JPWO2017154503A1 - Chemical solution administration device - Google Patents

Abstract

  The chemical solution administration device includes an administration unit, a drive unit, a detection unit, an impedance measurement unit, a calculation unit, and a storage unit. After the driving unit sends out a predetermined amount of the drug solution to the administration unit, the calculation unit determines whether there is a leak of the drug solution based on the post-administration impedance information measured by the impedance measurement unit and the threshold value stored in the storage unit.

Description

  The present invention relates to a portable portable liquid medicine administration device that is attached to a user and administers a liquid medicine.

  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 diabetic patients, a treatment in which a minute amount of insulin is continuously infused into the body of the patient is performed. In this treatment method, in order to administer a drug solution (insulin) to a patient throughout the day, a portable drug solution administration device (so-called insulin pump) that can be fixedly carried on the patient's body or clothes is used.

  Further, in the chemical solution administration device, the chemical solution may not leak normally to the user, and the chemical solution may leak from the sticking part. When a chemical leak, the so-called leak, occurs, the amount of the chemical administered to the user decreases, and the desired effect cannot be obtained or the exact amount of the chemical administered to the living body can be grasped. Since it was not possible, it was difficult to make a subsequent treatment policy. In addition, in the case of a drug administration device that administers a drug solution by attaching it to the user's skin, if the drug solution adheres to the skin due to a liquid leak, the drug solution is an anticancer therapeutic agent because of mild skin symptoms such as redness, swelling, and pain. May cause serious skin damage such as swelling, blistering, or necrosis, and there is a problem that the applied part attached to the user is easily peeled off by the leaked chemical solution.

  In order to detect such a leakage of the 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 of the liquid is detected by a change in impedance of the electrode. . Moreover, in the technique described in patent document 1, the color complex which conveys with a chemical | medical solution is provided, and the liquid leak is detected by the change of the color of this color complex.

Special table 2003-526479 gazette

  However, in the technique described in Patent Document 1, leakage of a chemical solution is always monitored, and the leakage is determined based on the absolute value of the change in impedance and the change in the color complex. For this reason, impedance and color complex may change due to factors different from the user's leak such as sweat or temperature change, and there is a possibility that the leak of the chemical solution may be detected incorrectly, and the detection accuracy of the leak of the chemical solution has been low. .

  An object of the present invention is to provide a drug solution administration device that can accurately detect leakage of a drug solution in consideration of the above-described problems.

  In order to solve the above-described problems and achieve the object of the present invention, a 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. Yes. The administration unit administers a drug solution to the user. A drive part sends out a chemical | medical solution to an administration part. The detection unit is provided around the administration unit. The impedance measurement unit measures the impedance of the detection unit. The calculation unit controls the drive unit and the impedance measurement unit. The storage unit stores a threshold value relating to impedance information measured by the impedance measuring unit. Then, after the drive unit sends out a predetermined amount of the drug solution to the administration unit, the calculation unit determines whether there is a leak of the drug solution 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 chemical solution administration device of the present invention, it is possible to accurately detect the leakage of the chemical solution.

It is a block diagram which shows the control system of the chemical | medical solution administration apparatus concerning the embodiment. It is explanatory drawing which shows the sticking part of the chemical | medical solution administration device concerning the embodiment. It is a flowchart which shows the 1st example of the liquid leak detection in the chemical | medical solution administration device concerning an embodiment. It is explanatory drawing which shows the administration pattern in the 1st example of the liquid leak detection shown in FIG. It is a flowchart which shows the 2nd example of the liquid leak detection in the chemical | medical solution administration device concerning an embodiment. It is explanatory drawing which shows the administration pattern in the 2nd example of the liquid leak detection shown in FIG. It is a flowchart which shows the 3rd example of the liquid leak detection in the chemical | medical solution administration device concerning an embodiment. It is explanatory drawing which shows the administration pattern in the 3rd example of the liquid leak detection shown in FIG. It is a flowchart which shows the 4th example of the liquid leak detection in the chemical | medical solution administration device concerning an embodiment. It is explanatory drawing which shows the administration pattern in the 4th example of the liquid leak detection shown in FIG. It is a flowchart which shows the 5th example of the liquid leak detection in the chemical | medical solution administration device concerning an embodiment. It is explanatory drawing which shows the administration pattern in the 5th example of the liquid leak detection shown in FIG.

  Hereinafter, embodiments of the drug solution administration device of the present invention will be described with reference to FIGS. In addition, the same code | symbol is attached | subjected to the common member in each figure. The present invention is not limited to the following form.

