JP4744976B2 - Biological information measuring apparatus and method - Google Patents

Description

  The present invention relates to biological information that non-invasively measures substance concentration in blood or biological tissue cells or body fluids outside the cells, or physical property information of biological tissues for health management, diagnosis and treatment of diseases, and beauty, for example. The present invention relates to a measuring apparatus and a method thereof.

  Heart diseases such as myocardial infarction and cerebrovascular diseases such as cerebral infarction, which are the main causes of death in modern times, are called lifestyle-related diseases. Most of these lifestyle-related diseases are caused by arteriosclerosis caused by hypertension, diabetes, abnormal lipid metabolism, obesity, smoking and the like. Many of these high-risk conditions such as hypertension, diabetes, and abnormal lipid metabolism, even when diagnosed by a medical examination, are less likely to cause symptoms until the disease state has progressed considerably. A patient with such a medical condition measures biological information such as blood pressure and blood sugar by himself / herself at the frequency and time given during daily life, taking medicines as prescribed, instructed exercise, Often self-management such as meals.

  Among these, in blood glucose measurement, which is one of the important indicators of diabetes, a small amount of blood sample is collected by inserting a needle into a part of a part such as a finger or arm by the patient as a subject, and this collected blood A so-called self blood glucose meter is widely used, in which glucose is chemically reacted and its concentration is measured. As the most common method for measuring the glucose concentration of this self blood glucose meter, there is a method using an enzyme electrode. An example of an enzyme used for glucose detection is glucose oxidase (GOD). Glucose concentration is measured by, for example, immobilizing GOD on a polymer membrane and the like, and oxygen in the patient's substance comes into contact with the GOD-immobilized membrane, so that oxygen changes are captured. . Such a blood collection type self blood glucose meter has a portable size and is used for management of blood glucose level of a subject having diabetes.

  However, in the measurement of glucose concentration using a blood-collecting self-blood glucose meter, it is necessary to puncture a part of a finger, arm or the like for blood collection, which damages the subject's skin and causes pain. On the other hand, there is a measurement method aimed at reducing the skin damage and pain of the subject. For example, a method of measuring by measuring a minute amount of cell interstitial fluid by opening a minute hole on the skin surface using a fine needle or laser, and applying a voltage or ultrasonic wave to the skin surface. There is a method for improving the leaching permeability and extracting and measuring a leachate such as a cell interstitial fluid, and a non-invasive measurement method that does not require blood collection or extraction of a cell interstitial fluid.

  Among these, as a non-invasive measurement method, for example, there is a method using an electromagnetic wave as disclosed in Patent Document 1 or Patent Document 2. In these Patent Documents 1 and 2, near-infrared light having a plurality of different wavelengths is irradiated on the skin surface of the subject, and the light from the skin surface is detected, and the detection signal is measured as a reference signal. There is disclosed a method of measuring the component and concentration of a substance present in a subject by dividing these into signals and performing arithmetic processing on these values.

In such a non-invasive measurement method, so-called calibration is performed in which a correlation between a desired substance concentration value obtained by collecting a body fluid such as blood in advance and a non-invasively obtained signal is obtained. Then, the desired substance is quantified from the non-invasively obtained signal based on the calibrated correlation.
However, the non-invasive measurement method is affected by factors such as the circadian rhythm (diurnal rhythm) of the subject, meal intake time, sleep time, physical condition, medical condition, medication, and the like, resulting in a decrease in measurement accuracy.
Japanese Examined Patent Publication No. 3-47099 Japanese Patent Publication No. 5-58735

  The object of the present invention is to provide information on substances in a subject with high accuracy without being affected by factors such as circadian rhythm (daily rhythm) of the subject, meal intake time, sleep time, physical condition, medical condition, and medication. An object of the present invention is to provide a biological information measuring apparatus and method that can be calculated.

