JPS642386B2 - - Google Patents

Description

Detailed Description of the Invention [Technical Field] The present invention relates to a device for driving medical equipment such as an artificial heart or an intra-aortic balloon pump, and particularly relates to a device for driving a medical device such as an artificial heart or an intra-aortic balloon pump, and particularly relates to a device for driving a medical device such as an artificial heart or an intra-aortic balloon pump. It relates to a drive device.

[Prior Art] From the viewpoint of safety, it is important for an artificial heart to be driven so as to provide blood with a pulsating flow that closely resembles the pulsation of a living heart. Various types of artificial hearts are known, such as diaphragm type, sack type, and piston type, and these are generally driven by receiving a predetermined pressure from a fluid such as air. In order to drive an artificial heart under the best conditions depending on the condition of the living body, a drive device that outputs accurate pressure according to the conditions at a predetermined timing is required. In other words, heart rate, positive pressure, negative pressure, duration of applying positive pressure and negative pressure to the artificial heart, duty ratio, etc. can all be accurately and quickly set to predetermined values. A drive device that can In conventional artificial heart drive devices, mechanical pressure reducing valves and the like are used in the positive pressure system and the negative pressure system, respectively, as means for obtaining accurate pressure. In the artificial heart drive device, the output end of the positive pressure system and the output end of the negative pressure system are connected to each other in order to alternately apply positive pressure and negative pressure to the artificial heart. For switching, solenoid valves for opening/closing control are provided at the output end of the positive pressure system and the output end of the negative pressure system, respectively. These electromagnetic valves are controlled by a control device to alternately open and close at predetermined timings according to a set heart rate. By the way, this type of artificial heart drive device has to be equipped with many devices such as a compressor, a vacuum pump, a tank (accumulator), a solenoid valve, and a control device, so the device becomes quite large. Artificial hearts are used, for example, to assist a living body's heart during surgery, but because there are many doctors and surgical instruments around the operating table during surgery, a large artificial heart drive is required during surgery. The device cannot be placed near the operating table. However, it is necessary to be able to change the heart rate of the artificial heart at any time depending on the patient's physical condition. For this reason, conventionally, the artificial heart drive device has been placed at a location away from the operating table, and the operation of the artificial heart drive device has been performed by a dedicated operating technician under the direction of a doctor.
However, in order to drive the artificial heart under optimal conditions, it is desirable for a doctor to directly operate the artificial heart drive device.

Therefore, the present applicant proposed an artificial heart drive device (Japanese Patent Application No. 57-52143) that uses a solenoid valve to adjust pressure and is equipped with a remote control device in a drive device that can electrically control various parameters. did. According to this, all necessary artificial heart drive parameters can be remotely controlled.

By the way, in this type of artificial heart drive device, positive pressure and negative pressure are applied alternately to the artificial heart, so fluid must be alternately sucked in and discharged, consuming a large amount of driving fluid. I will do it. Therefore, air is generally used as the driving fluid.

However, fluid-powered artificial hearts
Since the driving fluid and blood are separated only by a thin membrane, if the membrane of the artificial heart were to fail, there is a possibility that the driving fluid would leak through the membrane into the blood. be. In this case, if the driving fluid is air, blood will coagulate, putting the patient's life at risk. In particular, in the case of patients undergoing surgery, their physical strength is extremely low, so if even the slightest abnormality occurs in the patient's body, it becomes difficult to maintain the patient's life.

By the way, for patients with heart disease, an intra-aortic balloon pump is used in addition to the auxiliary artificial heart.
The auxiliary artificial heart and the intra-aortic balloon pump are used selectively depending on the patient's condition. Therefore,
It is desirable for this type of drive device to be able to drive both the auxiliary artificial heart and the balloon pump.
However, driving a balloon pump is difficult. For example, in the case of a balloon pump, it is necessary to change the capacity (size) of the balloon pump depending on whether the patient is an adult or a child.
As its size changes, the volume of fluid that the drive supplies to the pump must also change. If the size of the balloon pump and the capacity of the driving fluid do not match, the inflation/deflation operation of the balloon pump may become incomplete or sluggish, and the pump function may not be fully performed. If it ruptures, there is a risk that a large amount of driving fluid will flow into the living body. It is very difficult to match the capacity of this kind of drive fluid with the capacity of the balloon pump.

[Objective] An object of the present invention is to provide a medical pump drive device that can drive a medical pump safely for a living body and that can easily match the capacity of the medical pump and the capacity of the driving fluid of the drive device. do.

[Configuration] In order to achieve the above object, in the present invention,
A diaphragm is placed in the fluid drive system to airtightly separate the primary side (pressure generation side) and secondary side (medical pump side), and fluid such as air is used in the pressure generation system on the primary side. The secondary side that drives the pump is filled with a fluid that is safe for living organisms, such as helium gas. Further, a regulating member for regulating the movement range of the diaphragm and a stroke adjusting means (for example, an electric motor) for driving the regulating member and adjusting its position are provided. Furthermore, a pressure detection means for detecting the pressure of the fluid is arranged on the secondary side of the diaphragm, and the amount of fluid filled in the secondary side of the diaphragm is adjusted according to the detected secondary side pressure, and The vibration range of the diaphragm is adjusted by controlling the stroke adjustment means.

When applying positive pressure and negative pressure alternately to the primary side of the diaphragm to vibrate the diaphragm to drive fluid on the secondary side of the diaphragm, if the amount of fluid on the secondary side is constant, one vibration of the diaphragm The volume of secondary fluid delivered to the medical pump by the diaphragm depends on the oscillating stroke of the diaphragm. Therefore, when the diaphragm is moved to a position where its movement is regulated by the regulating member, the vibration stroke of the diaphragm, that is, the capacity of the fluid that drives the pump, is adjusted by changing the position of the regulating member. be able to. When the secondary pressure is saturated, the diaphragm collides with the regulating member, so the detected secondary pressure is not affected by the driving fluid pressure on the primary side, and the medical pump This corresponds to pressure changes specific to the secondary fluid due to the drive of the

By limiting the vibration range of the diaphragm so that the capacity of the fluid that drives the balloon pump matches the change in flow path volume due to inflation/deflation of the balloon pump, there is no waste in the vibration stroke of the diaphragm.
Since the rise/fall of the state change of inflation/deflation of the balloon pump becomes faster, it becomes easier to adapt the operation of the balloon pump to the pulsation rhythm of the living body. In addition, by regulating the vibration range of the diaphragm using the regulating member, even if the balloon pump ruptures, the volume of the driving fluid flowing from the balloon pump into the living body will be limited, making it safe for the living body. .

