Exhaled breath component sampling device and method for analyzing exhaled breath components using the same

Abstract

The present invention provides a breath component collection device and breath component analysis method that prevent deterioration, alteration, concentration reduction, and contamination of breath samples, while also reducing the burden on subjects required for sample collection and enabling highly accurate breath analysis. [Solution] The device comprises a mask portion that is worn on the face so as to cover the mouth and nose of the subject and forms a sealed space inside when worn, a collection member that is positioned outside the mask portion and filled with a collecting agent for collecting exhaled breath components, and a connecting portion that connects the mask portion and the collection member so as to be able to communicate. The connecting portion is provided with a flow path switching mechanism that switches between a flow path that discharges at least the gas inside the mask portion to the outside of the device before exhaled breath component collection and a flow path that introduces the subject's exhaled breath into the collection member when exhaled breath component collection is performed. The connecting portion has an outlet for discharging the gas that has passed through the collection member, and a first check valve is provided at the outlet of this connecting portion to restrict the introduction of ambient air into the collection member.

Description

Technical Field

[0001] The present invention mainly relates to an exhaled gas component collection device used when collecting an exhaled gas sample of a subject in breath analysis for diagnosing and evaluating the disease, pathological condition, health status, etc. of the subject, and a method for analyzing the exhaled gas components collected using the same.

Background Art

[0002] Exhaled breath contains various volatile organic compounds (VOCs) and volatile inorganic compounds (VICs) produced by metabolism. It is known that these exhaled gas components are related to specific diseases, pathological conditions, and health status. Therefore, in order to clinically diagnose diseases and pathological conditions and evaluate health status, etc., analysis of exhaled gas components is carried out. For example, looking at NO (nitric oxide), the NO concentration in the exhaled breath of healthy people is about several ppb to 25 ppb, while during exacerbation of bronchial asthma, the NO concentration in the exhaled breath increases to about several hundred ppb, so it is used as a control index for bronchial asthma treatment. Also, in so-called breath alcohol tests, the drinking state of the subject is determined by measuring the alcohol concentration in the exhaled breath (see Non-Patent Document 1 in both cases).

[0003] Since the diagnosis by such breath analysis is a non-invasive diagnosis with less burden on the subject, many studies are being promoted to find new associations between exhaled gas components and diseases / pathological conditions in order to increase the number of diseases and pathological conditions that can be diagnosed by breath analysis. For example, Patent Document 1 discloses using a combination of multiple exhaled gas components as a lung cancer marker, and it is described that the exhaled breath of lung cancer patients and normal subjects was collected in an analytic barrier bag, and the components contained in the exhaled breath were measured by gas chromatography-mass spectrometry.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Patent Document 2

[0005] [Non-Patent Document 1] Akihito Shimonai, Takaharu Kondo, "Current Status, Challenges, and Future Prospects of Exhaled Breath Diagnostic Technology," Applied Physics, 2014, Vol. 83, No. 1, pp. 26-32. [Overview of the project] [Problems that the invention aims to solve]

[0006] In breath analysis, the object of analysis is a gaseous sample of "exhaled breath," and the concentration of specific components targeted for diagnosis and evaluation in the breath sample is extremely low, around ppb. Therefore, in order to improve the accuracy of breath analysis, it is necessary to prevent deterioration, changes, concentration decreases, and contamination by ambient air in the breath components collected from the subject. For this reason, when the subject's exhaled breath is collected as a gas in a sample bag, as in the measurement method disclosed in Patent Document 1, it is necessary to perform the analysis immediately to prevent deterioration of the breath sample. However, it is not practical to perform instrumental analysis using gas chromatography, etc., every time a breath sample is collected, so it is common to analyze a certain amount of samples collected over a predetermined period all at once.

[0007] Therefore, in order to prevent deterioration, changes, concentration decreases, and contamination of breath samples collected from subjects, Patent Document 2 describes a device that uses an sorbent tube 20 filled with an sorbent for collecting breath components instead of a sample bag, and collects breath samples by adsorbing breath components in the breath onto this sorbent. The breath components collected in the sorbent tube are less likely to deteriorate and can be stored stably. However, the breath component collection device disclosed in Patent Document 2 consists of a face mask 30 that covers the subject's mouth and nose, an sorbent tube 20 filled with an sorbent, and a pump 28 that pumps exhaled breath into the sorbent tube 20. Because a pump 28 with a certain level of suction capacity is required to pump exhaled breath into the sorbent tube 20, the device itself becomes heavy, which is a problem. Therefore, when subjects collect breath samples, they are required to hold a heavy device with both hands and exhale while placing their face against the face mask portion of the device. This requires them to maintain their posture with their hands occupied, which can be time-consuming or burdensome for subjects with limited physical strength.

[0008] Therefore, the present invention has been made in view of the above-mentioned points, and its purpose is to provide a breath component collection device and a breath component analysis method using the same, which improve the accuracy of breath analysis by preventing deterioration, changes, decrease in concentration, contamination due to the mixing of ambient air, etc. of collected breath samples, and reduce the burden on subjects required for breath sample collection, enabling easy and highly accurate breath analysis. [Means for solving the problem]

[0009] To solve the above problems, the present invention provides a breath component collection device for collecting breath components contained in the breath of a subject, comprising: a mask portion that is attached to the face so as to cover the mouth and nose of the subject and forms a sealed space inside when attached; a collection member that is arranged outside the mask portion and filled with a collecting agent for collecting breath components; and a connecting portion that connects the mask portion and the collection member so as to be able to communicate. The connecting portion is provided with a flow path switching mechanism that switches between a flow path that discharges at least the gas inside the mask portion to the outside of the device before breath component collection and a flow path that introduces the subject's breath into the collection member when breath component collection is performed. The connecting portion has an outlet for discharging the gas that has passed through the collection member, and the outlet of the connecting portion is provided with a first check valve that restricts the introduction of ambient air into the collection member.

[0010] The exhaled breath component collection device of the present invention comprises a mask portion that is worn on the face so as to cover the mouth and nose of a subject and forms a sealed space inside when worn, a collection member that is positioned outside the mask portion and filled with a collecting agent for collecting exhaled breath components, and a connecting portion that connects the mask portion and the collection member so as to be able to communicate. When a subject blows exhaled breath while wearing the mask portion, the exhaled breath is introduced from the mask portion through the connecting portion into the collection member, so that the exhaled breath components contained in the exhaled breath are collected by the collecting agent, and the exhaled breath components are kept in a state that is less likely to deteriorate or change, and are collected stably. Furthermore, the connecting portion is provided with an outlet through which the gas that has passed through the collection member is discharged, so that the exhaled breath blown in by the subject is discharged outside the device after passing through the collecting agent in the collection member, so that exhaled breath does not accumulate inside the device and the pressure inside the device does not increase, and the subject can continuously blow exhaled with a constant blowing force. As described above, the exhaled breath component collection device of the present invention is a compact mask-type device in which a collection member is connected to the outside of the mask portion worn by the subject. Therefore, the device itself is lightweight, and the subject's hands are not occupied when collecting exhaled breath. The subject only needs to wear the mask portion like a sanitary mask and blow exhaled with a constant force, thus reducing the burden on the subject when collecting exhaled breath samples. Furthermore, in the device of the present invention, a first check valve is provided at the outlet of the connection portion to restrict the introduction of ambient air into the collection member, thereby preventing ambient air from mixing into the collection member and preventing components other than the subject's exhaled breath from being adsorbed by the collecting agent. Moreover, the connection portion of the present invention is provided with a flow path switching mechanism that switches between a flow path that discharges at least the gas inside the mask portion to the outside of the device before exhaled breath component collection and a flow path that introduces the subject's exhaled breath into the collection member when exhaled breath component collection occurs. Therefore, gas that was originally present in the inner space of the mask portion and the dead space of the connection portion can be discharged to the outside of the device without being introduced into the collection member. These mechanisms allow for the introduction of only the subject's exhaled breath into the collection component as much as possible, and the adsorption of the subject's exhaled breath components onto the collection agent, thereby improving the accuracy of breath analysis.

[0011] Furthermore, it is preferable that the connection portion of the exhaled breath component collection device of the present invention is provided with a second check valve that restricts the introduction of gas into the mask portion. This prevents ambient air from mixing in from the exhaust channel and being introduced into the mask portion when the flow path switching mechanism provided in the connection portion switches the gas flow path of the connection portion to a flow path that discharges the gas inside the mask portion to the outside of the device. It also prevents air that was originally present in the dead space of the connection portion from being introduced into the mask portion. Therefore, as much as possible, only the subject's exhaled breath can be introduced into the collection member and the subject's exhaled breath components can be adsorbed onto the collection agent, thereby improving the accuracy of exhaled breath analysis.

