JP2006167269A - Bioinformation measuring method and apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a bioinformation measuring method capable of continuously measuring highly precise bioinformation with reduced pain inflicted on a subject. <P>SOLUTION: This bioinformation measuring method is provided with: a first detecting process detecting characteristic information by a subcutaneous body fluid sensor making contact with subcutaneous body fluid of the subject and electrically detecting predetermined characteristic information; a second detecting process detecting intrinsic information from the blood collected from the subject around the same time as the first detecting process by a blood sensor making contact with the blood and detecting the intrinsic information related to the same characteristic as the characteristic information; and a calibration process calibrating the characteristic information continuously detected by the subcutaneous body fluid sensor and obtaining predetermined bioinformation based on the characteristic information obtained by the first detecting process and the intrinsic information obtained by the second detecting process. This method can executes the calibration corresponding to the characteristics of the subcutaneous body fluid sensor at the time of the use and provide a plurality of pieces of bioinformation by a single blood collection and further painless subcutaneous body fluid sensor. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a biological information measuring method and a biological information measuring device for measuring biological information such as blood glucose level.

  Conventionally, in order to measure a blood sugar level, blood is collected from a vein, fingertip, earlobe, etc., and the concentration of sugar is detected and measured from the blood by various detectors such as a glucose sensor. These methods are painful and the blood collection itself is often accompanied by mental distress. For this reason, there has been a search for a method for measuring the blood glucose level while further reducing the suffering of the subject.For example, the present inventors have directly collected biological information such as blood glucose level from the subcutaneous body fluid without collecting the body fluid. Has been proposed (see, for example, Patent Documents 1 and 2). In this apparatus, the sensor is formed in a needle shape, and it is possible to measure biological information such as a blood glucose level as it is by inserting the sensor at a depth at which it is difficult to reach the pain point of the skin. For this reason, the actual pain can be reduced, and the mental pain of the measurement subject can be reduced by not having to collect blood. Furthermore, this sensor can measure changes in blood glucose level continuously for a long time by leaving the skin pierced.

JP 2003-190122 A JP 2004-208727 A

Since such a sensor detects a value from a finer body fluid as compared with the case where collected blood is used, in order to obtain an accurate result, processing according to the sensor characteristics is important. However, there is a possibility that the measurement error will increase if the processing method is determined in advance because there is a change in characteristics over time, for example, the output decreases immediately after the sensor is manufactured until the start of measurement.
Further, in patients who need insulin administration or medication, or in some operations, blood glucose levels are monitored in order to prevent an extreme increase or decrease in blood glucose levels, that is, continuous blood glucose level measurement is desired. In this case, if the puncture of the skin is repeated for each measurement, the mental pain is great, the operation is complicated and the operation is hindered, or it is necessary to secure personnel for measurement.

Therefore, an object of the present invention is to provide a biological information measuring method capable of continuously measuring accurate biological information while reducing the pain of the measurement subject.
In addition, another object of the present invention is to provide a biological information measuring device capable of continuously measuring accurate biological information while reducing the suffering of the subject.

As means for solving the above-mentioned problems, the first invention of the present invention is a first detection in which characteristic information is detected by a subcutaneous body fluid sensor that contacts a subject's subcutaneous body fluid and electrically detects predetermined property information. And second detection for detecting unique information from blood collected from the subject at the same time as the first detection step by a blood sensor that detects unique information related to the same characteristic as the characteristic information in contact with blood Calibrating and processing the characteristic information continuously detected by the subcutaneous body fluid sensor based on the process, the characteristic information obtained in the first detection process and the unique information obtained in the second detection process, A biological information measuring method comprising a calibration processing step for obtaining biological information.
In this measurement method, characteristic information detected by contacting a subcutaneous body fluid sensor with subcutaneous body fluid, and unique information detected by contacting a blood sample collected at the same time as the detection of the characteristic information with a blood sensor having high accuracy and stability Thus, calibration corresponding to the characteristics of the subcutaneous body fluid sensor at the time of measurement is performed. This calibration can be applied to characteristic information continuously detected by the same subcutaneous body fluid sensor. Therefore, continuous biological information can be obtained by performing calibration processing corresponding to the characteristics of the subcutaneous body fluid sensor at the time of use by one blood collection and a less painful subcutaneous body fluid sensor.
In this specification, “continuously detected by the subcutaneous body fluid sensor” means that the subcutaneous body fluid sensor punctured into the skin in the first detection step is maintained in the puncture state and the energized state in the first detection step is maintained. Thus, not only the biological information is detected over time in an analog manner after the first detection step, but also a plurality of biological information is detected digitally at predetermined time intervals.

