JP2013257339A - Biochemical measuring instrument using biosensor cartridge preventing reuse of biosensor cartridge - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a biochemical measuring instrument using a biosensor cartridge which prevents reuse of the biosensor cartridge that must not be used.SOLUTION: A urine sugar meter is constituted so that a biosensor cartridge 11 comprising a biosensor is connected to a urine sugar meter body 21 freely detachably. In the urine sugar meter, the biosensor cartridge 11 comprises a fuse 100 built therein, and the urine sugar meter body 21 comprises a detection and fusing circuit 106 for detecting and fusing the fuse 100. When the biosensor cartridge 11 is connected to the urine sugar meter 21 and used, the detection and fusing circuit 106 detects a conduction state of the fuse, to confirm that the new biosensor cartridge 11 is mounted and, when a non-conduction state of the fuse is detected, the used biosensor cartridge 11 is determined as being mounted and displays "replacement of the biosensor cartridge" on a display device 29 of the urine sugar meter body 21.

Description

  The present invention relates to a biochemical measuring instrument such as a urine sugar meter using a biosensor, and more specifically, a biochemical measuring instrument using a biosensor cartridge that prevents reuse of the biosensor cartridge. It is about.

  In urine glucose meters and other biochemical measuring instruments that use biosensors, biosensors have variations in sensitivity that change or deteriorate over time, and the number of measurements since the start of use. Elapsed time has a lifetime. For this reason, a biosensor used for a urine sugar meter is not disposable, but has a certain life span set in advance with respect to the number of measurements and the elapsed time from the start of use. Therefore, in order to ensure the reliability of measurement, it is necessary to replace the biosensor when the preset number of measurements and elapsed time are exceeded. It should be noted that with respect to variations in sensitivity, it is necessary to calibrate at the stage of starting use and at certain time intervals or every certain number of times.

  Conventionally, some digital urine sugar meters for home use have taken the following measures for the life of the biosensor. The main unit of the urine sugar meter is equipped with a nonvolatile memory, a clock for measuring time, and a display device. The time when the biosensor cartridge is mounted on the main unit is recorded, and the biosensor cartridge is installed by the clock function in the main unit. The elapsed time is measured from the wearing time. After a certain period of time corresponding to the life of the biosensor has passed, a warning for replacing the biosensor cartridge is displayed on the display device of the main body of the urine sugar meter. Urged to. In addition, if the number of measurements is stored in the memory and exceeds a certain number of times, a warning for replacing the biosensor cartridge is similarly displayed on the display device, and the measurement can no longer be performed and replaced with a new biosensor. I was urged to do.

  Japanese Patent No. 2541081 discloses a biosensor that is immersed in collected blood and measures a blood glucose level from a change in current value due to an enzymatic reaction of sugar. In this example, the biosensor itself manages the biosensor data (for example, the date of manufacture of the biosensor, the lot number, the storage expiration date of the biosensor, the contents stored at the time of manufacture of the biosensor characteristics, etc.) and the measurement result (Furthermore, it is equipped with a memory that records the measurement date and time, continuous use time, etc.), for example, the total of the measurement time is collated with the management data in the data storage memory, so Configured to inform.

Japanese Patent No. 2541081

  However, in the conventional biochemical measuring instrument such as the digital urine sugar meter described above, even after the biosensor lifetime has passed, once the biosensor is removed and attached, the main unit already has the lifetime usage time or the lifetime usage count. However, since it is impossible to determine whether the biosensor is a used biosensor that has passed, or a new biosensor that has not been used, the biosensor is recognized as a new biosensor and can be used continuously. Since the performance of a biosensor gradually deteriorates during use, the use of a biosensor that has passed the lifetime use time or the lifetime use count is not only a problem in performance but also the measurement result is unreliable. However, even if a user accidentally removes a used biosensor and reattaches it, the surface was operating normally.

  In addition, the biosensor disclosed in the above-mentioned Japanese Patent No. 2541081 has a built-in memory, and is past the expiration date from the date of manufacture of the biosensor and the storage expiration date of the biosensor. I can let you know. However, it is effective when the storage expiration date has passed without being used, but cannot be used when the number of measurements and the elapsed time from the start of use have a lifetime.

On the other hand, the biosensor disclosed in Japanese Patent No. 2541081 is for processing a large amount of sample blood in a measurement specialized institution, and can be understood as a biosensor portion of a large biochemical measuring instrument. Therefore, no consideration is given to a home biochemical measuring instrument such as a home urine sugar meter.
Also, in some types of biosensors, if abnormal temperatures last for a long time, the performance of the biosensor may deteriorate and become unusable, but no countermeasure has been taken.

  In addition, certain biosensors need to be immersed in a preservation solution during storage, and if left out of the preservation solution and left to stand, the biosensor dries, causing serious damage to the biosensor. There is a possibility that performance may not be satisfied. However, conventionally, no countermeasure has been taken.

  In addition, if the measured value in the state of being immersed in the storage solution shows an abnormal value, the biosensor is likely to be faulty, but only displays an error when the abnormal value is shown. When it returned to the normal value, it was possible to measure despite the high possibility of failure. For this reason, the user does not know that there is a problem with the reliability of the measurement result, and there is a fear that the user may trust the measurement result and take a wrong measure.

  Therefore, the present invention is intended to provide a biochemical measuring instrument using a biosensor cartridge that can prevent reuse of an unusable biosensor cartridge.

  According to the present invention, in the biochemical measuring instrument using the biosensor cartridge, the biosensor cartridge including the biosensor is configured to be detachably connected to the biochemical measuring instrument main body. The biochemical cartridge has a built-in used instruction means for instructing that the biosensor cartridge has been used, and the biochemical measuring instrument body has a writing means for writing used information in the used instruction means, The control means of the biochemical measuring device main body is configured such that when the biosensor cartridge that has not been used by the used instruction means is connected to the biochemical measuring instrument main body, the used instruction is given by the writing means. The biosensor cartridge in which used means is written while the used indicating means indicates used. Is connected to the biochemical measuring device main body, the biochemical measuring device main body control means confirms the used instruction means of the biosensor cartridge and displays it on the display device of the biochemical measuring device main body. A biochemical measuring device is provided that is configured to display "Replace Biosensor Cartridge" and prevent measurement using a used biosensor cartridge. Is done.

  In an embodiment of the present invention, the control means of the biochemical measuring device main body is used as the used indicating means by the writing means when a new biosensor cartridge is connected to the biochemical measuring device main body. Can be written.

  In this embodiment, in one embodiment of the present invention, the used instruction means is a fuse, the writing means is a fuse blowing means, and the biosensor is in a state where the fuse is blown. Indicates that the cartridge has been used.

  The fuse can be provided independently of the connector connection detection circuit of the biosensor cartridge, or can also serve as the connector connection detection circuit of the biosensor cartridge.

  In another embodiment of the present invention, the used instruction means is a non-volatile memory, and a state in which “used” is written in the non-volatile memory indicates that the biosensor cartridge has been used. Instruct.

  In still another embodiment of the present invention, when the control means of the biochemical measuring device main body writes the used information in the used indicating means by the writing means, When the biosensor cartridge biochemical measuring instrument main body that has been used is written in the storage means with the identification number and management information of the biosensor cartridge, even if the used instruction means indicates that it has been used. The identification number of the attached biosensor cartridge matches the identification number of the biosensor cartridge stored in the storage means in the biochemical measuring device body, and the storage means in the biochemical measuring device body When it is determined from the stored management information that the biosensor cartridge has not reached the service life, the biochemical measuring instrument book The display device does not display the "exchange of the biosensor cartridge" It is also possible.

  In still another embodiment of the present invention, the used indicating means is a biosensor of the biosensor cartridge, the writing means is an overcurrent supply means, and the biosensor is the overcurrent. The state destroyed by the supply means indicates that the biosensor cartridge has been used.

  In another aspect of the present invention, the control means of the biochemical measuring device main body considers that the biosensor cartridge is used when the attached biosensor cartridge reaches the end of its service life, and The biosensor is destroyed by the overcurrent supply means.

  In a preferred embodiment of the present invention, the biochemical measuring device is a urine sugar meter.

  Furthermore, according to the present invention, a biochemical measuring instrument using a biosensor cartridge is configured such that a biosensor cartridge including a biosensor is detachably connected. The biosensor cartridge includes the biosensor cartridge. Is connected to the biochemical measuring instrument, has nonvolatile storage means that can be read from and written to the biochemical measuring instrument, and the biosensor cartridge is connected to the biochemical measuring instrument The biochemical measuring device accesses the non-volatile storage means, reads information for determining whether the biosensor cartridge is usable, and if the biosensor cartridge is not usable, "Replace biosensor cartridge" on the display device of biochemical measuring instrument Characterized in that it is configured to display, biochemical measuring instrument that uses a biosensor cartridge is provided.

