Ventricular simulation device and in-vitro amplification test system

Abstract

The utility model discloses a ventricle simulation device and an in-vitro amplification test system. The ventricle simulation device comprises a simulation ventricle, a mounting frame and a guide rail sliding block assembly. The simulated ventricle is provided with a ventricle cavity, the mounting rack is used for mounting the simulated ventricle, and the guide rail slide block assembly comprises a guide rail and a slide block and is arranged between the simulated ventricle and the mounting rack to realize relative sliding between the simulated ventricle and the mounting rack. A user can realize connection and disconnection between the simulation ventricle and other components by moving the simulation ventricle, or the simulation ventricle is utilized to drive a linkage component to be connected and disconnected with other components, rapid connection and disconnection of an in-vitro amplification test loop can be realized, and the test efficiency is improved under the condition that the performance test requirement of a catheter pump model is met. And the rapid dismounting and replacement of the conduit pump model in the in-vitro amplification test system are facilitated.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a ventricular simulation device and an external amplification testing system. Background Technology

[0002] Cardiovascular diseases have high incidence and mortality rates, making them one of the most concerning diseases threatening human health. Heart failure, as the end-stage manifestation of structural heart disease, is particularly severe. To support the heart's pumping function in heart failure patients, traditional implantable left ventricular assist devices (LVADs) are commonly used to maintain left ventricular function. Meanwhile, interventional ventricular assist devices (PVADs) are simple, convenient, and have small surgical incisions, often used to support patients with acute heart failure. Currently, PVADs are mainly used in two areas of clinical application for acute heart failure: cardiogenic shock and percutaneous coronary intervention (PCI). Specifically, cardiogenic shock, as an acute symptom, requires highly efficient support for the heart's pumping function, which PVADs can effectively assist with; and during PCI, which is prone to malignant hemodynamic reactions, cardiac assist devices can be used to restore left ventricular function in the short term. Therefore, many researchers in related fields are focusing their attention on PVADs, making them a new trend.

[0003] As a medical device that assists in ventricular pumping and stabilizes patient hemodynamics, the pumping performance of the catheter pump in a PVAD system is crucial for improving the overall performance of the device. The impeller structure and the shape of the outflow chamber window significantly influence pumping function. Therefore, hydrodynamic experiments are necessary to evaluate the performance of catheter pumps with different impeller and outflow chamber structures. Using pre-made catheter pumps results in high costs and limited component manufacturing precision; designing a scale-up experiment can effectively avoid these drawbacks. When building a scale-up experimental system, the device needs to meet the performance testing requirements of catheter pumps under different afterloads and speeds, and also needs to allow for quick disassembly and replacement of the impeller and outflow chamber. Furthermore, considering the large size of the experimental device, convenient and simple methods are required for the supply and demand of liquids within the tubing.

[0004] Therefore, improvements are needed to the design of related devices and pipelines for scale-up experiments to meet testing requirements, while also providing the ability to quickly disassemble and replace the impeller and the outflow chamber. Utility Model Content

[0005] The purpose of this application is to provide a ventricular simulation device and an external amplification testing system that meets the performance testing requirements of catheter pump models while also having the function of quick disassembly and replacement of catheter pump models.

[0006] The technical solution provided by this utility model is as follows:

[0007] A ventricular simulation device, suitable for an external amplification testing system, comprising:

[0008] It simulates a ventricle and has ventricular chambers;

[0009] Mounting bracket for mounting the simulated ventricle;

[0010] A guide rail and slider assembly includes a guide rail and a slider, one of which is fixed to the simulated ventricle, and the other of which is fixed to the mounting bracket. The guide rail and the slider are slidably engaged to achieve relative sliding between the simulated ventricle and the mounting bracket.

[0011] In some embodiments, the guide rail is fixed to the mounting frame, and the slider is fixed to the simulated ventricle; and the slider is provided with a locking element for locking the slider to limit the relative position between the simulated ventricle and the mounting frame.

[0012] In some embodiments, the number of guide rails is two, and the two guide rails are arranged in parallel.

[0013] The number of sliders is at least two, and at least one slider is slidably mounted on each of the two guide rails.

[0014] In some embodiments, the simulated ventricle has opposing first and second sides, each side having a shelf; and the number of sliders is four, arranged in pairs at the bottom of the shelves on the first and second sides.

[0015] In some embodiments, the simulated ventricle is provided with a docking structure for docking with a simulated artery; and / or, the simulated ventricle is provided with an interface for docking with a supply line and / or a thermostatic line, the supply line being used to infuse fluid into the ventricular cavity, and the thermostatic line being used to allow the fluid in the ventricular cavity to flow through a cooling plate to maintain a stable temperature of the fluid in the ventricular cavity; and / or, the simulated ventricle is provided with a perforation for external devices to pass through.

