JPH07265412A - Auxiliary circulating device for blood - Google Patents

Abstract

PURPOSE:To make it possible to execute efficient auxiliary circulation of blood, to make combination use of an IABP method and PCPS method in particular and in addition, 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 for the balloon catheter l. The balloon catheter 1 has a balloon 3 for pumping and a balloon 4 for blocking blood flow. The controller 50 controls the balloon 4 so as not to operate as a balloon for blocking blood flow unless both of the balloon 4 for pumping and the blood feed means 71 are in an operating state.

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 synchronism with the heartbeat, it has the effects of reducing the afterload (resistance during blood pumping), increasing the aortic diastolic pressure, and increasing the coronary blood flow. In addition, the PCPS method has effects of reducing preload (blood pressure returning to the heart) and maintaining (increasing) extracorporeal blood flow. However, there are some problems such as increased afterload and difficult management. On the contrary, in the IABP method, as described above, the blood circulation amount 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. For this reason, 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. And P
There is a high possibility that the advantages of the CPS method will be offset.

[0006] 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. The object of the present invention is to provide an intra-aortic balloon catheter and a blood assisted circulation device which maintain the above advantages and solve the above problems.

[0007]

The object of the present invention is to achieve the above object by providing a catheter body, a pumping balloon provided in the vicinity of the distal end portion of the catheter body, and a proximal side of the catheter body with respect to the pumping balloon. And an intra-aortic balloon having a blood flow blocking balloon having a volume smaller than that of the pumping balloon, a first lumen communicating with the pumping balloon, and a second lumen communicating with the blood flow blocking balloon. A catheter, a blood removal catheter inserted into the vena cava, and a blood delivery catheter inserted so that a blood delivery port is located downstream of the balloon of the intra-aortic balloon catheter in the aorta,
A blood assisting circulation device having a blood sending means for sending blood from the blood removal catheter side to the blood sending catheter side, and a control device for the intra-aortic balloon catheter, wherein the control device comprises the pumping balloon and the pumping balloon. It is a blood auxiliary circulation device that has a blood flow inhibition balloon control function for inflating the blood flow inhibition balloon in response to the operation of the blood means.

The blood flow inhibiting balloon preferably has an outer diameter when inflated that is larger than an outer diameter of the pumping balloon when inflated. What achieves the above-mentioned object is a balloon catheter for aorta,
A blood flow inhibiting member having an inflatable and defensible blood flow inhibiting balloon inserted downstream of the intra-aortic balloon catheter, a blood removal catheter inserted into the vena cava, and the blood flow inhibiting A blood-sending catheter inserted so that the blood-sending port is located downstream of the blood-flow-inhibiting balloon of the member in the aorta, and a blood-sending means for sending blood from the blood removal catheter side to the blood-sending catheter side, A blood auxiliary circulation control device comprising: a pumping balloon of the balloon catheter and an auxiliary circulation control device having a blood flow inhibition balloon control function for expanding the blood flow inhibition balloon in response to the operation of the blood supply means. . The blood flow inhibiting balloon preferably has a volume when inflated that is smaller than the volume of the pumping balloon when inflated. Furthermore, it is preferable that the outer diameter of the blood flow inhibiting balloon when inflated is larger than the outer diameter of the pumping balloon when inflated.

Therefore, the blood receiving and circulating apparatus of the present invention will be described with reference to the embodiment shown in the drawings. The aortic balloon catheter 1 used in the present invention includes a catheter body 2, a pumping balloon 3 (main balloon 3) that is a first balloon, and a blood flow inhibiting balloon 4 (sub balloon 4) that is a second balloon. , Hub 6, connecting tube 2
3 and 24.

More specifically, as shown in FIGS. 1 and 2, the aortic balloon catheter 1 of the embodiment has two balloons 3 and 4 on the outer circumference of the catheter body 2 as shown in FIG. In the catheter body 2,
It has a first lumen 13 that communicates only with the balloon 3 and a second lumen 14 that communicates only with the blood flow blocking balloon 4. Further, as shown in FIG. 2, the catheter body 2 has a third lumen 16 at its center for inserting a guide wire when inserting the catheter 1 into a blood vessel and for measuring aortic pressure. There is. And the 1st lumen 13 and the 2nd lumen 14 are catheter side connection tubes 23 and 24 connected to the hub 6, respectively.
Is in communication with. Further, the connecting tubes 23 and 24 are respectively connected to a connecting connector 2 for connecting with a connecting tube of the balloon catheter control device for the aorta which will be described later.
7, 28 are provided.

