WO2018159502A1

WO2018159502A1 - Drive method of balloon with iabp drive device, and iabp drive device

Info

Publication number: WO2018159502A1
Application number: PCT/JP2018/006782
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: JPWO2018159502A1; JP7103339B2

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 performs driving to repeat expansion and contraction of the balloon. This balloon drive method involves a detection step for detecting first expansion driving in which a balloon does not completely expand during expansion, and a step in which, when the first expansion driving has continued for a prescribed time interval of at least 30 seconds, second expansion driving is performed for expanding the balloon bigger than during the first expansion driving for a prescribed number of heartbeats.

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 (for example, patent Reference 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.

The volume of the balloon used for the IABP method is input in advance to a driving device that drives the balloon. Normally, the balloon drive device is configured so that when a positive pressure is applied to the piping system and the balloon expands, shuttle gas corresponding to the balloon volume input in advance flows into the balloon and the balloon is fully expanded. Adjust the amount of shuttle gas.

By the way, in the IABP method, there is a case where it is desired to gradually weaken the assisting effect of the cardiac function by the balloon when the patient's cardiac function is recovered. In such a case, the size of the balloon to be expanded is gradually reduced. In some cases, a so-called volume weaning method is used. Further, depending on the condition of the patient to which the IABP method is applied, there is a case where it is desired to continue driving the balloon while the balloon is not completely expanded at the time of expansion. As an IABP driving device that can cope with such cases, there is known an IABP driving device that can expand the balloon smaller than the case of full expansion by adjusting the amount or pressure of the shuttle gas fed into the balloon (for example, , See Patent Document 2).

International Publication No. 2011/111479 JP-A-5-192396

However, if the driving is continued in a state where the balloon is not completely expanded even at the time of expansion, since the balloon membrane is always in a loose state, the state in which the balloon surface has irregularities is maintained, and blood is retained in the recessed portion. The problem that it stays for a long time and thrombus tends to be formed arises.

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, wherein a balloon catheter to which a balloon is connected is attached, and the balloon is driven to repeat expansion and contraction.
Detecting a first expansion drive in which the balloon is incompletely expanded at the time of expansion;
When the first expansion drive continues for a predetermined time of 30 seconds or longer, a second expansion drive that expands the balloon to a greater extent than the time of expansion of the balloon in the first expansion drive is performed for a predetermined number of heartbeats. And a process.

According to the balloon driving method of the present invention, when the first expansion drive in which the balloon is incompletely expanded at the time of expansion is detected and the first expansion drive continues for a predetermined time of 30 seconds or more, the balloon is expanded at the first expansion drive. 2nd expansion drive which expands a balloon largely rather than is performed. In the second expansion drive, the balloon is fully expanded, or the balloon is expanded to a state closer to complete expansion compared to the previous expansion. Therefore, according to such a balloon driving method, the time during which the balloon cannot be completely expanded does not continue beyond a predetermined time, and therefore, a problem that thrombus is formed on the surface of the balloon can be prevented.

Also, for example, in the detection step, it may be detected that an augmentation set value for setting an amount of shuttle gas for expanding the balloon is set to a predetermined threshold value or less.

In a state where the augmentation setting value is set to a predetermined threshold value or less, there is a high possibility that the balloon is not sufficiently expanded, so that it is possible to appropriately detect the first expansion drive by detecting this. it can.

Further, for example, in the detection step, it may be detected that the balloon exclusion pressure is not recognized in the blood pressure waveform.

In the state where the balloon exclusion pressure is not recognized in the blood pressure waveform, there is a high possibility that the balloon is not sufficiently expanded. Therefore, the first expansion drive is appropriately performed by detecting that the balloon exclusion pressure is not recognized in the blood pressure waveform. Can be detected.

Also, for example, in the second expansion drive, the balloon may be expanded in a state where there is more shuttle gas for expanding the balloon than when the balloon is expanded in the first expansion drive.

In the second expansion drive, the balloon is expanded in a state where the shuttle gas for expanding the balloon is larger than that in the expansion of the balloon in the first expansion drive, so that the balloon is driven at the same timing as the first expansion drive. The balloon can be expanded more than the first expansion drive.

