WO2013157263A1 - 生体情報測定装置とそれを用いた生体情報測定方法 - Google Patents
生体情報測定装置とそれを用いた生体情報測定方法 Download PDFInfo
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- WO2013157263A1 WO2013157263A1 PCT/JP2013/002609 JP2013002609W WO2013157263A1 WO 2013157263 A1 WO2013157263 A1 WO 2013157263A1 JP 2013002609 W JP2013002609 W JP 2013002609W WO 2013157263 A1 WO2013157263 A1 WO 2013157263A1
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- input terminal
- biological information
- hematocrit value
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3274—Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration
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- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12Q—MEASURING OR TESTING PROCESSES INVOLVING ENZYMES, NUCLEIC ACIDS OR MICROORGANISMS; COMPOSITIONS OR TEST PAPERS THEREFOR; PROCESSES OF PREPARING SUCH COMPOSITIONS; CONDITION-RESPONSIVE CONTROL IN MICROBIOLOGICAL OR ENZYMOLOGICAL PROCESSES
- C12Q1/00—Measuring or testing processes involving enzymes, nucleic acids or microorganisms; Compositions therefor; Processes of preparing such compositions
- C12Q1/001—Enzyme electrodes
- C12Q1/005—Enzyme electrodes involving specific analytes or enzymes
- C12Q1/006—Enzyme electrodes involving specific analytes or enzymes for glucose
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
- G01N27/26—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating electrochemical variables; by using electrolysis or electrophoresis
- G01N27/28—Electrolytic cell components
- G01N27/30—Electrodes, e.g. test electrodes; Half-cells
- G01N27/327—Biochemical electrodes, e.g. electrical or mechanical details for in vitro measurements
- G01N27/3271—Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood
- G01N27/3272—Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/48707—Physical analysis of biological material of liquid biological material by electrical means
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/483—Physical analysis of biological material
- G01N33/487—Physical analysis of biological material of liquid biological material
- G01N33/49—Blood
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
- G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
- G01N33/66—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood sugars, e.g. galactose
Definitions
- the present invention relates to, for example, a biological information measuring device for measuring a blood glucose level and a biological information measuring method using the same.
- the configuration of a conventional biological information measuring apparatus for measuring, for example, a blood glucose level is as follows.
- biological information measurement for mounting a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode
- a device wherein a first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input to which the third electrode is connected
- a voltage application unit for applying a voltage to the terminal, the first input terminal, the second input terminal, and the third input terminal; the first input terminal; the second input terminal;
- the configuration includes the determination unit connected to the third input terminal, the control unit connected to the determination unit and the voltage application unit, and the display unit connected to the control unit (for example, The following Patent Document 1).
- a biosensor is attached to the biological information measuring device, and then blood is dropped on the biosensor as a biological sample, and then a blood glucose level is measured as biological information.
- the blood glucose level to be measured fluctuates depending on the hematocrit contained in the blood
- conventionally after measuring the blood glucose level, the hematocrit value is measured, and then the blood glucose level is measured according to the hematocrit value. It was corrected and displayed on the display unit.
- an object of the present invention is to enhance the measurement accuracy of biological information.
- the present invention provides a bio with a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for mounting a sensor comprising: a first input terminal to which the first electrode is connected; a second input terminal to which the second electrode is connected; and the third input terminal A voltage application unit that applies a voltage to a third input terminal to which an electrode is connected, the first input terminal, the second input terminal, and the third input terminal; and the voltage application unit A control unit and a display unit connected to the control unit, the control unit measuring the first biological information based on the current flowing through the first input terminal; And the second input terminal and the second input terminal after the first biological information measurement mode.
- a second biological information measurement mode for measuring a second biological information by applying a voltage to the input terminal of the device
- the display unit is configured to display the second biological information.
- the control unit performs at least one of an application value of voltage or an application time of voltage to the second input terminal and the third input terminal in the second living body information measurement mode in a first living body information measurement mode. It is configured to be variable based on the first biological information in
- the present invention also provides a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device of A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- a pre-processing application mode for applying a voltage to the third input terminal, and a voltage application stop mode for stopping application of voltage to the second input terminal and the third input terminal after the pre-processing application mode; After the voltage application stop mode, a voltage is applied to the second input terminal and the third input terminal to execute a second biological information measurement mode for measuring second biological information.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Configuration.
- the present invention also mounts a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Configuration, and The control unit is configured to apply a voltage application time for applying a voltage to the second input terminal and the third input terminal in the second biological information measurement mode. It is the structure made to be variable based on 1 biometric information.
- the present invention mounts a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- Biological information measuring apparatus for connecting a first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and the third electrode ,
- a voltage application unit for applying a voltage to the first input terminal, the second input terminal, and the third input terminal, and a control unit connected to the voltage application unit.
- a display unit connected to the control unit, the control unit measuring a first biological information based on a current flowing through a first input terminal, and a first biological information measurement mode; After the first biological information measurement mode, the second input terminal and the third input terminal A second biological information measurement mode for applying a voltage and measuring second biological information, and the display unit is configured to display the second biological information; A voltage applied to the second input terminal and the third input terminal in the second living body information measurement mode or at least one of application time of the voltage in the first living body information measurement mode; Since the configuration is made variable based on the biological information, the measurement accuracy can be enhanced.
- the configuration is variable based on the first living body information, and in the first living body information measurement mode, the first living body information, for example, the hematocrit value is measured, and the second living body information measurement is performed based on the hematocrit value.
- the second biological information in the mode for example, a blood glucose level is measured.
- a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for mounting A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- a pre-processing application mode for applying a voltage to the third input terminal, and a voltage application stop mode for stopping application of voltage to the second input terminal and the third input terminal after the pre-processing application mode;
- a voltage is applied to the second input terminal and the third input terminal to execute a second biological information measurement mode for measuring second biological information.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Because it is a configuration to be performed, the measurement accuracy can be enhanced.
- the application value of the voltage to the second input terminal and the third input terminal in the pre-processing application mode is varied based on the first biological information in the first biological information measurement mode.
- the first biological information for example, the hematocrit value
- the second biological information in the second biological information measurement mode for example, , And to measure blood sugar levels.
- a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for mounting A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Configuration, and The control unit is configured to apply a voltage application time for applying a voltage to the second input terminal and the third input terminal in the second biological information measurement mode. Since the configuration is made variable based on the biological information of 1, it is possible to enhance the measurement accuracy.
- the application value of the voltage to the second input terminal and the third input terminal in the pre-processing application mode is varied based on the first biological information in the first biological information measurement mode.
- a voltage application time for applying a voltage to the second input terminal and the third input terminal in the second living body information measurement mode is the first one in the first living body information measurement mode.
- the configuration is variable based on the biological information, and in the first biological information measurement mode, the first biological information, for example, the hematocrit value is measured, and based on the hematocrit value, the second biological information measurement mode is performed.
- the second biological information for example, a blood glucose level is measured.
- the measurement of the second biological information for example, blood glucose level
- the first biological information for example, hematocrit value
- FIG. 1 It is an electric block diagram of a living body information measuring device concerning one embodiment of the present invention.
- A It is an exploded perspective view of a biosensor used for a living body information measuring device concerning one embodiment of the present invention.
- B It is sectional drawing of the biosensor used for the biological information measuring apparatus concerning one Embodiment of this invention.
- It is an operation flow chart of a living body information measuring device concerning one embodiment of the present invention. It is a figure which shows the state of the voltage applied temporally in the biometric information measuring apparatus concerning one Embodiment of this invention. It is a graph which shows a time-dependent change of the response current value (microampere) to application of the voltage of the living body information measuring device concerning one embodiment of the present invention.
- FIG. 1 shows an electrical block diagram of a biological information measuring device according to an embodiment of the present invention.
- Fig.2 (a) is a disassembled perspective view of the biosensor used for the biological information measuring apparatus concerning one Embodiment of this invention.
- FIG. 2B is a cross-sectional view of a biosensor used in the biological information measuring device according to one embodiment of the present invention.
- an insertion port 3 of a biosensor 2 is provided at one end of a main body case 1.
- the biosensor 2 is a hematocrit measurement working electrode (an example of the first electrode) 5 which is four electrodes on the rectangular insulating substrate 4 as an example shown in FIG. 2A.
