WO2023132103A1 - Dispositif d'administration de solution médicamenteuse, son procédé de commande et système d'administration de solution médicamenteuse - Google Patents

Dispositif d'administration de solution médicamenteuse, son procédé de commande et système d'administration de solution médicamenteuse Download PDF

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Publication number
WO2023132103A1
WO2023132103A1 PCT/JP2022/034105 JP2022034105W WO2023132103A1 WO 2023132103 A1 WO2023132103 A1 WO 2023132103A1 JP 2022034105 W JP2022034105 W JP 2022034105W WO 2023132103 A1 WO2023132103 A1 WO 2023132103A1
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WIPO (PCT)
Prior art keywords
reservoir
administration device
control unit
drug
solution administration
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Application number
PCT/JP2022/034105
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English (en)
Japanese (ja)
Inventor
祐介 薬師寺
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023132103A1 publication Critical patent/WO2023132103A1/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

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 therapeutic drug injection device that transmits an indication of the current battery level to a handset (paragraph [0017]).
  • the drug solution administration device consists of a disposable cartridge (disposable part) having a structure to be filled with a drug solution and a reusable device main body (reusable part), and is driven by the power of a battery provided in the device main body. It is conceivable to let In the conventional medical-solution administration device, there is room for improvement in the measurement accuracy of the number of times the cartridge can be replaced and operated without charging the battery.
  • 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 measuring with higher accuracy than the number of times the cartridge can be replaced.
  • 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, and is provided in a disposable cartridge that is detachably connected.
  • a reservoir filled with the chemical a flow path connected to the reservoir and leading the chemical to the outside of the reservoir, and the plunger movable in the longitudinal direction of the reservoir, and moving in a movable region.
  • a movable portion capable of pressing the plunger toward the tip of the reservoir, a driving portion moving the movable portion within the movable region, and a battery supplying electric power for driving the driving portion.
  • a priming power amount which is the amount of power required to move the movable part until the flow path of the medical-solution administration device is filled with the medical solution
  • a charging power to the reservoir a priming power amount
  • the number of exchangeable times which is the number of times the cartridge can be exchanged, based on the amount of electric power required for administering the liquid medicine and the amount of electric power remaining in the battery. is calculated, and the calculated number of possible exchanges is presented to the user.
  • the driving section moves the movable section by transmitting a driving force based on the rotation of a motor
  • the control section controls the flow path of the medical-solution administration device until the liquid medicine is filled with the liquid medicine.
  • the priming power amount and the liquid feeding power amount are estimated based on the number of rotations of the motor that is rotated to move the movable portion.
  • control unit calculates the number of exchangeable times by dividing the amount of power remaining in the battery by the total value of the priming power amount and the liquid feeding power amount.
  • control unit causes the display device to display the calculated number of possible exchanges.
  • 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 medical-solution administration device includes: a reservoir filled with a medical solution provided in a detachably connected disposable cartridge; a plunger movable in the longitudinal direction of the reservoir; a movable portion capable of pressing the plunger toward the distal end side of the reservoir by moving in the movable region; a driving unit for moving the unit in the movable area, a battery for supplying electric power for driving the driving unit, and a control unit, and the chemical liquid filled in the reservoir is generated by the pressing action of the plunger.
  • a control method for a liquid medicine administration device for administering into the body comprising: a priming power amount that is the amount of power required for the control unit to move the movable part until the flow path is filled with the liquid medicine; Replacement, which is the number of times that the cartridge can be replaced based on the amount of power required to administer the drug solution filled in the cartridge and the amount of power remaining in the battery. calculating a possible number of times; and presenting the calculated possible number of exchanges to a user.
  • FIG. 4 is a diagram showing an example of an exploded perspective view of the pump body of FIG. 3;
  • 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. 4 is a diagram showing an example of an exploded perspective view of the pump body of FIG. 3;
  • 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. 1;
  • FIG. 10 is a flow chart showing the procedure of the rotational speed measurement process of FIG. 9;
  • 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 1 and a remote controller 90 .
  • the drug solution administration device 1 is a device that continuously or intermittently administers a drug solution filled in a reservoir (syringe) 18 into a living body by the pressing action of a plunger 20, as will be described later with reference to FIG.
  • the drug-solution administration device 1 may be, for example, a portable device that can be attached to the patient's abdomen (patch type).
  • the drug-solution administration device 1 is not limited to a patch type, and may be a tube type or the like.
  • a remote controller 90 is a device for a user such as a patient to operate the drug-solution administration device 1 .
  • the remote controller 90 notifies the user of information received from the medical-solution administration device 1 and accepts user's operations on the medical-solution administration device 1 .
