Patent Description:
Breath sampling is a promising technique for facilitating non-invasive diagnosis and health monitoring. Volatile organic compounds (VOCs) are present in breath, which result from both metabolic processes in the cells of the body and from the microbiome inhabiting the body. These metabolic processes may be affected/disrupted by disease conditions, resulting in changes in the VOC profile present in breath. It is therefore possible to identify disease conditions by analysis of VOC profiles in sampled breath. Changes in VOC profile may provide biomarkers that enable specific disease conditions to be identified. This is a promising and active area of research.

Obstacles to widespread adoption of breath sampling as a diagnostic technique include sampling methodology. Different methodologies for breath sampling lead to significant variation in data obtained from subsequent analysis of the samples. Increasing availability of a high quality breath sampling methodology would stimulate development of breath sampling as a diagnostic technique.

An example of an existing breath sampling device is disclosed in <CIT>. <CIT> discloses a breath testing apparatus, mouthpiece, collection chamber and discharge chute. A breath sample may be collected within the collection chamber and transferred to an evacuated container through the discharge chute by a sample transfer assembly A further prior art device is known from <CIT>.

It is challenging to obtain a breath sample that facilitates reliable analysis of VOC compounds in breath. The VOC mass present in a typical breath sample is low, and precise analysis of the VOC profile can easily be confounded by contaminants in the breath sample. It is also desirable that a breath sampler is easy to use and maintain, and affordable enough to deploy at scale.

Although considerable progress in breath sampling has been made, there is room for improvement in a number of areas.

A device in accordance with the invention is defined in claim <NUM>.

According to a first aspect, there is provided a device for obtaining a breath sample from a patient, comprising:.

Drawing the sample into the sample container (e.g. a thermal desorption tube, needle trap, arrow sampler or solid phase microextraction fibre) through a sampler may confer advantages in certain embodiments. In some embodiments, the sampler may be configured to approximate isokinetic sampling, thereby reducing contamination of the analytical signature of the breath sample (for example due to collection of water and aerosols). In some embodiments, the sampler may reduce contact with the sample container during assembly and disassembly of the sample container in the breath sampling device.

The sampler opening may be disposed in a sidewall of the distal portion. In certain embodiments this may better approximate isokinetic sampling conditions.

The sampler opening may be spaced apart from a tip of the distal portion. A tip of the distal portion may comprise an end flange. In certain embodiments this may help prevent contact with the sampler opening and/or improve approximation of isokinetic sampling conditions.

The distal portion of the sampler may be substantially tube shaped (e.g. cylindrical). The sampler may comprise a proximal portion configured to engage with the sample container.

The proximal portion of the sampler may be configured to seal against the outside of the sample container.

The sampler may comprise an internal groove and an O-ring seal disposed in the internal groove for forming a seal with the outside of the sample container.

The sample container is removeable from the breath sampling device by pulling on the sampler. In certain embodiments this enables the sample container to be handled during installation and removal in the breath sampling device via the sampler, thereby avoiding contact with the sample container.

The device may comprise a filter, downstream of the sampler (such as a HEPA filter). This may avoid or reduce the potential for particles (e.g. virus particles) in the patient's breath from exiting the breath sampling device.

The device further comprises a handle for holding the device. The sample container and sampler are housed by the handle The sampler is configured for sealing engagement with the handle.

The sampler may comprise an external groove and an O-ring seal disposed in the external groove for forming a seal with the handle.

The handle may comprise a hand operable clip for locking and unlocking engagement of the handle with the mask or mouthpiece.

The handle may comprise an inner sleeve and an outer sleeve, and the handle may be securable to the mask or mouthpiece by clamping the mask or mouthpiece between the inner and outer sleeve.

The filter may be received by the inner sleeve (e.g. by a push fit).

The handle may comprise a pressure probe for communicating a fluid pressure to a pressure sensor.

The handle may comprise an intake air conduit, for providing to the mask or mouthpiece for the patient to breath.

