Ventricular simulation device and extracorporeal circulation simulation system

Through the structure of the first simulation chamber and the second simulation chamber of the ventricular simulation device, combined with the air pump to control the flow of the medium, the problem of simulating the human heart failure state in the prior art is solved, and the hemodynamic characteristics and stability test of the catheter pump in complex scenarios is realized, which simplifies the motor driving method and reduces costs.

CN223284689UActive Publication Date: 2025-08-29SHANGHAI PHIGINE MEDICAL CO LTD
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Patent Information

Application Number
CN202422172289.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-09-04
Publication Date
2025-08-29
Estimated Expiration
2034-09-04

AI Technical Summary

Technical Problem

The prior art is difficult to accurately simulate various heart failure states of the human body, and the reciprocating mode of the motor drive piston has high requirements for motor performance and control algorithms, which makes it difficult to simulate the blood pressure waveform of the human body.

Method used

Using the first simulation chamber and the second simulation chamber structure, the second simulation chamber is driven to contract and dilation by changing the media pressure in the medium cavity, simulating the pulsation function of the heart, and controlling the flow of the medium with the air pump, simplifying the motor driving method.

Benefits of technology

The hemodynamic characteristics and operating stability test of the catheter pump in complex clinical scenarios is achieved. It has a simple structure, low cost, easy to operate, and accurate simulation effect.

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Abstract

The utility model discloses a ventricular simulation device and an extracorporeal circulation simulation system, the ventricular simulation device comprises a first simulation chamber and a second simulation chamber arranged in the first simulation chamber, and a first medium cavity is formed between the first simulation chamber and the second simulation chamber. The first simulation chamber is provided with a medium circulation opening communicated with the first medium cavity so as to change the medium pressure in the first medium cavity. A second medium cavity is formed in the second simulation chamber, and when the medium pressure in the first medium cavity is larger than the sum of the medium pressure in the second medium cavity and the minimum pressure needed by deformation of the second simulation chamber, the second simulation chamber shrinks and discharges the medium; and when the sum of the medium pressure in the first medium cavity and the minimum pressure required for deformation of the second simulation chamber is smaller than the medium pressure in the second medium cavity, the second simulation chamber expands, and the medium enters the second medium cavity. The contraction and relaxation of the second simulation chamber are realized by changing the compression state of the second simulation chamber, so that the contraction and relaxation of the left ventricle are accurately simulated, various heart failure states of a human body are accurately simulated, and the test is convenient.
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Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a ventricular simulation device and an extracorporeal circulation simulation system. Background Art

[0002] Heart failure is a serious cardiovascular disease, and its incidence is increasing with the aging population. Besides end-stage heart failure, heart failure can also occur as a complication or acute symptom. For example, patients with high-risk coronary artery disease who require percutaneous coronary intervention (PCI) often experience acute heart failure. Symptoms such as myocardial ischemia or arrhythmias may occur during treatment, posing a risk of hemodynamic compromise. Therefore, cardiac assist is required to maintain left ventricular function during treatment. Cardiogenic shock is an extreme manifestation of heart failure. Severe heart failure can cause acute peripheral circulatory failure. This sudden onset of illness urgently requires a rapid assist device to restore ventricular function and potentially save lives. Unlike traditional left ventricular assist devices (LVADs), which have long lifespans and low replacement rates, invasive ventricular assist devices (PVADs) offer a shorter treatment time, are convenient and efficient to implant, and are minimally invasive. They also reduce the complexity and time required by physicians during PCI procedures, significantly lowering the surgical risk for heart failure patients. Therefore, interventional treatment for heart failure has been hailed as the next wave in cardiovascular intervention.

[0003] Interventional catheter pumps are Class III medical devices, placing high performance demands on them in clinical applications. They require not only excellent hemodynamic properties but also good stability when assisting with heart failure. Therefore, prior to formal clinical trials, it is necessary to utilize in vitro simulation devices to realistically reflect the complex physiological states of heart failure patients and to investigate the hemodynamic properties and operational stability of catheter pumps in complex clinical scenarios. Furthermore, most in vitro circulatory simulation systems currently used by domestic and international research institutions and on the market utilize a motor-driven piston reciprocating motion to simulate the heart's contraction and relaxation processes. This drive method places high demands on motor performance and control algorithms, making it challenging to accurately simulate human blood pressure waveforms.

