WO2002051472A1 - Drive mechanism for an injection device - Google Patents

Drive mechanism for an injection device Download PDF

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Publication number
WO2002051472A1
WO2002051472A1 PCT/GB2001/005705 GB0105705W WO02051472A1 WO 2002051472 A1 WO2002051472 A1 WO 2002051472A1 GB 0105705 W GB0105705 W GB 0105705W WO 02051472 A1 WO02051472 A1 WO 02051472A1
Authority
WO
WIPO (PCT)
Prior art keywords
ratchet
drive
ratchet means
drive mechanism
injector
Prior art date
Application number
PCT/GB2001/005705
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=WO2002051472(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to US10/433,782 priority Critical patent/US7699815B2/en
Priority to IL15624001A priority patent/IL156240A0/en
Priority to AU2002216231A priority patent/AU2002216231B2/en
Priority to BRPI0116296-9A priority patent/BR0116296B1/en
Priority to CA002430920A priority patent/CA2430920C/en
Priority to MXPA03005575A priority patent/MXPA03005575A/en
Priority to JP2002552613A priority patent/JP4308524B2/en
Application filed by Dca Design International Limited filed Critical Dca Design International Limited
Priority to DE60123836T priority patent/DE60123836T2/en
Priority to EP01272093A priority patent/EP1353712B1/en
Priority to DK01272093T priority patent/DK1353712T3/en
Priority to KR1020037008255A priority patent/KR100788316B1/en
Publication of WO2002051472A1 publication Critical patent/WO2002051472A1/en
Priority to IL156240A priority patent/IL156240A/en
Priority to HK04102831A priority patent/HK1059904A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/24Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/145Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/14566Pressure 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/20Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10ICT 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
    • G16H20/17ICT 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588Constructional features or modes of drive mechanisms for piston rods electrically driven
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/21General characteristics of the apparatus insensitive to tilting or inclination, e.g. spill-over prevention
    • A61M2205/215Tilt detection, e.g. for warning or shut-off
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/50General characteristics of the apparatus with microprocessors or computers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/60General characteristics of the apparatus with identification means
    • A61M2205/6018General characteristics of the apparatus with identification means providing set-up signals for the apparatus configuration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/82Internal energy supply devices
    • A61M2205/8206Internal energy supply devices battery-operated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31525Dosing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/315Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533Dosing mechanisms, i.e. setting a dose
    • A61M5/31545Setting modes for dosing
    • A61M5/31546Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
    • YGENERAL 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
    • Y10TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10STECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S128/00Surgery
    • Y10S128/01Motorized 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.
  • the drive system must be accurate and reliable, and at the same time compact and efficient.
  • the drive system must be reliable and robust; being able to function for the life of the product.
  • the drive system must also be intrinsically fail-safe. 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.
  • 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
  • ' Figure 4 shows a schematic view of an alternative drive mechanism for use with an injector in accordance with the invention.
  • 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.
  • 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 hdusing, 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.
  • An alternative cartridge access means is disclosed in relation to Figures 16 to 23.
  • 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 whibh 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. Alternatively, if the arm button is depressed a second time within a predetermined time period by the user, the injector will be disabled.
  • the dispense 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.
  • FIG 4 there is shown a drive mechanism in the form of a rotary solenoid 170 having an output shaft 172.
  • the rotary solenoid typically converts linear push/pull notion to a few degrees (approx. 15°) of rotary motion by way of a spiral ball race within the solenoid.
  • the output shaft 172 engages a first ratchet member 178.
  • the first ratchet member 178 drives a second ratchet member 174 attached to a shaft 180 of a lead screw.
  • the lead screw will be understood to comprise piston means for the advancement of bung 48 within a medicament cartridge 40 within the context of this description.
  • the first and second ratchet members 178,174 are located in a housing 176.
  • the second ratchet member 174 is biassed towards the first ratchet member 178 (here, by a helical spring 182).
  • the first ratchet member 178 is caused to rotate.
  • the nearmost teeth of the first ratchet member 178 move upwards, thereby pushing the corresponding teeth of the second ratchet member 174 away and against the biassing means.
  • the teeth are disposed angularly about the first and second ratchet members 178,174 to correspond to just less than the angular displacement of the output shaft of the rotary solenoid 170.
  • the teeth of the first ratchet member 178 will have indexed to engage the next set of teeth of the second ratchet member 174.
  • the first ratchet member 178 travels in an opposite direction, thereby driving the second ratchet member 174 and the associated shaft 180 of the lead screw.

Abstract

A drive mechanism for an injection device is disclosed in which piston means are selectively driven to expel medicament from within a medicament cartridge. The drive mechanism comprises a drive means (170) associated with a firs ratchet means (178), a second ratchet means (174) associated with the piston means (180), a housing (176), the first ratchet means (178) and the second ratchet means (174) being disposed within the housing (176). The second ratchet means (174) are biassed by biassing means (182) towards the first ratchet means (178). The drive means (170) is actuable reciprocally to drive the first ratchet means (178) in a first angular direction such that the first ratchet means (178) drives the second ratchet means (174) along its longitudinal axis against the biassing means (182) along at least a part of its movement and subsequently drives the first ratchet means (178) and the second ratchet means (174) together in a second angular direction thereby to drive the piston means (180).

