Testing device and testing method for a hydrocephalus shunt valve

Abstract

A testing device and testing method of a hydrocephalus shunt valve. It relates to the technical field of medical device testing. The long-term reliability and adaptability of the shunt valve can be simulated in a complex physiological environment. The testing device of the hydrocephalus shunt valve comprises a controller, a body position simulation device, an ICP pressure chamber, an IPP pressure chamber, a backflow pump, a flow sensor and a circulating pipeline. The body position simulation device comprises a support, a pair of long arms simulating the human torso and a pair of short arms simulating the human head and neck, and a motor one driving the pair of long arms to swing and a motor two driving the pair of short arms to swing. The present application combines the in-vitro hardware testing platform with different patient physiological models, can reproduce physiological characteristics such as basic body position posture change, body temperature circadian rhythm fluctuation and long-term applicability, and realizes the in-vitro testing of the shunt valve quickly, at low cost and with high authenticity. The present application can quantify the performance of the shunt valve in a real physiological environment.

Description

Technical Field

[0001] This invention relates to the field of medical device testing technology, and in particular to a testing device and method for performance evaluation and research and development verification of shunt valves used in the treatment of hydrocephalus. Background Technology

[0002] Hydrocephalus is a disease caused by obstruction of the pathway for cerebrospinal fluid (CSF) production in the ventricular system and its absorption through systemic circulation, leading to the active expansion of the ventricular system. In the short term, it can cause increased intracranial pressure (ICP) and brain parenchymal deformation; in the long term, it can lead to brain tissue degeneration. Symptoms include headache, dementia, gait disturbances, and urinary incontinence. Currently, the main treatment is ventriculoperitoneal shunt surgery, which involves implanting a shunt system (valve) to drain CSF from the ventricles to distal sites such as the peritoneum, maintaining stable intracranial pressure. However, the long-term reliability and compatibility of the shunt valve remain clinical challenges. Since the application of this technology, the failure rate of shunt valves remains too high, with major failure modes including over-drainage, under-drainage, shunt valve blockage, and implantation site infection.

[0003] First, overdrainage is one of the most common complications of shunt valves, especially when patients change from a supine to an upright position. The main reason is the gravitational siphon effect caused by positional changes: when a patient is upright, the shunt from the ventricle to the peritoneum forms a vertical column of fluid, generating additional negative pressure, causing the cerebrospinal fluid drainage rate to exceed physiological needs, resulting in an excessive decrease in intracranial pressure. Although modern shunt valves integrate anti-siphon devices or gravity compensation units, individual differences (such as peritoneal absorption capacity and venous pressure fluctuations) still make it difficult for some patients to completely avoid overdrainage.

[0004] Secondly, inadequate drainage manifests as a lower-than-expected cerebrospinal fluid (CSF) output, leading to persistently elevated intracranial pressure and failure or recurrence of hydrocephalus symptoms. Common causes include excessively high shunt valve pressure settings, valve adjustment drift, improper proximal catheter placement (the ventricular catheter tip being wrapped by the choroid plexus or adhering to the wall), and increased valve resistance due to elevated CSF protein levels. If inadequate drainage is not detected promptly, it can lead to visual impairment, cognitive decline, and even life-threatening acute intracranial pressure elevation.

[0005] Meanwhile, shunt valve occlusion is the most common cause of shunt failure. Occlusion can occur proximally (ventricular segment), at the valve, or distally (peritoneal segment). Proximally, occlusion is often caused by brain debris, choroid plexus tissue, blood clots, or glial proliferation encasing the duct opening; valve occlusion is frequently associated with fibrin deposition in high-protein cerebrospinal fluid; distal occlusion is often seen in the peritoneal segment due to omentum encapsulation, cyst formation, or poor peritoneal absorption. Some occlusions can be intermittent and related to body position or ventricular size, making diagnosis more difficult. Occlusion often requires surgical revision or replacement of the shunt valve, increasing the risk of multiple surgeries for the patient.

[0006] To address common clinical issues such as over-drainage, under-drainage, and shunt valve blockage, physical samples must be fabricated and systematically validated in vitro after the shunt valve design is completed. This requires an in vitro testing platform to evaluate shunt valve performance, including hydrodynamic characteristics, anti-siphon effect, pressure regulation accuracy, durability, anti-clogging capability, and hydrodynamic characteristics under various specific physiological conditions (including performance under dynamic conditions). Through iterative design optimization via sample testing, the long-term reliability and clinical suitability of the shunt valve can be significantly improved, reducing the need for re-operative revisions for patients and ultimately providing a safer solution for hydrocephalus treatment.

[0007] However, existing testing methods still have significant limitations, which can be summarized in the following three points:

[0008] Limitations of in vitro testing: Traditional in vitro testing (its basic principle: the test medium is drawn from a storage tank through a constant flow pump or syringe pump, flows through a pressure measuring device to obtain the pressure value, and is then injected into a diverter valve. The test medium from the diverter valve is then introduced into a flow measuring device via a catheter, the diverted flow rate is measured, and then it flows back into the storage tank) can only analyze the steady-state hydrodynamic characteristics of the diverter valve (such as pressure-flow characteristics, opening pressure, flow resistance, etc.). In actual clinical practice, drainage reduces the average ICP and changes the amplitude of ICP pulsation; traditional testing cannot reproduce this dynamic interaction. Furthermore, it can only simulate static positions (such as supine position) and cannot reproduce real-world scenarios such as standing, positional changes (such as moving from supine to sitting position within 5 seconds), and daily activities (such as coughing or walking).