- the component measurement working electrode (an example of the third electrode) 6, the blood component measurement counter electrode (an example of the second electrode) 7, and the blood component introduction detection electrode 8 are formed to face each other at a predetermined interval.
- biological information to be measured by the biological information measuring device of the present invention include glucose value, lactic acid value, uric acid value, bilirubin value, cholesterol value and the like.
- biological samples for obtaining such biological information include blood, urine, sweat and the like.
- This biosensor 2 is an example in the case of using blood as a biological sample.
- Reference numeral 8 is electrically connected to the biological information measuring apparatus by contacting the input terminal unit 9 shown in FIG.
- the reagent section 10 is disposed on the electrode section formed by the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode 8.
- the reagent 11 is disposed in the reagent unit 10.
- the reagent 11 contains an oxidoreductase such as glucose dehydrogenase and a mediator (electron carrier), and optionally contains, as optional components, a polymer material, an enzyme stabilizer, a crystal homogenizing agent and the like.
- a cover 13 is disposed on the insulating substrate 4 and the reagent 11 via a spacer 12 with one end left.
- a blood supply passage 14 for introducing blood is formed in the spacer 12 of the biosensor 2.
- the blood supply passage 14 extends from the other end side (left end side in FIG. 2) of the biosensor 2 to the upper side of the reagent 11, and the other end side opened to the outside is a blood supply port 15.
- the hematocrit measurement working electrode 5, the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode 8 extend to one end side (right end side in FIG. 2) of the biosensor 2;
- the hematocrit measurement working electrode 5, the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and a part of the blood component introduction detection electrode 8 are exposed without being covered by the cover 13.
- the hematocrit measurement working electrode 5 is connected to the first input terminal (not shown) of the input terminal unit 9, and the blood component measurement working electrode 6 is provided on the input terminal unit 9. Further, the blood component measurement counter electrode 7 is connected to the third input terminal (not shown) of the second embodiment, and the blood component introduction detection electrode 8 is connected to the second input terminal (not shown) of the input terminal unit 9. Each is connected to a fourth input terminal (not shown) of the input terminal unit 9.
- the hematocrit measurement working electrode 5 is arranged closest to the blood supply port 15, and the blood component measurement counter electrode 7 is next The blood component measurement working electrode 6 and finally the blood component introduction detection electrode 8 are disposed.
- the hematocrit measurement working electrode one example of the first electrode
- the blood component measurement counter electrode one example of the second electrode
- An example of the third electrode 6 and the blood component introduction detection electrode 8 are arranged.
- the cover 13 of the biosensor 2 is provided with an air hole 16 for promoting capillary action and causing the blood component introduction detection electrode 8 to enter when blood is spotted on the blood supply port 15. .
- the material of the insulating substrate 4 is not particularly limited.
- polyethylene terephthalate (PET), polycarbonate (PC), polyimide (PI), polyethylene (PE), polypropylene (PP), polystyrene (PS), poly Vinyl chloride (PVC), polyoxymethylene (POM), monomer cast nylon (MC), polybutylene terephthalate (PBT), methacrylic resin (PMMA), ABS resin (ABS), glass, etc. can be used.
- the size of the insulating substrate 4 is not particularly limited, and for example, the total length 5 to 100 mm, the width 2 to 50 mm, and the thickness 0.05 to 2 mm, preferably the total length 7 to 50 mm and the width 3 to 20 mm It is 0.1 to 1 mm, more preferably 10 to 30 mm in length, 3 to 10 mm in width, and 0.1 to 0.6 mm in thickness.
- Each electrode on the insulating substrate 4 can be formed, for example, using gold, platinum, palladium or the like as a material by forming a conductive layer by a sputtering method or a vapor deposition method, and processing it into a specific electrode pattern by a laser.
- a laser for example, a YAG laser, a CO 2 laser, an excimer laser or the like can be used.
- the electrode patterns are not limited to those disclosed in the present invention, and may be any one as long as the effects of the present invention can be realized.
- the electrodes in the biosensor 2 used in the present invention may be coated with a polymeric material for the purpose of preventing adhesion of impurities and oxidation.
- the coating of the surface of the electrode can be carried out, for example, by preparing a solution of a polymeric material, dropping or applying it onto the surface of the electrode, and then drying it. Drying includes, for example, natural drying, air drying, hot air drying, and heat drying.
- the electron carrier of the biosensor 2 to be used is not particularly limited, and examples thereof include ferricyanide, p-benzoquinone, p-benzoquinone derivative, phenazine methosulfate, methylene blue, ferrocene, ferrocene derivative and the like. Among these, ferricyanide is preferable, and potassium ferricyanide is more preferable.
- the compounding amount of the electron carrier is not particularly limited, and is, for example, 0.1 to 1000 mM, preferably 1 to 500 mM, preferably 1 to 500 mM per measurement or per biosensor. It is 200 mM.
- the first biological information is, for example, a hematocrit value.
- the second biological information includes, for example, glucose value, lactic acid value, uric acid value, bilirubin value, cholesterol value and the like.
- the oxidoreductase enzyme in the present invention may be appropriately selected according to the type of the second biological information. Examples of the oxidoreductase include glucose oxidase, lactate oxidase, cholesterol oxidase, bilirubin oxidase, glucose dehydrogenase, lactate dehydrogenase and the like.
- the amount of the oxidoreductase is, for example, 0.01 to 100 U, preferably 0.05 to 10 U, more preferably 0.1 to 100 U, per sensor or per measurement. It is ⁇ 5U.
- a glucose value is preferable as the second biological information, and in this case, the oxidoreductase is preferably glucose oxidase and glucose dehydrogenase.
- the reagent 11 contains, for example, 0.1 to 5.0 U / flavin adenosine dinucleotide-dependent glucose dehydrogenase (FAD-GDH) in an aqueous solution of 0.01 to 2.0 wt% carboxymethylcellulose (CMC).
- a reagent solution is prepared by adding a sensor and 10 to 200 mM of potassium ferricyanide, 1 to 50 mM of maltitol, and 20 to 200 mM of taurine to prepare a reagent solution, which is dropped on the electrode of the insulating substrate 4 and dried. It can be formed by
- the material of the spacer 12 is not particularly limited, and, for example, the same material as the insulating substrate 4 can be used.
- the size of the spacer 12 is not particularly limited, and for example, the total length 5 to 100 mm, the width 2 to 50 mm, and the thickness 0.01 to 1 mm, preferably the total length 7 to 50 mm, the width 3 to 20 mm, and the thickness 0
- the total length is 10 to 30 mm
- the width is 3 to 10 mm
- the thickness is 0.05 to 0.25 mm.
- the spacer 12 is formed with an I-shaped notch which is a blood supply path 14 for introducing blood.
- the reagent portion and the electrode portion are appropriately provided at each end of the blood supply passage so that hematocrit measurement and glucose measurement can be performed separately. It is also possible to practice the invention.
- the material of the cover 13 is not particularly limited, and, for example, the same material as the insulating substrate 4 can be used. It is further preferable to subject the portion of the cover 13 corresponding to the ceiling of the blood supply passage 14 to a hydrophilic treatment.
- the hydrophilic treatment include a method of applying a surfactant, and a method of introducing a hydrophilic functional group such as a hydroxyl group, a carbonyl group or a carboxyl group on the surface of the cover 13 by plasma treatment or the like.
- the size of the cover 13 is not particularly limited, and for example, the total length 5 to 100 mm, the width 3 to 50 mm, and the thickness 0.01 to 0.5 mm, preferably the total length 10 to 50 mm, the width 3 to 20 mm, and the thickness 0 More preferably, the total length is 15 to 30 mm, the width is 5 to 10 mm, and the thickness is 0.05 to 0.1 mm.
- the cover 13 preferably has an air hole 16 formed therein, and the shape is, for example, a circle, an ellipse, or a polygon, and the size thereof is, for example, a maximum diameter of 0.01 to 10 mm, preferably And a maximum diameter of 0.05 to 5 mm, more preferably, a maximum diameter of 0.1 to 2 mm.
- the air holes 16 may be formed by drilling using, for example, a laser, a drill or the like, or may be formed using a mold capable of forming an air vent when forming the cover 13.
- this biosensor 2 can be manufactured by laminating and integrating the insulating substrate 4, the spacer 12 and the cover 13 in this order.
