AU2013345415A1 - Antimicrobial devices for use with medical devices, medical device assemblies and related methods - Google Patents

Antimicrobial devices for use with medical devices, medical device assemblies and related methods Download PDF

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Publication number
AU2013345415A1
AU2013345415A1 AU2013345415A AU2013345415A AU2013345415A1 AU 2013345415 A1 AU2013345415 A1 AU 2013345415A1 AU 2013345415 A AU2013345415 A AU 2013345415A AU 2013345415 A AU2013345415 A AU 2013345415A AU 2013345415 A1 AU2013345415 A1 AU 2013345415A1
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AU
Australia
Prior art keywords
antimicrobial
medical device
syringe
coupling
medical
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Abandoned
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AU2013345415A
Inventor
Aaron Garcia Faulkner
Joel K. Faulkner
Li Min She
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Health Line International Corp
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Health Line International Corp
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Publication date
Application filed by Health Line International Corp filed Critical Health Line International Corp
Publication of AU2013345415A1 publication Critical patent/AU2013345415A1/en
Priority to AU2015100123A priority Critical patent/AU2015100123A4/en
Abandoned legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/18Methods or apparatus for making the connection under sterile conditions, i.e. sterile docking
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10Tube connectors; Tube couplings
    • A61M39/16Tube connectors; Tube couplings having provision for disinfection or sterilisation
    • A61M39/162Tube connectors; Tube couplings having provision for disinfection or sterilisation with antiseptic agent incorporated within the connector

Abstract

Antimicrobial devices include a disinfecting portion comprising a chamber including an amount of antimicrobial substance and a coupling portion configured to secure the antimicrobial device to at least a portion of a medical device. Medical device assemblies include an antimicrobial device coupled to a needle hub of a syringe. Methods of disinfecting a portion of a device include removing an antimicrobial device from a first device and cleaning a portion of a second device.

Description

WO 2014/077906 PCT/US2013/047159 ANTIMICROBIAL DEVICES FOR USE WITH MEDICAL DEVICES, MEDICAL DEVICE ASSEMBLIES AND RELATED METHODS 5 PRIORITY CLAIM This application claims the benefit of the filing date of United States Provisional Patent Application Serial No. 61/728,159, filed November 19, 2012, for "ANTIMICROBIAL DEVICES FOR USE WITH MEDICAL DEVICES, MEDICAL DEVICE ASSEMBLIES AND RELATED METHODS," the disclosure of which is hereby incorporated 10 herein in its entirety by this reference. TECHNICAL FIELD The disclosure generally relates to medical devices generally and antimicrobial devices for use with medical devices and related assemblies and 15 methods. In particular, embodiments of the disclosure relate to antimicrobial devices that are configured to be initially coupled to a medical device and utilized in disinfecting at least a portion of a medical device, such as, one or more portions of a medical device for delivering fluid to and/or sampling fluid from a subject. 20 BACKGROUND In the medical field and, in particular, within the area of delivery of fluids to a subject and removal of fluids from a subject, a need exists to prevent the transmission of pathogens into or onto a subject from a potentially contaminated surface of a medical device. Such pathogens include microorganisms such as bacteria and viruses. 25 For example, bloodstream infections, which may be caused by microorganisms that enter patients via intravascular catheters, are a significant cause of illness and excess medical costs and may result in serious infections or death. Traditionally, cleaning a potentially contaminated surface of a medical device includes treating the surface with an alcohol swab. Such alcohol swabs include cotton 30 gauze soaked in, e.g., isopropyl alcohol or ethanol. The swab is typically applied by a healthcare provider and wiped across a surface of the medical device. As the alcohol applied by the pad dries, it destroys microorganisms. Impregnating medical devices, such as catheters, with various other known antimicrobial agents is another approach for reducing the chances of contamination of the medical device.