[0009] Limitations of in vivo testing: In vivo testing primarily uses animal models (such as pigs and monkeys) to observe the long-term effectiveness and safety of shunt valves and obtain performance data under real physiological conditions. However, animal experiments involve ethical controversies, and are time-consuming and costly, making them unsuitable for extensive parameter iteration testing in the early stages of research and development. Clinical testing, on the other hand, is affected by individual patient differences, resulting in poor data repeatability and an inability to actively simulate pathological states.

[0010] Limitations of pure simulation testing: While full computer simulation is fast and low-cost, it requires precise knowledge of the physical characteristics of the flow divider valve (such as valve opening pressure and conduit flow resistance), and cannot verify the manufacturing deviations and long-term wear of the actual hardware (the impact on performance). It cannot verify the actual performance of the hardware, making it difficult to support hardware development.

[0011] Therefore, there is an urgent need in this field to develop a testing device and method for hydrocephalus shunt valves, in order to reproduce the dynamic interaction between patients and shunt valves under actual physiological conditions, and to provide a highly realistic, repeatable, and individualized testing platform for the research and evaluation of shunt systems (valve). Summary of the Invention

[0012] To address the aforementioned problems, this invention provides a testing device and method for a hydrocephalus shunt valve that can simulate complex physiological environments, test the long-term reliability and adaptability of the shunt valve, and repeatedly test it on different individuals.

[0013] The present invention provides a testing device for a hydrocephalus shunt valve, comprising a controller, a body position simulation device, an ICP pressure chamber, an IPP pressure chamber, a reflux pump, a flow sensor, and a circulation pipeline.

[0014] The body position simulation device includes a support frame, a pair of long arms simulating the human torso and a pair of short arms simulating the human head and neck, as well as a motor 1 that drives the pair of long arms to swing and a motor 2 that drives the pair of short arms to swing.

[0015] The ICP pressure chamber is connected to the pair of short arms via a vertical holding connection mechanism, and the IPP pressure chamber is connected to the pair of long arms via a vertical holding connection mechanism. When the pair of short arms and the pair of long arms swing, the ICP pressure chamber and the IPP pressure chamber always maintain an attitude perpendicular to the horizontal plane.

[0016] The circulation pipeline includes a pipe 1 for connecting the reflux pump and the ICP pressure chamber, a pipe 2 for connecting the ICP pressure chamber and the flow sensor, a pipe 3 for connecting the flow sensor and the IPP pressure chamber, and a pipe 4 for connecting the IPP pressure chamber and the reflux pump; a test piece mounting box is provided between the liquid outlet of the ICP pressure chamber and the pipe 2.

[0017] The ICP pressure chamber, IPP pressure chamber, reflux pump, flow sensor, motor one, and motor two are respectively connected to the controller;

[0018] Furthermore, in the body position simulation device, a pair of long arms includes a lower long arm and an upper long arm, a pair of short arms includes a lower short arm and an upper short arm, and the support also includes a connecting frame;

[0019] The bracket is provided with a motor mounting base, and the connecting frame is provided with a pin hole one and a pin hole two.

[0020] The lower long arm is provided with a motor connection hole biased towards the proximal end, and the proximal end of the lower long arm is provided with a hinge hole.

[0021] The upper long arm is provided with a hinge hole two that is biased towards the proximal end, and the proximal end of the upper long arm is provided with a motor mounting base two;

[0022] A hinge hole three is provided at the proximal end of the lower short arm, and a motor connection hole two is provided at the proximal end of the upper short arm.

[0023] The motor is mounted on the motor mounting base. After the motor shaft of the motor extends out of the motor mounting base, it is connected to the lower long arm through the motor connecting hole.

[0024] The second motor is mounted on the second motor mounting base. After the motor shaft of the second motor extends out of the second motor mounting base, it is connected to the upper short arm through the second motor connecting hole.

[0025] The hinge hole one of the lower long arm and the hinge hole three of the lower short arm are connected by a hinge pin.

[0026] Furthermore, the vertical holding connection mechanism includes: a pivot hole one and a pivot hole two are provided on the back side of the housings of the ICP pressure chamber and the IPP pressure chamber; pivot pins are provided on the pair of long arms and the pair of short arms respectively; the two pivot pins on the pair of long arms are connected from the front to the two pivot holes on the back side of the housing of the IPP pressure chamber; and the two pivot pins on the pair of short arms are connected from the back to the two pivot holes on the back side of the housing of the ICP pressure chamber.

[0027] Furthermore, the distance between the vertical lines of the first pivot hole and the second pivot hole is equal to the center distance of the pair of long arms or the pair of short arms after they are joined together.

[0028] Furthermore, the distance between the vertical lines of pin hole one and pin hole two on the connecting frame is equal to the center distance of the pair of long arms or the pair of short arms after they are joined together.

[0029] Furthermore, the ICP pressure chamber and the IPP pressure chamber have the same structure, each including a shell, a reservoir, a pressure regulating device, a pressure sensor, and a piston reciprocating drive mechanism. The pressure sensor and the piston reciprocating drive mechanism are connected to the controller. The reservoir contains a test medium simulating cerebrospinal fluid, and the pressure regulating device is connected to the reservoir.

[0030] Furthermore, the pressure regulating device includes a linear telescopic power source, a piston, a cylinder, and a mounting bracket. The mounting bracket is disposed on the inner wall of the housing, and the linear telescopic power source is mounted on the mounting bracket. The piston is connected to the top surface of the linear telescopic power source, and a matching cylinder is fitted onto the piston.

[0031] Furthermore, a pipeline water bath device is also provided on the second pipe, and the pipeline water bath device is installed on the upper long arm;

[0032] The test component mounting box is also equipped with a test component water bath device, which is located on the side of the liquid storage tank on the side of the ICP pressure chamber, or on the top surface of the upper short arm.

