An exhaled breath collection device

Abstract

The invention disclosed herein provides a breath condensate analysis cartridge adapted to be incorporated into an exhalation device. The cartridge includes a condensation zone for receiving exhaled breath, the condensation zone having a peripheral region. An analysis chamber is included in which a breath condensate sample is analyzed. A surface of the condensation zone is used to create a fluid flow path in the peripheral region. The condensation zone is connected to the analysis chamber by the fluid flow path through the peripheral region. A lip at least partially covers the peripheral region, the lip cooperating with the condensation zone to form a capillary tube to control fluid flow.

Description

Technical Field

[0001] The present invention described herein relates to a microfluidic cartridge, which typically has a size similar to a conventional credit card and is designed for medical diagnostics. This cartridge is particularly used to collect exhaled breath condensate and to provide a defined sample volume of the breath condensate within the same cartridge for immediate analysis. Inside the cartridge, the sample is always in contact with one or more surfaces of the cartridge. Background Technology

[0002] This invention relates primarily to the collection of exhaled gases from human subjects, but also from animals (typically mammalian subjects). In a first aspect, a disposable microfluidic cartridge for collecting and analyzing exhaled gases is disclosed. This cartridge is designed for integration into a larger device that provides a fluid pathway to receive and guide exhaled gases onto the cartridge, and also has processing capabilities for processing data determined by the cartridge. Once in use, the cartridge can be replaced by another cartridge prepared to receive another sample.

[0003] It is well known that analysis of exhaled gases, especially the alveolar portion, can provide valuable indicators of a subject's health. In particular, the presence or absence of certain disease marker compounds, such as hydrogen peroxide and NOx, can help diagnose or rule out specific medical conditions.

[0004] However, it is important to note that samples should be obtained correctly without contamination from unwanted components, including breathing, and also without causing excessive distress to subjects who may already be experiencing considerable difficulty breathing.

[0005] While microfluidic cells are known in the field of breath analysis, they have several drawbacks. First, the amount of sample used in the analysis is not always well controlled. This can lead to erroneous results because the volume assumed in any calculation may be inaccurate, or the concentration of reagents assumed to be dissolved in the breath condensate may be inaccurate.

[0006] Furthermore, since the mass of the components and their latent heat capacity are sufficient to affect the analytical temperature, the size of conventional boxes results in less control over the analytical temperature. In a preferred embodiment of the invention, a box with the size of a conventional credit card is provided, which therefore has a lower heat capacity, and especially when using materials similar to those used in the manufacture of credit cards, the box can also be manufactured relatively easily and cost-effectively based on conventional techniques used in the manufacture of credit cards, etc.

[0007] Lightweight, single-use diagnostic strips have been known for many years, and a specific, well-known example is the self-monitoring blood glucose (SMBG) test strip.

[0008] These glucose test strips are produced in the billions annually and have a reasonable level of accuracy, currently around 15%. When mass-produced, the production cost of an SMBG test strip is 2-5 cents. This low production cost is partly due to the volume of production and partly due to the manufacturing technology used. Manufacturing technologies may include screen printing, vapor deposition, laser ablation, and material lamination to form chambers and channels. It should be noted that SMBG test strips are typically not made by injection molding, additive manufacturing, or subtractive manufacturing. The substrate used for SMBG test strips is typically a flexible / semi-flexible polymer on which thin layers of material are laminated to construct a device with microfluidic channels and chambers.

[0009] Therefore, the object of the present invention is to solve the above-mentioned problems of known breath analyzers. Summary of the Invention

[0010] According to a first aspect of the invention, a respiratory condensate analyzer kit suitable for integration into an exhalation device is provided, the kit comprising:

[0011] A condensation zone for receiving exhaled breath, the condensation zone having an outer perimeter;

[0012] The analysis room, where samples are analyzed;

[0013] The surface of the condensation zone is used to create fluid flow paths in the peripheral area;

[0014] The condensation zone is connected to the analysis chamber via a fluid flow path that passes through the peripheral area;

[0015] The lip at least partially covers the outer area, and the lip works with the condensation zone to form capillaries, thereby controlling fluid flow.