Further, the second invention of the present invention provides a characteristic information detection unit for electrically detecting predetermined characteristic information from the subcutaneous body fluid by a subcutaneous body fluid sensor punctured under the measurement person's skin, and a blood sample collected by the measurement person A unique information detection unit that electrically detects unique information having the same characteristic as the characteristic information from the collected blood by a blood sensor that is contacted, and a process that calibrates and processes the characteristic information based on the unique information And output means for outputting the processing result of the processing means as biological information, wherein the processing means is configured to obtain characteristic information continuously detected by the same subcutaneous body fluid sensor based on a single unique information. It is a biological information measuring device that performs calibration and processing.
This device can obtain characteristic information obtained by bringing the subcutaneous body fluid sensor into contact with the subcutaneous body fluid by the characteristic information receiving unit, and obtain unique information obtained by bringing the blood sensor into contact with the collected blood by the unique information receiving unit. be able to. Moreover, the processing means can calibrate the characteristic information continuously detected by the same subcutaneous body fluid sensor based on the single unique information. Therefore, according to this apparatus, by the measurement method according to the first aspect of the present invention, the calibration process corresponding to the characteristics of the subcutaneous body fluid sensor at the time of use is continuously performed by one blood collection and the less painful subcutaneous body fluid sensor. Biometric information can be measured.

Further, a third invention of the present invention is the biological information measuring device according to the second invention, comprising a notification means capable of reporting a numerical abnormality when the processing result exceeds a predetermined numerical range.
According to this apparatus, for example, when measuring biological information continuously, it is possible to easily grasp the numerical value abnormality of the biological information without the measurer continuously monitoring the value of the biological information.

  ADVANTAGE OF THE INVENTION According to this invention, the biological information measuring method which can reduce a patient's suffering, and can measure accurate biological information continuously, and a biological information measuring method which reduces a patient's suffering and is accurate, and is measured continuously By providing a biometric information measuring apparatus that can perform, it is possible to collect more accurate biometric information in a desired amount more easily.

  1 and 2 show an embodiment of a biological information measuring apparatus according to the present invention. The measuring device 1 is a device that can measure a blood glucose level as biological information. The measuring device 1 includes a main body 3 and a belt 5 attached to the main body 3 in a ring shape that can be adjusted in length. The belt 5 is wrapped around an arm, an abdomen, a limb, etc. and fixed to the human body. It is possible to fix to.

The main body 3 is entirely covered with a rectangular parallelepiped case. The main body 3 incorporates a processing unit 71 (see FIG. 7) that includes a known CPU and, as appropriate, RAM, ROM, and the like. In addition, a display unit 7 and an operation unit 9 are provided on a surface (front side of the paper in FIG. 1) that faces the direction opposite to the human body when the measuring device 1 of the main body unit 3 is fixed to the human body by the belt 5. Yes. As shown in FIG. 1, the operation unit 9 includes a plurality of push buttons, and can input measurement subject information and instructions such as measurement start and display switching.
The display unit 7 corresponds to the output unit 79 shown in FIG. As shown in FIG. 7, the output unit 79 is not limited to a display unit that outputs visual information such as the display unit 7, but a sound generating unit that outputs biological information as auditory information such as a speaker, Alternatively, it is possible to provide communication means for outputting biological information as wired, electrical, magnetic, or optical information.

