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WO2008146021A1 - Injecteur automatique - Google Patents

Injecteur automatique Download PDF

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Publication number
WO2008146021A1
WO2008146021A1 PCT/GB2008/001871 GB2008001871W WO2008146021A1 WO 2008146021 A1 WO2008146021 A1 WO 2008146021A1 GB 2008001871 W GB2008001871 W GB 2008001871W WO 2008146021 A1 WO2008146021 A1 WO 2008146021A1
Authority
WO
WIPO (PCT)
Prior art keywords
auto
injector according
colour
syringe
needle
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/GB2008/001871
Other languages
English (en)
Inventor
Martin John Mcloughlin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
UCB SA
Original Assignee
UCB SA
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 UCB SA filed Critical UCB SA
Publication of WO2008146021A1 publication Critical patent/WO2008146021A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/27—General characteristics of the apparatus preventing use
    • A61M2205/276—General characteristics of the apparatus preventing use preventing unwanted use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3633—General characteristics of the apparatus related to heating or cooling thermally insulated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/60—General characteristics of the apparatus with identification means
    • A61M2205/6063—Optical identification systems
    • A61M2205/6081—Colour codes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the present invention relates to an auto-injector for receipt of a syringe that is suitable for use in the injected delivery of a drug formulation to a patient.
  • syringes for the delivery of injectable liquid drug formulation to a patient.
  • Traditional syringes rely on puncturing of the patient's skin by a hollow needle through which the injectable drug (e.g. in solution or suspension form) is delivered to the muscle or tissue of the patient.
  • auto-injectors for use with syringes.
  • Such auto-injectors typically comprise a body for housing the syringe and an actuating mechanism, which is triggered in use, to allow for delivery of the liquid drug formulation from the syringe.
  • Certain liquid drug formulations arranged for delivery by means of an auto- injector and syringe require cool storage (e.g. in a refrigerator) to prevent degradation of the drug.
  • Such liquid drug formulations include for example, those based on therapeutic biologic type drug actives.
  • the viscosity of such liquid drug formulations is however, temperature dependent. Often the refrigerated liquid drug formulation is too viscous to be delivered effectively by the syringe. Normal use therefore requires that the auto-injector and syringe containing liquid drug formulation be removed from the refrigerator and allowed to warm up (e.g. typically to room temperature) before the patient injects. Such warming up of the liquid drug formulation results in the viscosity thereof decreasing such that effective delivery thereof from the syringe is better enabled.
  • an auto-injector device which includes a temperature indicator comprising materials, which change colour over the desired temperature range.
  • the temperature indicator might indicate one colour for an insufficiently warmed up device, which is not suitable for use, and another colour for a sufficiently warmed up device, which is now suitable for use.
  • the temperature indicator may be provided to an indicium such that the indicium is blocked off (or in alternatives, revealed) for an insufficiently warmed up device, but revealed (or in alternatives, blocked off) for a sufficiently warmed up device.
  • an auto- injector comprising
  • a housing arranged for receipt of a syringe containing a liquid drug formulation
  • an actuating mechanism for actuating said syringe to deliver said liquid formulation to a patient
  • a visual indicator comprising a colour change material that defines a first colour state below a transition temperature and a second colour state above said transition temperature.
  • an auto-injector device that is arranged for use with a syringe that contains a liquid drug formulation.
  • the syringe is arranged to be suitable for use in the injected delivery of the liquid drug formulation to a patient.
  • the auto-injector comprises a housing that is arranged for receipt of the syringe and is therefore typically sized and shaped for this purpose.
  • the syringe suitably comprises a barrel for holding a volume of the liquid drug formulation; a needle at one end of the barrel; and a plunger that is axially movable within the barrel.
  • the plunger is movable axially within the barrel so as to enable the liquid drug formulation to be expelled from the barrel and thence through the needle for injection into the patient.
  • the barrel is selected such as to define a barrel chamber for containing a suitable volume of the liquid drug formulation.
  • that suitable volume is selected to correspond to a single dose of the drug formulation to be delivered to the patient.
  • delivery of that single dose involves expelling all of the liquid drug formulation contents of the barrel chamber through the needle for injection into the patient.
  • the needle defines a needle bore, which is most typically of circular cross- section and of selected bore diameter. It may be appreciated that in aspects, the bore diameter may affect the force required to expel the liquid drug formulation through the needle and also the velocity at which the liquid drug formulation is expelled.
  • the selected needle bore may also, in aspects affect the degree of patient discomfort during injection. Smaller bore diameters, typically provide more patient comfort, whereas larger bore diameters enable more rapid / lower force delivery of the liquid through the needle. A compromise is therefore needed in selecting needle bore to provide acceptable patient comfort and liquid delivery through the needle characteristics.
  • Examples of typical needles that are suitable for use therein include 12.5mm ("half inch”) long thin wall needles of grade 23G, 25G or 27G. These have a needle bore of from about 0.2 to 0.4mm such as from 0.25 to 0.35mm.
