WO2015141562A1 - Pompe d'administration de fluide - Google Patents

Pompe d'administration de fluide Download PDF

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Publication number
WO2015141562A1
WO2015141562A1 PCT/JP2015/057382 JP2015057382W WO2015141562A1 WO 2015141562 A1 WO2015141562 A1 WO 2015141562A1 JP 2015057382 W JP2015057382 W JP 2015057382W WO 2015141562 A1 WO2015141562 A1 WO 2015141562A1
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WO
WIPO (PCT)
Prior art keywords
upper limit
concentration
value
target
drug
Prior art date
Application number
PCT/JP2015/057382
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English (en)
Japanese (ja)
Inventor
裕子 大澤
長谷川　英司
Original Assignee
テルモ株式会社
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Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2015141562A1 publication Critical patent/WO2015141562A1/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
    • A61M5/168—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
    • A61M5/1723—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 using feedback of body parameters, e.g. blood-sugar, pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M2005/14208—Pressure infusion, e.g. using pumps with a programmable infusion control system, characterised by the infusion program
    • 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
    • A61M2005/14288—Infusion or injection simulation
    • A61M2005/14292—Computer-based infusion planning or simulation of spatio-temporal infusate distribution
    • 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
    • A61M2005/14288—Infusion or injection simulation
    • A61M2005/14296—Pharmacokinetic models

Definitions

  • the present invention relates to a liquid delivery pump used in the medical field for delivering a medicine into a patient's body.
  • a drug such as intravenous anesthetic
  • a medical setting such as an intensive care unit
  • the amount of fluid delivered is adjusted appropriately for a long period of time depending on the technique to be applied and the patient's symptoms. It is necessary to carry out liquid feeding.
  • infusion pumps and syringe pumps as devices for accurately delivering a medicine over a long period of time with a set amount of liquid to be delivered. Setting of the amount of liquid delivery is performed by a medical worker using an infusion pump or a syringe pump.
  • the upper limit of the amount of liquid delivered is different. Therefore, when delivering a drug, it is necessary to appropriately adjust the liquid delivery amount so as not to exceed the upper limit set for each type of drug, depending on whether or not the efficacy of the drug is expressed. There is. Conventionally, the adjustment of the liquid feeding amount has been manually performed by medical personnel. For this reason, there is a problem in that the adjustment of the liquid feeding amount depending on whether or not the efficacy of the drug is expressed is not always performed at an appropriate timing.
  • TCI pump Target Controlled Infusion
  • TCI pump Target Controlled Infusion
  • a target blood concentration is set instead of the delivery volume.
  • the TCI pump automatically adjusts the amount of liquid delivered so that the blood concentration of the delivered medicine reaches the target concentration and is maintained.
  • the blood concentration of the medicine is calculated based on the simulation from the amount of medicine delivered.
  • the TCI pump when used, there is a possibility that the liquid will be fed with a liquid feeding amount that exceeds the upper limit value of the liquid feeding amount determined according to the type of the medicine. For example, when the target blood concentration was set higher than the allowable blood concentration at the start of drug delivery, the upper limit was exceeded in order to quickly reach the target blood concentration. There is a possibility that the drug will be delivered in the amount delivered.
  • Some TCI pumps can set an upper limit value of the liquid delivery amount in order to prevent delivery of a medicine at a liquid delivery amount exceeding the upper limit value. However, it does not have a function to switch the upper limit value of the liquid feeding amount depending on whether or not the efficacy of the drug is expressed, and the liquid is not always delivered at an appropriate liquid feeding amount. There is also a problem that the upper limit value of the liquid feeding amount is set erroneously.
  • the present invention has been made to solve the above-described problems, and at the time of delivering a medicine, the medicine is delivered with an appropriate amount of medicine that does not exceed a predetermined upper limit defined for each kind of medicine.
  • An object is to provide a liquid feed pump capable of liquid.
  • the liquid delivery pump for achieving the above object is a liquid delivery pump for delivering the medicine while simulating the concentration of the delivered medicine in the living body, and the liquid delivery pump for delivering the medicine
  • An observation unit that observes fluctuations in vitals, a calculation unit that calculates the concentration of the medicine in the living body based on the amount of the delivered medicine, and a value observed by the observation part becomes a predetermined target value
  • a vital determination unit that determines whether or not it has reached, an upper limit introduction flow rate of the drug, an upper limit maintenance flow rate of the drug, and a target concentration of blood concentration or effect site concentration of the drug calculated by the calculation unit;
  • a storage unit for storing the target value; a receiving unit for receiving input of the target concentration and the target value; and an upper limit value of the liquid delivery amount of the medicine according to a determination result of the vital determination unit.
  • Up to the upper limit introduction flow rate Is an upper limit value switching unit that switches to the upper limit maintenance flow rate, and an adjustment unit that adjusts the amount of the drug delivered in a range that does not exceed the upper limit value so that the blood concentration or the effect site concentration maintains the target concentration And having.
  • the present invention it is possible to observe changes in vitals of a living body to which a medicine is fed. Then, it can be determined whether or not the observed vital value has reached a predetermined target value. Furthermore, it is possible to switch the upper limit value of the drug delivery amount according to the determination result of whether or not the observed vital value has reached a predetermined target value. Therefore, according to the present invention, at the time of drug delivery, an appropriate liquid delivery amount that does not exceed a predetermined upper limit value determined depending on whether or not the efficacy of the drug is expressed for each type of drug. It is possible to deliver a medicine.
  • the upper limit value switching unit can be configured to switch to the maintenance flow rate.
  • the upper limit value switching unit can be configured to switch to the upper limit introduction flow rate.
  • the liquid feeding can be configured to stop the liquid feeding when the observed vital value reaches a predetermined limit value.
  • the target concentration is determined depending on whether the observed vital value has reached a predetermined target value and whether the calculated concentration of the medicine in the living body has reached the predetermined target concentration.
  • the reception unit when storing the upper limit introduction flow rate and the upper limit maintenance flow rate, can be configured to limit the acceptance of the upper limit maintenance flow rate exceeding the upper limit introduction flow rate. With this configuration, since the upper limit maintenance flow rate exceeding the upper limit introduction flow rate can be prevented from being stored erroneously, safety is improved.
  • the accepting unit can be configured to accept the input of the target value during liquid feeding. With this configuration, since the target value can be changed according to the situation, safety and convenience are further improved.
  • the accepting unit can be configured to accept the input of the target concentration during liquid feeding. With this configuration, since the target concentration can be changed according to the situation, safety and convenience are further improved.
  • the upper limit value switching unit can be configured to switch the upper limit value of the liquid feeding amount when the observed vital value is included within a predetermined allowable range based on the target value.
  • it can be configured to have a notification unit that notifies that the upper limit value of the amount of liquid to be delivered is switched.
  • the observed vital is a bispectral index.
  • it can be suitably used for feeding anesthetics such as intravenous anesthetics.
  • FIG. It is a figure which shows the change of the change of the bispectral index, and the blood concentration and effective site concentration of the delivered medicine, and when the liquid is delivered using the syringe pump according to the first embodiment of the present invention.
  • FIG. It is an external appearance front view for demonstrating the display part of the syringe pump which concerns on 1st Embodiment of this invention, Comprising: It is a figure in the middle of liquid feeding using a syringe pump.
  • FIG. It is a figure which shows the change of the change of the bispectral index, and the blood concentration and effective site concentration of the delivered medicine, and when the liquid is delivered using the syringe pump according to the second embodiment of the present invention.
