Patent Publication Number: US-2022218229-A1

Title: Exhaled breath condensate collection device and a kit of parts therefor

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation of U.S. Patent Application No. 16/083,246, filed Sep. 7, 2018, which is a U.S. National Stage application of International Application Serial No. PCT/GB2017/050627, filed Mar. 8, 2017, which claims priority to Great Britain Application Serial No. GB 1604011.5, filed Mar. 8, 2016, each of which is incorporated by reference herein in its entirety. 
    
    
     FIELD 
     This invention relates to an exhaled breath condensate collection device, a kit of parts for the exhaled breath condensate collection device and a method of exhaled breath condensate collection. 
     BACKGROUND 
     Exhaled breath vapour typically contains a mixture of different components, which can give an indication of airway disease and physiology for a subject. It is known to extract these components by passing exhaled breath directly through a cooled collection vessel in order to initiate condensing of many of the constituent parts of the exhaled breath vapour. The exhaled breath condensate remains in the collection vessel, whilst any remaining vapour continues out of the collection vessel. 
     One of the known systems is described in U.S. Pat. No. 8,491,494 which discloses a mouthpiece connected to a collection vessel and a cooled aluminium sleeve useable to cool the collection vessel in use. 
     It is in this context that the present invention has been devised. 
     SUMMARY 
     During development, the inventor has realised that collected exhaled breath condensate using the device described in U.S. Pat. No. 8,491,494 is susceptible to contamination when the mouthpiece is removed from the collection vessel because a separate sealing cap is only applied to the collection vessel after removal of the mouthpiece. Between removal of the mouthpiece 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. Furthermore, the collection vessel may heat up between collection and sealing, resulting in evaporation of some of the collected exhaled breath condensate. Thus, some of the collected exhaled breath condensate sample may escape from the collection vessel. 
     In accordance with the present inventions there is provided a kit of parts for an exhaled breath condensate collection device. The kit comprises a mouthpiece module comprising a breath passageway defined in the mouthpiece module providing fluid conduction from a mouthpiece breath inlet port for receiving exhaled breath to a mouthpiece breath outlet port in use. The kit further comprises a collection vessel for insertion into the device for cooling in use. The collection vessel defines a sealed and resealable chamber for collecting exhaled breath condensate in use. The collection vessel has a vessel breath inlet for admitting exhaled breath into the chamber. The kit of parts is configured such that the collection vessel is: insertable into the device into an sample collection configuration in which the vessel breath inlet is unsealed and in fluid communication with the mouthpiece breath outlet port of the mouthpiece module; and removable from the device in a sample containment configuration in which the collection vessel chamber is resealed. One or more parts of the kit of parts is configured and/or operable such that the collection vessel is caused to be resealed into the sample containment configuration after sample collection before the collection vessel is fully removed from the device. 
     Thus, contamination of the sample is substantially reduced by providing the collection vessel in a sealed configuration prior to insertion into the device, and resealing the collection vessel into the sample containment configuration after sample collection but before the collection vessel is fully removed from the device. This configuration also substantially prevents loss of the sample from the collection vessel. 
     One or more parts of the kit of parts may be configured and/or operable such that the collection vessel is caused to be unsealed into the sample collection configuration on or following insertion of the collection vessel into the device. Thus, the collection vessel is only unsealed on or following insertion of the collection vessel into the device, which substantially prevents contamination of the collection vessel from contaminants outside the device. 
     The mouthpiece module may be configured such that the mouthpiece breath outlet port is moveable to cause the vessel breath inlet to become unsealed on or following insertion of the collection vessel into the device. Thus, a simple mechanical movement is used to unseal the collection vessel. 
     The vessel breath inlet may be sealed by a film seal. The mouthpiece module may be configured such that the mouthpiece breath outlet port is moveable to penetrate the film on coupling of the mouthpiece breath outlet port in fluid communication with the vessel breath inlet. 
     The collection vessel may be caused to be unsealed into the sample collection configuration by a sliding seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a rotary seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a thermal seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a pneumatic seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a mechanical seal. The collection vessel may be caused to be unsealed into the sample collection configuration by an electromechanical seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a chemical seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a linear seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a circular seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a constricting seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a spigot seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a valve seal. The collection vessel may be caused to be unsealed into the sample collection configuration by a vacuum based seal. 
