JP2849809B2 - A device that measures body fluid components and stores and manages the test data. - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention records a time-varying measurement value in various clinical tests using a solid phase reagent together with measurement time data, and grasps the state of a patient from the state of the fluctuation.
The present invention relates to a method and apparatus for storing and managing inspection data at the same time as measurement, and a method for managing and processing inspection data. Currently, clinical testing techniques using various analyzers and reagents to detect and diagnose latent or actual diseases, confirm the effects of treatment, and monitor changes in pathological conditions have been established for many diseases. Is widely practiced.
However, these clinical tests generally require a high level of skill and knowledge, and judgments based on test results are generally made at medical institutions because they require specialized knowledge.
However, continuous measurement is necessary when confirming the effects of treatment or monitoring changes in the state of the disease, and especially when long-term home care is required, going to the hospital every time requires a large mental, physical and economical burden on the patient. There are problems such as inconveniences such as deterioration of medical condition caused by imposing a burden and neglecting the examination.
For example, the basics of the treatment of diabetes are diet therapy, exercise therapy, and drug therapy. In particular, in the case of insulin-dependent diabetic patients and diabetic pregnant women, it is a major problem to control blood sugar levels to an appropriate range by insulin injection. Therefore, patients often had to go to the hospital and watch the doctor's instructions while paying attention to their daily diet. In order to eliminate such inconvenience, patients have recently performed various tests using analytical tools and measuring instruments equipped with simple measurement reagents (solid phase reagents) that can be easily used by amateurs, and the measured values were recorded on memo paper or the like. Home that provides confirmation of treatment effects, monitoring / understanding of changes in pathological condition, new instructions to patients, etc. by recording, reporting to doctors at a later date, and observing the fluctuations by doctors (and patients) Management techniques called monitoring (home monitoring) or self-monitoring (self-monitoring or self-measurement) are being adopted for testing. Since this technique can be performed at home, frequent measurements can be performed, and the patient's own sense of participation can be stimulated, and significant effects such as correct self-management in daily life can be achieved. In addition, the solid phase reagent here means a carrier such as filter paper impregnated with the reagent,
A film obtained by mixing a reagent and a polymer substance is referred to as a film. The solid-phase reagent fixed on a strip or piece-shaped support for convenient use is referred to as an analysis tool. However, in the case of conventional home monitoring, patients record and print out what is once recorded and reported to the physician at the next hospital visit, so it is easy to make mistakes when posting or reporting measurement values and the transcription itself. But very annoying. Although continuous changes are difficult to understand unless they are graphed, graphing is troublesome, and the number of patients handled by one doctor, including transcription, is limited. It is spicy. Of these, the problems of transcription errors and annoyance of primary data on the patient side and the problem of data processing on the doctor side are particularly large. Furthermore, the time (or the amount and degree) of the patient receiving an external action such as medication or injection has a great effect on the measured value,
It is cumbersome to accurately record the time and amount, and the transfer is troublesome, and recording and transcription mistakes are likely to occur. The present invention has been made in order to solve such disadvantages.In order to increase the reliability of data by objective measurement by instrumental analysis and promote home monitoring to raise patient's control awareness, measurement and recording are integrated. To prevent transcription errors and reduce the labor burden on the patient side, reduce the labor burden such as organizing the data of many patients and tabulating the data on the physician side, and further reduce the data transcription error on the physician side It is an object of the present invention to provide a method for preventing or reducing data transfer effort. It is another object of the present invention to provide a measurement management device which is small and lightweight, can be operated very easily and can perform accurate measurement, and can record measured value data and measurement time data. Hereinafter, the method and apparatus of the present invention will be described in detail with reference to the drawings. FIG. 1 and FIG.
FIG. 1 shows an example of a measurement management device for measuring body fluid components and managing test data according to the present invention. This measurement management device (1) is for a diabetic patient who measures glucose concentration in blood using an optical system for measuring reflected light in an analyzer (2). Further, in addition to the analysis unit (2), an operation unit (3), a display unit (4), a control operation unit (5), a clock circuit (6), a storage circuit (7), a data output circuit (8), and the like are configured. Have been. The symbol (9) in FIG.
(10) is a light quantity standard reflection piece attached to the back surface of the lid (9). The analysis unit (2) includes an integrating sphere (11), a light source (12), a photodetector (13), an amplifier (14) and A
-D converter (15). The control operation unit (5) is composed of an oscillation circuit (16) and a one-chip microcomputer including a CPU, ROM, RAM, I / O and the like.
