Method and apparatus for measuring breath with a breath sensor

Abstract

To provide a method and apparatus for facilitating the sampling of a user's exhaled breath in order to optimally detect physiological parameters from the breath, we provide a method and apparatus for this purpose. [Solution] The system may include a sampling unit having an exhalation sampling port, at least one pressure sensor disposed within the sampling unit and communicating with the exhalation sampling port, and a processor communicating with the at least one pressure sensor. The processor may be configured to prompt the user with instructions to exhale sample air into the exhalation sampling port for a first predetermined period and to inhale air through the exhalation sampling port for a second predetermined period. The processor may also be configured to measure pressure changes over the first and second predetermined periods via the pressure sensors, thereby determining the total amount of air corresponding to the user's lung capacity based on the pressure changes over the first and second predetermined periods.

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims the benefit of priority of U.S. Provisional Patent Application No. 62 / 955,561, filed on December 31, 2019, which is hereby incorporated by reference in its entirety.

[0002] (Field of the Invention) The present invention relates to an apparatus and method for detecting biological parameters from an exhaled breath sample. In particular, the present invention relates to an apparatus and method for facilitating the collection of an exhaled breath sample from a user via an exhalation sampling unit and for detecting various biological parameters from the exhaled breath sample.

Background Art

[0003] Health problems associated with smoking are well known. Tobacco smoke contains not only nicotine but also many other compounds and chemical additives. Tobacco smoke exposes an individual to carbon monoxide (CO) and these other compounds, many of which are carcinogenic and toxic to smokers and the people around smokers. The presence and level of CO in a smoker's exhaled breath can provide not only a marker for characterizing the overall smoking behavior of that individual but also a marker for overall exposure to other toxic compounds.

[0004] For sampling exhaled breath, a portable exhalation sensor that is easily carried by the user and does not get in the way is desirable. However, because the size of exhalation sensors is relatively small, many problems occur when capturing and accurately measuring an exhaled breath sample. Due to the relatively small size, factors such as the moisture content and exhalation temperature in the exhaled breath can affect the accuracy of the sensors used to measure the parameters.

[0005] For sampling exhaled breath, a portable breath sensor that is easy for the user to carry and unobtrusive is desirable. While this portable breath sensor can measure the user's exhaled carbon monoxide (eCO) levels, not all users may immediately understand how to use this data intuitively, as this data may not be a widely understood metric.

[0006] Electrochemical sensors are typically contained within portable breath sensors for detecting carbon monoxide levels in exhaled breath. When sampling eCO from a user, the user is usually instructed to follow breath sampling instructions, but several user compliance issues can arise. For example, the user may exhale too early or too late into the sampling device, resulting in no breath being detected; the user may exhale too gently into the sampling unit; or the user may inhale through the sampling unit before sampling begins. [Overview of the Initiative] [Problems that the invention aims to solve]

[0007] Therefore, there is still a need for methods and devices that can facilitate the sampling of a user's exhaled breath in order to optimally detect physiological parameters from the breath. [Means for solving the problem]

[0008] Specific biometric data of a user can be obtained by non-invasively detecting and quantifying the user's smoking behavior, based on measuring one or more of the user's biometric data, such as exhaled breath, to determine the level of exhaled carbon monoxide (eCO). Such measurements or data collection can be performed using a portable or stationary measurement unit, both of which communicate with one or more electronic devices to perform quantitative analysis. Alternatively, the analysis can be performed with a portable / stationary unit. However, the user may not follow the designated exhaled sampling protocol for obtaining exhaled samples. Non-compliance may result from intentional or unintentional use by the user when providing exhaled samples. For example, the user may exhale too early or too late into the sampling device, resulting in no exhaled breath being detected; the user may exhale too gently into the sampling unit; or the user may inhale through the sampling unit before sampling begins.

[0009] Therefore, by implementing specific mechanisms and methods, it is possible to ensure that breath samples are provided in a manner sufficient to reduce errors or erroneous measurements. Furthermore, the sampling unit can be used not only to detect the user's eCO levels (or other biomarker parameters) but also to determine various other biological parameters related to the user's lung health.

[0010] Examples of breath sampling devices and methods for determining and quantifying a user's eCO level are described in more detail in various patents, such as U.S. Patent Nos. 9,861,126, 10,206,572, 10,306,922, 10,335,032, and U.S. Patent Application Publication No. 2019 / 0113501, each of which is incorporated herein by reference in whole for any purpose. Any of the devices described herein can be used in conjunction with the methods and apparatus described herein.

[0011] A portable or personal sampling unit may communicate with either a personal electronic device or a computer. A personal electronic device includes, but is not limited to, a smartphone, a mobile phone, or any other personal transmitting device designed or programmed to receive data from a personal sampling unit. Similarly, a computer is intended to include a personal computer, a local server, a remote server, and the like. Data transmission from a personal sampling unit may be to either or both a personal electronic device and / or a computer. Furthermore, synchronization between the personal electronic device and the computer is optional. Any of the personal electronic device, computer, and / or personal sampling unit may transmit data to a remote server for data analysis, as described herein. Alternatively, data analysis may be performed entirely or partially via a processor contained in a local device such as a sampling unit (or computer or personal electronic device). In either case, the personal electronic device and / or computer may provide information to an individual, a caregiver, or another individual.

[0012] A personal sampling unit receives a breath sample from an individual through a collection inlet or opening. Hardware within the personal sampling unit may include any commercially available electrochemical gas sensor for detecting CO gas in the breath sample, and commercially available transmitting hardware for transmitting data (e.g., transmitting data via Bluetooth®, cellular, or other radio waves). The transmitted data, along with associated measurements and quantifications, are then displayed on either (or both) a computer display or a personal electronic device. Alternatively, or in combination, any of the information may be selectively displayed on the portable sampling unit.

[0013] In another variation of the sampling unit, the device may additionally and / or alternatively incorporate one or more spirometers for monitoring or screening various conditions, and one or more pressure transducers or pressure sensors that communicate fluidly with the sample exhaled breath. The spirometers may be incorporated into the unit to communicate fluidly with the sample exhaled breath passing through the flow path in order to detect and / or monitor parameters. One or more pressure sensors and / or spirometers may be wired to a processor within the unit, or they may communicate wirelessly with a personal electronic device or computer. Pressure sensors generally convert the pressure applied by a fluid sample into an electrical signal and may include any number of different mechanisms, such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, and optical. Spirometers can typically be used to quantify the volume and flow rate of a fluid and to assess the user's lung function, and can also help identify various lung diseases, such as asthma, pulmonary fibrosis, cystic fibrosis, and COPD.

