CN117814777A - Expired nitric oxide measuring device and method - Google Patents
Expired nitric oxide measuring device and method Download PDFInfo
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- CN117814777A CN117814777A CN202311838199.0A CN202311838199A CN117814777A CN 117814777 A CN117814777 A CN 117814777A CN 202311838199 A CN202311838199 A CN 202311838199A CN 117814777 A CN117814777 A CN 117814777A
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- MWUXSHHQAYIFBG-UHFFFAOYSA-N Nitric oxide Chemical compound O=[N] MWUXSHHQAYIFBG-UHFFFAOYSA-N 0.000 title claims abstract description 284
- 238000000034 method Methods 0.000 title claims abstract description 45
- 238000012360 testing method Methods 0.000 claims abstract description 145
- 238000004868 gas analysis Methods 0.000 claims abstract description 78
- 238000005259 measurement Methods 0.000 claims abstract description 31
- 238000004458 analytical method Methods 0.000 claims abstract description 24
- 239000007789 gas Substances 0.000 claims description 228
- 238000004364 calculation method Methods 0.000 claims description 24
- 230000008569 process Effects 0.000 claims description 17
- 230000037396 body weight Effects 0.000 claims description 5
- 238000000691 measurement method Methods 0.000 claims description 3
- 238000007599 discharging Methods 0.000 claims description 2
- 238000005086 pumping Methods 0.000 claims description 2
- 239000000284 extract Substances 0.000 abstract 1
- 238000012795 verification Methods 0.000 description 17
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 16
- 238000002474 experimental method Methods 0.000 description 13
- 238000005070 sampling Methods 0.000 description 13
- 229910002092 carbon dioxide Inorganic materials 0.000 description 8
- 239000001569 carbon dioxide Substances 0.000 description 8
- 238000001514 detection method Methods 0.000 description 8
- 230000007613 environmental effect Effects 0.000 description 7
- 238000013313 FeNO test Methods 0.000 description 6
- 238000013461 design Methods 0.000 description 6
- 238000010586 diagram Methods 0.000 description 6
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 5
- 210000004072 lung Anatomy 0.000 description 5
- 229910052760 oxygen Inorganic materials 0.000 description 5
- 239000001301 oxygen Substances 0.000 description 5
- 230000029058 respiratory gaseous exchange Effects 0.000 description 5
- 238000013480 data collection Methods 0.000 description 4
- 239000006185 dispersion Substances 0.000 description 4
- 230000002685 pulmonary effect Effects 0.000 description 4
- 210000002345 respiratory system Anatomy 0.000 description 4
- 210000002469 basement membrane Anatomy 0.000 description 3
- 230000008859 change Effects 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000011010 flushing procedure Methods 0.000 description 3
- 230000010354 integration Effects 0.000 description 3
- 230000036961 partial effect Effects 0.000 description 3
- 230000002829 reductive effect Effects 0.000 description 3
- 230000000241 respiratory effect Effects 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- NAWXUBYGYWOOIX-SFHVURJKSA-N (2s)-2-[[4-[2-(2,4-diaminoquinazolin-6-yl)ethyl]benzoyl]amino]-4-methylidenepentanedioic acid Chemical compound C1=CC2=NC(N)=NC(N)=C2C=C1CCC1=CC=C(C(=O)N[C@@H](CC(=C)C(O)=O)C(O)=O)C=C1 NAWXUBYGYWOOIX-SFHVURJKSA-N 0.000 description 2
- 206010006322 Breath holding Diseases 0.000 description 2
- 238000012351 Integrated analysis Methods 0.000 description 2
- 208000037883 airway inflammation Diseases 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000001601 blood-air barrier Anatomy 0.000 description 2
- 238000004422 calculation algorithm Methods 0.000 description 2
- 238000012790 confirmation Methods 0.000 description 2
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- 238000005516 engineering process Methods 0.000 description 2
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- 238000012544 monitoring process Methods 0.000 description 2
- 230000000717 retained effect Effects 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 238000012418 validation experiment Methods 0.000 description 2
- UGFAIRIUMAVXCW-UHFFFAOYSA-N Carbon monoxide Chemical compound [O+]#[C-] UGFAIRIUMAVXCW-UHFFFAOYSA-N 0.000 description 1
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 1
- 206010011409 Cross infection Diseases 0.000 description 1
- 241000590002 Helicobacter pylori Species 0.000 description 1
- 102000001554 Hemoglobins Human genes 0.000 description 1
- 108010054147 Hemoglobins Proteins 0.000 description 1
- 206010061218 Inflammation Diseases 0.000 description 1
- 206010029803 Nosocomial infection Diseases 0.000 description 1
- 210000005058 airway cell Anatomy 0.000 description 1
- 210000002821 alveolar epithelial cell Anatomy 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 238000011861 anti-inflammatory therapy Methods 0.000 description 1
- 208000006673 asthma Diseases 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 229910002091 carbon monoxide Inorganic materials 0.000 description 1
- 210000002808 connective tissue Anatomy 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000009795 derivation Methods 0.000 description 1
- 210000003989 endothelium vascular Anatomy 0.000 description 1
- 210000003743 erythrocyte Anatomy 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 229940037467 helicobacter pylori Drugs 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
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- 208000023504 respiratory system disease Diseases 0.000 description 1
- 238000006467 substitution reaction Methods 0.000 description 1
- 239000012085 test solution Substances 0.000 description 1
- 238000012956 testing procedure Methods 0.000 description 1
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
- G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
- A61B5/087—Measuring breath flow
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D46/00—Filters or filtering processes specially modified for separating dispersed particles from gases or vapours
- B01D46/24—Particle separators, e.g. dust precipitators, using rigid hollow filter bodies
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F17—STORING OR DISTRIBUTING GASES OR LIQUIDS
- F17D—PIPE-LINE SYSTEMS; PIPE-LINES
- F17D1/00—Pipe-line systems
- F17D1/02—Pipe-line systems for gases or vapours
- F17D1/04—Pipe-line systems for gases or vapours for distribution of gas
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F17—STORING OR DISTRIBUTING GASES OR LIQUIDS
- F17D—PIPE-LINE SYSTEMS; PIPE-LINES
- F17D3/00—Arrangements for supervising or controlling working operations
- F17D3/01—Arrangements for supervising or controlling working operations for controlling, signalling, or supervising the conveyance of a product
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- F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
- F17—STORING OR DISTRIBUTING GASES OR LIQUIDS
- F17D—PIPE-LINE SYSTEMS; PIPE-LINES
- F17D5/00—Protection or supervision of installations
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Abstract
The invention discloses an expired nitric oxide measuring device and method, and relates to the expired nitric oxide measuring field, wherein a three-way valve in the device extracts air into a gas analysis device to realize zero point test; the expiration channel device is filled with sample gas after zero point test; the control unit controls the emptying valve to be opened, and the introduced sample gas is discharged according to the emptying time; the three-way valve is used for introducing the sample gas discharged by the discharge valve into the gas analysis device so as to analyze the gas concentration of the introduced sample gas; the control unit determines the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result; the evacuation time is determined according to the sex, age, weight, volume of inhaled test gas, concentration of nitric oxide in exhaled test gas, and flow rate of exhaled test gas of the subject. The invention can reduce the measurement cost and improve the measurement efficiency.
