WO2006116997A1 - Handheld injection device with integrated force sensor - Google Patents

Handheld injection device with integrated force sensor Download PDF

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Publication number
WO2006116997A1
WO2006116997A1 PCT/DK2006/000218 DK2006000218W WO2006116997A1 WO 2006116997 A1 WO2006116997 A1 WO 2006116997A1 DK 2006000218 W DK2006000218 W DK 2006000218W WO 2006116997 A1 WO2006116997 A1 WO 2006116997A1
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WO
WIPO (PCT)
Prior art keywords
injection device
force
cartridge
force sensors
handheld
Prior art date
Application number
PCT/DK2006/000218
Other languages
French (fr)
Inventor
John Thrane Hansen
Michael Svendsmark Hansen
Original Assignee
Novo Nordisk A/S
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2006116997A1 publication Critical patent/WO2006116997A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/16831—Monitoring, detecting, signalling or eliminating infusion flow anomalies
    • A61M5/16854—Monitoring, detecting, signalling or eliminating infusion flow anomalies by monitoring line pressure
    • A61M5/16859—Evaluation of pressure response, e.g. to an applied pulse
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow

Definitions

  • the present invention relates to a handheld injection device with an integrated force sensor for measuring the force provided to a plunger of a cartridge containing the medicament to be injected from the injection device.
  • US 6,368,314 relates to a process for monitoring the pressure of a liquid medicament to be administered in dosed amounts during an infusion or injection.
  • the liquid medicament is dispensable from a reservoir. Injection or infusion is provided by advancement of a piston received in the reservoir.
  • the reaction force exerted by the piston onto the housing, which serves as a measure for the fluid pressure, is hereby measured and fed to a control unit.
  • the control unit compares the measured reaction force with a predetermined reference force and controls the drive of a motor under consideration of the result of the comparison.
  • the reference force is a nominal value for the reaction force and a direct nominal/actual comparison is carried out between the measured reaction force and its nominal value.
  • US 6,368,314 further relates to a pump arrangement which is especially suited for carrying out the process.
  • US 6,659,980 relates to an infusion pump for delivering fluid to a user.
  • the infusion pump includes a housing, a motor, a reservoir, one or more drive train components, a force sensor, and an electronics system.
  • the motor is contained within the housing.
  • the reservoir contains the fluid to be delivered.
  • the one or more drive train components react to stimulus from the motor to force the fluid from the reservoir into the user.
  • the sensor is positioned to measure a parameter associated with the motor or a drive train component, and the sensor produces three or more output levels across a range of measurements.
  • the electronics system processes the sensor output levels to declare when an occlusion exists.
  • Both US 6,368,314 and US 6,659,980 relate to a pump where the medicament to be delivered is provided to a needle via catheter.
  • both US 6,368,314 and US 6,659,980 are directed to pumps capable of dispensing medicament from a reservoir in the pump and to a infusion needle via a catheter while the relevant forces are monitored by force sensors.
  • US 5,808,203 discloses a pressure measuring device comprising a pressure sensor arranged to detect the force acting on at least a portion of a contact surface of a syringe plunger during pressurization of a fluid medium within the syringe.
  • GB 2 356 349 relates to a syringe actuator assembly comprising drive means and sensor means, the drive means being capable of controlled a translational movement so as to drive a syringe plunger into a syringe body.
  • the sensor means is positioned in the force path between the drive means and the syringe plunger so as to provide an indication of the force applied by the drive means to the syringe plunger.
  • sensor means Since the sensor means is located in the force path between the drive means and the syringe plunger, an accurate indication of the force applied by a carriage to the plunger is provided. Should the pressure sensed by sensor means exceed a predetermined value suitable control means is arranged to halt the drive means and activate an alarm.
  • 5,808,203 and GB 2 356 349 both relate to determination of action forces in syringes, i.e. not to injection devices with replaceable cartridges.
  • a handheld motor operated injection device for injecting a set dose of medicament
  • the injection device comprising a motor for driving a pistol rod in order to inject the set dose of medicament from a cartridge containing the medicament, the injection device further comprising means for determining a reaction force generated in response to the motor driving the piston rod, the washer and a plunger in a forward axial direction.
  • the injection device may be a handheld injection device of the kind also including an infusion needle to be inserted directly into the patient.
  • Such motor operated injection device typically comprises an electrical motor operatively connected to some sort of gear arrangement.
  • the gear arrangement drives the piston rod which has a threaded outer surface. At least one end the piston rod may be operatively connected to a washer which is adapted to push the plunger of the cartridge in the direction, i.e. the forward axial direction, of the infusion needle.
  • the force determining means may comprise one or more force sensors positioned between a cartridge holder and a housing the injection device.
  • the determining means may comprise one or more force sensors forming an integral part or integral parts of a cartridge holder.
  • the one or more force sensors may form an integral part of for example a wall of the cartridge holder.
  • the determining means may comprise one or more force sensors being positioned between the cartridge and a cartridge holder.
  • the one or more force sensors may in principle be any kind of force sensors comprising a force sensitive element or member.
  • Such force sensitive elements or members may be constituted by one or more strain gauges or by one or more piezoelectric- or piezoresistive elements.
  • the force determining means may comprise electronic control means for processing signals generated by the one or more force sensors.
  • the electronic control means may further comprise means for generating an alarm signal if a signal from a force sensor exceeds a predetermined value.
  • Such alarm signal may be a visible or an audible alarm signal informing the user of the injection device that something is not working properly.