According to a second aspect, there is provided an air purifier for a breath sampling device, the air purifier comprising at least one cartridge filter (which may be cylindrical) configured to purify air provided to the breath sampling device.

The cartridge filters may be standard cartridge filters (e.g. NATO <NUM> standard gas filters such as an AX filter cartridge). In certain embodiments, the use of (commercially available) cartridge filters may reduce the cost associated with using and servicing the air purifier.

According to a third aspect, there is provided a breath sampling system, comprising the device according to the first aspect, and the air purifying system according to the second aspect.

The air purifier may comprise two cartridge filters, configured for parallel flow.

The air purifier may comprise three (or more) cartridge filters, which may be configured for parallel flow. More cartridge filters in parallel may provide for enhanced flow rate and improved air purification by removal of volatile organic compounds.

The air purifier may comprise a hand operated latch for obtaining access to the cartridge filters for replacement of the cartridge filters.

According to a fourth aspect, there is provided a system for transportation of breath sampling consumables, comprising:.

In certain embodiments, this may avoid time consuming sealing procedures for sample containers which are commonly employed in prior art breath sampling methodologies (e.g. involving the use of tools etc).

The first cap socket and second cap socket may be configured to allow a thermal desorption tube, capped by a first and second end cap, to be rotated from a first upstanding position in which the first end cap is received in the first cap socket, to a second prone position in which the second end cap is clipped into the second cap socket.

According to a fifth aspect, there is provided a system for breath sampling, comprising a breath sampling device according to the first aspect, an air purifier according to the second aspect, and a controller configured to control flow of a breath sample through the sample container.

The controller may comprise a sampling port for connection to the sample container and a pressure port for connection to the pressure probe. The controller may comprise a sampling pump for drawing air through the sampling port, and therefore through the sample container. The controller may comprise a pressure sensor for detecting pressure in the breath sampling device via the pressure port. The controller may comprise control logic for controlling the operation of the breath sampling device. The control logic may be configured to control the sampling pump, responsive to the pressure sensor.

According to a sixth aspect, there is provided a method of sampling breath of a patient for analysis, comprising:.

The breath sampling device may be in accordance with the first aspect. The method according to the sixth aspect may comprise using any of the breath sampler, air purifier and breath sampling system features described herein.

The method may comprise providing a purified supply of air to the breath sampling device for the patient to breathe. The supply of purified air may be used to maintain a positive pressure in the mask or mouthpiece.

According to a seventh aspect, there is provided a breath sampling system comprising:.

The device for obtaining a breath sample may further comprise an outlet through which breath is exhausted from the device. The outlet may be situated on the mask or mouthpiece.

The device for obtaining a breath sample may be in accordance with the first aspect.

The breath sampling system may further comprise an air purifier configured to provide air to the mask or mouthpiece. The air purifier may comprise at least one cartridge filter (which may be cylindrical) configured to purify air provided to the mask or mouthpiece.

The air purifier may be in accordance with the second aspect.

The mask or mouthpiece may be fluidly coupled to the air purifier by a flexible tube.

The air purifier and controller may be housed in a container or housing.

The mode selection valve may be housed in a container or housing.

The air purifier, controller and mode selection valve may be housed in the same container or housing. Other components of the breath sampling system may also be housed in the same container or housing. The container or housing may allow for easier transportation of the breath sampling system.

The housing or container may be a briefcase. In some embodiments components of the breath sampling system may be operable without being removed from the housing or container. For example, the controller, air purifier and mode selection valve may be controlled while housed in the container or housing. This may allow for faster set up or easier operation of the system.

The container or housing further may comprise a holding fixture configured to hold the device for obtaining a breathing sample. In some embodiments the container or housing may be a briefcase, and the holding fixture may be a holder on the internal surface of the lid of the briefcase. The holding fixture may make operation of the system more convenient for the user by providing a stowage point for the mask or mouthpiece while the user performs other tasks. This may also prevent the mask or mouthpiece being placed on an unsanitized surface.