Description
Technical Field
The invention relates to the field of expiration measurement, in particular to an expired Nitric Oxide (NO) measurement device and method.
Background
The production of nitric oxide by airway cells, as measured by exhalation, is an internationally recognized marker of airway inflammation, and can be used to diagnose airway inflammation, guiding the assessment of anti-inflammatory therapy. The technology of detecting the nitric oxide in expiration has been used for detecting inflammation and evaluating anti-inflammatory treatment of respiratory diseases such as asthma, chronic obstructive pulmonary disease and the like at present, but has two practical problems in popularization and application:
to ensure that exhalation is measured by the environment NO that is produced by the respiratory tract, but not inhaled and retained in the dead space of the respiratory tract, all techniques currently on the market use the methods recommended by international standards: clean gas containing NO or NO <5ppb is first inhaled through the NO filter, dead space gas that may contain ambient NO in the airway prior to replacement is then exhaled to measure NO produced by the airway. Such inhalation-exhalation actions of NO exhalation detection are somewhat cumbersome compared to the expiration test of helicobacter pylori requiring NO inhalation, but only simple expiration, and more serious, such inhalation may cause the subject to worry about cross infection and reject the test. In addition, the additional use of NO filters and additional components such as gas valve pumps for separate sampling and analysis increases the cost of detection, further hampering the popularization of exhalation detection techniques.
Secondly, in order to ensure that the expiration measurement is the gas generated by the respiratory tract and having stable concentration or in the platform period, all the current detection technologies of the sensors on the market adopt the method recommended by the international standard: analysis was sampled after children and adults exhaled for more than 6 and 10 seconds, respectively, at a constant 50ml/s expiratory flow rate (allowing 10% fluctuation). Since the corresponding time of NO sensors is typically over 10 seconds, the method of sampling 6 or 10 seconds before sending to the sensor for 20-30 seconds is typically used, plus the zero point test required for each test, typically requiring a test time of over 50 seconds. Such NO exhalation detection is not only not suitable for patients who cannot exhale at a constant rate for 6 or 10 seconds, but also appears to be somewhat tugged.
In summary, the existing exhaled nitric oxide measurement method has high cost and low measurement efficiency.
Disclosure of Invention
Based on the above, the embodiment of the invention provides an expired nitric oxide measuring device and method, which are used for reducing the measuring cost and improving the measuring efficiency.
In order to achieve the above object, the embodiment of the present invention provides the following solutions:
an exhaled nitric oxide measurement device, comprising: the device comprises an expiration channel device, a three-way valve, an evacuation valve, a gas analysis device and a control unit;
the output end of the expiration channel device is respectively connected with the first ends of the evacuation valve and the three-way valve; the second end of the three-way valve is connected with the gas analysis device; the gas analysis device is connected with the control unit;
the three-way valve is used for pumping air into the gas analysis device;
the gas analysis device is used for analyzing the gas concentration of the air to realize zero point test;
the expiration channel device is used for introducing sample gas after zero point test; the sample gas is a test gas exhaled by the subject;
the control unit is also used for controlling the three-way valve to be closed and the evacuation valve to be opened after the sample gas is introduced into the expiration channel device, so that the evacuation valve starts to discharge the introduced sample gas until the evacuation time is reached, and controlling the evacuation valve to be closed and the three-way valve to be opened;
wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined according to the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject;
the three-way valve is also used for introducing the sample gas discharged by the emptying valve into the gas analysis device;
the gas analysis device is also used for carrying out gas concentration analysis on the introduced sample gas to obtain a sample analysis result;
the control unit is also used for determining the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result.
Optionally, the formula for calculating the emptying time is:
wherein T is 0 Indicating the evacuation time; v (V) D Representing the volume of a physiological dead space; q represents the flow of test gas exhaled by the subject;
if the sex of the subject is male, the calculation formula of the volume of the physiological dead space is as follows:
wherein V is I Representing the volume of test gas inhaled by the subject; FA (FA) NO (t 1 ) Indicating the concentration of nitric oxide in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide in the test gas exhaled by the subject; age represents the Age of the subject; height represents the body weight of the subject; t is t 1 Indicating the time at which the subject inhaled the test gas; t is t 2 Indicating the time at which the subject exhales the test gas; t is t 2 -t 1 Representing an expiration measurement period;
if the sex of the subject is female, the calculation formula of the volume of the physiological dead space is as follows:
optionally, the exhaled nitric oxide measurement device further comprises: a diverter valve; the shunt valve is connected with the expiration channel device; the control unit is also used for controlling the diverter valve to be opened when the flow rate of the sample gas is larger than a set flow rate value, and the diverter valve and the emptying valve are used for discharging the introduced sample gas together until the emptying time is reached.
Optionally, the gas analysis device is at least one; different gas analysis devices analyze the concentration of different gas components in the introduced sample gas; at least one gas analysis device analyzes the concentration of nitric oxide in the introduced sample gas.
