JPH07265411A - Auxiliary circulating device for blood - Google Patents

Abstract

PURPOSE:To make combination use of an IABP method and PCPS method and to maintain advantages of both. CONSTITUTION:This auxiliary circulating device 40 for blood has a balloon catheter 1 for intra-aorta use, a blood removing catheter 11, a blood feed catheter 12 to be inserted so as to exist on the downstream side of the balloon catheter 1, a blood feed means 71 for feeding the blood from the catheter 11 side to the catheter 12 side and a controller 50. The balloon catheter 1 has a balloon 3 for pumping and first and second balloons 4, 5 for blocking flood flow. The controller 50 has a function to select a mode combination use of IABP and PCPS, IABP mode and PCPS mode and enables alternate operation of the two balloons for blocking blood flow in the combination mode and pumping by the balloons for blocking blood flow in the IABP mode.

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 catheter and a blood assisted circulation device which are inserted into the aorta of a human body and used to assist the work of the heart.

[0002]

2. Description of the Related Art Conventionally, blood assisted circulation methods include a method using an arteriovenous bypass, a method using an auxiliary artificial heart, and an intra-aortic balloon pumping method (IABP method). The method using the assisting artificial heart has the highest blood flow assisting effect, but it requires a thoracotomy, which imposes a heavy burden on the patient and is complicated in operation. Also IABP
The method is easy to operate, but the main effect is to assist blood pressure by inflating and deflating a balloon inserted in the aorta,
The amount of blood flow that could be increased was small, and the effect of assisted circulation was low.

A PC is used as an arteriovenous bypass method.
Percutaneous cardiopulmonary bypass called the PS method has been performed. Although the PCPS method has a lower assisted circulation effect than the assisted artificial heart, it does not require a thoracotomy, imposes less burden on the patient, and has a higher assisted circulation effect than the IABP method. In the blood assisting circulation device used for the PCPS method, a blood removal side blood tube having a blood removal side catheter attached to the distal end, which is inserted from the femoral vein and left indwelling in the right atrium, a blood pump, an artificial lung, and a blood supply side. At least a blood tube is provided. Further, as the blood pump, a constant pressure pump (for example, a centrifugal pump) or a roller pump is used. Further, it has been considered to use the IABP method and the arteriovenous bypass method in combination by performing blood assist circulation with higher efficiency.

[0004]

According to the IABP method,
By inflating and deflating the balloon in synchronization with the heartbeat, it has the effects of reducing the afterload (resistance at the time of blood pumping), increasing the aortic pressure, and increasing the coronary blood flow.
Further, according to the bypass method such as the PCPS method, there is an effect of reducing the preload (blood pressure returning to the heart) and maintaining (increasing) the extracorporeal blood flow. However, there are some problems such as increased afterload and difficult management. Conversely, IABP
According to the method, as described above, the amount of blood circulation that can be increased is not large, and there is no effect of reducing the preload. Therefore, the present inventor examined the combined use of the IABP method and the PCPS method. Although it was thought that a synergistic effect or a synergistic effect could be obtained by using both of them together, conversely, there was a problem from the following points. The problem seems to be related to non-physiological hemodynamics when both are used together.

Generally, in the PCPS method, blood is fed retrogradely through the femoral artery. That is, it collides with the blood flow emitted from the failing heart near the thoracic abdominal aorta. Therefore, the PC
If the arteriovenous bypass volume by the PS method is large, the blood flow in the thoracic aorta may reverse when the IABP balloon is deflated, and the IABP method reduces the contractile load (sy
stolic unloading effect and afterload reduction effect) decrease. Further, when the balloon is inflated, the resistance to blood feeding by the PCPS method increases, so the blood feeding amount decreases. At the same time, preload on the failing heart will also increase, resulting in increased myocardial oxygen consumption. Therefore, the systemic blood circulation is maintained, the failing heart is rested, and the cardiac function is not restored. From the viewpoint of cardioprotection, the condition is not always good, but rather the IABP method. PC
There is a high possibility that the advantages of the PS method will be canceled out.

The assisted circulation performed by the combined use of the IABP method and the PCPS method ends when the patient recovers. However, the recovery of the patient is not a gradual one and the recovery is often gradual, and when both of them are finished at the same time, the cardiac function may be deteriorated again and the auxiliary circulation may be required again. Further, the amount of assisted circulation may be insufficient in the case of blood assisted circulation using only the pumping balloon of the intra-aortic balloon catheter after stopping only the assisted circulation by PCPS.

[0007] Therefore, an object of the present invention is to provide a blood assisting circulation device capable of more efficiently performing blood assisting circulation. Specifically, the IABP method and the PCPS method are used in combination, and both of them are used. While maintaining the advantages of the above, and solving the above-mentioned problems, further, the auxiliary circulation by the combined use of the IABP method and the PCPS method, the auxiliary circulation by the IABP method alone, P
(EN) Provided is a blood assisted circulation device capable of selectively performing assisted circulation by the CPS method alone, and increasing the amount of blood assisted circulation by an intra-aortic balloon catheter when assisting circulation by the IABP method alone.

[0008]

[Means for Solving the Problems] Achieving the above-mentioned object is to provide an aortic balloon catheter, a blood removal catheter to be inserted into a vena cava, and a downstream side of the aortic balloon catheter in the aorta from the balloon. A blood assisting circulation device having a blood feeding catheter inserted so that the blood feeding port is located in the blood feeding means, a blood feeding means for feeding blood from the blood removal catheter side to the blood feeding catheter side, and an auxiliary circulation control device. The aortic balloon catheter includes a catheter body, a pumping balloon provided near the distal end of the catheter body, and a first blood flow provided on the proximal side of the catheter body with respect to the pumping balloon. An inhibition balloon, a second blood flow inhibition balloon provided on the proximal side of the catheter body with respect to the first blood flow inhibition balloon, and the pumping A first lumen communicating with the balloon; a second lumen communicating with the first blood flow inhibiting balloon; and a third lumen communicating with the second blood flow inhibiting balloon; The control device can select a combined auxiliary circulation for performing auxiliary circulation by the intra-aortic balloon catheter and an auxiliary circulation by the blood feeding means, a single auxiliary circulation for the intra-aortic balloon catheter, and an auxiliary circulation by the blood feeding means. It has an assisted circulation selection function and a blood flow inhibition balloon control function, and the blood flow inhibition balloon control function inhibits one blood flow inhibition balloon at the start of contraction of the other blood flow at the time of the combined assisted circulation. A combined circulation control function that controls to alternately inflate and deflate the two blood flow inhibiting balloons so that the infusion balloon is in an inflated state; A blood circulatory support device having a chromatography emissions catheter alone auxiliary cyclable the balloon for the aorta to the catheter alone circulation time control functions pumping by the blood flow inhibition balloon at.

Further, it is preferable that the control device has a function of selecting the number of balloons to be operated from the two blood flow inhibiting balloons for single circulation of the intra-aortic balloon catheter. Further, the control device has a balloon inflation sequence control function of starting inflation by slightly shifting the inflation start time from the balloon on the proximal side toward the balloon on the distal side during the single circulation of the intra-aortic balloon catheter. Preferably.

It is preferable that the first blood flow inhibiting balloon and the second blood flow inhibiting balloon have a volume when inflated that is smaller than a volume of the pumping balloon when inflated. Further, it is preferable that the outer diameter of the first blood flow inhibiting balloon and the second blood flow inhibiting balloon when inflated is larger than the outer diameter of the pumping balloon when inflated.

