Blood purification system, control method, control program, learning device and learning method

Abstract

Provided are a blood purification system and the like, capable of more appropriately carrying out blood purification. The blood purification system comprises: a line through which a liquid including blood or filtrate flows; a blood purification device that purifies the blood flowing through the line; a feeder that feeds a dialysate or replacement fluid to the line; a detecting unit that detects blood information relating to the blood flowing through the line; a liquid controlling mechanism that controls the flow of the liquid within the line on the basis of a controlling parameter; a parameter acquiring unit that inputs, into a learning model having been trained to output a predetermined controlling parameter when a predetermined piece of blood information is input thereinto, the detected blood information and acquires the controlling parameter output from the learning model; and a controlling unit that controls the liquid controlling mechanism on the basis of the acquired controlling parameter.

Description

[Technical Field]

[0001] The present disclosure relates to a blood purification system, a control method, a control program, a learning device, and a learning method. [Background technology]

[0002] Multiple blood purification systems used in dialysis and other procedures are installed in dialysis rooms within medical facilities such as hospitals, and are configured to perform blood purification on a large number of patients within the dialysis rooms. A server (central control means) is installed within each dialysis room to store patient management data related to blood purification (such as the patient's weight and blood pressure), and this management data is transmitted to and displayed on each individual blood purification system.

[0003] For example, when a patient undergoes dialysis, their weight and blood pressure before dialysis are measured using a scale and a blood pressure monitor, and these are sent to the central control means and stored as the patient's unique information. Based on this unique patient information, the central control means calculates the patient's conditions using a predetermined calculation formula, and transmits the calculated conditions to the blood purification system, thereby performing optimal blood purification for each patient.

[0004] For example, Patent Document 1 discloses a blood purification system in which multiple monitoring devices are installed in a dialysis room in a medical facility such as a hospital. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Japanese Patent Application Laid-Open No. 2012-249748 Summary of the Invention

[0006] There is a demand for blood purification systems to perform blood purification more appropriately.

[0007] The purpose of the blood purification system, control method, control program, learning device, and learning method is to enable more appropriate blood purification.

[0008] A blood purification system according to an embodiment includes a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplier that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, a liquid control mechanism that controls the flow of liquid in the line based on control parameters, a parameter acquisition unit that inputs the blood information detected by the detection unit into a learning model that has been trained to output predetermined control parameters when the predetermined blood information is input, and acquires the control parameters output from the learning model, and a controller that controls the liquid control mechanism based on the control parameters acquired by the parameter acquisition unit. The blood information includes at least one of the following: degree of blood turbulence, blood vorticity, degree of cardiac murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0009] In the blood purification system according to the embodiment, the learning model has an action value function in which blood information is the state and control based on control parameters is the action, and the action value function is preferably updated based on a reward that is set to increase as the change in blood information decreases.

[0010] In the blood purification system according to the embodiment, the liquid control mechanism includes a magnetic force regulator that applies a magnetic field to the blood in a predetermined direction, a pump that controls the flow of liquid in the line, or a resistance applying member that applies resistance to the line, and the control parameters preferably include at least one of the strength of the magnetic field applied by the magnetic force regulator, the amount of drive of the pump, and the magnitude of the resistance applied by the resistance applying member.

[0011] In the blood purification system according to the embodiment, it is preferable to further include a memory unit that stores the learning model in association with product data of the plasma separation device, data on the blood flowing through the line, clearance data by the blood purification system, the amount of causative substance removed, or antithrombotic properties.

[0012] In the blood purification system according to the embodiment, it is preferable to further include a generation unit that generates a learning model based on the blood information detected by the detection unit before and after controlling the liquid control mechanism based on specific control parameters, and the specific control parameters.

[0013] In the blood purification system according to the embodiment, the blood purification system is preferably an extracorporeal circulation blood purification system.

[0014] In the blood purification system according to the embodiment, the blood purification system preferably performs continuous hemodiafiltration, continuous hemofiltration, continuous hemodialysis, or apheresis.

[0015] A control method according to an embodiment is a control method for a blood purification system having a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplier that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, and a liquid control mechanism that controls the flow of the liquid in the line based on control parameters. The control method includes inputting the blood information detected by the detection unit into a learning model that has been trained to output predetermined control parameters when predetermined blood information is input, acquiring the control parameters output from the learning model, and controlling the liquid control mechanism based on the acquired control parameters. The blood information includes at least one of the following: degree of blood turbulence, blood vorticity, degree of cardiac murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0016] The control program according to the embodiment is a control program for a computer included in a blood purification system having a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplier that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, and a liquid control mechanism that controls the flow of the liquid in the line based on control parameters. The control program causes the computer to input the blood information detected by the detection unit into a learning model that has been trained to output predetermined control parameters when predetermined blood information is input, obtain the control parameters output from the learning model, and control the liquid control mechanism based on the obtained control parameters. The blood information includes at least one of the degree of blood turbulence, blood vorticity, degree of cardiac murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0017] A learning device according to an embodiment is provided for a blood purification system having a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplyer that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, and a liquid control mechanism that controls the flow of liquid in the line based on control parameters. The learning device includes: a data acquisition unit that acquires multiple combinations of blood information and control parameters; a generation unit that generates a learning model that has been trained to output predetermined control parameters when predetermined blood information is input using the combinations acquired by the data acquisition unit; and an output control unit that outputs information related to the learning model. The blood information includes at least one of the following: degree of blood turbulence, blood vorticity, degree of cardiac murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0018] In the learning device according to the embodiment, it is preferable that the learning device further includes a communication unit for communicating with a plurality of blood purification systems, and the data acquisition unit acquires the combinations by receiving them from the plurality of blood purification systems via the communication unit.

[0019] In the learning device of the embodiment, it is preferable that the data acquisition unit acquires the combination by controlling the liquid control mechanism based on specific control parameters and acquiring blood information detected by the detection unit before and after controlling the liquid control mechanism based on the specific control parameters.

[0020] A learning method according to an embodiment includes a computer acquiring multiple combinations of blood information and control parameters in a blood purification system having a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplier that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, and a liquid control mechanism that controls the flow of liquid in the line based on the control parameters, generating a learning model that has been trained to output predetermined control parameters when predetermined blood information is input using the acquired combinations, and outputting information about the learning model, wherein the blood information includes at least one of the degree of blood turbulence, blood vorticity, degree of heart murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0021] A control program according to an embodiment is a computer control program that causes a computer to acquire multiple combinations of blood information and control parameters in a blood purification system having a line through which a liquid containing blood or filtrate flows, a blood purification device that purifies the blood flowing in the line, a supplier that supplies dialysate or replacement fluid to the line, a detection unit that detects blood information related to the blood flowing in the line, and a liquid control mechanism that controls the flow of liquid in the line based on the control parameters, generate a learning model that has been trained to output predetermined control parameters when predetermined blood information is input using the acquired combinations, and output information related to the learning model, where the blood information includes at least one of the degree of blood turbulence, blood vorticity, degree of heart murmur, blood pressure, pressure loss of blood pressure, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, degree of hemolysis, and blood pressure of a patient connected to the line.

[0022] The blood purification system, control method, control program, learning device, and learning method can more appropriately perform blood purification.

[0023] The objects and advantages of the invention will be realized and obtained by means of the elements and combinations particularly pointed out in the claims. Both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the invention as claimed. [Brief explanation of the drawings]

[0024] [Figure 1] 1 is a diagram showing a schematic configuration of a management system 100 according to an embodiment. [Figure 2] FIG. 2 is a schematic diagram showing the blood purification unit 14. [Figure 3] FIG. 1 is a diagram showing a schematic configuration of a blood purification system 40. [Figure 4] FIG. 10 is a schematic diagram showing an example of the data structure of a result table 553. [Figure 5]FIG. 2 is a diagram showing a schematic configuration of a server 80. [Figure 6] 10 is a flowchart showing an example of the operation of a learning process of the control device 50. [Figure 7] 4 is a flowchart showing an example of the operation of a control process of the control device 50. [Figure 8] 10 is a flowchart showing an example of the operation of a learning process of the server 80. [Figure 9] FIG. 10 is a schematic diagram showing another blood purification unit 14-2. [Figure 10] FIG. 10 is a schematic diagram showing yet another blood purification unit 14-3. [Figure 11] FIG. 10 is a schematic diagram showing yet another blood purification unit 14-4. DETAILED DESCRIPTION OF THE INVENTION

[0025] Hereinafter, a blood purification system, a control method, a control program, a learning device, and a learning method according to one aspect of an embodiment will be described with reference to the drawings. However, it should be noted that the technical scope of the present invention is not limited to these embodiments, but extends to the inventions set forth in the claims and their equivalents.

[0026] FIG. 1 is a diagram showing a schematic configuration of a management system 100 according to an embodiment.

[0027] As shown in FIG. 1, the management system 100 includes one or more blood purification systems 40, a server 80, and other components. Each blood purification system 40 and the server 80 are communicably connected to each other via a network 70. Each blood purification system 40 is an extracorporeal circulation blood purification system. Each blood purification system 40 performs continuous hemodiafiltration (CHDF), continuous hemofiltration (CHF), continuous hemodialysis (CHD), or apheresis. Each blood purification system 40 includes a blood purification unit 14 and a control device 50. The network 70 is a wired network such as the Internet or an intranet. The network 70 may also be a wireless network such as a wireless local area network (LAN).

[0028] FIG. 2 is a schematic diagram showing the blood purification unit 14 included in the blood purification system 40. As shown in FIG.

[0029] As shown in FIG. 2 , the blood purification unit 14 includes the blood purification device 1, a blood supply line 3, a blood return line 4, a blood pump 5, a replacement fluid container 7, a filtrate line 8, a filtrate pump 9, a dialysate line 10, a dialysate pump 11, a replacement fluid line 12, a replacement fluid pump 13, a magnetic force regulator 16, a blood flow detector 17, a hematocrit detector 18, first pressure gauges 21-23, a second pressure gauge 25, a third pressure gauge 26, a fourth pressure gauge 27, first flow meters 28 and 29, a second flow meter 30, a third flow meter 31, a fourth flow meter 32, piping systems 33 and 33′, (three-way) valves 34 and 34′, and piping systems 35 and 35′. The blood purification unit 14 is used to utilize the blood purification device 1 in a clinical environment. The blood purification unit 14 performs continuous hemodiafiltration, continuous hemofiltration, continuous hemodialysis, or apheresis.