A biological information measuring apparatus according to a main aspect of the present invention includes a measurement unit that non-invasively measures a substance in a subject, an information input unit that inputs life information of the subject, and a substance measured by the measurement unit. An optimization unit that optimizes the parameters of the calibration model set for each of a plurality of measurement time zones based on the life information input from the information and the information input unit according to the life information, and the optimization unit A substance information calculation unit that calculates information on the substance using the parameters of the calibration model optimized by the above.

The biological information measuring method according to the main aspect of the present invention non-invasively measures the substance information in the subject by the measuring unit, inputs the living information of the subject through the operating unit, The parameters of the calibration model set for each measurement time zone based on the measured substance information and the life information input via the operation unit are optimized and optimized according to the life information. Information on the substance is calculated from the parameters of the calibration model .

  According to the present invention, information on substances in a subject can be obtained with high accuracy without being affected by factors such as circadian rhythm (daily rhythm) of the subject, meal intake time, sleep time, physical condition, medical condition, and medication. It is possible to provide a biological information measuring apparatus and method that can be calculated.

Hereinafter, a first embodiment of the present invention will be described with reference to the drawings.
FIG. 1 shows an external view of the biological information measuring apparatus, and FIG. 2 shows a block configuration diagram of the apparatus. The apparatus includes, for example, a light irradiation point and a light receiving point as disclosed in Japanese Patent Publication No. 6-103257, Japanese Patent Publication No. 2002-515277, US Pat. No. 5,551,422 and US Pat. No. 5,770,454. A spatially resolved diffuse reflection method for calculating the absorbance of a substance from a plurality of measurement data having substantially different light diffusion optical path lengths by changing the distance, for example, JP-A-10-325794, JP-A-11-506207, and the United States The glucose concentration in the body of the subject is measured using a method that uses light of a plurality of wavelengths as disclosed in Japanese Patent No. 5747806.
Hereinafter, a specific configuration of the apparatus will be described. As shown in FIG. 1, a display screen 2 a of the display unit 2, an operation button 3 of the operation unit 3, a power button 4 of the power supply unit 4, and a finger of the subject H are held on the surface of the apparatus housing 1. For example, a sensor window 5 formed in a U-shaped groove is provided. The sensor window 5 may hold, for example, an arm of the subject H, and the shape thereof can be changed according to the shape of the portion of the subject H to be held. A communication port 6 is provided on one side surface of the apparatus housing 1. The communication port 6 enables data communication such as bi-directional transfer of various data, program data, and the like with an external device via a communication line.

In the apparatus housing 1, as shown in FIG. 2, a measurement unit M that non-invasively measures a substance in the subject H and acquires time information when the substance in the subject H is measured is provided. Yes. The measuring unit M is provided with a light source unit 7. The light source unit 7 outputs monochromatic light having a desired wavelength, a plurality of monochromatic lights having different wavelengths, or light having a wavelength close to these monochromatic lights. The light source unit 7 uses a small light emitting element such as a semiconductor laser (LD) or a light emitting diode (LED). The light source unit 7 uses one or a plurality of light emitting elements such as LDs or LEDs that output light of a desired wavelength. The multiplexing unit 8 superimposes monochromatic light of each wavelength of the light output from the light source unit 7 on the same optical axis. The irradiation / light-receiving unit 9 irradiates a desired one site or a plurality of measured sites of the subject H via the interface unit 10 with light obtained by superimposing monochromatic light of each wavelength on the same optical axis by the multiplexing unit 8. In addition, the optical axis of each light for simultaneously receiving each light diffused, transmitted, or reflected through a desired site or a plurality of sites to be measured of the subject H is controlled. As shown in FIG. 1, the interface unit 10 is provided, for example, at the bottom of the subject holding unit 5, irradiates the subject H with light from the irradiation / light receiving unit 9, and diffuses, transmits, or reflects from the subject H. Each of the light is guided to the light detection unit 11.
The light detection unit 11 simultaneously receives each optical signal diffused, transmitted, or reflected from a desired site or a plurality of measured sites of the subject H whose optical axes are controlled by the irradiation / light receiving unit 9. The optical signal is converted into each detection signal which is an analog electric signal. The intensity of each light diffused, transmitted or reflected through the subject H depends on the abundance ratio or concentration of a predetermined substance existing in the subject H, for example, glucose. Therefore, the level of each detection signal output from the light detection unit 11 depends on the abundance ratio and concentration of a predetermined substance present in the subject H. The signal amplification unit 12 amplifies each detection signal output from the light detection unit 11 to a desired amplitude.

