Ventricular simulator and cardiac-pulsation-imitating in-vitro blood circulation simulation device

Abstract

The invention belongs to the technical field of medical instrument experiments, and particularly relates to a ventricle simulator and an in-vitro blood circulation simulation device simulating cardiac pulsation. The ventricular simulator comprises a ventricular cavity, a ventricular simulator body, a ventricular simulator body and a ventricular simulator body, the bionic ventricle is hollow, openings are formed in the two transverse ends of the bionic ventricle, the bionic ventricle can be contracted or relaxed and is transversely arranged in the ventricle cavity, and the two ends of the bionic ventricle and the two ends of the ventricle cavity are sealed and fixed through a front connecting cover and a rear connecting cover, so that the interior of the bionic ventricle is separated from the ventricle cavity; the front connecting cover and the rear connecting cover are each provided with a transverse communicating opening communicating with the interior of the bionic ventricle. The ventricle simulator innovatively realizes complete isolation of an internal circulation system and an external driving system, reduces external interference and pollution, and ensures stable operation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical device experiments, and particularly relates to a ventricular simulator and an in vitro blood circulation simulation device for simulating heart beats. Background Art

[0002] Cardiovascular diseases are one of the main causes of human death. Due to ethical restrictions and high costs in animal and human experiments, the research and development of cardiovascular medical devices have progressed slowly. In vitro blood circulation simulation devices can simulate human blood flow dynamics and provide key support for device research and development, but existing systems have obvious deficiencies.

[0003] Firstly, most systems directly drive the circulating liquid with a rigid piston, resulting in liquid leakage, pollution and corrosion caused by the contact between the piston and the liquid, and platform vibration caused by friction and high-frequency movement, which affects the accuracy of pressure data; existing pneumatically driven devices use air pumps and solenoid valve groups, and it is difficult to control the intake air volume each time, resulting in instability and low repeatability accuracy;

[0004] Secondly, existing ventricular simulators cannot effectively reproduce the real heart beating mechanism;

[0005] Thirdly, the aortic valve and mitral valve are mostly replaced by rigid check valves, lacking the simulation of the physiological characteristics of human valves. Not only does it require a certain opening pressure and has a large flow resistance, but also hydraulic shock will be generated at the moment of closing; in addition, parameters such as vascular compliance, vascular resistance, and initial ventricular volume are mostly fixed values or need to be manually adjusted, lacking high repeatability and precise regulation capabilities;

[0006] Finally, the trend of driving the change of ventricular volume lacks physiological compatibility and cannot accurately reflect the law of human ventricular volume change.

[0007] In summary, there is still a large room for improvement in existing in vitro blood circulation simulation devices in accurately simulating human ventricular volume and pressure dynamics, realizing fine parameter regulation, and reproducing real blood flow scenarios. Summary of the Invention

[0008] The present invention aims at the above technical problems and provides a ventricular simulator and an in vitro blood circulation simulation device for simulating heart beats.

[0009] A ventricular simulator includes:

[0010] A ventricular cavity provided with an air path interface communicating inside and outside;

[0011] The bionic ventricle is internally hollow and has openings at both lateral ends. It can contract or relax and is horizontally arranged inside the ventricle cavity. It is hermetically fixed at both ends of the bionic ventricle and both ends of the ventricle cavity by a front connection cover and a rear connection cover, so that the interior of the bionic ventricle is separated from the ventricle cavity. The front connection cover and the rear connection cover are both provided with horizontal communication ports communicating with the interior of the bionic ventricle.

[0012] Optionally, the ventricle cavity is further provided with a pneumatic sensor interface communicating with the inside and outside, and the pneumatic sensor interface is connected to a pneumatic sensor for driving the ventricle cavity.

[0013] Optionally, the gas path interface on the ventricle cavity is connected to a quick-connect gas path joint.

[0014] Optionally, connection flanges are respectively arranged at both lateral ends of the bionic ventricle, and the front connection cover and the rear connection cover press and fix the connection flanges at both ends to both ends of the bionic ventricle.

[0015] Optionally, a liquid is injected into the ventricle cavity, and the liquid completely covers the bionic ventricle.

[0016] Optionally, the ventricle cavity is an acrylic ventricle cavity made of acrylic material.

[0017] Optionally, the bionic ventricle is a silicone ventricle made of silicone material.

[0018] Preferably, the bionic ventricle is a silicone ventricle made of AB silicone material according to a volume ratio of 1:1.

[0019] More preferably, the bionic ventricle is a silicone ventricle made of silicone material with a Young's modulus of 20 kPa - 50 kPa.

[0020] Most preferably, the bionic ventricle is a silicone ventricle made of Ecoflex 0030 platinum-catalyzed silicone material.

[0021] Optionally, the bionic ventricle is designed in the following manner:

[0022] According to the structure and shape of the human ventricle, an initial bionic ventricle is designed, and the shape of the initial bionic ventricle is designed as a semi-ellipsoid;

[0023] The initial bionic ventricle is reasonably scaled so that the volume range of the initial bionic ventricle is 180 ml - 240 ml, and the size of the ellipsoid of the initial bionic ventricle is 35 mm × 35 mm × 45 mm.

[0024] Optionally, the bionic ventricle is fabricated in the following manner:

[0025] Making a bionic ventricle mold using additive manufacturing technology, including a left mold, a right mold, and an inner mold;

[0026] The left mold and the right mold are connected. The outer diameter of the inner mold is consistent with the inner diameter of the bionic ventricle, and the inner diameters of the left mold and the right mold are consistent with the outer diameter of the bionic ventricle to achieve precise docking;

[0027] Spray a release agent on the surface of the bionic ventricle mold. After standing, prepare a mixed solution according to the designed volume of the bionic ventricle and stir it evenly;

[0028] To eliminate air bubbles, it is preferably to extract the air bubbles in the mixed solution through a vacuum pump before pouring it into the bionic ventricle mold, and then pour the bubble-free mixed solution into the bionic ventricle mold;

[0029] To ensure that the mixed solution fills the bionic ventricle mold and the air bubbles are completely discharged, it is preferably to inject through a syringe, and put the bionic ventricle mold filled with the mixed solution into a vacuum environment again for degassing;

[0030] Finally, put the bionic ventricle mold into an oven for baking. After the bionic ventricle mold cools down, take it out and disassemble it to obtain the bionic ventricle.

[0031] Optionally, the ventricle simulator further includes:

[0032] A ventricle simulator bracket for supporting and fixing the ventricle cavity.

[0033] Optionally, the ventricle simulator bracket includes:

[0034] A bottom bracket for supporting the ventricle cavity;

[0035] A top fastening bracket fastened to the outer surface of the upper part of the ventricle cavity to connect and fix the bottom bracket.

[0036] An extracorporeal blood circulation simulation device for simulating heart pulsation, including:

[0037] The ventricle simulator of the present invention;

[0038] An external drive system with a drive control device. The drive control device is connected to the gas path interface of the ventricle cavity through a gas path, and the drive control device provides compressed gas to the ventricle cavity;

[0039] Internal simulated liquid circulation system, having an aortic valve simulator, an arterial compliance simulation device, a vascular resistance simulator, a venous atrium simulator, and a mitral valve simulator connected in sequence through pipelines. The aortic valve simulator is connected to the front side of the ventricular simulator and can communicate unidirectionally with the interior of the bionic ventricle. The mitral valve simulator is connected to the rear side of the ventricular simulator and can communicate unidirectionally with the interior of the bionic ventricle.

[0040] Optionally, the drive control device includes:

[0041] A power and transmission unit, having a linear motion end;

[0042] An actuator, including a plunger mechanism. The plunger mechanism includes a syringe barrel sleeve and a syringe barrel push rod. One end of the syringe barrel sleeve is provided with a compressed gas outlet. The compressed gas outlet is connected to the gas path interface of the ventricular cavity through a connecting air pipe. One end of the syringe barrel push rod extends into the other end of the syringe barrel sleeve, and the other end of the syringe barrel push rod is connected to the linear motion end. The power and transmission unit drives one end of the syringe barrel push rod to perform linear motion in the syringe barrel sleeve, so as to send the compressed gas in the syringe barrel sleeve to the ventricular cavity through the connecting air pipe.

[0043] Optionally, the power and transmission unit includes:

[0044] A servo motor;

[0045] A ball screw, one end of its screw rod is connected to the motor shaft of the servo motor through a coupling;

[0046] A ball slide table, connected to the nut of the ball screw, and used as the linear motion end to connect the other end of the syringe barrel push rod through a push rod clamp.

[0047] Optionally, the drive control device further includes:

[0048] A control unit, including a servo driver, a motion control card, and an industrial computer connected in sequence. The servo driver is connected to the control end of the servo motor.

[0049] Optionally, a syringe barrel push rod displacement curve is preset in the industrial computer. The industrial computer converts the syringe barrel push rod displacement curve into a motor drive signal and dynamically adjusts the linear motion of the syringe barrel push rod through a preset closed-loop PID algorithm.

[0050] Optionally, the syringe barrel push rod displacement curve is obtained in the following manner:

[0051] Using a neural network model to train the relationship between the motion of the syringe barrel push rod and related inputs to generate a syringe barrel push rod displacement curve;

[0052] Alternatively, by utilizing the law of the change of the cardiac volume with the cardiac cycle in medicine, it is converted into the displacement curve of the syringe push rod.

[0053] Optionally, the initial volume setting process of the ventricular simulator is as follows:

[0054] Start the external drive system, and set the initial ventricular volume target value as the target ventricular volume;

[0055] Based on the angular position information of the servo motor, determine the current sleeve volume of the syringe sleeve, calculate the current ventricular volume according to the relationship between the sleeve volume and the ventricular volume, and compare the current ventricular volume with the target ventricular volume;

[0056] If the current ventricular volume is less than the target ventricular volume, by retracting the syringe push rod, reduce the air volume in the ventricular cavity, thereby increasing the current ventricular volume of the bionic ventricle until the target ventricular volume is reached;

[0057] If the current ventricular volume is greater than the target ventricular volume, by pushing the syringe push rod, increase the air volume in the ventricular cavity, thereby reducing the current ventricular volume of the bionic ventricle until the target ventricular volume is reached.

