WO2002058766A1 - Pen-type injector having an electronic control unit - Google Patents

Pen-type injector having an electronic control unit Download PDF

Info

Publication number
WO2002058766A1
WO2002058766A1 PCT/GB2001/005693 GB0105693W WO02058766A1 WO 2002058766 A1 WO2002058766 A1 WO 2002058766A1 GB 0105693 W GB0105693 W GB 0105693W WO 02058766 A1 WO02058766 A1 WO 02058766A1
Authority
WO
WIPO (PCT)
Prior art keywords
control unit
electronic control
injection device
dose
button
Prior art date
Application number
PCT/GB2001/005693
Other languages
French (fr)
Inventor
Christopher Nigel Langley
Shane Alistair Day
Robert Frederick Veasey
Robert Woolston
Original Assignee
Dca Design International Limited
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=9905751&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2002058766(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to CA2430914A priority Critical patent/CA2430914C/en
Priority to EP01273458A priority patent/EP1349595B1/en
Priority to DE60112326T priority patent/DE60112326T2/en
Priority to US10/433,643 priority patent/US8128603B2/en
Priority to AT01273458T priority patent/ATE300324T1/en
Priority to BRPI0116277-2A priority patent/BR0116277B1/en
Priority to KR1020037008253A priority patent/KR100788314B1/en
Application filed by Dca Design International Limited filed Critical Dca Design International Limited
Priority to MXPA03005589A priority patent/MXPA03005589A/en
Priority to AU2002217283A priority patent/AU2002217283B2/en
Priority to JP2002559097A priority patent/JP4287148B2/en
Priority to IL15623801A priority patent/IL156238A0/en
Publication of WO2002058766A1 publication Critical patent/WO2002058766A1/en
Priority to IL156238A priority patent/IL156238A/en
Priority to HK04102497A priority patent/HK1059583A1/en

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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • 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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir for receiving a piston rod of the pump
    • 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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
    • 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
    • A61M2205/21—General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • A61M2205/215—Tilt detection, e.g. for warning or shut-off
    • 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
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/6018—General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • 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
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525—Dosing
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00—Surgery
    • Y10S128/01—Motorized syringe

