Mouthpiece module for an exhaled breath sample collection device

Abstract

A mouthpiece module 300 for an exhaled breath sample collection device, comprises a housing component 200 with a housing aperture 204, and an inner component 100. The inner component comprises an inle

Description

TECHNICAL FIELD

[0001] The invention relates to a mouthpiece module for an exhaled breath sample collection device. The invention further relates to an exhaled breath sample collection device. BACKGROUND

[0002] Exhaled breath typically contains a mixture of different components, which can give an indication of airway disease and Physiology for a subject. The physical process of condensation allows capture of these components by passing exhaled breath directly through or over a collection surface at a lower temperature, to initiate condensing of the exhaled droplets and their constituent parts. The exhaled breath condensate remains on the collection vessel surface, whilst any exhaled breath remaining in suspension in air can continue past the collection surface and disperses in the environment.

[0003] The collected exhaled breath sample is susceptible to contamination when air from the external environment can freely flow into a collection vessel or over the collection surface. This may occur when a collection vessel or surface is detached from an exhaled breath collection assembly and e.g. a separate sealing cap is only applied to the collection vessel after removal from the assembly: between removal of the collection vessel and application of the sealing cap, the collection vessel is open to the air. In this situation, contaminants may enter the collection vessel, possibly distorting the results of any subsequent analysis.

[0004] WO2017153755A1 discusses a kit of parts for an exhaled breath condensate collection device including a mouthpiece module and a collection vessel. The collection vessel defines a sealed and resealable chamber for collecting exhaled breath condensate in use. The chamber is unsealed as the collection vessel is inserted into the device into a sample collection configuration, and the collection vessel is resealed as the collection vessel is removed from the device into a sample containment configuration. The collection vessel is caused to be resealed by the device into the sample containment configuration after sample collection and before the collection vessel is fully removed from the device in order to contain the breath sample and substantially prevent contamination of the breath sample.

[0005] Known devices for collecting a breath sample can be difficult to manipulate. Specialist training may be required for clinicians, or other users, to use the device to collect a breath sample. Yet further, specialist laboratory equipment may be required to remove a collection vessel containing the breath sample from an exhaled breath sample collection device without introducing contaminants into the collection vessel.

[0006] It is an aim of the present invention to address one or more of the disadvantages associated with the prior art. SUMMARY OF THE INVENTION

[0007] Aspects and embodiments of the invention provide a mouthpiece module for an exhaled breath sample collection device and an exhaled breath sample collection device.

[0008] According to a first aspect of the present invention, there is provided a mouthpiece module for an exhaled breath sample collection device. The mouthpiece module includes a mouthpiece inner component having a mouthpiece breath inlet port and a mouthpiece breath outlet port. The mouthpiece inner component defines a breath passageway between the mouthpiece breath inlet port and the mouthpiece breath outlet port. The mouthpiece module also includes a mouthpiece housing component having a housing aperture. The mouthpiece inner component is received within the mouthpiece housing component and is moveable between a retracted configuration and a breath collection configuration. In the retracted configuration the mouthpiece breath outlet port is retracted and positioned within the mouthpiece housing component. In the breath collection configuration, the mouthpiece breath outlet port permits exhaled breath to flow from the mouthpiece breath inlet port through the breath passageway and out of the mouthpiece housing component via the mouthpiece breath outlet port, in use. At least a part of an outer surface of the mouthpiece inner component is spaced apart from an inner surface of the mouthpiece housing component in both the retracted configuration and the breath collection configuration such that a fluid is free to flow around the mouthpiece inner component as the mouthpiece inner component moves between the retracted configuration and the breath collection configuration.

[0009] According to a second aspect of the present invention there is provided an exhaled breath sample collection device. The exhaled breath sample collection device includes the mouthpiece module and a collection vessel. The mouthpiece module includes a mouthpiece inner component having a mouthpiece breath inlet port and a mouthpiece breath outlet port. The mouthpiece inner component defines a breath passageway between the mouthpiece breath inlet port and the mouthpiece breath outlet port. The mouthpiece module also includes a mouthpiece housing component having a housing aperture. The mouthpiece inner component is received within the mouthpiece housing component and is moveable between a retracted configuration and a breath collection configuration. In the retracted configuration the mouthpiece breath outlet port is retracted and positioned within the mouthpiece housing component. In the breath collection configuration, the mouthpiece breath outlet port permits exhaled breath to flow from the mouthpiece breath inlet port through the breath passageway and out of the mouthpiece housing component via the mouthpiece breath outlet port, in use. At least a part of an outer surface of the mouthpiece inner component is spaced apart from an inner surface of the mouthpiece housing component in both the retracted configuration and the breath collection configuration such that fluid is free to flow around the mouthpiece inner component as the mouthpiece inner component moves between the retracted configuration and the breath collection configuration. The collection vessel defines a chamber for collecting an exhaled breath sample, in use. The collection vessel includes a vessel breath inlet for admitting exhaled breath into the chamber. In the breath collection configuration, the mouthpiece breath outlet port is coupled to the vessel breath inlet to permit exhaled breath to flow from the mouthpiece breath inlet port into the chamber of the collection vessel via the breath passageway, the mouthpiece breath outlet port and the vessel breath inlet.

[0010] In examples, the exhaled breath sample may include exhaled breath condensate. In examples the exhaled breath sample may comprise volatile compounds in the exhaled breath. In some examples, the breath sample may comprise exhaled breath condensate and volatile compounds in the exhaled breath. Here, exhaled breath condensate includes liquid and solid phase material. Exhaled breath condensate may include solid material in dry form, potentially partially hydrated form, or potentially encapsulated by droplets, and might remain suspended in air within the exhaled breath collection vessel, or become attached to a surface, for example a surface of the collection vessel, in either liquid or solid phase, depending on the temperature of the condensing surface of the collection vessel and the air contained therein. The condensate is produced by condensation of the exhaled breath within the collection vessel causing a phase change of at least a portion of the gases in the exhaled breath to liquid or solid phase. The condensate may comprise any matter contained within the liquid or solid phase material. The condensation of the exhaled breath may occur as a result of cooling the exhaled breath. The condensate may also contain ultrafine-to-large droplets from the exhaled breath. Volatile compounds may include volatile gases, for example the products of natural, physiological, or pathological chemical and biochemical processes, including those of commensal and infectious microorganisms within the body, that partition into the gas phase within the respiratory tract prior to exhalation by a subject.

[0011] In other examples the exhaled breath sample may include exhaled matter in a gaseous phase.

[0012] In examples, at least a portion of the mouthpiece inner component may not be flush with the mouthpiece housing component. Accordingly, fluid is free to flow between the mouthpiece inner component and the mouthpiece housing component. In examples, the mouthpiece inner component may be shaped and sized such that fluid is free to flow around the outer surface of the mouthpiece inner component within the mouthpiece housing component. In examples, an intermediate space having a volume may be defined between the mouthpiece inner component and the mouthpiece housing component. The volume of the intermediate space may be fixed, i.e. the volume does not change, when the mouthpiece inner component moves between the retracted configuration and the breath collection configuration. Alternatively, the volume of the intermediate space may vary. The intermediate space may be defined between the outer surface of the mouthpiece inner component and the inner surface of the mouthpiece housing component. In some examples, the intermediate space may be provided at least between a first side of the mouthpiece inner component and a first sidewall of the mouthpiece housing component such that the fluid is free to flow from below the mouthpiece inner component to above the mouthpiece inner component via the intermediate space. In some examples, the intermediate space may further be provided at least between a second side of the mouthpiece inner component and a second sidewall of the mouthpiece housing component. This advantageously allows fluid in the intermediate space to flow around the mouthpiece inner component as the mouthpiece inner component moves between the retracted configuration and the breath collection configuration.

[0013] The outer surface of the mouthpiece inner component being spaced apart from the inner surface of the mouthpiece housing component allows for improved manipulation of the mouthpiece inner component between the retracted configuration and the breath collection configuration. Fluid is free to flow from below the mouthpiece inner component to above the mouthpiece inner component as it is moved from the retracted configuration to the breath collection configuration. Likewise, the fluid is free to flow from above the mouthpiece inner component to below the mouthpiece inner component as it moves from the breath collection configuration to the retracted configuration. Accordingly, this provides a turbulent flow of fluid around the mouthpiece inner component within the mouthpiece housing component as the mouthpiece inner component moves between the retracted configuration and the breath collection configuration. As such, the pressure between the mouthpiece inner component and the mouthpiece housing component is equalised as the mouthpiece inner component moves between the retracted and breath collection configurations. This allows for easier movement of the mouthpiece inner component between the retracted configuration and the breath collection configuration.

[0014] In examples, the mouthpiece housing component may be formed from a rigid material. Accordingly, the volume of the intermediate space will be fixed. In other examples, at least a portion of the mouthpiece housing component may be formed from a semi-rigid material. In yet other examples, at least a portion of the mouthpiece housing component may be formed from a flexible material. Accordingly, the volume of the intermediate space may vary.

[0015] In examples, the fluid may be air.

[0016] In examples, the mouthpiece inner component may comprise a first portion and a second portion. The first portion may be a first housing portion or a first shell. The second portion may be a second housing portion or a second shell. The first portion may be coupled to the second portion to form the mouthpiece inner component. The first portion may be coupled to the second portion by any suitable coupling means. The first portion may be mounted to the second portion. In some examples, the first portion may be coupled to the second portion by one or more fasteners. In other examples, the first portion may be coupled to the second portion by an adhesive, for example, a pressure sensitive adhesive. In yet other examples, the first portion may be coupled to the second portion by welding. For example, the first portion may be couple to the second portion by ultrasonic welding or heat welding. The first portion may be coupled to the second portion by any suitable means. In some examples, the first portion may be coupled to the second portion such that the first portion and the second portion are sealed so as to prevent fluid ingress into, or egress from, the mouthpiece inner component. Advantageously, by connecting the first portion to the second portion, a contiguously or continuously sealed mouthpiece inner component may be formed, thereby reducing any leakage of saliva in the exhaled breath out of the mouthpiece inner component into other areas of the exhaled breath sample device, for example, into the mouthpiece housing component and / or the collection vessel, and so resulting in reduced contamination of the breath sample.

