WO2003072162A2 - Probe-activated medicament injector device - Google Patents

Probe-activated medicament injector device Download PDF

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Publication number
WO2003072162A2
WO2003072162A2 PCT/US2003/005535 US0305535W WO03072162A2 WO 2003072162 A2 WO2003072162 A2 WO 2003072162A2 US 0305535 W US0305535 W US 0305535W WO 03072162 A2 WO03072162 A2 WO 03072162A2
Authority
WO
WIPO (PCT)
Prior art keywords
injector
vial
injector assembly
nozzle
check valve
Prior art date
Application number
PCT/US2003/005535
Other languages
French (fr)
Other versions
WO2003072162A3 (en
Inventor
Mitali Dutt
Alfredo Perez
Original Assignee
Mitali Dutt
Alfredo Perez
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
Application filed by Mitali Dutt, Alfredo Perez filed Critical Mitali Dutt
Priority to AU2003217677A priority Critical patent/AU2003217677A1/en
Publication of WO2003072162A2 publication Critical patent/WO2003072162A2/en
Publication of WO2003072162A3 publication Critical patent/WO2003072162A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2422Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2429Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by telescoping of ampoules or carpules with the syringe body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3117Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3121Means preventing contamination of the medicament compartment of a syringe via the proximal end of a syringe, i.e. syringe end opposite to needle cannula mounting end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M2005/3128Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/34Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/344Constructions for connecting the needle, e.g. to syringe nozzle or needle hub using additional parts, e.g. clamping rings or collets

Definitions

  • the present invention relates to a medicament injector device, and more particularly to a probe-activated medicament injector device suitable for the administration of a hazardous liquid.
  • U.S. Patent No. 5,019,052 concerns a bipartite injector device formed of an outer shell having a closed end with a bore leading to an external spout, and an open end to receive the stoppered end of a medicament vial, and an inner sleeve having a cantilever end connectable to the shell closed end, and a free end with a socket connectable to the vial stopper, plus a hollow needle mountable at one end by the sleeve to communicate with the bore and to dispose its other pointed end in the socket to penetrate the stopper to communicate with the vial, the shell and sleeve having connector formations for coaxial snap fit cantilever interlocking and fluid tight flow connection of the parts.
  • U.S. Patent No. 5,060,704 the entire content of which is also hereby incorporated by reference, relates to a suction transfer assembly of a vial having a chamber filled with a medicament liquid, such as a hazardous liquid, and closed by a stopper on which the vial is longitudinally slidable, and a flow path containing an adapter connectable on one end to the vial by a hollow needle that penetrates the stopper, and on the other end to a suction operating dispenser device, e.g.
  • a medicament liquid such as a hazardous liquid
  • a syringe lockably connectable to the adapter at a check valve in the flow path to transfer liquid from the vial to the device, with simultaneous compensating vial movement relative to the stopper under external atmospheric pressure to reduce the chamber volume by an amount equal to the liquid transferred, yet preventing leakage from the adapter on disconnecting the device.
  • transfer and injector constructions are known, as noted in the above-mentioned patents, the prior art does not allow for direct injection of hazardous fluids.
  • U.S. Patent No. 5,060,704 is a transfer device which allows for suction of the medicament from the vial to a syringe type device for subsequent administration via an intermediary adapter, while U.S. Patent No. 5,019,052 only allows for injection of non-hazardous fluids since the design does not incorporate any safety features to prevent leakage or drug exposure. Accordingly, there is a long felt need in the art for an injector device capable of the direct administration of a hazardous fluid
  • the present invention may effectively contains a hazardous fluid within the internal chamber of an injector device until released upon probe activation, thereby protecting the health care provider from hazardous fluid exposure. Additionally, the present invention allows for direct administration of the hazardous fluid, and therefore is no longer merely a transfer device.
  • the present invention overcomes the disadvantages of the prior art by providing a probe-activated medicament bipartite injector device formed of an outer shell and inner sleeve connected in cantilever manner to the shell for fluid tight flow of a medicament between a vial connected to one end of the device and a mechanically activated, normally closed valve at the other end of the device.
  • the valve end of the device may in turn be connected to a separate charging or dispensing device.
  • an injector device is advantageously provided which comprises a longitudinal hollow outer shell, a separate cylindrical inner sleeve, and a normally closed check valve that defines a fluid path of the device.
  • the outer shell preferably has a front closed end, a rear open end and a cylindrical inner wall forming an interior to receive coaxially through the open end, and guide for movement relative thereto, a cylindrical medicament vial closed by a penetrable stopper.
  • a central hub extends through the closed end from an external spout to a circular seat in the shell interior and has a bore extending from the spout to the seat.
  • the shell also preferably has a radially inwardly directed circular constriction ring on the inner wall adjacent the closed end and a radially inwardly facing circular locking groove defined axially on the wall between the ring and closed end.
  • the inner sleeve preferably has a front cantilever mounting end with a radially outwardly directed flange terminating peripherally in a circular compression rim, a central needle mounting portion, and a rear free end having a cylindrical socket to connect the vial stopper stationarily thereto, and includes a hollow needle with a front circular collar flange and rear pointed end.
  • the inner sleeve is preferably sized for location in the outer shell sufficiently radially inwardly of the inner wall to permit insertion of the vial therebetween, and the rim is sized for compression displacement through the ring and snap fit locking in the groove to mount the sleeve coaxially in the shell with the sleeve front end in cantilever stationary connection with the shell closed end.
  • the needle mounting portion is preferably arranged to mount the needle coaxially and in fluid tight condition relative to the bore and sleeve such that the needle pointed end is disposed coaxially in the socket to penetrate the stopper for protected fluid tight flow between the vial and nozzle through the needle and bore.
  • the shell has a radial front wall forming its closed end, and the sleeve flange is preferably sized and arranged to abut that wall when the rim and groove are in locking engagement.
  • the injector device of the present invention is thus preferably formed of an outer shell having a closed front end with a bore and an internal seat which seals with a mechanical probe-openable and self-closing check valve and an inner sleeve having a front end connection to the outer shell front end for a snap fit cantilever locking therewith to provide a tight coaxial and concentric arrangement of parts, and a rear free end opened to receive the stoppered end of a medicament vial with a socket connectable to the vial stopper plus a hollow needle having a front collar flange mountable via the sleeve and its rear pointed end for penetration of the stopper.
  • a preferred embodiment of the present invention provides an injector assembly for transfer and direct administration of fluid from a vial.
  • the injector assembly comprises an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, the check valve comprising a mechanical contact probe- openable and self-closing valve and an internal flow path extending therethrough.
  • the injector assembly further comprises an accessory device including an adapter attachable to the closed front end of the injector device, the adapter including a rear end having a contact portion arranged for flow connection with the nozzle of the injector device and for opening the check valve, a forward end for connection to a desired apparatus, and an internal flow path extending therethrough.
