JP6752267B2 - Chemical administration device - Google Patents

Description

The present invention relates to a portable drug solution administration device that is worn by a user to administer a drug solution.

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

In addition, in the drug solution administration device, the drug solution may not be normally administered to the user, and the drug solution may leak from the sticking portion. When a drug solution leaks, that is, a so-called liquid leak occurs, the amount of the drug solution administered to the user decreases, and the desired effect cannot be obtained, or the exact amount of the drug solution administered to the living body can be grasped. Since it was not possible, there was a problem that it was difficult to formulate a subsequent treatment policy. Furthermore, in the case of a drug solution administration device that is attached to the user's skin to administer the drug solution, when the drug solution adheres to the skin due to liquid leakage, mild skin symptoms such as redness, swelling, and pain occur. May cause serious skin disorders such as swelling, blisters, and necrosis, and there is a problem that the affixed portion attached to the user is easily peeled off by the leaked chemical solution.

In order to detect such a leakage of a chemical solution, for example, in the technique described in Patent Document 1, an electrode is provided near the infusion site where the chemical solution is administered, and the leakage is detected by a change in the impedance of the electrode. .. Further, in the technique described in Patent Document 1, a color-developing complex to be conveyed with a chemical solution is provided, and liquid leakage is detected by a change in the color of the color complex.

Special Table 2003-526479

However, in the technique described in Patent Document 1, the leakage of the chemical solution is constantly monitored, and the leakage is determined by the absolute value of the change in impedance and the change in the color complex. Therefore, the impedance and color complex may change due to factors different from the liquid leakage such as sweat and temperature change of the user, and there is a risk of erroneously detecting the chemical liquid leakage, and the detection accuracy of the chemical liquid leakage is low. ..

An object of the present invention is to provide a drug solution administration device capable of accurately detecting a leakage of a drug solution in consideration of the above problems.

In order to solve the above problems and achieve the object of the present invention, the drug solution administration device of the present invention includes an administration unit, a drive unit, a detection unit, an impedance measurement unit, a calculation unit, and a storage unit. There is. The administration department administers the drug solution to the user. The drive unit delivers the drug solution to the administration unit. The detection unit is provided around the administration unit. The impedance measuring unit measures the impedance of the detecting unit. The calculation unit controls the drive unit and the impedance measurement unit. The storage unit stores a threshold value for impedance information measured by the impedance measuring unit. Then, after the drive unit sends a predetermined amount of the chemical solution to the administration unit, the calculation unit determines whether or not the chemical solution is leaked based on the post-administration impedance information measured by the impedance measurement unit and the threshold value stored in the storage unit. ..

According to the drug solution administration device of the present invention, leakage of the drug solution can be accurately detected.

It is a block diagram which shows the control system of the drug solution administration apparatus which concerns on Example of Embodiment. It is explanatory drawing which shows the sticking part of the drug solution administration apparatus which concerns on Example of Embodiment. It is a flowchart which shows the 1st example of the liquid leakage detection in the chemical solution administration apparatus which concerns on embodiment. It is explanatory drawing which shows the administration pattern in the 1st example of the liquid leakage detection shown in FIG. It is a flowchart which shows the 2nd example of the liquid leakage detection in the chemical liquid administration apparatus which concerns on embodiment. It is explanatory drawing which shows the administration pattern in the 2nd example of the liquid leakage detection shown in FIG. It is a flowchart which shows the 3rd example of the liquid leakage detection in the chemical liquid administration apparatus which concerns on embodiment. It is explanatory drawing which shows the administration pattern in the 3rd example of the liquid leakage detection shown in FIG. It is a flowchart which shows the 4th example of the liquid leakage detection in the chemical liquid administration apparatus which concerns on embodiment. It is explanatory drawing which shows the administration pattern in the 4th example of the liquid leakage detection shown in FIG. It is a flowchart which shows the 5th example of the liquid leakage detection in the chemical liquid administration apparatus which concerns on embodiment. It is explanatory drawing which shows the administration pattern in the 5th example of the liquid leakage detection shown in FIG.

Hereinafter, examples of embodiments of the drug solution administration device of the present invention will be described with reference to FIGS. 1 to 12. The common members in each figure are designated by the same reference numerals. Moreover, the present invention is not limited to the following forms.

1. Configuration Example of Drug Solution Administration Device First, a configuration example of an embodiment of the drug solution administration device (hereinafter referred to as “this example”) will be described with reference to FIGS. 1 and 2.
FIG. 1 is a block diagram showing a control system of a drug solution administration device.

