WO2015058136A1 - Fluid transfer devices, systems, and methods for their use in delivering medical fluids - Google Patents

Fluid transfer devices, systems, and methods for their use in delivering medical fluids Download PDF

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Publication number
WO2015058136A1
WO2015058136A1 PCT/US2014/061225 US2014061225W WO2015058136A1 WO 2015058136 A1 WO2015058136 A1 WO 2015058136A1 US 2014061225 W US2014061225 W US 2014061225W WO 2015058136 A1 WO2015058136 A1 WO 2015058136A1
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WO
WIPO (PCT)
Prior art keywords
outer shell
position
fluid flow
flow path
fluid
Prior art date
Application number
PCT/US2014/061225
Other languages
French (fr)
Inventor
David K. Stroup
Original Assignee
Infusion Innovations, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US201361893066P priority Critical
Priority to US61/893,066 priority
Priority to US201361894027P priority
Priority to US61/894,027 priority
Application filed by Infusion Innovations, Inc. filed Critical Infusion Innovations, Inc.
Publication of WO2015058136A1 publication Critical patent/WO2015058136A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202Separating means
    • A61J1/2044Separating means having slits
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2051Connecting means having tap means, e.g. tap means activated by sliding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2055Connecting means having gripping means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2048Connecting means
    • A61J1/2058Connecting means having multiple connecting ports
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/14Details, e.g. provisions for hanging or shape retaining means; Accessories therefor, e.g. inlet or outlet ports, filters or caps
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2079Filtering means
    • A61J1/2082Filtering means for gas filtration

Abstract

It is an object of the present invention to provide fluid transfer devices, systems, and methods for their use in delivering medical fluids to a syringe, a cannula such as an intravenous (IV) line, a patient downstream of the fluid transfer device, etc.

Description

FLUID TRANSFER DEVICES. SYSTEMS. AND METHODS FOR THEIR USE IN

DELIVERING MEDICAL FLUIDS

[0001] The present invention claims priority to U.S. provisional patent application No. 61/893,066, filed October 18, 2013, and to U.S. provisional patent application No. 61/894,027, filed October 22, 2013, each of which is hereby incorporated in its entirety including all tables, figures and claims.

Background of the Invention

[0002] The following discussion of the background of the invention is merely provided to aid the reader in understanding the invention and is not admitted to describe or constitute prior art to the present invention.

[0003] 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. In addition, while it seems counter-intuitive that the health care industry, whose mission is the care of the sick, is itself a "high-hazard" industry for the workers it employs, published studies have shown that workplace exposures to hazardous drugs can cause both acute and chronic health effects such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and possibly leukemia and other cancers.

[0004] Parenteral medications are typically packaged in containers such as vials, ampoules, and flexible bags, from which the medication is administered via a transfer device. In one example, 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. [0005] Assemblies which have hitherto been proposed for the aseptic administration of drugs are described in U.S. Pat. Nos. Des. 271,421, 3,618,637, 3,757,981, 3,826,261, 3,957,052, 3,977,555, 3,993,063, 4,051,852, 4,564,054, 4,604,093, 4,721,133, 4,758,235, 4,967,797, 4,997,430, 5,201,705, 5,269,768, 5,279,576, 5,288,290, 5,334,163, 5,466,220, and 7,326,194, and European Publication Nos: 0 258 913 A2, 0 195 018 B l, 0 192 661 Bl, and 0 416 454 Bl. US2012/0157914, which is hereby incorporated in its entirety, 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. By way of example, 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.

[0006] There remains a need in the art for devices and methods which provide for use and handling of medical preparations with improved the safety and convenience.

Summary of the Invention

[0007] It is an object of the present invention to provide fluid transfer devices, systems, and methods for their use in delivering medical fluids to a syringe, a cannula such as an intravenous (IV) line, a patient downstream of the fluid transfer device, etc.

[0008] In a first aspect, the invention provides a device for controlling fluid flow, referred to herein as a fluid transfer device, comprising:

(i) a first outer shell having a proximal end and a distal end;

(ii) one or more first engagement structures on a surface of the first outer shell at the distal end thereof,

(iii) a first fluid flow path from the proximal to distal end, (iv) a sealing member positioned within the first fluid flow path, the sealing member comprising a resilient body and a pressure-actuated opening in the resilient body configured to reversibly control flow through the first fluid flow path, and

(v) a pressure member movably engaged within the first outer shell on the distal side of the sealing member such that the pressure member is movable relative to the first outer shell from a first position to a second position, the first position configured to permit the resilient body to close the pressure actuated opening, and the second position configured to permit flow through the first fluid flow path by opening of the pressure- actuated opening.