  • the remote control 90 is realized by a dedicated device compatible with the drug-solution administration device 1, but may be realized 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 function may be provided in the drug-solution administration device 1 .
  • the medicinal-solution administration device 1 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 a perspective view of the medicinal-solution administration device 1 of FIG.
  • FIG. 3 is a diagram showing an example of a perspective view when the medicinal-solution administration device 1 of FIG. 1 is separated.
  • the drug-solution administration device 1 has a pump body 10 , a cradle device 11 to which the pump body 10 is detachably attached, and a connection port 106 attached to the cradle device 11 .
  • the pump body 10 and the cradle device 11 have a structure that can be repeatedly attached and detached by being engaged with each other.
  • the pump main body 10 includes a housing 111 that accommodates each component of the drug-solution administration device 1 such as the reservoir 18 and the plunger 20 .
  • the housing 111 may be formed in a flat, substantially rectangular parallelepiped shape with curved corners.
  • the upper surface portion 121 of the housing 111 is one surface of the pump body 10 located opposite to the side on which the cradle device 11 is mounted.
  • the upper surface portion 121 may be formed in a substantially rectangular shape with curved corners when viewed from above.
  • a front surface portion 123 and a rear surface portion 124 facing each other are substantially perpendicularly continuous to the end portion of the upper surface portion 121 in the first direction.
  • a side surface portion 126 continues substantially perpendicularly to the end portion of the upper surface portion 121 in the second direction.
  • the pump main body 10 may have an engaging structure in which the pump main body 10 and the cradle device 11 can be repeatedly attached and detached at the side portion 126 .
  • the engagement structure may have, for example, a hook mechanism. Specifically, a guide groove portion 137 and an engaging hook portion 138 may be formed on the side portion 126 .
  • the engaging hook portion 138 may be formed closer to the back surface portion 124 than the guide groove portion 137 .
  • the engagement hook portion 138 may be detachably engaged with an engagement receiving portion 162 of the cradle device 11, which will be described later.
  • the cradle device 11 is configured to be able to carry the pump body 10 . As shown in FIGS. 2 and 3, the cradle device 11 has a substantially flat mounting surface portion 141 and side wall portions 143 and 144 .
  • the mounting surface portion 141 is formed in a substantially rectangular shape with curved corners when viewed from above.
  • a detection rail 152 , a sliding rail 153 and a mounting portion 155 may be provided on one surface of the mounting surface portion 141 .
  • the connection port 106 may be attached to the attachment portion 155 .
  • the mounting portion 155 may be provided with an insertion hole through which the cannula of the connection port 106 is inserted.
  • the detection rail 152 is a ridge protruding from one surface of the mounting surface 141 .
  • the detection rail 152 is used by the pump body 10 to detect attachment of the cradle device 11 .
  • the detection rail 152 gradually increases in thickness from the mounting surface portion 141 toward the side wall portion 144 side.
  • the detection rail 152 extends for a predetermined length parallel to the side wall portion 143 .
  • the slide rail 153 extends parallel to the side wall portion 143 on one surface of the mounting surface portion 141 .
  • a slide groove (not shown) provided on the bottom surface of the pump body 10 is slidably fitted into the slide rail 153 .
  • a side wall portion 144 continues substantially perpendicularly to the end portion of the mounting surface portion 141 in the first direction.
  • Side wall portions 143 facing each other are substantially perpendicular to the end portions of the mounting surface portion 141 in the second direction.
  • the side wall portion 143 faces the side portion 126 of the housing 111 of the pump main body 10 .
  • the side wall portion 144 faces the front portion 123 of the housing 111 .
  • the side wall 144 of the cradle device 11 may have a fitting hole 154 that is an opening.
  • a fitting projection provided on the front portion 123 of the pump body 10 may be fitted into the fitting hole 154 .
  • the side wall portion 143 may be formed with a guide rail 151, a posture correction portion 156, and an engagement receiving portion 162.
  • the engagement receiving portion 162 may be an opening formed by cutting the side wall portion 143 into a substantially rectangular shape.
  • the engagement hook portion 138 may be detachably engaged with the engagement receiving portion 162 when the pump body 10 is attached to the cradle device 11 .
  • the guide rail 151 is a ridge formed on the side wall 143 .
  • the guide rail 151 does not necessarily have to extend continuously.
  • a notch 158 may be appropriately provided in the middle of the guide rail 151 .
  • the posture corrector 156 is a plate-shaped projection extending upward from the side wall 143. As shown in FIG. Posture correcting portion 156 may have a curved shape corresponding to the shape of the connecting portion (corner portion) between upper surface portion 121 and side surface portion 126 of housing 111 of pump body 10 .
