WO2018159501A1

WO2018159501A1 - Drive method of balloon with iabp drive device, and iabp drive device

Info

Publication number: WO2018159501A1
Application number: PCT/JP2018/006780
Authority: WO
Inventors: 秀洋黒木
Original assignee: 日本ゼオン株式会社
Priority date: 2017-03-01
Filing date: 2018-02-23
Publication date: 2018-09-07
Also published as: JPWO2018159501A1; JP6958612B2

Abstract

[Problem] To provide a balloon drive method that uses an IABP drive device that can prevent the formation of thrombi on the balloon surface. [Solution] In this method of driving a balloon with an IABP drive device which is mounted with a balloon catheter with a balloon connected thereto and which expands and contracts the balloon. When driving a balloon continuously at high speed synchronized continuously to a heartbeat that is greater than or equal to 120 bpm, if this high-speed continuous driving continues for a prescribed time interval of at least 30 seconds, then, after a rest operation for maintaining the balloon in a contracted state for a prescribed number of heartbeats, the high-speed continued driving is continued again.

Description

Balloon driving method by IABP driving device and IABP driving device

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

In the IABP method, in order to obtain a sufficient assisting effect (reducing the burden on the heart), it is necessary to expand and contract the balloon placed in the aorta at an appropriate timing with respect to the heartbeat of the patient. Therefore, in the driving device that drives the balloon of the balloon catheter in the IABP method, a signal related to the heartbeat of the 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 per unit time of the operation of expanding and contracting the balloon increases as the patient's heart rate increases, and decreases as the patient's heart rate decreases (see Patent Document 1). .

Also, in the IABP drive device, the balloon is expanded and contracted by alternately applying a positive pressure and a negative pressure to the piping system that transmits the pressure to the balloon. Here, the positive pressure and the negative pressure applied to the piping system are formed 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 in each positive pressure / negative pressure tank is temporarily reduced or increased by applying a positive pressure or negative pressure to the piping system that transmits the pressure to the balloon, but is pressurized or reduced by the pump. The pressure before the pressure is transmitted to the balloon is returned to.

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

International Publication No. 2011/111479

However, when the pressure applied to the balloon by the IABP driving device decreases as the heart rate increases, the balloon cannot be completely expanded even when it is inflated, so that a thrombus is easily formed on the surface of the balloon. There is a risk of becoming. For example, if the balloon does not fully expand even during expansion and the balloon membrane is always in a loose state, the balloon surface will remain uneven, and blood will stay in the dent for a long time, causing thrombus. There arises a problem that is easily formed. In patients with reduced cardiac function to which the IABP method is applied, since tachycardia and arrhythmia are common, the balloon is often driven in synchronization with a heart rate with a high heart rate. It is desirable to avoid.

The present invention is made in view of such a situation, and relates to a balloon driving method and an IABP driving device by an IABP driving device that can prevent formation of a thrombus on the balloon surface.

In order to achieve the above object, a balloon driving method according to the present invention comprises:
A balloon driving method using an IABP driving device for attaching a balloon catheter to which a balloon is connected and expanding and contracting the balloon,
When performing high-speed continuous driving for driving the balloon in continuous 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 are generated. On the other hand, after performing a resting operation for maintaining the balloon in a deflated state, the high-speed continuous driving is performed again.

The balloon driving method according to the present invention detects a state in which a high-speed continuous drive in which the balloon may not be fully expanded continues for a predetermined time, and when this is detected, after performing a pause operation, the high-speed continuous drive is performed again. carry out. In the expansion performed immediately after the resting operation, a pressure similar to that during low-speed driving can be transmitted to the balloon, so that the balloon can be fully expanded or can be expanded to a state closer to full expansion compared to the previous expansion. Therefore, according to such a balloon driving method, the problem that thrombus is formed on the surface of the balloon can be prevented by preventing the time during which the balloon cannot be fully expanded from continuing beyond a predetermined time.

Also, for example, the resting operation may be performed at a rate of once during the heartbeat being performed 60 to 180 times.