The catheter body 2 preferably has 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 and the blood flow blocking balloon 4 can be inflated and deflated, and these balloons 3 and 4 are in a state of being in close contact with or folded over the outer circumference of the catheter body when deflated. It is configured to be able to. As the material of the balloons 3 and 4, those having a certain degree of plasticity and a hardness capable of sending blood are preferable, and examples thereof include polyolefins such as polyethylene, polypropylene and ethylene-propylene copolymer, polyesters such as polyethylene terephthalate,
Polyvinyl chloride, ethylene-vinyl acetate copolymer, cross-linking type ethylene-vinyl acetate copolymer, thermoplastic resin such as polyurethane, polyamide elastomer, silicone rubber, latex rubber and the like can be used. Balloons 3 and 4
Are both ends on the outer peripheral surface of the catheter body 2,
For example, they are fixed by adhesion (for example, heat fusion). In addition, inside the balloons 3 and 4, the catheter body 2
Through the openings 33, 34 provided on the outer surface of the lumen 1,
The inflation fluid can flow into the balloons 3 and 4 in communication with the balloons 3 and 14, respectively.

As for the volumes of the balloons 3 and 4, in the embodiment shown in FIG. 1, the pumping balloon 3 is larger and the blood flow inhibiting balloon 4 is smaller than the pumping balloon. By doing so, it is easy to send and discharge the driving fluid when the inhibition balloon is inflated and deflated,
The lumen 14 communicating with the inhibition balloon 4 can be made thin, and an increase in the outer diameter of the catheter can be suppressed 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 can be reduced and branch blood vessel occlusion can be suppressed. As described above, when the volume of the pumping balloon is increased, it is preferable that the volume of the pumping balloon: the volume of one blood flow inhibiting balloon = 2 to 20: 1, and more preferably 5 to 20: 1.
And particularly preferably 10 to 20: 1.

Specifically, as the size of the balloons 3 and 4, the outer diameter of the cylindrical portion when inflated is 12 to 17 m.
m, 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. Further, the total volume of the balloon is preferably 20 to 40 ml. Also,
For children, the size of the balloons 3 and 4 is
The outer diameter of the cylindrical portion when expanded is 4 to 12 mm, preferably 4 to 10 mm. The length of the main balloon is 60 to 200 mm, and the length of the inhibition balloon is 3 mm.
Approximately 50 mm is suitable. The total volume of the balloon is preferably 1 to 10 ml. Further, the blood flow inhibiting balloon 4 is 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. That is, since this catheter has the blood flow inhibiting balloon, the blood flow inhibiting balloon substantially divides the blood circulation path into two upstream and downstream blood circulation paths. Therefore, as will be described later, it is possible to prevent the auxiliary circulation blood flow due to IABP and the auxiliary circulation blood flow due to PCPS from colliding with each other.

Further, the blood flow inhibiting balloon 4 may be such that it is in close contact with the inner wall of the blood vessel when it is inflated 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. It is also possible to reliably prevent the flow of blood due to the operation of the pumping balloon to the proximal end side of the blood supply catheter. However, it is preferable that it is slightly smaller than the inner diameter of the blood vessel in the vicinity where the blood flow blocking balloon of the patient to be used is located. By doing so, the amount of blood that circulates from the outer circumference of the blood flow inhibiting balloon is extremely small and does not adhere to the blood vessel, so that the inner wall of the blood vessel is not burdened.
The outer diameter of the pumping balloon when inflated varies depending on the size of the patient to be used and is not uniform, but it is preferably larger than the outer diameter of the pumping balloon by about 1 to 5 mm.

Next, the blood assisting circulation device 40 of the first embodiment shown in FIG. 3 will be described. As shown in FIG. 3, this blood assisting circulation device includes an intra-aortic balloon catheter 1 and a blood removal catheter 1 to be inserted into a vena cava.
1, a blood supply catheter 12 inserted so that the blood supply port 16 is located downstream of the blood flow blocking balloon 4 of the intra-aortic balloon catheter 1 in the aorta, and a blood supply catheter from the blood removal catheter 11 side It has a blood supply means 71 for supplying blood to the 12th side, an artificial lung 78, and a control device 50 for an intra-aortic balloon catheter. Then, as shown in FIG. 7, which will be described later, the blood flow morphology of the patient is divided before and after the blood flow inhibiting balloon 4 of the intra-aortic balloon catheter 1, and the upstream side is an upper limb assisted by the pumping balloon. The downstream side is divided into the lateral body blood circulation path and the lower limb side body blood circulation path which is assisted and circulated by the blood sending means. That is, the upper limb side is assisted by the IABP method, and the lower limb side is assisted by the PCPS method including a blood sending catheter, a blood removal catheter, a blood sending means, and an artificial lung.

As the blood feeding means 71 used in the blood supplementary circulation device 40 of this embodiment, 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. It comprises a constant pressure pump means, 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 FIG. 1, the blood sending means 71 is composed of a centrifugal pump 72 and a motor 73 for driving this centrifugal 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 rear end 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 front 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 either 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 and the like, by covalently bonding to the hydrophilic resin. Can be fixed.