[0030] The blood supply line 3, the blood return line 4, the filtrate line 8, the dialysate line 10, the replacement fluid line 12, and the piping systems 33 and 33' are examples of lines through which a liquid containing blood or filtrate flows, and constitute a blood circuit. For example, polyvinyl chloride tubing is used for the blood supply line 3, the blood return line 4, the filtrate line 8, the dialysate line 10, the replacement fluid line 12, and the piping systems 33 and 33'. For example, tubing having a length and diameter such that the total volume of the liquid contained therein is approximately 150 ml is used for the blood supply line 3 and the blood return line 4. Other materials may also be used for the blood supply line 3, the blood return line 4, the filtrate line 8, the dialysate line 10, the replacement fluid line 12, and the piping systems 33 and 33'.

[0031] The piping system 33 is a blood circuit and has a blood collection section 33a from a patient (animal or human). The piping system 33' is a blood circuit and has a blood return section 33b to the patient. The blood transfer line 3 sends blood withdrawn from the blood collection section 33a to the blood purification device 1 via a blood pump 5. The blood return line 4 sends blood flowing out of the blood purification device 1 to the blood return section 33b. The filtrate line 8 is connected to the dialysate outlet 1b of the blood purification device 1 and sends the liquid, replacement fluid, and / or dialysate containing waste products flowing out from the dialysate outlet 1b to the outside of the device as filtrate via a filtrate pump 9. The dialysate line 10 is connected to a replacement fluid container 7 and a dialysate inlet 1a of the blood purification device 1 and sends the dialysate flowing out of the replacement fluid container 7 to the dialysate inlet 1a via a dialysate pump 11. The fluid replacement line 12 is connected to the fluid replacement container 7, the blood supply line 3, and / or the blood return line 4, and sends the fluid replacement flowing out from the fluid replacement container 7 to the blood supply line 3 and / or the blood return line 4 via the fluid replacement pump 13. The transfer of the fluid replacement to the blood supply line 3 and / or the blood return line 4 via the fluid replacement pump 13 can be achieved by, for example, a three-way valve (not shown).

[0032] The blood purification device 1 purifies blood flowing through each line of the blood purification unit 14. In particular, the blood purification device 1 is a blood filter that performs continuous slow blood filtration. The blood purification device 1 may be a hemodialyzer or the like. The blood purification device 1 separates waste products and the like from blood during blood filtration, dialysis, or the like. The blood purification device 1 has a dialysate inlet 1a, a dialysate outlet 1b, an inlet port 1c, an outlet port 1d, and a hollow membrane body 1e. The inlet port 1c is an inlet for blood withdrawn from a patient and / or replacement fluid supplied from a replacement fluid container 7. The hollow membrane body 1e is composed of a bundle of multiple hollow fiber membranes through which the blood and / or replacement fluid flowing in from the inlet port 1c passes. The outlet port 1d is an outlet for the blood and / or replacement fluid that has passed through the hollow membrane body 1e and flows out of the device. The dialysate inlet 1a is an inlet for the dialysate to flow into the hollow membrane body 1e. The dialysate outlet 1b is a purification port, and is an outlet for liquid containing waste products and / or replacement fluid that has permeated to the outside of the hollow membrane body 1e, and / or an outlet for dialysate that passes through the outside of the hollow membrane body 1e. A known general blood purification device can be used as the blood purification device 1.

[0033] The replacement fluid container 7 supplies dialysate to the blood purification device 1 by supplying dialysate to the dialysate line 10, and / or supplies replacement fluid to the blood feed line 3 and the blood return line 4 by supplying replacement fluid to the replacement fluid line 12. A known, general replacement fluid container can be used as the replacement fluid container 7. By providing the replacement fluid container 7, the blood purification unit 14 can filter and / or remove water from the liquid (blood) in the line using the blood purification device 1. If the liquid volume in the replacement fluid container 7 is less than 100 mL, the liquid volume in the replacement fluid container 7 may be insufficient during operation of the blood purification unit 14, making it difficult to circulate the liquid. Therefore, it is preferable that the liquid volume in the replacement fluid container 7 be 100 mL or more. Note that a dialysate supplying device capable of constantly supplying dialysate and / or replacement fluid may be used instead of the replacement fluid container 7. The replacement fluid container 7 and the dialysate supplying device are examples of a supplying device.

[0034] The blood pump 5 is provided in the blood supply line 3 and controls the flow of blood in the blood supply line 3. The filtrate pump 9 is provided in the filtrate line 8 and controls the flow of filtrate in the filtrate line 8. The dialysate pump 11 is provided in the dialysate line 10 and controls the flow of dialysate in the dialysate line 10. The replacement fluid pump 13 is provided in the replacement fluid line 12 and controls the flow of replacement fluid in the replacement fluid line 12. The blood pump 5, the filtrate pump 9, the dialysate pump 11, and the replacement fluid pump 13 are each provided so that their driving amount (output amount) can be changed under the control of the control device 50. The blood pump 5, the filtrate pump 9, the dialysate pump 11, and the replacement fluid pump 13 are, for example, roller pumps. Other known pumps may also be used as the blood pump 5, the filtrate pump 9, the dialysate pump 11, and the replacement fluid pump 13.

[0035] The magnetic force regulator 16 is provided to surround a predetermined position on the blood purification device 1 and applies a magnetic field in a predetermined direction to the blood in the blood purification device 1. The magnetic force regulator 16 may also be provided to surround a predetermined position on the patient's body connected to the blood transfer line 3, the blood return line 4, or the blood purification unit 14 and apply a magnetic field in a predetermined direction to the blood transfer line 3, the blood return line 4, or the blood in the patient's body. The magnetic force regulator 16 has an annular magnet and applies a unidirectional magnetic field parallel to or opposite to the direction of blood flow within the region inside the annular magnet. The magnetic force regulator 16 is provided to be able to change the strength of the applied magnetic field under the control of the control device 50. The strength of the magnetic field is set to a strength sufficient to reduce the viscosity of the blood by a predetermined amount and / or suppress turbulence in the blood flow by a predetermined amount at the position where the magnetic field is applied. For example, an electromagnet, a permanent magnet, or a superconducting magnet may be used as the magnetic force regulator 16.

[0036] The magnetic force regulator 16 can suppress clogging of blood cell components in the blood purification device 1, suppress pressure increases in the blood purification device 1, and reduce blood viscosity and blood turbulence. This allows the blood purification unit 14 to lower the patient's blood pressure, improve hypertension, and reduce the occurrence of heart murmurs. If the strength of the unidirectional magnetic field of the magnetic force regulator 16 is less than 0.01 Tesla, the magnetic effect on red blood cells is low. On the other hand, a magnetic force regulator 16 exceeding 100 Tesla tends to be difficult to handle and expensive. Therefore, the strength of the unidirectional magnetic field of the magnetic force regulator 16 is preferably 0.01 Tesla or more and 100 Tesla or less, and more preferably 1 Tesla or more and 10 Tesla or less.

[0037] The blood pump 5, the filtrate pump 9, the dialysate pump 11, the replacement fluid pump 13, and the magnetic force regulator 16 are an example of a fluid control mechanism that controls the flow of fluid in each line of the blood purification unit 14.

[0038] The blood flow detector 17 is provided at a predetermined position in the blood purification device 1 and detects the direction, speed, and / or speed distribution of blood flow within the blood purification device 1. The blood flow detector 17 may also be provided at a predetermined position in the patient's body connected to the blood feed line 3, the blood return line 4, or the blood purification unit 14 and detect the direction, speed, and / or speed distribution of blood flow within the blood feed line 3, the blood return line 4, or the patient's body. The blood flow detector 17 can be, for example, an ultrasound diagnostic imaging device such as the Aixplorer manufactured by SuperSonic Imagine. The blood purification unit 14 can detect blood flow abnormalities in a short time and with high accuracy using the blood flow detector 17.

[0039] Hematocrit detector 18 is provided in blood return line 4 and measures the hematocrit value of the blood in blood return line 4. The hematocrit value is an index of blood concentration and is expressed as the volume ratio of red blood cells to whole blood. To check whether there is an abnormality in the amount of plasma permeating through blood purification device 1, hematocrit detector 18 is preferably provided near outlet port 1d. On the other hand, to check the difference between the hematocrit value of blood flowing into blood purification unit 14 and the hematocrit value of blood flowing out of blood purification unit 14, hematocrit detector 18 is preferably provided between blood collection section 33a and first pressure gauge 23 in blood delivery line 3 and between first flow meter 29 and blood return section 33b in blood return line 4. As the hematocrit detector 18, for example, StatStrip® Hb / Hct manufactured by NOVA® BIOMEDICAL can be used.

[0040] The first pressure gauge 23 is provided in the blood supply line 3 between the blood collection section 33a and the blood pump 5 and measures the blood pressure in the blood supply line 3. The first pressure gauge 21 is provided in the blood supply line 3 between the blood pump 5 and the blood purification device 1 and measures the blood pressure in the blood supply line 3. The first pressure gauge 22 is provided in the blood return line 4 between the blood purification device 1 and the blood return section 33b and measures the blood pressure in the blood return line 4. The first pressure gauges 21 and 22 can constantly measure the inlet and outlet pressures of the blood purification device 1, and the first pressure gauges 21 and 22 can measure the pressure loss of blood pressure due to the blood purification device 1. The second pressure gauge 25 is provided in the filtrate line 8 and measures the filtrate pressure in the filtrate line 8. The third pressure gauge 26 is provided in the dialysate line 10 and measures the dialysate pressure in the dialysate line 10. The fourth pressure gauge 27 is provided in the replacement fluid line 12 and measures the replacement fluid pressure in the replacement fluid line 12. As the first pressure gauges 21 to 23, the second pressure gauge 25, the third pressure gauge 26 and the fourth pressure gauge 27, for example, known water pressure gauges such as semiconductor piezo-resistance diffusion pressure sensors can be used.

