EP3057635B1 - Dispositifs de transfert de fluide et leurs systèmes et procédés d'utilisation pour distribuer des fluides médicaux - Google Patents

Dispositifs de transfert de fluide et leurs systèmes et procédés d'utilisation pour distribuer des fluides médicaux Download PDF

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Publication number
EP3057635B1
EP3057635B1 EP14853288.0A EP14853288A EP3057635B1 EP 3057635 B1 EP3057635 B1 EP 3057635B1 EP 14853288 A EP14853288 A EP 14853288A EP 3057635 B1 EP3057635 B1 EP 3057635B1
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EP
European Patent Office
Prior art keywords
outer shell
fluid
fluid flow
inner housing
flow path
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Application number
EP14853288.0A
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German (de)
English (en)
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EP3057635A4 (fr
EP3057635A1 (fr
Inventor
David K. Stroup
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Infusion Innovations Inc
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Infusion Innovations Inc
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2044—Separating means having slits
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2051—Connecting means having tap means, e.g. tap means activated by sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2055—Connecting means having gripping means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048—Connecting means
    • A61J1/2058—Connecting means having multiple connecting ports
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079—Filtering means
    • A61J1/2082—Filtering means for gas filtration

Definitions

  • Injection safety refers to the proper use and handling of supplies for administering injections and infusions (e.g., syringes, needles, intravenous tubing, medication vials, and parenteral solutions). These practices are intended to prevent transmission of materials between one patient and another, or between a patient and healthcare personnel during preparation and administration of parenteral medications. Safe injection practices are vitally important in infection control in the medical setting.
  • supplies for administering injections and infusions e.g., syringes, needles, intravenous tubing, medication vials, and parenteral solutions.
  • Parenteral medications are typically packaged in containers such as vials, ampoules, and flexible bags, from which the medication is administered via a transfer device.
  • the transfer device typically comprises a first section which is designed to pierce a septum or other seal on the medication container, thereby permitting access to the contents, and a second section for sealingly and releasably mating with a fluid delivery device such as a syringe or infusion tubing.
  • US2012/0157914 describes an apparatus and method for controlling flow through a fluid line or device for, inter alia, delivering fluid via an intravenous or other medical fluid line into a patient, a syringe, container, and/or other medical device, and systems including such connectors and/or valves.
  • a valve assembly which may be coupled to a container defines a fluid path from the container when the valve assembly is in an open condition, and prevents flow of fluid from the container when the valve assembly is in a closed condition.
  • An inner housing if the valve assembly is movable relative to its outer housing, and a rotational force moves a sealing pin within the inner housing between a first, closed position and a second, open position.
  • This system provides a sequential locking mechanism which cab mechanically prevent accidental discharge of a medication, and provide a visual indicator confirming the status (open or closed) of the connection between the container, transfer device, and fluid delivery device.
  • a self-sealing male Luer connector is known which attaches to any standard female Luer valve to open a flow channel between the two.
  • the self-sealing male Luer connector includes a rigid housing having a distal end with a rigid male Luer connector and a proximal end at which a proximal seal is formed.
  • the distal end of the housing includes a valve seat.
  • a resilient biasing member that biases an actuator into contact with the valve seat to prevent fluid flow through the male connector.
  • the actuator Upon engagement with a female connector, the actuator is moved in the proximal direction to open the distal valve and then the proximal seal.
  • a partial vacuum is formed within the male connector upon disengagement with the female connector that draws any fluids on the external surface of the distal end of the male Luer connector into the male tip.
  • US patent application US 2003/153895 A1 discloses a vial adapter having a needle-free valve, a sharpened cannula used to perforate a vial's rubber stopper, and a circular array of claws of different lengths to engage vial closures of different diameters.
  • the array of claws includes a first set of claws each having a first length extending inwardly from the periphery of the housing of the adapter and a second set of claws alternating with the first set of claws and each having a longer length.
