WO2021251088A1 - 除細動用電気装置、及び除細動信号の発生方法 - Google Patents

除細動用電気装置、及び除細動信号の発生方法 Download PDF

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Publication number
WO2021251088A1
WO2021251088A1 PCT/JP2021/019043 JP2021019043W WO2021251088A1 WO 2021251088 A1 WO2021251088 A1 WO 2021251088A1 JP 2021019043 W JP2021019043 W JP 2021019043W WO 2021251088 A1 WO2021251088 A1 WO 2021251088A1
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Prior art keywords
wave
time interval
time
defibrillation
predetermined time
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PCT/JP2021/019043
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English (en)
French (fr)
Japanese (ja)
Inventor
慎一郎 坂本
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Kaneka Corp
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Kaneka Corp
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Priority to CN202180039550.2A priority Critical patent/CN115884808A/zh
Priority to JP2022530092A priority patent/JP7688636B2/ja
Priority to US17/925,476 priority patent/US12478792B2/en
Publication of WO2021251088A1 publication Critical patent/WO2021251088A1/ja
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3987—Heart defibrillators characterised by the timing or triggering of the shock
    • 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]
    • A61B5/33—Heart-related electrical modalities, e.g. electrocardiography [ECG] specially adapted for cooperation with other devices
    • 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
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056—Transvascular endocardial electrode systems
    • A61N1/0563—Transvascular endocardial electrode systems specially adapted for defibrillation or cardioversion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3925—Monitoring; Protecting
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/395—Heart defibrillators for treating atrial fibrillation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39—Heart defibrillators
    • A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Definitions

  • the present invention relates to an electric device for defibrillation and a method for generating a defibrillation signal.
  • defibrillation is performed to restore the rhythm of the heart to normal by applying electrical stimulation.
  • AED automatic external defibrillator
  • ICD implantable cardioverter Defibrillator
  • defibrillation paddle system a defibrillation paddle system
  • defibrillation catheter system a defibrillation catheter system
  • Patent Document 1 describes a defibrillation catheter that is inserted into the heart cavity to perform defibrillation, and a DC voltage applied to the electrodes of the defibrillation catheter.
  • a catheter system with an applied power supply and an electrocardiograph is disclosed.
  • the present invention has been made in view of the above circumstances, and an object of the present invention is to provide a new electric device for defibrillation and a method for generating a defibrillation signal.
  • Electrocardiographic waveform input unit and It has a permit signal generator that generates a permit signal that permits the application of a voltage for defibrillation.
  • An electric device for definement which is characterized by satisfying the following requirement 1 or the following requirement 2. However, the following nth, n + 1th, and n + 2nd R waves are detected in this order, and n is an integer of 1 or more. (Requirement 1) After the first time interval, which is the time interval from the nth R wave to the n + 1st R wave of the electrocardiographic waveform, exceeds the first predetermined time, the n + 1th R wave from the permission signal generation unit.
  • the second time interval which is the time interval from the nth R wave to the n + second R wave of the electrocardiographic waveform, is the second predetermined time. After the time is exceeded, the permission signal is controlled to be generated for the n + 2nd R wave from the permission signal generation unit.
  • the interval between the R wave and the T wave that appears after the R wave in the electrocardiographic waveform is shorter than the interval between the R wave and the next R wave. Therefore, in the defibrillation electric device, the T wave included in the R wave detected by the requirement 1 can be surely excluded from the voltage application target. Further, even if the distance between the R waves is narrow, it becomes easy to select an appropriate R wave as a voltage application target according to the requirement 2, and a voltage for defibrillation can be applied.
  • the present invention also includes the following electric devices for definement of [2] to [10].
  • [2] Further having a power supply unit for generating an applied voltage, The defibrillation electric device according to [1], which is controlled to generate a permission signal from the permission signal generation unit after the permission signal generation unit is further controlled in the above requirement 1 or the above requirement 2 when the following requirement 3 is further satisfied.
  • (Requirement 3) Charging of the voltage required for voltage application is completed in the power supply unit.
  • the voltage for defibrillation is not applied to the R wave immediately before the R wave to which the permission signal for defibrillation is emitted.
  • the first time interval is the time interval from the peak of the nth R wave of the electrocardiographic waveform to the peak of the n + 1st R wave.
  • the second time interval is the time interval from the peak of the nth R wave of the electrocardiographic waveform to the peak of the n + second R wave, which is the reduction according to any one of [1] to [5].
  • Dynamic electrical equipment [7]
  • the height of the n + 1th R wave waveform is the first from the time when the height of the nth R wave waveform of the electrocardiographic waveform exceeds the first predetermined value. It is the time interval until the time when it exceeds the predetermined value of
  • the height of the n + second R wave waveform is the first predetermined value from the time when the height of the nth R wave waveform of the electrocardiographic waveform exceeds the first predetermined value.
  • the third predetermined time is shorter than the time interval from the start of the R wave to the peak.
  • the height of the n + 1th R wave waveform is the second from the time when the height of the nth R wave waveform of the electrocardiographic waveform falls below the second predetermined value. It is the time interval until the time when it falls below the predetermined value of
  • the height of the n + second R wave waveform is the second predetermined value from the time when the height of the nth R wave waveform of the electrocardiographic waveform is lower than the second predetermined value.
  • the present invention also includes the following [11] intracardiac defibrillation catheter system.
  • [11] A catheter that is inserted into the heart chamber and has a distal end and a proximal end and has a plurality of electrodes at the distal portion thereof.