[0016] In some embodiments, the docking structure includes a partition that connects the simulated ventricle and the simulated artery and serves to simulate an arterial valve.

[0017] This application also provides an external amplification testing system, including:

[0018] A ventricular simulation device, a simulated artery, and simulated tubing, wherein the ventricular simulation device is the ventricular simulation device provided in any of the above embodiments;

[0019] The simulated ventricle, simulated artery, and simulated tubing are connected end to end to form a circuit; the simulated artery includes a first arterial segment and a second arterial segment.

[0020] The first arterial segment is connected to the simulated ventricle, and the simulated ventricle slides along the extension direction of the guide rail, thereby causing the first arterial segment to dock with or detach from the second arterial segment.

[0021] In some embodiments, the simulated artery has a penetration channel extending from the second arterial segment to the first arterial segment, which is suitable for the insertion of a catheter pump model.

[0022] In some embodiments, the external amplification testing system further includes:

[0023] A fluid supply device for perfusing fluid into the ventricular cavity and the arterial segment.

[0024] In some embodiments, the fluid supply device is provided with a supply line, the end of which is connected to a three-way ball valve, which is connected to two shunt lines that are respectively connected to the ventricular cavity and the simulated artery.

[0025] In some embodiments, the external amplification testing system further includes:

[0026] Gas supply equipment;

[0027] The ventricular cavity and the simulated artery are connected by a trachea, which is adapted to connect to the gas supply device to deliver high-pressure gas to the ventricular cavity and the simulated artery, thereby emptying the fluid in the external amplification test system to the fluid supply device; and the trachea is provided with a gas valve for opening and closing the trachea.

[0028] In some embodiments, the external amplification testing system further includes:

[0029] The temperature control system includes a cooling element, a thermocouple, a thermometer, a first thermostatic pipeline, and a second thermostatic pipeline;

[0030] The thermometer is inserted into the ventricular cavity to measure the temperature of the fluid inside the ventricular cavity; the thermocouple is inserted into the ventricular cavity to heat the fluid inside the ventricular cavity; the first thermostatic pipeline and the second thermostatic pipeline are connected to the ventricular cavity, the first thermostatic pipeline is used to supply the fluid inside the ventricular cavity to the cooling plate, the cooling plate is used to cool the fluid, and the second thermostatic pipeline is used to supply the cooled fluid to flow back to the ventricular cavity.

[0031] In some embodiments, the ventricular cavity and the simulated artery are equipped with pressure sensors; and / or, the simulated tubing is equipped with a flow sensor and a throttle valve.

[0032] The technical advantages of this application are as follows:

[0033] 1. In this application, by setting the guide rail slider assembly, the simulated ventricle can be moved, which helps the user to quickly connect and disconnect the external amplification test circuit (the circuit formed by connecting the simulated ventricle, simulated artery and simulated tubing in sequence), so as to realize the quick disassembly and replacement of the catheter pump model in the external amplification test system while meeting the performance test requirements of the catheter pump model.

[0034] 2. In this application, the simulated artery includes a first arterial segment and a second arterial segment. The catheter pump model passes through the first arterial segment from the second arterial segment, and the first arterial segment is connected to the simulated ventricle. Thus, when the user slides the simulated ventricle away from the second arterial segment, the first arterial segment can be moved along with it, thereby disconnecting the simulated artery from the first and second arterial segments, which facilitates the quick disassembly and replacement of the catheter pump model. Attached Figure Description

[0035] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0036] Figure 1 This is a three-dimensional structural schematic diagram of the ventricular simulation device provided in one embodiment of this application;

[0037] Figure 2 This is a plan view of a simulated ventricle provided in one embodiment of this application;

[0038] Figure 3 This is a schematic diagram of the external amplification testing system provided in one embodiment of this application;

[0039] Figure 4 This is a cross-sectional view of a first arterial segment, a second arterial segment, and a catheter pump model provided in one embodiment of this application;

[0040] Figure 5 This is a schematic diagram of the cannula and outflow chamber provided in one embodiment of this application;

[0041] Figure 6 This is a schematic diagram of the structure of the rotating shaft provided in one embodiment of this application.

