Lung cancer expiration sampling device and sampling system

Abstract

The invention provides a lung cancer expiration sampling device and system, and relates to the field of expiration sampling, the lung cancer expiration sampling device comprises a device shell, an air pump, a gas washing bottle and a rotor flow meter are arranged in the device shell, an air inlet of the air pump is communicated with an air outlet of the rotor flow meter through a first pipeline, and an air inlet of the rotor flow meter is communicated with the gas washing bottle through a second pipeline; a potassium permanganate solution is contained in the gas washing bottle; the ethanol extraction agent container is communicated with a gas inlet pipe of the gas washing bottle, and a gas outlet of the gas inlet pipe of the ethanol extraction agent container is connected with the suction nozzle. A gas inlet pipe of the gas washing bottle and a gas inlet pipe of the ethanol extraction agent container are respectively provided with a one-way valve. The volume ratio of potassium permanganate to the solvent in the potassium permanganate solution is 1: 2000. The suction nozzle is also communicated with a saliva interception bottle; the suction nozzle is a silica gel suction nozzle. According to the whole process, the expiration sample is specifically treated, a high-quality sample is provided for lung cancer marker detection based on mass spectrum, and early screening and diagnosis of lung cancer are assisted.

Description

Technical Field

[0001] This invention relates to the field of breath sampling, specifically to a breath sampling device and system for lung cancer. Background Technology

[0002] Lung cancer is one of the deadliest malignant tumors worldwide, and early and accurate detection is of great significance for improving patient survival rates. Volatile organic compounds (VOCs) and other lung cancer biomarkers contained in exhaled breath provide important evidence for non-invasive lung cancer detection.

[0003] Existing devices for lung cancer breath sampling (such as CN115005885A, a breath sampling device for lung cancer diagnosis, and CN110179467B, a breath sampling device for lung cancer diagnosis) have limited functions. They can only collect the patient's exhaled gas and cannot extract the target components of the exhaled gas or remove impurities from the exhaled gas. Summary of the Invention This invention provides a lung cancer breath sampling device and sampling system to solve the technical problem mentioned in the background art: existing devices for lung cancer breath sampling (such as CN115005885A a respiratory sampling device for lung cancer diagnosis, CN110179467B a respiratory sampling device for lung cancer diagnosis) have limited functions and can only collect the patient's exhaled gas.

[0004] To address the aforementioned technical problems, this invention discloses a lung cancer breath sampling device, comprising: The device housing contains an air pump, a gas washing bottle, and a rotor flow meter. The air pump inlet and the rotor flow meter outlet are connected by a pipe, and the rotor flow meter inlet and the gas washing bottle are connected by a pipe. The gas washing bottle contains a potassium permanganate solution. An ethanol extractant container is provided, wherein the ethanol extractant container is connected to the inlet pipe of a gas washing bottle, and the outlet of the inlet pipe of the ethanol extractant container is connected to a suction nozzle.

[0005] Preferably, both the gas inlet pipe of the gas washing bottle and the gas inlet pipe of the ethanol extractant container are equipped with one-way valves.

[0006] Preferably, the volume ratio of potassium permanganate to solvent in the potassium permanganate solution is 1:2000.

[0007] Preferably, the suction nozzle is also connected to a saliva retention bottle; the suction nozzle is a silicone suction nozzle.

[0008] This invention discloses a lung cancer breath sampling system, including a lung cancer breath sampling device as described above.

[0009] Preferably, the nozzle is connected to an air intake pipe, and a control valve is provided on the air intake pipe; an exhaust pipe is provided on the air intake pipe at the inlet side of the control valve, and an exhaust valve is provided on the exhaust pipe; after wearing the nozzle (8), the control valve is in the closed state and the exhaust valve is in the open state until the initial preset time is used to close the exhaust valve and open the control valve.

[0010] Preferably, the lung cancer breath sampling system also includes: Expiratory parameter monitoring device: installed on the inlet side of the mouthpiece or inlet tube; the expiratory parameter monitoring device is used to collect the patient's expiratory parameters, including: expiratory flow rate and expiratory temperature; Non-contact solution detection module: used to detect key parameters of the solution in the ethanol extractant container; The intelligent control device is electrically connected to the exhalation parameter monitoring device, the solution non-contact detection module, and the control valve, respectively. The working stages of the air pump are divided into: initial intake stage, basic reaction stage, and deep enrichment stage; each stage has a preset basic stage duration.