[0058] Optionally, the actuator further includes:

[0059] One or several support structures, the support structure includes a support frame and a V-shaped positioning fixture fixed on the support frame, and the V-shaped positioning fixture supports on the outer peripheral surface of the syringe sleeve.

[0060] Optionally, the connecting air pipe adopts an anti-turbulence air pipe.

[0061] Optionally, the aortic valve simulator and the mitral valve simulator, as one-way valve devices for imitating heart valves, both include:

[0062] Bionic valves, the bionic valve of the aortic valve simulator is a bionic aortic valve, and the bionic valve of the mitral valve simulator is a bionic mitral valve;

[0063] Valve support, having a support through hole penetrating front and back, sealed and connected to the bionic valve on one side and sealed and connected to the ventricular simulator on the other side;

[0064] Connector, having a connector through hole penetrating front and back, sleeved outside the bionic valve, detachably connected to the valve support on one side, the other side of the connector of the aortic valve simulator is connected to the arterial compliance simulation device through a pipeline, and the other side of the connector of the mitral valve simulator is connected to the venous atrium simulator through a pipeline.

[0065] Optionally, the bionic valve is hermetically connected to the corresponding valve support through a medical-grade adhesive.

[0066] Optionally, the connector and the valve support are reversibly assembled by threaded connection.

[0067] Optionally, a pressure detection channel communicating inside and outside is provided in the middle of the bionic aortic valve, a pressure detection interface is provided at the end of the pressure detection channel, and the pressure detection interface is connected to a left ventricular pressure sensor.

[0068] Optionally, the bionic valve is a silicone valve made of silicone material.

[0069] The bionic valve is preferably a silicone valve made of AB silicone material according to a volume ratio of 1:1.

[0070] The bionic valve is more preferably a silicone valve made of Ecoflex 0030 platinum-catalyzed silicone material.

[0071] Optionally, the bionic valve is designed in the following manner:

[0072] According to the shape and functional characteristics of the three-leaf valve of the human heart, a bionic valve is designed. The bionic valve includes three valves, and the elastic modulus of the valves matches that of the human valves.

[0073] Optionally, the diameter of the bionic valve is 20 mm - 25 mm, the thickness is 0.7 mm - 0.9 mm, and the thickness is preferably 0.8 mm.

[0074] Optionally, the bionic valve is manufactured in the following manner:

[0075] Use a stereolithography 3D printing technology to make the required valve mold, evenly spray a release agent on the surface of the valve mold and let it stand;

[0076] Prepare a mixed solution and stir it evenly. Preferably, before pouring the mixed solution into the valve mold, pump out the air bubbles in the mixed solution through a vacuum pump, and then pour the bubble-free mixed solution into the valve mold;

[0077] Close the valve mold and place the valve mold in an oven for baking. After the valve mold cools down, take it out and open the valve mold to obtain the bionic valve.

[0078] Optionally, the arterial compliance simulation device includes:

[0079] An integrated bionic cavity, having a lower base and an upper adjustment chamber formed integrally. Two pipe connectors communicating inside and outside are provided on the lower base. One of the pipe connectors is connected to the aortic valve simulator through a pipeline, and the other pipe connector is connected to the vascular resistance simulator through a pipeline. A transmission window and a tracheal connection interface communicating inside and outside are provided on the upper part of the upper adjustment chamber;

[0080] A displacement sensor, installed on the top of the upper adjustment chamber, with the detection end facing the transmission window;

[0081] A pressure regulating mechanism, including a solenoid valve, a pressure reducing valve and a pressure gas cylinder connected in sequence through a pipeline. One interface of the solenoid valve is connected to the tracheal connection interface through a delivery air pipe, and the other interface of the solenoid valve communicates with the external atmospheric environment.

[0082] Optionally, the integrated bionic cavity adopts a transparent acrylic cavity.

[0083] Optionally, the integrated bionic cavity is processed to form a composite cavity structure using biocompatible polymethyl methacrylate (PMMA).

[0084] Optionally, the transmission window is a laser transmission window with an anti-fog coating.

[0085] Optionally, the pressure reducing valve adopts a digital display pressure reducing valve.

[0086] Optionally, the pressure gas cylinder adopts a medical-grade 316L stainless steel gas cylinder.

[0087] Optionally, the delivery air pipe adopts a silicone air pipe.

[0088] Optionally, the pressure regulating mechanism provides an adjustable pressure of 0 - 300 mmHg to the integrated bionic cavity through the delivery air pipe.

[0089] Optionally, the arterial compliance simulation device further includes:

[0090] A gas cylinder fixing device, connecting and supporting the pressure gas cylinder;

[0091] Optionally, the arterial compliance simulation device further includes:

[0092] A solenoid valve support, connecting and supporting the solenoid valve.

[0093] Optionally, a branch pipe joint is provided on the pipeline connecting the arterial compliance simulation device and the aortic valve simulator, and the branch pipe joint is connected to an aortic pressure sensor;

[0094] The solenoid valve used is a solenoid valve with a PID self-tuning algorithm. The solenoid valve adjusts the air volume in the upper adjustment chamber in a closed-loop manner according to the detection results of the displacement sensor and the aortic pressure sensor.

[0095] Optionally, the arterial compliance simulation device further includes a dynamic compliance calculation module, and the dynamic compliance calculation module is used for:

[0096] Real-time monitoring of the displacement of the gas-liquid interface through the displacement sensor via the transmission window, converting the monitored displacement of the gas-liquid interface into a volume change ΔV through a displacement-volume calibration curve; obtaining the pressure change value ΔP detected by the aortic pressure sensor; dynamically calculating the current vascular compliance C value based on C = ΔV / ΔP, comparing the current vascular compliance C value with a preset target compliance value, calculating the deviation amount, and performing non-linear volume compensation calculation using a preset PID self-tuning algorithm according to the deviation amount to determine the volume change amount to be adjusted; dynamically adjusting the gas volume in the upper adjustment chamber by the solenoid valve according to the volume change amount with a volume control accuracy of ±N mL; monitoring the displacement of the gas-liquid interface and the pressure change value again, calculating a new vascular compliance C value, evaluating the adjustment effect, and if the new vascular compliance C value still does not reach the preset target compliance value, repeating the above adjustment process until the vascular compliance C value reaches the preset target compliance value;

[0097] Wherein, N is a preset value.

[0098] Optionally, an ultrasonic flow sensor is installed on the pipeline connecting the arterial compliance simulation device and the aortic valve simulator.

[0099] Optionally, the vascular resistance simulator includes:

[0100] A valve body having a laterally penetrating valve body through-hole, one side of the valve body through-hole is connected to the arterial compliance simulation device, and the other side of the valve body through-hole is connected to the venous atrium simulator;

[0101] A valve plug, the lower part of which extends into the valve body and is rotatably connected to the valve body, and the bottom can be closely matched with the size of the valve body;

[0102] A driving motor drives the valve plug to rotate, so that the valve plug realizes stepless adjustment in the valve body.

[0103] Optionally, a first gear is fixed on the output shaft of the driving motor, a second gear is fixed on the valve plug, the second gear is meshed and connected with the first gear, and the driving motor drives the first gear to rotate, and then drives the second gear to rotate, and finally drives the valve plug to rotate.

[0104] Optionally, the resistance adjustment method of the vascular resistance simulator is as follows:

[0105] Set the target resistance valve R value range according to the experimental requirements; drive the valve plug to rotate to a preset initial position by the driving motor; calculate the current resistance valve R value according to the initial position, and judge whether the current resistance valve R value is greater than the target resistance valve R value range. If it is greater, drive the driving motor to reverse, so that the valve plug rotates in the valve body to increase the flow cross-sectional area. If it is less, drive the driving motor to rotate forward, so that the valve plug rotates in the valve body to reduce the flow cross-sectional area; calculate the new resistance valve R value again according to the rotation position of the valve plug, and judge whether the new resistance valve R value is within the target resistance valve R value range. If so, the resistance adjustment is completed, otherwise repeat the above adjustment process until the resistance valve R value is within the target resistance valve R value range.

[0106] Optionally, the venous atrium simulator includes:

[0107] A container, with two internally and externally connected container interfaces for connecting pipelines at the bottom. One container interface is connected to the vascular resistance simulator through a pipeline, and the other container interface is connected to the mitral valve simulator through a pipeline. There is an openable top cover above the container, and a constant temperature heating device is provided inside the container.

[0108] Optionally, the container is made of an acrylic container.

[0109] Optionally, the container is a cuboid container.

[0110] Beneficial effects: The present invention has at least one or more of the following advantages:

[0111] 1. High-fidelity ventricular simulation, truly restoring the mechanical characteristics of the heart: Using a bionic ventricle, especially a flexible silicone ventricle, to simulate the human myocardium. Its elastic modulus matches that of human myocardial tissue, strictly reproducing the volume change and mechanical response of the left ventricle, and effectively avoiding the negative pressure effect.

[0112] The present invention innovatively realizes the complete isolation of the internal circulation system and the external drive system through the ventricular simulator, reduces external interference and pollution, and ensures stable operation. At the same time, this design significantly improves the simulation accuracy of in vitro hemodynamics and ensures the physiological credibility of experimental data.

[0113] 2. Precise drive control, realizing the reproduction of real pulsation: Introducing a drive control device with gas-liquid hybrid drive, combined with a servo motor-ball screw system, ensuring that the periodic intake and exhaust gas volumes are the same, moving according to the displacement curve output by the medical data model or the experimental neural network model, and converting it into a drive signal, so that the bionic ventricle contracts and expands precisely according to the real cardiac pulsation cycle, accurately simulating the blood pumping characteristics of the heart.

