KR20240125202A - Apparatus of exhaled-breath analysis and lung capacity measurement for lung diseases screening - Google Patents

Abstract

The present invention relates to an exhalation analysis and spirometry device for screening for lung diseases, and is characterized by including: first, second, and third 3-way valves forming a path for exhaled gas; a sampling loop connected between the first and second 3-way valves; a flow sensor measuring a flow rate of exhaled gas discharged from the second 3-way valve; a sensor analyzing exhaled gas discharged from the third 3-way valve; a processor controlling the path for exhaled gas by switching the first to third 3-way valves according to an operation mode; and a pump which, in an alveolar gas extraction and analysis mode, causes exhaled gas stored in the sampling loop to flow toward the sensor by drawing in outside air.

Description

{APPARATUS OF EXHALED-BREATH ANALYSIS AND LUNG CAPACITY MEASUREMENT FOR LUNG DISEASES SCREENING}

The present invention relates to an expiratory analysis and spirometry device for noninvasively screening for lung diseases, and more specifically, to an expiratory analysis and spirometry device for screening for lung diseases, which extracts alveolar gas in expiratory air, analyzes the gas components thereof, and simultaneously measures lung capacity by measuring the flow rate of expiratory air.

Spirometry devices typically measure the volume and flow rate of air that a person begins to exhale. The above spirometry is important for general physiological studies and for diagnostic interpretation of specific patients.

For example, human breath contains various bio-information about health and disease, and it is known that periodontal disease, fat burning, diabetes, lung cancer, pulmonary tuberculosis, asthma, kidney disease, colon disease, and Alzheimer's disease can be roughly diagnosed using biomarker analysis technology for various volatile organic compounds (VOCs) emitted in exhaled breath.

The above exhaled gas refers to gas discharged through the oral cavity or nasal cavity during exhalation during the respiration of the human body, and contains various gas components related to metabolism of the human body, etc. Therefore, the exhaled gas analysis device is a device that analyzes such exhaled gas, measures the components and concentrations of specific gases in the exhaled gas, and can make rough estimates of human diseases, etc. using the measured values.

However, conventional breath analysis devices have been developed only to the extent of analyzing the components of gas generated in the oral cavity related to bad breath, etc., and gas generated in the bronchial tubes related to asthma, etc., and it is impossible to analyze the components of alveolar gas generated in the deep lungs related to lung disease. In addition, there is a problem that a separate spirometric device must be additionally used to measure lung function such as expiratory volume, lung capacity, and lung volume for additional lung disease screening.

The background technology of the present invention is disclosed in Korean Patent No. 10-2465031 (registered on November 4, 2022, personal portable spirometry device and method).

According to one aspect of the present invention, the present invention has been created to solve the above problems, and the purpose of the present invention is to provide an expiratory analysis and spirometry device for screening for lung diseases, which can extract alveolar gas in expiratory air, analyze the gas components thereof, and measure lung capacity by measuring the flow rate of expiratory air at the same time.

According to one aspect of the present invention, an expiratory analysis and spirometry device comprises: first, second, and third 3-way valves forming a path for exhaled gas; a sampling loop connected between the first and second 3-way valves; a flow sensor measuring a flow rate of exhaled gas discharged from the second 3-way valve; a sensor analyzing exhaled gas discharged from the third 3-way valve; a processor controlling the path for exhaled gas by switching the first to third 3-way valves depending on an operation mode; and a pump which, in an alveolar gas extraction and analysis mode, causes exhaled gas stored in the sampling loop to flow toward the sensor by drawing in outside air.

According to one aspect of the present invention, the present invention enables measurement of lung capacity by analyzing gas components in expired air and simultaneously measuring the flow rate of expired air.

In addition, the present invention enables noninvasive screening of lung diseases by extracting and analyzing alveolar gas components related to lung diseases in expired (exhaled) gas.

Figure 1 is an exemplary diagram illustrating an example of use of a spirometry device and an expiratory analysis device to which the present invention can be applied.
FIG. 2 is an exemplary diagram showing a schematic configuration of an expiratory analysis and spirometry device according to one embodiment of the present invention.
FIG. 3 is an exemplary diagram for explaining how the expiratory analysis and spirometry device of FIG. 2 operates in spirometry mode.
FIG. 4 is an example diagram showing more specifically the switching states of the first to third 3-way valves in the lung capacity measurement mode in FIG. 3.
FIG. 5 is an exemplary diagram for explaining how the expiratory analysis and spirometry device of FIG. 2 operates in the alveolar gas extraction and analysis mode.
FIG. 6 is an example diagram showing more specifically the switching states of the first to third 3-way valves in the alveolar gas extraction and analysis mode in FIG. 5.

