WO2016151973A1 - Device for administering liquid medicine - Google Patents

Device for administering liquid medicine Download PDF

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Publication number
WO2016151973A1
WO2016151973A1 PCT/JP2015/086542 JP2015086542W WO2016151973A1 WO 2016151973 A1 WO2016151973 A1 WO 2016151973A1 JP 2015086542 W JP2015086542 W JP 2015086542W WO 2016151973 A1 WO2016151973 A1 WO 2016151973A1
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WO
WIPO (PCT)
Prior art keywords
liquid
unit
data
liquid feeding
amount
Prior art date
Application number
PCT/JP2015/086542
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French (fr)
Japanese (ja)
Inventor
和明 香川
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 WO2016151973A1 publication Critical patent/WO2016151973A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172Means 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 electrical or electronic

Definitions

  • the present invention relates to a chemical solution administration device used for administering a chemical solution into a living body.
  • a portable chemical solution administration device that administers a chemical solution while being attached to the skin of a user (patient, subject, etc.) to be administered is known.
  • a plurality of administrations are performed during a predetermined period of time in accordance with the user's life rhythm, etc. Sometimes.
  • the administration is repeated a plurality of times as described above, the previously administered drug solution may remain in the living body when the administration is started. If a chemical solution is administered without taking into consideration any residual amount in a state where the chemical solution remains in the living body, there is a possibility that the chemical solution is excessively administered in the living body.
  • Patent Document 1 discloses an appropriate administration that estimates the remaining amount of a drug solution in a living body based on the dose of the drug solution and the time when the drug solution is administered, and considers the estimated remaining amount.
  • a chemical solution administration device that performs a liquid feeding operation so that an amount of a chemical solution can be delivered is disclosed.
  • the user can administer the chemical solution using a single-use liquid delivery device in which a predetermined amount of chemical solution is stored. May be implemented. After replacing the administration of the chemical solution with such a liquid delivery device, when the liquid delivery of the chemical solution is resumed by using the portable chemical solution administration device again, as described above, the already administered chemical solution is in the living body. It is necessary to set the dose of the drug solution at the time of resumption after considering how much remains.
  • the chemical solution administration device described in Patent Document 1 estimates and grasps the remaining amount of the administered chemical solution when the chemical solution is administered by a liquid delivery device or device other than the chemical solution administration device. It is not configured as such. For this reason, the remaining amount of the chemical solution administered by another liquid delivery device or apparatus is not reflected in the dose when the administration of the chemical solution by the chemical solution administration device is resumed. Accordingly, there is a possibility that a chemical solution is not delivered at an appropriate dose, and problems such as excessive administration of the chemical solution may occur.
  • the present invention provides a chemical solution administration device that can administer a chemical solution with an appropriate liquid delivery amount based on the remaining amount in consideration of the residual amount of the chemical solution administered by another liquid delivery device or the like in the living body.
  • the purpose is to do.
  • the liquid medicine administration device includes a liquid feeding section that feeds a liquid medicine into a user's living body, a control section that controls a liquid feeding operation by the liquid feeding section, and the liquid feeding section that feeds the living body into the living body.
  • Liquid feeding data capable of acquiring first data related to the liquid feeding amount of the liquid chemical and liquid second data relating to the liquid feeding amount of the liquid chemical delivered by the liquid feeding device other than the liquid feeding unit into the living body.
  • the remaining amount of the drug solution in the living body is calculated, and the drug solution to be administered to the living body based on the remaining amount of the drug solution
  • a calculation unit that calculates a liquid feeding scheduled amount, and the control unit controls a liquid feeding operation of the liquid feeding unit so that the liquid feeding amount of the chemical solution is fed to the living body. It is characterized by doing.
  • the liquid medicine administration device when the liquid medicine is delivered (administered) by a liquid delivery device other than the liquid medicine administration apparatus, data relating to the amount of liquid delivery is obtained, and if necessary, Based on the data, the remaining amount of the chemical solution in the living body is calculated, and further, an appropriate liquid delivery amount based on the remaining amount of the chemical solution is calculated. And, since the operation of the liquid feeding part is controlled by the control part so that the calculated liquid feeding amount is calculated, the liquid medicine is administered by another liquid feeding device or the like. In this case, it is possible to administer the drug solution with an appropriate liquid feeding amount in consideration of the remaining amount of the drug solution in the living body.
  • FIG. 3A is a top view of the injection part provided in the liquid feeding part
  • FIGS. 3B and 3C are cross-sectional views taken along the line 3B-3B in FIG.
  • FIG. 4A is a plan view schematically showing the structure of each part of the liquid feeding part
  • FIG. 4B is a cross-sectional view taken along line 4B-4B of FIG. 4A.
  • FIG. 5A is a diagram illustrating a liquid feeding mode of the drug solution administration device according to the embodiment
  • FIG. 5B is a diagram illustrating a change over time in the remaining amount of the drug solution administered into the living body according to the embodiment. is there.
  • It is a block diagram which shows the whole structure of the chemical
  • It is a figure which shows the flowchart of the operation process which a controller implements.
  • FIG. 9A is a diagram showing a change over time in the amount of liquid medicine delivered to the living body by the liquid medicine administration set according to the embodiment, and
  • FIG. 9A shows the state after the administration by the liquid medicine administration apparatus.
  • FIG. 9 (B) is a diagram showing an example of when administration by the chemical solution is resumed, and FIG. 9B shows an example when administration by the chemical solution administration device is resumed after administration by a liquid delivery device other than the chemical solution administration device FIG. It is a figure which shows the time change of the liquid feeding amount of the chemical
  • FIG. 1 is a diagram for explaining the configuration of each part of the drug solution administration set according to the embodiment
  • FIGS. 2 to 4 are diagrams for explaining the configuration of each part of the drug solution administration device according to the embodiment.
  • FIG. 5 is a diagram showing the relationship between the liquid delivery mode of the drug solution administration device and the change over time of the remaining amount of the drug solution
  • FIG. 6 is a block diagram showing the overall configuration of the drug solution administration set
  • FIGS. It is a figure which shows the operation processing example of the 1st control part with which a controller is provided, and the 2nd control part with which a liquid feeding part is provided.
  • the medicinal solution administration set 500 is configured as an insulin administration device that delivers insulin as a medicinal solution into a living body of a diabetic patient who is a user.
  • a medicinal solution administration set 500 includes a portable medicinal solution administration device 300 that can be worn on the body, and an insulin pen (corresponding to another liquid delivery device) 400 configured as a pen-type insulin administration device. And have.
  • the drug solution administration device 300 is referred to as an insulin administration device 300.
  • the insulin administration device 300 provided in the medicinal solution administration set 500 includes a liquid supply (M1 in the figure) in a basal mode in which a constant amount of insulin is supplied over time, and per unit time.
  • the liquid supply amount (M2 in the figure) in the bolus mode in which the liquid supply amount of insulin is temporarily increased to be supplied is configured in accordance with the user's instruction.
  • liquid feeding in a bolus mode is performed immediately before or immediately after performing an action (for example, ingestion of a meal) that increases a blood glucose level.
  • the liquid supply in the basal mode is performed so that the upper limit value and the lower limit value of the blood sugar level are stably maintained within a predetermined range.
  • the user normally administers insulin in the basal mode and the regular bolus mode using the insulin administration device 300.
  • the insulin administration apparatus 300 performs liquid feeding in a bolus mode in which a large amount of insulin is administered, data related to the amount of insulin delivered by the liquid feeding unit 100 in the previous bolus mode (hereinafter referred to as “first data”).
  • first data data related to the amount of insulin delivered by the liquid feeding unit 100 in the previous bolus mode
  • residual insulin amount is estimated on the basis of the residual insulin amount, and the liquid delivery scheduled amount is calculated based on the residual insulin amount.
  • the insulin pen 400 is appropriately used instead of the insulin administration in the bolus mode of the insulin administration device 300 to administer the prescribed amount of insulin. May do.
  • the insulin pen 400 is configured to transmit data (hereinafter referred to as “second data”) relating to the amount of liquid delivered by the insulin pen 400 to the insulin administration device 300. Then, when insulin is administered again in the bolus mode using the insulin administration device 300, the insulin administration device 300 uses the second data received from the insulin pen 400 in place of the first data to determine the remaining insulin amount. Configured to calculate.
  • FIG. 9A shows a state in which the insulin administration apparatus 300 performs liquid feeding twice in the bolus mode.
  • the insulin administration device 300 calculates the remaining amount of insulin based on the first data including the amount of liquid delivery V 0 in the first bolus mode, and the second amount of liquid delivery scheduled for the second time based on the amount of remaining insulin.
  • V n is calculated.
  • FIG. 9B shows a state in which the insulin of the specified amount V 0 is first administered by the insulin pen 400 and then the liquid is fed in the bolus mode using the insulin administration device 300.
  • the insulin administration device 300 calculates the residual insulin amount based on the second data including the liquid delivery amount V 0 of the insulin delivered by the insulin pen 400, and based on the insulin residual amount, the insulin delivery device 300 delivers the insulin in the bolus mode. to calculate the liquid predetermined amount V n.
  • the medicinal solution administration set 500 even when the insulin administration device 300 and the insulin pen 400 are used in combination, it is possible to deliver an appropriate amount of medicinal solution based on the residual insulin amount. .
  • the insulin administration device 300 will be described.
  • an insulin administration device 300 includes a liquid feeding unit 100 that performs a liquid feeding operation for feeding insulin, which is a drug solution, into a living body, and a controller 200 that instructs the liquid feeding unit 100 to perform various operations. And.
  • the controller 200 includes a receiving unit 230 that can receive the instruction content from the user, and should deliver a predetermined amount of insulin (hereinafter referred to as “scheduled amount of insulin”) based on the instruction content.
  • a liquid delivery instruction to that effect is transmitted to the liquid delivery unit 100.
  • the user can give a liquid feeding instruction to the liquid feeding unit 100 by operating the controller 200 separate from the liquid feeding unit 100 in a state where the liquid feeding unit 100 is attached to his / her body. ing.
  • the liquid delivery unit 100 will be described.
  • the liquid feeding unit 100 is attached to a user's body and configured to be connected to and separated from the injection unit 10 including a cannula 11 and the like placed in the user's body.
  • a disposable liquid feeding disposable unit 20 including a syringe 22 filled with insulin, and a reusable unit configured to be connected to and separated from the liquid feeding disposable unit 20 and driving a liquid feeding operation.
  • a liquid feed reuse unit 30 a liquid feed reuse unit 30.
  • the insulin administration device 300 can be used repeatedly by replacing the liquid delivery disposable unit 20 with a new one as necessary when the insulin in the syringe 22 provided in the liquid delivery disposable unit 20 becomes empty. Reusability is provided.
  • the injection unit 10 will be described.
  • the injection part 10 has a cannula 11, a support member 12 that supports the cannula 11, a flat plate-like placement part 13 a, and a vertical projection that protrudes from a part of the outer peripheral edge of the placement part 13 a.
  • the injection part holding member (cradle) 13 provided with the wall part 13b, and the sticking part 14 which is provided in the back surface side of the injection part holding member 13, and affixes the injection part 10 to a user's body.
  • the injection part holding member 13 is provided with an engaging part (not shown) for maintaining a mechanically connected state with the liquid delivery disposable part 20.
  • This engaging part can be constituted by, for example, a protrusion or a depression that can be fitted to a protrusion or a depression formed on the liquid feeding disposable part 20 side.
  • the mounting portion 13 a of the injection portion holding member 13 is provided with an insertion hole 13 c through which the cannula 11 can be inserted.
  • the support member 12 has a main body 12a formed in a substantially cylindrical shape.
  • the main body portion 12a is provided with a connecting portion 12b to which a liquid feeding pipe 23 (see FIG. 4B) provided in the liquid feeding disposable portion 20 is coupled.
  • the cannula 11 is configured to protrude from the bottom surface of the main body 12a.
  • a flow path 12c is provided in the main body 12a to allow the connecting portion 12b to communicate with the internal flow path (lumen) of the cannula 11 when the cannula 11 protrudes from the main body 12a.
  • 3 (B) and 3 (C) simply show the state before and after the cannula 11 is projected from the main body portion 12a.
  • the pasting part 14 is comprised by the substantially rectangular sheet-like member. Adhesiveness is added to the surface (back surface) of the sticking portion 14 opposite to the surface disposed facing the back surface of the injection portion holding member 13.
  • the injection part 10 can be affixed to a user's body using the adhesiveness of the affixing part 14.
  • a removable release paper that covers and protects the sticking portion 14 may be used to prevent the sticking portion 14 from being inadvertently stuck.
  • the user sticks the injection part 10 to his body (skin surface) via the sticking part 14.
  • the cannula 11 is in a state of being accommodated in the main body 12a.
  • the cannula 11 is protruded from the main body portion 12a toward the user's living body by using a puncture tool 15 which is a dedicated instrument used for introduction into the living body.
  • the puncture device 15 includes a gripping portion 15a that can be gripped by a user with a finger, and a puncture needle 15b having a sharp needle tip. .
  • the puncture needle 15b is housed inside the grip portion 15a.
  • the puncture device 15 when the puncture device 15 is attached to the upper surface portion of the main body 12a and the puncture device 15 is rotated with respect to the main body 12a, the puncture is performed as shown in FIG.
  • the needle 15b passes through the lumen of the cannula 11, and protrudes from the lower surface side (back surface side) of the main body 12a together with the cannula 11.
  • the liquid feeding disposable part 20 and the liquid feeding reuse part 30 can be attached to the injection part 10.
  • a sealing material 12d made of an elastic material or the like is inserted into a portion through which the puncture needle 15b is inserted in the upper surface portion of the main body portion 12a so that the sealing performance with the outside is ensured even after the puncture needle 15b is removed. Is installed.
  • 4A shows the liquid feeding unit 100 in a state where the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30 are connected.
  • the portion surrounded by the broken line X is housed in the liquid feeding disposable unit 20, and the portion surrounded by the broken line Y is housed in the liquid feeding reuse unit 30.
  • the liquid delivery disposable part 20 includes a liquid delivery disposable part holding member 21 placed on the injection part holding member 13, a syringe 22 filled with insulin, and an injection. And a liquid feeding pipe 23 that communicates the connecting part 12b provided in the part 10 with the syringe 22.
  • the liquid feeding disposable part 20 further meshes with a pusher 24 that slides in the syringe 22 and feeds the insulin in the syringe 22 to the liquid feeding pipe 23, and a female screw part 24 d formed on the pusher 24.
  • a feed screw 25 that feeds the pusher 24 into the syringe 22, a gear 26 that transmits the rotational force from the drive unit 35 of the liquid-feed reuse unit 30 to the feed screw 25, and a battery 27 that supplies power to the drive unit 35, etc. ,have.
  • the pusher 24 includes a push plate 24a that slides inside the syringe 22 while maintaining a sealing property, a feed plate 24b having an internal thread portion 24d, and the push plate 24a and the feed plate 24b. And a connecting plate 24c connected to each other.
  • a part of the feed screw 25 is meshed with the female screw portion 24d of the feed plate 24b. Further, the base end portion of the feed screw 25 is fixed to the gear 26.
  • the feed plate 24 b moves on the feed screw 25.
  • the push plate 24a connected to the feed plate 24b via the connecting plate 24c slides in the syringe 22 as the feed plate 24b moves.
  • the liquid feeding tube 23 is constituted by a thin metal tube that fluidly communicates the inside of the syringe 22 and the connecting portion 12b of the cannula 11 with each other.
  • the tip of the liquid delivery pipe 23 is connected to the injection part 10 as shown in FIG. It is inserted into the part 12b.
  • a sealing material (not shown) made of an elastic member or the like is installed at a portion of the connecting portion 12b into which the liquid feeding pipe 23 is inserted, whereby the connecting portion 12b and the liquid feeding pipe 23 can be liquid-tightly connected.
  • the battery 27 is electrically connected to the drive unit 35 (motor 32) in the liquid feeding reuse unit 30 when the liquid feeding disposable unit 20 is connected to the liquid feeding reuse unit 30. As a result, power can be supplied from the battery 27 to the drive unit 35.
  • the battery 27 is also electrically connected to the second communication unit 40 and the second control unit 50 housed in the liquid feeding and reuse unit 30, and supplies power to each of them.
  • the liquid feeding reuse unit 30 includes a liquid feeding reuse part holding member 31 coupled to the liquid feeding disposable holding member 21 and a motor electrically connected to the battery 27. 32, a rotation shaft 33 that is rotationally driven by the motor 32, and a plurality of gears 34 that transmit the rotation of the rotation shaft 33 to the feed screw 25.
  • the driving unit 35 that drives the liquid feeding operation of the liquid feeding unit 100 includes a motor 32, a rotating shaft 33, and a gear 34.
  • the liquid feeding reuse portion holding member 31 is configured as a case (casing) that covers the liquid feeding disposable portion holding member 21.
  • Each component of the liquid feeding reuse unit 30 described above is accommodated in the liquid feeding disposable holding member 21.
  • the motor 32 is arranged at a position where it can be electrically connected to the battery 27 of the liquid delivery disposable part 20 when the liquid delivery reuse part 30 is connected to the liquid delivery disposable part 20. Is done.
  • the plurality of gears 34 include a first gear coupled to the rotation shaft 33 of the motor 32, a second gear meshed with the gear 26 provided in the liquid delivery disposable unit 20, and the first and second gears. A third gear disposed between and meshed with each gear is included.
