WO2020166102A1

WO2020166102A1 - Liquid medicine administration device and liquid medicine administration method

Info

Publication number: WO2020166102A1
Application number: PCT/JP2019/025685
Authority: WO
Inventors: 勝平佐々木
Original assignee: テルモ株式会社
Priority date: 2019-02-15
Filing date: 2019-06-27
Publication date: 2020-08-20
Also published as: JP7299929B2; JPWO2020166102A1

Abstract

To be able to change the residual amount of a liquid medicine at which an alert is generated according to a patient's profile from the total dosage per day of a set basal rate pattern, the total dosage of the liquid medicine is calculated and a residual amount value at which a residual amount alert is generated according to the patient's condition is calculated on the basis of the basal rate delivery pattern of the patient to whom the liquid medicine is administered. When the calculated residual amount value is equal to or above a predetermined value that is set in advance for pressing a residual amount switch, the residual amount alert is generated when a residual amount switch is pressed, and when the calculated residual amount value is less than the set predetermined value, the residual amount alert is generated when the residual amount of the liquid medicine is counted and the count value reaches the residual value.

Description

Chemical liquid administration device and chemical liquid administration method

The present invention relates to a drug administration device and a drug administration method, and more particularly to a drug administration device and a drug administration method capable of changing the drug administration method depending on the profile of a patient.

In recent years, treatment methods that continuously administer the drug solution into the patient's body by subcutaneous injection or intravenous injection have been performed. For example, as a treatment method for diabetic patients, a treatment of continuously injecting a small amount of insulin into the body of the patient has been carried out. In this treatment method, a portable liquid medicine administration device (so-called insulin pump) fixed to the patient's body or clothes is used to administer the medicine liquid (insulin) to the patient all day long.

In such a drug solution administration device, it is extremely important to notify the user of how much drug solution remains in the cylinder that stores the drug solution.
However, in the conventional drug solution administration device, if the remaining amount of the drug solution in the cylinder is a predetermined amount, for example, the full amount for 3 days is 200 U (unit), it becomes 1/4 that of 50 U (unit). At times, I only notified the remaining amount alert.

Patent Document 1 discloses a portable drug solution administration device that continuously or intermittently administers a drug solution filled in a cylinder into a living body under the pressing action of a plunger. Depending on the position, the contact sensor that notifies the user that the remaining amount of the drug solution in the cylinder has reached a predetermined amount is shown.
International publication 2016/132937

However, there are individual differences in the amount of drug solution that is administered to the body, and for example, the amount of drug solution that is administered daily for adults and children (particularly children) is usually very different. In addition, the amount of drug solution to be administered also changes depending on the patient's condition such as weekdays, exercising or illness, and meal content. Therefore, it was not appropriate to determine the predetermined amount (for example, 50 U) of the residual amount of the liquid medicine in the cylinder at the time of notifying the patient of the alert. For example, a child may use about 50 U of insulin filled in 3 days, and in this case, the alert of the remaining amount of 50 U is too early.

The present invention has been made in order to solve the above-described problems, and does not fix the remaining amount of the drug solution that generates an alert to a predetermined amount (for example, 50 U) from the total dose of the drug solution, and the patient situation ( It is an object of the present invention to provide a liquid medicine administration device and a liquid medicine administration method that can be changed according to the profile).

In order to solve the above problems and achieve the object of the present invention, the present invention is a drug solution administration device which issues a residual amount alert when the residual amount of the drug solution in the cylinder reaches a predetermined value, and the total administration of the drug solution. In addition to calculating the amount, the remaining amount value that issues a remaining amount alert from the total dose of the drug solution and outputs the remaining amount alert signal, and the remaining amount alert signal based on the remaining amount alert signal output from the calculating unit And a notification unit that emits.
Then, when the calculated remaining amount value is equal to or larger than the predetermined value, the calculation unit outputs a remaining amount alert signal to the notification unit when the remaining amount of the chemical liquid reaches the predetermined value, and the calculated remaining amount value is the predetermined value. When it is less than, the remaining amount of the chemical liquid is counted, and when the count value reaches the calculated remaining amount value, the remaining amount alert signal is output to the notification unit.

Further, the drug solution administration method of the present invention is a drug solution administration method that issues a residual amount alert when the residual amount of the drug solution in the cylinder reaches a predetermined value, and includes the following steps.
(A) A step of calculating the remaining amount value of the liquid medicine which issues a remaining amount alert from the total dose of the liquid medicine by a calculation unit,
(B) When the remaining amount value for issuing the remaining amount alert is equal to or greater than a predetermined value, a step of outputting a remaining amount alert signal by the calculation unit when the remaining amount of the chemical liquid reaches the predetermined value,
(C) When the remaining amount value for issuing the remaining amount alert is less than a predetermined value, a step of starting the counting of the remaining amount of the medical liquid by the calculation unit when the remaining amount of the medical liquid reaches the predetermined value,
(D) A step of outputting a remaining amount alert signal by a computing unit when the count value reaches a remaining amount value for issuing a remaining amount alert.