- the three members may be pasted with an adhesive or heat sealed.
- the adhesive for example, an epoxy adhesive, an acrylic adhesive, a polyurethane adhesive, a thermosetting adhesive (hot melt adhesive etc.), a UV curable adhesive and the like can be used.
- the voltage application unit 17 for applying a voltage and the current-voltage conversion unit 18 are connected to the input terminal unit 9 of the biological information measuring apparatus according to the embodiment of the present invention. It is done.
- a voltage is applied to the voltage application unit 17 from the control unit 19, and this voltage is applied via the input terminal unit 9 to the hematocrit measurement working electrode 5 of the biosensor 2, the blood component measurement working electrode 6, the blood component measurement counter electrode 7. , And is applied to a desired one of the blood component introduction detection electrodes 8 for a fixed time.
- the current flowing between the electrodes in the biosensor 2 is converted into a voltage by the current-voltage conversion unit 18, and then this voltage is converted into a digital signal by the AD conversion unit 20, and this digitally converted voltage is judged
- the means 21 compares it with the threshold value.
- the glucose value detected by the biosensor 2 and the determination result by the determination unit 21 are displayed.
- Reference numeral 23 in FIG. 1 denotes a power supply unit for supplying power to the respective units.
- Reference numeral 24 denotes a table including a table including the hematocrit value (first biological information), an applied voltage at the time of glucose measurement, an application time and the like, and a memory unit provided with a calibration curve and calibration table prepared in advance from the environmental temperature.
- a clock 25 is connected to the control unit 19, and the control unit 19 is configured to execute various control operations using the time and time of the clock 25.
- a correction unit 26 is provided in the control unit 19 to correct the measured blood glucose level with the hematocrit value, thereby enhancing the measurement accuracy of the blood glucose level.
- FIG. 4 is a diagram showing the state of the voltage applied over time in the biological information measuring device according to the embodiment of the present invention.
- the first living body information measurement mode A is a first living body information (based on the current flowing through the first input terminal (not shown) of the input terminal portion 9, that is, the hematocrit measurement working electrode 5 ( Hematocrit value) is measured.
- the pre-processing application mode B includes, after the first biological information measurement mode A, the second input terminal (not shown) of the input terminal unit 9 shown in FIG. A voltage is applied to the three input terminals (not shown), that is, the blood component measurement counter electrode 7 and the blood component measurement working electrode 6.
- the voltage application stop mode C includes the second input terminal (not shown) of the input terminal unit 9 and the third input terminal (not shown) of the input terminal unit 9 after the pre-processing application mode B. ), That is, to stop the voltage application to the blood component measuring counter electrode 7 and the blood component measuring electrode 6.
- a second input terminal (not shown) of the input terminal unit 9 and a third input of the input terminal unit 9 are provided.
- a voltage is applied to the terminal (not shown), that is, the blood component measurement counter electrode 7 and the blood component measurement working electrode 6, and the second biological information (glucose value) is measured.
- control unit 19 controls the second input terminal (not shown) of the input terminal unit 9 and the third input terminal (not shown) of the input terminal unit 9 in the pre-processing application mode B. That is, the voltage to the blood component measurement counter electrode 7 and the blood component measurement electrode 6 is variable based on the first biological information (hematocrit value) in the first biological information measurement mode A.
- FIG. 5 is a graph showing the time-dependent change of the response current value ( ⁇ A) with respect to the application of the voltage of the biological information measuring device according to this embodiment.
- FIG. 5 shows the first biological information measurement mode A, the pretreatment application mode B, and the voltage at the hematocrit value (first biological information) of 20%, 45% and 60% in the above configuration.
- It is a figure showing the characteristic of application stop mode C and the 2nd living body information measurement mode D, and the response current value (microampere) in each mode is shown.
- the response current value is high (for example, 60%)
- the response current value is low
- the response current value is high.
- FIG. 3 is an operation flowchart of the biological information measuring apparatus according to this embodiment.
- a plurality of biosensors 2 shown in FIG. 2 are stored in a drying container (not shown), and each time the glucose level (blood glucose level, second biological information) is measured Is taken out of the drying container one by one, and as shown in FIG. 1, one end thereof is inserted into the insertion slot 3 (S1 in FIG. 3, “Install a biosensor”) and electrically connected to the input terminal 9 .
- the control unit 19 understands that the biosensor 2 is attached to the input terminal unit 9, and starts the measurement operation (S2 in FIG. 3, "power of the measuring device is started”).
- control unit 19 controls the applied voltage to the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode of the biosensor 2 through the voltage application unit 17 and the input terminal unit 9. 8 (S3 in FIG. 3, "voltage application to measurement working electrode, measurement counter electrode, detection electrode").
- the applied voltages supplied to the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode 8 are each 0.5 V, for example.
- the user punctures a finger or the like with a lancet or the like to exude blood and cause the blood to drop onto the blood supply port 15 of the biosensor 2 (S4 in FIG. 3, “To the supply port of the biosensor Drop in blood ").
- a current starts to flow between the blood component measurement working electrode 6 and the blood component measurement opposite electrode 7 and between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8, and the current is The voltage is converted, and then A / D converted by the A / D conversion unit 20, and the determination is performed by the determination unit 21 of the control unit 19.
- control unit 19 measures a current value flowing between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7, and a voltage value proportional to the current value and a predetermined threshold (for example, 10 mV) If the value is equal to or higher than the threshold value, then the current value flowing between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8 is measured.
- a predetermined threshold for example, 10 mV
- the determination means 21 of the control unit 19 is sufficient This comparison is repeated until it is determined that the current does not penetrate to 11 and the current value flowing between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7 becomes equal to or more than the threshold (S5 in FIG. Pole-measurement counter electrode current ⁇ threshold value)).
- the current value flowing between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8 is measured, and a voltage value proportional to the current value is compared with a predetermined threshold (for example, 10 mV), It is determined whether or not the threshold value is exceeded. If the current value is lower than the threshold value, it is judged that the deposited blood has not sufficiently penetrated to the reagent 11 and the blood component introduction detection pole 8 and this comparison is repeated until the threshold value is exceeded (FIG. 3 S6, "measurement working electrode-detection electrode current ⁇ ⁇ threshold".
- the determination unit 21 of the control unit 19 determines that the blood volume has been introduced to a sufficient extent.
- the control unit 19 determines between the hematocrit measurement working electrode 5 and the blood component measurement counter electrode 7
- the applied voltage is 1.0 to 3.0 V (in the present embodiment, the applied voltage is 2.5 V)
- the application time is 0.01 to 3.0 seconds (in the present embodiment, the application time is 0.5 sec.) (S7 in FIG. 3; “applied between hemato acting electrode and measurement counter electrode to calculate hematocrit value”).
- an oxidation current depending on the hematocrit value (first biological information) can be detected without being affected by the reagent 11.
- the oxidation current is recognized by the control unit 19 as a voltage value via the current-voltage conversion unit 18 and the A / D conversion unit 20.
- a feature of the present embodiment is that the applied voltage in the pretreatment application mode B is varied by an oxidation current (already converted to a voltage value) depending on the hematocrit value (first biological information) recognized by the control unit 19. It is what you did.
- the applied voltage in the pretreatment application mode B is based on the hematocrit value (first biological information) stored in advance in the memory unit 24, the applied voltage at the time of glucose measurement, the application time, etc.
- the management table is used, and is determined according to the oxidation current (already converted to a voltage value) depending on the detected hematocrit value (first biological information).
- the applied voltage according to the hematocrit value may be changed according to the environmental temperature.
- environmental temperature may be measured by a conventionally known method of measuring environmental temperature as described later.
- correction is performed because the reaction between glucose in blood and the oxidoreductase is an enzyme reaction and is influenced by the environmental temperature.
- the predetermined time for applying the applied voltage may be similarly changed according to the environmental temperature.
- the third application terminal applies the first voltage to the third input terminal in the pre-processing application mode.
- a voltage of 2 may be applied, the first hematocrit value may be selected to be greater than the second hematocrit value, and the first voltage may be smaller than the second voltage.
- the third application terminal applies the first voltage to the third input terminal in the pre-processing application mode.
- a voltage of 2 is applied and a third hematocrit value is indicated
- a third voltage is applied to the second input terminal and the third input terminal in the pre-processing application mode, and the third voltage is applied.