[0033] Furthermore, the pair of long and short arms are provided with graduations.

[0034] The present invention discloses a testing method for a hydrocephalus shunt valve testing device, comprising the following steps:

[0035] S1. Individualized parameter configuration: Based on the individual data of the test subject, adjust the parameters of the centralized parameter model in the simulation module, such as the beam lengths L1 and L2, and determine the input parameters for the specific test scenario.

[0036] S 2. Initialization of the test device: Install the cerebrospinal fluid diversion valve to be tested in the test component installation box, connect the ICP pressure chamber and the IPP pressure chamber, and adjust the test medium temperature to 37±1°C;

[0037] S3. Closed-loop test operation: Start the real-time control system. The simulation module outputs ICP setpoint, IPP setpoint, and body position angle setpoint according to the test scenario. The control unit receives the setpoint and the measured value transmitted by the data acquisition unit and adjusts the motor in the chamber and the body position adjustment motor through the PID controller to make the measured value track the setpoint. The data acquisition unit collects pressure data, angle data, and drainage rate data and stores them in the database.

[0038] S 4, Test Scenario Execution:

[0039] S 4.1, Diversion Test Scenario: In the horizontal position, the ICP and IPP reservoir chambers and the diversion valve are all on the same horizontal plane; then the pressure in the ICP increases at a constant rate from 0 mmHg to 30 mmHg, and then decreases at a constant rate from 30 mmHg back to 0 mmHg; the pressure in the IPP is maintained at a physiological value of 1.8 mmHg, consistent with the supine position; in the vertical position, the angles α1 and α2 are 90°, at which point the ICP pressure chamber and the diversion valve are directly above the IPP pressure chamber, and the pressure in the IPP is set to 16.7 mmHg, while the pressure change in the ICP is consistent with that in the horizontal position;

[0040] Or S 4.2, Postural change test scenario: Simulate the patient changing from supine to sitting position within 5 seconds and then back to supine position, maintaining each position for 1 hour, and record the mean ICP value, pulsation amplitude and shunt flow rate Q under steady state;

[0041] Or S 4.3, 24-hour daily activity scenario: Based on the patient's daily activity records, configure body position, pressure changes in IPP and ICP, continuous action for 24 hours, and record pressure and flow changes after simulating implantation of the shunt valve;

[0042] Or S 4.4, Durability and Contamination / Clogging Scenarios: Repeated tests were conducted over a three-month period, including an assessment of changes in flow and pressure performance. The tests included: continuous measurements for 28 days, pressure and flow rate changes measured at different ICP and IPP pressure parameter settings and at different temperatures, in both horizontal and vertical positions, iterative testing of the diverter valve, and analysis of particle accumulation under a microscope or high-speed camera.

[0043] S5. Data Processing and Analysis: After collecting data, calculate the mean ± standard deviation; compare the performance indicators of the flow divider valve in different scenarios to evaluate its applicability.

[0044] This invention combines an in vitro hardware testing platform with different patient physiological models to reproduce physiological characteristics such as basic postural changes, diurnal temperature fluctuations, and long-term applicability, enabling rapid, low-cost, and highly realistic in vitro testing of shunt valves. Methodologically, patient clinical data is used to identify model parameters. A closed-loop feedback system is constructed through a pressure interface, a postural simulation mechanism, and a flow monitoring module to simulate scenarios such as intracranial pressure modulation, postural changes, and 24-hour daily activities. This invention can test the pressure-flow characteristics of shunt valves and the phenomenon of excessive drainage related to postural changes, quantifying the performance of shunt valves under real physiological conditions. This provides testing support for the development of intelligent shunt devices while reducing the need for in vivo experiments. This invention is applicable to the research, development, performance evaluation, and certification stages of hydrocephalus shunt valves, offering advantages of high flexibility, repeatability, and individualization. Attached Figure Description

[0045] Figure 1 This is a three-dimensional illustration of the supine posture of the present invention. Figure 1 ;

[0046] Figure 2 This is a three-dimensional illustration of the supine posture of the present invention. Figure 2 ;

[0047] Figure 3 This is a three-dimensional illustration of the upright posture of the present invention. Figure 1 ;

[0048] Figure 4 This is a three-dimensional illustration of the upright posture of the present invention. Figure 2 ,

[0049] Figure 5 yes Figure 1 Enlarged view of part A in the middle;

[0050] Figure 6 This is a three-dimensional schematic diagram of the supine posture of the body position simulation device in this invention;

[0051] Figure 7 The three-dimensional explosion of the body position simulation device in this invention Figure 1 ;

[0052] Figure 8 The three-dimensional explosion of the body position simulation device in this invention Figure 2 ;

[0053] Figure 9 This is a three-dimensional schematic diagram of the upright posture of the body position simulation device in this invention. Figure 1 ;

[0054] Figure 10 This is a three-dimensional schematic diagram of the upright posture of the body position simulation device in this invention. Figure 2 ;

[0055] Figure 11 This is a schematic diagram of the action process structure of the body position simulation device in this invention. Figure 1 ;

[0056] Figure 12 This is a schematic diagram of the action process structure of the body position simulation device in this invention. Figure 2 ;

[0057] Figure 13 This is a schematic diagram of the action process structure of the body position simulation device in this invention. Figure 3 ;

[0058] Figure 14 This is a three-dimensional exploded view of the ICP pressure chamber in this invention;

[0059] Figure 15 This is a three-dimensional structural diagram of the liquid storage tank in the ICP pressure chamber of this invention;

[0060] Figure 16 This is a three-dimensional schematic diagram of the ICP pressure chamber shell in this invention;

[0061] Figure 17 This is an exploded view of the internal structure of the ICP pressure chamber in this invention;

[0062] Figure 18 This is a three-dimensional exploded view of the IPP pressure chamber in this invention;

[0063] Figure 19 This is a three-dimensional exploded view of the upper long arm in this invention;

[0064] Figure 20 This is a schematic diagram of the connection relationship of the test medium flow pipeline in this invention;

[0065] Figure 21 This is a schematic diagram of the working principle of the present invention;

[0066] Figure 22 The principle of body posture change in this invention Figure 1 ;

[0067] Figure 23The principle of body posture change in this invention Figure 2 ;

[0068] Figure 24 The principle of body posture change in this invention Figure 3 ;

[0069] Figure 25 This is a diagram illustrating the control strategy mechanism of the present invention;

[0070] Figure 26 This is a test flowchart of the present invention.

