WO2023132104A1 - Dispositif d'administration de médicament liquide, son procédé de commande et système d'administration de médicament liquide - Google Patents

Dispositif d'administration de médicament liquide, son procédé de commande et système d'administration de médicament liquide Download PDF

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Publication number
WO2023132104A1
WO2023132104A1 PCT/JP2022/034106 JP2022034106W WO2023132104A1 WO 2023132104 A1 WO2023132104 A1 WO 2023132104A1 JP 2022034106 W JP2022034106 W JP 2022034106W WO 2023132104 A1 WO2023132104 A1 WO 2023132104A1
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WO
WIPO (PCT)
Prior art keywords
solution
movable
reservoir
administration device
drug
Prior art date
Application number
PCT/JP2022/034106
Other languages
English (en)
Japanese (ja)
Inventor
祐介 薬師寺
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2023572350A priority Critical patent/JPWO2023132104A1/ja
Publication of WO2023132104A1 publication Critical patent/WO2023132104A1/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
    • A61M5/14—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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • 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

Definitions

  • the present disclosure relates to a medical solution administration device, its control method, and a medical solution administration system.
  • Patent Literature 1 describes a configuration related to a drug-solution administration device.
  • An object of the present disclosure is to provide a drug-solution administration device, a control method thereof, and a drug-solution administration system capable of shortening the time required to restart drug-solution administration when the drug-solution administration is interrupted.
  • a medical-solution administration device is a medical-solution administration device that administers a medical solution filled in a reservoir into a living body by a pressing action of a plunger, comprising: the reservoir filled with the medical solution; the plunger that is provided in the reservoir and is movable in the longitudinal direction of the reservoir; a movable portion that is capable of pressing the plunger toward the distal end side of the reservoir by moving in the movable region; a driving unit that moves in an area; a detection unit that can detect the movable unit at a predetermined detection position in the movable area; The movable part is moved in a direction opposite to the distal end side until the detection part detects the movable part, and based on a first movement amount, which is a movement amount in the opposite direction, the chemical solution remains in the reservoir.
  • Estimate quantity is a first movement amount, which is a movement amount in the opposite direction, the chemical solution remains in the reservoir.
  • control section moves the movable section from the detection position to the distal end side by the first movement amount, and after the movement, until the flow path in the liquid medicine administration device is filled with the liquid medicine. and controlling the drive unit so as to move the movable unit toward the distal end by a second movement amount and then restart the administration of the liquid medicine.
  • the driving section moves the movable section by transmitting a driving force based on the rotation of a motor
  • the control section controls the detection position and the movable section by the first movement amount. and the number of rotations of the motor required for moving the movable portion by the second movement amount.
  • a plurality of the detection units capable of detecting the movable portion at the detection positions different from each other are provided, and the control unit responds to resuming the interrupted drug solution administration. Then, the movable portion is moved in a direction opposite to the distal end side until any one of the plurality of detection portions detects the movable portion.
  • a disposable cartridge and a reusable device main body detachably provided on the cartridge are provided, and the reservoir, the plunger, the movable part, the driving part, the detection part, and the A control unit is provided in each of the cartridge and the device main body, and the control unit controls the detection position at the detection position in response to reconnection of the cartridge and the device main body that were disconnected during drug solution administration.
  • the movable part is moved in a direction opposite to the distal end side until the detection part detects the movable part, the residual amount of the chemical solution in the reservoir is estimated based on the first movement amount, and the residual amount is Based on this, the driving unit is controlled so as to restart the administration of the liquid medicine.
  • the estimated remaining amount of the chemical liquid is displayed on the display device.
  • a medical-solution administration system includes the medical-solution administration device described above and a remote control for a user to operate the medical-solution administration device.
  • a control method for a drug-solution administration device includes a reservoir filled with a drug solution, a plunger provided in the reservoir and movable in the longitudinal direction of the reservoir, and a plunger moving in a movable region. a movable part capable of pressing the plunger toward the distal end of the reservoir; a driving part for moving the movable part in the movable area; and detecting the movable part at a predetermined detection position in the movable area.
  • FIG. 10 is a diagram showing an example of a cartridge in which the nut portion is in the non-contact position;
  • FIG. 10 is a diagram showing an example of a cartridge with a nut portion in a predetermined position;
  • FIG. 2 is a block diagram showing an example of a configuration related to control of the drug-solution administration device of FIG. 1;
  • FIG. 2 is a block diagram showing an example of the hardware configuration of the remote control shown in FIG. 1;
  • FIG. 2 is a flow chart showing an operation procedure of the drug-solution administration device of FIG.
  • 2 is a flow chart showing an operation procedure of the drug-solution administration device of FIG. 1; 2 is a flow chart showing an operation procedure of the drug-solution administration device of FIG. 1; 2 is a flow chart showing an operation procedure of the drug-solution administration device of FIG. 1;
  • FIG. 1 is a diagram showing an example of a drug-solution administration system 100 according to one embodiment.
  • the drug solution administration system 100 administers a drug solution such as insulin into the patient's body.
  • a drug-solution administration system 100 includes a drug-solution administration device 10 and a remote controller 90 .
  • the drug solution administration device 10 is a device that continuously or intermittently administers the drug solution filled in the reservoir into the living body by the pressing action of the plunger.
  • the drug-solution administration device 10 may be, for example, a portable device that can be attached to the patient's abdomen (patch type).
  • the drug-solution administration device 10 is not limited to a patch type, and may be a tube type or the like.
  • the remote control 90 is a device for a user such as a patient to operate the drug-solution administration device 10 .
  • the remote controller 90 notifies the user of information received from the medical-solution administration device 10 and accepts user's operations on the medical-solution administration device 10 .
