Biological sample device, analysis software and method

Abstract

Disclosed herein is a biological sample device comprising a body comprising an inlet that is connectable to a mask configured to capture a breath sample from an animal; a first outlet, arranged to allow the breath of the animal to exit the device; and a second outlet, arranged to allow the breath of the animal to flow into a collection chamber. The device also comprises an electrically operated valve, the valve being arranged to direct the breath of the animal to the first outlet and operable to divert the breath of the animal to the second outlet; a pressure sensor located within the body, the pressure sensor being configured to sense a beginning and an end of an exhalation of the animal; and a microcontroller configured to receive data from the pressure sensor and, based on an accumulation of these data, determine a breath collection period for the animal. The microcontroller is configured to operate the valve to divert the breath of the animal to the second outlet during the breath collection period of a subsequent exhalation of the animal.

Description

[0001]

[0002] The present technology relates to a biological sample device. In some embodiments, the device is associated with a capturing device and includes analysis software. In one embodiment, the invention relates to a device capable of capturing and analysing a breath sample from an animal, such as a cow, pig or sheep.

[0003] Background

[0004] It is known that biological samples from animals can yield a vast amount of information about the animal. For example, the blood of an animal carries certain chemical compounds and other substances (such as molecules or fragments of compounds of biological origin) which can be separated from the blood and analysed to determine the presence or absence of any one of a number of medical conditions, from disease and deficiency, through to specific biological conditions, such as pregnancy.

[0005] It is also known that some of the compounds found in bodily fluids such as blood are capable of crossing the lung barrier and traces of the compounds may be present in the exhaled breath of an animal. The presence and / or amount of the relevant compound or compounds present in the analysis of a chemical sample of an animal's breath can be used to determine the presence or absence of any one of a number of medical conditions. For example, one known technology which is applied to humans is the use of "breathalysers", which are well known examples of chemical reaction based or electronic devices that include a chemical or electronic sensor that, when presented with a sample of a person's breath, detects the blood alcohol level of the person.

[0006] One of the advantages of using breath as a biological sample is that taking the sample is not invasive and is therefore less traumatic to the animal, while potentially yielding faster results than a blood analysis.

[0007] However, the collection of a breath sample from an animal is not an easy task. Unlike a human, it is difficult or impossible to provide any meaningful instruction to an animal. For example, it is not possible to instruct an animal to breathe out on command. Moreover, when faced with an unusual or unknown situation, such as having a device placed over the face, mouth or nostrils, the animal may react to a perceived threat of danger, by pulling away, struggling, holding their breath, etc., which may result in the breath sample being contaminated by ambient air or not being of a sufficient volume to allow for accurate analysis.

[0008] It is with at least some of these issues in mind that the present invention has been developed. In the context of the specification, the term "breath sample" encompasses any captured mixture of gas and liquid exhaled from the lungs of an animal.

[0009] In the proceeding description, the acronym VOC refers to Volatile Organic Compounds (as found in the exhaled breath of an animal) and the term CO2 refers to the compound carbon dioxide, a component of exhaled breath from all animals.

[0010] In a first aspect, the present invention provides a biological sample device comprising a body comprising: an inlet that is connectable to a mask configured to capture a breath sample from an animal; a first outlet, arranged to allow the breath of the animal to exit the device; and a second outlet, arranged to allow the breath of the animal to flow into a collection chamber; an electrically operated valve, the valve being arranged to direct the breath of the animal to the first outlet and operable to divert the breath of the animal to the second outlet; a pressure sensor located within the body, the pressure sensor being configured to sense a beginning and an end of an exhalation of the animal; and a microcontroller configured to receive data from the pressure sensor and, based on an accumulation of these data, determine a breath collection period for the animal, wherein the microcontroller is configured to operate the valve to divert the breath of the animal to the second outlet during the breath collection period of a subsequent exhalation of the animal.

[0011] Advantageously, the device of the present invention is adapted to collect the portion of the animal's exhalation most likely to contain the highest concentration of the VOCs that are indicative of a medical condition to be determined, e.g. pregnancy. The device predicts, based on the animal's prior exhalations, when to start taking the sample and when to finish taking the sample. A higher concentration of VOCs in the breath sample can be assumed to improve the sensitivity and specificity of the diagnostic algorithm.

[0012] In one embodiment, the breath collection period may include breath from end tidal CO2 of the exhalation. In one embodiment, the microcontroller may be configured to operate the valve to divert the breath of the animal to the second outlet only after two consecutive exhalations have approximately the same duration. The breath collection period may, for example, last for about half of the duration of the subsequent exhalation, and begins at a time after the start of the subsequent exhalation that is determined from the duration of the two prior exhalations.

