CN115902079A - Exhaled air analysis device and method - Google Patents
Exhaled air analysis device and method Download PDFInfo
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- CN115902079A CN115902079A CN202110944772.0A CN202110944772A CN115902079A CN 115902079 A CN115902079 A CN 115902079A CN 202110944772 A CN202110944772 A CN 202110944772A CN 115902079 A CN115902079 A CN 115902079A
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Abstract
The invention discloses an exhaled breath analysis device, which comprises a sampling assembly, a detection assembly and a data analysis assembly, wherein the sampling assembly is used for sampling exhaled breath; the system comprises a collecting component, a data analyzing component, a data processing component and a data processing component, wherein the collecting component is used for collecting and transmitting all exhaled breath to the detecting component in real time, the detecting component is used for detecting all the exhaled breath in real time so as to determine all components and corresponding concentrations of the exhaled breath, the data analyzing component is used for recording the components and the concentrations of the exhaled breath and the changes of the exhaled breath along with time, original detection data are formed, then a breathing cycle is identified according to characteristic information obtained from the original detection data, each breathing cycle is divided into at least two breathing stages, non-full-cycle data of at least one breathing stage are extracted from the original data to serve as effective data, and then the effective data are further processed so as to evaluate whether an exhaled breath donor is in a specific medical state or not. The exhaled breath analysis device can carry out full-component and high-fidelity real-time detection on exhaled breath, automatically identifies breathing cycles and stages according to detection data, and can simultaneously and accurately detect various diseases based on the detection data of different breathing stages.
Description
Technical Field
The present invention relates to an exhaled breath analysis apparatus and method, and more particularly, to an exhaled breath analysis apparatus and method for health status assessment and disease diagnosis based on biomarkers in exhaled breath.
Background
The exhaled air contains not only the well-known components of oxygen, nitrogen, carbon dioxide and water vapor, but also thousands of trace amounts of Volatile Organic Compounds (VOCs), which are the products of metabolism of various organs and cells of the human body and directly reflect the health and disease states of the human body. The history of disease diagnosis based on exhaled breath has been long, and doctors in ancient times of the way and doctors in traditional Chinese medicine "hear and ask" can diagnose diseases by the characteristic smell in exhaled breath of patients. Through long-term medical practice, doctors can easily distinguish fruity (ketones), "musty", "fishy", "urine" and "putrefactive" odors in the breath of patients with diabetes, end-stage liver disease, renal failure and lung abscess. Professor Linus Pauling, nobel prize-winning in the 1970's, used gas chromatography to detect 250 VOCs in human exhaled breath (PNAS, 1971,68 (10), 2374-2376). Since then more and more research teams around the world have started the study of exhaled breath, and currently, exhaled breath metabolomics has been developed. The pattern recognition is carried out on the atlas formed by hundreds of exhaled breath VOCs, more than ten diseases can be diagnosed at the same time, and the accuracy of diagnosis can be further improved and the indications can be enlarged by combining medical big data and artificial intelligence technology. Research related to exhaled breath detection has advanced over 50 years and the relevance of exhaled breath VOCs to disease has become increasingly clear and definite. The Human expiratory databases (Human breath Database) are currently the most comprehensive knowledge base of Human exhaled breath, and record at least 2766 references, 913 potential biomarkers of VOCs and 60 exhaled breath-related diseases, which are supported by hundreds of thousands of clinical samples.
There are many possible sources of VOCs in exhaled human breath, which can be roughly divided into two categories: endogenous VOCs and exogenous VOCs. Endogenous VOCs are primarily products of metabolic activity in the lungs, respiratory tract, and even throughout the body. Endogenous VOCs reach the lung through blood circulation and then enter the respiratory tract from the alveoli through blood-gas exchange to be exhaled out of the body. Therefore, the detection of endogenous VOCs in exhaled breath is a rapid and noninvasive detection method, and can be used for performing systemic and systemic detection on the health state of a human body. Exogenous VOCs are the result of external environments/factors such as metabolites of microbes in the body, exposure to specific external environments, and dietary, smoking, and drug intake. These external factors have direct and indirect effects on human health and are also of great medical research value.
