refer to a position in which the sleeve 102 is positioned with the second end 106 spaced a greater distance from the absorbent material second end 144 (or the inner segment open second end 124) than that shown by the first position (Fig.2A). According to some embodiments, small variations in sleeve 102 position relative to the first position shown in Fig. 2A are acceptable as long as the disinfecting device 100 can be attached to the female luer connector and the medical implement can contact the disinfectant and antimicrobial agent / absorbent material 140 for disinfection / sterilization. The disinfecting device 100 is then attached to the female connector by inserting the female connector into the sleeve 102 openP-28529.WO01 PATENT second end 106 so that the sleeve threads 116 engage threads of the female connector, and rotating the disinfecting device 100 to screw the disinfecting device 100 onto the female connector threads (or rotating the female connector the screw the female connector into the threads 116 of the sleeve 102). A simplified view of the disinfecting device 100 attached to a female connector 164 is shown in Fig. 3B, with the female connector 164 disposed within a bottom portion of the sleeve 102 and retained by engagement between the threads 116 of the sleeve 102 and the threads of the female connector 164. A user can subsequently remove the disinfecting device 100 from the female connector by rotation in the opposite direction (and / or disengaging the one or more lugs and / or luers), leaving the sleeve 102 and inner segment 120 intact.

[0075] To connect the disinfecting device 100 to a male luer connector, depending on the position of the sleeve 102, the user first positions the sleeve 102 in the appropriate position relative to the inner segment 120 as needed. If the sleeve 102 is positioned too far toward the inner segment open second end 124 relative to the second position (Fig.2B) (e.g., as illustrated in Fig. 2A), the user rotates the sleeve 102 clockwise to move the sleeve 102 toward the inner segment closed first end 122 until the disinfecting device 100 is at or near the second position (Fig. 2B). As used herein when referring to attachment to a male luer connector, the use of the phrase “too far toward the inner segment open second end 124” refers to a position in which the sleeve 102 covers a bottom portion of the inner segment 120 that needs to be exposed to allow secure attachment of a male connector to the inner segment 120, and / or a position of the sleeve 102 that might not result in the portion(s) of the medical implement to contact the disinfectant and antimicrobial agent / absorbent material 140 and become disinfected / sterilized. On the other hand, if the sleeve 102 is positioned too far toward the inner segment closed first end 122, the user rotates the sleeve 102 counter-clockwise to move the sleeve 102 toward the inner segment open second end 124 until it is at or near the second position (Fig.2B). According to one or more embodiments, a flange 136 is disposed toward the inner segment closed first end 122 which prevents the sleeve 102 from moving beyond the inner segment closed first end 122. In the second position (e.g., Fig.2B), a bottom portion of the inner segment 120 protrudes beyond the sleeve second end 106, with one or more threads 134 on the inner segment exterior wall surface 128 exposed for attachment to the male luer connector. The disinfecting device 100 is then attached to the male luer connector by inserting a bottom portion of the inner segment 120 into the male luer connector so that the inner segment threads 134 engage threads of the maleP-28529.WO01 PATENT connector, and rotating the disinfecting device 100 to screw the disinfecting device 100 onto the male connector threads (or rotating the male connector the screw the male connector onto the inner segment threads 134). A simplified view of the disinfecting device 100 attached to a male connector 168 is shown in Fig. 4B, with the male connector 168 disposed around and within a bottom portion of the inner segment 120 and retained by engagement between the inner segment threads 134 and the threads of the male connector 168. A user can subsequently remove the disinfecting device 100 from the male luer connector by rotation in the opposite direction (and / or disengaging the one or more lugs and / or luers), leaving the sleeve 102 and inner segment 120 intact.

[0076] When the threads 134 (and / or lugs / luers), of the inner segment 120 are engaged with a male luer connector, the threads 116 (and / or lugs / luers) of the sleeve will be passive. Alternatively, when the threads 116 (and / or lugs / luers) of the sleeve 102 are engaged with a female luer connector, the threads 134 (and / or lugs / luers) of the inner segment 120 will be passive.