  As shown in FIG. 2, the main body unit 3 is provided with a characteristic information receiving unit 11 and a unique information receiving unit 23. The characteristic information receiving unit 11 is a part where the subcutaneous body fluid sensor 31 is attached and the characteristic information can be detected, and corresponds to the first input interface 73 shown in FIG. The unique information receiving unit 23 is a part to which the blood sensor 61 is attached and can detect the unique information, and corresponds to the second input interface 75 shown in FIG.

  The characteristic information receiver 11 is provided on the surface of the main body 3 that contacts the skin of the human body when the measuring device 1 is fixed to the human body by the belt 5. In this embodiment, as shown in FIG. 2, it is disposed inside the main body 3 and can hold the needle-like detection part 37 of the subcutaneous body fluid sensor 31 so as to extend substantially perpendicular to the human body contact surface. Is formed. The characteristic information receiving unit 11 can have a known configuration in which the subcutaneous body fluid sensor 31 can be detachably mounted and is electrically connected to the mounted subcutaneous body fluid sensor 31. For example, the characteristic information receiving unit 11 includes a plurality of terminals (not shown) and is configured in the same manner as a known connector.

  A movable member 13 is provided to switch the position of the subcutaneous body fluid sensor 31 mounted on the characteristic information receiving unit 11 between a standby state protected from the outside and a use state exposed to be punctured subcutaneously. As shown in FIG. 2, the movable member 13 is formed in a box shape with a small thickness and is movably connected to the main body 3 by a connecting member 18. The movable member 13 includes a through hole 16 through which the detection unit 37 of the subcutaneous body fluid sensor 31 can be inserted at the center of the human body contact surface. In this embodiment, the connecting member 18 includes a coil spring, and is normally held at a standby position in which the movable member 13 protrudes outward from the case constituting the main body 3 as shown in FIG. Yes. When the movable member 13 receives a predetermined force or more toward the center of the main body 3, the coil spring of the connecting member 18 contracts, and the movable member 13 is attached to the characteristic information receiving unit 11 as shown in FIG. 6. The detection unit 37 of the subcutaneous body fluid sensor 31 can be moved to a detection position located in the main body 3 rather than the tip of the detection unit 37.

  Further, in the measuring apparatus 1, a load adding member is provided as a means for expanding and contracting the connecting member 18. In this embodiment, the load adding member includes an airbag 20 provided inside the ring of the belt 5 as shown in FIGS. The airbag 20 is deformed from the state shown in FIG. 2 to the inflated state as shown in FIG. 6, for example, by supplying a predetermined amount of air to the inside via an air pump, an air valve, etc. (not shown). Due to this deformation, the cross-sectional area of the airbag 20 in the wound belt 5 increases, and a stronger pressure is applied to the belt 5 and the movable member 13 through the human body. Therefore, when the pressure becomes greater than a predetermined level, the coil spring of the connecting member 18 is compressed, and the movable member 13 moves from the standby position to the detection position. The load applying member using the airbag 20 can stably apply a predetermined force or more toward the center of the main body 3 to the movable member 13 in a state where the measuring device 1 is fixed to the human body.

  The unique information receiving unit 23 may be provided in any part of the measuring apparatus 1. In the present embodiment, as shown in FIGS. 1 and 2, the main body 3 is provided on the side where the belt 5 is attached. The unique information receiving unit 23 includes a mounting unit (not shown) to which the blood sensor 61 can be detachably mounted. The mounting portion includes a plurality of terminals that can be electrically connected to the mounted blood sensor 61, and is configured in the same manner as a known connector.