The controller may be configured to connect wirelessly with a remote computer.

The remote computer may be a mobile computing device. The mobile computing device may be, for example, a smartphone.

The mobile device may comprise software for controlling the controller and/or the air purifier. The software may be an app that is installed on a smartphone.

The app may be an app configured to run on an iOS and/or Android smartphone. In some embodiments, the app may allow the user to control the controller and/or air purifier. A user input on the app may be used to control the controller and/or air purifier as required to obtain an environmental sample, a control sample or a breath sample from a patient.

In some embodiments the app may be configured to generate and/or record additional information in relation to samples obtained using the breath sampling system. For example, the user may instruct the controller to obtain an environmental sample, a control sample or a breath sample from a patient using a user input on the app. The app may then record a log regarding the sample. The log may include for example: time and date information of the sample (which may be provided by the smartphone operating system); additional information about the sample regarding the user inputs entered on the app before the sample was obtained (for example sample type); additional information entered manually on the app by the user (for example notes regarding user observations).

The app may generate a reference code that may be used to associate logs on the app with samples taken using the breath sampling system. The reference code may be an alphanumeric sequence that the user writes on the sample after the sample is obtained and correspondingly logged in the app. In some embodiments each sample may have an identification marker (such as a QR code, barcode or alphanumerical sequence) that may be scanned using the app and a camera on the smartphone to find any logs corresponding to each sample.

In some embodiments the app may provide the user with instructions or information regarding the operation of the breath sampling system. For example, the app may provide the user with sequential instructions that guide the user through obtaining an environmental sample, a control sample and then a breath sample with the breath sampling system. Such instructions and information may be provided by the app in a number of languages, selectable by the user.

According to an eighth aspect, there is provided a method for sampling breath of a patient with a breath sampling system, comprising:.

The breath sampling system may be in accordance with the seventh aspect.

The environmental sample may be taken using a port to sample ambient air and the control sample and breath sample may be taken using a sample conduit connected to a mask or mouthpiece of the device for obtaining a breath sample from a patient,.

The method may comprise:
after obtaining the environmental sample and before obtaining the control sample, moving a selection valve from a first position wherein a sample pump is fluidly coupled to the port to sample ambient air to a second position wherein the sampler pump is connected to the sample conduit connected to the mask or mouthpiece.

The method may comprise providing a purified supply of air to the mask or mouthpiece for the patient to breathe. The purified air supply may be provided by an air supply connected to an air purifier. The air supply may be turned on and off as required. The supply may be used to maintain a positive pressure in the mask or mouthpiece.

The method may comprise obtaining the control sample while the device for obtaining a breath sample is stowed in a holding fixture of a container or housing of the breath sampling system.

The method may comprise:
after obtaining the control sample and before obtaining the breath sample from the patient, removing the device for obtaining a breath sample from the holding fixture and fitting the device onto a patient.

The method may comprise using a mobile computing device to at least partially instruct the breath sampling system to obtain at least one of the samples in response to a user input.

The mobile computing device is a smartphone and the user input involves pressing a button in an app, wherein pressing the button instructs the breath sampling system to obtain one of the samples.

The app may be in accordance with the seventh aspect.

Embodiments of the invention will described, purely by way of example, with reference to the accompanying drawings, in which:.

Referring to <FIG>, an example device <NUM> for obtaining a breath sample from a patient is shown, comprising a mask <NUM>, a handle <NUM>, a sampler <NUM> and a sample container <NUM> for receiving a breath sample.

The mask <NUM> may comprise a flexible material, and is configured to conform to the contours of the patient's face. The mask <NUM> may be disposable consumable item, replaced for each new patient to be sampled. The mask <NUM> is detachable from the handle <NUM>, by using a hand operated clip <NUM> (without the use of tools), which will be described in more detail below.