[0016] Preferably, the condensation zone is circular, and more preferably has a diameter of 15.0-25.0 mm, and even more preferably 20.0 mm.

[0017] The surface of the condensation zone is preferably coated with a hydrophilic material or formed of a hydrophilic material, which enables the condensed fluid to form a film on the surface.

[0018] The surface of the condensation zone is preferably hydrophilic such that the angle formed with the breathing condensate is less than 20.0°, and more preferably 5.0°-15.0°. This allows the breathing condensate to flow freely out of the condensation zone and into the sensing zone.

[0019] Alternatively, the sensing zone includes vents, and the surface of the condensation zone is optionally selected to be hydrophilic such that the angle with which the breathing condensate forms is less than 23.0°–35.0° and more preferably 24.0°–26.0°. This allows for the formation of a critical mass of condensate, which then enters the sensing zone as a combined mass.

[0020] Preferably, the lip portion comprises a narrow test strip, the first end of which is adjacent to or adjacent to the analytical chamber. The width of the test strip is preferably 125-400 μm, particularly preferably 125-300 μm.

[0021] The distance between the test strip and the condensation zone is preferably 125-350 μm, and more preferably 250-300 μm.

[0022] Optionally, a portion of the condensation zone is formed of or coated with a hydrophobic material, and this portion is located near the analysis chamber and the surrounding area.

[0023] Conveniently, the overall size of the box is the same as that of a traditional credit card.

[0024] Optionally, the box has a layered structure that helps allow the box to bend and is therefore more flexible than conventional boxes used in the art. Attached Figure Description

[0025] The invention will now be described with reference to the accompanying drawings, which show two embodiments of the box by way of example only. In the drawings:

[0026] Figure 1 The components of a first embodiment of the box are shown;

[0027] Figure 2 The image shows the fluid maintained around the periphery of the condensation zone;

[0028] Figures 3a-3c The fluid flow within the box is shown;

[0029] Figures 4a-4c These are the side view, plan view, and perspective view of the base card;

[0030] Figure 5a , 5b These are the plan view and perspective view of the cover plate, respectively.

[0031] Figure 6a , 6b These are perspective views and plan views of the assembled base card and cover plate, as shown in Figures 4 and 5, respectively.

[0032] Figure 7a , 7b These are the perspective view and the plan view of the cover plate, respectively.

[0033] Figure 8a ,8b These are the perspective view and plan view of the assembled components in Figure 4-7, respectively; and

[0034] Figure 9-12 The operation of a second embodiment of the box is shown. Detailed Implementation

[0035] The object of this invention is to provide a cartridge for use in an apparatus for analyzing breath condensate. A coolable collection zone is incorporated within the cartridge, in which exhaled gas is collected. The collection zone is fluidly connected to one or more analysis zones, in which a defined volume of the collected exhaled gas is typically mixed with reagents and then analyzed to determine the presence and / or concentration of a desired analyte. The apparatus incorporating the cartridge may have functions such as identifying when a sample enters the cartridge, when sufficient sample has been collected, a processor calculating signals from the cartridge related to the ongoing assay, and a communication device transmitting readings or results to a device-mounted display or remote display.

[0036] The cartridge described in this document is designed to be fitted within a reader device. Within this device, the collection area is cooled and connected to a heat sink, such as a Peltier cooler, mounted within the device. All processes are performed within the cartridge, including: cooling the breath sample, condensing the breath sample into a thin film in the condensation zone, processing the sample, and performing final analysis. The condensation zone has a hydrophilic surface, which facilitates the movement of the sample from the collection area to the sensing area under the influence of gravity and prevents droplet formation.

[0037] The cartridge contains two main areas: a collection area and a sensing area. The condensation zone within the collection area is where exhaled breath is condensed, while the sensing area, highly integrated with the collection area, is where analyte detection and quantification are performed. Analyte detection and quantification can be performed using various analytical techniques, including UV-Vis spectroscopy, fluorescence spectroscopy, surface plasmon resonance, impedance spectroscopy, or electroanalytical chemistry. In the case of techniques including electroanalytical chemistry and impedance spectroscopy, electrodes must be present within the sensing area. These electrodes can be manufactured using various techniques, including conductive foil bonding, vapor deposition, and thick film printing. These electrodes can be applied directly to the substrate forming the cartridge's "base," or they can be printed onto a second material, which is then grooved into the cartridge's "base."