Embodiments of the present invention will be described below with reference to the drawings.

FIG. 1 shows the appearance of an artificial heart drive device 1 (which can also drive a balloon pump). Referring to FIG. 1, 1a is an operating section, 1b is a display section, and 1c is a connecting section. Tubes 2a, 2b and a remote control optical fiber cable FB0 are connected to the connection portion 1c on the right side when facing the apparatus, and a remote operation board REM is connected to the tip of the optical fiber FB0.

Artificial hearts 60L and 60R (see FIG. 4) are connected to the tubes 2a and 2b, respectively. Two optical fiber cables FB1 and FB2 are connected to the connection section on the right side when facing the device. As described below, fiber optic cable
A video camera CAM is connected to FB1,
A lighting lamp LMP is connected to FB2. Video camera CAM and LMP are artificial heart 60L, 6
It is provided to monitor the actual operating status of 0R. A monitor television TV for displaying the output of the video camera CAM is provided in the display section 1b. 3 is caster.

Figures 2a and 2b show the mechanical configuration of the remote operation board REM. This will be explained with reference to FIGS. 2a and 2b. The operation board case REa is made of synthetic resin. In order to operate the switch, there is a rectangular hole in the switch area on the top of the panel, which is covered with a thin resin sheet REb. Printed board
PWB1 and PWB2 are connected to each other and integrated. On the printed circuit boards PWB1 and PWB2, there are 17 switches SW1, B0 to B15, a battery, a speaker SP, an optical/electrical converter, and an electrical/electrical converter.
Light converters etc. are arranged.

3a and 3b show part of the artificial heart 60L and a device for monitoring its operating state. Third
This will be explained with reference to Figure a and Figure 3b. The artificial heart 60L includes 60a and 60 in the monitoring case 100.
It is screwed at part b. In this example, an optical fiber FB1 for monitoring and an optical fiber FB2 for illumination are arranged orthogonally to each other at a position perpendicular to the thickness direction of the artificial heart 60L so as to face the movable part of the artificial heart 60L. be.
Further, a reflecting mirror MR1 is arranged at a position facing the tips of the optical fibers FB1 and FB2. The tip of the optical fiber FB1 is tiltable, as is well known in general medical equipment, and this can be controlled remotely.

FIG. 4 shows the system configuration of the apparatus shown in FIG. 1. Referring to FIG. 4, 60L and 60R
is an artificial heart, and 60B is an intra-aortic balloon pump. The fluid drive unit FDU is equipped with three fluid drive output terminals, but in reality, they are the artificial heart 60L and 60R and the balloon pump 60B.
Since it is impossible to imagine a situation in which both are used at the same time, only two of them are configured to operate at the same time. The electronic control unit ECU that controls the fluid drive unit FDU includes a remote operation board REM,
Lighting lamp LMP and video camera CAM are connected. The signal output end of the video camera is connected to a monitor TV. remote operation board
The REM and the electronic control unit ECU are connected by the optical fiber cable FB0 as described above.

FIG. 5 shows the configuration of the fluid drive unit FDU shown in FIG. 4. First, to explain the outline, this unit FDU includes a compressor 71, a vacuum pump 72,
It is equipped with pneumatic control mechanisms ADUL and ADUR, gas drive mechanisms GDUL, GDURA, GDURB, a helium gas tank HTA, and a pressure reducing valve 61.
The input end of the gas drive mechanism GDUL is a pneumatic control mechanism.
It is connected to the output end of ADUL, and the input ends of gas drive mechanisms GDURA and GDURB are commonly connected to the output end of pneumatic control mechanism ADUR.
The output ends of the gas drive mechanisms GDUL, GDURA, and GDURB are connected to the artificial hearts 60L, 60R and the balloon pump 60B, respectively.

The pneumatic control mechanism ADUL will be explained. This mechanism includes six solenoid valves 51, 52, 53, 54, 5.
5 and 56 are provided. Solenoid valves 51, 52
and 53 are used for positive pressure generation, and solenoid valve 5
4, 55 and 56 are used for negative pressure generation.
Solenoid valves 51 and 52 are accumulator AC1
The electromagnetic valves 54 and 55 are provided inside the accumulator AC2.
The input ends of the solenoid valves 51 and 53 are connected to the compressor 7.
The input ends of the solenoid valves 54 and 56 (on the downstream side in terms of the fluid flow direction) are connected to the negative pressure output end of the vacuum pump 72, and the solenoid valves 52, 53, 55 are connected to the negative pressure output end of the vacuum pump 72. and 56 are connected to the output end of the pneumatic control mechanism ADUL. PS1 and PS2 are pressure sensors for detecting the pressure inside the accumulators AC1 and AC2, respectively. Air pressure control mechanism
The configuration of ADUR is the same as ADUL.

Next, the gas drive mechanism GDUL will be explained. This mechanism is equipped with electromagnetic valves 57, 58, 59, a fluid isolator AGA, and the like. Mechanical valve VA1 is installed on the primary side (air side) of the fluid isolator AGA.
The output end of the air pressure control mechanism ADUL is connected via the air pressure control mechanism ADUL. The solenoid valve 57 has an input end connected to the primary side of the fluid isolator AGA, and an output end open to the atmosphere. The input end of the electromagnetic valve 59 is connected to the output end of the pressure reducing valve 61, and the output end is connected to the secondary side of the fluid isolator AGA. The solenoid valve 58 has an input end connected to the secondary side of the fluid isolator AGA, and an output end connected to the accumulator AC.
Connected to the inside of 2. fluid isolator
Pressure sensors PS3 and PS4 are provided on the primary and secondary sides of the AGA, respectively. The configuration of the gas drive mechanism GDURA and GDURB is GDUL
It is similar to

FIG. 6 shows the configuration of the fluid isolator AGA included in the gas drive mechanism GDURB. This will be explained with reference to FIG. Simply put, in the AGA, a diaphragm 83 sandwiched between housings 81 and 82 separates a space communicating with the primary port 81a and a space communicating with the secondary port 82a. It is becoming possible to shift.