  In one aspect of the present invention, the biochemical meter writes information that can determine an elapsed time from the start of use in the nonvolatile storage means, and increments the stored number of uses for each measurement. At least when the biochemical measuring instrument is turned on, the nonvolatile storage means is accessed, and the information relating to the biosensor cartridge and the number of times used can be determined from the start of use. When the elapsed time or the number of times of use since reading and use has reached the upper limit, “replace biosensor cartridge” is displayed on the display device of the biochemical measuring device.

  In another aspect of the present invention, the biochemical meter writes an error state in the non-volatile storage means and accesses the non-volatile storage means at least when the biochemical meter is powered on. When the error information related to the biosensor cartridge is read out and the read error information means that the biosensor cartridge is unusable, the “replacement of the biosensor cartridge” is displayed on the display device of the biochemical measuring instrument. Is displayed.

  In yet another aspect of the present invention, the biosensor cartridge has temperature detection means, and the biochemical measuring instrument measures the temperature of the biosensor by the temperature detection means, and the temperature measurement value is: When the temperature is lower than the lower limit temperature, the low temperature counter set in the non-volatile storage means is incremented. When the temperature measurement value is higher than the upper limit temperature, the high temperature set in the non-volatile storage means is set. The counter is incremented, and when the low temperature counter or the high temperature counter reaches a predetermined value, “replace biosensor cartridge” is displayed on the display device of the biochemical measuring device.

  In the above aspect, preferably, the biochemical measuring device has means for detecting whether or not the biosensor of the biosensor cartridge is immersed in a storage solution, and the biosensor is immersed in the storage solution. The temperature of the biosensor is measured by the temperature detecting means after a predetermined time has elapsed since the detection of the detection.

  In still another aspect of the present invention, the biochemical measuring device has means for detecting whether or not the biosensor of the biosensor cartridge is immersed in a preservation solution, and the biosensor When it is detected that is not immersed in the storage solution, error information is written in the non-volatile storage means, and “replacement of biosensor cartridge” is displayed on the display device of the biochemical meter.

  In yet another aspect of the present invention, the biochemical meter applies a voltage to the biosensor of the biosensor cartridge in a state where the biosensor of the biosensor cartridge is immersed in a storage solution. When a current value is measured and the measured current value indicates an abnormality, error information is written in the non-volatile storage means, and “replace biosensor cartridge” is displayed on the display device of the biochemical measuring device. .

  In still another aspect of the present invention, the biochemical measuring device writes, in the nonvolatile storage means, an accumulated time in a state where the biosensor of the biosensor cartridge is immersed in a storage solution, When the biochemical measuring instrument is turned on, the non-volatile storage means is accessed to read out the accumulated time when immersed, and when the accumulated time exceeds a predetermined time, “Replace biosensor cartridge” is displayed on the display device of the chemical measuring instrument.

  In yet another aspect of the present invention, the biochemical meter writes a calibration coefficient for the biosensor, an elapsed time at the time of calibration, and the number of calibration measurements in the nonvolatile storage means.

  In the various aspects of the present invention described above, preferably, the non-volatile storage means is a non-volatile memory provided in the biosensor cartridge.

  According to the present invention described above, when a biosensor cartridge that has been used even once is mounted, the used instruction means indicates that “the biosensor cartridge has been used”. Replacement is instructed that the cartridge is not new. In this case, preferably, the biochemical measuring instrument is disabled. Thus, a used biosensor cartridge will never be reused accidentally.

  According to the above-described present invention, the sensor is temporarily provided by providing a non-volatile memory for storing the elapsed time and the number of measurements since the sensor is mounted on the biosensor cartridge (for example, the biosensor substrate accommodated therein). Even if the sensor is removed or attached, it can be determined whether the sensor has already expired, and misuse (unauthorized use) can be prevented.

  If the sensor has been exposed to abnormal temperature for a long time, if the sensor is left in a state where it is not stored in the preservation liquid bottle, if the sensor is immersed in the preservation liquid and the measured value is abnormal, Even if the sensor is once removed and attached, it is determined whether or not the possibility that the performance of the sensor has deteriorated is large, and misuse (unauthorized use) can be prevented.

It is an external view which decomposes | disassembles and shows the urine sugar meter to which this invention is applied. It is an external view which shows the storage state of the urine sugar meter to which this invention is applied. It is a block diagram which shows the electronic structure of Example 1 of the urine sugar meter which can implement this invention. It is a figure which shows the display form of the display part in FIG. 3 is a circuit diagram of a fuse circuit that can be used to implement the first embodiment. It is a flowchart which shows the procedure about operation | movement of Example 1 of this invention. It is a block diagram which shows the electronic structure of Example 2 of the urine sugar meter which can implement this invention. It is a flowchart which shows the procedure about the operation | movement of Example 2 of this invention. It is a block diagram which shows the electronic structure of Example 3 of the urine sugar meter which can implement this invention. It is a flowchart which shows the procedure about the operation | movement of Example 3 of this invention. It is a block diagram which shows the electronic structure of Example 4 of the urine sugar meter which can implement this invention. It is a flowchart which shows the procedure about the operation | movement of Example 4 of this invention. It is a flowchart which shows the procedure about the operation | movement of Example 5 of this invention. It is a flowchart which shows the procedure about operation | movement of Example 6 of this invention. It is a flowchart which shows the procedure about operation | movement of Example 7 of this invention. It is a block diagram which shows the electronic structure of Example 8 of the urine sugar meter which can implement this invention. It is a flowchart which shows the procedure about the operation | movement of Example 8 of this invention.

Hereinafter, the present invention will be described by taking a home digital urine sugar meter as an example of a biochemical measuring instrument to which the present invention is applied. Digital urine glucose meters that can be used in general households are already on the market, and various digital urine glucose meters have already been proposed in many patent applications. In the home digital urine sugar meter to which the present invention is applied, the heart part related to urine sugar measurement is conventionally known, for example, disclosed in the following patent documents and others of the applicant of the present invention. The detailed description related to urinary sugar measurement is omitted here.
JP 2006-047125 A JP 2006-153849 A

Example 1
1 and 2 are external views of a urine sugar meter for carrying out the present invention, FIG. 3 is a block diagram showing an electrical configuration, and FIG. 4 is a partially enlarged view showing a display form of a display unit. .
As shown in FIG. 1, the urine sugar meter 1 shown in FIG. 1 measures and displays a urinary sugar concentration based on a biosensor cartridge 11 that electrochemically detects urinary sugar, and detection by the biosensor cartridge 11. The urine sugar meter main body 21 is a part that holds the urine sugar meter during measurement. The biosensor cartridge 11 and the urine sugar meter body 21 can be separated from each other as shown in FIG. 1 and can be connected to each other as shown in FIG. 2 so that the biosensor cartridge 11 can be replaced. The illustrated urine sugar meter 1 can be stored by inserting the biosensor cartridge 11 into a stand 41 having a magnet 42 as shown in FIG. 2 when not in use. The stand 41 contains a bottle containing a preservation solution. When the urine sugar meter 1 is correctly inserted into the stand 41, the urine sugar biosensor 13 and the thermistor 14 (to be described later) of the biosensor cartridge 11 are inserted. The tip portion (including at least) is configured to be immersed in the storage solution in the built-in bottle.

  As shown in the block diagram of FIG. 3, the biosensor cartridge 11 contains the urine sugar biosensor 13, the thermistor 14, the stand detection reed switch 15, the connector 16 and the connector connection detection circuit 17 in the housing 12 shown in FIG. Furthermore, the fuse 100 is accommodated in the housing 12 according to the present invention. The urine sugar meter body 21 includes a power source 23, operation buttons 24 (24a, 24b), a D / A conversion device 25, a biosensor drive circuit 26, an A / D conversion device 27, a buzzer 28, an LCD display device 29, an external device. The input / output interface terminal 30, the connector 31, and the microcomputer 32 are accommodated in the housing 22 shown in FIG. Furthermore, according to the present invention, a fuse detection and fusing circuit 106 is further provided.

