KR101809635B1 - Heartbeat synchronous blood circulation assisting system, control method and heartbeat synchronous electrical stimulating device - Google Patents

Abstract

The present invention relates to a blood circulatory assist system, which is difficult to cause complications, and which does not adversely affect the self-tune cardiac contractile function, a control method thereof, and an electric stimulation apparatus.
An electric stimulation apparatus (100) for outputting a pulsed electric signal to at least a lower part of a human body (P), an electrocardiograph data acquisition device (200) for continuously acquiring an electrocardiogram waveform from the human body (P) And an ECG data analyzing device (300) for analyzing the ECG waveform acquired by the ECG device (200) and determining the output timing of the electric signal output from the electric stimulation device (100), wherein the ECG data analyzing device , A timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform is determined as the output timing, and 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.

Description

Technical Field [0001] The present invention relates to a pacemaker-type blood circulation assist system, a control method, and a pacemaker type electric stimulator,

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood circulatory assist system, an electric stimulation apparatus, and a blood circulation assist system for assisting blood circulation.

Heart-assisted circulation therapy is a treatment for the conditions causing abnormalities in blood circulation such as heart failure. Cardiac assisted circulation therapy is a method of improving blood circulation by physiological / physiological approach and improving the condition of the bed. Intraortic balloon pumping (IABP method) or augmented extermination counter discharge method (EECP method) has been performed as a cardiac assisted circulation therapy in Japan and abroad.

In the intra-aortic balloon pumping method, a balloon held in the descending aorta is expanded and contracted in accordance with the heartbeat. When the balloon is expanded within the descending aorta at the diastole of the heart, the blood flow to the coronary artery, which is the nutrient vessel of the heart, increases. When a balloon that has expanded in the systole of the heart contracts, the pressure in the artery drops. By inflating and deflating the balloon at such a timing, the heart is easy to push out the blood, and blood circulation is assisted.

In addition, the augmented exter- sion type counterpulsation method expands and contracts the pants-type balloon covering the lower limb in accordance with the heartbeat of the heart, thereby pressing the artery of the lower limb or releasing the pressure of the artery of the lower limb. At the time of pant swelling, blood flow to the coronary artery, which is the nutrition blood vessel of the heart, increases. When the pants is contracted, the compression of the artery of the lower limb is released, and the pressure in the artery is lowered. Thus, by expanding and contracting the pants-type pullover, the heart is easy to push out the blood, and it is possible to assist the blood circulation in the same manner as the intra-aortic balloon pumping method.

In the intra-aortic balloon pumping method, an insertion port for inserting a balloon is opened in the brachial artery or the femoral artery in order to hold the balloon in the descending aorta. In other words, balloon pumping in the aorta is an invasive treatment method, and the invasion of the patient is high. While the balloon is in the blood vessel, the blood coagulant must be continuously administered, which increases the risk of complications. Since it is open-circuited, there is also a problem that it is easy to cause complications such as infection.

In addition, in the enhancer type external counterpulsation method, by continuously shrinking and expanding the pant-type balloon for a predetermined period of time, a strong strong stimulus is continuously applied to the skin surface of the lower limb. Therefore, there is a problem that complications such as erosion or ulceration of the skin are likely to occur.

The present invention has been made in view of such circumstances. It is possible to provide a blood circulatory assist system and an electric stimulating device which are difficult to cause complications which are problematic in the conventional system as described above and which do not adversely affect the self-tuneable cardiac contraction expanding function, And an object of the present invention is to provide a control method of a blood circulatory assist system capable of maintaining an optimal state of timing.

(1) In order to solve the above-mentioned problems, the human blood circulation assist system according to the present invention includes an 'electric stimulation device' for outputting a pulse-shaped electric signal to at least a lower part of the human body, And an electrocardiograph data analyzing device for analyzing the electrocardiographic waveform acquired by the electrocardiograph data acquiring device and for determining an output timing of the electric signal output from the electric stimulating device. The electrocardiogram data analyzing device determines a timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform as the output timing. And 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.

(2) In the configuration of (1), the period T may be a recent period of the R wave.

(3) In the configuration of (1) or (2), the electrocardiogram data analyzing device may determine the output timing each time the R wave is detected.

(4) In the configuration of (1) or (2), the electrocardiogram data analyzing apparatus may further include: processing for determining the output timing when the R wave is detected; It is possible to alternately repeat processing that is not performed.

(5) In the above-mentioned constitution (1) to (4), the electric stimulation apparatus may further output the electric signal to the femoral region of the human body.

(6) In any one of (1) to (5), the output time of the electric signal within the period T may be 0.15 to 0.25 seconds.

(7) Further, a method of controlling a blood circulatory assist system that outputs an electric pulse-shaped electric signal to at least a lower part of a human body according to the present invention to thereby provide an electric stimulus to the human body to assist blood circulation, And determines the timing at which the electric wave signal is delayed by a predetermined time from the R wave included in the electrocardiogram waveform as the output timing of the electric signal, T is multiplied by 0.075 to 0.35.

(8) The electric stimulating apparatus for imparting electric stimulation to a human body according to the present invention comprises: an electric signal output unit for outputting an electric signal composed of a pulse wave in synchronization with an electrocardiographic waveform detected from the human body; Wherein the electric signal output unit outputs the electric signal at an output timing delayed by a predetermined time from an R wave included in the electrocardiogram waveform, Time period T is multiplied by 0.075 to 0.35.

According to the present invention, it is possible to provide a blood circulatory assist system and an electric stimulation device which are less likely to cause complications that are often recognized in existing systems as described above, and which do not adversely affect the self-tuneable cardiac contraction and expansion function. In addition, according to the present invention, it is possible to provide a blood circulation assist system control method capable of maintaining the output timing of an electric signal of the blood circulatory assist system in an optimal state.

1 is a functional block diagram of a blood circulatory assist system.
Fig. 2 is a flowchart showing the sequence of processing performed by the electrocardiogram data analyzing apparatus. Fig.
3 is a timing chart corresponding to the flow chart of Fig.
4 is a diagram showing a configuration of an electric stimulation apparatus.
5 is a diagram showing a processing flow of the blood circulatory assist system.
6 is a diagram showing an arterial pressure waveform of the brachial artery of the human body P in which an electric signal is continuously output for each R wave of continuous electrocardiographic waveforms.
Fig. 7 is a diagram showing arterial pressure waveforms of the brachial artery of the human body P outputting one all-electric signal for each R wave of continuous electrocardiographic waveforms.
8 is a flowchart showing a procedure of processing performed by the electrocardiogram data analyzing apparatus according to the first modification.
9 is a timing chart corresponding to the flow chart of Fig.
10 is a flowchart showing a procedure of processing performed by the electrocardiogram data analyzing apparatus according to the second modification.
11 is a timing chart corresponding to the flow chart of Fig.