  • the second set of claws are mounted so that they deflect and plastically deform out of the way in the case where the adapter is engaged with a vial that exceeds a predetermined size.
  • the housing includes a shroud that is at least as long as the sharpened cannula to protect medical personnel who use the adapter from inadvertent punctures.
  • the needle-free valve includes a resiliently deformable piston element with a naturally open bore. The interior of the piston provides a fluid flow path through the adapter.
  • IV intravenous
  • the invention provides a device for controlling fluid flow, referred to herein as a fluid transfer device, comprising:
  • the fluid transfer device may be provided as a standalone element for mating with a corresponding valve actuating device which is configured to control the pressure-actuated opening.
  • the valve actuating device comprises:
  • the fluid transfer device and the valve actuating device are provided and/or used together as a system for controlling fluid flow. These may be provided in a single package, or in separate packaging.
  • the packaging is configured to enclose, and to provide a sterile internal environment for, the fluid transfer device and/or the valve actuating device.
  • the distal and/or proximal ends of the fluid transfer device and/or the valve actuating device may be provided with a removable seal in order to inhibit microbial contamination prior to use of the device(s). Such seals are intended to be peeled from the end of the device by the end user at the time of use.
  • the first outer shell comprises a spike member at the proximal end thereof.
  • This spike member may take the form of an IV bag spike or a piercing member for piercing the septum on a medication vial for example.
  • the purpose of this spike member is to fluidly connect the interior of the medical container to the first flow path, so that the fluid transfer device may operate to pass fluid when actuated.
  • the first outer shell may also comprise a filter element fluidly connected to a vent aperture configured to provide pressure equalization between the first fluid flow path and atmospheric pressure. This can facilitate volume removal from the medication container without creating a pressure differential within the container, and can reduce spray of toxic chemicals from inside the medication container during use.
  • the spike member may be configured as a "dual channel" member, with one channel providing fluid transfer, and the other channel providing pressure equalization. Examples of such filters are disclosed in U.S. Patent 7,326,194 .
  • movement of the inner housing from its first position to its second position causes a status indicator comprising a colored outer surface portion of the inner housing to extend from the second outer shell, wherein extension of the status indicator indicates fluid connection of the first and second fluid flow paths.
  • the distal end of the second outer shell can comprise a set of connector threads surrounding a boss on one end and a passage through the boss to an outlet end opening.
  • This can take the form of, for example, a male or female luer fitting to facilitate attachment of a corresponding piece of medical equipment such as a syringe, flow line (cannula, catheter, etc.).
  • the connector threads take the form of a female Luer-Lock® (Becton Dickinson) fitting having a hub configured to screw into threads in a sleeve on a luer male fitting.
  • the devices and systems disclosed herein may be used in methods for the control and/or administration of fluids. Such methods comprise:
  • these methods may further comprise rotating the second outer shell relative to the inner housing such that the inner housing is moved from its second position to its first position, thereby causing the resilient body to close the pressure actuated opening; and removing the first outer shell from the second outer shell by rotating the first outer shell relative to the second outer shell to disengage the first and second engagement structures.
  • proximal refers to a first end of the device and “distal” refers to a second opposite end of the device.
  • Actuated refers to the condition in which the fluid path is opened to allow fluid to transfer freely along the fluid path
  • deactuated refers to the condition in which the fluid path is closed and fluid transfer is not permitted
  • “Engaged” or “mated” refers to the condition in which two members that are designed for connection, for example, Luer connectors, are physically connected to each other in a manner in which they are designed to be connected, while “disengaged” refers to the condition in which two members, for example, Luer connectors, are physically disconnected from one another.
  • engaged When two members are referred to as “engaged,” they may or may not be “actuated.” The two members are “actuated” only when they are fully engaged, and fluid transfer is permitted between them.
  • Fig. 1 depicts an exemplary embodiment of a fluid transfer device, generally designated 100 , constructed and operative in accordance with the teachings of the present invention for enabling control of fluid flow from a medicinal vessel 200.