  The urine sugar biosensor 13 has a lifetime, and when the usage limit is reached, the LCD display device 29 displays that the biosensor is to be replaced. In that case, the user removes the biosensor cartridge 11 from the urine sugar meter main body 21 and attaches a new biosensor cartridge 11 to the urine sugar meter main body 21. Since the biosensor cartridge 11 and the urine sugar meter main body 21 are electrically connected, it is preferable that the connector 16 of the biosensor cartridge 11 can be easily connected to the connector 31 of the urine sugar meter main body 21 at the time of replacement. Moreover, since urine and washing water are poured on the biosensor cartridge 11, the space between the biosensor cartridge 11 and the urine sugar meter body 21 must be excellent in waterproofness. No matter how many times it is exchanged, it must always be maintained.

  Further, when the battery built in the urine sugar meter main body 21 has reached the end of its life, it is necessary to replace it with a new battery. However, it is desirable to consider that the battery can be easily replaced by the user. That is, it is preferable that the battery can be easily taken out from the urine sugar meter main body 21 and a new battery can be easily attached to the urine sugar meter main body 21.

  The urine sugar biosensor 13 detects the urinary sugar concentration over a wide range of low, medium and high levels while excluding the influence of contaminants in the urine. The urine sugar biosensor 13 is an enzyme configured as a biosensor for detecting urine components. The thermistor 14 detects the temperature of urine at the time of measurement, and corrects the temperature characteristics of the urine sugar biosensor 13.

  When the urine sugar meter 1 is stored in the stand 41, the stand detection reed switch 15 is turned off (or on), for example, due to the influence of the magnetic field by the magnet 42, and the stand detection reed switch 15 is turned off (or on). The microcomputer 32 takes power-saving measures such as turning off the LCD display device 29 and greatly reducing the clock frequency so as to minimize power consumption. The functions necessary for realizing the functions of the present invention are maintained. When the urine sugar meter 1 is taken out from the stand 41, the stand detection reed switch 15 is removed from the influence of the magnetic field by the magnet 42 and is turned on (or off), and the stand detection reed switch 15 is turned on (or off). The microcomputer 32 recovers all the functions of the urine sugar meter and enables mode setting, calibration, measurement of the urine sugar concentration, and the like.

  The power source 23 is a battery and supplies power to each part of the electrical system of the urine sugar meter 1. The operation buttons 24 (24a, 24b) are used to detect that the button has been pressed, select a mode and meal content, register settings, and calibrate. The D / A converter 25 converts the digital signal (drive signal) from the microcomputer 32 into an analog signal (drive signal) and outputs the analog signal (drive signal). The biosensor drive circuit 26 supplies a drive signal to the urine sugar biosensor 13 based on the drive signal from the D / A converter 25 and receives the detection signal detected by the urine sugar biosensor 13 to receive an A / Output to the D converter 27.

  The A / D converter 27 converts an analog signal (detection signal) from the biosensor drive circuit 26 into a digital signal (detection signal) and outputs the digital signal. Based on the signal from the microcomputer 32, the buzzer 28 generates a buzzer sound for notifying that urine sugar measurement is performed, for example. Based on the signal from the microcomputer 32, the LCD display device 29 displays a calibration status, a measurement status, a biosensor replacement notification, a battery replacement notification, a urine sugar measurement result notification, and a determination result notification.

  More specifically, the status of calibration is displayed by lighting the “reference alignment” and the “water drop mark” on the display contents shown in FIG. 4 during calibration. Moreover, the status of measurement is displayed by lighting any of “Preparing”, “Measurement”, “Washing” or “End” during the measurement process. Furthermore, the notification of replacement of the biosensor cartridge 11 is displayed by turning on “sensor replacement” at the time of replacement of the urine sugar biosensor 13. Further, a battery replacement notice is displayed by turning on the “battery mark” at the time of replacement. Furthermore, the “4-digit number” illustrated as “1347” in the center lights the urine sugar change value, the reference urine sugar change value, or the normal urine sugar change value after each measurement, thereby indicating the urine sugar measurement result. Display an announcement. Further, among the three “triangular marks”, the position corresponding to the determination content printed on the housing 22 is turned on after each determination to display the status of the selection mode.

  The external input / output interface terminal 30 is used to connect the external input / output interface 38 in the microcomputer 32 to an external device (not shown) such as a personal computer. Various data are transmitted between the microcomputer 32 and the external device. This is for communicating (input data from an external device and output data such as urine sugar measurement results and determination results from the urine sugar meter 1). When the connectors 16 and 31 are connected, the urine sugar biosensor 13 is connected to the sensor drive circuit 26, the fuse 100 is connected to the fuse detection and fusing circuit 106, the thermistor 14, the stand detection reed switch 15, and the connector. The connection detection circuit 17 is connected to each corresponding port of the microcomputer 32, and the biosensor cartridge 11 and the urine sugar meter main body 21 are electrically connected. The connector connection detection circuit 17 detects whether the connector 16 and the connector 31 are connected.

  Similar to the above-mentioned Patent Document 3, the microcomputer 32 calculates various urine sugar values, various availability determinations, etc., and controls and controls various devices 33, a ROM 34 that stores control and calculation programs, and the like. Results: RAM 35 for temporarily storing externally read programs, clock 36 for timing various notifications, selected mode, meal content, various calculated urine sugar values, determined determination results, etc. Auxiliary storage device 37, an external input / output device that communicates various data (input data from external devices and output data such as urine sugar measurement results / judgment results from urine sugar meter 1) with external devices such as personal computers Interface 38, ports connected to each part of the electrical system (not shown), etc., urine sugar value immediately before meal, urine sugar value after meal, reference urine sugar value, reference meal Notification that urine sugar value, normal pre-meal urine sugar value, normal post-meal urine sugar value should be measured, pre-meal urine sugar value, immediately before meal urine sugar value, post-meal urine sugar value, reference pre-meal urine sugar value, immediately before meal urine sugar value・ Standard postprandial urinary glucose level ・ Normal pre-meal urinary glucose level ・ Normal postprandial urinary glucose level ・ Measurement of normal postprandial urinary glucose level, urinary glucose change value (difference between postprandial urinary glucose level and premeal urinary glucose level) ・ Reference urine Sugar change value (difference between urine sugar value after reference meal and urine sugar value immediately before reference meal), normal urine sugar change value (difference between urine sugar value after normal meal and urine sugar immediately before normal meal), and difference urine sugar change value between meals (Difference between normal urine sugar change value and reference urine sugar change value), whether the amount of sugar in the body can be changed based on the urine sugar change value, Processing such as control regarding the determination of availability and the output of these computations and determination results is performed.

  As described above, according to the present invention, the fuse 100 and the fuse detection and fusing circuit 106 are provided. FIG. 5 illustrates an example of connection between such a fuse and a fuse detection and fusing circuit. One end 104 of the fuse 100 is connected to a high voltage side (for example, +3.3 V) of the power source 23 via a high resistance (for example, 3.3 MΩ) 102, and the other end of the fuse 100 is grounded. In this fuse circuit, only the fuse 100 is provided on the biosensor cartridge 11 side, and the other circuits are provided on the urine sugar meter main body 21 side. In FIG. 3, the circuit portion other than the high resistance 102 is omitted. Therefore, one end 104 of the fuse 100 is connected to one end of the high resistance 102 via the connectors 16 and 31, and one end 104 of the fuse 100, that is, a connection point between the fuse 100 and the high resistance 102 is also provided on the main body 21 side. And connected to a fuse detection and fusing circuit 106 controlled by the microcomputer 32. The fuse 100 has a sufficiently low resistance value compared to the resistance value of the high resistance 102 and is made of a material or a structure that can be blown at a high voltage side voltage such as + 3.3V.

  Therefore, when the fuse is not blown, the potential at the connection point (104) between the fuse 100 and the high resistance 102 is the ground potential. Therefore, when the biosensor cartridge 11 is mounted on the main body 21, if the microcomputer 32 detects that the potential of the connection point (104) is the ground potential via the fuse detection and fusing circuit 106, the microcomputer 32 11 can be determined to be new. When a new biosensor cartridge 11 is mounted, the microcomputer 32 applies +3.3 V to the connection point (104) via the detection and fusing circuit 106 to blow the fuse. In a state where the fuse is blown, the potential at the connection point (104) between the fuse 100 and the high resistance 102 is the high voltage side (for example, + 3.3V) potential. Therefore, when the biosensor cartridge 11 in which such a fuse is blown is attached to the main body 21, it is detected via the detection and fusing circuit 106 that the potential at the connection point 104 is the high voltage side (for example, + 3.3V) potential. If detected, the microcomputer 32 can determine that the biosensor cartridge 11 has been used.

  Hereinafter, the operation of the first embodiment of the present invention will be described. The method for measuring the urine sugar value itself and the method for obtaining the various values described above are described in detail in Patent Document 3 described above. Is omitted here and the description is omitted.