  • An intracardiac defibrillation catheter system comprising the electrical device for defibrillation according to any one of [1] to [10], which applies a voltage to the plurality of electrodes.
  • the present invention also includes a method for generating a defibrillation signal according to the following [12].
  • n is an integer of 1 or more.
  • the T wave contained in the detected R wave can be reliably excluded from the voltage application target. Further, even if the distance between the R waves is narrow, it becomes easy to select an appropriate R wave as a voltage application target, and a voltage for defibrillation can be applied.
  • the T wave contained in the detected R wave can be reliably excluded from the voltage application target. Further, even if the distance between the R waves is narrow, it becomes easy to select an appropriate R wave as a voltage application target, and a voltage for defibrillation can be applied.
  • the defibrillation electrical device has an electrocardiographic waveform input unit and a permission signal generation unit that generates a permission signal that permits application of a voltage for defibrillation, and is described below. It meets Requirement 1 or Requirement 2 below. However, the following nth, n + 1th, and n + 2nd R waves are detected in this order, and n is an integer of 1 or more. (Requirement 1) After the first time interval, which is the time interval from the nth R wave to the n + 1st R wave of the electrocardiographic waveform, exceeds the first predetermined time, the permission signal generation unit becomes the n + 1th R wave.
  • the second time interval which is the time interval from the nth R wave to the n + second R wave of the electrocardiographic waveform, sets the second predetermined time. After that, the permission signal is controlled to be generated for the n + 2nd R wave from the permission signal generation unit.
  • the interval between the R wave and the T wave that appears after the R wave in the electrocardiographic waveform is shorter than the interval between the R wave and the next R wave. Therefore, in the defibrillation electric device, the T wave included in the R wave detected by the requirement 1 can be surely excluded from the voltage application target. Further, even if the distance between the R waves is narrow, it becomes easy to select an appropriate R wave as a voltage application target according to the requirement 2, and a voltage for defibrillation can be applied.
  • FIG. 1 is a schematic diagram showing a configuration of a defibrillation catheter system including an electric device for defibrillation according to the first embodiment of the present invention.
  • FIG. 2 is a diagram showing an example of an electrocardiographic waveform.
  • FIG. 3 is a flowchart showing a method of generating a defibrillation signal according to an embodiment of the present invention.
  • the solid line B extending in the time axis direction is the baseline of the electrocardiographic waveform.
  • the definement electric device 2 of FIG. 1 includes an electrocardiographic waveform input unit 3 and a permission signal generation unit 7.
  • the electrocardiographic waveform obtained from the body surface electrode 19 arranged on the body surface of the human body is input to the defibrillation electric device 2 from the electrocardiographic waveform input unit 3 via the electrocardiograph 40 or the like. It has become like.
  • the definement electric device 2 satisfies the above requirement 1 or requirement 2. Specifically, as shown in FIGS. 2 to 3, the first time interval T 1 which is the time interval from the nth R wave R n to the n + 1th R wave R n + 1 of the electrocardiographic waveform 50 is calculated.
  • step S1 It is determined whether or not the first time interval T 1 exceeds the first predetermined time (step S1).
  • the n + 1th R wave from the permission signal generation unit 7 is after the time when the first time interval T 1 exceeds the first predetermined time. It is controlled to generate a permit signal for defibrillation for R n + 1 (step S2).
  • the second time interval is from the nth R wave R n of the electrocardiographic waveform 50 to the n + second R wave R n + 2.
  • the time interval T 2 is calculated, and it is determined whether or not the second time interval T 2 exceeds the second predetermined time (step S3).
  • the n + second R wave from the permission signal generation unit 7 is after the time when the second time interval T 2 exceeds the second predetermined time. It is controlled to generate a permit signal for defibrillation for R n + 2 (step S4).
  • the nth, n + 1st, and n + 2nd R waves are detected in this order, and n is an integer of 1 or more.
  • the R wave detection method is not particularly limited in the requirements 1 and 2, and the R wave can be detected by a known method.
  • the first time interval T 1 is a time interval (unit: seconds) from the nth R wave R n to the n + 1th R wave R n + 1 in the electrocardiographic waveform 50.
  • the method for setting the first time interval T 1 is not particularly limited, but as shown in FIG. 2, the first time interval T 1 is n + 1 from the peak 51p of the nth R wave R n of the electrocardiographic waveform 50. It is preferable that the time interval is up to the peak 51p of the second R wave R n + 1. Since the peak position of the electrocardiographic waveform 50 can be easily specified, the first time interval T 1 can be calculated in a short time by such a method. As a result, the R wave to which the voltage is applied can be detected at an early stage, and the voltage can be applied to the patient at an early stage.
  • the first time interval T 1 it is also possible to use an interval between specific times other than the peaks of adjacent R waves.
  • the first time interval T 1 may be calculated by comparing the times before the peak in the adjacent R waves.
  • the first time interval T 1 is the n + 1th R wave R n + 1 from the time when the height of the nth R wave R n of the electrocardiographic waveform 50 exceeds the first predetermined value.
  • the height of the waveform of the above-mentioned waveform is a time interval until after the time point when the height exceeds the first predetermined value.
  • the first predetermined value is between the height of the waveform from the start 51s of the R wave to the peak 51p of the R wave.
  • the first predetermined value is set to, for example, 10% or more, 50% or more, or 90% or more. It may have been done.
  • the first time interval T 1 can be calculated at an early stage.