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

  The medicinal solution administration device shown in FIG. 1 is a portable insulin for continuously administering a medicinal solution into a user's body, such as a patch-type or tube-type insulin pump and other portable medicinal solution administration devices. 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 and time management unit 16, a calculation unit 17, a temperature measurement unit 18, and a motion detection. Part 19. Moreover, the insulin pump 1 has the sticking part 20 (refer FIG. 2) stuck on a user's skin.

  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 that houses the battery, and a switch that turns on / off power supply from the battery.

  The drive unit 12 includes a syringe that stores a drug solution (insulin) to be administered, a pusher that is slid in the syringe, a motor that moves the pusher, a drive mechanism, and the like. The driving of the driving unit 12 is controlled by the calculation unit 17.

  The impedance measuring unit 13 is connected to a first electrode 22 and a second electrode 23 described later. The impedance measuring unit 13 detects the resistance value or 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. Moreover, the measurement timing of the impedance in the impedance measurement unit 13 is controlled by the calculation unit 17.

  The storage unit 14 is a part that stores various data. The storage unit 14 stores an administration profile indicating an administration pattern for administering a drug solution, a control program for controlling the impedance measurement unit 13 and the like, threshold data used for liquid leakage detection, and the like. Furthermore, the storage unit 14 stores information received by the communication unit 15, impedance information measured by the impedance measurement unit 13, date / time information acquired by the date / time management unit 16, temperature information measured by the temperature measurement unit 18, and the like. Is done. Then, the storage unit 14 outputs a control program stored in advance, 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) that operates the insulin pump 1, an external portable information processing terminal, and a PC (personal computer) via a wired or wireless network. The communication unit 15 receives operation information operated by a user via a controller (not shown), a portable information processing terminal, and 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.

  Moreover, the communication part 15 is controlled by the calculating part 17, and outputs various information regarding the insulin pump 1 such as liquid leakage information and administration pattern to a controller (not shown), a portable information processing terminal, or the like.

  The date and time management unit 16 is a program part for performing date and time management, and may be mounted on a general microcomputer, and outputs date and 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 power even when the power is off.

  A program for controlling various devices such as the drive unit 12, the impedance measurement unit 13, the storage unit 14, the communication unit 15, the date and time management unit 16, the temperature measurement unit 18, and the motion detection unit 19 is installed in the calculation unit 17. . Then, the calculation unit 17 controls various operations of the insulin pump 1 based on the program. In addition, the calculation unit 17 receives information received by the communication unit 15 and 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.

  Furthermore, the calculation part 17 drives the drive part 12 based on the administration profile which shows the administration pattern of the chemical | medical solution memorize | stored in the memory | storage part 14. FIG. Thereby, the user is administered with a drug solution based on a predetermined administration profile. The arithmetic unit 17 includes, for example, a CPU (Central Processing Unit), a RAM (Random Access Memory), and a ROM (Read Only Memory) not shown here. The ROM may be the storage unit 14.

  The temperature measurement 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. Note that 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 the user wearing the insulin pump 1. When detecting the movement of the user, the movement detector 19 outputs the detection information to the calculator 17. Further, the motion detection unit 19 detects the orientation of the apparatus main body when the insulin pump 1 is mounted on the user. Then, the motion detection unit 19 outputs information regarding the detected orientation of the apparatus main body to the calculation unit 17.

FIG. 2 is an explanatory diagram illustrating the configuration of the pasting unit 20.
As shown in FIG. 2, the sticking unit 20 is provided with an administration unit 21 from which a hollow puncture needle that can puncture a user's skin is projected. Around the sticking part 20, an adhesive layer (not shown) for holding the sticking part 20 on the patient's skin is provided. 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. A first electrode 22 and a second electrode 23 showing an example of the liquid leakage detection unit are provided around the administration unit 21.

  The 1st electrode 22 and the 2nd electrode 23 are provided in the sticking surface affixed on the user's skin in the insulin pump 1. FIG. The first electrode 22 and the second electrode 23 are formed in a ring shape. The first electrode 22 is disposed so as to surround the administration unit 21. The second electrode 23 is disposed substantially concentrically with the first electrode 22 outside the first electrode 22 in the radial direction. The first electrode 22 and the second electrode 23 are connected to the impedance measuring unit 13. When liquid leakage occurs and a chemical solution such as insulin enters between the first electrode 22 and the second electrode 23, the impedance between the first electrode 22 and the second electrode 23 changes.

