Breath tester and method of using the same

Abstract

The present invention discloses a breath tester, comprising: a breath collection and pre-processing module, an ambient gas pre-processing module and a sensor detection module. In the breath collection and pre-processing module, the collection unit comprises a breath pre-processing filter membrane, a carbon dioxide sensor and a gas sampling bag sequentially placed in the breath pipeline behind the blowing port, the pre-processing unit comprises a detection gas pre-processing filter membrane and a detection gas refrigeration module sequentially placed in the detection gas pipeline; the ambient gas pre-processing module comprises an ambient gas pre-processing filter membrane and an ambient gas refrigeration module sequentially arranged in the ambient gas pipeline; the sensor detection module comprises a first control valve, a detection pump body, a gas sensor, and a detection gas and ambient temperature, humidity and pressure sensor. The breath tester and its use method avoid pre-processing trace components in the exhaled breath by concentrating, enriching and then desorbing, which is simple and convenient, while retaining the original state of the exhaled breath, which is conducive to improving the accuracy of gas identification.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more specifically, to a breath tester and a method for using the same. Background Art

[0002] Exhaled breath contains trace amounts of volatile compounds that are closely related to human metabolism or the metabolism of the internal flora, and can comprehensively measure a person's physical condition. Compared with traditional biochemical tests, such as blood tests, urine tests, imaging tests, tissue sections, etc., exhaled breath testing has great advantages in the fields of personal health management and disease screening. Exhaled breath testing is a completely non-invasive testing method with great advantages in testing frequency, sample acquisition, and testing costs.

[0003] The existing gold standard for exhaled breath testing is a detection method based on the GC-MS platform. Due to its large equipment and complex operation and analysis, it needs to be operated by professionals and is not suitable for widespread use in clinical practice, let alone home use.

[0004] The characteristic markers related to the course of the disease in exhaled breath include inorganic volatile gases and organic volatile compounds, and their concentrations are usually in the range of ppt to ppm (10 -12 ~10 -6 ) levels, in order to facilitate detection, currently, concentration and enrichment methods are usually used to increase the concentration of target molecules. For example, VOCs (volatile organic compounds) in exhaled breath are collected by enrichment and then detected by GC-MS. However, a large number of disease-related molecules are usually lost during the concentration / enrichment process, especially inorganic volatile markers. In addition, desorption after enrichment and concentration, and then testing and analysis, is time-consuming and not conducive to rapid diagnosis screening / feedback results.

[0005] Existing online detection methods such as SIFT-MS, PTR-MS, etc. can achieve real-time online detection, but they are costly and it is difficult to measure inorganic volatile gases.

[0006] In summary, how to effectively solve the problem of losing disease-related molecules during the concentration / enrichment process of the breath tester, thereby affecting the test results, is a problem that technical personnel in this field need to solve. Summary of the invention

[0007] In view of this, an object of the present invention is to provide a breath tester, the structural design of which can effectively solve the problem of losing disease-related molecules during the concentration / enrichment process of the breath tester, thereby affecting the test results.

[0008] In order to achieve the above object, the present invention provides the following technical solutions:

[0009] A breathalyzer comprising:

[0010] The exhaled air collection and pre-processing module comprises an exhaled air collection unit and an exhaled air pre-processing unit, wherein the exhaled air collection unit comprises an exhaled air pre-processing filter membrane and a carbon dioxide sensor sequentially placed in an exhaled air pipeline; the exhaled air pre-processing unit comprises a detection gas pre-processing filter membrane placed in a detection gas pipeline and a detection gas refrigeration module for cooling the detection gas;

[0011] An ambient air pre-treatment module, comprising an ambient air pre-treatment filter membrane sequentially arranged in an ambient air pipeline and an ambient air refrigeration module for cooling the ambient air;

[0012] The sensor detection module includes a first control valve, a detection pump body and a gas sensor connected in sequence, wherein the first inlet of the first control valve is connected to the air outlet of the exhalation collection and pre-processing module through a detection air temperature, humidity and pressure sensor, the second inlet is connected to the air outlet of the ambient air pre-processing module through an ambient air temperature, humidity and pressure sensor, and the outlet of the first control valve is connected to the detection pump body.

[0013] Preferably, in the above-mentioned breath tester, the pre-exhalation treatment filter membrane and the carbon dioxide sensor are arranged in sequence behind the blowing port, and the exhalation collection unit also includes an exhalation one-way valve connected to the rear of the pre-exhalation treatment filter membrane and a gas sampling bag connected to the rear of the carbon dioxide sensor.

[0014] Preferably, in the above-mentioned breath tester, the breath collection unit also includes a breath cooling module.

[0015] Preferably, in the above-mentioned breath tester, the exhaled air cooling module further comprises a condensate collector connected to the exhaled air pipeline, and the condensate can be used for chromatographic or mass spectrometric detection of the exhaled air.