Next, an embodiment of the subcutaneous body fluid sensor 31 and the blood sensor 61 attached to the measuring apparatus 1 will be described.
As shown in FIG. 3, the subcutaneous body fluid sensor 31 includes a plate-shaped base material 33. On the base material 33, a detection unit 37 including two electrode portions 41 and 42 protruding like a needle, and lot information And an identification unit 39 having the same. Further, as shown in FIG. 5, the blood sensor 61 includes a plate-like base material 63, and is disposed on the base material 63 so as to be adjacent to each other, and two electrode portions 65 and 66 formed flat, respectively. And a detector 67 having lot information. Since the subcutaneous body fluid sensor 31 and the blood sensor 61 have substantially the same configuration, the subcutaneous body fluid sensor 31 will be described below, and the blood sensor 61 will be supplemented only for points different from the subcutaneous body fluid sensor 31.

The base material 33 is formed of an insulating material. For example, it can be formed of ceramic, resin, paper (pulp), a laminated material of a wood material, or the like.
The detection unit 37 includes electrode units 41 and 42 that can come into contact with the subcutaneous body fluid, and a wiring unit 44 that electrically connects the electrode units 41 and 42 to the characteristic information receiving unit 11 independently of each other. The base portion 46 (see FIG. 4) and the wiring portion 44 of each of the electrode portions 41 and 42 are made of a conductive member. For example, it can be formed of copper, and the wiring portion 44 can be formed by printing on the base material 33 by a known method.

  The base portion 46 of the electrode portions 41 and 42 is preferably made of a noble metal material, and for example, platinum, gold or the like is preferable. The base 46 of the subcutaneous body fluid sensor 31 is formed in a conical shape in advance and is attached to the base member 33 in a state of being electrically connected to the wiring portion 44. In the form shown in FIG. 4, the through hole 35 is provided in the base material 33 in advance, and the wiring portion 44 is provided so as to cover the inner peripheral surface of the through hole 35 and the base material 33 around the through hole 35. The base portion 46 is provided with a cylindrical mounting portion 47 that is conical and protrudes from the bottom surface thereof. The base portion 46 is soldered in a state in which the mounting portion 47 is inserted into the through hole 35 and is in contact with the wiring portion 44. 33 is fixed. The size of the subcutaneous body fluid sensor 31 is not particularly limited, but the length in the puncture direction is 1 mm or less and the maximum diameter is 0.5 mm or less from the viewpoint of pain reduction and sensitivity maintenance.

  As shown in FIG. 4, the electrode units 41 and 42 are provided with a selection unit 48 for obtaining information on predetermined biological characteristics, that is, characteristic information. The selection unit 48 is a part for selectively extracting characteristic information regarding the characteristics of the subcutaneous body fluid such as the concentration and presence / absence of a predetermined component from the subcutaneous body fluid in which various components are mixed. The selection unit 48 can have various configurations such as an enzyme that reacts with a specific substance or a limited permeable membrane that does not transmit or transmit only a specific substance. In the subcutaneous body fluid sensor 31 of the present embodiment that measures a blood glucose level, the selection unit 48 can be a site containing glucose oxidase that selectively undergoes an electron transfer reaction with sugar. The selection part 48 can be formed in a film shape that covers the base part 46 of the electrode parts 41 and 42.

Here, the strength of the electron transfer reaction in the selection unit 48 using the enzyme reaction and the potential applied to the electrode units 41 and 42 may be significantly different. In this case, it is preferable to provide an electron mediator that compensates for the potential difference. For example, various ferrocenes can be used for the selection unit 48 containing glucose oxidase. For example, a ferrocenecarboxaldehyde-albumin covalent conjugate is preferable. The electrode portions 41 and 42 shown in FIG. 4 are provided with an electron mediator portion 50 that covers the outside of the selection portion 48.
The electron mediator may be provided in the selection unit 48 in a mixed state.

