A test system for a breathing machine

Abstract

The utility model embodiment provides a kind of test system for breathing machine, by integrated initiative simulation lung, airway obstruction model and air leakage valve, has constructed a comprehensive test platform capable of simultaneously simulating normal breathing / central respiratory event, obstructive respiratory event and air leakage event.This comprehensive simulation capability solves the problem of single simulation of related technical equipment, avoids the cumbersome process of using multiple devices or multiple tests, greatly improves the efficiency of breathing machine test and the comprehensiveness of results.This makes the evaluation of APAP device performance closer to the clinical real scene, provides more reliable and efficient tools for new product development and performance verification.

Description

Technical Field

[0001] This utility model relates to the field of ventilator testing technology, and in particular to a testing system for ventilators. Background Technology

[0002] Ventilator testing is a crucial step in evaluating and validating ventilator performance, aiming to ensure that the device can safely and effectively treat patients. Traditional ventilator testing primarily focuses on basic parameters such as delivery pressure, flow rate, and alarm functions. However, with the increasing prevalence of intelligent devices such as automated external defibrillators (APAPs), the requirements for testing have become increasingly demanding. Modern ventilator testing not only needs to verify basic functions but, more importantly, assess its ability to recognize and respond to events in complex, dynamic respiratory events and disruptive scenarios. This type of testing typically requires specialized simulation equipment to reproduce various physiological and non-physiological conditions that patients may encounter, thereby comprehensively measuring the therapeutic efficacy and safety of the ventilator in actual use.

[0003] In practical applications, the relevant technologies can usually only simulate a single type of respiratory event or disturbance, resulting in significant deficiencies in simulating complex respiratory events and leading to low testing efficiency. Utility Model Content

[0004] This utility model provides a testing system for ventilators to overcome or at least partially solve the above-mentioned problems.

[0005] This utility model embodiment also discloses a testing system for a ventilator, the testing system comprising:

[0006] Simulated lungs used to simulate human respiratory movements;

[0007] Airway obstruction device used to simulate airway resistance;

[0008] A leak detector used to simulate gas leaks;

[0009] The airway obstruction device and the air leakage device are sequentially and fluidly connected between the simulated lung and the ventilator under test, and the airway obstruction device is connected between the simulated lung and the air leakage device.

[0010] Optionally, the leakage device includes a solenoid valve for controlling the flow of fluid in the pipeline, and a proportional valve for controlling the amount of leakage by different opening degrees, wherein the proportional valve is connected between the solenoid valve and the simulated lung.

[0011] Optionally, the testing system further includes a three-way connector, which is connected between the simulated lung and the ventilator under test via opposing first and second ports, and the third port of the three-way connector is connected to the solenoid valve and the proportional valve.

[0012] Optionally, the leakage device further includes a leakage component with a leakage hole, the leakage component being connected between the solenoid valve and the simulated lung or between the solenoid valve and the ventilator under test, the leakage component being a standard air resistance or a breathing mask worn on a head simulation model.

[0013] Optionally, the airway obstruction device includes a pressure tube and a flexible, deformable ventilation tube; the flexible tube is located inside the pressure tube, and a sealed space exists between the flexible tube and the pressure tube; the flexible tube is connected to the simulated lung.

[0014] The testing system also includes a pressure generator connected to the pressure tube for supplying gas pressure to the confined space to compress the flexible tube.

[0015] Optionally, the testing device further includes a pressure valve and a first vent valve, wherein the pressure valve and the first vent valve are sequentially connected between the pressure generator and the airway blocking device, and the first vent valve is connected between the pressure valve and the airway blocking device, wherein the pressure valve is used to control the flow of fluid in the pipeline between the pressure generator and the airway blocking device, and the first vent valve is used to control the airway blocking device to release pressure to the external environment.

[0016] Optionally, the testing device further includes a second vent valve, which is connected between the pressurizing valve and the pressure generator, for controlling the pressure generator to release pressure to the external environment.

[0017] Optionally, the testing system further includes a data acquisition device for monitoring pressure and / or flow changes in the tubing between the airway obstruction device and the ventilator under test.

[0018] Optionally, the data acquisition device includes a ventilator testing unit connected between the airway obstruction device and the leakage device; or,

[0019] The data acquisition device includes a first pressure gauge, a second pressure gauge, and a flow meter. The first pressure gauge is used to monitor the gas pressure received or exhaled by the ventilator under test. The second pressure gauge is used to monitor the pressure change of the airway obstruction device. The flow meter is used to monitor the inspiratory and expiratory flow rates of the ventilator under test.

