WO2024248049A1 - 心電計 - Google Patents

心電計 Download PDF

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Publication number
WO2024248049A1
WO2024248049A1 PCT/JP2024/019731 JP2024019731W WO2024248049A1 WO 2024248049 A1 WO2024248049 A1 WO 2024248049A1 JP 2024019731 W JP2024019731 W JP 2024019731W WO 2024248049 A1 WO2024248049 A1 WO 2024248049A1
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WO
WIPO (PCT)
Prior art keywords
normal
electrocardiogram
frequency range
electrocardiogram data
data
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2024/019731
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English (en)
French (fr)
Japanese (ja)
Inventor
嘉彦 佐野
証英 原田
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.)
Nipro Corp
Harada Electronics Industry Co Ltd
Original Assignee
Nipro Corp
Harada Electronics Industry Co Ltd
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Publication date
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Priority to EP24815530.1A priority Critical patent/EP4721666A1/en
Priority to JP2025524140A priority patent/JPWO2024248049A1/ja
Publication of WO2024248049A1 publication Critical patent/WO2024248049A1/ja
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
    • A61B5/316—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
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/30—Input circuits therefor
    • A61B5/307—Input circuits therefor specially adapted for particular uses
    • A61B5/308—Input circuits therefor specially adapted for particular uses for electrocardiography [ECG]
    • 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
    • A61B5/361—Detecting fibrillation
    • 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
    • A61B5/7203—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal
    • A61B5/7207—Signal processing specially adapted for physiological signals or for diagnostic purposes for noise prevention, reduction or removal of noise induced by motion artifacts
    • 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
    • A61B5/7225—Details of analogue processing, e.g. isolation amplifier, gain or sensitivity adjustment, filtering, baseline or drift compensation
    • 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
    • A61B5/7235—Details of waveform analysis
    • A61B5/725—Details of waveform analysis using specific filters therefor, e.g. Kalman or adaptive filters
    • 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
    • A61B5/7405—Details of notification to user or communication with user or patient; User input means using sound
    • 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

