Patent Publication Number: US-2017347918-A1

Title: Breath capture device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     Not Applicable 
     STATEMENT RE: FEDERALLY SPONSORED RESEARCH/DEVELOPMENT 
     Not Applicable 
     BACKGROUND 
     1. Technical Field 
     The present disclosure relates generally to a fluid capturing device, and more specifically to a device sized and configured to capture at least a portion of an exhalation phase of a user&#39;s breath for diagnostic analysis. 
     2. Description of the Related Art 
     Medical treatment and care generally require knowledge of an underlying medical condition. A determination of the underlying medical condition may be obtained by various diagnostic tests or evaluations. Along these lines, a rapidly emerging diagnostic tool in the medical community is breath analysis, which is a desirable, non-invasive, relatively low cost tool allowing medical professionals to quickly diagnose a number of different medical conditions. For instance, breath analysis may be used to detect asthma, blood alcohol, lung cancer, breast cancer, diabetes, cystic fibrosis, malaria, Parkinson&#39;s Disease, leukemia, organ transplant rejection, radiation exposure, preeclampsia of pregnancy, liver disease, kidney disease, heart disease, sepsis, pneumonia, tuberculosis, among others. 
     Many breath analysis systems identify characteristic biomarkers and analyze signal patterns with high sensitivity and accuracy to reach a medical diagnosis. In many cases, the diagnosis can be made in just a few minutes on site, rather than sending a test sample to an off-site laboratory, as is typically required of a blood sample or other samples of bodily fluids. The on-site testing of the breath sample also mitigates potential sample degrading and contamination during sample transport. 
     Although the advantages of breath sampling are well-known, certain challenges remain in connection with obtaining the breath sample. For instance, it is important to collect the breath sample such that the sample is free from environmental contaminants. Furthermore, it is also desirable to collect alveolar fluid from the patient which is more representative of biomarkers coming from the patient&#39;s body and not environmental volatile organic compounds (VOCs) that the patient may be inhaling from the ambient environment, such as cleaning compounds or other environmental VOCs. 
     Accordingly, there is a need in the art for a device capable of easily and effectively collecting a breath sample for subsequent diagnostic testing and analysis. Various aspects of the present disclosure address this particular need, as will be discussed in more detail below. 
     BRIEF SUMMARY 
     In accordance with one embodiment of the present disclosure, there is provided a device and related method for capturing a user&#39;s breath for diagnostic analysis and testing, preferably the last 25-35% of the exhalation phase, which is commonly associated with the user&#39;s alveolar breath. 
     According to one embodiment, the breath capturing device includes a body having an internal reservoir, an inlet, a first outlet, and a second outlet. A first fluid pathway extends between the inlet and the internal reservoir, a second fluid pathway extends between the internal reservoir and the first outlet, and a third fluid pathway extends between the internal reservoir and the second outlet. A first valve is positioned within the first fluid pathway and is configured to restrict fluid flow along the first fluid pathway to fluid flow from the inlet to the internal reservoir above a first fluid pressure. A second valve is positioned within the second fluid pathway and is configured to restrict fluid flow along the second fluid pathway to fluid flow from the internal reservoir to the first outlet above a second fluid pressure greater than the first fluid pressure. A third valve is positioned within the third fluid pathway and is selectively transitional between an open configuration, wherein fluid flows along the third fluid pathway, and a closed configuration, wherein fluid is restricted from flowing along the third fluid pathway. 
     The body may include a central body, a first end body engageable with the central body via snap-fit engagement, and a second end body engageable with the central body via snap-fit engagement. The first end body may include a mouthpiece adapted to enable a mouth of a user to breathe into the device. A first gasket may extend between the central body and the first end body to create a fluid tight seal therebetween, and a second gasket may extend between the central body and the second end body to create a fluid tight seal therebetween. A bladder may be coupled to the first end body and the second end body, with the bladder at least partially defining the internal reservoir. 
     The first valve may be transitional between an open configuration, wherein fluid flows along the first fluid pathway, and a closed configuration, wherein fluid flow is restricted along the first fluid pathway, with the first valve being biased towards the closed position by a first biasing force. The first valve may be configured to transition to the open position when fluid entering the first valve is above the first fluid pressure to overcome the first biasing force. 
