Sampling device

Abstract

A sample collection device for collecting end-exhalation exhalation samples includes an inlet port for the entry of a respiratory sample, an air storage reservoir connected to the inlet port for storing exhaled air, and an outlet port for releasing the stored air, wherein the inlet port is provided with a pressure-operated one-way valve, which allows air to pass from the inlet port to the air storage reservoir when the user exhales into the inlet port, and the outlet port includes a clamping mechanism for stopping the release of air when operated by the user.

Description

Technical Field

[0001] The present invention provides a system and method for collecting an exhaled sample.

Background Art

[0002] Any discussion of background art throughout this specification should in no way be construed as an admission that such art is widely known or forms part of common general knowledge in the field.

[0003] Point-of-care (POC) and patient self-testing improve patient medical decision-making by providing the information necessary for rapid decisions to healthcare professionals, enhancing the quality and efficiency of healthcare.

[0004] Analysis of biological samples by portable devices plays an important role in point-of-care and self-testing for disease diagnosis and health monitoring. However, the conventional technologies have many limitations. Blood analysis is highly reliable and can provide real-time information, but its sampling methods (finger puncture or arterial sampling) are painful and invasive. On the other hand, urine sampling is non-invasive, but the sampling process is complicated and the results may not be obtained in a timely manner.

[0005] As a real-time, painless, and non-invasive alternative for sampling biological molecules, there is increasing interest in the analysis of volatile organic compounds (VOCs) in exhaled breath as biomarkers for various diseases including esophageal and gastric cancer, colorectal cancer, lung cancer, breast cancer, liver disease, asthma, chronic obstructive pulmonary disease, and inflammatory bowel disease.

[0006] Photonic sensing technology exists for measuring acetone from exhaled breath, and this technology can be used for monitoring diabetic ketoacidosis (DKA) and managing ketosis for health-conscious applications. Despite the inherent advantages and promising potential applications of breath testing, it remains an underutilized diagnostic tool in actual clinical practice.

[0007] A major obstacle to VOC measurement from exhaled breath is the lack of standardization in exhaled breath sampling.

[0008] Figure 1 shows a typical gas exchange, or capnography, tracking the concentration of CO2 as the reference gas. Gas exchange from exhalation can be divided into three phases 2-4. In phase I (2), the exhalation comes from dead space where gas exchange does not occur (e.g., mouth, trachea, and bronchi), and therefore the measured gas concentration is at baseline. In phase III (4), the exhalation comes from the alveoli, where gas exchange takes place, and the target gas concentration is highest in this portion of the exhalation. Phase II (3) is the transition phase between phase I and phase III.

[0009] Exhaled breath sampling can be broadly classified into three categories: mixed exhalation, late exhalation, and end-of-expiratory sampling, each with different portions of exhaled breath collected. Mixed exhalation includes all exhaled breath from phases I, II, and III. Late exhalation includes exhaled breath from phases II and III, and end-of-expiratory sampling includes exhaled breath from phase III only. Generally, end-of-expiratory breath minimizes the influence of dead space, which indicates the highest sampling consistency and is therefore the most preferable sample.

[0010] Many existing sampling methods exist for breath analysis. Online sampling allows for continuous monitoring of breath samples, enabling real-time measurement of changes in target molecule concentrations. While this method can provide detailed analysis of the entire breath sample profile (including end-tidal phases), the time interval between each measurement is only a few hundred milliseconds. In this respect, the amount of target molecule for analysis is at an extremely low level and therefore can only be measured with ultra-sensitive instruments such as mass spectrometry, making it impractical for any dispersed application.

[0011] Figure 2 shows a conventional disposable airbag 20, another widely known means of sampling exhaled breath. Typical airbags are made of composite aluminum foil or a VOC-impermeable soft material such as Tedlar and can be easily folded to a small size for portable use. Figure 3 shows an exemplary face mask 31 and sample collection airbag 32. During sample collection, the user activates the sealing valve, then exhales directly into the airbag, and finally deactivates the sealing valve for temporary storage before analysis.

[0012] Despite the inherent advantages of airbags for portable use, their inherent disadvantages are significant. The main limitation of airbags is that this method can only be used to collect mixed exhaled breath, resulting in very low sampling consistency. Furthermore, because airbags are flexible and air flows in both directions through the gas inlet, backflow of sampled exhaled breath is easily caused by unconscious inhalation or by unintentionally crushing the bag. Some devices utilize an additional face mask with a one-way valve to address this problem, but face masks are very bulky.

