Medical expansion and contraction drive device

Abstract

To provide a medical expansion and contraction drive device capable of reducing a burden of a user without unnecessarily increasing a drive stop frequency, when a pressure abnormality in a piping system occurs.SOLUTION: A medical expansion and contraction drive device includes: a pressure transmission partition wall device 10 that controls inner gas in a gas pressure chamber 11 to flow in and out a balloon 110; a direction switching part 13 that changes a drive pressure Pi to increase an inner gas pressure from a side of a stable pressure (P1) after contraction of the balloon 110 at the time of flow-in operation and reduce the inner gas pressure from a side of a stable pressure (P4) after expansion of the balloon 110 at the time of flow-out operation; a gas adjustment part 59 that adjusts an inner gas pressure according to a communication state between the gas pressure chamber 11 and an auxiliary pressure chamber 41; and a pressure sensor 51 that detects an inner gas pressure. When it is determined as a pressure abnormality in a fluid connection line L2, abnormality release operation of increasing the inner gas pressure while blocking the auxiliary pressure chamber 41 from the gas pressure chamber 11 is performed. When the pressure abnormality is released, a measure of performing gas drive of the balloon 110 according to the drive pressure Pi is performed.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] The present invention relates to a medical inflation / deflation drive device, and more particularly to a medical inflation / deflation drive device suitable for driving a circulatory system function assisting device using an auxiliary circulation method (hereinafter referred to as an auxiliary circulation device). [Background technology]

[0002] A medical inflation / deflation driver that gas-drives a driven device capable of inflation / deflation is used in so-called auxiliary circulation devices, such as an intra-aortic balloon pump (IABP).

[0003] In such medical inflation / deflation drive devices, when an IABP balloon catheter is inserted through the femoral artery and the balloon is placed in the descending thoracic aorta, gas is driven to inflate and deflate the balloon in accordance with the beating of the heart, thereby assisting the function of the heart and reducing the burden on the patient, and it is required that the balloon be gas driven at the appropriate timing and pressure in relation to the inflation and deflation of the patient's heart.

[0004] A known example of this type of conventional medical inflation / deflation drive device includes a pressure generating means that is connected to the piping system of an IABP balloon catheter and applies positive and negative pressure alternately, an auxiliary tank that is connected to the piping system and draws in gas from or discharges gas to the piping system depending on the internal pressure difference, a valve means that is interposed between the auxiliary tank and the piping system, and a control means that controls the valve means in response to the application of pressure from the pressure generating means to the piping system.

[0005] In this medical inflation / deflation drive device, the valve means is opened after switching the applied pressure from the pressure generating means to the piping system, thereby reducing the pressure difference between the stable pressure after an overshoot when positive pressure is applied and the stable pressure after an undershoot when negative pressure is applied due to the increase in gas driving volume accompanying the connection of an auxiliary tank, and the valve means is closed before switching the next applied pressure, thereby increasing the gas driving speed of the balloon corresponding to the next switch in applied pressure due to the decrease in gas driving volume accompanying the blocking of the auxiliary tank, thereby ensuring the required responsiveness (see, for example, Patent Document 1).

[0006] In addition, this medical inflation / deflation drive device is further provided with a pressure sensor which detects the gas pressure in the piping system, a gas replenishment means which replenishes gas to the piping system via a gas tank when the pressure detected by the pressure sensor drops, and a gas leak warning means which outputs an alarm when it determines that a gas leak has occurred based on a change over time in the amount of gas replenished by the gas replenishment means. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] International Publication No. 2011 / 114779 Summary of the Invention [Problem to be solved by the invention]

[0008] In the above-mentioned conventional medical inflation / deflation drive device, by periodically visually checking the waveform (hereinafter sometimes referred to as the balloon internal pressure waveform) of the pressure in the piping system (generally referred to as the balloon internal pressure) displayed on the monitor while the balloon is being inflated / deflated, it is possible to determine the occurrence of some abnormality, such as insufficient balloon inflation or increased resistance to the movement of the internal gas in the catheter, according to changes in the pressure waveform. Moreover, since a gas leak warning means is provided that outputs a warning when a gas leak is detected, the occurrence of a gas leak abnormality that is difficult to determine from the displayed waveform can be accurately notified to the user.

[0009] Furthermore, in the conventional medical inflation / deflation drive device described above, if the device is configured to automatically determine that there is an abnormal condition and output an alarm when the internal gas pressure (hereinafter referred to as the plateau pressure) becomes higher than normal after the balloon has fully inflated and the internal balloon pressure waveform has overshot, or when the internal gas pressure (hereinafter referred to as the reference pressure) becomes lower than normal after the balloon has fully deflated and the internal balloon pressure waveform has undershot, it is believed that the occurrence of an abnormal pressure condition can also be reliably notified to the user.

[0010] However, if abnormality judgment is made uniformly based on the pressure detected by the pressure sensor that detects the gas pressure in the piping system, the medical inflation / deflation drive device must be stopped even in cases where the abnormal pressure state can be easily cleared by changing the position of the catheter, and the problem remains that the frequency of requests for action and judgment in response to alarms increases. Moreover, such problems can occur even if abnormality judgment is made by visual confirmation.

[0011] More specifically, for example, even under positive pressure application, the balloon may not be inflated sufficiently due to the balloon's placement in a tortuous blood vessel or the balloon may have a tendency to curl, or the gas passage may be narrowed due to the catheter being twisted, but the pressure inside the balloon catheter or piping system may be more likely to rise than usual, resulting in greater resistance to high-speed gas movement. In such cases, the abnormal pressure state may be easily eliminated by a slight change in the shape or position of the balloon catheter due to a change in internal pressure, and it is not appropriate to stop the gas drive of the driven device and require the user to take action or make a decision even in such a case, considering the burden on the patient and the burden on the user to operate the catheter.

[0012] The present invention has been made to solve these conventional problems, and aims to provide a medical inflation / deflation drive device that can reduce the burden on the user without unnecessarily increasing the frequency of drive stops when a pressure abnormality occurs in the piping system. [Means for solving the problem]

[0013] (1) In order to achieve the above object, the medical inflation / deflation drive device of the present invention comprises a gas operation section having a gas pressure chamber connected in communication with a driven device capable of inflation and deflation, and capable of moving gas in the gas pressure chamber in an inflow direction and an outflow direction relative to the driven device in response to an input driving pressure, a direction switching section which changes the driving pressure to switch the direction of the movement operation, and which increases the pressure of the gas pressure chamber from the stable pressure side after contraction in the driven device during the movement operation in the inflow direction, and decreases the pressure of the gas pressure chamber from the stable pressure side after expansion in the driven device during the movement operation in the outflow direction, a gas adjustment section having an auxiliary pressure chamber connected in communication with the gas pressure chamber in an interruptable manner, and which adjusts the pressure of the gas pressure chamber in response to a communication state between the gas pressure chamber and the auxiliary pressure chamber, and a pressure adjusting section which detects the pressure of the gas pressure chamber. a force detection unit, and a pressure determination unit which determines whether or not there is a pressure abnormality in the fluid connection line from inside the driven equipment to the gas pressure chamber based on detection information from the pressure detection unit, and an abnormality removal operation unit which, when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line, executes an abnormality removal operation to increase the pressure in the gas pressure chamber with the auxiliary pressure chamber disconnected from the gas pressure chamber, wherein, when the pressure abnormality is removed by the abnormality removal operation based on the determination result of the pressure determination unit, the device performs driving of the expansion and contraction of the driven equipment in response to the driving pressure input, and when the pressure abnormality is not removed even by the abnormality removal operation, the device stops driving of the expansion and contraction of the driven equipment in response to the driving pressure input.

[0014] With this configuration, in the present invention, when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line, the abnormality removal unit performs an abnormality removal operation in which the pressure in the gas pressure chamber is increased while the auxiliary pressure chamber is isolated from the gas pressure chamber. Then, when the pressure abnormality is removed by the abnormality removal operation, the expansion / contraction drive of the driven device according to the drive pressure input continues. Therefore, when a pressure abnormality occurs in the piping system, the frequency of drive stoppage is not unnecessarily increased, and the burden on the user due to drive stoppage can be effectively reduced.

