WO2018047842A1 - Sonde destinée à être utilisée dans la mesure d'informations biologiques, et dispositif de mesure d'informations biologiques - Google Patents

Sonde destinée à être utilisée dans la mesure d'informations biologiques, et dispositif de mesure d'informations biologiques Download PDF

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Publication number
WO2018047842A1
WO2018047842A1 PCT/JP2017/032038 JP2017032038W WO2018047842A1 WO 2018047842 A1 WO2018047842 A1 WO 2018047842A1 JP 2017032038 W JP2017032038 W JP 2017032038W WO 2018047842 A1 WO2018047842 A1 WO 2018047842A1
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WIPO (PCT)
Prior art keywords
biological information
dielectric layer
probe
electrode layer
information measuring
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PCT/JP2017/032038
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English (en)
Japanese (ja)
Inventor
雅史 太田
侑亮 別所
朗 石川
暁生 山本
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バンドー化学株式会社
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Publication of WO2018047842A1 publication Critical patent/WO2018047842A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/113—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb occurring during breathing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor

Definitions

  • the present invention relates to a biological information measuring probe and a biological information measuring apparatus provided with the biological information measuring probe.
  • Patent Document 1 discloses a potential difference measuring unit that measures a potential difference between a plurality of electrodes using a plurality of electrodes arranged on a user's chest.
  • An impedance measurement unit that measures the impedance between the plurality of electrodes, obtains an electrocardiogram of the user based on the potential difference measured by the potential difference measurement unit, and measures temporal variations in impedance measured by the impedance measurement unit.
  • a biological signal measuring device that acquires user's respiration information based on this is disclosed.
  • the present inventors have completed a new biological information measuring probe that can simultaneously acquire an electrocardiogram and respiratory information even when the subject is moving.
  • a biological information measuring apparatus provided with this biological information measuring probe was also completed.
  • the present inventors use not only a combination of an electrocardiogram and respiratory information, but also an electrical biological signal (biological potential) such as a myoelectric potential other than a cardiac potential, a brain potential (electroencephalogram), It is also possible to simultaneously acquire information on the movement of the living body surface (for example, skin stretch).
  • the present inventors have made it possible to give information on the movement of the living body surface (for example, skin stretch) caused by the stimulation while applying electrical stimulation to the living body by the probe for measuring biological information. .
  • the probe for biological information measurement of the present invention A sheet-like first dielectric layer made of an elastomer composition and a conductive composition containing a conductive material, and at least sandwiching the first dielectric layer between the front surface and the back surface of the first dielectric layer A first electrode layer and a second electrode layer that are formed so as to face each other, wherein the opposing portions of the first electrode layer and the second electrode layer serve as detection portions, and the front and back areas of the dielectric layer A capacitance detection sheet that reversibly deforms so as to change, An external electrode provided on the back side of the capacitance detection sheet with an insulating layer in contact with the biological surface; It is characterized by providing.
  • the biological information measuring probe of the present invention includes the capacitance detection sheet and the external electrode. For this reason, by using the biological information measuring probe attached to a living body so that the external electrode is in contact with the surface of the living body, bioelectric potentials such as cardiac potential, myoelectric potential, and brain potential (electroencephalogram) are applied to the external electrode. And the state of deformation (elongation / atrophy, expansion / contraction, etc.) of the living body surface can be tracked via the capacitance detection sheet. At this time, the measurement of the bioelectric potential such as the cardiac potential and the tracking of the deformation state of the biological surface can be performed simultaneously. Therefore, by using the biological information measuring probe, it is possible to simultaneously acquire two types of biological information, that is, a biological potential and a deformation state of the biological surface.
  • the external electrode is preferably deformable following the deformation of the dielectric layer and has adhesiveness.
  • the biological information measuring probe can be attached to the surface of the living body by utilizing the adhesiveness of the external electrode.
  • the external electrode may be provided at a position overlapping the detection portion of the capacitance detection sheet in the thickness direction. it can.
  • the capacitance detection sheet further includes a sheet-like second dielectric layer made of an elastomer composition, and a third electrode layer made of a conductive composition containing a conductive material,
  • the second dielectric layer is laminated on the front side of the first dielectric layer so as to cover the first electrode layer formed on the front surface of the first dielectric layer,
  • the third electrode layer is preferably formed on the front surface of the second dielectric layer so that at least a part of the third electrode layer faces the first electrode layer with the second dielectric layer interposed therebetween.
  • the biological information measuring probe is preferably used for acquiring an electrocardiogram and a respiratory state.
  • the electrocardiogram and the respiratory state of the subject can be acquired even when the subject is active.
  • the biological information measuring probe is preferably used for acquiring an electromyogram and a contraction state of a muscle. By using the biological information measuring probe, changes in myoelectric potential and muscle contraction can be acquired simultaneously.
  • the biological information measuring device of the present invention is The biological information measuring probe of the present invention; Measuring instruments, A biological information measuring device comprising: Including one or more biological information measuring probes so that the total number of external electrodes provided in the biological information measuring probe is plural, The measuring device measures a capacitance in the detection unit and measures a potential difference between the external electrodes.
  • the biological information measuring apparatus of the present invention includes the biological information measuring probe, it can simultaneously acquire two types of biological information, that is, a biological potential and a deformation state of the biological surface.
  • the present invention two types of biological information, that is, the bioelectric potential and the deformation state of the biological surface can be acquired simultaneously. Further, the present invention is suitable for acquiring the biological information even when the subject is active.
  • FIG.2 (a) is a perspective view which shows typically an example of the electrostatic capacitance detection sheet
  • FIG.2 (b) is FIG.2 (a).
  • FIG. FIGS. 3A to 3B are diagrams schematically showing an example of the biological information measuring probe according to the embodiment of the present invention.