[0011] Preferably, the intelligent control device includes: Module 1: Used to determine key expiratory state parameters based on the monitoring results of the expiratory parameter monitoring device within an initial preset time period; key expiratory state parameters include: expiratory absolute temperature gradient and expiratory flow rate fluctuation. Module for building: Used to build a fitting curve of time-expiratory flow rate fluctuation within an initial preset duration; Determine Module 2: Used to determine the fractal value of the expiratory waveform based on the fitted curve; Module 3: Used to determine pathological state values ​​based on key expiratory parameters and fractal values ​​of expiratory waveforms; Module 4: Predicted change parameters for key parameters of ethanol solutions based on pathological state values; Determine Module 5: Determine the duration of the correction phase for each stage of the predicted change parameters based on key parameters of the ethanol solution; Module Six: This module determines the first required flow rate of the ethanol extractant container at each stage based on the pathological state value and the predicted changes in key parameters of the ethanol solution. The control module controls the control valve to open to perform the initial inhalation stage. Module 7: Based on the actual changes in the key parameters of the ethanol solution in the previous stage and the first required flow rate of the ethanol extractant container in the next stage, determine the target required flow rate of the ethanol extractant container in the next stage. Control module: Controls the air pump to perform the corresponding stage of work based on the first or target flow rate of the ethanol extractant container at each stage and the duration of the correction stage.

[0012] Preferred options also include: Density detection module: Located on the air inlet side of the mouthpiece or air inlet tube; used to detect the exhalation density within an initial preset time period; Determine Module 8: Used to determine the basic speed compensation coefficient based on Determine Module 1; The intelligent management module includes: Storage Unit 1: Used to store the air pump's speed-standard flow rate curve; Sampling unit: used to sample the air pump operation data and the air inlet flow rate of the ethanol extractant container according to the time series; Storage unit 2: Used to store the data acquired by the sampling unit; Calibration Unit 1: Used to establish speed compensation coefficient 1 based on data obtained from the sampling unit of the latest predetermined duration 1, and to establish speed compensation coefficient 2 based on data obtained from the sampling unit of the latest predetermined duration 1; Ethanol concentration non-contact detection unit: used to detect the concentration of the solution in the ethanol extractant container; Calibration Unit 2: Used to determine the rotation speed compensation coefficient 3 based on the concentration of the ethanol extractant solution in the container during the previous consecutive target time period 2; Rotation speed determination unit one: used to establish an initial comprehensive rotation speed compensation value based on the basic rotation speed compensation coefficient, rotation speed compensation coefficient one, and rotation speed compensation coefficient two, and to perform initial sampling of the current patient based on the control air pump; Speed ​​determination unit two: used to establish a first comprehensive speed compensation value based on the basic speed compensation coefficient, speed compensation coefficient one, speed compensation coefficient two, and speed compensation coefficient three, and to control the air pump to complete sampling of the current patient based on it.

[0013] The technical solution of the present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0014] Compared with the prior art, the present invention has the following beneficial effects: High sample purity: saliva trapping bottles prevent saliva contamination, potassium permanganate solution can oxidize and remove interfering impurities in the gas, and ethanol extraction helps enrich markers, improving the accuracy of subsequent detection.

[0015] Controllable and stable airflow: The air pump provides power and the rotor flow meter precisely controls the flow, ensuring a stable sampling process and ensuring sample repeatability.

[0016] Good user experience and safety: The silicone nozzle is soft and comfortable, and the one-way valve prevents liquid and gas backflow, avoiding cross-contamination and equipment damage.

[0017] The entire process specifically processes exhaled breath samples, providing high-quality samples for mass spectrometry-based lung cancer biomarker detection, thus aiding in early lung cancer screening and diagnosis. Attached Figure Description

[0018] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used in conjunction with embodiments of the invention to explain the invention and do not constitute a limitation thereof. In the drawings: Figure 1 This is a schematic diagram of the internal structure of the sampling device of the present invention; Figure 2 This is a schematic diagram of the overall sampling device of the present invention. In the diagram: 1. Device casing; 2. Air pump; 3. Gas washing bottle; 4. Rotor flow meter; 5. Pipeline 1; 6. Pipeline 2; 7. Ethanol extractant container; 8. Suction nozzle; 9. One-way valve; 10. Saliva trap; 11. Gas washing bottle inlet pipe; 12. Ethanol extractant container inlet pipe. Detailed Implementation

[0019] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0020] Furthermore, in this invention, the use of terms such as "first" and "second" is for descriptive purposes only and does not specifically refer to any order or sequence, nor is it intended to limit the invention. They are merely used to distinguish components or operations described using the same technical terms and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined with "first" or "second" may explicitly or implicitly include at least one of those features. Additionally, the technical solutions and features of the various embodiments can be combined with each other, but this must be based on the ability of those skilled in the art to implement them. If a combination of technical solutions is contradictory or impossible to implement, it should be considered that such a combination of technical solutions does not exist and is not within the scope of protection claimed by this invention.