  A temperature control unit 13 and a temperature sensor 14 are provided in the apparatus housing 1. The temperature control unit 13 and the temperature sensor 14 are provided in the vicinity of the subject holding unit 5, that is, in the vicinity of a desired site or a plurality of measurement sites of the subject H. The temperature control unit 13 receives the temperature measurement signal output from the temperature sensor 14 and feedback-controls the temperature of a desired part or a plurality of measurement parts of the subject H to a predetermined temperature. The temperature control unit 13 is formed by using, for example, a metal material such as aluminum having good thermal conductivity as a thermal interface unit with the subject H, and a Peltier element serving as a heat source is attached to the bottom surface of the thermal interface unit. The temperature sensor 14 measures the temperature of one desired site or a plurality of measured sites of the subject H and outputs the temperature measurement signal. The temperature sensor 14 is composed of, for example, a thermocouple or a thermistor, and is embedded in a thermal interface unit with the subject H.

A display unit 2, an operation unit 3, a communication port 6, a data storage unit 16, a data collection unit 17, and a data processing unit 18 are connected to the control unit 15. The control unit 15 has a CPU constituting a computer, issues a display command to the display unit 2, receives an operation instruction from the operation unit 3, performs data communication with an external device through the communication port 6, Data is written to and read from the data storage unit 16, and each processing command is issued to the data collection unit 17 and the data processing unit 18.
The display unit 2 is composed of, for example, a liquid crystal display device. The display screen 2a displays, for example, a substance in the body of the subject H, for example, a measurement result R of the glucose concentration, and time information T when the substance in the subject H is measured. Display visually. The display unit 2 may include one or both of a vibration device such as an audio output device or a vibrator. The audio output device audibly notifies, for example, the measurement result of the glucose concentration in the body of the subject H. The vibration device transmits the measurement result of the glucose concentration tactilely.

  The operation unit 3 functions as an information input unit using, for example, a man-machine interface, and includes at least one of information input devices such as a keyboard, a mouse, a button, a touch key panel, or a voice guide, and a display unit. For example, life information of the subject H is input by selecting from a plurality of options displayed on the display screen 2a in an interactive manner with respect to the second display screen 2a. The life information of the subject H is, for example, at least one information of sleep information, meal information, exercise information, or medication information of the subject H. Further, the operation unit 3 inputs, for example, at least one examination information among the body temperature, blood pressure, heart rate, or blood of the subject H, or pathological information of the subject H as vital information of the subject H.

The data collection unit 17 converts each detection signal amplified to a desired amplitude by the signal amplification unit 12 into a digital signal and collects it as each measurement data.
The data processing unit 18 processes each measurement data collected by the data collection unit 17 to information on the component and concentration of the substance present in the subject H or the tissue degeneration of the subject H, for example, the subject H The glucose concentration in the body is calculated, and the glucose concentration and the like are stored in the data storage unit 16 as necessary. The data processing unit 18 includes an optimization unit 19 and a substance information calculation unit 20.
The optimization unit 19 optimizes the correlation between each measurement data collected by the data collection unit 17 and the life information of the subject H input by the operation unit 3, that is, a plurality of preset calibration models. Select an optimal calibration model from among them, or optimize the parameters of the calibration model. Further, the optimization unit 19 presets a calibration model for each of a plurality of measurement time zones, and optimizes the parameters of the calibration model according to the life information of the subject H.
The substance information calculation unit 20 calculates information on the substance and the glucose concentration in the body of the subject H using the calibration model optimized by the optimization unit 19.

