WO2022121353A1 - Fractional exhaled nitric oxide measurement instrument - Google Patents

Abstract

A fractional exhaled nitric oxide measurement instrument, comprising an exhalation device; a measurement gas passage that is in communication with the exhalation device by means of an exhalation tube and is used for allowing gas to be subjected to measurement to circulate therein and for measuring the concentration of nitric oxide in the gas to be subjected to measurement; and a zeroing gas passage for realizing gas zeroing. The measurement instrument further comprises: a circuit part for controlling the on/off and path connection/disconnection of the measurement gas passage and the zeroing gas passage, and for controlling filtering and amplification, analysis and transmission of data; and a power supply for supplying power, and a display screen. In the present invention, the zeroing gas passage and the measurement gas passage can be automatically switched to measure the concentration of nitric oxide, thereby significantly improving the measurement precision and efficiency of nitric oxide.

Description

Exhaled breath nitric oxide detector

This application claims the priority of the Chinese patent application filed on December 11, 2020 with the application number 202011453242.8 and the invention titled "An Exhaled Breath Nitric Oxide Detector", the entire contents of which are incorporated herein by reference Applying.

technical field

The invention relates to the technical field of medical devices, and more particularly, to an exhaled breath nitric oxide detector.

Background technique

Exhaled nitric oxide (Fractional exhalednitric oxide, FeNO) is considered to be a sensitive indicator of eosinophilic inflammation in the airways, and FeNO detection methods have been used to assess and predict patient response to anti-inflammatory therapy, as well as to monitor patient compliance . There are currently three mainstream detectors for FeNO detection: chemiluminescence detector, electrochemical detector, and laser detector.

At present, most of the electrochemical nitric oxide detectors on the market use a single gas path for detection, lacking a zero-returning gas path, and the detector needs to be restarted or reset to zero in a nitric oxide (NO)-free environment. When the zeroing is inaccurate, it will easily affect the measurement accuracy of the nitric oxide detector. In clinical trials, FeNO concentrations of <20ppb in children are considered normal levels, 20-35ppb are considered mild inflammation, and >35ppb are considered severe inflammation; FeNO concentrations in adults <25ppb are considered normal levels, and 25-50ppb are considered mild inflammation. >50ppb belongs to severe inflammation, so the detection accuracy of medical exhaled nitric oxide detector is high.

SUMMARY OF THE INVENTION

The purpose of the present invention is to provide an exhaled nitric oxide detector, which provides a dual gas path detection mode and improves the detection accuracy of the nitric oxide detector.

The invention provides an exhaled breath nitric oxide detector, comprising an exhalation device;

Detecting the air path, communicated with the exhalation device through the expiratory tube;

Zero adjustment gas circuit to achieve gas zero adjustment;

The detection gas path and the zero-adjusting gas path are automatically switched through the valve assembly;

a circuit part, used to be electrically connected with the detection gas circuit and the zero-adjustment gas circuit to control the start-stop of the detection gas circuit and the zero-adjustment gas circuit, the on-off of the path, and the control of filter amplification, analysis and transmission of data;

a display screen for communicating with the circuit part to display measurement data;

The power supply is used to supply power to the detection gas circuit, the zero adjustment gas circuit, the circuit part and the display screen.

Preferably, the exhalation device includes a disposable mouthpiece, a disposable filter for filtering bacteria and water vapor, and an inhalation handle for removing nitric oxide, and the bottom of the inhalation handle is provided with several inhalers The inside of the suction handle is provided with a zero-pressure one-way valve and is filled with oxide.

Preferably, the disposable filter includes an upper cover, a lower cover and a filter membrane made of a hydrophobic material of three layers of polyene electret synthetic fibers.

Preferably, both the disposable mouthpiece and the suction handle are connected to the disposable filter by means of plugging and unplugging.

Preferably, the detection gas path includes a first three-way valve, a second three-way valve, an air pump, a drying pipe and a nitric oxide sensor connected in sequence through an air pipe, and the exhalation device is connected with the first three-way valve. The gas storage chamber is connected to the gas storage chamber through a trachea, and a pipe gripper for controlling the on-off of the gas storage chamber is installed on the trachea between the exhalation device and the first three-way valve.

Preferably, the zero-adjusting gas circuit includes a nitric oxide removal chamber, the first three-way valve, the second three-way valve, the air pump, the drying pipe, the For a nitric oxide sensor, the nitric oxide removal chamber is provided with an air inlet that communicates with the outside world; the interior of the nitric oxide removal chamber is filled with potassium permanganate.