[0071] In the diagram, 1 is the bracket, 101 is the connecting bracket, 1011 is pin hole one, 1012 is pin hole two, 102 is motor one, 1021 is motor one mounting base, and 103 is motor two.

[0072] 11 is the lower long arm, 111 is hinge hole one, and 112 is motor connection hole one.

[0073] 12 is the upper long arm, 121 is the second motor mounting base, 122 is the second hinge hole, 123 is the pivot shaft mounting block, and 124 is the locking block.

[0074] 13 is the lower short arm, and 131 is the third hinge hole.

[0075] 14 is the upper short arm, and 141 is the second connection hole for the motor.

[0076] 2 is the ICP pressure chamber, 21 is the ICP pressure chamber housing, 211 is pivot hole one, 212 is pivot hole two, 22 is pressure sensor one, 23 is liquid reservoir one, 24 is pressure regulating device one, 241 is linear telescopic power source, 242 is piston, 243 is cylinder, and 244 is mounting bracket.

[0077] 3 is the test piece mounting box, 30 is the miniature diverter valve mounting box, and 31 is the test piece water bath device.

[0078] 4 is the flow sensor.

[0079] 5 is the IPP pressure chamber, 51 is the IPP pressure chamber housing, 52 is pressure sensor two, 53 is liquid storage tank two, and 54 is pressure regulating device two.

[0080] 6 is the reflux pump.

[0081] 7 is the pipeline water bath device.

[0082] 81 is pipe one, 82 is pipe two, 83 is pipe three, and 84 is pipe four.

[0083] Figure 22 This is the body position diagram when α1=α2=0°; Figure 23 This is the body position diagram when α2 > α1; Figure 24 This is a body position diagram when α1=α2=90°;

[0084] Figure 20 , 21 The center arrow indicates the direction of media flow. Detailed Implementation

[0085] The following is in conjunction with the appendix Figure 1-26 The technical solution of the present invention will be further illustrated through specific embodiments.

[0086] The accompanying drawings are for illustrative purposes only and are schematic diagrams, not actual images. They should not be construed as limiting the scope of this patent. To better illustrate the embodiments of the present invention, some parts in the drawings may be omitted, enlarged, or reduced, and do not represent the actual dimensions of the product. It is understandable to those skilled in the art that some well-known structures and their descriptions may be omitted in the drawings.

[0087] In the accompanying drawings of the embodiments of the present invention, the same or similar reference numerals correspond to the same or similar components. In the description of the present invention, it should be understood that if terms such as "upper," "lower," "left," "right," "inner," and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, they are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, the terms used to describe positional relationships in the drawings are only for illustrative purposes and should not be construed as limiting the present patent. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances.

[0088] In the description of this invention, unless otherwise explicitly specified and limited, the term "connection" or similar designation indicating a connection between components should be interpreted broadly. For example, it can refer to a fixed connection, a detachable connection, or an integral part; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can refer to the internal communication between two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0089] A testing device for a hydrocephalus shunt valve includes a controller, a body position simulation device, an ICP pressure chamber 2, an IPP pressure chamber 5, a reflux pump 6, a flow sensor 4, and circulation tubing.

[0090] The body position simulation device includes a support 1, a pair of long arms simulating the human torso and a pair of short arms simulating the human head and neck, as well as a motor 102 that drives the pair of long arms to swing and a motor 203 that drives the pair of short arms to swing.

[0091] ICP pressure chamber 2 is connected to a pair of short arms via a vertical holding connection mechanism, and IPP pressure chamber 5 is connected to a pair of long arms via a vertical holding connection mechanism. When the pair of short arms and the pair of long arms swing, they ensure that ICP pressure chamber 2 and IPP pressure chamber 5 always maintain a vertical orientation to the horizontal plane, so as to ensure that the liquid medium is not affected by the operating posture of the body position simulation device during the test, thus preventing pressure fluctuations.

[0092] The circulation pipeline includes pipe 81 for connecting the reflux pump 6 and the ICP pressure chamber 2, pipe 82 for connecting the ICP pressure chamber 2 and the flow sensor 4, pipe 83 for connecting the flow sensor 4 and the IPP pressure chamber 5, and pipe 84 for connecting the IPP pressure chamber 5 and the reflux pump 6; a test piece mounting box 3 is provided between the outlet of the ICP pressure chamber 2 and pipe 82; the outlet of the ICP pressure chamber 2 is the outlet of the storage tank 23.

[0093] The ICP pressure chamber 2, IPP pressure chamber 5, reflux pump 6, and flow sensor 4, as well as motor 102 and motor 2103, are respectively connected to the controller.

[0094] Furthermore, the body position simulation device includes a pair of long arms, a lower long arm 11 and an upper long arm 12, a pair of short arms, a lower short arm 13 and an upper short arm 14, and the support 1 also includes a connecting frame 101.