[0077] According to one or more embodiments, as shown for example in Fig.5A, a tortuous path 160 is provided on an inner surface of the sleeve in the form of a helical groove. The tortuous path reduces or minimizes entry of contaminants into the disinfecting device 100 during shelf life. According to one or more embodiments, as shown for example in Fig.5B, a lower end of the inner segment 120 is tapered outward (as illustrated by the Arrow “A”) to prevent the sleeve 102 from disconnecting from the inner segment 120. According to one or more embodiments, the upper end of the sleeve 102 is tapered inward (as illustrated by the Arrow “B”) to support the sleeve 102 on the inner segment 120 and prevent the sleeve from disconnecting from the inner segment 120. As such, the sleeve 102 can further be prevented from movement relative to the inner segment 120 while not in use (e.g., while packaged prior to use).

[0078] In one or more embodiments, the absorbent material 140 compresses toward the inner segment closed first end 122 within the chamber 146 upon connection to the female luer connector or the male luer connector. The compression of the absorbent material 140, which contains the disinfectant or antimicrobial agent, releases the agent to disinfect the medical implement (e.g., female luer connector or the male luer connector).

[0079] According to one or more embodiments, the inner segment 120 and / or the sleeve 102 is made from any of a number of types of plastic materials such as polycarbonate, polypropylene,P-28529.WO01 PATENT polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene or any other moldable plastic material used in medical devices.

[0080] In one or more embodiments, the sleeve outer surface 110 can be provided with a plurality of grip members (not shown) to facilitate gripping and rotation of the sleeve 102 relative to the inner segment 120.

[0081] Referring to Figs.7A-9B, a disinfecting device 200 for connection to a medical connector according to a second exemplary embodiment of the present disclosure is illustrated. All of the features, materials, configuration, and general details of the disinfecting device 200 according to the second exemplary embodiment are in accordance with the first exemplary embodiment described in connection with Figs. 1A-6C, but further includes an inner blocking element 252. Thus, the details in connection with the first exemplary embodiment described herein and in connection with Figs. 1A-6C apply to the disinfecting device 200 second exemplary embodiment.

[0082] According to one or more embodiments, the disinfecting device 200, as illustrated in Figs.7A-9B generally comprises a sleeve 202, an inner segment 220, an absorbent material 240, and a peelable seal (not shown). Similar to the configuration of the disinfecting device 100 of the first exemplary embodiment, the sleeve 202 comprises an open first end 204, an open second end 206, and a sleeve annular wall 208 having a length L01extending from the open first end 204 to the open second end 206. The sleeve annular wall 208 has a sleeve annular wall outer surface 210 and a sleeve annular wall interior surface 212. The sleeve annular wall interior surface 212 includes one or more sleeve threads 214 adapted to engage one or more inner segment threads 232. The sleeve annular wall interior surface 212 also includes one or more sleeve threads 216 adapted to engage threads of a female luer connector.

[0083] In one or more embodiments, as shown in Figs.7A-9B, the inner segment 220 comprises a closed first end 222, an open second end 224, and an inner segment annular wall 226 having a length L02 extending from the closed first end 222 to the open second end 224. The length L02 of the inner segment annular wall 226 is greater than the length L01 of the sleeve annular wall 208. The inner segment annular wall 226 has an inner segment exterior wall surface 228 and an inner segment interior wall surface 230. The inner segment exterior wall surface 228 includes one or more threads 232 adapted to engage with one or more threads 214 on the sleeve annular wall interior surface 212. The inner segment exterior wall surface 228 also includes one or more threads 234 adapted to engage a male luer connector.P-28529.WO01 PATENT

[0084] In one or more embodiments, the inner segment annular wall 220 which extends from the closed first end 222 to the open second end 224 defines a chamber 246 within the inner segment 220. According one or more embodiments, the chamber 246 is defined generally by the inner segment interior wall surface 230, a first closed end 247, and the inner segment open second end 224.

[0085] The disinfecting device 200 integrates a disinfectant or antimicrobial agent in the chamber 246 of the inner segment 220. The disinfectant or antimicrobial agent can be directly included in the chamber 246 or the disinfectant or antimicrobial agent can be absorbed into an absorbent material 240 (e.g., a sponges or foam material) housed within the chamber 246, for example, as illustrated in Figs.7A-9B. The disinfecting device 200 is designed to be compatible with various disinfectants and antimicrobial agents. 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, 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.