A plate 84 is provided at the center of the diaphragm 83.
and 85 are attached to sandwich it.
86 is a bolt for fixing the plates 85 and 86. A regulating member 63 for adjusting the amount of deviation of the plate 85 is attached to the center of the housing 81 . The regulating member 63 is formed with screws 63a and 63b, and is engaged with the housing 81 at the screw 63b.

When the regulating member 63 is rotated, the engagement position changes and the regulating member 63 moves left and right. If they move to the left, the range of movement of the plates 84, 85 becomes larger, and if they move to the right, the range of movement of the plates 84, 85 becomes smaller. M1 is a DC motor. A worm gear 62 is coupled to the drive shaft of the DC motor M1, and the worm gear 62 meshes with a screw 63a. Therefore, by driving the motor M1, the movement range of the plates 84, 85 changes. The motor M1 is connected to the base plate 90
It is fixed to the flange portion 81b of the housing 81 via. 89 is O-ring, 87 and 88
is a bolt for fixing the housings 81 and 82.

The fluid isolator AGA provided in the gas drive mechanisms GDUL and GDURA has the same configuration as that shown in FIG. 6, except that the motor M1 is omitted.

Solenoid valves 51, 52, 5 used in this example
3, 54, 55, 56, 57, 58 and 59
All have the same configuration. one of them
7a, 7b, 7c and 7.
They are shown in Figure d. Figure 7a, Figure 7b, Figure 7
This will be explained with reference to FIG. c and FIG. 7d. A first port 12 and a second port 13 are formed in a valve housing 11 of the solenoid valve. The inner space of the housing 11 is divided by the valve seat 14 into a first inner chamber 15 communicating with the first port 12 and a second inner chamber 16 communicating with the second port 13 . A magnetic coil case 18 is fixed to the valve housing 11 with a sealing material 17 interposed therebetween.

A coil bobbin 20 having a coil 19 wound thereon is inserted into the case 18, and is supported by magnetic bases 21 and 22. A fixed magnetic core 23 is fixed to the base 21 . The core 23 is hollow, and a non-magnetic guide rod 24 passes through it. The rod 24 has a movable magnetic core 2.
5 is fixed. One end of the rod 24 is pushed to the left by a coil spring 26. rod 2
The other end of 4 passes through the bearing 27 and the bellows 28, and a valve body 29 is fixed to the end. The inner space of the bellows 28 is connected to the first inner chamber 15 (as shown) or the second inner chamber 1 through the small holes 30 and 37.
6 (when the rod 24 is driven to the right).

When coil 19 is energized, core 23 - core 2
5-Base 22-Case 18-Base 21-Core 23 generates a circulating magnetic flux, and the core 25 and core 23
The rod 24 moves to the right to the point where this suction force and the repulsive force of the coil spring 26 are balanced, and the valve body 29 moves away from the valve seat 14 in response to the suction force. distance away. core 23
The end surface 23a of the core 25 is in the shape of a chevron, and the end surface 25a of the core 25 is concave to receive the central protrusion, and the inner surfaces 23b of the chevron-shaped protrusions at both ends are tapered. Due to the existence of this taper, the energization level and the amount of movement of the rod 24 (the gap between 23a and 25a) are in a proportional relationship over a wide range. Furthermore, this type of solenoid valve has a movable part that has good responsiveness and can perform opening/closing control at high speed.

Figure 8 shows the electronic control unit shown in Figure 4.
The configuration of the ECU is shown. Referring to FIG. 8, the electronic control unit ECU includes control units CON1,
CON2 and CON3, remote control receiving unit
SRU, main unit side operation board MOB, display unit
DSPU and scope & lamp control unit
I'm getting used to it at SLCU.

Control unit CON1 is a pneumatic control mechanism
ADUL and ADUR pressure sensors PS1 and PS
By monitoring the output signal of 2, the accumulator AC
The solenoid valves 51 and 52 are controlled to open and close so that the pressure inside AC 1 and AC 2 matches the set pressure.

Control unit CON2 is a pneumatic control mechanism
ADUL and ADUR solenoid valves 52, 53, 55
and 56 are controlled to open and close at predetermined timings according to the set heartbeat cycle, the left and right durations (or duty), and the like.

The control unit CON3 has a gas drive mechanism GDUL,
Controls GDURA and GDURB solenoid valves 57, 58 and 59. However, GDURA and GDURB are not controlled at the same time. GDUL and GDURA are controlled by monitoring the output signals (PG1, PG2) of pressure sensors PS3 and PS4, but GDURB
In this control, the output signal of the pressure sensor PS3 is not monitored. In addition, in controlling GDURB, motor M
Control 1.

The display unit DSPU consists of a large number of 7-segment displays, and the control units CON1 and CON
2 and CON3. The main unit side operation board MOB is the control unit CON1, CON2,
CON3 and scope & lamp control unit
Connected to SLCU. Each output line of the remote control receiving unit SRU is connected in the same way as the corresponding signal line of the main body side operation board MOB.

FIG. 9 shows details of the control unit CON1 of FIG. 8. This will be explained with reference to FIG. This control unit CON1 is mainly composed of a microcomputer unit CPU1. Connector J1, to which the main unit side operation board MOB and remote control receiving unit SRU are connected, is a buffer
It is connected to the input port of CPU1 via BF1 and chattering removal circuit CH1. The signals applied to connector J1 are R side (right side) positive pressure UP, R side positive pressure DOWN, R side negative pressure UP, R side negative pressure DOWN, L side (left side) positive pressure UP, L side positive pressure.
This is an instruction signal for pressure setting such as DOWN, L side negative pressure UP, and L side negative pressure DOWN.

