JP5557175B2 - Pulsating flow generation control device and pulsating flow generation control method - Google Patents

Description

The present invention relates to a blood circulation path that is externally connected to a human body (same as a patient) with reduced cardiac function and includes a devascularization path and a blood transmission path, and to use the blood circulation path as an auxiliary circulation path, or BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood circulation system including a centrifugal pump for circulating blood to and from an oxygenator, and more specifically, based on measurement of an electrocardiogram waveform and / or a pressure waveform, systole and dilation in a patient's self-beat The present invention relates to a pulsatile flow generation control device and a pulsatile flow generation control method that perform or promote heart disease treatment (assisted circulation treatment) by generating a pulsatile flow synchronized with a period.

Here, the blood circulation system (or a pulsating auxiliary circulation system described later) refers to a device system including a pulsating flow generation control device.

Currently, treatment methods for cardiac function decline vary depending on the severity of the disease. In mild cases, patient life guidance and drug therapy are performed, and advanced treatment devices such as intra-aortic balloon pumping (IABP), percutaneous cardiopulmonary assist (hereinafter referred to as PCPS), and assistive artificial heart are applied as they become severe. Has been. When expanding to a cardiopulmonary apparatus at the time of operation and overviewing the blood circulation system, various prior arts can be referred to and extracted (for example, see Patent Documents 1, 2, 3, 4, 5, 6, 7, 8, and 9). ].
JP-A-6-63124 Japanese Patent Laid-Open No. 10-76002 JP 2000-508950 A Special table 2001-508669 gazette JP 2002-345949 A JP 2004-97611 A JP 2007-43436 A JP 2006-325750 A JP 2007-44302 A

  Under these circumstances, the auxiliary circulation (same as PCPS) is often used as a first choice for cardiogenic shock associated with acute myocardial infarction, and cardiac function deterioration caused by severe acute myocarditis.

  For example, when assisted circulation for the purpose of life support and recovery of cardiac function is performed for patients who have declined cardiac function due to various causes, the treatment period is determined by the patient's condition and therapeutic effect, Compared to extracorporeal circulation (several hours) by an artificial cardiopulmonary apparatus generally used in cardiac surgery, it takes a long time (several days to several weeks). Therefore, blood pumping using a roller pump type heart-lung machine is not suitable because it causes blood cell destruction. For these reasons, it is common for current assisted circulation treatment to use a centrifugal pump for blood transfer. However, there is a problem that a pulsatile flow cannot be supplied to the whole body with a centrifugal pump device that generates a steady flow when the cardiac function of the patient is significantly reduced (described later). In this state, blood flow to the whole body is maintained, but protection of individual organs is often insufficient, especially in the heart, the effect of the diastlic coronary blood flow enhancement function cannot be expected Because.

  As described above, in general, blood feeding by a centrifugal pump is a non-pulsatile flow. In contrast, the living body physiologically supplies pulsatile flow to the whole body by its own mind. The effect is a very important function not only for maintaining the circulation of the whole body but also for protecting each organ. In particular, the heart has a diastolic coronary blood flow increasing function for maintaining coronary artery blood flow by its own pulsation, so that it is particularly necessary to maintain the pulsatile flow.

  However, the current PCPS system is often used in a steady flow because it is adapted in a state where the function of the self-heartedness is reduced and the centrifugal pump cannot generate a pulsating flow.

  Furthermore, continuous perfusion with steady flow carries the risk of increasing the afterload of the recovering heart, and as a result is counterproductive in treatment aimed at restoring cardiac function. With regard to pulsatile flow, in an artificial cardiopulmonary apparatus conventionally used as an assisting means for cardiac surgery, an object generated by the rotation of a roller pump or a balloon placed in a patient's blood vessel as seen in an intra-aortic balloon pumping (IABP) apparatus is used. Some are generated by putting gas in and out, but none of them are satisfactory due to problems with indications, invasion, and cost.

  The problem to be solved by the present invention is that it is not adapted to the cardiac arrest state of the patient as in the cardiopulmonary apparatus in the assisted circulation treatment performed for the patient who has fallen into the cardiac function state. In order to be used while the heart is beating, a pulsatile flow synchronized with the rhythm of the patient's heart must be supplied.

  Here, the timing of synchronization is not driven in synchronization with the patient's electrocardiogram R wave itself as in the conventional defibrillator, but the electrocardiogram R wave is detected and the electrocardiogram T is detected within a predetermined time width. A function capable of adjusting the driving timing at the early stage of the wave is required.

The present invention has been made in view of such circumstances, and in the assisted circulation treatment that is continuously performed on a patient who has fallen into the state of reduced cardiac function, the pulsatile flow is applied to the living body. By providing this, it is possible to maintain the function of increasing diastolic coronary blood flow, increase blood flow in the coronary arteries, and increase the therapeutic effect aimed at restoring cardiac function without applying afterload to the heart A pulsatile flow generation control device and a pulsatile flow generation control method are provided.

