WO2013073650A1 - Dispositif d'injection pourvu d'une unité de mesure de température - Google Patents

Dispositif d'injection pourvu d'une unité de mesure de température Download PDF

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Publication number
WO2013073650A1
WO2013073650A1 PCT/JP2012/079737 JP2012079737W WO2013073650A1 WO 2013073650 A1 WO2013073650 A1 WO 2013073650A1 JP 2012079737 W JP2012079737 W JP 2012079737W WO 2013073650 A1 WO2013073650 A1 WO 2013073650A1
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WIPO (PCT)
Prior art keywords
syringe
injection device
temperature
piston rod
unit
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PCT/JP2012/079737
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English (en)
Japanese (ja)
Inventor
花田　崇
Original Assignee
日本ケミカルリサーチ株式会社
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Publication of WO2013073650A1 publication Critical patent/WO2013073650A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/581—Means for facilitating use, e.g. by people with impaired vision by audible feedback
    • 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
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31546—Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons

Definitions

  • the present invention relates to an injection device having a function of issuing a warning to a user when it is exposed to a temperature outside a preset range for a certain period of time.
  • a dry drug component by freeze-drying, etc.
  • the preparation is provided in the form of a two-drug form consisting of a drug component (dissolution solution such as a buffer).
  • a two-chamber prefilled syringe multi-chamber in which these components are separately stored in a single syringe (syringe) Cylinder ampules are also widely used (Patent Documents 1 to 3).
  • This type of preparation is used in such a manner that before use, a dry drug component and a drug component are mixed to form a solution preparation containing a peptide, which is then administered to a patient. Since peptides in solution are highly sensitive to temperature changes, they are generally stored at 2-8 ° C., avoiding freezing.
  • Solution preparations containing peptides include ones in which a drug solution for a plurality of doses is stored in a syringe and used in a dedicated injection device for the convenience of administration (Patent Documents 1 to 3). .
  • the solution preparation containing the peptide is generally handled as a syringe loaded in the injection device, and stored at 2-8 ° C. in the refrigerator together with the injection device to avoid freezing.
  • the injection device is taken out of the refrigerator, and after one dose of the drug solution is administered, the injection device is returned to the refrigerator for storage for the next administration. Accordingly, the temperature of the chemical solution in the syringe is generally kept low, and the time for exposure to a temperature other than the predetermined time is short.
  • the syringe containing the drug solution loaded in the injection device is exposed to a temperature outside the predetermined time for a long time. It is also conceivable to store the injection device in the freezer by mistake. Furthermore, the temperature inside the refrigerator may become a predetermined temperature due to a failure, the environment where the refrigerator is installed, the temperature setting in the refrigerator, frequent opening / closing of the refrigerator door, and the like. For example, when the outside air is extremely cold, the temperature in the refrigerator set to 2 to 8 ° C. may be below freezing, and the aqueous solution stored in the refrigerator may freeze.
  • a solution preparation containing a peptide loaded in an injection device when exposed to a temperature other than a predetermined temperature, the peptide may be denatured and the original medicinal effect may be lost. Further, the denatured peptide may induce side effects such as antigen-antibody reaction. When the peptide is denatured, the peptide may aggregate and the solution may become cloudy. However, the appearance of the peptide may not be discernable. In such a case, the risk of injecting the modified peptide is increased. Therefore, strict temperature control is required for storage of solution preparations containing peptides.
  • the solution formulation containing the peptide it may be necessary to carry it outdoors due to the fact that it must be administered after meals.
  • the peptide drug solution for multiple doses is stored in a syringe and used by loading it into a dedicated injection device. There is something to do.
  • it is difficult to maintain the peptide solution at a low temperature of 2 to 8 ° C. it should be allowed to be stored at room temperature within a certain period.
  • peptide denaturation may occur when left at room temperature for a certain period of time or when exposed to excessively high temperatures.
  • Pharmaceuticals are not limited to peptide preparations, and the temperature during storage is determined. Therefore, for a pharmaceutical used by being loaded into an injection device, even if it is not a peptide preparation, strict temperature control is similarly required.
  • an object of the present invention is an injection device for injecting a medicine (medicine solution) contained in a syringe, and prevents the heat-denatured medicine from being used by mistake. Therefore, it is an object of the present invention to provide an injection device that issues a warning to a user when exposed to a temperature outside a set temperature range with a syringe containing a medicine loaded for a certain period of time.
  • the present inventors have introduced a temperature sensor to the injection device, and when the temperature sensor detects a temperature outside the preset temperature range, or out of such a set range.
  • a misuse prevention unit that issues a warning and / or prevents the use of the device when the length of time during which the temperature is detected exceeds a preset length of time, it is outside the set range.
  • the present invention has been completed by discovering that it is possible to prevent injection of a drug that has been exposed to the temperature of a certain time for a certain period of time. That is, the present invention provides the following. 1.
  • An injection device for injecting a medicine accommodated in a syringe having a barrel having a front end and a cylindrical side wall and a gasket fitted in the side wall so as to be slidable in a liquid-tight manner.
  • the temperature measuring unit has a temperature sensor, and at least in a state where the syringe is held by the holding unit, the temperature sensed by the temperature sensor is out of a preset temperature range.
  • An injection device that is configured such that the misuse prevention unit can be activated to issue a warning when the error occurs. 2.
  • An injection device for injecting a medicine accommodated in a syringe having a barrel having a front end and a cylindrical side wall and a gasket fitted in the side wall so as to be slidable in a liquid-tight manner.
  • the temperature measuring unit has a temperature sensor, and at least when the temperature sensed by the sensor unit is outside the preset temperature range in a state where the syringe is held by the holding unit. And a timer capable of measuring the length of time during which the temperature sensed by the sensor unit is outside the preset temperature range.
  • prevention portion for said error is configured to be able to issue a warning and activated when exceeding a predetermined time length, the injection device. 3. 3. The injection device according to 1 or 2 above, wherein the warning is caused by any one or a combination of visual indication, luminescent signal, sound, and movement prevention of the piston rod. 4). 4. The injection device according to 3 above, comprising a display monitor, wherein the visual display is displayed on the display monitor. 5. 5. The injection device according to 3 or 4 above, wherein the movement of the piston rod is prevented by engagement of the piston rod and a blocking member. 6). 6. The injection device according to 5 above, wherein the blocking member is a latch claw. 7).
  • control unit includes a motor capable of moving the piston rod forward, and the control unit includes a recording medium on which a program for controlling the motor is recorded.