  • 3A is a plan view
  • FIG. 3B is a back view
  • FIG. 3C is a cross-sectional view taken along line BB in FIG. 3B. It is a figure for demonstrating an example of the usage method of the probe for biological information measurement which concerns on embodiment of this invention.
  • FIG. 5A and 5B are diagrams schematically showing another example of the biological information measuring probe according to the embodiment of the present invention.
  • 5A is a rear view
  • FIG. 5B is a cross-sectional view taken along the line CC of FIG. 5A.
  • FIG. 6A is a perspective view schematically showing another example of the capacitance detection sheet constituting the biological information measuring probe according to the embodiment of the present invention, and
  • FIG. It is the DD sectional view taken on the line of a).
  • It is a figure for demonstrating the mounting position of the probe for biological information measurement in Example 1.
  • FIG. is a figure which shows the measurement result in Example 1.
  • FIG. It is a figure which shows the measurement result in Example 2.
  • FIG. 1 is a schematic diagram illustrating an example of a biological information measuring apparatus according to the present embodiment.
  • FIG. 2A is a perspective view schematically showing an example of a capacitance detection sheet constituting the biological information measuring probe according to the present embodiment
  • FIG. 2B is a diagram A of FIG.
  • FIGS. 3A to 3B are diagrams schematically showing an example of the biological information measuring probe according to the present embodiment, in which FIG. 3A is a plan view, FIG. 3B is a back view, FIG. 3C is a cross-sectional view taken along the line BB of FIG.
  • the side on which the external electrode is provided is referred to as the back side
  • the opposite side in the thickness direction is referred to as the front side.
  • the biological information measuring apparatus 1 includes a biological information measuring probe (hereinafter simply referred to as a probe) 2 according to the present embodiment and a measurement that is electrically connected to the probe 2. And a display device 4 for displaying the measurement result of the measuring device 3.
  • the probe 2 is composed of a capacitance detection sheet 10 and an insulating material laminated on both surfaces (front surface and back surface) of the capacitance detection sheet 10.
  • the covering member 21 and one external electrode 24 provided on the back side of the capacitance detection sheet 10 via the covering member 21 are provided.
  • the biological information measuring apparatus 1 is configured such that the total number of external electrodes 24 included in the probe 2 is plural for the entire biological information measuring apparatus 1. Therefore, the biological information measuring device 1 includes at least two probes 2. Note that the number of probes 2 may be appropriately selected according to the measurement target.
  • the capacitance detection sheet 10 includes a sheet-like dielectric layer 11 made of an elastomer composition, and a front electrode layer formed on the front surface of the dielectric layer 11. 12A, a back electrode layer 12B formed on the back surface of the dielectric layer 11, a front wire 13A connected to the front electrode layer 12A, a back wire 13B connected to the back electrode layer 12B, and a front electrode of the front wire 13A 14 A of front side connection parts attached to the edge part on the opposite side to layer 12 A, back side connection part 14 B attached to the edge part on the opposite side to back side electrode layer 12 B of back side wiring 13 B, and the front side and back side of dielectric layer 11 A front-side protective layer 15A and a back-side protective layer 15B that are laminated on each other are provided.
  • Lead wires 22 are connected to the front side connection portion 14A and the back side connection portion 14B (see FIGS. 3A to 3C), and the capacitance detection sheet 10 is connected to the measuring instrument
  • the front-side electrode layer 12A and the back-side electrode layer 12B have the same plan view shape, and the front-side electrode layer 12A and the back-side electrode layer 12B face each other across the dielectric layer 11.
  • a portion where the front electrode layer 12A and the back electrode layer 12B face each other serves as a detection unit.
  • the front-side electrode layer and the back-side electrode layer provided in the capacitance detection sheet do not necessarily have to face each other across the dielectric layer.
  • the front side electrode layer and the back side electrode layer may be at least partially opposed to each other.
  • the front electrode layer 12A corresponds to the first electrode layer
  • the back electrode layer 12B corresponds to the second electrode layer.
  • the dielectric layer 11 since the dielectric layer 11 is made of an elastomer composition, it can be deformed (stretched) in the surface direction.
  • the front-side electrode layer 12A and the back-side electrode layer 12B, and the front-side protective layer 15A and the back-side protective layer 15B (hereinafter simply referred to as the protective layer together) Also called).
  • the capacitance detection sheet 10 As the capacitance detection sheet 10 is deformed, the capacitance of the detection unit changes in correlation with the amount of deformation of the dielectric layer 11 (area change of the electrode layer). Therefore, the deformation amount of the capacitance detection sheet 10 can be detected by detecting the change in the capacitance of the detection unit.
  • the two covering members 21 (21A, 21B) are respectively laminated on the front side and the back side of the capacitance detection sheet 10 via an adhesive layer (not shown).
  • the two covering members 21 (21A, 21B) are cloth fabrics having stretch anisotropy, and are laminated so as to cover the entire capacitance detection sheet 10 when the probe 2 is viewed in plan.
  • the covering member 21 having expansion / contraction anisotropy easily expands and contracts in the longitudinal direction of the capacitance detection sheet 10 (left and right direction in FIGS. 3A and 3B), and is perpendicular to the longitudinal direction (width direction). ) Is a member that is difficult to expand and contract.
  • the capacitance detection sheet 10 contracts in the width direction as the extension amount increases. This can be suppressed.
  • the capacitance of the detection unit increases according to the amount of expansion of the capacitance detection sheet 10, and the correlation (proportional relationship) between the amount of expansion and the capacitance is It is also maintained when the amount of expansion of the capacitance detection sheet 10 increases or when the capacitance detection sheet is repeatedly expanded and contracted. Therefore, by using the probe 2, the extension amount of the detection unit can be measured with high sensitivity and high accuracy.