  • the gear 34 is simply constituted by a first gear and a second gear.
  • the user When using the insulin administration device 300, the user first connects and integrates the liquid feeding disposable unit 20 and the liquid feeding reuse unit 30. And the liquid feeding disposable part 20 and the liquid feeding reuse part 30 which were integrated are connected with respect to the injection
  • the user performs priming for filling insulin in the liquid feeding tube 23 of the liquid feeding disposable part 20 before connecting the integrated liquid feeding disposable part 20 and the liquid feeding reuse part 30 to the injection part 10.
  • I do Specifically, by operating the drive unit 35 and moving the pusher 24 by a predetermined amount, the insulin accommodated in the syringe 22 is fed to the liquid feeding tube 23, and the insulin is fed into the liquid feeding tube 23. To fill.
  • the controller 200 includes a controller main body 210, a display unit 220 provided in the controller main body 210, a reception unit 230 that can receive instructions from a user, and power to each unit of the controller 200. And a power supply unit 240 for supplying power.
  • the display unit 220 can be configured by a liquid crystal display, for example.
  • the display unit 220 can display information necessary for the user to operate the insulin administration device 300, the progress of the liquid feeding operation, and the like.
  • the receiving unit 230 has a plurality of buttons, and receives instruction contents from the user by button operation.
  • the accepting unit 230 includes, for example, a button for selecting a basal mode, a bolus mode, a priming operation, and the like, a button for switching display contents of the display unit 220, and the like.
  • the controller 200 includes a first communication unit 250 that can wirelessly communicate with the liquid feeding unit 100 and a first control unit 260 that controls the insulin administration device 300 in an integrated manner.
  • the liquid feeding reuse unit 30 of the liquid feeding unit 100 supervises the operation of the liquid feeding unit 100 in response to an instruction from the first control unit 260 and the second communication unit 40 that can wirelessly communicate with the controller 200 and the insulin pen 400. And a second control unit 50 to be controlled.
  • the first communication unit 250 of the controller 200 and the second communication unit 40 of the liquid feeding unit 100 use BLE (Bluetooth Low Energy) communication, which is a short-range wireless communication technology capable of performing communication with low power, to each other. It is possible to send and receive information.
  • BLE Bluetooth Low Energy
  • the second communication unit 40 of the liquid feeding unit 100 also has a function as a data acquisition unit that acquires second data transmitted from a third communication unit 450 of the insulin pen 400 described later by a wireless communication function.
  • the first control unit 260 of the controller 200 and the second control unit 50 of the liquid feeding unit 100 are configured by a known microcomputer including a CPU, a RAM, a ROM, and the like.
  • the CPU included in each of the first control unit 260 and the second control unit 50 reads various programs stored in advance in the ROM into the RAM and executes them, thereby performing predetermined operation control described later.
  • an insulin pen 400 is housed in a pen-shaped main body 410, an injection needle 420 provided at the tip of the main body 410, and the main body 410, and is filled with insulin.
  • the insulin pen 400 includes a third communication unit 450 that can wirelessly communicate with the liquid feeding unit 100 of the insulin administration device 300, a third control unit 460 that performs overall control of the operation of the insulin pen 400, and the insulin pen 400.
  • a battery 470 for supplying power to each unit.
  • the 3rd communication part 450 can transmit / receive information mutually with the 2nd communication part 40 with which the liquid feeding part 100 is provided using BLE (Bluetooth Low Energy) communication.
  • BLE Bluetooth Low Energy
  • the third control unit 460 is configured by a known microcomputer including a CPU, RAM, ROM, and the like.
  • the CPU included in the third control unit 460 reads various programs stored in advance in the ROM into the RAM and executes them to execute predetermined operation control described later.
  • the user punctures the body with the injection needle 420, presses the injection button 440, and feeds the insulin filled in the syringe 430 into the living body.
  • the insulin administration device 300 of the medicinal solution administration set 500 calculates the expected amount of insulin to be delivered in the bolus mode based on the following equation 1.
  • the amount of carbohydrate [g] is the amount of carbohydrate ingested in the meal immediately before the user starts feeding in the bolus mode.
  • the insulin carbohydrate ratio [g / unit] is an amount of insulin that can process 1 g of carbohydrate, and is a predetermined value determined for each user.
  • the measured blood glucose level [mg / dL] is a blood glucose level measured before taking a meal.
  • the target blood glucose level [mg / dL] is a target blood glucose level to be adjusted by administration of insulin.
  • the insulin effect value [mg / dL / unit] is a blood glucose level that decreases when one unit of insulin is administered, and is a predetermined value determined for each user.
  • the residual insulin amount [unit] is the amount of insulin that is administered into the living body when the liquid is fed in the previous bolus mode (hereinafter referred to as “previous bolus time”). The remaining insulin amount will be described with reference to FIG.
  • the vertical axis represents the amount of residual insulin
  • the horizontal axis represents the elapsed time from the previous bolus
  • the state where the insulin administered into the living body is consumed and decreased with the passage of time is shown.
  • the amount V 0 of insulin administered at the previous bolus decreases at a predetermined rate with the passage of time, and decreases to V t when ⁇ t has elapsed from the previous bolus.
  • the residual insulin amount can be estimated based on the elapsed time from the previous bolus and the previously administered insulin amount.
  • the residual insulin amount is obtained based on a predetermined expression (hereinafter referred to as “residual insulin relational expression”) representing the relationship between the residual insulin amount and the elapsed time from the previous bolus.
  • a predetermined expression hereinafter referred to as “residual insulin relational expression” representing the relationship between the residual insulin amount and the elapsed time from the previous bolus.
  • the calculation of the “residual insulin amount” and the “scheduled liquid supply amount” in Equation 1 is provided in the first control unit 260 provided in the controller 200, the second control unit 50 provided in the liquid supply unit 100, and the insulin pen 400. This is executed by the third control unit 460. The function of each control unit will be described with reference to the block diagram of the drug solution administration set 500 shown in FIG.
  • the third control unit 460 provided in the insulin pen 400 is connected to the third communication unit 450, the injection button 440, and the battery 470, and controls these operations in an integrated manner. Specifically, when the injection button 440 is pressed, the third control unit 460 detects that liquid feeding has been performed, and the second data is sent from the third communication unit 450 to the liquid feeding unit 100 of the insulin administration device 300. Send.
  • the amount and the delivery end time when the insulin pen 400 finishes delivering the insulin are included.
  • the 2nd control part 50 with which the liquid feeding part 100 is provided is connected to the 2nd communication part 40, the motor 32, and the battery 27, receives these instructions of the 1st control part 260, and controls these operations.
  • the second control unit 50 also includes first data relating to the amount of insulin delivered by the fluid delivery unit 100 to the living body, and second data relating to the amount of insulin delivered by the insulin pen 400 to the living body.
  • the “first data” in the present embodiment includes the amount of insulin delivered by the fluid delivery unit 100 into the living body and the time when the fluid delivery unit 100 finished delivering the insulin in the previous bolus mode.
  • the liquid delivery end time is included.
  • the second control unit 50 acquires the first data from the drive signal of the motor 32 of the liquid feeding unit 100, and acquires the second data transmitted from the insulin pen 400 in the second communication unit 40 as described above. .
  • the receiving unit 230 provided in the controller 200 also has a function corresponding to a data input receiving unit that receives second data input from the user. Therefore, for example, when the wireless communication function of the insulin pen 400 is stopped due to a failure or the like, the user can directly input the second data to the reception unit 230.
  • the data management unit 51 stores a liquid supply amount and a liquid supply end time (hereinafter referred to as “previous bolus data”) at the previous bolus.
  • the data management unit 51 updates the previous bolus data. For example, when the liquid supply unit 100 performs liquid supply in the bolus mode and the second control unit 50 acquires the first data, the first data is stored as the previous bolus data. Thereafter, when the second communication unit 40 acquires the second data, the second data is updated as the previous bolus data.
  • the first control unit 260 included in the controller 200 is connected to the first communication unit 250, the display unit 220, the reception unit 230, and the power supply unit 240, and comprehensively controls these operations.
  • the first control unit 260 calculates a residual insulin amount in the living body based on the first data or the second data, and calculates a liquid delivery scheduled amount based on the residual insulin amount.
  • a function as a storage unit 262 for storing various data necessary for calculation of the calculation unit 261 is provided.
  • the storage unit 262 stores each parameter of the insulin carbohydrate ratio, the target blood glucose level, the insulin effect value, and the residual insulin relational expression as data necessary for the calculation of the calculation unit 261. These parameters can be input in advance by the user via the receiving unit 230 and set prior to use.
  • the first control unit 260 included in the controller 200 receives a liquid feeding instruction in the bolus mode from the user via the reception unit 230
  • the first control unit 260 provides the user with the carbohydrate amount via the display unit 220.
  • Input is instructed (S11).
  • the user who receives the instruction inputs the amount of carbohydrate obtained from the content of the meal taken immediately before, via the input button provided in the reception unit 230.
  • the first control unit 260 instructs the user to input a blood glucose level via the display unit 220 (S12).
  • the user who receives the instruction inputs the blood glucose level before meal measured using a known blood glucose level measuring device or the like via an input button provided in the reception unit 230.
  • the first control unit 260 requests the previous bolus data from the data management unit 51 of the second control unit 50 using the wireless communication function of the first communication unit 250 (S13).
  • the 1st control part 260 receives the last bolus data which the data management part 51 transmitted via the 2nd communication part 40 via the 1st communication part 250 according to the request
  • the calculation unit 261 of the first control unit 260 calculates the remaining insulin amount based on the previous bolus data received in step (S14) (S15). Specifically, when calculating the residual insulin amount, the calculation unit 261 firstly passes an elapsed time from the liquid feeding end time at the previous bolus to the liquid feeding start time at which liquid feeding by the liquid feeding unit 100 is started. Calculate Then, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the calculated elapsed time to the residual insulin relational expression stored in the storage unit 262.
  • the calculation unit 261 acquires the insulin carbohydrate ratio, the insulin effect value, and the target blood glucose level from the storage unit 262 (S16).
  • the calculation unit 261 stores the carbohydrate amount and the measured blood glucose level acquired from the receiving unit 230 in step (S11) and step (S12), the residual insulin amount calculated in step (S15), and the memory in step (S16).
  • the insulin / carbohydrate ratio, the insulin effect value, and the target blood glucose level acquired from the unit 262 are applied to the above-described equation 1 to calculate the liquid feeding scheduled amount (S17).
  • the first control unit 260 uses the wireless communication function of the first communication unit 250 to transmit to the liquid feeding unit 100 a liquid feeding instruction indicating that a predetermined amount of insulin to be delivered in the bolus mode. (S18). After the operation process of step (S18) is completed, the first control unit 260 waits until it receives an instruction from the user again.
  • the above is the operation process when the controller 200 receives a liquid feeding instruction in the bolus mode from the user.
  • the second control unit 50 determines whether or not the signal is a signal transmitted from the insulin pen 400 (S21).
  • step (S21) If it is determined in step (S21) that the received signal is transmitted from the insulin pen 400 (S21; Yes), the data management unit 51 uses the second data acquired from the insulin pen 400 as the previous bolus data. (S22).
  • the second control unit 50 determines whether or not a signal transmitted from the controller 200 is received (S23).
  • Step (S23) when it is determined that the signal transmitted from the controller 200 can be received (S23; No), the second control unit 50 waits until the second communication unit 40 receives the signal again.
  • step (S23) When it is determined in step (S23) that the signal transmitted from the controller 200 is received (S23; Yes), the second control unit 50 determines whether or not the signal requests previous bolus data. Is determined (S25).
  • step (S21) When it is determined in step (S21) that the received signal is not transmitted from the insulin pen 400 (S21; No), the second control unit 50 transmits the signal from the controller 200. It is determined whether or not (S24).
  • step (S24) When it is determined in step (S24) that the received signal is not transmitted from the controller 200 (S24; No), the second control unit 50 displays an error display indicating that the signal has not been received. An instruction signal is transmitted to the first control unit 260 so as to be displayed on the display unit 220. Thereafter, the second control unit 50 stands by until the signal is received again.
  • step (S24) When it is determined in step (S24) that the received signal is transmitted from the controller 200 (S24; Yes), the second control unit 50 requests the previous bolus data. It is determined whether or not (S25).
  • step (S25) If it is determined in step (S25) that the received signal is a request for previous bolus data (S25; Yes), the second control unit 50 stores the previous bolus data stored in the data management unit 51. It transmits to the 1st control part 260 of the controller 200 using the radio
  • step (S26) the second control unit 50 waits again until a signal is received.
  • step (S25) when it is determined that the received signal does not require the previous bolus data (S25; No), the second control unit 50 should carry out liquid feeding in the bolus mode. It is determined whether or not it is an instruction signal to that effect (S31).
  • step (S31) when it is determined that the received signal is an instruction signal indicating that the liquid delivery in the bolus mode should be performed (S31; Yes), the second control unit 50 determines the amount of insulin to be delivered. Then, the motor 32 is electrically controlled so that the liquid is fed in the bolus mode (S32). At this time, the 2nd control part 50 acquires the 1st data containing the amount of liquid feeding which liquid feeding part 100 sent, and liquid feeding end time from the drive signal of motor 32 of liquid feeding part 100.
  • the data management unit 51 updates the first data acquired in step (S32) as the previous bolus data (S33). Thereafter, the second control unit 50 waits again until a signal is received.
  • Step (S31) when it is determined that the received signal is not an instruction signal indicating that the liquid delivery in the bolus mode should be performed (S31; No), the second control unit 50 indicates that the signal is in the basal mode.
  • step S41 it is determined whether or not the instruction signal indicates that liquid feeding is to be performed.
  • step (S41) when it is determined that the received signal is an instruction signal indicating that the liquid feeding in the basal mode should be performed (S41; Yes), the second control unit 50 determines that a predetermined amount of insulin has elapsed over time. Then, the operation of the motor 32 is controlled so that the liquid is fed, and the liquid is fed in the basal mode (S42).
  • step (S41) When it is determined in step (S41) that the received signal is not an instruction signal indicating that the liquid supply in the basal mode should be performed (S41; No), the second control unit 50 performs the first control of the controller 200. The instruction content of the signal received to the unit 260 is confirmed (S43).
  • step (S42) or step (S43) the second control unit 50 waits until a signal is received again.
  • FIG. 9A is a diagram showing an example of liquid feeding when the liquid feeding unit 100 delivers insulin of the liquid feeding amount V 0 in the bolus mode, and the liquid feeding operation is finished at the liquid feeding end time t 0f . .
  • the first data including the liquid feeding amount V 0 and the liquid feeding end time t 0f is stored in the data management unit 51 as previous bolus data.
  • the calculation unit 261 uses the liquid feeding unit based on the liquid feeding end time t 0f. The elapsed time ⁇ t until the liquid feeding start time t n at which liquid feeding is performed by 100 is calculated. Subsequently, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the above-described elapsed time ⁇ t to the residual insulin relational expression. In this case, since the dose is V 0 and the elapsed time is ⁇ t, the residual insulin amount is V t as shown in FIG.
  • the calculation unit 261 calculates the liquid feeding scheduled amount V n by applying the residual insulin amount V t and the like to the above-described equation 1.
  • the second control unit 50 like insulin calculated feeding predetermined quantity V n is fed, by adjusting the amount of rotation of the motor 32 feeding section 100 is provided, the liquid delivery bolus mode carry out.
  • the second control unit 50 the first data including a liquid supply rate V n and feeding end time t nf which is fed this time is acquired from the drive signal of the motor 32 to the liquid feed portion 100.
  • the data management unit 51 updates the first data acquired by the second control unit 50 as the previous bolus data.
  • FIG. 9B while the liquid feeding operation by the liquid feeding unit 100 is stopped, the insulin pen 400 is used to feed the insulin of the liquid feeding amount V 0 and the liquid feeding operation is finished. It is a figure which shows the liquid feeding example at the time of complete
  • the second data including the liquid feeding amount V 0 and the liquid feeding end time t 0f transmitted from the insulin pen 400 is stored in the data management unit 51 as previous bolus data.
  • the calculation unit 261 performs liquid feeding by the liquid feeding unit 100 based on the liquid feeding end time t0f. to calculate the elapsed time ⁇ t until the liquid feeding start time t n. Subsequently, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the above-described elapsed time ⁇ t to the residual insulin relational expression. In this case, since the dose is V 0 and the elapsed time is ⁇ t, the residual insulin amount is V t as shown in FIG.
  • the calculation unit 261 calculates the liquid feeding scheduled amount V n by applying the residual insulin amount V t and the like to the above-described equation 1.
  • the second control unit 50 like insulin calculated feeding predetermined quantity V n is fed, by adjusting the amount of rotation of the motor 32 feeding section 100 is provided, the liquid delivery bolus mode carry out.
  • the second control unit 50 the first data including a liquid supply rate V n and feeding end time t nf which is fed this time is acquired from the drive signal of the motor 32 to the liquid feed portion 100.
  • the data management unit 51 updates the first data acquired by the second control unit 50 as the previous bolus data.
  • the insulin administration device 300 when insulin is administered into the living body by another liquid delivery device such as the insulin pen 400, indicates the remaining amount of the administered insulin in the living body. Considering this, it is possible to determine the amount of insulin to be delivered to an appropriate amount.