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, embodiments of the present invention will be described with reference to the drawings. Fig. 1 is a functional block diagram of the blood circulatory assist system 1 of the present embodiment, and arrows in dotted lines indicate transmission directions of signals and the like. The blood circulatory assist system 1 of the present embodiment includes an electric stimulation apparatus 100 for outputting an electric signal for imparting an electric stimulus to at least a lower half portion of the human body P and an electric stimulation apparatus 100 for outputting a continuous electrocardiogram waveform from the human body P And an output timing of the electric signal is calculated by calculating a time obtained by multiplying the cycle T, which is the period of the R wave included in the electrocardiographic waveform, by 0.075 to 0.35, and the electric stimulation apparatus 100) for outputting a trigger signal for operating the electrocardiogram data analyzing apparatus (300).

First, the electrocardiograph data acquisition device 200 will be described. The electromyogram data acquisition device 200 has a electromyogram data acquisition section 201 as shown in FIG. The ECG data acquisition section 201 acquires ECG data including continuous ECG waveforms from detection electrodes (not shown) fixed to the body surface of the human body P (that is, continuously acquires ECG waveforms). . Further, the ephemeris data acquisition unit 201 outputs the acquired ephemeris data to the ephemeris data analysis apparatus 300. [ The electrocardiograph data acquisition device 200 can be configured by, for example, an electrocardiograph. On the other hand, the acquisition of the electrocardiographic data and the output of the electrocardiogram data can be performed by the wireless communication means and / or the wired communication means.

Next, the electrocardiographic data analyzing apparatus 300 will be described. As shown in Fig. 1, the electrocardiographic data analyzing apparatus 300 has an analyzing section 301 and a trigger signal generating section 302. [

The analyzing unit 301 includes a timer 301a. However, the timer 301a may be provided outside the analyzing section 301. [ The analyzing unit 301 analyzes the ECG data output from the ECG data obtaining unit 201 and determines the output timing of the electrical signal based on the counter result of the timer 301a. The analyzing unit 301 also transmits the information including the determined output timing to the trigger signal generating unit 302. [

The trigger signal generating unit 302 generates a trigger signal for outputting an electric signal to the electric stimulation apparatus 100 at the output timing transmitted from the analyzing unit 301. [ The trigger signal generating unit 302 outputs the generated trigger signal to the electric stimulation apparatus 100. [

On the other hand, the acquisition of the ECG data output from the ECG data acquisition section 201 and the output of the trigger signal generated by the trigger signal generation section 302 can be performed by the radio communication means and / or the wired communication means.

Next, the processing performed by the electrocardiogram data analysis apparatus 300 will be described in detail with reference to Figs. 2 and 3. Fig. Fig. 2 is a flowchart showing the sequence of processes performed by the electrocardiogram data analyzing apparatus 300. Fig. Fig. 3 is a timing chart corresponding to the flow chart of Fig. 2. The upper timing chart schematically shows the electrocardiographic waveform detected from the human body P, and the lower timing chart shows the waveform of the electrical signal output in synchronization with the electrocardiographic waveform As shown in FIG.

In step S31, the analyzer 301 analyzes the electrocardiographic data output from the electrocardiac data acquisition unit 201, and determines whether or not the R wave included in the electrocardiographic waveform is detected. Here, if the R wave is detected (YES in step S31), the process proceeds to step S32, and if the R wave is not detected (NO in step S31), the process in step S31 is repeated again. On the other hand, R-wave is a waveform that appears when the ventricle contracts. As shown in Fig. 3, the R wave has a larger amplitude (in other words, the voltage (potential) is larger than the P wave, Q wave, S wave and T wave included in the electrocardiographic waveform).

In step S32, the analyzer 301 starts the timer 301a, and the process proceeds to step S33. For example, if the R wave of the electrocardiogram waveform four electrocardiogram waveforms on the left of the shown in Figure 3 is detected at step S31, thereby starting a timer (301a) according to the count time t ₁ at step S32.

In step S33, the analyzer 301 determines whether or not the next R wave is detected. For example, when the R wave of the leftmost electrocardiographic waveform is detected in step S31, it is determined in step S33 whether or not the next R wave, that is, the R wave of the second electrocardiographic waveform from the left is detected. If the next R wave is detected (YES in step S33), the process proceeds to step S34, and if the next R wave is not detected (NO in step S33), the process in step S33 is repeated again.

In step S34, the analyzing unit 301 measures the count time when the next R wave is detected in step S33. For example, when the R-wave of the electrocardiogram waveform of the second from the left in step S33 is detected, in step S34 t ₂ is measured as the count time.

In step S35, the analyzer 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 (seconds) of the R wave. For example, if the step S32 and the count time of the step S34 in each of t ₁ and t _2, is determined as a (time, remove the t ₂ to t ₁₎ t ₂ -t ₁ the period T.

In step S36, the analyzing section 301 calculates the time obtained by multiplying the period T determined in step S35 by 0.075 to 0.35, and outputs the timing delayed by multiplying the period T by 0.075 to 0.35 from the time when the R wave is detected to the output The analyzing unit 301 determines the timing. For example, when an R wave of the leftmost electrocardiographic waveform is detected in step S31 and an R wave of a second electrocardiographic waveform from the left is detected in step S33, the R wave of the second electro- A timing delayed by multiplying the period T (T = t ₂ -t ₁ ), which is the latest period of the wave, by 0.075 to 0.35, that is, the count time u ₁ , is determined as the output timing. On the other hand, the value multiplied by the period T can be appropriately adjusted within 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 electric stimulation apparatus 100 Can be set.

In step S37, the analyzing unit 301 determines whether or not the output timing determined in step S36 is reached from the time of the timer 301a. For example, if the most recent cycle time multiplied by the delayed timing of 0.075 ~ 0.35 to t ₂ -t ₁ of the R wave than the R wave of the electrocardiogram waveform of the second from the left in step S36 is determined as the output timing, of u ₁ It is determined whether or not it is time. Here, if it is determined that the output timing is reached (YES in step S37), the process proceeds to step S38, and if it is not determined that the output timing is reached (NO in step S37), the process in step S37 is repeated again.

In step S38, the trigger signal generator 302 generates a trigger signal for outputting the electric signal to the electric stimulator 100 at the output timing of the electric signal determined in step S37, and outputs the trigger signal to the electric stimulator 100 do. In this case, an electric signal is immediately output from the electric signal output unit 101 that has received the trigger signal.

In step S39, the analyzing unit 301 determines whether or not the treatment stop signal is inputted. If it is determined that the treatment stop signal is input (YES in step S39), the timer 301a is stopped in step S40 and the analysis process is terminated. Here, the analyzing unit 301 may be configured so that the treatment stop switch provided in the electric stimulation apparatus 100 is depressed, or the electrocardiogram data acquiring apparatus 200, the electrocardiogram data analyzing apparatus 300, and the electric stimulation apparatus 100 is turned OFF, it can be determined that the treatment stop signal is inputted.