[0014] Furthermore, the flow path may include a flow switch to increase or decrease the flow resistance along the flow path. When a subject blows into the device, they may be instructed to exhale as forcefully as possible, and the device can convert the measured pressure and volume into flow rates to calculate, for example, forced vital capacity (FVC), which is the total amount of air that can be forcibly exhaled after complete inspiration, and forced expiratory volume 1 second test (FEV1), which is the amount of air that can be forcibly exhaled over 1 second after complete inspiration. Other parameters that can be calculated by the device may include, for example, the FEV1 / FVC ratio (FEV1%), which is the ratio of FEV1 to FVC; FEF / FIF, which is the ratio of forced expiratory flow (FEF) to forced inspiratory flow (FIF) to determine the flow rate of air entering and leaving the lungs at various points in the vital capacity measurement; and peak expiratory flow (PEF), which is the maximum flow rate experienced during the vital capacity measurement test period.

[0015] Apart from the spirometer and pressure sensor, the sampling unit may also incorporate one or more temperature sensors that convert the thermal energy detected from the flow into a corresponding electrical signal. Such temperature sensors may include, for example, thermistors and thermocouples. Evaluation of exhaled breath temperature (EBT) from exhaled breath samples can be used to detect and monitor various pathological processes in the user's respiratory system, such as fever detection and asthma detection.

[0016] Using a pressure sensor, a mechanism for determining compliance with the breath sampling protocol using the user's exhaled and inhaled breath may ensure the most accurate results for the user. The user can be instructed to hold their breath for a predetermined period, for example, at least 10 seconds, to allow the CO level in their lungs to equilibrium with the level in their blood. Then, optionally, the user can be instructed to exhale into the sampling unit for a predetermined period, for example, 6-12 seconds or more. Since the user might attempt to "trick" the sampling unit to produce relatively low readings, such attempts can be prevented by properly applying exhaled and inhaled detection.

[0017] During both exhalation and inhalation, the pressure sensor within the sampling unit can measure the corresponding pressure in the flow chamber, as well as the timing of the corresponding increase and decrease in pressure. Therefore, a processor communicating with the pressure sensor can determine accordingly whether the user has followed the prescribed duration and intensity of the exhalation measurement (e.g., exhalation or inhalation). If an unexpected increase or decrease in pressure relative to the ambient pressure is detected, the user can be notified, and the device can offer corrective suggestions to the user, such as inhaling through the sampling unit when exhalation is expected or when preparing to hold one's breath. While other methods of exhalation onset detection (e.g., temperature, sound, etc.) cannot capture all modes of non-compliance with the exhalation sampling protocol, such non-compliance can be captured by using the pressure sensor 56 and timing.

[0018] Another mechanism for utilizing the pressure sensor within the sampling device is to measure the amount of air entering and leaving the exhalation sensor and use this metric to estimate and / or track the user's vital capacity as an indicator of their health. Since the flow of the user's exhalation sample through the sampling unit can be considered incompressible at the flow rates commonly encountered during exhalation and inhalation, the pressure sensor can be used to measure the resulting pressure in order to determine the relationship between the instantaneous flow rate of air through the unit and the corresponding pressure. By integrating over the duration of exhalation, the total amount of air passing through the device can be measured. The relationship between the flow rate and the pressure measured by the pressure sensor can then be established for both inhalation and exhalation. The user's total lung capacity can be determined by prompting the user to perform a complete exhalation and inhalation (or inhalation and exhalation) through the sampling unit.

[0019] Another mechanism involves providing a pressure sensor positioned perpendicular to the flow path to measure vital capacity parameters of the user's exhaled breath sample. If the minimum cross-sectional area of ​​the flow path is known, the flow rate can be calculated using dynamic pressure measurement. By recording the flow rate over time, the vital capacity parameters can be calculated via a processor. Users can be encouraged to perform these measurements regularly to inform them of their lung health.

[0020] Another mechanism involves combining the various flow rate determination methods described above with the detection of eCO (or any other biomarker). For example, the total volume of air passing through the device can be determined, and the relationship between inhaled and exhaled flow rates and pressures can also be determined. Furthermore, the flow rate over time can be recorded to calculate the user's vital capacity measurement parameters. While the user exhales a sample breath into the sampling unit, the device can be used to measure the user's eCO by measuring the present CO (or any other biomarker). In this way, eCO and lung parameters can be determined simultaneously using the same sampling unit.

[0021] Another mechanism involves determining whether the user is blocking the vents (e.g., blocking the flow path) when exhaling into or inhaling through the sampling unit (which could alter the measurement). The device can utilize multiple pressure sensors at various points in the flow path. Generally, the device can define a primary CO sensor flow path leading to an electrochemical sensor for determining eCO, and a secondary vent path allowing a portion of the sample exhaled breath to be expelled. After the user is instructed to exhale the sample exhaled breath into the sampling unit, the pressure in the CO sensor flow path can be measured, and a second pressure in the vent flow path can be measured separately from the CO sensor flow path. If any of the vent openings in either flow path are blocked, measurement errors may occur.

[0022] The pressure ratio P(VENT) / P(CO) of the vent channel to the CO sensor channel needs to remain relatively constant between samples with different flow rates, and this ratio may change if the user blocks any of the vent openings. Therefore, the pressure ratio P(VENT) / P(CO) can be calculated via the device processor for comparison between obtained samples. If any of the samples yield a significantly different ratio, this may suggest that some or all of the vent openings may be blocked, and the user may need to take corrective action.

[0023] Another mechanism involves providing feedback to the user as encouragement. After the user exhales into the sampling unit, any number of measurements can be obtained as described herein (e.g., flow rate, volume, flow pressure, etc.). This information can be provided as user feedback, such as encouragement or informational entertainment, to provide the user with a more desirable experience. For example, the total amount of air blown through the device can be recorded and reported to the user in an entertaining way (e.g., "You inflated 25 12-inch beach balls!"). Another example is that an indicator such as an auditory tone or a visual indicator can be provided, which is proportional to the flow pressure, for example, so that the user is encouraged to keep the indicator constant. Yet another example is that feedback can be provided to the user as a game, where the user can, for example, try to generate the highest possible pressure flow, which is recorded to determine improvement in lung function and compared to previous attempts.

[0024] Another mechanism involves determining whether other health problems may be present. After the user is instructed to provide a breath sample, certain parameters, such as temperature, can be measured from the breath. If an increase in breath temperature is observed, this may be an indicator of a health condition. For example, the device may determine that the user may have a fever or that the user may be experiencing some asthma symptoms.