Optionally, the exhaled nitric oxide measurement device further comprises: a filter; the third end of the three-way valve is connected with the filter; the filter is used for leading the filtered air into the gas analysis device through the three-way valve.
Optionally, the exhaled nitric oxide measurement device further comprises: a pump; the second end of the three-way valve is connected with the gas analysis device through the pump.
Optionally, the exhaled nitric oxide measurement device further comprises: a flow sensor; the flow sensor is connected with the expiration channel device; the flow sensor is used for measuring the flow of test gas exhaled by the subject.
The invention also provides an expired nitric oxide measuring method which is used for the expired nitric oxide measuring device; the method comprises the following steps: a zero point test process and a sample gas test process;
the zero point test process comprises the following steps:
opening a three-way valve to extract air into the gas analysis device, and analyzing the gas concentration of the air by the gas analysis device to realize zero point test;
after the zero point test, starting a sample gas test process;
the sample gas testing process includes:
introducing a sample gas through an exhalation passage assembly; the sample gas is a test gas exhaled by the subject;
the control unit is used for closing the three-way valve and opening the evacuation valve after the sample gas is introduced into the expiration channel device, so that the evacuation valve starts to discharge the introduced sample gas until the evacuation time is reached, and closing the evacuation valve and opening the three-way valve; the three-way valve is used for introducing the sample gas discharged by the emptying valve into the gas analysis device;
wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined according to the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject;
the gas analysis device analyzes the gas concentration of the introduced sample gas to obtain a sample analysis result;
the control unit determines the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result.
According to the specific embodiment provided by the invention, the invention discloses the following technical effects:
the control unit of the embodiment of the invention controls the emptying valve to discharge the introduced sample gas according to the emptying time, so that the gas in the physiological dead space of the subject is completely discharged, the emptying time is determined according to the sex, age and weight of the subject, the volume of the test gas inhaled by the subject, the concentration of nitric oxide in the test gas exhaled by the subject and the flow of the test gas exhaled by the subject, the dead space gas which possibly contains environmental NO and is retained in the respiratory tract before the NO filter is additionally replaced is not needed before detection, the test cost is reduced, the constant-speed continuous exhalation of the subject for 6 or 10 seconds is also not needed for sampling, and the measurement efficiency is improved.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions of the prior art, the drawings that are needed in the embodiments will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present invention, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
Fig. 1 is a first block diagram of an apparatus for measuring nitric oxide in expired air according to an embodiment of the present invention;
fig. 2 is a second block diagram of an apparatus for measuring nitric oxide in expired air according to the embodiment of the present invention;
fig. 3 is a block diagram of the overall design of an apparatus for measuring nitric oxide in expired air according to an embodiment of the present invention;
fig. 4 is an exploded view of a detailed structure of example 1 provided by an embodiment of the present invention;
fig. 5 is a difference chart corresponding to difference data of example 1 according to an embodiment of the present invention;
fig. 6 is a line graph corresponding to correlation coefficient data of example 1 provided in an embodiment of the present invention;
FIG. 7 is an exploded view of the detailed construction of example 2 provided by an embodiment of the present invention;
FIG. 8 is a graph of differences corresponding to the difference data of the first verification experiment of example 2 according to an embodiment of the present invention;
fig. 9 is a line graph corresponding to correlation coefficient data of a first verification experiment of example 2 provided in an embodiment of the present invention;
fig. 10 is a difference chart corresponding to difference data of a second verification experiment of example 2 according to an embodiment of the present invention;
FIG. 11 is a line graph corresponding to correlation coefficient data of a second verification experiment of example 2 provided in an embodiment of the present invention;
fig. 12 is a difference chart corresponding to difference data of a third verification experiment of example 2 according to an embodiment of the present invention;
fig. 13 is a line graph corresponding to correlation coefficient data of a third verification experiment of example 2 provided in an embodiment of the present invention.
Symbol description:
the device comprises an expiration channel device-100, a flow sensor-200, an evacuation valve-300, a three-way valve-400, a pump-500, a gas analysis device-600, a filter-700, a control unit-800, a flow dividing valve-300 ', a gas analysis device-600', an instrument upper cover-1, an instrument lower cover-2 and a mounting bracket-3.
Detailed Description
The technical solutions in the embodiments of the present invention will be described below with reference to the accompanying drawings in the embodiments of the present invention.
In order that the above-recited objects, features and advantages of the present invention will become more readily apparent, a more particular description of the invention will be rendered by reference to the appended drawings and appended detailed description.
Referring to fig. 1, the exhaled nitric oxide measuring device of the present embodiment includes: an exhalation passageway device 100, a three-way valve 400, an evacuation valve 300, a gas analysis device 600, and a control unit 800.
The output end of the exhalation channel assembly 100 is connected to the first ends of the evacuation valve 300 and the three-way valve 400, respectively; a second end of the three-way valve 400 is connected to the gas analysis device 600; the gas analysis device 600 is connected to the control unit 800.
The three-way valve 400 is used to draw air into the gas analysis device 600.
The gas analysis device 600 is configured to perform gas concentration analysis on air to implement a zero point test, so as to obtain a zero point test result; the zero point test result comprises: zero point value; the zero point value is the concentration of nitric oxide in air, and is used as a test reference.
The control unit 800 is configured to obtain a zero value according to a result of the zero test.
The exhalation channel apparatus 100 is used for introducing sample gas after zero point test; the sample gas is a test gas exhaled by the subject.
The control unit 800 is further configured to control the three-way valve 400 to be closed and the evacuation valve 300 to be opened after the sample gas is introduced into the exhalation channel device 100, so that the evacuation valve 300 starts to discharge the introduced sample gas until the evacuation time is reached, and control the evacuation valve 300 to be closed and the three-way valve 400 to be opened.
Wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined based on the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject.
The formula for calculating the emptying time is as follows:
wherein T is 0 Indicating the evacuation time; v (V) D Representing the volume of a physiological dead space; q represents the flow of test gas exhaled by the subject.