Buffer Z1 is connected to the four output ports of CPU1.
5 through each solid state relay SSR
1, SSR2, SSR3 and SSR4 are connected, and each solid state relay SSR1 to SSR
The output end of 4 is connected to the solenoid valves 51 (L, R) and 54.
(L,R).

Z16 is an A/D (analog/digital) converter. This A/D converter Z16 has eight input channels, four of which are used in this embodiment. Signal RPP, RNP,
LPP and LNP are from pressure sensors that detect right side positive pressure, right side negative pressure, left side positive pressure and left side negative pressure, respectively. The display output port of CPU1 is connected to the display driver DDV1,
The output end of DDV1 is connected to the display unit DSPU.

FIG. 10 shows the configuration of the control unit CON2 of FIG. 8. This will be explained with reference to FIG. This control unit CON2 is mainly composed of a microcomputer unit CPU2. A connector J8 to which the main unit side operation board MOB and remote control receiving unit SRU are connected is connected to the input port of the CPU 2 via a buffer BF2 and a chattering removal circuit CH2.

The signals applied to connector J8 are heart rate UP,
These are setting instruction signals such as heart rate DOWN, R side duty UP, R side duty DOWN, L side duty UP, and L side duty DOWN. CPU2 8
Two output ports, buffer Z15B, Z15C
respectively through solid state relay SSR
5 to SSR12 are connected. Solid state relays SSR5 to SSR8 are solenoid valves 5 for applying air pressure.
2 (L, R) and 55 (L, R), respectively, and SSR9 to SSR12 are connected to air pressure compensation solenoid valves 53 (L, R) and 56 (L, R), respectively. A display driver DDV2 is connected to the display signal output port of the CPU2, and a display unit DSPU is connected to the output end of the DDV2.

FIG. 11 shows the configuration of the control unit CON3 of FIG. 8. This will be explained with reference to FIG. This unit CON3 is mainly composed of a microcomputer unit CPU3. Main unit side operation board MOB and remote control receiving unit
Connector J12 to which the SRU is connected is a buffer
It is connected to the input port of CPU3 via BF3 and chattering removal circuit CH3. Signals applied to the connector J12 include an air purge instruction signal, an auxiliary heart/balloon pump selection signal, etc. from the main body side operation board MOB.

An A/D converter Z16B with the same configuration as Z16 is connected to CPU3, and gas drive mechanisms GDUL and GDURA are connected to the analog signal input terminal of Z16B.
And the output terminal of the pressure sensor equipped on GDURB is connected. MD1 is a circuit for driving the stroke adjustment motor M1. MD1-2
By controlling two input terminals, motor M1
Can be controlled to rotate forward, reverse or stop.

Buffer Z1 is installed on the nine output ports of CPU3.
Solid state relays SSR13 to SSR21 are connected via 5D, Z15E and Z15F. The output terminals of SSR13, SSR14 and SSR15 are connected to the gas drive mechanism GDUL, respectively.
It is connected to the solenoid valves 57 of GDURA and GDURB, and the output terminals of SSR16, SSR17 and SSR18 are connected to the gas drive mechanism GDUL, respectively.
It is connected to the solenoid valves 59 of GDURA and GDURB, and the output terminals of SSR19, SSR20 and SSR21 are connected to the gas drive mechanism GDUL, respectively.
It is connected to the GDURA and GDURB solenoid valves 58.

FIG. 12 shows the configuration of the scope and lamp control unit SLCU shown in FIG. 8. This unit SCLU
is buffer BF4, solid state relay
SSR22, SSR23, inverter IN1, IN2,
AC/DC converter (i.e. DC power supply) POW
1, POW2, etc., and the output terminal of SSR22 is connected to the lighting lamp LMP, and the output terminal of POW1 is connected to the video camera CAM. POW
2 is buffer BF4, inverter IN1, IN2,
Solid state relay SSR22 and SSR23
Generates DC voltage to control.

Figure 13 shows the main body side operation board MOB in Figure 8.
The configuration is shown below. This will be explained with reference to FIG. The main unit side operation board MOB has 20 switches S0~
It is connected to S19 and resistor array REA. The switches S0 to S15 each perform the same functions as the switches B0 to B15 provided on the remote operation board REM. The functions of each switch S0 to S19 are remote ON/OFF (whether to enable REM), temporary stop (solenoid valve 52,
53, 55 and 56), L side positive pressure UP, R side positive pressure UP, L side positive pressure DOWN, R side positive pressure DOWN, L side negative pressure UP, R side negative pressure UP, L side negative Pressure DOWN, R side negative pressure DOWN, L side duty
UP, R side duty UP, L side duty
DOWN, R side duty DOWN, heart rate UP,
Heart rate down, video camera on, light on,
These are an air venting instruction and an auxiliary heart/balloon selection instruction.

Figure 14 shows the remote control receiving unit in Figure 8.
Figure 15 shows the circuit configuration of the SRU, and the circuit configuration of the remote operation board REM connected to it.
First, refer to Figure 15 and install the remote operation board.
Explain REM.

Z9 is an integrated circuit for transmitting remote control signals (M58484P manufactured by Mitsubishi Electric). This integrated circuit Z9 is
Roughly speaking, it is equipped with a key scan signal generation circuit, a key input encoder, a command decoder, an oscillation circuit, a timing generation circuit, a code modulation circuit, an output buffer, etc., and monitors the 6 x 5 key matrix input terminals to generate 30 types. It also outputs 6-bit PCM serial code data according to the instruction.

Integrated circuit Z9 key scan output terminals φa, φb,
Sixteen key switches B0 to B15 are connected in a matrix to φc, φd and φe and key input terminals I ₁ , I ₂ , I ₃ and I ₄ . Z9 power terminal
A battery is connected to Vcc via a power switch SW1. This power supply line includes a light emitting diode D1 for power on/off indication, voltage stabilizing capacitors C1 and C2, an integrated circuit Z10,
A light emitting diode D3 and the like for displaying a voltage drop is connected.

The integrated circuit Z10 is for voltage drop monitoring, and in this example, lights up the light emitting diode D3 when the voltage Vcc falls below 4.3V. Integrated circuit Z1 is connected to the signal output terminal OUT of integrated circuit Z9 via logic gate G8.
1 is connected. The integrated circuit Z11 is electrical/
It is a light conversion module (Toshiba TOTX70),
It emits light according to the electrical signal applied to input terminal A.