[0025] One variation of a device configured to determine lung parameters by a user generally comprises a sampling unit having an exhalation sampling port, at least one pressure sensor located within the sampling unit and communicating with the exhalation sampling port, at least one gas sensor configured to detect an analyte of interest from a sample exhaled by the user into the exhalation sampling port, the at least one gas sensor located within the sampling unit and in fluid communication with at least a portion of the sample exhaled air, and a processor communicating with the at least one pressure sensor and the at least one gas sensor. The processor may further be configured to prompt the user with instructions to exhale a sample exhaled air into the exhalation sampling port for a first predetermined period of time. The processor may further be configured to measure a pressure change relative to ambient pressure via the pressure sensor and correlate this pressure to a flow rate. The processor may further be configured to receive a measurement from the at least one gas sensor and correlate this measurement to an analyte of interest from the sample exhaled air. The processor may further be configured to calculate the user's lung parameters based on the flow rate.

[0026] One way to determine a user's lung parameters generally involves prompting the user to exhale a sample breath into a sampling unit over a first predetermined period, measuring a first pressure change of the sample breath over the first predetermined period via a pressure sensor in communication with the sample breath, correlating the first pressure change to a flow rate via a processor in communication with the pressure sensor, measuring biological parameters from the sample breath via at least one gas sensor in fluid communication with at least a portion of the sample breath, correlating the measured values of the biological parameters to a target analyte via a processor in communication with the at least one gas sensor, and calculating the user's lung parameters via a processor based on the flow rate.

[0027] One variation of an apparatus configured to determine user sampling compliance generally includes a sampling unit having an exhalation sampling port, at least one pressure sensor disposed within the sampling unit and in communication with the exhalation sampling port, and a processor in communication with the at least one pressure sensor. The processor may be configured to prompt the user to exhale a sample breath into the exhalation sampling port over a predetermined period, measure a pressure change relative to ambient pressure via the pressure sensor upon sensing the sample breath, and measure the timing of the pressure change imparted to the pressure sensor by the sample breath. Further, the processor may be configured to compare the timing of the sample breath to the predetermined period and further compare the intensity of the pressure change to ambient pressure.

[0028] One way to determine sampling compliance by a user generally involves prompting the user to exhale a sample breath into a sampling unit over a predetermined period, receiving the sample breath through an exhalation sampling port defined on the sampling unit, measuring a pressure change relative to ambient pressure through at least one pressure sensor disposed within the sampling unit and in communication with the exhalation sampling port when the sample breath is sensed, measuring the timing of the pressure change imparted to the at least one pressure sensor by the sample breath through a processor in communication with the at least one pressure sensor, comparing the timing of the sample breath to the predetermined period, and comparing the intensity of the pressure change to the ambient pressure.

[0029] Another variation of an apparatus configured to determine sampling compliance by a user generally includes a sampling unit having an exhalation sampling port, a first pressure sensor disposed in communication with a primary flow path within the sampling unit and arranged to be in fluid communication with the exhalation sampling port, a second pressure sensor disposed in communication with a secondary flow path within the sampling unit and arranged to be in fluid communication with the exhalation sampling port and one or more ventilation openings, and a processor in communication with the first pressure sensor and the second pressure sensor, the processor being configured to obtain a first pressure measurement from the first pressure sensor, obtain a second pressure measurement from the second pressure sensor, and determine a pressure ratio of the second pressure measurement to the first pressure measurement.

[0030] Another method for determining user sampling compliance may generally include receiving a sample exhaled breath through a sampling port defined on a sampling unit, with a first portion of the sample exhaled breath flowing into a primary channel and a second portion of the sample exhaled breath flowing into a secondary channel and passing through one or more vents; obtaining a first pressure measurement via a first pressure sensor in the primary channel; obtaining a second pressure measurement via a second pressure sensor in the secondary channel; determining the pressure ratio of the second pressure measurement to the first pressure measurement via a processor communicating with the first and second pressure sensors; and, for any deviation, comparing the pressure ratio with a subsequent pressure ratio obtained from subsequent exhaled breath sample measurements. [Brief explanation of the drawing]

[0031] [Figure 1A] This figure shows a modified example of a system that can receive exhaled breath from a subject, detect various parameters, and communicate with one or more remote devices. [Figure 1B] This figure shows one modified example of the internal circuitry and sensor contained within the housing of the breath sensor. [Figure 1C] This is a top view of the flow path control device located on the sensor. [Figure 2] This is a detailed diagram of the flow path within the sampling unit and the various sensors that may be incorporated. [Figure 3A] This graph shows typical flow parameters during exhalation and inhalation. [Figure 3B] This graph shows typical flow parameters during exhalation and inhalation. [Figure 4] This is a flowchart of one mechanism for determining breathalyzer compliance. [Figure 5A] This is a flowchart of another mechanism for estimating and / or tracking lung capacity as an indicator of user health. [Figure 5B]This is a flowchart of another mechanism for estimating and / or tracking lung parameters and target analytes as indicators of user health. [Figure 6] This is a flowchart of another mechanism for measuring vital capacity parameters from a user's exhaled breath sample. [Figure 7] This flowchart illustrates yet another method for combining various flow parameter measurements with biomarker detection (e.g., eCO) from a user's breath sample. [Figure 8] This flowchart illustrates yet another method for determining whether a user is blocking a vent that could alter the measurement when exhaling into or inhaling through the sampling unit. [Figure 9] This flowchart illustrates a method for providing encouraging feedback to users. [Figure 10] This is a flowchart illustrating how to determine whether or not other health problems may be present. [Modes for carrying out the invention]

[0032] Specific biometric data of a user can be obtained by non-invasively detecting and quantifying the user's smoking behavior, based on measuring one or more of the user's biometric data, such as exhaled breath, to determine the level of exhaled carbon monoxide (eCO). Such measurements or data collection can be performed using portable or stationary measurement units, both of which communicate with one or more electronic devices to perform quantitative analysis. Alternatively, the analysis can be performed using either portable or stationary units. However, users may not follow the designated exhaled sampling protocol for obtaining exhaled samples. Non-compliance may result from intentional or unintentional use by the user when providing exhaled samples. For example, the user may exhale too early or too late into the sampling device, resulting in no exhaled breath being detected; the user may exhale too gently into the sampling unit; or the user may inhale through the sampling unit before sampling begins. Therefore, specific mechanisms and methods can be implemented to ensure that exhaled samples are provided in a manner sufficient to reduce errors or erroneous measurements. Furthermore, the sampling unit can be used not only to detect the user's eCO levels (or other biomarker parameters), but also to determine various other biological parameters related to the user's lung health.

[0033] Figure 1A shows one variation of the system and / or method in which multiple samples of biometric data are acquired and analyzed from a user to quantify the user's exposure to tobacco smoke, thereby allowing the quantified information to be relayed to the individual, healthcare providers, and / or other parties involved in the individual's health. The example discussed below uses a portable device 20 that acquires multiple breath samples from an individual using a commonly available sensor that measures the amount of eCO in the breath sample. However, quantification and information transfer are not limited to smoking exposure based on breath. As described above, there are many sampling mechanisms for acquiring a user's smoking exposure. The methods and devices described in this embodiment can be combined with or supplemented with any number of different sampling mechanisms, where possible, while still remaining within the scope of the present invention.