[0009] 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. In a preferred embodiment, the valve actuating device comprises:

(i) a second outer shell having a proximal end and a distal end,

(ii) one or more second engagement structures a surface of the second outer shell at the proximal end thereof, wherein the proximal end of the second outer shell is configured to reversibly mate with the distal end of the first outer shell, and the first and second engagement structures are configured to retain the first outer shell to the second outer shell in a reversibly locked configuration by rotation of the first outer shell relative to the second outer shell,

(iii) a second fluid flow path from the proximal end to the distal end,

(iv) an inner housing movably engaged within the second outer shell such that the inner housing is movable relative to the second outer shell from a first position to a second position by rotational movement of the second outer shell relative to the inner housing, the inner housing comprising a central boss providing a through bore defining at least part of the second fluid flow path,

(v) a sealing pin coupled to the second outer shell and extending into the through bore of the central boss, the sealing pin having a first end which is configured for sealing engagement in the central boss through bore to prevent fluid flow through the second fluid flow path in the first position of the inner housing, and which is configured to permit flow through the second fluid flow path by separating from the central boss in the second position of the inner housing, wherein when the first outer shell and the second outer shell are engaged in the reversibly locked configuration, movement of the inner housing from its first position to its second position applies pressure to the pressure member, thereby moving the pressure member from its first position to its second position to fluidly connecting the first and second fluid flow paths.

[0010] In certain embodiments, 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. Preferably, the packaging is configured to enclose, and to provide a sterile internal environment for, the fluid transfer device and/or the valve actuating device. In addition, or as an alternative, 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.

[0011] In certain embodiments, 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.

[0012] 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. In preferred embodiments, 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, which is hereby incorporated by reference in its entirety. [0013] In certain embodiments, 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.

[0014] In still other embodiments, 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.). Preferably, 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.

[0015] In a related aspect, the devices and systems disclosed herein may be used in methods for the control and/or administration of fluids. Such methods comprise: providing a fluid transfer device and a valve actuating device as described herein; fluidly connecting the first fluid flow path to the fluid medication; mating the proximal end of the second outer shell with the distal end of the first outer shell and rotating the first outer shell relative to the second outer shell to engage the first and second engagement structures, thereby retaining the first outer shell to the second outer shell in a reversibly locked configuration; rotating the second outer shell relative to the inner housing such that the inner housing is moved from its first position to its second position, thereby moving the pressure member from its first position to its second position to fluidly connect the first and second fluid flow paths; fluidly connecting the patient fluid delivery device to the second fluid flow path; and inducing flow of the fluid medication from the medication container to the fluid delivery device.

[0016] Optionally, 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.

[0017] As used herein, "proximal" refers to a first end of the device and "distal" refers to a second opposite end of the device.

[0018] "Actuated" refers to the condition in which the fluid path is opened to allow fluid to transfer freely along the fluid path, while "deactuated" refers to the condition in which the fluid path is closed and fluid transfer is not permitted.

[0019] "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. 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.

[0020] The details of one or more embodiments of the disclosure are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the disclosure will be apparent from the description and drawings, and from the claims.

Brief Description of the Drawings

[0021] Fig. 1 depicts an exemplary embodiment of a fluid transfer device of the present invention adapted for use with a fluid vial.

[0022] Fig. 2 depicts an alternate view of the exemplary embodiment of a fluid transfer device of the present invention.

[0023] Fig. 3 depicts a cross-sectional view of the exemplary embodiment of a fluid transfer device of the present invention. [0024] Fig. 4 depicts a cross-sectional view of the exemplary embodiment of a fluid transfer device of the present invention in fluid communication with the interior of a fluid vial.

[0025] Fig. 5 depicts an exploded view of a fluid transfer device and a corresponding valve actuating device according to the present invention.

[0026] Fig. 6 depicts a cross-sectional view of the exemplary embodiment of a fluid transfer device and a corresponding valve actuating device of the present invention in fluid communication with the interior of a fluid vial.

[0027] Fig. 7 depicts an alternative configuration of a fluid transfer device of the present invention adapted for use with an IV bag.

[0028] Fig. 8 depicts a configuration of a fluid transfer device of the present invention comprising a flexible enclosure which provides an entrapment reservoir such that any aerosol that exits the vial is entrapped within the enclosure.

