JP7103339B2 - IABP drive - Google Patents

Description

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

In the IABP method, in order to obtain a sufficient assisting (reducing the burden on the heart) effect, it is necessary to expand and contract the balloon placed in the aorta at an appropriate timing for 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 patient's heartbeat 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).

Further, in the IABP drive device, the balloon is expanded and contracted by alternately applying positive pressure and 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 the pump, and the positive pressure and the negative pressure formed 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 in the IABP method is pre-populated in the drive device that drives the balloon. Normally, in the balloon drive device, 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 so that the balloon expands completely. , 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 assistive effect of the balloon on the cardiac function when the patient's cardiac function is restored. In such a case, the size of the balloon expansion 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 may be a case where the balloon is desired to be continuously driven in a state where the balloon is not completely expanded at the time of expansion. As an IABP drive device that can handle such cases, it is known that the balloon can be expanded smaller than in the case of full expansion by adjusting the amount or pressure of the shuttle gas sent to the balloon (for example). , Patent Document 2).

International Publication No. 2011/114779 Japanese Unexamined Patent Publication No. 5-192396

However, if the driving is continued in a state where the balloon is not completely expanded even at the time of expansion, the membrane of the balloon is always in a loosened state, so that the state where the balloon surface is uneven is maintained, and blood is collected in the recessed part. There is a problem that it stays for a long time and blood clots are easily formed.

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

In order to achieve the above object, the method for driving the balloon according to the present invention is:
A method of driving a balloon by an IABP driving device in which a balloon catheter to which a balloon is connected is attached and the balloon is driven so as to repeat expansion and contraction.
A detection step for detecting a first expansion drive in which the balloon is incompletely expanded during expansion,
When the first expansion drive continues for a predetermined time of 30 seconds or more, a second expansion drive is performed for a predetermined number of heartbeats to expand the balloon more than when the balloon is expanded in the first expansion drive. It has a process.

The method for driving the balloon according to the present invention detects the first expansion drive in which the balloon is incompletely expanded during expansion, and when the first expansion drive continues for a predetermined time of 30 seconds or more, the balloon is expanded during the first expansion drive. The second expansion drive is performed to expand the balloon more than the balloon. In the second expansion drive, the balloon expands completely, or the balloon expands to a state closer to full expansion as compared with the time of the immediately preceding expansion. Therefore, according to such a balloon driving method, the time during which the balloon cannot be fully expanded does not continue for more than a predetermined time, so that the problem of thrombus formation on the surface of the balloon can be prevented.

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

When the augmentation setting value is set below a predetermined threshold value, there is a high possibility that the balloon has not expanded sufficiently. Therefore, by detecting this, the first expansion drive can be appropriately detected. 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.

When the balloon exclusion pressure is not observed in the blood pressure waveform, it is highly possible that the balloon is not sufficiently expanded. Therefore, by detecting that the balloon exclusion pressure is not observed in the blood pressure waveform, the first expansion drive is appropriate. Can be detected.

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

In the second expansion drive, the shuttle gas for expanding the balloon expands the balloon in a state where the amount of the shuttle gas for expanding the balloon is larger than that at the time of 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 drive device has a balloon drive unit that drives the balloon by alternately applying positive pressure and negative pressure to the piping system that transmits pressure to the balloon.
The balloon drive unit has an auxiliary tank that communicates with the piping system and the inside, 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 auxiliary valve may be opened and closed to expand the balloon 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 keeping the auxiliary valve closed.

By changing the operation of the auxiliary valve when the balloon is expanded in 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, so that the condition of the patient can be adjusted. It is possible to suitably prevent the formation of thrombi while providing appropriate cardiac function assistance.

Further, the IABP drive device according to the present invention is
A balloon driving unit that drives the balloon by attaching a balloon catheter to which the balloon is connected and alternately applying positive pressure and negative pressure to the piping system that transmits pressure to the balloon.
A control unit that controls the balloon driving unit so that a heartbeat signal, which is a signal related to the heartbeat, is input and the balloon expands and contracts in synchronization with the heartbeat.
It has an incomplete expansion detection unit that detects a first expansion drive in which the balloon expands incompletely at the time of expansion.
When the first expansion drive, in which the balloon is incompletely expanded during expansion, continues for a predetermined time of 30 seconds or more, the control unit receives a predetermined number of heartbeats from the time when the balloon is expanded during the first expansion drive. Also controls the balloon drive unit so that the first expansion drive is performed again after the second expansion drive that greatly expands the balloon.

