WO2021187247A1 - 携帯型心電装置、心電計測システム、およびプログラム - Google Patents

携帯型心電装置、心電計測システム、およびプログラム Download PDF

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Publication number
WO2021187247A1
WO2021187247A1 PCT/JP2021/009346 JP2021009346W WO2021187247A1 WO 2021187247 A1 WO2021187247 A1 WO 2021187247A1 JP 2021009346 W JP2021009346 W JP 2021009346W WO 2021187247 A1 WO2021187247 A1 WO 2021187247A1
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WIPO (PCT)
Prior art keywords
electrocardiographic
lead
induction
measurement
waveform
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Ceased
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PCT/JP2021/009346
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English (en)
French (fr)
Japanese (ja)
Inventor
充 鮫島
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Omron Healthcare Co Ltd
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Omron Healthcare Co Ltd
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Publication date
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Priority to CN202180017823.3A priority Critical patent/CN115209807A/zh
Priority to DE112021000556.1T priority patent/DE112021000556T5/de
Publication of WO2021187247A1 publication Critical patent/WO2021187247A1/ja
Priority to US17/932,159 priority patent/US20230011154A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/282—Holders for multiple electrodes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/024—Measuring pulse rate or heart rate
    • A61B5/02438—Measuring pulse rate or heart rate with portable devices, e.g. worn by the patient
    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/332—Portable devices specially adapted therefor
    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/339—Displays specially adapted therefor
    • 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
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/346—Analysis of electrocardiograms
    • A61B5/349—Detecting specific parameters of the electrocardiograph cycle
    • A61B5/352—Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7271—Specific aspects of physiological measurement analysis
    • A61B5/7282—Event detection, e.g. detecting unique waveforms indicative of a medical condition
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/742—Details of notification to user or communication with user or patient; User input means using visual displays
    • A61B5/743—Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/74—Details of notification to user or communication with user or patient; User input means
    • A61B5/746—Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A61B5/0006—ECG or EEG signals
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the present invention relates to a portable electrocardiographic device capable of measuring an electrocardiographic waveform in daily life and an electrocardiographic measurement system including the portable electrocardiographic device.
  • a portable electrocardiographic measuring device (hereinafter, also referred to as “portable electrocardiographic device”) that can immediately measure an electrocardiographic waveform when an abnormality such as chest pain or palpitation occurs in daily life has been proposed. Doctors, etc., perform early detection of heart disease and appropriate treatment based on the electrocardiographic waveform data measured by the electrocardiographic device when symptoms such as palpitation occur at home or on the go. Will be possible.
  • the induction method called I lead in which the contact portion including the positive electrode is pressed against the left hand of the subject
  • the induction method called V4 lead in which the contact portion including the positive electrode is pressed against the left chest of the subject.
  • a technique for displaying measurement results such as an electrocardiographic waveform on a display unit in an easy-to-see manner is known (see, for example, Patent Document 1).
  • the measurement result is displayed in the horizontal direction on the display unit when the measurement is performed by the I lead, and the measurement result is displayed in the vertical direction on the display unit when the measurement is performed by the V4 lead.
  • the present invention makes it possible to measure the electrocardiographic waveform by using the optimum induction method according to the state of the electrocardiographic waveform, and improve the accuracy of the electrocardiographic measurement.
  • the purpose is to provide the technology to make it.
  • the present invention for solving the above problems is a portable electrocardiographic device capable of measuring an electrocardiographic waveform using a plurality of types of induction methods.
  • An electrode part that measures the electrocardiographic waveform by contacting it with a predetermined part of the subject's body
  • An analysis unit that analyzes the electrocardiographic waveform measured by the electrode unit according to the induction method at the time of measuring the electrocardiographic waveform
  • an analysis unit that analyzes the electrocardiographic waveform measured by the electrode unit according to the induction method at the time of measuring the electrocardiographic waveform
  • a storage unit in which the electrocardiographic waveform measured at the electrode unit, the induction method, and the analysis result obtained by analyzing the electrocardiographic waveform by the analysis unit are stored in association with each other.
  • the remeasurement promotion prompts the user to remeasure by a predetermined induction method different from the induction method at the time of measuring the electrocardiographic waveform.
  • Department and It is a portable electrocardiographic device equipped with.
  • the remeasurement promotion unit prompts the remeasurement after changing the induction method to the optimum one. It was to be. According to this, even if the induction method used at the time of our measurement is not optimal, it is possible to perform remeasurement after optimizing the induction method. As a result, it is possible to improve the accuracy of the analysis result.
  • the user means a person who operates a portable electrocardiographic device.
  • the remeasurement promotion unit may have a display means for displaying the guidance method to be set at the time of the remeasurement.
  • a light emitting unit associated with a plurality of types of induction methods may be provided in the main body of the apparatus, and the light emitting unit associated with the induction method to be set at the time of remeasurement may be made to emit light. ..
  • the guidance method to be set at the time of remeasurement may be displayed directly on the display means capable of displaying characters. According to this, the user can more easily recognize the guidance method to be set at the time of remeasurement.
  • the display means may further display that the predetermined conditions are satisfied. This allows the user to more easily recognize why the guidance method to be set at the time of remeasurement was selected.
  • the present invention further includes a setting unit for setting which of the plurality of induction methods is used to measure the electrocardiographic waveform.
  • the user may set the guidance method by the setting unit. According to this, the user can select the guidance method to be used at the time of measurement or remeasurement at his / her own will.
  • the induction method at the time of the measurement is the I lead in the 12-lead method.
  • the predetermined condition is when an arrhythmia is found in the analysis result.
  • the predetermined induction method may be V4 induction in the 12-induction method.
  • the electrocardiographic waveform is measured by using the I lead at the time of measurement, and when an arrhythmia is found in the analysis result, the remeasurement promotion unit promotes the remeasurement by using the V4 lead. bottom. According to this, it becomes possible to diagnose arrhythmia more accurately.
  • the induction method at the time of the measurement is the I lead in the 12-lead method.
  • the predetermined condition is when atrial fibrillation is observed in the analysis result.
  • the predetermined induction method may be V1 induction in the 12-induction method.
  • the electrocardiographic waveform is measured by using the I lead at the time of measurement, and when atrial fibrillation is observed in the analysis result, the remeasurement promotion unit promotes the remeasurement by using the V1 lead. I decided. According to this, it becomes possible to diagnose atrial fibrillation more accurately.
  • the induction method at the time of the measurement is the I lead in the 12-lead method.
  • the predetermined condition is a case where poor waveform quality is found in the analysis result.
  • the predetermined induction method may be V1 induction or V4 induction in the 12-induction method.
  • the electrocardiographic waveform is measured using the I lead at the time of measurement, and when a poor waveform quality is found in the analysis result, the remeasurement promotion unit remeasures using the V1 lead or the V4 lead. It was decided to promote the measurement. According to this, it becomes possible to detect the defect of the waveform quality of the electrocardiographic waveform more accurately.
