Household portable expired gas nitric oxide analysis device

Abstract

The invention discloses a household portable exhaled gas nitric oxide analysis device, and relates to the technical field of exhaled gas detection, and the household portable exhaled gas nitric oxide analysis device comprises an intelligent interaction module which is wirelessly connected with a terminal in a wireless mode; the expiration sampling module adopts a T-shaped air passing pipeline, one end of the expiration sampling module is used for feeding expiration of a patient, the other end of the expiration sampling module is used for discharging expiration, and the third end of the expiration sampling module is connected with the expiration analysis module by connecting an analysis sucking pump; the expiration analysis module is used for analyzing and calculating the sampled gas through an intelligent expiration algorithm; and the wireless transmission module is used for uploading an analysis result to a terminal. According to the invention, through accurate calculation and reasonable matching of pipe diameters and lengths of all sections of pipelines at the end A and the end B of the T-shaped gas circuit and design of parameters of all sections of the gas circuit, the volume of the gas chamber is obviously reduced on the premise of not changing the overall detection performance; the flow and distribution of the gas in the pipeline are controlled by using the T-shaped gas path structure, so that the requirement of the sensor on the analysis gas quantity is met under the condition of smaller gas chamber volume, and the miniaturization of the device is realized.

Description

Technical Field

[0001] This invention relates to the field of exhaled breath testing technology, and more specifically to a home-use portable exhaled nitric oxide analyzer. Background Technology

[0002] Exhaled nitric oxide analyzers for respiratory diseases (hereinafter referred to as gas analyzers) are widely used in routine diagnostic tests in hospitals of all levels both domestically and internationally. The market and value of respiratory gas analyzers are similar to those of diabetes blood glucose meters. Both diseases have comparable morbidity, mortality, and socioeconomic burden, ranking third and fourth respectively among the major diseases requiring key prevention and control as published by the World Health Organization and relevant Chinese departments. Both instruments are primarily based on electrochemical sensor technology and are used for the diagnosis and treatment monitoring of the two types of diseases, respectively. Diabetes blood glucose meters have undergone more than 60 years of development, gradually expanding from hospital-specific diagnostic tools to the home market for patients to monitor their own treatment efficacy. Today, the home market accounts for at least 80% of the entire blood glucose testing market. However, the development of electrochemical sensor gas analyzers for respiratory diseases is less than 20 years old and has not yet entered the home market. Patients and doctors with respiratory diseases urgently hope to have a gas analyzer that is as economical, reliable, compact, and portable as a diabetes blood glucose meter.

[0003] Compared to blood glucose electrochemical sensors, breath electrochemical sensors are several times larger and have a much longer response time, thus requiring a larger sample storage space or sample chamber. Furthermore, unlike blood glucose or other breath or gas detection methods, respiratory gas testing also requires sensing and braking devices to monitor expiratory pressure, flow rate, emptying, and analytical sampling to ensure the reliability of clinical test results, further increasing the instrument's size and cost.

[0004] By developing smaller, shorter-response-time planar semiconductor and electrochemical sensors, Bosch in Germany and Sunwo in China have successively launched small-sized, low-cost home-use respiratory air quality detectors, namely the Bosch Vivatmopro and the Sunwo HA1101. The HA1101 is about the same size as the Omron HEM-7132 blood pressure monitor. Its detection limit, accuracy, repeatability, and interference resistance all meet domestic and international standards. It has been clinically certified to be completely equivalent to the earliest commercially available and widely used SUNVOU CA2122 and MINO VERO devices in hospitals both domestically and internationally. Bosch's instrument is about the size of a laptop, plus a razor-sized handheld filter, used to convert NO to NO2 for detection. Its performance is lower than the HA1101 (detection limit and accuracy HA 3pbb, better than Bosch's 10ppb). The size, cost, and price of these two instruments are still far higher than home blood glucose meters, and they can only be considered desktop home air quality detectors, not portable devices like blood glucose meters.

[0005] Meanwhile, existing standards for breath sampling do not adequately consider the actual circumstances of different populations. For example, the "ATS / ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005" standard specifies 6 seconds for children and 10 seconds for adults, but this is difficult to complete in a single breath for children under 8 years old or individuals with breathing difficulties. Furthermore, the anatomical dead space volume varies across different age groups, and traditional fixed-time breath sampling methods cannot accurately meet the needs of different individuals.