[0017] In other examples, the mouthpiece inner component may comprise a single body. In some examples, the mouthpiece inner component may be manufactured as a single body by a 3D printing or additive manufacturing.

[0018] In examples, the mouthpiece inner component may be manufactured as a multiplicity of parts. In examples, the mouthpiece housing component may be manufactured as a multiplicity of parts.

[0019] In examples, when in the breath collection configuration, the mouthpiece breath outlet port may protrude through the housing aperture to permit exhaled breath to flow from the mouthpiece breath inlet port through the breath passageway and out of the mouthpiece housing component via the mouthpiece breath outlet port, in use.

[0020] In examples, when in the breath collection configuration, the mouthpiece breath outlet port may be configured to fluidly connect with a collection vessel to permit exhaled breath to flow from the mouthpiece inlet port through the breath passageway and into the collection vessel. In some examples, when in the breath collection configuration, the mouthpiece breath outlet port may be configured to fluidly connect with a vessel breath inlet of the collection vessel to permit exhaled breath to flow from the mouthpiece inlet port through the breath passageway and into the collection vessel via the vessel breath inlet. In other examples, when in the breath collection configuration, the vessel breath inlet may protrude through the housing aperture and into the mouthpiece housing component to fluidly connect with the mouthpiece breath outlet port of the mouthpiece inner component to permit exhaled breath to flow from the mouthpiece inlet port through the breath passageway and into the collection vessel. In some examples, when in the breath collection configuration, the mouthpiece breath outlet port may be configured to connect with a vessel breath inlet of the collection vessel.

[0021] In examples, the mouthpiece housing component may comprise an inlet aperture, wherein the mouthpiece breath inlet port protrudes through the inlet aperture, and wherein the outer surface of the mouthpiece inner component covers the inlet aperture surrounding the mouthpiece breath inlet port in both the retracted configuration and the breath collection configuration. Advantageously fluid is substantially blocked from flowing into, and out of, the mouthpiece housing component through the inlet aperture and into the space between the mouthpiece inner component and the mouthpiece housing component. This at least substantially prevents contaminants from the external environment from being introduced into the mouthpiece housing module, thereby preventing contamination of the exhaled breath sample, which would otherwise result in an inaccurate representation of the exhaled breath sample.

[0022] In examples, the mouthpiece inner component may be slidably received within the mouthpiece housing component. The mouthpiece inner component may be slidable between the retracted configuration and the breath collection configuration.

[0023] In examples, the mouthpiece module may further comprise a seal configured to prevent fluid from flowing into the breath passageway through the mouthpiece breath inlet port when not in use.

[0024] In some examples, the seal may be a removeable cap. The removeable cap may be placed over the mouthpiece breath inlet port to prevent fluid from flowing into the breath passageway. The seal may be any other suitable means for preventing fluid from flowing into the breath passageway. For example, the seal may be a one way valve or a valve that can be opened and closed by a subject, clinician, or another user.

[0025] Advantageously, the seal prevents contaminants from the external environment from entering of the breath passageway when the exhaled breath sample collection device is not in use.

[0026] In examples, the mouthpiece module may also include a breath collection interface configured to be fluidly connected to the mouthpiece breath inlet port of the mouthpiece inner component.

[0027] In examples, the breath collection interface may be a mask. The mask may be suitable for covering the mouth and nose of a subject. Advantageously, the use of a mask for directing exhaled breath into the mouthpiece module reduces the amount of saliva in the subject’s exhaled breath, thereby providing a better quality breath sample.

[0028] In some examples, the mask may comprise a first protrusion and a second protrusion. Each of the first and second protrusion may be configured to apply pressure to a nose of the subject to prevent breath from being exhaled through the nose. In some examples, the protrusions may be integrally formed with the mask. In some examples, the protrusions may be sized and positioned to apply pressure to the subject's nose to prevent breath from being exhaled through the nose.

[0029] Advantageously, the protrusions applying pressure to the nose of the subject prevents the subject from blowing out of their nose when the mask is in use. This allows for the exhaled breath to only be directed from the subject's mouth. The inventors have found that a breath sample collected from the subject's mouth when the nose is blocked provides, the amount of saliva in the exhaled breath is reduced, thereby providing a better quality breath sample.

[0030] In some examples, the mask may include one or more air apertures to permit air flow into and out of the mask when it is positioned against a subject's face. In examples, the one or more apertures may comprise a one way valve configured to permit air to flow through the air apertures into the mask and to prevent exhaled breath from flowing out of the mask. In some examples, the one way valve may be an umbrella valve.

[0031] Advantageously, the one way valve allows the subject to inhale, drawing air from the external environment towards their nose and / or mouth. The one way valve also directs all the exhaled breath into the mouthpiece breath inlet port and prevents exhaled breath from escaping into the external environment. This ensures all of the exhaled breath flows from the mask into the mouthpiece module and / or the exhaled breath sample collection device, thereby improving the quality of the collected breath samples.

[0032] In examples, the one or more air apertures may comprise an air filter to filter air from the external environment as it enters the mask. In some examples, the air filter may be comprise a pre-defined pore size so as to at least substantially prevent unwanted airborne particle ingress without impacting inhalation flow rates. In examples, the mask may comprise a first aperture comprising a first air filter. In some examples, the first aperture may further comprise a first one way valve. In some examples, the mask may comprise a second aperture comprising a second air filter. In some examples, the second aperture may further comprise a second one way valve. Advantageously, the air filter filters inhaled air from the external environment so as to reduce, or prevent, the ingress of contaminants such as microorganisms, aerosols, pollutants and / or volatile compounds into the mask and consequently reduce, or prevent, microorganisms, aerosols, pollutants and / or volatile compounds from being inhaled, and subsequently exhaled, by the subject. The air filter may further prevent potentially infectious agents found in breath, such as virus particles, fungi, bacteria or other microorganisms, from escaping into the environment.

[0033] In examples, the mask may be configured to be detachably connected to the mouthpiece breath inlet port.

[0034] In examples, the breath collection interface may be integrally formed with the mouthpiece breath inlet port. Advantageously, the mouthpiece module does not require assembly by a subject, clinician, or another user.

[0035] In other examples, the mouthpiece breath inlet port may define a breath collection interface. Advantageously, the subject may blow directly into the mouthpiece breath inlet port of the mouthpiece inner component.

[0036] In examples, the mouthpiece inner component may include a saliva trap in the breath passageway between the mouthpiece breath inlet port and the mouthpiece breath outlet port. Advantageously, this traps any saliva in the exhaled breath, thereby preventing saliva from entering the chamber of the collection vessel or at least reducing the amount of saliva entering the chamber of the collection vessel.

[0037] In examples, the mouthpiece inner component may also include an actuation protrusion protruding through an actuation aperture of the mouthpiece housing component to permit the mouthpiece inner component to be moved between the retracted configuration and the breath collection configuration. The mouthpiece module may be configured to be user-operable to cause the movement of the mouthpiece inner component between the retracted and breath collection configurations. The actuation protrusion may be a user operated flange extending through the actuation aperture of the mouthpiece housing component to permit a user to move the mouthpiece inner component between the retracted configuration and the breath collection configuration. Advantageously, this allows for simple manipulation of the mouthpiece module between the retracted and breath collection configurations by a subject, clinician, or another user.

[0038] In examples, the mouthpiece housing component may include a seal between the actuation aperture and the actuation protrusion of the mouthpiece inner component. In some embodiments, the seal may be connected to the actuation aperture. In other examples, the seal may be moulded to the actuation aperture. In some examples, the seal may comprise a rubber material. In other examples, the seal may comprise an elastomer material. The seal may comprise any suitable material for sealing against the actuation aperture and / or the actuation protrusion so as to at least substantially prevent air from flowing through the actuation aperture to the space between the outer surface of the mouthpiece inner component and the inner surface of the mouthpiece housing component. Advantageously, the seal substantially blocks fluid from flowing into the mouthpiece module through the actuation aperture.

[0039] In examples, in the retracted configuration, the fluid in the exhaled breath sample collection device may be substantially sealed in the exhaled breath sample collection device. In some examples, the fluid may be sealed within the exhaled breath sample collection device and free to flow within the mouthpiece housing component and the chamber of the collection vessel. Advantageously, the fluid that is free to flow around the mouthpiece inner component of the mouthpiece module is sealed within the exhaled breath sample collection device. Accordingly, contamination of the sample is at least substantially prevented by providing the exhaled breath sample collection device in a sealed configuration. The sealed configuration also at least substantially prevents the loss of the sample from the exhaled breath sample collection device following collection of the breath sample.

[0040] In examples, the exhaled breath sample collection device may further comprise a cap detachably connected to the mouthpiece breath inlet port so as to seal the exhaled breath sample collection device. Advantageously, the cap prevents air from the external environment from entering the mouthpiece breath inlet port.

[0041] In examples, the mouthpiece inner component may further comprise a mouthpiece exhaust inlet port and a mouthpiece exhaust outlet port. An exhaust passageway may be defined between the mouthpiece exhaust inlet port and the mouthpiece exhaust outlet port, in use. The mouthpiece housing component may include an exhaust aperture.

[0042] In examples, the mouthpiece exhaust outlet port may include a one way valve. The one way valve may permit fluid to flow out of the mouthpiece exhaust outlet port and thus out of the mouthpiece inner component. Additionally, the one way valve may at least substantially prevent fluid from flowing into the mouthpiece inner component through the mouthpiece exhaust outlet port. Advantageously, this prevents contaminants from the external environment from entering the mouthpiece inner component into the exhaust passageway.

[0043] In other examples, the mouthpiece exhaust outlet port may comprise a filter for at least substantially filtering contaminants from air in the external environment to prevent contaminants from entering the mouthpiece inner component into the exhaust passageway. The filter exhaust outlet filter may further prevent potentially infectious agents found in breath, such as virus particles, fungi, bacteria or other microorganisms, from escaping into the environment.

