JPWO2018159501A1 - Driving method of balloon by IABP driving device and IABP driving device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a method of driving a balloon by an IABP driving device capable of preventing formation of a thrombus on a balloon surface. A method of driving a balloon by an IABP driving device that attaches a balloon catheter to which a balloon is connected and expands and contracts the balloon, wherein the balloon is continuously synchronized with a heartbeat having a heart rate of 120 bpm or more. When performing the high-speed continuous drive for driving the balloon, if the high-speed continuous drive lasts for a predetermined time of 30 seconds or more, after performing a resting operation for maintaining the balloon in a deflated state for a predetermined number of heartbeats, The high-speed continuous driving is performed again. [Selection diagram] FIG.

Description

  The present invention relates to a balloon driving method and an IABP driving device using an IABP driving device used in an IABP (intra-aortic balloon pumping) method.

  In the IABP method, in order to obtain a sufficient assisting (reducing the burden on the heart), it is necessary to expand and contract the balloon placed in the aorta at a timing appropriate for the heartbeat of the patient. Therefore, in a driving device that drives a balloon of a balloon catheter in the IABP method, a signal related to the heartbeat of a patient acquired by an electrocardiograph or a sphygmomanometer is input, and the balloon is expanded and contracted based on the signal. That is, in the IABP driving device, the number of repetitions of the operation of expanding and deflating the balloon per unit time increases as the patient's heart rate increases, and decreases as the patient's heart rate decreases (see Patent Document 1). .

  The IABP driving device expands and contracts the balloon by alternately applying positive pressure and negative pressure to a piping system that transmits pressure to the balloon. Here, the positive pressure and the negative pressure applied to the piping system are generated by a pump, and the positive pressure and the negative pressure generated by the pump are maintained at substantially constant pressures in the positive pressure tank and the negative pressure tank, respectively. That is, the pressure of each positive pressure / negative pressure tank is temporarily reduced or increased by applying a positive pressure or a negative pressure to a piping system for transmitting pressure to the balloon, but is increased or decreased by a pump. Is returned to the pressure before transmitting the pressure to the balloon.

  However, when the patient's heart rate increases, the pump's pressurizing / depressurizing ability cannot keep up, and the next cycle is started before the pressure of each positive / negative pressure tank returns to the pressure which should be originally reached. There is. In such a state, there is a problem that the internal pressure of the balloon, which should be kept constant even if the heart rate changes, and the state of the balloon at the time of inflation and deflation are affected by the heart rate. However, even if the pressure difference between the positive pressure and the negative pressure applied to the piping system decreases with an increase in the heart rate, if the pressure difference is equal to or greater than a certain value, a certain heart rate is obtained by driving the balloon. It is possible to generate a function assisting effect.

International Publication No. 2011/114779

  However, when the pressure applied to the balloon by the IABP driving device decreases with an increase in the heart rate, the balloon cannot be completely inflated even during the inflation, so that a thrombus is easily formed on the surface of the balloon. May become For example, when the balloon does not completely expand even during expansion and the balloon membrane is always in a slack state, the state in which the balloon surface is uneven is maintained, and blood stays in the dent portion for a long time, resulting in a thrombus. Is likely to be formed. The risk of such thrombus formation is that the balloon is often driven in synchrony with a high heart rate because tachycardia and arrhythmia are common in patients with reduced heart function to which the IABP method is applied. Should be avoided.

  The present invention has been made in view of such circumstances, and relates to a balloon driving method and an IABP driving device using an IABP driving device capable of preventing formation of a thrombus on the balloon surface.

In order to achieve the above object, a method for driving a balloon according to the present invention includes:
A method of driving a balloon by an IABP driving device that attaches a balloon catheter to which a balloon is connected and expands and contracts the balloon,
When performing high-speed continuous driving for driving the balloon continuously in synchronization with a heart rate having a heart rate of 120 bpm or more, if the high-speed continuous driving continues for a predetermined time of 30 seconds or more, a predetermined number of heartbeats On the other hand, after performing a resting operation for maintaining the balloon in the deflated state, the high-speed continuous driving is performed again.

  The driving method of the balloon according to the present invention detects a state in which the high-speed continuous driving which may not be able to completely expand the balloon continues for a predetermined time, performs a pause operation when detecting this, and then performs the high-speed continuous driving again. carry out. In the expansion performed immediately after the resting motion, the same pressure as that at the time of low-speed driving can be transmitted to the balloon, so that the balloon can be fully expanded or can be expanded to a state close to full expansion as compared to the time immediately before the expansion. Therefore, according to such a balloon driving method, it is possible to prevent the time during which the balloon cannot be completely expanded from continuing beyond the predetermined time, thereby preventing the problem that a thrombus is formed on the surface of the balloon.