  The present invention prevents a used biosensor cartridge from being used in a home digital urine sugar meter, and will be described below with reference to the flowchart of FIG. Note that the fuse 100 of the unused biosensor cartridge 11 is not blown and is in a conductive state. On the other hand, the fuse 100 of the used biosensor cartridge 11 is blown and is in a non-conductive state.

When a new biosensor cartridge 11 is attached to the urine sugar meter body 21 before or after the urine sugar meter body 21 is turned on When the urine sugar meter body 21 is turned on, the biosensor cartridge is attached to the urine sugar meter body 21 It is determined whether 11 is attached. This is determined by whether or not the connector connection detection circuit 17 can detect. If the connector connection detection circuit 17 cannot be detected, this process is repeated.

  On the other hand, when the biosensor cartridge 11 is mounted or when the biosensor cartridge 11 is mounted, the microcomputer 32 checks whether the fuse 100 is in a conductive state via the detection and fusing circuit 106. In the case of the circuit of FIG. 5, when the fuse detection / blown circuit 106 detects that the potential at the connection point (104) is the ground potential, the microcomputer 32 determines that the fuse 100 is in a conductive state. On the other hand, if the microcomputer 32 detects that the potential at the connection point (104) between the fuse 100 and the high resistance 102 is the high voltage side (for example, + 3.3V) potential via the fuse detection and fusing circuit 106, the microcomputer 32 The fuse 100 is determined to be in a non-conduction state (disconnection state).

  When the fuse 100 is in a conductive state, it means that the attached biosensor cartridge 11 is new (unused), and the microcomputer 32 proceeds to the next step through the fuse detection and fusing circuit 106. The fuse 100 is blown out. In the case of the circuit of FIG. 5, +3.3 V is applied to the connection point (104) via the detection and fusing circuit 106 to blow the fuse 100.

  On the other hand, the microcomputer writes the management information of the biosensor cartridge other than the start date of use into the auxiliary storage device 37, and further sets a measurement number counter in the auxiliary storage device 37, and sets “the number of use times zero”. deep.

  Next, the use start date / time is compared with the current date / time to determine the number of days that have elapsed since the start of use, and is compared with the lifetime use time (for example, 60 days). In this case, since the biosensor cartridge 11 is a new product, it is a matter of course that the service life has not been reached. Therefore, the process proceeds to the next step to determine whether the measurement has been performed. When the measurement is performed, the measurement number counter of the auxiliary storage device 37 is incremented by one.

  When the measurement is not performed and after the measurement number counter of the auxiliary storage device 37 is incremented by 1, the use number recorded in the measurement number counter of the auxiliary storage device 37 is set to the use limit number, that is, the life use number (200 times). ). In this case, since the biosensor cartridge 11 is a new article, since the number of times of use of the life has not been reached, the process returns to the step of determining whether or not the life use time has been reached. Unless the power is turned off, the three steps of “has the service life reached?”, “Has it measured” and “has the service life reached?” Are repeated.

  As described above, when the urine sugar meter 1 is housed in the stand 41, the stand detection reed switch 15 is turned off, for example, by the influence of the magnetic field by the magnet 42, and the microcomputer 32 is connected to the stand detection reed switch. It detects that the urine sugar meter 1 is housed in the stand 41 by detecting 15 off states (or on states). The microcomputer 32 takes power saving measures such as turning off the LCD display device 29 so as to reduce power consumption as much as possible and greatly reducing the clock frequency. However, the microcomputer 32 is not placed in a complete sleep state. The clocking function using a clock with a significantly reduced frequency is maintained, and the three functions of "has the service life reached", "has it measured", and "has the service life reached?" Repeat steps.

  When the biosensor cartridge 11 has reached the lifetime usage time or the lifetime usage count, the process displays an “instruction to remove the sensor”, that is, “sensor replacement” on the display device, while making the urine sugar meter unable to measure.

  After issuing an instruction to remove the sensor, the operation of determining whether the sensor is attached is repeated. When the biosensor cartridge 11 is removed, the “instruction to remove the sensor” is erased, and the operation returns to the “determination operation as to whether the sensor is attached” immediately after the power is turned on.

  Therefore, when the lifetime has been reached while the urine sugar meter 1 is stored in the stand 41, when the urine sugar meter 1 is pulled out from the stand 41, the stand detection reed switch 15 detects it. The microcomputer restores all the functions and displays the “instruction to remove the sensor”, that is, the “sensor replacement” on the display device, while making the urine sugar meter impossible to measure.

When the biosensor cartridge 11 that has been used once is attached to the urine sugar meter main body 21 before or after turning on the power of the urine sugar meter main body 21 When the power of the urine sugar meter main body 21 is turned on, the urine sugar meter main body 21 It is determined whether or not the biosensor cartridge 11 is mounted.
When the biosensor cartridge 11 is attached or when the biosensor cartridge 11 is attached, the microcomputer 32 checks whether the fuse 100 is in a conductive state via the detection and fusing circuit 106.

  When the biosensor cartridge 11 that has been used once is mounted, since the fuse has already been blown, the microcomputer 32 indicates that the fuse 100 is in a non-conductive state (disconnected state). Judge that it is not new.

  Next, the microcomputer displays an “instruction to remove the sensor”, that is, “sensor replacement” on the display device, while making the urine sugar meter incapable of measurement.

  After issuing an instruction to remove the sensor, the operation of determining whether the sensor is attached is repeated. When the biosensor cartridge 11 is removed, the “instruction to remove the sensor” is erased, and the operation returns to the “determination operation as to whether the sensor is attached” immediately after the power is turned on.

  As described above, when the biosensor cartridge 11 that has been used even once is mounted, the fuse is blown, so that the biosensor cartridge 11 is not new and an exchange is instructed. Is made unmeasurable. Thus, a used biosensor cartridge will never be reused accidentally.

  Furthermore, after the new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and the urine sugar meter main body 21 is turned off once using the urine sugar meter, the urine sugar meter main body is used to use the urine sugar meter. When the power supply of 21 is turned on, it is not possible to measure the period during which the power of the urine sugar meter main body 21 is turned off, so it is not known whether the service life has passed. In this embodiment, the fuse is blown out. Assuming that the biosensor cartridge 11 is not new, replacement is instructed, and the urine sugar meter is disabled. Therefore, it is possible to prevent the biosensor cartridge in use that is not known whether the lifetime use time has elapsed from being reused.

Example 2
In the circuit of the first embodiment shown in FIG. 3, it is possible to provide a fuse in the connector connection detection circuit 17 instead of providing the independent fuse 100.

  FIG. 7 is a circuit diagram of the second embodiment in which a fuse is provided in the connector connection detection circuit 17, and only the portion of the second embodiment that is different from the first embodiment will be described. The fuse circuit shown in FIG. 5 can itself be used as the connector connection detection circuit 17. That is, the connector connection detection circuit 17 is constituted by the fuse 100. On the other hand, the connector connection detection circuit 17 constituted by the fuse 100 is connected to a fuse detection and fusing circuit 106 controlled by a microcomputer. Other configurations are the same as those of the first embodiment, and thus the description thereof is omitted.

  FIG. 8 is a flowchart illustrating the operation of the second embodiment of the present invention shown in FIG. Only the operation of the second embodiment which is different from the first embodiment will be described.

  When the power of the urine sugar meter main body 21 is turned on, it is determined whether or not a new biosensor cartridge 11 is attached to the urine sugar meter main body 21. This is determined by whether or not the connector connection detection circuit 17, that is, the fuse 100 can be detected. This process is repeated.

  When the connector connection detection circuit 17 is composed of the fuse 100 as in the circuit of FIG. 5, when it is detected via the fuse detection and fusing circuit 106 that the potential at the connection point (104) is the ground potential, The computer 32 determines that the fuse 100 is in a conductive state. If the fuse 100 is in a conducting state, it means that a new biosensor cartridge 11 is installed, and the process proceeds to the next step.

  On the other hand, if the microcomputer 32 detects that the potential at the connection point (104) between the fuse 100 and the high resistance 102 is the high voltage side (for example, + 3.3V) potential via the fuse detection and fusing circuit 106, the microcomputer 32 The fuse 100 is in a non-conducting state (disconnected state), that is, it is determined that “the biosensor cartridge 11 is not new”, and “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed. Make the meter unmeasurable. Since other operations are the same as those in the first embodiment, the description thereof is omitted.

  Also in the case of the second embodiment, when the used biosensor cartridge 11 is mounted, the fuse of the connector connection detection circuit 17 is blown, so that it is determined that the new biosensor cartridge 11 is not mounted. Then, the exchange is instructed and the urine sugar meter is made incapable of measurement. Thus, a used biosensor cartridge will never be reused accidentally.