[0086] In one or more embodiments, as shown in Figs.7A-7B, the absorbent material 240 has a first end 242 and a second end 244, the second end 244 having a relatively larger cross-section than the first end 242. In one or more embodiments, the first end 242 is inserted in the chamber 246 until the larger cross-section of the second end 244 abuts the inner segment open second end 224 but does not enter the chamber 246. Thus, in one or more embodiments, the inner segment open second end 224 is at least partially covered by the second end 244 of the absorbent material 240 (e.g., as depicted in Figs.7A-7B). However, the absorbent material 240 is not limited to this configuration. According to alternate embodiments, the absorbent material 240 can be shaped to fit entirely within the chamber 246, with the absorbent material 240 having a second end 244 that is either approximately flush with the inner segment open second end 224 or is recessed within the chamber 246 so a that a horizontal plane P formed by the inner segment open second end 224 protrudes beyond the absorbent material 240 second end 244.P-28529.WO01 PATENT

[0087] In one or more embodiments, the absorbent material 240 has an opening 238 in the second end 244. The opening 238 is disposed in the absorbent material 240 second end 244 in a location that corresponds to an entry location for a medical implement that will be inserted and disinfected when the disinfecting device 200 is connected to an access hub or port with, e.g., male and female luer fittings. For example, as illustrated in Figs.7A-9B, the opening 238 can be disposed in a central portion of the absorbent material 240 second end 244. According to one or more embodiments, the opening 238 extends from the second end 244 toward the first end 242 to form an elongate channel 248. According to one or more embodiments, as illustrated in Figs. 7A-9B, the elongate channel 248 extends along an entire length of the absorbent material 240 from the first end 242 to the second end 244. According to one or more embodiments, the elongate channel 248 extends from the opening 238 along a center of the absorbent material 240 toward the first end 242, which corresponds to a pathway that a luer tip (or other portion of a medical implement) will travel when the disinfecting device 200 is attached to the access hub or port.

[0088] According to one or more embodiments, for example as illustrated in Fig. 7A and Fig. 7B, an inner blocking element 252 is an elongate member that extends within at least a portion of the elongate channel 248. According to some embodiments, the inner blocking element 252 extends within an entire length of the elongate channel 248 (e.g., as shown in Figs.7A-9B), with a first end 254 abutting a first closed end 247 of the chamber 246 and a second end 256 being flush or approximately flush with the second end 244 of the absorbent materials 240. Alternatively, the inner blocking element 252 can extend along less than the entire length of the elongate channel 248. For example, according to one or more embodiments, the inner blocking element 252 has a second end 256 that is flush or approximately flush with the second end 244 of the absorbent materials 240 and extends toward but does not abut the first closed end 247 of the chamber 246. According to one or more embodiments, the inner blocking element 252 has a second end 256 that is recessed within the elongate channel 248 so that the second end 244 of the absorbent materials 240 protrudes beyond the second end 256 of the inner blocking element 252, and the inner blocking element 252 extends within the elongate channel 248 toward the first closed end 247 of the chamber 246 to either abut the first closed end 247 or to extend a distance towards the first closed end 247 but not make contact with the first closed end 247 of the chamber 246. The elongate channel 248 and inner blocking element 252 are disposed within theP-28529.WO01 PATENT disinfecting device 200 in a position that corresponds to a pathway that a luer tip (or other portion of a medical implement) will travel when the disinfecting device 200 is attached to the access hub or port.

[0089] According to one or more embodiments, the inner blocking element 252 has a second end 256 that is sized and shaped to correspond with an opening of a medical implement (e.g., a female or male luer tip), such that when a medical implement is inserted into the disinfecting device 200, the second end 256 fits within the opening (e.g., fits within the female or male luer tip opening) to block the opening from contamination or ingress of disinfectant or antimicrobial agent (e.g., when the absorbent material 240 is compressed to release the disinfectant or antimicrobial agent). As illustrated in Figs.2A-9B, the inner blocking element 252 is configured with an overall elongate shape comprising alternating non-compressible segments 258 and compressible segments 260. As such, connection to a medical implement results in the medical implement tip (e.g., female or male luer tip) contacting the second end 256 of the inner blocking element 252, and the second end 256 entering and / or closing off an opening in the medical implement tip. For example, as illustrated in Fig.8B, connection of the disinfecting device 200 to a female connector 262 results in a female connector opening coming into contact with and becoming blocked by the second end 256 of the inner blocking element 252. Similarly, as illustrated in Fig.9B, connection of the disinfecting device 200 to a male connector 266 results in a male connector opening coming into contact with and becoming blocked by the second end 256 of the inner blocking element 252.