The control unit of the IABP drive device according to the present invention detects the first expansion drive in which the balloon is incompletely expanded, and when the first expansion drive continues for a predetermined time of 30 seconds or more, the first expansion drive with respect to the balloon drive unit is performed. The second expansion drive that expands the balloon more than the expansion drive is performed, and then the first expansion drive is performed again. In the second expansion drive, the balloon expands completely or expands to a state closer to full expansion compared to the time of the previous expansion, so that the time during which the balloon cannot fully expand may continue beyond a predetermined time. Since there is no such thing, the problem of blood clot formation on the surface of the balloon can be prevented. Further, the second expansion drive can be performed in accordance with 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, so that the first expansion is performed. It is not necessary to interrupt the assisting motion of the cardiac function between the switching between the driving and the second expansion driving, and the assisting effect on the patient's heart hardly fluctuates.

FIG. 1 is an overall external view of an IABP drive device according to an embodiment of the present invention. FIG. 2 is a block diagram showing a schematic structure of the IABP drive device shown in FIG. FIG. 3 is an external view of the monitor unit as viewed from the front. FIG. 4 is a conceptual diagram showing the flow of shuttle gas accompanying the operation of the auxiliary valve included in the IABP drive device. FIG. 5 is a conceptual diagram showing a change in the internal pressure waveform due to the operation of the auxiliary valve included in the IABP drive device. FIG. 6 is a flowchart showing an example of a balloon driving method performed by the IABP driving device shown in FIG. FIG. 7 is a flowchart showing an example of the detection operation of the first extended drive by the detection unit of the IABP drive device shown in FIG. FIG. 8 is a conceptual diagram showing the valve opening / closing timing and the internal pressure waveform in the balloon driving method performed by the detection unit of the IABP driving device shown in FIG.

Hereinafter, the IABP drive device according to the present invention will be described in detail based on the embodiments shown in the drawings.

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

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

The monitor unit 60 is attached to the device main body 20 via a monitor installation unit 48 provided on the upper surface of the device main body 20. The monitor unit 60 is removable from the device main body 20. However, the monitor unit 60 is connected to the device main body 20 via a cable or the like (not shown), and receives power from the device main body 20, transfers data to and from the device main body 20, and receives signals. I / O can be performed.

As shown in FIG. 2, a balloon driving unit 20a for expanding / contracting the balloon 92 is housed inside the apparatus main body 20. In the balloon driving unit 20a, a balloon catheter 90 to which the balloon 92 is connected is attached, and positive pressure and negative pressure are alternately applied to the secondary piping system 21b, which is a piping system for transmitting pressure to the balloon 92, to obtain a balloon. Drives 92.

The balloon drive unit 20a has a secondary piping system 21b communicating with the balloon catheter 90 and a primary piping system 21a communicating with the pump 30 as a primary side pressure generating means. The primary piping system 21a and the secondary piping system 21b are separated by a pressure transmission partition wall device 25 (isolator). The pressure transmission partition wall 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 drive unit 20a, the fluid inside each of the primary piping system 21a and the secondary piping system 21b cannot move, but the pressure (volume) of the primary piping system 21a due to the movement of the diaphragm 26. (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 sandwiching the primary piping system 21a determines the capacity (chemical equivalent) of the shuttle gas sealed in the secondary piping system 21b. It has the advantage that it is easy to control constantly and that the consumption of shuttle gas used in the secondary piping system 21b can be suppressed.

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

As shown in FIG. 2, a pump 30 is arranged 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 simultaneously generates positive pressure and negative pressure by driving, but a pump (compressor or the like) that generates positive pressure and a pump that generates negative pressure (compressor or the like) It may be configured separately from the vacuum pump, etc.).