  • the present invention relates to a method for determining a force applied to inject a set dose of medicament in a handheld motor operated injection device, the method comprising the steps of
  • the method may further comprise the step of generating an alarm signal when the measured reaction force exceeds a predetermined value so that the risk of damages to the injection device can be significantly reduced.
  • reaction force applied to a part or parts of the injection device one or more force sensors positioned between a cartridge holder and a housing of the injection device, or between the cartridge and a cartridge holder, may be used.
  • the reaction force may be measured using one or more force sensors forming an integral part or parts of a cartridge holder, such as for example a sidewall portion of the cartridge holder.
  • the one or more force sensors may in principle be any kind of force sensors comprising a force sensitive element or member.
  • Such force sensitive elements or members may be constituted by one or more strain gauges or by one or more piezoelectric- or piezoresistive elements.
  • Fig. 1 shows various possible positions of a force sensor for measuring the action force provided to the plunger.
  • Fig. 1 illustrates various possible positions of a force sensor being capable of measuring the force provided by the motor in a motor operated injection device.
  • Fig. 1 shows the relevant components of such a motor operated injection device.
  • the injection device comprises, among other components, a motor 1, such as an electrical motor, positioned in a housing 2.
  • a drive mechanism 8 is operatively connected to the motor 1 via some sort of gear arrangement 9.
  • the drive mechanism 8 drives the piston rod 10 in a forward direction towards the cartridge 5 containing the medicament, such as insulin, to be injected from the injection device.
  • the cartridge 5, which is positioned in a cartridge holder 6, comprises a plunger 4 which keeps the medicament in the cartridge 6.
  • the plunger 4 is movable along a longitudinal axis of the cartridge 5 whereby the medicament contained in the cartridge 5 can be injected from the cartridge 5 by moving the plunger towards the needle-end of the cartridge 5.
  • an infusion needle 7 is mounted.
  • the medicament contained in the cartridge 5 is injected from the injection device by rotating the motor 1 a predetermined angular distance. This angular distance corresponds to a set dose of medicament to be injected from the injection device.
  • the drive mechanism 8 causes the piston rod 10 to perform an axial movement in a direction towards the cartridge 5.
  • the piston rod 10 has a treaded outer surface typically arranged in the entire length of the piston rod 10. The threaded outer surface may also be arranged in just part of the entire length of the piston rod 10. This threaded outer surface engages with a corresponding threaded inner surface of the drive mechanism 8. This engagement between the piston rod 10 and the drive mechanism 8 causes the piston rod 10 to perform an axial movement towards the cartridge 5 when the motor 1 is rotating.
  • a washer 3 is attached to the piston rod 10.
  • the washer 3 abuts the plunger 4 so that a forward movement of the piston rod 10 causes the washer 3 to move the plunger 4 towards the needle-end of the cartridge 5.
  • a force sensor for measuring the force applied by the motor can be positioned in various positions. In Fig. 1 these positions are denoted A, B, and C. In positions A force sensors are positioned between the housing of the injection device and the cartridge holder. When a force is applied to the plunger via the piston rod and washer the cartridge pushes the cartridge holder in the direction of the needle. If the cartridge holder is suspended in force sensitive elements relative to the housing of the injection device, the applied force can be measured by positioning one or more force sensors between the cartridge holder and the housing of the injection device.
  • a force sensor suitable for being integrated with or built into an injection device can be implemented in various manners.
  • a sensor may rely on one or more strain gauges or it may rely on one or more piezo elements, such as piezoelectric or piezoresistive elements.
  • the resistance of the active component(s) changes when the active component is exposed to stress.
  • a piezoelectric element a voltage change is generated across the piezoelectric element when the piezoelectric element is exposed to stress.
  • one or more force sensors can be integrated into the cartridge holder, such as integrated into the side walls of the cartridge holder. Such integration could be implemented by incorporating a set of strain gauges into the side walls of the cartridge holder. When a force is applied to the plunger via the piston rod and the washer the cartridge holder is stretched. This stretching of the cartridge holder can be measured by one or more strain gauges or by one or more piezo elements integrated into the cartridge holder.
  • one or more force sensors can be positioned between the cartridge and the cartridge holder.
  • the force sensor When the force sensor (or force sensors) is positioned as illustrated in connection with embodiments A and C the force sensor is exposed to a force that compresses the sensor. When the force sensor (or force sensors) is integrated into the side walls of the cartridge holder the force sensor is stretched in that the upper and lower parts of the cartridge holder are pulled apart.
  • the injection device By having a force sensor incorporated in the injection device it becomes possible to detect when the entire dosage has been injected. This can be applied to assist the user of the injection device to remove the needle from the skin only when the injection has been completed. With a force sensor the injection device can register when the full dosage has been delivered since the force measured by the force sensor returns to approximately zero when the injection has been completed.
  • the injection device comprises a force sensor this situation can be avoided because the force sensor is capable of measuring whether or not contact between the washer and plunger has been established before an injection is initiated. This feature is of especially importance when a cartridge has been replaced and physical contact between the washer and the plunger is to be established before the first injection.
  • malfunctioning due to for example a blocked needle can also be detected by incorporating a pressure sensor in the injection device.
  • the injection device will further comprise an electronic control module for processing signals generated by the one or more force sensors.
  • the electronic control module is adapted to generate a visible or audible alarm signal if a signal from a force sensor so demands.
  • An alarm can for example be generated if a signal from a force sensor exceeds a predetermined value.