Definitions

  • This invention relates to an electrocardiograph that continuously records electrocardiogram data detected by bioelectrodes and indifferent electrodes over a long period of time in accordance with electrocardiogram standards, and that makes it possible to magnify the heartbeat waveform of the recorded electrocardiogram data.
  • a conventional electrocardiograph that continuously records electrocardiogram data detected by bioelectrodes and indifferent electrodes over a long period of time in accordance with electrocardiogram standards is, for example, the Holter electrocardiograph described in Patent Document 1.
  • This Holter electrocardiograph allows the input and recording of events while recording a Holter electrocardiogram, and allows editing of events and electrocardiograms when playing back a recorded Holter electrocardiogram, making it easier to understand the test results.
  • JIS-T-60601-2-47:2018 is known as the electrocardiogram standard for Holter ECG monitors, and this electrocardiogram standard stipulates that the frequency characteristics must satisfy the condition that the amplitude of a sine wave signal of 2 mVp-v from 0.67 Hz to 40 Hz must be within the range of 70% to 140% (-3 dB to +3 dB) with the amplitude at 5 Hz being 100%.
  • the frequency characteristics of Holter ECG monitors are usually 0.05 Hz to 100 Hz.
  • electrocardiogram data contains artifacts such as baseline drift caused by body movements such as breathing, and electrocardiogram data with these artifacts is recorded as an electrocardiogram.
  • artifacts occupy much of the data width of the dynamic range of electrocardiogram data (maximum data width usable for electrocardiogram data) DWs (e.g., 4096 digits) required by the electrocardiogram standard, and the data width DWi of individual heartbeat waveforms HW usable for electrocardiogram analysis as shown in FIG. 3(b) is a fraction of the data width DWs of the dynamic range of electrocardiogram data (e.g., about 400 digits), as shown in artifact-free period P2 in FIG. 3(a).
  • each heartbeat waveform HW is usually made up of a series of waveforms: waveform W1 called P wave, waveform W2 called Q wave, waveform W3 called R wave, waveform W4 called S wave, and waveform W5 called T wave.
  • waveform W1 called P wave
  • waveform W2 called Q wave
  • waveform W3 called R wave
  • waveform W4 called S wave
  • waveform W5 called T wave.
  • the data width DWi of the heartbeat waveform HW is only a fraction of the data width DWs of the dynamic range of the electrocardiogram data, so it is often difficult to distinguish small signals such as the first waveform W1, the P wave, from noise in the artifacts.
  • the purpose of this invention is therefore to provide an electrocardiograph that not only records electrocardiograms according to the standard, but also records electrocardiogram data with a sufficiently expanded heart rate waveform, enabling highly accurate electrocardiogram data analysis.
  • the electrocardiograph of the present invention which advantageously solves the above problems comprises: A normal filter that extracts electrocardiogram data in a normal frequency range based on electrocardiogram standards from the electrocardiogram data detected by the bioelectrodes and the indifferent electrodes; a normal channel data processing means for continuously recording and outputting the electrocardiogram data in the normal frequency range extracted by the normal filter over a long period of time; an additional filter that removes at least artifacts of baseline drift due to body movement by extracting electrocardiogram data in a predetermined frequency range having a lower limit frequency higher than the normal frequency range from the electrocardiogram data detected by the bioelectrodes and the indifferent electrodes; an additional channel data processing means for continuously recording and outputting the electrocardiogram data in a predetermined frequency range extracted by the additional filter over a long period of time;
  • the present invention is characterized by comprising:
  • the normal filter extracts electrocardiogram data in a normal frequency range based on electrocardiogram standards from the electrocardiogram data detected by the bioelectrodes and the indifferent electrodes, and the normal channel data processing means continuously records and outputs the electrocardiogram data in the normal frequency range extracted by the normal filter over a long period of time.
  • the additional filter removes at least artifacts of baseline drift due to body movement by extracting electrocardiogram data in a predetermined frequency range with a lower limit frequency higher than the normal frequency range from the electrocardiogram data detected by the bioelectrodes and the indifferent electrodes, and the additional channel data processing means continuously records and outputs the electrocardiogram data in the predetermined frequency range extracted by the additional filter over a long period of time.
  • a normal electrocardiogram such as a 24-hour Holter electrocardiogram based on electrocardiogram standards
  • a heartbeat waveform with a data width of, for example, approximately 3000 digits can be obtained from the output signal of the additional channel data processing means, which is expanded using at least the data width occupied by artifacts of baseline drift due to body movement, thereby making it possible to display each heartbeat waveform large and with high accuracy.
  • the additional filter extracts electrocardiogram data in a predetermined frequency range with a lower limit frequency higher than the normal frequency range from the electrocardiogram data detected by the bioelectrodes and the indifferent electrodes, thereby removing the baseline drift artifacts caused by the body movement, and extracts at least the R waves of each heartbeat waveform.
  • the additional channel data processing means continuously records and outputs the electrocardiogram data in the predetermined frequency range extracted by the additional filter over a long period of time, and may immediately record and output an atrial fibrillation warning signal if it detects variation in the intervals between the extracted R waves.
  • FIG. 1 is a block diagram showing a first embodiment of an electrocardiograph according to the present invention
  • FIG. 4 is a block diagram showing a second embodiment of an electrocardiograph according to the present invention
  • 1A is a relationship diagram showing the relationship between the level of electrocardiogram data of a normal channel of a Holter electrocardiograph under actual use conditions and the passage of time
  • FIG. 1B is a relationship diagram showing the relationship between the level of electrocardiogram data recorded and output by an additional channel data processing means in the electrocardiograph of the first embodiment and the passage of time.
  • Figure 1 is a block diagram showing a first embodiment of an electrocardiograph of the present invention, in which the symbol H in Figure 1 indicates the heart of a subject from which an electrocardiogram is to be obtained, BE1 and BE2 are bioelectrodes attached to the skin near the subject's heart H, and IE is an indifferent electrode attached to the skin near the subject's heart H at a position approximately equidistant from the bioelectrodes BE1 and BE2.