The control unit 15 includes a display unit 2, a power supply unit 4, a light source unit 7, a signal amplification unit 12, a temperature control unit 13, a data storage unit 16, a data collection unit 17, data processing based on an operation signal from the operation unit 3. The operation of the unit 18 and the like is controlled. The control unit 15 supplies power to the temperature control unit 13, the data storage unit 16, the data processing unit 18, and the like as necessary. The power supply unit 4 supplies power to the display unit 2, the light source unit 7, the signal amplification unit 12, the control unit 15, and the like.
Next, the operation of the apparatus configured as described above will be described with reference to a measurement processing flowchart shown in FIG.
In step # 1 for performing noninvasive measurement, when the power button 4 is pressed, power is supplied from the power supply unit 4 to the display unit 2, the light source unit 7, the signal amplification unit 12, the control unit 15, and the like. Thereby, the control part 15 starts. Then, for example, when a finger of the subject H is held in the sensor window 5 and the operation button 3 is operated, noninvasive measurement is performed. That is, the light source unit 7 outputs monochromatic light having a desired wavelength, a plurality of monochromatic lights having different wavelengths, or light having a wavelength close to these monochromatic lights. This light enters the multiplexing unit 8 and monochromatic light of each wavelength is superimposed on the same optical axis. The light emitted from the multiplexer 8 is irradiated to a desired site or a plurality of measured sites of the subject H through the interface unit 10 by the irradiation / light receiving unit 9. At this time, each light diffused, transmitted, or reflected at a desired site or a plurality of sites to be measured of the subject H is simultaneously received by the light detection unit 11 by the irradiation / light reception unit 9, so that the optical axis of each light is Be controlled.

  The light detection unit 11 simultaneously receives each light diffused, transmitted, or reflected from a desired site or a plurality of measurement sites of the subject H whose optical axes are controlled by the irradiation / light reception unit 9 and receives these lights. Each detection signal is an analog electrical signal. At this time, the intensity of each optical signal diffused, transmitted or reflected through the subject H depends on the abundance ratio or concentration of a predetermined substance, for example, glucose present in the subject H. Therefore, the level of each detection signal output from the light detection unit 11 depends on the abundance ratio and concentration of a predetermined substance present in the subject H. The signal amplification unit 12 amplifies each detection signal output from the light detection unit 11 to a desired amplitude.

During such noninvasive measurement, the temperature control unit 13 inputs a temperature measurement signal output from the temperature sensor 14 and feedback-controls the temperature of a desired part or a plurality of parts to be measured of the subject H to a predetermined temperature. To do.
The data collection unit 17 converts each detection signal amplified to a desired amplitude by the signal amplification unit 12 into a digital signal and collects it as each measurement data Dh. The collected measurement data is stored in the data storage unit 16 together with time information Dt at the time of measurement by the control unit 15.

On the other hand, life information input is performed in step # 2 before or after the noninvasive measurement. That is, the control unit 15 displays a life information input screen on the display screen 2a of the display unit 2, and when the operation unit 3 is operated while viewing this screen, the operation input from the operation unit 3 is used as life information. The data is stored in the data storage unit 16. As the living information, at least one information of the sleep information F ₁ of the subject H shown in FIG. 4A, the meal information F ₂ shown in FIG. 4B, the exercise information F ₃ shown in FIG. 4C, or the medication information F ₄ shown in FIG. 4D. Is entered. The sleep information F ₁ , meal information F ₂ , exercise information F _3, and medication information F ₄ of the subject H have a hierarchical data structure, and are stored in, for example, the data storage unit 15. For example, the sleep information F ₁ includes data items of “time” and “sleep information”. Among these data items, “wake-up time” and “sleeping time” are included below “time”, and “sleep information” In the lower layer, there are “I was able to sleep well” and “I could not sleep well”.
FIG. 5 shows an example of a medication information F ₄ screen for inputting life information displayed on the display screen 2 a of the display unit 2. _On the screen of the medication information F ₄ , for example, input fields R ₁ , R ₂ , R ₃ for taking / administration time, each medicine, and the dosage of these medicines are displayed. As shown in FIG. 4D, the medication information F ₄ has data items of “dose / administration time” and “type”, and among these, “diabetes treatment”, “hypertension treatment”, etc. Furthermore, “insulin”, “sulphonine urea drug”, “insulin resistance improving drug” and the like are included in the lower layer of “diabetes therapeutic drug”, and “lantus” and “5 units” are included in the lower layer of “insulin”.
Thus, a plurality of choices each drug interactively of operating a keyboard of the display unit 2 of the display screen 2a is displayed on the medication information F operation unit 3 while looking at the screen _4, a mouse, a button or a touch key panel the selection, i.e. to the input field R ₂ are selected by a pull-down menu. For example, selecting "Lantus" in the input field R _2, "5 units" is displayed in the input column R _3.