- the hematocrit value of 1 is greater than the second hematocrit value and the third hematocrit value
- the second hematocrit value is greater than the third hematocrit value.
- the first voltage may be selected to be smaller than the second voltage and the third voltage, and the second voltage may be smaller than the third voltage.
- the control unit 19 applies the application voltage determined according to the measured hematocrit value (first biological information) to the blood component measurement working electrode 6
- the blood component measurement counter electrode 7 is applied for a predetermined time, for example, 0.5 to 4.0 seconds (in the present embodiment, 2.0 seconds) (S9 in FIG. 3) -Application between measurement counter electrodes ").
- the voltage application stop mode C in order to further accelerate the reaction in the reagent 11 including glucose in the blood and the oxidoreductase enzyme and the electron carrier, in the voltage application stop mode C, all of the biosensor 2 is The voltage application to the electrodes (hematocrit measurement working electrode 5, blood component measurement working electrode 6, blood component measurement counter electrode 7, and blood component introduction detection electrode 8) is performed for about 0.1 to 5.0 seconds (in this embodiment, Stop for 1.0 second (S10 in FIG. 3, "stop voltage application").
- glucose in blood and the oxidoreductase are reacted for a predetermined time.
- control unit 19 applies a voltage between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7 and causes an enzyme reaction to be placed on the blood component measurement working electrode 6.
- the generated electron carrier in a reduced state is oxidized, and the oxidation current is detected to measure the glucose (blood glucose) value (second biological information).
- the reaction time of glucose and oxidoreductase in this second biological information measurement mode D is, for example, 0.5 to 20 seconds, more preferably 0.5 to 10 seconds.
- an applied voltage is 0.05 to 1.0 V, more preferably 0.1 to 0.8 V, for 1.5 seconds between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7. (In the present embodiment, 0.25 V) is applied.
- the control unit 19 calculates a glucose value (second biological information) (S11 of FIG. 3, “between the measurement working electrode and the measurement counter electrode Final application of voltage ").
- the calculated glucose value (second biological information) is subjected to conventionally known temperature correction (S12 in FIG. 3, “Measurement and correction of glucose value”).
- the enzyme reaction at the time of measuring the glucose value is influenced by the environmental temperature, such temperature correction is performed.
- the step of determining the pre-processing application voltage according to the hematocrit value in S8 of FIG. 3 described above the application voltage and / or time according to the hematocrit value is changed according to the environmental temperature.
- the correction of the glucose value at this stage may or may not be performed, while the step S8 in FIG. 3 “in the stage of determining the pretreatment applied voltage according to the hematocrit value, If no change is made to the applied voltage and time corresponding to the hematocrit value according to the environmental temperature, it is necessary to correct the glucose value at this stage.
- the glucose value obtained by the correction as described above is displayed on the display unit 22 as a final glucose (blood glucose) value (second biological information) (S13 in FIG. 3, "display glucose value").
- the feature of this embodiment is that the applied voltage in the pretreatment application mode B is varied by an oxidation current (already converted to a voltage value) depending on the hematocrit value (first biological information) recognized by the control unit 19. As a result, the blood glucose level displayed on the display unit 22 becomes extremely high in accuracy.
- FIG. 7 is a graph showing a change in output voltage (mV) with respect to the blood glucose level of the biological information measurement device according to one embodiment of the present invention. Specifically, FIG. 7 shows the A / D in FIG. 1 in the second biological information measurement mode D with respect to the blood glucose level when the hematocrit value is 20%, 45% and 60% in the present embodiment. It is a figure showing how the output of the conversion part 20 changes (state before the correction
- FIG. 11 is a graph showing the change of the output voltage (mV) with respect to the blood glucose level of the biological information measuring device of the conventional example. Specifically, FIG. 11 shows A / D conversion in FIG. 1 in the second biological information measurement mode D with respect to blood glucose levels when the hematocrit value is 20%, 45% and 60% in the conventional example. It is a figure showing how the output of the part 20 changes. As understood from FIG. 11, also in this case, even if the hematocrit value is 20%, 45%, and 60%, the output voltage also increases as the blood glucose level increases.
- FIG. 11 is a graph showing the change in the output voltage (mV) with respect to the blood glucose level of the biological information measuring device of the conventional example.
- FIG. 12 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example. Specifically, FIG. 12 shows that the blood glucose values of 100 mg / dl and 350 mg / dl in this conventional example are compared to when the hematocrit value is 45%, and the hematocrit value is 20% and 60%, respectively. It shows the difference (the degree of influence) when the
- the output voltage of the A / D converter 20 largely varies depending on the hematocrit value.
- FIG. 13 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example.
- FIG. 14 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example.
- the measurement accuracy is low.
- FIG. 8 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device according to this embodiment. Specifically, FIG. 8 shows that blood glucose levels of 100 mg / dl and 350 mg / dl in the present embodiment are 60% and 60% when the hematocrit level is 20% as compared to when the hematocrit level is 45%, respectively. It shows the difference (the degree of influence) when it comes to
- FIG. 8 this embodiment is that there is only a difference of about 20% at the hematocrit 20% side, centering on the hematocrit value of 45% when the blood glucose level is 100 mg / dl or 350 mg / dl. It does not occur, and a difference of only about 10% occurs on the hematocrit 60% side.
- the output voltage of the A / D conversion unit 20 has a small variation depending on the hematocrit value.
- FIG. 9 and FIG. 9 and FIG. 10 are graphs showing the difference in sensitivity of the output voltage (mV) to the hematocrit value of the biological information measurement apparatus according to this embodiment.
- mV output voltage
- temperature correction is performed in S12 of FIG. 3, and as a result, measurement accuracy can be further enhanced.
- the applied voltage in the treatment application mode B and the second living body It is not necessary to change the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 in the information measurement mode D.
- FIGS. 15 to 22 show a second embodiment of the present invention.
- the voltage applied between the two is varied as in the first embodiment, and the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 in the second biological information measurement mode D is It is characterized in that it is variable based on the first biological information (hematocrit value) in the biological information measurement mode A.
- FIG. 15 is a diagram showing the state of the voltage applied over time in the biological information measuring device according to this embodiment.
- the first living body information measurement mode A shown in FIG. 15 is a first living body information (based on the current flowing through the first input terminal (not shown) of the input terminal portion 9, that is, the hematocrit measurement working electrode 5). Hematocrit value) is measured.
- the pre-processing application mode B includes, after the first biological information measurement mode A, the second input terminal (not shown) of the input terminal unit 9 shown in FIG. A voltage is applied to the three input terminals (not shown), that is, the blood component measurement counter electrode 7 and the blood component measurement working electrode 6.
- the voltage application stop mode C includes the second input terminal (not shown) of the input terminal unit 9 and the third input terminal (not shown) of the input terminal unit 9 after the pre-processing application mode B. ), That is, to stop the voltage application to the blood component measuring counter electrode 7 and the blood component measuring electrode 6.
- a second input terminal (not shown) of the input terminal unit 9 and a third input of the input terminal unit 9 are provided.
- a voltage is applied to the terminal (not shown), that is, the blood component measurement counter electrode 7 and the blood component measurement working electrode 6, and the second biological information (glucose value) is measured.
- control unit 19 controls the second input terminal (not shown) of the input terminal unit 9 and the third input terminal (not shown) of the input terminal unit 9 in the pre-processing application mode B. That is, the voltage to the blood component measurement counter electrode 7 and the blood component measurement electrode 6 is variable based on the first biological information (hematocrit value) in the first biological information measurement mode A.
- FIG. 16 is a graph showing the time-dependent change of the response current value ( ⁇ A) with respect to the application of the voltage of the biological information measuring device according to another embodiment of the present invention.
- FIG. 16 shows a first biological information measurement mode A, a pretreatment application mode B, a voltage application stop mode C, and a hematocrit value of 20%, 45%, and 60% in the above configuration.
- It is a figure showing the characteristic of living body information measurement mode D of 2, and the response current value (microampere) in each mode is shown.
- the hematocrit value is high (for example, 60%)
- the response current value is low
- the response current value is high.
- FIG. 22 is an operation flowchart of the biological information measuring apparatus according to this embodiment.