[0006] Therefore, how to propose a home-use portable exhaled nitric oxide analyzer that is portable, easy to operate, accurate in sampling, and low in cost; reduces the use of solenoid valves and lowers the power consumption of the instrument; and adapts to different populations by optimizing the gas path and pump valve coordination and intelligent exhalation algorithms are problems that urgently need to be solved by those skilled in the art. Summary of the Invention

[0007] In view of this, the present invention provides a home-use portable exhaled nitric oxide analyzer. Through a comprehensive integrated design encompassing an intelligent interaction module, a wireless transmission module, an exhaled breath sampling module, and a gas analysis module, it achieves analytical and detection performance equivalent to current hospital equipment, but with a significantly reduced instrument size and operating costs reduced by more than tenfold. Furthermore, it achieves portability, ease of operation, accurate sampling, and low operating costs; reduces the use of solenoid valves, lowering instrument power consumption; optimizes the gas path and pump valve coordination; and utilizes an intelligent exhaled breath algorithm to adapt to different user groups. To achieve the above objectives, the present invention adopts the following technical solution:

[0008] A portable home-use exhaled nitric oxide analyzer includes: an intelligent interaction module, an exhaled breath sampling module, an exhaled breath analysis module, and a wireless transmission module;

[0009] The intelligent interaction module is used to wirelessly connect to the terminal.

[0010] The exhalation sampling module uses a T-shaped air passage, with one end for the patient to exhale and inhale, the other end for the patient to exhale and expel air, and the third end connected to the exhalation analysis module via an analysis pump.

[0011] The exhalation analysis module is used to analyze and calculate the sampled gas using an intelligent exhalation algorithm;

[0012] The wireless transmission module is used to upload the analysis results to the terminal.

[0013] Optionally, the intelligent interaction module includes: a diaphragm sensor, an NFC module, a Bluetooth module, and a voice module. The NFC module and the Bluetooth module are both connected to the terminal signal. The terminal is placed on the diaphragm sensor, which is used to sense pressure changes caused by the placement of the terminal. The voice module is used to provide voice operation prompts.

[0014] Optionally, the intelligent exhalation algorithm includes:

[0015] Dead space maximum = weight * V + K * age;

[0016] Where V is the anatomical dead space volume per kilogram of body weight, and K is the correction factor.

[0017] Optionally, the T-shaped gas flow channel includes: an A-end structure, a B-end structure, a C-end structure, and a T-shaped connector. The A-end structure, B-end structure, and C-end structure are connected through the T-shaped connector. The C-end structure includes a gas analysis channel, a suction pump, and an exhalation analysis module connected in sequence. The A-end structure includes a handle portion A1 and a tubing portion A2 connected in sequence. The B-end structure includes a first section of tubing B1 and a second section of tubing B2 connected in sequence. The gas flow rate through the B-end structure is adjusted by adjusting the diameter of the A-end structure and the B-end structure, thereby distributing the flow rate of the T-shaped gas flow channel.

[0018] Optionally, the diameter of the first section of pipe B1 is matched with that of the tracheal section A2.

[0019] Optionally, it also includes a pressure sensor, which is installed on the inner wall of the T-connector to detect the pressure of exhaled gas as it enters the T-connector through the A-end structure.

[0020] Optionally, the method of adjusting the gas flow rate through the B-end structure by adjusting the pipe diameters of the A-end and B-end structures, thereby distributing the flow rate of the T-shaped gas pipeline, includes:

[0021] The diameter of the second section of pipe, B2, is d. B2 The length is L B2 The length of segment A2 of the trachea is L. A2 The length of the first pipe section B1 is L. B1 ;

[0022] When the total pumping speed of the pump is Q, the velocity ratio R at both ends of structures A and B is expressed as:

[0023]

[0024] Among them, Q A and Q BThe flow rates of the A-end structure and the B-end structure are respectively, r A2 r B1 r B2 The radii are the pipe radii of section A2 of the trachea, section B1 of the first pipe, and section B2 of the second pipe, respectively. ΔP is the pressure difference between the two ends of the gas path, and μ is the dynamic viscosity of the gas.