  • the housing of the auto-injector is typically shaped to define a housing cavity within which the syringe is receivable.
  • the housing cavity may be further shaped with any manner of grooves, indentations or other shaping or surface details to define a 'lock and key' relationship between the housing and the syringe.
  • Colour guides, arrows and any other surface markings may also be employed.
  • the housing of the auto-injector is provided with a barrel receiving part for receiving the barrel of the syringe; a plunger receiving part for receiving the plunger of the syringe; and a needle receiving part for receiving the needle of the syringe.
  • the plunger receiving part of the housing allows the plunger to be received thereby and for the plunger to be movable (e.g. axially) therein from a first position, in which it is somewhat withdrawn from the barrel to a second position, in which it is moved somewhat into the barrel.
  • the needle receiving part of the auto-injector housing includes a needle delivery aperture through which the needle may protrude from the housing, for example during expelling of the liquid drug formulation through the needle for delivery to the patient.
  • the auto-injector is arranged to allow for actuation of the syringe.
  • the auto-injector is provided with an actuating mechanism for actuating the syringe (e.g. typically by plunging the plunger axially into the barrel thereof) to deliver the liquid formulation to the patient.
  • the actuating mechanism typically includes an energy store for storing energy that can then be released to allow for actuation of the syringe.
  • the energy store comprises a mechanical energy store such as a spring (e.g. a compression or torsion spring).
  • the energy store may be provided by a container of compressed liquid or gas propellant that on release provides a source of jet energy propulsion.
  • the energy store is suitably able to exert a force of up to 6ON on the plunger of the syringe.
  • the energy store is a compression spring the force exerted typically varies over the actuation profile such as from a range of 60 to 4ON at the start of actuation to from 40 to 2ON at the end of the actuation profile.
  • the energy store is a compressed liquid or gas propellant a more constant force is typically exerted over the actuation profile.
  • actuation of the actuating mechanism is responsive to a trigger (e.g. a user-actuable trigger).
  • a trigger e.g. a user-actuable trigger
  • the trigger comprises a button, switch or lever arrangement.
  • a reset mechanism for resetting the firing mechanism after actuation thereof.
  • the reset mechanism may for example, comprise a spring, motor, mechanical arrangement or a reset coupling.
  • the housing is arranged such that the needle receiving part thereof allows for the needle of the syringe to be axially moveable therein from a first (i.e. rest) position in which the needle is wholly housed by the needle receiving part to a second (i.e. use) position in which at least the tip of the needle protrudes from that needle receiving part of the housing.
  • the housing includes biasing means (e.g. a spring) arranged such that the needle is normally biased towards the first (i.e. rest) position, wherein such biasing means are overcome during the actuation of the syringe by the actuating mechanism to allow for movement of the needle to the second (i.e. use) position.
  • a needle retraction mechanism is provided for retracting the needle back into the needle receiving part of the housing after the injection procedure, that is to say retracting the needle from the second (i.e. use) position to the first (i.e. rest) position.
  • the retraction mechanism may for example, comprise a spring, motor, mechanical arrangement or a reset coupling.
  • Representative auto-injectors that may be modified to incorporate a visual indicator in accord with the present invention include those described in United States Patent No.s US-A-4,553,962; US-A-4,378,015; US-A-5,304,128 and PCT Patent Application No.s WO99/22790 (Elan Corporation); WO00/09186 (Mediject Corporation); and WO2005/070.481 (The Medical House PLC) all of which are incorporated herein by reference.
  • the auto-injector is provided with child-resistant features to prevent undesirable actuation of the actuating mechanism by a young child.
  • the auto-injector further comprises a visual indicator.
  • the visual indicator is suitably arranged to provide the user with a visual indication of the temperature state of the auto-injector, and particularly of the syringe and its contents (i.e. the liquid drug formulation), which at least allows the user to differentiate between a 'too cold to use' state and a 'sufficiently warm to use' state.
  • the visual indicator may be provided to the auto-injector by any suitable means.
  • a region of the housing and/or of the syringe is provided with the visual indicator.
  • the visual indicator is provided as a coating (e.g. by painting or spraying on) to the region of the housing and/or of the syringe.
  • the visual indicator is provided to a label, which is provided to the region of the housing and/or of the syringe.
  • the label is comprised of a plastic polymer or cellulosic (e.g. paper) material.
  • the label is provided with an adhesive layer for adhesive application to the region of the housing and/or of the syringe.
  • an insulating layer is provided to the visual indicator.
  • the insulating layer is typically provided as an outer layer to provide an insulating barrier between the visual indicator and temperature stimuli, which are external to (e.g. the housing and/or the syringe of) the auto-injector.
  • the visual indicator will provide an indication that is representative of the temperature state of (e.g. the housing and/or the syringe of) the auto-injector rather than of any adjacent external stimuli.
  • the insulating layer acts as a barrier to any heat transfer from the fingers and/or hand of the user, which might otherwise distort the temperature state of the visual indicator.