WO 2014/077906 PCT/US2013/047159 -2 Other devices comprising a cap for cleaning a medical device include United States Patent Application Publication No. US 2007/0112333 to Hoang et al., published May 17, 2007; United States Patent 7,780,794 to Rogers et al., issued August 24, 2010; United States Patent Application Publication No. US 2011/0044850 5 to Solomon et al., published February 24, 2011; United States Patent Application Publication No. US 2011/0217212 to Solomon et al., published September 8, 2011; and United States Patent Application Publication No. US 2011/0232020 to Rogers et al., published September 29, 2011, the disclosure of each of which is hereby incorporated herein in its entirety by this reference. 10 DISCLOSURE Described are antimicrobial devices and related assemblies and methods for disinfecting at least a portion of a medical device, such as, one or more portions of a medical device for at least one of delivering fluid to and sampling fluid from a subject 15 (e.g., an intravenous (IV) device) and for coupling to the same or a different medical device (e.g., to a syringe in order to form an initial sterile seal about a lumen of the syringe). Disclosed is an antimicrobial device including a disinfecting portion comprising a chamber including an amount of antimicrobial substance and a coupling 20 portion configured to secure the antimicrobial device to at least a portion of a medical device. Also disclosed is a medical device assembly including an antimicrobial device and a syringe having a needle hub, wherein the coupling portion of the antimicrobial device is engaged with a connection portion of the syringe at the needle hub. 25 Further disclosed is a method of disinfecting a portion of a device with an antiseptic and/or disinfectant solution such as alcohol and/or ethanol. The method includes removing an antimicrobial device from a first device, cleaning a portion of a second device with an amount of antimicrobial substance contained in the antimicrobial device, and removing the antimicrobial device from the portion of the 30 second device. Yet further disclosed is a medical device assembly including an antimicrobial device and a syringe. The antimicrobial device includes a disinfecting portion WO 2014/077906 PCT/US2013/047159 -3 comprising a chamber including an amount of antimicrobial substance and an engagement feature for retaining a portion of a medical device to be disinfected. The disinfecting portion is positioned at a first end portion of the antimicrobial device. The antimicrobial device further includes a coupling portion comprising a female 5 Luer connection for coupling with at least a portion of a male Luer connection of a medical device. The coupling portion is positioned at a second end portion of the antimicrobial device opposing the first end portion. The syringe includes a needle hub and the coupling portion of the antimicrobial device is engaged with and forms an initial sterilized seal with a male Luer connection of the syringe at the needle hub. 10 Yet further disclosed are methods of forming and using such antimicrobial devices. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 illustrates a perspective view of an antimicrobial device in accordance 15 with an embodiment of the disclosure. FIG. 2 illustrates a cross-sectional side view of the antimicrobial device shown in FIG. 1. FIG. 3 illustrates another cross-sectional side view of the antimicrobial device shown in FIG. 1 including a volume of antiseptic material within the antimicrobial 20 device. FIG. 4 illustrates a cross-sectional side view of an antimicrobial device in accordance with another embodiment of the disclosure. FIG. 5 illustrates a cross-sectional side view of a medical device assembly including an antimicrobial device coupled to a portion of a medical device in 25 accordance with yet another embodiment of the disclosure. FIG. 6 illustrates an enlarged portion of the medical device assembly shown in FIG. 5. FIGS. 7 through 10 illustrate cross-sectional side views of various configurations disinfecting portions of antimicrobial devices in accordance with 30 additional embodiments of the disclosure.
WO 2014/077906 PCT/US2013/047159 -4 FIG. 11 illustrates a cross-sectional side view of an antimicrobial device such as, for example, the antimicrobial device shown in FIGS. 1 through 6 received on a portion of another medical device including a threaded portion. 5 MODE(S) FOR CARRYING OUT THE INVENTION In the following detailed description, reference is made to the accompanying drawings that depict, by way of illustration, specific embodiments in which the disclosure may be practiced. However, other embodiments may be utilized, and structural, logical, and configurational changes may be made without departing from 10 the scope of the disclosure. The illustrations presented herein are not meant to be actual views of any particular material, apparatus, assembly, system, or method, but are merely idealized representations that are employed to describe embodiments of the disclosure. The drawings presented herein are not necessarily drawn to scale. Additionally, elements common between drawings may retain the same numerical 15 designation. Generally, antimicrobial devices as described herein may be utilized to disinfect potentially contaminated surfaces of various devices (e.g., medical devices). Related assemblies and methods are also disclosed herein. Such antimicrobial devices may be configured to include a first portion having a volume of antimicrobial 20 substance therein. For example, the volume of antimicrobial substance may comprise a disinfectant and/or antiseptic (e.g., a disinfectant and/or antiseptic in a fluid state) such as, for example, alcohol (e.g., isopropyl alcohol) at various concentrations (e.g., 50 to 90%), ethanol at various concentrations (e.g., ranging from 50 to 95%), and combinations of these and any