JPH09220280A - Pressure transmission bulkhead device - Google Patents

Abstract

(57) 【Abstract】 PROBLEM TO BE SOLVED: To accurately detect the pressure of a flat portion which is momentarily stable among pressure fluctuations acting on a driven device such as a balloon catheter, and based on the pressure, the operating state of the driven device. To provide a pressure transmitting partition device that operates so that the pressure can be accurately grasped. SOLUTION: A first casing 42 and a second casing 4
The pressure generated in the first space 53 is arranged so as to partition the internal space formed by combining 4 with the first space 53 communicating with the input port 48 and the second space 55 communicating with the output port 50. The diaphragm 4 arranged so as to be reciprocally bendable between the first inner surface 49 and the second inner surface 51 due to fluctuations.
6 to form the escape passage grooves 52 and 54 for escaping the residual fluid existing on the contact surface between the diaphragm 46 and the first inner surface 49 or the second inner surface 51 to the input port 48 or the output port 50. is there.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an intra-aortic balloon pump (IAB) that alternately outputs positive pressure and negative pressure, for example.
P) or a pressure transmission bulkhead device used for the purpose of driving expansion / contraction of a medical device such as an artificial heart.

[0002]

2. Description of the Related Art For example, in a balloon catheter for IABP, the balloon is inserted into an arterial blood vessel in the vicinity of the heart of a patient and expanded and contracted in accordance with the pulsation of the heart, thereby performing an auxiliary treatment of the heart. As a drive device for inflating and deflating a balloon, for example, Japanese Patent Application Laid-Open No. 60-106464.
The drive device shown in the publication is known.

The drive device shown in this publication has a primary side piping system and a driving secondary side piping system, and these systems are connected to a pressure transmission partition device (generally, a capacity limiting device (VLD) or It is isolated by an isolator), the pressure fluctuation generated in the primary side piping system is transmitted to the secondary side piping system, and the balloon is inflated and deflated by the pressure change generated in the driving secondary side piping system. Helium gas is filled as shuttle gas in the secondary piping system for driving.

In this way, the pressure transmitting partition device is used to separate the primary piping system and the secondary piping system from the fluid for driving the balloon and the fluid as the source of the positive pressure and the negative pressure. This is because a different fluid is used and a gas having a small molecular weight is used when the balloon is inflated and deflated to improve the response during driving. Also, by keeping the secondary piping system airtight by eliminating leakage due to diffusion, a large amount of fluid in the relatively expensive secondary piping system is not consumed, that is, pressure is generated at low cost. This pressure transmission partition device makes the casing in which the internal space is formed of a hard one, and at the same time, the diaphragm mounted inside smoothly responds to the negative pressure and positive pressure from the primary side piping system. The structure is such that it will come into close contact with the inner wall and stop. With such a structure, the excluded volume of the secondary piping system is kept constant.
Therefore, by interposing this pressure transmitting partition device, it is possible to prevent the risk that a certain amount of gas or more leaks from the balloon into the body when the balloon is inflated and deflated in a state where the balloon membrane is damaged.

FIG. 16 shows a schematic sectional view of a pressure transmission partition device according to a conventional example. As shown in FIG. 16, the pressure transmission partition device 70 has a concave inner surface and a first casing 72 in which an input port 78 that can communicate with a primary side piping system (not shown) is formed, and a concave inner surface. And a second casing 74 having an output port 80 formed therein, which is capable of communicating with the secondary side piping system 18. The casings 72 and 74 are combined to form an internal space, and the internal space is partitioned by the diaphragm 76 into a first space communicating with the input port 78 and a second space communicating with the output port 80.

The secondary side piping system 18 communicates with, for example, an IABP balloon 22. When the positive pressure of the primary side driving fluid is introduced from the input port 78, the diaphragm 76 moves to the concave inner surface side of the second casing 74, the internal pressure of the secondary side piping system 18 and the balloon 22 increases, and the balloon 22 is Expands. Further, when the negative pressure of the primary side driving fluid is introduced from the input port 78, the diaphragm 76 moves to the first position.
It moves to the concave inner surface side of the casing 72 (state of FIG. 16), the internal pressure of the secondary side piping system 18 and the balloon 22 decreases, and the balloon 22 contracts. By positioning the balloon 22 in an arterial blood vessel near the heart and repeating the above-described expansion / contraction operations in synchronization with the heartbeat of the patient, the balloon 22 can assist blood pressure in IABP.

Pressure sensor 1 mounted on the secondary side piping system 18
5, when the pressure change in the balloon 22 is measured, a waveform as shown in FIG. 17 (A) is obtained. The peaks of the corrugations are the inflation phase of the balloon and the valleys of the corrugations are the systole of the balloon. FIG. 17B shows the timing of switching between inflation and deflation of the balloon.

As shown in FIG. 17 (A), in the process of inflation and deflation of the balloon, there are pressures P3 and P4 in regions where the pressures become flat and stable for a moment. The pressure P3 is a pressure before switching from deflation to inflation of the balloon, and the pressure P4 is a pressure before switching from inflation to deflation of the balloon.

[0009]

By detecting the values of the pressures P3 and P4 which are momentarily stable by the pressure sensor 15 shown in FIG. 16 and the like, the secondary side piping system 18 and the balloon 22 are sealed. Changes in the amount of secondary drive fluid (eg, helium gas) enclosed can be monitored.
For example, when the helium gas is enclosed, the helium gas having a small molecular weight is used as the balloon 22 or the piping system 18.
Since it escapes from the wall surface of the tube constituting the above by diffusion and permeation, it is necessary to replenish a certain amount of gas in the piping system 18 during use. Therefore, it is necessary to detect the value of the pressure P3 or P4 and judge whether or not the pressure is lower than the reference pressure.