  • the fluid transfer device 100 includes an elongated outer shell base member 102 which is covered at its distal end by a removable protective cover 101.
  • the fluid transfer device typically include a lumen defining a flow path defined by a proximal end and a distal end connected by a lumen, and a flow control member for controlling flow from the proximal to distal end.
  • the lower skirt of fluid transfer device 100 may be configured to snap fit over the top flange of a standard medical vial.
  • fluid transfer device 100 includes a lumen having an engagement structure 103.
  • the lumen is configured as a female bore to receive a valve actuating device 300 (shown in Fig. 5 ) inserted thereinto.
  • valve actuating device 300 shown in Fig. 5
  • this configuration could be modified by, for example, configuring fluid transfer device 100 as a male boss which fits into a female bore of a valve actuating device 300.
  • a "key" engagement structure 301 on the valve actuating device 300 is designed to fit into engagement structure 103 by insertion and rotation about the central axis of the lumen, thereby locking the valve actuating device into the lumen and preventing its removal until the lock is disengaged by counter-rotation about the central axis.
  • This lock-and-key structure of the engagement structure 103 with its counterpart engagement structure 301 on the valve actuating device provides at least two benefits. First, it prevents accidental attachment of a non-corresponding fitting (e.g., a standard luer fitting would not engage the engagement structure 103. Second, it provides an anchor for the driving force necessary to move the pressure member of fluid transfer device 100 is movable relative to the first outer shell from a first position to a second position, thereby opening the pressure-actuated opening and permitting fluid flow.
  • Fig. 3 provides a cross-sectional view of fluid transfer device 100 in isolation from the medicinal vessel 200.
  • the flow path 103 through the device is provided through spike member 108 until it meets a seal in the form of a resiliently deformable body 104.
  • a pre-cut slit 105 provides a pressure actuated opening; application of pressure on the central portion of the resilient body 104 causes deformation, thereby opening slit 105. Upon release of this pressure, the resilient nature of resilient body 104 causes the slit to re-seal, thereby blocking fluid flow.
  • the resiliently deformable body 104 may be made from rubber materials such as natural rubbers, silicone rubbers chlorobutyl rubbers, and the like; elsatomeroc fluoropolymers such as Kel-F®, Viton®, Kalrez®, and the like, and may have a PTFE layer facing the flow path 103 to form a chemically resistant barrier between the sample and the main seal material.
  • Pressure is applied from above the resilient body 104 by movement of actuating plunger 106 downward from the position shown in Fig. 3 to a second position which drives into resilient body 104 and activates pressure actuated opening 105.
  • This movement is affected by valve actuating device 300 as described hereinafter.
  • This actuation of pressure actuated opening 105 provides the first of a redundant set of seals which prevents undesired access to the flow of materials through the flow system. In this example, a downward movement of approximately 1.8 mm is sufficient to activate the flow system at pressure actuated opening 105.
  • the fluid transfer device 100 may be enclosed for shipping and storage in an outer enclosure 109 with a bottom closure 107 that may be peeled open to allow the end user access to the fluid transfer device 100 for use.
  • This outer enclosure 109 may be sealed during manufacturing and the entire package subjected to sterilization to ensure a sterile final product.
  • Fig. 4 provides a cross-sectional view of fluid transfer device 100 in position on medicinal vessel 200.
  • spike 108 has punctured the septum 201 of medicinal vessel 200 to allow the flow path 103 access to the interior of the vial.
  • pressure actuated opening 105 is in its closed position, and top seal 101 has yet to be removed for use by the end user.
  • the lumen of fluid transfer device 100 is ready to accept valve actuating device 300.
  • "key" engagement structure 301 on the valve actuating device 300 is designed to fit into "lock” engagement structure 103 by insertion and rotation about the central axis of the lumen, thereby locking the valve actuating device into the lumen.