  • the warning is caused by blocking movement of the piston rod, and blocking movement of the piston rod is performed by cutting off power supply to the drive unit.
  • the holding unit is provided with a sensor for sensing holding of the syringe by the holding unit.
  • the sensor for sensing holding of the syringe is a pressure sensor. 11. Even when the syringe is not attached to the holding part, the misuse prevention part or the timer can be operated when the temperature detected by the temperature sensor is outside the temperature range set in advance. 11.
  • the present invention when using an injection device loaded with a syringe containing a medicine, it is possible to prevent the medicine that has been exposed to a temperature outside the preset range for a certain period of time, and thereby to perform secondary injection. In particular, handling such that the drug is exposed to a temperature outside the preset range can be suppressed. In addition, even when the syringe is not held, when the device is exposed to a temperature outside a preset range (for example, which may adversely affect the structure and function of the device) for a predetermined length of time. The use of the device can be warned or prevented from being used, and secondarily, the handling of the device itself is exposed to temperatures outside such pre-set ranges. it can.
  • the control block diagram which shows typically the structure of the injection apparatus with a temperature measurement part which contains a motor in a drive part of Example 1.
  • FIG. PS indicates a pressure sensor.
  • the flowchart which shows the operation control of the injection apparatus of Example 1.
  • Schematic side cross-sectional view of a syringe loaded in a holder with a double-ended needle attached Schematic side sectional view of the injection device of Example 1 Schematic side view of the injection device of Example 1 Warning display displayed on the LCD panel.
  • the control block diagram which shows typically the structure of the injection apparatus with a temperature measurement part of Example 2 which does not include a motor in a drive part. PS indicates a pressure sensor.
  • the flowchart which shows the operation control of the injection apparatus of Example 2.
  • Schematic sectional view of the injection device of Example 2 Front side end view of injection device of Examples 1 and 2 The perspective view of the L-shaped groove
  • Glow Jector registered trademark
  • the term “injection device” refers to a device that holds a syringe and injects a medicine contained in the syringe, and the syringe includes a front end portion and a barrel portion formed of a cylindrical side wall, And a gasket fitted in the side wall so as to be slidable in a liquid-tight manner.
  • the medicine in the syringe is injected into the patient via the injection needle at the front end of the syringe.
  • the injection needle may be formed integrally with the syringe body so as not to be removable, or may be removable later.
  • a septum through which a double-ended needle can be inserted is provided at the front end of the syringe, and a double-ended needle can be attached during use and removed after use.
  • the double-ended needle should be securely locked to the syringe by providing a male luer or male screw at the front end of the side wall of the barrel of the syringe according to the shape of the female luer or female screw provided on the base that supports the double-ended needle. Can do.
  • the syringe held by the injection device is a two-chamber prefilled chamber whose interior is divided into two front and rear chambers by two gaskets, a front movable wall and a rear movable wall, which are slidably housed in the syringe body. It may be a syringe.
  • Such a two-chamber prefilled syringe is used by storing a dry drug component by freeze-drying or the like in a front space and a liquid drug component for dissolving or suspending it into an injection solution in the rear space.
  • the rear movable wall is pushed in with a piston rod and the components contained in each space are mixed and used (FIG. 1).
  • Such a two-chamber prefilled syringe is that used in Growjector (registered trademark) (Nippon Chemical Research), which is a commercially available growth hormone preparation. Further, the present invention is not limited to this, and the two-chamber prefilled syringe may contain a liquid drug component in any of the front and rear spaces and mix them before using them.
  • the syringe held by the injection device is preferably loaded in a generally cylindrical holder in advance.
  • a holder preferably protects the syringe from an externally applied impact and ensures that the medicine is properly mixed. Since the cross section of the barrel of the syringe is generally circular, if it is loaded as it is into the holder, it may rotate within the holder and the medicine may not be mixed properly.
  • the rotation of the syringe in such a holder is, for example, provided with a protrusion or a protrusion on the outer peripheral surface of the barrel of the syringe, and when the syringe is loaded in the holder, the holder is engaged with the protrusion or the protrusion.
  • One to three such protrusions or protrusions can be provided on the outer peripheral surface of the body of the syringe, or four or more radially.
  • the shape of the tip of the holder is formed so that the syringe can be fixed forward so that it cannot fall off.
  • an approximately circular hole for exposing the injection needle to the outside of the holder is provided at the tip of the holder so that injection into the patient is possible with the syringe held in the holder, and the inner diameter of this hole is set to the syringe.
  • the inner surface is compatible with a screwing method (luer lock method) around the female luer so that the double-ended needle can be fixed.
  • An annular protrusion having an internal thread may be provided at the tip of the holder.
  • an internal thread may be provided on the inner peripheral surface of the base that supports the double-ended needle, and an external thread that is screwed into the internal thread may be provided at the tip of the holder.
  • FIG. As a two-chamber prefilled syringe loaded in such a holder, a commercially available one is 8 mg for Gloject BC injection (Nippon Chemical Research Co., Ltd.).
  • the syringe held in the injection device or the syringe loaded in the holder can be attached so that it cannot be removed once attached to the injection device, or it can be detachably attached to the injection device.
  • the syringe can be removed from the injection device after the medicine has been used up or after a single dose has been completed, and the syringe can be attached again for the next use, so the injection device is repeated. It can also be used.
  • the injection device is provided with a holding unit for holding the syringe (as it is or loaded in the holder).
  • the holding part is designed in accordance with the form of the syringe to be attached (or the holder in which the syringe is loaded).
  • the syringe is held on the holding portion by providing a male screw on the rear outer surface of the syringe (or a holder in which the syringe is loaded) and screwing it onto a female screw provided on the holding portion of the injection device. Can do.
  • the syringe can also be held on the holding portion by providing a protrusion on the rear outer surface of the syringe (or a holder loaded with the syringe) and fitting the protrusion into a groove provided on the holding portion.
  • the syringe can be held on the holding portion by an appropriate latch.
  • the syringe can contain multiple doses of drug for convenience during administration. In this case, once the syringe is held, it is handled as it is integrated with the syringe until the medicine is used up.
  • the double-ended needle is inserted into the septum of the syringe immediately before injection, and the double-ended needle is inserted after injection.
  • the sample can be extracted and stored in a refrigerator or the like while holding the syringe for the next administration.
  • the syringe may be detachably attached to the injection device or may be detachably attached. In the former, when the medicine is used up, the injection device is discarded together with the syringe. In the latter, when the medicine is used up, the injection device is reused with a new syringe attached.