  • the insulating layer comprises a clear (e.g. colourless) material such that the insulating layer does not prevent user inspection of the visual indicator.
  • the insulating layer is provided as a window to the housing.
  • the visual indicator comprises a colour change material that defines a first colour state below a transition temperature and a second colour state above said transition temperature.
  • the colour change material is typically selected to have a transition temperature, which allows the user to differentiate between a 'too cold to use' state (i.e. below the transition temperature) and a 'sufficiently warm to use' state (i.e. above the transition temperature).
  • Typical applications of the auto-injector herein are with a syringe containing a liquid drug formulation, which is designed for refrigerated storage (e.g. at from 2- 8°C) and for injected delivery at room temperature (e.g. at or about 18-30°C).
  • the transition temperature is thus, selected to be from 18 to 30°C, particularly from 20 to 25°C.
  • the first colour state is suitably visually distinct from the second colour state.
  • the first colour state is one colour and the second colour state is another colour.
  • the first colour state is colourless and the second colour state is a colour or alternatively, the second colour state is colourless and the first colour state is a colour.
  • the visual indicator is provided with an indicium, particularly a text indicium, which suitably lies beneath (i.e. underneath) the colour change material (e.g. provided to a base upon which the colour change material is applied).
  • the indicium comprises a 'not ready to use' indicium, which is visible when the colour change material is in a first colourless state, but which is obscured when the colour change material is in a second colour state.
  • the indicium comprises a 'ready to use' indicium, which is obscured when the colour change material is in a first colour state, and which is visible when the colour change material is in a second colourless state.
  • thermochromic materials which are selected to meet the requirements of the visual indicator.
  • Thermochromic materials are known e.g. from Kirk-Othmer Encyclopaedia 3rd Edition, Vol. 6, p. 130.
  • Thermochromic materials can be applied as a coating or can form an integral part of the materials used to make the visual indicator (e.g. comprised within the housing and/or the syringe). Another possibility of applying thermochromic materials to the visual indicator is as a laminar covering in the form of a painting or ink.
  • the thermochromic materials used can be in the form of fine pigments particles, microencapsulated materials and/or molecular materials.
  • thermochromic dyes undergo a colour change from a specific colour to colourless in a reversible manner.
  • low temperature thermochromic dyes which change their colour from colourless at room temperature to a certain colour upon being cooled.
  • Background colour pigments can be provided in combination with the thermochromic materials such that when the thermochromic material changes to colourless the background pigment becomes dominant for the colour. For example if a yellow background pigment is mixed with a red thermochromic material the visible colour will change from orange to yellow at the temperature the thermochromic materials changes colour.
  • thermochromic materials are marketed e.g. by Sun Chemical and Clariant.
  • Exemplary classes of thermochromic materials suitable herein are liquid crystals and leuco dyes.
  • Preferably both classes of materials are encapsulated in suitable microcapsules.
  • Liquid crystals are very sensitive to temperature changes and change colour even in a temperature range of 0.1 0 C, typically from black to a colour. Application of liquid crystals typically requires highly specialized printing.
  • the colour change characteristics of liquid crystals are typically dependent on the selective reflection of certain wavelengths by the crystallic structure of the material, as it changes between a low-temperature crystallic phase, through an anisotropic chiral or twisted nematic phase, to a high-temperature isotropic liquid phase.
  • the twisted nematic phase has the molecules oriented in layers with regularly changing orientation, which gives them periodic spacing.
  • the light passing the crystal undergoes Bragg diffraction on these layers and the wavelength with the greatest constructive interference is reflected back, which is perceived as a spectral color.
  • thermal expansion occurs, resulting in change of spacing between the layers, and therefore in the reflected wavelength.
  • thermochromic liquid crystal can therefore continuously range from black through the spectral colors to black again, depending on the temperature.
  • liquid crystal materials are cholesteryl nonanoate or cyanobiphenyls.
  • Liquid crystals are sometimes microencapsulated, in the form of a suspension.
  • Leuco dyes typically change colour in a temperature increment of 3 to 6°C, in most cases from coloured to clear (uncoloured).
  • the benefit of leuco dyes is that they can be easily applied by printing or by admixing with a polymer.
  • Suitable colour change materials herein are based on mixtures of leuco dyes with other chemicals, displaying a color change (usually between the colorless leuco form and the colored form) in dependence on temperature.
  • the dyes usually employed in the form of microcapsules with the mixture sealed inside.
  • the dyes most commonly used are spirolactones, fluorans, spiropyrans, and fulgides.
  • the weak acids include bisphenol A, parabens, 1 ,2,3-triazole derivates, and 4-hydroxycoumarin and act as proton donors, changing the dye molecule between its leuco form and its protonated colored form.
  • Leuco dyes are usually used in combination with a pigment that produces a color change between the color of the base pigment and the color of the pigment combined with the color of the non-leuco form of the leuco dye.
  • the auto-injector herein is useful where the liquid drug formulation to be injected has a viscosity profile that is critically temperature dependent. It will be appreciated that the more viscous the formulation, the more force will be required to expel it through the needle for delivery to the patient.