In use, the patient places the mask <NUM> over their face, and breathes into the device <NUM>. The breath is received by the mask <NUM> and channelled into the handle <NUM>. The breath is exhausted from the handle via the outlet <NUM>, which comprises a one-way valve. Air is received into the handle <NUM> via an intake conduit <NUM> for the patient to breath in through the mask <NUM>. Optionally, the interior of the mask <NUM> and handle <NUM> may be maintained at positive pressure by a pumped flow of air received by the intake conduit <NUM>. The inflowing air may be purified (e.g. to reduce background contaminants in the breath that do not arise from the patient).

The handle <NUM> houses the sample container <NUM>, which receives a breath sample from the flow of breath into the mask <NUM>. The sample container <NUM> in this example is preferably a thermal desorption tube <NUM>, but in other embodiments different types of sample container (suitable for sampling VOCs) may be used, including a needle trap, arrow sampler or solid phase microextraction fibre. The sample container <NUM> may be configured to retain VOCs compounds in breath by reversible adsorption. Subsequent heating of the sample container <NUM> will release (by desorption) the VOCs for analysis (e.g. using gas chromatography with mass spectrometry detection or GC-MS).

In order to reliably characterise the trace VOCs that are collected in the sample container <NUM>, for example to perform a diagnosis based on biomarkers, it is important that contamination of the sample is avoided. In prior art devices, such contamination has typically been hard to avoid. The applicant has identified that a source of contamination can arise from handling of the sample container <NUM>. Even gloved hands may load the sample container with contaminants on handling, and these contaminants may, in certain cases, confound or obscure accurate profiling of VOC compounds in the breath sample. Certain embodiments of the present device are therefore arranged to minimise contact with the sample container <NUM> during installation of the sample container <NUM> in the device <NUM> and during removal of the sample container <NUM> from the device <NUM> (after breath sampling).

A proximal portion of the sampler <NUM> is configured to engage with the sample container <NUM> by receiving a portion of the sample container <NUM> in a recess in the sampler <NUM>. The sampler <NUM> is provided with a seal <NUM> that engages with an internal surface of the sampler <NUM> and an external surface of the sample container <NUM>. In this embodiment the seal <NUM> comprises an o-ring <NUM>, retained in an internal groove in the sampler <NUM>.

When the sample container <NUM> is received in sealing engagement with the sampler <NUM>, the sample container <NUM> can be picked up by holding the sampler <NUM>. The sample container <NUM> can consequently be handled by holding the sampler <NUM> rather than the sample container <NUM>, for example to place the sample container <NUM> in the device <NUM> and to remove the sample container from the device <NUM>. Placing the sample container <NUM> in the device may comprise first assembling the sample container <NUM> in sealing engagement with the sampler <NUM>, then placing the assembled sample container <NUM> and sampler <NUM> in the device <NUM>. The sample container <NUM> is received in a sample container housing <NUM>. The sample container housing is at an acute angle to the direction of breath flow <NUM> from the mask <NUM> to the outlet <NUM> (which may make isokinetic sampling more straightforward to achieve).

The sampler <NUM> engages with the handle <NUM> when installed in the device <NUM>. An external o-ring <NUM> is retained in an external groove <NUM> of the sampler <NUM> for forming a seal between the handle <NUM> and the sampler <NUM>. In the example embodiment, the sampler <NUM> seals against an inner sleeve <NUM> of the handle.

The sampler <NUM> comprises a sampler opening <NUM> and an internal channel for communicating a breath sample from the sampler opening <NUM> to the interior of the engaged sample container <NUM>. A sample conduit <NUM> is connected to the sample container housing <NUM> to draw a breath sample into the sample container <NUM> (for instance by the application of a negative pressure to the sample conduit <NUM>).

A further problem in prior art breath sampling devices arises from the velocity of sample flow in the sampling path not being well matched with the velocity of breath through the sampling device. Under such conditions aerosol and condensate droplets may be entrained with the sample. A more representative sample can be obtained when the sampling conditions better approximate the isokinetic sampling condition, in which there is no divergence or convergence of flow lines around the sample inlet.