  In addition, for example, the heartbeat operation may be performed once at a rate of 60 to 180 times.

  According to such a driving method, a higher heart function assisting effect can be achieved as compared with a balloon driving method in which the assist ratio is set to 1: 2, for example.

Further, the IABP driving device according to the present invention includes:
Attach a balloon catheter to which a balloon is connected, a balloon driving unit that drives the balloon by alternately applying positive pressure and negative pressure to a piping system that transmits pressure to the balloon,
A control unit that controls the balloon driving unit, so that a heartbeat signal that is a signal related to a heartbeat is input, so that the balloon expands and contracts in synchronization with a heartbeat.
When the balloon driving unit continuously drives the balloon in synchronization with the heartbeat for a predetermined time of 30 seconds or more while the heart rate is 120 bpm or more, the control unit controls the balloon for a predetermined number of heartbeats. After performing a resting operation for maintaining the balloon in a deflated state, the balloon driving unit is controlled so as to drive the balloon continuously again in synchronization with a heartbeat.

  The control unit of the IABP driving device according to the present invention, when the balloon is driven for a predetermined time of 30 seconds or more under a condition that the balloon may not be completely inflated, gives a predetermined number of heartbeats to the balloon driving unit. On the other hand, a resting motion for keeping the balloon in the deflated state is performed. In the expansion performed immediately after the resting motion, the same pressure is transmitted to the balloon as when synchronizing to a slower heart rate. One time immediately after the beat, it can be said that the balloon can be fully expanded or expanded to a state closer to full expansion. Therefore, according to the IABP driving device having such a control unit, it is possible to prevent the time during which the balloon cannot be completely expanded from continuing beyond a predetermined time, thereby preventing a problem that a thrombus is formed on the surface of the balloon. Can be prevented.

FIG. 1 is an overall external view of an IABP driving device according to an embodiment of the present invention. FIG. 2 is a block diagram showing a schematic structure of the IABP driving device shown in FIG. FIG. 3 is an external view of the monitor section viewed from the front. FIG. 4 is a graph showing an example of the relationship between the balloon expansion capacity and the synchronized heart rate after synchronous driving for 10 seconds by the IABP driving device shown in FIG. FIG. 5 is a graph showing an example of an internal pressure waveform of a balloon by the IABP driving device shown in FIG. FIG. 6 is a flowchart showing an example of a balloon driving method performed by the IABP driving device shown in FIG. FIG. 7 is a flowchart illustrating another example of a balloon driving method performed by the IABP driving device illustrated in FIG. 1.

  Hereinafter, an IABP driving device according to the present invention will be described in detail based on an embodiment shown in the drawings.

  FIG. 1 is an overall external view of an IABP driving device 10 according to an embodiment of the present invention, and FIG. 2 is a block diagram illustrating a schematic structure of the IABP driving device 10. As shown in FIG. 2, the IABP driving device 10 is a driving device used to attach and expand the IABP balloon catheter 90 to which the balloon 92 is connected, and to expand and contract the balloon 92. The balloon catheter 90 is used by being attached to the device main body 20 of the IABP driving device 10 shown in FIG. The balloon 92 connected to the tip of the balloon catheter 90 is used by being placed in the descending aorta. The IABP drive device 10 can assist the blood circulation function of the heart by expanding and deflating the balloon 92 in accordance with the heart beat.

  As shown in FIG. 1, the IABP driving device 10 includes a device main body 20 and a monitor unit 60. Inside the apparatus main body 20, a balloon driving section 20a for expanding and deflating the balloon 92, a power supply means (not shown) for supplying electric power to the expanding / contracting means, and the like are accommodated. A caster 49 is attached to a lower portion of the device main body 20, and the IABP drive device 10 can be easily moved in a hospital or the like.

  The monitor section 60 is attached to the apparatus main body 20 via a monitor installation section 48 provided on the upper surface of the apparatus main body 20. The monitor unit 60 is detachable from the apparatus main body 20. However, the monitor section 60 is connected to the apparatus main body 20 via a cable (not shown) or the like, and receives power supply from the apparatus main body 20, exchanges data with the apparatus main body 20, performs signal transmission, and the like. Input and output.