[0015] (2) In a preferred embodiment of the present invention, the abnormality release operation unit has a post-contraction stable pressure measuring means for measuring the post-contraction stable pressure based on the detection information of the pressure detection unit while stopping the movement operation of the gas handling unit when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line based on the detection information of the pressure detection unit, and can be configured to perform the abnormality release operation while blocking the auxiliary pressure chamber from the gas pressure chamber when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line based on the detection information of the pressure detection unit and the pressure value measured by the post-contraction stable pressure measuring means falls within an allowable range for a preset reference pressure.

[0016] In this case, when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line, the gas movement operation for driving the driven device to expand and contract is stopped, and a check is made to see if the stable post-deflation pressure is within a tolerable range relative to a preset reference pressure, and when it is within the tolerable range, an abnormality release operation is performed to pressurize the gas pressure chamber with the auxiliary pressure chamber cut off from the gas pressure chamber. Therefore, the presence or absence of a pressure abnormality in the fluid connection line is accurately determined, and the abnormality release operation can be reliably performed when there is a high probability that the pressure abnormality will be released and there is no serious abnormality such as a gas leak or complete blockage of the fluid connection line.

[0017] (3) In a preferred embodiment of the present invention, when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line even after the abnormality removal operation unit has performed the abnormality removal operation a predetermined number of times, the device can be configured to have an alarm generating means that stops the expansion and contraction of the driven equipment in response to the driving pressure input and issues a predetermined alarm output.

[0018] With this configuration, when the pressure abnormality in the fluid connection line is not resolved by performing the abnormality removal operation a predetermined number of times, the expansion and contraction drive of the driven device according to the drive pressure input is stopped and a predetermined alarm is output. Therefore, the alarm output can notify the user of the drive stop state due to the occurrence of the abnormality, and it is possible to prompt the user to perform a more effective manual operation to remove the abnormality.

[0019] (4) In a preferred embodiment of the present invention, a drive start switch is provided for manually instructing the gas operation unit to start operation according to the drive pressure, and the abnormality release operation unit may be configured to operate again when the drive start switch is manually operated after the predetermined alarm is output by the alarm generation means and the pressure determination unit determines that there is an abnormal pressure in the fluid connection line continues. In this case, if the user takes action in response to the alarm output and the abnormal pressure state is resolved, normal drive is started in response to the manual operation of the drive start switch, while if the abnormal pressure state is not resolved, the abnormality release operation or further action by the user can be executed again.

[0020] (5) In a preferred embodiment of the present invention, the gas pressure chamber may further include exhaust means capable of exhausting the gas within the gas pressure chamber to the atmosphere, and gas replacement means for refilling the gas pressure chamber with new gas from the auxiliary pressure chamber side under a state in which the gas within the gas pressure chamber can be exhausted to the atmosphere by the exhaust means, and the abnormality release operation unit may be configured to execute the abnormality release in cooperation with the exhaust means and the gas replacement means.

[0021] With this configuration, while the gas in the gas pressure chamber and the driven device is exhausted to the atmosphere by the exhaust means, the gas replacement means replenishes new gas from the auxiliary pressure chamber side into the gas pressure chamber. This makes it possible to deal with deterioration of drive performance and responsiveness caused by leakage or contamination of the working gas used to drive the expansion and contraction of the driven device.

[0022] (6) In a preferred embodiment of the present invention, the driven equipment may be a device for auxiliary circulation. This configuration enables suitable inflation and deflation drive for the device for auxiliary circulation, such as a balloon catheter. The driven equipment may be a percutaneous ventricular assist device.

[0023] (7) In a preferred embodiment of the present invention, the gas handling unit has a movable pressure-receiving member that receives the driving pressure, and the pressure-receiving member can be configured to receive the driving pressure on one side and the gas pressure in the driven device and the gas pressure chamber on the other side. In this way, the gas handling unit can be configured simply. Effect of the Invention

[0024] According to the present invention, it is possible to provide a medical inflation / deflation drive device that can reduce the burden on the user without unnecessarily increasing the frequency of drive stops when a pressure abnormality occurs in the piping system. [Brief description of the drawings]

[0025] [Figure 1] FIG. 1 is an overall configuration diagram of a medical inflation / deflation drive device according to one embodiment of the present invention, showing a state in which an IABP balloon catheter is connected. [Diagram 2] FIG. 1 is a schematic diagram of an auxiliary device that exerts an acceleration function of the gas drive that inflates and deflates an IABP balloon catheter in a medical inflation / deflation drive device according to one embodiment of the present invention. [Diagram 3] 1 is a schematic cross-sectional view of a main portion of an IABP balloon catheter that can be used in a medical inflation / deflation drive device according to one embodiment of the present invention. [Figure 4] FIG. 2 is an explanatory diagram of the effect of driving the inflation and deflation of an IABP balloon catheter by the medical inflation and deflation drive device according to one embodiment of the present invention. [Diagram 5] 4 is a timing chart showing changes in balloon internal pressure and a procedure for adjusting the balloon internal pressure in a medical inflation / deflation drive device according to one embodiment of the present invention. [Figure 6] FIG. 1 is a functional explanatory diagram of an auxiliary device in a medical inflation / deflation drive device according to one embodiment of the present invention; (a) shows the changes in balloon internal pressure and balloon volume when the auxiliary device is not operated when inflating and deflating an IABP balloon catheter, for example during an abnormality release operation, and (b) shows the changes in balloon internal pressure and balloon volume during normal operation when the auxiliary device is operated when inflating and deflating an IABP balloon catheter. [Figure 7] 13 is a flowchart showing an abnormality handling procedure for performing an abnormality release operation or an alarm process when a pressure abnormality is detected in the medical expansion / deflation drive device according to one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] Hereinafter, an embodiment of the present invention will be described with reference to the drawings.

[0027] (One embodiment) 1 to 6 show the configuration of a medical inflation / deflation drive device according to one embodiment of the present invention, and illustrate the use of the present invention to drive the inflation and deflation of a balloon catheter for IABP (intra-aortic balloon pumping), which is an example of a driven device.

[0028] First, the configuration will be described.

[0029] As shown in Figures 1 and 2, the medical inflation / deflation drive device 1 of this embodiment has a pressure transmitting partition device 10 to which an IABP balloon catheter 100 (hereinafter simply referred to as the catheter 100) is detachably connected, and a pumping drive mechanism 13 that applies a drive pressure Pi, which alternates between positive pressure and negative pressure, to the primary side of the pressure transmitting partition device 10 by air pressure (fluid pressure).

[0030] The configuration of catheter 100 is substantially the same as that described in, for example, the aforementioned Patent Document 1. However, since the shape of balloon 110 before and after inflation is related to the pressure abnormality referred to in the present invention, the specific configuration of catheter 100 will be described first.

[0031] As shown in FIG. 3, the catheter 100 has an inflatable (expandable) and deflated balloon 110 (driven device) attached to the distal end of the catheter tube 124, and when the catheter 100 is inserted into a blood vessel, the balloon 110 is folded and wound around the outer periphery of the inner tube 130.

[0032] This catheter 100 is configured so that a small-diameter inner tube 130 is inserted into the catheter tube 124 to form a lumen for blood pressure measurement therein, and also forms a lumen for shuttle gas that moves the internal gas present in the catheter tube 124 outside the inner tube 130 back and forth in the directions of inflation and deflation of the balloon 110.

[0033] More specifically, the balloon 110 is made of a tubular balloon membrane having a thickness of, for example, about 50 to 150 μm, and the shape of the balloon 110 in the inflated state is, for example, a cylindrical shape or a polygonal cylindrical shape. The distal end of the balloon 110 is attached to the outer periphery of the distal end of the inner tube 130 by heat fusion or adhesion via the tip tip 125 or directly. The proximal end of the balloon 110 is joined to the distal end of the catheter tube 124 via a contrast marker such as a metal tube 127 or directly. The internal gas of the catheter 100 moves back and forth in the inflow and outflow directions with respect to the balloon 110, with a shuttle gas lumen formed inside the catheter tube 124 as the first lumen, so that the balloon 110 expands or contracts. The balloon 110 and the catheter tube 124 are joined to each other by, for example, heat fusion or an adhesive such as an ultraviolet curing resin.