[0090] While the inner blocking element 252 is illustrated having an overall elongate shape comprising alternating non-compressible segments 258 and compressible segments 260, the inner blocking element 252 is not limited to this configuration. Rather, the inner blocking element 252 can be provided in any configuration that allows for compression along its length, including for example, a helical shape along its length, segments of soft and hard materials along the length, or by fabricating the inner blocking element 252 of a material that can buckle and reduce its length progressively and reversibly upon application of pressure and / or as the applied pressure increases. Further, in some embodiments, compression of the inner blocking element 252 might not be required and, as such, the inner blocking element 252 can be provided as an elongate element without compression along its length.

[0091] In one or more embodiments, the inner blocking element 252 is made from any of a number of types of materials including, for example, plastic materials such as polycarbonate,P-28529.WO01 PATENT polypropylene, polyethylene, glycol-modified polyethylene terephthalate, acrylonitrile butadiene styrene, thermoplastic elastomer, thermoplastic vulcalizate, cross-linked rubber, or any other moldable plastic material used in medical devices. In one or more embodiments, the compressible segments 260 are formed of a more flexible material relative to the material forming the non-compressible segments 258, which provides for compression along the compressible segments 260. In such embodiments, the non-compressible segments 258 and compressible segments 260 would not necessarily be provided with different sizes as depicted. According to one or more embodiments, the compressible segments 260 and non-compressible segments 258 are formed of the same material, and the compressible segments 260 are formed relatively thinner than the non-compressible segments 258 to provide compression along the compressible segments 260. Without being bound by theory, by providing varying compressible segments 260 and non-compressible segments 258 along the length of the inner blocking element, the overall elongate and linear length of the inner blocking element 252 within the absorbent material 240 is maintained through the structural integrity of the non-compressible segments 258, and bending of the inner blocking element into a curved shape within the absorbent material 240 is reduced or prevented.

[0092] In one or more embodiments, the absorbent material compresses toward the first closed end 247 of the chamber 246 upon connection to the female luer connector or the male luer connector. The compression of the absorbent material releases the disinfectant or antimicrobial agent from the absorbent material to disinfect the medical implement.

[0093] According to one or more embodiments, the inner blocking element 252 also compresses along its length upon connection to the female luer connector or the male luer connector. The inner blocking element 252 can be configured and arranged to compress along its length to an extent that allows insertion of the medical implement tip within the disinfecting device 200, particularly so that the medical implement tip comes into contact with the absorbent material 240 and the released disinfectant or antimicrobial agent for disinfection / sterilization.

[0094] In one or more embodiments, the inner blocking element 252 can be configured to extend from a second end 244 of the absorbent materials 240 toward (without making contact with) the first closed end 247 of the chamber 246. As the disinfecting device 200 is connected to a medical implement, the second end 256 of the inner blocking element 252 makes contact with, enters and / or blocks an opening of the medical implement. The inner blocking element 252 can then slide within the elongate channel 248 toward the first closed end 247 of the chamber 246. In oneP-28529.WO01 PATENT or more embodiments, the inner blocking element 252 can further engage the first closed end 247 of the chamber 246 and compress, if needed.

[0095] Fig.7A illustrates the disinfecting device 200 in a first position for connection to a female connector 262, according to one or more embodiments. To connect the disinfecting device 200 to a female connector, depending on the initial position of the sleeve 202, the user first positions the sleeve 202 in the appropriate position relative to the inner segment 220 as needed and as described in connection with the disinfecting device 100 according to the first exemplary embodiment (i.e., by rotating the sleeve 202 counter-clockwise or clockwise). The disinfecting device 200 is then attached to the female connector 262, for example as illustrated in Fig. 8B, by inserting the female connector 262 into the sleeve 202 open second end 206 so that the sleeve threads 216 engage threads of the female connector 262, and rotating the disinfecting device 200 to screw the disinfecting device 200 onto the female connector threads (or rotating the female connector 262 to screw the female connector 262 into the threads 216 of the sleeve 202). A user can subsequently remove the disinfecting device 200 from the female connector 262 by rotation in the opposite direction, leaving the sleeve 202 and inner segment 220 intact. According to one or more embodiments, as further described in connection with disinfecting device 100, the sleeve 102 has at least one lug or luer, or a combination of threads and lugs or luers, disposed thereon to engage with the female connector.