[0025] Optionally, the breath sampling module further includes a nitric oxide sensor, which is signal-connected to the breath analysis module.

[0026] Optionally, the exhalation analysis module includes a microprocessor and a storage unit. The microprocessor is connected to the nitric oxide sensor signal. The microprocessor is used to amplify, filter, and perform analog-to-digital conversion on the received signal, and to calculate the concentration of nitric oxide in the exhaled breath according to a preset algorithm. The storage unit is used to store detection data and calibration parameters for data storage and rapid retrieval.

[0027] As can be seen from the above technical solution, compared with the prior art, the present invention discloses a household portable exhaled nitric oxide analyzer, which has the following beneficial effects:

[0028] A portable home-use exhaled nitric oxide analyzer includes: an intelligent interaction module, an exhaled breath sampling module, an exhaled breath analysis module, and a wireless transmission module. The intelligent interaction module wirelessly connects to a terminal. The exhaled breath sampling module uses a T-shaped airflow pipe, with one end for patient exhalation intake, the other end for exhalation exhaust, and the third end connected to the exhaled breath analysis module via an analytical pump. The exhaled breath analysis module analyzes and calculates the sampled gas using an intelligent exhaled breath algorithm. The wireless transmission module uploads the analysis results to the terminal. This invention's exhaled breath analysis module significantly reduces the air chamber volume without altering overall detection performance through precise calculation and reasonable matching of the pipe diameter and length at ends A and B of the T-shaped airflow pipe, as well as careful design of the parameters for each section of the airflow pipe. Utilizing the unique T-shaped airflow structure, the flow and distribution of gas within the pipe can be precisely controlled, ensuring that the sensor's analytical gas volume requirements are met even with a smaller air chamber volume, thus achieving a miniaturized design. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the provided drawings without creative effort.

[0030] Figure 1This is a schematic diagram of the module composition of a household portable exhaled nitric oxide analyzer provided by the present invention.

[0031] Figure 2 This is a schematic diagram of the module function of a household portable exhaled nitric oxide analyzer provided by the present invention.

[0032] Figure 3 This is a schematic diagram of the gas flow velocity simulation analysis provided by the present invention.

[0033] Figure 4 This is a schematic diagram of the simulation analysis of gas path pressure changes provided by the present invention.

[0034] Figure 5 This is a schematic diagram of the T-shaped gas path design provided by the present invention.

[0035] Figure 6 This is a schematic diagram of the exhalation flow monitoring valve device provided by the present invention.

[0036] Among them, 01-thin-walled metal pipe, 02-strain gauge sensor array, 03-needle valve assembly, 04-spring, 05-electromagnetic coil, 06-control module. Detailed Implementation

[0037] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0038] This invention discloses a home-use portable exhaled nitric oxide analyzer, such as... Figure 1 As shown, it includes: an intelligent interaction module, an exhalation sampling module, an exhalation analysis module, and a wireless transmission module;

[0039] The intelligent interaction module is used to wirelessly connect to the terminal.

[0040] The exhalation sampling module uses a T-shaped air passage, with one end for the patient to exhale and inhale, the other end for the patient to exhale and expel air, and the third end connected to the exhalation analysis module via an analysis pump.

[0041] The exhalation analysis module is used to analyze and calculate the sampled gas using an intelligent exhalation algorithm;

[0042] The wireless transmission module is used to upload the analysis results to the terminal.

[0043] In specific implementations, such as Figure 2As shown, a home-use portable exhaled nitric oxide analyzer is suitable for asthma patients. Its functions are implemented through a three-way intelligent interaction module between the user, the instrument, and the mobile phone; an economical exhaled breath sampling module (6x4x2cm); a miniaturized exhaled breath analysis module (6x4x2cm); and a highly efficient and stable wireless transmission module. During use, the patient first performs an exhaled breath sample. Following gas analysis, intelligent algorithm processing, and data transmission, the patient can view the exhaled breath test results in real time on their mobile phone. Based on the test values, the patient can promptly assess the treatment effect and cooperate with remote diagnosis and treatment guidance. Based on this device, diverse user needs can be met according to different usage scenarios.