Currently, researchers have developed many different detection techniques for detecting exhaled breath in humans, including Gas Chromatography-Mass Spectrometry (GCMS), proton Transfer Reaction-Mass Spectrometry (PTR-MS), selective Ion Flow Tube-Mass Spectrometry (SIFT-MS), ion Mobility Spectrometry (IMS), and electronic nose (E-nose). Different detection techniques have advantages in terms of sensitivity, specificity, multi-component identification, assay throughput, cost, ease of use, and the like. Although there are thousands of VOCs in exhaled breath, they are present mostly in trace amounts at concentrations between ppt and ppb. There is an extremely complex association and correspondence between these numerous VOCs and a wide variety of diseases, and there is currently no clear evidence of what the different types of exhaled VOCs differ between healthy and diseased populations, primarily by differences in the concentrations of certain VOCs. Especially for complex diseases like cancer, the potential biomarkers of VOCs are several, even dozens of, more. Accurate quantitative and qualitative analysis of the VOCs directly determines the accuracy of disease state discrimination. In addition to the various detection techniques described above, the technique of sampling exhaled breath is also important for accurate identification of exhaled breath VOCs.
At present, the existing exhaled breath sampling technology is eight-fold, and the variety is various, including various sampling containers made of different materials, different sampling time and duration, and selective adsorption of VOCs of specific categories. These sampling techniques are essentially designed to collect and enrich as much as possible specific target VOCs, while filtering out interference from other substrates to improve detection sensitivity and signal-to-noise ratio. For example, US11033203 discloses a portable exhaled air off-line sampling device for collecting a part of samples from exhaled air of a patient, which senses the internal gas pressure of a sampler through a pressure sensor, samples the samples through a sampling pump after a predetermined threshold value is exceeded, adsorbs corresponding exhaled air samples through an adsorption material, and then sends the collected samples to a detection device for detection. The method can enrich specific components in the exhaled breath and provide sensitivity of subsequent detection, but not only loses information of gas components in the exhaled breath, but also does not record time information related to respiration, thereby influencing the application range and the accuracy and reliability of detection. U.S. Pat. No. 11026596 discloses a method for detecting tetrahydrocannabinol in exhaled breath, which comprises the steps of adding a fluorescent label to the tetrahydrocannabinol through specific binding, activating the fluorescent label, and detecting the fluorescence intensity to complete the detection of the tetrahydrocannabinol. This method helps to enhance the specificity and sensitivity of detection, however, it is limited to the detection of target substances and the number of target substances that can be detected simultaneously is very limited.
However, these sampling methods are inherently impossible to collect and send the VOCs in the exhaled breath to the detection apparatus for detection with high fidelity and no loss of the same kind or concentration of VOCs in all exhaled breath, which not only affects the relative concentration of various VOCs in the detection results, but also results in many VOCs being selectively lost. In the case that the target biomarker is not clear enough, the accuracy and stability of the detection result can be greatly influenced by such a sampling mode. Therefore, the invention provides a full-component exhaled breath detection technology and method capable of collecting and detecting exhaled breath in real time, which avoids the influence of the sampling process on the components and the concentration of the exhaled breath VOCs to any extent, obtains the detection result of the full-component exhaled breath, and analyzes the detection result according to the actual requirement to cut and combine the detected VOCs data so as to realize the simultaneous, efficient and accurate detection of various diseases.
Disclosure of Invention
In view of the above-described drawbacks of the prior art, it is an object of the present invention to provide an exhaled breath analyzing apparatus including a sampling component, a detection component, and a data analyzing component; the collection assembly is used for collecting and transmitting all exhaled breath to the detection assembly in real time, the detection assembly is used for detecting all the exhaled breath in real time to determine all components and corresponding concentrations of the exhaled breath, the data analysis assembly is used for recording the components and the concentrations of the exhaled breath and changes of the exhaled breath along with time to form original detection data, then a breathing cycle is identified according to characteristic information obtained from the original detection data, each breathing cycle is divided into at least two breathing stages, non-full-cycle data of at least one breathing stage is extracted from the original data to serve as effective data, and then the effective data are further processed to evaluate whether an exhaled breath donor is in a specific medical state or not. The exhaled breath analysis device can detect all components of exhaled breath in real time, automatically identify breathing cycles and stages according to detection data, and accurately detect multiple diseases simultaneously based on the detection data of different breathing stages.
