Extracorporeal circulation device, extracorporeal circulation system, and method for controlling extracorporeal circulation device

Abstract

In the present invention, a control unit (90) of an extracorporeal circulation device (1) capable of ensuring an ideal blood flow rate for a patient when performing VA-ECMO comprises: a calculation unit (91) that calculates an ideal flow rate and pump head pressure from patient-specific information; and a transmission unit (92) that transmits, to a fluid replacement device (70) for performing fluid replacement, water amount data obtained through measurement by a measurement device (80) for measuring the water amount of the patient. The control unit (90) gives a fluid replacement instruction to the fluid replacement device (70) via the transmission unit (92) on the basis of the pressure of the inside of a blood circuit (20) measured by pressure measurement units (45, 46), the flow rate of the inside of the blood circuit (20) measured by a flow rate measurement unit (47), and the water amount data obtained through measurement by the measurement device (80).

Description

Extracorporeal circulation device, extracorporeal circulation system, and control method of extracorporeal circulation device

[0001] The present invention relates to an extracorporeal circulation device, an extracorporeal circulation system, and a control method of an extracorporeal circulation device.

[0002] Conventionally, for performing cardiopulmonary resuscitation, circulatory assistance, and respiratory assistance in emergency treatment, treatment by percutaneous cardiopulmonary support (PCPS: percutaneous cardiopulmonary support) has been performed. This percutaneous cardiopulmonary support method is a method of temporarily assisting and substituting cardiopulmonary functions using an extracorporeal membrane oxygenation device (ECMO: Extracorporeal membrane oxygenation).

[0003] An extracorporeal circulation system such as an extracorporeal membrane oxygenation device includes a blood circuit composed of a circulation pump, an artificial lung, a blood withdrawal path, a blood delivery path, etc., and performs gas exchange on the withdrawn blood and delivers it to the blood delivery path, as shown in Patent Document 1 below.

[0004] Japanese Patent Translation of PCT International Publication No. 2014-504906

[0005] In an extracorporeal circulation system, when treating a patient whose cardiopulmonary function is expected to recover from the primary disease with reduced cardiopulmonary function, venous-arterial ECMO (VA-ECMO) may be performed. In VA-ECMO, oxygen is added to the blood withdrawn from the vein by an artificial lung and then delivered to the artery.

[0006] Especially in VA-ECMO implemented at the emergency site, the maximum purpose is to deliver oxygen to the brain, and it is important to quickly circulate blood in the body and ensure the required blood volume. In the guidelines, when applying VA-ECMO, the required blood circulation volume is 3 L / min ２ / min (100 ml / kg / min for infants, 80 ml / kg / min for children, and 60 ml / kg / min for adults).

[0007] However, due to factors such as the patient's condition or inadequate preparation of equipment and devices, it may not be possible to achieve the desired ideal blood flow rate. Specific examples of inadequate equipment and devices include selecting the wrong blood circuit or a percutaneous catheter of the appropriate size.

[0008] The present invention was made to solve the above problems, and aims to provide an extracorporeal circulation device, an extracorporeal circulation system, and a control method for an extracorporeal circulation device that can ensure an ideal blood flow rate for the patient when performing VA-ECMO.

[0009] The above objectives of the present invention are achieved by the following means.

[0010] (1) An extracorporeal circulation device comprising: a blood circuit for circulating the patient's blood; a circulating pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure within the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate within the blood circuit; and a control unit, wherein the control unit comprises: a calculation unit for calculating the ideal flow rate and head pressure from patient-specific information; and a transmission unit for transmitting a signal to an infusion device for performing infusion when the data on the amount of water measured by a measuring device for measuring the amount of water in the patient is lower than the ideal amount of water; and the transmission unit transmits an infusion instruction to the infusion device via the transmission unit based on the data on the pressure in the blood circuit measured by the pressure measuring unit, the flow rate in the blood circuit measured by the flow rate measuring unit, and the amount of water measured by the measuring device.