[0013] Referring here to Figure 4, the operation of an exemplary prior art device 40 utilizing a rigid container having two openings 41, 42 is schematically shown. As shown in the figure, the container has an air inlet and an air outlet and is made of an incompressible material as the container wall to prevent the possibility of sample leakage due to unintended crushing.

[0014] As the user continues to exhale into the rigid container, the exhaled breath sample enters the container through the inlet, passes through the empty space inside, and finally exits through the outlet. When the user stops exhaling, the container captures the final portion of the exhaled breath. In this respect, the collected exhaled breath can be considered an end-of-exhalation breath sample having the same sampling volume as the internal volume of the container. Figure 5 shows a commercially available breath sample collection device known as "BioVOCC-2" 50 that uses the mechanism described above. However, all of these devices take up a lot of space even before use because a large portion of their volume is reserved for sample storage, and are not suitable for carrying outside, especially disposable devices.

[0015] To date, the development of fully portable end-of-exhalation breath sampling devices for point-of-care and self-testing applications has been slow. Providing an alternative form of sampling system would be highly significant. [Overview of the Initiative]

[0016] An object of the present invention is, in its preferred form, to provide an improved form of breath sampling for subsequent analysis.

[0017] A further aspect of the present invention provides an end-of-exhalation exhalation sampling device, the device comprising an inlet port for the entry of an exhalation sample, including a one-way inlet valve that allows a one-way inflow of the exhalation sample into an air storage reservoir; an air storage reservoir for exhalation storage connected to the inlet port; and at least one outlet port for temporarily controlling and releasing the stored air during use so as to generate positive air pressure within the air storage reservoir.

[0018] In some embodiments, at least one output port is sealable for long-term storage of breath samples in an air storage reservoir. Preferably, the one-way inlet valve includes a pressure-operated flexible one-way valve with two contacting flat surfaces that are temporarily separated by positive air pressure when the user exhales into the inlet port of the device. In some embodiments, the air storage reservoir includes a flexible, foldable bag that can be folded when not in use. The outlet port may further include a sealing mechanism to prevent subsequent leakage of the breath sample after sampling, the sealing mechanism including a clip-like structure, or the sealing mechanism including a sealing ring for sealing the output port as required.

[0019] In some embodiments, a bypass mechanism is also included for bypassing the incoming exhaled sample. The bypass mechanism helps control the flow rate of the air sample into the reservoir and reduce back pressure during exhalation. The bypass mechanism may have one or more ports. If the bypass mechanism has multiple ports, the ports may be of different sizes.

[0020] In some embodiments, the inlet port includes a moisture reduction element for reducing the moisture content of the sample. The moisture reduction element may include a structural flow member that contains highly moist incoming air for discharge through the bypass port.

[0021] According to another aspect of the present invention, a breath sampling device is provided, the device comprising an inlet port for the entry of a breath sample, an air storage reservoir connected to the inlet port for storing breath, and an outlet port for releasing the stored air, wherein the inlet port is provided with a pressure-operated one-way valve, the valve enabling the passage of air from the inlet port to the air storage reservoir when a user exhales into the inlet port, and the outlet port includes a clamping mechanism for stopping the release of air when operated by the user.

[0022] In some embodiments, a pressure-operated one-way valve includes two contacting flat surfaces separated by positive air pressure when the user exhales into the device's inlet port; an air storage reservoir includes a flexible, collapsible bag that can be folded when not in use; and an outlet port includes a sealing ring for sealing the outlet port as required. The device may also include a perforated membrane for subsequent sampling of the air in the air storage reservoir. In some embodiments, the device is operated between an inhalation state, a storage state, and an analysis state by rotation of a first adjustable part including a mouthpiece relative to a second support member; and the air reservoir is perforated by a separate adapter element for subsequent air sampling.

[0023] A further aspect of the present invention provides a breath sampling device comprising an inlet port for the entry of a breath sample, an air storage reservoir connected to the inlet port for storing breath, and an outlet port for releasing the stored air, wherein the inlet port is provided with a pressure-operated one-way valve, the valve enabling the passage of air from the inlet port to the air storage reservoir when a user exhales into the inlet port, and the outlet port includes a clamping mechanism for stopping the release of air when operated by the user.

[0024] Preferably, the pressure-operated one-way valve includes two contacting flat surfaces that are separated by positive air pressure when the user exhales into the inlet port of the device.