[0114] 3. Bionic valve structure to optimize hydrodynamic characteristics: Integrate a highly bionic three-leaf valve, using a highly elastic material similar to human valves, enabling it to open and close smoothly under low pressure differences, significantly reducing hydraulic shock, improving the blood flow stability of the system and the accuracy of hydrodynamic simulation, and enhancing the test reliability of cardiovascular devices.

[0115] 4. Dynamic vascular compliance regulation to ensure physiological simulation accuracy: Adopt the air spring principle combined with a PID closed-loop control system, and adjust the air chamber volume in real time through a solenoid valve group and a displacement sensor to achieve automatic dynamic regulation of vascular compliance, improve the experimental repeatability and simulation accuracy, and be applicable to the simulation requirements of different physiological and pathological states.

[0116] 5. Stepless regulation of vascular resistance to enhance adaptability and flexibility: Use a spiral mechanism to achieve stepless regulation of the flow cross-sectional area in the range of 0 - 100%, and combine the closed-loop feedback control of the motor rotation angle to accurately control vascular resistance, ensuring that it can accurately match the physiological resistance changes under different fluid conditions and meet the requirements of various experimental environments.

[0117] 6. Closed-loop circulation system to ensure safe and stable operation: Each module is connected through pipelines to form a highly simulated closed-loop fluid circulation system, ensuring low-resistance unidirectional flow, effectively reducing turbulent flow and vibration interference, and at the same time avoiding liquid leakage, improving the safety and reliability of the experimental system. Description of the Drawings

[0118] Figure 1 is a schematic structural diagram of the present invention;

[0119] Figure 2 is Figure 1 the front view of

[0120] Figure 3 is Figure 1 the top view of

[0121] Figure 4 is a main schematic structural diagram of a ventricular simulator provided by the present invention;

[0122] Figure 5 is Figure 4 a cross-sectional view of

[0123] Figure 6 (a) to (f) are schematic diagrams of the pulsation process of a ventricular simulator provided by the present invention;

[0124] Figure 7 is the initial volume adjustment process of a ventricular simulator provided by the present invention;

[0125] Figure 8 is a schematic diagram of the manufacturing process of a bionic ventricle provided by the present invention;

[0126] Figure 9 It is a schematic diagram of the manufacturing process of the bionic valve provided by the present invention;

[0127] Figure 10 It is a schematic diagram of the manufacturing process of the aortic valve simulator provided by the present invention;

[0128] Figure 11 It is a schematic diagram of the manufacturing process of the mitral valve simulator provided by the present invention;

[0129] Figure 12 It is a schematic structural diagram of a driving control device provided by the present invention;

[0130] Figure 13 It is a schematic diagram of training a neural network with experimental data provided by the present invention;

[0131] Figure 14 It is a schematic diagram of the displacement curve of the syringe push rod controlled by the neural network model provided by the present invention;

[0132] Figure 15 It is a schematic diagram of the displacement curve of the syringe push rod controlled by the medical data model provided by the present invention;

[0133] Figure 16 It is a schematic control diagram of the control unit provided by the present invention;

[0134] Figure 17 It is a schematic structural diagram of an arterial compliance simulation device provided by the present invention;

[0135] Figure 18 It is a schematic diagram of the automatic regulation process of arterial compliance provided by the present invention;

[0136] Figure 19 It is a schematic structural diagram of a vascular resistance simulator provided by the present invention;

[0137] Figure 20 It is a cross-sectional view of a vascular resistance simulator provided by the present invention;

[0138] Figure 21 It is a schematic diagram of the automatic regulation process of vascular resistance provided by the present invention;

[0139] Figure 22 It is a flowchart of the operation of an in vitro blood circulation simulation device that mimics heart pulsation provided by the present invention. Detailed implementation manners

[0140] The preferred embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings, so as to more clearly understand the purpose, features and advantages of the present invention. It should be understood that the embodiments shown in the drawings are not a limitation on the scope of the present invention, but only to illustrate the essential spirit of the technical solution of the present invention.

[0141] In the following description, certain specific details are set forth in order to provide a thorough understanding of various disclosed embodiments. However, one of ordinary skill in the relevant art will recognize that the embodiments may be practiced without one or more of these specific details. In other instances, well-known devices, structures, and techniques associated with the present application may not be shown or described in detail to avoid unnecessarily obscuring the description of the embodiments.

[0142] References throughout this specification to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" throughout the specification are not necessarily all referring to the same embodiment. Additionally, the particular features, structures, or characteristics may be combined in any manner in one or more embodiments.

[0143] In the following description, in order to clearly show the structure and working mode of the present invention, many directional terms will be used for description. However, words such as "front", "rear", "left", "right", "outer", "inner", "outward", "inward", "up", "down", etc. should be understood as convenient terms and should not be understood as limiting terms.

[0144] Embodiment 1:

[0145] This embodiment provides a ventricular simulator, which can be used in an extracorporeal blood circulation simulation device for simulating heart pulsation.

[0146] Referring to Figures 4 to 6 , the ventricular simulator 1 includes a bionic ventricle 1-1, a front connection cover 1-2, a ventricular cavity 1-3, and a rear connection cover 1-4.

[0147] Preferably, an air path interface communicating inside and outside is provided at the top of the ventricular cavity 1-3, and the air path interface is used to connect to an external driving system that provides compressed gas.

[0148] The bionic ventricle 1-1 can contract or relax, and it can simulate the contraction and relaxation processes of the heart under the pressure of compressed air. The bionic ventricle 1-1 is hollow inside and has openings at both lateral ends. The bionic ventricle 1-1 is horizontally arranged in the ventricle cavity 1-3 and is hermetically fixed at both ends of the bionic ventricle 1-1 and the two ends of the ventricle cavity 1-3 by the front connection cover 1-2 and the rear connection cover 1-4, so that the inside of the bionic ventricle 1-1 is separated from the ventricle cavity 1-3. Both the front connection cover 1-2 and the rear connection cover 1-4 are provided with horizontal communication ports communicating with the inside of the bionic ventricle 1-1, and the horizontal communication ports on the front and rear sides can be respectively connected to other external components to form an internal circulation system.

[0149] Both the front and rear ends of the bionic ventricle 1-1 of the present invention are directly connected to the internal circulation system to realize the connection of the fluid passage; at the same time, the external drive system and the internal circulation system are effectively isolated by the bionic ventricle 1-1, ensuring that the two do not physically contact each other, avoiding the direct interference of the external power source on the internal fluid environment, thereby ensuring the stability and accuracy of the system and reducing the vibration of the platform and the fluctuation of the pressure data.

[0150] In one embodiment, preferably, an air pressure sensor interface communicating inside and outside is further provided on the top of the ventricle cavity 1-3, and the air pressure sensor interface is connected to the ventricle cavity driving air pressure sensor 9-3.

[0151] The air pressure information inside the ventricle cavity 1-3 can be monitored through the ventricle cavity driving air pressure sensor 9-3.

[0152] In one embodiment, the air path interface on the ventricle cavity 1-3 is connected to a quick-connect air path joint.

[0153] The ventricle cavity 1-3 is connected to the external drive system through the quick-connect air path joint.

[0154] In one embodiment, connecting flanges are respectively arranged at both lateral ends of the bionic ventricle 1-1, and the front connection cover 1-2 and the rear connection cover 1-4 press and fix the connecting flanges at both ends to the two ends of the bionic ventricle 1-1.

[0155] During specific implementation, pressing and fixing can be carried out through bolts, and a bolt locking structure is formed between the front connection cover 1-2 / rear connection cover 1-4, the connecting flange and the bionic ventricle 1-1 to ensure its stability.

[0156] In one embodiment, a liquid is injected into the ventricle cavity 1-3, and the liquid completely covers the bionic ventricle 1-1 to provide an initial pressure and maintain its original shape.

[0157] After injecting liquid into the ventricular cavity 1-3 in this embodiment, when external compressed gas enters the ventricular cavity 1-3, the compressed gas applies pressure to the liquid in the ventricular cavity 1-3, and the pressure is transmitted to the bionic ventricle 1-1 through the liquid. After the bionic ventricle 1-1 is stressed, it will undergo periodic contraction and expansion, thereby driving the simulated liquid inside the bionic ventricle 1-1 to circulate, realizing the simulation of the heart pumping process, such as Figure 6 in (a) to (c) of Figure 6 is the contraction simulation process of the bionic ventricle 1-1, and in (d) to (f) of

[0158] is the expansion simulation process of the bionic ventricle 1-1. This embodiment achieves the purpose of gas-liquid hybrid drive.

[0159] In one embodiment, the ventricular cavity 1-3 is an acrylic ventricular cavity 1-3 made of acrylic material.

[0160] The bionic ventricle 1-1 of this embodiment is made of a silicone material with an elastic modulus close to that of the human ventricular wall to ensure that it exhibits a mechanical response similar to that of the real heart when stressed, avoiding the occurrence of negative pressure, thereby highly simulating the cardiac pulsation characteristics and realizing a more realistic simulation of extracorporeal blood circulation.

[0161] When the bionic ventricle 1-1 is manufactured, its shape and size match the anatomical structure of the human left ventricle.

[0162] Preferably, the bionic ventricle 1-1 is a silicone ventricle made of AB silicone material in a volume ratio of 1:1.

[0163] More preferably, the bionic ventricle 1-1 is a silicone ventricle made of a silicone material with a Young's modulus of 20 kPa - 50 kPa.

[0164] Most preferably, the bionic ventricle 1-1 is a silicone ventricle made of Ecoflex 0030 platinum-catalyzed silicone material to ensure the flexibility and biocompatibility of the material.