     The rotary seal may be an iris mechanism. The thermal seal may be a thermal sealing of plastics. The chemical seal may be a chemical glue seal. It will be appreciated that other sealing methods and mechanisms will be apparent to the person skilled in the art. 
     Additional sealing or resealing mechanisms may involve thermally activated seals, photochemically activated seals such as UV crosslinking or other compositive wavelength-reactive materials. 
     The collection vessel may further comprise a sealed vessel exhaust outlet to emit collected breath in use. The mouthpiece module may further comprise an exhaust passageway coupled to a mouthpiece exhaust inlet port to conduct exhausted breath away from the collection vessel in use. The mouthpiece exhaust inlet port may be moveable to cause the vessel exhaust outlet to become unsealed on or following insertion of the collection vessel into the device. 
     The vessel exhaust outlet may be sealed by a film seal. The mouthpiece exhaust inlet port may be moveable to penetrate the film on coupling of the mouthpiece exhaust inlet port in fluid communication with the vessel exhaust outlet. 
     The sealing methods described hereinbefore may be used to seal one or both of the vessel breath inlet and the vessel exhaust outlet. 
     The mouthpiece module may be formed such that the mouthpiece breath outlet port and mouthpiece exhaust inlet port are rigidly coupled to one or more moveable components. The mouthpiece module may be configured to be user-operable to cause the movement of the one or more moveable components to cause the collection vessel to become unsealed and in the sample collection configuration in use. 
     The device may comprise at least two manual, mechanical, electric or electronic sensors and/or switches that ensure proper alignment and locking of the mouthpiece module with the collection vessel upon insertion and/or initiation of the collection vessel through manual or housing-controlled electronic and/or mechanical actuation. The sensors and switches may be electromagnetic sensors and switches. 
     Basically, a system that uses electromagnetism to snap-on and snap-off the collector vessel and the mouthpiece module so that everything is appropriately aligned and held in place using just electromagnets. 
     The collection vessel may comprise a resealing mechanism configured to be caused to reseal the collection vessel as the collection vessel is removed from the device or at least from the part of the device in which the collection vessel is cooled in use. 
     The resealing mechanism may be one of the sealing methods or mechanisms hereinbefore described. 
     The collection vessel and one or more other parts of the device may be configured such that the resealing mechanism is configured to cooperate with the one or more other parts of the device to cause the collection vessel to be resealed. 
     The resealing mechanism may be biased towards a sealed configuration. The collection vessel and one or more other parts of the device may be configured to keep the resealing mechanism out of the sealed configuration when inserted into the device for sample collection and allow the resealing mechanism to return to the sealed configuration as the collection vessel is removed from the device. Thus, the collection vessel is sealed before being fully removed from the device, substantially preventing sample loss or contamination. 
     The resealing mechanism may comprise a sliding lid which when in the sealed configuration covers and seals at least the vessel breath inlet. The resealing mechanism may comprise a sliding lid which when in the sealed configuration covers and seals at least the vessel exhaust outlet. 
     The collection vessel and one or more other parts of the device may be configured such that the sliding lid of the resealing mechanism is urged open upon insertion into the device. The sliding lid of the resealing mechanism may be urged open by a lip of the lid that catches on the device. 
     The collection vessel and one or more other parts of the device may be configured such that the sliding lid of the resealing mechanism is urged shut upon removal from the device. The sliding lid of the resealing mechanism may be urged shut by a lip of the sliding lid that catches on the device. 
     A collection vessel housing of the kit may be configured for receiving the collection vessel for cooling during sample collection. The mouthpiece module may be configured to engage with the lip of the sliding lid to cause the device to be urged open and/or shut. 
     The sliding lid may abut in the mechanism against a resilient sealing material configured to seal the vessel when the lid is closed. The resilient sealing material may be a rubber material. The resilient sealing material may be neoprene. The resilient sealing material may be any other 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 EBC collection. 
     The resealing mechanism may be configured such that the sliding lid is urged against the resilient sealing material to reinforce the seal if there is an overpressure inside the collection vessel. 