When the treatment stop signal is not inputted (NO in step S39), the process returns to step S33 to determine the time u ₂ , u _3, ..., The electric stimulation synchronized with the electrocardiographic waveform is performed.

On the other hand, in the present embodiment, although the period T is determined from two consecutive electrocardiographic waveforms, an average value of the period T (seconds) may be calculated from three or more continuous electrocardiographic waveforms, and this may be determined as the period T. The trigger signal may include information on the output timing. In this case, the trigger signal generator 302 immediately outputs the generated trigger signal to the electric stimulator 100, and the electric signal output unit 101 outputs the electric signal until the output timing included in the trigger signal I never do that.

Next, the electric stimulation apparatus 100 will be described with reference to FIG. The electric stimulation apparatus 100 includes an electric signal output section 101 and an electrode 102. The electric signal output section 101 outputs an electric signal based on the trigger signal output from the trigger signal generating section 302. [ The electrode 102 transmits the electric signal output by the electric signal output section 101 to the human body P. [

The electric stimulation apparatus 100 further includes a storage unit 13, an operation unit 14, a power source unit 15, and a display unit 16. The storage unit 13 stores the frequency, the pulse width, the output time, the current value, and the output pattern of the electric signal output from the electric signal output unit 101 (an electric signal continuously for each R wave of the continuous electro- Whether or not to output it), and the like. The operation unit 14 includes an operation switch for switching on and off of the electric stimulation apparatus 100, and a setting button for setting the energization mode. The power supply unit 15 supplies electric power to the respective components of the electric stimulation apparatus 100. The display unit 16 can display information such as the energization method.

Next, the configuration of the electric signal output section 101 will be described in detail. The electric signal output section 101 is provided with an output control section 12 for controlling the output timing and the energization state of the electric signal and an output port 11 for generating and outputting an electric signal based on the control by the output control section 12 ).

The output control unit 12 includes a microcomputer. The output control section 12 controls the energization state of the electric signal generated and output by the output port 11 based on a signal output from the operation section 14 or the like. The output control unit 12 also controls the output timing of the electric signal based on the trigger signal input from the electrocardiogram data analyzing apparatus 300 (trigger signal generating unit 302). When the trigger signal does not include information on the output timing, the output control section 12 generates and outputs an electric signal to the output port 11 while the trigger signal is input. When the trigger signal includes information on the output timing, the output control section 12 generates and outputs an electric signal to the output port 11 after the output timing.

The electric signal output section 101 (output port 11) outputs an electric signal which is a pulse-shaped waveform. The output time of the electric signal may be less than the time multiplied by 0.65 in the period T, and may be suitably set 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 may be, for example, 200 mu sec to 300 mu sec. The current value of the electric signal transmitted to the lower leg portion can not be uniquely determined because it is influenced by the amount of muscle or the like, but may be 20 mA to 30 mA as an example. The frequency of the electric signal can be suitably set by those skilled in the art, and is preferably 20 Hz to 30 Hz, for example. An electric signal with a frequency of 20 Hz or more tends to constrict the artery continuously, and a pulse wave having a frequency of 30 Hz or less is likely to respond to the motor nerve and easily contract muscles.

Next, the electrode 102 will be described. The electrode 102 is provided with a right electrode portion 60 mounted on the right side of the human body P and a left electrode portion 61 mounted on the left side of the human body P as shown in Fig. At least two positive electrodes including a positive electrode and a negative electrode are provided in the electrode portions 60 and 61. These two positive electrodes can be respectively mounted on the ankles and lower legs of the human body P (above the knee). Specifically, the positive electrode and the negative electrode of the right electrode unit 60 are respectively attached to the right lower thigh and the right ank of the human body P, and the + electrode and the - The lower left thigh and the left ank of the human body P, respectively. When the electrode 102 is attached to the above-described portion, the electric signal is transmitted to a portion from the ankle of the human body P to the lower portion of the thigh, that is, at least the lower portion of the human body P. The constitution and the mounting method of the electrode 102 are not limited to the configuration and the mounting method as long as the electric signal can be transmitted to at least the lower part of the human body P. [ For example, positive and negative electrodes of the electrode portions 60 and 61 may be mounted on ankles and knees, respectively.

The electrode 102 may be configured to transmit an electric signal to the femoral portion of the human body P in addition to the hip portion of the human body P. [ When the electrode 102 is configured as described above, for example, the electrode portions 60 and 61 may be configured to include at least three positive electrodes that are respectively mounted on the ankle, the thigh, and the waist portion. These three positive electrodes are configured to include at least a positive electrode and a negative electrode, and the polarities of the positive and negative electrodes mounted on the ankle and the waist are different from those of the positive electrode mounted on the thigh. When a positive electrode is attached to the right thigh with respect to the positive electrode of the right electrode unit 60, a negative electrode is attached to the right waist and the right ankle of the human body P, respectively. When the positive electrode is attached to the left thigh of the human body P with respect to the positive electrode of the left electrode portion 61, the negative electrode is attached to the left waist and the right ankle. When the electrode 102 is constructed as described above, the electric signal is transmitted to the region from the ankle to the waist of the human body P, that is, at least the lower portion and the thigh portion of the human body P. [ On the other hand, the constitution and the mounting method of the electrode 102 are not limited to the constitution and the mounting method thereof, as long as they can transmit an electric signal to the hip portion and the thigh portion of the human body P. For example, an electrode may be attached to the knee with respect to the positive electrode of the electrode unit 60, 61, and a + electrode may be attached to the waist and ankle, respectively.

Herein, the lower leg refers to a portion from the knee to the ankle of the human body P, and the femoral portion refers to a portion up to the groin (inguinal part) of the human body P above the knee of the human body P. On the other hand, the current value of the electric signal transmitted to the femoral region can not be determined uniquely because it is influenced by the muscle amount and the like, but it can be set to 25 mA to 35 mA, for example.

The positive electrode of each of the electrode units 60 and 61 may be covered with a non-conductive member, and a conductive member may be provided only on the contact surface with the human body P. The positive electrode of each of the electrode portions 60 and 61 may have a band-like configuration so as to be wound around the human body P. On the other hand, the number, the size and the shape of the positive electrodes of the electrode portions 60 and 61 can be changed according to the attachment site and the body shape of the human body P.

Next, the processing flow of the entire blood circulatory assist system 1 of the present embodiment will be described. 5 is a diagram showing a processing flow of the blood circulatory assist system 1. Fig. First, in step S71, an electrocardiographic waveform is continuously detected from the human body P. Next, in step S72, the electrocardiographic waveform detected in step S71 is analyzed, and the time obtained by multiplying the period T, which is the period of the R wave, by 0.075 to 0.35 is calculated. Next, in step S73, the timing delayed from the R wave calculated in step S72 is determined as the output timing of the electric signal. Next, in step S74, an electric signal is outputted at the output timing determined in step S73.