  • Commercially available Gloject BC 8 mg for injection is the latter type of injection device.
  • injection devices are of a type in which the forward movement of the piston rod is driven by a motor.
  • this type if this is stored in a refrigerator or the like while holding a syringe or a syringe loaded in a holder, there is a risk that condensation will occur on the electronic components including the motor when it is removed from the refrigerator during use. , Not good. Therefore, in the case of this type of injection device, the injection device is stored at room temperature separately from the syringe, and in use, the syringe is taken out of a storage place such as a refrigerator and attached to a holding part for use.
  • the syringe After use, the syringe is removed from the holder, the syringe is stored in a cold place such as a refrigerator, and the injection device is stored separately at room temperature.
  • a cold place such as a refrigerator
  • the injection device is stored separately at room temperature.
  • An example of such an injection device is that used in Growjector (registered trademark) (Nippon Chemical Research Co., Ltd.), which is a commercially available growth hormone preparation.
  • the gasket is pushed forward through a piston rod that pushes the rear side of the gasket.
  • the front end of the piston rod is arranged so that the front surface of the piston rod and the back surface of the gasket are simply in contact with each other. It is also possible to mold the male screw so that the male screw is screwed onto the female screw on the rear side of the gasket.
  • the front end of the piston rod can be an integral part of the rest of the piston rod or a separate member. In this case, the front end of the piston rod is in relation to the rest of the piston rod. If it is attached so that it can freely rotate around the central axis, it can prevent torque from being applied to the gasket even if the latter rotates.
  • the drive unit for moving the piston rod forward moves the piston rod manually or electrically.
  • the drive unit When the drive unit is for manually advancing the piston rod, the drive unit is mainly composed of an injection amount adjusting device and a medicine injection button.
  • the medicine injection button is provided outside the rear end of the injection device, and pushes the piston rod and / or the injection amount adjusting device forward by pushing it forward.
  • the injection amount adjusting device is drawn backward from a predetermined stop position by a distance corresponding to the dose of the drug or moves the piston rod back and forth during drug administration, thereby determining the amount of piston that can be pushed by the piston rod. Therefore, as long as the purpose is achieved, the structure, shape, etc. are not limited.
  • the drug injection button is preferably attached to the injection amount adjusting device so as to be freely rotatable so that no extra torque is applied to the injection amount adjusting device when it is pressed.
  • the injection amount adjusting device is engaged directly or indirectly with the piston rod. For example, at the time of drug administration, the injection amount adjusting device is first pulled backward from a predetermined stop position by a distance corresponding to the dose. The piston rod is provided so as not to move back and forth when the injection amount adjusting device is pulled backward. Next, when the medicine injection button is pressed, the injection amount adjusting device moves forward according to the distance drawn rearward until it reaches a predetermined stop position.
  • the piston rod is directly or indirectly engaged with the injection amount adjusting device so that when the injection amount adjusting device moves forward, the piston rod is pushed forward according to the moving distance, thereby causing the gasket in the syringe to move forward. As a result, the drug is released from the needle.
  • the piston rod moves forward according to the distance the injection amount adjusting device is pulled backward from the predetermined stop position, the dose of the medicine is determined by the rearward drawing distance of the injection amount adjusting device. Can be adjusted.
  • the mechanism for engaging the injection amount adjusting device with the piston rod is not particularly limited. For example, Japanese Patent Application Laid-Open No. 63-501271, Japanese Patent Application Laid-Open No. 4-259470, Japanese Patent Application Laid-Open No.
  • the drive unit When the drive unit is for electrically moving the piston rod forward, the drive unit is mainly composed of a motor capable of moving the piston rod forward to the injection device and a necessary power transmission mechanism (for example, a gear). As the piston rod advances by the rotation of the motor, the gasket is pushed forward accordingly, so that a corresponding amount of drug is released from the injection needle.
  • a gear structure for converting the rotational motion of the motor into the linear motion of the piston can be selected as appropriate from various known structures.
  • a controller for controlling the operation of the motor is connected to the motor.
  • the control unit includes a recording medium and a central processing unit, and a program for applying a desired force to the piston rod by the motor is recorded in advance on the recording medium, and the control unit controls the motor based on the program. .
  • the recording medium contains information on the remaining amount of medication, past medication records, dosage per dose, medication schedule, voltage and / or current applied to the motor, etc. It is possible to record necessary programs and information.
  • the control unit manages and controls information and programs recorded on the recording medium according to the type of injection device.
  • the injection device includes a temperature measuring unit, which includes a temperature sensor.
  • the temperature measuring unit may further include a timer, which measures the length of time during which the temperature sensed by the sensor unit is outside a preset temperature range.
  • the injection device includes a misuse prevention unit.
  • the misuse prevention unit has a length of time (measured by a timer) when the temperature sensed by the sensor unit of the temperature measurement unit goes out of the preset temperature range or outside the temperature range. When a predetermined time length is exceeded, it is activated to issue a warning to the user.
  • the temperature sensor achieves the purpose of preventing the medicine in the syringe held in the injection device from being exposed to a temperature outside the set range (or beyond the set range for a predetermined length of time). Therefore, it is desirable to install in the vicinity of the syringe.
  • a place where a human hand directly touches at the time of injection is not preferable as a position where the temperature sensor is installed because the human body temperature may be detected by the temperature sensor.
  • the temperature range to be measured by the temperature sensor is appropriately changed depending on the type of medicine, the injection device, the material of the holder, etc., for example, -40 to 120 ° C, -30 to 100 ° C And so on.
  • thermocouple a sheathed thermocouple in which a thermocouple element is hermetically filled with an inorganic insulator in a metal protective tube can be suitably used.
  • iron-constantan or copper-constantan can be used as the thermocouple wire.
  • Resistance temperature detectors that incorporate a device made of a substance whose electrical resistance changes with temperature change, for example, a device made of silicon diode, platinum wire, rhodium iron, ceramic thin film, germanium or ruthenium oxide pressure film Or, a thermistor built-in can be used.
  • a device made of a substance whose electrical resistance changes with temperature change for example, a device made of silicon diode, platinum wire, rhodium iron, ceramic thin film, germanium or ruthenium oxide pressure film Or, a thermistor built-in can be used.
  • the temperature sensor is connected to the misuse prevention part through the control part.
  • the control unit can be configured to immediately activate the misuse prevention unit and generate a warning.
  • the temperature sensor can be connected to a timer via the control unit.
  • the control unit activates a timer and measures the length of time when the temperature is outside the preset temperature range.