  • the syringe of the auto-injector herein contains a liquid drug formulation, which is designed for refrigerated storage (e.g. at from 2-8°C) and for injected delivery at room temperature (e.g. at or about 18-30 0 C).
  • the transition temperature is thus, selected to be within the range from 15 to 30°C, particularly from 15 to 25°C, preferably from 15 to 18°C.
  • the auto-injector herein has particular utility where that liquid drug formulation has a viscosity profile that changes critically on warming from a refrigerated storage temperature to room temperature. That utility is most pronounced where the liquid drug formulation is too viscous for effective injected delivery at the refrigerated storage temperature, but of sufficiently lower viscosity for effective injected delivery at room temperature.
  • One measure of 'ease of injected delivery' is the time for complete injected delivery of a dose of the liquid drug formulation, which for patient comfort reasons is preferably less than 10 seconds.
  • viscosity is not the only factor affecting the 'ease of injected delivery' of a liquid drug formulation from a syringe in an auto injector. Bore diameter of the syringe needle and force (e.g. spring force) deliverable by the actuating mechanism are also critical factors. Nonetheless, Applicant has found that the auto-injector herein is of particular utility where the viscosity of the liquid drug formulation is less than 120 mPa.s (120 centipoise), preferably less than 100 mPa.s (100 centipoise) at a delivery temperature of 2O 0 C.
  • kits of parts comprising an auto-injector as described above; and a syringe containing a liquid drug formulation.
  • kit of parts comprising an auto-injector as described above; and packaging therefor; and optionally a syringe containing a liquid drug formulation.
  • Suitable packaging typically comprises a container for the auto-injector and syringe.
  • the packaging comprises a compartment for the auto- injector pre-loaded with the syringe.
  • the packaging comprises a separate compartment for a 'kit' of the auto-injector and the syringe.
  • Figure 1 is a sectional view from the side of a first auto-injector in accord with the present invention
  • Figure 2 is a perspective view from the side of the first auto-injector of Figure 1 ;
  • Figures 3a and 3b show a visual indicator label suitable for use with the first auto-injector of Figures 1 and 2;
  • Figure 4 shows a cross-sectional view of a visual applicator as applied to a housing part of an auto-injector in accord with the present invention.
  • Figure 1 shows an auto-injector device 1 herein that is arranged for use with a syringe 10 that contains a liquid drug formulation 5.
  • the auto-injector device 1 comprises a housing 20 that is arranged for receipt of the syringe 10 and is sized and shaped for this purpose.
  • the syringe 10 comprises a barrel 12 for holding the liquid drug formulation 5; a hollow needle 14 at one end of the barrel 12; and a plunger 16 that is arranged for axial movement within the barrel 12 such as to enable the liquid drug formulation 5 to be expelled through the hollow needle 14.
  • the needle 14 defines a needle bore 15, which is of circular cross-section (e.g. 23G, 25G or 27G bore diameter).
  • the housing 20 of the auto-injector device 1 defines a housing cavity within which the syringe 10 is received.
  • the housing 20 of the auto- injector is provided with a barrel housing part 22 that is provided with a first barrel-retaining circular projection 30 against which a first circular barrel lip 13 of the syringe barrel 12 seats.
  • the housing 20 is further provided with a light spring-retaining circular projection 32 against which a first end of a light compression spring 35 seats. The second end of the light compression spring 35 seats against a second circular barrel lip 11 of the syringe barrel 12.
  • the syringe barrel 12 is therefore retained within the barrel housing part 22, within which (in the absence of any other restraints) it is axially movable subject to the biasing force of the light compression spring 35, which biases the syringe barrel 12 into the barrel housing part 22.
  • this movable, but lightly spring-biased syringe barrel 12 critically affects the positioning of the syringe needle 14, which is in fixed relation to the syringe barrel 12.
  • the needle 14 does not protrude from the housing 20 other than when expelling the liquid drug formulation 5 during an injection procedure.
  • the housing 20 is arranged such that a needle receiving part 24 thereof wholly houses the needle 14 when the syringe barrel 12, and hence needle 14, are subject to the bias of the light compression spring 35. This position (as shown in Figure 1 ) corresponds to a normal rest position.
  • the biasing action of the light compression spring 35 is overcome and the syringe barrel 12 and needle 14 move axially such that the tip of the needle 14 protrudes out through the delivery aperture 25 of the needle-receiving part 24 of the housing 20 to enable the liquid drug formulation 5 to be delivered by injection to a patient.
  • Actuation of the syringe 10 occurs in response to plunging of the plunger 16 into the barrel 12 of the syringe 10, which causes the liquid drug formulation 5 to be expelled through the needle 14.
  • the plunger-receiving part 26 of the housing 20 receives the syringe plunger 16.
