US20040054328A1 - Pen-type injector having an electronic control unit - Google Patents
Pen-type injector having an electronic control unit Download PDFInfo
- Publication number
- US20040054328A1 US20040054328A1 US10/433,645 US43364503A US2004054328A1 US 20040054328 A1 US20040054328 A1 US 20040054328A1 US 43364503 A US43364503 A US 43364503A US 2004054328 A1 US2004054328 A1 US 2004054328A1
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- United States
- Prior art keywords
- speed
- drive mechanism
- medicament
- control unit
- electronic control
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- 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
- A61M5/178—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
- A61M5/145—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.
- FIG. 1 shows a plan view of a pen-type injector in accordance with the present invention
- FIG. 2 shows a similar view to FIG. 1 with an end cap of the injector omitted;
- FIG. 3 shows a cross-sectional view of the injector of FIGS. 1 and 2;
- FIG. 3A shows a view similar to that of FIG. 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 decease 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 .
- the dispense button 18 is flush with 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 .
- 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 primer 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 primer 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 3 ml 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.
- 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 primer button 26 to cause a fixed small dispense action. The electronic control unit may cause a speaker to sound when the primer button 26 is depressed.
- a priming detection facility such as a tilt switch or accelerometer
- the primer button 26 is inactive at all other times. When the primer 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.
- 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 dispense 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 dispense button 18 has been pressed within a specified time interval following arming of the injector 2 . If the dispense button 18 has not been depressed within the specified time interval the electronic control unit will disarm the injector 2 .
- the injector will be disabled if the arm button is depressed a second time within a predetermined time period by the user.
- 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 dispense 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 injector is dispensing (graphical)
- 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.
- 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 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 primer button 26 .
- a door release catch is provided to allow access to the cartridge 40 .
- the injector 2 may also be provided with an audible alarm, such as a piezo-electric sounder or an electronically-operated sounder.
- the device may have a switch or means of setting the volume level of the sounder and/or to turn it off. This may be used to provide an acoustic confirmation of depression of one or more of the buttons, as an alarm indicator to warn the user that there is a limited quantity of medicament in the cartridge 40 , as an alarm indicator to warn a user that the injector is nearing the end of its life (battery drainage indicator), to indicate that the desired dosage has been delivered and that a predetermined time has elapsed since completion of a dispense operation and a user is now free to withdraw the needle and/or other conditions as may be required.
- the acoustic signal may be provided in addition to a visual signal provided on the display panel 10 and in addition to any feedback provided by the tactile nature of the buttons.
- each cartridge 40 will be emptied by an identical travel of the plunger driven by the drive mechanism. Once the plunger 50 is in the fully extended position, the cartridge 40 is known to be empty and an indication of this will be provided to the user.
- the electronic control unit advances the lead screw 60 until the plunger 50 strikes the cartridge bung 48 .
- a micro-switch 51 such as a dome contact switch
- a number of units of medicament stored within the cartridge 40 can be determined.
- a half empty or incorrectly filled cartridge 40 may be used with the injector 2 of the present invention.
- the electronic control unit having determined the number of units stored within the cartridge preferably will not allow a dosage larger than that remaining to be dialled up for dispense.
- user interface software as part of the electronic control unit can aid the user to split the required dose across a cartridge changeover. For example, if the user is due to take a thirty unit dose but only twenty units remain in the injector 2 , then the user can dispense the twenty units, replace the cartridge 40 and the injector 2 will automatically offer the user ten units as the ‘outstanding balance’ from the first dose. If the user does not take the ‘outstanding balance’ (or other dose size) within a prescribed time, then the injector 2 will revert to the normal display status. In such a case, the injector history may record a ‘split dose’ as a single dose (being the total of the split doses) so long as the doses are taken within a prescribed time. Alternatively, the user may choose to take the first part of the dose and then cancel the second part of the dose rather than rely upon the time out feature described above. This action will be recorded as part of the injector history information.
- a ‘dose interrupt’ function may also be provided for such that the user can stop (and re-start) the dispense action. This may be useful if the injection becomes painful or if the user wishes to select a large dose, but would like to deliver the dose split between two sites on his/her body.
- the dose button is pressed to start, then pressed to stop, then pressed to re-start, and so on.
- the dose button may be pressed and held down to dispense, then released to stop, then pressed and held down to re-start.
- the drive mechanism 42 preferably operates at a constant speed during dispense. However, at the start of each new cartridge 40 a slower speed may be appropriate to increase the force available to overcome stiction of the bung 48 in the cartridge 40 . Alternatively, the speed of dispense may be controlled to suit the comfort of the user.