  • the misuse prevention unit may be configured to operate so that a warning is issued when the length of time exceeds a predetermined time length.
  • the control unit is activated and a warning is issued when the value expressed by the formula using the temperature sensed by the temperature sensor and the time measured by the timer exceeds a certain value.
  • the misuse prevention unit can be configured to operate.
  • the control unit that controls the temperature measurement unit may be provided separately from the control unit for controlling the motor, or the single control unit can control both the temperature measurement unit and the motor.
  • the control unit includes a central processing unit and a recording medium.
  • set temperature range and a predetermined time length that must not be outside such a temperature range (hereinafter referred to as “set time length”) are recorded on the recording medium of the control unit. Is done.
  • the set temperature range is generally preferably 1 to 15 ° C., more preferably 2 to 8 ° C.
  • the set temperature is 1 to 30 ° C., 2 to 30 ° C., 1 to 35 ° C. according to the storage temperature individually permitted in such preparation. , 2 to 35 ° C., etc.
  • the set time length is generally in the range of 1 to 72 hours depending on the type of peptide, dosage form, etc., for example, 1, 2, 6, 12, It is set to an appropriate value such as 24, 48, 72 hours or the like.
  • peptide preparations may be rapidly denatured when exposed to a certain high temperature or higher, setting such a temperature is effective in preventing injection of denatured peptide preparations.
  • setting such a temperature is effective in preventing injection of denatured peptide preparations.
  • the drug may become extremely hot (for example, 70 ° C.) and the components of the drug may be denatured.
  • Such temperature is in the range of 40 to 80 ° C., for example, 40, 50, 60, 70, 80 ° C., etc., depending on the type of peptide when the drug in the syringe held in the injection device is a peptide preparation.
  • the misuse prevention unit can immediately issue a warning without measuring the time with a timer, and when the temperature is detected by setting the set time length to, for example, 0.01 to 1 second. , It can also be set to issue a warning substantially immediately.
  • a warning can be immediately issued when a low temperature below a certain temperature is detected in order to prevent injection of the frozen peptide.
  • a temperature is suitably in the range of 0 to -20 ° C., for example, 0 ° C., ⁇ 2 ° C., ⁇ 4 ° C., ⁇ 10 ° C., ⁇ 20 ° C., etc., depending on the type of peptide, dosage form, etc. Set to a value.
  • the misuse prevention unit may issue a warning when a value indicated by a function of temperature and time exceeds a preset value. For example, [Temperature over the upper limit of the set temperature range (Tm 1 )-Upper limit of the set temperature range (Tm 2 )] is taken on the y axis and time (t) over the upper limit of the set temperature range is taken on the x axis.
  • Tm 1 set temperature range
  • Tm 2 Upper limit of the set temperature range
  • t time over the upper limit of the set temperature range
  • a warning can be issued.
  • the weight corresponding to the measured temperature level is reflected in the timing of issuing the warning.
  • Such calculation can be performed by a central processing unit constituting the control unit.
  • the time measured by the timer the integral value of the function obtained by using the time as one of the parameters (for example, the area S described above), etc., for example, when the temperature measured by the sensor unit is outside the set temperature range.
  • the length of a certain time returns to the set temperature range before reaching the set time length, it can be deleted and returned to the initial state.
  • the temperature sensor senses a temperature outside the set range for a number of times, it returns to the set temperature range before the length of time at that temperature reaches the set time length. As long as there is no warning.
  • data such as the time measured by the timer and the integral value of the function obtained by using the time as one of the parameters (for example, the area S described above), for example, the temperature detected by the sensor unit within the set temperature range
  • the data is recorded on the recording medium of the control unit, and when a temperature outside the set temperature range is sensed again, the data such as the time and integral value of the function during that time are added to the previously recorded record. It can also be recorded. By doing so, it is possible to issue a warning from the control unit to the misuse prevention unit when the sum of the time and the integrated value of the total exceed the set value.
  • the piston rod of the injection device is of the type driven forward by a motor, remove the syringe from the holding part after one use, and place only the syringe in a cold place such as a refrigerator. In some cases, they are stored separately. In such a state where the syringe is removed, the operation of the temperature measuring unit relating to the medicine is unnecessary, and it is preferable that such an extra operation is not performed.
  • Such a configuration is provided with a syringe attachment / recognition recognition unit for recognizing whether or not the syringe is held in the holding unit which is the syringe attachment position of the injection device, and a signal for informing that the syringe has been removed from the syringe attachment / detachment recognition unit.
  • a syringe attachment / recognition unit for recognizing whether or not the syringe is held in the holding unit which is the syringe attachment position of the injection device, and a signal for informing that the syringe has been removed from the syringe attachment / detachment recognition unit.
  • the syringe attachment / recognition unit is, for example, a pressure arranged at an appropriate position of the holding unit so as to sense a change in the pressing force applied to the holding unit due to the attachment / detachment of the syringe to / from the holding unit
  • the pressure sensor that can be used is not particularly limited, but a semiconductor pressure sensor in which a silicon substrate is incorporated in a pressure receiving portion (diaphragm) can be suitably used.
  • the pressure receiving unit is arranged so as to sense a pressing force applied to the holding unit when the syringe is attached to the holding unit.
  • the pressure sensor is an L-shaped groove that comes into contact with a protrusion provided on the base of the syringe holder to fix the syringe to the injection apparatus when the protrusion is fitted in the L-shaped groove of the holding part of the injection apparatus. Attached to the surface.
  • the resistance value of the pressure receiving portion changes due to the distortion of the diaphragm caused by the pressing force, and thereby the attachment / detachment state of the syringe is detected.
  • the misuse prevention unit issues a warning in response to a command from the control unit.
  • the warning can be done by any means that can issue a warning to the user, such as visual display, luminescent signal, and / or audio output.
  • a display monitor is provided as a display device.
  • the display monitor can be provided using a liquid crystal panel, an organic EL panel, or the like at an easily visible portion of the injection device.
  • the display monitor displays that the medicine in the syringe is no longer suitable for use according to a command from the control unit, and the user can know this fact.
  • the visual display can be performed by displaying the character itself or blinking the character display.
  • the warning is divided into two stages, and a preliminary warning is given to notify that the drug in the syringe is no longer suitable for use before the final warning that informs the user that the drug is no longer suitable for use.
  • Such a display may be a bar display, a sector display, or the like with a set upper limit of 100% so that the user can intuitively understand.
  • Such a display is effective as a means for prompting the user to thoroughly control the temperature of the injection device.