  • the plunger 16 is axially movable within that plunger-receiving part 26 from a rest position, in which it is withdrawn from the barrel 16 (as shown in Figure 1 ) to a delivery position, in which it is moved into the barrel 12 for expelling of the liquid drug formulation 5 contents thereof.
  • the actuating mechanism of the auto-injector device 1 comprises a carriage 40 that grips the head 17 of the syringe plunger 16.
  • the carriage 40 is axially movable within the housing 20, and such axial movement is arranged to cause plunging of the plunger 16 into the syringe barrel 12.
  • the carriage 40 seats against a first end of a strong compression spring 45, the other end of which seats against the far wall 29 of the housing 20, such that the strong spring 45 potentially acts to force the carriage 40, and hence plunger 16 towards the plunged in (i.e. delivery) position.
  • the action of the strong spring 45 on the carriage is however, subject to the release of a trigger mechanism comprising lever release arms 50, which pivotally attach at pivots 51 to the housing 20 and whose finger ends 52 act on the carriage 40 to prevent its axial movement under the spring force of the strong spring 45.
  • a trigger mechanism comprising lever release arms 50, which pivotally attach at pivots 51 to the housing 20 and whose finger ends 52 act on the carriage 40 to prevent its axial movement under the spring force of the strong spring 45.
  • the trigger mechanism is released by user pressing as shown by arrows A, A' on the release button ends 54 of the lever release arms to pivot the finger ends 52 thereof away from the carriage 40.
  • the carriage 40, and hence syringe plunger 16 are then forcefully moved by release of energy stored in the strong spring 45.
  • Two actions result. Firstly, the action of the light spring 35 is overcome such that the barrel 12 and needle 14 of the syringe move axially such that the tip of the needle 15 protrudes from the delivery aperture 25 of the needle-receiving part 24 of the housing 20. Secondly, the plunger 16 plunges into the syringe barrel 12 to force the liquid drug formulation 5 there from into the needle 14 and thence for delivery by injection to a patient from the needle tip 15 thereof.
  • Figure 2 shows that the housing 20 of the auto-injector device 1 is provided with a label 60 comprising a colour change material 62.
  • the label 60 adhesively adheres to the surface of the housing 20.
  • the colour change material 62 defines a first colour state (e.g. blue) below a transition temperature and a second colour state (e.g. red) above said transition temperature.
  • the transition temperature of the colour change material 62 is selected to allow the user to differentiate between a 'too cold to use' state (i.e. below the transition temperature) and a 'sufficiently warm to use' state (i.e. above the transition temperature).
  • the syringe 10 contains a liquid drug formulation, which is designed for refrigerated storage (e.g. at from 2-8°C) and for injected delivery at room temperature (e.g. at or about 18-3O 0 C).
  • the transition temperature of the colour change material i.e. blue to red
  • the transition temperature of the colour change material is selected to be from 15 to 30°C, particularly from 15 to 25 0 C, preferably from 15 to 18°C.
  • the auto-injector device 1 is initially stored in a fridge at less than 5°C.
  • the auto-injector device 1 is removed from the fridge and the label indicates the first (i.e. blue) 'too cold to use' colour state.
  • the device 1 and its liquid drug formulation 5 contents warm up until they reach near room temperature.
  • the label indicates the second (i.e. red) 'ready to use' colour state.
  • the auto-injector device 1 may then be used by a patient in an injection procedure for injected delivery of the liquid drug formulation 5.
  • Figures 3a and 3b show an alternative label 160 comprising a colour change material 162, which can be used with the auto-injector device 1 of Figure 1 as an alternative to the label 60 of Figure 2.
  • the colour change material 162 defines a colour state (e.g. red) below a transition temperature and a colourless state (e.g. clear) above said transition temperature.
  • the transition temperature of the colour change material 162 is again selected to allow the user to differentiate between a 'too cold to use' state (i.e. below the transition temperature) and a 'sufficiently warm to use' state (i.e. above the transition temperature).
  • the label 160 is provided with a 'ready to use' text indicium 164 that lies on the surface of the label beneath and upon which the colour change material 162 is provided as an over-layer.
  • the indicium 164 is obscured when the colour change material 162 is in the 'too cold to use' colour state but as shown at Figure 3b is visible when the colour change material is in the 'ready to use' colourless state.
  • Figure 4 shows in cross-sectional view part of the housing 220 of an auto- injector herein provided with a label 260 including a colour change material 262.
  • the auto-injector may in aspects, have the form of the first auto-injector device 1 of Figure 1.
  • the label 260 may in aspects, have the form of the label 60 of Fig. 2 or that of label 160 of Figs. 3a and 3b.
  • the label 260 of Fig. 4 is provided with a window 264 comprised of an insulating clear and colourless polymeric material.
  • the window 264 acts as an insulating barrier between the colour change material 262 of the label 260 and any temperature stimuli, which are present externally to the housing 220 of the auto- injector.
  • the colour change material 262 will adopt a colour state that provides a representative indication of the temperature state of the housing 220 of the auto-injector rather than that of any adjacent external stimuli (e.g. fingers and/or hand of the user).