  As shown in FIG. 2, a balloon drive unit 20a for expanding and deflating the balloon 92 is housed inside the apparatus main body 20. The balloon drive section 20a has a secondary piping system 21b communicating with the inside of the balloon catheter 90, and a primary piping system 21a communicating with the pump 30 as a primary-side pressure generating means. The primary piping system 21a and the secondary piping system 21b are separated by a pressure bulkhead device 25 (isolator). The pressure bulkhead device 25 has a diaphragm 26 that transmits the pressure of the primary piping system 21a to the secondary piping system 21b. In the balloon driving unit 20a, the fluid inside each of the primary piping system 21a and the secondary piping system 21b cannot move between the primary piping system 21a and the secondary piping system 21b, but the pressure (volume) of the primary piping system 21a is increased by the movement of the diaphragm 26. Change) is transmitted to the secondary piping system 21b.

  As described above, the balloon driving unit 20a in which the primary piping system 21a and the secondary piping system 21b are arranged with the pressure bulkhead device 25 interposed therebetween is capable of keeping the capacity (chemical equivalent) of the shuttle gas sealed in the secondary piping system 21b constant. And the advantage that the consumption of the shuttle gas used for the secondary piping system 21b can be suppressed.

  As the internal fluid of the primary piping system 21a, for example, air can be used, and as the internal fluid (shuttle gas) of the secondary piping system 21b, for example, helium gas can be used. By using helium gas having a small viscosity and a small mass as the internal fluid of the secondary piping system 21b, the responsiveness of expansion and contraction of the balloon 92 can be improved.

  As shown in FIG. 2, a pump 30 is disposed in the primary piping system 21a. A positive pressure tank 31 is connected to a positive pressure output port of the pump 30, and a negative pressure tank 35 is connected to a negative pressure generating port of the pump 30. The pump 30 used in the present embodiment shown in FIG. 2 generates positive pressure and negative pressure at the same time by driving. A pump (compressor or the like) that generates positive pressure and a pump (such as a compressor) that generates negative pressure are used. And a vacuum pump).

  The positive pressure tank 31 and the negative pressure tank 35 include a positive pressure regulating valve 32 and a negative pressure regulating valve 36 for selectively opening and closing the communication between the inside of each of the tanks 31 and 35 and the outside (atmosphere); A pressure sensor for measuring the internal pressure of each of the pressure tanks 31 and 35 is provided, and the positive pressure tank 31 and the negative pressure tank 35 are controlled so as to maintain a substantially constant internal pressure even while the balloon 92 is being driven. The internal pressures of the positive pressure tank 31 and the negative pressure tank 35 are not particularly limited. For example, the pressure PT1 of the positive pressure tank 31 is maintained at 300 mmHg (gauge pressure), and the pressure PT2 of the negative pressure tank 35 is maintained at -150 mmHg (gauge pressure). Is controlled.

  The positive pressure tank 31 and the negative pressure tank 35 are connected to the input end of the pressure bulkhead device 25 via a positive pressure side solenoid valve 28 and a negative pressure side solenoid valve 29 which are independently opened and closed. The balloon drive unit 20a can expand and contract the balloon 92 by switching the open / close state of the positive pressure side solenoid valve 28 and the negative pressure side solenoid valve 29.

  On the other hand, the secondary piping system 21b connected to the balloon catheter 90 is filled with a shuttle gas that flows through the balloon catheter 90 and expands and contracts the balloon 92. The secondary piping system 21b is provided with a measurement unit 22 for measuring the balloon internal pressure, which is the internal pressure of the balloon 92, and an adjustment unit 24 for adjusting the balloon internal pressure. The measurement unit 22 is configured by a pressure sensor or the like, and measures the pressure inside the balloon catheter 90 filled with the shuttle gas. An internal pressure signal, which is a signal related to the balloon internal pressure measured by the measurement unit 22, is output to the control unit 62 of the monitor unit 60.

  The adjustment unit 24 adjusts the amount of shuttle gas flowing through the secondary piping system 21b and the balloon catheter 90 to expand the balloon 92, and adjusts the balloon internal pressure. For example, the adjustment unit 24 supplies the shuttle gas to the secondary piping system 21b or discharges the shuttle gas from the secondary piping system 21b to increase the reference pressure which is the balloon internal pressure when the balloon 92 is deflated. Alternatively, the pressure in the balloon is adjusted by lowering the pressure.

