WO2017061386A1 - 心拍同期型の血液循環補助システム、制御方法及び心拍同期型の電気刺激装置 - Google Patents

心拍同期型の血液循環補助システム、制御方法及び心拍同期型の電気刺激装置 Download PDF

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Publication number
WO2017061386A1
WO2017061386A1 PCT/JP2016/079325 JP2016079325W WO2017061386A1 WO 2017061386 A1 WO2017061386 A1 WO 2017061386A1 JP 2016079325 W JP2016079325 W JP 2016079325W WO 2017061386 A1 WO2017061386 A1 WO 2017061386A1
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Prior art keywords
wave
output
blood circulation
electrical signal
period
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PCT/JP2016/079325
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English (en)
French (fr)
Japanese (ja)
Inventor
健一郎 佐々木
博夫 松瀬
敏夫 森谷
志郎 神谷
龍二 秋本
力 細木
Original Assignee
学校法人 久留米大学
株式会社ホーマーイオン研究所
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Application filed by 学校法人 久留米大学, 株式会社ホーマーイオン研究所 filed Critical 学校法人 久留米大学
Priority to JP2017505682A priority Critical patent/JP6150963B1/ja
Priority to KR1020177003393A priority patent/KR101809635B1/ko
Priority to CN201680002507.8A priority patent/CN108025172B/zh
Publication of WO2017061386A1 publication Critical patent/WO2017061386A1/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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/3625—External stimulators
    • 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
    • A61N1/18—Applying electric currents by contact electrodes
    • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting
    • A61N1/3702—Physiological parameters
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36003—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of motor muscles, e.g. for walking assistance
    • 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
    • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/36014—External stimulators, e.g. with patch electrodes
    • A61N1/3603—Control systems
    • A61N1/36034—Control systems specified by the stimulation parameters

Definitions

  • the present invention relates to a blood circulation assist system and an electrical stimulation device for assisting blood circulation, and a method for controlling the blood circulation assist system.
  • Assisted cardiovascular therapy is a treatment method for abnormal conditions in blood circulation such as heart failure.
  • Cardiac assisted circulatory therapy is a method of improving hemodynamics and ameliorating a medical condition by a physical / physiological approach.
  • IABP intracardiac balloon pumping
  • EECP enhanced extracorporeal counterpulsation
  • a balloon placed in the descending aorta is inflated and deflated according to the heartbeat.
  • the balloon is dilated in the descending aorta during the diastole of the heart, the amount of blood flowing into the coronary artery, the heart's nutritional vessel, increases.
  • the balloon which had been expanded during the systole of the heart, is deflated, the pressure in the artery decreases.
  • the augmented extracorporeal counterpulsation method inflates and contracts a pant-type balloon that covers the lower limbs according to the heart beat, compresses the lower limb arteries, and releases the compression of the lower limb arteries. .
  • the pants are inflated, the amount of blood flowing into the coronary artery, which is the heart's nutritional blood vessel, increases.
  • the pants contract the compression of the lower limb artery is released and the pressure in the artery decreases. In this way, by inflating and deflating the pant-type balloon, the heart can easily push out blood, and blood circulation can be assisted similarly to the intra-aortic balloon pumping method.
  • the intra-aortic balloon pumping method an insertion port for inserting the balloon into the brachial artery or femoral artery is opened in order to place the balloon in the descending aorta. That is, the intra-aortic balloon pumping method is an open treatment method and has a high degree of invasiveness to the patient. During the placement of the balloon in the blood vessel, the blood coagulant must be administered continuously, increasing the risk of bleeding complications. There is also a problem that it is easy to cause complications such as infectious diseases because it is open.
  • a strong strong stimulus is applied to the skin surface of the lower limbs by frequently contracting and expanding the pant-type balloon for a certain period of time. Therefore, there is a problem that complications such as skin erosion and ulcer are likely to occur.
  • the present invention has been made in view of such circumstances.
  • an electrical signal of the blood circulation assist system is provided. It is an object of the present invention to provide a method for controlling a blood circulation assistance system that can maintain the output timing of the blood circulation in an optimum state.
  • a human blood circulation assistance system for solving the above-described problems includes an “electric stimulation device” that outputs an electric signal that is a pulse wave to at least the lower leg of the human body, and an electrocardiogram from the human body. Analyzing the electrocardiogram waveform acquired by the electrocardiogram data acquisition device and the electrocardiogram data acquisition device that continuously acquire the shape, and determining the output timing of the electrical signal output from the electrical stimulation device "Electrocardiographic data analysis device”. The electrocardiogram data analyzer determines a timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform as the output timing. The predetermined time is a time obtained by multiplying a period T which is a period of the R wave by 0.075 to 0.35.
  • the period T can be the period closest to the R wave.
  • the electrocardiogram data analyzer can determine the output timing each time the R wave is detected.
  • the electrocardiogram data analysis apparatus determines the output timing when the R wave is detected, and outputs the output even when the R wave is detected. A process that does not determine the timing can be alternately repeated.
  • the electrical stimulation device can further output the electrical signal to the thigh of the human body.
  • the output time of the electrical signal within the period T can be 0.15 to 0.25 seconds.
  • the control method of the blood circulation assistance system which provides an electrical stimulus to the said human body and assists blood circulation by outputting the electrical signal which is a pulse wave to at least the lower leg part of the human body according to the present invention.
  • the electrocardiogram waveform is continuously acquired from the human body, the acquired electrocardiogram waveform is analyzed, and the timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform is determined as the output timing of the electric signal.