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

Moreover, the IABP driving device according to the present invention is
A balloon driving unit that attaches a balloon catheter to which a balloon is connected and drives the balloon by alternately applying a positive pressure and a negative pressure to a piping system that transmits pressure to the balloon;
A heartbeat signal that is a signal related to a heartbeat, and a controller that controls the balloon driving unit so that the balloon expands and contracts in synchronization with the heartbeat, and
When the balloon driving unit continuously drives the balloon in synchronism with the heartbeat for a predetermined time of 30 seconds or more while the heart rate is 120 bpm or more, the controller controls the 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 in synchronization with a heartbeat again.

The control unit of the IABP drive device according to the present invention, when the balloon is driven for a predetermined time of 30 seconds or more under the condition that the balloon may not be fully expanded, makes a predetermined number of heartbeats with respect to the balloon drive unit. On the other hand, a resting operation for maintaining the balloon in a deflated state is performed. In the expansion performed immediately after the resting operation, the same pressure as that in the case of synchronizing with a slower heart rate can be transmitted to the balloon. Therefore, even if the balloon has not been fully expanded in the previous driving, the resting can be performed. One time immediately after the beat, it can be said that the balloon can be fully expanded or expanded to a state closer to complete expansion. Therefore, according to the IABP driving device having such a control unit, it is possible to prevent a thrombus from being formed on the surface of the balloon by preventing the time during which the balloon cannot be fully expanded from continuing beyond a predetermined time. Can be prevented.

FIG. 1 is an overall external view of an IABP driving apparatus 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 unit viewed from the front. FIG. 4 is a graph showing an example of the relationship between the balloon expansion capacity after 10 seconds of synchronous driving by the IABP driving apparatus shown in FIG. 1 and the synchronized heart rate. FIG. 5 is a graph showing an example of an internal pressure waveform of the 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 apparatus shown in FIG. FIG. 7 is a flowchart showing another example of a balloon driving method performed by the IABP driving apparatus shown in FIG.

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 apparatus 10 according to an embodiment of the present invention, and FIG. 2 is a block diagram showing a schematic structure of the IABP driving apparatus 10. As shown in FIG. 2, the IABP driving device 10 is a driving device used for attaching and deflating the balloon 92 by attaching an IABP balloon catheter 90 to which the balloon 92 is connected. The balloon catheter 90 is used by being attached to the apparatus main body 20 of the IABP driving apparatus 10 shown in FIG. A balloon 92 connected to the tip of the balloon catheter 90 is used by being placed in the descending aorta. The IABP driving device 10 can assist the blood circulation function of the heart by expanding and contracting the balloon 92 in accordance with the heartbeat.

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 are accommodated a balloon driving unit 20a for expanding and contracting the balloon 92, a power source unit (not shown) for supplying power to the expansion / contraction unit, and the like. A caster 49 is attached to the lower part of the apparatus main body 20, and the IABP driving apparatus 10 can be easily moved in a hospital or the like.

The monitor unit 60 is attached to the apparatus main body 20 via a monitor installation unit 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 unit 60 is connected to the apparatus main body 20 via a cable or the like (not shown), and receives power supply from the apparatus main body 20, exchanges data with the apparatus main body 20, I / O can be performed.

As shown in FIG. 2, a balloon driving unit 20a for expanding and contracting the balloon 92 is accommodated inside the apparatus main body 20. The balloon driving unit 20a includes a secondary piping system 21b that communicates with the balloon catheter 90 and a primary piping system 21a that communicates with a pump 30 as a primary pressure generating unit. The primary piping system 21a and the secondary piping system 21b are separated by a pressure partition device 25 (isolator). The pressure partition 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 fluids inside the primary piping system 21a and the secondary piping system 21b cannot move, but the diaphragm 26 moves to move the pressure (volume) of the primary piping system 21a. Change) is transmitted to the secondary piping system 21b.

As described above, the balloon drive unit 20a that arranges the primary piping system 21a and the secondary piping system 21b with the pressure bulkhead device 25 interposed therebetween has a constant capacity (chemical equivalent) of shuttle gas sealed in the secondary piping system 21b. It has the advantage that it is easy to control, and the consumption of the shuttle gas used in the secondary piping system 21b can be suppressed.

For example, air can be used as the internal fluid of the primary piping system 21a, and helium gas can be used as the internal fluid (shuttle gas) of the secondary piping system 21b. By making the internal fluid of the secondary piping system 21b helium gas having a small viscosity and mass, the response of expansion / contraction of the balloon 92 can be enhanced.