[0012] Furthermore, it is preferable that the flow path, which is switched by the flow path switching mechanism of the exhaled breath component collection device of the present invention, and which discharges at least the gas inside the mask to the outside of the device before exhaled breath component collection, is provided with a third check valve that restricts the introduction of ambient air into this flow path. This prevents ambient air from mixing in from the discharge flow path and being introduced into the connection part, so that as much as possible only the subject's exhaled breath is introduced into the collection member and the subject's exhaled breath components are adsorbed onto the collection agent, thereby further improving the accuracy of exhaled breath analysis.

[0013] Furthermore, it is preferable that the flow path switching mechanism of the exhaled breath component collection device of the present invention comprises a guide member and two plate-shaped members arranged to slide freely inside and outside the guide member, the guide member being provided with a gas discharge channel hole and an exhaled breath inlet, and the two plate-shaped members being provided with a gas discharge channel groove and an exhaled breath inlet, respectively, and that by sliding the two plate-shaped members, (i) the gas discharge channel hole of the guide member and the gas discharge channel groove of the plate-shaped members communicate, thereby switching to a flow path that discharges at least the gas inside the mask to the outside of the device, and (ii) the exhaled breath inlet of the guide member and the exhaled breath inlet of the plate-shaped members communicate, thereby switching to a flow path that introduces the subject's exhaled breath into the collection member. By configuring the flow path switching mechanism in this way, the gas flow path can be switched simply by sliding the two plate-shaped members, making the switching operation easy for the subject, and a suitable structure for a flow path switching mechanism is selected.

[0014] Furthermore, it is preferable that the flow path switching mechanism of the exhaled breath component collection device of the present invention comprises a guide member and a plate-shaped member slidably positioned inside and outside the guide member, wherein the guide member is provided with a gas discharge flow path hole and an exhaled breath inlet, and the plate-shaped member is provided with an exhaled breath inlet, and by sliding the plate-shaped member, (i) the exhaled breath inlet of the guide member is shielded by the wall surface of the plate-shaped member while the gas discharge flow path hole of the guide member is exposed, thereby switching to a flow path that discharges at least the gas inside the mask to the outside of the device, and (ii) the gas discharge flow path hole of the guide member is shielded by the wall surface of the plate-shaped member while the exhaled breath inlet of the guide member and the exhaled breath inlet hole of the plate-shaped member communicate, thereby switching to a flow path that introduces the subject's exhaled breath into the collection member. By configuring the flow path switching mechanism in this way, the gas flow path can be switched simply by sliding a single plate-shaped member, making the switching operation easy for the subject, and a suitable structure for a flow path switching mechanism is selected.

[0015] Furthermore, it is preferable that the connection section of the exhaled breath component collection device of the present invention is equipped with a tubular member that branches in three directions, and the flow path switching mechanism is equipped with a switching valve at the branching point of the tubular member that switches between a flow path that discharges at least the gas inside the mask to the outside of the device and a flow path that introduces the subject's exhaled breath into the collection member. By configuring the connection section and the flow path switching mechanism in this way, the gas flow path can be switched by operating only the switching valve, making the switching operation easy for the subject, and a suitable structure for the flow path switching mechanism is selected.

[0016] Furthermore, it is preferable that the mask portion of the exhaled breath component collection device of the present invention is provided with an air intake port, and that a filter for purifying ambient air is placed in this air intake port. This allows clean air to be introduced into the mask portion, so that even when a large amount of exhaled breath sample from a subject is required, a sufficient amount of exhaled breath can be blown into the collection member and exhaled breath components can be collected.

[0017] Furthermore, the present invention provides a method for analyzing exhaled breath components using the exhaled breath component collection device described above, comprising the steps of: switching the flow path switching mechanism of the exhaled breath component collection device to a flow path that discharges at least the gas inside the mask to the outside of the device, thereby discharging at least the gas inside the mask to the outside of the device before exhaled breath component collection; switching the flow path switching mechanism of the exhaled breath component collection device to a flow path that introduces the subject's exhaled breath into a collection member, introducing the subject's exhaled breath into the collection member, and collecting the exhaled breath components by adsorbing them onto the collecting agent of the collection member; and heating the collecting agent of the collection member from which the subject's exhaled breath components have been collected, and measuring the desorbed gas. According to the analysis method of the present invention, using the exhaled breath component collection device described above, before exhaled breath component collection, the flow path switching mechanism in the device is switched to a flow path that discharges at least the gas inside the mask to the outside of the device, thereby discharging gas that was originally present in the inner space of the mask and the dead space of the connection to the outside of the device, so as not to introduce it into the collection member. Subsequently, when collecting exhaled breath components, the device's flow path switching mechanism switches to a flow path that introduces the subject's exhaled breath into the collection member, allowing the exhaled breath components to be adsorbed onto the collecting agent of the collection member and collected. Since the collected exhaled breath components are adsorbed and collected onto the collecting agent, they are less likely to deteriorate or change and are stably maintained. Then, when preparations for analysis are complete, the collecting agent of the collection member in which the exhaled breath components have been collected is heated, and the exhaled breath components are analyzed by measuring the desorbed gas. In this way, the exhaled breath component analysis method of the present invention allows for easy and highly accurate exhaled breath analysis. [Effects of the Invention]

[0018] According to the present invention, it is possible to provide a breath component sampling device and a breath component analysis method using this device that have the following excellent effects. (1) Because it is a compact mask-type device, the device itself is lightweight and easy to handle. Since breath components can be collected by wearing the mask and blowing in with a constant force, the burden on the subject can be reduced. (2) Due to the flow path switching mechanism and check valve provided in the device, the collector for collecting exhaled components is configured to collect only the exhaled components of the subject as much as possible and not to collect the components contained in the ambient air or dead space as much as possible. Therefore, the accuracy of exhaled breath analysis can be improved. (3) Since the exhaled components are collected by the collector for collection, deterioration and changes of the exhaled components are unlikely to occur, and highly accurate exhaled breath analysis can be performed.

Brief Description of the Drawings

[0019] [Figure 1] Figs. (a) exploded perspective view seen from the front side and (b) exploded perspective view seen from the back side of the exhaled component collection device according to the first embodiment. [Figure 2] Figs. (a) perspective view, (b) side sectional view, and (c) sectional view taken along line I-I of Fig. 2(a) showing the state before exhaled component collection of the exhaled component collection device according to the first embodiment. [Figure 3] Figs. (a) perspective view, (b) side sectional view, and (c) sectional view taken along line I-I of Fig. 3(a) showing the state during exhaled component collection of the exhaled component collection device according to the first embodiment. [Figure 4] Figs. (a) exploded perspective view seen from the front side and (b) exploded perspective view seen from the back side of the exhaled component collection device according to the second embodiment. [Figure 5] Figs. (a) perspective view and (b) side sectional view showing the state before exhaled component collection of the exhaled component collection device according to the second embodiment. [Figure 6] Figs. (a) perspective view and (b) side sectional view showing the state during exhaled component collection of the exhaled component collection device according to the second embodiment. [Figure 7] Exploded perspective view of the exhaled component collection device according to the third embodiment. [Figure 8] Figs. (a) perspective view and (b) side sectional view showing the state before exhaled component collection of the exhaled component collection device according to the third embodiment. [Figure 9] Figs. (a) perspective view and (b) side sectional view showing the state during exhaled component collection of the exhaled component collection device according to the third embodiment. [Modes for carrying out the invention]

[0020] Hereinafter, with reference to Figures 1 to 3, a breath component sampling device 1 according to the first embodiment of the present invention and a breath component analysis method using this device will be described in detail. As shown in Figure 1, the breath component sampling device 1 according to this embodiment is generally composed of a mask part 2 that is worn on the face so as to cover the mouth and nose of a subject, a collection member 6 that collects breath components, a connecting part 3 that connects the mask part 2 and the collection member 6 so as to be able to communicate, a flow path switching mechanism 5 that switches between a flow path that discharges the gas inside the mask part 2 to the outside of the device 1 and a flow path that introduces the subject's breath into the collection member 6, and a first check valve 7 that restricts the introduction of ambient air into the collection member 6 from a gas outlet 37. As shown in Figures 1 to 3, the flow path switching mechanism 5 of the breath component sampling device 1 according to this embodiment is generally composed of a guide member 51 and two plate-shaped members 54 that are slidably arranged inside and outside the guide member 51. In this specification, "up and down" refers to the vertical direction when the breath sample collection device is worn and used by a subject, i.e., the vertical direction in Figures 2(a) and 3(a), etc. In this specification, "left and right direction" refers to the left and right direction when the breath sample collection device is in use, i.e., the lateral (left and right) direction in Figures 2(a) and 3(a), etc. In this specification, the upstream side and downstream side of the gas flow path refer to the side of the mask portion of the breath sample collection device that is closer to the inlet, and the opposite side, as the upstream side and downstream side, respectively.

