WO2002064196A1 - Electronically controlled injection or infusion device - Google Patents
Electronically controlled injection or infusion device Download PDFInfo
- Publication number
- WO2002064196A1 WO2002064196A1 PCT/DK2002/000098 DK0200098W WO02064196A1 WO 2002064196 A1 WO2002064196 A1 WO 2002064196A1 DK 0200098 W DK0200098 W DK 0200098W WO 02064196 A1 WO02064196 A1 WO 02064196A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- signal
- sealed
- input
- circuit block
- circuit
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—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
- A61M5/31548—Mechanically operated dose setting member
- A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
- A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
-
- 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
-
- 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
- A61M2005/3125—Details specific display means, e.g. to indicate dose setting
-
- 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
- A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
-
- 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
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
- A61M2205/52—General characteristics of the apparatus with microprocessors or computers with memories providing a history of measured variating parameters of apparatus or patient
-
- 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
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/31573—Accuracy improving means
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01D—MEASURING NOT SPECIALLY ADAPTED FOR A SPECIFIC VARIABLE; ARRANGEMENTS FOR MEASURING TWO OR MORE VARIABLES NOT COVERED IN A SINGLE OTHER SUBCLASS; TARIFF METERING APPARATUS; MEASURING OR TESTING NOT OTHERWISE PROVIDED FOR
- G01D5/00—Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable
- G01D5/12—Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using electric or magnetic means
- G01D5/244—Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using electric or magnetic means influencing characteristics of pulses or pulse trains; generating pulses or pulse trains
- G01D5/245—Mechanical means for transferring the output of a sensing member; Means for converting the output of a sensing member to another variable where the form or nature of the sensing member does not constrain the means for converting; Transducers not specially adapted for a specific variable using electric or magnetic means influencing characteristics of pulses or pulse trains; generating pulses or pulse trains using a variable number of pulses in a train
- G01D5/2451—Incremental encoders
Definitions
- the invention relates to electrically controlled devices for injecting or infusing medical prepa- rations in the human body.
- administration devices For patients suffering from diseases, which provoke the need for frequent administration of liquid medicine which is injected or infused into the patient, administration devices has been developed in the form of syringes by which a dose of medicine can easily be set and successive- sively injected by the patient himself. Also pumps have been developed which pumps continuously or semi continuously, i. e. in repetitive small doses, infuse a small flow of the medicine through a catheter into the body of the patient.
- the pumps have to be equipped with a power supply which can drive the pump.
- the power supply is mainly an electric battery supplying an electric motor driving a piston into a cartridge to successively press out the content thereof through the catheter.
- pumps may be differently designed as membrane pumps or as another kind of cyclic working pumps, but common to most pumps is, that they are electric powered from an electric battery and controlled by an electric circuit, which is programmed to power the pump in a way ensuring the administration of the correct flow of medicine.
- the electric circuit can further receive information from sensors distributed in the pump to survey that the pump is working properly and the circuit can control the powering in a way which promotes the correct working.
- the sensors may be switches which occupy “off' or “on” positions reflecting the positions of mechanical parts of the device.
- pulse generators can be realised as switches, which are alternating closed and opened. Signals are sent from the sensors to an electronic circuit in which the signals are evaluated and corresponding mes- sages are sent to a display on which the condition of the device can be read.
- the electronic circuit may be a common commercial circuit or an integrated circuit block which is designed and manufactured specifically to be used in the device in question. Once such an integrated circuit block has left the production line as a functioning circuit it is very reliable, and failing of the device is mainly due to the wiring and connections to sensors out- side the circuit. Especially sensors based on mechanical contacts are rather sensible to wear, dust and oxidation.
- an electrically controlled device for injecting or infusing medical prepara- tions into the human body in which devices the controlling is performed by a sealed electric circuit block receiving signals from sensors which monitors selected parameters describing conditions of the device, which device is characterised in that the sensors are integrated in the sealed circuit block and are of a kind with no mechanically opened or closed switches.
- the sensors can be light sensors, e. g. photocells, magnetic sensors, e. g. Hall elements, or coils in which a current is induced by an outer magnetic field, load cells which gives of an electric signal when they sense a mechanical pressure. Common to all these sensors are that their electric conditions are changed without involving any wear and dirt sensible switches. Even emission of light can be obtained by the sealed electronic circuit block by es- tablishing of so-called laser wells.