The drug solution administration device shown in FIG. 1 is a portable insulin for continuous administration of the drug solution into the user's body, such as a patch type insulin pump, a tube type insulin pump, and other portable drug solution administration devices. It is a pump 1. The insulin pump 1 includes a power supply unit 11, a drive unit 12, an impedance measurement unit 13, a communication unit 15, a storage unit 14, a date / time management unit 16, a calculation unit 17, a temperature measurement unit 18, and motion detection. It has a part 19. Further, the insulin pump 1 has a sticking portion 20 (see FIG. 2) that is stuck to the skin of the user.

The power supply unit 11 is for supplying electric power to each component constituting the insulin pump 1. The power supply unit 11 includes, for example, a battery, a battery box for accommodating the battery, a switch for turning on / off the power supply from the battery, and the like.

The drive unit 12 includes a syringe that houses a drug solution (insulin) to be administered, a pusher that slides in the syringe, a motor for moving the pusher, a drive mechanism, and the like. The drive of the drive unit 12 is controlled by the calculation unit 17.

The impedance measurement unit 13 is connected to the first electrode 22 and the second electrode 23, which will be described later. The impedance measuring unit 13 detects the resistance value or the capacitance between the first electrode 22 and the second electrode 23, and measures the impedance. Then, the impedance measurement unit 13 outputs the measured impedance information to the storage unit 14 and the calculation unit 17. Further, the impedance measurement timing in the impedance measurement unit 13 is controlled by the calculation unit 17.

The storage unit 14 is a unit that stores various types of data. The storage unit 14 stores an administration profile showing an administration pattern for administering the drug solution, a control program for controlling the impedance measuring unit 13 and the like, threshold data used for detecting liquid leakage, and the like. Further, the storage unit 14 stores information received by the communication unit 15, impedance information measured by the impedance measurement unit 13, date and time information acquired by the date and time management unit 16, temperature information measured by the temperature measurement unit 18, and the like. Will be done. Then, the storage unit 14 outputs the control program stored in advance, the impedance information received from another processing unit, and the like to the calculation unit 17.

The communication unit 15 is connected to a controller (not shown) for operating the insulin pump 1, an external portable information processing terminal, or a PC (personal computer) via a wired or wireless network. The communication unit 15 receives operation information operated by the user via a controller (not shown), a portable information processing terminal, or the like, and measurement data measured by an external device. Then, the communication unit 15 outputs the received operation information and measurement data to the calculation unit 17.

Further, the communication unit 15 is controlled by the calculation unit 17 to output liquid leakage information and various information related to the insulin pump 1 such as an administration pattern to a controller (not shown), a portable information processing terminal, or the like.

The date / time management unit 16 is a program portion for performing date / time management, may be mounted on a general microcomputer, and outputs date / time information based on a command from the calculation unit 17. The date and time management unit 16 outputs accurate date and time information by supplying electric power even when the power is off.

The calculation unit 17 is equipped with a program for controlling various devices such as a drive unit 12, an impedance measurement unit 13, a storage unit 14, a communication unit 15, a date / time management unit 16, a temperature measurement unit 18, and a motion detection unit 19. .. Then, the calculation unit 17 controls various operations of the insulin pump 1 based on the program. Further, the calculation unit 17 receives the information received by the communication unit 15 and the information measured and detected by the impedance measurement unit 13, the temperature measurement unit 18, and the motion detection unit 19. The calculation unit 17 stores the received information in the storage unit 14.

Further, the calculation unit 17 drives the driving unit 12 based on the administration profile showing the administration pattern of the drug solution stored in the storage unit 14. As a result, the drug solution based on the predetermined administration profile is administered to the user. The arithmetic unit 17 includes, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory), which are not shown here. The ROM may be the storage unit 14.

The temperature measuring unit 18 measures the body temperature of the user wearing the insulin pump 1, particularly the temperature around the first electrode 22 and the second electrode 23, based on the command from the calculation unit 17. The temperature measurement unit 18 outputs the measured temperature measurement value (temperature information) to the calculation unit 17 and the storage unit 14. As the temperature information, the temperature information received by the communication unit 15 from an external thermometer may be used.

The motion detection unit 19 includes, for example, a three-axis acceleration sensor, and detects the motion of a user wearing the insulin pump 1. When the user's motion is detected, the motion detection unit 19 outputs the detection information to the calculation unit 17. In addition, the motion detection unit 19 detects the orientation of the device body when the insulin pump 1 is attached to the user. Then, the motion detection unit 19 outputs the detected information regarding the orientation of the device main body to the calculation unit 17.