[0044] In examples, the collection vessel may further include a vessel exhaust outlet. The vessel exhaust outlet may permit excess breath and / or displaced fluid to be removed from the collection vessel, in use.

[0045] In examples, in the retracted configuration, the mouthpiece exhaust inlet port may be retracted and positioned within the mouthpiece housing component.

[0046] In examples, in the breath collection configuration, the mouthpiece exhaust inlet port may be coupled to the vessel exhaust outlet to conduct excess breath and / or displaced fluid away from the collection vessel, in use. In some examples, the mouthpiece exhaust inlet port may protrude through the housing aperture and may be coupled to the vessel exhaust outlet to conduct excess breath and / or displaced fluid away from the collection vessel, in use. In other examples, the vessel exhaust outlet may protrude through the housing aperture and into the mouthpiece housing component and may be coupled to the mouthpiece exhaust inlet port to conduct excess breath and / or displaced fluid away from the collection vessel, in use. Advantageously, the vessel exhaust outlet permits excess breath and / or displaced fluid to be removed from the collection vessel, thereby maintaining a constant pressure in the collection vessel.

[0047] In examples, in the breath collection configuration the mouthpiece exhaust outlet port and the exhaust aperture may be aligned to permit excess breath and / or displaced fluid to flow out of the mouthpiece housing component via the mouthpiece exhaust outlet port and the exhaust aperture, in use. Here, aligned means fluid is free to flow from the exhaust passageway defined between the mouthpiece exhaust inlet port and the mouthpiece exhaust outlet port of the mouthpiece inner component through to and out of the exhaust aperture of the mouthpiece housing component.

[0048] In examples, in the retracted configuration the mouthpiece exhaust outlet port and the exhaust aperture may not be aligned and the exhaust aperture is sealed by the outer surface of the mouthpiece inner component. Here, not aligned means fluid is not free to flow from the exhaust passageway defined between the mouthpiece exhaust inlet port and the mouthpiece exhaust outlet port of the mouthpiece inner component through to and out of the exhaust aperture of the mouthpiece housing component. In some examples, the outer surface of the mouthpiece inner component may substantially block fluid from flowing through the exhaust aperture and into the space between the outer surface of the mouthpiece inner component and the inner surface of the mouthpiece housing component. In alternative examples, a separate stopper or lid may block fluid from flowing through the exhaust aperture. In some examples, the separate stopper or lid may be connected to the mouthpiece housing component. In other examples, the separate stopper or lid may be a separate component, connectable to the mouthpiece housing component.

[0049] In examples, in the breath collection configuration, fluid communication between the mouthpiece breath inlet port and the exhaust aperture may be permitted such that the mouthpiece module permits exhaled breath to flow from the mouthpiece breath inlet port to the exhaust aperture, in use. Exhaled breath may be free to flow into the mouthpiece module via the mouthpiece breath inlet port of the mouthpiece inner component. The exhaled breath may then be free to flow through the breath passageway to the mouthpiece breath outlet port. The exhaled breath may then flow into the collection vessel via the mouthpiece breath outlet port and the vessel breath inlet which are coupled together in the breath collection configuration. The exhaled breath may then be free to flow out of the collection vessel and into the exhaust passageway via the vessel exhaust outlet and the mouthpiece exhaust inlet port which are coupled together in the breath collection configuration. The exhaled breath may then exit the mouthpiece module via the mouthpiece exhaust outlet port of the mouthpiece inner component and the exhaust aperture of the mouthpiece housing component.

[0050] In examples, in the retracted configuration, fluid communication between the mouthpiece breath inlet port and the exhaust aperture may be substantially prevented. The mouthpiece exhaust outlet port and the exhaust aperture are not aligned in the retracted configuration, preventing fluid from exiting the mouthpiece module via the exhaust passageway.

[0051] In examples, the collection vessel may be detachably connected to the mouthpiece module. The collection vessel may include a sealing mechanism operable to seal the collection vessel after collection of a breath sample and before the collection vessel is fully detached from the mouthpiece module. In particular, the vessel breath inlet may be sealed by the sealing mechanism after collection of a breath sample and before the collection vessel is fully detached from the mouthpiece module. Thus, the collection vessel may be sealed before being fully removed from the device, substantially preventing sample loss or contamination. This configuration also substantially prevents the loss of the breath sample from the collection vessel once detached from the mouthpiece module.

[0052] The collection vessel and the mouthpiece module may be configured such that the sealing mechanism cooperates with the mouthpiece module to cause the collection vessel to be sealed after collection of a breath sample and before the collection vessel is fully detached from the mouthpiece module.

[0053] In examples, the sealing mechanism may include a sliding seal arranged to seal the chamber of the collection vessel when the vessel is detached from the mouthpiece module. The sliding seal may be configured to seal the chamber of the collection vessel in a closed configuration. The sliding seal, when in the closed configuration, may cover and seal the vessel exhaust outlet and the vessel breath inlet.

[0054] In examples, the collection vessel and the mouthpiece module may be configured such that the sliding seal of the sealing mechanism is urged shut by a lip of the sliding seal that catches on the exhaled breath sample collection device upon detachment of the collection vessel from the mouthpiece module.

[0055] In examples, the collection vessel and the mouthpiece module may be configured such that the sliding seal of the sealing mechanism is urged shut by a lip of the sliding seal that catches on the mouthpiece module upon detachment of the collection vessel from the mouthpiece module.

[0056] In examples, the sealing mechanism may include a resilient sealing material. The sliding seal may abut against the resilient sealing material when the collection vessel is detached from the mouthpiece module such that the resilient sealing material seals the sliding seal in a closed configuration.

[0057] In examples, the resilient sealing material may be a rubber material. For example, the resilient sealing material may be neoprene. In other examples, the resilient sealing material may be an elastomer. For example, the resilient sealing material may be a thermoplastic elastomer. In yet other examples, the resilient sealing material may be any suitable material able to withstand the range of temperatures specified for the device without loss of seal due to contraction or cracking. This may include elements, organic compounds or polymers used in isolation, combination, mixture, alloys or blends, where polymers might be homopolymers, heteropolymers, block co-polymers with linear, branched, dendrimeric, custom or chaotic structures used in isolation or combination with other inorganic and organic materials or compounds, manufactured by chemical synthesis, purification from natural or genetically engineered sources, through cell-free biological fabrication systems, moulding, pressing, 3D printing or other means by which the necessary physicochemical properties can be achieved for the purpose of exhaled breath sample collection.

[0058] The sealing mechanism may be configured such that the sliding seal is urged against the resilient sealing material to reinforce the seal if there is an over pressure inside the collection vessel.

[0059] In examples, the collection vessel may be cooled in use.

[0060] In examples, the exhaled breath sample collection device may include a cooling component configured to cool the collection vessel to a temperature below minus 60 degrees Celsius. In some examples, the cooling component may be configured to cool the collection vessel to a temperature of approximately minus 80 degrees Celsius. In some examples, the cooling component may be configured to cool the collection vessel to a temperature of between minus 80 degrees Celsius and 6 degrees Celsius. In some examples, the cooling component may be configured to control a temperature of the collection vessel to between minus 196 degrees Celsius and 20 degrees Celsius.

[0061] The exhaled breath sample collection device or the mouthpiece module may further comprise a mouthpiece temperature control component configured to maintain the mouthpiece module at a mouthpiece temperature of between 0 degrees Celsius and 46 degrees Celsius. The mouthpiece temperature may be an ambient temperature. The mouthpiece temperature may be a body temperature. The mouthpiece temperature may be substantially 37 degrees Celsius.

[0062] The exhaled breath sample collection device may further comprise a temperature sensor for the mouthpiece temperature control component or for the cooling component. The temperature sensor may be custom, integrated, off-the-shelf or chaotic structure, electronic, solid state, electromagnetic, optical, thermochromatic, or electric, with the option of sensorcentric and inter-sensor communication and processing capabilities in real time. There will be at least one temperature sensor but preferably more, standby, active redundant, located at uniform or non-uniform intervals and spacing in all components to enable reliable, high efficiency thermal regulation.

[0063] According to a third aspect of the invention, there is provided a mask for covering the mouth and nose of a subject.

[0064] In examples, the mask may comprise a first protrusion and a second protrusion. Each of the first and second protrusion are configured to apply pressure to a nose of the subject to prevent breath from being exhaled through the nose.

[0065] Advantageously, the protrusions applying pressure to the nose of the subject prevents the subject from blowing out of their nose when the mask is in use. This allows for the exhaled breath to only be directed from the subject's mouth. The inventors have found that a breath sample collected from the subject's mouth when the nose is blocked provides better quality breath sample.

[0066] In examples, the mask may be for use with the mouthpiece module of the exhaled breath sample collection device.

[0067] In examples, the protrusions may be integrally formed with the mask.

[0068] In examples, the protrusions may be sized and positioned to apply pressure to the subject's nose to prevent breath from being exhaled through the nose.

[0069] In examples, the mask may comprise one or more air apertures to permit air flow into, and out of, the mask when the mask is positioned against a subject's face.

[0070] In examples, the one or more air apertures may comprise a one way valve configured to permit air to flow through the air apertures into the mask and to prevent exhaled breath from flowing out of the mask.

[0071] Advantageously, the one way valve allows the subject to inhale, drawing air from the external environment towards their nose and / or mouth. The one way valve also directs the exhaled breath into the mouthpiece breath inlet port and prevents exhaled breath from escaping into the external environment. This ensures the exhaled breath flows from the mask into the mouthpiece module and / or the exhaled breath sample collection device, thereby improving the quality of the collected breath sample.

[0072] In examples, the mask may comprise a first plurality of air apertures and a second plurality of air apertures. A first one way valve may be positioned on an internal surface of the mask and configured to permit air to flow through the first plurality air apertures into the mask and to prevent exhaled breath from flowing out of the mask through the first plurality of air apertures. In some examples, a second one way valve may be positioned on an internal surface of the mask and configured to permit air to flow through the second plurality air 14 apertures into the mask and to prevent exhaled breath from flowing out of the mask through the second plurality of air apertures.