[0044] In a specific implementation, the intelligent interaction module mainly consists of a diaphragm sensor, an NFC module, a Bluetooth module, and a voice module, enabling intelligent connection with mobile phones or tablets. It features a buttonless power switch; users simply place their phone in the designated area of ​​the instrument, and it automatically powers on. This design effectively solves the problem of cumbersome operation of previous devices, eliminating extra steps for users when turning on the device and significantly improving ease of use.

[0045] After automatic power-on, the phone screen will automatically redirect to the "Yan Guanjia" APP's test interface, providing voice prompts. This seamless and rapid three-way interaction optimizes the user experience, resolving previous delays and inconveniences encountered by users, and ensuring the real-time nature and smoothness of the testing process. Through the above design, this invention significantly improves the usability of the intelligent interaction module, meeting modern users' needs for convenience and efficiency.

[0046] In a specific implementation, the exhalation sampling module adopts a T-shaped air passage design, with one end for the patient's exhalation intake, the other end for the exhalation exhaust, and the third end connected to the analysis pump to achieve connection with the analysis module.

[0047] In traditional designs, pressure and flow sensors are installed at the inlet, while an electromagnetic shut-off valve is fitted at the outlet. The innovation of this invention lies in retaining the pressure and flow sensors while achieving a more balanced distribution of flow and pressure through a rational design of the inlet and outlet pipes, thus eliminating the need for the electromagnetic shut-off valve. This design not only reduces costs but also decreases system size and power consumption.

[0048] Specifically, the flow and pressure distribution in the T-type air circuit is achieved through precise matching of pipe diameter and length. By optimizing the pipe diameter and length, a balance in airflow is ensured during intake and exhaust, resulting in smooth gas flow and avoiding the flow obstruction caused by traditional solenoid valves. At the same time, this design simplifies the structure, reduces potential failure points, and improves system reliability.

[0049] In specific implementations, such as Figure 6 As shown, it also includes an exhalation flow monitoring valve device based on strain gauge sensing and electromagnetic control, comprising a main structure, a detection unit, and a control unit.

[0050] The main structure includes a thin-walled metal pipe 01, with a parabolic diffuser section at the outlet end of the thin-walled metal pipe 01. The detection unit includes a strain gauge sensor array 02 disposed on the outer surface of the thin-walled metal pipe 01. The control unit includes an electromagnetic coil 05, a needle valve assembly 03, and a control module 06. The electromagnetic coil 05 is disposed downstream of the strain gauge sensor array 02, the needle valve assembly 03 is coaxially disposed within the cavity of the electromagnetic coil 05, and the control module 06 is integrated into the outer wall of the thin-walled metal pipe 01 and close to the electromagnetic coil 05.

[0051] The working process of this invention is as follows: When exhaled air flows through the thin-walled metal pipe 01, it generates a small deformation. The strain gauge sensor array 02 detects the small deformation and converts it into an electrical signal. The control module 06 calculates the flow rate and pressure parameters through a preset mathematical model, and controls the position of the needle valve assembly 03 and the state of the spring 04 by adjusting the current of the electromagnetic coil 05, thereby achieving precise flow rate regulation.

[0052] Compared with the prior art, the present invention has the following advantages:

[0053] By integrating the strain gauge sensor array 02 with the electromagnetic control components, separate pressure and flow sensors are eliminated, reducing the complexity of the system.

[0054] The electromagnetic coil 05 and needle valve assembly 03 are used for flow regulation rather than airflow switch, which avoids the use of traditional electromagnetic shut-off valve and simplifies the system structure.

[0055] Through the above technical solutions, the present invention further achieves the effects of miniaturization of system size, reduction of cost and reduction of power consumption.

[0056] In summary, omitting the solenoid valve allows for a larger overall space, lower power consumption, and reduced overall cost, demonstrating the significant advantages of this invention in terms of structural optimization and cost control.