- the drive mechanism may be able to operate at a variable speed.
- the injector 2 will be adapted to detect resistance to dispensing, for example if the medicament, i.e. insulin, is cold it may become more viscous and so provide greater resistance to dispense.
- the drive mechanism can then slow to deliver more output force and then stop if this has no effect upon the effective dispense action.
- the electronic control unit will switch off the drive mechanism, and thus not dispense, rather than seek to dispense further medicament.
- the dispense action is initiated by the user operating a switch. This means that the force required to operate the dispense button can be optimised for the comfort and ergonomic requirement of users.
- the drive mechanism 42 may additionally comprise a 1 bit encoder (for example an inductive transducer mounted at a first stage in the gear train 56 ) to detect slipping of the motor. Thus, should the drive mechanism 42 become jammed, this can be detected, the electronic control unit can halt the drive mechanism 42 and indicate to the user that an error has occurred.
- a 1 bit encoder for example an inductive transducer mounted at a first stage in the gear train 56
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- Fuel-Injection Apparatus (AREA)
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- Electrical Control Of Air Or Fuel Supplied To Internal-Combustion Engine (AREA)
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Abstract
An injection device for injection of a medicament from a medicament cartridge, the medicament cartridge (40) having a bung (48) displaceable within the medicament cartridge (40) to cause medicament to be expelled from the medicament cartridge (40) is disclosed. The injection device comprises a drive mechanism (42) for selectively acting on the bung (48) to dispense the medicament from the medicament cartridge (40) and an electronic control unit for controlling operation of the drive mechanism (42). Under the control of the electronic control unit the drive mechanism (42) initially acts at first speed and at a second speed thereafter.
Description
- 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 ajacket 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:
- FIG. 1 shows a plan view of a pen-type injector in accordance with the present invention;
- FIG. 2 shows a similar view to FIG. 1 with an end cap of the injector omitted;
- FIG. 3 shows a cross-sectional view of the injector of FIGS. 1 and 2; and
- FIG. 3A shows a view similar to that of FIG. 3 with a filled cartridge in the injector.
- Referring first to FIGS.1 to 3, there can be seen a pen-
type injector 2 in accordance with the present invention. Theinjector 2 comprises amain housing 4 to which is releasably secured an end cap orcover 6. - At a first end of the
main housing 4 there is provided acontrol panel region 8. This region includes a display panel10, typically a LCD display, and afirst dose button 12 and asecond dose button 14, the first and second dose buttons being operated to increase or decease a dose of medicament to be delivered. Thecontrol panel region 10 in the illustrated embodiment also includes anarm button 16. - At the first end of the main housing there is also provided a
dispense button 18. Preferably, when not depressed, thedispense button 18 is flush with themain housing 4. - Along a longitudinal axis of the
injector 2, to each side of thecontrol panel region 10 are provided a number of grooves orrecesses 20. These aid in the gripping of theinjector 2 by a user. - At a second end of the main housing4 a
needle unit 22 is releasably secured to the main housing. The second end of themain housing 4 is also provided with ashaped portion 24. - In use a
cartridge 40 or ampoule of medicament is stored in thehousing 4 behind theshaped portion 24. For preference, the shaped portion is transparent to permit thecartridge 40 to be seen by a user. - A
primer button 26 is also provided on the second end of thehousing 4. It will be understood that when theend cap 6 is in place over the second end of the housing, it will not be possible inadvertently to depress theprimer button 26 or to be pricked by theneedle unit 22. Acover detection switch 28 may also be included at the second end of themain housing 4 to detect whether the end cap orcover 6 is in place or not. - In FIG. 3, there can be seen a
priming contact 30, anarm contact 32, afirst dose contact 34 and asecond dose contact 36 corresponding to the respective buttons. Adispense contact 19 corresponding to thedispense button 18 is also shown. - With reference to FIG. 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 acartridge 40 or ampoule of medicament is to be located. This region may be accessed by way of the removableshaped portion 24 of themain housing 4 to allow for replacement of thecartridge 40 or ampoule as required by the user. - In a third region of the
main housing 4 there is provided adrive mechanism 42 which operates from thepower source 38 and acts upon thecartridge 40 or ampoule of medicament. - The
cartridge 40 or ampoule comprises acontainer 44 or sleeve closed at one end by acover 46 at a head end thereof, and sealed at the other by amovable bung 48 or stopper. When in position, theneedle unit 22 pierces thecover 46 and movement of thebung 48 towards thecover 46 will cause the medicament contained within thecartridge 40 or ampoule to be expelled. The cartridge may be a 3 ml 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 orplunger 50 forming a part of thedrive mechanism 42. The piston orplunger 50 is movable between a first fully withdrawn position (not shown) which allows for the replacement of thecartridge 40 or ampoule and a second fully extended portion in which as much medicament as possible has been expelled from thecartridge 40 or ampoule. Anend stop switch 52 may be provided in themain housing 4 to detect when thepiston 50 is in the fully withdrawn position. Tripping of theswitch end stop 52 may release a catch or other fastening device to allow access to themain housing 4 for replacement of thecartridge 40. - The
drive mechanism 42 is operated by amotor 54 under the control of an electronic control unit (not shown). Themotor 54 should be reversible in order to allow thepiston 50 to be moved between the first and second positions. In FIG. 3, themotor 54 can be seen to drive thepiston 50 by way of agear train 42, such that rotation of athird rotor 58 causes thepiston 50 to be moved in relation to thethird rotor 58. - Preferably, the user can feel the vibration of the
motor 54 and the associateddrive mechanism 42 and/or hear them in operation. In this way an added degree of confidence in the fact of the operation of theinjector 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 FIGS. 1, 2 and3.