[0004] Therefore, how to improve the technical defects in the existing technology and develop a ventricular simulation device that can accurately simulate various heart failure states of the human body has always been an urgent problem to be solved by ordinary technicians in this field. Utility Model Content

[0005] The purpose of this application is to provide a ventricular simulation device and an extracorporeal circulation simulation system with a simple structure that can accurately simulate various heart failure states of the human body, which is conducive to testing and studying the hemodynamic characteristics and operating stability of catheter pumps in complex clinical scenarios.

[0006] The technical solutions provided in this application are as follows:

[0007] A ventricular simulation device, comprising:

[0008] a first simulation chamber and a second simulation chamber at least partially disposed within the first simulation chamber;

[0009] The first simulation chamber and the second simulation chamber are isolated from each other, and a first medium cavity is formed between the first simulation chamber and the second simulation chamber. The first simulation chamber is provided with a medium flow port connected to the first medium cavity to change the medium pressure in the first medium cavity;

[0010] A second medium cavity is formed in the second simulation chamber, and the second simulation chamber is provided with a medium inlet and a medium outlet. When the medium pressure in the first medium cavity is greater than the sum of the medium pressure in the second medium cavity and the minimum pressure required for deformation of the second simulation chamber, the second simulation chamber is compressed and contracts, and the medium in the second medium cavity is discharged through the medium outlet. When the sum of the medium pressure in the first medium cavity and the minimum pressure required for deformation of the second simulation chamber is less than the medium pressure in the second medium cavity, the second simulation chamber expands, and the medium enters the second medium cavity through the medium inlet.

[0011] In some embodiments, the ventricular simulation device further comprises:

[0012] a first mounting frame;

[0013] The second simulation chamber is mounted on the first mounting frame. The first simulation chamber is provided with an opening suitable for allowing the second simulation chamber to extend into the interior of the first simulation chamber, wherein the first mounting frame at least covers and blocks the gap between the edge of the opening of the first simulation chamber and the outer wall of the second simulation chamber.

[0014] In some embodiments, a limit platform is provided on the inner wall of the first simulation chamber, and a limit opening is provided on the limit platform for the second simulation chamber to pass through, so as to limit the position of the second simulation chamber within the first simulation chamber.

[0015] In some embodiments, the number of the medium flow openings is two, symmetrically arranged on opposite sides of the second simulation chamber; and,

[0016] The medium inlet and the medium outlet are both arranged on a side of the second simulation device facing the first mounting bracket, and the first mounting bracket is provided with a first joint communicating with the medium inlet and a second joint communicating with the medium outlet.

[0017] In some embodiments, the medium inlet and the medium outlet are the same opening, and the opening is provided on a side of the second simulation device facing the first mounting bracket, for connecting the first connector and the second connector.

[0018] In some embodiments, the ventricular simulation device further comprises:

[0019] The second mounting frame is located on a side of the first simulation chamber away from the first mounting frame. The first mounting frame and the second mounting frame jointly clamp the first simulation chamber to fix the first simulation chamber and the second simulation chamber.

[0020] In some embodiments, a plurality of fastening holes are provided on the first mounting bracket and the second mounting bracket, and fasteners pass through the fastening holes on the first mounting bracket and the fastening holes on the second mounting bracket in sequence to securely connect the first mounting bracket and the second mounting bracket.

[0021] In some embodiments, the first mounting frame includes a first fixing plate and a first docking plate arranged at an angle, the first fixing plate is used to mount the second simulation chamber, and the first docking plate is used to dock with an external structure; and / or,

[0022] The first mounting frame includes a second fixing plate and a second docking plate arranged at an angle, the second fixing plate and the first fixing plate jointly clamp the first simulation chamber, and the second docking plate is used for docking with an external structure.

[0023] In some embodiments, the medium in the first medium cavity is gas, and the medium flow port is externally connected to an air pump; the medium in the second medium cavity is liquid.

[0024] The present application also provides an extracorporeal circulation simulation system, comprising:

[0025] An air pump, an atrioventricular valve simulation device, an aortic valve simulation device, and a ventricular simulation device provided in any of the above embodiments, wherein the medium flow port is externally connected to the air pump, the air pump is used to control the air pressure in the first medium cavity, the medium inlet is connected to the atrioventricular valve simulation device, and the medium outlet is connected to the aortic valve simulation device.