[0013] In one embodiment, the pressure sensor may be a gauge pressure sensor, located between the inlet and the first outlet and perpendicular to the flow of breath therebetween.

[0014] In one embodiment, the collection chamber may be a flexible bag arranged to connect to the second outlet.

[0015] In one embodiment, the device may further comprise a CO2 sensor. The CO2 sensor may, for example, be located in the collection chamber. The CO2 sensor may, for example, be operable to determine whether a concentration of CO2 in the collected breath is above a predetermined threshold (e.g. between about 3.6 to 4.2%, or above about 4%). Concentrations of CO2 above this threshold are indicative of alveoli breath, likely to be rich in VOCs.

[0016] In one embodiment, the collection chamber may comprise a sensor assembly capable of measuring the presence of at least one compound contained in the breath sample to provide an electrical signal indicative of the presence of the at least one compound. In alternative embodiments, such a sensor array may be provided in a separate unit, such as an eNose unit, configured to receive the breath sample, e.g. from the flexible bag referred to above.

[0017] In one embodiment, the device may further comprise a one-way valve configured to prevent the breath sample which flows into the collection chamber from exiting the chamber.

[0018] In one embodiment, the device may further comprise a networking module capable of sending data associated with the breath sample to a remote computing system or device.

[0019] In one embodiment, the device may further comprise a RFID sensor, arranged to collect information from the animal associated with the breath sample.

[0020] In a first aspect, the present invention provides a method for predicting a breath sampling period that includes end tidal CO2 during an exhalation of an animal, the method comprising: determining a volume of dead space within the conducting airways of the animal; determining a duration and a volume of a plurality of prior exhalations of the animal; determining a delay period following the start of an exhalation to be sampled, whereby breath exhaled from the dead space is excluded from the breath sampling period; and determining a collection time that commences after the delay period and concludes before a predicted finish of the exhalation.

[0021] In one embodiment, the sampling period finishes substantially at end tidal CO2.

[0022] In one embodiment, determining a duration of a plurality of prior exhalations of the animal may comprise timing the duration of the exhalations. In one embodiment, determining a volume of a plurality of prior exhalations of the animal may comprise measuring their volume or estimating their volume based on the type of animal.

[0023] In one embodiment, determining the delay period may comprise subtracting an estimated volume of the dead space based on the type of animal from the total exhalation volume and estimating the time taken to exhale that volume based on a calculated average exhalation rate for the animal.

[0024] In one embodiment, the exhalation to be sampled follows two prior consecutive exhalations having a similar duration (e.g. within 25% of each other).

[0025] In one embodiment, determining the length of the collection time may comprise estimating the duration of the previous exhalation based on the duration of the previous exhalation.

[0026] In one embodiment, the method may further comprise measuring a level of CO2 in the collected breath sample to confirm it is above a threshold value.

[0027] The present invention also provides a system including the biological sample device of the first aspect for collecting a VOC-rich breath sample and a sensor (e.g. an eNose sensor) configured to sense the presence of the VOCs.

[0028] Also disclosed herein is a biological sample analysis device comprising a body including an inlet connectable to a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal and an outlet arranged to allow the breath of the animal to exit the device, an electrically operated diverter valve located within the body and positioned between the inlet and outlet, and a sensor located in a sample chamber located within the body of the device, the sample chamber also being in selective communication with the diverter valve, the chamber further including a sensor assembly capable of measuring the presence of at least one compound contained in the breath sample to provide an electrical signal indicative of the presence of the at least one compound to a microcontroller, wherein the microcontroller is arranged, upon determining the relative concentration of the at least one compound in the breath sample, and if the relative concentration is a desired concentration, the microcontroller moves the valve to an open condition, to allow the breath sample to flow into the chamber.

[0029] Further features of the present invention are more fully described in the following description of several non-limiting embodiments thereof. This description is included solely for the purposes of exemplifying the present invention. It should not be understood as a restriction on the broad summary, disclosure or description of the invention as set out above. The description will be made with reference to the accompanying drawings in which:

[0030] Figure 1 is a diagram of a system architecture of a biological sample capture device in accordance with an embodiment of the invention;

[0031] Figure 2 is a diagram illustrating a system architecture of a biological sample capture device in accordance with an embodiment of the invention; Figure 2 (inset) shows the system architecture of the Sensor Assembly & Collection Bag of Figure 2.

[0032] Figure 3 is a diagram of a detailed system architecture of a biological sample capture device in accordance with an embodiment of the invention;

[0033] Figure 4 is a diagram of a detailed system architecture of a biological sample capture device in accordance with an embodiment of the invention;

[0034] Figure 5 depicts a biological sample capture device in accordance with an embodiment of the invention;

[0035] Figure 6 is an exploded view of a portion of the biological sample capture device of Figure 5;

[0036] Figure 7 depicts a portion of the biological sample capture device of Figure 5;

[0037] Figure 8 is an exploded view of a portion of a first part of the biological sample capture device of Figure 5;

[0038] Figure 9 is an exploded view of a portion of the biological sample capture device of Figure 5; and

[0039] Figure 10 is a perspective view of a diverter mechanism in the biological sample capture device of Figure 5.