[0096] Fig. 7B illustrates the disinfecting device 200 in a second position for connection to a male connector, 266 according to one or more embodiments. To connect the disinfecting device 200 to a male connector 266, depending on the initial position of the sleeve 202, the user first positions the sleeve 202 in the appropriate position relative to the inner segment 220 as needed and as described in connection with the disinfecting device 100 according to the first exemplary embodiment (i.e., by rotating the sleeve 202 counter-clockwise or clockwise). The disinfecting device 200 is then attached to the male connector 266, for example as illustrated in Fig. 9B, by inserting a bottom portion of the inner segment 220 into the male connector 266 so that the inner segment threads 234 engage threads of the male connector 266 and rotating the disinfecting device 200 to screw the disinfecting device 200 onto the male connector threads (or rotating the male connector 266 to screw the male connector 266 onto the inner segment threads 234). A user can subsequently remove the disinfecting device 200 from the male connector 266 by rotation in the opposite direction, leaving the sleeve 202 and inner segment 220 intact. According to one or more embodiments, as further described in connection with disinfecting device 100, the innerP-28529.WO01 PATENT segment 220 has at least one lug or luer, or a combination of threads and lugs or luers, disposed thereon to engage with the male connector.

[0097] When the threads 234 (or combination of threads, lugs, and / or luers) of the inner segment 220 are engaged with a male connector 266, the threads 216 (or combination of threads, lugs 327, pins and / or luers) of the sleeve will be passive. Alternatively, when the threads 216 (or combination of threads, lugs, and / or luers) of the sleeve 202 are engaged with a female connector 262, the threads 234 (or combination of threads, lugs, and / or luers) of the inner segment 220 will be passive.

[0098] In one or more embodiments, the absorbent material 240 compresses toward the inner segment closed first end 222 within the chamber 246 when connected to the female connector or the male connector. The compression of the absorbent material 240, which contains the disinfectant or antimicrobial agent, releases disinfectant or antimicrobial agent to disinfect the medical implement.

[0099] According to one or more embodiments, the inner segment 220 and / or the sleeve 202 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.

[0100] In one or more embodiments, the sleeve annular wall outer surface 210 can be provided with a plurality of grip members (not shown) to facilitate gripping and rotation of the sleeve 202 relative to the inner segment 220.

[0101] According to one or more alternate embodiments, the inner segment annular wall has at least one lug or luer, or a combination of threads and lugs or luers, disposed thereon to engage with the male connector. According to one or more embodiments, the sleeve has at least one lug or luer, or a combination of threads and lugs or luers, disposed thereon to engage with the female connector. As shown in Figs.10A, 10B, 11A and 11B, the inner segment annular wall 326 has at least one lug, luer or pin 327 similar to conventional disinfecting caps or hypodermic needles. According to one or more embodiments, one or more threads (316, 334), or a combination of threads and lugs (327) or luers, are disposed on the inner segment annular wall 326 and the sleeve annular wall interior surface 312 and are configured to engage with each-other during the shelf life of the disinfecting device 300, and to engage with female and male connectors during use.P-28529.WO01 PATENT