[0021] The present invention provides the following embodiments: Example 1: This embodiment of the invention provides a lung cancer breath sampling device, such as... Figures 1-2 As shown, it includes: The device housing 1 contains an air pump 2, a gas washing bottle 3, and a rotor flow meter 4. The air inlet of the air pump 2 and the air outlet of the rotor flow meter 4 are connected by a pipe 5. The air inlet of the rotor flow meter 4 and the gas washing bottle 3 are connected by a pipe 6. The gas washing bottle 3 contains a potassium permanganate solution. An ethanol extractant container 7 (with a volume of 2 ml) is connected to the inlet tube 11 of the gas washing bottle, and the outlet of the inlet tube 12 of the ethanol extractant container is connected to the mouthpiece 8; pure ethanol is used as the extractant in order to collect as many metabolites as possible from the exhaled gas. Preferably, the inlet pipe 11 of the gas washing bottle and the inlet pipe 12 of the ethanol extractant container are both equipped with one-way valves 9.

[0022] Preferably, the volume ratio of potassium permanganate to solvent in the potassium permanganate solution is 1:2000.

[0023] Preferably, the suction nozzle 8 is also connected to the saliva retention bottle 10 (with a volume of 4 ml).

[0024] Preferably, the suction nozzle 8 is a silicone suction nozzle.

[0025] Prepare a potassium permanganate solution (1:2000) and place it in gas washing bottle 3; connect the tubing and take 1 ml of potassium permanganate solution and put it into a 2 ml brown vial; after checking that everything is correct, bite down on the mouthpiece (sampling time 1-8 min) and turn on the power switch to collect exhaled gas.

[0026] The present invention also discloses a lung cancer breath sampling system, including the aforementioned lung cancer breath sampling device.

[0027] The working principle of the above technical solution is as follows: The patient exhales through a silicone nozzle 8. The exhaled air is first filtered through a saliva trap 10 to remove saliva, and then enters an ethanol extractant container 7 for preliminary extraction by contacting ethanol (to extract lung cancer-related volatile organic compounds (VOCs) and other markers from the exhaled air). Subsequently, the air enters a gas washing bottle 3 through inlet tubes (11, 12, with a one-way valve to prevent backflow). The potassium permanganate solution (volume ratio 1:2000) in the gas washing bottle oxidizes and removes interfering impurities from the air. The gas pump 2 provides power, and the rotor flow meter 4 controls the airflow speed, ultimately ensuring that the processed gas is sampled according to the set procedure, providing a clean sample containing lung cancer markers for subsequent mass spectrometry detection.

[0028] The beneficial effects of the above technical solution are as follows: High sample purity: saliva trapping bottles prevent saliva contamination, potassium permanganate solution can oxidize and remove interfering impurities in the gas, and ethanol extraction helps enrich markers, improving the accuracy of subsequent detection.

[0029] Controllable and stable airflow: The air pump provides power and the rotor flow meter precisely controls the flow, ensuring a stable sampling process and ensuring sample repeatability.

[0030] Good user experience and safety: The silicone nozzle is soft and comfortable, and the one-way valve prevents liquid and gas backflow, avoiding cross-contamination and equipment damage.

[0031] The entire process specifically processes exhaled breath samples, providing high-quality samples for mass spectrometry-based lung cancer biomarker detection, thus aiding in early lung cancer screening and diagnosis. In Example 2, based on Example 1, the nozzle 8 is connected to an air intake pipe, and a control valve is installed on the air intake pipe; an exhaust pipe is installed on the air intake pipe at the inlet side of the control valve, and an exhaust valve is installed on the exhaust pipe; after wearing the nozzle 8, the control valve is in the closed state and the exhaust valve is in the open state until the initial preset time is used to close the exhaust valve and open the control valve.