  • FIG. It is a general
  • FIG. 1 It is a figure for demonstrating operation
  • FIG. It is a figure which shows the change of the change of the bispectral index, and the blood concentration and effective site concentration of the delivered medicine, and when the liquid is delivered using the syringe pump according to the third embodiment of the present invention.
  • FIG. It is a figure which shows the change of the change of the bispectral index, and the blood concentration and effective site concentration of the delivered medicine, and when the liquid is delivered using the syringe pump according to the fourth embodiment of the present invention.
  • FIG. It is an external appearance front view for demonstrating the display part of the syringe pump which concerns on 5th Embodiment of this invention, Comprising: It is a figure which shows the example of a display at the time of selecting the density
  • the syringe pump 1 according to the first embodiment of the present invention shown in FIG. 1 and FIG. 2 delivers a drug into a patient's body for a long time in an intensive care unit such as an ICU, CCU, or NICU. It is a liquid feed pump used for liquefying.
  • the syringe pump 1 can send various drugs including intravenous anesthetics into the patient's body.
  • intravenous anesthetics include propofol, mitazolam, and remifentanil.
  • an upper limit is set for each type of medicine in the amount of medicine delivered to the body of a patient.
  • the liquid feeding amount means a flow rate, and for example, ml / kg / second, ml / kg / hour, or the like is used as a unit.
  • the upper limit of the amount of liquid to be introduced (hereinafter referred to as the upper limit introduction flow rate) until the effect of the delivered drug is expressed, and the amount of the liquid that maintains the effect of the drug after the effect of the drug is expressed
  • the upper limit value (hereinafter, the upper limit maintenance flow rate) is different.
  • the upper limit maintenance flow rate is smaller than the upper limit introduction flow rate.
  • a document (hereinafter referred to as a drug package insert) that describes how to use the drug, precautions, and the like is attached to each drug.
  • the upper limit introduction flow rate and the upper limit maintenance flow rate are described in the medicine package insert.
  • the expression may be described in terms of an appropriate value for the liquid supply amount, not the expression for the upper limit value of the liquid supply amount, but it is substantially the same.
  • the drug delivery must be performed with an appropriate liquid delivery amount that does not exceed the upper limit introduction flow rate or the upper limit maintenance flow rate.
  • the syringe pump 1 switches the upper limit value of the liquid feeding amount to the upper limit introduction flow rate or the upper limit maintenance flow rate determined for each type of the drug according to whether or not the efficacy of the drug is manifested, so The drug is delivered in liquid volume.
  • the syringe pump 1 uses a bispectral index for determining whether or not the efficacy of the drug is expressed. .
  • the bispectral index is a value calculated based on the electroencephalogram.
  • the bispectral index has a value in the range of 0-100. It is known that there is a certain relationship between the value of the bispectral index and the expression state of the efficacy of the drug. For example, as the relationship between the value of the bispectral index and the state of the development of the anesthetic effect, the closer the bispectral index value is to 100, the more the patient is awake, and the lower the bispectral index value, the more the anesthesia is. It is known to be in effect. Furthermore, it is known that, for example, there is the following relationship, depending on the patient to whom the anesthetic is administered and the drug to be administered.
  • the bispectral index value when the bispectral index value is 70 to 80 or more, it is known that some patients may return to an awakened state during the procedure without continuing an unconscious state. . It is also known that when the value of the bispectral index is 50 to 60 or less, an unconscious state persists in most patients, and there is almost no awakening during the procedure. In addition, if the bispectral index value is below 20-30, the anesthesia is too effective, and there is no possibility of waking up during the procedure, but the patient may be at risk. It has been known.
  • the relationship between the value of the bispectral index and the expression state of the efficacy of the drug is not limited to the sedatives in the above-described examples, but is also observed in various anesthetics.
  • the syringe pump 1 determines whether or not the efficacy of the drug is manifested by whether or not the value of the bispectral index has reached a predetermined target value, and switches the upper limit value of the liquid delivery amount. I do.
  • the syringe pump 1 presses a syringe pusher 202 of a syringe 200 as a medicine storage container filled with a medicine in the T direction so that the medicine in the syringe body 201 is transferred to a tube 203.
  • the liquid is accurately delivered to the patient via the indwelling needle 204.
  • the syringe body 201 of the syringe 200 is set in the syringe pump 1 so as not to move by the clamp 5.
  • the syringe pump 1 has a main body cover 2.
  • the main body cover 2 is integrally formed of a molded resin material having chemical resistance. Thereby, the main body cover 2 has a splash-proof processing structure. Due to the splash-proof treatment structure, even if a drug or the like is applied, it can be prevented from entering the syringe pump 1.
  • the reason for having a splash-proof treatment structure is that the medicine in the syringe body 201 may spill, the drip solution disposed above may spill out, or disinfectant used in the vicinity may scatter and adhere.
  • the main body cover 2 has an upper portion 2A and a lower portion 2B.
  • a display unit 3 and an operation panel unit 4 are arranged in the upper part 2A.
  • a syringe setting unit 6 and a syringe pusher drive unit 7 for pushing the syringe pusher 202 are arranged.
  • the display unit 3 is an image display device capable of color display.
  • the display unit 3 can be configured by a color liquid crystal display device, for example.
  • the display unit 3 can display not only information notation in Japanese but also information in a plurality of foreign languages as necessary.
  • the display unit 3 is located at the upper left position of the upper portion 2 ⁇ / b> A of the main body cover 2 and above the syringe setting unit 6 and the syringe pusher driving unit 7.
  • the operation panel unit 4 is disposed on the right side of the display unit 3 in the upper part of the main body cover 2.
  • a power ON / OFF button 4A, an operation indicator 4F, and operation buttons are arranged on the operation panel unit 4.
  • FIG. 1 and FIG. 2 show an example in which four minimum required fast-forward switch buttons 4B, start switch buttons 4C, stop switch buttons 4D, and menu selection buttons 4E are arranged as operation buttons.
  • the syringe setting unit 6 and the syringe pusher driving unit 7 are arranged side by side along the X direction.
  • the syringe setting unit 6 can select and fix a plurality of different types of syringes 200, 300, and 400, which will be described later with reference to FIG.
  • the syringe setting unit 6 includes a storage unit 8 that stores the syringe body 201 and a clamp 5.
  • the accommodating portion 8 is a concave portion having a substantially semicircular cross section and is formed along the X direction.
  • a tube fixing portion 9 for detachably holding the tube 203 is formed on the wall portion at the end of the housing portion 8.
  • the clamp 5 When removing the syringe 200 from the syringe setting unit 6 by operating the clamp 5, the clamp 5 is pulled in the Y1 direction (frontward direction) against the force of a spring (not shown) and turned 90 degrees in the R1 direction.
  • the syringe body 201 can be detached from the housing portion 8 after being fixed by the clamp 5. Further, when the clamp 5 is operated and the syringe 200 is attached to the syringe setting unit 6, the clamp 5 is pulled in the Y1 direction against the force of the spring (not shown) and turned 90 degrees in the R2 direction. By returning to the Y2 direction, the syringe body 201 can be housed in the housing portion 8 and fixed by the clamp 5.
  • the right end portion 8E of the accommodating portion 8 of the syringe setting portion 6 is partially cut away so that the clamp 5 can fix the syringe with the accommodating amount of 2.5 mL, 5 mL, 10 mL, 20 mL, 30 mL, and 50 mL. It has become.