  • the predetermined time is a time obtained by multiplying the period T, which is the period of the R wave, by 0.075 to 0.35.
  • An electrical stimulation device for applying electrical stimulation to the human body includes an electrical signal output unit that outputs an electrical signal composed of a pulse wave in synchronization with an electrocardiographic waveform detected from the human body, An electrode for transmitting the electrical signal to at least the lower leg of the human body, and the electrical signal output unit outputs the electrical signal at an output timing delayed by a predetermined time from the R wave included in the electrocardiographic waveform.
  • the predetermined time is the time obtained by multiplying the period T, which is the period of the R wave, by 0.075 to 0.35.
  • a blood circulation assist system and an electrical stimulation device that are unlikely to cause complications often observed in the existing systems as described above and that do not adversely affect the self-rhythming cardiac contraction / expansion function.
  • a control method for a blood circulation assist system that can keep the output timing of electrical signals of the blood circulation assist system in an optimal state.
  • FIG. 1 is a functional block diagram of the blood circulation assist system 1 of the present embodiment, and a dotted arrow indicates a transmission direction of a signal or the like.
  • the blood circulation assistance system 1 of the present embodiment includes an electrical stimulation device 100 that outputs an electrical signal for applying electrical stimulation to at least the lower leg of the human body P, and an electrocardiogram that detects a continuous electrocardiographic waveform from the human body P.
  • the data acquisition device 200 calculates the time obtained by multiplying the period T, which is the period of the R wave included in the electrocardiogram waveform, by 0.075 to 0.35 to determine the output timing of the electric signal, and at the output timing
  • the electrocardiogram data analysis apparatus 300 that outputs a trigger signal for operating the electrical stimulation apparatus 100 can be configured.
  • the electrocardiogram data acquisition apparatus 200 includes an electrocardiogram data acquisition unit 201.
  • the electrocardiogram data acquisition unit 201 acquires electrocardiogram data including a continuous electrocardiogram waveform from a detection electrode (not shown) fixed on the body surface of the human body P (that is, continuously acquires the electrocardiogram waveform). .)
  • the electrocardiogram data acquisition unit 201 outputs the acquired electrocardiogram data to the electrocardiogram data analyzer 300.
  • the electrocardiogram data acquisition apparatus 200 can be configured by an electrocardiograph, for example.
  • the acquisition of electrocardiographic data and the output of electrocardiographic data can be performed by wireless communication means and / or wired communication means.
  • the electrocardiogram data analysis apparatus 300 includes an analysis unit 301 and a trigger signal generation unit 302 as shown in FIG.
  • the analysis unit 301 includes a timer 301a. However, the timer 301a may be provided outside the analysis unit 301.
  • the analysis unit 301 performs an analysis process for analyzing the electrocardiogram data output from the electrocardiogram data acquisition unit 201 and determines the output timing of the electric signal based on the count result of the timer 301a. Further, the analysis unit 301 transmits information including the determined output timing to the trigger signal generation unit 302.
  • the trigger signal generation unit 302 generates a trigger signal for causing the electrical stimulation device 100 to output an electrical signal at the output timing transmitted from the analysis unit 301. Further, the trigger signal generation unit 302 outputs the generated trigger signal to the electrical stimulation device 100.
  • the acquisition of the electrocardiogram data output from the electrocardiogram data acquisition unit 201 and the output of the trigger signal generated by the trigger signal generation unit 302 can be performed by wireless communication means and / or wired communication means.
  • FIG. 2 is a flowchart showing a procedure of processing performed by the electrocardiogram data analysis apparatus 300.
  • FIG. 3 is a timing chart corresponding to the flowchart of FIG. 2.
  • the upper timing chart schematically represents an electrocardiogram waveform detected from the human body P, and the lower timing chart is synchronized with the electrocardiogram waveform. The waveform of the electric signal output in this way is schematically shown.
  • step S31 the analysis unit 301 analyzes the electrocardiogram data output from the electrocardiogram data acquisition unit 201, and determines whether or not an R wave included in the electrocardiogram waveform is detected. If the R wave is detected (YES in step S31), the process proceeds to step S32. If the R wave is not detected (NO in step S31), the process of step S31 is repeated again.
  • the R wave is a wave that appears when the ventricle contracts. As shown in FIG. 3, the R wave has a larger amplitude than the P wave, Q wave, S wave, and T wave included in the electrocardiogram waveform (in other words, the voltage (potential) is the largest).
  • step S32 the analysis unit 301 starts the timer 301a, and the process proceeds to step S33.
  • R-wave of the left-most electrocardiographic waveform of the four electrocardiographic waveform shown in FIG. 3 when it is detected in step S31 starts the timer 301a at the count time t 1 at step S32.
  • step S33 the analysis unit 301 determines whether or not the next R wave is detected. For example, if the R wave of the leftmost electrocardiogram waveform is detected in step S31, it is determined whether or not the next R wave, that is, the R wave of the second electrocardiogram waveform from the left is detected in step S33. To do. If the next R wave is detected (YES at step S33), the process proceeds to step S34. If the next R wave is not detected (NO at step S33), the process at step S33 is repeated again.
  • step S34 the analysis unit 301 measures the count time when the next R wave is detected in step S33. For example, if the R-wave of the second electrocardiographic waveform from the left in step S33 is detected, t 2 in step S34 is determined as the count time.
  • step S35 the analysis unit 301 determines the interval from the time when the timer 301a is started to the time when the next R wave is detected, that is, the period T (second) of the R wave. For example, if the count time in step S32 and step S34 are t 1 and t 2, respectively, (the time obtained by subtracting the t 2 at t 1) t 2 -t 1 is determined as the period T.
