WO2013065055A1 - Electronic autoinjector apparatus and cassettes for use therewith - Google Patents

Electronic autoinjector apparatus and cassettes for use therewith Download PDF

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Publication number
WO2013065055A1
WO2013065055A1 PCT/IL2012/050441 IL2012050441W WO2013065055A1 WO 2013065055 A1 WO2013065055 A1 WO 2013065055A1 IL 2012050441 W IL2012050441 W IL 2012050441W WO 2013065055 A1 WO2013065055 A1 WO 2013065055A1
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WO
WIPO (PCT)
Prior art keywords
autoinjector
electronic
cassette
syringe
electronic autoinjector
Prior art date
Application number
PCT/IL2012/050441
Other languages
French (fr)
Inventor
Nimrod Lev
Original Assignee
Medimop Medical Projects Ltd
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 Medimop Medical Projects Ltd filed Critical Medimop Medical Projects Ltd
Publication of WO2013065055A1 publication Critical patent/WO2013065055A1/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
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/002Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/13General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/14Detection of the presence or absence of a tube, a connector or a container in an apparatus
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3546Range
    • A61M2205/3569Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/35Communication
    • A61M2205/3576Communication with non implanted data transmission devices, e.g. using external transmitter or receiver
    • A61M2205/3592Communication with non implanted data transmission devices, e.g. using external transmitter or receiver using telemetric means, e.g. radio or optical transmission
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • A61M2205/502User interfaces, e.g. screens or keyboards
    • A61M2205/505Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6054Magnetic identification systems
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6063Optical identification systems
    • A61M2205/6081Colour codes
    • 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
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8237Charging means
    • A61M2205/8256Charging means being integrated in the case or housing of the apparatus
    • 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
    • A61M2209/00Ancillary equipment
    • A61M2209/01Remote controllers for specific apparatus
    • 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
    • A61M2209/00Ancillary equipment
    • A61M2209/06Packaging for specific medical equipment
    • 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
    • A61M2209/00Ancillary equipment
    • A61M2209/08Supports for equipment
    • A61M2209/084Supporting bases, stands for equipment
    • A61M2209/086Docking stations
    • 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
    • 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
    • A61M5/46Devices 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 controlling depth of insertion

Definitions

  • This invention relates to electronic autoinjectors and cassettes for use therewith.
  • Autoinjectors include a handheld pen-like cartridge holder for holding replaceable pre-filled cartridges and a spring based mechanism for subcutaneous injections of liquid drug dosages from a pre-filled cartridge. Autoinjectors are typically designed for self-administration or administration by untrained personnel. Autoinjectors are available to dispense either single dosages or multiple dosages from a pre-filled cartridge. Autoinjectors enable different user settings including inter alia injection depth, injection speed, and the like.
  • Electronic autoinjectors include a user control interface for inputting user instructions and a controller operated motorized mechanism for dispensing liquid drug dosages from pre-filled cartridges.
  • the user control interface enables device settings including inter alia date and time, patient details, language of operation, and the like. Also setting of a needle injection profile including inter alia injection depth, needle penetration speed, dwell time, and the like, for injecting a needle at an injection site. Also, the setting of a drug administration profile including inter alia injection speed, injection time, and the like, for injecting a liquid drug at an injection site.
  • electronic autoinjectors enable docketing of dose logs, cartridge logs, and the like.
  • PCT International Application No. PCT/US2010/040893 entitled Method and Apparatus for Syringe Injection of Fluids published under PCT International Publication No. WO 2011/005679 discloses a system for delivering or withdrawing a fluid to or from the body of a patient in a manner that permits delivery to be controlled based upon feedback from the patient.
  • the system includes a syringe assembly providing a syringe operably coupled to one or more sensors adapted to determine one or more corresponding parameters associated with fluid delivery and/or withdrawal, and a monitor adapted to be communicably associated with the one or more sensors of the syringe assembly, and optionally with other sensors or inputs providing additional parameters as well.
  • the monitor includes one or more read out mechanisms either directly or indirectly corresponding to the one or more fluid delivery/withdrawal parameters, and optionally with one or more of the additional parameters as well.
  • the syringe assembly and the monitor can be coupled with a wired or wireless link.
  • Electronic autoinjectors are commercially available from inter alia EMD Serono under the trade names Easypod® and Cool.clickTM.
  • the present invention is directed towards electronic autoinjector apparatus including a remote control unit and a handheld pen-like electronic autoinjector for use with replaceable cassettes for administrating liquid drug dosages.
  • the remote control unit fulfils multiple functions as follows: First, storing the electronic autoinjector in a protected environment when not in use for liquid drug administration purposes. Second, including a user control interface for controlling the electronic autoinjector apparatus. The user control interface enables inputting user instructions to the electronic autoinjector and also providing user guidance and information. Third, enabling storage and output of information for patient monitoring purposes, maintenance purposes, and the like. And lastly, charging a rechargeable electronic autoinjector.
  • Electronic autoinjector apparatus of the present invention can be designed and pre-programmed to be used with a first type of cassette only, pre- filled with an administration ready liquid drug for immediate patient administration.
  • electronic autoinjector apparatus of the present invention can be designed and pre-programmed to be a used with a second type of cassette only pre-filled with liquid contents for use with a drug vial for forming a liquid drug prior to patient administration.
  • the liquid contents can be constituted by a diluent only for reconstituting a powder drug stored in a drug vial into a liquid drug.
  • the liquid contents can include an active liquid component for mixing with a powder or liquid drug in a drug vial.
  • Electronic autoinjector apparatus of the present invention can be preferably designed to be used with both types of cassette. Operation of the electronic autoinjector apparatus depends on the type of installed cassette and accordingly the type of cassette has to be identified prior to operation.
  • the type of cassette can be identified by mechanical means, an identification tag, and the like.
  • Cassettes can include an integrally formed liquid container for storing liquid contents and a plunger for enabling injection of liquid contents from the liquid container and aspiration thereinto.
  • cassettes can be preloaded with a discrete pre-filled liquid container, for example, a syringe, a cartridge, and the like.
  • Cassettes can be designed to be pre-loaded with different sizes of pre-filled liquid containers.
  • Pre-filled cassettes containing either an administration ready liquid drug or liquid contents can have the same external configuration. Alternately, the cassettes can have different external configurations for facilitating their discrimination by users.
