Ventricular simulation device and extracorporeal emulated cardiopulmonary circulation simulation system

Abstract

The utility model relates to medical instrument technical field provides a kind of ventricle simulation device and extracorporeal bionic heart-lung circulation simulation system, the ventricle base inside structure in ventricle simulation device has the first cavity and the second cavity of intercommunication, the first cavity is equipped with first opening and second opening, and the second cavity is equipped with gas passage;Bionic ventricle sac is equipped in the first cavity, and it is equipped with liquid inlet and liquid outlet, and liquid inlet and liquid outlet are communicated with extracorporeal circulation loop respectively to simulate ventricle, and liquid inlet is communicated with first opening, and liquid outlet is communicated with second opening;Volume detection component in detection adjusting assembly is equipped in ventricle base, and it is used for detecting the volume of bionic ventricle sac according to displacement change;Pressure sensor is equipped in the second cavity, and pressure sensor is used to collect the pressure value corresponding to the capsule wall tension of bionic ventricle sac;Pressure regulating component is communicated with gas passage, for adjusting the pressure in the second cavity, so that bionic ventricle sac occurs deformation, to simulate the systole and diastole process of heart.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a ventricular simulation device and an in vitro biomimetic cardiopulmonary circulation simulation system. Background Technology

[0002] In vitro biomimetic cardiopulmonary circulation simulation systems are key devices used to simulate human blood circulation function, playing an irreplaceable role in the research, testing, and evaluation of high-end medical devices such as artificial hearts, artificial valves, and ventricular assist devices. Among these, the ventricular simulator, as the core component of the system, directly affects the simulation accuracy of the hemodynamic environment and is crucial for evaluating the functional adaptability of the ventricular simulator under different physiological states. Specifically, by accurately simulating key physiological parameters such as heart rate, cardiac output, and ventricular volume, diverse hemodynamic scenarios can be constructed, providing reliable technical support for the performance verification of the ventricular simulator.

[0003] Currently, Chinese patent publication number CN105261274B discloses a piston-type ventricular simulator for an in vitro circulatory system. It employs a constant-force spring connecting the piston to a linear motor, simulating the diastolic and contractile processes of the ventricle by controlling the motor's movement. While this approach achieves active control, it struggles to dynamically match the passive filling process of the ventricle under physiological conditions, leading to discrepancies between the simulated hemodynamic environment and actual physiological states.

[0004] Chinese patent publication number CN110648580A discloses an experimental device for simulating left ventricular function, which uses a slide table to drive a piston in reciprocating motion to simulate ventricular contraction and relaxation. Although the device improves the accuracy of motion control through a servo motor, it cannot obtain key parameters such as ventricular end-diastolic volume (EDV), thus making it difficult to realistically simulate the Frank-Starling mechanism (i.e., the physiological regulation of cardiac pumping function with changes in filling degree) between myocardial contractility and end-diastolic volume, limiting its application in myocardial mechanical property research and device adaptability evaluation.

[0005] In summary, there are still technological gaps in the passive filling process of existing ventricular simulation devices. Utility Model Content

[0006] This invention provides a ventricular simulation device and an in vitro biomimetic cardiopulmonary circulation simulation system to solve the above-mentioned technical defects in the prior art. Through the biomechanical matching of the silicon capsule, the physiological limitation of volume constraint, and the passive drive design of the pneumatic proportional valve, the systolic-diastolic mechanism and Frank-Starling mechanism of the natural ventricle are reproduced.

[0007] The first aspect of this utility model provides a ventricular simulation device, comprising:

[0008] The ventricular base has an internal structure with a first cavity and a second cavity that are interconnected. The first cavity has a first opening and a second opening, and the second cavity has a gas passage.

[0009] A biomimetic ventricular capsule is disposed in the first cavity. The biomimetic ventricular capsule has an inlet and an outlet. The inlet and the outlet are respectively connected to the extracorporeal circulation loop to simulate the ventricle. The inlet is connected to the first opening, and the outlet is connected to the second opening.