The blood supplementary circulation apparatus of the present invention will be described with reference to the embodiments shown in the drawings. As shown in FIG. 3, the blood assisting circulation device 40 of this embodiment includes an intra-aortic balloon catheter 1, a blood removal catheter 11 inserted into the vena cava, and a second blood flow of the intra-aortic balloon catheter 1. Blood supply port 16 downstream of the blocking balloon 5 in the aorta
Has a blood-sending catheter 12 inserted so as to be positioned, a blood-sending means 71 for sending blood from the blood-stripping catheter 11 side to the blood-sending catheter 12 side, an artificial lung 78, and an auxiliary circulation control device 50. ing.

As shown in FIG. 5, which will be described later, according to this blood assisting circulation device, the blood flow morphology of the patient is such that the blood flow inhibiting balloons 4 and 5 of the intra-aortic balloon catheter 1 are blocked.
The upstream side is divided into the upper limb side internal blood circulation route assisted by a pumping balloon, and the downstream side is divided into the lower limb side internal blood circulation route assisted by the blood feeding means. . In other words, the upper limb side is IAB
The auxiliary circulation is performed by the P method, and the lower limb side is supplemented by the PCPS method including a blood supply catheter, a blood removal catheter, a blood supply means, and an artificial lung.

The aortic balloon catheter 1 includes a catheter body 2, a first balloon, a pumping balloon 3 (main balloon 3), and a second balloon, a blood flow inhibiting balloon 4 (a first blood flow inhibiting balloon 4). , Sub-balloon 4), third balloon 5 for blood flow inhibition
(Second blood flow inhibiting balloon 5, sub-balloon 5), hub 6, and connecting tubes 23, 24, 25.

To be more specific, the aortic balloon catheter 1 of the embodiment shown in FIG. 1 is as shown in FIG.
The catheter body 2 has three balloons 3, 4 and 5 on the outer circumference thereof, and the catheter body 2 has only a first lumen 13 communicating only with the balloon 3 and a first blood flow blocking balloon 4 communicating therewith. It has a second lumen 14 and a third lumen 15 which communicates only with the second blood flow blocking balloon 5. Further, as shown in FIG.
Has a fourth lumen 16 in its center for inserting a guide wire when inserting the catheter 1 into a blood vessel and for measuring aortic pressure. The first lumen 13, the second lumen 14, and the third lumen 15 are in communication with the catheter-side connection tubes 23, 24, 25 connected to the hub 6, respectively. Further, the connection tubes 23, 24, 25 are respectively connected with connectors 27, 28, 29 for connection with balloon tubes for aortic balloon catheter control device side connection tubes described later.
Is provided.

The catheter body 2 is preferably one having a certain degree of flexibility. For example, a polyolefin (eg, polyethylene, polypropylene, ethylene-
Propylene copolymer, ethylene-vinyl acetate copolymer, etc.), polyvinyl chloride, polyimide, thermoplastic resin such as polyurethane, polyamide elastomer, silicone rubber, latex rubber, etc. can be used, preferably the above-mentioned thermoplastic resin. , And more preferably polyurethane. The length of the catheter body 2 is 200-60
0 mm, more preferably 450-550 mm, outer diameter 1.0-5.0 mm, more preferably 1.15-
The thickness is 4,0 mm and the wall thickness is 0.1 to 0.4 mm, more preferably 0.15 to 0.25 mm.

The tip 10 of the catheter body 2 is
It functions as a guide for the catheter 1, and is provided so that the tip of the catheter 1 does not damage the blood vessel wall during insertion into the blood vessel. For this reason, the distal end portion 10 of the catheter body 2 is formed into a rounded, hemispherical curved surface. Furthermore, it is preferable that the position of the tip portion 10 can be easily confirmed under fluoroscopy. Therefore, Pt, Pt alloy, W, W alloy,
Embedding a metal member formed of Ag, Ag alloy, or the like,
Alternatively, metal powder may be mixed.

The pumping balloon 3, the blood flow inhibiting balloon 4, and the blood flow inhibiting balloon 5 can be inflated and deflated, and these balloons 3, 4, and 5 are placed on the outer circumference of the catheter body when deflated. It is configured so that it can be in a close contact or folded state. The material of the balloons 3, 4, and 5 is preferably one having a certain degree of plasticity and a hardness that can suppress a significant volume change due to the driving fluid pressure or blood pressure. For example, polyethylene,
Polypropylene, polyolefin such as ethylene-propylene copolymer, polyester such as polyethylene terephthalate, polyvinyl chloride, ethylene-vinyl acetate copolymer, crosslinkable ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer,
Silicone rubber, latex rubber, etc. can be used.

Further, as the material of the inhibition balloon,
When the balloon is inflated and brought into close contact with the blood vessel, it is preferable that the compliance is larger because the blood vessel is not excessively stressed and the deflated state lasts for a long time. That is, a softer material than the balloon 3 is preferable. Both ends of each of the balloons 3, 4, and 5 are fixed to the outer peripheral surface of the catheter body 2 by, for example, bonding. In addition, the insides of the balloons 3, 4, and 5 communicate with the lumens 13, 14, and 15 through the openings 33, 34, and 35 provided on the outer surface of the catheter body 2, respectively. The expansion fluid can flow into the inside.

In the embodiment shown in FIG. 1, the pumping balloon 3 has a larger volume, and the blood flow inhibiting balloons 4 and 5 are smaller in volume than the pumping balloons. By doing so, the driving fluid can be easily sent and discharged when the inhibition balloon is inflated and deflated, and the lumen 1 communicating with the inhibition balloons 4 and 5 is provided.
It is possible to make 4 and 15 thin, and it is possible to suppress an increase in the outer diameter of the catheter even with a multi-chamber balloon. Further, sufficient auxiliary circulation can be performed without excessively increasing the total volume of the balloon. Further, since the contact area between the inhibiting balloon and the blood vessel can be reduced, stress on the blood vessel is reduced and branch blood vessel occlusion can be suppressed. In this way, when increasing the volume of the pumping balloon, the volume of the pumping balloon: the volume of one blood flow inhibiting balloon = 2.
It is preferably about 20: 1, and more preferably
It is 5 to 20: 1, and particularly preferably 10 to 20: 1. Further, the volumes of the two blood flow inhibiting balloons may be, for example, the volume of the first blood flow inhibiting balloon larger than the volume of the second blood flow inhibiting balloon, and vice versa. The volume of the balloon may be larger than the volume of the first blood flow blocking balloon. Further, the balloons 3, 4, and 5 may all have the same volume.

Specifically, the balloons 3, 4, and 5 have a size such that the outer diameter of the cylindrical portion when inflated is 12 to 1
It is 7 mm, preferably 15 to 16 mm. Further, the length of the main balloon is preferably 180 to 300 mm, and the length of the inhibition balloon is preferably about 8 to 75 mm. Also,
The total volume of the balloon is preferably 20 to 40 ml. In the case of children, the balloons 3, 4, and 5 have an outer diameter of 4 to 12 m when inflated.
m, preferably 4 to 10 mm. The length of the main balloon is preferably 60 to 200 mm, and the length of the inhibition balloon is preferably 3 to 50 mm. The total volume of the balloon is preferably 1 to 10 ml.

Further, the first and second blood flow inhibiting balloons 4 and 5 are formed to have a larger outer diameter when inflated than the pumping balloon 3. In this way, by making the outer diameter at the time of inflation larger than that of the pumping balloon, resistance is given to the blood flowing through the gap between the blood vessel and the inhibition balloon,
It is possible to prevent the blood from the blood supply catheter side, which will be described later, from flowing to the distal end side of the balloon catheter, and also to prevent the blood due to the operation of the pumping balloon from flowing to the proximal end side of the blood supply catheter. In addition, the inhibition balloon may not adhere to the blood vessel.In this case, an excessive imbalance occurs in the pressure balance between the upper limb side internal circulation circuit and the lower limb side internal circulation circuit, or the pressure in the upper limb due to heart recovery. When it rises excessively, blood is allowed to flow through the gap between the blocking balloon and the blood vessel.

