Pulmonary function test system and test device

Abstract

This invention discloses a testing system and apparatus for a pulmonary function instrument. The testing system includes a differential pressure sampling module, a pulmonary function detection module, a main processor, and a terminal. The differential pressure sampling module is connected to the pulmonary function instrument and is used to collect differential pressure data from the flow sensor in the instrument. The pulmonary function detection module is connected to the pulmonary function instrument and is used to simulate the respiratory process according to instructions from the main processor. The main processor receives instructions from the terminal and controls the operation of the differential pressure sampling module and the pulmonary function detection module accordingly. It also collects and calculates the detection data from these modules and sends the data to the terminal. The terminal sends instructions containing test parameters to the main processor and stores the detection data returned by the main processor. This invention provides a testing system and apparatus for pulmonary function instruments, enabling the testing of pulmonary ventilation function, pulmonary diffusion function, and differential pressure, thus solving the problem of difficult performance evaluation of large pulmonary function instruments.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a testing system and device for a pulmonary function instrument. Background Technology

[0002] In clinical medical testing, pulmonary function tests are becoming increasingly common and are one of the essential examinations for respiratory diseases. In particular, they are used to test the patency of the airways and the size of the lungs. They are especially important for early detection of lung and airway lesions, assessment of the severity and prognosis of diseases, evaluation of the efficacy of drugs or other treatments, identification of the cause of dyspnea, diagnosis of the location of lesions, assessment of the lungs' tolerance to surgery or labor intensity, and monitoring of critically ill patients.

[0003] There are numerous pulmonary function tests, and the accuracy of pulmonary function parameters is crucial. Pulmonary function tests require the use of pulmonary function analyzers. Currently, large-scale pulmonary function analyzers are mainly from European and American brands, and the performance of these analyzers varies greatly. There are currently no established performance testing standards, and specialized testing equipment is lacking. Performance evaluation mainly relies on long-term clinical experience and reputation building. Current pulmonary function testing devices can only produce a single ATS waveform, flow rate, or volume; some only measure gas concentration. They can only evaluate basic flow and concentration data, and cannot provide a complete test and evaluation of the performance of large-scale pulmonary function analyzers. This is highly detrimental to the promotion and development of domestically produced pulmonary function analyzers, which started relatively late in the field. Summary of the Invention

[0004] The main technical problem solved by this invention is to provide a testing system and device for a pulmonary function instrument, providing a complete and scientific testing device for testing pulmonary ventilation function, pulmonary diffusion function and pressure difference, solving the problem of difficult performance evaluation of large pulmonary function instruments, and providing assistance for the design, development, comprehensive performance improvement and standardization of large pulmonary function instruments.

[0005] To solve the above-mentioned technical problems, one technical solution adopted by the present invention is: to provide a testing system for a pulmonary function instrument, the testing system comprising a differential pressure sampling module, a pulmonary function detection module, a main processor, and a terminal;

[0006] The differential pressure sampling module is connected to the pulmonary function instrument and is used to collect differential pressure data from the flow sensor in the pulmonary function instrument and send the differential pressure data to the main processor.

[0007] The lung function testing module is connected to the lung function instrument and is used to simulate the breathing process according to the instructions of the main processor and send the test data to the main processor.

[0008] The main processor is used to receive instructions from the terminal, control the operation of the differential pressure sampling module and the lung function detection module according to the instructions, collect and calculate the detection data of the differential pressure sampling module and the lung function detection module, and send the detection data to the terminal.

[0009] The terminal is used to send instructions containing test parameters to the main processor and to store the detection data returned by the main processor.

[0010] The lung function testing module includes a lung ventilation function testing module and a lung diffusion function testing module. The lung ventilation function testing module is used to simulate the lung ventilation testing process, and the lung diffusion function testing module is used to simulate the lung diffusion testing process.

[0011] The lung ventilation function detection module includes an air chamber, a first control module, a first valve control unit, and several first solenoid valves.

[0012] The air chamber is used to supply test gas to the pulmonary function instrument;

[0013] The first control module is used to control the opening and closing of the air chamber;

[0014] The first valve control unit is used to control the opening and closing of the first solenoid valve.

[0015] The lung diffusion function detection module includes a gas mixing chamber, a second control module, a multi-concentration gas mixing device, and a gas calibration module.

[0016] The gas mixing chamber is used to provide test gas to the pulmonary function instrument;

[0017] The second control module is used to control the opening and closing of the gas mixing chamber;

[0018] The multi-concentration gas mixing device is used to prepare the gas with the required composition for the test gas;

[0019] The gas calibration module is used to detect and calibrate the composition of the test gas.

[0020] The gas calibration module includes multiple gas cylinders, a gas chamber, a solenoid valve group, and a second valve control unit.