  Further, it is preferable that a protective part 52 is provided on the surface of the subcutaneous body fluid sensor 31. The protection unit 52 can transmit a component related to the characteristic information and has various protection functions. As a protective function, suppression of component elution from the subcutaneous body fluid sensor 31, suppression of adhesion of proteins and fats in the subcutaneous body fluid, or suppression of contact of a component that inhibits the function of the selection unit 48 with the selection unit 48. Etc. This suppresses the occurrence of adverse effects such as allergic reaction to the living body by puncturing the electrode portions 41 and 42 under the skin, and maintains the detection sensitivity of the characteristic information. Examples of such a protection unit 52 include a film that covers the entire outer surface of the detection unit 37 including the electrode units 41 and 42 and that uses 2-methacryloyloxyethyl-phosphorylcholine (MPC). it can. MPC has high biocompatibility and is difficult to adhere to components in subcutaneous body fluids such as proteins.

The blood sensor 61 is the same as the subcutaneous body fluid sensor 31, but the electrode portions 65 and 66 may have any shape that can satisfactorily contact the collected blood. good. In the blood sensor 61 shown in FIG. 5, the electrode portions 65 and 66 are formed of the same foil as that of the wiring portion 64, and a rectangular portion having a surface area larger than that of the wiring portion 64 and three of the rectangular portions. It is formed in a U-shaped part surrounding the outer periphery of the side. This portion may be formed of a noble metal material, or may be formed of copper foil or carbon, like the electrode portions 41 and 42 of the subcutaneous body fluid sensor 31. In the vicinity of the electrode portions 65 and 66, it is preferable that blood is easily adapted. For example, the base material 63 is preferably formed of a water-absorbing material such as paper.
Further, at least a selection unit and an electron mediator are provided on the surfaces of the electrode units 65 and 66. In addition, the protection unit does not have to consider biocompatibility. However, in the case where impurities such as proteins in the blood hinder or affect the detection of specific information related to a predetermined characteristic, It is preferable to provide a material that can remove the adverse effect on selecting information.

The identification unit 39 is a part that holds the lot information so that it can be read by the characteristic information receiving unit 11. In the form shown in FIG. 3, the wiring is formed by a plurality of wirings formed by printing a copper foil, and the wirings can be electrically connected to the terminals of the characteristic information receiving unit 11. The identification unit 69 of the blood sensor 61 can also have the same configuration.
Here, the lot information may be a signal indicating the lot, a coefficient used when processing the characteristic information or unique information detected by the subcutaneous body fluid sensor 31 or the blood sensor 61 in the processing means 71, or the arithmetic expression itself. It may be. In particular, the lot information of the subcutaneous body fluid sensor 31 is not limited to the raw material supply destination and the manufacturing time, and includes information indicating the exposure condition of the subcutaneous body fluid sensor 31 such as information indicating a distribution route and a delivery destination.

  Here, the processing means 71 of the measuring apparatus 1 will be described with reference to FIG. The processing means 71 of this embodiment processes the characteristic information received from the first input interface 73 (characteristic information receiving unit 11) to obtain biological information, that is, a blood sugar level, and the second input interface 75 (specific information reception). And 23) processing the unique information received from the processing unit 23) to obtain a blood sugar level. Further, the processing means 71 calibrates the processing of the characteristic information based on the unique information obtained from the second input interface 75, that is, the biological information obtained by processing the unique information, and more accurate blood glucose from the characteristic information. The value can be determined. Furthermore, two or more pieces of characteristic information are continuously received from the first input interface 73 (characteristic information receiving unit 11), and the blood glucose level can be obtained by processing the characteristic information by a calibrated process. Moreover, the obtained blood glucose level information can be transmitted to the output interface 77, and the measurer can acquire the biological information by the output means 79.

  Further, as shown in FIG. 7, the measuring device 1 can be appropriately provided with a storage unit 81. The storage unit 81 stores rewritable lot information held in the identification unit 39 of the subcutaneous body fluid sensor 31 attached to the characteristic information receiving unit 11.