[0032] The beneficial effects of the above technical solution are as follows: The exhalation parameters are monitored based on an initial preset duration, and the relevant parameters of the actual sampling can be adjusted based on the monitoring results.

[0033] Example 3, based on Example 2, further includes: Expiratory parameter monitoring device: installed on the inlet side of the mouthpiece 8 or the inlet tube; the expiratory parameter monitoring device is used to collect the patient's expiratory parameters, including: expiratory flow rate and expiratory temperature; Non-contact solution detection module: used to detect key parameters of the solution in ethanol extractant container 7; The intelligent control device is electrically connected to the exhalation parameter monitoring device, the solution non-contact detection module, and the control valve, respectively. The working stages of the air pump 2 are divided into: initial inhalation stage, basic reaction stage, and deep enrichment stage; each stage has a preset basic stage duration (the above working stages are divided for a single sampling).

[0034] Non-contact solution detection module: used to detect key parameters of the ethanol solution in ethanol extractant container 7; specifically, at least one of the following parameters: - Ethanol solution concentration and pH: Miniature fiber optic probes (transmitter + receiver) are installed opposite each other on both sides of the gas washing bottle, with synchronous output from the transmitter. Dual-wavelength detection light (210nm+290nm), penetrating the bottle wall (glass / plastic) and then being collected by the receiving end; -Concentration detection principle: The absorption intensity of ethanol solution to 210nm light is positively correlated with concentration (following Lambert-Beer law), and the concentration can be directly calculated from the absorbance at 210nm; -pH detection principle: Changes in the pH of the solution alter the hydrogen bonding of ethanol molecules, resulting in a characteristic shift in the absorbance of 290nm light. pH can be inversely determined using the absorbance ratio of 290nm to 210nm. (The relationship between the ratio and pH was calibrated in advance using a standard solution); Solution temperature: Temperature field measured on the wall of the ethanol extractant container 7 using a fiber optic grating; In lung cancer exhalation, the concentration and form of biomarkers change with each stage of exhalation (e.g., the initial exhalation contains high concentrations of volatile substances, while the later exhalation contains poorly reacting protein fragments). Staged control by the air pump can: - Initial inhalation phase: Rapidly captures "high-concentration peak airflow"; -Basic reaction stage: Use a stable low flow rate (e.g., 0.8-1.2 L / min) to allow readily reactive markers (e.g., VOCs with an affinity for ethanol) to react rapidly with ethanol. Utilizing the polar solubility properties of ethanol to "enrich polar markers" ; -Deep enrichment stage: Further reduce the flow rate and extend the time (e.g., flow rate 0.5-0.8 L / min, duration 3-5 seconds) to allow difficult-to-react markers (such as non-polar long-chain organic compounds and protein complexes) to fully diffuse and contact in the ethanol solution. The beneficial effects of the above technical solution are as follows: Staged airflow adaptation: Initial inhalation phase: High flow rate rapidly captures "high concentration peak airflow" and utilizes the high volatility of ethanol to simultaneously lock volatile biomarkers (such as VOCs) in exhalation, avoiding biomarker loss due to ethanol evaporation, and increasing the volatile biomarker capture rate by 25%.

[0035] Basic reaction stage: A stable low flow rate allows ethanol to act as a polar solvent, rapidly dissolving and reacting polar markers such as VOCs, "clearing" the reaction sites in the solution, and preparing for deep enrichment.

[0036] Deep enrichment stage: Further reduce the flow rate and extend the duration (e.g., 5 seconds) to utilize the dissolution and diffusion properties of ethanol, allowing difficult-to-react biomarkers (such as non-polar long-chain organic compounds and protein complexes) to fully diffuse and contact in the ethanol solution, thereby improving the detection rate of difficult-to-react biomarkers.

[0037] Ethanol concentration and pH monitoring: The fiber optic probe non-invasively detects the concentration and pH of the ethanol solution (avoiding contact with contaminated ethanol), and provides real-time feedback on the state changes of ethanol due to volatilization and reaction; the parameters for the next stage are adjusted based on the state changes.

[0038] Multi-parameter linkage control: Expiratory parameters (flow rate, temperature) and ethanol solution parameters (concentration, pH) are linked in real time to automatically adapt to different patients (e.g., for patients with fever, the expiratory temperature is high, so the initial inhalation phase is shortened to inhibit ethanol evaporation), achieving "precise sampling driven by ethanol characteristics".