  • Cassettes can also be color coded for assisting their identification.
  • Pre-filled cassettes can contain liquid contents for a single drug dosage or multiple drug dosages.
  • the cassettes preferably include an identification tag for identification purposes including, for example, their contents, expiry date, and the like. The cassettes also afford needle protection after liquid drug administration to avoid needle stick injuries.
  • Fig. 1 is a pictorial view of electronic autoinjector apparatus including a remote control unit and a handheld pen-like electronic autoinjector for use with a cassette pre-loaded with a pre-filled needleless syringe;
  • Fig. 2 is a combined block diagram of the remote control unit and a perspective view of the electronic autoinjector installed with the cassette;
  • Fig. 3 is a block diagram of the electronic autoinjector
  • Fig. 4 is an exploded view of the cassette showing a syringe holder and the pre-filled needleless syringe;
  • Fig. 5 is a perspective view of an administration ready liquid drug pre- filled syringe pre-fitted with a needle
  • Fig. 6 is a perspective view of a diluent pre-filled syringe with a male Luer lock connector for use with a drug vial containing a medicament and a fluid control device for reconstituting the drug vial medicament;
  • Fig. 7A shows the electronic autoinjector installed with a cassette pre- loaded with an administration ready liquid drug pre-filled syringe in its syringe retracted position
  • Fig. 7B shows the electronic autoinjector with the cassette pre-loaded with its administration ready liquid drug pre-filled syringe in its syringe forward position
  • Fig. 8A shows the electronic autoinjector installed with a cassette preloaded with an administration ready liquid drug pre-filled syringe with its syringe plunger in its plunger retracted position;
  • Fig. 8B shows the electronic autoinjector installed with the cassette preloaded with its administration ready liquid drug pre-filled syringe with its syringe plunger in its plunger forward position;
  • Figs. 9A-9F show the use of the electronic autoinjector apparatus for administrating a liquid drug from an administration ready liquid drug pre-filled syringe to a patient;
  • Figs. 10A-10G show the use of the electronic autoinjector apparatus for preparing a reconstituted liquid drug filled syringe ready for administration to a patient.
  • Figs. 10A-10G show the use of the electronic autoinjector apparatus for preparing a reconstituted liquid drug filled syringe ready for administration to a patient.
  • Figures 1 and 2 show electronic autoinjector apparatus 100 including a remote control unit 101 for use with a handheld pen-like electronic autoinjector 102.
  • the remote control unit 101 includes a base 103 and a cover 104 for closing the base 103.
  • the base 103 includes a storage cavity 106 for snugly receiving the electronic autoinjector 102 when not in use for liquid drug administration purposes.
  • the electronic autoinjector 102 has a longitudinal autoinjector axis 102 A for manual sliding installation of a cassette 107 therein and sliding removal therefrom.
  • the electronic autoinjector apparatus 100 has two different modes of operation depending on whether it is installed with a cassette 107 including an administration ready liquid drug or liquid contents for use with a drug vial.
  • the cassette 107 has a longitudinal cassette axis 107 A and can have either an integrally formed liquid container and a plunger or be configured to be pre-fitted with a discrete liquid container, for example, a syringe, a cartridge, and the like.
  • the cassette 107 is configured to be used with a pre-filled syringe and accordingly includes a longitudinal directed open ended syringe holder 108 for holding a syringe 10 pre-filled with either an administration ready liquid drug or liquid contents for use with a drug vial containing either powder or liquid drug contents.
  • Figure 2 shows the remote control unit 101 includes a power source 109 in the form of the mains, a rechargeable power pack, replaceable batteries, and the like.
  • the remote control unit 101 includes a user control interface 111 for controlling a controller 112 for controlling the operation of the electronic autoinjector apparatus 100.
  • the remote control unit 101 can include a transceiver 113 for wireless communication with the electronic autoinjector 102.
  • the storage cavity 106 can include a communication strip 114 for communication with the electronic autoinjector 102 when placed therein.
  • the storage cavity 106 can include a power socket 116 for recharging a rechargeable electronic autoinjector 102 when stored therein when not in use.
  • the user control interface 111 includes an ON/OFF switch, pushbuttons, indicator lights, a display screen, and the like.
  • the display screen can display a Graphic User Interface (GUI) for providing real time user information during operation of the electronic autoinjector apparatus.
  • GUI Graphic User Interface
  • the display screen can be a touch screen for use as an interactive graphic user interface for operating the electronic autoinjector apparatus 100.
  • the user control interface 111 can include a loudspeaker 111A for annunciating real time user information either in addition to or instead of displayed real time user information for hard of hearing patients.
  • the user control interface 111 can be formed on one or other of the inside surfaces of the base 103 and the cover 104 or divided between the two inside surfaces.
  • the ON/OFF switch, pushbuttons, indicator lights, and the like can be formed on the outside surface of the remote control unit 101.
  • Figures 1 to 3 show the electronic autoinjector 102 includes an autoinjector housing 121 having a longitudinal autoinjector housing axis 121 A, a leading autoinjector housing end 122 and a trailing autoinjector housing end 123.
  • the leading autoinjector housing end 122 is formed with a longitudinal directed open ended cassette holder 124 for manual sliding installation of a cassette 107 therein and sliding removal therefrom.
  • the leading autoinjector housing end 122 is formed with a cassette engagement mechanism 126 for securing a cassette 107 in the autoinjector housing 121 on its manual sliding insertion therein.
  • the cassette engagement mechanism 126 includes a manual operated release button 126 A for releasing a spent cassette 107 for enabling its sliding removal therefrom.
  • the leading autoinjector housing end 122 is preferably formed with a nose like protrusion 122 A constituting a minor section 125 A of the injection site contact surface 125.
  • the nose-like projection 122 A includes a skin contact sensor 130 for determining whether the electronic autoinjector 102 is being correctly oriented at a patient injection site.
  • Suitable skin contact sensors 130 include inter alia light sensors, impedance sensors, and the like.
  • the skin contact sensor 130 is intended to preclude operation of the electronic autoinjector 102 to inject a needle in the event the electronic autoinjector 102 is incorrectly oriented at a patient injection site.