[0057] In specific implementations, traditional breathalyzer devices typically require a large air chamber to accommodate the volume of air the sensor needs to analyze. This not only results in a bulky device that is inconvenient to carry and operate, but also increases manufacturing and operating costs. Furthermore, commercially available air pumps often have high flow rates, exceeding the ideal flow rate range required for detection. To achieve a suitable flow rate of 1-3 mL / s, an additional load is usually needed for adjustment. This not only increases the system's complexity and cost but may also introduce new points of failure, affecting the stability and reliability of the entire detection system.

[0058] The exhalation analysis module of this invention cleverly solves the above-mentioned problems by accurately calculating and rationally matching the diameter and length of each section of the pipe at ends A and B of the T-shaped airway. Figure 5 As shown, through careful design of the parameters of each section of the gas path, the volume of the gas chamber is significantly reduced without changing the overall detection performance. Utilizing a unique T-shaped gas path structure, the flow and distribution of gas within the pipeline can be precisely controlled, ensuring that the sensor's analytical gas volume requirements are met even with a smaller gas chamber volume, thus achieving a miniaturized design of the device.

[0059] A-end structure:

[0060] Handle section A1: This handle section is ergonomically designed for easy gripping by the patient, providing stable support during exhalation. Its reasonable size helps the patient perform exhalation comfortably, ensuring relatively stable expiratory force and flow.

[0061] Tracheal Section A2: The tracheal section is made of medical-grade plastic with a smooth inner wall, effectively reducing gas adsorption and residue within the tube and ensuring the purity of the collected exhaled breath sample. The inner diameter and length parameters of the tube are designed based on fluid dynamics characteristics. The selection of the inner diameter must meet the conditions for laminar gas transport, while the setting of the tube length must consider flow resistance and sampling time requirements. This rational structural design ensures a stable gas flow state during the sampling process.

[0062] B-end structure:

[0063] Section B1: This section of pipe matches the diameter of the gas pipe section at end A, ensuring a smooth transition of gas within the T-shaped pipe. Its length and diameter help maintain pressure balance within the T-shaped gas path, allowing the gas to smoothly transition from end A to end B.

[0064] The second section, B2, achieves further fine-tuning and flow distribution of the gas through a reasonable pipe diameter variation. Its smaller diameter, working in conjunction with other sections, allows for precise adjustment of the gas flow through end B, thus achieving accurate flow distribution throughout the entire T-shaped gas path. Simultaneously, while meeting flow distribution requirements, the design of section B2 fully considers space utilization efficiency, making a significant contribution to minimizing the volume of end B.

[0065] Flow distribution principle: The T-shaped air duct consisting of ends A and B, through its designed diameter and length, and the differences in flow resistance between sections, achieves precise automatic flow distribution under the suction of the pump at end C. Under the condition that the total pumping rate remains constant, the flow rate through end A is made equal to the flow rate through end B through design and precise calculations. Simultaneously, while ensuring equal flow rates, the volume of end B is minimized through optimized design of each section of the duct.

[0066] Meanwhile, addressing the issue of excessive flow rate in the expiratory pump, the T-shaped airway design of this invention requires no additional load, allowing the flow rate to naturally stabilize within the ideal range of 1-3 mL / s. Figure 3 and Figure 4 As shown, by optimizing the diameter and length of the gas path, the flow resistance and pressure distribution of the gas in the pipeline are changed, thereby effectively controlling the expiratory flow rate. This design not only saves on the cost of additional loads but also simplifies the system structure, reduces potential failure points, and improves the stability and reliability of the entire expiratory breath detection system.

[0067] Building upon the aforementioned T-shaped airway distribution, it is also crucial to ensure that the expiratory pressure is stably maintained between 5-20 cmH2O as the gas flows through ends A and B during exhalation. This precise control of the pressure range meets the expiratory flow rate standards outlined in "ATS / ERS Recommendations for Standardized Procedures for the Online and Offline Measurement of Exhaled Lower Respiratory Nitric Oxide and Nasal Nitric Oxide, 2005," ensuring both patient comfort and the quality of exhaled air sample collection. This avoids the possibility that excessively high or low expiratory pressures could affect sampling accuracy and the reliability of test results.