As shown in FIG. 2, a pump 30 is disposed in the primary piping system 21a. A positive pressure tank 31 is connected to the positive pressure output port of the pump 30, and a negative pressure tank 35 is connected to the negative pressure generation port of the pump 30. The pump 30 used in the present embodiment shown in FIG. 2 generates a positive pressure and a negative pressure simultaneously by driving. However, a pump (such as a compressor) that generates a positive pressure and a pump that generates a negative pressure (such as a compressor) You may comprise separately from a vacuum pump etc.).

The positive pressure tank 31 and the negative pressure tank 35 include a positive pressure adjustment valve 32 and a negative pressure adjustment valve 36 for selectively opening and closing communication between the inside of each

tank

31 and 35 and the outside (atmosphere), and each tank. The positive pressure tank 31 and the negative pressure tank 35 are controlled so as to have 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). 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 that are controlled to open and close independently. The balloon driving 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 circulates in the balloon catheter 90 and expands and contracts the balloon 92. The secondary piping system 21b is provided with a measuring unit 22 that measures the balloon internal pressure, which is the internal pressure of the balloon 92, and an adjusting unit 24 that adjusts the balloon internal pressure. The measurement unit 22 includes a pressure sensor or the like, and measures the pressure inside the balloon catheter 90 that is filled with the shuttle gas. An internal pressure signal that 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 adjusting unit 24 adjusts the amount of shuttle gas flowing through the secondary piping system 21b and the balloon catheter 90 in order to expand the balloon 92, thereby adjusting the balloon internal pressure. For example, the adjusting unit 24 increases the reference pressure that is the balloon internal pressure when the balloon 92 is deflated by supplying the shuttle gas to the secondary piping system 21b or discharging the shuttle gas from the secondary piping system 21b. Alternatively, the balloon internal pressure is adjusted by lowering.

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 heart rate signal input unit 69. As shown in FIG. 3, the display unit 64 is disposed in a region on the upper half of the front surface of the monitor unit 60 and is configured by a display 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 configurations 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 informs the operator of the driving state of the IABP driving device 10 including abnormality occurring in the IABP driving device 10 by changing the lighting color or lighting / flashing. The lighting state of the pilot lamp 70 is controlled by the control unit 62.

2 and 3, the display unit 64 includes a waveform display unit 64a and a blood pressure / heart rate display unit 64b. The waveform display unit 64a is disposed at the center of the display unit 64, and the waveform display unit 64a displays three waveforms side by side in the order of an electrocardiogram waveform 82, a blood pressure waveform 84, and an 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 through an electrode pad attached to the patient, and is input to the monitor unit 60 through 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 64 a as an electrocardiogram waveform 82. The electrocardiogram signal may be directly acquired by the IABP driving apparatus 10 itself by incorporating the electrocardiograph in the IABP driving apparatus 10 or via an electrocardiograph (polygraph, bedside monitor, etc.) outside the IABP driving apparatus 10. May be acquired indirectly.

The blood pressure waveform 84 displays a blood pressure signal representing 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 heartbeat signal input unit 69 as a blood pressure waveform 84 on the waveform display unit 64a.

The internal pressure waveform 86 displays an internal pressure signal representing the balloon internal pressure that is the internal pressure of the balloon 92. As shown in FIG. 2, the internal pressure signal is output from the measurement unit 22 provided in the secondary piping system 21 b in the apparatus 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 displaying the blood pressure and heart rate numerically is arranged. In the example shown in FIG. 3, the heart rate, systolic pressure, diastolic pressure, average pressure, and augmentation pressure are displayed in this order from the upper side of the blood pressure / heart rate display unit 64b. The heart rate is calculated based on the electrocardiogram signal, and the systolic pressure, diastolic pressure, average pressure, and augmentation pressure are calculated by the control unit 62 based on the blood pressure signal.

As shown in FIG. 3, the operation signal input unit 68 is disposed below the front surface of the monitor unit 60. The operator of the IABP driving device 10 can input various signals related to driving of the IABP driving device 10 such as the driving conditions of the balloon 92 and the 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, and shuttle gas that circulates in the secondary piping system 21 b and the balloon catheter 90. Increase or decrease the amount (chemical equivalent of helium gas) and adjust the balloon internal pressure.