The positive pressure tank 31 and the negative pressure tank 35 include a positive pressure adjusting valve 32 and a negative pressure adjusting valve 36 for selectively opening and closing the communication between the inside and the outside (atmosphere) of each of the tanks 31 and 35, and each tank. A pressure sensor for measuring the internal pressures of 31 and 35 is provided, and 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, but for example, the pressure PT1 of the positive pressure tank 31 is maintained at 300 mmHg (gauge pressure) and the pressure PT2 of the negative pressure tank 35 is maintained at −150 mmHg (gauge pressure). Is controlled by.

The positive pressure tank 31 and the negative pressure tank 35 are connected to the input end of the pressure transmission partition wall device 25 via the positive pressure side solenoid valve 28 and the negative pressure side solenoid valve 29, which are independently controlled to open and close, respectively. The balloon driving unit 20a can expand and contract the balloon 92 by switching the open / closed 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 21b is provided with a measuring unit 22 for measuring the internal pressure of the balloon, which is the internal pressure of the balloon 92, an adjusting unit 24 for adjusting the internal pressure of the balloon, and an auxiliary unit 40 for assisting the expansion and contraction of the balloon 92. .. The measuring unit 22 is composed of a pressure sensor or the like, and measures the pressure inside the balloon catheter 90 filled with shuttle gas. The internal pressure signal, which is a signal related to the balloon internal pressure measured by the measuring unit 22, is output to the control unit 62 of the monitor unit 60.

The adjusting unit 24 adjusts the amount of shuttle gas circulating in the secondary piping system 21b and the balloon catheter 90 in order to expand the balloon 92, and adjusts the internal pressure of the balloon. For example, the adjusting unit 24 supplies shuttle gas to the secondary piping system 21b or from the secondary piping system 21b when the augmentation setting value for setting the amount of shuttle gas that expands the balloon 92 is changed. By discharging the shuttle gas, the internal pressure of the balloon is adjusted by increasing or decreasing the reference pressure, which is the internal pressure of the balloon when the balloon 92 contracts.

The auxiliary portion 40 has 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 according to the pressure difference between the secondary piping system 21b and its internal pressure, or the secondary piping system 21b receives the shuttle gas inside the auxiliary tank 42. It is a tank that discharges a part of the tank, and is connected to the secondary piping system 21b via an auxiliary valve 41. The auxiliary valve 41 is provided at a connection portion between the secondary piping system 21b and the auxiliary tank 42, and is a solenoid valve that selectively opens and closes the communication between the auxiliary tank 42 and the secondary piping system 21b, and controls the auxiliary valve 41. The opening / closing operation is controlled by the unit 62 at a predetermined timing.

The auxiliary tank 42 may be connected to an adjusting means (not shown) for replenishing the auxiliary tank 42 with the shuttle gas and discharging the shuttle gas from the auxiliary tank 42. Further, the adjusting unit 24 for adjusting the internal pressure of the balloon may be connected to the secondary piping system 21b via the auxiliary unit 40.

The operation of the auxiliary valve 41 will be described with reference to FIGS. 4 and 5.
FIG. 4 is a conceptual diagram showing the flow of shuttle gas accompanying the operation of the auxiliary valve 41 included in the balloon drive unit 20a shown in FIG. The operation of the auxiliary valve 41 when expanding the balloon 92 is as follows. That is, when the control unit 62 shown in FIG. 2 opens the positive pressure side solenoid valve 28 and starts applying positive pressure into the secondary piping system 21b by the pressure transmission partition wall device 25 (when switching from negative pressure to positive pressure). ) To a predetermined time (for example, 95 msec), the positive pressure side solenoid valve 28 is closed. In parallel with this, the control unit 62 elapses a predetermined time (for example, 105 msec) from the time when the positive pressure is started to be applied into the secondary piping system 21b (the time when the negative pressure is switched to the positive pressure) (that is, the time). , Open the auxiliary valve 41 10 msec after closing the positive pressure side electromagnetic valve 28, and open the auxiliary valve 41 before the next switch (switch from positive pressure to negative pressure) (for example, 10 msec before the next switch). close up.