Furthermore, two blood flow blocking balloons 4, 5
Preferably adheres to the inner wall of the blood vessel at the time of expansion and can block the blood vessel. By doing so, it is possible to reliably prevent the blood from the blood supply catheter side from flowing to the distal end side of the balloon catheter, and also to ensure that the blood due to the operation of the pumping balloon flows to the proximal end side of the blood supply catheter. Can be stopped. Since this catheter has two blood flow inhibiting balloons 4 and 5, even if these are used to substantially occlude the blood vessel when inflated as described above, the two balloons are alternated. By inflating and deflating the same, it is possible to prevent the same blood vessel wall from constantly adhering to the balloon. Therefore, excessive stress is applied to the blood vessel, and even if there is a blood vessel branching from the aorta near the blood flow blocking balloon, the blood vessel is not always occluded.

Further, at the start of deflation of one of the blood flow inhibiting balloons, at least the other blood flow inhibiting balloon is controlled to be in an inflated state, thereby suppressing the movement of the intra-aortic balloon catheter. You can The outer diameter of the blood flow inhibiting balloon is preferably about 1 to 5 mm larger than the outer diameter of the pumping balloon.

As the blood feeding means 71 used in the blood supplementary circulation device 40 of the present invention, a constant pressure pump means, a roller pump, a peristallic pump or the like can be used. Preferably, it is a constant pressure pump means, and the constant pressure pump sends the fluid at a constant pressure. The constant pressure pump means includes a constant pressure pump and a motor for driving the constant pressure pump. As the constant pressure pump, a centrifugal pump, a turbine pump, a screw pump or the like can be used. In the apparatus of the embodiment shown in FIGS. 3 and 4, the blood feeding means 71 is composed of a constant pressure pump 72 and a motor 73 for driving this constant pressure pump.

The artificial lung 78 may be any type of artificial lung, preferably a membrane oxygenator, and particularly preferably a hollow fiber membrane oxygenator. As a hollow fiber membrane type artificial lung, a housing, a gas exchange hollow fiber membrane which is a blood processing member inserted in the housing, and both ends of the hollow fiber membrane bundle are liquid-tightly fixed to both ends of the housing. Gas that is a blood processing fluid that is provided near the partition wall and both ends of the housing and that communicates with the space (oxygen chamber) formed by the outer surface of the hollow fiber membrane that is the blood processing member, the inner surface of the housing, and the partition wall. , And a gas outflow port, and a blood inflow port having a blood inflow port and a blood outflow port having a blood outflow port respectively attached to both ends of the housing. As a hollow fiber bundle housed in a cylindrical housing, a bundle of about 10,000 to 60,000 gas exchange hollow fiber membranes is used. Is a porous film and has a large number of fine pores penetrating therethrough. The hollow fiber membrane for gas exchange has an inner diameter of 100 to 1
000 μm, preferably 100 to 300 μm, wall thickness 5 to
80 μm, preferably 10-60 μm, porosity 20-8
0%, preferably 30 to 60%, and fine pores having a diameter of 0.01 to 5 μm, preferably about 0.01 to 1 μm are suitably used. Further, it is not limited to the hollow fiber membrane and may be a flat membrane. As a material for the hollow fiber membrane for gas exchange, a polymer material such as polypropylene, polyethylene, polytetrafluoroethylene, polysulfone, polyacrylonitrile, or cellulose acetate can be used.
A hydrophobic polymer is preferable, a polyolefin resin is particularly preferable, a polypropylene is more preferable, and a polypropylene having fine pores formed by a stretching method or a phase separation method is desirable.

The blood removal side blood tube 74 is provided with the blood removal catheter 11 on the tip side, and the constant pressure pump 72 is provided on the other end.
It is connected to the. The tip of the blood supply side blood tube 75 is connected to the artificial lung 78, and the blood supply catheter 12 is attached to the rear end. A connector 31 with the blood tube 74 is provided at the proximal end of the blood removal catheter 11, and a connector 31 is also provided with the blood tube 74.
A connector 76 is provided for connection with the. Similarly, the proximal end portion of the blood supply catheter 12 is also provided with the connector 32 with the blood tube 75, and the blood tube 75 is also provided with a connector 77 for connecting with the connector 32. Blood removal catheter 11, blood supply catheter 1
2. As the blood removal side blood tube 74 and the blood supply side blood tube 75, for example, transparent flexible synthetic resin tubes such as vinyl chloride resin and silicone rubber can be preferably used.

Further, a flow meter may be attached to any of the blood tubes 74 and 75. This is because it is difficult to confirm the flow rate from the number of rotations of the pump when a constant pressure pump, particularly a centrifugal pump is used, and it is preferable to provide it for confirming the flow rate. The flow meter is preferably one capable of measuring the flow rate of blood flowing inside the blood supply vessel without directly contacting with blood, and for example, an ultrasonic flow meter, an electromagnetic flow meter or the like is preferably used.

Further, the blood auxiliary circulation device 40 of the present invention
It is preferable that blood circulation be possible without using an anticoagulant. For this reason, the anti-thrombotic property is provided on the blood contact surface in the blood assisted circulation circuit, especially on the blood contact surfaces of the artificial lung 78, the blood tubes 74 and 75, the blood supply catheter 11, the blood removal catheter 12, and the intra-aortic balloon catheter 1. It is preferable to fix the material. Antithrombotic materials include heparin,
Polyalkyl sulfone, ethyl cellulose, acrylic acid ester-based polymer, methacrylic acid ester-based polymer (for example, poly HEMA [polyhydroxyethyl methacrylate]), block or graft copolymer having both hydrophobic segment and hydrophilic segment (For example, a block copolymer of HEMA-styrene-HEMA, a block copolymer of HEMA-MMA [methyl methacrylate], a block copolymer of HEMA-LMA [lauryl methacrylate], PVP [polyvinylpyrrolidone] -MMA Block copolymer, HEMA-M
A block copolymer of MA / AA [acrylic acid], a blend polymer obtained by mixing a polymer having an amino group with the block copolymer, and a fluorine-containing resin can be used. Preferably HEMA-styrene-HEMA
Block copolymer of HEMA-MMA [methyl methacrylate], HEMA-MMA /
AA [acrylic acid] block copolymer and the like are preferable. Then, it is preferable to coat the blood contact surface with a hydrophilic resin other than heparin described above, and then further fix heparin thereon. In this case, in order to fix heparin on the surface of this hydrophilic resin, the hydrophilic resin has a hydroxyl group, an amino group, a carboxyl group, an epoxy group, an isocyanate group, an epoxy group, a thiocyanate group, an acid chloride group, an aldehyde group and It is preferable to have any of the carbon-carbon double bonds or a group that can be easily converted into these groups. It is particularly preferable to use a blended polymer in which the hydrophilic resin is mixed with a polymer having an amino group. As the polymer having an amino group, polyamine, particularly PEI [polyethyneimine] is preferable.

Heparin fixation is carried out by coating the above-mentioned hydrophilic resin on the blood contact surface of the blood auxiliary circulation circuit, and then contacting the surface with an aqueous solution of heparin, and then aldehydes such as glutaraldehyde, terephthalaldehyde and formaldehyde. Diphenylmethane diisocyanate, 2,
By contacting with an immobilizing agent such as 4-tolylene diisocyanate, carbodiimide-modified diphenylmethane diisocyanate, epichlorohydrin, 1,4-butanediol diglycidyl ether, polyethylene glycol diglycidyl ether, covalent bond to the above hydrophilic resin to immobilize be able to.