[0010] The detection and adjustment components include:

[0011] A volume detection component is disposed on the ventricular base and is used to detect the volume of the bionic ventricular capsule based on displacement changes;

[0012] A pressure sensor is disposed in the second cavity, and the pressure sensor is used to collect the pressure value corresponding to the wall tension of the bionic ventricular capsule;

[0013] A pressure regulating component, connected to the gas channel, is used to regulate the pressure within the second cavity to cause the bionic ventricular capsule to deform, thereby simulating the contraction and relaxation process of the heart.

[0014] According to the ventricular simulation device provided by this utility model, the stiffness of the bionic ventricular capsule is configured as follows:

[0015] Within the normal operating range, the stiffness of the bionic ventricular capsule changes slowly with volume;

[0016] When the bionic ventricular capsule contracts to the minimum volume critical value or relaxes to the maximum volume critical value, the stiffness of the bionic ventricular capsule increases rapidly with the volume, limiting the further change in the volume of the bionic ventricular capsule.

[0017] According to the ventricular simulation device provided by this utility model, the bionic ventricular capsule includes a first layer, a second layer and a third layer from the inside out;

[0018] The first layer has a Shore hardness of 00-10 and an elastic modulus of 5-10 kPa;

[0019] The third layer has a Shore hardness of A25 and an elastic modulus of 50-100 kPa.

[0020] The Shore hardness of the second layer is between that of the first layer and the third layer.

[0021] According to the ventricular simulation device provided by this utility model, the volume detection component includes a magnetostrictive displacement sensor, the effective stroke of which is 0 mm to 125 mm.

[0022] According to the ventricular simulation device provided by this utility model, the magnetostrictive displacement sensor includes:

[0023] The detection body is located on top of the ventricular base;

[0024] The waveguide wire is fixed along the axial direction of the second cavity;

[0025] A float is disposed on the waveguide wire and embedded at the top center of the bionic ventricular capsule, for axial movement along the waveguide wire as the liquid level changes; the float is provided with a magnetic component.

[0026] According to the ventricular simulation device provided by this utility model, the density of the float is the same as the density of the simulated blood in the bionic ventricular capsule, so that the displacement of the float as it rises and falls with the liquid level is linearly related to the actual volume change of the bionic ventricular capsule.

[0027] According to the ventricular simulation device provided by this utility model, the pressure sensor has a measurement range of -150mmHg to 300mmHg.

[0028] According to the ventricular simulation device provided by this utility model, the pressure regulating component includes a pneumatic directional proportional valve;

[0029] The pneumatic directional proportional valve has an air inlet and an air outlet. The air inlet is adapted to be connected to a compressed air source, and the air outlet is connected to the gas channel. The pneumatic directional proportional valve is used to adjust the pressure in the second cavity so that the bionic ventricular capsule can perform contraction and relaxation.

[0030] According to the ventricular simulation device provided by this utility model, the ventricular base includes:

[0031] The first body;

[0032] The second seat is vertically mounted on the first seat;

[0033] The first cavity is located inside the first seat, and the second cavity is located inside the second seat.

[0034] The second aspect of this utility model provides an in vitro biomimetic cardiopulmonary circulation simulation system, including a control module, a gas exchange module, a circulation pipeline, and a ventricular simulation device as described in any one of the above.

[0035] The ventricular simulation device is used to simulate the contraction and relaxation of the heart and drive the blood simulation fluid to flow in the circulation pipeline.

[0036] The gas exchange module is used to simulate the exchange of oxygen and carbon dioxide in the lungs, maintaining the oxygenation and acid-base balance of the simulated blood solution.

[0037] The circulation pipeline is connected to the ventricular simulation device and the gas exchange module respectively, and is used to simulate blood flow;

[0038] The control module is electrically connected to both the ventricular simulation device and the gas exchange module.