  • the insulin administration device 300 when insulin is delivered (administered) by the insulin pen 400 or the like, which is another fluid delivery device other than the insulin administration device 300, the second related to the amount of fluid delivered. Data is acquired, and if necessary, the remaining amount of insulin in the living body is calculated based on the second data, and an appropriate scheduled liquid delivery amount is calculated based on the remaining amount of insulin.
  • the operation of the liquid feeding unit 100 is controlled by each control unit 50 and 260 so that a predetermined amount of liquid medicine is fed, and thus insulin is administered by the insulin pen 400 or the like. In this case, it is possible to administer insulin with an appropriate liquid feeding amount in consideration of the remaining amount of insulin in the living body.
  • the second communication unit 40 is configured to be able to acquire the second data transmitted from the insulin pen 400 by wireless communication, so that the user's manual input is saved. In addition, it is possible to prevent input leakage and the like from occurring.
  • the reception unit 230 has a function corresponding to a data input reception unit that receives the input of the second data from the outside. For this reason, since the insulin administration device 300 can acquire the second data even when liquid feeding is performed using another liquid feeding device or the like that does not have a wireless communication function, the insulin administration device 300 can acquire the second data. It is possible to carry out liquid feeding with an appropriate liquid feeding amount based on the remaining amount of the liquid.
  • the first data includes the liquid delivery end time when the liquid delivery unit 100 finishes delivering the insulin, and the second data finishes the liquid delivery by the insulin pen 400. Therefore, it is possible to calculate a more appropriate remaining amount of the medical solution in the living body based on the passage of time performed immediately before resuming the administration of insulin.
  • the liquid feeding unit 100 is configured to be able to deliver insulin as a chemical solution, and further, per unit time with respect to the basal mode in which a constant amount of insulin is continuously fed. It is configured to be able to perform a liquid feeding operation in a bolus mode in which the amount of insulin delivered is temporarily increased.
  • the first data includes data related to the amount of insulin delivered when the liquid delivery unit 100 operates in the bolus mode
  • the second data includes the liquid delivery operation by the liquid delivery unit 100 being stopped. In the meantime, data on the amount of insulin delivered by the insulin pen 400 is included.
  • the liquid feeding operation of the liquid feeding unit 100 is stopped while the liquid feeding in the bolus mode is being performed, and after the insulin is administered using the insulin pen 400 or the like, the insulin administration device 300 is Even when the administration of insulin is resumed by using the insulin pen, it is possible to administer an appropriate amount of insulin in consideration of the residual amount of the insulin delivered by the insulin pen 400 in the living body.
  • the insulin administration device 300 has a configuration in which the data management unit 51 updates the previous bolus data every time the first data or the second data is acquired. Therefore, the remaining insulin amount is calculated based on either the first data or the second data.
  • the data management unit 51 is configured to store the acquired first data and second data until a predetermined time elapses from the liquid feeding end time of each data.
  • FIG. 10 shows an insulin pen 400 in which the liquid feeding by the liquid feeding unit 100 of the insulin administration device 300 according to the modified example of the embodiment is interrupted due to a failure or the like, and immediately after that, the shortage that the liquid feeding unit 100 could not feed completely.
  • the data management unit 51 stores the first data including the liquid supply amount V 0 and the liquid supply end time t 0f supplied by the liquid supply unit 100 until a predetermined time T elapses from the liquid supply end time t 0f.
  • the second data including the liquid feeding amount V 1 and the liquid feeding end time t 1f sent by the insulin pen 400 is stored until a predetermined time T elapses from the liquid feeding end time t 1f .
  • the calculation unit 261 calculates a residual insulin amount based on the first data and the second data stored in the data management unit 51.
  • the calculation method of the residual insulin amount based on each data is performed by the method similar to the method shown in the embodiment.
  • the calculation unit 261 adds the remaining insulin amounts, and calculates a liquid feeding scheduled amount V n based on the added remaining insulin amounts.
  • the second control unit 50 obtains first data including the liquid supply amount V n and the liquid supply end time t nf to be supplied from the drive signal of the motor 32 included in the liquid supply unit 100.
  • the data management part 51 memorize
  • the predetermined time T an elapsed time until the residual insulin amount becomes 0 when the fluid is delivered at the maximum fluid delivery amount assumed in the bolus mode is selected.
  • the insulin administration device calculates the residual insulin amount based on the first and second data.
  • the drug solution administration device 300 according to the present invention has been described through a plurality of embodiments.
  • the drug solution administration device 300 according to the present invention is not limited to the configuration described in the embodiment, and Various modifications can be made based on the description.
  • insulin is used as the drug solution to be fed, but is not limited thereto.
  • it can also be used for administration of drug solutions such as insulin, antibiotics, nutrients, analgesics, hormones and the like.
  • the calculation method of the amount of the chemical solution remaining in the living body and the planned liquid delivery amount can be appropriately changed according to the type and administration method of the chemical solution.
  • the liquid feeding unit 100 and the controller 200 separate from the liquid feeding unit 100 are configured, but the configuration is not limited thereto.
  • the liquid feeding unit 100 is configured to combine the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30, but the present invention is not limited thereto.
  • the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30 can be integrated.
  • the chemical liquid administration device 300 has the first control unit 260 and the second control unit 50, but is not limited thereto.
  • the medicinal solution administration device 300 is configured not to include a controller, it is possible to have one control unit.
  • the drug solution (insulin) administered into the living body decreases at a constant rate with respect to the elapsed time.
  • the remaining amount of the chemical solution can be calculated on the assumption that the decreasing rate of the chemical solution changes with time.
  • the second communication unit 40 of the liquid feeding unit 100 has a function capable of wirelessly communicating with other liquid feeding devices, but is not limited thereto.
  • the first communication unit 250 included in the controller 200 may be configured to have a function capable of wirelessly communicating with other liquid delivery devices.
  • the second data can be acquired only by the data input receiving unit (receiving unit 230).
  • the data input reception unit (reception unit 230) is configured to receive the input of the second data from the outside by button input, but is not limited thereto.
  • the data input receiving unit can be configured to be able to receive by touch panel or voice.
  • the first data and the second data include the liquid supply amount at the time of liquid supply and the liquid supply end time, but the present invention is not limited to this.
  • the first and second data may be composed of only the liquid feeding amount.
  • medical solution can be suitably set with the content of 1st data or 2nd data.
  • the insulin pen 400 is used as another liquid delivery device, but the invention is not limited to this.
  • Other liquid delivery devices may be devices other than the liquid delivery unit 100 included in the chemical solution administration device 300 as long as the chemical solution can be administered.
  • the insulin pen 400 is used while the liquid feeding operation by the liquid feeding unit 100 is stopped.
  • the invention is not limited thereto.
  • the insulin pen 400 may be used instead of the bolus mode liquid feeding of the liquid feeding unit 100 during the liquid feeding operation by the liquid feeding unit 100.
  • the liquid delivery end time is used as the previous bolus data, but the present invention is not limited to this.
  • the liquid supply amount and liquid supply end time of the previous bolus data are obtained from the drive signal of the motor 32 provided in the liquid supply unit 100, but the invention is not limited to this.
  • the amount and timing of liquid delivery instructed from the controller 200 can be handled as previous bolus data.
  • Second communication unit 50 second control unit, 51 Data management department, 100 liquid feeding part, 200 controllers, 220 display unit, 230 reception desk, 250 1st communication part, 260 first control unit, 261 arithmetic unit, 262 storage unit, 300 insulin administration device, 400 insulin pen, 450 Third communication unit, 460 third control unit, 470 battery, 500 Insulin administration assembly.

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Abstract

[Problem] To provide a device for administering liquid medicine whereby a liquid medicine can be administered in an appropriate feeding amount to a living body, said feeding amount being determined by taking the remaining amount of the liquid medicine, which has been fed by another liquid feeder, etc. to the living body, into consideration and depending on the remaining amount. [Solution] A device 300 for administering liquid medicine comprises: a liquid feeding part 100 that feeds a liquid medicine to a user's living body; a second control part 50 that controls the feeding operation of the liquid feeding part; a liquid feeding data acquisition part (a second communication part 40 and the second control part 50) that is capable of acquiring first data relating to the feeding amount of the liquid medicine fed by the liquid feeding part to the user's living body and second data relating to the feeding amount of the liquid medicine having been fed by a liquid feeder other than the liquid feeding part to the living body; and a calculation part 261 that calculates the amount of the liquid medicine remaining in the living body on the basis of the first data and/or the second data and then calculates a scheduled feeding amount of the liquid medicine to be administered to the living body on the basis of the remaining amount thereof. The control part controls the operation of the liquid feeding part so that the liquid medicine is fed into the living body in the scheduled feeding amount calculated by the calculation part.

Description

薬液投与装置Chemical solution administration device
 本発明は、生体内に薬液を投与するために使用される薬液投与装置に関する。 The present invention relates to a chemical solution administration device used for administering a chemical solution into a living body.
 インスリンなどの薬液を投与する装置として、投与対象となる使用者(患者や被検者等)の皮膚に装着された状態で薬液を投与する携帯型の薬液投与装置が知られている。 As a device for administering a medical solution such as insulin, a portable chemical solution administration device that administers a chemical solution while being attached to the skin of a user (patient, subject, etc.) to be administered is known.
 携帯型の薬液投与装置を使用して薬液の投与を行う場合、使用者の生活リズム等に合わせて、投与を行う度に時間を空けて、所定の期間の間に複数回の投与を実施することがある。このように複数回に亘って投与を繰り返し行う場合、投与を開始する際に、前回投与した薬液が生体内に残存していることがある。生体内に薬液が残存している状態で、その残存量を何ら考慮せずに薬液の投与を実施してしまうと、生体内に薬液が過剰に投与された状態になってしまう虞がある。 When administering a drug solution using a portable drug solution administration device, a plurality of administrations are performed during a predetermined period of time in accordance with the user's life rhythm, etc. Sometimes. When the administration is repeated a plurality of times as described above, the previously administered drug solution may remain in the living body when the administration is started. If a chemical solution is administered without taking into consideration any residual amount in a state where the chemical solution remains in the living body, there is a possibility that the chemical solution is excessively administered in the living body.
 上記のような問題に対して、下記特許文献1には、薬液の投与量と薬液を投与した時刻に基づいて生体内における薬液の残存量を推定し、推定した残存量を考慮した適切な投与量の薬液を送液し得るように送液動作を実施する薬液投与装置が開示されている。 In order to solve the above problems, the following Patent Document 1 discloses an appropriate administration that estimates the remaining amount of a drug solution in a living body based on the dose of the drug solution and the time when the drug solution is administered, and considers the estimated remaining amount. A chemical solution administration device that performs a liquid feeding operation so that an amount of a chemical solution can be delivered is disclosed.
特表2002-523149号公報JP-T-2002-523149
 携帯型の薬液投与装置の使用者は、例えば、故障やメンテナンスなどによって薬液投与装置を一時的に使用できない場合、所定量の薬液が貯蔵された使い切りの送液器具などを使用して薬液の投与を実施することがある。このような送液器具で薬液の投与を代替した後、携帯型の薬液投与装置を再度使用して薬液の送液を再開する場合は、前述したように、既に投与された薬液が生体内にどの程度残存しているかを考慮したうえで、再開時の薬液の投与量を設定する必要がある。 When a user of a portable chemical solution administration device cannot use the chemical solution administration device temporarily due to, for example, a failure or maintenance, the user can administer the chemical solution using a single-use liquid delivery device in which a predetermined amount of chemical solution is stored. May be implemented. After replacing the administration of the chemical solution with such a liquid delivery device, when the liquid delivery of the chemical solution is resumed by using the portable chemical solution administration device again, as described above, the already administered chemical solution is in the living body. It is necessary to set the dose of the drug solution at the time of resumption after considering how much remains.
 しかしながら、特許文献1に記載された薬液投与装置は、当該薬液投与装置以外の他の送液器具や装置などによって薬液が投与された場合に、その投与された薬液の残存量を推定および把握するようには構成されていない。このため、当該薬液投与装置による薬液の投与を再開する際の投与量には、他の送液器具や装置によって投与された薬液の残存量が反映されることはない。したがって、適切な投与量での薬液の送液が実施されず、例えば、薬液が過剰投与されてしまうなどの問題が発生する可能性がある。 However, the chemical solution administration device described in Patent Document 1 estimates and grasps the remaining amount of the administered chemical solution when the chemical solution is administered by a liquid delivery device or device other than the chemical solution administration device. It is not configured as such. For this reason, the remaining amount of the chemical solution administered by another liquid delivery device or apparatus is not reflected in the dose when the administration of the chemical solution by the chemical solution administration device is resumed. Accordingly, there is a possibility that a chemical solution is not delivered at an appropriate dose, and problems such as excessive administration of the chemical solution may occur.
 そこで本発明は、他の送液器具等によって投与された薬液の生体内における残存量を考慮し、当該残存量に基づいた適切な送液量で薬液の投与を実施し得る薬液投与装置を提供することを目的とする。 Therefore, the present invention provides a chemical solution administration device that can administer a chemical solution with an appropriate liquid delivery amount based on the remaining amount in consideration of the residual amount of the chemical solution administered by another liquid delivery device or the like in the living body. The purpose is to do.
 本発明に係る薬液投与装置は、使用者の生体内へ薬液を送液する送液部と、前記送液部による送液動作を制御する制御部と、前記送液部が前記生体内へ送液した前記薬液の送液量に関する第1データ、および前記送液部以外の他の送液器具が前記生体内へ送液した前記薬液の送液量に関する第2データを取得可能な送液データ取得部と、前記第1データおよび/または前記第2データに基づいて前記生体内における前記薬液の残存量を計算し、かつ、当該薬液の残存量に基づいて前記生体へ投与すべき前記薬液の送液予定量を計算する演算部と、を有しており、前記制御部は、前記送液予定量の前記薬液が前記生体へ送液されるように前記送液部の送液動作を制御することを特徴とする。 The liquid medicine administration device according to the present invention includes a liquid feeding section that feeds a liquid medicine into a user's living body, a control section that controls a liquid feeding operation by the liquid feeding section, and the liquid feeding section that feeds the living body into the living body. Liquid feeding data capable of acquiring first data related to the liquid feeding amount of the liquid chemical and liquid second data relating to the liquid feeding amount of the liquid chemical delivered by the liquid feeding device other than the liquid feeding unit into the living body. Based on the acquisition unit, the first data and / or the second data, the remaining amount of the drug solution in the living body is calculated, and the drug solution to be administered to the living body based on the remaining amount of the drug solution And a calculation unit that calculates a liquid feeding scheduled amount, and the control unit controls a liquid feeding operation of the liquid feeding unit so that the liquid feeding amount of the chemical solution is fed to the living body. It is characterized by doing.
 本発明に係る薬液投与装置によれば、当該薬液投与装置以外の他の送液器具等によって薬液が送液(投与)された場合、その送液量に関するデータを取得し、必要に応じて当該データに基づいて生体内における薬液の残存量を計算し、さらに薬液の残存量に基づいた適正な送液予定量を計算する。そして、制御部により、計算された送液予定量の薬液が送液されるように送液部の動作が制御されるため、他の送液器具等によって薬液の投与が行われたような場合においても、生体内における薬液の残存量を考慮した適切な送液量で薬液を投与することが可能になる。 According to the liquid medicine administration device according to the present invention, when the liquid medicine is delivered (administered) by a liquid delivery device other than the liquid medicine administration apparatus, data relating to the amount of liquid delivery is obtained, and if necessary, Based on the data, the remaining amount of the chemical solution in the living body is calculated, and further, an appropriate liquid delivery amount based on the remaining amount of the chemical solution is calculated. And, since the operation of the liquid feeding part is controlled by the control part so that the calculated liquid feeding amount is calculated, the liquid medicine is administered by another liquid feeding device or the like. In this case, it is possible to administer the drug solution with an appropriate liquid feeding amount in consideration of the remaining amount of the drug solution in the living body.
実施形態に係る薬液投与セットを示す概観図である。It is a general-view figure which shows the chemical | medical solution administration set which concerns on embodiment. 実施形態に係る薬液投与装置が備える送液部の分解斜視図である。It is a disassembled perspective view of the liquid feeding part with which the chemical | medical solution administration apparatus which concerns on embodiment is provided. 図3(A)は、送液部が備える注入部の上面図、図3(B)および図3(C)は、図3(A)の3B-3B線に沿う断面図であって、穿刺具を使用してカニューレを生体内へ導入する際の操作を示す図である。3A is a top view of the injection part provided in the liquid feeding part, and FIGS. 3B and 3C are cross-sectional views taken along the line 3B-3B in FIG. It is a figure which shows operation at the time of introduce | transducing a cannula into a biological body using a tool. 図4(A)は、送液部の各部の構造を簡略的に示す平面図、図4(B)は、図4(A)の4B-4B線に沿う断面図である。4A is a plan view schematically showing the structure of each part of the liquid feeding part, and FIG. 4B is a cross-sectional view taken along line 4B-4B of FIG. 4A. 図5(A)は、実施形態に係る薬液投与装置の送液モードを例示する図、図5(B)は、実施形態に係る生体内に投与した薬液の残存量の時間変化を示す図である。FIG. 5A is a diagram illustrating a liquid feeding mode of the drug solution administration device according to the embodiment, and FIG. 5B is a diagram illustrating a change over time in the remaining amount of the drug solution administered into the living body according to the embodiment. is there. 実施形態に係る薬液投与セットの全体構成を示すブロック図である。It is a block diagram which shows the whole structure of the chemical | medical solution administration set which concerns on embodiment. コントローラが実施する動作処理のフローチャートを示す図である。It is a figure which shows the flowchart of the operation process which a controller implements. 送液部が実施する動作処理のフローチャートを示す図である。It is a figure which shows the flowchart of the operation process which a liquid feeding part implements. 実施形態に係る薬液投与セットが生体内へ送液した薬液の送液量の時間変化を示す図であって、図9(A)は、薬液投与装置によって投与が行われた後、薬液投与装置による投与が再開される場合の例を示す図、図9(B)は、薬液投与装置以外の他の送液器具によって投与が行われた後、薬液投与装置による投与が再開される場合の例を示す図である。FIG. 9A is a diagram showing a change over time in the amount of liquid medicine delivered to the living body by the liquid medicine administration set according to the embodiment, and FIG. 9A shows the state after the administration by the liquid medicine administration apparatus. FIG. 9 (B) is a diagram showing an example of when administration by the chemical solution is resumed, and FIG. 9B shows an example when administration by the chemical solution administration device is resumed after administration by a liquid delivery device other than the chemical solution administration device FIG. 実施形態の変形例に係る薬液投与セットが生体内へ送液した薬液の送液量の時間変化を示す図である。It is a figure which shows the time change of the liquid feeding amount of the chemical | medical solution which the chemical | medical solution administration set which concerns on the modification of embodiment delivered to the biological body.