  In addition, although the example which formed the 1st electrode 22 and the 2nd electrode 23 in the ring shape and has arrange | positioned on the concentric circle of the administration part 21 was demonstrated in this example, it is not limited to this. For example, a plurality of first electrodes and second electrodes may be alternately arranged radially with respect to the administration unit 21, and the first electrode and the administration unit 21 are positioned between the first electrode and the second electrode. A second electrode may be arranged. Alternatively, a plurality of dotted 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 leak 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 leak detection, and FIG. 4 is an explanatory diagram showing an administration pattern in the first example of liquid leak detection. In the administration pattern shown in FIG. 4, the vertical axis represents the flow rate of the chemical solution passing through the administration unit 21, and the horizontal axis represents time.

  In the first example shown in FIG. 3 and FIG. 4, when continuous administration in which a certain amount of drug solution is continuously administered to a user over a day (24 hours), so-called basal administration, is performed. An example of performing bolus administration in which a predetermined amount of drug solution is administered before eating will be described. In bolus administration that shows an example of prescribed dose administration, the amount of drug solution to be administered increases compared to basal administration.

  First, the calculation unit 17 determines whether the current time is a bolus start setting time in a preset administration profile, or whether a bolus start command is received via the communication unit 15 (step S11). . In the process of step S <b> 11, when the calculation unit 17 determines that the current time is a bolus start set time or has received a bolus start command (YES determination in step S <b> 11), the calculation unit 17 controls the impedance measurement unit 13. Then, the first impedance is measured (step S12).

  Note that the arithmetic unit 17 continues the process of step S11 until the current time reaches the bolus start set time or until a bolus start command is received.

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

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

  Next, the calculation part 17 will control the drive of the drive part 12, and will return a dosage to basal administration, if predetermined time and predetermined amount bolus administration are completed. And the calculating part 17 controls the impedance measurement part 13, and measures the 2nd impedance (step S14).

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

  When the second impedance measurement by the impedance measurement 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. And the calculating part 17 judges whether the calculated difference value is larger than the threshold value previously stored in the memory | storage part 14 (step S15).

  Here, when liquid leakage occurs, the impedance between the first electrode 22 and the second electrode 23 decreases, and changes greatly 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 Via the external controller via the external controller. Then, the external controller outputs an alarm by vibration or sound to notify the user that a liquid leak has occurred (step S16). Thereby, the liquid leak detection process of the insulin pump 1 is completed.

  In addition, although the example which outputs a warning from an external controller was demonstrated, it is not limited to this, You may provide the output part which outputs a warning in the apparatus main body of the insulin pump 1. FIG. As an alarm, for example, vibration or sound may be performed alone, or a combination of vibration or sound may be generated.

  Moreover, in the process of step S15, when the calculating part 17 judges that the calculated difference value is smaller than a threshold value (NO determination of step S15), the calculating part 17 complete | finishes a liquid leak detection process. Thereby, the liquid leak detection process of the insulin pump 1 is completed.

  According to the liquid leak detection method in the first example, a change in impedance is detected before and after bolus administration, and the amount of change is compared with a threshold value to detect the liquid leak. 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-time impedance information, which is the impedance information before administration measured in the process of step S12, is larger than a preset threshold value. Thereby, before performing bolus administration, the abnormality around the administration unit 21 can be determined, and bolus administration can be performed normally. Note that 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 leak detection method will be described with reference to FIGS.
FIG. 5 is a flowchart showing a second example of the liquid leak detection, and FIG. 6 is an explanatory diagram showing an administration pattern in the second example of the liquid leak detection.

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

  First, the calculation unit 17 determines whether or not the current time is a bolus start setting time in a preset administration profile, or whether a 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 a bolus start command (YES determination in step S21), the calculation unit 17 drives the drive unit 12. Control and execute bolus administration (step S22). As a result, as shown in FIG. 6, bolus administration is performed, and the liquid feeding flow rate of the chemical 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 to return the dose to the basal administration. And the calculating part 17 controls the impedance measurement part 13, and measures the 1st impedance (step S23). In the process of step S23, when the impedance measurement unit 13 measures the first impedance, the impedance measurement unit 13 outputs the measured first impedance information (post-administration impedance information) T1 to the storage unit 14 and the calculation unit 17. To do.

  Next, the calculating part 17 judges whether the value of the 1st impedance information T1 which is impedance information after administration is smaller than the threshold value previously stored in the memory | storage part 14 (step S24). Here, when a liquid leak occurs, the impedance after administration between the first electrode 22 and the second electrode 23 decreases and changes more than a threshold value which is a 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 an external controller via the communication unit 15. An output of an alarm related to the generation is instructed (step S25). Thereby, the liquid leak detection process of the insulin pump 1 is completed.