  • the first time interval T 1 may be a time interval from the start 51s of the nth R wave R n of the electrocardiographic waveform 50 to the start 51s of the n + 1th R wave R n + 1 .
  • the time point at which the height of the waveform of the nth R wave Rn exceeds the predetermined value means the time point at which the height exceeds the predetermined value first. The same applies to the following description.
  • the n + 1th R wave R n + 1 It may be a time interval until the height of the waveform of the above-mentioned second predetermined value falls below the above-mentioned second predetermined value.
  • the second predetermined value is between the heights of the waveforms from the peak 51p of the R wave to the end 51f.
  • the second predetermined value is, for example, 95% or less, 50% or less, or 20% or less. It may be set.
  • the first time interval T 1 may be the time interval from the end 51f of the nth R wave R n of the electrocardiographic waveform 50 to the end 51f of the n + 1th R wave R n + 1 .
  • the time point at which the height of the waveform of the nth R wave Rn falls below the predetermined value means the time point at which the height falls below the predetermined value first. The same applies to the following description.
  • the second time interval T 2 is a time interval (unit: seconds) from the nth R wave R n to the n + second R wave R n + 2 in the electrocardiographic waveform 50.
  • the method for setting the second time interval T 2 is not particularly limited, but as shown in FIG. 2, the first time interval T 1 is n + 1 from the peak 51p of the nth R wave R n of the electrocardiographic waveform 50.
  • the second time interval T 2 is the n + second R wave R n + 2 from the peak 51p of the nth R wave R n of the electrocardiographic waveform 50.
  • the time interval up to the peak 51p is preferable. Since the peak position of the electrocardiographic waveform 50 is easy to specify, the second time interval T 2 can be calculated in a short time by the above method as in the case of the first time interval T 1.
  • an interval between specific times other than the peak can be used.
  • th of the first time interval T 1 is ECG waveform 50 R n + 1
  • the second time interval T 2 is the height of the waveform of the nth R wave R n of the electrocardiographic waveform 50.
  • the time interval is from the time when the first predetermined value is exceeded to the time when the height of the waveform of the n + second R wave R n + 2 exceeds the first predetermined value.
  • the first time interval T 1 is the time when the height of the nth R wave R n of the electrocardiographic waveform 50 falls below the second predetermined value
  • the second time interval T 2 is the height of the waveform of the nth R wave R n of the electrocardiographic waveform 50. It may be a time interval from a time point below the second predetermined value to a time point at which the height of the waveform of the n + second R wave R n + 2 falls below the second predetermined value.
  • the second time interval T 2 May be the time interval from the start 51s of the nth R wave R n of the electrocardiographic waveform 50 to the start 51s of the n + second R wave R n + 2.
  • the second time interval T 2 may be a time interval from the end 51f of the nth R wave R n of the electrocardiographic waveform 50 to the end 51f of the n + second R wave R n + 2.
  • the first time interval T 1 and the second time interval T 2 can be calculated by the arithmetic processing control unit 8 described later.
  • the first predetermined time can be set according to the patient, but for example, it is preferably 100 msec or more, more preferably 150 msec or more, and further preferably 200 msec or more. Further, the first predetermined time is preferably 300 msec or less, more preferably 290 msec or less, and further preferably 280 msec or less.
  • the second predetermined time can be set according to the patient in the same manner as the first predetermined time, but for example, it is preferably 100 msec or more, more preferably 150 msec or more, and 200 msec or more. Is more preferable.
  • the second predetermined time is preferably 300 msec or less, more preferably 290 msec or less, and further preferably 280 msec or less.
  • the first predetermined time and the second predetermined time are preferably 100 msec or more, more preferably 150 msec or more, and further preferably 200 msec or more, respectively. Further, the first predetermined time and the second predetermined time are preferably 300 msec or less, more preferably 290 msec or less, and further preferably 280 msec or less, respectively. By setting the first predetermined time and the second predetermined time in this way, it becomes easy to select the R wave to be applied with the voltage from the detected R waves.
  • the fifth predetermined time (unit: msec) can be set to, for example, a time including an electrocardiographic waveform having 3 or more cycles and 10 or less cycles.
  • the first predetermined time and the second predetermined time can be set according to the characteristics of the electrocardiographic waveform of the patient. This is particularly effective for patients whose distance between R waves is narrow.
  • the first predetermined time and the second predetermined time are the same. As a result, even when the distance between the R waves is narrow, it becomes easy to select the R wave to be applied with the voltage from the detected R waves.
  • the first predetermined time and the second predetermined time may be different from each other.
  • the first predetermined time and the second predetermined time are stored in a memory described later. Further, these do not have to be stored in the same memory, and may be stored in different memories. In the definement electric device 2 according to the first embodiment, the first predetermined time and the second predetermined time are stored in the memory 5.
  • the permission signal is generated from the permission signal generation unit 7 only after the first time interval T 1 exceeds the first predetermined time.
  • the permission signal is generated within 60 msec from the time when the first time interval T 1 exceeds the first predetermined time, and it is more preferable that the permission signal is generated within 50 msec. It is even more preferred that the authorization signal be generated within seconds. It is also preferable to generate a permission signal when the first time interval T 1 exceeds the first predetermined time.
  • the permission signal is generated from the permission signal generation unit 7 only after the second time interval T 2 exceeds the second predetermined time.
  • the permission signal is generated within 60 msec from the time when the second time interval T 2 exceeds the second predetermined time, and it is more preferable that the permission signal is generated within 50 msec. It is even more preferred that the authorization signal be generated within seconds. It is also preferable to generate a permission signal when the second time interval T 2 exceeds the second predetermined time.
