Catheter pump model, simulated artery and extracorporeal magnification test system

CN122961660APending Publication Date: 2026-10-23SHANGHAI PHIGINE MEDICAL CO LTD
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Patent Information

Application Number
CN202510488098.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-04-17
Publication Date
2026-10-23

AI Technical Summary

Technical Problem

因此,目前大量相关领域的研究人员将目光锁定在PVAD上,PVAD成为了一股新的浪潮

Benefits of technology

[0038]1、本申请中的导管泵模型能够实现导管泵的泵送功能,同时,该导管泵模型中的管段和转轴采用可拆卸连接,通过拆开管段和转轴就能将导管泵模型拆分成两部分,一部分是设有流出窗口的管段,另一部分是叶轮和动力系统,如此便为流出窗口结构、叶轮的更换提供了空间,方便用户根据测试需要更换流出窗口结构和/或叶轮,拆装方便。

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Abstract

The application discloses a catheter pump model, a simulated artery and an extracorporeal amplification test system. The catheter pump model comprises a pipe section, an impeller and a power system. The pipe section is provided with an outflow window in a side wall, and the impeller is arranged in the pipe section and located at the outflow window. The power system comprises a rotating shaft, the impeller is installed on the rotating shaft, and the rotating shaft is detachably inserted into the pipe section. The power system drives the rotating shaft to rotate, and then drives the impeller to rotate, so as to pump out the fluid in the pipe section from the outflow window, and realize the pumping function of the catheter pump. In the application, the catheter pump model can be divided into two parts by disassembling the pipe section and the rotating shaft. One part is the pipe section provided with the outflow window, and the other part is the impeller and the power system. Users can replace the outflow window structure and / or the impeller according to test requirements, so as to meet the requirement of testing the performance of the catheter pump with different impellers and outflow window structures. The catheter pump model is convenient and fast to disassemble and assemble.
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Description

Technical Field

[0001] This application relates to the field of medical device technology, and more particularly to a catheter pump model, a simulated artery, 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 outflow chamber. Summary of the Invention

[0005] The purpose of this application is to provide a catheter pump model, a simulated artery, and an external amplification testing system that meets the performance testing requirements of the catheter pump model while also having the function of quickly disassembling and replacing the outflow window structure and impeller.

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

[0007] A duct pump model, comprising:

[0008] Pipe sections, impellers, and power systems;

[0009] The pipe section has an outlet window on its side wall, and the impeller passes through the pipe section and is located at the outlet window; the power system includes a shaft, the impeller is mounted on the shaft, and the shaft is detachably inserted into the pipe section;

[0010] The operation of the power system drives the shaft to rotate, which in turn drives the impeller to rotate, suitable for pumping the fluid in the pipe section out through the outlet window.

[0011] In some embodiments, the rotating shaft is fitted with a shaft cover, which is adapted to be inserted into the pipe section and socketed with the pipe section.

[0012] In some embodiments, the pipe segment includes a fixed segment and a detachable segment, the detachable segment being detachably installed on the fixed segment, and the outlet window being provided on the side wall of the detachable segment away from the fixed segment; and the fixed segment having a connecting portion at the end away from the detachable segment for connecting with external components.

[0013] In some embodiments, the fixed section and the detachable section are connected by a threaded connection;

[0014] and / or

[0015] The impeller and the shaft are connected by a threaded connection.

[0016] In some embodiments, the power system further includes a motor, a coupling, and a speed regulator, the motor having a power output shaft, the coupling connecting the power output shaft and the rotating shaft, and the speed regulator for adjusting the rotational speed of the power output shaft.

[0017] This application also provides a simulated artery, suitable for insertion into the catheter pump model provided in any of the above embodiments, including:

[0018] First arterial segment and second arterial segment;

[0019] The first arterial segment is adapted to dock with a simulated ventricle, and the second arterial segment is provided with a through-passage, which extends from the second arterial segment to the first arterial segment and is adapted for the shaft to pass through.