[0021] The plurality of gas cylinders are all connected to the gas chamber via pipelines;

[0022] The gas chamber is used to mix the gas stored in the gas cylinder;

[0023] The second valve control unit is used to control the opening and closing of the solenoid valve group and the pipeline in which the solenoid valve group is located.

[0024] Both the first control module and the second control module include a grating displacement sensor and a linear motor;

[0025] Both the air chamber and the mixed gas chamber include a pull rod, the linear motor is used to drive the pull rod to reciprocate, and the grating displacement sensor is used to detect the displacement of the pull rod.

[0026] Both the lung ventilation function detection module and the lung diffusion function detection module include a humidification and heating unit and a temperature and humidity sensor.

[0027] The humidification and heating module is used to heat and humidify the gas in the air chamber and the mixed gas chamber;

[0028] The temperature and humidity sensor is used to detect the temperature and humidity of the gas in the air chamber and the mixed gas chamber.

[0029] The differential pressure acquisition module includes a differential pressure sensor and a differential pressure signal processing unit. The differential pressure sensor is electrically connected to the flow sensor of the pulmonary function instrument and is used to detect the differential pressure of the flow sensor. The differential pressure signal processing unit is electrically connected to the differential pressure sensor and is used to receive the differential pressure data measured by the differential pressure sensor, convert and process it, and then send it to the main processor.

[0030] The differential pressure sensor includes a first differential pressure sensor and a second differential pressure sensor. The range of the first differential pressure sensor is 0 to ±250 Pa, and the range of the second differential pressure sensor is 0 to ±1.5 kPa.

[0031] The differential pressure acquisition module also includes a valve control module, which is used to switch the opening and closing of the first differential pressure sensor and the second differential pressure sensor.

[0032] To address the technical problem, the present invention also provides a testing device for a pulmonary function instrument, which is used to test the pulmonary function instrument. The testing device includes a differential pressure sampling component, a pulmonary function detection component, and a terminal host.

[0033] The terminal host includes an input panel, a CPU, and a display screen. The input panel is used to input preset data. The CPU calculates lung function test data based on the preset data and compares it with the results of the lung function instrument. The display screen is used to display the test results.

[0034] The differential pressure sampling component is connected to the pulmonary function instrument and is used to detect the differential pressure of the flow sensor in the pulmonary function instrument;

[0035] The lung function testing component is connected to the lung function instrument and is used to simulate the lung function testing process based on the preset data.

[0036] Compared with the prior art, the beneficial effects of the pulmonary function instrument testing system and testing device of the present invention are as follows: it provides a complete and scientific testing system for testing pulmonary ventilation function, pulmonary diffusion function and pressure difference, solves the problem of difficult performance evaluation of large pulmonary function instruments, and provides assistance for the design and development of large pulmonary function instruments, comprehensive performance improvement and standardization. Attached Figure Description

[0037] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0038] Figure 1 This is a schematic diagram of the testing system of the pulmonary function instrument of the present invention;

[0039] Figure 2 This is a schematic diagram of a pulmonary function testing device;

[0040] Figure 3 This is a schematic diagram of the first connection method between the testing system and the pulmonary function instrument;

[0041] Figure 4 This is a schematic diagram of the second connection method between the testing system and the pulmonary function instrument;

[0042] Figure 5 This is a structural block diagram showing the connection between the testing system and the pulmonary function instrument;

[0043] Figure 6 This is a flowchart of flow rate and capacity accuracy detection;

[0044] Figure 7 This is a flowchart of the chronic lung capacity test;

[0045] Figure 8 This is a slow vital capacity breathing waveform diagram;

[0046] Figure 9 This is a graph of forced lung capacity;

[0047] Figure 10 This is a flowchart of the lung diffusion detection process. Detailed Implementation

[0048] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0049] In this embodiment of the invention, all directional indications (such as up, down, left, right, front, back, etc.) are only used to explain the relative positional relationships and movement of the components in a specific posture (as shown in the accompanying drawings). If the specific posture changes, the directional indications will also change accordingly. The terms "first," "second," etc., used in this application are used to distinguish different objects, not to describe a specific order. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0050] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0051] The present invention provides a testing system for a pulmonary function instrument. The testing system includes a differential pressure sampling module, a pulmonary function detection module, a main processor, and a terminal. The differential pressure sampling module is connected to the pulmonary function instrument and is used to collect differential pressure data from the flow sensor in the pulmonary function instrument and send the differential pressure data to the main processor. The pulmonary function detection module is connected to the pulmonary function instrument and is used to simulate the breathing process according to the instructions of the main processor and send the detection data to the main processor. The main processor is used to receive instructions from the terminal and control the operation of the differential pressure sampling module and the pulmonary function detection module according to the instructions, as well as collect and calculate the detection data from the differential pressure sampling module and the pulmonary function detection module, and send the detection data to the terminal. The terminal is used to send instructions containing test parameters to the main processor and store the detection data returned by the main processor.