According to the present invention, it is possible to notify the alert of the remaining amount of the liquid medicine in the cylinder under the optimal condition of the patient in consideration of the condition of the adult, the child, or the patient.

It is a block diagram which shows an example of the chemical|medical solution administration support system in which the chemical|medical solution administration apparatus which concerns on the example of one Embodiment of this invention is used. FIG. 1 is an exploded perspective view of a drug solution administration device according to an embodiment of the present invention. It is a sectional view of a medical fluid administration device concerning one example of an embodiment of the present invention. 6 is a display screen showing a decrease in the amount of remaining liquid medicine in the liquid medicine administration device according to the embodiment of the present invention. FIG. 7 is a display screen A when changing a preset administration pattern and a display screen B when confirming and determining a basal rate pattern in the drug solution administration device according to the embodiment of the present invention. FIG. It is a block diagram for explaining the function of the medical fluid administration device concerning the example of one embodiment of the present invention. It is a flow chart for explaining the procedure of the medical fluid administration method concerning one embodiment example of the present invention.

<Description of the overall configuration of the drug solution administration support system>
First, before explaining an embodiment of the present invention, an outline of a drug administration support system in which a drug administration device according to an embodiment of the present invention is used will be described with reference to FIG.
As shown in FIG. 1, the drug solution administration support system 1 includes a drug solution administration device (pump body) 100 and a remote controller 200 used in combination with the drug solution administration device 100.

The drug solution administration device 100 is a drug solution pump that is used by being worn on the skin of a patient in order to administer a drug solution such as insulin to the patient over a long period of time. Such a drug solution administration device 100 includes a communication unit with the remote controller 200 as described later.

On the other hand, the remote controller 200, which operates the drug solution administration device 100, is a mobile terminal such as a smartphone that is carried by the patient and is not worn on the skin of the patient.
The remote controller 200 has an integrated operation unit 200 a and display unit 200 b, and also includes a control unit (not shown) and a communication unit with the drug solution administration device 100. The operation unit 200a may be, for example, a display screen of the display unit 200b provided with a touch panel, or may be an operation button provided at a position apart from the display unit 200b.

The drug solution administration support system 1 creates a dosing profile in basal insulin administration (basal administration) and doses (bolus amounts) at the time of additional administration (bolus administration) in the drug administration performed by the drug administration device 100. Set the parameters for calculation.

The drug solution administration support system 1 is usually composed of a remote controller 200, but a terminal device 300 such as a personal computer or a tablet terminal, which is different from the remote controller 200 and can communicate with the remote controller 200 or the drug solution administration device 100. You may comprise by. In this case, as shown in FIG. 1, the operation unit 300a and the display unit 300b are not integrated.

<Explanation of the configuration of the drug solution administration device>
Next, the configuration and operation of the chemical liquid administration device 100 used in the embodiment of the present invention will be described with reference to FIGS. 2 to 4. The drug solution administration device 100 used in the present invention includes an insulin pump that continuously or intermittently administers the drug solution filled in the cylindrical body 18 into the living body by the pressing action of the plunger 20.

As shown in FIG. 2, the drug solution administration device 100 includes a disposable disposable unit 12, a reusable reuse unit 14, and a drive unit 40 (see FIG. 3) mainly provided in the reuse unit 14. The disposable part 12 includes a flat box-shaped base part 16 which is open on one side. The base portion 16 is formed so as to be detachable from a cradle (not shown). The cradle includes a cannula placed in the living body and can be attached to the skin of the user (patient).

As shown in FIGS. 2 and 3, the base portion 16 includes a cylindrical body 18 filled with a chemical solution, a plunger 20 provided in the cylindrical body 18, and a feed screw shaft 22 arranged coaxially with the plunger 20. And a nut portion (movable portion) 24 screwed to the feed screw shaft 22.

The tubular body 18 extends in a cylindrical shape along the longitudinal direction of the base portion 16. The outer diameter and the inner diameter of the tip of the tubular body 18 are reduced toward the tip. An introduction port 26 (see FIG. 2) for introducing the chemical liquid into the cylinder body 18 and a discharge port 28 for discharging the chemical liquid in the cylinder body 18 are provided at the tip of the cylinder body 18. A lead-out pipe 29 for guiding the drug solution in the tubular body 18 to a cannula (not shown) communicates with the lead-out port 28.

The plunger 20 is configured to be slidable in the tubular body 18 along the axial direction of the tubular body 18. That is, the plunger 20 has the plunger main body 30 that constitutes the front end side and the pusher 32 that pushes the rear end side of the plunger main body 30. A pair of packings 34 is attached to the rear end side of the plunger body 30 which is formed in a cylindrical shape.

The pusher 32 includes a pair of extending portions 36 extending rearward from the plunger body 30 to the outside of the cylindrical body 18, and a pair of claw portions 38 provided at the rear end of the extending portion 36. One end of the feed screw shaft 22 is rotatably supported by a bearing 39 and moves the nut portion 24.