[0020] The pipe segment is fixedly installed on the first arterial segment, the rotating shaft is located on the second arterial segment, and the first arterial segment and the second arterial segment are detachably connected; when the first arterial segment and the second arterial segment are separated, the pipe segment follows the first arterial segment, and the rotating shaft and the impeller follow the second arterial segment.

[0021] In some embodiments, the rotating shaft is fitted with a shaft cover, and the shaft cover is threadedly connected to the end of the through-channel facing the first arterial segment.

[0022] In some embodiments, the first arterial segment has a first connecting flange at one end facing the second arterial segment, and the second arterial segment has a second connecting flange at one end facing the first arterial segment. Fasteners are adapted to pass through the first connecting flange and the second connecting flange to fix the first arterial segment and the second arterial segment together.

[0023] This application also provides an in vitro amplification testing system suitable for in vitro amplification testing of the catheter pump model provided in any of the above embodiments, including:

[0024] Truss assembly and simulated ventricles, simulated arteries and simulated tubing disposed on the truss assembly;

[0025] The simulated ventricle, simulated artery, and simulated tubing are connected end to end to form a loop, and the simulated artery is the simulated artery provided in any of the above embodiments.

[0026] In some embodiments, a guide rail slider assembly is provided between the simulated ventricle and the truss assembly;

[0027] The guide rail and slider assembly includes a guide rail and a slider, and one of the guide rail and the slider is fixed to the simulated ventricle, while the other of the guide rail and the slider is fixed to the truss assembly. The guide rail and the slider slide together to achieve relative sliding between the simulated ventricle and the truss assembly, and the simulated ventricle is adapted to drive the first arterial segment to move.

[0028] In some embodiments, a septum is provided between the simulated ventricle and the first arterial segment, the septum connecting the simulated ventricle and the first arterial segment and serving to simulate an arterial valve; and,

[0029] The end of the tube segment away from the rotating shaft is connected to the side of the diaphragm facing the simulated ventricle.

[0030] In some embodiments, the simulated artery further includes a third arterial segment that connects the second arterial segment and the simulated tubing; and the simulated ventricle and the third arterial segment are equipped with pressure sensors, and the simulated tubing is equipped with a flow sensor and a throttle valve.

[0031] In some embodiments, the external amplification testing system further includes:

[0032] Fluid supply equipment;

[0033] 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 branch pipelines, which are respectively connected to the simulated ventricle and the second arterial segment.

[0034] In some embodiments, the external amplification testing system further includes:

[0035] Gas supply equipment;

[0036] The simulated ventricle and the second arterial segment are connected by a trachea, which is adapted to connect to the gas supply device to deliver high-pressure gas to the simulated ventricle and the simulated arterial, 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.

[0037] The technical advantages of this application are as follows:

[0038] 1. The duct pump model in this application can realize the pumping function of the duct pump. At the same time, the pipe section and the shaft in the duct pump model are detachably connected. By disassembling the pipe section and the shaft, the duct pump model can be divided into two parts: one part is the pipe section with the outlet window, and the other part is the impeller and power system. This provides space for the replacement of the outlet window structure and the impeller, making it convenient for users to replace the outlet window structure and / or the impeller according to the test needs. Disassembly and assembly are convenient.

[0039] 2. In this application, the outer sleeve of the rotating shaft is provided with a shaft cover, and the shaft cover and the pipe section are connected by a socket joint. The structural design is simple and more conducive to the quick assembly and disassembly of the impeller and the outlet window structure of the duct pump model, providing a low-cost and easy-to-operate solution for the performance research of the duct pump.

[0040] 3. In order to facilitate the disassembly and assembly of the impeller and the outlet window structure, this application sets the simulated artery to include a first arterial segment and a second arterial segment. When the two are separated, the pipe segment follows the first arterial segment, and the impeller and the power system follow the second arterial segment. In this way, the user only needs to disassemble the first arterial segment and the second arterial segment to drive the duct pump model to separate, which is simple and quick to operate.