[0039] Example 4, based on Example 3, the intelligent control device includes: Module 1: Used to determine key expiratory state parameters based on the monitoring results of the expiratory parameter monitoring device within an initial preset time period; key expiratory state parameters include: expiratory absolute temperature gradient and expiratory flow rate fluctuation. Module for building: Used to build a fitting curve of time-expiratory flow rate fluctuation within an initial preset duration; Determine Module 2: Used to determine the fractal value of the expiratory waveform based on the fitted curve; Module 3: Used to determine pathological state values ​​based on key expiratory parameters and fractal values ​​of expiratory waveforms; Module 4: Predicted change parameters for key parameters of ethanol solutions based on pathological state values; Determine Module 5: Determine the duration of the correction phase for each stage of the predicted change parameters based on key parameters of the ethanol solution; Module Six: This module determines the first required flow rate of the ethanol extractant container 7 at each stage based on the pathological state value and the predicted change parameters of key parameters of the ethanol solution. The control module controls the control valve to open to perform the initial inhalation stage. Module 7: Based on the actual changes in the key parameters of the ethanol solution in the previous stage and the first required flow rate of the ethanol extractant container 7 in the next stage, determine the target required flow rate of the ethanol extractant container 7 in the next stage. Control module: Based on the first required flow rate (specifically the air inlet flow rate of the ethanol extractant container 7) or the target required flow rate (specifically the air inlet flow rate of the ethanol extractant container 7) of each stage and the duration of the correction stage, control the air pump 2 to perform the corresponding stage's work.

[0040] The present invention may also consist of only determining modules one through five.

[0041] The initial stage control module selects the first required flow rate of the ethanol extractant container 7. The target flow rate of the ethanol extractant container 7 in other stage control modules. The following methods can be used: fix the control parameters of the air pump 2 and adjust the opening of the control valve; or fix the opening of the control valve and adjust the control parameters of the air pump to ensure the required flow rate. Expiratory temperature gradient (unit: ℃ / s, rate of change of temperature over time); expiratory absolute temperature gradient is the absolute value of the expiratory temperature gradient. Expiratory flow rate fluctuation (standard deviation / mean of flow rate over a certain period of time); Determining Module Two: Used to determine the fractal value of the expiratory waveform based on the fitted curve; specifically: Fractal value F of the expiratory waveform: ; The maximum value of the expiratory flow rate fluctuation of the fitted curve; This is the minimum expiratory flow rate fluctuation of the fitted curve; This represents the average expiratory flow rate fluctuation of the fitted curve; The fractal evaluation coefficient (values ​​are greater than 0 and less than 1, and can be greater than or equal to 0.3 and less than or equal to 0.8). The specific calculations for Module 3 are as follows: ; Where P is the pathological state value; The maximum absolute temperature gradient of exhalation in a healthy person; The maximum absolute temperature gradient of exhalation within the initial preset duration; The fractal value of the exhalation waveform of a healthy person; , The weights are the fractal shape of the expiratory waveform and the absolute temperature gradient of the expiratory flow, respectively (both values ​​are greater than 0 and less than 1, and their sum is 1; they can be 0.4 and 0.6 respectively; they can be obtained through any one of the following methods: logistic regression training, clinical experience method, orthogonal experimental method, or expert consensus method (industry standard setting). When P > 1.2, it is judged as a "high-risk pathological state for lung cancer"; When P < 0.8, it is judged as "respiratory depression / healthy state"; The value is limited to 0.8-1.2; The specific calculations for Module 4 are as follows: ; The predicted change parameter (rate of change; such as the rate of change of ethanol temperature and the rate of change of ethanol concentration, etc.) for the j-th key parameter of the ethanol solution. This is the fundamental variation parameter of the j-th key parameter of the ethanol solution; The compensation coefficient for the j-th key parameter of the ethanol solution (obtained through any one of logistic regression training, clinical experience method, orthogonal experimental method, or expert consensus method (industry standard setting); the value is greater than 0 and less than 1). These are reference values ​​for pathological states in healthy individuals.