[0016] Preferably, in the above-mentioned breath tester, the breath collection unit also includes an air inlet valve, the air inlet end of the air inlet valve is connected to the air outlet of the carbon dioxide sensor, the first air outlet end of the air inlet valve is connected to the air inlet of the gas sampling bag, and the second air outlet end is connected to the outside world.

[0017] Preferably, in the above-mentioned breath tester, a cleaning pump body for cleaning the breath pipeline is provided at the connection point between the carbon dioxide sensor and the air inlet valve, and a filter membrane is provided at the air inlet end of the cleaning pump body.

[0018] Preferably, in the above-mentioned breath tester, the breath collection unit further comprises a flow sensor or a flow velocity sensor arranged in the breath pipeline behind the breath pre-treatment filter membrane.

[0019] Preferably, in the above-mentioned breath tester, in the breath collection and pre-processing module, the breath collection unit can be independent of the breath pre-processing unit, and the gas sampling bag can be detachably connected to the breath circuit. In the online test mode, the breath collection unit is connected to the breath pre-processing unit through the gas sampling bag; in the offline test mode, the breath collection unit collects the breath to obtain a gas sampling bag, and during detection, the gas sampling bag is connected to the front of the detection gas pre-treatment filter membrane for detection.

[0020] Preferably, in the above-mentioned breath tester, the pre-exhalation processing unit is provided with a visual module for reading relevant information on the gas sampling bag.

[0021] Preferably, in the above-mentioned breath tester, the sensor detection module also includes a detection gas filter membrane arranged in front of the air inlet of the detection temperature, humidity and pressure sensor and an ambient air filter membrane arranged in front of the air inlet of the ambient temperature, humidity and pressure sensor; the detection gas filter membrane is connected to the air outlet end of the exhalation pre-treatment unit, and the ambient air filter membrane is connected to the air outlet end of the ambient air pre-treatment module.

[0022] Preferably, in the above breath tester, the sensor detection module further comprises a second control valve for switching the outlet of the first control valve to communicate with the outside or with the gas sensor.

[0023] Preferably, the above-mentioned breath tester also includes a power supply module for power supply, a microcomputer control interaction module for control and a display module for output.

[0024] When the breath tester provided by the present invention is used, the exhaled air is filtered through the exhaled pre-treatment filter membrane to remove part of the water vapor and filter bacteria; the segmented exhaled air to be tested is selectively extracted through the carbon dioxide sensor, and if the blown gas does not meet the collection requirements, it is emptied, and if it meets the requirements, subsequent testing is performed. The exhaled air is cooled by the refrigeration module to remove the water vapor in the exhaled air, so that its humidity is the same as the ambient air. Since the humidity in the exhaled air of the human body is close to %, the humidity has a significant effect on gas detection, and it may drown the response of the gas sensor to the trace trace components in the exhaled air. Therefore, by cooling and dehumidifying, the exhaled air is reduced to a relatively low temperature, and its humidity decreases accordingly, and finally can be reduced to the humidity corresponding to the saturated vapor pressure at this temperature, thereby reducing the interference of humidity on the test. And the pre-treatment of the gas is achieved by cooling, which retains more trace trace components in the exhaled air. The exhaled air after pre-treatment enters the gas sensor under the action of the detection pump body for corresponding detection. In addition, the present invention adds an ambient gas pretreatment module to collect ambient gas at the time of exhalation during the test, thereby eliminating the influence of trace and trace components in the ambient gas on the detection. In summary, the breath tester provided by the present invention avoids pretreatment of trace and trace components in the exhaled gas by means of concentration and enrichment and then desorption and desorption, which is simple, convenient, and time-saving, while retaining the original state of the exhaled gas. The test components can contain trace inorganic and organic volatile components, which is conducive to improving the accuracy of gas identification.

[0025] The present invention also provides a method for using a breath tester, which is used for any of the above breath testers and has two modes: an online test mode and an offline test mode, including:

[0026] Step 1: The exhaled air from the blowing port passes through the exhaled air collection unit, the exhaled air pre-treatment filter membrane, and the carbon dioxide sensor to reach the gas sampling bag. In the online test mode, the exhaled air collection unit is directly connected to the exhaled air pre-treatment unit via the gas sampling bag; in the offline mode, after the gas sampling bag completes the collection, it is transported to the test site and connected to the front end of the detection gas pipeline of the exhaled air pre-treatment unit;

[0027] Step 2: After the ambient gas passes through the ambient gas pre-treatment filter membrane and the ambient gas refrigeration module, it flows through the ambient air temperature, humidity and pressure sensor to detect and record the temperature, humidity and pressure of the ambient gas, and then is pumped into the gas sensor by the detection pump body through the first control valve for baseline collection;

[0028] Step 3: When the detection pump body and the gas sensor are working continuously, switch the first control valve to switch the ambient gas to the detection gas. The detection gas passes through the detection gas pre-treatment filter membrane and the detection gas refrigeration module and flows through the detection air temperature, humidity and pressure sensor to detect the temperature, humidity and pressure of the detection gas. The test results of the detection air temperature, humidity and pressure sensor are compared with those of the ambient air temperature, humidity and pressure sensor. If they meet the preset difference range, the detection gas flows through the first control valve and is pumped into the gas sensor for detection. Otherwise, the exhalation pre-treatment fails, the detection is stopped, and the cleaning state is entered.