[0041] The first flowmeter 28 is provided in the blood transfer line 3 and measures the blood flow rate therein. The first flowmeter 29 is provided in the blood return line 4 and measures the blood flow rate therein. The second flowmeter 30 is provided in the filtrate line 8 and measures the filtrate flow rate therein. The third flowmeter 31 is provided in the dialysate line 10 and measures the dialysate flow rate therein. The fourth flowmeter 32 is provided in the replacement fluid line 12 and measures the replacement fluid flow rate therein. The first flowmeters 28, 29, the second flowmeter 30, the third flowmeter 31, and the fourth flowmeter 32 can determine whether the flow rates in each line, which are controlled by pumps or the like in each line, are within a set range. The first flowmeters 28, 29, the second flowmeter 30, the third flowmeter 31, and the fourth flowmeter 32 can be known flowmeters, such as a Coriolis mass flowmeter, an electromagnetic mass flowmeter, or an ultrasonic mass flowmeter.

[0042] The blood flow detector 17, the hematocrit detector 18, the first pressure gauges 21-23, the second pressure gauge 25, the third pressure gauge 26, the fourth pressure gauge 27, the first flow meters 28, 29, the second flow meter 30, the third flow meter 31 and the fourth flow meter 32 are examples of detection units that detect blood information regarding the blood flowing in each line of the blood purification unit 14.

[0043] In a clinical environment, the blood purification unit 14 may also include an anticoagulant injector, an air bubble detector, an alarm function, etc. For safe use, the blood purification system 40 is preferably equipped with a power generator and a battery so that it can operate even in the event of a disaster or power outage.

[0044] Blood withdrawn from the patient via the blood collection section 33a is sent to the blood purification device 1 by the blood pump 5 through the blood supply line 3. The blood sent to the blood purification device 1 flows into the hollow membrane body 1e from the inlet port 1c and flows out into the blood return line 4 from the outlet port 1d. Meanwhile, the dialysate supplied from the replacement fluid container 7 is sent to the blood purification device 1 by the dialysate pump 11 through the dialysate line 10. The dialysate sent to the blood purification device 1 flows in from the dialysate inlet 1a, passes outside the hollow membrane body 1e, and undergoes dialysis with the liquid inside the hollow membrane body 1e, before flowing out from the dialysate outlet 1b into the filtrate line 8. Furthermore, the replacement fluid supplied from the replacement fluid container 7 is sent to the blood supply line 3 and the blood return line 4 by the replacement fluid pump 13 through the replacement fluid line 12. The replacement fluid sent to the blood supply line 3 flows into the hollow membrane body 1e from the inlet port 1c of the blood purification device 1, and then flows out from the dialysate outlet 1b to the filtrate line 8 together with the liquid containing waste products, etc. The dialysate, replacement fluid, and liquid containing waste products, etc. that flow out to the filtrate line 8 are discharged as filtrate to the outside of the unit by the filtrate pump 9. The blood and replacement fluid that flow out to the blood return line 4 are returned to the patient.

[0045] FIG. 3 is a diagram showing the schematic configuration of the blood purification system 40. As shown in FIG.

[0046] In addition to the above-described components, the blood purification unit 14 of the blood purification system 40 also includes a drive device 15, an electrocardiogram measuring device 41, a hemolysis measuring device 42, a pulse meter 43, a blood pressure monitor 44, a blood flow meter 45, and the like.

[0047] The drive device 15 includes one or more motors and drives the blood pump 5, filtrate pump 9, dialysate pump 11, and replacement fluid pump 13 in accordance with control signals from the control device 50, thereby controlling the flow of liquid in each line of the blood purification unit 14.

[0048] The electrocardiogram measuring device 41 is worn by a patient connected to the blood purification unit 14, measures the patient's electrocardiogram (heart rate waveform), and outputs the measured electrocardiogram. The electrocardiogram measuring device 41 may be a wearable electrocardiogram measuring device such as the Apple Watch (Series 4, 5, or 6). The Apple Watch (Series 4, 5, or 6) has a crystal and electrodes, and works with an electrocardiogram application to record an electrocardiogram similar to a lead I electrocardiogram. The electrocardiogram measuring device 41 continuously detects the heart rhythm and may notify the patient if an irregular heart rhythm that indicates atrial fibrillation (AFib) is detected.

[0049] The hemolysis measuring device 42 is connected to a patient connected to the blood purification unit 14 and measures the degree of hemolysis of the patient. Hemolysis refers to the destruction of blood cells, particularly red blood cells. The hemolysis measuring device 42 can be a blood leakage detector built into all commercially available dialysis monitoring devices (e.g., Toray TR-3300M).

[0050] The pulse meter 43 and blood pressure monitor 44 are attached to a patient connected to the blood purification unit 14 and measure the patient's pulse and blood pressure, respectively. The blood flow meter 45 is connected to a patient connected to the blood purification unit 14 and measures the patient's circulating blood flow rate. Known measuring devices can be used as the pulse meter 43, blood pressure monitor 44, and blood flow meter 45.

[0051] The control device 50 is an example of a learning device, and is an information processing device such as a personal computer. The control device 50 has an input device 51, a display device 52, a first communication device 53, an interface device 54, a first storage device 55, and a first processing device 56. The input device 51, the display device 52, the first communication device 53, the interface device 54, the first storage device 55, and the first processing device 56 are connected to each other via a CPU (Central Processing Unit) bus or the like.

[0052] The input device 51 has an input device such as a touch panel type input device, a keyboard, a mouse, etc., and an interface circuit for acquiring signals from the input device, and outputs operation signals in response to input operations by the user.

[0053] The display device 52 has a display such as a liquid crystal display or an organic EL (Electro-Luminescence) display, and an interface circuit that outputs image data to the display, and displays the image data on the display.

[0054] The first communication device 53 is an example of a communication unit. The first communication device 53 has a wired communication interface circuit that complies with a communication protocol such as TCP / IP (Transmission Control Protocol / Internet Protocol). The first communication device 53 is communicatively connected to the network 70 in accordance with a communication standard such as Ethernet (registered trademark). The first communication device 53 sends data received from the server 80 via the network 70 to the first processing device 56, and transmits data received from the first processing device 56 to the server 80 via the network 70. The first communication device 53 may have an antenna that transmits and receives wireless signals and a wireless communication interface circuit that complies with a communication protocol such as wireless LAN, and may be communicatively connected to the network 70 in accordance with a communication standard such as wireless LAN.

[0055] The interface device 54 has an interface circuit conforming to a serial bus such as a Universal Serial Bus (USB). The interface device 54 is connected to the drive device 15, magnetic force regulator 16, blood flow detector 17, hematocrit detector 18, first pressure gauges 21-23, second pressure gauge 25, third pressure gauge 26, fourth pressure gauge 27, first flow meters 28 and 29, second flow meter 30, third flow meter 31, fourth flow meter 32, electrocardiogram monitor 41, hemolysis monitor 42, pulse meter 43, sphygmomanometer 44, and blood flow meter 45 of the blood purification unit 14, and is provided to be able to communicate with each of the connected devices. The interface device 54 sends data received from each connected device to the first processing device 56 and transmits data received from the first processing device 56 to each connected device. The interface device 54 may have an interface circuit that complies with a short-range wireless communication standard such as Bluetooth (registered trademark), and may be connected wirelessly to communicate with each component of the blood purification unit 14.

[0056] The first storage device 55 is an example of a storage unit. The first storage device 55 includes a memory device such as a random access memory (RAM) or a read-only memory (ROM), a fixed disk device such as a hard disk, or a portable storage device such as a flexible disk or an optical disk. The first storage device 55 also stores computer programs, databases, tables, and the like used for various processes of the control device 50. The computer programs may be installed into the first storage device 55 from a computer-readable portable recording medium using a known setup program or the like. The portable recording medium is, for example, a compact disc read-only memory (CD-ROM) or a digital versatile disc read-only memory (DVD-ROM). The computer programs may also be installed from a predetermined server or the like.

[0057] The first storage device 55 stores data such as a learning model 551, product data 552, and a result table 553. The learning model 551 is a model for controlling the flow of blood in the blood purification unit 14. The learning model 551 is generated by the first processing device 56 or received from the server 80. The product data 552 is data related to the blood purification unit 14, and indicates the filtration performance, dialysis performance, etc., of the blood purification device 1. The product data 552 is set in advance by the user using the input device 51. The result table 553 stores the results of blood purification for each blood purification performed by the blood purification system 40. Details of the result table 553 will be described later.

[0058] The first processing device 56 operates based on a program stored in advance in the first storage device 55. The first processing device 56 is, for example, a CPU. A DSP (digital signal processor), an LSI (large scale integration), an ASIC (application specific integrated circuit), an FPGA (field-programmable gate array), etc. may be used as the first processing device 56. The first processing device 56 is connected to the input device 51, the display device 52, the first communication device 53, the interface device 54, the first storage device 55, etc., and controls each device. The first processing device 56 generates a learning model 551 and controls the blood flow in the blood purification unit 14 using the generated learning model 551.

[0059] The first processing device 56 reads the computer program stored in the first storage device 55 and operates in accordance with the read computer program. As a result, the first processing device 56 functions as a first data acquisition unit 561, a first generation unit 562, a first output control unit 563, a parameter acquisition unit 564, and a control unit 565. The first data acquisition unit 561, the first generation unit 562, and the first output control unit 563 are examples of a data acquisition unit, a generation unit, and an output control unit, respectively.

[0060] FIG. 4 is a schematic diagram showing an example of the data structure of the result table 553.

[0061] The result table 553 stores, in association with each other, an identification number (measurement ID), learning model, patient data, product data, blood data, clearance data, amount of causative substance removed, antithrombotic property, etc. for each blood purification performed by the blood purification system 40. The learning model is the learning model 551 used in the blood purification. Identification information or storage address, etc. of the learning model 551 used in the blood purification may also be stored as the learning model. The patient data is data related to the patient who underwent blood purification, such as the name, height, and weight of the patient. The product data is product data 552 preset by the user.