In order to achieve the above and other related objects, the present invention provides an exhaled breath analyzing apparatus, including a collecting component, a detecting component and a data analyzing component, wherein the collecting component is configured to collect and transmit all exhaled breath to the detecting component in real time, the detecting component detects all the exhaled breath collected in real time to determine its components and corresponding concentrations, the data analyzing component is configured to record the components and concentrations of the exhaled breath and their changes over time, form raw detection data, identify a breathing cycle according to characteristic information obtained from the raw detection data and divide each breathing cycle into at least two breathing stages, extract non-full-cycle data of at least one breathing stage from the raw data as valid data, and further process the valid data to evaluate whether an exhaled breath donor is in a specific medical state.
Further, according to the exhaled breath analysis apparatus described above, wherein: the collection assembly is connected with the detection assembly and the data analysis assembly, no intermediate storage and transfer process is needed in the collection process of the exhaled breath, the exhaled breath can be continuously transmitted to the downstream detection assembly in real time, the detection assembly continuously and uninterruptedly works, not only can be used for detecting the composition and concentration of the exhaled breath in real time, but also can be used for monitoring the change of the composition/concentration of the exhaled breath along with time, the downstream data analysis assembly firstly records complete time flow information, and the information of each time point comprises but is not limited to the composition information in the exhaled breath, the concentration information of each composition, the total concentration information of all the compositions and the like. All the above information is saved as raw detection data and processed in the next step. Further, the data analysis component extracts characteristic information from the primary detection data through primary analysis to identify a complete breathing cycle, and divides the breathing cycle into at least two breathing phases. The detection data corresponding to different breathing stages have different application values, and the non-full-period data of at least one breathing stage is extracted from the original data as effective data according to actual conditions. Whether the donor of the exhaled breath is in a certain medical state can be assessed by further advanced analysis of the valid data. The high-level analysis includes but is not limited to data format conversion, artificial intelligence algorithm processing, database retrieval and matching, and the like.
It is worth mentioning that different valid data can be repeatedly extracted from the original data that has been permanently recorded according to the subsequent different medical condition assessment requirements. Meanwhile, the original data comprises the exhaled breath detection information of all components, so that the exhaled breath analysis device provided by the invention can realize more and more accurate medical state evaluation than the existing detection mode.
The exhaled breath analysis apparatus according to the above, wherein: the collection assembly includes a carrier gas component for delivering volatile components in the exhaled breath and a filter component for filtering out non-volatile components in the exhaled breath.
Further, according to the exhaled breath analysis apparatus described above, wherein: the carrier gas part in the collection assembly carries the expired gas by using high-purity inert gas, such as nitrogen, argon, helium and the like with the purity of not less than 99.99%; the filter component filters dust, aerosol, microorganism particles, nucleic acid, protein, non-volatile molecules, water vapor and the like in carrier gas and/or exhaled air based on the principles of adsorption, condensation, size exclusion and the like, so that the pollution to a downstream analysis device is reduced, the maintenance requirement of the device is reduced, and the memory effect is avoided, and the detection result and performance are prevented from being interfered.
The exhaled breath analysis apparatus according to the above, wherein: the detection component is one or a combination of mass spectrum, chromatogram and ion mobility spectrometry.
Further, according to the exhaled breath analysis device, the detection component is an independent analysis technology of chromatography, mass spectrometry and ion mobility spectrometry, the system structure is simple, and the cost is low; on the other hand, the detection component can also be a chromatography-mass spectrometry technology, an ion mobility spectrometry-mass spectrometry technology, a chromatography-ion mobility spectrometry technology and a chromatography-ion mobility spectrometry-mass spectrometry technology, so that the qualitative and quantitative capabilities can be greatly improved, and the accuracy of the detection result is greatly improved.