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 has a pump means 58 capable of independently circulating the fluid through the two lumens 13 and 14.
And at least a controller 55 of the pump means 58. Further, the controller 55 operates the blood flow inhibiting balloon as a blood flow inhibiting balloon in response to the operation of the pumping balloon and the blood feeding means. It has a flow control balloon control function. In other words, the controller 55 does not operate the blood flow blocking balloon 4 at least when both the pumping balloon and the blood-sending means are in operation (a state in which both IABP-assisted circulation and PCPS-assisted circulation are performed). It has a function of controlling so as not to operate as a blood flow blocking balloon. Then, at the time of use, the control device 50 includes an electrocardiograph 51, an aortic pressure sensor 52, a flow rate sensor 53 (a blood flow sensor 53, a blood tube 74 or 7).
5 attached). All of these may be considered as a control device.

Since the controller 55 has the above-mentioned blood flow inhibition balloon control function, for example, when the auxiliary circulation by this device is only the pumping balloon, and conversely when it is only PCPS, the blood flow is increased. The blocking balloon will not operate as a blood flow blocking balloon. This function is used when, while performing both IABP-assisted circulation and PCPS-assisted circulation, any of the assisted circulation is stopped due to some cause (for example, a sudden change in the patient's condition or a defective device). It is also effective. 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. If the blood flow blocking balloon is constantly inflated during the auxiliary circulation of PCPS alone, the blood flow pumped by the heart from the upstream side of the blood flow blocking balloon is substantially blocked. Is
At the same time, the flow of blood flow by PCPS upstream of the blood flow blocking balloon is also blocked.

The control device 50 has various functions in addition to the above-mentioned control function of the blood flow inhibiting balloon.
It is a blood-assisted circulation control device. Specifically, the control device 50 uses the combined auxiliary circulation (IA) for performing the auxiliary circulation by the intra-aortic balloon catheter and the auxiliary circulation by the blood supply means.
BP / PCPS combined mode), aortic balloon catheter single auxiliary circulation (IABP single mode), and blood supply means single auxiliary circulation (PCPS single mode), and an auxiliary circulation selection function (mode selection function), Has a balloon control function for blood flow inhibition. The blood flow inhibiting balloon control function has a control function for intra-aortic balloon catheter single circulation that enables pumping by the blood flow inhibiting balloon during intra-aortic balloon catheter single auxiliary circulation. Furthermore, the control device has a balloon inflation sequence control function that starts 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. There is.

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. That is, the blood flow inhibiting balloon 4 should not be operated as a blood flow inhibiting balloon except during 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 supply means are performed. It has a control function. Further, the control device has a function of confirming recovery of cardiac function. This cardiac function recovery function is activated by turning off the PCPS start switch. 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. If 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 reactivated.

Specifically, this control device 50
As shown in FIGS. 3 and 4, the controller 55, the switch panel 56, the display 57, the pressure generating pump (balloon inflation / deflation pump) 59, the pumping balloon drive control valve 60, and the blood flow obstruction balloon. It has a drive control valve 61 and a motor driver 54. Pressure generation pump (balloon inflation / deflation pump) 59, pumping balloon drive control valve 60, blood flow inhibition balloon drive control valve 61
The pump means 58 is constituted by the above. Further, the control valve 60 includes a first catheter connecting tube 63.
However, a second catheter connecting tube 64 is connected to the control valve 61, and these tubes are connected to connectors 66 and 6 for connecting to the connectors 27 and 28 of the catheter.
7 is attached.

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. Therefore, if the aortic pressure is increased when the aortic valve is closed, blood can be reliably sent to the coronary arteries. 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.

As for the deflation timing of the balloon, an average value is calculated from a predetermined number (for example, the most recent 5 times) of R wave generation timings and intervals, and the R wave generation cycle is constantly calculated. And a pseudo P wave (opening signal) generation timing, a pseudo P wave which is appropriately delayed from the pseudo T wave is calculated, and the pseudo P wave is calculated by using the control valve 60 so that the balloon deflation start signal (the inside of the balloon becomes a negative pressure state). It is configured to output as an operation signal). That is, this occlusion signal is output almost in synchronization with the opening of the aortic valve. Also,
The inflation of the pumping balloon 3 need not be performed in the same number as the heart rate, and for example, the pseudo T-wave signal is transmitted several times, for example,
You may make it inflate once every 1 to 8 times input.