If the sex of the subject is male, the calculation formula of the volume of the physiological dead space is as follows:
wherein V is I Representing the volume of test gas inhaled by the subject; FA (FA) NO (t 1 ) Indicating the concentration of nitric oxide in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide in the test gas exhaled by the subject; age represents the Age of the subject; height represents the body weight of the subject; t is t 1 Indicating the time at which the subject inhaled the test gas; t is t 2 Indicating the time at which the subject exhales the test gas; t is t 2 -t 1 Indicating an expiration measurement period.
If the sex of the subject is female, the calculation formula of the volume of the physiological dead space is as follows:
the three-way valve 400 is also used to introduce the sample gas discharged from the evacuation valve 300 into the gas analysis device 600.
The gas analysis device 600 is further configured to perform gas concentration analysis on the introduced sample gas, so as to obtain a sample analysis result. The sample analysis results include: a sample gas value; the sample gas value is a concentration analysis value of nitric oxide in the sample gas.
The control unit 800 is further configured to determine the concentration of nitric oxide in the sample gas based on the result of the zero point test (i.e. the zero point value) and the sample analysis result (i.e. the sample gas value). Specifically, the concentration of nitric oxide in the sample gas is calculated according to the formula c= (I1-I0)/S; c represents the concentration of nitric oxide in the sample gas; i1 represents a sample gas value; i0 represents a zero point value; s represents the sensitivity of the gas analysis device 600.
In one example, still referring to fig. 1, the exhaled nitric oxide measurement device further comprises: filter 700, pump 500, and flow sensor 200.
A third end of the three-way valve 400 is connected to the filter 700; the filter 700 is used to introduce the filtered air into the gas analysis device 600 through the three-way valve 400. The second end of the three-way valve 400 is connected to the gas analysis device 600 through the pump 500. The flow sensor 200 is connected to the exhalation passage assembly 100; the flow sensor 200 is used to measure the flow of test gas exhaled by the subject.
In one example, referring to fig. 2, the exhaled nitric oxide measurement device further includes: a diverter valve 300'; the shunt valve 300' is connected to the exhalation port assembly 100; the control unit 800 is further configured to control the diverter valve 300 'to open when the flow rate of the sample gas is greater than the set flow rate value, and the diverter valve 300' and the evacuation valve 300 together discharge the introduced sample gas until the evacuation time is reached. For example, when the flow rate of the sample gas is 50ml/s, the diverter valve is closed, and the emptying valve 300 is independently adopted to discharge the introduced sample gas until the emptying time is reached; when the flow rate of the sample gas is 200ml/s, the evacuation valve 300 and the shunt valve 300' are simultaneously opened to discharge the introduced sample gas together until the evacuation time is reached.
In one example, referring still to fig. 2, the gas analysis device 600 is at least one; the different gas analysis devices 600 analyze the concentration of different gas components in the introduced sample gas; at least one gas analysis device 600 analyzes the concentration of nitric oxide in the introduced sample gas.
According to the expired air nitric oxide measuring device of the embodiment, the control unit 800 calculates the evacuation time through an intelligent physiological dead space algorithm, so that the intelligent discharge of the physiological dead space is realized, the device is integrated, the internal volume of the instrument is reduced, and the cost and the size of the instrument are reduced due to high integration and miniaturization.
The above-mentioned exhaled nitric oxide measuring device will be described in further detail below.
In the embodiment, the regression equation established by the physiological dead space determined by NO and parameters such as height, age, weight and the like is used for realizing intelligent setting of the emptying time and the sampling time; increasing the detection of the environmental NO, and adding the environmental NO to an association equation, so as to avoid the influence of the environmental NO on the test; the intelligent control of sampling time is realized, different people realize different expiration sampling time, realize accurate sampling. The integrated analysis device reduces the internal volume of the instrument; the high integration reduces the cost of the instrument.
Firstly, a specific process of calculating the emptying time by adopting a built-in intelligent physiological dead space algorithm by a control unit is introduced.
The determination of the physiological dead space by NO requires consideration of the following factors: lung diffusion capacity of NO gas, height, weight, age, ambient Nitric Oxide (NO) content of the subject, and the like.
Pulmonary dispersion function refers to the ability of some alveolar gas to diffuse from the alveoli to the capillaries through the alveolar-capillary membrane (consisting of the alveolar epithelium and its basement membrane, the alveolar capillary endothelium and its basement membrane, and connective tissue between 2 basement membranes) to the blood and bind to hemoglobin (Hb) in erythrocytes. The gas exchanged in the alveolar-capillary membrane is mainly oxygen (O 2 ) And carbon dioxide (CO) 2 ). Because the dispersion amount of oxygen is directly calculated, the average partial pressure of the oxygen in the pulmonary capillary blood is required to be measured, and the method is complex; and carbon monoxide (CO) and hemoglobinIs higher than oxygen (O) 2 ) By a factor of 210, the partial pressure of oxygen in the physiological range is not a major contributor; except for a large number of smokers, the content of CO in the plasma of normal people is almost zero, so that the intake of CO in the examination can be calculated conveniently; moreover, CO is rarely dissolved in plasma during transport, so CO becomes an ideal gas for measuring pulmonary dispersion function. The pulmonary diffusion capacity of NO gas is four times that of CO.
In order to overcome the defects that the existing airway dead space calculation is greatly interfered by the breathing of a user and the measurement of the airway dead space is inaccurate, the method for calculating the airway dead space in the exhalation nitric oxide measurement process of the embodiment comprises the following steps:
the lung nitric oxide dispersion refers to the volume of nitric oxide passing through the whole respiratory membrane in unit time under unit partial pressure, and reflects the blocking degree of the respiratory membrane on nitric oxide gas exchange to a certain extent. DL (DL) NO The test solution includes a single respiration method, a repeated respiration method and a constant state method. The invention only adopts a single respiration method: connecting a Shang Wo nitric oxide analyzer, deeply inhaling NO mixed gas with concentration of a to the residual gas position, rapidly inhaling NO mixed gas with concentration of a to the total lung position, closing gas for 1s-2s, exhaling to the residual gas position, respectively recording the flow and gas concentration change of the whole respiratory process by the flowmeter and the nitric oxide analyzer, and calculating DL according to the alveolar gas volume and the alveolar NO concentration change in a specific time period NO Comprises physiological dead space and alveolar gas. The measurement is repeated once every 5-10min, and the error is within 5%. The calculation formula is as follows:
in DL NO Is the diffuse amount of nitric oxide in the lung; v (V) A Representing alveolar volume; v (V) I A volume of test gas (mixed gas) inhaled for the subject; v (V) D Is the volume of the physiological dead space; t is t 2 -t 1 Representative expiration testA metering time period; FA (FA) NO (t 1) represents the concentration of nitric oxide (ppd) in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide (ppd) in the test gas exhaled by the subject;representing the NO index concentration change in the expiration measuring section; k is a constant, and the available value is 1000 multiplied by 60/(PB-47); PB is the atmospheric pressure (mmHg) of the test environment.