The applicant has identified that, in certain embodiments, more representative samples may be obtained from a sampler opening <NUM> that is in a sidewall of the sampler <NUM>, as shown, for example, in <FIG>. In certain embodiments, the sampler <NUM> may be provided with a locator (such as a radial protrusion) so that the rotational orientation of the sampler <NUM> in engagement with the handle <NUM> is defined, thereby defining the orientation of the sampler opening <NUM> with respect to the flow of breath through the handle <NUM>. The preferred orientation of the sampler opening <NUM> may be facing perpendicular to the flow direction of breath through the handle <NUM>, as shown in <FIG>. The sampler opening <NUM> may be arranged to be located substantially in a central region of the breath flow path from the mask <NUM> to the outlet <NUM>.

The sampler opening <NUM> is spaced apart from a tip of the sampler <NUM>, so that the sampler <NUM> can easily be handled without contact with the sampler opening <NUM>. This helps reduce contamination of any breath samples through handling. An end flange <NUM> is provided at the distal tip of the sampler <NUM>, which further helps reduce the potential for contact with the sampler opening <NUM> by providing purchase for gripping and removing the sampler <NUM> and sample container <NUM>.

The handle <NUM> comprises an inner sleeve <NUM> and an outer sleeve <NUM>. The inner sleeve <NUM> is cylindrical and concentric with the outer sleeve <NUM>. The inner sleeve <NUM> comprises a latch <NUM> which is resiliently biased outwards. The outer sleeve <NUM> comprises an opening that is configured to receive a portion of the latch. As the inner sleeve <NUM> is pushed into the outer sleeve, the latch <NUM> engages with the outer sleeve <NUM> to lock the inner sleeve <NUM> in position. The mask <NUM> is clamped between a flange <NUM> of the inner sleeve <NUM> and the outer sleeve <NUM> when the inner sleeve <NUM> is locked in position. The inner sleeve <NUM> can be detached from the outer sleeve <NUM> by pinching the latch on either side of the handle with one hand, thereby facilitating separation of the inner sleeve <NUM> from the handle <NUM>, and the mask or mouthpiece from the handle <NUM>. Removal of the sampler <NUM> and sample container <NUM> does not require that the inner sleeve <NUM> is disengaged from the handle <NUM>.

A filter <NUM> may be provided between the mask <NUM> and the outlet <NUM>, preferably downstream of the sampler <NUM>. In the example embodiment, a filter <NUM> is provided that is received in a recess in the inner sleeve <NUM>. The filter <NUM> may, for example, comprise a HEPA filter. This may easily be replaced (without using tools) by detaching the inner sleeve <NUM> from the handle, as described above.

In order to facilitate control of sampling of breath at appropriate times in a breathing cycle of the patient (e.g. by controlling a pump connected to the sample conduit <NUM>) a pressure sensing probe <NUM> is provided, for communicating the pressure in the handle to a pressure sensor (via the pressure conduit <NUM>), which may be in a controller external to the breath sampling device. Separating control systems from the breath sampler may decrease the cost of ownership and use of the sampling system as a whole, since the breath sampling device can readily be broken down and cleaned/sterilised for re-use, and the controller remains free from potential contact with the patient and contamination. The breath sampling device <NUM> may be free from electronics and sensors.

Referring to <FIG>, a system <NUM> is shown, comprising the breath sampling device <NUM> shown in <FIG>, and further comprising an intake conduit <NUM> connecting the breath sampling device <NUM> to an air purifier <NUM>. The pressure conduit <NUM> and sample conduit <NUM> exit the intake conduit <NUM> before the air purifier <NUM>, for connection to a control system. Such a control system may include a microprocessor, pump and pressure sensor, and may be configured to control sampling of breath.

The air purifier <NUM> receives air (e.g. from an air pump, <NUM> in <FIG>), and removes any background contaminants (including VOCs), which enables improved detection of biomarkers in breath samples (by removing background contaminants).

The air purifier <NUM> is shown in more detail in <FIG>, and comprises an intake manifold <NUM>, outlet manifold <NUM>, first filter cartridge <NUM>, second filter cartridge <NUM>, and housing <NUM>.