The operation unit (3) includes an ON / OFF key (17), a start key (18), a measure key (19), a calibration key (20), and a memory store key (2).
1), a memory read key (22) and a memory clear key (23) are provided. In FIG. 1, reference numeral (24) denotes a dry battery as a driving power source, (25) denotes a constant voltage circuit, (26) denotes a lighting circuit, (27) denotes an analog switch, and (28) denotes a buzzer. The use of a dry battery (including a rechargeable battery) as a driving source makes the entire apparatus compact and lightweight, but of course it is also possible to use an AC adapter or use a commercial power supply as it is. Next, the procedure for measuring the blood glucose concentration of the illustrated device (1) will be described. First, prior to measurement, an analysis tool (B) provided with a solid phase reagent for glucose analysis (A) and a blood sample are prepared, and the power is turned on by pressing an ON / OFF key (17). Next, when the start key (18) is pressed, the oscillation circuit (16) as a timer operates. At the same time, the sample is applied to the solid phase reagent (A) of the analysis tool (B). After 60 seconds, the buzzer (28) sounds, so that excess blood is wiped off, the analysis tool (B) is set in the analysis section (2), and the lid (9) is closed. After 120 seconds, the buzzer (28) sounds again, the light source (12) is turned on at the same time, the light reflected on the reacted solid phase reagent surface is converted into an electric signal by the photodetector (13), and the A / D converter ( It is digitized in 15) and input to the control operation unit (5). The reflectivity of the solid phase reagent (A) surface is obtained by measuring the light quantity (reference signal quantity) of the light quantity standard reflection piece (10) measured when the power switch is turned on or the start key (18) is pressed. It is measured as the relative reflectance to
Next, a density value is calculated from the relative reflectance and the calibration curve set in the control calculation unit (5) to obtain a measured value, and the value is displayed on the display unit (4) as a measurement result. This calibration curve is set by a calibration operation. In the calibration operation, after turning on the power, the calibration key (20) is pressed to set the calibration mode, and the low-concentration and high-concentration standard reflectors (or the solid phase reagent coated with the standard solution) are set in the analysis unit, respectively. This is performed by pressing the major key (19). The calibration value is stored in the memory of the control operation unit (5),
Since the data is stored even when the power switch is turned off, it is not necessary to perform the operation at all times, and may be performed as needed at the time of battery replacement, when changing the analytical tool lot, or when the ambient temperature changes greatly. Next, when the memory store key (21) is pressed while the measurement result is displayed on the display section (4), the measured value is stored in the storage circuit (7). At the same time, the output data of the clock circuit (6) at the time of measurement, that is, the date and the measurement time are read out, automatically added and stored. Further, a serial number is added to the data within the same date by the counting circuit, and the data is also automatically stored. The date may be a calendar day (year, month, day) and the time may be up to hours and minutes. However, since the storage circuit (7) has a small capacity, the number of days elapsed in a series of measurements is taken as the date. You may make it memorize | store roughly every 2 hours. Further, the storage of the measured value may be automatically performed at the same time when the measured value is displayed on the display unit (4). The clock circuit (6) and the storage circuit (7)
Even when the power switch is off, power is supplied from the battery (24) and the power switch is always operated. Further, a battery for memory backup may be provided to deal with the erasure of the measured value and the calibration value when replacing the battery (24). The measurement value data erroneously stored in the storage circuit (7) can be cleared immediately after storage by using the memory clear key (23). The measured value data stored before that can be cleared by simultaneously pressing the memory read key (22) and the memory clear key (23). Both (22) and (2)
Keeping pressing 3) clears all data and resets the elapsed days timer at the same time. The memory read key (22) is also used for reading stored measurement value data, and the stored contents can be displayed one by one on the display unit (4) when necessary. When the key (22) is kept pressed, the stored data is sequentially called out on the display section (4). Next, the operation of the action key (29) will be described. The action key (29) is operated when the patient takes any action from outside such as taking an insulin injection, taking a drug, or taking in sugar for a glucose tolerance test, and the action is performed. In addition to displaying the time taken and the time on the display unit (4),
The data is stored in the storage circuit (7), and is provided as needed. Further, a numeric keypad (not shown) may be provided in the measurement management device (1) in order to record the amount of one dose of insulin injection or other medicine. In these cases,