[0021] First, the mask portion 2 that constitutes the exhaled breath component collection device 1 will be described. The mask portion 2 is worn on the face so as to cover the subject's mouth and nose, and is configured to form a sealed space inside when worn. As shown in Figures 1 to 3, the mask portion 2 has a facepiece 21 that covers the subject's mouth and nose, and a fastening string 26 for securing the facepiece 21 to the face. The facepiece 21 is made of a plastic material such as polycarbonate, which has the rigidity to maintain a predetermined shape and is lightweight. In addition, the peripheral edge 23 of the facepiece 21 is made of a flexible material such as silicone rubber, at least in the inner portion that contacts the face, to improve wearability and to form a sealed space inside the facepiece 21 when it is in close contact with the face. The facepiece 21 is provided with an inlet 22 at a position facing the subject's mouth when worn, and the subject's exhaled breath is introduced into the collection member 6 through this inlet 22 via a connecting portion 3, which will be described later. Furthermore, in this embodiment, the facepiece 21 is provided with one air intake port 24 on each side, and an air purification filter 25 is fitted into the air intake port 24 to purify the ambient air and bring clean air into the mask portion 2. As a result, particulate matter and other components present in the ambient air are captured by the filter 25, and clean air is introduced into the facepiece 21 from the air intake port 24. This allows a sufficient amount of exhaled breath to be introduced into the collection member 6 and exhaled breath components to be collected, even when a large amount of exhaled breath sample from the subject is required.

[0022] Next, the connection part 3 will be described. The connection part 3 is configured to connect the mask part 2, described above, and the collection member 6, described later, so that they can communicate with each other. For this reason, the connection part 3 is configured to have a gas flow path that communicates from the inlet 22 of the mask part 2 to the exhaled air introduction part 62 of the collection member 6. As shown in Figures 1 to 3, the connection part 3 according to this embodiment includes an inlet side member 31, a flow path switching mechanism 5, a collection member side member 33, and a collection member housing lid 36, arranged from the upstream side to the downstream side of the gas flow path. First, the inlet side member 31 according to this embodiment is formed from a circular pipe with both ends open and a horizontally elongated rectangular thin box body that opens toward the downstream side of the gas flow path. One end of this circular pipe is connected to the inlet 22 of the mask part 2, and the other end is connected so as to penetrate the bottom surface of the thin box body, and the bottom surface of the box body at the connection part is provided with a flow path opening 32 which becomes a gas flow path.

[0023] In this embodiment, a second check valve 4 is provided downstream of the flow path opening 2 of the blowing port side member 31 that constitutes the connection part 3. This check valve 4 allows the introduction of gas from inside the mask part 2 to the connection part 3, but restricts the introduction of gas from the connection part 3 to inside the mask part 2. The second check valve 4 consists of a membrane-like member 42 and a mounting pin 41 that locks it so that it can move back and forth. The membrane-like member 42 is formed from an inert rubber material such as a thin film of silicone rubber. The membrane-like member 42 of the second check valve 4 is locked by the mounting pin 41, which has a shaft portion of a predetermined length, in a position that covers the flow path opening 32 of the blowing port side member 31 from the downstream side. Therefore, when exhaled air is blown from inside the mask part 2 to the connection part 3, the membrane-like member 42 moves downstream of the gas flow path along the shaft portion of the mounting pin 41, creating a gap between the flow path opening 32 and the membrane-like member 42, and gas is introduced from inside the mask part 2 to the connection part 3. On the other hand, when attempting to introduce gas from the connection part 3 into the mask part 2, the membrane member 42 moves upstream along the shaft of the mounting pin 41 to cover and close the flow path opening 32, thereby restricting the introduction of gas from the connection part 3 into the mask part 2. This prevents ambient air from mixing in from the discharge flow path and being introduced into the mask part 2 when the flow path switching mechanism 5, described later, switches the gas flow path of the connection part 3 to a flow path that discharges the gas in the mask part 2 to the outside of the device 1. It also prevents air that was originally present in the dead space of the connection part 3 from being introduced into the mask part 2. Therefore, as much as possible, only the subject's exhaled breath can be introduced into the collection member 6, and the subject's exhaled breath components can be adsorbed onto the collection agent, thereby improving the accuracy of breath analysis.

[0024] On the other hand, the collection member side member 33 is a horizontally elongated rectangular plate-like body with a through-hole forming an exhalation inlet 34 in the center, and a collection member housing section 35 is formed on the outer circumference of the through-hole of the plate-like body, consisting of an annular groove projecting toward the downstream side of the gas flow path. The collection member 6, which will be described later, is housed in the space within this collection member housing section 35. Downstream of the collection member housing section 35, a collection member housing lid 36 is arranged, which has a through-hole (gas outlet 37) with a diameter slightly smaller than the outer diameter of the collection member 6. Therefore, the exhaled air introduced from the exhalation inlet 34 of the collection member side member 33 is introduced into the collection member 6 housed in the collection member housing section 35, and the gas that has passed through the inside is discharged from the gas outlet 37 of the collection member housing lid 36.

[0025] The exhaled breath component collection device 1 according to the present invention is provided with a flow path switching mechanism 5 at the connection part 3, that is, the part that connects the mask part 2 and the collection member 6 so that they can communicate with each other, which switches between a flow path that discharges the gas in the mask part 2 to the outside of the device 1 and a flow path that introduces exhaled breath into the collection member 6. In this embodiment, the flow path switching mechanism 5 is located between the blowing port side member 31 and the collection member side member 33. The flow path switching mechanism 5 will be described in detail below.

[0026] The flow path switching mechanism 5 according to this embodiment is generally composed of a guide member 51 and two plate-shaped members 54 that slide inside and outside the guide member 51 in mutually different left-right directions. The guide member 51 is formed from a rectangular thin box that opens toward the downstream side of the gas flow path. A circular through-hole is provided in the center of the bottom surface of the box to form an exhalation inlet 52, and one vertically elongated elliptical through-hole is provided on each side of the exhalation inlet 52 to form a gas discharge flow path hole 53. In addition, notches or openings are provided on the side surfaces of the box of the guide member 51 so that the tips (free ends) of each sliding plate-shaped member 54 can protrude outside the guide member 51.

[0027] Inside the guide member 51 of this flow path switching mechanism 5, two plate-shaped members 54 made of rectangular thin plates are arranged. Each of the two plate-shaped members 54 has a rack portion 55 formed on the upper edge of the opposite surface, which is a groove that meshes with the pinion gear 58. The two plate-shaped members 54 are connected so as to be able to slide freely via a rotating shaft 59 that rotatably supports the pinion gear 58 and the pinion gear 58. The two plate-shaped members 54 are positioned so that their free ends protrude from the side of the box-shaped body of the guide member 51. When each free end is grasped and pulled outward (laterally), the plate-shaped members 54 are guided by the pinion gear 58 and the inner wall of the guide member 51, and are pulled out by sliding in different left-right directions. Each of the plate-shaped members 54 is provided with a vertically elongated elliptical groove 57 for a gas discharge channel on its free end, and a semicircular notch 56 for an exhalation introduction channel is provided on the other end, which is connected to the other plate-shaped member 54 via a pinion gear 58. The gas discharge channel grooves 57 of the plate-shaped members 54 are positioned and sized to form a gap that connects the inside and outside of the guide member 51 when the plate-shaped members 54 are almost completely housed inside the guide member 51. The exhalation introduction channel notches 56 of the plate-shaped members 54 are positioned and sized so that when the plate-shaped members 54 are pulled out from the guide member 51, the exhalation introduction channel notches 56, 56 of the two plate-shaped members 54 combine inside the guide member 51 to form a circular exhalation introduction port.

[0028] As shown in Figure 2, when the plate-shaped member 54 is stored inside the guide member 51, the plate-shaped member 54 does not form a flow path for introducing the subject's exhaled breath into the collection member 6 inside the guide member 51, and the exhaled breath inlet 52 of the guide member 51 is covered by the wall surface of the plate-shaped member 54, so no flow path is formed for introducing breath into the exhaled breath inlet 34 of the collection member side member 33 of the connecting part 3. Instead, the gas discharge flow path hole 53 of the guide member 51 and the gas discharge flow path groove 57 of the plate-shaped member 54 communicate, forming a flow path S0 that discharges at least the gas inside the mask part 2 to the outside of the device 1. On the other hand, as shown in Figure 3, when the plate-shaped member 54 is pulled out to the outside of the guide member 51, the gas discharge flow path groove 57 of the plate-shaped member 54 does not form a gap that connects the inside and outside of the guide member 51, and no flow path is formed that discharges at least the gas inside the mask part 2 to the outside of the device 1. Instead, inside the guide member 51, the exhalation introduction channel notches 56 of the two plate-shaped members 54 combine to form a roughly circular exhalation inlet. Therefore, the exhaled air introduced from the exhalation inlet 52 of the guide member 51 is introduced from the exhalation inlet formed by the combination of the exhalation introduction channel notches 56 of the two plate-shaped members 54 to the exhalation inlet 34 of the collection member side member 33.