[0038] The box is preferably provided in a credit card format and size, which offers advantages from both a user and manufacturing cost perspective, as credit cards have a familiar size and shape best suited for most people and also provide a platform that facilitates large-scale and low-cost manufacturing. Credit cards comply with ISO / IEC 7810 and billions are manufactured annually, thus having a highly optimized cost structure when the supply chain is highly developed and mature.

[0039] Similar to the SMBG test strips described above, the cartridges described in this patent can be manufactured using printing and lamination processes, but unlike the SMBG test strips, they are provided in credit card form. This process allows for the use of softer materials, reducing manufacturing tolerances. Furthermore, the softer material provides compressibility, and the layered structure provides the cartridge's flexibility, making it easier to assemble into a device.

[0040] This cartridge has several functions, including collecting exhaled gas condensate. The need for condensation and collection of exhaled gas requires a phase change in the sample, imposing requirements on the cartridge not encountered in existing disposable devices designed for medical diagnostic applications. One such requirement imposed by this application is the need for a large surface area for exhaled gas collection. The amount of exhaled gas that can be collected per second is proportional to the surface area of ​​the condensation zone. If the cartridge is small, similar in size to an SMBG test strip, typically 7 mm × 20 mm, then there will not be sufficient area to collect the patient's exhaled gas within a reasonable time. The use of a credit card format in this invention allows for a circular exhaled gas collection zone with a diameter of approximately 20.0 mm. Although a diameter of 15.0–25.0 mm can be considered. This provides a large surface area for condensation, but it can be cooled and on which the patient's exhaled gas can be collected.

[0041] In this invention, sufficient patient exhalation can be collected within 60 seconds. Existing exhalation condenser collectors, positioned for the medical and medical research market, require patients to breathe for several minutes to collect a sufficient volume of sample. This is unacceptable for many clinical applications and patient populations. Considering patients with asthma, chronic obstructive pulmonary disease, cystic fibrosis, etc., these types of patients may have difficulty breathing, and therefore, requiring other breath collection kits / devices to require patients to breathe for several minutes is unreasonable and could affect the results of any downstream assays.

[0042] The cartridge described in this article is optimized to reduce patient stress because resistance to exhaled air is minimized, and the large collection area and small sample volume required reduce the duration of inhalation necessary to enter the device. Therefore, the patient rapidly provides an exhaled gas condensate sample onto the cartridge while simultaneously performing only normal Cheyne-Stokes respiration.

[0043] Due to the microfluidic features, channels, and chambers incorporated into the device, the cartridge, along with its large condensation surface, provides additional benefits to the patient. Traditional exhaled breath condensate collection devices collect approximately 100 microliters to a few milliliters of sample.

[0044] The volume requirement of existing devices means that regardless of how effective the condensation of exhaled breath is, a certain amount of time is needed to condense 100 μL or more of exhaled gas condensate. The cartridge discussed in this paper has a sensing volume of 4 μL, and this reduction in the actual required sample volume means a significant reduction in sample collection time. The volume ratio of the condensation zone to the sensing zone is approximately 10:1, which further facilitates the rapid collection of a sufficient volume.

[0045] The device described in this article further reduces the amount of sample that needs to be condensed because the condensation zone has a hydrophilic surface. The advantage of a hydrophilic surface is that droplets do not form on the surface of the condensation zone. The problem with droplet formation is that the volume of droplets is typically 10 microliters or larger. Therefore, the result of a hydrophobic surface that promotes droplet formation is that the patient needs to provide a volume of approximately 10 microliters before droplet formation. These droplets then “sit” on the surface until their mass is sufficient to overcome any hydrophobic forces and they can begin to flow. The use of a hydrophilic surface results in the formation of a film of condensate in a non-droplet form on the surface, and the film is able to begin flowing very rapidly after the first condensation of the exhalation.