Abstract

The present invention relates to a handheld motor operated injection device comprising a motor for driving a pistol rod operatively connected to a washer in order to inject the set dose of medicament from a cartridge containing the medicament. The injection device further comprises means for determining a reaction force generated in response to the motor driving the piston rod, the washer and a plunger in a forward axial direction in the cartridge.

Description

HANDHELD INJECTION DEVICE WITH INTEGRATED FORCE SENSOR
The present invention relates to a handheld injection device with an integrated force sensor for measuring the force provided to a plunger of a cartridge containing the medicament to be injected from the injection device.
BACKGROUND OF THE INVENTION
US 6,368,314 relates to a process for monitoring the pressure of a liquid medicament to be administered in dosed amounts during an infusion or injection. The liquid medicament is dispensable from a reservoir. Injection or infusion is provided by advancement of a piston received in the reservoir. The reaction force exerted by the piston onto the housing, which serves as a measure for the fluid pressure, is hereby measured and fed to a control unit. The control unit compares the measured reaction force with a predetermined reference force and controls the drive of a motor under consideration of the result of the comparison. The reference force is a nominal value for the reaction force and a direct nominal/actual comparison is carried out between the measured reaction force and its nominal value. US 6,368,314 further relates to a pump arrangement which is especially suited for carrying out the process.
US 6,659,980 relates to an infusion pump for delivering fluid to a user. The infusion pump includes a housing, a motor, a reservoir, one or more drive train components, a force sensor, and an electronics system. The motor is contained within the housing. The reservoir contains the fluid to be delivered. The one or more drive train components react to stimulus from the motor to force the fluid from the reservoir into the user. The sensor is positioned to measure a parameter associated with the motor or a drive train component, and the sensor produces three or more output levels across a range of measurements. The electronics system processes the sensor output levels to declare when an occlusion exists.
Both US 6,368,314 and US 6,659,980 relate to a pump where the medicament to be delivered is provided to a needle via catheter. Thus, both US 6,368,314 and US 6,659,980 are directed to pumps capable of dispensing medicament from a reservoir in the pump and to a infusion needle via a catheter while the relevant forces are monitored by force sensors.
US 5,808,203 discloses a pressure measuring device comprising a pressure sensor arranged to detect the force acting on at least a portion of a contact surface of a syringe plunger during pressurization of a fluid medium within the syringe. GB 2 356 349 relates to a syringe actuator assembly comprising drive means and sensor means, the drive means being capable of controlled a translational movement so as to drive a syringe plunger into a syringe body. The sensor means is positioned in the force path between the drive means and the syringe plunger so as to provide an indication of the force applied by the drive means to the syringe plunger. Since the sensor means is located in the force path between the drive means and the syringe plunger, an accurate indication of the force applied by a carriage to the plunger is provided. Should the pressure sensed by sensor means exceed a predetermined value suitable control means is arranged to halt the drive means and activate an alarm.
Neither of US 5,808,203 and GB 2 356 349 disclose a handheld device. In addition, US
5,808,203 and GB 2 356 349 both relate to determination of action forces in syringes, i.e. not to injection devices with replaceable cartridges.
It is an object of the present invention to provide a handheld, motor operated injection device wherein the force provided by the motor can be accurately determined by measuring a generated reaction force.
It is a further object of the present invention to provide a handheld, motor operated injection device wherein the action force provided to a cartridge containing a medicament to be injected from the injection device can be determined more accurately by measuring a generated reaction force so that damages due to malfunctioning of the injection device can be avoided. Such malfunctioning can for example be caused by a blocked needle.
SUMMARY OF THE INVENTION
The above-mentioned object is complied with by providing, in a first aspect, a handheld motor operated injection device for injecting a set dose of medicament, the injection device comprising a motor for driving a pistol rod in order to inject the set dose of medicament from a cartridge containing the medicament, the injection device further comprising means for determining a reaction force generated in response to the motor driving the piston rod, the washer and a plunger in a forward axial direction.
