WO2020017028A1 - 非破壊検査装置 - Google Patents

非破壊検査装置 Download PDF

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Publication number
WO2020017028A1
WO2020017028A1 PCT/JP2018/027299 JP2018027299W WO2020017028A1 WO 2020017028 A1 WO2020017028 A1 WO 2020017028A1 JP 2018027299 W JP2018027299 W JP 2018027299W WO 2020017028 A1 WO2020017028 A1 WO 2020017028A1
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measurement
light
measured
value
substance
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PCT/JP2018/027299
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English (en)
French (fr)
Japanese (ja)
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木暮一也
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桐生電子開発合同会社
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Priority to PCT/JP2018/027299 priority Critical patent/WO2020017028A1/ja
Priority to CN201880095412.4A priority patent/CN112351735B/zh
Publication of WO2020017028A1 publication Critical patent/WO2020017028A1/ja

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters

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  • the present invention relates to a nondestructive measuring device for measuring, calculating and displaying a relative change amount of a rise and fall amount and a temporal differential value of a change amount from a time when a substance to be measured is a non-destructive reference.
  • One of the non-destructive means for measurement is a light measurement method such as spectroscopic analysis.
  • One of the indications is a non-invasive blood glucose measurement technique. This is to identify the blood glucose level by the amount of change in physical properties such as light absorbance and polarization, depending on the concentration of the blood glucose level.
  • a plurality of methods based on near-infrared spectroscopy as shown in FIG. 1 have been reported in the past. This method measures the mass (concentration) of a substance to be measured based on the intensity distribution of the spectral spectrum.
  • this analysis method is generally applied under specific conditions, and when applied to a plurality of unspecified samples, there is a very difficult problem. That is, the components other than the substance to be measured differ from individual to individual. It is almost impossible to adapt and use the measurement widely due to physical variation and individual differences.
  • the method based on the spectroscopic analysis is basically a method for measuring the absorbance of light, but the same can be said for other methods using polarized light. After all, if the problems in the case of measuring a substance which changes with time by light with time are determined and sorted out, it will result in the problems of reproducibility and measurement accuracy due to generation of a calibration curve, physical variation and the like. It is difficult to realize a destructible measurement device that measures the amount of a substance that changes with time by light with time.
  • Patent No. 3692751 2003 Application of infrared spectroscopy to noninvasive blood component measurement, IEEJ Trans. EIS. Vol. 127, No. 5, 686-691 (2007). (Shinshu University)
  • the problem to be solved is that, although it is understood that the measured value changes with time due to light, the mass (concentration) of the substance to be measured is measured because the accuracy of the calibration curve and the measurement accuracy are reduced due to physical variation.
  • the mass (concentration) of the substance to be measured is measured because the accuracy of the calibration curve and the measurement accuracy are reduced due to physical variation.
  • the present invention changes the way of thinking about the measurement of a substance by light, does not create a calibration curve, and measures and calculates the relative change and the temporal change of the substance to be measured from a certain time to a certain time.
  • the main feature is a method of using the light emitting portion as an action point for applying pressure to a measurement site, and adjusting the optical axis for measurement in real time to perform measurement.
  • the destructive measuring device of the present invention does not directly measure the amount (concentration) of the substance to be measured, it can perform destructive measurement using light with good reproducibility as an index instead of the mass (concentration) of the substance to be measured. become.
  • non-invasive in measuring blood glucose levels using light.
  • identification is based on light absorbance and diffusion degree.
  • PD Photo Device
  • the degree of diffusion is proportional to the blood glucose concentration, so a Photo Device (hereinafter referred to as PD) is used to measure the amount of light.
  • the sensitivity is Differently, the size is equal to or larger than the light diameter of the light to be used (the size is determined from the range of the assumed diffusion degree).
  • the amount of light detected by the PD is reduced by absorption by blood sugar, and at the same time, is diffused by tissue (diffuser) and blood sugar.
  • the amount of light detected by the PD expands the absorbance by the degree of diffusion, and the amount measured by the PD increases the sensitivity of detecting a change in blood glucose level.
