CN113633273A

CN113633273A - Breath detection filter device, mouthpiece and breath detection method for preventing cross contamination

Info

Publication number: CN113633273A
Application number: CN202010346890.7A
Authority: CN
Inventors: 王天星; 章子毅; 胡锡江; 江亮; 徐传曙
Original assignee: Zhejiang E Linkcare Medical Technology Co ltd
Current assignee: Zhejiang E Linkcare Medical Technology Co ltd
Priority date: 2020-04-27
Filing date: 2020-04-27
Publication date: 2021-11-12

Abstract

The invention provides an expiration detection filtering device for preventing cross contamination, a mouthpiece matched with the expiration detection filtering device and an expiration detection method. The filter device includes a mouthpiece and a device body, the mouthpiece being removably attachable to the device body. The mouthpiece comprises an expiration channel and an inspiration channel, a one-way valve is arranged on the inspiration channel, and an opening and closing device is arranged on the expiration channel. The exhalation passage and the inhalation passage of the mouthpiece are respectively and mutually corresponding to the exhalation passage and the inhalation passage of the device main body and are tightly connected without air leakage. The mouthpiece in the filter device is used by a single person, so that the pollution of an air suction channel of a device body used by a plurality of persons can be avoided, the aim of preventing cross pollution in the process of breath detection of exhaled nitric oxide and the like is fulfilled, and the filter device is very suitable for clinical popularization and application.

Description

Breath detection filter device, mouthpiece and breath detection method for preventing cross contamination

Technical Field

The invention relates to the field of exhaled gas detection, in particular to a filter device, a mouthpiece and a detection method for preventing cross contamination.

Background

As early as the 18 th century, researchers found that differences in exhaled breath of humans are predictive of the occurrence of certain diseases. With the development of modern medical technology, more and more disease-related markers are found in exhaled breath, and currently, exhaled breath detection is widely used in clinical research and clinical diagnosis, and the detection range covers Volatile Organic Compounds (VOCs) in exhaled breath, Exhaled Breath Condensate (EBC), particulate matters in exhaled breath, and the like. Organic compounds in exhaled breath that have been used in clinical tests include nitric oxide, carbon monoxide, hydrogen, methane, ammonia, hydrogen sulfide, oxygen, and carbon dioxide.

Exhaled nitric oxide (FeNO) has been widely used in clinical tests as an internationally recognized noninvasive detection marker for Eosinophilic (EOS) airway inflammation. According to the technical standard of exhaled nitric oxide detection, which is established by the united states thoracic society (ATS) and European Respiratory Society (ERS) in 2005, it is recommended that air without nitric oxide (<5ppb) be inhaled before detection, and then exhaled for detection, so as to avoid the influence of nitric oxide in ambient gas on the detection result. It is common in the prior art to provide a filtration device containing nitric oxide removal material in the inspiratory pathway for the purpose of inhaling no nitric oxide (<5ppb) air; set up filter equipment in exhaling the route simultaneously in order filtering contaminants such as food waste, particulate matter, droplet, bacterium, avoid polluting detection passageway and equipment, nevertheless still have the risk of passing through to virus or small molecule pollutant.

Chinese patent No. CN104244819B discloses a hand-held unit and an exhaled breath analyzing apparatus, which includes an inhalation hole, an inhalation path, an exhaled breath discharging unit, an exhalation path, and a bending unit. The risk that the pipeline connected with the analysis main body is damaged in use is reduced through the bending part. The device is provided with a filtering part in an inspiration path, and two groups of one-way valves are arranged in front of and behind the filtering part and used for opening and closing the filtering part during inspiration or expiration. The disadvantage of this technique is that the inhalation inlet portion 11 and exhalation discharge portion 13 of the device are effectively the same gas flow portion and the second inhalation path and discharge path are effectively the same gas flow portion. Since the exhalation path and inhalation path in the device share a common part and the hand-held part is used multiple times, this leads to the risk of cross-contamination when multiple people share one hand-held part.

Chinese patent publication No. CN105388278B discloses a hand-held respiratory filtration device, which is divided into an inhalation passage and an exhalation passage. The air suction passage comprises an opening, a filter cavity, a middle partition plate with a one-way valve, humidifying paper and a blowing nozzle; when inhaling, the one-way valve is opened, and the gas can enter the human body; when exhaling, the one-way valve is closed, and the gas can not enter the inhalation channel such as the filter cavity. However, the check valve of this device is provided in the main structure of the respiratory filter device, and the main structure part where the exhaled gas inevitably reaches the check valve during exhalation, for example, the mouthpiece 17, the humidifying paper 10, and the like are shared parts of the inhalation passage and the exhalation passage, and the exhaled gas passes through these shared parts, and if a contamination source in the exhaled gas remains in these shared parts. Since the hand-held respiratory filtration device is used by multiple persons, when the next tester is used again, the residual pollution source remained at the shared part can enter the human body along with the inhalation of the tester. There is also a risk of cross-contamination when used by different people.