[0011] (2) The extracorporeal circulation apparatus according to (1), wherein the control unit further has a storage unit for storing various initial parameters and standard values.

[0012] (3) The extracorporeal circulation apparatus according to (1) or (2), wherein the control unit further comprises an alarm unit that issues an alert when the rotational speed of the drive motor that drives the circulation pump is not a desired value.

[0013] (4) The extracorporeal circulation device according to any one of (1) to (3), wherein the control unit further has an alarm unit that issues an alert when the patient's fluid volume is not at a desired value.

[0014] (5) An extracorporeal circulation system comprising: a blood circuit for circulating the patient's blood; a circulating pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure within the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate within the blood circuit; a control unit; a fluid replacement device for providing fluids to the patient; and a measuring device for measuring the patient's fluid content, wherein the control unit has a calculation unit that calculates ideal flow rates and head pressure from patient-specific information, and the control unit issues a fluid replacement instruction to the fluid replacement device based on data of the pressure in the blood circuit measured by the pressure measuring unit, the flow rate in the blood circuit measured by the flow rate measuring unit, and the fluid content measured by the measuring device.

[0015] (6) A control method for an extracorporeal circulation device having: a blood circuit for circulating a patient's blood; a circulation pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure in the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate in the blood circuit; and a control unit, the control method comprising: a step of the pressure measuring unit acquiring data on the pressure in the blood circuit; a step of the flow rate measuring unit acquiring data on the flow rate in the blood circuit; a step of the control unit acquiring data on the patient's fluid volume from a measuring device for measuring the patient's fluid volume; a step of the control unit determining whether or not to perform fluid replacement on the patient based on the acquired data on the pressure, flow rate, and fluid volume; and, if it is determined that to perform fluid replacement on the patient, a step of the control unit sending an instruction to perform fluid replacement on a fluid replacement device to perform the fluid replacement on the patient.

[0016] (7) The control method according to (6), further comprising the steps of: calculating an ideal head pressure from the patient's unique information; and comparing the measured head pressure calculated from the pressure measuring unit with the ideal head pressure.

[0017] (8) The control method according to (7), further comprising the step of confirming the measured flow rate when the measured head pressure is equal to or greater than the ideal head pressure.

[0018] (9) The control method according to (8), further comprising the step of calculating an ideal flow rate based on the ideal head pressure, and further comprising the step of confirming the amount of fluid in the patient if the measured flow rate is lower than the ideal flow rate.

[0019] (10) The control method according to any one of (6) to (9), further comprising the step of performing fluid replacement if the patient's fluid volume is lower than the ideal fluid volume.

[0020] (11) The control method according to any one of (7) to (10), further comprising the step of issuing an alert to change the rotation speed of the circulation pump when the measured head pressure is lower than the ideal head pressure.

[0021] (12) The control method according to (9) or (10), further comprising the step of triggering an alert to change the position or size of the percutaneous catheter if the amount of fluid in the patient is equal to or greater than the ideal amount of fluid.

[0022] According to the extracorporeal circulation device, extracorporeal circulation system, and control method for the extracorporeal circulation device configured as described above, the fluid replacement device is instructed to replace fluids based on data of the pressure in the blood circuit measured by the pressure measuring unit, the flow rate in the blood circuit measured by the flow rate measuring unit, and the amount of fluid measured by the measuring device. In patients whose hearts are not functioning properly, blood pressure is significantly lower, causing vasoconstriction and making it difficult to ensure blood flow. With the above configuration, when the amount of fluid is lower than the standard amount of fluid, the fluid replacement device replaces fluids, thereby dilating the blood vessels and ensuring blood flow. Therefore, it is possible to provide an extracorporeal circulation device, extracorporeal circulation system, and control method for the extracorporeal circulation device that can ensure an ideal blood flow rate for the patient when performing VA-ECMO.

[0023] This is a system diagram showing an extracorporeal circulation system according to an embodiment of the present invention. This is a block diagram showing the control unit of the extracorporeal circulation system according to this embodiment. This is a graph showing the relationship between flow rate and head pressure in the blood circuit. This is a flowchart showing the control method of the extracorporeal circulation device according to this embodiment.