  • the cradle device 11 may be provided with an adhesive sheet that is attached to the patient's skin.
  • the adhesive sheet may be attached to the other surface of the mounting surface portion 141 of the cradle device 11 opposite to the one surface.
  • the adhesive sheet may be formed with an opening (not shown) through which a cannula of the connection port 106 (to be described later) passes.
  • the patch sheet may be formed of a flexible member.
  • An adhesive layer that is attached to the patient's skin may be formed on the surface opposite to the mounting surface portion 141 of the patch sheet.
  • the adhesive layer of the patch sheet may be covered with a release paper before being attached to the patient's skin.
  • the connection port 106 may have a port body 181 capable of holding a cannula therein.
  • the port body 181 may have a tubular connecting portion. When the cannula is connected, the interior of the connection (bore), the port body 181, and the cannula communicate.
  • a cap 182 is attached to the tip of the connecting portion, and the other end of the connecting portion is connected to a port body 181 .
  • a cap 182 seals the distal end opening of the connecting portion. This isolates the inside of the connection port 106 from the external environment.
  • connection port 106 When the connection port 106 is attached to the attachment portion 155 of the cradle device 11 using a puncture mechanism (not shown), the cannula penetrates the mounting surface portion 141 together with the puncture needle, and the other surface of the mounting surface portion 141 (which is attached to the skin) surface). The cannula is then punctured into the living body together with the puncture needle. After that, the cannula is left in the living body by removing the puncture needle.
  • the connecting portion of the port body 181 may face the upstream side in the mounting direction.
  • a connecting needle tube exposed to the outside of the pump body 10 is fluidly connected to the lead-out tube 29 .
  • the connecting needle tube penetrates into the cylindrical hole.
  • the port body 181 and the outlet tube 29 (see FIG. 5, etc.) of the pump body 10 are connected, and the outlet tube 29 and the cannula are fluidly connected.
  • the drug solution stored in the reservoir 18 of the pump body 10 is delivered to the connection port 106 through the lead-out tube 29 and administered to the patient through the cannula by driving the drive unit 40 (see FIG. 5, etc.). be.
  • the lead-out tube 29 is connected to the reservoir 18 and acts as a channel for leading the drug solution out of the reservoir 18 .
  • the connecting needle tube is connected to the lead-out tube 29, the flow path of the drug-solution administration device 1 may include the lead-out tube 29 and the connecting needle tube.
  • FIG. 4 is a diagram showing an example of an exploded perspective view of the pump body 10 of FIG.
  • FIG. 5 shows an example of the cartridge 12 with the nut portion 24 at the non-contact position.
  • FIG. 6 shows an example of the cartridge 12 with the nut portion 24 at a predetermined position.
  • the pump body 10 includes a disposable cartridge 12 and a reusable device 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 provided detachably with respect to the cradle device 11 that can be adhered to the patient's skin.
  • 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 provided coaxially with the plunger 20, and a feed screw shaft.
  • a nut portion (movable portion) 24 that is screwed onto 22 is provided.
  • 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 outlet port 28 (see FIG. 5) 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 molded with 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 sealing member 34 slidable in the reservoir 18 is attached to the cylindrical rear end of the plunger body 30 .
  • 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 transmission shaft 52 is provided in the cartridge 12, and the battery 42, the motor 44, and the gear box 46 are provided in the apparatus main body 14.
  • the battery 42 may be a secondary battery.
  • the battery 42 is provided with terminals 54 electrically connected to the motor 44 .
  • 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 when a certain force (torque) is applied to the forward or reverse rotation, the rotational driving force is not transmitted to the components below the gear box 46 .
  • a stepping motor for example, may be employed as the motor 44 .
  • a stepping motor when a certain amount of force is applied to forward or reverse rotation, the motor 44 will not be synchronized with the input pulse and will not transmit rotational driving force (step out). For example, if the motor 44 rotates in the opposite direction while the nut portion 24 is in contact with the rearmost end of the feed screw shaft 22 on the bearing 56 side, the motor 44, gear box 46, transmission shaft 52, and other mechanisms may malfunction due to step-out. It is possible to prevent damage due to excessive force.
  • a rotary encoder (not shown) is provided on the output shaft of the motor 44, and whether or not the motor 44 is out of synchronization with the input pulse (step out) can be determined 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 .
  • 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, before use, the nut portion 24 is in a non-contact position (see FIG. 5), and the nut portion 24 and the plunger 20 are moved from the non-contact position by the rotation of the feed screw shaft 22. It moves to the locked contact position (hereinafter referred to as "initial position"). After contacting the plunger 20, further rotation of the feed screw shaft 22 causes the nut portion 24 to press the plunger 20 to the distal end side (see FIG. 6).