[0026] The technical effects of this application are:

[0027] 1. In this application, the ventricular simulation device includes a first simulation chamber and a second simulation chamber, wherein the second simulation chamber is used to simulate the left ventricle, and the first simulation chamber is arranged outside the second simulation chamber. By changing the medium pressure between the first simulation chamber and the second simulation chamber (in the first medium chamber), the state of the second simulation chamber can be changed. For example, when the medium pressure increases, the second simulation chamber contracts, and when the medium pressure decreases, the second simulation chamber relaxes. In this way, the contraction and relaxation of the left ventricle can be accurately simulated, thereby driving the circulation of the medium in the second simulation chamber, creating a pulsating environment that simulates the physical state of a heart failure patient, and facilitating the testing and research of the hemodynamic characteristics and operational stability of the catheter pump in complex clinical scenarios.

[0028] 2. In this application, the first mounting frame and the second mounting frame can jointly clamp the first simulation chamber to secure it. Simultaneously, the second simulation chamber can be secured within the first simulation chamber via the first mounting frame. The first mounting frame can also block the gap between the opening edge of the first simulation chamber and the outer wall of the second simulation chamber, preventing leakage of the medium within the first medium cavity. This ensures the airtightness of the first simulation chamber, improves the simulation effect, and facilitates the long-term stable operation of the ventricular simulation device.

[0029] 3. In the present application, a limit platform is also provided in the first simulation chamber, and a limit opening is provided on the limit platform for the second simulation chamber to pass through, which can limit the position of the second simulation chamber relative to the first simulation chamber, so that the second simulation chamber is not prone to position deviation during the contraction and relaxation process and has good stability.

[0030] 4. In the present application, the medium flow port allows the medium to enter and exit the first medium cavity. By providing two symmetrically distributed medium flow ports, the second simulation chamber can be subjected to uniform force, which is also conducive to the rapid response of the second simulation chamber. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] The present application is further described in detail below with reference to the accompanying drawings and specific embodiments:

[0032] Figure 1 This is a perspective view of the three-dimensional structure of a ventricular simulation device provided in one embodiment of the present application;

[0033] Figure 2 This is a schematic structural diagram of an extracorporeal circulation simulation system provided in one embodiment of the present application;

[0034] Figure 3 This is a cross-sectional view of an aortic valve clamping device provided in one embodiment of the present application.

[0035] Description of Figure Numbers:

[0036] 100, ventricular simulation device; 110, first simulation chamber; 111, position limiting platform; 120, second simulation chamber; 121, second medium cavity; 122, opening; 130, first medium cavity; 140, medium flow port; 150, first mounting frame; 151, first fixing plate; 1511, first joint; 1512, second joint; 152, first docking plate; 160, second mounting frame; 161, second fixing plate; 162, second docking plate;

[0037] 201. Air pump control unit; 202. Trachea; 203. Flow control valve; 204. Atrioventricular valve simulator; 205. Arterial valve simulator; 206. Connecting pipe; 207. Catheter pump; 2071. Fluid inflow window; 2072. Fluid outflow window; 208. First pressure sensor; 209. Second pressure sensor; 210. Damping valve; 211. Compliance chamber; 212. Venous cavity; 213. Left atrium simulator; 214. Flowmeter.

[0038] 300, aortic valve clamping device; 310, inlet flange; 311, first cavity; 312, fluid inlet; 320, outlet flange; 321, second cavity; 322, side conduit; 323, fluid outlet;

[0039] 401. Stud; 402. Butterfly nut. DETAILED DESCRIPTION

[0040] In the following description, specific details such as specific system structures and technologies are provided for illustration rather than limitation to facilitate a thorough understanding of the embodiments of the present application. However, it should be clear to those skilled in the art that the present application may be implemented in other embodiments without these specific details. In other cases, detailed descriptions of well-known systems, devices, circuits, and methods are omitted to avoid obstructing the description of the present application with unnecessary details.

[0041] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the specific implementation methods of the present application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are only some embodiments of the present application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without inventive work.

[0042] To simplify the drawings, only the parts relevant to the utility model are schematically shown in each figure; they do not represent the actual structure of the product. Furthermore, to simplify the drawings and facilitate understanding, in some figures, only one of the components with the same structure or function is schematically depicted or labeled. In this document, "one" not only means "only one" but also "more than one."