Expiration check out test set, including detecting instrument main part and expiration filter equipment, based on the frequency of use and the consideration of cost, all use many people at present. During detection, the exhaled gas needs to enter a detection instrument through the device; for detection indexes such as nitric oxide and the like, gas needs to be sucked through the filtering device before detection, so that great cross contamination risks exist. In recent years, infectious diseases transmitted by the respiratory system have frequently appeared in the world, so that the exhalation test equipment is designed to prevent the risk of cross contamination, and is particularly important for the safety of the clinical application of the equipment.

Disclosure of Invention

In order to overcome the problems and defects in the prior art, the invention provides a filter device, a mouthpiece and a detection method for preventing cross contamination, and aims to eliminate the risk of cross contamination in practical application and multi-user use of the device.

One of the objects of the present invention is a filtering device for breath detection, comprising a device body including a housing, an inhalation passage and an exhalation passage provided in the housing, a gas in the exhalation passage being unable to enter the inhalation passage; one end of the device main body comprises an air inlet which is in gas communication with an air suction channel of the device main body; the mouthpiece is detachably arranged at the other end of the device main body and comprises a shell, an air suction channel and an air expiration channel are arranged in the shell, and after the mouthpiece is arranged, the air expiration channel and the air inspiration channel of the mouthpiece correspond to the air expiration channel and the air inspiration channel of the device main body respectively and are combined in an air-tight manner; the inhalation passage of the mouthpiece is provided with a one-way valve, when inhaling, the one-way valve on the inhalation passage is opened to open the inhalation passage, and when exhaling, the one-way valve on the inhalation passage is closed to close the inhalation passage; the breathing device also comprises an exhalation channel opening and closing device, wherein when breathing, the opening and closing device is closed, and the exhalation channel is in a closed state.

The one-way valve on the exhalation passage of the device main body, the one-way valve on the mouthpiece exhalation passage and the electromagnetic valve on the detection instrument communicated with the filtering device can be used as the opening and closing device of the exhalation passage. When the patient exhales, the one-way valve is opened and/or the electromagnetic valve is opened to open the exhalation passage; on inhalation, the one-way valve closes and/or the solenoid valve closes to close the breathing passage. Other structures with the opening and closing of the air passage also belong to the opening and closing device.

For example, a breath detection filter device for preventing cross-contamination includes a mouthpiece for a single person to use, detachably mounted to a device body, and the device body is usable by a plurality of persons. The mouthpiece consists of a shell, and an expiration channel and an inspiration channel which are arranged in the shell. The device main body is composed of a shell, and an expiration channel and an inspiration channel which are arranged in the shell, wherein the expiration channel and the inspiration channel are independent. When the mouthpiece is mounted on the device body, the exhalation passage and the inhalation passage of the mouthpiece correspond to and are airtightly combined with the exhalation passage and the inhalation passage of the device body, respectively. The suction channel of the mouthpiece at least comprises a one-way valve, and the one-way valve is opened only during suction, so that gas can be sucked into a human body through the mouthpiece; and when exhaling the check valve closes, the breathing gas can not get into the inhalant canal of device main part through the inhalant canal of mouthpiece, avoids causing the pollution of device main part inhalant canal that many people used.

According to the technical scheme of the invention, after the mouthpiece and the device main body are installed, the public space or interface does not exist in the exhalation path and the inhalation path of the device main body effectively and thoroughly, and the public space is only reserved on the mouthpiece special for a single person, so that the aim of thoroughly avoiding cross contamination is fulfilled.

The one-way valve can be made of flexible plastic or silica gel materials, is made into an umbrella shape, a T shape or a buckle shape, and is arranged on the mouthpiece or a partition plate in the device main body. When the patient exhales and inhales, the main body part of the one-way valve is stressed to tilt upwards under the positive acting force of the expiratory pressure or the inspiratory negative pressure, and the channel is opened; when not exhaling or inhaling, the one-way valve recovers to the initial position and is attached to the air holes of the one-way valve installation clapboard, when the counterforce of exhaling or inhaling is received, the main body part of the one-way valve is attached to the air holes more tightly, and the gas can only flow in a single direction.

One of the purposes of the invention is to provide a mouthpiece which comprises a shell, wherein an inspiration channel and an expiration channel are arranged in the shell, a one-way valve is arranged on the inspiration channel, the one-way valve on the inspiration channel is opened to open the inspiration channel during inspiration, and the one-way valve on the inspiration channel is closed to close the inspiration channel during expiration. The mouthpiece may cooperate with a filter means for breath detection.