The physiologic dead space is equal to the sum of alveolar dead space and anatomical dead space, and because anatomical dead space is fixed, the ratio of physiologic dead space to tidal volume substantially reflects the size of alveolar dead space.
V A ＝V C +V D (3)
Wherein V is C Is the vital capacity. Vital capacity V C The calculation formula of (2) is as follows:
if the subject is male, the calculation formula is:
V C ＝[27.63-0.112*Age]*Height (4)
if the subject is male, the calculation formula is:
V C ＝[27.78-0.101*Age]*Height (5)
to sum up, the formula derivation is performed:
from the simultaneous equations of equations (1) and (3), the following calculation equation can be obtained:
substituting the formula (6) into the formula (2) to obtain the following calculation formula:
substituting formula (4) into (7) to obtain male V as follows D The calculation formula is as follows:
substituting formula (5) into (7) to obtain female V as follows D The calculation formula is as follows:
substituting formula (7) into (1) to obtain DL NO The formula is as follows:
will lead male to vital capacity V C Substituting formula (4) into formula (10) to obtain male DL NO The formula is as follows:
will female vital capacity V C Substituting formula (5) into formula (10) to obtain female DL NO The formula is as follows:
the volume of the test gas inhaled by the subject is V I The flow sensor is responsible for monitoring the breathing gas volume in the test flow of the tester in real time, including the volume of the test gas inhaled by the tester.
Volume of physiological dead space V D : in the expiration stage after breath holding in a one-port gas method test flow, a bypass flow acquisition method is adopted, an electrochemical nitric oxide sensor provides a real-time variation signal curve of the concentration of an expiration gas component along with the expiration volume, and the characteristic that nitric oxide is not diluted by lung residual gas in the dead space of equipment and the dead space of a human body is utilized to obtain a dead space flushing point, namely the nitric oxide concentration of gas in the expiration initial stage is relatively higher, so that the nitric oxide concentration information is accurately judgedAnd (5) obtaining a dead space flushing point and a dead space volume by changing the inflection point.
Exhaled gas component concentration (FA NO (t)): in the expiration stage after breath holding in a one-port gas method test flow, a bypass flow acquisition method is adopted, and an electrochemical nitric oxide sensor provides a real-time variation signal curve of the concentration of the expired gas component along with the expired volume, so as to obtain a reasonable evaluation of the concentration of the expired gas component (FA NO (t)) should be sampled after the expired gas component concentration has stabilized, i.e. 500mL of expired gas is selected as the expired gas component concentration sampling sample after the dead space flushing point, while providing the user with the option of manually shifting the sample sampling point backwards to ensure that the dead space is fully flushed.
According to the above formula, carrying out test confirmation on 30 subjects of normal people, carrying out expiration test confirmation on the subjects inhaling clean air 1L (the NO concentration is less than 5 ppb), wherein the expiration test time is 10s, and measuring the exhaled NO concentration to be 10ppb; the subject was confirmed by an expiration test at an inhaled NO concentration of 100ppb in 1L of the gas mixture, and the exhaled NO concentration was measured to be 20ppb for 10 seconds. The following parameters can be obtained. V (V) I 1L.
t 2 -t 1 Substitution value is 10s, FA NO (t 1 ) The value is 100ppb; FA (FA) NO (t 2 ) The value is 20-10=10 ppb.
Male V D The calculation formula is as follows:
female V D The calculation formula is as follows:
the drain time can be calculated as:
male T 0 ：
Female T 0 ：
T 0 Indicating the evacuation time; q represents the flow of test gas exhaled by the subject.
Through the design, the height, the age and the sex of the testee are input into the user interface, so that the physiological dead space can be intelligently emptied, intelligent control is realized, and the quality control is friendly under the condition that the human body is comfortable.
After the above-mentioned evacuation time is obtained, an expired nitric oxide measuring device based on the above-mentioned evacuation time will be described below.
Referring to fig. 3, the overall design concept of the exhaled nitric oxide measuring device is: comprises an exhalation passage device 100, a flow sensor 200, a three-way valve 400, a pump 500, a gas analysis device 600, and a control unit 800. The flow sensor 200 is mounted on the exhalation passageway device 100, performs flow monitoring, and provides flow data to the control unit 800. The three-way valve 400 is installed at the rear end of the exhalation passageway device 100, one end achieves the function of exhaling and evacuating, and the other end is connected to the pump 500, and after evacuating, the valve is switched to connect one end of the pump 500. The pump 500 is connected to the rear end of the three-way valve 400, and pumps air, and the rear end of the pump 500 is connected to the gas analysis device 600, so that the gas is transported to the gas analysis device and analyzed. The control unit 800 controls the three-way valve 400 and the pump 500, and the control unit 800 performs functions such as data collection and analysis of the flow sensor 200 and the gas analysis device 600. The exhalation passageway assembly 100 is of streamlined design with a conduit design taper angle of 10 ° to 15 °, preferably 15 °.
The whole test thought of the expired nitric oxide measuring device is as follows:
(1) The zero point test is performed, the three-way valve 400 is connected to one end of the pump 500, and air in the exhalation port device 100 is extracted and enters the gas analysis device 600 to perform the zero point test. The control unit 800 performs data collection and calculation to obtain a zero point value I0.