The controller 55 preferably has an auxiliary circulation selection function in addition to the above-mentioned blood flow inhibition balloon control function. The auxiliary circulation selection function is, for example, a full mode (IABP / PCPS combined mode) in which both IABP and PCPS as described above are performed, and IABP-only I
It is preferable to have a function of arbitrarily selecting the ABP single mode or the PCPS only PCPS single mode. If it has such a function, this control device can operate as IABP, P
It can also be used for auxiliary circulation by CPS alone. In the embodiment shown in the flow chart described later, the combined mode switch is turned on, and the IABP start switch and the PC are connected.
When both PS start switches are turned on, the combined mode is set.

Further, when the blood assisting 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), the controller 55 activates the blood flow inhibiting balloon. Inflates and deflates in synchronization with the pumping balloon to create the second IAB
It has a function of operating as a P balloon. If the blood flow inhibiting balloon can also be operated as an IABP balloon in this way, the assisting effect of IABP becomes large.

Further, in this case, it is preferable that the controller 55 has a balloon inflation sequence control function for controlling the pump 59 and the control valves 60 and 61 as follows. When performing balloon pumping using the balloons 3 and 4 (double balloon mode), the controller 55 starts to inflate the blood flow inhibiting balloon 4 on the proximal end side, and The inflation order of the balloons is controlled so that the pumping balloon 3 begins to inflate slightly later than the start of inflation. When balloon pumping is performed using a plurality of balloons, the controller 55 controls to start inflation from the proximal balloon as described above, so that the blood flow can be reliably sent to the heart side. It is possible and pressure does not escape to the peripheral side.

As a concrete method of the balloon inflation start timing, as described above, the balloon to be inflated first by the inflation start signal (pseudo T wave signal) calculated from the electrocardiogram waveform (the balloon for blood flow inhibition) 4) is inflated, that is, the pseudo T-wave signal is used as the inflation start signal of the proximal side balloon (blood flow blocking balloon), and the pseudo T-wave signal is delayed by, for example, 10 to 200 ms. Is sent to start the inflation of the balloon (pumping balloon) on the tip side. Then, when these expansion start signals are input to the control valves 60 and 61, the air supplied from the pump 59 flows into the balloon so that the inside of the balloon has a positive pressure. Two solenoid valves are activated.

Then, the controller 55, as described above,
The balloons 3 and 4 are operated to be deflated by the deflation start signal (pseudo P wave signal) calculated from the electrocardiogram waveform. Similarly to the inflation start signal, the deflation start signal may be output with a time difference for each balloon. In this case, first, the deflation of the main balloon 3 is started, and subsequently, the first inhibition balloon 4 and the second inhibition balloon 5 are controlled to deflate.
By doing so, the afterload reduction effect at the time of cardiac output is increased. When these contraction start signals are input to the control valves 60 and 61, the pump 59 discharges the gas flowing into the balloon, and the inside of the control valves 60 and 61 is provided so that the inside becomes negative pressure. The two solenoid valves that operate are activated. As the control valves 60 and 61, those having two electromagnetic valves inside and capable of switching the pressure from the pressure generating pump to positive pressure and negative pressure by operating the two electromagnetic valves are 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 or a vacuum pump can be used. The display 57 includes a pumping balloon operating pressure display unit, a blood flow blocking balloon operating pressure display unit, a flow rate display unit detected by a flow rate sensor, an aortic pressure display unit detected by an aortic pressure sensor, and an auxiliary circulation by PCPS. A quantity display unit and the like are provided.

The switch panel 56 has a power switch, an IABP / PCPS combined mode switch (a switch for selecting the combined mode), an IABP single mode switch (a switch for selecting the IABP single mode), a PCPS single mode. Switch (switch for selecting PCPS single mode), double balloon switch (switch for selecting blood balloon assistance by operating the blood flow blocking balloon as a pumping balloon in IABP single mode) , I
ABP start switch, PCPS start switch,
A PCPS flow rate input switch, a pumping balloon inflation pressure input switch, a blood flow inhibition balloon inflation pressure input switch, and the like are provided. Further, the control device 55
It has an alarm 69 that sounds when an abnormality occurs. This alarm is, for example, an abnormality in the electrocardiogram waveform input from the electrocardiograph 51 by the controller 55, a change in the flow rate detected by the flow rate sensor beyond the allowable range (for example, a sharp decrease),
A change in the aortic pressure detected by the aortic pressure sensor that exceeds the allowable range (for example, a sudden decrease), a controller, a pump,
Sounds when an abnormality is detected in the control valve or driver.