 以下、添付した図面を参照しながら、本願発明に係る実施形態を説明する。図面における各部材の大きさや比率は、説明の都合上誇張され実際の大きさや比率とは異なる場合がある。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. The size and ratio of each member in the drawings are exaggerated for convenience of explanation and may be different from the actual size and ratio.
 図1は、実施形態に係る薬液投与セットの各部の構成の説明に供する図であり、図2~図4は、実施形態に係る薬液投与装置の各部の構成の説明に供する図であり、図5は、薬液投与装置の送液モードと薬液の残存量の時間変化との関係を示す図であり、図6は、薬液投与セットの全体構成を示すブロック図であり、図7~図9は、コントローラが備える第1制御部および送液部が備える第2制御部の動作処理例を示す図である。 FIG. 1 is a diagram for explaining the configuration of each part of the drug solution administration set according to the embodiment, and FIGS. 2 to 4 are diagrams for explaining the configuration of each part of the drug solution administration device according to the embodiment. FIG. 5 is a diagram showing the relationship between the liquid delivery mode of the drug solution administration device and the change over time of the remaining amount of the drug solution, FIG. 6 is a block diagram showing the overall configuration of the drug solution administration set, and FIGS. It is a figure which shows the operation processing example of the 1st control part with which a controller is provided, and the 2nd control part with which a liquid feeding part is provided.
 本実施形態に係る薬液投与セット500は、使用者である糖尿病患者の生体内へ薬液としてのインスリンを送液するインスリン投与装置として構成している。 The medicinal solution administration set 500 according to the present embodiment is configured as an insulin administration device that delivers insulin as a medicinal solution into a living body of a diabetic patient who is a user.
 図1に示すように、薬液投与セット500は、身体に装着可能な携帯型の薬液投与装置300と、ペン型のインスリン投与器具として構成されたインスリンペン(他の送液器具に相当する)400と、を有している。なお、以下の説明では、薬液投与装置300をインスリン投与装置300と称する。 As shown in FIG. 1, a medicinal solution administration set 500 includes a portable medicinal solution administration device 300 that can be worn on the body, and an insulin pen (corresponding to another liquid delivery device) 400 configured as a pen-type insulin administration device. And have. In the following description, the drug solution administration device 300 is referred to as an insulin administration device 300.
 まず、薬液投与セット500の動作の概要について説明する。 First, an outline of the operation of the drug solution administration set 500 will be described.
 図5(A)に示すように、薬液投与セット500が備えるインスリン投与装置300は、インスリンを一定量で経時的に送液するベーサルモードでの送液(図中のM1)と、単位時間当たりのインスリンの送液量を一時的に増加して送液するボーラスモードでの送液(図中のM2)を使用者の指示に応じて実施可能に構成されている。一般的に、血糖値を上昇させる行動(例えば、食事の摂取)を行う直前または直後にボーラスモードでの送液が実施される。また、通常時は血糖値の上限値および下限値が所定の範囲内で安定して維持されるようにベーサルモードでの送液が実施される。 As shown in FIG. 5 (A), the insulin administration device 300 provided in the medicinal solution administration set 500 includes a liquid supply (M1 in the figure) in a basal mode in which a constant amount of insulin is supplied over time, and per unit time. The liquid supply amount (M2 in the figure) in the bolus mode in which the liquid supply amount of insulin is temporarily increased to be supplied is configured in accordance with the user's instruction. In general, liquid feeding in a bolus mode is performed immediately before or immediately after performing an action (for example, ingestion of a meal) that increases a blood glucose level. Further, during normal times, the liquid supply in the basal mode is performed so that the upper limit value and the lower limit value of the blood sugar level are stably maintained within a predetermined range.
 使用者は、通常は、インスリン投与装置300を使用してベーサルモードおよび定期的なボーラスモードにおけるインスリンの投与を行う。インスリン投与装置300は、多量のインスリンが投与されるボーラスモードにおける送液を行う場合、前回のボーラスモードにおいて送液部100が送液したインスリンの送液量に関するデータ(以下「第1データ」と称する)に基づいて生体内に残存するインスリンの量(以下、「残存インスリン量」と称する)を推定し、当該残存インスリン量に基づいて送液予定量を計算するように構成されている。 The user normally administers insulin in the basal mode and the regular bolus mode using the insulin administration device 300. When the insulin administration apparatus 300 performs liquid feeding in a bolus mode in which a large amount of insulin is administered, data related to the amount of insulin delivered by the liquid feeding unit 100 in the previous bolus mode (hereinafter referred to as “first data”). The amount of insulin remaining in the living body (hereinafter referred to as “residual insulin amount”) is estimated on the basis of the residual insulin amount, and the liquid delivery scheduled amount is calculated based on the residual insulin amount.
 しかし、故障やメンテナンス等のためにインスリン投与装置300を使用することができない場合、インスリン投与装置300のボーラスモードにおけるインスリンの投与に替えて、インスリンペン400を適宜使用して規定量のインスリンの投与を行う場合がある。このような場合、インスリンペン400は、当該インスリンペン400が送液した送液量に関するデータ(以下「第2データ」と称する)をインスリン投与装置300に送信するように構成されている。そして、再びインスリン投与装置300を用いてボーラスモードにおけるインスリンの投与を行う場合、インスリン投与装置300は、前述の第1データに替えてインスリンペン400から受信した第2データを用いて残存インスリン量を計算するように構成されている。 However, when the insulin administration device 300 cannot be used due to malfunction or maintenance, the insulin pen 400 is appropriately used instead of the insulin administration in the bolus mode of the insulin administration device 300 to administer the prescribed amount of insulin. May do. In such a case, the insulin pen 400 is configured to transmit data (hereinafter referred to as “second data”) relating to the amount of liquid delivered by the insulin pen 400 to the insulin administration device 300. Then, when insulin is administered again in the bolus mode using the insulin administration device 300, the insulin administration device 300 uses the second data received from the insulin pen 400 in place of the first data to determine the remaining insulin amount. Configured to calculate.
 図9を参照して、インスリン投与装置300の残存インスリン量の計算例を説明する。 Referring to FIG. 9, a calculation example of the residual insulin amount of the insulin administration device 300 will be described.
 図9(A)は、インスリン投与装置300によってボーラスモードにおける送液が2回行われる状態を示す。この場合、インスリン投与装置300は、1回目のボーラスモードにおける送液量V等を含む第1データに基づいてインスリン残存量を計算し、当該インスリン残存量に基づいて2回目の送液予定量Vを計算する。 FIG. 9A shows a state in which the insulin administration apparatus 300 performs liquid feeding twice in the bolus mode. In this case, the insulin administration device 300 calculates the remaining amount of insulin based on the first data including the amount of liquid delivery V 0 in the first bolus mode, and the second amount of liquid delivery scheduled for the second time based on the amount of remaining insulin. V n is calculated.
 これに対して、図9(B)は、まず規定量Vのインスリンの投与がインスリンペン400によって行われ、その後インスリン投与装置300を用いてボーラスモードにおける送液が行われる状態を示す。この場合、インスリン投与装置300は、インスリンペン400によって送液されたインスリンの送液量Vを含む第2データに基づいてインスリン残存量を計算し、当該インスリン残存量に基づいてボーラスモードにおける送液予定量Vを計算する。 On the other hand, FIG. 9B shows a state in which the insulin of the specified amount V 0 is first administered by the insulin pen 400 and then the liquid is fed in the bolus mode using the insulin administration device 300. In this case, the insulin administration device 300 calculates the residual insulin amount based on the second data including the liquid delivery amount V 0 of the insulin delivered by the insulin pen 400, and based on the insulin residual amount, the insulin delivery device 300 delivers the insulin in the bolus mode. to calculate the liquid predetermined amount V n.
 このように、薬液投与セット500では、インスリン投与装置300およびインスリンペン400を併用した際においても、残存インスリン量に基づいた適切な送液予定量の薬液を送液することが可能になっている。 As described above, in the medicinal solution administration set 500, even when the insulin administration device 300 and the insulin pen 400 are used in combination, it is possible to deliver an appropriate amount of medicinal solution based on the residual insulin amount. .
 次に、薬液投与セット500の各構成について説明する。 Next, each component of the chemical solution administration set 500 will be described.
 まず、インスリン投与装置300について説明する。 First, the insulin administration device 300 will be described.
 図1に示すように、インスリン投与装置300は、薬液であるインスリンを生体内へ送液する送液動作を行う送液部100と、送液部100に対して各種の動作指示を行うコントローラ200と、を備えている。 As shown in FIG. 1, an insulin administration device 300 includes a liquid feeding unit 100 that performs a liquid feeding operation for feeding insulin, which is a drug solution, into a living body, and a controller 200 that instructs the liquid feeding unit 100 to perform various operations. And.
 コントローラ200は、使用者からの指示内容を受け付け可能な受付部230を備えており、指示内容に基づいて所定量のインスリン(以下、「送液予定量のインスリン」とする)を送液すべき旨の送液指示を送液部100へ送信する。使用者は、自身の身体に送液部100を取り付けた状態で、送液部100とは別体のコントローラ200を操作することによって、送液部100に送液指示を行うことが可能になっている。 The controller 200 includes a receiving unit 230 that can receive the instruction content from the user, and should deliver a predetermined amount of insulin (hereinafter referred to as “scheduled amount of insulin”) based on the instruction content. A liquid delivery instruction to that effect is transmitted to the liquid delivery unit 100. The user can give a liquid feeding instruction to the liquid feeding unit 100 by operating the controller 200 separate from the liquid feeding unit 100 in a state where the liquid feeding unit 100 is attached to his / her body. ing.
 送液部100について説明する。 The liquid delivery unit 100 will be described.
 図2に示すように、送液部100は、使用者の身体に取り付けられ、使用者の生体内に留置するカニューレ11などを備える注入部10と、注入部10に連結・分離可能に構成され、インスリンが充填されたシリンジ22などを備える使い捨て可能な送液ディスポ部20と、送液ディスポ部20に連結・分離可能に構成され、送液動作を駆動する駆動部35などを備える再利用可能な送液リユース部30と、を有している。 As shown in FIG. 2, the liquid feeding unit 100 is attached to a user's body and configured to be connected to and separated from the injection unit 10 including a cannula 11 and the like placed in the user's body. , A disposable liquid feeding disposable unit 20 including a syringe 22 filled with insulin, and a reusable unit configured to be connected to and separated from the liquid feeding disposable unit 20 and driving a liquid feeding operation. And a liquid feed reuse unit 30.
 インスリン投与装置300は、送液ディスポ部20が備えるシリンジ22内のインスリンが空になった場合などは、送液ディスポ部20を必要に応じて新しいものに交換することによって繰り返し使用することが可能なリユース性を備えている。 The insulin administration device 300 can be used repeatedly by replacing the liquid delivery disposable unit 20 with a new one as necessary when the insulin in the syringe 22 provided in the liquid delivery disposable unit 20 becomes empty. Reusability is provided.
 注入部10について説明する。 The injection unit 10 will be described.
 図2に示すように、注入部10は、カニューレ11と、カニューレ11を支持する支持部材12と、平板状の載置部13aおよび載置部13aの外周縁部の一部から突設した縦壁部13bを備える注入部保持部材(クレードル)13と、注入部保持部材13の裏面側に設けられ、注入部10を使用者の身体に貼り付ける貼付部14と、を有している。 As shown in FIG. 2, the injection part 10 has a cannula 11, a support member 12 that supports the cannula 11, a flat plate-like placement part 13 a, and a vertical projection that protrudes from a part of the outer peripheral edge of the placement part 13 a. The injection part holding member (cradle) 13 provided with the wall part 13b, and the sticking part 14 which is provided in the back surface side of the injection part holding member 13, and affixes the injection part 10 to a user's body.
 注入部保持部材13には、送液ディスポ部20との機械的な連結状態を維持するための係合部(図示省略)を設けている。この係合部は、例えば、送液ディスポ部20側に形成される突起や窪み等と嵌合自在な突起や窪みなどによって構成することが可能である。図3(B)、図3(C)に示すように、注入部保持部材13の載置部13aには、カニューレ11を挿通可能な挿通穴13cを設けている。 The injection part holding member 13 is provided with an engaging part (not shown) for maintaining a mechanically connected state with the liquid delivery disposable part 20. This engaging part can be constituted by, for example, a protrusion or a depression that can be fitted to a protrusion or a depression formed on the liquid feeding disposable part 20 side. As shown in FIGS. 3B and 3C, the mounting portion 13 a of the injection portion holding member 13 is provided with an insertion hole 13 c through which the cannula 11 can be inserted.
 図2に示すように、支持部材12は、略円柱形状に形成された本体部12aを有している。また、本体部12aには、送液ディスポ部20が備える送液管23(図4(B)を参照)が連結される連結部12bが設けられている。 As shown in FIG. 2, the support member 12 has a main body 12a formed in a substantially cylindrical shape. The main body portion 12a is provided with a connecting portion 12b to which a liquid feeding pipe 23 (see FIG. 4B) provided in the liquid feeding disposable portion 20 is coupled.
 図3(B)、図3(C)に示すように、カニューレ11は、本体部12aの底面から突出自在に構成している。本体部12a内には、カニューレ11を本体部12aから突出させた際に、連結部12bとカニューレ11の内部流路(ルーメン)とを連通させる流路12cを設けている。なお、図3(B)、図3(C)は、本体部12aからカニューレ11を突出させる前後の様子を簡略的に示している。 3B and 3C, the cannula 11 is configured to protrude from the bottom surface of the main body 12a. A flow path 12c is provided in the main body 12a to allow the connecting portion 12b to communicate with the internal flow path (lumen) of the cannula 11 when the cannula 11 protrudes from the main body 12a. 3 (B) and 3 (C) simply show the state before and after the cannula 11 is projected from the main body portion 12a.
 貼付部14は、略矩形状のシート状の部材により構成している。貼付部14は、注入部保持部材13の裏面に向かい合わせて配置される側の面と反対側の面(裏面)に接着性が付加されている。貼付部14の接着性を利用して、使用者の身体に注入部10を貼り付けることができる。なお、貼付部14を覆って保護する取り外し可能な剥離紙などを使用して、貼付部14が不用意に貼り付けられるのを防止するようにしてもよい。 The pasting part 14 is comprised by the substantially rectangular sheet-like member. Adhesiveness is added to the surface (back surface) of the sticking portion 14 opposite to the surface disposed facing the back surface of the injection portion holding member 13. The injection part 10 can be affixed to a user's body using the adhesiveness of the affixing part 14. A removable release paper that covers and protects the sticking portion 14 may be used to prevent the sticking portion 14 from being inadvertently stuck.
 支持部材12の本体部12aに収納したカニューレ11を使用者の生体内に導入させる際の操作例を説明する。 An example of operation when the cannula 11 housed in the main body 12a of the support member 12 is introduced into the user's body will be described.
 インスリン投与装置300を使用する際、使用者は、貼付部14を介して注入部10を自身の身体(皮膚表面)に貼り付ける。この時点では、カニューレ11は本体部12a内に収容された状態にある。カニューレ11は、生体への導入に使用される専用の器具である穿刺具15を用いることによって、本体部12aから使用者の生体内へ向けて突出させる。 When using the insulin administration device 300, the user sticks the injection part 10 to his body (skin surface) via the sticking part 14. At this time, the cannula 11 is in a state of being accommodated in the main body 12a. The cannula 11 is protruded from the main body portion 12a toward the user's living body by using a puncture tool 15 which is a dedicated instrument used for introduction into the living body.
 図2、図3(B)に示すように、穿刺具15は、使用者が手指で把持することが可能な把持部15aと、鋭利な針先を備える穿刺針15bと、を有している。穿刺具15が未使用の状態においては、穿刺針15bは、把持部15aの内部に収納される。 As shown in FIGS. 2 and 3B, the puncture device 15 includes a gripping portion 15a that can be gripped by a user with a finger, and a puncture needle 15b having a sharp needle tip. . When the puncture device 15 is not used, the puncture needle 15b is housed inside the grip portion 15a.