Preferably, the circuit part includes a filter amplifying circuit, a data analysis and processing circuit, a data transmission circuit and a control circuit, and the filter amplifying circuit is composed of three nitric oxide electrochemical sensor filter and amplifying circuits connected in parallel and a filter and amplifying circuit on the main circuit. The circuit is constituted; the circuit part is respectively electrically connected with the pipe gripper, the first three-way valve, the air pump, the nitric oxide sensor and the display screen.

Preferably, a constant flow valve is installed between the exhalation device and the detection air path, the constant flow valve is respectively connected to the first air pressure detection sensor and the second air pressure detection sensor through the air pipe, and the circuit part is connected to the first air pressure detection sensor. An air pressure detection sensor, the second air pressure detection sensor and the second three-way valve are connected.

Preferably, the nitric oxide sensor is three nitric oxide electrochemical sensors connected in parallel.

Preferably, the gas storage chamber is spirally folded by a gas storage tube to form a helical cube.

Compared with the above-mentioned background technology, the exhaled nitric oxide detector provided by the present invention includes an exhalation device, a detection air circuit, a zero adjustment air circuit, a circuit part, a display screen and a power supply, wherein the exhalation device, the detection air The gas collection part is composed of the gas circuit and the zero-adjusting gas circuit. The detection gas circuit is used to circulate and detect the nitric oxide concentration of the gas to be tested. The zero-adjusting gas circuit is used to realize the zero-adjustment of the detection system. The detection gas circuit and the zero-adjusting gas circuit pass through the valve. Components implement automatic switching. The present application can realize the independent switching of the zero-setting gas circuit and the detection gas circuit by connecting the valve assembly of the circuit part and the built-in autonomous coding program, and realize the detection method of dual gas circuits. Specifically, before the test, the tester exhales into the exhalation device, and detects the flow rate and flow of the exhaled gas through the detection air circuit, the circuit part and the display screen, so that the system can reach the response value; when the zero is adjusted, the external ambient gas enters Inside the detector, the gas is zero-adjusted through the zero-adjusting gas circuit. Then, the gas to be tested is detected by the detection gas circuit to realize the concentration of nitric oxide. The detected electrical signal is filtered, amplified, analyzed and processed by the circuit and transmitted to the display after data conversion. The screen realizes visualization, which can effectively improve the detection accuracy of the detector.

Description of drawings

In order to explain the embodiments of the present invention or the technical solutions in the prior art more clearly, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. Obviously, the accompanying drawings in the following description are only It is an embodiment of the present invention. For those of ordinary skill in the art, other drawings can also be obtained according to the provided drawings without creative work.

1 and 2 are schematic diagrams of the exhaled nitric oxide detector provided by the present invention.

Among them, 1-disposable mouthpiece, 2-disposable filter, 3-suction handle, 4-constant flow valve, 5-pipe gripper, 6-first air pressure detection sensor, 7-first three-way valve, 8-Second three-way valve, 9-Air pump, 10-Drying pipe, 11-Nitric oxide sensor, 12-Circuit part, 13-Second air pressure detection sensor, 14-Power supply, 15-Gas storage chamber, 16-One Nitric oxide removal chamber, 17-display.

Detailed ways

In order to make those skilled in the art better understand the solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

Please refer to FIG. 1 and FIG. 2 . FIG. 1 and FIG. 2 are schematic diagrams of the exhaled nitric oxide detector provided by the present invention.

The present invention provides an exhaled breath nitric oxide detector, which mainly includes an exhalation device, a detection air circuit, a zero adjustment air circuit, a valve assembly, a circuit part 12, a display screen 17 and a power supply 14, and the above components are installed inside the casing .

Among them, the exhalation device is used for the user to blow air into the mouth, the detection air circuit is connected with the exhalation device through the exhalation tube, and the detection air circuit is used to circulate and detect the nitric oxide concentration of the gas to be measured, and the zero adjustment air circuit The gas pipe is connected to the detection gas circuit, and the zero adjustment gas circuit can realize the gas zero adjustment. Under the control of the built-in coding program, the independent switching of the detection gas circuit and the zero adjustment gas circuit can be realized through the valve assembly.

The circuit part 12 is electrically connected with the detection gas circuit, the zero-adjusting gas circuit and the display screen 17 to test the flow rate and flow rate of the exhaled air to make the system reach a stable value, and to control the gas zero adjustment and exhaled nitric oxide concentration during detection. automatic high-precision detection.

The display screen 17 is connected in communication with the circuit part 12 , the circuit part is specifically a single-chip microcomputer, and the circuit part 12 transmits the measurement data to the display screen 17 , and realizes the visualization of the measurement data through the display screen 17 .