[0029] Step 4: After the breath test, while the detection pump and the gas sensor are working continuously, the first control valve is switched again to introduce ambient gas so that the gas sensor returns to an initial state, thereby completing a test.

[0030] The method for using the breath tester provided by the present invention avoids pre-treatment of trace components in the exhaled breath by means of concentration and enrichment followed by desorption and desorption, which is simple, convenient, and time-saving, while retaining the original state of the exhaled breath. The test components can contain trace inorganic and organic volatile components, which is beneficial to improving the accuracy of gas identification.

[0031] The breathalyzer and the method of using the same provided by the present invention can be used for online real-time testing of exhaled breath, and can also be used for offline testing; the integration of multiple sensors, such as flow or velocity sensors, carbon dioxide sensors, gas sensors, etc., provides a multi-dimensional characterization method for exhaled breath; the modular combination form facilitates structural combination, maintenance, and multi-scenario application; the pretreatment of the gas is achieved by cooling, avoiding the pretreatment of trace components in the exhaled breath by concentration, enrichment, and then desorption and desorption, which is simple, convenient, and time-saving, and more trace components in the exhaled breath are retained, while retaining the original state of the exhaled breath. The test components contain trace amounts of inorganic and organic volatile components, which is beneficial to improving the accuracy of gas identification; the measured response kinetic curve takes the current ambient air as the baseline, directly deducts the influence of background gas on breath detection, enhances the direct correlation of the breath signal, and improves the accuracy of test and identification; in addition, after the exhaled breath is collected, the gas pretreatment is completed in the instrument, and the exhaled breath condensate can be collected at the same time, and then multiple test methods of exhaled breath detection can be carried out: sensor testing of low molecular weight gases, and mass spectrometry detection of slightly higher molecular weight in the condensate, which can cover more gas detection components and improve the accuracy of test identification. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0033] Figure 1 A schematic diagram of a breath collection unit in a breath tester according to a specific embodiment of the present invention;

[0034] Figure 2 The figure is a schematic diagram of a breath tester according to a specific embodiment of the present invention.

[0035] The following are marked in the accompanying drawings:

[0036] Breath collection unit 1, breath pre-processing unit 2, ambient air pre-processing module 3, sensor detection module 4;

[0037] Exhalation pre-treatment filter membrane 101, exhalation one-way valve 102, exhalation refrigeration module 103, condensate collector 104, flow rate sensor 105, carbon dioxide sensor 106, cleaning pump body 107, filter membrane 108, air inlet valve 109, gas sampling bag 110;

[0038] Vision module 201, detection gas pre-treatment filter membrane 202, detection gas refrigeration module 203;

[0039] Ambient air pre-treatment filter membrane 301, ambient air refrigeration module 302;

[0040] Detection gas filter membrane 401, detection temperature, humidity and pressure sensor 402, first control valve 403, detection pump body 404, second control valve 405, gas sensor 406, environmental gas filter membrane 407, environmental temperature, humidity and pressure sensor 408. DETAILED DESCRIPTION

[0041] The embodiment of the present invention discloses a breath tester to avoid pre-processing trace components in exhaled breath by means of concentration, enrichment, desorption and desorption.

[0042] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] See also Figure 1 , Figure 1The figure is a schematic diagram of a breath collection unit in a breath tester according to a specific embodiment of the present invention.

[0044] In a specific embodiment, the breath tester provided by the present invention comprises a breath collection and pre-processing module, an ambient air pre-processing module 3 and a sensor detection module 4. The breath collection and pre-processing module comprises a breath collection unit 1 and a breath pre-processing unit 2.

[0045] Among them, the exhaled air collection unit 1 includes an exhaled air pre-treatment filter membrane 101 and a carbon dioxide sensor 106 arranged in the exhaled air circuit. The exhaled air pre-treatment filter membrane 101 can specifically adopt a conventional waterproof breathable membrane or filter membrane, which is not specifically limited here. The carbon dioxide sensor 106 is used to selectively extract the segmented exhaled air to be detected. If the blowing does not meet the requirements or is the dead space gas of the exhaled air, the carbon dioxide concentration is usually less than the preset value, such as less than 4.5%. The value here can be adjusted according to the actual exhaled air segment to be collected. For example, when collecting alveolar gas, the preset value is 5.3%. When the carbon dioxide concentration detected by the carbon dioxide sensor 106 is greater than the corresponding preset value, the collected exhaled air meets the collection requirements, otherwise it does not meet the collection requirements.