- the sealed circuit block, a power supply for this circuit block, and other electronic components connected to said circuit block may be accommodated in one rigid part of the device. Thereby movable electric connections are avoided.
- the rigid part of the device may appropriately be a button which can be used for setting or injecting a dose of a medicine.
- At least one of the sensors may be a Hall element.
- a Hall element may be signalled by a movable magnet fixed to a part of the device to monitor the position of this part relative to the part accommodating the electronic circuit block.
- the sealed electronic circuit block may comprise a timer which may have a first input for a reset signal, a second input for a signal activating a read out of the timer, and an output to a display displaying the read out of the time lapsed after the latest receipt of a signal on said first input, the injection device further being provided with a sensor connected to the first input of said timer, which sensor gives off a signal when the injection button is pressed to move the piston rod, and with a means for optional sending of a signal to the second input to activate the read out of the electronic circuit.
- the electronic circuit in the sealed circuit block may be so designed that a signal sent to said second input opens the energising of the Hall element and other energy consuming sensors. This way the Hall element and other sensors may be energised only when they are going to perform a monitoring function whereas they are switched off when the device is stored. During storage power is still supplied to the timer and memory functions.
- the circuit may further be so designed that a signal is sent to said first input when a Hall element in the sealed electronic circuit block detects a change of the position of a magnet relative to the part accommodating the sealed electronic circuit block.
- the means optionally sending a signal to the second input may be a switch outside the sealed electronic circuit block.
- This switch may be a conventional switch in the power supply for the Hall element.
- the Hall element When the device is so designed that the Hall element is not activated during the setting of a dose but is activated during the injection it can count the number of units injected and may at the same time send a signal to said first input.
- the magnet may have the shape of a ring having a number of alternating poles along its perimeter
- Hall elements may be used and the magnet ring may have 12 poles.
- the Hall elements may be so distributed along an arc of a circle that, a first Hall element is positioned facing a north pole a third Hall element is facing a neighbour south pole, a second Hall element is facing the neutral zone between said north pole and said south pole, and a fourth Hall element is facing the neutral zone between said south pole and the succeeding north pole, i. e. the length of the circular arc is 45°.
- the magnet poles of the magnet ring creates a sine shaped magnet field with a full sine wave for each pair of poles.
- a phase angle of 360° for the sine curve corresponds to 60° of rotation.
- the Hall elements placed as described the phase angle at the respective positions of the Hal elements are 0°, 90°, 180°, and 270°, repectively.
- the outputs from the first and the third Hal element may be connected to input terminals on a first differential operational amplifier and the outputs from the second and the fourth Hall elements are connected to input terminals on a second differential operational amplifier, and output signals from the differential operational amplifiers are through analogue/digital converters and a normalising circuit lead to a look up table circuit wherein one signal is divided with the other to obtain a tangent function which is used as entrance to a table.
- a quadrature measurement is obtained by which one signal is a sine signal and another is a cosine signal.
- an tangent function is obtained.
- tangent value is independent of the amplitudes of the sine and the cosine signals the sensor will be insensitive to variations in the magnetic field strength and consequently independent of the air gap between the magnet ring and the sensor.
- the tangent value obtained refers to a magnetic angle which can be found in the table. Also account must be taken for the number of times a 360° magnetic cycle has been run through. On the basis hereof the rotation angle for the dose setting drum can be found when the number of poles on the ring is known.
- Figure 1 shows a detail of an injection device with an integrated circuit block according to the invention
- Figure 2 shows schematically the relative positioning of a magnet ring and a sealed circuit block containing four Hall elements.
- Figure 3 shows a block diagram of the integrated circuit transforming the readings of the Hall elements into a rotation angle of the dosing mecha- nism.
- Figure 1 shows the proximal end of an injection device comprising a combined dose setting and injection button 1 , which button is rotated to set a dose and pressed in an axial direction to inject the set dose.
- the button 1 is fixed to a tubular element 2 so that element 2 will follow as well rotational as axial movements of the button 1.
- the tubular element 2 When the button 1 is rotated to set a dose the tubular element 2 is rotated too.