  • the syringe pusher 202 When the syringe body 201 is housed and fixed in the housing portion 8, the syringe pusher 202 is disposed in the syringe pusher drive portion 7.
  • the syringe pusher drive unit 7 has a slider 10. The slider 10 pushes the pusher flange 205 of the syringe pusher 202 little by little along the T direction relative to the syringe body 201 in accordance with a command from the control unit 100 shown in FIGS. 2 and 8.
  • the X direction, the Y direction, and the Z direction in FIGS. 1 and 2 are orthogonal to each other, and the Z direction is the vertical direction.
  • a BIS monitor 500 is connected to the syringe pump 1 via a cable 501.
  • the BIS monitor 500 observes an electroencephalogram via an electroencephalogram measurement probe (not shown) attached to the patient's head. Then, a bispectral index is calculated based on the observed electroencephalogram. The value of the bispectral index can be calculated by a known method. The calculated bispectral index value is input to the control unit 100 of the syringe pump 1 via the cable 501 as described later.
  • FIG. 3 shows a display content example of the display unit 3.
  • the display content example of the display unit 3 is an example and is not particularly limited.
  • FIG. 7 is a perspective view showing an example of the above-described multiple types of syringes.
  • 1 and 2 show an example in which the syringe 200 having the largest amount of medicine is fixed.
  • the syringe 200 having the largest amount of medicine is provided with a syringe main body 201 and a syringe pusher 202, and the syringe main body 201 has a main body flange 209, and the syringe pusher. 202 has a pusher flange 205.
  • the syringe main body 201 is formed with a medicine scale 210.
  • One end of a flexible tube 203 is detachably connected to the outlet 211 of the syringe body 201.
  • the syringe 300 having a medium amount of medicine has a syringe main body 301 and a syringe pusher 302, and the syringe main body 301 has a main body flange 309.
  • the child 302 has a pusher flange 305.
  • the syringe body 301 is formed with a medicine scale 310.
  • One end of a flexible tube 203 is detachably connected to the outlet 311 of the syringe body 301.
  • the syringe 400 with the smallest amount of medicine is provided with a syringe body 401 and a syringe pusher 402.
  • the syringe body 401 has a body flange 409, and the syringe pusher.
  • Reference numeral 402 has a pusher flange 405.
  • the syringe body 401 is formed with a drug scale 410.
  • One end of a flexible tube 203 is detachably connected to the outlet 411 of the syringe body 401.
  • the syringe 200 shown in FIG. 7A has, for example, a medicine capacity of 50 mL
  • the syringe 300 shown in FIG. 7B has, for example, a medicine capacity of 10 mL, 20 mL, and 30 mL
  • the syringe 400 shown in FIG. The syringes 300 and 400 can be housed and fixed in the housing portion 8 in the same manner as the syringe 200 shown in FIGS. 1 and 2.
  • the syringe pump 1 has a control unit (computer) 100 that performs overall operation determination and control.
  • the control unit 100 is, for example, a one-chip microcomputer, and includes a ROM (Read Only Memory) 101, a RAM (Random Access Memory) 102, a nonvolatile memory 103, and a clock 104.
  • the clock 104 can correct the current time by a predetermined operation, and can acquire the current time, measure the elapsed time of a predetermined liquid feeding operation, measure the reference time of liquid feeding speed control, and the like.
  • the control unit 100 shown in FIG. 8 is connected to a power ON / OFF button 4A and a switch 111.
  • the switch 111 supplies power to the control unit 100 from either the power converter unit 112 or the rechargeable battery 113 by switching between the power converter unit 112 and the rechargeable battery 113 such as a lithium ion battery.
  • the power converter unit 112 is connected to a commercial AC power source 115 via an outlet 114.
  • a pair of detection switches 120 and 121 are arranged in the accommodating portion 8.
  • the detection switches 120 and 121 detect whether or not the syringe body 201 of the syringe 200 is correctly arranged in the storage unit 8 and notify the control unit 100 of it.
  • the clamp sensor 122 notifies the control unit 100 whether or not the syringe body 201 is reliably clamped by the clamp 5 by detecting the position state of the clamp 5.
  • the feed screw 135 is rotated to move the slider 10 in the T direction.
  • the slider 10 presses the syringe pusher 202 in the T direction, and accurately delivers the medicine in the syringe main body 201 shown in FIG. 2 to the patient P through the tube 203 via the indwelling needle 204. .
  • the fast forward switch button 4B, the start switch button 4C, the stop switch button 4D, and the menu selection button 4E are electrically connected to the control unit 100.
  • the start switch button 4 ⁇ / b> C is pressed, a liquid feed start control signal is input to the control unit 100.
  • the stop switch button 4D is pressed, a liquid feed stop control signal is input to the control unit 100.
  • the display unit driver 130 is electrically connected to the control unit 100.
  • the display unit driver 130 drives the display unit 3 according to instructions from the control unit 100 to display various information on the display unit 3.
  • the speaker 131 is electrically connected to the control unit 100.
  • the speaker 131 notifies various alarm contents by voice according to a command from the control unit 100.
  • the control unit 100 has a function as a calculation unit that calculates the concentration of the medicine in the living body based on the amount of the medicine delivered into the living body from the start of the feeding.
  • the amount of the medicine delivered into the living body from the start of feeding is, for example, the inner diameter of the syringe body 201 of the syringe 200 and the movement amount of the slider 10 moved in the T direction by the feed screw 135 from the start of feeding. It can be calculated by multiplying.
  • the concentration of the drug in the living body is calculated by simulation.
  • the simulation is performed using a 3-compartment model based on pharmacokinetics, but is not limited to this.
  • the concentration is calculated by dividing the body into three parts (hereinafter, compartments).
  • One of the three compartments is a compartment that models blood.
  • the other two compartments are obtained by modeling a tissue rich in blood flow such as muscle and a tissue such as fat having rough blood flow in the living body.
  • the drug is administered in a compartment that models blood. Then, the drug moves at a predetermined transition speed between the compartment modeling the blood and the other two compartments.
  • the drug is excreted outside the body at a predetermined excretion rate through a compartment modeling blood.
  • the concentration of the delivered drug in each compartment including the blood concentration, based on the information on the patient to whom the drug is delivered and the relationship between the amount of delivered drug, the transfer rate, and the excretion rate. Can do.
  • the effect site concentration which is the concentration of the site to which the drug is applied, can also be calculated.
  • a neuromuscular junction can be considered as an effect site.
  • the liquid delivery amount is calculated based on the difference between the blood concentration or effect site concentration of the drug calculated in this way and the set target concentration. If the upper limit value is exceeded, the liquid delivery amount is the upper limit value.
  • the nonvolatile memory 103 stores the upper limit introduction flow rate and the upper limit maintenance flow rate for each type of medicine.
  • the non-volatile memory 103 stores a target value of the bispectral index. Further, the nonvolatile memory 103 stores a target density. The target concentration is stored in units of mcg / ml, for example.
  • the non-volatile memory 103 stores information on a patient to be fed and the type of medicine to be fed. The stored patient information includes, for example, sex, age, height, weight, and the like. Further, the non-volatile memory 103 stores an upper limit value of the liquid feeding amount switched by the control unit 100 as will be described later.
  • the control unit 100 is electrically connected to the BIS monitor 500 via the external device connection terminal 160.
  • the bispectral index value is input from the BIS monitor 500 to the control unit 100.
  • the control unit 100 further serves as a reception unit that receives input of information such as the upper limit introduction flow rate, the upper limit maintenance flow rate, the target value, the target concentration, the patient information, and the type of medicine to be delivered, which are stored in the nonvolatile memory 103. It has a function.