Next, the auxiliary circulation control device 50 used in the blood auxiliary circulation device of the present invention will be described with reference to FIGS. 3 and 4. The control device 50 includes three lumens 13, 14,
At least the pump means 58 capable of independently circulating the fluid to the unit 15 and the controller 55 of the pump means 58 are provided. Specifically, as shown in FIGS. 3 and 4, the control device 50 includes a controller 55, a switch panel 56,
Indicator 57, pressure generation pump (balloon inflation / deflation pump) 59, pumping balloon drive control valve 60, first blood flow inhibition balloon drive control valve 61, second blood flow inhibition balloon drive control valve 62. , And has a motor driver 54. Then, a pressure generating pump (balloon inflation / deflation pump) 59, a pumping balloon drive control valve 6
0, the first blood flow inhibiting balloon drive control valve 61, and the second blood flow inhibiting balloon drive control valve 62 constitute pump means 58. Further, the control valve 60 has a first
The catheter connecting tube 63 of the
The second catheter connecting tube 64, and the control valve 62 further includes a third catheter connecting tube 65.
The tubes are connected, and connectors 66, 6 for connecting to the connectors 27, 28, 29 of the catheter are connected to these tubes.
7, 68 are attached. And when used,
An electrocardiograph 51, an aortic pressure sensor 52, and a flow rate sensor 53 (attached to the blood flow sensor 53, the blood tube 74 or 75) are connected to the control device 50. All of these may be considered as a control device.

Then, the controller 55 uses combined auxiliary circulation (IABP / PCPS combined mode) for performing auxiliary circulation by the intra-aortic balloon catheter and auxiliary circulation by the blood supply means.
And a single balloon catheter for aorta (IA)
BP single mode) and blood supply means single auxiliary circulation (PCPS)
It has an auxiliary circulation selection function (mode selection function) that can select the single mode) and a blood flow inhibition balloon control function. Then, the blood flow inhibiting balloon control function is configured such that, during the combined auxiliary circulation, the other blood flow inhibiting balloon is inflated when the contraction of one of the blood flow inhibiting balloons starts.
Intra-aortic balloon catheter that allows control by the combined circulation control that alternately inflates and deflates two blood flow blocking balloons, and pumping by the blood flow blocking balloon during single auxiliary circulation of the aortic balloon catheter It has a control function for independent circulation. Further, it is preferable that the control function at the time of combined use has a function of controlling such that when one of the blood flow inhibiting balloons starts to deflate, the other balloon is in an inflated state. In addition, the control device, for the single circulation of the balloon catheter for the aorta,
The function to select the number of balloons to be operated from the two blood flow obstruction balloons, and the expansion start time is slightly shifted toward the distal balloon from the balloon on the proximal side during single circulation of the aortic balloon catheter It has a balloon inflation sequence control function to start the.

Further, the control device has a blood flow inhibiting balloon control function for operating the blood flow inhibiting balloon as a blood flow inhibiting balloon in response to the operation of the pumping balloon and the blood sending means. In other words, the blood flow blocking balloons 4 and 5 are operated as blood flow blocking balloons except in the combined auxiliary circulation (IABP / PCPS combined mode) in which the auxiliary circulation by the balloon catheter for the aorta and the auxiliary circulation by the blood supply means are performed. It has a function to control not to let it.

Then, the controller 55 sends a signal calculated based on the electrocardiogram waveform output from the electrocardiograph 51 to the control valve 60 to open / close the control valve.
The inflation / deflation timing of the balloon 3 is controlled. That is, it has a function of expanding and contracting the pumping balloon 3 in synchronization with the heartbeat. Specifically, the electrocardiograph 5
The P wave, R wave, and T wave can be confirmed from the electrocardiogram waveform that is an electrical analysis of the heartbeat input from 1. However, it is the R wave that has the highest electrical output that can be easily electrically extracted. The relationship between the movement of the heart and each of the above waves is said to be such that the aortic valve opens near the P wave and the aortic valve closes near the T wave. That is, the blood flow in the heart starts near the P wave, ends near the T wave, and no blood flows from the T wave to the P wave. The R wave is generated later than the P wave.

That is, most of the coronary blood flows during the diastole of the heart, so that blood can be reliably sent to the coronary arteries by increasing the aortic pressure when the aortic valve is closed. Conversely, when the aortic valve is open, that is, when the left ventricle contracts and discharges blood flow (to distinguish it from blood flowing back from the vein to the heart), auxiliary circulation If you don't send blood from the left ventricle, you won't strain the left ventricle. If the balloon of the intra-aortic balloon catheter 1 is inflated while the aortic valve is closed, the diastolic pressure can be further increased and blood can be sent to the coronary arteries. Conversely, if the balloon is deflated when the aortic valve is open, that is, when the blood flow is being pumped by the heart, the work load for the heart to pump blood is reduced. be able to.

As for the inflation timing of the pumping balloon, the T wave may be detected and output. However, as described above, since the R wave is detected most reliably, the T wave ( It is preferable to calculate a pseudo T wave. Specifically, the interval from the R wave to the T wave does not change much due to fluctuations in the heart rate, so a signal delayed by a predetermined time from the R wave detection (pseudo T wave signal) is used as an inflation start signal (the inside of the balloon is positive). (A signal for operating the control valve 60 so that the pressure is maintained)
As a result, the balloon can be inflated in accordance with the occlusion of the aortic valve. In addition, the balloon deflation timing may be a predetermined number (for example, the latest 5
The average value is calculated from the R wave
The generation cycle of the R wave is constantly calculated, and a pseudo P wave that is appropriately delayed from the pseudo T wave is calculated from the calculated cycle and the generation timing of the pseudo T wave (open signal), and this is calculated as a balloon deflation start signal (balloon). It is configured to output as a signal for operating the control valve 60 so that the inside becomes a negative pressure state). That is, this occlusion signal is output almost in synchronization with the opening of the aortic valve. Further, the inflation of the pumping balloon 3 does not have to be performed by the same number as the heart rate, and for example, the pseudo T-wave signal is input once every several times, for example, 1 to 8 times.
You may make it expand once.

The mode selection function of the controller will be described. As described above, the mode selection function is a function capable of selecting a means for performing blood assisted circulation from three ways. This is the IABP.P provided on the switch panel 54.
CPS mode switch, IABP single mode switch,
It can be selected by turning on one of the PCPS single mode switches, and the controller 55 can be selected in the selected mode.
, But blood-assisted circulation.

Next, the balloon control function for blood flow inhibition will be described. The control device 50 has a blood flow inhibition balloon control function for operating the blood flow inhibition balloon as a blood flow inhibition balloon in response to the operation of the pumping balloon and the blood supply means. In other words, this blood flow inhibition balloon selection function is performed by the blood flow inhibition balloon 4 except in the combined auxiliary circulation (IABP / PCPS combined mode) in which the auxiliary circulation by the intra-aortic balloon catheter and the auxiliary circulation by the blood sending means are performed. , 5 has a function of controlling so as not to operate as a blood flow inhibiting balloon. This feature
It is also effective when any of the assisted circulation is stopped due to some reason (for example, a sudden change in the patient's condition or a defective device) while performing both the assisted circulation by the IABP and the assisted circulation by the PCPS. is there. Without such a function, if the blood flow inhibiting balloon is constantly inflated during assisted circulation by only the pumping balloon (during IABP alone assisted circulation), blood is substantially downstream from the blood flow inhibiting balloon. To the PCP and vice versa
When the blood flow inhibiting balloon is constantly inflated during the auxiliary circulation of S alone, the blood flow pumped by the heart from the upstream side of the blood flow inhibiting balloon is substantially blocked, and PC
The flow of blood flow upstream of the PS blood flow blocking balloon is also blocked.