[0040] Figure 11 is a capnogram of a breath cycle.

[0041] The primary aim of the present invention is to capture the portion of an animal's breath most likely to have the highest concentration of VOCs, notwithstanding the myriad of variables likely to be encountered in real world applications (e.g. pregnancy testing a heard of cows). As VOCs are used to determine pregnancy (and other medical conditions), a higher concentration of VOCs in a breath sample can be assumed to improve the sensitivity and specificity of the pregnancy determination algorithm.

[0042] 5

[0043] SUBSTITUTE SHEET (RULE 26) VOCs are exchanged between the lung alveolar and expired air. Therefore, it can be assumed that within a breath cycle, the concentration of CO2and VOC concentration are correlated. A breath cycle can be represented graphically in the form of a capnogram, such as that illustrated in Figure 11.

[0044] Phase I is the end of the animal's inhalation. Phase II is the beginning of the animal's exhalation and contains the breath from the animal's anatomical "dead space", including its conducting airways such as its trachea. Phase III is the CO2-rich breath originating from the alveoli of the animal's lungs and Phase IV is inspiratory downstroke, the beginning of the animal's next inspiration.

[0045] Phase III contains the highest CO2concentration. Using the assumption that CO2concentration is correlated with VOC concentration within a breath cycle, pre-concentration of VOCs in expired breath can be achieved through the capture of Phase III breath. Phase I and Phase II of the capnogram has a lower concentration of CO2as a large portion of expired air from these phases originates from the apparatus and conducting airways (e.g. trachea) and not from the high surface-volume ratio alveoli. Breath from these phases is therefore less likely to be rich in VOCs.

[0046] If the time durations of each of exhale phases could be determined, the inventor realised that an alternative method of capturing Phase III breath which doesn't require a capnograph can be developed. As t2 occurs within the breath cycle, assumptions are required to estimate t2. This estimation will be referred to as t2*. By determining the sources of dead space in an animal, the dead volume that is linked to Phase II of the capnogram is relatively predictable. For cattle, for example, the anatomical dead volume is related to bovine biology. One study measured the ratio of dead volume to tidal volume (VD / VT) as about 0.50, although factors such as bovine breeds, sex, age and weight will affect this ratio. Any dead volume associated with the sampling device of the present invention is insignificant compared to the animal's dead volume. Assuming the VD / VT as 0.50 then, t2* is a point halfway through the expiratory breath cycle by volume. Thus:

[0047] 6

[0048] SUBSTITUTE SHEET (RULE 26)

[0049] The times tl and t3 are relatively trivial to calculate and can be determined by detecting the start of exhalation, and the end of exhalation respectively.

[0050] With t2* and t3 known, the breath collection period (i.e. the decision to sample or discard breath) can be determined and used to produce a real-time implementation of a breath capture algorithm.

[0051] To calculate tl, t2* and t3, and selectively sample breath between t2* and t3, the breath sampling device is capable of (1) detecting at what times the subject begins and finishes exhaling for each breath cycle, as well as (2) controlling when to discard and when to sample breath.

[0052] The detect the former, gauge pressure sensors that are perpendicular to the inlet flow path in the sample device may be used to determine whether the animal is inhaling or exhaling.

[0053] To control the latter (i.e. (2)), the flow pathway is changed by the device when sampling and discarding breath by actuating a valve connected to a brushed DC motor. One unavoidable implication of such a design is the non-zero time taken to transition the flow path between the sampling and discarding states and, to account for this, a modification of the breath sampling algorithm is required to account for the valve movement time (which was roughly estimated to be between 100 to 130 ms).

[0054] As the breath sampling device of the present invention contains a pressure sensor in the flow inlet pathway, calculating the time at which exhalation starts and ends is relatively simple. When P(t) is greater than Patm, one can assume the animal is exhaling.