[0020] Optionally, the testing system further includes a control device for controlling the operation of the simulated lung, the airway obstruction device, and the leakage device according to a set program to simulate respiratory events.

[0021] Optionally, the simulated lung includes a cylinder, and the control device is used to control the oscillation frequency of the cylinder to simulate snoring.

[0022] Optionally, one end of the pressure tube is provided with a first sealing member, and the other end of the pressure tube is provided with a second sealing member;

[0023] The pressure tube is sealed at both ends by the first sealing member and the second sealing member to form the sealed space.

[0024] Optionally, the first sealing member is provided with a first interface and a second interface;

[0025] The first interface is used to connect to one end of the flexible tube and the ventilator tester, respectively;

[0026] The second interface is used to connect to the pressure generator;

[0027] The second sealing member is provided with a third interface, which is used to connect to the other end of the latex tube and the simulated lung.

[0028] The embodiments of this utility model have the following advantages:

[0029] The testing device of this embodiment integrates an active simulated lung 101, an airway obstruction model 102, and a leak valve 103 to construct a comprehensive testing platform capable of simultaneously simulating normal / central respiratory events, obstructive respiratory events, and leak events. This comprehensive simulation capability solves the problem of related technologies and devices simulating only single or incomplete scenarios, avoiding the cumbersome process of using multiple devices or conducting multiple tests, and greatly improving the efficiency and comprehensiveness of ventilator testing results. This makes the evaluation of APAP device performance closer to real-world clinical scenarios, providing a more reliable and efficient tool for new product development and performance verification. Attached Figure Description

[0030] To more clearly illustrate the technical solutions of the embodiments of this utility model, the drawings used in the description of the embodiments of this utility model will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this utility model. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0031] Figure 1This is a first structural schematic diagram of a testing system provided in an embodiment of this application;

[0032] Figure 2 This is a schematic diagram of the second structure of a testing system provided in an embodiment of this application;

[0033] Figure 3 This is a schematic diagram of the structure of a leak-proof device provided in the embodiments of this application;

[0034] Figure 4 This is a schematic diagram of the structure of an airway obstruction device provided in the embodiments of this application;

[0035] Figure 5 This is a schematic diagram of the third structure of a testing system provided in the embodiments of this application;

[0036] Figure 6 This is a schematic diagram of the fourth structure of a testing system provided in the embodiments of this application;

[0037] Figure 7 This is a fifth structural schematic diagram of a testing system provided in the embodiments of this application. Detailed Implementation

[0038] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present utility model.

[0039] To make the above-mentioned objectives, features and advantages of this utility model more apparent and understandable, the utility model will be further described in detail below with reference to the accompanying drawings and specific embodiments.

[0040] To enable those skilled in the art to better understand the embodiments of this utility model, an example is used below to explain some of the technical terms involved in the embodiments of this utility model.

[0041] (1) Ventilator: A medical electrical device intended to automatically increase or provide ventilation to a patient’s lungs when connected to the patient’s airway.

[0042] (2) Automatic Continuous Positive Airway Pressure (Auto-CPAP, APAP): Under computer control, modern continuous positive airway pressure ventilators can automatically adjust the continuous positive airway pressure according to actual needs. APAP devices, or Automatic CPAP machines, are ventilators that automatically adjust the delivery pressure according to the patient's respiratory status. Unlike traditional continuous positive airway pressure (CPAP) devices, APAP devices continuously monitor airflow and automatically increase the treatment pressure to open the airway when a respiratory event (such as obstructive apnea) is detected. After the respiratory event is resolved, it lowers the pressure again to improve patient comfort.

[0043] (3) Continuous positive airway pressure (CPAP): a ventilation mode or sleep apnea treatment mode in which the patient continuously breathes at a set airway pressure level higher than the ambient pressure.

[0044] (4) Respiratory events: Abnormal breathing phenomena that occur during sleep and are interpreted by polysomnography. These include apnea, hypopnea, respiratory effort-related arousal, and snoring.

[0045] (5) Obstructive apnea: One type of apnea. It meets the criteria for apnea and involves a sustained or increased inspiratory effort throughout the entire period of airflow loss. "Inspiratory effort" refers to the muscle contractions or physical work performed by the patient or a simulated lung to overcome factors such as airway resistance and lung compliance during inhalation. Simply put, it is the "force of inhalation".