  • the present invention is provided so as to be able to communicate with a portable electrocardiographic device provided with an electrode portion for detecting an electrocardiographic waveform in contact with a predetermined portion of the body of a subject and the portable electrocardiographic device.
  • It is an electrocardiographic measurement system that is equipped with a mobile communication terminal and can measure electrocardiographic waveforms using multiple types of induction methods.
  • An analysis unit that analyzes the electrocardiographic waveform measured by the electrode unit according to the induction method at the time of measuring the electrocardiographic waveform, and an analysis unit.
  • a storage unit in which the electrocardiographic waveform measured at the electrode unit, the induction method, and the analysis result obtained by analyzing the electrocardiographic waveform by the analysis unit are stored in association with each other.
  • the remeasurement promotion prompts the user to remeasure by a predetermined induction method different from the induction method at the time of measuring the electrocardiographic waveform.
  • Department and It may be an electrocardiographic measurement system further provided with.
  • the user means a person who operates an electrocardiographic measurement system.
  • the remeasurement promoting unit is Provided in either the portable electrocardiographic device or the portable communication terminal.
  • the electrocardiographic measurement system may be characterized in that it has a display means for displaying the guidance method to be set at the time of the remeasurement. According to this, the user can recognize the induction method to be used at the time of remeasurement by using the display means. Further, when the display means is provided in the mobile communication terminal, it is possible to display the guidance method to be used at the time of remeasurement by using the high-performance display of the mobile terminal.
  • the present invention may be the above-mentioned electrocardiographic measurement system, wherein the display means further displays that the predetermined condition is satisfied. According to this, the user can recognize a predetermined condition by using the display means. Further, when the display means is provided in the mobile communication terminal, it is possible to display a predetermined condition by using the high-performance display of the mobile terminal.
  • the present invention further includes a setting unit for setting which of the plurality of induction methods is used to measure the electrocardiographic waveform.
  • the electrocardiographic measurement system may be characterized in that the user sets the guidance method by the setting unit at the time of the measurement and the remeasurement. Then, it becomes possible to set the induction method to be used at the time of measurement and at the time of remeasurement. Further, when the setting unit is provided in the mobile communication terminal, it is possible to remotely set the guidance method to be used at the time of measurement and remeasurement by using the mobile terminal.
  • the induction method at the time of the measurement is I-lead in the 12-lead method.
  • the predetermined condition is when an arrhythmia is found in the analysis result.
  • the predetermined induction method may be the above-mentioned electrocardiographic measurement system, characterized in that it is V4 induction in the 12-lead method.
  • the induction method at the time of the measurement is I-lead in the 12-lead method.
  • the predetermined condition is when atrial fibrillation is observed in the analysis result.
  • the predetermined induction method may be the above-mentioned electrocardiographic measurement system, which is the V1 induction in the 12-lead method.
  • the induction method at the time of the measurement is I-lead in the 12-lead method.
  • the predetermined condition is a case where poor waveform quality is found in the analysis result.
  • the predetermined induction method may be the above-mentioned electrocardiographic measurement system characterized by being V1 lead or V4 lead in the 12-lead method.
  • the display means in the electrocardiographic measurement system is provided in the mobile communication terminal, the present invention is described so that the display means displays the guidance method to be set at the time of the remeasurement. It may be a program that controls a mobile communication terminal.
  • the present invention presents the mobile communication so that the display means displays that the predetermined condition is satisfied. It may be a program that controls the terminal.
  • the present invention sets the guidance method by the setting unit at the time of the measurement and the remeasurement. It may be a program that controls the mobile communication terminal so as to be possible.
  • the means for solving the above problems can be used in combination as much as possible.
  • the present invention when measuring an electrocardiographic waveform, it is possible to measure using an optimum induction method according to the state of the electrocardiographic waveform, and it is possible to improve the accuracy of the electrocardiographic measurement. ..
  • FIG. 1 (A) to 1 (F) are views showing the appearance of the portable electrocardiographic device according to the present embodiment.
  • FIG. 2 is a functional block diagram of the portable electrocardiographic device of the present embodiment.
  • FIG. 3 is a functional block diagram of the smartphone of the present embodiment.
  • FIG. 4 is a flowchart showing a procedure of a basic electrocardiographic measurement process of the portable electrocardiographic device of the present embodiment.
  • FIG. 5 is a diagram illustrating a parameter to be identified as an electrocardiographic waveform.
  • 6 (A) to 6 (L) are diagrams illustrating electrocardiographic waveforms for each induction type.
  • FIG. 7 is a flowchart showing a procedure of an electrocardiographic measurement process for adding a different induction method in the disassembled electrocardiographic device of the present embodiment.
  • FIG. 1 (A) to 1 (F) are views showing the appearance of the portable electrocardiographic device according to the present embodiment.
  • FIG. 2 is a functional block diagram of the portable electrocardiographic device of
  • FIG. 8 is a part of a flowchart showing a procedure of a basic electrocardiographic measurement process in which the portable electrocardiographic device of the present embodiment and a smartphone cooperate with each other.
  • FIG. 9 is a part of a flowchart showing a procedure of a basic electrocardiographic measurement process in which the portable electrocardiographic device of the present embodiment and a smartphone cooperate with each other.
  • 10 (A) and 10 (B) are views showing a display example of the smartphone of the present embodiment.
  • FIG. 11 is a part of a flowchart showing a procedure of an electrocardiographic measurement process in which a portable electrocardiographic device of the present embodiment and a smartphone cooperate with each other to add different guidance methods.
  • FIG. 12 is a part of a flowchart showing a procedure of an electrocardiographic measurement process in which a portable electrocardiographic device of the present embodiment and a smartphone cooperate with each other to add different guidance methods.
  • 13 (A) and 13 (B) are diagrams showing other display examples of the smartphone of the present embodiment.
  • FIG. 1A is a front view of the portable electrocardiographic device 100.
  • FIG. 1B is a view of the portable electrocardiographic device 100 as viewed from below.
  • FIG. 1C is a view of the portable electrocardiographic device 100 as viewed from above.
  • FIG. 1D is a diagram showing a left side surface of the portable electrocardiographic device 100 as viewed from the front surface.
  • FIG. 1 (E) is a view showing a right side surface of the portable electrocardiographic device 100 as viewed from the front surface.
  • FIG. 1F is a rear view of the portable electrocardiographic device 100.
  • the vertical direction means the vertical direction on the paper surface with respect to the portable electrocardiographic device 100 in the posture shown in FIG. 1 (A).
  • the main body 1 of the portable electrocardiographic device 100 has a substantially quadrangular prism shape with rounded corners, and the front and back surfaces are formed flat.