     The mouthpiece module may further comprise a seal configured to prevent air from flowing in the breath passageway at least through the mouthpiece breath inlet port when not in use. The seal may comprise a sealing member formed from a rubber material. 
     The kit of parts may further comprise a cooling component configured to cool the collection vessel to a temperature below minus 60 degrees Celsius. The cooling component may be configured to cool the collection vessel to a temperature of approximately minus 80 degrees Celsius. In some embodiments, 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 embodiments, the cooling component may be configured to control a temperature of the collection vessel to between minus 196 degrees Celsius and 20 degrees Celsius. 
     The mouthpiece module may further comprise a mouthpiece configured to be in fluid communication with the mouthpiece breath inlet port in use. 
     The mouthpiece module may further comprise a saliva trap between the mouthpiece breath inlet port and the mouthpiece breath outlet port. 
     The kit of parts 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. 
     The kit of parts 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 sensor-centric and inter-sensor communication and processing capabilities in real time. There will be at least one temperature sensore 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. 
     The kit of parts may comprise temperature control components configured to use advanced digital control and digital signal processing to maintain stable and controlled temperature during all phases of operation located in the non-disposable components of the device (housing). 
     Heating elements may be instantiated and located around or embedded within the entirety or parts of the housing of the disposable mouthpiece to maintain the temperature within the range specified hereinbefore through preset modes. The temperature may be maintained at an ambient temperature or at a temperature of breath on exhalation. The temperature of breath on exhalation may be measured in real-time through mouthpiece sensors or may be determined based on a user-input specification provided via a digital control interface. 
     Cooling elements for the disposable sample collection device may be located or embedded on a non-disposable digital processing unit housing (DPU). The digital processing unit may interface with a co-housed intelligent processing, control, data acquisition and storage unit with integrated user interface display and control unit. 
     The cooling elements surrounding the disposable unit or embedded within the DPU casing may consist of any one or more of the following: 
     The cooling elements may comprise plates, straight, flat, angled, geometrically organised, curved, flanged or finned with/without millimetre, micrometer or nanometer features such as tubes, channels pores, fins or other custom or chaotic designs that achieve high thermal conductivity through maximisation of surface area, flow, conductivity or radiation that enables accelerated, high efficiency thermodynamic exchange. 
     The cooling elements may comprise coils, flat, curved, concentric, corkscrew, lateral, horizontal, vertical or interdigitating achieving the same effects as in the preceding paragraph. 
     The cooling elements may comprise custom developed chaotic structures. The cooling elements may comprise fins or pins. The cooling elements may comprise any structure achieving maximum surface area coverage of the collection vessel and thermodynamic exchange ratio optimisation. 
     The different components may rely on interference fit on entry at ambient temperature to enable easier electrical, mechanichal, electromechanical or manual means collection vessel extraction from the non-disposable housing upon actuation completion. 
     The interface between electronic/electrically controlled components and a control unit or processing unit may be of a serial interface nature, typically USB (universal serial bus). 
     The collection vessel may be configured to be centrifuge resistant and shaped to cause exhaled breath condensate to collect at a bottom of the chamber during centrifuging. 
     The collection vessel may further comprise an extraction port for removal of the exhaled breath condensate from the collection vessel. The extraction port may be arranged at the location of the chamber at which the condensate collects during centrifuging. 
     The extraction port may be coupleable to a syringe or an inserted needle. The extraction port may comprise a low resistance needle-puncture site. The extraction port may comprise a pressure cap assembly. The extraction port may comprise a ‘female’ snap cap assembly. An overpressure in the collection vessel may cause the exhaled breath condensate collected adjacent the extraction port to be ejected from the collection vessel and into the syringe or the inserted needle. A ‘male’ coupling to the ‘female’ snap cap assembly may snap the extraction port to an open position to enable overpressure in the collection vessel to cause the exhaled breath condensate collected adjacent to the extraction port to be ejected from the collection vessel into further device. The further device may be a single or possibly multiple parallel or serially arranged closed analytical device, or an open analytical device which may include a spraying device of portable or fixed nature. The dimensions of the coupling mechanism may accommodate at least one but possibly more fluidic coupling channels of fixed or variable dimensions. The fluidic coupling channels may be centimetre to micrometre fluidic coupling channels. 