Hereinafter, with reference to the attached drawings, an embodiment of an expiratory analysis and spirometry device for lung disease screening according to the present invention will be described. In this process, the thickness of lines and the size of components illustrated in the drawings may be exaggerated for clarity and convenience of explanation. In addition, the terms described below are terms defined in consideration of functions in the present invention, and these may vary depending on the intention or custom of the user or operator. Therefore, the definitions of these terms should be made based on the contents throughout this specification.

Figure 1 is an exemplary diagram illustrating an example of using a spirometry device and an expiratory analysis device to which the present invention can be applied. Figure 1 (a) is an exemplary diagram illustrating a situation in which a spirometry device is used, and Figure 1 (b) is an exemplary diagram illustrating a situation in which an expiratory analysis device for screening asthma is used.

As shown in Figure 1, when a user blows air into the mouthpiece, the flow rate or gas composition of the exhaled air is analyzed to screen for lung diseases.

In the case of a spirometry device as shown in (a) of Fig. 1, the flow rate of exhaled air is detected to measure expiratory volume, lung capacity, and lung volume, and in the case of an expiratory analysis device as shown in (b) of Fig. 1, the gas components of exhaled air are analyzed to screen for the degree of asthma.

At this time, in order to screen for lung diseases such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and pneumonia, alveolar gas components generated deep inside the lungs must be extracted and analyzed. However, in order to analyze alveolar gas components generated deep inside the lungs as described above, appropriate flow control and sampling techniques are required.

In addition, if additional spirometry is performed to increase the accuracy of the above lung disease screening, there is a problem in that a separate spirometry device must be used, which causes inconvenience and additional costs.

Accordingly, the expiratory analysis and spirometry device according to the present embodiment has the characteristic of resolving the above problem (i.e., the problem of having to use a separate device to measure spirometry and analyze alveolar gas components) by simultaneously analyzing gas components in expiratory air and measuring expiratory flow rate to measure expiratory air capacity.

FIG. 2 is an exemplary diagram showing a schematic configuration of an expiratory analysis and spirometry device according to one embodiment of the present invention.

As illustrated in FIG. 2, the expiratory analysis and spirometry device according to the present embodiment includes a gas inlet (110), a first filter (120), a first 3-way valve (130), a sampling loop (140), a second 3-way valve (150), first and second flow sensors (160, 260), a second filter (210), a third 3-way valve (220), a Nafion tube (230), a NO (nitrogen monoxide) sensor (240), a temperature and humidity sensor (250), a pump (270), and a processor (300).

The above processor (300) controls the flow path (direction of fluid flow) of the first to third 3-way valves (130, 150, 220) according to the operation mode (e.g., spirometry mode, alveolar gas extraction/analysis mode) of the expiratory analysis and spirometry device according to the present embodiment.

The above first to third 3-way valves (130, 150, 220) use 3-port solenoid valves to switch the flow direction (direction of fluid flow) according to the control of the processor (300).

The above first filter (120) filters out saliva or foreign substances contained in the exhaled breath of the user through the gas inlet (110).

The above second filter (210) filters out dust and foreign substances contained in the outside air.

The above sampling loop (140) is formed in a rounded shape with a long tube (or pipe) to sample gas, and in this embodiment, stores alveolar gas discharged at the end of expiration.

The above Nafion tube (230) is formed of a material that absorbs moisture, thereby reducing the humidity of alveolar gas discharged to the NO (nitrogen monoxide) sensor (240).

The above pump (270) draws in outside air and maintains a constant flow of gas to the NO (nitrogen monoxide) sensor (240).

The first and second flow sensors (160, 260) measure the flow rate (or intensity) of the exhaled gas blown out by the user, the temperature and humidity sensor (250) detects the temperature and humidity of the exhaled gas, and the NO sensor detects nitrogen monoxide (NO) contained in the exhaled gas.