Definitions

  • the present invention relates to improvements in an injection device, and in particular to improvements in a portable injection device for dispensing controlled quantities of a medicament.
  • injection devices are used by those suffering from diabetes to administer a dose of insulin or insulin-type medicine to themselves. It will be understood that such injection devices are suitable for the injection of other medicines.
  • pen-type injectors To overcome these difficulties a number of so-called pen-type injectors have been developed. These devices are small, being capable of being carried in a jacket pocket or the like and allow a number of doses to be obtained from a cartridge or ampoule contained within the injector. The present invention has particular application to such pen-type injectors.
  • Figure 2 shows a similar view to Figure 1 with an end cap of the injector omitted;
  • Figure 3 shows a cross-sectional view of the injector of Figures 1 and 2; and
  • Figure 3 A shows a view similar to that of Figure 3 with a filled cartridge in the injector.
  • the injector 2 comprises a main housing 4 to which is releasably secured an end cap or cover 6.
  • a control panel region 8 At a first end of the main housing 4 there is provided a control panel region 8.
  • This region includes a display panel 10, typically a LCD display, and a first dose button 12 and a second dose button 14, the first and second dose buttons being operated to increase or decrease a dose of medicament to be delivered.
  • the control panel region 10 in the illustrated embodiment also includes an arm button 16.
  • a dispense button 18 At the first end of the main housing there is also provided a dispense button 18. Preferably, when not depressed, the dispense button 18 is flush with the main housing 4.
  • each side of the control panel region 10 are provided a number of grooves or recesses 20. These aid in the gripping of the injector 2 by a user.
  • a needle unit 22 is releasably secured to the main housing.
  • the second end of the main housing 4 is also provided with a shaped portion 24.
  • a cartridge 40 or ampoule of medicament is stored in the housing 4 behind the shaped portion 24.
  • the shaped portion is transparent to permit the cartridge 40 to be seen by a user.
  • a prime button 26 is also provided on the second end of the housing 4. It will be understood that when the end cap 6 is in place over the second end of the housing, it will not be possible inadvertently to depress the prime button 26 or to be pricked by the needle unit 22.
  • a cover detection switch 28 may also be included at the second end of the main housing 4 to detect whether the end cap or cover 6 is in place or not.
  • FIG. 3 there can be seen a priming contact 30, an arm contact 32, a first dose contact 34 and a second dose contact 36 corresponding to the respective buttons.
  • a dispense contact 19 corresponding to the dispense button 18 is also shown.
  • a suitable location for a power source 38 such as a battery or batteries.
  • a suitable region in which a cartridge 40 or ampoule of medicament is to be located This region may be accessed by way of the removable shaped portion 24 of the main housing 4 to allow for replacement of the cartridge 40 or ampoule as required by the user.
  • a drive mechanism 42 which operates from the power source 38 and acts upon the cartridge 40 or ampoule of medicament.
  • the cartridge 40 or ampoule comprises a container 44 or sleeve closed at one end by a cover 46 at a head end thereof, and sealed at the other by a movable bung 48 or stopper.
  • the needle unit 22 pierces the cover 46 and movement of the bung 48 towards the cover 46 will cause the medicament contained within the cartridge 40 or ampoule to be expelled.
  • the cartridge may be a 3ml cartridge in accordance with ISO/FDIS 11608 Part 3, or any other suitable cartridge to suit the injector.
  • Movement of the bung 48 or stopper is caused by movement of a piston or plunger 50 forming a part of the drive mechanism 42.
  • the piston or plunger 50 is movable between a first fully withdrawn position (not shown) which allows for the replacement of the cartridge 40 or ampoule and a second fully extended portion in which as much medicament as possible has been expelled from the cartridge 40 or ampoule.
  • An end stop switch 52 may be provided in the main housing 4 to detect when the piston 50 is in the fully withdrawn position. Tripping of the switch end stop 52 may release a catch or other fastening device to allow access to the main housing 4 for replacement of the cartridge 40.
  • the drive mechanism 42 is operated by a motor 54 under the control of an electronic control unit (not shown).
  • the motor 54 should be reversible in order ,to allow the piston 50 to be moved between the first and second positions.
  • the motor 54 can be seen to drive the piston 50 by way of a gear train 42, such that rotation of a third rotor 58 causes the piston 50 to be moved in relation to the third rotor 58.
  • the user can feel the vibration of the motor 54 and the associated drive mechanism 42 and/or hear them in operation. In this way an added degree of confidence in the fact of the operation of the injector 2 is provided to the user.
  • the injector 2 is provided with an electronic control unit.
  • the electronic control unit is coupled both to the drive mechanism and a user interface.
  • the user interface includes the display panel 10 as well as the user operable buttons (and associated contacts).
  • the electronic control unit is microprocessor based. Either volatile or non-volatile memory may be used for storage of 'dose history' and patient specific information. It will be understood that depression of the user operated buttons will cause associated signals to be sent to the electronic control unit, that is when the prime button 26 is depressed a prime signal will be sent to the electronic control unit.
  • the electronic control unit is preferably powered from the injector power source 38.
  • the injector 2 preferably also includes a port for communication between the electronic control unit and an external apparatus such as a personal computer.