  • the auto-injector of the invention is suitable for the injected delivery of drug, particularly for the treatment and/or prophylaxis of a number of diseases, disorders or conditions, including infections (viral, e.g. HIV infection, bacterial, fungal and parasitic); endotoxic shock associated with infection; inflammatory diseases/autoimmunity such as osteoarthritis, rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus (SLE), asthma, Alzheimer's Disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome and psoriasis; immune mediated inflammatory disorders of the central and peripheral nervous system such as multiple sclerosis and Guillain-Barr syndrome; graft-versus-host disease; organ transplant rejection; pain; cancer (including solid tumours such as melanomas, hepatoblastomas, sarcomas, squamous cell carcinomas, transitional cell cancers, ovarian cancers and hematologic mal
  • cystic fibrosis and sickle cell anaemia growth disorders
  • heart disease including ischaemic diseases such as myocardial infarction as well as atherosclerosis and intravascular coagulation
  • bone disorders such as osteopenia and osteoporosis
  • metabolic/idiopathic disease e.g. diabetes.
  • Appropriate drugs may thus be selected from biologically active agents, including chemical entities, polysaccharides, steroids and, especially, naturally occurring and recombinant proteins, including glycoproteins, polypeptides and oligopeptides and polymeric derivatives thereof.
  • Particular proteins, polypeptides and oligopeptides include hormones, such as insulin, epinephrine, norepinephrine, adrenocorticotrophin, somatotropin, erythropoietin and oxytocin; cytokines, such as lymphokines, chemokines and interleukins and receptors therefor, e.g.
  • IFN interferon- ⁇ , IFN- ⁇ , IFN- ⁇ , granulocyte monocyte colony stimulating factor, tumour necrosis factor- ⁇
  • growth factors such as nerve growth factor and platelet-derived growth factor
  • enzymes such as tissue plasminogen activator
  • immunoglobulins immunoglobulins.
  • Immunoglobulins include whole antibodies and functionally active fragments and/or derivatives thereof, for example polyclonal, monoclonal, recombinant, multi-valent, mono- or multi-specific, humanised or chimeric antibodies, single chain antibodies, Fab fragments, Fab' and F(ab') 2 fragments.
  • Polymeric derivatives of such proteins, polypeptides and oligopeptides include derivatives formed between the protein, polypeptide or oligopeptide and a naturally occurring or synthetic polymer, e.g. a polysaccharide or a polyalylklene polymer such as a poly(ethyleneglycol) [PEG] or derivative thereof, e.g. methoxypoly(ethyleneglycol) [mPEG].
  • the auto-injector device herein has been found to be of particular utility where the drug is an immunoglobulin or a fragment thereof, especially a PEGylated or mPEGylated antibody fragment.
  • liquid drug formulations herein are typically aqueous formulations, which comprise the drug in solution and additionally other optional formulation components, which may include buffers (e.g. lactate, acetate), NaCI, and pH modifiers (e.g. NaOH).
  • buffers e.g. lactate, acetate
  • NaCI e.g. NaCI
  • pH modifiers e.g. NaOH
  • the auto-injector device herein has been found to be of particular utility wherein the concentration of the drug (e.g. a therapeutic biologic type drug) in the liquid drug formulation is quite high.
  • the drug e.g. a therapeutic biologic type drug
  • the auto-injector device has been found to be of particular utility wherein the concentration of the drug is greater than 100mg/ml, particularly greater than 150mg/ml such as 200mg/ml.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un injecteur automatique (1) pour une seringue (10) qui est adapté pour être utilisé lors de la délivrance d'un médicament par injection à un patient. L'injecteur automatique comprend un logement (20) arrangé pour recevoir une seringue contenant une formulation de médicament liquide, - un mécanisme d'actionnement destiné à actionner ladite seringue (10) pour délivrer ladite formulation liquide à un patient ; et un indicateur visuel comprenant un matériau changeant de couleur (62) qui définit un premier état chromatique en dessous d'une température de transition et un second état chromatique au-dessus de ladite température de transition. L'indicateur visuel est arrangé pour permettre à l'utilisateur de faire la différence entre un état 'trop froid pour l'utilisation' (c'est-à-dire, en dessous de la température de transition) et un état 'suffisamment chaud pour l'utilisation'.