5 is performed by the electrocardiographic data acquisition device 200, the electrocardiogram data analysis device 300 and the electric stimulation device 100 in the blood circulatory assist system 1 of the present embodiment, The entire electric stimulation apparatus 100 may be configured to perform the entire operation.

Here, in the blood circulatory assist system 1 of the present embodiment, the electric signal is outputted at the output timing delayed by 0.075 to 0.35 times the cycle T from the R wave included in the electrocardiographic waveform. The electric signal outputted at this timing is transmitted to the lower leg portion, causing muscle contraction of the lower leg portion at a predetermined timing in the diastole of the heart (muscular pump action). The artery of the lower leg is pressed by the muscular contraction of the lower leg caused at this predetermined timing, and at the time when arterial blood is likely to flow into the coronary artery, which is the nutritional blood vessel of the heart, the arterial blood of the lower leg is directed toward the heart (left ventricle) Pushing action occurs. Because of this, the arterial blood pushed back toward the heart (left ventricle) is likely to flow into the coronary artery, thereby improving the blood pump function of the heart. Therefore, according to the blood circulatory assist system 1 of the present embodiment, the heart is easy to send out blood, and it is possible to assist circulation of blood flowing through the human body P. In addition, since the above-described blood-circulation-assisting effect is based on improvement of the blood pump function of the heart, it does not interfere with the circulation (reflux) of blood and adversely affects self-tuning expansion of the cardiac contraction.

On the other hand, when the electric signal outputted from the blood circulatory assist system 1 is outputted at an output timing earlier than the time obtained by multiplying the cycle T by 0.075 than the R wave, or when the output timing is slower than the time obtained by multiplying the cycle T by 0.35 The arterial blood of the lower leg becomes less likely to be pushed back toward the heart (left ventricle) at the timing when arterial blood is likely to flow into the coronary artery. As a result, the blood pump function of the heart is hardly improved, and the circulation of the blood flowing through the human body P can not be assisted. In the electrical signal output at these output timings, the timing at which the arterial blood of the lower leg is pushed back toward the heart (left ventricle) is not synchronized with the timing at which the arterial blood is likely to flow into the coronary artery. It becomes easy to go crazy. In addition, even when the output timing of the electric signal output from the blood circulation assistant system 1 is delayed by 0.075 to 0.35 times the cycle T from the R wave, if no electric signal is output to the hypothetical part, It can not assist blood circulation without adversely affecting the expansion and contraction function.

Whether or not blood circulation assist based on the improvement of the blood pump function of the heart is possible can be appropriately determined by those skilled in the art on the basis of the technical knowledge and can be appropriately determined based on the intra-aortic balloon pumping method (IABP method) or the intracoronary counter- EECP method) and the like can be referred to. For example, a method of confirming the arterial pressure waveform of the brachial artery detected from the human body P from which the electric signal is outputted may be used. 6 is a graph showing arterial pressure waveforms of the brachial artery of the human body P outputting the electric signals continuously with respect to each of the R waves of the continuous electrocardiographic waveform, wherein the abscissa is time (second) and the ordinate is pressure (mmHg )to be. As shown in the arterial pressure waveforms of Figs. 6A and 6B, in the arterial waveform W1 of at least one heartbeat among the arterial pressure waveforms detected from the human body P from which the electric signal is outputted, the support waveform W10 ), It can be judged that blood circulation assistance based on improvement of the blood pump function of the heart is possible. On the other hand, as shown in the arterial pressure waveform in Fig. 6C, when the support waveform W10 can not be confirmed in the detected arterial pressure waveform W2, the blood circulation based on the improvement of the blood pump function of the heart It can be judged that assistance is not possible.

The support waveform W10 is a signal obtained from the human body P and can not be determined uniquely because there is a difference between individuals. However, as an example, as shown in the arterial pressure waveforms in Figs. 6A and 6B, The blood pressure rises sharply from the time of the aortic occlusion T11 to reach the agitation pressure P11 and the blood pressure falls from the time T12 of measurement of the agitation pressure P11 to the end of the divergence T13, And a waveform reaching the blood pressure P12. On the other hand, the agitation pressure P11 is preferably higher than the systolic blood pressure P10 as shown in Fig. 6 (a).

In this specification, the term "systole" refers to a period from the time of the opening of the aortic valve (T10) (T20) to the time of the occlusion of the aortic valve (T11) (T21) (T13) (T23) at the next aortic opening. When the aortic cross-over opening time T10 (T20) indicates the diastolic blood pressure P12 (P22) is measured, the next aortic opening time T13 (T23) indicates the diastolic blood pressure P12 Of the diastolic blood pressure P12 (P22) after the diastolic blood pressure P12 is measured. Further, the aortic occlusion time T11 (T12) represents the time when the dicrotic notch (D) (D ') is measured.

As described above, the conventional intra-aortic balloon pumping method and the augmented external-body counter-pulse method that assist in the circulation of blood are problematic in that complications such as infectious diseases are liable to occur due to high invasiveness, There was a problem that it was easy to cause complications. However, according to the blood circulatory assist system 1 of the present embodiment, the blood circulation can be assisted only by outputting an electric signal to the lower leg portion at a predetermined timing, so that the treatment can be performed non-openly, (P). Therefore, it is difficult to cause complications such as infection or ulcer.

In the blood circulatory assist system 1 of the present embodiment, the output time of the electric signal within the cycle T is preferably 0.15 second to 0.25 second. In the blood circulatory assist system 1 of the present embodiment, when the output of the electric signal outputted to the lower leg portion is stopped, the pressure of the artery of the lower leg is released, and the resistance in the artery is lowered (pressure in the artery is lowered) When the output time of the electric signal is 0.15 second to 0.25 second, the resistance in the artery (pressure in the artery) tends to lower at the systole of the heart. As a result, the heart is liable to cause the blood in the heart (left ventricle) to flow out into the artery (as if the blood in the heart (left ventricle) is drawn into the arterial blood vessel) It becomes easy (lower self-systolic blood pressure). That is, the blood pump function of the heart is assisted. Therefore, in the blood circulatory assist system 1 of the present embodiment, when the output time of the electric signal is 0.15 second to 0.25 second, in addition to the improvement of the blood pump function of the heart described above, Thereby helping the blood circulation. On the other hand, the blood circulation assist effect obtained by setting the output time of the electric signal in the range of 0.15 to 0.25 seconds is based on the improvement of the blood pump function of the heart and the assistance, so that the blood circulation (reflux) It is difficult to adversely affect the function of expanding the cardiac contraction.

On the other hand, when the output time of the electric signal is out of the range of 0.15 to 0.25 seconds, the resistance in the artery (pressure in the artery) is hardly lowered in the systole of the heart. As a result, the load on the heart is less likely to be relieved, and the blood circulation assist effect based on the assistance of the blood pump function of the heart is hardly obtained. Further, in an electric signal whose output time is out of the range of 0.15 to 0.25 seconds, the decrease in the resistance in the artery (the pressure in the artery) becomes difficult to synchronize with the systolic period of the heart, so that the self- .