[0034] The distal end of the inner tube 130 protrudes outward from the distal end of the catheter tube 124, and the proximal end of the inner tube 130 communicates with the second port 132 of the branched portion 126 on the proximal end side of the catheter 100. The lumen for measuring blood pressure inside the inner tube 130 is used as a second lumen, and the blood pressure on the side of the open end 23 of the distal end is transmitted from the second port 132 of the branched portion 126 to a blood pressure fluctuation measuring device (not shown), where the blood pressure fluctuations are successively measured. The inner lumen of the inner tube 130 located inside the balloon 110 is also used as an insertion lumen for a guide wire when the catheter 100 is inserted into an artery.

[0035] On the other hand, the pressure transmission bulkhead device 10 to which the catheter 100 is detachably connected has a pressure vessel 12 which forms a gas pressure chamber 11 to which the catheter 100 is communicatively connected, a driving pressure chamber 14 which introduces a driving pressure Pi from a pumping drive mechanism 13, and a diaphragm 15 (pressure-receiving member) which airtightly divides the inside of the pressure vessel 12 into the primary side driving pressure chamber 14 and the secondary side gas pressure chamber 11.

[0036] When the catheter 100 is connected to the pressure transmitting bulkhead device 10, the gas pressure chamber 11 communicates with the inside of the balloon 110 from the base end side to the tip end side of the catheter 100, which constitutes the secondary piping system L2, via the communication hole 12a of the pressure vessel 12. A predetermined internal gas, for example, helium gas, is supplied to this gas pressure chamber 11 from the refilling device 30, which will be described later, via the auxiliary device 40. The inside of the gas pressure chamber 11 in the pressure vessel 12, the inside of the balloon 110 of the catheter 100, and the piping in the medical inflation / deflation drive device 1 and the tubular portion of the catheter 100 which communicate between them are collectively referred to as the secondary piping system L2.

[0037] The pressure vessel 12 is, for example, a hollow vessel having a substantially circular disk shape, and the primary driving pressure chamber 14 and the secondary gas pressure chamber 11 separated by the diaphragm 15 are also substantially circular disk-shaped. The diaphragm 15 is adapted to increase or decrease the volume of the secondary gas pressure chamber 11 in the pressure vessel 12 by elastically deforming or displacing at least a portion of the diaphragm 15 in the left-right direction in FIG. 1 in response to the driving pressure Pi applied to the primary driving pressure chamber 14, thereby allowing the internal gas of the catheter 100 to reciprocate in the direction of flow into the balloon 110 and the direction of flow out from the balloon 110.

[0038] In other words, when the diaphragm 15 receives alternating positive and negative pressure from the driving pressure chamber 14 as the driving pressure Pi, the pressure transmission bulkhead device 10 functions as a gas operating unit that operates the gas in the gas pressure chamber 11 to move back and forth in the expansion and contraction directions of the balloon 110 by changing the volume that the gas pressure chamber 11 can accommodate for the internal gas in accordance with the elastic deformation or displacement of the diaphragm 15.

[0039] As described above, the pumping drive mechanism 13 is capable of applying positive pressure and negative pressure alternately to the driving pressure chamber 14 on the primary side of the pressure transmission partition device 10 .

[0040] Specifically, the pumping drive mechanism 13 includes a positive pressure tank 22 that is detachably connected to the driving pressure chamber 14 via a positive pressure drive valve 21, a positive pressure pump 23 that discharges a positive pressure that is sufficiently higher than the blood pressure of the patient to be measured at a discharge pressure that can be stored in the positive pressure tank 22, a regulator valve 24 that adjusts the supply pressure from the positive pressure pump 23 to the positive pressure tank 22 to a predetermined positive pressure value, a negative pressure tank 27 that is detachably connected to the driving pressure chamber 14 via a negative pressure drive valve 26, a negative pressure pump 29 connected to the negative pressure tank 27 via a variable throttle valve 28 on the suction port (negative pressure port) side, a primary piping system L1 that provides connections for transmitting the positive pressure and negative pressure in the positive pressure tank 22 and the negative pressure tank 27, respectively, to the driving pressure chamber 14, and a plurality of pressure regulating valves not shown.

[0041] The refilling device 30 supplies gas in a pressurizable manner from a gas supply source 31, such as a helium gas cylinder, via a regulator valve 32 and a first solenoid valve 33 to a refilling tank 34, and supplies the gas from the refilling tank 34 to the auxiliary device 40 via a second solenoid valve 35 in order to replenish the catheter 100.

[0042] The auxiliary device 40 has an auxiliary tank 41 which forms an auxiliary pressure chamber that stores the gas replenished from the refilling device 30 in an accumulating manner, an auxiliary valve 42 which can selectively supply gas from the auxiliary tank 41 to the gas pressure chamber 11 or to the inside of the catheter 100 (the secondary piping system L2 side of the pressure vessel 12), and a purge valve 43 which is connected to the auxiliary tank 41 and can purge (exhaust) gas from the auxiliary tank 41 into a vacuum tank 44, thereby assisting the flow of replenishment gas from the refilling device 30 to the catheter 100.

[0043] Here, the auxiliary tank 41 is a gas tank that can supply part of the gas in the tank to the secondary piping system L2 or return part of the gas from the secondary piping system L2 to the tank depending on the pressure difference between the tank internal pressure and the secondary piping system L2, and is connected to the secondary piping system L2 via an auxiliary valve 42.

[0044] In addition, the catheter 100 or the pressure transmission bulkhead device 10 is equipped with a pressure sensor 51 for detecting the gas pressure in the secondary piping system L2, and the auxiliary tank 41 of the auxiliary device 40 is equipped with a pressure sensor 55 for detecting the internal pressure of the tank. Furthermore, the positive pressure tank 22 and the negative pressure tank 27 of the pumping drive mechanism 13 and the refill tank 34 of the refill device 30 are equipped with pressure sensors 52, 53, 54, etc. for detecting their respective internal pressures. The operation of the pumping drive mechanism 13, the refill device 30, and the auxiliary device 40 is controlled by the controller 60, which controls the operation of the positive pressure pump 23 and the negative pressure pump 29 and the opening and closing of the multiple valves 21, 26, 33, 35, 42, 43, etc.

[0045] The controller 60 has, as a plurality of functional sections corresponding to a plurality of built-in control programs, an input monitoring control section 61, an information output control section 62, a pumping drive control section 63, and a gas replenishment control section 64. In addition, the controller 60 is connected to a plurality of pressure sensors 51-55 etc. so as to be able to take in the respective pressure information, and is also connected to an adjustment operation input section 71, an alarm release operation section 72, a blood pressure variation measuring device 73, and an electrocardiogram measuring device 74 so as to be able to send and receive signals.

[0046] Furthermore, the controller 60 is connected to a display output unit 65 (pressure display unit) capable of displaying images, numerical values, and the like on a screen, and an alarm output unit 66 capable of outputting optical and audio information.

[0047] Specifically, the controller 60 is composed of a microprocessor, a programmable controller, etc., and performs various calculations of the device in accordance with a stored control program, thereby causing the input monitoring control unit 61 to monitor and calculate various input information, the information output control unit 62 to control display and alarm output, the pumping drive control unit 63 to control the pumping (inflation and deflation) drive of the balloon 110, and the gas replenishment control unit 64 to control gas replenishment.

[0048] In addition, the various types of input information taken into the input monitoring control unit 61 are each converted into a signal form that can be taken in via an input interface not shown, and the various control signals output from the information output control unit 62, the pumping drive control unit 63 and the gas replenishment control unit 64 are converted into the required control signal form by an output interface and driver circuit not shown.

[0049] More specifically, the input monitoring control unit 61 calculates necessary input information, such as heart rate, systolic pressure, diastolic pressure, mean pressure, augmentation pressure, etc., based on pressure information from multiple pressure sensors 51-55, etc. and measurement information from a blood pressure fluctuation measuring device 73 and an electrocardiogram measuring device 74, etc.

[0050] The information output control unit 62 has an information output means 62a that generates screen display and numerical display information to be output from the display output unit 65 and the alarm output unit 66 based on the monitoring information and calculation information in the input monitoring control unit 61, and an alarm generation means 62b that generates an alarm described below based on the monitoring information and calculation information in the input monitoring control unit 61.