[0046] When in collection mode, the cartridge is preferably held in a vertical plane, and gravity is sufficient to move the sample downwards from the collection area toward the sensing area. The movement of the exhaled gas condensate film is not random; rather, the sample tends to move toward the edge, where a lip surrounding the periphery of the collection area, in conjunction with the walls and condensation surface of the condensation area, provides a capillary channel guiding the sample. When the cartridge is in this orientation, the sample, initially moving downwards under gravity, then moves along the edge of the collection area before entering the capillary chamber located at the lowest point of the collection area. A second chamber is referred to as the sensing area / chamber. This chamber is closed around its sides (typically four) by cut laminated material, and a top cover provides a lid for the chamber. The sensing area is effectively defined but open to the collection area. The chamber is also held in a vertical plane when in collection mode and when the patient's exhaled breath enters the device.

[0047] Some exhaled gas condensation devices described elsewhere have a collection area positioned in a vertical plane, but a sensor located in a horizontal plane, where the sample is dripped from one surface to another. This configuration has the disadvantage that, in order to move as a droplet from one surface to another, the droplet must have a critical mass in order to form and detach from the surface. Similarly, a collection area and a sensing area within a cartridge in the form of a credit card and located in the same plane allow the exhaled gas condensate film to easily travel from the collection area to the sensing area. The sample is introduced into the sensing area along the wall of a capillary channel formed at the edge of the condensation area.

[0048] In this embodiment, the sensing zone is filled from bottom to top as the sample flows down the side of the chamber and then fills from the bottom up. This differs from SMBG test strips, where the sample is typically encouraged to fill the capillary in a uniform manner and from the front of the capillary, effectively pushing away any trapped air in front of the liquid sample. SMBG test strips typically have an air outlet to provide an escape path for trapped air. In this embodiment of the credit card device, the problem of trapped air is avoided as the liquid sample is guided down the wall to the bottom of the chamber, filling the chamber from the bottom. The vertical placement of the cartridge during sample collection facilitates this process.

[0049] Within this sensing chamber, reagents can be added to the sample. For electrochemical measurements of the sample, several parameters, including pH and conductivity, are carefully controlled; therefore, dry reagents are provided within the chamber for buffering and electrolyte addition. Furthermore, for specificity, it is necessary to perform measurements within the chamber designed to measure the analyte or parameter of interest. In the case of analytes such as nitric oxide, pH, and hydrogen peroxide, measurements are typically designed to produce a specific signal.

[0050] As mentioned above, assays may require the addition of reagents to the sample volume, making the ability to control fluid volume even more critical, as the additional reagents need to be subsequently dispersed to achieve a predetermined concentration. For example, in many in vitro diagnostic assays (IVDS), optically or electrochemically active materials are added to the sample. The concentration of these substances can affect the final measurement, thus influencing the precision and accuracy of the assay. The mass of these materials included in the assay is initially controlled through the manufacturing process (e.g., controlled deposition of a known mass of material into a chamber or pore), but the final concentration in the sample depends on the volume of the sample in which the material is dispersed and / or dissolved. Variations in sample volume affect the concentration of substances added to that sample, and these volume changes subsequently affect the accuracy of the assay results.

[0051] Volume control can be achieved using fixed-volume chambers, pumps, and valves, and while some of these macroscopic solutions are effective for volumes larger than milliliters, they may be less effective for microliter-scale volumes, where surface interactions are more significant than bulk properties. The invention described herein is a cartridge filled under the influence of gravity, in which a sample enters a fixed-volume chamber. The microfluidic cartridge is characterized by the fact that once the chamber is filled to the correct volume, no more liquid enters the chamber, and excess fluid remains outside the chamber, creating a very small contact point between the sample inside and outside the chamber. This small contact point acts as a choke point, resulting in very little mass or heat exchange between the fluid inside and outside the chamber.

[0052] In one embodiment of the device, a collection zone is provided where a vapor sample, such as exhaled breath, is condensed, and due to the hydrophilicity of the surface on which condensation occurs, the sample enters the sensing zone as a continuous membrane under gravity along the collection zone. A partial cap around the edge of the collection zone creates a channel for the moving membrane of the sample, which preferably follows. The flowing membrane moves into the chamber of the sensing zone; the solution, under the influence of surface tension, flows down the sides of the chamber and effectively fills the chamber from bottom to top in a continuous manner. With the fluid continuing to flow, chamber overflow can be predicted, where the overflow remains in direct contact with the sample, resulting in an unclear total volume. In the design described herein, one or more capillary sinks prevent the overflow from freely contacting the sample within the chamber. The sink is the portion that guides the fluid sample into the chamber before filling, but prevents further fluid from entering the chamber when the pressure is applied to fill the now-filled chamber. The fluid overflow does not form directly on the top of the chamber, but rather is divided into capillary sinks, and any additional sample is retained within the capillary overflow sinks.