  • FIG. 6 A cross-sectional view of the mated devices is depicted in Fig. 6 .
  • the design of valve actuating device 300 is similar to that described in US2012/0157914 .
  • the outer shell 306 generally includes a proximal end, a distal end, and a passage 305 extending therebetween.
  • the inner housing 307 is slidably disposed within the outer shell 306.
  • the distal end of the inner housing 306 may include a connector including a set of connector threads 302 surrounding a boss, e.g., defining a first helical axis, for connecting the device to a fluid line.
  • the connector threads and boss are depicted as a male luer connector.
  • the connector may be replaced with alternative connector devices for connecting the system in a fluid line, or permanently connecting the valve to an outlet end of a needleless syringe for example.
  • a sealing pin 303 having a tapered end portion is disposed within a tapered or reduced diameter outlet opening of the boss. Sealing pin 303 seats on seal 304 in the closed position to provide the second of a redundant set of seals which prevents flow of materials through the system.
  • the sealing pin 303 may be formed from flexible material, e.g., silicone or other elastomeric material, for sealingly engaging seal 304 in the first position.
  • cam features may be provided on the inner housing 307 and the outer shell 306 for limiting movement of the inner housing helically within the outer shell between the first or closed position and the second or open position.
  • a set of camming threads on the inner housing 307 define a second helical axis opposite a first helical axis on the outer shell 306.
  • this movement of the inner housing 307 also provides the force necessary to move actuating plunger 106 downward to a second position which drives into actuating plunger 106 resilient body 104 and activates pressure actuated opening 105.
  • rotation of the inner housing 307 relative to the outer shell 306 opens both redundant seals within the system, permitting flow from the reagent vial, through fluid transfer device 100 , and ultimately to the outlet at the distal end of valve actuating device 300.
  • the inner housing may include one or more status indicators, e.g., that provide a visual indication when the fluid path is open.
  • a status indicator e.g., that provide a visual indication when the fluid path is open.
  • thermoplastics include PMMA, cyclic olefin copolymer, ethylene vinyl acetate, polyacrylate, polyaryletherketone, polybutadiene, polycarbonate, polyester, copolyesters, polyetherimide, polysulfone, nylon, polyethylene, and polystyrene.
  • thermosets include polyesters, polyurethanes, duroplast, epoxy resins, and polyimides. This list is not meant to be limiting.
  • Functional filler materials such as talc and carbon fibers can be included for purposes of improving stiffness, working temperatures, and part shrinkage.
  • Those portions of fluid transfer device 100 and valve actuating device 300 which contact fluid intended for patient administration are preferably biocompatible, or coated with a biocompatible material.
  • the FDA has adopted the ISO-10993 standard as its criteria for guiding the selection of biocompatibility testing for a given type of device, and ISO-10993 may therefore be used as a guide in the selection of materials for use in manufacturing various components of the devices described herein.
  • Many elastomers, such as PVC use plasticizers such as phthalate esters to increase flexibility and soften elastomers. Many of these plasticizers have been suggested to leach and provide health risks, and so are preferably avoided.
  • one or more components of fluid transfer device 100 and valve actuating device 300 may include one or more coatings or other materials, e.g., for reducing infection.
  • at least one of the inner housing and the shaft may include anti-adhesive material, e.g., a coating on surfaces of the inner housing and shaft exposed along the fluid path, such as a hydrophilic coating and a coating of anti-fibronectin antibodies.
  • At least one of the inner housing and shaft may include an antimicrobial agent, e.g., a coating on surfaces of the inner housing and shaft exposed along the fluid path, such as a coating including a silver ion, one or more therapeutic antibiotics, minocylcine, rifampin, and tetracycline, or one or more surfaces may be impregnated with exidine or silver sulfadiazine, ultra low fouling zwitterionic-based material, and the like.