  • the injector 2 also has a priming detection facility, (such as a tilt switch or accelerometer) to identify when the injector 2 is inverted. On detection of an inverted position (needle up) the injector 2 will automatically change state to be ready for priming. Priming may be initiated by depression of the prime button 26 to cause a fixed small dispense action. The electronic control unit may cause a speaker to sound when the prime button 26 is depressed.
  • a priming detection facility such as a tilt switch or accelerometer
  • the prime button 26 is inactive at all other times. When the prime button 26 is active, all other buttons in the control panel region are inactive, that is those buttons which are to be used to set or dispense a dose. In other words, when the prime button 26 is active, the electronic control unit or processor will only actuate the drive mechanism 42 to cause a fixed small dispense action
  • the electronic control unit may cause a speaker to sound when the arm button 16 is depressed for a sufficient period of time to provide audible feedback for the user.
  • the function of the arm button 16 is to make the dose button 18 active.
  • the arm button is preferably held down for a predetermined period of time before the injector 2 becomes armed.
  • the armed status may additionally be shown on the display panel 10.
  • the functionality of the arm button is preferably linked to the cover detection switch 28 such that the arm button 16 will only function to arm the injector 2 when the cover 6 is not present.
  • a clock within the electronic control unit will detect whether the dose button 18 has been pressed within a specified time interval following arming of the injector 2. If the dose button 18 has not been depressed within the specified time interval the electronic control unit will disarm the injector 2. Alternatively, if the arm button is depressed a second time within a predetermined time period by the user, the injector will be disabled.
  • the dose button 18 may function as both a prime button and the dose button.
  • the priming detector is actuated, by the injector 2 being oriented needle up, the dose button 18 would change function to that of the prime button of the previous embodiment.
  • buttons of the injector 2 are preferably tactile in nature to provide sensory feedback to the user.
  • the display panel 10 is typically an LCD display and will provide alphanumeric and graphical information relating to the operation of the device.
  • the display panel 10 preferably indicates the selected dose quantity, the previous dose quantity and the time elapsed since the previous dose was administered.
  • the time elapsed since the previous dose is limited to a time period within the preceding 48 hours, though other time periods are possible.
  • Additional information which may be displayed includes:
  • the quantity of medicament remaining in the cartridge preferably in terms of dosage units of the medicament. - that the device is in the priming position (either in addition to or instead of the acoustic indication noted above)
  • the speaker volume setting for example high, low or muted.
  • the injector is nearing the end of its life (for example a battery power level indication - graphical or countdown in terms of the number of days or complete operating cycles to a predetermined expiry of the product life - alphanumeric).
  • the dose selected is the maximum available in the cartridge 40 - that the maximum dose available is less than the dose expected.
  • the display panel 10 may offer a user a choice of language options as appropriate for the market and/or user.
  • the text displayed may include that noted above and/or further information.
  • the language option may be pre-programmed or selectable by a user.
  • the user may preferably select the language option by means of a menu provided on the display panel 10.
  • the currently selected dose value, the previously used dose value and the time (in hours) since the previous dose was dispensed, may all be shown clearly at the same time, in large, easy-to-read characters on the display.
  • the display is also provided with a backlight.
  • the display 10 preferably provides a graphical indication that the selected dose is being dispensed. This may be achieved, for example, as either an animated graphic or a countdown (or a combination of both).
  • the control buttons have a number of functions.
  • the dose buttons 12,14 allow a user to select a desired dosage.
  • the dose arm button 16 allows a user to confirm selection of a desired dosage.
  • the first dose button can increment the dosage level and the second dose button can decrement the dosage level.
  • the dose dialling buttons 12,14 may be pressed down (and held for a short time, 1-2 seconds) to re-set a dose value to zero. The user can then dial up (or down) in single (or half) increments.
  • the dose dialling buttons 12,14 are intended to be pressed once for a single (or half) increment in the selected dose value. In an alternative embodiment, pressing and holding one of the buttons will cause the dose value to start to scroll (up or down) in order to change the dose size more rapidly.
  • the dispense button 18 allows a user to initiate dispensing of the dosage.
  • the primer button 26 dispenses a unit of dosage from the cartridge 40. Thus, if any air is trapped in the injector 2 this can be expelled by use of the prime button 26. A door release catch is provided to allow access to the cartridge 40.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Primary Health Care (AREA)
  • Epidemiology (AREA)
  • Medical Informatics (AREA)
  • Medicinal Chemistry (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Fuel-Injection Apparatus (AREA)
  • Read Only Memory (AREA)
  • External Artificial Organs (AREA)
  • Knitting Machines (AREA)
  • Electrical Control Of Air Or Fuel Supplied To Internal-Combustion Engine (AREA)
  • Apparatus For Radiation Diagnosis (AREA)
  • Coating Apparatus (AREA)
  • Electrophonic Musical Instruments (AREA)
  • Diaphragms For Electromechanical Transducers (AREA)
  • Chemical Or Physical Treatment Of Fibers (AREA)
  • Polarising Elements (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Vehicle Body Suspensions (AREA)
  • Valve Device For Special Equipments (AREA)
  • Seal Device For Vehicle (AREA)
  • Elimination Of Static Electricity (AREA)
  • Loading And Unloading Of Fuel Tanks Or Ships (AREA)
  • Catching Or Destruction (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Electrostatic Spraying Apparatus (AREA)
  • Coloring Foods And Improving Nutritive Qualities (AREA)