Before switching from expansion to contraction, the pressure gradually approaches a constant pressure P4 shown in FIG. This asymptotic pressure value is called a plateau pressure. Since this pressure is a pressure in a state where the balloon is filled with the secondary driving fluid, the stable pressure (plateau pressure) P4 is detected for a moment to prevent the balloon from being damaged due to an unexpected situation such as bending. It has been proposed to detect that the volume has changed. For example, when the plateau pressure P4 is higher than usual, it can be inferred that the balloon is bent. Further, when the plateau pressure P4 becomes smaller than usual, it can be determined that the gas is leaking from the secondary piping system due to an unexpected situation other than permeation. Of course, in order to measure these plateau pressures P4, it is necessary that the period of inflation continues until the balloon is fully inflated. Unless you have a particularly high heart rate patient
This period is usually long enough. However, it is desirable to measure the pressure P4 with a margin, and immediately before the inflation to the deflation of the balloon.

However, in the conventional pressure transmitting partition device as shown in FIG. 16, a minute peak SP appears at the end of the pressure P4 as shown in FIG. When this minute peak SP appears, there is a problem that it becomes difficult to accurately detect the pressure P4. If the pressure P4 cannot be detected accurately, the volume of the balloon has changed due to an unexpected situation such as the balloon being bent,
It becomes difficult to detect abnormal leakage of driving gas.

Particularly, since the timing of inflation / deflation of the balloon is synchronized with the pulsation of the heart, when the inflation / deflation cycle of the balloon becomes short, the pressure P4 of the flat portion is not The probability that the pressure of the minute peak SP is erroneously detected becomes high, and it becomes difficult to accurately detect the abnormality.

The present invention has been made in view of such circumstances, and it is possible to accurately detect the pressure of a flat portion which is momentarily stable among pressure fluctuations acting on a driven device such as a balloon catheter, and based on the pressure, An object of the present invention is to provide a pressure transmission partition device that operates so that the operating state of a driven device can be accurately grasped.

[0014]

The inventors of the present invention have found that when a driven device is driven by using the pressure transmitting partition device, a minute peak generated in a flat portion of the pressure fluctuation is generated in a casing inner wall surface of the pressure transmitting partition device. It was found that the structure exists, and the present invention was completed. The present inventors have found that the cause of the minute peak is that when a flexible film body such as a diaphragm adheres to the inner wall surface of the pressure transmission partition wall device (a state immediately before switching the pressure), the film body and the wall surface adhere to each other. It was found that there was residual fluid on the surface. When such a residual fluid exists, it is considered that when the pressure is switched, the residual fluid flows into the first port or the second port, which causes a minute peak.

Therefore, in the pressure transmission partition device according to the present invention, the primary side piping system communicating with the pressure generating source generating the positive pressure and the negative pressure and the secondary side piping system communicating with the driven equipment are connected. Firstly, a pressure transmission partition device for transmitting a pressure fluctuation of the primary side piping system to the secondary side piping system, which has a first inner surface and is formed with a first port which is capable of communicating with the primary side piping system. A first casing, a second casing having a second inner surface and having a second port formed therein, the second port communicating with the secondary side piping system;
The internal space formed by combining the casing and the second casing is arranged so as to be partitioned into a first space that communicates with the first port and a second space that communicates with the second port. A flexible film body arranged so as to be reciprocally bendable between the first inner surface and the second inner surface due to pressure fluctuations generated in the space, and the flexible film body and the first inner surface or the second inner surface. The residual fluid existing on the contact surface with
It is characterized in that an escape passage is formed to escape to the port or the second port.

The escape passage may be a groove formed in at least one of the first inner surface and the second inner surface and extending in the radial direction around the first port or the second port. Further, the escape passage may be formed as a convex portion formed on at least one of the first inner surface and the second inner surface and extending in the radial direction around the first port or the second port.

The groove or the convex portion may extend continuously in the radial direction or may be formed intermittently. Further, the escape passage may be a hole formed in the side wall of the nozzle mounted on the first port or the second port and protruding toward the internal space.

Further, in the present invention, the escape passage may be formed on the surface of the flexible film body. When forming on the surface of the flexible film body, the escape passage is formed by forming a groove or a convex portion in the radial direction on the surface of the flexible film body. The groove or the convex portion may extend continuously in the radial direction or may be formed intermittently.

In the pressure transmitting partition device according to the present invention, the residual fluid existing on the contact surface between the flexible film body disposed in the casing of the device and the first inner surface or the second inner surface is removed by the first port or An escape passage is positively formed to escape to the second port. Therefore, immediately before the pressure is switched, the residual fluid existing on the contact surface between the flexible film body and the first inner surface or the second inner surface does not flow into the first port or the second port. Therefore, this does not cause a minute pressure fluctuation, and a minute peak does not occur in a stable and flat pressure region portion.

Therefore, according to the present invention, it is possible to accurately detect the pressure of the flat portion, which is stable for a moment among the pressure fluctuations acting on the driven device such as the balloon catheter, and based on the pressure, the operating state of the driven device. Can be accurately grasped.

[0021]

BEST MODE FOR CARRYING OUT THE INVENTION Hereinafter, a pressure transmission partition device according to the present invention will be described in detail based on an embodiment shown in the drawings. First Embodiment Before describing the pressure transmission partition device according to the present embodiment, the IABP balloon catheter 20 will be described first.

As shown in FIG. 5, the IABP balloon catheter 20 has a balloon 22 that expands and contracts according to the pulsation of the heart. The balloon 22 has a film thickness of about 1
It is composed of a tubular balloon film having a diameter of about 00 to 150 μm. In the present embodiment, the shape of the balloon membrane in the expanded state is a cylindrical shape, but it is not limited to this and may be a polygonal cylinder shape.