[0034] Measuring eCO levels is known to be a useful, immediate, and non-invasive method for assessing an individual's smoking status. Non-smokers may have eCO levels ranging from, for example, 0 ppm to 6 ppm, or more specifically, from 3.61 ppm to 5.6 ppm.

[0035] As shown in the illustration, the portable or personal sampling unit 20 can communicate with either the personal electronic device 10 or the computer 12. The personal electronic device 10 includes, but is not limited to, a smartphone, a mobile phone, or other personal transmitting device designed or programmed to receive data from the personal sampling unit 20. Similarly, the computer 12 is intended to include a personal computer, a local server, a remote server, etc. Data transmission 14 from the personal sampling unit 20 can be performed to either or both the personal electronic device 10 and / or the computer 12. Furthermore, synchronization 16 between the personal electronic device 10 and the computer 12 is optional. Any of the personal electronic device 10, the computer 12, and / or the personal sampling unit 20 can transmit data to a remote server for data analysis as described herein. Alternatively, data analysis can be performed entirely or partially via a processor contained in a local device such as the sampling unit 20 (or computer 12 or personal electronic device 10). In either case, the personal electronic device 10 and / or computer 12 can provide information to the individual, caregiver, or other individual, as shown in Figure 1A.

[0036] The personal sampling unit 20 receives a sample of breath 18 from the individual through a collection inlet or opening 22. The hardware within the personal sampling unit 20 may include any commercially available electrochemical gas sensor for detecting CO gas in the breath sample, and 14 commercially available transmitting hardware for transmitting data (e.g., transmitting data via Bluetooth®, cellular, or other radio waves). The transmitted data and associated measurements and quantifications are then displayed on either (or both) a computer display 12 or a personal electronic device 10. Alternatively, or in combination, any of the information may be selectively displayed on the portable sampling unit 20.

[0037] The personal sampling unit 20 (or personal breath unit) can also use a standard port to enable direct wired communication with the respective devices 10 and 12. In certain modifications, the personal sampling unit 20 may also include either removable or built-in memory storage, thereby enabling the memory to record and transmit data separately. Alternatively, the personal sampling unit may store and transmit data simultaneously. Further modifications of the device 20 do not require memory storage. Furthermore, the unit 20 may use any number of GPS components, inertial sensors (for tracking motion), and / or other sensors to provide additional information about the patient's behavior.

[0038] The personal sampling unit 20 may also include any number of input triggers (such as switches or sensors) 24, 26. As described below, the input triggers 24, 26 may allow an individual to prepare the device 20 for delivery of a breath sample 18, or to record other information about the cigarette smoked, such as the amount and strength of the cigarette smoked. Furthermore, variations of the personal sampling unit 20 may also associate timestamps of any inputs to the device 20. For example, the personal sampling unit 20 may associate the time the sample is provided when transmitting data 14, and provide the measured or input data along with the time of measurement. Alternatively, the personal sampling device 20 may use an alternative mechanism to determine the time when a sample is taken. For example, given a series of samples, instead of recording the timestamp of each sample, the period between each sample in the series may be recorded. Thus, by identifying the timestamp of any one sample, the timestamp of each sample in the series can be determined.

[0039] In certain modifications, the personal sampling unit 20 may have a minimal profile and be designed to be easily carried by an individual with minimal effort. Therefore, the input trigger 24 may include a low-profile tactile switch, an optical switch, a capacitive touch switch, or any commonly used switch or sensor. The portable sampling unit 20 may also provide feedback or information to the user using any number of commonly known techniques. For example, as shown, the portable sampling unit 20 may include a screen 28 that displays selection information, as discussed below. Alternatively or additionally, the feedback may take the form of vibrational elements, audible elements, and visual elements (e.g., a light source of one or more colors). Any of the feedback components may be configured to provide an alarm to the individual, which may serve as a reminder to provide a sample and / or provide feedback related to the measurement of smoking behavior. Furthermore, the feedback component can repeatedly alert the individual to remind them to provide regular breath samples in order to extend the period during which the system captures biometric data (eCO, CO level, H2, etc.) and other behavioral data (location, number of cigarettes, or other triggers, entered manually or via a GPS component coupled to the unit). In some cases, reminders can be triggered more frequently during initial programming or data capture. Once sufficient data has been obtained, the frequency of reminders can be reduced.

[0040] When acquiring a breath sample using the sampling unit 20, instructions to be displayed to the subject during the guided breath test can be provided on the personal electronic device 10 or computer display 12 to train the subject to use the unit 20. Generally, for example, on the screen 28 of the electronic device 10, the subject can be instructed to first inhale away from the unit 20 and then exhale into the unit 20 for a set period of time. The unit 20 can optionally incorporate one or more pressure sensors, for example, fluidically coupled with a check valve, to detect whether the subject is inhaling through the unit 20.

[0041] Figure 1B shows a sampling unit 20 with part of the housing 30 and the collection inlet or opening 22 removed to show a top view of the electrochemical sensor contained inside. In this modification, the first sensor 38 and the second sensor 42 (either or both of the sensors 38, 42 may include a CO sensor and an H2 sensor) are shown as being optionally positioned on their respective sensor platforms 36, 40, which may be mounted on a substrate such as a printed circuit board 44. In other modifications, one or more sensors may be used depending on the parameter to be detected. In other modifications, one or more sensors may be mounted directly on the printed circuit board 44. The power port and / or data access port 46 may also be integrated with the printed circuit board 44 and may be easily accessible by a remote device such as a computer, server, smartphone, or other device. As shown, multiple sensors 38, 42 or a single sensor can be used to detect parameters from sampled breath.

[0042] In other variations, at least one CO sensor or multiple CO sensors may be implemented individually. Alternatively, one or more CO sensors can be used in combination with one or more H2 sensors. When both CO and H2 sensors are used, many CO sensors have cross-sensitivity to H2, which is often present in amounts sufficient to potentially affect CO measurements in human exhaled breath, so readings from the H2 sensor can be used to explain or compensate for any H2 signals detected by the CO sensor. When using a CO sensor without an H2 sensor, various methods can be applied to reduce H2 measurement interference to nominally acceptable levels. However, directly measuring and compensating for the presence of H2 using an H2 sensor may facilitate CO measurement. The sensors may also include any number of different sensor types, including chemical gas sensors and electrochemical gas sensors for detecting substances such as carbon monoxide when detecting smoking-related inhaled breath.