However, the sensors (160, 240, 250, 260) described in the present embodiment are merely exemplified as sensors necessary for the basic operation of the expiratory analysis and spirometry device according to the present embodiment, and are not intended to be limiting, and it should be noted that sensors for detecting various components for extracting and analyzing alveolar gas may be further included.

Below, a method for operating the expiratory analysis and spirometry device according to the present embodiment in spirometry mode is described.

FIG. 3 is an exemplary diagram for explaining how the expiratory analysis and spirometry device of FIG. 2 operates in spirometry mode, and FIG. 4 is an exemplary diagram showing more specifically the switching states of the first to third 3-way valves in spirometry mode of FIG. 3.

In order to measure lung capacity in the above spirometry mode, the flow rate of the exhaled gas blown out to the maximum by the user must be detected, and for this purpose, as shown in FIG. 3, the exhaled gas input through the gas inlet (110) must be delivered to the first flow rate sensor (160).

The above processor (300) controls the first and second 3-way valves (130, 150) so that the exhaled gas input through the gas inlet (110) proceeds in the direction shown in FIG. 3 and is delivered to the first flow sensor (160).

At this time, the third 3-way valve (220) is not used, so it does not matter in which direction it is switched, but in order to maintain the flow of alveolar gas at a constant intensity to the NO sensor (240) in the subsequent alveolar gas extraction and analysis mode, it is preferable to allow the outside air to flow to the second flow sensor (260) through switching (switching ①).

Referring to FIG. 4, the processor (300) causes the exhaled gas passing through the first filter (120) to flow into the sampling loop (140) through switching (switching ①) of the first 3-way valve (130).

In addition, the processor (300) causes the exhaled gas passing through the sampling loop (140) to flow to the first flow sensor (160) through switching (switching ①) of the second 3-way valve (150).

As described above, the flow rate of the exhaled gas blown by the user passes through the first flow rate sensor (160), and the processor (300) calculates multiple lung capacity parameters (e.g., FVC, FEV1, FEV1/FVC, FEF 25% to 75%, PEF, etc.) based on the flow rate measured by the first flow rate sensor (160).

The following describes how the expiratory analysis and spirometry device according to the present embodiment operates in alveolar gas extraction and analysis mode.

FIG. 5 is an exemplary diagram for explaining how the expiratory analysis and spirometry device of FIG. 2 operates in the alveolar gas extraction and analysis mode, and FIG. 6 is an exemplary diagram showing more specifically the switching states of the first to third 3-way valves in the alveolar gas extraction and analysis mode of FIG. 5.

First, we will explain the method of extracting alveolar gas.

For reference, nitric oxide (NO) is known as a biomarker in exhaled gas associated with lung diseases such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and pneumonia.

However, in order for the nitric oxide (NO) to be exhaled through expiration at a sufficient concentration, unlike the spirometry where the user must blow exhalation at maximum force (flow rate), the user must blow exhalation at a constant, appropriate force (flow rate).

In addition, in order to analyze exhaled gas related to lung disease, the alveolar gas emitted at the end of exhalation must be extracted. To do this, it is necessary to monitor whether the user blows exhalation consistently at an appropriate force, and to extract and temporarily store only the alveolar gas emitted at the end of exhalation.

For reference, although not specifically shown in the drawing, monitoring means (e.g., sound monitoring means, display monitoring means) (not shown) for the above monitoring may be further included. For example, the sound monitoring means may output a tone (or volume) differently depending on the strength of the exhalation, and the display monitoring means may output a graph (or number) depending on the strength of the exhalation.

The above processor (300) can induce the user to blow air at a certain intensity through the monitoring means (not shown).

Meanwhile, when the user exhales at a constant rate and the breathing ends, the rate of the first flow sensor (160) drops sharply to 0, and at this time, the processor (300) switches the first to third 3-way valves (130, 150, 220) (i.e., switching from ① to ②) to stop the inflow of exhaled gas and causes the exhaled gas stored in the sampling loop to flow to the second flow sensor (260) through the suction force of the pump.

For reference, at the moment when the user's expiration ends, the alveolar gas exhaled at the end of the expiration is stored within the sampling loop (140).