The drive unit 40 is rotatable integrally with the battery 42 as a power source, a motor 44 driven by the battery 42, a gear box 46 for decelerating and transmitting the rotational driving force of the motor 44, and the feed screw shaft 22. It has a transmission shaft 52 that is locked. A spur gear 50 that meshes with the output gear 48 of the gear box 46 is fixed to the transmission shaft 52.

In this embodiment, the battery 42 and the transmission shaft 52 shown by the solid line are provided in the disposable section 12, and the motor 44 and the gear box 46 shown by the two-dot chain line are provided in the reuse section 14 (see FIG. 2). The battery 42 is provided with a terminal 54 that electrically connects the battery 42 to the motor 44 when the reuse unit 14 is attached to the disposable unit 12. The transmission shaft 52 is rotatably supported by a pair of bearings 56 provided on the base portion 16 while being coaxially arranged with the feed screw shaft 22. The motor 44 is configured to drive the feed screw shaft 22 to rotate only in the direction in which the nut portion 24 moves to the tip end side of the plunger 20.

The nut part 24 has a nut part body 58 formed in a substantially rectangular parallelepiped shape, and a slide part 60 provided on the nut part body 58. The nut body 58 is provided with a screw hole 62 into which the feed screw shaft 22 is screwed, and a pair of through holes 64 formed so as to sandwich the screw hole 62 from both sides and through which the claw portion 38 is inserted. A reinforcement cover 66 made of, for example, a metal material is attached to the outer surface of the nut portion main body 58.

The slide part 60 slides along a guide wall 68 extending along the axial direction of the plunger 20. As shown in FIG. 3, in the state before use, the nut portion 24 is in the initial position where it does not come into contact with the plunger 20, and is moved from the initial position by the rotation action of the feed screw shaft 22, and comes into contact with the plunger 20 to move the plunger 20. Press on the tip side.

As shown in FIG. 2, the reuse unit 14 includes a lid body 70 that closes the opening of the base portion 16, and a control unit 72 provided on the lid body 70. The control unit 72 includes a sensor (initial position detection sensor) 74 that detects the initial position of the nut unit 24, a sensor (predetermined position detection sensor) 76 that detects that the nut unit 24 has reached a predetermined position, and an alert unit. 78 and the drive unit 40 shown in FIG. The predetermined position detection sensor 76 detects the remaining amount of the chemical liquid in the cylindrical body 18. Then, the predetermined position detection sensor 76 functions as a remaining amount switch that operates the alert unit 78 when the amount of the chemical liquid in the cylindrical body 18 becomes a predetermined amount or less (for example, 50 U or less). That is, the predetermined position detection sensor 76 is a contact sensor that comes into contact with the nut portion 24 when the nut portion 24 moves to a predetermined position where the chemical liquid in the tubular body 18 reaches a predetermined amount.

The initial position detection sensor 74 detects whether or not the nut portion 24 is in the initial position before moving the nut portion 24. Specifically, the initial position detection sensor 74 is a contact sensor with which the nut part 24 at the initial position comes into contact when the reuse part 14 is attached to the disposable part 12. The initial position detection sensor 74 can easily detect whether or not the nut portion 24 is at the initial position. The contact sensor is merely an example, and the initial position detection sensor 74 and the predetermined position detection sensor 76 can be configured as non-contact sensors.

As described above, by configuring the predetermined position detection sensor 76 as a contact or non-contact sensor, it is possible to easily detect whether or not the nut portion 24 has reached a predetermined position (a position for issuing a chemical solution remaining amount alert). .. Further, although the initial position detection sensor 74 and the predetermined position detection sensor 76 are provided in the reuse unit 14, both or one of the initial position detection sensor 74 and the predetermined position detection sensor 76 is provided on the disposable unit 12 side. Good.

The alert unit 78 as a notification unit may output only one type of alert sound, but it may also output multiple types of alert sounds. In that case, at least one of the frequency, the amplitude, the output time, and the output frequency of the sound may be made different. It should be noted that the alert unit 78 is not always necessary, and the remaining amount of the liquid medicine is low on the

display units

200b and 300b of the remote controller 200 or the terminal device 300 shown in FIG. You may also display that it has become.

<Explanation of operation/action of drug administration device>
The drug solution administration device 100 used in the present invention is configured as described above, and its operation and action will be described below.
In the state where the user (patient) takes out the disposable part 12 from the packaging container, the drug solution is not filled in the cylindrical body 18 of the disposable part 12. At this time, the nut portion 24 is in the initial position where it does not contact the plunger 20.