[0062] The blood data is data related to the blood flowing through each line of the blood purification unit 14 and includes the patient's pulse, blood pressure, circulating blood flow rate, hematocrit level in the blood, or degree of hemolysis before blood purification. The clearance data is data related to the blood purified by the blood purification system 40 and includes the patient's pulse, blood pressure, circulating blood flow rate, hematocrit level in the blood, or degree of hemolysis after blood purification. The clearance data may also include blood pressure, blood pressure loss, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, or replacement fluid flow rate measured during blood purification. The amount of causative substance removed is the amount of causative substance removed by the blood purification unit 14. Antithrombotic activity is the ability to inhibit activation of the blood coagulation system and indicates the degree of thrombus formation in the blood purified by the blood purification unit 14.

[0063] FIG. 5 is a diagram showing a schematic configuration of the server 80. As shown in FIG.

[0064] The server 80 is a host computer of the control device 50 and is an example of a learning device. The server 80 includes a second communication device 81, a second storage device 82, and a second processing device 83. The second communication device 81, the second storage device 82, and the second processing device 83 are connected to each other via a CPU bus or the like.

[0065] The second communication device 81 is an example of a communication unit for communicating with multiple blood purification systems 40. The second communication device 81 has a wired communication interface circuit conforming to a communication protocol such as TCP / IP. The second communication device 81 is communicatively connected to the network 70 in accordance with a communication standard such as Ethernet (registered trademark). The second communication device 81 sends data received from the control device 50 via the network 70 to the second processing device 83, and transmits data received from the second processing device 83 to the control device 50 via the network 70. The second communication device 81 may also have an antenna for transmitting and receiving wireless signals and a wireless communication interface circuit conforming to a communication protocol such as wireless LAN, and may be communicatively connected to the network 70 in accordance with a communication standard such as wireless LAN.

[0066] The second storage device 82 includes a memory device such as RAM or ROM, a fixed disk device such as a hard disk, or a portable storage device such as a flexible disk or optical disk. The second storage device 82 also stores computer programs, databases, tables, etc. used for various processes of the server 80. The computer programs may be installed into the second storage device 82 from a computer-readable portable recording medium such as a CD-ROM or DVD-ROM using a known setup program, etc. The computer programs may also be installed from a predetermined server, etc.

[0067] A learning model 821 and the like are stored as data in the second storage device 82. The learning model 821 is generated by the second processing device 83 or received from the control device 50.

[0068] The second processing device 83 operates based on a program stored in advance in the second storage device 82. The second processing device 83 is, for example, a CPU. A DSP, an LSI, an ASIC, an FPGA, etc. may be used as the second processing device 83. The second processing device 83 is connected to the second communication device 81, the second storage device 82, etc., and controls each device. The second communication device 81 generates a learning model 821 and transmits it to each control device 50.

[0069] The second processing device 83 reads the computer program stored in the second storage device 82 and operates in accordance with the read computer program. As a result, the second processing device 83 functions as a second data acquisition unit 831, a second generation unit 832, and a second output control unit 833.

[0070] FIG. 6 is a flowchart showing an example of the operation of the learning process of the control device 50.

[0071] An example of the operation of the learning process of the control device 50 will be described below with reference to the flowchart shown in Fig. 6. The flow of the operation described below is executed mainly by the first processing device 56 in cooperation with each element of the control device 50 based on a program stored in advance in the first storage device 55.

[0072] First, the first data acquisition unit 561 acquires blood information about the blood flowing through each line of the blood purification unit 14 (step S101). The blood information includes the degree of blood turbulence, blood vorticity, degree of heart murmur, blood pressure, blood pressure loss, filtrate pressure, dialysate pressure, replacement fluid pressure, blood flow rate, filtrate flow rate, dialysate flow rate, replacement fluid flow rate, fouling, hematocrit value in the blood, or the degree of hemolysis, pulse, blood pressure, or circulating blood flow rate of the patient. The blood information includes one or more of the above-mentioned parameters.

[0073] The first data acquisition unit 561 acquires the direction, velocity, and / or velocity distribution of blood flow within the blood purification unit 14 from the blood flow detector 17 via the interface device 54 and calculates the degree of blood turbulence and blood vorticity based on the acquired information. The first data acquisition unit 561, for example, calculates the Reynolds number for each blood flow detected by the blood flow detector 17 and determines whether each blood flow is turbulent or laminar based on whether the calculated Reynolds number is equal to or greater than a predetermined threshold. The first data acquisition unit 561 calculates the degree of turbulence as the ratio of the number of turbulent blood flows to the total number of blood flows detected by the blood flow detector 17. The first data acquisition unit 561 also calculates the velocity vector of the blood flow based on the direction and velocity of the blood flow acquired from the blood flow detector 17 and calculates the rotation of the vector field formed by the calculated velocity vector as vorticity. Vorticity is a quantity that expresses the state of rotation of a flow.

[0074] The first data acquisition unit 561 acquires an electrocardiogram of the patient connected to the blood purification unit 14 from the electrocardiogram measuring device 41 via the interface device 54 and calculates the degree of heart murmur based on the acquired electrocardiogram. Heart murmur is a cardiac noise that is out of harmony with the heartbeat and disrupts the rhythm. Heart murmur is a characteristic abnormal sound that occurs when blood flows through a heart valve or blood vessels near the heart (when the valve opens and closes). Abnormal sounds are mainly caused by defects in the heart valve. The first data acquisition unit 561 calculates the degree of heart murmur based on the percentage of irregular heartbeat rhythms suggestive of atrial fibrillation among the heartbeat rhythms shown in the acquired electrocardiogram. For example, the control device 50 stores waveform patterns of atrial fibrillation heartbeat rhythms in the first storage device 55 in advance. The first data acquisition unit 561 uses known pattern matching technology to detect waveforms similar to the heartbeat rhythm of atrial fibrillation among the heartbeat rhythms shown in the acquired electrocardiogram. Alternatively, the first data acquisition unit 561 detects P waves corresponding to each R wave within the cardiac rhythm shown in the acquired electrocardiogram, and detects the occurrence of a cardiac rhythm suggesting atrial fibrillation based on the number of P waves that have disappeared.

[0075] The first data acquiring unit 561 acquires blood pressures from the first pressure gauges 21 to 23 via the interface device 54. The first data acquiring unit 561 calculates a pressure loss of blood pressure by subtracting the blood pressure acquired from the first pressure gauge 22 from the blood pressure acquired from the first pressure gauge 21. The first data acquiring unit 561 also acquires the filtrate pressure, the dialysate pressure, and the replacement fluid pressure from the second pressure gauge 25, the third pressure gauge 26, and the fourth pressure gauge 27, respectively, via the interface device 54. The first data acquiring unit 561 also acquires the blood flow rate, the filtrate flow rate, the dialysate flow rate, and the replacement fluid flow rate from the first flow meters 28 and 29, the second flow meter 30, the third flow meter 31, and the fourth flow meter 32, respectively, via the interface device 54.

[0076] The first data acquisition unit 561 also calculates the amount of filtrate in the blood purification device 1 per unit time from the start of operation of the blood purification unit 14 to the present, based on the filtrate flow rate acquired from the second flow meter 30. The first data acquisition unit 561 calculates the pressure difference between the current filtrate pressure acquired from the second pressure gauge 25 and the blood pressure acquired from the first pressure gauge 21. The first data acquisition unit 561 divides the calculated filtrate amount by the calculated pressure difference, and then further divides this value by the unit time to calculate the fouling of the blood purification device 1.

[0077] The first data acquisition unit 561 acquires the hematocrit value in the blood from the hematocrit value detector 18 via the interface device 54. The first data acquisition unit 561 also acquires the degree of hemolysis, pulse, blood pressure, and circulating blood flow rate of the patient connected to the blood purification unit 14 from the hemolysis measuring device 42, pulse meter 43, sphygmomanometer 44, and blood flowmeter 45, respectively, via the interface device 54.

[0078] Next, the first data acquisition unit 561 acquires control parameters related to the flow of liquid in the blood purification unit 14 (step S102). The control parameters include the strength of the magnetic field applied to the blood in a predetermined direction by the magnetic force regulator 16, or the driving amount of the blood pump 5, the filtrate pump 9, the dialysate pump 11, or the replacement fluid pump 13. The control parameters include one or more of the above-mentioned parameters.

[0079] For example, the control device 50 stores various usable values ​​for each type of control parameter in the first storage device 55, and the first data acquisition unit 561 acquires the control parameters by sequentially reading out the values ​​stored in the first storage device 55. The first data acquisition unit 561 may acquire the control parameters by generating random numbers within a range of usable values ​​for each type of control parameter. Alternatively, the control device 50 may store optimal values ​​for each type of control parameter in the first storage device 55, and the first data acquisition unit 561 may acquire the control parameters by changing the optimal values ​​by a small amount.

[0080] Next, the first data acquisition unit 561 controls the magnetic force regulator 16 based on the acquired control parameters, or controls the blood pump 5, the filtrate pump 9, the dialysis fluid pump 11, or the replacement fluid pump 13 via the drive device 15 (step S103).

[0081] Next, first data acquisition unit 561 acquires blood information in the same manner as in step S101 (step S104). In this way, first data acquisition unit 561 controls the liquid control mechanism of blood purification unit 14 based on the control parameters acquired in step S102, and acquires blood information detected by the detection unit before and after controlling the liquid control mechanism based on the control parameters. In this way, first data acquisition unit 561 acquires a combination of blood information and control parameters.

[0082] Next, the first generating unit 562 sets a reward in the learning model 551 based on the blood information acquired by the first data acquiring unit 561 (step S105).

[0083] The learning model 551 used in the blood purification system 40 is trained, for example, by reinforcement learning. The learning model 551 is trained, for example, by Q-learning as reinforcement learning. The learning model 551 has an action value function that determines the value of control based on each control parameter, with the blood purification unit 14 as the environment, the control device 50 as the agent, blood information as the state, and control of the fluid control mechanism based on the control parameters as the action. The above-mentioned blood information is a physical quantity that changes by changing the above-mentioned control parameters. In other words, a correlation exists between each blood information and each control parameter, and the first generation unit 562 can generate a learning model 551 that can determine appropriate control parameters according to the state of the blood purification unit 14.