[0024] Embodiments of the present invention will be described below with reference to Figures 1 to 4. Note that the following description does not limit the technical scope or the meaning of terms described in the claims. Also, the dimensional ratios in the drawings are exaggerated for illustrative purposes and may differ from actual measurements.

[0025] Figure 1 is a diagram showing an extracorporeal circulation system 100 used as percutaneous cardiopulmonary support (PCPS) to temporarily assist and substitute for the functions of the heart and lungs when a patient's heart is weakened, until cardiac function recovers. Figure 2 is a block diagram showing the control unit 90 of the extracorporeal circulation system 100 according to this embodiment. Figure 3 is a graph showing the relationship between flow rate and head pressure in the blood circuit 20. Figure 4 is a flowchart showing the control method of the extracorporeal circulation device 1 according to this embodiment.

[0026] The extracorporeal circulation system 100 according to this embodiment can be used by appropriately switching between veno-arterial (VA) and veno-venous (VV) procedures. The veno-arterial (VA) procedure refers to a procedure in which blood is drawn from the patient's vein (e.g., the superior vena cava) by operating a pump, oxygenated by gas exchange in the blood using an artificial lung 10, and then returned to the patient's artery (e.g., the aorta). On the other hand, the veno-venous (VV) procedure refers to a procedure in which blood is drawn from the patient's vein (e.g., the superior vena cava) by operating a pump, oxygenated by gas exchange in the blood using an artificial lung 10, and then returned to the patient's vein (e.g., the superior vena cava). In this way, the extracorporeal circulation system 100 can be used as a device to assist the patient's heart and lungs. Hereinafter, the procedure of drawing blood from a patient, performing prescribed procedures outside the body, and then returning the blood to the patient's body will be referred to as "extracorporeal circulation."

[0027] As shown in Figure 1, the extracorporeal circulation system 100 includes an extracorporeal circulation device 1, a fluid replacement device 70 for providing fluids to the patient, and a measuring device 80 for measuring the patient's fluid volume.

[0028] As shown in Figure 1, the extracorporeal circulation device 1 includes an artificial lung 10, a blood circuit 20 consisting of a blood withdrawal circuit 21 and a blood delivery circuit 22, a circulation pump 30, a drive motor 31 for driving the circulation pump 30, a blood withdrawal tube (percutaneous catheter) 41 connected to the blood withdrawal circuit 21, a blood delivery tube (percutaneous catheter) 42 connected to the blood delivery circuit 22, a first pressure measuring unit 45 provided in the blood circuit 20 between the blood withdrawal tube 41 and the circulation pump 30 for measuring the pressure within the blood circuit 20, a second pressure measuring unit 46 provided in the blood circuit 20 between the circulation pump 30 and the artificial lung 10 (connecting circuit 23 described later) for measuring the pressure within the blood circuit 20, a flow rate measuring unit 47 provided in the blood circuit 20 between the artificial lung 10 and the blood delivery tube 42 for measuring the flow rate of blood within the blood circuit 20, and a control unit 90.

[0029] The artificial lung 10 is positioned between the circulation pump 30 and the flow rate measuring unit 47. The artificial lung 10 performs gas exchange with the blood (oxygenation and / or carbon dioxide removal). The artificial lung 10 is, for example, a membrane oxygenator, but a hollow fiber membrane oxygenator can be used in particular.

[0030] As shown in Figure 1, the blood circuit 20 includes a blood withdrawal circuit 21, a blood supply circuit 22, and a connecting circuit 23. One end of the blood withdrawal circuit 21 is connected to a blood withdrawal tube 41. The blood withdrawal tube 41 is inserted through the femoral vein and its tip is placed in the right atrium via the inferior vena cava. The other end of the blood withdrawal circuit 21 is connected to a circulating pump 30. In the blood withdrawal circuit 21, blood flows in the direction of V1.