  As shown in FIG. 2, the monitor unit 60 includes a control unit 62, a display unit 64, an operation signal input unit 68, a pilot lamp 70, and a heartbeat signal input unit 69. As shown in FIG. 3, the display unit 64 is disposed in a region of about the upper half of the front surface of the monitor unit 60 and is configured by a display such as a liquid crystal display or an organic EL display.

  The control unit 62 is configured by a microprocessor or the like, and controls various components of the balloon driving unit 20a, the display unit 64, and the like included in the IABP driving device 10 by performing various arithmetic processes. The pilot lamp 70 notifies the operator of the driving state of the IABP driving device 10 including the abnormality that has occurred in the IABP driving device 10 by changing the lighting color or the lighting / flashing. The lighting state of pilot lamp 70 is controlled by control unit 62.

  As shown in FIGS. 2 and 3, the display unit 64 has a waveform display unit 64a and a blood pressure / heart rate display unit 64b. The waveform display section 64a is arranged at the center of the display section 64, and the waveform display section 64a displays three waveforms side by side in the order of the electrocardiogram waveform 82, the blood pressure waveform 84, and the internal pressure waveform 86. The electrocardiogram waveform 82 displays an electrocardiogram signal representing the electrical activity of the patient's heart. The electrocardiogram signal is acquired by an electrocardiograph via an electrode pad attached to the patient, and is input to the monitor unit 60 via a heartbeat signal input unit 69 shown in FIG. The control unit 62 of the monitor unit 60 displays the electrocardiogram signal input via the heartbeat signal input unit 69 on the waveform display unit 64a as an electrocardiogram waveform 82. In addition, the electrocardiogram signal may be directly acquired by the IABP driving device 10 by incorporating an electrocardiograph in the IABP driving device 10 or via an electrocardiograph (polygraph, bedside monitor, etc.) outside the IABP driving device 10. May be obtained indirectly.

  The blood pressure waveform 84 displays a blood pressure signal indicating the blood pressure of the patient. The blood pressure signal is measured using a pressure transducer or the like attached to the balloon catheter 90 or another catheter connected to the artery, and is input to the monitor unit 60 via the heartbeat signal input unit 69 shown in FIG. . The control unit 62 of the monitor unit 60 displays the blood pressure signal input via the heart rate signal input unit 69 on the waveform display unit 64a as a blood pressure waveform 84.

  The internal pressure waveform 86 indicates an internal pressure signal indicating the internal pressure of the balloon, which is the internal pressure of the balloon 92. As shown in FIG. 2, the internal pressure signal is output by the measurement unit 22 provided in the secondary piping system 21 b of the device main body 20 and is input to the monitor unit 60.

  As shown in FIG. 3, on the right side of the display unit 64, a blood pressure / heart rate display unit 64b for numerically displaying the blood pressure and the heart rate is arranged. In the example shown in FIG. 3, the heart rate, the systolic pressure, the diastolic pressure, the average pressure, and the augmentation pressure are displayed in this order from above the blood pressure / heart rate display unit 64b. The heart rate is calculated by the control unit 62 based on the electrocardiogram signal, and the systolic pressure, diastolic pressure, average pressure, and augmentation pressure are each calculated by the control unit 62 based on the blood pressure signal.

  As shown in FIG. 3, the operation signal input section 68 is disposed below the front surface of the monitor section 60. The operator of the IABP driving device 10 can input various signals related to driving of the IABP driving device 10, such as driving conditions of the balloon 92 and display conditions of the monitor unit 60, via the operation signal input unit 68.

  The operation signal input unit 68 has an adjustment input unit 68a for inputting a signal for adjusting the internal pressure of the balloon 92, and the operator of the IABP driving device 10 presses a push button of the adjustment input unit 68a. Then, an operation signal for adjusting the balloon internal pressure is input to the monitor unit 60. When an operation signal for adjusting the balloon internal pressure is input, the control unit 62 of the monitor unit 60 controls the adjustment unit 24 of the apparatus main body 20 to control the shuttle gas flowing through the secondary piping system 21 b and the balloon catheter 90. The balloon pressure is adjusted by increasing or decreasing the amount (chemical equivalent of helium gas).