Next, the user (patient) adjusts the position of the plunger 20 with respect to the cylinder 18 and fills the cylinder 18 with an appropriate amount of the drug solution from the drug solution container in which the drug solution is hermetically stored. Then, the reuse section 14 is attached to the disposable section 12. As a result, the output gear 48 of the gear box 46 of the reuse section 14 meshes with the spur gear 50 of the disposal section 12, and the battery 42 of the disposal section 12 supplies electric power to the components of the reuse section 14.
The control unit 72 is activated by the electric power of the battery 42, and the initial position detection sensor 74 detects that the nut unit 24 is at the initial position. It is assumed that the disposable part 12 is not used but is unused.

Next, the user performs priming of the drug solution administration device 100. Specifically, the remote controller 200 shown in FIG. 1 is operated to rotationally drive the motor 44 of the drug solution administration device 100. Then, the rotational driving force of the motor 44 is transmitted to the feed screw shaft 22 via the gear box 46, the spur gear 50, and the transmission shaft 52. Then, the feed screw shaft 22 rotates, and the nut portion 24 advances toward the plunger 20 side while sliding on the guide wall 68.

When the nut portion 24 advances toward the tip end side of the plunger 20, the pair of claw portions 38 are inserted into the through holes 64 of the nut portion 24, and the pair of extending portions 36 bend so as to be close to each other. When the pawl portion 38 passes through the through hole 64, the pawl portion 38 returns to its original position and the nut portion 24 is locked to the plunger 20. As a result, the nut portion 24 can press the tip side of the plunger 20. Then, by further advancing the nut portion 24, the chemical liquid in the cylindrical body 18 is pressed by the plunger 20 and the inner hole of the outlet pipe 29 is filled with the chemical liquid, and the priming is completed.

After that, the user attaches a cradle (not shown) to a predetermined position on the skin, and uses the puncture mechanism to leave the cannula locked in the cradle in the living body. When the drug solution administration device 100 is connected to the cradle, the lead-out tube 29 and the cannula communicate with each other, and the motor control unit (not shown) in the control unit 72 controls the rotation of the motor 44 so that the drug solution in the tubular body 18 is maintained in the living body. Administered intermittently or intermittently.

Then, the predetermined position detection sensor 76 detects that the nut portion 24 moved from the initial position has arrived at a predetermined position (a position for issuing an alert of the remaining amount of the chemical liquid in the tubular body 18). That is, when the nut portion 24 reaches the predetermined position, the predetermined position detection sensor 76 is turned on and the alert sound is output from the alert portion 78.
Alternatively, the remaining amount alert is displayed on the display screen of the display unit 200b of the remote controller 200. Here, as shown in FIG. 4, a display such as "The remaining amount of the remaining amount of the reservoir is 50U" is displayed. As a result, the user can know that the remaining amount of the chemical liquid in the cylindrical body 18 has reached a predetermined amount (for example, 50 U). Then, in the case of intermittently administering the liquid medicine in an amount larger than the predetermined amount, it is possible to take measures such as exchanging the disposable part 12 with an unused product.

<Operation of the drug solution administration device as the embodiment of the present invention>
The point described above is the technology already disclosed in Patent Document 1, but the drug solution administration device 100 according to the embodiment of the present invention further sets the remaining amount of the drug solution in the tubular body 18 for alerting the user. The feature is that the software can be changed according to the weight (difference between adult and child) and condition. Hereinafter, with reference to FIG. 5 to FIG. 7, the operation of the drug solution administration device 100 according to the embodiment of the present invention will be described.

First, in the embodiment of the present invention, the remaining amount switch (a predetermined position in FIG. 2) of a value (for example, 50 U) that usually alerts the remaining amount of the liquid medicine from the total daily dose of the set basal rate pattern is set. It is determined whether or not the detection sensor 76) is used. When it is determined that the 50U remaining amount switch is not used, that is, when the value for issuing the remaining amount alert is 50U or less, the remaining amount X of the chemical liquid of 50U or less is set by software, and the remaining amount of the chemical liquid is set. The remaining amount alert is notified when the amount reaches X. The point that the remaining amount of the remaining amount alert is set to 50 U is merely an example, and the remaining amount value of this alert is set to a predetermined value (hereinafter, “predetermined value”) according to the profile of the patient. It

FIG. 5A shows, as an example, three patterns 1 to 3 in setting the basal rate administration stored in the controller 200. Pattern 1 is a pattern for selecting a normal weekday basal rate administration. Pattern 2 is a basal rate administration pattern when the patient is exercising, and in this case, the dose is smaller than in normal times. Pattern 3 is a basal rate administration pattern when the user is ill, and in this case, the dose varies depending on the individual user.

In any of the basal rate administration patterns, the total daily dose differs between adults and children, or fat and thin people. Therefore, the user's profile is selected from preset basal rate administration patterns 1 to 3. The basal rate dosing pattern is selected according to. The basal rate administration pattern is not limited to the three patterns shown in FIG. 5A. In addition, the setting can be changed depending on the weight difference of the user who is the user. The basal rate administration pattern is changed by touching any of the display screens (FIG. 5A) of the remote controller 200.