[0055] From these data, the algorithm driving the sample collection device can predict the likely duration of the next exhalation of the animal. As noted above, the calculation of t2* requires knowing what t3 is within the breath cycle. For a real-time implementation of the breath control algorithm, a prediction of t3 (t3*) will need to be determined. A simple method of doing this would be to assume the exhalation duration will be identical to the previous exhalation duration:

[0056] The calculation of t3* would then be: [n] =3[n - 1] - t - 1] + n]

[0057] However, the inventor has observed that bovine exhale duration becomes unsettled when in the presence of humans, and especially so in the stressful environment where breath samples are to be collected. The accuracy of t3* is highly dependent on the stability of the animal's breath and therefore, the predictability of breath. The inventor's extensive field trials have discovered that about 60% of exhalations are within about 25% of their previous exhalation duration. Thus, the inventor has discovered that that the current exhalation duration will likely be the same as previous exhalation duration, within a small margin of error. In effect, the two exhalations prior to the (third) exhalation to be sampled can be used to predict, with sufficient accuracy, the duration of the third exhalation (to within about 25%).

[0058] In the present invention, therefore, the device receives at least two consecutive breaths prior to it sampling the following (third) breath. The consistency of these two breaths actuates the sample collection operation for the third breath. In the event of the two breaths being of dissimilar duration (e.g. because the animal is highly stressed), then no sample will be taken until things have calmed down and a regular exhalation pattern established.

[0059] Whilst the invention is described herein primarily in the context of testing the breath of animals such as cows (e.g. to determine whether they are pregnant), the inventor notes that its applications are more wide ranging than this. For example, the device and method may be used on humans to detect some conditions (e.g. acetone in a human's breath may be indicative of diabetes).

[0060] In the following detailed description of Figures 1 to 10, like numerals across Figures 1 to 10 refer to like features and / or integers.

[0061] Referring to Figures 1 through 10, there are shown various diagrams illustrating the architecture and / or illustrations of a device capable of capturing and analysing biological samples. In one embodiment, the device is a breath capturing device capable of capturing the breath of an animal, for either "on the spot" (immediate) analysis or later analysis.

[0062] Broadly, the embodiment provides a biological sample device. The device comprises a body including an inlet connectable to a mask portion arranged to fit over the nostrils of an animal to capture a breath sample from the animal.

[0063] The device also includes a first outlet arranged to allow the breath of the animal to exit the device, a second outlet arranged to allow the breath of the animal to flow into a collection chamber and an electrically operated diverter valve located within the body and arranged to direct the breath of the animal to the first outlet and operable to divert the breath of the animal to the second outlet.

[0064] The device also includes a pressure sensor located within the body, the pressure sensor being configured to sense a beginning and an end of an exhalation of the animal, as well as a microcontroller configured to receive data from the pressure sensor and, based on an accumulation of these data, determine a breath collection period for the animal.

[0065] In use, the microcontroller is configured to operate the valve to divert the breath of the animal to the second outlet during the breath collection period of a subsequent exhalation of the animal.

[0066] OVERVIEW OF COMPONENTS OF EMBODIMENT

[0067] A broad overview of a system that includes a biological sample device is shown in Figure 1 and a more detailed overview of component parts of the system and device is shown in Figure 2. It will be understood that Figures 1 and 2 are abstract representations of the components of the device and the association between the components that make up the device.

[0068] The device 100 is utilised by a user 101 to take a breath sample from a livestock animal 103. The device 100 includes a mask portion 102 which is in fluid communication with a chamber and diverter arrangement 110 which in turn incorporates a sensor arrangement 170 which is described in more detail hereinbelow.

[0069] It will be understood that any sensor capable of detecting VOCs and CO2 to an accuracy required by the embodiment may be utilised as a suitable sensor, and the claimed invention should not be unduly narrowed to the use of one particular example of a suitable sensor, as would be understood by a person skilled in the art.

[0070] The device 100 is capable of communicating with a mobile computing device (or other computing device) 105 via Bluetooth capability. It will be understood that other embodiments may use WiFi, or any other known communication protocols, including "wired" protocols, as would be understood by a person skilled in the art. The device 100 also includes a rechargeable battery as a power source (not shown in Figure 1) and may be recharged via a charger 130.

[0071] In the embodiment, the biological sample is the breath of an animal. It will be understood that the device may be utilised to capture any type of animal breath, although in the example and Figures shown herein, the device is adapted to be particularly suited to capture the breath of a large farm animal, such as a cow, as the mask portion 102 (also termed a "funnel", "snout" or "nose cone") as shown in, for example, Figure 7, is arranged to provide a good fit over the nostril of an animal such as a cow. It will be understood that the mask portion 102 is removeable and interchangeable with different sizes and shapes of mask, so that different size mask portions can be utilised to best suit different animals.

[0072] The device includes a housing 104 comprised of two parts 104a and 104b (as shown in Figure 6), which in the embodiment described herein has a handle portion 106 for easy use by a person. The main body portion 108 of the device housing 104 houses the divertor arrangement 110, the sensor arrangement 170, and other components required to operate the divertor arrangement 110 and the sensor arrangement 170.

[0073] The device may be conceptually divided into a number of areas, which are described hereinbelow in an arbitrary order.

