WO2013146243A1 - Dispositif de détection et procédé de détection - Google Patents

Dispositif de détection et procédé de détection Download PDF

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Publication number
WO2013146243A1
WO2013146243A1 PCT/JP2013/056928 JP2013056928W WO2013146243A1 WO 2013146243 A1 WO2013146243 A1 WO 2013146243A1 JP 2013056928 W JP2013056928 W JP 2013056928W WO 2013146243 A1 WO2013146243 A1 WO 2013146243A1
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concentration
zone
sampling interval
analyte
unit
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PCT/JP2013/056928
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English (en)
Japanese (ja)
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松本淳
深井利夫
大澤孝明
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テルモ株式会社
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Priority to JP2014507634A priority Critical patent/JP6109812B2/ja
Publication of WO2013146243A1 publication Critical patent/WO2013146243A1/fr

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/645—Specially adapted constructive features of fluorimeters

Definitions

  • the present invention relates to a sensing device and a sensing method for quantifying an analyte concentration intermittently or continuously.
  • a sensing device for quantifying the concentration of the analyte has been developed by utilizing the property that the fluorescence intensity changes due to the interaction between the analyte and the labeled compound.
  • an apparatus has been proposed in which a sensor unit is embedded in the body of a subject and glucose concentration can be continuously quantified (see Japanese Patent Nos. 4593957 and 4558448).
  • Japanese Patent No. 4593957 and Japanese Patent No. 4558448 aims to reduce power consumption by improving the structure of the apparatus. For example, the sampling interval for quantification is appropriately set. By determining, there is enough room for further reducing power consumption.
  • the present invention has been made to solve the above-described problems, and an object of the present invention is to provide a sensing device and a sensing method capable of reducing power consumption during intermittent quantification using a sensor.
  • the sensing device is a device for intermittently or continuously quantifying the concentration of an analyte, the sensor unit acquiring a measurement signal correlated with the concentration of the analyte according to a fixed sampling interval, and the sensor A concentration quantification unit that quantifies the concentration of the analyte based on the measurement signal acquired by a unit, a zone classification unit that classifies a predetermined concentration range into a plurality of zones, and the analyte quantified by the concentration quantification unit.
  • An interval determining unit that determines the sampling interval according to whether or not the plurality of zones classified by the zone classifying unit with respect to the density of light is included.
  • the sampling interval according to the categorization of the plurality of zones classified by the zone classification unit with respect to the zone classification unit for classifying the predetermined concentration range into a plurality of zones and the quantified analyte concentration Since the interval determining unit for determining the difference is provided, the change in the concentration of the analyte can be grasped globally depending on whether the zone belongs or not, and timely quantification without excess or deficiency becomes possible.
  • the sensor unit includes an optical sensor that acquires the measurement signal from a light phenomenon generated by applying energy to a labeling substance or a subject.
  • quantitative_assay using an optical sensor can be reduced.
  • the optical sensor includes an excitation light source that emits excitation light that promotes the generation of fluorescence toward the labeling substance, and the excitation light is emitted according to the sampling interval determined by the interval determination unit. It is preferable to further include a light source control unit that controls the excitation light source.
  • reducing the quantitative frequency greatly contributes to reduction of power consumption, and thus is particularly effective. It also has an effect of suppressing the deterioration of the fluorescent dye.
  • the zone classification unit is configured to set the predetermined density range to a highest density zone existing on the highest density side, a lowest density zone existing on the lowest density side, and at least one intermediate density existing on the intermediate density side. It is preferable to classify into zones.
  • the interval determination unit determines the sampling interval in the highest concentration zone so as to be smaller than any of the sampling intervals corresponding to the at least one intermediate concentration zone.
  • the interval determination unit determines the sampling interval in the lowest concentration zone so as to be smaller than any of the sampling intervals corresponding to the at least one intermediate concentration zone.
  • the interval determination unit further determines the sampling interval in accordance with a trend of the concentration of the analyte obtained by the last quantitative determination. By considering trends together, it becomes possible to capture changes in concentration from different viewpoints, which is more effective.
  • the interval determination unit performs the sampling according to the case where the trend is in the falling state. It is preferable to determine the sampling interval so as to be smaller than the interval.