[0051] The pumping drive control unit 63 stores in a memory setting conditions such as a preset monitoring pressure, an adjustment ratio (assist ratio) of the pumping drive pressure according to an adjustment operation input from the adjustment operation input unit 71, and drive timing, and controls the operation of the pumping drive mechanism 13 based on the stored information. The pumping drive control unit 63 functions to control the positive pressure drive valve 21, the negative pressure drive valve 26, the positive pressure pump 23, the negative pressure pump 29, etc., so that positive pressure and negative pressure can be applied alternately to the gas in the gas pressure chamber 11 via the diaphragm 15.

[0052] In addition, the pumping drive control unit 63 detects predetermined signal changes in the electrocardiogram waveform or blood pressure waveform as a trigger according to its control program, and alternately opens the positive pressure drive valve 21 and the negative pressure drive valve 26 based on that trigger.

[0053] Furthermore, the pumping drive control unit 63 applies positive pressure and negative pressure to the gas in the gas pressure chamber 11 at a predetermined timing and for a predetermined time by alternately opening the positive pressure drive valve 21 and the negative pressure drive valve 26, thereby inflating the balloon 110 at approximately the same time as the aortic valve closes at the start of cardiac diastole, thereby exerting the so-called diastolic augmentation effect (increasing coronary artery blood flow and maintaining mean aortic pressure, etc.; shown by D in Figure 4), and deflating the balloon 110 at the timing when the end-diastolic arterial pressure reaches approximately its minimum value, thereby exerting the so-called systolic unloading effect (reducing cardiac workload and suppressing myocardial oxygen consumption due to a decrease in end-diastolic and systolic blood pressure; shown by S in Figure 4).

[0054] 5, the pumping drive control unit 63 closes the positive pressure drive valve 21 after a second predetermined time T2, which is a positive pressure drive time, for example, about 150 msec has elapsed from the time tp when the positive pressure is applied to the secondary piping system L2 through the pressure vessel 12 incorporating the diaphragm 15 by opening the positive pressure drive valve 21 of the pumping drive mechanism 13 (the time when the negative pressure is switched to the positive pressure). The pumping drive control unit 63 also opens the auxiliary valve 42 after a predetermined expansion assistance waiting time Ta, for example, about 160 msec, has elapsed from the time tp when the positive pressure application is started (i.e., about 10 msec after the positive pressure drive valve 21 is closed), and executes control to close the auxiliary valve 42 before the next switching from positive pressure to negative pressure, for example, about 10 msec before the next switching time tn.

[0055] Since the positive pressure in the positive pressure tank 22 is higher than the internal pressure in the auxiliary tank 41, when the auxiliary valve 42 opens under the condition that the positive pressure drive valve 21 is opened and positive pressure is applied to the secondary piping system L2, positive pressure is applied to the gas in the auxiliary tank 41 as well as the secondary piping system L2, and the pressure of the gas in the secondary piping system L2 drops below the peak pressure P5 immediately after the positive pressure drive and converges. Therefore, the stable pressure (stable pressure after expansion) of the balloon internal pressure (usually equal to the pressure inside the gas pressure chamber 11) after the balloon 110 is fully expanded and overshoots usually converges near the plateau pressure P4 in the balloon internal pressure waveform as shown in FIG. 5(a), and remains in a substantially constant pressure state near the plateau pressure P4 until the next switching.

[0056] Similarly, the pumping drive control unit 63 closes the negative pressure drive valve 26 of the pumping drive mechanism 13 after a third predetermined time T3, for example, about 150 msec, has elapsed from the time tn (the time of switching from positive pressure to negative pressure) when negative pressure is started to be applied to the secondary piping system L2 via the pressure vessel 12 incorporating the diaphragm 15 by opening the negative pressure drive valve 26. The pumping drive control unit 63 also executes control to open the auxiliary valve 42 after a predetermined contraction assistance waiting time Tb, for example, about 160 msec, has elapsed from the time tn (the time of switching from positive pressure to negative pressure) when the above-mentioned negative pressure application is started (i.e., about 10 msec after the time when the negative pressure drive valve 26 is closed), and closes the auxiliary valve 42 before the next switching from negative pressure to positive pressure, for example, about 10 msec before the next switching time tp.

[0057] Since the negative pressure in the negative pressure tank 27 is lower than the internal pressure in the auxiliary tank 41, when the auxiliary valve 42 opens under the condition that the negative pressure drive valve 26 is open and negative pressure is applied to the secondary piping system L2, the pressure in the secondary piping system L2 rises according to the amount of gas supplied from the auxiliary tank 41. Therefore, the balloon internal pressure after the balloon 110 has completely deflated and undershoots usually appears as a waveform portion in the balloon internal pressure waveform that is in a substantially constant pressure state near the reference pressure P1 until the next switching, as shown in Figure 5(a). This reference pressure P1 is a pressure value on the negative pressure side of atmospheric pressure (0 mmHg).

[0058] Here, the timing for opening the auxiliary valve 42 (the above-mentioned inflation auxiliary wait time Ta, deflation auxiliary wait time Tb) can be selected as an optimal time in relation to the inflation or deflation state of the balloon 110, and can be set, for example, as the time from the time of switching to positive pressure to the time when the balloon 110 is fully inflated, or from the time of switching to negative pressure to the time when the balloon 110 is fully deflated. This predetermined time can be obtained, for example, by experimentally applying positive or negative pressure to the balloon 110 in a simulation test with a back pressure of 70 mmHg (gauge pressure) and actually measuring the change in volume of the balloon 110.

[0059] In this way, when the pumping drive control unit 63 operates the pumping drive mechanism 13 to apply positive pressure to the secondary piping system L2 including the balloon 110 of the catheter 100, the pressure in the secondary piping system L2 once exceeds the plateau pressure and overshoots, then decreases to the plateau pressure, and remains substantially constant until the next switch (switch to negative pressure), and when the pressure in the secondary piping system L2 drops due to the next switch to negative pressure, the pressure in the secondary piping system L2 undershoots the reference pressure (pressure when the balloon 110 is fully deflated) P1, then increases to the reference pressure P1, and remains substantially constant until the next switch to positive pressure, and these are repeated in sequence. As a result, the balloon 110 can be inflated and deflated in accordance with the heart rate (heart beats at regular intervals) obtained by the input monitoring control unit 61, and auxiliary circulation treatment using the catheter 100 is possible.

[0060] Here, the pumping drive mechanism 13 changes the drive pressure Pi applied to the diaphragm 15 in response to an input signal from the pumping drive control unit 63, and serves as a direction switching unit that switches the direction of the gas movement operation in the gas pressure chamber 11.

[0061] The gas replenishment control unit 64 controls the operation of the multiple valves 21, 26, 33, 35, 42, 43, etc., and the positive pressure pump 23 and negative pressure pump 29 based on pressure information from the multiple pressure sensors 51-55, etc., operation input information to the adjustment operation input unit 71 and the alarm release operation unit 72, and measurement information from the blood pressure variation measuring device 73 and the electrocardiogram measuring device 74, etc., in order to control the supply, replenishment, discharge, etc. of gas into the gas pressure chamber 11.

[0062] This gas replenishment control unit 64 can replenish part of the gas on the auxiliary tank 41 side into the secondary piping system L2 or discharge part of the gas in the secondary piping system L2 to the auxiliary tank 41 side by opening the auxiliary valve 42 at a predetermined timing, for example, in accordance with the pressure difference between the internal pressure of the secondary piping system L2 and the internal pressure of the auxiliary tank 41.

[0063] In addition, an exhaust valve 17 that causes leakage from the gas pressure chamber 11 through an impurity removal filter or the like is connected to the pressure vessel 12, and the controller 60 having the multiple functional parts as described above opens the exhaust valve 17 to the atmospheric pressure side when the pressure inside the gas pressure chamber 11 detected by the pressure sensor 51 (in the following description, this pressure may be referred to as the balloon internal pressure) exceeds a predetermined pressure, thereby enabling the gas pressure chamber 11 to be subjected to the required amount of pressure reduction treatment due to leakage.