[0046] Furthermore, the exhaled air collection unit 1 further comprises an exhaled air one-way valve 102 connected to the rear of the exhaled air pre-treatment filter membrane 101 and a gas sampling bag 110 connected to the rear of the carbon dioxide sensor 106. The exhaled air one-way valve 102 is provided to ensure the direction of the exhaled air flow.

[0047] Specifically, the exhaled air collection unit 1 also includes an exhaled air refrigeration module 103, which is used to cool and dehumidify the exhaled air pipeline, so that the carbon dioxide content in the exhaled air entering the carbon dioxide sensor 106 for detection is more accurate and reliable. The specific structure of the exhaled air refrigeration module 103 can refer to the conventional refrigeration structure in the prior art, and is not specifically limited here. The exhaled air refrigeration module 103 also includes a condensate collector 104 connected to the exhaled air pipeline. The collected condensate can be used for other detection methods, such as mass spectrometry detection, that is, the exhaled air condensate can be used for mass spectrometry detection. Generally speaking, the characteristic molecules in the exhaled air condensate are VOCs, and the uncondensed components in the gas sampling bag 110 contain inorganic and organic volatile substances with relatively small molecular weights. Combined with the condensate detection, the detection molecular weight segment can be expanded and the gas identification dimension can be improved.

[0048] Specifically, the breath collection unit 1 also includes an air inlet valve 109, the air inlet end of the air inlet valve 109 is connected to the air outlet of the carbon dioxide sensor 106, the first air outlet end of the air inlet valve 109 is connected to the air inlet of the gas sampling bag 110, and the second air outlet end is connected to the outside world. The air inlet valve 109 is used to switch the air outlet of the carbon dioxide sensor 106 to the gas sampling bag 110 or to the outside world. The air inlet valve 109 can be specifically a three-way valve, such as a three-way solenoid valve, the inlet of the three-way valve is connected to the air outlet of the carbon dioxide sensor 106, the first outlet of the three-way valve is connected to the gas sampling bag 110, and the second outlet of the three-way valve is connected to the outside world. By changing the position of the valve core, the inlet is switched to be connected to the first outlet or the second outlet. As needed, the air inlet valve 109 can also use two solenoid valves respectively arranged between the carbon dioxide sensor 106 and the gas sampling bag 110 and between the carbon dioxide sensor 106 and the outside world.

[0049] Furthermore, the breath collection unit 1 also includes a cleaning pump body 107 disposed at the connection point between the carbon dioxide sensor 106 and the air inlet valve 109 for cleaning the breath pipeline, and a filter membrane 108 is disposed at the air inlet end of the pump body.

[0050] Furthermore, the exhaled air collection unit 1 also includes a flow sensor or a flow rate sensor 105 disposed in the exhaled air circuit behind the exhaled air pre-treatment filter membrane 101. In the exhaled air test in different scenarios, the lung function condition affects the disease state test, so the flow sensor or the flow rate sensor 105 is provided to perform a corresponding evaluation of the lung function.

[0051] Please also read Figure 2 , Figure 2 The figure is a schematic diagram of a breath tester according to a specific embodiment of the present invention.

[0052] by Figure 1 and Figure 2 Taking the breath tester shown as an example, in a specific embodiment, the breath tester provided by the present invention includes a breath collection and pre-processing module, an ambient air pre-processing module and a sensor detection module.

[0053] In the exhaled air collection and pre-processing module, the exhaled air collection unit 1 includes an exhaled air pre-processing filter membrane 101 and a carbon dioxide sensor 106 which are sequentially placed in the exhaled air pipeline; the exhaled air pre-processing unit 2 includes a detection gas pre-processing filter membrane 202 placed in the detection gas pipeline and a detection gas refrigeration module 203 for cooling the detection gas.

[0054] The ambient air pre-treatment module 3 comprises an ambient air pre-treatment filter membrane 301 arranged in the ambient air pipeline and an ambient air refrigeration module 302 for cooling the ambient air.

[0055] Specifically, the ambient air passes through the ambient air pre-treatment filter membrane 301 to remove dust and bacteria in the air, and then flows through the ambient air refrigeration module 302 through the pipeline channel and enters the sensor detection module. The ambient air refrigeration module 302 can be used together with the detection air refrigeration module 203.