  • the interval determination unit performs the sampling according to the case in which the trend is in an ascending state. It is preferable to determine the sampling interval so as to be smaller than the interval.
  • a setting unit for collectively setting the sampling interval data set corresponding to each of the zones, which is used for determination by the interval determination unit.
  • a setting unit that collectively sets the sampling interval data set corresponding to the combination of each zone and each trend, which is used for determination by the interval determination unit.
  • a sensing method is a method using a sensing device that quantifies analyte concentration intermittently or continuously, a classification step for classifying a predetermined concentration range into a plurality of zones, and the sensing device includes: An acquisition step of acquiring a measurement signal correlated with the concentration of the analyte according to a fixed sampling interval using a sensor unit comprising, a determination step of quantifying the concentration of the analyte based on the acquired measurement signal, A determination step of determining the sampling interval according to the categorization of the plurality of classified zones with respect to the quantified concentration of the analyte.
  • the sensor unit includes an optical sensor that acquires the measurement signal from a light phenomenon generated by applying energy to a labeling substance or a subject, and the acquisition step acquires the measurement signal using the optical sensor. It is preferable to do.
  • the optical sensor further includes an excitation light source that emits excitation light that promotes the generation of fluorescence toward the labeling substance, and controls the excitation light source to emit the excitation light according to the determined sampling interval. It is preferable to further comprise a control step.
  • the predetermined concentration range is divided into a highest concentration zone existing on the highest concentration side, a lowest concentration zone existing on the lowest concentration side, and at least one intermediate concentration zone existing on the intermediate concentration side. It is preferable to classify into.
  • the sampling interval in the highest concentration zone is determined so as to be smaller than any of the sampling intervals corresponding to the at least one intermediate concentration zone.
  • the sampling interval in the lowest concentration zone is determined so as to be smaller than any of the sampling intervals corresponding to the at least one intermediate concentration zone.
  • the sampling interval is determined in accordance with a trend of the concentration of the analyte obtained by the most recent quantitative determination.
  • the determination step includes the sampling interval corresponding to the case in which the trend is in a down state. It is preferable to determine the sampling interval so as to be smaller.
  • the determination step includes the sampling interval corresponding to the case where the trend is in an rising state. It is preferable to determine the sampling interval so as to be smaller.
  • the method further includes a setting step for collectively setting data sets of the sampling intervals corresponding to the zones, which are used for the determination in the determination step.
  • the method further includes a setting step for collectively setting a data set of the sampling interval corresponding to a combination of each zone and each trend, which is used for the determination in the determination step.
  • the predetermined concentration range is classified into a plurality of zones, and the sampling interval is determined according to the affiliation of the plurality of zones with respect to the quantified analyte concentration. Therefore, it is possible to grasp the change in the concentration of the analyte globally depending on whether the zone belongs or not, and timely quantification without excess or deficiency becomes possible.
  • FIG. 8A is a schematic explanatory diagram illustrating an example of determining whether a zone belongs or not.
  • 8B is a schematic explanatory diagram illustrating an example of estimating a trend from a plurality of quantitative values.
  • 9A and 9B are front views of the display device in a state where quantitative visible information is displayed. It is a graph showing the time-dependent change of the blood glucose level obtained by quantifying the blood glucose concentration according to the determination method shown in FIG. It is a 2nd table
  • the sensing device 10 includes a sensor unit 12 (including a fluorescence sensor 14 and a temperature sensor 15), a sensor control circuit 16, a calculation unit 18, a power supply circuit 20, a ROM 22, and a RAM 24.
  • the clock generator 26, the input unit 27, and the display 28 are basically provided.
  • the fluorescence sensor 14 acquires a measurement signal (hereinafter referred to as a fluorescence signal) corresponding to the intensity of the fluorescence F due to the interaction between the analyte A and the labeled compound.
  • the fluorescence F may be light resulting from the binding or dissociation between the analyte A and the labeling compound, or may be light resulting from the binding or dissociation between the third component different from the analyte A and the labeling compound.
  • the concentration of analyte A can be quantified based on the fluorescence signal.
  • the temperature sensor 15 acquires a signal corresponding to the environmental temperature in the vicinity of the fluorescent sensor 14 (hereinafter referred to as a temperature signal).
  • the sensor unit 12 is not limited to the above-described form, and a measurement signal correlated with the concentration of the analyte A from a phenomenon (for example, a light phenomenon) generated by applying energy to the labeling substance or the subject. It only needs to be acquired.