Abstract

An injection device of the kind having a main housing (4) is disclosed and includes a drive mechanism (42) to expel selectively a dose of medicament from a medicament cartridge (40) through a needle unit (22) and an electronic control unit to control the drive mechanism (42). The injection device further comprises a prime button (26) which causes a prime signal to be sent to the electronic control unit, the electronic control unit actuating the drive mechanism (42) to expel a predetermined small dose of medicament on receipt of the prime signal. In this way removal of entrapped air from the medicament cartridge (40) is obtained.

Description

PEN-TYPE INJECTOR HAVING AN ELECTRONIC CONTROL UNIT
The present invention relates to improvements in an injection device, and in particular to improvements in a portable injection device for dispensing controlled quantities of a medicament.
Typically such injection devices are used by those suffering from diabetes to administer a dose of insulin or insulin-type medicine to themselves. It will be understood that such injection devices are suitable for the injection of other medicines.
At one time, such doses were administered by use of a disposable syringe; the syringe first being filled from a separate phial or other container and then used to inject the dose. However, there were a number of difficulties in such an arrangement. In particular, such an arrangement was not suitable for the infirm. For others, the social stigma associated with such syringes made their public use problematic.
To overcome these difficulties a number of so-called pen-type injectors have been developed. These devices are small, being capable of being carried in a jacket pocket or the like and allow a number of doses to be obtained from a cartridge or ampoule contained within the injector. The present invention has particular application to such pen-type injectors.
While such pen-type injectors are a considerable improvement upon disposable hypodermic syringes, problems nevertheless remain. It is an advantage of the present invention that it eliminates, or at least substantially reduces such problems. The present invention also provides for improved ease of use and improved interaction with a user.
The invention will now be described, by way of example only, with reference to the accompanying drawings; in which:- Figure 1 shows a plan view of a pen-type injector in accordance with the present invention;
Figure 2 shows a similar view to Figure 1 with an end cap of the injector omitted; Figure 3 shows a cross-sectional view of the injector of Figures 1 and 2; and Figure 3 A shows a view similar to that of Figure 3 with a filled cartridge in the injector.
Referring first to Figures 1 to 3, there can be seen a pen-type injector 2 in accordance with the present invention. The injector 2 comprises a main housing 4 to which is releasably secured an end cap or cover 6.
At a first end of the main housing 4 there is provided a control panel region 8. This region includes a display panel 10, typically a LCD display, and a first dose button 12 and a second dose button 14, the first and second dose buttons being operated to increase or decrease a dose of medicament to be delivered. The control panel region 10 in the illustrated embodiment also includes an arm button 16.
At the first end of the main housing there is also provided a dispense button 18. Preferably, when not depressed, the dispense button 18 is flush with the main housing 4.
Along a longitudinal axis of the injector 2, to each side of the control panel region 10 are provided a number of grooves or recesses 20. These aid in the gripping of the injector 2 by a user.
At a second end of the main housing 4 a needle unit 22 is releasably secured to the main housing. The second end of the main housing 4 is also provided with a shaped portion 24.
In use a cartridge 40 or ampoule of medicament is stored in the housing 4 behind the shaped portion 24. For preference, the shaped portion is transparent to permit the cartridge 40 to be seen by a user. A prime button 26 is also provided on the second end of the housing 4. It will be understood that when the end cap 6 is in place over the second end of the housing, it will not be possible inadvertently to depress the prime button 26 or to be pricked by the needle unit 22. A cover detection switch 28 may also be included at the second end of the main housing 4 to detect whether the end cap or cover 6 is in place or not.
In Figure 3, there can be seen a priming contact 30, an arm contact 32, a first dose contact 34 and a second dose contact 36 corresponding to the respective buttons. A dispense contact 19 corresponding to the dispense button 18 is also shown. ,