  • a first electrode 2 is provided on the bottom of the portable electrocardiographic device 100.
  • the upper part of the portable electrocardiographic device 100 is provided with a second electrode 3 on the left side and a third electrode 4 on the right side when viewed from the front surface.
  • the upper part of the portable electrocardiographic device 100 has a shape that is smoothly curved so that the index finger of the subject's right hand can easily come into contact with the device.
  • a measurement notification LED 5 and an abnormal wave detection LED 6 are arranged side by side on the front surface of the main body 1 of the portable electrocardiographic device 100.
  • the measurement notification LED 5 is a light emitting element that lights up or blinks when measuring an electrocardiographic waveform.
  • the abnormal waveform detection LED 6 is a light emitting element that lights up when an abnormal waveform is detected with respect to the measured electrocardiographic waveform. Through the lighting of the abnormal waveform detection LED 6, the subject is notified of the presence or absence of the abnormal waveform detected from the measurement data of the electrocardiographic waveform.
  • a power switch 7, a power LED 8, a BLE communication button 9, a communication LED 10, a memory remaining display LED 11, and a battery replacement LED 12 are arranged side by side on the left side of the main body 1 of the portable electrocardiographic device 100 when viewed from the front. ing.
  • the power switch 7 is a push switch for turning on the power of the portable electrocardiographic device 100
  • the power LED 8 is a light emitting element that lights up when the power is turned on.
  • the BLE communication button 9 is an operation component for functioning communication with a device compliant with the BLE (Bluetooth (registered trademark) Low Energy) method
  • the communication LED 10 is a light emitting element that lights up during communication.
  • the communication function of the portable electrocardiographic device 100 is not limited to the BLE method, but is a wireless communication method such as infrared communication or information transmission by ultrasonic waves, or a wired communication method connected via a cable or a connector. May be good.
  • the memory remaining display LED 11 is a light emitting element that indicates the state of the free capacity of the memory unit, which will be described later.
  • the battery replacement LED 12 is a light emitting element that lights up when the power of the power source (battery) included in the portable electrocardiographic device 100 falls below a predetermined value to encourage battery replacement.
  • a guidance type setting input unit 13 and a guidance type display LED 14 are arranged on the right side surface of the main body 1 of the portable electrocardiographic device 100 when viewed from the front surface.
  • the induction type display LED 14 indicates which of the plurality of induction methods is used to detect the electrocardiographic waveform.
  • the guidance type display LED 14 is an I-lead display LED 14a, a II-lead display LED 14b, a III-lead display LED 14c, a V1-lead display LED 14d, a V2-lead display LED 14e, a V3-lead display LED 14f, a V4 lead display LED 14g, and a V5 lead.
  • the guidance type setting input unit 13 is a button for switching the guidance type when pressed. For example, when the power of the portable electrocardiographic device 100 is turned on, the I guide is set as the initial setting and the I guide display LED 14a is lit, but the button of the guide type setting input unit 13 is selected and pressed. As a result, the II lead is set, and the II lead indicator LED 14b lights up.
  • the guidance types set as lead III, lead V1, lead V2, lead V3, lead V4, lead V5, and lead V6 are sequentially switched, and the corresponding leads are switched.
  • the type display LEDs 14c to 14i are turned on in sequence. Then, the guidance type display LED 14 and the guidance type setting input unit 13 correspond to the setting unit of the present invention.
  • the guidance type display LED is not limited to the case where the LED is provided for each guidance type as described above, and one LED that emits light in a different color for each guidance type is provided so that the guidance type can be distinguished by the emission color of the LED. May be good.
  • a removable battery cover 13 is provided on the back surface of the main body 1 of the portable electrocardiographic device 100.
  • the first electrode 2 provided on the bottom of the main body 1 is in contact with the left palm while holding the portable electrocardiographic device 100 with the right hand.
  • the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4.
  • the subject measures the electrocardiogram while pressing the first electrode 2 provided at the bottom in the direction of pressing the first electrode 2 provided at the bottom from the upper side of the main body provided with the second electrode 3 and the third electrode 4.
  • the tip and middle phalanx of the index finger of the right hand and the left palm correspond to a predetermined portion of the body of the subject of the present invention.
  • the first electrode 2 provided on the bottom of the main body 1 is held on the left thigh (or left ankle) while holding the portable electrocardiographic device 100 with the right hand.
  • the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4.
  • the tip and middle segment of the index finger of the right hand and the left thigh (or left ankle) correspond to predetermined parts of the body of the subject of the present invention.
  • the first electrode 2 provided on the bottom of the main body is held by the left thigh (or left ankle) while holding the portable electrocardiographic device 100 with the left hand.
  • the tip of the index finger of the left hand is brought into contact with the third electrode 4, and the middle phalanx of the index finger of the left hand is brought into contact with the second electrode 3.
  • the subject presses the first electrode 2 provided at the bottom in the direction of the left thigh (or left ankle) from the upper side of the main body provided with the second electrode 3 and the third electrode 4. Perform electrocardiographic measurement while pressing.
  • the tip and middle phalanx of the index finger of the left hand and the left thigh (or left ankle) correspond to predetermined parts of the body of the subject of the present invention.
  • the subject holds the portable electrocardiographic device 100 with his right hand and holds the first electrode 2 provided on the bottom of the main body 1 on the left. Contact the skin slightly to the left of the epigastric region of the chest and below the nipple.
  • the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4.
  • the electrocardiographic measurement is performed while pressing the first electrode 2 provided at the bottom in the direction of pressing the first electrode 2 provided at the bottom from the upper side of the main body 1 provided with the second electrode 3 and the third electrode 4. .
  • the tip and middle segment of the index finger of the right hand and the skin slightly to the left and below the nipple of the epigastric region of the left chest correspond to a predetermined portion of the body of the subject of the present invention.
  • FIG. 2 is a functional block diagram showing an example of the configuration of the portable electrocardiographic device 100 according to the present embodiment.
  • the portable electrocardiographic device 100 includes an electrode unit 101, an amplifier unit 102, an AD (Analog to Digital) conversion unit 103, a control unit 104, and a timer unit 105. .. Further, the configuration of the portable electrocardiographic device 100 includes a memory unit 106, a display unit 107, an operation unit 108, a power supply unit 109, and a communication unit 110. The control unit 104, the timer unit 105, the memory unit 106, the display unit 107, the operation unit 108, the power supply unit 109, and the communication unit 110 are connected to each other.
  • the electrode unit 101 includes a first electrode 2 and a third electrode 4 that function as a pair of measurement electrodes, and a second electrode 3 that functions as a GND electrode.
  • An electrocardiographic waveform within a predetermined period is detected through the electrode portion 101 in contact with the skin of the subject.
  • the electrocardiographic waveform detected at each electrode of the electrode unit 101 is input to the amplifier unit 102 connected to the electrode unit, respectively.