     The second valve may be transitional between an open configuration, wherein fluid flows along the second fluid pathway, and a closed configuration, wherein fluid flow is restricted along the second fluid pathway, with the second valve being biased towards the closed position by a second biasing force. The second valve may be configured to transition to the open position when fluid entering the second valve is above the second fluid pressure to overcome the second biasing force. 
     The first fluid pressure and the second fluid pressure may be associated with respective magnitudes to enable a portion of an expiration phase by a human and directed into the inlet to be captured within the internal reservoir. 
     According to another embodiment, there is provided a pressure actuated fluid capturing device comprising a body having an internal reservoir. An inlet valve is coupled to the body and is in fluid communication with the internal reservoir, with the inlet valve being biased toward a closed position wherein fluid is restricted from flowing into the internal reservoir through the inlet valve. The inlet valve transitions to an open position to enable fluid flow into the internal reservoir through the inlet valve in response to fluid pressure applied thereto exceeding a first pressure threshold. An outlet valve is coupled to the body and is in fluid communication with the internal reservoir. The outlet valve is biased toward a closed position wherein fluid is restricted from flowing out of the internal reservoir through outlet valve. The outlet valve transitions to an open position to enable fluid flow out of the internal reservoir through the outlet valve in response to fluid pressure applied thereto exceeding a second pressure threshold greater than the first pressure threshold. The first and second pressure thresholds are associated with respective fluid pressures to enable a portion of an expiration phase by a human and directed into the inlet valve to be captured within the internal reservoir. 
     According to yet another embodiment, there is provided a method of capturing a portion of a user&#39;s breath. The method includes: receiving breath exhaled from a user in a breath capturing device; capturing a first portion of the breath exhaled by the user within the breath capturing device such that the fluid pressure within the breath capturing device increases; venting at least a portion of the captured breath from the breath capturing device when the fluid pressure within the breath capturing device exceeds a prescribed pressure threshold; and capturing a second portion of the breath exhaled by the user and subsequent to the venting step in response to the fluid pressure within the breath capturing device falling below the prescribed pressure threshold. 
     All steps of the method may be performed during a continuous exhalation phase by the user. The first and second portions of the breath may be exhaled by the user during a continuous exhalation phase. 
     The breath capturing device may include an exhaust port which remains closed while capturing the first portion of the breath exhaled by the user, and which opens during the venting step. 
     The venting step may include transitioning a vent valve from a closed position to an open position in response to fluid pressure within the breath capturing device exceeding a prescribed vent threshold. The step of capturing the second portion of the breath may include transitioning the vent valve from the open position to the closed position in response to the fluid pressure within the breath capturing device falling below the prescribed vent threshold. 
     The present disclosure will be best understood by reference to the following detailed description when read in conjunction with the accompanying drawings. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       These and other features and advantages of the various embodiments disclosed herein will be better understood with respect to the following description and drawings, in which: 
         FIG. 1  is an upper perspective view of one embodiment of a breath capturing device; 
         FIG. 2  is an exploded perspective view of the breath capturing device depicted in  FIG. 1 ; 
         FIG. 3  is a cross sectional view of the breath capturing device during a first exhalation phase; 
         FIG. 3A  is an enlarged, sectional view depicting cooperative engagement between a first end body and a central body; 
         FIG. 4  is a cross sectional view of the breath capturing device during a second exhalation phase; 
         FIG. 5  is a cross sectional view of the breath capturing device during a third exhalation phase; 
         FIG. 6  is a schematic diagram illustrating signal communication between the breath capturing device and a breath testing device; 
         FIG. 7  is an upper perspective view of the breath capturing device and the breath testing device, prior to the breath capturing device being cooperatively engaged with the breath testing device; 
         FIG. 8  is an upper perspective view of the breath capturing device cooperatively engaged with the breath testing device; 
         FIG. 9  is a cross sectional view of the breath capturing device cooperatively engaged with the breath testing device to enable extraction of the collected breath sample; and 
         FIG. 10  is a pressure curve approximating a typical human breathing cycle. 
     
    
    
     Common reference numerals are used throughout the drawings and the detailed description to indicate the same elements. 
     DETAILED DESCRIPTION 
     The detailed description set forth below in connection with the appended drawings is intended as a description of certain embodiments of a breath capturing device and related method of use, and is not intended to represent the only forms that may be developed or utilized. The description sets forth the various structure and/or functions in connection with the illustrated embodiments, but it is to be understood, however, that the same or equivalent structure and/or functions may be accomplished by different embodiments that are also intended to be encompassed within the scope of the present disclosure. It is further understood that the use of relational terms such as first and second, and the like are used solely to distinguish one entity from another without necessarily requiring or implying any actual such relationship or order between such entities. 