[0046] (6) Obstructive hypoventilation: One type of hypoventilation. It meets the criteria for hypoventilation and meets any of the following: ① Snoring is present during the duration of the event; ② Nasal pressure or non-invasive positive pressure ventilation airflow signal is flat compared with baseline breathing; ③ Paradoxical chest and abdominal movements occur during the duration of the event but are not present before the event.

[0047] (7) Central apnea: One type of apnea. It meets the criteria for apnea and there is no inspiratory effort during the entire period of airflow loss; the criteria for apnea in children must be met simultaneously for any of the following: ① The event lasts for ≥20 seconds; ② The event lasts for at least 2 baseline respiratory cycles and is accompanied by awakening or a decrease in oxygen saturation of ≥3%; ③ The event lasts for at least 2 baseline respiratory cycles and is accompanied by a heart rate slowing of <50 beats / min for at least 5 seconds, or a heart rate slowing of <60 beats / min for at least 15 seconds in infants under 1 year old.

[0048] (8) Central hypoventilation: One type of hypoventilation. It meets the criteria for hypoventilation and does not meet any of the following: ① Snoring is present during the duration of the event; ② Nasal pressure or non-invasive positive pressure ventilation airflow signal is flat compared with baseline breathing; ③ Paradoxical chest and abdominal movements occur during the duration of the event but are not present before the event.

[0049] (9) Snoring: The phenomenon that the upper airway narrows during sleep, and the airflow vibrates the tissues around the upper airway, producing noise.

[0050] (10) Cheyne-Stokes respiration: also known as "Cheyne-Stokes respiration". One of the respiratory events. Alternating between gradually weakening and stopping breathing and gradually increasing breathing. Polysomnography must meet the following criteria simultaneously: ① ≥3 consecutive central sleep apnea and / or central hypopnea, with gradually increasing and decreasing respiratory amplitudes and a cycle duration ≥40 seconds. ② A gradually increasing and decreasing breathing pattern appears during ≥2 hours of sleep monitoring time, with ≥5 central sleep apnea and / or central hypopnea per hour of sleep time.

[0051] (11) Unintentional air leakage: air leakage caused by poor mask contact or mouth breathing when wearing a nose mask.

[0052] (12) Intentional air leakage: Expel carbon dioxide-rich exhaled air through the exhaust port on the ventilator mask to reduce the process of re-inhaling carbon dioxide.

[0053] refer to Figure 1 , Figure 1 This is a schematic diagram of the structure of a testing system provided in an embodiment of this application.

[0054] refer to Figure 1 , Figure 1 This is a schematic diagram of a testing system provided in an embodiment of this application. The testing system may include: a simulated lung 101 for simulating human respiratory movements; an airway obstruction device 102 for simulating airway resistance; and a leaking device 103 for simulating gas leakage. The airway obstruction device 102 and the leaking device 103 are sequentially and fluidly connected between the simulated lung 101 and the ventilator under test, with the airway obstruction device 102 connected between the simulated lung 101 and the leaking device. In some embodiments, fluid communication between the various devices is achieved through tubing connections.

[0055] The simulated lung 101 can be used to simulate a range of normal or central respiratory events, such as normal breathing, snoring, central sleep apnea, central hypoventilation, and Cheyne-Stokes respiration. In some embodiments, the simulated lung 101 can be an active simulated lung. An active simulated lung typically includes a cylinder capable of actively inhaling and exhaling gas, thereby simulating human respiratory movements; and this active simulated lung can precisely simulate inspiratory effort and airflow changes by controlling the piston movement of its internal cylinder, thus producing a highly realistic breathing pattern.

[0056] In some embodiments, examples of respiratory events simulated by the simulated lung 101 include snoring and central apnea. Snoring can be simulated by controlling the oscillation frequency of a cylinder in the simulated lung 101. For example, snoring can be simulated by generating oscillations at each peak of inspiratory respiration, accompanied by a 20% flow restriction. Furthermore, central apnea, characterized by a lack of both airflow and respiratory effort, can be simulated by controlling the simulated lung 101 to reduce both inspiratory effort and flow by 100%.

[0057] In this embodiment of the application, by using a simulated lung to simulate respiratory movements, the APAP device's ability to identify and respond to central respiratory events can be comprehensively evaluated.