  • the electrocardiograph of the first embodiment comprises a bioamplifier 1 that amplifies the electrocardiographic data detected by the bioelectrodes BE1, BE2 and the indifferent electrode IE and outputs the data as an analog signal, a normal filter 2 that removes signals below frequency F1 and above frequency F3 from the electrocardiographic data output by the bioamplifier 1 based on normal electrocardiographic standards such as the 24-hour Holter electrocardiographic standard and outputs the remaining electrocardiographic data, an amplifier 3 that amplifies the electrocardiographic data output by the normal filter 2 at a low magnification corresponding to the data width DWs of the dynamic range of the electrocardiographic data to be recorded and outputs the a/d converter 4 that converts the analog signal of the electrocardiographic data output by the amplifier 3 into a digital signal with a sampling period of, for example, 4 ms and outputs the digital signal.
  • the frequency F1 is set to 0.05 Hz and the frequency F3 is set to 60 Hz based on the 24-
  • the electrocardiograph of the first embodiment also includes a first additional filter 5 that removes signals below frequency F2 and above frequency F3 from the electrocardiogram data output by the bioamplifier 1 and outputs the remaining electrocardiogram data, and an amplifier 6 that amplifies and outputs the electrocardiogram data output by the first additional filter 5 at a high magnification such that the data width DWi of the recorded heart rate waveform HW is expanded to close to the data width DWs of the dynamic range of the electrocardiogram data.
  • the analog signal of the electrocardiogram data output by the amplifier 6 is also converted by the A/D converter 4 to a digital signal with a sampling period of, for example, 4 ms and output.
  • the frequency F2 is set to 10 Hz in order to remove artifacts of baseline drift due to body movement from the electrocardiogram data detected by the bioelectrodes BE1, BE2 and the indifferent electrode IE.
  • the electrocardiograph of the first embodiment is equipped with a CPU (Central Processing Unit) 7, which controls the operation of the A/D converter 4 so as to convert the analog signals of the electrocardiogram data output by the amplifiers 3 and 6 into digital signals, for example at the above-mentioned sampling period of 4 ms, based on a previously given program, and outputs the electrocardiogram data of the digital signal output by the A/D converter 4 to the memory circuit 8, and the memory circuit 8 readably stores (records) the electrocardiogram data from the amplifier 3 among the electrocardiogram data in a memory element such as a memory of the normal channel memory circuit 8a, and readably stores (records) the electrocardiogram data from the amplifier 6 among the electrocardiogram data in a memory element such as a memory of the additional channel memory circuit 8b.
  • a CPU Central Processing Unit
  • the reading of the electrocardiogram data from the memory elements of the normal channel memory circuit 8a and the additional channel memory circuit 8b is preferably performed compactly and without contact by using a magnetic circuit configured by overlapping a pair of coils separably arranged with each other.
  • the amplifier 3, the A/D converter 4, the CPU 7, and the normal channel storage circuit 8a correspond to the normal channel data processing means
  • the amplifier 6, the A/D converter 4, the CPU 7, and the additional channel storage circuit 8b correspond to the additional channel data processing means
  • a normal electrocardiogram based on normal electrocardiogram standards such as the 24-hour Holter electrocardiogram standard as shown in FIG. 3(a)
  • a heartbeat waveform with a data width of, for example, approximately 3000 digits, which is expanded using at least the data width occupied by the artifact of baseline drift due to body movement, as shown in FIG.
  • FIG. 2 is a block diagram showing a second embodiment of the electrocardiograph of the present invention, and in FIG. 2, parts similar to those shown in FIG. 1 are indicated by the same reference numerals.
  • the electrocardiograph of the second embodiment shown in FIG. 2 includes, in addition to the configuration of the electrocardiograph of the first embodiment shown in FIG. 1, a second additional filter 9, an R-wave detector 10, a counter 11, an R-R measurement oscillator 12, and a signal input/output unit 13.
  • the second additional filter 9 outputs electrocardiogram data in which the R-wave of each heartbeat waveform HW is emphasized, which is obtained by removing signals below frequency F4 (e.g., 20 Hz) and above frequency F3 (e.g., 60 Hz) from the electrocardiogram data output by the bioamplifier 1.
  • the R-wave detector 10 detects the rising edge of the R-wave of each heartbeat signal of the electrocardiogram data output by the second additional filter 9 and outputs a pulse signal synchronized with the rising edge.
  • the counter 11 receives an R-R measurement signal of a frequency higher than the sampling period from the R-R measurement oscillator 12, measures the interval R-R of the pulse signal corresponding to the R-wave of adjacent heartbeat waveforms HW, and sends the measured interval R-R to the CPU 7.
  • the CPU 7 continuously calculates the root mean square (RMS) of the difference between the latest measured interval R-R and the previously measured interval R-R at predetermined intervals, judges whether the interval R-R varies greatly so that the RMS is equal to or greater than a predetermined threshold, and if the interval R-R varies greatly, causes the signal input/output unit 13 to output an atrial fibrillation warning signal, which causes the signal input/output unit 13 to immediately output a warning signal, for example, by an alarm sound from a speaker (not shown) or by displaying the screen of a smartphone via radio waves from the antenna 13a.
  • RMS root mean square
  • the electrocardiograph of this second embodiment in addition to the effects of the electrocardiograph of the first embodiment, there is an effect of being able to reliably detect the variation in the R-wave interval from the high-precision heartbeat waveform with an expanded data width, so that as an atrial fibrillation detector (AF detector), it can reliably detect the occurrence of atrial fibrillation in the subject's heart and immediately output a warning signal by sounding an alarm or displaying it on the screen of a mobile terminal such as a smartphone.
  • AF detector atrial fibrillation detector
  • the detection of the variation in the R-R interval may be performed using a method other than the root mean square (RMS).
  • the electrocardiogram standard used by the normal filter and normal channel data processing means is not limited to the 24-hour Holter electrocardiogram standard, and may be one that continuously records the electrocardiogram for an even longer period of time.
  • a high-frequency signal in the CPU 7 may be used instead of the R-R measurement transmitter 12.
  • the additional filter may have a frequency range through which the electrocardiogram data passes that is different from that of the first and second embodiments described above, and may only extract R waves.
  • a normal electrocardiogram such as a 24-hour Holter electrocardiogram based on electrocardiogram standards
  • a heartbeat waveform with an expanded data width can be obtained from the output signal of the additional channel data processing means, using at least the data width occupied by artifacts of baseline drift due to body movement, thereby allowing individual heartbeat waveforms to be displayed large and with high accuracy.