[0042] Explanation of icon numbers:

[0043] 100. Ventricular simulation device; 110. Simulated ventricle; 120. Mounting bracket; 130. Guide rail; 140. Slider; 150. Shelf; 160. Partition; 171. First interface; 172. Second interface; 173. Third interface; 174. Fourth interface; 175. Fifth interface; 181. First perforation; 182. Second perforation; 183. Third perforation; 190. Fastening hole;

[0044] 200. Simulated artery; 210. First arterial segment; 220. Second arterial segment; 230. Through passage; 240. Third arterial segment;

[0045] 300. Simulated piping;

[0046] 400. Model of a duct pump; 410. Insertion tube; 420. Outflow chamber; 421. Outflow window; 430. Impeller; 440. Shaft; 441. Shaft cover; 450. Motor;

[0047] 500. Fluid supply equipment; 510. Liquid storage tank; 520. Supply pipeline; 530. Three-way ball valve; 540. Diversion pipeline;

[0048] 600. Gas supply equipment; 610. Gas pipes; 620. Gas valves;

[0049] 700. Temperature control system; 710. First thermostatic piping; 720. Second thermostatic piping;

[0050] 801. Pressure sensor; 802. Flow sensor; 803. Throttling valve; 804. Data acquisition instrument. Detailed Implementation

[0051] In the following description, specific details such as particular system architectures and techniques are set forth for illustrative purposes and not for limitation, in order to provide a thorough understanding of the embodiments of this application. However, those skilled in the art will understand that this application can also be implemented in other embodiments without these specific details. In other instances, detailed descriptions of well-known systems, apparatuses, circuits, and methods have been omitted so as not to obscure the description of this application with unnecessary detail.

[0052] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the specific implementation methods of this application will be described below with reference to the accompanying drawings. Obviously, the drawings described below are merely some embodiments of this application. For those skilled in the art, other drawings and other implementation methods can be obtained based on these drawings without any creative effort.

[0053] To keep the drawings concise, each drawing only schematically shows the parts relevant to this application, and they do not represent the actual structure of the product. Furthermore, for ease of understanding, in some drawings, only one of the components with the same structure or function is schematically shown, or only one is labeled. In this document, "one" not only means "only one," but can also mean "more than one."

[0054] It should also be further understood that the term “and / or” as used in this application specification and the appended claims means any combination of one or more of the associated listed items and all possible combinations, and includes such combinations.

[0055] In this document, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium; and they can refer to the internal connection between two components. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0056] In the embodiments shown in the accompanying drawings, the directional indications (such as up, down, left, right, front, and back) used to explain the structure and movement of the various components of this application are relative rather than absolute. These descriptions are appropriate when these components are in the positions shown in the drawings. If the description of the positions of these components changes, these directional indications also change accordingly.

[0057] Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0058] To address the need for performance testing of duct pumps under different afterloads and speeds when building a scaled-up experimental system, and to provide a ventricular simulation device and an external scaled-up testing system, this application provides a ventricular simulation device and an external scaled-up testing system. This system can test the performance of duct pumps with different impeller and outflow chamber structures under different afterload conditions. At the same time, the duct pump can adjust the speed, and the impeller and outflow chamber structures can be quickly and easily disassembled and assembled.

[0059] The following description is in conjunction with the accompanying drawings:

[0060] Please refer to Figure 3 and Figure 4 This application provides an external amplification testing system, comprising a ventricular simulation device 100, a simulated artery 200, and a simulated conduit 300. The ventricular simulation device 100, simulated artery 200, and simulated conduit 300 are connected end-to-end to form a loop, which is the external amplification testing loop. A catheter pump model 400 is inserted into the simulated artery 200, with its impeller 430 and outflow chamber 420 facing the ventricular simulation device 100. A motor 450 is externally connected to the catheter pump model 400, and the power output shaft of the motor 450 is driven by the impeller 430, enabling the impeller 430 to rotate and thus realizing the pumping function of the catheter pump model 400.

[0061] In the cardiovascular system, large artery blood pressure, such as aortic pressure and pulmonary artery pressure, represents the afterload of the left and right ventricles. In this embodiment, a throttle valve 803 is installed on the simulated tubing 300. By adjusting the throttle valve 803, the fluid flow pressure in the simulated artery 200 is changed, thereby placing the external amplified test circuit under different afterload conditions. Performance curves of the catheter pump model 400 under different afterload conditions can then be obtained through calculation. Conversely, by replacing different catheter pump models 400, the performance of catheter pumps with different impeller 430 and outflow chamber 420 structural designs under different afterload conditions can be tested.

[0062] In one specific embodiment, see Figure 1 A ventricular simulation device 100, applicable to the aforementioned external amplification testing system, includes a simulated ventricle 110, a mounting frame 120, and a guide rail slider 140 assembly. The mounting frame 120 is used to mount the simulated ventricle 110, which has a ventricular cavity and can be connected to the aforementioned simulated artery 200 and simulated tubing 300 to form an external amplification testing circuit. The guide rail slider 140 assembly includes a guide rail 130 and a slider 140, wherein one of the guide rail 130 and the slider 140 is fixed to the simulated ventricle 110, and the other is fixed to the mounting frame 120. The guide rail 130 and the slider 140 slide together to achieve relative sliding between the simulated ventricle 110 and the mounting frame 120.