Further, for example, the IABP driving device has a balloon driving unit that drives the balloon by alternately applying a positive pressure and a negative pressure to a piping system that transmits the pressure to the balloon.
The balloon driving unit includes an auxiliary tank that communicates with the piping system and an auxiliary valve, and an auxiliary valve that is a valve that selectively opens and closes communication between the piping system and the auxiliary tank.
In the first expansion drive, the balloon may be expanded by opening and closing the auxiliary valve so as to reduce the pressure difference between the plateau pressure and the reference pressure in the internal pressure waveform of the balloon,
In the second expansion drive, the balloon may be expanded by maintaining the auxiliary valve in a closed state.

By changing the operation of the auxiliary valve during the expansion of the balloon between the first expansion drive and the second expansion drive, the balloon can be greatly expanded only in the second expansion drive that is temporarily performed. Thrombus formation can be suitably prevented while performing appropriate cardiac function support.

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 controller that controls the balloon driving unit so that a heartbeat signal that is a signal related to a heartbeat is input and the balloon is expanded and contracted in synchronization with the heartbeat;
An incomplete expansion detection unit for detecting a first expansion drive in which the balloon is incompletely expanded at the time of expansion;
When the first expansion drive in which the balloon is incompletely expanded at the time of expansion lasts for a predetermined time of 30 seconds or more, the control unit starts from the time of expansion of the balloon in the first expansion drive for a predetermined number of heartbeats. After the second expansion drive for greatly expanding the balloon, the balloon drive unit is controlled to perform the first expansion drive again.

The control unit of the IABP driving device according to the present invention detects the first expansion driving in which the balloon is incompletely expanded, and when the first expansion driving continues for a predetermined time of 30 seconds or more, the first driving is performed with respect to the balloon driving unit. The second expansion drive for expanding the balloon to a greater extent than the expansion drive is performed, and then the first expansion drive is performed again. In the second expansion drive, since the balloon is fully expanded, or the balloon expands to a state closer to the full expansion compared to the previous expansion, the time during which the balloon cannot be fully expanded may continue beyond a predetermined time. Therefore, the problem that thrombus is formed on the surface of the balloon can be prevented. In addition, the second expansion drive can be performed corresponding to the heartbeat cycle in the same manner as the first expansion drive, and the first expansion drive is performed again after the second expansion drive is performed. There is no need to interrupt the assisting function of the cardiac function between the drive and the second expansion drive, and there is little variation in the assist effect on the patient's heart.

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 conceptual diagram showing the circulation of shuttle gas accompanying the operation of the auxiliary valve included in the IABP driving device. FIG. 5 is a conceptual diagram showing changes in the internal pressure waveform accompanying the operation of the auxiliary valve included in the IABP driving device. 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 illustrating an example of the first extended drive detection operation by the detection unit of the IABP drive device illustrated in FIG. 1. FIG. 8 is a conceptual diagram showing valve opening / closing timings and internal pressure waveforms in the balloon driving method performed by the detection unit of the IABP driving device 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 apparatus 10 is a driving apparatus that is used to attach an IABP balloon catheter 90 to which a balloon 92 is connected, and to drive the balloon 92 so as to repeat expansion and contraction. 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 is attached with a balloon catheter 90 to which a balloon 92 is connected, and applies a positive pressure and a negative pressure alternately to the secondary piping system 21b, which is a piping system that transmits pressure to the balloon 92. 92 is driven.

The balloon drive unit 20a has a secondary piping system 21b that communicates with the balloon catheter 90 and a primary piping system 21a that communicates with the pump 30 as primary pressure generating means. The primary piping system 21a and the secondary piping system 21b are separated by a pressure transmission partition device 25 (isolator). The pressure transmission 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.

In this way, the balloon drive unit 20a that arranges the primary piping system 21a and the secondary piping system 21b with the pressure transmission partition wall device 25 interposed therebetween has the capacity (chemical equivalent) of the shuttle gas enclosed in the secondary piping system 21b. It has the advantage that it can be controlled to a certain level 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 generating 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 transmission partition 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 shuttle gas that circulates in the balloon catheter 90 and the secondary piping system 21b to expand and contract the balloon 92. The secondary piping system 21 b includes a measuring unit 22 that measures a balloon internal pressure that is an internal pressure of the balloon 92, an adjustment unit 24 that adjusts the balloon internal pressure, and an auxiliary unit 40 that assists the expansion and contraction of the balloon 92. . 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, when the augmentation set value for setting the amount of shuttle gas for expanding the balloon 92 is changed, the adjusting unit 24 supplies the shuttle gas to the secondary piping system 21b or from the secondary piping system 21b. By discharging the shuttle gas, the balloon internal pressure is adjusted by increasing or decreasing the reference pressure that is the balloon internal pressure when the balloon 92 is deflated.