[0073] In examples, the one or more air apertures may comprise an air filter to filter air from the external environment as it enters the mask. In some examples, the air filter may be comprise a pre-defined pore size so as to at least substantially prevent unwanted airborne particle ingress without impacting inhalation flow rates. In examples, the mask may comprise a first aperture comprising a first air filter. In some examples, the first aperture may further comprise a first one way valve. In some examples, the mask may comprise a second aperture comprising a second air filter. In some examples, the second aperture may further comprise a second one way valve. Advantageously, the air filter filters air inhaled from the external environment so as to reduce, or prevent, the ingress of contaminants such as microorganisms, aerosols, pollutants and / or volatile compounds into the mask and consequently reduce, or prevent, microorganisms, aerosols, pollutants and / or volatile compounds from being inhaled, and subsequently exhaled, by the subject. The air filter may further prevent potentially infectious agents found in breath, such as virus particles, bacteria or other microorganisms, from escaping into the environment.

[0074] In examples, the one way valve may be an umbrella valve.

[0075] The mask may be configured to be detachably connected to the mouthpiece breath inlet port of the mouthpiece module.

[0076] In some examples, the mask may comprise the aforementioned first protrusion and second protrusion, and may further comprise the aforementioned air apertures (and, optionally, may further comprise the aforementioned one way valve(s) and / or the aforementioned air filter(s)).

[0077] According to a fourth aspect of the invention, there is provided a method of collecting a breath sample from a subject.

[0078] In examples, the method may comprise blocking a subject's nose, exhaling into an exhaled breath sample collection device through the subject's mouth while the subject's nose is blocked, and sealing the exhaled breath sample collection device.

[0079] Advantageously, blocking the subject's nose when they exhale reduces the amount of saliva present in the exhaled breath. This improves the quality of the breath sample collected in the exhaled breath sample collection device.

[0080] In examples, the method may further comprise inhaling while the subject's nose is blocked, before the subject exhales into the exhaled breath sample collection device.

[0081] In examples, the exhaled breath sample collection device may be the exhaled breath collection device described above.

[0082] In examples, a mask may be provided to collect the subject's breath and direct the subject's breath into the exhaled breath sample collection device.

[0083] In examples, the subject or a clinician may pinch the nose of the subject to block the subject’s nose. In other examples, the subject’s nose may be blocked using nose clips.

[0084] In examples, the mask may block the subject's nose. The mask may comprise a first protrusion and a second protrusion. Each of the first and second protrusion is configured to apply pressure to a nose of the subject to prevent breath from being exhaled through the nose.

[0085] In examples, the mask may be connected to the exhaled breath sample collection device. In some examples, the mask may be detachably connected to the exhaled breath sample collection device.

[0086] In examples, the subject may be a human subject. In other examples, the subject may be an animal subject. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which:

[0088] FIG. 1A is a side view of a mouthpiece inner component of a mouthpiece module in accordance with an embodiment of the present invention;

[0089] FIG. IB is an isometric view of the mouthpiece inner component of FIG. 1 A;

[0090] FIG. 2 is a cross-sectional view of a mouthpiece housing component of a mouthpiece module in accordance with an embodiment of the present invention;

[0091] FIG. 3 is an isometric view of the mouthpiece module formed by the assembly of the mouthpiece inner component shown in FIG. 1A and FIG. IB with the mouthpiece housing component shown in FIG. 2, the mouthpiece module being shown in a breath collection configuration;

[0092] FIG. 4A is a side, cross-sectional view showing inside the mouthpiece module of FIG. 3, the mouthpiece module being shown in a retracted configuration;

[0093] FIG. 4B is a side, cross-sectional view showing inside the mouthpiece module of FIG. 3, the mouthpiece module being shown in a breath collection configuration;

[0094] FIG. 5 is a side view of a collection vessel in accordance with an embodiment of the present invention;

[0095] FIG. 6 is an isometric view of a sealing mechanism of the collection vessel shown in FIG. 5;

[0096] FIG. 7A is a cross-sectional, side view of the sealing mechanism shown in FIG. 6, the sealing mechanism being shown in an open configuration;

[0097] FIG. 7B is a cross-sectional, side view of the sealing mechanism shown in FIG. 6, the sealing mechanism being shown in a closed configuration;

[0098] FIG. 8A is a cross-sectional, side view of an exhaled breath sample collection device formed by the assembly of the mouthpiece module shown in FIG. 3 with the collection vessel shown in FIG. 5, the mouthpiece module being shown in the retracted configuration;

[0099] FIG. 8B is a cross-sectional, side view of the exhaled breath sample collection device shown in FIG. 8A with the mouthpiece module being shown in the breath collection configuration;

[0100] FIG. 9A is an isometric view of the collection vessel shown in FIG. 5 with the sealing mechanism shown in FIG. 6, the sealing mechanism being shown in a closed configuration;

[0101] FIG. 9B is an alternative view of the collection vessel shown in FIG. 9A;

[0102] FIG. 10 is a distal view of a mask in accordance with an embodiment of the present invention;

[0103] FIG. 11 is a proximal view of the mask shown in FIG. 10;

[0104] FIG. 12 is an isometric view of the exhaled breath sample collection device shown in FIG. 8A and FIG. 8B assembled with the mask shown in FIG. 10;

[0105] FIG. 13 is an isometric view of a removeable cap for use with the mouthpiece inner component shown in FIG. 1 A;

[0106] FIG. 14 is an isometric view of the exhaled breath sample collection device shown in FIG. 8A assembled with the removeable cap shown in FIG. 13. DETAILED DESCRIPTION

[0107] A mouthpiece module 300 for use in an exhaled breath sample collection device 800 in accordance with the present invention is described herein with reference to accompanying FIG. 1A to FIG. 4B. A collection vessel 500 for use in an exhaled breath sample collection device 800 in accordance with the present invention is described herein with reference to accompanying FIG. 5 to FIG. 7B, FIG. 9A and FIG. 9B. An exhaled breath sample collection device 800 is described with reference to FIG. 8A, FIG. 8B and FIG. 12 to FIG. 14. A mask for use with an exhaled breath sample collection device 800 in accordance with the present invention is described herein with reference to accompanying FIG. 10 and FIG. 11.

[0108] As will be described in more detail, the mouthpiece module 300 includes a mouthpiece inner component 100 and a mouthpiece housing component 200.

[0109] Referring now to FIG. 1A and FIG. IB, there is shown a mouthpiece inner component 100 for a mouthpiece module 300. The mouthpiece inner component 100 has defined therein a mouthpiece breath inlet port 102 configured to receive exhaled breath from a subject, or user, and a mouthpiece breath outlet port 104 arranged to be in fluid communication with the mouthpiece breath inlet port 102 to form a breath passageway 106 and to output exhaled breath out of the mouthpiece inner component 100. Exhaled breath can flow from the mouthpiece breath inlet port 102 to the mouthpiece breath outlet port 104 via the breath passageway 106. The mouthpiece inner component 100 further includes a saliva trap 130 in the breath passageway 106 between the mouthpiece breath inlet port 102 and the mouthpiece breath outlet port 104. The mouthpiece breath inlet port 102 is provided at an upstream end of the breath passageway 106. The mouthpiece breath outlet port 104 is provided at a downstream end of the breath passageway 106. The mouthpiece inner component 100 further comprises an inlet seal 122 for providing a seal between the mouthpiece inner component 100 and the mouthpiece housing component 200 (shown in FIGS. 4A and 4B). The inlet seal 122 has a planar surface for covering an inlet aperture 202 of the mouthpiece housing component 200.

[0110] The mouthpiece inner component 100 includes a breath collection interface 108 for collecting the breath of a subject. The breath collection interface 108 is the mouthpiece breath inlet port 102. A subject can cover the mouthpiece breath inlet port 102 with their mouth and exhale, directing their breath into the mouthpiece breath inlet port 102 and into the breath passageway 106. It will be appreciated that the breath collection interface 108 could alternatively be provided by a separate component configured to be connected to the mouthpiece breath inlet port 102. For example, a mask may be used as a breath collection interface 108, as will be described later in more detail with respect to FIG. 10 to FIG. 12.

[0111] The mouthpiece inner component 100 further comprises a mouthpiece exhaust inlet port 110 and a mouthpiece exhaust outlet port 112 defining an exhaust passageway 114 therebetween. The mouthpiece exhaust inlet port 110 is arranged to be in fluid communication with the mouthpiece exhaust outlet port 112. The mouthpiece exhaust inlet port 110 is provided at an upstream end of the exhaust passageway 114. The mouthpiece exhaust outlet port 112 is provided at a downstream end of the exhaust passageway 114. The mouthpiece inner component 100 further comprises an exhaust seal 124 for providing a seal between the mouthpiece inner component 100 and the mouthpiece housing component 200 (shown in FIGS. 4A and 4B). The exhaust seal 124 has a planar surface for covering an exhaust aperture 208 of the mouthpiece housing component 200.

[0112] The mouthpiece inner component 100 has defined therein at each side a first stopper 126 and a second stopper 128. The first stopper 126 and the second stopper 128 protrude from an outer surface 120 of the mouthpiece inner component 100. The first stopper 126 and the second stopper 128 are configured to interact with a first protrusion 214 and a second protrusion 216, respectively, of the mouthpiece housing component 200 (shown in FIG. 4A and FIG. 4B) in order to lock the mouthpiece inner component 100 between configurations as will be described in further detail. The first stopper 126 and the second stopper 128 may each be provided on opposing sides of the mouthpiece inner component 100 so as to interact with first protrusions 214 and second protrusions 216 provided on opposing sides of the mouthpiece housing component 200. The first stopper 126 and the second stopper 128 are provided on cut-out portions of the mouthpiece inner component 100 such that the first stopper 126 and second stopper 128 can flex inwardly. The first stopper 126 and the second stopper 128 have angled and / or rounded surfaces so the first stopper 126 and second stopper 128 can flex inwardly as they interact with the first protrusion 214 and second protrusion 216, respectively.