[0029] Next, the collection member 6 will be described. The collection member 6 is constructed by filling a container with a collection agent 61 that collects exhaled breath components contained in the subject's breath, and is housed in the collection member housing section 35 of the connection section 3. As the collection agent 61, a material that can adsorb and collect general exhaled breath components or a material that can collect specific exhaled breath components can be used as appropriate. There are no particular limitations, but examples include materials containing activated carbon, zeolite, silica gel, clay minerals, etc. When the collection member 6 is housed in the collection member housing section 35 of the connection section 3, the exhaled breath inlet 62 of the collection member 6 faces the exhaled breath inlet 34 side (upstream side) of the collection member side member 33, and the gas discharge section 63 of the collection member 6 faces the collection member housing lid 36 of the connection section 3. The collection member housing lid 36 is provided to prevent the collection member 6 housed in the collection member housing section 35 from falling out. The collection member housing lid 36 is provided with a through hole (gas outlet 37) that is slightly smaller in diameter than the outer diameter of the collection member 6. Therefore, the exhaled air introduced from the exhaled air inlet 34 of the collection member side member 33 is introduced into the collection member 6 housed in the collection member housing section 35, and the gas that has passed through the inside is discharged from the gas outlet 37 of the collection member housing lid 36.

[0030] Next, the first check valve 7 will be described. In this invention, the gas outlet 37 of the connection part 3 is provided with a first check valve 7 that restricts the introduction of ambient air into the collection member 6. In this embodiment, the first check valve 7 is attached to a collection member housing lid 36 which is positioned opposite the gas outlet 63 of the collection member 6 housed in the collection member housing part 35 described above. The first check valve 7 is composed of a membrane-like member 72 and a mounting pin 71 that locks it so that it can move back and forth, and the membrane-like member 72 is formed from an inert rubber material such as a thin film of silicone rubber. The membrane-like member 72 of the first check valve 7 is locked by the mounting pin 71 having a shaft portion of a predetermined length in a position that covers the gas outlet 37 of the lid 36 from the downstream side. Therefore, when gas is discharged from the gas discharge port 63 of the collection member 6, the membrane member 72 moves downstream along the shaft of the mounting pin 71, creating a gap between the gas discharge port 37 and the membrane member 72, and gas is discharged from the gas discharge port 37 of the lid 36. On the other hand, when attempting to introduce ambient air into the collection member 6 from the gas discharge port 37 of the collection member housing lid 36, the membrane member 72 moves upstream along the shaft of the mounting pin 71, covering and closing the gas discharge port 37 of the lid 36, thus restricting the introduction of ambient air into the collection member 6 from outside the device.

[0031] Next, the cover 8 will be described with reference to Figures 1 to 3. The cover 8 consists of a bottomed cylindrical body 81 that opens toward the upstream side of the gas flow path, and a cover outlet 82, which is a through hole, is formed in the center of its bottom surface. The cover 8 is fitted and fixed in place by the inner wall of the cylindrical side surface of the cover body 81 and the outer wall forming the annular groove of the collection member housing section 35, in order to protect the collection member housing lid 36 and the first check valve 7 mounted on it. This allows the first check valve 7 mounted on the collection member housing lid 36 to be installed stably, and reliably prevents the introduction of ambient air into the collection member 6. In addition, since the tip of the device 1 is protected by the cover 8, it is possible to prevent the collection member 6, the first check valve 7, and other parts from falling off or being damaged from the connection section 3, and the handling of the device 1 is also improved.

[0032] Each component of the apparatus 1 according to this embodiment, for example, the mask portion 2, the connecting portion 3 (air intake side member 31, flow path switching mechanism 5, collection member side member 33, collection member housing lid 36), and the cover 8, may be formed as separate parts, or there may be parts that are partially formed as a single unit, as long as each component can integrally constitute the apparatus 1. If they are formed as separate parts, it is preferable that the joint portions of each component are fixed by means of fitting, bonding, welding, etc.

[0033] Next, using Figures 2 and 3, the method of using the exhaled breath component collection device 1 according to this embodiment and the method of analyzing exhaled breath components using this device 1 will be explained. First, the process before exhaled breath component collection will be explained. This process is performed with the aim of discharging the gas that was originally present in the space inside the mask part 2 and in the dead space of the connection part 3 to the outside of the device 1 without introducing it into the collection member 6. As shown in Figures 2(a) to (c), the plate-shaped member 54 of the flow path switching mechanism 5 of the exhaled breath component collection device 1 is pushed into the guide member 51, so that both plate-shaped members 54 are stored inside the guide member 51. In this state, the flow path switching mechanism 5 switches the flow path of the connection part 3 to flow path S0, which discharges at least the gas inside the mask part 2 to the outside of the device 1. In this state, the mask part 21 of the exhaled breath component collection device 1 is worn so as to cover the mouth and nose, and the facepiece 21 is tightened to the face using the tightening string 26. Since the peripheral edge 23 of the facepiece 21 is made of soft rubber or the like, it can be worn on the face without discomfort, forming a sealed space inside the mask part 2. In this state, the subject is asked to breathe normally for several minutes, not particularly limited, but for example, 30 seconds to 5 minutes, preferably 1 to 3 minutes, allowing the gas that was originally present in the space inside the mask part 2 and the dead space of the connection part 3 to be expelled outside the device 1 without being introduced into the collection member 6.

[0034] More specifically, the gas originally present in the space inside the mask part 2 (including the subject's exhaled breath after wearing the mask part 2) is introduced from the inlet 22 of the mask part 2 to the flow channel opening 32 of the inlet-side member 31 of the connection part 3. At this time, a second check valve 4 is provided in the flow channel opening 32, but as the membrane-like member 42 of the second check valve 4 moves downstream of the gas flow path along the shaft of the mounting pin 41, a gap is created between the flow channel opening 32 and the membrane-like member 42, and gas is introduced from inside the mask part 2 into the inside of the inlet-side member 31. Subsequently, the gas introduced into the inlet-side member 31 is introduced into the guide member 51 of the flow path switching mechanism 5. Since both plate-like members 54 are housed inside the guide member 51, the exhaled breath inlet 52 of the guide member 51 is covered and closed by the wall surface of the plate-like member 54, and therefore no flow path is formed to send the introduced gas to the collection member 6. Instead, the gas discharge channel hole 53 of the guide member 51 and the gas discharge channel groove 57 of the plate-shaped member 54 are in communication, forming a channel S0 that discharges gas originally present in the space inside the mask part 2 (including the subject's exhaled breath after wearing the mask part 2) to the outside of the device 1. As a result, the gas originally present in the space inside the mask part 2 and the dead space of the connection part 3 passes through the blowing port side member 31 of the connection part 3, enters the guide member 51 through the gas discharge channel hole 53 of the guide member 51 of the channel switching mechanism 5, and is discharged to the outside of the device 1 through the gap between the gas discharge channel groove 57 of the plate-shaped member 54 and the side of the box of the guide member 51. In this way, by switching the gas channel with the channel switching mechanism 5, it is possible to discharge gas originally present in the space inside the mask part 2 and the dead space of the connection part 3 to the outside of the device 1 without introducing it into the collection member 6.

[0035] Next, the process for collecting exhaled breath components will be explained. This process aims to collect exhaled breath by introducing it into the collection member 6 and adsorbing and collecting the exhaled breath components onto the collecting agent. In this process, after performing the above-described pre-exhaled breath component collection process for a predetermined time, with the mask part 2 of the exhaled breath component collection device 1 still attached, the plate-shaped member 54 of the flow path switching mechanism 5 of the exhaled breath component collection device 1 is pulled outward from the side of the box body of the guide member 51 with a finger, and both plate-shaped members 54 are slid out as shown in Figures 3(a) to (c). In this state, the flow path switching mechanism 5 switches the flow path of the connection part 3 to flow path S1, which introduces the subject's exhaled breath into the collection member 6. In this state, for several minutes, not particularly limited, but for example, about 30 seconds to 5 minutes, preferably about 1 to 3 minutes, the subject is asked to blow their breath into the inlet 22 of the mask part 2, and the subject's exhaled breath is introduced into the collection member 6 and the exhaled breath components are collected.