  • the remote controller 90 is implemented by a dedicated device compatible with the drug-solution administration device 10, but may be implemented by a general-purpose information processing device such as a smart phone or a tablet. Further, in this embodiment, an example in which the remote controller 90 serves as a user interface such as notifying the user of information and receiving information input from the user will be described.
  • the functions may be provided in the drug-solution administration device 10 .
  • the medicinal-solution administration device 10 and the remote controller 90 are communicably connected to each other via a wireless communication line, a wired communication line, or a combination thereof.
  • a wireless communication line a wireless communication line
  • a wired communication line a wired communication line
  • FIG. 2 is a diagram showing an example of an exploded perspective view of the drug-solution administration device 10 of FIG.
  • FIG. 3 shows an example of the cartridge 12 with the nut portion 24 at the non-contact position.
  • FIG. 4 shows an example of the cartridge 12 with the nut portion 24 at a predetermined position.
  • the drug-solution administration device 10 includes a disposable cartridge 12 and a reusable device main body 14.
  • the cartridge 12 has a flat box-shaped base portion 16 which is open on one side.
  • the base portion 16 has a substantially rectangular shape in plan view.
  • the base portion 16 may be detachably provided to a cradle (not shown) that can be attached to the patient's skin.
  • the cradle may include a cannula that is left in vivo.
  • the base portion 16 includes a reservoir 18 filled with a chemical solution, a plunger 20 provided in the reservoir 18, a feed screw shaft 22 coaxially arranged with the plunger 20, and a feed screw shaft.
  • a nut portion (movable portion) 24 that is screwed onto 22 is provided.
  • Base portion 16 is configured as a disposable member.
  • the reservoir 18 extends cylindrically in the longitudinal direction of the base portion 16 .
  • the distal end portion of the reservoir 18 has an outer diameter and an inner diameter that decrease toward the distal end.
  • An introduction port 26 for introducing the chemical solution into the reservoir 18 and an extraction port 28 (see FIG. 3) for extracting the chemical solution from the reservoir 18 are formed at the tip of the reservoir 18. .
  • the lead-out port 28 communicates with a lead-out tube 29 that guides the drug solution in the reservoir 18 to the cannula.
  • the plunger 20 is integrally formed of a resin material or the like, and is provided in the reservoir 18 so as to be liquid-tight and slidable along the axial direction of the reservoir 18 .
  • the plunger 20 has a plunger main body 30 forming a tip side, and a pusher 32 provided on the plunger main body 30 and forming a rear end side.
  • a seal member 34 is attached to the rear end side of the plunger main body 30 which is formed in a cylindrical shape.
  • the pusher 32 has a pair of extensions 36 extending rearward from the plunger body 30 to the outside of the reservoir 18 and a pair of claws 38 provided at the rear ends of the extensions 36 .
  • One end of the feed screw shaft 22 is rotatably supported by a bearing 39 and constitutes a drive section 40 that moves the nut section 24 .
  • the drive unit 40 includes a battery 42 as a power source, a motor 44 driven by the battery 42, a gearbox (power transmission mechanism) 46 that reduces the rotational driving force of the motor 44 and transmits it, and an output gear 48 of the gearbox 46. It further has a transmission shaft 52 to which a spur gear 50 meshing with is fixed and locked to the feed screw shaft 22 so as to be integrally rotatable.
  • the battery 42 and transmission shaft 52 are provided in the cartridge 12, and the motor 44 and gear box 46 are provided in the device body 14.
  • the battery 42 is provided with a terminal 54 electrically connected to the motor 44 of the device body 14 when the device body 14 is connected to the cartridge 12 .
  • the transmission shaft 52 is supported by a pair of bearings 56 provided on the base portion 16 while being coaxial with the feed screw shaft 22 .
  • the motor 44 When the motor 44 rotates, its rotational force is transmitted to the feed screw shaft 22 , and the rotation of the feed screw shaft 22 causes the nut portion 24 to move toward or away from the plunger 20 .
  • the rotation of the motor 44 for moving the nut portion 24 toward the plunger 20 will be referred to as forward rotation
  • the rotation of the motor 44 in the direction opposite to the forward rotation will be referred to as reverse rotation.
  • the motor 44 is configured to rotate both forward and reverse.
  • the motor 44 is configured so that the rotational driving force is not transmitted to the components below the gear box 46 when a certain force or more is applied to the forward or reverse rotation.
  • a stepping motor for example, may be employed as the motor 44 .
  • a rotary encoder (not shown) is provided on the output shaft of the motor 44, and it is possible to determine whether the motor 44 is out of sync with the input pulse (step out) by detecting the rotation of the motor 44 with the rotary encoder. The operating state of the motor 44 is transmitted to the control section 71 as a rotary encoder output.
  • the nut portion 24 is integrally molded from a resin material and has a nut portion main body 58 formed in a substantially rectangular parallelepiped shape and a slide portion 60 provided on the nut portion main body 58 .
  • the nut main body 58 is formed with a threaded hole 62 into which the feed screw shaft 22 is screwed, and a pair of through holes 64 which are formed to sandwich the threaded hole 62 from both sides and through which the claws 38 are inserted.
  • a reinforcing cover 66 made of, for example, a metal material is attached to the outer surface of the nut body 58 .
  • the slide portion 60 slides on a guide wall 68 provided on the base portion 16 and extending along the axial direction of the plunger 20 . That is, the nut portion 24 is in a non-contact position (see FIG. 3) where it does not contact the plunger 20 before use. Then, the plunger 20 is pushed forward (see FIG. 4).
  • the apparatus main body 14 includes a lid body 70 detachably provided on the base portion 16 so as to close the opening of the base portion 16, a control portion 71, a storage portion 72, A communication unit 73 , a position detection unit 74 , and an orientation detection unit 75 are provided.
  • the motor 44, storage unit 72, communication unit 73, position detection unit 74, and orientation detection unit 75 are electrically connected to the control unit 71 via a bus 79 (see FIG. 5).