  • the injector assembly thereby defines a fluid path such that on attaching the adapter to the nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into the accessory device for delivery to the desired apparatus.
  • a further preferred embodiment of an injector assembly according to the present invention comprises a vial forming an enclosed longitudinal chamber for holding a medicament liquid and having an open end closed by a penetrable stopper, the vial being slidable longitudinally relative to the stopper and the stopper slidably sealing the liquid in the chamber in any position of vial sliding movement, the stopper having fastening means facing the vial open end; an injector device having a rear open end for receiving the medicament fluid containing vial, a rearwardly facing hollow needle with a pointed tip being insertable into the vial open end to fasten the injector device to the vial and to penetrate the stopper by the needle, a front closed end including a nozzle and a check valve, said check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough; and an accessory device comprising an adapter attachable to the closed front end of the injector device, the adapter including a rear end having a contact portion arranged for flow connection with the nozzle
  • the injector assembly thereby defines a fluid path such that on attaching the adapter to the nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into the accessory device for delivery to the desired apparatus.
  • a further preferred embodiment of the present invention is directed to an injector assembly for transfer and direct administration of fluid from a vial.
  • the injector assembly comprises an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, the check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough, the front closed end of the injector device being configured for cooperation with a contact portion arranged for flow connection with the nozzle of the injector device and for opening the check valve.
  • the injector assembly thereby defines a fluid path such that when the front closed end cooperates with the contact portion, the check valve opens for transfer and direct administration of fluid from the vial and through the injector device.
  • FIG. 1 is a schematic sectional view of a preferred embodiment of the injector device showing the stoppered vial and injector in unassembled condition.
  • FIG. 2 is an enlarged partial view of the FIG. 1 device, showing the snap fitting of the sleeve to the shell and showing the mechanically activated valve assembly in a closed position.
  • FIG. 3 is an enlarged partial view of the FIG. 1 device, showing the snap fitting of the sleeve to the shell and showing the mechanically activated valve assembly in an open position.
  • injector assembly 1 includes an injector device 2, which operates with an accessory device comprising an adapter 48, and a conventional cylindrical medicament liquid containing receiving vial 4, such as a plunger vial, at the rear end of injector device 2.
  • the injector device 2 has a longitudinal, preferably cylindrical, hollow outer shell 26 and a cylindrical inner sleeve 27, a centrally mounted needle 42, and a check valve 5, which is described in detail below.
  • Shell 26 has a preferably circular rear open end 24 and a front end 76 including a bore 19, a circular valve seat 18 and a sealing ring 16 which seats check valve 5.
  • the rear open end 24 of shell 26 preferably mates with a rear protective cap 28 to maintain sterility of the injector device via mechanical interference of an outer shell cap circumferencial rib 29 and a protective cap groove 23.
  • the front end of nozzle 11 may be provided with a protective valve cap 6 to maintain sterility until the assembly is ready to be used (Figs. 1 and 2).
  • the protective valve cap 6 may then be removed and an adapter 48, such as the illustrated male-male luer coupler, may be connected to the front end of device 2 (Fig. 3).
  • the shell 26 outwardly confines the nozzle 11 at its closed end to connect thereto a separate infusion or dispensing device (not shown) for fluid tight flow between the vial 4 and an administration device via the needle 42, nozzle 11, and male luer coupler accessory device 48.
  • the nozzle 11 may have a luer lock connector 10 mating the male luer coupler 48 via a screw thread counterpart connector 81 for a releasable interconnection.
  • the interconnection thus formed is similar to a screw and nut mechanism and will not disengage during normal use.
  • the outer edge of rear end 74 of inner sleeve 27 may have a circumferen- tial counterpart formation of ratchets 40 and associated bosses 41 at the outer end of threads 39 in a socket 75 which are arranged to coact with the stopper recess 63 and bosses 64 for a locking grip therebetween when the injector device 2 is rotated onto stopper 56 to achieve their interconnection and the penetration of the stopper seal 57 by the needle tip 47.
  • the inner sleeve socket threads 39 reach full rotational engagement with the stopper threads 58, the inner sleeve ratchets 40 and bosses 41 engage the stopper recess 63 and bosses 64 to snap-lock in the stopper recess 63, such that the respective ratchets, bosses and recesses form coacting separation inhibiting means to prevent separation of the injector device 2 from the stopper 56.
  • the cylindrical inner wall 25 of the outer shell 26 forms an interior cavity to coaxially receive, via end 24, the guide vial 4 for relative longitudinal and rotational movement.
  • the open end 69 of the vial 4 is closed by a shiftable cylindrical, needle penetrable, stopper 56 having ridges 62 to seal the contents thereof, e.g., a medicament or liquid L.
  • a removable cap 55 may also be provided prior to use.
  • the inner wall 25 has a radially inwardly directed circular constriction ring
  • Ring 20 adjacent the front end and a radially inwardly facing circular locking groove 21 defined axially thereon between ring 20 and the radial front wall forming closed front end 76.
  • Ring 20 is preferably formed as a hollow, frustoconical insert ramp
  • the inner wall 25, the ring 20, the groove 21 and the sealing ring 16 are preferably circular in cross section, concentric and coaxial, and the bore 19 preferably extends along the center axis of the shell 26.
  • the rear end 24 preferably has lateral flanges 22 formed as finger grips to aid in the handling of injector device 2 during use, and a groove formation 23 to receive an aseptic friction fit closure cap 28 to keep the injector device 2 sterile prior to connection and use with the vial 4.
  • a similar cap 6 may protect the spout of nozzle 11 at the front end 76.
  • the inner sleeve 27 has a front cantilever mounting end 31 and a rear free end 74.
  • the front end 31 has a radially outwardly directed circular flange 32 terminating peripherally in a circular compression rim 77, sized and arranged to coact with the ring 20 and the groove 21 to thereby connect the front end 31 of the sleeve 27 in cantilever manner to the front end 76 of the shell 26.
  • the front end 31 has a radially outwardly directed circular flange 32 terminating peripherally in a circular compression rim 77, sized and arranged to coact with the ring 20 and the groove 21 to thereby connect the front end 31 of the sleeve 27 in cantilever manner to the front end 76 of the shell 26.
  • the passage 78 preferably tapers from the recess 33 to the extension 38.
  • Under flange space 79 defines a concentric compression compensation space to aid local compression displacement of the rim 77 through the ring 20 for snap fit locking in the groove 21.
  • the recess 33 is sized and arranged to receive the valve luer 12 of the valve 5 in fluid tight condition and to thus communicate the bore 13 with the passage 78.
  • the remainder of the inner sleeve 27 interior at the extension 38 forms an annular space 36 within rearward cylindrical extension 38 having internal luer lock threads 37.