[0058] The airway obstruction device 102 can be used to simulate airway collapse, thereby simulating obstructive respiratory events such as obstructive apnea and obstructive hypoventilation by controlling the airway obstruction device 102. In some embodiments, the airway obstruction device simulates physical obstruction of the airway through a controllable (e.g., pressure-controllable) physical structure. For example, simulating obstructive apnea can be achieved by applying a high pressure (e.g., 10 cmH2O) to the airway obstruction device, limiting the flow rate of the simulated lung to the ventilator under test by more than 80%, thus simulating complete or near-complete airway obstruction by the airway obstruction device 102. Simulating obstructive hypoventilation can be achieved by applying a lower pressure, such as 5 cmH2O, limiting the flow rate of the simulated lung to the ventilator under test by more than 50%, thus simulating partial airway obstruction by the airway obstruction device 102. cmH2O is a commonly used unit of pressure, an abbreviation for "centimeter of water column" or "cm water column".

[0059] In some embodiments, the airway obstruction device 102 includes an elastic member capable of quantitatively and repeatably simulating different degrees of physical obstruction to more closely resemble the actual airway structure, thereby improving the simulation effect.

[0060] The leak device 103 is used to connect to a ventilator to simulate unintentional leaks caused by a loose or improperly positioned mask and / or intentional leaks caused by vent holes on the mask during actual use of the APAP device.

[0061] In this embodiment, an air leakage device is used to simulate an air leakage environment, so that the test can be carried out under conditions closer to the real use environment, thereby verifying the robustness of the APAP device under air leakage interference and the anti-interference ability of the algorithm.

[0062] The testing system in this embodiment integrates a simulated lung 101, an airway obstruction device 102, and a leakage device 103 to construct a comprehensive testing platform capable of simultaneously simulating pulmonary / central respiratory events, obstructive respiratory events, and leakage events. This comprehensive simulation capability solves the problem of related technologies and equipment simulating only single or incomplete scenarios, avoiding the cumbersome process of using multiple devices or conducting multiple tests, and greatly improving the efficiency and comprehensiveness of ventilator testing results. This makes the evaluation of APAP device performance closer to real-world clinical scenarios, providing a more reliable and efficient tool for new product development and performance verification.

[0063] In some embodiments, such as Figure 2 and Figure 3 As shown, the air leakage device includes a first solenoid valve group 206, which includes at least a solenoid valve 2061 for controlling the flow of fluid in the pipeline, and a proportional valve 2062 for controlling the amount of air leakage by different opening degrees, wherein the proportional valve can be connected between the solenoid valve and the simulated lung 201.

[0064] The combination of solenoid valve 2061 and proportional valve 2062 enables accurate and dynamic simulation of unintentional gas leaks. In some embodiments, when simulating different gas leak amounts using this first solenoid valve assembly, proportional valve 2062 can be opened to the corresponding degree first, and then solenoid valve 2061 can be controlled to rapidly control the opening and closing of the leak. Compared to a single proportional valve or solenoid valve, this combination offers a faster response time and can simulate leak events with complex waveforms, making the test results closer to real-world conditions.

[0065] In some embodiments, the test system further includes a tee fitting. The tee fitting can be a Y-shaped or T-shaped pipe connector with three ports for converging or diverting multiple airways. The tee fitting is connected between the simulated lung 201 and the ventilator under test 209 via opposing first and second ports. The third port of the tee fitting is connected to a solenoid valve and a proportional valve to bypass the main airway between the simulated lung 201 and the ventilator under test 209, thereby precisely introducing controllable intentional / unintentional leaks through the first solenoid valve group 206 without interfering with the physical connection of the main airway. In this way, the test system can flexibly control whether leak events occur and the magnitude of the leak, thus comprehensively evaluating the ventilator's performance in complex leak environments without affecting the functionality of other test equipment.

[0066] In some embodiments, such as Figure 2 As shown, the leak device also includes a leaking element 207 with a leak hole. In some embodiments, the leak hole on the leaking element 207 is fixed and is used to simulate intentional leaks in a breathing mask. In some embodiments, the leaking element 207 may be connected between a solenoid valve and a simulated lung 201, or between a solenoid valve and a ventilator under test 209.

[0067] In some embodiments, such as Figure 2 and Figure 7 As shown, the leakage element can be a standard air resistance 701 that provides constant leakage. The standard air resistance 701 can achieve an equivalent leakage rate to the exhaust port on a ventilator mask through a fixed-size leakage orifice, used to simulate intentional leakage from the mask's exhaust port. Different specifications of standard air resistances can provide different leakage rates, and the leakage rate used for simulation or testing can be selected according to actual needs. In some embodiments, such as... Figure 5 and Figure 6 As shown, the leaking component 207 can also be a breathing mask 510 worn on a head simulation model to provide a more realistic physiological and leak environment.