As shown in FIG. 4A, when the auxiliary valve 41 is opened while a positive pressure is applied to the secondary piping system 21b, a part of the shuttle gas in the secondary piping system 21b is released to the secondary piping system. According to the pressure difference between the 21b and the auxiliary tank 42, as shown by the arrow in the figure, the pressure in the auxiliary tank 42 is sucked, so that the pressure (plateau pressure) in the secondary piping system 21b is reduced to the auxiliary tank 42. It decreases by the amount of helium gas sucked by.

The operation of the auxiliary valve 41 when expanding the balloon 92 is as follows. That is, when the control unit 62 shown in FIG. 2 opens the negative pressure side solenoid valve 29 and starts applying negative pressure into the secondary piping system 21b by the pressure transmission partition wall device 25 (when switching from positive pressure to negative pressure). ) To a predetermined time (for example, 640 msec), the negative pressure side solenoid valve 29 is closed. In parallel with this, the control unit 62 uses the auxiliary valve after a predetermined time (for example, 130 msec) has elapsed from the time when the negative pressure is started to be applied into the secondary piping system 21b (when the positive pressure is switched to the negative pressure). The 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 while a negative pressure is applied to the secondary piping system 21b, a part (or all) of the helium gas in the auxiliary tank 42 is secondary. Depending on the pressure difference between the piping system 21b and the auxiliary tank 42, the gas is discharged into the secondary piping system 21b as shown by the arrow in the figure, so that the pressure (reference pressure) of the secondary piping system 21b is increased. , The amount of helium gas discharged from the auxiliary tank 42 increases.

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

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

When a positive pressure is applied to the secondary piping system 21b with the auxiliary valve 41 shown in FIG. 2 closed, the pressure in the secondary piping system 21b is as shown in the internal pressure waveform 186 of FIG. 5 (a). Overshoots the plateau pressure (pressure when the balloon 92 is fully expanded) P1 and then drops to the plateau pressure P1 to switch to the next (negative pressure). It becomes a substantially constant state until switching), and by switching to negative pressure, the pressure in the secondary piping system 21b drops, and the pressure in the secondary piping system 18 is the reference pressure (pressure when the balloon 92 is fully contracted). After overshooting from P2, the pressure rises to the reference pressure P2 and becomes a substantially constant state until the time of the next switching (switching to positive pressure), and these are sequentially repeated. As a result, the volume change as shown in (B1) of FIG. 5A occurs, the balloon 92 can be expanded and contracted according to the heartbeat, and the auxiliary operation of the heart function can be performed.

FIG. 5B shows the internal pressure waveform 286 of the secondary piping system 21b and the volume change (B2) of the balloon in the state where the auxiliary valve 41 is operated. In FIG. 5B, as described 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 41 is opened. The auxiliary valve 41 is closed at a predetermined timing when 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 a negative pressure is applied to the secondary piping system 21b, and then the auxiliary valve 41 is opened. 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 rises. After overshooting, the pressure starts to decrease, and when the balloon 92 is fully expanded (t1), the pressure in the secondary piping system 21b is reduced by opening the auxiliary valve 41, and the plateau pressure (when the balloon 92 is fully expanded). Pressure) drops to P3 and remains in a substantially constant state until the next switching (switching to negative pressure). By switching to negative pressure, the pressure in the secondary piping system 21b drops and rises after overshooting. When the balloon 92 is fully contracted (t2), the pressure in the secondary piping system 21b rises due to the opening of the auxiliary valve 41 to the reference pressure (pressure when the balloon 92 is fully contracted) P4. It rises and becomes a substantially constant state until the next switching (switching to positive pressure), and these are repeated in sequence. As a result, the volume change as shown by the reference numeral (B2) in the figure is generated, the balloon 92 can be expanded and contracted according to the heartbeat, and the auxiliary operation of the heart function can be performed.