[0031] One end of the blood supply circuit 22 is connected to the blood supply tube 42. The blood supply tube 42 is inserted into the femoral artery. The other end of the blood supply circuit 22 is connected to the artificial lung 10. In the blood supply circuit 22, blood flows in the direction of V2.

[0032] The connecting circuit 23 is positioned between the circulating pump 30 and the artificial lung 10. The connecting circuit 23 is configured to connect the blood withdrawal circuit 21 and the blood supply circuit 22.

[0033] As the tubes constituting the blood circuit 20, for example, tubing made of highly transparent, elastically deformable, and flexible synthetic resins such as polyvinyl chloride resin or silicone rubber can be used.

[0034] When the drive motor 31 operates the circulation pump 30 in accordance with the command from the control unit 90, the circulation pump 30 can draw blood from the blood withdrawal circuit 21, pass the blood through the artificial lung 10, and then return the blood to the patient P via the blood supply circuit 22.

[0035] The first pressure measuring unit (pressure measuring unit) 45 is provided on the blood withdrawal circuit 21. When extracorporeal circulation is being performed on patient P by the extracorporeal circulation system 100, the pressure inside the blood withdrawal circuit 21 can be measured by the first pressure measuring unit 45.

[0036] The second pressure measuring unit (pressure measuring unit) 46 is provided on the connecting circuit 23. When extracorporeal circulation is being performed on patient P by the extracorporeal circulation system 100, the second pressure measuring unit 46 can measure the pressure inside the connecting circuit 23.

[0037] The flow rate measuring unit 47 is provided on the blood delivery circuit 22. When extracorporeal circulation is being performed on patient P by the extracorporeal circulation system 100, the flow rate of blood in the connecting circuit 23 can be measured by the second pressure measuring unit 46.

[0038] The fluid replacement device 70 provides fluid replacement to the blood vessels of patient P when the patient's fluid volume is low. Examples of fluids that can be replaced by the fluid replacement device 70 include extracorporeal circulation perfusion fluid. Specifically, for example, physiological saline (Terumo Saline, manufactured by Terumo Corporation) and Ringer's solution (Solulact Infusion®, manufactured by Terumo Corporation) can be used.

[0039] The fluid replacement device 70 is connected to a tube 71, which is connected to a blood vessel of patient P.

[0040] When the extracorporeal circulation system 100 is in operation, the measuring device 80 measures the amount of water in the patient. As the measuring device 80, a known water content measuring device can be used. The amount of water in the patient can be measured, for example, by measuring the bioimpedance of the body.

[0041] The control unit 90 can be constituted by a microcomputer or the like. The control unit 90 includes a CPU, a ROM that stores the control program for the entire device and various data executed by the CPU, and a RAM that temporarily stores measurement data and various data as a work area.

[0042] As shown in FIG. 1, the control unit 90 is electrically connected to the drive motor 31, the first pressure measurement unit 45, the second pressure measurement unit 46, the flow rate measurement unit 47, the liquid replenishing device 70, the measuring device 80, and the like.

[0043] As shown in FIG. 2, the control unit 90 includes a calculation unit 91, a transmission unit 92, a storage unit 93, an alarm unit 94, and an image display unit 95.

[0044] The calculation unit 91 can calculate the ideal flow rate and the ideal head pressure from the patient-specific information. Here, the patient-specific information includes the patient's height and weight.

[0045] When the data of the amount of water in the patient measured by the measuring device 80 is lower than the ideal amount of water, the transmission unit 92 transmits a drive signal to the liquid replenishing device 70. When this drive signal is transmitted to the liquid replenishing device 70, the liquid replenishing device 70 is driven to perform a liquid replenishing operation.

[0046] The storage unit 93 can store the initial parameters and standard values. The contents stored in the storage unit 93 include the formula for calculating the ideal flow rate and the ideal head pressure from the patient-specific information, the relationship between the blood flow rate and the head pressure shown in FIG. 3, the numerical value of the ideal amount of water, the desired rotational speed of the drive motor 31 that drives the circulation pump 30, and the like.