  • the guide wall 68 may be provided with a regulating portion that serves as a stopper so that the slide portion 60 cannot retreat any further.
  • the device main body 14 includes a cover body 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, and a A communication unit 73 is provided.
  • the lid may be provided on the upper surface portion 121 of the housing 111 .
  • a battery 42, a motor 44, a storage unit 72, and a communication unit 73 are electrically connected to the control unit 71 via a bus 79 (see FIG. 7).
  • the control unit 71 controls each part of the medicinal-solution administration device 1 and executes processing related to the operation of the medicinal-solution administration device 1 . For example, the control unit 71 drives and controls the motor 44 based on information regarding drug solution administration transmitted from the remote controller 90 .
  • FIG. 7 is a block diagram showing an example of a configuration related to control of the medicinal-solution administration device 1 of FIG.
  • the battery 42 , the motor 44 , the storage unit 72 , and the communication unit 73 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 medicinal-solution administration device 1 and controls the operation of the medicinal-solution administration device 1 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 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
  • Control of the medicinal-solution administration device 1 may be executed by executing a program by a processor included in the control unit 71 . That is, the control of the medicinal-solution administration device 1 may be realized by software.
  • the program causes the computer to execute the processing of steps included in the operation of the drug-solution administration device 1, thereby causing the computer to implement the functions corresponding to the processing of the steps.
  • part or all of the functions of the medicinal-solution administration device 1 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 1 may be realized by hardware.
  • FIG. 8 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 1.
  • the communication unit 93 communicates with the medicinal-solution administration device 1 to transmit information input by the user to the medicinal-solution administration device 1 and receive information from the medicinal-solution administration device 1 .
  • the communication unit 93 communicates with the medicinal-solution administration device 1 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 fills the reservoir 18 with an appropriate amount of medicinal solution from a medicinal solution container such as a vial in which the medicinal solution is hermetically stored using a filling device, syringe, or the like.
  • a medicinal solution container such as a vial in which the medicinal solution is hermetically stored using a filling device, syringe, or the like.
  • the plunger 20 is moved to a position corresponding to the initial filling amount.
  • the user mounts the device main body 14 on the cartridge 12 .
  • the power of the battery 42 of the device main body 14 is supplied to each component, 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 user primes the medical-solution administration device 1.
  • Priming refers to an operation of filling the flow path of the drug-solution administration device 1, including the lead-out tube 29, the cannula, etc., with the drug 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 claw portion 38 passes through the through hole 64 , the claw portion 38 returns to its original position, thereby locking the nut portion 24 with respect to the plunger 20 .
  • the nut portion 24 can be pushed forward while holding the plunger 20 .
  • the chemical in the reservoir 18 is pressed by the plunger 20, and the inner hole of the lead-out tube 29 as a flow path is filled with the chemical, completing priming.
  • the user observes the tip of the connecting needle tube that continues to the outlet tube 29, confirms that the drug solution has flowed out from the tip of the connecting needle tube, and instructs the drug-solution administration device 1 to stop priming.
  • the remote controller 90 may display an image of a priming stop button on the display of the output unit 95 and notify the medical-solution administration device 1 to stop the motor 44 in response to the user selecting the priming stop button.
  • the user attaches the cradle device 11 to a predetermined position on the skin, uses the puncture mechanism to leave the cannula of the connection port 106 in the living body, and locks the connection port 106 to the cradle device 11 .
  • the lead-out tube 29 and the cannula are communicated, and the control unit 71 controls the rotation of the motor 44, whereby the drug solution in the reservoir 18 is continuously or continuously delivered to the living body. It will be administered intermittently.
  • 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 bolus according to the patient's condition.
  • the basal rate is the amount of drug solution per unit time corresponding to the basal secretion of insulin.
  • a bolus is an amount of drug solution corresponding to additional secretion of insulin in response to a meal or an increase in blood sugar level.
  • the reservoir 18 of the cartridge 12 is filled with the amount of drug solution to be administered in an administration cycle of a certain number of days. After the drug solution filled in the reservoir 18 is administered into the body over, for example, three days to one week, the cartridge 12 is replaced and discarded. The cartridge 12 is replaced with a new cartridge for each administration cycle. Each time the cartridge 12 is replaced, the chemical filling of the reservoir 18 of the cartridge 12, the connection between the cartridge 12 and the apparatus main body 14, and the priming operation are performed. Through such an operation, the medical-solution administration device 1 can estimate the amount of medical-solution to be administered, for example, based on the number of rotations of the motor 44 during priming and liquid-feeding. Since the drug-solution administration device 1 according to this embodiment includes the disposable cartridge 12 and the reusable device main body 14, it is possible to reduce the running cost.