Furthermore, the balloon control function for blood flow inhibition is
One blood flow blocking balloon (for example,
At the start of the deflation of the balloon 4), the two blood flow inhibiting balloons (for example, the balloon 5) are controlled to be alternately inflated and deflated so that the other blood flow inhibiting balloon is in an inflated state. Specifically, in this function, the pump 59
The control valves 61 and 62 are controlled as follows. Controller 5
5 is a cycle longer than the inflation / deflation cycle of the pumping balloon regardless of the inflation timing of the pumping balloon (that is, at a timing different from the inflation timing of the pumping balloon). Repeat alternating expansion and contraction of 5. The inflation / deflation cycle of the blood flow inhibiting balloons 4 and 5 is preferably synchronized with the heartbeat at the shortest to about 300 seconds at the longest. Further, this function preferably has at least a function of controlling any of the blood flow inhibiting balloons to be in an inflated state. Specifically, one of the blood flow inhibiting balloons 4 is inflated and, after a lapse of a predetermined time, before starting to contract, the other blood flow inhibiting balloon 5 is inflated and is in an expanded state. To control the balloon 5 as well
However, after the predetermined time has elapsed and before the balloon 4 is inflated, the balloon 4 is inflated and is in an inflated state. Control to stay. In this manner, at the start of deflation of one of the blood flow inhibiting balloons, at least the other blood flow inhibiting balloon is controlled to be in an expanded state, whereby the movement of the intra-aortic balloon catheter can be suppressed. .

The blood flow inhibiting balloon control function has a control function for intra-aortic balloon catheter single circulation which enables pumping by the blood flow inhibiting balloon during intra-aortic balloon catheter single auxiliary circulation. .
Further, in relation to this function, the controller has a function of selecting the number of balloons to be operated out of the two blood flow inhibiting balloons, and slightly inflating the inflation start timing toward the distal balloon to start inflation. It has a balloon inflation sequence control function.

Specifically, the controller 55 inhibits blood flow when the blood auxiliary circulation device is used as an auxiliary circulation device by IABP alone (when the IABP single mode switch of the switch panel is turned on). Balloon 4,
5 is inflated and deflated in synchronization with the pumping balloon,
It has a function of operating as the second and third IABP balloons. In this way, a blood flow blocking balloon is attached to the IAB.
If it can be operated as a balloon for P, IA
The auxiliary effect of BP increases. As for the number of blood flow blocking balloons used as pumping balloons, when the triple balloon switch on the switch panel is turned on, all three balloons are operated for pumping, and the double balloon switch on the switch panel is turned on. By doing so, the two balloons (main balloon 3 and sub balloon 4) operate for pumping. Then, when the IABP start switch is turned on without turning on the triple and double balloon switches, pumping is performed only by the main balloon 3.

As described above, the pumping can be performed by selecting an arbitrary number of balloons, so that the balloon pumping can be finished stepwise. In addition, for example, the recovery state of the heart function of the patient can be confirmed by stopping the inflation / deflation of one sub-balloon and reducing the auxiliary circulation amount by balloon pumping. Specifically, when the recovery of the cardiac function is seen from the patient's condition in consideration of the patient's aortic pressure, blood flow, etc., the control device of the present invention can perform the gradual termination.
For example, while balloon pumping was performed in a triple balloon mode in which all three balloons are operated, for example, the operation of the second blood flow inhibiting balloon is stopped and the main balloon 3 and the first blood flow inhibiting balloon are stopped. Four
By this, balloon pumping is performed. This also
If the patient's condition is stable, whether to continue it or to stop the operation of the second blood flow blocking balloon 5 is examined. When it is considered that the second sub balloon 5 may be stopped, balloon pumping is performed only by the main balloon 3. And this also
If the patient's condition is stable, consider continuing it, activating only balloons 4 and 5 and ending balloon pumping, and if possible, balloon pumping. finish.

Next, the balloon inflation sequence control function will be described. When performing balloon pumping using all of the balloons 3, 4, and 5 (triple balloon mode), the controller 55 first starts the inflation of the second blood flow inhibiting balloon 5 located at the most proximal side. The first blood flow obstruction balloon 4 starts to inflate slightly later than the start of inflation of the second blood flow obstruction balloon 5, and the pumping starts slightly later than the start of inflation of the first blood flow obstruction balloon 4. Pump and control valve 6 so that the balloon 3 begins to inflate
0, 61, 62 are controlled. Further, when performing balloon pumping using only the balloons 3 and 4 (double balloon mode), the controller 55 starts the inflation of the first blood flow inhibiting balloon 4, and the first blood flow inhibiting balloon. The inflation order of the balloons is controlled so that the balloons 3 begin to inflate slightly later than the inflation start of Step 4. In this way, when performing balloon pumping using a plurality of balloons, the controller 55 ensures that the blood flow is directed toward the heart side in order to start the inflation from the proximal balloon as described above. Can be sent to, and less likely to cause backflow.

As a specific method of balloon inflation start timing, as described above, the balloon to be first inflated by the inflation start signal (pseudo T wave signal) calculated from the electrocardiogram waveform (for example, in the triple balloon mode) In this case, inflate the second blood flow blocking balloon 5),
That is, the pseudo T-wave signal is used as the inflation start signal of the proximal side balloon (the second blood flow blocking balloon), and delayed by, for example, 10 to 200 ms from the pseudo T-wave signal,
A second inflation start signal is sent to the first blood flow obstruction balloon 4
Start to expand. Then, the third inflation start signal is sent with a delay of 10 to 200 ms from the second inflation start signal to start inflation of the main balloon 3. Also, the third
The expansion start signal may be generated 20 to 40 ms after the pseudo T wave signal as a reference. When these expansion start signals are input to the control valves 60, 61, 62, the control valves 60, 61, 62, 61, 62 are controlled so that the air supplied from the pump 59 flows into the balloon and the balloon has a positive pressure.
Two solenoid valves provided in 62 are activated. Then, as described above, the controller 55 operates to deflate all the balloons 3, 4, 5 by the deflation start signal (pseudo P wave signal) calculated from the electrocardiogram waveform. When these contraction start signals are input to the control valves 60, 61, 62, the pump 59 exhausts the gas flowing into the balloon so that the inside of the balloon becomes a negative pressure.
Two solenoid valves provided in 1, 62 are operated.

Further, the deflation start signal may be output with a time difference provided for each balloon, similarly to the inflation start signal described above. In this case, first, the deflation of the main balloon 3 is started, and then the first sub balloon 4 and the second sub balloon 5 are controlled to deflate. By doing so, the afterload reduction effect at the time of cardiac output is increased. Further, the controller 55 has a cardiac function recovery confirmation function. This heart function recovery function is P
It operates when the CPS start switch is turned off. When the PCPS start switch is turned off, the controller 55 gradually reduces the blood volume by the centrifugal pump and brings the inhibition balloon into a deflated state. Then, the aortic pressure is confirmed, and if there is no change, it is determined that the aortic pressure has recovered, and the operation of the centrifugal pump is completely stopped. When the aortic pressure drops, it is judged that the heart function has not recovered, the PCPS start switch is automatically turned on, the centrifugal pump drive motor is activated, and the inhibition balloon is also activated again. Start.

The switch panel 56 includes a power switch, an IABP / PCPS combined mode switch, an IA
BP single mode switch, PCPS single mode switch, triple balloon switch, double balloon switch, IABP start switch, PCPS start switch, PCPS flow rate input switch, pumping balloon inflation pressure input switch, blood flow obstruction balloon inflation pressure input switch, etc. It is provided. In addition, the control device 5
Reference numeral 5 has an alarm 69 that sounds when an abnormality occurs. This alarm is generated, for example, by the controller 55 by the electrocardiograph 51.
Abnormality of the electrocardiogram waveform input by the user, change in the flow rate detected by the flow sensor that exceeds the allowable range (for example, abrupt decrease), change in the aortic pressure detected by the aortic pressure sensor that exceeds the allowable range (for example, abrupt Sound), and sounds when an abnormality is detected in the controller, pump, control valve, driver, etc.