  • the permission signal generation unit 7 is controlled so that the permission signal is not generated.
  • the n + second R wave R n + 2 is re-recognized as the nth R wave R n, and the first time interval T 1 May be determined whether or not the first predetermined time has been exceeded.
  • the R wave detected next to the n + second R wave R n + 2 is the nth R wave.
  • R n It may be re-recognized as R n and it may be determined whether or not the first time interval T 1 exceeds the first predetermined time.
  • the R wave to be voltage-applied can be selected and the voltage can be appropriately applied. ..
  • the permission signal is not particularly limited as long as it is a signal relating to the application of a voltage for defibrillation. Examples include a switch-on permission signal for the switching unit 10. In the above requirement 1 or requirement 2, the permission signal generation unit 7 may generate at least one of these permission signals. On the other hand, some of these permission signals may be generated by the operation of the operation unit 6 described later.
  • the permission signal generation unit 7 is not limited to the arithmetic processing control unit 8 described later, and may be provided in the power supply unit 9 or the like.
  • the electrocardiographic waveform 50 as shown in FIG. 2 is displayed, for example, on the display unit of the electrocardiograph 40.
  • the electrocardiographic waveform 50 is preferably a waveform obtained by the second lead, which makes it easy to detect the R wave.
  • the electrocardiographic waveform 50 is not limited to the second lead, and may be obtained by other leads depending on the direction of the patient's heart.
  • the electrocardiographic waveform 50 is V1 lead, V2 lead, V3 lead, V4 lead, V5 lead, V6 lead, I lead, II lead, III lead, aVR lead.
  • AVL lead, or aVF lead may be the waveform obtained.
  • the electrocardiographic waveform 50 may be an average waveform of two or more leads, an average waveform of three or more leads, or an average waveform of 12 leads.
  • the definement electric device 2 further includes a power supply unit 9 for generating an applied voltage, and a permission signal is generated from the permission signal generation unit 7 after the requirement 1 or the requirement 2 further satisfies the following requirement 3. It is preferable that it is controlled so as to generate. (Requirement 3) In the power supply unit 9, charging of the voltage required for applying the voltage is completed.
  • the power supply unit 9 generates an applied voltage for defibrillation, and it is preferable that the power supply unit 9 is provided with a capacitor for charging the applied voltage as described later. For example, by operating the operation unit 6 described later, it is possible to control the charging of the capacitor to be started. By generating a permission signal after the defibrillation electric device 2 has finished charging the voltage required for applying the voltage in the power supply unit 9, it is possible to suppress defibrillation in a state of insufficient charging. can.
  • the power supply unit 9 includes at least one of a power supply, a booster circuit for boosting a DC voltage, a charging circuit, and a waveform generation circuit for generating a pulse voltage. At least a part of these may be provided outside the power supply unit 9.
  • the position of the power supply unit 9 is not particularly limited, and may be provided outside the arithmetic processing control unit 8 as shown in FIG. 1, or may be provided inside the arithmetic processing control unit 8.
  • the power supply unit 9 is connected to the arithmetic processing control unit 8.
  • the first time interval T 1 exceeds the first predetermined time, or the first time interval T 1 may be determined as the first predetermined time. It may be determined whether or not the above requirement 3 is satisfied, and then it is determined whether or not the above requirement 3 is satisfied.
  • the above requirement 3 is after determining whether the first time interval T 1 exceeds the first predetermined time, or after determining whether the second time interval T 2 exceeds the second predetermined time. It may be determined whether or not the condition is satisfied.
  • the definement electric device 2 is provided with an operation unit 6 for operating the charging of the capacitor.
  • the operation unit 6 known input means such as a button switch and a lever can be used.
  • the permission signal of a part of the above permission signals may be generated by the operation of the operation unit 6.
  • the operation unit 6 is connected to the power supply unit 9. As a result, the input signal from the operation unit 6 is transmitted to the power supply unit 9.
  • the operation unit 6 may be connected to the arithmetic processing control unit 8 described later. As a result, the input signal from the operation unit 6 is transmitted to the power supply unit 9 via the arithmetic processing control unit 8.
  • the definement electric device 2 is controlled so as to generate a permission signal from the permission signal generation unit 7 after the following requirement 4 is further satisfied in the above requirement 1 or the above requirement 2. .. (Requirement 4)
  • the voltage for defibrillation is not applied to the R wave immediately before the R wave to which the permission signal for defibrillation is emitted.
  • the defibrillation electric device 2 may have a memory 5 for storing whether or not a voltage for defibrillation has been applied to the R wave.
  • a known memory can be used, and for example, a volatile memory such as a random access memory and a non-volatile memory such as a flash memory can be included.
  • the memory 5 is preferably connected to the permission signal generation unit 7. As a result, the permission signal generation unit 7 can transmit a signal to the memory 5 indicating whether or not the voltage for defibrillation has been applied to which R wave.
  • the memory 5 is arranged outside the arithmetic processing control unit 8, and the memory 5 is connected to the arithmetic processing control unit 8. Although not shown, the memory 5 may be provided in the arithmetic processing control unit 8.
  • the above requirement 4 It may be determined whether or not the above requirement 4 is satisfied, and then whether or not the first time interval T 1 exceeds the first predetermined time, or the first time interval T 1 may be determined as the first predetermined time. It may be determined whether or not the above requirement 4 is satisfied, and then it is determined whether or not the above requirement 4 is satisfied. After determining whether the first time interval T 1 exceeds the first predetermined time, or after determining whether the second time interval T 2 exceeds the second predetermined time, the above requirement 4 It may be determined whether or not the condition is satisfied.