  • the control unit 71 controls each part of the medicinal-solution administration device 10 and executes processing related to the operation of the medicinal-solution administration device 10 .
  • the control unit 71 drives and controls the motor 44 based on information regarding drug solution administration transmitted from the remote controller 90 .
  • the position detection portion (detection portion) 74 is a sensor that detects the position of the nut portion 24 in the axial direction of the plunger 20 .
  • the position detection section 74 may detect the position of the nut section 24 by detecting the position of the slide section 60 on the guide wall 68, for example.
  • the position detection part 74 is provided at intervals along the guide wall 68, and is capable of detecting the nut part 24 at each corresponding detection position. may be configured.
  • Each of the plurality of position detection units 74a to 74d may be realized by contact sensors, for example. In this case, the position detection section 74 can detect the position of the nut section 24 corresponding to one of the plurality of contact sensors based on detection of the contact of the slide section 60 .
  • the position detection portion 74 By configuring the position detection portion 74 as a plurality of position detection portions 74a to 74d in this manner, the position of the nut portion 24 in the axial direction of the plunger 20 can be easily detected.
  • the configuration of the position detection portion 74 is not limited to a contact sensor configuration as long as the position of the nut portion 24 can be detected.
  • a configuration using a non-contact sensor using magnetic field detection combining a magnetic field generation source such as a magnet and a Hall element, or light detection combining a light source such as an LED and a light receiving element, or the like may be used.
  • position detection of the slide portion 60 and position detection of the nut portion 24 are synonymous.
  • FIG. 5 is a block diagram showing an example of a configuration related to control of the medicinal-solution administration device 10 of FIG.
  • the motor 44 , the storage unit 72 , the communication unit 73 , the position detection unit 74 , and the orientation detection unit 75 are electrically connected to the control unit 71 via the bus 79 .
  • the control unit 71 is one or more processors.
  • the control unit 71 is communicably connected to each component constituting the drug-solution administration device 10 and controls the operation of the drug-solution administration device 10 as a whole.
  • the processor is a general-purpose processor such as a CPU (Central Processing Unit) or a dedicated processor specialized for specific processing.
  • the controller 71 may include one or more dedicated circuits, or one or more processors may be replaced with one or more dedicated circuits in the controller 71 .
  • the dedicated circuit is, for example, an FPGA (Field Programmable Gate Array).
  • the storage unit 72 is one or more semiconductor memories, one or more magnetic memories, one or more optical memories, or a combination of at least two of them.
  • the semiconductor memory is, for example, RAM (Random Access Memory) or ROM (Read Only Memory).
  • the storage unit 72 functions as, for example, a main memory device, an auxiliary memory device, or a cache memory.
  • the storage section 72 may store information from the control section 71 .
  • Information stored in storage unit 72 may be transmitted to remote controller 90 via communication unit 73 under the control of control unit 71 .
  • the communication unit 73 is a communication interface for communicating with the remote control 90.
  • the communication unit 73 communicates with the remote controller 90 via Bluetooth (registered trademark), but is not limited to this, and communicates via other wireless communication paths such as a wireless LAN (Local Area Network) or a wired cable, for example. You may
  • the medicinal-solution administration device 10 may be provided with a posture detection unit 75 that is a device for detecting the posture of the medicinal-solution administration device 10 .
  • the orientation detection unit 75 may be realized by a triaxial acceleration sensor, a gyro sensor, or the like.
  • Control of the medicinal-solution administration device 10 may be executed by executing a program by a processor included in the control unit 71 . That is, the control of the drug-solution administration device 10 may be realized by software. In this case, the program causes the computer to execute the processing of steps included in the operation of the drug-solution administration device 10, thereby causing the computer to implement the functions corresponding to the processing of the steps. Alternatively, part or all of the functions of the medicinal-solution administration device 10 may be implemented by a dedicated circuit included in the control section 71 . That is, part or all of the functions of the drug-solution administration device 10 may be realized by hardware. (Remote control configuration)
  • FIG. 6 is a block diagram showing an example of the hardware configuration of the remote control 90 of FIG. 1. As shown in FIG.
  • the remote controller 90 includes a control section 91 , a storage section 92 , a communication section 93 , an input section 94 , an output section 95 and a bus 99 .
  • the control unit 91 is one or more processors.
  • the control unit 91 is communicably connected to each constituent unit of the remote controller 90 via a bus 99 and controls the operation of the remote controller 90 as a whole.
  • the processor is a general-purpose processor such as a CPU or GPU (Graphics Processing Unit), or a dedicated processor specialized for specific processing.
  • Control unit 91 may include one or more dedicated circuits, or one or more processors may be replaced by one or more dedicated circuits in control unit 91 .
  • a dedicated circuit is, for example, an FPGA.
  • the storage unit 92 is one or more semiconductor memories, one or more magnetic memories, one or more optical memories, or a combination of at least two of them.
  • a semiconductor memory is, for example, a RAM or a ROM.
  • RAM is, for example, SRAM (Static RAM) or DRAM (Dynamic RAM).
  • the ROM is, for example, an EEPROM (Electrically Erasable Programmable ROM).
  • the storage unit 92 functions, for example, as a main storage device, an auxiliary storage device, or a cache memory.
  • the communication unit 93 is a communication interface for communicating with the drug-solution administration device 10.
  • the communication unit 93 communicates with the medicinal-solution administration device 10 to transmit information input by the user to the medicinal-solution administration device 10 and receive information from the medicinal-solution administration device 10 .
  • the communication unit 93 communicates with the medicinal-solution administration device 10 via, for example, Bluetooth (registered trademark), but is not limited to this, and may communicate via other wireless communication paths such as wireless LAN or wired cables, for example.
  • the input unit 94 includes one or more input interfaces that receive user's input operations and acquire input information based on the user's operations.