  • the signal detected by the electrode unit 101 is amplified and output to the AD conversion unit 103.
  • the detection signal of the electrocardiographic waveform amplified through the amplifier unit 102 is digitally converted and output to the control unit 104.
  • the control unit 104 is a processor such as a CPU that controls the portable electrocardiographic device 100, and by executing a program stored in the memory unit 106, the induction type can be set and the electrocardiographic waveform according to the induction method can be obtained. Various processes such as measurement and analysis are executed.
  • the control unit 104 that executes the analysis process of the electrocardiographic waveform according to the induction method corresponds to the analysis unit of the present invention.
  • the timer unit 105 is a means for receiving an instruction from the control unit 104 and counting various times or periods related to the measurement of the electrocardiographic waveform.
  • the memory unit 106 includes a main storage device such as a ROM (Read Only Memory) and a RAM (Random Access Memory), as well as a long-term storage medium such as a flash memory.
  • the memory unit 106 stores various programs related to measurement and analysis of electrocardiographic waveforms, various information for detecting abnormal waveforms, and the like.
  • the memory unit 106 corresponds to the storage unit of the present invention.
  • the display unit 107 is a means for displaying various information related to the measurement of the electrocardiographic waveform.
  • the display unit 107 includes a measurement notification LED 5, an abnormal waveform detection LED 6 power supply LED 8, a communication LED 10, a memory remaining display LED 11, a battery replacement LED 12, and a guidance type display LED 14.
  • the display unit 107 may include means for displaying various types of information by means of an image / video such as a liquid crystal display.
  • the operation unit 108 is a means for receiving an operation input from the subject or the user.
  • the operation unit 108 includes a power switch 7, a BLE communication button 9, and a guidance type setting input unit 13.
  • the power supply unit 109 is a means for supplying electric power for operating the portable electrocardiographic device 100, and includes a battery, a secondary battery, and the like.
  • the communication unit 110 is a communication interface that controls transmission and reception of signals with a device such as a smartphone 200. BLE communication can be exemplified as the communication function provided by the communication unit 110, but other known wireless communication methods and wired communication methods can be adopted.
  • FIG. 3 is a block diagram showing the configuration of the smartphone 200.
  • the smartphone 200 constitutes an electrocardiographic measurement system in cooperation with the portable electrocardiographic device 100.
  • the smartphone 200 includes a control unit 201, a touch panel display 202, an audio output unit 203 such as a speaker, a memory unit 204, an audio input unit 205 such as a microphone, an operation unit 206 such as a button, a power supply unit 207, and a portable electrocardiographic device 100.
  • a communication unit 208 which is a communication interface that controls transmission / reception of signals by a method such as BLE communication, is provided.
  • the control unit 201 executes various processes such as setting the induction type, displaying the electrocardiographic waveform and the analysis result, and saving.
  • the smartphone 200 which is an example of the portable communication terminal provided so as to be able to communicate with the portable electrocardiographic device 100, a known configuration can be adopted, and thus the details will not be described.
  • the memory unit 204 of the smartphone 200 corresponds to the storage unit of the present invention.
  • FIG. 4 is a flowchart showing a basic procedure of the electrocardiographic waveform measurement process in the electrocardiographic waveform measurement process using the portable electrocardiographic device 100.
  • the power is turned on by pressing the power switch 7 of the portable electrocardiographic device 100 (step S1).
  • the power LED 8 lights up to indicate that the power is on.
  • the subject or the user inputs the guidance type to be measured by the guidance type setting input unit 13 (step S2). For example, if the subject measures the electrocardiographic waveform by V4 lead, pressing the button of the lead type setting input unit 13 six times from the state where the I lead display LED 14a is lit by default sets the lead. The type is sequentially switched to II and III, and the V4 lead display LED 14g lights up to indicate that the electrocardiographic measurement by V4 lead is set (step S2-1).
  • the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4.
  • the first electrode 2 is brought into contact with the skin slightly to the left of the epigastric region of the left chest and below the nipple.
  • the electric signal acquired via the electrodes 2, 3 and 4 is amplified by the amplifier unit 102 and digitally converted by the AD conversion unit 103 to generate a contact state detection signal.
  • the contact state detection signal generated in this way is transmitted to the control unit 104 to detect the contact state between the subject and each of the electrodes 2, 3 and 4 (step S3).
  • the control unit 104 determines whether or not a predetermined time has elapsed while the electrode contact state is maintained (step S4). If No is determined in step S4, step S4 is repeated. If it is determined to be Yes in step S4, the control unit 104 determines the guidance type (step S5).
  • step S2 When V4 lead is set in step S2, the control unit 104 determines in step S5 that the lead type is V4 lead, proceeds to step S17, and starts measuring the electrocardiographic waveform by V4 lead. do.
  • the control unit 104 counts the time from the start of measurement by the timer unit 105, and determines whether or not the predetermined measurement time has elapsed (step S18). If No in step S18, the process returns to step S17 and the measurement of the electrocardiographic waveform is continued. In the case of Yes in step S18, the control unit 104 analyzes the electrocardiographic waveform by V4 induction (step S19). When the analysis of the electrocardiographic waveform is completed, the measurement notification LED 5 is turned on to notify the subject of the completion of the measurement. Since the characteristics of the parameters that specify the electrocardiographic waveform differ depending on the induction method, it is desirable to set an induction method that can obtain electrocardiographic waveform data suitable for the information to be acquired. Further, by performing the electrocardiographic waveform analysis according to the induction method in the analysis of the electrocardiographic waveform data, the optimum electrocardiographic waveform analysis becomes possible.
  • FIG. 5 shows typical electrocardiographic waveform parameters.
  • About P wave, P wave height and P wave width, about Q wave, about Q wave height, about P wave and Q wave, about PQ time, about R wave, about R wave height, about S wave, about S wave height, Q wave, R wave And S wave, QRS width, T wave, T wave height and T wave width, Q wave and T wave, QT time, U wave, U wave height and U wave width are defined, respectively.
  • One or more numerical values of each part of these electrocardiograms or a value calculated based on one or more numerical values can be used as a parameter for specifying the waveform of the electrocardiogram.
  • FIG. 6 shows an electrocardiographic waveform of a typical induction type.
  • 6 (A) is lead I
  • FIG. 6 (B) is lead II
  • FIG. 6 (C) is lead III
  • FIG. 6 (D) is lead V1
  • FIG. 6 (E) is lead V2
  • FIG. 6 (F) Is V3 lead
  • FIG. 6 (G) is V4 lead
  • FIG. 6 (H) is V5 lead
  • FIG. 6 (I) is V6 lead
  • FIG. 6 (J) is aVR lead
  • FIG. 6 (K) is aVL lead.
  • FIG. 6 (L) is an electrocardiographic waveform measured by aVF induction.