  • the definement electric device 2 may be controlled so that the voltage is not applied to the R wave detected next to the R wave to which the voltage is applied according to the requirement 1 or the requirement 2. Since it is possible to suppress the application of voltage to continuous R waves, the safety of the device can be improved.
  • the configuration may be such that the operator can confirm which waveform in the electrocardiographic waveform 50 corresponds to the R wave that can be the voltage application target. For example, after the first time interval T 1 exceeds the first predetermined time, it is controlled to generate a mark display signal for marking the n + 1th R wave R n + 1. , After the time when the second time interval T 2 exceeds the second predetermined time, it is controlled to generate a mark display signal for marking the n + second R wave R n + 2. It is preferable to have.
  • the above mark given to the R wave may be displayed on the display unit displaying the electrocardiographic waveform.
  • the description of the display unit 73 of the second embodiment described later can be referred to.
  • the defibrillation non-permitted mode is changed to the permitted mode. You can switch. This makes it easier to defibrillate and enhances safety.
  • the electric device for defibrillation 2 is preferably an electric device for intracardiac defibrillation.
  • Intracardiac defibrillator electrical devices can use lower energy voltage waveforms than extracorporeal defibrillators, reducing the burden on the patient and also during arrhythmia catheterization and ablation surgery. You can also do it.
  • FIG. 4 is a block diagram of a defibrillation catheter system 1 including an electric device for defibrillation 2 according to an embodiment of the present invention.
  • the present invention is a catheter 20 that is inserted into the heart cavity and has a distal end and a proximal end, the distal portion of which is provided with a plurality of electrodes.
  • An intracardiac defibrillation catheter system 1 comprising a catheter 20 and the defibrillation electrical device 2 that applies a voltage to a plurality of electrodes is included.
  • the proximal side of the catheter refers to the hand side of the operator (operator) with respect to the extending direction of the catheter, and the direction opposite to the distal side is the proximal side (that is, the direction of the treatment target side).
  • the proximal part of the catheter refers to the hand side half of the operator (operator) with respect to the extending direction of the catheter, and the distal part of the catheter is a part other than the proximal part (that is, the treatment target of the catheter). Point to the side half).
  • the electrocardiographic information obtained from the body surface electrode 19 arranged on the surface of the human body is transmitted to the electrocardiograph 40 via the first lead wire 31. It has become like.
  • the electrode for acquiring electrocardiographic information is not limited to the body surface electrode, and may be an electrode for measuring the intracardiac potential, but the body surface electrode is preferable because it has excellent R wave detection sensitivity.
  • As the body surface electrode an electrode for 12 leads is preferable.
  • the defibrillation electric device 2 of FIGS. 1 and 4 has a first connection portion 11 connected to a plurality of electrodes provided at the distal portion of the catheter 20 and a second connection portion 12 connected to the electrocardiograph 40. And a power supply unit 9 that generates an applied voltage, and a switching unit 10 that is connected to the power supply unit 9 and switches to an application mode in which a voltage is applied. Further, the first connection unit 11 is connected to the power supply unit 9 via the switching unit 10, and the first connection unit 11 is connected to the second connection unit 12 without passing through the switching unit 10. Since the first connecting portion 11 is connected to the second connecting portion 12 without passing through the switching portion 10, the local potential at each electrode can be measured even during defibrillation.
  • the definement electric device 2 includes an electrocardiographic waveform input unit 3, and the electrocardiographic waveform information output from the electrocardiograph 40 is internally transmitted from the electrocardiographic waveform input unit 3 via the second lead wire 32 or the like. It is designed to be entered in.
  • the electrocardiographic waveform input from the electrocardiographic waveform input unit 3 may be transmitted to the arithmetic processing control unit 8.
  • the arithmetic processing control unit 8 determines whether or not the first time interval T 1 exceeds the first predetermined time, and the second time interval T 2 exceeds the second predetermined time. It is possible to determine whether or not it is.
  • a permission signal generation unit 7 is provided in the arithmetic processing control unit 8. The permission signal generation unit 7 can generate a voltage application permission signal for the n + 1th R wave R n + 1 after the first time interval T 1 exceeds the first predetermined time.
  • the permission signal generation unit 7 n + 2 after the second time interval T 2 exceeds the second predetermined time.
  • a voltage application permission signal can be generated for the second R wave R n + 2.
  • the permission signal is transmitted to the power supply unit 9, and DC voltages having different polarities of positive and negative can be applied to the first electrode group 21 and the second electrode group 22.
  • the energization waveform may be biphasic in which the polarity is reversed in the middle, or may be monophasic in which the polarity is constant, but it is said that biphasic can be stimulated with less energy. Therefore, it is preferable.
  • the energizing energy applied to the living body can be set to, for example, 1 J or more and 30 J or less.
  • the defibrillation electric device 2 may have a display unit for displaying an electrocardiographic waveform, and the display unit may display a mark for an R wave. ..
  • the description of the display unit 73 of the second embodiment can be referred to.
  • the permission signal generation unit 7 may be controlled to generate a switch-on permission signal.
  • the permission signal is transmitted to the first switch 10A and the second switch 10B of the switching unit 10, and the first switch 10A and the second switch 10B can be changed from the off state to the on state, whereby the first electrode group 21 , The second electrode group 22 can be energized.