- 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 thedisplay 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. - 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 theinjector 2 is inverted. On detection of an inverted position (needle up) theinjector 2 will automatically change state to be ready for priming. Priming may be initiated by depression of theprimer button 26 to cause a fixed small dispense action. The electronic control unit may cause a speaker to sound when theprimer button 26 is depressed. - The
primer button 26 is inactive at all other times. When theprimer 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. - 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 dispensebutton 18 active. The arm button is preferably held down for a predetermined period of time before theinjector 2 becomes armed. The armed status may additionally be shown on thedisplay panel 10. The functionality of the arm button is preferably linked to thecover detection switch 28 such that thearm button 16 will only function to arm theinjector 2 when thecover 6 is not present. - Additionally, in a preferred embodiment, a clock within the electronic control unit will detect whether the dispense
button 18 has been pressed within a specified time interval following arming of theinjector 2. If the dispensebutton 18 has not been depressed within the specified time interval the electronic control unit will disarm theinjector 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 button18 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 dispensebutton 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. Thedisplay 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 last48 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 thedisplay 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 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. Thedose dialling buttons - The
dose dialling buttons - The dispense
button 18 allows a user to initiate dispensing of the dosage. Theprimer button 26 dispenses a unit of dosage from thecartridge 40. Thus, if any air is trapped in theinjector 2 this can be expelled by use of theprimer button 26. A door release catch is provided to allow access to thecartridge 40. - The
injector 2 may also be provided with an audible alarm, such as a piezo-electric sounder or an electronically-operated sounder. The device may have a switch or means of setting the volume level of the sounder and/or to turn it off. This may be used to provide an acoustic confirmation of depression of one or more of the buttons, as an alarm indicator to warn the user that there is a limited quantity of medicament in thecartridge 40, as an alarm indicator to warn a user that the injector is nearing the end of its life (battery drainage indicator), to indicate that the desired dosage has been delivered and that a predetermined time has elapsed since completion of a dispense operation and a user is now free to withdraw the needle and/or other conditions as may be required. The acoustic signal may be provided in addition to a visual signal provided on thedisplay panel 10 and in addition to any feedback provided by the tactile nature of the buttons. - Since the
cartridge 40 is of a standard size, eachcartridge 40 will be emptied by an identical travel of the plunger driven by the drive mechanism. Once theplunger 50 is in the fully extended position, thecartridge 40 is known to be empty and an indication of this will be provided to the user. - When the door release catch is operated for the emptied
cartridge 40 to be removed thedrive mechanism 42 is operated to reverse alead screw 60 to withdraw theplunger 50 until thelead screw 60 strikes theend stop switch 52 which is provided at a known reference point. - When a
new cartridge 40 is detected, for example by way of a contact switch (not shown), and the door release catch closed, the electronic control unit advances thelead screw 60 until theplunger 50 strikes thecartridge bung 48. This may conveniently be done by fitting a micro-switch 51, such as a dome contact switch to a free end of theplunger 50. - Since the exact position of the bung48 can be calculated with reference to the
rear end stop 52, a number of units of medicament stored within thecartridge 40 can be determined. Thus a half empty or incorrectly filledcartridge 40 may be used with theinjector 2 of the present invention. The electronic control unit having determined the number of units stored within the cartridge preferably will not allow a dosage larger than that remaining to be dialled up for dispense. - Alternatively, user interface software as part of the electronic control unit can aid the user to split the required dose across a cartridge changeover. For example, if the user is due to take a thirty unit dose but only twenty units remain in the
injector 2, then the user can dispense the twenty units, replace thecartridge 40 and theinjector 2 will automatically offer the user ten units as the ‘outstanding balance’ from the first dose. If the user does not take the ‘outstanding balance’ (or other dose size) within a prescribed time, then theinjector 2 will revert to the normal display status. In such a case, the injector history may record a ‘split dose’ as a single dose (being the total of the split doses) so long as the doses are taken within a prescribed time. Alternatively, the user may choose to take the first part of the dose and then cancel the second part of the dose rather than rely upon the time out feature described above. This action will be recorded as part of the injector history information. - A ‘dose interrupt’ function may also be provided for such that the user can stop (and re-start) the dispense action. This may be useful if the injection becomes painful or if the user wishes to select a large dose, but would like to deliver the dose split between two sites on his/her body. In a first embodiment, the dose button is pressed to start, then pressed to stop, then pressed to re-start, and so on. Alternatively, the dose button may be pressed and held down to dispense, then released to stop, then pressed and held down to re-start.