[0025] In some embodiments, the air storage reservoir includes a flexible, foldable bag that can be folded when not in use.

[0026] In some embodiments, the outlet port includes a sealing ring for sealing the outlet port as needed.

[0027] The embodiments have a great advantage in that they can collect an end-expiratory sample including the last part of the user's exhalation. According to a further aspect of the present invention, an end-expiratory breath sampling device is provided, which device includes an inlet port for the entry of the breath sample, an air storage reservoir for breath storage connected to the inlet port, and an outlet port for the release of the stored air.

[0028] In some embodiments, an end-expiratory breath sampling device is provided having an inlet port and an outlet port designed such that a positive air pressure is generated inside the air storage reservoir during the entry of the user's exhalation.

[0029] Preferably, the inlet port includes a mechanism for preventing backflow and leakage of the breath sample. This mechanism can include a one-way valve. Preferably, the one-way valve includes a pressure-operated flexible one-way valve including two abutting flat surfaces that are separated by a positive air pressure when the user exhales into the inlet port of the device.

[0030] In some embodiments, the air storage reservoir comprises a flexible foldable bag that can be folded when not in use. The outlet port can further include a sealing mechanism for preventing subsequent leakage of the breath sample after sampling. The sealing device can comprise a clip-like structure or a sealing ring for sealing the output port upon demand.

[0031] In some embodiments, the inlet port includes a bypass mechanism for bypassing the incoming breath sample, and the bypass mechanism serves to control the flow rate of the air sample into the reservoir and reduce the backpressure during breath entry. The bypass mechanism may have a single or multiple ports, and if there are multiple ports, the ports may be of different sizes.

[0032] In some embodiments, the inlet port includes a moisture reduction element for reducing the moisture content of the sample. In some embodiments, the moisture reduction element comprises a moisture absorbent or a mechanical element. [Brief explanation of the drawing]

[0033] Hereafter, embodiments of the present invention will be described as merely examples with reference to the attached drawings. [Figure 1] This figure shows a typical gas exchange graph tracking the concentration of CO2 as a reference gas (capnography). (Searchable at https: / / www.nuemblog.com / blog / capnography). [Figure 2] This is a photograph of a conventional composite aluminum foil airbag. It can be found at / / www.amazon.com / Sampling-1L-30Liter-Aluminum-Collection-Storage / dp / B08G8VP2VH. [Figure 3] This is a photograph of an exemplary face mask of a conventional technology for assisting breath sample collection using an airbag. It can be found at https: / / www.researchgate.net / Fig. / Breath-sampling-system-with-the-self-constructed-one-way-valve-The-one-way-valve-shifts_fig2_30813956. [Figure 4] This diagram schematically illustrates the process of collecting exhaled breath samples at the end of exhalation. [Figure 5] This diagram shows a typical commercially available device using conventional technology. It can be searched at https: / / markes.com / shop / products / biovoc-2. [Figure 6] This figure shows the CAD design output of an early prototype embodiment of the present invention. [Figure 7] This is a photograph showing an embodiment of the prototype. [Figure 8] This figure shows a cross-sectional CAD drawing of the prototype. [Figure 9] This is a schematic cross-sectional view of a prototype demonstrating its operating principle. [Figure 10] This is a photograph showing a practical prototype of one embodiment of the expanded form. [Figure 11] This is a photograph showing one embodiment of the packaged form. [Figure 12] This is a schematic cross-sectional view of a prototype demonstrating its operating principle. [Figure 13] This is a schematic cross-sectional view of a prototype demonstrating its operating principle. [Figure 14] This figure shows the operating mechanism of a sealing device for temporarily storing breath samples. [Figure 15] This figure shows the operating mechanism of a sealing device for temporarily storing breath samples. [Figure 16] This figure shows the operating mechanism of a sealing device for temporarily storing breath samples. [Figure 17] This figure shows the operating mechanism of an alternative embodiment of a sealing device for short-term storage of breath samples. Figure 17 is an end section view, and Figures 18 and 19 are schematic cross-sectional views showing the injection mechanism for stored breath samples for sample analysis using the above embodiment. [Figure 18] This figure shows the operating mechanism of an alternative embodiment of a sealing device for short-term storage of breath samples. Figure 17 is an end section view, and Figures 18 and 19 are schematic cross-sectional views showing the injection mechanism for stored breath samples for sample analysis using the above embodiment. [Figure 19] This figure shows the operating mechanism of an alternative embodiment of a sealing device for short-term storage of breath samples. Figure 17 is an end section view, and Figures 18 and 19 are schematic cross-sectional views showing the injection mechanism for stored breath samples for sample analysis using the above embodiment. [Figure 20] This is a schematic cross-sectional view showing the injection mechanism for a stored breath sample for sample analysis using the above embodiment. [Figure 21] This is a schematic cross-sectional view showing the injection mechanism for a stored breath sample for sample analysis using the above embodiment. [Figure 22] Figures 20 and 21 are photographs showing the use of the sample analyzer. [Figure 23] This is a cross-sectional view showing the mechanical design of a flow-dependent moisture remover. [Figure 24]This figure shows an alternative embodiment in its non-inflated form, with a gas inlet and outlet divided into two parts, connected to a soft reservoir bag and a one-way valve. [Figure 25] This diagram shows the configuration of Figure 24 in its expanded form. [Figure 26] This shows a further alternative embodiment. This figure shows the initial 3D model. [Figure 27] This shows a further alternative embodiment. This figure shows the configuration of Figure 26 in cross-section. [Figure 28] This shows further alternative embodiments. This figure shows the operation of the alternative embodiment while it is being stored. [Figure 29] This shows further alternative embodiments. This figure illustrates the operation of the embodiment during the analysis phase. [Figure 30] This figure shows a computer model of a further alternative sampling system, in which one-way valves are fitted to the gas inlet and outlet, and the system is divided into two separate parts, the gas inlet and outlet of which are connected to a soft reservoir bag. [Figure 31] This figure shows the storage process related to the operation of the alternative embodiment. [Figure 32] This figure shows the analysis steps for further alternative embodiments. [Modes for carrying out the invention]