  • the control unit 100 stores the received information in the nonvolatile memory 103.
  • the control unit 100 accepts input even during drug delivery. Therefore, the target value and the target concentration stored in the nonvolatile memory 103 can be changed during the delivery of the medicine.
  • the control unit 100 checks the input upper limit introduction flow rate and the upper limit maintenance flow rate, and limits the acceptance of unauthorized input. Specifically, the control unit 100 checks the magnitude relationship between the upper limit introduction flow rate and the upper limit maintenance flow rate. When the upper limit maintenance flow rate exceeds the upper limit introduction flow rate, the input upper limit introduction flow rate and upper limit maintenance flow rate are not stored in the nonvolatile memory 103.
  • Input of information on the upper limit introduction flow rate and the upper limit maintenance flow rate to the control unit 100 can be performed by various methods.
  • the upper limit introduction flow rate and the upper limit maintenance flow rate can be input for each type of medicine.
  • a computer 141 such as a desktop computer and the control unit 100 are connected via a communication port 140. Then, by operating the computer 141, the upper limit introduction flow rate and the upper limit maintenance flow rate can be input to the control unit 100 via the communication port 140 for each type of medicine.
  • the computer 141 may be connected to the medicine database 150 as shown in FIG.
  • the upper limit introduction flow rate and the upper limit maintenance flow rate can be collectively stored as a drug library for each type of drug.
  • the upper limit introduction flow rate and the upper limit maintenance flow rate stored for each type of drug in the drug database 150 can be input to the control unit 100 via the communication port 140.
  • the drug library may record information on drugs other than the upper limit introduction flow rate and the upper limit maintenance flow rate. For example, drug manufacturers and contraindication information may be recorded for each type of drug. Such information can also be input to the control unit 100 through the communication port 140 together with the upper limit introduction flow rate and the upper limit maintenance flow rate.
  • the drug library can be generated collectively for each hospital or ward and stored in the drug database 150.
  • Information on the patient to be delivered, the type of medicine to be delivered, the target value of the bispectral index, and the target concentration are operated by operating the operation buttons of the operation panel unit 4 according to the display content of the display unit 3. Can be entered.
  • FIGS. 4A and 4B show examples of display contents of the display unit 3 when inputting information on a patient to be fed.
  • information such as the sex, age, height, and weight of the patient to be fed can be input.
  • FIG. 5 shows a display content example of the display unit 3 when inputting the type of medicine to be delivered.
  • 6A and 6B show examples of display contents of the display unit 3 when inputting the target value and target density of the bispectral index.
  • the target value of the bispectral index and the target concentration of blood concentration can be input.
  • the control unit 100 starts liquid feeding when the start switch button 4C is pressed and a liquid feeding start control signal is input. Further, when the stop switch button 4D is pressed and a liquid feed stop control signal is input, the control unit 100 stops liquid feeding.
  • the control unit 100 functions as a vital determination unit that determines whether or not the value of the bispectral index input from the BIS monitor 500 has reached the target value, and the upper limit value switching that switches the upper limit value of the liquid feeding amount A function as a unit and a function as an adjustment unit for adjusting a liquid feeding amount.
  • the non-volatile memory uses the upper limit introduction flow rate stored in the non-volatile memory 103 as the upper limit value of the drug supply amount in accordance with the type of the drug to be sent stored in the non-volatile memory 103. 103.
  • step S102 it is determined whether or not a liquid feed end condition is satisfied.
  • the liquid feeding end condition is satisfied, the liquid feeding is finished. At least when the stop switch button 4D is pressed and an input of a control signal for the end of liquid feeding is received, the liquid feeding end condition is satisfied.
  • step S103 the upper limit value stored in the non-volatile memory 103 is not exceeded, and the blood concentration of the drug after liquid feeding is maintained at the target concentration stored in the non-volatile memory 103.
  • the blood concentration of the drug after feeding can be calculated by simulation based on the amount of the medicine to be sent, the patient information stored in the nonvolatile memory 103, the kind of the medicine to be sent, and the like. it can.
  • the medicine is fed by the slider 10 pressing the syringe pusher 202 in the T direction (see FIGS. 1 and 2).
  • the slider 10 is moved by driving the motor driver 134 of the syringe pusher drive unit 7 (see FIG. 8).
  • step S104 it is determined whether or not the bispectral index value input from the BIS monitor 500 has reached the target value. If it is determined that the target value has not been reached, the process returns to step S102. If it is determined that the target value has been reached, the process proceeds to step S105.
  • step S105 the upper limit value of the liquid feeding amount is switched from the upper limit introduction flow rate to the upper limit maintenance flow rate.
  • Switching of the upper limit value is performed by rewriting the upper limit value stored in the nonvolatile memory 103. That is, the upper limit maintenance flow rate stored in the non-volatile memory 103 is stored in the non-volatile memory 103 as the upper limit value of the drug delivery amount in accordance with the type of the drug to be sent stored in the non-volatile memory 103. In this way, the upper limit value is switched.
  • the control unit 100 notifies that the upper limit value has been switched after the upper limit value has been switched.
  • Various methods can be considered for the notification. For example, it is possible to notify that the upper limit value has been switched by issuing a command to the speaker 131 to emit a buzzer sound. It is also possible to issue a command to the display unit driver 130 to display and notify the display unit 3 of text or video indicating that the upper limit has been switched.
  • step S106 it is determined whether or not the liquid feed end condition is satisfied, as in step S102.
  • the liquid feeding is finished.
  • step S ⁇ b> 107 the upper limit value stored in the non-volatile memory 103 is not exceeded, and the blood concentration of the drug after liquid feeding is maintained at the target concentration stored in the non-volatile memory 103.
  • the blood concentration of the drug after liquid feeding can be calculated by simulation in the same manner as in step S103.
  • the medicine is fed by pressing the syringe pusher 202 in the same manner as in step S103.
  • step S108 it is determined whether or not the bispectral index value input from the BIS monitor 500 has reached the target value stored in the nonvolatile memory 103. If it is determined that the target value has been reached, the process returns to step S106. If it is determined that the target value has not been reached, the process proceeds to step S109.
  • step S109 the upper limit value of the liquid feeding amount is switched from the upper limit maintenance flow rate to the upper limit introduction flow rate. That is, the upper limit introduction flow rate stored in the non-volatile memory 103 is stored in the non-volatile memory 103 as the upper limit value of the drug delivery amount in accordance with the type of the drug to be sent stored in the non-volatile memory 103. . After switching the upper limit value, control unit 100 notifies that the upper limit value has been switched, and returns to step S102.
  • FIG. 10 is a graph showing an example of changes in the concentration of the drug in the living body when the drug is fed using the syringe pump 1.
  • d0 represents blood concentration
  • d1 represents effect site concentration
  • D1 represents target concentration.
  • b0 shows the value of a bispectral index
  • B1 shows the target value of a bispectral index.
  • T0 indicates a liquid feeding start time
  • T1 indicates a time when the blood concentration reaches the target concentration D1
  • T2 indicates a time when the value of the bispectral index b0 reaches the target value B1.
  • the syringe pump 1 starts liquid feeding at the time T0 with the upper limit introduction flow rate as the upper limit value of the liquid feeding amount.
  • the blood concentration d0 reaches the target concentration D1 at time T1.
  • the blood concentration d0 is maintained at the target concentration.
  • the bispectral index value b0 reaches the target value B1.