One end of the optical fiber cable FB0 is connected to the optical output terminal of the integrated circuit Z11. The optical fiber cable FB0 is made up of two sets of optical fibers, and the other optical fiber of FB0 is connected to the optical input terminal of the integrated circuit Z12. Integrated circuit Z12
is an optical/electrical conversion module (Toshiba TORX70)
It is. A logic gate G9 is connected to the electrical signal output terminal B of the integrated circuit Z12 via a logic gate G11.
and G10 are connected. logic gate G9
A light emitting diode D2 is connected to the output terminal of the logic gate G10, and a speaker SP is connected to the output terminal of the logic gate G10 via a capacitor C8.

Next, the remote control receiving unit SRC will be explained with reference to FIG. Z3 is an integrated circuit for receiving remote control signals (M58481P manufactured by Mitsubishi Electric).
Roughly speaking, this integrated circuit Z3 includes an input circuit,
Demodulation circuit, instruction decoder, timing generation circuit,
It is equipped with a channel control circuit, an oscillation circuit, a flip-flop, etc., and demodulates and decodes the signal applied to the transmission signal input terminal SI, and sends the results to the output terminals P ₀ , P ₁ , P ₂ , P ₃ , IR, Set to Power ON/OFF, etc. The output terminal IR outputs a signal indicating whether a signal has been received, that is, whether a key input has been made on the transmitting side. Output terminal
The Power ON/OFF signal level is set or reset when a predetermined signal (corresponding to the operation of switch B0 on the REM side) is received. This terminal is used here to control whether or not to enable remote control.

Integrated circuits Z1 and Z2 are connected to each set of fibers of optical fiber cable FB0.
Integrated circuit Z1 is an optical/electrical conversion module (Z12
), and its optical input terminal is connected to the optical output terminal of the integrated circuit Z11 via FB0. Integrated circuit Z2 is an electrical/optical conversion module (same as Z11), and its optical output terminal is FB
0 to the optical input terminal of the integrated circuit Z12.

The received optical signal is converted into an electrical signal and Z
From output terminal B of 1, via logic gate G1,
It is applied to the signal input terminal SI of the integrated circuit Z3. Integrated circuit Z4 is a D-type flip-flop, and Z5 is a decoder (74159). The 4-bit code data obtained at the output terminals _P0 to _P3 of the integrated circuit Z3 is decoded into 15 types of instruction signals by the decoder Z5 and supplied to each circuit via the connector CN1. The decoder Z5 has an open collector output, and each of these output lines is wired-OR connected to the corresponding signal line of the operation board MOB on the main body side.

The level of the output terminal PowerON/OFF of the integrated circuit Z3 changes to flip-flop Z every time an optical signal is received.
4 and this output signal is applied to the gate input terminal G2 of decoder Z5, so that when remote control is set to disabled, decoder Z5 will not output a signal (transistor on).

Integrated circuits Z6, Z7 and Z8 are programmable pulse generators (8640 manufactured by Suwa Seikosha).
Roughly speaking, these pulse generators are equipped with a crystal oscillator, programmable divider, etc. inside, and CTL1 to CTL6 are frequency setting terminals and OUT
is the output terminal and EXC is the external clock input terminal. In this example, when an optical signal is received while remote control is enabled, integrated circuits Z6, Z7 and Z8 are reset and output a pulse signal.

When the reset is released, Z8 sends a relatively long periodic pulse signal to the frequency control terminal of Z7.
Apply to CTL2. Also, the signal from the output terminal _P3 of Z3 is transmitted to the frequency control terminal CTL1 and the frequency control terminal of Z6.
Applied to CTL3. In this example, the transmission codes are classified according to the control parameters UP/DOWN, and when the switch on the UP side of the remote control board is operated, and when the switch on the DOWN side is operated, The signal level obtained at the output terminal _P3 of is different.

Therefore, the type of switch (UP/DOWN)
The frequency division ratio of integrated circuit Z6 changes accordingly. As a result, in this example, if there is a parameter change instruction or a pause instruction on the UP side, 3.3KHz and 1.75K
Hz signal appears alternately at predetermined time intervals, DOWN
If there is an instruction to change the parameter on the side, it will be 1.70KHz.
0.85KHz signals appear alternately. This signal is
It is applied from the output terminal OUT of integrated circuit Z7 to integrated circuit Z2 via logic gates G5 and G4. In other words, when a switch is operated on the remote operation board REM, the signal corresponding to that switch is
It is transmitted as an optical signal from the remote control receiving unit SRU to the remote operation board REM.

This optical signal is converted into an electrical signal at Z12,
Through logic gates G11, G9 and G10,
Activate the light emitting diode D2 and the speaker SP. Therefore, on the remote operation board REM side,
Whether remote control is being performed using light and sound.
You can check whether you are operating either the UP or DOWN switch.

Figures 16a and 16b schematically show the operation of the microcomputer unit CPU1. FIG. 16a shows the main routine, and FIG. 16b shows the interrupt processing routine. This will be explained with reference to FIGS. 16a and 16b.

When the power is turned on, the output port is first set to the initial level, the contents of the read/write memory (RAM) are cleared, the pre-stored data in the read-only memory (ROM) is read, and the parameters are set to initial values. The parameters of CPU1 are right side positive pressure target value P1, right side negative pressure target value P2,
There are a left side positive pressure target value P3, a left side negative pressure target value P4, etc. In this example, pressures P1, P2, P3 and P4 are used.
The initial values of +30, -30, +100 and -
It is set to 50 [mmHg].

Also, after this processing, interrupts are enabled. In this example, an internal timer causes interrupts to occur periodically at a cycle of 4 msec. After waiting for an interrupt, pressure data is sampled.

Check the sampled pressure data and determine whether there is abnormal data. That is, if the detected pressure is abnormally different from the target value, it is regarded as abnormal. In addition, in this embodiment, solenoid valves 53 and 56 are provided for pressure compensation, and the pressure may become relatively large temporarily, but each pressure data is averaged by sampling multiple times. By doing this, I try to mask this.