[0034] To achieve the ultimate goal of collecting end-exhalation breath samples, several devices are provided in the embodiments.

[0035] The embodiment provides a disposable breath sampling device ideal for POC and self-testing applications using a handheld device. Some of the features that distinguish the breath sampling device of the embodiment from existing products are as follows: The majority of the device is made of a flexible material that can be compressed for storage and transport. It collects end-of-breath samples from exhaled breath. It includes a pressure-operated flexible airflow control valve specially designed to prevent backflow and leakage of the breath sample. It is designed to allow temporary and short-term gas sealing for storage. It is designed to bypass excess exhaled air and reduce the moisture content in the collected exhaled air.

[0036] An embodiment of the initial prototype 3D model is shown by reference numeral 60 in Figure 6, and a photograph of the actual prototype is shown by reference numeral 70 in Figure 7. Generally, this embodiment consists of a reservoir bag 61 for storing breath samples (the volume of the reservoir bag can be variable; in the early example, the volume of the developed prototype is approximately 50 mL), a pressure-operated one-way valve 62 for airflow control, and a rigid part 64 having other functional components. Since most of the present invention is made of flexible material, it can be easily packaged into a compact size for storage and transport.

[0037] Figure 8 is a cross-sectional view of the configuration shown in Figure 6, illustrating the internal operation in which the two flaps are pushed open and thereby act as a one-way input valve.

[0038] Figure 9 schematically illustrates the operation of a one-way pressure-operated valve.

[0039] Figure 10 shows an embodiment of the unfolded form 100, and Figure 11 shows an embodiment of the compactly packaged form 110.

[0040] The operating principle of this embodiment is shown with reference to Figures 12 and 13.

[0041] During sampling, the user can blow air into the device through the mouthpiece 121, thereby generating high air pressure. At this point, because the air pressure inside the one-way valve is higher than the external pressure, the membranes 122 and 123 of the one-way valve open, allowing the exhaled sample to reach the reservoir bag 124. The reservoir bag is attached to the air outlet 125, and its air inlet and outlet are carefully adjusted so that the size of the outlet is smaller than the size of the inlet. This helps to generate positive air pressure inside the reservoir, inflating the reservoir bag until it reaches the specified amount of exhaled sample to be stored. In this regard, when the user exhales into the device, the exhaled sample entering through the mouthpiece flows into the reservoir bag through the one-way valve. The exhaled sample continues to fill the bag until it reaches the specified storage volume, and then exits the device through the outlet 125.

[0042] As shown in Figure 13, when the user stops exhaling, only a portion of the end-exhalation exhalation sample is captured in the reservoir bag, and the one-way valve of the airbag, which has membranes 122 and 123, closes.