  • FIG. 4 when the switch constituting the switching unit 10 is in the off state, the first electrode group 21 and the second electrode group 22 are insulated from the power supply unit 9, so that defibrillation is not performed.
  • the intracardiac potential can be measured using the first electrode group 21 and the second electrode group 22.
  • At least one of the functions of the definement electric device 2 for example, the functions of the electrocardiographic waveform input unit 3, the memory 5, the permission signal generation unit 7, the arithmetic processing control unit 8, the power supply unit 9, and the switching unit 10 are. It may be realized by hardware or by software. Examples of the hardware include logic circuits formed in integrated circuits such as LSI (Large Scale Integration), ASIC (Application Specific Integrated Circuit), and FPGA (Field-Programmable Gate Array).
  • LSI Large Scale Integration
  • ASIC Application Specific Integrated Circuit
  • FPGA Field-Programmable Gate Array
  • the definement electric device 2 is software for realizing at least one of the functions of the electrocardiographic waveform input unit 3, the memory 5, the permission signal generation unit 7, the arithmetic processing control unit 8, the power supply unit 9, and the switching unit 10. It may be equipped with a computer that executes the instructions of the program.
  • the computer preferably includes a processor and a computer-readable recording medium that stores the above program.
  • the above functions are realized by the processor executing a program stored in a computer-readable recording medium.
  • a processor a CPU (Central Processing Unit) can be used.
  • a recording medium a ROM (Read Only Memory) or the like can be used.
  • the recording medium may include a RAM (Random Access Memory).
  • the program may be supplied to the computer via any transmission medium capable of transmitting the program. Examples of the transmission medium include a communication network and a communication line.
  • the switching unit 10 may have one or two or more switches. As shown in FIG. 4, the switching unit 10 preferably has a plurality of first switches 10A connected in parallel to each other and a plurality of second switches 10B connected in parallel to each other.
  • the catheter 20 has a first electrode group 21 and a second electrode group 22
  • the first electrode group 21 is connected to the power supply unit 9 via the first switch 10A, respectively
  • the second electrode group It is preferable that each of the 22 is connected to the power supply unit 9 via the second switch 10B. That is, it is preferable that the first electrode group 21 and the second electrode group 22 are connected to the power supply unit 9 via different switches.
  • each electrode group can be electrically separated, so that the intracardiac potential can be independently acquired in each electrode group.
  • the defibrillation electric device 2 has a third electrode group 23, which is a dedicated electrode for measuring the intracardiac potential, on the proximal side of the first electrode group 21 and the second electrode group 22. May be. Since the third electrode group 23 is located on the proximal side, it can be arranged at a position corresponding to, for example, the ascending aorta. It is preferable that the third electrode group 23 is not connected to the power supply unit 9. This makes it easier to use the third electrode group 23 as a dedicated electrode for measuring the intracardiac potential.
  • the number of electrodes constituting each electrode group is not particularly limited, and each electrode group may be the same or different. Above all, it is preferable that the number of electrodes constituting the first electrode group 21 and the number of electrodes constituting the second electrode group 22 are the same. Thereby, the surface areas of the first electrode group 21 and the second electrode group 22 can be easily made the same. By having the same surface area of each first electrode group 21 and each second electrode group 22 and evenly arranging the same number of electrodes, efficient defibrillation can be performed and the heart can be defibrillated. The accuracy of electrocardiogram measurement can be improved.
  • the number of electrodes constituting the third electrode group 23 is preferably less than or equal to the number of electrodes constituting the first electrode group 21 and the number of electrodes constituting the second electrode group 22.
  • the number of electrodes in the first electrode group 21 and the second electrode group 22 can be eight, and the number of electrodes in the third electrode group 23 can be four.
  • a resin tube 27 can be mentioned.
  • the first electrode group 21 and the second electrode group 22 can be provided at the distal portion of the resin tube 27.
  • Each electrode group preferably exists in a region of half or more of the outer circumference of the resin tube 27, and more preferably formed in a ring shape.
  • Each electrode group may contain a conductive material such as platinum or stainless steel, but in order to make it easier to grasp the position of the electrode under fluoroscopy, it contains an X-ray opaque material such as platinum. It is preferable to have.
  • a tip tip 25 may be provided at the distal end of the catheter 20.
  • the tip 25 preferably has a tapered portion whose outer diameter decreases toward the distal side.
  • the tip 25 may contain a conductive material.
  • the tip 25 can function as an electrode.
  • the tip 25 may be made of a polymer material.
  • the hardness of the tip 25 may be lower than the hardness of the resin tube 27 in order to protect the internal tissue from contact with the catheter 20.
  • An operation wire or a spring member for bending the distal side of the catheter 20 may be arranged in the lumen of the resin tube 27. Specifically, the distal end of the operation wire is fixed to the distal end of the resin tube 27 or the tip tip 25, and the proximal end of the operation wire is fixed to the handle 26 described later. preferable.
  • the third lead wire 33 (lead wire) is connected to each electrode group.
  • the other end of the third conductor 33 connected to the first electrode group 21 and the second electrode group 22 is preferably connected to the first connection portion 11 of the definement electric device 2.
  • the other end of the third conductor 33 connected to the third electrode group 23 is preferably connected to the third connection portion 13 of the definement electric device 2.
  • the third conductor 33 may be a plurality of conductors connected by a connecting member such as a connector.
  • the third connecting portion 13 and the fourth connecting portion 14 are connected via the seventh conducting wire 37.
  • the seventh conductor 37 may be a wiring material or may be a part of a wiring pattern provided on the printed circuit board.