[0053] Furthermore, the interface between the collection zones is made of and / or formed of a material such that the surface area of ​​the wetting contact between the overflow trough and the chamber containing the sample is less than 0.2 mm. 2 Therefore, it provides a very small interface between the sample in the chamber and the sample overflowing and trapped in the capillary overflow channel. When reagents are passively or actively added to the sensing chamber, the volume of the sample dissolved therein is controlled by the size of the chamber, while the overflow of other unknown sample volumes only comes into contact with the sample through the small interface, thus ensuring more precise control over the concentration of substances added to the sample in the chamber.

[0054] The interface can take the form of a structure such as a capillary. Alternatively or additionally, in addition to a hydrophilic band or channel connecting the volume inside the chamber to the overflow sample outside the chamber, the surfaces of the collection and sensing regions can be formed of a hydrophobic material. By using capillary structures to provide surface area for sample adsorption, excess sample can be further retained outside the chamber, thereby providing sufficient energy gain to prevent sample from flowing back or attempting to flow back into the sensing chamber.

[0055] This invention initially provides precise control over the sample volume within the detection chamber, and subsequently provides precise control over the concentration of any substance passively or actively added to the sample within the chamber. The final sensing volume of the sample is controlled, and any excess sample is stored outside the sensing chamber. As a result, any material added to the sample within the sensing chamber can be dissolved and dispersed to obtain a controlled final concentration for improved analysis.

[0056] The sample volume is controlled by a main chamber for capillary control that is connected to the overflow capillary chamber, eliminating the need for level sensing, active valve regulation, and / or pumping.

[0057] Please refer to the attached diagram for details. Figure 1 The internal working features of a box according to a first embodiment of the present invention are shown. The overall external dimensions of the box 10 are similar to those of the base layer 11, which is approximately 38 mm wide and 80 mm long.

[0058] Covering this is an analytical layer 12. The analytical layer 12 includes a condensation zone 13 with a diameter of approximately 20 mm, which is exposed along most of its surface and fluidly connected in use to an interface tube (not shown) of the device to receive the user's exhaled breath, which condenses into a fluid within the condensation zone 13. The surface of the condensation zone 13 is formed of or coated with a hydrophilic material that allows the exhaled condensate to spread across its surface in the form of a film. In a first embodiment, the material is hydrophilic such that the contact angle between the condensate and the material is less than 20.0°, preferably 5.0-15.0°. When the cartridge 10 is held such that the analytical zone is at its lowest point, the membrane structure allows the fluid to flow downwards along the edge of the condensation zone 13 toward the analytical chamber 15.

[0059] As mentioned earlier, it is important that the fluid volume within the analysis chamber 15 is a clearly defined volume. Therefore, to ensure that the correct volume is obtained, once the correct volume is reached, further inflow or mixing with the fluid still in the condensation zone 13 is minimized.

[0060] Therefore, in the region of the edge 14 of the condensation zone 13, lips 16a and 16b are disposed above the surface of the condensation zone 13 and parallel to the surface of the condensation zone 13. Lips 16a and 16b are located in... Figure 2 As shown in the image. From Figure 2 As can be seen in the embodiments, the lips 16a, 16b have portions 17a, 17b that are wider than the narrow test strips 19a, 19b, each having a second end terminating near the analysis chamber 15. This restricts contact between unwanted fluid and the fluid in the analysis chamber 15, or the inflow of fluid into the analysis chamber 15. The analysis chamber 15 is covered by a top 18, which, together with the bottom and walls of the analysis chamber 15, provides the correct volume of fluid required in the analysis chamber 15.