  Furthermore, after the new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and the urine sugar meter main body 21 is turned off once using the urine sugar meter, the urine sugar meter main body is used to use the urine sugar meter. When the power supply of 21 is turned on, it is not possible to measure the period during which the power of the urine sugar meter main body 21 is turned off, so it is not known whether or not the service life has passed. In the case of the second embodiment as well, the connector connection detection circuit 17 However, since the fuse 100 is blown, it is instructed to replace the new biosensor cartridge 11 and the urine sugar meter is disabled. Therefore, it is possible to prevent the biosensor cartridge in use, which is known whether or not the lifetime use time has passed, from being reused. That is, the second embodiment achieves the same effect as the first embodiment.

Example 3
In the circuit of the first embodiment shown in FIG. 3, a nonvolatile memory can be provided in the biosensor cartridge 11 instead of the independent fuse 100.

  FIG. 9 is a circuit diagram of the third embodiment in which an EPROM 108 is provided as a nonvolatile memory in the biosensor cartridge 11 instead of the fuse 100. The reason why the EPROM is used is that it is not necessary to rewrite the contents written in the nonvolatile memory 108, as will be described later, and it is possible to use an erasable EEPROM or flash memory. Furthermore, the fuse detection and fusing circuit 106 of the first embodiment is not provided. Other configurations are the same as those of the first embodiment, and thus the description thereof is omitted.

  FIG. 10 is a flowchart illustrating the operation of the third embodiment of the present invention shown in FIG. Only the operation of the third embodiment which is different from the first embodiment will be described.

  When the power of the urine sugar meter main body 21 is turned on, it is determined whether or not a new biosensor cartridge 11 is attached to the urine sugar meter main body 21. This is determined by whether or not the connector connection detection circuit 17 can detect. If not detected, this process is repeated.

  On the other hand, when the biosensor cartridge 11 is mounted or when the biosensor cartridge 11 is mounted, the microcomputer 32 accesses the EPROM 108 and checks whether there is a writing in the EPROM 108. If there is no writing in the EPROM 108, the microcomputer 32 means that a new biosensor cartridge 11 is mounted, and the process proceeds to the next step.

  In the next step, instead of blowing the fuse, in Example 3, the microcomputer writes “used” to the EPROM 108.

  On the other hand, when there is a writing in the EPROM 108, the microcomputer 32 determines that “the biosensor cartridge 11 is not new” and displays “an instruction to remove the sensor”, that is, “sensor replacement” on the display device, while the urine sugar meter. Is disabled. Since other operations are the same as those in the first embodiment, the description thereof is omitted.

  It will be understood that the same effect as in the first embodiment can be achieved in the third embodiment.

Example 4
If the biosensor has passed its life, disabling the biosensor can prevent the use of a used biosensor that has passed its life. From this point of view, Example 4 makes the biosensor unusable when the biosensor has expired.

  FIG. 11 is a circuit diagram of the fourth embodiment. In the fourth embodiment, instead of the fuse 100 provided in the biosensor cartridge 11 of the first embodiment and the fuse detection and fusing circuit 106 provided in the urine sugar meter main body 21, a microcomputer 32 is used on the urine sugar meter main body 21 side. A switching circuit 200 to be controlled is provided between the output of the sensor driving circuit 26 and the connector 31, and an overcurrent circuit 202 to which power is supplied from the power source 23 and controlled by the microcomputer 32 is provided. The output is connected to the other input of the switching circuit 100. The microcomputer 32 normally controls the switching circuit 100 so as to supply the output of the sensor driving circuit 26 to the urine sugar sensor 13 via the connector 31. When the urine sugar sensor 13 is desired to be destroyed, the overcurrent circuit 102 is used. The switching circuit 100 is controlled so that the overcurrent output is supplied to the urine sugar sensor 13 via the connector 31. Other configurations are the same as those of the first embodiment, and thus the description thereof is omitted.

  FIG. 12 is a flowchart illustrating the operation of the fourth embodiment of the present invention shown in FIG. Only the operation of the fourth embodiment, which is different from the first embodiment, will be described.

  When the power of the urine sugar meter main body 21 is turned on, it is determined whether or not a new biosensor cartridge 11 is attached to the urine sugar meter main body 21. This is determined by whether or not the connector connection detection circuit 17 can detect. If not detected, this process is repeated.

  On the other hand, when the biosensor cartridge 11 is attached or when the biosensor cartridge 11 is attached, it is determined whether or not the biosensor is normal. This determination is performed as follows. The microcomputer 32 supplies a predetermined digital signal to the D / A converter 25 and drives the urine sugar sensor 13 with a predetermined current via the sensor driving circuit 26. The current flowing through the urine sugar sensor 13 can be sent to the A / D converter 27 via the sensor driving circuit 26, converted into a digital signal representing the current value flowing through the urine sugar sensor 13, and sent to the microcomputer 32. . The microcomputer 32 determines whether or not the current value flowing through the urine sugar sensor 13 is within the normal value range, and if the current value is within the normal value range, the microcomputer 32 determines that the biosensor cartridge has not passed its lifetime. 11 (whether it is a new biosensor cartridge or a biosensor cartridge that has been used but has not reached the end of its life) is mounted, and the process proceeds to the next step.

  The next step is not a step of blowing the fuse. In the fourth embodiment, it is determined whether or not the service life has passed.

  On the other hand, when the value of the current flowing through the urine sugar sensor 13 is not within the range of the normal value, the microcomputer 32 determines that “the biosensor is not normal” and the “instruction to remove the sensor”, that is, “sensor replacement” ”Is displayed while the urine sugar meter is disabled.

  The current value flowing through the urine sugar sensor 13 is within a normal value range, and three steps of "has the service life reached", "has it been measured", and "has the service life reached?" When it is determined that “lifetime use time has been reached” or “lifetime use count has been reached”, the microcomputer controls the switching circuit 100 and the overcurrent circuit 102 to detect overload. While the current circuit 102 is operated to generate an overcurrent, the switching circuit 100 is made to select the overcurrent output of the overcurrent circuit 102. As a result, the urine sugar meter sensor 13 is destroyed. Next, the “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed, while the urine sugar meter is disabled.

  When the biosensor cartridge 11 in which the urine sugar meter sensor 13 is destroyed is mounted as described above, the current value flowing through the urine sugar sensor 13 is not within the normal value range when it is determined whether the biosensor is normal. It is determined that “the biosensor is not normal” and the “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed, while the urine sugar meter is disabled. Since other operations are the same as those in the first embodiment, the description thereof is omitted.

  It will be understood that the effect similar to that of the first embodiment is achieved in the fourth embodiment.

Example 5
Since the urine sugar meter described above operates on a battery, the battery needs to be replaced. When the battery is replaced while the biosensor has not yet reached the end of its life, in Examples 1 to 3 described above, when the power is turned on after replacing the battery, the attached biosensor cartridge has been used. If it is determined that there is, the replacement of the biosensor cartridge is instructed. It is uneconomical to have to replace a biosensor cartridge with a new biosensor cartridge being measured only a few times. The fifth embodiment is a further improvement of the first embodiment so that such a situation does not occur. Since the fifth embodiment has the same circuit configuration as that of the first embodiment shown in FIG. 3 except that the auxiliary storage device 37 is non-volatile in the microcomputer 32, the illustration and description of the configuration are omitted. Only the operation will be described with reference to the flowchart of FIG.

When a new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and the urine sugar meter main body 21 is turned on When the urine sugar meter main body 21 is turned on, the biosensor cartridge 11 is inserted into the urine sugar meter main body 21. It is determined whether or not is installed. This is determined by whether or not the connector connection detection circuit 17 can detect. This process is repeated when the biosensor cartridge 11 is not attached.

  On the other hand, when the biosensor cartridge 11 is mounted or when the biosensor cartridge 11 is mounted, the microcomputer 32 checks whether the fuse 100 is in a conductive state via the detection and fusing circuit 106.

  When the fuse 100 is in a conductive state, it means that the attached biosensor cartridge 11 is new (unused), and the microcomputer 32 proceeds to the next step through the fuse detection and fusing circuit 106. The fuse 100 is blown out.

  If the fuse 100 is blown, the process proceeds to the next step, and the biosensor cartridge identification number (each biosensor cartridge can be discriminated, for example, serially stored in the memory of the urine sugar meter main body 21, for example, the auxiliary storage device 37. “Sensor is new” is written together with the product number), management information of the biosensor cartridge other than the start date of use is written, and a measurement counter is set in the auxiliary storage device 37, and “zero use count” is set. "Time".