- a plurality of biosensors 2 shown in FIG. 2 are stored in a drying container (not shown), and each time the glucose level (blood glucose level, second biological information) is measured Is taken out of the drying container one by one, and as shown in FIG. 1, one end thereof is inserted into the insertion opening 3 (S1 in FIG. 22, “Install the biosensor”) and electrically connected to the input terminal 9 .
- the control unit 19 understands that the biosensor 2 is attached to the input terminal unit 9, and starts the measurement operation (S2 in FIG. 22, "power supply of measuring instrument is started”).
- control unit 19 applies the applied voltage to the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode 8 of the biosensor 2 through the voltage application unit 17 and the input terminal unit 9.
- Each is supplied (S3 in FIG. 22, “voltage application to measurement working electrode, measurement counter electrode, detection electrode”).
- the applied voltages supplied to the blood component measurement working electrode 6, the blood component measurement counter electrode 7, and the blood component introduction detection electrode 8 are each 0.5 V, for example.
- the user punctures a finger or the like with a lancet or the like to exude blood and cause the blood to drop onto the blood supply port 15 of the biosensor 2 (S4 in FIG. 22, “To the supply port of the biosensor Drop in blood ").
- a current starts to flow between the blood component measurement working electrode 6 and the blood component measurement opposite electrode 7 and between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8, and the current is The voltage is converted, and then A / D converted by the A / D conversion unit 20, and the determination is performed by the determination unit 21 of the control unit 19.
- control unit 19 measures a current value flowing between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7, and a voltage value proportional to the current value and a predetermined threshold (for example, 10 mV) If the value is equal to or higher than the threshold value, then the current value flowing between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8 is measured.
- a predetermined threshold for example, 10 mV
- the determination means 21 of the control unit 19 is sufficient This comparison is repeated until it is determined that the current does not penetrate into 11, and the current value flowing between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7 becomes equal to or more than the threshold (S5 in FIG. Pole-measurement counter electrode current ⁇ threshold value)).
- the current value flowing between the blood component measurement working electrode 6 and the blood component introduction detection electrode 8 is measured, and a voltage value proportional to the current value is compared with a predetermined threshold (for example, 10 mV). If it is lower than the threshold value, it is determined that the deposited blood has not sufficiently penetrated to the reagent 11 and the blood component introduction detection pole 8 and this comparison is repeated until it reaches the threshold value or more ( S6 in FIG. 22, "measurement active electrode-detection electrode current ⁇ ⁇ threshold".
- a predetermined threshold for example, 10 mV
- the determination unit 21 of the control unit 19 determines that the blood volume has been introduced to an extent that can be sufficiently measured.
- the control unit 19 determines between the hematocrit measurement working electrode 5 and the blood component measurement counter electrode 7
- the applied voltage is 1.0 to 3.0 V (in the present embodiment, the applied voltage is 2.5 V)
- the application time is 0.01 to 3.0 seconds (in the present embodiment, the application time is 0.5 sec.) (S7 in FIG. 22; “applied between hemato acting electrode and measurement counter electrode to calculate hematocrit value”).
- the hematocrit measurement working electrode 5 and the blood component measurement counter electrode 7 only the blood flowing into here becomes an electron carrier, and as a result, the hematocrit value (first An oxidation current dependent on biological information can be detected.
- the oxidation current is recognized by the control unit 19 as a voltage value via the current-voltage conversion unit 18 and the A / D conversion unit 20.
- the feature of this embodiment is that the voltage applied in the pretreatment application mode B and the second voltage are generated by an oxidation current (already converted to a voltage value) depending on the hematocrit value (first biological information) recognized by the control unit 19.
- the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement electrode 6 in the biological information measurement mode D is variable.
- the applied voltage in the pretreatment application mode B is based on the hematocrit value (first biological information) stored in advance in the memory unit 24, the applied voltage at the time of glucose measurement, the application time, etc.
- the management table is used, and is determined according to the oxidation current (already converted to a voltage value) depending on the detected hematocrit value (first biological information).
- the applied voltage according to the hematocrit value may be changed according to the environmental temperature.
- environmental temperature may be measured by a conventionally known method of measuring environmental temperature as described later.
- correction is performed because the reaction between glucose in blood and the oxidoreductase is an enzyme reaction and is influenced by the environmental temperature.
- the predetermined time for applying the applied voltage may be similarly changed according to the environmental temperature.
- the second input terminal and the second input terminal are not selected in the preprocessing application mode.
- a first voltage is applied to a third input terminal and a second hematocrit value is indicated, the second application terminal and the third input terminal are applied in the pre-processing application mode, A second voltage may be applied, the first hematocrit value may be selected to be greater than the second hematocrit value, and the first voltage may be less than the second voltage.
- the second input terminal and the second input terminal are not selected in the preprocessing application mode.
- a first voltage is applied to a third input terminal and a second hematocrit value is indicated
- the second application terminal and the third input terminal are applied in the pre-processing application mode
- a second voltage is applied and a third hematocrit value is indicated
- a third voltage is applied to the second input terminal and the third input terminal in the pretreatment application mode, and the third voltage is applied.
- a first hematocrit value is greater than the second hematocrit value and the third hematocrit value, and the second hematocrit value is the third hematocrit value. Greater than the first voltage, the smaller than the second voltage and the third voltage, the second voltage may be selected to be less than the third voltage.
- the control unit 19 applies the application voltage determined according to the measured hematocrit value (first biological information) to the blood component measurement working electrode 6
- a predetermined time for example, 0.5 to 4.0 seconds (in this embodiment, 2.0 seconds) is applied between the blood component measurement counter electrodes 7 (S9 in FIG. 22) Applied between the pole and the measurement counter electrode ").
- the voltage application stop mode C in order to further accelerate the reaction in the reagent 11 including glucose in the blood and the oxidoreductase enzyme and the electron carrier, in the voltage application stop mode C, all of the biosensor 2 is
- the voltage application to the electrodes is performed for about 0.1 to 5.0 seconds (in the present embodiment, , 1.0 second) (S10 in FIG. 22, "stop voltage application").
- glucose in blood and the oxidoreductase are reacted for a predetermined time.
- the control unit 19 applies a voltage between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7, and the voltage is generated on the blood component measurement working electrode 6 by the enzyme reaction.
- the glucose (blood sugar) value (second biological information) is measured.
- the reaction time of glucose and oxidoreductase in this second biological information measurement mode D is, for example, 0.5 to 20 seconds, more preferably 0.5 to 10 seconds.
- the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 in the second biological information measurement mode D is the first biological information in the first biological information measurement mode A. Variable based on (hematocrit value).
- an applied voltage of 0.05 to 1.0 V, more preferably 0.1 to 0.8 V, is preferably applied between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7.
- 0.25 V is applied, but the voltage application time is varied based on the first biological information (hematocrit value) in the first biological information measurement mode A (S11 in FIG. 22). "Measuring working electrode-final application of voltage between measurement counter electrodes").
- the blood component measurement counter electrode 7 and the blood component in the second living body information measurement mode D The voltage application time between the component measurement working electrodes 6 is 2.0 seconds.
- the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 is 1.0 second.
- the voltage application time between the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 is 0.8 seconds.
- the second input terminal when the hematocrit value (first biological information) indicates the first hematocrit value in the memory unit 24, the second input terminal is selected in the second biological information measurement mode. And applying a fourth voltage to the third input terminal for a first time to indicate a second hematocrit value, the second input terminal and the second input terminal in the second biological information measurement mode. Applying a fourth voltage to the third input terminal for a second time, The first hematocrit value may be larger than the second hematocrit value, and the second time may be selected to be longer than the first time.
- the second input when the hematocrit value (first biological information) indicates the first hematocrit value in the memory unit 24, the second input can be selected in the second biological information measurement mode.
- a fourth voltage is applied to the terminal and the third input terminal for a first time, and a second hematocrit value is indicated, the second input terminal and the second input terminal in the second biological information measurement mode.
- a fourth voltage is applied to the third input terminal for a second period of time and a third hematocrit value is indicated
- the second input terminal and the second input terminal in the second biological information measurement mode A fourth voltage is applied to the third input terminal for a third time, and the first hematocrit value is larger than the second hematocrit value and the third hematocrit value.
- the second hematocrit value is greater than the third hematocrit value, and the second time and the third time are longer than the first time, and the third time is the second time. You can choose to be longer than time.