  • the upper limit value of the liquid feeding amount is switched from the upper limit introduction flow rate to the upper limit maintenance flow rate.
  • FIGS. 11A to 11C are diagrams showing an example of transition of display contents of the display unit 3 while the medicine is being delivered.
  • FIG. 11A shows a display example of the display unit 3 immediately after the start of liquid feeding.
  • FIG. 11B shows a display example of the display unit 3 when the value of the bispectral index reaches the target value.
  • FIG. 11C shows a display example of the display unit 3 after the bispectral index value reaches the target value.
  • the display unit 3 displays the target value B1 and the target concentration D1 stored in the nonvolatile memory 103.
  • the current value of the bispectral index b0 is displayed.
  • the display unit 3 displays a prediction line for the blood concentration d0 of the drug and a prediction line for the effect site concentration d1 calculated based on the simulation while the drug is being delivered.
  • the axis T indicates time and the axis D indicates concentration.
  • a region d1 ′ filled with black represents a transition history of the effect site concentration d1 from the start of liquid feeding to the present time.
  • control unit 100 and the computer 141 are connected via the communication port 140.
  • the computer 141 is operated to input the drug library information stored in the drug database 150 to the control unit 100 via the communication port 140.
  • the upper limit introduction flow rate and the upper limit maintenance flow rate recorded in the medicine library are stored in the nonvolatile memory 103 for each kind of medicine.
  • the BIS monitor 500 is connected to the syringe pump 1 via the cable 501. Then, an electroencephalogram measurement probe (not shown) is attached to the patient's head.
  • the syringe 200 is set in the syringe pump 1.
  • the syringe pump 1 is set by the method described above using the clamp 5.
  • the indwelling needle 204 with which the tube 203 was connected is inserted in a patient.
  • various information is input using the display unit 3 and the operation panel unit 4.
  • sex, age, height, and weight are input as patient information.
  • the type of medicine to be fed is input.
  • the target value of the bispectral index and the target concentration of the blood concentration are input.
  • the start switch button 4C is pressed to start feeding the medicine into the patient's body. Switching of the upper limit value of the liquid feeding amount and adjustment of the liquid feeding amount are performed by the control unit 100 according to the flowchart shown in FIG. The liquid feeding is performed until the liquid feeding end condition described above is satisfied.
  • the target value of the bispectral index can be changed during feeding. That is, the target value can be changed when the drug effect is not manifested even though the value of the bispectral index has reached the target value.
  • the target value may be changed when the efficacy of the drug is observed before the bispectral index value reaches the target value.
  • the target value can be changed by operating the operation panel unit 4 in accordance with the display on the display unit 3.
  • the target concentration of blood concentration can be changed during liquid feeding.
  • the target concentration can be changed when the value of the bispectral index does not reach the target value even though the effect site concentration reaches the target concentration.
  • the target concentration may be changed when the value of the bispectral index reaches the target value before the effect site concentration reaches the target concentration.
  • the target density can be changed by operating the operation panel unit 4 in accordance with the display on the display unit 3.
  • the present embodiment it is possible to observe the vital fluctuation of the living body to which the medicine is fed. Then, it can be determined whether or not the observed vital value has reached a predetermined target value. Furthermore, it is possible to switch the upper limit value of the drug delivery amount according to the determination result of whether or not the observed vital value has reached a predetermined target value. Therefore, according to this embodiment, at the time of drug delivery, an appropriate liquid delivery amount that does not exceed a predetermined upper limit value determined depending on whether or not the efficacy of the drug is expressed for each type of drug. It is possible to feed the drug with.
  • the upper limit introduction flow rate when the observed vital value reaches the target value, the upper limit of the liquid delivery amount when the medicine is delivered The value can be switched from the upper limit introduction flow rate to the upper limit maintenance flow rate. Thereby, in the state where the effect of the medicine is expressed in a specific part of the living body, the medicine can be fed with a liquid feeding amount that does not exceed the upper limit value of the allowable liquid feeding amount.
  • the upper limit maintenance flow rate when the upper limit maintenance flow rate is set as the upper limit value, when the observed vital value no longer satisfies the target value, The upper limit value can be switched from the upper limit maintenance flow rate to the upper limit introduction flow rate. As a result, when the effect of the drug is changed to a state where it is not expressed, the target concentration of the blood concentration can be changed to quickly return to the state where the drug effect is expressed. it can.
  • the amount of liquid delivered when the medicine is delivered is adjusted so that the blood concentration is maintained at the target concentration.
  • the blood concentration is kept constant without exceeding a predetermined target concentration, so that safety is improved.
  • the reception of the upper limit maintenance flow rate exceeding the upper limit introduction flow rate is limited.
  • the present embodiment it is possible to accept the input of the target value of the bispectral index during liquid feeding. Thereby, since the target value can be changed according to the situation, safety and convenience are further improved.
  • the present embodiment it is possible to accept the input of the target concentration during the liquid feeding. Thereby, since the target density can be changed according to the situation, safety and convenience are further improved.
  • the bispectral index it is determined by the bispectral index whether or not the efficacy of the drug is expressed.
  • it can use suitably for liquid feeding of anesthetics, such as a vein anesthetic.
  • the control unit 100 switches the upper limit value depending on whether or not the bispectral index value has reached the target value.
  • the bispectral index value is set to a predetermined allowable value based on the target value.
  • the upper limit value may be switched according to whether or not it falls within the range.
  • the control unit 100 determines that the value of the bispectral index is (50.0-50.0 ⁇ 0.05) or more, (50 0.0 + 50.0 ⁇ 0.05), the upper limit value of the liquid feeding amount may be switched depending on whether it is included in the range.
  • the allowable range can be input to the control unit 100 by operating the operation button of the operation panel unit 4 in accordance with the display content of the display unit 3 in the same manner as the target value.
  • the input allowable range is stored in the nonvolatile memory 103.
  • FIG. 12 shows a display example of the display unit 3 when the allowable range is input together with the target value.
  • 50 is input as the target value of the bispectral index
  • ⁇ 5.00% is input as the allowable range.
  • the control unit 100 By configuring the control unit 100 as described above, the upper limit value of the liquid feeding amount can be switched when the value of the bispectral index is included in the allowable range based on the target value. Thereby, since the timing which switches the upper limit of liquid feeding amount can be set flexibly according to a condition, the convenience improves further.
  • the syringe pump according to the second embodiment is different from the operation of the control unit 100 of the syringe pump according to the first embodiment in the operation related to the switching of the upper limit value of the liquid feeding amount performed by the control unit and the adjustment of the liquid feeding amount. .
  • the control unit 100 of the syringe pump 1 according to the first embodiment adjusts the liquid feeding amount so that the blood concentration is maintained at the target concentration.
  • the control unit of the syringe pump according to the second embodiment is different from the control unit 100 in that the liquid supply amount is adjusted so that the effective site concentration is maintained at the target concentration.
  • FIG. 13 is a flowchart for explaining operations related to switching of the upper limit value of the liquid feeding amount and adjustment of the liquid feeding amount performed by the control unit of the syringe pump according to the second embodiment.
  • step S203 and step S207 in which liquid feeding is performed so as to maintain the effective site concentration at the target concentration.
  • the operation is the same as that of the control unit 100 of the pump 1.
  • step S201 for setting the upper limit introduction flow rate is the same as step S101.
  • Step S202 and Step S206 for determining whether or not the liquid feed end condition is satisfied are the same as Step S102 and Step S106.