  • the electrocardiographic waveform by lead I is an irregular pulse wave at intervals of the R waveform having a high peak value.
  • the ECG waveform by lead I has a small peak value, and the P wave and F wave (similar to the irregular baseline) are easily buried in noise. Therefore, in order to measure the typical electrocardiographic waveform parameters shown in FIG. 5, the optimum electrocardiographic measurement can be performed by collecting the electrocardiographic waveform data by the induction method having a large PQRST shape such as V4 lead. It becomes.
  • the ST ascending / descending determination is also performed. , ST elevating and lowering may not be determined, but other determinations may be made, but the present invention is not limited to this.
  • the control unit 104 associates the electrocardiographic waveform induced by V4 with the analysis result and saves it in a predetermined area of the memory unit 106 (step S20). Then, the control unit 104 displays the result of analyzing the electrocardiographic waveform (step S21). Specifically, when an abnormal waveform is detected as a result of analyzing the electrocardiographic waveform, the abnormal waveform detection LED 6 is turned on to notify the subject that the abnormal waveform has been detected. When the analysis result of the electrocardiographic waveform is displayed and the electrocardiographic measurement process is completed, the power is turned off by the subject or the user pressing the power switch 7 again. From the analysis result display of the electrocardiographic waveform, the power may be turned off when a predetermined time elapses without operating the power switch 7.
  • step S6 the electrocardiographic waveform by the I lead is measured (step S6), the elapse of a predetermined measurement time is waited (step S7), the electrocardiographic waveform analysis of the I lead is performed (step S8), and the electrocardiographic waveform by the I lead is performed. And the analysis result is saved in a predetermined area of the memory unit 106 (step S9).
  • step S10 the abnormality detection LED 6 is turned on to display the analysis result (step S10), the electrocardiographic measurement process is completed, and the power is turned off by pressing the power switch 7. (Step S41).
  • step S2 in addition to the I lead and the V4 lead, the process when the V1 lead is set (steps S12 to S16) and the process when the V6 lead is set (steps S22 to S26).
  • steps S12 to S16 in addition to the I lead and the V4 lead, the process when the V1 lead is set (steps S12 to S16) and the process when the V6 lead is set (steps S22 to S26).
  • the description will be omitted.
  • other induction types that is, V2 lead, V3 lead, and V5 lead, which are omitted from the description, are the same as the processes described for the I lead and the V4 lead, and thus the description thereof will be omitted.
  • Steps S1 to S10 are the same as the electrocardiographic waveform measurement process shown in FIG.
  • I lead is set as the lead type in step S2.
  • Electrocardiographic waveform measurement by lead I is performed in steps S6 and S7, and the electrocardiographic waveform is analyzed in step S8. Then, in step S9, the electrocardiographic waveform by lead I and the analysis result are stored in a predetermined area of the memory unit 106. If there is an abnormality in the electrocardiographic waveform due to lead I in step S8, the abnormal wave detection LED 6 is turned on in step S10. If there is no abnormality in the electrocardiographic waveform due to lead I in step S8, the measurement analysis result is displayed in step S10. The fact that there is no abnormality in the analysis result is indicated by not lighting the abnormal wave detection LED 6 or lighting or blinking the abnormal wave detection LED 6 in a mode different from the case where there is an abnormality in the analysis result.
  • the abnormal wave detection LED 6 corresponds to the display means of the present invention.
  • the control unit 104 determines whether or not there is an abnormality in the electrocardiographic waveform due to the I lead as a result of the electrocardiographic waveform analysis.
  • whether or not there is an abnormality in the electrocardiographic waveform is determined by whether or not the analysis result of the electrocardiographic waveform satisfies a predetermined condition.
  • the predetermined conditions are, for example, conditions such as arrhythmia, atrial fibrillation, and poor waveform quality. When such a condition is satisfied, the control unit 104 determines that the electrocardiographic waveform is abnormal. If No is determined in step S31, the electrocardiographic measurement process is terminated, and the power is turned off by pressing the power switch 7 (step S41). If it is determined to be Yes in step S31, the process proceeds to step S32.
  • lead I it is possible to roughly determine whether or not it is an irregular pulse wave by the interval of the R waveform with a high peak value (see FIG. 6 (A)).
  • the magnitude of the PQRST wave which is a typical parameter of the electrocardiographic waveform shown in FIG. 5, is small, and optimum analysis is difficult. Therefore, if the electrocardiographic waveform measurement is completed as it is, the simple electrocardiographic waveform measurement by the I lead will be completed, and more accurate electrocardiographic waveform measurement and analysis cannot be performed. Therefore, if an abnormal electrocardiographic waveform such as an arrhythmia is detected in the electrocardiographic waveform measurement by lead I, or if the waveform quality is poor, the electrocardiographic waveform measurement by another lead method is promoted.
  • control unit 104 blinks the guidance type display LED 14 corresponding to the guidance method to be additionally implemented (step S32). In this way, the control unit 104 that determines whether or not there is an abnormality in the electrocardiographic waveform, and if it determines that there is an abnormality, performs a process of blinking the induction type LED 14 that prompts remeasurement, remeasures the present invention. Corresponds to the promotion department.
  • the corresponding display LED 14g is blinked by adding the remeasurement of the electrocardiographic waveform by V4 lead.
  • the processing of steps S33 to S35 after the remeasurement by V4 induction is set is the same as that of steps S3 to S5 of FIG. 4, and the processing of steps S36 to S41 is FIG. This is the same as in steps S17 to S21 and step S11 of the above.
  • the induction method to be added to the electrocardiographic waveform measurement by lead I is not limited to the above-mentioned V4 lead, and various induction methods can be set. For example, if the control unit 104 determines that there is a possibility of atrial fibrillation (AF) as a result of the analysis of the electrocardiographic waveform in step S8, it is possible to make the determination of atrial fibrillation more reliable in the I lead. It is difficult, and it is preferable to check for the presence or absence of P wave or F wave (similar to irregular baseline). At this time, in step S32, remeasurement of the electrocardiographic waveform by V1 lead is added. Since the electrocardiographic waveform due to V1 lead is the waveform illustrated in FIG. 6 (D), the presence or absence of atrial fibrillation can be determined by adding V1 lead, which makes it easy to grasp the P wave and F wave, and remeasurement. , More useful electrocardiographic waveform data can be collected.
  • AF atrial fibrillation
  • FIGS. 8 and 9 are flowcharts illustrating a procedure for measuring a basic electrocardiographic waveform while BLE communication is performed between the portable electrocardiographic device 100 and a terminal equipped with a BLE communication function such as a smartphone 200. , 8 and 9 show a series of procedures.
  • the power is turned on by pressing the power switch 7 of the portable electrocardiographic device 100 (step S301).