[0052] The differential pressure sampling module in this application is mainly used to detect the differential pressure of the flow sensor of the pulmonary function instrument. The pulmonary function detection module is used to detect the data of the pulmonary function instrument when performing various pulmonary function tests. After the detection data is converted and calculated by the main processor, it is stored in the terminal and displayed on the external display device, thereby verifying the measurement accuracy of the pulmonary function instrument.

[0053] The pulmonary function testing module in this application includes a pulmonary ventilation function testing module and a pulmonary diffusion function testing module. The pulmonary ventilation function testing module is used to simulate the pulmonary ventilation testing process, and the pulmonary diffusion function testing module is used to simulate the pulmonary diffusion testing process. The most commonly used pulmonary function tests are the pulmonary ventilation function and pulmonary diffusion function tests, and the test data are of great significance for understanding the condition of human lungs. Therefore, the testing module in this application only covers the above two tests.

[0054] The pulmonary ventilation function testing module includes an air chamber, a first control module, a first valve control unit, and several first solenoid valves. The air chamber supplies test gas to the pulmonary function instrument, simulating the human exhalation and inhalation process. The first control module controls the opening and closing of the air chamber. The first valve control unit controls the opening and closing of the first solenoid valves.

[0055] The pulmonary diffusion function testing module includes a gas mixing chamber, a second control module, a multi-concentration gas mixing device, and a gas calibration module. The gas mixing chamber supplies test gas to the pulmonary function instrument, simulating the human exhalation and inhalation process. The second control module controls the opening and closing of the gas mixing chamber. The multi-concentration gas mixing device prepares the required components of the test gas, and the gas calibration module detects and calibrates the composition of the test gas.

[0056] The gas calibration module in this application includes multiple gas cylinders, a gas chamber, a solenoid valve assembly, and a second valve control unit. The gas cylinders are connected to the gas chamber via pipelines, and each cylinder stores a different gas. The gas chamber is used to mix the gases stored in the gas cylinders, and the second valve control unit is used to control the opening and closing of the solenoid valve assembly and the pipeline containing it.

[0057] Both the first and second control modules in this application include a grating displacement sensor and a linear motor. Both the air chamber and the mixed gas chamber include a pull rod. The linear motor drives the pull rod to reciprocate, and the grating displacement sensor detects the displacement of the pull rod. During the reciprocating motion, the pull rod pushes the gas in the air chamber and the mixed gas chamber, simulating exhalation and inhalation.

[0058] Both the pulmonary ventilation function testing module and the pulmonary diffusion function testing module in this application include a humidification and heating unit and a temperature and humidity sensor. The humidification and heating module is used to heat and humidify the gas in the air chamber and the mixed gas chamber; the temperature and humidity sensor is used to detect the temperature and humidity of the gas in the air chamber and the mixed gas chamber. Certain requirements are placed on temperature and humidity during the test; therefore, the temperature and humidity of the gas in the air chamber and the mixed gas chamber need to be adjusted before the test.

[0059] The differential pressure acquisition module in this application includes a differential pressure sensor and a differential pressure signal processing unit. The differential pressure sensor is electrically connected to the flow sensor of the pulmonary function instrument and is used to detect the differential pressure of the flow sensor. The differential pressure signal processing unit is electrically connected to the differential pressure sensor and is used to receive the differential pressure data measured by the differential pressure sensor, convert and process it, and then send it to the main processor.

[0060] The differential pressure sensor in this application includes a first differential pressure sensor and a second differential pressure sensor. The first differential pressure sensor has a range of 0 to ±250 Pa, and the second differential pressure sensor has a range of 0 to ±1.5 kPa, respectively suitable for measurement of different ranges. The differential pressure acquisition module also includes a valve control module, which is used to switch the opening and closing of the first and second differential pressure sensors.

[0061] To address the technical problem, the present invention also provides a testing device for a pulmonary function instrument, used for testing the pulmonary function instrument. The testing device includes a differential pressure sampling component, a pulmonary function detection component, and a terminal host. The terminal host includes an input panel, a CPU, and a display screen. The input panel is used to input preset data, the CPU calculates pulmonary function test data based on the preset data and compares it with the results of the pulmonary function instrument, and the display screen is used to display the test results. The differential pressure sampling component is connected to the pulmonary function instrument and is used to detect the differential pressure of the flow sensor in the pulmonary function instrument. The pulmonary function detection component is connected to the pulmonary function instrument and is used to simulate the pulmonary function testing process based on preset data.