[0039] The ventricular simulation device provided by this invention reproduces the systolic-diastolic mechanism and Frank-Starling mechanism of the natural ventricle through biomechanical matching of the silicon capsule, physiological limitation of volume constraint, and passive drive design of pneumatic proportional valve. It provides a high-fidelity and controllable simulation tool for cardiovascular disease research, artificial organ development, and medical education.

[0040] Specifically, the passive filling controlled by the pneumatic directional proportional valve is more in line with the natural ventricular mechanism. Compared to the traditional forced filling mode driven by an active piston, the ventricular simulation device provided by this invention uses the pneumatic directional proportional valve to output positive pressure (inflation) or negative pressure (exhaust) to drive the bionic ventricular capsule to undergo passive deformation: when the proportional valve outputs positive pressure, compressed air enters the second chamber, increasing the pressure inside the second chamber and squeezing the bionic ventricular capsule to contract. When the pneumatic directional proportional valve switches to negative pressure, the pressure inside the second chamber decreases, and the bionic ventricular capsule relaxes under its own elastic restoring force, allowing liquid to flow from the circuit into the bionic ventricular capsule, simulating the diastolic filling process of the heart.

[0041] Real-time feedback from the volume detection component (magnetostrictive displacement sensor) and pressure sensor, combined with the high-precision adjustment of the pneumatic proportional valve, enables closed-loop control of volume, pressure, and flow. For example, in simulating heart failure (decreased ventricular compliance), the stiffness of the biomimetic ventricular capsule can be increased (simulating fibrosis), while the maximum filling volume is limited by the proportional valve. The leftward shift of the pressure-volume curve (decreased contractility) can be observed, providing a quantifiable and controllable experimental platform for studying the pathological mechanisms of heart failure.

[0042] The extracorporeal biomimetic cardiopulmonary circulation simulation system provided by this utility model includes the aforementioned ventricular simulation device, and therefore possesses all the advantages of the aforementioned ventricular simulation device. Attached Figure Description

[0043] To more clearly illustrate the technical solutions in this utility model or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this utility model. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0044] Figure 1 This is a schematic diagram of the ventricular simulation device provided in an embodiment of the present invention.

[0045] Figure 2 This is a schematic diagram of the structure of the bionic ventricular capsule in the ventricular simulation device provided in this embodiment of the utility model.

[0046] Figure label:

[0047] 10. Ventricular base; 11. First chamber; 111. First opening; 112. Second opening; 12. Second chamber; 121. Gas passage; 13. First seat; 14. Second seat;

[0048] 20. Bionic ventricular capsule; 21. Inlet; 22. Outlet;

[0049] 30. Detection and adjustment component; 31. Volume detection component; 311. Detection body; 312. Waveguide wire; 313. Float; 32. Pressure sensor; 33. Pressure adjustment component. Detailed Implementation

[0050] To make the objectives, technical solutions, and advantages of this utility model clearer, the technical solutions of this utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the protection scope of this utility model.

[0051] In the description of the embodiments of this application, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in the embodiments of this application based on the specific circumstances.

[0052] In the embodiments of this application, unless otherwise expressly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0053] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to specific features, structures, materials, or characteristics described in connection with that embodiment or example, which are included in at least one embodiment or example of the embodiments of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0054] Figure 1 This is a schematic diagram of the ventricular simulation device provided in an embodiment of the present invention.

[0055] See Figure 1 This utility model provides a ventricular simulation device, which is the core module of an in vitro biomimetic cardiopulmonary circulation system. Through the coordinated operation of multiple components, it simulates the contraction and relaxation process of the heart, and reproduces the volume changes, pressure response and Frank-Starling mechanism (positive correlation between end-diastolic volume and contractile force of the ventricle under physiological conditions.)

[0056] The ventricular simulation device includes a ventricular base 10, a bionic ventricular capsule 20, and a detection and adjustment assembly 30. Each component is precisely assembled and connected to the gas / liquid circuit to achieve functional integration.