The mouthpiece can be designed into a mouth-type mouthpiece form or a mask form according to the actual use requirement. The buccal mouthpiece needs the testee to buccal mouthpiece, ensures that the mouth is tight and airtight, and carries out breath detection; for the mouth which can not be tightly held, the mouth can be held in a mask mode, and the mask is designed to be tightly attached to the mouth of the testee; for situations where nasal exhalation testing is desired, the mask may be designed to cover both the mouth and nose.

A partition board can be arranged in the mouthpiece, and the inspiration channel and the expiration channel are arranged on the partition board. In one aspect, a one-way valve mounting portion is provided on the partition.

The inhalation passage of the mouthpiece can be a section of cylindrical, rectangular or irregular shaped passage with a certain length, and can also be an opening. The suction channel of the mouthpiece is provided with at least one-way valve, and a vent hole is arranged below the one-way valve. When inhaling, the one-way valve is opened upwards, and the air can be inhaled into the human body through the vent hole; when the breathing device exhales, the one-way valve is tightly attached to the vent hole and is in a closed state, and exhaled air cannot enter the air suction channel of the device main body through the vent hole. The number of the check valves can be multiple, and preferably, the check valves are designed to be symmetrically arranged. The size of the vent hole is not too large, the pressure on the one-way valve during air suction can be improved through the arrangement of the vent hole, the opening of the one-way valve is guaranteed, and meanwhile the sealing performance of the one-way valve during air suction is guaranteed.

The exhalation passage of the mouthpiece can be a section of cylindrical, rectangular or irregularly shaped passage with a certain length, and can also be an opening. During inhalation, the exhalation passage can be closed by a one-way valve arranged on the device body or a valve arranged on the exhalation path of the detection instrument (for example, in some embodiments, a solenoid valve and a pressure sensor are arranged on the exhalation path of the detection instrument, the solenoid valve is normally closed, and is opened when the exhalation pressure is detected, gas sampling is started, and the sample collection time is sufficient, that is, the passage is closed, so that gas cannot enter the exhalation passage of the mouthpiece through the exhalation passage of the device body.

When inhaling, because the exhalation passageway of device main part is closed by check valve or solenoid valve, exhale the passageway and be the closed pipeline state, inhale and make exhale the passageway and be in a negative pressure state, but because inhale the passageway and open, the degree of negative pressure is not very high, so the gas in exhale the passageway is not easily sucked. For example, the exhalation passageway is a material which is not easy to deform, the internal space of the exhalation passageway is usually only a few tens of milliliters (for example, the maximum volume of the exhalation passageway in the embodiment is also only about 30mL), and the space which can be actually acted by negative pressure is only a few milliliters at least according to the arrangement position of the exhalation passageway opening and closing device (such as a one-way valve and a battery valve), so that only milliliter-level or even very little gas is sucked out of the passageway through the negative pressure. In a more preferred embodiment, a filter membrane is provided on the mouthpiece, and the filter membrane can filter out bacteria and the like in the gas even if minute gas is sucked out. The risk of cross-contamination is significantly reduced.

Preferably, the exhalation passage of the mouthpiece can be provided with a one-way valve, a vent hole is arranged above the one-way valve, the one-way valve is opened during exhalation, and the one-way valve is tightly attached to the vent hole to be in a closed state during inhalation. The size of the vent hole is not required to be too large, the pressure intensity of the one-way valve during expiration can be improved through the arrangement of the vent hole, the opening of the one-way valve is ensured, and meanwhile the sealing performance of the one-way valve during inspiration is also ensured.

When the testee inhales, dust and germs are not eliminated in the inhaled air, so that a filtering material, such as bacterial filtering cotton and high polymer material non-woven fabrics, can be arranged in the air suction channel of the mouthpiece. When a testee exhales, particles such as saliva, spray and food residues, even bacteria, viruses and the like are inevitably existed in the exhaled breath, so that a filtering material, such as bacteria filtering cotton, a high polymer material non-woven fabric, water absorption paper and the like or a combination of the materials can be arranged in the exhalation passage of the mouthpiece. The filter material may be separately provided in the inhalation passage and the exhalation passage of the mouthpiece, but preferably, the filter material may be uniformly provided above the inhalation passage and the exhalation passage of the mouthpiece, that is, at a position closer to the human body than the passages, in view of the process and cost. When in expiration, the gas passes through the filter material and then enters the expiration channel of the mouthpiece; during inhalation, the gas passes through the inhalation channel of the mouthpiece, then through the filter material and finally into the human body. Preferably, a layer of humidifying paper can be arranged below the filter material, and the humidifying paper can balance heat and water vapor in the exhaled air during exhalation. Because the mouthpiece is a single dedicated part, even if public areas for breathing out and breathing in exist at the filtering material and the humidifying paper of the preferred scheme, the problem of cross contamination does not exist. In one version, the filter material and the wetting paper are placed on a separator support.