For an adult of average weight, normally, the full amount of the drug solution for three days filled in the cylindrical body 18 is about 200 U, and when the remaining amount becomes 50 U which is a quarter, It is set to issue a remaining amount alert. This value is a value that changes depending on the weight of an adult. In the case of children, the total amount of drug solution to be administered in 3 days is usually set to about 60 U, though it depends on the weight.

In other words, for children, if the total daily dose at the basal rate is 10.20 U, the frequency of replacement of the disposable part 12 is once every three days, and the margin including the bolus amount is doubled, the total daily dose will be three days. The dose is as follows.
10.20 [U] x 3 [days] x 2 [times] = 61.2 [U]
When it is set to issue the remaining amount alert with a quarter of the total dose of 61.2 U for these three days,
61.2 [U]/4=15.3 [U]
Then, when the remaining amount of the chemical solution reaches 15.3 U, a remaining amount alert may be issued. That is, it is necessary to set a value smaller than the usual adult setting value of 50 U as the remaining amount alert value.

<Functional explanation of the drug solution administration device according to the embodiment of the present invention>
FIG. 6 is a block diagram showing the functions of the drug solution administration device (pump body) 100 and the remote controller 200 according to the embodiment of the present invention.
The drug solution administration device 100 includes a power supply unit 101, a drive unit 102, a remaining amount detection unit 103, an output unit 104, a date/time management unit 105, a data storage unit 106, a main body communication unit 107, and a main body calculation unit 108 that controls these. ..

The power supply unit 101 is for supplying electric power to each constituent element of the chemical liquid administration device 100, and includes, for example, the battery 42 shown in FIGS. 2 and 3, a battery box (not shown) that houses the battery 42, and a battery. It is composed of a switch (not shown) for turning on/off the power supply from 42.

The drive unit 102 is for performing drug solution administration to a patient wearing the drug solution administration device 100, and corresponds to the drive unit 40 in FIG. 3. That is, as described with reference to FIGS. 2 and 3, the drive unit 102 includes the cylinder 18 for containing the liquid medicine to be administered, the pusher 32 slid in the cylinder 18, and the motor for moving the pusher 32. 44 and a gear box 46 and the like.

The remaining amount detection unit 103 includes a remaining amount switch (predetermined position detection sensor 76 in FIGS. 2 and 3) and a counter unit (not shown). The counter unit counts the number of rotations of the motor 44. The remaining amount detection unit 103 outputs a detection signal to the main body calculation unit 108 when the predetermined position detection sensor 76 detects the remaining amount of a predetermined amount (for example, 50 U) of the chemical liquid to be alerted. Then, the main body calculation unit 108 activates the alert unit 78 to generate an alarm sound. Alternatively, a signal for sending an alert is sent to the remote controller 200 via the main body communication unit 107, and, for example, on the display screen of the display unit 200b of the remote controller 200, for example, as shown in FIG. Is displayed."

Further, the remaining amount detection unit 103 outputs the rotation speed of the motor 44 counted by the counter unit to the main body calculation unit 108. The main body calculation unit 108 counts the remaining amount of the chemical liquid based on the rotation speed of the motor 44 output from the remaining amount detection unit 103.

However, this alert is issued only when the amount of drug solution, which is a quarter of the total dose for 3 days, is 50 U or more. When the amount of the drug solution that is a quarter of the total dose for 3 days is less than 50 U, even if the position of the predetermined position detection sensor 76 is detected, an alert is not issued and a counter unit (not shown) The remaining amount of the chemical liquid in the cylindrical body 18 is counted. The remaining amount of the chemical liquid is counted by counting the number of rotations of the motor 44 with an encoder (not shown).

Then, when the remaining amount of the liquid medicine in the cylindrical body 18 matches the remaining amount alert value X for issuing an alert, the main body calculation unit 108 of the liquid medicine administration device 100 transfers the remote controller 200 to the remote controller 200 via the main body communication unit 107. Send a signal to display an alert. In response to the alert signal from the liquid medicine administration device 100, the controller operation unit 208 of the remote controller 200 alerts the display screen of the display unit 204, for example, "remaining low amount of the reservoir X is X". Display.

The output unit 104 as a notification unit is, for example, the alert unit 78 shown in FIG. 2, and normally, when communication between the chemical solution administration device 100 and the remote controller 200 is interrupted, an alarm is issued by an instruction from the main body calculation unit 108. Output. As the alarm, vibration or sound may be used alone or in combination, or may emit light.

The date and time management unit 105 is a program function for performing date and time management, and is a function installed in a general microcomputer to output date and time information. Since the date and time management unit 105 is supplied with power even when the power is off, it is possible to output accurate date and time information.

The data storage unit 106 stores various data for controlling the drug solution administration device 100. In the data, the remote controller 200 issues an alert calculated based on the basal rate administration pattern of the patient. The alert value X of the remaining amount of the chemical liquid is included. In addition, for example, controller forget prevention function data, automatic bolus administration data, administration history data, basic rate administration data (basal administration data), data for pairing, and the like. Note that these data have no direct relationship with the present embodiment and are described in detail in Japanese Unexamined Patent Application Publication No. 2017-148393, which is a prior patent document, and therefore description thereof will be omitted.