  • the input unit 94 is, for example, a touch screen provided integrally with the display (display device) of the output unit 95, but is not limited to this, physical keys (eg, external numeric keypad), capacitance keys, pointing It may be a device or a microphone or the like that receives voice input.
  • the output unit 95 as a display unit outputs information to the user and includes one or more output interfaces for notifying the user.
  • the output unit 95 is a display that outputs information by image display, an LED (Light Emitting Diode), a speaker, a vibrator, or the like, but is not limited to these.
  • the functions of the remote control 90 may be realized by executing the program according to the present embodiment with a processor included in the control unit 91. That is, the functions of the remote control 90 may be realized by software. In this case, the program causes the computer to execute the processing of steps included in the operation of the remote control 90, thereby causing the computer to implement the functions corresponding to the processing of the steps.
  • some or all of the functions of remote controller 90 may be realized by a dedicated circuit included in control section 91 . That is, some or all of the functions of remote control 90 may be realized by hardware.
  • the user adjusts the position of the plunger 20 with respect to the reservoir 18 and fills the reservoir 18 with an arbitrary amount of drug solution from the introduction port 26 from a drug solution container such as a vial in which the drug solution is hermetically stored.
  • the user connects the device main body 14 to the cartridge 12 (initial connection).
  • the power of the battery 42 of the cartridge 12 is supplied to the components of the device main body 14 , and the output gear 48 of the gear box 46 of the device main body 14 meshes with the spur gear 50 of the cartridge 12 .
  • the control unit 71, the storage unit 72, and the like are activated by being supplied with power from the battery 42.
  • the first priming is an operation performed on the drug solution administration device 10 immediately after the cartridge 12 taken out of the packaging container is filled with the drug solution and the cartridge 12 and the device main body 14 are connected. is engaged with the plunger 20 and the flow channel is filled with the chemical solution.
  • the remote controller 90 is operated to rotate the motor 44 forward.
  • the rotational driving force of the motor 44 is transmitted to the feed screw shaft 22 via the gear box 46, the spur gear 50, and the transmission shaft 52, so that the feed screw shaft 22 rotates, and the nut portion 24 moves toward the guide wall. While sliding 68, it advances to the plunger 20 side.
  • the pair of claw portions 38 hits the wall surface forming the through hole 64 of the nut portion 24, and the pair of extension portions 36 are bent so as to approach each other.
  • the extension portion 36 returns from the bent state to its original state, and the nut portion 24 is locked to the rear end portion of the plunger 20 .
  • the nut portion 24 can press the plunger 20 toward the distal end side.
  • the chemical solution in the reservoir 18 is pressed against the plunger 20, and the inner hole of the lead-out tube 29 is filled with the chemical solution, completing the first priming.
  • This first priming is completed when the user visually recognizes that the drug solution is discharged from the connecting needle tube that is fluidly connected to the outlet tube 29 and exposed to the outside of the drug solution administration device 10 .
  • the position where the nut portion 24 is locked with respect to the plunger 20 corresponds to the initial filling amount of the chemical solution.
  • the user attaches a cradle (not shown) to a predetermined position on the skin. Then, the user uses the puncture mechanism to leave the cannula in the living body through the opening of the cradle. Next, the user attaches the drug solution administration device 10, in which the cartridge 12 and the device main body 14 are connected, to the cradle, so that the connecting needle tube and the cannula communicate with each other.
  • the drug solution administration device 10 in which the cartridge 12 and the device main body 14 are connected, to the cradle, so that the connecting needle tube and the cannula communicate with each other.
  • the control unit 71 controls the rotation of the motor 44 in accordance with the drug solution administration schedule instructed from the remote controller 90, and administers the drug solution at various rates such as a basal rate or a bolus according to the patient's condition.
  • the basal rate is the amount of drug solution per unit time corresponding to basal secretion.
  • a bolus is the amount of drug solution that provides additional secretion in response to a meal or an increase in blood sugar level.
  • the drug solution filled in the reservoir 18 of the cartridge 12 is administered into the body over, for example, several days to one week, and the cartridge 12 is replaced after the administration period has passed.
  • the cartridge 12 is replaced, filling of the reservoir 18 of the cartridge 12 with the chemical solution, connection of the cartridge 12 and the apparatus main body 14, and first priming are performed.
  • the medicinal-solution administration device 10 uses the position where the nut part 24 is locked by the plunger 20 at the time of completion of the first priming as a reference.
  • the amount of the administered liquid medicine also referred to as an estimated dose amount
  • the remaining amount of the liquid medicine can be estimated.
  • the administration history of the medicinal-solution administration device 10 may be managed by the remote controller 90 from the viewpoint of preventing misuse of the medicinal-solution administration device 10 and mistaken administration history data.
  • the storage unit 72 of the device body 14 may be configured to be erased when the power supply is interrupted. As a result, the control unit 71 and the storage unit 72 of the device main body 14 can reduce the amount of data to be held without identifying a plurality of cartridges by individual IDs or the like, so that the cost of the drug-solution administration device 10 can be reduced. can be done.
  • the medical solution administration operation may be unintentionally interrupted.
  • the control unit 71, storage unit 72, etc. and the drug-solution administration device 10 stops operating.
  • the administration history stored in the storage unit 72 without being transmitted to the remote controller 90 is reset.
  • the initial filling amount information based on the position of the nut portion 24 at the time of completion of the first priming, the estimated amount of administration, or the residual amount of the liquid medicine can be obtained. Since the amount information and the like are lost, the medical-solution administration device 10 cannot accurately know the replacement timing of the cartridge 12 based on the remaining amount.
  • the plunger 20 may move when the user touches the plunger 20 while the cartridge 12 and the apparatus main body 14 are disconnected. However, there may be a case where the information does not match the information in the storage unit 72 or the like.