[0064] In addition, when the air pressure in the positive pressure tank 22 detected by the pressure sensor 52 exceeds a predetermined positive pressure value, the controller 60 controls the opening of a valve for adjusting leakage and a valve for releasing pressure to the atmospheric pressure side (not shown), and when the air pressure in the negative pressure tank 27 detected by the pressure sensor 53 falls outside the predetermined negative pressure range, the controller 60 controls the opening of the valve for adjusting leakage, etc.

[0065] Furthermore, the controller 60 drives the positive pressure pump 23 or the negative pressure pump 29 in accordance with the air pressure in the positive pressure tank 22 detected by the pressure sensor 52 and the air pressure in the negative pressure tank 27 detected by the pressure sensor 53, thereby increasing the air pressure in the positive pressure tank 22 to a predetermined positive pressure level and maintaining the air pressure in the negative pressure tank 27 within a predetermined negative pressure range.

[0066] Information on the pressures detected by the pressure sensors 51-54 and the pressure sensor 55 (gas pressure measuring section) that detects the gas pressure in the auxiliary tank 41 is input to an input monitoring control section 61 of the controller 60 at predetermined time intervals.

[0067] Then, the controller 60 supplies gas from the gas supply source 31 to the refill tank 34 via the regulator valve 32 and the first electromagnetic valve 33 based on detection information from the pressure sensors 51-55, etc., and gas is refilled from the refill tank 34 to the auxiliary tank 41 in response to opening and closing of the second electromagnetic valve 35. The refill amount at this time is proportional to the internal volume of the auxiliary tank 41 and the pressure difference after the completion of gas refilling with respect to the pressure in the auxiliary tank 41 before gas refilling.

[0068] In addition, based on detection information from pressure sensors 51-55, etc., the auxiliary valve 42 (or further the purge valve 43) is controlled by the controller 60 as necessary, so that the flow of gas (flow direction and flow rate) in the refilling direction from the auxiliary tank 41 to the balloon 110 of the catheter 100, or the flow of gas in the discharge direction toward the negative pressure tank 27, can be adjusted.

[0069] As described above, the operation of the pumping drive mechanism 13 is controlled by the pumping drive control unit 63 based on the monitoring information and calculation information in the input monitoring control unit 61, and when the pressure transmission bulkhead device 10 operates to move the gas in the gas pressure chamber 11, the auxiliary valve 42 is controlled to open by the controller 60, thereby connecting the auxiliary tank 41 to the secondary piping system L2 as necessary.

[0070] Here, the auxiliary tank 41 and auxiliary valve 42 of the auxiliary device 40 and the gas replenishment control unit 64 of the controller 60 constitute a gas adjustment unit 59 that adjusts the flow of gas in the gas pressure chamber 11, which is moved by the pressure transmission bulkhead device 10, and can adjust the internal pressure of the balloon 110 to a preset plateau pressure P4 or reference pressure P1 as a stable pressure after fluctuations have subsided during a specified pressure adjustment period.

[0071] This gas adjustment unit 59 is configured to converge the pressure in the secondary piping system L2 immediately after the pumping drive mechanism 13 drives it to positive pressure in the direction of convergence by opening the auxiliary valve 42, and to accumulate and hold the pressure in the auxiliary tank 41 equivalent to the plateau pressure in the secondary piping system L2 by closing the auxiliary valve 42. The information output control unit 62 of the controller 60 is configured to cause the pressure sensor 55 to measure the internal pressure of the auxiliary tank 41 in the accumulated and held state, and to numerically display the measured value on the display output unit 65 as a monitored pressure equivalent to the plateau pressure.

[0072] In addition, the gas adjusting unit 59 also has a function of selectively reducing the internal pressure of the auxiliary tank 41 by activating the purge valve 43 .

[0073] In addition to controlling the supply, replenishment, and discharge of gas to the gas pressure chamber 11 as described above, the controller 60 controls the opening and closing of the first solenoid valve 33, the second solenoid valve 35, the auxiliary valve 42, and the purge valve 43 based on pressure information from the pressure sensors 51-55, etc., in accordance with a control program stored inside, thereby enabling the initial filling of gas in the gas pressure chamber 11 and the catheter 100 and the replacement (gas substitution) of the gas after a predetermined period of time has elapsed.

[0074] When an abnormality is detected in the input information monitored by the input monitoring control unit 61 or in the calculated values ​​based on the input information, the display output unit 65 and the alarm output unit 66 output a warning signal to the display unit 65. ... [ mmHg ])If the pressure falls outside the above range to the lower pressure side, a warning is issued by displaying and / or sounding a pressure abnormality, so that the user can be notified of the abnormality.

[0075] The information output control unit 62 and the display output unit 65 are configured to display and output the sequentially measured pressure P3 of the pressure sensor 51 that measures at least the internal pressure of the gas pressure chamber 11, for example, as a balloon internal pressure waveform as shown by the solid line in Figure 5 (see Figure 5(a)).

[0076] The alarm output unit 66 outputs visual and audible alarms, for example, when the internal pressure of the balloon 110 falls outside the normal range. The alarm output unit 66 has, for example, a pilot lamp and an alarm sound generator disposed at the upper center of the display output unit 65, and when a pressure abnormality occurs in which the monitored pressure falls outside a predetermined range, the pilot lamp flashes red and the alarm sound generator generates an intermittent alarm sound. If the pressure abnormality does not disappear after the alarm operation or a release signal to release the alarm operation is not input, the controller 60 can stop the pumping drive of the balloon 110.

[0077] The adjustment operation input unit 71 is an adjustment operation input unit that generates an operation signal for adjusting the internal pressure of the balloon 110 in response to an input operation from a user who refers to the above-mentioned monitored pressure.

[0078] The alarm cancellation operation unit 72 is capable of issuing a command to temporarily suspend the alarm output from the display output unit 65 and the alarm output unit 66, and a command to cancel the alarm.

[0079] In this manner, in this embodiment, when the gas in the gas pressure chamber 11 is moved in the direction of expanding the balloon 110 by the pressure transmission bulkhead device 10, which is the gas operating unit, the gas adjustment unit 59 opens the auxiliary valve 42 at a predetermined timing, thereby causing the internal pressure of the balloon 110 to converge to the plateau pressure P4 shown in Figure 5(a) during a predetermined expansion side auxiliary period Ti shown in Figure 5(e).

[0080] In addition, when the pressure transmitting bulkhead device 10 operates to move the gas in the gas pressure chamber 11 in the direction of deflating the balloon 110, the gas adjusting unit 59 opens the auxiliary valve 42 at a predetermined timing (the purge valve 43 may be opened at the same time), thereby converging the internal pressure of the balloon 110 within a certain range of the reference pressure P1, for example, within a range equal to or greater than P1j (=P1-10 [mmHg]), during a predetermined deflating side auxiliary period Td shown in FIG. 5(e).

[0081] The pumping drive mechanism 13, which is a direction switching unit, changes the drive pressure Pi to positive pressure and negative pressure to switch the direction of the internal gas movement operation by the pressure transmission partition device 10 between the inflow direction and outflow direction relative to the balloon 110, and when moving in the inflow direction, increases the pressure in the gas pressure chamber 11 from the stable pressure side after contraction of the balloon 110 (reference pressure P1 side), while when moving in the outflow direction, decreases the pressure in the gas pressure chamber 11 from the stable pressure side after expansion of the balloon 110 (plateau pressure P4 side).

[0082] Furthermore, during the auxiliary operation by the auxiliary device 40, the gas regulator 59 adjusts the pressure of the gas pressure chamber 11 depending on the communication state between the auxiliary pressure chamber 41 and the gas pressure chamber 11, so that the gas supplied into the auxiliary tank 41 is supplied into the secondary piping system L2 by the next auxiliary operation (opening of the auxiliary valve 42). Therefore, part of the internal gas in the secondary piping system L2 is replaced with new gas (semi-purged). Moreover, by repeating this operation an appropriate number of times, the gas in the secondary piping system L2 can be entirely replaced (full-purged).