[0165] In one embodiment, the bionic ventricle 1-1 is designed as follows:

[0166] According to the structure and shape of the human ventricle, an initial bionic ventricle 1-1 similar to it is designed, and the shape of the initial bionic ventricle 1-1 is designed as a semi-ellipsoid;

[0167] Considering factors such as the compressibility, delay, and resistance of air in actual driving, the initial bionic ventricle 1-1 is reasonably scaled so that the volume range of the initial bionic ventricle 1-1 is 180 ml - 240 ml, and the size of the ellipsoid of the initial bionic ventricle 1-1 is 35 mm × 35 mm × 45 mm.

[0168] In one embodiment, referring to Figure 8 , the bionic ventricle 1-1 is fabricated in the following manner:

[0169] Utilize additive manufacturing technology to fabricate a bionic ventricle mold, including a left mold 1-1-1, a right mold 1-1-2, and an inner mold 1-1-3. The left mold 1-1-1 and the right mold 1-1-2 are connected. The outer diameter of the inner mold 1-1-3 is consistent with the inner diameter of the bionic ventricle 1-1, and the inner diameters of the left mold 1-1-1 and the right mold 1-1-2 are consistent with the outer diameter of the bionic ventricle 1-1 to achieve precise docking. Spray a release agent on the surface of the bionic ventricle mold. After standing, according to the designed volume of the bionic ventricle 1-1, configure a mixture and stir evenly. To eliminate air bubbles, it is preferred to extract the air bubbles in the mixture through a vacuum pump before pouring it into the bionic ventricle mold, and then pour the bubble-free mixture into the bionic ventricle mold. To ensure that the mixture fills the bionic ventricle mold and the air bubbles are completely discharged, it is preferred to inject through a syringe and place the bionic ventricle mold filled with the mixture back into a vacuum environment for degassing. Finally, place the bionic ventricle mold in an oven for baking. After the bionic ventricle mold cools down, take it out and disassemble it to obtain the bionic ventricle 1-1.

[0170] The mixture in the above manufacturing process is preferably a silicone liquid.

[0171] In specific implementation, the left mold 1-1-1 and the right mold 1-1-2 are preferably connected through a locking structure of grooves and protrusions designed on the edges.

[0172] In specific implementation, spray a release agent on the surface of the bionic ventricle mold and wait for 15 to 20 minutes before pouring the mixture into the bionic ventricle mold.

[0173] In specific implementation, place the bionic ventricle mold in an oven, set the temperature to 50°C - 70°C, preferably 60°C, and bake for 10 to 30 minutes, preferably 20 minutes.

[0174] In one embodiment, the ventricle simulator 1 further includes a ventricle simulator bracket that supports and fixes the ventricle cavity.

[0175] In one embodiment, referring to Figure 4 and Figure 5 , the ventricle simulator bracket includes a top fastening bracket 1-5 and a bottom bracket 1-6.

[0176] The top fastening bracket 1-5 is fastened to the outer surface of the upper part of the ventricle cavity 1-3. Preferably, the two are connected and fixed by bolts to ensure the mechanical reliability of the overall device. The bottom bracket 1-6 is connected and fixed below the top fastening bracket 1-5. The bottom bracket 1-6 supports the ventricle cavity 1-3.

[0177] During specific implementation, the bottom bracket 1-6 is fastened to the fiberglass board with holes by fasteners such as bolts, and the fiberglass board is installed on the experimental table to achieve the installation purpose of the ventricular simulator 1.

[0178] Embodiment 2:

[0179] Referring to Figures 1 to 3 , this embodiment provides an in vitro blood circulation simulation device that mimics cardiac pulsation. The in vitro blood circulation simulation device includes the ventricular simulator 1 provided in each embodiment of Embodiment 1 of the present invention, an external drive system, and an internal simulated liquid circulation system.

[0180] The external drive system has a drive control device 4. The drive control device 4 is connected to the gas path interface of the ventricular cavity 1-3 through a gas path, and the drive control device 4 supplies compressed gas to the ventricular cavity 1-3. After the compressed gas enters the ventricular cavity 1-3, it exerts pressure on the liquid in the ventricular cavity 1-3, and then acts on the bionic ventricle 1-1. Under the drive of gas pressure, the bionic ventricle 1-1 simulates the contraction and expansion of cardiac muscle, realizes bionic pulsation, drives the circulating flow of the internal simulated liquid, and thus reproduces the cardiac pumping process. The gas-liquid hybrid driving force ensures a flexible driving force and simulates the myocardial driving principle in the mode of omnidirectional extrusion force on the bionic ventricle 1-1.

[0181] The internal simulated liquid circulation system has an aortic valve simulator 2, an arterial compliance simulation device 5, a vascular resistance simulator 6, a venous atrium simulator 7, and a mitral valve simulator 3 connected in sequence through pipelines. The aortic valve simulator 2 is connected to the front side of the ventricular simulator 1 and can be unidirectionally communicated with the inside of the bionic ventricle 1-1. The mitral valve simulator 3 is connected to the rear side of the ventricular simulator 1 and can be unidirectionally communicated with the inside of the bionic ventricle 1-1, so that both the front and rear ends of the bionic ventricle 1-1 are directly connected to the circulatory system, realizing the connection of the fluid path.

[0182] In one embodiment, referring to Figure 1 , the pipelines used for connecting the components in the internal simulated liquid circulation system are PVC pipes 11, preferably PVC hoses.

[0183] In one embodiment, referring to Figure 12 , the drive control device 4 includes a power and transmission unit and an actuator. The power and transmission unit has a linear motion end. The actuator includes a plunger mechanism, and the plunger mechanism includes a syringe push rod 4-6 and a syringe sleeve 4-7.

[0184] One end of the syringe barrel sleeve 4-7 is provided with a compressed gas outlet. The compressed gas outlet is connected to the gas path interface of the ventricular cavity 1-3 through a connecting air pipe. One end of the syringe plunger 4-6 extends into the other end of the syringe barrel sleeve 4-7. The other end of the syringe plunger 4-6 is connected to the linear motion end. The power and transmission unit drives one end of the syringe plunger 4-6 to perform linear motion within the syringe barrel sleeve 4-7, so as to send the compressed gas in the syringe barrel sleeve 4-7 to the ventricular cavity 1-3 through the connecting air pipe, and control the pressure change in the ventricular cavity 1-3.

[0185] In this embodiment, the driving force of the drive control device 4 comes from the compressed gas provided by the plunger mechanism. The plunger mechanism ensures the same intake volume each time, ensures the stability and repeatable accuracy of the system, and can achieve the precise output of compressed gas with micron-level accuracy. The gas volume is precisely controlled through the plunger mechanism, avoiding the problem that the intake volume of traditional air compressors is difficult to control.

[0186] The drive control device 4 sends the compressed gas to the ventricular cavity 1-3 through the connecting air pipe, applies pressure to the liquid in the ventricular cavity 1-3, and makes the bionic ventricle 1-1 contract and expand periodically, so as to precisely simulate the heartbeat.

[0187] In one embodiment, referring to Figure 12 , the power and transmission unit includes a power unit having a servo motor 4-1, a coupling 4-2 and a ball screw 4-3, and a transmission unit having a ball slide 4-4 and a push rod clamp 4-5.

[0188] One end of the screw rod of the ball screw 4-3 is connected to the motor shaft of the servo motor 4-1 through the coupling 4-2. The nut of the ball screw 4-3 is connected to the ball slide 4-4. The ball slide 4-4 serves as the linear motion end and is connected to the other end of the syringe plunger 4-6 through the push rod clamp 4-5. The power unit adopts a high-precision transmission pair to ensure linear motion control with low hysteresis and high response.

[0189] During specific implementation, when the push rod clamp 4-5 is connected to the syringe plunger 4-6, a bolt group is used to form a rigid connection to achieve high-stability thrust transmission.

[0190] In one embodiment, the coupling 4-2 adopts an elastic coupling.

[0191] In one embodiment, the ball screw 4-3 adopts a preloaded ball screw.

[0192] In one embodiment, referring to Figure 12 , the drive control device 4 further includes a control unit. The control unit adopts a three-level architecture, including a servo driver, a motion control card and an industrial computer connected in sequence. The servo driver is connected to the control end of the servo motor 4-1.

[0193] The control unit realizes micron-level motion control with high real-time performance based on the EtherCAT bus protocol.

[0194] In one embodiment, a displacement curve of the syringe push rod is preset in the industrial control computer. The industrial control computer converts the displacement curve of the syringe push rod into a motor drive signal, and dynamically adjusts the linear motion of the syringe push rod 4-6 through a preset closed-loop PID algorithm to ensure precise control of the gas output. As the power and transmission unit drives the ball screw 4-3 to drive the syringe push rod 4-6 to move according to the displacement curve of the syringe push rod, the syringe volume in the syringe sleeve 4-7 is dynamically compressed, and the generated compressed gas enters the ventricular cavity 1-3 through the connecting air pipe, applying a periodic pressure to the liquid in the ventricular cavity 1-3, thereby triggering the bionic ventricle 1-1 to simulate pulsation. This system can reproduce the hemodynamic characteristics of the heart with high precision and realize the simulation of the heart pumping process.

[0195] In one embodiment, to accurately simulate the pulsation characteristics of the heart, the displacement curve of the syringe push rod is obtained in the following way: Use a neural network model to train the relationship between the motion of the syringe push rod 4-6 and related inputs to generate the displacement curve of the syringe push rod.

[0196] The related inputs in this embodiment are such as pressure and / or flow rate, etc. As Figure 13 and Figure 14 shown, a large amount of experimental data can be used to train the neural network model to enable it to learn the complex relationship between the motion of the syringe push rod 4-6 and related inputs (such as pressure and / or flow rate, etc.), thereby generating an optimized displacement curve of the syringe push rod. Convert this displacement curve of the syringe push rod into a motor drive signal, and use the power and transmission unit as a drive module to drive the servo motor.