[0043] Figure 1C shows a top view of a flow control assembly that is incorporated into a housing 20 and sealed on the sensor so that sampled air entering through the lumen is contained within the sampling unit. Sample exhaled air can enter the device when the subject exhales. The exhaled air enters a dispersion chamber 43, where the majority of the sample, e.g., about 80%, is diverted through the chamber 43 to the respective secondary fluid pathways 45, 47 defined by secondary channels 49, 51. The remaining approximately 20% of the sample enters a receiving channel 53 through a primary channel, where the exhaled air may enter through openings 55, 57 and come into contact with the sensor. In other modifications, more than 50% of the exhaled sample may be diverted so that less than 50% of the exhaled sample enters the receiving channel.

[0044] Further examples of breath sampling devices and methods for determining and quantifying eCO levels from a user are described in more detail in various patents, e.g., U.S. Patent Nos. 9,861,126, 10,206,572, 10,306,922, 10,335,032, and U.S. Patent Application Publication No. 2019 / 0113501, each of which is incorporated herein by reference in whole for any purpose. Any of the devices described herein can be used in conjunction with the methods and apparatus described herein.

[0045] In another variation of the sampling unit 20, the device may additionally and / or alternatively incorporate one or more spirometers 54 for monitoring or screening various conditions, and one or more pressure transducers or pressure sensors 56 that fluidly communicate with the sample exhaled breath 52. Although a single pressure sensor 56 is shown, additional pressure sensors may be incorporated at various locations within the sampling unit 20. The spirometer 54 may be incorporated into the unit 20 to fluidly communicate with the sample exhaled breath 52 passing through the flow path 50 to detect and / or monitor parameters, as shown in Figure 2. One or more pressure sensors 56 and / or the spirometer 54 may be wired to a processor within the unit 20, or they may communicate wirelessly with a personal electronic device 10 or a computer 12. The pressure sensors 56 generally convert the pressure applied by the fluid sample 52 into an electrical signal and may also include any number of different mechanisms, such as piezoresistive, capacitive, electromagnetic, piezoelectric, strain gauge, optical, etc. The spirometer 54 can typically be used to quantify the volume and flow rate of the fluid 52 and to evaluate the user's lung function, and can also be useful in identifying various lung diseases such as asthma, pulmonary fibrosis, cystic fibrosis, and COPD.

[0046] Furthermore, the flow path 50 may include a flow switch to increase or decrease the flow resistance along the flow path. When a subject breathes into the device, they may be instructed to exhale as forcefully as possible, and the device can convert the measured pressure and volume into flow rates to calculate, for example, forced vital capacity (FVC), which is the total amount of air that can be forced out after complete inhalation, and forced expiratory vital capacity in one second (FEV1), which is the amount of air that can be forced out over one second after complete inhalation. Other parameters that can be calculated by the device may include, for example, the FEV1 / FVC ratio (FEV1%), which is the ratio of FEV1 to FVC; FEF / FIF, which is the ratio of forced expiratory flow rate (FEF) to forced inspiratory flow rate (FIF) to determine the flow rate of air entering and leaving the lungs at various points in the vital capacity measurement; and maximum expiratory flow rate (PEF), which is the maximum flow rate experienced during the vital capacity measurement test period.

[0047] Figure 3A shows graph 60 illustrating normal values ​​for FVC, FEV1, and FEV2 25–75% across various age groups for both men and women, while Figure 3B shows graph 62 illustrating typical flow rates (liters / second) relative to volume (L) for FEF at 25%, 50%, and 75% of exhalation and FIF at 75%, 50%, and 25% of inspiration.

[0048] Apart from the spirometer 54 and pressure sensor 56, the sampling unit may also incorporate one or more temperature sensors 58 that convert thermal energy detected from the flow 52 into corresponding electrical signals, as shown in Figure 2. Such temperature sensors 58 may include, for example, thermistors and thermocouples. Evaluation of exhaled breath temperature (EBT) from an exhaled breath sample can be used to detect and monitor various pathological processes in the user's respiratory system, such as fever detection and asthma detection.

[0049] Since the most accurate results for the user can be guaranteed if the user follows the exhalation sampling protocol, one mechanism for determining exhalation test compliance using the user's exhalation and inhalation by using a pressure sensor 56 is shown in Figure 4. As shown in the figure, the user can be instructed to hold their breath for a predetermined period, for example, at least 10 seconds or more, to allow the CO level in the user's lungs to equilibrium with the level in the blood 70. Then, optionally, the user can be instructed to exhale into the sampling unit for a predetermined period, for example, 6 to 12 seconds or more 72. Since the user may try to "trick" the sampling unit to produce a relatively low reading, such attempts can be prevented by properly applying exhalation and inhalation detection.

[0050] During both exhalation and inhalation, the pressure sensor 56 in the sampling unit can measure the corresponding pressure in the flow chamber 74 and also measure the timing of the corresponding increase and decrease in pressure 76. Accordingly, a processor communicating with the pressure sensor 56 can determine whether the user followed the specified (or expected) duration and intensity of the exhalation measurement (e.g., exhalation or inhalation) by comparing it with the duration and intensity of the sample exhalation actually measured 78. For example, regarding timing, the actual timing of the sample exhalation can be compared with a specified predetermined period for exhaling into the device, and regarding exhalation intensity, the intensity of the measured pressure change can be compared with the ambient pressure level. If an unexpected increase or decrease in pressure relative to the ambient pressure is detected, and / or if the timing of the sample exhalation is outside the predetermined period, the user can be notified, and the device can provide corrective suggestions to the user, such as inhaling through the sampling unit 20 when exhalation is expected or when preparing to hold one's breath. Other methods of detecting the start of exhalation (e.g., temperature, sound, etc.) cannot capture all modes of non-compliance with the exhalation sampling protocol, but such non-compliance can be captured by using the pressure sensor 56 and timing.

[0051] Figure 5A shows a flowchart of another mechanism for measuring the amount of air entering and leaving the exhalation sensor using a pressure sensor 56 within the sampling device 20, and using this metric to estimate and / or track vital capacity as an indicator of the user's health. Since the flow of the user's exhalation sample through the sampling unit 20 may be considered incompressible at the flow rates commonly encountered during exhalation and inhalation, the pressure sensor 56 can be used to measure the resulting pressure in order to determine the relationship between the instantaneous flow rate of air through the unit 20 and the corresponding pressure. The user can be instructed to exhale into the sampling unit 80 and then inhale through the sampling unit 20 82. Optionally, the user can be further instructed to exhale through the unit 20 once more to obtain a complete exhalation-inhalation-expiration cycle through the unit 20 to measure the lung volume parameter. The total amount of air passing through the device can be measured by integrating over the period of exhalation 84. The relationship between the flow rate and the pressure measured by the pressure sensor 56 can then be established for both inhalation and exhalation 86.