[0061] Preferably, the lip includes a narrow test strip with its second end adjacent to or adjacent to the analysis chamber, and its width is preferably 125-400 μm, particularly preferably 125-300 μm.

[0062] like Figures 3a-3cAs shown, the fluid condenses in the condensation zone 13. The condensed fluid flows around the edge of the condensation zone 13 and enters the lower region 20 of the analysis chamber 15. The flow continues until the desired amount of fluid enters the analysis chamber 15. Then, more fluid is confined below the structure of the lips 16a, 16b. In an alternative embodiment, this confinement is aided by a hydrophobic region 21 of the condensation zone 13, which separates the surfaces below the lips 16a, 16b, and region 21 of the condensation zone 13 is formed of or coated with a hydrophobic material.

[0063] Referring now to Figures 4-8, an assembly of a box according to an embodiment of the invention is shown. The assembled box has a layered structure formed by multiple layers held together in a manner known in the art. The layered structure provides the box with flexibility and strength, which is generally important, and is also important, for example, where the box can be used in agricultural environments, where conditions are not as well controlled as in medical environments. Figure 4 shows a base card 40 for supporting other elements of the box. The base card 40 is generally rectangular and has multiple cutouts and holes to receive the working elements of the box.

[0064] The base card 40 has a nearly circular central hole 41, which has a radius of 10.5 mm in an exemplary embodiment. The wall of the hole forms part of the edge of the condensation zone. Another hole 42 is shaped to accommodate a sensing zone including an analysis zone. In some embodiments, a channel 43 with a width of 2.0 mm connects the central hole 41 to the other hole 42 to allow fluid to flow between the collection zone and the sensing zone and to accommodate a sensor card including reagents, electrodes, etc., for performing analysis. A hole 44 with a radius of 3.0 mm allows the base card 40 to be secured to other elements of the cartridge using known fastening devices.

[0065] In use, the base card 40 is secured to the body of the device to which it will be incorporated. The device has a fluid passage, one end of which receives the user's exhaled breath. The second end of the fluid passage is aligned with the orifice 42 to allow exhaled gas or its components to enter.

[0066] Figure 5a , 5b A first cover sheet 50 is shown, positioned on and attached to the surface of the baseplate 40 during use. Similar to the baseplate 40, the first cover sheet 50 has a central hole 51 that forms a wall of the capacitor plate during use. The central hole 51 has a teardrop shape but a generally circular portion with a radius matching that of the central hole 41. A hole 54 allows the cover sheet 50 to be secured in place, while a channel 55 allows the cover sheet 50 to slide around any screw, pin, or other securing device that can be positioned in place.

[0067] Figures 7 and 8 show the final cover plate 70 fixed to the cover 50. The cover plate 70, typically made of a transparent material, is flat and can be secured through holes 74, which allow the securing device to pass through. One side of the cover plate 70 is largely covered by a hydrophilic material, or in some embodiments, formed of a hydrophilic material that causes exhaled air to impact and condense on it to form a film. The cover plate 70 is secured to the other elements of the aforementioned box such that the hydrophilic surface faces the holes 44, 54 and the airflow from the user's breath.

[0068] In use, in this embodiment, the cover plate 70 serves as a condenser plate and is therefore operatively connected to the cooling device in the final assembled device. A portion 71 of the cover plate 70 located within the holes 41, 51 is thus cooled, acting as a radiator against which exhaled gas impacts and condenses into a liquid phase.

[0069] As shown in Figure 8, in the outlet region from section 71 to the sensing zone, the material forming the base plate 40 extends beyond the material of the cover plate 50 in the generally triangular sections 45 and 46. The triangular sections 45 and 46 engage with the surface of the cover plate 70 and the walls of the holes 41 and 51 to form capillaries that draw excess liquid away from the sensing zone and thus provide the correct volume within the sensing zone. The distance between the triangular sections and the condensation zone is preferably 125-350 μm, particularly preferably 250-300 μm, to provide a good capillary effect.

[0070] Preferably, the lip portion includes a narrow test strip, the first end of which is adjacent to or adjacent to the analytical chamber. The width of the test strip is preferably 125-400 μm, particularly preferably 125-300 μm.