The IABP balloon 22 is made of a material having excellent bending fatigue resistance. The outer diameter and the length of the balloon 22 greatly affect the assisting effect of the heart function.
It is determined according to the inner volume of 2 and the inner diameter of the arterial blood vessel. The balloon 22 usually has an internal volume of 30 to 50c.
c, the outer diameter is 14 to 16 mm when expanded, and the length is 210 to 270 mm.

The distal end of the balloon 22 is attached to the outer periphery of the distal end of the inner tube 30 via a short tube 25 or directly by means such as heat fusion or adhesion. Balloon 2
The proximal end of 2 is joined to the distal end of the catheter tube 24, either directly or through a contrast marker such as a metal tube 27. A driving gas body is introduced into or drawn out from the balloon 22 through the first lumen formed inside the catheter tube 24, and the balloon 22 is expanded or contracted. The balloon 22 and the catheter tube 24 are joined by heat fusion or adhesion with an adhesive such as an ultraviolet curable resin.

The distal end of the inner tube 30 projects further than the distal end of the catheter tube 24. The inner tube 30 is a balloon 22
Also, the catheter tube 24 is inserted through the inside in the axial direction. The proximal end of the inner tube 30 communicates with the second port 32 of the branch portion 26. A second lumen that does not communicate with the first lumen formed inside the balloon 22 and inside the catheter tube 24 is formed inside the inner tube 30. The inner tube 30 is adapted to send the blood pressure taken at the open end 23 at the distal end to the second port 32 of the bifurcation 26, and measure the blood pressure fluctuation from there.

When inserting the balloon catheter 20 into an artery, the second lumen of the inner tube 30 located in the balloon 22 is also used as a guide wire insertion lumen for inserting the balloon 22 into the artery conveniently. When inserting the balloon catheter into a body cavity such as a blood vessel, the balloon 22 is folded and wound around the outer circumference of the inner tube 30. The inner tube 30 shown in FIG. 5 is made of a material similar to that of the catheter tube 24, for example. The inner diameter of the inner tube 30 is not particularly limited as long as it can be inserted through the guide wire, and is, for example, 0.
It is 15 to 1.5 mm, preferably 0.5 to 1 mm. The wall thickness of the inner tube 30 is preferably 0.1 to 0.4 mm. The total length of the inner tube 30 is determined according to the axial length of the balloon catheter 20 inserted into the blood vessel, and is not particularly limited, but is, for example, 500 to 1200 mm, preferably 70.
It is about 0 to 1000 mm.

The catheter tube 24 is preferably made of a material having some flexibility. The inner diameter of the catheter tube 24 is preferably 1.5 to 4.0 mm, and the wall thickness of the catheter tube 24 is preferably 0.05 to 0.4.
mm. The length of the catheter tube 24 is preferably 30
It is about 0 to 800 mm.

A branch portion 26, which is placed outside the patient's body, is connected to the proximal end of the catheter tube 24. The branch portion 26 is formed separately from the catheter tube 24 and fixed by means of heat fusion or adhesion. The first lumen port 2 for introducing or discharging the pressure fluid into the first lumen in the catheter tube 24 and the balloon 22 at the branch portion 26.
8 and a second lumen port 32 communicating with the second lumen of the inner pipe 30 are formed.

The first lumen port 28 is connected to, for example, the drive unit 9 shown in FIG. 6, and the drive unit 9 introduces or leads the fluid pressure into the balloon 22. Although the fluid to be introduced is not particularly limited, helium gas or the like having a small mass is used so that the balloon 22 quickly expands or contracts in response to the driving of the driving device 9.

Details of the drive unit 9 will be described later with reference to FIG. The second lumen port 32 is connected to the blood pressure fluctuation measuring device 29 shown in FIG. 6, and can measure the fluctuation of blood pressure in the artery taken from the open end 23 at the distal end of the balloon 22. Based on the change in blood pressure measured by the blood pressure measuring device 29, the pump device 9 is controlled according to the pulsation of the heart 1 shown in FIG. 6, and the balloon 22 is expanded and contracted in a short cycle of 0.4 to 1 second. It is like this.

In the IABP balloon catheter 20,
As described above, helium gas or the like having a small mass is used as the fluid to be introduced into and discharged from the balloon 22 in consideration of responsiveness and the like. If the positive pressure and the negative pressure of the helium gas are directly produced by a pump or a compressor, the gas consumption is large and the economy is difficult, and it is difficult to control the capacity. Therefore, the structure shown in FIG. 3 is used. Has been adopted. That is, the secondary piping system 18 communicating with the inside of the balloon 22 and the primary piping system 17 communicating with the pumps 4a and 4b as pressure generating means are separated by the pressure transmission partition device 40 according to the present embodiment.

In this embodiment, as shown in FIG. 1 (A), the pressure transmission partition device 40 includes a primary side piping system 17 (see FIG. 3).
Input port 48 as the first port that can communicate with
And the first casing 42 in which the secondary side piping system 18 is formed.
(See FIG. 3) and a second casing 44 in which an output port 50 as a second port capable of communicating with the second casing 44 is formed. The first casing 42 is formed with a conical concave first inner surface 49, and the second casing 44 is formed with a conical concave second inner surface 51. The casings 42 and 44 are made of a material such as metal that is not easily deformed.

The casings 42 and 44 are assembled with, for example, bolts to form an internal space. A diaphragm 46 serving as a flexible film body is arranged between the casings 42 and 44, and an internal space formed by the casings 42 and 44 is connected to the first space 53 communicating with the input port 48 by the diaphragm 46. , And a second space 55 communicating with the output port 50. Note that FIG. 1A shows a state in which the casings 42 and 44 and the diaphragm 46 are disassembled.