  • an antimicrobial agent e.g., a coating on surfaces of the inner housing and shaft exposed along the fluid path, such as a coating including a silver ion, one or more therapeutic antibiotics, minocylcine, rifampin, and tetracycline, or one or more surfaces may be impregnated with exidine or silver sulfadiazine, ultra low fouling zwitterionic-based material, and the like.
  • FIG. 7 depicts a fluid transfer device 400 adapted to connect to a standard IV bag.
  • a spike member 401 enclosing a lumen 402 is depicted as a standard bag spike.
  • Lumen 402 is fluidly connected to fluid flow path 403 , which meets a seal in the form of a resiliently deformable body 404.
  • a pre-cut slit 405 provides a pressure actuated opening; application of pressure on the central portion of the resilient body 404 causes deformation, thereby opening slit 105.
  • resilient body 404 Upon release of this pressure, the resilient nature of resilient body 404 causes the slit to re-seal, thereby blocking fluid flow. Pressure is applied from above the resilient body 404 by movement of actuating plunger 406 downward from the position shown in Fig. 6 to a second position which drives into resilient body 404 and activates pressure actuated opening 405. This movement is affected by valve actuating device 300 as described above.
  • "key" engagement structure 301 on the valve actuating device 300 is designed to fit into "lock” engagement structure 408 by insertion and rotation about the central axis of the lumen, thereby locking the valve actuating device into the lumen.
  • a replaceable cap 407 is provided as a protective cover.
  • the handling devices for chemotherapeutic agents and other highly toxic drugs of the present invention preferably contain a filter or closed system to prevent aerosolization of the vial contents due to pressure changes within the vial during reconstitution and delivery.
  • Figs. 8-12 depicts a closed system comprising a flexible enclosure 500 which provides a reservoir of air which is sealed to fluid transfer device 100 such that any aerosol that exits the vial 200 is entrapped within the enclosure.
  • the flexible reservoir comprises a sealing ring 502 and a flexible pouch 501.
  • the surface of sealing ring 502 which contacts base member 102 comprises an adhesive surface layer comprising a backing sheet having a low-adhesion surface permitting it to be peeled away from the adhesive layer and discarded.
  • the closed system is assembled by inserting the vial into pouch 501 , exposing the adhesive layer and inserting pouch 501 into base member 102 as shown in Fig.
  • a backing sheet having a low-adhesion surface is peeled away from the upper surface of sealing ring 502 , exposing a second adhesive layer.
  • Engagement structure 103 is then mated with this adhesive layer as depicted in Fig. 11 .
  • a cap 110 is used to prevent the adhesive layers from releasing.
  • a syringe 600 mated to valve actuating device 300 may be used to withdraw contents from the vial as described above.
  • fluid transfer device 100 comprises a vent arm 111 which, when fluid transfer device 100 is mated to vial 200 , provides an opening by which changes in pressure may be equalized with the atmosphere. In this alternative configuration any aerosol that exits the vial 200 is entrapped. Vent arm 111 terminates in a connector such as a Luer taper fitting which permits the attachment of a physical capture device (e.g., syringe) 700 or a filter device 800 that prevent aerosolization of vial contents.
  • a physical capture device e.g., syringe
  • a change in pressure caused by depression of syringe 600 during filling the vial 200 for reconstitution of contents will result in an equal displacement of air into syringe 700 , thereby moving the plunger of syringe 700 outward.
  • a subsequent extraction of material from the vial into syringe 600 will move the plunger of syringe 700 inward.