  FIG. 4 shows a synchronized heart rate when the balloon 92 having a volume (nominal volume) of 40 ml is expanded and deflated in synchronization with the heartbeat of the patient by the IABP driving device 10 shown in FIGS. It is a graph showing the relationship with the actual expansion volume of the balloon 92 after driving the balloon 92 in synchronization with the heart rate for 10 seconds. From FIG. 4, it can be understood that in the IABP drive device 10, the expanded volume is constant regardless of the heart rate in a region where the heart rate is lower than 120 bpm. That is, as shown by the internal pressure waveform 86 in FIG. 3, when the heart rate is lower than 120 bpm (80 bpm in the display of the blood pressure / heart rate display unit 64b), the positive pressure side solenoid valve 28 shown in FIG. The cycle of moving the diaphragm 26 of the pressure bulkhead device 25 by the pressure of the positive pressure tank 31 is longer than when the heart rate is higher (for example, the heart rate is 120 bpm or more).

  Therefore, the pump 30 shown in FIG. 2 can recover the pressure PT1 of the positive pressure tank 31 reduced by moving the diaphragm 26 to the set value before the next positive pressure solenoid valve 28 is opened. it can. In other words, in a region where the heart rate is lower than 120 bpm, the pressure of the positive pressure tank 31 at the time of switching the positive pressure side solenoid valve 28 from the closed state to the open state is constant regardless of the heart rate, so that the balloon 92 The expansion volume is constant as shown in FIG.

  Further, the volume (chemical equivalent) of the shuttle gas filled in the secondary piping system 21b of the IABP driving device 10 and the balloon catheter 90 is set to an amount that can normally completely expand the balloon 92. Therefore, in a region where the heart rate is lower than 120 bpm, the balloon 92 connected to the IABP driving device 10 is completely expanded each time the balloon is expanded, so that the state where the surface of the balloon 92 is uneven may be maintained for a long time. In other words, it can be said that there is no problem that a blood clot is formed due to the stagnation of blood on the irregularities. The state where the balloon 92 is completely expanded means that the balloon 92 is expanded to a predetermined volume and the surface of the balloon 92 is substantially free of irregularities. The volume of the balloon 92 is determined by selecting the size of the balloon 92 to be used in advance according to the patient's physique and the like, and is selected, for example, in the range of 30 to 45 ml.

  On the other hand, in a region where the heart rate is 120 bpm or more, as shown in FIG. 4, the expanded volume of the balloon 92 decreases as the heart rate increases, and it can be understood that the balloon 92 cannot be completely expanded. . The left part of FIG. 5 shows the internal pressure waveform 88 in a state in which the IABP driving device 10 performs a high-speed continuous driving 93 for continuously driving the balloon 92 in synchronization with a heart rate having a heart rate of 120 bpm or more. Is represented. In the high-speed continuous drive 93, the cycle in which the positive pressure side solenoid valve 28 shown in FIG. 2 is opened and the diaphragm 26 of the pressure bulkhead device 25 is moved by the pressure of the positive pressure tank 31 when the heart rate falls below 120 bpm (FIG. (See internal pressure waveform 86).

  Therefore, the pump 30 shown in FIG. 2 can recover the pressure PT1 of the positive pressure tank 31 reduced by moving the diaphragm 26 to the set value before the next positive pressure solenoid valve 28 is opened. Can not. In other words, in the region where the heart rate is 120 bpm or more, the pressure of the positive pressure tank 31 at the time of switching the positive pressure side solenoid valve 28 from the closed state to the open state is the time spent for the recovery of the pressure of the positive pressure tank 31, That is, it depends on the heart rate that determines the time.

  Therefore, as shown in FIG. 4, as the heart rate increases and the time spent for restoring the pressure of the positive pressure tank 31 decreases, the expansion volume of the balloon 92 decreases, and the balloon 92 cannot be completely expanded. If the balloon 92 cannot be fully expanded, the film of the balloon 92 will always have slack, and a state where a dent has occurred in a part of the surface of the balloon 92 may be maintained. If such a state continues for a long time, there is a problem that blood stays in the dent and a thrombus is easily formed.

  However, even if the balloon 92 has not been completely inflated, if a predetermined pressure difference can be generated between the inflated balloon and the deflated balloon, such as when the internal pressure of the balloon is equal to or higher than the systolic pressure, the IABP drive The device 10 can generate a certain cardiac function assisting effect by driving the balloon 92.

  Therefore, when performing the high-speed continuous drive 93 for continuously driving the balloon 92 in synchronization with a heartbeat having a heart rate of 120 bpm or more, the control unit 62 illustrated in FIG. Then, the high-speed continuous driving 95 is performed again after performing the rest operation 94 shown in FIG. In the pause operation 94, the control unit 62 controls the balloon driving unit 20a shown in FIG. 2 so as to maintain the balloon 92 in the deflated state for a predetermined number of heartbeats.