other suitable disinfectant and/or antiseptics. The first 25 portion of the device may used to protect (e.g., by covering a portion of the medical device) and/or disinfect a portion of medical device by receiving the portion of the medical device (e.g., at least temporarily) within the cap. In some embodiments, such antimicrobial devices reduce the likelihood of microorganisms entering the bloodstream of a subject via a medical device or 30 assembly configured to deliver fluid to a subject and/or remove a fluid from a subject. For example, the antimicrobial device may be utilized with one or more portions of fluid flow or fluid delivery systems such as, for example, an intravenous (IV) device WO 2014/077906 PCT/US2013/047159 -5 that delivers substances (e.g., fluid) to and from one or more veins of a subject. Such IV devices may include a peripheral IV line having a cannula in communication with the vasculature of a subject. The IV device may include one or more connections, valves, and access ports for delivering fluids to and from the subject that may become 5 contaminated while the IV device is connected to the subject (e.g., in fluid communication with one or more portion of subject's internal systems). For example, the peripheral IV line may include one or more of needle injection sites (e.g., y-sites), needleless injection sites (e.g., a luer-activated valve (LAV)), and other fluid transfer devices. Accordingly, Antimicrobial devices as disclosed herein may be utilized with 10 any such connectors, valves, and access ports in such fluid flow or fluid delivery systems. In addition to the first portion (e.g., a first end) of the antimicrobial device for disinfecting and/or protecting portions of the medical device that are exposed to potential contamination during use (e.g., during use with a subject), the antimicrobial 15 devices disclosed herein also include a second portion (e.g., a second end) for coupling to a medical device (e.g., the same medical device to be disinfected or a different medical device). For example, the first, disinfecting end of the antimicrobial device may be utilized to disinfect portions of the medical device that are exposed to potential contamination during use. In some embodiments, the first, disinfecting end 20 of the antimicrobial device may also be at least temporarily (e.g., transiently, for a selected period a time) connected to (e.g., coupling and retaining) one or more portions of a medical device, such as, the various portions of fluid systems discussed above in order to disinfect and/or protect portions of the medical device that are exposed to potential contamination during use (e.g., during use with a subject). The 25 antimicrobial device may disinfect and protect a portion of the medical device from further contamination as the antimicrobial device remains secured to the medical device in disinfecting contact with the portion of the medical device. The second, coupling end of the antimicrobial device may include a coupling device (e.g., threads, such as a Luer connection) for coupling to the same medical 30 device to be disinfected or a different medical device. By way of example, many medical devices (e.g., a syringe) include a cover (e.g., a cap) that is positioned over an open end or lumen of the medical device and coupled to an engagement feature (e.g., WO 2014/077906 PCT/US2013/047159 -6 a threaded Luer connector) of the medical device in order to seal the medical device (e.g., from contamination) prior to use of the medical device. The coupling end of the antimicrobial device disclosed herein may perform the same or a similar function by sealing a portion of a medical device (e.g., before use). However, unlike typical 5 sealing caps, the antimicrobial device may further provide a disinfecting portion for use in disinfecting a portion of the same medical device to which the coupling end is attached or disinfecting another medical device entirely. As discussed below in greater detail, in some embodiments, the first, disinfecting end of such antimicrobial devices is configured to connect and secure to a 10 portion of a medical including threaded connection (e.g., threads of a Luer connection). In other embodiments, the first, disinfecting end of such antimicrobial devices is configured to connect and secure to both a portion of a medical device lacking a threaded connection and/or a portion of a medical including threaded connection (e.g., threads of a Luer connection). In other words, the antimicrobial 15 device may be configured to connect and secure to a portion of medical device with or without a threaded connection. For example, the antimicrobial device includes a flexible member (e.g., a membrane) configured to engage with a non-threaded portion (e.g., a portion having a smooth surface, a flat surface, an uneven non-threaded surface, or combinations thereof) of an access port of a medical device (e.g., a needle 20 injection site of an IV device). The flexible membrane of the antimicrobial device may also engage with a portion of a threaded portion (e.g., threads of Luer connection) of an access port of a medical device (e.g., a needleless injection site of an IV device). In other words, the flexible member alone may engage and secure the threaded portion (e.g., the threads) of the medical device to retain the portion of the 25 medical device within a housing of the antimicrobial device without the need for a set of complementary threads formed on the housing of the antimicrobial device. The flexible member or membrane of the antimicrobial device may be flexible in the sense that the membrane is easily deformable by a medical practitioner as the practitioner installs and removes the antimicrobial device from the portion of the medical by hand. 30 The stiffness of the flexible member may be selected based on the configuration of the flexible member of the antimicrobial device.