[0063] In this embodiment, the sliding of the simulated ventricle 110 is achieved by setting the guide rail slider 140 component, so that when the user disassembles and replaces the catheter pump model 400, the simulated ventricle 110 can be moved to quickly connect and disconnect the external amplification test circuit. This makes it convenient for the user to remove the catheter pump model 400 from the simulated artery 200, thereby achieving quick disassembly and replacement of the catheter pump model 400 in the external amplification test system while meeting the performance testing requirements of the catheter pump model 400.

[0064] Specifically, the guide rail 130 is fixed to the mounting bracket 120, and the slider 140 is fixed to the simulated ventricle 110. Furthermore, the slider 140 is equipped with a locking element to lock the slider 140, thereby limiting the relative position between the simulated ventricle 110 and the mounting bracket 120, ensuring that the simulated ventricle 110 can be stably maintained in the desired position. Especially when the external amplification test circuit is connected, the locking element ensures the long-term stable operation of the external amplification test system.

[0065] Preferably, the simulated ventricle 110 is provided with a docking structure for docking with the simulated artery 200. This docking structure includes a partition 160, which connects the simulated ventricle 110 and the simulated artery 200, and also simulates an aortic valve, enabling unidirectional fluid flow in the external amplification test circuit and preventing fluid from flowing back from the simulated artery 200 to the ventricular cavity. Specifically, the simulated ventricle 110 has fastening holes 190 at the connection position with the simulated artery 200. Preferably, there are 12 fastening holes 190, evenly spaced, through which fasteners pass to lock the partition 160 to the simulated ventricle 110. The fasteners can be screws, bolts, nuts, etc., and are not limited herein, all within the scope of protection of this application.

[0066] In addition, see Figure 2 The simulated ventricle 110 should also be equipped with an interface for connecting to external pipelines for connection with corresponding accessories. For example, the simulated pipeline 300, the simulated ventricle 110 needs to be equipped with a first interface 171 for connecting to the pipeline; the fluid supply device 500, used to infuse fluid into the ventricular cavity and arterial segment, the simulated ventricle 110 may have a second interface 172 for connecting to the supply pipeline 520 on it; the temperature control system 700, used to maintain the constant temperature of the fluid in the external amplification test circuit, the simulated ventricle 110 may have a third interface 173 and a fourth interface 174 for connecting to the constant temperature pipeline on it, so that the fluid in the ventricular cavity can flow out through the constant temperature pipeline to the cooling chip and then flow back into the ventricular cavity to complete the fluid cooling. Conversely, the simulated ventricle 110 may also be provided with perforations for external devices to pass through. For example, a first perforation 181 for a thermometer and a perforation 182 for a thermocouple are provided on the simulated ventricle 110 so that the temperature control system 700 can maintain the fluid temperature inside the simulated ventricle 110 at the required test conditions. A third perforation 183 is provided on the simulated ventricle 110 for a pressure sensor 801 to pass through, so as to detect the fluid pressure before the duct pump is pumped, so as to analyze the performance of the duct pump model 400.

[0067] In one specific embodiment, there may be one guide rail 130 and at least one slider 140, located at the center of the bottom of the simulated ventricle 110 and arranged along an axis, which is beneficial to the stable movement of the simulated ventricle 110. Preferably, there may be two sliders 140, which are arranged one behind the other along the central axis of the bottom of the simulated ventricle 110 and slide sequentially on the guide rail 130.

[0068] In actual production, see Figure 2 and Figure 3The number of guide rails 130 can also be two, with the two guide rails 130 arranged in parallel; correspondingly, the number of sliders 140 is at least two, and at least one slider 140 is slidably mounted on each of the two guide rails 130. In this embodiment, by setting two sets of guide rails 130 and sliders 140, compared to setting only one set of guide rails 130 and sliders 140, it is more conducive to simulating the stable movement of the ventricle 110.

[0069] Specifically, the simulated ventricle 110 has opposing first and second sides, each with a shelf 150. A slider 140 is fixed below the shelf 150, and moves along the guide rail 130 to move the simulated ventricle 110. This embodiment, by providing guide rails 130 and sliders 140 on opposing sides of the simulated ventricle 110, further improves the stability of the simulated ventricle 110's movement. Preferably, four sliders 140 are provided, arranged in pairs at the bottom of the shelves 150 on the first and second sides, respectively engaging with two guide rails 130.