[0074] One area relates to the main logic control 120 of the device, which contains one or more microcontrollers and other circuitry designed to receive input from a user, from the animal, and provide an output reading to the user. The main logic control 120 is in connection with the sensor arrangement 170 which includes one or more sensors.

[0075] The logic control 120 is also in electrical connection with a number of subsidiary logic controls, including a logic circuit to manage charging of the battery 180, logic control 144 to control the buttons 140 and screen 142 on the device and logic control 148 to control the LEDs and the RFID reader integrated into the device.

[0076] The main logic control 120 also interfaces with a logic control 150 which operates the breath detection system 156 and logic control 152 which takes information from the valve position sensor.

[0077] The sensor arrangement 170 is in communication with an inlet 114 arranged to connect to the mask portion 102 and intermediate the inlet 114 and the outlet port 112 is a valve arrangement 126 arranged to either "hold" the sample in a chamber 156 within the device 100 for analysis, or alternatively vent the sample to the atmosphere.

[0078] The sensor arrangement 170 includes a sensor sub-array 122. A sample enters and is held in the sample port 154 for analysis by one way valve 164. There is provided a fresh air inlet port 161 , to allow air to pass through the sensor sub-array 122 when required and an exhaust port 160 to allow the collected sample to be vented once the measurement has taken place.

[0079] Referring to Figure 3 in particular, there is shown a diagram illustrating the main electrical connections between components (the circuitry) of the device 100. The circuitry of the device is based around the main logic control 120, which is connected to several subsidiary logic controls such as the pressure sensor logic control 150, the battery / charging logic control 180, the valve position logic control 152, and the display logic control 144. In turn, the display logic control 144 is connected to the display 142 and logic control 148 to control the LEDs 148 and RFID sensor. The battery / charging logic control 180 is connectable to the charger 130 and the battery pack 132.

[0080] The main logic control 120 also directly controls the motor 124, has connectivity hardware and software (such as Bluetooth) which allows the device to connect with a mobile device or other computing device 105 and also has a RFID antenna 192 to allow the device 100 to read data from livestock tags 190.

[0081] REMOTE AND CLOUD SERVICES AND CONNECTIVITY

[0082] Referring to Figure 4 in particular, there is shown the hardware and software components for a data collection and analysis system associated with and utilised by the device 100. The broader embodiment described herein is capable of networking and providing data to an external system such as a mobile device (e.g. a cell phone), a mobile computing system, a conventional computing system and / or a cloud server. In the embodiment shown, there is provided a cloud client service 300, operated by Agscent, which allows the device 100 to take in data such as the RFID tag details 190 of an animal, use data 310 from the sensor firmware and utilise the firmware 312 from the Agsent system to collate and send data to the mobile device 105 and particularly to the app 111. In turn, the mobile device 105 sends data to the Agscent web service 300 which includes two databases, an application database 302 and an authentication database 304, which interface with a web service application 306 and communicate with the app 111 via a web server 308.

[0083] In use, requests for access to specific applications and / or data are sent by the app 111 to the webserver 308, and utilising the web services layer 306, the request is first authenticated using data from authentication database 304, after which applications and data can be accessed from application database 302.

[0084] Applications may include analytical software arranged to analyse large data sets of previously collected data, access to upload or download past data, further analysis of breath samples (where more computing power is required to perform an analysis), the accessing of software updates for updating the app 111 or the firmware 310 and 312 of the device 100, or any other suitable purpose as may be required from time to time.

[0085] The Agscent web service 300 provides a way to extend the functionality of the device 100 while simultaneously allowing the device 100 to still perform the fundamental function of analysing a breath sample without the need for connection or access to remote services or computing. EXAMPLE EMBODIMENT

[0086] Referring to Figures 5 to 10 in particular, there are shown various illustrations of an embodiment of the invention. Referring to Figures 5 and 6, the device includes a housing 104 comprised of housing parts 104a and 104b. There is also provided a funnel 102 which is attachable to inlet port 114, a battery pack 132 and logic control 120, plus an exhaust port 112.

[0087] Referring to Figure 7, the logic control 120 includes a screen 142 located on a screen PCB 144, LED and RFID PCB 148 which includes a RFID antenna 192 and LEDs 146. The components of Figure 7 locate over the components of Figure 8. Namely, the logic control 120 of Figure 7 locates over the breath detection sensor PCB 150 which in turn locates over the diverter body 128.

[0088] Referring generally to Figures 8 to 10, the diverter body 191 is in fluid connection with an inlet port 114 and an exhaust port 112 and also another exhaust port 160. The diverter body also houses a diverter valve 126, sealed using rings 121 and 123. The diverter valve 126 is operated by a motor 124 and gears 195 and 199. The position of the diverter valve is determined by an optical sensor 194. A pressure sensor in the form of breath detection sensor 150 is disposed between the inlet port 114 and exhaust port 112.