  • a hollow needle 42 is disposed in a cylindrical extension 80 with its externally threaded front circular collar flange 45 (which may be tapered) mounted in fluid tight condition on central extension 38 via the internal threads 37 on extension 38 to communicate with the passage 78.
  • the needle is preferably a conventional metal needle, such as a standard, regular bevel (B-D I.V. 166A. times.11/2"), although other needles could of course also be used.
  • This mounting also positions the rear pointed end of the needle 42 coaxially in a socket 75, in the rear end 74 at the remote portion of the sleeve extension 80, and centrally of the socket internal threads 39, within the sleeve outer wall 71.
  • the rim 77, recess 33, extension 38, sleeve extension 80, socket 75 and outer wall 71 are preferably circular in cross section, concentric and coaxial, and the passage 78 preferably extends along the center axis of the sleeve 27.
  • the recess 33, central extension 38, socket 75 and cylindrical extension 80 provide a central needle mounting portion between rim 77 and socket 75, so that when rim 77 firmly locks in the groove 21, the recess 33 automatically firmly seats against valve luer 12, and the threads 37 selectively adjustably engage the threaded collar flange 36 to automatically locate the needle 42 to seat the flange 45 automatically firmly against the extension 38, for fluid tight flow between the needle 42 and the nozzle 11 via the passage 78 and the bore 13.
  • the needle mounting portion 85 has a forwardly facing central circular recess 33 at the sleeve front end, a rearwardly facing central circular extension 36 and a passage 78 from the recess to the extension, the recess, extension and rim 86 being coaxial.
  • the collar flange 45 is arranged for coaxial mounting on the extension, and the recess is arranged to receive the seat 46 coaxially.
  • the needle mounting portion has connector means 37 and the collar flange has counterpart connector means 87 to connect the needle to the sleeve at the extension.
  • the needle mounting portion has a central circular hollow recess formation with a circular shoulder, the formation, shoulder and rim being coaxial, and the formation and shoulder sized to receive and engage the collar flange with the formation peripherally embracing it and the shoulder axially locating it to mount it on the seat.
  • the recess formation includes a forwardly facing larger diameter central circular neck recess at the sleeve front end outwardly bounded by a forward thin wall neck extending rearwardly from the sleeve flange, and a rearwardly facing smaller diameter central circular shank recess outwardly bounded by a thick wall shank extending rearwardly from, and separated by the shoulder from, the neck.
  • the shoulder is arranged to locate the collar flange rearwardly of the forward-most neck extent, and the neck is sized to aid the rim compression displacement through the ring to lock in the groove.
  • the shell and sleeve are plastic for snap fit cantilever connection to form the injector device, the needle is preferably metal, and the check valve is also preferably plastic.
  • the shell 26 and sleeve 27 are most preferably formed as injection molded plastic pieces, to promote their snap fit cantilever locking and fluid tight connection, and enable use of low cost dies of simple design, yet of precise dimension and shape, to fabricate these two pieces with conforming parts accurately mating to achieve their desired concentric and coaxial alignment relationship that is essential to proper alignment with the vial 4 during use.
  • the shell 26 and sleeve 27 may be sized for different volume dosages (for example, 10 mL to 50 mL dosages) with concordantly sized vials.
  • the shell and the sleeve have coacting connector formations for snap fit cantilever interlocking
  • the check valve and the shell have coacting connector formations for press-fit assembly.
  • the above-described parts of the injector device 2 are precisely formed, sized, shaped and arranged, relative to each other to maintain their snap fit cantilever interconnection, with their parts in accurate centered alignment, and especially with the given, i.e. cantilever mounted, standard needle centered relative to the sleeve socket, which centering is advantageous for vial stopper center puncturing without misalignment or other mishap regarding safety of the patient and the user of the device.
  • the ring and groove are formed on the shell, and the flange and rim are formed on the sleeve, as integral parts, they will be more precisely centered and axially positioned, e.g. to tolerances controlled by the injection molding process, for more accurate coaxial alignment of the needle mounted thereon with the stopper entrance of the vial, to achieve easy, rapid and safe screwing of the stopper into the socket without needle and stopper bore misalignment.
  • the internal threads 39 in socket 75 connect the stopper 56 of vial 4 stationarily thereto when open end 69 is screwed therein via stopper external threads 58.
  • the vial 4 may be pushed between shell inner wall 25 and sleeve outer wall 71, preferably having circumferentially spaced longitudinal guide ribs 72 (shown in Fig. 2) along the vial guideway 73.
  • the ribs 72 selectively radially size the annular gap of guideway 73, i.e. between the outer radius of sleeve ribs 72 and inner radius of shell wall 25, to conform to the vial 4 radial dimensions, while conserving material and lightening the structure without detracting from the robust structural integrity of sleeve 27, in that the circumferential arc portions between ribs 72 constitute excavated spaces on outer wall 71.
  • the ribs 72 thus inhibit excess angular movement between the shell 26, sleeve 27 and vial 4, and misalignment between the needle 42 and stopper entrance 70.
  • the ribs 72 are removed from Figs. 1 and 3 for clarity of illustration.
  • the vial 4 When a vial 4 holding a medicament fluid is inserted in the guideway 73 and the stopper 56 is screwed into the socket 75 to cause the needle 42 to enter stopper entrance 70 and puncture the seal 57, the vial 4 may be pushed further into injector device 2 while the stopper 56 is stationarily connected to the socket 75, to force medicament L from the filled rear half of the vial 4 via needle 42, passage 78 and bore 13 to nozzle 11, when for example it is connected to a separate dispensing device.
  • the various parts are desirably sized to position the needle pointed end coaxially in the socket slightly inwardly of the sleeve open end sufficiently to protect the needle from unintended human contact thereat. Due to the precise fluid tight fit of the associated internal parts of the injector device 2, the flow path from the vial through the needle via passage 78 and bore 13 in device 2 is completely protected and entirely free of dead spaces.
  • the check valve 5 and male luer coupler 48 facilitate use and prevent accidental leaks and exposure to hazardous medicaments, as described in detail below.
  • the injector device 2 may be provided as a one-time use discardable item and the injector device may be fabricated from conventional materials and components and assembled in simple and inexpensive manner.
  • check valve 5 faces the hollow nozzle 11 which defines the front terminus of flow path 14.
  • Check valve 5 is preferably a mechanical contact probe-openable and self-closing valve, as described in the afore-mentioned U.S. Patent No. 5,060,704.
  • Valve 5 is preferably formed of a resilient diaphragm 8 having a forwardly facing hollow tubular nose 7 provided with liquid inflow apertures 67, and it is situated in a valve chamber 68 with an outer edge perimeter of diaphragm 8 rigidly seated on the interior chamber wall 9. As illustrated in FIG. 2, check valve 5 is in a closed position.
  • Nose 7 defines a valve plunger which projects into the internal bore of nozzle 11 while diaphragm 8 seats sealingly against the adjacent wall 9 of valve chamber 68 when valve 5 is in a normally self-closed position.