[0047] The alarm unit 94 issues an alert if the rotation speed of the circulation pump 30 is not at a desired value or if the patient's fluid volume is not at a desired value. Methods of issuing the alert include, for example, displaying text on the image display unit 95 or using sound. If the patient's fluid volume is not at a desired value, an alert is issued prompting a change in the catheter's position or size.

[0048] Next, with reference to Figure 4, the control method of the extracorporeal circulation system 100 according to this embodiment will be described.

[0049] First, the calculation unit 91 calculates the ideal blood flow rate from the patient's height and weight (step S01). Specifically, it calculates the ideal blood flow rate per unit body surface area (1 m²) in a predetermined time (1 minute). ２ ) Flow rate of 3L per unit (3L / min ２ A blood flow rate of 60 ml / kg / min is considered ideal, and the ideal blood flow rate is calculated based on data such as 60 ml / kg / min for adults, 100 ml / kg / min for infants, and 80 ml / kg / min for children. For example, for a 60 kg adult, the ideal flow rate would be 3600 ml.

[0050] Next, the calculation unit 91 calculates the ideal head pressure from the ideal blood flow rate calculated in step S01 and the rotational speed of the drive motor 31 (step S02). Specifically, the ideal head pressure is calculated by referring to the graph in Figure 3.

[0051] Next, the calculation unit 91 calculates the measured head pressure from the two pressure values ​​before and after the circulation pump 30 (step S03). Specifically, the measured head pressure is calculated based on the difference (P2-P1) between the pressure P1 measured by the first pressure measuring unit 45 and the pressure P2 measured by the second pressure measuring unit 46.

[0052] Next, the control unit 90 determines whether the measured head pressure calculated in step S03 is lower than the ideal head pressure calculated in step S02 (step S04). If the measured head pressure is lower than the ideal head pressure (step S04: YES), the rotation speed of the drive motor 31 is checked (step S05). At this time, if it is determined that the head pressure is insufficient for the ideal blood flow rate, the alarm unit 94 issues an alarm to increase the rotation speed of the drive motor 31 in order to bring the head pressure to the desired value.

[0053] On the other hand, if the measured head pressure is greater than or equal to the ideal head pressure (step S04: NO), it is determined that the head pressure has been reached to produce the ideal flow rate, and the process proceeds to step S06.

[0054] In step S06, the control unit 90 determines whether the measured blood flow rate measured by the flow rate measuring unit 47 is close to the ideal blood flow rate (S06). If the measured blood flow rate is close to the ideal blood flow rate (step S06: YES), it determines that the blood circulation system is operating optimally, and returns to step S04 for continued monitoring. Here, "the measured blood flow rate is close to the ideal blood flow rate" means, for example, that the measured blood flow rate is within a numerical range of ±10% of the ideal blood flow rate.

[0055] On the other hand, if the measured blood flow rate deviates from the ideal blood flow rate (step S06: NO), the process proceeds to step S07.

[0056] In step S07, the control unit 90 determines whether the measured blood flow rate is higher than the ideal blood flow rate (step S07). If the measured blood flow rate is higher than the ideal blood flow rate (step S07: YES), the rotation speed of the drive motor 31 is checked (step S05). At this time, if the head pressure is determined to be too high for the ideal blood flow rate, the alarm unit 94 issues an alarm to reduce the rotation speed of the drive motor 31 so that the head pressure is set to the desired value. By including such a step S07, the risk of hemolysis occurring due to excessive head pressure or pressure in front of the circulation pump 30 can be reduced.

[0057] On the other hand, if the measured blood flow rate is lower than the ideal blood flow rate (step S07: NO), it is determined that there is a possibility that blood pressure is low and the blood vessels are narrowed, and the system proceeds to step S08.