     The invention may extend to a mouthpiece module for use in the exhaled breath condensate collection device as described previously. 
     The invention may extend to a collection vessel for use in the exhaled breath condensate collection device as described previously. 
     The invention may extend to an exhaled breath condensate collection device as described previously. 
     Viewed from another aspect, the present invention provides a method of operating an exhaled breath condensate device as described previously. The method comprises: inserting the collection vessel into the device to be cooled and to cause the collection vessel to become unsealed and ready for sample collection; breathing into the mouthpiece module to conduct breath to the collection vessel to collect exhaled breath condensate therein; and removing the collection vessel from the device to cause the collection vessel to be resealed before the collection vessel is fully removed from the device. 
     The method may further comprise centrifuging the collection vessel to cause the exhaled breath condensate to collect at a bottom of the vessel. The method may further comprise extracting the collected exhaled breath condensate from the collection vessel through a port provided at the bottom of the collection vessel. 
     The invention may extend to a computer-readable medium having computer-readable data representative of one or more parts of the kit of parts for an exhaled breath condensate collection device, or a mouthpiece module or a collection vessel, each as described previously, and useable by a  3 D printer to print the one or more parts of the kit of parts. 
    
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
       Embodiments of the invention are further described hereinafter with reference to the accompanying drawings, in which: 
         FIG. 1 a    is a diagram showing a mouthpiece inner component of a mouthpiece module in accordance with an embodiment of the present invention; 
         FIG. 1 b    is a diagram showing a mouthpiece inner component of a mouthpiece module in accordance with another embodiment of the present invention; 
         FIG. 2 a    is an isometric view of the mouthpiece inner component of  FIG. 1   a;    
         FIG. 2 b    is an isometric view of the mouthpiece inner component of  FIG. 1   b;    
         FIG. 3  is an isometric view of a lid for use with the mouthpiece inner component illustrated in  FIGS. 1 a    and  2   a;    
         FIG. 4  is a diagram showing a mouthpiece housing component of a mouthpiece module in accordance with an embodiment of the present invention; 
         FIG. 5  is an isometric view of the mouthpiece housing component shown in  FIG. 4 ; 
         FIG. 6  is a diagram of a collection vessel housing in accordance with an embodiment of the present invention; 
         FIG. 7  is an isometric view of the collection vessel housing shown in  FIG. 6 ; 
         FIG. 8 a    is a diagram of a collection vessel in accordance with an embodiment of the present invention; 
         FIG. 8 b    is a diagram of a collection vessel in accordance with another embodiment of the present invention; 
         FIG. 9 a    is an isometric view of the collection vessel shown in  FIG. 8   a;    
         FIG. 9 b    is an isometric view of the collection vessel shown in  FIG. 8   b;    
         FIG. 10  is a diagram of the mouthpiece module formed by the assembly of the mouthpiece inner component shown in  FIGS. 1 a  and 2 a    with the mouthpiece housing component shown in  FIGS. 4 and 5 , the mouthpiece module being shown in a sealed configuration; 
         FIG. 11  is a diagram of the mouthpiece module of  FIG. 10 , shown in a sample collection configuration; 
         FIG. 12  is a diagram showing the mouthpiece module of  FIGS. 10 and 11  assembled with the collection vessel housing shown in  FIGS. 6 and 7 ; 
         FIG. 13  is a diagram showing the assembly of  FIG. 12  additionally comprising the collection vessel shown in  FIGS. 8 a    and  9   a;    
         FIG. 14  is a diagram showing the assembly of  FIG. 13  in a sample collection configuration. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1 a    is a diagram showing a mouthpiece inner component  120  of a mouthpiece module  100  in accordance with an embodiment of the present invention.  FIG. 1 a    is provided in a semi-transparent view whereby to illustrate internal details of the mouthpiece inner component  120 .  FIG. 2 a    is an isometric view of the mouthpiece inner component  120  of  FIG. 1 a   .  