In the unlikely event that an abnormality occurs, the abnormal data is converted to numerical code data, and this data and abnormality display data indicating the part where the abnormality has occurred are displayed on the display unit.
Output to DSPU and display.

If there is no abnormality, it averages the past m pressure data stored in the read/write memory, converts the averaged data into a numerical code, and sends the code data to the display unit DSPU. Main unit side operation board
When there is a key operation on MOB or remote operation board REM, depending on the key operated, right side positive pressure target pressure P1, right side negative pressure target pressure P2, left side positive pressure target pressure P3, or left side negative pressure target pressure P4 The value of is updated in predetermined steps. However, upper and lower limits are set, and pressure settings that exceed these limits are not possible.

The interrupt processing in FIG. 16b will be explained. First, check the positive pressure RPP of the right artificial heart drive system. If the pressure is lower than the predetermined pressure P1, the pressure regulating valve 51R is set to open; otherwise, the pressure regulating valve 51R is set to open.
Set R to closed. Next, check the negative pressure RNP of the right artificial heart drive system. If the value (absolute value) of RPN is smaller than P2, the pressure regulating valve 54R is set to open; otherwise, the pressure regulating valve 54R is set to closed. Next, compare the positive pressure LPP and negative pressure LNP on the left side with P3 and P4, respectively.
Set pressure regulating valves 51L and 54L to open or close. That is, in this embodiment, the pressure regulating valve 51 or 54 is opened only when the detected pressure (absolute value) becomes smaller than the target pressure.

A schematic operation of the microcomputer unit CPU2 is shown in FIGS. 17a and 17b. FIG. 17a shows the main routine, and FIG. 17b shows the interrupt processing routine. This will be explained with reference to FIGS. 17a and 17b.

When the power is turned on, the microcomputer
CPU2 sets the output port to the initial level,
Clear the contents of the read/write memory (RAM), read the values previously stored in the read-only memory (ROM), and set the initial values to the parameters. The parameters of CPU2 are heart rate PR,
There are duty DL for the left artificial heart, duty DR for the right artificial heart, etc. In this example, the initial values are PR 100 rpm and DL 45% (duration 270 m).
s) and DR is set to 55% (duration time 330ms).

Next, a processing loop including processing such as waiting for an interrupt, checking key input from the operation board, and displaying parameters is executed. If there is a key input, the type of input key is determined, the desired parameter change value is compared with the upper limit value and the lower limit value, and calculations are performed to perform calculation processing on parameters related to the changed parameter. These processes are performed while executing various subroutines.

Interrupt processing will be explained. Counter COR and
The value of COL is incremented by one each time an interrupt is processed. Also, the count value
When PR (time parameter determined by heart rate) is reached, each count value is cleared to 0. When the value of the counter COR becomes 0, the valve 52R,
53R and 55R are set to open, open and closed (positive pressure application mode), respectively. Counter COR
When the value becomes the reference value Ref1 (a value regulating the opening time of the positive pressure compensation solenoid valve 53), the solenoid valve 53R is set to close. When the value of the counter COR reaches the duty parameter value DR, the valves 55R, 56R, and 52R are set to open, open, and closed (negative pressure application mode), respectively. The value of counter COR is
When Ref2 (a value regulating the opening time of the negative pressure compensation solenoid valve 56) is reached, the solenoid valve 56R is set to close.
After this processing, the counter COR is counted up.

Similarly, when the value of the counter COL becomes 0, the valves 52L, 53L, and 55L are set to open, open, and closed (positive pressure application mode), respectively, and the value of COL becomes the reference value Ref1 (positive pressure compensation solenoid valve 53 When the value that regulates the opening time of COL is reached, the solenoid valve 53L is set to close and the value of COL becomes the value of the duty parameter.
When DL is reached, valves 55L, 56L, and 52L are set to open, open, and closed (negative pressure application mode), respectively, and the value of COL is set to Ref2 (negative pressure compensation solenoid valve 56).
When the value regulating the opening time of solenoid valve 56L is reached, the solenoid valve 56L
Set COL to close and count up COL.
That is, as shown in FIG. 19a, the solenoid valves 52, 5
3, 55 and 56 are activated. After switching from negative pressure to positive pressure, the solenoid valve 53 is temporarily opened, and after switching from positive pressure to negative pressure, the solenoid valve 56 is temporarily opened, so that the pressure rises. The fall becomes steep and the pressure waveform becomes a square wave. Note that the solenoid valve 56 may be omitted because the speed at which the pressure is switched from positive pressure to negative pressure (falling) does not have a large effect on the drive of the artificial heart. Although not shown in FIGS. 17a and 17, when there is a temporary stop instruction (S1 or B1 is on), the solenoid valves 52 and 5
3, 55 and 56 are stopped.

Figures 18a and 18b schematically show the operation of the microcomputer unit CPU3. FIG. 18a is the main routine, and FIG. 18b is the air purge subroutine.

First, explanation will be given with reference to FIG. 18a. When the power is turned on, the memory and output port are initialized, and a check is made to see if there is an air venting instruction (S18 on). If there is an instruction, an air venting subroutine to be described later is executed. The state of switch S19 is checked to determine whether the right drive system is in auxiliary heart mode or balloon pump mode.

In case of cardiac assist mode, pressure sensor PS3 and PS
Read the output signals PG1 and PG2 of 4. When the level of PG1 is higher than PG2 by a predetermined value Ref3, the solenoid valve 59 is set open and helium gas is supplied from the helium tank HTA to the secondary side of the fluid isolator AGA. Since a relatively high pressure (for example, 150 mmHg) appears in the output of the pressure reducing valve 61, opening the solenoid valve 59 increases the pressure on the secondary side of the AGA.

If the difference between PG1 and PG2 is less than Ref3, the solenoid valve 59 is set to close. Also, the level of PG2
If Ref4 or more is greater than PG1, the solenoid valve 58 is set open to reduce the secondary pressure of the AGA.
If the difference between PG1 and PG2 is less than a predetermined value, the solenoid valve 58 is set to close.