[0052] The user's total lung capacity can be determined by prompting the user through the sampling unit 20 to perform a complete exhalation and inhalation, followed optionally by another exhalation (or inhalation, exhalation, and optionally another inhalation). This process can be performed and monitored periodically to provide the user with feedback on how their vital capacity changes over time. Furthermore, integration to calculate the cumulative exhaled volume over the exhalation process can help make the algorithm more accurate, for example, by helping to estimate when dead volume is consumed and alveolar air is being sampled.

[0053] Figure 5B shows yet another flowchart of the mechanism for measuring biological parameters and determining the user's lung parameters using the pressure sensor 56 and at least one sensor in the sampling device 20. As described, the user can be prompted to exhale into the sampling unit 20 for a predetermined period, for example, 6 to 12 seconds or more.80 Before exhaling, the user can optionally be instructed to hold their breath for a predetermined period, for example, at least 10 seconds or more, to allow the CO level in the user's lungs to equilibrium with the level in the blood.81 Once the user exhales the sample breath, the change in pressure imparted by the sample breath relative to the ambient pressure can be measured via at least one pressure sensor communicating with a processor in the sampling unit 20.81 The timing of exhalation can also be measured via the processor.The pressure change can then be correlated with the flow rate via the processor.83

[0054] Furthermore, one or more biological parameters can be measured from a sample breath via one or more sensors, for example, gas sensors,85 which are in fluid communication with at least a portion of the sample breath that is diverted to one or more sensors contained within the sampling unit 20 (as described above). These measurements can be obtained simultaneously with the measurement of flow parameters or from another sample breath taken in close proximity in time. The remaining sample breath can be optionally discharged from the unit 20. The biological parameter measurements obtained from one or more sensors can be correlated to an analyte of interest via a processor87, where the analyte may include the CO level from the sample breath, or any number of other analytes that indicate the user's corresponding biological parameters, such as H2, CH4, CO2, O2, C3H6O, etc. Next, the user's lung parameters can be calculated via the processor based on the flow rate obtained from the correlated pressure changes89. Thus, lung parameters and corresponding biological parameters can be obtained from a single sample breath. For the purpose of tracking the user's lung health, subsequent lung and biological parameters can be obtained from the user over a predetermined period, and these lung and biological parameters can be provided to the user as feedback.

[0055] Figure 6 shows another flowchart illustrating how a pressure sensor 56 (for example, positioned perpendicular to the flow path) can be used to measure vital capacity parameters of a user's exhaled breath sample. The user can be instructed to exhale through the sampling unit to provide a sample breath. While evaluating flow parameters can be difficult in devices with relatively high flow resistance, oriented the pressure sensor 56 perpendicular to the flow direction allows the device to calculate the flow velocity using the following dynamic pressure equation.

[0056]

number

[0057] Reconstructing equation (1) to determine the flow velocity yields the following equation.

[0058]

number

[0059] If the minimum cross-sectional area of ​​the flow path is known, the flow rate can be calculated using dynamic pressure measurement with equation (2). By recording the flow rate over time, vital capacity measurement parameters can be calculated via a processor.

[0060] Users can be encouraged to take these measurements regularly to keep them informed about their lung health. For example, users can be encouraged to take these tests before and after smoking to provide feedback on the direct impact of smoking on their health.94 Recording these values ​​over time can also help encourage users to continue reducing their tobacco intake as their lung capacity measurements improve.

[0061] Figure 7 shows another flowchart illustrating yet another method combining the methods described above with respect to Figures 5 and 6. As described above, the user can be instructed to exhale a sample breath into the sampling unit 100 and then inhale through the sampling unit 102. As described, the total volume of air passing through the device can be determined 104, and the relationship between the inhalation and exhalation flow rates and pressures can also be determined 106. Furthermore, the flow rates over time can be recorded to calculate the user's vital capacity measurement parameters 108. While the user is exhaling a sample breath into the sampling unit 100, the device can be used to measure the user's eCO by measuring the CO (or any other biomarker) present. In this way, eCO and lung parameters can be determined simultaneously using the same sampling unit 20.

[0062] Each method can utilize different flow resistances, and these flow resistances can utilize different flow path shapes through the sampling unit 20, and can also determine the biomarker sampling method used. As described above, the device can calculate expiratory and inspiratory lung volume, and can also calculate various vital capacity measurements.

[0063] Figure 8 shows yet another flowchart illustrating a method that can be used to determine whether the user is blocking the vents (e.g., blocking the flow path) when exhaling into or inhaling through the sampling unit 20 (which may alter the measurement). The device can utilize multiple pressure sensors at various points in the flow path. The device can generally define a primary CO sensor flow path leading to an electrochemical sensor for determining eCO, as shown and described herein with respect to Figure 1C, and a secondary vent path allowing a portion of the sample exhaled breath to be expelled. After the user is instructed to exhale the sample exhaled breath into the sampling unit 110, the pressure in the CO sensor flow path can be measured 112, and a second pressure in the vent flow path can be measured separately from the CO sensor flow path 114. If any of the vent openings in either flow path are blocked, errors may occur in the measurement.

[0064] The pressure ratio P(VENT) / P(CO) of the vent channel to the CO sensor channel needs to remain relatively constant between samples with different flow rates, and this ratio may change if the user blocks any of the vent openings. Therefore, the pressure ratio P(VENT) / P(CO) can be calculated via the device processor for comparison between obtained samples. If any of the samples yield a significantly different ratio, this may indicate that some or all of the vent openings are blocked, and the user may need to take corrective action.

[0065] Figure 9 shows yet another flowchart illustrating a method for providing feedback to the user as encouragement. After the user exhales into the sampling unit 120, any number of measurements can be obtained 122 as described herein (e.g., flow rate, volume, flow pressure, etc.). This information can be provided as user feedback, such as encouragement or informational entertainment 124, to provide the user with a more desirable experience. For example, the total amount of air blown through the device can be recorded and reported to the user in an entertaining way (e.g., "You inflated 25 12-inch beach balls!"). Another example is that an indicator such as an auditory tone or a visual indicator can be provided, the indicator being proportional to the flow pressure, for example, so that the user is encouraged to keep the indicator constant. Yet another example is that feedback can be provided to the user configured as a game, where the user can try to generate the highest possible pressure flow, this highest pressure flow is recorded and compared to previous attempts to determine improvement in lung function.

[0066] Figure 10 shows yet another flowchart of how to determine whether other health problems may be present. After the user is instructed to provide a breath sample 130, certain parameters such as temperature may be measured from the breath 132. If an increase in breath temperature is observed, this may be an indicator of a health condition 134. For example, the device may determine that the user may have a fever or that the user may be experiencing some asthma symptoms.