FIG. 2 a    does not exhibit the same semi-transparent nature as Figure la, whereby to more clearly illustrate the configuration of the mouthpiece inner component  120 . The mouthpiece inner component  120  has defined therein a mouthpiece breath inlet port  122  configured to receive exhaled breath from a subject and a mouthpiece breath outlet port  124  arranged to be in fluid communication with the mouthpiece breath inlet port  122  to form a breath passageway and to output exhaled breath out of the mouthpiece module  100 . The mouthpiece inner component  120  further comprises a saliva trap  126  in a mouthpiece first chamber  130  formed in the breath passageway between the mouthpiece breath inlet port  122  and the mouthpiece breath outlet port  124 . A dividing member  128  divides the mouthpiece inner component  120  and defines a boundary of the mouthpiece first chamber  130 . The mouthpiece first chamber  130  comprises a mouthpiece breath inlet tube  132 , providing the mouthpiece breath inlet port  122  at an upstream end of the mouthpiece breath inlet tube  132 . The mouthpiece first chamber  130  further comprises a mouthpiece breath outlet tube  134  providing a breath passageway from within the mouthpiece first chamber  130  to the mouthpiece breath outlet port  124  provided at a downstream end of the mouthpiece breath outlet tube  134 . A region of the mouthpiece breath outlet tube  134  adjacent the mouthpiece breath outlet port  124  is shaped to have an inwardly tapered shape, whereby an area of the passageway through the mouthpiece breath outlet tube  134  reduces in a downstream direction. In this way, the mouthpiece breath outlet tube  134  provides a dibble at the downstream end. The mouthpiece inner component  120  further comprises a mouthpiece exhaust tube  138 , being provided with a mouthpiece exhaust inlet port  136  at an upstream end and a mouthpiece exhaust outlet port  140  at a downstream end. The mouthpiece exhaust tube  138  is shaped to have an inwardly tapered shape, whereby an area of the passageway through the mouthpiece exhaust tube  138  reduces in an upstream direction. In this way, the mouthpiece exhaust tube  138  provides a dibble at the upstream end. The mouthpiece inner component  120  is provided in a shell  148  having holes defined therein to accommodate passage therethrough of the mouthpiece breath inlet port  122 , mouthpiece breath outlet port  124 , mouthpiece exhaust inlet port  136  and the mouthpiece exhaust outlet port  140 . The shell  148  has defined therein at each side an elongate channel  146  running substantially parallel to the direction of the mouthpiece breath outlet tube  134  in the region of the mouthpiece breath outlet port  124 . The shell  148  is further provided with a support flange  144  around an inner side of the periphery of the shell  148 . A support member  142  may be referred to as a septum and is provided within the shell  148  to support the mouthpiece breath outlet tube  134  and the mouthpiece exhaust tube  138  in a deformed configuration whereby to ensure the mouthpiece exhaust inlet port  136  and the mouthpiece breath outlet port  124  are rigidly positioned even when pressure is applied against the mouthpiece exhaust inlet port  136  or the mouthpiece breath outlet port  124 . 
       FIG. 1 b    is a diagram showing a mouthpiece inner component of a mouthpiece module being substantially similar to that shown in  FIG. 1 a    apart from the hereinafter described differences.  FIG. 2 b    is an isometric view of the mouthpiece inner component of  FIG. 1 b   . A shell  148  comprises both a first elongate channel  146  and a second elongate channel  147  each running substantially parallel to the direction of the mouthpiece breath outlet tube  134  in the region of the mouthpiece breath outlet port  124 . As can be seen in  FIG. 2 b   , the mouthpiece inner component  120  comprises a first inner component  121  and a second inner component  123 . The second inner component  123  comprises the first elongate channel  146 , the mouthpiece breath inlet tube  132  and the second shell  149  defining the boundary of the mouthpiece first chamber  130 . The second inner component  123  is removable from the first inner component  121  of the mouthpiece inner component  120  for cleaning of the saliva trap formed therein. The first inner component  121  further comprises two connection members  125  arranged to slidably engage with corresponding connection members  127  provided on the second inner component  123 . 
       FIG. 3  is an isometric view of a lid for use with the mouthpiece inner component illustrated in  FIGS. 1 a  and 2 a   . The lid  150  comprises a planar lid member  152 , shaped to close the mouthpiece inner component having a boundary shaped to interface with the support flange  144  of the mouthpiece inner component  120 , in particular having defined therein a recess  154  arranged to match the elongate channel  146  provided in the shell  148  of the mouthpiece inner component  120 . The lid  150  further comprises a handle  156  extending from the planar lid member  152  and configured to allow the lid to be easily removed from the mouthpiece inner component  120 . 