[0041] 4. In this application, the simulated ventricle is fixedly connected to the first arterial segment and the tube segment. By setting the guide rail slider assembly, the simulated ventricle can be stably slid to drive the first arterial segment and the tube segment to move smoothly together. This realizes the quick assembly and disassembly of the impeller and the outflow window structure, and also ensures the coaxiality between the first arterial segment and the second arterial segment, as well as between the tube segment and the rotating shaft. Attached Figure Description

[0042] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments:

[0043] Figure 1This 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;

[0044] Figure 2 This is a schematic diagram of the pipe segment provided in one embodiment of the present application;

[0045] Figure 3 This is a schematic diagram of the structure of the rotating shaft and shaft cover provided in one embodiment of this application;

[0046] Figure 4 This is a schematic diagram of the external amplification testing system provided in one embodiment of this application;

[0047] Figure 5 This is a three-dimensional structural schematic diagram of the simulated ventricle and guide rail slider assembly provided in one embodiment of this application;

[0048] Figure 6 This is a plan view of a simulated ventricle provided in one embodiment of this application.

[0049] Explanation of icon numbers:

[0050] 100. Simulated ventricle; 110. Septum; 121. First interface; 122. Second interface; 123. Third interface; 124. Fourth interface; 125. Fifth interface; 131. First perforation; 132. Second perforation; 133. Third perforation;

[0051] 200. Simulated artery; 210. First arterial segment; 211. First connecting flange; 220. Second arterial segment; 221. Through passage; 222. Second connecting flange; 230. Third arterial segment;

[0052] 300. Simulated piping;

[0053] 400. Pipe pump model; 410. Pipe section; 411. Fixed section; 4111. Connection part; 412. Detachable section; 4121. Outlet window; 420. Impeller; 430. Shaft; 440. Shaft cover; 450. Motor;

[0054] 500. Fluid supply equipment; 510. Liquid storage tank; 520. Supply pipeline; 530. Three-way ball valve; 540. Diversion pipeline;

[0055] 600. Gas supply equipment; 610. Gas pipe; 620. Gas valve;

[0056] 700. Temperature control system; 710. First thermostatic piping; 720. Second thermostatic piping;

[0057] 801. Pressure sensor; 802. Flow sensor; 803. Throttling valve; 804. Data acquisition instrument;

[0058] 910. Truss assembly; 920. Guide rail; 930. Slider. Detailed Implementation

[0059] 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.

[0060] 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.

[0061] 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."

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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 duct pump model, a simulated artery, and an in vitro scaled-up testing system, this application provides a duct pump model, a simulated artery, and an in vitro scaled-up testing system. This system can test the performance of duct pumps with different impeller and outflow window structure designs under different afterload conditions. The duct pump model also allows for speed adjustment, and the impeller and outflow window structure can be quickly and easily disassembled and assembled.

[0067] The following description is in conjunction with the accompanying drawings:

[0068] Please refer to Figure 1 and Figure 4 This application provides an in vitro amplification testing system, comprising a simulated ventricle 100, a simulated artery 200, and a simulated tubing 300. The simulated ventricle 100, simulated artery 200, and simulated tubing 300 are connected end-to-end to form a loop, which is the in vitro amplification testing loop. A catheter pump model 400 is inserted into the simulated artery 200, with its impeller 420 facing the simulated ventricle 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 420, enabling the impeller 420 to rotate and thus realizing the pumping function of the catheter pump model 400.

[0069] 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 amplification test circuit under different afterload conditions. Performance curves of the catheter pump model 400 under different afterload conditions can then be obtained through calculation, providing a basis for catheter pump performance research. Conversely, by changing the impeller 420 and the outflow window 4121 structure, the performance of catheter pumps with different impeller 420 and outflow window 4121 structure designs under different afterload conditions can be tested.

[0070] In one specific embodiment, see Figures 1 to 3A duct pump model 400 includes a pipe section 410, an impeller 420, and a power system. The pipe section 410 has an outlet window 4121 on its side wall. The impeller 420 passes through the pipe section 410 and is preferably located at the outlet window 4121. The power system includes a shaft 430, on which the impeller 420 is mounted. By driving the shaft 430 to rotate, the impeller 420 can be rotated, thereby pumping the fluid in the pipe section 410 out through the outlet window 4121, thus realizing the pumping function of the duct pump.