  • Step S204 and Step S208 for determining whether or not the value of the bispectral index has reached the target value are the same as Step S104 and Step S108.
  • step S205 and step S209 for switching the upper limit value are the same as step S105 and step S109. Description of these steps will be omitted, and only the different steps S203 and S207 will be described below.
  • Step S203 and step S207 differ from the corresponding steps S103 and S107 of the control unit 100 in the first embodiment in the following points. That is, in step S103 and step S107, liquid feeding was performed so as to maintain the blood concentration at the target concentration. On the other hand, in step S203 and step S207, liquid feeding is performed so as to maintain the effective site concentration at the target concentration.
  • step S203 and step S207 the upper limit value stored in the nonvolatile memory 103 is not exceeded, and the effective site concentration of the drug after liquid feeding is the target concentration stored in the nonvolatile memory 103.
  • the liquid is fed at a liquid feed amount maintained at a constant value.
  • the effective site concentration of the drug after feeding can be calculated by simulation based on the amount of the medicine to be delivered, the patient information stored in the nonvolatile memory 103, the kind of medicine to be delivered, and the like. it can.
  • the liquid delivery of the medicine is performed by pressing the syringe pusher 202 as in step S103.
  • FIG. 14 is a graph showing an example of a change in the concentration of the drug in the living body when the drug is fed using the syringe pump according to the second embodiment.
  • d0 represents blood concentration
  • d1 represents effect site concentration
  • D1 represents target concentration.
  • b0 shows the value of a bispectral index
  • B1 shows the target value of a bispectral index.
  • T0 indicates a liquid feeding start time
  • T1 indicates a time when the blood concentration d0 reaches the target concentration D1
  • T2 indicates a time when the value of the bispectral index b0 reaches the target value B1.
  • the syringe pump according to the second embodiment starts feeding a drug at time T0 with the upper limit introduction flow rate as the upper limit value of the liquid feed amount.
  • the blood concentration d0 reaches the target concentration D1 at time T1.
  • the value of the bispectral index b0 reaches the target value B1 at time T2.
  • the upper limit value of the liquid feeding amount is switched from the upper limit introduction flow rate to the upper limit maintenance flow rate.
  • the effect site concentration d1 reaches the target concentration D1 in the vicinity of time T2.
  • the blood concentration d0 is not maintained at the target concentration between time T1 and time T2.
  • the liquid supply amount is adjusted so as to maintain the blood concentration at the target concentration.
  • the liquid supply amount is adjusted so as to maintain the effective site concentration d1 at the target concentration. It is.
  • the amount of liquid delivered between time T1 and time T2 is relatively greater in the second embodiment than in the first embodiment. Therefore, the time required for the value of the bispectral index to reach the target value can be relatively shortened as compared with the first embodiment.
  • the amount of liquid delivered when the drug is delivered is adjusted so as to maintain the effective site concentration at the target concentration.
  • the operation related to the adjustment of the liquid feeding amount performed by the control unit is different from the operation of the control unit 100 of the syringe pump 1 according to the first embodiment and its modification.
  • the control unit of the syringe pump according to the third embodiment performs the following operation in order to more optimally adjust the liquid feeding amount of the medicine. That is, the control unit of the syringe pump according to the third embodiment has a function as a vital determination unit that determines whether or not the value of the bispectral index has reached the target value. It has a function as a density determination unit that determines whether or not it has been reached.
  • the target concentration stored in the nonvolatile memory is changed. This is different from the control unit 100. Since the configuration of the main body cover 2, the display unit 3, and the operation panel unit 4 other than the control unit is the same as that of the first embodiment, the description thereof is omitted. Further, among the operations of the control unit of the syringe pump according to the third embodiment, operations such as driving of the motor driver 134 are the same as those in the first embodiment, and thus the description thereof is omitted.
  • the controller of the syringe pump according to the third embodiment will perform the following two operations in addition to the operation of the controller 100 of the syringe pump 1 according to the first embodiment and the modification thereof, if outlined.
  • the first operation is to set the target concentration stored in the nonvolatile memory to a predetermined amount when the effect site concentration has reached the target concentration even though the bispectral index value has not reached the target value. It is an operation to raise only. Thereby, as will be described later, it is possible to prevent the amount of the medicine to be fed more than necessary and promote the expression of the efficacy of the medicine.
  • the second operation is to set the target concentration stored in the nonvolatile memory to a predetermined amount when the effect site concentration does not reach the target concentration even though the value of the bispectral index has reached the target value. It is an operation to pull down only. Thereby, as will be described later, it is possible to prevent the medicine from being sent excessively.
  • FIG. 16 is a flowchart for explaining an operation related to adjustment of the liquid feeding amount performed by the control unit of the syringe pump according to the third embodiment.
  • the operation of the control unit of the syringe pump according to the third embodiment shown in FIG. 16 includes step S311 and step S313 for determining whether or not the effect site concentration has reached the target concentration, and step S310 for changing the target concentration. Except for step S312, the operation is the same as the operation of the control unit 100 of the syringe pump 1 according to the first embodiment. Specifically, step S301 for setting the upper limit introduction flow rate is the same as step S101. Further, Step S302 and Step S306 for determining whether or not the liquid feed end condition is satisfied are the same as Step S102 and Step S106.
  • Step S304 and Step S308 for determining whether or not the value of the bispectral index has reached the target value are the same as Step S104 and Step S108.
  • Steps S305 and S309 for switching the upper limit value are the same as steps S105 and S109. Description of these steps is omitted, and only the different steps S310 to S313 are described below.
  • step S311 for determining whether or not the effect site concentration has reached the target concentration the following processing is performed. First, based on the amount of the medicine delivered in step S303, the patient information stored in the nonvolatile memory 103, the kind of medicine to be delivered, and the like, the effect site concentration of the delivered medicine is simulated. Calculate. Next, it is determined whether or not the calculated effect site concentration has reached the target concentration stored in the nonvolatile memory 103. If it is determined that the target density has not been reached, the process returns to step S302. If it is determined that the target density has been reached, the process proceeds to step S310.
  • step S310 for changing the target density the following processing is performed. That is, processing for raising the target density stored in the nonvolatile memory 103 and changing it to a target density higher than the current density is performed.
  • the target density after change is calculated by adding the target density before change multiplied by the adjustment width to the target density before change. For example, when the target concentration before change is 3.00 mcg / ml and the adjustment range is 5.00%, (3.0 + 3.0 ⁇ 0.05) mcg / ml is set as the target concentration after change.
  • the method for calculating the target density after the change is not particularly limited as long as the target density after the change is higher than the target density before the change.
  • step S313 for determining whether or not the effect site concentration has reached the target concentration, the following processing is performed. First, based on the amount of the medicine delivered in step S307, the patient information stored in the nonvolatile memory 103, the kind of medicine to be delivered, and the like, the effect site concentration of the delivered medicine is simulated. Calculate. Next, it is determined whether or not the calculated effect site concentration has reached the target concentration stored in the nonvolatile memory 103. If it is determined that the target density has been reached, the process returns to step S306. If it is determined that the target density has not been reached, the process proceeds to step S312.
  • step S312 for changing the target density the following processing is performed. That is, a process is performed in which the target density stored in the nonvolatile memory 103 is lowered and changed to a target density lower than the current density.
  • the target density after change is calculated by subtracting the target density before change multiplied by the adjustment width from the target density before change. For example, when the target concentration before change is 3.00 mcg / ml and the adjustment range is 5.00%, (3.0-3.0 ⁇ 0.05) mcg / ml is set as the target concentration after change.