       FIG. 4  is a diagram showing a mouthpiece housing component  160  of a mouthpiece module in accordance with an embodiment of the present invention.  FIG. 5  is an isometric view of the mouthpiece housing component  160  shown in  FIG. 4 . The mouthpiece housing component  160  provides a mouthpiece  162 . It will be appreciated that the mouthpiece  162  could alternatively be provided by a separate component configured to be connected to the mouthpiece housing component  160 . The mouthpiece housing component  160  further comprises a mouthpiece exhaust  164  through which exhaled breath can exit the device. The mouthpiece housing component  160  is further provided with a mouthpiece housing breath outlet port  166  and a mouthpiece housing exhaust inlet port  168  on a lower surface of the mouthpiece housing component  160 . A connection member in the form of a recess connection member  170  is provided to enable connection of the mouthpiece housing component  160  to a further component. An internal surface of the mouthpiece housing component  160  is provided with an internal protrusion  172  on each side of the mouthpiece housing component  160 , whereby to interface with the elongate channel  146  formed in the mouthpiece inner component  120  when the mouthpiece inner component  120  is inserted within the mouthpiece housing component  160  as will be discussed further hereinafter. The mouthpiece housing component  160  further comprises a film seal (not shown) arranged to extend across the mouthpiece housing breath outlet port  166  and the mouthpiece housing exhaust inlet port  168 . 
       FIG. 6  is a diagram of a collection vessel housing  200  in accordance with an embodiment of the present invention.  FIG. 7  is an isometric view of the collection vessel housing  200  shown in  FIG. 6 . The collection vessel housing  200  comprises a connection member in the form of a collection vessel housing connecting protrusion  202  and an end stop  204  arranged to connect the collection vessel housing  200  to the mouthpiece housing component  160 . The collection vessel housing  200  has defined therein a collection vessel receiving opening  206  provided in a side of the collection vessel housing  200  for insertion and removal of a collection vessel into the collection vessel housing  200 . The collection vessel housing  200  is further provided with an internal flange  208  arranged to support the collection vessel and an opposing opening  212  provided opposite the collection vessel receiving opening  206  whereby to aid removal of the collection vessel from the collection vessel housing  200 . The collection vessel housing  200  is also provide with a collection vessel housing engagement spacing whereby to operate a function of the collection vessel. The operation of the device and structure of the collection vessel will be described in more detail below. 
     Although not shown, the collection vessel housing  200  may further comprise a temperature control component configured to control a temperature of a collection vessel inserted into the collection vessel housing  200 . 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  200  may be configured to cool the collection vessel to a temperature of −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. 
     Furthermore, either or both of the mouthpiece housing component  160  and the mouthpiece inner component  120  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  100  during collection of between 0 degrees Celsius to 46 degrees Celsius, though typically the temperature of the mouthpiece module  100  is desirably controlled to be at an ambient temperature. 
     It will be appreciated that any suitable method or mechanism for controlling the temperature of either or both of the collection vessel and the mouthpiece module 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. 
       FIG. 8 a    is a diagram of a collection vessel  300  in accordance with an embodiment of the present invention.  FIG. 9 a    is an isometric view of the collection vessel  300  shown in  FIG. 8 a   . The collection vessel  300  comprises a phial  302  having a bottom  304  and a cap  320  on an uppermost portion of the phial  302 . The collection vessel  300  further comprises a collection vessel extraction port  306  provided near the bottom  304  of the phial  302  and configured to be useable to remove collected condensate from the phial  302  for analysis. The cap  320  comprises a sealing mechanism in the form of a sliding lid  322  arranged to seal a vessel breath inlet  326  and a vessel exhaust outlet  328  when the lid is closed. The sliding lid  322  is provided with a lip  324  at an end of the sliding lid  322  operable to move the sliding lid  322  into or out of position. When the sliding lid  322  is open, the vessel breath inlet  326  and the vessel exhaust outlet  328  are accessible. In a sealed configuration, the collection vessel further comprises a seal in the form of a film (not shown) which covers the vessel breath inlet  326  and the vessel exhaust outlet  328  whereby to seal the collection vessel  300 , even when the sliding lid  322  is open. The vessel breath inlet  326  is provided at an end of a vessel breath tube  330  which extends within the phial  302 . The vessel exhaust outlet  328  is provided at an end of a vessel exhaust tube  332  which extends within the phial  302 . The vessel breath tube  330  is longer than the vessel exhaust tube  332 . The cap  320  is configured to connect to the phial  302  by a screw connection. 