[0068] In some embodiments, such as Figure 2 As shown, the test system also includes a pressure generator 204, which is used to provide variable pressure to the airway obstruction device 202.

[0069] In some embodiments, such as Figure 2 and Figure 4 As shown, the airway obstruction device 202 includes a pressure tube 403 and a flexible, deformable ventilation tube 404 located inside the pressure tube 403, with a sealed space between them. The flexible tube 404 is connected to a simulated lung 201 to receive gas supplied by the simulated lung 201. A pressure generator 204 is connected to the pressure tube 403 in the airway obstruction device 202 to apply gas pressure to the sealed space within the airway obstruction device 202, thereby compressing the flexible tube 404. Thus, by applying different pressures through the pressure generator 204, the flexible tube 404 experiences varying degrees of compression, resulting in different degrees of restriction on the gas transmitted from the simulated lung 201 to the ventilator under test 209 through the flexible tube. In some embodiments, the pressure applied by the pressure generator 204 is proportional to the airway resistance / gas restriction simulated by the airway obstruction device 202.

[0070] In some embodiments, the pressure tube 403 can be rigid, for example, made of a rigid material such as UPVC, PE, PP, or PMMA. In other embodiments, the pressure tube 403 can also be flexible, and the airway pressure simulated by the airway obstruction device 202 is determined by the relative change between the pressure tube 403 and the flexible tube 404. In some embodiments, the flexible tube 404 can be, for example, a tube with resilience such as a latex tube or a silicone tube. Taking a latex tube as an example, gas is injected into the pressure tube by a pressure generator to increase the air pressure in the pressure tube field, thereby enabling the flexible tube 404 to be physically squeezed when the simulated lung 201 ventilates the flexible tube 404, accurately simulating events such as obstructive apnea and obstructive hypoventilation.

[0071] The two ends of the pressure tube 403 can be sealed by bolts, threads, or adhesive. In some embodiments, one end of the pressure tube is provided with a first sealing member, and the other end is provided with a second sealing member; the pressure tube closes both ends through the first and second sealing members to form the sealed space. In specific implementations, the sealing member can be any sealing type of component such as a flange or a threaded sealing cap. For example, as shown... Figure 4 As shown, a first flange 301 and a second flange 302 are installed at both ends of the pressure pipe to seal both ends. This design aims to ensure that the annular space between the pressure pipe and the latex tubing is a completely sealed cavity, thereby effectively bearing the air pressure applied by the pressure generator and uniformly transmitting it to the latex tubing. This structure ensures the sealing and operational stability of the airway blocking device 202, which is a prerequisite for achieving precise and controllable blocking. It prevents the applied pressure from leaking, ensuring the accuracy of the blocking pressure, thereby improving the repeatability and quantitative accuracy of the simulated event.

[0072] In some embodiments, the first sealing member is provided with a first interface 3011, and the second sealing member is provided with a second interface 3021. The first interface and the second interface are respectively connected to the opposite ends of the flexible tube to transmit the gas received by the flexible tube from the simulated lung 201 to the external pipeline, thereby establishing the core airflow path of the entire test system.

[0073] In some embodiments, the airway obstruction device 202 may also include a butterfly valve. A butterfly valve controls flow by rotating a valve disc to change the area of ​​the airflow passage. However, compared to the airway obstruction device 202, which restricts gas flow through flexible tube deformation, the flow restriction caused by the rotation of the butterfly valve disc is fundamentally different from the physical process of human airway obstruction. Human airway obstruction is usually caused by soft tissue collapse or posterior displacement of the tongue base, and its hydrodynamic characteristics are complex. The butterfly valve simply changes the physical cross-sectional area and cannot realistically simulate the dynamic changes in airway resistance. This difference in simulation may lead to discrepancies between the test results of the ventilator algorithm and actual clinical manifestations.

[0074] The embodiments of this application can achieve different degrees of flow restriction by precisely controlling the applied pressure (e.g., flow restriction ≥80% for obstructive apnea, flow restriction ≥50% for obstructive hypoventilation), making obstruction simulation more quantitative and repeatable.

[0075] In some embodiments, the pressure generator 204 may include a fan that supplies gas pressure to the airway obstruction device 202 by rotating the fan. In some embodiments, the pressure variation supplied to the airway obstruction device 202 can be adjusted by controlling the on / off state and / or operating efficiency (e.g., fan speed) of the pressure generator 204. In some embodiments, such as Figure 2 As shown, the test system also includes a second solenoid valve group 203, which is used to adjust the gas pressure supplied by the pressure generator to the airway blocking device 202.