The above-mentioned detection gas path, zero adjustment gas path, circuit part 12 and display screen 17 are all powered by the power supply 14 .

During the test, the external ambient gas enters the zero-adjusting air circuit, and the nitric oxide gas in the air is removed through the zero-adjusting air circuit, thereby obtaining the zero-adjusting gas without nitric oxide; The zero-adjusting gas circuit realizes the zero-setting of the system to ensure the accuracy of the subsequent test results; the gas to be tested can automatically detect the nitric oxide concentration of the exhaled gas to be tested through the detection gas circuit and the circuit part. During the above test process, the self-switching between the zero-setting gas circuit and the detection gas circuit can be realized by connecting the valve assembly of the circuit part and the built-in autonomous coding program, thereby realizing dual gas circuit detection.

The above-mentioned exhalation device includes a disposable mouthpiece 1 , a disposable filter 2 and an inhalation handle 3 .

The disposable mouthpiece 1 is preferably made of polypropylene and is a medical-grade sterile mouthpiece. When the tester blows air to the disposable mouthpiece 1, the gas passes through the disposable filter 4 to filter out bacteria and moisture in the gas. Then, the nitric oxide in the gas is removed through the suction handle 3.

The disposable filter 2 is used to filter bacteria and moisture.

In addition, the suction handle 3 is connected to the zero-adjusting air circuit and the detection air circuit, and the disposable nozzle 1, the disposable filter 2 and the suction handle 3 are connected in sequence. The bottom of the suction handle 3 is provided with a number of suction holes, and the interior of the suction handle 3 is provided with a zero-pressure one-way valve and is filled with oxides. When the gas enters the suction handle 3, the oxides oxidize the nitric oxide in the gas. It is nitrogen dioxide, so as to obtain zero-adjusting gas without nitrogen monoxide, so as to ensure the accuracy of the test results in the detection process.

In addition, the above-mentioned disposable filter 2 includes an upper cover, a lower cover and a filter membrane. The filter membrane is made of a hydrophobic material of three-layer polyolefin electret synthetic fiber. It is set in the installation cavity, and the filter membrane is used to filter bacteria and water vapor. Repeated tests can be realized by replacing the filter membrane.

During installation, the outer diameter of the lower end of the disposable mouthpiece 1 is equal to the inner diameter of the upper end of the disposable filter 2, the mouthpiece is just inserted into the upper end of the disposable filter 2, and the inner diameter of the top of the suction handle 3 is the same as that of the disposable filter 2. The outer diameter of the lower end of the filter is the same. The disposable mouthpiece 1 and the inhalation handle 3 can be plugged and connected to the disposable filter 2 by plugging and unplugging, and the three can also be threadedly connected. filter.

In a specific embodiment, the detection air circuit includes a first three-way valve 7, a second three-way valve 8, an air pump 9, a drying pipe 10 and a nitric oxide sensor 11 connected in sequence through an air pipe. A gas storage chamber 15 and a pipe gripper 5 are also provided between the three-way valve 7 , and the circuit part 12 is respectively connected with the constant flow valve 4 , the pipe gripper 5 , the first three-way valve 7 , the air pump 9 and the nitric oxide sensor 11 . .

In addition, the above-mentioned zero-adjusting gas circuit includes a nitric oxide removal chamber 16, a first three-way valve 7, a second three-way valve 8, an air pump 9, a drying pipe 10 and a nitric oxide sensor 11, which are connected in sequence through pipelines. The nitrogen oxide removal chamber 16 is provided with an air inlet that communicates with the outside, and the interior of the nitrogen monoxide removal chamber 16 is filled with potassium permanganate.

The nitric oxide sensor 11 is preferably composed of three sensors connected in parallel through a circuit as a nitric oxide detection module. The gas storage chamber 15 is formed by folding a 2 m long gas storage tube; the diameter of the gas storage tube is 1 cm. The drying tube 10 is a thin tube having a length of 30 cm and a diameter of 0.2 cm, and contains a desiccant.

In addition, the circuit part 12 includes a filter amplifying circuit, a data analysis and processing circuit, a data transmission circuit and a control circuit. The filter and amplifying circuit is composed of three nitric oxide electrochemical sensor filter and amplifying circuits connected in parallel and a filter and amplifying circuit on the main circuit. The parts 12 are respectively electrically connected with the pipe gripper 5 , the first three-way valve 7 , the air pump 9 , the nitric oxide sensor 11 and the display screen 17 .