Next, a method for measuring a blood glucose level, which is biological information, using the measuring device 1 will be described.
First, the subcutaneous body fluid sensor 31 is attached to the characteristic information receiving unit 11 of the measuring apparatus 1, and the blood sensor 61 is attached to the unique information receiving unit 23. Lot information held in the identification unit 69 of the subcutaneous body fluid sensor 31 and the blood sensor 61 can be read by the characteristic information receiving unit 11 and the unique information receiving unit 23 by wearing or by an operation such as turning on the power of the measuring device 1. It becomes. If necessary, the processing means 71 (see FIG. 7) detects the lot information at this time, and enables processing corresponding to the lot information.

  The blood glucose level measuring method by the measuring device 1 includes a first detection step, a second detection step, and a calibration processing step. The first detection step and the second detection step are performed at the same time, that is, in a time range in which the change in characteristics in the living body can be ignored. Further, the first detection step and the second detection step may be performed in this order, or the second detection step may be performed before the first detection step. Moreover, it may be performed simultaneously, and when a predetermined time is required for detecting correct information, the time can be shortened.

(First detection step)
In the first detection step, the subcutaneous body fluid sensor 31 is punctured subcutaneously and the detection body 37 is brought into contact with the subcutaneous body fluid. In the measuring apparatus 1, first, the main body 3 is fixed to the skin by winding the belt 5 around the biological arm 100 or the like. Next, air is sent into the airbag 20 to inflate the airbag 20 so that a predetermined pressure is obtained. When the predetermined pressure is reached, the movable member 13 moves to the detection position toward the center of the main body 3. As a result, as shown in FIG. 6, the distal end of the detection unit 37 of the subcutaneous body fluid sensor 31 attached to the measuring device 1 is exposed from the main body unit 3 and punctured under the arm 100. When the detection unit 37 of the subcutaneous body fluid sensor 31 comes into contact with the subcutaneous body fluid, the property information can be detected by the property information receiving unit 11 (first input interface 73), and the processing unit 71 can receive the property information. it can.

(Second detection step)
In the second detection step, blood collected from the measurement subject by an arbitrary method is brought into contact with the detection unit 67 of the blood sensor 61. When blood sensor 61 comes into contact with blood, unique information can be detected by unique information receiving unit 23 (second input interface 75), and processing means 71 can receive unique information. The processing means 71 receives the unique information or processes the unique information by a method corresponding to the lot information of the blood sensor 61 in a calibration processing step to be described later, thereby obtaining biological information, that is, a blood glucose level.

  When the blood glucose level is obtained from the unique information, the processing unit 71 transmits the processing result (blood glucose level) to the output unit 79 via the output interface 77. The output means 79 outputs this to the outside. In the measuring apparatus 1, for example, the blood glucose level, which is biological information, is displayed on the display unit 7, and the measurer can recognize the processing result.

The continuous detection of characteristic information is performed after the first detection step while maintaining the subcutaneous body fluid sensor 31 in the punctured state, that is, the detected state shown in FIG. The continuous detection of the characteristic information is performed at predetermined time intervals or continuously for a predetermined period.

  Next, the obtained characteristic information is processed by the processing means 71 using calibration based on the characteristic information obtained in the first detection step and the unique information obtained in the second detection step. Here, the reason why calibration is required will be described. Since the subcutaneous body fluid sensor 31 has a large change in sensor characteristics due to exposure conditions and time, the subcutaneous body fluid sensor 31 at the time of measurement after transportation, storage, etc. may have sensor characteristics different from those immediately after manufacture. For this reason, the processing held in the processing means 71, that is, the conversion formula of characteristic information into blood glucose level (including the formula corrected by lot information) does not necessarily correspond to the sensor characteristic of the subcutaneous body fluid sensor 31, Large biological information (blood glucose level) may be obtained. In order to avoid this, the measuring apparatus 1 performs calibration.