The device main body is composed of a shell, and an expiration channel and an inspiration channel which are arranged in the shell and are independent of each other. The exhalation passage and the inhalation passage of the device main body respectively correspond to and are tightly matched with the exhalation passage and the inhalation passage of the mouthpiece, and air leakage cannot occur after combination. The matching connection part can be provided with various common methods for ensuring the air tightness of connection on the product structure design, such as a self-tightening interference fit mode, a gasket sealing mode, an O-shaped ring sealing mode, a thread sealing mode and the like.

The shell of the device main body is provided with an air inlet, and air enters the air suction channel from the air inlet during air suction. The upper end of the inspiration channel, namely the position closer to the mouthpiece, can be further provided with a one-way valve, and the one-way valve is opened during inspiration and closed during expiration to serve as a further barrier for preventing cross contamination. The inhalation channel is provided with a filter device, the channel design ensures that the airflow can not bypass the filter device to enter the downstream channel, the filter device can comprise a filter material for filtering substances to be detected in the inhalation gas, for example, for detecting exhalation nitric oxide (FeNO), the filter material can be potassium permanganate particles, activated carbon, molecular sieves and other substances or a mixture of the substances. The filtering device can be designed into a form that the bacteria filter cotton or the polymer non-woven fabric wraps the filtering material, so that the leakage of the filtering material is avoided.

The exhalation passage of the device main body can be provided with a one-way valve which is opened during exhalation and closed during inhalation. The one-way valve may be located anywhere in the exhalation passageway, but preferably the one-way valve is located at the front end of the exhalation passageway, i.e. near the junction with the mouthpiece exhalation passageway, to minimise the risk of inhalation of gases from the body of the device during inhalation. The exhalation passage can be provided with a filter material for filtering moisture, bacteria and small particulate matters in the exhaled air, and the filter material can be materials such as bacteria filter cotton, a drying agent, a molecular sieve and the like or a combination of the materials. The exhalation resistance can be adjusted by setting the porosity, length and other parameters of the filter material so as to meet the requirement of detection on the exhalation resistance. The tail end of the expiration channel is provided with a connecting device, and the device can be designed into a mode of being directly or indirectly connected with a detection instrument according to the requirements of actual use situations; for indirectly connected embodiments, the connecting means can be designed as a connection of a pipeline.

One of the objects of the present invention is also to provide a method of breath detection, comprising: providing a filter device comprising a mouthpiece and a device body, the mouthpiece being detachably attached to one end of the device body;

the device main body comprises a shell, an inspiration channel and an expiration channel which are arranged in the shell; the other end of the device main body comprises an air inlet which is in gas communication with an air suction channel of the device main body;

the mouthpiece comprises a shell, an inspiration channel and an expiration channel are arranged in the shell, a one-way valve is arranged on the inspiration channel, the one-way valve on the inspiration channel is opened to open the inspiration channel during inspiration, and the one-way valve on the inspiration channel is closed to close the inspiration channel during expiration;

after the mouthpiece is arranged at one end of the device main body, an expiration channel and an inspiration channel of the mouthpiece respectively correspond to and are combined with the expiration channel and the inspiration channel of the device main body in an airtight way;

the filter device also comprises an expiration channel opening and closing device, and when inhaling, the opening and closing device enables the expiration channel to be in a closed state;

providing a detection instrument communicable with the device body exhalation passage;

when a testee inhales, the one-way valve on the inhalation channel of the mouthpiece is opened, the opening and closing device on the exhalation channel is closed, and outside air enters from the air inlet of the device main body and enters the inhalation channel of the mouthpiece through the inhalation channel of the device main body, and finally is inhaled into the human body; when a testee exhales, the opening and closing device on the exhalation channel is opened, the one-way valve on the mouthpiece inhalation channel is closed, and exhaled gas enters the exhalation channel of the device main body through the exhalation channel of the mouthpiece and is conveyed to the detection instrument.

Preferably, the gas in the exhalation passage of the apparatus main body cannot enter the inhalation passage.

The mouthpiece in the filter device is used by a single person, can avoid the pollution of an air suction channel of a device body used by a plurality of persons so as to achieve the aim of preventing cross pollution in the expiration detection process, can be used for detecting the content of nitric oxide, carbon monoxide, expiration hydrogen or methane and the like in expiration, and is very suitable for clinical popularization and application.

At present, the breath detection instrument also has the design trend of small size and portability. The technical scheme of the invention can also be applied to the integrated design of the expiration filtering device and the detection instrument, and the form of the filtering device can have some deformation applications, such as that a part of the shell of the detection instrument is used as the shell of the filtering device, or the filtering device is arranged in the detection instrument. The spirit of the invention is similar and should be protected by the scope of the invention.

Drawings

Fig. 1 is a cross-sectional view of the breath detection filter device of example 1.

Fig. 2 is a cross-sectional view of the breath detection filter device according to embodiment 2.