When selecting the chemical interactively of operating the operating unit 3 while looking at the screen of the dosage information F _4, for example, using one or both of the vibrating device such as an audio output device or a vibrator, a question such as voice guidance or enter medication information F ₄ according to the format may be uttered vibration as prompts for medications F ₄ by the vibration device. In the case of using the voice output device, the answer may be made by voice.

Below, an example of inputting life information in a question format according to the display on the display screen 2a of the display unit 2 or a voice guide is shown. This life information is a case of measuring in the morning.
1. Start blood glucose measurement.
2. First, enter your sleep information.
3. What time did you go to bed last night? Please select from the menu.
◇ 20: 00-21: 0, 21: 00-22: 00, 22: 00-24: 00,
After 24:00,
4). What time did you get up this morning? Please select from the menu.
◇ Before 06:00, 06: 00-07: 00: 00, 07: 00-08: 00,
From 08:00 to 09:00, after 09:00,
5). Did you sleep well last night?
◇ I could sleep well, I could not sleep well.
6). Next, enter your meal information.
7). Did you eat breakfast?
◇ Yes, no,
8). What time did you eat breakfast? Please select from the menu.
◇ Before 06:00, 06: 00-06: 30, 06: 30-07: 0,
07: 00-07: 30, 07: 30-08: 00: 00, 08: 0-08: 30,
9. Please enter your meal details.
10. Please choose what you ate from the menu below.
◇ Rice, meat, fish, vegetables, dairy products, drinks, etc.
11. How many cups of rice did you eat in the bowl? Please select from the menu.
◇ 1 cup, 2 cups, 3 cups, 4 cups,
12 Then, blood glucose measurement starts, so put your finger on the sensor window 5 and press the operation button 3a.
13. Measurement is complete.
14 Your current blood glucose level is 110 mg / dL.
15. The prediction error range of this measurement result is ± 10 mg / dL.
16. The calibration model is 80% good.
17. Your current sleep state is not well reflected in the calibration model. Please check your sleep information and re-enter your blood sugar if there are any mistakes and try again.
In addition, said "13"-"17" shows an example of alerting | reporting by the audio | voice after completion | finish of measurement.
By operating the operation unit 3 in this manner, sleep information F ₁ , meal information F ₂ , exercise information F ₃ , and medication information F ₄ are input as life information of the subject H, and these life information is input by the control unit 15. For example, it is stored in the data storage unit 16.

  Furthermore, from the operation unit 3, at least one examination information among body temperature, blood pressure, heart rate or blood, or pathological information including a past condition of the subject H is input as vital information of the subject H. For example, if the subject H is diabetic, the operation unit 3 displays the blood glucose level measured by the blood test in the hospital as the vital information, glycohemoglobin (HbA1C), glycoalbumin, cholesterol, neutral fat, CRP (C reaction) Sex protein) or the like. These vital information can be used as information for optimizing the parameters of the calibration model.