The auxiliary unit 40 includes an auxiliary tank 42 and an auxiliary valve 41. The auxiliary tank 42 sucks a part of the shuttle gas in the secondary piping system 21b in accordance with the pressure difference between the secondary piping system 21b and its internal pressure, or causes the secondary piping system 21b to transfer the shuttle gas therein. This is a tank that discharges a part of the tank, and is connected to the secondary piping system 21 b via the auxiliary valve 41. The auxiliary valve 41 is an electromagnetic valve that is provided at a connection portion between the secondary piping system 21b and the auxiliary tank 42 and selectively opens and closes communication between the auxiliary tank 42 and the secondary piping system 21b. The opening / closing operation is controlled by the unit 62 at a predetermined timing.

It should be noted that the auxiliary tank 42 may be connected to an adjusting means (not shown) for replenishing the auxiliary tank 42 with shuttle gas or discharging the shuttle gas from the auxiliary tank 42. Moreover, the adjustment part 24 which adjusts a balloon internal pressure may be connected to the secondary piping system 21b via the auxiliary | assistant part 40. FIG.

The operation of the auxiliary valve 41 will be described with reference to FIGS.
FIG. 4 is a conceptual diagram showing the flow of shuttle gas accompanying the operation of the auxiliary valve 41 included in the balloon driving unit 20a shown in FIG. The operation of the auxiliary valve 41 when the balloon 92 is expanded is as follows. That is, the control unit 62 shown in FIG. 2 opens the positive pressure side electromagnetic valve 28 and starts applying positive pressure into the secondary piping system 21b by the pressure transmission partition device 25 (when switching from negative pressure to positive pressure). ), The positive pressure side solenoid valve 28 is closed after a predetermined time (for example, 95 msec) has elapsed. In parallel with this, the control unit 62 (for example, 105 msec) after the elapse of a predetermined time (for example, 105 msec) from the time when the application of the positive pressure into the secondary piping system 21b is started (ie, when the negative pressure is switched from the positive pressure). The auxiliary valve 41 is opened 10 msec after the positive pressure side solenoid valve 28 is closed) and the auxiliary valve 41 is set before the next switching (switching from positive pressure to negative pressure) (for example, 10 msec before the next switching). close.

As shown in FIG. 4A, when the auxiliary valve 41 is opened in a state where a positive pressure is applied to the secondary piping system 21b, a part of the shuttle gas in the secondary piping system 21b is converted into the secondary piping system 21b. Depending on the pressure difference between 21b and the auxiliary tank 42, as shown by the arrows in the figure, it is sucked into the auxiliary tank 42, whereby the pressure (plateau pressure) in the secondary piping system 21b is reduced to the auxiliary tank 42. Decreases by the amount of helium gas sucked by.

The operation of the auxiliary valve 41 when the balloon 92 is expanded is as follows. That is, the control unit 62 shown in FIG. 2 opens the negative pressure side electromagnetic valve 29 and starts applying negative pressure into the secondary piping system 21b by the pressure transmission partition device 25 (when switching from positive pressure to negative pressure). ) And the negative pressure side solenoid valve 29 is closed after a predetermined time (for example, 640 msec) has elapsed. In parallel with this, the control unit 62 sets the auxiliary valve after elapse of a predetermined time (for example, 130 msec) from the time when the application of the negative pressure into the secondary piping system 21b is started (the time when switching from the positive pressure to the negative pressure). 41 is opened, and the auxiliary valve 41 is closed before the next switching (switching from negative pressure to positive pressure) (for example, 10 msec before the next switching).

As shown in FIG. 4B, when the auxiliary valve 41 is opened in a state where negative pressure is applied to the secondary piping system 21b, a part (or all) of the helium gas in the auxiliary tank 42 becomes secondary. Depending on the pressure difference between the piping system 21b and the auxiliary tank 42, as shown by the arrows in the figure, the pressure is discharged into the secondary piping system 21b, whereby the pressure (reference pressure) of the secondary piping system 21b is reduced. The amount of helium gas discharged from the auxiliary tank 42 increases.

The timing for opening the auxiliary valve 41 (predetermined time from the time of switching from the positive pressure or the negative pressure to the negative pressure or the positive pressure) can be selected in accordance with the state of expansion or contraction of the balloon 92. For example, the balloon 92 can be set to be fully expanded or contracted. For this predetermined time (when the expansion or contraction is complete), positive pressure or negative pressure is experimentally applied to the balloon 92 using, for example, a water mock tester (for example, a back pressure of 70 mmHg, a gauge pressure). The volume change can be obtained by actual measurement.