[0029] Fig. 9 depicts assembly of a configuration of a fluid transfer device of the present invention comprising a flexible enclosure which provides an entrapment reservoir.

[0030] Fig. 10 depicts assembly of a configuration of a fluid transfer device of the present invention comprising a flexible enclosure which provides an entrapment reservoir.

[0031] Fig. 11 depicts assembly of a configuration of a fluid transfer device of the present invention comprising a flexible enclosure which provides an entrapment reservoir.

[0032] Fig. 12 depicts assembly of a configuration of a fluid transfer device of the present invention comprising a flexible enclosure which provides an entrapment reservoir.

[0033] Fig. 13 depicts a configuration of a fluid transfer device of the present invention comprising a physical capture device that prevents aerosolization of vial contents such that any aerosol that exits the vial is entrapped within the physical capture device.

[0034] Fig. 14 depicts an alternate view of the configuration of a fluid transfer device of the present invention comprising a physical capture device that prevents aerosolization of vial contents such that any aerosol that exits the vial is entrapped within the physical capture device.

[0035] Fig. 15 depicts a configuration of a fluid transfer device of the present invention comprising a physical capture device in the form of a filter that prevents aerosolization of vial contents such that any aerosol that exits the vial is captured by the physical capture device.

[0036] Fig. 16 depicts an alternate view of the configuration of a fluid transfer device of the present invention comprising a physical capture device in the form of a filter that prevents aerosolization of vial contents such that any aerosol that exits the vial is captured by the physical capture device.

Detailed Description of the Invention

[0037] 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. As shown, the lower skirt of fluid transfer device 100 may be configured to snap fit over the top flange of a standard medical vial.

[0038] As shown in FIG. 2, following removal of protective cover 101, fluid transfer device 100 includes a lumen having an engagement structure 103. In this example, the lumen is configured as a female bore to receive a valve actuating device 300 (shown in Fig. 5) inserted thereinto. One of skill in the art will understand that 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. [0039] 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.

[0040] 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.

[0041] 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.

[0042] As depicted in Fig. 3, 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.

[0043] Fig. 4 provides a cross-sectional view of fluid transfer device 100 in position on medicinal vessel 200. In this example, 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. Upon removal of top seal 101, the lumen of fluid transfer device 100 is ready to accept valve actuating device 300. As noted above and depicted in Fig. 5, "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.

[0044] 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. In this exemplary embodiment, the connector threads and boss are depicted as a male luer connector. The skilled artisan will understand that 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.

[0045] 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.

[0046] In the open position, the inner housing 307 moves away from the sealing pin to open a passageway around the pin and through the open end of the boss. In one embodiment, 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. By rotation of the inner housing 307 relative to the outer shell 306, the inner housing 307 is directed from the first position to the second position (downward from the position depicted in Fig. 6) to open a fluid path through the valve, e.g., through the fluid passage, the annular passage within the boss around the sealing pin, and out through the outlet opening of the boss when the boss moves away from the sealing pin.

[0047] In addition to opening of the flow path through valve actuating device 300, 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. Thus, 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.

[0048] The inner housing may include one or more status indicators, e.g., that provide a visual indication when the fluid path is open. By way of example, by rotation of the inner housing 307 relative to the outer shell 306, a colored portion of the inner housing is exposed, e.g. through a window in the outer shell.

[0049] The skilled artisan will understand that a number of polymers may be used to form the components of fluid transfer device 100 and valve actuating device 300, including thermoplastics, some thermosets, and elastomers. Common thermoplastics include PMMA, cyclic olefin copolymer, ethylene vinyl acetate, polyacrylate, polyaryletherketone, polybutadiene, polycarbonate, polyester, copolyesters,

polyetherimide, polysulfone, nylon, polyethylene, and polystyrene. Common 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.

[0050] Optionally, 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. For example, 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. In addition or alternatively, 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.

[0051] After sufficient fluid is delivered or if it is otherwise desired to close the fluid path, counter-rotation of the inner housing 307 relative to the outer shell 306 causes the inner housing to return from the second (open) position to the first (closed) position. In doing so, the tip of the sealing pin 303 again engages seal 304 to substantially seal the fluid passage and close the fluid path. This action may create a slight vacuum within the valve actuating device 300, thereby drawing any excess fluid into valve actuating device 300 rather than risking the fluid leaking from the valve. Such a "negative bolus" effect may be useful if the fluid is corrosive or toxic, e.g., to reduce exposure of the fluid to an operator of the valve 10 and/or a patient being treated with the fluid. Additionally, this counter-rotation also relieves the downward force of actuating plunger 106 on resilient body 104, permitting the resilient nature of the material to close pressure actuated opening 105.