[0062] The basic structure of a pulmonary function instrument is as follows: Figure 1 As shown, the system includes a gas flow detection module consisting of a flow sensor 0001, a pressure tap 0011, and a differential pressure sensor 0009; a gas concentration detection module consisting of a gas sampling tube / drying tube 0002, an inhalation pump 0003, a gas signal sensor 0004, a gas chamber 0005, a laser module 0006, a gas module processor 0007, and an outlet 0008; and an electromagnetic shut-off valve 0012, an on-demand valve 0013, and a mixed gas-high-pressure cylinder 0014 used for diffusion testing. The pulmonary function instrument primarily acquires the gas flow rate and the concentrations of carbon monoxide and methane in the gas in real time through the flow sensor and the gas concentration detection module. These two raw data are processed by the processor 0010 to obtain pulmonary function parameters and pulmonary diffusion parameters according to different testing requirements.

[0063] A schematic diagram of the pulmonary function testing system is shown below. Figure 2 As shown, the testing system includes a differential pressure sampling module, a lung function testing module, a main processor, and a terminal.

[0064] Please see Figure 3 , Figure 3 This is a schematic diagram of the first connection method between the test system and the pulmonary function instrument. The two pressure taps of the flow sensor of the pulmonary function instrument are connected to the pressure taps P+ and P- of the detection device. In this way, the flow sensor based on the differential pressure principle can be calibrated.

[0065] First, the implementation plan, function, and control method of the differential pressure sampling module are explained. The differential pressure sampling device is connected to the flow sensor of the pulmonary function instrument. The differential pressure signal of the flow sensor is obtained through the differential pressure sensor. The differential pressure signal is sent to the main processor after analog-to-digital conversion and signal processing by the differential pressure signal processing module. The differential pressure data can be used for the calibration of the flow sensor.

[0066] The differential pressure sampling module offers two options: a large range and a small range. The small range value is within 0 to ±250 Pa, which meets the calibration requirements for small flow rates. The large range value is within 0 to ±1.5 kPa, which meets the calibration requirements for large flow rates.

[0067] Differential pressure sensor P1 represents the connection of the large and small range pressure taps to one end of the pressure tap P+, and differential pressure sensor P2 represents the connection of the large and small range pressure taps to one end of the pressure tap P-.

[0068] The differential pressure sampling module uses the differential pressure signal from the large-range flow sensor. When the differential pressure signal (P+—P-) is within the large-range range of 250Pa or <-250Pa, the main processor sends a start large-range test signal to the valve control module. The two-position three-way solenoid valve controlled by the valve control module is energized. At this time, the pressure tap P- is connected to the large-range pipeline, and the pressure tap P+ is connected to the large-range pipeline. At this time, the differential pressure signal from the large-range flow sensor can be used to measure the flow.

[0069] The differential pressure sampling module uses the differential pressure signal from the small-range flow sensor. When the differential pressure signal (P+—P-) is ≤250Pa or ≥-250Pa within the small-range range, the main processor sends a start small-range measurement signal to the valve control module. The two-position three-way solenoid valve controlled by the valve control module is de-energized. At this time, the pressure tap P- is connected to the small-range pipeline, and the pressure tap P+ is connected to the small-range pipeline. At this time, the differential pressure signal from the small-range flow sensor can be used.

[0070] Please see Figure 4 , Figure 4This is a schematic diagram of the second connection method between the testing system and the pulmonary function instrument. The mouthpiece of the pulmonary function instrument is connected to the ventilation interface of the testing device. At this time, the testing system and device can test the pulmonary function instrument's pulmonary ventilation function and diffusion function.

[0071] The following describes the implementation plan, functions, and control methods of the lung function testing module. Using the lung function testing module, the expiratory flow rate, inspiratory flow rate, and various respiratory waveforms can be output according to the user's needs.

[0072] Technical parameters of the pulmonary function testing module: output waveform flow rate range 0~±20L / S, volume range of a single exhalation or inhalation 0~10L, accuracy of flow rate and volume ±1%. Temperature setting range for exhaled gas 30℃~37℃, humidity setting range 50%~100%;

[0073] Using the output respiratory waveform of the lung function testing module, the main processor first receives the respiratory waveform data file from the computer's application software. The main processor then sends the flow rate value per unit cycle to the fully closed-loop control module. The fully closed-loop control module consists of a grating displacement sensor module and a linear motor drive system. The grating displacement sensor module measures the data and calculates it to obtain real-time flow rate data. The linear motor drive system drives the air chamber lever to move. The two form a closed-loop control system, thereby achieving high-precision control. Currently available mature fully closed-loop control systems can be used.

[0074] The grating displacement sensor can detect the movement of the air chamber rod in real time. Multiplying the movement by the cross-sectional area of ​​the air chamber gives the change in the volume of the air chamber. Dividing the change in volume by the change time gives the gas flow rate.