[0084] In Q-learning, the action value function Q(s, a) that represents the value of an action when action a is selected in state s is learned, with the environmental state s and the action a selected in that state s as independent variables. In Q-learning, learning begins when the correlation between state s and action a is unknown, and the action value function Q is iteratively updated by repeating trial and error to select various actions a in any state s. In addition, Q-learning is configured so that reward r is obtained when an action a in a certain state s is selected, and the action value function Q is learned so that an action a that obtains a higher reward r is selected. The update formula for the action value function Q is expressed as follows:

number

[0085] In the above formula, s t and a t are the state and action at time t, respectively, and action a t The state is s t From s t+1 It changes to r t+1 is the state st From s t+1 The term maxQ means the Q obtained when action a is taken that is considered to have the maximum value Q at time t+1. α and γ are the learning coefficient and discount rate, respectively, and are set arbitrarily between 0<α≦1 (usually 0.9-0.99) and 0<γ≦1 (usually around 0.1).

[0086] This update formula is given by t Actions in a t The evaluation value Q(s t ,a t ) the next state s t+1 Best Practices in Maxa t+1 The evaluation value Q(s t+1 ,maxa t+1 ) is larger, then Q(s t ,a t ) is increased, and if it is small, Q(s t ,a t ) is also reduced. In other words, this update formula brings the value of an action in a certain state closer to the value of the best action that results in the next state. Therefore, the action value function is updated so that the action value of the action (operating condition) that creates the most suitable state for operating the blood purification unit 14 becomes higher, that is, so that the action value of the optimal action (operating condition) for the blood purification unit 14 becomes higher.

[0087] The initial value of each action-value function Q is set arbitrarily. The first generating unit 562 uses the number of times step S106 is executed as the time in the above formula. The first generating unit 562 generates the blood information before control acquired in step S101 as the state s t and control based on the control parameters acquired in step S102 is performed as action a t The blood information after the control acquired in step S104 is identified as state s t+1 Identify as:

[0088] The first generating unit 562 sets the reward r based on the change in blood information (condition) before and after the control. The first generating unit 562 sets the reward r so that the smaller the change (difference) in the blood information after the control compared to the blood information before the control, the larger the reward r, and the larger the change (difference), the smaller the reward r. For example, one or more thresholds are set in advance for each piece of blood information, and the first generating unit 562 sets the reward r by comparing the amount of change in each piece of blood information with each threshold. If the amount of change is greater than the maximum value of the threshold, the first generating unit 562 may set the reward r to 0. In this way, the first generating unit 562 sets the reward r so that the more stable the blood condition in the blood purification unit 14 is when the blood purification unit 14 is controlled based on specific control parameters, the higher the reward r. This allows the first generating unit 562 to generate a learning model 551 that has been trained to select control parameters that will make the blood condition in the blood purification unit 14 more stable for the current blood condition.

[0089] Next, the first generating unit 562 updates the action value function based on the combination of the blood information and the control parameters acquired by the first data acquiring unit 561 and the set reward (step S106). t , action a t , state s t+1 Based on the set reward r, the action value function Q(s t ,a t ) to update the

[0090] Next, the first generating unit 562 determines whether a learning termination condition has been satisfied (step S107). The learning termination condition may be, for example, that the total number of updates of the action-value function has reached a predetermined number or that the maximum or minimum value of the number of updates of each action-value function has reached a predetermined number or more. If the learning termination condition has not yet been satisfied, the first data acquiring unit 561 and the first generating unit 562 return to step S101 and repeat steps S101 to S107. As a result, the first data acquiring unit 561 acquires multiple combinations of blood information and control parameters, and the first generating unit 562 updates the action-value function using each combination acquired by the first data acquiring unit 561. Note that, in the second and subsequent processing iterations, step S101 may be omitted, and the first data acquiring unit 561 may use the post-control blood information acquired in the immediately preceding step S104 as the pre-control blood information.

[0091] On the other hand, if the learning termination condition is satisfied, the first generation unit 562 generates a learning model 551 having a combination (action value table) of the final updated values ​​(action values) of each Q(s, a), and stores it in the first storage device 55 (step S108). When predetermined blood information is input as a state, the learning model 551 is trained to output control parameters corresponding to the action that will have the highest action value in that state, i.e., control parameters that can most stabilize the blood information. Note that the learning model 551 may also be trained to output the action value of each control parameter (each value) in that state when predetermined blood information is input as a state.

[0092] This allows the blood purification system 40 to automatically create optimal operating conditions for each elapsed time since the start of operation of the blood purification unit 14. As a result, the blood purification system 40 can derive optimal operating conditions for, for example, continuous hemodiafiltration, continuous hemofiltration, continuous hemodialysis, and apheresis.

[0093] Next, the first output control unit 563 outputs the learning model 551 generated by the first generation unit 562 by transmitting it to the server 80 via the first communication device 53 (step S109), thereby completing the series of steps. The learning model 551 is an example of information related to the learning model. Meanwhile, when the server 80 receives the learning model 551 from the control device 50 via the second communication device 81, the server 80 stores the received learning model 551 as a learning model 821 in the second storage device 82 and transmits it to another control device 50 via the second communication device 81. When the other control device 50 receives the learning model 821 from the server 80 via the first communication device 53, the other control device 50 stores the received learning model 821 as a learning model 551 in the first storage device 55. This allows the management system 100 to share the learning model among multiple blood purification systems 40, thereby improving the efficiency of generating the learning model. Note that the processing of step S109 may be omitted, and the control device 50 may use the learning model 551 generated by itself only within itself.

[0094] FIG. 7 is a flowchart showing an example of the operation of the control process of the control device 50.

[0095] An example of the control processing operation of the control device 50 will be described below with reference to the flowchart shown in Fig. 7. The flow of the operation described below is executed mainly by the first processing device 56 in cooperation with each element of the control device 50 based on a program stored in advance in the first storage device 55. The control processing is executed when the user issues a command to start blood purification using the input device 51.

[0096] First, similar to the processing of step S101 in FIG. 6, parameter acquisition unit 564 acquires blood information detected by the detection unit of blood purification unit 14 from blood purification unit 14 and stores it in first storage device 55 (step S201).

[0097] Next, the parameter acquisition unit 564 inputs the acquired blood information into the learning model 551 stored in the first storage device 55, and acquires the control parameters output from the learning model 551 (step S202).

[0098] Next, the control unit 565 controls the magnetic force regulator 16 based on the control parameters acquired by the parameter acquisition unit 564, or controls the blood pump 5, the filtrate pump 9, the dialysis fluid pump 11, or the replacement fluid pump 13 via the drive device 15 (step S203).

[0099] Next, first data acquisition unit 561 acquires blood information in the same manner as in the process of step S104 in FIG. 6, and stores the blood information in first storage device 55 (step S204).

[0100] Next, first generation unit 562 determines a reward in learning model 551 (step S205) in the same manner as in step S105 of Fig. 6. First generation unit 562 sets a reward based on the blood information acquired in step S201 and the change in the blood information acquired in step S204.

[0101] Next, the first generating unit 562 updates the action value function in the same manner as the processing of step S106 in Fig. 6 (step S206). The first generating unit 562 updates the action value function based on the blood information acquired in step S201, the blood information acquired in step S204, the control parameters acquired in step S202, and the reward set in step S206. Note that the processing of steps S204 to S206 may be omitted, and the first generating unit 562 does not need to update the learning model 551 in the control processing.

[0102] Next, the control unit 565 determines whether or not the user has instructed the end of blood purification using the input device 51 (step S207). If the end of blood purification has not yet been instructed, the control unit 565 returns the process to step S201 and repeats the processes of steps S201 to S207.

[0103] On the other hand, if an instruction to end blood purification is given, the control unit 565 stores the results of the control process in the result table 553 (step S208).

[0104] The controller 565 reads out the learning model 551 used in the current blood purification from the first storage device 55. The controller 565 also accepts patient data input by the user using the input device 51. The controller 565 also reads out product data 552 for the blood purification device 1 and the replacement fluid container 7 from the first storage device 55. The controller 565 also reads out the blood information first stored in step S201 from the first storage device 55 and acquires it as blood data related to the blood flowing through each line of the blood purification unit 14. The controller 565 also reads out each piece of blood information stored in step S204 from the first storage device 55 and acquires it as clearance data by the blood purification system 40. The controller 565 may also acquire only the blood information last stored in step S204 as clearance data by the blood purification system 40.

[0105] The control unit 565 also accepts input of the amount of causative substances removed from the patient by the user using the input device 51. Note that a measuring device for measuring the amount of causative substances removed may be connected to the patient connected to the blood purification unit 14, and the control unit 565 may obtain the amount of causative substances removed from the patient from the measuring device via the interface 50.

[0106] The control unit 565 also accepts the user's input of the patient's antithrombotic properties using the input device 51. For example, after blood purification is completed, blood is discharged from the blood purification unit 14, and a fixative such as glutaraldehyde is circulated for a predetermined time within the blood transmission line 3 and the blood return line 4 to fix thrombi formed in the hollow membrane body 1e. The blood purification device 1 is then removed from the blood purification unit 14, and the hollow membrane body 1e at the inlet portion of the removed blood purification device 1 is visually observed to evaluate the presence or absence of thrombus formation. The state of thrombi within the hollow membrane body 1e is also observed at predetermined sites using a scanning electron microscope. For example, the hollow membrane body 1e is divided vertically into three regions—the filtration side, the center, and the outside (opposite the filtration side)—and horizontally into three regions—the inlet side, the center, and the outlet side—and the following evaluation is performed for each of the 3×3 regions.