  • step S36 the analysis unit 301 calculates a time obtained by multiplying the period T determined in step S35 by 0.075 to 0.35, and 0.075 to 0.35 in the period T from the time when the R wave is detected.
  • the analysis unit 301 determines the time-delayed timing multiplied by as the output timing of the electrical signal. For example, when the R wave of the leftmost electrocardiogram waveform is detected in step S31 and the R wave of the second electrocardiogram waveform from the left is detected in step S33, the R wave of the second electrocardiogram waveform from the left is detected.
  • the numerical value to be multiplied by the period T is in a range of 0.075 to 0.35 by operating an operation unit (not shown) provided in the electrocardiogram data analysis apparatus 300 or an operation unit 14 of the electrical stimulation apparatus 100 described later. Can be set as appropriate.
  • step S37 the analysis unit 301 determines whether or not the output timing determined in step S36 has come from the time of the timer 301a.
  • the output timing is a timing delayed from the R wave of the second electrocardiogram waveform from the left by multiplying 0.02-0.35 by t 2 -t 1 which is the latest cycle of the R wave. Is determined, it is determined whether or not the time of u 1 has been reached. If it is determined that the output timing has been reached (YES in step S37), the process proceeds to step S38. If it is not determined that the output timing has been reached (NO in step S37), the process of step S37 is performed. Repeat again.
  • step S38 the trigger signal generation unit 302 generates a trigger signal that causes the electrical stimulation device 100 to output an electrical signal at the electrical signal output timing determined in step S37, and outputs the trigger signal to the electrical stimulation device 100.
  • an electrical signal is immediately output from the electrical signal output unit 101 that has received the trigger signal.
  • step S39 the analysis unit 301 determines whether or not a treatment stop signal has been input. If it is determined that a treatment stop signal has been input (YES in step S39), the timer 301a is stopped in step S40 and the analysis process is terminated.
  • the analysis unit 301 is, for example, when a treatment stop switch provided in the electrical stimulation apparatus 100 is pressed, or when the electrocardiographic data acquisition apparatus 200, the electrocardiographic data analysis apparatus 300, and the electrical stimulation apparatus 100 are powered down. When the switch is turned off, it can be determined that a treatment stop signal has been input.
  • step S39 when the treatment stop signal is not input (NO in step S39), the process returns to step S33, and time u 2 , u 3 ... Until the treatment stop signal is input.
  • the electrical stimulation synchronized with the electrocardiogram waveform is performed at the timing.
  • the period T is determined from two consecutive electrocardiographic waveforms. However, an average value of the period T (seconds) is calculated from three or more consecutive electrocardiographic waveforms, and this is determined as the period T. You can also
  • the trigger signal may include information regarding output timing. In this case, the trigger signal generation unit 302 immediately outputs the generated trigger signal to the electrical stimulation device 100, and the electrical signal output unit 101 does not output the electrical signal until the output timing included in the trigger signal is reached.
  • the electrical stimulation device 100 includes an electrical signal output unit 101 and an electrode 102.
  • the electrical signal output unit 101 outputs an electrical signal based on the trigger signal output from the trigger signal generation unit 302.
  • the electrode 102 transmits the electrical signal output by the electrical signal output unit 101 to the human body P.
  • the electrical stimulation device 100 includes a storage unit 13, an operation unit 14, a power supply unit 15, and a display unit 16.
  • the storage unit 13 is configured to output an electric signal continuously for each R wave of a continuous electrocardiogram waveform, the frequency, pulse width, output time, current value, and output pattern of the electric signal output from the electric signal output unit 101.
  • Various information regarding the energization method such as whether or not to output is stored.
  • the operation unit 14 includes an operation switch for switching the electrical stimulation device 100 on and off, and a setting button for setting an energization method.
  • the power supply unit 15 supplies power to each component of the electrical stimulation device 100.
  • the display unit 16 can display information such as an energization method.
  • the electrical signal output unit 101 includes an output control unit 12 that controls the output timing and energization mode of the electrical signal, and an output port 11 that generates and outputs an electrical signal based on control by the output control unit 12. Yes.
  • the output control unit 12 includes a microcomputer.
  • the output control unit 12 controls an energization mode of the electrical signal generated and output by the output port 11 based on a signal output from the operation unit 14 or the like.
  • the output control unit 12 controls the output timing of the electrical signal based on the trigger signal input from the electrocardiogram data analysis apparatus 300 (trigger signal generation unit 302).
  • the output control unit 12 causes the output port 11 to generate and output an electrical signal simultaneously with the input of the trigger signal.
  • the output control unit 12 causes the output port 11 to generate and output an electrical signal after the output timing is reached.
  • Electrical signal output unit 101 outputs an electrical signal that is a pulse wave.
  • the output time of the electric signal may be less than the time obtained by multiplying the period T by 0.65, and can be set as appropriate by those skilled in the art. For example, it is preferably 0.15 to 0.25 seconds.
  • the pulse width of the electric signal is not particularly limited, but can be, for example, 200 ⁇ sec to 300 ⁇ sec.
  • the current value of the electric signal transmitted to the lower leg cannot be determined uniquely because it is affected by the muscle mass or the like, but it can be set to 20 mA to 30 mA as an example.
  • a person skilled in the art can appropriately set the frequency of the electric signal, but it is preferably 20 Hz to 30 Hz, for example.
  • An electrical signal having a frequency of 20 Hz or more is likely to continue to compress the artery, and a pulse wave having a frequency of 30 Hz or less is likely to respond to the motor nerves and tend to contract the muscles.