  • nose 7 is contacted by the probe and urged inwardly to lift diaphragm 8 from its seated position and thereby open valve 5.
  • the accessory device comprises a male-male luer coupler or adapter 48 including a first male luer 51 disposed on a front end 53 and second male luer 51 on a back end 54 of the adapter 48.
  • a rear extension 54a of the rear end 54 thus defines a probe, or contact portion, which, when inserted into the nozzle 11 (preferably comprising a female luer), engages the nose or valve plunger 7 and displaces the nose 7 rearwardly a sufficient distance such that the spaced fingers 7a, 7b of the nose 7 extend past the chamber wall 9 and thereby unseat the diaphragm 8 from its seated position against the wall 9. In so doing, fluid communication is established throughout the injector assembly 1.
  • Nozzle 11 which preferably defines a female luer, valve 5, diaphragm 8, nose 7, apertures 67, chamber 68 and a luer lock 10, may be formed as a separate commercial add-on valve assembly, such as, for example, a valve assembly of the type shown in U.S. Pat. No. 4,535,820, the entire contents of which are hereby incorporated by reference.
  • valve assembly would then be mounted by connection of valve male luer 12 and the inner sleeve female luer which includes an annular valve seat or recess 34 in the inner sleeve 27 at front end 31, and a hollow annular extension 33, with the valve bore 13 within the central extension 33 communicating with the inner end of needle 42 at the interface to form a part of the flow path 14 in injector device 2.
  • the various components of the injector assembly 1 of the present invention thus communicate to form a fluid path 78, 14 so that on locking a counterpart nozzle 51 of the accessory device 48 to the check valve nozzle 11, the probe or mechanical contact portion, such as the rear extension 54a of the accessory device 48, opens the check valve 5 for transfer and direct administration of fluid from the vial 4 through the injector device 2 and into a further apparatus (not shown) connectable to the forward end of the accessory device 48.
  • the present invention thus allows for hazardous medicaments or other fluids to be directly injected while minimizing the risk of leakage or endangering the lives of hospital or other health care providers.

Abstract

An injector assembly (1) for transfer and direct administration of fluid from a vial (4). The injector assembly (1) includes an injector device (2) having a rear open end (24) for receiving a medicament fluid containing vial, a front closed end including a nozzle (11) and a check valve (5). The check valve includes a mechanical contact probe-openable and self-closing valve and an internal flow path extending therethrough. The front closed end of the injector device is configured for cooperation with a contact portion arranged for flow connection with the nozzle (11) of the injector device (2) and for opening the check valve (5). The injector assembly thereby (1) defines a fluid path such that when the front closed end cooperates with the contact portion, the check valve (5) opens for transfer and direct administration of fluid from the vial (4) and through the injector device (2).

Description

PROBE-ACTIVATED MEDICAMENT INJECTOR DEVICE
TECHNICAL FIELD The present invention relates to a medicament injector device, and more particularly to a probe-activated medicament injector device suitable for the administration of a hazardous liquid.
BACKGROUND OF THE INVENTION
The use of medicament injector devices is well known in the art, as shown for example in U.S. Patent No. 5,019,052, the entire content of which is hereby incorporated by reference. Briefly, U.S. Patent No. 5,019,052 concerns a bipartite injector device formed of an outer shell having a closed end with a bore leading to an external spout, and an open end to receive the stoppered end of a medicament vial, and an inner sleeve having a cantilever end connectable to the shell closed end, and a free end with a socket connectable to the vial stopper, plus a hollow needle mountable at one end by the sleeve to communicate with the bore and to dispose its other pointed end in the socket to penetrate the stopper to communicate with the vial, the shell and sleeve having connector formations for coaxial snap fit cantilever interlocking and fluid tight flow connection of the parts. U.S. Patent No. 5,060,704, the entire content of which is also hereby incorporated by reference, relates to a suction transfer assembly of a vial having a chamber filled with a medicament liquid, such as a hazardous liquid, and closed by a stopper on which the vial is longitudinally slidable, and a flow path containing an adapter connectable on one end to the vial by a hollow needle that penetrates the stopper, and on the other end to a suction operating dispenser device, e.g. a syringe, lockably connectable to the adapter at a check valve in the flow path to transfer liquid from the vial to the device, with simultaneous compensating vial movement relative to the stopper under external atmospheric pressure to reduce the chamber volume by an amount equal to the liquid transferred, yet preventing leakage from the adapter on disconnecting the device. Although transfer and injector constructions are known, as noted in the above-mentioned patents, the prior art does not allow for direct injection of hazardous fluids. U.S. Patent No. 5,060,704 is a transfer device which allows for suction of the medicament from the vial to a syringe type device for subsequent administration via an intermediary adapter, while U.S. Patent No. 5,019,052 only allows for injection of non-hazardous fluids since the design does not incorporate any safety features to prevent leakage or drug exposure. Accordingly, there is a long felt need in the art for an injector device capable of the direct administration of a hazardous fluid
SUMMARY OF THE INVENTION
The present invention may effectively contains a hazardous fluid within the internal chamber of an injector device until released upon probe activation, thereby protecting the health care provider from hazardous fluid exposure. Additionally, the present invention allows for direct administration of the hazardous fluid, and therefore is no longer merely a transfer device.
According to a preferred embodiment, the present invention overcomes the disadvantages of the prior art by providing a probe-activated medicament bipartite injector device formed of an outer shell and inner sleeve connected in cantilever manner to the shell for fluid tight flow of a medicament between a vial connected to one end of the device and a mechanically activated, normally closed valve at the other end of the device. The valve end of the device may in turn be connected to a separate charging or dispensing device. According to a further preferred embodiment of the invention, an injector device is advantageously provided which comprises a longitudinal hollow outer shell, a separate cylindrical inner sleeve, and a normally closed check valve that defines a fluid path of the device. The outer shell preferably has a front closed end, a rear open end and a cylindrical inner wall forming an interior to receive coaxially through the open end, and guide for movement relative thereto, a cylindrical medicament vial closed by a penetrable stopper. A central hub extends through the closed end from an external spout to a circular seat in the shell interior and has a bore extending from the spout to the seat. The shell also preferably has a radially inwardly directed circular constriction ring on the inner wall adjacent the closed end and a radially inwardly facing circular locking groove defined axially on the wall between the ring and closed end.
The inner sleeve preferably has a front cantilever mounting end with a radially outwardly directed flange terminating peripherally in a circular compression rim, a central needle mounting portion, and a rear free end having a cylindrical socket to connect the vial stopper stationarily thereto, and includes a hollow needle with a front circular collar flange and rear pointed end.