  • a phenomenon for example, a light phenomenon
  • an optical sensor that measures absorbance, Raman scattered light intensity, or the like, or a chemical sensor that measures temperature, electrical resistance, or the like may be used.
  • the sensor control circuit 16 drives the fluorescence sensor 14 and the temperature sensor 15, and controls the fluorescence signal and the temperature signal so as to be acquired.
  • the calculation unit 18 is composed of a CPU, an MPU, and the like, reads a program recorded in the ROM 22 and executes various signal processing described later.
  • the power supply circuit 20 supplies power to each component in the sensing device 10 including the calculation unit 18.
  • the RAM 24 can read or write various data necessary for carrying out the sensing method according to the present invention in addition to the fluorescence signal input via the fluorescence sensor 14 and the temperature signal input via the temperature sensor 15. is there.
  • the clock generator 26 generates a clock signal at a predetermined cycle and supplies it to the calculation unit 18 side. Thereby, the calculating part 18 can control the acquisition timing of a fluorescence signal and a temperature signal.
  • the input unit 27 is provided so as to be able to input various information (for example, measurement mode setting parameters) used for the calculation in the calculation unit 18.
  • various information for example, measurement mode setting parameters
  • a push button may be used, or a touch panel incorporated in the display device 28 may be used.
  • the display 28 visualizes and displays various information related to the concentration of the analyte A quantified by the calculation unit 18.
  • the display 28 is a display module capable of monochrome or color display, and may be composed of a liquid crystal panel, an organic EL (Electro-Luminescence), an inorganic EL panel, or the like.
  • the sensor unit 12 includes a substantially rectangular casing 30.
  • the inside of the housing 30 is hollow, and can accommodate the fluorescent sensor 14, the base material 32, and the six metal wires 34, 35, 36.
  • the housing 30 and the base material 32 are each formed of a resin such as polyimide, parylene (polyparaxylylene), or cyclic polyolefin. Further, in order to block external light, the material may contain a light blocking material such as carbon black.
  • one surface (entrance surface 38) of the housing 30 is made of hydrogel, carbon black, and the like, and has characteristics of allowing the analyte A to pass and blocking external light.
  • the fluorescent sensor 14 includes, in order from the bottom to the top, a substrate 40 made of silicon or the like, a photodiode (Photo Diode: hereinafter referred to as “PD”) element 42, a first protective film (not shown), a filter 44, and light emission. It comprises a diode (Light Emitting Diode: hereinafter also referred to as “LED”) element 46 (excitation light source), a second protective film 48 made of epoxy resin or the like, and an indicator layer 50.
  • a PD element 42 is formed on the surface of the substrate 40.
  • the PD element 42 is a photoelectric conversion element that converts the fluorescence F into an electrical signal.
  • various photoelectric conversion elements such as a photoconductor (photoconductor) or a phototransistor (Phototransistor, PT) may be used.
  • the PD element 42 and the metal wire 34 are electrically connected by means such as a bonding wire 52 or a through wiring.
  • the filter 44 is an absorptive optical filter that blocks the wavelength band of the excitation light E emitted from the LED element 46 and passes the fluorescence F on the longer wavelength side than the wavelength band.
  • a silicon film such as polycrystalline silicon, a silicon carbide film, or a gallium phosphide film may be used.
  • the LED element 46 is a light emitting element that emits excitation light E that promotes generation of fluorescence F.
  • various types of light emitting elements such as an organic EL element, an inorganic EL element, or a laser diode element may be used.
  • the indicator layer 50 emits fluorescence F corresponding to the concentration of analyte A (for example, glucose) that has entered from the entry surface 38.
  • the indicator layer 50 is made of a base material containing a fluorescent dye as a labeling compound.
  • a labeled compound for example, a substance that reversibly binds to analyte A such as a ruthenium organic complex, a phenylboronic acid derivative, or a fluorescein-labeled dextran as a fluorescent dye
  • a third component for example, rhodamine-labeled concanavalin A.
  • a third component may be included in the base material of the indicator layer 50 together with the labeling compound. Alternatively, another mechanism for mixing the third component may be provided.
  • a temperature sensor 15 capable of acquiring a temperature signal in the vicinity of the fluorescence sensor 14 is also arranged inside the housing 30.
  • an optical type such as a fluorescence thermometer, a thermistor type, a metal thin film resistance type, or a semiconductor type based on the temperature characteristics of the forward current of the PN junction may be used.
  • a semiconductor type sensor it can be formed on the substrate 40 like the PD element 42.
  • the metal wires 34, 35, and 36 are formed of a conductor such as gold, aluminum, or copper, and have a function of increasing rigidity in addition to a role as electric wiring in the housing 30.
  • the sensor unit 12 is electrically connected to the sensor control circuit 16 (see FIG. 1) via metal wires 34-36.
  • the metal wire 34 includes two metal wires 34a and 34b.
  • the metal wire 35 is composed of two metal wires 35a and 35b.