     Various aspects of the present disclosure are directed toward capturing a user&#39;s breath within a device to enable medical testing of the breath captured within the device. Certain embodiments are specifically directed toward capturing only a portion of the user&#39;s exhalation phase of the user&#39;s breath, such as approximately the last one-third of the user&#39;s exhalation phase, which corresponds to the aveolar breath. 
     According to one embodiment, and referring now to the drawings, a breath capturing device  10  includes a body  12  having an internal reservoir  14 , an inlet  16 , a first outlet  18 , and a second outlet  20  (e.g., an extraction port).  FIG. 1  shows the device  10  in an assembled configuration, while  FIG. 2  shows the device  10  in an exploded configuration. According to one embodiment, the body  12  is a multi-piece assembly generally including a central body  22 , a first end body  24  and a second end body  26 . The first and second end bodies  24 ,  26  may be formed from Polyether Ether Ketone (PEEK) or other materials known in the art. The first end body  24  includes a mouthpiece  28  and a first connector  30  coupled to the mouthpiece  28 . Preferably, the mouthpiece  28  and the first connector  30  are integrally formed with each other. The mouthpiece  28  is tubular and includes an outer surface and an inner surface defining an opening  32  extending axially through the first end body  24 . The mouthpiece  28  is sized and configured to allow a user to blow or exhale into the device  10  through the mouthpiece  28  with the user&#39;s mouth. An end cap  34  may be included to cover an end portion of the mouthpiece  28  during periods of nonuse. The end cap  34  may be placed over the mouthpiece  28  to prevent ambient air from being drawn into the device  10  while a collected breath sample is retrieved from the device  10 . Furthermore, the mouthpiece  28  may be covered by the end cap to allow the device  10  to be moved without ambient air flowing into the device  10 . The first connector  30  extends radially outward from the mouthpiece  28  and includes an end wall  36  and a first connecting surface  38  (see  FIGS. 2, 3 ) extending axially from the end wall  36 . The first connecting surface  38  includes a pair of circumferential grooves  39 ,  41  spaced apart from each other, with the grooves  39 ,  41  being adapted to facilitate engagement between the first end body  24  and the central body  22 , as will be described in more detail below. 
     The second end body  26  includes an end wall  40 , an extension wall  42  and a second connector  44 . The end wall  40  includes a pair of openings extending therethrough forming respective ones of the first and second outlets  18 ,  20  to facilitate selective fluid flow through the second end body  26 , as will be described in more detail below. A third opening  46  (see  FIG. 2 ) may be formed in the end wall  40  to provide a mounting structure for an umbrella valve  48 . The extension wall  42  extends from a peripheral portion of the end wall  40  in an axial direction toward the second connector  44 . The second connector  44  includes a second connector surface  50  including a pair of circumferential grooves spaced apart from each other, with the grooves being adapted to facilitate engagement between the second end body  26  and the central body  22 , as will be described in more detail below. The pair of circumferential grooves formed in the second connector  44  are similar to the pair of circumferential grooves formed in the first connector  30 . 
     According to one embodiment, the second end body  26  is specifically configured to be complimentary in shape to a corresponding opening or mating structure formed on breath testing machine  110  (see  FIGS. 7 and 8 ) to enable cooperative engagement between the second end body  26  and the breath testing machine  110  for purposes of transferring the breath sample from the capturing device  10  to the testing machine  110 . As shown in the exemplary embodiment, the extension wall  42  of the second end body  26  includes a pair of opposed, convex, arcuate segments  45 , which are separated by a pair of opposed arcuate, concave segments  47 . The testing device  110  includes a pair of opposed tabs  112  which are complimentary to the pair of opposed concave segments  45  formed on the capturing device  10 , such that when the capturing device  10  is inserted into the testing device  110 , the complimentary arrangement between the tabs  112  and the concave surfaces  45  registers the capturing device  10  relative to the testing device  110 . Of course, the scope of the present disclosure is not limited to the particular configuration of the second end body  26  shown and described herein and the corresponding structure on the breath testing device  110  depicted in the drawings. In this regard, the second end body  26  and the breath testing device  110  may include other configurations without departing from the spirit and scope of the present disclosure. 