[0067] For example, any of the methods and mechanisms described with respect to Figures 4 to 10 can be combined with any physiological measuring device (e.g., pressure, vital capacity measurement, temperature, etc.) in any number of combinations to perform combined evaluation, measurement, etc., and is intended to be within the scope of this specification. For example, the physiological measuring device may also incorporate any number of additional sensors to detect various other parameters such as CO (as described), H2, CH4 (methane), CO2, O2, C3H6O (acetone), etc., as various biological functions.

[0068] While illustrative examples are given above, it will be apparent to those skilled in the art that various changes and modifications can be made therein. Furthermore, the various apparatuses or procedures described above are also intended to be used in combination with each other, as practicable. The attached claims are intended to cover all such changes and modifications that fall within the true spirit and scope of the invention.

[0069] [Implementation Method] (1) A device configured to measure a user's lung parameters, A sampling unit having an exhalation sampling port, The sampling unit includes at least one pressure sensor that is located within the sampling unit and communicates with the exhaled breath sampling port, At least one gas sensor configured to detect a target analyte from a sample exhaled by the user into the exhalation sampling port, wherein the at least one gas sensor is located within the sampling unit and is in fluid communication with at least a portion of the sample exhaled breath, The system comprises a processor that communicates with the at least one pressure sensor and the at least one gas sensor, The processor is configured to prompt the user by instructing them to exhale a sample breath into the exhalation sampling port for a first predetermined period of time. The processor is further configured to measure pressure changes relative to ambient pressure via the pressure sensor and to correlate this pressure with flow rate. The processor is further configured to receive measurements from at least one gas sensor and to correlate these measurements with the target analyte from the sample breath. The device further comprises a processor configured to calculate the user's lung parameters based on the flow rate. (2) The apparatus according to Embodiment 1, wherein the processor is configured to prompt the user by instruction to exhale at a constant flow rate or constant pressure. (3) The apparatus according to Embodiment 1, wherein the processor is configured to further prompt the user by instructing him to inhale through the exhalation sampling port for a second predetermined period of time. (4) The apparatus according to Embodiment 1, wherein the processor is further configured to prompt the user with an instruction to hold their breath for at least 10 seconds before exhaling the sample breath. (5) The apparatus according to Embodiment 1, wherein the processor is further configured to prompt the user with an instruction to exhale the sample breath for at least 6 to 12 seconds.

[0070] (6) The apparatus according to Embodiment 3, wherein the processor is further configured to prompt the user to exhale into the exhalation sampling port for a third predetermined period of time. (7) The apparatus according to Embodiment 1, wherein the at least one gas sensor is configured to sense the CO level from the sample breath. (8) The apparatus according to Embodiment 7, wherein the at least one gas sensor is configured to sense the level of H2, CH4, CO2, O2, or C3H6O. (9) A method for measuring a user's lung parameters, The first means prompting the user to exhale a sample breath into the sampling unit over a predetermined period of time, The first pressure change of the sample exhaled breath over a predetermined first period is measured via a pressure sensor in communication with the sample exhaled breath, The first pressure change is correlated with the flow rate via a processor that communicates with the pressure sensor, The biological parameters are measured from the sample breath via at least one gas sensor that is in fluid communication with at least a portion of the sample breath, Correlating the measured values ​​of the biological parameters with the target analyte via the processor that communicates with the at least one gas sensor, A method comprising calculating the user's lung parameters via the processor based on the flow rate. (10) via the pressure sensor, prompting the user to inhale through the sampling unit for a second predetermined period of time, Measuring the second pressure change of the sample exhaled breath over the second predetermined period, The method according to Embodiment 9, further comprising determining, via the processor, the total amount of air corresponding to the user's lung capacity based on the first and second pressure changes over the first and second predetermined periods.

[0071] (11) The method according to Embodiment 9, further comprising estimating the user's vital capacity over time by comparing the lung parameter with a subsequent lung parameter. (12) The method according to embodiment 9, further comprising instructing the user to hold their breath for at least 10 seconds before exhaling the sample breath. (13) The method according to embodiment 9, further comprising instructing the user to exhale the sample breath at a constant flow rate or constant pressure. (14) The method according to Embodiment 9, wherein prompting the user to exhale by instruction includes prompting the user to exhale the sample breath for at least 6 to 12 seconds. (15) The method according to embodiment 10, further comprising prompting the user to exhale into the exhalation sampling port for a third predetermined period of time.

[0072] (16) The method according to Embodiment 9, wherein measuring the biological parameters from the sample breath includes expelling the remainder of the sample breath. (17) The method according to Embodiment 9, wherein measuring the biological parameters includes sensing the CO level from the sample breath. (18) The method according to Embodiment 9, wherein measuring the biological parameters includes sensing the levels of H2, CH4, CO2, O2, or C3H6O from the sample breath. (19) A device configured to determine user sampling compliance, A sampling unit having an exhalation sampling port, The sampling unit includes at least one pressure sensor that is located within the sampling unit and communicates with the exhaled breath sampling port, The system comprises a processor that communicates with at least one pressure sensor, The processor is configured to prompt the user to exhale a sample breath into the exhalation sampling port over a predetermined period of time, to detect the sample breath, to measure the pressure change relative to the ambient pressure via the pressure sensor, and to measure the timing of the pressure change transmitted to the pressure sensor by the sample breath. The device further comprises a processor configured to compare the timing of the sample exhalation with a predetermined period of time, and to further compare the intensity of the pressure change with the ambient pressure. (20) The apparatus according to embodiment 19, wherein the processor is further configured to prompt the user with an instruction to hold their breath for at least 10 seconds before exhaling the sample breath.

[0073] (21) The apparatus according to embodiment 19, wherein the processor is further configured to prompt the user with an instruction to exhale the sample breath for at least 6 to 12 seconds. (22) The apparatus according to embodiment 19, wherein the processor is further configured to prompt the user when the pressure sensor detects a negative pressure change during the predetermined period. (23) The apparatus according to embodiment 19, wherein the processor is further configured to prompt the user when the timing of the sample exhalation falls outside the predetermined period. (24) The apparatus according to Embodiment 19, wherein the processor is further configured to prompt the user with a modification suggestion if the timing of the sample exhalation falls outside the predetermined period, or if the intensity of the pressure does not change with respect to the ambient pressure, or if the pressure is negative. (25) A method for determining user sampling compliance, The user is instructed to exhale a sample breath into the sampling unit over a predetermined period of time, The sampling unit receives the exhaled breath through the exhaled breath sampling port defined on the sampling unit, Upon sensing the sample breath, the pressure change relative to the ambient pressure is measured via at least one pressure sensor located within the sampling unit and communicating with the breath sampling port. The timing of the pressure change supplied to the at least one pressure sensor by the sample breath is measured via a processor that communicates with the at least one pressure sensor, The timing of the sample exhalation is compared with the predetermined period, A method comprising comparing the intensity of the pressure change with the ambient pressure.