[0075] The respiratory waveform data file consists of N sets of data points (flow rate and time), with each data point having a time interval of 0.002 seconds, which achieves a change rate of 500 Hz. This meets the detection requirements of flow sensors with response frequencies below 500 Hz.

[0076] The lung function detection module controls the exhaled gas at a specified temperature and humidity. First, the temperature and humidity values ​​of the exhaled gas are set in the computer application software and sent to the main processor. The main processor controls the opening and closing of the solenoid valve to allow air to enter through the solenoid valve and sends a control signal to the humidification and heating module to heat and humidify the air entering the air chamber. The temperature and humidity sensor detects the temperature and humidity of the air in the air chamber in real time. When the set temperature and humidity are reached, the main processor controls the humidification and heating module to stop heating and humidifying.

[0077] The data measured by the grating displacement sensor module is processed by the main processor to obtain real-time flow data. The flow data is then sent to the computer application software in real time. The computer application software can use the flow data to calculate lung function parameters or lung diffusion parameters according to different detection types.

[0078] The mixed gas output control module is used to control the output of a breathing waveform with specific concentrations of carbon monoxide and methane gas.

[0079] The mixed gas is stored in the mixing chamber. First, the computer software sends the user-set concentration value of the exhaled mixed gas, the total volume of exhaled gas, and the exhaled waveform data to the main processor. The mixed gas inlet pipe is opened, allowing gas from the mixed gas-high-pressure cylinder to enter the mixing chamber. The main processor sends control commands to the valve control module, which then sends control signals to open the solenoid valve, energize the two-position three-way solenoid valve to connect the gas distribution device to pipeline number 1, open the on-demand valve, and energize the two-position three-way valve to connect pipeline number 2 and pipeline number 3 to the mixing chamber.

[0080] The gas mixture concentration is set so that the gas distribution device outputs gas at the desired concentration. The main processor sends data parameters to the gas distribution device. The gas mixture from the source gas cylinder and the high-pressure gas cylinder is processed by the gas distribution device to obtain a gas mixture of the required concentration. The gas distribution device can use currently mature gas distribution equipment. The gas mixture enters the gas mixing chamber, and the main processor sends volume parameters to the fully closed-loop control module. The fully closed-loop control module moves the lever of the gas mixing chamber to the set position through a linear motor and a grating displacement sensor module.

[0081] The gas mixing chamber is opened to the ventilation interface line, and the mixed gas is output through the gas line to the flow sensor and gas measurement module of the pulmonary function instrument. The main processor sends a control signal to the valve control module, which de-energizes the two-position three-way solenoid valve, at which point the gas mixing chamber is connected to the pipeline. The main processor then sends a control signal to the valve control module, which energizes the two-position three-way solenoid valve, thus connecting the ventilation line.

[0082] The gas calibration module comprises multiple mixed gas-high-pressure cylinders, a solenoid valve assembly consisting of multiple solenoid valves, and a gas chamber. The gas calibration module rapidly outputs mixed gases of different concentrations. Each mixed gas cylinder corresponds to a specific gas concentration, and each cylinder is connected to a gas passage in the solenoid valve assembly via a pipeline, with each cylinder corresponding to a specific gas concentration. The valve control module receives control commands from the main processor and, based on these commands, opens the specified gas passage in the solenoid valve assembly. This process selects different concentrations of mixed gas. The mixed gas enters the ventilation port through pipeline number one, while simultaneously closing the solenoid valve number one, disconnecting gas passage number one, and connecting pipeline number two to the ventilation port.

[0083] The detection device includes a main circuit board, which receives various data and control commands from the computer application software, controls each module through the main processor, and provides each hardware module with power supply voltages such as +3.3V, +5V, +12V, and +24V. The communication module is connected to the computer through a USART or USB interface.

[0084] Please see Figure 5 , Figure 5 This is a block diagram showing the connection between the testing system and the pulmonary function analyzer. The testing device is connected to a computer via a communication interface. The user operates the application software on the computing platform to select the required functional modules for testing. The application software includes flow accuracy testing, volume accuracy testing, slow vital capacity testing, forced vital capacity testing, maximum spontaneous ventilation testing, analog waveform testing, flow sensor calibration, performance testing of methane and carbon monoxide gas concentration sensors, and DLCO performance testing.

[0085] This embodiment describes a flow rate and volume accuracy detection scheme. Flow rate accuracy detection involves measuring the accuracy of the flow sensor in the pulmonary function instrument for measuring gas flow rate and volume accuracy. Please refer to [reference needed]. Figure 6 As shown, Figure 6 This is a flowchart for flow rate and capacity accuracy detection.

[0086] Step 101: Open the application software and click to enter the flow accuracy detection interface. The application software has multiple functions. Enter the corresponding interface according to the detection function.