FIG. 2 is an explanatory diagram showing the configuration of the sticking portion 20.
As shown in FIG. 2, the sticking portion 20 is provided with an administration portion 21 in which a hollow puncture needle capable of puncturing the user's skin is projected. An adhesive layer (not shown) is provided around the sticking portion 20 to hold the sticking portion 20 on the patient's skin. The puncture needle may be a rigid metal needle or a flexible cannula. A drug solution is sent to the administration unit 21 from a syringe (not shown), and the drug solution is administered to the user. Further, around the administration unit 21, a first electrode 22 and a second electrode 23 showing an example of the liquid leakage detection unit are provided.

The first electrode 22 and the second electrode 23 are provided on the sticking surface of the insulin pump 1 to be stuck on the skin of the user. The first electrode 22 and the second electrode 23 are formed in a ring shape. The first electrode 22 is arranged so as to surround the administration portion 21. The second electrode 23 is arranged substantially concentrically with the first electrode 22 on the outer side in the radial direction of the first electrode 22. The first electrode 22 and the second electrode 23 are connected to the impedance measuring unit 13. When a liquid leak occurs and a chemical solution such as insulin invades between the first electrode 22 and the second electrode 23, the impedance between the first electrode 22 and the second electrode 23 changes.

In this example, an example in which the first electrode 22 and the second electrode 23 are formed in a ring shape and arranged on concentric circles of the administration unit 21 has been described, but the present invention is not limited to this. For example, a plurality of first electrodes and second electrodes may be arranged radially with respect to the administration unit 21, and the administration unit 21 may be located between the first electrode and the second electrode with the first electrode. A second electrode may be arranged. Alternatively, a plurality of punctate first electrodes and second electrodes may be arranged around the administration unit 21.

2. First Example of Liquid Leakage Detection Method Next, a first example of the liquid leakage detection method of the insulin pump 1 having the above-described configuration will be described with reference to FIGS. 3 and 4.
FIG. 3 is a flowchart showing a first example of liquid leakage detection, and FIG. 4 is an explanatory diagram showing an administration pattern in the first example of liquid leakage detection. In the administration pattern shown in FIG. 4, the vertical axis shows the flow rate of the drug solution passing through the administration unit 21, and the horizontal axis shows the time.

In the first example shown in FIGS. 3 and 4, the user is subjected to continuous administration, so-called basal administration, in which a fixed amount of the drug solution is continuously administered to the user over a day (24 hours). An example of bolus administration in which a predetermined amount of a drug solution is administered before eating a meal will be described. Bolus administration, which shows an example of predetermined dose administration, increases the amount of drug solution to be administered as compared with basal administration.

First, the calculation unit 17 determines whether the current time is the bolus start set time in the preset administration profile, or whether the bolus start command has been received via the communication unit 15 (step S11). .. In the process of step S11, when the calculation unit 17 determines that the current time is the bolus start set time or has received the bolus start command (YES determination in step S11), the calculation unit 17 controls the impedance measurement unit 13. Then, the impedance of the first time is measured (step S12).

The calculation unit 17 continues the process of step S11 until the current time reaches the bolus start set time or the bolus start command is received.

In the process of step S12, when the impedance measuring unit 13 measures the impedance for the first time, the impedance measuring unit 13 stores the measured first impedance information (impedance information before administration) T1 in the storage unit 14.

When the first impedance measurement by the impedance measuring unit 13 is completed, the calculation unit 17 controls the driving of the driving unit 12 and executes the bolus administration (step S13). As a result, as shown in FIG. 4, bolus administration is performed, and the flow rate of the drug solution passing through the administration unit 21 is increased.

Next, when the bolus administration of the predetermined time and the predetermined amount is completed, the calculation unit 17 controls the driving of the driving unit 12 and returns the dose to the basal administration. Then, the calculation unit 17 controls the impedance measurement unit 13 to measure the impedance for the second time (step S14).

In the process of step S14, when the impedance measuring unit 13 measures the impedance for the second time, the impedance measuring unit 13 outputs the measured second impedance information (impedance information after administration) T2 to the storage unit 14 or the calculation unit 17. To do.

When the second impedance measurement by the impedance measuring unit 13 is completed, the calculation unit 17 calculates the difference between the first impedance information T1 and the second impedance information T2 stored in the storage unit 14. Then, the calculation unit 17 determines whether or not the calculated difference value is larger than the threshold value stored in advance in the storage unit 14 (step S15).