[0036] More specifically, when the subject blows their exhaled breath into the inlet 22 of the mask section 2, it is introduced into the flow channel opening 32 of the inlet-side member 31 of the connection section 3. At this time, a second check valve 4 is provided in the flow channel opening 32, but as the membrane-like member 42 of the second check valve 4 moves downstream of the gas flow path along the shaft of the mounting pin 41, a gap is created between the flow channel opening 32 and the membrane-like member 42, and the exhaled breath is introduced from inside the mask section 2 into the inside of the inlet-side member 31. Subsequently, the exhaled breath introduced into the inlet-side member 31 is introduced into the guide member 51 of the flow path switching mechanism 5. By extending both plate-like members 54 to the outside of the guide member 51, the gas discharge channel groove 57 of the plate-like member 54 does not form a gap connecting the inside and outside of the guide member 51, and no flow path is formed to discharge the subject's exhaled breath outside the device 1. Instead, inside the guide member 51, the exhalation introduction channel notches 56 of the two plate-shaped members 54 combine to form a roughly circular exhalation inlet. As a result, the exhaled air introduced from the exhalation inlet 52 of the guide member 51 is introduced from the exhalation inlet formed by the combination of the exhalation introduction channel notches 56 of the two plate-shaped members 54 to the exhalation inlet 34 of the collection member side member 33, and then introduced into the collection member 6 (channel S1). The gas that has passed through the collection member 6 is discharged from the gas discharge section 63 of the collection member 6. At this time, the first check valve 7 is provided in the collection member housing lid 36 facing the gas discharge port 63 of the collection member 6. However, as the membrane-like member 72 of the first check valve 7 moves downstream along the shaft of the mounting pin 71, a gap is created between the gas discharge port 37 of the collection member housing lid 36 and the membrane-like member 72, and the gas that has passed through the collection member 6 is discharged from the gas discharge port 37 of the collection member housing lid 36. On the other hand, if an attempt is made to introduce gas into the collection member 6 from the gas discharge port 37 of the collection member housing lid 36, the membrane-like member 72 moves upstream along the shaft of the mounting pin 71 to cover and close the gas discharge port 37 of the collection member housing lid 36, thus restricting the introduction of gas into the collection member 6 from the outside. In this way, by switching the gas flow path with the flow path switching mechanism 5, it is possible to introduce only the subject's exhaled breath into the collection member 6 as much as possible and adsorb and collect the subject's exhaled breath components onto the collecting agent 61.Furthermore, according to the apparatus 1 of this embodiment, since the flow path from the exhalation inlet 22 of the mask portion 2 to the gas outlet 37 via the collection member 6 is arranged in a straight line, the flow path can be shortened and it is easier to blow exhaled air into it, thereby reducing the burden on the subject involved in the collection of exhaled air components.

[0037] Next, the process for analyzing exhaled breath components will be described. Exhaled breath components are collected from the subject's breath using the process described above. The collected exhaled breath components are adsorbed and collected by the collecting agent 61, so that the exhaled breath components are less likely to deteriorate or change and are stably maintained. Until the analysis is performed, it is preferable to store the collecting member 6, which has adsorbed and collected the exhaled breath components, in a sealed container. Specifically, it is preferable to remove the collecting member 6 from the collecting member housing section 35 of the apparatus 1 and store the collecting member 6 together with the collecting agent 61 in an airtight sealed container. After that, when the preparation for analysis is complete, the collecting member 6 or collecting agent 61 is removed from the sealed container, the collecting agent is heated, and the exhaled breath components are analyzed by measuring the desorbed gas with GC / MS or the like. Furthermore, the collection member 6 that has adsorbed and collected exhaled breath components can be re-collected into a collection tube made of stainless steel or a similar material, which offers greater stability, without being stored in a sealed container. When measuring exhaled breath components, the re-collected collection tube may be used for measurement. Moreover, the collection member 6 that has adsorbed and collected exhaled breath components can be stored in a sealed container before being re-collected into a collection tube. In this way, the exhaled breath component analysis method of the present invention allows for easy and highly accurate exhaled breath analysis.

[0038] Next, with reference to Figures 4 to 6, a breath component sampling device 10 according to a second embodiment of the present invention and a breath component analysis method using this device will be described. As shown in Figure 4, the breath component sampling device 10 according to this embodiment is generally composed of a mask portion 2 that is worn on the face so as to cover the mouth and nose of a subject, a collection member 6 that collects breath components, a connecting portion 30 that connects the mask portion 2 and the collection member 6 so as to be able to communicate, a flow path switching mechanism 50 that switches between a flow path that discharges the gas inside the mask portion 2 to the outside of the device 10 and a flow path that introduces the subject's breath into the collection member 6, and a first check valve 70 that restricts the introduction of ambient air into the collection member 6 from a gas outlet 307. In this embodiment, the same components as in the first embodiment will be described using the same reference numerals. As shown in Figures 4 to 6, the flow path switching mechanism 50 of the breath component sampling device 10 according to this embodiment is generally composed of a guide member 501 and a single plate-shaped member 504 that is slidably arranged inside and outside the guide member 501.

[0039] First, the connection part 30 according to this embodiment will be described. The connection part 30 is configured to connect the mask part 2 and the collection member 6 so that they can communicate with each other, and is configured to have a gas flow path that communicates from the blowing port 22 of the mask part 2 to the exhaled air introduction port 62 of the collection member 6. As shown in Figures 4 to 6, the connection part 30 according to this embodiment includes a blowing port side member 301, a flow path switching mechanism 50, a collection member side member 303, and a collection member housing lid 306, arranged from the upstream side to the downstream side of the gas flow path. The blowing port side member 301 according to this embodiment is formed from a circular pipe with both ends open and a vertically elongated rectangular thin box body that opens toward the downstream side of the gas flow path. One end of this circular pipe is connected to the blowing port 22 of the mask part 2, and the other end is connected so as to penetrate the bottom surface of the thin box body, and the bottom surface of the box body at the connection part is provided with a flow path opening 302 which becomes a gas flow path. A second check valve 40 is provided downstream of the flow path opening 302 of the blowing port side member 301 that constitutes the connection part 30. This check valve allows gas to be introduced from inside the mask part 2 to the connection part 30, but restricts the introduction of gas from the connection part 30 into the mask part 2. The second check valve 40 is composed of a membrane-like member 402 and a mounting pin 401 that locks it so that it can move back and forth, similar to the first embodiment, and its operation and effect are the same as in the first embodiment described above. On the other hand, the collection member side member 303 is configured as a vertically elongated rectangular, slightly thick plate-like body with a through hole forming an exhalation inlet 304 towards the top and a through hole forming a gas discharge flow path hole 308 towards the bottom. The internal bore space portion of the exhalation inlet 304 of this collection member side member 303 is formed as a collection member housing part 305 in which the collection member 6 is housed. Furthermore, the area around the through-hole 308 for the gas discharge channel formed in the plate-like body of the collection member side member 303 is recessed to reduce the weight of the member. Downstream of the collection member housing section 305, a collection member housing lid 306 is positioned, which is a vertically elongated rectangular plate-like body with a through-hole (gas outlet 307) slightly smaller in diameter than the outer diameter of the collection member 6 positioned towards the top, and a through-hole (gas outlet 309) approximately the same diameter as the gas discharge channel hole 308 positioned towards the bottom.Therefore, the exhaled air introduced from the exhaled air inlet 304 of the collection member side member 303 is introduced into the collection member 6 housed in the collection member housing section 305, and the gas that passes through the inside is discharged from the gas outlet 307 of the collection member housing lid 306. On the other hand, when the flow path switching mechanism 50, which will be described later, switches to a gas flow path that discharges at least the gas from the mask section 2 to the outside of the device 10, the gas that passes through the gas discharge flow path hole 308 on the lower side of the collection member side member 303 is discharged from the gas outlet 309 of the collection member housing lid 306.

[0040] The aforementioned connection section 30 is provided with a flow path switching mechanism 50 that switches between a flow path for discharging the gas inside the mask section 2 to the outside of the device 10 and a flow path for introducing exhaled breath into the collection member 6. The flow path switching mechanism 50 according to this embodiment is positioned between the blowing port side member 301 and the collection member side member 303, and consists of a guide member 501 and a single plate-shaped member 504 that slides upward inside and outside the guide member 501. The guide member 501 is formed from a rectangular thin box that opens toward the downstream side of the gas flow path, and a circular through hole for forming an exhaled breath inlet 502 is provided on the upper side of the bottom surface of the box, and a circular through hole for forming a gas discharge flow path hole 503 is provided below the exhaled breath inlet 502. Furthermore, the upper side surface of the box surface of the guide member 501 is omitted so that the tip (free end) of the plate-shaped member 504 that slides upward can protrude outside the guide member 501. A thin plate-shaped member 504 is arranged inside the guide member 501 of the flow path switching mechanism 50. The plate-shaped member 504 is positioned so that its free end protrudes from the top of the box-shaped body of the guide member 501. When the gripping portion 506 provided on the free end side is grasped and pulled upward, the plate-shaped member 504 is guided by the inner wall of the guide member 501 and slides upward to be pulled out. The plate-shaped member 504 is provided with an exhalation introduction flow path hole 505, which is a circular through-hole, near the top, and a gripping portion 506, which is a through-hole, on the free end side for easy gripping. The exhalation introduction flow path hole 505 of the plate-shaped member 504 is positioned and sized to form a sufficient exhalation inlet when the plate-shaped member 504 is stored inside the guide member 501. Furthermore, the area below the exhalation intake hole 505 of the plate-shaped member 504 remains a wall surface. However, when the plate-shaped member 504 is stored inside the guide member 501, the wall surface portion of the plate-shaped member 504 is designed to block the gas discharge intake hole 503 of the guide member 501, preventing the formation of a gas flow path. On the other hand, when the plate-shaped member 504 is pulled out above the guide member 501, the wall surface portion of the plate-shaped member 504 is designed to block the exhalation intake port 502 of the guide member 501, preventing the formation of a gas flow path.