  Moreover, in the process of step S24, when the calculating part 17 judges that the 1st impedance information T1 is larger than a threshold value (NO determination of step S24), the calculating part 17 complete | finishes a liquid leak detection process. Thereby, the liquid leak detection process of the insulin pump 1 is completed.

  According to the liquid leak detection method in the second example, the impedance is measured after the bolus administration, that is, after a predetermined amount of chemical solution is administered. Then, liquid leakage is detected based on the difference between the post-administration impedance information and the threshold value which is a reference value. In the liquid leakage detection method in the 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 measurement unit 13 is determined as a relative value as in the liquid leakage detection method in the first example. As a result, it is possible to prevent erroneous detection caused by the external environment and to improve the accuracy of liquid leak detection compared to conventional liquid leak detection methods that always measure impedance and determine liquid leak based on the absolute value of impedance information. Can be improved.

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

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

  First, the calculation unit 17 determines whether or not the current time is a bolus start setting time in a preset administration profile, or whether a bolus start command is 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 a bolus start command (YES determination in step S31), the calculation unit 17 drives the drive unit 12. Control and execute the bolus administration (step S32). As a result, as shown in FIG. 8, bolus administration is performed, and the liquid delivery flow rate of the drug solution that passes through the administration unit 21 is increased.

  Next, the calculating part 17 controls the temperature measurement part 18, and measures the temperature around the 1st electrode 22 and the 2nd electrode 23 (step S34). In the process of step S <b> 34, the temperature measurement 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 first impedance (step S35).

  Next, the calculating part 17 selects the threshold value used for liquid leak judgment from the several threshold value previously stored in the memory | storage part 14 based on the temperature measurement value by the temperature measurement part 18 (step S36). In addition, you may perform the selection process of the threshold value of step S36 before the impedance measurement process after administration of step S35. Further, the impedance measurement process after administration in step S35 may be performed before the temperature measurement process in step S34.

  Next, the calculating part 17 judges whether the value of the 1st impedance information T1 which is impedance information after administration is smaller than the threshold value selected by 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 an external controller via the communication unit 15. An output of an alarm related to the generation is instructed (step S38). Thereby, the liquid leak detection process of the insulin pump 1 is completed.

  Moreover, in the process of step S37, when the calculating part 17 judges that the 1st impedance information T1 is larger than a threshold value (NO determination of step S37), the calculating part 17 complete | finishes a liquid leak detection process. Thereby, the liquid leak 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 temperature around the first electrode 22 and the second electrode 23 which are detection units after bolus administration, that is, after a predetermined amount of drug solution is administered. Is set. Thereby, the amount of change in impedance caused by sweat can be taken into consideration, and the accuracy of liquid leak detection can be further improved.

  In the liquid leakage detection method according to the third example, as in the liquid leakage detection method according to the first example, the impedance is measured before bolus administration, and the pre-dose impedance information and the post-dose impedance information are measured. The difference may be calculated.

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

  In the fourth example shown in FIG. 9 and FIG. 10, a predetermined amount of chemical solution is used as a test so that the liquid leak can be detected whenever a liquid leak is suspected without being limited to holding a bolus before meal. An example in which is administered will be described. Therefore, the description of the steps common to the liquid leak detection method according to the first example is omitted.

  First, the calculation unit 17 determines whether or not the current time is a test start set time in a preset administration profile, or whether a 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 a test start command (YES determination in step S41), the calculation unit 17 controls the impedance measurement unit 13. Then, the first impedance is measured (step S42). When the impedance measuring unit 13 measures the first impedance, the impedance measuring unit 13 stores the measured first impedance information (pre-administration impedance information) T1 in the storage unit.

  When the first impedance measurement by the impedance measurement unit 13 is completed, the calculation unit 17 controls the drive of the drive unit 12 and performs test administration indicating an example of administration of a predetermined amount for a predetermined time. And the calculating part 17 will control the drive of the drive part 12, and will restart basal administration, when the test administration of predetermined time is completed (step S43). Thereby, as shown in FIG. 10, test administration is performed, and the liquid feeding flow rate of the drug solution passing through the administration unit 21 is temporarily increased. Moreover, the calculating part 17 memorize | stores the increase amount U1 of the chemical | medical solution increased at the time of test administration in the memory | storage part 14. FIG. The increase amount U1 may be stored in advance in the storage unit 14 before the test administration is executed.