  • the amount of drug solution filled in the reservoir 18 of the cartridge 12 varies depending on the patient's age and condition, etc., even if the length of the administration cycle is the same. For example, if the reservoir 18 is filled with three days' worth of liquid medicine, the cartridge 12 for adults will be filled with more liquid than the cartridge 12 for children.
  • the medical-solution administration device 1 moves the nut portion 24 from the non-contact position (see FIG. 5) to a position (initial position) where it contacts the plunger 20 corresponding to the initial filling amount. Further, the medicinal-solution administration device 1 pushes the nut portion 24 until the medicinal solution in the reservoir 18 is pressed by the plunger 20 and the insides of the lead-out tube 29 and the connecting needle tube are filled with the medicinal solution (priming completion position).
  • the priming operation may move the nut portion 24 at a faster speed than when administering the drug solution into the living body. That is, the rotation speed of the motor 44 during priming may be higher than the rotation speed of the motor during drug solution administration. Therefore, when the reservoir 18 is filled with a small amount of liquid medicine, the priming operation causes the nut portion 24 to travel a longer distance, and the administration operation in the administration cycle causes the nut portion 24 to travel a shorter distance. When the reservoir 18 is filled with more liquid, the priming operation will move the nut portion 24 a shorter distance, and the dosing action in the dosing cycle will move the nut portion 24 a longer distance.
  • the power consumption required to move the nut portion 24 in the priming operation is the power consumption required to move the nut portion 24 in the operation of injecting the drug solution into the living body. less than This is because the flow path of the drug-solution administration device 1 is not fluidly connected to the cannula placed in the living body during the priming operation, but the flow path of the drug-solution administration device 1 is connected to the cannula placed in the body in the administration operation. This is because the load on the motor 44 is higher than that during the priming operation because the drug solution needs to be administered against the living tissue at the tip of the connected and indwelling cannula.
  • the pulse width of the pulse applied to the motor 44 must be wider than that during the priming operation.
  • the pulse width of the pulse applied to the motor 44 during the priming operation and the administration operation is preliminarily determined based on the assumed load and rotation speed of the motor 44 so as to prevent step-out and to achieve low power consumption. Based on this, the control section 71 can change the pulse width of the pulse applied to the motor 44 during the priming operation and during the administration operation.
  • the amount of power consumed until the end of administration of the drug solution filled in the cartridge 12 is the initial amount of the drug solution filled in the reservoir 18. Varies depending on Therefore, without considering the initial amount of the liquid medicine in the cartridge 12 (that is, the filling amount), it is impossible to accurately calculate how many times the cartridge 12 can be replaced with respect to the power remaining in the battery 42 of the apparatus main body 14. .
  • the drug-solution administration device 1 calculates the number of times the cartridge 12 can be replaced based on the priming power amount, the liquid transfer power amount, and the power amount remaining in the battery 42 .
  • the priming electric energy is the electric energy required to move the nut portion 24 until the flow path of the medical-solution administration device 1 is filled with the medical solution (that is, priming).
  • the liquid feeding power amount is the power amount used from the start of liquid medicine administration to the end of liquid medicine administration after priming makes it possible to start liquid medicine administration.
  • the amount of power to send the liquid is the amount of power required to administer the drug solution filled in the reservoir 18 to the patient.
  • the priming power amount and the liquid feeding power amount are values corresponding to the filling amount of the chemical solution. Therefore, according to the drug-solution administration device 1 according to the present embodiment, it is possible to accurately measure the number of times the cartridge 12 can be replaced.
  • FIG. 9 is a flow chart showing the operating procedure of the medicinal-solution administration device 1 of FIG.
  • FIG. 10 is a flow chart showing the procedure of the rotational speed measurement process of FIG.
  • the operation of the medicinal-solution administration device 1 described with reference to FIGS. 9 and 10 can correspond to one control method of the medicinal-solution administration device 1 .
  • 9 and 10 can be executed under the control of the control unit 71 of the drug-solution administration device 1 or the control unit 91 of the remote control 90.
  • FIG. The following process may be executed, for example, after the cartridge 12 is replaced, the apparatus body 14 of the drug-solution administration apparatus 1 is connected to the cartridge 12, and the priming operation is instructed via the remote controller 90. .
  • step S ⁇ b>1 the control unit 71 of the medicinal-solution administration device 1 measures the remaining power of the battery 42 .