  • the medicinal-solution administration device in order to grasp the position of the plunger 20, the medicinal-solution administration device brings the nut portion 24 into contact with the bearing 56, which is the initial position, and then moves the nut portion 24 until the medicinal solution is discharged from the connecting needle tube. It is also possible to move in the ejection direction.
  • the drug-solution administration device may be set to the initial position when the slide portion 60 is moved to the end portion of the guide wall 68 .
  • a restricting portion may be provided at the end of the guide wall 68 so that the sliding portion 60 cannot move any further.
  • the medicinal-solution administration device can detect whether or not the nut portion 24 has reached the initial position based on whether or not the motor 44 has stepped out.
  • the medicinal-solution administration device 10 includes a position detection portion 74 that detects the position of the nut portion 24 on the side of the medicinal-solution discharge direction relative to the initial position of the nut portion 24 .
  • the medical-solution administration device 10 performs the second priming when the cartridge 12 and the device main body 14 are reconnected.
  • the second priming refers to an operation of detecting the position of the nut portion 24 of the drug solution administration device 10 immediately after the cartridge 12 and the device main body 14 are reconnected, and filling the channel with the drug solution.
  • the medical-solution administration device 10 causes the motor 44 to reversely rotate faster than usual until the position of the nut portion 24 can be detected by the position detection portion 74 to retract the nut portion 24 .
  • the drug-solution administration device 10 rotates the motor 44 forward faster than usual by the same number of rotations as the number of rotations of the reverse rotation to push the nut part 24 forward. , the nut portion 24 is advanced until the drug solution is discharged from the connecting needle tube. In this manner, when the cartridge 12 and the device main body 14 are reconnected, the drug-solution administration device 10 does not return the nut portion 24 to the initial position, but retreats until the position can be detected. advance until the medicinal solution is discharged from the connected needle tube. Therefore, according to the medicinal-solution administration device 10, it is possible to shorten the time required to restart the medicinal-solution administration.
  • FIGS. 7 to 10 are flowcharts showing the operation procedure of the medicinal-solution administration device 10 of FIG.
  • the operation of the medical-solution administration device 10 described with reference to FIGS. 7 to 10 can correspond to one control method of the medical-solution administration device 10.
  • FIG. 7 to 10 can be executed under the control of the control unit 71 of the drug-solution administration device 10 or the control unit 91 of the remote controller 90.
  • FIG. The following processing is executed in response to detection of connection again after the connection between the device main body 14 of the drug-solution administration device 10 and the cartridge 12 has been released.
  • the cartridge 12 is connected for the first time, the nut portion 24 is at the non-contact position, and the motor 44 is immediately out of step at the initial position due to the reverse rotation.
  • the control unit 71 of the medicinal-solution administration device 10 determines whether or not step-out due to the reverse rotation of the motor 44 occurs in a program that is activated when the device main body 14 and the cartridge 12 are connected and power is supplied from the battery 42 . , it is possible to determine whether the connection between the apparatus main body 14 and the cartridge 12 is the initial connection or the reconnection.
  • step S1 of FIG. 7 the control unit 91 of the remote controller 90 detects from the output unit 95 that the connection between the device main body 14 of the drug-solution administration device 10 and the cartridge 12 has been disconnected, and that the connection has been detected again. is notified to the user.
  • the control unit 91 may notify by displaying on the display that disconnection and reconnection between the apparatus main body 14 and the cartridge 12 have been detected.
  • the control unit 91 may notify that effect.
  • the control unit 71 of the medicinal-solution administration device 10 is connected via the communication unit 73 in a program that is activated when the device main body 14 and the cartridge 12 are connected and power is supplied from the battery 42. may be notified to the remote controller 90 . In that case, the medical-solution administration device 10 may determine whether the connection is reconnection of the device main body 14 and the cartridge 12 based on the user's selection via the input unit 94 .
  • step S2 the control unit 91 of the remote controller 90 notifies the user that maintenance processing will be executed.
  • the control unit 91 may display on the display of the output unit 95 that maintenance processing is to be performed.
  • the maintenance processing here refers to execution of the second priming accompanying reconnection of the cartridge 12 and the apparatus main body 14 .
  • step S3 the control unit 91 of the remote controller 90 notifies the user to place the medicinal-solution administration device 10 vertically after removing it from the cradle.
  • a cradle detection switch may be provided in the medical-solution administration device 10 to determine disconnection from the cradle.
  • the control unit 91 may display on the display of the output unit 95 an image prompting the user to hold the medical-solution administration device 10 so that the outlet port 28 is positioned vertically above the reservoir 18 .
  • step S4 may be suspended until the posture of is appropriate.
  • step S4 the control unit 91 of the remote controller 90 notifies the user to select the start button.
  • the control unit 91 may display an image prompting selection of the start button of the input unit 94 on the display of the output unit 95 .
  • the input unit 94 is a touch screen provided integrally with the display of the output unit 95
  • the control unit 91 displays an image of the start button on the display of the output unit 95, and displays an image prompting the selection.
  • step S5 the control unit 91 of the remote controller 90 determines whether or not the start button has been selected by the user. If the start button is selected (YES in step S5), the control unit 91 proceeds to step S11 in FIG. 8, otherwise (NO in step S5), it waits until the start button is selected.
  • the control unit 71 of the medicinal-solution administration device 10 rotates the motor 44 in the reverse direction. That is, the control section 71 rotates the motor 44 so as to move the nut section 24 in the direction opposite to the discharge direction of the chemical solution. Reverse rotation of the motor 44 draws air into the reservoir 18 from the connecting needle. The rotation speed of this reverse rotation may be greater than the normal rotation speed when administering the drug solution. As a result, it is possible to restart administration of the liquid medicine in a short time.