The control valves 60, 61, 62 each have two solenoid valves inside, and the pressure from the pressure generating pump can be switched between positive pressure and negative pressure by operating the two solenoid valves. Is used. Further, the pressure is not limited to this, and at least any pressure can be used as long as the pressure from the pressure generating pump can be switched to positive pressure and negative pressure.

The motor driver 54 also includes a controller 55.
Based on the signal to be output more, the pump motor 73
To rotate. The rotation of the motor 73 is transmitted to the centrifugal pump 72, the rotor in the centrifugal pump rotates, and blood is sent from the blood removal catheter side to the blood sending catheter side.
The blood flow value detected by the blood flow sensor 53 is input to the controller 55. The controller 55 calculates the motor driver 54 based on the calculated value in consideration of the flow rate input by the PCPS flow rate input switch provided on the switch panel 56 and the flow rate detection signal detected by the blood flow sensor 53.
May have a function of outputting a rotation signal of the pump motor. By doing so, the auxiliary circulation amount by PCPS can be automatically controlled in consideration of the blood flow amount detected by the blood flow meter 53. An ultrasonic flow rate sensor, an electromagnetic flow rate sensor, or the like can be used as the blood flow sensor. The motor may be an AC motor or a DC motor, but a variable speed motor is preferable. Further, it is preferable that the flow rate be easily controlled, and for example, a stepping motor which is an AC motor is preferable. And the motor driver depends on the motor used,
It can output voltage, current and pulse variably. Specifically, if the motor is a stepping motor, a motor driver that can variably output the number of pulses within a predetermined time is used.

The aortic pressure detected by the aortic pressure sensor 52 is input to the controller 55. The controller 55 is
A function of appropriately adjusting the inflation pressure of the balloon for pumping is provided based on a calculated value in consideration of the pressure value input by the balloon inflation pressure input switch for pumping provided on the switch panel 56 and the detected aortic pressure. May be. By doing this, the IABP is set at the optimum pumping pressure in consideration of the blood pressure detected by the aortic sensor.
Auxiliary circulation can be performed by. A semiconductor pressure sensor (for example, a diffusion type semiconductor pressure sensor) can be used as the aortic pressure sensor.

As the pressure generating pump, pressure, for example,
Known materials can be used as long as they can discharge or suck gas or liquid. For example, an air compressor. Specifically, an air compressor or a vacuum pump can be used. On the display 57,
A pumping balloon operating pressure display unit, a blood flow inhibition balloon operating pressure display unit, a flow rate display unit detected by a flow sensor, an aortic pressure display unit detected by an aortic pressure sensor, an auxiliary circulation amount display unit by PCPS, etc. are provided. Has been.

[0050]

The operation of the blood assisting circulation system of the present invention will be described with reference to FIGS. First, as shown in FIG. 5, the intra-aortic balloon catheter 1 is inserted into the aorta and connected to the control device 50. Then, the blood removal catheter 11 is inserted through the femoral vein and left in the vicinity of the right atrium. further,
The blood supply catheter 12 is inserted into the aorta, and its blood outlet is located downstream of the blood flow blocking balloon 5 of the intra-aortic balloon catheter 1. As shown in FIG. 3, each catheter 11, 12 is connected to a tube 74, 75. In this state, the power switch (not shown) provided on the switch panel 56 of the control device 50 is turned on. As a result, an electrocardiogram waveform is input from the electrocardiograph 51 to the controller 55 of the control device 50, and the controller 50 outputs the balloon inflation start signal (pseudo T wave signal) and the deflation start signal (pseudo P wave signal) based on the electrocardiogram waveform. ) Is output. Also,
The data detected by the aortic pressure sensor 52 and the flow sensor 53 is displayed on the display 57.

As shown in the flow chart of FIG. 6, when the IABP / PCPS combined mode switch is turned on, is there any change in the inflation pressure of the pumping balloon stored in advance (provided on the switch panel 56? If the pump inflation pressure change switch for pumping is pressed and a new set pressure is input with the numeric keypad, and if the set pressure is changed, the controller 55 stores the input set pressure and the display 57 Is displayed, and the pumping balloon is inflated by this set pressure. And
Is there any change in the inflation pressure of the blood flow obstruction balloon stored in advance (whether the blood pressure obstruction balloon inflation pressure change switch provided on the switch panel 56 has been pressed and a new set pressure has been input using the numeric keypad). ), And if the set pressure is changed, the controller 55 stores the input set pressure and displays it on the display 57.
It is determined whether there is a change in the flow rate (whether the PCPS flow rate change switch provided on the switch panel 56 has been pressed and a new flow rate has been entered using the numeric keypad). If there is a change in the flow rate, the entered flow rate is controlled by the controller. 55 is stored and displayed on the display 57, and blood assist circulation described below is performed at these set pressures and set flow rates.

The IAB on the switch panel 56
When the P start switch is turned on, the pump 59 operates and the controller 55 controls the control valve 60 so as to repeatedly inflate and deflate the pumping balloon 3. The blood flow blocking balloon does not expand only when the IABP start switch is turned on. And PCP
S start When the start is turned on, the controller 55 controls the control valve 61 to inflate the blood flow obstruction balloon 4 and sends a signal to the motor driver 54 so that the motor drive signal corresponding to this signal is sent. It is sent from the driver 54 to the pump motor 73, the motor 73 rotates, this rotation is transmitted to the pump 72, and blood is sent from the blood removal catheter to the blood sending catheter side. The sent blood flows out of the blood sending catheter and flows into the aorta. The blood flow-inhibiting balloon prevents the inflowing blood from substantially flowing to the upstream side of the aorta (pumping balloon side) and reliably flows to the downstream side of the aorta, that is, the lower limb side. Further, the blood flow created by the operation of the pumping balloon is substantially blocked from flowing to the downstream side of the aorta by the blood flow inhibiting balloon, and reliably flows to the upstream side of the aorta, that is, the upper limb side. As described above, the blood flow by the pumping balloon (IABP) and the blood flow by the pump (PCPS) are separated by the blood flow inhibition balloon, and both the blood flows of the two may collide with each other or may be mixed. There is no way. Therefore, the effects of reducing the afterload (resistance at the time of pumping blood) and increasing the aortic pressure by increasing the coronary blood flow by the IABP method are maintained, and further, the preload (blood returning to the heart by the PCPS method is maintained. The effect of reducing the fluid pressure) and maintaining (increasing) the extracorporeal circulation blood flow can be maintained, and blood assist circulation with the advantages of both can be performed.

Further, by the operation of the centrifugal pump 72, the blood passes through the blood removal side tube 74 and is sent to the centrifugal pump 72 and the artificial lung 78, where oxygen addition and removal of carbon dioxide to the blood are carried out. After being performed, the balloon 5 (the second proximal end side of the intra-aortic balloon catheter 1 (the second side) is passed through the blood feeding side tube 75 and the blood feeding catheter 12.
It flows downstream from the blood flow inhibiting balloon) and near the blood flow inhibiting balloon 5. And during the operation of the pumping balloon, blood flow blockage balloon, centrifugal pump,
Determine if there are any abnormalities. The abnormality is determined by, for example, a decrease in aortic pressure, a decrease in blood flow, an error in the controller, or the like. When it is determined that there is an abnormality, an alarm sounds and abnormality processing is performed. Then, considering the recovery state of the patient, PCPS
By turning off the start switch, the operations of the blood flow blocking balloon and the centrifugal pump are stopped. In addition, PC
When the PS start switch is turned off, the controller has a cardiac function recovery confirmation function for gradually reducing the blood volume by the centrifugal pump and keeping the blocking balloon in a deflated state. As a result, when the blocking balloon is deflated and the pump flow rate is reduced, blood removal from the heart is also reduced, which increases the preload. If the cardiac function is restored, this load can be overcome and the heart can be ejected, so that the arterial pressure of the upper limb is maintained and the hemodynamics of the living body are maintained. If the cardiac function is not recovered, the arterial pressure in the upper limbs is reduced due to the low ejection ability, and it is not time to end the PCPS assist. For this reason, the controller has a cardiac function recovery confirmation function. When the PCPS start switch is turned off, the controller enters the cardiac function recovery confirmation mode, and gradually reduces the blood volume by the centrifugal pump as described above. The aortic pressure is checked with the blocking balloon deflated, and if there is no change (when it has recovered), the operation of the centrifugal pump is completely stopped.
When the aortic pressure drops, PCPS is automatically
The start switch is turned on, the centrifugal pump drive motor is activated, and the obstruction balloon is also activated.