FIG. 5 is a conceptual diagram showing changes in the internal pressure waveforms 186 and 286 with or without operation of the auxiliary valve 41. FIG. 5A shows the pressure waveform 186 of the secondary piping system 21b and the balloon volume change (B1) when the auxiliary valve 41 is not operated. In FIG. 5A, the auxiliary valve 41 is always kept closed.

In the state where the auxiliary valve 41 shown in FIG. 2 is closed, when a positive pressure is applied to the secondary piping system 21b, the pressure in the secondary piping system 21b is as shown by the internal pressure waveform 186 in FIG. The pressure in the secondary piping system 21b overshoots the plateau pressure (pressure when the balloon 92 is fully expanded) P1, then drops to the plateau pressure P1, and the next switching (to negative pressure) The pressure in the secondary piping system 21b is lowered by switching to the negative pressure, and the pressure in the secondary piping system 18 is the reference pressure (pressure when the balloon 92 is fully contracted). After overshooting more than P2, the pressure rises to the reference pressure P2 and becomes substantially constant until the next switching (switching to the positive pressure), and these are repeated sequentially. As a result, a volume change as shown in (B1) of FIG. 5A occurs, and the balloon 92 can be expanded and contracted in accordance with the pulsation of the heart, and an assisting operation of the cardiac function can be performed.

FIG. 5B shows the internal pressure waveform 286 of the secondary piping system 21b and the balloon volume change (B2) when the auxiliary valve 41 is operated. In FIG. 5B, as explained in FIG. 4A, the auxiliary valve 41 is opened at a predetermined timing (t1) when a positive pressure is applied to the secondary piping system 21b, and then the secondary valve The auxiliary valve 41 is closed at a predetermined timing when a positive pressure is applied to the piping system 21b. Further, in FIG. 5B, as described in FIG. 4B, the auxiliary valve 41 is opened at a predetermined timing (t2) when the negative pressure is applied to the secondary piping system 21b, and thereafter The auxiliary valve 41 is closed at a predetermined timing when a negative pressure is applied to the secondary piping system 21b.

In the state where the auxiliary valve 41 is operated, as shown in the internal pressure waveform 286 of FIG. 5B, when a positive pressure is applied to the secondary piping system 21b, the pressure in the secondary piping system 21b increases, When the balloon 92 is fully expanded after the overshoot (t1), the auxiliary valve 41 is opened to reduce the pressure in the secondary piping system 21b and the plateau pressure (when the balloon 92 is fully expanded). The pressure in the secondary piping system 21b drops and rises after overshooting due to the switching to the negative pressure. When the balloon 92 is fully contracted (t2), the auxiliary valve 41 is opened to increase the pressure in the secondary piping system 21b to increase the reference pressure (the pressure when the balloon 92 is fully contracted). ) Rose to P4, become substantially constant until the next change (switch to positive pressure) and repeats them sequentially. As a result, a volume change as indicated by reference numeral (B2) in the figure occurs, and the balloon 92 can be expanded and contracted in accordance with the pulsation of the heart, and the assisting operation of the cardiac function can be performed.

As is clear from a comparison between FIG. 5A and FIG. 5B, by operating the auxiliary valve 41, the plateau pressure decreases from P1 to P3, and the reference pressure increases from P2 to P4. is doing. Therefore, by operating the auxiliary valve 41, the difference between the plateau pressure and the reference pressure can be reduced. As a result, the arrival time from the reference pressure to the plateau pressure can be shortened during expansion, while the arrival time from the plateau pressure to the reference pressure can be shortened during contraction, and thus the auxiliary valve 41 can be operated. Thus, the IABP driving device 10 can improve the responsiveness of the balloon 92.

As shown in FIG. 2, the monitor unit 60 includes a control unit 62, a display unit 64, an incomplete expansion detection unit 65, 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 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. As will be described later, a heartbeat signal, which is a signal related to a heartbeat, is input to the control unit 62 via the heartbeat signal input unit 69. The control unit 62 controls the balloon driving unit 20a so that the balloon 92 expands and contracts in synchronization with the heartbeat. 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 heartbeat signal can be arbitrarily selected from either an electrocardiogram signal or a blood pressure signal.