 図3(B)に示すように、本体部12aの上面部分に穿刺具15を装着した状態とし、穿刺具15を本体部12aに対して回転させると、図3(C)に示すように穿刺針15bがカニューレ11のルーメンを挿通して、カニューレ11とともに本体部12aの下面側(裏面側)から突出する。 As shown in FIG. 3B, when the puncture device 15 is attached to the upper surface portion of the main body 12a and the puncture device 15 is rotated with respect to the main body 12a, the puncture is performed as shown in FIG. The needle 15b passes through the lumen of the cannula 11, and protrudes from the lower surface side (back surface side) of the main body 12a together with the cannula 11.
 穿刺針15bおよびカニューレ11において本体部12aから突出した部分は、生体の表皮を貫通して生体内へ導入される。穿刺針15bおよびカニューレ11が生体内に導入されたのを確認した後、把持部15aを持ち上げて、穿刺針15bをカニューレ11から抜去する。この操作により、カニューレ11は、穿刺針15bが抜去された状態で、生体内に留置される(図4(B)参照)。 The portions of the puncture needle 15b and the cannula 11 that protrude from the main body 12a penetrate through the epidermis of the living body and are introduced into the living body. After confirming that the puncture needle 15b and the cannula 11 have been introduced into the living body, the grasping portion 15a is lifted and the puncture needle 15b is removed from the cannula 11. By this operation, the cannula 11 is placed in the living body with the puncture needle 15b removed (see FIG. 4B).
 図2に示すように、穿刺具15を取り外すことにより、送液ディスポ部20および送液リユース部30を注入部10に取付けることが可能になる。なお、本体部12aの上面部分には、穿刺針15bを取り外した後においても、外部とのシール性が確保されるように、穿刺針15bが挿通される部位に弾性材料等からなるシール材12dを設置している。 As shown in FIG. 2, by removing the puncture tool 15, the liquid feeding disposable part 20 and the liquid feeding reuse part 30 can be attached to the injection part 10. It should be noted that a sealing material 12d made of an elastic material or the like is inserted into a portion through which the puncture needle 15b is inserted in the upper surface portion of the main body portion 12a so that the sealing performance with the outside is ensured even after the puncture needle 15b is removed. Is installed.
 次に、送液ディスポ部20および送液リユース部30について説明する。なお、図4(A)には、注入部10、送液ディスポ部20、および送液リユース部30を連結させた状態の送液部100を示している。破線Xで囲まれた部分は、送液ディスポ部20内に収納されており、破線Yで囲まれた部分は、送液リユース部30内に収納されている。 Next, the liquid feeding disposable unit 20 and the liquid feeding reuse unit 30 will be described. 4A shows the liquid feeding unit 100 in a state where the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30 are connected. The portion surrounded by the broken line X is housed in the liquid feeding disposable unit 20, and the portion surrounded by the broken line Y is housed in the liquid feeding reuse unit 30.
 図2、図4(A)に示すように、送液ディスポ部20は、注入部保持部材13上に載置される送液ディスポ部保持部材21と、インスリンが充填されたシリンジ22と、注入部10に設けた連結部12bとシリンジ22とを連通させる送液管23と、を有している。 As shown in FIG. 2 and FIG. 4 (A), the liquid delivery disposable part 20 includes a liquid delivery disposable part holding member 21 placed on the injection part holding member 13, a syringe 22 filled with insulin, and an injection. And a liquid feeding pipe 23 that communicates the connecting part 12b provided in the part 10 with the syringe 22.
 送液ディスポ部20は、さらに、シリンジ22内を摺動して当該シリンジ22内のインスリンを送液管23に送液する押し子24と、押し子24に形成された雌ねじ部24dと噛合って押し子24をシリンジ22内へ送り込む送りねじ25と、送りねじ25に送液リユース部30の駆動部35からの回転力を伝える歯車26と、駆動部35などに電力を供給する電池27と、を有している。 The liquid feeding disposable part 20 further meshes with a pusher 24 that slides in the syringe 22 and feeds the insulin in the syringe 22 to the liquid feeding pipe 23, and a female screw part 24 d formed on the pusher 24. A feed screw 25 that feeds the pusher 24 into the syringe 22, a gear 26 that transmits the rotational force from the drive unit 35 of the liquid-feed reuse unit 30 to the feed screw 25, and a battery 27 that supplies power to the drive unit 35, etc. ,have.
 図4(A)に示すように、押し子24は、シール性を保ちつつシリンジ22内を摺動する押し板24aと、雌ねじ部24dを有する送り板24bと、押し板24aおよび送り板24bに連接する連結板24cと、を有している。 As shown in FIG. 4A, the pusher 24 includes a push plate 24a that slides inside the syringe 22 while maintaining a sealing property, a feed plate 24b having an internal thread portion 24d, and the push plate 24a and the feed plate 24b. And a connecting plate 24c connected to each other.
 送りねじ25は、その一部が送り板24bの雌ねじ部24dに噛み合わされる。また、送りねじ25の基端部は、歯車26に固定されている。送りねじ25が歯車26の回転に伴って回転すると、送り板24bが送りねじ25上を移動する。連結板24cを介して送り板24bに連接された押し板24aは、送り板24bの移動に伴ってシリンジ22内を摺動する。 A part of the feed screw 25 is meshed with the female screw portion 24d of the feed plate 24b. Further, the base end portion of the feed screw 25 is fixed to the gear 26. When the feed screw 25 rotates with the rotation of the gear 26, the feed plate 24 b moves on the feed screw 25. The push plate 24a connected to the feed plate 24b via the connecting plate 24c slides in the syringe 22 as the feed plate 24b moves.
 送液管23は、シリンジ22の内部とカニューレ11の連結部12bとを液密に連通させる金属製の細管により構成している。図2に示すように、送液ディスポ部保持部材21を注入部保持部材13にスライドさせながら連結させると、図4(B)に示すように、送液管23の先端が注入部10の連結部12b内に差し込まれる。連結部12bの送液管23が差し込まれる部位には弾性部材等からなる不図示のシール材を設置し、これにより、連結部12bと送液管23とを液密に連結することができる。 The liquid feeding tube 23 is constituted by a thin metal tube that fluidly communicates the inside of the syringe 22 and the connecting portion 12b of the cannula 11 with each other. As shown in FIG. 2, when the liquid delivery disposable holding member 21 is connected to the injection part holding member 13 while being slid, the tip of the liquid delivery pipe 23 is connected to the injection part 10 as shown in FIG. It is inserted into the part 12b. A sealing material (not shown) made of an elastic member or the like is installed at a portion of the connecting portion 12b into which the liquid feeding pipe 23 is inserted, whereby the connecting portion 12b and the liquid feeding pipe 23 can be liquid-tightly connected.
 電池27は、送液ディスポ部20を送液リユース部30に連結させる際に、送液リユース部30内の駆動部35(モータ32)に電気的に接続される。これにより、電池27から駆動部35へ電力を供給することが可能になる。また、電池27は、送液リユース部30に収納されている第2通信部40、第2制御部50にも電気的に接続されており、それぞれに対して電力を供給する。 The battery 27 is electrically connected to the drive unit 35 (motor 32) in the liquid feeding reuse unit 30 when the liquid feeding disposable unit 20 is connected to the liquid feeding reuse unit 30. As a result, power can be supplied from the battery 27 to the drive unit 35. The battery 27 is also electrically connected to the second communication unit 40 and the second control unit 50 housed in the liquid feeding and reuse unit 30, and supplies power to each of them.
 図2、図4(A)に示すように、送液リユース部30は、送液ディスポ部保持部材21に連結される送液リユース部保持部材31と、電池27に電気的に接続されるモータ32と、モータ32により回転駆動される回転軸33と、回転軸33の回転を送りねじ25に伝達する複数の歯車34と、を有している。なお、送液部100の送液動作を駆動する駆動部35は、モータ32、回転軸33、および歯車34によって構成している。 As shown in FIG. 2 and FIG. 4A, the liquid feeding reuse unit 30 includes a liquid feeding reuse part holding member 31 coupled to the liquid feeding disposable holding member 21 and a motor electrically connected to the battery 27. 32, a rotation shaft 33 that is rotationally driven by the motor 32, and a plurality of gears 34 that transmit the rotation of the rotation shaft 33 to the feed screw 25. The driving unit 35 that drives the liquid feeding operation of the liquid feeding unit 100 includes a motor 32, a rotating shaft 33, and a gear 34.
 図2に示すように、送液リユース部保持部材31は、送液ディスポ部保持部材21を覆うケース(筐体)として構成している。送液ディスポ部保持部材21の内部には、上述した送液リユース部30の各構成部材を収納している。 As shown in FIG. 2, the liquid feeding reuse portion holding member 31 is configured as a case (casing) that covers the liquid feeding disposable portion holding member 21. Each component of the liquid feeding reuse unit 30 described above is accommodated in the liquid feeding disposable holding member 21.
 図4(A)に示すように、モータ32は、送液リユース部30を送液ディスポ部20に連結させた際に、送液ディスポ部20の電池27に電気的に接続可能な位置に配置される。複数の歯車34には、モータ32の回転軸33に連結される第1の歯車と、送液ディスポ部20が備える歯車26に噛み合わされる第2の歯車と、第1および第2の歯車の間に配置され、各歯車と噛み合わされる第3の歯車とが含まれている。なお、本実施形態では簡易的に歯車34は、第1および第2の2つの歯車により構成されたものを例示している。 As shown in FIG. 4 (A), the motor 32 is arranged at a position where it can be electrically connected to the battery 27 of the liquid delivery disposable part 20 when the liquid delivery reuse part 30 is connected to the liquid delivery disposable part 20. Is done. The plurality of gears 34 include a first gear coupled to the rotation shaft 33 of the motor 32, a second gear meshed with the gear 26 provided in the liquid delivery disposable unit 20, and the first and second gears. A third gear disposed between and meshed with each gear is included. In the present embodiment, the gear 34 is simply constituted by a first gear and a second gear.
 使用者は、インスリン投与装置300を使用するに際して、まず、送液ディスポ部20と送液リユース部30とを連結して一体化させる。そして、カニューレ11が生体内に留置された状態で使用者の身体に装着された注入部10に対して、一体化させた送液ディスポ部20および送液リユース部30を連結させる。 When using the insulin administration device 300, the user first connects and integrates the liquid feeding disposable unit 20 and the liquid feeding reuse unit 30. And the liquid feeding disposable part 20 and the liquid feeding reuse part 30 which were integrated are connected with respect to the injection | pouring part 10 with which the cannula 11 was detained in the living body with which the user's body was mounted | worn.
 また、使用者は、一体化された送液ディスポ部20および送液リユース部30を注入部10に対して連結させる前に、送液ディスポ部20の送液管23内にインスリンを充填するプライミングを行う。具体的には、駆動部35を動作させて、押し子24を所定量だけ移動させることにより、シリンジ22内に収容されたインスリンを送液管23に送液し、送液管23内にインスリンを充填させる。 In addition, the user performs priming for filling insulin in the liquid feeding tube 23 of the liquid feeding disposable part 20 before connecting the integrated liquid feeding disposable part 20 and the liquid feeding reuse part 30 to the injection part 10. I do. Specifically, by operating the drive unit 35 and moving the pusher 24 by a predetermined amount, the insulin accommodated in the syringe 22 is fed to the liquid feeding tube 23, and the insulin is fed into the liquid feeding tube 23. To fill.
 次に、コントローラ200について説明する。 Next, the controller 200 will be described.
 図1に示すように、コントローラ200は、コントローラ本体部210と、コントローラ本体部210に設けられる表示部220と、使用者からの指示内容を受付可能な受付部230と、コントローラ200の各部に電力を供給する電源部240と、を有している。 As illustrated in FIG. 1, the controller 200 includes a controller main body 210, a display unit 220 provided in the controller main body 210, a reception unit 230 that can receive instructions from a user, and power to each unit of the controller 200. And a power supply unit 240 for supplying power.
 表示部220は、例えば、液晶ディスプレイにより構成することができる。表示部220には、使用者がインスリン投与装置300の操作に必要な情報や、送液動作の進行状況などを表示することが可能になっている。 The display unit 220 can be configured by a liquid crystal display, for example. The display unit 220 can display information necessary for the user to operate the insulin administration device 300, the progress of the liquid feeding operation, and the like.
 受付部230は、複数のボタンを有しており、ボタン操作によって使用者からの指示内容を受け付ける。受付部230には、例えば、ベーサルモード、ボーラスモード、およびプライミング動作などを選択するためのボタンや、表示部220の表示内容を切り替えるボタンなどが備えられる。使用者が目的に応じてこれらのボタンを選択して押すことにより、送液指示の送信、送液モードの選択、各種の動作の指定などを行うことが可能になっている。 The receiving unit 230 has a plurality of buttons, and receives instruction contents from the user by button operation. The accepting unit 230 includes, for example, a button for selecting a basal mode, a bolus mode, a priming operation, and the like, a button for switching display contents of the display unit 220, and the like. When the user selects and pushes these buttons according to the purpose, it is possible to transmit a liquid feeding instruction, select a liquid feeding mode, specify various operations, and the like.
 次に、図1、図2を参照して、コントローラ200、送液部100の制御系統および通信機能について説明する。 Next, the control system and communication function of the controller 200 and the liquid feeding unit 100 will be described with reference to FIGS.
 コントローラ200は、送液部100と無線通信可能な第1通信部250と、インスリン投与装置300を統括して制御する第1制御部260と、を有している。 The controller 200 includes a first communication unit 250 that can wirelessly communicate with the liquid feeding unit 100 and a first control unit 260 that controls the insulin administration device 300 in an integrated manner.
 送液部100の送液リユース部30は、コントローラ200およびインスリンペン400と無線通信可能な第2通信部40と、第1制御部260の指示を受けて送液部100の動作を統括して制御する第2制御部50と、を有している。 The liquid feeding reuse unit 30 of the liquid feeding unit 100 supervises the operation of the liquid feeding unit 100 in response to an instruction from the first control unit 260 and the second communication unit 40 that can wirelessly communicate with the controller 200 and the insulin pen 400. And a second control unit 50 to be controlled.
 コントローラ200の第1通信部250および送液部100の第2通信部40は、低電力で通信を行うことが可能な近距離無線通信技術であるBLE(Bluetooth Low Energy)通信を用いて、互いに情報の送受信を行うことが可能になっている。 The first communication unit 250 of the controller 200 and the second communication unit 40 of the liquid feeding unit 100 use BLE (Bluetooth Low Energy) communication, which is a short-range wireless communication technology capable of performing communication with low power, to each other. It is possible to send and receive information.
 さらに、送液部100の第2通信部40は、後述するインスリンペン400の第3通信部450から送信された第2データを無線通信機能によって取得するデータ取得部としての機能も有する。 Furthermore, the second communication unit 40 of the liquid feeding unit 100 also has a function as a data acquisition unit that acquires second data transmitted from a third communication unit 450 of the insulin pen 400 described later by a wireless communication function.
 コントローラ200の第1制御部260および送液部100の第2制御部50は、CPU、RAM、ROM等を含む公知のマイクロコンピュータにより構成している。第1制御部260および第2制御部50がそれぞれ備えるCPUがROMに予め格納されている各種プログラムをそれぞれRAMに読み出して実行することにより、後述する所定の動作制御が実施される。 The first control unit 260 of the controller 200 and the second control unit 50 of the liquid feeding unit 100 are configured by a known microcomputer including a CPU, a RAM, a ROM, and the like. The CPU included in each of the first control unit 260 and the second control unit 50 reads various programs stored in advance in the ROM into the RAM and executes them, thereby performing predetermined operation control described later.
 次に、インスリンペン400について説明する。 Next, the insulin pen 400 will be described.
 図1に示すように、インスリンペン400は、ペン型の本体部410と、本体部410の先端に設けられた注入針420と、本体部410の内部に収納されており、インスリンが充填されているシリンジ430と、シリンジ430内のインスリンを注入針420から吐出させる注入ボタン440と、を有している。さらにインスリンペン400は、インスリン投与装置300の送液部100と無線通信可能な第3通信部450と、インスリンペン400の動作を統括して制御する第3制御部460と、当該インスリンペン400の各部に電力を供給する電池470と、を有している。 As shown in FIG. 1, an insulin pen 400 is housed in a pen-shaped main body 410, an injection needle 420 provided at the tip of the main body 410, and the main body 410, and is filled with insulin. A syringe 430, and an injection button 440 for discharging the insulin in the syringe 430 from the injection needle 420. Furthermore, the insulin pen 400 includes a third communication unit 450 that can wirelessly communicate with the liquid feeding unit 100 of the insulin administration device 300, a third control unit 460 that performs overall control of the operation of the insulin pen 400, and the insulin pen 400. And a battery 470 for supplying power to each unit.
 第3通信部450は、BLE(Bluetooth Low Energy)通信を用いて、送液部100の備える第2通信部40と互いに情報の送受信を行うことが可能になっている。 The 3rd communication part 450 can transmit / receive information mutually with the 2nd communication part 40 with which the liquid feeding part 100 is provided using BLE (Bluetooth Low Energy) communication.
 第3制御部460は、CPU、RAM、ROM等を含む公知のマイクロコンピュータにより構成している。第3制御部460が備えるCPUがROMに予め格納されている各種プログラムをそれぞれRAMに読み出して実行することにより、後述する所定の動作制御が実施される。 The third control unit 460 is configured by a known microcomputer including a CPU, RAM, ROM, and the like. The CPU included in the third control unit 460 reads various programs stored in advance in the ROM into the RAM and executes them to execute predetermined operation control described later.