[0057] The ventricular base 10 can be a rectangular / cylindrical cavity structure made of metal (such as aluminum alloy) or high-strength engineering plastic (such as polycarbonate). Internally, it is divided into a first cavity 11 and a second cavity 12 by a partition. The first cavity 11 and the second cavity 12 are connected through microchannels (0.5-1 mm in diameter) on the bottom or sidewall to ensure dynamic pressure transmission. In other words, the internal structure of the ventricular base 10 has an interconnected first cavity 11 and second cavity 12.

[0058] The first cavity 11 is the installation space for the bionic ventricular capsule 20. Its side wall is provided with a first opening 111 (proximal end) and a second opening 112 (distal end), which correspond to the filling inlet during diastole and the ejection outlet during systole, respectively. The opening is integrated with a sealing interface (such as an O-ring + quick connector) for connecting the extracorporeal circulation circuit.

[0059] The second cavity 12 is a pneumatic pressure acting space, and its side wall is provided with a gas channel 121, which is connected to an external pressure regulating component 33 (such as a pneumatic directional proportional valve); the inner wall of the cavity is polished to reduce the frictional resistance with the bionic ventricular capsule 20.

[0060] The biomimetic ventricular capsule 20 can be manufactured using medical-grade liquid silicone through a molding process. Its structural design strictly matches the physiological characteristics of the human ventricle: the capsule is ellipsoidal in shape with a smooth, wrinkle-free surface, simulating the natural shape of the ventricular cavity; the thickness of the capsule wall balances flexibility and tear resistance.

[0061] The top (proximal end) of the capsule is provided with an inlet 21, which is connected to the first opening 111. The bottom (distal end) is provided with an outlet 22, which is connected to the second opening 112. The interface adopts a Luer lock design to ensure a leak-free connection with the extracorporeal circulation circuit (such as pump tube, oxygenator).

[0062] The detection and adjustment assembly 30 includes a volume detection component 31, a pressure sensor 32, and a pressure adjustment component 33.

[0063] A volume detection component 31 is disposed on the ventricular base 10 and is used to detect the volume of the bionic ventricular capsule 20 based on displacement changes. The volume detection component 31 may be a magnetostrictive displacement sensor with an effective stroke of 0 mm to 125 mm.

[0064] The magnetostrictive displacement sensor includes a detection body 311, a waveguide wire 312, and a float 313. The detection body 311 is located on the top of the ventricular base 10. The waveguide wire 312 is fixed along the axial direction of the second cavity 12. The float 313 is located on the waveguide wire 312 and is embedded in the top center of the bionic ventricular capsule 20. The float 313 is equipped with a magnetic component (built-in permanent magnet).

[0065] Essentially, float 313 is positioned on the liquid surface within the bionic ventricular capsule 20, and is used to move axially along waveguide wire 312 as the liquid level changes. The volume of the bionic ventricular capsule 20 is calculated by detecting the displacement change of the magnetic component in float 313 placed within the second cavity 12; that is, the real-time volume (V=S×ΔL+initial volume V0) is calculated by measuring the displacement (ΔL) of float 313 and combining it with the cross-sectional area of ​​the capsule (S=πr²).

[0066] Among them, the volume detection component 31 can measure the maximum volume change of the bionic ventricular capsule 20 of 795mL, which fully covers the natural ventricular stroke volume of 60mL-100mL and can simulate the ventricular volume change under various physiological conditions.

[0067] The density of float 313 is the same as the density of blood simulated in the bionic ventricular capsule 20, so that the displacement of float 313 as it rises and falls with the liquid level is linearly related to the actual volume change of the bionic ventricular capsule 20.

[0068] The pressure sensor 32 is located in the second cavity 12. The pressure sensor 32 can be a piezoresistive pressure sensor 32, which is embedded in the second cavity 12 through the side wall interface (sealed welding) to directly collect the squeezing pressure of the capsule on the second cavity 12 (i.e. the pressure value corresponding to the capsule wall tension of the bionic ventricular capsule 20).