Here, when liquid leakage occurs, the impedance between the first electrode 22 and the second electrode 23 decreases, and changes significantly before and after administration. In the process of step S15, when the calculation unit 17 determines that the calculated difference value is larger than the threshold value (YES determination in step S15), the calculation unit 17 determines that a liquid leak has occurred, and causes the communication unit 15 to operate. Instruct the external controller to output an alarm related to the occurrence of liquid leakage via the system. Then, the external controller outputs an alarm by vibration, sound, or the like to notify the user that a liquid leak has occurred (step S16). As a result, the liquid leakage detection process of the insulin pump 1 is completed.

Although an example of outputting an alarm from an external controller has been described, the present invention is not limited to this, and an output unit for outputting an alarm may be provided in the main body of the insulin pump 1. As the alarm, for example, vibration or sound may be performed alone, or vibration or sound may be used in combination.

Further, in the process of step S15, when the calculation unit 17 determines that the calculated difference value is smaller than the threshold value (NO determination in step S15), the calculation unit 17 ends the liquid leakage detection process. As a result, the liquid leakage detection process of the insulin pump 1 is completed.

According to the liquid leakage detection method in the first example, the change in impedance is detected before and after the administration of the bolus, and the amount of the change is compared with the threshold value to detect the liquid leakage. That is, the change in impedance after administration is judged relative to the impedance before administration. As a result, erroneous detection caused by the external environment can be prevented, and the accuracy of liquid leakage detection can be further improved.

Further, an alarm may be output when the first impedance information, which is the impedance information before administration measured in the process of step S12, is larger than a preset threshold value. As a result, it is possible to determine the abnormality around the administration unit 21 before the bolus administration, and the bolus administration can be performed normally. The threshold value used at this time may be the same value as the threshold value used in the process of step S15, or may be set to a different value.

3. Second Example of Liquid Leakage Detection Method Next, a second example of the liquid leakage detection method will be described with reference to FIGS. 5 and 6.
FIG. 5 is a flowchart showing a second example of liquid leakage detection, and FIG. 6 is an explanatory diagram showing an administration pattern in the second example of liquid leakage detection.

The liquid leakage detection method according to the second example shown in FIG. 5 does not perform impedance measurement before administering the bolus to the liquid leakage detection method according to the first example. Therefore, the description of the steps common to the liquid leakage detection method according to the first example will be omitted.

First, the calculation unit 17 determines whether the current time is the bolus start set time in the preset administration profile, or whether the bolus start command has been received via the communication unit 15 (step S21). .. In the process of step S21, when the calculation unit 17 determines that the current time is the bolus start set time or has received the bolus start command (YES determination in step S21), the calculation unit 17 drives the drive unit 12. Control and perform bolus administration (step S22). As a result, as shown in FIG. 6, bolus administration is performed, and the flow rate of the drug solution passing through the administration unit 21 is increased.

Next, when the bolus administration is completed, the calculation unit 17 controls the drive of the drive unit 12 and returns the dose to the basal administration. Then, the calculation unit 17 controls the impedance measurement unit 13 to measure the impedance for the first time (step S23). In the process of step S23, when the impedance measurement unit 13 measures the impedance for the first time, the impedance measurement unit 13 outputs the measured first impedance information (impedance information after administration) T1 to the storage unit 14 and the calculation unit 17. To do.

Next, the calculation unit 17 determines whether or not the value of the first impedance information T1, which is the post-administration impedance information, is smaller than the threshold value stored in advance in the storage unit 14 (step S24). Here, when liquid leakage occurs, the impedance after administration between the first electrode 22 and the second electrode 23 decreases, and changes significantly from the threshold value which is the reference value.

In the process of step S24, when the calculation unit 17 determines that the first impedance information T1 is smaller than the threshold value (YES determination in step S24), the calculation unit 17 leaks liquid to the external controller via the communication unit 15. Instruct the output of the alarm related to the occurrence (step S25). As a result, the liquid leakage detection process of the insulin pump 1 is completed.

Further, in the process of step S24, when the calculation unit 17 determines that the first impedance information T1 is larger than the threshold value (NO determination in step S24), the calculation unit 17 ends the liquid leakage detection process. As a result, the liquid leakage detection process of the insulin pump 1 is completed.