[0089] The Internal diverter valve and flap in the embodiment shown are manufactured from a Taimans (brand name) t-glase PETT plastic, which is a commercially available plastic arranged to produce a very low level of "off gassing". Similarly, the surrounding housing of the embodiment is manufactured from Onyx (brand name) nylon blend with carbon fibre, again to reduce off gassing and to provide a robust mechanism that is more likely to survive and continue to operate in a harsh environment. It will be understood that any suitable materials may be utilised to construct the diverter system.

[0090] OPERATION OF EMBODIMENT

[0091] The sensor sub-assembly described herein functions as a measuring device which is specifically designed to capture breath samples from larger livestock animals such as cows, pigs and sheep. It will be understood, however, that the arrangement described herein may also be utilised, with minor variation in design, for any type of breath capture, including humans. Such variations are within the purview of a person skilled in the art.

[0092] In brief, the device allows a user to place the nose cone over a nostril of a livestock animal, allowing the animal to breathe in and out normally while autonomously capturing and analysing the breath of the animal and preventing the captured air from escaping either due to pressure differences or when the animal breathes in. The device is configured to divert a portion of the animal's exhaled breath towards the second outlet and hence the collection chamber, for subsequent analysis. In some embodiments, for example, the collection chamber may be provided in the form of a plastic bag, which is transported to a separate detection device (e.g. an eNose sensor for detecting the specific VOCs, or to a GC instrument if a more general analysis of the sample is required).

[0093] In other embodiments, a sensor arrangement may be provided inside the device, enabling a relatively instantaneous result. The sensor arrangement, if included, is in part based on an earlier version of the applicant's device, which is described in PCT / AU2021 / 051083, filed in the name of Agscent Pty Ltd on 20 September 2021 and entitled "BIOLOGICAL SAMPLE ANALYSIS DEVICE WITH ASSOCIATED CAPTURING DEVICE AND ANALYSIS SOFTWARE", which is incorporated herein by reference. In this device, a carbon dioxide sensor is used to control operation of a diverter, with the sample being collected once the CO2 level in the exhaled breath exceeded a threshold minimum. Whilst this device has enjoyed some commercial success, the inventor has sought to improve the reaction time of the diverter, resulting in a reimagination of the parameters that actuate the diverter.

[0094] As shown in Figure 2, the device 100 is capable of operating in a mode analogous to the applicant's earlier device, namely the diverting of a breath sample into a "collection bag" 109, for later analysis. The device may, however, also be configured to detect a wide range of VOCs and an equivalent of CO2 (eCCh) in situ, using a sensor sub-assembly arranged to produce a signal which is utilised by the device to determine the concentration levels of various VOCs and CO2 on the animals' breath. The analysis is performed within the device itself, although other embodiments allow for additional analysis to be performed externally of the device 100, as data is sent to the mobile device 105 to an app 111, which is capable of performing further analysis, with or without connection to the cloud.

[0095] As noted above, the inventor has found that CO2 levels are related to the relative length of breath, and that higher CO2 levels are consistent with the capture of a higher level of VOCs, which in turn allow for a high quality result when the captured breath is analysed for the presence of specific biomarkers (such as biomarkers that indicate pregnancy of the animal).

[0096] It will be understood that the "desired" level of CO2 concentration is determined by a number of factors, including the animal type, other environmental conditions, the relative sensitivity of the sensor and the analysis technique employed to determine the presence of biomarkers. Therefore, the relative amounts and concentrations provided in the present specification apply to a particular sensor subassembly and particular environmental conditions described with reference to the example embodiment described herein, and the app 111 allows a user to provide specific information, where available, about location, weather conditions, particular types or breeds of animals, and other information that may influence the accuracy of the result. The theory for using CO2 as an indicator of rich VOC is based on the biological rationale that high levels of CO2 is from alveolar breath which is air from the deepest part of the lungs. The applicant has progressed on the assumption that higher CO2 and VOC correlate. In other words, as CO2 increases, so does the richness of VOC in the breath sample. Therefore, based on experimental evidence described in the earlier filed PCT application PCT / AU2021 / 051083, it was found that there is a boundary effect that eliminates the lowest 20% of CO2 values. This provides a lower limit which is utilised to determine whether the sensor sub-assembly has received a suitable sample and therefore determine when the diverter (described below) operates.

[0097] Moreover, an upper limit is also determined as it is hypothesised that very high CO2 values may be due to CO2 produced from the gut of the animal, not from breath as such. Therefore, the device might, in some embodiments, be arranged to also exclude breath with very high CO2 levels (i.e. the diverter system excludes breaths with very high CO2 levels).