The intake manifold <NUM> comprises an inlet <NUM> by which air is provided (e.g. from an air pump) to the air purifier <NUM>. The air is provided from the intake manifold <NUM> to the first and second filter cartridge <NUM>, <NUM>, which are configured in a parallel configuration. The first and second filter cartridge may comprise standard filter cartridges (e.g. conforming with EN14387A1 and/or meeting the requirements of European Directive <NUM>/<NUM> EEC, such as the Moldex A1 or a compatible cartridge). The first and second filter cartridge <NUM>, <NUM> may therefore be relatively low cost and straightforward to replace (in contrast with prior art proprietary air purification systems, which are typically very expensive to service).

The outlet manifold <NUM> receives purified air from the first and second cartridges <NUM>, <NUM>, and provides this to the intake conduit <NUM>, which supplies the breath sampling device <NUM> with purified air. The pressure conduit <NUM> and sample conduit <NUM> exit the intake conduit <NUM> adjacent to the outlet manifold <NUM>, for connection to a control system.

The intake manifold <NUM> and the outlet manifold <NUM> are clipped to the housing <NUM>. The outlet manifold is clipped to the housing <NUM> with a rotating cam lock system <NUM>, facilitating straightforward removal of the outlet manifold <NUM> for replacement of the filter cartridges <NUM>, <NUM>.

<FIG> shows an example air purification system <NUM> similar to that shown in <FIG>. The left-hand side of the figure shows the air purification system <NUM> comprising outlet manifold <NUM>, intake manifold <NUM>, intake conduit <NUM> and housing <NUM>. The right-hand side of the figure shows the air purification system <NUM> with the outlet manifold <NUM> illustrated transparently for clarity. The air purification system is configured to house three cartridge filters connected by the outlet manifold <NUM> and intake manifold <NUM> for parallel flow (although only two cartridges are shown in this figure). Three cartridges may provide higher flow rate and improved filtration of volatile organic compounds as compared to systems with two cartridges. In <FIG> the outlet manifold <NUM> is coupled to the housing <NUM> and the inlet manifold <NUM> using fasteners such as screws. Co-axial holes <NUM> are provided in the outlet manifold <NUM>, housing <NUM> and inlet manifold <NUM> for receiving such fasteners. Alternatively, an arrangement more like that of <FIG> may be used.

<FIG> illustrates the effectiveness of an air purification system according to an embodiment (similar to that shown in <FIG>), showing a count per scan (inverted) for a prior art breath sampling air purification system <NUM> and for an air purifier <NUM> in accordance with an embodiment. The level of contaminants present in the purified air is substantially lower for the air purifier according to an embodiment.

<FIG> show a system <NUM> for transportation of breath sampling consumables, comprising an insulated case (with a base <NUM> and lid <NUM>), tray <NUM>, pivotable cap sockets <NUM>, fixed cap sockets <NUM> and coolant vessel <NUM>. The consumables for storage comprise at least one of: sample containers <NUM>, samplers <NUM>, non-transient machine readable instructions <NUM> (e.g. a user manual for a breath sampling device or system, or instructions for configuring a computer to control a breath sampling system) for example on a USB drive, mask <NUM>, mouthpiece <NUM>, human readable instructions <NUM>, <NUM>.

The system <NUM> is configured to enable a sample container <NUM> to be sealed and engaged with the tray <NUM> with the minimum of contact with the sample container <NUM>. For example, the tray <NUM> includes slots for sample containers <NUM> that are engaged with a sampler <NUM>. A sample container cap <NUM> may be placed in a pivotable socket <NUM>, and the exposed end of the sample container <NUM> inserted into the end cap (while holding the sampler <NUM>). A sampler cap <NUM> may subsequently be placed over the sampler <NUM> to seal the sampler opening <NUM>. The sample container <NUM> and sampler <NUM> may then be pivoted (as indicated by arrow <NUM> in <FIG>) so that the sampler cap <NUM> is received and retained in place by a fixed socket defined in the tray <NUM>.