  • the external electrode 24 is provided on the back side of the covering member 21B.
  • the external electrode 24 is provided so that the size in plan view is larger than the size in plan view of the detection unit and overlaps the entire detection unit in the thickness direction.
  • the external electrode 24 is configured to be deformable following the deformation of the dielectric layer 11 (the detection unit).
  • the external electrode 24 has adhesiveness and is configured so that the probe 2 can be attached to the surface of the living body. Therefore, the external electrode 24 is formed using a hydrogel having conductivity and adhesiveness.
  • an electrical terminal 23 connected to the lead wire 25 is attached to one end side in the surface direction of the external electrode 24 (right side in FIG. 3B).
  • the electric terminal 23 is attached between the external electrode 24 and the covering member 21B so as to be sandwiched therebetween.
  • the external electrode 24 is connected to the measuring instrument 3 by a lead wire 25. Therefore, the bioelectric potential can be measured by attaching a plurality of probes 2 to the surface of the living body and measuring the potential difference between the external electrodes 24 included in the probe 2.
  • the measuring instrument 3 measures a potential difference between a circuit (hereinafter, also referred to as a capacitance measuring circuit) 3A for measuring the capacitance of the detection unit in the capacitance detection sheet 10 and a plurality of external electrodes 24.
  • Circuit hereinafter also referred to as a biopotential measurement circuit
  • the capacitance measuring circuit 3A is, for example, a circuit combining a Schmitt trigger oscillation circuit for converting capacitance into a frequency signal and an F / V conversion circuit for converting the frequency signal into a voltage signal.
  • the capacitance measuring circuit 3A converts the capacitance detected by the detection unit of the biological information measuring probe 2 into a frequency signal, further converts it into a voltage signal, and transmits it to the display 4.
  • the configuration of the capacitance measuring circuit 3A is not limited to such a configuration.
  • the biopotential measurement circuit 3B may be any circuit as long as it is a circuit that can measure a potential difference between the plurality of external electrodes 24.
  • the biopotential measurement circuit 3B transmits the measured potential difference to the display 4 as a voltage signal.
  • the display 4 includes a monitor 4a, an arithmetic circuit 4b, and a storage unit 4c.
  • the display 4 displays on the monitor 4a the time change of the capacitance of the detection unit measured by the measuring device 3, and the storage unit 4c stores the change in the capacitance as recording data.
  • the display 4 displays on the monitor 4a changes in potential difference between the plurality of external electrodes 24 measured by the measuring instrument 3, and the storage unit 4c stores the changes in potential difference as recording data.
  • the display 4 calculates the deformation amount of the living body surface by the arithmetic circuit 4b based on the voltage signal related to the capacitance of the detection unit received from the measuring instrument 3, and displays the deformation amount on the monitor 4a as the deformation amount of the living body surface. Also good.
  • the biological information measuring apparatus 1 is used by attaching the probe 2 to a biological surface (human or animal skin) so that the external electrode 24 of the probe 2 is in contact with the biological surface.
  • the external electrode 24 also functions as an adhesive layer for attaching the probe 2 to the biological surface.
  • the capacitance detection sheet expands and contracts following the deformation (elongation / atrophy, expansion / contraction, etc.) of the living body surface.
  • the capacitance of the detection unit changes. Therefore, the biological information measuring apparatus 1 can measure the deformation amount of the biological surface by measuring the capacitance of the detection unit.
  • the bioelectric potential corresponding to the position where the probe 2 is attached can be measured.
  • FIG. 4 is a diagram for explaining an example of a method of using the probe (biological information measurement device) according to the present embodiment.
  • two probes 2 ⁇ / b> A and 2 ⁇ / b> B are attached to the upper arm surface.
  • the two probes 2A and 2B are attached in such a direction that the longitudinal direction of the capacitance detection sheet is substantially perpendicular to the direction of the muscle fibers of the biceps (the direction from the shoulder to the hand). Further, the two probes 2A and 2B are attached so as to be separated from each other.
  • the probes 2A and 2B are connected to the measuring instrument and the display.
  • the biological information measuring apparatus can simultaneously measure a change in myoelectric potential due to muscle movement and a deformation state of the biological surface.
  • the obtained measurement results can be used for analysis of the subject's motor function. Further, the obtained analysis result can be fed back to the diagnosis of the health condition of the subject, creation of a rehabilitation menu, and the like.
  • the biological information measuring device can also be used, for example, to simultaneously acquire the subject's electrocardiogram and respiratory state.
  • the electrocardiogram for obtaining an electrocardiogram can be measured by attaching the external electrode 24 of the probe 2 as an electrocardiogram electrode.
  • the respiration information (respiration rate and respiration depth) of the subject can be acquired by measuring the deformation state of the living body surface at the position where each probe is attached. In particular, by sticking the probe 2 to a part between the lower ribcage and the lower abdomen, the deformation state of the surface of the living body of this part can be measured with the capacitance detection sheet. Therefore, the respiratory rate etc. can be measured suitably.
  • transformation state of a biological body surface is measured, and respiration information is acquired based on this measurement result. Therefore, unlike the conventional method, it is less affected by body movement than when measuring the respiration rate based on the impedance between the electrodes, and the respiration rate can be measured even when the subject is moving. it can.
  • the attachment position of the probe 2 may be the same as the attachment position of a known electrocardiogram electrode.
  • the probe 2 attached on the left anterior axillary line is preferably used as the probe 2 for measuring the respiratory rate.
  • the external electrode 24 can be used as an electrocardiogram (ECG) electrode or an electromyogram (EMG) electrode.
  • ECG electrocardiogram
  • EMG electromyogram
  • EEG electroencephalogram
  • the external electrode 24 of the probe 2 can also be used as, for example, a transdermal peripheral nerve electrical stimulation (TENS) electrode, an electrical muscle stimulation (EMS) electrode, or the like.