The exhaled breath analysis apparatus according to the above, wherein: the exhaled breath comprises volatile organic compounds and/or volatile inorganic compounds.
The exhaled breath analysis apparatus according to the above, wherein: the characteristic information is the signal response of carbon dioxide in the exhaled breath and/or the signal response of all components in the exhaled breath.
Further, the characteristic information includes, but is not limited to, carbon dioxide (CO) 2 ) Concentration of (d), oxygen (O) 2 ) Concentration of single or multiple VOCs, total concentration information for all components, etc.
The exhaled breath analysis apparatus according to the above, wherein: the exhaled air donor is human, murine, feline, canine, poultry, livestock, equine, and other animals.
The exhaled breath analysis apparatus according to the above, wherein: the medical condition is one or a combination of a health condition, cancer, infectious disease, metabolic abnormality disease, exposure experience to a specific environment.
As described above, the exhaled breath analysis device according to the present invention has the following advantageous effects:
[1] collecting and detecting a full-component high-fidelity exhaled breath sample;
[2] no additional special device is needed to identify the breathing cycle and the breathing phase;
[3] simultaneous high-accuracy detection of multiple medical conditions;
drawings
FIG. 1 is a schematic diagram of an exemplary structure of an exhaled breath analysis apparatus according to the present invention
FIG. 2 is a schematic view of an exhaled breath analysis apparatus according to the preferred embodiment of the present invention
FIG. 3 is a schematic diagram showing the division of respiratory cycles and respiratory phases revealed based on the change in the carbon dioxide concentration in exhaled breath over time
Detailed Description
The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope of the present invention.
It should be noted that the drawings provided in the present embodiment are only schematic and illustrate the basic idea of the present invention, and although the drawings only show the components related to the present invention and are not drawn according to the number, shape and size of the components in actual implementation, the form, quantity and proportion of the components in actual implementation may be changed arbitrarily, and the layout of the components may be more complicated.
The exhaled breath analysis device of the present invention is an exhaled breath analysis device that performs real-time, all-component collection, detection, and analysis of exhaled breath, and can be used for health status assessment, disease diagnosis, treatment effect assessment, prognosis monitoring, and the like.
The exhaled breath analyzing device comprises a collecting component, a detecting component and a data analyzing component, wherein the collecting component is used for collecting and transmitting all exhaled breath to the detecting component in real time, the detecting component is used for detecting all the collected exhaled breath in real time to determine components and corresponding concentrations of the exhaled breath, the data analyzing component is used for recording components and concentrations of the exhaled breath and changes of the components and concentrations along with time to form original detection data, then a breathing cycle is identified according to characteristic information obtained from the original detection data, each breathing cycle is divided into at least two breathing stages, non-full-cycle data of at least one breathing stage is extracted from the original data to serve as effective data, and then the effective data are further processed to evaluate whether an exhaled breath donor is in a specific medical state. The exhaled breath analysis device can collect and detect exhaled breath samples with full components and high fidelity, does not need additional special devices for identifying the breathing cycle and the breathing stage, and can realize high-accuracy detection of various medical states.
Example one
Fig. 1 is a schematic view showing a typical structure of an exhaled breath analysis apparatus according to the present disclosure. As shown in the drawings, the exhaled breath analyzing apparatus disclosed in the present invention includes an exhaled breath collecting module 101, an exhaled breath detecting module 102, and a data analyzing module 103. Fig. 2 is a schematic view of a preferred embodiment of the exhaled breath analysis apparatus. As shown in fig. 2, the exhaled breath analyzing apparatus disclosed in the present invention typically operates by collecting and transmitting 201 the exhaled breath from the exhaled breath collecting module 101 to the downstream exhaled breath detecting module 102, completing real-time detection of components and concentrations in the exhaled breath 202, recording data of the detected components and concentrations in the exhaled breath and changes thereof at any time by the data analyzing module 103, obtaining raw data 203, identifying a breathing cycle according to characteristic information in the raw data, dividing the breathing cycle into at least two breathing stages 204, extracting non-full-cycle data of at least one breathing stage from the raw data according to requirements of specific detection targets to obtain valid data 205, and finally further processing the valid data to evaluate whether the exhaled breath donor is in a specific medical state 206.