[0076] In some embodiments, to apply controllable pressure to the airway obstruction device 202 and rapidly release pressure, the second solenoid valve assembly 203 may include a pressure-increasing valve and a first venting valve, which are sequentially connected between the pressure generator and the airway obstruction device 202, with the first venting valve connected between the pressure-increasing valve and the airway obstruction device 202. In this embodiment, the pressure-increasing valve controls the flow of fluid through the pipeline between the pressure generator and the airway obstruction device 202. In a specific implementation, the pressure-increasing valve determines when the pressure from the pressure generator is applied to the pressure pipe, thereby controlling the start and end of the obstruction event. The first venting valve controls the airway obstruction device 202 to release pressure to the external environment. In a specific implementation, the first venting valve is connected between the pressure-increasing valve and the airway obstruction device 202 to rapidly release the pressure inside the pressure pipe to the external environment after the obstruction event ends.

[0077] By coordinating the pressurizing valve and the first venting valve, the duration and intensity of the obstruction event can be precisely controlled. For example, when it is necessary to end an obstruction event, the pressurizing valve closes while the first venting valve opens, allowing the pressure inside the airway obstruction device 202 to quickly return to zero, thereby simulating a state where the airway is rapidly restored to patency.

[0078] In some embodiments, the pressure generator can remain operational throughout the testing process. To prevent the pressure generator from overheating, in some embodiments, the second solenoid valve assembly 203 may further include a second vent valve connected between the pressurizing valve and the pressure generator to control the pressure generator's pressure release to the external environment. Specifically, when the pressurizing valve is closed, the air passage between the pressure generator and the airway blocking device 202 is blocked. In this situation, if the fan inside the pressure generator continues to operate, it will be in a "pressure buildup" state. This state can cause the fan to overload and generate a large amount of heat, potentially damaging the equipment. Therefore, by adding a second vent valve, a pressure relief path can be provided to the pressure generator when the pressurizing valve is closed, allowing the internal fan to operate normally without pressure buildup, thereby protecting the equipment and extending its service life.

[0079] In some embodiments, to quantitatively evaluate the response and therapeutic effect of the ventilator under test 209 in response to simulated different respiratory events, this application embodiment can configure a data acquisition device 208 in the test system. This data acquisition device 208 can be used to monitor pressure and / or flow changes in the tubing between the airway obstruction device 202 and the ventilator under test 209. This data can serve as objective data quantified during the interaction testing process between the ventilator and the test system, and can provide raw data for subsequent detailed analysis. By analyzing the data acquired by the data acquisition device 208, various key performance indicators of the ventilator under test 209 in respiratory event recognition can be calculated.

[0080] For example, to verify the accuracy of the respiratory event simulation, the flow data collected by the data acquisition device 208 can confirm whether the airway obstruction device 202 actually produced the expected flow change, such as flow restriction exceeding 80%, thus ensuring the accuracy of the test environment. To evaluate the ventilator's response to respiratory events, the pressure changes monitored by the data acquisition device 208 can be used to observe whether the ventilator can promptly increase the delivery pressure when an obstruction event occurs, and whether the magnitude and speed of its pressure adjustment meet expectations, thereby determining the effectiveness of the ventilator's respiratory event recognition and treatment algorithms. When test results are unsatisfactory, analyzing the pressure and flow data can help engineers diagnose problems. For example, the ventilator may have failed to correctly recognize the event, or its output pressure may have failed to meet treatment requirements.

[0081] In some embodiments, the data acquisition device 208 includes a ventilator testing instrument. The ventilator testing instrument is a multifunctional device capable of simultaneously monitoring flow and pressure. The ventilator testing instrument can be connected between the airway obstruction device 202 and the leak device, located at the core of the airway, and can accurately and effectively record the core parameters of gas pressure and flow changes in the tubing of the testing system. In some embodiments, such as Figure 2 , Figure 5 and Figure 6 As shown, the data acquisition device 208 (e.g., a ventilator testing instrument) includes one flow port and two pressure ports. The flow port is connected to a leak device, near the side of the simulated lung 201. For example, a leak device 207 used to simulate intentional leaks is connected to the flow port of the ventilator testing instrument, allowing the instrument to monitor the flow rate of gas supplied to the ventilator under test 209 via the airway obstruction device 202 without gas leakage. By monitoring changes in airway flow, this flow rate data can be used to identify whether a respiratory event has occurred and the ventilator's response to the event. Pressure port 1 is connected to the leak device near the side of the ventilator under test 209, for example, at the second port of a three-way fitting connected to the ventilator under test 209. This port is used to monitor the pressure received by the ventilator under test 209 and the pressure output by the ventilator under test 209, thereby monitoring the pressure change in the tubing before and after the ventilator under test 209's response. Pressure port 2 is connected to the airway obstruction device 202 and is used to monitor the pressure change within the pressure tube of the airway obstruction device 202. In some embodiments, a third interface 4012 is provided on the first sealing member 401 (e.g., a first flange) or the second sealing member 402 (e.g., a second flange) of the airway blocking device 202, the third interface 4012 being in communication with the sealed space between the pressure tube 403 and the flexible tube 404.