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 a set value input unit 68a for inputting an augmentation set value for setting the amount of shuttle gas for expanding the balloon 92. When the operator of the IABP driving device 10 presses the push button of the set value input unit 68a, an operation signal for changing the augmentation set value and setting a new value is input to the monitor unit 60. When an operation signal for changing the augmentation set value and setting a new value 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 secondary piping system 21b and the balloon. The amount of shuttle gas flowing through the catheter 90 (chemical equivalent of helium gas) is increased or decreased, and the balloon internal pressure is adjusted.

In the present embodiment, the augmentation set value can be set in 10 stages from the minimum value “1” to the maximum value “10”, and the secondary piping system 21b and the balloon catheter are increased as the augmentation set value is increased. The amount of shuttle gas flowing in 90 is increased.

2 detects the first expansion drive in which the balloon 92 is incompletely expanded when the balloon 92 is expanded. Here, in the IABP driving device 10 of the present embodiment, if the augmentation setting value is “10” which is the initial value, the secondary piping system is used except in a special case where the heart rate of the patient is very fast. The amount of shuttle gas flowing in the secondary piping system 21b and the balloon catheter 90 is adjusted so that the balloon 92 can be fully expanded in a state where a positive pressure is applied to 21b.

However, in the IABP driving device 10, the balloon 92 is not completely expanded even when a positive pressure is applied to the secondary piping system 21b by changing the above-described augmentation setting value, and the balloon 92 is not expanded. It is possible to implement a first expansion drive that incompletely expands. Such first expansion drive is performed when it is desired to weaken the assisting effect of the cardiac function by the balloon 92 according to the recovery state of the cardiac function of the patient. The state in which the balloon 92 is fully expanded means that the balloon 92 has been expanded to a predetermined volume, and the surface of the balloon 92 is substantially free of irregularities, and the balloon 92 has been incompletely expanded. The state means a state in which the balloon 92 is not expanded to a predetermined volume and the surface of the balloon 92 is uneven even when the balloon 92 is expanded to the maximum volume during one expansion. To do. The volume of the balloon 92 is determined by selecting the size of the balloon 92 used in advance according to the patient's physique and the like, and is selected in the range of 30 to 45 ml, for example.

The incomplete expansion detection unit 65 shown in FIG. 2 performs normal driving when the augmentation set value for setting the amount of shuttle gas flowing in the secondary piping system 21b and the balloon catheter 90 is equal to or less than that value. Under the condition, it is estimated that the balloon 92 is incompletely expanded at the time of expansion, and is detected to be less than a preset threshold value (“5” in the present embodiment), and the augmentation setting value is the predetermined value. When the balloon 92 is driven below the threshold, it is determined that the first expansion drive is performed by the balloon drive unit 20a. Furthermore, the incomplete expansion detection unit 65 detects that the balloon exclusion pressure 84a is not recognized in the blood pressure waveform 84, and the balloon 92 is driven in a state where the balloon exclusion pressure 84a is not recognized in the blood pressure waveform 84. In this case, it is determined that the first expansion drive is performed by the balloon drive unit 20a. The incomplete expansion detection unit 65 recognizes the balloon exclusion pressure 84a in the blood pressure waveform 84 when the systolic pressure 84b in the blood pressure waveform 84 shown in FIG. 3 is equal to or higher than the augmentation pressure 84c in the blood pressure waveform 84. Judge that there is no.

As described above, the incomplete expansion detection unit 65 detects whether or not the balloon 92 is driven in the first expansion accompanied by incomplete expansion at the time of expansion from the augmentation set value and the blood pressure waveform 84, and the result is obtained. This is transmitted to the control unit 62. Based on the detection result by the incomplete extension detection unit 65, the control unit 62 monitors the time for which the first extension drive continues. Further, when the first expansion drive continues for one minute or longer, the control unit 62 performs the second expansion drive that greatly expands the balloon 92 for a predetermined number of heartbeats, and then performs the first expansion drive again. Next, the balloon driving unit 20a is controlled. In the second expansion drive, the number of times the balloon 92 is greatly expanded can be arbitrarily set, but is preferably 1 to 3 times, and more preferably 1 time.

Note that the distinction between the control unit 62 and the incomplete extension detection unit 65 is for convenience of explanation, and the control unit 62 and the incomplete extension detection unit 65 are configured by a single microprocessor or the like. It may be configured by a plurality of circuits.