Preferably, the collection assembly includes a carrier gas component that uses a high purity carrier gas, such as 99.999% nitrogen, as a carrier to transport volatile organics and volatile inorganics in the exhaled breath. Regarding the selection of the carrier gas, on one hand, a gas with high chemical inertness is preferably selected, so that the carrier gas does not react with the potential compounds in the exhaled breath, and the detection result is ensured to be correct, and on the other hand, the use cost and the use safety of the carrier gas are also considered factors. In addition to nitrogen, helium, argon, specially prepared compressed air, filtered natural air, etc. may be used as the carrier gas. In addition, since the flow rate of the exhaled breath is constantly changing during the breathing process, the flow rate of the carrier gas should be much higher than the average flow rate of the exhaled breath in order to ensure the operational stability of the downstream detection assembly. Meanwhile, the carrier gas can quickly wash the exhaled air components remained on the acquisition assembly, so that the interference on the next detection is avoided. Preferably, the carrier gas flow rate is any one of 0 to 2 liters/minute, or 3 to 6 liters/minute, or 7 to 10 liters/minute, or 11 to 20 liters/minute.
Preferably, the collection component comprises a filter element for filtering out non-volatile components in the exhaled breath, and the filter element is used for filtering out dust, aerosol, microorganism particles, nucleic acids, proteins, non-volatile molecules, water vapor and the like in the carrier gas and/or the exhaled breath based on the principles of adsorption, condensation, size exclusion and the like, so as to reduce pollution to a downstream analysis device, reduce the maintenance requirement of the device, and avoid memory effect and interference with the detection result and performance.
Optimally, the detection component is an independent analysis technology of chromatography, mass spectrum and ion mobility spectrometry, the system structure is simple, and the cost is low; meanwhile, in order to improve the qualitative and quantitative capability and the accuracy of the detection result, the detection component can also be a chromatography-mass spectrometry technology, or an ion mobility spectrometry-mass spectrometry technology, or a chromatography-ion mobility spectrometry-mass spectrometry technology. More preferably, the detection component is an ion mobility spectrometry-mass spectrometry combined technology, so that not only can the optimal qualitative and quantitative capability of exhaled breath detection be ensured, but also very quick real-time analysis can be realized, and the detection flux can be ensured.
Preferably, the exhaled breath is composed of volatile organic compounds or volatile inorganic compounds. Generally, these volatile organic or inorganic compounds have a boiling point of 50 to 260 degrees celsius at normal temperature and a relative molecular mass of less than 1000Da (daltons, atomic mass units).
Preferably, the characteristic information is carbon dioxide (CO) in exhaled breath 2 ) Or oxygen (O) 2 ) Or the concentration of single and multiple VOCs, or the total concentration of all components. Under normal circumstancesThe characteristic information can change regularly with time and is basically consistent with the breathing rhythm, so that the breathing process can be directly reflected. As shown in FIG. 3, the successive respiratory cycles 300-T1, 300-T2 and 300-Tn are depicted as the change in the concentration of carbon dioxide in exhaled breath, while each respiratory cycle can be divided into 4 phases, namely: inspiration 301, expiration rise 302, expiration plateau 303, and expiration fall 304. The inspiratory phase 301 essentially detects only baseline data, and can serve as a control as well as a segmentation boundary for adjacent respiratory cycles, generally without practical significance to the detection result. The air in the natural environment contains about 78% nitrogen, 20.9% oxygen and 1.1% other gases. After inhalation, the body converts some of the oxygen to carbon dioxide and deposits in the alveoli at the bottom of the lungs, a portion of the gas called the end-tidal sample or alveolar gas. Approximately 6% of the oxygen will be converted to carbon dioxide, resulting in alveolar gas containing approximately 14% oxygen and 6% carbon dioxide, as well as volatile organic and volatile inorganic species. In addition, there are also some gases present in the respiratory tract, and gases that diffuse from the digestive tract to the respiratory tract, collectively known as dead space gases. The expiratory phase 302 is generally a mixture of dead space gas and alveolar gas; the expiratory plateau phase 303 is essentially all alveolar gas; while the duration of the expiratory descent phase 304 is very short, rapidly descending to baseline and entering the next respiratory cycle. The sources of the dead space gas and the alveolar gas are different, and different life health activities and states are reflected, so that the data information acquired in the expiration rising stage 302, the expiration platform stage 303 and the expiration falling stage 304 is reasonably applied to further data processing and analysis, and the medical states of health/diseases and the like of an expired air donor can be more accurately and reliably disclosed.