Fig. 3 is a cross-sectional view of a mouthpiece of the exhalation detection filter apparatus of embodiment 3.

Fig. 4a is a cross-sectional view of a mouthpiece part of the exhalation detection filter apparatus according to embodiment 1 and embodiment.

Fig. 4b is a top view of the mouthpiece component one-way valve portion of the breath detection filter apparatus according to embodiments 1 and 1.

FIG. 4c is a schematic view showing the structure of the mouthpiece of embodiment 1 without the check valve in the inhalation passage.

Fig. 5 is a cross-sectional view of a mouthpiece of the exhalation detection filter apparatus of embodiment 4.

Fig. 6 is a schematic view of the mouthpiece and the device body after detachment.

Figure 7 is a schematic view of the mouthpiece and device body combination.

Fig. 8a is a schematic view showing the open state of the check valve in the inhalation passage when inhaling.

Fig. 8b is a schematic view showing the closed state of the check valve in the inhalation passage during exhalation.

Figure 9a is a schematic representation of the closed state of the one-way valve in the exhalation path during inhalation.

FIG. 9b is a schematic diagram showing the open state of the check valve in the exhalation passage during exhalation.

Detailed Description

Example 1

A cross-contamination resistant breath test filter device, as shown in fig. 1, 6 and 7, includes a mouthpiece 100 and a device body 200, to which the mouthpiece is detachably attached. For example, in one design, the mouthpiece 100 is replaceable, single person specific, and the device body 200 is usable by multiple persons.

The mouthpiece 100 is comprised of a housing 101, including an inhalation passage 110 and an exhalation passage 120 within the housing. A check valve 111 is disposed on the inhalation channel 110, and the check valve 111 may be designed as a film sheet, and is opened to open the inhalation channel when inhaling, and closed to close the inhalation channel when exhaling.

The mouthpiece 100 as shown in figures 1, 4a, 4b, 4c, 6 and 7 is in the form of a mask. The housing 101 comprises a mask 102 and an outer gas channel tube wall 103. The mask includes a vent 104 with an outer tube wall 103 enclosing an inspiratory channel 110 and an expiratory channel 120. The mask and the outer pipe wall of the gas passage are integrally formed or are assembled together in a gas-tight manner. The inhaled gas enters the human body through the inhalation passage and the mask air vent, and the exhaled gas enters the exhalation passage through the mask air vent.

As shown in fig. 4a, 4b and 4c, the mouthpiece 100 of the present embodiment has an inhalation channel 110 and an exhalation channel 120, a partition 105 is disposed in the outer wall of the gas channel, one end of the partition is connected to the outer wall, and the other end is connected to the wall of the exhalation channel 120. In the embodiment, the exhalation passage is arranged in the middle of the mouthpiece, the cavity between the tube wall of the exhalation passage and the outer tube wall of the gas passage forms an inhalation passage 110, and a one-way valve 111 is arranged above the inhalation passage. As shown in fig. 8a, when inhaling, the one-way valve on the inhalation passage is opened to open the inhalation passage, and the inhaled gas enters the subject through the inhalation passage. As shown in fig. 8b, when the patient exhales, the check valve is closed to close the inhalation passage, and the gas exhaled by the patient cannot enter the inhalation passage through the check valve of the inhalation passage.

In this embodiment, the partition plate 105 is provided with a vent hole 112 of the suction passage, and the vent hole 112 is located above the suction path of the check valve 111 of the suction passage 110. The air vent is arranged, so that the pressure of air in the air suction channel to the one-way valve during air suction can be improved, and the opening of the one-way valve is guaranteed. The size of the vent hole is not too large so as not to affect the sealing performance when the one-way valve is closed. For example, the vent hole is smaller in size than the one-way valve diaphragm, which can completely cover the vent hole when the one-way valve is closed.

The partition plate is provided with a mounting insertion hole 114 of the check valve 111, a pin 113 of the check valve is inserted into the insertion hole 114, a diaphragm of the check valve 111 covers the suction passage, and the diaphragm of the check valve 111 covers the vent hole 112 in this embodiment. The plug 113 of the one-way valve is inserted into the partition board to be provided with the insertion hole 114, the plug 113 is in interference fit with the insertion hole 114, and the plug is ensured to be inserted into the insertion hole to form air-tight connection through compression deformation of the material of the one-way valve.

A filter material 131 is provided above the inhalation and

exhalation passages

110, 120, for example between the inhalation and exhalation passages and the mouthpiece vent. The filter material is mounted on a baffle bracket of the mouthpiece and is positioned above the inspiratory airway and/or the airway. In a preferred embodiment, the filter material 131 is mounted on a filter material support 106 that is attached to the baffle at one end and supports the filter material at the other end. Certain distance is arranged between the filtering material and the membrane of the one-way valve so as to provide a space for opening and closing the one-way valve and ensure the smoothness of air flow. The filter material can be bacterial filter cotton, non-woven fabrics of high molecular materials, absorbent paper and the like or a combination of the materials, and is used for filtering saliva, food residues, droplets, moisture, bacteria, viruses and the like in the breath and filtering possible dust and bacteria in the inhaled air.