[0056] The sensor detection module 4 includes a first control valve 403, a detection pump body 404 and a gas sensor 406 connected in sequence. The first inlet of the first control valve 403 is connected to the outlet of the exhaled gas collection and pre-processing module through the detection temperature, humidity and pressure sensor 402, and the second inlet is connected to the outlet of the ambient gas pre-processing module through the ambient temperature, humidity and pressure sensor 407. The outlet of the first control valve 403 is connected to the detection pump body 404. That is, in the sensor detection module, the ambient gas and the exhaled gas to be tested are pumped into the gas sensor 406 from two independent pipelines through the first control valve 403 and the detection pump body 404 for detection. In the detection, the deduction of background gas directly affects the detection accuracy and reliability. In the design of the breath detector of the present invention, an ambient gas pre-processing module is added to collect the ambient gas at the time of exhalation during the test, and eliminate the influence of trace and micro components in the ambient gas on the detection. For the online detection mode, the whole process of ambient gas collection and exhaled breath collection is kept at the same time and place; for the offline detection mode, in order to ensure the accuracy of the test, the ambient gas baseline should be collected at the same place and similar time as much as possible, provided that there is no big difference in the composition of ambient air and exhaled breath. The gas sensor 406 can be a multi-channel sensor to perform multiple tests at the same time. The detection pump body 404 can be a micro air pump.

[0057] The first control valve 403 may be a three-way valve, such as a three-way solenoid valve, which realizes the connection between the first inlet and the outlet, or the connection between the second inlet and the outlet by changing the position of the valve core. As needed, the first control valve 403 may also use two solenoid valves respectively arranged between the detection temperature, humidity and pressure sensor 402 and the gas sensor 406 and between the ambient temperature, humidity and pressure sensor 407 and the gas sensor 406, and realizes the switching by turning on and off the two solenoid valves.

[0058] When the breath tester provided by the present invention is used, part of the water vapor and filter bacteria of the exhaled air are removed by the exhaled pre-treatment filter membrane; the segmented exhaled air to be tested is selectively extracted by the carbon dioxide sensor, and if the blown gas does not meet the collection requirements, it is emptied, and if it meets the collection requirements, subsequent testing is performed. The cavity is cooled by the exhaled refrigeration module, so as to remove the water vapor of the exhaled air in the sampling bag, so that its humidity is the same as that of the ambient air. Since the humidity in the exhaled air of the human body is close to 100%, the humidity has a significant effect on gas detection, which may drown the response of the gas sensor to the trace trace components in the exhaled air. Therefore, by cooling and dehumidifying, the exhaled air is reduced to a relatively low temperature, such as 0°C, and its humidity is reduced accordingly, and finally it can be reduced to the humidity corresponding to the saturated vapor pressure at this temperature, thereby reducing the interference of humidity on the test. And the pre-treatment of the gas is achieved by cooling, and more trace trace components in the exhaled air are retained. The exhaled air after pre-treatment enters the gas sensor under the action of the detection pump body for corresponding detection. In addition, the present invention adds an ambient gas pretreatment module to collect ambient gas at the time of exhalation during the test, thereby eliminating the influence of trace and trace components in the ambient gas on the detection. In summary, the breath tester provided by the present invention avoids pretreatment of trace and trace components in the exhaled gas by means of concentration and enrichment and then desorption and desorption, which is simple, convenient, and time-saving, while retaining the original state of the exhaled gas. The test components can contain trace inorganic and organic volatile components, which is conducive to improving the accuracy of gas identification.

[0059] In the above embodiment, the breath tester can be used for online testing on the one hand, and can be used for offline testing on the other hand. Specifically, the breath collection unit 1 can be independent of the breath pre-processing unit 2, and the gas sampling bag 110 in the breath collection unit can be detachably connected to the breath pre-processing unit 2.

[0060] The gas sampling bag 110 can be specifically a double-valve gas sampling bag. In the online test mode, the air inlet valve of the double-valve gas sampling bag is connected to the exhalation pipeline of the exhalation collection module, and the air outlet valve of the double-valve gas sampling bag is connected to the detection gas pipeline of the exhalation pre-treatment unit 2. The exhaled gas enters from the blowing port, passes through the exhalation pre-treatment filter membrane 101 and the carbon dioxide sensor 106 in turn, and enters the gas sampling bag 110 if it meets the collection requirements, and then performs subsequent detection.

[0061] The gas sampling bag 110 can specifically be a single-valve gas sampling bag. In the offline detection mode, the single-valve gas sampling bag is first connected to the end of the exhalation pipeline of the exhalation collection module to collect the exhaled air to be tested; after the collection is completed, the single-valve gas sampling bag 110 is disassembled; then, it is transported to the detection site and connected to the front end of the gas pipeline to be tested of the exhalation pre-treatment unit 2 to complete the test. This method is particularly suitable for sample collection in special occasions to avoid cross-infection between people. It is not difficult to understand that under special working conditions, exhaled air collection can also be completed according to the standard collection process SOP, directly exhaling the gas into the single-valve gas sampling bag, and then conducting subsequent tests.

[0062] In the above embodiment, the front end of the exhalation pre-processing unit 2 is provided with a visual module 201 for reading relevant information on the gas sampling bag 110. The relevant information includes sample information encoded on the gas sampling bag 110, inflation status, etc. For the specific structure and working principle of the visual module 108, please refer to the prior art and will not be repeated here.