 使用者は、インスリンペン400を使用する際は注入針420を身体に穿刺し、注入ボタン440を押して、シリンジ430に充填されているインスリンを生体内に送液する。 When using the insulin pen 400, the user punctures the body with the injection needle 420, presses the injection button 440, and feeds the insulin filled in the syringe 430 into the living body.
 次に、薬液投与セット500の機能について説明する。 Next, the function of the chemical solution administration set 500 will be described.
 薬液投与セット500のインスリン投与装置300は、ボーラスモード時のインスリンの送液予定量を下記の式1に基づいて計算する。 The insulin administration device 300 of the medicinal solution administration set 500 calculates the expected amount of insulin to be delivered in the bolus mode based on the following equation 1.
Figure JPOXMLDOC01-appb-M000001
Figure JPOXMLDOC01-appb-M000001
 上記の式1において、炭水化物量[g]は、使用者がボーラスモードでの送液を開始する直前の食事において摂取した炭水化物の量である。インスリン炭水化物比[g/単位]は、1gの炭水化物を処理できるインスリンの量であり、使用者ごとに定められる所定の値である。測定血糖値[mg/dL]は、食事を摂取する前に測定した血糖値である。目標血糖値[mg/dL]は、インスリンの投与によって調整する目標となる血糖値である。インスリン効果値[mg/dL/単位]は、1単位のインスリンを投与した際に低下する血糖値であり、使用者ごとに定められる所定の値である。 In the above formula 1, the amount of carbohydrate [g] is the amount of carbohydrate ingested in the meal immediately before the user starts feeding in the bolus mode. The insulin carbohydrate ratio [g / unit] is an amount of insulin that can process 1 g of carbohydrate, and is a predetermined value determined for each user. The measured blood glucose level [mg / dL] is a blood glucose level measured before taking a meal. The target blood glucose level [mg / dL] is a target blood glucose level to be adjusted by administration of insulin. The insulin effect value [mg / dL / unit] is a blood glucose level that decreases when one unit of insulin is administered, and is a predetermined value determined for each user.
 上記の式1において残存インスリン量[単位]は、前回のボーラスモードにおける送液時に(以下、「前回ボーラス時」と称する)生体内に投与され、残存しているインスリンの量である。図5(B)を参照して残存インスリン量について説明する。 In the above formula 1, the residual insulin amount [unit] is the amount of insulin that is administered into the living body when the liquid is fed in the previous bolus mode (hereinafter referred to as “previous bolus time”). The remaining insulin amount will be described with reference to FIG.
 図5(B)は、縦軸が残存インスリン量、横軸が前回ボーラス時からの経過時間であり、生体内に投与されたインスリンが時間の経過とともに消費されて減少する様子を示している。図示するように、前回ボーラス時に投与したインスリンの量Vは、時間の経過とともに所定の割合で減少していき、前回ボーラス時からΔtの時間が経過するとVに減少する。このように、残存インスリン量は、前回ボーラス時からの経過時間と、前回投与したインスリン量に基づいて推定することができる。本実施形態では、残存インスリン量は、残存インスリン量と前回ボーラス時からの経過時間との関係を表す所定の式(以下、「残存インスリン関係式」と称する)に基づいて求める。なお、説明を簡易的にするために、図5(B)に示すように生体内に投与されたインスリンは時間の経過とともに一定の割合で減少していくものとする。このため、残存インスリン関係式は、一次関数となる。 In FIG. 5B, the vertical axis represents the amount of residual insulin, the horizontal axis represents the elapsed time from the previous bolus, and the state where the insulin administered into the living body is consumed and decreased with the passage of time is shown. As shown in the figure, the amount V 0 of insulin administered at the previous bolus decreases at a predetermined rate with the passage of time, and decreases to V t when Δt has elapsed from the previous bolus. Thus, the residual insulin amount can be estimated based on the elapsed time from the previous bolus and the previously administered insulin amount. In the present embodiment, the residual insulin amount is obtained based on a predetermined expression (hereinafter referred to as “residual insulin relational expression”) representing the relationship between the residual insulin amount and the elapsed time from the previous bolus. In order to simplify the explanation, it is assumed that insulin administered into the living body decreases at a constant rate as time passes, as shown in FIG. For this reason, the residual insulin relational expression is a linear function.
 上記の「残存インスリン量」および式1中における「送液予定量」の計算は、コントローラ200が備える第1制御部260、送液部100が備える第2制御部50、およびインスリンペン400が備える第3制御部460により実行される。各制御部の機能について、図6に示す薬液投与セット500のブロック図を参照しながら説明する。 The calculation of the “residual insulin amount” and the “scheduled liquid supply amount” in Equation 1 is provided in the first control unit 260 provided in the controller 200, the second control unit 50 provided in the liquid supply unit 100, and the insulin pen 400. This is executed by the third control unit 460. The function of each control unit will be described with reference to the block diagram of the drug solution administration set 500 shown in FIG.
 まず、インスリンペン400が備える第3制御部460の機能について説明する。 First, the function of the third control unit 460 provided in the insulin pen 400 will be described.
 インスリンペン400が備える第3制御部460は、第3通信部450、注入ボタン440および電池470に接続されており、これらの動作を統括して制御する。具体的には第3制御部460は、注入ボタン440が押された場合、送液が行われたことを検知し、第3通信部450からインスリン投与装置300の送液部100へ第2データを送信する。 The third control unit 460 provided in the insulin pen 400 is connected to the third communication unit 450, the injection button 440, and the battery 470, and controls these operations in an integrated manner. Specifically, when the injection button 440 is pressed, the third control unit 460 detects that liquid feeding has been performed, and the second data is sent from the third communication unit 450 to the liquid feeding unit 100 of the insulin administration device 300. Send.
 なお、本実施形態における「第2データ」には、インスリン投与装置300の送液部100による送液動作が停止している最中に、インスリンペン400によって生体内に送液したインスリンの送液量およびインスリンペン400がインスリンの送液を終了した際の送液終了時刻が含まれる。 In the “second data” in the present embodiment, the feeding of insulin delivered into the living body by the insulin pen 400 while the feeding operation by the feeding unit 100 of the insulin administration device 300 is stopped. The amount and the delivery end time when the insulin pen 400 finishes delivering the insulin are included.
 次に、送液部100が備える第2制御部50の機能について説明する。 Next, the function of the second control unit 50 provided in the liquid feeding unit 100 will be described.
 送液部100が備える第2制御部50は、第2通信部40、モータ32および電池27に接続され、第1制御部260の指示を受けてこれらの動作を制御する。また、第2制御部50は、送液部100が生体内へ送液したインスリンの送液量に関する第1データ、およびインスリンペン400が生体内へ送液したインスリンの送液量に関する第2データを管理するデータ管理部51としての機能を備える。 The 2nd control part 50 with which the liquid feeding part 100 is provided is connected to the 2nd communication part 40, the motor 32, and the battery 27, receives these instructions of the 1st control part 260, and controls these operations. The second control unit 50 also includes first data relating to the amount of insulin delivered by the fluid delivery unit 100 to the living body, and second data relating to the amount of insulin delivered by the insulin pen 400 to the living body. A function as a data management unit 51 for managing
 なお、本実施形態における「第1データ」には、前回のボーラスモード時に送液部100が生体内へ送液したインスリンの送液量および送液部100がインスリンの送液を終了した際の送液終了時刻が含まれる。 The “first data” in the present embodiment includes the amount of insulin delivered by the fluid delivery unit 100 into the living body and the time when the fluid delivery unit 100 finished delivering the insulin in the previous bolus mode. The liquid delivery end time is included.
 第2制御部50は、第1データを送液部100のモータ32の駆動信号からを取得し、前述したように、インスリンペン400から送信される第2データを第2通信部40において取得する。 The second control unit 50 acquires the first data from the drive signal of the motor 32 of the liquid feeding unit 100, and acquires the second data transmitted from the insulin pen 400 in the second communication unit 40 as described above. .
 なお、コントローラ200が備える受付部230は、使用者からの第2データの入力を受け付けるデータ入力受付部に相当する機能も有している。そのため、例えば、インスリンペン400の無線通信機能が故障等して機能が停止している場合、使用者は、受付部230に第2データを直接入力することができる。 The receiving unit 230 provided in the controller 200 also has a function corresponding to a data input receiving unit that receives second data input from the user. Therefore, for example, when the wireless communication function of the insulin pen 400 is stopped due to a failure or the like, the user can directly input the second data to the reception unit 230.
 データ管理部51は、前回ボーラス時の送液量および送液終了時刻(以下、「前回ボーラスデータ」と称する)を記憶している。データ管理部51は、第1データおよび第2データが取得された場合は、前回ボーラスデータを更新する。例えば、送液部100によってボーラスモードにおける送液が行われ、第2制御部50が第1データを取得した場合は、当該第1データを前回ボーラスデータとして記憶する。その後、第2通信部40が第2データを取得した場合は、当該第2データを前回ボーラスデータとして更新する。 The data management unit 51 stores a liquid supply amount and a liquid supply end time (hereinafter referred to as “previous bolus data”) at the previous bolus. When the first data and the second data are acquired, the data management unit 51 updates the previous bolus data. For example, when the liquid supply unit 100 performs liquid supply in the bolus mode and the second control unit 50 acquires the first data, the first data is stored as the previous bolus data. Thereafter, when the second communication unit 40 acquires the second data, the second data is updated as the previous bolus data.
 次に、第1制御部260の機能について説明する。 Next, the function of the first control unit 260 will be described.
 コントローラ200の備える第1制御部260は、第1通信部250、表示部220、受付部230および電源部240に接続されており、これらの動作を統括的に制御する。 The first control unit 260 included in the controller 200 is connected to the first communication unit 250, the display unit 220, the reception unit 230, and the power supply unit 240, and comprehensively controls these operations.
 また、第1制御部260は、第1データまたは第2データに基づいて生体内における残存インスリン量の計算および当該残存インスリン量に基づいたインスリンの送液予定量の計算を実行する演算部261と、演算部261の計算に必要な各種のデータ等を記憶する記憶部262としての機能を備えている。 In addition, the first control unit 260 calculates a residual insulin amount in the living body based on the first data or the second data, and calculates a liquid delivery scheduled amount based on the residual insulin amount. , A function as a storage unit 262 for storing various data necessary for calculation of the calculation unit 261 is provided.
 記憶部262は、演算部261の計算に必要なデータとして、インスリン炭水化物比、目標血糖値、インスリン効果値、および残存インスリン関係式の各パラメータを記憶する。これらのパラメータは、使用者が受付部230を介して予め入力し、使用に先立って設定しておくことが可能である。 The storage unit 262 stores each parameter of the insulin carbohydrate ratio, the target blood glucose level, the insulin effect value, and the residual insulin relational expression as data necessary for the calculation of the calculation unit 261. These parameters can be input in advance by the user via the receiving unit 230 and set prior to use.
 次に、図7および図8を参照して、インスリン投与装置300の動作処理を説明する。 Next, the operation process of the insulin administration device 300 will be described with reference to FIGS.
 まず、コントローラ200の動作処理について説明する。 First, the operation process of the controller 200 will be described.
 図7に示すように、コントローラ200の備える第1制御部260は、受付部230を介して使用者からのボーラスモードにおける送液指示を受け付けると、表示部220を介して使用者に炭水化物量の入力を指示する(S11)。指示を受けた使用者は、直前に摂取した食事内容から求まる炭水化物量を受付部230の備える入力ボタンを介して入力する。 As illustrated in FIG. 7, when the first control unit 260 included in the controller 200 receives a liquid feeding instruction in the bolus mode from the user via the reception unit 230, the first control unit 260 provides the user with the carbohydrate amount via the display unit 220. Input is instructed (S11). The user who receives the instruction inputs the amount of carbohydrate obtained from the content of the meal taken immediately before, via the input button provided in the reception unit 230.
 次に、第1制御部260は、表示部220を介して使用者に血糖値の入力を指示する(S12)。指示を受けた使用者は、公知の血糖値測定装置などを用いて測定した食事前の血糖値を受付部230の備える入力ボタンを介して入力する。 Next, the first control unit 260 instructs the user to input a blood glucose level via the display unit 220 (S12). The user who receives the instruction inputs the blood glucose level before meal measured using a known blood glucose level measuring device or the like via an input button provided in the reception unit 230.
 次に、第1制御部260は、第1通信部250の無線通信機能を用いて第2制御部50のデータ管理部51へ前回ボーラスデータを要求する(S13)。 Next, the first control unit 260 requests the previous bolus data from the data management unit 51 of the second control unit 50 using the wireless communication function of the first communication unit 250 (S13).
 次に、第1制御部260は、ステップ(S13)の要求に応じて、データ管理部51が第2通信部40を介して送信した前回ボーラスデータを、第1通信部250を介して受信する(S14)。 Next, the 1st control part 260 receives the last bolus data which the data management part 51 transmitted via the 2nd communication part 40 via the 1st communication part 250 according to the request | requirement of step (S13). (S14).
 第1制御部260の演算部261は、ステップ(S14)において受信した前回ボーラスデータに基づいて残存インスリン量を計算する(S15)。具体的には、演算部261は、残存インスリン量を計算するに際し、まず、前回ボーラス時の送液終了時刻に基づいて、送液部100による送液を開始する送液開始時刻までの経過時間を計算する。そして、演算部261は、前回ボーラス時の送液量および計算した経過時間を記憶部262に記憶されている残存インスリン関係式に当てはめることによって、残存インスリン量を計算する。 The calculation unit 261 of the first control unit 260 calculates the remaining insulin amount based on the previous bolus data received in step (S14) (S15). Specifically, when calculating the residual insulin amount, the calculation unit 261 firstly passes an elapsed time from the liquid feeding end time at the previous bolus to the liquid feeding start time at which liquid feeding by the liquid feeding unit 100 is started. Calculate Then, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the calculated elapsed time to the residual insulin relational expression stored in the storage unit 262.
 ステップ(S15)の後、演算部261は、記憶部262からインスリン炭水化物比、インスリン効果値および目標血糖値を取得する(S16)。 After step (S15), the calculation unit 261 acquires the insulin carbohydrate ratio, the insulin effect value, and the target blood glucose level from the storage unit 262 (S16).
 次に、演算部261は、ステップ(S11)およびステップ(S12)において受付部230から取得した炭水化物量および測定血糖値と、ステップ(S15)において計算した残存インスリン量と、ステップ(S16)において記憶部262から取得したインスリン炭水化物比、インスリン効果値および目標血糖値と、を前述した式1に当てはめて、送液予定量を計算する(S17)。 Next, the calculation unit 261 stores the carbohydrate amount and the measured blood glucose level acquired from the receiving unit 230 in step (S11) and step (S12), the residual insulin amount calculated in step (S15), and the memory in step (S16). The insulin / carbohydrate ratio, the insulin effect value, and the target blood glucose level acquired from the unit 262 are applied to the above-described equation 1 to calculate the liquid feeding scheduled amount (S17).
 次に、第1制御部260は、第1通信部250の無線通信機能を用いて、ボーラスモードにおいて送液予定量のインスリンを送液すべき旨の送液指示を送液部100へ送信する(S18)。ステップ(S18)の動作処理が完了した後、第1制御部260は、使用者からの指示を再び受け付けるまで待機する。 Next, the first control unit 260 uses the wireless communication function of the first communication unit 250 to transmit to the liquid feeding unit 100 a liquid feeding instruction indicating that a predetermined amount of insulin to be delivered in the bolus mode. (S18). After the operation process of step (S18) is completed, the first control unit 260 waits until it receives an instruction from the user again.
 以上が、コントローラ200が使用者からボーラスモードにおける送液指示を受けた場合の動作処理である。 The above is the operation process when the controller 200 receives a liquid feeding instruction in the bolus mode from the user.
 次に、送液部100が備える第2制御部50の動作処理について説明する。 Next, an operation process of the second control unit 50 provided in the liquid feeding unit 100 will be described.
 図8に示すように第2制御部50は、第2通信部40が動作処理に関する信号を受信した場合、その信号がインスリンペン400から送信された信号か否かを判定する(S21)。 As shown in FIG. 8, when the second communication unit 40 receives a signal related to the operation process, the second control unit 50 determines whether or not the signal is a signal transmitted from the insulin pen 400 (S21).
 ステップ(S21)において、受信した信号がインスリンペン400から送信されたものであると判定された場合(S21;Yes)、データ管理部51は、インスリンペン400から取得した第2データを前回ボーラスデータとして更新する(S22)。 If it is determined in step (S21) that the received signal is transmitted from the insulin pen 400 (S21; Yes), the data management unit 51 uses the second data acquired from the insulin pen 400 as the previous bolus data. (S22).
 次に、第2制御部50は、コントローラ200から送信された信号を受信しているか否かを判定する(S23)。 Next, the second control unit 50 determines whether or not a signal transmitted from the controller 200 is received (S23).
 ステップ(S23)において、コントローラ200から送信された信号を受信していいと判定された場合(S23;No)、第2制御部50は、第2通信部40が信号を再度受信するまで待機する。 In Step (S23), when it is determined that the signal transmitted from the controller 200 can be received (S23; No), the second control unit 50 waits until the second communication unit 40 receives the signal again.