In one design, a partition is arranged in the mouthpiece, and the partition comprises an expiration channel with a certain length and an inspiration channel opening arranged on the partition. The expiration channel is arranged at the central position of the partition plate, and an inspiration channel is formed between the tube wall of the expiration channel and the inner wall of the shell of the mouthpiece. The baffle is detachably placed in the mouthpiece or integrally formed with the mouthpiece.

The device body 200 includes a housing 201, and an inhalation passage 210 and an exhalation passage 220 provided in the housing, and a gas in the exhalation passage cannot enter the inhalation passage, for example, the exhalation passage and the inhalation passage are independent from each other. When the mouthpiece is assembled to the device body, the exhalation passageways 120 and the inhalation passageways 110 of the mouthpiece 100 and the exhalation passageways 220 and the inhalation passageways 210 of the device body 200 correspond to each other and are airtightly joined to each other, which means that the joint of the two exhalation passageways or the joint of the two inhalation passageways does not leak air after being combined. An air inlet 219 is provided in the housing of the device body 200, and air enters the inhalation passage 210 from the air inlet 219 when inhaling. The end of the exhalation passageway 220 (i.e., the end remote from the mouthpiece) is provided with a connection 229 which can be connected directly to the test instrument or through the air tube 300 to the test instrument to connect the exhalation test filter assembly to the test instrument.

As shown in fig. 1 and 2, an inhalation channel 210 and an exhalation channel 220 are provided in the device body 200, and a partition 205 is provided in the housing, which can be mounted later and connected with the inner wall of the housing and the wall of the exhalation channel 220 by a buckle. In the present embodiment, an exhalation passage is provided in the middle of the apparatus main body, and a cavity between the tube wall of the exhalation passage and the inner wall of the housing forms an inhalation passage 110.

At the upper end of the inhalation passage 210 illustrated in fig. 1, i.e., the end away from the air inlet 219, a check valve 211 is provided, which is open when inhaling and closed when exhaling. The one-way valve can further avoid cross contamination prevention in breath detection. Meanwhile, the mouthpiece in the prior art (for example, the mouthpiece is not provided with an inhalation channel and an exhalation channel) can be used by a testee under the condition that the risk of cross contamination is not high (for example, the device is used by a special person or different persons are clearly healthy people), and the mouthpiece is matched with the device main body to reduce the use cost. In one embodiment, the partition is provided with a mounting socket for a check valve, a pin of the check valve is inserted into the socket, and a diaphragm of the check valve covers the suction passage. The plug pins are in interference fit with the jacks, and the plug pins are ensured to be inserted into the jacks to form airtight connection through compression deformation of the material of the one-way valve.

The suction channel 210 has a first chamber for holding the filter 215, which is disposed between two partitions of the suction channel, so that the air flow does not bypass the filter 215 and enter a downstream channel (e.g., a mouthpiece suction channel). The filter material can be placed on the partition board in the shell. The filter 215 may include a filter material for filtering a substance to be detected in the inhaled gas, for example, for detecting exhaled nitric oxide (FeNO), the filter material may be potassium permanganate particles, activated carbon, molecular sieves, or a mixture thereof. The filtering material 215 can be made of bacteria filtering cotton or polymer non-woven cloth to wrap the filtering material, so as to avoid leakage of the filtering material. If desired, a second chamber 216 for holding filter media may also be provided in the suction channel 210, the two chambers being arranged in series on the suction channel. In this example, the filter is disposed below the one-way valve, i.e., upstream of the one-way valve in the suction path.

One end of the exhalation passageway 220 near the mouthpiece 100 is provided with a one-way valve 221, which is opened during exhalation and closed during inhalation to ensure that the gas in the exhalation passageway 220 in the device body 200 is not inhaled into the human body during inhalation.

A filter material 225 is arranged in the exhalation passage 220, and the filter material can be a material such as bacteria filter cotton, a desiccant, a molecular sieve, or a combination of these materials, and is used for further filtering moisture, bacteria and small particulate matters in the exhaled air, so as to prevent the exhaled air from polluting the detection instrument and generate condensed water in the gas path of the detection instrument. The filter material can be placed on the support frame in the expiration passageway.

The filter material in the expiration detection filter device basically cannot move in the shell during expiration test.