  • the smartphone 200 opens the application for electrocardiographic measurement (step S401). The registration of the subject's ID and the like will be described as being completed at the time of the above-mentioned initial setting.
  • a BLE connection is made between the portable electrocardiographic device 100 and the smartphone 200 according to a predetermined procedure (step S302, step S402).
  • the smartphone 200 transmits a communication start request to the portable electrocardiographic device 100 (step S403).
  • FIG. 10A is a display example of the touch panel display 202 when the subject or the user inputs the guidance type setting on the smartphone 200.
  • a button 2022 for selecting a guidance method to be set from the plurality of types of guidance methods is displayed.
  • the button 2022 for selecting the guidance type includes a button corresponding to a plurality of types of guidance methods.
  • the button 2022 sets the button 2022a for setting the I lead, the button 2022b for setting the II lead, the button 2022c for setting the III lead, the button 2022d for setting the V1 lead, the button 2022e for setting the V2 lead, and the V3 lead.
  • the button 2022f for setting the V4 lead, the button 2022g for setting the V4 lead, the button 2022h for setting the V5 lead, and the button 2022i for setting the V6 lead are included.
  • the buttons 2022a to 2022i are labeled in relation to each induction method. For example, when the subject or the user selects the electrocardiographic measurement by V4 induction, he / she touches the button 2022g of the touch panel display 202.
  • the subject brings the electrode 2 of the portable electrocardiographic device 100 into contact with the touch panel display 202 according to the set lead method, as shown in FIG. 10 (B).
  • a guide screen 2023 for explaining the power position (measurement site) using figures and letters is displayed.
  • a guidance screen corresponding to V4 guidance is illustrated, but a similar guidance screen can be displayed for a guidance method that can be selected by the subject or the user.
  • the button 2022 including the buttons 2022a to 2022i corresponds to the setting unit of the present invention.
  • the guidance type set in step S404 is transmitted from the smartphone 200 to the portable electrocardiographic device 100.
  • the portable electrocardiographic device 100 receives the guidance type (step S303) and stores it in a predetermined area of the memory unit 106.
  • the control unit 104 detects the electrode contact state (step S304). Specifically, when the V4 induction measurement is performed by the portable electrocardiographic device 100, the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4. Then, the first electrode 2 is brought into contact with the skin slightly to the left of the epigastric region of the left chest and below the nipple. Further, when the I-lead measurement is performed by the portable electrocardiographic device 100, the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4.
  • the left palm is brought into contact with the first electrode 2.
  • the subject brings the electrodes 2, 3 and 4 into contact with the measurement site according to the set induction type.
  • the electric signal acquired via the electrodes 2, 3 and 4 is amplified by the amplifier unit 102 and digitally converted by the AD conversion unit to generate a contact state detection signal.
  • the contact state detection signal generated in this way is transmitted to the control unit 104 to detect the contact state between the subject and each of the electrodes 2, 3 and 4.
  • the portable electrocardiographic device 100 transmits information indicating the electrode contact state to the smartphone 200 (step S305).
  • the smartphone 200 receives the information indicating the electrode contact state (step S405)
  • the smartphone 200 displays the electrode contact state on the touch panel display 202 or the like (step S406), and the smartphone 200 is in normal contact with the electrodes 2, 3, and 4. Inform the examiner.
  • the control unit 104 determines whether or not a predetermined time has elapsed while the electrode contact state is maintained (step S306). If No is determined in step S306, the process returns to step S304. If it is determined to be Yes in step S306, the control unit 104 starts the electrocardiographic measurement according to the set induction type (step S307).
  • the portable electrocardiographic device 100 When the electrocardiographic measurement is started, the portable electrocardiographic device 100 performs streaming communication with the smartphone 200, and transmits the guidance type information, the electrocardiographic waveform information, and the measurement time information to the smartphone 200 (step S308).
  • the measurement time information is information related to the elapsed time from the start of electrocardiographic measurement, which is counted by the timer unit 105, and here, the remaining measurement time obtained by subtracting the elapsed time from the start of electrocardiographic measurement from a predetermined time. This is information indicating.
  • Information on the elapsed time from the start of electrocardiographic measurement may be transmitted from the portable electrocardiographic device 100 to the smartphone 200, and the smartphone 200 may perform subtraction processing from the predetermined time.
  • the smartphone 200 receives the guidance type information, the electrocardiographic waveform information, and the measurement time information from the portable electrocardiographic device 100 (step S407).
  • the guidance type, the electrocardiographic waveform, and the measurement time are displayed on the touch panel display 202 (step S408).
  • the subject is notified of the induction type, that the electrocardiographic measurement is performed normally, and the remaining measurement time.
  • the guidance type displayed on the touch panel display 202 can be used to instruct the subject on the correct measurement posture. Further, when the touch panel display 202 displays a guidance type different from the guidance method intended by the subject, it is possible to prompt the user to perform the measurement again in the correct measurement posture.
  • step S309 It is determined whether or not a predetermined measurement time (for example, 30 seconds) has elapsed since the measurement of the electrocardiographic waveform was started (step S309). If No is determined in step S309, the process returns to step S307 and the electrocardiographic measurement is continued. If it is determined to be Yes in step S309, the control unit 104 analyzes the electrocardiographic waveform according to the set predetermined induction method (step S310). By analyzing the electrocardiographic waveform according to the set predetermined induction method, accurate analysis becomes possible.
  • a predetermined measurement time for example, 30 seconds
  • the control unit 104 transmits information indicating that the electrocardiographic waveform is being analyzed to the smartphone 200 during the analysis of the electrocardiographic waveform (step S311).
  • the smartphone 200 receives the information indicating that the electrocardiographic waveform is being analyzed from the portable electrocardiographic device 100 (step S409), the smartphone 200 displays the information indicating that the electrocardiographic waveform is being analyzed on the touch panel display 202. (Step S410).
  • the control unit 104 stores the induction type, the electrocardiographic waveform, and the analysis result in a predetermined area of the memory unit 106 in association with each other (step S312).
  • the control unit 104 stores the induction type, the electrocardiographic waveform, and the analysis result in a predetermined area of the memory unit 106 in association with each other (step S312).
  • the induction type, the electrocardiographic waveform, and the analysis result associated with each other may not be stored in the memory unit 106 of the portable electrocardiographic device 100, but may be stored only on the smartphone 200 side.
  • the control unit 104 may blink the abnormal wave detection LED 13 to notify the subject of the abnormal wave detection.
  • the control unit 104 transmits the analysis result to the smartphone 200 by high-speed data communication (step S314).
  • the smartphone 200 receives the analysis result transmitted from the portable electrocardiographic device 100 (step S411), and detects an abnormal waveform as to whether the analysis result, that is, the electrocardiographic measurement result is normal and there is no problem. It is displayed on the touch panel display 202 (step S412).