  • the measured value obtained by superimposing the absorbance and the diffusivity is used as a basic detection amount.
  • the absorbance is determined from the detected amount.
  • the temperature of the measurement site is measured and corrected by the temperature value to obtain the final light absorption.
  • Blood sugar is one of blood components, but there are a plurality of substances other than blood sugar that have light absorption properties near a wavelength called near infrared. If you eat a meal, your blood level will rise about 20 to 40 minutes after the meal for a certain period of time, usually as a response change of the human body, and about 2 hours after the meal due to the action of insulin etc., about the same as before the meal It is estimated that only blood glucose and water are the only components that change rapidly in the blood due to this eating action. The reason is that substances other than blood sugar level are components generated from each organ or components generated by reaction, and it is very slow compared to changes in blood sugar level before appearing as changes in blood components It is.
  • a factor in which the absorbance and the diffusivity change in a short time of about 2 hours can be almost identified as a blood glucose level. It is possible to separate blood by measuring the absorbance of a light source at a wavelength different from the absorption spectrum wavelength of blood glucose. In other words, it indicates that the change amount of the blood sugar level can be corrected based on the absorbance sensitivity characteristic due to the moisture and the difference in the blood sugar level absorbance. However, it is necessary that the two light sources be observed coaxially. Originally, a blood glucose level cannot be identified unless a calibration curve based on a large amount of data is created for identification of non-blood glucose.However, a calibration curve is not required for such a change in blood glucose level. become.
  • the present apparatus is basically characterized in that the amount of increase or decrease in blood sugar level is measured. Further, when measuring the amount of increase or decrease in blood sugar level as in this measurement, errors due to individual variations such as skin pigments and skin conditions can be offset, so that measurement accuracy and reproducibility can be improved.
  • FIG. 2 shows a general example of a temporal change of the blood sugar level.
  • the measurement of a blood sugar level performed in a health check or the like is a so-called fasting blood sugar level. Even if the value is measured somewhat high, it is possible to overlook the severity.
  • the response called “hidden diabetes” is also a rapid rise in blood glucose level after eating, and this time differential value can detect this symptom.
  • the optical path length In the case of measurement using light, a change in the optical path length causes an error and a reduction in accuracy. Therefore, the optical path length must be constrained at a fixed position so as not to change, which is extremely inconvenient. Considering convenience, the method of measuring with reflected light is excellent, but if the part to which light is actually applied changes, the subcutaneous tissue at the measurement part may change, With a decrease in In addition, accuracy is also reduced by the light incident state, vibration, and the like. Therefore, as a structure of the measuring device, first, a structure for limiting a part to be measured is adopted. This is, for example, a structure of being sandwiched between ear tabs and fingers (FIG. 6). In this case, the measurement is performed at a substantially constant site. Also, the ear tabs and the area between the fingers may be less susceptible to the change in pigment. In addition, it is known that the absorbance changes when the temperature changes, and it can be expected that a portion that can be sandwiched does not involve a large temperature change
  • the sandwiching structure allows the optical path length to be kept constant, and also allows a constant pressure to be applied to the measurement site, which can suppress changes in blood flow. Become. When measuring by light, the most influential thing is hemoglobin of blood, and a change in this decreases measurement accuracy. In particular, the change in blood flow is large, such as after a meal. Even if the part to be measured is limited to some extent, blood vessels are present in the subcutaneous tissue, and if blood vessels on the optical path are included, accuracy is expected to decrease. Therefore, using a Actuator (same structure as an optical pickup such as a CD or DVD, etc., not shown) to reduce the light beam, provide a mechanism to adjust the irradiation position at the site and to adjust the detection light to the maximum. .
  • a Actuator similar structure as an optical pickup such as a CD or DVD, etc., not shown
  • FIG. 3 is a diagram for explaining measurement by moving the Actuator.
  • the blood glucose level is corrected by a light source that is arranged coaxially with the beam that measures the blood glucose level and has the same optical path and has a different wavelength, and at the same time, corrects the physical variation and correction. Physical variation is possible because it is considered to vary in the same way as variation in wavelength by measuring blood glucose levels.