[0063] Specifically, the sensor detection module 4 includes a detection gas filter membrane 401, an exhaled air temperature, humidity and pressure sensor 402, and an ambient air filter membrane 407 and an ambient air temperature, humidity and pressure sensor 408, which are arranged in sequence; the detection gas filter membrane 401 is connected to the outlet of the exhaled air pre-processing unit 2 through the test air pipeline of the detection gas refrigeration module 203, and the ambient air filter membrane 402 is connected to the outlet of the ambient air pre-processing module through the pipeline where the ambient air refrigeration module 302 is located. The materials of the detection gas filter membrane 401, the ambient air filter membrane 407, the exhaled air pre-processing filter membrane 202 and the ambient air pre-processing filter membrane 203 can be the same or different.

[0064] Furthermore, the sensor detection module 4 also includes a second control valve 405 for switching the outlet of the first control valve 403 to be connected to the outside world or to the gas sensor 406. The test results of the exhaled air temperature, humidity and pressure sensor 402 and the ambient air temperature, humidity and pressure sensor 408 are compared, and when there is a significant difference, indicating that the pre-exhalation treatment is unqualified, the air is directly emptied through the second control valve 405, the test is stopped, and the equipment cleaning process is entered. The second control valve 405 can be specifically a three-way valve, such as a three-way solenoid valve, whose inlet is connected to the air outlet of the detection pump body 404, the first outlet of the three-way valve is connected to the outside world, and the second outlet is connected to the gas sensor 406.

[0065] The breath tester provided by the present invention may also include a power module, a microcomputer control and a display module, etc. as needed. The interactive object is the interactive panel of the breath tester or other interactive objects of the built-in instrument usage process and control. When the user uses it, he directly blows in the gas for online detection, or after blowing the gas, connects the gas sampling bag 110 to the breath pre-processing module to use the offline mode test, enters the breath tester test process, the sensor obtains a complete response curve, the data is uploaded to the server, the data is pre-processed at the back end, and the disease conditions mapped by the gas are identified through the algorithm model, and the results are finally fed back to the user.

[0066] The present invention also discloses a method for using a breath tester, which is used for any of the above breath testers, and has two modes: an online test mode and an offline test mode, including:

[0067] Step 1: The exhaled air from the blowing port passes through the exhaled pre-treatment filter membrane and the carbon dioxide sensor and reaches the gas sampling bag. In the online test mode, the exhaled air collection unit is directly connected to the detection gas pipeline of the pre-treatment unit through the gas sampling bag, waiting for the next step; in the offline test mode, after the gas sampling bag completes the collection, it is transported to the test site and connected to the front end of the detection gas pipeline of the exhaled pre-treatment unit;

[0068] Step 2: After the ambient gas passes through the ambient gas pre-treatment filter membrane and the ambient gas refrigeration module, it flows through the ambient air temperature, humidity and pressure sensor to detect and record the temperature, humidity and pressure of the ambient gas, and then is pumped into the gas sensor by the detection pump body through the first control valve for baseline collection;

[0069] Step 3: When the detection pump body and the gas sensor are working continuously, switch the first control valve to switch the ambient gas to the detection gas. The detection gas passes through the detection gas pre-treatment filter membrane and the detection gas refrigeration module, and flows through the exhaled air temperature, humidity and pressure sensor to detect the temperature, humidity and pressure of the detection gas. The test results of the detection air temperature, humidity and pressure sensor are compared with those of the ambient air temperature, humidity and pressure sensor. If they meet the preset difference range, the exhaled gas flows through the first control valve and is pumped into the gas sensor for detection. Otherwise, the exhaled air pre-treatment fails, the detection is stopped, and the cleaning state is entered.

[0070] Step 4: After the breath test, while the detection pump and the gas sensor are working continuously, the first control valve is switched again to introduce ambient gas so that the gas sensor returns to its initial state, thus completing a test.

[0071] by Figure 1 and Figure 2 Taking the breath tester shown in the figure as an example, the online test includes the following steps:

[0072] Step 1: The exhaled air from the blowing port passes through the exhaled air collection filter membrane 101 and the carbon dioxide sensor 106, and reaches the air inlet of the double-valve gas sampling bag 110. The air outlet of the double-valve gas sampling bag 110 is directly connected to the detection air pipeline of the exhaled air pre-processing module;

[0073] Step 2: The ambient gas passes through the ambient gas pre-treatment filter membrane 301 and the ambient gas refrigeration module 302, then passes through the ambient gas filter membrane 407, flows through the ambient temperature, humidity and pressure sensor 408, and the temperature, humidity and pressure of the gas are detected and recorded. The gas is then pumped into the gas sensor 406 by the detection pump body 404 through the first control valve 403 for baseline collection;