With reference to Figure 3 it may be seen that there is provided a suitable location for a power source 38 such as a battery or batteries. There is also a suitable region in which a cartridge 40 or ampoule of medicament is to be located. This region may be accessed by way of the removable shaped portion 24 of the main housing 4 to allow for replacement of the cartridge 40 or ampoule as required by the user.
In a third region of the main housing 4 there is provided a drive mechanism 42 which operates from the power source 38 and acts upon the cartridge 40 or ampoule of medicament.
The cartridge 40 or ampoule comprises a container 44 or sleeve closed at one end by a cover 46 at a head end thereof, and sealed at the other by a movable bung 48 or stopper. When in position, the needle unit 22 pierces the cover 46 and movement of the bung 48 towards the cover 46 will cause the medicament contained within the cartridge 40 or ampoule to be expelled. The cartridge may be a 3ml cartridge in accordance with ISO/FDIS 11608 Part 3, or any other suitable cartridge to suit the injector.
Movement of the bung 48 or stopper is caused by movement of a piston or plunger 50 forming a part of the drive mechanism 42. The piston or plunger 50 is movable between a first fully withdrawn position (not shown) which allows for the replacement of the cartridge 40 or ampoule and a second fully extended portion in which as much medicament as possible has been expelled from the cartridge 40 or ampoule. An end stop switch 52 may be provided in the main housing 4 to detect when the piston 50 is in the fully withdrawn position. Tripping of the switch end stop 52 may release a catch or other fastening device to allow access to the main housing 4 for replacement of the cartridge 40.
The drive mechanism 42 is operated by a motor 54 under the control of an electronic control unit (not shown). The motor 54 should be reversible in order ,to allow the piston 50 to be moved between the first and second positions. In Figure 3, the motor 54 can be seen to drive the piston 50 by way of a gear train 42, such that rotation of a third rotor 58 causes the piston 50 to be moved in relation to the third rotor 58.
Preferably, the user can feel the vibration of the motor 54 and the associated drive mechanism 42 and/or hear them in operation. In this way an added degree of confidence in the fact of the operation of the injector 2 is provided to the user.
The functionality of a pen-type injector in accordance with the present invention will now be described, in particular with reference to Figures 1, 2 and 3.
The injector 2 is provided with an electronic control unit. The electronic control unit is coupled both to the drive mechanism and a user interface. The user interface includes the display panel 10 as well as the user operable buttons (and associated contacts). The electronic control unit is microprocessor based. Either volatile or non-volatile memory may be used for storage of 'dose history' and patient specific information. It will be understood that depression of the user operated buttons will cause associated signals to be sent to the electronic control unit, that is when the prime button 26 is depressed a prime signal will be sent to the electronic control unit. The electronic control unit is preferably powered from the injector power source 38.
The injector 2 preferably also includes a port for communication between the electronic control unit and an external apparatus such as a personal computer.
The injector 2 also has a priming detection facility, (such as a tilt switch or accelerometer) to identify when the injector 2 is inverted. On detection of an inverted position (needle up) the injector 2 will automatically change state to be ready for priming. Priming may be initiated by depression of the prime button 26 to cause a fixed small dispense action. The electronic control unit may cause a speaker to sound when the prime button 26 is depressed.
The prime button 26 is inactive at all other times. When the prime button 26 is active, all other buttons in the control panel region are inactive, that is those buttons which are to be used to set or dispense a dose. In other words, when the prime button 26 is active, the electronic control unit or processor will only actuate the drive mechanism 42 to cause a fixed small dispense action
The electronic control unit may cause a speaker to sound when the arm button 16 is depressed for a sufficient period of time to provide audible feedback for the user.