- the tubular element 2 has a flange 3 carrying a number of ⁇ -shaped teeth 4 which engages corresponding depressions in an internal circumferential flange 5 in a dose setting drum 6 con- centric with the tubular element 2 so that said drum 6 is rotated with said tubular element 2 and the button 1 when said button is rotated to set a dose.
- the dose setting drum 6 When the dose setting drum 6 is rotated it will, due to a not shown thread connection between said drum 6 and a not shown housing concentrically surrounding said dose setting drum 6 and said tubular element 2, be screwed outward in said housing and will lift the button 1 up from the end of said housing.
- the button 1 accommodates an electronic unit mounted on a circuit board 15 and comprising a sealed circuit block 10, which is powered by a battery 11 through contacts 12 and 13. From the circuit block 10 output signals are fed through a multi wire cable to a LCD display 14. Further the sealed circuit block 10 has an integrated magnetic sensible component 17 which can give off a signal when it is moved relative to a magnet ring 7 at the upper end of the dose setting drum 6. The magnetic ring 7 is magnetised to have a number of alternating magnetic poles along its perimeter. When the dose-setting drum rotates relative to the button 1 the sensor 17 will give off a signal reflecting the magnetic field sensed by this sensor.
- the end wall of the button 1 is provided with a window 8 made from a transparent material to allow inspection of the display 14.
- the electronic circuit in the sealed circuit block 10 comprises a timer which is started when a dose is injected and the status of which is shown for a while in the display 14 when the button 1 is pressed by pressing the window 8 so that the electronic unit in the button 1 is moved against the force of a spring 19 whereby a button 20 of a switch 18 is pressed to acti- vate said switch.
- the switch 18 When the switch 18 is activated it may give off a signal inducing a read out of the stopwatch.
- the switch 18 can be a main switch opening for the energising of this Hall element.
- Injection is detected by the sensor 17 when the ring 7 with alternating magnetic poles is rotated relative to the button 1. During the setting of a dose such relative rotation is not performed. At the beginning of its movement the button is moved axially relative to the dose setting drum 6 until the teeth 4 on the flange 3 of the tubular element 2 are moved out of engagement with the depressions in the flange 5 of the dose setting drum 6.
- the activation of the switch 18 will provide a signal which directly or indirectly triggers the circuit block 10 to activate the display 14 for a while to show the status of the timer. As a test all segments are shortly turned on to show that they are all operative before information is shown. If a dose has been set, further pressing of the button 1 will bring the teeth 4 out of engagement with the depressions in the flange 5 on the dose setting drum 6 whereby said dose setting drum is allowed to rotate relative to the button 1 which relative rotation is de- tected by the sensor17 which generates a signal in the integrated circuit block 10 indicating that an injection is made. When the button 1 is released after an injection all the segments are shortly turned on one by one.
- injection may be detected by using a sensor sensing the movement of a piston rod, which is magnetised with alternating poles.
- the rotation to be detected may be the relative rotation between the button and a finger pad at the end of the button, which finger pad follows the button during the dose set- ting but relative to which the button is rotated during injection.
- the circuit may be so programmed that such relative movement is only taken as an indication of an injection when the button is pressed.
- the button in which the electric components are integrated although it is described as a fixed part of the device, may be removable so that it can be moved from a possible disposable injection device and mounted on a new one, only the devices must be provided with the necessary signaller to generate signals from the sensors. This may appropriately be obtained by mould- ing such signallers into the syringes by using a mouldable magnetic plastic material.
- Figure 2 schematically shows the magnet ring 7 seen from the end of the device and shows the positions of a first 21 , a second 22, a third 23, and a fourth 24 Hall element in the sealed circuit block 10 relative to the poles of the magnet ring 7.
- This position can be seen as a start position from which the button is screwed away during the setting of a dose and to which the button returns when a set dose has been injected.
- the ring 7 is magnetised to present along it perimeter a sinus shaped magnetic field oscillating 360°. between two poles having the same polarity. With twelve poles along the perimeter of the ring a 360° magnetic angle will correspond to a 60° rotation of the button 1.
- the Hall elements 21-24 works together with the magnet ring 7 to monitor the relative rotation of the button 1 relative to the drum 6 as the length of this rotation is proportional with the number of doses injected.
- this monitoring Is made by leading the output signal from the first 21 and the third 23 Hall elements to the inputs of a differential operational amplifier 25 as shown in figure 3.