During the exhalation test before the test, the exhaled gas flows through the constant flow valve 4, the second three-way valve 8, and the drying pipe 10, and reaches the nitric oxide sensor 11 for flow rate and flow detection. During this process, the tester can carry out Exhalation pre-test, the tester takes a deep breath, blows the breath to the mouth according to a certain flow rate and flow, and monitors whether the response value is reached. After the pre-test is successful, the test can be carried out until the system reaches the response value. The nitric oxide sensor 11 is stable. After the test, the circuit unit 12 controls the air pump 9 to start, and controls the first three-way valve 7 to communicate with the nitric oxide removal chamber 16. At this time, the outside air enters the nitric oxide removal chamber 16 through the air inlet, and the air is removed by potassium permanganate. After the nitric oxide in the gas is oxidized, a zero-adjusting gas without nitric oxide is obtained. Under the pressure of the air pump 9, the zero-adjusting gas flows through the nitric oxide sensor 11 through the first three-way valve 7, the second three-way valve 8, and the drying pipe 10 for detection, and the nitric oxide sensor 11 transmits the detection result to the nitric oxide sensor 11. The microprocessor of the circuit section 12 serves as the zero-setting electrical signal.

After the zero adjustment is completed, during the formal detection, the circuit part 12 opens the pipe gripper 5, the gas to be measured is collected into the gas storage chamber 15, the circuit part 12 controls the first three-way valve 7 to communicate with the gas storage chamber 15, and the air pump 9 sends the gas to be measured. The gas is pumped to the drying tube 10, and the dried gas to be tested enters the nitric oxide sensor 11 for detection. The respective electrical signals of the three nitric oxide sensors 11 first pass through their respective filtering and amplifying circuits, and then merge into the electrical signals of the main circuit. , filter and amplify the circuit, and then processed by the data analysis and processing circuit, convert the electrical signal into a data signal through the A/D digital-to-analog converter in the data analysis and processing circuit, and transmit it to the display screen 17 through the data transmission circuit for display. .

On the basis of the above embodiment, a constant flow valve 4 can be installed between the exhalation device and the detection air path, and the constant flow valve 4 is respectively connected to the first air pressure detection sensor 6 and the second air pressure detection sensor 13 through the trachea, and the circuit part 12 It is connected to the first air pressure detection sensor 6 , the second air pressure detection sensor 13 and the second three-way valve 8 .

The filtered exhaled air flows through the constant flow valve 4 through the exhalation tube. At this time, the air pressure of the gas to be measured is detected by the first air pressure detection sensor 6, and the detected electrical signal is processed by the filter and amplifying circuit, and then transmitted to the device. The microprocessor in the data analysis and processing circuit starts the pipe gripper 5 after analysis by the microprocessor, and the gas to be measured enters the gas storage chamber 15. At the same time, the gas to be measured is detected by the second air pressure detection sensor 13, and the The electrical signal is transmitted to the microprocessor, and the microprocessor adjusts the valve of the constant flow valve 4 in real time after analysis, so as to ensure that each detector blows the same amount of gas in the same time. It can be seen that, in this embodiment, the constant flow of the exhaled breath can be made to flow into the gas storage chamber 15 through the cooperation of the constant flow valve 4 and the air pressure detection sensor, so as to achieve the effect of stabilizing the flow.

Preferably, the gas storage chamber 15 is spirally folded by a gas storage tube to form a helical cube.

The working process of the exhaled nitric oxide detector provided by the present invention is as follows: install a disposable mouthpiece 1 and a disposable filter 2, turn on the detector; perform a breath test, and the exhaled gas passes through the constant flow valve 4, the second and third The through valve 8 and the drying pipe 10 reach the nitric oxide sensor 11 for detection until the system reaches the response value; the detector first inhales, the air enters through the inhalation hole at the bottom of the inhalation handle 3, and the nitric oxide in the air is removed. The oxide inside the inhalation handle 3 is oxidized to nitrogen dioxide to remove nitric oxide gas in the gas; blow air to the disposable mouthpiece 1, and the exhaled gas to be tested passes through the filter membrane of the disposable filter 2 to remove the exhaled gas. Moisture, bacteria, etc. in the air; the filtered gas enters the constant flow valve 4, the first air pressure detection sensor 6 detects the air pressure of the filtered gas in the constant flow valve 4, and when the preset air pressure value is reached, the circuit part 12 opens the pipe clamp 5, and the gas Enter the gas storage chamber 15 for storage; at the same time, the second air pressure detection sensor 13 detects the gas synchronously, and the circuit part 12 adjusts the valve opening of the constant flow valve 4 according to the air pressure value to realize constant gas flow control. After that, the system zero adjustment and the nitric oxide detection of the gas to be measured are realized under the control of the air pump 9 .