  • the method for calculating the target density after the change is not particularly limited as long as the target density after the change is lower than the target density before the change.
  • the adjustment width can be input to the control unit of the syringe pump according to the third embodiment by operating the operation button of the operation panel unit 4 according to the display content of the display unit 3.
  • the input adjustment width can be stored in the nonvolatile memory 103.
  • FIG. 15 shows a display content example of the display unit 3 when inputting the adjustment width.
  • FIG. 17 and FIG. 18 are graphs showing examples of changes in the bispectral index value and the concentration of the drug in the living body when the drug is fed using the syringe pump according to the third embodiment.
  • d0 indicates the blood concentration
  • d1 indicates the effect site concentration
  • D1 indicates the target concentration at the start of liquid feeding.
  • b0 shows the value of a bispectral index
  • B1 shows the target value of a bispectral index.
  • T0 shows a liquid feeding start time.
  • FIG. 17 shows an example in which steps S312 and S313 related to the reduction of the target density shown in FIG. 16 are executed.
  • FIG. 18 shows an example of the case where steps S310 and S311 related to the target density increase shown in FIG. 16 are executed.
  • the syringe pump according to the third embodiment starts feeding a drug at time T0 with the upper limit introduction flow rate as the upper limit value of the liquid feeding amount.
  • the blood concentration d0 reaches the target concentration D1 at time T1.
  • the value of the bispectral index b0 reaches the target value B1 at time T2.
  • the upper limit value of the liquid feeding amount is switched from the upper limit introduction flow rate to the upper limit maintenance flow rate.
  • the efficacy of the drug should be expressed at time T2. That is, if the target concentration D1 is correctly set as the concentration at which the efficacy of the drug is expressed, the effective site concentration d1 should reach the target concentration D1 at time T2. However, as shown in FIG. 17, there is a case where the effect site concentration d1 does not reach the target concentration D1 even though the value of the bispectral index b0 reaches the target value B1.
  • the target concentration D1 is set higher than the value that should be originally set as the concentration at which the efficacy of the drug is expressed. That would have been done.
  • the amount of medicine to be fed is adjusted so that the upper limit is not exceeded and the blood concentration d0 is maintained at the target concentration D1. Therefore, when the target concentration D1 is set to a high value, there is a possibility that the medicine is excessively fed, which is not preferable.
  • the control unit of the syringe pump according to the third embodiment lowers the target concentration D1 to the target concentration D1 ′ according to the flowchart shown in FIG. As a result, the amount of liquid to be delivered is adjusted so as not to exceed the upper limit value and the blood concentration d0 is maintained at the target concentration D1 ′. Since the target concentration D1 ′ is lower than the target concentration D1, it is possible to prevent the drug from being excessively fed in a state where the drug efficacy is expressed. Even after the target concentration D1 is lowered to the target concentration D1 ′ at time T2, the effective site concentration d1 continues to increase. Therefore, even after the target concentration D1 is lowered to the target concentration D1 ′, the state where the efficacy of the drug is expressed is maintained.
  • the syringe pump according to the third embodiment starts feeding a medicine at time T0 with the upper limit introduction flow rate as the upper limit value of the liquid feeding amount.
  • the blood concentration d0 reaches the target concentration D1 at time T1.
  • the effect site concentration d1 reaches the target concentration D1 at time T2.
  • the efficacy of the drug should be expressed at time T2. That is, if the target concentration D1 is correctly set as the concentration at which the efficacy of the drug is expressed, the value of the bispectral index b0 should reach the target value B1 at time T2. However, as shown in FIG. 18, there are cases where the value of the bispectral index b0 does not reach the target value B1 even though the effect site density d1 has reached the target density D1. In this case, since the effect of the drug is not expressed in spite of the effect site concentration d1 reaching the target concentration D1, the target concentration D1 is higher than the value that should be originally set as the concentration at which the effect of the drug is expressed. It was set low.
  • the amount of medicine to be fed is adjusted so that the upper limit is not exceeded and the blood concentration d0 is maintained at the target concentration D1. For this reason, when the target concentration D1 is set to be low, the amount of the medicine to be fed may be suppressed more than necessary, which is not preferable.
  • the control unit of the syringe pump according to the third embodiment raises the target concentration D1 to the target concentration D1 ′ according to the flowchart shown in FIG. As a result, the amount of liquid to be delivered is adjusted so as not to exceed the upper limit value and the blood concentration d0 is maintained at the target concentration D1 ′. Since the target concentration D1 ′ is higher than the target concentration D1, the amount of drug delivered increases in order to increase the blood concentration. Thereby, the expression of the efficacy of the drug is promoted.
  • the target concentration is adjusted according to whether or not the value of the bispectral index has reached a predetermined target value and whether or not the effect site concentration has reached the predetermined target concentration. Is done. Thereby, since the adjustment of the liquid feeding amount according to whether or not the efficacy of the drug is expressed is more optimal, the safety is further improved.
  • control part which concerns on this embodiment changed the target density
  • the target concentration may be changed when the liquid delivery amount is adjusted so that the effect site concentration is maintained at the target concentration.
  • the operation related to the adjustment of the liquid feeding amount performed by the control unit is different from the operation of the control unit 100 of the syringe pump according to the first embodiment and its modification.
  • the control unit of the syringe pump according to the fourth embodiment has a bispectral index value of a predetermined limit in order to more appropriately adjust the amount of liquid to be delivered. It differs from the control unit 100 in that the liquid feeding is stopped when the value is reached. Since the configuration of the main body cover 2, the display unit 3, and the operation panel unit 4 other than the control unit is the same as that of the first embodiment, the description thereof is omitted. Further, among the operations of the control unit of the syringe pump according to the fourth embodiment, operations such as driving of the motor driver 134 are the same as those in the first embodiment, and thus the description thereof is omitted.
  • the control unit accepts input of the limit value of the bispectral index in addition to the input of the target value of the bispectral index described in the first embodiment.
  • the limit value of the bispectral index can be input to the control unit according to the fourth embodiment by operating the operation button of the operation panel unit 4 according to the display content of the display unit 3.
  • FIG. 19 shows an example of display contents of the display unit 3 when inputting the limit value of the bispectral index.
  • the limit value of the bispectral index can be input by operating the operation button of the operation panel unit 4 in accordance with the display content example shown in FIG.
  • FIG. 20 is a flowchart for explaining the operation related to the adjustment of the liquid feeding amount performed by the control unit of the syringe pump according to the fourth embodiment.
  • step S410 in which it is determined whether or not the bispectral index value has reached the limit value.
  • the operation is the same as that of the first control unit 100.
  • step S401 for setting the upper limit introduction flow rate is the same as step S101.
  • Step S402 and Step S406 for determining whether or not the liquid feed end condition is satisfied are the same as Step S102 and Step S106.
  • Steps S404 and S408 for determining whether or not the bispectral index value has reached the target value are the same as steps S104 and S108.
  • step S405 and step S409 for switching the upper limit value are the same as step S105 and step S109. Description of these steps will be omitted, and only the different step S410 will be described below.
  • Step S410 for determining whether or not the value of the bispectral index has reached the limit value is aimed at the following. That is, when the value of the bispectral index has reached the limit value of the bispectral index stored in the nonvolatile memory 103, the purpose is to prevent the medicine from being fed.
  • step S410 the following processing is performed. That is, the value of the bispectral index is compared with the limit value of the bispectral index stored in the nonvolatile memory 103. When the bispectral index value has reached the limit value of the bispectral index stored in the nonvolatile memory 103, the process returns to step S406. If the bispectral index value has not reached the limit value of the bispectral index stored in the nonvolatile memory 103, the process proceeds to step S407.