The operation timing of the auxiliary heart mode was changed to the 19th c.
As shown in the figure. Normally, the plates 84, 85 (and diaphragm 83) of the fluid isolator AGA vibrate in response to pressure changes from the air pressure control mechanism without hitting the housings 81, 82 or the regulating member 63. In this state, there is no large difference in pressure between the primary and secondary sides of the fluid isolator AGA.

However, if a fluid leak occurs on the secondary side of the fluid isolator AGA (helium gas leaks to the atmosphere side), the pressure on the secondary side decreases, and the plates 84, 8
The vibration position of No. 5 moves to the right in FIG.
When the movement exceeds a predetermined value, the plate 84 comes into contact with the housing 82. When plate 84 contacts housing 82, fluid isolator AGA
Since the fluid pressure on the secondary side of will not increase any further, 1
A difference occurs between the pressure PG1 on the next side and the pressure PG2 on the secondary side.

Further, after the solenoid valve 59 is opened, the secondary side pressure PG2 of the AGA increases, and the vibration positions of the plates 84 and 85 move to the left in FIG. 63 or the housing 81, and PG1<PG2. Therefore, by controlling the solenoid valves 58 and 59 so that the difference between PG1 and PG2 is maintained below a predetermined value as described above, the secondary side pressure PG2 is maintained within a predetermined range, and the plates 84, 85 are can be driven so that the vibration does not stop.

When switch S19 is set to the balloon pump side, the balloon mode is entered. Roughly speaking, in the balloon mode, only the secondary pressure PG2 is monitored, and the solenoid valves 58, 59 and 85 are operated so that the strokes of the plates 84 and 85 vibrate within the position range regulated by the housing 82 and the regulating member 63. Controls motor M1.

In this mode, the pressure PG2 has a waveform as shown in Figure 19b. That is, when the driving pressure changes from negative pressure to positive pressure, a pressure equal to PG1 appears at PG2, and the pressure drops (saturates) when the plate 84 contacts the housing 82. Further, when the driving pressure changes from positive pressure to negative pressure, a pressure equal to PG1 appears at PG2, and the pressure increases (the absolute value decreases) (saturation) when the plate 85 contacts the regulating member 63.

Returning to Fig. 18a, first, the difference between the upper and lower saturation pressures of PG2, that is, the difference in Fig. 19b.
Ask for PST. PST corresponds to the movement range (stroke) of the plates 84 and 85. If PST is larger than the stroke upper limit, the motor M1 is driven in normal rotation to drive the regulating member 63 to the right in FIG. 6, and if PST is smaller than the stroke lower limit,
The motor M1 is driven in reverse to move the regulating member 63 to the sixth position.
Drive to the left in the figure. In this way, the strokes of the plates 84, 85 are first adjusted within a predetermined range.

There is a reason for making stroke adjustments. One is that the capacity of the balloon pump differs depending on the patient (adult, child, etc.), so when driving a small-capacity balloon pump, the stroke should be shortened to eliminate unnecessary movement. This is to make it easier to move the balloon pump, and the other is to limit the amount of gas flowing out in the event that the balloon pump ruptures.

Next, the negative side saturation pressure PG2L (absolute value) is compared with a predetermined upper and lower limit value. PG2L
If the value is larger than the upper limit, the solenoid valve 59 is set to open, and if it is smaller than the upper limit, the solenoid valve 59 is set to closed. If PG2L is smaller than the lower limit, the solenoid valve 58 is set to open, and if it is larger than the lower limit, the solenoid valve 58 is set to close. This results in
PG2L is maintained between the upper limit value and the lower limit value, and is controlled so that the amount of helium gas on the secondary side of the fluid isolator AGA does not change significantly.

Next, the air venting operation will be explained. Switch S18
When turned on, the air purge subroutine is executed. This will be explained with reference to FIG. 18b. In this example, first, the solenoid valves 57R and 57L are opened to open the primary side of the fluid isolator AGA to the atmosphere. Then,
Set the counter COX (internal register) to a predetermined value (10 in this example). Clear and start the timer, close solenoid valve 58, and set solenoid valve 59 to open. When the timer times out, after clearing and starting the timer, the solenoid valve 58 is opened, and the solenoid valve 59 is opened.
Set each to closed. When the timer times out, it decrements the counter COX and
If COX is not 0, repeat the above operation.

In other words, every predetermined time set in the timer,
The solenoid valves 58 and 59 are repeatedly opened, closed, and closed and opened. Therefore, since positive and negative pressures are alternately applied to the secondary side of the fluid isolator AGA, and since the primary side of the fluid isolator AGA is at atmospheric pressure, the plates 84 and 85 are connected to the housing 8.
As a result, a large amount of fluid flows in and out of the flow path on the secondary side of the AGA, and the fluid inside gradually changes from air to helium gas. Changes to

Therefore, balloon pump 60 in a normal room
Even if the tube B is attached to the main body of the drive device, air can be removed from the secondary side of the fluid isolator AGA with a simple switch operation.

In the above embodiment, the fluid isolator
In order to remove air from the secondary side of the AGA,
A solenoid valve 57 is provided on the next side, and the solenoid valve 57 is synchronized with the solenoid valves 52 and 55 of the pneumatic control mechanism.
If 8 and 59 are controlled to open and close, the solenoid valve 57 is not necessary. The operation timing in that case is shown in FIG. That is, at the timing when the solenoid valve 52 is opened and positive pressure is applied to the primary side of the AGA, the solenoid valve 58 is opened.
is opened to drive the plates 84 and 85 to the secondary side,
At the timing when the solenoid valve 55 is opened to apply negative pressure to the primary side of the AGA, the solenoid valve 59 is opened and the plate 8 is opened.
4 and 85 should be driven to the secondary side of the AGA.

Figures 21a and 21b and 22
Figures a and 22b show an embodiment in which the mounting positions of the optical fiber FB1 connected to the video camera and the optical fiber FB2 connected to the illumination lamp are changed.

In the embodiment, a case has been described in which an artificial heart or the like is driven by helium gas, but instead of this, for example, carbon dioxide gas may be used.