  • TENS transdermal peripheral nerve electrical stimulation
  • EMS electrical muscle stimulation
  • the deformation state (movement) of the surface of the living body when an electrical stimulus is applied to the living body can be measured. Therefore, for example, it can be evaluated whether or not the muscle reacts normally when electrical stimulation is applied to the muscle.
  • the probe 2 may be used by being attached to a predetermined position on the surface of the living body according to the use of the external electrode 24.
  • the probe 2 (biological information measuring device 1) can be used for measuring the deformation state of the living body surface as described above. For this reason, it is possible to acquire information on biological activity (biological activity information) that correlates with the deformed state of the biological surface and information on physical activity state (exercise information).
  • biological activity information biological activity information
  • information on physical activity state exercise information
  • examples of the life activity information include a pulse rate (heart rate), a respiration rate, a respiration depth, and the like.
  • the movement information includes, for example, the amount of bending when bending a joint (bending angle), movement of cheeks during pronunciation / speech, movement of facial muscles, movement of scapula, movement of gluteal muscles, movement of back Movement, hip bending, chest movement, thigh and calf contraction due to muscle contraction, throat movement during swallowing, foot movement, hand movement, finger movement, sole movement, blinking Examples include movement, easiness of skin elongation (flexibility), and the like.
  • the biological information measuring apparatus it is possible to simultaneously acquire the biological activity information and exercise information and the above-described biological potential.
  • the relationship between the type of exercise and the capacitance value and how to change it is acquired as calibration information for each living body to be measured. You can keep it. This is because even if there is an individual difference, it can be measured more accurately.
  • These pieces of information are effective as information for diagnosing the health condition of the subject and determining the sport training menu and rehabilitation training menu for the subject.
  • one probe may include a plurality of external electrodes.
  • FIGS. 5A and 5B are diagrams schematically showing another example of the biological information measuring probe according to the second embodiment.
  • FIG. 5A is a rear view
  • FIG. FIG. 6 is a cross-sectional view taken along the line CC of FIG.
  • the probe 30 according to the present embodiment is different from the probe 2 according to the first embodiment in the configuration of external electrodes and electrical terminals.
  • the probe 30 has the capacitance detection sheet 10 sandwiched between two covering members 31 (31A, 31B).
  • the configuration of the covering member 31 is the same as that of the covering member 21 of the first embodiment.
  • reference numeral 32 denotes a lead wire for connecting the capacitance detection sheet 10 to a measuring instrument.
  • two external electrodes 34a and 34b are provided apart from each other on the back side of the covering member 31B.
  • the external electrodes 34a and 34b are provided on both ends in the longitudinal direction on the back side of the covering member 31B.
  • the external electrodes 34a and 34b are provided such that a part or all of the detection portion of the capacitance detection sheet 10 is positioned between the external electrodes 34a and 34b when viewed in plan. Electrical terminals 33a and 33b to which lead wires 35a and 35b are connected are attached between the external electrodes 34a and 34b and the covering member 31B.
  • the material of the external electrodes 34a and 34b is the same as that of the external electrode 24 of the first embodiment. Therefore, when the capacitance detection sheet 10 is deformed, it has flexibility and adhesiveness that can be deformed as necessary.
  • the measurement of the bioelectric potential and the measurement of the deformation state of the living body surface can be performed with one probe 30.
  • the probe 30 for example, in the subject's upper arm, by attaching the probe 30 so that the direction of the muscle fiber of the biceps brachii and the longitudinal direction of the probe 30 are substantially parallel, the same measurement as in the first embodiment is performed, The deformation state of the surface of the living body in the direction of expansion and contraction of the biceps brachii and the myoelectric potential at that time can be measured with one probe 30.
  • the probe according to the embodiment of the present invention may include two or more external electrodes in one probe.
  • the position where each external electrode is provided is not limited to the position shown in FIGS. 5A and 5B, and can be provided at any position as long as they are separated from each other.
  • the capacitance detection sheet provided in the probe is formed on the dielectric layer (first dielectric layer) and the first electrode layer and the second electrode layer formed on both surfaces thereof.
  • a second dielectric layer and a third electrode layer may be provided.
  • FIG. 6A is a perspective view schematically showing a capacitance detection sheet constituting the biological information measuring probe according to the present embodiment
  • FIG. 6B is a cross-sectional view of FIG. It is D line sectional drawing.
  • 6A and 6B includes a sheet-like first dielectric layer 41A made of an elastomer composition and a first dielectric layer 41A formed on the front surface of the first dielectric layer 41A.
  • the capacitance detection sheet 40 includes a first wiring 43A connected to the first electrode layer 42A, a second wiring 43B connected to the second electrode layer 42B, and a first wiring connected to the third electrode layer 42C.
  • a back side protective layer 45B and a front side protective layer 45A are provided on the back side of the first dielectric layer 41A and the front side of the second dielectric layer 41B, respectively.
  • the first electrode layer 42A to the third electrode layer 42C have the same planar view shape.
  • the first electrode layer 42A and the second electrode layer 42B are opposed to each other across the first dielectric layer 41A.
  • the first electrode layer 42A and the third electrode layer 42C are entirely opposed to each other with the second dielectric layer 41B interposed therebetween.
  • a portion where the first electrode layer 42A and the second electrode layer 42B face each other and a portion where the first electrode layer 42A and the third electrode layer 42C face each other serve as a detection unit.
  • the sum of the capacitance of the opposed portion of the first electrode layer 42A and the second electrode layer 42B and the capacitance of the opposed portion of the first electrode layer 42A and the third electrode layer 42C is the detection unit. Capacitance.