[0058] In step S08, the control unit 90 determines whether the measured water content measured by the measuring device 80 is close to the ideal water content. If the measured water content is close to the ideal water content (it is known that water content changes with age, and this is set in advance taking age into consideration; for example, for a typical adult, it is 60% of body weight) (step S08: YES), the process returns to step S06. Here, "the measured water content is close to the ideal water content" means, for example, that the measured water content is within a numerical range of ±10% of the ideal water content.

[0059] On the other hand, if the measured moisture content is far from the ideal moisture content (step S08: NO), the process proceeds to step S09.

[0060] In step S09, the control unit 90 determines whether the measured moisture content measured by the measuring device 80 is higher than the ideal moisture content. If the measured moisture content is greater than or equal to the ideal moisture content (step S09: YES), the position or size of the percutaneous catheter may be undesirable, and the alarm unit 94 issues an alarm (step S10) instructing the user to change the position or size of the percutaneous catheter.

[0061] On the other hand, if the measured fluid volume is less than the ideal fluid volume (step S09: NO), it is determined that the patient's blood pressure is significantly lower because the heart is not functioning properly, causing vasoconstriction and making it difficult to maintain blood flow. Therefore, fluid is administered to the patient by the fluid replacement device 70 (step S11). As a result, the patient's blood vessels can be dilated and blood flow can be maintained. After step S11 is performed, the process returns to step S06 to check the flow rate. This prevents edema and swelling caused by excessive fluid replacement. This process is repeated until extracorporeal circulation is completed. If the measured fluid volume is within the range of the ideal fluid volume, the process returns to step S06 to check the flow rate.

[0062] Then, once extracorporeal circulation is complete, the blood withdrawal tube 41 and blood return tube 42 are removed from the blood vessel, and the insertion site is surgically repaired to stop bleeding as needed.

[0063] As described above, the extracorporeal circulation device 1 according to this embodiment includes a blood circuit 20 for circulating the patient's blood, a circulation pump 30 for circulating the blood in the blood circuit 20, pressure measuring units 45 and 46 provided in the blood circuit 20 for measuring the pressure within the blood circuit 20, a flow rate measuring unit 47 provided in the blood circuit 20 for measuring the flow rate within the blood circuit 20, and a control unit 90. The control unit 90 includes a calculation unit 91 that calculates the ideal flow rate and head pressure from patient-specific information, and a transmission unit 92 that transmits a drive signal to a fluid replacement device 70 that performs fluid replacement when the data on the amount of fluid measured by a measuring device 80 that measures the amount of fluid in the patient is lower than the ideal amount of fluid. Based on the pressure in the blood circuit 20 measured by the pressure measuring units 45 and 46, the flow rate in the blood circuit 20 measured by the flow rate measuring unit 47, and the data on the amount of fluid measured by the measuring device 80, the transmission unit 92 sends a fluid replacement instruction to the fluid replacement device 70. With the extracorporeal circulation device 1 configured in this way, the device issues a fluid replacement command to the fluid replacement device 70 based on the pressure in the blood circuit 20 measured by the pressure measuring units 45 and 46, the flow rate in the blood circuit 20 measured by the flow rate measuring unit 47, and the fluid volume measured by the measuring device 80. In patients whose hearts are not functioning properly, blood pressure is significantly lower, causing vasoconstriction and making it difficult to secure blood flow. With the above configuration, when the fluid volume is lower than the standard fluid volume, the fluid replacement device 70 provides fluid replacement, which dilates the blood vessels and secures blood flow. Therefore, when performing VA-ECMO, an ideal blood flow rate can be secured for the patient.