[0070] See Figure 3 This application also provides an external amplification testing system, including a ventricular simulation device 100, a simulated artery 200, and a simulated conduit 300, wherein the ventricular simulation device 100 is the ventricular simulation device 100 provided in any of the above embodiments. Specifically, the simulated ventricle 110, the simulated artery 200, and the simulated conduit 300 are connected end-to-end to form an external amplification testing circuit. The simulated ventricle 110 is connected to the simulated artery 200 via a partition 160 and to the simulated conduit 300 via a first interface 171. In actual production, if the simulated ventricle 110 is used to simulate the left ventricle, then the simulated artery 200 is used to simulate the aorta; if the simulated ventricle 110 is used to simulate the right ventricle, then the simulated artery 200 is used to simulate the pulmonary artery. The simulated artery 200 includes a first arterial segment 210 and a second arterial segment 220, and the simulated artery 200 is provided with a penetration channel 230 extending from the second arterial segment 220 to the first arterial segment 210, which is suitable for the catheter pump model 400 to be inserted.

[0071] This embodiment utilizes the structure of the simulated ventricle 110 sliding on the mounting frame 120. By moving the simulated ventricle 110, it can be quickly disconnected from the simulated artery 200, which is beneficial for users to disassemble and replace the catheter pump model 400 inserted in the simulated artery 200.

[0072] In a preferred embodiment, see Figure 3 and Figure 4The simulated ventricle 110 can also move the first arterial segment 210. That is, the first arterial segment 210 is connected to the simulated ventricle 110, and the simulated ventricle 110 slides along the extension direction of the guide rail 130, thereby driving the first arterial segment 210 to engage with or disengage from the second arterial segment 220, which is more conducive to the rapid replacement of the catheter pump model 400. At this time, the first arterial segment 210 and the second arterial segment 220 can be assembled in the form of a socket flange and radially sealed by an O-ring, and then radially fixed by fasteners mounted on the flange edge, wherein the fasteners are preferably bolts and nuts; correspondingly, the simulated ventricle 110 and the first arterial segment 210 are preferably fixed and assembled by bolts and nuts.

[0073] Specifically, see Figures 4 to 6 The catheter pump model 400 preferably includes a cannula 410, an outlet chamber 420, an impeller 430, and a power system. The cannula 410 is fixed to the partition 160 with fasteners. The outlet chamber 420 has an outlet window 421 connected to the end of the cannula 410 away from the simulated ventricle 110. The power system includes an external motor 450, a speed controller, and a rotating shaft 440. The motor 450 has a power output shaft that is connected to the rotating shaft 440. The end of the rotating shaft 440 away from the electrode is fixed to the impeller 430 by threads. Thus, the operation of the motor 450 drives the impeller 430 to rotate, pumping the fluid that enters the catheter pump model 400 through the cannula 410 out through the outlet window 421. The speed controller is used to change the driving speed of the motor 450 to meet different testing requirements.

[0074] In this embodiment, the cannula 410 is preferably fixed to the partition 160 by bolts and nuts, and an O-ring is fitted on the bolt to prevent leakage through the through hole. Specifically, the end of the cannula 410 away from the outflow chamber 420 is fixed to the side of the partition 160 facing the simulated ventricle 110. At this time, the catheter pump model 400 is installed in the simulated ventricle 110, the first arterial segment 210 and the second arterial segment 220, which can simulate the transvalvular pumping of the catheter pump.

[0075] The insertion tube 410 and the outflow chamber 420 are preferably connected by threads, and the insertion tube 410 has a sealing ring groove on the side of the thread away from the outflow chamber 420. With the help of an O-ring, it can provide an axial seal to prevent leakage from the insertion tube 410. The end of the rotating shaft 440 away from the electrode is also provided with a shaft cover 441. The shaft cover 441 is connected to the through channel 230 by threads, and the end of the outflow chamber 420 away from the insertion tube 410 is inserted into the shaft cover 441 and is equipped with a sealing ring to prevent leakage.

[0076] Thus, when the catheter pump needs to be disassembled and replaced, the bolts and nuts between the first arterial segment 210 and the second arterial segment 220 are removed, and the simulated ventricle 110 is slid, causing the first arterial segment 210 to separate from the second arterial segment 220. Separation also occurs between the outflow chamber 420 and the shaft cover 441. That is, the first arterial segment 210 moves the cannula 410 and the outflow chamber 420 together, while the impeller 430, shaft cover 441, and shaft 440 remain stationary along with the second arterial segment 220. At this point, the structure of the catheter pump model 400 can be changed simply by unscrewing the outflow chamber 420 and replacing the impeller 430. This allows for testing of the catheter pump performance under different afterload conditions with different impeller 430 and outflow chamber 420 structural designs. After replacement, the simulated ventricle 110 can be pushed back in, and the first arterial segment 210 and the second arterial segment 220 can be connected with bolts and nuts. This achieves the connection and fixation between the outflow chamber 420 and the shaft cover 441, and between the first arterial segment 210 and the second arterial segment 220. The assembly and disassembly are convenient, providing a low-cost and easy-to-operate solution for catheter pump performance research.