[0071] about Figure 9-12 These figures illustrate a cartridge 90 operating according to a second embodiment of the invention to provide the desired volume of liquid in the analysis zone. The operation of the second embodiment is similar to that of the first embodiment of the invention because the surface of the condenser plate 91 allows exhaled condensate to form a film on the surface. Furthermore, the device is provided with a lip 92, a thin test strip 93, and other indicative features to ensure that the correct volume of liquid is located within the analysis zone for accurate measurement.

[0072] In the second embodiment, a hydrophilic material is selected to provide a higher contact angle with the exhaled condensate, which is 23.0-35.0°, preferably 24.0-26.0°, and more preferably 25.0°. A typical class of compounds that can be used is polyester. This initially prevents the exhaled condensate from flowing from the condenser plate 91 into the analysis zone 94 and accumulating on the plate 91.

[0073] Although the exhaled condensate still forms a film on the surface of the hydrophilic material, once a critical mass has accumulated, this will cause the film to collapse and the liquid to flow into the analysis zone 94. Because of the rapid liquid flow, the chance of air escaping into the analysis zone 94 towards the condenser plate 91 is reduced, and air entering the analysis zone 94 will prevent liquid from flowing in. Therefore, an vent 95 is provided, the diameter of which is insufficient to allow liquid to flow through. The vent 95 includes a channel measuring 3 × 0.12 mm and 0.2 mm in length, leading to an outlet region measuring 4 × 0.45 mm and 3 mm in length. Thus, when the liquid enters the analysis zone 94, air... Figure 11 As indicated by the middle arrow A, the liquid is discharged through the pores. Therefore, the analysis zone 94 is not filled with cavitation at all, and any excess liquid is absorbed by the thin test strip 93 and the lip 92.

Claims

1. A respiratory condensate analyzer kit suitable for integration into an exhalation device, the kit comprising: A condensation zone for receiving exhaled gases, the condensation zone having a peripheral area; The analysis room, where samples are analyzed; The surface of the condensation zone is used to create fluid flow paths in the peripheral area; The condensation zone is connected to the analysis chamber via a fluid flow path that passes through the peripheral area; A lip that at least partially covers the peripheral area, the lip cooperating with the condensation zone to form a capillary, thereby controlling fluid flow; The lip includes a narrow test strip with its first end adjacent to or adjacent to the analysis chamber, the width of the test strip being 125-400 μm, and the distance between the test strip and the condensation zone being 125-350 μm.

2. The respiratory condensate analysis kit according to claim 1, wherein the condensation zone is circular.

3. The respiratory condensate analysis kit according to claim 2, wherein the diameter of the condensation zone is 15.0-25.0 mm.

4. The respiratory condensate analyzer according to claim 3, wherein the diameter is 20.0 mm.

5. The respiratory condensate analysis kit according to any one of claims 1 to 4, wherein the condensation zone is coated with or formed of a hydrophilic material.

6. The respiratory condensate analysis kit according to any one of claims 1 to 4, wherein the surface of the condensation zone is selected to be hydrophilic such that the angle with the respiratory condensate is less than 20.0°.

7. The respiratory condensate analyzer according to claim 6, wherein the angle is 5.0°-15.0°.

8. The respiratory condensate analysis kit according to any one of claims 1-4, wherein the respiratory condensate analysis kit includes pores, and the hydrophilicity of the surface of the condensation zone is selected such that the angle formed with the respiratory condensate is less than 23.0°-35.0°.

9. The respiratory condensate analyzer according to claim 8, wherein the angle is selected from 24.0°-26.0°.

10. The respiratory condensate analysis kit according to claim 1, wherein the width of the test strip is 125-300 μm.

11. The respiratory condensate analysis kit according to claim 1, wherein the distance is 250-300 μm.

12. The respiratory condensate analysis kit according to any one of claims 1 to 4, wherein a portion of the condensation zone is formed of or coated with a hydrophobic material, the portion being located near the analysis chamber and the peripheral area.

13. The respiratory condensate analyzer according to any one of claims 1 to 4, wherein the overall size of the analyzer is the size of a conventional credit card.

14. The respiratory condensate analysis kit according to any one of claims 1 to 4, wherein the layered structure of the kit facilitates bending of the kit.

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