The inner sleeve is preferably sized for location in the outer shell sufficiently radially inwardly of the inner wall to permit insertion of the vial therebetween, and the rim is sized for compression displacement through the ring and snap fit locking in the groove to mount the sleeve coaxially in the shell with the sleeve front end in cantilever stationary connection with the shell closed end. The needle mounting portion is preferably arranged to mount the needle coaxially and in fluid tight condition relative to the bore and sleeve such that the needle pointed end is disposed coaxially in the socket to penetrate the stopper for protected fluid tight flow between the vial and nozzle through the needle and bore. The shell has a radial front wall forming its closed end, and the sleeve flange is preferably sized and arranged to abut that wall when the rim and groove are in locking engagement. The injector device of the present invention is thus preferably formed of an outer shell having a closed front end with a bore and an internal seat which seals with a mechanical probe-openable and self-closing check valve and an inner sleeve having a front end connection to the outer shell front end for a snap fit cantilever locking therewith to provide a tight coaxial and concentric arrangement of parts, and a rear free end opened to receive the stoppered end of a medicament vial with a socket connectable to the vial stopper plus a hollow needle having a front collar flange mountable via the sleeve and its rear pointed end for penetration of the stopper. The components of the present invention thus communicate to form a fluid path so that on locking a counterpart nozzle of an accessory device to the check valve nozzle, the probe or mechanical contact portion of the accessory device opens the check valve for transfer and direct administration of liquid from the vial through the device. Hazardous liquids may thereby be directly injected without safety concerns regarding leakage. Still further, a preferred embodiment of the present invention provides an injector assembly for transfer and direct administration of fluid from a vial. The injector assembly comprises an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, the check valve comprising a mechanical contact probe- openable and self-closing valve and an internal flow path extending therethrough. The injector assembly further comprises an accessory device including an adapter attachable to the closed front end of the injector device, the adapter including a rear end having a contact portion arranged for flow connection with the nozzle of the injector device and for opening the check valve, a forward end for connection to a desired apparatus, and an internal flow path extending therethrough. The injector assembly thereby defines a fluid path such that on attaching the adapter to the nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into the accessory device for delivery to the desired apparatus. A further preferred embodiment of an injector assembly according to the present invention comprises a vial forming an enclosed longitudinal chamber for holding a medicament liquid and having an open end closed by a penetrable stopper, the vial being slidable longitudinally relative to the stopper and the stopper slidably sealing the liquid in the chamber in any position of vial sliding movement, the stopper having fastening means facing the vial open end; an injector device having a rear open end for receiving the medicament fluid containing vial, a rearwardly facing hollow needle with a pointed tip being insertable into the vial open end to fasten the injector device to the vial and to penetrate the stopper by the needle, a front closed end including a nozzle and a check valve, said check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough; and an accessory device comprising an adapter attachable to the closed front end of the injector device, the adapter including a rear end having a contact portion arranged for flow connection with the nozzle of the injector device and for opening the check valve, a forward end for connection to a desired apparatus, and an internal flow path extending therethrough. The injector assembly thereby defines a fluid path such that on attaching the adapter to the nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into the accessory device for delivery to the desired apparatus. Moreover, a further preferred embodiment of the present invention is directed to an injector assembly for transfer and direct administration of fluid from a vial. The injector assembly comprises an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, the check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough, the front closed end of the injector device being configured for cooperation with a contact portion arranged for flow connection with the nozzle of the injector device and for opening the check valve. The injector assembly thereby defines a fluid path such that when the front closed end cooperates with the contact portion, the check valve opens for transfer and direct administration of fluid from the vial and through the injector device.
BRIEF DESCRIPTION OF THE DRAWINGS Other objects of the invention will become apparent from the specification within and accompanying drawings, in which:
FIG. 1 is a schematic sectional view of a preferred embodiment of the injector device showing the stoppered vial and injector in unassembled condition.
FIG. 2 is an enlarged partial view of the FIG. 1 device, showing the snap fitting of the sleeve to the shell and showing the mechanically activated valve assembly in a closed position.
FIG. 3 is an enlarged partial view of the FIG. 1 device, showing the snap fitting of the sleeve to the shell and showing the mechanically activated valve assembly in an open position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
A probe-activated medicament injector assembly is shown generally in Fig. 1 by reference numeral 1. Referring also to Figs. 2 and 3, injector assembly 1 includes an injector device 2, which operates with an accessory device comprising an adapter 48, and a conventional cylindrical medicament liquid containing receiving vial 4, such as a plunger vial, at the rear end of injector device 2.
The injector device 2 has a longitudinal, preferably cylindrical, hollow outer shell 26 and a cylindrical inner sleeve 27, a centrally mounted needle 42, and a check valve 5, which is described in detail below. Shell 26 has a preferably circular rear open end 24 and a front end 76 including a bore 19, a circular valve seat 18 and a sealing ring 16 which seats check valve 5.
The rear open end 24 of shell 26 preferably mates with a rear protective cap 28 to maintain sterility of the injector device via mechanical interference of an outer shell cap circumferencial rib 29 and a protective cap groove 23. Similarly, the front end of nozzle 11 may be provided with a protective valve cap 6 to maintain sterility until the assembly is ready to be used (Figs. 1 and 2). The protective valve cap 6 may then be removed and an adapter 48, such as the illustrated male-male luer coupler, may be connected to the front end of device 2 (Fig. 3).
The shell 26 outwardly confines the nozzle 11 at its closed end to connect thereto a separate infusion or dispensing device (not shown) for fluid tight flow between the vial 4 and an administration device via the needle 42, nozzle 11, and male luer coupler accessory device 48. The nozzle 11 may have a luer lock connector 10 mating the male luer coupler 48 via a screw thread counterpart connector 81 for a releasable interconnection. The interconnection thus formed is similar to a screw and nut mechanism and will not disengage during normal use.
The outer edge of rear end 74 of inner sleeve 27 may have a circumferen- tial counterpart formation of ratchets 40 and associated bosses 41 at the outer end of threads 39 in a socket 75 which are arranged to coact with the stopper recess 63 and bosses 64 for a locking grip therebetween when the injector device 2 is rotated onto stopper 56 to achieve their interconnection and the penetration of the stopper seal 57 by the needle tip 47. As the inner sleeve socket threads 39 reach full rotational engagement with the stopper threads 58, the inner sleeve ratchets 40 and bosses 41 engage the stopper recess 63 and bosses 64 to snap-lock in the stopper recess 63, such that the respective ratchets, bosses and recesses form coacting separation inhibiting means to prevent separation of the injector device 2 from the stopper 56. The cylindrical inner wall 25 of the outer shell 26 forms an interior cavity to coaxially receive, via end 24, the guide vial 4 for relative longitudinal and rotational movement. The open end 69 of the vial 4 is closed by a shiftable cylindrical, needle penetrable, stopper 56 having ridges 62 to seal the contents thereof, e.g., a medicament or liquid L. A removable cap 55 may also be provided prior to use.