The injection device may be a handheld injection device of the kind also including an infusion needle to be inserted directly into the patient. Such motor operated injection device typically comprises an electrical motor operatively connected to some sort of gear arrangement. The gear arrangement drives the piston rod which has a threaded outer surface. At least one end the piston rod may be operatively connected to a washer which is adapted to push the plunger of the cartridge in the direction, i.e. the forward axial direction, of the infusion needle.
The force determining means may comprise one or more force sensors positioned between a cartridge holder and a housing the injection device. In an alternative embodiment, the determining means may comprise one or more force sensors forming an integral part or integral parts of a cartridge holder. Thus, the one or more force sensors may form an integral part of for example a wall of the cartridge holder. Finally, the determining means may comprise one or more force sensors being positioned between the cartridge and a cartridge holder.
The one or more force sensors may in principle be any kind of force sensors comprising a force sensitive element or member. Such force sensitive elements or members may be constituted by one or more strain gauges or by one or more piezoelectric- or piezoresistive elements.
The force determining means may comprise electronic control means for processing signals generated by the one or more force sensors. The electronic control means may further comprise means for generating an alarm signal if a signal from a force sensor exceeds a predetermined value. Such alarm signal may be a visible or an audible alarm signal informing the user of the injection device that something is not working properly.
In a second aspect, the present invention relates to a method for determining a force applied to inject a set dose of medicament in a handheld motor operated injection device, the method comprising the steps of
- operating an electrical motor of the handheld injection device so as to drive a piston rod in an axial and forward direction in a cartridge containing the medicament to be injected, and
- measuring a reaction force acting on a part or parts of the injection device.
The method may further comprise the step of generating an alarm signal when the measured reaction force exceeds a predetermined value so that the risk of damages to the injection device can be significantly reduced.
To measure the reaction force applied to a part or parts of the injection device one or more force sensors positioned between a cartridge holder and a housing of the injection device, or between the cartridge and a cartridge holder, may be used. Finally, the reaction force may be measured using one or more force sensors forming an integral part or parts of a cartridge holder, such as for example a sidewall portion of the cartridge holder.
Again, the one or more force sensors may in principle be any kind of force sensors comprising a force sensitive element or member. Such force sensitive elements or members may be constituted by one or more strain gauges or by one or more piezoelectric- or piezoresistive elements.
BRIEF DESCRIPTION OF THE DRAWING
The present invention will now be explained in further details with reference to the accompanying Fig. 1 which shows various possible positions of a force sensor for measuring the action force provided to the plunger.
While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION OF THE INVENTION
Fig. 1 illustrates various possible positions of a force sensor being capable of measuring the force provided by the motor in a motor operated injection device. Fig. 1 shows the relevant components of such a motor operated injection device.
As seen in Fig. 1, the injection device comprises, among other components, a motor 1, such as an electrical motor, positioned in a housing 2. A drive mechanism 8 is operatively connected to the motor 1 via some sort of gear arrangement 9. The drive mechanism 8 drives the piston rod 10 in a forward direction towards the cartridge 5 containing the medicament, such as insulin, to be injected from the injection device. The cartridge 5, which is positioned in a cartridge holder 6, comprises a plunger 4 which keeps the medicament in the cartridge 6. The plunger 4 is movable along a longitudinal axis of the cartridge 5 whereby the medicament contained in the cartridge 5 can be injected from the cartridge 5 by moving the plunger towards the needle-end of the cartridge 5. At this needle-end an infusion needle 7 is mounted. The medicament contained in the cartridge 5 is injected from the injection device by rotating the motor 1 a predetermined angular distance. This angular distance corresponds to a set dose of medicament to be injected from the injection device. Upon rotation of the motor 1 the drive mechanism 8 causes the piston rod 10 to perform an axial movement in a direction towards the cartridge 5. The piston rod 10 has a treaded outer surface typically arranged in the entire length of the piston rod 10. The threaded outer surface may also be arranged in just part of the entire length of the piston rod 10. This threaded outer surface engages with a corresponding threaded inner surface of the drive mechanism 8. This engagement between the piston rod 10 and the drive mechanism 8 causes the piston rod 10 to perform an axial movement towards the cartridge 5 when the motor 1 is rotating.