The diaphragm 46 is shown in FIGS.
As shown in FIG. 2, it is a disk-shaped elastic film body, and is made of, for example, styrene-butadiene rubber (SBR), butadiene rubber (BR), isoprene rubber (IR), nitrile butadiene rubber (NBR), chloroprene rubber (CR), or the like. Diene rubber, butyl rubber (IIR), ethylene-propylene-diene terpolymer rubber (EPDM), acrylic rubber, olefin rubber such as chlorosulfonated polyethylene rubber, fluorine rubber, silicone rubber, urethane rubber, polysulfide rubber, etc. To be done. This diaphragm 4
The surface of 6 is preferably embossed.

At the center of the diaphragm 46, as shown in FIG.
As shown in (B), it is preferable that the thick portion 41 is formed. The diameter of the thick portion 41 is preferably slightly larger than the inner diameters of the input port 48 and the output port 50 shown in FIG. The thickness of the diaphragm 46 other than the thick portion 41 is not particularly limited, but is 0.5
It is preferably about 1.5 mm. The thickness of the thick portion 41 is not particularly limited, but is preferably about 1 to 2 mm.

Bolt holes 45 are formed on the outer periphery of the diaphragm 46. Bolts for assembling the casings 42 and 44 shown in FIG. 1A are passed through these bolt holes 45. As shown in FIG. 2C, a sealing projection 47 having a substantially semicircular cross section is formed on the inner peripheral side of these bolt holes 45. The sealing protrusion 47 is shown in FIG.
The casing 42 and 44 shown in FIG. As shown in FIG. 1A, the diaphragm 46 is attached to the casings 42, 44.
By interposing it between them, the inner space of the casing is partitioned into the first space 53 and the second space 55, and is in a state of not communicating with each other.

However, although the fluid communication is cut off,
The pressure change (volume change) in the first space 53 is transmitted as the pressure change (volume change) in the second space 55 due to the displacement of the diaphragm 46. By adopting such a structure, the primary piping system 17 and the secondary piping system 18 shown in FIG.
Can be transmitted to the secondary piping system 18.
Further, it is easy to control the volume (chemical equivalent) of the gas sealed in the secondary piping system 18 to be constant.

In the present embodiment, as shown in FIGS. 1A to 1C, the first inner surface 49 and the second inner surface 51 of both casings 42 and 44 are radially (radius) centered around the ports 48 and 50. Grooves 52, 54 (extending in the direction) are formed.
In the present embodiment, these grooves 52, 54 are the ports 48,
Eight of each is formed around 50. The cross-sectional shape of these grooves 52, 54 is not particularly limited, and may be, for example, an inverted triangular shape as shown in FIG.
It may have a semicircular shape.

The width of these grooves 52 and 54 is not particularly limited, but is preferably 0.2 to 10 mm, and the depth of the grooves 52 and 54 is preferably 0.3 to 5 mm. These grooves 52 and 54 become the escape passages in the present invention. The upper and lower limits of the width of these grooves 52 and 54 are determined so as to be effective as a relief passage, and the lower limits of the depth of the grooves 52 and 54 are also determined so as to be effective as a relief passage. The upper limits of the depths of the grooves 52 and 54 are determined within a reasonable range in consideration of the thickness of the casing.

The pressure transmitting partition device 40 according to this embodiment having the above-mentioned structure is used as a part of the driving device 9 shown in FIG. In the present embodiment, the pressure transmission partition device 4
0 is used as the internal fluid of the primary piping system 17 connected to the input port 48 (see FIG. 1A), and the output port 50
The internal fluid of the secondary piping system 18 connected to (see FIG. 1A) is helium gas. The reason why the internal fluid of the secondary piping system 18 is helium gas is that a gas with a small mass is used to enhance the response of the balloon 22 to the expansion and contraction.

As shown in FIG. 3, the primary piping system 17 includes
Two pumps 4a and 4b are arranged as pressure generating means. One of the first pumps 4a is a positive pressure generating pump (also referred to as a compressor; the same applies hereinafter), and the other second pump 4b is a negative pressure generating pump. A first pressure tank 2 as a positive pressure tank is connected to a positive pressure output port of the first pump 4a via a pressure reducing valve 7. Also, the second
A second pressure tank 3 as a negative pressure tank is connected to a negative pressure output port of the pump 4b via a throttle valve 8.

First pressure tank 2 and second pressure tank 3
Pressure sensors 5 and 6 as pressure detecting means for detecting the respective internal pressures are mounted on the. The pressure tanks 2 and 3 are connected to the input ends of the first solenoid valve 11 and the second solenoid valve 12, respectively. These solenoid valves 11, 12
The opening and closing of is controlled by a control means (not shown),
For example, it is controlled in response to the pulsation of the patient's heart. The output ends of these solenoid valves 11 and 12 are connected to the input port 48 of the pressure transmission partition device 40 shown in FIG.

The output port 50 of the pressure transmission partition device 40 shown in FIG. 1 is connected to the secondary piping system 18 shown in FIG. The secondary piping system 18 communicates with the inside of the balloon 22 and is a closed system in which helium gas is sealed. The secondary piping system 18 is composed of a hose or a tube. A pressure sensor 15 as a pressure detecting means for detecting the internal pressure of the secondary piping system 18 is attached to the secondary piping system 18. The output of the pressure sensor 15 is input to the control means.

An exhaust pump is connected to the secondary piping system 18 via a solenoid valve (not shown). The solenoid valve and the exhaust pump are used to evacuate the inside of the piping system 18 in order to replace the inside of the secondary piping system 18 with helium gas before use. Is closed and the pump does not run.

Further, in this secondary piping system 18, a replenishing device 6 for replenishing a predetermined amount of helium gas so that the chemical equivalent of the gas is always kept constant inside the secondary piping system 18.
0 is connected. The replenishing device 60 has a primary helium gas tank 61. The helium gas tank 61 is provided with a secondary helium gas tank 64 via pressure reducing valves 62 and 63.
Is connected. A pressure sensor 65 is attached to the secondary helium gas tank 64, which detects the pressure in the tank 64 and controls so that the pressure in the tank 64 is kept constant. For example, the pressure in the tank 64 is 100 mmHg
It is controlled to the following level.