  • the probe provided with the capacitance detection sheet 40 is suitable for eliminating a measurement error due to noise and measuring a change in capacitance more accurately. I will explain this in more detail.
  • the biological information measuring device according to the embodiment of the present invention is used and the deformation state of the living body surface is measured based on the capacitance of the detection unit, the living body surface is a conductor and therefore is close to the living body. May cause noise.
  • the probe according to the embodiment of the present invention has an external electrode on the back side of the capacitance detection sheet via an insulating layer (covering member), the external electrode may cause noise. .
  • the biological information measuring device provided with the probe having the capacitance detection sheet 40 measurement errors due to noise can be more reliably eliminated.
  • the biological information measuring device includes a plurality of the probes
  • the configuration of each probe does not need to be the same
  • the biological information measuring device may include probes having different configurations.
  • the biological information measuring apparatus may include a probe having one external electrode and a probe having two or more external electrodes at the same time.
  • the capacitance detection sheet includes an elastomer dielectric layer. These dielectric layers can be formed using an elastomer composition. In the case where the capacitance detection sheet includes the first dielectric layer and the second dielectric layer, both may be formed using the same elastomer composition, or may be formed using different elastomer compositions. May be. Both are preferably formed using the same elastomer composition. This is because the same behavior is exhibited during deformation.
  • the dielectric layer is a sheet-like material formed using an elastomer composition, and can be reversibly deformed so that the areas of the front and back surfaces thereof are changed. Therefore, the dielectric layer can be deformed in the surface direction of the sheet.
  • the front and back surfaces of the dielectric layer mean the front surface and the back surface of the dielectric layer.
  • elastomer composition what contains an elastomer and another arbitrary component as needed is mentioned, for example.
  • the elastomer include natural rubber, isoprene rubber, nitrile rubber (NBR), ethylene propylene rubber (EPDM), styrene / butadiene rubber (SBR), butadiene rubber (BR), chloroprene rubber (CR), silicone rubber, and fluorine.
  • examples thereof include rubber, acrylic rubber, hydrogenated nitrile rubber, and urethane rubber. These may be used alone or in combination of two or more. Among these, urethane rubber and silicone rubber are preferable in that permanent set (or permanent elongation) is small.
  • the elastomer composition may contain additives such as a plasticizer, an antioxidant, an antioxidant, a colorant, a dielectric filler, and the like.
  • the average thickness of the dielectric layer is preferably 10 to 1000 ⁇ m from the viewpoint of increasing the capacitance and improving the detection sensitivity. More preferably, it is 30 to 200 ⁇ m.
  • the dielectric layer is preferably deformable in the surface direction so that the area (the area of the front surface and the surface of the back surface of the dielectric layer) is increased by 30% or more from the unstretched state when deformed. This is because this is suitable for following the deformation of the living body surface.
  • the fact that the area can be deformed so as to increase by 30% or more means that it does not break even when the load is increased and the area is increased by 30%, and it is restored to its original state when the load is released (ie, elastic It is within the deformation range.
  • the deformable range of the area of the dielectric layer is more preferably deformable to increase by 50% or more, more preferably deformable to increase by 100% or more, and increased by 200% or more. It is particularly preferable that it can be deformed.
  • the deformable range of the area of the dielectric layer can be controlled by the design (material, shape, etc.) of the dielectric layer.
  • the capacitance detection sheet includes the electrode layer made of a conductive composition containing a conductive material.
  • each of the electrode layers may be composed of conductive compositions having the same composition, or may be composed of conductive compositions having different compositions.
  • the conductive material examples include carbon nanotubes, graphene, carbon nanohorns, carbon fibers, conductive carbon black, graphite, metal nanowires, metal nanoparticles, and conductive polymers. These may be used alone or in combination of two or more.
  • carbon nanotubes are preferable. This is because it is suitable for forming an electrode layer that deforms following the deformation of the dielectric layer.
  • a known carbon nanotube can be used as the carbon nanotube.
  • the carbon nanotube may be a single-walled carbon nanotube (SWNT), a double-walled carbon nanotube (DWNT), or a multi-walled carbon nanotube (MWNT) having three or more layers (in this specification, Both are simply referred to as multi-walled carbon nanotubes).
  • SWNT single-walled carbon nanotube
  • DWNT double-walled carbon nanotube
  • MWNT multi-walled carbon nanotube having three or more layers
  • two or more types of carbon nanotubes having different numbers of layers may be used in combination.
  • the shape (average length, fiber diameter, aspect ratio) of each carbon nanotube is not particularly limited. The shape of the carbon nanotubes may be appropriately selected by comprehensively judging the conductivity and durability required for the capacitance detection sheet, and further the treatment and cost for forming the electrode layer.
  • the conductive composition may contain a binder component that functions as a binder for the conductive material, various additives, and the like.
  • the additive include a dispersant for a conductive material, a crosslinking agent for a binder component, a vulcanization accelerator, a vulcanization aid, an anti-aging agent, a plasticizer, a softener, and a colorant. Can be mentioned.
  • the protective layer (front side protective layer and back side protective layer) is preferably laminated.
  • the electrode layer and the like can be electrically insulated from the outside.
  • the strength and durability of the capacitance detection sheet can be increased.
  • the material for the protective layer include the same elastomer composition as the material for the dielectric layer.
  • the following covering member may also serve as the protective layer.
  • the biological information measuring probe has an insulating covering member around the capacitance detection sheet. It is preferable to be provided.
  • the covering member include a cloth material having stretchability (regardless of anisotropy and isotropic property) and a member made of an elastomer composition.
  • the cloth fabric is not particularly limited as long as it has stretchability, and may be a woven fabric, a knitted fabric, or a non-woven fabric.
  • the cloth fabric is integrated with the capacitance detection sheet using an adhesive such as an acrylic adhesive, a urethane adhesive, a rubber adhesive, or a silicone adhesive.