[0052] While fluid transfer device 100 is depicted in the above description as adapted to fit on a vial, the skilled artisan will readily envision other, alternative, embodiments. By way of example, 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. 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. As noted 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.

[0053] 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.

[0054] By way of example, 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. As shown in Fig 9, 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. 10, thereby sealing the pouch at the surface of base member 102. Following this, 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. At this point, a syringe 600 mated to valve actuating device 300 may be used to withdraw contents from the vial as described above.

[0055] Alternative embodiments for preventing aerosolization of the vial contents are shown in Figs. 13 to 16. In these embodiments, 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. In the case of physical capture device 700, 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. Similarly, a subsequent extraction of material from the vial into syringe 600 will move the plunger of syringe 700 inward. In the case of filter 800, 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.

[0056] While the invention has been described and exemplified in sufficient detail for those skilled in this art to make and use it, various alternatives, modifications, and improvements should be apparent without departing from the spirit and scope of the invention. The examples provided herein are representative of preferred embodiments, are exemplary, and are not intended as limitations on the scope of the invention.

Modifications therein and other uses will occur to those skilled in the art. These modifications are encompassed within the spirit of the invention and are defined by the scope of the claims.

[0057] The use of "or" herein means "and/or" unless stated otherwise. Similarly, "comprise," "comprises," "comprising" "include," "includes," and "including" are interchangeable and not intended to be limiting.

[0058] It is to be further understood that where descriptions of various embodiments use the term "comprising," those skilled in the art would understand that in some specific instances, an embodiment can be alternatively described using language "consisting essentially of or "consisting of." [0059] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although any methods and reagents similar or equivalent to those described herein can be used in the practice of the disclosed methods and compositions, the exemplary methods and materials are now described.

[0060] All publications mentioned herein are incorporated herein by reference in full for the purpose of describing and disclosing the methodologies, which are described in the publications, which might be used in connection with the description herein. All patents and publications mentioned in the specification are indicative of the levels of those of ordinary skill in the art to which the invention pertains prior to the filing date of the disclosure. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate such disclosure by virtue of prior disclosure.

[0061] It will be readily apparent to a person skilled in the art that varying

substitutions and modifications may be made to the invention disclosed herein without departing from the scope and spirit of the invention.

[0062] The invention illustratively described herein suitably may be practiced in the absence of any element or elements, limitation or limitations which is not specifically disclosed herein. Thus, for example, in each instance herein any of the terms

"comprising", "consisting essentially of and "consisting of may be replaced with either of the other two terms. The terms and expressions which have been employed are used as terms of description and not of limitation, and there is no intention that in the use of such terms and expressions of excluding any equivalents of the features shown and described or portions thereof, but it is recognized that various modifications are possible within the scope of the invention claimed. Thus, it should be understood that although the present invention has been specifically disclosed by preferred embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims.

[0063] Other embodiments are set forth within the following claims.