As is clear from the comparison between FIGS. 5A and 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 time to reach the plateau pressure from the reference pressure can be shortened during expansion, while the time to reach the plateau pressure from the plateau pressure can be shortened during contraction, and therefore, the auxiliary valve 41 can be operated. Thereby, the IABP drive 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 heart rate signal input unit 69. .. As shown in FIG. 3, the display unit 64 is arranged in an area of about the upper half of the front surface of the monitor unit 60, and is composed of a display such as a liquid crystal display or an organic EL display.

The control unit 62 is composed of a microprocessor or the like, and controls the balloon drive unit 20a, the display unit 64, and other configurations included in the IABP drive device 10 by performing various arithmetic processes. As will be described later, a heartbeat signal, which is a signal related to the heartbeat, is input to the control unit 62 via the heartbeat signal input unit 69. Further, the control unit 62 controls the balloon drive 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 an abnormality that has occurred in the IABP driving device 10 by changing the lighting color and lighting / blinking. The lighting state of the pilot lamp 70 is controlled by the control unit 62.

As shown in FIGS. 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 arranged in the center of the display unit 64, and three waveforms are displayed side by side on the waveform display unit 64a in the order of the electrocardiogram waveform 82, the blood pressure waveform 84, and the internal pressure waveform 86. The electrocardiogram waveform 82 displays an electrocardiogram signal representing the electrical activity of the patient's heart. The electrocardiogram signal is acquired by the electrocardiograph via an electrode pad attached to the patient, 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 electrocardiogram signal input via the heartbeat signal input unit 69 on the waveform display unit 64a as the electrocardiogram waveform 82. The electrocardiogram signal may be acquired directly by the IABP drive device 10 itself by incorporating an electrocardiograph in the IABP drive device 10, or via an electrocardiograph (polygraph, bedside monitor, etc.) outside the IABP drive device 10. May be obtained indirectly.

The blood pressure waveform 84 is a display of a blood pressure signal representing a patient's blood pressure. The blood pressure signal is measured using a balloon catheter 90 or a pressure transducer attached to another catheter connected to an artery, and is input to the monitor unit 60 via the heart rate signal input unit 69 shown in FIG. .. The control unit 62 of the monitor unit 60 displays the blood pressure signal input via the heart rate signal input unit 69 on the waveform display unit 64a as the blood pressure waveform 84. The heartbeat signal can be arbitrarily selected and used from either an electrocardiogram signal or a blood pressure signal.

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

As shown in FIG. 3, a blood pressure / heart rate display unit 64b that numerically displays blood pressure and heart rate is arranged on the right side of the display unit 64. 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 above the blood pressure / heart rate display unit 64b. The heart rate is calculated by the control unit 62 based on the electrocardiogram signal, and the systolic pressure, the diastolic pressure, the average pressure, and the augmentation pressure are calculated based on the blood pressure signal.

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

In the present embodiment, the augmentation set value can be set in 10 steps from the minimum value "1" to the maximum value "10", and the larger the augmentation set value is, the more the secondary piping system 21b and the balloon catheter are set. The amount of shuttle gas circulating in 90 is increasing.

The incomplete expansion detection unit 65 shown in FIG. 2 detects the first expansion drive in which the balloon 92 is incompletely expanded at the time of expansion. Here, in the IABP drive device 10 of the present embodiment, if the augmentation set value is "10", which is the initial value, the secondary piping system except for a special case where the patient's heart rate is very fast. When a positive pressure is applied to 21b, 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 completely expanded.

However, in the IABP drive device 10, the balloon 92 does not completely expand even when a positive pressure is applied to the secondary piping system 21b by changing the augmentation setting value described above, and the balloon 92 does not expand completely when the balloon 92 expands. It is possible to carry out a first expansion drive that is incompletely expanded. Such a first expansion drive is performed when it is desired to weaken the assistive effect of the balloon 92 on the cardiac function according to the recovery state of the cardiac function of the patient. The state in which the balloon 92 is completely expanded means that the balloon 92 is expanded to a predetermined volume and the surface of the balloon 92 is substantially free of irregularities, and the balloon 92 is incompletely expanded. The state means a state in which the balloon 92 does not expand to a predetermined volume and the surface of the balloon 92 has irregularities even when the balloon 92 is expanded to the maximum volume in one expansion. do. 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 the like, and is selected in the range of, for example, 30 to 45 ml.