- control unit 19 calculates a glucose value (second biological information).
- the calculated glucose value (second biological information) is subjected to conventionally known temperature correction (S12 in FIG. 22, “Measurement and correction of the glucose value in the determined final application time”) ).
- the enzyme reaction at the time of measuring the glucose value is influenced by the environmental temperature, such temperature correction is performed.
- the step of determining the pre-processing application voltage according to the hematocrit value in S8 of FIG. 3 described above the application voltage and / or time according to the hematocrit value is changed according to the environmental temperature.
- the correction of the glucose value at this stage may or may not be performed, while the step S8 in FIG. 3 “in the stage of determining the pretreatment applied voltage according to the hematocrit value, If no change is made to the applied voltage and time corresponding to the hematocrit value according to the environmental temperature, it is necessary to correct the glucose value at this stage.
- the glucose value obtained by the correction as described above is displayed on the display unit 22 as a final glucose (blood sugar) value (second biological information) (S13 in FIG. 22, "display glucose value").
- the feature of this embodiment is that the applied voltage in the pretreatment application mode B is varied by the oxidation current (already converted to a voltage value) depending on the hematocrit value (first biological information) recognized by the control unit 19 and
- the voltage application time in the second living body information measurement mode D is variable based on the first living body information (hematocrit value) in the first living body information measurement mode A, and as a result, the display unit 22
- the displayed blood glucose level is extremely accurate.
- FIG. 18 is a graph showing a change in output voltage (mV) with respect to the blood glucose level of the biological information measurement device according to another embodiment of the present invention. Specifically, FIG. 18 shows the A / D in FIG. 1 in the second biological information measurement mode D when the hematocrit value is 20%, 45%, and 60% in the present embodiment. It is a figure showing how the output of the conversion part 20 changes (state before the correction
- FIG. 11 is a graph showing the change of the output voltage (mV) with respect to the blood glucose level of the biological information measuring device of the conventional example. Specifically, FIG. 11 shows A / D conversion in FIG. 1 in the second biological information measurement mode D with respect to blood glucose levels when the hematocrit value is 20%, 45% and 60% in the conventional example. It is a figure showing how the output of the part 20 changes. As understood from FIG. 11, also in this case, even if the hematocrit value is 20%, 45%, and 60%, the output voltage also increases as the blood glucose level increases.
- the output voltage applied between the blood component measurement working electrode 6 and the blood component measurement counter electrode 7 is varied as shown in FIG.
- the difference in the output voltage due to the hematocrit value can be reduced.
- FIG. 11 is a graph showing the change in the output voltage (mV) with respect to the blood glucose level of the biological information measuring device of the conventional example.
- FIG. 12 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example. Specifically, FIG. 12 shows that the blood glucose values of 100 mg / dl and 350 mg / dl in this conventional example are compared to when the hematocrit value is 45%, and the hematocrit value is 20% and 60%, respectively. It shows the difference (the degree of influence) when the
- the output voltage of the A / D converter 20 largely varies depending on the hematocrit value.
- FIG. 13 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example.
- FIG. 14 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device of the conventional example.
- the measurement accuracy is low.
- FIG. 19 is a graph showing the sensitivity difference of the output voltage (mV) to the hematocrit value of the biological information measuring device according to this embodiment. Specifically, FIG. 19 shows that blood glucose levels of 100 mg / dl and 350 mg / dl in the present embodiment are 60% and 60% when the hematocrit level is 20% as compared to when the hematocrit level is 45%, respectively. It shows the difference (the degree of influence) when it comes to
- the output voltage of the A / D conversion unit 20 has a small variation depending on the hematocrit value.
- FIGS. 20 and 21 are graphs showing the difference in sensitivity of the output voltage (mV) to the hematocrit value of the biological information measurement apparatus according to this embodiment.
- mV output voltage
- the measurement accuracy can be made high.
- the temperature correction is performed in S12 of FIG. 22. As a result, the measurement accuracy can be further enhanced.
- the applied voltage in the treatment application mode B and the second living body It is not necessary to change the voltage application time in the information measurement mode D.
- the applied voltage is changed in the pre-application processing mode B.
- the applied voltage is changed in the pre-application processing mode B and the application time is changed in the second biological information measurement mode D.
- the control operation of the control unit 19 may be as shown in FIG. 23 using the configurations of FIG. 1 and FIG.
- FIG. 23 is a diagram showing the state of the voltage applied with time in the biological information measuring device according to still another embodiment of the present invention.
- the control operation shown in FIG. 23 mainly executes the first biological information measurement mode A and the second biological information measurement mode D.
- the hematocrit value (first biological information) is measured in the first biological information measurement mode A, and thereafter, the voltage application stop mode in the first and second embodiments is performed.
- the second biological information measurement mode D is executed immediately after the stopping time of C).
- the control unit 19 performs a second biological information measurement mode based on the hematocrit value (first biological information) measured in the first biological information measurement mode A.
- the value of the voltage applied to the blood component measurement counter electrode 7 and the blood component measurement electrode 6 in D is varied, and the voltage application time is also varied.
- FIG. 24 is a figure which shows the state of the voltage applied temporally in the biometric information measuring apparatus concerning further another embodiment of this invention.
- the control operation shown in FIG. 24 shows still another embodiment of the present invention, and executes the first biological information measurement mode A, the voltage application stop mode C, and the second biological information measurement mode D.
- the hematocrit value (first biological information) is measured in the first biological information measurement mode A, and then voltage application to the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 In the voltage application stop mode C for stopping the second biological information measurement mode D.
- the control unit 19 executes the second biological information measurement mode based on the hematocrit value (first biological information) measured in the first biological information measurement mode A.
- FIG. 25 is a diagram showing the state of the voltage applied with time in the biological information measurement device according to still another embodiment of the present invention.
- the control operation shown in FIG. 25 shows still another embodiment of the present invention, and causes the first living body information measurement mode A and the second living body information measurement mode D to be executed.
- the hematocrit value (first biological information) is measured in the first biological information measurement mode A before the start of measurement (during blood detection standby), and immediately the second living body is measured.
- the information measurement mode D is executed.
- the control unit 19 performs the second biological information measurement mode based on the hematocrit value (first biological information) measured in the first biological information measurement mode A.
- the value of the voltage applied to the blood component measurement counter electrode 7 and the blood component measurement electrode 6 in D is varied, and the voltage application time is also varied.
- FIG. 26 is a figure which shows the state of the voltage applied temporally in the biometric information measuring apparatus concerning further another embodiment of this invention.
- the control operation shown in FIG. 26 shows still another embodiment of the present invention, and executes the first biological information measurement mode A, the voltage application stop mode C, and the second biological information measurement mode D.
- the hematocrit value (first biological information) is measured in the first biological information measurement mode A before the start of measurement (during blood detection standby), and thereafter (at the start of measurement)
- the second biological information measurement mode D is executed.
- the control unit 19 performs the second biological information measurement mode based on the hematocrit value (first biological information) measured in the first biological information measurement mode A.
- FIG. 27 is a diagram showing the state of the voltage applied over time in the biological information measurement device according to still another embodiment of the present invention.
- the control operation shown in FIG. 27 shows still another embodiment of the present invention, and executes the pretreatment application mode B, the first biological information measurement mode A, the voltage application stop mode C and the second biological information measurement mode D.
- the control unit 19 changes the voltage and time to be applied to the blood component measurement counter electrode 7 and the blood component measurement working electrode 6 in the second biological information measurement mode D.
- the voltage application stop mode C or a short time may be provided before and after the first biological information measurement mode A.
- the applied voltage and voltage in the second biological information measurement mode D There is no need to change the application time.
- a living body for mounting a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second and third electrodes.
- An information measurement device comprising: a first input terminal to which the first electrode is connected; a second input terminal to which the second electrode is connected; and a third to which the third electrode is connected
- a voltage application unit for applying a voltage to the first input terminal, the second input terminal, and the third input terminal, the first input terminal, the second input terminal,
- a determination unit connected to the third input terminal, a control unit connected to the determination unit and the voltage application unit, and a display unit connected to the control unit,
- the control unit including: First biological information measurement that measures first biological information based on current flowing to a first input terminal A second biological information measurement mode for measuring a second biological information by applying a voltage to the second input terminal and the third input terminal after the first biological information measurement mode;
- the display unit is configured to display the second biological information
- the control unit is configured to
- At least one of the application value of voltage or the application time of voltage to the second input terminal and the third input terminal in the second biological information measurement mode corresponds to the first biological information measurement mode.