Next, the optimization unit 19 uses each measurement data collected by the data collection unit 17 and life information of the subject H input by the operation unit 3 as sleep information F ₁ , meal information F ₂ , exercise information F _3. , to optimize the correlation between the dosage information F _4. That is, the optimization unit 19 performs a plurality of calibrations set in advance based on each measurement data based on non-invasive measurement and the sleep information F ₁ , meal information F ₂ , exercise information F ₃ , and medication information F _{4 of} the subject H. The optimum calibration model is selected from the calibration models, or the parameters of the calibration model are optimized.
For example, an example of the calibration model [G]
[G] = a ₀ + a ₁ · S ₁ + a ₂ · S ₂ + a ₃ · S ₃ + a ₄ · S ₄
A ₀ , a ₁ , a ₂ , a ₃ , a ₄ indicate parameters, and S ₁ , S ₂ , S ₃ , S ₄ diffuse, transmit, or reflect a plurality of measurement sites of the subject H Each measurement data detected by receiving each light is shown. Therefore, the optimization unit 19 optimizes the parameters a ₀ , a ₁ , a ₂ , a ₃ , and a ₄ . Note that there are a plurality of these parameters a ₀ , a ₁ , a ₂ , a ₃ , and a ₄ by combinations of sleep information F ₁ , meal information F ₂ , exercise information F ₃ , and medication information F ₄ of the subject H. .
Further, the optimization unit 19 includes, as each measurement data by non-invasive measurement, sleep information F ₁ of the subject H, meal information F ₂ , exercise information F ₃ , medication information F _4, and vital information of the subject H, for example. Body temperature, blood pressure, heart rate, blood, pathological information including history, and if subject H is diabetic, blood glucose level measured by hospital blood test, glycohemoglobin (HbA1C), glycoalbumin, cholesterol, neutral fat Alternatively, an optimal calibration model may be selected from a plurality of preset calibration models based on CRP (C-reactive protein) or the like, or parameters of the calibration model may be optimized.

Further, the optimization unit 19 presets a calibration model for each of a plurality of measurement time zones as shown in FIG. 6 and optimizes the parameters of the calibration model according to the life information of the subject H. The respective measurement time periods _t 0 _-t 1 in _{FIG, t 1 -t 2, ...,} t 6 each respectively for each -t ₇ calibration model _{M 1, M 2, ... M} 7 is preset. Dhb indicates blood glucose level measurement data. Optimization unit 19, the measurement time zone _{t 0 -t 1, t 1 -t} 2, ..., t 6 each respectively for each -t ₇ calibration model _{M 1,} M 2, the parameters of ... _{M 7} under You may optimize according to the living information of the sample H.

  Next, in step # 4, the substance information calculation unit 20 calculates information about the substance, for example, the glucose concentration in the body of the subject H, using the calibration model optimized by the optimization unit 19.

  Next, in step # 5, the substance information calculation unit 20 displays the calculated glucose concentration or the like on the display screen 2a of the display unit 2, and in the next step # 6, the calculated glucose concentration or the like is data as necessary. Store in the storage unit 16.

As described above, according to the first embodiment, each measurement data based on the noninvasive measurement, sleep information F ₁ as the life information of the subject H, meal information F ₂ , exercise information F ₃ , medication information F _4. The optimal calibration model is selected from a plurality of preset calibration models based on the above, or the parameters of the calibration model are optimized, so the circadian rhythm (daily rhythm) and meal intake of the subject H It is possible to calculate information on the substance in the subject with high accuracy, for example, the glucose concentration in the subject H, without being affected by fluctuation factors such as hemodynamics depending on time, sleep time, physical condition, medical condition, medication, etc. .

  In order to select the optimal calibration model or optimize the parameters of the calibration model, for example, the vital information of the subject H includes body temperature, blood pressure, heart rate, blood, pathological information including the past disease, and the subject H is diabetic. If so, blood glucose level measured by a blood test in a hospital, glycohemoglobin (HbA1C), glycoalbumin, cholesterol, neutral fat, CRP (C-reactive protein) and the like can also be used.

The input of life information of the subject H such as sleep information F ₁ , meal information F ₂ , exercise information F ₃ , medication information F _4, etc. is displayed on the display screen 2 a of the display unit 2 or dialogues such as a question format according to a voice guide Since it is performed in a format, it can be input by the subject H without a doubt.