PCT/GB2008/001871 2007-05-31 2008-05-30 Injecteur automatique Ceased WO2008146021A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0710433.4 2007-05-31
GBGB0710433.4A GB0710433D0 (en) 2007-05-31 2007-05-31 Auto-injector

Publications (1)

Publication Number Publication Date
WO2008146021A1 true WO2008146021A1 (fr) 2008-12-04

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GB (1) GB0710433D0 (fr)
WO (1) WO2008146021A1 (fr)

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WO2010100213A1 (fr) 2009-03-05 2010-09-10 Sanofi-Aventis Deutschland Gmbh Dispositif d'administration de médicaments
WO2011012849A1 (fr) 2009-07-28 2011-02-03 Ucb Pharma S.A. Injecteur
WO2011067268A1 (fr) 2009-12-02 2011-06-09 Sanofi-Aventis Deutschland Gmbh Dispositif d'administration de médicament et emballage associé
US8052645B2 (en) 2008-07-23 2011-11-08 Avant Medical Corp. System and method for an injection using a syringe needle
US8177749B2 (en) 2008-05-20 2012-05-15 Avant Medical Corp. Cassette for a hidden injection needle
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WO2012012270A3 (fr) * 2010-07-23 2012-06-14 Warsaw Orthopedic, Inc. Dispositifs de distribution de matériau de remplacement osseux et procédés d'utilisation
WO2012130901A1 (fr) * 2011-03-30 2012-10-04 Sanofi-Aventis Deutschland Gmbh Dispositif d'injection
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EP2656865A1 (fr) * 2012-04-24 2013-10-30 Sanofi-Aventis Deutschland GmbH Porte-seringue avec gaine de protection d'aiguille et mémoire de données pour auto-injecteur médical
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CN109843357A (zh) * 2016-10-25 2019-06-04 赛诺菲-安万特德国有限公司 状态指示器和带状态指示器的药物递送装置以及药物递送装置的制造方法
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EP3643270A1 (fr) * 2018-10-22 2020-04-29 VOCO GmbH Dispositif doté d'un indicateur de température thermochromique permettant de recevoir, chauffer et appliquer des matières dentaires
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WO2021071694A1 (fr) * 2019-10-08 2021-04-15 Amgen Inc. Indicateur de température pour dispositif d'administration de médicament
WO2022182487A1 (fr) * 2021-02-24 2022-09-01 Carefusion 303, Inc. Dispositif de minuterie de nécessaires à perfusion
US12226614B2 (en) 2020-12-31 2025-02-18 Regeneron Pharmaceuticals, Inc. Auto-injector and related methods of use

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US10864324B2 (en) 2008-05-20 2020-12-15 Avant Medical Corp. Autoinjector system
US8177749B2 (en) 2008-05-20 2012-05-15 Avant Medical Corp. Cassette for a hidden injection needle
US11883633B2 (en) 2008-05-20 2024-01-30 Avant Medical Corp. Autoinjector system
US9974904B2 (en) 2008-05-20 2018-05-22 Avant Medical Corp. Autoinjector system
US10792426B2 (en) 2008-05-20 2020-10-06 Avant Medical Corp. Autoinjector system
US9925336B2 (en) 2008-05-20 2018-03-27 Avant Medical Corp. Cassette for a hidden injection needle
US8052645B2 (en) 2008-07-23 2011-11-08 Avant Medical Corp. System and method for an injection using a syringe needle
US9616173B2 (en) 2008-07-23 2017-04-11 Avant Medical Corporation System and method for an injection using a syringe needle
US10639422B2 (en) 2008-07-23 2020-05-05 Avant Medical Corp. System and method for an injection using a syringe needle
US11724032B2 (en) 2008-07-23 2023-08-15 Avant Medical Corp. System and method for an injection using a syringe needle
US12186535B2 (en) 2008-07-23 2025-01-07 Avant Medical Corp. System and method for an injection using a syringe needle
US8181849B2 (en) 2008-12-30 2012-05-22 Medtronic Minimed, Inc. Color detection system for detecting reservoir presence and content in device
US8424753B2 (en) 2008-12-30 2013-04-23 Medtronic Minimed, Inc. Color detection system for detecting reservoir presence and content in device
WO2010078084A2 (fr) 2008-12-30 2010-07-08 Medtronic Minimed, Inc. Système de détection de couleur destiné à détecter la présence et le contenu d’un réservoir dans un dispositif
WO2010078084A3 (fr) * 2008-12-30 2010-09-23 Medtronic Minimed, Inc. Système de détection de couleur destiné à détecter la présence et le contenu d’un réservoir dans un dispositif
WO2010100213A1 (fr) 2009-03-05 2010-09-10 Sanofi-Aventis Deutschland Gmbh Dispositif d'administration de médicaments
US8827964B2 (en) 2009-03-05 2014-09-09 Sanofi-Aventis Deutschland Gmbh Drug delivery device
WO2011012849A1 (fr) 2009-07-28 2011-02-03 Ucb Pharma S.A. Injecteur