- the configuration is variable based on the first biological information, and in the first biological information measurement mode, for example, the hematocrit value is measured, and based on the hematocrit value, biological information in the second biological information measurement mode, for example, , And to measure blood sugar levels.
- a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for mounting A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a determination unit connected to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the determination unit and the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- a pre-processing application mode for applying a voltage to the third input terminal, and a voltage application stop mode for stopping application of voltage to the second input terminal and the third input terminal after the pre-processing application mode;
- a voltage is applied to the second input terminal and the third input terminal to execute a second biological information measurement mode for measuring second biological information.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Because it is a configuration to be performed, the measurement accuracy can be enhanced.
- the application value of the voltage to the second input terminal and the third input terminal in the pre-processing application mode is varied based on the first biological information in the first biological information measurement mode.
- the first biological information measurement mode for example, the hematocrit value is measured
- biological information in the second biological information measurement mode for example, the blood glucose level is measured.
- a biosensor having a first electrode, a second electrode, and a third electrode, and a reagent portion provided between the second electrode and the third electrode.
- a biological information measuring device for mounting A first input terminal to which the first electrode is connected, a second input terminal to which the second electrode is connected, and a third input terminal to which the third electrode is connected;
- a voltage application unit that applies a voltage to the first input terminal, the second input terminal, and the third input terminal;
- a determination unit connected to the first input terminal, the second input terminal, and the third input terminal;
- a control unit connected to the determination unit and the voltage application unit;
- a display unit connected to the control unit; Equipped with The control unit is configured to measure a first biological information measurement mode for measuring first biological information based on a current flowing through the first input terminal, and the second input terminal after the first biological information measurement mode.
- the display unit is configured to display the second biological information.
- the control unit can change an application value of a voltage to the second input terminal and the third input terminal in the pre-processing application mode based on the first biological information in the first biological information measurement mode. Configuration, and The control unit is configured to apply a voltage application time for applying a voltage to the second input terminal and the third input terminal in the second biological information measurement mode. Since the configuration is made variable based on the biological information of 1, it is possible to enhance the measurement accuracy.
- the application value of the voltage to the second input terminal and the third input terminal in the pre-processing application mode is varied based on the first biological information in the first biological information measurement mode.
- a voltage application time for applying a voltage to the second input terminal and the third input terminal in the second living body information measurement mode is the first one in the first living body information measurement mode.
- the configuration is variable based on biological information, and in the first biological information measurement mode, for example, the hematocrit value is measured, and based on the hematocrit value, biological information in the second biological information measurement mode, for example, blood sugar It measures the value.
- the measurement accuracy can be made high.
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Abstract
Description
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、前記第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変する構成である。
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、
を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であり、
前記制御部は、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対して電圧を印加する電圧印加時間を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成である。
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、前記第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であるので、測定精度を高めることが出来るのである。
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、
を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であり、
前記制御部は、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対して電圧を印加する電圧印加時間を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であるので、測定精度を高めることが出来るのである。
図1は、本発明の一実施形態の生体情報測定装置の電気ブロック図を示す。図2(a)は、本発明の一実施形態にかかる生体情報測定装置に用いるバイオセンサの分解斜視図である。図2(b)は、本発明の一実施形態にかかる生体情報測定装置に用いるバイオセンサの断面図である。図1に示すように、この生体情報測定装置において、本体ケース1の一端にはバイオセンサ2の挿入口3が設けられている。
図15~図22は、本発明の実施の形態2を示すものである。この実施の形態2においては、第1の生体情報測定モードAで測定したヘマトクリット値(第1の生体情報)に応じて、前処理印加モードBにおける血液成分測定対極7および血液成分測定作用極6間への印加電圧を実施の形態1と同様に可変し、さらに、第2の生体情報測定モードDにおける血液成分測定対極7および血液成分測定作用極6間への電圧印加時間を、第1の生体情報測定モードAにおける第1の生体情報(ヘマトクリット値)に基づいて可変させる構成であることを特徴とする。
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第2の時間は、前記第1の時間よりも長くなるよう選択すればよい。
以上の実施の形態1では前印加処理モードBにおける印加電圧の可変、実施の形態2では、前印加処理モードBにおける印加電圧の可変および第2の生体情報測定モードDにおける印加時間の可変を行ったが、図1および図2の構成を活用し、制御部19の制御動作を図23に示すようにしてもよい。
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に接続された判定部と、
前記判定部および前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、前記第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であるので、測定精度を高めることが出来るのである。
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に接続された判定部と、
前記判定部および前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、
を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変する構成であり、
前記制御部は、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対して電圧を印加する電圧印加時間を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であるので、測定精度を高めることが出来るのである。
2 バイオセンサ
3 挿入口
4 絶縁基板
5 ヘマトクリット測定作用極
6 血液成分測定作用極
7 血液成分測定対極
8 血液成分導入検知極
9 入力端子部
10 試薬部
11 試薬
12 スペーサー
13 カバー
14 血液供給路
15 血液供給口
16 空気孔
17 電圧印加部
18 電流-電圧変換部
19 制御部
20 A/D変換部
21 判定手段
22 表示部
23 電源部
24 メモリ部
25 時計
26 補正手段
Claims (26)
- 第1の電極、第2の電極、および第3の電極と、前記第2の電極および前記第3の電極の間に設けた試薬部とを有するバイオセンサを装着するための生体情報測定装置であって、
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、前記第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、