Next, a second embodiment of the present invention will be described with reference to the drawings.
FIG. 7 shows a partial block diagram of the characteristic part of the biological information measuring device. The apparatus according to the present embodiment is substantially the same as the configuration shown in FIG. 2, and the functions of the optimization unit 19 and the substance information calculation unit 20 are different. FIG. 8 shows a measurement process flowchart, and steps # 10 and # 11 are added to the measurement process flowchart shown in FIG.
The optimization unit 19 includes a plurality of calibrations set in advance based on each measurement data based on non-invasive measurement and the sleep information F ₁ , meal information F ₂ , exercise information F ₃ , and medication information F _{4 of} the subject H. When the optimum calibration model is selected from the models or the parameters of the calibration model are optimized, the suitability of the optimized calibration model is quantitatively evaluated.
Specifically, the optimization unit 19 quantitatively evaluates the suitability of the calibration model using at least a statistical test method or a multivariate analysis method of Mahalanobis distance. That is, the calibration database 21 is connected to the control unit 15. Note that the calibration database 21 may be formed in the data storage unit 16. The calibration database 21 stores, for example, information obtained by cluster analysis of the correlation between each condition factor used for calibration model selection and calibration model parameter optimization and the calibration model. The calibration database 21 can be formed for each subject H.

  However, in step # 10 of the measurement processing flowchart shown in FIG. 8, the optimization unit 19 selects each calibration factor stored in the calibration database 21 and optimizes the parameters of the calibration model. Using the information obtained by cluster analysis of the correlation of the calibration model, the suitability of the calibration model is quantitatively evaluated using a statistical test method or a multivariate analysis method of Mahalanobis distance.

  In addition, when quantitatively evaluating the suitability of the calibration model, if there is insufficient living information necessary for selecting the calibration model, or if the suitability of the calibration model is below a desired level, optimization The unit 19 displays on the display screen 2a of the display unit 2 that the life information is insufficient, or the level of compatibility of the calibration model and the desired level or less.

  The substance information calculation unit 20 calculates a predicted measurement error of information about the substance of the subject H based on the evaluation result of the suitability of the calibration model by the optimization unit 19. Specifically, in step # 11, the substance information calculation unit 20 receives the evaluation result of the suitability of the calibration model by the optimization unit 19, and receives life information, a measurement signal, or a glucose concentration in the body of the subject H, for example. Statistics on the calculated value and information obtained by cluster analysis of correlation between each condition factor and calibration model used for selecting a calibration model stored in the calibration database 21 and optimizing the parameters of the calibration model A predicted measurement error of information related to the substance of the subject H is calculated by applying a dynamic error estimation method or the like.

  Further, in step # 6, the substance information calculation unit 20 adds the calibration model compatibility information and the predicted measurement error information to the measurement result such as the calculated value of the glucose concentration in the body of the subject H, for example. These pieces of information are stored in the calibration database 21.

  As described above, according to the second embodiment, since the suitability of the optimized calibration model is quantitatively evaluated, the evaluation result of the suitability of the calibration model and the reason thereof are shown to the subject H. Can do. Moreover, since the predicted measurement error is calculated, the measurement state and the reliability of the measurement result can be accurately shown for the subject H. Thereby, for example, measurement can be performed in a measurement time zone with a small error.

In addition, this invention is not limited to said each embodiment, You may deform | transform as follows.
For example, in each of the above-described embodiments, the case where the glucose concentration in the body of the subject H is calculated has been described. However, the present invention is not limited to this, and is present in the cells of the living tissue of the subject H or outside the living tissue. The component or concentration of a desired in-vivo substance, for example, the hemoglobin concentration in blood may be measured.
The calibration model may be changed according to the measurement time.

BRIEF DESCRIPTION OF THE DRAWINGS The external view which shows 1st Embodiment of the biological information measuring device which concerns on this invention. The block block diagram of the apparatus. The measurement process flowchart in the same apparatus. The figure which shows the sleep information of a subject among the life information operated and input in the same apparatus. The figure which shows the meal information of a subject among the life information operated and input in the same apparatus. The figure which shows the exercise | movement information of a subject among the life information operated and input in the same apparatus. The figure which shows the medication information of a subject among the life information operated and input in the same apparatus. The figure which shows an example of the screen of the medication information for life information input displayed on the display screen of the display part in the same apparatus. The figure which shows an example at the time of setting multiple calibration models for every measurement time slot | zone in the same apparatus. The partial block block diagram which shows the characteristic part of 2nd Embodiment of the biological information measuring device which concerns on this invention. The measurement process flowchart in the same apparatus.