  • the liquid crystal display also contains other information related to the injection device, such as the state of attachment of the syringe to the holder, the remaining amount of the medicine, the past medication record, the dosage per dose, the medication schedule, and the voltage applied to the motor. And / or a current value or the like can also be displayed.
  • Growjector registered trademark (Nippon Chemical Research Co., Ltd.) marketed as an electric injection device is, as shown schematically in FIG. 12, information such as the attachment state of the syringe to the holding part and the remaining amount of the medicine.
  • a warning can be issued through the liquid crystal panel.
  • the schematic external perspective view of the Growjector (registered trademark) shown in FIG. 12 is the same as that disclosed as FIG. 1 in the Design Gazette No. 1198737.
  • the injection device When a warning is issued by a luminescent signal, the injection device is provided with a luminescent part.
  • the light emitting unit can be provided at a place where the injection device is easily visible using a small light source such as a light emitting diode.
  • the light emitting unit emits predetermined light so as to notify the user that the medicine is no longer suitable for use according to a command from the control unit.
  • Light emission can be performed, for example, by continuously turning on or blinking a light emitting diode or the like.
  • the warning can be divided into two stages, and a preliminary warning that it will soon be unsuitable for use can be made before the final warning that notifies the user that it is no longer suitable for use.
  • the light emitting part emits light from blue to yellow some time before the set time length is outside the set temperature range, and when the set time length is reached, the light emitting part emits red light.
  • the user can take measures such as returning the syringe to the refrigerator immediately after seeing that the light-emitting portion emits yellow light.
  • the injection device When issuing a warning by sound (including voice), the injection device is provided with an acoustic unit.
  • the acoustic unit is provided in the injection device using a buzzer, a speaker, or the like.
  • the sound unit In response to a command from the control unit, the sound unit emits a sound notifying the user that the medicine is no longer suitable for use.
  • the warning may be divided into two stages and may be configured to give a preliminary warning that it will soon be unsuitable for use before the final warning that informs the user that it is no longer suitable for use. .
  • the misuse prevention unit is provided in the injection device by any one of the display monitor, the light emitting unit, and the acoustic unit, or a combination thereof.
  • the specific configuration of the injection blocking mechanism is not particularly limited as long as the injection device disables the injection of a drug that is no longer suitable for use.
  • a blocking member that can prevent the movement of the piston rod by engaging with the piston rod.
  • the blocking member is not engaged with the piston rod so that the piston rod can be moved.
  • it can be set as the structure which engages the said blocking member with a piston rod, and blocks
  • the shape and structure of the blocking member there is no particular limitation on the shape and structure of the blocking member.
  • a latch that operates under the control of the control unit and engages the latch pawl with the piston rod is suitable. Used for.
  • the blocking mechanism can be, for example, a means for interrupting the current supply to the motor.
  • the injection device is provided with a warning release unit for releasing the warning and blocking mechanism.
  • the warning release unit By operating the warning release unit, the warning disappears, the blocking of the piston rod movement by the blocking mechanism is released, and when the injection device includes a timer, the timer is returned to the initial state.
  • the operation of the warning release unit can be performed by removing the syringe from the injection device or pressing a warning release button provided on the injection device.
  • the warning or the like can be automatically released by removing the syringe from the injection device.
  • the warning release unit is configured not to operate unless the syringe is removed. Such a configuration makes it easy to prevent a situation where the user cancels the warning and continues to use the syringe that is no longer suitable for use, despite the warning.
  • the warning release button is set so that it does not operate after a certain period of time, for example, 30 seconds, after removing the syringe, the user is prompted to prepare a new syringe during that time. be able to.
  • the removal of the injection device from the syringe may be detected by providing the aforementioned attachment / detachment recognition unit.
  • the injection device itself can also be affected when placed in a too hot environment.
  • a material such as a synthetic resin
  • the shape may be deformed by a high temperature. Therefore, an injection device that has been exposed to excessively high temperatures should not be used to administer drugs that require precise dosages.
  • a warning that the injection device should not be used The user's attention can be alerted by issuing. For example, by displaying “This injection device cannot be used”, it is possible to prevent the injection device from being used without knowing it.
  • Warnings and use prohibitions in the event that such an injection device itself is no longer suitable for the specification may be, for example, a separate temperature measurement unit and misuse prevention unit for the injection device if the drug is no longer suitable for injection. This can be achieved by allowing the control unit to control the temperature range setting and time setting.
  • the power supply unit is not particularly limited as long as it can supply power to the injection device, but is preferably a rechargeable battery or a dry battery.
  • the present invention is not limited to this, and external power connected via a DC adapter can also be used as the power supply unit.
  • FIG. 1 is a control block diagram schematically showing an example of the configuration of an injection device with a temperature measurement unit for administering a growth hormone preparation and including a motor in a drive unit.
  • the injection device of the present invention includes a control unit including a central processing unit and a recording medium, a temperature measurement unit including a temperature sensor and a timer, a misuse prevention unit for preventing misuse of the injection device, a power supply unit, and the like.
  • the device is activated by pressing the activation button.
  • the recording medium of the control unit stores a program necessary for the injection device to perform a predetermined operation.
  • the central processing unit includes a microprocessor, and the microprocessor executes the program recorded on the recording medium to control the operation of the injection device. On the recording medium, for example, a value of 2 to 30 ° C. as the first set temperature range relating to the medicine and a value of 3 hours as the set time length associated therewith are recorded, respectively.
  • the recording medium separately records, for example, a value of 2 to 60 ° C. as a second set temperature range relating to the injection device itself, and a value of 0.1 seconds as a set time length associated therewith, for example.
  • the misuse prevention unit includes a display device (here, a liquid crystal panel) for notifying the user when the injection device should not be used.
  • a display device here, a liquid crystal panel
  • the control unit receives the signal, the control unit activates the timer, and when the time measured by the timer exceeds 3 hours, the control unit The display device displays a warning that the injection device cannot be used.
  • the control unit Display a warning. That is, when the temperature detected by the temperature sensor exceeds 60 ° C., the above command is made substantially immediately. At the same time as the warning is displayed on the display device, the device is configured such that the control unit prohibits the power supply from the power supply unit to the motor, and thus the injection device is in an injectable state.
  • control unit when the syringe is attached to the holding unit of the injection device, when the deviation from the first (and in addition to this, the second) set temperature range, and when the syringe is attached If not, the timer is activated only when the temperature deviates from the second set temperature range. Therefore, after injection of the drug, the syringe is removed from the injection device and stored refrigerated, while the injection device is stored at room temperature until the next use, but only the injection device is in the first set temperature range in that state. The timer will not operate if it only deviates from.