The incomplete expansion detection unit 65 shown in FIG. 2 is normally driven when the augmentation setting 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. It is detected that the balloon 92 is equal to or less than a preset threshold value (“5” in the present embodiment), which is estimated to be incompletely expanded at the time of expansion under the conditions, and the augmentation setting value is the predetermined value. When the balloon 92 is driven below the threshold value, it is determined that the first expansion drive is being performed by the balloon driving unit 20a. Further, 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. In the incomplete expansion detection unit 65, 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, the balloon exclusion pressure 84a is recognized in the blood pressure waveform 84. Judge that there is no.

In this way, the incomplete expansion detection unit 65 detects whether or not the balloon 92 is driven by the first expansion accompanied by incomplete expansion at the time of expansion from the augmentation set value and the blood pressure waveform 84, and obtains the result. Notify the control unit 62. The control unit 62 monitors the time during which the first expansion drive continues based on the detection result by the incomplete expansion detection unit 65. Further, when the first expansion drive continues for 1 minute or more, the control unit 62 performs the second expansion drive that greatly expands the balloon 92 with respect to a predetermined number of heartbeats, and then performs the first expansion drive again. In addition, the balloon drive unit 20a is controlled. In the second expansion drive, the number of times the balloon 92 is greatly expanded can be set arbitrarily, but is preferably 1 to 3 times, and more preferably 1 time.

The distinction between the control unit 62 and the incomplete extension detection unit 65 is for convenience of explaining the function, and the control unit 62 and the incomplete extension detection unit 65 are composed of one microprocessor or the like. It may be composed of a plurality of circuits or the like.

Hereinafter, the specific driving of the balloon 92 by the IABP driving device 10 shown in FIG. 2 will be described with reference to FIGS. 6 to 8. FIG. 6 is a flowchart showing an example of a control method in which the control unit 62 shown in FIG. 2 controls the balloon drive unit 20a, and an example of a method of driving the balloon 92 by the IABP drive device 10. In step S001 shown in FIG. 6, the control unit 62 of the IABP drive device 10 causes the balloon drive unit 20a to start driving the balloon 92. The control unit 62 controls the balloon drive unit 20a to expand and contract the balloon 92 in synchronization with the heartbeat, and the cardiac function assisting operation by the IABP drive device 10 is started. Further, when the balloon 92 is started to be driven, the control unit 62 starts a detection timer for measuring the duration of the first extended drive.

In step S002, the control unit 62 determines whether or not the balloon drive unit 20a is performing the first expansion drive in which the balloon 92 is incompletely expanded at the time of expansion. In step S002, the control unit 62 makes the above-mentioned 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 step by the incomplete expansion detection unit 65. In step S101 of FIG. 7, the incomplete expansion detection unit 65 starts a detection step of detecting whether or not the first expansion drive of the balloon 92 is being performed. The incomplete expansion detection unit 65 starts the detection step in response to a request from the control unit 62 or at a predetermined cycle.

In step S102 of FIG. 7, in the incomplete expansion detection unit 65, the systolic pressure (blood pressure value Sys) 84b calculated from the blood pressure signal is equal to or higher than the augmentation pressure (Aug) 84c calculated from the blood pressure signal. Judge whether or not. When the systolic pressure (blood pressure value Sys) 84b is equal to or higher than 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 informs the control unit 62 that the first expansion drive is currently being performed by the balloon drive unit 20a. On the contrary, 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.

In step S103 of FIG. 7, the incomplete expansion detection unit 65 determines whether or not the augmentation setting value for setting the amount of shuttle gas is “5” or less, which is set as a threshold value. When the augmentation set 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 contrary, when 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. Detects that it is not (or the balloon 92 is fully inflated when inflated). In step S105, the incomplete expansion detection unit 65 informs the control unit 62 that the first expansion drive is not currently 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 in which the balloon 92 is incompletely expanded at the time of expansion is performed, and after transmitting the detection result to the control unit 62. , The detection process is completed.