  • the control unit 71 may measure the remaining power level of the battery 42 by measuring the voltage or impedance of the battery 42 .
  • step S2 the control unit 71 of the medicinal-solution administration device 1 estimates the required power amount for one cycle from history information regarding past medicinal-solution administration. Specifically, when performing a priming operation and drug solution administration, the control unit 71 stores information on power consumption required for these operations in the storage unit 72 in advance. The control unit 71 may measure the power consumption based on the difference in the remaining power of the battery 42 measured before and after the operation. The storage unit 72 stores the measured power consumption required for the priming operation and the drug solution administration together with date and time information. In step S2, the control unit 71 refers to these pieces of information to estimate the required power amount for one administration cycle.
  • control unit 71 may estimate the same power consumption as the power consumption required for the priming operation and drug solution administration in the immediately preceding administration cycle as the required power amount for one administration cycle.
  • control unit 71 may estimate the average value of power consumption required for the priming operation and drug solution administration in the last fixed number of administration cycles as the required power amount for one administration cycle.
  • the amount of electric power for administering the amount of medicinal-solution previously input by the patient is reduced to one administration cycle. You may estimate as a required electric energy.
  • the amount of power required to dispense the maximum fillable amount of reservoir 18 may be the default value and the maximum amount of power required for one dosing cycle.
  • step S3 the control unit 71 of the medicinal-solution administration device 1 determines whether or not the current remaining battery level obtained in step S1 exceeds the required power amount for one administration cycle estimated in step S2. . If it exceeds (YES in step S3), the controller 71 proceeds to step S4, otherwise (NO in step S3), it proceeds to step S9. In step S3, the control unit 71 may proceed to step S4 even when the current remaining battery level obtained in step S1 is the same as the required power amount for one administration cycle estimated in step S2.
  • step S1 if the current remaining battery level value acquired in step S1 is less than a predetermined value (for example, 10% of the maximum chargeable power amount of the battery 42), the control unit 71 The process may proceed to step S9 irrespective of the amount of power required for each minute.
  • a predetermined value for example, 10% of the maximum chargeable power amount of the battery 42
  • step S4 the control unit 71 of the medicinal solution administration device 1 executes rotation speed measurement processing for measuring the rotation speed of the motor 44 in order to measure the position of the nut part 24 corresponding to the filling amount of the medicinal solution.
  • the nut portion 24 is in the non-contact position where it does not contact the plunger 20 .
  • the control unit 71 of the medicinal-solution administration device 1 starts rotating the motor 44 in the reverse direction. This causes the nut portion 24 to move away from the plunger 20 . At this time, the nut portion 24 rotates in the reverse direction to a predetermined position.
  • the predetermined position is, for example, a position where the slide portion 60 is restricted from retreating by a stopper provided on the guide wall 68 or a position at the rearmost end of the feed screw shaft 22 .
  • the motor 44 steps out.
  • step S12 the control unit 71 of the medicinal-solution administration device 1 determines whether or not the motor 44 has stepped out. If step-out occurs (YES in step S12), the control unit 71 proceeds to step S13. Otherwise (NO in step S12), the control unit 71 continues the reverse rotation of the motor 44 and performs the process of step S12 again.
  • the motor 44 is out of step, the nut portion 24 is at a predetermined position. Here, the nut portion 24 is aligned by moving the nut portion 24 to a predetermined position. As a result, even if the nut portion 24 moves unintentionally while the cartridge 12 is being prepared, it is possible to maintain the accuracy of estimating the number of exchanges of the cartridge 12, which will be described later.
  • step S13 the control unit 71 of the medicinal-solution administration device 1 saves in the storage unit 72 the number of reverse rotations of the motor 44 from the start of reverse rotation in step S11 until step-out.
  • step S14 the control unit 71 of the medicinal-solution administration device 1 starts rotating the motor 44 forward.
  • the nut portion 24 moves toward the plunger 20, and eventually the nut portion 24 and the plunger 20 are engaged with each other.
  • the plunger 20 is pushed by the nut portion 24 to apply pressure to the liquid medicine in the reservoir 18, and priming is performed in which the flow path of the liquid medicine administration device 1 is filled with the liquid medicine.
  • a user such as a patient observes the tip of the connecting needle tube, and when confirming that the drug solution has flowed out from the tip of the connecting needle tube, instructs the drug-solution administration device 1 to stop priming.
  • the user may instruct the drug-solution administration device 1 to stop priming by selecting the image of the priming stop button displayed on the display of the output unit 95 of the remote controller 90 .