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

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

  Next, the calculation unit 17 calculates a difference between the first impedance information T1 and the second impedance information T2, and determines whether the calculated difference value is larger than a threshold value stored in the storage unit 14 in advance. (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 passes through the communication unit 15. Instruct the external controller to output an alarm related to the occurrence of liquid leakage. Then, the external controller outputs an alarm by vibration or sound to notify the user that a liquid leak has occurred (step S46). When the alarm is output, the calculation unit 17 performs a process of step S47 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 of step S45), the calculation unit 17 controls the drive of the drive unit 12 to administer the compensation period. To implement. And the calculation part 17 will control the drive of the drive part 12, if implementation of compensation period administration is completed, and will restart basal administration (step S47). Thereby, when the test administration is performed, the liquid leakage detection process ends.

  Here, when the test administration is performed in the process of step S43, the dose of the drug solution is increased as compared with the normal basal administration. Then, it is necessary to reduce by the same amount as the increase amount U1 of the drug solution increased at the time of test administration, after the test administration is performed, than the dose at the time of basal administration. Therefore, in the compensation period administration in the process of step S47, the decrease 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. Thereby, even if the dosage of a chemical | medical solution increases temporarily other than bolus administration, it can prevent that the dosage of a chemical | medical solution of a day changes. In addition, since the amount of insulin that does not cause hypoglycemia due to test administration is selected as the increase amount U1 of the chemical solution, leakage detection can be performed with a smaller amount of chemical solution than the normal bolus dose. Therefore, by performing several test administrations with different increase amounts U1, the upper limit value of the dose causing liquid leakage can be examined, which can be used for setting the upper limit value of a predetermined amount in bolus administration.

  According to the liquid leakage detection method shown in the fourth example, even when the test administration is performed, the liquid leakage detection can be accurately performed in the same manner as 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 leak detection method will be described with reference to FIGS.
FIG. 11 is a flowchart showing a fifth example of liquid leak detection, and FIG. 12 is an explanatory diagram showing an administration pattern in the fifth example of liquid leak detection.

  The liquid leak detection method according to the fifth example shown in FIG. 11 uses the detection information from the motion detector 19 to detect leaks during exercise after bolus administration. Description of steps common to the liquid leakage detection method according to the first example is omitted.

  First, the calculation unit 17 determines whether or not the current time is a bolus start setting time in a preset administration profile, or whether a 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 a bolus start command (YES determination in step S51), the calculation unit 17 controls the impedance measurement unit 13. Then, the first impedance is measured (step S52).

  Next, the calculating part 17 controls the drive of the drive part 12, and performs bolus administration (step S53). And the calculating part 17 will control the impedance measurement part 13, and will measure the impedance of the 2nd time, if predetermined time and predetermined amount bolus administration are completed (step S54).

  Next, the calculation unit 17 calculates a difference between the first impedance information T1 and the second impedance information T2, and determines whether the calculated difference value is larger than a threshold value stored in the storage unit 14 in advance. (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 liquid leakage 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 or sound to notify the user that a liquid leak has occurred (step S56). Thereby, the liquid leakage detection process ends.

  Moreover, in the process of step S55, when the calculating part 17 judges that a difference value is smaller than a threshold value (NO determination of step S55), the calculating part 17 makes the exercise | movement detection part 19 exercise | movement during the exercise | movement detection period Q1. It is determined whether or not it has been detected (step S57). As shown in FIG. 12, the motion detection period Q1 is a predetermined time after the bolus administration. The motion detection period Q1 may be constant regardless of the dose in bolus administration, but the time may be adjusted based on the dose in bolus administration. For example, when the bolus dose is small, the motion detection period Q1 may be set short, and when the bolus dose is large, the motion detection period Q1 may be set long. 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 it is determined that there is motion when the integrated value exceeds a preset threshold value. May be.

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

  Further, in the process of step S57, when the movement detection unit 19 detects the movement of the user during the movement detection period Q1 (YES determination in step S57), the calculation unit 17 controls the impedance measurement unit 13 to perform the third time. Is measured (step S58).