[0098] Returning specifically to Figures 9 to 11, an example of the diverter system, which incorporates the sensor arrangement described above is shown, in accordance with an embodiment of the invention.

[0099] The diverter system has an inlet and a number of outlets, and an electric motor which operates a diverter valve and is controlled by one or more microcontrollers located on the Main PCB and the subsidiary PCBs (Valve Position Sensor PCB and Breath Detection Sensor PCB) and arranged to divert the breath sample along one of multiple possible paths depending on an initial analysis. The one or more microcontrollers are provided with data either directly or indirectly via a sensor valve position sensor and a breath detection sensor. The Diverter system also includes a valve position sensor to receive information on the position of the valve.

[0100] The diverter (valve) system comprises an open-close valve system to divert concentrated breath samples from the animal to either a chamber for further analysis, to an outlet which is attachable to a collecting device (such as a collector bag) or vented to the external atmosphere.

[0101] It will be understood that, as previously described, the device also includes other components required for the operation of the device, including a power source such as a rechargeable battery. It will be further understood that the device may also include or interface with other known components, such as a means for charging the battery, a power switch, a reset button and other like controls.

[0102] In the embodiment shown, a visual and audible indicator means, comprising a screen and LEDs, is utilised to provide instruction and information to the user and correspondingly a user can easily operate the device without the requirement for specialist knowledge. EMBODIMENT IN USE

[0103] When used to capture and analyse a sample of breath "in situ", the device is placed against the nostril of a large animal, such as a cow, the nose piece is placed over the nose of the animal, and when the animal breathes out into the nose piece, the breath of the animal is monitored to establish the duration of the exhalations. Once stability in the animal's exhalations is achieved, as established by two consecutive breaths of similar duration, the algorithm determines the time to collect the breath having the requisite richness from the following exhalation. Until the sample time is started, the animal's breath is directed via diverter valve to the exhaust port and subsequently to the outside of the device, which acts as an exit valve for air that does not meet the CO2 / VOC requirements for rich sample data, while allowing the animal to breathe in and out comfortably.

[0104] Subsequently, when the algorithm indicates the start of the sample time (about half way through the predicted expiration), the motor repositions the diverter valve, redirecting the flow of air past the one way valve and into the sample port. This continues until the predicted end of the expiration, thus capturing the end tidal breath, which is rich in CO2 and VOCs. The one way valve stops the captured breath in the sample port from being inhaled once collected in the port. Once the port contains an adequate amount of gas, the gas is analysed by the sensor sub-assembly and information is provided to either screen on the device or to the app, via Bluetooth, to an associated mobile computing device.

[0105] When used simply to capture a sample of breath rather than provide an analysis "in situ", the device is placed against the nostril of a large animal, such as a cow, the nose piece is placed over the nose of the animal, and when the animal breathes out into the nose piece, the breath of the animal is monitored for the requisite richness and until the relevant richness is identified, breath is directed via the exhaust port to the outside of the device, which acts as an exit valve for air that does not meet the CO2 requirements for rich sample data, while allowing the animal to breathe in and out comfortably.

[0106] Advantages, industrial Applicability and Disclaimers

[0107] One of the advantages of the embodiments and broader invention described herein is that the device provides a cost effective, reliable and reusable device for capturing and analysing a breath sample to a required standard without the need to capture the breath sample for a more detailed analysis of the volatile organic compounds contained in the breath sample at a separate location.

[0108] Moreover, in one embodiment, the automation of the diverter allows a user to easily collect and analyse a breath sample that is of a desired standard or quality from an animal without requiring any specific training, understanding of the underlying working principles of the device, or requiring the user to have any specialist knowledge of any "rules" or specific procedures for determining the standard or quality of the breath sample. The specification refers to the use of "logic controls". The term "logic controls" is utilised to denote any suitable mixture of microcontrollers, electronic circuitry, integrated circuits, processors, or combinations thereof required to carry out the functions required. In other words, the term "logic control" is to be read broadly to cover any appropriate component or arrangement of components.

[0109] The specification refers to the entity "Agscent", which is shorthand for "Agscent Pty Ltd", an Australian private company which developed and owns the technology and embodiments described and defined herein at the time the specification was filed. It will be noted that use of the name "Agscent" is provided solely for context and as a convenient descriptor of origin and ownership, and no gloss is to be taken from reference to Agscent to limit the meaning of any technical terms in this specification.

[0110] Throughout this specification, unless the context requires otherwise, the word "comprise" or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated integer or group of integers but not the explicit exclusion of any other integer or group of integers.