[0113] The mouthpiece inner component 100 further comprises an actuation protrusion 118. The actuation protrusion 118 is a user-operable flange configured to allow the mouthpiece inner component 100 to be moved between configurations by the subject, a clinician, or another user.

[0114] The mouthpiece inner component 100 comprises a first portion 132 and a second portion 134 coupled to the first portion 132. In this example, the first portion 132 is adhered to the second portion 134 by an adhesive. However, it will be appreciated by a person skilled in the art, that the first portion 132 may be coupled to the second portion 134 by any suitable connection means, such as by virtue of one or more fasteners, or welding processes based on ultrasonic, heat or chemical interactions.

[0115] FIG. 2 is a cross-sectional view of the mouthpiece housing component 200 of a mouthpiece module in accordance with an embodiment of the present invention. The mouthpiece housing component 200 comprises an inlet aperture 202 through which exhaled breath can enter the exhaled breath sample collection device 800. The mouthpiece housing component 200 further comprises a housing aperture 204 in a lower surface of the mouthpiece housing component 200. A connection member in the form of a recess connection member 206 is provided to enable connection of the mouthpiece housing component 200 to a collection vessel 500 (shown in FIG. 5). The mouthpiece housing component 200 further comprises an exhaust aperture 208 through which exhaled breath and / or displaced fluid can exit the exhaled breath sample collection device 800. The mouthpiece housing component 200 further comprises an actuation aperture 210 to accommodate the actuation protrusion 118 of the housing mouthpiece inner component 100. The mouthpiece housing component 200 comprises a hook portion 222 for engagement with a sealing mechanism 600 of the collection vessel 500 (as shown in FIG. 5).

[0116] An inner surface 212 of the mouthpiece housing component 200 is provided with a first protrusion 214 and a second protrusion 216, for engaging with the first stopper 126 and the second stopper 128, respectively, of the mouthpiece inner component 100. The first protrusion 214 is arranged to lock the mouthpiece inner component 100 in a first, retracted configuration and the second protrusion 216 is arrange to lock the mouthpiece inner component 100 in a second, breath collection configuration as will be described in further detail below.

[0117] The mouthpiece housing component 200 is provided with an inlet seal receiving area 218 for receiving the inlet seal 122 of the mouthpiece inner component 100, when the mouthpiece inner component 100 is assembled with the mouthpiece housing component 200 in a first, retracted configuration. Furthermore, the mouthpiece housing component 200 is provided with an exhaust seal receiving area 220 for receiving the exhaust seal 124 of the mouthpiece inner component 100, when the mouthpiece inner component 100 is assembled with the mouthpiece housing component 200 in a second, breath collection configuration, as will be discussed further hereinafter.

[0118] Figure 3 is a diagram of an isometric view of a mouthpiece module 300 formed by the assembly of the mouthpiece inner component 100 shown in FIG. 1A and FIG. IB with the mouthpiece housing component 200 shown in FIG. 2. The mouthpiece inner component 100 is housed within the mouthpiece housing component 200. The mouthpiece breath inlet port 102 of the mouthpiece inner component 100 protrudes through the inlet aperture 202 of the mouthpiece housing component 200. The actuation protrusion 118 of the mouthpiece inner component 100 protrudes through the actuation aperture 210 of the mouthpiece housing component 200. The mouthpiece housing component 200 comprises a seal 302 between the actuation aperture 210 and the actuation protrusion 118 of the mouthpiece inner component 100 to substantially prevent air from entering the mouthpiece module 300 through the actuation aperture 210. The seal 302 may be connected to the actuation aperture 210 of the mouthpiece housing component 200 and provide an interference seal against the actuation protrusion 118. For example, the seal 302 may be over moulded to the actuation aperture 210 of the mouthpiece housing component 200. The actuation protrusion 118 is user-operable to permit a subject, a user or a clinician to move the mouthpiece inner component 100 between the retracted configuration and the breath collection configuration within the mouthpiece housing component 200 as will be described with particular reference to FIG. 4A and FIG. 4B.

[0119] The actuation protrusion 118 and actuation aperture 210 are shown on an upper surface of the mouthpiece inner component 100 and mouthpiece housing component 200, respectively, in FIGS. 1 to 4B. In alternative embodiments, the actuation protrusion 118 and actuation aperture 210 may provided on any suitable position of the mouthpiece inner component 100 and mouthpiece housing component 200, respectively, so as to permit a subject, a user or a clinician to move the mouthpiece inner component 100 between the retracted configuration and the breath collection configuration within the mouthpiece housing component 200.

[0120] FIG. 4A shows a cross-section of the mouthpiece module 300 of FIG. 3, including the mouthpiece inner component 100 within the mouthpiece housing component 200, the mouthpiece module 300 being shown in the first, retracted configuration. In this retracted configuration, the mouthpiece breath outlet port 104 and the mouthpiece exhaust inlet port 110 of the mouthpiece inner component 100 do not extend through the housing aperture 204. The mouthpiece breath outlet port 104 and the mouthpiece exhaust inlet port 110 are fully contained within the mouthpiece housing component 200. Furthermore, the mouthpiece exhaust outlet port 112 of the mouthpiece inner component 100 is not aligned with the exhaust aperture 208 of the mouthpiece housing component 200. In this way, in the retracted configuration, there does not exist a passageway for exhaled breath to flow from the mouthpiece exhaust inlet port 110 through the exhaust aperture 208 and out of the mouthpiece module 300. In the retracted configuration, fluid communication through the exhaust aperture 208 of the mouthpiece housing component 200 is substantially prevented by an outer surface of the mouthpiece inner component 100 in the form of the exhaust seal 124. The exhaust seal 124 forms an interference seal between the mouthpiece inner component 100 and the mouthpiece housing component 200 to at least substantially prevent the flow of air, or another fluid, into an internal space between the mouthpiece inner component 100 and the mouthpiece housing component 200 through the exhaust aperture 208. Additionally, fluid communication through the inlet aperture 202 is substantially prevented by an outer surface of the mouthpiece inner component 100 in the form of the inlet seal 122. The inlet seal 122 forms an interference seal between the mouthpiece inner component 100 and the mouthpiece housing component 200 to at least substantially prevent the flow of air, or another fluid, into an internal space between the mouthpiece inner component 100 and the mouthpiece housing component 200 through the inlet aperture 202.

[0121] FIG. 4B shows a cross-section of the mouthpiece module 300 of FIG. 3 in the breath collection configuration. In contrast with the configuration shown in FIG. 4A, the mouthpiece inner component 100 is displaced downwards in a vertical direction relative to the mouthpiece housing component 200. In this position, the mouthpiece breath outlet port 104 and the mouthpiece exhaust inlet port 110 protrude through the housing aperture 204 of the mouthpiece housing component 200. Furthermore, the mouthpiece exhaust outlet port 112 of the mouthpiece inner component 100 is aligned with the exhaust aperture 208 of the mouthpiece housing component 200. In this way, in the breath collection configuration, there exists a passageway for exhaled breath and / or displaced fluid to flow from the mouthpiece exhaust inlet port 110 through the exhaust aperture 208 and out of the mouthpiece module 300. Yet further, in this breath collection configuration, there exists a passageway for exhaled breath to flow into the mouthpiece breath inlet port 102 through the breath passageway 106 and out of the mouthpiece housing component via the mouthpiece breath outlet port 104.

[0122] The mouthpiece inner component 100 is slidably received within the mouthpiece housing component 200. The mouthpiece inner component 100 is slidable along a vertical axis. The mouthpiece inner component 100 is configured to be slidable between the retracted configuration shown in FIG. 4A and the breath collection configuration shown in FIG. 4B via the user-operable actuation protrusion 118 protruding through the actuation aperture 210 of the mouthpiece housing component 200. The first stopper 126 (shown in FIG. IB) of the mouthpiece inner component 100 is configured to engage with a first protrusion 214 (shown in FIG. 2) of the mouthpiece housing component 200 whereby to lock the mouthpiece inner component 100 into the retracted configuration within the mouthpiece housing component 200. The second stopper 128 (shown in FIG. IB) of the mouthpiece inner component 100 is configured to engage with a second protrusion 216 (shown in FIG. 2) of the mouthpiece housing component 200 whereby to lock the mouthpiece inner component 100 into the breath collection configuration within the mouthpiece housing component 200. As the mouthpiece inner component 100 moves from the breath collection configuration to the retracted configuration a small force is required to move the second stopper 128 of the mouthpiece inner component 100 over the second protrusion 216 of the mouthpiece housing component 200 and then another small force is required to move the first stopper 126 of the mouthpiece inner component 100 over a first protrusion 214 of the mouthpiece housing component 200. Likewise, as the mouthpiece inner component 100 moves from the retracted configuration to the breath collection configuration a small force is required to move the first stopper 126 over the first protrusion 214, and then another small force is required to move the second stopper 128 over the second protrusion 216. Advantageously, the mouthpiece inner component 100 can be locked in each of the retracted and breath collection configurations, and the small force required to move stoppers 126, 128 over protrusions 214, 216 must be provided by a user, subject or clinician operating the actuation protrusion of the mouthpiece inner component. This prevents the mouthpiece inner component from sliding between configurations.

[0123] The mouthpiece inner component 100 is positioned within the mouthpiece housing component 200 such that a space exists between an outer surface 120 of the mouthpiece inner component 100 and an inner surface 212 of the mouthpiece housing component 200. In this way as the mouthpiece module 300 is moved between the retracted configuration and the breath collection configuration, air is free to flow around the mouthpiece inner component 100 within the intermediate space defined between the outer surface 120 of the mouthpiece inner component 100 and the inner surface 212 of the mouthpiece housing component 200. In other words, at least a portion of the outer surface 120 of the mouthpiece inner component 100 is not flush with the inner surface 212 of the mouthpiece housing component 200 such that air is free to flow around the mouthpiece inner component 100 as it is moved between the retracted configuration and the breath collection configuration. The volume of the intermediate space between the mouthpiece inner component 100 and the mouthpiece housing component 200 is at least substantially the same in both the retracted configuration and the breath collection configuration.