A washer 3 is attached to the piston rod 10. The washer 3 abuts the plunger 4 so that a forward movement of the piston rod 10 causes the washer 3 to move the plunger 4 towards the needle-end of the cartridge 5.
As illustrated in Fig. 1 a force sensor for measuring the force applied by the motor can be positioned in various positions. In Fig. 1 these positions are denoted A, B, and C. In positions A force sensors are positioned between the housing of the injection device and the cartridge holder. When a force is applied to the plunger via the piston rod and washer the cartridge pushes the cartridge holder in the direction of the needle. If the cartridge holder is suspended in force sensitive elements relative to the housing of the injection device, the applied force can be measured by positioning one or more force sensors between the cartridge holder and the housing of the injection device.
A force sensor suitable for being integrated with or built into an injection device can be implemented in various manners. For example such a sensor may rely on one or more strain gauges or it may rely on one or more piezo elements, such as piezoelectric or piezoresistive elements. In case of a strain gauge- or piezoresistive-based sensor the resistance of the active component(s) changes when the active component is exposed to stress. In case of a piezoelectric element a voltage change is generated across the piezoelectric element when the piezoelectric element is exposed to stress.
In an alternative embodiment, illustrated as embodiment B in Fig. 1, one or more force sensors can be integrated into the cartridge holder, such as integrated into the side walls of the cartridge holder. Such integration could be implemented by incorporating a set of strain gauges into the side walls of the cartridge holder. When a force is applied to the plunger via the piston rod and the washer the cartridge holder is stretched. This stretching of the cartridge holder can be measured by one or more strain gauges or by one or more piezo elements integrated into the cartridge holder. In another embodiment, illustrated as embodiment C in Fig. 1, one or more force sensors can be positioned between the cartridge and the cartridge holder. When a force is provided to the plunger via the piston rod and the washer the cartridge containing the medicament to be injected from the injection device is pushed against the bottom part of the cartridge holder. By having the force sensor positioned between the cartridge and the cartridge holder the action force provided to the plunger is can be measured.
When the force sensor (or force sensors) is positioned as illustrated in connection with embodiments A and C the force sensor is exposed to a force that compresses the sensor. When the force sensor (or force sensors) is integrated into the side walls of the cartridge holder the force sensor is stretched in that the upper and lower parts of the cartridge holder are pulled apart.
By having a force sensor incorporated in the injection device it becomes possible to detect when the entire dosage has been injected. This can be applied to assist the user of the injection device to remove the needle from the skin only when the injection has been completed. With a force sensor the injection device can register when the full dosage has been delivered since the force measured by the force sensor returns to approximately zero when the injection has been completed.
Furthermore, if the user of the injection device forgets to prime - i.e. move the piston rod forward so that the washer abuts the plunger prior to initiating an injection - there is a significant risk of injecting a dosage that is lower than the intended dosage. The reason for this being that contact between the washer and the plunger may not have been established prior to initiating the injection. If the injection device comprises a force sensor this situation can be avoided because the force sensor is capable of measuring whether or not contact between the washer and plunger has been established before an injection is initiated. This feature is of especially importance when a cartridge has been replaced and physical contact between the washer and the plunger is to be established before the first injection.
Finally, malfunctioning due to for example a blocked needle can also be detected by incorporating a pressure sensor in the injection device.
The injection device will further comprise an electronic control module for processing signals generated by the one or more force sensors. The electronic control module is adapted to generate a visible or audible alarm signal if a signal from a force sensor so demands. An alarm can for example be generated if a signal from a force sensor exceeds a predetermined value.