FIG. 4 shows the synchronized heart rate when the balloon 92 having a volume (nominal volume) of 40 ml is expanded and contracted in synchronization with the heart rate 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 synchronizing with the heart rate for 10 seconds. From FIG. 4, it can be understood that in the IABP driving device 10, the expansion volume is constant regardless of the heart rate as long as the heart rate is below 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 electromagnetic valve 28 shown in FIG. The period in which the diaphragm 26 of the pressure partition device 25 is moved by the pressure of the positive pressure tank 31 is longer than that 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 that has been lowered by moving the diaphragm 26 to the set value until the positive pressure side electromagnetic valve 28 is next opened. it can. In other words, if the heart rate is below 120 bpm, the pressure in 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. 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 and the balloon catheter 90 of the IABP driving device 10 is normally set to an amount that allows the balloon 92 to be completely expanded. Therefore, in the region where the heart rate is less than 120 bpm, the balloon 92 connected to the IABP driving device 10 is completely expanded every time it is expanded, and therefore, the state in which 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 in that a thrombus is formed due to the accumulation of blood in the unevenness. The state in which the balloon 92 is fully 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 physique of the patient, and is selected in the range of, for example, 30 to 45 ml.

On the other hand, in the region where the heart rate is 120 bpm or more, as shown in FIG. 4, the expansion volume of the balloon 92 decreases as the heart rate increases, and it can be understood that the balloon 92 cannot be fully expanded. . The left part of FIG. 5 shows an internal pressure waveform 88 in a state where the IABP driving apparatus 10 performs high-speed continuous driving 93 that drives the balloon 92 in synchronization with a heart rate of 120 bpm or more. It represents. In the high-speed continuous drive 93, the positive pressure side solenoid valve 28 shown in FIG. 2 is opened, and the cycle of moving the diaphragm 26 of the pressure partition device 25 by the pressure of the positive pressure tank 31 is when the heart rate is less than 120 bpm (FIG. 3). Shorter than the internal pressure waveform 86).

Therefore, the pump 30 shown in FIG. 2 can recover the pressure PT1 of the positive pressure tank 31 that has been lowered by moving the diaphragm 26 to the set value until the positive pressure side electromagnetic valve 28 is next 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 electromagnetic valve 28 from the closed state to the open state is the time spent for 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 rises and the time spent recovering the pressure in the positive pressure tank 31 decreases, the expansion volume of the balloon 92 decreases and the balloon 92 cannot be fully expanded. When the balloon 92 cannot be fully expanded, the membrane of the balloon 92 will always have a slack, and a state in which 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, blood accumulates in the dent and a problem that a thrombus is easily formed occurs.

However, even if the balloon 92 has not been fully expanded, if a predetermined pressure difference can be generated between the balloon internal pressure during expansion and deflation, such as when the balloon internal pressure during expansion is greater than the systolic pressure, IABP driving The device 10 can generate a certain cardiac function assisting effect by driving the balloon 92.

Therefore, when the controller 62 shown in FIG. 2 performs the high-speed continuous drive 93 that continuously drives the balloon 92 in synchronization with the heart rate having a heart rate of 120 bpm or more, the high-speed continuous drive 93 continues for one minute or more. Then, after the pause operation 94 shown in FIG. 5 is performed, the high-speed continuous drive 95 is performed again. In the resting operation 94, the control unit 62 controls the balloon driving unit 20a shown in FIG. 2 so as to maintain the balloon 92 in a deflated state for a predetermined number of heartbeats.

As shown in FIG. 5, when the balloon driving unit 20a performs the resting operation 94, the pump 30 shown in FIG. 2 uses the pressure PT1 of the positive pressure tank 31 that is lowered by moving the diaphragm 26, and the heart rate is low. Similarly to the case, the set value can be recovered. Therefore, as shown in FIG. 5, in the expansion performed immediately after the resting 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 resting. As a result, the balloon 92 can be fully expanded, or can be expanded to a state close to full expansion as compared to the previous expansion.

Such an IABP driving device 10 prevents the time when the balloon 92 cannot be fully expanded from continuing beyond a predetermined time, and can prevent the problem that blood clots are easily formed on the surface of the balloon 92. Further, the IABP driving device 10 prevents the problem that blood clots are easily formed on the surface of the balloon 92, so that the blood clots that are formed on the surface of the balloon 92 and then peeled off from the balloon 92 clog the peripheral blood vessels. Can be prevented.