     The central body  22  serves as a shell which extends at least partially over the internal reservoir  14  and between the first and second end bodies  24 ,  26 . According to one embodiment, the central body  22  is a multi-piece assembly including a first half body  52  and a second half body  54 . The first half body  52  includes a pair of tabs  53  which are insertable with corresponding recesses  55  formed on the second half body  54  to facilitate snap-fit engagement between the first and second half bodies  52 ,  54 . The central body  22  includes a first end portion adapted to be cooperatively engageable with the first end body  24  and a second end portion adapted to be cooperatively engageable with the second end body  26 . Referring now specifically to  FIG. 3A , each end portion of the central body  22  includes a protrusion  57  adapted to be received within a corresponding circumferential groove  39  formed on one of the first and second end bodies  24 ,  26  to effectuate engagement between the central body  22  and the first and second end bodies  24 ,  26 . Furthermore, a pair of gaskets or o-rings  59  are insertable within a corresponding groove  41  formed on the first and second end bodies  24 ,  26  to create fluid-tight seal between the central body  22  and the first and second end bodies  24 ,  26 . 
     According to one embodiment, the outer diameter of the o-rings is slightly larger than the inner diameter of the central body  22 , which is collectively defined by the first half body  24  and second half body  26  when the first half body  24  is engaged with the second half body  26 . The larger diameter of the o-rings requires compression of the o-rings when the central body  22  is engaged with the first and second end bodies  24 ,  26 . As can be seen in  FIG. 3A , the top of the o-ring  59  is compressed due to the engagement between central body  22  and end body  30 . The compression of the o-rings  59  results in a compression fit between the central body  22  and end bodies  24 ,  26 . The compression fit makes the device  10  more resistant to disassembly when the device  10  is inadvertently dropped. 
     The central body  22  further includes at least one, and preferably a plurality of windows  65  formed therein, with each window  65  being recessed from an outer surface, and defining a window inner surface  67 . The windows  65  may be elongate and define an ovular shape, a rectangular shape, or any shape known in the art. The windows  65  provide a visual indication as to the volume of the breath sample collected, as will be described in more detail below. 
     According to one embodiment, the central body  22 , first end body  24  and second end body  26  are collectively configured to enable snap-fit engagement therebetween, and thus, additional mechanical fasteners, adhesives, etc., may not be required, which may simplify the overall manufacture and use of the device  10 . Such ease in manufacture may lower the overall production cost, thereby making certain embodiments of the device  10  disposable or intended for one-time use. As such, the user may be assured that when using the device  10 , the collected breath sample may not be contaminated or altered by a previous breath sample. The use of the gaskets or o-rings  59  creates the fluid-tight engagement between the end bodies  24 ,  26  and the central body  22  without the use of adhesives. Furthermore, if adhesives are not used in the device  10 , the breath sample is not tainted via outgassing of vapors or other contaminants, as may be associated with various adhesives. However, it is understood with suitable cleaning during manufacturing or by taking other protective measures known in the art, adhesives may be used in other embodiments of the device  10  without departing from the spirit and scope of the present disclosure. 
     A bladder  56  may be coupled to the first end body  24  and the second end body  26 , with the bladder  56  at least partially defining the internal reservoir  14 . In this regard, the bladder  56  may extend over the internal surface of the central body  22 , with respective end portions of the bladder  56  being captured between the central body  22  and the first and second end bodies  24 ,  26 . The bladder  56  transitions from a deflated configuration to an inflated configuration as the user exhales into the device  10 . In the deflated configuration, a central portion of the bladder  56  is spaced from the inner window surfaces  67  of the central body  22 . When the bladder  56  is completely inflated, the outer surface of the bladder  56  touches the inner window surfaces  67  of the central body  22 , with such contact between the bladder  56  and the inner window surfaces  67  providing a visual indicator to the user that a known volume of breath sample has been collected, which may be critical for diagnostic testing of the collected breath. Furthermore, when the breath sample is subsequently retrieved from the device  10 , at least a portion of the bladder  65  moves away from an inner window surface  67  to provide a visual indication that the breath sample has been extracted from the device  10 . Thus, the movement of the bladder  65  relative to the inner window surfaces  67  of the windows  65  provides an indication to the user that a complete breath sample has been collected, as well as an indication that the breath sample has been subsequently extracted from the device  10 . In order to enhance the visual indicating effect, the window  65  may be clear and the bladder  56  may be formed from a material having a color, such as red, which is easily viewable through the clear window  65 . According to various embodiments, the volume of the internal reservoir  14  when the bladder  56  is completely inflated may range for 50 cc-200 cc, and in one particular embodiment, the volume is 100 cc. The bladder  56  may be formed from Fluorinated Ethylene Propylene (FEP) or other materials known by those skilled in the art. According to one embodiment, the bladder  56  defines a thickness in the range of 0.005-0.002, and more preferably, approximately 0.001, with the thickness being defined as the distance between the inner surface of the bladder  56  and the outer surface of the bladder  56 . 