Claims

We claim:
1. A system for controlling fluid flow, comprising:
(a) a fluid transfer device comprising
(i) a first outer shell having a proximal end and a distal end;
(ii) one or more first engagement structures on a surface of the first outer shell at the distal end thereof,
(iii) a first fluid flow path from the proximal to distal end,
(iv) a sealing member positioned within the first fluid flow path, the sealing member comprising a resilient body and a pressure-actuated opening in the resilient body configured to reversibly control flow through the first fluid flow path, and
(v) a pressure member movably engaged within the first outer shell on the distal side of the sealing member such that the pressure member is movable relative to the first outer shell from a first position to a second position, the first position configured to permit the resilient body to close the pressure actuated opening, and the second position configured to permit flow through the first fluid flow path by opening of the pressure- actuated opening; and
(b) a valve actuating device comprising
(i) a second outer shell having a proximal end and a distal end,
(ii) one or more second engagement structures a surface of the second outer shell at the proximal end thereof, wherein the proximal end of the second outer shell is configured to reversibly mate with the distal end of the first outer shell, and the first and second engagement structures are configured to retain the first outer shell to the second outer shell in a reversibly locked configuration by rotation of the first outer shell relative to the second outer shell,
(iii) a second fluid flow path from the proximal end to the distal end,
(iv) an inner housing movably engaged within the second outer shell such that the inner housing is movable relative to the second outer shell from a first position to a second position by rotational movement of the second outer shell relative to the inner housing, the inner housing comprising a central boss providing a through bore defining at least part of the second fluid flow path,
(v) a sealing pin coupled to the second outer shell and extending into the through bore of the central boss, the sealing pin having a first end which is configured for sealing engagement in the central boss through bore to prevent fluid flow through the second fluid flow path in the first position of the inner housing, and which is configured to permit flow through the second fluid flow path by separating from the central boss in the second position of the inner housing, wherein when the first outer shell and the second outer shell are engaged in the reversibly locked configuration, movement of the inner housing from its first position to its second position applies pressure to the pressure member, thereby moving the pressure member from its first position to its second position to fluidly connecting the first and second fluid flow paths.
2. A system according to claim 1, wherein the first outer shell comprises a spike member at the proximal end thereof configured to insert into the septum of a medication container and fluidly connect the interior of the medical container to the first flow path.
3. A system according to claim 1 or 2, wherein the distal end of the second outer shell comprises a luer fitting.
4. A system according to claim 3, wherein the luer fitting comprises a female fitting having a hub configured to screw into threads in a sleeve on a luer male fitting.
5. A system according to claim 1, wherein the distal end of the second outer shell comprises a syringe barrel unitary thereto and fluidly connected to the second fluid flow path.
6. A system according to claim 1, wherein the distal end of the second outer shell comprises a cannula assembly unitary thereto and fluidly connected to the second fluid flow path
7. A system according to one of claims 1-6, wherein the first outer shell comprises a filter element or entrapment device fluidly connected to a vent aperture configured to provide pressure equalization between the first fluid flow path and atmospheric pressure.
8. A system according to one of claims 1-7, wherein movement of the inner housing from its first position to the 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.
9. A system according to one of claims 1-8, wherein the distal and/or proximal ends of the first outer shell comprise a removable seal configured to inhibit microbial contamination prior to use of the first outer shell.
10. A medical device, comprising: a fluid transfer device comprising:
(i) a first outer shell having a proximal end and a distal end;
(ii) one or more first engagement structures on a surface of the first outer shell at the distal end thereof,
(iii) a first fluid flow path from the proximal to distal end,
(iv) a sealing member positioned within the first fluid flow path, the sealing member comprising a resilient body and a pressure-actuated opening in the resilient body configured to reversibly control flow through the first fluid flow path, and
(v) a pressure member movably engaged within the first outer shell on the distal side of the sealing member such that the pressure member is movable relative to the first outer shell from a first position to a second position, the first position configured to permit the resilient body to close the pressure actuated opening, and the second position configured to permit flow through the first fluid flow path by opening of the pressure- actuated opening; and packaging configured to enclose, and to provide a sterile internal environment for, the fluid transfer device.
11. A medical device according to claim 10, wherein the first outer shell comprises a spike member at the proximal end thereof configured to insert into the septum of a medication container and fluidly connect the interior of the medical container to the first flow path.
12. A medical device according to one of claims 10 or 11, wherein the first outer shell comprises a filter element or entrapment device fluidly connected to a vent aperture configured to provide pressure equalization between the first fluid flow path and atmospheric pressure.
13. A medical device according to one of claims 10-12, wherein movement of the inner housing from its first position to the 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.
14. A medical device according to one of claims 10-13, wherein the distal and/or proximal ends of the first outer shell comprise a removable seal configured to inhibit microbial contamination prior to use of the first outer shell.
15. A method of connecting a medication container comprising a fluid medication to a patient fluid delivery device, comprising: providing a fluid transfer device and a valve actuating device according to one of claims 1-9; fluidly connecting the first fluid flow path to the fluid medication; mating the proximal end of the second outer shell with the distal end of the first outer shell and rotating the first outer shell relative to the second outer shell to engage the first and second engagement structures, thereby retaining the first outer shell to the second outer shell in a reversibly locked configuration; rotating the second outer shell relative to the inner housing such that the inner housing is moved from its first position to its second position, thereby moving the pressure member from its first position to its second position to fluidly connect the first and second fluid flow paths; fluidly connecting the patient fluid delivery device to the second fluid flow path; and inducing flow of the fluid medication from the medication container to the fluid delivery device.
16. A method according to claim 15, further comprising: 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.
PCT/US2014/061225 2013-10-18 2014-10-17 Fluid transfer devices, systems, and methods for their use in delivering medical fluids WO2015058136A1 (en)

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