  • Figure 3 shows the electronic autoinjector 102 also includes the following components: A rechargeable power source 127 for operating an autoinjector controller 128 for controlling the operation of the electronic autoinjector 102. An identification tag reader 129 for reading identification tags of installed cassettes 107. An orientation sensor 131 for determining the orientation of the electronic autoinjector 102 relative to the vertical for use during liquid drug reconstitution. A transceiver 132 for wireless communication with the transceiver 113. A communication strip 133 for communication with the communication strip 114 when the electronic autoinjector 102 is stored inside the storage cavity 106.
  • a cassette communication strip 134 for contact with a matching communication electrode strip formed on a cassette 107 on its sliding insertion thereinto for enabling bidirectional communication between the electronic autoinjector 102 and the cassette 107.
  • a cassette installation sensor 135 for detecting that a cassette has been fully and correctly inserted into the electronic autoinjector 102.
  • a power electrode 136 for contact with the power socket 116 when the electronic autoinjector 102 is stored inside the storage cavity 106 for recharging a rechargeable electronic autoinjector 102.
  • Figure 4 shows the syringe holder 108 includes a main holder body 141, a leading syringe holder end 142 and a trailing syringe holder end 143.
  • the syringe holder 108 has a stepped diameter with the leading syringe holder end 142 protruding widthwise relative to the main holder body 141 relative to the longitudinal cassette axis 107 A.
  • the leading syringe holder end 142 includes a leading contact surface 144 constituting a major section 125B of the injection site contact surface 125.
  • the cassette 107 includes an identification tag 146 including identification information for identification purposes.
  • Identification information can include inter alia its pre-filled syringe contains an administration ready liquid drug or a diluent, a lot number including its expiry date, and the like.
  • Suitable identification tags 146 include inter alia a RFID tag, a bar code, and the like.
  • the cassette 107 includes an autoinjector communication strip 147 for communication with the cassette communication strip 134 on sliding installation of the cassette 107 into the electronic autoinjector 102.
  • the syringes 10 include a tubular syringe body 11 having a leading syringe body tip 12 and a trailing syringe body end 13.
  • the syringes 10 can be formed from glass or plastic or combination of the two, or any other material that syringes can made of.
  • the trailing syringe body ends 13 include an outward directed radial flange 14 for clamping purposes for enabling displacement of a syringe 10 relative to the syringe holder 108.
  • the syringes 10 include a slidable syringe plunger 16 having a trailing syringe plunger surface 17 intended for engagement with a syringe plunger driver for enabling its displacement relative to the syringe body 11.
  • the syringes 10 are pre-filled with a pre-determined liquid volume 18 sufficient for single or multiple dosages.
  • the syringes 10 are pre-filled with either an administration ready liquid drug or liquid contents for use with a drug vial.
  • Syringes 10 pre-filled with administration ready liquid drug are hereinafter denoted by a reference number 10A.
  • Syringes 10 pre-filled with liquid contents for use with a drug vial are hereinafter denoted by a reference number 10B.
  • Figure 5 shows pre-filled syringes 10A are preferably pre-fitted with a needle 19.
  • the needle 19 can be mounted on a luer connector or integrally formed.
  • Figure 6 shows pre-filled syringes 10B are preferably formed with a male Luer lock connector 21 at their leading syringe body tip 12 and are intended for use with a drug vial 25 containing a drug vial medicament 26 in conjunction with a fluid control device 30 for reconstitution purposes.
  • the drug vials 25 are preferably standard 13/20 mm neck glass vials with either powder or liquid drug vial medicament.
  • Suitable fluid control devices 30 include inter alia commonly owned PCT International Patent Application No. PCT/IL2010/000915 entitled Inline Liquid Drug Medical Device with Linear Displaceable Sliding Flow Control Member published under PCT International Publication No. WO 2011/058548.
  • the fluid control device 30 includes a housing 31 with a syringe port 32 for screw thread engagement with a syringe lOB's male Luer lock connector 21 and a needle 33 for liquid drug administration.
  • the fluid control device 30 includes a vial adapter 34 detachably mounted on the housing 31.
  • the vial adapter 34 is intended for snap fitting onto the drug vial 25 for fluid communication therewith.
  • the vial adapter 34 includes a stem 36 with opposing arms 37 for threading engagement on the housing 31 and a blind bore 38 for receiving the needle 33.
  • the fluid control device 30 includes an initial first flow control position for establishing flow communication between the syringe port 32 and a drug vial 25 for reconstitution purposes and a subsequent second flow control position for establishing flow communication between the syringe port 32 and the needle 33 for administration purposes.
  • Detachment of the vial adapter 34 from the housing 31 automatically primes the electronic autoinjector 102 and the cassette 107 from reconstitution mode to injection mode. Such priming can be achieved by electro-optical means, mechanical means, and the like.
  • Figures 3, 7 A and 7B show the electronic autoinjector 102 also includes a syringe reciprocation mechanism 137 for reciprocating a syringe 10 relative to its syringe holder 108 between a syringe retracted position and a syringe forward position relative to the injection site contact surface 125.
  • the syringe reciprocation mechanism 137 preferably includes a clamping mechanism for releasably clamping an outward directed radial flange 14.
  • Figures 7A and 7B show the operation of the syringe reciprocation mechanism 137 for the electronic autoinjector 102 installed with a cassette 107 pre-loaded with an administration ready liquid drug pre-filled syringe 10A.
  • Figure 7 A shows the syringe reciprocation mechanism 137 in its syringe retracted position for retracting the needle 19 relative to the injection site contact surface 125.
  • the syringe reciprocation mechanism 137 initially assumes the syringe retracted position to enable the injection site contact surface 125 to be intimately placed at a patient injection site.
  • the syringe reciprocation mechanism 137 assumes the syringe retracted position after liquid drug administration to avoid needle sticks and enable safe disposable of a spent cassette 107.
  • Figure 7B shows the syringe reciprocation mechanism 137 in its syringe forward position for protruding the needle 19 relative to the injection site contact surface 125 for subcutaneous injection.
  • the operation of the syringe reciprocation mechanism 137 is similar in the case of a cassette 107 pre-loaded with a liquid contents pre-filled syringe 10B except that the positions of the syringe 10B relative to the injection site contact surface 125 may be different than in the case of the administration ready liquid drug pre-filled syringe 10A.