[0043] When the user stops exhaling into the sample bag, or when backflow is induced by unintentional inhalation, the air pressure inside the reservoir bag becomes higher than the air pressure inside the one-way valve. This closes the valve passage, and therefore prevents backflow of the sample inside the reservoir bag. Furthermore, the user can activate the seal 136 at the outlet 125 after sample collection. This prevents sample leakage from the outlet, and at the same time, the positive pressure generated inside the reservoir bag helps maintain the shape of the reservoir bag.

[0044] The gas outlet can be sealed by two methods. A clip-like structure is present on the rigid part. For temporary sealing after sampling, the user can lightly press the rigid part of the device, and as shown in Figures 14-16, the sealing ring around the gas outlet deforms the soft reservoir bag, blocking the airflow from the reservoir bag to the outlet. Given that backflow of air is already prevented by a pressure-operated one-way valve, the exhaled sample can be held inside the reservoir bag without the possibility of leakage.

[0045] Alternative Embodiments Referring here to Figures 17-19, an alternative embodiment may also include an additional sealing member at the gas outlet to enable short-term storage after sampling. As shown in Figures 17-19, the sealing member may be a hollow structure with one end covered with aluminum foil, and the airtightness of the member is further ensured by the use of an O-ring. During sampling (Figure 18), the sealing member is in the "off" position, and gas from the outlet can exit the device through a side air passage. After sampling, the user can push the sealing member to its "on" position (Figure 19). As a result, the air passage is blocked by the sealing member and O-ring, thereby allowing the breath sample to be captured inside the reservoir bag.

[0046] The mechanism for subsequent sample analysis of breath samples stored via injection is shown in Figures 20-22. The gas injection port of the analyzer is connected to an adapter complementary to the gas outlet of the breath sample collection device in this embodiment. Airtightness is enhanced by an O-ring inside the adapter. During gas analysis, the user inserts the gas outlet portion into the adapter, and the breath sample inside the reservoir bag can be injected into the analyzer by an active sample injector or by squeezing the reservoir bag by hand. Furthermore, for breath sample collection devices having sealing members as shown in Figures 17-19, a hollow pin 201 is located at the bottom of the adapter, which can be used to break the seal by puncturing the aluminum foil 205 before analysis.

[0047] Exhaled breath samples often contain very high levels of moisture, which can affect the operation of any gas analyzer. Furthermore, moisture tends to condense into droplets along the airway and within the sample reservoir, which can alter the concentration of target molecules in the exhaled breath sample and lead to carryover contamination. To reduce the moisture content of sampled exhaled breath, in further alternative embodiments, a mechanical design of a flow-dependent moisture remover prior to the gas inlet may be utilized.

[0048] Referring to Figure 23, a cross-sectional view of one form of the moisture remover is shown. In this design, the cross-sectional area of ​​the remover is reduced, resulting in an increased airflow rate at that location. According to general aerodynamic principles, an increased airflow rate results in a higher moisture removal rate, condensing the moisture content into larger droplets. At the rear of the moisture remover, the bypass port is aligned with the remover, while the gas inlet is oriented perpendicular to its arrangement. In this regard, most of the water droplets are released by inertia and removed through the bypass port. Apart from its moisture removal function, the bypass port also helps the user to exhale more easily and functions as a gas inlet if the user unintentionally inhales (instead of exhaling as intended by its design).

[0049] Apart from the design described above, many alternative designs are possible. For example, Figure 24 shows a potential alternative embodiment in which the gas inlet and outlet are divided into two separate parts and connected to a soft reservoir bag and a one-way valve. Figure 24 shows a non-inflated configuration having a mouthpiece 241, a membrane 242, and an outlet valve 243. Figure 25 shows an alternative embodiment of the inflated configuration.

[0050] Figures 26–29 illustrate further alternative embodiments. These embodiments provide a component comprising a fixed portion connected to a reservoir bag and an adjustable portion that can be rotated to operate in several different modes. The fixed and adjustable portions include different ports for airflow. A gas sample can only pass through if the ports from these two portions are aligned; otherwise, the airflow is blocked. A sealant is provided between the fixed and adjustable portions to ensure airtightness.

[0051] As initially shown in Figure 27, during sample collection, the device is rotated to 0 degrees, thereby opening the gas inlet and outlet via the mouthpiece, thus allowing the collection of end-expiratory respiratory samples. Referring now to Figure 28, during storage, the device is rotated to 90 degrees, thereby closing all gas ports. Referring now to Figure 29, during analysis, only outlet 291 is open.