When the data is displayed on the display unit (4) in the same manner as the measured value data, the memory store key (21) may be pressed to store the data in the storage circuit (7), or simultaneously with the display on the display unit (4). The information may be automatically stored in the storage circuit (7). Further, it is preferable that data stored by mistake can be cleared by the memory clear key (23). Thus, the measured value data and the fact that the external action was performed (and the amount of the medicine) are stored in the storage circuit (7) together with the output data of the clock circuit (6) at each time, and the external action is measured. The effect on the value can be easily and reliably captured. However, since the external action such as injection or medication is performed according to the instruction of the doctor, the method of inputting the time of the external action and particularly the amount of insulin to the external device may be adopted as described later. Thus, the patient operates the measurement management apparatus (1) by himself, and accumulates a continuous change of the blood glucose level at a fixed time every day or on a specific day as a large number of data in the storage circuit (7). Then, all the stored measurement data or the measurement data on a specific day can be called up to obtain a rough feel of the change in the blood sugar level, the physical condition, and the therapeutic effect. At the same time, the patient goes to a hospital or a diabetes center about twice a month (or whenever the condition becomes worse or suddenly changed), and hands the measurement management device (1) to the doctor. Then, as shown in FIG. 3, the doctor replaces the data output circuit (8) of the individual measurement management device (1) submitted by each patient with the data input circuit (31) of the data recording device (30) as an external device. And presses the memory read key (22) of the measurement management device (1), and stores each data stored in the storage circuit (7) of the measurement management device (1) into the storage circuit (30) of the data recording device (30). 32). The memory read key (22) also has a function of determining whether or not a connector of the data output circuit (8) is connected. In FIG. 3, reference numeral (33) denotes a data recording device (3).
A control operation unit 0), an operation unit 34, a display unit 35, and a printer unit 36 are shown. Further, the connection between the measurement management device (1) and the data recording device (30) may be connected via a connector (37), or by indirect means such as using a telephone line and an acoustic coupler. In the above example, the output of the measurement management device (1) is directly transferred from the data output circuit (8) to the data input circuit of the data recording device (30). The display may be sequentially displayed on the display unit (4) of the management device (1), and a doctor, a nurse, an inspection staff, or the like may input a key to the data recording device (30) while watching the display. When this method is adopted, the data output circuit (8) of the measurement management device (1) can be omitted. Thus, when all the data of one time stored in the measurement management device (1) is transferred to the storage circuit (32) of the data recording device (30), the buzzer (28) of the measurement management device (1) is activated. Sounds to signal the end of output. At the same time, all the stored data is automatically (or key operated, and furthermore, the data recording device (3
0) may be deleted, and the next elapsed day timer is reset again from that point. On the other hand, in the data recording device (30), all data for the current time is displayed on the CRT of the display unit (35) by key operation of the operation unit (34), and if necessary, a table (see FIG. 4 for an example) is displayed. Show)
Or it is displayed in the form of a graph (an example of which is shown in FIG. 5). The physician inputs information specifying the individual, such as the patient's name, age, gender, and code number, necessary for the data group by key operation, and also inputs supplementary data such as the date and time of the insulin injection and the amount of the injection. However, the input of the information is performed prior to the transfer of all the data for each measurement, for each measurement management device (1), including the case where the data of many measurement management devices (1) are continuously transferred. Alternatively, the supplementary data is unnecessary in the case of a system in which the patient inputs the measurement management device (1). The data, tables and graphs shown on the CRT can be printed out by the printer unit (36). Thus, the management status of the blood sugar level can be grasped at a glance. In addition, in the preparation of the table, following the classification of the patient's name, age, gender, etc., the serial number,
The measurement date, time, measurement value, serial number for each measurement date, etc. are printed (FIG. 4). The comment column in FIG. 4 describes the doctor's prescription, the amount of insulin injection, the date and time, and the like. Graph (fifth
In the case of (FIG.), The amount of insulin injection and the date and time may be represented by, for example, the length and position of the line at the top of the line graph in the figure. In addition, when creating a table or graph, indicate the control limit value of the control.For data that deviates from the limit value, add an up or down arrow to the data as a comment in the case of a table, and add a limit line in the case of a graph. May be displayed. Next, in addition to reading out or printing out all the data of one time of each measurement management device (1) each time (the above example), a data group of one time from each measurement management device (1). Can be given a data name and stored in another storage medium (eg, a floppy disk), and can be read out again when needed. For example, the data in the floppy disk can be searched by a search program, and can be used to view the transition of all past measurement values for the same patient and to check similar cases. In the floppy disk, in addition to recording and storing various data, it is possible to perform editing such as combining, inserting, and deleting respective data strings. In the above, the present invention has been described for the case where the blood glucose level is measured by the illustrated device. However, the measurement items are not limited to the blood glucose level, and can be applied to the measurement of other body fluid components. The analysis unit (2) of the measurement management device (1)