WO 2014/077906 PCT/US2013/047159 -7 FIG. 1 illustrates a perspective view of an antimicrobial device 100. As shown in FIG. 1, the antimicrobial device 100 includes a housing 102 and a sealing member 104. The sealing member 104 may comprise any suitable nonporous material configured to at least partially seal a volume of fluid within the housing 102 5 of the antimicrobial device 100. For example, the sealing member 104 may include pull-tab (e.g., a metal tab formed from a foil, polymer tab, etc.) having a first portion sealed about the housing 102 and a second portion for a practitioner to grab in order to remove the sealing member 104. It is noted that while the embodiment of FIG. 1 illustrates pull-tab type sealing member 104 on one end of the antimicrobial 10 device 100, in other embodiments, the sealing member covers all of the antimicrobial device 100 and a portion of the medical device to which it is coupled to seal the antimicrobial device 100 to the medical device (e.g., a shrink wrap covering the antimicrobial device 100 and the coupling between the antimicrobial device 100 and the medical device). 15 As depicted, the antimicrobial device 100 includes a disinfecting portion (e.g., disinfecting end 106) for disinfecting at least a portion of a medical device, which is sealed by the sealing member 104, and a coupling portion (e.g., coupling end 108) for coupling to a portion of a medical device (e.g., to a connection portion of the medical device). In other words, in this embodiment, the antimicrobial device 100 includes 20 the disinfecting end 106 and the coupling end 108 positioned on opposing ends of the housing 102 of the antimicrobial device 100. In other embodiments, the disinfecting portion and the coupling portion of the antimicrobial device is positioned at any suitable location on the housing of the antimicrobial device. The coupling end 108 of the antimicrobial device 100 includes a connection 25 portion 110 (e.g., threads 112 forming a threaded connection portion such as a female Luer connection). In some embodiments, the coupling end 108 includes an opening 114 and a chamber 115 (FIG. 2) for receiving a portion of a medical device (e.g., at least a portion of a male Luer connection). FIGS. 2 and 3 illustrate cross-sectional side views of the antimicrobial 30 device 100, where, for clarity, FIG. 2 shows the antimicrobial device 100 without a volume of antimicrobial substance positioned in the antimicrobial device 100 and WO 2014/077906 PCT/US2013/047159 -8 FIG. 3 shows the antimicrobial device 100 with the volume of antimicrobial substance 124 positioned in the antimicrobial device 100. As shown in FIG. 2, the disinfecting end 106 includes an opening 116 and a chamber 118 for receiving a portion of the medical device to be disinfected. As 5 depicted, the inner surface 120 of the portion of the housing 102 of the antimicrobial device 100 includes an engagement feature (e.g., threads 122 of a Luer connection) for engaging a portion of a medical device. For example, a complementary portion of a medical device (e.g., threads complementary to threads 122) may be inserted into chamber 118 to be disinfected. The threads 122 of the disinfecting end 106 may 10 retain (e.g., secure) the portion of the medical device within the chamber 118 until the portion of the medical device is removed (e.g., by unthreading). As shown in FIG. 3, the antimicrobial device 100 includes a volume of antimicrobial substance 124 within the housing 102, which may be initially sealed in the housing 102 with the sealing member 104 (FIG. 1). As discussed above, the 15 antimicrobial substance 124 may comprise at least one of a disinfectant and antiseptic in a fluid state at various concentrations. The volume of antimicrobial substance 124 will typically include a pad (e.g., sponge material, such as an open-cell foam, felt, fiber matrix, combinations thereof, etc.) configured to retain the antimicrobial substance within the housing 102. The pad of the volume of antimicrobial 20 substance 124 may be at least partially compressible such that the volume of antimicrobial substance 124 may fit within the housing 102 and may at least partially surround a portion of a medical device when the portion of the medical device is received within the housing 102. As further depicted in FIG. 3, in some embodiments, the chamber 115 of the 25 coupling end 108 may be empty. For example, the chamber 115 comprises a sterile volume (e.g., substantially devoid of any other elements or potential contaminates, apart from the atmosphere in which the chamber 115 is placed or, in some embodiments, the chamber 155 may comprise a vacuum). The sterile volume of the chamber 15 may be configured to receive and seal with a connection portion of a 30 medical device (see, e.g., FIGS. 5 and 6) to provide a sterile interface between the connection portion 110 of the antimicrobial device 100 and a connection portion of a medical device. For example, the antimicrobial device 100 may function as a WO 2014/077906 PCT/US2013/047159 -9 protective cap and be connected to the medical device during manufacture and/or packaging of the medical device to provide an initial sterilized seal about an open end of the medical device (e.g., an open end or lumen through which fluids are delivered to a subject). 