(2) Carrying out a sample gas test, wherein the test subject adopts a certain flow rate such as: the Q is 50mL/s, the Q is 2mL/s, the gas is breathed into the expiration channel device 100, the gas is discharged through the three-way valve 400, and after the gas is discharged, the three-way valve 400 is switched to the pump 500 to pump the gas in the expiration channel device 100 into the gas analysis device 600; the evacuation time is calculated by the control unit 800 according to the sex, height and age data input by the subject to obtain a sample gas value I1, and the three-way valve 400 is intelligently controlled to realize intelligent evacuation.
(3) Through the above zero point test and the sample gas test, it is possible to calculate the gas concentration c=i1-I0/S, where S is the sensitivity S of the gas analysis device is a fixed value.
By the integrated design, the effect of miniaturization can be realized.
Two specific examples of the testing procedure, detailed exploded view structure and effectiveness of the nitric oxide measuring device are further described below in connection with fig. 1 and 2.
Example 1:
still referring to fig. 1, the exhaled nitric oxide measuring device is composed of an exhaled breath channel device 100, a flow sensor 200, an evacuation valve 300, a three-way valve 400, a pump 500, a gas analyzing device 600, a filter 700, and a control unit 800. The test process is as follows:
(1) The zero point test is performed, the three-way valve 400 is connected to one end of the filter 700 and the pump 500, and air is pumped into the gas analysis device 600 to perform the zero point test. The control unit 800 performs data collection and calculation.
(2) Carrying out a sample gas test, wherein a subject exhales gas into the expiration channel device 100 at a flow rate of 50mL/s by adopting a Q, the gas is exhausted through the exhaust valve 300, after the exhaustion is finished, the exhaust valve 300 is closed, and when the sample gas is tested, the pump 500 pumps the sample gas into the expiration channel device 100 through the three-way valve 400 to carry out gas concentration analysis; the evacuation time is calculated by the control unit 800 according to the sex, height and age data input by the subject, and the evacuation valve 300 is intelligently controlled to realize intelligent evacuation.
As shown in fig. 4, an exploded view of the detailed structure of example 1, the entire apparatus includes an instrument upper cover 1, an exhalation passage apparatus 100, a flow sensor 200, an evacuation valve 300, a three-way valve 400, a pump 500, a mounting bracket 3, a gas analysis apparatus 600, a filter 700, a control unit 800, and an instrument lower cover 2. Wherein, the interface at the rear end of the expiration channel device 100 is connected with an evacuation valve 300 and a three-way valve 400; the normally open end of the three-way valve 400 is connected with the pump 500, the other end of the three-way valve is connected with the filter 700, and the rear end of the pump 500 is connected with the gas analysis device 600; wherein the exhalation passageway device 100, the valve 300, the three-way valve 400 and the pump 500 are all mounted on the mounting bracket 3. The flow sensor 200 and the gas analysis device 600 are installed in the instrument lower cover 2; the control unit 800 is mounted on the instrument cover 1.
The device of example 1 (HA 1101-FeNO) was compared to the existing breath analyzer CA 2122-FeNO. Carrying out comparison verification, carrying out total 55 times of test comparison, wherein the average difference value between HA1101-FeNO and a breath analyzer Sunvou-CA2122 is-2.1 ppb (-13.1-9.0 ppb), the correlation coefficient is 0.9412, the difference value data is shown in table 1, and the corresponding difference value graph is shown in fig. 5; the correlation coefficient data is shown in table 2, and the corresponding line graph is shown in fig. 6.
Table 1 difference data table of example 1
Table 2 correlation coefficient data table of example 1
| Variable Y | CA2122FeNO |
| Variable X | HA1101-FeNO |
| Sample size | 55 |
| Correlation coefficient r | 0.9412 |
| Level of significance | P<0.0001 |
| 95% confidence interval (r) | 0.9009-0.9655 |
Example 2:
the FeNO50 test can be performed in example 1, and the present example performs the function of expanding the FeNO200, and realizes a plurality of gas test functions by adding a gas analysis device. Still referring to fig. 2, the exhaled nitric oxide measuring device is composed of an exhaled breath channel device 100, a flow sensor 200, an evacuation valve 300, a shunt valve 300', a three-way valve 400, a pump 500, a gas analyzing device 600, a gas analyzing device two 600', a filter 700 and a control unit 800. The test process is as follows:
(1) The zero point test is performed, the three-way valve 400 is connected to one end of the filter 700 and the pump 500, and air is pumped into the gas analysis device 600 to perform the zero point test. The control unit 800 performs data collection and calculation.
(2) Carrying out a sample gas test, wherein a subject exhales gas into the expiration channel device 100 by adopting a flow rate of 50mL/s and discharges the gas through the evacuation valve 300, at the moment, the shunt valve 300 'is in a closed state, after the evacuation is finished, the evacuation valve 300 is closed, and when the sample gas is tested, the pump 500 pumps the sample gas into the expiration channel device 100 through the three-way valve 400 to pump the sample gas into the gas analysis device 600 and the gas analysis device two 600' for a plurality of gas concentration analyses; the evacuation time is calculated by the control unit 800 according to the sex, height and age data input by the subject, and the evacuation valve 300 is intelligently controlled to realize intelligent evacuation.
(3) Carrying out a sample gas test, wherein a subject exhales gas into the expiration channel device 100 by adopting a flow rate of which the Q is 200mL/s, at the moment, the flow dividing valve 300' and the evacuation valve 300 are in an open state, double evacuation is carried out, after the evacuation is finished, the evacuation valve 300 and the flow dividing valve 300' are closed, and when the sample gas test is carried out, the pump 500 pumps the sample gas in the expiration channel device 100 into the gas analysis device 600 and the gas analysis device two 600' through the three-way valve 400 to carry out a plurality of gas concentration analyses; the evacuation time is calculated by the control unit 800 according to the sex, height and age data input by the subject, and the evacuation valve 300 is intelligently controlled to realize intelligent evacuation.