In order to solve the problems, the present invention externally connects to a human body ( same as a patient) with reduced cardiac function, and uses a blood circulation path composed of a devascularization path and a blood transmission path, and uses the blood circulation path as an auxiliary circulation path Or a blood circulation system with a centrifugal pump for circulating blood between a human body and an oxygenator,
Based on the measurement of the electrocardiogram and / or pressure waveform, the pulsatile type is designed to implement or promote the treatment of heart disease by generating a pulsatile flow synchronized with the systole and diastole in the patient's self-beat An auxiliary circulation system,
An electromagnetic valve that is provided opposite to the delivery line of the artificial lung in the delivery line, and capable of opening and closing the delivery line by performing a pressure closing or opening operation on the delivery line;
A control device for performing a control output related to the opening and closing operation of the solenoid valve;
A biological signal monitoring device connected to the control device and capable of measuring and displaying a biological signal including at least an electrocardiogram waveform and / or a pressure waveform;
The control device has a pulsating flow generation control means for periodically interrupting blood feeding by maintaining the closing operation of the solenoid valve at a predetermined time width through at least a delay circuit. It is a feature.

In the above blood circulation system or the pulsatile auxiliary circulation system,
Based on the measurement of the electrocardiogram waveform and / or pressure waveform, by periodically operating the blockage and opening of the vascular line to generate pulsatile flow synchronized with the systole and diastole of the patient's self-beat A pulsatile flow generation control device for enforcing or promoting assisted circulation treatment,
A pillow that is provided in the delivery line of the artificial lung in the delivery line, partially expands the diameter of the pipeline section, and temporarily stores blood;
An electromagnetic valve provided opposite to the pillow and capable of opening and closing the blood-feeding passage by performing a pressure closing or opening operation of the pillow;
Control means for performing a control output related to the opening and closing operation of the solenoid valve;
A biological signal monitoring device connected to the control means, capable of measuring a biological signal including at least an electrocardiogram waveform and / or a pressure waveform and capable of outputting an image display ;
The control means includes an electrocardiographic waveform amplification circuit, a waveform shaping circuit, a delay circuit, an electromagnetic valve current switching control circuit, and an electromagnetic valve switch, amplifies the electrocardiographic waveform collected from the patient, and thresholds by waveform shaping processing In synchronization with detection of the peak of the electrocardiogram R waveform (same as the trigger waveform) that has reached 1, signals are sent to the solenoid valve and the delay circuit, respectively, and the closing operation drive input signal and the delay related to the start of energization of the solenoid valve A predetermined time corresponding to the detection of the electrocardiogram waveform, used as a starting point input signal to the circuit, and also used as an opening operation drive input signal related to deenergization by sending the output signal from the delay circuit to the solenoid valve The control output related to the closing operation release based on the energization maintenance of the solenoid valve and the closing operation release based on the energization release (same as the opening operation drive) is repeated in the width,
The predetermined time width is a set delay time of the delay circuit, and a timing is set for a time difference starting from the peak of the electrocardiogram R waveform that has reached the threshold and starting from the initial generation of the electrocardiogram T waveform. ,
The pillow is closed or opened by the electromagnetic valve to synergize the generation of pulsatile flow and pulse pressure.

In the blood circulation system or the pulsation type auxiliary circulation system,
A pillow that is provided in a pipeline on the delivery side of the artificial lung in the blood-feeding channel, partially expands the cross-section of the pipeline, and temporarily stores blood; provided opposite to the pillow, An electromagnetic valve capable of opening and closing the blood-feeding vessel path by a pressure closing or opening operation; an electrocardiographic waveform amplification circuit, a waveform shaping circuit, a delay circuit, and an electromagnetic valve current for performing a control output related to the opening and closing operation of the electromagnetic valve A control means having an open / close control circuit and a solenoid valve switch; and a biological signal monitoring device connected to the control means and capable of measuring a biological signal including at least an electrocardiogram waveform and / or a pressure waveform and capable of displaying an image. The device system is configured, and based on the measurement of the biological signal, the vascular flow is blocked and opened periodically to generate pulsatile flow synchronized with the systole and diastole of the patient's self-pulsation. To implement or promote heart disease treatment A pulsatile flow generation control method in,
A closed operation drive input signal related to the start of energization of the solenoid valve in synchronism with the peak detection of the electrocardiogram R waveform (same as the trigger waveform) that has amplified the electrocardiogram waveform collected from the patient and reached the threshold by the waveform shaping process And sending signals as starting point input signals to the delay circuit,
And also performs a control output to send the output signal from the delay circuit as a closing operation release signal related to the release of energization to the solenoid valve,
A closing operation is driven based on the start of energization of the solenoid valve, and the closing operation is maintained based on the energization maintenance for a predetermined time width (same as the set delay time) corresponding to the detection of the electrocardiogram waveform. Based on the energization cancellation, repeat the opening / closing operation to release the closing operation (same as the opening operation drive)
The pillow is closed or opened by the electromagnetic valve to synergize the generation of pulsatile flow and pulse pressure.

  According to the present invention, it is possible to provide a physiological pulsatile flow even to a patient who has suffered severe cardiac function deterioration, and the auxiliary circulation effect can be increased.