  • the metal wire 36 is composed of two metal wires 36a and 36b. For example, by providing an insulating layer (not shown) between the metal wire 34 (or the metal wire 35) and the metal wire 36, the two may be electrically insulated.
  • the sensor control circuit 16 can acquire the fluorescence signal from the PD element 42 via the metal wire 34. Further, the sensor control circuit 16 can supply driving power to the LED element 46 via the metal wire 35. Furthermore, the sensor control circuit 16 can acquire the temperature signal from the temperature sensor 15 via the metal wire 36.
  • the concentration of the analyte A in the body of the subject can be continuously measured by causing the subject to puncture and hold the needle tip. At that time, a part of the analyte A enters the inside of the housing 30 from the entry surface 38 and stays around the indicator layer 50.
  • the sensor control circuit 16 supplies a drive power signal to the LED element 46 through the metal wire 35 of the fluorescent sensor 14, whereby the excitation light E is emitted. Then, the excitation light E from the LED element 46 is incident on the indicator layer 50.
  • the indicator layer 50 emits fluorescence F having an intensity corresponding to the concentration of the analyte A by the interaction between the analyte A and the labeling compound or by the interaction with the addition of the third component.
  • Fluorescence F from the indicator layer 50 is transmitted through the LED element 46, the filter 44, etc., and then photoelectrically converted by the PD element 42, transmitted through the metal wire 34 as a fluorescence signal, and supplied to the sensor control circuit 16 side.
  • a temperature signal from the temperature sensor 15 is transmitted through the metal wire 36 and supplied to the sensor control circuit 16 side.
  • the fluorescence sensor 14 acquires a fluorescence signal
  • the temperature sensor 15 acquires a temperature signal. 2 and 3 can be applied to various uses such as an enzyme sensor, a glucose sensor, a pH sensor, an immune sensor, or a microorganism sensor.
  • the structure of the sensor part 12 can take various structures, without being restricted to this structure.
  • the sensor control circuit 16 and the arithmetic unit 18 that are physically separated are provided so as to be able to communicate with each other wirelessly, whereby the sensor unit 12 is quantified intermittently or continuously with the sensor unit 12 completely embedded in the body of the subject. Is possible.
  • FIG. 4 is a functional block diagram of the calculation unit 18 shown in FIG.
  • the structural elements closely related to the sensing method according to the present invention are mainly illustrated.
  • the sensor control circuit 16 drives the LED element 46 so as to emit the excitation light E at a predetermined time and / or light quantity, and the fluorescence signal obtained from the PD element 42 is converted into a fluorescence intensity F (t). As a fluorescence signal acquisition unit 62.
  • the calculation unit 18 includes a measurement instruction unit 64 that instructs the sensor control circuit 16 (light source control unit 60) to start measurement using the fluorescence sensor 14, and a zone that classifies a predetermined density range into a plurality of zones.
  • the concentration [A (t)] of the analyte A is quantified based on the fluorescence intensity F (t) from the classification unit 66, the measurement / quantification sampling interval Ts, and the fluorescence signal acquisition unit 62.
  • a concentration quantification unit 70 that performs the calculation in the calculation unit 18 and a parameter setting unit 71 (setting unit) that sets various parameters.
  • the interval determination unit 68 includes an attribute determination unit 72 that determines whether each zone (specifically, the L zone, the M zone, and the H zone) belongs to the quantified concentration [A (t)]. It functions as a trend estimator 74 that estimates the variation trend of concentration [A (t)] (hereinafter referred to as “concentration trend” or simply “trend”).
  • step S1 the parameter setting unit 71 performs initial setting of various parameters used for calculation in the calculation unit 18.
  • a user such as a doctor designates a mode suitable for the subject via the input unit 27. This mode is prepared according to the dynamics of the subject, for example, after meals, at bedtime, during exercise, and the like.
  • the parameter setting unit 71 sets various parameters associated with the designated mode. Even when step S2 and the subsequent steps are executed, an interrupt process is generated in response to an operation from the input unit 27, so that the process returns to step S1 to reflect changes in various parameters as needed.
  • step S2 the zone classification unit 66 classifies the predetermined density range into a plurality of zones based on some parameters supplied by the parameter setting unit 71.
  • FIG. 6 is a schematic explanatory diagram showing a classification example of a plurality of zones.
  • the horizontal axis of the graph is time (minute; unit: min), and the vertical axis of the graph is glucose concentration, so-called blood glucose level (unit: mg / dl).
  • the zone classification unit 66 sets two concentration threshold values Dh and Dl (0 ⁇ Dl ⁇ Dh) in a concentration range in which the lower limit value is 0 [mg / dl] and the upper limit value is the maximum measurable value. Are classified into three zones.
  • the zone that satisfies 0 ⁇ [A (t)] ⁇ Dl and exists on the side with the lowest density is the “L zone” (lowest density zone), and the density satisfies Dl ⁇ [A (t)] ⁇ Dh.