[0083] Incidentally, the input monitoring control unit 61 of the controller 60 is provided with a pressure determination unit 61a which determines the presence or absence of a pressure abnormality for the pressure (balloon internal pressure) in the secondary piping system L2, which is the fluid connection line from the inside of the balloon 110 to the inside of the gas pressure chamber 11, based on the detection information of the pressure sensor 51. The pumping drive control unit 63 of the controller 60 is provided with, in addition to the main drive control means 63a, an abnormality release operation means 63b (abnormality release operation unit) which, when the pressure determination unit 61a determines that there is a pressure abnormality in the fluid connection line 2, closes the auxiliary valve 42 to isolate the auxiliary pressure chamber 41 from the gas pressure chamber 11, and in a state in which the volume of the secondary piping system L2 has been reduced by this isolation, performs an abnormality release operation for the pressure abnormality by applying a positive drive pressure Pi.

[0084] The abnormality release operation means 63b is adapted to execute control for executing an abnormality release operation for the purpose of eliminating or alleviating the condition causing the pressure abnormality by increasing the pressure in the gas pressure chamber 11 while the volume in the secondary piping system L2 is small during the initial operation of the catheter 100 and when a pressure abnormality occurs, thereby greatly increasing the pressure in the catheter 100 and expanding the balloon 110, and using the resulting force and reaction. Examples of conditions causing pressure abnormalities that can be eliminated or alleviated by this abnormality release operation include meandering of the blood vessel at the placement position of the balloon 110, curling of the balloon 110, and twisting of the catheter tube 124.

[0085] Based on the judgment result of the pressure judgment unit 61a, the controller 60 operates the abnormality removal operation means 63b, and when the pressure abnormality is removed by the abnormality removal operation, it executes the inflation and deflation drive of the balloon 110 of the balloon catheter 100 in accordance with the input of the driving pressure Pi, and checks whether the stable pressure after a predetermined number of deflations falls within a predetermined range of the reference pressure Pi to confirm that the pressure abnormality has been resolved.

[0086] On the other hand, when the pressure abnormality is not resolved even by the operation of the abnormality resolution operation means 63b (abnormality resolution operation), the controller 60 stops the driving of the inflation and deflation of the balloon 110 of the balloon catheter 100 in response to the input of the driving pressure Pi.

[0087] In addition, the input monitoring control unit 61 of the controller 60 further has a reference pressure measuring means 61b (post-contraction stable pressure measuring means) that, when the pressure determination unit 61a determines based on the detection information of the pressure sensor 51 that there is a pressure abnormality in the secondary piping system L2, which is the fluid connection line, first measures the post-contraction stable pressure (P1') based on the detection information of the pressure sensor 51 in a resting state in which the movement operation of the pressure transmission bulkhead device 10 is stopped.

[0088] When the pressure determination unit 61a determines that there is a pressure abnormality in the secondary piping system L2, which is the fluid connection line, and the post-contraction stable pressure (P1) measured by the reference pressure measurement means 61b falls within a preset allowable range for the reference pressure P1 (atmospheric pressure > (P1) > P1j [mmHg]), the abnormality removal operation means 63b performs the abnormality removal operation a predetermined number of times, for example once under the same conditions as at the time of initial startup, with the auxiliary pressure chamber 41 isolated from the gas pressure chamber 11.

[0089] Furthermore, when the pressure determination unit 61a determines that there is still a pressure abnormality in the secondary piping system L2, which is the fluid connection line, even after the abnormality removal operation means 63b has performed the abnormality removal operation a predetermined number of times, the controller 60 stops the inflation and deflation of the balloon 110 of the balloon catheter 100 in response to the input of the driving pressure Pi, and generates a predetermined alarm signal by the alarm generation means 62b and outputs it from the alarm output unit 66.

[0090] The controller 60 is also equipped with a drive start switch 75 that is manually operated to return to normal drive when a predetermined alarm signal is output by the alarm generating means 62b, and commands the pressure transmission bulkhead device 10 to start operating according to the drive pressure Pi. This drive start switch 75 is manually operated after the user has taken necessary measures after the predetermined alarm is output by the alarm generating means 62b. Furthermore, the controller 60 is configured to operate the abnormality release operation means 63b again when the drive start switch 75 is manually operated to return to normal drive and the pressure determination unit 61a continues to determine that there is a pressure abnormality in the secondary piping system L2, which is a fluid connection line. Therefore, if the user takes measures in response to the predetermined alarm output and the pressure abnormality state is resolved, the normal drive of the medical inflation / deflation drive device 1 is started in response to the manual operation of the drive start switch 75, and on the other hand, if the pressure abnormality state is not resolved, the abnormality release operation by the abnormality release operation means 63b can be performed again or the user can take further measures.

[0091] The medical inflation / deflation drive device 1 of this embodiment is equipped with an exhaust valve 17 as exhaust means capable of exhausting the gas in the gas pressure chamber 11 to the atmosphere side, and a gas replenishment control unit 64 as gas replacement means for replenishing the gas pressure chamber 11 with new gas from the auxiliary tank 41 side while allowing the gas in the gas pressure chamber 11 to be exhausted to the atmosphere side by the exhaust valve 17. There are.

[0092] Next, the operation will be described.

[0093] First, to outline the operation, in this embodiment, the change in pressure in the secondary piping system L2 accompanying the application of a positive or negative driving pressure Pi by the pumping drive mechanism 13 (pressure generating means) is as follows: when positive pressure is applied, the pressure in the secondary piping system L2 rises, the pressure overshoots higher than the plateau pressure P4, then decreases to the plateau pressure, and becomes a substantially constant post-expansion stable pressure until the next switching (switching to negative pressure). Then, by switching to negative pressure, the pressure in the secondary piping system L2 drops, the pressure undershoots lower than the reference pressure P1, then increases to the vicinity of the reference pressure P1, and becomes a substantially constant post-contraction stable pressure until the next switching (switching to positive pressure). Then, such a change in pressure in the secondary piping system L2 is repeated in response to the alternating switching of the driving pressure Pi to positive pressure and negative pressure.

[0094] In addition, when the auxiliary valve 42 opens after a predetermined time has elapsed since the time when it is switched to positive pressure, positive pressure is applied in the secondary piping system L2, so an auxiliary operation is performed in which part of the gas in the secondary piping system L2 is sucked into the auxiliary tank 41. On the other hand, when the auxiliary valve 42 opens after a predetermined time has elapsed since the time when it is switched to negative pressure, negative pressure is applied in the secondary piping system L2, so an auxiliary operation is performed in which part of the gas in the auxiliary tank 41 is discharged into the secondary piping system L2 due to the pressure difference with the secondary piping system L2. Therefore, by optimizing the predetermined time from each switching point to positive pressure and negative pressure (for example, near the time when the driven equipment is fully inflated or fully deflated), it is possible to reduce the difference between the plateau pressure P4' and the reference pressure P1' when the auxiliary operation is performed by opening the auxiliary valve 42 as shown in FIG. 6(b) compared to the difference between the plateau pressure P4' and the reference pressure P1' when there is no auxiliary operation by opening the auxiliary valve 42 as shown in FIG. 6(a). Therefore, when the balloon 110 is inflated with gas, an acceleration function can be exerted to shorten the time required for the balloon 110 to reach a stable post-inflation pressure near the plateau pressure P4 from a post-deflation reference pressure near the reference pressure P1, and when the balloon 110 is inflated with gas, an acceleration function can be exerted to shorten the time required for the balloon 110 to reach a stable post-inflation pressure near the plateau pressure P4 from a post-inflation reference pressure near the reference pressure P1. As a result, the responsiveness of the inflation / deflation drive of the balloon 110 is improved.

[0095] As shown in Figure 5, in this embodiment, a predetermined signal change in the blood pressure waveform or electrocardiogram waveform is used as a trigger, and the positive pressure drive valve 21 and the negative pressure drive valve 26 are alternately driven to open at a timing after a first predetermined time T1 based on the trigger, thereby alternating between a balloon inflation period in which the balloon 110 is inflated and a balloon deflation period in which the balloon 110 is deflated.

[0096] Also, immediately after the start of the balloon inflation (expansion) period, with the negative pressure driving valve 26 in a closed state, the positive pressure driving valve 21 opens for a predetermined positive pressure driving period T2, and then, when the inflation assist wait time Ta has elapsed from the start of the balloon inflation period, the auxiliary valve 42 opens for a predetermined inflation side assist period Ti. Furthermore, after the negative pressure driving valve 26 opens for a predetermined negative pressure driving period T3 with the positive pressure driving valve 21 in a closed state, when the deflation assist wait time Tb has elapsed from the start of the balloon deflation period, the auxiliary valve 42 opens for a predetermined deflation side assist period Td.