[0197] In one embodiment, to accurately simulate the pulsation characteristics of the heart, the displacement curve of the syringe push rod is obtained in the following way: Use the law of the change of the heart volume with the cardiac cycle in medicine to convert it into the displacement curve of the syringe push rod.

[0198] As Figure 15 and Figure 16 shown, through the medical ventricular volume change data, the law of the change of the heart volume with the cardiac cycle in medicine is obtained, and it is converted into the displacement curve of the syringe push rod to guide the motion of the syringe push rod 4-6. The control unit converts the displacement curve of the syringe push rod into a motor drive signal and adjusts the displacement of the syringe push rod in real time through PID feedback to precisely control the motion of the push rod. Among them, Figure 16 the syringe volume feedback refers to determining the current sleeve volume of the syringe sleeve 4-7 as the syringe volume feedback information through the angular position information of the servo motor 4-1.

[0199] In one embodiment, referring to Figure 7, the initial volume setting process of the ventricular simulator 1 is as follows:

[0200] Start the external drive system, set the initial ventricular volume target value as the target ventricular volume. Determine the current sleeve volume (also known as the piston chamber volume) of the syringe barrel 4-7 through the angular position information of the servo motor 4-1. Calculate the current ventricular volume (also known as the existing ventricular volume) based on the relationship between the sleeve volume and the ventricular volume, and compare the current ventricular volume with the target ventricular volume. If the current ventricular volume is less than the target ventricular volume, reduce the air volume in the ventricular cavity 1-3 by retracting the syringe plunger 4-6, thereby increasing the current ventricular volume of the bionic ventricle 1-1 until the target ventricular volume is reached. If the current ventricular volume is greater than the target ventricular volume, increase the air volume in the ventricular cavity 1-3 by pushing the syringe plunger 4-6, thereby reducing the current ventricular volume of the bionic ventricle 1-1 until the target ventricular volume is reached. Until the initial volume of the final bionic ventricle 1-1 reaches the target ventricular volume.

[0201] In this embodiment, the servo motor 4-1 is preferably a servo motor with a built-in encoder, and the angular position information can be obtained by converting the value of the encoder.

[0202] In one embodiment, the actuator further includes one or several support structures. The support structure includes a support frame and a V-shaped positioning fixture fixed on the support frame. The V-shaped positioning fixture supports on the outer peripheral surface of the syringe barrel 4-7.

[0203] Preferably, V-shaped positioning fixtures are arranged symmetrically before and after on the outer circumference of the syringe barrel 4-7 to ensure high-precision centering of the movement of the plunger mechanism.

[0204] In one embodiment, the connecting air pipe adopts an anti-turbulence air pipe.

[0205] In one embodiment, referring to Figure 10 , the aortic valve simulator 2, as a one-way valve device for the artificial heart valve, includes an aortic valve connector 2-1, an aortic valve support 2-2, and a bionic aortic valve 2-3.

[0206] The aortic valve connector 2-1 has a connector through hole penetrating from front to back. The aortic valve connector 2-1 is sleeved outside the bionic aortic valve 2-3. One side of the aortic valve connector 2-1 is detachably connected to the aortic valve support 2-2, and the other side of the aortic valve connector 2-1 is connected to the arterial compliance simulation device 5 through a pipeline.

[0207] The aortic valve support 2-2 has a support through hole penetrating from front to back. One side of the aortic valve support 2-2 is hermetically connected to the bionic aortic valve 2-3, and the other side of the aortic valve support 2-2 is hermetically connected to the front side of the ventricular simulator 1.

[0208] In one embodiment, referring to Figure 11 , the mitral valve simulator 3, as a one-way valve device imitating a heart valve, includes a mitral valve connector 3-1, a mitral valve support 3-2, and a bionic mitral valve 3-3.

[0209] The mitral valve connector 3-1 has a connector through-hole penetrating from front to back. The mitral valve connector 3-1 is sleeved outside the bionic mitral valve 3-3. One side of the mitral valve connector 3-1 is detachably connected to the mitral valve support 3-2, and the other side of the mitral valve connector 3-1 is connected to the venous atrium simulator 7 through a pipeline.

[0210] The mitral valve support 3-2 has a support through-hole penetrating from front to back. One side of the mitral valve support 3-2 is hermetically connected to the bionic mitral valve 3-3, and the other side of the mitral valve support 3-2 is hermetically connected to the rear side of the ventricle simulator 1.

[0211] In one embodiment, the bionic aortic valve 2-3 is hermetically connected to the aortic valve support 2-2 through a medical-grade adhesive.

[0212] In one embodiment, the bionic mitral valve 3-3 is hermetically connected to the mitral valve support 3-2 through a medical-grade adhesive.

[0213] In one embodiment, the aortic valve connector 2-1 and the aortic valve support 2-2 are reversibly assembled by screw connection.

[0214] At this time, the aortic valve support 2-2 can adopt an aortic valve support 2-2 with a standard screw interface.

[0215] In one embodiment, the mitral valve connector 3-1 and the mitral valve support 3-2 are reversibly assembled by screw connection.

[0216] At this time, the mitral valve support 3-2 can adopt a mitral valve support 3-2 with a standard screw interface.

[0217] In one embodiment, referring to Figure 10 , when assembling the aortic valve simulator 2, align the three valve gaps of the bionic aortic valve 2-3 with the three brackets on the aortic valve support 2-2. Apply silicone glue at the connection between the bionic aortic valve 2-3 and the aortic valve support 2-2, and wait for it to cure for 5 minutes - 15 minutes, preferably 10 minutes, to ensure the firmness and stability of the connection. Finally, screw-tighten the aortic valve support 2-2 and the aortic valve connector 2-1 to which the bionic aortic valve 2-3 has been connected to ensure the fixation and normal operation of the entire valve system in the simulator.

[0218] In one embodiment, referring to Figure 11When assembling the mitral valve simulator 3, align the three valve gaps of the bionic mitral valve 3-3 with the three brackets on the mitral valve support 3-2. Apply silicone glue at the connection between the bionic mitral valve 3-3 and the mitral valve support 3-2, and wait for it to cure for 5 to 15 minutes, preferably 10 minutes, to ensure the firmness and stability of the connection. Finally, fasten the mitral valve support 3-2 and the mitral valve connector 3-1, to which the bionic mitral valve 3-3 has been connected, by threading to ensure the fixation and normal operation of the entire valve system in the simulator.

[0219] In one embodiment, referring to Figure 1 a pressure detection channel communicating inside and outside is provided in the middle of the bionic aortic valve 2-3, and a pressure detection interface is provided at the end of the pressure detection channel. The pressure detection interface is connected to the left ventricular pressure sensor 9-2 to realize real-time monitoring of the ventricular pressure.

[0220] In one embodiment, both the bionic aortic valve 2-3 and the bionic mitral valve 3-3 are silicone valves made of silicone material.

[0221] Both the bionic aortic valve 2-3 and the bionic mitral valve 3-3 are preferably silicone valves made of AB silicone material with performance similar to that of human heart valve tissue in a volume ratio of 1:1.

[0222] Both the bionic aortic valve 2-3 and the bionic mitral valve 3-3 are more preferably silicone valves made of Ecoflex 0030 platinum-catalyzed silicone material to ensure their excellent flexibility and biocompatibility.

[0223] In one embodiment, the bionic aortic valve 2-3 and the bionic mitral valve 3-3 are designed as follows:

[0224] According to the shape and functional characteristics of the three-leaf valve of the human heart, design a bionic valve. The bionic valve includes three valves to ensure a high degree of simulation in structure and function. The elastic modulus of the valve matches that of the human valve to ensure smooth opening and circulation under extremely low pressure differences, effectively reducing the hydraulic shock phenomenon and improving the stability and accuracy of the system operation.

[0225] In one embodiment, the diameter of the bionic valve is 20 mm - 25 mm, and the thickness is 0.7 mm - 0.9 mm. The thickness is preferably 0.8 mm.

[0226] In one embodiment, referring to Figure 9 the bionic aortic valve 2-3 and the bionic mitral valve 3-3 are manufactured as follows:

[0227] The required valve mold is made using stereolithography 3D printing technology, usually having an upper mold 2-3-1 and a lower mold 2-3-2. A mold release agent is evenly sprayed on the surface of the valve mold and left to stand to ensure that the mold surface is smooth and easy to demold. Prepare a mixed solution and stir it evenly. Preferably, before pouring it into the valve mold, the air bubbles in the mixed solution are removed by a vacuum pump to ensure the purity and quality of the mixed solution. Then, the bubble-free mixed solution is poured into the lower mold 2-3-2 of the valve mold. Close the upper mold 2-3-1 of the valve mold and place the valve mold in an oven for baking. After the valve mold cools down, take it out and open the valve mold to obtain a bionic valve.

[0228] The mixed solution in the above manufacturing process is preferably a silicone liquid. Preferably, an AB silicone material with properties similar to those of human heart valve tissue is used and mixed evenly at a volume ratio of 1:1. More preferably, an Ecoflex0030 platinum-catalyzed silicone material is selected to ensure its excellent flexibility and biocompatibility.

[0229] In specific implementation, a mold release agent is evenly sprayed on the surface of the valve mold and left to stand for 15 to 20 minutes to ensure that the mold surface is smooth and easy to demold.

[0230] In specific implementation, the valve mold is placed in an oven, the temperature is set to 50°C - 70°C, preferably 60°C, and baked for 10 to 30 minutes, preferably 20 minutes.

[0231] In one embodiment, referring to Figure 17 , the arterial compliance simulation device 5 includes an integrated bionic cavity 5-1 having an integrally formed lower base 5-1a and an upper adjustment chamber 5-1b, a displacement sensor 5-2, a delivery air pipe 5-3, and a pressure adjustment mechanism including an electromagnetic valve 5-4, a pressure reducing valve 5-5, and a pressure gas cylinder 5-6 that are sequentially connected through pipelines.