[0041] As shown in Figure 5, when the plate-shaped member 504 is extended above the guide member 501, the plate-shaped member 504 does not form a flow path inside the guide member 501 for introducing the subject's exhaled breath into the collection member 6, and the exhaled breath inlet 502 of the guide member 501 is covered by the wall surface of the plate-shaped member 504. Therefore, no flow path is formed for introducing breath into the exhaled breath inlet 304 of the collection member side member 303 of the connection part 30. Instead, the gas discharge flow path hole 503 of the guide member 501 communicates with the gas discharge flow path hole 308 on the lower side of the collection member side member 303 and the gas discharge port 309 of the collection member housing lid 306, forming a flow path S0 that discharges at least the gas inside the mask part 2 to the outside of the device 10. On the other hand, as shown in Figure 6, when the plate-shaped member 504 is housed inside the guide member 501, the wall portion of the plate-shaped member 504 covers and shields the gas discharge channel hole 503 of the guide member 501, so that at least no channel is formed to discharge the gas inside the mask portion 2 to the outside of the device 10. Instead, the exhalation inlet 502 of the guide member 501, the exhalation inlet channel hole 505 of the plate-shaped member 504, and the exhalation inlet 304 of the collection member side member 303 are in communication, forming an exhalation inlet channel S1. Therefore, the exhaled air introduced from the exhalation inlet 502 of the guide member 501 is introduced from the exhalation inlet channel hole 505 of the plate-shaped member 504 to the exhalation inlet 304 of the collection member side member 303.

[0042] Next, the first check valve 70 will be described. In the present invention, a first check valve 70 is provided at the gas outlet 307 of the connection part 3 to restrict the introduction of ambient air into the collection member 6. In this embodiment, the first check valve 70 is attached to a collection member housing lid 306 which is positioned opposite the gas outlet 63 of the collection member 6 housed in the collection member housing part 305 described above. The first check valve 70 is composed of a membrane-like member 702 and a mounting pin 701 which locks it so that it can move back and forth, similar to the first embodiment. The membrane-like member 702 of the first check valve 70 is locked so as to cover the gas outlet 307 on the upper side of the lid 306 from the downstream side, and its effect is the same as in the first embodiment described above. Furthermore, the cover 80 that protects the first check valve 70 consists of a rectangular box-shaped body 801 that opens toward the upstream side of the gas flow path, and a cover outlet 802 consisting of a through hole is formed in the center of its bottom surface. The cover 80 according to this embodiment is positioned to cover the gas outlet 307 on the upper side of the collection member housing lid 306 and the first check valve 70 which is provided to cover it. This allows the first check valve 70 attached to the collection member housing lid 306 to be stably installed, and reliably prevents the introduction of ambient air into the collection member 6.

[0043] Next, using Figures 5 and 6, the method of using the exhaled breath component collection device 10 according to this embodiment and the method of analyzing exhaled breath components using this device 10 will be explained. First, the process before exhaled breath component collection will be explained. This process is performed with the aim of discharging the gas that was originally present in the space inside the mask part 2 and in the dead space of the connection part 30 to the outside of the device 10 without introducing it into the collection member 6. The mask part 21 of the exhaled breath component collection device 10 is worn so as to cover the mouth and nose, and the facepiece 21 is made to fit snugly against the face using the tightening string 26. Then, as shown in Figures 5(a) and (b), the gripping part 506 of the plate-shaped member 504 of the flow path switching mechanism 50 is grasped and the plate-shaped member 504 is pulled out above the box body of the guide member 501. In this state, the flow path switching mechanism 50 switches the flow path of the connection part 30 to flow path S0, which discharges at least the gas inside the mask part 2 to the outside of the device 10. In this state, the subject is asked to breathe normally for several minutes, not particularly limited, but for example, 30 seconds to 5 minutes, preferably 1 to 3 minutes, allowing the gas originally present in the space inside the mask part 2 and the dead space of the connection part 30 to be expelled outside the device 10 without being introduced into the collection member 6. More specifically, the gas originally present in the space inside the mask part 2 (including the subject's exhaled breath after putting on the mask part 2) is introduced from the inlet 22 of the mask part 2 to the flow channel opening 302 of the inlet side member 301 of the connection part 30. At this time, a second check valve 40 is provided in the flow channel opening 302, but as the membrane member 402 of the second check valve 40 moves downstream of the gas flow path along the shaft of the mounting pin 401, a gap is created between the flow channel opening 302 and the membrane member 402, and gas is introduced from inside the mask part 2 into the inside of the inlet side member 301. Subsequently, the gas introduced into the inlet-side member 301 is introduced into the guide member 501 of the flow path switching mechanism 50. However, when the plate-shaped member 504 is slid upwards from the guide member 501, the exhalation inlet 502 of the guide member 501 is covered by the wall surface of the plate-shaped member 504, and therefore no flow path is formed to send the introduced gas to the collection member 6.Instead, the gas discharge channel hole 503 of the guide member 501, the gas discharge channel hole 308 of the collection member side member 303, and the gas discharge port 309 of the collection member housing lid 306 are connected, forming a channel S0 that discharges gas originally present in the space inside the mask part 2 (including the subject's exhaled breath after wearing the mask part 2) to the outside of the device 10. As a result, gas originally present in the space inside the mask part 2 and in the dead space of the connection part 30 passes through the blowing port side member 301 of the connection part 30, enters the guide member 501 through the gas discharge channel hole 503 of the guide member 501 of the channel switching mechanism 50, passes through the gas discharge channel hole 308 of the collection member side member 303, and is discharged to the outside of the device 10 from the gas discharge port 309 of the collection member housing lid 306. In this way, by switching the gas flow path using the flow path switching mechanism 50, it becomes possible to discharge the gas that was originally present in the space inside the mask section 2 and in the dead space of the connection section 30 to the outside of the device 10 without introducing it into the collection member 6.

[0044] Next, the process for collecting exhaled breath components will be described. This process aims to collect exhaled breath by introducing it into the collection member 6 and adsorbing and collecting the exhaled breath components onto the collecting agent. In this process, after performing the above-described pre-exhaled breath component collection process for a predetermined time, with the mask part 2 of the exhaled breath component collection device 10 still attached, the plate-shaped member 504 of the flow path switching mechanism 50 of the exhaled breath component collection device 10 is returned to the guide member 51, as shown in Figures 6(a) and (b), so that the plate-shaped member 504 is housed. In this state, the flow path switching mechanism 50 switches the flow path of the connection part 30 to flow path S1, which introduces the subject's exhaled breath into the collection member 6. In this state, for several minutes, not particularly limited, but for example, about 30 seconds to 5 minutes, preferably about 1 to 3 minutes, the subject is asked to blow their breath into the inlet 22 of the mask part 2, and the subject's exhaled breath is introduced into the collection member 6 to collect the exhaled breath components. More specifically, when the subject's exhaled breath is blown into the inlet 22 of the mask section 2, it is introduced into the flow channel opening 302 of the inlet-side member 301 of the connection section 30. At this time, a second check valve 40 is provided in the flow channel opening 302, but as the membrane-like member 402 of the second check valve 40 moves downstream of the gas flow path along the shaft of the mounting pin 401, a gap is created between the flow channel opening 302 and the membrane-like member 402, and the exhaled breath is introduced from inside the mask section 2 into the inside of the inlet-side member 301. Subsequently, the exhaled breath introduced into the inlet-side member 301 is introduced into the guide member 501 of the flow path switching mechanism 50. By housing the plate-like member 504 inside the guide member 501, the gas discharge flow path hole 503 of the guide member 501 is covered by the lower wall surface of the plate-like member 504, and therefore no flow path is formed to discharge the subject's exhaled breath outside the device 10. Instead, inside the guide member 501, the exhalation inlet 502 of the guide member 501, the exhalation inlet channel hole 505 of the plate-shaped member 504, and the exhalation inlet 304 of the collection member side member 303 are in communication, forming an exhalation inlet channel S1. As a result, exhaled air introduced from the exhalation inlet 502 of the guide member 501 is introduced from the exhalation inlet channel hole 505 of the plate-shaped member 54 to the exhalation inlet 304 of the collection member side member 303, and then introduced into the collection member 6. The gas that has passed through the collection member 6 is discharged from the gas discharge section 63 of the collection member 6.At this time, the lid 306 for housing the collection member, which faces the gas discharge port 63 of the collection member 6, is provided with a first check valve 70. However, as the membrane-like member 702 of the first check valve 70 moves downstream along the shaft of the mounting pin 701, a gap is created between the gas discharge port 307 of the lid 306 and the membrane-like member 702, and the gas that has passed through the collection member 6 is discharged from the gas discharge port 307 of the collection member housing lid 306. On the other hand, if an attempt is made to introduce gas into the collection member 6 from the gas discharge port 307 of the collection member housing lid 306, the membrane-like member 702 moves upstream along the shaft of the mounting pin 701 to cover and close the gas discharge port 307 of the lid 306, thus restricting the introduction of gas into the collection member 6 from the outside. In this way, by switching the gas flow path using the flow path switching mechanism 50, it is possible to introduce only the subject's exhaled breath into the collection member 6 as much as possible, and to adsorb and collect the subject's exhaled breath components onto the collection agent 61.