  • the syringe reciprocation mechanism 137 can be implemented using a pair of oppositely directed compression springs, namely, a first compression spring for effecting a forward directed syringe movement and a second compression spring for effecting a rearward directed syringe movement.
  • the syringe compression mechanism 137 can be implemented by a controller operated motor.
  • Figures 3, 8 A and 8B show the electronic autoinjector 102 also includes a plunger displacement mechanism 138 for displacing a syringe plunger 16 relative to its syringe 10 between a plunger retracted position for enabling storage of liquid contents in a syringe 10 and a plunger forward position for injecting liquid contents from a syringe 10.
  • the plunger displacement mechanism 138 includes a motorized syringe plunger driver 139 for mechanical engagement with a trailing syringe plunger surface 17. Mechanical engagement can be in the form of direct contact for displacing a syringe lOA's syringe plunger 16 forward for injecting its administration ready liquid drug.
  • FIGs 8 A and 8B show the operation of the plunger displacement mechanism 138 for the electronic autoinjector 102 installed with a cassette 107 pre-loaded with an administration ready liquid drug pre-filled syringe 10A.
  • Figure 8A shows the plunger displacement mechanism 138 in its plunger retracted position for enabling storage of liquid contents.
  • Figure 8B shows the plunger displacement mechanism 138 in its plunger forward position for injecting liquid contents from a syringe 10.
  • FIGS 9A-9F show the use of the electronic autoinjector apparatus 100 for injecting an administration ready liquid drug dosage as follows:
  • Step 1 A user opens the remote control unit and removes the electronic autoinjector from the base.
  • Step 2 The user removes a cassette 107 pre-loaded with an administration ready pre-filled syringe 10A from its sterile packing (see Figure 9A).
  • Step 3 The user inserts the cassette 107 into the electronic autoinjector 102 and powers on same (see Figure 9B).
  • the electronic autoinjector 102 reads the identification tag 146 for identification purposes.
  • the electronic autoinjector 102 communicates with the remote control unit 101 regarding the cassette 107 and downloads required information for injection purposes.
  • required information includes inter alia a predetermined needle injection profile, a predetermined drug administration profile, recommended injection sites, and the like.
  • Step 4 The remote control unit 101 instructs the user to hold the electronic autoinjector 102 at a patient injection site and press the injection site contact surface 125 thereat.
  • the electronic autoinjector apparatus 100 detects the user is correctly pressing the electronic autoinjector 102 at the patient injection site.
  • the electronic autoinjector apparatus 100 indicates to the user that injection is about to take place.
  • the electronic autoinjector 102 displaces the syringe 10A forward relative to the syringe holder 108 for injecting the needle into the patient injection site in accordance with the predetermined needle injection profile (see Figure 9C).
  • Step 5 The electronic autoinjector 102 proceeds to depress the syringe plunger 16 to inject the administration ready liquid drug in accordance with the predetermined drug administration profile (see Figure 9D).
  • Step 6 After a predetermined dwell time, the electronic autoinjector 102 retracts the now empty syringe 10A into the electronic autoinjector 102 to avoid needle stick injuries (see Figure 9E).
  • Step 7 The electronic autoinjector apparatus 100 indicates to the user that the injection has been completed and he can remove the electronic autoinjector 102 from the patient injection site.
  • Step 8 The user releases the spent cassette 107 from the electronic autoinjector 102 and disposes the spent cassette (see Figure 9F).
  • Step 9 The user powers down the electronic autoinjector 102 and returns it to the remote control unit 101 for storage in the storage cavity 106.
  • Figures 10A-10G show the use of the electronic autoinjector apparatus 100 for preparing a reconstituted liquid drug filled syringe ready for liquid drug administration to a patient.
  • Step 11 A user opens the remote control unit 101 and removes the electronic autoinjector 102 from the base 103.
  • Step 12 The remote control unit 101 instructs the user to snap fit the fluid control device 30 onto the drug vial 25 as denoted by arrow A (see Figure 10A).
  • Step 13 The remote control unit 101 instructs the user to mount the cassette 107 onto the fluid control device 30 as denoted by arrow B (see Figure 10B).
  • Step 14 The remote control unit 101 instructs the user to install the cassette 107 into the electronic autoinjector 102 as denoted by arrow C (see Figure IOC).
  • the fluid control device 30 and its attached drug vial 25 protrude from the electronic autoinjector 102 after installation.
  • Step 15 The electronic autoinjector 102 depresses the syringe plunger 16 to inject diluent into the drug vial 25 as denoted by arrow D (see Figure 10D).
  • Step 16 The remote control unit 101 instructs the user to gently agitate the electronic autoinjector 102 to reconstitute the drug vial medicament.
  • Step 17 The remote control unit 101 instructs the user to invert the electronic autoinjector 102.
  • Step 18 On detection of the inversion of the electronic autoinjector 102, the electronic autoinjector 102 retracts the syringe plunger 16 to aspirate the reconstituted liquid drug into the empty syringe as denoted by arrow E (see Figure 10E).
  • Step 19 The remote control unit 101 instructs the user to revert the electronic autoinjector 102 and detach the vial adapter 34 from the housing 31 to expose the needle 33 and to prime the electronic autoinjector 102 from reconstitution mode to injection mode (see Figure 10F).
  • Step 20 The electronic autoinjector 102 retracts the syringe to retract the needle 33 behind the injection site contact surface 125 such that the electronic autoinjector 102 is installed with a reconstituted liquid drug filled syringe 10B and is ready to be held at a patient injection site (see Figure 10G).
  • the electronic autoinjector 102 is prepared ready with a reconstituted liquid drug filled syringe 10B with the needle 33 being exposed ready for use within the confines of the cassette 107.

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Abstract

Electronic autoinjector apparatus for use with a replaceable pre-filled cassette (107) containing liquid contents for administrating a liquid drug to a patient. The electronic autoinjector apparatus includes a handheld pen-like electronic autoinjector (102) having an autoinjector housing with an open ended cassette holder for manual sliding installation of a cassette therein and sliding removal therefrom. The electronic autoinjector apparatus also includes a remote control unit (101) having a base with a storage cavity (106) for snugly receiving the electronic autoinjector when not in use and a cover (104) for closing the base, and a user control interface for operating the electronic autoinjector apparatus.