  • the pressure-sensitive adhesive needs to have flexibility that does not hinder the expansion and contraction of the dielectric layer.
  • the covering member is not necessarily provided.
  • the said covering member may be provided in both surfaces of the said capacitance detection sheet, and may be provided only in the single side
  • the external electrode is not particularly limited, and an electrode similar to an electrode used in a device for measuring a biopotential such as an electrocardiograph, an electromyograph or an electroencephalograph can be used. However, when the external electrode is provided at a position overlapping the detection portion of the capacitance detection sheet 10 in the thickness direction like the probe 2 of the first embodiment, the external electrode does not hinder the expansion and contraction of the detection portion.
  • a flexible one is used.
  • the flexible external electrode for example, an electrode made of conductive hydrogel can be used. Specific examples of the hydrogel having conductivity include, for example, Sekisui Chemical Co., Ltd., Technogel (trade name), and the like.
  • the said external electrode has what has adhesiveness. This is because the probe can be attached to the surface of a living body without forming an adhesive layer separately.
  • the probe according to the embodiment of the present invention is preferably configured so that the external electrode has adhesiveness as described above and can be attached to the surface of the living body by the adhesive force of the external electrode.
  • the external electrode does not necessarily have adhesiveness.
  • the probe is configured to be attached to the living body with another member such as an adhesive layer provided separately in a state where the external electrode is in close contact with the living body.
  • the probe may include the separate member while the external electrode has adhesiveness.
  • the capacitance detection sheet is usually formed with wirings connected to the electrode layers. Yes.
  • Each wiring may be any wire as long as it does not hinder the deformation of the dielectric layer and can maintain conductivity even when the dielectric layer is deformed.
  • each wiring is made of the same conductive composition as the electrode layer. Can be mentioned.
  • connection part for connecting with is formed.
  • connection part what was formed using copper foil etc. is mentioned, for example.
  • the manufacturing method will be described by taking as an example the case where the probe 2 shown in FIGS. 3A to 3C is manufactured.
  • the capacitance detection sheet 10 is manufactured.
  • the capacitance detection sheet 10 can be manufactured by, for example, a method similar to the sensor sheet manufacturing method described in JP-A-2016-90487.
  • the covering members 21 ⁇ / b> A and 21 ⁇ / b> B are attached to both surfaces of the capacitance detection sheet 10 manufactured through the above-described steps. Thereafter, the electrical terminal 23 to which the external electrode 24 and the lead wire 25 are connected is attached to the back side of the covering member 21B. Through these steps, the biological information measuring probe 2 shown in FIGS. 3A to 3C can be manufactured.
  • the measuring instrument is connected to each of the capacitance detection sheet and the external electrode. As described above, the measuring instrument has a function of measuring the capacitance of the detection unit and a function of measuring a potential difference between the plurality of external electrodes.
  • the measuring instrument includes a capacitance measuring circuit, an arithmetic circuit, an amplifier circuit, a power supply circuit, and the like necessary for that purpose.
  • a method of measuring the capacitance for example, a method of measuring with a measuring instrument such as an LCR meter, a method of measuring using a CV conversion circuit using an automatic balanced bridge circuit, a CV conversion circuit using an inverting amplifier circuit , Measurement method using a CV conversion circuit using a half-wave voltage doubler rectifier circuit, measurement method using a CF oscillation circuit using a Schmitt trigger oscillation circuit, Schmitt trigger oscillation circuit and F / Examples include a method of measuring with a measuring instrument such as a voltage measuring instrument or a frequency counter after the capacitance is converted into a voltage or a frequency by a V conversion circuit or the like.
  • the following connection method is preferable as the connection method between the two.
  • the capacitance detection sheet 10 shown in FIGS. 2A and 2B is connected to the measuring instrument, the back side protective layer 15B side of the capacitance detection sheet 10 is placed on the external electrode side (on the surface of the living body). It is preferable to connect to the measuring instrument with the front side connecting portion 14A as a signal line and the back side connecting portion 14B as a ground line.
  • the first connecting portion 44A is connected to the signal line, the second connecting portion 44B and the third connecting portion 44C are connected. It is preferable to connect to the measuring instrument as an earth line.
  • the back side protective layer 45B side may be the external electrode side (side attached to the surface of the living body), and the front side protective layer 45A side may be the external electrode side.
  • the measuring instrument As a method for measuring the potential difference between the external electrodes, a method similar to the method for measuring the bioelectric potential employed in conventional electrocardiographs, electromyographs, electroencephalographs and the like can be employed.
  • the measuring instrument also includes a circuit necessary for this purpose.
  • ⁇ Display> As the display, a computer having a storage unit such as a CPU, RAM, ROM, and HDD, a monitor, various input / output interfaces, and the like can be used.
  • a terminal device such as a personal computer, a smartphone, or a tablet can be used as the display.
  • the measuring instrument 3 and the display 4 are connected by wire, but both may be connected wirelessly.
  • Example 1 ⁇ Preparation of capacitance detection sheet> The capacitance detection sheet 10 shown in FIGS. 2A and 2B was produced.
  • (1) Preparation of dielectric layer For 100 parts by mass of polyol (Pandex GCB-41, manufactured by DIC), 40 parts by weight of plasticizer (dioctyl sulfonate) and isocyanate (Pandex GCA-11, manufactured by DIC) 17 .62 parts by weight were added and stirred and mixed with an agitator for 90 seconds to prepare a raw material composition for a dielectric layer. Next, it heated in the heating apparatus (crosslinking furnace), conveying a raw material composition in the state pinched
  • the heating apparatus crosslinking furnace
  • cross-linking was performed under the conditions of an in-furnace temperature of 70 ° C. and an in-furnace time of 30 minutes to obtain a roll-wrapped sheet having a predetermined thickness with a protective film. Then, after cross-linking in a furnace adjusted to 70 ° C. for 12 hours, a sheet made of a polyether urethane elastomer was produced. The obtained urethane sheet was cut into a size of 14 mm ⁇ 80 mm ⁇ thickness 100 ⁇ m, and one corner was cut off at a size of 7 mm ⁇ 20 mm ⁇ thickness 100 ⁇ m to produce a dielectric layer.