  As shown in FIG. 5, when the balloon driving section 20a performs the resting operation 94, the pump 30 shown in FIG. 2 reduces the pressure PT1 of the positive pressure tank 31 reduced by moving the diaphragm 26 to reduce the heart rate. As in the case described above, it is possible to recover to the set value. Therefore, as shown in FIG. 5, in the expansion performed immediately after the pause operation 94, the pressure of the positive pressure tank 31 at the time of switching the positive pressure side solenoid valve 28 from the closed state to the open state is higher than that before the pause. As a result, the balloon 92 can be fully inflated, or can be inflated to a state close to full inflation compared to the last inflation.

  According to such an IABP driving device 10, the time during which the balloon 92 cannot be completely expanded is prevented from continuing beyond a predetermined time, and the problem that a thrombus is easily formed on the surface of the balloon 92 can be prevented. Further, the IABP driving device 10 prevents a problem that a thrombus is easily formed on the surface of the balloon 92, and thus a thrombus formed on the surface of the balloon 92 and then peeled off from the balloon 92 clogs peripheral blood vessels and the like. Can be prevented.

  FIG. 6 is an example of a control method in which the control unit 62 illustrated in FIG. 2 controls the balloon driving unit 20a, and is a flowchart illustrating an example of a method of driving the balloon 92 by the IABP driving device 10. In step S001 shown in FIG. 6, the control unit 62 of the IABP driving device 10 causes the balloon driving unit 20a to start driving the balloon 92. The control unit 62 controls the balloon driving unit 20a to expand and contract the balloon 92 in synchronization with the heartbeat, and the cardiac function assisting operation by the IABP driving device 10 is started. Further, when the driving of the balloon 92 is started, the control unit 62 starts a detection timer for measuring the duration of the high-speed continuous driving. It is assumed that the assist ratio representing the ratio between the number of times of heartbeats and the number of times of assisting cardiac function due to expansion and contraction of the balloon 92 is set to 1: 1.

  In step S002, the control unit 62 determines whether the heart rate is equal to or greater than 120 bpm. The heart rate is calculated by the control unit 62 based on a signal (heartbeat signal) selected from either the electrocardiogram signal or the blood pressure signal. If the heart rate is lower than 120 bpm, the process proceeds to step S005 to reset the detection timer for high-speed continuous driving (restarted from 0 second), and then returns to the operation of step S002.

  If the heart rate is equal to or greater than 120 bpm in step S002, the process proceeds to step S003. In step S003, the control unit 62 detects whether the balloon driving unit 20a is driving the balloon 92 in synchronization with the heartbeat of 120 bpm or more determined in step S002 continuously for one minute or more. . More specifically, the control unit 62 makes the determination in step S003 based on whether or not the value of the detection timer for high-speed continuous driving started at the start of driving is 1 minute or more. In step S003, if the value of the detection timer indicating the continuation time of the high-speed continuous driving is 1 minute or more, the process proceeds to step S004. If the value of the detection timer is less than 1 minute, the process returns to step S002.

  In step S004, the control unit 62 causes the heartbeat operation 94 to maintain the balloon 92 in the deflated state for one heartbeat. As a result, as shown in FIG. 5, after the high-speed continuous driving 93, the balloon driving unit 20a performs the resting operation 94 for one heartbeat, and then drives the balloon 92 again continuously in synchronization with the heartbeat. High-speed continuous drive 95 is performed.

  After step S004, the control unit 62 proceeds to step S005 to reset the high-speed continuous drive detection timer (restarted from 0 second), and then returns to the operation of step S002. As described above, according to the driving method shown in FIG. 6, when the balloon driving unit 20a drives the balloon 92 continuously in synchronization with the heartbeat of 120 bpm or more for one minute or more, the control unit 62 controls the balloon driving. By controlling the unit 20a to perform the resting operation 94 for one heartbeat, it is possible to prevent the high-speed continuous driving 93 from continuing for a long time. In addition, by performing the beat-reducing operation 94, as shown in FIG. 5, the expansion volume when the balloon 92 is expanded temporarily increases, and the balloon 92 can be completely expanded. Can be prevented from being easily formed.