[0043] It should be further understood that the term "and / or" used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

[0044] It should be noted that, unless otherwise specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. For example, they can refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0045] In the embodiments shown in the accompanying drawings, directional indications (such as up, down, left, right, front, and back) are used to explain the structure and movement of various components of the present application, not absolute but relative. These descriptions are applicable when these components are in the positions shown in the accompanying drawings. If the descriptions of the positions of these components are changed, these directional indications will also change accordingly.

[0046] In addition, in the description of the present application, the terms "first", "second", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance.

[0047] As an interventional ventricular assist device, a catheter pump, after being implanted in the human body, works together with the heart of a heart failure patient to maintain normal blood circulation. The catheter pump not only needs to have excellent hemodynamic characteristics when assisting, but also needs to have good stability. Therefore, it is necessary to use an in vitro simulation device to truly reflect the various complex physiological states of heart failure patients before formal clinical trials, and to explore the hemodynamic characteristics and operational stability of the catheter pump in complex clinical scenarios. At present, most of the in vitro simulation circulation systems on the market and domestic and foreign research institutions use motor-driven piston reciprocating motion to simulate the contraction and relaxation process of the heart. This driving method has high requirements on motor performance and control algorithms, and has certain difficulties in accurately simulating the human blood pressure waveform.

[0048] In response to the above problems, this application proposes a ventricular simulation device for testing the hemodynamic performance of an interventional catheter pump, which can accurately simulate various heart failure states of the human body. The ventricular simulation device has a simple structure, low cost and is easy to operate.

[0049] For example, see Figure 1 and Figure 2A ventricular simulation device 100 includes a first simulation chamber 110 and a second simulation chamber 120 at least partially disposed within the first simulation chamber 110. The first and second simulation chambers 110, 120 are independent and isolated from each other, so that the ventricular simulation device 100 forms a highly airtight first medium cavity 130 between the first and second simulation chambers 110, 120. The first simulation chamber 110 defines a medium flow port 140 connected to the first medium cavity 130, allowing medium to enter and exit the first medium cavity 130 through the medium flow port 140, thereby varying the medium pressure within the first medium cavity 130. The second simulation chamber 120 is preferably made of elastic silicone and defines a second medium cavity 121 within the second simulation chamber 120. The second simulation chamber 120 defines a medium inlet and a medium outlet. By varying the medium pressure within the first medium cavity 130, the stress state of the second simulation chamber 120 can be varied, allowing the medium within the first medium cavity 130 to enter or exit the second medium cavity 121 through the medium inlet or exit through the medium outlet. For example, when the medium pressure in the first medium cavity 130 is greater than the medium pressure in the second medium cavity 121, and the difference in medium pressure between the two is greater than the minimum pressure required for the second simulation chamber 120 to deform (i.e., the medium pressure in the first medium cavity 130 is greater than the sum of the medium pressure in the second medium cavity 121 and the minimum pressure required for the second simulation chamber 120 to deform), the second simulation chamber 120 can be driven to deform, and the second simulation chamber 120 is compressed and contracted, and the medium in the second medium cavity 121 is discharged through the medium outlet. Conversely, when the medium pressure in the first medium cavity 130 is less than the medium pressure in the second medium cavity 121, and the difference in medium pressure between the two is greater than the minimum pressure required for the second simulation chamber 120 to deform (i.e., the sum of the medium pressure in the first medium cavity 130 and the minimum pressure required for the second simulation chamber 120 to deform is less than the medium pressure in the second medium cavity 121), the second simulation chamber 120 can be driven to deform, and the second simulation chamber 120 expands, and the medium enters the second medium cavity 121 through the medium inlet.

[0050] This embodiment employs a first simulation chamber 110 disposed outside a second simulation chamber 120. Filling or pumping medium into a first medium cavity 130 formed between the first and second simulation chambers 110 enables the contraction and expansion of the second simulation chamber 120, thereby simulating the beating function of the human heart. The device features a simple structure and is easy to operate. Compared to conventional methods that use a motor to drive a piston to reciprocate to simulate the contraction and expansion of the heart, the ventricular simulator 100 provided in this embodiment has lower requirements for motor performance and control algorithms, making it easier to accurately simulate the pressure waveform of human blood.