[0064] Furthermore, as described above, the extracorporeal circulation system 100 according to this embodiment includes a blood circuit 20 for circulating the patient's blood, a circulation pump 30 for circulating the blood in the blood circuit 20, pressure measuring units 45 and 46 provided in the blood circuit 20 for measuring the pressure within the blood circuit 20, a flow rate measuring unit 47 provided in the blood circuit 20 for measuring the flow rate within the blood circuit 20, a control unit 90, a fluid replacement device 70 for providing fluids to the patient, and a measuring device 80 for measuring the patient's fluid content. The control unit 90 has a calculation unit 91 that calculates the ideal flow rate and head pressure from patient-specific information, and issues a fluid replacement instruction to the fluid replacement device 70 based on the pressure within the blood circuit 20 measured by the pressure measuring units 45 and 46, the flow rate within the blood circuit 20 measured by the flow rate measuring unit 47, and the fluid content measured by the measuring device 80. With the extracorporeal circulation system 100 configured in this way, the system issues a fluid replacement command to the fluid replacement device 70 based on the pressure in the blood circuit 20 measured by the pressure measuring units 45 and 46, the flow rate in the blood circuit 20 measured by the flow rate measuring unit 47, and the fluid volume measured by the measuring device 80. In patients whose hearts are not functioning properly, blood pressure is significantly lower, causing vasoconstriction and making it difficult to ensure blood flow. With the above configuration, when the fluid volume is lower than the standard fluid volume, the fluid replacement device 70 performs fluid replacement, thereby dilating the blood vessels and ensuring blood flow. Therefore, when performing VA-ECMO, it is possible to ensure an ideal blood flow rate for the patient.

[0065] Furthermore, as described above, the control method for the extracorporeal circulation device 1 according to this embodiment is a control method for the extracorporeal circulation device 1 having a blood circuit 20 for circulating the patient's blood, a circulation pump 30 for circulating the blood in the blood circuit 20, pressure measuring units 45 and 46 provided in the blood circuit 20 for measuring the pressure in the blood circuit 20, a flow rate measuring unit 47 provided in the blood circuit 20 for measuring the flow rate in the blood circuit 20, and a control unit 90. The control method includes the steps of: the pressure measuring units 45 and 46 acquiring data on the pressure in the blood circuit 20; the flow rate measuring unit 47 acquiring data on the flow rate in the blood circuit 20; the control unit 90 acquiring data on the patient's fluid volume from a measuring device 80 for measuring the patient's fluid volume; the control unit 90 determining whether or not to perform fluid replacement on the patient based on the acquired pressure, flow rate, and fluid volume data; and, if it is determined that fluid replacement should be performed on the patient, the control unit 90 sending a fluid replacement instruction to a fluid replacement device 70 that performs fluid replacement on the patient. According to this control method, the fluid replacement device 70 is instructed to replace fluids based on the pressure in the blood circuit 20 measured by the pressure measuring units 45 and 46, the flow rate in the blood circuit 20 measured by the flow rate measuring unit 47, and the amount of fluid measured by the measuring device 80. In patients whose hearts are not functioning properly, blood pressure is significantly lower, causing vasoconstriction and making it difficult to ensure blood flow. With the above configuration, when the amount of fluid is lower than the standard amount, the fluid replacement device 70 replaces fluids, thereby dilating the blood vessels and ensuring blood flow. Therefore, when performing VA-ECMO, an ideal blood flow rate can be ensured for the patient.

[0066] Although the extracorporeal circulation device 1, extracorporeal circulation system 100, and control method according to the present invention have been described above through embodiments, the present invention is not limited to the configuration described in the embodiments and can be modified as appropriate based on the claims.

[0067] For example, in the embodiment described above, after the fluid replenishment by the fluid replenishment device 70 (step S11) was performed, the process returned to step S06 to confirm the flow rate. However, after the fluid replenishment by the fluid replenishment device 70 (step S11) was performed, the process may return to step S04 to compare the measured head pressure with the ideal head pressure.

[0068] Furthermore, in the embodiment described above, the extracorporeal circulation device 1 had an alarm unit 94, but it does not have to have an alarm unit 94.

[0069] This application is based on Japanese Patent Application No. 2024-166055, filed on 25 September 2024, the disclosures of which are cited in their entirety by reference.