  • the holding unit is equipped with a pressure sensor that measures the pressure applied to the holding unit by attaching a syringe under the control of the control unit, and when the pressure on the pressure sensor becomes substantially equal to zero, The unit receives a corresponding signal from the pressure sensor, and determines that the syringe has been removed from the holding unit.
  • the timer will not operate unless the temperature of the injection device is outside the second set temperature range.
  • the pressure sensor detects the pressure, and the control unit that receives the corresponding signal determines that the syringe is attached to the holding unit, and deviates from the first set temperature range.
  • the timer is immediately put into a ready standby state.
  • the user of the injection device removes the syringe from the holding unit in accordance with the warning display instructions when the misuse prevention unit is activated and a warning is displayed on a display device such as a liquid crystal panel.
  • the holding unit is provided with a pressure sensor for measuring the pressure applied from the syringe to the holding unit, and when the pressure on the pressure sensor becomes almost equal to zero by removing the syringe, a signal indicating that is sent to the control unit.
  • the control unit determines that the syringe has been removed from the holding unit.
  • the injection device is provided with a warning release unit under the control unit, and the warning release unit is provided with a warning release button.
  • pressing the warning release button clears the warning display and cancels the prohibition of power supply to the motor.
  • the warning is locked and is not released even when the warning release button is pressed, and the prohibition of power supply to the motor is not released. In this way, injection can be prevented without replacing the syringe.
  • the central processing unit determines that the syringe is attached, and the control unit initializes time data recorded for the previous syringe. , Set the timer to the new standby state.
  • the syringe Prior to injection, the syringe is fitted with a double-ended needle at the tip, and the injection needle is inserted into the user's body.
  • the motor is driven by the control unit, and the piston rod is pushed forward in conjunction with this.
  • the tip of the piston rod is in contact with the back of the gasket in the syringe at the front and pushes it forward with a predetermined pressing force.
  • the recording medium of the injection device stores information on dosage per dose, dosing schedule, voltage and / or current applied to the motor, and a program for operating the injection device.
  • the central processing unit executes the program recorded on the recording medium, and one medicine is pushed out from the syringe through the injection needle.
  • the injection needle After injection of the drug, the injection needle is removed, and then the syringe is removed from the holding part and stored in the refrigerator until the next use.
  • the injection device is stored at room temperature, and the syringe is newly attached to the holding portion of the injection device at the next use.
  • FIG. 2 is an example of a flowchart showing a series of operations of the injection apparatus of FIG.
  • the pressure sensor provided in the holding unit senses the pressing force applied from the syringe to the holding unit, and the timer enters a standby state. In this state, if the injection device is left in an environment where the temperature exceeds 30 ° C, the timer starts measuring the time when the temperature measured by the temperature sensor exceeds 30 ° C, and the temperature exceeds 30 ° C. Keep measuring time as long as you can. When the time length thus measured exceeds 3 hours, the control unit displays a warning on the liquid crystal panel and prohibits power supply to the motor.
  • the warning display and the prohibition of power supply to the motor are locked, and cannot be released simply by pressing the warning release button.
  • the timer During the time measurement by the timer, when the temperature measured by the temperature sensor falls below 30 ° C in less than 3 hours, the timer returns to the standby state and the time measurement stops, but the time length measured so far The data is stored, and when the temperature rises above 30 ° C again, the time measurement starts again.
  • the timer is set to standby and the time length data measured so far May be initialized to zero.
  • a warning display is immediately displayed on the liquid crystal panel without requiring the pressure sensor to detect pressure, and the motor is turned on.
  • the control unit is configured to cut off the power supply.
  • the user of the injection device can know this by the warning display.
  • the pressure sensor detects that the pressing force has become almost zero, and the warning display is unlocked.
  • the warning release button is pressed in this state, the warning display disappears and the prohibition of power supply to the motor is also released.
  • a new syringe is attached to the holding part of the injection device, and injection is performed.
  • FIG. 3 shows an example of the syringe 2 loaded in the holder 1 with the double-ended needle 3 attached.
  • the tip of the holder 1 is formed in a shape in which the syringe 2 is fixed to the front so as not to drop off.
  • the holder 1 includes an annular protrusion 4 having an outer thread formed on the outer peripheral surface at the front end so that the double-ended needle 3 inserted into the septum 5 at the front end of the syringe can be fixed to the front end.
  • the double-ended needle 3 has a base portion 3a that supports it at the center.
  • the base portion is cylindrical and has an internal thread formed on the inner peripheral surface, and is screwed onto the external thread formed on the annular protrusion 4 of the holder.
  • the double-ended needle is not yet attached to the syringe.
  • a gasket 6 is fitted inside the syringe so as to be fluid-tight and move forward along the inner wall of the syringe, and a medicine 8 is filled in the front thereof.
  • a syringe for example, there is a syringe filled with a growth hormone preparation having the composition shown in Table 1, which needs to be stored in a refrigerator (2 to 8 ° C.).
  • the syringe is made of hard borosilicate glass having an inner diameter of 9.8 mm, and the gasket is made of chlorinated butyl rubber.
  • FIG. 4 is a schematic cross-sectional view of the injection device of this example.
  • the injection device includes a control unit 10, a temperature sensor 12, a timer 13, a motor 14, a piston rod 16, and a pressure sensor 18 inside.
  • the piston rod 16 is advanced through an appropriate power transmission mechanism (for example, a combination of gears) 20.
  • the syringe placed in the holder 1 is taken out of the refrigerator and attached to the holding unit 9a of the injection device stored at room temperature.
  • the base of the holder is provided with a pair of protrusions 7 protruding outward.
  • a pair of grooves through which the pair of protrusions 7 pass is formed in the longitudinal direction through the tip of the holding part (24, FIG. 10), It bends in the lateral direction at the back and stops, forming an L-shaped groove 24 (FIG. 11) as a whole.
  • the holder protrusion is held in the holding portion together with the syringe by the protrusions of the holder being passed through these L-shaped grooves and rotated in the horizontal direction at the back.
  • a pressure sensor 18 is provided on the inner wall at the end at the back of the L-shaped groove at a position to receive a pressing force from the fitted protrusion. The pressure sensor is connected to the control unit 10.
  • a temperature sensor 12 is provided near the front side inside the injection apparatus, and this is also connected to the control unit.