     The breath capturing device  10  is configured such that a first fluid pathway extends between the inlet  16  and the internal reservoir  14 , a second fluid pathway extends between the internal reservoir  14  and the first outlet  18 , and a third fluid pathway extends between the internal reservoir  14  and the second outlet  20 . The device  10  includes a first valve  58  (e.g., an inlet valve) positioned within the first fluid pathway to restrict fluid flow therealong, a second valve  60  (e.g., an outlet valve) positioned within the second fluid pathway to restrict fluid flow therealong, and a third valve  48  (e.g., an extraction valve) positioned within the third fluid pathway to restrict fluid flow therealong. The first, second, and third valves  58 ,  60 ,  48  are configured to control fluid flow through the device  10  to capture a precise portion of the breath exhaled by the user, particularly, a desired portion of the user&#39;s exhalation phase of breathing. Along these lines, the first and second valves  58 ,  60  are specifically configured and adapted to open in response to prescribed fluid pressures being applied thereto. The third valve  48  is adapted to remain closed during the user&#39;s breathing, and is operative to enable extraction of the breath from the device  10  for testing. 
     According to one embodiment, the first valve  58  is a one-way valve configured to allow fluid flow along the first fluid pathway from the mouthpiece  28  into the internal reservoir  14 . In this regard, the first valve  58  prevents fluid flow from the internal reservoir  14  to the mouthpiece  28 . The first valve  58  includes a first valve body  62  and a first fluid restricting element  64  (e.g., a valve flapper) selectively transitional relative to the first valve body  62  between an open position and a closed position. In the exemplary embodiment, the first valve body  62  is sized and configured to engage with the first end body  24  to create a fluid tight fit therebetween. For instance, the first valve body  62  may frictionally engage with a surface of the first end body  24  to maintain the first valve body  62  in position relative to the first end body  24 . The first valve body  62  defines a first valve body passageway that is in fluid communication with the first fluid passageway when the first valve  58  is mounted to the first end body  24 . The first fluid restricting element  64  includes a flapper which extends across the first valve body passageway when in a closed position, and is capable of moving relative to the first valve body  62  to uncover at least a portion of the first valve body passageway to enable fluid communication through the first valve body  62 . The flapper is biased toward the closed position by a biasing force associated with the first fluid pressure, wherein application of fluid pressure greater than or equal to the first fluid pressure overcomes the biasing force and transitions the flapper to the open position. 
     According to one embodiment, the second valve  60  is similar to the first valve  58 , with the primary distinction being that the biasing force associated with the second valve  60  is greater than that biasing force associated with the first valve  58 , and thus, an increased fluid pressure is required to overcome the biasing force of the second valve  60 . More specifically, the second valve  60  is a one-way valve configured to allow fluid flow along the second fluid pathway from the internal reservoir  14  and through the first outlet  18 . In this regard, the second valve  60  prevents fluid flow into the internal reservoir  14  from the first outlet  18 . The second valve  60  includes a second valve body  66  and a second fluid restricting element  68  (e.g., a valve flapper) selectively transitional relative to the second valve body  66  between an open position and a closed position. In the exemplary embodiment, the second valve body  66  is sized and configured to engage with the second end body  26  to create a fluid tight fit therebetween. For instance, the second valve body  66  may frictionally engage with a surface of the second end body  26  to maintain the second valve body in position relative to the second end body. Along these lines, the second end body  26  may include an annular mounting wall  70  extending from the end wall  40 , with the mounting wall  70  being sized and configured to frictionally engage with the second valve body  66  to create a fluid tight seal therebetween. The second valve body  66  defines a second valve body passageway that is in fluid communication with the second fluid passageway when the second valve  60  is mounted to the second end body  66 . The second fluid restricting element  68  includes a flapper which extends across the second valve body passageway when in a closed position, and is capable of moving relative to the second valve body  66  to uncover at least a portion of the second valve body passageway to enable fluid communication through the second valve body  66 . The flapper is biased toward the closed position by a biasing force associated with the second fluid pressure, wherein application of fluid pressure greater than or equal to the second fluid pressure overcomes the biasing force and transitions the flapper to the open position. 