  • the control unit 71 may perform the process of step S11 in response to receiving the notification that the start button has been selected from the communication unit 93 of the remote controller 90 by the communication unit 73 of the drug-solution administration device 10 .
  • step S12 the control unit 71 of the medicinal-solution administration device 10 determines whether or not the motor 44 is out of step, or contact between the slide unit 60 and any of the contact sensors 74a to 74d is detected. If the control unit 71 detects the step-out of the motor 44 or the contact of the slide unit 60 (YES in step S12), the process proceeds to step S13. Continue reverse rotation. Detection of step-out of the motor 44 means that the nut portion 24 has reached the initial position.
  • step S ⁇ b>13 the control unit 71 of the medicinal-solution administration device 10 stops the reverse rotation of the motor 44 .
  • step S14 the control unit 71 of the medicinal-solution administration device 10 acquires the number of revolutions M of the motor 44 from the start of the reverse rotation of the motor 44 in step S11 to the stop of the reverse rotation of the motor 44 in step S13.
  • the control unit 71 notifies the remote controller 90 of the obtained number of rotations M and the position at which the step-out of the motor 44 or the contact of the slide unit 60 is detected. Then, the controller 71 proceeds to step S21 in FIG.
  • step S21 the control unit 71 of the medicinal-solution administration device 10 determines whether or not the medicinal-solution administration device 10 faces a predetermined direction. That is, the control unit 71 determines whether or not the medical-solution administration device 10 is maintained in the direction in which the lead-out port 28 is positioned vertically above the reservoir 18 based on the posture of the medical-solution administration device 10 detected by the posture detection unit 75 . do. This determination is made to prevent the liquid medicine from being discharged from the connecting needle before the air due to the forward rotation of the motor 44 when the posture of the liquid medicine administration device 10 is not maintained. If the control unit 71 determines that the medicinal-solution administration device 10 faces the predetermined direction (YES in step S21), the process proceeds to step S22; otherwise (NO in step S21), the process proceeds to step S25.
  • step S22 the control unit 71 of the medicinal-solution administration device 10 causes the motor 44 to rotate forward.
  • the rotational speed of the motor 44 may be, for example, higher than the normal rotational speed when administering the liquid medicine, similar to the reverse rotation of the motor 44 in step S11 of FIG.
  • the forward rotation speed in step S22 may be the same as the reverse rotation speed in step S11.
  • step S23 the control unit 71 of the medicinal-solution administration device 10 determines whether or not the number of forward rotations of the motor 44 in step S22 is M. If the forward rotation number is M (YES in step S23), the control unit 71 proceeds to step S24, otherwise (NO in step S23), proceeds to step S21.
  • step S24 the control unit 71 of the medicinal-solution administration device 10 stops forward rotation of the motor 44. Then, the controller 71 proceeds to step S31 in FIG.
  • step S25 if the motor 44 is rotating, the control unit 71 of the medicinal-solution administration device 10 stops the rotation. That is, after starting forward rotation of the motor 44 in step S22, before the number of revolutions reaches M, if the posture of the drug-solution administration device 10 deviates from the predetermined direction, the control unit 71 stops the rotation of the motor 44. At the same time, the remote controller 90 is notified to that effect.
  • step S26 the control unit 91 of the remote controller 90 notifies the user to turn the drug-solution administration device 10 vertically.
  • the control unit 91 may display on the display of the output unit 95 an image prompting the user to hold the medical-solution administration device 10 so that the lead-out port 28 is positioned vertically above the reservoir 18, as in step S3. good.
  • the control unit 91 may make such notification in response to receiving from the medicinal-solution administration device 10 a notification that the posture of the medicinal-solution administration device 10 has deviated from the predetermined direction.
  • the process returns to step S21, and the control unit 71 of the medicinal-solution administration device 10 confirms the attitude of the medicinal-solution administration device 10.
  • step S31 of FIG. 10 the control unit 91 of the remote controller 90 notifies the user to select the liquid feed button and confirm the discharge of the liquid medicine.
  • This ejection of the chemical liquid fills the flow path of the chemical liquid administration device 10 in the second priming with the chemical liquid.
  • the control section 91 may display on the display of the output section 95 an image prompting the user to select the liquid feeding button of the input section 94 .
  • the input unit 94 is a touch screen provided integrally with the display of the output unit 95
  • the control unit 91 displays an image of the liquid feeding button on the display of the output unit 95, and displays an image prompting selection thereof. You may The control unit 91 may prompt the user to discharge the liquid medicine in response to receiving the notification that the motor 44 has been stopped from the liquid medicine administration device 10 in step S24.
  • step S32 the control unit 71 of the medicinal-solution administration device 10 rotates the motor 44 forward by a constant number of rotations N each time the liquid feeding button is selected on the remote controller 90, thereby discharging the medicinal solution in the reservoir 18 into the lead-out tube 29. Move to inner hole.
  • the control unit 71 may rotate the motor 44 in the forward direction at a slower speed than the forward rotation in step S22 of FIG.
  • the control unit 91 of the remote controller 90 displays an image (for example, a confirmation button) for notifying the liquid medicine administration device 10 of this on the display of the output unit 95. good too.
  • step S33 the control unit 91 of the remote controller 90 determines whether or not the user has notified from the input unit 94 that the discharge of the liquid medicine has been confirmed. If the confirmation of liquid medicine discharge has been notified (YES in step S33), the controller 91 proceeds to step S34; otherwise (NO in step S33), it returns to step S31.
  • step S34 the control unit 91 of the remote controller 90 selects a reservoir from the total number of normal rotations of the motor 44 and the initial position or the position of any one of the contact sensors 74a to 74d where the contact of the nut portion 24 or the slide portion 60 is detected. Estimate the remaining amount (filling amount) of the chemical solution in 18 .