When the recovery is confirmed by the cardiac function recovery confirmation function of the controller and the operation of the centrifugal pump is stopped, the triple balloon switch is automatically turned on as shown in FIG. The flow-blocking balloons 4 and 5 start operating as pumping balloons, and the balloon 3 continues operating. When the triple balloon switch is turned off or the double balloon switch is turned on, only the blood flow inhibiting balloon 5 is stopped. When the automatic operation frequency control switch on the switch panel 56 is turned on, the control device 50 gradually reduces the balloon operation frequency with respect to the heart rate from 1: 1 to 8: 1. In addition, when the above-mentioned switch is turned on or off, the cardiac function recovery confirmation function operates in the same manner as described above in each mode, and the aortic pressure is confirmed, and if there is no change (when it has recovered) To continue the selected mode. Also, when the aortic pressure drops, it automatically returns to the previous mode. For example, when the automatic operation frequency control switch is turned on, the aortic pressure is confirmed, and if there is no change (when it is recovered), the operation frequency controller mode is continued, and the aortic pressure has decreased. in case of,
The balloon 3 automatically returns to the normal auxiliary mode. Then, when the IABP start switch is turned off, the operation of the pumping balloon is stopped, the blood flow assisting circulation work is completed, and the balloon catheter 1, the blood removal catheter 11, and the blood supply catheter 12 are removed from the patient, Finish the procedure.

If the combined mode switch in FIG. 6 is not turned on, the process moves to that in FIG. 8, and if the IABP single mode switch is turned on, the IABP single mode is started. Also in this case, as shown in the flowchart of FIG. 8, it is determined whether the inflation pressure of the pumping balloon has changed, and if there is a change in the set pressure, the controller 55 stores and displays the input set pressure. Displayed on the container 57,
Judge whether there is a change in the inflation pressure of the blood flow blocking balloon,
If the set pressure is changed, the controller 55 stores the input set pressure and displays it on the display 57. Then, when the triple balloon switch is turned on, the mode is changed to the triple balloon IABP mode (a mode in which pumping is performed using three balloons, that is, a balloon for pumping and two balloons for blocking blood flow), and the IABP start switch is turned on. And the pump operates, and the pumping balloon (main balloon) and the blood flow blocking balloons 4, 5
(Sub-balloons 4, 5) start pumping operation (expansion / contraction). When the double balloon switch is turned on without the triple balloon switch being turned on, the mode is changed to the double balloon IABP mode (a mode in which pumping is performed using two balloons, the pumping balloon and the blood flow obstruction balloon 4). Then, when the IABP start switch is turned on, the pump operates, and the pumping balloon (main balloon) and the blood flow inhibiting balloon 4 (sub balloon 4) start pumping operation (expansion / contraction).

During operation, it is determined whether or not there is an abnormality as described above, and if there is an abnormality, an alarm sounds. Then, when the stop of the blood flow inhibiting balloon (reduction of the auxiliary circulating blood volume) is considered due to the recovery of the patient, the triple balloon switch is turned off or the double balloon switch is turned on. As a result, the above-described cardiac function recovery confirmation function is activated, the aortic pressure is confirmed, and if there is no change (when it has recovered), the selected mode is continued. When the aortic pressure drops, it automatically returns to the previous mode. In this case, the mode returns to the triple balloon IABP mode. When the cardiac function recovery confirmation is performed, the operation of the blood flow inhibition balloon 5 is stopped,
Switch to double balloon mode. Then, as shown in FIG. 9B, the double balloon switch is turned off when the stop of the blood flow inhibiting balloon (further reduction of assistance) is considered due to the recovery of the patient. As a result, the operation of the blood flow inhibiting balloon 4 is stopped, and the pumping balloon 3
Only works. Even in this case, the above-mentioned confirmation of cardiac function recovery is performed. Then, when the automatic operation frequency control switch on the switch panel 56 is turned on, the control device 50 gradually reduces the balloon operation frequency with respect to the heart rate from 1: 1 to 8: 1. Also in this case, the above-mentioned cardiac function recovery confirmation is performed. Then, by turning off the IABP start switch, the operation of the pump and the balloon for pumping is stopped, the blood flow assisting work is completed, and the balloon catheter 1, the blood removal catheter 11, and the blood supply catheter 12 are removed from the patient, Finish the procedure.

If the double balloon switch is turned on without turning on the triple balloon switch as shown in FIG. 8, as shown in FIG.
When the P double balloon mode is entered and the IABP start switch is turned on, the balloons 3 and 4 start the pumping operation. Then, during operation, it is determined whether or not there is an abnormality as described above, and if there is an abnormality, an alarm sounds. When the number of operating balloons is increased depending on the patient's condition, the triple balloon switch is turned on. When the triple balloon switch is turned on, pumping by the blood flow inhibiting balloons 4 and 5 is activated to enter the triple balloon mode, the assist is increased, and the flow shifts to that in FIG. Further, when the double balloon switch is turned off without turning on the triple balloon switch, the above-mentioned cardiac function recovery confirmation function is activated, and when the recovery is confirmed, pumping by the blood flow inhibiting balloon 4 (sub balloon) is performed. It operates and becomes the single balloon mode.
Shift to.

Further, as shown in FIGS. 6, 8 and 10, when the IABP start switch is turned on without turning on the triple balloon switch and the double balloon switch, as shown in FIG.
After shifting to the single mode, only the pumping balloon 3 starts the pumping operation. Then, during operation, it is determined whether or not there is an abnormality as described above, and if there is an abnormality, an alarm sounds. Then, depending on the condition of the patient, when the number of operating balloons is increased, the triple balloon switch or the double balloon switch is turned on. When the triple balloon switch is turned on, the pumping by the blood flow inhibiting balloons 4 and 5 is activated, the triple balloon mode is set, the assist amount is increased, and the process shifts to FIG. Also, without turning on the triple balloon switch,
When the double balloon switch is turned on, pumping by the blood flow blocking balloon 4 (sub balloon) is activated,
The double balloon mode is entered, and the process shifts to that in FIG.

Also, the combined mode switch and IABP
When the PCPS single mode switch is turned on without turning on the single mode switch, the mode shifts to the PCPS single mode as shown in FIG. When the PCPS single mode is entered, as described in the combined mode, P
If there is a change in the CPS flow rate, and if there is a change in the flow rate, the controller 55 stores the input flow rate and displays it on the display 57. Done. Then, when the PCPS start switch is turned on, the motor operates and blood flow assistance by PCPS is started. And during the operation of the motor,
When the IABP / PCPS combined mode switch is turned on, the motor is stopped and the mode is switched to the combined mode from 11 shown in FIG. Further, when the IABP single mode switch is turned on, the motor stops, and as shown in FIG.
The mode shifts to the IABP single mode. Further, while the motor is operating in the PCPS single mode, it is determined whether or not there is an abnormality as described above, and if there is an abnormality, an alarm sounds. When the motor is considered to be stopped due to the recovery of the patient, the motor is stopped by turning off the PCPS start switch, and the blood flow assisting circulation work is completed. 1
Remove 2 to end the procedure.