[0042] The calculation for Module 5 is determined as follows: ; in, The duration of the correction phase in the k-th phase; Y represents the base duration of the k-th stage (the theoretical duration of the k-th stage in a healthy person under normal conditions); Y represents the total number of key parameters for the ethanol solution. The duration compensation weight for the j-th key parameter of the ethanol solution (with a value greater than -1 and less than 1; it can be obtained through any one of logistic regression training, clinical experience method, orthogonal experimental method, or expert consensus method (industry standard setting); different weights can also be used for different scenarios). The value ranges from -0.5 to 0.5; The calculation for Module Six is ​​determined as follows: ; This represents the first demand flow in the k-th stage; This represents the baseline flow rate for the k-th stage (the theoretical flow rate for the k-th stage in a healthy person under normal conditions). The flow compensation coefficient for pathological conditions (values ​​are greater than 0 and less than 0.3; it can be obtained through any one of the following methods: logistic regression training, clinical experience method, orthogonal experiment method, or expert consensus method (industry standard setting)). The flow compensation weight for the j-th key parameter of the ethanol solution (values ​​are greater than -1 and less than 1; it can be obtained through any one of logistic regression training, clinical experience method, orthogonal test method, or expert consensus method (industry standard setting); different weights can also be used according to different scenarios). The calculation for Module 7 is determined as follows: ; in, The target demand flow for the k-th stage; The actual change parameter of the j-th key parameter of the ethanol solution in the (k-1)-th stage; The beneficial effects of the above technical solution are as follows: By integrating the expiratory absolute temperature gradient (reflecting abnormal respiratory heat exchange) and expiratory flow rate fluctuation (reflecting respiratory pattern disorder), the complexity of the respiratory waveform is quantified by the fractal value F, and then combined with the pathological state value P to achieve a precise mapping from "physiological abnormality to pathological state".

[0043] The pathological state value P breaks through the "health / disease" meta-determination. Through a continuous value range of 0.8-1.2, it dynamically reflects the state gradient of respiratory depression (P<0.8), healthy transition (0.8≤P≤1.2), and high risk of lung cancer (P>1.2), providing a continuous quantitative indicator for early disease screening and disease progression monitoring, and assisting doctors to more accurately assess the respiratory pathological risk of patients.

[0044] Based on the pathological state P and key ethanol parameters (concentration, temperature change rate), ethanol parameters are dynamically corrected. When the concentration of biomarkers in the exhaled breath of high-risk lung cancer patients is high, the ethanol concentration change rate is automatically compensated and enhanced, making the dissolution and extraction of ethanol and exhaled biomarkers more suitable for pathological characteristics. The extraction efficiency of lung cancer biomarkers (such as volatile organic compounds) is improved, which helps to improve the accuracy of subsequent detection.

[0045] The phase duration and flow rate are coordinated to control and correct the phase duration, which is correlated with changes in ethanol parameters to ensure that the contact time between ethanol and exhalation is reasonable under different pathological conditions (e.g., prolonged contact time for high-risk lung cancer to ensure sufficient extraction). The first required flow rate and the target required flow rate are combined with pathological compensation and changes in ethanol parameters to dynamically adjust the ethanol flow rate, avoiding insufficient extraction or waste caused by a fixed flow rate, and improving the utilization rate of ethanol reagent.

[0046] Example 5, based on Example 2, further includes: Density detection module: installed on the air inlet side of the mouthpiece or air inlet tube; used to detect expiratory density within an initial preset time (10-30 seconds); Determine Module 8: Used to determine the basic speed compensation coefficient based on Determine Module 1; The intelligent management module includes: Storage Unit 1: Used to store the speed-standard flow rate curve of air pump 2; Sampling unit: used to sample the operating data of air pump 2 (such as actual speed and flow rate) and the inlet flow rate of ethanol extractant container 7 according to the time series; Storage unit 2: Used to store the data acquired by the sampling unit; Calibration Unit 1: Used to establish speed compensation coefficient 1 based on data obtained from the sampling unit of the latest predetermined duration 1, and to establish speed compensation coefficient 2 based on data obtained from the sampling unit of the latest predetermined duration 1; Ethanol concentration non-contact detection unit: used to detect the concentration of the solution in ethanol extractant container 7; Calibration Unit 2: Used to determine the rotation speed compensation coefficient 3 based on the solution concentration in the ethanol extractant container 7 of the previous continuous target time period 2; Rotation speed determination unit 1: used to establish an initial comprehensive rotation speed compensation value based on the basic rotation speed compensation coefficient, rotation speed compensation coefficient 1, and rotation speed compensation coefficient 2, and to perform initial sampling of the current patient based on the control air pump 2; Speed ​​determination unit 2: used to establish the first comprehensive speed compensation value based on the basic speed compensation coefficient, speed compensation coefficient 1, speed compensation coefficient 2, and speed compensation coefficient 3, and to control the air pump 2 to complete sampling of the current patient based on it.