[0087] Step 102: Set the required flow rate values ​​on the interface, such as 1L / S, 3L / S, 6L / S, 9L / S, 12L / S, 15L / S, 18L / S, etc.

[0088] Step 103: Set the air chamber volume value, such as 2L, 5L, 10L, etc.

[0089] Step 104: Select the type of test (exhalation or inhalation). Exhalation involves pushing the lever in the air chamber towards the air inlet, causing the gas inside the air chamber to exit through the air inlet. Inhalation involves pulling the lever inward, causing air to enter the air chamber through the air inlet. These are used to test the accuracy of expiratory flow rate or inspiratory flow rate, respectively.

[0090] Steps 105, 106, and 107: Based on the user's test parameter settings, prepare all components of the control and testing device, the most important of which is to complete the capacity setting and flow rate setting.

[0091] Steps 108, 109, and 110: Start the test and complete the gas output with the set flow rate and volume. The gas enters the flow sensor of the pulmonary function instrument through the air inlet.

[0092] Steps 111 and 112 involve obtaining real-time flow data from the pulmonary function instrument and standard flow data from the detection device, and then performing calculations to obtain the required flow accuracy.

[0093] This embodiment of the slow vital capacity (SVC) detection implementation scheme involves testing the SVC measurement function performance of a pulmonary function instrument, such as... Figure 8 As shown.

[0094] The flowchart for chronic lung capacity testing is as follows: Figure 7 As shown, the respiratory process consists of four steps: tidal breathing, forced inhalation, complete exhalation, and end-expiratory breathing. The lung capacity indicators that can be measured by the slow vital capacity function of the pulmonary function instrument include tidal volume (VT), expiratory vital capacity (EVC), inspiratory reserve volume (IRV), expiratory reserve volume (ERV), and inspiratory capacity (IC).

[0095] To implement this, open the application software and click to enter the chronic lung capacity test interface.

[0096] Steps 302, 303, and 304 involve setting the tidal volume (VT), inspiratory reserve volume (IRV), and expiratory reserve volume (ERV) values ​​on the interface. Since expiratory lung volume (EVC) = IRV + VT + ERV and inspiratory volume (IC) = VT + IRV, these two parameters are automatically calculated and do not require user setting. After setting the lung volume parameters, as shown... Figure 8 The corresponding slow vital capacity breathing waveform is generated as shown.

[0097] Steps 305, 306, and 307: Click "Test Preparation"; The computer sends the slow vital capacity breathing waveform data and lung volume parameters to the main processor, and the main processor controls the initial volume of the air chamber to be the expiratory volume supplement (ERV).

[0098] In steps 308, 309, and 310, click "Start Test" on the function interface. The main processor controls the lung ventilation module of the testing device to output a respiratory waveform based on the slow vital capacity (SVC) respiratory waveform data. The pulmonary function instrument measures the SVC respiratory waveform output by the testing device in real time and calculates the lung volume parameter value. By comparing the lung volume parameter value with the standard value of the testing device, the accuracy of the lung volume parameter obtained by the pulmonary function instrument from the SVC measurement can be calculated.

[0099] The forced vital capacity (FVC) detection scheme in this embodiment is to test the performance of the forced vital capacity measurement function of a large pulmonary function instrument.

[0100] The waveform of forced vital capacity is as follows: Figure 9As shown, the breathing patterns are: 401 Tidal breathing: even and calm breathing; 402 Maximum end-expiratory breathing: deep exhalation to total lung capacity at the end of tidal inspiration; 403 Rapid inspiration; and 404 Rapid exhalation. This function can measure peak flow rate (PEF), forced expiratory flow rate (FEF25), forced expiratory flow rate (FEF50), and forced expiratory volume in one second (FEV1), and forced expiratory volume in one second (FVC).

[0101] The implementation method is basically the same as that for slow vital capacity. First, the parameters are changed to forced vital capacity parameters, and the computer application software generates based on the parameters. Figure 9 The forced vital capacity (FVC) breathing waveform shown is sent to the main processor. The user first clicks "Test Preparation" to set the initial volume of the air chamber to the expiratory volume supplement (ERV), and then clicks "Start Test." The main processor controls the detection device to output the FVC breathing waveform, and the pulmonary function instrument performs real-time measurement and calculates the FVC parameter value.

[0102] The lung diffusion function testing scheme in this embodiment is as follows: Figure 10 As shown, 501 is a respiratory gas volume-time graph, 502 is a tracer gas concentration-time graph, and the tracer gas used in this embodiment is methane (CH4), and 503 is a carbon monoxide gas concentration-time graph.