- phase angle is calculated relative to the magnet poles so that a rotation which brings a Hall element from a pole with one polarity to the next pole with the same polarity is defined as a phase angle of 360° which in the shown example corresponds to a 60° rotation of the drum 6.
- the second 22 and the fourth 24 Hall element is coupled to the inputs of a differential operational amplifier 26 from which the output signal which is proportional with the sinus of phase angle is sent through an analogue/digital converter 28.
- the signals from the AD converters 27 and 28 are normalised in a circuit 29 which has two output terminals 30 and 31 which gives off signals which can address a look up table in a circuit 32 to provide at an output 33 an output signal indicating the rotation angle of the drum 6 relative to the button 1.
- the output from the table can be used for calculating the number of units which have been injected.
- the operational amplifiers 25 and 26, the A/D converters 27 and 28, the normalising circuit and the look up table can all be integrated in the sealed circuit block.
- the output signal from the table 32 can also internally in the circuit block 10 be stored in a storage from which a likewise integrated driver for the display 14 is driven to make the display shown the latest injected dose.
Abstract
Description
Claims
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02711784A EP1361908B1 (en) | 2001-02-14 | 2002-02-12 | Electronically controlled injection or infusion device |
JP2002563988A JP4278382B2 (en) | 2001-02-14 | 2002-02-12 | Electronically controlled syringe or injection device |
DE60224167T DE60224167T2 (en) | 2001-02-14 | 2002-02-12 | ELECTRONICALLY CONTROLLED INJECTION OR INFUSION DEVICE |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DKPA200100240 | 2001-02-14 | ||
DKPA200100240 | 2001-02-14 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2002064196A1 true WO2002064196A1 (en) | 2002-08-22 |
Family
ID=8160220
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/DK2002/000098 WO2002064196A1 (en) | 2001-02-14 | 2002-02-12 | Electronically controlled injection or infusion device |
Country Status (6)
Country | Link |
---|---|
US (1) | US7008399B2 (en) |
EP (3) | EP2319565A3 (en) |
JP (1) | JP4278382B2 (en) |
AT (1) | ATE381360T1 (en) |
DE (1) | DE60224167T2 (en) |
WO (1) | WO2002064196A1 (en) |
Cited By (60)
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WO2005005929A2 (en) * | 2003-07-09 | 2005-01-20 | Tecpharma Licensing Ag | Contactless scanning by means of a magnetoresistive sensor |
WO2005004956A1 (en) | 2003-07-09 | 2005-01-20 | Tecpharma Licensing Ag | Injection device comprising a position sensor |
WO2006045523A1 (en) * | 2004-10-21 | 2006-05-04 | Novo Nordisk A/S | Medication delivery system with a detector for providing a signal indicative of an amount of an ejected dose of drug |
WO2006069455A1 (en) * | 2004-12-31 | 2006-07-06 | Tecpharma Licensing Ag | Real-time display for a device for the dosed administration of a product |
WO2008015095A1 (en) * | 2006-08-04 | 2008-02-07 | Endress+Hauser Conducta Gesellschaft Für Mess- Und Regeltechnik Mbh+Co. Kg | Instrument for automation with single-handed operation |
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US8353878B2 (en) | 2007-03-23 | 2013-01-15 | Novo Nordisk A/S | Injection device comprising a locking nut |
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US10682469B2 (en) | 2017-12-04 | 2020-06-16 | Novo Nordisk A/S | Drug delivery system with magnetic ring and sensors arranged in a ring pattern |
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Also Published As
Publication number | Publication date |
---|---|
EP1361908B1 (en) | 2007-12-19 |
ATE381360T1 (en) | 2008-01-15 |
US20020143288A1 (en) | 2002-10-03 |
US7008399B2 (en) | 2006-03-07 |
EP2319565A3 (en) | 2013-07-17 |
JP2004526486A (en) | 2004-09-02 |
DE60224167T2 (en) | 2008-12-04 |
EP1808193A1 (en) | 2007-07-18 |
EP2319565A2 (en) | 2011-05-11 |
EP1361908A1 (en) | 2003-11-19 |
DE60224167D1 (en) | 2008-01-31 |
JP4278382B2 (en) | 2009-06-10 |
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