5 FIG. 4 illustrates a cross-sectional side view of an antimicrobial device 200 that may be somewhat similar to and may include one or more features of the antimicrobial device 100 discussed above with regard to FIGS. 1 through 3. For example, the antimicrobial device 200 may include a disinfecting end 206 that is the same or substantially similar to the disinfecting end 106 of the antimicrobial 10 device 100. The antimicrobial device 200 may also include a coupling end 208 having a connection portion 210. However, the connection portion 210 may be formed as a male Luer connection similar to the configuration of the disinfecting end 206. The connection portion 210 includes an opening 214 and chamber 215 for receiving a portion of a medical device (e.g., a portion of a female Luer connection). 15 FIG. 5 illustrates a cross-sectional side view of a medical device assembly 300 including an antimicrobial device (e.g., antimicrobial device 100) coupled to a portion of a medical device (e.g., syringe 302) and FIG. 6 illustrates an enlarged portion of the medical device assembly 300 shown in FIG. 5. As shown in FIGS. 5 and 6, the connection portion 110 (formed as a female Luer connection) of the coupling end 108 20 of the antimicrobial device 100 is engaged with a complementary connection portion 304 (e.g., a male Luer connection) of the syringe 302. The coupling end 108 of the antimicrobial device 100 may act to seal (e.g., to maintain sterility) an opening 306 (e.g., lumen) of the syringe 302 at the needle hub 308. For example, the coupling end 108 of the antimicrobial device 100 may be used to form an initial seal 25 (e.g., prior to use of the syringe 302) that at least substantially prevents contaminants from entering the syringe 302 (e.g., entering the opening 306 and at the needle hub 308 and/or the chamber 310 within the barrel 312 of the syringe 302). In some embodiments, the medical device assembly 300 may include an additional sealing layer (e.g., shrink wrap) positioned over the interface between the antimicrobial 30 device 100 and the syringe 302. The antimicrobial device 100 may be removed from the syringe 302, thereby enabling the syringe 302 to be utilized separate from the antimicrobial device 100.
WO 2014/077906 PCT/US2013/047159 - 10 Similarly, the antimicrobial device 100 may be utilized separate from the syringe 302 to disinfect a portion of a medical device. For example, the antimicrobial device 100 may be utilized to disinfect a needleless injection site before fluid is introduced into an IV device to which the needleless injection site is connected with the syringe 302. 5 In some embodiments, the antimicrobial device 100 may also be reattached to the connection portion of the syringe 302 after being removed for an initial use of the syringe if necessary or desirable. FIGS. 7 through 10 illustrate cross-sectional side views of various configurations disinfecting portions of antimicrobial devices. For clarity, only the 10 disinfecting portions 406, 506, 606, 706 of the antimicrobial devices 400, 500, 600, 700 are shown in FIGS. 7 through 10. Nonetheless, each of antimicrobial devices 400, 500, 600, 700 includes a connection portion for coupling to a portion of a medical device that may, in some embodiments, be similar or the same as at least one of the connection portion 110 shown and described with reference to FIGS. 1 through 15 3 and the connection portion 210 shown and described with reference to FIG. 4. In other words, in some embodiments, each of antimicrobial devices 400, 500, 600, 700 includes a connection portion that comprises a male Luer connection or a female Luer connection. As shown in FIG. 7, antimicrobial device 400 includes a disinfecting end 406 20 having a volume of antimicrobial substance 424 initially sealed (e.g., by sealing member 404) within the housing 402. The disinfecting end 406 includes an engagement feature configured as a membrane 408. For example, the disinfecting end 406 may be similar or the same as the antimicrobial devices disclosed in United States Provisional Patent Application Serial No. 61/663,287 to Faulkner et al., filed 25 June 22, 2012, the disclosure of which is hereby incorporated herein in its entirety by this reference. As disclosed in Provisional Patent Application Serial No. 61/663,287, the membrane 408 (e.g., a flexible membrane) includes an opening 409 for receiving a portion of a medical device. The membrane 408 is configured to at least partially yield (e.g., elastically yield) about the portion of the medical device when inserted 30 within the housing 402 to disinfect and at least temporarily retain the portion of the medical device within the housing 402.