[Effect] In the embodiment described above, in the balloon mode, the vibration range of the movable part of the fluid isolator is regulated by the regulating member, and the regulated range is adjusted to match the drive capacity of the medical pump used. Therefore, the following effects can be obtained.

(1) Since there is no waste in the vibration stroke of the fluid isolator's diaphragm in response to changes in fluid volume due to the expansion/deflation of the medical pump, the diaphragm can be vibrated in the minimum amount of time, and the expansion/deflation of the medical pump is minimized. /Since the rise and fall of the contraction operation can be performed quickly, it is easy to match the operation of the medical pump to the pulsation rhythm of the living body.

(2) Since the vibration range of the diaphragm of the fluid isolator is regulated by the regulating member, even if a very high pressure is applied to the primary side of the diaphragm, the pressure increase on the secondary side is limited. Therefore, even if the medical pump ruptures, there is no fear that a large amount of the driving fluid inside the pump will flow into the living body, making it extremely safe.

In addition, in the balloon mode, the movement range of the diaphragm is regulated by the regulating member, so when the diaphragm is in contact with the regulating member, the volume of the fluid isolator secondary space is constant; The amount of fluid filling the downstream space determines the pressure applied to the medical pump. In the present invention, the opening and closing of the gas supply valve means and the gas discharge valve means are controlled so that the detected saturation pressure on the secondary side of the fluid isolator (the pressure when the diaphragm is in contact with the regulating member) becomes the set pressure. Since the fluid volume is adjusted,
The internal pressure of the medical pump in a state where the diaphragm is in contact with the regulating member can be set to a value equivalent to the blood pressure required for a living body.

[Brief explanation of the drawing]

FIG. 1 is a perspective view showing the main body of one type of artificial heart drive device embodying the present invention. Figures 2a and 2b are remote operation boards, respectively.
FIG. 3 is a plan view and a front view showing the REM. 3rd a
The figure is a plan view showing an artificial heart 60L equipped with optical fibers FB1, FB2, etc., and FIG. 3b is a sectional view taken along the line bb in FIG. 3a. FIG. 4 is a block diagram showing the system configuration of the apparatus shown in FIG. 1.
FIG. 5 is a block diagram showing the configuration of the fluid drive unit FDU of FIG. 4. FIG. 6 is a longitudinal sectional view showing the configuration of the fluid isolator AGA provided in the gas drive mechanism GDURB of FIG. 5. Figure 7a,
FIGS. 7b, 7c, and 7d are a plan view, a right side view, a left side view, and an enlarged longitudinal cross-sectional view, respectively, showing the configuration of the electromagnetic valve used in the example. Figure 8 shows the electronic control unit ECU in Figure 4.
FIG. Figures 9 and 10
1 and 11 are block diagrams showing the configurations of control units CON1, CON2 and CON3 of FIG. 8, respectively. FIG. 12 is a block diagram showing the configuration of the scope and lamp control unit SLCU shown in FIG. 8. FIG. 13 is an electric circuit diagram showing the configuration of the main body side operation board MOB shown in FIG. 8. FIG. 14 is an electrical circuit diagram showing the configuration of the remote control receiving unit SRU shown in FIG. 8.
FIG. 15 is an electrical circuit diagram showing the configuration of the remote operation board REM. Figures 16a and 16
FIG. b is a flowchart showing the general operation of the CPU 1 in FIG. 9. FIGS. 17a and 17b are flowcharts showing the general operation of the CPU 2 in FIG. 10. FIGS. 18a and 18b are flowcharts showing the general operation of the CPU 3 in FIG. 11. FIGS. 19a, 19b, and 19c are waveform diagrams showing the operating timing of the device. FIG. 20 is a waveform diagram showing operation timing in another embodiment of the present invention. 21st
Figures a and 21b are a longitudinal cross-sectional view and a cross-sectional view showing the attachment positions of the artificial heart and the optical fibers FB1 and FB2 in one modification. 22nd a
Figure 22b is a longitudinal cross-sectional view and a cross-sectional view showing the attachment positions of the artificial heart and the optical fibers FB1 and FB2 in another modified example. 1: Artificial heart drive device, 2a, 2b: Tube, 58: Solenoid valve (gas discharge valve means), 59: Solenoid valve (gas supply valve means), 60L, 60R: Artificial heart, 60B: Intra-aortic balloon pump (medical pump), 63c, 82: (regulating member), 71: compressor, 72: vacuum pump, ADUL,
ADUR: Air pressure control mechanism (first pressure adjustment device), GDUL, GDURA, GDURB: Gas drive mechanism (second pressure adjustment device), AGA: Fluid isolator (medical pump drive means), M1: Electric motor (stroke adjustment PS4: Pressure sensor (pressure detection means), HTA: Helium tank (gas supply means), ECU: Electronic control unit (electronic control means).

Claims (1)

[Claims] 1. A first pressure regulating device that alternately outputs positive pressure and negative pressure to its output end; A medical pump driving means that separates the side and the secondary side, a regulating member that regulates the deviation range of the separating member, a pressure detecting means arranged on the secondary side of the medical pump driving means, and a gas that supplies an inert gas. supply means, gas supply valve means connected between the secondary side of the medical pump drive means and the gas supply means;
and a gas discharge valve means having one end connected to the secondary side of the medical pump driving means and the other end connected to a negative pressure source, the primary side of the medical pump driving means being connected to the output end of the first pressure regulating device. a second pressure regulating device in which the secondary side of the medical pump driving means is connected to the driving fluid chamber of the medical pump; a stroke adjusting device that drives the regulating member and adjusts its position; and an output of the pressure detecting means. The secondary side pressure of the medical pump driving means is detected by monitoring the electrical signal generated by the medical pump, and the differential pressure between the detected saturated pressure on the positive pressure side and the saturated pressure on the negative pressure side is detected, and the differential pressure between the detected differential pressure and the set differential pressure is detected. an electronic device that controls the stroke adjustment means according to the value, and controls the opening and closing of the gas supply valve means and the gas discharge valve means according to the detected saturation pressure on the negative pressure side or the positive pressure side and the set pressure value; A medical pump drive device comprising: control means;