[0045] Further descriptions of the mask portion 2 and collection member 6 constituting the exhaled breath component collection device 10 in this embodiment, as well as other configurations, are the same as those of the mask portion 2 and collection member 6 and other configurations in the first embodiment described above, and their effects are also the same. Furthermore, further descriptions of the method of using the exhaled breath component collection device 10 in this embodiment and the method of analyzing exhaled breath components using this device 10 are the same as those of the first embodiment described above, and their effects are also the same.

[0046] Next, with reference to Figures 7 to 9, a breath component sampling device 11 and a breath component analysis method using this device according to a third embodiment of the present invention will be described. As shown in Figures 7 to 9, the breath component sampling device 11 according to this embodiment is generally composed of a mask portion 2 that is worn on the face so as to cover the mouth and nose of a subject, a collection member 6 that collects breath components, a connecting portion 300 that connects the mask portion 2 and the collection member 6 so as to be able to communicate, a flow path switching mechanism 500 that switches between a flow path that discharges the gas in the mask portion 2 to the outside of the device 11 and a flow path that introduces the subject's breath into the collection member 6, and a first check valve 700 that restricts the introduction of ambient air into the collection member 6 from a gas outlet 317. In this embodiment, the same components as in the first embodiment will be described using the same reference numerals. As shown in Figures 7 to 9, the flow path switching mechanism 500 of the breath component sampling device 11 according to this embodiment is generally composed of a switching valve 511 located at the branching point of a tubular member 311 that branches in three directions and constitutes the connecting portion 300.

[0047] First, the connection part 300 according to this embodiment will be described. The connection part 300 is configured to connect the mask part 2 and the collection member 6 so that they can communicate with each other, and is configured to have a gas flow path that communicates from the blowing port 22 of the mask part 2 to the exhaled air introduction part 62 of the collection member 6. As shown in Figures 7 to 9, the connection part 300 according to this embodiment is generally composed of a T-shaped tubular member 311 that branches in three directions, a flow path switching mechanism 500 arranged at the branching point corresponding to the intersection of this T shape, and a collection member housing lid 316. The tubular member 311 is provided with a flow channel 312 that connects to the blowing port 22 of the mask part 2 from the horizontal direction, thereby providing an exhalation introduction channel that introduces gas from inside the mask part 2 into the connection part 300 in the horizontal direction. An exhalation introduction channel 313a that introduces the subject's exhaled breath into the collection member 6 is located in the vertically upward direction of the tubular member 311, and a gas discharge channel 313b that discharges the gas inside the mask part 2 to the outside of the device 11 is located in the vertically downward direction.

[0048] Downstream of the gas discharge channel 313b, which is provided in the vertically downward direction of the tubular member 311, a third check valve 9 is provided that allows gas to be discharged from the gas discharge channel 313b to the outside of the device 11, but restricts the introduction of ambient air from outside the device 11 into the gas discharge channel 313b. The third check valve 9 consists of a membrane-like member 92 and a mounting pin 91 that locks it so that it can move back and forth, and is locked to a thin plate-shaped mounting frame 318, which is located at the downstream end of the gas discharge channel 313b and has a gas outlet 319 with a through hole in the center. The membrane-like member 92 of the third check valve 9 is locked by the mounting pin 91, which has a shaft portion of a predetermined length, in a position that covers the gas outlet 319 of the mounting frame 318 from the downstream side. Therefore, when gas is discharged from the gas outlet 319, the membrane member 92 moves downstream along the shaft of the mounting pin 91, creating a gap between the gas outlet 319 and the membrane member 92, allowing gas to be discharged from the gas outlet 319. On the other hand, when attempting to introduce gas into the gas discharge passage 313b from the gas outlet 319, the membrane member 92 moves upstream along the shaft of the mounting pin 91, covering the gas outlet 319, thus restricting the introduction of gas into the gas discharge passage 313b from the outside. Furthermore, this third check valve 9 is covered by a bottomed cylindrical cover 94 that opens toward the upstream side of the gas passage, and an outlet 95 consisting of a through hole is formed on the bottom surface of the cover.

[0049] On the other hand, downstream of the exhalation intake channel 313a provided vertically upward of the tubular member 311, a collection member housing section 315 is formed above (downstream of) the exhalation intake port 314 at the downstream end, where the collection member 6 is housed. Downstream (above) of the collection member housing section 315, a thin plate-shaped collection member housing lid 316 is arranged, having a through hole (gas outlet 317) with a diameter slightly smaller than the outer diameter of the collection member 6. In this embodiment, the first check valve 700 is attached to the collection member housing lid 316, which is positioned opposite the gas outlet 63 of the collection member 6 housed in the collection member housing section 315 described above. The first check valve 700 is composed of a membrane-like member 712 and a mounting pin 711 that locks it so that it can move back and forth, similar to the first embodiment. The membrane-like member 712 of the first check valve 700 is locked to cover the gas outlet 317 of the lid 316 from the downstream side (upper side), and its effect is the same as in the first embodiment described above. The cover 800 consists of a bottomed cylindrical body 811 that opens toward the upstream side of the gas flow path, and an outlet 812 consisting of a through hole is formed in the center of its bottom surface. The cover 800 is positioned to cover the gas outlet 317 of the collection member housing lid 316 and the first check valve 700. As a result, the first check valve 700 can be installed stably, and thus the introduction of ambient air into the collection member 6 can be reliably prevented.

[0050] The aforementioned connection section 300 is provided with a flow path switching mechanism 500 that switches between a flow path for discharging gas from the mask section 2 to the outside of the device 11 and a flow path for introducing exhaled breath into the collection member 6. The flow path switching mechanism 500 according to this embodiment consists of a switching valve 511 positioned at the branching point of the tubular member 311 that branches in three directions and constitutes the connection section 300. As shown in Figures 7 to 9, the switching valve 511 has an L-shaped flow path inside a cylindrical body that is rotatable in the circumferential direction. Therefore, when the switching valve 511 is rotated in the direction shown in Figure 8 to connect the vertically downward flow path 313b of the tubular member 311 with the flow path inside the switching valve 511, the flow path switching mechanism 500 does not form a flow path for introducing the subject's exhaled breath into the collection member 6, and the blowing port 22 of the mask section 2, the flow path port 312 of the tubular member 311, and the gas discharge flow path 313b are connected, forming a flow path S0 for discharging gas from the mask section 2 to the outside of the device 11. On the other hand, when the switching valve 511 is rotated in the direction shown in Figure 9 to connect the exhaled air introduction channel 313a in the vertically upward direction of the tubular member 311 with the channel inside the switching valve 511, the channel switching mechanism 500 does not form a channel to discharge the gas in the mask part 2 to the outside of the device 11. Instead, the blowing port 22 of the mask part 2, the channel port 312 of the tubular member 311, and the exhaled air introduction channel 313a are connected, forming a channel S1 for introducing exhaled air to the collection member 6.

[0051] Next, using Figures 8 and 9, the method of using the exhaled breath component collection device 11 according to this embodiment and the method of analyzing exhaled breath components using this device 11 will be explained. First, the process before exhaled breath component collection will be explained. This process is performed with the aim of discharging the gas that was originally present in the space inside the mask part 2 and in the dead space of the connection part 300 to the outside of the device 11 without introducing it into the collection member 6. Rotate the switching valve 511 of the flow path switching mechanism 500 in the direction shown in Figures 8(a) and (b) so that the flow path inside the switching valve 511 and the flow path 313b in the vertical downward direction of the tubular member 311 are connected. In this state, the flow path switching mechanism 500 switches the flow path of the connection part 300 to flow path S0, which discharges at least the gas inside the mask part 2 to the outside of the device 11. In this state, put on the mask part 21 of the exhaled breath component collection device 11 so as to cover the mouth and nose, and use the tightening string 26 to make the facepiece 21 tightly fit to the face. In this state, the subject is asked to breathe normally for several minutes, for example, 30 seconds to 5 minutes, preferably 1 to 3 minutes, without being particularly limited, allowing the gas originally present in the space inside the mask part 2 and the dead space of the connection part 300 to be discharged outside the device 11 without being introduced into the collection member 6. More specifically, the gas originally present in the space inside the mask part 2 (including the subject's exhaled breath after putting on the mask part 2) is introduced from the inlet 22 of the mask part 2 through the flow path inside the switching valve 511 into the gas discharge flow path 313b of the connection part 300. At this time, a third check valve 9 is provided at the downstream end of the gas discharge flow path 313b, but as the membrane member 92 of this third check valve 9 moves downstream of the gas flow path along the shaft of the mounting pin 91, a gap is created between the gas outlet 319 and the membrane member 92, and gas is discharged from the outlet 95 of the cover 94 via the gas outlet 319. In this way, by switching the gas flow path using the flow path switching mechanism 500, it becomes possible to discharge the gas that was originally present in the space inside the mask section 2 and in the dead space of the connection section 300 to the outside of the device 11 without introducing it into the collection member 6.