Whether or not the blood circulation support effect based on the assist of the blood pump function of the heart is obtained in addition to the blood circulation assist effect based on the improvement of the blood pump function of the heart described above can be determined by a person skilled in the art . For example, it may be a method of confirming the arterial pressure waveform of the brachial artery of the human body P outputting one electrical signal for each R wave of continuous electrocardiographic waveforms.

Fig. 7 is a diagram showing arterial pressure waveforms of the brachial artery of the human body P outputting one all-electric signal for each R wave of continuous electrocardiographic waveforms. The arterial pressure waveform W3 (W4) shown in Fig. 7 represents an arterial pressure waveform corresponding to an electrocardiographic waveform to which an electric signal is output, and has a support waveform W30 (W40). The arterial pressure waveforms W3 'and W4' shown in Fig. 7 show an arterial pressure waveform corresponding to an electrocardiographic waveform to which no electric signal is output. As shown in Fig. 7A, in the arterial pressure waveform W3 of at least one heartbeat among the arterial pressure waveforms having the support waveform W30, the diastolic blood pressure P31 corresponds to the electrocardiographic waveform in which no electric signal is outputted (P30) of the arterial pressure waveform W3 'of the arterial pressure waveform W3', it is possible to provide a blood circulatory assist effect based on the improvement of the blood pump function of the heart, Can be obtained. On the other hand, as shown in Fig. 7 (b), in all the artery pressure waveform W4 having the support waveform W40, the diastolic blood pressure P41 is the arterial pressure waveform corresponding to the electrocardiographic waveform W4 '), it can be judged that the blood circulation assist effect based on the assist of the blood pump function of the heart is not obtained.

On the other hand, whether or not the blood circulation assist effect based on the improvement of the blood pump function of the heart has a blood circulation assist effect based on the assistance of the blood pump function of the heart is not limited to the above-mentioned method, It can be judged by confirming the arterial pressure waveform of the brachial artery of the human body P outputting an electric signal continuously for each R wave of the waveform. Specifically, the diastolic blood pressure of the human body P when no electric signal is output is detected, and this diastolic blood pressure is set as the reference diastolic blood pressure. It is also possible to detect the arterial pressure waveform of the human body P when successive electric waves are outputted to each of the R waves of the continuous electrocardiogram waveform and to detect the arterial pressure waveform of the arterial pressure waveform having the support waveform To the target diastolic blood pressure. When the subject diastolic blood pressure is lower than the reference diastolic blood pressure, in addition to the blood circulation assist effect based on the improvement of the blood pump function of the heart, the blood pump function of the heart It can be judged that the blood circulation assist effect based on the assist of the blood circulation is obtained. On the other hand, when the subject diastolic blood pressure is equal to or greater than the reference diastolic blood pressure, it can be judged that the blood circulation assist effect based on the assistance of the blood pump function of the heart is not obtained.

Further, by configuring the blood circulatory assist system 1 of this embodiment to output an electric signal at an output timing delayed from the R wave by 0.075 to 0.35 times the latest cycle T of the R wave, the latest cycle T And outputs the electric signal to the output timing determined based on the output timing. Therefore, even when the heart is beating irregularly, the output electric signal can be accurately synchronized with the heartbeat (electrocardiographic waveform).

Further, since the electrocardiogram data analyzing apparatus 300 is configured to determine the output timing each time the R wave is detected, an electric signal is output every time the heart is beat (every time the electrocardiographic waveform is mixed) You can assist your blood circulation every time you beat. Then, the ejection amount of the heart may be continuously increased.

Compared with the case where the output time of the electric signal is out of the range of 0.15 second to 0.25 second when the output time of the electric signal outputted from the electric stimulation apparatus 100 is set to 0.15 second to 0.25 second corresponding to each output timing , The arteries can be reliably pressed. Therefore, when the output time of the electric signal is set to 0.15 seconds to 0.25 seconds, blood circulation can reliably assist. Further, the ejection amount of the heart may be further increased. When the output time of the electric signal outputted from the electric stimulation apparatus 100 is set to 0.15 second to 0.25 second, an electric signal is likely to be outputted at the output timing determined by the electric field data acquisition apparatus 300. When the output time of the electric signal is less than 0.15 second, since the contraction time of the muscle is short as compared with the case where the output time is 0.15 seconds or more, sufficient muscle tension may not be obtained enough to press the artery. In such a case, the artery becomes difficult to be pressed. In addition, when the output time of the electric signal exceeds 0.25 seconds, the electric signal may not be output at the output timing determined by the electric / optical system data acquisition device 300, as compared with the case where the output time is 0.25 seconds or less. For example, if the output time of the electric signal is longer than 0.25 seconds because the period T is short, a person who has an excessively high heart rate than a normal heart rate (for example, 50 to 90 times / minute) The output timing of the new electric signal may be immediately obtained at the end of the output. In such a case, it may be difficult for an electric signal to be outputted at a determined output timing.

Further, the electric stimulation apparatus 100 is configured to output an electric signal to the femoral portion of the human body P in addition to the hip portion, thereby pressing the artery of the lower leg and the thigh. In other words, as compared with the blood circulatory assist system 1 in which an electric signal is outputted only to the lower leg portion, many arteries can be pressed, and thus blood circulation can be further assisted. Further, the ejection amount of the heart may be further increased.

On the other hand, according to the method of controlling the blood circulatory assist system 1 of the present embodiment, as described above, the output timing of the electric signal of the blood circulatory assist system can be maintained in an optimum state.

(Modified Example 1)

Next, a variation 1 of the blood circulatory assist system 1 of the present embodiment will be described with reference to Figs. 8 and 9. Fig. In the embodiment described above, the timing delayed by multiplying the latest period T of the R wave by 0.075 to 0.35 with respect to the process performed by the electrocardiogram data analyzing apparatus 300 is determined as the output timing of the electric signal. However, The output timing of the signal may be a timing delayed by 0.075 to 0.35 times the period T of the R wave from the R wave. That is, the timing may be delayed from the R wave by 0.075 to 0.35 times the cycle T, which is not the latest cycle of the R wave. In the first modified example, the output timing of the electric signal is determined as the output timing described above. Even with such an output timing, blood circulation can be assisted without adversely affecting the self-tuneable cardiac contraction expanding function.

On the other hand, in the following steps S46 to S55, as an example, the R wave of the leftmost electrocardiographic waveform among the electrocardiographic waveforms shown in Fig. 9 is detected in step S41, and the R wave the detection is, assumed to be associated with the processing after the period determined as t ₂ -t ₁ (sec) in step S45 t step. Since steps S41 to S45 are the same as steps S31 to S35 of the above-described embodiment, detailed description thereof will be omitted.