  In the process of step S58, when the impedance measurement unit 13 measures the impedance for the third time, the impedance measurement 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 computing unit 17 calculates the difference between the first impedance information T1 and the third impedance information T3. And the calculating part 17 judges whether the calculated difference value is larger than the threshold value previously stored in the memory | storage part 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 medicinal solution leaks when the bolus is administered from the portion of the user's skin where the administration unit 21 punctures due to the user's exercise, the impedance between the first electrode 22 and the second electrode 23 changes. . And in the process of step 59, when the calculating part 17 judges that the calculated difference value of the 1st impedance information T1 and the 3rd impedance information T3 is larger than a threshold value (YES determination of step S59), the calculating part 17 Then, it is determined that liquid leakage has occurred, and an alarm is output (step S60). The alarm output at step S56 and the alarm output at step S60 may be the same sound or vibration, or may be different sounds or vibrations. Thereby, the liquid leakage detection process ends.

  Moreover, in the process of step S59, when the calculating part 17 judges that the calculated difference value is smaller than a threshold value (NO determination of step S59), the calculating part 17 does not generate | occur | produce the liquid leak at the time of an exercise | movement. to decide. Thereby, the liquid leakage detection process ends.

  According to the liquid leakage detection method in the fifth example, it is possible to determine the presence or absence of liquid leakage that occurs during exercise by detecting the user's movement after bolus administration, that is, after administration of a predetermined amount of drug solution. . In the above-described liquid leakage detection method in the fifth example, the example in which the liquid leakage during one movement in the movement detection period Q1 is determined has been described. However, the present invention is not limited to this. For example, during the movement detection period Q1, every time the movement detection unit 19 detects the movement of the user, the impedance may be measured to detect a liquid leak.

  Also, in the liquid leakage detection method in the fifth example, the temperature information measured by the temperature measurement unit 18 may be used as in the liquid leakage detection method according to the third example. That is, the threshold value used in the determination of the presence or absence of liquid leakage in the processing of step S55 and step S59 may be set based on the temperature information measured by the temperature measurement unit 18.

  The embodiment of the present invention has been described above including its 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 scope of the invention described in the claims.

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

  In addition, a threshold value used for determining a liquid leak may be set based on information on the orientation of the apparatus main body detected by the motion detection unit 19.

  DESCRIPTION OF SYMBOLS 1 ... Insulin pump (medical solution administration apparatus) 11 ... Power supply part 12 ... Drive part 13 ... Impedance measurement part 14 ... Memory | storage part 15 ... Communication part 16 ... Date management part 17 ... Calculation part 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 (6)

An administration unit for administering a drug solution to a user;
A drive unit for delivering the drug solution to the administration unit;
A detection unit provided around the administration unit;
An impedance measurement unit for measuring the impedance of the detection unit;
A calculation unit for controlling the drive unit and the impedance measurement unit;
A storage unit storing a threshold value for impedance information measured by the impedance measurement unit,
The computing unit is configured to leak the medicinal solution based on the post-administration impedance information measured by the impedance measuring unit and the threshold stored in the storage unit after the driving unit sends out a predetermined amount of medicinal solution to the administration unit. A drug administration device that determines the presence or absence of a drug The calculation unit acquires pre-administration impedance information measured by the impedance measurement unit before the driving unit sends out a predetermined amount of drug solution to the administration unit, and the post-administration impedance information, the pre-administration impedance information, and the The chemical solution administration device according to claim 1, wherein presence or absence of leakage of the chemical solution is determined based on a threshold value. A temperature measuring unit for measuring the temperature of the detecting unit;
The storage unit stores a plurality of threshold values set in advance based on temperature information,
The calculation unit obtains temperature information measured by the temperature measurement unit when the driving unit sends out a predetermined amount of drug solution to the administration unit, and stores a plurality of information stored in the storage unit based on the temperature information The medicinal-solution administration device according to claim 1 or 2, wherein a threshold used for determining the medicinal-solution leakage is selected from the threshold. A motion detector for detecting the motion of the user;
The calculation unit acquires the impedance information during exercise measured by the impedance measurement unit when the motion detection unit detects the user's movement, and stores the impedance information during exercise and the threshold value stored in the storage unit The medical solution administration device according to any one of claims 1 to 3, wherein the presence or absence of leakage of the chemical solution is determined based on the above. The chemical solution administration device according to claim 4, wherein the movement of the user is detected by the movement detection unit during a predetermined period after a predetermined amount of the chemical is administered to the user. The arithmetic unit controls the driving unit to continuously administer a predetermined amount of medicinal solution to the user, and to administer a predetermined amount of administrating a predetermined amount of medicinal solution that is higher than the continuous administration to the user. The chemical solution administration device according to any one of claims 1 to 5, wherein after performing the predetermined amount administration, the amount of the chemical solution in the continuous administration is decreased by an amount increased by the predetermined amount administration.

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