  • the electrode 102 is provided with a right electrode portion 60 attached to the right side of the human body P and a left electrode portion 61 attached to the left side of the human body P.
  • These electrode portions 60 and 61 are provided with at least two positive and negative electrodes including a + electrode and a ⁇ electrode.
  • These two positive and negative electrodes can be attached to the ankle and thigh lower part (on the knee) of the human body P, respectively.
  • the + electrode and the ⁇ electrode of the right electrode portion 60 are attached to the lower right thigh and the right ankle of the human body P, respectively
  • the + electrode and the ⁇ electrode of the left electrode portion 61 are the lower thigh of the human body P. And the left ankle.
  • an electrical signal is transmitted to the part from the ankle to the lower thigh of the human body P, that is, at least the lower leg of the human body P.
  • the configuration and the mounting method of the electrode 102 are not limited to the configuration and the mounting method as long as an electrical signal can be transmitted to at least the lower leg of the human body P.
  • the positive and negative electrodes of the electrode portions 60 and 61 can be attached to the ankle and knee, respectively.
  • the electrode 102 can be configured to transmit an electrical signal to the thigh of the human body P in addition to the lower thigh of the human body P.
  • the electrode portions 60 and 61 can include at least three positive and negative electrodes respectively attached to the ankle, thigh, and waist. These three positive and negative electrodes are configured to include at least a positive electrode and a negative electrode, and are attached so that the polarity of the positive and negative electrodes attached to the ankle and the waist is different from the polarity of the positive and negative electrodes attached to the thigh. A specific example will be described.
  • a positive electrode When a positive electrode is attached to the right thigh of the positive and negative electrodes of the right electrode portion 60, a negative electrode is attached to the right waist and right ankle of the human body P, respectively.
  • the positive and negative electrodes of the left electrode portion 61 when the + electrode is attached to the left thigh of the human body P, the-electrode is attached to the left waist and the left ankle, respectively.
  • the electrode 102 is configured and mounted in this manner, an electrical signal is transmitted to a region from the ankle to the waist of the human body P, that is, at least the lower leg and thigh of the human body P.
  • the configuration and mounting method of the electrode 102 are not limited to the configuration and the mounting method as long as an electrical signal can be transmitted to the lower leg and thigh of the human body P.
  • a negative electrode can be attached to the knee
  • a positive electrode can be attached to the waist and ankle.
  • the lower leg refers to the part from the knee of the human body P to the ankle
  • the thigh refers to the part above the knee of the human body P to the base of the leg of the human body P (buttock).
  • the current value of the electrical signal transmitted to the thigh cannot be determined uniquely because it is affected by the muscle mass or the like, but can be set to, for example, 25 mA to 35 mA.
  • the positive and negative electrodes of the electrode parts 60 and 61 may be covered with a nonconductive member, and the conductive member may be provided only on the contact surface with the human body P. Further, the positive and negative electrodes of the electrode portions 60 and 61 may have a belt-like configuration so as to be wound around the human body P. Note that the number, size, and shape of the positive and negative electrodes of the electrode portions 60 and 61 can be changed according to the wearing site, the body shape of the human body P, and the like.
  • FIG. 5 is a diagram showing a processing flow of the blood circulation assist system 1.
  • step S71 an electrocardiographic waveform is continuously detected from the human body P.
  • step S72 the electrocardiographic waveform detected in step S71 is analyzed, and a time obtained by multiplying the period T, which is the period of the R wave, by 0.075 to 0.35 is calculated.
  • step S73 the timing delayed from the R wave calculated in step S72 is determined as the output timing of the electric signal.
  • step S74 an electrical signal is output at the output timing determined in step S73.
  • the electrocardiogram data acquisition device 200, the electrocardiogram data analysis device 300, and the electrical stimulation device 100 perform the processing shown in FIG. It can also be configured to perform only with the stimulation device 100.
  • the electrical signal is output at an output timing delayed by a time period obtained by multiplying the period T by 0.075 to 0.35 from the R wave included in the electrocardiogram waveform. .
  • the electrical signal output at this timing is transmitted to the lower leg and causes muscle contraction of the lower leg at a predetermined timing in the diastole of the heart (muscle pump action).
  • the lower leg arteries are compressed by the muscle contraction of the lower leg caused at this predetermined timing, and the arterial blood in the lower leg is removed at a timing when the arterial blood tends to flow into the coronary artery, which is the heart's nutritional blood vessel.
  • the action of pushing back toward the heart occurs.
  • the heart can easily pump blood, and the circulation of blood flowing through the human body P can be assisted.
  • the blood circulation assist effect described above is based on the improvement of the blood pump function of the heart, it does not hinder blood circulation (recirculation), and does not adversely affect the self-tuning cardiac contraction expansion function.
  • FIG. 6 is a diagram showing an arterial pressure waveform of the brachial artery of the human body P that continuously outputs the electrical signal for each R wave of the continuous electrocardiogram waveform, and the horizontal axis is time (seconds).
  • the vertical axis represents pressure (mmHg).
  • the support waveform W10 is confirmed in the arterial waveform W1 for at least one heartbeat among the arterial pressure waveforms detected from the human body P from which the electrical signal is output. If it can, it can be determined that the blood circulation assistance based on the improvement of the blood pump function of the heart is achieved.
  • the arterial pressure waveform of FIG. 6C when the support waveform W10 cannot be confirmed in the detected arterial pressure waveform W2, blood circulation assistance based on the improvement of the blood pump function of the heart is performed. It can be determined that it is not done.