The secondary helium tank 64 has a throttle valve 67.
A replenishment solenoid valve 66 is connected through the replenishment solenoid valve, and an initial filling solenoid valve 68 is connected in parallel with the replenishment solenoid valve 66. These solenoid valves 66 and 68 are controlled by the control means. The electromagnetic valve 68 for initial filling opens in conjunction with the pump for vacuuming and is used when initially filling the negative pressure in the secondary piping system 18 with helium gas. In the normal use state, the solenoid valve 68 does not operate. In addition, the replenishment solenoid valve 66 is used for the secondary piping system 1 while the balloon 22 is in use.
8 is a solenoid valve for replenishing gas. Since the helium gas permeates through the balloon 22 and the piping system 18 by diffusion, the solenoid valve 18 is provided in order to control the volume (chemical equivalent) of the gas in the balloon 22 to be constant.

Next, an operation example of the medical device driving apparatus according to this embodiment will be described. In this embodiment, the pressure PT1 in the first pressure tank 2 is set to about 300 mmHg (gauge pressure) by driving the pump 4a, and the pressure PT2 in the second pressure tank 3 is driven by driving the pump 4b. Is set to about -150 mmHg (gauge pressure). Then, the pressure applied to the input end of the pressure transmission partition device 40 shown in FIG. 1 is switched to the pressure of the first pressure tank 2 and the second pressure tank 3 by alternately driving the solenoid valves 11 and 12. The timing of this switching is controlled by the control means so as to be synchronized with the heartbeat of the patient.

When positive pressure is introduced from the input port 48 shown in FIG. 1, the diaphragm 46 moves to the concave inner surface 51 side of the second casing 44, and the inside of the secondary side piping system 18 and the balloon 22 shown in FIG. The pressure increases and balloon 22 expands. Further, when negative pressure is introduced from the input port 48, the diaphragm 46 moves to the concave inner surface 49 side of the first casing 42, and the internal pressures of the secondary side piping system 18 and the balloon 22 shown in FIG. 3 decrease, The balloon 22 is deflated.

FIG. 4A shows pressure fluctuations detected by the pressure sensors 5 and 6 shown in FIG. In addition, the solenoid valve 11,
As a result of the pressure switching drive by 12, the pressure fluctuation in the secondary piping system 18 shown in FIG. 3 is detected by the pressure sensor 15, and the result is shown in FIG. The maximum value of the pressure fluctuation in the secondary piping system 18 is, for example, 289 mmHg (cage pressure),
The minimum value is -114 mmHg (gauge pressure). As a result of the pressure fluctuation shown in FIG. 4 (B) in the secondary piping system 18,
In the balloon 22, a volume change occurs as shown in FIG. 4C, the balloon 22 can be inflated and deflated according to the beating of the heart, and an auxiliary treatment of the heart can be performed.

In this embodiment, the pressure detected by the pressure sensor 15 shown in FIG. 3 is detected at the timing of switching the deflated state of the balloon in FIGS. 17A and 17B to the inflated state (including immediately before that). The detected pressure P3 (Fig. 1
7 (A)), the solenoid valve 66 shown in FIG. 3 is opened so that the secondary pipe system 18 is supplemented with gas so that the predetermined value is obtained. The opening control of the solenoid valve 66 is not particularly limited, but is, for example, 8 m.
The control is to open the valve 66 at a timing of sec × n times. The number of times n is, for example, 2 to 10 times. Detection pressure P3
In the present embodiment, the predetermined value of is a value that varies depending on the volume of the balloon 22, and is + 10 ± 4 mmHg (gauge pressure) for a volume of 40 cc and −30 ± 4 mmHg for a volume of 30 cc. (Gauge pressure). When the detected pressure P3 falls below these values, the control means drives the solenoid valve 68 shown in FIG. 3 to supplement the helium gas from the secondary helium gas tank 64 to the inside of the secondary piping system 18. The detected pressure P3 shown in (A) is controlled to be a predetermined value.

In the present embodiment, with the balloon 22 in a deflated state, a fixed volume (constant number of moles: chemical equivalent ratio) of gas is introduced into the closed piping system 18 connected to the balloon 22.
After that, the reduction of the gas, which is reduced by the permeation from the balloon 22 or the like, is always monitored with the balloon 22 deflated.

Therefore, in this embodiment, the influence on the gas pressure of the balloon 22 which can be deformed by an external force is eliminated, and the gas corresponding to the capacity of the arbitrary drive piping system 18 (including the tube and the hose) and the balloon is removed. It is possible to keep the chemical equivalent constant. If controlled in this way, the balloon 22 can be obtained by observing the plateau pressure P4 (the pressure when the balloon is inflated) shown in FIG.
It is possible to detect that the volume of the balloon 22 has changed due to an unforeseen situation such as a bent portion. For example, when the plateau pressure P4 is higher than usual, it can be determined that the balloon 22 is bent. Further, when the plateau pressure P4 becomes lower than usual, it can be determined that the gas is leaking due to an unexpected situation other than permeation.

Particularly in this embodiment, as shown in FIG.
Since the grooves 52 and 54 extending in the radial direction around the ports 48 and 50 are formed in the concave inner surfaces 49 and 51 of the casings 42 and 44 that form the pressure transmission partition device, the diaphragm 46 and the inner surfaces immediately before the pressure switching. The residual fluid existing on the contact surface with 49 and 51 does not flow into the first port 48 or the second port 50. Therefore, this does not cause a minute pressure fluctuation, and a minute peak SP does not occur in a stable and flat pressure area portion (pressure P4 portion shown in FIG. 17A).