[0051] Specifically, taking air as the medium in the first medium cavity 130 as an example, the medium flow port 140 is connected to an external air pump through the trachea 202, and the air pump is electrically connected to a controller, so that the controller drives the air pump to periodically deliver and recover gas according to preset conditions (setting parameters such as pumping volume and pumping value according to the heart failure state to be simulated), thereby realizing the periodic contraction and relaxation of the second simulation chamber 120, thereby accurately simulating the beating function of the human heart in different states, driving the circulation of the medium in the second simulation chamber 120, and building a pulsating environment simulating the physical state of a heart failure patient, so as to test and study the hemodynamic characteristics and operating stability of the catheter pump 207 in complex clinical scenarios.

[0052] In practical applications, the ventricular simulator 100 provided in this embodiment is primarily used to simulate the left ventricle. The medium inlet on the second simulation chamber 120 is used to connect to an external mitral valve simulator, and the medium outlet is used to connect to an external aortic valve simulator. Of course, the ventricular simulator 100 can also be used to simulate the right ventricle. In this case, the medium inlet on the second simulation chamber 120 is used to connect to an external tricuspid valve simulator, and the medium outlet is used to connect to an external pulmonary valve simulator. This is not a limitation and is within the scope of protection of this application.

[0053] Preferably, in order to more accurately simulate the beating function of the human heart and build a pulsating environment that simulates the physical state of a heart failure patient, the medium in the second medium cavity 121 is preferably fluid, so as to better simulate the blood flow in the human body.

[0054] Specifically, see Figure 1 The first simulation chamber 110 has an opening suitable for extending the second simulation chamber 120 into the interior of the first simulation chamber 110. This opening should also be provided with a sealing member or a component capable of sealing the gap between the edge of the opening and the outer wall of the second simulation chamber 120 to ensure the airtightness of the first medium cavity 130 and prevent leakage during operation of the ventricular simulator 100, which could affect the simulation effect of the second simulation chamber 120. Furthermore, to prevent significant positional displacement of the second simulation chamber 120 during contraction and relaxation, a structure capable of restraining the second simulation chamber 120 should be provided within the first simulation chamber 110.

[0055] To achieve lightweight production and high integration, in a preferred embodiment, the ventricular simulator 100 further includes a first mounting frame 150, upon which the second simulation chamber 120 can be mounted. The first mounting frame 150 at least covers and seals the gap between the opening edge of the first simulation chamber 110 and the outer wall of the second simulation chamber 120. This effectively limits the displacement of the second simulation chamber 120 while ensuring the airtightness of the first dielectric cavity 130, resulting in a more rational and simple structural arrangement.

[0056] Furthermore, a limit platform 111 is provided on the inner wall of the first simulation chamber 110, and a limit opening is opened on the limit platform 111 for the second simulation chamber 120 to pass through, which can limit the position of the second simulation chamber 120 relative to the first simulation chamber 110 away from the side of the first mounting frame 150, so that the second simulation chamber 120 is less likely to deviate from its position during the contraction and relaxation process, has good stability and better simulation effect.

[0057] Among them, the number of medium flow openings 140 on the first simulation chamber 110 is preferably two, which are symmetrically arranged on opposite sides of the second simulation chamber 120, and the medium inlet and the medium outlet are both arranged on the side of the second simulation device facing the first mounting bracket 150. The first mounting bracket 150 is provided with a first joint 1511 connecting to the medium inlet and a second joint 1512 connecting to the medium outlet.

[0058] This embodiment provides two symmetrically distributed medium flow ports 140, which facilitates uniform force distribution in the second simulation chamber 120, resulting in better and more stable pumping performance and a longer service life. Furthermore, the two medium flow ports 140 also facilitate rapid response in the second simulation chamber 120. Furthermore, the present application also provides a medium inlet and outlet on the side of the second simulation chamber 120 facing the first mounting bracket 150, connecting to a first connector 1511 and a second connector 1512, respectively. This model better conforms to the actual human ventricle and facilitates a realistic reflection of the various complex physiological states of heart failure patients.

[0059] For example, see Figure 1 The medium inlet and outlet of second simulation chamber 120 can also be integrated into a single opening 122, located on the side of second simulation chamber 120 facing first mounting frame 150, and connecting first joint 1511 and second joint 1512. In other words, second simulation chamber 120 has a bowl-shaped structure, which is fixed upside down on first mounting frame 150, resulting in a simpler structure and lower material costs.