  • the support waveform W10 is a signal obtained from the human body P and cannot be determined uniquely because there is a difference between individuals.
  • the support waveform W10 is shown in the arterial pressure waveforms in FIGS. 6 (A) and 6 (B).
  • the augmentation pressure P11 is preferably higher than the systolic blood pressure P10 as shown in FIG.
  • the systole means a period from T10 (T20) when the aortic valve is open to T11 (T21) when the aortic valve is closed, and the diastole is the period from T11 (T21) when the aortic valve is closed.
  • the period until T13 (T23) when the aortic valve is opened is shown.
  • the time T10 (T20) when the aortic valve is opened indicates the time when the diastolic blood pressure P12 (P22) is measured, and the time T13 (T23) when the next aortic valve is opened is the next to the diastolic blood pressure P12 (P22).
  • the aortic valve closing time T11 (T21) indicates a time when the dichroic notch D (D ') is measured.
  • the conventional intra-aortic balloon pumping method or augmented extracorporeal counterpulsation method that assists in blood circulation has a problem that it is highly invasive and easily causes complications such as infections, ulcers, etc. There was a problem that it was easy to cause complications.
  • blood circulation assistance system 1 of the present embodiment blood circulation can be assisted only by outputting an electrical signal to the lower leg at a predetermined timing. In addition to being able to do so, there is no excessive impact on the human body P. Therefore, it is difficult to cause complications such as infections and ulcers.
  • the output time of the electric signal within the period T is preferably 0.15 seconds to 0.25 seconds.
  • the compression of the lower leg artery is released, and the resistance in the artery decreases (intraarterial resistance). If the electrical signal output time is 0.15 to 0.25 seconds, the resistance in the artery (pressure in the artery) tends to decrease during the systole of the heart. This makes it easier for the heart to drain blood from the heart (left ventricle) into the artery (as if the blood in the heart (left ventricle) is drawn into the arterial blood vessel), causing blood to flow into the artery.
  • the burden is easily reduced (lower self-systolic blood pressure). That is, the blood pump function of the heart is assisted. Therefore, in the blood circulation assistance system 1 of the present embodiment, when the output time of the electrical signal is 0.15 seconds to 0.25 seconds, in addition to the improvement of the cardiac blood pump function described above, the cardiac blood pump function Based on this assistance, blood circulation can be assisted.
  • the blood circulation assist effect obtained by setting the electrical signal output time to 0.15 to 0.25 seconds is based on the improvement and assistance of the blood pump function of the heart. It is difficult to adversely affect the self-rhythming systolic dilation function.
  • FIG. 7 is a diagram showing an arterial pressure waveform of the brachial artery of the human body P that outputs an electrical signal every other R wave of the continuous electrocardiographic waveform.
  • An arterial pressure waveform W3 (W4) shown in FIG. 7 indicates an arterial pressure waveform corresponding to an electrocardiographic waveform from which an electric signal is output, and has a support waveform W30 (W40).
  • An arterial pressure waveform W3 '(W4') shown in FIG. 7 indicates an arterial pressure waveform corresponding to an electrocardiographic waveform from which no electrical signal is output. As shown in FIG.
  • the diastolic blood pressure P31 corresponds to the electrocardiographic waveform for which no electrical signal is output.
  • the pressure waveform W3 ′ is less than the diastolic blood pressure P30, in addition to the blood circulation assistance effect based on the improvement of the heart blood pump function, the blood circulation assistance effect based on the assistance of the heart blood pump function is obtained. Can be determined.
  • FIG. 7A shows that in the arterial pressure waveform W3 for at least one heartbeat among the arterial pressure waveforms having the support waveform W30, the diastolic blood pressure P31 corresponds to the electrocardiographic waveform for which no electrical signal is output.
  • the diastolic blood pressure P41 is an diastolic period of the arterial pressure waveform W4 ′ corresponding to an electrocardiographic waveform from which no electrical signal is output.
  • blood pump function is not limited to the above-described method, and is continuous.
  • the determination can also be made by confirming the arterial pressure waveform of the brachial artery of the human body P that has continuously output electrical signals for each R wave of the electrocardiographic waveform. Specifically, the diastolic blood pressure of the human body P when no electrical signal is output is detected, and this diastolic blood pressure is set as the reference diastolic blood pressure.
  • an arterial pressure waveform of the human body P when an electric signal is continuously output for each R wave of the continuous electrocardiographic waveform is detected, and an artery having a support waveform among the detected arterial pressure waveforms.
  • the diastolic blood pressure of the pressure waveform is set as the target diastolic blood pressure.
  • the target diastolic blood pressure is compared with the reference diastolic blood pressure described above. If the target diastolic blood pressure is less than the reference diastolic blood pressure, the blood circulation assist effect based on the improvement of the blood pump function of the heart is achieved. In addition, it can be determined that an effect of assisting blood circulation based on the assistance of the blood pump function of the heart is obtained. On the other hand, when the target diastolic blood pressure is equal to or higher than the reference diastolic blood pressure, it can be determined that the blood circulation assist effect based on the assistance of the blood pump function of the heart is not obtained.
  • the blood circulation assist system 1 of the present embodiment is configured to output an electrical signal at an output timing delayed from the R wave by multiplying the period T nearest to the R wave by 0.075 to 0.35.
  • an electric signal can be output at an output timing determined based on the latest period T. Therefore, even if the heart beats irregularly, the output electrical signal can be accurately synchronized with the heartbeat (electrocardiogram waveform).