[0103] Lung diffusion capacity refers to the ability of a certain alveolar gas to diffuse through the alveolar membrane from the alveoli into the capillaries and into the bloodstream, where it binds to hemoglobin in red blood cells. Lung diffusion capacity testing measures indicators of the gas exchange process of oxygen and carbon dioxide through the alveolar and pulmonary capillary walls within the lungs. Currently, the following methods and procedures are commonly used to test lung diffusion capacity: 1. Quiet breathing: The subject wears a nose clip, holds a mouthpiece, and breathes quietly for 4-5 cycles. 2. Complete exhalation: After the end-tidal baseline stabilizes, the subject continues exhaling until the residual volume is reached. 3. Rapid inspiration: Rapid and even inspiration to the total lung capacity (ideally within 2 seconds; for those with airway obstruction, within 4 seconds). 4. Breath-holding: Breath-holding for approximately 10 seconds. 5. Moderate and steady exhalation: Even and sustained moderate-speed exhalation to the residual volume (ideally within 2-4 seconds). The data obtained in these steps are then calculated using the DLCO (Lung Carbon Monoxide Diffusion Capacity) formula. Without considering correction factors for hemoglobin and altitude, the formula for calculating DLCO using traditional units (mL(STPD)·min⁻¹·mmHg⁻¹) is as follows:

[0104]

[0105] Among them, v ASTPDThe value represents the alveolar volume under STPD conditions, (VI - physiological dead space - systemic dead space) * FICH4 / FACH4; the physiological dead space is 150 ml (not applicable to children) or calculated by the formula 2.2 ml * weight (kg) (not applicable to obese individuals), and the systemic dead space is a fixed value that can be measured according to the structure of the diffusion pulmonary function instrument.

[0106] t BH This indicates the breath-holding time, measured in seconds (s).

[0107] p B This represents atmospheric pressure, expressed in mmHg.

[0108] 47 represents the water vapor pressure at 37 degrees Celsius, expressed in mmHg.

[0109] F ICO This indicates the concentration of CO in the inhaled gas;

[0110] F ACH4 This indicates the concentration of CH4 in exhaled breath;

[0111] F ICH4 Indicates the concentration of CH4 in the inhaled air;

[0112] F ACO This indicates the concentration of CO in exhaled breath;

[0113] The above method uses carbon monoxide to test lung diffusion capacity. In order to calculate the carbon monoxide diffusion capacity, it is necessary to measure the alveolar carbon monoxide concentration at the start of diffusion and after breath-holding, as well as the alveolar volume.

[0114] The pulmonary diffusion breathing procedure is divided into 701 forced inhalation phases. During this phase, the air chamber tracheal passage is open, and the detection device controls the air chamber to receive a mixed standard gas output from the pulmonary function instrument. The standard gas concentration is 0.3% for both methane and carbon monoxide. The 0.3% mixed gas enters the air chamber. After inhaling to the set value, the air chamber tracheal passage is closed.

[0115] During the 702 breath-hold phase, all tracheal pathways of the pulmonary function instrument in both the air chamber and the mixed-gas chamber are kept closed, forming a sealed space. This process simulates the diffusion process in the human lungs. The breath-hold phase lasts for 10 seconds.

[0116] Entering the 703 complete exhalation phase, the endotracheal passage to the mixing chamber is opened, and the detection device outputs the pre-stored gas mixture to the pulmonary function analyzer. This gas mixture is prepared before the test begins, with a concentration below 0.3%. Figure 10 502 Methane gas concentration-time curve, 503 Carbon monoxide gas concentration-time curve.

[0117] After completing the above three stages, the pulmonary function instrument can obtain the lung diffusion breathing waveform data output by the detection device in real time through its equipped flow sensor and gas concentration detection sensor, thereby obtaining lung diffusion indicators such as DLCO carbon monoxide diffusion amount and VA alveolar volume.

[0118] like Figure 10 The diagram shows the lung diffusion detection flowchart. Users can open the application software on their computer, click to enter the diffusion detection function interface 601, and then start the relevant operations for lung diffusion detection.

[0119] First, set the relevant parameters 602 for the diffusion breathing waveform. The parameters that need to be set are DLCO (carbon monoxide diffusion) and VA (alveolar volume) to generate lung diffusion breathing waveform data 603.

[0120] To prepare for the test, click Test Preparation 604. At this time, the computer sends diffusion breathing waveform data to the main processor. Because the lung diffusion function requires the lung ventilation module and the mixed gas output module to complete the diffusion detection through the cooperation of the two modules, the initial volume values ​​of the air chamber and the mixed gas chamber 605 and 606 need to be set according to the breathing waveform data.

[0121] Click to start test 607, control the detection device to output diffusion breathing waveform 608. The basic control algorithm controls according to the breathing steps, which are divided into three steps: first, control the air chamber to inhale standard gas, then close all tracheal passages to enter the breath-holding stage, and finally open the output passage of the mixing chamber to control the output of gas in the mixing chamber, thus completing the output of the entire lung diffusion breathing waveform.