For a measurement item that is compatible with fluorescence analysis, a structure may be employed in which the amount of fluorescence is measured instead of the amount of reflected light. On the other hand, as an external device, a data recording device (a personal computer, a minicomputer, or a large computer, etc.) having the above-described control operation unit and storage circuit is used only as a printer, or simply as a recording device without an editing function. And only a printer function. On the other hand, the measurement management device (1) is used not only for home monitoring in general households, but also for individual use in hospitals by hospitalized patients, or for measurement of body fluid components and test data of multiple people in a private hospital with a small number of samples. It can also be used for storage. In the case where the measurement is performed by a plurality of persons, the normal automatic measurement in which the timer is operated by the start key (18) takes time. Therefore, it is preferable to use the immediate measurement function of immediately pressing the measure key (19) at an arbitrary time to perform measurement. . As described in detail above, the method of the present invention provides measurement data of body fluid components obtained using an analyzer equipped with a small, lightweight and portable reflectometer or fluorometer, and a solid phase reagent, The output data of the clock circuit indicating the time when the measurement was performed is stored and managed in the storage circuit of the analyzer, and when an arbitrary or predetermined number of measurement value data is accumulated, the data is output and input to the external device. A method of storing and managing test data together with the measurement of body fluid components, and furthermore, storing a stored data group of each individual device in an external device together with information for specifying an individual, and storing the data group of each individual analytical device This is a method for managing and processing test data of body fluid components, which displays numerical fluctuations or graphical representations of individual measured values over time from a plurality of data groups. Therefore, according to the method of the present invention, it is not necessary to record the measured value data and the data of the date and time of the measurement at all, accurate data can be obtained, transcription errors on the patient side can be prevented, labor burden can be reduced, and the doctor side can be reduced. Data transfer mistakes, data transfer, data
This is extremely effective for a home monitoring system. For example, it can reduce labor such as tabulation of data, and can easily create summary tables and graphs so that the disease state and treatment effect can be easily understood. In addition, it is possible to increase the effect of treatment by giving the patient's own body fluid component concentration, for example, a goal of blood sugar control, and awareness of control,
It has many advantages, such as observing the transition of a medical condition from past data and grasping clues to a treatment method for the person or another person whose data shows the same tendency. The measurement managing apparatus of the present invention, storage of the measurement and the inspection data and measurement time data of the body fluid component performed by the same device, and with available everywhere because it portable small, lightweight, can be operated is extremely simple and reliable And highly reliable measurement. Therefore, it has many advantages, such as allowing each individual at home or inpatient to self-manage and allowing a doctor to easily manage a large number of patients with a single data recording device.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a block diagram showing an example of a measurement management device according to the present invention, FIG. 2 is a perspective view of the same measurement management device, and FIG. 3 is a block diagram showing an example of a data recording device. 4 and 5 show a table and a graph, respectively, printed out by the data recording device. DESCRIPTION OF SYMBOLS 1 ... Measurement management apparatus 2 ... Analysis part 3 ... Operation part 4 ... Display part 5 ... Control calculation part 6 ... Clock circuit 7 ... Storage circuit 8 ... Data output circuit 16 ... Oscillation circuit 17 ... ON / OFF key 18 ... Start key 19 ... Measure key 20 ... Calibration key 21 ... Memory store key 22 ... Memory read key 23 ... Memory clear key 24 ... Battery 28 ... Buzzer 29 ... Action key 30 ... Data recording device 31 ... Data input circuit 32 ... Storage circuit 33 ... Control Arithmetic unit 34 Operation unit 35 Display unit 36 Printer unit 37 Connector

Claims (1)

(57) [Claims] An analyzer for home monitoring or self-monitoring, which irradiates a solid phase reagent such as a test piece coated or impregnated with a test body fluid with a light beam and performs measurement using reflected light thereof. It receives the obtained electric signal and calculates a measured value from the stored reference signal amount and calibration curve data and the obtained electric signal amount, and outputs the measured value to a display unit. An oscillation circuit, CPU, ROM, RAM , I
A one-chip microcomputer including / O, etc., an operation unit for giving an operation command to the microcomputer from the outside, a display unit for displaying a measurement result, a clock circuit, and an output and a measurement result of the clock circuit during measurement. A storage circuit for storing, a data output circuit for outputting data to an external device, and operating when an action that affects the body fluid is taken from the outside of the patient, whereby the action is taken and the An action key that stores the time in a storage circuit and a memory read key that reads the stored data to a display unit are integrally provided. The body fluid component is measured and the test data is stored and managed. Equipment to do.