FIG. 6 is an example of a control method in which the control unit 62 shown in FIG. 2 controls the balloon driving unit 20a, and is a flowchart showing 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. In addition, when the driving of the balloon 92 is started, the control unit 62 starts a detection timer that measures the duration of the high-speed continuous driving. It is assumed that the assist ratio representing the ratio between the number of heartbeats and the number of cardiac function assisting operations by expansion / contraction of the balloon 92 is set to 1: 1.

In step S002, the control unit 62 determines whether or not the heart rate is 120 bpm or more. The heart rate is calculated by the control unit 62 based on a signal (heart rate signal) selected from either an electrocardiogram signal or a blood pressure signal. If the heart rate falls below 120 bpm, the process proceeds to step S005 to reset the high-speed continuous drive detection timer (restarted from 0 seconds), and then the process returns to step S002.

In step S002, when the heart rate is 120 bpm or more, the process proceeds to step S003. In step S003, the control unit 62 detects whether or not the balloon driving unit 20a is driving the balloon 92 in synchronization with the heart rate of 120 bpm or more determined in step S002 continuously for one minute or more. . More specifically, the control unit 62 performs the determination in step S003 depending on whether or not the value of the detection timer for the high-speed continuous drive started at the start of driving is 1 minute or more. In step S003, if the value of the detection timer indicating the duration of the high-speed continuous drive is 1 minute or more, the process proceeds to step S004, and 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 resting operation 94 to maintain the balloon 92 in a deflated state for one heartbeat. As a result, as shown in FIG. 5, the balloon driving unit 20a performs a resting operation 94 for one heartbeat after the high-speed continuous driving 93, and then drives the balloon 92 again in synchronization with the heartbeat again. High-speed continuous drive 95 is performed.

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

In the example illustrated in FIG. 6, as illustrated in step S <b> 003, the control unit 62 causes the balloon driving unit 20 a to perform a pause operation 94 when the high-speed continuous drive 93 continues for one minute or longer. The duration of the high-speed continuous drive for performing the above-mentioned process may be a time of 30 seconds or more, and it is preferable that the duration be selected appropriately from the range of 1 to 3 minutes. If the timing at which the rest operation 94 is performed is too early, the frequency of the rest operation 94 becomes too high, and the cardiac function assisting effect by driving the balloon 92 may be weakened. Moreover, if the timing for performing the resting operation 94 is too late, there is a possibility that formation of a thrombus on the surface of the balloon 92 cannot be prevented appropriately.

The resting operation 94 (performed during a predetermined number of heartbeats) for a predetermined number of heartbeats is counted as one resting operation, and the frequency at which the resting operation is performed is 60 to 180 for heartbeats. It is preferable to carry out at a rate of once during the round. If the rate of the resting action 94 is too large, the cardiac function assisting effect by driving the balloon 92 may be weakened. If the rate of the resting action 94 is too small, the formation of a thrombus on the surface of the balloon 92 can be appropriately prevented. There is a risk of disappearing.

In the example shown in FIG. 6, as shown in step S002, when the heart rate is 120 bpm or more, the control unit 62 determines that high-speed continuous driving that requires a resting operation 94 occurs. However, the threshold regarding the heart rate (whether the heart rate is determined in step S002) as to whether or not the resting operation 94 is necessary is not limited to 120 bpm, and any heart rate that may cause the balloon 92 to be not fully dilated. Can be a number. The threshold relating to the heart rate as to whether or not the resting operation 94 is necessary can be changed according to the capability of the pump 30 shown in FIG. 2, and can be selected in the range of 100 to 140 bpm, for example. . Further, in the 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, and the capacity of the pump 30 and the like Accordingly, it may be set in a period necessary for recovering the pressure, and for example, a period of 1 to 3 heartbeats is preferable. However, since the cardiac function assisting effect by driving the balloon 92 may be weakened if the period of the resting action 94 is too long, the period of one heartbeat is most preferable.

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

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

When the heart rate is 120 bpm or more in step S102, the process proceeds to step S103, and the control unit 62 determines whether or not the heart rate is 180 bpm or more. When the heart rate is 120 bpm or more and falls below 180 bpm, the process proceeds to step S105, and the control unit 62 controls the balloon driving unit 20a so as to perform “high-speed continuous driving + resting operation”.