  • the piston rod 16 for pushing the gasket of the syringe advances the piston rod by a distance proportional to the rotation amount (°) of the shaft of the motor 14 in accordance with a proportional constant determined by the reduction ratio of the power transmission mechanism 20.
  • the control unit uses this proportionality constant and the advance distance of the piston rod required for each administration of the drug to control the amount of rotation (°) of the motor, thereby controlling the movement distance of the piston rod.
  • the amount of drug injection can be controlled.
  • FIG. 5 shows an example of a side view of the injection device 9.
  • a liquid crystal panel 26 as a display device is provided outside the injection device.
  • the liquid crystal panel 26 is under the control of the control unit, and displays a warning according to a command from the control unit.
  • 6A and 6B show examples of warnings displayed on the liquid crystal panel 26.
  • FIG. 6 (a) "This drug cannot be used. Please replace the drug.”
  • b) it is displayed in plain expression using hiragana.
  • the plurality of display contents are recorded in advance on the recording medium so that the display contents can be changed.
  • information about the state of the injection device for example, temperature
  • All of these displays are also performed according to commands from the control unit.
  • a warning release button 28 is provided outside the injection device.
  • the warning release button 28 forms part of the warning release unit under the control of the control unit.
  • the injection device is configured such that once the warning is issued, the control unit does not permit the warning to be released even if the warning release button is pressed, unless the syringe is removed.
  • An activation button 30 for switching ON / OFF of the entire injection device is provided outside the injection device.
  • a drug injection button 32 for starting injection of a drug into the patient is provided at the rear end (opposite side of the holding unit) of the injection device.
  • FIG. 7 is a control block diagram schematically showing an example of the configuration of the injection device 34 with a temperature measurement unit that does not include a motor in the drive unit of Example 2 that is a type in which an injection operation is manually performed.
  • the configuration and functions of the parts other than the mechanism for controlling the motor and transmitting the power of the motor to the piston rod are the same as those of the injection unit that includes the motor in the drive unit of the first embodiment. This is basically the same for devices.
  • the injection device of the present embodiment includes a control unit including a central processing unit and a recording medium, and the operation of each part of the injection device is controlled by a program recorded on the recording medium by the microprocessor of the central processing unit. .
  • a control unit including a central processing unit and a recording medium
  • the operation of each part of the injection device is controlled by a program recorded on the recording medium by the microprocessor of the central processing unit.
  • values of 2 to 30 ° C. as the first set temperature range relating to the medicine and 3 hours as the set time length associated therewith are recorded.
  • the recording medium separately records a value of 2 to 60 ° C. as the second set temperature range relating to the injection device itself, and a value of 0.1 seconds as the set time length associated therewith. .
  • the control unit When the temperature detected by the temperature sensor exceeds 30 ° C, the control unit receives the signal, the control unit activates the timer, and when the time measured by the timer exceeds 3 hours, the control unit , A warning that the injection device is unusable is displayed.
  • the control unit displays a predetermined warning on the display device. Let That is, when the temperature detected by the temperature sensor exceeds 60 ° C., the above command is made substantially immediately.
  • the injection device is configured such that a warning is displayed on the display device, and at the same time, the control unit disables the piston rod from being pushed in (and therefore cannot be injected).
  • an electromagnetic latch described later using a latch claw as a blocking member that operates under the control of the control unit so as to be engaged with the piston rod.
  • the user of the injection device removes the syringe from the holding unit in accordance with the warning display instructions when the misuse prevention unit is activated and a warning is displayed on the display device (liquid crystal panel).
  • the holding unit is provided with a pressure sensor for measuring the pressure applied from the syringe to the holding unit, and when the pressure on the pressure sensor becomes almost equal to zero by removing the syringe, a signal indicating that is sent to the control unit.
  • the control unit determines that the syringe has been removed from the holding unit.
  • the warning display disappears by pressing the warning release button, and the engagement between the latch claw and the piston rod is released.
  • the control unit determines that the syringe has been removed from the holding unit, the warning is locked and is not released even when the warning release button is pressed, and the engagement of the latch claw with the piston rod is not released.
  • the central processing unit determines that the syringe is attached, and the control unit initializes time data recorded for the previous syringe. , Set the timer to the new standby state.
  • the injection amount adjusting device 34 included in the injection device of this embodiment is rotated counterclockwise as viewed from the rear of the injection device. By this rotation, the injection amount adjusting device protrudes backward from the injection device while retreating from the piston rod from a predetermined stop position.
  • a scale is attached to the side of the injection amount adjusting device so as to correspond to the amount of liquid to be injected, and the injection amount adjusting device is rotated until the scale indicates a desired dose.
  • a double-ended needle is attached to the tip of the syringe, the injection needle is inserted into the user's body, and then the medicine injection button is pressed, whereby the injection amount adjusting device moves forward to the stop position.
  • the injection amount adjusting device is engaged with the piston rod, the piston rod is pushed forward by that amount, and a corresponding amount of medicine is injected from the injection needle.
  • the injection needle After injection of the drug, the injection needle is removed, and then the syringe is removed from the holding part and stored in the refrigerator until the next use. On the other hand, the injection device is stored at room temperature. At the next use, the syringe is reattached to the holding part of the injection device.
  • FIG. 8 is an example of a flowchart showing a series of operations of the injection apparatus of FIG.
  • the pressure sensor provided in the holding unit senses the pressing force applied from the syringe to the holding unit, and the timer enters a standby state. In this state, if the injection device is left in an environment where the temperature exceeds 30 ° C, the timer starts measuring the time when the temperature measured by the temperature sensor exceeds 30 ° C, and the temperature exceeds 30 ° C. Keep measuring time as long as you can.
  • the control unit displays a warning on the liquid crystal panel and operates the electromagnetic latch to engage the latch claw with the piston rod.
  • the warning display and latch pawl engagement are locked, and cannot be released simply by pressing the warning release button.
  • the timer During the time measurement by the timer, when the temperature measured by the temperature sensor falls below 30 ° C in less than 3 hours, the timer returns to the standby state and the time measurement stops, but the time length measured so far The data is stored, and when the temperature rises above 30 ° C again, the time measurement starts again.
  • the timer is set to standby and the time length data measured so far May be initialized to zero.
  • the controller is configured to operate and engage the latch pawl with the piston rod.
  • the user of the injection device can know this by the warning display.
  • the pressure sensor detects that the pressing force has become almost zero, and the warning display and the latch claw engagement are unlocked.
  • the warning release button is pressed in this state, the warning display disappears, the electromagnetic latch returns to its original position, and the latch claw disengages from the piston rod.