[0107] For example, approximately 15 hollow fiber membranes are randomly selected per region, and the cross-sectional area of ​​the thrombus formation portion of each hollow fiber membrane is measured. The average cross-sectional area of ​​the thrombus formation portion per hollow fiber membrane at each region is calculated. The ratio of the average cross-sectional area of ​​the thrombus formation portion to the average cross-sectional area of ​​the hollow fiber membranes is then calculated as the thrombus formation rate for each region. The antithrombogenicity of the blood purification device 1 is then evaluated using this thrombus formation rate as an index. For example, the thrombus formation rate for each region is scored into five levels: a thrombus formation rate of less than 1% is assigned a score of 0; a thrombus formation rate of 1% or more but less than 25% is assigned a score of 1; a thrombus formation rate of 25% or more but less than 50% is assigned a score of 2; a thrombus formation rate of 51% or more but less than 75% is assigned a score of 3; and a thrombus formation rate of 76% or more is assigned a score of 4. Alternatively, the average score may be calculated for each vertical region or each horizontal region. This allows the tendency of thrombus formation in each region of the hollow membrane body 1e to be grasped. The average score for all regions may be used as the evaluation score for the antithrombogenicity of the entire blood purification device 1. The lower the evaluation score, the higher the antithrombogenicity is evaluated to be.

[0108] The control unit 565 associates the learning model 551, patient data, product data 552, blood data, clearance data, amount of causative substance removed, and antithrombotic property with each other, assigns a new measurement ID, and stores it in the result table 553.

[0109] Next, the first output control unit 563 outputs the blood purification results by displaying them on the display device 52 (step S208), and the series of steps ends. The blood purification results are an example of information about the learning model. This allows the user to confirm the effects of the learning model 551, identify a highly effective learning model 551, and share it with other control devices 50.

[0110] Note that, instead of using the learning model stored in the control device 50, the control device 50 may acquire the control parameters using the learning model stored in the server 80. In this case, in step S202, the parameter acquisition unit 564 transmits the blood information to the server 80 via the first communication device 53. The second processing device 83 of the server 80 receives the blood information from the control device 50 via the second communication device 81, inputs the blood information to the learning model 821 stored in the second storage device 82, and acquires the control parameters output from the learning model 821. The second processing device 83 transmits the acquired control parameters to the control device 50 via the second communication device 81, and the parameter acquisition unit 564 acquires the control parameters by receiving them from the server 80 via the first communication device 53.

[0111] By utilizing the learning model 821 stored in the server 80, the control device 50 can appropriately control the blood purification system 40 using the latest learning model 821 updated by the server 80. On the other hand, by utilizing the learning model 551 stored in the control device 50 itself, the control device 50 can appropriately control the blood purification system 40 even when the communication connection with the server 80 is disconnected.

[0112] As described above in detail, the blood purification system 40 generates a learning model 551 based on blood information about the blood flowing through the blood purification unit 14 and the control parameters of the blood purification unit 14, and controls the blood purification unit 14 using the generated learning model 551. This enables the blood purification system 40 to learn, determine, and provide optimal operating conditions on its own. Therefore, the blood purification system 40 can further stabilize the condition of the blood flowing through the blood purification unit 14, enabling more appropriate blood purification.

[0113] In particular, the blood information includes the degree of blood turbulence or blood vorticity. The inventors discovered that blood turbulence (a turbulent fluid whose movement is constantly changing irregularly) and blood vorticity promote platelet production. Large changes in the degree of blood turbulence and blood vorticity make the blood purification device 1 more susceptible to fouling. Because the blood purification system 80 operates for several hours to several days and manual visual inspection and operation are limited, it is difficult to manually obtain optimal conditions for the degree of blood turbulence and blood vorticity. By using machine learning, the blood purification system 40 can obtain optimal conditions for the degree of blood turbulence and blood vorticity, especially optimal conditions that are difficult for humans to predict, thereby further reducing fouling in the blood purification device 1.

[0114] The blood information also includes the degree of heart murmur. The greater the degree of heart murmur, the less efficient the blood removal from the patient. Survey results show that, among patients using extracorporeal blood treatment devices such as the blood purification device 1, more than half of those diagnosed with ischemic heart disease report no symptoms. Myocardial infarction is particularly likely to occur during the first year after using an extracorporeal blood treatment device. By using machine learning, the blood purification system 40 can obtain optimal conditions for the degree of heart murmur, particularly optimal conditions that are difficult for humans to predict, thereby reducing the likelihood of ischemic heart disease in patients using the blood purification device 1. Furthermore, the blood purification system 80 includes an electrocardiogram monitor 41, making it possible to raise awareness of ischemic heart disease in patients.

[0115] The control parameters also include the strength of the magnetic field applied to the blood in a predetermined direction. Even a slight change in magnetic field strength can have a significant impact on blood flow, making it difficult to appropriately control the magnetic field strength. In particular, when the magnetic field strength changes, the blood flow does not change immediately but after a period of time, making it difficult to appropriately control the magnetic field strength. Because the magnetic field strength requires delicate adjustment, it is difficult to obtain optimal conditions through manual visual inspection and operation. By using machine learning, the blood purification system 40 can obtain optimal conditions for magnetic field strength, especially optimal conditions that are difficult for humans to predict.

[0116] As a result of extensive research and experimentation, the inventors have found that optimal operating conditions can be obtained by providing the blood purification system 40 with a self-learning function. In particular, the blood purification system 40 can clarify and provide operating conditions that can enhance the antithrombogenicity of the blood purification device 1 used in continuous hemodiafiltration, extend its lifetime, and reduce fouling.

[0117] Furthermore, while it generally takes about three days to obtain appropriate operating conditions using a closed circulation test device, the blood purification system 40 uses machine learning technology to enable appropriate operating conditions to be obtained in a short period of time. Furthermore, the control device 50 is able to evaluate the performance of the blood purification device 1 while performing filtrate and / or water removal in the blood purification unit 14, enabling efficient performance evaluation of the blood purification device 1. Furthermore, the control device 50 is able to set the amount of filtrate, the amount of water removed, etc. in the blood purification unit 14, and collectively and appropriately manage the operation of multiple pumps.

[0118] Furthermore, since the control device 50 that controls the blood purification unit 14 generates the learning model 551, the blood purification system 40 can generate the learning model 551 with a simple configuration.

[0119] 8 is a flowchart showing an example of the operation of the learning process of the server 80 according to another embodiment. In this embodiment, the second data acquisition unit 831, the second generation unit 832, and the second output control unit 833 of the server 80 are examples of a data acquisition unit, a generation unit, and an output control unit, respectively.

[0120] An example of the operation of the learning process of the server 80 will be described below with reference to the flowchart shown in Fig. 8. The operation flow described below is executed mainly by the second processing device 83 in cooperation with each element of the server 80 based on a program stored in advance in the second storage device 82.

[0121] First, the second data acquisition unit 831 acquires multiple combinations of blood information and control parameters by receiving them from the control device 50, i.e., the blood purification system 40, via the second communication device 81 (step S301). The first data acquisition unit 561 of the control device 50 repeatedly executes the processes of steps S101 to S104 of FIG. 6 to acquire multiple combinations of blood information and control parameters, and transmits them to the server 80 via the first communication device 53. The second data acquisition unit 831 acquires multiple combinations of blood information and control parameters by receiving them from the control device 50 via the second communication device 81. Note that the second data acquisition unit 831 may also acquire combinations of blood information and control parameters by receiving them from multiple control devices 50, i.e., multiple blood purification systems 40. This allows the second data acquisition unit 831 to efficiently acquire learning data for the learning model 821.

[0122] Next, second generating unit 832 determines a reward corresponding to each combination of blood information and control parameters, in the same manner as in the process of step S105 in FIG. 6 (step S302).

[0123] Next, the second generation unit 832 updates the action value function for each combination of blood information and control parameter based on the combination of blood information and control parameter and the set reward, in the same manner as the processing in step S106 of FIG. 6 (step S303).

[0124] Next, the second generation unit 832 generates a learning model 821 having a combination (action value table) of the final updated values ​​(action values) of each Q(s, a), similar to the processing of step S108 in Figure 6, and stores it in the second storage device 82 (step S304).

[0125] Next, the second output control unit 833 outputs the learning model 821 generated by the second generation unit 832 by transmitting it to each control device 50 via the second communication device 81 (step S305), and ends the series of steps. The learning model 821 is an example of information about the learning model. On the other hand, when each control device 50 receives the learning model 821 from the server 80 via the first communication device 53, it stores the received learning model 821 in the first storage device 55 as the learning model 551.

[0126] As described above in detail, the blood purification system 40 can perform more appropriate blood purification even when the server 80 generates the learning model 821.

[0127] In particular, the management system 100 enables the learning models used by each blood purification system 40 to be centrally managed on the server 80, thereby making it possible to suppress variations in the accuracy of the learning models used by each blood purification system 40.

[0128] 8 may be executed by each control device 50 instead of the server 80. That is, each control device 50 may acquire multiple combinations of blood information and control parameters from other control devices 50, and generate a learning model 551 using the acquired combinations.

[0129] FIG. 9 is a schematic diagram showing a blood purification unit 14-2 according to yet another embodiment.

[0130] The blood purification unit 14-2 has the same components as the blood purification unit 14 and is used in place of the blood purification unit 14. However, the blood purification unit 14-2 does not include the replacement fluid line 12, the replacement fluid pump 13, the fourth pressure gauge 27, and the fourth flow meter 32. The dialysate line 10 is further connected to the blood return line 4, and sends the dialysate and / or replacement fluid flowing out of the replacement fluid container 7 to the blood return line 4 via the dialysate pump 11. The transfer of the dialysate or replacement fluid to the dialysate inlet 1a or the blood return line 4 via the dialysate pump 11 can be achieved by, for example, a three-way valve (not shown).

[0131] The dialysate supplied from the replacement fluid container 7 passes through a dialysate line 10 and is sent to the blood purification device 1 by a dialysate pump 11. The dialysate sent to the blood purification device 1 flows in from a dialysate inlet 1a, passes outside the hollow membrane body 1e, and is dialyzed against the liquid inside the hollow membrane body 1e, before flowing out from a dialysate outlet 1b into a filtrate line 8. The replacement fluid supplied from the replacement fluid container 7 passes through the dialysate line 10 and is sent by the dialysate pump 11 to a blood return line 4. The dialysate and liquid containing waste products and the like that flow out into the filtrate line 8 are discharged outside the unit by a filtrate pump 9. The replacement fluid that flows out into the blood return line 4 is returned to the patient together with blood.