Description

ELECTRONIC AUTOINJECTOR APPARATUS AND CASSETTES
FOR USE THEREWITH
Field of the Invention
This invention relates to electronic autoinjectors and cassettes for use therewith.
Background of the Invention
Autoinjectors include a handheld pen-like cartridge holder for holding replaceable pre-filled cartridges and a spring based mechanism for subcutaneous injections of liquid drug dosages from a pre-filled cartridge. Autoinjectors are typically designed for self-administration or administration by untrained personnel. Autoinjectors are available to dispense either single dosages or multiple dosages from a pre-filled cartridge. Autoinjectors enable different user settings including inter alia injection depth, injection speed, and the like.
Electronic autoinjectors include a user control interface for inputting user instructions and a controller operated motorized mechanism for dispensing liquid drug dosages from pre-filled cartridges. The user control interface enables device settings including inter alia date and time, patient details, language of operation, and the like. Also setting of a needle injection profile including inter alia injection depth, needle penetration speed, dwell time, and the like, for injecting a needle at an injection site. Also, the setting of a drug administration profile including inter alia injection speed, injection time, and the like, for injecting a liquid drug at an injection site. Additionally electronic autoinjectors enable docketing of dose logs, cartridge logs, and the like.
PCT International Application No. PCT/US2010/040893 entitled Method and Apparatus for Syringe Injection of Fluids published under PCT International Publication No. WO 2011/005679 discloses a system for delivering or withdrawing a fluid to or from the body of a patient in a manner that permits delivery to be controlled based upon feedback from the patient. The system includes a syringe assembly providing a syringe operably coupled to one or more sensors adapted to determine one or more corresponding parameters associated with fluid delivery and/or withdrawal, and a monitor adapted to be communicably associated with the one or more sensors of the syringe assembly, and optionally with other sensors or inputs providing additional parameters as well. The monitor includes one or more read out mechanisms either directly or indirectly corresponding to the one or more fluid delivery/withdrawal parameters, and optionally with one or more of the additional parameters as well. The syringe assembly and the monitor can be coupled with a wired or wireless link.
Electronic autoinjectors are commercially available from inter alia EMD Serono under the trade names Easypod® and Cool.click™.
Summary of the Invention
The present invention is directed towards electronic autoinjector apparatus including a remote control unit and a handheld pen-like electronic autoinjector for use with replaceable cassettes for administrating liquid drug dosages. The remote control unit fulfils multiple functions as follows: First, storing the electronic autoinjector in a protected environment when not in use for liquid drug administration purposes. Second, including a user control interface for controlling the electronic autoinjector apparatus. The user control interface enables inputting user instructions to the electronic autoinjector and also providing user guidance and information. Third, enabling storage and output of information for patient monitoring purposes, maintenance purposes, and the like. And lastly, charging a rechargeable electronic autoinjector.
Electronic autoinjector apparatus of the present invention can be designed and pre-programmed to be used with a first type of cassette only, pre- filled with an administration ready liquid drug for immediate patient administration. Alternately, electronic autoinjector apparatus of the present invention can be designed and pre-programmed to be a used with a second type of cassette only pre-filled with liquid contents for use with a drug vial for forming a liquid drug prior to patient administration. The liquid contents can be constituted by a diluent only for reconstituting a powder drug stored in a drug vial into a liquid drug. Alternatively, the liquid contents can include an active liquid component for mixing with a powder or liquid drug in a drug vial. Electronic autoinjector apparatus of the present invention can be preferably designed to be used with both types of cassette. Operation of the electronic autoinjector apparatus depends on the type of installed cassette and accordingly the type of cassette has to be identified prior to operation. The type of cassette can be identified by mechanical means, an identification tag, and the like.
Cassettes can include an integrally formed liquid container for storing liquid contents and a plunger for enabling injection of liquid contents from the liquid container and aspiration thereinto. Alternatively, cassettes can be preloaded with a discrete pre-filled liquid container, for example, a syringe, a cartridge, and the like. Cassettes can be designed to be pre-loaded with different sizes of pre-filled liquid containers. Pre-filled cassettes containing either an administration ready liquid drug or liquid contents can have the same external configuration. Alternately, the cassettes can have different external configurations for facilitating their discrimination by users. Cassettes can also be color coded for assisting their identification. Pre-filled cassettes can contain liquid contents for a single drug dosage or multiple drug dosages. The cassettes preferably include an identification tag for identification purposes including, for example, their contents, expiry date, and the like. The cassettes also afford needle protection after liquid drug administration to avoid needle stick injuries.
Brief Description of Drawings
In order to understand the invention and to see how it can be carried out in practice, preferred embodiments will now be described, by way of non- limiting examples only, with reference to the accompanying drawings in which similar parts are likewise numbered, and in which: Fig. 1 is a pictorial view of electronic autoinjector apparatus including a remote control unit and a handheld pen-like electronic autoinjector for use with a cassette pre-loaded with a pre-filled needleless syringe;
Fig. 2 is a combined block diagram of the remote control unit and a perspective view of the electronic autoinjector installed with the cassette;
Fig. 3 is a block diagram of the electronic autoinjector;
Fig. 4 is an exploded view of the cassette showing a syringe holder and the pre-filled needleless syringe;
Fig. 5 is a perspective view of an administration ready liquid drug pre- filled syringe pre-fitted with a needle;
Fig. 6 is a perspective view of a diluent pre-filled syringe with a male Luer lock connector for use with a drug vial containing a medicament and a fluid control device for reconstituting the drug vial medicament;
Fig. 7A shows the electronic autoinjector installed with a cassette pre- loaded with an administration ready liquid drug pre-filled syringe in its syringe retracted position;
Fig. 7B shows the electronic autoinjector with the cassette pre-loaded with its administration ready liquid drug pre-filled syringe in its syringe forward position;
Fig. 8A shows the electronic autoinjector installed with a cassette preloaded with an administration ready liquid drug pre-filled syringe with its syringe plunger in its plunger retracted position;
Fig. 8B shows the electronic autoinjector installed with the cassette preloaded with its administration ready liquid drug pre-filled syringe with its syringe plunger in its plunger forward position;
Figs. 9A-9F show the use of the electronic autoinjector apparatus for administrating a liquid drug from an administration ready liquid drug pre-filled syringe to a patient; and
Figs. 10A-10G show the use of the electronic autoinjector apparatus for preparing a reconstituted liquid drug filled syringe ready for administration to a patient. Detailed Description of Preferred Embodiments of the Invention
Figures 1 and 2 show electronic autoinjector apparatus 100 including a remote control unit 101 for use with a handheld pen-like electronic autoinjector 102. The remote control unit 101 includes a base 103 and a cover 104 for closing the base 103. The base 103 includes a storage cavity 106 for snugly receiving the electronic autoinjector 102 when not in use for liquid drug administration purposes. The electronic autoinjector 102 has a longitudinal autoinjector axis 102 A for manual sliding installation of a cassette 107 therein and sliding removal therefrom. The electronic autoinjector apparatus 100 has two different modes of operation depending on whether it is installed with a cassette 107 including an administration ready liquid drug or liquid contents for use with a drug vial.