[0047] The speed-standard flow rate curve is a benchmark of the "input-output" characteristics obtained through calibration experiments. It primarily records the theoretical output flow rate of the air pump at different speeds, reflecting the equipment's operating performance under ideal conditions. In the calibration experiments, the gas can be clean air; the ethanol extractant container 7 contains the standard ethanol concentration and volume (the theoretical setting value of the exhalation sampling device); the gas washing bottle 3 contains the standard potassium permanganate solution concentration and volume (the theoretical setting value of the exhalation sampling device). Basic speed compensation coefficient The calculation is as follows: ; The expiratory density detected by the density detection module; To obtain the rotational speed-standard flow rate curve, the gas density in the experiment was determined. Calibration Unit 1: Used to establish the speed compensation coefficient 1 based on data acquired by the sampling unit of Storage Unit 1 and the latest predetermined duration 1. And establish the speed compensation coefficient two using data obtained from the sampling unit based on the latest predetermined duration one. Specifically: ; M is the rotation speed compensation coefficient (with a value greater than or equal to 0.8 and less than 1); M is the total number of consecutive target time periods (the required flow rates of the air pump / ethanol extractant container 7 are the same for consecutive target time periods) obtained within the latest predetermined duration (which can be 10-30 minutes; it is the historical sampling process of the sampling device); The actual flow rate of the ethanol extractant container 7 during the i-th consecutive target time period obtained within the latest scheduled duration; The required flow rate of ethanol extractant container 7 for the i-th consecutive target time period within the latest scheduled duration; ; The actual flow rate of air pump 3 during the i-th consecutive target time period obtained within the latest scheduled duration; Calibration Unit Two: Used to determine the rotation speed compensation coefficient three based on the solution concentration in the ethanol extractant container 7 during the previous continuous target time period two (meaning similar to continuous target time period one, but shorter in duration; values ​​can be 10-30 seconds, representing the current patient's sampling process). Specifically: ;in, The value detected by the non-contact ethanol concentration detection unit; The standard ethanol concentration; Initial comprehensive speed compensation value = ; First comprehensive speed compensation value = ; For current demand traffic The speed corresponding to the speed-standard flow curve of air pump 2.

[0048] The beneficial effects of the above technical solution are as follows: Multi-dimensional compensation to adapt to the expiratory heterogeneity of lung cancer: Through four levels of compensation—basal motor speed compensation coefficient (expiratory density), motor speed compensation coefficient one (ethanol flow deviation), motor speed compensation coefficient two (pump flow deviation), and motor speed compensation coefficient three (ethanol concentration decay)—the core interferences in lung cancer exhalation are covered. Standardized procedures reduce the false negative rate in clinical settings. The calibration experiment uses clean air and standard reagents to ensure the air pump's speed-flow rate curve aligns with the clinical sampling process, resulting in a multi-center data deviation of less than 5%, thus avoiding false negative results due to equipment differences. Furthermore, adaptive corrections are made based on the different speeds required for different flow rates. Self-calibration capability ensures long-term stable calibration. Unit 1 / 2 automatically corrects the compensation coefficient through "storage unit + sampling data" without manual intervention, ensuring reliable control.

[0049] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A lung cancer breath sampling device, characterized in that: include: The device housing (1) is equipped with an air pump (2), a gas washing bottle (3), and a rotor flow meter (4). The air inlet of the air pump (2) is connected to the air outlet of the rotor flow meter (4) through a pipe (5). The air inlet of the rotor flow meter (4) is connected to the gas washing bottle (3) through a pipe (6). The gas washing bottle (3) contains potassium permanganate solution. An ethanol extractant container (7) is connected to the inlet pipe (11) of a gas washing bottle, and the outlet of the inlet pipe (12) of the ethanol extractant container is connected to a suction nozzle (8).

2. The lung cancer breath sampling device according to claim 1, characterized in that: The inlet pipe (11) of the gas washing bottle and the inlet pipe (12) of the ethanol extractant container are both equipped with one-way valves (9).

3. The lung cancer breath sampling device according to claim 1, characterized in that: The volume ratio of potassium permanganate to solvent in the potassium permanganate solution is 1:2000.

4. The lung cancer breath sampling device according to claim 1, characterized in that: The suction nozzle (8) is also connected to the saliva retention bottle (10); the suction nozzle (8) is a silicone suction nozzle.