The main body communication unit 107 performs wireless communication between the drug solution administration device 100 and the remote controller 200. The main body communication unit 107 has a transmission unit and a reception unit, and performs radio communication using radio waves in a predetermined wavelength band, for example, ultrashort waves or microwaves. The main body communication unit 107 transmits/receives a signal to/from the controller communication unit 207 in the paired remote controller 200 according to an instruction from the main body calculation unit 108 to establish communication with the controller communication unit 207. To do.

The main body calculation unit 108 stores various data received by the main body communication unit 107 in the data storage unit 106. Further, the main body arithmetic unit 108 drives the drive unit 102 based on the signal transmitted from the remote controller 200, and outputs an alarm from the output unit 104. Furthermore, the main body calculation unit 108 drives the drive unit 102 based on various data stored in the data storage unit 106, and performs basal insulin administration and bolus of insulin to the user (patient) who wears the drug solution administration device 100. Control dosing.

<Explanation of Functions of Remote Controller 200>
As shown in FIG. 6, the remote controller 200 includes a power supply unit 201, an input unit 202, an output unit 203, a display unit 204, a date/time management unit 205, a data storage unit 206, a controller communication unit 207, and a controller operation for controlling them. The unit 208 is provided.

Among the above-mentioned constituent elements, those having the same function as the constituent elements of the drug solution administration device 100 will be omitted, and only the constituent elements having a different function from the drug solution administration device 100 will be described.

In the present embodiment example, in addition to displaying an alert when the remaining amount of the liquid medicine is below a predetermined value, the display unit 204 displays various setting contents, contents input by the input unit 202, or the liquid medicine administration device 100. The administration history, etc. are displayed. The display unit 204 is composed of, for example, a liquid crystal display. 4 and 5 are examples of display screens displayed on the display unit 204. In addition to this screen, the display unit 204 also displays various data used for the operation of the drug solution administration device 100. It

The input unit 202 inputs data such as an on/off operation of a power source, settings of insulin administration by the drug solution administration device 100, and display contents on the display unit 204. The input unit 202 includes, for example, a keypad and a touch panel provided on the front surface of the display unit 204.
The functions of the output unit 203, the date/time management unit 205, the data storage unit 206, and the controller communication unit 207 are the same as those of the output unit 104, the date/time management unit 105, the data storage unit 106, and the main body communication unit 107 of the drug administration device 100. Then, the description is omitted.

The controller calculation unit 208 stores the various settings input in the input unit 202 and the remaining amount alert value X of the chemical liquid that issues an alert in the data storage unit 206. Then, the data necessary for the drug solution administration device 100 side, including the alert value X of the remaining amount of the drug solution that issues an alert, is transmitted to the main body communication unit 107 of the drug solution administration device 100 via the controller communication unit 207.

<Explanation of operation relating to procedure of drug solution administration method according to embodiment of the present invention>
FIG. 7 is a flowchart for explaining the procedure of the drug solution administration method according to the embodiment of the present invention.
As shown in FIG. 7, before starting administration of the drug solution, first, a basal rate administration pattern of the drug solution is selected (step S1). In step S1, the optimal basal rate administration pattern is selected according to the patient's condition (profile) from the plurality of basal rate administration patterns displayed on the display unit 204 of the remote controller 200 as shown in FIG. 5A. To be done. This selection is made by the input unit 202.

Then, the controller calculation unit 208 calculates the remaining amount alert value X when issuing the remaining amount alert according to the condition (profile) of the patient (step S2). As described above, the remaining amount alert value X for issuing this alert differs depending on whether the patient is an adult or a child. Further, since the timing of medication varies depending on whether it is during normal times, during exercise, or during illness, it is necessary to calculate the optimum remaining amount alert value X that issues an alert during basal rate administration. It should be noted that the calculation of the remaining amount alert value X when issuing this alert may be performed by the main body calculation unit 108 of the drug solution administration device 100.

In this case, the main body calculation unit 108 calculates based on the total daily dose of the basal rate according to the patient stored in the data storage unit 106. For example, as described above, if the patient is a child, the total daily dose of the basal rate is 10.20 U, the frequency of replacement of the disposable 12 is once every three days, and the margin including the bolus amount is 2 Doubling and calculating a total dose of 61.2 U for 3 days. Then, when the total dose of 31.2 days, which is 61.2 U, is ¼, which is 15.3 U, that is, when X=15.3 U, the remaining amount alert is set to be issued.

It should be noted that, as described above, it is common to set the residual amount alert value X of the alerting chemical solution to, for example, 50 U in the adult basal rate administration pattern in normal times. Therefore, as shown in FIG. 3, the position of the remaining amount switch (predetermined position detection sensor 76 in FIG. 2) is set to a fixed value, for example, 50 U regardless of whether or not a remaining amount alert is generated. Set to the position.