[0077] Among them, the geometry, wall thickness, inner diameter of the outflow window 421 in the outflow chamber 420, as well as the length of the insertion tube 410, should be scaled up to a certain extent to match the corresponding characteristics of the original tubing pump to ensure the accuracy of the test results.

[0078] Preferably, the first arterial segment 210 is made of a transparent material so that the rotation of the impeller 430 in the catheter pump model 400 can be observed.

[0079] In one specific embodiment, see Figure 3 The external amplification testing system also includes a fluid supply device 500 for perfusing fluid into the ventricular cavity and arterial segment. The fluid supply device 500 includes a reservoir 510, which is connected to a supply line 520, divided into two branches that connect to the ventricular cavity and the simulated artery 200 respectively. Specifically, the supply line 520 can be connected to the ventricular cavity via a second interface 172 on the simulated ventricle 110.

[0080] Specifically, a three-way ball valve 530 is connected to the end of the supply line 520. This three-way ball valve 530 connects to two shunt lines 540, which are respectively connected to the ventricular cavity and the second arterial segment 220. The shunt lines 540, the simulated ventricle 110, and the second arterial segment 220 are connected by an externally threaded pagoda connector. Preferably, the second interface 172 on the simulated ventricle 110 is located below the simulated ventricle 110, and this second interface 172 is an internally threaded interface. Correspondingly, the second arterial segment 220 also has a corresponding internally threaded interface below it, so that fluid (liquid) can quickly enter and exit the external amplification test circuit. In actual production, the fluid supply device 500 supports the inflow and outflow of approximately 30L of liquid in the entire external amplification test circuit.

[0081] Specifically, the external amplification testing system further includes a gas supply device 600, which works in conjunction with a fluid supply device 500 to infuse and drain fluid within the external amplification testing circuit. In this embodiment, both the ventricular cavity and the simulated artery 200 are connected to a trachea 610. This trachea 610 can be connected to the atmosphere or to the gas supply device 600. Furthermore, the trachea 610 is equipped with a valve 620 for opening and closing the trachea 610. Specifically, the simulated ventricle 110 has a fifth interface 175, and the trachea 610 is connected to this fifth interface 175 to achieve communication with the ventricular cavity.

[0082] When liquid needs to be injected into the external amplification test circuit, there is an elevation difference Δh between the liquid storage tank 510 and the entire external amplification test circuit. The bottom of the liquid storage tank 510 is higher than the top of the external amplification test circuit. The three-way ball valve 530 is opened, and liquid is injected into the ventricular cavity and simulated artery 200 simultaneously through the shunt pipe 540 using hydraulic pressure. At this time, the gas valve 620 is connected to the atmosphere. During the amplification test experiment, the three-way ball valve 530 and the gas valve 620 are closed, and the entire external amplification test circuit is sealed. When draining the liquid, the three-way ball valve 530 is opened, and the gas valve 620 is connected to the high-pressure gas supply device 600. The gas pressure is used to push the liquid in the external amplification test circuit back into the liquid storage tank 510, making the liquid loading and unloading convenient and simple. After the liquid is drained, close the air valve 620 and the three-way ball valve 530. The user can slide the simulated ventricle 110 to disassemble and replace the outflow chamber 420 and the impeller 430. When the next test begins, reopen the three-way ball valve 530 to connect the air valve 620 to the atmosphere.

[0083] Furthermore, the external amplification testing system also includes a temperature control system 700, which includes a cooling element, a thermocouple, a thermometer, a first thermostatic conduit 710, and a second thermostatic conduit 720. The thermometer is inserted into the ventricular cavity through a first perforation 181 via a cable sealing device to measure the temperature of the fluid inside the ventricular cavity; the thermocouple is also inserted into the ventricular cavity through a second perforation 182 using the same sealing method to heat the fluid inside the ventricular cavity; the first thermostatic conduit 710 and the second thermostatic conduit 720 connect the ventricular cavity and the cooling element. Specifically, the first thermostatic conduit 710 is connected to a third interface 173 on the simulated ventricle 110 for the fluid inside the ventricular cavity to flow to the cooling element, which cools the fluid; the second thermostatic conduit 720 is connected to a fourth interface 174 on the simulated ventricle 10 for the cooled fluid to flow back into the ventricular cavity via the second thermostatic conduit 720. The second thermostatic pipeline 720 is externally connected to a water pump for actively extracting and pumping fluid back into the ventricular cavity. Specifically, the temperature control system 700 also includes a temperature control mainboard for controlling the cooling coil for cooling or the thermocouple for heating.