Alternatively, the sampler <NUM> may be removed from the sample container <NUM>, and sample container caps <NUM> used to seal each end of the sample container <NUM>. One of the tube caps <NUM> may again be received in a pivotable socket <NUM>, and then the sample container <NUM> pivoted to engage the other end cap with a stationary socket <NUM>. This system makes it straightforward to cap the sample containers <NUM> with the minimum of effort, and with minimal contact and hence reduced risk of contamination of the sample.

In order to ensure that VOCs are retained within the sample containers <NUM> and remain stable during transit, a coolant bag may be provided in the system to maintain a low temperature in the interior of the insulated case. The coolant bag may, for example, contain a suitable phase change material such as water or sodium polyacrylate.

<FIG> shows a breath sampling system comprising: a breath sampling device <NUM>, air purifier <NUM>, air pump <NUM> and controller <NUM>. The breath sampling device <NUM> may, for example, be as shown in <FIG>, and the air purifier may be as shown in <FIG> and/or <NUM>. The air pump <NUM> is connectable to the air purifier <NUM> to pump air through the air purifier <NUM> for supply to the breath sampling device <NUM>. A positive pressure may thereby be maintained in the breath sampling device <NUM> while it is in place on a patient's face. A controller <NUM> is provided, comprising a sampling pump, pressure sensor and control logic (such as a microprocessor). The controller <NUM> comprises a sampling port and a pressure port, respectively for connection to the sample conduit <NUM> and the pressure conduit <NUM>. The controller may be configured to pump a sample of breath into the sample container during a particular, preselected, portion of the patient's breathing cycle. For example the end tidal portion of a breath cycle may be targeted for sampling, based on a variation in pressure detected by the pressure sensor via the pressure conduit <NUM>.

<FIG> shows an alternative breath sampling system (BreathTrace) similar to that of <FIG>. As in <FIG>, the breath sampling system comprises: a breath sampling device, an air purifier, air pump and controller. The breath sampling system of <FIG> further comprises a quality control system <NUM>. A thermal desorption tube can be positioned in the port of the quality control system <NUM>. The quality control system <NUM> includes a valve that is connected to the controller. This enables the collection of environmental samples or system blank samples with the system.

<FIG> and <FIG> illustrate example results obtained by GC-MS analysis of samples obtained in accordance with an embodiment <NUM>, compared with results obtained using a market leading existing breath sampling device <NUM>. The results <NUM> from the prior art breath sampling device include contamination from collected water, which may interact with active phases in thermal desorption traps and stationary phases in a gas chromatography column to produce cyclic siloxanes. This may lead to the continuous and irreversible process of hydrolysis and degradation of analytical components, leading to variations in retention time and separation of features that may be useful as biomarkers. The variation complicates data modelling and reduces the likelihood of discovery of and effectiveness and accuracy of potential biomarkers. The sampler <NUM> provides more isokinetic sampling, which reduces the amount of water collected, and protects the sample container <NUM> from contact with the operator, reducing the potential for VOCs associated with gloves to be included in the analysed sample. This improvement can clearly be seen in comparing the results <NUM>, <NUM>. The results obtained from the market leading prior art device include contaminant features C that are associated with water retention in the collected breath samples, which is avoided in certain embodiments.

<FIG> shows a breath sampling system <NUM> similar to that of <FIG>. As shown in this example, the breath sampling system may be housed in one container or housing such as a briefcase <NUM>. In other examples, the housing may take other forms, such as a box with a removable lid. The left-hand side figure shows the example system <NUM> as it would be presented during operation, with the lid of the briefcase <NUM> open. The right hand-side figure shows the system <NUM> with the face plate <NUM> removed, exposing the internals of the system <NUM> contained in the lower half of the briefcase <NUM>.