As shown in fig. 1 and 7, the head end of the device body (i.e., the end combined with the mouthpiece) is provided with a mounting socket 202, and the outer tube wall 103 or prongs of the gas passage of the mouthpiece are inserted into the socket 202, thereby connecting the mouthpiece and the device body together. The air suction channel on the mouthpiece is communicated with the air suction channel on the device main body through an air passage. In this embodiment, the exhalation passage of the apparatus main body is inserted into the exhalation passage of the mouthpiece, and the connection of the two exhalation passages is realized. In this example, the exhalation passageways on the mouthpiece and the exhalation passageways on the device body are connected to each other by an interference fit therebetween, and airtightness therebetween is ensured.

Based on the above embodiment, when the first subject inhales, air enters from the air inlet 219 of the device body 200, passes through the filter material and the check valve 211 in the device body inhalation passage 210 in sequence, then enters the inhalation passage 110 of the mouthpiece 100, passes through the check valve 111 on the inhalation passage 110 in sequence, and the filter material 131 on the mouthpiece in sequence, and finally is inhaled into the human body. When a testee exhales, the exhaled gas enters the exhalation passage 220 of the device body through the filter material 131 on the mouthpiece and the exhalation passage 120 on the mouthpiece in sequence, then reaches the connecting device 229 through the one-way valve 221 and the filter material 225 on the exhalation passage of the device body in sequence, and the exhaled gas sample is conveyed to the detection instrument through the air pipe 300. Inspiratory and expiratory airflow progression referring to fig. 1, the solid line arrow illustrates the inspiratory airflow progression and the dashed line arrow illustrates the expiratory airflow progression.

After the first subject completes the breath test, the mouthpiece is removed from the device body. When a second subject needs breath test, a new mouthpiece is attached to the device body. When the second person to be tested inhales, the external air enters the human body through the inhaling passage. Because the device main body exhales and is provided with the check valve on the passageway, especially the check valve of device main body exhales the passageway and sets up the opening part at exhaling the passageway, when the second person of examinee breathes in, even if the device main body exhales in the passageway and remains the exhale residual of first person of examinee, these residual can not get into the person of examinee through the exhale passageway of mouthpiece.

If the one-way valve of the exhalation passage of the device body is not arranged at the opening of the exhalation passage of the device body, but is arranged at a position slightly lower than the opening, a small section of passage which cannot be closed by the one-way valve is reserved between the one-way valve and the opening. Because the passage is at the junction of the device body and the mouthpiece, the sterilising agent is relatively easily accessible and can be thoroughly sterilised and cleaned. Therefore, when the first testee finishes breath detection, the medical staff only needs to disinfect the small breath passage by using the disinfection reagent, and the cleaning and disinfection work of the device main body can be finished, thereby avoiding the condition of cross contamination. And because the exhalation passage of the device main body is closed by the one-way valve, the exhalation passage of the mouthpiece is in a negative pressure state during inhalation, so that the gas in the passage is not easy to be sucked out or only a small amount of gas can be sucked out. This greatly reduces the risk of cross-contamination.

Example 2

This embodiment is shown in figure 2. Embodiment 2 is the same as embodiment 1 in the mouthpiece design of embodiment 2, and the main difference is that the inhalation passage 210 of the device main body 200 of embodiment 2 is not provided with the check valve 211. Because the one-way valve 111 is arranged on the inspiration channel 110 of the mouthpiece 100, when the user exhales, the one-way valve 111 on the mouthpiece is closed, and the exhaled air can not enter the inspiration channel of the mouthpiece, so that the exhaled air can not enter the inspiration channel 210 of the device main body 200, the phenomenon that the exhaled air pollutes the inspiration channel of the device main body is avoided, and the actual effect of preventing cross contamination of the invention is achieved.

Example 3

As a mouthpiece shown in fig. 3, embodiment 3 can be applied to the device main body 200 of embodiment 1 or embodiment 2. In the mouthpiece design of this embodiment, a one-way valve 121 is added to the mouthpiece in the exhalation passageways 120. In a preferred aspect, a vent 122 is provided above the expiratory path check valve. The one-

way valves

121 and 111 are arranged on the exhalation passage 120 and the inhalation passage 110 of the mouthpiece, so that the exhalation gas is further ensured not to pollute the inhalation passage of the device main body, the gas is ensured not to be inhaled from the path of the exhalation passage during inhalation, and the risk of cross contamination is completely avoided. The mouthpiece can be applied in devices for breath and inspiration detection.

As shown in fig. 9a, when inhaling, the one-way valve on the exhalation passage is closed to close the exhalation passage, and the gas in the exhalation passage cannot enter the subject. As shown in fig. 9b, during exhalation, the one-way valve is opened to open the exhalation passage, and the gas exhaled by the subject enters the exhalation passage through the one-way valve of the exhalation passage.

Example 4

As shown in the mouthpiece of fig. 5, a layer of humidifying paper 132 is added below the filtering material 131 of the mouthpiece 100, and the humidifying paper can balance the heat and moisture of the exhaled air, so as to prevent the exhaled air from entering the exhalation passageways 220 of the device main body 200, accelerate the loss of the filtering material 225, or generate condensed water in the exhalation passageways 200 of the device main body or even in the detection instrument. The mouthpiece of this embodiment can be used in combination with the device main body described in embodiment 1 or embodiment 2.