According to the liquid leakage detection method in the second example, the impedance is measured after the bolus is administered, that is, after a predetermined amount of the drug solution is administered. Then, the liquid leakage is detected based on the difference between the impedance information after administration and the threshold value which is a reference value. In the liquid leakage detection method in this second example, the threshold value, which is a reference value, is used as impedance information before administration.

That is, also in the liquid leakage detection method in the second example, the impedance information measured by the impedance measuring unit 13 is determined as a relative value, as in the liquid leakage detection method in the first example. As a result, compared to the conventional liquid leakage detection method in which impedance is constantly measured and liquid leakage is determined by the absolute value of impedance information, erroneous detection caused by the external environment can be prevented, and the accuracy of liquid leakage detection can be improved. Can be improved.

4. Third Example of Liquid Leakage Detection Method Next, a third example of the liquid leakage detection method will be described with reference to FIGS. 7 and 8.
FIG. 7 is a flowchart showing a third example of liquid leakage detection, and FIG. 8 is an explanatory diagram showing an administration pattern in the third example of liquid leakage detection.

Here, when the temperature rises, sweating is promoted. Then, when the sweat secreted between the first electrode 22 and the second electrode 23 invades, the impedance between the first electrode 22 and the second electrode 23 changes. Therefore, the liquid leakage detection method according to the third example shown in FIG. 7 is a liquid leakage detection method in consideration of temperature information. The description of the steps common to the liquid leakage detection method according to the first example and the second example will be omitted. A plurality of threshold values set based on the temperature information are stored in the storage unit 14 in advance.

First, the calculation unit 17 determines whether the current time is the bolus start set time in the preset administration profile, or whether the bolus start command has been received via the communication unit 15 (step S31). .. In the process of step S31, when the calculation unit 17 determines that the current time is the bolus start set time or has received the bolus start command (YES determination in step S31), the calculation unit 17 drives the drive unit 12. Control and perform bolus administration (step S32). As a result, as shown in FIG. 8, bolus administration is performed, and the flow rate of the drug solution passing through the administration unit 21 is increased.

Next, the calculation unit 17 controls the temperature measurement unit 18 and measures the ambient temperature of the first electrode 22 and the second electrode 23 (step S34). In the process of step S34, the temperature measuring unit 18 outputs the measured temperature information to the storage unit 14 and the calculation unit 17.

Next, when the temperature measurement by the temperature measurement unit 18 is completed, the calculation unit 17 controls the impedance measurement unit 13 to measure the impedance for the first time (step S35).

Next, the calculation unit 17 selects a threshold value to be used for liquid leakage determination from a plurality of threshold values stored in advance in the storage unit 14 based on the temperature measurement value by the temperature measurement unit 18 (step S36). The threshold value selection process in step S36 may be performed before the impedance measurement process after administration in step S35. Further, the impedance measurement process after the administration in step S35 may be performed before the temperature measurement process in step S34.

Next, the calculation unit 17 determines whether or not the value of the first impedance information T1, which is the post-administration impedance information, is smaller than the threshold value selected in the process of step S36 (step S37). In the process of step S37, when the calculation unit 17 determines that the first impedance information T1 is smaller than the threshold value (YES determination in step S37), the calculation unit 17 leaks liquid to the external controller via the communication unit 15. Instructing the output of the alarm related to the occurrence (step S38). As a result, the liquid leakage detection process of the insulin pump 1 is completed.

Further, in the process of step S37, when the calculation unit 17 determines that the first impedance information T1 is larger than the threshold value (NO determination in step S37), the calculation unit 17 ends the liquid leakage detection process. As a result, the liquid leakage detection process of the insulin pump 1 is completed.

According to the liquid leakage detection method in the third example, the threshold value is based on the ambient temperature of the first electrode 22 and the second electrode 23, which are the detection units after the bolus administration, that is, after the predetermined amount of the drug solution is administered. Is set. As a result, the amount of change in impedance caused by sweat can be taken into consideration, and the accuracy of liquid leakage detection can be further improved.

Further, in the liquid leakage detection method according to the third example, the impedance is measured before the bolus administration, and the impedance information before administration and the impedance information after administration are obtained, as in the liquid leakage detection method according to the first example. The difference may be calculated.

5. Fourth Example of Liquid Leakage Detection Method Next, a fourth example of the liquid leakage detection method will be described with reference to FIGS. 9 and 10.
FIG. 9 is a flowchart showing a fourth example of liquid leakage detection, and FIG. 10 is an explanatory diagram showing an administration pattern in the fourth example of liquid leakage detection.