[0060] In one embodiment, see Figure 1 and Figure 2 The ventricular simulation device 100 further includes a second mounting frame 160, which is located on the side of the first simulation chamber 110 away from the first mounting frame 150, and clamps the first simulation chamber 110 together with the first mounting frame 150 to fix the first simulation chamber 110 and the second simulation chamber 120, which is more conducive to integrating the ventricular simulation device 100 into the extracorporeal circulation system and realizing long-term stable operation of the ventricular simulation device 100.

[0061] Specifically, a plurality of fastening holes are provided on the first mounting frame 150 and the second mounting frame 160 , and fasteners pass through the fastening holes on the first mounting frame 150 and the fastening holes on the second mounting frame 160 in sequence to fix the first mounting frame 150 and the second mounting frame 160 together.

[0062] Among them, see Figure 1 The fasteners are preferably studs 401. After the studs 401 are passed through the fastening holes on the first mounting frame 150 and the second mounting frame 160, the butterfly nuts 402 are tightened on both ends of the studs 401, so that the first mounting frame 150 and the second mounting frame 160 are pressed against the two ends of the first simulation chamber 110, thereby achieving stable fixation of the first simulation chamber 110 and the second simulation chamber 120. The operation is convenient and the connection reliability is high, which is conducive to the long-term stable operation of the ventricular simulation device 100.

[0063] In this embodiment, the first simulation chamber 110 and the second simulation chamber 120 are fixed by clamping at both ends. Compared with providing docking structures at both ends of the first simulation chamber 110 that can be connected to the first mounting frame 150 and the second mounting frame 160, the overall structural setting is significantly simpler, and the number of parts required for installation is also fewer. The installation steps are simple and convenient, and it is also more in line with lightweight production requirements and low cost.

[0064] Specifically, the first mounting frame 150 includes a first fixing plate 151 and a first docking plate 152, which are arranged at an angle. The first fixing plate 151 is used to mount the second simulation chamber 120, and the first docking plate 152 is used to dock with an external structure. Conversely, the second mounting frame 160 may also include a second fixing plate 161 and a second docking plate 162, which are arranged at an angle. The second fixing plate 161 and the first fixing plate 151 jointly clamp the first simulation chamber 110, and the second docking plate 162 is used to dock with an external structure. By providing the first docking plate 152 and the second docking plate 162 capable of docking with an external structure, this embodiment facilitates the user in securing the ventricular simulation device 100 in a desired position, thereby achieving stable operation of the ventricular simulation device 100.

[0065] See also Figure 2 The present application also provides an extracorporeal circulation simulation system, comprising an air pump, an atrioventricular valve simulation device 204, an aortic valve simulation device 205, and the ventricular simulation device 100 provided in any of the above embodiments. The medium flow port 140 is externally connected to the air pump, which is used to control the air pressure in the first medium chamber 130. The medium inlet is connected to the atrioventricular valve simulation device 204, and the medium outlet is connected to the aortic valve simulation device 205.

[0066] Specifically, the air pump and the ventricular simulation device 100 are connected via an air tube 202, and the atrioventricular valve simulation device 204, the aortic valve simulation device 205, and the ventricular simulation device 100 are all connected via a connecting tube 206. The connecting tube 206 is used to simulate an artery and can simulate the shape and elasticity of the human arterial tube. For example, when the ventricular simulation device 100 is used to simulate the left ventricle, the atrioventricular valve simulation device 204 is used to simulate the mitral valve, the aortic valve simulation device 205 is used to simulate the aortic valve, and the connecting tube 206 simulates the aorta. In this case, the extracorporeal simulated circulatory system can be used to simulate the assistance of the left ventricle catheter pump 207. If the ventricular simulation device 100 is used to simulate the right ventricle, the atrioventricular valve simulation device 204 is used to simulate the tricuspid valve, the aortic valve simulation device 205 is used to simulate the pulmonary valve, and the connecting tube 206 simulates the pulmonary artery. In this case, the extracorporeal simulated circulatory system is used to simulate the assistance of the right ventricle catheter pump 207.

[0067] Specifically, using the example of simulating left ventricular catheter pump 207 assistance, the extracorporeal circulatory system can also include a catheter pump 207 and a controller. The catheter pump 207 extends into the aortic valve and works with the ventricular simulator 100 to maintain the circulation of the medium within the second medium chamber 121. The controller is used to control the operating state of the air pump, thereby adjusting the operating state of the ventricular simulator 100, allowing testers to test and study the hemodynamic characteristics and operational stability of the catheter pump 207 in complex clinical scenarios.