[0069] The effective range of pressure sensor 32 is -20~40 kPa, and it can measure driving pressure from -150 mmHg to 300 mmHg.

[0070] The pressure regulating component 33 is used to regulate the pressure within the second chamber 12, causing the bionic ventricular capsule 20 to deform, compressing to simulate the contraction process of the heart and relaxing to simulate the diastolic process of the heart. The pressure regulating component 33 can be a pneumatic directional proportional valve, which has an inlet and an outlet. The inlet of the pneumatic directional proportional valve is connected to a compressed air source, and the outlet is connected to the second chamber 12 through a gas channel 121. The valve core is driven by a proportional electromagnet, which can continuously adjust the output air pressure to achieve precise control of the pressure in the second chamber 12, increasing or decreasing the pressure in the second chamber 12 to achieve the contraction and relaxation of the bionic ventricular capsule 20.

[0071] When the ventricular simulation device provided in this embodiment is working, the extracorporeal circulation loop (including a liquid medium simulating blood) fills the bionic ventricular sac 20 with liquid through the inlet 21. The sac expands and squeezes the second cavity 12. The pressure sensor 32 provides real-time feedback of the pressure value. The volume detection component 31 monitors the changes in the sac volume synchronously.

[0072] It is understood that the ventricular simulation device provided in this embodiment of the present invention reproduces the systolic-diastolic mechanism and Frank-Starling mechanism of the natural ventricle through biomechanical matching of the silicon capsule, physiological limitation of volume constraint and passive drive design of pneumatic proportional valve, providing a high-fidelity and controllable simulation tool for cardiovascular disease research, artificial organ development and medical education.

[0073] Specifically, the passive filling controlled by the pneumatic directional proportional valve is more in line with the natural ventricular mechanism. Compared with the traditional forced filling mode driven by an active piston, the ventricular simulation device provided by this invention uses the pneumatic directional proportional valve to output positive pressure (inflation) or negative pressure (exhaust) to drive the bionic ventricular capsule 20 to undergo passive deformation: when the proportional valve outputs positive pressure, compressed air enters the second chamber 12, increasing the pressure inside the second chamber 12 and squeezing the bionic ventricular capsule 20 to contract. When the pneumatic directional proportional valve switches to negative pressure, the pressure inside the second chamber 12 decreases, and the bionic ventricular capsule 20 relaxes under its own elastic restoring force, allowing liquid to flow from the circuit into the bionic ventricular capsule, simulating the diastolic filling process of the heart.

[0074] The real-time feedback from the volume detection component 31 (magnetostrictive displacement sensor) and the pressure sensor 32, combined with the high-precision adjustment of the pneumatic proportional valve, enables closed-loop control of volume, pressure, and flow. For example, in simulating heart failure (decreased ventricular compliance), the stiffness of the biomimetic ventricular capsule 20 can be increased (simulating fibrosis), while the maximum filling volume can be limited by the proportional valve. The leftward shift of the pressure-volume curve (decreased contractility) can be observed, providing a quantifiable and controllable experimental platform for studying the pathological mechanisms of heart failure.

[0075] Figure 2 This is a schematic diagram of the structure of the bionic ventricular capsule 20 in the ventricular simulation device provided in this embodiment of the present invention.

[0076] See Figure 2 In some embodiments of this invention, the stiffness of the bionic ventricular capsule 20 is configured such that, within the normal operating range, the stiffness changes slowly with volume; when contracted to the minimum volume critical value or relaxed to the maximum volume critical value, the stiffness increases rapidly with volume, limiting further changes in the volume of the bionic ventricular capsule 20. This avoids the phenomenon of the bionic ventricular capsule 20 being too large or too small, and is more in line with the working mechanism of natural ventricular contraction and relaxation.

[0077] Specifically, the bionic ventricular capsule 20 consists of a first layer (inner layer), a second layer (middle layer), and a third layer (outer layer) from the inside out.