  Specifically, pulsatile flow is provided to the living body in the assisted circulation treatment performed for patients who have fallen into cardiac function, thereby maintaining the diastolic coronary blood flow increasing function and increasing coronary blood flow. Let In addition, selective assisted circulation in the diastole is possible, and as a result, a pressure-boosting effect of P + ΔP can be expected with respect to the diastolic pressure P of the self-heart, so that the secondary action increases coronary blood flow and cardiac function. You can hope for recovery. For this reason, in the auxiliary circulatory treatment performed continuously, the therapeutic effect aiming at recovery of cardiac function can be increased without giving an afterload to the heart.

The best mode for carrying out the present invention is a pulsating flow generation control device having the above configuration, wherein the pulsating pressure is 20 to 50 mmHg.

In the pulsatile flow generation control method configured as described above, the predetermined time width is the set delay time of the delay circuit, the peak of the electrocardiogram R waveform reaching the threshold is set as the starting point, and the initial generation of the electrocardiogram T waveform is set as the end point The time difference is set as a timing, and the pulse pressure is 20 to 50 mmHg.

FIG. 1 shows a schematic diagram for explaining the configuration of a pulsating type auxiliary circulation system including a pulsatile flow generation control device of the present invention, and an embodiment thereof will be specifically described.

  As shown in the figure, when the cardiac function of a patient is significantly reduced, the pulsation type auxiliary circulation system X substitutes the function to maintain life and to restore the cardiac function.

  As a procedure, a blood removal tube 2 (same as a venous blood feeding blood vessel) is connected to a blood removal vessel placed in the patient's vein to form a blood removal route, and the blood is sent to the blood feeding vessel placed in the patient's artery. A blood supply path is configured by connecting blood tubes 8 (same as arterial blood supply blood vessels).

  By the rotation of the centrifugal pump 3, negative pressure is generated in the blood removal tube 2 [blood removal path], and the patient's venous blood is guided to the centrifugal pump 3. Therefore, the venous blood that has become positive pressure is sent to the artificial lung 5 and is oxygenated to become arterial blood, which is supplied to the patient through the blood feeding tube 8 (blood feeding channel).

  In order to generate a pulsating flow in this series of processes, a small electromagnetic valve 7 is attached to the blood supply tube 8 [blood supply line], and the blood supply tube 8 (including the elastic blood supply line 6) is closed. Provide pulsatile flow to the patient by repeated opening.

  Selection of the drive of the solenoid valve 7 includes a fixed number of times specification (mainly used in an emergency: when a patient's electrocardiogram waveform cannot be captured) and a synchronous specification.

  Optimally, it is a synchronous specification, and since the diastolic coronary blood flow increasing function works in the diastole of the heart, the blood feeding tube 8 [blood feeding channel] by the electromagnetic valve 7 at the beginning of the T wave on the electrocardiogram waveform. Is to be released.

  For this purpose, the patient's electrocardiogram is acquired from the electrocardiograph 13 and the R wave is detected, and the delay valve (same as the delay circuit) is used to adjust the drive of the solenoid valve to the systolic and diastolic phases of self-pulsation (synchronized) Function).

  Here, as shown in the operation system of the control device in FIG. 2, in order to exert the effect of the function of increasing the diastolic coronary blood flow, a drive start switch 110 and an electrocardiogram waveform are provided in the control box [control device 11]. Amplification rate adjustment operation means 111 for variably adjusting the amplification rate, an R wave sensitivity adjustment operation means 112 for adjusting the number of times the electromagnetic valve 7 is driven to the patient's pulse rate (heart rate), T-wave delay adjusting operation means 113 is provided for opening the electromagnetic valve 7 at the initial stage of the T-wave to open the blood-feeding tube 8 [blood-feeding channel].

  The extracorporeal blood removal tube 2 and blood supply tube 8 (including the elastic blood supply tube 6) are elastic tubes and are made of a resin material having a relatively high elasticity for the purpose of preventing obstruction and bending, preferably chloride. Vinyl is used. This is because even if the solenoid valve 7 is closed by pressure, if the switch is turned off, the open state can be restored immediately due to its elasticity.

  That is, the pressure closing by the electromagnetic valve 7 and the opening by the elasticity of the tube are continuously generated, and it is possible to provide a physiological pulsating flow even for the auxiliary circulation performed under the steady flow. is there.

  Next, the setting of the delay timer (same as the delay circuit) will be described.

  Under physiological circulatory dynamics, the blood flow of the coronary artery, which is the heart's nutritional blood vessel, is not pushed away during the systole of the heart, but rather is drawn into the coronary artery by negative pressure action during the diastole.

  Therefore, in a state where the cardiac function is lowered, sufficient pulsation does not occur, and this diastolic coronary blood flow increasing function may not work effectively. In other words, if blood flow by the auxiliary circulation can be selectively provided during the diastole of the heart, the blood pressure in the diastole increases, and as a result, the blood flow in the coronary artery increases, which is an effective means for restoring cardiac function.

  Therefore, in order to adjust the opening point of the solenoid valve 7 to the patient's diastole, the R wave is detected from the patient's electrocardiogram waveform, and the T wave delay adjusting means 113 is used at the beginning of the T wave indicating the patient's diastole. It sets so that the solenoid valve 7 may open | release.