  • the total number of forward rotations of the motor 44 is the total number of rotations of the motor 44 since the forward rotation of the motor was started in step S22. That is, the total number of forward rotations of the motor 44 is obtained by combining M obtained in step S14 of FIG. is the sum (M+N ⁇ number of selections) with the value multiplied by .
  • the movement distance L of the nut portion 24 caused by one rotation of the motor 44 may be stored in advance in the memory portion 92 (or the memory portion 72). In that case, the controller 91 may obtain the moving distance of the nut part 24 by L ⁇ (M+N ⁇ the number of selections).
  • the initial position of the nut portion 24 or the position of the nut portion 24 corresponding to the contact positions of the contact sensors 74a to 74d may also be stored in advance in the storage portion 92 (or the storage portion 72).
  • the initial positions or the positions of the contact sensors 74a to 74d are set so as to correspond to a predetermined amount of chemical solution.
  • control unit 91 corresponds to (1) the initial position reached by the nut portion 24 or the contact sensor 74 first after the reverse rotation is started, and (2) the initial position reached by the nut portion 24 or the contact sensor 74. (3) the total number of positive rotations of the motor 44 (M + N ⁇ number of selections) or the movement distance L of the nut portion 24 at the completion of the second priming; and (4) per rotation of the motor 44 or Based on at least one of the discharge amount of the chemical solution per unit movement distance of the nut portion 24, the remaining amount of the chemical solution can be estimated and obtained.
  • control unit 91 multiplies the total positive number of rotations of the motor 44 by the discharge amount of the chemical liquid per one rotation of the motor 44, at the initial position of the nut part 24 or the position of the plunger 20 when the contact sensor 74 reaches.
  • the residual amount of the chemical solution may be estimated by subtracting it from the amount of the chemical solution that can be filled in the reservoir 18 .
  • control unit 91 obtains the position of the nut portion 24 by subtracting the movement distance L of the nut portion 24 from the initial position reached by the nut portion 24 or the position of the contact sensor 74, and calculates the remaining amount of the chemical solution in the reservoir 18. can be estimated.
  • the correspondence relationship between the position of the nut portion 24 and the remaining amount of the chemical solution is stored in advance in the storage unit 92 (or the storage unit 72), and the control unit 91 refers to the correspondence relationship to determine the remaining amount of the chemical solution. can be estimated.
  • step S35 the control unit 91 of the remote controller 90 displays the residual amount (filling amount) of the chemical liquid estimated in step S34 on the display of the output unit 95. Then, the control unit 91 ends the processing of the flowchart.
  • the drug solution administration device 10 that administers the drug solution filled in the reservoir 18 into the living body by the pressing action of the plunger 20 includes the reservoir 18, the plunger 20, the nut portion 24, the drive portion 40, the position detection portion 74, and the A control unit 71 is provided.
  • the reservoir 18 is filled with the chemical solution.
  • a plunger 20 is provided within the reservoir 18 and is movable in the longitudinal direction of the reservoir 18 .
  • the nut portion 24 can press the plunger 20 toward the distal end of the reservoir 18 by moving in the movable region.
  • the driving part 40 moves the nut part 24 in the movable area.
  • the position detection portion 74 can detect the nut portion 24 at a predetermined detection position in the movable area.
  • control unit 71 moves the nut part 24 in the direction opposite to the distal end side until the position detection part 74 detects the nut part 24 at the detection position. move.
  • the control unit 71 estimates the remaining amount of the liquid medicine in the reservoir 18 based on the first movement amount, which is the amount of movement in the opposite direction, and operates the driving unit 40 so as to restart administration of the liquid medicine based on the remaining amount. Control.
  • the nut portion 24 is moved in the direction opposite to the distal end side until the position detection portion 74 detects the nut portion 24 instead of the initial position. , the remaining amount of the chemical solution is estimated based on the amount of movement, and the administration of the chemical solution is resumed. Therefore, according to the medical-solution administration device 10 according to the present embodiment, it is possible to shorten the time required to resume the administration of the medical-solution when the administration of the medical-solution is interrupted.
  • the second priming can be performed by the position detection unit 74 provided at a position closer to the outlet port 28 than when performing the second priming at the initial position. Therefore, the time and power consumption required for the second priming can be greatly reduced.
  • the amount of movement of the nut portion 24 is indicated by, for example, the number of rotations of the motor 44, but may be indicated by any unit representing the magnitude of movement of the nut portion 24, such as the distance of movement of the nut portion 24.
  • the drug-solution administration device 10 may move the nut portion 24 at a faster speed than the movement speed of the nut portion 24 during the drug-solution administration operation.
  • the medicinal-solution administration device 10 can further shorten the time required to restart medicinal-solution administration.
  • control section 71 may move the nut section 24 from the detection position toward the distal end by the first movement amount. After that movement, the control unit 71 moves the nut part 24 by the second movement amount to the distal end side until the flow path in the medical-solution administration device 10 is filled with the medical solution, and then restarts the medical-solution administration.
  • the drive unit 40 may be controlled. In this manner, the medicinal-solution administration device 10 moves the nut part 24 toward the distal end by the first amount of movement, which is the amount of movement in the opposite direction when the medicinal-solution administration is interrupted, and then the flow path is filled with the medicinal solution. The nut portion 24 is moved distally until it is filled.
  • the medical-solution administration device 10 moves the nut portion 24 to a position suitable for the second priming, the medical-solution administration can be restarted in a short time.
  • the medicinal-solution administration device 10 moves the nut portion 24 at a faster speed than the movement speed of the nut portion 24 during the medicinal-solution administration operation. good too.
  • the medicinal-solution administration device 10 can further shorten the time required to restart medicinal-solution administration.
  • the driving section 40 may move the nut section 24 by transmitting driving force based on the rotation of the motor 44 .