[0095] A motor mounting base 1021 is provided on the bracket 1, and a pin hole 1011 and a pin hole 1012 are provided on the connecting frame 101. The connecting frame 101 is fixedly connected to the bracket 1 using a U-shaped connecting structure, and the structure of the connecting frame 101 does not interfere with the reciprocating swing motion of each moving part. The distance between the vertical lines of pin hole 1011 and pin hole 1012 is the center distance of a pair of long arms or a pair of short arms combined.

[0096] A motor connection hole 112 biased towards the proximal end is provided on the lower long arm 11, and a hinge hole 111 is provided at the proximal end of the lower long arm 11.

[0097] The upper long arm 12 is provided with a hinge hole 122 biased towards the proximal end, and the proximal end of the upper long arm 12 is provided with a motor mounting base 121.

[0098] A hinge hole 131 is provided at the proximal end of the lower short arm 13, and a motor connection hole 141 is provided at the proximal end of the upper short arm 14.

[0099] Motor 102 is mounted on motor 1 mounting base 1021. After the motor shaft of motor 102 extends out of motor 1 mounting base 1021, it is connected to the lower long arm 11 through motor 1 connecting hole 112.

[0100] Motor 2 103 is mounted on motor 2 mounting base 121. After the motor shaft of motor 2 103 extends out of motor 2 mounting base 121, it is connected to the upper short arm 14 through motor 2 connecting hole 141.

[0101] The hinge hole 111 of the lower long arm 11 and the hinge hole 131 of the lower short arm 13 are connected by a hinge pin.

[0102] The human body models of different age groups in this invention can be simulated by the waist-shoulder distance L1 and the shoulder-external auditory canal distance L2, and different body postures can be simulated by the changes in angles α1 and α2 (such as standing, supine, etc.).

[0103] Furthermore, the vertical holding connection mechanism includes: a pivot hole 211 and a pivot hole 212 are provided on the back of the housings of the ICP pressure chamber 2 and the IPP pressure chamber 5; pivot shaft mounting blocks 123 are provided on a pair of long arms and a pair of short arms respectively; locking blocks 124 are provided at both ends of the pivot shaft mounting blocks 123; the two pivot shaft mounting blocks 123 on the pair of long arms are connected from the front to the two pivot holes on the back of the housing of the IPP pressure chamber; and the two pivot shaft mounting blocks 123 on the pair of short arms are connected from the back to the two pivot holes on the back of the housing of the ICP pressure chamber.

[0104] Furthermore, the distance between the vertical lines of pivot hole 1 211 and pivot hole 2 212 is equal to the center distance of a pair of long arms or a pair of short arms combined.

[0105] Furthermore, the distance between the vertical lines of pin hole 1011 and pin hole 1012 on the connecting frame 101 is equal to the center distance of a pair of long arms or a pair of short arms combined.

[0106] Furthermore, the ICP pressure chamber includes an ICP pressure chamber housing 21, a reservoir 23, a pressure regulating device 24, a pressure sensor 22, and a piston reciprocating drive mechanism. The pressure sensor 22 and the piston reciprocating drive mechanism are connected to a controller. The reservoir 23 contains a test medium simulating cerebrospinal fluid, and the pressure regulating device 24 is connected to the reservoir 23.

[0107] The IPP pressure chamber includes an IPP pressure chamber housing 51, a reservoir 53, a pressure regulating device 54, a pressure sensor 52, and a piston reciprocating drive mechanism. The pressure sensor 52 and the piston reciprocating drive mechanism are connected to a controller. The reservoir 53 contains a test medium simulating cerebrospinal fluid, and the pressure regulating device 54 is connected to the reservoir 53.

[0108] Furthermore, the pressure regulating device includes a linear telescopic power source 241, a piston 242, a cylinder 243, and a mounting bracket 244. The mounting bracket 244 is disposed on the inner wall of the housing. The linear telescopic power source 241 is mounted on the mounting bracket 244. The piston 242 is connected to the top surface of the linear telescopic power source 241. A matching cylinder 243 is fitted onto the piston 242.

[0109] The reservoir contains a test medium simulating cerebrospinal fluid. A linear telescopic power source 241 pushes a piston 242 within a cylinder 243 to adjust the pressure within the reservoir. This simulates changes in intracranial pressure and abdominal pressure changes depending on the patient's posture (lying down or standing). The diversion valve will then divert the flow according to different preset levels, allowing for testing of its performance. This invention employs a piston-type pressure regulation method driven by a motor and controlled by a closed loop. By applying different current signals to the actuator, the motor outputs different torques, which, after calculation, produce a linear thrust. This accurately generates controllable, reproducible, and quantifiable pressure waveforms, simulating the real physiological pressure environment of the human body. The simulation principle fits the physiological changes in intracranial and abdominal pressure into a complex composite pressure signal (including pulse waves, respiratory waves, etc.) of transient impacts and baseline pressure. The device of this invention, through programmed control of the motor current and movement sequence, can reproduce: static pressure differences caused by changes in body position (lying down, standing, etc.); low-frequency periodic pressure fluctuations caused by respiratory movements; and instantaneous pressure pulses generated by coughing, exertion, etc. It should be noted that the pressure waveform used in the device of this invention is based on existing publicly available physiological data and typical operating conditions. Although it cannot completely cover all individual differences, pathological states, and all subtle physiological activities, and it is somewhat simplified and approximated to the real complex physiological pressure environment in vivo (this is a limitation of in vitro experiments), it can still achieve the purpose of this invention.

[0110] Furthermore, a pipeline water bath device 7 is also provided on the second pipe 82, which is located on the upper long arm 12; to maintain the internal temperature of the test medium within 37±1°C, simulating a temperature close to that of the human body.