Therefore, in the present embodiment, it is possible to accurately detect the pressure P4 or P3 (see FIG. 17) of the flat portion which is momentarily stable among the pressure fluctuations acting on the balloon 22 shown in FIG. Based on this, the operating state of the balloon 22 can be accurately grasped.

From the viewpoint of eliminating only the minute peak SP generated in the plateau pressure P4 shown in FIG. 17, the contact surface between the diaphragm 46 and the second inner surface 51 shown in FIG. It is only necessary to prevent the residual fluid existing in the above from flowing into the second port 50. From that point of view, the second inner surface 5 of the second casing 44
Although it is sufficient to form the groove 54 only in No. 1, in the present embodiment,
Grooves 52 and 54 are formed in both casings 42 and 44. Therefore, not only the small peak SP in the pressure P4 region shown in FIG. 17 but also the small peak (not shown) in the pressure P3 region can be reduced.

Second Embodiment In this embodiment, as shown in FIGS. 7A and 7B, only the second inner surface 51 of one of the second casings 44 of the pressure transmission partition device serves as the second port. Two radial grooves 54 are formed at 180-degree symmetrical positions with respect to the output port 50. The depth and width of the groove 54 are the same as those in the first embodiment. As the first casing combined with the second casing 44 via the diaphragm, one having no groove on the first inner surface is used.

The other structure is the same as that of the first embodiment, and its explanation and illustration are omitted. In the pressure transmission partition device of the present embodiment, the number of the grooves 54 is as small as two as compared with the pressure transmission partition device of the first embodiment shown in FIG. 1, but the small peak SP shown in FIG. 17 (A) is reduced. It was confirmed by the examples described later that the effect of 1 was the same as that of the above-mentioned embodiment.

Third Embodiment In this embodiment, as shown in FIGS. 8A and 8B, only the second inner surface 51a of the second casing 44a of the pressure transmission partition device serves as the second port. Output port 50a
Two radial convex portions 54a are formed at 180-degree symmetrical positions with respect to the center. By forming the convex portion 54a on the second inner surface, the diaphragm and the second inner surface 51, which are omitted in the drawing, are saved.
When it comes into close contact with a, an escape passage communicating with the output port 50a is formed between the close contact surfaces. From this point of view, the convex portion 5
4a does not necessarily have to be formed continuously in the radial direction, but may be formed intermittently.

The projection height of the convex portion 54a is not particularly limited, but if it is too low, there is no effect, and if it is too high, the movement of the diaphragm is restricted, so it is about 0.15 to 3 mm, preferably about 0.3 to 2 mm. Is preferred. The width of the convex portion 54a is not particularly limited, but is preferably about 0.2 to 10 mm. The number of protrusions 54a formed is not particularly limited, but is preferably two or more.

As the first casing combined with the second casing 44a via the diaphragm, one having no convex portion or groove on the first inner surface may be used, or a convex portion similar to that shown in FIG. The portion 54a or a groove 54 similar to that shown in FIG. 7 may be used.

The other structure is the same as that of the first embodiment, and its explanation and illustration are omitted. The pressure transmitting partition device of the present embodiment is different from the pressure transmitting partition device of the first embodiment shown in FIG.
Although a is formed, the minute peak S shown in FIG.
It has been confirmed by the examples described later that the effect of reducing P was similar to that of the above-described embodiment.

Fourth Embodiment As shown in FIGS. 9A and 9B, a pressure transmission partition device 40b according to the present embodiment has a first casing 42b having a concave first inner surface 49b and a concave shape. Second inner surface 51b of
It is similar to the first embodiment shown in FIG. 1 in that it has a second casing 44b formed with. Further, the diaphragm 46 is mounted between the casings 42b and 44b, and the casing inner space is defined by the first space 53b and the second space 5b.
The same applies in that it is airtightly divided into 5b. Due to the pressure introduced into the first space 53b, the diaphragm 46 moves to the first
The position where the inner surface 49b is in close contact with the second inner surface 51
Even at the point where it flexes and moves to the position where it tries to come into close contact with the b side,
It is similar to the device of the embodiment shown in FIG.

The present embodiment differs from the first to third embodiments in that the inner surface 49b, 51b is not provided with a groove or a convex portion and the input port 4 as the first port is used.
8b and the output port 50b as the second port are equipped with the nozzle 56 shown in FIG. 9 (B), respectively. The nozzle 56 of this embodiment has a through hole 57 extending in the axial direction. On the outer peripheral side wall of the tip of the nozzle 56,
A relief hole 58 is formed. The escape hole 58 communicates with the through hole 57.

The nozzle 56 has a tip (hole 5) for the input port 48b and the output port 50b.
8 is formed so as to protrude from the inner surfaces 49b and 51b by a step t. Protruding step t
Is not particularly limited, but is preferably about 0.5 to 5 mm, and is set so that the escape hole 58 communicates with the respective spaces 53b and 55b.

In the device 40b according to the present embodiment, the residual fluid existing between the diaphragm 46 and the inner surface 49b, 51b starts to come into close contact with either of the inner surfaces 49b, 51b through the through hole 57 through the relief hole 58 and the primary fluid. Conveniently discharged to the piping system or secondary piping system. Therefore, the pressure is switched and the diaphragm 46 is attached to one of the inner surfaces 49b,
When it is moved in the direction away from 51b, the extra residual fluid does not cause the minute peak SP shown in FIG. 17 (A).

The plateau pressure P shown in FIG.
From the viewpoint of eliminating only the minute peaks in the four regions, the nozzle 56 may be attached only to the output port 50b (the side connected to the balloon) shown in FIG. Therefore, by using the device 40b of the present embodiment, as in the device 40 shown in FIG. 1, it is possible to accurately detect the pressure P4 of the flat portion of the pressure fluctuation acting on the balloon 22, which is stable for a moment, and the pressure P4 is detected. Based on this, the operating state of the balloon can be accurately grasped.