  Next, the use start date / time is compared with the current date / time to determine the number of days that have elapsed since the start of use, and is compared with the lifetime use time (for example, 60 days). In this case, since the biosensor cartridge 11 is a new product, it is a matter of course that the service life has not been reached. Therefore, the process proceeds to the next step to determine whether the measurement has been performed. When the measurement is performed, the measurement number counter of the auxiliary storage device 37 is incremented by one.

  When the measurement is not performed and after the measurement number counter of the auxiliary storage device 37 is incremented by 1, the use number recorded in the measurement number counter of the auxiliary storage device 37 is set to the use limit number, that is, the life use number (200 times). ). In this case, since the biosensor cartridge 11 is a new article, since the number of times of use of the life has not been reached, the process returns to the step of determining whether or not the life use time has been reached.

After the new biosensor cartridge 11 is attached to the urine sugar meter main body 21 and the urine sugar meter is used, the power of the urine sugar meter main body 21 is temporarily turned off with the biosensor cartridge 11 attached (for example, for battery replacement). After that, when the power of the urine sugar meter main body 21 is turned on (in this case, the fuse is blown when the new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and the urine sugar meter is used).
When the urine sugar meter main body 21 is turned on, it is determined whether or not the biosensor cartridge 11 is attached to the urine sugar meter main body 21. This is determined by whether or not the connector connection detection circuit 17 can detect. Since the biosensor cartridge 11 is mounted, the microcomputer 32 checks whether the fuse 100 is in a conductive state via the detection and fusing circuit 106. In this case, since the fuse has already been blown, the microcomputer 32 determines that the fuse 100 is in a non-conductive state (disconnected state), that is, “the biosensor cartridge 11 is not new”.

  In this case, the microcomputer 32 reads the identification number of the biosensor cartridge and further accesses the auxiliary storage device 37 to collate with the “identification number of the biosensor cartridge” stored in the auxiliary storage device 37. Also, it is confirmed whether or not “sensor is new” is written in the auxiliary storage device 37. Since the biosensor cartridge 11 is not removed from the urine sugar meter main body 21 after the new biosensor cartridge is mounted, the microcomputer 32 confirms the coincidence of “the identification number of the biosensor cartridge” and the auxiliary storage device. After confirming that “Sensor is new” is written in 37, the process proceeds to the next step.

  In the next step, the use start date / time is compared with the current year / month / date to determine the number of days that have elapsed since the start of use, and is compared with the lifetime use time (for example, 60 days). If the biosensor cartridge 11 has not reached the lifetime use time, the process proceeds to the next step to determine whether or not the measurement has been performed. When the measurement is performed, the measurement number counter of the auxiliary storage device 37 is incremented by one. On the other hand, when the biosensor cartridge 11 has reached the lifetime use time, the writing of “sensor is new” in the auxiliary storage device 37 is erased.

  When the measurement is not performed and after the measurement number counter of the auxiliary storage device 37 is incremented by 1, the use number recorded in the measurement number counter of the auxiliary storage device 37 is set to the use limit number, that is, the life use number (200 times). ). If the biosensor cartridge 11 has not reached the number of times of use, the process returns to the step of determining whether or not the life use time has been reached. On the other hand, if the biosensor cartridge 11 has reached the number of times of use, the writing of “sensor is new” in the auxiliary storage device 37 is erased.

After the writing of “sensor is new” in the auxiliary storage device 37 is erased, the “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed, while the urine sugar meter is disabled.
After issuing an instruction to remove the sensor, the operation of determining whether the sensor is attached is repeated. When the biosensor cartridge 11 is removed, the “instruction to remove the sensor” is erased, and the operation returns to the “determination operation as to whether the sensor is attached” immediately after the power is turned on.

  In the case of the fifth embodiment, after a new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and the urine sugar meter is used, the biosensor cartridge 11 is once removed from the urine sugar meter main body 21 and the biosensor again. Even when the cartridge 11 is attached to the urine sugar meter main body 21, the fuse is blown when the cartridge 11 is attached to the urine sugar meter main body 21 in a new state and used, but the identity of the biosensor cartridge is confirmed. So it can be used.

  However, when another used biosensor cartridge 11 (fuse is blown) is attached to the urine sugar meter main body 21, the biosensor cartridge cannot be used because the identity of the biosensor cartridge is not confirmed. On the other hand, when a completely new biosensor cartridge 11 is attached to the urine sugar meter main body 21, the process after confirming the new biosensor cartridge 11 goes to the step of fusing the fuse. The number is not compared with the “biosensor cartridge identification number” stored in the auxiliary storage device 37. On the other hand, after the step of blowing the fuse 100, the biosensor cartridge identification number (for example, the serial product number can be distinguished one by one) in the memory of the urine sugar meter main body 21, for example, the auxiliary storage device 37. At the same time, "Sensor is new" is overwritten, the start date of use and other biosensor cartridge management information are written, and a measurement number counter is set in the auxiliary storage device 37. The operation when the new biosensor cartridge 11 is mounted on the urine sugar meter main body 21 is performed.

Example 6 and Example 7
Example 2 and Example 3 can also be improved like Example 5. In the sixth and seventh embodiments, the second and third embodiments are improved as in the fifth embodiment. The flowcharts are shown in FIGS. 14 and 15, and the description thereof is omitted.

Example 8
FIG. 16 is a block diagram illustrating an electrical configuration of the eighth embodiment. As can be seen from the comparison with Example 3 shown in FIG. 9, Example 8 shown in FIG. 16 can be rewritten in place of the nonvolatile memory 108 that does not necessarily need to be rewritten as Example 3 shown in FIG. A nonvolatile memory 108A such as an EEPROM or a flash memory is housed in the housing 12 shown in FIG. Note that the nonvolatile memory 108A does not need to be rewritable according to the method of use when it has a memory capacity, and can also be configured by EPROM.

  The nonvolatile memory 108A such as an EEPROM or a flash memory is provided in the biosensor cartridge 11 according to the present invention, and records the use history of the biosensor cartridge 11, that is, the biosensor. It is read and written by serial communication. As will be described in detail later, when the biosensor cartridge 11 is mounted on the urine sugar meter main body 21 and electrically connected, the microcomputer 32 reads the nonvolatile memory 108A and reads the mounted biosensor cartridge. 11 usage history is confirmed. For example, when the attached biosensor cartridge 11 has exceeded the number of times of use or the life of use since the start of use, the biosensor cartridge replacement display is displayed on the display device 29 and the urine sugar meter itself is Put it in a state where it cannot be measured.

  Example 8 of the present invention prevents a biosensor of a home digital urine sugar meter from being used beyond its service life (elapsed time and number of measurements since the start of use). This will be described with reference to the flowchart of FIG. In addition, at least the date of manufacture is stored in advance in the non-volatile memory 108A of the unused biosensor cartridge 11, and after the biosensor cartridge 11 is attached to the urine sugar meter main body 21 and started to be used, At least the start date / time of use and the number of uses are written, and various histories are recorded as necessary, as in the embodiments described below.

  Therefore, in the embodiment described below, the non-volatile memory 108A of the biosensor cartridge 11 has an area for recording the date of manufacture, an area for storing the start date of use, and an area for storing the number of times of use (measurement). Frequency counter), an area for storing a low temperature abnormality (low temperature counter), an area for storing a high temperature abnormality (high temperature counter), and an area for storing various errors (error state memory). Therefore, when the urine sugar meter 1 is turned off while the urine sugar meter 1 is inserted into the stand 41 and stored, if the urine sugar meter 1 is turned on prior to use, the number of past uses, etc. If the usage history is not over and the usage history has not passed and there is no problem in the usage history, the biosensor can be used. Alternatively, even if the biosensor is once removed from the urine sugar meter main body 21 before the life of the biosensor has passed and is attached to the urine sugar meter main body 21 again, if the service life has not expired, the use that has been attached again. A biosensor that has not expired can be used again.

  When the urine sugar meter main body 21 is turned on, it is determined whether or not the biosensor cartridge 11 is attached to the urine sugar meter main body 21. This is determined by whether or not the connector connection detection circuit 17 can detect. This process is repeated when the biosensor cartridge 11 is not attached. On the other hand, when the biosensor cartridge 11 is attached or when the biosensor cartridge 11 is attached, the nonvolatile memory 108A of the biosensor cartridge 11 is accessed and the stored contents are read.