  In summary, when the auxiliary circulation is performed, the centrifugal pump 3 is rotated by the magnetic force transmission method. By rotation, negative pressure is generated on the blood removal tube 2 [blood removal path] side, and the venous blood of the patient is guided. The venous blood is drawn to the centrifugal pump 3 through the blood removal tube 2 (blood removal passage), where it changes to positive pressure and is sent to the oxygenator 5.

  The blood oxygenated by the artificial lung 5 becomes arterial blood and is sent to the patient's artery through the blood feeding tube 8 [blood feeding channel]. However, the centrifugal pump 3 is a device that generates a steady flow and cannot provide a physiological pulsatile flow.

  Therefore, a simple electromagnetic valve 7 is attached to the blood supply side, and mechanical clotting and opening are continuously applied to the blood supply tube 8 [blood supply channel] to give a pulsatile flow to the living body.

  The electromagnetic valve 7 is controlled by a control box 11 and opens and closes according to the patient's pulse rate (same as the heart rate).

  Optimally, in order to make the auxiliary circulatory therapy effective, if the electrocardiogram waveform of the patient can be measured, the R wave is detected from the monitor, and the electromagnetic valve 7 is detected at the beginning of the T wave indicating the diastole of the heart. It is assumed that the pressure closing / opening time of the solenoid valve 7 is adjusted so that the valve opens.

The pulsating flow generation control device [hereinafter referred to as Example device Y 1] which is an embodiment of the present invention. ] Will be described below with reference to the drawings.

  FIG. 3 is a schematic diagram for explaining the configuration of the embodiment apparatus.

  FIG. 4 is a flow sheet (flow chart) showing the control means (procedure) of the embodiment apparatus.

  FIG. 5 is a time chart showing the time relationship between the electrocardiogram waveform and the solenoid valve opening / closing operation in the example device.

As shown in the drawing, the embodiment device Y is provided in a pipeline on the delivery side of the artificial lung 5 in the blood supply channel 8, partially expands the diameter of the pipeline cross section, and temporarily stores blood ( Paragraph 0069 and FIG. 8, the same shall apply hereinafter)
An electromagnetic valve 7 provided opposite to the pillow, and capable of opening and closing the blood-feeding passage by performing a pressure closing or opening operation of the pillow;
Control means 11 for performing a control output related to opening and closing of the electromagnetic valve 7;
A biological signal monitoring device 13 connected to the control means 11 and capable of measuring and displaying a biological signal including at least an electrocardiographic waveform and a pressure waveform (an electrocardiographic waveform measuring device in the figure);
The control means 11 drives the solenoid valve 7 to open / close at a predetermined time width 24 through at least the delay circuit 16 (maintenance of the closing operation and release of the closing operation) , and the pillow is closed or opened to periodically send blood. The control output for intermittent connection is performed.

Here, the control means 11 includes an electrocardiographic waveform amplification circuit 14, a waveform shaping circuit 15 (including an R wave detection circuit and a trigger generation circuit), a delay circuit 16, a solenoid valve current switching control circuit 17, and a solenoid valve switch 18. The electrocardiogram waveform collected from the patient is amplified, and synchronized with the detection of the peak 22 of the electrocardiogram R waveform 21 (same as the trigger waveform) that has reached the threshold by the waveform shaping process, to the solenoid valve 7 and the delay circuit 16 Each signal is sent and used as a closing operation drive input signal for starting energization to the solenoid valve 7 and a starting point input signal to the delay circuit 16, and an output signal from the delay circuit 16 is sent to the solenoid valve 7 to release the energization. Used as an open operation drive input signal according to the above, the closed operation maintenance based on the energization maintenance of the electromagnetic valve 7 and the close operation release based on the energization release (same as the open operation drive) in a predetermined time width 24 corresponding to the detection of the electrocardiogram waveform 20 ) Is repeated.

The predetermined time width 24 is the set delay time ΔT of the delay circuit 16, and the timing is set to the time difference starting from the peak 22 of the electrocardiogram R waveform 21 that has reached the threshold and ending at the initial generation of the electrocardiogram T waveform. The pillow is closed or opened by the electromagnetic valve 7 to synergize the generation of the pulsating flow and the pulsating pressure. Here, the timing setting (ΔT) can be adjusted while monitoring a dichroic notch (not shown) of the pressure waveform, which is a characteristic waveform during aortic dilatation.