  • a new syringe is attached to the holding part of the injection device, and injection is performed.
  • FIG. 9 is a schematic cross-sectional view of the injection device of this example.
  • the injection device is provided with a control unit 10, a temperature sensor 12, a piston rod 36, a pressure sensor 18, and an electromagnetic latch inside, and the electromagnetic latch is provided with a latch claw 40.
  • the syringe is taken out of the refrigerator and attached to the holding unit 9a of the injection device stored at room temperature.
  • a pair of protrusions 7 are provided at the base of the holder, and these protrusions are fitted into an L-shaped groove 24 formed in the holding part of the injection device, so that the syringe is held in the holding part together with the holder. .
  • a pressure sensor is provided on the inner wall of the L-shaped groove 24 at a position where a pressing force is received from the fitted protrusion.
  • the pressure sensor 18 is connected to the control unit 10 provided inside the injection device.
  • a temperature sensor 22 provided near the front side inside the injection apparatus is also connected to the control unit.
  • a male screw 42 is formed in the latter half region of the piston rod 36 for pushing the gasket of the syringe.
  • the injection amount adjusting device 34 has a female screw 44 formed on its inner wall surface, and the female screw 44 is rotatably engaged with a male screw 42 formed on a piston rod.
  • the piston rod 36 can be moved forward by a piston rod support member 46 provided at an intermediate position between the holding portion in the injection device and the injection amount adjusting device, but the backward movement and rotation are limited.
  • the piston rod support member 46 is provided with a piston rod passage hole 47 that matches the shape of the cross section of the piston rod for allowing the piston rod to pass therethrough.
  • a longitudinal groove is formed in the piston rod 36.
  • the piston rod passage hole is provided with a movable projection (not shown) that fits into the vertical groove, thereby preventing the piston rod from rotating.
  • a series of check claws arranged in the longitudinal direction is provided in the longitudinal groove of the piston rod, and the movable projection is one of the series of check claws when the syringe is attached to the injection device. Projects into the hole until it engages, preventing the piston rod from moving backwards.
  • the movable protrusion retracts to the extent that it does not engage with the check pawl and allows the piston rod to move backward, but still remains in the longitudinal groove and the piston rod rotates. Keeps blocking. That is, the position of the movable protrusion is switched depending on whether or not the syringe is attached to the injection device.
  • the above-described electromagnetic latch may be used instead of such a series of check pawls and movable protrusions. This is because, for example, when the syringe is attached, the control unit operates the electric latch to keep the latch claw 40 engaged with the male screw 42 of the piston rod.
  • the piston rod push-in button 56 at the rear end is pressed, it can be achieved by programming to release the electric latch and allow the piston rod to advance unless a warning is issued.
  • the injection amount adjusting device when the injection amount adjusting device is rotated counterclockwise as viewed from the rear of the injection device from a predetermined stop position and retracted by a desired distance with respect to the piston rod 36, the injection amount adjusting device protrudes from the rear of the injection device by that amount. .
  • the injection amount adjusting device when the double-ended needle attached to the front end of the syringe was inserted into the patient's skin and the rear end of the injection amount adjusting device was pushed back to the stop position, the injection amount adjusting device was retracted.
  • the piston rod moves forward by the same distance, the gasket is pushed in, and one dose of medicine is ejected from the injection needle.
  • the electromagnetic latch in the present embodiment includes a bar 50 that can rotate within a predetermined range with the center as a fulcrum, and the fulcrum 52 is provided at a position away from the inner wall surface of the injection device. Yes.
  • the electromagnetic latch is not activated, the bar is supported against the inner wall surface by a spring 53 so as to be substantially parallel to the piston rod.
  • a latch claw 40 is provided at one end of the bar, and the tip of the bar faces a male screw 42 on the side of the piston rod.
  • the part of the latch claw opposite to the fulcrum is formed using a ferromagnetic material.
  • the inner wall of the injection device is provided with an electromagnet 54 facing the ferromagnetic part of the bar, which is under the control of the control unit.
  • the electromagnet 54 overcomes the force of the spring and attracts the ferromagnetic portion of the bar, thereby rotating the bar and causing the latch pawl 40 to move to the thread of the male thread 42 of the piston rod. Engage to prevent movement of the piston rod.
  • the control unit cuts off the current to the electromagnet, the latch returns to the original position by the force of the spring.
  • a warning release button is provided outside the injection device.
  • the injection device is controlled so that the warning cannot be released even if the warning release button is pressed unless the syringe is removed after the warning display is issued.
  • the present invention is useful as an injection device that can prevent injection of drugs exposed to high or low temperatures inappropriate for storage.

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Abstract

La présente invention concerne un dispositif d'injection qui génère une alarme pour l'utilisateur lorsqu'il est exposé pendant au moins une durée définie à une température extérieure à une plage de température définie lorsqu'il est sous la forme d'une seringue qui contient un médicament ayant été chargé. Le dispositif d'injection est destiné à injecter un médicament contenu dans la seringue, qui a une section de corps comprenant une extrémité avant et une paroi latérale tubulaire, et un joint, qui est installée de façon coulissante à l'intérieur de la paroi latérale d'une manière hermétique aux fluides, où : le dispositif d'injection a une section de maintien, qui est destinée à maintenir la seringue, une tige de piston, qui peut presser le joint vers l'avant, une unité d'entraînement, qui est destinée à amener la tige de piston à progresser vers l'avant, une unité de mesure de température, qui a la fonction de détection de la température, et une unité de prévention d'utilisation erronée ; l'unité de mesure de température a un capteur de température ; et la configuration est telle qu'au moins lorsque la seringue est maintenue à la section de maintien, et lorsque la température détectée par le capteur de température devient extérieure à une plage de température prédéfinie, l'unité de prévention d'utilisation erronée peut actionner et générer une alarme.
PCT/JP2012/079737 2011-11-20 2012-11-16 Dispositif d'injection pourvu d'une unité de mesure de température WO2013073650A1 (fr)

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CN110201269A (zh) * 2019-05-31 2019-09-06 江苏德尔福医疗器械有限公司 多功能注射装置
CN110621366A (zh) * 2017-03-31 2019-12-27 贝克顿·迪金森公司 智能可穿戴式注射和/或输注装置
CN112168712A (zh) * 2020-11-09 2021-01-05 四川省肿瘤医院 一种电动鼻饲胃管注射装置

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CN112168712A (zh) * 2020-11-09 2021-01-05 四川省肿瘤医院 一种电动鼻饲胃管注射装置

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