[0102] In one or more alternate embodiments, shown in Figs.10A and 10B, disinfection device 300 includes a sleeve 302 having an open first end 304, an open second end 306, and a sleeve annular wall 308 extending from the open first end 304 to the open second end 306. The sleeve annular wall 308 having a sleeve outer surface 310 and a sleeve interior surface 312, the sleeve interior surface 312 having one or more threads 314, at least one of the one or more threads 314 adapted to engage a female luer connector. An inner segment 320 includes a closed first end 322, an open second end 324, an inner segment annular wall 326 extending from the closed first end 322 to the open second end 324, the inner segment annular wall having an inner segment interior surface 330 and an inner segment exterior surface 328 , the inner segment exterior surface 328 having one or more opposing lugs 327, luers or pins configured to engage with at least one of the one or more threads (314) on the sleeve interior surface and one or more opposing lugs 327, luers or pins configured adapted to engage a male luer connector. A chamber 346 is disposed in the inner segment 320 and defined by the inner segment interior surface 330, a chamber wall proximal the closed first end 347 of the inner segment 320, and the open second end 324 of the inner segment. An absorbent material 340 is disposed within the chamber 346, the absorbent material 340 containing a disinfectant or antimicrobial agent. An inner blocking element 349 is housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber 346.

[0103] In one or more alternate embodiments, shown Figs.11A and 11B, disinfection device 400 includes a sleeve 402 having an open first end 404, an open second end 406, and a sleeve annular wall 408 extending from the open first end 404 to the open second end 406, the sleeve annular wall 408 having a sleeve outer surface 410 and a sleeve interior surface 412, the sleeve interior surface 412 having one or more lugs 427, luers or pins to engage a female luer connector. An inner segment 420 includes a closed first end 422, an open second end 424, an inner segment annular wall 426 extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface 430 and an inner segment exterior surface 428, the inner segment exterior surface 428 having one or more opposing threads 414 / 434 configured to engage with at lugs, luers or pins on the sleeve interior surface and one or more opposing lugs, luers or pins configured adapted to engage a male luerP-28529.WO01 PATENT connector. A chamber 446 is disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment. An absorbent material 440 is disposed within the chamber 446, the absorbent material 440 containing a disinfectant or antimicrobial agent. An inner blocking element may be housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector. A removable seal is disposed on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

[0104] In one or more embodiments, the disinfecting 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 disinfecting device 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 disinfecting device.

[0105] 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 disinfecting device 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 disinfecting device has been coupled with the 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 disinfecting device. Use of the disinfecting device replaces the standard swabbing protocol for cleaning connectors.

[0106] In one or more embodiments, threads of the disinfecting device 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.P-28529.WO01 PATENT

[0107] 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.

[0108] 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.

Claims

P-28529.WO01 PATENT WHAT IS CLAIMED IS:

1. A disinfection device for connection to a medical connector, the disinfection device comprising: a sleeve comprising an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer connector^ an inner segment comprising a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having either (a) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more threads adapted to engage a male luer connector or (b) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pins configured to engage with a male luer connector^ a chamber disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open second end of the inner segment^ an absorbent material disposed within the chamber, the absorbent material containing a disinfectant or antimicrobial agent^ an inner blocking element at least partially housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent into the tip opening of the medical connector^^^^^ a removable seal on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

2. The disinfecting device of claim 1, wherein the absorbent material has a first end proximal the chamber wall, a second end proximal the inner segment open second end, and an opening disposed in the absorbent material second end and extending toward the absorbent material first end, the opening adapted to correspond to a tip of a medical connector.P-28529.WO01 PATENT 3. The disinfection device of claim 2, wherein the absorbent material second end has a cross-section larger than the absorbent material first end, the absorbent material fist end is disposed within the chamber, and the absorbent material second end is disposed outside of the chamber abutting the inner segment open second end.

4. The disinfecting device of claim 1, wherein the inner blocking element comprises a protrusion extending from the chamber wall toward the inner segment open second end.

5. The disinfecting device of claim 3, wherein the inner blocking element comprises an elongate member having a length extending through at least a portion of the opening between the absorbent material second end and absorbent material first end.

6. The disinfecting device of claim 5, wherein the elongate member has a first end proximal to or abutting the chamber wall and a second end proximal to the absorbent material second end, the elongate member second end adapted to engage and block a tip opening of the medical connector.

7. The disinfecting device of claim 5, wherein the elongate member is compressible along at least a portion of its length.

8. The disinfecting device of claim 7, wherein the elongate member comprises a plurality of compressible segments and non-compressible segments along its length.

9. The disinfecting device of claim 1, wherein the open end of the inner segment is on approximately a same horizontal plane P as the open second end of the sleeve in an initial state.