[0124] FIGS. 5 and 6 show a collection vessel 500 in accordance with an embodiment of the present invention. The collection vessel 500 comprises a vial 520 having a chamber 502 for receiving and retaining exhaled breath in use. The vial 520 may be a 50 millilitre vial. It will be appreciated by a person skilled in the art that a smaller vial or a larger vial may be used in order to collect a smaller or larger breath sample, respectively. The vial 520 has a bottom 522 and has a sealing plug 504 provided on an upper most portion of the collection vessel 500. The collection vessel 500 further comprises a collection vessel extraction port 524 provided near the bottom 522 of the vial 520 and configured to be useable to remove any collected exhaled breath condensate, or other breath sample, from the vial 520 for analysis. The sealing plug 504 includes a connecting member in the form of a collection vessel connecting portion 516 and an end stop 518 arranged to connect the collection vessel 500 to the mouthpiece housing component 200 of the mouthpiece module 300. The sealing plug 504 further comprises a sealing mechanism 600 in the form of a sliding seal 602 arranged to seal a vessel breath inlet 506 and a vessel exhaust outlet 508 of the collection vessel 500 when the sliding seal 602 is closed and the collection vessel 500 is in a closed configuration.

[0125] The sliding seal 602 is provided with a lip 604 at an end of the sliding seal 602 operable to move the sliding seal 602 into or out of position. When the sliding seal 602 is open, the vessel breath inlet 506 and the vessel exhaust outlet 508 are in an open configuration and air, or any other fluid, is free to flow through the vessel breath inlet 506 and vessel exhaust outlet 508 into, and out of, of the chamber 502. The vessel breath inlet 506 is provided at an end of a vessel breath tube 512 which extends within the chamber 502. The vessel exhaust outlet 508 is provided at the end of a vessel exhaust tube 514 which extends within the chamber 502. The vessel breath tube 512 is longer than the vessel exhaust tube 514.

[0126] FIG. 7A shows a cross-section of the sealing mechanism 600, the sealing mechanism 600 being shown in an open configuration. FIG. 7B shows a diagram of the sealing mechanism 600, the sealing mechanism 600 being shown in a closed configuration. The sealing plug 504 comprises a removeable shelf 606 configured to house the sliding seal 602 when in the open configuration.

[0127] The device may further comprise a collection vessel housing 510. The collection vessel housing 510 comprises a vessel receiving opening 526 provided in a top of the collection vessel housing 510 for insertion and removal of the collection vessel 500 into the collection vessel housing 510. The sealing plug 504 of the collection vessel 500 is configured to connect to the collection vessel housing 510 by a friction seal. Alternatively, the sealing plug 504 may be configured to connect to the collection vessel housing 510 by a screw connection, or by any other suitable means.

[0128] Although not shown, the collection vessel housing 510 may further comprise a temperature control component configured to control a temperature of a collection vessel 500. The temperature control component may be a cooling component configured to actively cool the collection vessel. Alternatively, the temperature control component may be a heating component. Typically, during sample collection, the collection vessel housing 510 may be configured to cool the chamber 502 of the collection vessel 500 to a temperature of minus 80 degrees Celsius. The cooling may be achieved using a Peltier, solid state, or electronic cooling element. As desirable, the temperature of the collection vessel may be controlled to be any temperature from minus 196 degrees Celsius to 20 degrees Celsius.

[0129] Furthermore, either or both of the mouthpiece housing component 200 and the mouthpiece inner component 100 may further comprise a mouthpiece temperature control component. The mouthpiece temperature control component may be a mouthpiece heating component or a mouthpiece cooling component. The mouthpiece temperature control component may be configured to control a temperature of the mouthpiece module 300 during collection of between 0 degrees Celsius to 46 degrees Celsius, though typically the temperature of the mouthpiece module 300 is desirably controlled to be at an ambient temperature.

[0130] It will be appreciated that any suitable method or mechanism for controlling the temperature of either or both of the collection vessel 500 and the mouthpiece module 300 may be used. For example, the temperature control may be achieved by electronic, electrical, chemical, physical, convectional, immersive, hydraulic, liquid, Peltier, solid state or mechanical temperature control mechanisms or methods.

[0131] The collection vessel extraction port 524 provided on the bottom 522 of the vial 520 of the collection vessel 500 allows exhaled breath samples to be removed from the collection vessel 500. The collection vessel 500 may first be centrifuged to collect all of the condensate at an end of the collection vessel 500 adjacent the collection vessel extraction port 524. An overpressure within the collection vessel 500 acts to push the condensate out through the collection vessel extraction port 524 when it is desired to empty the collection vessel 500 for analysis.

[0132] FIG. 8A is a cross-section of an exhaled breath sample collection device 800 in accordance with the present invention, the mouthpiece module 300 of the exhaled breath sample collection device 800 being shown in the retracted configuration. The exhaled breath sample collection device 800 comprises the mouthpiece module 300 shown in FIG. 3 assembled with the collection vessel 500 shown in FIG. 5. The collection vessel 500 is mounted to the mouthpiece module 300 by sliding the collection vessel connecting portion 516 into the recess connection members 206 extending past a bottom surface of the mouthpiece housing component 200 until the end stop 518 is abutted against the recess connection member 206. An interference seal is formed at the housing aperture 204 between the collection vessel 500 and the mouthpiece housing component 200.

[0133] The mouthpiece breath outlet port 104 and the mouthpiece exhaust inlet port 110 are retracted and fully contained within the mouthpiece housing component 200. The mouthpiece breath outlet port 104 and the mouthpiece exhaust inlet port 110 are not directly connected to the vessel breath inlet 506 or the vessel exhaust outlet 508. In this retracted configuration, air is free to flow throughout the exhaled breath sample collection device 800, between the chamber 502 of the collection vessel 500, the breath passageway 106 and the exhaust passageway 114 of the mouthpiece inner component 100, and the space between the mouthpiece inner component 100 and the mouthpiece housing component 200. Yet further, in the retracted configuration air may not enter or exit the exhaled breath sample collection device 800 through the mouthpiece breath inlet port 102 or the mouthpiece exhaust outlet port 112.

[0134] FIG. 8B is a cross-section of the exhaled breath sample collection device 800 shown in FIG. 8A, the exhaled breath sample collection device 800 being shown in the breath collection configuration. The mouthpiece module 300 is converted into the breath collection configuration by depressing the mouthpiece inner component 100 fully within the mouthpiece housing component 200. In the breath collection configuration, the mouthpiece breath outlet port 104 protrudes through the housing aperture 204 and is received within the vessel breath inlet 506. The mouthpiece exhaust inlet port 110 protrudes through the housing aperture 204 and is received within the vessel exhaust outlet 508. Accordingly, a breath passageway is provided from the mouthpiece breath inlet port 102 through the breath passageway 106 into the chamber 502 via the mouthpiece breath outlet port 104 and the vessel breath inlet 506. An exhaust passageway is provided from the chamber 502 into the exhaust passageway 114 and out of the exhaust aperture 208 via the vessel exhaust outlet 508, mouthpiece exhaust inlet port 110 and mouthpiece exhaust outlet port 112. In an alternative embodiment (not shown), the vessel breath inlet 506 may protrude through the housing aperture 204 to fluidly connect with the mouthpiece breath outlet port 104 within the mouthpiece housing component 200. The vessel exhaust outlet 508 may protrude through the housing aperture 204 to fluidly connect with the mouthpiece exhaust inlet port 110 within the mouthpiece housing component 200.

[0135] As the mouthpiece module 300 is moved between the retracted configuration and the breath collection configuration, it is important for air to be able to flow around the mouthpiece inner component 100 in the space defined between the inner surface 212 of the mouthpiece housing component 200 and the outer surface 120 of the mouthpiece inner component 100. This provides for a turbulent flow around the mouthpiece inner component 100 as it is moved and allows for easy movement of the mouthpiece inner component 100 between the retracted configuration and the breath collection configuration. If no space were provided between the inner surface 212 of the mouthpiece housing component 200 and the outer surface 120 of the mouthpiece inner component 100, the difference in pressure above and below the mouthpiece inner component 100 would create a vacuum and a force opposing the force applied to move the mouthpiece inner component 100 between the retracted configuration and the breath collection interface.

[0136] The mouthpiece inner component 100 is shaped and sized in such a way that the outer surface 120 of the mouthpiece inner component 100 does not lie flush with the inner surface 212 of the mouthpiece housing component 200, thereby allowing for the turbulent flow of air around the mouthpiece inner component 100 within the mouthpiece housing component 200 in the exhaled breath sample collection device 800.

[0137] The air within the exhaled breath sample collection device 800 is substantially sealed therein. In particular, in the retracted configuration the air within the space defined between the outer surface 120 of the mouthpiece inner component 100 and the inner surface 212 of the mouthpiece housing component 200 is sealed from the external environment by the interference seal between the inlet seal 122 and the inlet aperture 202, the interference seal between the exhaust seal 124 and the exhaust aperture 208, the seal 302 between the actuation protrusion 118 and the actuation aperture 210 and finally the interface seal provided at the housing aperture 204 between the collection vessel 500 and the mouthpiece housing component 200. A removeable cap 1300 (shown in FIG. 13) may additionally be provided to cover the mouthpiece breath inlet port 102, preventing air from the external environment from entering the exhaled breath sample collection device 800 via the mouthpiece breath inlet port 102 when mouthpiece module 300 is in the retracted configuration and the exhaled breath sample collection device 800 is not in use. Alternatively, a valve may be provided in the mouthpiece breath inlet port 102 or the breath passageway 106 to prevent air from the external environment from entering the exhaled breath sample collection device 800 when not in use.