  A specific configuration will be described in detail. As shown in FIG. 3, the distal end of the blood removal vessel 1 inserted from the right femoral vein of the patient H is placed in the vena cava or the right atrium 10, and blood is supplied to the centrifugal pump 3 through the venous blood supply tube 2. Lead. The blood guided to the centrifugal pump 3 receives a centrifugal force due to the rotation of the rotating body in contact with the blood, passes through the connecting tube 4 and is guided to the artificial lung 5. The blood to which oxygen is added by the artificial lung 5 is sent to the elastic blood feeding tube 6, passes through the valve opening / closing port of the electromagnetic valve 7, and returns to the patient's left femoral artery 9 through the arterial blood feeding blood vessel 8. Opening and closing of the electromagnetic valve 7 is controlled by the pulsating flow generation control means 11. After the electrocardiogram waveform (20) obtained by the electrocardiogram waveform measuring electrodes 12a, 12b, and 12c is sent to the electrocardiogram waveform measuring device 13, the signal is drawn simultaneously with the drawing of the electrocardiogram waveform (20) on the monitor screen. It is also sent to the dynamic flow generation control means 11. The pulsatile flow generation control means 11 detects an R wave 22 (21) which is a ventricular systole signal from the electrocardiographic waveform (20), and the electromagnetic valve 7 for a time ΔT corresponding to the ventricular contraction period from the detected time. Is closed to stop blood feeding through the arterial blood feeding blood vessel 8. When the period of ΔT has passed, the solenoid valve 7 opens and starts blood feeding again through the arterial blood feeding blood vessel 8. The time during which blood is sent by opening and closing the electromagnetic valve 7 is just in the diastole of the ventricle, and an effect of enhancing the diastole coronary blood flow can be expected.

  As shown in FIGS. 4 and 5, in order to exert the effect of enhancing the diastolic coronary blood flow, the pulsatile flow generation control means 11 is used during the ventricular systole beginning with the R wave 22 and immediately before the start of the T wave. The blood flow is stopped, and this blood flow is sent through the pulsatile flow generation control means 11 at the end of the systole. Therefore, the signal from the electrocardiogram waveform measuring device 13 is input to the amplifier 14 that amplifies the electrocardiogram waveform 20 to an appropriate voltage and amplified. In order to detect the R wave 22 (21) from the output signal (20) of the amplifier 14, the amplified signal 20 is input to the waveform shaping circuit 15. By appropriately setting the R wave threshold value 21 in the electrocardiogram waveform signal 20, the start time of the R wave 22 is determined, and a trigger waveform 23 corresponding to the time width of the R wave 22 starting from that time is generated. With this trigger waveform 23 as the start time, the delay circuit 16 outputs a pulse signal (25) of ΔT24 having a variable time width. The time width ΔT24 of the pulse signal (25) from the delay circuit 16 is input to the solenoid valve current switching control circuit 17. The electromagnetic valve current switching control circuit 17 closes the electromagnetic valve 7 by passing a current through the electromagnetic valve circuit breaker 18 during the period of ΔT24. When the electromagnetic valve 7 is closed, the elastic blood-feeding tube 6 through which blood flows is closed and the blood flow is cut off for a period of ΔT24. The period of ΔT24 is the myocardial contraction period. When this period ends, the electromagnetic valve 7 opens and blood flows again through the elastic blood supply tube 6. The period during which this blood flow is sent is the ventricular diastole. By repeating this operation, a diastole coronary blood flow enhancement effect is exhibited. Note that “ΔT (electromagnetic valve current conduction time width; set delay time)” indicated by reference numeral 24 and “current conduction time to the solenoid valve (pulse signal)” indicated by reference numeral 25 shown in FIG. 5 are understood interchangeably. I want.

  An outline of the operation will be described below.

  The blood removed from the femoral vein of the patient H is sent to the centrifugal pump 3 through the blood removal path (1, 2). In the centrifugal pump 3, the blood obtains a centrifugal force by the rotation of the rotating body in contact with the blood, and is sent to the artificial lung 5 (oxygenator) by the force. The blood oxygenated by the artificial lung 5 passes through the elastic blood supply tube 6, passes through the opening / closing port of the electromagnetic valve 7, and is returned to the femoral artery 9 of the patient H. At this time, the stoppage and conduction of the blood supply occur through the opening and closing of the electromagnetic valve 7, in other words, the pressure closing and opening of the blood supply tube 8, and as a result, a pulsatile flow is obtained. The time relationship for generating this pulsatile flow is that the blood flow is interrupted during the time ΔT24 (25) from the rise of the R wave 22 of the electrocardiogram 20 to the end of the ventricular systole, and blood is sent during the other periods. It is a relationship that The pulsatile flow generation control means 11 for realizing the pulsatile flow generation includes an amplifying circuit 14 for an electrocardiographic waveform 20, an R wave detecting circuit, and a trigger (pulse) generating circuit starting from the R wave 22 (21). A waveform shaping circuit 15 including a delay pulse generation circuit 16 (delay circuit) that receives a trigger input and generates a pulse having a time width 24 of ΔT, and receives a pulse from the delay circuit 16 to generate a current to the solenoid valve 7. It consists of a solenoid valve circuit breaker 18 (and solenoid valve 7) that conducts or shuts off. Actually, during the pulse generation period of ΔT (24) (25), the current to the solenoid valve 7 is turned on to close the solenoid valve 7, thereby closing the blood feed tube 8 and blocking the blood flow. The blood flow is interrupted only during ΔT24 in one cycle of the heartbeat, and the blood flow is sent through the patient's femoral artery 9 during other periods. This period during which blood is supplied corresponds to the diastole of the ventricle and can exert a diastole coronary blood flow enhancement effect, contributing to the recovery of the patient's myocardium.

