WO2016151973A1 - Dispositif d'administration de médicament liquide - Google Patents

Dispositif d'administration de médicament liquide 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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WIPO (PCT)
Prior art keywords
liquid
unit
data
liquid feeding
amount
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PCT/JP2015/086542
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English (en)
Japanese (ja)
Inventor
和明 香川
Original Assignee
テルモ株式会社
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Publication of WO2016151973A1 publication Critical patent/WO2016151973A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
    • A61M5/172—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body 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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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Le problème décrit par la présente invention est de fournir un dispositif pour administrer un médicament liquide, un médicament liquide pouvant être administré dans une quantité d'alimentation appropriée à un corps vivant, ladite quantité d'alimentation étant déterminée en prenant la quantité restante du médicament liquide, qui a été fourni par un autre dispositif d'alimentation en liquide, etc., au corps vivant, en prenant en considération et en fonction de la quantité restante. La solution selon l'invention concerne un dispositif (300) pour administrer un médicament liquide, qui comprend : une partie d'alimentation en liquide (100) qui fournit un médicament liquide au corps vivant d'un utilisateur ; une deuxième partie de commande (50) qui commande l'opération d'alimentation de la partie d'alimentation en liquide ; une partie d'acquisition de données d'alimentation en liquide (une deuxième partie de communication (40) et la deuxième partie de commande (50)) qui est capable d'acquérir des premières données, relatives à la quantité d'alimentation du médicament liquide fourni par la partie d'alimentation en liquide au corps vivant de l'utilisateur, et des secondes données relatives à la quantité d'alimentation du médicament liquide ayant été fourni par un dispositif d'alimentation en liquide autre que la partie d'alimentation en liquide au corps vivant ; et une partie de calcul (261) qui calcule la quantité du médicament liquide restant dans le corps vivant sur la base des premières données et/ou des secondes données, puis calcule une quantité d'alimentation programmée du médicament liquide à administrer au corps vivant sur la base de la quantité restante de ce dernier. La partie de commande commande le fonctionnement de la partie d'alimentation en liquide de telle sorte que le médicament liquide est acheminé dans le corps vivant dans la quantité d'alimentation programmée calculée par la partie de calcul.
PCT/JP2015/086542 2015-03-26 2015-12-28 Dispositif d'administration de médicament liquide WO2016151973A1 (fr)

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CN111601628A (zh) * 2018-03-29 2020-08-28 泰尔茂株式会社 输液装置以及注射器泵
US11896797B2 (en) 2017-12-12 2024-02-13 Bigfoot Biomedical, Inc. Pen cap for insulin injection pens and associated methods and systems
US11904145B2 (en) 2017-12-12 2024-02-20 Bigfoot Biomedical, Inc. Diabetes therapy management systems, methods, and devices
US11931549B2 (en) 2017-12-12 2024-03-19 Bigfoot Biomedical, Inc. User interface for diabetes management systems and devices
US11944465B2 (en) 2017-12-12 2024-04-02 Bigfoot Biomedical, Inc. Monitor user interface for diabetes management systems including flash glucose
US11957884B2 (en) 2017-12-12 2024-04-16 Bigfoot Biomedical, Inc. Insulin injection assistance systems, methods, and devices

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11896797B2 (en) 2017-12-12 2024-02-13 Bigfoot Biomedical, Inc. Pen cap for insulin injection pens and associated methods and systems
US11904145B2 (en) 2017-12-12 2024-02-20 Bigfoot Biomedical, Inc. Diabetes therapy management systems, methods, and devices
US11918789B2 (en) 2017-12-12 2024-03-05 Bigfoot Biomedical, Inc. Therapy management systems, methods, and devices
US11931549B2 (en) 2017-12-12 2024-03-19 Bigfoot Biomedical, Inc. User interface for diabetes management systems and devices
US11944465B2 (en) 2017-12-12 2024-04-02 Bigfoot Biomedical, Inc. Monitor user interface for diabetes management systems including flash glucose
US11957884B2 (en) 2017-12-12 2024-04-16 Bigfoot Biomedical, Inc. Insulin injection assistance systems, methods, and devices
JP7512203B2 (ja) 2017-12-12 2024-07-08 ビッグフット バイオメディカル インコーポレイテッド 治療支援情報及び／又は追跡装置並びに関連する方法及びシステム
CN111601628A (zh) * 2018-03-29 2020-08-28 泰尔茂株式会社 输液装置以及注射器泵

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