That is, through the switching change of the second 3-way valve (150) (i.e., from switching ① to switching ②), the alveolar gas discharged at the end of the expiration stored in the sampling loop (140) does not flow to the first flow sensor (160), but instead, the flow path is switched toward the third 3-way valve (220) and flows toward the NO sensor (240).

At this time, the third 3-way valve (220) is in the switching state ① just before the second 3-way valve (150) is switched (i.e., switched from switching ① to switching ②), and is switched to the switching state ② at the same time as the second 3-way valve (150) is switched (i.e., switched from switching ① to switching ②). The reason for this is to maintain the flow of gas at a constant intensity to the NO sensor (240) by sucking in outside air through the pump (270).

That is, when the alveolar gas stored in the sampling loop (140) is suddenly sucked in by the pump (270) in order to be measured by the NO sensor (240), the initial measurement of the NO sensor (240) becomes unstable due to the sudden gas flow, so the purpose is to maintain the gas flow constant before and after the switching is performed in order to eliminate the unstable state.

Below, a method for analyzing the extracted alveolar gas is described.

When the first to third 3-way valves (130, 150, 220) are switched (i.e., switched from switching ① to switching ②), the alveolar gas stored in the sampling loop (140) is sucked by the pump (270) and flows to the Nafion tube (230), the NO sensor (240), the temperature and humidity sensor (250), and the second flow sensor (260).

That is, the flow of respiratory gas proceeds in the direction shown in Fig. 5.

At this time, the processor (300) controls the pump (270) to allow the exhaled gas to flow at a constant rate, thereby stably measuring the NO concentration, temperature and humidity, and flow rate.

For example, if the above NO concentration exceeds the standard value, it can be considered that there is an abnormality in lung diseases such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, and pneumonia.

Meanwhile, since the measurement value of the NO sensor (240) may vary depending on changes in temperature and humidity, the processor (300) may monitor temperature and humidity to compensate for changes in the measurement value due to the temperature and humidity, and may also monitor the flow rate to adjust the strength of the pump (270) to confirm whether the exhaled gas flowing to the NO sensor (240) is maintained at a constant strength.

For reference, the above Nafion tube (230) is formed of a material that absorbs moisture, thereby reducing the humidity of the alveolar gas flowing to the NO sensor (240).

As described above, the present embodiment can noninvasively screen for lung disease by extracting and analyzing alveolar gas components related to lung disease in exhaled gas, and simultaneously measure lung capacity, thereby enabling both expiratory analysis and spirometry to be performed with a single device, thereby improving convenience and reducing costs.

The present invention has been described above with reference to the embodiments illustrated in the drawings, but this is merely exemplary, and those skilled in the art will understand that various modifications and equivalent other embodiments are possible from this. Accordingly, the technical protection scope of the present invention should be determined by the following patent claims. In addition, the implementation described in this specification can be implemented as, for example, a method or process, a device, a software program, a data stream, or a signal. Even if discussed only in the context of a single form of implementation (e.g., discussed only as a method), the implementation of the discussed feature can also be implemented in other forms (e.g., a device or a program). The device can be implemented as appropriate hardware, software, and firmware. The method can be implemented in a device such as a processor, which generally refers to a processing device including, for example, a computer, a microprocessor, an integrated circuit, or a programmable logic device. The processor also includes a communication device such as a computer, a cell phone, a personal digital assistant ("PDA"), and other devices that facilitate the communication of information between end-users.

110 : Gas inlet 120 : 1st filter
130: 1st 3way valve 140: Sampling loop
150: 2nd 3way valve 160: 1st flow sensor
210: 2nd filter 220: 3rd 3way valve
230: Nafion tube 240: NO (nitrogen monoxide) sensor
250: Temperature and humidity sensor 260: Second flow sensor
270 : Pump 300 : Processor

Claims (1)

First, second, and third 3-way valves forming the flow path of the respiratory gas;
A sampling loop connected between the first and second 3-way valves;
A flow sensor for measuring the flow rate of exhaled gas discharged from the second 3-way valve;
A sensor that analyzes the exhaled gas discharged from the third 3-way valve;
A processor that controls the flow of the exhaled gas by switching the first to third 3-way valves according to the operation mode; and
An expiratory analysis and spirometry device for screening for lung diseases, comprising: a pump for drawing in outside air and causing exhaled gas stored in the sampling loop to flow toward the sensor side, in the extraction and analysis mode of alveolar gas.

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