  • the electrocardiogram data analysis apparatus 300 is configured to determine the output timing each time an R wave is detected, an electrical signal is generated every time the heart beats (every time an electrocardiogram waveform is detected). It is output and can assist blood circulation every time the heart beats. It is also possible to continuously increase the cardiac output.
  • the output time of the electrical signal output from the electrical stimulation device 100 corresponding to each output timing is 0.15 to 0.25 seconds
  • the output time of the electrical signal is 0.15 to 0.
  • the artery can be reliably compressed.
  • the output time of the electrical signal is set to 0.15 to 0.25 seconds
  • blood circulation can be assisted more reliably.
  • the cardiac output can be further increased.
  • the output time of the electrical signal output from the electrical stimulation device 100 is 0.15 to 0.25 seconds, the electrical signal is likely to be output at the output timing determined by the electrocardiogram data acquisition device 300. .
  • the muscle contraction time is shorter than when the output time is 0.15 seconds or more, so that sufficient muscle tension to compress the artery is obtained. May not be possible. In such a case, the artery is less likely to be compressed.
  • the output time of the electrical signal exceeds 0.25 seconds, the electrical signal is less likely to be output at the output timing determined by the electrocardiogram data acquisition device 300 as compared to the case where the output time is 0.25 seconds or less. It may be.
  • a person whose heart rate is excessively faster than a normal heart rate has a short period T, and therefore, when the output time of an electric signal is longer than 0.25 seconds, As soon as the output of the electrical signal ends, the output timing of a new electrical signal may be reached. In such a case, it may be difficult to output an electrical signal at the determined output timing.
  • the electrical stimulation device 100 is configured to output an electrical signal to the thigh of the human body P in addition to the lower thigh, the arteries of the lower thigh and thigh can be compressed. That is, as compared with the blood circulation assist system 1 in which an electrical signal is output only to the lower leg, more arteries can be compressed, so that blood circulation can be further assisted. In addition, the cardiac output can be further increased.
  • the output timing of the electrical signal of the blood circulation assistance system can be maintained in an optimum state as described above.
  • the timing delayed by multiplying the period T of the R wave by 0.075 to 0.35 relative to the R wave is the output timing of the electric signal.
  • the output timing of the electric signal may be any timing delayed from the R wave by multiplying the R wave period T by 0.075 to 0.35.
  • the timing may be delayed from the R wave by multiplying 0.075 to 0.35 by the period T that is not the most recent period of the R wave.
  • the output timing of the electric signal is determined as such output timing. Even at such an output timing, blood circulation can be assisted without adversely affecting the self-tuning cardiac contraction / expansion function.
  • steps S46 to S55 described below for example, the R wave of the leftmost electrocardiographic waveform shown in FIG. 9 is detected in step S41, and the second electrocardiogram from the left is detected in step S43. It is assumed that this is a step relating to processing after the R wave of the shape is detected and t 2 -t 1 (seconds) is determined as the period T in step S45. Steps S41 to S45 are the same as steps S31 to S35 of the above-described embodiment, and detailed description thereof is omitted.
  • step S46 the analysis unit 301 calculates a time obtained by multiplying t 2 -t 1 (seconds) determined in step S45 by 0.075 to 0.35.
  • the process for calculating the time obtained by multiplying the period T by 0.075 to 0.35 and the process for determining the output timing of the electric signal are performed separately.
  • step S47 the analysis unit 301 determines whether or not the third electrocardiographic R wave from the left is detected.
  • step S47 YES the process proceeds to the process of step S48. If the R wave of the third electrocardiogram waveform from the left is not detected (step S47: NO), step S47 is repeated again.
  • step S48 the time delay time obtained by multiplying the R wave of the third electrocardiogram waveform from the left by t 2 -t 1 (seconds) by 0.075 to 0.35, that is, the time of u 1 is the electric time.
  • the analysis unit 301 determines the signal output timing.
  • the analysis unit 301 counts the time t 3 when detected the R wave of the third electrocardiographic waveform from left to measure.
  • step S50 the analysis unit 301 calculates the period t 3 -t 2 (seconds) of the R wave of the second electrocardiogram waveform from the left and the R wave of the third electrocardiogram waveform from the left from the time of step S44 and step S49. Will be determined.
  • step S51 the analysis unit 301 calculates a time obtained by multiplying t 3 -t 2 (seconds) by 0.075 to 0.35.
  • step S52 whether it is the output timing determined in step S48 (time u 1) analyzing unit 301 determines. If it is determined that the time of u 1 has been reached (YES in step S52), the process proceeds to step S53. If it is not determined that the time of u 1 has been reached (NO in step S52), the process proceeds to step S53. The process of S52 is repeated again.
  • step S ⁇ b> 53 the trigger signal generation unit 302 generates a trigger signal at the time u 1 and outputs the trigger signal to the electrical stimulation device 100.
  • step S54 it is determined whether or not a treatment stop signal has been input. If it is determined that a treatment stop signal has been input (YES in step S54), the timer 301a is stopped in step S55 to perform analysis processing. Exit. If it is not determined in step S54 that a treatment stop signal has been input (NO in step S54), the process returns to step S47 and the subsequent steps are repeated. In the next repeated step S48, the timing of the rightmost electrocardiographic waveform R delayed by a time obtained by multiplying t 3 -t 2 (seconds) by 0.075 to 0.35, that is, the time of u 2 . Is determined as the output timing of the electrical signal.
  • Modification 2 of the blood circulation assistance system 1 of the present embodiment will be described with reference to FIGS. 10 and 11.
  • the output timing is determined so as to continuously output the electrical signal for each R wave of the continuous electrocardiogram waveform (that is, In this modification, the electrical signal is output every other R wave of the continuous electrocardiogram waveform in succession.