  • step S15 the control unit 71 of the medicinal-solution administration device 1 determines whether or not the user has selected the priming stop button. If the priming stop button is selected (YES in step S15), the control unit 71 proceeds to step S16. I do.
  • step S16 the control unit 71 of the medicinal-solution administration device 1 stops the rotation of the motor 44.
  • step S17 the control unit 71 of the medicinal-solution administration device 1 stores in the storage unit 72 the number of forward rotations of the motor 44 from the start of forward rotation in step S14 until the rotation is stopped. Then, the control unit 71 ends the rotational speed measurement process, and proceeds to step S5 in FIG.
  • step S5 of FIG. 9 the control unit 71 of the drug-solution administration device 1 estimates the electric energy required for the priming operation (priming electric energy) based on the rotation speed of the motor 44 measured by the rotation speed measurement process in step S4. do.
  • the control unit 71 acquires the amount of electric power consumed by one rotation of the motor 44 stored in advance in the storage unit 72, and multiplies this value by the number of revolutions of the motor 44 to obtain the amount of power required for the priming operation.
  • the amount of power may be estimated.
  • the rotation speed of the motor 44 is the sum of the reverse rotation speed saved in step S13 of FIG. 10 and the forward rotation speed saved in step S17.
  • step S6 the control unit 71 of the medicinal-solution administration device 1 estimates the amount of power (liquid-feeding power) required to administer the medicinal solution based on the amount of medicinal solution filled in the reservoir 18 .
  • the control unit 71 may acquire the forward rotation speed saved in step S17 of FIG. 10, and acquire the filling amount of the chemical solution corresponding to the forward rotation speed.
  • the control unit 71 may acquire the liquid feeding power amount corresponding to the filling amount of the chemical liquid.
  • the control unit 71 stores in the storage unit 72 in advance a table indicating the correspondence relationship between the forward rotation speed, the amount of liquid medicine filled, and the amount of electric power for feeding the liquid. may be acquired.
  • step S7 the control unit 71 of the medicinal-solution administration device 1 measures the remaining power of the battery 42. Specifically, similarly to step S ⁇ b>1 , the controller 71 may measure the remaining power level of the battery 42 by measuring the voltage or impedance of the battery 42 .
  • step S8 the control unit 71 of the medicinal-solution administration device 1 controls the cartridge 12 (disposable unit ) can be exchanged. Specifically, the control unit 71 may calculate the number of replacement times by dividing the remaining battery level acquired in step S7 by the total value of the priming power amount and the liquid transfer power amount. The control unit 71 may calculate a value obtained by truncating the value calculated by the division to the first decimal place as the possible number of exchanges. The control unit 71 may display the calculated number of possible exchanges on the display of the output unit 95 of the remote controller 90 . Specifically, the control unit 71 may notify the remote controller 90 of the number of possible exchanges via the communication unit 73 . The control unit 91 of the remote controller 90 may display the value on the display of the output unit 95 in response to the notification of the number of possible exchanges. After completing the process of step S8, the control unit 71 ends the process of the flowchart.
  • step S9 the control unit 71 of the medical-solution administration device 1 notifies the user of the power shortage.
  • the power shortage may be notified to the remote controller 90 via the communication unit 73 .
  • the control unit 91 of the remote controller 90 may display an image indicating power shortage on the display of the output unit 95 in response to the notification from the medical-solution administration device 1 .
  • the control unit 91 may notify the user of the power shortage by outputting an audio signal, vibrating, or the like from the output unit 95 in addition to the image display or instead of this.
  • the drug-solution administration device 1 injects the medicinal solution filled in the reservoir 18 into the living body by the pressing action of the plunger 20 .
  • the drug-solution administration device 1 includes a reservoir 18 , a plunger 20 , a nut portion 24 , a drive portion 40 , a battery 42 and a control portion 71 .
  • a reservoir 18 is provided in the disposable cartridge 12 that is detachably connected, and is filled with a 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.
  • a battery 42 supplies power for driving the drive unit 40 .
  • the control unit 71 calculates the number of exchangeable times, which is the number of times the cartridge 12 can be exchanged, based on the priming electric energy, the liquid feeding electric energy, and the electric energy remaining in the battery 42 .
  • the priming power amount is the amount of power required to move the nut portion 24 until the flow path of the drug solution administration device 1 is filled with the drug solution.
  • the liquid feeding power amount is the power amount required to administer the drug solution filled in the reservoir 18 .
  • the control unit 71 presents the calculated number of possible exchanges to the user.
  • the drug-solution administration device 1 calculates the number of times the cartridge 12 can be replaced based on the priming power amount, the liquid transfer power amount, and the power amount remaining in the battery 42. , it is possible to accurately measure the number of exchangeable times.