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

In step S002 shown in FIG. 6, if the control unit 62 determines that the first expansion drive is being performed based on the detection result of the incomplete expansion detection unit 65, the control unit 62 proceeds to step S003. In step S003, the control unit 62 detects whether the first extended drive by the balloon drive unit 20a continues for 1 minute or more. More specifically, the control unit 62 determines 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 a second expansion drive that expands the balloon 92 more than the immediately preceding first expansion drive for one heartbeat. FIG. 8 shows the internal pressure waveform 386 and the valve in 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 / closed state.

In the first expansion drive 94 shown on the left side of FIG. 8, the control unit 62 closes the negative pressure side solenoid valve 29 and simultaneously closes the positive 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 solenoid valve 28 is opened, and the positive pressure side solenoid valve 28 is closed after a predetermined time (for example, 105 msec) has elapsed from the time when the positive pressure is started to be applied into the secondary piping system 21b. Further, as can be understood from the open / closed state of the positive pressure side solenoid valve 28, the negative pressure side solenoid valve 29, and the auxiliary valve 41, the control unit 62 has a predetermined time (from the time when the positive pressure is applied into the secondary piping system 21b). For example, after 95 msec) (that is, 10 msec after closing the positive pressure side solenoid valve 28), the auxiliary valve 41 is opened, and before the next switch (for example, 10 msec before the next switch), the auxiliary valve 41 is closed. ..

In the first expansion drive 94, when the balloon 92 is expanded, a part of the shuttle gas is released as shown in FIG. 4A by operating the auxiliary valve 41 provided in the secondary piping system 21b continuous with the balloon 92. It flows into the auxiliary tank 42. Since the plateau pressure P5 in the internal pressure waveform 386 of the balloon 92 shown in FIG. 8 drops due to the inflow of the shuttle gas into the auxiliary tank 42, 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 of. The opening / closing operation of the auxiliary valve 61 described here as in the first expansion drive 94 is also performed in a normal drive when the balloon 92 is completely expanded at the time of expansion.

On the other hand, in the second expansion drive 95 shown on the right side of FIG. 8, the control unit 62 closes the negative pressure side solenoid valve 29 and opens the positive pressure side solenoid valve 28 at the same time as in the case of the first expansion drive 94. The positive pressure side solenoid valve 28 is closed after a predetermined time (for example, 105 msec) has elapsed from the time when the positive pressure is started to be applied to 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 into the secondary piping system 21b. The auxiliary valve 41 is maintained in the closed state from the time when the operation is started to the next switching (that is, the time when the negative pressure side solenoid valve 29 is opened).

In the second expansion drive 95, by keeping the auxiliary valve 41 in the closed state and expanding the balloon 92, the shuttle gas does not flow into the auxiliary tank 42 as shown in FIG. 4A. 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 on the left side of FIG. Therefore, in the second expansion drive 95, the plateau pressure P7 in the internal pressure waveform 386 of the balloon 92 rises from the plateau pressure P5 of the first expansion drive 94, and the balloon 92 is completely expanded, or at least immediately before the first expansion drive. It expands to a state close to full expansion compared to the expansion by 94.

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 of the first expansion drive. After (restarting from 0 seconds), the operation returns to the operation of step S002.

As described above, in the drive method shown in FIG. 6, when the first expansion drive 94 continues for 1 minute or more, 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. Further, since the balloon 92 can be completely expanded or the balloon 92 can be expanded to a state close to the complete expansion by the second expansion drive 95, the 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 1 minute or more. The duration of the first extended drive 94 for performing the two extended drive 95 is not limited to one minute, and may be selected from any time of 30 seconds or more, preferably about 1 to 3 minutes, for example. If the timing at which the second extended drive 95 is performed is earlier than this, the cardiac function assisting effect of the IABP drive device 10 becomes too strong as intended, and there is a risk that problems such as the inability to perform the intended Wiing or the like may occur. Further, if the timing of performing the second expansion drive 95 is too late, the formation of a thrombus on the surface of the balloon 92 may not be properly prevented.