[0111] The test component mounting box 3 is also equipped with a test component water bath device 31, which is located on the side of the liquid storage tank 23 on the side of the ICP pressure chamber 2, or on the top surface of the upper short arm 14. The diverter valve and all the pipes from the diverter valve to the IPP pressure chamber 5 are enclosed in it to simulate the environmental conditions of the diverter valve and its pipes placed in the human body.

[0112] The main body of this invention consists of two ICP pressure chambers 2 simulating intracranial pressure and an IPP pressure chamber 5 simulating abdominal pressure, as well as a pair of long and short arms simulating changes in body posture. The body posture is represented when α2=α1=0. If the pressure inside the ICP is higher than the set value of the measured shunt valve, the measured shunt valve will open, and the experimental medium will flow from the valve through pipe 2 (82) into the flow sensor 4, and then through pipe 3 (83) into the IPP pressure chamber 5. The liquid in the IPP pressure chamber 5 can also flow back to the ICP pressure chamber 2 through pipe 4 (84), the return pump 6, and pipe 1 (81), forming a recirculating operating mechanism and avoiding the need for manual water injection and replacement during the experiment. Changing the relative height between the ICP and IPP chambers is mainly to simulate the change in hydrostatic pressure difference of cerebrospinal fluid caused by changes in body posture, thereby replicating the siphon effect of the hydrocephalus shunt valve under different body postures. The intracranial-peritoneal pressure difference caused by changes in body position is essentially a change in the hydrostatic pressure gradient due to gravity. Whether the diversion valve has anti-siphon capability is one of the key considerations in its design. Although intracranial and peritoneal pressures in real physiological environments are also affected by various dynamic factors such as respiratory movements, muscle contractions, vascular pulsation, and cerebrospinal fluid circulation dynamics, these complex dynamic pressure fluctuations cannot be fully reproduced solely by hydrostatic pressure difference. This is a reasonable and acceptable limitation of in vitro simulation experiments.

[0113] Due to continuous iterations in hydrocephalus shunt valves, clinically used shunt valves have developed into a diverse system to suit the different pathological needs of patients. Meanwhile, thanks to breakthroughs in precision manufacturing technology, miniaturization of shunt valves has become the mainstream development, with their overall size gradually reduced to the millimeter level. To address the experimental testing of miniature shunt valves, a dedicated miniature shunt valve mounting box 30 was designed. It can be placed inside the test piece mounting box 3.

[0114] Furthermore, the long and short arms are equipped with scales that can be adjusted according to the patient's body size data to suit different individualized testing needs.

[0115] The testing method for a hydrocephalus shunt valve testing device includes the following steps:

[0116] S1. Individualized parameter configuration: Based on the individual data of the test subject, such as intracranial pressure and cerebrospinal fluid outflow resistance in lumbar puncture test, adjust the parameters of the lumbar parameter model in the simulation module, such as the beam lengths L1 and L2 (i.e., the distance between the waist and shoulder L1 and the distance between the shoulder and the external auditory canal L2, which can be adjusted according to different human bodies) to determine the input parameters for specific test scenarios such as shunt characteristic test, body position change test, and 24-hour daily activity test.

[0117] S 2. Initialization of the test device: Install the cerebrospinal fluid diversion valve to be tested in the test component installation box 3, connect the ICP pressure chamber 2 and the IPP pressure chamber 5, inject deionized deaerated water into the storage chamber and water bath, and adjust the temperature of the test medium to 37±1°C.

[0118] S3. Closed-loop test operation: The real-time control system is started. The simulation module outputs ICP setpoints, IPP setpoints, and body position angle setpoints α1 and α2 according to the test scenario. The control unit receives the setpoints and the measured values ​​ICP, IPP, α1, α2, and Q transmitted by the data acquisition unit. It adjusts the motors in the chamber and the body position adjustment motor through the PID controller to make the measured values ​​track the setpoints. The data acquisition unit collects pressure data, angle data, and drainage rate data and stores them in the database. The controller in this case integrates the simulation module, the real-time control unit, and the data acquisition unit. The modules work together to set, adjust, and acquire test parameters. As this is a conventional technical measure in this field, it will not be described in detail here.

[0119] S 4, Test Scenario Execution:

[0120] S 4.1, Diversion Test Scenario: In the horizontal position, the ICP and IPP reservoir chambers and the diversion valve are all on the same horizontal plane; then the pressure in the ICP increases at a constant rate from 0 mmHg to 30 mmHg (lasting 2 minutes), and then decreases at a constant rate from 30 mmHg back to 0 mmHg (also lasting 2 minutes); the pressure in the IPP is maintained at a physiological value of 1.8 mmHg, consistent with the supine position; in the vertical position, angles α1 and α2 are 90°, at which point the ICP pressure chamber and the diversion valve are directly above the IPP pressure chamber, and the pressure in the IPP is set to 16.7 mmHg, while the pressure in the ICP changes in the same way as in the horizontal position; record the real-time ICP pressure value, IPP pressure value, diversion flow rate Q, and pressure-flow rate change curve at different pressure stages (pressure increase, pressure decrease) in both the horizontal and vertical positions. If the measured pressure-flow rate curve is inconsistent with the theoretical design curve of the diversion valve, it indicates that the diversion valve may have problems such as valve response delay and insufficient gravity adaptability, requiring optimization of the valve structure or resistance adjustment mechanism. This invention uses a host computer and a driver in the controller to output a constant-rate current signal, causing a motor to push a piston at a constant speed. This achieves a uniform change in the intracranial cavity volume, thereby causing the intracranial pressure to rise uniformly and linearly. This simulates the process of a slow increase in intracranial pressure, achieving linear incremental control of intracranial pressure through uniform drive. The aforementioned pressure values ​​of 1.8 mmHg in the supine position and 16.7 mmHg in the vertical position are empirical values ​​summarized in existing literature in this field.