  • the control unit 71 controls the detection position, the number of rotations of the motor 44 necessary for moving the nut portion 24 by the first amount of movement, and the number of revolutions of the motor 44 necessary for moving the nut portion 24 by the second amount of movement. and the remaining amount of the chemical solution may be estimated. Therefore, the medicinal-solution administration device 10 can estimate the remaining amount of the medicinal solution with high accuracy.
  • the medicinal-solution administration device 10 may include a plurality of position detection units 74a to 74d capable of detecting the nut portion 24 at different detection positions in the movable region of the nut portion 24.
  • the control unit 71 moves the nut portion 24 toward the distal end side until any one of the plurality of position detection units 74a to 74d detects the nut portion 24 in response to being able to resume the interrupted drug solution administration. can be moved in the opposite direction.
  • the medicinal-solution administration device 10 moves the nut portion 24 in the direction opposite to the tip (outlet port 28) side until any one of the plurality of position detection portions 74a to 74d detects. , it is possible to further shorten the time required to restart administration of the liquid medicine.
  • the medical-solution administration device 10 includes four position detectors 74a to 74d, but the number of position detectors 74 is arbitrary. When a plurality of position detectors 74 are provided, the intervals between adjacent position detectors 74 may be the same or different.
  • the medical-solution administration device 10 does not include a plurality of devices capable of detecting the nut portion 24 at a specific position as the position detection portion 74, but can detect the nut portion 24 at any position in the movable region of the nut portion 24. device may be provided.
  • the drug-solution administration device 10 may include a disposable cartridge 12 and a reusable device body 14 detachably attached to the cartridge 12 .
  • the reservoir 18, plunger 20, nut portion 24, drive portion 40, position detection portion 74, and control portion 71 may be provided in the cartridge 12 or the device main body 14, respectively.
  • the control unit 71 moves the nut portion 24 forward until the position detection unit 74 detects the nut portion 24 at the detection position. You may move it in the direction opposite to the side.
  • the control unit 71 may estimate the amount of liquid medicine remaining in the reservoir 18 based on the first movement amount, and control the driving unit 40 to restart administration of the liquid medicine based on the remaining amount.
  • the liquid medicine administration device 10 When the liquid medicine administration device 10 is composed of the cartridge 12 and the device main body 14 in this way, there is a possibility that the cartridge 12 and the device main body 14 are disconnected due to contact with an object during liquid medicine administration.
  • the medicinal-solution administration device 10 starts an operation for resuming medicinal-solution administration when the cartridge 12 and the device main body 14 are connected. It is possible to restart quickly. 3 and 4, the reservoir 18, the plunger 20, the nut portion 24, and the battery 42 are provided in the cartridge 12, and the drive portion 40, the position detection portion 74, and the control portion 71 are provided in the device main body 14. However, it is not limited to such a configuration.
  • the drug-solution administration device 10 may be made reusable, for example, with all components. good.
  • the medicinal solution administration device 10 may display the estimated remaining amount of medicinal solution on the display device. Therefore, the user can grasp the remaining amount of the liquid medicine by referring to the display device.
  • the medicinal-solution administration device 10 displays the remaining amount on the display of the output unit 95 of the remote controller 90.
  • the medicinal-solution administration device 10 itself has a display device, the remaining amount is displayed on the display device.
  • the medicinal-solution administration device 10 may notify and display the remaining amount of the medicinal solution on another device such as a smart phone, a smart watch, or a tablet, for example.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un dispositif d'administration de médicament liquide 10 comprend : un réservoir 18 rempli d'un médicament liquide; un piston 20 qui est disposé à l'intérieur du réservoir 18 et peut se déplacer dans la direction longitudinale du réservoir 18; une partie écrou 24 qui peut presser le piston 20 vers le côté extrémité de pointe du réservoir 18 en se déplaçant à l'intérieur d'une région de déplacement; une unité d'entraînement 40 qui entraîne la partie écrou 24 de façon à ce qu'elle se déplace à l'intérieur de la région de déplacement; une unité de détection de position 74 qui détecte la partie écrou 24 dans une position de détection prédéfinie dans la région de déplacement; et une unité de commande 71. L'unité de commande 71 commande l'unité d'entraînement 40 de façon à ce que la partie écrou 24 soit déplacée dans la direction opposée au côté extrémité de pointe jusqu'à ce que l'unité de détection de position 74 détecte la partie écrou 24 dans la position de détection, et de telle sorte que la quantité restante de médicament liquide dans le réservoir 18 soit estimée sur la base d'une première valeur de déplacement, qui correspond à la valeur de déplacement dans la direction opposée.
PCT/JP2022/034106 2022-01-07 2022-09-12 Dispositif d'administration de médicament liquide, son procédé de commande et système d'administration de médicament liquide WO2023132104A1 (fr)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009526565A (ja) * 2006-02-14 2009-07-23 バテル メモリアル インスティチュート 正確な計測システム
WO2016132937A1 (fr) * 2015-02-20 2016-08-25 テルモ株式会社 Dispositif d'administration de médicament liquide
JP2016527938A (ja) * 2013-06-28 2016-09-15 アニマス・コーポレイション 安全保護装置を備える薬物注入装置
JP2019506228A (ja) * 2016-02-26 2019-03-07 イーライ リリー アンド カンパニー 残留薬剤判定能力を有する再使用可能な薬剤送達装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009526565A (ja) * 2006-02-14 2009-07-23 バテル メモリアル インスティチュート 正確な計測システム
JP2016527938A (ja) * 2013-06-28 2016-09-15 アニマス・コーポレイション 安全保護装置を備える薬物注入装置
WO2016132937A1 (fr) * 2015-02-20 2016-08-25 テルモ株式会社 Dispositif d'administration de médicament liquide
JP2019506228A (ja) * 2016-02-26 2019-03-07 イーライ リリー アンド カンパニー 残留薬剤判定能力を有する再使用可能な薬剤送達装置

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