[0232] Two pipeline interfaces that are internally and externally connected are provided on the lower base 5-1a. One pipeline interface is connected to the aortic valve simulator 2 through a pipeline, and the other pipeline interface is connected to the vascular resistance simulator 6 through a pipeline. The two pipeline interfaces preferably adopt standard pipeline interfaces to achieve rapid sealed connection with the extracorporeal circulation pipeline.

[0233] A transmission window and an air pipe connection interface that is internally and externally connected are provided on the upper part of the upper adjustment chamber 5-1b. A non-contact measurement environment is constructed through the transmission window.

[0234] The displacement sensor 5-2 is installed on the top of the upper adjustment chamber 5-1b, and the detection end of the displacement sensor 5-2 faces the transmission window. The displacement sensor 5-2 monitors the displacement amount of the gas-liquid interface in the upper adjustment chamber 5-1b in real time through the transmission window. The displacement sensor 5-2 preferably adopts a high-precision laser displacement sensor.

[0235] One interface of the solenoid valve 5-4 is connected to the gas pipe connection interface through the delivery gas pipe 5-3, so that the pressure gas cylinder 5-6 is internally connected to the upper adjustment chamber 5-1b via the pressure reducing valve 5-5 and the solenoid valve 5-4 through the delivery gas pipe 5-3. The other interface of the solenoid valve 5-4 is communicated with the external atmospheric environment. As a result, the solenoid valve 5-4 forms a three-way solenoid valve. That is to say, the upper adjustment chamber 5-1b can be connected to the external atmospheric environment or the pressure gas cylinder 5-6. The solenoid valve 5-4 can adjust the gas discharge or pressurization according to the real-time data fed back by the displacement sensor 5-2, precisely control the air volume in the upper adjustment chamber 5-1b, and thus adjust the change of vascular compliance.

[0236] In one embodiment, the integrated bionic cavity 5-1 adopts a transparent acrylic cavity.

[0237] In one embodiment, the integrated bionic cavity 5-1 is processed from biocompatible polymethyl methacrylate (PMMA) to form a composite cavity structure.

[0238] In one embodiment, the transmission window is a laser transmission window with an anti-fog coating.

[0239] In one embodiment, the pressure reducing valve 5-5 adopts a digital display pressure reducing valve.

[0240] In one embodiment, the pressure gas cylinder 5-6 adopts a medical-grade 316L stainless steel gas cylinder.

[0241] In one embodiment, the delivery gas pipe 5-3 adopts a silica gel gas pipe.

[0242] In one embodiment, the pressure regulating mechanism is composed of a pressure gas cylinder 5-6, a pressure reducing valve 5-5 and a solenoid valve 5-4 to form a three-stage pressure control chain, and provides an adjustable pressure of 0-300 mmHg to the integrated bionic cavity 5-1 through the delivery gas pipe 5-3.

[0243] In one embodiment, referring to Figure 17 , the arterial compliance simulation device 5 further includes a gas cylinder fixing device 5-7, and the gas cylinder fixing device 5-7 connects and supports the pressure gas cylinder 5-6.

[0244] In one embodiment, referring to Figure 17 , the arterial compliance simulation device 5 further includes a solenoid valve support 5-8, and the solenoid valve support 5-8 connects and supports the solenoid valve 5-4.

[0245] In one embodiment, referring to Figure 1 and Figure 3 , a branch pipe joint is provided on the pipeline where the arterial compliance simulation device 5 is connected to the aortic valve simulator 2, and the branch pipe joint is connected to the aortic pressure sensor 9-1.

[0246] The solenoid valve 5-4 is a solenoid valve with a PID self-tuning algorithm. The solenoid valve 5-4 adjusts the air volume in the upper adjustment chamber 5-1b in a closed-loop manner according to the detection results of the displacement sensor 5-2 and the aortic pressure sensor 9-1.

[0247] In one embodiment, the arterial compliance simulation device 5 is installed on a base, and the base is fixed to the fiberglass board of the test bench by bolts.

[0248] In one embodiment, referring to Figure 17 , the arterial compliance simulation device 5 further includes a dynamic compliance calculation module, which is built into the embedded processor 5-9. The dynamic compliance calculation module uses the air spring principle and the PID closed-loop feedback control system to achieve precise and dynamic compliance adjustment. Specifically, the dynamic compliance calculation module is used for:

[0249] Real-time monitoring of the displacement of the gas-liquid interface through the displacement sensor 5-2 via the transmission window, and converting the monitored displacement of the gas-liquid interface into a volume change ΔV through the displacement-volume calibration curve; obtaining the pressure change value ΔP detected by the aortic pressure sensor 9-1; dynamically calculating the current vascular compliance C value based on C = ΔV / ΔP, comparing the current vascular compliance C value with the preset target compliance value, calculating the deviation amount, and using the preset PID self-tuning algorithm to perform non-linear volume compensation calculation according to the deviation amount to determine the volume change amount to be adjusted; dynamically adjusting the gas volume in the upper adjustment chamber 5-1b by the solenoid valve 5-4 according to the volume change amount with a volume control accuracy of ±N mL (N is a preset value, such as 0.8) to achieve precise simulation of arterial compliance within the pathological range of 1 mL / mmHg - 2 mL / mmHg; monitoring the displacement of the gas-liquid interface and the pressure change value again, calculating the new vascular compliance C value, and evaluating the adjustment effect. If the new vascular compliance C value still does not reach the preset target compliance value, repeat the above adjustment process until the vascular compliance C value reaches the preset target compliance value.

[0250] In this embodiment, the elastic modulus of the blood vessel wall is simulated through the mechanical characteristics of the gas-liquid coupling cavity, the multi-parameter fusion detection of laser ranging and pressure sensing, and the non-linear volume compensation of the PID algorithm, constructing a triple mechanism different from the prior art. Among them, the anti-fog window design reduces errors in long-term monitoring, and the modular interface design improves the system integration efficiency.

[0251] In one embodiment, referring to Figure 18 , a specific process of the automatic adjustment method of arterial compliance is as follows:

[0252] First, start the system and perform initialization configuration to ensure the normal operation of each component.

[0253] Set parameters such as the target compliance value, pressure range, and volume change range according to the experimental requirements.

[0254] Through the intelligent pressure regulation system, using the three - stage pressure control chain composed of the pressure gas cylinder 5 - 6, pressure reducing valve 5 - 5, and solenoid valve 5 - 4, the pressure is regulated to the target range.

[0255] The displacement sensor 5 - 2 monitors the displacement of the gas - liquid interface (i.e., detects the liquid level height) in real - time through the transmission window;

[0256] Convert the monitored displacement of the gas - liquid interface into a volume change ΔV through the displacement - volume calibration curve; obtain the pressure change value ΔP detected by the aortic pressure sensor 9 - 1; dynamically calculate the initial vascular compliance C value based on the formula C = ΔV / ΔP.

[0257] Compare the calculated initial vascular compliance C value with the target compliance value to determine whether it is greater than the target compliance value. If the initial vascular compliance C value is greater than the target compliance value, the solenoid valve 5 - 4 exhausts air through the exhaust port with a volume control accuracy of NmL according to the calculated volume change. After a preset delay time, such as 0.1 s, monitor the displacement of the gas - liquid interface and the pressure change again, calculate the new vascular compliance C value, and evaluate the adjustment effect. If the new vascular compliance C value still does not reach the target value, repeat the above adjustment process until a satisfactory simulation effect is achieved. If the initial vascular compliance C value is less than the target compliance value, the solenoid valve 5 - 4 pressurizes through the pressurization port with a volume control accuracy of NmL according to the calculated volume change. After a preset delay time, such as 0.1 s, monitor the displacement of the gas - liquid interface and the pressure change again, calculate the new vascular compliance C value, and evaluate the adjustment effect. If the new vascular compliance C value still does not reach the target value, repeat the above adjustment process until a satisfactory simulation effect is achieved.

[0258] During the whole adjustment process, continuously record relevant data for subsequent analysis and optimization; when all adjustments are completed and meet the experimental requirements, turn off the system and end the operation.

[0259] In one embodiment, referring to Figure 1 and Figure 3 , an ultrasonic flow sensor 8 is installed on the pipeline connecting the arterial compliance simulator 5 and the aortic valve simulator 2.

[0260] In one embodiment, referring to Figure 19 and Figure 20 , the vascular resistance simulator 6 includes a valve plug 6 - 1, a valve body 6 - 2, and a drive motor 6 - 4.

[0261] The lower part of the valve plug 6-1 extends into the valve body 6-2 and is rotatably connected to the valve body 6-2. The bottom of the valve plug 6-1 can be closely fitted with the size of the valve body 6-2. When the bottom of the valve plug 6-1 abuts against the inner wall of the valve body 6-2, the purpose of intercepting the flow in the valve body 6-2 is achieved, so that the change range of the flow cross-sectional area can be realized from 0 to 100%.

[0262] The valve body 6-2 has a valve body through hole penetrating transversely. One side of the valve body through hole is connected to the arterial compliance simulation device 5, and the other side of the valve body through hole is connected to the venous atrium simulator 7.

[0263] The driving motor 6-4 drives the valve plug 6-1 to rotate, so that the valve plug 6-1 realizes stepless adjustment in the valve body 6-2.

[0264] In specific implementation, both the valve plug 6-1 and the valve body 6-2 are provided with spiral structures to realize the rotational connection between the two.

[0265] In one embodiment, referring to Figure 19 and Figure 20 , the vascular resistance simulator 6 further includes a valve body support 6-3, and the valve body support 6-3 supports the driving motor 6-4.