  The calibration can be performed by a known method based on the blood glucose level at the start of measurement obtained from the blood sensor 61 that maintains more stable accuracy depending on the exposure conditions and the passage of time. For example, the processing means 71 processes the characteristic information at the start of measurement obtained from the subcutaneous body fluid sensor 31, and corrects the portion related to the sensor characteristic in the conversion formula so that the same blood glucose level as the blood sensor 61 is obtained. By correcting the portion related to the sensor characteristics, the characteristic information continuously detected can be processed by the same calibration process to obtain highly accurate biological information with few errors. Of course, in the processing of the characteristic information by the processing means 71, processing corresponding to the identification information obtained from the identification unit 39 of the subcutaneous body fluid sensor 31 can be performed.

  When the processing unit 71 continuously receives the characteristic information, the processing unit 71 calibrates the characteristic information and transmits the processing result to the output unit 79 via the output interface 77. The output unit 79 outputs biological information or the like that is a processing result. In addition, a process result is not limited only to a blood glucose level. For example, it can be the amount of insulin to be administered or the amount of blood-lowering agent calculated based on the person-to-be-measured information input in advance by the operation unit 9. Further, the processing means 71 may determine whether or not the blood glucose level is in a numerical range, and the determination result may be used. For example, the determination result may be transmitted to the output unit 79 only when it is out of the numerical value range and recognized by the measurer. In this case, it is preferable that the output means 79 is a sound generating means such as a speaker, since it can be easily recognized even if the measurer is away from the measuring apparatus 1.

  When the measurement is finished, the air inside the airbag 20 is discharged to reduce the force applied to the movable member 13. When this force is reduced and the spring force of the coil spring of the connecting member 18 is won, the movable member 13 moves from the detection position to the standby position, and the detection unit 37 of the subcutaneous body fluid sensor 31 comes out of the skin. Thereafter, the belt 5 is removed from the arm 100.

  According to this measuring apparatus 1, except that blood is collected at the start of measurement, the blood glucose level can be continuously measured with high accuracy by maintaining the state in which the subcutaneous body fluid sensor 31 is punctured subcutaneously and the energized state. it can. For this reason, the physical pain and the mental pain of the measurement subject can be reduced, and the temporal change of the blood glucose level of the measurement subject can be measured. In addition, the labor of the measurer is reduced. Further, if the processing means 71 determines the numerical range and the output means 79 notifies that the numerical value is out of the numerical range, the restraint of the measurer while measuring the blood glucose level is greatly reduced. A large amount of blood glucose level information can be easily obtained. Therefore, in this measuring apparatus 1, a patient's burden can be eased and a blood glucose level can be measured continuously, and an excessive rise and fall of a blood glucose level can be quickly detected and dealt with. For example, it is possible to easily measure the blood glucose level of a diabetic patient before and after a meal, medication, or insulin administration, or monitor the blood glucose level of a patient during surgery.

The present invention is not limited to the above embodiment.
The electrodes of the subcutaneous body fluid sensor and the blood sensor are not limited to two, and may be three. In two cases, a counter electrode and a working electrode, and in three cases, a reference electrode is further added.
The structure and shape of the subcutaneous body fluid sensor and the blood sensor are not limited to a plate shape, and can take various shapes. In addition, the structure and shape of the characteristic information receiving unit and the unique information receiving unit can be changed in accordance with the structure and shape of the sensor.
In addition, neither the blood sensor nor the subcutaneous body fluid sensor need be provided with an identification unit. The identification unit is not limited to electrical information, and can take a known information form such as optical and magnetic information. That is, the characteristic information receiving unit and the unique information receiving unit of the measuring apparatus are not limited to the connector as a part for receiving the lot information, and may be known information receivers such as optical and magnetic.