WO 2014/077906 PCT/US2013/047159 - 11 As shown in FIG. 8, antimicrobial device 500 includes a disinfecting end 506 having a volume of antimicrobial substance 524 initially sealed (e.g., by sealing member 504) within the housing 502. Similar to antimicrobial device 400 (FIG. 7), the disinfecting end 506 of antimicrobial device 500 also includes an engagement 5 feature configured as a membrane 508. However, membrane 508 includes a throat portion 510. As also disclosed in Provisional Patent Application Serial No. 61/663,287, the membrane 508 (e.g., a flexible membrane) includes the throat portion 510 extending into the housing 502 and an opening 509 formed by throat portion 510 for receiving a portion of a medical device. The membrane 508 is 10 configured to at least partially yield (e.g., elastically yield) about the portion of the medical device when inserted within the housing 502 to disinfect and at least temporarily retain the portion of the medical device within the housing 502. The throat portion 510 may be formed to have a substantially cylindrical shape (e.g., a cylinder being coaxial with the housing 502) and may extend from a portion of the 15 membrane 508 into the housing 502 (e.g., toward the volume of antimicrobial substance 524 within the housing 502). The throat portion 510 may extend around a portion of the medical device received within the housing 502 and act to enhance the coupling (and retaining) of the portion of the medical device in the housing 502 by the membrane 508. 20 As shown in FIG. 9, antimicrobial device 600 includes a disinfecting end 606 having a volume of antimicrobial substance 624 initially sealed (e.g., by sealing member 604) within the housing 602. Similar to antimicrobial devices 400, 500 (FIGS. 7 and 8), the disinfecting end 606 of antimicrobial device 600 includes an engagement feature configured as a membrane 608. However, membrane 608 25 includes a throat portion 610 having threads 612. For example, the disinfecting end 606 may be similar or the same as the antimicrobial devices disclosed in United States Provisional Patent Application Serial No. 61/663,272 to Faulkner et al., filed June 22, 2012, the disclosure of which is hereby incorporated herein in its entirety by this reference. As disclosed in Provisional Patent Application Serial No. 61/663,272, 30 the membrane 608 (e.g., a flexible membrane) includes the throat portion 610 extending into the housing 602 and an opening 609 formed by throat portion 610 for receiving a portion of a medical device. The membrane 608 is configured to at least WO 2014/077906 PCT/US2013/047159 - 12 partially yield (e.g., elastically yield) about the portion of the medical device when inserted within the housing 602 to disinfect and at least temporarily retain the portion of the medical device within the housing 602. The throat portion 610 may be formed to have a substantially cylindrical shape (e.g., a cylinder being coaxial with the 5 housing 602) and may extend from a portion of the membrane 608 into the housing 602 (e.g., toward the volume of antimicrobial substance 624 within the housing 602). The throat portion 610 may extend around a portion of the medical device received within the housing 502 and act to enhance the coupling (and retaining) of the portion of the medical device in the housing 602 by the 10 membrane 608. For example, the threads 612 (e.g., threads of Luer connector) extending from an inner surface of the throat portion 610 of the membrane 608 may be configured to receive and engage with a complementary threaded portion of a medical device. As shown in FIG. 10, antimicrobial device 700 includes a disinfecting end 706 15 having a volume of antimicrobial substance 724 initially sealed (e.g., by sealing member 704) within the housing 702. Similar to antimicrobial device 400 (FIG. 7), the disinfecting end 706 of antimicrobial device 700 includes an engagement feature configured as a membrane 708 with an opening 709 formed therein for receiving a portion of a medical device. However, membrane 708 includes a proximal end 710 20 that is oriented to angularly correspond with an end of a y-site medical device (e.g., an end of a y-site medical device including a needle access valve). As also disclosed in Provisional Patent Application Serial No. 61/663,287, the housing 702 may have a proximal end 710 that is angularly offset from the housing 702. For example, the membrane 708 and proximal end 710 of the housing 702 are positioned at an oblique 25 angle relative to a longitudinal axis 712 of the housing 702. In other words, the membrane 708 and proximal end 710 of the housing 702 extend in a plane that is not perpendicular to (e.g., does not form a right angle with) the longitudinal axis 712 of the housing 702. In some embodiments, the housing 702 may have a substantially trapezoidal shape (e.g., a right trapezoidal shape). 