  • FIG. 21 is a graph showing an example of changes in the concentration of the drug in the living body when the drug is fed using the syringe pump according to the fourth embodiment.
  • d0 represents the blood concentration
  • d1 represents the effect site concentration
  • D1 represents the target concentration at the start of liquid delivery.
  • b0 shows the value of a bispectral index
  • B1 shows the target value of a bispectral index.
  • T0 shows a liquid feeding start time.
  • the syringe pump according to the fourth embodiment starts feeding a medicine at time T0 with the upper limit introduction flow rate as the upper limit value of the liquid feeding amount.
  • the blood concentration d0 reaches the target concentration D1 at time T1.
  • the value of the bispectral index b0 reaches the target value B1 at time T2.
  • the upper limit value of the liquid feeding amount is switched from the upper limit introduction flow rate to the upper limit maintenance flow rate.
  • the efficacy of the drug should be expressed at time T2. That is, if the target concentration D1 is correctly set as the concentration at which the efficacy of the drug is expressed, the effective site concentration d1 should reach the target concentration D1 at time T2. However, as shown in FIG. 21, although the value of the bispectral index b0 has reached the target value B1, the effective site concentration d1 may not reach the target concentration D1. In this case, the effect site concentration d1 continues to increase after time T2 even though the efficacy of the drug is expressed at time T2. As a result, the efficacy of the drug may be expressed more than necessary, which is not preferable.
  • the control unit of the syringe pump according to the fourth embodiment stops the liquid feeding when the value of the bispectral index b0 reaches the limit value BL according to the flowchart shown in FIG. In the example shown in FIG. 21, the liquid feeding of the medicine is stopped at time T3. As a result, after the time T3, the increase in the effective site concentration d1 becomes slow, and it can be prevented that the efficacy of the drug is unnecessarily expressed.
  • the value of the bispectral index b0 starts to increase.
  • the value of the bispectral index b0 returns to the limit value BL at time T4. Therefore, since the liquid delivery of the medicine is resumed at time T4, the expression of the efficacy of the medicine is not weakened more than necessary.
  • the liquid feeding is stopped when the value of the bispectral index reaches a predetermined limit value.
  • control unit adjusts the liquid supply amount so that the blood concentration is maintained at the target concentration, and the liquid supply is performed when the value of the bispectral index reaches a limit value. Although it stopped, it is not limited to this. For example, in the case where the liquid supply amount is adjusted so that the effect site concentration is maintained at the target concentration, the liquid supply may be stopped when the value of the bispectral index reaches a limit value.
  • the medicine can be delivered while adjusting the liquid delivery amount more appropriately according to the technique to be applied, the kind of the medicine, or the like.
  • the operation related to the adjustment of the liquid feeding amount performed by the control unit is different from the operation of the control unit 100 of the syringe pump according to the first embodiment and the modification thereof in the following points. That is, in the control unit 100 of the syringe pump according to the first embodiment and the modification thereof, the target concentration to be maintained at the target concentration is predetermined.
  • the control part of the syringe pump according to the fifth embodiment relates to the first embodiment and its modification, in that the concentration of the target to be maintained at the target concentration can be specified in order to improve safety and convenience. Different from the control unit 100 of the syringe pump.
  • the control unit of the syringe pump according to the fifth embodiment adjusts the liquid feeding amount so that the concentration designated as the target to be maintained at the target concentration is maintained at the target concentration.
  • the control unit of the syringe pump according to the fifth embodiment sends the simulated effective site concentration so as to be maintained at the target concentration. Adjust the liquid volume.
  • the control unit of the syringe pump according to the fifth embodiment controls the amount of liquid delivered so that the simulated blood concentration is maintained at the target concentration. adjust.
  • the target concentration to be maintained at the target concentration can be designated to the control unit according to the fifth embodiment by various methods.
  • the target density to be maintained at the target density can be designated to the control unit according to the fifth embodiment. it can.
  • safety and convenience are further improved because it is easy to appropriately set the target concentration to be maintained at the target concentration according to the technique to be applied and the type of medicine.
  • the determination as to whether or not the efficacy of the delivered drug is manifested is made using the bispectral index value.
  • another observation may be used. For example, if a certain relationship is observed between the observed values such as blood pressure, body temperature, pulse, eye movement, etc. and the state of manifestation of the efficacy of the drug being delivered, the efficacy of the drug can be determined using the observed values. It may be determined whether or not it is expressed.
  • the configurations described in the first to fifth embodiments and the modifications thereof can be combined as appropriate.
  • the configuration of the control unit according to the target concentration change described as the third embodiment and the configuration of the control unit according to the stop of liquid feeding described as the fourth embodiment You may comprise the syringe pump which concerns on this invention.
  • the present invention is not limited thereto.
  • the present invention can be widely applied to medical liquid feeding pumps such as an infusion pump capable of adjusting the liquid feeding amount of a medicine.

Landscapes

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

Abstract

La présente invention vise à fournir une pompe d'administration de fluide qui, lors de l'administration d'un médicament, permet d'administrer le médicament dans une quantité appropriée d'administration de fluide, qui ne dépasse pas une valeur de limite supérieure prescrite stipulée pour chaque type de médicament. À cet effet, l'invention concerne une pompe d'administration de fluide pour administrer un médicament tout en simulant la concentration du médicament administré à l'intérieur d'un organisme, la pompe d'administration de fluide stockant le flux d'admission de limite supérieure d'un médicament et le flux de maintien de limite supérieure du médicament et, selon si la valeur observée dans les signes vitaux de l'organisme auquel est administré le médicament atteint une valeur cible ou non, commute la valeur de limite supérieure pour la quantité d'administration de fluide du médicament au flux d'admission de limite supérieure ou au flux de maintien de limite supérieure.
PCT/JP2015/057382 2014-03-20 2015-03-12 Pompe d'administration de fluide WO2015141562A1 (fr)

Applications Claiming Priority (2)

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JP2014-058589 2014-03-20
JP2014058589A JP2017086098A (ja) 2014-03-20 2014-03-20 送液ポンプ

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WO2015141562A1 true WO2015141562A1 (fr) 2015-09-24

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KR102182592B1 (ko) * 2020-03-10 2020-11-24 이건형 실린더 펌프
KR102542266B1 (ko) * 2021-03-15 2023-06-14 충북대학교 산학협력단 진정 환자의 혈액농도 자가 조절용 버튼을 포함한 진정제 tci-pcs 펌프 장치 및 그 작동 방법

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US20010022182A1 (en) * 2000-03-17 2001-09-20 Rolf Heitmeier Anaesthetic controller
JP2003531691A (ja) * 2000-05-03 2003-10-28 アスペクト メディカル システムズ，インク． 即応性薬物運搬システムと方法
US20060009729A1 (en) * 2004-07-07 2006-01-12 Drager Medical Ag & Co. Kgaa Apparatus for controlling the delivery of medical fluids
US20110137134A1 (en) * 2007-01-17 2011-06-09 Thomas Hemmerling Method and system for administering an anaesthetic
US20100241064A1 (en) * 2007-10-15 2010-09-23 The Secretary, Department Of Information Technology Automatic Anaesthesia Delivery System
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CN113144336B (zh) * 2021-05-26 2023-11-10 深圳中科生物医疗电子有限公司 一种输注泵

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