The inner wall 25 has a radially inwardly directed circular constriction ring
20 adjacent the front end and a radially inwardly facing circular locking groove 21 defined axially thereon between ring 20 and the radial front wall forming closed front end 76. Ring 20 is preferably formed as a hollow, frustoconical insert ramp
20a (preferably having an angle of about 30 degrees), a hollow cylindrical center span 20b, and an opposed hollow, frustoconical lock ramp 20c (preferably having an angle of about 45 degrees). The inner wall 25, the ring 20, the groove 21 and the sealing ring 16 are preferably circular in cross section, concentric and coaxial, and the bore 19 preferably extends along the center axis of the shell 26.
The rear end 24 preferably has lateral flanges 22 formed as finger grips to aid in the handling of injector device 2 during use, and a groove formation 23 to receive an aseptic friction fit closure cap 28 to keep the injector device 2 sterile prior to connection and use with the vial 4. A similar cap 6 may protect the spout of nozzle 11 at the front end 76.
The inner sleeve 27 has a front cantilever mounting end 31 and a rear free end 74. The front end 31 has a radially outwardly directed circular flange 32 terminating peripherally in a circular compression rim 77, sized and arranged to coact with the ring 20 and the groove 21 to thereby connect the front end 31 of the sleeve 27 in cantilever manner to the front end 76 of the shell 26. The front end
31 also has an annular excavation and a forwardly facing central recess 33 defining a female luer and communicating via central internal passage 78 with a rearwardly facing central extension 38 which defines a male luer. As shown in
Fig. 1, the passage 78 preferably tapers from the recess 33 to the extension 38. Under flange space 79 defines a concentric compression compensation space to aid local compression displacement of the rim 77 through the ring 20 for snap fit locking in the groove 21. The recess 33 is sized and arranged to receive the valve luer 12 of the valve 5 in fluid tight condition and to thus communicate the bore 13 with the passage 78. The remainder of the inner sleeve 27 interior at the extension 38 forms an annular space 36 within rearward cylindrical extension 38 having internal luer lock threads 37. A hollow needle 42 is disposed in a cylindrical extension 80 with its externally threaded front circular collar flange 45 (which may be tapered) mounted in fluid tight condition on central extension 38 via the internal threads 37 on extension 38 to communicate with the passage 78. The needle is preferably a conventional metal needle, such as a standard, regular bevel (B-D I.V. 166A. times.11/2"), although other needles could of course also be used. This mounting also positions the rear pointed end of the needle 42 coaxially in a socket 75, in the rear end 74 at the remote portion of the sleeve extension 80, and centrally of the socket internal threads 39, within the sleeve outer wall 71.
The rim 77, recess 33, extension 38, sleeve extension 80, socket 75 and outer wall 71 are preferably circular in cross section, concentric and coaxial, and the passage 78 preferably extends along the center axis of the sleeve 27.
The recess 33, central extension 38, socket 75 and cylindrical extension 80 provide a central needle mounting portion between rim 77 and socket 75, so that when rim 77 firmly locks in the groove 21, the recess 33 automatically firmly seats against valve luer 12, and the threads 37 selectively adjustably engage the threaded collar flange 36 to automatically locate the needle 42 to seat the flange 45 automatically firmly against the extension 38, for fluid tight flow between the needle 42 and the nozzle 11 via the passage 78 and the bore 13.
According to one embodiment of the present invention, the needle mounting portion 85 has a forwardly facing central circular recess 33 at the sleeve front end, a rearwardly facing central circular extension 36 and a passage 78 from the recess to the extension, the recess, extension and rim 86 being coaxial. The collar flange 45 is arranged for coaxial mounting on the extension, and the recess is arranged to receive the seat 46 coaxially. The needle mounting portion has connector means 37 and the collar flange has counterpart connector means 87 to connect the needle to the sleeve at the extension.
Alternatively, the needle mounting portion has a central circular hollow recess formation with a circular shoulder, the formation, shoulder and rim being coaxial, and the formation and shoulder sized to receive and engage the collar flange with the formation peripherally embracing it and the shoulder axially locating it to mount it on the seat. The recess formation includes a forwardly facing larger diameter central circular neck recess at the sleeve front end outwardly bounded by a forward thin wall neck extending rearwardly from the sleeve flange, and a rearwardly facing smaller diameter central circular shank recess outwardly bounded by a thick wall shank extending rearwardly from, and separated by the shoulder from, the neck. The shoulder is arranged to locate the collar flange rearwardly of the forward-most neck extent, and the neck is sized to aid the rim compression displacement through the ring to lock in the groove. Matching tapers for the valve luer 12, recess 33, extension 38 and the collar flange 45 and preset positioning of the needle 42 per the threaded collar flange 45 and threads 37, assure fluid tight connection of the pertinent needle 42 and sleeve 27, as rim 77, ring 20 and groove 21 are sized, located and matched for tight snap fit connection of the sleeve 27 to the shell 26. Preferably, the shell and sleeve are plastic for snap fit cantilever connection to form the injector device, the needle is preferably metal, and the check valve is also preferably plastic. The shell 26 and sleeve 27 are most preferably formed as injection molded plastic pieces, to promote their snap fit cantilever locking and fluid tight connection, and enable use of low cost dies of simple design, yet of precise dimension and shape, to fabricate these two pieces with conforming parts accurately mating to achieve their desired concentric and coaxial alignment relationship that is essential to proper alignment with the vial 4 during use. For example, the shell 26 and sleeve 27 may be sized for different volume dosages (for example, 10 mL to 50 mL dosages) with concordantly sized vials. Broadly, the shell and the sleeve have coacting connector formations for snap fit cantilever interlocking, and the check valve and the shell have coacting connector formations for press-fit assembly.
The above-described parts of the injector device 2 are precisely formed, sized, shaped and arranged, relative to each other to maintain their snap fit cantilever interconnection, with their parts in accurate centered alignment, and especially with the given, i.e. cantilever mounted, standard needle centered relative to the sleeve socket, which centering is advantageous for vial stopper center puncturing without misalignment or other mishap regarding safety of the patient and the user of the device.
Moreover, since in injector device 2 the ring and groove are formed on the shell, and the flange and rim are formed on the sleeve, as integral parts, they will be more precisely centered and axially positioned, e.g. to tolerances controlled by the injection molding process, for more accurate coaxial alignment of the needle mounted thereon with the stopper entrance of the vial, to achieve easy, rapid and safe screwing of the stopper into the socket without needle and stopper bore misalignment.
As shown in Fig. 1, the internal threads 39 in socket 75 connect the stopper 56 of vial 4 stationarily thereto when open end 69 is screwed therein via stopper external threads 58. This causes the pointed end of needle 42 to align coaxially with the stopper entrance 70, to penetrate the stopper seal 57, to enter stopper bore 60 and establish fluid communication with vial medicament L. By grasping the flanges 22, the vial 4 may be pushed between shell inner wall 25 and sleeve outer wall 71, preferably having circumferentially spaced longitudinal guide ribs 72 (shown in Fig. 2) along the vial guideway 73.