[0097] Therefore, in response to the alternating opening of the positive pressure drive valve 21 and the negative pressure drive valve 26, the gas in the secondary piping system L2 connected to the gas pressure chamber 11 is moved in the expansion and contraction directions from the drive pressure chamber 14 side via the diaphragm 15, and the auxiliary operation described above is possible, involving the gas on the auxiliary tank 41 side flowing in and out of the secondary piping system L2.

[0098] As a result, for example, the balloon 110 can be inflated simultaneously with the closure of the aortic valve at the start of cardiac diastole to achieve a diastolic augmentation effect (increasing coronary artery blood flow and maintaining mean aortic pressure), or the balloon 110 can be deflated at the timing when the end-diastolic arterial pressure reaches its minimum to achieve a systolic unloading effect (reducing cardiac workload and suppressing myocardial oxygen consumption by reducing end-diastolic and systolic blood pressure).

[0099] Next, a process to be performed in the event that a pressure abnormality occurs during the above-mentioned operation will be described.

[0100] In this embodiment, during a series of balloon pumping operations, pressure abnormality detection and response processing as shown in FIG. 7 is executed.

[0101] First, the pressure determination unit 61a determines whether or not there is a pressure abnormality in the secondary piping system L2, which is a fluid connection line, based on the detected pressure at a predetermined detection timing among the detected pressures of the pressure sensor 51 that are input into the controller 60 at predetermined time intervals (step S11).

[0102] The predetermined detection timing here is the detection timing tc3 of the stable post-deflation pressure shown in Fig. 6 or immediately before that, and the detected pressure at the predetermined detection timing is the pressure (balloon internal pressure) in the gas pressure chamber 11 (secondary piping system L2) corresponding to the stable post-deflation pressure (shown as (P1) in the figure). If the balloon internal pressure detected at this detection timing tc3 is equal to or higher than the lower limit pressure P1j (e.g., P1-10 [mmHg]) of the stable post-deflation pressure (if No in step S11), it is determined that there is no pressure abnormality, and the presence or absence of a pressure abnormality in the secondary piping system L2 is determined again after a predetermined time by the pressure determination unit 61a (step S11). During the pressure monitoring period for determining pressure abnormality in step S11, once the balloon internal pressure detected at detection timing tc3 in FIG. 6 is no longer equal to or higher than the lower limit pressure P1j of the normal post-deflation stable pressure, the balloon internal pressure detected at detection timing tc3 is checked a predetermined number of times for a predetermined time (e.g., 4 seconds), and the presence or absence of a pressure abnormality in the secondary piping system L2 is determined based on the multiple detection values.

[0103] If the balloon pressure detected at the detection timing tc3 is less than the lower limit pressure P1j of the stable pressure after deflation and it is determined that there is a pressure abnormality (Yes in step S11), the gas transfer operation for driving the inflation and deflation of the balloon 110 is stopped and the system transitions to a resting state (step S12), and after the resting state, it is checked whether the balloon pressure is within the allowable range of the preset reference pressure P1 (below atmospheric pressure and above the lower limit pressure P1j) (step S13). At this time, if there is no serious abnormality such as a gas leak in the secondary piping system L2 or a complete blockage of the catheter tube 124, the balloon pressure detected at the detection timing tc3 will be within the allowable range of the reference pressure P1 (below atmospheric pressure and above the lower limit pressure P1j), which is a normal value for the reference pressure P1.

[0104] Therefore, if, during the check after this pause, the balloon internal pressure is in an abnormal reference pressure state that is not within the allowable range of the reference value P1 (Yes in step S13), it is determined that there is a suspicion of a gas leak, etc., and event processing is executed (step S14) to transition to gas leak processing similar to the gas leak warning described in Patent Document 1 (an alarm is output when a gas leak is determined to be present based on the change over time in the amount of gas replenishment by the gas replenishment means), and the current processing is terminated.

[0105] Furthermore, if, during the check after the rest period, the balloon internal pressure falls within the allowable range of the reference value P1 (No in step S13), an abnormality recovery operation is executed to increase the pressure in the gas pressure chamber 11 under conditions similar to those during the initial operation of the balloon catheter 100, with the auxiliary tank 41 isolated from the gas pressure chamber 11, as an operation to increase the balloon internal pressure to an extent that the balloon 110 can be straightened out (step S15).

[0106] Next, the flow returns to the normal inflation / deflation drive state accompanied by auxiliary operation (auxiliary valve drive state) (step S16), and a check is made for a predetermined time to see whether or not the balloon internal pressure corresponding to the stable post-deflation pressure (P1) at the detection timing tc3 has not yet returned to within the allowable range of the preset reference pressure P1, indicating an unresolved alarm and abnormal pressure state (step S17).

[0107] If the pressure abnormality has not been resolved (Yes in step S17), an alarm signal for notifying the user of the occurrence of the abnormality is generated by the alarm generating means 62b, and a predetermined alarm is output from the alarm output unit 66 (step S18).

[0108] Based on the warning, the user investigates the cause of the pressure abnormality and takes measures, and when the user determines that the cause of the pressure abnormality has been eliminated, the user manually operates the drive start switch 75. Then, when the drive start switch 75 is operated, the pressure abnormality detection and response process shown in Fig. 7 is started again, and when the drive start switch 75 is manually operated after a predetermined warning is output by the warning generating means 62b, and the pressure determination unit 61a determines that the pressure abnormality in the secondary piping system L2 has been eliminated, normal expansion / contraction drive is executed.

[0109] In addition, when the drive start switch 75 has been manually operated but the pressure determination unit 61a continues to determine that there is a pressure abnormality in the secondary piping system L2, the controller 60 can operate the abnormality removal operation means 63b again, allowing the user to take action again.

[0110] On the other hand, if the pressure abnormality has been resolved (No in step S17), the alarm generating means 62b does not generate an alarm signal to inform the user of the occurrence of the abnormality, no alarm is output from the alarm output unit 66, and the inflation and deflation drive of the balloon 110 continues (step S19).

[0111] In this manner, in this embodiment, when the pressure abnormality in the secondary piping system L2 is cleared by the abnormality clearing operation, the inflation / deflation drive of the balloon 110 continues in response to the input of the driving pressure Pi. This makes it possible to effectively prevent the medical inflation / deflation drive device 1 from being stopped due to a pressure abnormality occurring in the secondary piping system L2 (fluid connection line), and reliably reduces the frequency of such stoppages.

[0112] Furthermore, in this embodiment, the pressure determination unit 61a accurately determines whether or not there is a pressure abnormality in the fluid connection line, and when there is a high probability of the pressure abnormality being cleared and there is no serious abnormality such as a gas leak or complete blockage of the fluid connection line, the abnormality clearing operation means 63b reliably executes the abnormality clearing operation, thereby reliably reducing the frequency of unnecessary drive stops.

[0113] Furthermore, when the pressure abnormality in the secondary piping system L2 is not resolved by performing the abnormality removal operation a predetermined number of times by the abnormality removal operation means 63b, the inflation and deflation drive of the balloon 110 in response to the input of the driving pressure Pi is stopped and a predetermined alarm is output. This alarm output can reliably notify the user of the state in which the drive has been stopped due to the occurrence of an abnormality, and can prompt the user to take more effective manual operation to remove the abnormality or other measures and decisions.

[0114] In addition, in this embodiment, the abnormality recovery operation can be easily and effectively performed by manually operating the drive start switch 75.

[0115] In addition, with the gas in the gas pressure chamber 11 and the balloon 110 exhausted to the atmosphere by the exhaust valve 17, the gas replenishment control unit 64 replenishes new gas into the gas pressure chamber 11 from inside the auxiliary tank 41, so it is possible to adequately deal with problems such as deterioration of driving performance due to leakage of the working gas used to drive the inflation and deflation of the balloon 110, and reduced responsiveness of balloon pumping due to contamination or deterioration of the working gas.