を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値または電圧の印加時間の少なくとも一方を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成である生体情報測定装置。 - 前記制御部には、時計を接続した請求項1記載の生体情報測定装置。
- 前記制御部には、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値または電圧の印加時間の少なくとも一方を設定するためのデータが記録されたメモリ部を接続した請求項1または2に記載の生体情報測定装置。
- 前記生体情報測定装置が、前記第2の入力端子および前記第3の入力端子に接続された判定部をさらに備え、
前記判定部は、前記制御部に接続され、
前記判定部が、前記第2の入力端子と前記第3の入力端子を通じて、前記第2の電極と前記第3の電極の間を流れる電流を、閾値と比較する請求項1から請求項3のいずれか一つに記載の生体情報測定装置。 - 第1の電極、第2の電極、および第3の電極と、前記第2の電極および前記第3の電極の間に設けた試薬部とを有するバイオセンサを装着するための生体情報測定装置であって、
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、前記第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成である生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報が、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第2の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第1の電圧は前記第2の電圧よりも小さい請求項5に記載の生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報が、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、
第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第2の電圧を印加し、第3のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第3の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値および前記第3のヘマトクリット値よりも大きく、前記第2のヘマトクリット値は前記第3のヘマトクリット値よりも大きく、
前記第1の電圧は、前記第2の電圧および前記第3の電圧よりも小さく、前記第2の電圧は前記第3の電圧よりも小さい請求項5に記載の生体情報測定装置。 - 第1の生体情報測定モードにおいては、前記第1の入力端子と前記第2の入力端子との間に流れる電流が測定される構成である請求項5から7のいずれか一つに記載の生体情報測定装置。
- 前記制御部には、時計を接続した請求項5から8のいずれか一つに記載の生体情報測定装置。
- 前記制御部には、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を設定するためのデータが記録されたメモリ部を接続した請求項9に記載の生体情報測定装置。
- 前記生体情報測定装置が、前記第2の入力端子および前記第3の入力端子に接続された判定部をさらに備え、
前記判定部は、前記制御部に接続され、
前記判定部が、前記第2の入力端子と前記第3の入力端子を通じて、前記第2の電極と前記第3の電極の間を流れる電流を、閾値と比較する請求項5から請求項10のいずれか一つに記載の生体情報測定装置。 - 第1の電極、第2の電極、および第3の電極と、前記第2の電極および前記第3の電極の間に設けた試薬部とを有するバイオセンサを装着するための生体情報測定装置であって、
前記第1の電極が接続される第1の入力端子と、前記第2の電極が接続される第2の入力端子と、前記第3の電極が接続される第3の入力端子と、
前記第1の入力端子、前記第2の入力端子、および前記第3の入力端子に電圧を印加する電圧印加部と、
前記電圧印加部に接続された制御部と、
前記制御部に接続された表示部と、
を備え、
前記制御部は、第1の入力端子に流れる電流にもとづいて第1の生体情報を測定する第1の生体情報測定モードと、前記第1の生体情報測定モードの後に前記第2の入力端子および前記第3の入力端子に電圧を印加する前処理印加モードと、前記前処理印加モードの後に前記第2の入力端子および前記第3の入力端子に対する電圧印加を停止する電圧印加停止モードと、前記電圧印加停止モードの後に、前記第2の入力端子および前記第3の入力端子に電圧を印加し、第2の生体情報を測定する第2の生体情報測定モードと、
を実行させる構成であり、
前記表示部は、前記第2の生体情報を表示させる構成であり、
前記制御部は、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成であり、
前記制御部は、前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対して電圧を印加する電圧印加時間を、前記第1の生体情報測定モードにおける前記第1の生体情報に基づいて可変させる構成である生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報は、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第2の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第1の電圧は前記第2の電圧よりも小さい請求項12に記載の生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報は、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第2の電圧を印加し、第3のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第3の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値および前記第3のヘマトクリット値よりも大きく、前記第2のヘマトクリット値は前記第3のヘマトクリット値よりも大きく、
前記第1の電圧は、前記第2の電圧および前記第3の電圧よりも小さく、前記第2の電圧は前記第3の電圧よりも小さい請求項12に記載の生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報は、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、第2の生体情報測定モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第4の電圧を第1の時間印加し、第2のヘマトクリット値を示す時には、前記第2の生体情報測定モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第4の電圧を第2の時間印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第2の時間は、前記第1の時間よりも長い請求項12から14のいずれか一つに記載の生体情報測定装置。 - 前記試薬部が、血液に反応する試薬を含み、
前記第1の生体情報は、ヘマトクリット値であり、前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記第2の生体情報測定モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第4の電圧を第1の時間印加し、第2のヘマトクリット値を示す時には、前記第2の生体情報測定モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第4の電圧を第2の時間印加し、第3のヘマトクリット値を示す時には、前記第2の生体情報測定モードにおいて、前記第2の入力端子および前記第3の入力端子に対して、第4の電圧を第3の時間印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値および前記第3のヘマトクリット値よりも大きく、前記第2のヘマトクリット値は前記第3のヘマトクリット値よりも大きく、前記第2の時間および前記第3の時間は、前記第1の時間よりも長く、前記第3の時間は、前記第2の時間よりも長い請求項12から15のいずれか一つに記載の生体情報測定装置。 - 前記制御部には、時計を接続した請求項12から16のいずれか一つに記載の生体情報測定装置。
- 前記制御部には、前記前処理印加モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加値および前記第2の生体情報測定モードにおける前記第2の入力端子および前記第3の入力端子に対する電圧の印加時間を設定するためのデータが記録されたメモリ部を接続した請求項17記載の生体情報測定装置。
- 前記生体情報測定装置が、前記第2の入力端子および前記第3の入力端子に接続された判定部をさらに備え、
前記判定部が、前記制御部に接続され、
前記判定部が、前記第2の入力端子と前記第3の入力端子を通じて、前記第2の電極と前記第3の電極の間を流れる電流を、閾値と比較する請求項12から請求項18のいずれか一つに記載の生体情報測定装置。 - 請求項1から16のいずれか一つに記載の生体情報測定装置を用いた生体情報測定方法であって、
前記バイオセンサを前記生体情報測定装置に装着し、
次に前記バイオセンサに生体試料を点着し、
その後、生体情報を測定する生体情報測定方法。 - 血液存在下に、作用極および対極を有する第1の電極系に第1の電圧を印加し、酸化電流を検出し、前記酸化電流の値をヘマトクリット値に換算する第1の生体情報を測定する工程と、
作用極および対極を有する第2の電極系に第2の電圧を一定時間印加し、メディエータの存在下、血液中の成分を酸化還元酵素で酸化還元して、その際に生じる酸化還元電流を前記第2の電極系で検出し、前記酸化還元電流の値を、血液中の成分の量に換算して、第2の生体情報を測定する工程とを含む、
血液中の成分の量を測定する方法であって、
前記第2の生体情報を測定する工程における前記第2の電圧または前記一定時間の少なくとも一方が、前記ヘマトクリット値に基づいて可変される測定方法。 - 血液存在下に、作用極および対極を有する第1の電極系に電圧を印加し、酸化電流を検出し、前記酸化電流の値をヘマトクリット値に換算する第1の生体情報を測定する工程と、
前記血液存在下に、作用極および対極を有する第2の電極系に電圧を印加する前処理工程と、
前記血液存在下に、前記第1の電極系および前記第2の電極系へ電圧を印加せず、メディエータの存在下、血液中の成分を酸化還元酵素で酸化還元させる電圧停止工程と、
前記血液存在下、前記第2の電極系へ電圧を印加し、前記第2の電極系上のメディエータを酸化して、その酸化電流を検出し、前記酸化還元電流の値を、血液中の成分の量に換算して、第2の生体情報を測定する工程とを含む、
血液中の成分の量を測定する方法であって、
前記前処理工程における電圧の印加値が、前記ヘマトクリット値に基づいて可変される測定方法。 - 前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加工程において、前記第2の電極系に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加工程において、前記第2の電極系に対して、第2の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第1の電圧は前記第2の電圧よりも小さい請求項22に記載の測定方法。 - 血液存在下に、作用極および対極を有する第1の電極系に電圧を印加し、酸化電流を検出し、前記酸化電流の値をヘマトクリット値に換算する第1の生体情報を測定する工程と、
前記血液存在下に、作用極および対極を有する第2の電極系に電圧を印加する前処理工程と、
前記血液存在下に、前記第1の電極系および前記第2の電極系へ電圧を印加せず、メディエータの存在下、血液中の成分を酸化還元酵素で酸化還元させる電圧停止工程と、
前記血液存在下、前記第2の電極系へ電圧を一定時間印加し、前記第2の電極系上のメディエータを酸化して、その酸化電流を検出し、前記酸化還元電流の値を、血液中の成分の量に換算して、第2の生体情報を測定する工程とを含む、
血液中の成分の量を測定する方法であって、
前記前処理工程における電圧の印加値または前記第2の生体情報を測定する工程における前記一定時間の少なくとも一方が、前記ヘマトクリット値に基づいて可変される測定方法。 - 前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の電極系に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の電極系に対して、第2の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値よりも大きく、前記第1の電圧は前記第2の電圧よりも小さい請求項24に記載の測定方法。 - 前記ヘマトクリット値が、第1のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の電極系に対して、第1の電圧を印加し、第2のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の電極系に対して、第2の電圧を印加し、第3のヘマトクリット値を示す時には、前記前処理印加モードにおいて、前記第2の電極系に対して、第3の電圧を印加し、
前記第1のヘマトクリット値は、前記第2のヘマトクリット値および前記第3のヘマトクリット値よりも大きく、前記第2のヘマトクリット値は前記第3のヘマトクリット値よりも大きく、
前記第1の電圧は、前記第2の電圧および前記第3の電圧よりも小さく、前記第2の電圧は前記第3の電圧よりも小さい請求項24に記載の測定方法。
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| JP7755453B2 (ja) | 2021-10-29 | 2025-10-16 | アークレイ株式会社 | 測定方法及び測定装置 |
Also Published As
| Publication number | Publication date |
|---|---|
| US9625442B2 (en) | 2017-04-18 |
| US20150059448A1 (en) | 2015-03-05 |
| US10012610B2 (en) | 2018-07-03 |
| EP2840389B1 (en) | 2017-08-16 |
| EP2840389A1 (en) | 2015-02-25 |
| JP5940719B2 (ja) | 2016-06-29 |
| US20180128768A1 (en) | 2018-05-10 |
| EP2840389A4 (en) | 2015-04-15 |
| JP5775967B2 (ja) | 2015-09-09 |
| JP2015200672A (ja) | 2015-11-12 |
| US9804115B2 (en) | 2017-10-31 |
| US20170234824A1 (en) | 2017-08-17 |
| JPWO2013157263A1 (ja) | 2015-12-21 |
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