  • the reservoir 18, plunger 20, and nut portion 24 are provided in the cartridge 12, and the driving portion 40, control portion 71, and battery 42 are provided in the main body 14 of the device. configuration.
  • the nut portion 24 may be provided on the device main body 14 , or at least one of the driving portion 40 and the control portion 71 may be provided on the cartridge 12 .
  • the driving section 40 may move the nut section 24 by transmitting the driving force based on the rotation of the motor 44 .
  • the control unit 71 may estimate the priming power amount and the liquid feeding power amount based on the number of rotations of the motor 44 that is rotated to move the nut part 24 until the flow path of the liquid medicine administration device 1 is filled with the liquid medicine. .
  • the drug-solution administration device 1 estimates the priming power amount and the liquid feeding power amount based on the number of revolutions of the motor 44, and calculates the number of times the cartridge 12 can be replaced. It is possible to measure accurately.
  • control unit 71 may calculate the number of exchanges possible by dividing the amount of power remaining in the battery 42 by the total value of the priming power amount and the liquid feeding power amount. As described above, since the medicinal-solution administration device 1 according to the present embodiment calculates the allowable number of exchanges by simple calculation, it is possible to easily obtain the allowable number of exchanges.
  • control unit 71 may cause the display device to display the calculated number of possible exchanges. This allows the user to easily recognize the number of times the cartridge 12 can be replaced.
  • the medicinal-solution administration device 1 displays the remaining amount on the display of the output unit 95 of the remote control 90, but if the medicinal-solution administration device 1 itself has a display device, the remaining amount is displayed on the display device.
  • the medicinal-solution administration device 1 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.
  • the medicinal-solution administration device 1 can accurately grasp the remaining battery level of the device body 14, which is a reusable part, as the number of times the cartridge 12 can be replaced. As a result, the user can take measures such as charging the apparatus body 14 in advance or replacing the battery 42 with a new one before the battery 42 runs out. Also, the remaining battery capacity of the device body 14 can be used efficiently.

Landscapes

  • 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

Ce dispositif d'administration de solution médicamenteuse comprend : un réservoir; un trajet d'écoulement qui est relié au réservoir et guide la solution médicamenteuse hors du réservoir; un piston qui peut se déplacer dans la direction longitudinale du réservoir; une unité mobile qui se déplace et peut ainsi presser le piston contre le côté d'extrémité distale du réservoir; une unité d'entraînement qui déplace l'unité mobile; une batterie qui fournit de l'énergie électrique; et une unité de commande. Le réservoir est disposé sur une cartouche jetable qui est reliée de manière amovible au dispositif d'administration de solution médicamenteuse. L'unité de commande calcule le nombre de remises en place, c'est-à-dire le nombre de fois où la cartouche a été remise en place, sur la base d'une quantité d'énergie d'amorçage qui est une quantité d'énergie requise pour déplacer l'unité mobile jusqu'à ce que le trajet d'écoulement du dispositif d'administration de solution médicamenteuse soit rempli d'une solution médicamenteuse, d'une quantité d'énergie d'alimentation en liquide qui correspond à une quantité d'énergie requise pour administrer la solution médicamenteuse remplissant le réservoir et d'une quantité d'énergie restant dans la batterie, et présente le nombre calculé de remises en place à un utilisateur.
PCT/JP2022/034105 2022-01-07 2022-09-12 Dispositif d'administration de solution médicamenteuse, son procédé de commande et système d'administration de solution médicamenteuse WO2023132103A1 (fr)

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JP2022-001896 2022-01-07
JP2022001896 2022-01-07

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090069746A1 (en) * 2007-09-07 2009-03-12 M2 Medical Group Holdings, Inc. Data Storage for an Infusion Pump System
US20090069749A1 (en) * 2007-09-07 2009-03-12 M2 Medical Power Management Techniques for an Infusion Pump System
JP2011521744A (ja) * 2008-05-30 2011-07-28 アラーガン、インコーポレイテッド 軟質組織増強充填剤、生物活性剤および液状又はゲル状の他の生体適合材料を注入するための注入装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20090069746A1 (en) * 2007-09-07 2009-03-12 M2 Medical Group Holdings, Inc. Data Storage for an Infusion Pump System
US20090069749A1 (en) * 2007-09-07 2009-03-12 M2 Medical Power Management Techniques for an Infusion Pump System
JP2011521744A (ja) * 2008-05-30 2011-07-28 アラーガン、インコーポレイテッド 軟質組織増強充填剤、生物活性剤および液状又はゲル状の他の生体適合材料を注入するための注入装置

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