Fifth Embodiment As shown in FIG. 10, a pressure transmission partition device 40c according to the present embodiment is different only in the shape of casings 42c and 44c having respective ports 48c and 50c, and other than that, This is the same as the device according to any one of the first to fourth embodiments.

In the apparatus of this embodiment, each casing 42
The concave shapes of the inner surfaces 49c and 51c of c and 44c have a boat-shaped cross section. As the shape of the casing, other than these shapes, various shapes can be adopted as long as they have a shape in which a space is generated inside and a diaphragm is interposed therebetween. However, FIG.
A casing having a conical concave inner surface as shown in (3) is preferable from the viewpoint of good responsiveness of reciprocal movement of the diaphragm and improvement of responsiveness of expansion / contraction of the balloon.

The shape of the diaphragm as the flexible film is not limited to that of the above embodiment, and as shown in FIG. 11, it may be continuously or intermittently provided in the vicinity of the outer circumference of the diaphragm 46a along the circumferential direction. The corrugated portion 43 may be formed. By forming the corrugated portion 43, the durability of the diaphragm 46a is improved.

The present invention is not limited to the above-mentioned embodiment, but can be variously modified within the scope of the present invention. For example, in the above-described embodiment, as the pressure generating means, as shown in FIG.
In the present invention, a single pump is used, the positive pressure output end is connected to the first pressure tank 2 as a positive pressure tank, and the negative pressure output end of the pump is negative pressure. You may connect the 2nd pressure tank 3 as a tank. In that case, the number of pumps can be reduced, which contributes to weight reduction and energy saving of the device.

Further, in the above embodiment, as the pressure switching means, as shown in FIG. 3, two solenoid valves, the third solenoid valve 11 and the fourth solenoid valve 12, were used, but the present invention is not limited to this. Without limitation, a single three-way valve may be used to
The pressure applied to the input port may be switched.

Further, the gas species of the primary piping system 17 shown in FIG. 3 is not limited to air, but may be other fluids.
Further, the gas type of the secondary piping system 18 is not limited to the helium gas, and other fluid may be used. Further, in the above-described embodiment, the balloon catheter was used as the driven device, but the drive device using the pressure transmission partition device according to the present invention is a medical device driven by positive pressure and negative pressure, It can also be used for driving other medical devices. As the other medical device, for example, an artificial heart can be exemplified. Further, the drive device using the pressure transmission partition device according to the present invention can be applied not only to medical devices but also to applications in which it is necessary to drive while monitoring the pressure change of driven devices. You can

[0073]

EXAMPLES The present invention will be described below based on more specific examples, but the present invention is not limited to these examples. Example 1 In the casing 44 shown in FIG. 7, the width is 1 mm and the depth is 1 mm.
Groove 54 on the inner surface 51 of the casing 44 to the port 50.
Was formed at a 180-degree symmetrical position with respect to the center. The length of the groove 54 was 85 mm. Outer diameter of casing 44 is 120 mm
Met. The thickness of the casing 44 was 16 mm.
Two such casings 44 were prepared. The volume of the casing internal space formed by combining these casings 44 was about 56 cc. As the diaphragm, the diaphragm 46 shown in FIGS. 2A to 2C was used. The outer diameter of the diaphragm 46 was 115 mm. The thick portion 41 of this diaphragm had a thickness of 1.0 mm, and the other portions had a thickness of 0.6 mm. Further, the protrusion height of each of the sealing protrusions 47 was 0.25 mm (0.5 mm on both sides).

A pressure transmission partition device was assembled by combining the two casings shown in FIG. 7 and the diaphragm shown in FIG. This device is incorporated into the driving device 9 shown in FIG. 3, and the balloon 22 is expanded at a rate of 120 beats per minute.
When contraction driving was performed and pressure fluctuations were observed by the pressure sensor 15 shown in FIG. 3, as shown in FIG. 12, no minute peak (notch) was observed at the end of the plateau pressure P4.

Comparative Example 1 Two casings similar to the casing 44 used in Example 1 except that the groove 54 was not formed, and the diaphragm used in Example 1 were prepared and assembled. A pressure transfer bulkhead device was formed.

The device according to this comparative example was incorporated into the driving device 9 shown in FIG.
Was driven and the pressure change was observed, and the results shown in FIG. 13 were obtained. As compared with Example 1, a minute peak SP (notch) appears in the plateau pressure P4.

Comparative Example 2 The same two casings as in Comparative Example 1 except that the concave inner surface of the casing was roughened using silica sand having a diameter of about 80 μm, and the diaphragm used in Example 1 were assembled and pressure was applied. A transfer bulkhead device was formed.

The device according to this comparative example was incorporated into the driving device 9 shown in FIG.
Was driven and the pressure change was observed, and the results shown in FIG. 13 were obtained. The minute peak SP (notch) existing at the plateau pressure P4 was not eliminated.

Example 2 Two casings similar to the casing 44 used in Example 1 except that the groove 54 was not formed at all, a diaphragm used in Example 1 and a diaphragm shown in FIG. 9B. Two nozzles 56 were prepared and assembled to form a pressure transmission partition device. As shown in FIG. 9A, the nozzle 56 was attached to each of the ports 48b and 50b so that the protruding step t was 2 mm.

The device according to the second embodiment is incorporated into the driving device 9 shown in FIG. 3, and the balloon 2 is manufactured in the same manner as in the first embodiment.
When No. 2 was driven and the pressure change was observed, the same results as in Example 1 were obtained as shown in FIG. Example 3 As shown in FIGS. 8A and 8B, instead of the groove, the width is 0.3 mm, the protruding height is 0.3 mm, and the radial length is about 35 mm.
The pressure transmission is performed by using two casings similar to those in the first embodiment except that two convex portions 54a are formed at 180-degree symmetrical positions with respect to the port 50a and the diaphragm used in the first embodiment. The septum device was assembled.