Next, the second blood auxiliary circulation device 7 of the present invention
0 will be described. Blood assisting circulation device 7 of this embodiment
As shown in FIG. 5, 0 is a balloon catheter for intra-aortic catheter 1, a blood removal catheter 11 to be inserted into the vena cava,
Blood delivery catheter 12 inserted so that blood delivery port 16 is located downstream of balloon 3 of balloon catheter 1 for aorta in the aorta, and blood delivery from blood removal catheter 11 side to blood delivery catheter 12 side A blood flow blocking member 3 having a blood flow means 71 for controlling the blood flow, and a blood flow blocking balloon 4 capable of expanding and contracting located between the balloon 3 of the intra-aortic balloon catheter 1 and the blood supply port 16 of the blood supply catheter 12.
0, the balloon 3 and the balloon 4 of the blood flow blocking member 30
It has a control device 50 having the control function of.

This blood auxiliary circulation device 70 and the above-mentioned first
The difference from the blood auxiliary circulation device 40 is the difference in the intra-aortic balloon catheter. The balloon catheter 1 used in the device shown in FIG.
It also had a blood flow inhibiting balloon 4. But,
As the aortic balloon catheter 20 used in the apparatus of this embodiment, as shown in FIG. 5, a balloon catheter having only the pumping balloon 3 is used. The blood flow inhibiting member 30 including the balloon 4 is used. The intra-aortic balloon catheter 20 is composed of a catheter body 2, a pumping balloon 3, a lumen 13 communicating with the balloon 3, and a hub 6. Then, the hub 6 functions as a connection connector for connecting to the intra-aortic balloon catheter control device-side connection tube 63.

The catheter body 2 is preferably one having a certain degree of flexibility, for example, a polyolefin (eg, polyethylene, polypropylene, ethylene-
Propylene copolymers, ethylene-vinyl acetate copolymers, etc.), polyvinyl chloride, polyamide elastomers, thermoplastic resins such as polyurethane, polyimide, silicone rubber, latex rubber, etc. can be used, preferably the above-mentioned thermoplastic resins. , And more preferably polyurethane. The length of the catheter body 2 is 200-60
0 mm, more preferably 200-550 mm, outer diameter 1.0-5.0 mm, more preferably 2.0-
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 of the catheter body 2 functions as a guiding portion for the catheter 20, and the catheter 2
A zero tip 10 is provided to prevent damage to the vessel wall during insertion into the 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, a metal member formed of Pt, Pt alloy, W, W alloy, Ag, Ag alloy or the like may be embedded or metal powder may be mixed inside the tip portion.

The pumping balloon 3 can be inflated and deflated, and when the balloon 3 is deflated, it can be brought into close contact with or folded over the outer periphery of the catheter body. The material of the balloon 3 is preferably one having a certain degree of plasticity and hardness enough to deliver blood, such as 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.

Both ends of the balloon 3 are the catheter main body 2
It is fixed to the outer peripheral surface of, for example, by adhesion. Further, the inside of the balloon 3 communicates with the lumen 13 through the opening 33 provided on the outer surface of the catheter body 2, and the inflation fluid can flow into the inside of the balloon 3. Further, the catheter body 2 has a lumen (not shown) at its center for inserting a guide wire when inserting the catheter 20 into a blood vessel. Regarding the size of the balloon 3, the outer diameter of the cylindrical portion when inflated is 12 to 17 mm, preferably 15 to 16 mm. The length of the balloon 3 is 180 to 300 m.
m, and the volume of the balloon is preferably 20 to 40 ml. In the case of children, the balloon 3 has a size such that the outer diameter of the cylindrical portion when inflated is 4 to 12 m.
m, preferably 4 to 10 mm. Also, balloon 3
Has a length of 60 to 200 mm, and the balloon has a volume of 1 to
10 ml is preferred.

The blood flow inhibiting member 30 includes the inhibiting member main body 32.
And blood flow blocking balloon 4, hub 36, connecting tube 2
4 and. More specifically, the blood flow inhibiting member 30 includes the balloon 4 on the outer periphery of the inhibiting member main body 32.
The obstruction member main body 32 has the first lumen 14 communicating with the blood flow obstruction balloon 4 therein. Furthermore, the inhibition member main body 32 may have a third lumen (not shown) for inserting a guide wire when inserting the inhibition member 30 into the blood vessel at the center thereof. The hub 36 functions as a connecting connector for connecting to an intra-aortic balloon catheter control device-side connecting tube described later.