[0068] This advanced flow distribution method is based on in-depth research and precise calculations of the T-shaped gas path fluid dynamics principle. This approach achieves device miniaturization while saving costs. Regardless of the testing scenario, it can stably and reliably collect highly representative exhaled breath samples, providing a strong guarantee for improving the accuracy of test results.

[0069] In a specific implementation, the intelligent exhalation algorithm specifically includes:

[0070] According to the ATS / ERS2005 technical standard, an adult must exhale for a standard 10 seconds during a single exhalation, with the first 6 seconds used to empty the dead space. Typically, the anatomical dead space volume for an adult is approximately 2.2 ml / kg; for example, a 70 kg adult would have an anatomical dead space of approximately 150 ml. The adult model algorithm design strictly adheres to this standard procedure.

[0071] However, breath sampling presents numerous challenges for children. Under the traditional ATS / ERS2005 technical standard, it takes 4 seconds to empty the dead space during a child's breath sampling. However, children's bodies are not yet fully developed, their breathing capacity is relatively weak, and their cooperation is often not as good as adults, making it extremely difficult to empty the dead space and accurately collect a breath sample within the prescribed 4 seconds.

[0072] To address this issue, this embodiment delves into the physiological characteristics of children and innovatively designs an intelligent exhalation algorithm based on multiple factors, including children's weight. Before a child uses this device for exhalation testing, the algorithm requires the patient to accurately input the child's weight information on a mobile app, while also recording the child's age data. The algorithm in this embodiment fully considers factors such as the child's weight and age to accurately calculate the maximum value of dead space air. The calculation formula is as follows:

[0073] Dead space maximum = weight * V + K * age;

[0074] Where V is the anatomical dead space volume per kilogram of body weight, and K is the correction factor.

[0075] The above formula fully considers the physiological differences between individual children, tailoring a dead space volume calculation method to suit each child's specific situation, thus more accurately guiding the exhalation process. Once the child begins to exhale, the device's built-in flow sensor monitors the expiratory flow rate in real time. Combining this with time information, the device dynamically and accurately calculates the volume of exhaled gas by integrating the flow rate curve over time. This real-time and precise monitoring method can sensitively capture every subtle change during the exhalation process.

[0076] Unlike the traditional fixed 4-second method for emptying dead space air, this algorithm makes intelligent decisions based on a comparison between the exhaled gas volume and the dead space air volume calculated according to weight and age. Once the calculated exhaled gas volume exceeds the dead space air volume calculated based on weight and age, the device automatically switches to the sampling phase. This intelligent exhalation algorithm accurately determines the time required to empty dead space air based on the unique differences of each child. Compared to the traditional fixed 4-second time, this significantly shortens the emptying time, effectively reducing the difficulty of exhalation for children, making the exhalation process easier and smoother, and thus more efficiently collecting accurate exhaled gas samples, significantly improving the accuracy and reliability of the detection. This innovative algorithm is particularly suitable for children under 8 years old or children with exhalation difficulties, providing a practical and efficient solution for exhalation testing in this special group.

[0077] In a specific implementation, the T-shaped air passage has the following specific structure:

[0078] First, install the nitric oxide sensor in the gas analysis channel and connect it to the temperature and humidity compensation device. Ensure that the gas analysis channel is well sealed and use high-precision sealing materials to prevent gas leakage and external interference.

[0079] Next, connect each part of end A in the predetermined connection sequence. Specifically, this includes the handle part A1 and the air tube part A2, and then tightly connect them to one end of the T-connector. During the connection process, use special sealing tools and materials to ensure that each connection point is tight and free of gas leakage.

[0080] For end B, the first air chamber B1 and the second tubing B2 are precisely connected and then connected to the other end of the T-connector, thus completing the T-shaped airway assembly of the exhalation sampling module. Throughout the assembly process of end B, the design of section B2 plays a crucial role in regulating the flow rate ratio between ends A and B.

[0081] Based on fluid mechanics principles and numerous experiments and theoretical calculations, when the pipe diameter of section B2 is d... B2 When the length is L B2 Given a total pumping speed of Q (unit: ml / s), the velocity ratio R between points A and B can be calculated using the following formula:

[0082]

[0083] Among them, Q A and Q B The traffic from endpoints A and B are respectively, r A2 r B1 r B2 Let A, B1, and B2 be the pipe radii, respectively, ΔP be the pressure difference between the two ends of the gas path, and μ be the dynamic viscosity of the gas.