  • the control unit 104 uses high-speed data communication to obtain such information from a new one.
  • the data is sequentially transmitted to the smartphone 200 (step S315).
  • the smartphone 200 receives the untransmitted electrocardiographic waveform data, the induction type data, and the analysis result from the portable electrocardiographic device 100 (step S413), and saves them in a predetermined area of the memory unit 204.
  • the smartphone 200 displays the latest electrocardiographic waveform and the analysis result such as whether the electrocardiographic measurement result is normal or an abnormal wave is detected on the touch panel display 202 (step S414).
  • step S316 When the transmission of the untransmitted electrocardiographic waveform data, the induction type determination result data, and the analysis result is completed in the portable electrocardiographic device 100 (step S316), in response to the communication end request (step S415) transmitted from the smartphone 200. , BLE communication is disconnected (step S317). Corresponding to the disconnection of the BLE communication in the portable electrocardiographic device 100, the BLE communication is also disconnected on the smartphone 200 side (step S416).
  • the power switch 7 is turned off in the portable electrocardiographic device 100 (step S318).
  • the power switch 7 may be automatically turned off by the control unit 104 after a lapse of a predetermined time after the BLE is disconnected, or may be turned off by pressing the power switch 7 by the subject or the user.
  • the smartphone 200 closes the application after disconnecting the BLE communication (step S417). In this way, the electrocardiographic measurement in cooperation with the smartphone 200 in the portable electrocardiographic device 100 is completed.
  • FIG. 11 and 12 show that the portable electrocardiographic device 100 and a terminal equipped with a BLE communication function such as a smartphone 200 measure an electrocardiographic waveform by one induction method while performing BLE communication, and then different induction methods. It is a flowchart explaining the procedure for measuring an electrocardiographic waveform by FIG. 11 and FIG. 12 shows a series of procedures. The same reference numerals are used for the processes common to the basic electrocardiographic waveform measurement processes shown in FIGS. 8 and 9, and detailed description thereof will be omitted.
  • steps S301 and S302 in the portable electrocardiographic device 100 and steps S401 to S403 in the smartphone 200 are the same as those shown in FIG. 8, so the description thereof will be omitted.
  • the control unit 201 accepts the input of the guidance type (step S604).
  • the I guidance is selected and input.
  • the subject or the user touches the button 2022a for setting the I guidance on the touch panel display 202 of the smartphone 200.
  • the I lead is set, as shown in FIG. 13 (A)
  • the subject brings the electrode 2 of the portable electrocardiographic device 100 into contact with the touch panel display 202 according to the set I lead.
  • a guide screen 2024 for explaining the power position (measurement site) using figures and characters is displayed.
  • a guidance screen corresponding to V4 guidance is illustrated, but a similar guidance screen can be displayed for a guidance method that can be selected by the subject or the user.
  • the subject By displaying the measurement site to be contacted with the electrode 2 according to the set guidance type on the touch panel display 202 of the smartphone 200, the subject can be brought into contact with the electrode 2 at an accurate position.
  • the button 2022 including the buttons 2022a to 2022i corresponds to the setting unit of the present invention.
  • the guidance type set in step S604 is transmitted from the smartphone 200 to the portable electrocardiographic device 100.
  • the portable electrocardiographic device 100 receives the guidance type (step S503) and stores it in a predetermined area of the memory unit 106.
  • the control unit 104 detects the electrode contact state (step S504). Specifically, when the I-lead measurement is performed by the portable electrocardiographic device 100, the tip of the index finger of the right hand is brought into contact with the second electrode 3, and the middle node of the index finger of the right hand is brought into contact with the third electrode 4. Then, the left palm is brought into contact with the first electrode 2. In this way, the subject brings the electrodes 2, 3 and 4 into contact with the measurement site according to the set induction type.
  • the electric signal acquired via the electrodes 2, 3 and 4 is amplified by the amplifier unit 102 and digitally converted by the AD conversion unit to generate a contact state detection signal.
  • the contact state detection signal generated in this way is transmitted to the control unit 104 to detect the contact state between the subject and each of the electrodes 2, 3 and 4.
  • the portable electrocardiographic device 100 transmits information indicating the electrode contact state to the smartphone 200 (step S505).
  • the smartphone 200 receives the information indicating the electrode contact state (step S605), the electrode contact state is displayed on the touch panel display 202 or the like (step S606), and the smartphone 200 is in normal contact with the electrodes 2, 3 and 4. Inform the examiner.
  • the control unit 104 determines whether or not a predetermined time has elapsed while the electrode contact state is maintained (step S506). If No is determined in step S506, the process returns to step S504. If it is determined to be Yes in step S506, the control unit 104 starts the electrocardiographic measurement by the set I lead (step S507).
  • the portable electrocardiographic device 100 When the electrocardiographic measurement is started, the portable electrocardiographic device 100 performs streaming communication with the smartphone 200, and transfers the guidance type information, the electrocardiographic waveform information, and the measurement time information indicating that the lead is I to the smartphone 200. Transmit (step S508).
  • the measurement time information is information related to the elapsed time from the start of electrocardiographic measurement, which is counted by the timer unit 105, and here, the remaining measurement time obtained by subtracting the elapsed time from the start of electrocardiographic measurement from a predetermined time. This is information indicating.
  • Information on the elapsed time from the start of electrocardiographic measurement may be transmitted from the portable electrocardiographic device 100 to the smartphone 200, and the smartphone 200 may perform subtraction processing from the predetermined time.
  • the smartphone 200 receives the guidance type information, the electrocardiographic waveform information, and the measurement time information from the portable electrocardiographic device 100 (step S607).
  • the guidance type, the electrocardiographic waveform, and the measurement time are displayed on the touch panel display 202 (step S608).
  • the subject is notified that the lead type is lead I, that the electrocardiographic measurement is performed normally, and the remaining measurement time.
  • step S509 It is determined whether or not a predetermined measurement time (for example, 30 seconds) has elapsed since the measurement of the electrocardiographic waveform was started (step S509). If No is determined in step S509, the process returns to step S507 and the electrocardiographic measurement is continued. If it is determined to be Yes in step S509, the control unit 104 analyzes the electrocardiographic waveform according to the set predetermined induction method (step S510). Accurate analysis is possible by analyzing the electrocardiographic waveform according to the set I lead.
  • a predetermined measurement time for example, 30 seconds
  • the control unit 104 transmits information indicating that the electrocardiographic waveform is being analyzed to the smartphone 200 during the analysis of the electrocardiographic waveform (step S511).
  • the smartphone 200 receives the information indicating that the electrocardiographic waveform is being analyzed from the portable electrocardiographic device 100 (step S609), the smartphone 200 displays the information indicating that the electrocardiographic waveform is being analyzed on the touch panel display 202. (Step S610).