  • the zone that exists in the middle is classified as “M zone” (intermediate concentration zone), and the zone that satisfies [A (t)] ⁇ Dh and exists on the side with the highest concentration is classified as “H zone” (highest concentration zone). Is done.
  • the number of zones to be classified is not limited to three, and may be two or four or more.
  • the vertical axis of the graph is not limited to the concentration (blood glucose level), but may be measured raw data ⁇ fluorescence intensity F (t) or fluorescence signal itself ⁇ .
  • the parameter setting unit 71 can collectively set a data set of the sampling interval Ts corresponding to each zone, which is used for determination by the interval determining unit 68.
  • the interval determination unit 68 acquires the data set from the parameter setting unit 71 to determine in advance the value that the sampling interval Ts can take, more specifically, the sampling interval Ts corresponding to each zone.
  • step S3 the calculation unit 18 determines whether or not there is a measurement / quantification instruction for the analyte A. Specifically, the arithmetic unit 18 counts the number of pulses of the clock signal input from the clock generator 26, and when the count reaches an upper limit value (corresponding to the sampling interval Ts when converted to time), it is quantitative. It is determined that there is an instruction. On the other hand, if the count upper limit value has not been reached, it remains in step S3 until it reaches.
  • step S ⁇ b> 4 the measurement instruction unit 64 outputs an instruction signal for starting measurement to the light source control unit 60. Then, the light source control unit 60 causes the LED element 46 to emit light by supplying a predetermined amount of driving current with a predetermined time width. Thereafter, the excitation light E is emitted toward the indicator layer 50 (that is, the analyte A, the labeling compound, or the third component).
  • step S5 the sensor control circuit 16 (fluorescence signal acquisition unit 62) detects the fluorescence F (see FIG. 3) due to the interaction between the analyte A and the labeling compound via the fluorescence sensor 14.
  • the fluorescence signal acquisition unit 62 acquires a fluorescence signal corresponding to the intensity of the fluorescence F, converts the fluorescence signal into the fluorescence intensity F (t) (or as it is), and supplies the fluorescence signal to the calculation unit 18 side. Then, the calculation unit 18 temporarily stores the fluorescence intensity F (t) or the fluorescence signal in the RAM 24.
  • the sensor control circuit 16 may acquire the temperature signal via the temperature sensor 15 in synchronization (or asynchronously) with the acquisition of the fluorescence signal.
  • the concentration quantification unit 70 quantifies the concentration [A (t)] of the analyte A using the acquired fluorescence intensity F (t), the quantification coefficient read from the RAM 24, and the like.
  • the concentration [A (t)] can be quantified by various methods suitable for the material of the fluorescent dye, the nature of the chemical reaction, and the like.
  • step S7 the attribute determination unit 72 determines whether the zone belongs for the concentration [A (t)] determined in step S6. Specifically, the genus determination unit 72 determines that the current quantitative value belongs to the L zone when 0 ⁇ [A (t)] ⁇ Dl is satisfied. Alternatively, the affiliation determination unit 72 determines that the current quantitative value belongs to the M zone when Dl ⁇ [A (t)] ⁇ Dh is satisfied. Alternatively, the genus determination unit 72 determines that the current quantitative value belongs to the H zone when Dh ⁇ [A (t)] is satisfied.
  • the boundary line 100 that divides the L zone and the M zone is indicated by a solid line in the drawing.
  • the determination points P1 and P3 belong to the L zone, and the determination points P2, P4, P5, and P6 belong to the M zone. Is done. As described above, there are cases where time-series fluctuations occur in the determination result related to the affiliation of each zone due to quantitative variation caused by measurement. In this case, there is a possibility of affecting the update control of the sampling interval Ts described later.
  • a dead zone 104 having the boundary line 100 as a lower limit and the boundary line 102 indicated by a broken line as an upper limit may be provided.
  • the previous fixed point P1 belongs to the L zone and the current fixed point P2 belongs to the dead zone 104 (in the M zone)
  • the previous determination result that it belongs to the L zone
  • the fixed points P1, P2, P3, and P4 belong to the L zone
  • the fixed points P5 and P6 belong to the M zone.
  • 8A illustrates the case where the trend is in the rising state (transition from the L zone to the M zone), but the same applies to the case where the trend is in the falling state (transition from the M zone to the L zone). . Note that in this case, the positional relationship between the boundary lines 100 and 102 is reversed. In addition, it goes without saying that various calculation methods can be employed to suppress the above-described fluctuation.
  • step S8 the trend estimation unit 74 estimates a trend from a plurality of latest quantitative values. Specifically, the trend estimation unit 74 obtains the regression line 106 from a plurality of recent quantitative values, and when the gradient is larger than a predetermined positive value, the “rising state”, the gradient is higher than a predetermined negative value. If it is small, it is estimated to be “down state”, otherwise it is estimated to be “flat state”.
  • the regression line 106 (illustrated by a broken line) can be obtained using the past quantification points P1, P2, P3, and P4 and using the current quantification point P5 as necessary.