In step S46, it calculates the analysis time multiplied by 0.075 ~ 0.35 to t ₂ -t ₁ (s) determined in step S45 (301). In Modification 1 of this embodiment, unlike the above-described embodiment, the process of calculating the time obtained by multiplying the cycle T by 0.075 to 0.35 and the process of determining the output timing of the electric signal are performed.

In step S47, the analyzing unit 301 determines whether or not an R wave of the third electrocardiographic waveform from the left is detected. When an R wave of the third electrocardiographic waveform from the left is detected (YES in step S47), the process proceeds to step S48. If no R wave of the third electro-optic waveform from the left is detected (NO in step S47), step S47 is repeated again.

Next, in step S48, the time obtained by multiplying the 0.075 ~ 0.35 to R wave t ₂ -t ₁ (sec.) From the third electrocardiogram waveform at the left side of the delayed timing, that is, the analysis unit of time u ₁ as the output timing of the electrical signal (301).

In step S49, the analyzing section 301 measures the count time t ₃ at which the R wave of the third electrocardiographic waveform from the left is detected.

In step S50, the analysis step S44 and the period (t ₃ -t ₂₎ of the R-wave of the step S49 from the hour, and the third waveform in the electrocardiogram R wave and the left side of the third electrocardiogram waveform at the left side of the (second) section (301 ).

Next, in step S51, the analysis time multiplied by 0.075 ~ 0.35 in the t ₃ -t ₂ (s) 301 is calculated.

In step S52, it is determined the analysis unit 301 whether or not the output timing (time of u ₁₎ determined in step S48. Here, if it is discriminated that the time of u ₁ (step S52 YES), the process if it is not determined and the process proceeds to step S53, that the time of u ₁ (step S52 NO), the re-processing of the step S52 Repeat.

In step S53, the trigger signal generation unit 302 generates a trigger signal at the time of u ₁ , and outputs a trigger signal to the electric stimulation apparatus 100.

Next, in step S54, it is determined whether or not a treatment stop signal is 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 and the analysis process is terminated . If it is determined in step S54 that the treatment stop signal is not inputted (NO in step S54), the process returns to step S47, and the subsequent steps are repeated. On the other hand, in the step S48 is repeated in the following, is obtained by multiplying the time-delayed timing of 0.075 ~ 0.35 to R wave t ₃ -t ₂ (second) from the electrocardiogram waveforms on the right, that is the time of u ₂ is determined as the output timing of the electrical signal .

(Modified example 2)

Next, a second modification of the blood circulatory assist system 1 of the present embodiment will be described with reference to Figs. 10 and 11. Fig. In the above-described embodiment, regarding the process performed by the electrocardiogram data analyzing apparatus 300, the output timings are determined so that the electric signals are continuously output for each of the R waves of the continuous EC waves (that is, The output timing is determined every detection). In this modification, the output timing is determined so that the electric signals are output one by one for each of the R waves of the continuous electrocardiographic waveform (i.e., the R wave is detected The process of determining the output timing and the process of not determining the output timing even if the R wave is detected) are alternately repeated. Even when an electric signal is output at such an output timing, blood circulation can be assisted without adversely affecting the self-tuning cardiac contraction expanding function.

On the other hand, in steps S81 to S90, which are successively repeated in steps S91 and S91 described below, the R wave of the leftmost electrocardiographic waveform among the electrocardiographic waveforms shown in FIG. 11 is detected in step S81, 2, and the R wave of the electrocardiogram waveform of the second detected from the left, the delay time multiplied by 0.075 ~ 0.35 to R wave t ₂ -t ₁ (second) from the second electrocardiogram wave from the left in step S86 timing, that is, the u ₁ It is assumed that the time is a step related to the process after the time is determined as the output timing of the electric signal. Steps S81 to S90 before repeating are the same as steps S31 to S40 in the above-described embodiment, respectively, and therefore, detailed description thereof will be omitted.

In step S91, when it is determined in step S90 that the treatment stop signal is not inputted, the analyzing unit 301 stops the timer 301a. On the other hand, after the analyzing section 301 stops the timer 301a, the process repeats the steps after step S81.

In step S81, it is determined whether or not an R wave of the third electro-magnetic wave from the left is detected. When the R wave of the third electrocardiographic waveform from the left is not detected (NO in step S81), the processing in step S81 is performed again. In a case where an R wave of the third electrokinetic wave from the left is detected (YES in step S81), in step S82, the analyzer 301 starts the timer 301a at the time of the count time t ₃ .

In the repeated step S83, the analyzing unit 301 determines whether or not the R wave of the rightmost electrokinetic wave has been detected. If the R wave of the rightmost electrocardiographic waveform is not detected (NO in step S83), the processing in step S83 is performed again. The most when the R wave of the electrocardiogram waveforms on the right side is detected (step S83 YES), repeated at the step S84, analyzes the R wave is detected the count time t ₄ of the electrocardiogram waveform of the right-most portion 301 is measured.

In step S85 is repeated, the repeat step S82 and repeat the cycle of R wave of the electrocardiogram waveform beonjjae step S84 3 R wave of electrocardiogram waveform from the far right side of the time, from the left side of the T that is t ₄ -t ₃ (second) ( time obtained by subtracting t ₄ from t ₃ ).

In step S86 is repeated, t ₄ -t calculates a time obtained by multiplying the 0.075 ~ 0.35 to ₃ seconds, and the time obtained by multiplying the 0.075 ~ 0.35 to R wave t ₄ -t ₃ (seconds) from the electrocardiogram wave of the right-most delayed The analyzing unit 301 determines the timing, that is, the time of u ₂ as the output timing of the electric signal.

In the step S87 are repeated, it is determined that the time obtained by multiplying the 0.075 ~ 0.35 to R wave t ₄ -t ₃ (seconds) from the electrocardiogram waveforms on the right timing delayed, that is, analysis section 301 whether or not the time of u ₂ . Here, if it is discriminated that the time of u ₂ (step S87 YES), the process if it is not determined, and then proceeds to step S88, that the time of u ₂ (step S87 NO), the re-processing of the step S87 Repeat.

The step S88 is repeated, at the time of u _2, generates and outputs the electrical stimulation device 100, the electrical signal generated trigger signal to the trigger signal section 302 for outputting to.

In step S89, it is determined whether 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 determined that the treatment stop signal has not been input (NO in step S89), the process repeats the processing in step S91 and subsequent steps.

Here, according to the electric stimulation apparatus 100 of the second modification, electric signals are output one by one for each continuous heartbeat (electrocardiographic waveform). Therefore, it is possible to supplement blood circulation one by one for each continuous heartbeat (electrocardiographic waveform). Therefore, as compared with the electric stimulation apparatus 100 that continuously outputs the electric signals with respect to each of the R waves of the continuous electrocardiographic waveform, it is possible to alleviate the burden on the human body P caused by the assistance of blood circulation .

Example

Next, an embodiment will be described and the blood circulation assist system 1 of the present embodiment will be described in more detail. However, the technical scope of the present invention is not limited to these embodiments.