[0052] Figures 31 to 33 show further alternative embodiments of the present invention.

[0053] Referring first to Figure 30, in this alternative embodiment, the gas inlet and outlet are divided into two individual parts 301, 302 and connected to a flexible reservoir bag 303. Both the inlet and outlet consist of one-way valves, while the outlet valve can be controlled by the user using a sealing strip 304.

[0054] The operation of the component involves three stages: sampling, storage, and analysis. During sampling, the one-way valve at the outlet is opened by a sealing strip 304, as indicated by reference numeral 300 in Figure 30. As the user continues to exhale, any excess exhaled sample is released from the outlet, and therefore only the end-of-exhalation exhaled sample is contained in the reservoir bag 303.

[0055] Referring to Figure 31, once the sampling stage is complete, the user can pull out the sealing strip 310 and activate the one-way outlet valve 311. In this regard, the exhaled breath sample is captured inside the reservoir bag for temporary storage.

[0056] As shown in Figure 32, before analyzing the breath sample, the adapter 320 is used to connect the outlet of the component to the sampling inlet of the breath analyzer. When the component is inserted into the adapter, the internal structure of the adapter pushes back the sealing strip and reopens the one-way valve at the outlet, thereby allowing the breath analyzer to discharge the breath sample for analysis.

[0057] conclusion Therefore, these embodiments can provide an improved sampling device having a one-way pressure-operated valve that allows air to flow into the reservoir and an outlet valve that can be sealed by the user during use.

[0058] interpretation Throughout this specification, the terms "one embodiment," "some embodiments," and "certain embodiments" mean that the specific features, structures, or characteristics described in relation to that embodiment are included in at least one embodiment of the present invention. Therefore, where the phrases "in one embodiment," "in some embodiments," or "in certain embodiments" appear in various places throughout this specification, they do not necessarily all refer to the same embodiment, although they may refer to the same embodiment. Furthermore, specific features, structures, or characteristics may be combined in any preferred manner in one or more embodiments, as will be apparent to those skilled in the art from this disclosure.

[0059] Where used herein, unless otherwise specified, the use of ordinal adjectives such as “first,” “second,” “third,” etc., to describe a common subject merely indicates that different instances of the same subject are being referred to, and is not intended to imply that the subjects described in this manner must be in a given order, whether temporally, spatially, in order, or by any other means.

[0060] In the following claims and description herein, the terms "comprising," "comprised of," or "which comprises" are all open terms meaning that the elements / features that follow them are included, but not excluded. Therefore, when used in the claims, the term "comprising" should not be interpreted as being limited to the means, elements, or steps listed thereafter. For example, the expression "apparatus including A and B" should not be limited to an apparatus consisting only of elements A and B. As used herein, the terms "including," "which includes," or "that includes" are all open terms meaning that the elements / features that follow them are included, but not excluded. Therefore, "including" is synonymous with "comprising" and means "comprising."

[0061] As used herein, the term “exemplary” is used to mean providing an example, not to indicate a quality. That is, “exemplary embodiment” means an embodiment provided as an example, not necessarily an embodiment of exemplary quality.

[0062] In the above description of exemplary embodiments of the present invention, it should be understood that various features of the invention may be summarized in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various embodiments of the invention. However, this method of disclosure should not be interpreted as reflecting an intention that the claimed invention requires more features than are expressly described in each claim. Rather, as reflected in the following claims, the embodiments of the invention are fewer than all the features of a single, aforementioned disclosed embodiment. Thus, the claims following the embodiments for carrying out the invention are expressly incorporated therein, and each claim stands independently as a separate embodiment of the invention.

[0063] Furthermore, while some embodiments described herein include certain features but not others, as will be understood by those skilled in the art, combinations of features from different embodiments are intended to fall within the scope of the invention and form different embodiments. For example, any of the claimed embodiments can be used in any combination within the following claims.

[0064] Furthermore, some embodiments are described herein as methods or combinations of elements of methods that can be implemented by a processor of a computer system or by other means of performing the function. Thus, a processor having the necessary instructions for performing such a method or element of a method forms means for performing the method or element of a method. Furthermore, the elements described herein in embodiments of the apparatus are examples of means for performing the function performed by the elements for the purpose of carrying out the present invention.