In the fourth example shown in FIGS. 9 and 10, a predetermined amount of chemical solution is used as a test so that the leakage can be detected whenever a leakage is suspected without being restricted to the bolus administration before meals. An example of administering the above will be described. Therefore, the description of the steps common to the liquid leakage detection method according to the first example will be omitted.

First, the calculation unit 17 determines whether the current time is the test start setting time in the preset administration profile, or whether the test start command is received via the communication unit 15 (step S41). .. In the process of step S41, when the calculation unit 17 determines that the current time is the test start set time or has received the test start command (YES determination in step S41), the calculation unit 17 controls the impedance measurement unit 13. Then, the impedance of the first time is measured (step S42). When the impedance measuring unit 13 measures the impedance for the first time, the impedance measuring unit 13 stores the measured first impedance information (impedance information before administration) T1 in the storage unit 14.

When the first impedance measurement by the impedance measuring unit 13 is completed, the calculation unit 17 controls the driving of the driving unit 12 and executes a test administration showing an example of a predetermined amount administration for a predetermined time. Then, when the test administration for a predetermined time is completed, the calculation unit 17 controls the driving of the driving unit 12 and restarts the basal administration (step S43). As a result, as shown in FIG. 10, test administration is performed, and the flow rate of the drug solution passing through the administration unit 21 is temporarily increased. In addition, the calculation unit 17 stores the increased amount U1 of the drug solution increased during the test administration in the storage unit 14. The increased amount U1 may be stored in the storage unit 14 in advance before the test administration is executed.

Next, when the test administration is completed and the basal administration is restarted, the calculation unit 17 controls the impedance measurement unit 13 to measure the impedance for the second time (step S44).

In the process of step S44, when the impedance measurement unit 13 measures the impedance for the second time, the impedance measurement unit 13 outputs the measured second impedance information (impedance information after administration) T2 to the storage unit 14 or the calculation unit 17. To do.

Next, the calculation unit 17 calculates the difference between the first impedance information T1 and the second impedance information T2, and determines whether or not the calculated difference value is larger than the threshold value stored in advance in the storage unit 14. (Step S45).

In the process of step S45, when it is determined that the difference value calculated by the calculation unit 17 is larger than the threshold value (YES determination in step S45), the calculation unit 17 determines that a liquid leak has occurred, and via the communication unit 15. Instructs the external controller to output an alarm related to the occurrence of liquid leakage. Then, the external controller outputs an alarm by vibration, sound, or the like to notify the user that a liquid leak has occurred (step S46). When the alarm is output, the calculation unit 17 performs the process of step S47, which will be described later.

Further, in the process of step S45, when it is determined that the difference value calculated by the calculation unit 17 is smaller than the threshold value (NO determination in step S45), the calculation unit 17 controls the drive of the drive unit 12 and administers the compensation period. To carry out. Then, when the execution of the compensation period administration is completed, the calculation unit 17 controls the drive of the drive unit 12 and restarts the basal administration (step S47). As a result, the liquid leakage detection process is completed when the test administration is performed.

Here, when the test administration is carried out in the treatment of step S43, the dose of the drug solution is increased as compared with the case of normal basal administration. Then, it is necessary to reduce the amount of the drug solution increased at the time of the test administration by the same amount as the amount U1 at the time of the basal administration after the test administration. Therefore, in the compensation period administration in the treatment of step S47, the reduced amount U2 is reduced from the basal dose. This decrease amount U2 is the same amount as the increase amount U1 of the drug solution increased at the time of test administration. As a result, even if the dose of the drug solution is temporarily increased other than the bolus administration, it is possible to prevent the daily dose of the drug solution from changing. Since the insulin amount that does not cause hypoglycemia by the test administration is selected as the increase amount U1 of the drug solution, the liquid leakage can be detected with a drug solution amount smaller than the normal bolus dose. Therefore, by carrying out several test administrations in which the increased amount U1 is different, the upper limit value of the dose that causes liquid leakage can be investigated, which can be useful for setting the upper limit value of the predetermined amount in the bolus administration.

According to the liquid leakage detection method shown in the fourth example, even when the test administration is carried out, the liquid leakage can be detected accurately as in the liquid leakage detection method at the time of bolus administration shown in the first example. it can.

6. Fifth Example of Liquid Leakage Detection Method Next, a fifth example of the liquid leakage detection method will be described with reference to FIGS. 11 and 12.
FIG. 11 is a flowchart showing a fifth example of liquid leakage detection, and FIG. 12 is an explanatory diagram showing an administration pattern in the fifth example of liquid leakage detection.