When not removed, the face plate <NUM> is secured to the briefcase using screws <NUM>. In other embodiments the internal face plate may be secured with other mechanisms, for example rotating cam locks or latches. The face plate <NUM> of <FIG> is configured to allow operation of the system <NUM> while in place. The face place <NUM> comprises an air supply intake <NUM>. The internal face plate is configured to allow the user to operate the sample pump controls <NUM>, a selector dial <NUM> and the air supply on/off button <NUM>.

In the example of <FIG>, the internal face plate <NUM> is further configured to allow a conduit joint <NUM> to pass through the face plate <NUM>. The conduit joint <NUM> fluidly couples the air purifier <NUM> and intake conduit <NUM>. The conduit joint <NUM> may be decoupled from the air purifier <NUM> when the face plate <NUM> is removed. In some embodiments, the conduit joint <NUM> may be attached with a twist locking mechanism or a thread screw.

The housing <NUM> or face plate <NUM> may be configured to hold the handle of the device to obtain a breath sample <NUM> or mask <NUM>, when the housing <NUM> is closed or open. The face plate of figure comprises indents in which the handle <NUM> and mask <NUM> can be stored. In addition, the lid of the briefcase <NUM> comprises a holding fixture <NUM>. This may be used to hold the handle <NUM> and mask <NUM> while they are connected during operation.

Under the face plate <NUM> the briefcase <NUM> also houses the air supply <NUM> and sample pump <NUM>. Removing the face plate <NUM> also allows the user to access the air filter <NUM> locking mechanism <NUM>, if for example a filter cartridge needs replacing, or the air supply battery release button <NUM>.

The system <NUM> may also include a pump charging connector <NUM> and a USB laptop connector <NUM>, which can be accessed through the housing <NUM>.

According to an embodiment, the selector dial <NUM> is configured to operate a mode selection valve. In one example, the selector dial <NUM> has two positions, corresponding to two operating modes of the mode selection valve. In the first position, the selection valve fluidly couples the sample pump <NUM> with a port in order to sample ambient air. A sample container may be inserted into the port for obtaining an ambient air sample. In the second position the mode selection valve fluidly couples the sample pump with a sample conduit situated inside the intake conduit <NUM>, so that a sample of the patient's breath may be obtained in a sample container. Such a selector dial <NUM> and mode selection valve allows the example system to take ambient or environmental samples and samples of the patient's breath.

<FIG> shows an example method <NUM> of using a breath sampling system (for example the system shown in <FIG>) to obtain breath samples.

The breath sample collection method <NUM> of <FIG> comprises the following stages:.

At the beginning of the control test <NUM>, the mask <NUM> may be attached to the handle of the device to obtain a breath sample <NUM>. The mask <NUM> may be removed from handle at the end of the breath test <NUM>. During the control test <NUM> the mask <NUM> and handle <NUM> may be stowed in the handle fixture <NUM>.

In some examples, the samples may be taken: an environmental sample <NUM>; a control sample <NUM>; and a breath sample <NUM>. Samples may be collected in contains such as thermal desorption tubes. The containers may comprise a cap <NUM> and a sampler head <NUM>. The head <NUM> may be attached to the tube or container with a groove <NUM>.

Claim 1:
A device (<NUM>) for obtaining a breath sample from a patient, comprising:
a mask or mouthpiece (<NUM>) for receiving breath from a patient;
an outlet (<NUM>) through which breath is exhausted from the device (<NUM>);
a sampler (<NUM>), comprising:
a distal portion configured to protrude into a flow of breath from the mask or mouthpiece (<NUM>),
a sampler opening (<NUM>) in the distal portion for obtaining a breath sample; and
a sample container (<NUM>) suitable for sampling volatile organic compounds in communication with the sampler (<NUM>) for receiving the breath sample from the sampler (<NUM>);
a handle (<NUM>) for holding the device (<NUM>),
wherein the sample container (<NUM>) and sampler (<NUM>) are housed by the handle (<NUM>) and the sample container (<NUM>) is removeable from the breath sampling device (<NUM>) by pulling on the sampler (<NUM>).