[0111] Those skilled in the art will appreciate that the embodiments described herein are susceptible to obvious variations and modifications other than those specifically described and it is intended that the broadest claims cover all such variations and modifications. Those skilled in the art will also understand that the inventive concept that underpins the broadest claims may include any number of the steps, features, and concepts referred to or indicated in the specification, either individually or collectively, and any and all combinations of any two or more of the steps or features may constitute an invention.

[0112] Where definitions for selected terms used herein are explicitly provided within the detailed description of the invention, it is intended that such definitions apply to the claimed invention. However, if not explicitly defined, all scientific and technical terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which the invention belongs.

[0113] Related applications

[0114] This application claims priority from Australian provisional patent application no. 2023902428, the contents of which are hereby incorporated in their entirety.

Claims

1. A biological sample device comprising a body comprising: an inlet that is connectable to a mask configured to capture a breath sample from an animal; a first outlet, arranged to allow the breath of the animal to exit the device; and a second outlet, arranged to allow the breath of the animal to flow into a collection chamber; an electrically operated valve, the valve being arranged to direct the breath of the animal to the first outlet and operable to divert the breath of the animal to the second outlet; a pressure sensor located within the body, the pressure sensor being configured to sense a beginning and an end of an exhalation of the animal; and a microcontroller configured to receive data from the pressure sensor and, based on an accumulation of these data, determine a breath collection period for the animal, wherein the microcontroller is configured to operate the valve to divert the breath of the animal to the second outlet during the breath collection period of a subsequent exhalation of the animal.

2. The device of claim 1, wherein the breath collection period includes breath from end tidal CO2 of the exhalation.

3. The device of claim 1 or claim 2, wherein the microcontroller is configured to operate the valve to divert the breath of the animal to the second outlet only after two consecutive exhalations have approximately the same duration.

4. The device of claim 3, wherein the breath collection period lasts for about half of the duration of the subsequent exhalation, and begins at a time after the start of the subsequent exhalation that is determined from the duration of the two prior exhalations.

5. The device of any one of claims 1 to 4, wherein the pressure sensor is a gauge pressure sensor, located between the inlet and the first outlet and perpendicular to the flow of breath therebetween.

6. The device of any one of claims 1 to 5, wherein the collection chamber is a flexible bag arranged to connect to the second outlet.

7. The device of any one of claims 1 to 6, further comprising a CO2sensor.

8. The device of claim 7 , wherein the CO2sensor is located in the collection chamber.

9. The device of claim 7 or claim 8, wherein the CO2sensor is operable to determine whether a concentration of CO2in the collected breath is above a predetermined threshold.

10. The device of claim 9, wherein the CO2concentration is above 4%.

11. The device of any one of claims 1 to 10, wherein the collection chamber comprises a sensor assembly capable of measuring the presence of at least one compound contained in the breath sample to provide an electrical signal indicative of the presence of the at least one compound.

12. The device of any one of claims 1 to 11, further comprising a one-way valve configured to prevent the breath sample which flows into the collection chamber from exiting the chamber.

13. The device of any one of claims 1 to 12, further comprising a networking module capable of sending data associated with the breath sample to a remote computing system or device.

14. The device of any one of claims 1 to 13, further comprising a RFID sensor, arranged to collect information from the animal associated with the breath sample.

15. A method for predicting a breath sampling period that includes end tidal CO2during an exhalation of an animal, the method comprising: determining a volume of dead space within the conducting airways of the animal; determining a duration and a volume of a plurality of prior exhalations of the animal; determining a delay period following the start of an exhalation to be sampled, whereby breath exhaled from the dead space is excluded from the breath sampling period; and determining a collection time that commences after the delay period and concludes before a predicted finish of the exhalation.

16. The method of claim 15, wherein the sampling period finishes substantially at end tidal CO2.

17. The method of claim 15 or claim 16, wherein determining a duration of a plurality of prior exhalations of the animal comprises timing the duration of the exhalations.

18. The method of any one of claims 15 to 17, wherein determining a volume of a plurality of prior exhalations of the animal comprises measuring their volume or estimating their volume based on the type of animal.

19. The method of any one of claims 15 to 18, wherein determining the delay period comprises subtracting an estimated volume of the dead space based on the type of animal from the total exhalation volume and estimating the time taken to exhale that volume based on a calculated average exhalation rate for the animal.

20. The method of any one of claims 15 to 19, wherein the exhalation to be sampled follows two prior consecutive exhalations having a similar duration.

21. The method of claim 20, wherein the duration of the two prior consecutive exhalations is within 25% of each other.

22. The method of claim 20 or claim 21, wherein determining the length of the collection time comprises estimating the duration of the previous exhalation based on the duration of the previous exhalation.

23. The method of any one of claims 15 to 22, further comprising measuring a level of CO2 in the collected breath sample to confirm it is above a threshold value.

Images