  The pulsatile flow described here generates blood that is superimposed on the pulsatile flow caused by the self-heart of the patient H, and additionally increases the blood pressure when the blood pressure falls during the diastole of the self-heart. The purpose is to promote blood flow to the coronary arteries, and thereby exert the effect of enhancing the diastolic coronary blood flow, and when the patient's heart cannot obtain sufficient diastolic blood pressure due to heart disease And promotes recovery of the heart.

  Further, the electromagnetic valve 7 described here is closed only while a current flows through a coil that drives the electromagnetic valve 7, and no pressure is generated in the valve during a period when the current is not flowing. The valve is opened by the restoring force of the blood supply tube 6). This is the reason why the elastic tube is used.

  The amplifier 14 in FIG. 5 is an amplifier that amplifies the electrocardiogram waveform, and the amplification factor is variable (amplification factor adjusting operation means 111 in FIG. 2). This amplifier can be easily realized by using an operational amplifier. There are individual differences in the magnitude of the electrocardiogram waveform voltage, and in order to adjust this and facilitate the subsequent processing, the input waveform R wave 22 (21) to the waveform shaping circuit 15 is sufficiently large using this amplifier 14. Adjust so that

  The waveform shaping circuit 15 is a circuit that detects the R wave 22 and generates an input pulse to the delay circuit 16, and can be realized by using a comparator circuit (same as the R wave detection circuit). Since the peak voltage value of the R wave 22 varies depending on the patient H, the threshold value 21 can be freely set so that the R wave 22 can be detected efficiently (R wave sensitivity adjusting operation means 112 in FIG. 2).

  The input pulse to the delay circuit 16 output from the waveform shaping circuit 15 is converted into a delay pulse having a time width ΔT24 (25) by using the delay circuit 16 (T-wave delay adjusting operation means 113 in FIG. 2). The time width ΔT24 (25) representing the cardiac contraction period depends on the heartbeat period T of the patient H, and since there are individual differences, the time width 25 can be artificially changed. Various methods for realizing the delay circuit 16 can be considered. For example, the delay circuit 16 can be realized by using a timer 555 which is an IC element.

  Since the operation of the solenoid valve 7 requires, for example, 15 W or more of electric power, a current of 0.6 A or more must be supplied to the solenoid valve 7 from a 24V DC power supply. For this reason, a relay element (electromagnetic valve circuit breaker 18) is used to control conduction and interruption of the current. The relay (18) is a kind of switch, and the pulse (25) of ΔT (24) opens and closes the relay (18). The relay (18) is closed during the time width (24) of ΔT, and while the relay (18) is closed, current is supplied to the solenoid valve 7 and the auxiliary blood flow [using this device Y (X)]. The tube 6 supplying the obtained pulsatile blood flow is closed to block the auxiliary blood flow.

  When the input of the pulse (25) of ΔT (24) disappears, the relay (18) is cut off, the current to the solenoid valve 7 is stopped, the arterial blood-feeding blood vessel 8 that has been closed is opened, and the auxiliary blood is supplied to the patient H To the aorta 9 This period is the diastole, and the effect of enhancing diastole coronary blood flow is exhibited.

  The pulsatile flow generation control means 11 includes an electrocardiogram waveform 20 so that the response of the pulsatile flow generation control means 11 is appropriate in accordance with changes in the cardiac cycle of the patient H, the cardiac contraction period, and the electrocardiogram waveform 20. The amplification factor, the R wave detection threshold value 21, and the cardiac contraction period ΔT24 (25) can be set appropriately (the same as the operation system 111; 112; 113 of the control box described above).

  As described above, the present invention provides a physiological pulsatile flow to the living body by instrumental means at the time of performing auxiliary circulation in cardiac therapy, and contributes to this field in that an increase in therapeutic effect can be expected. Is great.

  In addition, the clinical effect of the system of the present invention (including the pulsatile flow generation control device) was verified by animal experiments.

  [Experimental purpose] At present, the percutaneous cardiopulmonary support (PCPS) is widely used as the first choice as a treatment method for cardiac function deterioration in the acute phase. However, normal PCPS systems use centrifugal pumps because of their various significance. Furthermore, since the adaptation is performed in a state where the function of the self-heart is lowered, there is a case where a sufficient pulsating flow cannot be obtained and the auxiliary circulation is maintained in a steady flow state. Therefore, in the configuration of the present invention, a device that generates a pulsatile flow that can be synchronized with an electrocardiogram using a simple solenoid valve (same as a pulsatile flow generation control device) has been developed, and its functionality and safety have been verified. It is.

  [Experiment Method] White rabbits (male; 2.5-3.0 kg, n [number of subjects] = 3) were used as subjects.

FIG. 6 shows a circuit configuration explanatory diagram of the system of the present invention (including the pulsatile flow generation control device) in this experiment. The English text in the figure is as follows.
venous line from the right artrium: blood removal from the right atrium (venous)
arterial line to left carotid, A: Blood flow (arterial) to the left common carotid artery
centrifugal pump
oxygenerator: artificial lung
pulsatile generator ： Pulsatile flow generator
control unit: Control unit
EKG monitor: electrocardiograph

  Therefore, for each case (subject), an auxiliary circulation was performed for 12 hours, and the flow rate was controlled in synchronization with the diastole of the electrocardiogram. During the experiment, CPK-MB fraction (creatinine phosphokinase MB fraction) was measured periodically to evaluate cardiac function. FIG. 7 is a data plot showing the change (transition) of the CPK-MB value.