30 The membranes 408, 508, 608, 708 may enable the antimicrobial devices 400, 500, 600, 700 to be retained on a non-threaded portion of a medical device such as, WO 2014/077906 PCT/US2013/047159 - 13 for example, a needle access site, a threaded portion of a medical device such as, for example, a needleless access site, or combinations thereof. Although the connection portions of the antimicrobial devices discussed herein have been shown as threaded connections (e.g., male or female Luer 5 connections), in other embodiments, the connection portions of the coupling portions of the antimicrobial devices may include any of the membranes 408, 508, 608, 708 discussed above with reference to FIGS. 7 through 10 to couple to a portion of a medical device (e.g., to form an initial sterile seal with the portion of the medical device). 10 FIG. 11 illustrates a cross-sectional side view of an antimicrobial device such as, for example, the antimicrobial device 100 shown in FIGS. 1 through 6 received on a threaded portion 22 of a medical device 20. As shown in FIG. 11, the threaded portion 22 of the medical device 20 (e.g., a threaded Luer connection of a needleless access site) may be inserted into the disinfecting end 106 of the antimicrobial 15 device 100 through the opening 116 and into the chamber 118. In some embodiments, the threads 122 formed in the chamber 118 of the antimicrobial device 100 may engage with complementary threads 24 on the threaded portion 22 of the medical device 20 to secure the threaded portion 22 of the medical device 20 within the disinfecting end 106 of the antimicrobial device 100. In other 20 embodiments, the disinfecting end 106 may include a different engagement feature (e.g., a membrane as shown in FIGS. 7 through 10) for engaging a portion of the medical device 20 (e.g., the threaded portion 22). The portion of the medical device 20 may be inserted into the disinfecting end 106 of the antimicrobial device 100 in order to at least partially disinfect the 25 portion of the medical device 20 with the volume of antimicrobial substance 124. For example, the disinfecting end 106 of the antimicrobial device 100 is configured to position a portion of the medical device 20 to be disinfected proximate (e.g., in contact with) the antimicrobial substance 124 within the disinfecting end 106. In some embodiments, the portion of the medical device 20 may at least partially deform 30 the volume of antimicrobial substance 124 (e.g., the pad holding the volume of antimicrobial substance 124).
WO 2014/077906 PCT/US2013/047159 - 14 Referring to FIGS. 5 and 11, in use, a portion of an antimicrobial device (e.g., the coupling end 108 of the antimicrobial device 100) may be used to form a seal on a medical device, such as, for example, a syringe 302 (e.g., an initial sterilized seal provided after manufacture and/or assembly of a medical device and before a first 5 instance of use of the medical device). The coupling end 108 of the antimicrobial device 100 may be removed from the syringe 302 to enable the syringe 302 to be utilized in a medical procedure. The sealing member 104 of the antimicrobial device 100 may be removed to provide access to the volume of antimicrobial substance 124 within the disinfecting end 106 of the antimicrobial device 100. A 10 portion of a medical device (e.g., another medical device 20) may be inserted into the disinfecting end 106 of the antimicrobial device 100 to at least partially disinfect the portion of the medical device 20 with the volume of antimicrobial substance 124. In some embodiments, antimicrobial devices may be formed with one or more suitable materials such as, for example, metals, alloys, polymers, ceramics, 15 combinations thereof, etc. Membranes of the antimicrobial devices, where implemented, may be formed from a flexible material such a silicon or a polymer. The housing of the antimicrobial device may be formed from a polymer such as, for example, a polyethylene, polyvinylchloride, or other high-density polymers. Once being apprised of the instant antimicrobial devices, one of ordinary skill 20 in the art will be readily able to make (e.g., by injection molding) and assemble the device.

Claims (12)

  1. 2. The antimicrobial device of claim 1, wherein the disinfecting portion comprises a first end of the antimicrobial device and the coupling portion comprises a 15 second end of the antimicrobial device.
  2. 3. The antimicrobial device of claim 2, wherein the first end opposes the second end. 20 4. The antimicrobial device of any one of claims 1 through 3, wherein the second chamber is entirely free of any antimicrobial substance.
  3. 5. The antimicrobial device of any one of claims 1 through 4, wherein the coupling portion comprises a female Luer connection for coupling with at least a 25 portion of a male Luer connection of the medical device.
  4. 6. The antimicrobial device of claim 5, wherein the female Luer connection of the coupling portion is configured to couple with and form an initial sterilized seal with a male Luer connection of a syringe. 30 WO 2014/077906 PCT/US2013/047159 - 16 7. The antimicrobial device of any one of claims 1 through 6, wherein the disinfecting portion comprises an engagement feature for retaining a portion of a medical device. 5 8. The antimicrobial device of claim 7, wherein the engagement feature comprises at least one of a threaded Luer connection and a membrane having an opening therein.