 ステップ(S23)において、コントローラ200から送信された信号を受信していると判定された場合(S23;Yes)、第2制御部50は、その信号が前回ボーラスデータを要求するものであるか否かを判定する(S25)。 When it is determined in step (S23) that the signal transmitted from the controller 200 is received (S23; Yes), the second control unit 50 determines whether or not the signal requests previous bolus data. Is determined (S25).
 また、ステップ(S21)において、受信した信号がインスリンペン400から送信されたものではないと判定された場合(S21;No)、第2制御部50は、その信号がコントローラ200から送信されたものであるか否かを判定する(S24)。 When it is determined in step (S21) that the received signal is not transmitted from the insulin pen 400 (S21; No), the second control unit 50 transmits the signal from the controller 200. It is determined whether or not (S24).
 ステップ(S24)において、受信した信号がコントローラ200から送信されたものではないと判定された場合(S24;No)、第2制御部50は、信号の受信が行われなかった旨のエラー表示を表示部220に表示するように、第1制御部260へ指示信号を送信する。その後、第2制御部50は信号を再び受信するまで待機する。 When it is determined in step (S24) that the received signal is not transmitted from the controller 200 (S24; No), the second control unit 50 displays an error display indicating that the signal has not been received. An instruction signal is transmitted to the first control unit 260 so as to be displayed on the display unit 220. Thereafter, the second control unit 50 stands by until the signal is received again.
 ステップ(S24)において、受信した信号がコントローラ200から送信されたものであると判定された場合(S24;Yes)、第2制御部50は、その信号が前回ボーラスデータを要求するものであるかどうかを判定する(S25)。 When it is determined in step (S24) that the received signal is transmitted from the controller 200 (S24; Yes), the second control unit 50 requests the previous bolus data. It is determined whether or not (S25).
 ステップ(S25)において、受信した信号が前回ボーラスデータを要求するものであると判定された場合(S25;Yes)、第2制御部50は、データ管理部51に記憶されている前回ボーラスデータを第2通信部40の無線通信機能を用いてコントローラ200の第1制御部260へ送信する(S26)。 If it is determined in step (S25) that the received signal is a request for previous bolus data (S25; Yes), the second control unit 50 stores the previous bolus data stored in the data management unit 51. It transmits to the 1st control part 260 of the controller 200 using the radio | wireless communication function of the 2nd communication part 40 (S26).
 ステップ(S26)の動作処理が完了した後、第2制御部50は、信号の受信があるまで再び待機する。 After the operation process of step (S26) is completed, the second control unit 50 waits again until a signal is received.
 ステップ(S25)において、受信した信号が前回ボーラスデータを要求するものではないと判定された場合(S25;No)、第2制御部50は、その信号がボーラスモードでの送液を実施すべき旨の指示信号であるか否かを判定する(S31)。 In step (S25), when it is determined that the received signal does not require the previous bolus data (S25; No), the second control unit 50 should carry out liquid feeding in the bolus mode. It is determined whether or not it is an instruction signal to that effect (S31).
 ステップ(S31)において、受信した信号がボーラスモードでの送液を実施すべき旨の指示信号であると判定された場合(S31;Yes)、第2制御部50は、送液予定量のインスリンが送液されるようにモータ32を電気的に制御して、ボーラスモードでの送液を行う(S32)。このとき、第2制御部50は、送液部100が送液した送液量および送液終了時刻を含む第1データを送液部100のモータ32の駆動信号から取得する。 In step (S31), when it is determined that the received signal is an instruction signal indicating that the liquid delivery in the bolus mode should be performed (S31; Yes), the second control unit 50 determines the amount of insulin to be delivered. Then, the motor 32 is electrically controlled so that the liquid is fed in the bolus mode (S32). At this time, the 2nd control part 50 acquires the 1st data containing the amount of liquid feeding which liquid feeding part 100 sent, and liquid feeding end time from the drive signal of motor 32 of liquid feeding part 100.
 次に、データ管理部51は、ステップ(S32)において取得した第1データを前回ボーラスデータとして更新する(S33)。その後、第2制御部50は、信号の受信があるまで再び待機する。 Next, the data management unit 51 updates the first data acquired in step (S32) as the previous bolus data (S33). Thereafter, the second control unit 50 waits again until a signal is received.
 また、ステップ(S31)において、受信した信号がボーラスモードでの送液を実施すべき旨の指示信号ではないと判定された場合(S31;No)、第2制御部50はその信号がベーサルモードでの送液を実施すべき旨の指示信号であるか否かを判定する(S41)。 In Step (S31), when it is determined that the received signal is not an instruction signal indicating that the liquid delivery in the bolus mode should be performed (S31; No), the second control unit 50 indicates that the signal is in the basal mode. In step S41, it is determined whether or not the instruction signal indicates that liquid feeding is to be performed.
 ステップ(S41)において、受信した信号がベーサルモードでの送液を実施すべき旨の指示信号であると判定された場合(S41;Yes)、第2制御部50は、所定量のインスリンが経時的に送液されるようにモータ32の動作を制御し、ベーサルモードでの送液を実施させる(S42)。 In step (S41), when it is determined that the received signal is an instruction signal indicating that the liquid feeding in the basal mode should be performed (S41; Yes), the second control unit 50 determines that a predetermined amount of insulin has elapsed over time. Then, the operation of the motor 32 is controlled so that the liquid is fed, and the liquid is fed in the basal mode (S42).
 ステップ(S41)において、受信した信号がベーサルモードでの送液を実施すべき旨の指示信号ではないと判定された場合(S41;No)、第2制御部50は、コントローラ200の第1制御部260へ受信した信号の指示内容を確認する(S43)。 When it is determined in step (S41) that the received signal is not an instruction signal indicating that the liquid supply in the basal mode should be performed (S41; No), the second control unit 50 performs the first control of the controller 200. The instruction content of the signal received to the unit 260 is confirmed (S43).
 ステップ(S42)またはステップ(S43)の動作処理が完了した後、第2制御部50は、信号を再度受信するまで待機する。 After the operation process of step (S42) or step (S43) is completed, the second control unit 50 waits until a signal is received again.
 次に、図9を参照して、残存インスリン量および送液予定量の計算例を説明する。 Next, with reference to FIG. 9, a calculation example of the residual insulin amount and the scheduled liquid delivery amount will be described.
 図9(A)は、送液部100がボーラスモードで送液量Vのインスリンを送液し、送液動作を送液終了時刻t0fで終了した場合の送液例を示す図である。 FIG. 9A is a diagram showing an example of liquid feeding when the liquid feeding unit 100 delivers insulin of the liquid feeding amount V 0 in the bolus mode, and the liquid feeding operation is finished at the liquid feeding end time t 0f . .
 この送液例では、送液量Vおよび送液終了時刻t0fを含む第1データが、前回ボーラスデータとしてデータ管理部51に記憶される。送液量Vの送液が行われた後に使用者からボーラスモードでの送液を行う旨の指示があった場合、演算部261は、送液終了時刻t0fに基づいて、送液部100によって送液を行う送液開始時刻tまでの経過時間Δtを計算する。続いて演算部261は、前回ボーラス時の送液量および上記の経過時間Δtを残存インスリン関係式に当てはめて、残存インスリン量の計算を行う。この場合、投与量がV、経過時間がΔtであるため、図5(B)に示すように残存インスリン量はVとなる。 In this liquid feeding example, the first data including the liquid feeding amount V 0 and the liquid feeding end time t 0f is stored in the data management unit 51 as previous bolus data. When the user gives an instruction to perform liquid feeding in the bolus mode after the liquid feeding amount V 0 has been delivered, the calculation unit 261 uses the liquid feeding unit based on the liquid feeding end time t 0f. The elapsed time Δt until the liquid feeding start time t n at which liquid feeding is performed by 100 is calculated. Subsequently, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the above-described elapsed time Δt to the residual insulin relational expression. In this case, since the dose is V 0 and the elapsed time is Δt, the residual insulin amount is V t as shown in FIG.
 演算部261は、残存インスリン量Vなどを前述の式1に当てはめて、送液予定量Vを計算する。そして、第2制御部50は、計算された送液予定量Vのインスリンが送液されるように、送液部100が備えるモータ32の回転量を調整し、ボーラスモードでの送液を実施する。第2制御部50は、このとき送液される送液量Vおよび送液終了時刻tnfを含む第1データを、送液部100が備えるモータ32の駆動信号から取得する。データ管理部51は、第2制御部50が取得した第1データを前回ボーラスデータとして更新する。 The calculation unit 261 calculates the liquid feeding scheduled amount V n by applying the residual insulin amount V t and the like to the above-described equation 1. The second control unit 50, like insulin calculated feeding predetermined quantity V n is fed, by adjusting the amount of rotation of the motor 32 feeding section 100 is provided, the liquid delivery bolus mode carry out. The second control unit 50, the first data including a liquid supply rate V n and feeding end time t nf which is fed this time is acquired from the drive signal of the motor 32 to the liquid feed portion 100. The data management unit 51 updates the first data acquired by the second control unit 50 as the previous bolus data.
 図9(B)は、送液部100による送液動作が停止している最中に、インスリンペン400を使用して送液量Vのインスリンを送液し、送液動作を送液終了時刻t0fで終了した場合の送液例を示す図である。 In FIG. 9B, while the liquid feeding operation by the liquid feeding unit 100 is stopped, the insulin pen 400 is used to feed the insulin of the liquid feeding amount V 0 and the liquid feeding operation is finished. It is a figure which shows the liquid feeding example at the time of complete | finishing at time t0f .
 この送液例では、インスリンペン400から送信される送液量Vおよび送液終了時刻t0fを含む第2データが前回ボーラスデータとしてデータ管理部51に記憶される。インスリンペン400による送液を終えた後、送液部100によってボーラスモードでの送液を行う場合、演算部261は、送液終了時刻t0fに基づいて、送液部100によって送液を行う送液開始時刻tまでの経過時間Δtを計算する。続いて演算部261は、前回ボーラス時の送液量および上記の経過時間Δtを残存インスリン関係式に当てはめて、残存インスリン量の計算を行う。この場合、投与量がV、経過時間がΔtであるため、図5(B)に示すように残存インスリン量はVとなる。 In this liquid feeding example, the second data including the liquid feeding amount V 0 and the liquid feeding end time t 0f transmitted from the insulin pen 400 is stored in the data management unit 51 as previous bolus data. When liquid feeding in the bolus mode is performed by the liquid feeding unit 100 after the liquid feeding by the insulin pen 400 is finished, the calculation unit 261 performs liquid feeding by the liquid feeding unit 100 based on the liquid feeding end time t0f. to calculate the elapsed time Δt until the liquid feeding start time t n. Subsequently, the calculation unit 261 calculates the residual insulin amount by applying the liquid feeding amount at the previous bolus and the above-described elapsed time Δt to the residual insulin relational expression. In this case, since the dose is V 0 and the elapsed time is Δt, the residual insulin amount is V t as shown in FIG.
 演算部261は、残存インスリン量Vなどを前述の式1に当てはめて、送液予定量Vを計算する。そして、第2制御部50は、計算された送液予定量Vのインスリンが送液されるように、送液部100が備えるモータ32の回転量を調整し、ボーラスモードでの送液を実施する。第2制御部50は、このとき送液される送液量Vおよび送液終了時刻tnfを含む第1データを、送液部100が備えるモータ32の駆動信号から取得する。データ管理部51は、第2制御部50が取得した第1データを前回ボーラスデータとして更新する。 The calculation unit 261 calculates the liquid feeding scheduled amount V n by applying the residual insulin amount V t and the like to the above-described equation 1. The second control unit 50, like insulin calculated feeding predetermined quantity V n is fed, by adjusting the amount of rotation of the motor 32 feeding section 100 is provided, the liquid delivery bolus mode carry out. The second control unit 50, the first data including a liquid supply rate V n and feeding end time t nf which is fed this time is acquired from the drive signal of the motor 32 to the liquid feed portion 100. The data management unit 51 updates the first data acquired by the second control unit 50 as the previous bolus data.
 以上説明したように、本実施形態に係るインスリン投与装置300は、インスリンペン400などの他の送液器具によって生体内にインスリンが投与された場合、その投与されたインスリンの生体内における残存量を考慮して、インスリンの送液予定量を適切な量に定めることができる。 As described above, the insulin administration device 300 according to the present embodiment, when insulin is administered into the living body by another liquid delivery device such as the insulin pen 400, indicates the remaining amount of the administered insulin in the living body. Considering this, it is possible to determine the amount of insulin to be delivered to an appropriate amount.
 本実施形態に係るインスリン投与装置300によれば、当該インスリン投与装置300以外の他の送液器具であるインスリンペン400等によってインスリンが送液(投与)された場合、その送液量に関する第2データを取得し、必要に応じて第2データに基づいて生体内におけるインスリンの残存量を計算し、さらにインスリンの残存量に基づいた適正な送液予定量を計算する。そして、各制御部50、260により、送液予定量の薬液が送液されるように送液部100の動作が制御されるため、インスリンペン400等によってインスリンの投与が行われたような場合においても、生体内におけるインスリンの残存量を考慮した適切な送液量でインスリンを投与することが可能になる。 According to the insulin administration device 300 according to the present embodiment, when insulin is delivered (administered) by the insulin pen 400 or the like, which is another fluid delivery device other than the insulin administration device 300, the second related to the amount of fluid delivered. Data is acquired, and if necessary, the remaining amount of insulin in the living body is calculated based on the second data, and an appropriate scheduled liquid delivery amount is calculated based on the remaining amount of insulin. The operation of the liquid feeding unit 100 is controlled by each control unit 50 and 260 so that a predetermined amount of liquid medicine is fed, and thus insulin is administered by the insulin pen 400 or the like. In this case, it is possible to administer insulin with an appropriate liquid feeding amount in consideration of the remaining amount of insulin in the living body.
 また、インスリン投与装置300によれば、第2通信部40が、インスリンペン400から無線通信により送信される第2データを取得可能に構成されているため、使用者の手入力の手間を省くことができ、また、入力漏れ等が発生するのを未然に防ぐことが可能になる。 Further, according to the insulin administration device 300, the second communication unit 40 is configured to be able to acquire the second data transmitted from the insulin pen 400 by wireless communication, so that the user's manual input is saved. In addition, it is possible to prevent input leakage and the like from occurring.
 また、インスリン投与装置300によれば、受付部230が第2データの入力を外部から受け付けるデータ入力受付部に相当する機能を有する。このため、無線通信機能を備えない他の送液器具等を使用して送液が行われたような場合においても、インスリン投与装置300は第2データを取得することが可能になるため、インスリンの残存量に基づいた適切な送液量での送液を実施することが可能になる。 In addition, according to the insulin administration device 300, the reception unit 230 has a function corresponding to a data input reception unit that receives the input of the second data from the outside. For this reason, since the insulin administration device 300 can acquire the second data even when liquid feeding is performed using another liquid feeding device or the like that does not have a wireless communication function, the insulin administration device 300 can acquire the second data. It is possible to carry out liquid feeding with an appropriate liquid feeding amount based on the remaining amount of the liquid.
 また、インスリン投与装置300によれば、第1データが、送液部100がインスリンの送液を終了した際の送液終了時刻を含み、第2データが、インスリンペン400による送液を終了した際の送液終了時刻を含むため、インスリンの投与を再開する直前に実施された時間経過に基づいてより適切な生体内の薬液の残存量を計算することができる。 Further, according to the insulin administration device 300, the first data includes the liquid delivery end time when the liquid delivery unit 100 finishes delivering the insulin, and the second data finishes the liquid delivery by the insulin pen 400. Therefore, it is possible to calculate a more appropriate remaining amount of the medical solution in the living body based on the passage of time performed immediately before resuming the administration of insulin.
 また、インスリン投与装置300によれば、送液部100は、薬液としてインスリンを送液可能に構成されており、さらに、一定量のインスリンを継続的に送液するベーサルモードに対して単位時間当たりのインスリンの送液量を一時的に増加して送液するボーラスモードでの送液動作を実施可能に構成されている。そして、第1データは、送液部100が前記ボーラスモードで動作した際に送液したインスリンの送液量に関するデータを含み、第2データは、送液部100による送液動作が停止している最中に、インスリンペン400が送液したインスリンの送液量に関するデータを含む。このため、ボーラスモードの送液を実施している最中に送液部100の送液動作が停止し、代替的にインスリンペン400などを使用してインスリンを投与した後に、インスリン投与装置300を使用してインスリンの投与を再開する場合においても、インスリンペン400によって送液したインスリンの生体内における残存量を考慮した適切な量のインスリンを投与することが可能になる。 Further, according to the insulin administration device 300, the liquid feeding unit 100 is configured to be able to deliver insulin as a chemical solution, and further, per unit time with respect to the basal mode in which a constant amount of insulin is continuously fed. It is configured to be able to perform a liquid feeding operation in a bolus mode in which the amount of insulin delivered is temporarily increased. The first data includes data related to the amount of insulin delivered when the liquid delivery unit 100 operates in the bolus mode, and the second data includes the liquid delivery operation by the liquid delivery unit 100 being stopped. In the meantime, data on the amount of insulin delivered by the insulin pen 400 is included. For this reason, the liquid feeding operation of the liquid feeding unit 100 is stopped while the liquid feeding in the bolus mode is being performed, and after the insulin is administered using the insulin pen 400 or the like, the insulin administration device 300 is Even when the administration of insulin is resumed by using the insulin pen, it is possible to administer an appropriate amount of insulin in consideration of the residual amount of the insulin delivered by the insulin pen 400 in the living body.