     The first fluid pressure associated with the first valve  58  and the second fluid pressure associated with the second valve  60  correspond to respective magnitudes to enable a portion of an expiration phase by a human and directed into the inlet  16  to be captured within the internal reservoir  14 . Furthermore, the pressure differential between the first fluid pressure and the second fluid pressure ensures the device  10  captures a known volume of the user&#39;s breath, such as approximately 100 cc. It is understood that the pressure differential may be different depending on the intended use of the device  10 . For instance, the pressure differential may be larger for devices  10  intended for use by adults, and smaller for devices  10  intended for use by children. 
     The third valve  48  is operative to enable selective extraction of the breath captured within the device  10  through the second outlet  20 . In this regard, the third valve  48  is designed to remain closed until the breath is extracted from the device  10 , and thus, the third valve  48  is intended to remained closed while the user breaths into the device  10 . According to one embodiment, the third valve  48  is an umbrella valve having a central mounting nub  72  and a radial body  74  extending radially outward from the central mounting nub  72 . The umbrella valve may be formed from nitrile, or other materials known in the art. The central mounting nub  72  is sized and configured to extend through the third opening  46  formed on the end wall  40 . It is also understood that in other embodiments, the end wall  40  may include a recess, instead of an opening, within which the central mounting nub  72  is mounted. The radial body  74  is sized and configured to extend over the extraction port  20  when the central mounting nub  72  is received within the third opening  46  so as to prevent fluid flow through the extraction port  20 . The radial body  74  is biased toward the end wall  40  to effectively cover the extraction port  20  to prevent inadvertent fluid loss through the extraction port  20 . The radial body  74  is capable of being flexed by an extraction tool  76  when the extraction tool  76  is inserted into the extraction port  20  to extract the breath from the device  10 , as will be described in more detail below. By way of example, and not limitation, an exemplary extraction tool  76  is the Model 4600 zNose™ made by Electronic Sensor Technology, although it is contemplated that other extraction tools known by those skilled in the art may also be used without departing from the spirit and scope of the present disclosure. Although it may be preferable to extract the breath sample using a vacuum extraction device, it is also contemplated that certain embodiments of the device  10  may be configured to enable extraction of the breath sample via a pump mechanism. 
     The device  10  may also include a filter  78  in fluid communication with the third fluid pathway, such that fluid passes through the filter  78  as the fluid flows through the third fluid pathway. The filter  78  may be a moisture filter to reduce the amount of moisture in the tested breath sample, as moisture content in the breath sample when tested may be undesirable. It is contemplated that the filter  78  is not limited to a moisture filter, and that other filters known by those skilled in the art may be employed. The filter  78  may be captured between the mounting wall  70  and the extension wall  42  of the second end body  26 . 
     According to one embodiment, the device  10  may be intended for one-time use, and thus, the device  10  may include an identification element  75  which may be read prior to use to ensure the device  10  has never been used before. The identification element  75  may include a radio-frequency identification (RFID) chip, a barcode, an alphanumeric code, a QR code, or other identifying elements known in the art. The breath testing device  110  may include an identification module  114  capable of reading the identification element  75  on the device  10  and a verification circuit  116  for verifying that the particular device  10  associated with the identification element  75  has never been used before. The identification module  114  may be complimentary to the identification element  75  used on the capturing device, and thus, may include a RFID reader, a barcode scanner, and optical character recognition module, etc. The verification circuit  116  may compare information associated with the identification element  75  with a database  118  of information associated with used devices  10 . If the information matches, the breath testing device  110  may identify the capturing device  10  as having already been used, and will cease retrieving the breath sample from the device  10 . If no match is found, the capturing device  10  may be identified as being a new device and one from which a breath sample may be retrieved. It is contemplated that the identification module  114  may be able to write information back onto the identification element  75 , e.g., writing information back onto an RFID chip. For instance, the information written onto the identification element  75  may indicate that the device  10  has been used, which test was performed on the breath sample collected from the device  10 , as well as information related to the patient, e.g., patient name, vitals, etc. 