[0082] In some embodiments, such as Figure 7 As shown, the data acquisition device includes a first pressure gauge 702, a second pressure gauge 703, and a flow meter (which may be referred to as the first flow meter 704 for easy distinction). The first pressure gauge 702 monitors the pressure of the gas received or exhaled by the ventilator under test; this data directly reflects the operating pressure of the ventilator. Exemplarily, the first pressure gauge 702 can be connected to the tubing near the leaking device on the side of the ventilator under test 209. The second pressure gauge 703 monitors pressure changes inside the airway obstruction device; this data directly reflects the degree of obstruction and the pressure applied by the pressure generator. Exemplarily, the second pressure gauge 703 can be connected to the tubing between the pressure generator and the airway obstruction device (or the second solenoid valve assembly). The first flow meter 704 monitors the inspiratory and expiratory flow rates of the ventilator under test; this data is also a key reference for evaluating the ventilator's response to events. Exemplarily, the first flow meter can be connected to the tubing between the airway obstruction device and the leaking device.

[0083] In some embodiments, such as Figure 6 As shown, the data acquisition device also includes a second flow meter 601, which can be connected between the first solenoid valve assembly used to simulate unintentional leakage and the leaking component or breathing mask used to simulate intentional leakage, to monitor the amount of gas leaked unintentionally. The monitoring data from the second flow meter 601 can be used for closed-loop control of the leakage amount under different pressures.

[0084] In some embodiments, such as Figure 2 , Figures 5 to 7 As shown, the testing system may further include a control device for controlling the operation of the simulated lung 201, the airway obstruction device 202, and the leak device according to a pre-set program to simulate respiratory events. In some embodiments, the control device may also acquire monitoring data from a data acquisition device and, based on the monitoring data, generate an evaluation result for assessing the response performance of the ventilator under test 209 to respiratory events.

[0085] In some embodiments, the control procedures for different respiratory events, as well as the entire test procedure for the ventilator under test 209, are stored in the control device in the form of scripts. Testers can simulate or test respiratory events at different levels by selecting different degrees on the display screen of the control device.

[0086] In some embodiments, the control device is signal-connected to the simulated lung 201 to control the movement of cylinders within the simulated lung 201 to simulate human breathing. In some embodiments, the control device can also be used to control the oscillation frequency of the cylinders to simulate snoring. In some embodiments, the testing system may further include a loudspeaker to superimpose snoring signals onto the loudspeaker, which is external to the simulated lung 201. The loudspeaker primarily emits acoustic signals and produces weaker airflow oscillations; in contrast, the snoring generated by the cylinder movement of the simulated lung 201 is primarily airflow oscillation, thus more realistically simulating human snoring.

[0087] In some embodiments, such as Figure 2 As shown, the control device may include a lower-level controller 205, which is signal-connected to the first solenoid valve group and the second solenoid valve group 203, and is used to control the first solenoid valve group and the second solenoid valve group 203, thereby controlling the operation of the air leakage device and the airway blockage device 202.

[0088] In some embodiments, such as Figure 2As shown, the control device may further include a main controller 210, which is signal-connected to the lower-level controller 205 and is used to send control signals to the lower-level controller 205, so that the lower-level controller 205 controls the first solenoid valve group 206 and the second solenoid valve group 203 based on the control signals. In some embodiments, such as Figure 2 and Figure 7 As shown, the main controller 210 is also signal-connected to the data acquisition device for acquiring monitoring data from the data acquisition device. The main controller 210 can be used for data analysis and processing. In some embodiments, the lower-level controller 205 or the main controller 210 may store a calibration relationship between the pressure of the pressure generator and the airway resistance provided by the airway obstruction device 202, so that the control device can determine the airway resistance provided by the airway obstruction device 202 based on the gas pressure in the pressure tube fed back by the data acquisition device and the calibration relationship. In some embodiments, the main controller 210 is also signal-connected to the simulated lung 201 for controlling the operation of the simulated lung 201. In other embodiments, the simulated lung 201 may be signal-connected to the lower-level controller 205 and controlled by the lower-level controller 205 according to the control signals issued by the main controller 210.