  • the filter is selected such that air passes but not fluids. Suitable venting devices use a 0.22 micron hydrophobic filter for entrapment of aerosols.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Claims (10)

  1. Système pour contrôler l'écoulement d'un fluide, comprenant :
    (a) un dispositif de transfert de fluide (100) comprenant
    (i) une première enveloppe extérieure (102) ayant une extrémité proximale et une extrémité distale ;
    (ii) une ou plusieurs premières structures d'engagement (103) sur une surface de la première enveloppe extérieure (102) à son extrémité distale,
    (iii) un premier trajet d'écoulement de fluide (103) de l'extrémité proximale à l'extrémité distale,
    (iv) un élément d'étanchéité positionné à l'intérieur du premier trajet d'écoulement de fluide, l'élément d'étanchéité comprenant un corps élastique (104) et une ouverture actionnée par pression (105) dans le corps élastique (104) configuré pour contrôler de manière réversible l'écoulement à travers le premier trajet d'écoulement de fluide (103), et
    (v) un élément de pression engagé de manière mobile à l'intérieur de la première enveloppe extérieure (102) sur le côté distal de l'élément d'étanchéité de sorte que l'élément de pression est mobile par rapport à la première enveloppe extérieure (102) d'une première position à une seconde position, la première position étant configurée pour permettre au corps élastique (104) de fermer l'ouverture actionnée sous pression (105) et la seconde position configurée pour permettre un écoulement par le premier passage d'écoulement (103) du fluide en ouvrant l'ouverture (105) commandée sous pression ; et
    (b) un dispositif d'actionnement de soupape (300) comprenant
    (i) une seconde enveloppe extérieure (306) ayant une extrémité proximale et une extrémité distale,
    (ii) une ou plusieurs secondes structures d'engagement (301) sur une surface de la seconde enveloppe extérieure (306) à son extrémité proximale, dans lequel l'extrémité proximale de la seconde enveloppe extérieure (306) est configurée pour s'accoupler de manière réversible avec l'extrémité distale de la première enveloppe extérieure (102), et les première et seconde structures d'engagement (103, 301) sont configurées pour retenir la première enveloppe extérieure (102) sur la seconde enveloppe extérieure (306) en une configuration de verrouillage réversible par rotation de la première enveloppe extérieure (102) relativement à la seconde enveloppe extérieure (306),
    (iii) un second trajet d'écoulement de fluide de l'extrémité proximale à l'extrémité distale,
    (iv) un boîtier intérieur (307) engagé de manière mobile à l'intérieur de la seconde coque extérieure (306) de telle sorte que le boîtier intérieur (307) est mobile par rapport à la seconde coque extérieure (306) d'une première position à une seconde position par mouvement rotatif de la seconde coque extérieure (306) relativement au boîtier intérieur (307), le boîtier intérieur (307) comprenant un bossage central fournissant un trou traversant définissant au moins partiellement le second passage d'écoulement du fluide,
    (v) une tige d'étanchéité (303) couplée à la seconde enveloppe extérieure (306) et s'étendant dans l'alésage traversant du bossage central, la tige d'étanchéité (303) ayant une première extrémité qui est configurée pour un engagement étanche dans l'alésage traversant du bossage central pour empêcher un écoulement de fluide à travers la seconde voie d'écoulement du fluide dans la première position du boîtier intérieur (307), et qui est configurée pour permettre un écoulement par le second moyen de l'écoulement du fluide en séparant la tête centrale dans la seconde position du boîtier intérieur (307),
    dans laquelle, lorsque la première enveloppe extérieure (102) et la seconde enveloppe extérieure (306) sont engagées dans la configuration verrouillée de manière réversible, le déplacement du boîtier intérieur (307) de sa première position à sa seconde position applique une pression à l'élément de pression, déplaçant ainsi l'élément de pression de sa première position à sa seconde position pour relier de manière fluide les première et seconde voies de circulation de fluide.
  2. Système selon la revendication 1, dans lequel la première enveloppe extérieure (102) comprend un élément en pointe (108) à son extrémité proximale configuré pour s'insérer dans le septum (201) d'un récipient de médicament (200) et relier fluidiquement l'intérieur du récipient médical (200) au premier trajet de circulation (103).
  3. Système selon les revendications 1 ou 2, dans lequel l'extrémité distale de la seconde enveloppe extérieure (306) comprend un raccord luer.