Hereinafter, specific driving of the balloon 92 by the IABP driving apparatus 10 shown in FIG. 2 will be described with reference to FIGS. FIG. 6 is a flowchart illustrating an example of a control method in which the control unit 62 illustrated in FIG. 2 controls the balloon driving unit 20a, and 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 first expansion drive.

In step S002, the control unit 62 determines whether or not the balloon driving unit 20a is performing the first expansion driving in which the balloon 92 is incompletely expanded at the time of expansion. In step S002, the control unit 62 makes the above determination based on the detection result by the incomplete extension detection unit 65 shown in FIG. FIG. 7 is a flowchart showing an incomplete expansion detection process by the incomplete expansion detection unit 65. In step S101 in FIG. 7, the incomplete expansion detection unit 65 starts a detection process for detecting whether or not the first expansion drive of the balloon 92 is performed. The incomplete extension detection unit 65 starts the detection process in response to a request from the control unit 62 or at a predetermined cycle.

In step S102 of FIG. 7, the incomplete expansion detection unit 65 has a systolic pressure (blood pressure value Sys) 84b calculated from the blood pressure signal equal to or higher than an augmentation pressure (Aug) 84c calculated from the blood pressure signal. Determine whether or not. If the systolic pressure (blood pressure value Sys) 84b is greater than or equal to the augmentation pressure (Aug) 84c, the incomplete expansion detection unit 65 proceeds to step S104, and the balloon 92 is incompletely expanded at the time of expansion. Is detected. In step S104, the incomplete expansion detection unit 65 notifies the control unit 62 that the first expansion drive is currently being performed by the balloon drive unit 20a. On the other hand, when the systolic pressure (blood pressure value Sys) 84b is not equal to or higher than the augmentation pressure (Aug) 84c, the process proceeds to step S103.

7, the incomplete expansion detection unit 65 determines whether or not the augmentation set value for setting the amount of shuttle gas is equal to or less than “5” set as the threshold value. If the augmentation setting value is from “1” to “5”, the incomplete expansion detection unit 65 proceeds to step S104 and detects that the balloon 92 is incompletely expanded at the time of expansion. The operation in step S104 is as described above.

On the other hand, if the augmentation setting value is from “6” to “10”, the incomplete expansion detection unit 65 proceeds to step S105, and the balloon 92 is incompletely expanded at the time of expansion. It is detected that there is no (or the balloon 92 is fully expanded upon expansion). In step S105, the incomplete expansion detection unit 65 notifies the control unit 62 that the first expansion drive is not currently being performed by the balloon drive unit 20a.

As shown in FIG. 7, the incomplete expansion detection unit 65 detects whether or not the first expansion drive is performed in which the balloon 92 is incompletely expanded at the time of expansion, and the detection result is transmitted to the control unit 62. The detection process is terminated.

In step S002 shown in FIG. 6, when the control unit 62 determines that the first extension drive is not performed based on the detection result of the incomplete extension detection unit 65, the control unit 62 proceeds to step S005 and performs the first extension drive. After resetting the detection timer (restarting from 0 seconds), the process returns to the operation of step S002.

In step S002 shown in FIG. 6, when the control unit 62 determines that the first extension drive is being performed based on the detection result of the incomplete extension detection unit 65, the process proceeds to step S003. In step S003, the control unit 62 detects whether or not the first expansion drive by the balloon drive unit 20a continues for one minute or longer. More specifically, the control unit 62 performs the determination in step S003 depending on whether or not the value of the detection timer of the first extended 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 first extended 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 performs a step of performing the second expansion drive for expanding the balloon 92 larger than the immediately preceding first expansion drive for one heartbeat. FIG. 8 shows the internal pressure waveform 386 and the valve of the second expansion drive 95 implemented by the control unit 62 controlling the balloon drive unit 20a and the first expansion drive 94 performed immediately before the second expansion drive 95. It is a conceptual diagram showing an open / close state.

In the first extended drive 94 shown in the left part of FIG. 8, the control unit 62 closes the negative pressure side solenoid valve 29 and simultaneously closes the negative pressure side solenoid valve 29 so that it can be understood from the open / closed state of the positive pressure side solenoid valve 28 and the negative pressure side solenoid valve 29. The electromagnetic valve 28 is opened, and the positive pressure side electromagnetic valve 28 is closed after a predetermined time (for example, 105 msec) has elapsed since the start of application of positive pressure into the secondary piping system 21b. In addition, as can be understood from the open / closed states of the positive pressure side solenoid valve 28, the negative pressure side solenoid valve 29, and the auxiliary valve 41, the control unit 62 starts the application of positive pressure in the secondary piping system 21b for a predetermined time ( For example, the auxiliary valve 41 is opened after a lapse of 95 msec (that is, 10 msec after the positive pressure side solenoid valve 28 is closed), and the auxiliary valve 41 is closed before the next switching (for example, 10 msec before the next switching). .