[0116] Furthermore, in this embodiment, since the auxiliary circulation device such as the balloon catheter 100 for IABP is used as the driven equipment, the balloon catheter 100 can be appropriately inflated and deflated.

[0117] Furthermore, in this embodiment, since the pumping drive mechanism 13 has a diaphragm pump type configuration, the pressure transmission partition device 10 can have a simple configuration.

[0118] In this way, in this embodiment, a medical expansion / deflation drive device 1 can be provided that can reduce the burden on the user when a pressure abnormality occurs in the secondary piping system L2 without unnecessarily increasing the frequency of drive stoppages.

[0119] In the above-described embodiment, the driven equipment was an auxiliary circulation device such as the balloon catheter 100 for IABP. However, it goes without saying that the medical inflation / deflation drive device of the present invention can also be applied to a percutaneous ventricular assist device (PVAD) and other auxiliary circulation devices.

[0120] In addition, the pumping drive mechanism 13 is configured to switch between positive pressure and negative pressure for the fluid pressure Pi (e.g., air pressure) supplied to the driving pressure chamber 14 of the pressure transmission partition device 10 by selectively opening the positive pressure drive valve 21 and the negative pressure drive valve 26. However, it is also possible to use a fluid pressure circuit that can change the fluid pressure supplied to the driving pressure chamber 14 in the same manner as in the first embodiment, or a pump capable of controlling the discharge pressure that can change the fluid pressure supplied to the driving pressure chamber 14 in the same manner as in the first embodiment, as the expansion / contraction drive mechanism.

[0121] Furthermore, the pressure transmission partition device 10 is configured to separate the gas pressure chamber 11 and the driving pressure chamber 14 on both sides by the diaphragm 15 built into the pressure vessel 12 in a manner that allows pressure transmission between them. However, it goes without saying that the pumping drive mechanism and the pressure transmission partition device (also called a capacity limiting device or isolator) may be of other types. For example, it may be configured to generate positive and negative pressure by expanding and contracting a bellows that is closed on both ends and supply it to the inside of the balloon, or it may be possible to alternately supply positive and negative pressure to the driving pressure chamber 14 from the bellows that is driven to expand and contract.

[0122] As described above, the present invention can provide a medical expansion / deflation drive device 1 that can reduce the burden on the user without unnecessarily increasing the frequency of drive stops even if a pressure abnormality occurs in a fluid connection line for driving the expansion / deflation drive of a driven device. The present invention is useful for medical expansion / deflation drive devices in general that are suitable for driving auxiliary circulation devices. [Explanation of symbols]

[0123] 1 Medical expansion and contraction drive device 10 Pressure transmission bulkhead device (gas operation section) 11 Gas Pressure Chamber 12 Pressure Vessels 13 Pumping drive mechanism (direction switching section) 14 Driving pressure chamber 15 Diaphragm (pressure receiving member) 17 Exhaust valve (exhaust means) 21 Positive pressure valve 22 Positive pressure tank 23 Positive pressure pump 24 Regulator valve 26 Negative Pressure Driven Valve 27 Negative Pressure Tank 29 Negative Pressure Pump 30 Replenishment device 31 Gas supply source 32 Regulator valve 33 Valve (First solenoid valve) 34 Refill tank 35 Valve (Second solenoid valve) 40 Auxiliary equipment 41 Auxiliary tank (auxiliary pressure chamber) 42 Auxiliary valve 43 Purge valve 44 Vacuum Tank 51 Pressure sensor (pressure detection part) 52, 53, 54, 55 Pressure sensors 59 Gas Regulating Section 60 Controller (Abnormality release operation part) 61 Input monitoring control section 61a Pressure determination unit 61b Reference pressure measuring means (post-contraction stable pressure measuring means) 62 Information output control section 62a Information output means 62b Means of generating alarm 63 Pumping drive control unit 63a Drive control means 63b Abnormality release operation means 64 Gas replenishment control unit (gas replacement means) 65 Display output section 66 Alarm output section 71 Adjustment operation input section 72 Alarm release operation section 73 Blood Pressure Variability Measuring Device 74 Electrocardiogram 75 Drive start switch 100 Catheters (IABP balloon catheters, auxiliary circulatory devices, driven equipment) 110 Balloon 124 Catheter tube 125 Tip 126 Branch 127 Metal Tube 130 Inner tube 132 Second Port L1 Primary piping system L2 Secondary piping system (fluid connection line) P1 Reference Pressure P1j Lower limit pressure P3 Measured pressure (sequential detection of balloon internal pressure) P4 Plateau Pressure P5 Peak pressure (peak pressure when balloon is inflated) T2 Second predetermined time (positive pressure drive period) T3 Third predetermined time (negative pressure driving period) tc3 detection timing (detection timing of stable pressure after contraction) (P1), (P1´) Stable pressure after contraction (P4), (P4´) Stable pressure after expansion

Claims

1. a gas operating unit having a gas pressure chamber connected to a driven device capable of expanding and contracting, and capable of moving gas in the gas pressure chamber in an inflow direction and an outflow direction relative to the driven device in response to an input driving pressure; a direction switching unit which changes the driving pressure to switch the direction of the movement operation, and which increases the pressure in the gas pressure chamber from the stable pressure side after contraction of the driven device when the movement operation is performed in the inflow direction, and decreases the pressure in the gas pressure chamber from the stable pressure side after expansion of the driven device when the movement operation is performed in the outflow direction; a gas adjusting section having an auxiliary pressure chamber connected in communication with the gas pressure chamber in an interruptable manner, the gas adjusting section adjusting the pressure of the gas pressure chamber in accordance with a communication state between the gas pressure chamber and the auxiliary pressure chamber; a pressure detection unit that detects the pressure of the gas pressure chamber, a pressure determination unit that determines whether or not there is a pressure abnormality in a fluid connection line from inside the driven device to inside the gas pressure chamber based on detection information from the pressure detection unit; an abnormality canceling operation unit that, when it is determined by the pressure determining unit that there is a pressure abnormality in the fluid connection line, executes an abnormality canceling operation to increase the pressure in the gas pressure chamber while isolating the auxiliary pressure chamber from the gas pressure chamber; Further equipped with A medical expansion / deflation drive device characterized in that, when the pressure abnormality is resolved by the abnormality resolution operation based on the judgment result of the pressure judgment unit, the expansion and contraction drive of the driven equipment in accordance with the driving pressure input is executed, and when the pressure abnormality is not resolved by the abnormality resolution operation, the expansion and contraction drive of the driven equipment in accordance with the driving pressure input is stopped.

2. The medical inflation / deflation drive device described in claim 1, characterized in that the abnormality release operation unit has a post-deflation stable pressure measuring means for measuring the post-deflation stable pressure based on the detection information of the pressure detection unit while stopping the movement operation of the gas handling unit when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line based on the detection information of the pressure detection unit, and when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line based on the detection information of the pressure detection unit, and when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line and the pressure value measured by the post-deflation stable pressure measuring means falls within an acceptable range with respect to a predetermined reference pressure, the abnormality release operation is performed while the auxiliary pressure chamber is disconnected from the gas pressure chamber.

3. A medical expansion / deflation drive device as described in claim 1 or 2, characterized in that when the pressure determination unit determines that there is a pressure abnormality in the fluid connection line even after the abnormality removal operation unit has performed the abnormality removal operation a predetermined number of times, the medical expansion / deflation drive device has an alarm generation means which stops the expansion and deflation drive of the driven equipment in accordance with the driving pressure input and outputs a predetermined alarm.

4. a drive start switch is provided to the gas operation unit by manual operation to command the start of operation according to the drive pressure; The medical inflation / deflation drive device as described in claim 3, characterized in that the abnormality removal operation unit operates again when the drive start switch is manually operated after the specified alarm is output by the alarm generation means and the condition in which the pressure determination unit determines that there is a pressure abnormality in the fluid connection line continues.

5. A medical expansion / contraction drive device as described in any one of claims 1 to 4, characterized in that the driven equipment is an auxiliary circulation device.

6. The gas operating unit has a movable pressure-receiving member that receives the driving pressure, A medical inflation / deflation drive device as described in any one of claims 1 to 5, characterized in that the pressure-receiving member receives the driving pressure on one side and the gas pressure in the driven equipment and the gas pressure chamber on the other side.

Images