  5. 9. The antimicrobial device of claim 7, wherein the engagement feature is 10 configured to angularly correspond and engage with an end of a y-site medical device proximate a needle access valve.
  6. 10. The antimicrobial device of any one of claims 1 through 9, wherein the disinfecting portion is configured to engage with a portion of a first medical device 15 and wherein the coupling portion is configured to engage with a portion of a second medical device distinct from the first medical device.
  7. 11. The antimicrobial device of claim 10, wherein the first medical device comprises a needleless injection site and the second medical device comprises a 20 syringe.
  8. 12. A medical device assembly comprising: the antimicrobial device of claim 1; and a syringe having a needle hub, wherein the coupling portion of the antimicrobial 25 device is engaged with a connection portion of the syringe at the needle hub.
  9. 13. The medical device assembly of claim 12, wherein the connection portion of the syringe comprises a male Luer connection and wherein the coupling portion of the antimicrobial device comprises a female Luer connection coupled with 30 the male Luer connection of the syringe. WO 2014/077906 PCT/US2013/047159 - 17 14. The medical device assembly of claim 12 or 13, wherein the coupling portion of the antimicrobial device forms an initial sterile seal about a lumen of the syringe. 5 15. A medical device assembly comprising: an antimicrobial device comprising: a disinfecting portion comprising a chamber including an amount of antimicrobial substance and an engagement feature for retaining a portion of a medical device to be disinfected, the engagement feature 10 comprising a male Luer connection for coupling with a female Luer connection of a medical device to be disinfected, wherein the disinfecting portion is positioned at a first end portion of the antimicrobial device; and a coupling portion comprising a female Luer connection for coupling with at 15 least a portion of a male Luer connection of a medical device, the coupling portion positioned at a second end portion of the antimicrobial device opposing the first end portion; and a syringe having a needle hub, wherein the coupling portion of the antimicrobial device is engaged with and forms an initial sterilized seal with a male Luer 20 connection of the syringe at the needle hub.
  10. 16. A medical device assembly comprising: an antimicrobial device comprising: a disinfecting portion comprising a chamber including an amount of 25 antimicrobial substance and an engagement feature for retaining a portion of a medical device to be disinfected, the engagement feature configured to angularly correspond and engage with an end of a y-site medical device proximate a needle access valve, wherein the disinfecting portion is positioned at a first end portion of the 30 antimicrobial device; and WO 2014/077906 PCT/US2013/047159 - 18 a coupling portion comprising a female Luer connection for coupling with at least a portion of a male Luer connection of a medical device, the coupling portion positioned at a second end portion of the antimicrobial device opposing the first end portion; and 5 a syringe having a needle hub, wherein the coupling portion of the antimicrobial device is engaged with and forms an initial sterilized seal with a male Luer connection of the syringe at the needle hub.
  11. 17. A method of disinfecting a portion of a device, the method comprising: 10 removing an antimicrobial device from a first device; cleaning a portion of a second device with an amount of antimicrobial substance contained in the antimicrobial device; and removing the antimicrobial device from the portion of the second device. 15 18. The method according to claim 17, wherein removing an antimicrobial device from a first device comprises decoupling a portion of the antimicrobial device covering a lumen of a syringe from the syringe.
  12. 19. The method according to claim 17 or 18, further comprising coupling 20 the antimicrobial device to the portion of the second device.
AU2013345415A 2012-11-19 2013-06-21 Antimicrobial devices for use with medical devices, medical device assemblies and related methods Abandoned AU2013345415A1 (en)

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AU2017208921B2 (en) 2016-01-18 2021-12-16 Becton, Dickinson And Company Disinfection cap for IV needleless connectors
CN109045396A (en) * 2018-07-31 2018-12-21 杨福荣 A kind of retention needle infusion connector with chlorination equipment

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US8197749B2 (en) * 2007-01-16 2012-06-12 The University Of Utah Research Foundation Methods for cleaning luer connectors
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US20090137969A1 (en) * 2007-11-26 2009-05-28 Colantonio Anthony J Apparatus and method for sterilizing a tubular medical line port
CN102548587A (en) * 2009-06-01 2012-07-04 艾维拉医疗公司 Medical implement cleaning device with friction-based fitting
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