[0132] The control device 50 controls the blood purification unit 14-2 in the same manner as when controlling the blood purification unit 14. However, when the blood purification unit 14-2 is used, the control parameters of the blood purification unit 14-2 do not include the drive amount of the fluid replacement pump 13. When the blood purification unit 14-3 is used, the fluid replacement pressure and fluid replacement flow rate included in the blood information are measured by the third pressure gauge 26 and the third flow meter 31, respectively.

[0133] FIG. 10 is a schematic diagram showing a blood purification unit 14-3 according to yet another embodiment.

[0134] The blood purification unit 14-3 has all the components of the blood purification unit 14 and is used in place of the blood purification unit 14. However, the blood purification unit 14-3 does not have the piping systems 33, 33′, (three-way) valves 34, 34′, or piping systems 35, 35′. Instead, it has a blood bag 2, a resistance-providing member 6, and open / close ports 24, 24′. The filtrate line 8 is connected to a fluid replacement container 7, and filtrate flowing out of the blood purification device 1 is sent to the fluid replacement container 7 via the filtrate pump 8. The blood purification unit 14-3 is used in a non-clinical environment where no patient is involved, to use the blood purification device 1 under conditions that are nearly identical to those in actual use in terms of blood flow, blood pressure, filtrate volume, and water removal volume. The blood purification unit 14-3 allows comparative evaluation of the performance of the blood purification device 1, such as antithrombogenicity and lifetime, as well as fouling evaluation.

[0135] The blood purification unit 14-3 has a closed circuit in which a test liquid circulates without contact with the atmosphere through the blood purification device 1. Human blood (whole blood) is used as the test liquid, but the test liquid is not limited to this, and other liquids such as animal blood having blood components similar to those of human blood or artificial blood may also be used as the test liquid.

[0136] The blood sending line 3 and the blood returning line 4 are connected via the blood bag 2 .

[0137] The resistance-applying member 6 is provided in the blood return line 4. The resistance-applying member 6 may be provided in the blood transmission line 3 instead of or in addition to the blood return line 4. The resistance-applying member 6 is used to apply resistance to the blood transmission line 3 or the blood return line 4 at its location, thereby adjusting the flow rate or pressure of the test liquid (blood) to the actual use environment. In particular, the resistance-applying member 6 simulates peripheral resistance in the human body and applies throttling resistance to the blood return line 4, thereby functioning as a vein model that simulates the veins of the human body and adjusts the flow of the test liquid. For example, a clamp that can change the magnitude of the force (resistance) applied to each line by driving a motor is used as the resistance-applying member 6. Various other devices, such as valves, can also be used as the resistance-applying member 6. The resistance-applying member 6 is an example of a liquid control mechanism. The drive device 15 further includes a motor for driving the resistance-applying member 6.

[0138] The open / close ports 24, 24' are configured with stopcocks or the like that can be switched between an open state, which allows the supply or discharge of test liquid to or from the blood supply line 3, and a closed state, which disables the supply or discharge of test liquid. The open / close ports 24, 24' are set to the open state when taking a sample of the test liquid during a test or when replacing the test liquid after a test, and are set to the closed state at other times. When the open / close ports 24, 24' are set to the closed state, the entire circuit of the blood purification unit 14-3 is maintained in a state free from air contact.

[0139] The blood purification unit 14-3 preferably includes a thermostatic means for regulating the temperature of the blood purification device 1, blood bag 2, replacement fluid container 7, and the entire blood purification unit 14-3 to maintain a constant temperature for the various fluids within the blood purification unit 14-3. The thermostatic means includes, for example, a water tank containing water and a heater for maintaining the water temperature within the water tank at a predetermined temperature. By placing the blood bag 2 and a portion of the blood supply line 3 in the water tank, it is possible to maintain the test fluid flowing through the blood supply line 3 and the blood return line 4 at a constant temperature equivalent to human body temperature (approximately 36 to 37°C). Similarly, by placing the replacement fluid container 7 and portions of the filtrate line 8, dialysate line 10, and replacement fluid line 12 in the water tank, it is possible to maintain the dialysate or replacement fluid flowing through the filtrate line 8, dialysate line 10, and replacement fluid line 12 at a constant temperature equivalent to human body temperature (approximately 36 to 37°C). The constant temperature means may include a heater that maintains the sealed space housing the entire blood purification unit 14-3 at a predetermined temperature.

[0140] In order to simulate the effect of differential pressure due to the difference in elevation between the devices in the liquid circuit of the blood purification unit 14 used during actual blood filtration, the components of the blood purification unit 14-3 are positioned to have a difference in elevation that generates a similar differential pressure. Furthermore, the components of the blood purification unit 14-3 are positioned taking into consideration the effect of gravity due to this difference in elevation. For example, the blood pump 5 is positioned at the highest point. The blood pump 5 is positioned at a height of approximately 600 mm to 700 mm from the lowest point, i.e., the installation surface of the blood purification unit 14-3. The blood purification device 1 is held with the inlet port 1c facing upward and the outlet port 1d facing downward. The upper end of the blood purification device 1 is positioned at a height of approximately 400 mm to 500 mm from the installation surface.

[0141] The control device 50 controls the blood purification unit 14-3 in the same way as when controlling the blood purification unit 14. However, when the blood purification unit 14-3 is used, the control parameters of the blood purification unit 14-3 include the magnitude of the resistance (resistance amount) applied by the resistance-applying member 6. Furthermore, when the blood purification unit 14-3 is used, the blood information does not include the level of cardiac murmur, the patient's blood pressure, the patient's level of hemolysis, pulse rate, blood pressure, or circulating blood flow rate.

[0142] By adjusting the amounts of filtrate, dialysate, and / or replacement fluid in the blood purification unit 14-3, it is possible to evaluate the antithrombotic properties and / or lifetime of the blood purification device 1. Below, we will explain the test methods for evaluating the antithrombotic properties and lifetime of the blood purification device 1 using the blood purification unit 14-3.

[0143] After the blood purification device 1 to be tested is installed (set) in the blood purification unit 14-3, blood is filled into the blood supply line 3 and blood return line 4 as a test liquid, and dialysate or replacement fluid is filled into the filtrate line 8, dialysate line 10, and replacement fluid line 12. The blood pump 5, filtrate pump 9, dialysate pump 11, and replacement fluid pump 13 are driven. Under conditions identical to those in an actual usage environment, blood is given a pulsating flow by the blood pump 5, passes through the blood pump 5 from the blood bag 2, flows into the blood purification device 1 from the inlet port 1c, and passes through the hollow membrane body 1e. The blood that has passed through the hollow membrane body 1e flows out into the blood return line 4 from the outlet port 1d. Meanwhile, the dialysate supplied from the replacement fluid container 7 passes through the dialysate pump 11 and flows into the blood purification device 1 from the dialysate inlet 1a. The dialysate passes through the outside of the hollow membrane body 1e, undergoes dialysis with the liquid inside the hollow membrane body 1e, and then flows out from the dialysate outlet 1b into the filtrate line 8. The replacement fluid supplied from the replacement fluid container 7 passes through the replacement fluid pump 13 and is sent to the blood feed line 3 and the blood return line 4. The replacement fluid sent to the blood feed line 3 flows into the blood purification device 1 from the inlet port 1c, passes through the hollow membrane body 1e, and flows out from the dialysate outlet 1b into the filtrate line 8 together with a liquid containing waste products and the like. The dialysate, replacement fluid, and liquid containing waste products and the like that flow out into the filtrate line 8 are returned to the replacement fluid container 7 by the filtrate pump 9. The blood and replacement fluid that flow out into the blood return line 4 pass through the resistance-providing member 6 and are returned to the blood bag 2.

[0144] The blood pump 5, filtrate pump 9, dialysate pump 11, and replacement fluid pump 13 are continuously driven for a time period equivalent to the actual operating environment (e.g., approximately 3 hours to 3 days). During this time, the first pressure gauges 21-23, the second pressure gauge 25, the third pressure gauge 26, the fourth pressure gauge 27, the first flow meters 28 and 29, the second flow meter 30, the third flow meter 31, and the fourth flow meter 32 are periodically monitored to obtain data on changes over time in the inlet pressure, outlet pressure, and differential pressure of the blood purification device 1. The control device 50 can calculate the lifetime of the blood purification device 1 from the obtained data. When the inlet pressure of the blood purification device 1 rises from an initial value (e.g., 70 mmHg) to a predetermined value (e.g., 150 mmHg), the blood pump 5, the filtrate pump 9, the dialysate pump 11, and the replacement fluid pump 13 are stopped, even if the aforementioned operating time has not yet elapsed, and the test is terminated. The elapsed time (operating time) since the start of the test is also obtained as data.

[0145] During the test, blood flowing through the blood supply line 3 is sampled at predetermined time intervals, and various components are measured at each sample. Data on changes over time in these components is also obtained. After the test is completed, the blood is discharged from the blood purification unit 14-3, and a fixative such as glutaraldehyde is circulated within the blood supply line 3 and the blood return line 4 for a predetermined time to fix thrombi formed in the hollow membrane body 1e. During this test, the operating conditions of the blood pump 5, filtrate pump 9, dialysate pump 11, and replacement fluid pump 13 are set to the same conditions as those used in the blood test. The blood purification device 1 is then removed from the blood purification unit 14-3, and the antithrombotic properties of the removed blood purification device 1 are evaluated. Thus, in this embodiment, an evaluation test of the blood purification device 1 is performed without contact with the atmosphere, while maintaining the flow rate, pressure, and components of the test liquid at desired levels. This test is performed in a non-clinical environment, without a patient, that is substantially identical to an actual use environment involving a patient.

[0146] FIG. 11 is a schematic diagram showing a blood purification unit 14-4 according to yet another embodiment.

[0147] The blood purification unit 14-4 has all the components of the blood purification unit 14-2 and is used in place of the blood purification unit 14-2. However, the blood purification unit 14-4 does not have the piping systems 33, 33', (three-way) valves 34, 34', or piping systems 35, 35'. Instead, it has a blood bag 2, a resistance member 6, and open / close ports 24, 24'. The blood bag 2, resistance member 6, and open / close ports 24, 24' have the same configurations as the blood bag 2, resistance member 6, and open / close ports 24, 24' of the blood purification unit 14-3. Like the blood purification unit 14-3, the blood purification unit 14-4 is used in a non-clinical environment not involving use on a patient, in order to utilize the blood purification device 1 under conditions that are substantially identical to those in actual use in terms of blood flow, blood pressure, filtrate volume, and water removal volume.