[0138] The exhaled breath sample collection device 800 is provided in the retracted configuration with the removeable cap 1300 covering the mouthpiece breath inlet port 102. A subject, clinician or other user can move mouthpiece module 300 into the breath collection configuration via the actuation protrusion 118. Once in the breath collection configuration, the removeable cap 1300 is removed and a subject can exhale breath into the exhaled breath sample collection device 800. The exhaled breath flows from the mouthpiece breath inlet port 102 into the chamber 502 of the collection vessel 500 via the breath passageway 106, the mouthpiece breath outlet port 104 and the vessel breath inlet 506. The exhaled breath is cooled within the exhaled breath sample collection device 800 and exhaled breath sample is collected in the chamber 502 of the collection vessel 500.

[0139] When the sample collection is completed, the mouthpiece module 300 is moved back to the retracted configuration by raising the mouthpiece inner component 100 within the mouthpiece housing component 200. In the retracted configuration, the exhaled breath sample collection device 800 is again at least substantially sealed from the external environment so as to prevent contamination of the breath sample in the collection vessel 500.

[0140] The collection vessel 500 can be removed from exhaled breath sample collection device 800 by sliding the collection vessel connecting portion 516 of the collection vessel 500 out of the recess connection members 206 of the mouthpiece housing component 200. As the collection vessel 500 slides out of the mouthpiece housing component 200, the hook portion 222 of the mouthpiece housing component 200 latches on the lip 604 of the sliding seal 602 on the collection vessel 500, causing the sliding seal 602 to close, thereby sealing the chamber 502 of the collection vessel 500. In this way, the collection vessel 500 is provided in a fully closed configuration such that the chamber 502 of the collection vessel 500 is sealed from the external environment before the collection vessel 500 is fully removed from the mouthpiece housing component 200, substantially preventing contamination of the collection vessel 500.

[0141] The sealing plug 504 is removable from the collection vessel 500 in order to access the breath sample within the chamber 502 of the collection vessel 500.

[0142] The sealing plug 504 may be formed by a resilient sealing material so as to provide a reliable seal for the collection vessel 500. Even when the pressure within the collection vessel 500 is increased, the collection vessel 500 remains sealed. The sealing plug 504 may be formed from a rubber material. The sealing plug 504 may be formed from an elastomer material. For example, the sealing plug 504 may be formed from a thermoplastic elastomer material.

[0143] FIG. 9A and FIG. 9B show a diagram of the collection vessel 500 with the sealing mechanism 600 in the closed configuration following detachment of the collection vessel 500 from the mouthpiece housing component 200. The removeable shelf 606 is detachably connected to the sealing mechanism 600. For example, the removeable shelf 606 may be connected to the sealing mechanism 600 by thinned portions of material, allowing for the sealing mechanism to be snapped off and removed from the sealing mechanism 600. FIG. 9A shows the collection vessel 500 in the closed configuration prior to the removal of the removeable shelf 606. FIG. 9B shows the collection vessel 500 in the closed configuration after the removal of the removeable shelf 606.

[0144] FIGS. 10 and 11 show a mask 1000 in accordance with another aspect of the present invention. FIG. 10 shows a distal view of the mask 1000 with respect to a subject (a wearer of the mask 1000). FIG. 11 shows a proximal view of the mask 1000 with respect to the subject. The mask 1000 is provided to cover the mouth and nose of a subject. The mask 1000 may be a breath collection interface 108 in accordance with the present invention. The mask 1000 is configured for use with the mouthpiece inner component 100. The mask 1000 comprises a mask breath outlet 1002 sized and shaped to connect with the mouthpiece breath inlet port 102 of the mouthpiece inner component 100, thereby providing a fluid connection between the mask breath outlet 1002 and the mouthpiece breath inlet port 102. The connection between the mask breath outlet 1002 and the mouthpiece breath inlet port 102 permits exhaled breath to enter the breath passageway 106 of the mouthpiece inner component 100 via the mask breath outlet 1002 and mouthpiece breath inlet port 102. The mask 1000 is configured to be detachably connected to the mouthpiece breath inlet port 102.

[0145] The mask 1000 further comprises a plurality of air apertures 1004 to permit air to flow into, and out of, the mask 1000 when it is positioned against a subject's face. The mask may have a first plurality of air apertures 1004 and a second plurality of air apertures 1004 positioned on opposing sides of the mask. Additionally, the mask 1000 comprises a one way valve 1006 configured to permit air to flow through the air apertures 1004 into the mask 1000 and prevent exhaled breath from flowing out of the mask 1000. In this way, the entirety of the exhaled breath is directed into the mouthpiece inner component 100 of the mouthpiece module 300, thereby improving the quality of the breath sample, whilst still allowing a wearer of the mask (the subject) to breathe in air from the environment. The one way valve 1006 may be provided on a proximal, inner surface of the mask 1000. The one way valve 1006 may be an umbrella valve. A first one way valve 1006 may be provided to cover the first plurality of air apertures 1004 and a second one way valve 1006 may be provided to cover the second plurality of air apertures 1004. Alternatively, only a single one way valve 1006 may be provided to cover only the first plurality of air aperture 1004. It will be appreciated by a person skilled in the art that the air apertures 1004 may include appropriately sized air filters to filter environmental airborne matter such as microorganisms, aerosols, pollutants and volatile compounds. In an alternative embodiment (not shown) the mask may comprise only a first air aperture, or a first and a second air aperture, each air aperture comprising a seal.

[0146] The mask 1000 further comprises a first protrusion 1008 and a second protrusion 1008. Each of the first and second protrusions 1008 are configured to apply pressure to a nose of the subject to prevent the wearer of the mask 1000 (the subject) from inhaling and / or exhaling breath through the nose. The mask ensures the exhaled breath comes from a subject's mouth. Yet further, the protrusions 1008 blocking the nose of the subject can also cause the subject to only inhale air through their mouth prior to exhaling the exhaled breath for the sample.

[0147] A method for collecting a breath sample from a subject according to an aspect of the invention will now be described. The method comprises covering a subject’s mouth and nose with a mask, for example the mask 1000 described above. The subject then breathes into an exhaled breath sample collection device, for example the exhaled breath sample collection device 800. In particular, the subject exhales breath into the mouthpiece inner component 100. The mask 1000 directs the subject’s exhaled breath into the exhaled breath sample collection device 800. The exhaled breath sample collection device is then sealed to seal the breath sample within the exhaled breath sample collection device 800. The method may further comprise blocking a subjects nose. This can be done by using a nose clip or by the subject or clinician pinching the nose of the subject. Alternatively the subject's nose can be blocked using a mask, for example the mask 1000 shown above comprising the protrusions 1008 configured to block the subject's nose. The subject then exhales breath through their mouth into an exhaled breath sample collection device with their nose blocked. The method may further include inhaling while the subject's nose is blocked, prior to the subject exhaling exhaled breath into the exhaled breath sample collection device 800. The method may include inhaling and exhaling through the subject's mouth and directing the exhaled air into the exhaled breath sample collection device for a period of time. The period of time may be from 5 seconds to 1 hour. Preferably, the period of time may be from 15 minutes to 30 minutes. The period of time may be 15 minutes. The period of time may be 30 minutes. Alternatively, the method may include collecting a predetermined number of exhalations from the subject’s mouth and directing the exhaled air into the exhaled breath sample collection device. In one example, a fraction of an exhaled breath may be collected. For example, an end portion of an exhaled breath may be collected. In another example, a mid portion of an exhaled breath may be collected. In another example, any defined portion of an exhaled breath may be collected. In another example, an exhalation manoeuvre involving vocalization, slow exhalation, fast exhalation, or interrupted exhalation, may be used to adjust the constituents of exhaled breath or define the fraction of the breath that might be collected. In another example, one exhaled breath may be collected. In another example, from 1 to 1000 exhaled breaths may be collected.

[0148] The inventors have found that covering the nose and mouth of the subject using a mask during the collection of the sample provides a better quality breath sample. Specifically, the inventors have surprisingly found that the amount of saliva excreted into the breath collection device is substantially reduced, or eliminated, when the subject wears a mask during collection of the breath sample. Yet further, a mouthpiece received in the subject’s mouth causes the subject to overproduce saliva and saliva pools in the exhaled breath sample collection device, for example in a saliva trap in the exhaled breath sample collection device. By providing a mask which covers a subject’s mouth and nose, instead of being received in the subject’s mouth, the subject produces less saliva.

[0149] In one example, subjects breathed into the exhaled breath sample collection device 800 with their mouth and nose covered by a mask having a first plurality of air apertures and a second plurality of air apertures each covered with an umbrella valve so as to permit air from the external environment to flow into the mask when the subjects breathed in and prevent exhaled breath from flowing out of the mask thereby directing the exhaled breath into the exhaled breath sample collection device 800. The subjects breathed into the mask for time periods of 15 minutes and 30 minutes. The subjects then breathed directly into the mouthpiece breath inlet port 102 into the exhaled breath sample collection device 800 without the mask covering the nose and mouth for time periods of 15 minutes and 30 minutes. The volume of exhaled breath condensate was collected and measured in microliters when the subject used the device with a mask and without a mask and the volume of fluids in the saliva trap of the exhaled breath sample collection device was measured when the subject used the device with and without the mask. In order to measure the volume of fluid collected in the saliva trap, the collection vessel and the mask were first detached from the mouthpiece module, and the mouthpiece module was then positioned with the mouthpiece breath inlet port facing downwards and tapped against a filter paper or against a 50 millilitre conical tube to recover any liquid accumulated in the saliva trap.

[0150] Table 1 below shows experimental data comparing the volume of exhaled breath condensate in the collection vessel with and without the mask. Table 2 below shows experimental data comparing the volume of fluid recovered from the saliva trap in microliters with and without the mask. The results show that there is substantially the same volume of sample collected in the collection vessel with or without the mask. However, there is significantly less volume of fluid in the saliva trap when the subject uses the mask. This reduces the likelihood of saliva entering the chamber 502 of the collection vessel 500. As such, the breath sample is of better quality when the subject's nose and mouth are covered by the mask as there is less saliva produced by the subject and so the presence of saliva in the collected breath sample is reduced, or eliminated.