  • FIG. 4 shows an optical basic configuration.
  • a near-infrared light source (a semiconductor laser diode is used in this configuration) uses a plurality of different wavelengths, and the plurality of light sources are emitted coaxially.
  • a wavelength a light source exhibiting large absorption in Glucose, for example, a light source near 1500 nm (measurement light: 23a), a second wavelength light source (hereinafter, LD2) and a 1300 nm light source (reference light: 23b), a first wavelength light source (hereinafter, LD1) Use Laser light is desirable as the light source. The reason is that the emission wavelength range is very narrow and can be treated as a single wavelength.
  • a light source having a light emission characteristic with a deviation of about 10 nm as a range considered as a single wavelength may be used.
  • the reason for choosing a wavelength around 1300 nm is that, while showing high absorbance for moisture, Glucose is a light source with a wavelength that does not show large absorption, and combining that light source, from the change in the absorbance,
  • the detection amount is corrected by the measurement light as the change amount of the water content and the physical change amount.
  • This correction method may be a method of obtaining a difference or a method of obtaining a ratio.
  • FIG. 4 shows a configuration in which transmitted light is used for a measurement site
  • FIG. 5 shows a configuration for detecting diffuse reflection light. Both configurations are detected in a state where irradiated light passes through the inside of the measurement site.
  • the light from the light sources (23a, 23b) is condensed to a small beam by the lenses (24a, 24b) to become collimation light (14).
  • the reason for narrowing the beam to a small diameter is that it is possible to secure the brightness without using a light source with a large output, to reduce the power consumption and to suppress the cost. This is because it can be avoided when there is a blood vessel (13) .
  • Beam becomes coaxial light by PBS (25a, 25b) etc.
  • two light sources emit light at the same time.
  • FIG. 6 shows the structure, and incorporates the structure of the optical structure shown in FIGS.
  • the light from the light source (14) is guided by the mirror (29) in the housing (27).
  • a configuration in which the light is guided to Actuator Lens by a fiber or the like is also possible (not shown).
  • FIG. 6 shows the configuration of transmitted light, but the same mechanism is used for diffuse reflection, and the optical structure shown in FIG. 5 is incorporated.
  • the converging objective lens (20b) arranged on the PD side in the structure using transmitted light becomes the measured object support component (26).
  • FIG. 7 is a basic electric circuit block diagram. Although FIG. 7 shows a configuration using transmitted light, the same configuration is used in an electric circuit when diffuse reflection light is used.
  • OSC1 (30a) (not shown) is a signal used for measurement, for example, a signal for AC-modulating the optical output at 1 Khz. The measured value is the amplitude at which the signal obtained by absorbing and diffusing the signal by the OSC1 (30a) by the measurement site is detected by the PD (17).
  • OSC2 (30b) switches between light source 1 (23a) (hereinafter LD1) and light source 2 (23b) (hereinafter LD2). When LD1 emits light, LD2 stops, and when LD2 emits light, LD1 stops.
  • the light emission is alternately switched by the light source changeover switch circuit (31) as described above.
  • OSC2 (30b) when the output of OSC2 (30b) is H, LD1 emits light, and when it is L, LD2 emits light.
  • LD1 is the reference light
  • LD2 is the measurement light.
  • the output of the PD (17) (shared with the reference light and the measurement light) is IV-converted (35) and amplified by the synchronous AMP (36).
  • the light source drive circuits 1 and 2 (hereinafter LDD 1 and 2) (32a and 32b) have a high-frequency superimposing function (34) on the laser diode, and in order to avoid instability of laser emission due to reflected light, switch from single mode to multi
  • the optical output is kept constant by an APC circuit (not shown) such as Front Monitor and Back Monitor Diode used in -Mode oscillation.
  • a temperature sensor (34) is arranged to correct for changes due to temperature.
  • the RMS circuit (37) outputs the effective value of the detected signal and inputs it to Servo @ AMP (38, 40).