[0084] Specifically, the ventricular cavity and simulated artery 200 are also equipped with pressure sensors 801. The pressure sensor 801 can be inserted into the ventricular cavity through the third perforation 183 on the simulated ventricle 110. Correspondingly, a corresponding opening can also be made on the simulated artery 200 for the pressure sensor 801 to be inserted. The simulated pipeline 300 is equipped with a flow sensor 802 and a throttle valve 803. Adjusting the throttle valve 803 can put the entire external amplification test circuit into different afterload states. The two pressure sensors 801 and the flow sensor 802 are connected to the data acquisition instrument 804 to obtain real-time pressure and flow data, thereby obtaining the performance curve of the catheter pump model 400, which is beneficial for users to evaluate the performance of catheter pumps with different impeller structures 430 and outflow chamber 420.

[0085] Specifically, the simulated artery 200 also includes a third artery segment 240, which connects the second artery segment 220 and the simulated tubing 300. The penetration channel 230 for penetrating the catheter pump model 400 is located on the second artery segment 220. In this case, the pressure sensor 801 on the simulated artery 200 is preferably located on the third artery segment 240.

[0086] Preferably, the external amplification testing system also includes a truss assembly for constructing and securing the entire external amplification testing circuit, thereby ensuring the coaxiality of the circuit and addressing issues related to disassembly, assembly, and placement. The mounting bracket 120 for mounting the simulated ventricle 110 is part of this truss assembly.

[0087] The external amplification testing system disclosed in this application can meet the performance testing requirements of duct pumps with different backloads and different speeds. It also has the function of quick disassembly and replacement of impeller 430 and outflow chamber 420, and the liquid loading and unloading in the external amplification testing circuit is also convenient and simple.

[0088] At the start of the experiment, the impeller 430 and outflow chamber 420 models to be tested were installed: the bolts and nuts between the first arterial segment 210 and the second arterial segment 220 were removed, the slider 140 was unlocked, and the simulated ventricle 110 was slid to move the first arterial segment 210 and other components fixed thereto away from the second arterial segment 220. The impeller 430 and outflow chamber 420 to be tested were then screwed onto the rotating shaft 440 and the cannula 410, respectively. After installation, the simulated ventricle 110 was slid to move the first arterial segment 210 and other components fixed thereto toward the second arterial segment 220, the slider 140 was locked, and the bolts and nuts between the first arterial segment 210 and the second arterial segment 220 were installed, thus restoring the external amplification test circuit to a sealed state.

[0089] The second step is to fill the external amplification test circuit with liquid: open the gas valve 620 to the atmosphere, open the three-way ball valve 530 connected to the liquid storage tank 510, and use the liquid level difference to simultaneously fill the ventricular cavity and the second arterial segment 220 with liquid. After the liquid is completely filled, close the gas valve 620 and the three-way ball valve 530 to make the external amplification test circuit sealed.

[0090] The third step is temperature control: turn on the temperature control system, that is, start the external water pump, cooling element and thermocouple, set the required temperature for the experiment, and proceed to the next step after the temperature reaches the required level.

[0091] The fourth step is to conduct the formal experiment on the drive motor 450: set the speed of the external motor 450 to the speed required for the experiment, and connect the rotating shaft 440 with the speed controller and coupling to drive the rotating shaft 440 to rotate.

[0092] After completing the above operations, the impeller 430 rotates, pumping the fluid in the ventricular cavity out through the cannula 410 and outflow window 421. The fluid flows from the first arterial segment 210 to the subsequent simulated tubing 300 and back into the ventricular cavity. At this time, the throttle valve 803 is adjusted to place the external amplification test circuit under different afterload states. The two pressure sensors 801 and the flow sensor 802 are connected to the data acquisition instrument 804 to acquire real-time pressure and flow data, so as to measure the performance curve of the catheter pump model 400 under different afterload states. After recording, the motor 450 is stopped, the three-way ball valve 530 is opened, and the gas valve 620 is opened to allow high-pressure gas to be supplied. The gas pressure forces the fluid in the external test circuit back into the storage tank 510. After all the fluid is drained, the three-way ball valve 530 and the gas valve 620 are closed. If there is another model to be tested later, the above operations are repeated. This experimental device is simple to operate, fast and efficient, and supports low-cost catheter pump performance research.