  [Experimental results and discussion] After the experiment was completed, at the part that was driven continuously for 3 hours and 6 hours, an electron micrograph was taken at the part of the pulsating flow generator that was closed by the electromagnetic valve (not shown). As a result of damage evaluation on the inner surface of the circuit (tube), no damage was found and it was confirmed that there was no problem with safety.

Regarding the experimental results, ECG synchronization was possible in all cases, and an increase in diastolic pressure could be confirmed. This suggests that it is also useful for improving cardiac function.

  Furthermore, the application range of the system of the present invention (including the pulsatile flow generation control device) is not limited to the first and second embodiments, and is versatile. For example, even in the myocardial protective injection method used in normal cardiac surgery, a pulsatile flow state that is a physiological fluid characteristic can be easily generated when the myocardial protective liquid is supplied.

  [Experimental Purpose] Therefore, a myocardial protection experimental circuit incorporating a pulsatile flow generation control device was formed, and the fluid characteristics of pulsatile flow myocardial protection were verified.

  [Experiment Method] A 2.0 ml pillow is attached to a commercially available myocardial protection circuit, and the pulsatile flow generator of the present invention is driven to measure the maximum pressure / minimum pressure before (A) and after (B) the pillow. did. As the fluid, a commercially available myocardial protective solution (St. Thomas II solution) was used.

FIG. 8 shows a configuration explanatory diagram of a pulsatile flow myocardial protection experimental circuit. The English text in the figure is as follows.
cardioplegia reserver: blood reservoir
roller pump: roller pump
pillow: pillow
pulsatile generator ： Pulsatile flow generator
control unit: Control unit

  [Experimental Results and Discussion] The measurement results shown in Table 1 are the average values of 10 times of measured blood, and the numbers after the decimal point are rounded down. In addition, (a) of Table 1 is a reference data and shows the case of steady flow (pulsating flow generator OFF).

  As shown in Table 1, even in a normal myocardial protection system using a roller pump, a pulse pressure of 20 mmHg could be confirmed (a). On the other hand, in the pulsatile myocardial protective injection method to which the configuration of the present invention is applied, it was possible to generate a maximum pulse pressure of 50 mmHg (b). Further, since no gas was generated in the circuit during driving, it was confirmed that the present invention can also be applied to the myocardial protective injection method.

  As understood from this experimental fact, if the method of the present invention is applied when supplying the myocardial protective solution, it can be expected to contribute to the improvement of the myocardial protective effect.

  The present invention is capable of supplying a physiological pulsatile flow synchronized with an electrocardiogram in an auxiliary circulatory therapy performed for a decrease in cardiac function.

  Further, even during normal cardiac surgery, it is possible to supply pulsatile flow that was conventionally possible in a cardiac arrest state throughout the circulation of the extracorporeal circulation.

  Furthermore, it is possible to supply physiological pulsatile flow with respect to myocardial protection currently performed in steady flow and cerebral isolated extracorporeal circulation (slective cerebral perfusion) performed in the treatment of thoracic aortic aneurysms, It is also useful from the viewpoint of myocardial protection and brain protection.

It is a composition outline explanatory view of the pulsation type auxiliary circulation system of the present invention. It is explanatory drawing which similarly shows the operation system of a control box [control apparatus]. It is a structure outline explanatory drawing of an Example apparatus (pulsatile flow generation control apparatus). It is a flow sheet (flowchart) which shows the control means (procedure) of an Example apparatus (pulsatile flow generation control apparatus). It is a time chart which shows the time relationship of the electrocardiogram waveform and electromagnetic valve opening / closing operation | movement in an Example apparatus (pulsatile flow generation control apparatus). It is circuit structure explanatory drawing of this invention system (including a pulsatile flow generation control apparatus) of Example 2. FIG. It is a data plot which shows the change (transition) of CPK-MB value which is also an experimental result. FIG. 10 is a configuration explanatory view showing a pulsatile flow myocardial protection experimental circuit described in Example 3;

1. Blood-feeding vessel with blood removal port [Devascularization]
2 Venous blood feeding blood vessels [devascularization]
3 Centrifugal pump 4 Connection pipe [feeding line]
5 Artificial lung (oxygenator)
6 Elastic blood vessel
7 Solenoid valve 8 Arterial blood-feeding blood vessel
9 Left femoral artery
10 Cava or right atrium
11 Control device (pulsating flow generation control means; control means)
110 Drive start switch
111 Gain adjustment control
112 R wave sensitivity adjustment operation means
113 Delay adjustment operation means
12a Electrocardiogram measurement electrode
12b Electrocardiogram waveform measurement electrode
12c Electrocardiogram waveform measurement electrode
13 ECG waveform measuring device (biological signal monitoring device)
14 Amplifier (amplifier circuit)
15 Waveform shaping circuit
16 delay circuit
17 Solenoid valve current switching control circuit
18 Solenoid valve circuit breaker (relay)
20 ECG waveform
21 R-wave detection threshold (voltage)
22 R wave
23 Waveform shaping circuit output waveform
24 ΔT (Solenoid valve current conduction time width; set delay time)
25 Current conduction time to solenoid valve (pulse signal)
26 Time evolution of solenoid valve opening and closing