US9452262B2 (en) 2009-12-02 2016-09-27 Sanofi-Aventis Deutschland Gmbh Drug delivery device and associated packaging
JP2013512703A (ja) * 2009-12-02 2013-04-18 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 薬物送達デバイス及び関連包装
WO2011067268A1 (fr) 2009-12-02 2011-06-09 Sanofi-Aventis Deutschland Gmbh Dispositif d'administration de médicament et emballage associé
US8968254B2 (en) 2009-12-02 2015-03-03 Sanofi-Aventis Deutschland Gmbh Drug delivery device and associated packaging
WO2012012270A3 (fr) * 2010-07-23 2012-06-14 Warsaw Orthopedic, Inc. Dispositifs de distribution de matériau de remplacement osseux et procédés d'utilisation
US8486080B2 (en) 2010-07-23 2013-07-16 Warsaw Orthopedic, Inc. Bone replacement material delivery devices and methods of monitoring bone replacement material
WO2012130901A1 (fr) * 2011-03-30 2012-10-04 Sanofi-Aventis Deutschland Gmbh Dispositif d'injection
US12350480B2 (en) 2011-04-20 2025-07-08 Amgen Inc. Autoinjector apparatus
US11419990B2 (en) 2011-04-20 2022-08-23 Amgen Inc. Autoinjector apparatus
US10918805B2 (en) 2011-04-20 2021-02-16 Amgen Inc. Autoinjector apparatus
US10092706B2 (en) 2011-04-20 2018-10-09 Amgen Inc. Autoinjector apparatus
US11986643B2 (en) 2011-04-20 2024-05-21 Amgen Inc. Autoinjector apparatus
US9579460B2 (en) 2011-05-12 2017-02-28 Owen Mumford Limited Injection devices
GB2490721A (en) * 2011-05-12 2012-11-14 Owen Mumford Ltd Injection devices
CN103533974A (zh) * 2011-05-12 2014-01-22 欧文蒙福德有限公司 注射装置
EP2707060B1 (fr) * 2011-05-12 2019-08-21 Owen Mumford Limited Dispositifs d'injection
WO2013151702A1 (fr) * 2012-04-03 2013-10-10 Medimmune, Llc Dispositifs ayant des indicateurs de réponse thermochromique
EP2833855A4 (fr) * 2012-04-03 2016-08-17 Medimmune Llc Dispositifs ayant des indicateurs de réponse thermochromique
US20150051579A1 (en) * 2012-04-03 2015-02-19 Medimmune, Llc Devices having thermochromic response indicators
CN104427964A (zh) * 2012-04-03 2015-03-18 米迪缪尼有限公司 具有热变色应答指示剂的装置
USD1076075S1 (en) 2012-04-20 2025-05-20 Amgen Inc. Pharmaceutical product cassette for an injection device
USD898908S1 (en) 2012-04-20 2020-10-13 Amgen Inc. Pharmaceutical product cassette for an injection device
USD829890S1 (en) 2012-04-20 2018-10-02 Amgen Inc. Injection device
EP2656865A1 (fr) * 2012-04-24 2013-10-30 Sanofi-Aventis Deutschland GmbH Porte-seringue avec gaine de protection d'aiguille et mémoire de données pour auto-injecteur médical
WO2013160152A1 (fr) * 2012-04-24 2013-10-31 Sanofi-Aventis Deutschland Gmbh Support de seringue ayant un protecteur d'aiguille et dispositif de stockage de données destiné à être utilisé dans un dispositif médical d'auto-injection
CN104379195A (zh) * 2012-04-24 2015-02-25 赛诺菲-安万特德国有限公司 医用自动注射装置用具有针护罩和数据存储装置的注射筒托架
US10092703B2 (en) 2013-03-15 2018-10-09 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
US10492990B2 (en) 2013-03-15 2019-12-03 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
US10786629B2 (en) 2013-03-15 2020-09-29 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
US11020537B2 (en) 2013-03-15 2021-06-01 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
US11944798B2 (en) 2013-03-15 2024-04-02 Amgen Inc. Drug cassette, autoinjector, and autoinjector system
US11986637B2 (en) 2016-10-25 2024-05-21 Sanofi-Aventis Deutschland Gmbh State indicator and drug delivery device with a state indicator and a method for manufacturing a drug delivery device
CN109843357A (zh) * 2016-10-25 2019-06-04 赛诺菲-安万特德国有限公司 状态指示器和带状态指示器的药物递送装置以及药物递送装置的制造方法
US11207466B2 (en) 2016-10-25 2021-12-28 Sanofi-Aventis Deutschland Gmbh State indicator and drug delivery device with a state indicator and a method for manufacturing a drug delivery device
EP3643270A1 (fr) * 2018-10-22 2020-04-29 VOCO GmbH Dispositif doté d'un indicateur de température thermochromique permettant de recevoir, chauffer et appliquer des matières dentaires
WO2021071694A1 (fr) * 2019-10-08 2021-04-15 Amgen Inc. Indicateur de température pour dispositif d'administration de médicament
JP2022552184A (ja) * 2019-10-08 2022-12-15 アムジエン・インコーポレーテツド 薬物送達デバイスの温度表示部
AU2020362062B2 (en) * 2019-10-08 2025-07-10 Amgen Inc. Temperature indicator for drug delivery device
US12226614B2 (en) 2020-12-31 2025-02-18 Regeneron Pharmaceuticals, Inc. Auto-injector and related methods of use
WO2022182487A1 (fr) * 2021-02-24 2022-09-01 Carefusion 303, Inc. Dispositif de minuterie de nécessaires à perfusion

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