  • the control unit 104 stores the induction type, the electrocardiographic waveform, and the analysis result, which are I leads, in a predetermined area of the memory unit 106 (step S512).
  • the control unit 104 stores the induction type, the electrocardiographic waveform, and the analysis result, which are I leads, in a predetermined area of the memory unit 106 (step S512).
  • the induction type, the electrocardiographic waveform, and the analysis result associated with each other may not be stored in the memory unit 106 of the portable electrocardiographic device 100, but may be stored only on the smartphone 200 side.
  • the control unit 104 may blink the abnormal wave detection LED 13 to notify the subject of the abnormal wave detection.
  • the control unit 104 transmits the analysis result to the smartphone 200 by high-speed data communication (step S514).
  • the smartphone 200 receives the analysis result transmitted from the portable electrocardiographic device 100 (step S611), and detects an abnormal waveform as to whether the analysis result, that is, the electrocardiographic measurement result is normal and there is no problem. It is displayed on the touch panel display 202 (step S612).
  • the control unit 104 determines whether or not there is an abnormality in the electrocardiographic waveform due to the I lead (step S515). If No is determined in step S515, the electrocardiographic measurement process is terminated, and the power is turned off by pressing the power switch 7 (step S516). If it is determined to be Yes in step S515, that is, if an abnormality is found in the electrocardiographic waveform due to lead I, the control unit 104 uses another lead method to measure the electrocardiogram with a more accurate lead method. The addition of the remeasurement by is transmitted to the smartphone 200 (step S517).
  • FIG. 13 (B) shows an example of the analysis result displayed on the touch panel display 202 when it is determined in step S515 that there is an abnormality in the electrocardiographic waveform due to lead I.
  • the touch panel display 202 displays the analysis result of the electrocardiographic waveform by the I lead.
  • the electrocardiographic waveforms of the electrocardiographic waveforms by different induction methods such as the analysis result display 2025 "arrhythmia is observed" and "please perform additional V4 lead measurement for accurate diagnosis”.
  • a display 2026 prompting remeasurement is made.
  • the control unit 104 that causes the display 2026 to prompt the remeasurement of the electrocardiographic waveform in the above corresponds to the remeasurement promotion unit of the present invention.
  • the touch panel display 202 that displays the display 2026 prompting the remeasurement of the electrocardiographic waveform by a different induction method corresponds to the display means of the present invention.
  • the smartphone 200 Display 2026 prompting the measurement of the electrocardiographic waveform by another induction method is performed on the touch panel display 202 of the above (step S613).
  • the smartphone 200 Display 2026 prompting the measurement of the electrocardiographic waveform by another induction method is performed on the touch panel display 202 of the above (step S613).
  • it is urged to perform electrocardiographic measurement by V4 induction.
  • the guidance type setting screen 2021 shown in FIG. 10 (A) is used. Is displayed. Subject or user consent (OK) to add another induction method, remeasurement of the electrocardiographic waveform by V4 lead, by touching the button 2022g to set V4 lead by the subject or user. Is acquired (step S614). In response to this, the smartphone 200 transmits information indicating that it is V4 lead as information of another lead type to the portable electrocardiographic device 100.
  • the touch panel display 202 responds to the set guidance method as shown in FIG. 10 (B). Then, a guide screen 2023 is displayed in which the subject explains the position (measurement site) to be brought into contact with the electrode 2 of the portable electrocardiographic device 100 by using figures and letters. As a result, the subject can bring the electrode 2 into contact with the accurate position, and can accurately measure the electrocardiographic waveform.
  • the portable electrocardiographic device 100 receives the information of another induction measurement (step 518). After that, electrocardiographic measurement by V4 lead, which is set as another lead method, is performed. Since the processing procedure after step S519 is the same as the processing procedure after step S304 and step S405 shown in FIGS. 8 and 9, the description thereof will be omitted.
  • the induction method to be added to the electrocardiographic waveform measurement by lead I is not limited to the above-mentioned V4 lead, and various induction methods can be set. For example, if the control unit 104 determines that there is a possibility of atrial fibrillation (AF) as a result of the analysis of the electrocardiographic waveform in step S518, it is possible to make the determination of atrial fibrillation more reliable in the I lead. It is difficult, and it is preferable to check for the presence or absence of P wave or F wave (similar to irregular baseline). At this time, in step S32, remeasurement of the electrocardiographic waveform by V1 lead is added. Since the electrocardiographic waveform due to V1 lead is the waveform illustrated in FIG. 6 (D), the presence or absence of atrial fibrillation can be determined by adding V1 lead, which makes it easy to grasp the P wave and F wave, and remeasurement. , More useful electrocardiographic waveform data can be collected.
  • AF atrial fibrillation
  • the electrocardiographic waveform pattern can be accurately measured, and useful information can be collected for accurate diagnosis.
  • An example of adding the remeasurement of the electrocardiographic waveform by the V4 lead to the electrocardiographic side measurement by the I lead and an example of adding the remeasurement of the electrocardiographic waveform by the V1 lead to the electrocardiographic measurement by the I lead have been described.
  • the induction method when re-measuring the electrocardiographic waveform in addition to the electrocardiographic measurement by is not limited to these.
  • the combination of the induction method when first measuring the electrocardiogram and the induction method when adding the remeasurement of the electrocardiographic waveform is not limited to these.
  • electrocardiographic measurement by one induction method if a good systematic analysis cannot be expected due to poor waveform quality, noisy noise, unclear waveform pattern, etc., a heart with characteristics that complement it.
  • the accuracy of the electrocardiographic measurement can be improved by adding the remeasurement of the electrocardiographic waveform by the induction method capable of measuring the radio wave shape.

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PCT/JP2021/009346 2020-03-19 2021-03-09 携帯型心電装置、心電計測システム、およびプログラム Ceased WO2021187247A1 (ja)

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DE112021000556.1T DE112021000556T5 (de) 2020-03-19 2021-03-09 Tragbare ektrokardiographische vorrichtung, ektrokardiogramm-messsystem und programm
US17/932,159 US20230011154A1 (en) 2020-03-19 2022-09-14 Portable electrocardiographic device, electrocardiogram measurement system, and non-transitory recording medium having program recorded therein

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JP2006061494A (ja) * 2004-08-27 2006-03-09 Omron Healthcare Co Ltd 携帯型心電計
JP2007195690A (ja) * 2006-01-25 2007-08-09 Matsushita Electric Works Ltd 携帯型心電計測装置
JP2010166961A (ja) * 2009-01-20 2010-08-05 Parama Tec:Kk 心電計
JP2015020050A (ja) * 2013-07-20 2015-02-02 株式会社Ｃｕ 心電計
JP2018161324A (ja) * 2017-03-27 2018-10-18 日本光電工業株式会社 携帯型医療用測定装置、及び、医療用測定プログラム

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