(Example 1)

The ECG data acquisition device 200 and the ECG data analysis device 300 are connected. The ECG data analyzing apparatus 300 to which the ECG data obtaining apparatus 200 is connected is connected to the electrical stimulation apparatus 100. [ A detection electrode extending from the electrocardiograph data acquisition device 200 was mounted on the subject's chest. The -electrodes provided in the electric stimulation apparatus 100 were mounted on the left and right ankles of the subject A, respectively. The + electrodes provided on the electric stimulation apparatus 100 were respectively mounted on the lower portions of the left and right thighs of the subject A (above the knees). The electrocardiogram data was acquired from the subject A, and an electric signal having a pulse waveform was output to the hip portion in synchronization with the continuous electrocardiographic waveform. The electric signal is output from the R wave at a timing delayed by 0.10 times the latest cycle T of the R wave, and is output successively to each R wave of the continuous ECG waveform. On the other hand, the output time of the electric signal is set to 0.2 seconds, the pulse width of the electric signal is set to 260 microseconds, the frequency of the electric signal is set to 20 Hz, and the electric current value of the electric signal is set to 10 (A little bit harder).

(Example 2)

Subject A was changed to Subject B. And changed to a current value judged by subject B to be 4 (slightly hard) of the Vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were output to the lower part of the subject B under the same conditions as in the first embodiment.

(Example 3)

Subject A was changed to Subject C. The subject C changed to a current value judged to be 4 (a little bit harder) of the vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were output to the lower part of the subject C under the same conditions as in the first embodiment.

(Example 4)

Subject A was changed to Subject D. The subject D was changed to a current value judged to be 4 (slightly hard) of the vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were output to the lower part of the subject D under the same conditions as in the first embodiment.

(Example 5)

Subject A was changed to Subject E. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.15. The subject E was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were outputted to the lower part of the subject E under the same conditions as in the first embodiment.

(Example 6)

Subject A was changed to Subject F. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.25. The subject F was changed to a current value judged to be 4 (slightly hard) of the vogue scale classified into 10 levels. Other than these conditions, an electric signal was output to the lower part of the subject F under the same conditions as in the first embodiment.

(Example 7)

Subject A was changed to Subject G. [ The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.075. The subject G was changed to a current value judged to be 4 (slightly hard) of the vogue scale classified into 10 levels. Other than these conditions, an electric signal was output to the lower part of the subject G under the same conditions as in the first embodiment.

(Example 8)

Subject A was changed to Subject H. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.075. The subject H was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. Other than these conditions, an electric signal was outputted to the lower part of the subject H under the same conditions as in the first embodiment.

(Example 9)

Subject A was changed to Subject I. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.35. And changed to a current value judged by subject I to be 4 (slightly hard) of the vogue scale classified into 10 levels. Other than these conditions, electric signals were output to the lower part of the subject I under the same conditions as in the first embodiment.

(Example 10)

Subject A was changed to Subject J. Electrodes provided in the electric stimulation apparatus 100 were attached to the right and left groin portions and left and right ankles of the subject J, respectively, and the positive electrode was attached to the lower portion (on the knee) of the left and right thighs of the subject J. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.10. The subject J was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were output to the thigh and the lower leg of the subject J under the same conditions as in Example 1. [

(Example 11)

The subject J was changed to the subject K. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.35. The subject K was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. Other than these conditions, electric signals were output to the thigh and the lower leg of the subject K under the same conditions as in the tenth embodiment.

(Comparative Example 1)

The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.017. The subject A changed the current value to 4 (slightly hard) of the Vogue scale classified into 10 levels. The conditions other than the above were such that electric signals were output to the lower part of the subject A under the same conditions as in the first embodiment.

(Comparative Example 2)

The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.017. And changed to a current value judged by subject B to be 4 (slightly hard) of the Vogue scale classified into 10 levels. The conditions other than the above were such that the electric signal was outputted to the lower part of the subject B under the same conditions as in the second embodiment.

(Comparative Example 3)

The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.017. The subject D was changed to a current value judged to be 4 (slightly hard) of the vogue scale classified into 10 levels. Other than these conditions, an electric signal was output to the lower part of the subject D under the same conditions as in the fourth embodiment.

(Comparative Example 4)

Subject A was changed to Subject L. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.017. The subject L was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. Other than these conditions, an electric signal was output to the lower part of the subject L under the same conditions as in the first embodiment.

(Comparative Example 5)

Except that the output timing of the electric signal was changed from the R wave to the timing delayed by multiplying the latest cycle T of the R wave by 0.05, the electric signal was output to the lower half of the subject H under the same conditions as in Example 8 Respectively.

(Comparative Example 6)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.40, the electric signal was output to the lower half of the subject A under the same conditions as in Example 1 Respectively.

(Comparative Example 7)

Except that the output timing of the electric signal was changed from the R wave to the timing delayed by multiplying the latest cycle T of the R wave by 0.40, the electric signal was outputted to the lower half of the subject B under the same conditions as in Example 2 Respectively.

(Comparative Example 8)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.40, the electric signal was output to the lower half of the subject C under the same conditions as in Example 3 Respectively.

(Comparative Example 9)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.40, the electric signal was output to the lower half of the subject D under the same conditions as in Example 4 Respectively.

(Comparative Example 10)

Except that the output timing of the electric signal was changed from the R wave to the timing delayed by multiplying the latest cycle T of the R wave by 0.40, the electric signal was output to the lower half of the subject I under the same conditions as in Example 9 Respectively.

(Comparative Example 11)

Subject A was changed to Subject M. Electrodes provided in the electric stimulation apparatus 100 were attached to the left and right groin portions of the subject M, respectively, and the + electrodes were attached to the lower portions (above the knee) of the left and right thighs of the subject M. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.25. The subject M was changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. In the other conditions, an electric signal was outputted to the thigh of the subject M under the same conditions as in the first embodiment.

(Comparative Example 12)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.30 to output the electric signal to the thigh of the subject M under the same conditions as in Example 11 Respectively.

(Comparative Example 13)

And the subject M was changed to the subject N. [ The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.10. The subject N is changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. In the other conditions, an electric signal was output to the thigh of the subject N under the same conditions as in Comparative Example 11. [

(Comparative Example 14)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.15, the electric signal was output to the thigh of the subject N under the same conditions as in Comparative Example 13 Respectively.

(Comparative Example 15)

Except that the output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.30 to output the electric signal to the thigh of the subject N under the same conditions as in Comparative Example 13 Respectively.

(Comparative Example 16)

Subject A was changed to subject O. Electrodes provided in the electric stimulation apparatus 100 were attached to the right and left groin portions and right and left ankles of the subject O, respectively, and the + electrodes were attached to the lower portion (knee) of the left and right thighs of the subject O, respectively. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.40. The subject O changed to a current value judged to be 4 (slightly hard) of the Vogue scale classified into 10 levels. Under the other conditions, electric signals were output to the thigh and the lower leg of the subject O under the same conditions as those in the first embodiment.