[0074] Step three: When the detection pump body 404 and the gas sensor 406 are working continuously, switch the first control valve 403 to switch the ambient gas to the detection gas. The detection gas pre-treated by the detection gas pre-treatment filter membrane 202 and the detection gas refrigeration module 203 passes through the detection gas filter membrane 401 and flows through the detection air temperature, humidity and pressure sensor 402. The temperature, humidity and pressure of the gas are detected. The test results of the detection air temperature, humidity and pressure sensor 402 are compared with those of the ambient air temperature, humidity and pressure sensor 408. If there is no significant difference, the exhaled gas flows through the first control valve 403 and is pumped into the gas sensor 406 for detection. If there is a significant difference, it indicates that the exhaled pre-treatment is unqualified, and the detection is stopped and the cleaning state is entered.

[0075] Step 4: After the breath test, while the detection pump 404 and the gas sensor 406 are working continuously, the first control valve 403 is switched again to introduce ambient gas so that the gas sensor 406 returns to its initial state, thus completing a test.

[0076] In the offline test mode, the breath collection unit 1 and the breath pre-processing unit 2 are independent of each other. The exhaled gas is collected through the breath collection filter membrane 101 and the carbon dioxide sensor 106 and reaches the gas sampling bag 110; after the gas sampling bag completes the collection, it is transported to the test site and connected to the front end of the breath pre-processing unit detection gas pipeline for subsequent testing.

[0077] In the above embodiment, the breath tester is cleaned in three cleaning units:

[0078] Process 1, cleaning the exhaled air collection pipeline: disassemble the gas sampling bag 110 and the exhaled air pipeline in front of the carbon dioxide sensor 106, the cleaning drive is issued by the cleaning pump body 107, and the ambient air enters the cleaning pump body 107 through the filter membrane 108, and respectively flows to the carbon dioxide sensor 106 to clean the front end pipeline and to the air inlet valve 109 to clean the rear end pipeline;

[0079] Process 2, cleaning the exhaled air pre-treatment and test gas detection pipeline: the cleaning drive is provided by the test pump body 404, and the air flows through the test gas pre-treatment filter membrane 202, the test gas filter membrane 401, the test temperature, humidity and pressure sensor 402, the first control valve 403, the test pump body 404, and the second control valve 405 and then is exhausted.

[0080] Process three, cleaning the environmental gas pipeline: the cleaning drive is emitted by the detection pump body 404, and the air reaches the environmental gas filter membrane 407, the environmental temperature, humidity and pressure sensor 408, the first control valve 403, the detection pump body 404, and the second control valve 405 from the environmental gas pre-treatment filter membrane 301 and then is discharged.

[0081] Inspection method for pipeline cleaning: Check that the test results of the temperature, humidity and pressure sensors 402 and the ambient temperature, humidity and pressure sensor 408 are consistent.

[0082] The various embodiments in this specification are described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the various embodiments can be referenced to each other.