The function of the arm button 16 is to make the dose button 18 active. The arm button is preferably held down for a predetermined period of time before the injector 2 becomes armed. The armed status may additionally be shown on the display panel 10. The functionality of the arm button is preferably linked to the cover detection switch 28 such that the arm button 16 will only function to arm the injector 2 when the cover 6 is not present.
Additionally, in a preferred embodiment, a clock within the electronic control unit will detect whether the dose button 18 has been pressed within a specified time interval following arming of the injector 2. If the dose button 18 has not been depressed within the specified time interval the electronic control unit will disarm the injector 2. Alternatively, if the arm button is depressed a second time within a predetermined time period by the user, the injector will be disabled.
In an alternative embodiment, the dose button 18 may function as both a prime button and the dose button. When the priming detector is actuated, by the injector 2 being oriented needle up, the dose button 18 would change function to that of the prime button of the previous embodiment.
The buttons of the injector 2 are preferably tactile in nature to provide sensory feedback to the user.
The display panel 10 is typically an LCD display and will provide alphanumeric and graphical information relating to the operation of the device. The display panel 10 preferably indicates the selected dose quantity, the previous dose quantity and the time elapsed since the previous dose was administered. Typically, the time elapsed since the previous dose is limited to a time period within the preceding 48 hours, though other time periods are possible.
Additional information which may be displayed includes:
- that the injector is armed and ready to dispense (graphical)
- that the injector is dispensing (graphical)
- that the injector has dispensed the selected dose and that a user should wait before removing the needle from their body
- that this waiting period has elapsed
- the dose history, typically for the last 48 hours, in terms of the dosage taken and the elapsed time between doses
- the quantity of medicament remaining in the cartridge, preferably in terms of dosage units of the medicament. - that the device is in the priming position (either in addition to or instead of the acoustic indication noted above)
- the speaker volume setting, for example high, low or muted.
- that the injector is nearing the end of its life (for example a battery power level indication - graphical or countdown in terms of the number of days or complete operating cycles to a predetermined expiry of the product life - alphanumeric).
- that the needle is probably blocked
- that replacement of the cartridge 40 is in progress
- that the dose selected is the maximum available in the cartridge 40 - that the maximum dose available is less than the dose expected.
The display panel 10 may offer a user a choice of language options as appropriate for the market and/or user. The text displayed may include that noted above and/or further information. The language option may be pre-programmed or selectable by a user. The user may preferably select the language option by means of a menu provided on the display panel 10.
The currently selected dose value, the previously used dose value and the time (in hours) since the previous dose was dispensed, may all be shown clearly at the same time, in large, easy-to-read characters on the display. Preferably, the display is also provided with a backlight.
The display 10 preferably provides a graphical indication that the selected dose is being dispensed. This may be achieved, for example, as either an animated graphic or a countdown (or a combination of both).
The control buttons have a number of functions. The dose buttons 12,14 allow a user to select a desired dosage. The dose arm button 16 allows a user to confirm selection of a desired dosage. The first dose button can increment the dosage level and the second dose button can decrement the dosage level. The dose dialling buttons 12,14 may be pressed down (and held for a short time, 1-2 seconds) to re-set a dose value to zero. The user can then dial up (or down) in single (or half) increments.
The dose dialling buttons 12,14 are intended to be pressed once for a single (or half) increment in the selected dose value. In an alternative embodiment, pressing and holding one of the buttons will cause the dose value to start to scroll (up or down) in order to change the dose size more rapidly.
The dispense button 18 allows a user to initiate dispensing of the dosage. The primer button 26 dispenses a unit of dosage from the cartridge 40. Thus, if any air is trapped in the injector 2 this can be expelled by use of the prime button 26. A door release catch is provided to allow access to the cartridge 40.