[0089] In some embodiments, the control device may also be connected to the ventilator under test to acquire recorded data from the ventilator. This recorded data includes identification data of respiratory events simulated by the test system, including the number and / or type of respiratory events. In some embodiments, the control device is not connected to the ventilator under test. The respiratory event identification data of the ventilator under test can be stored in the ventilator's data storage card (e.g., an SD card), and the control device (e.g., a main controller) can acquire the recorded data of the ventilator under test by reading this data storage card. In some embodiments, the control device (e.g., the main controller) may integrate one or more data analysis software programs for analyzing the recorded data of the ventilator under test and the flow / pressure monitoring data acquired by the data acquisition device, thereby quantitatively evaluating the ventilator's performance in identifying and responding to different respiratory events.

[0090] Although preferred embodiments of the present invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the present invention.

[0091] Finally, it should be noted that in this document, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or terminal device that includes said element.

[0092] The above description is merely a specific embodiment of this utility model, but the protection scope of this utility model is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in this utility model should be included within the protection scope of this utility model. Therefore, the protection scope of this utility model should be determined by the scope of the claims.

Claims

1. A testing system for ventilators, characterized in that, The testing system includes: Simulated lungs used to simulate human respiratory movements; Airway obstruction device used to simulate airway resistance; A leak detector used to simulate gas leaks; The airway obstruction device and the air leakage device are sequentially and fluidly connected between the simulated lung and the ventilator under test, and the airway obstruction device is connected between the simulated lung and the air leakage device.

2. The testing system according to claim 1, characterized in that, The air leakage device includes a solenoid valve for controlling the flow of fluid in the pipeline, and a proportional valve for controlling the amount of air leakage by different opening degrees, wherein the proportional valve is connected between the solenoid valve and the simulated lung.

3. The testing system according to claim 2, characterized in that, The testing system also includes a three-way connector, which is connected between the simulated lung and the ventilator under test via opposing first and second ports, and the third port of the three-way connector is connected to the solenoid valve and the proportional valve.

4. The testing system according to claim 2, characterized in that, The air leakage device also includes an air leakage component with a leakage hole, which is connected between the solenoid valve and the simulated lung or between the solenoid valve and the ventilator under test. The air leakage component is a standard air resistance or a breathing mask worn on a head simulation model.

5. The testing system according to claim 1, characterized in that, The airway obstruction device includes a pressure tube and a flexible, deformable ventilation tube; the flexible tube is located inside the pressure tube, and a sealed space exists between the flexible tube and the pressure tube; the flexible tube is connected to the simulated lung. The testing system also includes a pressure generator connected to the pressure tube for applying gas pressure to the confined space to compress the flexible tube.

6. The testing system according to claim 5, characterized in that, The testing device further includes a pressure valve and a first vent valve, which are sequentially connected between the pressure generator and the airway blocking device. The first vent valve is connected between the pressure valve and the airway blocking device. The pressure valve is used to control the flow of fluid in the pipeline between the pressure generator and the airway blocking device, and the first vent valve is used to control the airway blocking device to release pressure to the external environment.

7. The testing system according to claim 6, characterized in that, The testing device also includes a second vent valve, which is connected between the pressurizing valve and the pressure generator, and is used to control the pressure generator to release pressure to the external environment.

8. The testing system according to any one of claims 1-7, characterized in that, The testing system also includes a data acquisition device for monitoring pressure and / or flow changes in the tubing between the airway obstruction device and the ventilator under test.

9. The testing system according to claim 8, characterized in that, The data acquisition device includes a ventilator testing unit, which is connected between the airway obstruction device and the leakage device; or... The data acquisition device includes a first pressure gauge, a second pressure gauge, and a flow meter. The first pressure gauge is used to monitor the gas pressure received or exhaled by the ventilator under test. The second pressure gauge is used to monitor the pressure change of the airway obstruction device. The flow meter is used to monitor the inspiratory and expiratory flow rates of the ventilator under test.

10. The testing system according to claim 1, characterized in that, The testing system also includes a control device, which controls the operation of the simulated lung, the airway obstruction device, and the leakage device according to a set program to simulate respiratory events.

11. The testing system according to claim 10, characterized in that, The simulated lung includes a cylinder, and the control device is used to control the oscillation frequency of the cylinder to simulate snoring.

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