[0071] In this embodiment, pipe segment 410 is used to simulate the cannulation and outflow chamber portions of a tubing pump. The outflow chamber portion is the area in pipe segment 410 with an outflow window 4121, while the cannulation portion is the remaining area in pipe segment 410. The geometry, wall thickness, inner diameter, and cannulation length of the outflow window 4121 in the tubing pump model 400 should maintain a certain magnification ratio with the corresponding characteristics of the original tubing pump to improve the accuracy of data from in vitro magnification tests.

[0072] The rotating shaft 430 is detachably inserted into the pipe section 410. By disassembling the rotating shaft 430 and the pipe section 410, the duct pump can be divided into two parts: one part is the pipe section 410 with the outlet window 4121, and the other part is the impeller 420 and the power system. This provides space for replacing the outlet window 4121 structure and / or the impeller 420, allowing users to easily replace the outlet window 4121 structure and / or the impeller 420 according to testing needs. Conversely, after replacing the required outlet window 4121 structure and / or impeller 420, the rotating shaft 430 can be reinserted into the pipe section 410 to reassemble the duct pump model 400 for subsequent testing. The assembly and disassembly are convenient and quick.

[0073] Preferably, the rotating shaft 430 is fitted with a shaft cover 440, which is adapted to insert into and connect with the pipe section 410. A sealing ring is provided between the shaft cover 440 and the pipe section 410 to prevent leakage. In this way, the user can assemble and disassemble the duct pump model 400 simply by inserting or removing the rotating shaft 430 or the pipe section 410, providing space for the replacement of the outlet window 4121 structure and the impeller 420. The structural design is simple and facilitates the rapid assembly and disassembly of the impeller 420 and the outlet window 4121 of the duct pump model 400, providing a low-cost and easy-to-operate solution for duct pump performance research. Considering the presence of the power system, in actual use, it is preferable to insert or remove the pipe section 410 while keeping the rotating shaft 430 and related components stationary, making operation even simpler.

[0074] Specifically, see Figure 2The pipe section 410 includes a fixed section 411 and a detachable section 412. The detachable section 412 is detachably installed on the fixed section 411, and an outlet window 4121 is provided on the side wall of the end of the detachable section 412 away from the fixed section 411. At this time, the outlet chamber portion of the pipe section 410 is the area of ​​the end of the detachable section 412 away from the fixed section 411, and this area is connected to the shaft cover 440. The remaining area of ​​the detachable section 412, together with the fixed section 411, forms the insertion part. The fixed section 411 has a connecting part 4111 at the end away from the detachable section 412 for connecting with external components, so that the user can move the pipe section 410.

[0075] Preferably, the fixed section 411 and the detachable section 412 are connected by a threaded connection, facilitating easy assembly and disassembly. Users can easily change different outflow chambers by rotating the detachable section 412. In this case, the fixed section 411 has a sealing ring groove on the side of the thread away from the detachable section 412, which, in conjunction with an O-ring, provides an axial seal to prevent leakage from the insertion tube. Similarly, the impeller 420 and the shaft 430 are also connected by a threaded connection, allowing for easy assembly and disassembly by rotating the impeller 420, making operation simple and quick.

[0076] Specifically, see Figure 1 and Figure 4 The power system also includes a motor 450, a coupling, and a speed controller. The motor 450 has a power output shaft, and the coupling connects the power output shaft and the rotating shaft 430, so that the motor 450 can drive the rotating shaft 430 to rotate and thus drive the impeller 420 to rotate. The speed controller is used to adjust the rotation speed of the power output shaft in order to meet different testing requirements.

[0077] For instructions on assembling and disassembling the impeller 420 and the outlet chamber, please refer to [link / reference]. Figure 1 and Figure 4 This application also provides a simulated artery 200, including a first arterial segment 210 and a second arterial segment 220. The first arterial segment 210 is adapted to dock with a simulated ventricle 100, and the second arterial segment 220 has a through-passage 221 extending from the second arterial segment 220 to the first arterial segment 210, adapted for the catheter pump model 400 provided in any of the above embodiments to pass through. A tube segment 410 is fixedly installed in the first arterial segment 210, and a rotating shaft 430 is disposed in the second arterial segment 220, and the first arterial segment 210 and the second arterial segment 220 are detachably connected. When the first arterial segment 210 and the second arterial segment 220 are separated, the tube segment 410 follows the first arterial segment 210, and the rotating shaft 430 and impeller 420 follow the second arterial segment 220, thereby realizing the disassembly of the catheter pump model 400.

[0078] In this embodiment, the motor 450 is externally mounted on the simulated artery 200. Specifically, one end of the rotating shaft 430 connected to the motor 450 extends outside the simulated artery 200 and is connected to the motor 450. The shaft cover 440 covering the rotating shaft 430 is threadedly connected to the end of the through-channel 221 facing the first arterial segment 210. The direction of the thread is opposite to the rotation direction of the impeller 420, ensuring that the impeller 420 and the rotating shaft 430 can be stably connected to and rotate relative to the second arterial segment 220. At this time, the end of the rotating shaft 430 connected to the impeller 420 can extend from the through-channel 221 into the first arterial segment 210, providing space for the installation of the impeller 420 and facilitating its disassembly and replacement.

[0079] In contrast, the connecting part 4111 on the fixed section 411 is connected to the end of the first arterial section 210 facing the simulated ventricle 100 by a fastener. The fastener can be a screw, bolt, nut, screw, etc., which is not limited here and is within the protection scope of this application.

[0080] Specifically, see Figure 1 , Figure 4 and Figure 5 A partition 110 is provided between the simulated ventricle 100 and the first arterial segment 210. This partition 110 connects the simulated ventricle 100, the first arterial segment 210, and the connecting part 4111. It can also be used to simulate an aortic valve, realizing the function of unidirectional fluid flow in the external amplification test circuit and preventing fluid from flowing back from the simulated artery 200 to the simulated ventricle 100. In this embodiment, the connecting part 411 is fixedly assembled to the side of the partition 110 facing the simulated ventricle 100 by bolts and nuts. The simulated ventricle 100 and the first arterial segment 210 are also preferably fixedly assembled by bolts and nuts, and the aforementioned bolts are all fitted with O-ring seals to prevent leakage through the through holes. At this time, the catheter pump model 400 is installed in the simulated ventricle 100, the first arterial segment 210, and the second arterial segment 220, which can simulate the transvalvular pumping of the catheter pump.

[0081] Preferably, the first arterial segment 210 and the second arterial segment 220 can be assembled using a socket flange, radially sealed with an O-ring, and then radially secured with fasteners, allowing for convenient and quick assembly and disassembly. For details, see [link to details]. Figure 1 The first arterial segment 210 has a first connecting flange 211 at one end facing the second arterial segment 220, and the second arterial segment 220 has a second connecting flange 222 at one end facing the first arterial segment 210. After the first arterial segment 210 and the second arterial segment 220 are connected by a socket joint, fasteners pass through the first connecting flange 211 and the second connecting flange 222 to lock and fix the first arterial segment 210 and the second arterial segment 220. Bolts and nuts are preferably used as fasteners.

[0082] Thus, when it is necessary to disassemble and replace the impeller 420 and the outlet chamber in the duct pump model 400, the bolts and nuts between the first arterial section 210 and the second arterial section 220 are removed, and the first arterial section 210 is pulled apart from the second arterial section 220, which also separates the pipe section 410 and the shaft cover 440. During this process, the first arterial section 210 moves the fixed section 411 and the detachable section 412 together, while the impeller 420, the shaft cover 440, and the rotating shaft 430 remain stationary along with the second arterial section 220. After the duct pump model 400 is disassembled, the user only needs to unscrew the detachable section 412 and the impeller 420 for replacement to change the structure of the outlet chamber and impeller 420 in the duct pump model 400. This allows for testing of the performance of duct pumps with different impeller 420 and outlet chamber structure designs. After replacement, the first arterial section 210 is inserted into the second arterial section 220 and the connection is locked by bolts and nuts, which can realize the connection and fixation between the detachable section 412 and the shaft cover 440. The disassembly and assembly are convenient, providing a low-cost and easy-to-operate solution for duct pump performance research.

[0083] Preferably, the first arterial segment 210 is made of a transparent material so that the user can observe the rotation of the impeller 420 in the catheter pump model 400.

[0084] See Figures 4 to 6 This application also provides an in vitro amplification testing system suitable for in vitro amplification testing of the catheter pump model 400 provided in any of the above embodiments. The system includes a simulated ventricle 100, a simulated artery 200, and a simulated tubing 300. The simulated ventricle 100 is connected to the simulated artery 200 via a partition 110 and to the simulated tubing 300 via a first interface 121. Preferably, the simulated artery 200 is the type provided in any of the above embodiments.

[0085] Because the external amplification test circuit is relatively large, in order to facilitate the movement of the first arterial segment 210, the external amplification test system in this embodiment also includes a truss assembly 910. The simulated ventricle 100, simulated artery 200 and simulated tubing 300 are all built and fixed on the truss assembly 910 to ensure the coaxiality of the external amplification test circuit and to address issues of disassembly, assembly and placement. With the aid of a guide rail slider assembly, easy disassembly and assembly between the first arterial segment 210 and the second arterial segment 220 can be achieved, thereby enabling the rapid disassembly and replacement of the impeller 420 and the outflow chamber.

[0086] For example, a guide rail slider assembly is disposed between the first arterial segment 210 and the truss assembly 910, including a guide rail 920 and a slider 930. One of the guide rail 920 and the slider 930 is fixed to the first arterial segment 210, and the other of the guide rail 920 and the slider 930 is fixed to the truss assembly 910. The guide rail 920 and the slider 930 slide to achieve relative sliding between the first arterial segment 210 and the truss assembly 910.

[0087] Or see Figure 5 The guide rail and slider assembly can also be disposed between the simulated ventricle 100 and the truss assembly 910, including a guide rail 920 and a slider 930. One of the guide rail 920 and the slider 930 is fixed to the simulated ventricle 100, and the other of the guide rail 920 and the slider 930 is fixed to the truss assembly 910. The guide rail 920 and the slider 930 slide together to realize relative sliding between the simulated ventricle 100 and the truss assembly 910, thereby driving the first arterial segment 210 to move.

[0088] Specifically, see Figure 4 and Figure 6 The simulated artery 200 further includes a third arterial segment 230, which connects to the second arterial segment 220 and the simulated conduit 300. The simulated ventricle 100 and the third arterial segment 230 are equipped with pressure sensors 801. The simulated ventricle 100 has a third perforation 133 through which the pressure sensor 801 can pass into the ventricular cavity. Similarly, the third arterial segment 230 can also have a corresponding opening for the pressure sensor 801 to pass through. The simulated conduit 300 is equipped with a flow sensor 802 and a throttle valve 803. By adjusting the throttle valve 803, the entire external amplification test circuit can be subjected to different afterload states. The two pressure sensors 801 and the flow sensor 802 are connected to a data acquisition instrument 804 to acquire real-time pressure and flow data, thereby obtaining performance curves of the duct pump model 400 under different afterloads. This is beneficial for users to evaluate the performance of duct pumps with different impeller structures 420 and outflow chambers under different afterloads.

[0089] Furthermore, the external amplification testing system also includes a fluid supply device 500 for infusing fluid into the simulated ventricle 100 and the second arterial segment 220. The fluid supply device 500 includes a reservoir 510 connected to a supply line 520, which is divided into two branches connecting to the simulated ventricle 100 and the second arterial segment 220 respectively. The simulated ventricle 100 has a second interface 122 through which the supply line 520 connects to the ventricular cavity.

[0090] 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 simulated ventricle 100 and the second arterial segment 220. The shunt lines 540, the simulated ventricle 100, and the second arterial segment 220 are connected by an externally threaded pagoda connector. Preferably, the second interface 122 on the simulated ventricle 100 is located below the simulated ventricle 100, and this second interface 122 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.

[0091] Furthermore, see Figures 4 to 6 The external amplification testing system also includes a gas supply device 600, which works in conjunction with a fluid supply device 500 to inject and discharge fluid within the external amplification testing circuit. In this embodiment, both the simulated ventricle 100 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 100 has a fifth interface 125, and the trachea 610 is connected to this fifth interface 125 to achieve communication with the ventricular cavity.

[0092] 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 simulated ventricle 100 and simulated artery 200 simultaneously through the diversion 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 100 to disassemble and replace the outflow chamber structure and impeller 420 in the catheter pump model 400. When the next test begins, reopen the three-way ball valve 530 to connect the air valve 620 to the atmosphere.

[0093] 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 pipeline 710, and a second thermostatic pipeline 720. The simulated ventricle 100 has a first perforation 131 and a second perforation 132. The thermometer is inserted into the simulated ventricle 100 through the first perforation 181 via a cable sealing device to measure the temperature of the liquid inside the simulated ventricle 100. The thermocouple is also inserted into the simulated ventricle 100 through the second perforation 182 using the same sealing method to heat the fluid inside the simulated ventricle 100. The first thermostatic pipeline 710 and the second thermostatic pipeline 720 connect the simulated ventricle 100 and the cooling plate. Specifically, the simulated ventricle 100 has a third interface 123 and a fourth interface 124. The first thermostatic pipeline 710 is connected to the third interface 123 to allow liquid in the simulated ventricle 100 to flow to the cooling plate, which cools the liquid. The second thermostatic pipeline 720 is connected to the fourth interface 124 to allow the cooled liquid to flow back to the simulated ventricle 100 via the second thermostatic pipeline 720. An external water pump is connected to the second thermostatic pipeline 720 to actively extract and pump back liquid from the simulated ventricle 100. Specifically, the temperature control system 700 also includes a temperature control mainboard for controlling the cooling plate for cooling or the thermocouple for heating.

[0094] 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 420 and outflow chamber structure, and the liquid loading and unloading in the external amplification testing circuit is also relatively convenient and simple.

[0095] At the start of the experiment, the impeller 420 to be tested and the detachable section 412 corresponding to the outflow chamber structure to be tested were installed: the bolts and nuts between the first arterial section 210 and the second arterial section 220 were removed, and the simulated ventricle 100 was slid to move the first arterial section 210 and other components fixed thereto away from the second arterial section 220. The impeller 420 to be tested and the detachable section 412 were then screwed onto the rotating shaft 430 and the fixed section 411, respectively. After installation, the simulated ventricle 100 was slid to move the first arterial section 210 and other components fixed thereto toward the second arterial section 220, and the bolts and nuts between the first arterial section 210 and the second arterial section 220 were installed, so that the external amplification test circuit returned to a sealed state.

[0096] 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 simultaneously inject liquid into the simulated ventricle 100 and the second arterial segment 220 using the liquid level difference. After the liquid is fully filled, close the gas valve 620 and the three-way ball valve 530 to make the external amplification test circuit sealed.

[0097] 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.

[0098] 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 430 with the speed controller and coupling to drive the rotating shaft 430 to rotate.

[0099] After completing the above operations, the impeller 420 rotates, pumping the fluid in the ventricular cavity out through the outlet window 4121 via the tube segment 410. The fluid flows from the first arterial segment 210 to the subsequent simulated tubing 300 and back into the simulated ventricle 100. 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 air valve 620 is opened to allow high-pressure gas. The air 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 air valve 620 are closed. If there are other models 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.

[0100] 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.

[0101] 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 duct pump model, characterized in that, include: Pipe sections, impellers, and power systems; The pipe section has an outlet window on its side wall, and the impeller passes through the pipe section and is located at the outlet window; the power system includes a shaft, the impeller is mounted on the shaft, and the shaft is detachably inserted into the pipe section; The operation of the power system drives the shaft to rotate, which in turn drives the impeller to rotate, suitable for pumping the fluid in the pipe section out through the outlet window.