[0068] Among them, the air pump and the controller can be integrated into an air pump control unit 201, and a flow regulating valve 203 is also provided on the air pipe 202 to adjust the gas flow output by the air pump, thereby controlling the force of the medium in the first medium cavity 130 acting on the second simulation chamber 120, thereby achieving the ability to adjust the contraction and relaxation strength of the left ventricle.

[0069] Furthermore, a first pressure sensor 208 and a second pressure sensor 209 are installed on the connecting tube 206, respectively, in front and behind the corresponding aortic valve simulator 205, capable of measuring left ventricular pressure and aortic pressure. The extracorporeal simulated circulatory system also includes a data acquisition system for receiving and displaying data from the first and second pressure sensors 208 and 209. Furthermore, the extracorporeal simulated circulatory system further includes an extracorporeal control device for driving the catheter pump 207.

[0070] Furthermore, connecting line 206 is equipped with a damping valve 210, a compliance chamber 211, a venous cavity 212, and a left atrial simulator 213. A flowmeter 214 is provided between compliance chamber 211 and venous cavity 212 to measure aortic flow. Damping valve 210 regulates aortic flow. Fluid flowing out of venous cavity 212 flows back into ventricular simulator 100 via damping valve 210, left atrial simulator 213, and atrioventricular valve simulator 204.

[0071] In a preferred embodiment, see Figure 3 The extracorporeal simulated circulation system may further include an arterial valve clamping device 300, in which the arterial valve simulation device 205 and the catheter pump 207 are both installed. The arterial valve clamping device 300 includes an inlet flange 310 and an outlet flange 320. A first cavity 311 having a first opening is formed in the inlet flange 310. The first cavity 311 is suitable for accommodating the arterial valve simulation device 205, and a fluid inlet 312 is provided at one end of the first cavity 311 away from the first opening. Conversely, a second cavity 321 having a second opening is formed in the outlet flange 320, and a fluid outlet 323 is provided at one end of the second cavity 321 away from the second opening. The side of the inlet flange 310 with the first opening and the side of the outlet flange 320 with the second opening can be mated with each other to connect the first cavity 311 and the second cavity 321. In addition, a side pipe 322 is provided on the outlet flange 320, one end of which is connected to the first cavity 311, and the other end extends through the side wall of the second cavity 321 to the outside of the outlet flange 320. In this way, part of the fluid entering the outlet flange 320 through the inlet flange 310 will flow out through the side pipe 322, and the remaining part will flow out through the fluid outlet 323 on the outlet flange 320.

[0072] In this embodiment, the side conduit 322 is used to house the catheter pump 207. The distal end of the catheter pump 207 (the end away from the operator) is inserted into the aortic valve clamping device 300 through the side conduit 322 until the fluid inlet window 2071 on the catheter pump 207 is located within the first cavity 311 on the inlet flange 310. At this point, the fluid outlet window 2072 on the catheter pump 207 is located exactly within the side conduit 322, allowing the fluid pumped by the catheter pump 207 to flow completely into the side conduit 322 after exiting the fluid outlet window 2072. In this way, by measuring the flow rate in the side conduit 322, the pumping flow rate of the catheter pump 207 can be obtained, which facilitates testers to test and study the hemodynamic characteristics and operational stability of the catheter pump 207 in complex clinical scenarios.

[0073] Specifically, when the extracorporeal simulated circulatory system provided in this embodiment is actually used, the catheter pump 207 should first be placed in the aortic valve clamping device 300, the air pump control unit 201 should be turned on to set the desired left ventricular pressure value and heart rate, the data from the first pressure sensor 208, the second pressure sensor 209, and the flow meter 214 should be read, the flow control valve 203 should be adjusted to near the target value, and then the height of the compliance chamber 211 and the damping valve 210 should be adjusted to ensure that the left ventricular pressure, aortic pressure, and aortic flow meet the expected physiological characteristics of a heart failure patient. The catheter pump 207 should be started and maintained at a specific gear by the extracorporeal control device. After its speed stabilizes, the system's left ventricular pressure, aortic pressure, aortic flow, and the flow rate of the catheter pump 207 should be read.

[0074] In addition to accurately simulating different heart failure states in the human body, this extracorporeal circulation simulation device can also measure the extreme assistance effect of catheter pump 207 and the stability of flow and pressure during long-term operation, facilitating the evaluation of the actual performance of catheter pump 207. Furthermore, the system has a simple structure, low cost, and is easy to operate and maintain.