The cassette 107 has a longitudinal cassette axis 107 A and can have either an integrally formed liquid container and a plunger or be configured to be pre-fitted with a discrete liquid container, for example, a syringe, a cartridge, and the like. For illustrative purposes only, the cassette 107 is configured to be used with a pre-filled syringe and accordingly includes a longitudinal directed open ended syringe holder 108 for holding a syringe 10 pre-filled with either an administration ready liquid drug or liquid contents for use with a drug vial containing either powder or liquid drug contents.
Figure 2 shows the remote control unit 101 includes a power source 109 in the form of the mains, a rechargeable power pack, replaceable batteries, and the like. The remote control unit 101 includes a user control interface 111 for controlling a controller 112 for controlling the operation of the electronic autoinjector apparatus 100. The remote control unit 101 can include a transceiver 113 for wireless communication with the electronic autoinjector 102. The storage cavity 106 can include a communication strip 114 for communication with the electronic autoinjector 102 when placed therein. The storage cavity 106 can include a power socket 116 for recharging a rechargeable electronic autoinjector 102 when stored therein when not in use. The user control interface 111 includes an ON/OFF switch, pushbuttons, indicator lights, a display screen, and the like. The display screen can display a Graphic User Interface (GUI) for providing real time user information during operation of the electronic autoinjector apparatus. The display screen can be a touch screen for use as an interactive graphic user interface for operating the electronic autoinjector apparatus 100. The user control interface 111 can include a loudspeaker 111A for annunciating real time user information either in addition to or instead of displayed real time user information for hard of hearing patients. The user control interface 111 can be formed on one or other of the inside surfaces of the base 103 and the cover 104 or divided between the two inside surfaces. The ON/OFF switch, pushbuttons, indicator lights, and the like can be formed on the outside surface of the remote control unit 101.
Figures 1 to 3 show the electronic autoinjector 102 includes an autoinjector housing 121 having a longitudinal autoinjector housing axis 121 A, a leading autoinjector housing end 122 and a trailing autoinjector housing end 123. The leading autoinjector housing end 122 is formed with a longitudinal directed open ended cassette holder 124 for manual sliding installation of a cassette 107 therein and sliding removal therefrom. The leading autoinjector housing end 122 is formed with a cassette engagement mechanism 126 for securing a cassette 107 in the autoinjector housing 121 on its manual sliding insertion therein. The cassette engagement mechanism 126 includes a manual operated release button 126 A for releasing a spent cassette 107 for enabling its sliding removal therefrom.
The electronic autoinjector 102 and its installed cassette 107 together have a continuous injection site contact surface 125 for intimate contact at a patient injection site. The leading autoinjector housing end 122 is preferably formed with a nose like protrusion 122 A constituting a minor section 125 A of the injection site contact surface 125. The nose-like projection 122 A includes a skin contact sensor 130 for determining whether the electronic autoinjector 102 is being correctly oriented at a patient injection site. Suitable skin contact sensors 130 include inter alia light sensors, impedance sensors, and the like. The skin contact sensor 130 is intended to preclude operation of the electronic autoinjector 102 to inject a needle in the event the electronic autoinjector 102 is incorrectly oriented at a patient injection site.
Figure 3 shows the electronic autoinjector 102 also includes the following components: A rechargeable power source 127 for operating an autoinjector controller 128 for controlling the operation of the electronic autoinjector 102. An identification tag reader 129 for reading identification tags of installed cassettes 107. An orientation sensor 131 for determining the orientation of the electronic autoinjector 102 relative to the vertical for use during liquid drug reconstitution. A transceiver 132 for wireless communication with the transceiver 113. A communication strip 133 for communication with the communication strip 114 when the electronic autoinjector 102 is stored inside the storage cavity 106. A cassette communication strip 134 for contact with a matching communication electrode strip formed on a cassette 107 on its sliding insertion thereinto for enabling bidirectional communication between the electronic autoinjector 102 and the cassette 107. A cassette installation sensor 135 for detecting that a cassette has been fully and correctly inserted into the electronic autoinjector 102. A power electrode 136 for contact with the power socket 116 when the electronic autoinjector 102 is stored inside the storage cavity 106 for recharging a rechargeable electronic autoinjector 102.
Figure 4 shows the syringe holder 108 includes a main holder body 141, a leading syringe holder end 142 and a trailing syringe holder end 143. The syringe holder 108 has a stepped diameter with the leading syringe holder end 142 protruding widthwise relative to the main holder body 141 relative to the longitudinal cassette axis 107 A. The leading syringe holder end 142 includes a leading contact surface 144 constituting a major section 125B of the injection site contact surface 125.
The cassette 107 includes an identification tag 146 including identification information for identification purposes. Identification information can include inter alia its pre-filled syringe contains an administration ready liquid drug or a diluent, a lot number including its expiry date, and the like. Suitable identification tags 146 include inter alia a RFID tag, a bar code, and the like.
The cassette 107 includes an autoinjector communication strip 147 for communication with the cassette communication strip 134 on sliding installation of the cassette 107 into the electronic autoinjector 102.