     The identification element  75  may also be used for programming the breath testing device  110  to perform a specific breath testing procedure. Along these lines, the testing protocols associated with testing for one disease or condition may be different from the testing protocols associated with testing for another disease or conditions. Different VOCs or different levels of VOCs may be associated with different diseases or conditions, and thus, the breath testing device  110  may need to be specifically programmed to run a specific testing protocol. It is contemplated that the identification element  75  may be associated with a specific testing protocol, such that when the identification element  75  is read, scanned, or otherwise identified by the testing device  110 , a programming circuit  120  within the testing device  110  will implement the specific testing protocols associated with the identified identification element  75 . The implementation of the specific testing protocols may require communication with a CPU  122  or other onboard sensors or testing equipment. 
     With the basic structure of the device  10  described above, the following discussion will focus on an exemplary use of the device  10 . The device  10  is intended to be used to capture a portion of the breath associated with an exhalation phase of a user&#39;s breathing cycle. As can be seen in  FIG. 10 , a typical exhalation phase includes a variable pressure during the course of the exhalation phase, which is divided into three phase portions defined by a prescribed pressure threshold, P. The beginning portion of the exhalation phase having a pressure below the prescribed pressure threshold P is referred to as the first exhalation phase portion, the intermediate portion of the exhalation phase associated with a pressure above the prescribed pressure threshold P is referred to as the second exhalation phase, and the final portion of the exhalation phase associated with a pressure below the prescribed pressure threshold P is referred to as the third exhalation phase. 
     Use of the device  10  begins by placing the end of the mouthpiece within the user&#39;s mouth, and then the user breathing or exhaling into the device  10  at the beginning of the exhalation phase. As the user breaths, the breath exhaled from the user overcomes the first biasing force associated with the first valve  58  and enters the internal reservoir  14 . While the pressure remains below the prescribed pressure threshold P, the second valve  60  remains closed, and the exhaled breath is retained within the internal reservoir  14 . 
     As the user continues exhaling and the pressure crosses the pressure threshold P (e.g., the second exhalation phase portion), the second valve  60  opens to allow the exhaled breath within the device  10  to be exhausted through the first outlet  18 . In this regard, when the pressure is above the pressure threshold P, a continuous fluid pathway is formed through the device  10  from the inlet  16  to the first outlet  18 . In this regard, most of the fluid captured within the device  10  during the first and second exhalation phase portions may be exhausted or vented out of the device  10 , and does not form the breath sample that is ultimately captured within the device  10 . 
     As the user continues through the exhalation phase and the pressure falls below the prescribed pressure threshold P, the second valve  60  closes, and thus, the breath exhaled by the patient is captured within the internal reservoir  14 . When the user completes the exhalation phase, the pressure applied to the device  10  by the user drops to zero, which causes the first valve  58  to transition to from the open position to the closed position. In this regard, the third portion of the exhalation phase of the user&#39;s breath is captured within the device  10 , which results in the pressure within the internal reservoir  14  being elevated relative to the ambient environment. 
     In order to extract the breath sample from the device  10 , the umbrella valve  48  is physically spaced from the second outlet  20  to uncover at least a portion of the second outlet  20 . An extraction tool  76  may be inserted into the second outlet  20  to access the breath sample captured within the device  10 . Since the breath sample is at an elevated pressure, the breath sample may flow out of the device  10  through the second outlet  20  and into the extraction tool  76 . As an alternative, the extraction tool  76  may apply a vacuum to more rapidly extract the breath sample from the device  10 , although, when a vacuum is applied, it is desirable to cover the mouthpiece  28 , either with the end cap  34  or the user&#39;s finger/hand to prevent ambient air from being withdrawn into the extraction tool  76 . 
     Once the breath sample is retrieved by the extraction tool  76 , the breath sample may be analyzed to test for one or more medical conditions. 
     The particulars shown herein are by way of example only for purposes of illustrative discussion, and are not presented in the cause of providing what is believed to be most useful and readily understood description of the principles and conceptual aspects of the various embodiments of the present disclosure. In this regard, no attempt is made to show any more detail than is necessary for a fundamental understanding of the different features of the various embodiments, the description taken with the drawings making apparent to those skilled in the art how these may be implemented in practice.