[0075] In the above embodiments, the description of each embodiment has its own focus. For parts that are not described or recorded in detail in a certain embodiment, reference can be made to the relevant description of other embodiments.

[0076] It should be noted that the above embodiments can be freely combined as needed. The above are only preferred implementations of the present application. It should be noted that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present application, and these improvements and modifications should also be considered as the scope of protection of the present application.

Claims

1. A ventricular simulation device, characterized in that: include: a first simulation chamber and a second simulation chamber at least partially disposed within the first simulation chamber; The first simulation chamber and the second simulation chamber are isolated from each other, and a first medium cavity is formed between the first simulation chamber and the second simulation chamber. The first simulation chamber is provided with a medium flow port connected to the first medium cavity to change the medium pressure in the first medium cavity; A second medium cavity is formed in the second simulation chamber, and a medium inlet and a medium outlet are opened in the second simulation chamber; When the medium pressure in the first medium cavity is greater than the sum of the medium pressure in the second medium cavity and the minimum pressure required for deformation of the second simulation chamber, the second simulation chamber is compressed and contracts, and the medium in the second medium cavity is discharged through the medium outlet. When the sum of the medium pressure in the first medium cavity and the minimum pressure required for deformation of the second simulation chamber is less than the medium pressure in the second medium cavity, the second simulation chamber expands, and the medium enters the second medium cavity through the medium inlet.

2. The ventricular simulation device according to claim 1, characterized in that Also includes: a first mounting frame; The second simulation chamber is mounted on the first mounting frame. The first simulation chamber is provided with an opening suitable for allowing the second simulation chamber to extend into the interior of the first simulation chamber, wherein the first mounting frame at least covers and blocks the gap between the edge of the opening of the first simulation chamber and the outer wall of the second simulation chamber.

3. The ventricular simulation device according to claim 2, characterized in that A limit platform is provided on the inner wall of the first simulation chamber, and a limit opening is formed on the limit platform for the second simulation chamber to pass through, so as to limit the position of the second simulation chamber in the first simulation chamber.

4. The ventricular simulation device according to claim 2, characterized in that There are two medium flow openings, which are symmetrically arranged on two opposite sides of the second simulation chamber; and The medium inlet and the medium outlet are both arranged on a side of the second simulation device facing the first mounting bracket, and the first mounting bracket is provided with a first joint communicating with the medium inlet and a second joint communicating with the medium outlet.

5. The ventricular simulation device according to claim 4, characterized in that The medium inlet and the medium outlet are the same opening, and the opening is provided on a side of the second simulation device facing the first mounting bracket, for connecting the first joint and the second joint.

6. The ventricular simulation device according to claim 2, characterized in that Also includes: The second mounting frame is located on a side of the first simulation chamber away from the first mounting frame. The first mounting frame and the second mounting frame jointly clamp the first simulation chamber to fix the first simulation chamber and the second simulation chamber.

7. The ventricular simulation device according to claim 6, characterized in that The first mounting bracket and the second mounting bracket are provided with a plurality of fastening holes, and fasteners pass through the fastening holes on the first mounting bracket and the fastening holes on the second mounting bracket in sequence to fix the first mounting bracket and the second mounting bracket together.

8. The ventricular simulation device according to claim 6, characterized in that The first mounting frame includes a first fixing plate and a first docking plate arranged at an angle, the first fixing plate is used to install the second simulation chamber, and the first docking plate is used to dock with an external structure; and / or, The second mounting frame includes a second fixing plate and a second docking plate arranged at an angle, the second fixing plate and the first fixing plate jointly clamp the first simulation chamber, and the second docking plate is used for docking with an external structure.

9. The ventricular simulation device according to any one of claims 1 to 8, characterized in that: The medium in the first medium cavity is gas, and the medium flow port is externally connected to an air pump; the medium in the second medium cavity is liquid.

10. An extracorporeal circulation simulation system, characterized in that: include: An air pump, an atrioventricular valve simulation device, an aortic valve simulation device, and a ventricular simulation device as described in any one of claims 1 to 9, wherein the medium flow port is externally connected to the air pump, the air pump is used to control the air pressure in the first medium cavity, the medium inlet is connected to the atrioventricular valve simulation device, and the medium outlet is connected to the aortic valve simulation device.