2. The duct pump model according to claim 1, characterized in that, The rotating shaft is fitted with a shaft cover, which is adapted to be inserted into the pipe section and connected to the pipe section.

3. The duct pump model according to claim 1 or 2, characterized in that, The pipe section includes a fixed section and a detachable section. The detachable section is detachably installed on the fixed section, and the outlet window is provided on the side wall of the detachable section away from the fixed section. The fixed section is provided with a connecting part at the end away from the detachable section for connecting with external components.

4. The duct pump model according to claim 3, characterized in that, The fixed section and the detachable section are connected by a threaded connection. and / or The impeller and the shaft are connected by a threaded connection.

5. The duct pump model according to claim 1 or 2, characterized in that, The power system also includes a motor, a coupling, and a speed regulator. The motor has a power output shaft, the coupling connects the power output shaft and the rotating shaft, and the speed regulator is used to adjust the rotational speed of the power output shaft.

6. A simulated artery, characterized in that, Suitable for insertion into a duct pump model as described in any one of claims 1-5, comprising: First arterial segment and second arterial segment; The first arterial segment is adapted to dock with a simulated ventricle, and the second arterial segment is provided with a through-passage, which extends from the second arterial segment to the first arterial segment and is adapted for the shaft to pass through. The pipe segment is fixedly installed on the first arterial segment, the rotating shaft is located on the second arterial segment, and the first arterial segment and the second arterial segment are detachably connected; when the first arterial segment and the second arterial segment are separated, the pipe segment follows the first arterial segment, and the rotating shaft and the impeller follow the second arterial segment.

7. The simulated artery according to claim 6, characterized in that, The rotating shaft is fitted with a shaft cover, and the shaft cover is threadedly connected to the end of the through-channel facing the first arterial segment.

8. The simulated artery according to claim 6 or 7, characterized in that, The first arterial segment has a first connecting flange at one end facing the second arterial segment, and the second arterial segment has a second connecting flange at one end facing the first arterial segment. Fasteners are adapted to pass through the first connecting flange and the second connecting flange to fix the first arterial segment and the second arterial segment together.

9. An external amplification testing system, characterized in that, Suitable for in vitro scale-up testing of the catheter pump model as described in any one of claims 1-5, comprising: Truss assembly and simulated ventricles, simulated arteries and simulated tubing disposed on the truss assembly; The simulated ventricle, simulated artery, and simulated tubing are connected end to end to form a loop, and the simulated artery is the simulated artery as described in any one of claims 6-8.

10. The external amplification testing system according to claim 9, characterized in that, A guide rail slider assembly is provided between the simulated ventricle and the truss assembly; The guide rail and slider assembly includes a guide rail and a slider, and one of the guide rail and the slider is fixed to the simulated ventricle, while the other of the guide rail and the slider is fixed to the truss assembly. The guide rail and the slider slide together to achieve relative sliding between the simulated ventricle and the truss assembly, and the simulated ventricle is adapted to drive the first arterial segment to move.

11. The external amplification testing system according to claim 9 or 10, characterized in that, A partition is provided between the simulated ventricle and the first arterial segment, and the partition connects the simulated ventricle and the first arterial segment and is used to simulate an arterial valve; and, The end of the tube segment away from the rotating shaft is connected to the side of the diaphragm facing the simulated ventricle.

12. The external amplification testing system according to claim 9 or 10, characterized in that, The simulated artery also includes a third arterial segment, which connects the second arterial segment and the simulated tubing; and the simulated ventricle and the third arterial segment are equipped with pressure sensors, and the simulated tubing is equipped with a flow sensor and a throttle valve.

13. The external amplification testing system according to claim 9 or 10, characterized in that, Also includes: Fluid supply equipment; 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 branch pipelines, which are respectively connected to the simulated ventricle and the second arterial segment.

14. The external amplification testing system according to claim 13, characterized in that, Also includes: Gas supply equipment; The simulated ventricle and the second arterial segment are connected by a trachea, which is adapted to connect to the gas supply device to deliver high-pressure gas to the simulated ventricle and the simulated arterial, 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.