The liquid leakage detection method according to the fifth example shown in FIG. 11 is to detect a leak during exercise after bolus administration by using the detection information from the exercise detection unit 19. The description of the steps common to the liquid leakage detection method according to the first example will be omitted.

First, the calculation unit 17 determines whether the current time is the bolus start set time in the preset administration profile, or whether the bolus start command has been received via the communication unit 15 (step S51). .. In the process of step S51, when the calculation unit 17 determines that the current time is the bolus start set time or has received the bolus start command (YES determination in step S51), the calculation unit 17 controls the impedance measurement unit 13. Then, the impedance of the first time is measured (step S52).

Next, the calculation unit 17 controls the drive of the drive unit 12 and executes the bolus administration (step S53). Then, when the bolus administration of the predetermined time and the predetermined amount is completed, the calculation unit 17 controls the impedance measurement unit 13 and measures the impedance for the second time (step S54).

Next, the calculation unit 17 calculates the difference between the first impedance information T1 and the second impedance information T2, and determines whether or not the calculated difference value is larger than the threshold value stored in advance in the storage unit 14. (Step S55). In the process of step S55, when the calculation unit 17 determines that the difference value is larger than the threshold value (YES determination in step S55), the calculation unit 17 determines that a liquid leak has occurred, and via the communication unit 15. Instructs an external controller to output an alarm related to the occurrence of liquid leakage. Then, the external controller outputs an alarm by vibration, sound, or the like to notify the user that a liquid leak has occurred (step S56). As a result, the liquid leakage detection process is completed.

Further, in the process of step S55, when the calculation unit 17 determines that the difference value is smaller than the threshold value (NO determination in step S55), the calculation unit 17 causes the motion detection unit 19 to perform motion during the motion detection period Q1. It is determined whether or not it has been detected (step S57). As shown in FIG. 12, the exercise detection period Q1 is a predetermined time after the bolus administration is performed. The exercise detection period Q1 may be constant regardless of the dose in the bolus administration, but the time may be adjusted based on the dose in the bolus administration. For example, when the bolus dose is small, the exercise detection period Q1 may be set short, and when the bolus dose is large, the exercise detection period Q1 may be set long. Further, as an example of motion detection, the square root of the sum of squares of each axis of the 3-axis acceleration sensor is integrated for several seconds, for example, 5 seconds, and when this integrated value exceeds a preset threshold value, it is determined that there is motion. You may.

In the process of step S57, if the motion detection unit 19 does not detect the motion during the motion detection period Q1 (NO determination in step S57), the liquid leakage detection process ends.

Further, in the process of step S57, when the motion detection unit 19 detects the user's motion during the motion detection period Q1 (YES determination in step S57), the calculation unit 17 controls the impedance measurement unit 13 for the third time. (Step S58).

In the process of step S58, when the impedance measuring unit 13 measures the impedance for the third time, the impedance measuring unit 13 outputs the measured third impedance information (impedance information during exercise) T3 to the storage unit 14 or the calculation unit 17. To do.

Next, the calculation unit 17 calculates the difference between the first impedance information T1 and the third impedance information T3. Then, the calculation unit 17 determines whether or not the calculated difference value is larger than the threshold value stored in advance in the storage unit 14 (step S59). The threshold value used in the process of step S59 may be the same value as the threshold value used in the process of step S55, or may be a different value.

Here, when the drug solution when the bolus is administered leaks from the punctured portion of the skin of the user due to the exercise of the user, the impedance between the first electrode 22 and the second electrode 23 changes. .. Then, in the process of step 59, when the calculation unit 17 determines that the difference value between the calculated first impedance information T1 and the third impedance information T3 is larger than the threshold value (YES determination in step S59), the calculation unit 17 , It is determined that a liquid leak has occurred, and an alarm is output (step S60). The alarm output in step S56 and the alarm output in step S60 may have the same sound or vibration, or may have different sounds or vibrations. As a result, the liquid leakage detection process is completed.

Further, in the process of step S59, when the calculation unit 17 determines that the calculated difference value is smaller than the threshold value (NO determination in step S59), the calculation unit 17 states that no liquid leakage has occurred during exercise. to decide. As a result, the liquid leakage detection process is completed.