[0070] 1 Extracorporeal circulation device, 10 Artificial lung, 20 Blood circuit, 30 Circulation pump, 31 Drive motor, 45 First pressure measuring unit, 46 Second pressure measuring unit, 47 Flow rate measuring unit, 70 Fluid replacement device, 80 Measuring device, 90 Control unit, 91 Calculation unit, 92 Transmission unit, 93 Storage unit, 94 Alarm unit, 100 Extracorporeal circulation system.

Claims

1. An extracorporeal circulation device comprising: a blood circuit for circulating the patient's blood; a circulating pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure within the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate within the blood circuit; and a control unit, wherein the control unit comprises: a calculation unit for calculating the ideal flow rate and head pressure from patient-specific information; and a transmission unit for transmitting a signal to a fluid replacement device to perform fluid replacement when the data of the amount of water measured by a measuring device for measuring the amount of water of the patient is lower than the ideal amount of water; and the transmission unit provides a fluid replacement instruction to the fluid replacement device via the transmission unit based on the data of the pressure in the blood circuit measured by the pressure measuring unit, the flow rate in the blood circuit measured by the flow rate measuring unit, and the amount of water measured by the measuring device.

2. The extracorporeal circulation apparatus according to claim 1, wherein the control unit further comprises a storage unit for storing various initial parameters and standard values.

3. The extracorporeal circulation device according to claim 1 or 2, wherein the control unit further comprises an alarm unit that issues an alert when the rotational speed of the drive motor that drives the circulation pump is not a desired value.

4. The extracorporeal circulation device according to claim 1 or 2, wherein the control unit further comprises an alarm unit that issues an alert when the patient's fluid volume is not at a desired value.

5. An extracorporeal circulation system comprising: a blood circuit for circulating the patient's blood; a circulating pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure within the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate within the blood circuit; a control unit; a fluid replacement device for providing fluids to the patient; and a measuring device for measuring the patient's fluid content, wherein the control unit has a calculation unit that calculates ideal flow rates and head pressure from patient-specific information, and the control unit issues a fluid replacement instruction to the fluid replacement device based on data of the pressure in the blood circuit measured by the pressure measuring unit, the flow rate in the blood circuit measured by the flow rate measuring unit, and the fluid content measured by the measuring device.

6. A control method for an extracorporeal circulation device having: a blood circuit for circulating a patient's blood; a circulation pump for circulating the blood in the blood circuit; a pressure measuring unit provided in the blood circuit for measuring the pressure in the blood circuit; a flow rate measuring unit provided in the blood circuit for measuring the flow rate in the blood circuit; and a control unit, the control method comprising: a step of the pressure measuring unit acquiring data on the pressure in the blood circuit; a step of the flow rate measuring unit acquiring data on the flow rate in the blood circuit; a step of the control unit acquiring data on the patient's fluid volume from a measuring device for measuring the patient's fluid volume; a step of the control unit determining whether or not to perform fluid replacement on the patient based on the acquired data on pressure, flow rate, and fluid volume; and, if it is determined that the patient should receive the fluid replacement, the control unit sending an instruction to a fluid replacement device to perform the fluid replacement on the patient.

7. The control method according to claim 6, further comprising the steps of: calculating an ideal head pressure from the patient's unique information; and comparing the measured head pressure calculated from the pressure data of the pressure measuring unit with the ideal head pressure.

8. The control method according to claim 7, further comprising the step of confirming the measured flow rate when the measured head pressure is equal to or greater than the ideal head pressure.

9. The control method according to claim 8, further comprising the step of calculating an ideal flow rate based on the ideal head pressure, and further comprising the step of confirming the amount of fluid in the patient if the measured flow rate is lower than the ideal flow rate.

10. The control method according to claim 9, further comprising the step of performing fluid replacement if the patient's fluid volume is lower than the ideal fluid volume.

11. The control method according to claim 7 or 8, further comprising the step of issuing an alert to change the rotational speed of the circulation pump when the measured head pressure is lower than the ideal head pressure.

12. The control method according to claim 9 or 10, further comprising the step of triggering an alert to change the position or size of the percutaneous catheter if the patient's fluid volume is greater than or equal to the ideal fluid volume.

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