       FIG. 8 b    is a diagram of a collection vessel being substantially similar to that shown in  FIG. 8 a    apart from the hereinafter described differences.  FIG. 9 b    is an isometric view of the collection vessel shown in  FIG. 8 b    without the sliding lid  322 . The cap  320  comprises an inclined shelf  321  arranged to engage with the sliding lid  322  and resist unsealing of the collection vessel  300  by free movement of the sliding lid  322  out of the recess provided in the cap  320 . In comparison with  FIG. 9 a   ,  FIG. 9 b    does not show a sliding lid  322  to better shown the internal structure of the cap  320 . 
       FIG. 10  is a diagram of the mouthpiece module  100  formed by the assembly of the mouthpiece inner component  120  shown in  FIGS. 1 a  and 2 a    with the mouthpiece housing component  160  shown in  FIGS. 4 and 5 , the mouthpiece module being shown in a sealed configuration. The mouthpiece inner component  120  is inserted within the mouthpiece housing component  160 . In this first, sealed configuration, the mouthpiece breath outlet port  124  and the mouthpiece exhaust inlet port  136  of the mouthpiece inner component  120  do not extend through the mouthpiece housing breath outlet port  166  and the mouthpiece housing exhaust inlet port  168 , such that the film seal remains intact. Furthermore, the mouthpiece breath inlet port  122  and the mouthpiece exhaust outlet port  140  are not aligned with the mouthpiece  162  and the mouthpiece exhaust  164  respectively. In this way, in the sealed configuration, there does not exist a breath passageway from the mouthpiece  162  to the mouthpiece housing breath outlet port  166  or from the mouthpiece housing exhaust inlet port  168  to the mouthpiece exhaust  164  and the mouthpiece module  100  can be considered to be sealed. Although not shown, it will be appreciated that the lid  150  is also provided on the mouthpiece inner component  120  to seal the mouthpiece module. 
       FIG. 11  is a diagram of the mouthpiece module of  FIG. 10 , shown in a sample collection configuration. In contrast with the configuration shown in  FIG. 10 , the mouthpiece inner component  120  is fully seated within the mouthpiece housing component  160 . In this position, the dibbles formed by the mouthpiece breath outlet port  124  and the mouthpiece exhaust inlet port  136  puncture though the film seal and extend through the mouthpiece housing breath outlet port  166  and the mouthpiece housing exhaust inlet port  168 . Furthermore, the mouthpiece breath inlet port  122  and the mouthpiece exhaust outlet port  140  are aligned with the mouthpiece  162  and the mouthpiece exhaust  164  respectively. In this way, in the sample collection configuration, there exists a breath passageway from the mouthpiece  162  to the mouthpiece housing breath outlet port  166  and from the mouthpiece housing exhaust inlet port  168  to the mouthpiece exhaust  164  and the mouthpiece module  100  can be considered to be unsealed. As in  FIG. 10 , it will be appreciated that the lid  150  is also provided on the mouthpiece inner component  120  to substantially prevent contamination of a breath sample. 
       FIG. 12  is a diagram showing the mouthpiece module of  FIGS. 10 and 11  assembled with the collection vessel housing shown in  FIGS. 6 and 7 . The collection vessel housing  200  is mounted to the mouthpiece module  100  by sliding the collection vessel housing connecting protrusion  202  on each side of the collection vessel housing  200  into the two recess connection members  170  extending past a bottom surface of the mouthpiece housing component  160  until the end stop  204  is abutted against the recess connection member  170 . The collection vessel housing  200  is typically attached to the mouthpiece module  100  whilst the mouthpiece is in the sealed configuration described in relation to  FIG. 10  previously. 