[0065] Numerous specific details are described in this specification. However, it is understood that embodiments of the present invention may be carried out without these specific details. In other examples, well-known methods, structures, and techniques are not shown in detail so as not to obscure the understanding of this description.

[0066] Similarly, it should be noted that the term "combined" when used in patent claims should not be interpreted as being limited only to direct connections. The terms "combined" and "connected" may be used together with their derivatives. It should be understood that these terms are not intended to be synonymous with one another. Therefore, the expression "device A combined with device B" should not be limited to a device or system in which the output of device A is directly connected to the input of device B. This means that there is a path between the output of A and the input of B, which may be a path involving other devices or means. "Combined" may mean that two or more elements are in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but still cooperate or interact with each other.

[0067] Therefore, while preferred embodiments of the present invention have been described, those skilled in the art will recognize that other and further modifications can be made to those embodiments without departing from the spirit of the invention, and that all such changes and modifications are intended to be claimed within the scope of the invention. For example, any formula given above is merely representative of the procedures that may be used. Functions may be added to or removed from the block diagram, and operations may be interchanged between function blocks. Steps may be added to or removed from the described methods within the scope of the invention.

Claims

1. An inlet port for the entry of a breath sample, including a one-way inlet valve that allows one-way flow of the breath sample into the air storage reservoir, An air storage reservoir for exhaled breath, connected to the aforementioned inlet port, End-exhalation exhalation sampling device, comprising at least one outlet port for temporarily controlling and releasing stored air during use, such that a positive air pressure is generated in the air storage reservoir.

2. The end-of-exhalation breath sampling device according to claim 1, wherein at least one output port can be sealed for long-term storage of the exhaled breath sample in the air storage reservoir.

4. The apparatus according to any of the preceding claims, wherein the one-way inlet valve includes a pressure-operated flexible one-way valve having two contacting flat surfaces that are temporarily separated by positive air pressure when a user exhales into the inlet port of the apparatus.

5. The apparatus according to any of the preceding claims, wherein the air storage reservoir comprises a flexible, foldable bag that can be folded when not in use.

6. The apparatus according to any of the preceding claims, wherein the outlet port further includes a sealing mechanism for preventing subsequent leakage of the breath sample after sampling.

7. The apparatus according to claim 6, wherein the sealing device includes a clip-shaped structure.

8. The apparatus according to claim 6, wherein the sealing mechanism comprises a sealing ring for sealing the output port as required.

9. The apparatus according to any of the preceding claims, wherein the inlet port includes a bypass mechanism for bypassing the incoming exhaled sample, the bypass mechanism helps control the flow rate of the air sample into the reservoir and reduce back pressure during exhalation.

10. The apparatus according to claim 9, wherein the bypass mechanism has one or more ports.

11. The apparatus according to claim 10, wherein the bypass mechanism has a plurality of ports, and the ports are of different sizes.

12. The apparatus according to claim 1, wherein the inlet port includes a moisture-reducing element for reducing the moisture content of the sample.

13. The apparatus according to claim 13, wherein the moisture reduction element comprises a structural flow member containing incoming air with a high moisture content for discharge from a bypass port.

14. An inlet port for the entry of a breath sample, An air storage reservoir for exhaled breath, connected to the aforementioned inlet port, A breath sampling device comprising an outlet port for releasing stored air, A pressure-operated one-way valve is provided in the inlet port, and the valve allows air to pass from the inlet port to the air storage reservoir when the user exhales into the inlet port. The device wherein the outlet port includes a clamping mechanism for stopping the release of air when operated by the user.

15. The apparatus according to claim 14, wherein the pressure-operated one-way valve includes two contacting flat surfaces that are separated by positive air pressure when a user exhales into the inlet port of the apparatus.

16. The apparatus according to claim 14, wherein the air storage reservoir includes a flexible, foldable bag that can be folded when not in use.

17. The apparatus according to claim 14, wherein the outlet port includes a sealing ring for sealing the outlet port upon request.

18. The apparatus according to any of the preceding claims, further comprising a perforated membrane for subsequent sampling of the air in the air storage reservoir.

19. The apparatus according to any of the preceding claims, which is operated between an inhalation state, a storage state, and an analysis state by rotation of a first adjustable portion including a mouthpiece relative to a second support member.

20. The apparatus according to any of the preceding claims, wherein the air reservoir is perforated by a separate adapter element for subsequent air sampling.

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