  • the elongation at break was 505% and the relative dielectric constant was 5.8.
  • the elongation at break was measured according to JIS K 6251.
  • the dielectric constant is measured by measuring the capacitance at a measurement frequency of 1 kHz using an LCR high tester (manufactured by Hioki Electric Co., Ltd., 3522-50) by sandwiching a dielectric layer with an electrode of 20 mm ⁇ . The relative dielectric constant was calculated.
  • Electrode layer material Highly oriented carbon nanotubes manufactured by Taiyo Nippon Sanso Co., Ltd., which are multi-walled carbon nanotubes manufactured by the substrate growth method (4 to 12 layers, fiber diameter 10 to 20 nm, fiber length 150 to 30 ⁇ g of 300 ⁇ m, carbon purity 99.5%) is added to 30 g of isopropyl alcohol (IPA), wet-dispersed using a jet mill (NanoJet Pal JN10-SP003, manufactured by Joko), and diluted 2 times. A carbon nanotube dispersion liquid having a concentration of 0.05% by weight was obtained.
  • IPA isopropyl alcohol
  • an opening having a predetermined shape is formed on one side (front surface) of the back side protective layer 15B produced in the step (3) above on the PET film subjected to the release treatment.
  • a formed mask (not shown) was attached.
  • the mask is provided with openings corresponding to the back side electrode layer and the back side wiring.
  • the size of the opening is 10 mm wide ⁇ 50 mm long corresponding to the back side electrode layer, and the part corresponding to the back side wiring. It is 5 mm wide x 20 mm long.
  • the carbon nanotube dispersion prepared in the step (2) was applied using an air brush so that the coating amount per unit area (cm 2 ) was 0.223 g. At this time, the distance between the application surface and the airbrush injection port was 10 cm. Then, it was made to dry at 100 degreeC for 10 minute (s), and the back side electrode layer 12B and the back side wiring 13B were formed. Thereafter, the mask was peeled off.
  • the dielectric layer 11 produced in the step (1) was laminated on the back side protective layer 15B so as to cover the entire back side electrode layer 12B and a part of the back side wiring 13B. Further, the front electrode layer 12A and the front wiring 13A were formed on the front side of the dielectric layer 11 by using the same method as the formation of the back electrode layer 12B and the back wiring 13B.
  • the front side produced in the above step (3) so that the front side of the dielectric layer 11 on which the front side electrode layer 12A and the front side wiring 13A are formed covers the entire front side electrode layer 12A and a part of the front side wiring 13A.
  • the protective layer 15A was laminated by lamination. Furthermore, the copper foil was attached to each edge part of 13 A of front side wiring, and the back side wiring 13B, and it was set as the front side connection part 14A and the back side connection part 14B. Then, the lead wire 22 used as external wiring was fixed to the front side connection part 14A and the back side connection part 14B with solder, and the capacitance detection sheet 10 was obtained.
  • ⁇ Preparation of adhesive layer 50 parts by weight of methyl ethyl ketone (MEK) and 2 parts by weight of a curing agent (L-45, manufactured by Soken Chemical Co., Ltd.) are added to 50 parts by weight of an adhesive (manufactured by Soken Chemical Co., Ltd., SK Dyne 1720).
  • the mixture was obtained by mixing (2000 rpm, 120 seconds) and defoaming (2000 rpm, 120 seconds) using a model number: ARE-310.
  • the obtained mixture was formed on a PET film (50E-0010KF, manufactured by Fujimori Kogyo Co., Ltd.) having a release treatment on the surface with a wet film thickness of 100 ⁇ m using an applicator. And cured at 100 ° C. for 30 minutes to produce an adhesive layer with a thickness of 30 ⁇ m after curing.
  • a conductive hydrogel (manufactured by Sekisui Plastics Co., Ltd., Technogel HIT-BR3) was prepared as a material for the external electrode.
  • the biological information measuring probe 2 (see FIGS. 3A to 3C) was manufactured by the following method. (1) The adhesive layer produced by the method described above was transferred to one side of the stretchable anisotropic fabric A. Thereafter, the stretchable anisotropic fabric A was cut into a size of horizontal 115 mm ⁇ vertical 30 mm. At this time, it cut
  • a stretchable anisotropic fabric (covering member) 21B cut on the back side of the capacitance detection sheet 10 produced by the method described above was pasted.
  • the end opposite to the side where the wiring (front side wiring 13A and back side wiring 13B) of the capacitance detection sheet 10 is formed at a position 15 mm from one end in the longitudinal direction (horizontal direction) of the stretch anisotropic fabric 21B.
  • the stretch anisotropic fabric 21B was pasted so that the portion was positioned.
  • the stretchable anisotropic fabric (coating member) 21A cut in (1) above is also attached to the front surface side of the capacitance detection sheet, and the capacitance detection sheet is sandwiched between the two cloth fabrics. It is.
  • An electrical terminal (HRT-203G, manufactured by Hirosugi Keiki Co., Ltd.) 23 connected to the lead wire 25 is connected to the back side of the stretch anisotropic fabric 21B, and the wiring of the capacitance detection sheet 10 (the front side wiring 13A or the back side)
  • a double-sided tape No. 777 manufactured by Teraoka Seisakusho Co., Ltd.