  • various optimization methods including a weighted average and a least square method can be used.
  • the number of quantitative values used for trend estimation is not limited to five, and may be appropriately determined by comprehensively considering the amount of calculation, processing time, and the like.
  • the trend may be estimated by considering not only the gradient (first derivative of time) but also the curvature (second derivative of time).
  • step S9 the interval determination unit 68 determines and updates the next sampling interval Ts based on whether the zone belongs in step S7 or the trend of the density [A (t)] obtained in step S8.
  • the interval determination unit 68 determines the sampling interval Ts corresponding to the H zone or the L zone so as to be smaller than any of the sampling intervals Ts corresponding to the M zone (at least one intermediate density zone).
  • the interval determination unit 68 determines a relatively small sampling interval Ts in order to increase the number of fixed samples and improve the diagnostic performance.
  • the interval determination unit 68 determines a relatively large sampling interval Ts in order to reduce power consumption by reducing the number of fixed samples.
  • step S10 the indicator 28 displays the quantitative result in step S6.
  • the calculation unit 18 determines visible information (hereinafter referred to as “quantitative visible information”) to be displayed on the display unit 28 from the obtained quantitative results, and then sends a control signal corresponding to the quantitative visible information. Supply to the display 28 side.
  • quantitative visible information not only a quantitative value but a trend, the success or failure of a quantitative measurement, a quantitative time, a diagnostic result, etc. are mentioned, for example.
  • FIGS. 9A and 9B on the display screen 110 provided in the display 28, a number 112 representing a blood glucose level and a mark 114 representing a trend are displayed.
  • the display form of FIG. 9A suggests that the blood glucose level is 100 [mg / dl] and the trend is “increased state”.
  • the display form of FIG. 9B suggests that the blood glucose level is 250 [mg / dl], and the trend is “gradual downward state”.
  • the display update frequency of the numeral 112 and / or the mark 114 may be freely changed.
  • the user can immediately grasp the current quantitative value and the trend by selecting “update every time quantitative determination” is selected.
  • the update frequency of the number 112 may be different from the update frequency of the mark 114.
  • the quantitative value (number 112) may be updated when the trend is “flat”, and the quantitative value (number 112) may not be updated when the trend is “up” or “down”. .
  • step S11 the calculation unit 18 determines whether or not there is an instruction to end the series of quantitative operations. If it is determined that the end instruction has not been given, the process returns to step S3, and steps S3 to S11 are repeated thereafter. On the other hand, when there is an end instruction, the sensing device 10 ends the quantitative operation of the analyte A. In this way, the calculation unit 18 obtains the concentration [A (t)] of the analyte A as time series data for each fixed time point t while appropriately changing the sampling interval Ts.
  • FIG. 10 is a graph showing the change in blood glucose level over time obtained by quantifying the blood glucose concentration according to the determination method shown in FIG. More specifically, the blood glucose level in the body of the subject after meal is quantified intermittently or continuously.
  • the quantification frequency in the M zone is suppressed to about 1/5 compared with the quantification frequency in the H zone and the L zone.
  • the power consumption required for quantification can be reduced by reducing the quantification frequency in the middle blood glucose level state (M zone).
  • the zone classification unit 66 that classifies the predetermined concentration range into a plurality of zones (L zone, M zone, H zone), and a plurality of quantified analyte A concentrations [A (t)]. Since the interval determination unit 68 for determining the sampling interval Ts according to whether the zone belongs or not is provided, the change in the concentration of the analyte A can be grasped globally depending on whether the zone belongs or not. It becomes possible.
  • the sensor used for measurement may include an optical sensor (fluorescence sensor 14) that acquires a measurement signal from a light phenomenon generated by applying energy to a labeling substance or a subject.
  • an optical sensor fluorescence sensor 14
  • quantitative_assay using an optical sensor can be reduced.
  • the fluorescence sensor 14 includes an LED element 46 that emits excitation light E that promotes generation of fluorescence F toward the labeling substance, and emits the excitation light E according to the sampling interval Ts determined by the interval determination unit 68.
  • a light source control unit 60 for controlling the LED element 46 may be further provided.
  • reducing the quantitative frequency greatly contributes to the reduction of power consumption, and thus is particularly effective. It also has an effect of suppressing the deterioration of the fluorescent dye.
  • FIG. 11 is a second table illustrating a method for determining the sampling interval Ts. This determination method differs from the method shown in FIG. 7 in that it considers not only whether or not a plurality of zones belong but also an estimated trend.
  • the parameter setting unit 71 can collectively set a data set of the sampling interval Ts corresponding to the combination of each zone and each trend, which is used for the determination by the interval determining unit 68.