[0266] In one embodiment, a first gear is fixed on the output shaft of the driving motor 6-4, a second gear is fixed on the valve plug 6-1, the second gear is meshed and connected with the first gear, the driving motor 6-4 drives the first gear to rotate, and then drives the second gear to rotate, and finally drives the valve plug 6-1 to rotate.

[0267] In one embodiment, referring to Figure 21 , the resistance adjustment method of the vascular resistance simulator 6 is as follows:

[0268] Set the target resistance valve R value range according to the experimental requirements; drive the valve plug 6-1 to rotate to a preset initial position by the driving motor 6-4; calculate the current resistance valve R value according to the initial position, and judge whether the current resistance valve R value is greater than the target resistance valve R value range. If it is greater, drive the driving motor 6-4 to reverse, so that the valve plug 6-1 rotates in the valve body 6-2 to increase the flow cross-sectional area. If it is less, drive the driving motor 6-4 to rotate forward, so that the valve plug 6-1 rotates in the valve body 6-2 to reduce the flow cross-sectional area; calculate the new resistance valve R value again according to the rotation position of the valve plug 6-1, and judge whether the new resistance valve R value is within the target resistance valve R value range. If so, the resistance adjustment is completed, otherwise repeat the above adjustment process until the resistance valve R value is within the target resistance valve R value range.

[0269] In this embodiment, the R value of the resistance valve represents the resistance suffered during the fluid flow, which can be called the local resistance. It is the resistance caused by the sudden reduction of the pipe cross-section within the pipe (simulating the resistance generated when blood flows from a relatively thick artery to very thin capillaries in the blood vessel, representing the pressure loss). The magnitude of the R value of this resistance valve is related to the size of the flow cross-sectional area. The smaller the cross-sectional area, the greater the resistance. The calculation formula for the R value of this resistance valve can be simplified as follows:

[0270] R = (ρ / 2) * ((1 - A2 / A1)^2) * (Q / A2^2), where ρ is the fluid density, Q is the volume flow rate, A1 is the cross-sectional area before contraction, and A2 is the cross-sectional area after contraction.

[0271] The up-and-down movement of the valve plug 6-1 within the valve body 6-2 will change the flow cross-sectional area, thereby changing the R value of the resistance valve.

[0272] In this embodiment, the position of the valve plug 6-1 within the valve body 6-2 can be calculated based on the rotation angle position of the drive motor 6-4, and then the flow cross-sectional area of the valve body 6-2 can be determined and compared with the set value. The drive motor 6-4 is preferably a drive motor with an in-built encoder, and the rotation angle position information can be obtained through conversion based on the value of the encoder.

[0273] In one embodiment, the venous atrium simulator 7 includes a container. There are two internally and externally connected container interfaces at the bottom of the container for connecting pipelines. One container interface is connected to the vascular resistance simulator 6 through a pipeline, and the other container interface is connected to the mitral valve simulator 3 through a pipeline. There is an openable top cover above the container for adding simulation liquid. There is a constant temperature heating device inside the container, which can keep the simulation liquid at a constant temperature such as 37°C.

[0274] In one embodiment, the container is made of an acrylic container.

[0275] In one embodiment, the container is a cuboid container.

[0276] In one embodiment, the ventricle simulator 1 and the internal simulation liquid circulation system are arranged on the experimental bench, and the external drive system is arranged on the side of the experimental bench.

[0277] In one embodiment, referring to Figure 1 , the extracorporeal blood flow circulation simulation device further includes a control terminal 10, which integrates the operation program of the extracorporeal blood flow circulation simulation device to achieve the control of each component in the extracorporeal blood flow circulation simulation device.

[0278] In one embodiment, referring to Figure 22 , an operation process of the extracorporeal blood flow circulation simulation device is as follows:

[0279] First, open the solenoid valve 5-4 of the internal simulated liquid circulation system to connect the gas pipeline of the internal simulated liquid circulation system with the external gas environment, so as to expel the gas in the gas pipeline when adding the simulated liquid. Add the simulated liquid to the container of the venous atrium simulator 7 (i.e., the venous cavity), and then heat the simulated liquid to 37°C;

[0280] Start the drive motor 6-4 to run and expel the air bubbles inside the exhaust device and the pipeline; when the air bubbles are exhausted, turn off the drive motor 6-4, adjust the parameters of each device (vascular compliance C value, initial ventricular volume value, vascular resistance magnitude) and the input syringe plunger displacement curve (healthy or heart failure state), and then start the control terminal 10 to run the program, and read the pressure and flow data of the system at the data acquisition terminal.

[0281] Among them, the data acquisition terminal includes at least one of the aortic pressure sensor 9-1, the left ventricular pressure sensor 9-2, the ventricular cavity drive air pressure sensor 9-3, and the ultrasonic flow sensor 8.

[0282] The preferred embodiments of the present invention have been described in detail above. However, it should be understood that after reading the above teachings of the present invention, those skilled in the art can make various changes or modifications to the present invention. These equivalent forms also fall within the scope defined by the appended claims of this application.

Claims

1. A ventricular simulator, characterized in that: include: The ventricular cavity is provided with an air path interface communicating with the inside and outside; The bionic ventricle is hollow inside and has openings at both ends, can contract or expand, is transversely arranged in the ventricular cavity, and is sealed and fixed at both ends of the bionic ventricle and the ventricular cavity by a front connecting cover and a rear connecting cover, so that the interior of the bionic ventricle is separated from the ventricular cavity. The front connecting cover and the rear connecting cover are both provided with a transverse connecting port connected to the interior of the bionic ventricle.

2. The ventricular simulator according to claim 1, characterized in that The ventricular cavity is also provided with an air pressure sensor interface communicating with the inside and outside, and the air pressure sensor interface is connected to the ventricular cavity to drive the air pressure sensor; And / or, the air circuit interface on the ventricular cavity is connected to a quick-connect air circuit connector; And / or, the bionic ventricle is provided with connecting flanges at both lateral ends, and the connecting flanges at both ends are pressed and fixed to the two ends of the bionic ventricle by the front connecting cover and the rear connecting cover; And / or, the ventricular cavity is injected with liquid, and the liquid completely covers the bionic ventricle; And / or, the ventricular cavity is an acrylic ventricular cavity made of acrylic material; And / or, the bionic ventricle is a silicone ventricle made of silicone material; the bionic ventricle is preferably a silicone ventricle made of AB silicone material in a volume ratio of 1:1; the bionic ventricle is more preferably a silicone ventricle made of silicone material with a Young's modulus of 20kPa-50kPa; the bionic ventricle is most preferably a silicone ventricle made of Ecoflex 0030 platinum catalyzed silicone material; And / or, the ventricular simulator further comprises: a ventricular simulator support, supporting and fixing the ventricular cavity; And / or, the ventricular simulator bracket includes: a bottom bracket, supporting the ventricular cavity; and a top fastening bracket, fastened to the upper outer surface of the ventricular cavity and connected to and fixed to the bottom bracket.

3. The ventricular simulator according to claim 1 or 2, characterized in that: The bionic ventricle is designed in the following manner: an initial bionic ventricle is designed according to the structure and morphology of a human ventricle, and the shape of the initial bionic ventricle is designed to be a semi-ellipsoid; the initial bionic ventricle is reasonably scaled so that the volume range of the initial bionic ventricle is 180ml-240ml, wherein the size of the ellipsoid of the initial bionic ventricle is preferably 35mm×35mm×45mm; And / or, the bionic ventricle is made in the following manner: a bionic ventricle mold is made using additive manufacturing technology, including a left mold, a right mold and an inner mold; the left mold and the right mold are connected, the outer diameter of the inner mold is consistent with the inner diameter of the bionic ventricle, and the inner diameters of the left mold and the right mold are consistent with the outer diameter of the bionic ventricle; a release agent is sprayed on the surface of the bionic ventricle mold, and after standing, a mixed liquid is prepared according to the designed volume of the bionic ventricle, and stirred evenly; in order to eliminate bubbles, it is preferred to extract the bubbles in the mixed liquid by a vacuum pump before pouring it into the bionic ventricle mold, and then pour the bubble-free mixed liquid into the bionic ventricle mold; in order to ensure that the mixed liquid fills the bionic ventricle mold and the bubbles are completely discharged, it is preferably injected through a syringe, and the bionic ventricle mold filled with the mixed liquid is placed in a vacuum environment again for degassing; finally, the bionic ventricle mold is placed in an oven for baking, and after the bionic ventricle mold is cooled, it is taken out and disassembled to obtain a bionic ventricle.

4. An extracorporeal blood circulation simulation device simulating heart beat, characterized in that: include: A ventricular simulator as claimed in any one of claims 1 to 3; An external drive system, comprising a drive control device, the drive control device being connected to the gas path interface of the ventricular cavity via a gas path, the drive control device providing compressed gas to the ventricular cavity; The internal simulated liquid circulation system comprises an aortic valve simulator, an arterial compliance simulator, a vascular resistance simulator, a venous atrium simulator and a mitral valve simulator which are sequentially connected via pipelines. The aortic valve simulator is connected to the front side of the ventricular simulator and is unidirectionally connected to the interior of the bionic ventricle. The mitral valve simulator is connected to the back side of the ventricular simulator and is unidirectionally connected to the interior of the bionic ventricle.

5. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 4, characterized in that: The drive control device comprises: A power and transmission unit having a linear motion end; An actuator, comprising a plunger mechanism, the plunger mechanism comprising a syringe sleeve and a syringe push rod, one end of the syringe sleeve is provided with a compressed gas outlet, the compressed gas outlet is connected to the gas path interface of the ventricular cavity through a connecting trachea, one end of the syringe push rod extends into the other end of the syringe sleeve, the other end of the syringe push rod is connected to the linear motion end, the power and transmission unit drives one end of the syringe push rod to perform linear motion in the syringe sleeve, so that the compressed gas in the syringe sleeve is delivered to the ventricular cavity through the connecting trachea; Preferably, the power and transmission unit comprises: Servo motor; A ball screw, one end of which is connected to the motor shaft of the servo motor via a coupling; A ball slide, connected to the nut of the ball screw, as a linear motion end connected to the other end of the syringe push rod through a push rod clamp; More preferably, the drive control device further comprises: A control unit, comprising a servo driver, a motion control card and an industrial computer connected in sequence, wherein the servo driver is connected to a control end of the servo motor; More preferably, the industrial computer is preset with a syringe push rod displacement curve, and the syringe push rod displacement curve is converted into a motor drive signal by the industrial computer, and the linear motion of the syringe push rod is dynamically adjusted by a preset closed-loop PID algorithm; More preferably, the syringe push rod displacement curve is obtained in the following manner: The relationship between the motion of the syringe push rod and the relevant input is trained using a neural network model to generate a syringe push rod displacement curve; Or, using the medical law that the volume of the heart changes with the cardiac cycle, it can be converted into a syringe push rod displacement curve; More preferably, the initial volume setting process of the ventricular simulator is: Starting the external driving system and setting the target value of the initial ventricular volume as the target ventricular volume; Determine the current sleeve volume of the syringe sleeve through the rotation angle position information of the servo motor, calculate the current ventricular volume according to the relationship between the sleeve volume and the ventricular volume, and compare the current ventricular volume with the target ventricular volume; If the current ventricular volume is smaller than the target ventricular volume, the air volume in the ventricular cavity is reduced by withdrawing the syringe push rod, thereby increasing the current ventricular volume of the bionic ventricle until the target ventricular volume is reached; If the current ventricular volume is greater than the target ventricular volume, the air volume in the ventricular cavity is increased by advancing the syringe push rod, thereby reducing the current ventricular volume of the bionic ventricle until the target ventricular volume is reached; Preferably, the actuator further comprises: One or more supporting structures, the supporting structure comprising a supporting frame and a V-shaped positioning fixture fixed on the supporting frame, the V-shaped positioning fixture being supported on the outer peripheral surface of the syringe sleeve; Preferably, the connecting air pipe is an anti-turbulence air pipe.

6. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 4, characterized in that: The aortic valve simulator and the mitral valve simulator as one-way valve devices simulating heart valves both include: Bionic valve, the bionic valve of the aortic valve simulator is a bionic aortic valve, and the bionic valve of the mitral valve simulator is a bionic mitral valve; A valve support having a support through hole extending through the front and back, one side of which is sealed and connected to the bionic valve, and the other side of which is sealed and connected to the ventricular simulator; A connector, having a connector through hole penetrating the front and back, is sleeved outside the bionic valve, one side of which is detachably connected to the valve support, the other side of the connector of the aortic valve simulator is connected to the arterial compliance simulation device through a pipeline, and the other side of the connector of the mitral valve simulator is connected to the venous atrium simulator through a pipeline; Preferably, the bionic valve is sealed and connected to the corresponding valve support by a medical grade adhesive; Preferably, the connector and the valve support are reversibly assembled by threaded connection; Preferably, a pressure detection channel communicating with the inside and outside is provided in the middle of the bionic aortic valve, and a pressure detection interface is provided at the end of the pressure detection channel, and the pressure detection interface is connected to the left ventricular pressure sensor; Preferably, the bionic valve is a silicone valve made of silicone material; the bionic valve is preferably a silicone valve made of AB silicone material in a volume ratio of 1:1; the bionic valve is more preferably a silicone valve made of Ecoflex 0030 platinum catalyzed silicone material; Preferably, the bionic valve is designed in the following manner: According to the shape and functional characteristics of the three-leaf valve of the human heart, a bionic valve is designed, wherein the bionic valve comprises three valves, and the elastic modulus of the valve matches that of the human valve; Preferably, the bionic valve has a diameter of 20 mm to 25 mm and a thickness of 0.7 mm to 0.9 mm, and the thickness is preferably 0.8 mm; Preferably, the bionic valve is manufactured in the following manner: The required valve mold is made by using light-curing 3D printing technology, and a release agent is evenly sprayed on the surface of the valve mold and allowed to stand; Prepare a mixed liquid, stir it evenly, preferably extract bubbles in the mixed liquid by a vacuum pump before pouring it into the valve mold, and then pour the bubble-free mixed liquid into the valve mold; The valve mold is closed and placed in an oven for baking. After the valve mold is cooled, the valve mold is taken out and opened to obtain a bionic valve.

7. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 4, characterized in that: The arterial compliance simulation device comprises: The integrated bionic cavity has an integrally manufactured lower base and an upper regulating cabin, the lower base is provided with two pipeline interfaces communicating with each other, one of the pipeline interfaces is connected to the aortic valve simulator through a pipeline, and the other pipeline interface is connected to the vascular resistance simulator through a pipeline, and the upper part of the upper regulating cabin is provided with a transmission window and a trachea connection interface communicating with each other; A displacement sensor, mounted on the top of the upper regulating cabin, with a detection end facing the transmission window; The pressure regulating mechanism comprises a solenoid valve, a pressure reducing valve and a pressure gas cylinder which are sequentially connected through pipelines, wherein one interface of the solenoid valve is connected to the gas pipe connecting interface through a gas delivery pipe, and another interface of the solenoid valve is connected to the external atmospheric environment; Preferably, the integrated bionic cavity is a transparent acrylic cavity; Preferably, the integrated bionic cavity is processed by biocompatible polymethyl methacrylate to form a composite cavity structure; Preferably, the transmission window is a laser transmission window with an anti-fog coating; Preferably, the pressure reducing valve is a digital display pressure reducing valve; Preferably, the pressure gas cylinder is a medical grade 316L stainless steel gas cylinder; Preferably, the delivery air pipe is a silicone air pipe; Preferably, the pressure regulating mechanism provides 0-300 mmHg adjustable pressure to the integrated bionic cavity through the air delivery pipe; Preferably, the arterial compliance simulation device further comprises: A gas cylinder fixing device, connected to and supporting the pressure gas cylinder; Preferably, the arterial compliance simulation device further comprises: The solenoid valve support is connected to and supports the solenoid valve.

8. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 7, characterized in that: A branch pipe joint is provided on the pipeline connecting the arterial compliance simulation device and the aortic valve simulator, and the branch pipe joint is connected to the aortic pressure sensor; The solenoid valve adopts a solenoid valve with a PID self-tuning algorithm, and the solenoid valve adjusts the air volume in the upper regulating cabin through closed-loop feedback according to the detection results of the displacement sensor and the detection results of the aortic pressure sensor; Preferably, the arterial compliance simulation device further comprises a dynamic compliance calculation module, and the dynamic compliance calculation module is used for: The displacement sensor is used to monitor the displacement of the gas-liquid interface in real time through the transmission window, and the monitored displacement of the gas-liquid interface is converted into a volume change ΔV through a displacement-volume calibration curve; the pressure change value ΔP detected by the aortic pressure sensor is obtained; the current vascular compliance C value is dynamically calculated based on C=ΔV / ΔP, the current vascular compliance C value is compared with a preset target compliance value, and a deviation is calculated; according to the deviation, a nonlinear volume compensation calculation is performed using a preset PID self-tuning algorithm to determine the volume change that needs to be adjusted; The solenoid valve dynamically adjusts the gas volume in the upper regulating chamber according to the volume change with a volume control accuracy of ±NmL; the gas-liquid interface displacement and pressure change value are monitored again, a new vascular compliance C value is calculated, and the regulating effect is evaluated. If the new vascular compliance C value still does not reach the preset target compliance value, the above regulating process is repeated until the vascular compliance C value reaches the preset target compliance value; Wherein, N is a preset value; Preferably, an ultrasonic flow sensor is installed on the pipeline connecting the arterial compliance simulation device and the aortic valve simulator.

9. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 4, characterized in that: The vascular resistance simulator comprises: A valve body having a transversely penetrating valve body through hole, one side of the valve body through hole being connected to the arterial compliance simulation device, and the other side of the valve body through hole being connected to the venous atrium simulator; The valve plug has a lower portion extending into the valve body and rotatably connected to the valve body, and a bottom that can closely match the size of the valve body; A driving motor drives the valve plug to rotate, so that the valve plug can be infinitely adjusted in the valve body; Preferably, a first gear is fixed on the output shaft of the driving motor, a second gear is fixed on the valve plug, the second gear is meshedly connected with the first gear, the driving motor drives the first gear to rotate, and then drives the second gear to rotate, and finally drives the valve plug to rotate; Preferably, the resistance adjustment method of the vascular resistance simulator is: A target resistance valve R value range is set according to experimental requirements; the valve plug is driven to rotate to a preset initial position by the drive motor; the current resistance valve R value is calculated according to the initial position to determine whether the current resistance valve R value is greater than the target resistance valve R value range; if so, the drive motor is driven to reverse to rotate the valve plug within the valve body to increase the flow cross-sectional area; if less than, the drive motor is driven to rotate forward to rotate the valve plug within the valve body to reduce the flow cross-sectional area; a new resistance valve R value is calculated again according to the rotation position of the valve plug to determine whether the new resistance valve R value is within the target resistance valve R value range; if so, the resistance adjustment is completed; otherwise, the above adjustment process is repeated until the resistance valve R value is within the target resistance valve R value range.

10. The extracorporeal blood circulation simulation device for simulating heart beats as claimed in claim 4, characterized in that: The venous atrial simulator comprises: The container has two container interfaces for connecting pipelines and communicating with each other at the bottom, one of which is connected to the vascular resistance simulator through a pipeline, and the other is connected to the mitral valve simulator through a pipeline. An openable and closable top cover is provided on the top of the container, and a constant temperature heating device is provided inside the container; Preferably, the container is an acrylic container; Preferably, the container is a rectangular container.

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