  4. Système selon la revendication 3, dans lequel le raccord luer comprend un raccord femelle ayant un moyeu configuré pour être vissé dans les filets d'un manchon sur un raccord luer mâle.
  5. Système selon la revendication 1, dans lequel l'extrémité distale de la seconde enveloppe extérieure (306) comprend un corps de seringue (600) solidaire de celui-ci et relié fluidiquement au second trajet d'écoulement de fluide.
  6. Système selon la revendication 1, dans lequel l'extrémité distale de la seconde enveloppe extérieure (306) comprend un assemblage de canule unitaire à celui-ci et relié fluidiquement au second trajet d'écoulement de fluide
  7. Système selon l'une des revendications 1 à 6, dans lequel la première enveloppe extérieure (102) comprend un élément filtrant (800) ou un dispositif de piégeage relié fluidiquement à une ouverture de ventilation (111) configurée pour fournir une égalisation de pression entre le premier trajet d'écoulement de fluide et la pression atmosphérique.
  8. Système selon l'une des revendications 1 à 7, dans lequel le déplacement du boîtier intérieur (307) de sa première position à la seconde position provoque l'extension d'un indicateur d'état comprenant une partie de surface extérieure colorée du boîtier intérieur (307) depuis la seconde enveloppe extérieure (306), l'extension de l'indicateur d'état indiquant une connexion fluide des première et seconde voies de circulation fluide.
  9. Système selon l'une des revendications 1 à 8, dans lequel les extrémités distales et/ou proximales de la première enveloppe extérieure (102) comprennent un joint amovible configuré pour inhiber la contamination microbienne avant l'utilisation de la première enveloppe extérieure (102).
  10. Procédé de connexion d'un récipient de médicament comprenant un médicament fluide à un dispositif d'administration de fluide à un patient, comprenant :
    la fourniture d'un dispositif de transfert de fluide (100) et un dispositif d'actionnement de soupape (300) selon l'une des revendications 1 à 9;
    la connexion fluide de la première voie d'écoulement de fluide (103) au médicament fluide;
    l'accouplement de l'extrémité proximale de la seconde coque extérieure (306) avec l'extrémité distale de la première coque extérieure (102) et rotation de la première coque extérieure (102) par rapport à la seconde coque extérieure (306) pour engager les première et seconde structures d'engagement (103, 301), maintenant ainsi la première coque extérieure (102) sur la seconde coque extérieure (306) dans une configuration verrouillée de manière réversible;
    la rotation de la seconde enveloppe extérieure (306) par rapport au boîtier intérieur (307) de telle sorte que le boîtier intérieur (307) est déplacé de sa première position à sa seconde position, déplaçant ainsi l'élément de pression de sa première position à sa seconde position pour relier de manière fluide les première et seconde voies d'écoulement du fluide ;
    la connexion fluide du dispositif d'administration de fluide patient au second trajet d'écoulement de fluide ; et
    l'écoulement du médicament fluide du récipient de médicament vers le dispositif d'administration de fluide, le procédé comprenant éventuellement en outre:
    la rotation de la seconde coque extérieure (306) par rapport au boîtier intérieur (307) de telle sorte que le boîtier intérieur (307) est déplacé de sa seconde position vers sa première position, ce qui amène le corps élastique (104) à fermer l'ouverture actionnée par pression (105); et
    enlever la première coque extérieure (102) de la seconde coque extérieure (306) en faisant tourner la première coque extérieure (102) par rapport à la seconde coque extérieure (306) pour dégager les première et seconde structures d'engagement (103, 301).
EP14853288.0A 2013-10-18 2014-10-17 Dispositifs de transfert de fluide et leurs systèmes et procédés d'utilisation pour distribuer des fluides médicaux Active EP3057635B1 (fr)

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US201361893066P 2013-10-18 2013-10-18
US201361894027P 2013-10-22 2013-10-22
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