In the first expansion drive 94, when the balloon 92 is expanded, by operating the auxiliary valve 41 provided in the secondary piping system 21b continuous to the balloon 92, a part of the shuttle gas is generated as shown in FIG. It flows into the auxiliary tank 42. The flow of the shuttle gas into the auxiliary tank 42 causes the plateau pressure P5 in the internal pressure waveform 386 of the balloon 92 shown in FIG. 8 to decrease, so that the auxiliary valve 41 has the plateau pressure P5 and the reference pressure P6 in the internal pressure waveform 386 of the balloon 92. Reduce the pressure difference. Note that the opening / closing operation of the auxiliary valve 61 described here as in the first expansion drive 94 is also performed in normal driving when the balloon 92 is fully expanded during expansion.

On the other hand, in the second expansion drive 95 shown in the right part of FIG. 8, the control unit 62 closes the negative pressure side electromagnetic valve 29 and simultaneously opens the positive pressure side electromagnetic valve 28, as in the case of the first expansion drive 94. The positive pressure side solenoid valve 28 is closed after elapse of a predetermined time (for example, 105 msec) from the time when application of the positive pressure is started in the next piping system 21b. However, as can be understood from the open / closed states of the positive pressure side solenoid valve 28, the negative pressure side solenoid valve 29, and the auxiliary valve 41, in the second expansion drive 95, the control unit 62 applies a positive pressure to the secondary piping system 21b. The auxiliary valve 41 is kept closed until the next switching (that is, the time when the negative pressure side electromagnetic valve 29 is opened) from the time when the operation is started.

In the second expansion drive 95, by keeping the auxiliary valve 41 closed and expanding the balloon 92, the shuttle gas does not flow into the auxiliary tank 42 as shown in FIG. Therefore, in the second expansion drive 95, the balloon 92 is expanded in a state where there is more shuttle gas for expanding the balloon 92 than in the first expansion drive 94 shown in the left part of FIG. Accordingly, in the second expansion drive 95, the plateau pressure P7 in the internal pressure waveform 386 of the balloon 92 increases from the plateau pressure P5 of the first expansion drive 94, and the balloon 92 is fully expanded or at least the immediately preceding first expansion drive. It expands to a state close to complete expansion as compared with 94 expansion.

As shown in FIG. 6, the control unit 62 causes the balloon drive unit 20a to perform the second expansion drive 95 as described above in step S004, and then proceeds to step S005 to reset the detection timer for the first expansion drive. After restarting from 0 seconds, the process returns to the operation of step S002.

Thus, in the driving method shown in FIG. 6, when the first expansion drive 94 continues for one minute or longer, the control unit 62 performs the second expansion drive 95 for one heartbeat on the balloon drive unit 20a. By controlling, it is possible to prevent the time during which the balloon cannot be fully expanded from continuing beyond a predetermined time. In addition, since the balloon 92 can be fully expanded by the second expansion drive 95, or the balloon 92 can be expanded to a state close to the complete expansion, a problem that a thrombus is formed on the surface of the balloon 92 can be prevented.

In the example shown in FIG. 6, as shown in step S003, the control unit 62 causes the balloon drive unit 20a to perform the second expansion drive 95 when the first expansion drive 94 continues for one minute or longer. The duration of the first extension drive 94 for performing the two extension drive 95 is not limited to one minute, and may be selected from an arbitrary time of 30 seconds or more, and is preferably about 1 to 3 minutes, for example. If the timing at which the second expansion drive 95 is performed is earlier than this, the cardiac function assisting effect by the IABP driving device 10 becomes too stronger than intended, and there is a possibility that problems such as inability to perform intended wings or the like may occur. In addition, if the timing for performing the second expansion drive 95 is too late, there is a possibility that formation of a thrombus on the surface of the balloon 92 cannot be prevented appropriately.

By performing the control as shown in FIG. 6, the IABP driving device 10 assists the cardiac function appropriately according to the patient's condition, and the state where the balloon 92 is not fully expanded continues for a predetermined time or more. It is possible to prevent the problem that thrombus is 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.