[0074] (26) The method of Embodiment 25, further comprising instructing the user to hold their breath for at least 10 seconds before instructing the user to exhale the sample breath. (27) The method according to embodiment 25, wherein prompting the user to exhale by instruction includes prompting the user to exhale the sample breath for at least 6 to 12 seconds. (28) The method according to embodiment 25, further comprising prompting the user if the pressure sensor detects a negative pressure change during the predetermined period. (29) The method according to embodiment 25, further comprising prompting the user if the timing of the sample exhalation falls outside the predetermined period. (30) The method according to Embodiment 25, further comprising prompting the user with a modification suggestion if the timing of the sample exhalation falls outside the predetermined period, or if the intensity of the pressure does not change with respect to the ambient pressure, or if the pressure is negative.

[0075] (31) A device configured to determine user sampling compliance, A sampling unit having an exhalation sampling port, A first pressure sensor is provided, which is in communication with the primary flow path within the sampling unit and is arranged to be in fluid communication with the exhaled breath sampling port. A second pressure sensor is provided, which is in communication with the secondary flow path within the sampling unit and is arranged to be in fluid communication with the exhalation sampling port and one or more ventilation openings. A device comprising: a processor that communicates with the first pressure sensor and the second pressure sensor, the processor being configured to acquire a first pressure measurement from the first pressure sensor, acquire a second pressure measurement from the second pressure sensor, and determine the pressure ratio of the second pressure measurement to the first pressure measurement. (32) The apparatus according to embodiment 31, wherein the processor is further configured to prompt the user by instruction to exhale a sample breath into the exhalation sampling port over a predetermined period of time. (33) The apparatus according to embodiment 32, wherein the processor is further configured to measure a pressure change relative to ambient pressure when it senses the sample exhaled breath. (34) The apparatus according to embodiment 33, wherein the processor is further configured to measure the timing of the pressure change provided by the sample breath. (35) The apparatus according to embodiment 34, wherein the processor is further configured to compare the timing of the sample exhalation with the predetermined period and to further compare the intensity of the pressure change with the ambient pressure.

[0076] (36) The apparatus according to Embodiment 31, wherein the processor is further configured to compare a subsequent pressure ratio obtained from a subsequent breath sample measurement with the pressure ratio, and as a result, a deviation of the subsequent pressure ratio from the pressure ratio indicates that one or more vent openings are blocked. (37) The apparatus according to embodiment 36, wherein the processor is further configured to prompt the user with a correction suggestion when the deviation is detected. (38) A method for determining user sampling compliance, The sampling unit receives exhaled sample through a defined sampling port, a first portion of the exhaled sample flows into a primary channel, a second portion of the exhaled sample flows into a secondary channel, and passes through one or more ventilation openings. To acquire a first pressure measurement value via the first pressure sensor in the primary flow path, A second pressure measurement is obtained via a second pressure sensor in the secondary flow path, The pressure ratio of the second pressure measurement to the first pressure measurement is determined via a processor that communicates with the first pressure sensor and the second pressure sensor, A method for determining the deviation, comprising comparing the pressure ratio with a subsequent pressure ratio obtained from a subsequent breath sample measurement. (39) The method according to embodiment 38, further comprising prompting the user by instruction to exhale a sample breath into the breath sampling port over a predetermined period of time before receiving the sample breath. (40) The method according to embodiment 39, further comprising sensing the sample exhaled breath and measuring the pressure change relative to the ambient pressure.

[0077] (41) The method according to embodiment 40, further comprising measuring the timing of the pressure change provided by the sample exhaled breath. (42) The method according to embodiment 41, further comprising comparing the timing of the sample exhalation with the predetermined period, and further comparing the intensity of the pressure change with the ambient pressure. (43) The method according to embodiment 38, further comprising prompting the user with a correction suggestion when the deviation is detected.

Claims

1. A device configured to determine user-defined sampling compliance, A sampling unit having an exhalation sampling port, A first pressure sensor is provided, which is configured to communicate with the primary flow path within the sampling unit and to have fluid communication with the exhalation sampling port. A second pressure sensor is provided, which is in communication with the secondary flow path within the sampling unit and is arranged to be in fluid communication with the exhalation sampling port and one or more ventilation openings. A device comprising: a processor that communicates with the first pressure sensor and the second pressure sensor, wherein the processor is configured to acquire a first pressure measurement value from the first pressure sensor, acquire a second pressure measurement value from the second pressure sensor, and determine the pressure ratio of the second pressure measurement value to the first pressure measurement value.

2. The apparatus according to claim 1, wherein the processor is further configured to prompt the user by instruction to exhale a sample breath into the exhalation sampling port over a predetermined period of time.

3. The apparatus according to claim 2, wherein the processor is further configured to measure a pressure change relative to ambient pressure when it senses the sample breath, the processor is further configured to measure the timing of the pressure change given by the sample breath, the processor is further configured to compare the timing of the sample breath with a predetermined period of time, and further to compare the intensity of the pressure change with the ambient pressure.

4. The apparatus according to claim 1, wherein the processor is further configured to compare a subsequent pressure ratio obtained from a subsequent breath sample measurement with the pressure ratio, and as a result, a deviation of the subsequent pressure ratio from the pressure ratio indicates that one or more vent openings are blocked, and the processor is further configured to prompt the user with a correction suggestion when the deviation is detected.

5. A method for determining user sampling compliance, The sampling unit receives exhaled sample through a defined sampling port, a first portion of the exhaled sample flows into a primary channel, a second portion of the exhaled sample flows into a secondary channel, and passes through one or more ventilation openings. To acquire a first pressure measurement value via the first pressure sensor in the primary flow path, A second pressure measurement is obtained via a second pressure sensor in the secondary flow path, The pressure ratio of the second pressure measurement to the first pressure measurement is determined via a processor that communicates with the first pressure sensor and the second pressure sensor. A method for determining the deviation, comprising comparing the pressure ratio with a subsequent pressure ratio obtained from a subsequent breath sample measurement.

6. The method according to claim 5, further comprising prompting the user by instruction to exhale the sample breath into the sampling port for a predetermined period of time before receiving the sample breath.

7. The method according to claim 6, further comprising sensing the sample exhaled breath, measuring the pressure change relative to the ambient pressure, measuring the timing of the pressure change provided by the sample exhaled breath, comparing the timing of the sample exhaled breath with the predetermined period, and further comparing the intensity of the pressure change with the ambient pressure.

8. The method according to claim 5, further comprising prompting the user with a correction suggestion when the aforementioned deviation is detected.

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