  • the first connecting portion 11 and the switching portion 10 are connected via the fifth conducting wire 35.
  • the first electrode group 21 and the second electrode group 22 are connected to the power supply unit 9, so that a voltage can be applied.
  • the first electrode group 21, the second electrode group 22, and the power supply unit 9 may be connected via different connecting members such as connectors.
  • the second connection portion 12 is connected to the other end of the fourth conductor 34 connected to the input terminal of the electrocardiograph 40 corresponding to the first electrode group 21 and the second electrode group 22. Further, it is preferable that the second connecting portion 12 is connected to the fifth conducting wire 35 by the sixth conducting wire 36. It is preferable that the fifth conductor 35 and the sixth conductor 36 are not provided with a switch portion. Thereby, even during defibrillation, the intracardiac potential can be measured through the first electrode group 21 and the second electrode group 22.
  • the fifth conductor 35 and the sixth conductor 36 may be a wiring material or may be a part of a wiring pattern provided on the printed circuit board.
  • a handle 26 that the operator grips when operating the catheter 20 may be provided on the proximal side of the resin tube 27.
  • the shape of the handle 26 is not particularly limited, but has a frustum-shaped portion whose outer diameter decreases toward the distal side in order to alleviate stress concentration at the connection point between the resin tube 27 and the handle 26. Is preferable.
  • the electrocardiograph 40 measures the intracardiac potential through various electrodes.
  • a known electrocardiograph 40 can be used.
  • the definement electric device 2 may have an electrode selection switch for selecting an electrode to which a voltage is applied. As a result, electrical stimulation can be applied only to a specific electrode.
  • the position where the electrode selection switch is provided is not particularly limited, but it is preferable that the electrode selection switch is connected to the power supply unit 9, and it is more preferable that the electrode selection switch is provided in the arithmetic processing control unit 8.
  • the electrode selection switch may be provided separately from the switches constituting the switching unit 10 (for example, the first switch 10A and the second switch 10B), and at least one of the switches constituting the switching unit 10 is the electrode selection switch. You may. Further, although not shown, the definement electric device 2 may be provided with a safety switch.
  • the safety switch is preferably connected between the switching unit 10 and the power supply unit 9, and more preferably connected between the arithmetic processing control unit 8 and the switching unit 10.
  • the definement electric device 2 may be provided with a protection circuit that absorbs a high voltage generated when the switch is cut off. This can prevent damage to each switch.
  • the definement electric device 2 may be provided with an overvoltage protection circuit that protects the electrocardiograph 40 from overvoltage between the power supply unit 9 and the electrocardiograph 40. This makes it possible to prevent the electrocardiograph 40 from being damaged by the application of an overvoltage.
  • the definement electric device 2 may have an impedance measurement circuit.
  • the impedance measurement circuit is preferably connected, for example, between the first electrode group 21 and the second electrode group 22 so as to measure the impedance between the first electrode group 21 and the second electrode group 22.
  • FIG. 5 is a block diagram of the definement electric device 70 according to the second embodiment.
  • the same components as those of the definement electric device 2 according to the first embodiment are designated by the same reference numerals, and the description thereof will be omitted.
  • the electrocardiographic information input from the electrocardiographic waveform input unit 3 is the A / D converter 71, and the first arithmetic processing control unit. It is preferable that the electrocardiographic waveform is displayed on the display unit 73 via 72 (CPU).
  • the electrocardiographic information input from the electrocardiographic waveform input unit 3 is transmitted to the comparator 74 for comparing the heights of the waveforms, and when the electrocardiographic waveform exceeds a set predetermined value, the first is predetermined time 1 is transmitted to the second arithmetic processing control unit such as the second predetermined time is set 75 (FPGA), the later when the first time interval T 1 exceeds the first predetermined time
  • a signal is transmitted to the arithmetic processing control unit 75 (FPGA) of 2
  • a mark display signal is generated from the second arithmetic processing control unit 75 (FPGA)
  • the marking display signal is the first arithmetic processing control unit 72 (CPU).
  • the mark is displayed on the display unit 73 for the R wave after being transmitted to.
  • the shape of the mark include a polygon such as a circle, a triangle, and a quadrangle, and a linear shape.
  • the position where the mark is displayed include the peak of the R wave.
  • the mark display signal may be generated from the first arithmetic processing control unit 72 (CPU) as long as the mark is displayed on the display unit 73 with respect to the R wave.
  • the definement electric device 70 preferably includes a display unit 73 that displays an electrocardiographic waveform.
  • the display unit 73 is controlled so that the mark display signal for marking the R wave is generated from the mark display signal generation unit 76 after the second predetermined time is exceeded. ..
  • the mark is added to the R wave on the display unit 73 in this way, the operator can visually confirm the state of the R wave to which the voltage is applied.
  • the definement electric device 70 can switch the inside of the second arithmetic processing control unit 75 (FPGA) from the non-permitted mode to the permitted mode by operating the operation unit 6. .. Further, at the same time as switching the mode, the applied energy amount may be set, the applied energy may be charged to the capacitor, or the charging may be completed. May be. Further, the pulse voltage may be automatically generated after the charging is completed.
  • the non-permitted mode is a mode in which a permit signal related to defibrillation is not generated even if the time interval between R waves satisfies the predetermined time or the like described in the above requirement 1 or the above requirement 2.
  • the permission mode is a mode in which a permission signal related to defibrillation is generated when the time interval between R waves satisfies the predetermined time or the like described in the above requirement 1 or the above requirement 2.