[0052] Next, the process for collecting exhaled breath components will be explained. This process is performed with the aim of introducing the subject's exhaled breath into the collection member 6 and collecting the exhaled breath components by adsorption onto the collecting agent. In this process, after performing the above-described pre-exhaled breath component collection process for a predetermined time, with the mask part 2 of the exhaled breath component collection device 11 still attached, the switching valve 511 of the flow path switching mechanism 500 of the exhaled breath component collection device 11 is rotated in the direction shown in Figures 9(a) and (b) to connect the flow path inside the switching valve 511 with the flow path 313a of the tubular member 311 in the vertical upward direction. In this state, the flow path switching mechanism 500 switches the flow path of the connection part 300 to the flow path S1 that introduces the subject's exhaled breath into the collection member 6. In this state, for several minutes, for a period not particularly limited, but for example, 30 seconds to 5 minutes, preferably 1 to 3 minutes, the subject is asked to blow their breath into the inlet 22 of the mask part 2, and the subject's breath is introduced into the collection member 6 to collect the breath components. More specifically, when the subject blows their breath into the inlet 22 of the mask part 2, the breath is introduced from the inlet 22 of the mask part 2 through the flow path in the switching valve 511 to the breath introduction flow path 313a of the connection part 300. As a result, the introduced breath is introduced into the collection member 6 from the breath introduction port 314 at the downstream end of the breath introduction flow path 313a (flow path S1). The gas that has passed through the collection member 6 is discharged from the discharge part 63 of the collection member 6. At this time, the lid 316 housing the collection member, which faces the gas discharge port 63 of the collection member 6, is provided with a first check valve 700. However, as the membrane-like member 712 of the first check valve 700 moves downstream along the shaft of the mounting pin 711, a gap is created between the gas discharge port 317 of the lid 316 and the membrane-like member 712, and the gas that has passed through the collection member 6 is discharged from the gas discharge port 317 of the collection member housing lid 316. On the other hand, if an attempt is made to introduce gas into the collection member 6 from the gas discharge port 317 of the collection member housing lid 316, the membrane-like member 712 moves upstream along the shaft of the mounting pin 711 to cover and close the gas discharge port 317 of the lid 316, thus restricting the introduction of gas into the collection member 6 from the outside. In this way, by switching the gas flow path using the flow path switching mechanism 500, it is possible to introduce only the subject's exhaled breath into the collection member 6 as much as possible, and to adsorb and collect the subject's exhaled breath components onto the collection agent 61.

[0053] Further descriptions of the mask portion 2 and collection member 6 constituting the exhaled breath component sampling device 11 in this embodiment, as well as other configurations, are the same as those of the mask portion 2 and collection member 6 and other configurations in the first embodiment described above, and their effects are also the same. Furthermore, further descriptions of the method of using the exhaled breath component sampling device 11 in this embodiment and the method of analyzing exhaled breath components using this device 11 are the same as those of the first embodiment described above, and their effects are also the same.

[0054] The present invention is not limited to the embodiments or examples described above, and its technical scope also includes various design modifications that do not depart from the gist of the invention as described in the claims. [Industrial applicability]

[0055] This invention provides a breath component sampling device and a breath component analysis method using the same, which are used for breath analysis to diagnose and evaluate diseases, pathological conditions, health status, etc., and will be widely useful in the medical and healthcare industries. [Explanation of Symbols]

[0056] 1, 10, 11 Breath component sampling device 2 Mask section 21-sided polyhedron 22 Inlet 23 Peripheral area 24 Air intake 25 Air purifying filter 26. Tightening cord 3, 30, 300 connection points 31, 301 Inlet side member 32, 302, 312 Channel mouth 33, 303 Collection member side member 34, 304, 314 Exhalation Inlet 35, 305, 315 Collection member housing section 36, 306, 316 Collection member housing lid 37, 307, 317 Gas outlet 308 Hole for gas discharge channel 309, 319 Gas outlet 311 Tubular member 313a Exhalation intake channel 313b Gas discharge channel 318 Mounting frame 4.40 Second check valve 41, 401 Mounting pins 42, 402 Membrane member 5, 50, 500 flow path switching mechanism 51, 501 Guide members 52, 502 Exhalation Inlet 53, 503 Holes for gas discharge channels 54, 504 Plate-shaped member 55 Rack section 56 Notch for exhalation intake path 57. Excavated groove for gas discharge channel (gas discharge section) 58 Pinion Gear 59 Rotating shaft 505 Hole for exhalation intake channel 506 Gripping part 511 Diverter Valve 6 Collection Member 61. Collecting agent 62 Exhalation intake section 63 Gas discharge section 7, 70, 700 First check valve 71, 701, 711 Mounting pins 72, 702, 712 Membrane members 8, 80, 800 cover 81, 801, 811 Cover body 82, 802, 812 Cover outlet 9. Third check valve 91 Mounting pins 92 Membrane member 94 Cover 95 Cover outlet S0 Gas flow path before exhaled breath component sampling S1 Gas flow path during exhaled breath component sampling

Claims

1. A breath component collection device for collecting breath components contained in the breath of a subject, The mask portion is attached to the face of the subject so as to cover the mouth and nose, and when worn, it forms a sealed space inside. A collection member is positioned on the outside of the mask portion and is filled with a collecting agent for collecting exhaled air components, The mask portion and the collection member are connected in a way that allows them to communicate with each other. The connection section is provided with a flow path switching mechanism that switches between a flow path that discharges at least the gas inside the mask to the outside of the device before exhaled breath component collection, and a flow path that introduces the subject's exhaled breath into the collection member when exhaled breath component collection is performed. The aforementioned connection portion has an outlet for discharging the gas that has passed through the collection member. A breath component sampling device characterized in that a first check valve is provided at the outlet of the connection portion for restricting the introduction of ambient air into the collection member.

2. The exhaled breath component sampling device according to claim 1, characterized in that the connection portion is provided with a second check valve that restricts the introduction of gas into the mask portion.

3. The exhaled breath component sampling device according to claim 1, characterized in that a third check valve is provided in the flow path, which is switched by the flow path switching mechanism and discharges at least the gas inside the mask to the outside of the device before exhaled breath component sampling, for which ambient air is introduced into the flow path.

4. The flow path switching mechanism comprises a guide member and two plate-shaped members arranged to slide freely inside and outside the guide member. The guide member is provided with a gas discharge channel hole and an exhalation inlet. The two plate-like members are provided with a recessed groove for a gas discharge channel and a notch for an exhaled air introduction channel, respectively. By sliding the two plate-like members, (i) The gas discharge channel hole of the guide member and the gas discharge channel groove of the plate-shaped member are connected, thereby switching to a channel that discharges at least the gas inside the mask to the outside of the device, and (ii) The breath component collection device according to claim 1 or 2, characterized in that the breath intake port of the guide member and the notch for the breath intake channel of the plate-shaped member are in communication, thereby switching to a channel for introducing the subject's breath into the collection member.

5. The flow path switching mechanism comprises a guide member and a plate-shaped member that is slidably positioned inside and outside the guide member. The guide member is provided with a gas discharge channel hole and an exhalation inlet. The plate-shaped member is provided with a hole for an exhalation intake channel. By sliding the plate-shaped member, (i) The exhalation inlet of the guide member is shielded by the wall surface of the plate-shaped member, while the gas discharge channel hole of the guide member is exposed, thereby switching to a channel that discharges at least the gas inside the mask to the outside of the device, and (ii) The breath component collection device according to claim 1 or 2, characterized in that the gas discharge channel hole of the guide member is shielded by the wall surface of the plate-shaped member, while the exhalation inlet of the guide member and the exhalation introduction channel hole of the plate-shaped member are in communication, thereby switching to a channel for introducing the subject's exhaled breath into the collection member.

6. The aforementioned connection part is equipped with a tubular member that branches in three directions, The breath component collection device according to claim 1 or 3, characterized in that the flow path switching mechanism includes a switching valve at the branching point of the tubular member that switches between a flow path for discharging at least the gas inside the mask to the outside of the device and a flow path for introducing the subject's exhaled breath into the collection member.

7. The mask portion is provided with an air intake, The exhaled air component sampling device according to any one of claims 1 to 3, characterized in that a filter for purifying ambient air is arranged at the air intake.

8. A method for analyzing exhaled breath components contained in a subject's breath using an exhaled breath component sampling device according to any one of claims 1 to 3, The process of switching the flow path of the exhaled breath component collection device to a flow path that discharges at least the gas inside the mask to the outside of the device, thereby discharging at least the gas inside the mask to the outside of the device before exhaled breath component collection, The process involves switching the flow path of the breath component collection device to one that introduces the subject's breath into the collection member, introducing the subject's breath into the collection member, and collecting the breath components by adsorbing them onto the collecting agent of the collection member. A method for analyzing breath components, characterized by comprising the steps of: heating the collecting agent of a collecting member from which breath components of a subject have been collected, and measuring the gas that has been removed.

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