Explanation of symbols

  1: device housing, 2: display unit, 2a: display screen, 3: operation unit, 3a: operation button, 4: power supply unit, 4a: power button, H: subject, 5: sensor window, 6: communication port , M: measurement unit, 7: light source unit, 8: multiplexing unit, 9: irradiation / light receiving unit, 10: interface unit, 11: light detection unit, 12: signal amplification unit, 13: temperature control unit, 14: temperature Sensor: 15: Control unit 16: Data storage unit 17: Data collection unit 18: Data processing unit 19: Optimization unit 20: Substance information calculation unit 21: Calibration database

Claims (16)

A measurement unit that non-invasively measures a substance in a subject;
An information input unit for inputting life information of the subject;
Parameters of the calibration model set for each of a plurality of measurement time zones based on the information on the substance measured by the measurement unit and the life information input from the information input unit , according to the life information An optimization unit to optimize,
A substance information calculation unit for calculating information on the substance based on the parameters of the calibration model optimized by the optimization unit;
A biological information measuring device comprising: The biological information measuring apparatus according to claim 1, wherein the measurement unit measures the substance in the subject and acquires time information when the substance is measured. The biological information measuring apparatus according to claim 1, wherein the information input unit inputs at least one of sleep information, meal information, exercise information, and medication information of the subject as the life information. The biological information measuring apparatus according to claim 1, wherein the information input unit includes at least a display, and inputs the life information in an interactive manner with respect to a display screen of the display. The biological information measuring apparatus according to claim 4, wherein the information input unit inputs the life information by uttering a voice guide. The information input unit, the biological information measuring apparatus according to claim 1, wherein the selected one of a plurality of options to enter the living information. The biological information measuring apparatus according to claim 1, wherein the information input unit inputs vital information of the subject. The information input unit, the body temperature of the subject as the vital information, the blood pressure, at least one inspection information of the heart rate or blood, or the following claims 1, wherein the inputting the pathological condition information of the subject Biological information measuring device. Wherein the optimization unit is optimized the calibration from a plurality of the calibration model which has been set in advance based on said life information entered said material information measured by the measuring unit from the information input unit select the model, or the biological information measuring apparatus according to claim 1, wherein the optimizing the parameters of the calibration model. Wherein the optimization unit is configured optimized biological information measuring apparatus according to claim 1, wherein the quantitatively evaluating the suitability of the calibration model. The optimization unit may, at least statistical test method or multivariate analysis information measuring apparatus according to claim 1, wherein the quantitatively evaluating the suitability of the calibration model using. The material information calculation unit, the biological according to claim 1, wherein the calculating the expected measurement error of the information on the substance on the basis of the compatibility of the evaluation result of the calibration model by the optimizing unit Information measuring device. The biological information measurement apparatus according to claim 1, wherein the substance information calculation unit calculates a concentration of a body fluid component in a cell of the biological tissue of the subject or the extracellular material of the biological tissue . The biological information measurement apparatus according to claim 1, wherein the substance information calculation unit calculates a glucose concentration as the concentration of the body fluid component . Non-invasive measurement of substance information in the subject by the measurement unit,
Input the life information of the subject through the operation unit,
Parameters of the calibration model set for each of a plurality of measurement time zones based on the information of the measured substance and the life information input through the operation unit by the processing of the computer, the life information Optimized according to
Calculating information on the substance according to the parameters of the optimized calibration model;
BIOLOGICAL information measuring how to characterized in that. The biological information measuring method according to claim 15 , wherein the life information of the subject is input via the operation unit before or after the measurement of the substance information in the subject by the measuring unit .

Images