       FIG. 13  is a diagram showing the assembly of  FIG. 12  additionally comprising the collection vessel shown in  FIGS. 8 a  and 9 a   . The collection vessel  300  is inserted into the collection vessel housing  200  through the collection vessel receiving opening  206 . The cap  320  of the collection vessel  300  is wider than the phial  302 , so the cap slides over the internal flange  208  provided within the collection vessel housing  200 . The lip  324  on the sliding lid  322  is configured to engage with the collection vessel housing engagement spacing  210  on insertion of the collection vessel  300  into the collection vessel housing  200 .  FIG. 14  is a diagram showing the assembly of  FIG. 13  in a sample collection configuration. As the collection vessel  300  is fully inserted into the collection vessel housing  200 , the lip  324  acts to withdraw the sliding lid  322  whereby to expose the sealing film (not shown) covering the openings of the vessel breath inlet  326  and the vessel exhaust outlet  328 . Once the collection vessel  300  is fully inserted into the collection vessel housing  200 , the mouthpiece module is converted into the sample collection configuration by depressing the mouthpiece inner component  120  fully within the mouthpiece housing component  160 , whereby to cause the dibbles formed by the mouthpiece breath outlet port  124  and the mouthpiece exhaust inlet port  136  to pierce the sealing film and provide a breath passageway from the mouthpiece  162  to the mouthpiece exhaust  164  via the collection vessel  300 . 
     When sample collection is completed, the mouthpiece module  100  is reconfigured by raising the mouthpiece inner component  120  within the mouthpiece housing component  160  whereby to substantially prevent contamination of the collection vessel  300 . The collection vessel  300  is removed from the collection vessel housing  200  by pushing the collection vessel  300  through the opposing opening  212  provided in the collection vessel housing  200 . As the collection vessel  300  slides out of the collection vessel housing  200 , the collection vessel housing engagement spacing acts to operate on the lip  324  of the sliding lid  322  on the collection vessel  300 , causing the sliding lid  322  to close, thereby sealing the collection vessel  300 . In this way, the collection vessel  300  is provided in a fully sealed configuration before the collection vessel  300  is fully removed from the collection vessel housing  200 , substantially preventing contamination of the collection vessel  300 . The cap  320  of the collection vessel  300  comprises a resilient sealing member in the form of a rubber seal (not shown), whereby to provide a reliable seal for the collection vessel  300 . Even when the pressure within the collection vessel  300  increased, the collection vessel  300  remains sealed. Typically, when the collection vessel  300  is removed from the cooled environment within the collection vessel housing  200 , the temperature of the collection vessel will increase, therefore increasing the pressure within the collection vessel  300 . 
     The collection vessel extraction port  306  provided on the bottom of the phial  302  of the collection vessel  300  allows condensate to be removed from the collection vessel  300 . In one embodiment, the collection vessel  300  is first centrifuged to collect all of the condensate at an end of the collection vessel  300  adjacent the collection vessel extraction port  306 . An overpressure within the collection vessel  300  acts to push the condensate out through the collection vessel extraction port  306  when it is desired to empty the collection vessel  300  for analysis. 
     In summary, there is provided a kit of parts for an exhaled breath condensate collection device. The kit comprises a mouthpiece module ( 100 ) comprising a breath passageway defined in the mouthpiece module ( 100 ) providing fluid conduction from a mouthpiece breath inlet port ( 122 ) for receiving exhaled breath to a mouthpiece breath outlet port ( 124 ) in use. The kit further comprises a collection vessel ( 300 ) for insertion into the device for cooling in use. The collection vessel ( 300 ) defines a sealed and resealable chamber for collecting exhaled breath condensate in use. The collection vessel has a vessel breath inlet ( 326 ) for admitting exhaled breath into the chamber. The kit of parts is configured such that the collection vessel ( 300 ) is: insertable into the device into an sample collection configuration in which the vessel breath inlet ( 326 ) is unsealed and in fluid communication with the mouthpiece breath outlet port ( 124 ) of the mouthpiece module ( 100 ); and removable from the device in a sample containment configuration in which the collection vessel chamber is resealed. One or more parts of the kit of parts is configured and/or operable such that the collection vessel ( 300 ) is caused to be resealed into the sample containment configuration after sample collection before the collection vessel ( 300 ) is fully removed from the device. 
     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. 
     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. 
     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. The invention is as defined in the appended claims.