[0060]

The auxiliary circulatory device of the present invention comprises an intra-aortic balloon catheter, a blood removal catheter to be inserted into the vena cava, and a blood supply port downstream of the balloon of the intra-aortic balloon catheter in the aorta. A blood auxiliary catheter having a blood feeding catheter inserted so that the blood vessel is positioned, a blood sending device for sending blood from the blood removal catheter side to the blood sending catheter side, and a blood circulation auxiliary device having an auxiliary circulation control device. The internal balloon catheter includes a catheter body, a pumping balloon provided in the vicinity of the distal end portion of the catheter body, and a first blood flow inhibiting balloon provided on the proximal side of the catheter body with respect to the pumping balloon. , The first
A second blood flow inhibiting balloon provided on the proximal end side of the catheter body with respect to the blood flow inhibiting balloon, a first lumen communicating with the pumping balloon, and the first blood flow inhibiting balloon. The control device includes a second lumen communicating with the second lumen and a third lumen communicating with the second blood flow inhibiting balloon, wherein the control device assists circulation by the intra-aortic balloon catheter and assists by the blood sending means. A combined auxiliary circulation for performing circulation, an auxiliary circulation for the intra-aortic balloon catheter alone, and an auxiliary circulation selection function capable of selectively selecting the blood supply means auxiliary circulation, and a blood flow inhibition balloon control function. The blocking balloon control function prevents the two blood flow blocking so that the one blood flow blocking balloon is inflated when the one blood flow blocking balloon starts to contract during the combined auxiliary circulation. A control function for combined circulation that controls to alternately inflate and deflate the balloon, and a single circulation balloon catheter for intra-aorta that allows pumping by the balloon for blood flow inhibition during auxiliary circulation of the intra-aortic balloon catheter alone Control function.
Therefore, in these blood assisted circulation devices, the cardiac output blood flow assisted by the pumping balloon (IABP) and the blood flow assisted by the pump (PCPS) are separated by the blood flow obstruction balloon, and both bloods are separated. There is virtually no flow impingement or mixing. Therefore, IAB
The P method has the effect of reducing afterload (resistance at the time of pumping blood), increasing the aortic pressure and increasing the coronary blood flow, and further preloading (the blood pressure returning to the heart) by the PCPS method. And the effect of maintaining (increasing) the extracorporeal circulation blood flow can be maintained, and blood assist circulation having the advantages of both can be performed. Further, since it has two blood flow inhibiting balloons, it is possible to prevent the same blood vessel wall from constantly adhering to the balloon by alternately inflating and deflating these two balloons. Therefore, excessive stress is applied to blood vessels, even if there are blood vessels that branch from the aorta near the location of the blood flow blocking balloon.
It does not block it all the time. Further, blood assisted circulation by the IABP method alone or the PCPS method alone can be performed. In addition, since IABP can perform stepwise assistance, the assistance effect does not sharply decrease, assistance can be provided in accordance with recovery of cardiac function, and withdrawal from IABP is facilitated.

[Brief description of drawings]

FIG. 1 is a side view of an embodiment of the intra-aortic balloon catheter of the present invention.

FIG. 2 is a sectional view taken along line AA of FIG.

FIG. 3 is a schematic view of an embodiment of the blood assisted circulation device of the present invention.

FIG. 4 is a block diagram of an example of a blood assisting circulation control device used in the blood assisting circulation device of the present invention.

FIG. 5 is an explanatory diagram for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 6 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 7 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 8 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 9 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 10 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 11 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

FIG. 12 is a flow chart for explaining the operation of the blood assisting circulation device of the present invention.

[Explanation of symbols]

 1 Balloon Catheter for Aorta 2 Catheter Main Body 3 Pumping Balloon (First Balloon) 4 First Blood Flow Blocking Balloon (Second Balloon) 5 Second Blood Flow Blocking Balloon (3rd Balloon) 11 Blood Removal Catheter 12 Blood feeding catheter 13 First lumen 14 Second lumen 15 Third lumen 20 Aortic balloon catheter 40 Blood assisting circulator 50 Blood assisting circulation controller 55 Controller 58 Pumping means 51 Electrocardiograph 52 Aortic pressure Sensor 53 Flow rate sensor (blood flow sensor) 54 Motor driver 56 Switch panel 57 Indicator 59 Pressure generation pump (balloon inflation / deflation pump) 60 Pumping balloon drive control valve 61 First blood flow inhibition balloon drive control valve 62 Second blood flow obstruction balloon drive control valve 71 Blood donor For 72 constant pressure pump 73 pump motor 74 the blood removal catheter side blood tube 75 the blood removal catheter side blood tube 78 oxygenator

Front page continued (72) Inventor Atsuhiko Nogawa 1500 Inoguchi, Nakai-cho, Ashigarakami-gun, Kanagawa Terumo Corporation

Claims (5)

[Claims] 1. A balloon catheter for intra-aorta, a blood removal catheter to be inserted into a vena cava, and a balloon catheter for intra-aorta inserted so that the blood supply port is located downstream of the balloon in the aorta. A blood supply catheter, a blood supply means for supplying blood from the blood removal catheter side to the blood supply catheter side, and a blood auxiliary circulation device having an auxiliary circulation control device, wherein the intra-aortic balloon catheter comprises:
A catheter body, a pumping balloon provided near the distal end of the catheter body, a first blood flow obstruction balloon provided on the proximal side of the catheter body with respect to the pumping balloon, and the first blood A second blood flow blocking balloon provided on the proximal side of the catheter body with respect to the flow blocking balloon, and a first communicating with the pumping balloon.
Lumen, a second lumen that communicates with the first blood flow inhibiting balloon, and a third lumen that communicates with the second blood flow inhibiting balloon, and the controller includes the aorta. Combined auxiliary circulation for performing auxiliary circulation by an internal balloon catheter and auxiliary circulation by the blood supply means, auxiliary circulation selection function capable of selecting the aortic balloon catheter alone auxiliary circulation, and the auxiliary circulation by the blood supply means, It has a blood flow inhibition balloon control function, and the blood flow inhibition balloon control function is such that at the time of start of contraction of one blood flow inhibition balloon during the combined auxiliary circulation, the other blood flow inhibition balloon becomes inflated. Control function for combined circulation for controlling to inflate and deflate the two blood flow-inhibiting balloons alternately, and the aortic balloon catheter single auxiliary circulation Blood circulatory support apparatus characterized by having a possible balloon for the aorta to the catheter alone circulation time control functions pumping by the blood flow inhibitory balloon. 2. The blood assist according to claim 1, wherein the control device has a function of selecting the number of balloons to be operated from among the two blood flow inhibiting balloons when the balloon catheter for intra-aortic circulation is performed independently. Circulator. 3. The control device comprises a balloon located at a proximal end side when the balloon catheter for aorta is circulated alone,
The blood assisted circulation device according to claim 1 or 2, which has a balloon inflation sequence control function of initiating inflation by slightly shifting the inflation start time toward the distal balloon. 4. The first blood flow obstruction balloon and the second blood flow obstruction balloon have an inflated volume smaller than the inflated volume of the pumping balloon. The blood-assisted circulation device according to any one of 1. 5. The outer diameter of the first blood flow inhibiting balloon and the second blood flow inhibiting balloon when inflated is larger than the outer diameter of the pumping balloon when inflated. The blood assisted circulation device according to any one of 1 to 4.