When the heart rate is 120 bpm or more and lower than 180 bpm, the balloon drive unit 20a cannot continue to fully expand the balloon 92 when performing the high-speed continuous drive 93 as shown in FIG. 5 (see FIG. 4). Therefore, in the control of step S105 in which the heart rate is 120 bpm or more and falls below 180 bpm, the control unit 62 and the balloon drive unit 20a perform once after the high-speed continuous drive 93 for a predetermined time, as described in the flowchart of FIG. The balloon 92 is driven so as to perform the resting operation 94. By such driving, the IABP driving device 10 prevents the problem that 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, so that an effective cardiac function is achieved. An auxiliary operation can be performed.

As shown in FIG. 7, when the heart rate is 180 bpm or more in step S103, the process proceeds to step S106, and the control unit 62 controls the balloon driving unit 20a 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 is expanded in full expansion. It will decrease significantly with respect to volume. Therefore, in the control of 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 resting period for maintaining the balloon 92 in a deflated state. “Assist ratio 1: 2 drive” is performed in which the operation is alternately performed for each heartbeat. Thereby, although the number of cardiac function assisting operations by the balloon 92 decreases, the expansion volume of the balloon 92 at the time of expansion increases, and the balloon 92 can be fully expanded. Therefore, the IABP driving apparatus 10 can perform an effective cardiac function assisting operation while preventing the problem that a thrombus is formed on the surface of the balloon 92.

By performing the control as shown in FIG. 7, the IABP driving device 10 effectively assists the cardiac function according to the heart rate of the patient, and the state where the balloon 92 is not fully expanded continues for a predetermined time or more. This can prevent the problem that blood clots are likely to be formed on the surface of the balloon 92.

As described above, the IABP driving device 10 and the method for driving the balloon 92 using the IABP driving device 10 have been described with reference to the embodiments and specific operations using the embodiments. However, the present invention is limited only to the above-described embodiments. It is not a thing. For example, in the IABP driving device 10, the configuration of the balloon driving unit 20a is not limited to that shown in FIG. 2, and the balloon 92 can be expanded and contracted by alternately applying a positive pressure and a negative pressure to the piping system. Any configuration may be used. In the secondary piping system 21b shown in FIG. 2, apart from the pump 30 connected to the primary piping system 21a, the shuttle gas is discharged to the secondary piping system 21b, or the shuttle gas is sucked from the secondary piping system 21b. An auxiliary pressure generating means that can be connected may be connected.

DESCRIPTION OF SYMBOLS 10 ... IABP drive device 20 ... Apparatus main body 20a ... Balloon drive part 21a ... Primary piping system 21b ... Secondary piping system 22 ... Measurement part 24 ... Adjustment part 25 ... Pressure partition apparatus 26 ... Diaphragm 28 ... Positive pressure side solenoid valve 29 ... Yin Pressure side solenoid valve 30 ... Pump 31 ... Positive pressure tank 32 ... Positive pressure adjustment valve 35 ... Negative pressure tank 36 ... Negative pressure adjustment 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 Heart rate 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

A balloon driving method using an IABP driving device for attaching a balloon catheter to which a balloon is connected and expanding and contracting the balloon,
When performing high-speed continuous driving for driving the balloon in continuous 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 are generated. On the other hand, after performing a resting operation for maintaining the balloon in a deflated state, the high-speed continuous driving is performed again.
A balloon driving method according to claim 1, comprising:
The method of driving a balloon, wherein the resting operation is performed at a rate of once during 60 to 180 heartbeats.
A balloon driving unit that attaches a balloon catheter to which a balloon is connected and drives the balloon by alternately applying a positive pressure and a negative pressure to a piping system that transmits pressure to the balloon;
A heartbeat signal that is a signal related to a heartbeat, and a controller that controls the balloon driving unit so that the balloon expands and contracts in synchronization with the heartbeat, and
When the balloon driving unit continuously drives the balloon in synchronism with the heartbeat for a predetermined time of 30 seconds or more while the heart rate is 120 bpm or more, the controller controls the predetermined number of heartbeats. An IABP driving device that controls the balloon driving unit so as to drive the balloon in synchronization with a heartbeat again after performing a resting operation for maintaining the balloon in a deflated state.