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Abstract

La présente invention concerne un dispositif de détection et un procédé de détection permettant de quantifier la concentration d'un analyte par intermittence ou en continu. Une plage de concentration prédéterminée est classée en une pluralité de zones (zone L, zone M, zone H ). La concentration [A(t)] d'un analyte (A) est quantifiée à partir d'un signal de mesure obtenu au moyen d'un capteur (14). L'intervalle d'échantillonnage (Ts) est ensuite déterminé en fonction de l'appartenance éventuelle de la concentration [A(t)] à ladite pluralité de zones.
PCT/JP2013/056928 2012-03-27 2013-03-13 Dispositif de détection et procédé de détection WO2013146243A1 (fr)

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JP2014507634A JP6109812B2 (ja) 2012-03-27 2013-03-13 センシング装置

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JP2012-071402 2012-03-27
JP2012071402 2012-03-27

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56100343A (en) * 1980-01-14 1981-08-12 Matsushita Electric Works Ltd Photoelectric type smoke sensor
JP2003315306A (ja) * 2002-04-25 2003-11-06 Matsushita Electric Ind Co Ltd 安全センサ
JP2006118939A (ja) * 2004-10-20 2006-05-11 Riken Keiki Co Ltd ガス検知器
WO2010119916A1 (fr) * 2009-04-13 2010-10-21 Olympus Corporation Capteur de fluorescence, capteur de fluorescence de type aiguille et procédé pour mesurer un analyte

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS56100343A (en) * 1980-01-14 1981-08-12 Matsushita Electric Works Ltd Photoelectric type smoke sensor
JP2003315306A (ja) * 2002-04-25 2003-11-06 Matsushita Electric Ind Co Ltd 安全センサ
JP2006118939A (ja) * 2004-10-20 2006-05-11 Riken Keiki Co Ltd ガス検知器
WO2010119916A1 (fr) * 2009-04-13 2010-10-21 Olympus Corporation Capteur de fluorescence, capteur de fluorescence de type aiguille et procédé pour mesurer un analyte

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JPWO2013146243A1 (ja) 2015-12-10
JP6109812B2 (ja) 2017-04-05

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