The syringes 10 include a tubular syringe body 11 having a leading syringe body tip 12 and a trailing syringe body end 13. The syringes 10 can be formed from glass or plastic or combination of the two, or any other material that syringes can made of. The trailing syringe body ends 13 include an outward directed radial flange 14 for clamping purposes for enabling displacement of a syringe 10 relative to the syringe holder 108. The syringes 10 include a slidable syringe plunger 16 having a trailing syringe plunger surface 17 intended for engagement with a syringe plunger driver for enabling its displacement relative to the syringe body 11. The syringes 10 are pre-filled with a pre-determined liquid volume 18 sufficient for single or multiple dosages. The syringes 10 are pre-filled with either an administration ready liquid drug or liquid contents for use with a drug vial. Syringes 10 pre-filled with administration ready liquid drug are hereinafter denoted by a reference number 10A. Syringes 10 pre-filled with liquid contents for use with a drug vial are hereinafter denoted by a reference number 10B.
Figure 5 shows pre-filled syringes 10A are preferably pre-fitted with a needle 19. The needle 19 can be mounted on a luer connector or integrally formed.
Figure 6 shows pre-filled syringes 10B are preferably formed with a male Luer lock connector 21 at their leading syringe body tip 12 and are intended for use with a drug vial 25 containing a drug vial medicament 26 in conjunction with a fluid control device 30 for reconstitution purposes. The drug vials 25 are preferably standard 13/20 mm neck glass vials with either powder or liquid drug vial medicament. Suitable fluid control devices 30 include inter alia commonly owned PCT International Patent Application No. PCT/IL2010/000915 entitled Inline Liquid Drug Medical Device with Linear Displaceable Sliding Flow Control Member published under PCT International Publication No. WO 2011/058548. The fluid control device 30 includes a housing 31 with a syringe port 32 for screw thread engagement with a syringe lOB's male Luer lock connector 21 and a needle 33 for liquid drug administration. The fluid control device 30 includes a vial adapter 34 detachably mounted on the housing 31. The vial adapter 34 is intended for snap fitting onto the drug vial 25 for fluid communication therewith. The vial adapter 34 includes a stem 36 with opposing arms 37 for threading engagement on the housing 31 and a blind bore 38 for receiving the needle 33. The fluid control device 30 includes an initial first flow control position for establishing flow communication between the syringe port 32 and a drug vial 25 for reconstitution purposes and a subsequent second flow control position for establishing flow communication between the syringe port 32 and the needle 33 for administration purposes. Detachment of the vial adapter 34 from the housing 31 automatically primes the electronic autoinjector 102 and the cassette 107 from reconstitution mode to injection mode. Such priming can be achieved by electro-optical means, mechanical means, and the like.
Figures 3, 7 A and 7B show the electronic autoinjector 102 also includes a syringe reciprocation mechanism 137 for reciprocating a syringe 10 relative to its syringe holder 108 between a syringe retracted position and a syringe forward position relative to the injection site contact surface 125. The syringe reciprocation mechanism 137 preferably includes a clamping mechanism for releasably clamping an outward directed radial flange 14. Figures 7A and 7B show the operation of the syringe reciprocation mechanism 137 for the electronic autoinjector 102 installed with a cassette 107 pre-loaded with an administration ready liquid drug pre-filled syringe 10A. Figure 7 A shows the syringe reciprocation mechanism 137 in its syringe retracted position for retracting the needle 19 relative to the injection site contact surface 125. The syringe reciprocation mechanism 137 initially assumes the syringe retracted position to enable the injection site contact surface 125 to be intimately placed at a patient injection site. The syringe reciprocation mechanism 137 assumes the syringe retracted position after liquid drug administration to avoid needle sticks and enable safe disposable of a spent cassette 107. Figure 7B shows the syringe reciprocation mechanism 137 in its syringe forward position for protruding the needle 19 relative to the injection site contact surface 125 for subcutaneous injection. The operation of the syringe reciprocation mechanism 137 is similar in the case of a cassette 107 pre-loaded with a liquid contents pre-filled syringe 10B except that the positions of the syringe 10B relative to the injection site contact surface 125 may be different than in the case of the administration ready liquid drug pre-filled syringe 10A. The syringe reciprocation mechanism 137 can be implemented using a pair of oppositely directed compression springs, namely, a first compression spring for effecting a forward directed syringe movement and a second compression spring for effecting a rearward directed syringe movement. Alternatively, the syringe compression mechanism 137 can be implemented by a controller operated motor.
Figures 3, 8 A and 8B show the electronic autoinjector 102 also includes a plunger displacement mechanism 138 for displacing a syringe plunger 16 relative to its syringe 10 between a plunger retracted position for enabling storage of liquid contents in a syringe 10 and a plunger forward position for injecting liquid contents from a syringe 10. The plunger displacement mechanism 138 includes a motorized syringe plunger driver 139 for mechanical engagement with a trailing syringe plunger surface 17. Mechanical engagement can be in the form of direct contact for displacing a syringe lOA's syringe plunger 16 forward for injecting its administration ready liquid drug. Mechanical engagement can be form of threaded engagement, a bayonet engagement, and the like, for returning a syringe lOB's syringe plunger 16 from its plunger forward position to its plunger retracted position for reconstitution purposes. Figures 8 A and 8B show the operation of the plunger displacement mechanism 138 for the electronic autoinjector 102 installed with a cassette 107 pre-loaded with an administration ready liquid drug pre-filled syringe 10A. Figure 8A shows the plunger displacement mechanism 138 in its plunger retracted position for enabling storage of liquid contents. Figure 8B shows the plunger displacement mechanism 138 in its plunger forward position for injecting liquid contents from a syringe 10.
Figures 9A-9F show the use of the electronic autoinjector apparatus 100 for injecting an administration ready liquid drug dosage as follows:
Step 1 : A user opens the remote control unit and removes the electronic autoinjector from the base.
Step 2: The user removes a cassette 107 pre-loaded with an administration ready pre-filled syringe 10A from its sterile packing (see Figure 9A).
Step 3: The user inserts the cassette 107 into the electronic autoinjector 102 and powers on same (see Figure 9B). The electronic autoinjector 102 reads the identification tag 146 for identification purposes. The electronic autoinjector 102 communicates with the remote control unit 101 regarding the cassette 107 and downloads required information for injection purposes. Such required information includes inter alia a predetermined needle injection profile, a predetermined drug administration profile, recommended injection sites, and the like.