Claims

1 An injection device of the kind having a main housing 4 including a drive mechanism 42 to expel selectively a dose of medicament from a medicament cartridge 40 through a needle unit 22 and an electronic control unit to control the drive mechanism 42 characterised in that the injection device further comprises a prime button 26 which causes a prime signal to be sent to the electronic control unit, the electronic control unit actuating the drive mechanism 42 to expel a predetermined small dose of medicament on receipt of the prime signal.
2 An injection device according to claim 1, characterised in that the injection device further comprises a cover 6 adapted to cover the needle unit 22 and a part of the main housing 4, characterised in that the prime button 26 is located within the part of the main housing 4 adapted to be covered by the cover.
3 An injection device according to claim 1 or claim 2, characterised in that the injection device further comprises a priming detection means to sense the orientation of the injection device, characterised in that the electronic control unit will only cause the drive mechanism to operate in response to a priming signal when the injection device is in a predetermined orientation.
4 An injection device according to claim 3, characterised in that the injection device comprises further buttons 12,14,18 which may in use generate further signals to which the electronic control unit may respond, the electronic control unit not responding to said further signals when the injection device is in the predetermined orientation.
PCT/GB2001/005693 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit WO2002058766A1 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
IL15623801A IL156238A0 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
KR1020037008253A KR100788314B1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
DE60112326T DE60112326T2 (en) 2000-12-22 2001-12-21 WRITTEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
US10/433,643 US8128603B2 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
AT01273458T ATE300324T1 (en) 2000-12-22 2001-12-21 PEN-TYPE INJECTOR WITH AN ELECTRONIC CONTROL UNIT
BRPI0116277-2A BR0116277B1 (en) 2000-12-22 2001-12-21 injection device.
MXPA03005589A MXPA03005589A (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit.
CA2430914A CA2430914C (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
EP01273458A EP1349595B1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
AU2002217283A AU2002217283B2 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
JP2002559097A JP4287148B2 (en) 2000-12-22 2001-12-21 Pen-type injection device with electronic control unit
IL156238A IL156238A (en) 2000-12-22 2003-06-01 Pen-type injector having an electronic control unit
HK04102497A HK1059583A1 (en) 2000-12-22 2004-04-08 Pen-type injector having an electronic control unit.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GBGB0031466.6A GB0031466D0 (en) 2000-12-22 2000-12-22 Improvements in and relating to an injection device
GB0031466.6 2000-12-22

Publications (1)

Publication Number Publication Date
WO2002058766A1 true WO2002058766A1 (en) 2002-08-01

Family

ID=9905751

Family Applications (13)

Application Number Title Priority Date Filing Date
PCT/GB2001/005726 WO2002051481A1 (en) 2000-12-22 2001-12-21 Pen-type injector having holding mechanism for medicament cartridge
PCT/GB2001/005741 WO2002051474A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005707 WO2002051476A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005743 WO2002051475A1 (en) 2000-12-22 2001-12-21 Injection device with replaceable cartridge
PCT/GB2001/005712 WO2002051480A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005709 WO2002051477A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005693 WO2002058766A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005747 WO2002058767A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005721 WO2002051473A1 (en) 2000-12-22 2001-12-21 Dosing means for an injection device
PCT/GB2001/005710 WO2002051478A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005711 WO2002051479A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005705 WO2002051472A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005704 WO2002051471A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device

Family Applications Before (6)

Application Number Title Priority Date Filing Date
PCT/GB2001/005726 WO2002051481A1 (en) 2000-12-22 2001-12-21 Pen-type injector having holding mechanism for medicament cartridge
PCT/GB2001/005741 WO2002051474A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005707 WO2002051476A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005743 WO2002051475A1 (en) 2000-12-22 2001-12-21 Injection device with replaceable cartridge
PCT/GB2001/005712 WO2002051480A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005709 WO2002051477A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit

Family Applications After (6)

Application Number Title Priority Date Filing Date
PCT/GB2001/005747 WO2002058767A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005721 WO2002051473A1 (en) 2000-12-22 2001-12-21 Dosing means for an injection device
PCT/GB2001/005710 WO2002051478A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005711 WO2002051479A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005705 WO2002051472A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005704 WO2002051471A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device

Country Status (19)

Country Link
US (13) US20040054328A1 (en)
EP (13) EP1349587B1 (en)
JP (16) JP4308525B2 (en)
KR (13) KR100788319B1 (en)
CN (13) CN1270786C (en)
AT (12) ATE294600T1 (en)
AU (12) AU2002216254B2 (en)
BR (13) BR0116277B1 (en)
CA (13) CA2430935C (en)
CY (3) CY1106128T1 (en)
DE (12) DE60112326T2 (en)
DK (12) DK1353713T3 (en)
ES (12) ES2246289T3 (en)
GB (1) GB0031466D0 (en)
HK (12) HK1059580A1 (en)
IL (22) IL156245A0 (en)
MX (13) MXPA03005584A (en)
PT (12) PT1349592E (en)
WO (13) WO2002051481A1 (en)

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