- The
drive mechanism 42 preferably operates at a constant speed during dispense. However, at the start of each new cartridge 40 a slower speed may be appropriate to increase the force available to overcome stiction of the bung 48 in thecartridge 40. Alternatively, the speed of dispense may be controlled to suit the comfort of the user. - In addition, the drive mechanism may be able to operate at a variable speed. In such a case, the
injector 2 will be adapted to detect resistance to dispensing, for example if the medicament, i.e. insulin, is cold it may become more viscous and so provide greater resistance to dispense. The drive mechanism can then slow to deliver more output force and then stop if this has no effect upon the effective dispense action. In other words if, for example, the resistance to dispensing is due a mechanical problem in the injector then the electronic control unit will switch off the drive mechanism, and thus not dispense, rather than seek to dispense further medicament. - Due to the use of an electromechanical drive, the dispense action is initiated by the user operating a switch. This means that the force required to operate the dispense button can be optimised for the comfort and ergonomic requirement of users.
- The
drive mechanism 42 may additionally comprise a 1 bit encoder (for example an inductive transducer mounted at a first stage in the gear train 56) to detect slipping of the motor. Thus, should thedrive mechanism 42 become jammed, this can be detected, the electronic control unit can halt thedrive mechanism 42 and indicate to the user that an error has occurred.
Claims (9)
1. An injection device for injection of a medicament from a medicament cartridge, the medicament cartridge 40 having a bung 48 displaceable within the medicament cartridge 40 to cause medicament to be expelled from the medicament cartridge 40, the injection device comprising a drive mechanism 42 for selectively acting on the bung 48 to dispense the medicament from the medicament cartridge 40 and an electronic control unit for controlling operation of the drive mechanism 42 in which the drive mechanism 42 under the control of the electronic control unit initially acts at a first speed and at a second speed thereafter.
2. An injection device according to claim 1 , characterised in that the first speed is slower than the second speed.
3. An injection device according to claim 2 , characterised in that the second speed is controlled by a user of the injection device.
4. An injection device according to claim 1 , in which the device further comprises means to detect resistance to dispense, said means providing a resistance to dispense signal to the electronic control unit, in which the drive mechanism 42, following receipt of the resistance to dispense signal by the electronic control unit, under the control of the electronic control unit, acts at the second speed, the second speed being slower than the first speed.
5. An injection device according to claim 4 , in which when the resistance to dispense signals continue for a predetermined time following the drive mechanism 42 acting at the second speed, the electronic control unit halts the drive mechanism 42.
6. A method of dispensing a dose of medicament from a medicament cartridge within an injection device having a drive mechanism 42 for selectively acting on a bung 48 of the medicament cartridge 40 comprising the steps of causing the drive mechanism 42 to act on the bung 48 at a first speed; and causing the drive mechanism 42 to act on the bung 48 at a second speed thereafter.
7. A method according to claim 6 characterised in that the first speed is slower than the second speed.
8. A method according to claim 7 characterised in that the second speed is controlled by the user of the injection device.