The ribs 72 selectively radially size the annular gap of guideway 73, i.e. between the outer radius of sleeve ribs 72 and inner radius of shell wall 25, to conform to the vial 4 radial dimensions, while conserving material and lightening the structure without detracting from the robust structural integrity of sleeve 27, in that the circumferential arc portions between ribs 72 constitute excavated spaces on outer wall 71. The ribs 72 thus inhibit excess angular movement between the shell 26, sleeve 27 and vial 4, and misalignment between the needle 42 and stopper entrance 70. The ribs 72 are removed from Figs. 1 and 3 for clarity of illustration.
When a vial 4 holding a medicament fluid is inserted in the guideway 73 and the stopper 56 is screwed into the socket 75 to cause the needle 42 to enter stopper entrance 70 and puncture the seal 57, the vial 4 may be pushed further into injector device 2 while the stopper 56 is stationarily connected to the socket 75, to force medicament L from the filled rear half of the vial 4 via needle 42, passage 78 and bore 13 to nozzle 11, when for example it is connected to a separate dispensing device.
In injector device 2, when the vial is threaded into the socket, the pushing and rotational movement of the vial develops torque which is countered by a friction force urging the rim 77 against the groove 21 and the flange 32 against the radial wall, and as an added measure the anti-rotation features or teeth 65 of shell 26 interferes with ribs 66 of sleeve 27 to inhibit rotational movement of sleeve 27 within shell 26. The contact between sealing ring 16 and seat 18 against valve wall 15 also develops friction to inhibit rotation of shell 26, sleeve 27, and valve 5.
The various parts are desirably sized to position the needle pointed end coaxially in the socket slightly inwardly of the sleeve open end sufficiently to protect the needle from unintended human contact thereat. Due to the precise fluid tight fit of the associated internal parts of the injector device 2, the flow path from the vial through the needle via passage 78 and bore 13 in device 2 is completely protected and entirely free of dead spaces. The check valve 5 and male luer coupler 48 facilitate use and prevent accidental leaks and exposure to hazardous medicaments, as described in detail below. The injector device 2 may be provided as a one-time use discardable item and the injector device may be fabricated from conventional materials and components and assembled in simple and inexpensive manner.
The check valve 5 faces the hollow nozzle 11 which defines the front terminus of flow path 14. Check valve 5 is preferably a mechanical contact probe-openable and self-closing valve, as described in the afore-mentioned U.S. Patent No. 5,060,704. Valve 5 is preferably formed of a resilient diaphragm 8 having a forwardly facing hollow tubular nose 7 provided with liquid inflow apertures 67, and it is situated in a valve chamber 68 with an outer edge perimeter of diaphragm 8 rigidly seated on the interior chamber wall 9. As illustrated in FIG. 2, check valve 5 is in a closed position.
Nose 7 defines a valve plunger which projects into the internal bore of nozzle 11 while diaphragm 8 seats sealingly against the adjacent wall 9 of valve chamber 68 when valve 5 is in a normally self-closed position. On inserting a mechanical contact probe into the bore of nozzle 11, however, nose 7 is contacted by the probe and urged inwardly to lift diaphragm 8 from its seated position and thereby open valve 5.
More particularly, in a preferred embodiment of the present invention, the accessory device comprises a male-male luer coupler or adapter 48 including a first male luer 51 disposed on a front end 53 and second male luer 51 on a back end 54 of the adapter 48. A rear extension 54a of the rear end 54 thus defines a probe, or contact portion, which, when inserted into the nozzle 11 (preferably comprising a female luer), engages the nose or valve plunger 7 and displaces the nose 7 rearwardly a sufficient distance such that the spaced fingers 7a, 7b of the nose 7 extend past the chamber wall 9 and thereby unseat the diaphragm 8 from its seated position against the wall 9. In so doing, fluid communication is established throughout the injector assembly 1.
Nozzle 11 which preferably defines a female luer, valve 5, diaphragm 8, nose 7, apertures 67, chamber 68 and a luer lock 10, may be formed as a separate commercial add-on valve assembly, such as, for example, a valve assembly of the type shown in U.S. Pat. No. 4,535,820, the entire contents of which are hereby incorporated by reference. The valve assembly would then be mounted by connection of valve male luer 12 and the inner sleeve female luer which includes an annular valve seat or recess 34 in the inner sleeve 27 at front end 31, and a hollow annular extension 33, with the valve bore 13 within the central extension 33 communicating with the inner end of needle 42 at the interface to form a part of the flow path 14 in injector device 2.
The various components of the injector assembly 1 of the present invention thus communicate to form a fluid path 78, 14 so that on locking a counterpart nozzle 51 of the accessory device 48 to the check valve nozzle 11, the probe or mechanical contact portion, such as the rear extension 54a of the accessory device 48, opens the check valve 5 for transfer and direct administration of fluid from the vial 4 through the injector device 2 and into a further apparatus (not shown) connectable to the forward end of the accessory device 48. The present invention thus allows for hazardous medicaments or other fluids to be directly injected while minimizing the risk of leakage or endangering the lives of hospital or other health care providers.
While the present invention has been described with preferred embodiments, it is to be understood that variations and modifications may be resorted to as will be apparent to those skilled in the art. Such variations and modifications are to be considered within the purview and the scope of the present invention.

Claims

1. An injector assembly for transfer and direct administration of fluid from a vial, said injector assembly comprising: an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, said check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough; an accessory device comprising an adapter attachable to said closed front end of said injector device, said adapter including a rear end having a contact portion arranged for flow connection with the nozzle of said injector device and for opening the check valve, a forward end for connection to a desired apparatus, and an internal flow path extending therethrough, wherein said injector assembly thereby defines a fluid path such that on attaching said adapter to said nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into said accessory device for delivery to the desired apparatus.
2. The injector assembly of claim 1 , wherein said injector device comprises: a longitudinal hollow outer shell having a central axis and defining the front closed end and the rear open end, a cylindrical inner wall forming an interior adapted to receive coaxially through the open end and guide for movement relative thereto the medicament vial closed by a penetrable stopper, a radially inwardly directed circular constriction ring on the inner wall adjacent the closed end and a radially inwardly facing circular locking groove defined axially on the inner wall between the ring and a radial front wall forming the closed end, the inner wall, ring, and groove being coaxial relative to the shell central axis, a cylindrical inner sleeve having a central axis and including a front cantilever mounting end having a radially outwardly directed flange terminating peripherally in a circular compression rim, a central needle mounting portion and a rear free end having a cylindrical connection socket adapted to connect the stopper thereat, and a hollow needle having a front circular collar flange and a rear pointed end, the sleeve, rim, needle mounting portion and socket being coaxial relative to the sleeve central axis, wherein the sleeve is sized for location in the shell sufficiently radially inwardly of the inner wall to permit insertion of the vial therebetween, the compression rim being sized for compression displacement through the ring and snap fit locking in the groove to mount the inner sleeve coaxially in the outer shell with the inner sleeve front end in cantilever stationary connection with the outer shell closed end, the inner sleeve flange being sized and arranged to abut stationarily against the radial front wall forming the outer shell closed end when the rim is in snap fit locking engagement with the groove, and the needle mounting portion being arranged to mount the needle coaxially and in fluid tight condition and to dispose the needle pointed end coaxially in the socket for penetrating the stopper for protected fluid tight flow between the vial and nozzle through the needle.