[0084] Furthermore, after extensive experimental verification, to ensure that the flow rates at both ends A and B are as equal as possible while maintaining a constant total pumping speed, a pipe diameter range of 1.4-1.8 mm is recommended for section B2. Within this range, the flow velocity ratio at both ends A and B can be effectively controlled to approach 1:1, thereby meeting the device's precise requirements for flow distribution.

[0085] After completing the B-end assembly, a comprehensive airtightness check is performed on the entire gas circuit system to ensure there is no gas leakage.

[0086] Install the suction pump at end C, selecting a suitable pump (flow rate within the range of 1–3 ml / s). Precisely connect the pump to the gas lines at ends A and B, ensuring a tight connection free from twisting or blockage. Start the pump and, using a professional flow meter, measure the gas flow rate through ends A and B by simulating gas input at different flow rates and pressures. Ensure that, with a constant overall pumping rate, the flow rates at ends A and B are equal, and the expiratory pressure is stably maintained between 5–20 cmH2O.

[0087] After assembly, the exhalation sampling module is connected to the gas analysis channel to ensure that the exhaled gas sample can smoothly enter the gas analysis channel. The gas analysis channel has a built-in nitric oxide sensor. The signal transmission line is checked to ensure that the electrical signal output by the nitric oxide sensor can be accurately transmitted to the exhalation analysis module.

[0088] The breath analysis module consists of a microprocessor and a storage unit. The microprocessor is connected to the output of the nitric oxide sensor via a dedicated signal transmission line, enabling it to receive the electrical signal output by the sensor in real time. The microprocessor amplifies, filters, and performs analog-to-digital conversion on the received signal, and calculates the concentration of nitric oxide in the exhaled breath according to a preset algorithm. The storage unit stores the detection data and calibration parameters, ensuring secure data storage and rapid retrieval.

[0089] In a specific embodiment, a household portable exhaled nitric oxide analyzer includes the following operating steps:

[0090] In the intelligent interaction module, a diaphragm sensor is installed on a specific area of ​​the casing surface to sense pressure changes caused by placing the phone on it. The NFC and Bluetooth modules ensure near-field communication and a stable connection with the phone, while the voice module provides operation prompts, ensuring that the user can clearly hear the voice prompts during the testing process.

[0091] In practice, patients need to ensure that the corresponding app is installed on their mobile phone and that NFC and Bluetooth functions are enabled before using the device. The disposable mouthpiece is then attached to the exhalation port on the handle portion of the A-end. The phone is then placed on a specific area of ​​the device's outer shell. Once the diaphragm sensor detects the phone's weight, the device automatically powers on, the NFC module establishes near-field communication with the phone, and the phone screen automatically redirects to the corresponding app's testing interface.

[0092] The patient takes a deep breath following the voice prompts on the mobile app, followed by a sustained exhalation of 10 seconds. The exhaled air enters the T-connector through the A-end tube, and the device's built-in pressure sensor monitors the expiratory pressure in real time. When the pressure rises to a preset threshold (e.g., 5 cm of water column), the pump starts, drawing gas from both ends A and B to form a stable T-shaped airway. The first 6 seconds of exhalation are for emptying dead space gas; afterwards, the device automatically switches to the sampling phase, and the exhaled air sample enters the gas analysis channel through the T-shaped airway.

[0093] The nitric oxide sensor detects the concentration of nitric oxide in exhaled breath. Electrodes on the sensor surface undergo an electrochemical reaction with nitric oxide, generating an electrical signal proportional to the nitric oxide concentration. This signal is transmitted to a microprocessor via a dedicated signal transmission line. The microprocessor calculates the concentration of nitric oxide in exhaled breath according to a preset algorithm and transmits the detection data to a mobile app via Bluetooth. Patients can view the test results and related health advice on the app.

[0094] The device is designed to ensure stability and accuracy under different environmental conditions, and can effectively detect the concentration of nitric oxide in the user's exhaled breath, providing a convenient solution for health monitoring.