[0093] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail or recorded in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0094] It should be noted that the above embodiments can be freely combined as needed. The above are merely preferred embodiments of this application. It should be pointed out that for those skilled in the art, several improvements and modifications can be made without departing from the principles of this application, and these improvements and modifications should also be considered within the scope of protection of this application.

Claims

1. A ventricular simulation device, suitable for external amplification testing systems, characterized in that, include: It simulates a ventricle and has ventricular chambers; Mounting bracket for mounting the simulated ventricle; A guide rail and slider assembly includes a guide rail and a slider, one of which is fixed to the simulated ventricle, and the other of which is fixed to the mounting bracket. The guide rail and the slider are slidably engaged to achieve relative sliding between the simulated ventricle and the mounting bracket.

2. The ventricular simulation device according to claim 1, characterized in that, The guide rail is fixed to the mounting frame, and the slider is fixed to the simulated ventricle; and the slider is provided with a locking element for locking the slider to limit the relative position between the simulated ventricle and the mounting frame.

3. The ventricular simulation device according to claim 1 or 2, characterized in that, The number of guide rails is two, and the two guide rails are arranged in parallel. The number of sliders is at least two, and at least one slider is slidably mounted on each of the two guide rails.

4. The ventricular simulation device according to claim 3, characterized in that, The simulated ventricle has a first side and a second side, both of which are provided with shelves; and the number of sliders is four, which are arranged in pairs at the bottom of the shelves on the first side and the second side.

5. The ventricular simulation device according to claim 1 or 2, characterized in that, The simulated ventricle is provided with a docking structure for docking with a simulated artery; and / or, the simulated ventricle is provided with an interface for docking with a supply pipeline and / or a thermostatic pipeline, the supply pipeline for injecting fluid into the ventricular cavity, and the thermostatic pipeline for allowing the fluid in the ventricular cavity to flow through a cooling plate to maintain a stable fluid temperature in the ventricular cavity; and / or, the simulated ventricle is provided with a perforation for external devices to pass through.

6. The ventricular simulation device according to claim 5, characterized in that, The docking structure includes a partition that connects the simulated ventricle and the simulated artery and is used to simulate an arterial valve.

7. An external amplification testing system, characterized in that, include: A ventricular simulation device, a simulated artery, and simulated tubing, wherein the ventricular simulation device is the ventricular simulation device according to any one of claims 1-6; The simulated ventricle, simulated artery, and simulated tubing are connected end to end to form a circuit; the simulated artery includes a first arterial segment and a second arterial segment. The first arterial segment is connected to the simulated ventricle, and the simulated ventricle slides along the extension direction of the guide rail, thereby causing the first arterial segment to dock with or detach from the second arterial segment.

8. The external amplification testing system according to claim 7, characterized in that, The simulated artery has a penetration channel inside, which extends from the second arterial segment to the first arterial segment and is suitable for the insertion of the catheter pump model.

9. The external amplification testing system according to claim 7, characterized in that, Also includes: A fluid supply device for perfusing fluid into the ventricular cavity and the arterial segment.

10. The external amplification testing system according to claim 9, characterized in that, The fluid supply device is provided with a supply pipeline, and a three-way ball valve is connected to the end of the supply pipeline. The three-way ball valve is connected to two shunt pipelines, which are respectively connected to the ventricular cavity and the simulated artery.

11. The external amplification testing system according to claim 9, characterized in that, Also includes: Gas supply equipment; The ventricular cavity and the simulated artery are connected by a trachea, which is adapted to connect to the gas supply device to deliver high-pressure gas to the ventricular cavity and the simulated artery, thereby emptying the fluid in the external amplification test system to the fluid supply device; and the trachea is provided with a gas valve for opening and closing the trachea.

12. The external amplification testing system according to any one of claims 7-11, characterized in that, Also includes: The temperature control system includes a cooling element, a thermocouple, a thermometer, a first thermostatic pipeline, and a second thermostatic pipeline; The thermometer is inserted into the ventricular cavity to measure the temperature of the fluid inside the ventricular cavity; the thermocouple is inserted into the ventricular cavity to heat the fluid inside the ventricular cavity; the first thermostatic pipeline and the second thermostatic pipeline are connected to the ventricular cavity, the first thermostatic pipeline is used to supply the fluid inside the ventricular cavity to the cooling plate, the cooling plate is used to cool the fluid, and the second thermostatic pipeline is used to supply the cooled fluid to flow back to the ventricular cavity.

13. The external amplification testing system according to any one of claims 7-11, characterized in that, The ventricular cavity and the simulated artery are equipped with pressure sensors; and / or, the simulated tubing is equipped with a flow sensor and a throttle valve.

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