  • the operator can switch to the non-permitted mode when the application of defibrillation energy is not appropriate and switch to the permitted mode after the application of defibrillation energy is required, so that defibrillation can be performed more safely. can do.
  • the permit signal relating to defibrillation the description of the first embodiment can be referred to.
  • the electrocardiographic information input from the electrocardiographic waveform input unit 3 is transmitted to the comparator 74 for comparing the heights of the waveforms, and the electrocardiographic waveform is set to a predetermined value.
  • a signal is transmitted to the second arithmetic processing control unit 75 (FPGA) in which the first predetermined time, the second predetermined time, etc. are set, and the first time interval T 1 is the first predetermined time. After the time is exceeded, or after the first time interval T 1 is equal to or less than the first predetermined time and the second time interval T 2 exceeds the second predetermined time.
  • the permission signal is generated from the second arithmetic processing control unit 75 (FPGA).
  • the period from the electrocardiographic waveform input unit 3 to the permission signal generation unit 7 is composed of a hardware circuit. Since the hardware circuit is a circuit in which signal processing is not performed by software, signal processing becomes faster. As a result, the time from the acquisition of the electrocardiographic information to the generation of the permission signal can be shortened.
  • the signal from the electrocardiographic waveform input unit 3 to the permission signal generation unit 7 may be an analog signal or a digital signal.
  • At least one of the functions of the definement electric device 70 for example, an electrocardiographic waveform input unit 3, a comparator 74, a permission signal generation unit 7, a first arithmetic processing control unit 72, and a second.
  • Functions such as the arithmetic processing control unit 75, the arithmetic processing control unit 8, the power supply unit 9, and the switching unit 10 may be realized by hardware or software.
  • the description of the first embodiment can be referred to.
  • the present invention also includes a method of generating a defibrillation signal.
  • the method for generating a defibrillation signal according to an embodiment of the present invention is, for example, as shown in FIG. 2, a time interval from the nth R wave R n of the electrocardiographic waveform to the n + 1th R wave R n + 1.
  • the first time interval T 1 is the step of determining whether more than a first predetermined time interval T 1 first time exceeds a first predetermined time After that time, a permission signal is generated in synchronization with the n + 1th R wave R n + 1 , and when the first time interval T 1 is equal to or less than the first predetermined time, the nth R wave R n to n + 2
  • the second time interval T 2 which is the time interval up to the second R wave R n + 2 , is calculated to determine whether or not the second time interval exceeds the second predetermined time, and the second time interval is described above.
  • n is an integer of 1 or more.
  • the method for generating a defibrillation signal further includes, for example, a step of determining whether or not the following requirement 3 is satisfied. (Requirement 3) Charging of the voltage required for applying the voltage in the power supply unit 9 is completed.
  • the method for generating a defibrillation signal further includes, for example, a step of determining whether or not the following requirement 4 is satisfied. (Requirement 4) The voltage for defibrillation is not applied to the R wave immediately before the R wave to which the permission signal for defibrillation is emitted.
  • Each of the above steps can be executed by using, for example, the definement electric device 2, the arithmetic processing control unit of the definement electric device 70, the memory, the comparator, the power supply unit, and the like.
  • the description of each requirement of the definement electric device 2 and the definement electric device 70 can be referred to.
  • each step in one defibrillation electric device, and each step may be executed in a separate device.
  • Electrocardiographic waveform input unit 5 Memory 6: Operation unit 7: Allowed signal generation unit 8: Arithmetic processing control unit 9: Power supply unit 10: Switching unit 10A: 1st switch 10B: 2nd switch 11: 1st connection part 12: 2nd connection part 13: 3rd connection part 14: 4th connection part 19: body surface electrode 20: catheter 21: 1st electrode group 22: 2nd Electrode group 23: 3rd electrode group 25: Tip tip 26: Handle 27: Resin tube 31: 1st conductor 32: 2nd conductor 33: 3rd conductor 34: 4th conductor 35: 5th conductor 36: 6th conductor 37 : 7th conductor 40: Electrocardiograph 50: Electrocardiographic waveform R n : nth R wave R n + 1 : n + 1st R wave R n + 2 : n + 2nd R wave 51f: End of R wave 51p: Peak of R wave 51s: Start of R

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JP2007516815A (ja) * 2004-01-21 2007-06-28 カーディオネット， インコーポレイテッド 心臓モニタリング
JP2012101027A (ja) * 2010-10-14 2012-05-31 Murata Mfg Co Ltd 拍動周期算出装置およびこれを備えた生体センサ
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JP6632511B2 (ja) 2016-11-04 2020-01-22 日本ライフライン株式会社 心腔内除細動カテーテルシステム
KR20210100156A (ko) * 2018-12-27 2021-08-13 니혼라이프라인 가부시키가이샤 심강 내 제세동 카테터 시스템

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JPH01110345A (ja) * 1987-09-30 1989-04-27 Chinese Pla General Hospital 電気刺激により心臓特性を検出する装置および方法
JP2007516815A (ja) * 2004-01-21 2007-06-28 カーディオネット， インコーポレイテッド 心臓モニタリング
JP2012101027A (ja) * 2010-10-14 2012-05-31 Murata Mfg Co Ltd 拍動周期算出装置およびこれを備えた生体センサ
US20170312534A1 (en) * 2016-04-29 2017-11-02 Medtronic, Inc. Multi-threshold sensing of cardiac electrical signals in an extracardiovascular implantable cardioverter defibrillator

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