[0095] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on its differences from other embodiments. Similar or identical parts between embodiments can be referred to interchangeably. For the apparatus disclosed in the embodiments, since they correspond to the methods disclosed in the embodiments, the description is relatively simple; relevant parts can be referred to the method section.

[0096] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those 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 invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A household portable exhaled nitric oxide analyzer, characterized in that, include: Intelligent interaction module, breath sampling module, breath analysis module, and wireless transmission module; The intelligent interaction module is used to wirelessly connect to the terminal. The exhalation sampling module uses a T-shaped air passage, with one end for the patient to exhale and inhale, the other end for the patient to exhale and expel air, and the third end connected to the exhalation analysis module via an analysis pump. The exhalation analysis module is used to analyze and calculate the sampled gas using an intelligent exhalation algorithm; The wireless transmission module is used to upload the analysis results to the terminal.

2. The household portable exhaled nitric oxide analyzer according to claim 1, characterized in that, The intelligent interaction module includes a diaphragm sensor, an NFC module, a Bluetooth module, and a voice module. The NFC module and the Bluetooth module are both connected to the terminal signal. The terminal is placed on the diaphragm sensor, which is used to sense pressure changes caused by the placement of the terminal. The voice module is used to provide voice operation prompts.

3. A household portable exhaled nitric oxide analyzer according to claim 1, characterized in that, The intelligent exhalation algorithm includes: Dead space maximum = weight * V + K * age; Where V is the anatomical dead space volume per kilogram of body weight, and K is the correction factor.

4. A household portable exhaled nitric oxide analyzer according to claim 1, characterized in that, The T-shaped airflow pipe includes: an A-end structure, a B-end structure, a C-end structure, and a T-shaped connector. The A-end structure, B-end structure, and C-end structure are connected by the T-shaped connector. The C-end structure includes a gas analysis channel, a suction pump, and an exhalation analysis module connected in sequence. The A-end structure includes a handle portion A1 and a tubing portion A2 connected in sequence. The B-end structure includes a first section of tubing B1 and a second section of tubing B2 connected in sequence. The gas flow rate through the B-end structure is adjusted by adjusting the diameter of the A-end structure and the B-end structure, thereby distributing the flow rate of the T-shaped airflow pipe.

5. A household portable exhaled nitric oxide analyzer according to claim 4, characterized in that, The diameter of the first section of pipe B1 matches that of the tracheal section A2.

6. A household portable exhaled nitric oxide analyzer according to claim 4, characterized in that, Also includes: A pressure sensor is installed on the inner wall of the T-connector to detect the pressure of exhaled gas as it enters the T-connector through the A-end structure.

7. A household portable exhaled nitric oxide analyzer according to claim 4, characterized in that, The method of adjusting the gas flow rate through the B-end structure by adjusting the pipe diameters of the A-end and B-end structures, thereby distributing the flow rate of the T-shaped gas pipeline, includes: The diameter of the second section of pipe, B2, is d. B2 The length is L B2 The length of segment A2 of the trachea is L. A2 The length of the first pipe section B1 is L. B1 ; When the total pumping speed of the pump is Q, the velocity ratio R at both ends of structures A and B is expressed as: Among them, Q A and Q B The flow rates of the A-end structure and the B-end structure are respectively, r A2 r B1 r B2 The radii are the pipe radii of section A2 of the trachea, section B1 of the first pipe, and section B2 of the second pipe, respectively. ΔP is the pressure difference between the two ends of the gas path, and μ is the dynamic viscosity of the gas.

8. A household portable exhaled nitric oxide analyzer according to claim 1, characterized in that, The exhalation sampling module also includes a nitric oxide sensor, which is signal-connected to the exhalation analysis module.

9. A household portable exhaled nitric oxide analyzer according to claim 8, characterized in that, The exhaled breath analysis module includes a microprocessor and a storage unit. The microprocessor is connected to the nitric oxide sensor signal. The microprocessor is used to amplify, filter, and perform analog-to-digital conversion on the received signal, and to calculate the concentration of nitric oxide in the exhaled breath according to a preset algorithm. The storage unit is used to store detection data and calibration parameters for data storage and rapid retrieval.

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