[0078] The first layer (inner layer) is made of Ecoflex 00-10 silicone elastomer, with a Shore hardness of 00-10 and an elastic modulus of about 5-10 kPa. The inner layer is used to give the bionic ventricular capsule 20 low stiffness characteristics within the normal working range, so as to realize the easy deformation of the bionic ventricular capsule 20 during the initial contraction or relaxation process, simulating the flexibility of the human ventricle under normal physiological conditions.

[0079] The second layer (middle layer) is a composite material layer of Ecoflex 00-10 silicone elastomer and Smooth-On 25 polyurethane elastomer. The Shore hardness of the middle layer is between that of the inner and outer layers (i.e., between 00-10 and A25). The middle layer is used to construct the stiffness transition region of the bionic ventricular capsule 20 as it changes from the normal working range to the extreme state, so that the stiffness of the bionic ventricular capsule 20 increases gradually during deformation.

[0080] The third layer (outer layer) is made of Smooth-On 25 resilient polyurethane elastomer with a Shore hardness of A25 and an elastic modulus of 50-100 kPa. The outer layer is used to limit the deformation of the bionic ventricular capsule 20 when it is in extreme contraction or relaxation state, and to achieve a rapid increase in stiffness to meet the mechanical requirements of the bionic ventricular capsule 20 for extreme physiological states during the simulation process.

[0081] The bionic ventricular capsule 20 provided by this invention, through the design of the above-mentioned three-layer composite structure, can achieve gradient control of stiffness under different working conditions (normal physiological state, extreme state), thereby accurately simulating the compliance and mechanical response characteristics of the human ventricle. Through the hardness gradient and elastic modulus transition, the bionic ventricular capsule 20 has low stiffness within the normal working range to simulate physiological compliance, and under extreme deformation, the outer layer restricts deformation and achieves rapid increase in stiffness.

[0082] Continue reading Figure 1 In some embodiments of this utility model, the ventricular base 10 includes a first base 13 and a second base 14, with the second base 14 vertically disposed on the first base 13; wherein, the first cavity 11 is disposed inside the first base 13, and the second cavity 12 is disposed inside the second base 14, forming a structural basis for dual-cavity coupling.

[0083] This configuration places the first housing 13 primarily on the fluid path (accommodating the bionic ventricular capsule 20 and facilitating the circulation of simulated blood), while the second housing 14 focuses on the pneumatic path (achieving pneumatic pressure control through the second chamber 12 in conjunction with the pressure regulating component 33). The vertical layout completely separates the fluid path (first chamber 11) and the pneumatic path (second chamber 12) spatially, avoiding the problems of liquid leakage contaminating the pneumatic path or pressure fluctuations interfering with fluid path stability inherent in traditional co-chamber designs. For example, the inlet 21 / outlet 22 (fluid path interface) of the bionic ventricular capsule 20 is located in the first housing 13, while the gas channel 121 (pneumatic path interface) is located in the second housing 14. The vertical structure naturally separates them, reducing the risk of cross-interference and improving system reliability.

[0084] Furthermore, the second chamber 12 (the pneumatic pressure application space) is connected to the external pressure regulating component 33 (such as a pneumatic directional proportional valve) of the second seat 14 via a microchannel or through-hole, while the first chamber 11 is connected to the extracorporeal circulation loop through a side wall opening. The vertical layout brings the second chamber 12 closer to the ventricular capsule (the second seat 14 is located above the first seat 13, and the second chamber 12 is coupled to the bionic ventricular capsule 20), shortening the pressure transmission path (the distance from the gas channel 121 to the ventricular capsule is shorter), reducing the attenuation and delay of pressure fluctuations, and more realistically simulating the rapidity of cardiac contraction.

[0085] Continue reading Figure 1 The ventricular simulation device provided by this utility model, when performing a mode:

[0086] First, the pneumatic directional proportional valve outputs positive pressure, filling the second chamber 12 with compressed gas, which increases the pressure inside the second chamber 12, causing the bionic ventricular capsule 20 to contract and the liquid to be discharged from the bionic ventricular capsule 20 into the circulation loop, simulating the contraction and ejection process of the heart.