Next, the main body calculation unit 108 determines whether or not the calculated remaining amount alert value X is less than 50 U (step S3). In step S3, when the main body calculation unit 108 determines that the remaining amount alert value X is 50 U or more (NO in step S3), the liquid medicine administration is started (step S4), and the remaining amount of the liquid medicine is the predetermined value 50U. When it becomes, the remaining amount switch for issuing the remaining amount alert is used (step S5). Note that step S4 and step S5 do not have to be in this order. It does not matter if the "use of the remaining amount switch" in step S5 is brought before the "start of drug solution administration" in step S4.

Then, the drug solution is administered to the patient, the slide unit 60 of FIG. 3 moves, and the main body operation unit 108 determines whether or not the remaining amount switch is pressed (step S6). If the remaining amount switch is not pressed in step S6 (NO in step S6), the process waits until it is pressed. When the remaining amount switch is pressed in step S6 (YES in step S6), the remaining amount detection unit 103 outputs a detection signal to the main body calculation unit 108. Then, the main body calculation unit 108 outputs the remaining amount alert signal to the output unit 104 and the remote controller 200. The output unit 104, the output unit 203 of the remote controller 200, and the display unit 204 notify the patient as a remaining amount alert that the remaining amount value of the drug solution in the cylindrical body 18 has reached the predetermined value 50U (step S7). ), the processing ends.

Next, when it is determined in step S3 that the calculated remaining amount alert value X is less than the predetermined value 50U (YES in step S3), the main body calculation unit 108 leaves the value for issuing the remaining amount alert. The amount alert value X is set (step S8), and administration of the liquid medicine is started (step S9).
After that, when the administration of the liquid medicine progresses, the main body calculation unit 108 determines whether or not the remaining amount switch is pressed by the slide unit 60 (step S10). The determination in step S10 is not always necessary when the remaining amount alert value X for issuing an alert is less than 50U. Here, even if the remaining amount switch is pressed, the remaining amount alert is not generated.

That is, since the remaining amount switch is merely used as a predetermined position detection switch, the position of the remaining amount switch is always guided by the sliding portion 60 of FIG. 3 regardless of whether or not a remaining amount alert is issued. The wall 68 is set at a predetermined position (position where the remaining amount of the chemical liquid is 50 U). Therefore, if the remaining amount alert value X for generating an alert is less than 50 U, the remaining amount alert signal is not output even if the remaining amount switch is pressed.

When the remaining amount switch is pressed in step S10 (YES in step S10), the main body calculation unit 108 starts counting the remaining amount of the chemical liquid in the tubular body 18 after the remaining amount switch is pressed (step S10). S11). This counting is performed, for example, by the counter unit of the remaining amount detecting unit 103 based on the number of rotations of the motor 44. Alternatively, the amount of movement of the plunger 20 may be calculated from the number of rotations of the motor 44 counted by the counter unit of the remaining amount detecting unit 103, and the remaining amount of the chemical liquid may be counted. Although an example of counting the number of rotations of the motor 44 as the counter unit has been described, the present invention is not limited to this, and the number of rotations of the feed screw shaft 22 may be counted as the counter unit, or the movement of the plunger 20 may be performed. The amount may be counted directly.

Next, the main body calculation unit 108 determines whether or not the remaining amount count value in step S11 is equal to the remaining amount alert value X for issuing an alert (step S12). Here, the remaining amount count value is the amount of chemical liquid calculated from the remaining amount (50 U) at the position of the remaining amount switch based on the rotation speed of the motor 44 counted by the counter unit of the remaining amount detecting unit 103, that is, The value is the value obtained by subtracting the amount of the chemical solution sent after pressing the remaining amount switch. The process of step S12 is repeated until the remaining amount count value reaches the remaining amount alert value X for issuing an alert (NO in step S12). Then, in step S12, when the remaining amount count value reaches the remaining amount alert value X for issuing an alert (YES in step S12), the main body calculation unit 108 of the drug administration device 100 outputs the remaining amount alert signal to the output unit 104. Or output to the remote controller 200. Accordingly, the alert sound is generated by the alert unit 78, or the remaining amount alert is displayed on the display unit 204 of the remote controller 200 via the main body communication unit 107, and the remaining amount alert is notified to the patient. (Step S7).

In the example of FIG. 7, the remaining amount switch is pressed after the start of the chemical liquid administration in step S9, and then the remaining amount counting in step S11 is started. However, when the remaining amount alert value X for issuing the remaining amount alert is less than the predetermined value 50U, it is possible to start the remaining amount count regardless of the pressing of the remaining amount switch.
For example, the remaining amount count in step S11 can be started at the timing of starting the liquid medicine administration in step S9. However, in this case, it is necessary to accurately know the full amount of the liquid medicine filled from the introduction port 26 into the cylindrical body 18. This is because the full amount of drug solution varies depending on the user and the profile of the same user. Also, it is difficult to know the exact full amount when the bubbles in the tubular body 18 are removed.