[0121] Or S 4.2, Postural Change Test Scenario: Simulate a patient switching from a supine position (α1=α2=0°, IPP=1.8mmHg) to a sitting position (α1=α2=90°, IPP=16.7mmHg) within 5 seconds, and then returning to the supine position. Each position is maintained for 1 hour, and the mean ICP, pulsation amplitude, and shunt flow rate Q are recorded under steady state. If the mean ICP pressure, pulsation amplitude, and flow rate Q in the sitting position are inconsistent with the theoretically predicted range of postural adaptability, or if the parameter fluctuations during the switching process cannot quickly stabilize, it indicates that the shunt valve cannot effectively cope with sudden changes in postural position.

[0122] Or S 4.3, 24-hour daily activity scenario: Based on the patient's daily activity records such as supine, sitting, standing, and coughing, configure body position, IPP and ICP pressure changes, and continuously perform these actions for 24 hours. Record the real-time ICP pressure value, IPP pressure value, shunt flow rate Q, and statistical characteristics of each parameter after simulating shunt valve implantation (such as daily average ICP, peak flow rate, pressure peak amplitude and duration during coughing). If the average ICP pressure cannot be maintained within the physiological safety range within 24 hours, the flow rate fluctuation does not conform to the theoretical prediction of daily activities, or there is abnormal drainage during sudden pressure changes such as coughing (such as a sudden drop in flow rate leading to a sudden rise in ICP pressure, or a sudden rise in flow rate causing excessive drainage), it indicates that the shunt valve is not suitable for the patient's daily activities.

[0123] Or S 4.4, Durability and Contamination / Clogging Scenario: Repeated tests were conducted over a three-month period, including an assessment of changes in flow and pressure performance. The tests included: continuous measurements for 28 days, pressure and flow rate changes measured at different ICP and IPP pressure parameter settings and at different temperatures, in both horizontal and vertical positions. The diverter valve was tested iteratively, and particle accumulation was analyzed under a microscope or high-speed camera. If the pressure-flow curve shows significant drift within three months, the flow rate attenuation rate is not lower than the theoretical allowable threshold (e.g., <5%), or there is significant particle accumulation, it indicates that the diverter valve's durability and contamination resistance do not meet the requirements.

[0124] S5. Data Processing and Analysis: After collecting data, calculate the mean ± standard deviation; compare the performance indicators of the flow divider valve in different scenarios to evaluate its applicability.

[0125] It should be stated that the above-described specific embodiments are merely preferred embodiments of the present invention and the technical principles employed. Those skilled in the art should understand that various modifications, equivalent substitutions, and variations can be made to the present invention based on the technical content disclosed in this application. However, such variations, as long as they do not depart from the spirit of the present invention, should be within the protection scope of the present invention. Furthermore, some terminology used in this specification and claims is not limiting but merely for ease of description.

Claims

1. A testing device for a hydrocephalus shunt valve, comprising a controller, characterized in that, It also includes a body position simulation device, an ICP pressure chamber (2), an IPP pressure chamber (5), a reflux pump (6), a flow sensor (4), and circulation piping. The body position simulation device includes a support (1), a pair of long arms simulating the human torso and a pair of short arms simulating the human head and neck, as well as a motor one (102) that drives the pair of long arms to swing and a motor two (103) that drives the pair of short arms to swing. The ICP pressure chamber (2) is connected to the pair of short arms through a vertical holding connection mechanism, and the IPP pressure chamber (5) is connected to the pair of long arms through a vertical holding connection mechanism. When the pair of short arms and the pair of long arms swing, the ICP pressure chamber (2) and the IPP pressure chamber (5) always maintain an attitude perpendicular to the horizontal plane. The circulation pipeline includes a first pipe (81) for connecting the reflux pump (6) and the ICP pressure chamber (2), a second pipe (82) for connecting the ICP pressure chamber (2) and the flow sensor (4), a third pipe (83) for connecting the flow sensor (4) and the IPP pressure chamber (5), and a fourth pipe (84) for connecting the IPP pressure chamber (5) and the reflux pump (6); a test piece mounting box (3) is provided between the outlet of the ICP pressure chamber (2) and the second pipe (82); The ICP pressure chamber (2), IPP pressure chamber (5), reflux pump (6), and flow sensor (4), as well as motor one (102) and motor two (103) are respectively connected to the controller; The body position simulation device includes a pair of long arms, including a lower long arm (11) and an upper long arm (12), and a pair of short arms, including a lower short arm (13) and an upper short arm (14). The support (1) also includes a connecting frame (101). A motor mounting base (1021) is provided on the bracket (1), and a pin hole (1011) and a pin hole (1012) are provided on the connecting frame (101). The lower long arm (11) is provided with a motor connection hole (112) biased towards the proximal end, and the proximal end of the lower long arm (11) is provided with a hinge hole (111). The upper long arm (12) is provided with a hinge hole (122) biased towards the near end, and the near end of the upper long arm (12) is provided with a motor mounting seat (121). A hinge hole three (131) is provided at the proximal end of the lower short arm (13), and a motor connection hole two (141) is provided at the proximal end of the upper short arm (14). The motor (102) is mounted on the motor mounting base (1021). After the motor shaft of the motor (102) extends out of the motor mounting base (1021), it is connected to the lower long arm (11) through the motor connection hole (112). The second motor (103) is mounted on the second motor mounting base (121). After the motor shaft of the second motor (103) extends out of the second motor mounting base (121), it is connected to the upper short arm (14) through the second motor connecting hole (141). The hinge hole 1 (111) of the lower long arm (11) and the hinge hole 3 (131) of the lower short arm (13) are connected by a hinge pin. The vertical holding connection mechanism includes: a pivot hole one and a pivot hole two are provided on the back of the housings of the ICP pressure chamber (2) and the IPP pressure chamber (5); pivot shaft mounting blocks (123) are provided on the pair of long arms and the pair of short arms respectively; locking blocks (124) are provided at both ends of the pivot shaft mounting blocks (123); the two pivot shaft mounting blocks (123) on the pair of long arms are connected from the front to the two pivot holes on the back of the housing of the IPP pressure chamber; and the two pivot shaft mounting blocks (123) on the pair of short arms are connected from the back to the two pivot holes on the back of the housing of the ICP pressure chamber.