  In the example shown in FIG. 6, as shown in step S003, the control unit 62 causes the balloon driving unit 20a to perform the pause operation 94 when the high-speed continuous driving 93 continues for 1 minute or more. The duration of the high-speed continuous drive for performing the above operation may be a time of 30 seconds or more, and it is particularly preferable to appropriately select and determine the duration from 1 to 3 minutes. If the timing of performing the pause operation 94 is too early, the frequency of the pause operation 94 becomes too high, and the cardiac function assisting effect by driving the balloon 92 may be weakened. Further, if the timing of performing the beat-reducing operation 94 is too late, there is a possibility that formation of a thrombus on the surface of the balloon 92 may not be properly prevented.

  The pause operation 94 (performed during the predetermined number of heartbeats) for a predetermined number of heartbeats is counted as one pause operation, and the frequency of the pause operation is 60 to 180. It is preferable to perform the process once during the process. If the ratio of the resting motion 94 is too large, the heart function assisting effect by driving the balloon 92 may be weakened. If the ratio of the resting motion 94 is too small, formation of a thrombus on the surface of the balloon 92 can be appropriately prevented. It may disappear.

  In addition, in the example illustrated in FIG. 6, as illustrated in step S <b> 002, when the heart rate is equal to or greater than 120 bpm, the control unit 62 determines that high-speed continuous driving that requires the resting operation 94 occurs. However, the threshold for the heart rate (the value of the heart rate determined in step S002) as to whether or not the resting operation 94 is required is not limited to 120 bpm, and is an arbitrary heart rate at which the balloon 92 may not be completely inflated. It can be a number. The threshold value for the heart rate indicating whether or not the resting operation 94 is required can be changed according to the performance of the pump 30 shown in FIG. 2 and can be selected in a range of, for example, 100 to 140 bpm. . Further, in the beat resting operation 94, the period during which the balloon 92 is maintained in the deflated state (the number of heartbeats performed while the balloon 92 is maintained in the deflated state) is not limited to one time, and the capacity of the pump 30 is not limited to one. May be set in a period necessary for restoring the pressure, for example, a period of one to three heartbeats is preferable. However, if the period of the resting motion 94 is too long, the cardiac function assisting effect by driving the balloon 92 may be weakened. Therefore, it is most preferable that the period is one heartbeat.

  FIG. 7 is a flowchart illustrating another example of a method of driving the balloon 92 by the control unit 62 illustrated in FIG. In the example illustrated in FIG. 7, the control unit 62 performs different controls on the balloon driving unit 20a according to the heart rate when the balloon 92 is driven.

  In step S102, the control unit 62 that has started driving the balloon 92 in step S101 of FIG. 7 determines whether the heart rate is equal to or greater than 120 bpm. When the heart rate is lower than 120 bpm, the process proceeds to step S104, and the control unit 62 controls the balloon driving unit 20a so as to perform “assist ratio 1: 1 driving”. When the heart rate is equal to or greater than 120 bpm, the balloon driving section 20a can continue to completely expand the balloon 92 even if the balloon 92 is driven continuously in synchronization with the heartbeat (see FIG. 5). Therefore, in the control in step S104 in which the heart rate falls below 120 bpm, the control unit 62 and the balloon driving unit 20a drive the balloon 92 so as to continuously synchronize with the heartbeat (assist ratio 1: 1), and make a pause. Operation 94 is not performed.

If the heart rate is equal to or greater than 120 bpm in step S102, the process proceeds to step S103, and the control unit 62 determines whether the heart rate is equal to or greater than 180 bpm. When the heart rate is equal to or higher than 120 bpm and is lower than 180 bpm, the process proceeds to step S105, and the control unit 62 controls the balloon driving unit 20a to perform “high-speed continuous driving + beat-stop operation”.

  When the heart rate is equal to or higher than 120 bpm and is lower than 180 bpm, the balloon driving unit 20a cannot continue to completely expand the balloon 92 when the high-speed continuous driving 93 shown in FIG. 5 is performed (see FIG. 4). Therefore, in the control in step S105 in which the heart rate is equal to or higher than 120 bpm and lower than 180 bpm, the control unit 62 and the balloon driving unit 20a perform one time after the high-speed continuous driving 93 for a predetermined time as described in the flowchart of FIG. The balloon 92 is driven so as to perform the beat resting operation 94 described above. By such driving, the IABP driving device 10 prevents the problem that a thrombus is formed on the surface of the balloon 92, and drives the balloon 92 in a state where the assist ratio is very close to 1: 1. An auxiliary operation can be performed.

  As shown in FIG. 7, when the heart rate is equal to or more than 180 bpm in step S103, the process proceeds to step S106, and the control unit 62 controls the balloon driving unit 20a so as to perform “assist ratio 1: 2 driving”. .