[0087] When the bionic ventricular capsule 20 contracts to a certain extent, its stiffness increases rapidly and it can no longer contract. At this time, the bionic ventricular capsule 20 enters the diastolic phase. The pneumatic directional proportional valve outputs negative pressure to reduce the pressure in the second chamber 12, causing the bionic ventricular capsule 20 to relax under its own elasticity and the pressure of the circuit fluid. This allows the fluid to flow from the circuit into the bionic ventricular capsule 20, simulating the diastolic filling process of the heart.

[0088] It should be noted that, to ensure unidirectional liquid flow, a four-valve silicone check valve is installed at the inlet 21 (left side) of the bionic ventricular capsule 20. The silicone is soft and elastic, capable of fulfilling the check valve function while absorbing a certain amount of pressure shock. When the inlet pressure of the check valve is greater than the outlet pressure, the check valve opens; when the pressure at the outlet 22 is greater than or equal to the pressure at the inlet 21, the check valve will quickly close due to the pressure at the outlet 22 and the elasticity of the silicone itself.

[0089] When the bionic ventricular capsule 20 relaxes to a certain extent, it can no longer relax. At this time, according to the Frank-Starling mechanism, the ventricular volume increases at the end of diastole, the myocardial contractility coefficient increases, the ventricle enters the systolic phase, and the pneumatic proportional valve outputs positive pressure to compress the bionic ventricular capsule 20 to contract.

[0090] This invention also provides an in vitro biomimetic cardiopulmonary circulation simulation system, which includes a control module, a gas exchange module, circulation tubing, and a ventricular simulation device (as described above). The ventricular simulation device is used to simulate the contraction and relaxation of the heart, driving the flow of simulated blood fluid in the circulation tubing.

[0091] The gas exchange module simulates the exchange of oxygen and carbon dioxide in the lungs, maintaining the oxygenation and acid-base balance of the simulated blood solution. The gas exchange module may include a gas mixing module, an oxygenator (artificial lung), etc.

[0092] The gas mixing module precisely adjusts the gas mixing ratio via a mass flow controller before inputting it into the oxygenator. The oxygenator (artificial lung) uses a hollow fiber membrane or microchannel structure to simulate the gas exchange process between the alveoli and capillaries.

[0093] The circulation tubing is connected to the ventricular simulation device and the gas exchange module to simulate blood flow. The circulation tubing can be made of flexible tubing (such as PVC or silicone) with an inner diameter that matches that of human blood vessels (e.g., the inner diameter of the aorta is about 20-30 mm, and the inner diameter of the capillaries is about 5-10 μm). In some scenarios, a resistance regulating valve (simulating vascular resistance, such as peripheral resistance) or a shunt valve (simulating collateral circulation) needs to be integrated.

[0094] The control module is electrically connected to both the ventricular simulation device and the gas exchange module. The control module includes a controller, a sensor array, and a software platform.

[0095] The controller can be a PLC (Programmable Logic Controller) or a high-performance industrial computer, integrating a motion control card (to drive the proportional valve), a data acquisition card (to read sensor signals), and a communication interface (such as CAN bus or Modbus).

[0096] The sensor array can include flow sensors (such as electromagnetic flow meters and ultrasonic Doppler flow meters), temperature sensors (PT100 resistance temperature detectors), blood oxygen sensors (based on photoplethysmography), etc., covering key parameters of the circulatory system.

[0097] The software platform may include a human-computer interface (HMI): The HMI displays real-time data (such as cardiac output, blood oxygen, and blood pressure curves) via a touch screen or PC software, and supports parameter settings (such as target heart rate and tidal volume) and mode selection (normal / heart failure / pulmonary embolism).