H patient X pulsatile auxiliary circulation system Y pulsatile flow generation control device [Example device]

Claims (4)

A blood circuit that is externally connected to the human body (same as the patient) with reduced cardiac function and is composed of a devascularization channel and a blood transmission channel, and the blood circuit is used as an auxiliary circuit, or between the human body and the oxygenator A blood circulation system with a centrifugal pump for circulating blood between them,
Based on the measurement of the electrocardiogram waveform and / or pressure waveform, by periodically operating the blockage and opening of the vascular line to generate pulsatile flow synchronized with the systole and diastole of the patient's self-beat A pulsatile flow generation control device for enforcing or promoting assisted circulation treatment,
A pillow that is provided in the delivery line of the artificial lung in the delivery line, partially expands the diameter of the pipeline section, and temporarily stores blood;
An electromagnetic valve provided opposite to the pillow and capable of opening and closing the blood-feeding passage by performing a pressure closing or opening operation of the pillow;
Control means for performing a control output related to the opening and closing operation of the solenoid valve;
A biological signal monitoring device connected to the control means, capable of measuring a biological signal including at least an electrocardiogram waveform and / or a pressure waveform and capable of outputting an image display ;
The control means includes an electrocardiographic waveform amplification circuit, a waveform shaping circuit, a delay circuit, an electromagnetic valve current switching control circuit, and an electromagnetic valve switch, amplifies the electrocardiographic waveform collected from the patient, and thresholds by waveform shaping processing In synchronization with detection of the peak of the electrocardiogram R waveform (same as the trigger waveform) that has reached 1, signals are sent to the solenoid valve and the delay circuit, respectively, and the closing operation drive input signal and the delay related to the start of energization of the solenoid valve A predetermined time corresponding to the detection of the electrocardiogram waveform, used as a starting point input signal to the circuit, and also used as an opening operation drive input signal related to deenergization by sending the output signal from the delay circuit to the solenoid valve The control output related to the closing operation release based on the energization maintenance of the solenoid valve and the closing operation release based on the energization release (same as the opening operation drive) is repeated in the width,
The predetermined time width is a set delay time of the delay circuit, and a timing is set for a time difference starting from the peak of the electrocardiogram R waveform that has reached the threshold and starting from the initial generation of the electrocardiogram T waveform. ,
A pulsating flow generation control device characterized in that the generation of pulsating flow and pulsating pressure is made synergistic by closing or opening the pillow with the electromagnetic valve.   The pulsatile flow generation control device according to claim 1, wherein the pulsating pressure is 20 to 50 mmHg. A blood circuit that is externally connected to the human body ( same as the patient) with reduced cardiac function and is composed of a devascularization channel and a blood transmission channel, and the blood circuit is used as an auxiliary circuit, or between the human body and the oxygenator A blood circulation system with a centrifugal pump for circulating blood between them,
A pillow that is provided in a pipeline on the delivery side of the artificial lung in the blood-feeding channel, partially expands the cross-section of the pipeline, and temporarily stores blood; provided opposite to the pillow, An electromagnetic valve capable of opening and closing the blood-feeding vessel path by a pressure closing or opening operation; an electrocardiographic waveform amplification circuit, a waveform shaping circuit, a delay circuit, and an electromagnetic valve current for performing a control output related to the opening and closing operation of the electromagnetic valve and control means having a switching control circuit and the solenoid valve switch; connected to the control means comprises an image display capable of outputting the biological signal monitoring apparatus capable of measuring a bio signal including at least the electrocardiographic waveform and / or pressure waveform The device system is configured, and based on the measurement of the biological signal, the vascular flow is blocked and opened periodically to generate pulsatile flow synchronized with the systole and diastole of the patient's self-pulsation. To implement or promote heart disease treatment A pulsatile flow generation control method in,
A closed operation drive input signal related to the start of energization of the solenoid valve in synchronism with the peak detection of the electrocardiogram R waveform (same as the trigger waveform) that has amplified the electrocardiogram waveform collected from the patient and reached the threshold by the waveform shaping process And sending signals as starting point input signals to the delay circuit,
And also performs a control output to send the output signal from the delay circuit as a closing operation release signal related to the release of energization to the solenoid valve,
A closing operation is driven based on the start of energization of the solenoid valve, and the closing operation is maintained based on the energization maintenance for a predetermined time width (same as the set delay time) corresponding to the detection of the electrocardiogram waveform. Based on the energization cancellation, repeat the opening / closing operation to release the closing operation (same as the opening operation drive)
A pulsatile flow generation control method characterized in that the generation of pulsatile flow and pulsation pressure is made synergistic by closing or opening the pillow with the electromagnetic valve. The predetermined time width is the set delay time of the delay circuit, and the timing is set to the time difference starting from the peak of the electrocardiogram R waveform reaching the threshold and ending at the initial generation of the electrocardiogram T waveform,
The pulsatile flow generation control method according to claim 3, wherein the pulse pressure is 20 to 50 mmHg.

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