3. The injector assembly of claim 2, wherein the shell and sleeve are formed of plastic for snap fit cantilever connection.
4. The injector assembly of claim 3, wherein the shell and sleeve are formed as injection molded pieces.
5. The injector assembly of claim 2 wherein the needle is metal.
6. The injector assembly of claim 1, wherein the adapter includes a counterpart nozzle for locking engagement with the nozzle of the injector device.
7. The injector assembly of claim 6, wherein the counterpart nozzle is a male luer lock connector and the nozzle of the injector device is a female luer lock connector.
8. The injector assembly of claim 1, wherein the injector device further includes at least one removable cap for maintaining sterility thereof.
9. The injector assembly of claim 1, wherein said mechanical contact probe-openable and self-closing check valve comprises a resilient diaphragm and a valve plunger.
10. The injector assembly of claim 9, wherein said contact portion of said adapter engages the valve plunger of said check valve and displaces the valve plunger rearwardly a sufficient distance such that the valve plunger unseats the resilient diaphragm from its seated position again an interior wall of a valve chamber and thereby permits fluid communication from the injector device to the accessory device.
11. The injector assembly of claim 9, wherein the valve plunger includes a plurality of spaced fingers.
12. An injector assembly for transfer and direct administration of fluid from a vial, said injector assembly comprising: a vial forming an enclosed longitudinal chamber for holding a medicament liquid and having an open end closed by a penetrable stopper, the vial being slidable longitudinally relative to the stopper and the stopper slidably sealing the liquid in the chamber in any position of vial sliding movement, the stopper having fastening means facing the vial open end; an injector device having a rear open end for receiving the medicament fluid containing vial, a rearwardly facing hollow needle with a pointed tip being insertable into the vial open end to fasten the injector device to the vial and to penetrate the stopper by the needle, a front closed end including a nozzle and a check valve, said check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough; an accessory device comprising an adapter attachable to said closed front end of said injector device, said adapter including a rear end having a contact portion arranged for flow connection with the nozzle of said injector device and for opening the check valve, a forward end for connection to a desired apparatus, and an internal flow path extending therethrough, wherein said injector assembly thereby defines a fluid path such that on attaching said adapter to said nozzle, the contact portion opens the check valve for transfer and direct administration of fluid from the vial, through the injector device and into said accessory device for delivery to the desired apparatus.
13. The injector assembly of claim 12, wherein said injector device comprises a longitudinal hollow outer shell and a cylindrical inner sleeve.
14. The injector assembly of claim 13, wherein said outer shell defines said front closed end and said rear open end, said outer shell further including a central axis and a cylindrical inner wall forming an interior adapted to receive coaxially through the open end and guide for movement relative thereto the medicament vial closed by the penetrable stopper.
15. The injector assembly of claim 14, wherein said outer shell further includes a radially inwardly directed circular constriction ring on the inner wall adjacent the closed end and a radially inwardly facing circular locking groove defined axially on the inner wall between the ring and a radial front wall forming the closed end, the inner wall, ring, and groove being coaxial relative to the shell central axis.
16. The injector assembly of claim 15, wherein said inner sleeve includes a front cantilever mounting end having a radially outwardly directed flange terminating peripherally in a circular compression rim, a central needle mounting portion and a rear free end having a cylindrical connection socket adapted to connect the stopper thereat, the sleeve, rim, needle mounting portion and socket being coaxial relative to the sleeve central axis.
17. The injector assembly of claim 16, wherein said inner sleeve is sized for location in said outer shell sufficiently radially inwardly of the inner wall to permit insertion of the vial therebetween.
18. The injector assembly of claim 17, wherein the compression rim is sized for compression displacement through the ring and snap fit locking in the groove to mount the inner sleeve coaxially in the outer shell with the inner sleeve front end in cantilever stationary connection with the outer shell closed end, the inner sleeve flange being sized and arranged to abut stationarily against the radial front wall forming the outer shell closed end when the rim is in snap fit locking engagement with the groove, and the needle mounting portion being arranged to mount the needle coaxially and in fluid tight condition and to dispose the needle pointed end coaxially in the socket for penetrating the stopper for protected fluid tight flow between the vial and nozzle through the needle.
19. The injector assembly of claim 13, wherein the shell and sleeve are formed of plastic for snap fit cantilever connection.
20. The injector assembly of claim 19, wherein the shell and sleeve are formed as injection molded pieces.
21. The inj ector assembly of claim 13 , wherein the needle is metal.
22. The injector assembly of claim 12, wherein the adapter includes a counterpart nozzle for locking engagement with the nozzle of the injector device.
23. The injector assembly of claim 22, wherein the counterpart nozzle is a male luer lock connector and the nozzle of the injector device is a female luer lock connector.
24. The injector assembly of claim 12, wherein the injector device further includes at least one removable cap for maintaining sterility thereof.
25. The injector assembly of claim 12, wherein said mechanical contact probe-openable and self-closing check valve comprises a resilient diaphragm and a valve plunger.
26. The injector assembly of claim 25, wherein said contact portion of said adapter engages the valve plunger of said check valve and displaces the valve plunger rearwardly a sufficient distance such that the valve plunger unseats the resilient diaphragm from its seated position again an interior wall of a valve chamber and thereby permits fluid communication from the injector device to the accessory device.
27. The injector assembly of claim 25, wherein the valve plunger includes a plurality of spaced fingers.
28. An injector assembly for transfer and direct administration of fluid from a vial, said injector assembly comprising: an injector device having a rear open end for receiving a medicament fluid containing vial, a front closed end including a nozzle and a check valve, said check valve comprising a mechanical contact probe-openable and self-closing valve, and an internal flow path extending therethrough, said front closed end of said injector device being configured for cooperation with a contact portion arranged for flow connection with the nozzle of said injector device and for opening the check valve; wherein said injector assembly thereby defines a fluid path such that when said front closed end cooperates with the contact portion, said check valve opens for transfer and direct administration of fluid from the vial and through the injector device.
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US10569018B2 (en) 2012-04-09 2020-02-25 Becton, Dickinson And Company Vial dosing systems and methods
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AU2003217677A8 (en) 2003-09-09
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