As shown in fig. 7, an exploded view of the detailed structure of example 2, the whole device includes an instrument upper cover 1, an exhalation channel device 100, a flow sensor 200, an evacuation valve 300, a shunt valve 300', a three-way valve 400, a pump 500, a mounting bracket 3, a gas analysis device 600, a gas analysis device two 600', a filter 700, a control unit 800, and an instrument lower cover 2, wherein the shunt valve 300' is installed at the front end of the exhalation channel device 100, and the rear end of the exhalation channel device 100 is connected to the valve 300 and the three-way valve 400; the normally open end of the three-way valve 400 is connected with the pump 500, the other end of the three-way valve is connected with the filter 700, the rear end of the pump 500 is connected with the gas analysis device 600, and the rear end of the gas analysis device 600 is connected with the second gas analysis device 600'; wherein the exhalation port assembly 100, the evacuation valve 300, the shunt valve 300', the three-way valve 400, and the pump 500 are all mounted on the mounting bracket 3. The flow sensor 200, the gas analysis device 600 and the second gas analysis device 600' are installed in the instrument lower cover 2; the control unit 800 is mounted on the instrument cover 1.
The device of example 2 (TM 2120-FeNO 50) was compared to the existing breath analyzer CA2122-FeNO 50.
(1) FeNO50 comparison verification is carried out, 29 total tests are compared (namely, a first verification experiment), and the average difference between TM2120-FeNO50 and CA2122-FeNO50 is-0.6 ppb (-10.9-9.8 ppb), and the correlation coefficient is 0.9674. Wherein, the difference data is shown in table 3, and the corresponding difference diagram is shown in fig. 8; the correlation coefficient data is shown in table 4, and the corresponding line graph is shown in fig. 9.
Table 3 example 2 difference data table for first verification experiment
/>
Table 4 example 2 correlation coefficient data table of first verification experiment
| Variable Y | CA2122FeNO50 |
| Variable X | TM2120-FeNO50 |
| Sample size | 29 |
| Correlation coefficient r | 0.9674 |
| Level of significance | P<0.0001 |
| 95% confidence interval (r) | 0.9310-0.9848 |
(2) The comparison verification of FeNO200 is carried out, 92 times of test comparison (namely a second verification experiment) are carried out, wherein the average difference between TM2120-FeNO200 and CA2122-FeNO200 is-0.4 ppb (-4.3-3.4 ppb), and the correlation coefficient is 0.9674. Wherein, the difference data is shown in table 5, and the corresponding difference diagram is shown in fig. 10; the correlation coefficient data is shown in table 6, and the corresponding line graph is shown in fig. 11.
Table 5 example 2 difference data table for the second validation experiment
/>
Table 6 example 2 correlation coefficient data table for the second verification experiment
| Variable Y | CA2122FeNO200 |
| Variable X | TM2120-FeNO200 |
| Sample size | 92 |
| Correlation coefficient r | 0.9152 |
| Level of significance | P<0.0001 |
| 95% confidence interval (r) | 0.8742-0.9432 |
(3) FeCO comparison verification is carried out, 31 total tests and comparisons (namely a third verification experiment) are carried out, and the average difference value of TM2120-FeCO and CA2122-FeCO is-1.5 ppm (-5.1-2.1 ppm), and the correlation coefficient is 0.9501. Wherein, the difference data is shown in table 7, and the corresponding difference diagram is shown in fig. 12; the correlation coefficient data is shown in table 8, and the corresponding line graph is shown in fig. 13.
Table 7 example 2 differential data table for the third validation experiment
/>
Table 8 example 2 correlation coefficient data table for the third verification experiment
| Variable Y | CA2122FeCO |
| Variable X | TM2120-FeCO |
| Sample size | 31 |
| Correlation coefficient r | 0.9501 |
| Level of significance | P<0.0001 |
| 95% confidence interval (r) | 0.8982-0.9759 |
The expired air nitric oxide measuring device of the embodiment consists of an expired air channel, a flow sensor, an evacuation valve, a three-way valve, a pump, a gas analysis device and a control unit. The flow sensor monitors the expiratory flow, and the evacuation valve and the three-way valve are connected into the expiratory channel in a bypass mode and are connected with the pump gas analysis device in series. A regression equation established by the physiological dead space determined by NO and parameters such as height, age, weight and the like is used for realizing intelligent setting of emptying time and sampling time; increasing the detection of the environmental NO, and adding the environmental NO to an association equation, so as to avoid the influence of the environmental NO on the test; the intelligent control of sampling time is realized, different people realize different expiration sampling time, realize accurate sampling. The integrated analysis device reduces the internal volume of the instrument; the high integration reduces the cost of the instrument.
In order to realize the corresponding device of the first embodiment to obtain the corresponding functions and technical effects, a method for measuring exhaled nitric oxide is provided below. The measuring method is used for the exhaled nitric oxide measuring device of the above embodiment.
The method comprises the following steps: zero point test procedure and sample gas test procedure.
The zero point test process comprises the following steps:
and opening the three-way valve to extract air into the gas analysis device, and analyzing the gas concentration of the air by the gas analysis device so as to realize zero point test.
After the zero point test, the sample gas test procedure is started.
The sample gas testing process includes:
introducing a sample gas through an exhalation passage assembly; the sample gas is a test gas exhaled by the subject.
The control unit is used for closing the three-way valve and opening the evacuation valve after the sample gas is introduced into the expiration channel device, so that the evacuation valve starts to discharge the introduced sample gas until the evacuation time is reached, and closing the evacuation valve and opening the three-way valve; and the three-way valve is used for introducing the sample gas discharged by the emptying valve into the gas analysis device.
Wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined based on the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject.
And the gas analysis device performs gas concentration division on the introduced sample gas to obtain a sample analysis result.
The control unit determines the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result.
Wherein, the formula of the evacuation time is:
wherein T is 0 Indicating the evacuation time; v (V) D Representing the volume of a physiological dead space; q represents the flow of test gas exhaled by the subject.
If the sex of the subject is male, the calculation formula of the volume of the physiological dead space is as follows:
wherein V is I Representing the volume of test gas inhaled by the subject; FA (FA) NO (t 1 ) Indicating the concentration of nitric oxide in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide in the test gas exhaled by the subject; age represents the Age of the subject; height represents the body weight of the subject; t is t 1 Indicating the time at which the subject inhaled the test gas; t is t 2 Indicating the time at which the subject exhales the test gas; t is t 2 -t 1 Indicating an expiration measurement period.