Under the condition that after the device main body and the mouthpiece are assembled together, the expiration channel and the inspiration channel of the device main body respectively correspond to the expiration channel and the inspiration channel of the mouthpiece and are in air-tight fit with each other. The arrangement mode of the inspiration channel and the expiration channel in the mouthpiece or the device body can be designed at will according to the needs. For example, an exhalation path is provided in the middle of the mouthpiece or the device body, and an inhalation path surrounds the outer periphery of the exhalation path. For another example, the inhalation channel and the exhalation channel are provided in two separate areas of the mouthpiece or the device body, for example, the inhalation channel and the exhalation channel are arranged side by side in the left-right direction.

The exhalation passageways in the mouthpiece and the device body may be one or more, and the inhalation passageways in the mouthpiece and the device body may be one or more.

The exhalation passage and the inhalation passage of the mouthpiece can be cylindrical, rectangular or irregularly shaped passages with a certain length, and can also be an opening or a vent hole.

According to empirical analysis, the filter device disclosed by the invention has good performance of preventing cross infection in breath detection.

Claims

1. The filtering device for breath detection comprises a device main body, wherein the device main body comprises a shell, an inspiration channel and an expiration channel which are arranged in the shell, and gas in the expiration channel cannot enter the inspiration channel; one end of the device main body comprises an air inlet which is in gas communication with an air suction channel of the device main body; the device is characterized in that a mouthpiece is detachably arranged at the other end of the device main body, the mouthpiece comprises a shell, an air suction channel and an air expiration channel are arranged in the shell, and after the device is arranged, the air expiration channel and the air suction channel of the mouthpiece respectively correspond to the air expiration channel and the air suction channel of the device main body and are combined in an air-tight manner; the inhalation passage of the mouthpiece is provided with a one-way valve, when inhaling, the one-way valve on the inhalation passage is opened to open the inhalation passage, and when exhaling, the one-way valve on the inhalation passage is closed to close the inhalation passage; the breathing device also comprises an exhalation channel opening and closing device, wherein when breathing, the opening and closing device is closed, and the exhalation channel is in a closed state.

2. The filtering device according to claim 1, wherein the opening and closing device of the exhalation passage is selected from one or a combination of a one-way valve on the exhalation passage of the device body, a one-way valve on the mouthpiece exhalation passage, and a solenoid valve on a detection instrument communicated with the filtering device; when the patient exhales, the one-way valve is opened and/or the electromagnetic valve is opened to open the exhalation passage; on inhalation, the one-way valve closes and/or the solenoid valve closes to close the breathing passage.

3. A filter device according to any one of claims 1 to 3, wherein the airtight connection is selected from the group consisting of a self-tightening interference fit, a gasket seal, an O-ring seal, and a screw seal.

4. A filter device according to any one of claims 1 to 3, wherein the suction passage in the device body comprises a filter material.

5. The mouthpiece comprises a shell and is characterized in that an inspiration channel and an expiration channel are arranged in the shell, a one-way valve is arranged on the inspiration channel, the one-way valve on the inspiration channel is opened to open the inspiration channel during inspiration, and the one-way valve on the inspiration channel is closed to close the inspiration channel during expiration.

6. The mouthpiece of claim 5, wherein the exhalation passage of the mouthpiece is provided with a one-way valve, and when exhaling, the one-way valve on the exhalation passage is opened to open the exhalation passage, and when inhaling, the one-way valve on the exhalation passage is closed to close the breathing passage.

7. A mouthpiece as claimed in any of claims 5 to 6, in which a layer of filter material is provided within the mouthpiece.

8. A method of breath detection, comprising:

providing a filter device comprising a mouthpiece and a device body, the mouthpiece being detachably attached to one end of the device body;

the device main body comprises a shell, an inspiration channel and an expiration channel which are arranged in the shell, and gas in the expiration channel cannot enter the inspiration channel; the other end of the device main body comprises an air inlet which is in gas communication with an air suction channel of the device main body;

9. The method according to claim 8, wherein the open-close device on the exhalation passage is selected from one or a combination of a one-way valve on the exhalation passage of the main body of the device, a one-way valve on the exhalation passage of the mouthpiece, and a solenoid valve on the detection instrument communicated with the filtering device; when the patient exhales, the one-way valve is opened and/or the electromagnetic valve is opened to open the exhalation passage; on inhalation, the one-way valve closes and/or the solenoid valve closes to close the breathing passage.

10. Method according to one of claims 8 to 9, for detecting the nitric oxide, carbon monoxide, exhaled hydrogen or methane content in exhaled breath.