2. The testing device for a hydrocephalus shunt valve according to claim 1, characterized in that, The distance between the vertical lines of pivot hole one and pivot hole two is equal to the center distance of the pair of long arms or the pair of short arms when they are joined together.

3. The testing device for a hydrocephalus shunt valve according to claim 1, characterized in that, The distance between the vertical lines of pin hole one (1011) and pin hole two (1012) on the connecting frame (101) is equal to the center distance of the pair of long arms or the pair of short arms after they are joined together.

4. The testing device for a hydrocephalus shunt valve according to claim 1, characterized in that, The ICP pressure chamber and the IPP pressure chamber have the same structure, including an ICP pressure chamber shell (21), an IPP pressure chamber shell (51), a first reservoir (23), a second reservoir (53), a first pressure regulating device (24), a second pressure regulating device (54), a first pressure sensor (22), a second pressure sensor (52), and a piston reciprocating drive mechanism. The first pressure sensor (22), the second pressure sensor (52), and the piston reciprocating drive mechanism are connected to the controller. The first reservoir (23) and the second reservoir (53) contain a test medium that simulates cerebrospinal fluid. The first pressure regulating device (24) and the second pressure regulating device (54) are connected to the first reservoir (23) and the second reservoir (53).

5. The testing device for a hydrocephalus shunt valve according to claim 4, characterized in that, The pressure regulating device (24) includes a linear telescopic power source (241), a piston (242), a cylinder (243), and a mounting bracket (244). The mounting bracket (244) is disposed on the inner wall of the ICP pressure chamber housing (21). The linear telescopic power source (241) is mounted on the mounting bracket (244). The piston (242) is connected to the top surface of the linear telescopic power source (241). The cylinder (243) is fitted on the piston (242).

6. The testing device for a hydrocephalus shunt valve according to claim 1, characterized in that, A pipeline water bath device (7) is also provided on the second pipe (82), and the pipeline water bath device (7) is installed on the upper long arm (12); The test component mounting box (3) is also provided with a test component water bath device (31), which is located on the side of the liquid storage tank (23) on the side of the ICP pressure chamber (2), or on the top surface of the upper short arm (14).

7. The testing device for a hydrocephalus shunt valve according to claim 1, characterized in that, The pair of long and short arms are provided with graduations.

8. The testing method of the testing device for a hydrocephalus shunt valve as described in claim 1, characterized in that, Includes the following steps: S1. Individualized parameter configuration: Based on the individual data of the test subject, adjust the parameters of the centralized parameter model in the simulation module, such as the beam lengths L1 and L2, and determine the input parameters for the specific test scenario. S2. Initialization of the test device: Install the cerebrospinal fluid diversion valve to be tested in the test component installation box (3), connect the ICP pressure chamber (2) and the IPP pressure chamber (5), and adjust the test medium temperature to 37±1°C; S3. Closed-loop test operation: Start the real-time control system. The simulation module outputs ICP setpoint, IPP setpoint, and body position angle setpoint according to the test scenario. The control unit receives the setpoint and the measured value transmitted by the data acquisition unit and adjusts the motor in the chamber and the body position adjustment motor through the PID controller to make the measured value track the setpoint. The data acquisition unit collects pressure data, angle data, and drainage rate data and stores them in the database. S4. Test Scenario Execution: S4.1, Diversion Test Scenario: In the horizontal position, the ICP and IPP reservoir chambers and the diversion valve are all on the same horizontal plane; then the pressure in the ICP increases at a constant rate from 0 mmHg to 30 mmHg, and then decreases at a constant rate from 30 mmHg back to 0 mmHg; the pressure in the IPP is maintained at a physiological value of 1.8 mmHg, consistent with the supine position; for the vertical position, the angles α1 and α2 are 90°, at which point the ICP pressure chamber and the diversion valve are directly above the IPP pressure chamber, and the pressure in the IPP is set to 16.7 mmHg, while the pressure change in the ICP is consistent with that in the horizontal position; Or S4.2, Postural Change Test Scenario: Simulate the patient changing from a supine position to a sitting position within 5 seconds, and then returning to a supine position. Each position is maintained for 1 hour, and the mean ICP value, pulsation amplitude and shunt flow rate Q are recorded under steady state. Or S4.3, 24-hour daily activity scenario: Based on the patient's daily activity records, configure body position, pressure changes in IPP and ICP, continuous action for 24 hours, and record pressure and flow changes after simulating implantation of the shunt valve; Or S4.4, durability and contamination clogging scenario: Repeated tests were conducted over a three-month period, including an assessment of changes in flow and pressure performance. The tests included: continuous measurements for 28 days, pressure and flow rate changes measured at different ICP and IPP pressure parameter settings and at different temperatures, in horizontal and vertical positions, iterative testing of the diverter valve, and analysis of particle accumulation under a microscope or high-speed camera. S5. Data Processing and Analysis: After collecting data, calculate the mean ± standard deviation; compare the performance indicators of the flow divider valve in different scenarios to evaluate its applicability.

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