The current values and the output timings of the electric signals outputted for the subjects of Examples 1 to 11 and Comparative Examples 1 to 16 are shown in Table 1 to be described later.

[Evaluation 1]

For each of the subjects of Examples 1 to 11 and Comparative Examples 1 to 16, arterial pressure waveform of the brachial artery was detected using a blood pressure pulse wave testing apparatus. The detected arterial pressure waveform was confirmed by a doctor and evaluated according to the following evaluation criteria. The results are shown in Table 1 below.

<Evaluation Criteria>

Good: The above-mentioned support waveform can be confirmed in the arterial waveform of at least one heartbeat among the detected arterial pressure waveforms.

Poor: In the detected arterial pressure waveform, the above-described support waveform could not be confirmed.

[Table 1]

As shown in Table 1, in the blood circulatory assist system 1 of Examples 1 to 11, the evaluation results of evaluation 1 were all "Good". From these results, it can be understood that the blood circulatory assist system 1 of Examples 1 to 11 can assist the blood circulation based on the improvement of the blood pump function of the heart. That is, according to the blood circulatory assist system 1 of Examples 1 to 11, it can be understood that blood circulation can be assisted without adversely affecting the self-tuning cardiac contraction expanding function. On the other hand, in the blood circulatory assist systems of Comparative Examples 1 to 16, the evaluation results of evaluation 1 were all 'Poor'. From this result, it can be understood that the blood circulatory assist system 1 of Comparative Examples 1 to 16 can not support blood circulation based on improvement of the blood pump function of the heart. That is, according to the blood circulatory assist system 1 of Comparative Examples 1 to 16, it can be understood that the circulation of the blood can not be assisted without adversely affecting the self-tuning expansion function of the heart.

In particular, from the evaluation results of Evaluation 1 of Comparative Examples 1 to 10 and 16, when the output timing of the electric signal is not made to be a timing delayed by 0.075 to 0.35 times the cycle T from the R wave, the self- It can be understood that the blood circulation can not be assisted without adversely affecting the blood circulation. Even when the output timing of the electric signal is delayed from the R wave by 0.075 to 0.35 times the cycle T from the evaluation result of the evaluation 1 of the comparative examples 11 to 15 and the electric signal is not outputted to the hip area, It can be understood that the blood circulation can not be assisted without adversely affecting the tonic expansion and contraction of the heart.

Next, in addition to the blood circulation assist effect based on improvement of the blood pump function of the heart, the blood circulatory assist system 1 of the present embodiment in which the output time of the electric signal is set to 0.15 seconds to 0.25 seconds, The following examples were carried out in order to show that they have a blood circulation assist effect based on the supplement of

(Example 12)

Subject A was changed to Subject B. The output timing of the electric signal was changed from the R wave to the time delayed by multiplying the latest cycle T of the R wave by 0.30. And changed to a current value judged by subject B to be 4 (slightly hard) of the Vogue scale classified into 10 levels. And outputs one additional electric signal for each R wave of the continuous electrocardiographic waveform detected from the subject B. Under the other conditions, the electric signal was output for 0.2 second to the lower part of the subject B under the same conditions as in the first embodiment.

[Evaluation 2]

For the subject of Example 12, the arterial pressure waveform of the brachial artery was detected using a blood pressure pulse wave test apparatus. The arterial pressure waveform of the subject of Example 12 was checked by a doctor and evaluated according to the following evaluation criteria.

<Evaluation Criteria>

Good: In the arterial pressure waveform of at least one heartbeat among the arterial pressure waveforms having the above-described support waveform, the diastolic blood pressure was less than the diastolic blood pressure of the arterial pressure waveform corresponding to the electrocardiographic waveform to which the electric signal was not output.

Poor: In all of the arterial pressure waveforms having the above-described support waveform, the diastolic blood pressure was equal to or higher than the diastolic blood pressure of the arterial pressure waveform corresponding to the electrocardiographic waveform to which the electric signal was not output.

Table 2 shows the output conditions of the output electric signal and the results of evaluation 2 with respect to the twelfth embodiment.

[Table 2]

As shown in Table 2, in the blood circulatory assist system 1 of Example 12, the evaluation result of Evaluation 2 was "Good". From this result, it is found that the blood circulation assist system 1 of the twelfth embodiment in which the output time of the electric signal is within the range of 0.15 second to 0.25 second has the blood circulation assist effect based on the improvement of the blood pump function of the heart, It can be understood that the blood circulation auxiliary effect is based on the assistance of the blood pump function.

1: blood circulation assist system
11: Output port
12:
13:
14:
15:
16:
60: right electrode part
61:
100: Electric stimulator
101: electric signal output section
102: electrode
200: ECG data acquisition device
201: ECG data acquisition section
300: ECG data analyzing device
301:
203: Trigger signal generation unit

Claims (8)

A blood circulation assist system for assisting the blood circulation of a human body,
An electric stimulation device for outputting a pulse-shaped electric signal to at least a lower part of the human body;
An electrocardiographic data acquisition device for continuously acquiring an electrocardiographic waveform from the human body,
And an ECG data analyzing device for analyzing the ECG waveform acquired by the ECG data acquisition device and determining an output timing of the electrical signal output from the electrical stimulation device,
The electrocardiogram data analyzing apparatus determines a timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform as the output timing,
Wherein 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 method according to claim 1,
Wherein the period T is a recent cycle of the R wave. The method according to claim 1,
Wherein the electrocardiogram data analyzing device determines the output timing each time the R wave is detected. The method according to claim 1,
Wherein said EC data analyzing apparatus alternately repeats the process of determining the output timing when the R wave is detected and the process of not determining the output timing even if the R wave is detected. . The method according to claim 1,
Wherein the electric stimulation apparatus further outputs the electric signal to the femoral region of the human body. 6. The method according to any one of claims 1 to 5,
And the output time of the electric signal within the period T is 0.15 second to 0.25 second. A control method of a blood circulatory assist system for outputting pulse-like electric signals to at least a lower part of a human body, thereby assisting blood circulation by applying electric stimulation to the human body,
Continuously acquiring an electrocardiographic waveform from the human body,
Analyzes the obtained electrocardiographic waveform and determines a timing delayed by a predetermined time from the R wave included in the electrocardiogram waveform as the output timing of the electric signal,
Wherein 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 electric stimulation apparatus for imparting electric stimulation to a human body,
An electric signal output section for outputting an electric signal composed of a pulse wave in synchronization with an electrocardiographic waveform detected from the human body;
And an electrode for transmitting the electric signal to at least a lower part of the human body,
Wherein the electric signal output unit outputs the electric signal at an output timing delayed by a predetermined time from an R wave included in the electrocardiographic waveform,
Wherein the predetermined time is a time obtained by multiplying a cycle T, which is the period of the R wave, by 0.075 to 0.35.

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