Further, the incomplete expansion detection unit 65 for detecting the first expansion drive 94 shown in FIG. 2 detects that the augmentation set value is equal to or less than a predetermined threshold, or eliminates the balloon in the blood pressure waveform 84. It is not limited to the one that detects that the pressure 84a is not recognized. For example, one that detects that the heart rate is equal to or higher than a predetermined value (for example, 120 bpm). The first extended drive may be detected based on information such as other related setting values and signals. The detection of the first expansion drive does not mean only detection of incomplete expansion when the balloon is expanded, but the balloon 92 is incompletely expanded during expansion based on related information. It is a concept that includes presuming that

DESCRIPTION OF SYMBOLS 10 ... IABP drive device 20 ... Apparatus main body 20a ... Balloon drive part 21a ... Primary piping system 21b ... Secondary piping system (pipe system)
DESCRIPTION OF SYMBOLS 22 ... Measuring part 24 ... Adjustment part 25 ... Pressure transmission partition apparatus 26 ... Diaphragm 28 ... Positive pressure side solenoid valve 29 ... Negative pressure side solenoid valve 30 ... Pump 31 ... Positive pressure tank 32 ... Positive pressure adjustment valve 35 ... Negative pressure tank 36 ... Negative pressure adjusting valve 40 ... auxiliary part 41 ... auxiliary valve 42 ... auxiliary tank PT1, PT2 ... pressure P5, P7 ... plateau pressure P6 ... reference 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 65 ... incomplete expansion detection unit 68 ... operation signal input unit 68a ... set value input unit 69 ... heart rate signal input unit 70 ... pilot lamp 82 ... electrocardiogram waveform 84 ... blood pressure Waveform 84a ... Balloon exclusion pressure 84b ... Systolic pressure 84c ...

Augmentation pressure

86, 88, 186, 286, 386 ... Internal pressure waveform 90 ... Rune catheter 92 ... balloon 94 ... first extended drive 95 ... second expanded drive

Claims

A balloon driving method using an IABP driving device, wherein a balloon catheter to which a balloon is connected is attached, and the balloon is driven to repeat expansion and contraction.
Detecting a first expansion drive in which the balloon is incompletely expanded at the time of expansion;
When the first expansion drive continues for a predetermined time of 30 seconds or more, performing a second expansion drive that expands the balloon larger than when the balloon is expanded in the first expansion drive;
A method of driving a balloon having
A balloon driving method according to claim 1, comprising:
In the detecting step, a balloon driving method for detecting that an augmentation set value for setting an amount of shuttle gas for expanding the balloon is set to a predetermined threshold value or less.
A balloon driving method according to claim 1, comprising:
In the detection step, a balloon driving method for detecting that no balloon exclusion pressure is recognized in the blood pressure waveform.
A balloon driving method according to any one of claims 1 to 3, comprising:
In the second expansion drive, the balloon is expanded in a state in which the amount of shuttle gas for expanding the balloon is larger than that during expansion of the balloon in the first expansion drive.
A balloon driving method according to any one of claims 1 to 4, comprising:
The IABP driving device includes a balloon driving unit that drives the balloon by alternately applying a positive pressure and a negative pressure to a piping system that transmits pressure to the balloon,
The balloon driving unit includes an auxiliary tank that communicates with the piping system and an auxiliary valve, and an auxiliary valve that is a valve that selectively opens and closes communication between the piping system and the auxiliary tank.
In the first expansion drive, the balloon is expanded by opening and closing the auxiliary valve so as to reduce the pressure difference between the plateau pressure and the reference pressure in the internal pressure waveform of the balloon,
In the second expansion drive, a balloon driving method in which the balloon is expanded by maintaining the auxiliary valve in a closed state.
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 controller that controls the balloon driving unit so that a heartbeat signal that is a signal related to a heartbeat is input and the balloon is expanded and contracted in synchronization with the heartbeat;
An incomplete expansion detection unit for detecting a first expansion drive in which the balloon is incompletely expanded at the time of expansion;
When the first expansion drive in which the balloon is incompletely expanded at the time of expansion lasts for a predetermined time of 30 seconds or more, the control unit starts from the time of expansion of the balloon in the first expansion drive for a predetermined number of heartbeats. An IABP driving device that controls the balloon driving unit so as to perform the first expansion driving again after performing the second expansion driving that greatly expands the balloon.