  • the external electrode material was cut into a size of 15 mm (vertical) ⁇ 70 mm (horizontal) and pasted on the back side of the stretchable anisotropic fabric 21B. At this time, the external electrode material was attached to a position that overlaps the detection portion of the capacitance detection sheet 10 in the thickness direction and covers the electrical terminal 23.
  • the probe 2 was produced through such steps. Three probes 2 were prepared.
  • the lead wire 25 connected to the external electrode 24 is connected to an electrocardiograph (Fukuda Electronics, FX-7542), and the lead wire 22 connected to the capacitance detection sheet 10 is connected to the PowerLab. Connected to 16/35, PL3516 (manufactured by AD INSTRUMENTS) to obtain a biological information measuring device.
  • the lead wire connected to the front side connection portion 14A was used as a signal line
  • the lead wire connected to the back side connection portion 14B was used as an earth line.
  • FIG. 7 is a diagram for explaining the mounting position of the biological information measuring probe in the first embodiment.
  • three probes 101 to 103 were attached to the subject so as to obtain a lead II electrocardiogram. That is, the probe 101 was attached as a positive electrode on the lowermost rib on the left anterior axillary line, the probe 102 was attached as a negative electrode to the right subclavian fossa, and the probe 103 was attached as a ground electrode to the left subclavian fossa.
  • the subject was allowed to walk at a walking speed of 60 steps / minute, and an electrocardiogram at that time was obtained and the respiratory rate was measured.
  • the measurement conditions of PowerLab 16/35 and PL3516 were a sampling frequency of 100 Hz, a measurement range ⁇ 5 V, and display software LabChart 8.0.9.
  • 104 is an electrocardiograph
  • 105 is PowerLab 16/35, PL3516.
  • FIG. 8 the measurement waveform by the probe 101 is shown in the upper stage, the waveform obtained by processing the measurement waveform by the probe 101 with a 0.6 Hz low-pass filter is shown in the middle stage, and the electrocardiogram of the second lead is shown in the lower stage.
  • the use of the biological information measuring device can simultaneously obtain an electrocardiogram and measure the respiration rate even when the subject is in a walking state.
  • the respiration rate was confirmed in the measurement waveforms obtained by the probes 102 and 103.
  • the measurement waveforms by the probes 101 to 103 reflect the respiration rate.
  • the measurement by the probes 101 to 103 and the measurement of respiration using a flow sensor (performed by the subject wearing a mask). Confirmed at the same time.
  • Example 2 ⁇ Production of biological information measurement probe> A probe 2 was produced in the same manner as in Example 1. Here, two probes 2 were produced.
  • the lead wire 25 connected to the external electrode 24 is connected to a biological measuring instrument (BA1078 manufactured by Miyuki Giken Co., Ltd.), and the lead wire 22 connected to the capacitance detection sheet 10 is connected to the PowerLab 16 / 35, PL3516 (manufactured by AD INSTRUMENTS) was used as a biological information measuring device.
  • the lead wire connected to the front side connection portion 14A was used as a signal line
  • the lead wire connected to the back side connection portion 14B was used as an earth line.
  • the measurement conditions of PowerLab 16/35 and PL3516 were a sampling frequency of 100 Hz, a measurement range ⁇ 5 V, and display software LabChart 8.0.9.
  • the measurement conditions of the bioinstrument BA1078 were Sens: 500 ⁇ V / 0.5 V, Tc: 0.03 sec, and Hff: 3000 Hz.
  • FIG. 9 the measurement waveform by the probe 2A is shown in the upper stage, and the change in myoelectric potential by the probes 2A and 2B is shown in the lower stage.
  • Ts shows the bending start time of an elbow joint
  • Tf shows the bending end time of an elbow joint
  • the biological information measuring probe of the present invention includes a capacitance detection sheet including a dielectric layer whose areas of the front and back surfaces reversibly change as a capacitance detection sheet.
  • a capacitance detection sheet including a dielectric layer whose areas of the front and back surfaces reversibly change as a capacitance detection sheet.
  • a sheet-shaped first dielectric layer made of an elastomer composition and a conductive composition containing a conductive material
  • a first electrode layer and a second electrode layer formed on the front surface and the back surface of the first electrode layer and the second electrode layer, respectively, so as to face at least a part of the first dielectric layer.
  • the opposing part is used as the detecting unit.
  • the capacitance detection sheet two types of biological information such as the bioelectric potential and the deformation state of the living body surface can be acquired simultaneously.

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  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne une sonde destinée à être utilisée dans la mesure d'informations biologiques, comprenant : une feuille de détection de capacité électrostatique qui comprend une première couche diélectrique de type feuille constituée d'une composition élastomère et des première et seconde couches d'électrode et qui peuvent être déformées de manière réversible de telle sorte que les zones des surfaces avant et arrière de la couche diélectrique peuvent varier, chacune des première et seconde couches d'électrode étant constituée d'une composition électriquement conductrice contenant un matériau électroconducteur et les première et seconde couches d'électrode étant respectivement formées sur la surface avant et la surface arrière de la première couche diélectrique de telle sorte que les première et seconde couches d'électrode peuvent se faire face au moins partiellement avec la première couche diélectrique intercalée entre elles, et une partie au niveau de laquelle les première et seconde couches d'électrode se font face sert de partie détection ; et une électrode externe qui est disposée sur le côté arrière de la feuille de détection de capacité électrostatique avec une couche d'isolation intercalée entre celles-ci et peut entrer en contact avec la surface d'un corps vivant.
PCT/JP2017/032038 2016-09-07 2017-09-06 Sonde destinée à être utilisée dans la mesure d'informations biologiques, et dispositif de mesure d'informations biologiques WO2018047842A1 (fr)

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JP7298881B2 (ja) 2018-06-06 2023-06-27 国立大学法人電気通信大学 筋電センサ及び電極部材
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