  • the LD1 Servo AMP (38) calculates and obtains the input amount of LDD1 (32a). If this output is large, it indicates that the amount of light attenuation in the DUT (21) is large. This is the reference value for LD2. This reference value means that the optical power necessary for basically measuring the object under measurement (21) is automatically obtained.
  • the detected amount of LD1 as a reference of the LD2 measurement light is equivalent to correcting the physical displacement of the measured object (21) and the displacement of the water content. Since the physical displacement (systematic variation of the DUT (21)) is considered to have the same attenuation characteristics (does not affect the light absorption characteristics and diffusivity characteristics) for both LD1 and LD2, the amount detected by LD1 is physical. This reflects the amount of displacement and the amount of correction of the absorbance due to moisture that may vary with time.
  • the difference between the output of the circuit (41c) that holds the output of the RMS circuit (37) when the LD2 emits light and the output value of the circuit (41a) that holds the control amount of the LD1 is calculated, and the control of the LD2 is performed.
  • the output of LD2 can be kept constant.
  • the output of the measurement value correction circuit (42) that calculates the difference between the two is finally a measurement value obtained by correcting the physical displacement and the water displacement from the LD2 detection amount.
  • the measurement is performed three times with a time lag. A method of obtaining a final result by these three measurements will be described later.
  • Actuator @ Lens (22) adjusts according to the light emission period (49) of LD1.
  • the difference between the outputs (17s, 17b) of the Side SUB-PDs of the Main @ PD (17) is calculated (43), and it is possible to detect which side the Beam center is on. Accordingly, the center of the intensity of light detected by the PD becomes the center of the PD.
  • the light intensity distribution detection circuit produces an output on the (+) side from the reference voltage, and the Shift Drive circuit (44b) is driven in a direction in which this output becomes smaller.
  • the control output of the reference light by the LD1 is measured a plurality of times using the LD1 emission period (49) before starting the measurement, and the Tilt Drive reference voltage generation circuit (46) is used each time.
  • the Tilt Drive reference voltage generation circuit (46) is used each time.
  • the new Tilt-Drive mechanism (48) and Shift-Drive mechanism (47) provide real-time adjustments to eliminate the influence of the tissue structure of the measurement site and to correct for deviations due to vibration and the like.
  • the configuration of an analog Servo-Loop is shown as an electric circuit, but it is naturally possible to realize the digital circuit by using an MPU (52) or the like.
  • the light emission of LD1 and LD2 is considered to emit light with a waveform (30c) from the oscillator as shown in FIG. 9, but this light emission is considered to be a short pulse light emission (30d), for example, 10 ns or less.
  • This can be realized by performing pulse emission of about 30 ns, and this pulse emission also makes it possible to avoid a rise in the temperature of the measurement site due to light energy. By suppressing the temperature rise, improvement in measurement accuracy can be expected.
  • the safety zone for the human body with respect to the light intensity is determined based on internationally standardized safety standards.
  • the synchronous AMP (36) is also realized by digital signal processing.
  • the control amount of LD1 and LD2 of Servo Loop itself becomes a detection amount corresponding to the absorbance and the diffusion degree as a result.
  • FIG. 9 shows a configuration diagram in that case.
  • the value (36a) at the time of light emission of LD1 (light emission control amount is a predetermined amount) is input to AD several times, and the drive amount of the Tilt drive circuit (45b) is changed so that the detection amount of LD1 is minimized.
  • the signal (35s, 35b) from the Sub-PD is AD-input to the MPU (52) for adjustment by the Shift-Drive mechanism (47) with the optimal drive amount detected and determined as the optimal state of Tilt.
  • calculation operation corresponding to the light intensity distribution detection circuit (43) is performed in the MPU (52) so as to be at the center of Beam, and the Shift ⁇ ⁇ Drive circuit (44b) is driven.
  • This series of Tilt control and Shift control are performed before the measurement by LD1 and LD2.