Step 4: The remote control unit 101 instructs the user to hold the electronic autoinjector 102 at a patient injection site and press the injection site contact surface 125 thereat. The electronic autoinjector apparatus 100 detects the user is correctly pressing the electronic autoinjector 102 at the patient injection site. The electronic autoinjector apparatus 100 indicates to the user that injection is about to take place. The electronic autoinjector 102 displaces the syringe 10A forward relative to the syringe holder 108 for injecting the needle into the patient injection site in accordance with the predetermined needle injection profile (see Figure 9C). Step 5: The electronic autoinjector 102 proceeds to depress the syringe plunger 16 to inject the administration ready liquid drug in accordance with the predetermined drug administration profile (see Figure 9D).
Step 6: After a predetermined dwell time, the electronic autoinjector 102 retracts the now empty syringe 10A into the electronic autoinjector 102 to avoid needle stick injuries (see Figure 9E).
Step 7: The electronic autoinjector apparatus 100 indicates to the user that the injection has been completed and he can remove the electronic autoinjector 102 from the patient injection site.
Step 8: The user releases the spent cassette 107 from the electronic autoinjector 102 and disposes the spent cassette (see Figure 9F).
Step 9: The user powers down the electronic autoinjector 102 and returns it to the remote control unit 101 for storage in the storage cavity 106.
Figures 10A-10G show the use of the electronic autoinjector apparatus 100 for preparing a reconstituted liquid drug filled syringe ready for liquid drug administration to a patient.
Step 11: A user opens the remote control unit 101 and removes the electronic autoinjector 102 from the base 103.
Step 12: The remote control unit 101 instructs the user to snap fit the fluid control device 30 onto the drug vial 25 as denoted by arrow A (see Figure 10A).
Step 13: The remote control unit 101 instructs the user to mount the cassette 107 onto the fluid control device 30 as denoted by arrow B (see Figure 10B).
Step 14: The remote control unit 101 instructs the user to install the cassette 107 into the electronic autoinjector 102 as denoted by arrow C (see Figure IOC). The fluid control device 30 and its attached drug vial 25 protrude from the electronic autoinjector 102 after installation.
Step 15: The electronic autoinjector 102 depresses the syringe plunger 16 to inject diluent into the drug vial 25 as denoted by arrow D (see Figure 10D). Step 16: The remote control unit 101 instructs the user to gently agitate the electronic autoinjector 102 to reconstitute the drug vial medicament.
Step 17: The remote control unit 101 instructs the user to invert the electronic autoinjector 102.
Step 18: On detection of the inversion of the electronic autoinjector 102, the electronic autoinjector 102 retracts the syringe plunger 16 to aspirate the reconstituted liquid drug into the empty syringe as denoted by arrow E (see Figure 10E).
Step 19: The remote control unit 101 instructs the user to revert the electronic autoinjector 102 and detach the vial adapter 34 from the housing 31 to expose the needle 33 and to prime the electronic autoinjector 102 from reconstitution mode to injection mode (see Figure 10F).
Step 20: The electronic autoinjector 102 retracts the syringe to retract the needle 33 behind the injection site contact surface 125 such that the electronic autoinjector 102 is installed with a reconstituted liquid drug filled syringe 10B and is ready to be held at a patient injection site (see Figure 10G).
Administration of the reconstituted liquid drug filled syringe 10B follows the aforesaid Steps 1 to 9 for an administration ready liquid drug pre- filled syringe 10A.
Alternatively, installation of the cassette 107 into the electronic autoinjector 102 can leave only the vial adapter 34 protruding from the electronic autoinjector 102 and not nearly the entire fluid control device 30 as shown. In this case, the electronic autoinjector 102 is prepared ready with a reconstituted liquid drug filled syringe 10B with the needle 33 being exposed ready for use within the confines of the cassette 107.
While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications, and other applications of the invention can be made within the scope of the appended claims.

Claims

CLAIMS:
1. Electronic autoinjector apparatus for administrating a liquid drug, the electronic autoinjector apparatus for use with a replaceable pre-filled cassette containing liquid contents, the electronic autoinjector apparatus comprising: (a) a handheld pen-like electronic autoinjector having an autoinjector housing with a longitudinal autoinjector housing axis, a leading autoinjector housing end and a trailing autoinjector housing end,
said leading autoinjector housing end having a longitudinal directed open ended cassette holder for manual sliding installation of a cassette therein and sliding removal therefrom; and
(b) a remote control unit having a base with a storage cavity for snugly receiving said electronic autoinjector when not in use and a cover for closing said base, and a user control interface for operating the electronic autoinjector apparatus for administrating the liquid drug.
2. Apparatus according to claim 1 wherein said leading autoinjector housing end and an installed cassette have an injection site contact surface for intimate contact at a patient injection site and said leading autoinjector housing end is formed with a skin contact sensor for determining whether said electronic autoinjector is correctly oriented at the patient injection site.
3. Apparatus according to either claim 1 or 2 wherein said electronic autoinjector includes an orientation sensor for determining the orientation of said electronic autoinjector relative to the vertical.
4. Apparatus according to any one of claims 1 to 3 wherein a cassette includes an identification tag including identification information and said electronic autoinjector reads said identification tag on insertion of said cassette therein for identification purposes.
5. Apparatus according to any one of claims 1 to 4 wherein said electronic autoinjector includes a rechargeable power source and said remote control unit recharges said rechargeable power source on storing said electronic autoinjector in said storage cavity.
6. Apparatus according to any one of claims 1 to 5 wherein said user control interface includes a loudspeaker for annunciating user information.
7. Apparatus according to any one of claims 1 to 5 wherein said user control interface includes a touch screen for use as an interactive graphic user interface.
8. Apparatus according to any one of claims 1 to 7 wherein the pre-filled cassette contains an administration ready liquid drug for immediate administration to a patient.
9. Apparatus according to any one of claims 1 to 7 wherein the pre-filled cassette contains liquid contents for injecting into a drug vial for forming a liquid drug in the drug vial for aspiration into the cassette for administration to a patient.
10. A cassette for use with electronic autoinjector apparatus according to any one of claims 1 to 9.
PCT/IL2012/050441 2011-11-06 2012-11-05 Electronic autoinjector apparatus and cassettes for use therewith WO2013065055A1 (en)

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IL216158A IL216158A0 (en) 2011-11-06 2011-11-06 Electronic autoinjector apparatus and cassettes for use therewith
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