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PCT/JP2024/019731 2023-06-02 2024-05-29 心電計 Ceased WO2024248049A1 (ja)

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Application Number Priority Date Filing Date Title
EP24815530.1A EP4721666A1 (en) 2023-06-02 2024-05-29 Electrocardiograph
JP2025524140A JPWO2024248049A1 (https=) 2023-06-02 2024-05-29

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JP2023-091405 2023-06-02

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04352940A (ja) 1991-05-30 1992-12-08 Nec Corp ホルター心電計
JPH10216096A (ja) * 1997-02-04 1998-08-18 Matsushita Electric Ind Co Ltd 生体信号解析装置
JP2014128455A (ja) * 2012-12-28 2014-07-10 Fukuda Denshi Co Ltd 心電計

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6169919B1 (en) * 1999-05-06 2001-01-02 Beth Israel Deaconess Medical Center, Inc. System and method for quantifying alternation in an electrocardiogram signal
US8755877B2 (en) * 2012-03-12 2014-06-17 Texas Instruments Incoporated Real time QRS detection using adaptive threshold
CN107951485B (zh) * 2017-11-27 2019-06-11 深圳市凯沃尔电子有限公司 基于人工智能自学习的动态心电图分析方法和装置

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH04352940A (ja) 1991-05-30 1992-12-08 Nec Corp ホルター心電計
JPH10216096A (ja) * 1997-02-04 1998-08-18 Matsushita Electric Ind Co Ltd 生体信号解析装置
JP2014128455A (ja) * 2012-12-28 2014-07-10 Fukuda Denshi Co Ltd 心電計

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP4721666A4

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EP4721666A4 (en) 2026-04-08
EP4721666A1 (en) 2026-04-08

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