  • LD1PUON / OFF signal (32d) and LD2ON / OFF signal (32e) drive LD1 and LD2 from MPU (52), but correspond to modulation by OSC1 (30a).
  • the output from the MPU is adjusted by a certain amount in the LD1 emission control amount (32c), and the value input from the AD (36a) becomes a predetermined value (corresponding to the LD1 reference voltage generation circuit (39)).
  • the detection amount is determined so as to be the detection value of LD1.
  • the LD2 emission control amount (32f) is adjusted so that the value input (36a) to the MPU by the AD becomes a constant amount based on the amount detected by the LD1.
  • the LD2 emission control amount (32f) is a detection amount by LD2.
  • the detection amount of LD1 is subtracted from the detection amount of LD2 by the MPU (52), and corrected by the signal (33a) from the temperature correction sensor (33).
  • the correction amount is based on the value obtained from the absorbance characteristics with temperature.
  • (Determined experimentally) is the final measured value. With this configuration, it is assumed that the measured blood sugar level is in the range of 50 mg / dl to 200 mg / dl.
  • SMBG actually used for the treatment of diabetes requires a range of about 0 mg / dl to 900 mg / dl. If this Range is assumed, a considerably large Laser output may be required, but by reducing the Range, low power consumption and Cost Down can be realized.
  • the pre-meal operation switch (54a) is operated to measure the pre-meal value.
  • the measured value at this time is (t1, S1).
  • the post-meal operation switch (54b) is operated to perform measurement.
  • the measured value at this time is (t2, S2).
  • the after-meal operation switch is operated to perform measurement.
  • the measured value at this time is (t3, S3).
  • This increased blood sugar level is called a blood sugar spike, and the fact that the value of this spike is large is also called so-called hidden diabetes. If the current time derivative is large, it is estimated that there is a large blood glucose spike.
  • the measurement is equivalent to the measurement of the blood glucose spike even if the measurement is not performed continuously. Also.
  • the difference between the measured values and the rate of change are completed and calculated within a short period of time, so that the deviation from the accuracy is canceled out, and the measurement accuracy and reproducibility are improved.
  • Graph in FIG. 10 is a graph for obtaining a final judgment value.
  • the horizontal axis represents the value of ds (56), and the vertical axis represents the final measurement result dds (57).
  • a plurality of curves in this space correspond to dts (58).
  • the ds, dts, and dds characteristics indicate that dds (57) increases when the dts (57) value is high even when the ds (56) value is low.
  • Which dts (58) curve is selected is selected, for example, by a value obtained by normalizing the dts value to about 20. (How to draw this dts curve is determined as a product specification based on medical test standards for actual blood glucose levels.)
  • the measured value may be abnormal or may be an abnormal measurement result.
  • the dds (57) value is displayed on the display (53) and flashes at the same time, indicating that the measured value result needs attention.
  • glucose metabolism is abnormal (severe)
  • the ds value may be small.
  • the dts value can be small. This state corresponds to a case where the blood sugar level is extremely high before the meal and the blood sugar level does not rise further by the meal.
  • the setting of the area shown in (59) assumes breakfast, lunch, and dinner, and prepares three types of graphs, and selects which graph is selected depending on the time zone of the measurement. For example, if the clock (55) is in the morning, it is possible that a considerable amount of time has passed since the previous day's meal, and in this case, the blood sugar level may have dropped accordingly.
  • Use the Graph that works from time to time.
  • this measurement device does not display a numerical value.
  • Use Color Gradation instead. For example, “blue” is set based on the case where the dds value is 0, and the numerical value vs. Color is mapped (60) so that the maximum value is set to “red”, for example.
  • It can be used as an index for the purpose of new health management instead of blood sugar level, and can be applied as a diagnostic device for early detection of so-called hidden diabetes, which has not been able to measure and detect fasting blood sugar level until now.
  • a method of measuring the state of change for example, by measuring a change in sugars generated by photosynthesis of a plant, the method can be applied to an agricultural control device.

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PCT/JP2018/027299 2018-07-20 2018-07-20 非破壊検査装置 WO2020017028A1 (ja)

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