Description

DRIVE MECHANISM FOR AN INJECTION DEVICE
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.
In particular when considering the design of a drive system for a pen-type injector, there are a number of, sometimes, conflicting technical requirements. The drive system must be accurate and reliable, and at the same time compact and efficient. The drive system must be reliable and robust; being able to function for the life of the product. The drive system must also be intrinsically fail-safe. 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 4 shows a schematic view of an alternative drive mechanism for use with an injector in accordance with the invention.
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 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 hdusing, 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.
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. An alternative cartridge access means is disclosed in relation to Figures 16 to 23.
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 whibh 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.
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.
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.
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 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. 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 dispense 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 dispense 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.
In Figure 4, there is shown a drive mechanism in the form of a rotary solenoid 170 having an output shaft 172. The rotary solenoid typically converts linear push/pull notion to a few degrees (approx. 15°) of rotary motion by way of a spiral ball race within the solenoid. The output shaft 172 engages a first ratchet member 178. The first ratchet member 178 drives a second ratchet member 174 attached to a shaft 180 of a lead screw. The lead screw will be understood to comprise piston means for the advancement of bung 48 within a medicament cartridge 40 within the context of this description. The first and second ratchet members 178,174 are located in a housing 176. The second ratchet member 174 is biassed towards the first ratchet member 178 (here, by a helical spring 182). On a first stroke of the solenoid, the first ratchet member 178 is caused to rotate. As seen in Figure 4 the nearmost teeth of the first ratchet member 178 move upwards, thereby pushing the corresponding teeth of the second ratchet member 174 away and against the biassing means. The teeth are disposed angularly about the first and second ratchet members 178,174 to correspond to just less than the angular displacement of the output shaft of the rotary solenoid 170. At the end of the stroke the teeth of the first ratchet member 178 will have indexed to engage the next set of teeth of the second ratchet member 174. On the return stroke of the solenoid 170, the first ratchet member 178 travels in an opposite direction, thereby driving the second ratchet member 174 and the associated shaft 180 of the lead screw.

Claims

1 A drive mechanism for an injection device in which piston means are selectively driven to expel medicament from within a medicament cartridge, the drive mechanism comprising a drive means 170 associated with a first ratchet means 178, a second ratchet means 174 associated with the piston means 180, a housing 176, the first ratchet means 178 and the second ratchet means 174 being disposed within the housing 176, the second ratchet means 174 being biassed by biassing means 182 towards the first ratchet means 178, in which the drive means 170 is actuable reciprocally to drive the first ratchet means 178 in a first angular direction such that the first ratchet means 178 drives the second ratchet means 174 along its longitudinal axis against the biassing means 182 along at least a part of its movement and subsequently to drive the first ratchet means 178 and the second ratchet means 174 together in a second angular direction thereby to drive the piston means 180.
2 A drive mechanism according to claim 1, characterised in that the drive means 170 comprises a rotary solenoid.
3 A drive mechanism according to claim 1 or claim 2, characterised in that the piston means 180 comprises a lead screw.
PCT/GB2001/005705 2000-12-22 2001-12-21 Drive mechanism for an injection device WO2002051472A1 (en)

Priority Applications (13)

Application Number Priority Date Filing Date Title
KR1020037008255A KR100788316B1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
JP2002552613A JP4308524B2 (en) 2000-12-22 2001-12-21 Drive mechanism for injection device
AU2002216231A AU2002216231B2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
BRPI0116296-9A BR0116296B1 (en) 2000-12-22 2001-12-21 drive mechanism for an injection device.
CA002430920A CA2430920C (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
MXPA03005575A MXPA03005575A (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device.
DE60123836T DE60123836T2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
US10/433,782 US7699815B2 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
IL15624001A IL156240A0 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
EP01272093A EP1353712B1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
DK01272093T DK1353712T3 (en) 2000-12-22 2001-12-21 Injection device drive mechanism
IL156240A IL156240A (en) 2000-12-22 2003-06-01 Drive mechanism for an injection device
HK04102831A HK1059904A1 (en) 2000-12-22 2004-04-22 Drive mechanism for an injection device

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

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WO2002051472A1 true WO2002051472A1 (en) 2002-07-04

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Family Applications (13)

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

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PCT/GB2001/005707 WO2002051476A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005726 WO2002051481A1 (en) 2000-12-22 2001-12-21 Pen-type injector having holding mechanism for medicament cartridge
PCT/GB2001/005704 WO2002051471A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005711 WO2002051479A1 (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/GB2001/005693 WO2002058766A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit
PCT/GB2001/005710 WO2002051478A1 (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/GB2001/005721 WO2002051473A1 (en) 2000-12-22 2001-12-21 Dosing means for an injection device
PCT/GB2001/005712 WO2002051480A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit

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PCT/GB2001/005741 WO2002051474A1 (en) 2000-12-22 2001-12-21 Drive mechanism for an injection device
PCT/GB2001/005709 WO2002051477A1 (en) 2000-12-22 2001-12-21 Pen-type injector having an electronic control unit

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US (13) US6969370B2 (en)
EP (13) EP1351728B1 (en)
JP (16) JP4287148B2 (en)
KR (13) KR20030066729A (en)
CN (13) CN1482933A (en)
AT (12) ATE356644T1 (en)
AU (12) AU2002216236B2 (en)
BR (13) BR0116298B1 (en)
CA (13) CA2430931C (en)
DE (12) DE60110463T2 (en)
DK (12) DK1353715T3 (en)
ES (12) ES2247008T5 (en)
GB (1) GB0031466D0 (en)
HK (12) HK1059582A1 (en)
IL (22) IL156245A0 (en)
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DK1353715T3 (en) 2005-08-22
BR0116295A (en) 2004-08-17
WO2002051475A1 (en) 2002-07-04
ES2283375T3 (en) 2007-11-01
HK1059585A1 (en) 2004-07-09
IL156270A (en) 2009-02-11
HK1059584A1 (en) 2004-07-09
CA2430922A1 (en) 2002-07-04
KR20030066725A (en) 2003-08-09
CN1270786C (en) 2006-08-23
WO2002058767A1 (en) 2002-08-01
CN1292809C (en) 2007-01-03
HK1059902A1 (en) 2004-07-23
CA2430920C (en) 2009-04-07
CA2430931C (en) 2010-02-02
US6942646B2 (en) 2005-09-13
ATE300324T1 (en) 2005-08-15
CA2430917A1 (en) 2002-07-04
CN1481262A (en) 2004-03-10
US20040054319A1 (en) 2004-03-18
ES2246289T3 (en) 2006-02-16
WO2002051477A1 (en) 2002-07-04
EP1349591B2 (en) 2016-03-09
CA2430942C (en) 2010-02-02
BR0116276A (en) 2003-12-30
US20040078001A1 (en) 2004-04-22
JP2004523282A (en) 2004-08-05
CA2430935A1 (en) 2002-07-04
US20040054329A1 (en) 2004-03-18
US7699815B2 (en) 2010-04-20
ATE294603T1 (en) 2005-05-15
AU2002216230B2 (en) 2005-08-04
GB0031466D0 (en) 2001-02-07
DE60110929D1 (en) 2005-06-23
CN1482928A (en) 2004-03-17
DE60112326T2 (en) 2006-04-20
AU2002216256B2 (en) 2005-08-04
BR0116297B1 (en) 2010-10-19
MXPA03005578A (en) 2004-05-17
EP1349588A1 (en) 2003-10-08
JP5054739B2 (en) 2012-10-24
DE60110642D1 (en) 2005-06-09
US20040024364A1 (en) 2004-02-05
EP1349591B8 (en) 2005-12-28
BR0116280B1 (en) 2009-12-01
JP2011062538A (en) 2011-03-31
MXPA03005594A (en) 2004-05-17
JP2004516111A (en) 2004-06-03
US20040049156A1 (en) 2004-03-11
AU2002216235B2 (en) 2007-05-24
DE60110637T2 (en) 2006-01-19
CN1482929A (en) 2004-03-17
ATE342076T1 (en) 2006-11-15
US8926553B2 (en) 2015-01-06
PT1353713E (en) 2006-08-31
AU2002216254B2 (en) 2007-01-25
IL156251A (en) 2009-02-11
CN1568205A (en) 2005-01-19
EP1349595A1 (en) 2003-10-08
JP2004521681A (en) 2004-07-22
BR0116278A (en) 2003-12-30
US20040122355A1 (en) 2004-06-24
DE60110463D1 (en) 2005-06-02
MXPA03005590A (en) 2004-05-14
ATE294601T1 (en) 2005-05-15
US20040097873A1 (en) 2004-05-20
DE60110636D1 (en) 2005-06-09
CN1482927A (en) 2004-03-17
EP1353715A1 (en) 2003-10-22
CA2430940C (en) 2009-11-24
ATE295749T1 (en) 2005-06-15
BR0116273A (en) 2003-12-30
ATE294599T1 (en) 2005-05-15
IL156238A (en) 2009-02-11
DE60112472T3 (en) 2016-08-11
IL156245A (en) 2007-12-03
KR100826220B1 (en) 2008-04-30
KR100788317B1 (en) 2007-12-27
BR0116277A (en) 2003-12-30
DE60112472T2 (en) 2006-08-17
BR0116296B1 (en) 2009-12-01
ES2240341T3 (en) 2005-10-16
BR0116278B1 (en) 2010-09-21
CN1290589C (en) 2006-12-20
PT1353715E (en) 2005-08-31
DE60110463T2 (en) 2006-02-23
KR20030066739A (en) 2003-08-09
EP1353715B1 (en) 2005-05-04

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