[0148] The control device 50 controls the blood purification unit 14-4 in the same way as it controls the blood purification unit 14-2. However, when the blood purification unit 14-4 is used, the control parameters of the blood purification unit 14-4 include the magnitude of the resistance (resistance amount) provided by the resistance-providing member 6. Furthermore, when the blood purification unit 14-4 is used, the blood information does not include the degree of cardiac murmur, the patient's blood pressure, the patient's degree of hemolysis, pulse rate, blood pressure, or circulating blood flow rate.

[0149] In the blood purification unit 14-4, blood given a pulsating flow by the blood pump 5 passes from the blood bag 2 through the blood pump 5, flows into the blood purification device 1 through the inlet port 1c, and passes through the hollow membrane body 1e. The blood that has passed through the hollow membrane body 1e flows out into the blood return line 4 through the outlet port 1d. Meanwhile, the dialysate supplied from the replacement fluid container 7 passes through the dialysate pump 11, flows into the blood purification device 1 through the dialysate inlet 1a, passes outside the hollow membrane body 1e, and undergoes dialysis with the liquid inside the hollow membrane body 1e before flowing out into the filtrate line 8 through the dialysate outlet 1b. The replacement fluid supplied from the replacement fluid container 7 passes through the dialysate line 10 and is sent by the dialysate pump 11 to the blood return line 4. The dialysate and liquid containing waste products that has flowed out into the filtrate line 8 are returned to the replacement fluid container 7 by the filtrate pump 9. The blood and replacement fluid flowing out into the blood return line 4 pass through the resistance imparting member 6 and are returned to the blood bag 2.

[0150] The embodiments are not limited to those described above. For example, the control device 50 and the blood purification unit 14 may be configured as an integrated device rather than as separate devices. In this case, for example, each device of the blood purification unit 14 is directly connected to a CPU bus or the like of the control device 50, and transmits and receives information to and from the first processing device 56 of the control device 50 via the CPU bus or the like.

[0151] The learning model may also be trained by a method other than reinforcement learning. For example, the learning model is pre-trained by supervised learning such as deep learning. In this case, multiple pieces of blood information and control parameters capable of stabilizing the blood state indicated by each piece of blood information are used as training data. The learning model is trained so that when each piece of blood information is input, it outputs control parameters capable of stabilizing the blood state indicated by each piece of blood information. The learning model may also be trained by unsupervised learning, semi-supervised learning, transduction, multitask learning, etc.

[0152] Furthermore, a blood purification device with an apheresis function may be used as the blood purification device 1. Furthermore, the blood purification unit 14 may be a combination of a blood purification device that separates plasma components and cellular components from blood and a device that separates disease-causing factors from the separated plasma components. In the blood purification unit 14, a device that separates disease-causing factors may be provided upstream or downstream of the blood purification device 1 (dialyzer). In this way, the blood purification system 40 may be used for the purpose of apheresis. When used for the purpose of apheresis, the blood purification system 40 makes it possible to clarify and provide operating conditions that can reduce disease-causing substances. [Explanation of symbols]

[0153] 1 Blood purification device, 3 Blood supply line, 4 Blood return line, 5 Blood pump, 6 Resistance applying member, 7 Replacement fluid container, 8 Filtrate line, 9 Filtrate pump, 10 Dialysis fluid line, 11 Dialysis fluid pump, 12 Replacement fluid line, 13 Replacement fluid pump, 14, 14-2, 14-3, 14-4 Blood purification unit, 21 to 23 First pressure gauge, 25 Second pressure gauge, 26 Third pressure gauge, 27 Fourth pressure gauge, 28, 29 First flow meter, 30 Second flow meter, 31 Third flow meter, 32 Fourth flow meter, 40 Blood purification system, 50 Control device, 53 First communication device, 55 First storage device, 551 Learning model, 561 First data acquisition unit, 562 First generation unit, 563 First output control unit, 564 Parameter acquisition unit, 565 Control unit, 80 Server, 81 Second communication device, 821 Learning model, 831 second data acquisition unit, 832 second generation unit, 833 second output control unit

Claims

1. A line through which a fluid containing blood or filtrate flows; a blood purification device for purifying blood flowing through the line; A supplier for supplying a dialysis fluid or a replacement fluid to the line; A detection unit that detects blood information related to blood flowing through the line; a liquid control mechanism for controlling a flow of liquid in the line based on a control parameter; a parameter acquisition unit that inputs the blood information detected by the detection unit into a learning model that has been trained to output a predetermined control parameter when predetermined blood information is input, and acquires the control parameter output from the learning model; A control unit that controls the liquid control mechanism based on the control parameters acquired by the parameter acquisition unit, The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A blood purification system comprising:

2. the learning model has an action value function in which the blood information is a state and the control based on the control parameter is an action, The blood purification system according to claim 1 , wherein the action value function is updated based on a reward that is set to be larger the smaller the change in the blood information is.

3. the liquid control mechanism includes a magnetic force regulator that applies a magnetic field in a predetermined direction to the blood, a pump that controls the flow of liquid in the line, or a resistance applying member that applies resistance to the line; 3. The blood purification system according to claim 1, wherein the control parameters include at least one of the strength of the magnetic field applied by the magnetic force regulator, the driving amount of the pump, and the magnitude of the resistance applied by the resistance applying member.

4. The blood purification system according to any one of claims 1 to 3, further comprising a memory unit that stores the learning model in association with product data of the blood purification device, data related to blood flowing through the lines, clearance data by the blood purification system, the amount of causative substance removed, or antithrombotic property.

5. The blood purification system according to any one of claims 1 to 4, further comprising a communication unit that receives the learning model from a learning device.

6. The blood purification system according to any one of claims 1 to 4, further comprising a generation unit that controls the liquid control mechanism based on specific control parameters, and generates the learning model based on blood information detected by the detection unit before and after controlling the liquid control mechanism and the specific control parameters.

7. The blood purification system according to any one of claims 1 to 6, wherein the blood purification system is an extracorporeal circulation blood purification system.

8. The blood purification system according to claim 7 , wherein the blood purification system performs continuous hemodiafiltration, continuous hemofiltration, continuous hemodialysis, or apheresis.

9. A control method for a blood purification system having a line through which a liquid including blood, filtrate, dialysis fluid, or replacement fluid flows, a blood purification device for purifying the blood flowing in the line, a supplier for supplying the dialysis fluid or replacement fluid to the line, a detection unit for detecting blood information related to the blood flowing in the line, and a liquid control mechanism for controlling the flow of the liquid in the line based on a control parameter, comprising: inputting the blood information detected by the detection unit into a learning model that has been trained to output a predetermined control parameter when predetermined blood information is input, and acquiring the control parameter output from the learning model; controlling the liquid control mechanism based on the acquired control parameters; The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A control method comprising:

10. A control program for a computer included in a blood purification system having a line through which a liquid including blood, filtrate, dialysis fluid, or replacement fluid flows, a blood purification device for purifying the blood flowing in the line, a supplier for supplying the dialysis fluid or replacement fluid to the line, a detector for detecting blood information related to the blood flowing in the line, and a liquid control mechanism for controlling the flow of the liquid in the line based on a control parameter, comprising: inputting the blood information detected by the detection unit into a learning model that has been trained to output a predetermined control parameter when predetermined blood information is input, and acquiring the control parameter output from the learning model; controlling the liquid control mechanism based on the acquired control parameters; The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A control program comprising:

11. a blood purification system including a line through which a fluid including blood, filtrate, dialysis fluid, or replacement fluid flows, a blood purification device for purifying the blood flowing in the line, a supplier for supplying the dialysis fluid or replacement fluid to the line, a detector for detecting blood information related to the blood flowing in the line, and a fluid control mechanism for controlling the flow of the fluid in the line based on control parameters, the system comprising: a data acquisition unit for acquiring a plurality of combinations of the blood information and the control parameters; a generation unit that generates a learning model that is trained to output a predetermined control parameter when predetermined blood information is input, using the combination acquired by the data acquisition unit; An output control unit that outputs information about the learning model, The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A learning device characterized by:

12. a communication unit for communicating with the blood purification systems; The learning device according to claim 11 , wherein the data acquisition unit acquires the combinations by receiving them from the plurality of blood purification systems via the communication unit.

13. The learning device described in claim 11, wherein the data acquisition unit acquires the combination by controlling the liquid control mechanism based on specific control parameters and acquiring blood information detected by the detection unit before and after controlling the liquid control mechanism based on the specific control parameters.

14. The computer a blood purification system including a line through which a liquid including blood, filtrate, dialysis fluid, or replacement fluid flows, a blood purification device for purifying the blood flowing through the line, a supplier for supplying the dialysis fluid or replacement fluid to the line, a detector for detecting blood information related to the blood flowing through the line, and a liquid control mechanism for controlling the flow of the liquid in the line based on control parameters, comprising: acquiring a plurality of combinations of the blood information and the control parameters; generating a learning model that is trained to output a predetermined control parameter when a predetermined blood information is input using the acquired combination; outputting information about the learning model; The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A learning method comprising:

15. A control program for a computer, comprising: a blood purification system including a line through which a liquid including blood, filtrate, dialysis fluid, or replacement fluid flows, a blood purification device for purifying the blood flowing through the line, a supplier for supplying the dialysis fluid or replacement fluid to the line, a detector for detecting blood information related to the blood flowing through the line, and a liquid control mechanism for controlling the flow of the liquid in the line based on control parameters, comprising: acquiring a plurality of combinations of the blood information and the control parameters; generating a learning model that is trained to output a predetermined control parameter when a predetermined blood information is input using the acquired combination; outputting information about the learning model; The blood information includes at least one of a degree of blood turbulence, a degree of blood vorticity, a degree of heart murmur, a pressure loss of blood pressure, a filtrate pressure, a dialysate pressure, a replacement fluid pressure, fouling, and a degree of hemolysis; The learning model is trained so that a change in the blood information before and after control of the flow of the liquid in the line based on a control parameter output from the learning model is small. A control program comprising:

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