It should be noted that, in this specification, relational terms such as first and second are only used to distinguish one entity from several other entities, and do not necessarily require or imply any such existence between these entities. The actual relationship or sequence.

The exhaled breath nitric oxide detector provided by the present invention has been described in detail above. The principles and implementations of the present invention are described herein by using specific examples, and the descriptions of the above embodiments are only used to help understand the method and the core idea of the present invention. It should be pointed out that for those skilled in the art, without departing from the principle of the present invention, several improvements and modifications can also be made to the present invention, and these improvements and modifications also fall within the protection scope of the claims of the present invention.

Claims (10)

1. An exhaled breath nitric oxide detector is characterized in that, comprising:

   exhalation device;

   a detection air circuit, communicated with the exhalation device through an exhalation pipe, and the detection air circuit is used for circulating and detecting the nitric oxide concentration of the gas to be measured;

   Zero adjustment gas circuit to achieve gas zero adjustment;

   The detection gas path and the zero-adjusting gas path are automatically switched through the valve assembly;

   A circuit part (12) is used to be electrically connected with the detection gas circuit and the zero-adjustment gas circuit to control the start-stop of the detection gas circuit and the zero-adjustment gas circuit, the on-off of the path, and the control of filter amplification, analysis and control. transfer data;

   a display screen (17) for communicating with the circuit part (12) to display measurement data;

   A power supply (14) is used to supply power to the detection gas circuit, the zero-adjustment gas circuit, the circuit part (12) and the display screen (17).
2. The exhaled nitric oxide detector according to claim 1, wherein the exhalation device comprises a disposable mouthpiece (1), a disposable filter (2) for filtering bacteria and moisture, and a In order to remove the suction handle (3) of nitric oxide, the bottom of the suction handle (3) is provided with a number of suction holes, and the inside of the suction handle (3) is provided with a zero-pressure one-way valve and is filled with oxide.
3. The exhaled nitric oxide detector according to claim 2, wherein the disposable filter (2) comprises an upper cover, a lower cover and a three-layer polyolefin electret synthetic fiber hydrophobic material made of filter membrane.
4. The expired nitric oxide detector according to claim 3, wherein the disposable mouthpiece (1) and the inhalation handle (3) are connected to the disposable filter (3) by means of plugging and unplugging. 2) Connect.
5. The exhaled breath nitric oxide detector according to claim 1, wherein the detection gas path comprises a first three-way valve (7), a second three-way valve (8), an air pump ( 9), a drying pipe (10) and a nitric oxide sensor (11), a gas storage chamber (15) is connected between the exhalation device and the first three-way valve (7) through a trachea, the exhalation device A pipe clamp (5) for controlling the on-off of the gas storage chamber (15) is installed on the gas pipe between the first three-way valve (7).
6. The exhaled nitric oxide detector according to claim 5, characterized in that, the zero-adjusting gas path comprises a nitric oxide removal chamber (16), the first three-way valve (16) and the first three-way valve ( 7) The second three-way valve (8), the air pump (9), the drying pipe (10) and the nitric oxide sensor (11), the nitric oxide removal chamber (16) is provided with There is an air inlet communicated with the outside; the inside of the nitric oxide removal chamber (16) is filled with potassium permanganate.
7. The exhaled breath nitric oxide detector according to claim 6, characterized in that the circuit part (12) comprises a filter amplifying circuit, a data analysis and processing circuit, a data transmission circuit and a control circuit, and the filter and amplifying circuit is connected in parallel Three nitric oxide electrochemical sensors filter amplifying circuits and filter amplifying circuits on the main circuit are formed; the circuit part (12) is respectively connected with the pipe clamp (5) and the first three-way valve (7) , the air pump (9), the nitric oxide sensor (11) and the display screen (17) are electrically connected.
8. The exhaled nitric oxide detector according to any one of claims 5 to 7, characterized in that a constant flow valve (4) is installed between the exhalation device and the detection air path, and the constant flow valve (4) The first air pressure detection sensor and the second air pressure detection sensor are respectively connected through the air pipe, and the circuit part (12) is connected with the first air pressure detection sensor, the second air pressure detection sensor and the second three-way valve. (8) Connected.
9. The exhaled nitric oxide detector according to claim 5, wherein the nitric oxide sensor (11) is three parallel nitric oxide electrochemical sensors.
10. The exhaled breath nitric oxide detector according to claim 5, characterized in that, the gas storage chamber (15) is spirally folded by a gas storage tube to form a helical cube.

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