  When only the date of manufacture of the biosensor cartridge 11 can be read, it means that the attached biosensor cartridge 11 is unused, and the usable period (for example, one year) from the date of manufacture of the biosensor cartridge 11 ) Is not passed. When the usable period has elapsed, the “instruction to remove the sensor”, that is, the “sensor replacement” on the display device is displayed, and the urine sugar meter is made incapable of measurement. If the usable period has not elapsed, the date / time at that time is written in the nonvolatile memory 108A of the biosensor cartridge 11 as the use start date / time of the biosensor cartridge 11, and the process proceeds to the next step.

  When the nonvolatile memory 108A of the biosensor cartridge 11 is accessed and the stored contents are read, if the start date of use is recorded in addition to the date of manufacture, the biosensor cartridge 11 is used. This means that the biosensor cartridge 11 has been used in the middle or in the past. In that case, first determine whether the usable period has passed since the date of manufacture, and if the usable period has not passed, compare the start date of use with the current date. Then, the number of days elapsed from the start of use is obtained and compared with the life use time (for example, 60 days), and the use number is compared with the use limit number, that is, the life use number (200 times). When the lifetime usage time has passed or the lifetime usage count has been reached, the “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed, while the urine sugar meter is disabled.

  Preferably, after the elapsed time has passed a predetermined period (for example, 53 days) or when the number of measurements has exceeded a predetermined number of times (for example, 190 times), for example, “sensor replacement” of the display device is continuously lit. While the sensor replacement warning is issued, the urine sugar meter itself is maintained in a measurable state, and after the lifetime usage time (for example, 60 days) indicating the sensor lifetime has passed, or the lifetime usage in which the number of measurements indicates the sensor lifetime. When the number of times (for example, 200 times) is exceeded, for example, “sensor replacement” of the display device is blinked, while the urine sugar meter is made incapable of measurement.

  If the lifetime usage time has not passed and the lifetime usage count has not been reached, it is determined whether there is a usage history abnormality as described later. If there is an abnormality in the use history, the “instruction to remove the sensor”, that is, “sensor replacement” on the display device is displayed, while the urine sugar meter is made incapable of measurement.

  If there is no abnormal usage history, proceed to the next step. The microcomputer of the urine sugar meter main body 21 measures the passage of time. For example, once every 10 minutes, the non-volatile memory 108A of the biosensor cartridge 11 is accessed, and the elapsed time since the installation of the biosensor, that is, the start date of use is written. This is repeated through the steps described later as long as the biosensor cartridge 11 is mounted on the urine sugar meter main body 21.

  With this configuration, when the battery is removed from the urine sugar meter main body 21 and reinserted, the use start date is read by accessing the nonvolatile memory 108A of the biosensor cartridge 11. Thus, the elapsed time from the start of use can be known, and further, the number of past measurements can be known by reading the measurement number counter set in the nonvolatile memory 108A.

  Furthermore, it is always determined whether or not the urine sugar meter equipped with the biosensor cartridge 11 is inserted and stored in the stand 41. This can be detected by the stand detection reed switch 15 that reacts to the magnet 42 of the stand 41. When it is determined that the urine sugar meter equipped with the biosensor cartridge 11 is not inserted and housed in the stand 41, the elapsed time is measured, and when the predetermined time, for example, 10 minutes elapses, the biosensor cartridge 11 is The error state that is not stored in 41 is written into the error state memory of the nonvolatile memory 108A (error state storage). Further, when detecting an error state in which the biosensor cartridge 11 is not housed in the stand 41, the microcomputer 32 instructs to remove the sensor by blinking “sensor replacement” of the display device of the urine sugar meter main body 21. The urine sugar meter itself can no longer be measured. This is because the biosensor may be deteriorated if it is left in the air without being immersed in the preservation solution.

  Further, the time is measured from the time when it is determined that the urine sugar meter equipped with the biosensor cartridge 11 is inserted and stored in the stand 41. When a predetermined time, for example, 1 hour elapses, the thermistor 14 is used to measure the temperature of the biosensor. It is determined whether the measurement result is −5 ° C. or lower. If the measurement result is −5 ° C. or lower, the low-temperature counter set in the nonvolatile memory 108A is incremented by one. After that, or when the measurement result is not −5 ° C. or lower, it is determined whether or not the measurement result is 50 ° C. or higher. When the measurement result is 50 ° C. or higher, the high-temperature counter set in the nonvolatile memory 108A is incremented by one.

  After that, or when the measurement result is not 50 ° C. or higher, it is determined whether either the low temperature counter or the high temperature counter exceeds a predetermined number of times, for example, 10 times. If the predetermined number of times has been exceeded, the microcomputer 32 writes the error state in the error state memory of the nonvolatile memory 108A, and further blinks “sensor replacement” on the display device of the urine sugar meter main body 21 to remove the sensor. An instruction is given and the urine sugar meter itself cannot be measured.

  If the measurement result is not 50 ° C. or higher, or if it has not yet elapsed for one hour from the time when it is determined that the urine sugar meter equipped with the biosensor cartridge 11 is inserted and stored in the stand 41, the measurement is performed. Determine if it was done. When the measurement is performed, the measurement number counter of the nonvolatile memory 108A is incremented by one.

  When measurement is not performed (in this case, the biosensor remains immersed in the storage solution in the stand), and after incrementing the measurement number counter of the nonvolatile memory 108A by 1 (in this case, measurement After completion, the urine sugar meter is returned to the stand, the biosensor is immersed again in the storage solution in the stand), and the biosensor is driven in the state where the biosensor is immersed in the storage solution. Measure the value. When a measured value of a predetermined value or more, for example, 15 nA or more is obtained, an error state indicating that the sensor is abnormal is stored in the error state memory of the nonvolatile memory 108A (error state storage). When the microcomputer 32 detects an error state that the measurement value is abnormal while the biosensor is immersed in the preservation solution, the microcomputer 32 performs “sensor replacement” on the display device of the urine sugar meter main body 21. Blinks and gives an instruction to remove the sensor, and the urine sugar meter itself cannot measure.

  When the measurement value of less than 15 nA is obtained, the nonvolatile memory 108A is accessed again to determine whether the number of measurements or the measurement life has been reached, and whether there are various errors that require the biosensor to be replaced. If replacement is necessary, the microcomputer 32 blinks “sensor replacement” on the display device of the urine sugar meter main body 21 and issues an instruction to remove the sensor, and the urine sugar meter itself cannot be measured. Like that.

  If there is no need for replacement, the process returns to the step of updating the elapsed time once every 10 minutes.

  After issuing an instruction to remove the sensor, the operation of determining whether the sensor is attached is repeated. If the biosensor cartridge 11 is removed, the process returns to the “determination operation as to whether or not the sensor is mounted” immediately after the power is turned on.

  When the biosensor cartridge 11 is removed and attached to the biochemical measuring instrument body again, the elapsed time, the measurement number counter, the low temperature counter, the high temperature counter, which are recorded in the non-volatile memory 108A of the biosensor cartridge 11, If the microcomputer reads the error status memory and the service life indicating the sensor life has passed, if the usage count limit indicating the sensor life is exceeded, or if the temperature abnormality continues for a long time, the sensor is not stored. When the error state is detected, or when the error state that the sensor is abnormal is detected, the microcomputer 32 blinks “sensor replacement” on the display device of the urine sugar meter main body 21 and instructs to remove the sensor. At the same time, the urine sugar meter itself makes it impossible to measure and prompts to replace it with a new sensor.

  In the above flow of operations, if the measurement is started before the step of determining whether the measurement has been performed, the operation is interrupted and whether the measurement has been performed after the measurement has been performed. The process is resumed from the step of determining.

As described above, according to the present invention, the sensor performance cannot be maintained by referring to a counter or the like (provided in the non-volatile memory of the biosensor cartridge) indicating the sensor life and sensor performance deterioration. If it is determined, a measuring device such as a urine sugar meter can be disabled.

  Specifically, there is no need for a device that stores the current time (year / month / day / time), and the device can be managed by purely the elapsed time so that it cannot be used beyond the sensor life of the biosensor. In addition, it is possible to prevent use with the number of measurements exceeding the sensor life.

  Furthermore, when exposed to abnormal temperatures for a long time, there is a great risk that the sensor performance will deteriorate, but in such a case, the measuring instrument can be made unusable. Also, if the sensor is left in a state where it is not stored in the preservation solution bottle, there is a great risk that the sensor will dry and the performance will deteriorate, but in such a case, the measuring instrument should not be used. be able to.

  In addition, when it is determined that the measured value is abnormal in a state where the sensor is immersed in the storage solution, it is possible to prevent the measurement instrument from being used thereafter.