The device according to the third embodiment is incorporated into the driving device 9 shown in FIG. 3, and the balloon 2 is processed in the same manner as in the first embodiment.
When No. 2 was driven and the pressure change was observed, the same results as in Example 1 were obtained as shown in FIG. Example 4 The protrusion height of the convex portion 54a shown in FIGS.
Using two casings similar to those in Example 3 and the diaphragm used in Example 1 except that the diameter was 0.15 mm,
A pressure transfer bulkhead device was assembled.

The device according to the fourth embodiment is incorporated into the driving device 9 shown in FIG. 3, and the balloon 2 is processed in the same manner as in the first embodiment.
When No. 2 was driven and the pressure change was observed, as shown in FIG. 15, a decrease in the peak height of the minute peak SP was observed as compared with the comparative example. Example 5 In the radial direction on both front and back surfaces of the flexible film body shown in FIG.
A linear protrusion having a length of 5 mm, a height of 0.5 mm and a length of 60 mm was provided.

A pressure transmitting partition device was assembled by combining this membrane with two casings similar to the casing 44 used in Comparative Example 1 in which no groove was formed at all. The device according to Example 5 was incorporated into the driving device 9 shown in FIG. 3, the balloon 22 was driven in the same manner as in Example 1, and the change in pressure was observed. The same results as in Example 1 were obtained.

[0084]

As described above, when a driven device such as a balloon catheter is driven by using the pressure transmitting partition device according to the present invention, the flat portion which is momentarily stable among the pressure fluctuations acting on the driven device. Can be accurately detected, and the operating state of the driven device can be accurately grasped based on the pressure.

[Brief description of drawings]

1A is an exploded side view of a pressure transmission partition device according to an embodiment of the present invention, FIG. 1B is a front view of an inner surface of a casing, and FIG. 1C is a main part of a groove. FIG.

2A is a front view of a diaphragm, FIG. 2B is a cross-sectional view of an essential part of a central portion of the diaphragm, and FIG. 2C is a cross-sectional view of an essential part of an end portion of the diaphragm.

FIG. 3 is a schematic configuration diagram of a balloon driving device.

4A is a graph showing a change in internal pressure of each pressure tank, FIG. 4B is a graph showing a pressure change on the balloon side, and FIG. 4C is a graph showing a change in volume of the balloon. .

FIG. 5 is a schematic sectional view showing an example of a balloon catheter.

FIG. 6 is a schematic view showing an example of use of a balloon catheter.

FIG. 7A is a sectional view of a casing used in a pressure transmission partition device according to another embodiment of the present invention, and FIG. 7B is a front view of the inner surface side of the casing.

FIG. 8 (A) is a sectional view of a casing used in a pressure transmission partition device according to another embodiment of the present invention, and FIG. 8 (B) is an inner surface side front view of the casing.

9A is a sectional view of a pressure transmission partition device according to another embodiment of the present invention, and FIG. 9B is a perspective view of a nozzle used in the device.

FIG. 10 is a sectional view of a casing used in another embodiment of the present invention.

FIG. 11 is a sectional view of a diaphragm used in another embodiment of the present invention.

FIG. 12 is a graph showing pressure fluctuation when the pressure transmission partition device according to the embodiment of the present invention is used.

FIG. 13 is a graph showing pressure fluctuations when a pressure transmission partition device according to a comparative example is used.

FIG. 14 is a graph showing pressure fluctuation when a pressure transmission partition device according to another embodiment of the present invention is used.

FIG. 15 is a graph showing pressure fluctuations when a pressure transmission partition device according to still another embodiment of the present invention is used.

FIG. 16 is a schematic sectional view of a pressure transmission partition device according to a conventional example.

FIG. 17 is a graph showing the relationship between the change in pressure inside the balloon and the timing of switching between inflation and deflation.

[Explanation of symbols]

 2 ... 1st pressure tank 3 ... 2nd pressure tank 4a, 4b ... Pump 5, 6, 15, 15 ... Pressure sensor 11, 12, 16, 19, 19, 66, 68 ... Solenoid valve 17 ... Primary piping system 18 ... Secondary piping System (driving pipe system) 20 ... Balloon catheter 22 ... Balloon 40 ... Pressure transmission partition device 42 ... First casing 44 ... Second casing 46 ... Diaphragm 48 ... Input port (first port) 49 ... First inner surface 50 ... Output Port (second port) 51 ... Second inner surface 52 ... Groove 53 ... First space 54 ... Groove 54a ... Convex portion 55 ... Second space 56 ... Nozzle 58 ... Escape hole

Claims (1)

[Claims] 1. A pressure fluctuation in the primary side piping system without connecting the primary side piping system communicating with the pressure generating source generating positive pressure and negative pressure with the secondary side piping system communicating with the driven equipment. Is a pressure transmission bulkhead device for transmitting to the secondary side piping system, having a first inner surface and having a first casing formed with a first port capable of communicating with the primary side piping system, and having a second inner surface. A second casing in which a second port that is capable of communicating with the secondary side piping system is formed; and an internal space formed by combining the first casing and the second casing, that communicates with the first port It is arranged so as to partition into one space and a second space that communicates with the second port, and is arranged so as to be capable of reciprocating bending between the first inner surface and the second inner surface due to pressure fluctuations occurring in the first space. A flexible film body, and the flexible film body and the first inner surface or Pressure transmitting bulkhead apparatus passage is formed relief for releasing residual fluid present in the contact surface to the first port or the second port of the inner surface.