  • the output timing is determined (that is, the process of determining the output timing when the R wave is detected and the process of not determining the output timing even when the R wave is detected are alternately repeated). Even if an electrical signal is output at such an output timing, blood circulation can be assisted without adversely affecting the self-tuning cardiac contraction / expansion function.
  • steps S81 and S90 which will be described later, steps S81 to S90 are repeated as an example.
  • step S81 the R wave of the leftmost electrocardiographic waveform shown in FIG. 11 is detected.
  • the R wave of the second electrocardiogram waveform from the left is detected in S83, and t 2 -t 1 (seconds) is multiplied by 0.075 to 0.35 from the R wave of the second electrocardiogram waveform from the left in step S86. It is assumed that this is a step relating to the processing after the time delayed, that is, the time u 1 is determined as the output timing of the electric signal.
  • steps S81 to S90 before being repeated are the same as steps S31 to S40 of the above-described embodiment, and thus detailed description thereof is omitted.
  • step S91 if it is not determined in step S90 that the treatment stop signal has not been input, the analysis unit 301 stops the timer 301a. In addition, after the analysis part 301 stops the timer 301a, a process repeats the step after step S81 again.
  • step S81 it is determined whether or not an R wave of the third electrocardiographic waveform from the left is detected.
  • the process of step S81 is performed again. If R-wave of the third electrocardiographic waveform from the left has been detected (step S81 YES), the analysis unit 301 in step S82 to be repeated to start the timer 301a at the time of the count time t 3.
  • step S83 the analysis unit 301 determines whether or not the rightmost electrocardiographic R wave has been detected. If the rightmost electrocardiographic R wave is not detected (NO in step S83), the process of step S83 is performed again. Most if R-wave of the right of the electrocardiographic waveform is detected (step S83 YES), in step S84 to be repeated, the count time t 4 the analysis unit 301 to the R wave of the rightmost electrocardiographic waveform is detected to measure .
  • the period T between the R wave of the third electrocardiogram waveform from the left and the R wave of the rightmost electrocardiogram waveform from the time of the repeated step S82 and the repeated step S84 is t 4 -t 3. is determined as (s) (t 4 of time obtained by subtracting at t 3).
  • step S86 a time obtained by multiplying t 4 -t 3 (seconds) by 0.075 to 0.35 is calculated, and 0 to t 4 -t 3 (seconds) from the R wave of the rightmost electrocardiogram waveform.
  • the analysis unit 301 determines the timing delayed by .075 to 0.35, that is, the time u 2 as the electrical signal output timing.
  • step S87 it is determined whether or not the time delayed from the rightmost R wave of the electrocardiographic waveform by multiplying t 4 -t 3 (seconds) by 0.075 to 0.35, that is, the time of u 2 . Is determined by the analysis unit 301. If it is determined that the time of u 2 has been reached (YES at step S87), the process proceeds to step S88. If it is not determined that the time of u 2 has been reached (NO at step S87), the process proceeds to step S88. The process of S87 is repeated again.
  • step S88 are repeated, the time of the u 2, the trigger signal generation unit 302 a trigger signal for outputting an electrical signal to the electrical stimulator 100 generates and outputs.
  • step S89 it is determined whether or not a treatment stop signal has been input. If it is determined that a treatment stop signal has been input (YES in step S89), the timer 301a is stopped in step S90 and the analysis process is terminated. . If it is not determined that the treatment stop signal has been input (NO in step S89), the process repeats the processes in and after step S91.
  • every other electrical signal is output for each continuous heartbeat (electrocardiographic waveform). For this reason, every other continuous heartbeat (electrocardiographic waveform) can be assisted in blood circulation. Therefore, the burden on the human body P caused by the assistance of blood circulation can be reduced as compared with the electrical stimulation device 100 that continuously outputs the electrical signal for each R wave of the continuous electrocardiogram waveform.
  • Example 1 The electrocardiogram data acquisition apparatus 200 and the electrocardiogram data analysis apparatus 300 were connected.
  • the electrocardiogram data analysis device 300 to which the electrocardiogram data acquisition device 200 is connected and the electrical stimulation device 100 were connected.
  • a detection electrode extending from the electrocardiogram data acquisition apparatus 200 was attached to the subject A's chest.
  • the electrodes provided on the electric stimulator 100 were attached to the left and right ankles of the subject A, respectively.
  • the + electrodes provided on the electrical stimulation device 100 were respectively attached to the lower left (upper knee) of the left and right thighs of the subject A.
  • Electrocardiographic data was obtained from the subject A, and an electric signal that was a pulse wave was output to the lower leg in synchronization with the continuous electrocardiographic waveform.
  • the electrical signal was output at a timing delayed from the R wave by multiplying the latest period T of the R wave by 0.10 and continuously output for each R wave of the continuous electrocardiogram waveform.
  • the output time of the electric signal is set to 0.2 seconds
  • the pulse width of the electric signal is set to 260 ⁇ sec
  • the frequency of the electric signal is set to 20 Hz
  • the current value of the electric signal is the subject A Is set to a current value that is judged to be 4 (slightly tight) on the Borg scale classified into 10 levels.
  • Example 2 Subject A was changed to Subject B. The current value was determined to be 4 (slightly tight) on the Borg scale in which subject B was classified into 10 levels. Other than these conditions, electrical signals were output to the lower leg of subject B under the same conditions as in Example 1.
  • Example 3 Subject A was changed to Subject C.
  • the current value was determined to be 4 (slightly tight) on the Borg scale in which subject C was classified into 10 levels.