Claims

1. A handheld motor operated injection device for injecting a set dose of medicament, the injection device comprising a motor (1) for driving a pistol rod (10) operatively connected to a washer (3) in order to inject the set dose of medicament from a cartridge (5) containing the medicament, the injection device further comprising means for determining a reaction force generated in response to the motor (1) driving the piston rod (10), the washer (3) and a plunger (4) in a forward axial direction.
2. A handheld injection device according to claim 1, wherein the determining means comprises one or more force sensors arranged between a cartridge holder (6) and a housing (2) of the injection device.
3. A handheld injection device according to claim 1, wherein the determining means comprises one or more force sensors arranged between the cartridge (5) and a cartridge holder (6).
4. A handheld injection device according to claim 1, wherein the determining means comprises one or more force sensors forming an integral part or parts of a cartridge holder (6).
5. A handheld injection device according to any of claims 2-4, wherein the one or more force sensors comprise one or more strain gauges.
6. A handheld injection device according to any of claims 2-4, wherein the one or more force sensors comprise one or more piezoelectric elements.
7. A handheld injection device according to any of claims 2-6, wherein the force determining means comprises electronic control means for processing signals generated by the one or more force sensors, the electronic control means further comprising means for generating an alarm signal if a signal from a force sensor exceeds a predetermined value.
8. A method for determining a force applied to inject a set dose of medicament in a handheld injection device, the method comprising the steps of
- operating an electrical motor of the handheld injection device so as to drive a piston rod in an axial and forward direction in a cartridge containing the medicament to be injected, and - measuring a reaction force acting a part or parts of the injection device.
9. A method according to claim 8, further comprising the step of generating an alarm signal when the measured reaction force exceeds a predetermined value.
10. A method according to claim 8 or 9, wherein the reaction force is measured using one ore more force sensors arranged between a cartridge holder and a housing of the injection device.
11. A method according to claim 8 or 9, wherein the reaction force is measured using one or more force sensors arranged between the cartridge and a cartridge holder.
12. A method according to claim 8 or 9, wherein the reaction force is measured using one or more force sensors forming an integral part or parts of a cartridge holder.
13. A method according to any of claims 10-12, wherein the one or more force sensors comprise one or more strain gauges.
14. A method according to any of claims 10-12, wherein the one or more force sensors comprise one or more piezoelectric elements.
PCT/DK2006/000218 2005-04-29 2006-04-25 Handheld injection device with integrated force sensor WO2006116997A1 (en)

Applications Claiming Priority (2)

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EP05009462.2 2005-04-29
EP05009462 2005-04-29

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US7682338B2 (en) 2006-08-23 2010-03-23 Medtronic Minimed, Inc. Infusion medium delivery system, device and method with needle inserter and needle inserter device and method
US7686787B2 (en) 2005-05-06 2010-03-30 Medtronic Minimed, Inc. Infusion device and method with disposable portion
US7736344B2 (en) 2006-08-23 2010-06-15 Medtronic Minimed, Inc. Infusion medium delivery device and method with drive device for driving plunger in reservoir
US7794434B2 (en) 2006-08-23 2010-09-14 Medtronic Minimed, Inc. Systems and methods allowing for reservoir filling and infusion medium delivery
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US7828764B2 (en) 2006-08-23 2010-11-09 Medtronic Minimed, Inc. Systems and methods allowing for reservoir filling and infusion medium delivery
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