As the inhibiting member main body 32, one having a certain degree of flexibility is preferable, and for example, a polyolefin (eg, polyethylene, polypropylene, ethylene-
Propylene copolymer, ethylene-vinyl acetate copolymer, etc.), polyvinyl chloride, polyamide elastomer, thermoplastic resin such as polyurethane, polyamide elastomer,
Silicon rubber, latex rubber or the like can be used, preferably the above-mentioned thermoplastic resin, and more preferably polyolefin. The length of the inhibition member 30 is 50 to
500 mm, more preferably 100-450 mm, outer diameter 1.0-5.0 mm, more preferably 2.0-
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 of the inhibiting member main body 32 functions as a guiding portion of the inhibiting member 30 and prevents the distal end portion 31 of the inhibiting member 30 from damaging the blood vessel wall during insertion into the blood vessel. It is provided in. For this reason, the tip portion 31 of the inhibiting member main body 32 is formed into a curved surface that is in the shape of a shell or a hemisphere. 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 blood flow inhibiting balloon 4 can be inflated and deflated, and when the balloon 4 is deflated, the balloon 4 can be brought into close contact with the outer periphery of the inhibition member main body 32 or folded. ing. The material of the balloon 4 is preferably one having a certain degree of plasticity and hardness enough to deliver blood, such as 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. Both ends of the balloon 4 are fixed to the outer peripheral surface of the inhibition member main body 32, for example, by adhesion (for example, heat fusion). Further, the inside of the balloon 4 communicates with the lumen 14 through the opening 34 provided on the outer surface of the inhibition member main body 32, and the inflation fluid can flow into the inside of the balloon 4.

The size of the blood flow inhibiting balloon 4 varies depending on the physique of the patient to be used and is not uniform,
About 8 to 75 mm is preferable, and the outer diameter when expanded is 13
-22 mm is preferable, and 15-20 mm is particularly preferable. For children, the length of the balloons 4 and 5 is preferably about 3 to 50 mm, and the outer diameter when inflated is
4 to 12 mm is preferable, and 4 to 10 is particularly preferable.

In the embodiment shown in FIG. 5, the pumping balloon 3 has a larger volume, and the blood flow inhibiting balloon 4 has a smaller volume than the pumping balloon. By doing so, the contact area between the inhibiting balloon and the blood vessel can be reduced, so that stress on the blood vessel is reduced and branch blood vessel occlusion can be suppressed. In this way, when the volume of the pumping balloon is increased, the pumping balloon volume: the blood flow inhibition balloon 1
One volume = 2 to 20: 1 is preferable, more preferably 5 to 20: 1, and particularly 10 to 2
0: 1 is preferred.

Further, the blood flow inhibiting balloon 4 is 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, it is possible to reliably prevent the blood from the blood supply catheter side described later from flowing to the distal end side of the balloon catheter, and to operate the pumping balloon. It is also possible to reliably prevent the blood from flowing to the proximal end side of the blood supply catheter. That is, since this catheter has the blood flow inhibiting balloon, the blood flow inhibiting balloon can substantially divide the blood circulation path into two upstream and downstream blood circulation paths. Therefore, as will be described later, the IA
It is possible to prevent the auxiliary circulation blood flow due to BP and the auxiliary circulation blood flow due to PCPS from colliding with each other.

Further, the blood flow inhibiting balloon may be one that can be in close contact with the inner wall of the blood vessel when inflated to occlude 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. However, it is preferable that it is slightly smaller than the inner diameter of the blood vessel in the vicinity where the blood flow blocking balloon of the patient to be used is located. By doing so, the amount of blood that circulates from the outer circumference of the blood flow inhibiting balloon is extremely small and does not adhere to the blood vessel, so that the inner wall of the blood vessel is not burdened. The outer diameter of the pumping balloon when inflated varies depending on the size of the patient to be used and is not uniform, but it is preferably larger than the outer diameter of the pumping balloon by about 1 to 5 mm.

Further, the blood auxiliary circulation device 70 of the present invention
It is preferable that blood can be circulated without using an anticoagulant as in the case of the blood auxiliary circulation device 40 described above. To this end, the blood contact surface in the blood-assisted circulation circuit, in particular the artificial lung 78, the blood tubes 74, 75, the blood delivery catheter 11,
Blood removal catheter 12, aortic balloon catheter 2
0, it is preferable to fix an antithrombotic material on the blood contact surface of the blood flow inhibiting member 30. Others are the same as those of the blood assisting circulation device 40 of the above-described embodiment.

[0057]

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 the blood outlet is left at a position on the downstream side of the blood flow inhibiting balloon 4 of the intra-aortic balloon catheter 1. And
Replace the catheters 11 and 12 with tubes 74 and 75
Connect to. 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, the 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) based on the electrocardiogram waveform.
And the contraction start signal (pseudo P wave signal) is calculated. Further, the display 57 displays the data detected by the aortic internal pressure sensor 52 and the flow sensor 53.

Then, as shown in the flow chart of FIG. 8, 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.

Then, 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. Then, in this way, the pumping balloon (I
The blood flow by the ABP) and the blood flow by the pump (PCPS) are separated by the blood flow blocking balloon, and the blood flows of the both do not substantially collide or mix. Therefore, the effects of reducing the afterload (resistance at the time of pumping blood), increasing the aortic pressure and increasing the coronary blood flow by the IABP method are retained, and further by the PCPS method,
The effects of reducing the preload (blood pressure returning to the heart) and maintaining (increasing) the extracorporeal circulation blood flow can be maintained, and blood assist circulation with the advantages of both can be performed.

By the operation of the centrifugal pump 72, blood is sent to the centrifugal pump 72 and the artificial lung 78 through the blood removal side tube 74, and the artificial lung 78 removes oxygen and carbon dioxide from the blood. After the operation, the balloon 5 (the second proximal end) of the intra-aortic balloon catheter 1 is passed through the blood sending tube 75 and the blood sending 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 of the upper limbs is lowered due to the low pumping ability, which indicates that it is not the 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 decreases, the PCPS start switch is automatically turned on, the centrifugal pump drive motor operates, and the inhibition balloon also restarts.

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 double balloon switch is automatically turned on as shown in A of FIG. The flow inhibition balloon 4 starts to operate as a pumping balloon, and the balloon 3 continues to operate. When the double balloon switch is turned off, only the blood flow inhibiting balloon 4 is deactivated. 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.
Reduce to. In addition, when the above switch is turned on or off, the cardiac function recovery confirmation function is activated in each mode in the same manner as above, and the aortic pressure is confirmed. If there is no change (when it is recovered), select The selected mode is continued. 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 this case, 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.

Further, when the combined mode switch in FIG. 8 is not turned on, the flow shifts to that in FIG. 10, and when the IABP single mode switch is turned on, the IABP single mode is shifted. Also in this case, as shown in the flowchart of FIG. 10, it is determined whether or not the inflation pressure of the pumping balloon is changed, and if there is a change in the set pressure, the controller 55 stores and displays the input set pressure. It is displayed on the device 57, and it is determined whether the inflation pressure of the blood flow blocking balloon is changed. If there is a change in the set pressure, the input set pressure is input to the controller 5
5 is stored and displayed on the display 57. Then, when the double balloon switch is turned on, the mode is changed to a double balloon IABP mode (a mode in which pumping is performed using two balloons, a balloon for pumping and a balloon for blood flow inhibition), and when the IABP start switch is turned on, The pump operates, and the pumping balloon (main balloon) and the blood flow inhibition balloon 4 (sub balloon 4) start pumping operation (expansion / contraction).
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 it is considered that the blood flow inhibiting balloon should be stopped (reduction of the auxiliary circulating blood volume) due to the recovery of the patient, the double balloon switch is turned off. 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, it returns to the double balloon IABP mode. When the cardiac function recovery confirmation is performed, the operation of the blood flow inhibiting balloon 4 is stopped,
Switch to single balloon mode. Then, as shown in FIG. 11, 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. Reduce to. 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 pumping balloon is stopped, the blood flow assisting work is completed, and the balloon catheter 1 and the blood removal catheter 1 from the patient are stopped.
1. The blood supply catheter 12 is removed to complete the procedure.

When the IABP start switch is turned on without turning on the double balloon switch, the process shifts from that shown in FIG. 10 to that shown in FIG.
The ABP mode (a mode in which only the pumping balloon is pumped) is entered, the pump operates, and the pumping balloon (main balloon) starts pumping operation (inflation / deflation). 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 condition of the patient, the double balloon switch is turned on. Then, as shown in FIG. 12, when the double balloon switch is turned on, the double balloon mode is entered, and when the actuation frequency control switch is turned on, the actuation frequency control mode is entered.

Also, the combined mode switch and IABP
When the PCPS single mode switch is turned on without the single mode switch being turned on, 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 changed to the combined mode as shown in FIG. When the IABP single mode switch is turned on, the motor stops and the mode shifts to the IABP single mode as shown in FIG. 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. Remove 12 to end the procedure.

[0066]

The first blood assisting circulation device of the present invention is provided with a catheter body, a pumping balloon provided near the distal end of the catheter body, and a proximal end side of the catheter body with respect to the pumping balloon. And a blood flow blocking balloon having a volume smaller than that of the pumping balloon, a first lumen communicating with the pumping balloon, and a second lumen communicating with the blood flow blocking balloon, as an intra-aortic catheter. A blood removal catheter to be inserted into the vena cava, a blood delivery catheter to be inserted so that a blood delivery port is located downstream of the balloon of the intra-aortic balloon catheter in the aorta, and a blood delivery catheter to be delivered from the blood removal catheter side. A blood assisting circulation device having a blood supply means for supplying blood to the blood catheter side and a control device for the aortic balloon catheter. The controller, in response to actuation of the pumping balloon and the blood feed means and a blood flow inhibition balloon control function inflating the blood flow inhibition balloon. That is a blood-assisted circulation device. Also,
A second blood assisting circulation device of the present invention comprises a balloon catheter for intra-aorta, and a blood flow blocker having an inflatable and defensible blood flow blocking balloon inserted downstream of the intra-aortic balloon catheter in the aorta. A member, a blood removal catheter inserted into the vena cava, a blood supply catheter inserted so that the blood supply port is located downstream of the blood flow blocking balloon of the blood flow blocking member in the aorta, and Blood sending means for sending blood from the blood catheter side to the blood sending catheter side, and a blood flow inhibiting balloon control function for inflating the blood flow inhibiting balloon in response to the operation of the pumping balloon and the blood sending means And an auxiliary circulation control device having.