Effect of Embodiment 8 Thus, according to the present invention, a biosensor cartridge (for example, a biosensor substrate accommodated in the biosensor cartridge) is provided with a non-volatile memory that stores the elapsed time and the number of measurements since the sensor is mounted. Thus, even if the sensor is once removed and attached, it can be determined whether or not the sensor has already expired, and misuse (unauthorized use) can be prevented.

  In addition, there is no need to provide a switch for setting the current time, and a backup power supply is prepared so that the time data will not disappear when the battery of the biochemical measuring instrument is removed, or the time is adjusted again after the battery is inserted. There is no necessity, and the apparatus is not increased in size and the user is not required to take a difficult time.

  If the sensor has been exposed to abnormal temperature for a long time, if the sensor is left in a state where it is not stored in the preservation liquid bottle, if the sensor is immersed in the preservation liquid and the measured value is abnormal, Even if the sensor is once removed and attached, it is determined whether or not the possibility that the performance of the sensor has deteriorated is large, and misuse (unauthorized use) can be prevented.

Example 9
One factor that affects the life of the biosensor that can be maintained is the integration of the time of immersion in the measurement object. As the accumulated time immersed in the measurement object becomes longer, the performance deteriorates. According to another embodiment of the present invention, the accumulated time can be stored in the non-volatile memory on the biosensor so that the measurement cannot be performed after the accumulated time exceeds a predetermined time. If the measured object has a high concentration, the progress of performance degradation of the biosensor becomes faster, so the accumulated value of the time immersed in the measured object at a predetermined concentration or more is memorized and the predetermined time is exceeded. After that, measurement can be disabled.

Example 10
In Example 8 described above, the nonvolatile memory 108A is electrically connected to the microcomputer 32 via the connectors 16 and 31, but wireless transmission / reception means are provided for the biosensor cartridge 11 and the urine sugar meter main body 21, respectively. By providing, it is also possible to wirelessly connect the nonvolatile memory 108A and the microcomputer 32.

Example 11
Biosensors have variations in sensitivity that change over time. Therefore, it is necessary to calibrate at the stage of starting use and every predetermined time or every predetermined number of times.

  Utilizing the fact that the non-volatile memory 108A is provided in the biosensor cartridge 11 in the eighth embodiment, a calibration coefficient, a part for storing the elapsed time at the time of calibration, and a calibration measurement counter are stored in the non-volatile memory. Provide. In addition, a calibration switch is provided in the biochemical measuring instrument body.

  Calibration is performed as follows. When the stunt detection reed switch that detects storage liquid bottle storage is turned on, that is, when it is detected that the sensor has been removed from the storage liquid bottle, it has been removed from the storage liquid bottle but is still infiltrated with the storage liquid. A sensor is driven by a sensor driving circuit to obtain a measurement value and stored in a non-volatile memory of the biosensor cartridge. Next, after a calibration switch is pressed, a predetermined time is detected after detecting that a measured value has changed (for example, 0.5 nA) by applying a reference solution having a predetermined concentration (for example, 500 mg / dL), For example, the measurement value after 10 seconds is obtained and stored in the non-volatile memory of the biosensor cartridge. By subtracting the measured value in the state where the sensor is immersed in the storage solution from the measured value after 10 seconds, a calibration coefficient is obtained so as to obtain a predetermined concentration, and simultaneously stored in the non-luminous memory, The elapsed time at this time is stored as the elapsed time at the time of calibration. Also, the calibration measurement counter is cleared to zero.

  At the time of measurement, after detecting that the storage liquid bottle storage switch is turned off, i.e., that the sensor has been removed from the storage liquid bottle, the calibration point in the non-volatile memory on the sensor from the current elapsed time is detected. The elapsed time is reduced, and if it is a predetermined time, for example, one week or more, a message indicating that calibration is necessary is displayed on the display device. Further, when the calibration measurement number counter reaches a predetermined value or more, for example, 50 times, the display device displays that calibration is necessary.

  In other cases, a measurement value after a predetermined time, for example, 10 seconds, is obtained from the measurement value in a state where the sensor is immersed in the storage solution after detecting that the measurement value has changed (for example, 0.5 nA). Then, the measurement value in a state where the sensor is immersed in the storage solution is subtracted from the measurement value after 10 seconds, the calibration coefficient is called from the non-volatile memory on the sensor, and the measurement result is obtained by multiplication, and the display device And the counter for the number of times of measurement for calibration of the nonvolatile memory on the sensor is incremented by one.

  By placing various parameters in the nonvolatile memory on the sensor in this way, it becomes easy to remove the sensor and store it separately. If the sensor is immersed in the storage solution, the sensitivity hardly changes. Therefore, if the sensor is immersed in the storage solution, it can be removed from the main body of the biochemical measuring instrument and stored compactly.

  When the sensor is removed, the microcomputer continuously measures the elapsed time, but does not store the elapsed time in the memory on the sensor every predetermined time. Moreover, temperature measurement is not performed once in a predetermined time.

  As mentioned above, although the Example of this invention was described about the urine sugar meter, this invention is equally applicable to the biochemical measuring device in which the biosensor part with a use life other than a urine sugar meter is removable to a measuring device main body. It will be understood by a person skilled in the art that there is nothing to explain.

DESCRIPTION OF SYMBOLS 1 Urine sugar meter 11 Biosensor cartridge 12, 22 Housing 13 Urine sugar sensor 14 Thermistor 15 Stand detection reed switch 16, 31 Connector 17 Connector connection detection circuit 21 Urine sugar meter main body 23 Power supply 24 (24a, 24b) Operation button 25 D / A converter 26 Sensor drive circuit 27 A / D converter 28 Buzzer 29 Display device 30 External input / output interface terminal 32 Microcomputer 33 Arithmetic and control device 34 ROM
35 RAM
36 clock 37 auxiliary storage device 38 external input / output interface 41 stand 42 magnet 100 fuse 106 fuse detection and fusing circuit 108, 108A nonvolatile memory 200 switching circuit 202 overcurrent circuit

Claims (8)

  A biochemical measuring instrument using a biosensor cartridge, wherein a biosensor cartridge including a biosensor is configured to be detachably connected to a main body of the biochemical measuring instrument. The biosensor cartridge is used by the biosensor cartridge. The biochemical measuring instrument main body has a built-in used indicating means for instructing that it has been used, and the biochemical measuring instrument main body has a writing means for writing used information to the used indicating means, When the biosensor cartridge that has not been used is not instructed by the used instruction means is connected to the biochemical measuring device main body, the control means causes the writing means to write used information to the used instruction means. At the same time, after it is determined that the biosensor has reached the end of its life, the biochemical measuring instrument main body displays a “bye”. When the biosensor cartridge that has been used once is connected to the main body of the biochemical measuring instrument, the replacement of the sensor cartridge is displayed, while the used indicating means indicates that the sensor has been used. The control means of the device main body can display “Replace Biosensor Cartridge” on the display device of the biochemical measuring device main body and prevent the measurement using the unusable biosensor cartridge. A biochemical measuring device configured as described above.   The control means of the biochemical measuring device body is characterized in that, when a new biosensor cartridge is connected to the biochemical measuring device body, the writing means writes the used information in the used instruction means. The biochemical measuring device according to claim 1.   The used instruction means is a fuse, the writing means is a fuse blowing means, and the state in which the fuse is blown indicates that the biosensor cartridge has been used. The biochemical measuring device according to claim 1 or 2.   The biochemical measuring instrument according to claim 3, wherein the fuse is provided independently of a connector connection detection circuit of the biosensor cartridge.   The biochemical measuring instrument according to claim 3, wherein the fuse also serves as a connector connection detection circuit of the biosensor cartridge.   The used instruction means is a non-volatile memory, and a state written as used in the non-volatile memory indicates that the biosensor cartridge has been used. Item 3. The biochemical measuring device according to Item 1 or 2.   The control means of the biochemical measuring device main body, when the writing means writes the used information in the used indicating means, the storage means in the biochemical measuring device main body stores the identification number of the biosensor cartridge and When the management information is written and attached to the biosensor cartridge biochemical measuring instrument body that has been used, even if the used instruction means indicates that it has been used, the identification number of the attached biosensor cartridge Coincides with the identification number of the biosensor cartridge stored in the storage means in the biochemical measuring device body, and from the management information stored in the storage means in the biochemical measuring device body, the biosensor When it is determined that the cartridge has not reached the service life, the biosensor cartridge is displayed on the display device of the biochemical measuring instrument body. Wherein the not displayed exchange ", biochemical measuring instrument according to any one of claims 1 to 6.   The biochemical measuring instrument using the biosensor cartridge according to any one of claims 1 to 7, wherein the biochemical measuring instrument is a urine sugar meter.

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