By performing the control as shown in FIG. 6, the IABP driving device 10 appropriately assists the cardiac function according to the patient's condition, and the balloon 92 does not fully expand for a predetermined time or longer. This can prevent the problem of thrombus formation on the surface of the balloon 92.

As described above, the IABP driving device 10 and the method of driving the balloon 92 by the IABP driving device 10 have been described with reference to the embodiment and the specific operation using the embodiment, but the present invention is limited to the above-described embodiment. It's not a thing. For example, in the IABP drive device 10, the configuration of the balloon drive unit 20a is not limited to that shown in FIG. 2, and the balloon 92 can be expanded / contracted by alternately applying positive pressure and negative pressure to the piping system. If there is, any configuration may be used.

Further, as the incomplete expansion detection unit 65 for detecting the first expansion drive 94 shown in FIG. 2, one that detects that the augmentation set value is equal to or less than a predetermined threshold value, or balloon exclusion in the blood pressure waveform 84. Not limited to those that detect that the pressure 84a is no longer recognized, for example, those that detect that the heart rate exceeds a predetermined value (for example, 120 bpm), for the first expansion drive in which the balloon is incompletely expanded at the time of expansion. The first extended drive may be detected based on information such as other related set values and signals. The detection of the first expansion drive does not mean only the one that directly detects the incomplete expansion at the time of expansion of the balloon, but the balloon 92 is incompletely expanded at the time of expansion based on the related information. It is a concept that also includes presuming that there is.

10 ... IABP drive device 20 ... Device body 20a ... Balloon drive unit 21a ... Primary piping system 21b ... Secondary piping system (piping system)
22 ... Measuring unit 24 ... Adjusting unit 25 ... Pressure transmission partition wall device 26 ... Diaphragm 28 ... Positive pressure side electromagnetic valve 29 ... Negative pressure side electromagnetic valve 30 ... Pump 31 ... Positive pressure tank 32 ... Positive pressure adjusting valve 35 ... Negative pressure tank 36 ... Negative pressure adjustment 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 Part 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 ... Contraction pressure 84c ... Augmentation pressure 86, 88, 186, 286, 386 ... Internal pressure waveform 90 ... Balloon catheter 92 ... Balloon 94 ... First expansion drive 95 ... Second expansion drive

Claims (4)

A balloon driving unit that drives the balloon by attaching a balloon catheter to which the balloon is connected and alternately applying positive pressure and negative pressure to the piping system that transmits pressure to the balloon.
A control unit that controls the balloon driving unit so that a heartbeat signal, which is a signal related to the heartbeat, is input and the balloon expands and contracts in synchronization with the heartbeat.
An incomplete expansion detection unit that detects the first expansion drive in which the balloon expands incompletely when expanded,
It has a setting value input unit for inputting an augmentation setting value for setting the amount of shuttle gas for expanding the balloon .
The incomplete expansion detection unit detects the first expansion drive when the augmentation setting value is set to be equal to or lower than a predetermined threshold value.
Based on the detection result of the incomplete expansion detection unit , the control unit detects that the first expansion drive has continued for a predetermined time of 30 seconds or more, and the control unit receives the first expansion drive for a predetermined number of heartbeats. An IABP drive device that controls the balloon drive unit so as to perform the first expansion drive again after performing the second expansion drive that expands the balloon more than when the balloon is expanded in one expansion drive. The IABP drive device according to claim 1.
The incomplete expansion detection unit further detects the first expansion drive even when the systolic pressure calculated from the blood pressure signal indicating the patient's blood pressure is equal to or higher than the augmentation pressure calculated from the blood pressure signal. IABP drive device. The IABP drive device according to claim 1 or 2.
In the second expansion drive, the control unit expands the balloon in a state where there is more shuttle gas to expand the balloon than when the balloon is expanded in the first expansion drive. IABP drive device that controls. The IABP drive device according to any one of claims 1 to 3.
The balloon drive unit has an auxiliary tank that communicates with the piping system and the inside, 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 control unit opens and closes 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, and expands the balloon. 2 In the expansion drive, an IABP drive device that controls the balloon drive unit so as to maintain the auxiliary valve in a closed state and expand the balloon.

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