[0098] This invention provides an in vitro biomimetic cardiopulmonary circulation simulation system that can simulate the coordinated working process of the human cardiovascular and respiratory systems, providing a high-fidelity experimental environment for cardiovascular disease research, artificial organ (such as artificial hearts and ventricular assist devices) research and development testing, drug efficacy evaluation, and medical education. Its core function is to reproduce physiological processes such as hemodynamics, gas exchange, and acid-base balance through multi-module collaboration, and to support dynamic simulation of pathological states (such as heart failure and pulmonary embolism).

[0099] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and not to limit it. Although this utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this utility model.

Claims

1. A ventricular simulation device, characterized in that, include: The ventricular base has an internal structure with a first cavity and a second cavity that are interconnected. The first cavity has a first opening and a second opening, and the second cavity has a gas passage. A biomimetic ventricular capsule is disposed in the first cavity. The biomimetic ventricular capsule has an inlet and an outlet. The inlet and the outlet are respectively connected to the extracorporeal circulation loop to simulate the ventricle. The inlet is connected to the first opening, and the outlet is connected to the second opening. The detection and adjustment components include: A volume detection component is disposed on the ventricular base and is used to detect the volume of the bionic ventricular capsule based on displacement changes; A pressure sensor is disposed in the second cavity, and the pressure sensor is used to collect the pressure value corresponding to the wall tension of the bionic ventricular capsule; A pressure regulating component, connected to the gas channel, is used to regulate the pressure within the second cavity to cause the bionic ventricular capsule to deform, thereby simulating the contraction and relaxation process of the heart.

2. The ventricular simulation device according to claim 1, characterized in that, The stiffness of the biomimetic ventricular capsule is configured as follows: Within the normal operating range, the stiffness of the bionic ventricular capsule changes slowly with volume; When the bionic ventricular capsule contracts to the minimum volume critical value or relaxes to the maximum volume critical value, the stiffness of the bionic ventricular capsule increases rapidly with the volume, limiting the further change in the volume of the bionic ventricular capsule.

3. The ventricular simulation device according to claim 2, characterized in that, The biomimetic ventricular capsule comprises, from the inside out, a first layer, a second layer, and a third layer; The first layer has a Shore hardness of 00-10 and an elastic modulus of 5-10 kPa; The third layer has a Shore hardness of A25 and an elastic modulus of 50-100 kPa. The Shore hardness of the second layer is between that of the first layer and the third layer.

4. The ventricular simulation device of claim 1, wherein, The volume detection component includes a magnetostrictive displacement sensor, the effective stroke of which is 0 mm to 125 mm.

5. The ventricular analog device of claim 4, wherein, The magnetostrictive displacement sensor includes: The detection body is located on top of the ventricular base; The waveguide wire is fixed along the axial direction of the second cavity; A float is disposed on the waveguide wire and embedded at the top center of the bionic ventricular capsule, for axial movement along the waveguide wire as the liquid level changes; the float is provided with a magnetic component.

6. The ventricular analog of claim 5, wherein, The density of the float is the same as the density of the simulated blood inside the bionic ventricular capsule, so that the displacement of the float as it rises and falls with the liquid level is linearly related to the actual volume change of the bionic ventricular capsule.

7. The ventricular simulation device of claim 1, wherein, The pressure sensor has a measurement range of -150 mmHg to 300 mmHg.

8. The ventricular simulation device of claim 1, wherein, The pressure regulating component includes a pneumatic directional proportional valve; The pneumatic directional proportional valve has an air inlet and an air outlet. The air inlet is adapted to be connected to a compressed air source, and the air outlet is connected to the gas channel. The pneumatic directional proportional valve is used to adjust the pressure in the second cavity so that the bionic ventricular capsule can perform contraction and relaxation.

9. The ventricular analogue device according to any one of claims 1 to 8, characterized in that The ventricular base includes: The first body; The second seat is vertically mounted on the first seat; The first cavity is located inside the first seat, and the second cavity is located inside the second seat.

10. An in vitro biomimetic cardiopulmonary circulation simulation system, characterized in that, Includes the ventricular simulation device according to any one of claims 1 to 9.

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