  • an electrical signal was output to the lower leg of the subject C under the same conditions as in Example 1.
  • Example 4 Subject A was changed to Subject D. It changed to the electric current value judged that the test subject D was 4 (slightly hard) of the Borg scale classified into 10 steps. Other than these conditions, electrical signals were output to the lower leg of the subject D under the same conditions as in Example 1.
  • Example 5 Subject A was changed to Subject E.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by a time obtained by multiplying the latest period T of the R wave by 0.15. It changed into the electric current value which the test subject E judges as Borg scale 4 (slightly tight) classified into 10 steps.
  • Borg scale 4 lightly tight
  • Example 6 Subject A was changed to Subject F.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by 0.25 multiplied by the period T nearest to the R wave. It changed into the electric current value judged that the test subject F was 4 (slightly hard) of the Borg scale classified into 10 steps. Other than these conditions, electrical signals were output to the lower leg of the subject F under the same conditions as in Example 1.
  • Example 7 Subject A was changed to Subject G.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by 0.075 times the most recent period T of the R wave.
  • the current value was determined to be 4 (slightly tight) on the Borg scale in which subject G was classified into 10 levels.
  • electrical signals were output to the lower leg of the subject G under the same conditions as in Example 1.
  • Example 8 Subject A was changed to Subject H.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by 0.075 times the most recent period T of the R wave. It changed into the electric current value which the test subject H judges as 4 (slightly tight) of the Borg scale classified into 10 steps.
  • an electrical signal was output to the lower leg of the subject H under the same conditions as in Example 1.
  • Example 9 Subject A was changed to Subject I.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by 0.35 multiplied by the latest period T of the R wave.
  • the current value was determined to be 4 (slightly tight) on the Borg scale in which subject I was classified into 10 levels.
  • electrical signals were output to the lower leg of the subject I under the same conditions as in Example 1.
  • Example 10 Subject A was changed to Subject J.
  • the -electrodes provided in the electrical stimulation apparatus 100 were attached to the left and right buttocks and left and right ankles of the subject J, respectively, and the + electrodes were attached to the lower left and right thighs (on the knees) of the subject J, respectively.
  • the output timing of the electrical signal was changed from the R wave to a time delayed by multiplying the latest period T of the R wave by 0.10.
  • the current value was determined so that the subject J was judged to be 4 (slightly tight) on the Borg scale classified into 10 levels.
  • electrical signals were output to the thigh and lower leg of Subject J under the same conditions as in Example 1.
  • Example 11 Subject J was changed to subject K.
  • the output timing of the electrical signal was changed from the R wave to a timing delayed by 0.35 multiplied by the latest period T of the R wave.
  • the current value was determined to be 4 (slightly tight) on the Borg scale in which subject K was classified into 10 levels.
  • electrical signals were output to the thigh and lower leg of subject K under the same conditions as in Example 10.
  • Comparative Example 15 Except for changing the output timing of the electrical signal from the R wave to the time delayed by multiplying the most recent period T of the R wave by 0.30, the same conditions as in Comparative Example 13 were used. An electrical signal was output to the thigh.
  • the blood circulation assistance system 1 of this embodiment in which the output time of the electrical signal is 0.15 to 0.25 seconds is added to the blood circulation assistance effect based on the improvement of the blood pump function of the heart.
  • the blood circulation assisting effect is based on the assistance of the blood pump function, the following examples were carried out.
  • Example 12 Subject A was changed to Subject B.
  • the output timing of the electrical signal was changed from the R wave to a time delayed by multiplying the latest period T of the R wave by 0.30.
  • the current value was determined to be 4 (slightly tight) on the Borg scale in which subject B was classified into 10 levels. Every other R wave of the continuous electrocardiographic waveform detected from the subject B was output as an electrical signal. Other than these conditions, electrical signals were output to the lower leg of subject B for 0.2 seconds under the same conditions as in Example 1.
  • the arterial pressure waveform of the brachial artery was detected using a blood pressure pulse wave inspection apparatus.
  • the doctor confirmed the detected arterial pressure waveform of the subject of Example 12, and evaluated it according to the following evaluation criteria.
  • ⁇ Evaluation criteria> Good In the arterial pressure waveform for at least one heartbeat among the arterial pressure waveforms having the support waveform described above, the diastolic blood pressure is less than the diastolic blood pressure of the arterial pressure waveform corresponding to the electrocardiographic waveform from which no electrical signal is output. It was. Poor: In all the arterial pressure waveforms having the support waveform described above, the diastolic blood pressure was equal to or higher than the diastolic blood pressure of the arterial pressure waveform corresponding to the electrocardiographic waveform from which no electrical signal was output.
  • Table 2 shows the output conditions of the output electrical signal and the result of evaluation 2 for Example 12.
  • the evaluation result of Evaluation 2 was “Good”. From this result, the blood circulation assistance system 1 of Example 12 in which the output time of the electric signal is within the range of 0.15 seconds to 0.25 seconds is added to the blood circulation assistance effect based on the improvement of the blood pump function of the heart. Thus, it can be understood that the blood circulation assisting effect is based on assisting the blood pump function of the heart.

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PCT/JP2016/079325 2015-10-07 2016-10-03 心拍同期型の血液循環補助システム、制御方法及び心拍同期型の電気刺激装置 WO2017061386A1 (ja)

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EP0847776A1 (de) * 1996-12-11 1998-06-17 Bavaria Patente und Lizenzen Verwertungsgesellschaft mbH Vorrichtung zum Stimulieren eines Muskels oder von Muskelgruppen
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