Although the embodiment example of the present invention has been described above, the chemical solution administration device and the chemical solution administration method of the present invention are not limited to the embodiment described herein, and are within the scope of the present invention described in the claims. Various changes are possible. For example, in FIG. 6, the chemical solution administration device 100 and the remote controller 200 are shown as connected to each other via a network, but the configuration of the controller 200 is incorporated into the chemical solution administration device 200 to form an integrated chemical solution administration device. Can also

In the above-described embodiment, an example in which an insulin pump that administers insulin is applied as the drug solution administration device has been described, but the invention is not limited to this. As the drug solution to be administered, various other drug solutions such as analgesics, anti-cancer therapeutic agents, HIV drugs, iron chelating agents, pulmonary hypertension therapeutic agents and the like may be used.

DESCRIPTION OF SYMBOLS 1... Chemical liquid administration support system, 100... Chemical liquid administration device (pump main body), 200... Remote controller, 300... Terminal device, 12... Disposable part, 14... Reuse part, 16... Base part, 18... Cylindrical body, 20... Plunger , 26... Introduction port, 28... Outflow port, 24... Nut part, 40... Drive part, 42... Battery, 52... Transmission shaft, 60... Slide part, 22... Feed screw shaft, 70... Lid body, 72... Control part , 78... Alert unit, 76... Predetermined position detection sensor (remaining amount switch), 74... Initial position detection sensor, 101, 201... Power supply unit, 102... Driving unit, 103... Remaining amount detection unit, 104, 203... Output unit , 105, 205... Date/time management section, 106, 206... Data storage section, 107... Main body communication section, 108... Main body calculation section, 202... Input section, 204... Display section, 207... Controller communication section, 208... Controller calculation section

Claims

A liquid medicine administration device that issues a remaining amount alert when the amount of liquid medicine in the cylinder reaches a predetermined value,
A calculation unit that calculates a remaining amount value that issues a remaining amount alert from the total dose of the liquid medicine, and outputs a remaining amount alert signal,
A notification unit that issues the remaining amount alert based on the remaining amount alert signal output by the calculation unit,
Equipped with
The arithmetic unit is
When the calculated remaining amount value is equal to or more than a predetermined value, the remaining amount alert signal is output to the notification unit when the remaining amount of the chemical liquid reaches the predetermined value,
When the calculated remaining amount value is less than the predetermined value, the remaining amount of the chemical liquid is counted, and when the count value reaches the calculated remaining amount value, the remaining amount alert signal is notified. Output to
Drug delivery device.
A remaining amount switch is provided to detect the remaining amount of the liquid medicine in the cylinder,
When the remaining amount value for outputting the remaining amount alert signal is equal to or more than the predetermined value, the arithmetic unit outputs the remaining amount alert signal at the timing of pressing the remaining amount switch,
The drug solution administration device according to claim 1.
The calculation unit starts counting the remaining amount of the chemical liquid when the remaining amount switch is pressed when the remaining amount value that outputs the calculated remaining amount alert signal is less than the predetermined value. The drug solution administration device described.
When the remaining amount value that outputs the calculated remaining amount alert signal is less than the predetermined value, the calculation unit starts the basal rate administration according to the basal rate administration pattern regardless of the pressing of the remaining amount switch. From the time point, start counting the remaining amount of the drug solution,
The drug solution administration device according to claim 2.
The drug solution administration device according to claim 1, wherein the notification unit emits the remaining amount alert by vibration, sound, display, or a combination thereof.
A counter unit for counting the amount of movement of the plunger moving in the cylinder is provided,
The drug solution administration device according to any one of claims 1 to 5, wherein the calculation unit counts the remaining amount of the drug solution from the movement amount of the plunger counted by the counter unit.
A storage unit for storing a basal rate administration pattern for administering the drug solution is provided.
7. The liquid medicine administration device according to claim 1, wherein the arithmetic unit calculates a total dose of the liquid medicine based on the basal rate administration pattern.
A method for administering a liquid medicine that issues a remaining amount alert when the remaining amount of liquid medicine in the cylinder reaches a predetermined value,
A step of calculating a remaining amount value of the liquid medicine that issues a remaining amount alert from the total dose of the liquid medicine by a calculation unit;
When the remaining amount value for issuing the remaining amount alert is equal to or more than the predetermined value, a step of outputting a remaining amount alert signal by the computing unit when the remaining amount of the chemical liquid reaches the predetermined value,
When the remaining amount value for issuing the remaining amount alert is less than the predetermined value, when the remaining amount of the chemical liquid reaches the predetermined value, the step of starting the counting of the remaining amount of the chemical liquid by the calculation unit, When the count value reaches the remaining amount value for issuing the remaining amount alert, outputting a remaining amount alert signal by the calculation unit,
A method for administering a liquid medicine containing: