Extracorporeal circulation device

Abstract

[Problem] To provide an extracorporeal circulation device for which suitable timing for withdrawal can be determined with high accuracy. [Solution] This extracorporeal circulation device 1 allows blood to circulate extracorporeally using a circulation circuit 1R wherein the extracorporeal circulation device 1 is provided with: a blood removal side catheter 5, one section of which is inserted into a patient P, that guides blood taken out of the patient P; a pump 3 that takes the blood out of the patient P and returns the blood to the patient P; a blood feed side catheter 6 that is disposed downstream of the pump 3 and one section of which is inserted into the patient and guides the blood fed from the pump 3 to the patient P; a pump rotational rate detection unit 36 that detects the rotational rate of the pump 3; and a control system 10 that comprises at least an extracorporeal circulation management system that determines the stability of the state of extracorporeal circulation or a cardiac function measurement system that determines the stability of the cardiac function of the patient P.

Description

Technical Field

[0001] The present invention relates to an extracorporeal circulation device.

Background Art

[0002] One of the specialized resuscitation treatments for patients with cardiac arrest is invasive cardiopulmonary resuscitation (Percutaneous Cardiopulmonary Support: PCPS) using an extracorporeal circulation device as a percutaneous cardiopulmonary support device. Such resuscitation treatment is sometimes called extracorporeal cardiopulmonary resuscitation (ECPR) or ECMO (Extracorporeal Membrane Oxygenation ).

[0003] In invasive cardiopulmonary resuscitation using an extracorporeal circulation device, determining the timing suitable for the detachment of the extracorporeal circulation device is one of the important factors. That is, if the timing of the detachment of the extracorporeal circulation device is too early, the patient's heart may not be able to withstand it, and the need to reinstall the extracorporeal circulation device may occur, or the patient may die. On the other hand, if the timing of the detachment of the extracorporeal circulation device is too late, complications such as bleeding may occur due to the consumption of anticoagulant therapy and plasma components. That is, there is an appropriate timing for the detachment of the extracorporeal circulation device. And it is desirable to be able to determine the timing suitable for the detachment of the extracorporeal circulation device at an early stage.

[0004] As a criterion for determining the timing suitable for the detachment of the extracorporeal circulation device, for example, the stability of the patient's cardiac function, in other words, the degree of recovery of the patient's cardiac function, can be mentioned. However, it is difficult to accurately determine the recovery of the patient's cardiac function.

[0005] That is, during invasive cardiopulmonary resuscitation using an extracorporeal circulation device, the pump of the extracorporeal circulation device withdraws blood from the patient, passes it through an artificial lung, and returns the blood that has passed through the artificial lung to the patient. At this time, the direction of the flow of the blood returned to the patient's body by the pump is opposite to the direction of the flow of the blood flowing in the patient's body. That is, the pump returns the blood that has passed through the artificial lung to the patient in a state having retrograde flow. Therefore, even when a flow sensor attached to a catheter is delivered near the patient's heart, it is difficult to measure only the cardiac output of the heart. Therefore, in this case, it is difficult to accurately determine the recovery of the patient's cardiac function.

[0006] In addition, there are also facilities that once stop the operation of the extracorporeal circulation device to measure the cardiac output of the heart in order to determine the recovery of cardiac function. However, in order to reduce the burden on the patient, it is desirable to be able to continuously determine the recovery of cardiac function rather than intermittently.

[0007] Patent Document 1 discloses a cardiac function evaluation device that calculates the time derivative of the blood flow measured by a blood flow meter and evaluates the cardiac function based on the calculation result. The cardiac function evaluation device described in Patent Document 1 converts the time derivative of the blood flow into the time derivative of the blood pressure. The relationship between the time derivative of the blood flow and the time derivative of the blood pressure is described in FIG. 2 of Patent Document 1. According to FIG. 2 described in Patent Document 1, although a cardiac function evaluation block including a blood flow meter is provided near the patient's heart, the error of the time derivative of the blood pressure is relatively large. Therefore, as described above, even when a blood flow meter is provided near the patient's heart, it is difficult to accurately determine the recovery of the patient's cardiac function.

[0008] In addition, as another criterion for determining the timing suitable for the removal of the extracorporeal circulation device, for example, the stability of the dynamics of blood circulation in the circulation circuit of the extracorporeal circulation device, that is, the stability of the dynamics of extracorporeal circulation can be mentioned. However, the stability of the dynamics of extracorporeal circulation is often determined based on the experience and knowledge of medical staff, and it is difficult to accurately determine the stability of the dynamics of extracorporeal circulation.

[0009] That is, as one of the factors causing a decrease in the stability of the extracorporeal circulation dynamics, for example, poor blood drainage due to the tip of the venous cannula (blood drainage side cannula) adhering to the blood vessel wall can be cited. When poor blood drainage occurs, medical staff administer, for example, physiological saline to the vein or perform blood transfusion based on experience and knowledge. However, since replenishment of fluids such as physiological saline and blood transfusion are not methods for eliminating the root cause of poor blood drainage, there is a risk of recurrence of poor blood drainage. Also, considering that there is a risk that fluids such as physiological saline may leak outside the blood vessel and cause edema, it is desirable to limit the amount of fluids such as physiological saline to be replenished and the amount of blood transfusion.

[0010] Thus, for example, it is desired that by accurately determining the stability of the patient's cardiac function or the stability of the extracorporeal circulation dynamics with high accuracy, the timing suitable for disconnecting the extracorporeal circulation device can be determined with high accuracy.

Prior Art Documents

Patent Documents

[0011]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0012] The present invention has been made to solve the above problems, and an object thereof is to provide an extracorporeal circulation device capable of accurately determining the timing suitable for disconnection.

Means for Solving the Problems

[0013] An extracorporeal circulation device that extracorporeally circulates blood using a circulation circuit, comprising a blood withdrawal catheter, a part of which is inserted into a patient and guides the blood taken out from the patient; a pump that withdraws the blood from the patient and returns the blood to the patient; a blood delivery catheter provided downstream of the pump, a part of which is inserted into the patient and guides the blood sent out from the pump to the patient; and At a predetermined time which is the rotational speed a pump rotation speed detection unit that detects the rotation speed of the pump; and a control system having at least one of an extracorporeal circulation management system that determines the stability of the dynamics of the extracorporeal circulation and a cardiac function measurement system that determines the stability of the cardiac function of the patient. The control system has both the extracorporeal circulation management system and the cardiac function measurement system, and has a comprehensive judgment system for judging the overall stability of the extracorporeal circulation device. The extracorporeal circulation management system includes a pump blood flow rate fluctuation width determination unit for determining a pump blood flow rate fluctuation width indicating a fluctuation width of the blood flow rate sent out from the pump at the rotational speed detected by the pump rotational speed detection unit based on the measurement result of a flow rate measurement unit provided in the circulation circuit; and a circulation stability determination unit for determining a circulation stability indicating the dynamic stability of the extracorporeal circulation based on a reference blood flow rate fluctuation width indicating a standard fluctuation width of the blood flow rate sent out from the pump and the pump blood flow rate fluctuation width determined by the pump blood flow rate fluctuation width determination unit. The cardiac function measurement system includes an arterial pressure change width determination unit for determining an arterial pressure change width indicating a change width between a first arterial pressure of the blood flowing through the patient's artery at a first rotational speed which is the rotational speed of the pump detected by the pump rotational speed detection unit and a second arterial pressure of the blood flowing through the patient's artery at a second rotational speed which is the rotational speed of the pump detected by the pump rotational speed detection unit based on the measurement result of an arterial pressure measurement unit provided in the patient; and a cardiac function stability determination unit for determining a cardiac function stability indicating the stability of the patient's cardiac function based on a reference pressure change width indicating a standard change width between the first arterial pressure and the second arterial pressure and the arterial pressure change width determined by the arterial pressure change width determination unit. The comprehensive judgment system includes a comprehensive stability determination unit for determining a comprehensive stability indicating the overall stability of the extracorporeal circulation device based on the circulation stability determined by the circulation stability determination unit and the cardiac function stability determined by the cardiac function stability determination unit; and a comprehensive stability judgment unit for judging the overall stability of the extracorporeal circulation device based on the comprehensive stability determined by the comprehensive stability determination unit. It is solved by an extracorporeal circulation device characterized by the above.

[0014] According to the extracorporeal circulation device of the present invention, the control system has at least one of an extracorporeal circulation management system and a cardiac function measurement system. The extracorporeal circulation management system determines the stability of the dynamics of the extracorporeal circulation. The cardiac function measurement system determines the stability of the cardiac function of the patient. Thus, the control system includes at least one of an extracorporeal circulation management system that determines the stability of the dynamics of the extracorporeal circulation as one of the criteria for determining the timing suitable for the detachment of the extracorporeal circulation device, and a cardiac function measurement system that determines the stability of the cardiac function of the patient as one of the criteria for determining the timing suitable for the detachment of the extracorporeal circulation device. Therefore, the control system of the extracorporeal circulation device according to the present invention can determine the timing suitable for the detachment of the extracorporeal circulation device with high accuracy. Also, according to the extracorporeal circulation device of the present invention, the control system has both an extracorporeal circulation management system and a cardiac function measurement system, and has a comprehensive judgment system for judging the overall stability of the extracorporeal circulation device. The extracorporeal circulation management system includes a pump blood flow rate fluctuation range determination unit and a circulation stability determination unit. The pump blood flow rate fluctuation range determination unit determines the pump blood flow rate fluctuation range based on the measurement result of the flow rate measurement unit provided in the circulation circuit. The pump blood flow rate fluctuation range indicates the fluctuation range of the blood flow rate sent out from the pump at the rotation speed of the pump detected by the pump rotation speed detection unit. Also, the circulation stability determination unit determines the circulation stability based on the reference blood flow rate fluctuation range and the pump blood flow rate fluctuation range. The reference blood flow rate fluctuation range indicates the standard fluctuation range of the blood flow rate sent out from the pump. The circulation stability indicates the stability of the dynamics of extracorporeal circulation. The cardiac function measurement system includes an arterial pressure change range determination unit and a cardiac function stability determination unit. The arterial pressure change range determination unit determines the arterial pressure change range based on the measurement result of the arterial pressure measurement unit provided in the patient. The arterial pressure change range indicates the change range between the first arterial pressure and the second arterial pressure. The first arterial pressure is the pressure of the blood flowing through the patient's artery at the first rotation speed of the pump detected by the pump rotation speed detection unit. The second arterial pressure is the pressure of the blood flowing through the patient's artery at the second rotation speed of the pump detected by the pump rotation speed detection unit. Also, the cardiac function stability determination unit determines the cardiac function stability based on the reference pressure change range and the arterial pressure change range determined by the arterial pressure change range determination unit. The reference pressure change range indicates the standard change range between the first arterial pressure and the second arterial pressure. The cardiac function stability indicates the stability of the patient's cardiac function. The comprehensive judgment system includes a comprehensive stability determination unit and a comprehensive stability judgment unit. The comprehensive stability determination unit determines the comprehensive stability based on the circulation stability determined by the circulation stability determination unit and the cardiac function stability determined by the cardiac function stability determination unit. The comprehensive stability indicates the comprehensive stability of the extracorporeal circulation device. Then, the comprehensive stability judgment unit judges the comprehensive stability of the extracorporeal circulation device based on the comprehensive stability determined by the comprehensive stability determination unit. Thereby, the control system of the extracorporeal circulation device according to the present invention can judge both the stability of the dynamics of extracorporeal circulation and the stability of the patient's cardiac function with high accuracy, and can judge the timing suitable for the detachment of the extracorporeal circulation device with even higher accuracy.

[0015] In the extracorporeal circulation device according to the present invention, preferably, the extracorporeal circulation management system determines a pump blood flow rate variation width indicating a variation width of the blood flow rate sent out from the pump at the rotation speed detected by the pump rotation speed detection unit based on the measurement result of a flow rate measurement unit provided in the circulation circuit, a pump blood flow rate variation width determination unit; a circulation stability determination unit that determines a circulation stability indicating the stability of the dynamics of the extracorporeal circulation based on a reference blood flow rate variation width indicating a standard variation width of the blood flow rate sent out from the pump and the pump blood flow rate variation width determined by the pump blood flow rate variation width determination unit; and a circulation stability determination unit that determines a circulation stability indicating the stability of the dynamics of the extracorporeal circulation based on the circulation stability determined by the circulation stability determination unit, and a circulation stability determination unit that determines a circulation stability indicating the stability of the dynamics of the extracorporeal circulation based on the circulation stability determined by the circulation stability determination unit.

[0016] According to the extracorporeal circulation device of the present invention, the extracorporeal circulation management system includes a pump blood flow rate variation width determination unit, a circulation stability determination unit, and a circulation stability determination unit. The pump blood flow rate variation width determination unit determines the pump blood flow rate variation width based on the measurement result of the flow rate measurement unit provided in the circulation circuit. The pump blood flow rate variation width indicates the variation width of the blood flow rate sent out from the pump at the rotation speed of the pump detected by the pump rotation speed detection unit. Further, the circulation stability determination unit determines the circulation stability based on the reference blood flow rate variation width and the pump blood flow rate variation width. The reference blood flow rate variation width indicates the standard variation width of the blood flow rate sent out from the pump. The circulation stability indicates the stability of the dynamics of the extracorporeal circulation. Then, the circulation stability determination unit determines the stability of the dynamics of the extracorporeal circulation based on the circulation stability determined by the circulation stability determination unit. In this way, the extracorporeal circulation management system determines the circulation stability based on the reference blood flow rate variation width and the pump blood flow rate variation width, and determines the stability of the dynamics of the extracorporeal circulation based on the circulation stability. Thereby, the control system of the extracorporeal circulation device according to the present invention can determine the stability of the dynamics of the extracorporeal circulation with high accuracy, and can determine the timing suitable for the detachment of the extracorporeal circulation device with high accuracy.

[0017] In addition, since the control system of the extracorporeal circulation device according to the present invention can determine the stability of the dynamics of extracorporeal circulation with high accuracy, it can detect a sign of a decrease in the stability of the dynamics of extracorporeal circulation. Therefore, medical staff can, for example, adjust the position of the tip of the blood withdrawal catheter, supplement a liquid such as physiological saline, or perform blood transfusion at a more appropriate timing, and can suppress a decrease in the stability of the dynamics of extracorporeal circulation. As a result, the amount of liquid such as physiological saline to be supplemented and the amount of blood transfusion can be suppressed.

[0018] In the extracorporeal circulation device according to the present invention, preferably, the control system further includes a display processing unit that executes a process of displaying at least one of a graph showing the relationship between the circulation stability and the elapsed time and a numerical value indicating the circulation stability on a display unit.

[0019] According to the extracorporeal circulation device according to the present invention, medical staff can easily check the circulation stability indicating the stability of the dynamics of extracorporeal circulation by checking the display unit, and can visually grasp the timing suitable for the removal of the extracorporeal circulation device. In addition, by checking the display unit, medical staff can review interventions or treatments such as adjusting the position of the tip of the blood withdrawal catheter, supplementing a liquid such as physiological saline, or performing blood transfusion.

[0023] In the extracorporeal circulation device according to the present invention, preferably, the control system further includes a display processing unit that executes a process of displaying at least one of a graph showing the relationship between the cardiac function stability and the elapsed time and a numerical value indicating the cardiac function stability on a display unit.

[0024] According to the extracorporeal circulation device according to the present invention, medical staff can easily check the cardiac function stability indicating the stability of the patient's cardiac function by checking the display unit, and can visually grasp the timing suitable for the removal of the extracorporeal circulation device.

[0027] In the extracorporeal circulation device according to the present invention, preferably, the control system further includes a display processing unit that executes a process of displaying on a display unit at least any one of a graph showing the relationship between the circulation stability and the elapsed time, a numerical value indicating the circulation stability, a graph showing the relationship between the cardiac function stability and the elapsed time, a numerical value indicating the cardiac function stability, a graph showing the relationship between the overall stability and the elapsed time, and a numerical value indicating the overall stability.

[0028] According to the extracorporeal circulation device of the present invention, medical staff can easily check, by checking the display unit, the circulation stability indicating the stability of the dynamics of extracorporeal circulation, the cardiac function stability indicating the stability of the patient's cardiac function, and the overall stability indicating the overall stability of the extracorporeal circulation device, and can more reliably and visually grasp the timing suitable for the removal of the extracorporeal circulation device.

Effects of the Invention

[0029] According to the present invention, it is possible to provide an extracorporeal circulation device capable of determining with high accuracy the timing suitable for removal.

Brief Description of the Drawings

[0030]

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Embodiments for Carrying Out the Invention

[0031] Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the drawings. It should be noted that the embodiments described below are preferred specific examples of the present invention, and thus are technically preferably subject to various limitations. However, the scope of the present invention is not limited to these aspects unless otherwise specifically stated in the following description to limit the present invention. In addition, in each drawing, the same reference numerals are assigned to the same components, and detailed descriptions thereof are omitted as appropriate.

[0032] FIG. 1 is a schematic diagram showing an extracorporeal circulation device according to an embodiment of the present invention. The "extracorporeal circulation" performed by the extracorporeal circulation device 1 shown in FIG. 1 includes an "extracorporeal circulation operation" and an "auxiliary circulation operation". The extracorporeal circulation device 1 can perform both the "extracorporeal circulation operation" and the "auxiliary circulation operation".

[0033] The "extracorporeal circulation operation" means that, for example, when the blood circulation in the heart is temporarily stopped by cardiac surgery, the blood circulation operation and the gas exchange operation for the blood (oxygen addition and / or carbon dioxide removal) are performed by the extracorporeal circulation device 1. In addition, the "auxiliary circulation operation" means that when the heart of the patient P to which the extracorporeal circulation device 1 is applied cannot perform sufficient functions, or when the gas exchange by the lungs cannot be sufficiently performed, the blood circulation operation and the gas exchange operation for the blood are also performed by the extracorporeal circulation device 1. In the description of the present embodiment, the "auxiliary circulation operation" is mainly taken as an example.

[0034] For example, the extracorporeal circulation device 1 is applied when the heart of patient P does not operate normally, or when the heart of patient P operates normally but the lungs do not operate normally. By the way, the extracorporeal circulation device 1 shown in FIG. 1 is used, for example, when performing cardiac surgery on patient P or during subsequent treatment in the ICU. The extracorporeal circulation device 1 shown in FIG. 1 operates the pump of the extracorporeal circulation device 1 to draw blood from the patient's vein, performs gas exchange in the blood by means of an artificial lung to oxygenate the blood, and then can perform artificial lung extracorporeal blood circulation to return the oxygenated blood to the patient's artery or vein again. Thus, the extracorporeal circulation device 1 is a device that substitutes for the heart and lungs.

[0035] As shown in FIG. 1, the extracorporeal circulation device 1 has a circulation circuit 1R for circulating blood. The circulation circuit 1R has an artificial lung 2, a centrifugal pump 3, a drive motor 4 for driving the centrifugal pump 3, a blood-drawing catheter (venous catheter) 5, a blood-sending catheter (arterial catheter) 6, and a control system 10. The centrifugal pump 3 of the present embodiment is an example of the "pump" of the present invention. The control system 10 has a control unit 40 and is provided as a controller of the extracorporeal circulation device 1. Note that the centrifugal pump 3 is also called a blood pump or the like and may be a pump other than a centrifugal type.

[0036] The blood extraction catheter 5, also called a venous cannula (blood extraction catheter), etc., is inserted from the femoral vein. The tip of the blood extraction catheter 5 is placed in the right atrium. The base of the blood extraction catheter 5 is arranged outside the femoral vein. The blood extraction catheter 5 is liquid-tightly connected to the blood extraction tube 11 via a connector 8a provided at the base of the blood extraction catheter 5 and a connector 8b provided at the tip of the blood extraction tube (also called a blood extraction line) 11, and is connected to the centrifugal pump 3 via the blood extraction tube 11, guiding the blood taken out from the patient P to the centrifugal pump 3 via the blood extraction tube 11. The blood extraction tube 11 is a pipeline connecting the blood extraction catheter 5 and the centrifugal pump 3, and is a pipeline guiding the blood taken out from the patient P to the centrifugal pump 3 via the blood extraction catheter 5. The connectors 8a and 8b are formed so that no pressure loss occurs in the blood flow inside the blood extraction catheter 5 and the blood extraction tube 11.

[0037] The blood infusion catheter 6, also called an arterial cannula (blood infusion catheter), etc., is inserted from the femoral artery. The tip of the blood infusion catheter 6 is placed inside the femoral artery. The base of the blood infusion catheter 6 is arranged outside the femoral artery. The blood infusion catheter 6 is liquid-tightly connected to the blood infusion tube 12 via a connector 9a provided at the base of the blood infusion catheter 6 and a connector 9b provided at the tip of the blood infusion tube (also called a blood infusion line) 12, and is connected to the artificial lung 2 via the blood infusion tube 12, guiding the blood that has passed through the artificial lung 2 to the patient P via the blood infusion tube 12. The blood infusion tube 12 is a pipeline connecting the artificial lung 2 and the blood infusion catheter 6, and is a pipeline guiding the blood that has passed through the artificial lung 2 to the patient P. The connectors 9a and 9b are formed so that no pressure loss occurs in the blood flow inside the blood infusion catheter 6 and the blood infusion tube 12.

[0038] The drive motor 4 controls the drive of the centrifugal pump 3 based on the command SG of the control system 10. The centrifugal pump 3 is provided downstream of the blood extraction side catheter 5 and is driven by receiving the driving force transmitted from the drive motor 4. The centrifugal pump 3 extracts blood from the patient P through the blood extraction side catheter 5 and the blood extraction tube 11, sends it to the artificial lung 2, and then returns the blood to the patient P through the blood delivery tube 12 and the blood delivery side catheter 6. Further, at least one of the centrifugal pump 3 and the drive motor 4 has a pump rotation speed detection unit 36. The pump rotation speed detection unit 36 detects the rotation speed of the centrifugal pump 3 and transmits a signal G regarding the rotation speed of the centrifugal pump 3 to the control system 10.

[0039] The artificial lung 2 is provided downstream of the centrifugal pump 3. Specifically, the artificial lung 2 is disposed between the centrifugal pump 3 and the blood delivery tube 12. The artificial lung 2 performs a gas exchange operation (oxygen addition and / or carbon dioxide removal) on the blood. The artificial lung 2 is, for example, a membrane type artificial lung, and particularly preferably a hollow fiber membrane type artificial lung. Oxygen gas is supplied to the artificial lung 2 through the oxygen supply tube 14.

[0040] As the blood extraction tube 11 and the blood delivery tube 12, for example, a synthetic resin pipeline made of a highly transparent and elastically deformable flexible material such as vinyl chloride resin or silicone rubber is used. The liquid blood flows in the V1 direction and the V2 direction in the blood extraction tube 11 and in the V3 direction in the blood delivery tube 12.

[0041] The control system 10 acquires various information, performs calculations, generates control signals for controlling the operations of devices such as the drive motor 4 and the external monitor 16, and transmits them to each device. In other words, the control system 10 manages the extracorporeal circulation device 1. Details of the control system 10 will be described later. Further, the control system 10 may have a touch panel 52 (see FIG. 5) as an input unit capable of inputting various information and as a display unit for displaying various information. That is, the "display unit" of the present invention may be an external monitor 16 provided separately from the control system 10, or may be the touch panel 52 possessed by the control system 10. The touch panel 52 is capable of detecting contact of a finger of an operator or the like.

[0042] The extracorporeal circulation device 1 according to the present embodiment further includes a flow rate measurement unit 21, an arterial pressure measurement unit 37, and an external monitor (display unit) 16. The external monitor 16 of the present embodiment is an example of the "display unit" of the present invention. In the following description, the case where the "display unit" of the present invention is the external monitor 16 will be taken as an example.

[0043] The flow rate measurement unit 21 is provided in the circulation circuit 1R. In the extracorporeal circulation device 1 according to the present embodiment, the flow rate measurement unit 21 is provided in the circulation circuit 1R between the artificial lung 2 and the blood delivery catheter 6. Specifically, the flow rate measurement unit 21 is provided in the blood delivery tube 12. By being provided in the blood delivery tube 12, the flow rate measurement unit 21 can measure the flow rate of the blood immediately before it is returned to the patient P, and can measure the flow rate of the blood flowing through the circulation circuit 1R at a position relatively close to the patient P. However, the installation position of the flow rate measurement unit 21 is not limited to the blood delivery tube 12, and may be any location in the circulation circuit 1R. In the following description, the case where the flow rate measurement unit 21 is provided in the blood delivery tube 12 will be taken as an example.

[0044] The flow rate measurement unit 21 is, for example, a non-invasive flow sensor, which is provided at an appropriate position outside the blood delivery tube 12 and detects the flow rate of the blood flowing inside the circulation circuit 1R. The flow rate measurement unit 21 shown in FIG. 1 measures the flow rate of the blood delivered from the centrifugal pump 3. The flow rate measurement unit 21 transmits a signal S1 regarding the flow rate of the blood flowing inside the circulation circuit 1R to the control system 10. In the present embodiment, the flow rate measurement unit 21 transmits a signal S1 regarding the flow rate of the blood delivered from the centrifugal pump 3 to the control system 10. Examples of the flow rate measurement unit 21 include an ultrasonic flow meter. As the ultrasonic flow meter, for example, a flow meter using the ultrasonic propagation time difference method is used. However, the flow rate measurement unit 21 is not limited to the ultrasonic flow meter.

[0045] The arterial pressure measurement unit 37 is provided, for example, at a position corresponding to the radial artery of the patient P's wrist and measures the pressure (arterial pressure) of the blood flowing through the artery of the patient P. The arterial pressure measurement unit 37 may measure the arterial pressure of the patient P by an invasive arterial pressure measurement method or may measure the arterial pressure of the patient P by a non-invasive arterial measurement method. The arterial pressure measurement unit 37 is, for example, a pressure sensor and transmits a signal S7 regarding the pressure (arterial pressure) of the blood flowing through the artery of the patient P to the control system 10. Specific examples of the arterial pressure measurement unit 37 by a non-invasive arterial measurement method include, for example, a tonometry pressure sensor that measures a pulse wave by directly pressing a pressure sensor against the skin and calculates blood pressure from the pulse wave.

[0046] FIG. 2 is a schematic diagram for explaining the flow of the blood returned from the extracorporeal circulation device to the patient and the flow of the blood delivered from the patient's heart. FIG. 3 is a block diagram for explaining the control unit and the flow rate measurement unit of the present embodiment. In addition, in the block diagram shown in FIG. 3, the artificial lung is omitted for convenience of explanation.

[0047] As shown by arrow A1 in FIG. 2 and arrow A3 in FIG. 3, the blood returned from the centrifugal pump 3 to the patient P through the blood delivery tube 12 and the blood delivery side catheter 6 flows, for example, through the artery towards the heart P1 of the patient P. On the other hand, as shown by arrow A2 in FIG. 2 and arrow A4 in FIG. 3, the blood pumped out from the heart P1 of the patient P and oxygenated in the lungs of the patient P flows through the artery towards the peripheral blood vessels in the head and the peripheral blood vessels in the lower limbs.

[0048] In this way, the direction of the blood flow returned to the body of the patient P by the centrifugal pump 3 is opposite to the direction of the blood flow flowing in the body of the patient P. That is, the centrifugal pump 3 returns the blood that has passed through the artificial lung 2 to the patient P in a state having retrograde.

[0049] As shown in FIG. 3, the control unit 40 of the control system 10 includes a CPU (central processing unit) 48 and an FPGA (field programmable gate array) 49. For example, the CPU 48 transmits a signal S2 requesting measurement of the blood flow rate delivered from the centrifugal pump 3 to the FPGA 49 every 50 milliseconds (ms). The FPGA 49 receives the signal S2 transmitted from the CPU 48 and transmits a signal S3 requesting measurement of the blood flow rate delivered from the centrifugal pump 3 to the flow rate measurement unit 21 every 50 ms. The flow rate measurement unit 21 receives the signal S3 transmitted from the FPGA 49, measures the blood flow rate delivered from the centrifugal pump 3 every 50 ms, and transmits a signal S4 regarding the measured blood flow rate to the FPGA 49. The FPGA 49 receives the signal S4 transmitted from the flow rate measurement unit 21 and transmits a signal S5 regarding the average value of the flow rate in the most recent one second to the CPU 48.

[0050] In this embodiment, since the flow rate measurement unit 21 measures the blood flow rate every 50 ms and transmits a signal S4 related to the measured blood flow rate to the FPGA 49, there are 20 measurement data per second (1 s / 50 ms). Therefore, the FPGA 49 calculates the average value of the 20 measurement data as the average value of the flow rate in the most recent one second, and transmits a signal S5 related to the average value of the flow rate to the CPU 48. The CPU 48 receives the signal S5 transmitted from the FPGA 49, and executes control to display the blood flow rate sent out from the centrifugal pump 3 on the external monitor (display unit) 16 as the pump blood flow rate. In this embodiment, the pump blood flow rate is the average value of the flow rate in the most recent one second, that is, the average value of 20 measurement data.

[0051] Note that the period at which the flow rate measurement unit 21 measures the blood flow rate is not necessarily limited to 50 ms. Also, the predetermined time when the CPU 48 calculates the average value of the blood flow rate is not necessarily limited to one second.

[0052] FIG. 4 is a block diagram showing the main configuration of the control system according to this embodiment. The control system 10 according to this embodiment includes a computer 51 and a storage unit 30. The computer 51 has a control unit 40 (see FIGS. 1 and 5), reads out a program 31 stored in the storage unit 30, and executes various calculations and processes. The storage unit 30 stores a program 31 (control program) executed by the computer 51. The program 31 of this embodiment is an example of the "control program" of the present invention. Examples of the storage unit 30 include a hard disk drive (HDD). Note that the program 31 is not necessarily limited to being stored in the storage unit 30, and may be pre-stored and distributed in a computer-readable storage medium, or may be downloaded to the control system 10 via a network. Also, the storage unit 30 may be an external storage device connected to the computer 51.

[0053] Next, the main configuration of the control system 10 according to this embodiment will be further described with reference to the drawings. FIG. 5 is a block diagram showing the main configuration of the control system according to the present embodiment.

[0054] The control system 10 according to the present embodiment includes a control unit 40, a storage unit 30, a touch panel 52, and a communication unit 53. The control unit 40 reads out a program 31 (see FIG. 4) stored in the storage unit 30 and executes various calculations and processes. The control unit 40 includes a display processing unit 41, a notification processing unit 42, an extracorporeal circulation management system 43, a cardiac function measurement system 44, and an integrated judgment system 45. The display processing unit 41, the notification processing unit 42, the extracorporeal circulation management system 43, the cardiac function measurement system 44, and the integrated judgment system 45 are realized by the computer 51 executing the program 31 stored in the storage unit 30. Note that the display processing unit 41, the notification processing unit 42, the extracorporeal circulation management system 43, the cardiac function measurement system 44, and the integrated judgment system 45 may be realized by hardware, or may be realized by a combination of hardware and software. The storage unit 30 stores the program 31 described above with respect to FIG. 4, and also includes a pump characteristic storage unit 32, a reference blood flow rate fluctuation range storage unit 33, and a reference pressure change range storage unit 34.

[0055] The display processing unit 41 executes a process of displaying at least any one of a graph showing the relationship between the circulation stability and the elapsed time, a numerical value indicating the circulation stability, a graph showing the relationship between the cardiac function stability and the elapsed time, a numerical value indicating the cardiac function stability, a graph showing the relationship between the overall stability and the elapsed time, and a numerical value indicating the overall stability on the external monitor 16. The "circulation stability" indicates the stability of the blood circulation dynamics in the circulation circuit 1R of the extracorporeal circulation device 1, that is, the stability of the extracorporeal circulation dynamics. The "cardiac function stability" indicates the degree of recovery of the cardiac function of the patient P, that is, the stability of the cardiac function of the patient P. The "overall stability" indicates the overall stability of the extracorporeal circulation device 1 including the circulation stability and the cardiac function stability. Details of the circulation stability, the cardiac function stability, and the overall stability will be described later.

[0056] The notification processing unit 42 performs notification on the external monitor 16 when a predetermined condition is satisfied. For example, when the circulation stability decreases or is low, the notification processing unit 42 executes a process of displaying on the external monitor 16 that the circulation stability has decreased or is low. For example, when the cardiac function stability decreases or is low, the notification processing unit 42 executes a process of displaying on the external monitor 16 that the cardiac function stability has decreased or is low. For example, when the overall stability decreases or is low, the notification processing unit 42 executes a process of displaying on the external monitor 16 that the overall stability has decreased or is low. For example, when a predetermined condition is satisfied, the notification processing unit 42 displays on the external monitor 16 that the current timing is suitable for the detachment of the extracorporeal circulation device 1, or displays on the external monitor 16 that the timing is late for the detachment of the extracorporeal circulation device 1. The method of notification by the notification processing unit 42 may be executed, for example, by generating light or sound. Note that in this specification, "detachment of the extracorporeal circulation device 1" includes both the case where the extracorporeal circulation device 1 is detached from the patient P by disconnecting the connector 8a and the connector 8b from each other and disconnecting the connector 9a and the connector 9b from each other, and the case where the extracorporeal circulation device 1 is detached from the patient P by removing the blood withdrawal catheter 5 and the blood supply catheter 6 from the patient P.

[0057] The extracorporeal circulation management system 43 includes a pump blood flow rate fluctuation range determination unit 431, a circulation stability determination unit 432, and a circulation stability determination unit 433. The pump blood flow rate fluctuation range determination unit 431 determines the pump blood flow rate fluctuation range based on the measurement result of the flow rate measurement unit 21. The pump blood flow rate fluctuation range indicates the fluctuation range of the blood flow rate delivered from the centrifugal pump 3 at the rotation speed of the centrifugal pump 3 detected by the pump rotation speed detection unit 36. For example, the pump blood flow rate fluctuation range determination unit 431 determines the pump blood flow rate fluctuation range at the rotation speed of the centrifugal pump 3 based on the measurement data of the flow rate measurement unit 21 in the most recent predetermined time. Alternatively, the pump blood flow rate fluctuation range determination unit 431 may determine the pump blood flow rate fluctuation range at the rotation speed of the centrifugal pump 3 based on, for example, a table stored in the pump characteristic storage unit 32. Alternatively, the pump blood flow rate fluctuation range determination unit 431 may determine the pump blood flow rate fluctuation range at the rotation speed of the centrifugal pump 3 based on, for example, a calculation formula stored in the pump characteristic storage unit 32 and at least one of the rotation speed of the centrifugal pump 3 detected by the pump rotation speed detection unit 36 and the measurement data of the flow rate measurement unit 21. Note that the above-described table and calculation formula may be stored in other parts of the storage unit 30 instead of the pump characteristic storage unit 32.

[0058] The circulation stability determination unit 432 determines the circulation stability based on the reference blood flow rate fluctuation range and the pump blood flow rate fluctuation range determined by the pump blood flow rate fluctuation range determination unit 431. The "reference blood flow rate fluctuation range" indicates the standard fluctuation range of the blood flow rate delivered from the centrifugal pump 3. For example, the circulation stability determination unit 432 reads out the reference blood flow rate fluctuation range stored in the reference blood flow rate fluctuation range storage unit 33. Alternatively, the circulation stability determination unit 432 may determine the reference blood flow rate fluctuation range based on the pump characteristics indicating the relationship between the flow rate of the centrifugal pump 3 and the discharge pressure (i.e., head) of the centrifugal pump 3. The pump characteristics are stored, for example, in the pump characteristic storage unit 32. Also, the circulation stability is as described above.

[0059] The circulation stability determination unit 433 determines the stability of the dynamics of extracorporeal circulation, that is, the stability of the dynamics of blood circulation in the circulation circuit 1R of the extracorporeal circulation device 1, based on the circulation stability determined by the circulation stability determination unit 432. For example, when the circulation stability determined by the circulation stability determination unit 432 is less than a predetermined threshold, the circulation stability determination unit 433 determines that the dynamics of extracorporeal circulation are not stable. On the other hand, when the circulation stability determined by the circulation stability determination unit 432 is greater than or equal to a predetermined threshold, the circulation stability determination unit 433 determines that the dynamics of extracorporeal circulation are stable. Note that the determination method of the circulation stability determination unit 433 is not limited to this.

[0060] The cardiac function measurement system 44 includes an arterial pressure change width determination unit 441, a cardiac function stability determination unit 442, and a cardiac function stability determination unit 443. The arterial pressure change width determination unit 441 determines the arterial pressure change width based on the measurement result of the arterial pressure measurement unit 37. The arterial pressure change width indicates the change width (for example, the difference) of the arterial pressure of the blood flowing through the artery of the patient P at different rotation speeds of the centrifugal pump 3 detected by the pump rotation speed detection unit 36. For example, the arterial pressure change width determination unit 441 determines the first arterial pressure of the blood flowing through the artery of the patient P at the first rotation speed (previous rotation speed) of the centrifugal pump 3 detected by the pump rotation speed detection unit 36 and the second rotation speed (latest rotation speed) of the centrifugal pump 3 detected by the pump rotation speed detection unit 36. The second arterial pressure of the blood flowing through the artery of the patient P is calculated based on the measurement data in the most recent predetermined time of the arterial pressure measurement unit 37. Then, the arterial pressure change width determination unit 441 determines the arterial pressure change width indicating the change width between the first arterial pressure and the second arterial pressure.

[0061] The "arterial pressure" in this specification may be the average value (mean arterial pressure) of the measurement data of the arterial pressure measurement unit 37 at a predetermined time, may be the arterial pressure during systole (maximum arterial pressure), or may be the arterial pressure during diastole (minimum arterial pressure). Alternatively, the "arterial pressure" in this specification may be the difference between the maximum arterial pressure and the minimum arterial pressure, or may be the amplitude of each of the maximum arterial pressure and the minimum arterial pressure.

[0062] The cardiac function stability determination unit 442 determines the cardiac function stability based on the reference pressure change width and the arterial pressure change width determined by the arterial pressure change width determination unit 441. The "reference pressure change width" indicates the standard change width (for example, the difference) between the first arterial pressure at the first rotation speed (previous rotation speed) of the centrifugal pump 3 and the second arterial pressure at the second rotation speed (latest rotation speed) of the centrifugal pump 3. For example, the cardiac function stability determination unit 442 reads out the reference pressure change width stored in the reference pressure change width storage unit 34. The reference pressure change width may be stored in the reference pressure change width storage unit 34 as a table set according to, for example, the information of the patient P (for example, height, weight, age, gender, etc.). Also, the cardiac function stability is as described above.

[0063] The cardiac function stability judgment unit 443 judges the stability of the cardiac function of the patient P, that is, the degree of recovery of the cardiac function of the patient P, based on the cardiac function stability determined by the cardiac function stability determination unit 442. For example, when the cardiac function stability determined by the cardiac function stability determination unit 442 is less than a predetermined threshold, the cardiac function stability judgment unit 443 judges that the cardiac function of the patient P is not stable, that is, the degree of recovery of the cardiac function of the patient P is low. On the other hand, when the cardiac function stability determined by the cardiac function stability determination unit 442 is equal to or higher than a predetermined threshold, the cardiac function stability judgment unit 443 judges that the cardiac function of the patient P is stable, that is, the degree of recovery of the cardiac function of the patient P is high. Note that the judgment method of the cardiac function stability judgment unit 443 is not limited to this.

[0064] The comprehensive judgment system 45 includes a comprehensive stability determination unit 451 and a comprehensive stability judgment unit 452. The comprehensive stability determination unit 451 determines the comprehensive stability based on the circulation stability determined by the circulation stability determination unit 432 and the cardiac function stability determined by the cardiac function stability determination unit 442. The comprehensive stability is as described above.

[0065] The overall stability determination unit 452 determines the overall stability of the extracorporeal circulation device 1 based on the overall stability determined by the overall stability determination unit 451. For example, when the overall stability determined by the overall stability determination unit 451 is less than a predetermined threshold, the overall stability determination unit 452 determines that the extracorporeal circulation device 1 is not overall stable. On the other hand, when the overall stability determined by the overall stability determination unit 451 is greater than or equal to a predetermined threshold, the overall stability determination unit 452 determines that the extracorporeal circulation device 1 is overall stable.

[0066] The touch panel 52 is an example of the "display unit" of the present invention, and is capable of displaying various information and detecting contact of a finger of an operator or the like. The touch panel 52 transmits the information input by the operator or the like to the control unit 40 according to the operation of the operator or the like.

[0067] The communication unit 53 communicates with the drive motor 4, the external monitor 16, the flow rate measurement unit 21, the arterial pressure measurement unit 37, and the pump rotation speed detection unit 36, and transmits and receives various information and various signals.

[0068] Here, in the assist circulation operation using the extracorporeal circulation device 1, determining the timing suitable for the detachment of the extracorporeal circulation device 1 is one of the important factors. That is, if the timing of the detachment of the extracorporeal circulation device 1 is too early, the patient's heart may not be able to withstand it, and it may be necessary to reattach the extracorporeal circulation device 1 or the patient may die. On the other hand, if the timing of the detachment of the extracorporeal circulation device 1 is too late, complications such as bleeding may occur due to the consumption of anticoagulant therapy, plasma components, etc. That is, there is an appropriate timing for the detachment of the extracorporeal circulation device 1. And it is desirable to be able to quickly identify the timing suitable for the detachment of the extracorporeal circulation device 1.

[0069] As criteria for determining the timing suitable for the detachment of the extracorporeal circulation device 1, for example, the stability of the blood circulation dynamics in the circulation circuit 1R of the extracorporeal circulation device 1, that is, the stability of the extracorporeal circulation dynamics can be mentioned. Further, as other criteria for determining the timing suitable for the detachment of the extracorporeal circulation device 1, the stability of the cardiac function of the patient P, in other words, the degree of recovery of the cardiac function of the patient P can be mentioned. The circulation stability indicating the stability of the blood circulation dynamics and the cardiac function stability indicating the stability of the cardiac function of the patient P will be further described with reference to the drawings.

[0070] First, the circulation stability will be explained. FIG. 6 is a graph for explaining the circulation stability. Note that FIG. 6(a) is a graph for explaining a state where the dynamics of the extracorporeal circulation are relatively stable. FIG. 6(b) is a graph for explaining a state where the dynamics of the extracorporeal circulation are not relatively stable. The horizontal axis of the graphs shown in FIGS. 6(a) and 6(b) represents the rotational speed of the centrifugal pump 3 detected by the pump rotational speed detection unit 36. The vertical axis of the graphs shown in FIGS. 6(a) and 6(b) represents the measurement result of the flow rate measurement unit 21, that is, the flow rate of the blood pumped out from the centrifugal pump 3 (pump blood flow rate).

[0071] According to the findings obtained by the present inventor, as shown in FIG. 6(a), when the dynamics of the extracorporeal circulation are relatively stable, in other words, when the circulation stability is relatively high, the variation width dQ1 of the pump blood flow rate is relatively small at a certain rotational speed of the centrifugal pump 3. As shown in FIG. 6(a), the tendency for the variation width dQ1 of the pump blood flow rate to be relatively small is substantially the same regardless of the rotational speed of the centrifugal pump 3.

[0072] On the other hand, according to the findings obtained by the present inventor, as shown in FIG. 6(b), when the dynamics of the extracorporeal circulation are not relatively stable, in other words, when the circulation stability is relatively low, the variation width dQ2 of the pump blood flow rate is relatively large at a certain rotational speed of the centrifugal pump 3. As shown in FIG. 6(b), the tendency for the variation width dQ2 of the pump blood flow rate to be relatively large is substantially the same regardless of the rotational speed of the centrifugal pump 3.

[0073] As one of the factors with relatively low circulatory stability or factors causing a decrease in circulatory stability, for example, there is poor blood withdrawal due to the tip of the blood withdrawal catheter 5 adhering to the blood vessel wall. When poor blood withdrawal occurs, medical staff administer, for example, physiological saline to the vein or perform blood transfusion based on their experience and knowledge. However, since replenishment of fluids such as physiological saline and blood transfusion are not methods for eliminating the root cause of poor blood withdrawal, there is a risk of recurrence of poor blood withdrawal. Also, considering that there is a risk that fluids such as physiological saline may leak outside the blood vessel and cause edema, it is desirable to suppress the amount of fluids such as physiological saline to be replenished and the amount of blood transfusion. Thus, the stability of the dynamics of extracorporeal circulation is often judged based on the experience and knowledge of medical staff, and it may be difficult to judge the stability of the dynamics of extracorporeal circulation with high accuracy.

[0074] Therefore, in the extracorporeal circulation device 1 according to the present embodiment, the extracorporeal circulation management system 43 judges the stability of the dynamics of extracorporeal circulation. That is, the control system 10 of the present embodiment has an extracorporeal circulation management system 43 that judges the stability of the dynamics of extracorporeal circulation as one of the criteria for judging the timing suitable for the detachment of the extracorporeal circulation device 1. Therefore, the extracorporeal circulation device 1 according to the present embodiment can judge the stability of the dynamics of extracorporeal circulation with high accuracy and can judge the timing suitable for the detachment of the extracorporeal circulation device 1 with high accuracy.

[0075] Next, the cardiac function stability will be described. FIG. 7 is a graph for explaining the cardiac function stability. Note that FIG. 7(a) is a graph for explaining a state where the cardiac function of the patient P is relatively stable. FIG. 7(b) is a graph for explaining a state where the cardiac function of the patient P is not relatively stable. The horizontal axis of the graphs shown in FIGS. 7(a) and 7(b) represents the rotational speed of the centrifugal pump 3 detected by the pump rotational speed detection unit 36. The vertical axis of the graphs shown in FIGS. 7(a) and 7(b) represents the measurement result of the arterial pressure measurement unit 37, that is, the pressure of the blood flowing through the artery of the patient P (mean arterial pressure in FIGS. 7(a) and 7(b)).

[0076] According to the findings obtained by the inventor, as shown in FIG. 7(a), when the cardiac function of patient P is relatively stable, in other words, when the cardiac function stability is relatively high, the change width dP1 of the mean arterial pressure of patient P is relatively small at different rotational speeds of the centrifugal pump 3. That is, when the degree of recovery of the cardiac function of patient P is relatively high and the dependence of patient P on the extracorporeal circulation device 1 is relatively low, even if the rotational speed of the centrifugal pump 3 is decreased, the change width dP1 of the mean arterial pressure of patient P is relatively small.

[0077] On the other hand, according to the findings obtained by the inventor, as shown in FIG. 7(b), when the cardiac function of patient P is not relatively stable, in other words, when the cardiac function stability is relatively low, the change width dP2 of the mean arterial pressure of patient P is relatively large at different rotational speeds of the centrifugal pump 3. That is, when the degree of recovery of the cardiac function of patient P is relatively low and the dependence of patient P on the extracorporeal circulation device 1 is relatively high, when the rotational speed of the centrifugal pump 3 is decreased, the change width dP2 of the mean arterial pressure of patient P is relatively large.

[0078] Therefore, in the extracorporeal circulation device 1 according to the present embodiment, the cardiac function measurement system 44 determines the stability of the cardiac function of patient P. That is, the control system 10 of the present embodiment has a cardiac function measurement system 44 that determines the stability of the cardiac function of patient P as one of the criteria for determining the timing suitable for the detachment of the extracorporeal circulation device 1. Therefore, the extracorporeal circulation device 1 according to the present embodiment can determine the stability of the cardiac function of patient P with high accuracy and can determine the timing suitable for the detachment of the extracorporeal circulation device 1 with high accuracy.

[0079] Next, a specific example of the operation of the extracorporeal circulation device 1 according to the present embodiment will be described with reference to the drawings. FIGS. 8 and 9 are flowcharts illustrating a first specific example of the operation of the extracorporeal circulation device according to the present embodiment. FIG. 10 is a graph illustrating an example of the relationship between the rotational speed of the centrifugal pump and the blood flow rate delivered by the centrifugal pump. FIG. 11 is a graph illustrating an example of the relationship between the circulation stability and the elapsed time. FIG. 12 is a schematic diagram illustrating an example of a screen on which both a graph showing the relationship between the circulation stability and the elapsed time and numerical values indicating the circulation stability are displayed on the display unit.

[0080] First, in step S11 shown in FIG. 8, the control unit 40 of the control system 10 determines whether there has been an operation to change the rotation speed of the centrifugal pump 3. That is, the control unit 40 determines whether the rotation speed of the centrifugal pump 3 has been changed based on the signal G regarding the rotation speed of the centrifugal pump 3 detected by the pump rotation speed detection unit 36. If there has been an operation to change the rotation speed of the centrifugal pump 3 (step S11: YES), in step S12, the control unit 40 updates the current value of the rotation speed of the centrifugal pump 3. If there has been no operation to change the rotation speed of the centrifugal pump 3 (step S11: NO), in step S13, the control unit 40 receives the signal S4 regarding the flow rate of the blood delivered from the centrifugal pump 3 (pump blood delivery flow rate) from the flow rate measurement unit 21.

[0081] Subsequently, in step S14, the pump blood delivery flow rate fluctuation width determination unit 431 of the extracorporeal circulation management system 43 calculates the fluctuation width of the flow rate of the blood delivered from the centrifugal pump 3 (pump blood delivery flow rate fluctuation width) at each rotation speed of the centrifugal pump 3 based on the measurement data of the flow rate measurement unit 21 in the most recent predetermined time. For example, in the example shown in FIG. 10, the pump blood delivery flow rate fluctuation width determination unit 431 calculates the pump blood delivery flow rate fluctuation width dQ11 at the rotation speed R11 of the centrifugal pump 3 based on the measurement data of the flow rate measurement unit 21 in the most recent predetermined time. Also, the pump blood delivery flow rate fluctuation width determination unit 431 calculates the pump blood delivery flow rate fluctuation width dQ12 at the rotation speed R12 of the centrifugal pump 3 based on the measurement data of the flow rate measurement unit 21 in the most recent predetermined time.

[0082] Subsequently, in step S15, the pump blood delivery flow rate fluctuation width determination unit 431 calculates the average value of the fluctuation widths of the flow rate of the blood delivered from the centrifugal pump 3. For example, in the example shown in FIG. 10, the pump blood delivery flow rate fluctuation width determination unit 431 calculates (dQ11 + dQ12) / 2 as the average value of the pump blood delivery flow rate fluctuation widths.

[0083] Subsequently, in step S16, the circulation stability determination unit 432 calculates the ratio (circulation stability) CS (see FIG. 11) between the reference blood flow rate fluctuation range and the average value of the pump blood flow rate fluctuation range calculated in step S14. The reference blood flow rate fluctuation range is as described above with respect to FIG. 5, and in this specific example, it is set to 0.7 L / min, for example. Then, in the example shown in FIG. 10, for example, the circulation stability determination unit 432 calculates 0.7 * 100 / ((dQ11 + dQ12) / 2) as the ratio (circulation stability) CS between the reference blood flow rate fluctuation range and the average value of the pump blood flow rate fluctuation range.

[0084] Subsequently, in step S17, the display processing unit 41 executes a process of displaying on the external monitor 16 a graph showing the relationship between the circulation stability CS and the elapsed time, and a numerical value indicating the circulation stability CS. Examples of the graph showing the relationship between the circulation stability CS and the elapsed time are as shown in graph 61A in FIG. 11 and graph 61B in FIG. 12, for example. Note that the graph showing the relationship between the circulation stability CS and the elapsed time is not limited to graph 61A in FIG. 11 and graph 61B in FIG. 12. Also, in the example of the screen display shown in FIG. 12, a graph 61B showing the relationship between the circulation stability CS and the elapsed time, a graph showing the relationship between the blood flow rate of the centrifugal pump 3 and the elapsed time (see FIG. 20), and a graph showing the relationship between the rotation speed of the centrifugal pump 3 and the elapsed time (FIG. 20) may be displayed. Details of this will be described later with respect to FIG. 20.

[0085] Also, an example of the numerical value indicating the circulation stability CS is displayed as "58" on the display screen shown in FIG. 12. That is, for example, assume that the pump blood flow rate fluctuation width dQ11 at the rotation speed R11 of the centrifugal pump 3 is 1.1 L / min. Also, assume that the pump blood flow rate fluctuation width dQ12 at the rotation speed R12 of the centrifugal pump 3 is 1.3 L / min. In this case, the average value of the pump blood flow rate fluctuation width is 1.2 L / min (= (1.1 + 1.3) / 2). Then, in this specific example, since the reference pump blood flow rate fluctuation width is 0.7 L / min, the numerical value indicating the circulation stability CS is "58 (≈ 0.7 * 100 / 1.2)". Note that the numerical value indicating the circulation stability CS is not limited to "58".

[0086] Subsequently, in step S18, the circulation stability determination unit 433 determines the stability of the dynamics of the extracorporeal circulation based on the circulation stability CS determined by the circulation stability determination unit 432. That is, the circulation stability determination unit 433 determines whether the circulation stability CS determined by the circulation stability determination unit 432 is less than a predetermined threshold value. If the circulation stability CS determined by the circulation stability determination unit 432 is less than the predetermined threshold value (step S18: YES), the circulation stability determination unit 433 determines that the dynamics of the extracorporeal circulation are not stable. Then, in step S19, the notification processing unit 42 executes a process of notifying the external monitor 16 that the circulation stability CS has decreased or is low.

[0087] On the other hand, if the circulation stability CS determined by the circulation stability determination unit 432 is greater than or equal to the predetermined threshold value (step S18: NO), the circulation stability determination unit 433 determines that the dynamics of the extracorporeal circulation are stable. Then, in step S21 shown in FIG. 9, the control unit 40 determines the timing suitable for the detachment of the extracorporeal circulation device 1 using the determination result of the circulation stability determination unit 433 as one of the criteria. That is, the control unit 40 determines whether the current timing is suitable for the detachment of the extracorporeal circulation device 1.

[0088] When it is the timing suitable for the extracorporeal circulation device 1 to be detached (step S21: YES), in step S22, the notification processing unit 42 notifies the external monitor 16 that it is the timing suitable for the extracorporeal circulation device 1 to be detached. On the other hand, when it is not the timing suitable for the extracorporeal circulation device 1 to be detached (step S21: NO), the process described above regarding step S11 is executed. In step S23 following step S22, the control unit 40 determines whether the extracorporeal circulation device 1 has been detached from the patient P. When the extracorporeal circulation device 1 has been detached from the patient P (step S23: YES), the control unit 40 terminates the operation of the extracorporeal circulation device 1.

[0089] On the other hand, when the extracorporeal circulation device 1 has not been detached from the patient P (step S23: NO), in step S24, the control unit 40 determines whether a predetermined time has elapsed since the notification processing unit 42 notified the external monitor 16 that it is the timing suitable for the extracorporeal circulation device 1 to be detached. For example, the control unit 40 uses the timer function of the control unit 40 to measure the time elapsed since the notification processing unit 42 notified the external monitor 16 that it is the timing suitable for the extracorporeal circulation device 1 to be detached.

[0090] When a predetermined time has elapsed since the notification processing unit 42 notified the external monitor 16 that it is the timing suitable for the extracorporeal circulation device 1 to be detached (step S24: YES), in step S25, the notification processing unit 42 notifies the external monitor 16 that it is the timing too late for the extracorporeal circulation device 1 to be detached. For example, the notification processing unit 42 pops up and displays on the external monitor 16 that it is the timing too late for the extracorporeal circulation device 1 to be detached using characters, graphics, symbols, etc. Alternatively, the notification processing unit 42 may notify by voice that it is the timing too late for the extracorporeal circulation device 1 to be detached.

[0091] On the other hand, when the notification processing unit 42 notifies the external monitor 16 that the current timing is suitable for the detachment of the extracorporeal circulation device 1 and a predetermined time has not elapsed (step S24: NO), the process described above with respect to step S23 is executed.

[0092] According to the extracorporeal circulation device 1 according to the present specific example, the extracorporeal circulation management system 43 determines the circulation stability CS based on the reference blood flow rate fluctuation range and the pump blood flow rate fluctuation range, and determines the stability of the dynamics of the extracorporeal circulation based on the circulation stability CS. Thereby, the control system 10 of the extracorporeal circulation device 1 according to the present specific example can determine the stability of the dynamics of the extracorporeal circulation with high accuracy, and can determine the timing suitable for the detachment of the extracorporeal circulation device 1 with high accuracy.

[0093] In addition, since the control system 10 of the extracorporeal circulation device 1 according to the present specific example can determine the stability of the dynamics of the extracorporeal circulation with high accuracy, it can detect a sign of a decrease in the stability of the dynamics of the extracorporeal circulation. Therefore, medical staff can, for example, adjust the position of the tip of the drainage catheter 5, replenish a liquid such as physiological saline, or perform blood transfusion at a more appropriate timing, and can suppress a decrease in the stability of the dynamics of the extracorporeal circulation. Thereby, the amount of the liquid such as physiological saline to be replenished and the amount of blood transfusion can be suppressed.

[0094] In addition, by checking the external monitor 16, medical staff can easily check the circulation stability CS indicating the stability of the dynamics of the extracorporeal circulation, and can visually grasp the timing suitable for the detachment of the extracorporeal circulation device 1. In addition, by checking the external monitor 16, medical staff can review interventions or treatments such as adjusting the position of the tip of the drainage catheter 5, replenishing a liquid such as physiological saline, or performing blood transfusion.

[0095] FIGS. 13 and 14 are flowcharts illustrating a second specific example of the operation of the extracorporeal circulation device according to the present embodiment. FIG. 15 is a graph illustrating an example of the relationship between the rotational speed of the centrifugal pump and the mean arterial pressure. FIG. 16 is a graph illustrating an example of the relationship between cardiac function stability and elapsed time. FIG. 17 is a schematic diagram illustrating an example of a screen on which both a graph showing the relationship between cardiac function stability and elapsed time and numerical values indicating cardiac function stability are displayed on a display unit.

[0096] First, the processes of step S31 and step S32 shown in FIG. 13 are the same as the processes of step S11 and step S12 described above with respect to FIG. 8. In step S33 following step S31 and step S32, the control unit 40 receives a signal S7 regarding the pressure (arterial pressure) of blood flowing through the artery of the patient P from the arterial pressure measurement unit 37.

[0097] Subsequently, in step S34, the arterial pressure change width determination unit 441 of the cardiac function measurement system 44 calculates, based on the measurement data of the arterial pressure measurement unit 37 in the most recent predetermined time period, the first arterial pressure of the blood flowing through the artery of the patient P at the first rotation speed (previous rotation speed) of the centrifugal pump 3 detected by the pump rotation speed detection unit 36 and the second arterial pressure of the blood flowing through the artery of the patient P at the second rotation speed (latest rotation speed) of the centrifugal pump 3 detected by the pump rotation speed detection unit 36. For example, in the example shown in FIG. 15, the arterial pressure change width determination unit 441 calculates the first average arterial pressure P13 as the first arterial pressure at the first rotation speed R13 based on the measurement data of the arterial pressure measurement unit 37 in the most recent predetermined time period. Further, the arterial pressure change width determination unit 441 calculates the second average arterial pressure P14 as the second arterial pressure at the second rotation speed R14 based on the measurement data of the arterial pressure measurement unit 37 in the most recent predetermined time period.

[0098] Subsequently, in step S35, the arterial pressure change width determination unit 441 calculates the change width (arterial pressure change width) between the first arterial pressure and the second arterial pressure. For example, in the example shown in FIG. 15, the arterial pressure change width determination unit 441 calculates the change width (arterial pressure change width) dP11 (=P13 - P14) between the first average arterial pressure P13 and the second average arterial pressure P14.

[0099] Subsequently, in step S36, the cardiac function stability determination unit 442 calculates the ratio (cardiac function stability) HS (see FIG. 16) between the reference pressure change width and the arterial pressure change width dP11 calculated in step S35. The reference pressure change width is as described above with respect to FIG. 5, and is, for example, 10 mmHg in this specific example. Then, for example, in the example shown in FIG. 15, the cardiac function stability determination unit 442 calculates 10 * 100 / dP11 as the ratio (cardiac function stability) HS between the reference pressure change width and the arterial pressure change width dP11.

[0100] Subsequently, in step S37, the display processing unit 41 executes a process of displaying on the external monitor 16 a graph showing the relationship between the cardiac function stability HS and the elapsed time, and a numerical value indicating the cardiac function stability HS. Examples of the graph showing the relationship between the cardiac function stability HS and the elapsed time are as shown in, for example, graph 61C shown in FIG. 16 and graph 61D shown in FIG. 17. Note that the graph showing the relationship between the cardiac function stability HS and the elapsed time is not limited to the graph 61C shown in FIG. 16 and the graph 61D shown in FIG. 17. Also, in the example of the screen display shown in FIG. 17, a graph 61D showing the relationship between the cardiac function stability HS and the elapsed time, a graph showing the relationship between the blood flow rate of the centrifugal pump 3 and the elapsed time (see FIG. 20), and a graph showing the relationship between the rotation speed of the centrifugal pump 3 and the elapsed time (FIG. 20) may be displayed. Details of this will be described later with respect to FIG. 20.

[0101] Also, an example of the numerical value indicating the cardiac function stability HS is displayed as "20" on the display screen shown in FIG. 17. That is, for example, assume that the first mean arterial pressure P13 at the first rotation speed of the centrifugal pump 3 is 100 mmHg. Also, assume that the second mean arterial pressure P14 at the second rotation speed of the centrifugal pump 3 is 50 mmHg. In this case, the arterial pressure change width dP11 is 50 mmHg (= 100 - 50). Then, in this specific example, since the reference pressure change width is 10 mmHg, the numerical value indicating the cardiac function stability HS is "20 (= 10 * 100 / 50)". Note that the numerical value indicating the cardiac function stability HS is not limited to "20".

[0102] Subsequently, in step S38, the cardiac function stability determination unit 443 determines the stability of the cardiac function of patient P based on the cardiac function stability HS determined by the cardiac function stability determination unit 442. That is, the cardiac function stability determination unit 443 determines whether the cardiac function stability HS determined by the cardiac function stability determination unit 442 is less than a predetermined threshold value. When the cardiac function stability HS determined by the cardiac function stability determination unit 442 is less than the predetermined threshold value (step S38: YES), the cardiac function stability determination unit 443 determines that the cardiac function of patient P is not stable, that is, the degree of recovery of the cardiac function of patient P is low. Then, in step S39, the notification processing unit 42 executes a process of notifying the external monitor 16 that the cardiac function stability HS has decreased or is low.

[0103] On the other hand, when the cardiac function stability HS determined by the cardiac function stability determination unit 442 is greater than or equal to the predetermined threshold value (step S38: NO), the cardiac function stability determination unit 443 determines that the cardiac function of patient P is stable, that is, the degree of recovery of the cardiac function of patient P is high. Then, in step S41 shown in FIG. 14, the control unit 40 determines the timing suitable for the detachment of the extracorporeal circulation device 1 based on the determination result of the cardiac function stability determination unit 443 as one of the criteria. That is, the control unit 40 determines whether the current timing is suitable for the detachment of the extracorporeal circulation device 1. Subsequently, the processes of steps S41 to S45 are the same as the processes of steps S21 to S25 described above with respect to FIG. 9.

[0104] According to the extracorporeal circulation device 1 according to this specific example, the cardiac function measurement system 44 determines the cardiac function stability HS based on the reference pressure change width and the arterial pressure change width dP11, and determines the stability of the cardiac function of patient P based on the cardiac function stability HS. Thereby, the control system 10 of the extracorporeal circulation device 1 according to this specific example can determine the stability of the cardiac function of patient P with high accuracy, and can determine the timing suitable for the detachment of the extracorporeal circulation device 1 with high accuracy.

[0105] In addition, since the control system 10 of the extracorporeal circulation device 1 according to the present specific example can determine the stability of the patient P's cardiac function with high accuracy, it is possible to suppress the timing of detachment of the extracorporeal circulation device 1 from being too early or too late, optimize the wearing time of the extracorporeal circulation device 1, and suppress the occurrence of complications.

[0106] In addition, by checking the external monitor 16, medical staff can easily check the cardiac function stability HS indicating the stability of the patient P's cardiac function, and visually grasp the timing suitable for detaching the extracorporeal circulation device 1.

[0107] FIG. 18 and FIG. 19 are flowcharts illustrating a third specific example of the operation of the extracorporeal circulation device according to the present embodiment. FIG. 20 is a timing chart illustrating the operation of the present specific example. FIG. 21 is a timing chart illustrating the operation of a comparative example.

[0108] First, the processes of steps S51 to S56 shown in FIG. 18 are the same as the processes of steps S11 to S16 described above with respect to FIG. 8. Also, the processes of steps S57 to S61 shown in FIG. 18 are the same as the processes of steps S33 to S36 described above with respect to FIG. 13.

[0109] In step S62 following step S61, the overall stability determination unit 451 of the comprehensive judgment system 45 calculates the overall stability (overall stability) TS of the extracorporeal circulation device 1 based on the circulation stability CS determined by the circulation stability determination unit 432 and the cardiac function stability HS determined by the cardiac function stability determination unit 442. For example, the overall stability determination unit 451 calculates (circulation stability CS * m + cardiac function stability HS * n) / (m + n) as the overall stability TS.

[0110] Subsequently, in step S63, the display processing unit 41 executes a process of displaying on the external monitor 16 a graph showing the relationship between the circulation stability CS and the elapsed time, a numerical value indicating the circulation stability CS, a graph showing the relationship between the cardiac function stability HS and the elapsed time, a numerical value indicating the cardiac function stability HS, a graph showing the relationship between the overall stability TS and the elapsed time, and a numerical value indicating the overall stability TS. An example of the graph showing the relationship between the circulation stability CS and the elapsed time is as shown by the graph 61E shown in FIG. 20, for example. An example of the graph showing the relationship between the cardiac function stability HS and the elapsed time is as shown by the graph 61F shown in FIG. 20, for example. An example of the graph showing the relationship between the overall stability TS and the elapsed time is as shown by the graph 61G shown in FIG. 20, for example. In the example shown in FIG. 20, for example, each of the aforementioned coefficient m and coefficient n is "1". Then, the overall stability determination unit 451 calculates (circulation stability CS + cardiac function stability HS) / 2 as the overall stability TS.

[0111] Subsequently, in step S64, the overall stability determination unit 452 determines the overall stability of the extracorporeal circulation device 1 based on the overall stability TS determined by the overall stability determination unit 451. That is, the overall stability determination unit 452 determines whether or not the overall stability TS determined by the overall stability determination unit 451 is less than a predetermined threshold value. If the overall stability TS determined by the overall stability determination unit 451 is less than the predetermined threshold value (step S64: YES), the overall stability determination unit 452 determines that the extracorporeal circulation device 1 is not overall stable. Then, in step S65, the notification processing unit 42 executes a process of notifying on the external monitor 16 that the overall stability TS has decreased or is low.

[0112] On the other hand, when the overall stability TS determined by the overall stability determination unit 451 is equal to or greater than a predetermined threshold value (step S64: NO), the overall stability determination unit 452 determines that the extracorporeal circulation device 1 is overall stable. Then, in step S66, the control unit 40 determines the timing suitable for the detachment of the extracorporeal circulation device 1 using the determination result of the overall stability determination unit 452 as one of the criteria. Subsequently, the processes from step S66 to step S71 are the same as the processes from step S21 to step S25 described above with reference to FIG. 9.

[0113] For example, in the comparative example shown in FIG. 21, while a graph 62J showing the relationship between the blood flow rate of the centrifugal pump 3 and the elapsed time and a graph 62K showing the relationship between the rotational speed of the centrifugal pump 3 and the elapsed time are displayed on the external monitor 16, graphs showing the relationship between the circulation stability CS and the elapsed time, the relationship between the cardiac function stability HS and the elapsed time, and the relationship between the overall stability TS and the elapsed time are not displayed on the external monitor 16. Then, at the timing T11 shown in FIG. 21, even if a medical staff notices that the blood flow rate of the centrifugal pump 3 has decreased and become unstable and performs replenishment of a liquid such as physiological saline or blood transfusion based on experience and knowledge, when the rotational speed of the centrifugal pump 3 is decreased at the timing T12 shown in FIG. 21, the blood flow rate of the centrifugal pump 3 decreases again and becomes unstable, and it is necessary to perform replenishment of a liquid such as physiological saline or blood transfusion at the timing T13 shown in FIG. 21.

[0114] In contrast, according to the extracorporeal circulation device 1 according to this specific example, as shown in FIG. 20, the display processing unit 41 executes a process of displaying on the external monitor 16 a graph 61J showing the relationship between the blood flow rate of the centrifugal pump 3 and the elapsed time, a graph 61K showing the relationship between the rotational speed of the centrifugal pump 3 and the elapsed time, a graph 61E showing the relationship between the circulation stability CS and the elapsed time, a graph 61F showing the relationship between the cardiac function stability HS and the elapsed time, and a graph 61G showing the relationship between the overall stability TS and the elapsed time.

[0115] Therefore, at timing T1 shown in FIG. 20, when the medical staff notices that the blood flow rate of the centrifugal pump 3 has decreased and become unstable, they can also notice that the circulation stability CS has decreased. Therefore, at timing T1 shown in FIG. 20, the medical staff can not only perform replenishment of a liquid such as physiological saline or blood transfusion, but also adjust the position of the tip of the blood withdrawal catheter 5. In this way, the medical staff can eliminate the root cause of the decrease in the circulation stability CS based on, for example, poor blood withdrawal. Therefore, even when the medical staff gradually decreases the rotation speed of the centrifugal pump 3 at timings T2, T3, and T4 shown in FIG. 20, it is possible to suppress the blood flow rate of the centrifugal pump 3 from decreasing again and becoming unstable. And like the graph 61F showing the relationship between the heart function stability HS and the elapsed time shown in FIG. 20, and the graph 61G showing the relationship between the overall stability TS and the elapsed time, even when the medical staff gradually decreases the rotation speed of the centrifugal pump 3, it is possible to suppress the decrease in the heart function stability HS and the overall stability TS. Thereby, the extracorporeal circulation device 1 according to this specific example can accurately determine the timing suitable for the detachment of the extracorporeal circulation device 1 with high accuracy.

[0116] Also, according to the extracorporeal circulation device 1 according to this specific example, the control system 10 can accurately determine both the stability of the dynamics of extracorporeal circulation and the stability of the heart function of the patient P, and can determine the timing suitable for the detachment of the extracorporeal circulation device 1 with even higher accuracy.

[0117] In addition, by checking the external monitor 16, the medical staff can easily check the circulation stability CS indicating the stability of the dynamics of extracorporeal circulation, the heart function stability HS indicating the stability of the heart function of the patient P, and the overall stability TS indicating the overall stability of the extracorporeal circulation device 1, and can more reliably and visually grasp the timing suitable for the detachment of the extracorporeal circulation device 1.

[0118] The embodiments of the present invention have been described above. However, the present invention is not limited to the above embodiments, and various modifications can be made without departing from the scope of the claims. The configurations of the above embodiments can be partially omitted or arbitrarily combined in a manner different from the above.

Explanation of Reference Numerals

[0119] 1: Extracorporeal circulation device, 1R: Circulation circuit, 2: Artificial lung, 3: Centrifugal pump, 4: Drive motor, 5: Blood withdrawal side catheter, 6: Blood delivery side catheter, 8a, 8b, 9a, 9b: Connector, 10: Control system, 11: Blood withdrawal tube, 12: Blood delivery tube, 14: Oxygen supply tube, 16: External monitor, 21: Flow rate measurement unit, 30: Storage unit, 31: Program, 32: Pump characteristic storage unit, 33: Reference blood delivery flow rate fluctuation range storage unit, 34: Reference pressure change range storage unit, 36: Pump rotation speed detection unit, 37: Arterial pressure measurement unit, 40: Control unit, 41: Display processing unit, 42: Notification processing unit, 43: Extracorporeal circulation management system, 44: Heart function measurement system, 45: Comprehensive judgment system, 48: CPU, 49: FPGA, 51: Computer, 52: Touch panel, 53: Communication unit, 61A, 61B, 61C, 61D, 61E, 61F, 61G, 61J, 61K, 62J, 62K: Graph, 431: Pump blood delivery flow rate fluctuation range determination unit, 432: Circulation stability determination unit, 433: Circulation stability judgment unit, 441: Arterial pressure change range determination unit, 442: Heart function stability determination unit, 443: Heart function stability judgment unit, 451: Comprehensive stability determination unit, 452: Comprehensive stability judgment unit, CS: Circulation stability, G: Signal, HS: Heart function stability, P: Patient, P1: Heart, P13: First mean arterial pressure, P14: Second mean arterial pressure, R11, R12: Rotation speed, R13: First rotation speed, R14: Second rotation speed, S1, S2, S3, S4, S5, S7: Signal, SG: Command, TS: Comprehensive stability, dP1: Change range, dP11: Arterial pressure change range, dP2: Change range, dQ1: Fluctuation range, dQ11, dQ12: Pump blood delivery flow rate fluctuation range, dQ2: Fluctuation range

Claims

【Claim 1】 An extracorporeal circulation device for extracorporeally circulating blood using a circulation circuit, comprising: a blood withdrawal catheter, a part of which is inserted into a patient and guides the blood taken out from the patient; a pump that extracts the blood from the patient and returns the blood to the patient; a blood delivery catheter provided downstream of the pump, a part of which is inserted into the patient and guides the blood sent out from the pump to the patient; a pump rotation speed detection unit that detects the number of rotations of the pump at a predetermined time, which is the rotation speed of the pump; a control system having at least one of an extracorporeal circulation management system for determining the stability of the dynamics of the extracorporeal circulation and a cardiac function measurement system for determining the stability of the cardiac function of the patient; The control system has both the extracorporeal circulation management system and the cardiac function measurement system, and has an overall judgment system for determining the overall stability of the extracorporeal circulation device. The extracorporeal circulation management system includes: a pump blood delivery flow rate variation width determination unit that determines a pump blood delivery flow rate variation width indicating the variation width of the flow rate of the blood sent out from the pump at the rotation speed detected by the pump rotation speed detection unit based on the measurement result of a flow rate measurement unit provided in the circulation circuit; a circulation stability determination unit that determines a circulation stability indicating the stability of the dynamics of the extracorporeal circulation based on a reference blood delivery flow rate variation width indicating a standard variation width of the flow rate of the blood sent out from the pump and the pump blood delivery flow rate variation width determined by the pump blood delivery flow rate variation width determination unit; The cardiac function measurement system includes: a first arterial pressure of the blood flowing through the artery of the patient at a first rotation speed, which is the rotation speed of the pump detected by the pump rotation speed detection unit, and a second arterial pressure of the blood flowing through the artery of the patient at a second rotation speed, which is the rotation speed of the pump detected by the pump rotation speed detection unit, and an arterial pressure variation width determination unit that determines an arterial pressure variation width indicating the variation width between the two based on the measurement result of an arterial pressure measurement unit provided in the patient; a cardiac function stability determination unit that determines a cardiac function stability indicating the stability of the cardiac function of the patient based on a reference pressure variation width indicating a standard variation width between the first arterial pressure and the second arterial pressure and the arterial pressure variation width determined by the arterial pressure variation width determination unit; The overall judgment system includes: a comprehensive stability determination unit that determines an overall stability indicating the overall stability of the extracorporeal circulation device based on the circulation stability determined by the circulation stability determination unit and the cardiac function stability determined by the cardiac function stability determination unit; The extracorporeal circulation device further includes: a display unit that displays at least one of the circulation stability determined by the circulation stability determination unit, the cardiac function stability determined by the cardiac function stability determination unit, and the overall stability determined by the comprehensive stability determination unit; A comprehensive stability determination unit that determines a comprehensive stability indicating the overall stability of the extracorporeal circulation device based on the circulation stability determined by the circulation stability determination unit and the cardiac function stability determined by the cardiac function stability determination unit; A comprehensive stability judgment unit that judges the overall stability of the extracorporeal circulation device based on the comprehensive stability determined by the comprehensive stability determination unit; An extracorporeal circulation device characterized by comprising the above. **Claim 2** The extracorporeal circulation management system A pump blood flow rate variation width determination unit that determines a variation width of the blood flow rate sent out from the pump at the rotation speed detected by the pump rotation speed detection unit based on the measurement result of a flow rate measurement unit provided in the circulation circuit; A circulation stability determination unit that determines a circulation stability indicating the dynamic stability of the extracorporeal circulation based on a reference blood flow rate variation width indicating a standard variation width of the blood flow rate sent out from the pump and the pump blood flow rate variation width determined by the pump blood flow rate variation width determination unit; A circulation stability judgment unit that judges the dynamic stability of the extracorporeal circulation based on the circulation stability determined by the circulation stability determination unit; The extracorporeal circulation device according to claim 1, characterized by comprising the above. **Claim 3** The control system further includes a display processing unit that executes a process of displaying at least one of a graph showing the relationship between the circulation stability and the elapsed time and a numerical value indicating the circulation stability on a display unit. The extracorporeal circulation device according to claim 2. **Claim 4** The control system further includes a display processing unit that executes a process of displaying at least one of a graph showing the relationship between the cardiac function stability and the elapsed time and a numerical value indicating the cardiac function stability on a display unit. The extracorporeal circulation device according to claim 1. **Claim 5** The control system further includes a display processing unit that executes a process of displaying at least one of a graph showing the relationship between the circulation stability and the elapsed time, a numerical value indicating the circulation stability, a graph showing the relationship between the cardiac function stability and the elapsed time, a numerical value indicating the cardiac function stability, a graph showing the relationship between the comprehensive stability and the elapsed time, and a numerical value indicating the comprehensive stability on a display unit. The extracorporeal circulation device according to claim 1.

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