If the sex of the subject is female, the calculation formula of the volume of the physiological dead space is as follows:
in the present specification, each embodiment is described in a progressive manner, and each embodiment is mainly described in a different point from other embodiments, and identical and similar parts between the embodiments are all enough to refer to each other. For the method disclosed in the embodiment, since it corresponds to the device disclosed in the embodiment, the description is relatively simple, and the relevant points are referred to the device part description.
The principles and embodiments of the present invention have been described herein with reference to specific examples, the description of which is intended only to assist in understanding the methods of the present invention and the core ideas thereof; also, it is within the scope of the present invention to be modified by those of ordinary skill in the art in light of the present teachings. In view of the foregoing, this description should not be construed as limiting the invention.
Claims (9)
1. An exhaled nitric oxide measurement device, comprising: the device comprises an expiration channel device, a three-way valve, an evacuation valve, a gas analysis device and a control unit;
the output end of the expiration channel device is respectively connected with the first ends of the evacuation valve and the three-way valve; the second end of the three-way valve is connected with the gas analysis device; the gas analysis device is connected with the control unit;
the three-way valve is used for pumping air into the gas analysis device;
the gas analysis device is used for analyzing the gas concentration of the air to realize zero point test;
the expiration channel device is used for introducing sample gas after zero point test; the sample gas is a test gas exhaled by the subject;
the control unit is also used for controlling the three-way valve to be closed and the evacuation valve to be opened after the sample gas is introduced into the expiration channel device, so that the evacuation valve starts to discharge the introduced sample gas until the evacuation time is reached, and controlling the evacuation valve to be closed and the three-way valve to be opened;
wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined according to the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject;
the three-way valve is also used for introducing the sample gas discharged by the emptying valve into the gas analysis device;
the gas analysis device is also used for carrying out gas concentration analysis on the introduced sample gas to obtain a sample analysis result;
the control unit is also used for determining the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result.
2. The exhaled nitric oxide measurement device according to claim 1, wherein said evacuation time is calculated by the formula:
wherein T is 0 Indicating the evacuation time; v (V) D Representing the volume of a physiological dead space; q represents the flow of test gas exhaled by the subject;
if the sex of the subject is male, the calculation formula of the volume of the physiological dead space is as follows:
wherein V is I Representing the volume of test gas inhaled by the subject; FA (FA) NO (t 1 ) Indicating the concentration of nitric oxide in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide in the test gas exhaled by the subject; age represents the Age of the subject; height represents the body weight of the subject; t is t 1 Indicating the time at which the subject inhaled the test gas; t is t 2 Indicating the time at which the subject exhales the test gas; t is t 2 -t 1 Representing an expiration measurement period;
if the sex of the subject is female, the calculation formula of the volume of the physiological dead space is as follows:
3. the exhaled nitric oxide measurement device of claim 1, further comprising: a diverter valve; the shunt valve is connected with the expiration channel device; the control unit is also used for controlling the diverter valve to be opened when the flow rate of the sample gas is larger than a set flow rate value, and the diverter valve and the emptying valve are used for discharging the introduced sample gas together until the emptying time is reached.
4. The exhaled nitric oxide measurement device according to claim 1, wherein said gas analyzing means is at least one; different gas analysis devices analyze the concentration of different gas components in the introduced sample gas; at least one gas analysis device analyzes the concentration of nitric oxide in the introduced sample gas.
5. The exhaled nitric oxide measurement device of claim 1, further comprising: a filter; the third end of the three-way valve is connected with the filter; the filter is used for leading the filtered air into the gas analysis device through the three-way valve.
6. The exhaled nitric oxide measurement device of claim 1, further comprising: a pump; the second end of the three-way valve is connected with the gas analysis device through the pump.
7. The exhaled nitric oxide measurement device of claim 1, further comprising: a flow sensor; the flow sensor is connected with the expiration channel device; the flow sensor is used for measuring the flow of test gas exhaled by the subject.
8. An exhaled nitric oxide measurement method, characterized in that the measurement method is used for an exhaled nitric oxide measurement device according to any of claims 1-7; the method comprises the following steps: a zero point test process and a sample gas test process;
the zero point test process comprises the following steps:
opening a three-way valve to extract air into the gas analysis device, and analyzing the gas concentration of the air by the gas analysis device to realize zero point test;
after the zero point test, starting a sample gas test process;
the sample gas testing process includes:
introducing a sample gas through an exhalation passage assembly; the sample gas is a test gas exhaled by the subject;
the control unit is used for closing the three-way valve and opening the evacuation valve after the sample gas is introduced into the expiration channel device, so that the evacuation valve starts to discharge the introduced sample gas until the evacuation time is reached, and closing the evacuation valve and opening the three-way valve; the three-way valve is used for introducing the sample gas discharged by the emptying valve into the gas analysis device;
wherein the evacuation time is the time for which the gases within the physiological dead space of the subject are all evacuated; the evacuation time is determined according to the sex, age, weight of the subject, volume of test gas inhaled by the subject, concentration of nitric oxide in test gas exhaled by the subject, and flow rate of test gas exhaled by the subject;
the gas analysis device analyzes the gas concentration of the introduced sample gas to obtain a sample analysis result;
the control unit determines the concentration of nitric oxide in the sample gas according to the zero point test result and the sample analysis result.
9. The method of exhaled nitric oxide measurement according to claim 8, wherein said evacuation time is calculated by the formula:
wherein T is 0 Indicating the evacuation time; v (V) D Representing the volume of a physiological dead space; q represents the flow of test gas exhaled by the subject;
if the sex of the subject is male, the calculation formula of the volume of the physiological dead space is as follows:
wherein V is I Representing the volume of test gas inhaled by the subject; FA (FA) NO (t 1 ) Indicating the concentration of nitric oxide in the test gas inhaled by the subject; FA (FA) NO (t 2 ) Indicating the concentration of nitric oxide in the test gas exhaled by the subject; age represents the Age of the subject; height represents the body weight of the subject; t is t 1 Indicating the time at which the subject inhaled the test gas; t is t 2 Indicating the time at which the subject exhales the test gas; t is t 2 -t 1 Representing an expiration measurement period;
if the sex of the subject is female, the calculation formula of the volume of the physiological dead space is as follows:
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