[0083] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A method for using a breath tester, characterized in that: The breath tester has two modes: online test mode and offline test mode. The breath tester includes: An exhaled air collection and pre-processing module, comprising an exhaled air collection unit and an exhaled air pre-processing unit, wherein the exhaled air collection unit comprises an exhaled air pre-processing filter membrane (101) and a carbon dioxide sensor (106) which are sequentially placed in an exhaled air pipeline; the exhaled air pre-processing unit comprises a detection gas pre-processing filter membrane (202) placed in the detection gas pipeline and a detection gas cooling module (203) for cooling the detection gas to reduce humidity, the exhaled air collection unit can be independent of the exhaled air pre-processing unit, and the gas sampling bag in the exhaled air collection unit can be detached and then connected to the exhaled air pre-processing unit; An ambient air pre-treatment module, comprising an ambient air pre-treatment filter membrane (301) and an ambient air refrigeration module (302) for cooling the ambient air, which are sequentially arranged in the ambient air pipeline; A sensor detection module, comprising a first control valve (403), a detection pump body (404) and a gas sensor (406) connected in sequence, wherein a first inlet of the first control valve (403) is connected to an outlet of the breath collection and pre-processing module via a detection air temperature, humidity and pressure sensor (402), a second inlet is connected to an outlet of the ambient air pre-processing module via an ambient air temperature, humidity and pressure sensor (408), and an outlet of the first control valve (403) is connected to the detection pump body (404); The method for using the breath tester includes: Step 1: The exhaled air from the blowing port passes through the exhaled air pre-treatment filter membrane (101) and the carbon dioxide sensor (106) and reaches the gas sampling bag (110). In the online test mode, the exhaled air collection unit is directly connected to the exhaled air pre-treatment unit via the gas sampling bag (110); in the offline test mode, after the gas sampling bag (110) completes the collection, it is transported to the test site and connected to the front end of the detection gas pipeline of the exhaled air pre-treatment unit; Step 2: After the ambient gas passes through the ambient gas pre-treatment filter membrane (301) and the ambient gas refrigeration module (302), it flows through the ambient air temperature, humidity and pressure sensor (408), and the temperature, humidity and pressure of the ambient gas are detected and recorded. The ambient gas is then pumped into the gas sensor (406) by the detection pump body (404) through the first control valve (403) for baseline collection; Step three: while the detection pump body (404) and the gas sensor (406) are working continuously, the first control valve (403) is switched to switch the ambient gas to the detection gas, and the detection gas passes through the detection gas pre-treatment filter membrane (202) and the detection gas refrigeration module (203), and flows through the detection air temperature, humidity and pressure sensor (402), and the temperature, humidity and pressure of the detection gas are detected. The test results of the detection air temperature, humidity and pressure sensor (402) are compared with those of the ambient air temperature, humidity and pressure sensor (408). If they meet the preset difference range, the detection gas flows through the first control valve (403) and is pumped into the gas sensor (406) for detection. Otherwise, the exhalation pre-treatment fails, the detection is stopped, and the cleaning state is entered; Step 4: After the breath test, while the detection pump body (404) and the gas sensor (406) are in continuous operation, the first control valve (403) is switched again to allow ambient gas to flow in, so that the gas sensor (406) returns to an initial state, thereby completing a test; When cleaning the breathalyser, include: Process 1: Clean the breath collection line; Process 2: Clean the exhaled air pre-treatment and test gas detection pipeline; Process three, cleaning the environmental gas pipeline; The exhalation pre-treatment filter membrane (101) and the carbon dioxide sensor (106) are sequentially arranged behind the blowing port, and the exhalation collection unit further comprises an exhalation one-way valve (102) connected to the rear of the exhalation pre-treatment filter membrane (101) and a gas sampling bag (110) connected to the rear of the carbon dioxide sensor (106); The exhaled air collection unit further comprises an exhaled air cooling module (103), wherein the exhaled air cooling module (103) further comprises a condensate collector (104) connected to the exhaled air pipeline, wherein the condensate is used for chromatographic or mass spectrometric detection of the exhaled air; The exhaled breath collection unit further comprises an air inlet valve (109), the air inlet end of the air inlet valve (109) being connected to the air outlet of the carbon dioxide sensor (106), the first air outlet end of the air inlet valve (109) being connected to the air inlet of the gas sampling bag (110), and the second air outlet end being in communication with the outside; A cleaning pump body (107) for cleaning the exhalation pipeline is provided at the connection point between the carbon dioxide sensor (106) and the air inlet valve (109), and a filter membrane (108) is provided at the air inlet end of the cleaning pump body (107); The exhaled air collection unit further comprises a flow sensor or a flow velocity sensor (105) arranged in the exhaled air pipeline behind the exhaled air pre-treatment filter membrane (101); The exhalation pre-treatment filter membrane (101), the exhalation one-way valve (102), the exhalation refrigeration module (103), the flow sensor or the flow velocity sensor (105), the carbon dioxide sensor (106), the air inlet valve (109) and the gas sampling bag (110) are sequentially connected after the air blowing port, and the exhalation refrigeration module (103) is used to cool and dehumidify the exhalation pipeline, so that the carbon dioxide content in the exhaled air entering the carbon dioxide sensor (106) for detection is more accurate and reliable; In the offline test mode, the gas sampling bag is connected to the end of the exhalation pipeline of the exhalation collection module to collect the exhaled air to be tested; after the collection is completed, the gas sampling bag is disassembled and transported to the testing location, and connected to the front of the test gas pre-treatment filter membrane (202) for testing; The sensor detection module further comprises a detection air filter membrane (401) arranged in front of the air inlet of the detection air temperature, humidity and pressure sensor (402) and an ambient air filter membrane (407) arranged in front of the air inlet of the ambient air temperature, humidity and pressure sensor (408); the detection air filter membrane (401) is connected to the air outlet end of the pre-exhalation treatment unit, and the ambient air filter membrane (407) is connected to the air outlet end of the ambient air pre-treatment module; The sensor detection module also includes a second control valve (405) for switching the outlet of the first control valve (403) to be connected to the outside or to the gas sensor (406); comparing the test results of the exhaled air temperature, humidity and pressure sensor (402) with the ambient air temperature, humidity and pressure sensor (408); and when the exhaled air pre-treatment fails, directly emptying the air through the second control valve (405), stopping the test, and entering the equipment cleaning process.

2. The method for using the breathalyzer according to claim 1, characterized in that: The pre-exhalation processing unit is provided with a visual module (201) for reading relevant information of the gas sampling bag (110).

3. The method for using the breathalyzer according to any one of claims 1 to 2, characterized in that: The breath tester also includes a power supply module for power supply, a microcomputer control interaction module for control, and a display module for output.

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