[0122] The lung diffusion function of a large pulmonary function instrument detects the lung diffusion respiratory waveform output by the detection device in real time, obtains respiratory data, and can calculate diffusion parameter indicators. By comparing these parameters with the standard parameters of the detection device, the detection performance of the lung diffusion function of the large pulmonary function instrument can be understood.

[0123] The pulmonary function instrument testing system and testing device of the present invention provide a complete and scientific testing system for testing pulmonary ventilation function, pulmonary diffusion function and pressure difference, solving the problem of difficult performance evaluation of large pulmonary function instruments, and providing assistance for the design, development, comprehensive performance improvement and standardization of large pulmonary function instruments.

[0124] The above description is merely an embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A testing system for a pulmonary function instrument, used for testing pulmonary function instruments, characterized in that, The testing system includes a differential pressure sampling module, a lung function testing module, a main processor, and a terminal. The differential pressure sampling module is connected to the pulmonary function instrument and is used to collect differential pressure data from the flow sensor in the pulmonary function instrument and send the differential pressure data to the main processor. The lung function testing module is connected to the lung function instrument and is used to simulate the breathing process according to the instructions of the main processor and send the test data to the main processor. The main processor is used to receive instructions from the terminal, control the operation of the differential pressure sampling module and the lung function detection module according to the instructions, collect and calculate the differential pressure data of the differential pressure sampling module and the lung function detection data of the lung function detection module, and send the differential pressure data and the lung function detection data to the terminal. The terminal is used to send instructions containing test parameters to the main processor, and to store the differential pressure data and lung function test data returned by the main processor; The lung function testing module includes a lung ventilation function testing module and a lung diffusion function testing module. The lung ventilation function testing module is used to simulate the lung ventilation testing process, and the lung diffusion function testing module is used to simulate the lung diffusion testing process. The pulmonary function instrument is a large-scale pulmonary function instrument; The lung ventilation function detection module includes an air chamber, a first control module, a first valve control unit, and several first solenoid valves; The air chamber is used to provide the pulmonary function instrument with test gas for pulmonary ventilation function testing; The first control module is used to control the opening and closing of the air chamber; The first valve control unit is used to control the opening and closing of a plurality of the first solenoid valves; The lung diffusion function detection module includes a gas mixing chamber, a second control module, a multi-concentration gas mixing device, and a gas calibration module. The gas mixing chamber is used to provide the pulmonary function instrument with test gas for lung diffusion function detection; The second control module is used to control the opening and closing of the gas mixing chamber; The multi-concentration gas mixing device is used to prepare the gas with the required components for the test gas of the lung diffusion function detection. The gas calibration module is used to detect and calibrate the composition of the test gas for the lung diffusion function test; The gas calibration module includes multiple gas cylinders, a gas chamber, a solenoid valve group, and a second valve control unit. The plurality of gas cylinders are all connected to the gas chamber via pipelines; The gas chamber is used to mix the gases stored in the plurality of gas cylinders; The second valve control unit is used to control the opening and closing of the solenoid valve group and the pipeline in which the solenoid valve group is located.

2. The testing system for a pulmonary function instrument according to claim 1, characterized in that, Both the first control module and the second control module include a grating displacement sensor and a linear motor; Both the air chamber and the mixed gas chamber include a pull rod, the linear motor is used to drive the pull rod to reciprocate, and the grating displacement sensor is used to detect the displacement of the pull rod.

3. The pulmonary function testing system according to claim 2, characterized in that, Both the lung ventilation function detection module and the lung diffusion function detection module also include a humidification and heating unit and a temperature and humidity sensor. The humidification and heating unit is used to heat and humidify the gas in the air chamber and the mixed gas chamber; The temperature and humidity sensor is used to detect the temperature and humidity of the gas in the air chamber and the mixed gas chamber.

4. The testing system for a pulmonary function instrument according to claim 1, characterized in that, The differential pressure sampling module includes a differential pressure sensor and a differential pressure signal processing unit. The differential pressure sensor is electrically connected to the flow sensor of the pulmonary function instrument and is used to detect the differential pressure data of the flow sensor. The differential pressure signal processing unit is electrically connected to the differential pressure sensor and is used to receive the differential pressure data measured by the differential pressure sensor, convert and process it, and then send it to the main processor.

5. The testing system for a pulmonary function instrument according to claim 4, characterized in that, The differential pressure sensor includes a first differential pressure sensor and a second differential pressure sensor. The range of the first differential pressure sensor is 0 to ±250 Pa, and the range of the second differential pressure sensor is 0 to ±1.5 kPa. The differential pressure sampling module also includes a valve control module, which is used to switch the opening and closing of the first differential pressure sensor and the second differential pressure sensor.

Images