Therefore, in these blood assisting circulation devices,
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 blood flows may collide.
There is virtually no mixing. 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. Fluid pressure)
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, the control device operates as a blood flow inhibiting balloon unless both the pumping balloon and the blood-sending means operate at least by the above function (a state in which both IABP-assisted circulation and PCPS-assisted circulation are performed). IAB is controlled so that it does not
During assisted circulation using only P and PCPS, the blood flow inhibiting balloon does not operate as a blood flow inhibiting balloon. Therefore, during IABP and PCPS alone assisted circulation, the blood flow inhibition balloon does not interfere with the assisted circulation blood flow and is safe. Furthermore, since the blood pressure on the upper limb side directly reflects the function of the heart, it can be used as an index for recovery of cardiac function. In other words, without a blocking balloon, even if the blood flow is good, it is not possible to determine whether it is due to the recovery of cardiac function or the PCPS blood flow. However, in the device of the present invention, recovery of cardiac function can be confirmed by the blood pressure on the upper limb side. Further, if the aorta is occluded by a blocking balloon, baroreflex of body blood vessels occurs, and peripheral vascular resistance decreases, so that the effect of reducing the afterload of the heart becomes greater.

[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 a schematic view of a blood assisting circulation device according to another embodiment of the present invention.

FIG. 6 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. 7 is an explanatory diagram 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.

FIG. 13 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 body 3 balloon for pumping (main balloon) 4 balloon for blood flow inhibition (sub balloon) 11 blood removal catheter 12 blood supply catheter 13 first lumen 14 second lumen 20 balloon for aorta Catheter 40 Blood assisted circulation device 50 Blood assisted circulation control device 55 Controller 58 Pump 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) Contraction pump) 60 Pumping balloon drive control valve 61 Blood flow obstruction balloon drive control valve 71 Blood sending means 72 Constant pressure pump 73 Pump motor 74 Blood removal catheter side blood tube 75 Blood removal catheter side blood tube 78 people Engineering lung

Claims (5)

[Claims] 1. A catheter body, a pumping balloon provided in the vicinity of the distal end portion of the catheter body, and a blood flow provided at a proximal end side of the catheter body with respect to the pumping balloon and having a volume smaller than that of the pumping balloon. An intra-aortic balloon catheter having a blocking balloon, a first lumen communicating with the pumping balloon, and a second lumen communicating with the blood flow blocking balloon, and blood removal inserted into the vena cava A catheter, a blood supply catheter that is inserted so that a blood supply port is located downstream of the balloon of the intra-aortic balloon catheter, and a blood supply catheter that supplies blood from the blood removal catheter side to the blood supply catheter side. A blood auxiliary circulation device having a blood means and a control device for the aortic balloon catheter,
The blood auxiliary circulation device, wherein the control device has a blood flow inhibition balloon control function for inflating the blood flow inhibition balloon in response to the operation of the pumping balloon and the blood supply means. 2. The blood auxiliary circulation device according to claim 1, wherein the blood flow inhibiting balloon has an outer diameter when inflated that is larger than an outer diameter when the pumping balloon is inflated. 3. A blood flow inhibiting member having an intra-aortic balloon catheter, an inflatable and defensible blood flow-inhibiting balloon inserted downstream of the intra-aortic balloon catheter in the aorta, and in a vena cava. Blood removal catheter to be inserted, blood delivery catheter to be inserted so that the blood delivery port is located downstream of the blood flow inhibiting balloon of the blood flow inhibiting member in the aorta, and blood delivery catheter from the blood removal catheter side Blood supply means for supplying blood to the side, and auxiliary circulation having a blood flow inhibition balloon control function for inflating the blood flow inhibition balloon in response to the operation of the pumping balloon and the blood delivery means of the balloon catheter. A blood auxiliary circulation device comprising a control device. 4. The blood assisted circulation apparatus according to claim 3, wherein the blood flow inhibiting balloon has a volume when inflated that is smaller than a volume of the pumping balloon when inflated. 5. The blood auxiliary circulation device according to claim 3, wherein the blood flow inhibiting balloon has an outer diameter when inflated that is larger than an outer diameter when the pumping balloon is inflated.