The biological information is not limited to the blood glucose level. Various biological information that can be electrically detected using a predetermined film or the like can be obtained.
The biological information measuring device is not limited to the shape of the present embodiment, and the characteristic information receiving unit and / or the specific information receiving unit is connected to the part including the processing unit and the output unit by wiring or the like, and moves more freely. It may be provided. Alternatively, these receiving units may be substantially separated and connected to the processing means so as to be able to transmit characteristic information or unique information by a known wireless connection method. In particular, in a measuring device capable of continuously measuring biological information with a single subcutaneous body fluid sensor, the characteristic information receiving unit is preferably in a form that can be fixed to a human body. The form which is not fixed may be sufficient. Alternatively, the output unit 79 may be provided separately from the processing unit 71 so that biological information can be recognized at a remote place.
Further, in the measuring apparatus 1, the characteristic information receiving unit 11 may be provided so as to be movable so that it can be switched between a standby state and a use state (puncture state) of the subcutaneous body fluid sensor. The movement structure related to switching between the standby position and the detection position of the subcutaneous body fluid sensor is not limited to a configuration using an elastic member such as a coil spring or an air cylinder. For example, a known movement such as a configuration using a rack and pinion is used. Possible configurations can be obtained.
In addition, the configuration according to the present invention may be applied to a known blood glucose meter or biological information measuring device having a structure different from that of the measuring device 1, and the biological information may be measured by the method according to the present invention. is there.

It is a top view which shows one Embodiment of the biometric information measuring apparatus which concerns on this invention. It is the side view which fractured | ruptured a part of biological information measuring device of FIG. It is a perspective view which shows an example of a subcutaneous body fluid sensor with which the biological information measuring device of FIG. 1 is mounted | worn. FIG. 4 is a partial side sectional view of the subcutaneous body fluid sensor of FIG. 3. It is a perspective view which shows an example of the blood sensor with which the biological information measuring device of FIG. 1 is mounted | worn. It is a schematic diagram which shows the use condition when measuring biometric information using the biometric information measuring apparatus of FIG. It is a block diagram which shows the flow of information when a subcutaneous body fluid sensor and a blood sensor are mounted | worn with the biological information measuring device which concerns on FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Measuring apparatus 3 Main body part 5 Belt 7 Display part 9 Operation part 11 Characteristic information receiving part 13 Movable member 16 Through-hole 18 Connecting member 20 Airbag 23 Specific information receiving part 31 Subcutaneous body fluid sensor 33, 63 Base material 35 Through-hole 37, 67 Detection part 39, 69 Identification part 41, 42, 65, 66 Electrode part 44, 64 Wiring part 46 Base part 47 Attachment part 48 Selection part 50 Electronic mediator part 52 Protection part 61 Blood sensor 71 Processing means 73 1st input interface 75 1st 2-input interface 77 Output interface 79 Output means 81 Storage means 100 Arm

Claims (3)

A first detection step of detecting characteristic information by a subcutaneous body fluid sensor that contacts a subject's subcutaneous body fluid and electrically detects predetermined characteristic information;
A second detection step of detecting the unique information from the blood collected from the subject at the same time as the first detection step by a blood sensor that detects unique information related to the same property as the property information in contact with the blood;
A calibration processing step of obtaining predetermined biological information from the characteristic information continuously detected by the subcutaneous body fluid sensor by calibration based on the characteristic information obtained in the first detection step and the unique information obtained in the second detection step; A biological information measuring method comprising: A characteristic information detector that electrically detects predetermined characteristic information from the subcutaneous body fluid by a subcutaneous body fluid sensor that is punctured under the skin of the measurement subject;
A unique information detector that electrically detects unique information having the same characteristics as the characteristic information from the collected blood by a blood sensor that is in contact with the collected blood of the measurement subject;
Processing means for calibrating and processing the characteristic information based on the unique information;
Output means for outputting the processing result of the processing means as biological information,
The biological information measuring apparatus, wherein the processing means calibrates and processes characteristic information continuously detected by the same subcutaneous body fluid sensor based on a single unique information. The biological information measuring apparatus according to claim 2, further comprising a notification unit capable of reporting a numerical abnormality when the processing result exceeds a predetermined numerical range.

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