5. A lung cancer breath sampling system, characterized in that: Includes a lung cancer breath sampling device as described in any one of claims 1-4.

6. A lung cancer breath sampling system according to claim 5, characterized in that: The nozzle (8) is connected to an air intake pipe, and a control valve is installed on the air intake pipe; an exhaust pipe is installed on the air intake pipe at the inlet side of the control valve, and an exhaust valve is installed on the exhaust pipe; after wearing the nozzle (8), the control valve is in the closed state and the exhaust valve is in the open state until the initial preset time is used to close the exhaust valve and open the control valve.

7. A lung cancer breath sampling system according to claim 6, characterized in that: The lung cancer breath sampling system also includes: Expiratory parameter monitoring device: installed on the inlet side of the mouthpiece (8) or the inlet pipe; the expiratory parameter monitoring device is used to collect the patient's expiratory parameters, which include: expiratory flow rate and expiratory temperature; Solution non-contact detection module: used to detect key parameters of the solution in the ethanol extractant container (7); The intelligent control device is electrically connected to the exhalation parameter monitoring device, the solution non-contact detection module, and the control valve, respectively. The working stages of the air pump (2) are divided into: initial air intake stage, basic reaction stage, and deep enrichment stage; each stage has a preset basic stage duration.

8. A lung cancer breath sampling system according to claim 7, characterized in that: The intelligent control device includes: Module 1: Used to determine key expiratory state parameters based on the monitoring results of the expiratory parameter monitoring device within an initial preset time period; key expiratory state parameters include: expiratory absolute temperature gradient and expiratory flow rate fluctuation. Module for building: Used to build a fitting curve of time-expiratory flow rate fluctuation within an initial preset duration; Determine Module 2: Used to determine the fractal value of the expiratory waveform based on the fitted curve; Module 3: Used to determine pathological state values ​​based on key expiratory parameters and fractal values ​​of expiratory waveforms; Module 4: Predicted change parameters for key parameters of ethanol solutions based on pathological state values; Determine Module 5: Determine the duration of the correction phase for each stage of the predicted change parameters based on key parameters of the ethanol solution; Module 6: Used to determine the first required flow rate of the ethanol extractant container (7) at each stage based on the pathological state value and the predicted change parameters of the key parameters of the ethanol solution. The control module controls the control valve to open to carry out the work of the initial inhalation stage. Determine Module 7: Based on the actual changes in the key parameters of the ethanol solution in the previous stage and the first demand flow rate of the ethanol extractant container (7) in the next stage, determine the target demand flow rate of the ethanol extractant container (7) in the next stage. Control module: Controls the gas pump (2) to perform the corresponding stage operation based on the first or target demand flow rate of the ethanol extractant container (7) and the duration of the correction stage.

9. A lung cancer breath sampling system according to claim 6, characterized in that: Also includes: Density detection module: installed on the inlet side of the nozzle (8) or the air inlet pipe; Used to detect expiratory density within an initial preset duration; Determine Module 8: Used to determine the basic speed compensation coefficient based on Determine Module 1; The intelligent management module includes: Storage Unit 1: Used to store the speed-standard flow rate curve of the air pump (2); Sampling unit: used to sample the operating data of the air pump (2) and the air flow rate of the ethanol extractant container (7) according to the time series; Storage unit 2: Used to store the data acquired by the sampling unit; Calibration Unit 1: Used to establish speed compensation coefficient 1 based on data obtained from the sampling unit of the latest predetermined duration 1, and to establish speed compensation coefficient 2 based on data obtained from the sampling unit of the latest predetermined duration 1; Ethanol concentration non-contact detection unit: used to detect the concentration of the solution in the ethanol extractant container (7); Calibration Unit 2: Used to determine the rotation speed compensation coefficient 3 based on the solution concentration in the ethanol extractant container (7) of the previous continuous target time period 2; Speed ​​determination unit 1: used to establish an initial comprehensive speed compensation value based on the basic speed compensation coefficient, speed compensation coefficient 1, and speed compensation coefficient 2, and to perform initial sampling of the current patient based on the control air pump (2); Speed ​​determination unit two: used to establish the first comprehensive speed compensation value based on the basic speed compensation coefficient, speed compensation coefficient one, speed compensation coefficient two, and speed compensation coefficient three, and to control the air pump (2) to complete sampling of the current patient based on it.

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