  As shown in FIG. 4, when the balloon driving unit 20a tries to drive the balloon 92 so as to continuously synchronize with a heart rate having a heart rate of 180 bpm or more, the expansion volume of the balloon 92 becomes larger in the full expansion. It is greatly reduced with respect to volume. Therefore, in the control in step S106 when the heart rate is 180 bpm or more, the control unit 62 and the balloon driving unit 20a perform a cardiac function assisting operation for expanding and deflating the balloon 92 and a pause for maintaining the balloon 92 in a deflated state. "Assist ratio 1: 2 drive", in which the operation is alternately performed for each heartbeat, is performed. As a result, although the number of times of assisting the cardiac function by the balloon 92 is reduced, the expanded volume of the balloon 92 at the time of expansion is increased, and the balloon 92 can be completely expanded. Therefore, the IABP driving device 10 can prevent a problem that a thrombus is formed on the surface of the balloon 92 and can perform an effective cardiac function assisting operation.

  By performing the control as shown in FIG. 7, the IABP drive device 10 effectively assists the cardiac function according to the heart rate of the patient, and the state in which the balloon 92 is not completely expanded continues for a predetermined time or more. This can prevent the problem that a thrombus is easily formed on the surface of the balloon 92.

  As described above, the IABP driving device 10 and the driving method of the balloon 92 using the IABP driving device 10 have been described with reference to the embodiment and the specific operation using the same. However, the present invention is limited to only the above-described embodiment. Not something. For example, in the IABP driving device 10, the configuration of the balloon driving unit 20a is not limited to the one shown in FIG. 2, and the balloon driving unit 20a can expand and contract the balloon 92 by applying a positive pressure and a negative pressure alternately to the piping system. Any configuration may be used. In the secondary piping system 21b shown in FIG. 2, the shuttle gas is discharged to the secondary piping system 21b or the shuttle gas is sucked from the secondary piping system 21b separately from the pump 30 connected to the primary piping system 21a. An auxiliary pressure generating means, which can be used, can be connected.

DESCRIPTION OF SYMBOLS 10 ... IABP drive device 20 ... Device main body 20a ... Balloon drive part 21a ... Primary piping system 21b ... Secondary piping system 22 ... Measuring part 24 ... Adjustment part 25 ... Pressure bulkhead device 26 ... Diaphragm 28 ... Positive pressure side solenoid valve 29 ... Negative Compression side solenoid valve 30 Pump 31 Positive pressure tank 32 Positive pressure regulating valve 35 Negative pressure tank 36 Negative pressure regulating valve PT1, PT2 Pressure 48 Monitor installation part 49 Caster 60 Monitor part 62 Control part 64 ... Display unit 64a Waveform display unit 64b Blood pressure / heart rate display unit 68 Operation signal input unit 68a Adjustment input unit 69 Heartbeat signal input unit 70 Pilot lamp 82 Electrocardiogram waveform 84 Blood pressure waveform 86, 88 Internal pressure Waveform 90: Balloon catheter 92: Balloon 93, 95 ... High-speed continuous drive 94: Resting motion

Claims (3)

A method of driving a balloon by an IABP driving device that attaches a balloon catheter to which a balloon is connected and expands and contracts the balloon,
When performing high-speed continuous driving for driving the balloon continuously in synchronization with a heart rate having a heart rate of 120 bpm or more, if the high-speed continuous driving continues for a predetermined time of 30 seconds or more, a predetermined number of heartbeats On the other hand, a balloon driving method characterized by performing the high-speed continuous driving again after performing a resting operation for maintaining the balloon in a deflated state. A method for driving a balloon according to claim 1,
The method of driving a balloon according to claim 1, wherein the heart beat operation is performed once every 60 to 180 times of the heartbeat. Attach a balloon catheter to which a balloon is connected, a balloon driving unit that drives the balloon by alternately applying positive pressure and negative pressure to a piping system that transmits pressure to the balloon,
A control unit that controls the balloon driving unit, so that a heartbeat signal that is a signal related to a heartbeat is input, so that the balloon expands and contracts in synchronization with a heartbeat.
When the balloon driving unit continuously drives the balloon in synchronization with the heartbeat for a predetermined time of 30 seconds or more while the heart rate is 120 bpm or more, the control unit controls the balloon for a predetermined number of heartbeats. An IABP driving device that controls the balloon driving unit so as to drive the balloon continuously again in synchronization with a heartbeat after performing a resting operation for maintaining the balloon in a deflated state.

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