 <変形例>
 次に実施形態の変形例について説明する。実施形態に係るインスリン投与装置300は、第1データまたは第2データが取得される度に、データ管理部51は前回ボーラスデータを更新する構成である。このため、残存インスリン量は第1データまたは第2データのいずれかに基づいて計算される。これに対して実施形態の変形例では、データ管理部51は、取得した第1データおよび第2データを、各データの送液終了時刻から所定時間が経過するまで記憶するように構成される。
<Modification>
Next, a modification of the embodiment will be described. The insulin administration device 300 according to the embodiment has a configuration in which the data management unit 51 updates the previous bolus data every time the first data or the second data is acquired. Therefore, the remaining insulin amount is calculated based on either the first data or the second data. On the other hand, in the modification of the embodiment, the data management unit 51 is configured to store the acquired first data and second data until a predetermined time elapses from the liquid feeding end time of each data.
 ここで、実施形態の変形例に係るインスリン投与装置300の残存インスリン量および送液予定量の計算方法について説明する。 Here, a method of calculating the remaining insulin amount and the planned liquid delivery amount of the insulin administration device 300 according to the modification of the embodiment will be described.
 図10は、実施形態の変形例に係るインスリン投与装置300の送液部100による送液が故障等によって中断され、その直後に送液部100によって送液しきれなかった不足分をインスリンペン400による送液で補った場合を示す。この場合、データ管理部51は、送液部100の送液した送液量Vおよび送液終了時刻t0fを含む第1データを送液終了時刻t0fから所定時間T経過するまで記憶し、インスリンペン400の送液した送液量Vおよび送液終了時刻t1fを含む第2データを送液終了時刻t1fから所定時間T経過するまで記憶する。 FIG. 10 shows an insulin pen 400 in which the liquid feeding by the liquid feeding unit 100 of the insulin administration device 300 according to the modified example of the embodiment is interrupted due to a failure or the like, and immediately after that, the shortage that the liquid feeding unit 100 could not feed completely. The case where it is supplemented with liquid feeding by is shown. In this case, the data management unit 51 stores the first data including the liquid supply amount V 0 and the liquid supply end time t 0f supplied by the liquid supply unit 100 until a predetermined time T elapses from the liquid supply end time t 0f. The second data including the liquid feeding amount V 1 and the liquid feeding end time t 1f sent by the insulin pen 400 is stored until a predetermined time T elapses from the liquid feeding end time t 1f .
 続いて時刻tにおいて次の送液を開始しようとする場合、演算部261は、データ管理部51に記憶されている第1データおよび第2データそれぞれに基づく残存インスリン量を計算する。なお、各データに基づく残存インスリン量の計算方法は、実施形態に示した方法と同様の方法で行う。続いて、演算部261は、各残存インスリン量を足し合わせ、足し合わせた残存インスリン量に基づいて送液予定量Vを計算する。このとき第2制御部50は、このとき送液される送液量Vおよび送液終了時刻tnfを含む第1データを、送液部100が備えるモータ32の駆動信号から取得する。そして、データ管理部51は、第2制御部50が取得した第1データを送液終了時刻tnfから所定時間T経過するまで記憶する。ここで所定時間Tには、ボーラスモードで想定される最大送液量で送液された場合に残存インスリン量が0になるまでの経過時間が選択される。 Subsequently, when the next liquid delivery is to be started at time t n , the calculation unit 261 calculates a residual insulin amount based on the first data and the second data stored in the data management unit 51. In addition, the calculation method of the residual insulin amount based on each data is performed by the method similar to the method shown in the embodiment. Subsequently, the calculation unit 261 adds the remaining insulin amounts, and calculates a liquid feeding scheduled amount V n based on the added remaining insulin amounts. At this time, the second control unit 50 obtains first data including the liquid supply amount V n and the liquid supply end time t nf to be supplied from the drive signal of the motor 32 included in the liquid supply unit 100. And the data management part 51 memorize | stores the 1st data which the 2nd control part 50 acquired until predetermined time T passes from liquid feeding end time tnf . Here, as the predetermined time T, an elapsed time until the residual insulin amount becomes 0 when the fluid is delivered at the maximum fluid delivery amount assumed in the bolus mode is selected.
 以上説明したように、本実施形態の変形例に係るインスリン投与装置は、第1および第2データに基づいて残存インスリン量を計算する。 As described above, the insulin administration device according to the modification of the present embodiment calculates the residual insulin amount based on the first and second data.
 以上のように複数の実施形態を通じて本発明に係る薬液投与装置300を説明したが、本発明に係る薬液投与装置300は実施形態において説明した構成のみに限定されるものではなく、特許請求の範囲の記載に基づいて種々改変することが可能である。 As described above, the drug solution administration device 300 according to the present invention has been described through a plurality of embodiments. However, the drug solution administration device 300 according to the present invention is not limited to the configuration described in the embodiment, and Various modifications can be made based on the description.
 例えば、実施形態に係る薬液投与装置300では、送液する薬液としてインスリンを用いたがこれに限定されない。例えば、制限されず、インスリン、抗生物質、栄養剤、鎮痛剤、ホルモン剤などの薬液の投与に用いることも可能である。薬液の種類および投与方法に合わせて、生体内に残存する薬液の量および送液予定量の計算方法を適宜変更することが可能である。 For example, in the drug solution administration device 300 according to the embodiment, insulin is used as the drug solution to be fed, but is not limited thereto. For example, without limitation, it can also be used for administration of drug solutions such as insulin, antibiotics, nutrients, analgesics, hormones and the like. The calculation method of the amount of the chemical solution remaining in the living body and the planned liquid delivery amount can be appropriately changed according to the type and administration method of the chemical solution.
 また、例えば、実施形態に係る薬液投与装置300では、送液部100と、送液部100とは別体のコントローラ200と、を有する構成としたがこれに限定されない。例えば、コントローラ200の備える機能を送液部100に統合し、薬液投与装置300を一体の構成とすることも可能である。 In addition, for example, in the liquid medicine administration device 300 according to the embodiment, the liquid feeding unit 100 and the controller 200 separate from the liquid feeding unit 100 are configured, but the configuration is not limited thereto. For example, it is possible to integrate the functions of the controller 200 into the liquid delivery unit 100 and to make the drug solution administration device 300 an integral configuration.
 また、例えば、本実施形態に係る薬液投与装置300では、送液部100を注入部10、送液ディスポ部20および送液リユース部30を組合せる構成としたが、これに限定されない。例えば、注入部10、送液ディスポ部20および送液リユース部30を一体の構成とすることも可能である。 Further, for example, in the liquid medicine administration device 300 according to the present embodiment, the liquid feeding unit 100 is configured to combine the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30, but the present invention is not limited thereto. For example, the injection unit 10, the liquid feeding disposable unit 20, and the liquid feeding reuse unit 30 can be integrated.
 また、例えば、実施形態に係る薬液投与装置300では、第1制御部260と第2制御部50とを有する構成としたが、これに限定されない。例えば、薬液投与装置300がコントローラを備えない構成であるときは、制御部を1つにすることも可能である。 Further, for example, the chemical liquid administration device 300 according to the embodiment has the first control unit 260 and the second control unit 50, but is not limited thereto. For example, when the medicinal solution administration device 300 is configured not to include a controller, it is possible to have one control unit.
 また、例えば、実施形態に係る薬液投与装置300では、生体内に投与された薬液(インスリン)は経過時間に対して一定の割合で減少するものとした。しかし、例えば、薬液の減少割合が経時的に変化するものとして、薬液の残存量を計算することも可能である。 Also, for example, in the drug solution administration device 300 according to the embodiment, the drug solution (insulin) administered into the living body decreases at a constant rate with respect to the elapsed time. However, for example, the remaining amount of the chemical solution can be calculated on the assumption that the decreasing rate of the chemical solution changes with time.
 また、例えば、実施形態に係る薬液投与装置300では、送液部100の第2通信部40が他の送液器具と無線通信可能な機能を備える構成としたが、これに限定されない。例えば、コントローラ200の備える第1通信部250が他の送液器具と無線通信可能な機能を備える構成とすることも可能である。また、例えば、データ入力受付部(受付部230)へのみによって第2データを取得する構成とすることも可能である。 Further, for example, in the drug solution administration device 300 according to the embodiment, the second communication unit 40 of the liquid feeding unit 100 has a function capable of wirelessly communicating with other liquid feeding devices, but is not limited thereto. For example, the first communication unit 250 included in the controller 200 may be configured to have a function capable of wirelessly communicating with other liquid delivery devices. Further, for example, the second data can be acquired only by the data input receiving unit (receiving unit 230).
 また、例えば、実施形態に係る薬液投与装置300では、データ入力受付部(受付部230)はボタン入力によって外部からの第2データの入力を受付ける構成としたが、これに限定されない。例えば、データ入力受付部をタッチパネルまたは音声によって受付可能な構成にすることも可能である。 Further, for example, in the drug solution administration device 300 according to the embodiment, the data input reception unit (reception unit 230) is configured to receive the input of the second data from the outside by button input, but is not limited thereto. For example, the data input receiving unit can be configured to be able to receive by touch panel or voice.
 また、例えば、実施形態に係る薬液投与装置300では、第1データおよび第2データは送液時の送液量および送液終了時刻を含む構成としたがこれに限定されない。例えば、送液動作が定期的に行われるような場合は、第1および第2データは送液量のみからなるとすることも可能である。また、第1データまたは第2データの内容によって、薬液の残存量の計算方法は適宜設定可能である。 Further, for example, in the drug solution administration device 300 according to the embodiment, the first data and the second data include the liquid supply amount at the time of liquid supply and the liquid supply end time, but the present invention is not limited to this. For example, when the liquid feeding operation is performed periodically, the first and second data may be composed of only the liquid feeding amount. Moreover, the calculation method of the residual amount of a chemical | medical solution can be suitably set with the content of 1st data or 2nd data.
 また、例えば、実施形態に係る薬液投与装置300では、他の送液器具としてインスリンペン400を用いたがこれに限定されない。他の送液器具は、薬液投与装置300が備える送液部100以外の器具であって薬液が投与できればよい。 Also, for example, in the liquid medicine administration device 300 according to the embodiment, the insulin pen 400 is used as another liquid delivery device, but the invention is not limited to this. Other liquid delivery devices may be devices other than the liquid delivery unit 100 included in the chemical solution administration device 300 as long as the chemical solution can be administered.
 また、例えば、実施形態に係る薬液投与装置300では、送液部100による送液動作が停止している最中にインスリンペン400を用いる構成としたがこれに限定されない。例えば、送液部100による送液動作中に送液部100のボーラスモードの送液に替えてインスリンペン400を用いる構成とすることも可能である。 For example, in the liquid medicine administration device 300 according to the embodiment, the insulin pen 400 is used while the liquid feeding operation by the liquid feeding unit 100 is stopped. However, the invention is not limited thereto. For example, the insulin pen 400 may be used instead of the bolus mode liquid feeding of the liquid feeding unit 100 during the liquid feeding operation by the liquid feeding unit 100.
 また、例えば、実施形態に係る薬液投与装置300では、前回ボーラスデータとして送液終了時刻を用いたがこれに限定されない。例えば、送液開始時刻や、送液開始時刻と送液終了時刻の中間の時刻を選択することも可能である。 In addition, for example, in the drug solution administration device 300 according to the embodiment, the liquid delivery end time is used as the previous bolus data, but the present invention is not limited to this. For example, it is also possible to select a liquid feeding start time or an intermediate time between the liquid feeding start time and the liquid feeding end time.
 また、例えば、実施形態に係る薬液投与装置300では、前回ボーラスデータの送液量および送液終了時刻を送液部100が備えるモータ32の駆動信号から取得したがこれに限定されない。例えば、コントローラ200から指示された送液量、タイミングを前回ボーラスデータとして扱うことも可能である。 Also, for example, in the liquid medicine administration device 300 according to the embodiment, the liquid supply amount and liquid supply end time of the previous bolus data are obtained from the drive signal of the motor 32 provided in the liquid supply unit 100, but the invention is not limited to this. For example, the amount and timing of liquid delivery instructed from the controller 200 can be handled as previous bolus data.
 本出願は、2015年3月26日に出願された日本国特許出願第2015-064801号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2015-064801 filed on March 26, 2015, the disclosure of which is incorporated by reference in its entirety.
10  注入部、
11  カニューレ、
15  穿刺具、
20  送液ディスポ部、
22  シリンジ、
24  押し子、
25  送りねじ、
30  送液リユース部、
35  駆動部、
40  第2通信部、
50  第2制御部、
51  データ管理部、
100 送液部、
200 コントローラ、
220 表示部、
230 受付部、
250 第1通信部、
260 第1制御部、
261 演算部、
262 記憶部、
300 インスリン投与装置、
400 インスリンペン、
450 第3通信部、
460 第3制御部、
470 電池、
500 インスリン投与アセンブリ。
10 injection part,
11 Cannula,
15 Puncture tool,
20 Dispensing disposable part,
22 syringe,
24 Pusher,
25 Lead screw,
30 Liquid Reuse Reuse Department,
35 drive unit,
40 Second communication unit,
50 second control unit,
51 Data management department,
100 liquid feeding part,
200 controllers,
220 display unit,
230 reception desk,
250 1st communication part,
260 first control unit,
261 arithmetic unit,
262 storage unit,
300 insulin administration device,
400 insulin pen,
450 Third communication unit,
460 third control unit,
470 battery,
500 Insulin administration assembly.

Claims (5)

  1.  使用者の生体内へ薬液を送液する送液部と、
     前記送液部による送液動作を制御する制御部と、
     前記送液部が前記生体内へ送液した前記薬液の送液量に関する第1データ、および前記送液部以外の他の送液器具が前記生体内へ送液した前記薬液の送液量に関する第2データを取得可能な送液データ取得部と、
     前記第1データおよび/または前記第2データに基づいて前記生体内における前記薬液の残存量を計算し、かつ、当該薬液の残存量に基づいて前記生体へ投与すべき前記薬液の送液予定量を計算する演算部と、を有し、
     前記制御部は、前記送液予定量の前記薬液が前記生体へ送液されるように前記送液部の送液動作を制御する、薬液投与装置。
    A liquid feeding section for feeding a chemical into the user's body;
    A control unit for controlling a liquid feeding operation by the liquid feeding unit;
    The first data relating to the amount of the chemical solution delivered by the liquid delivery unit into the living body, and the amount of the chemical solution delivered by the liquid delivery device other than the liquid delivery unit into the living body. A liquid feeding data acquisition unit capable of acquiring the second data;
    Based on the first data and / or the second data, the remaining amount of the drug solution in the living body is calculated, and the planned liquid delivery amount of the drug solution to be administered to the living body based on the remaining amount of the drug solution And an arithmetic unit for calculating
    The said control part is a chemical | medical solution administration apparatus which controls the liquid feeding operation | movement of the said liquid feeding part so that the said chemical | medical solution of the said liquid feeding amount may be sent to the said biological body.
  2.  前記送液データ取得部は、前記他の送液器具から無線通信により送信される前記第2データを取得可能に構成される、請求項1に記載の薬液投与装置。 2. The medicinal liquid administration device according to claim 1, wherein the liquid feeding data acquisition unit is configured to be able to acquire the second data transmitted from the other liquid feeding device by wireless communication.
  3.  前記送液データ取得部は、使用者からの前記第2データの入力を受け付けるデータ入力受付部をさらに有する、請求項1または請求項2に記載の薬液投与装置。 3. The medicinal-solution administration device according to claim 1, wherein the liquid-feeding data acquiring unit further includes a data input receiving unit that receives an input of the second data from a user.
  4.  前記第1データは、前記送液部が前記薬液の送液を終了した際の送液終了時刻を含み、
     前記第2データは、前記他の送液器具が前記薬液の送液を終了した際の送液終了時刻を含む、請求項1~3のいずれか一項に記載の薬液投与装置。
    The first data includes a liquid feeding end time when the liquid feeding unit finishes feeding the chemical liquid,
    The liquid medicine administration device according to any one of claims 1 to 3, wherein the second data includes a liquid delivery end time when the other liquid delivery device finishes feeding the liquid medicine.
  5.  前記送液部は、前記薬液としてのインスリンを一定量で継続的に送液するベーサルモードに対して単位時間当たりの前記インスリンの送液量を一時的に増加して送液するボーラスモードでの送液動作を実施可能に構成されており、
     前記第1データは、前記送液部が、前記ボーラスモードで動作した際に送液した前記インスリンの送液量に関するデータであり、
     前記第2データは、前記送液部による送液動作が停止している最中に、前記他の送液器具が送液した前記インスリンの送液量に関するデータである、請求項1~4のいずれか一項に記載の薬液投与装置。
    In the bolus mode in which the liquid feeding unit temporarily increases the amount of insulin delivered per unit time with respect to the basal mode in which insulin as the drug solution is continuously fed in a constant amount. It is configured to enable liquid feeding operation,
    The first data is data related to the amount of insulin delivered when the fluid delivery unit is operated in the bolus mode,
    5. The data according to claim 1, wherein the second data is data related to the amount of insulin delivered by the other fluid delivery device while the fluid delivery operation by the fluid delivery unit is stopped. The chemical | medical solution administration apparatus as described in any one.
PCT/JP2015/086542 2015-03-26 2015-12-28 Device for administering liquid medicine WO2016151973A1 (en)

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