[0151] In conclusion, providing the exhaled breath sample collection device 800 with a mask helps to reduce the subject’s saliva production and reduces the amount of saliva pooling in the saliva trap, minimizing any risk of overflow into the collection vessel 500. Accordingly, providing the mask reduces the likelihood of leakage resulting in liquid pooling in the saliva trap or other parts of the exhaled breath sample device 800. Table 1: exhaled breath condensate volume in collection tube (in microliters) Sampling time: 15 minutes 30 minutes Presence of mask: without with without with 2,070 1,960 3,330 3,340 1,803 1,514 3,089 2,940 1,783 1,642 3,000 3,000 Table 2: Volume of fluids recovered from the Saliva Trap (in microliters) Sampling time: 15 minutes 30 minutes Presence of mask: without with without with 270 0 629 0 230 0 800 0 500 0 95 10

[0152] FIG. 12 is an isometric view of the exhaled breath sample collection device shown in FIG. 8A and FIG. 8B assembled with the mask shown in FIG. 10 and FIG. 11;

[0153] FIG. 13 is an isometric view of a removeable cap 1300 for use with the mouthpiece inner component 100 illustrated in FIG. 1A and FIG. IB. The removeable cap 1300 is shaped to fit on the end of the mouthpiece breath inlet port 102 of the mouthpiece housing component 200, thereby preventing fluid from entering the mouthpiece breath inlet port 102 from outside the device. The removeable cap 1300 is configured (i.e. shaped and sized) to connect with the mouthpiece breath inlet port 102 by an interference fit. Alternatively, the removeable cap 1300 may be configured to connect to the mouthpiece breath inlet port 102 via a screw connection or any other suitable connection means.

[0154] FIG. 14 is an isometric view of the exhaled breath sample collection device 800 shown in FIG. 8A and FIG. 8B assembled with the removeable cap shown in FIG. 13. The mouthpiece module 300 of the exhaled breath sample collection device 800 is in the retracted configuration, and the exhaled breath sample collection device 800 is at least substantially sealed so as to prevent air from the external environment from entering the device. This substantially prevents contamination of the device and of a sample contained therein.

[0155] Throughout the description and claims of this specification, the words "comprise" and "contain" and variations of them mean "including but not limited to", and they are not intended to (and do not) exclude other components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural unless the context otherwise requires. In particular, where the indefinite article is used, the specification is to be understood as contemplating plurality as well as singularity, unless the context requires otherwise.

[0156] Features, integers or characteristics described in conjunction with a particular aspect, embodiment or example of the invention are to be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith.

[0157] All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not restricted to the details of any foregoing embodiments. It will be appreciated that various changes and modifications can be made to the present invention without departing from the scope of the present application. The invention is as defined in the appended claims.

Claims

1. A mouthpiece module for an exhaled breath sample collection device, the mouthpiece module comprising:a mouthpiece housing component comprising a housing aperture; anda mouthpiece inner component comprising a mouthpiece breath inlet port and a mouthpiece breath outlet port, the mouthpiece inner component defining a breath passageway between the mouthpiece breath inlet port and the mouthpiece breath outlet port, in use;wherein the mouthpiece inner component is received within the mouthpiece housing component and moveable between:a retracted configuration in which the mouthpiece breath outlet port is retracted and positioned within the mouthpiece housing component; anda breath collection configuration in which the mouthpiece breath outlet port permits exhaled breath to flow from the mouthpiece breath inlet port through the breath passageway and out of the mouthpiece housing component via the mouthpiece breath outlet port, in use; andwherein at least a part of an outer surface of the mouthpiece inner component is spaced apart from an inner surface of the mouthpiece housing component in both the retracted configuration and the breath collection configuration such that a fluid is free to flow around the mouthpiece inner component as the mouthpiece inner component moves between the retracted configuration and the breath collection configuration.

2. The mouthpiece module of claim 1, wherein in the breath collection configuration the mouthpiece breath outlet port protrudes through the housing aperture to permit exhaled breath to flow from the mouthpiece breath inlet port through the breath passageway and out of the mouthpiece housing component via the mouthpiece breath outlet port, in use.

3. The mouthpiece module of claim 1 or claim 2, wherein in the breath collection configuration the mouthpiece breath outlet port is configured to fluidly connect with a collection vessel to permit exhaled breath to flow from the mouthpiece inlet port through the breath passageway and into the collection vessel.

4. The mouthpiece module of any one of claims 1 to 3, wherein the mouthpiece housing component comprises an inlet aperture, wherein the mouthpiece breath inlet port protrudes through the inlet aperture, and wherein the outer surface of the mouthpiece inner componentcovers the inlet aperture surrounding the mouthpiece breath inlet port in both the retracted configuration and the breath collection configuration.

5. The mouthpiece module of any one of claims 1 to 4, wherein the mouthpiece inner component is slidably received within the mouthpiece housing component and slidable between the retracted configuration and the breath collection configuration.

6. The mouthpiece module of any one of claims 1 to 5, further comprising a seal configured to prevent fluid from flowing into the breath passageway through the mouthpiece breath inlet port when not in use.

7. The mouthpiece module of claim 6, wherein the seal is a removeable cap.

8. The mouthpiece module of any one of claims 1 to 7, wherein the mouthpiece module further comprises a breath collection interface configured to be fluidly connected to the mouthpiece breath inlet port of the mouthpiece inner component.

9. The mouthpiece module of any one of claims 1 to 7, wherein the mouthpiece breath inlet port defines a breath collection interface.

10. The mouthpiece module of any one of claims 1 to 9, wherein the mouthpiece inner component comprises a saliva trap in the breath passageway between the mouthpiece breath inlet port and the mouthpiece breath outlet port.

11. The mouthpiece module of any one of claims 1 to 10, wherein the mouthpiece inner component comprises an actuation protrusion protruding through an actuation aperture of the mouthpiece housing component to permit the mouthpiece inner component to be moved between the retracted configuration and the breath collection configuration.

12. The mouthpiece module of claim 11, wherein the mouthpiece housing component comprises a seal between the actuation aperture and the actuation protrusion of the mouthpiece inner component.

13. An exhaled breath sample collection device comprising:the mouthpiece module according to any one of claims 1 to 12; anda collection vessel defining a chamber for collecting an exhaled breath sample, in use, the collection vessel comprising a vessel breath inlet for admitting exhaled breath into the chamber,wherein, in the breath collection configuration, the mouthpiece breath outlet port is coupled to the vessel breath inlet to permit exhaled breath to flow from the mouthpiece breath inlet port into the chamber of the collection vessel via the breath passageway, the mouthpiece breath outlet port and the vessel breath inlet.

14. The exhaled breath sample collection device of claim 13, wherein, in the retracted configuration, the fluid in the exhaled breath sample collection device is substantially sealed therein.

15. The exhaled breath sample collection device of claim 13 or 14, wherein the mouthpiece inner component further comprises a mouthpiece exhaust inlet port and a mouthpiece exhaust outlet port, the mouthpiece inner component defining an exhaust passageway between the mouthpiece exhaust inlet port and the mouthpiece exhaust outlet port, in use, and wherein the mouthpiece housing component comprises an exhaust aperture.

16. The exhaled breath sample collection device of any one of claims 13 to 15, wherein the collection vessel further comprises a vessel exhaust outlet.

17. The exhaled breath sample collection device of claim 16, wherein, in the retracted configuration, the mouthpiece exhaust inlet port is retracted and positioned within the mouthpiece housing component, and wherein in the breath collection configuration the mouthpiece exhaust inlet port is coupled to the vessel exhaust outlet to conduct excess breath and / or displaced fluid away from the collection vessel in use.

18. The exhaled breath sample collection device of any one of claims 15 to 17, wherein: in the breath collection configuration the mouthpiece exhaust outlet port and the exhaust aperture are aligned to permit excess breath and / or displaced fluid to flow out of the mouthpiece housing component via the mouthpiece exhaust outlet port and the exhaust aperture, in use; andin the retracted configuration the mouthpiece exhaust outlet port and the exhaust aperture are not aligned and the exhaust aperture is sealed by the outer surface of the mouthpiece inner component.

19. The exhaled breath sample collection device of any one of claims 15 to 18, wherein in the breath collection configuration, fluid communication between the mouthpiece breath inlet port and the exhaust aperture is permitted such that the mouthpiece module permits exhaled breath to flow from the mouthpiece breath inlet port to the exhaust aperture, in use.

20. The exhaled breath sample collection device of any one of claims 15 to 19, wherein in the retracted configuration, fluid communication between the mouthpiece breath inlet port and the exhaust aperture is substantially prevented.

21. The exhaled breath sample collection device of any one of claims 13 to 20, wherein the collection vessel is detachably connected to the mouthpiece module, and wherein the collection vessel comprises a sealing mechanism operable to seal the collection vessel after collection of a breath sample and before the collection vessel is fully detached from the mouthpiece module.

22. The exhaled breath sample collection device of claim 21, wherein the collection vessel and the mouthpiece module are configured such that the sealing mechanism cooperates with the mouthpiece module to cause the collection vessel to be sealed after collection of a breath sample and before the collection vessel is fully detached from the mouthpiece module.

23. The exhaled breath sample collection device of claim 21 or 22, wherein the sealing mechanism comprises a sliding seal arranged to seal the chamber of the collection vessel when the collection vessel is detached from the mouthpiece module.

24. The exhaled breath sample collection device of claim 23, wherein the collection vessel and the mouthpiece module are configured such that the sliding seal of the sealing mechanism is urged shut by a lip of the sliding seal that catches on the mouthpiece module upon detachment of the collection vessel from the mouthpiece module.

25. The exhaled breath sample collection device of claim 23 or 24, wherein the sealing mechanism further comprises a resilient sealing material, and the sliding seal abuts against the resilient sealing material when the collection vessel is detached from the mouthpiece module such that the resilient sealing material seals the sliding seal in a closed configuration.

26. The exhaled breath sample collection device of any one of claims 13 to 25, wherein the collection vessel is cooled in use.38

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