According to the liquid leakage detection method in the fifth example, the presence or absence of liquid leakage that occurs during exercise can be determined by detecting the movement of the user after the bolus administration, that is, after the administration of a predetermined amount of the drug solution. .. Further, in the liquid leakage detection method in the fifth example described above, an example of determining a liquid leakage during one exercise in the exercise detection period Q1 has been described, but the present invention is not limited to this. For example, during the motion detection period Q1, each time the motion detection unit 19 detects the user's motion, the impedance may be measured to detect the liquid leakage.

Further, in the liquid leakage detection method in the fifth example, the temperature information measured by the temperature measuring unit 18 may be used in the same manner as in the liquid leakage detection method in the third example. That is, the threshold value used for determining the presence or absence of liquid leakage in the processes of steps S55 and S59 may be set based on the temperature information measured by the temperature measuring unit 18.

The embodiments of the present invention have been described above, including their effects. However, the drug solution administration device of the present invention is not limited to the above-described embodiment, and various modifications can be made without departing from the gist of the invention described in the claims.

In the above-described embodiment, an example in which an insulin pump for administering insulin is applied as a drug solution administration device has been described, but the present invention is not limited to this. As the drug solution to be administered, various other drug solutions such as analgesics, anticancer drugs, HIV drugs, iron chelating drugs, and pulmonary hypertension drugs may be used.

Further, the threshold value used at the time of determining the liquid leakage may be set based on the information regarding the orientation of the device main body detected by the motion detection unit 19.

1 ... Insulin pump (drug administration device), 11 ... Power supply unit, 12 ... Drive unit, 13 ... Impedance measurement unit, 14 ... Storage unit, 15 ... Communication unit, 16 ... Date and time management unit, 17 ... Calculation unit, 18 ... Temperature Measurement unit, 19 ... motion detection unit, 20 ... pasting unit, 21 ... administration unit, 22 ... first electrode (detection unit), 23 ... second electrode, Q1 ... motion detection period

Claims (5)

The administration part that administers the drug solution to the user,
A driving unit that delivers the drug solution to the administration unit,
A detection unit provided around the administration unit and
An impedance measurement unit that measures the impedance of the detection unit and
A temperature measuring unit that measures the temperature of the detection unit and
An arithmetic unit that controls the drive unit and
It is provided with a storage unit for storing a plurality of preset threshold values based on temperature information, which is related to impedance information measured by the impedance measuring unit.
The calculation unit acquires temperature information measured by the temperature measurement unit when the drive unit sends a predetermined amount of a chemical solution to the administration unit, and a plurality of storage units stored in the storage unit based on the temperature information. A threshold value to be used for determining leakage of the drug solution is selected from the threshold value, and after the driving unit sends a predetermined amount of the drug solution to the administration unit, the post-administration impedance information measured by the impedance measurement unit and stored in the storage unit. A drug solution administration device that determines the presence or absence of leakage of the drug solution based on the selected threshold value. The calculation unit acquires pre-administration impedance information measured by the impedance measuring unit before the driving unit delivers a predetermined amount of the drug solution to the administration unit, and obtains the post-administration impedance information, the pre-administration impedance information, and the above-mentioned pre-administration impedance information. The drug solution administration device according to claim 1, wherein the presence or absence of leakage of the drug solution is determined based on a threshold value. The administration part that administers the drug solution to the user,
A driving unit that delivers the drug solution to the administration unit,
A detection unit provided around the administration unit and
An impedance measurement unit that measures the impedance of the detection unit and
A motion detection unit that detects the user's motion,
An arithmetic unit that controls the drive unit and
A storage unit for storing a threshold value for impedance information measured by the impedance measurement unit is provided.
After the driving unit sends a predetermined amount of the chemical solution to the administration unit , the calculation unit leaks the chemical solution based on the post-administration impedance information measured by the impedance measurement unit and the threshold value stored in the storage unit. When the motion detection unit detects the user's motion, the impedance measurement section acquires the motion impedance information measured by the impedance measurement section, and stores the impedance information during the motion and the storage unit. A drug solution administration device that determines the presence or absence of leakage of the drug solution based on the threshold value. The drug solution administration device according to claim 3 , wherein the motion detection unit detects the user's motion during a predetermined period after administering a predetermined amount of the drug solution to the user. The calculation unit controls the driving unit to continuously administer a constant amount of the drug solution to the user and to administer a predetermined amount of the drug solution to the user in an amount increased from the continuous administration. The drug solution administration device according to any one of claims 1 to 4 , wherein the amount of the drug solution in the continuous administration is reduced by the amount increased by the predetermined amount administration.

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