10. The disinfecting device of claim 1, wherein the open end of the inner segment is on approximately a same horizontal plane P as the absorbent material second end in an initialP-28529.WO01 PATENT 11. The disinfecting device of claim 1, wherein when a male luer connector is engaged to the one or more threads of the sleeve interior surface, the inner segment open second end is retracted within the sleeve with the one or more threads on of the sleeve interior surface exposed. The disinfecting device of claim 1, wherein when a female luer connector is engaged to the one or more threads of the inner segment exterior surface, the inner segment partially protrudes out from the open second end of the sleeve.

14. The disinfecting device of claim 9, wherein the sleeve is rotated in a counter clockwise direction to protrude the inner segment open second end out from the open second end of the sleeve, and the sleeve is rotated in a clockwise direction to retract the inner segment open second end within the sleeve.

13. The disinfecting device of claim 1, wherein the sleeve interior surface further comprises a helical groove for reducing ingress of material into and out of the device.

14. The disinfecting device of claim 1, wherein the sleeve annular wall has a sleeve length LI1extending from the open first end to the open second end, the inner segment annular wall has an inner segment length LO1extending from the closed first end to the open second end, and LI1is less than LO1.

15. The disinfecting device of claim 1, wherein connection of the disinfection device to a medical connector compresses the absorbent material within the chamber to disinfect the medical connector with the disinfectant or antimicrobial agent while the inner blocking element engages and blocks the tip of the medical connector.

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

17. The disinfecting device of claim 1, wherein the male connector is an intravenous tubing end or stopcock.P-28529.WO01 PATENT 18. The disinfecting device of claim 1, wherein the removable seal comprises an aluminum or multi-layer polymer film peel back top.

19. The disinfecting 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.

20. A disinfection device for connection to a medical connector, the disinfection device comprising: a sleeve comprising an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer ^^^^^^^^^^ an inner segment comprising a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having either (a) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more threads adapted to engage a male luer connector or (b) one or more threads to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pins ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a chamber disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^P-28529.WO01 PATENT an absorbent material disposed within the chamber, the absorbent material containing a ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ an inner blocking element comprising an elongate member having a length extending through at least a portion of the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or antimicrobial agent ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a removable seal on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

21. The disinfecting device of claim 20, wherein the elongate member is compressible along at least a portion of its length.

22. The disinfecting device of claim 21, wherein the elongate member comprises a plurality of compressible segments and non-compressible segments along its length.

23. The disinfecting device of claim 21, wherein connection of the disinfection device to a medical connector compresses the absorbent material within the chamber to disinfect the medical connector with the disinfectant or antimicrobial agent while the inner blocking element engages and blocks the tip of the medical connector and compresses along its length.

24. A disinfection device for connection to a medical connector, the disinfection device comprising: a sleeve comprising an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or more threads, at least one of the one or more threads adapted to engage a female luer ^^^^^^^^^^ an inner segment comprising a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having one or more opposing lugs, luers or pins configuredP-28529.WO01 PATENT to engage with at least one of the one or more threads on the sleeve interior surface and one or more opposing lugs, luers or pinsess configured ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a chamber disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ an absorbent material disposed within the chamber, the absorbent material containing a ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ an inner blocking element housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a removable seal on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

25. A disinfection device for connection to a medical connector, the disinfection device comprising: a sleeve comprising an open first end, an open second end, and a sleeve annular wall extending from the open first end to the open second end, the sleeve annular wall having a sleeve outer surface and a sleeve interior surface, the sleeve interior surface having one or ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ an inner segment comprising a closed first end, an open second end, an inner segment annular wall extending from the closed first end to the open second end, the inner segment annular wall having an inner segment interior surface and an inner segment exterior surface, the inner segment exterior surface having one or more opposing threads configured to engage with at lugs, luers or pins on the sleeve interior surface and one or more opposing lugs, luers or ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a chamber disposed in the inner segment and defined by the inner segment interior surface, a chamber wall proximal the closed first end of the inner segment, and the open ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ an absorbent material disposed within the chamber, the absorbent material containing a ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^P-28529.WO01 PATENT an inner blocking element housed within the absorbent material and adapted to engage and block a tip opening of the medical connector to prevent ingress of the disinfectant or ^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^^ a removable seal on the sleeve open second end to prevent the disinfectant or the antimicrobial agent from exiting the chamber.

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