9. A method according to claim 6 , in which the first speed is faster than the second speed.
Applications Claiming Priority (3)
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GB0031466.6 | 2000-12-22 | ||
GBGB0031466.6A GB0031466D0 (en) | 2000-12-22 | 2000-12-22 | Improvements in and relating to an injection device |
PCT/GB2001/005707 WO2002051476A1 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
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US10/433,822 Expired - Lifetime US7081108B2 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having holding mechanism for medicament cartridge |
US10/433,905 Expired - Lifetime US6949082B2 (en) | 2000-12-22 | 2001-12-21 | Dosing means for an injection device |
US10/433,643 Active 2027-09-02 US8128603B2 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
US10/433,646 Active 2026-06-15 US8469922B2 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
US10/433,645 Abandoned US20040054328A1 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
US10/433,642 Active 2027-01-08 US8926553B2 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
US10/433,648 Abandoned US20040097873A1 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having an electronic control unit |
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US10/433,650 Expired - Lifetime US7052484B2 (en) | 2000-12-22 | 2001-12-21 | Drive mechanism for an injection device |
US10/433,806 Expired - Lifetime US6997906B2 (en) | 2000-12-22 | 2001-12-21 | Injection device with replacement cartridge |
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US10/433,822 Expired - Lifetime US7081108B2 (en) | 2000-12-22 | 2001-12-21 | Pen-type injector having holding mechanism for medicament cartridge |
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US10/433,806 Expired - Lifetime US6997906B2 (en) | 2000-12-22 | 2001-12-21 | Injection device with replacement cartridge |
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2003
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2004
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- 2004-04-14 HK HK04102605A patent/HK1059747A1/en not_active IP Right Cessation
- 2004-04-21 HK HK04102785A patent/HK1059902A1/en not_active IP Right Cessation
- 2004-04-21 HK HK04102786A patent/HK1059903A1/en not_active IP Right Cessation
- 2004-04-22 HK HK04102831A patent/HK1059904A1/en not_active IP Right Cessation
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2006
- 2006-07-26 CY CY20061101037T patent/CY1106128T1/en unknown
- 2006-12-20 CY CY20061101821T patent/CY1106295T1/en unknown
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2007
- 2007-04-26 AU AU2007201951A patent/AU2007201951B2/en not_active Ceased
- 2007-05-01 AU AU2007202032A patent/AU2007202032B2/en not_active Ceased
- 2007-06-11 CY CY20071100777T patent/CY1106652T1/en unknown
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2008
- 2008-10-01 JP JP2008256767A patent/JP4955637B2/en not_active Expired - Lifetime
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2009
- 2009-08-14 JP JP2009188006A patent/JP5054739B2/en not_active Expired - Lifetime
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2010
- 2010-11-19 JP JP2010258513A patent/JP5461368B2/en not_active Expired - Lifetime
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Cited By (16)
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US20040073168A1 (en) * | 2002-10-15 | 2004-04-15 | Nippon Shika Yakuhin Co., Ltd. | Electric syringe for dental anesthetic |
US7476216B2 (en) * | 2002-10-15 | 2009-01-13 | Nippon Shika Yakuhin Co., Ltd. | Electric syringe for dental anesthetic |
US20110264046A1 (en) * | 2005-02-21 | 2011-10-27 | Novo Nordisk A/S | Method for Ensuring Constant Speed of a Motor in an Injection Device |
US8382701B2 (en) * | 2005-02-21 | 2013-02-26 | Novo Nordisk A/S | Method for ensuring constant speed of a motor in an injection device |
EP2206529B2 (en) † | 2008-12-18 | 2020-05-27 | Sanofi-Aventis Deutschland GmbH | Medication delivery device and method of manufacturing a medication delivery device |
US20130123685A1 (en) * | 2009-06-03 | 2013-05-16 | Novo Nordisk A/S | Electronically monitored injection device |
US10850031B2 (en) | 2011-05-12 | 2020-12-01 | Bayer Healthcare Llc | Fluid injection system having various systems for controlling an injection procedure |
US10022493B2 (en) | 2011-05-12 | 2018-07-17 | Bayer Healthcare Llc | Fluid injection system having various systems for controlling an injection procedure |
US9526831B2 (en) | 2011-09-12 | 2016-12-27 | Panasonic Healthcare Co., Ltd. | Pharmaceutical injection device |
US11872375B2 (en) | 2012-09-05 | 2024-01-16 | E3D Agricultural Cooperative Association Ltd. | Electronic auto-injection device |
US10155089B2 (en) * | 2013-07-17 | 2018-12-18 | Sanofi | Drug delivery device |
US20160151580A1 (en) * | 2013-07-17 | 2016-06-02 | Sanofi | Drug delivery device |
CN105377335B (en) * | 2013-07-17 | 2020-08-04 | 赛诺菲 | Drug delivery device |
CN105377335A (en) * | 2013-07-17 | 2016-03-02 | 赛诺菲 | Drug delivery device |
CN106080739A (en) * | 2016-06-20 | 2016-11-09 | 山东理工大学 | The controller that a kind of diabetes patient of auxiliary drives |
WO2021251965A1 (en) * | 2020-06-11 | 2021-12-16 | Bioworld Technology, Inc | Automated injection device for administering antigens to animals |
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