Preferably, the further data processing and analysis includes, but is not limited to: data denoising processing, baseline correction processing, peak alignment processing, normalization processing, principal component analysis algorithm analysis, fuzzy logic algorithm analysis, database retrieval and matching and the like.
More preferably, the medical conditions include, but are not limited to: health status, cancer, infectious diseases, metabolic disorders, and exposure to specific environments.
Preferably, the donor of exhaled breath includes, but is not limited to, humans, rodents, cats, dogs, poultry, livestock, and other animals such as horses.
In summary, the exhaled breath analysis apparatus disclosed by the present invention has a simple structure, does not need additional special devices to identify the respiratory cycle and the respiratory phase, and can perform high fidelity acquisition and detection on the full-component exhaled breath samples, so that various medical conditions can be detected at the same time with high accuracy, various defects in the prior art are effectively overcome, and the apparatus has a high industrial utilization value.
The foregoing embodiments are merely illustrative of the principles of the present invention and its efficacy, and are not to be construed as limiting the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and scope of the present invention as defined in the appended claims.
Claims (8)
1. An exhaled breath analyzing apparatus, characterized in that,
comprises an acquisition component, a detection component and a data analysis component,
the collecting component is used for collecting and transmitting all the exhaled air to the detecting component in real time,
the detection assembly detects all the exhaled breath collected in real time to determine the components and the corresponding concentrations thereof,
the data analysis component is used for recording the components and concentration of the exhaled breath and the change of the exhaled breath along with time, forming original detection data, identifying breathing cycles according to characteristic information obtained from the original detection data, dividing each breathing cycle into at least two breathing stages, extracting non-full-cycle data of at least one breathing stage from the original data as effective data, and further processing the effective data to evaluate whether an exhaled breath donor is in a specific medical state.
2. The exhaled breath analysis apparatus of claim 1, wherein the collection component comprises a carrier gas component for transporting volatile components in the exhaled breath and a filter component for filtering out non-volatile components in the exhaled breath.
3. The exhaled breath analysis apparatus of claim 1, wherein the detection component is one or a combination of mass spectrometry, chromatography, ion mobility spectrometry.
4. The exhaled breath analysis apparatus according to claim 1, wherein the exhaled breath is composed of volatile organic compounds and/or volatile inorganic compounds.
5. The exhaled breath analysis apparatus according to claim 1, wherein the characteristic information is a signal response of carbon dioxide in the exhaled breath and/or a signal response of all components in the exhaled breath.
6. The exhaled breath analysis apparatus according to claim 1, wherein the exhaled breath donor is a human, a mouse, a cat, a dog, poultry, livestock, or a horse.
7. The exhaled breath analysis device of claim 1, wherein the medical condition is one or a combination of a health condition, cancer, an infectious disease, a metabolic abnormality disease, an exposure history of a specific environment.
8. An exhaled breath analysis method, comprising the steps of:
collecting and transmitting all exhaled air to the detection assembly in real time by using the collection assembly;
detecting all the collected exhaled breath in real time by using a detection assembly to determine each component and corresponding concentration of the exhaled breath;
the method comprises the steps of recording the composition and concentration of exhaled breath and the change of the exhaled breath with time by using a data analysis component, forming original detection data, identifying breathing cycles according to characteristic information obtained from the original detection data, dividing each breathing cycle into at least two breathing stages, extracting non-full-cycle data of at least one breathing stage from the original data as effective data, and further processing the effective data to evaluate whether an exhaled breath donor is in a specific medical state.
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