Abstract:
A method and device for collecting, storing, shipping, preparing and analyzing condensate derived from the exhaled breath of a user. Using the mouthpiece ( 15 ) of the device ( 10 ), a human subject inhales drawing air through a check valve ( 30 ).

Description:
TECHNICAL FIELD  
       [0001]     The subject invention relates generally to a method and device for determining medical conditions, and, more particularly to a method and device for condensing, storing, transporting, degassing and analyzing exhaled breath.  
       BACKGROUND OF THE INVENTION  
       [0002]     Recent medical research indicates that human airway acidity and ammonia levels may be indicative of several events including the onset of asthmatic symptoms. Furthermore, this research indicates that the acidity measurements taken from a condensed sample of exhaled breath can be correlated to the actual conditions inside the airway.  
         [0003]     Many known devices for collecting condensate from a user&#39;s breath rely on gravity to form a condensate pool from which a sample for testing may be drawn. These types of devices require that condensate droplets become large enough to overcome water&#39;s naturally tendency to stick to the walls of a collecting tube. Then, when the amount of condensate eventually becomes large enough, a risk of loss of collected condensate sample through seepage out of the collection area may arise due to ineffective sealing of the collection area. Even when an adequate condensate sample had been collected, a risk of contamination occurred due to the necessity to transfer the sample from a collecting tube into test tubes or test devices. Moreover, where the collecting tube is not cooled in some way, condensate formation takes an inordinate amount of time. In some cases, the collecting tube is inserted into an ice bucket or may even be separately cooled by refrigeration systems in order to increase the amount and speed of condensate formation. In other cases, use of a Teflon® collecting tube has been tried to make the tube walls more slippery to enhance the speed and amount of condensate collected. All of these arrangements tend to be either expensive, complicated, ineffective, bulky, inefficient or time-consuming to use. In addition, other condensate collecting and testing devices generally do not provide the ability in a single device both to quickly and efficiently collect condensate while also delivering test substances such as gases or liquids into the condensate without contamination. Moreover, such devices are not typically portable and do not lend themselves easily to use by patients in their own homes. Another disadvantage of devices of the prior art is that they usually do not enable patients to collect condensate samples, prepare those collected samples for testing and then also perform certain tests themselves on the samples.  
         [0004]     What is needed is a device and method for condensate collection which solves the problems and shortcoming already described and, in addition, collects a greater amount of condensate from a given amount of exhaled breath in a shorter time than previously possible while also advancing the art by providing a multi-functional valve for use in such a condensate collection device that simultaneously assists in solving several of those problems.  
       SUMMARY OF THE INVENTION  
       [0005]     The present invention relates to a device and method for collecting condensate from air exhaled by a subject user. The device comprises a mouthpiece, a filter housing, a hollow condensate collecting tube, a movable valve inserted within the collecting tube, a cooling sleeve for placement over the collecting tube, means for moving the valve through the collecting tube and a removable airtight cap. In order to practice the method employing the device, the cooling sleeve is cooled to a temperature lower than that of the collecting tube prior to being slid thereover, air is inhaled by a subject user through the mouthpiece and exhaled through the movable valve into the collecting tube. After the passage of between about two and twenty minutes of breathing, the cooling sleeve is removed from around the collecting tube, the movable valve is advanced through the tube thereby wiping away condensate formed on the interior walls of the tube causing that condensate to collect in a pool around the valve. Thereafter, an airtight cap may be placed over the end of the collecting tube nearest the condensate pool in order to seal the collecting tube prior to storage and/or shipment to a testing location. At the test location, the airtight cap is removed and one or more gasses or liquids is introduced into the condensate through the unique structure of the valve as called for by the particular test to be performed on the condensate. In one embodiment of the device, gas is introduced into the condensate in order to remove carbon dioxide and permit the acidity level of the condensate to be reproducibly measured. Testing may be performed after removing samples of the condensate from the collecting tube or by means of a probe placed into contact with the condensate pool or by insertion of chemicals or chemically impregnated strips.  
         [0006]     It is a primary objective of this invention to provide a simple self-contained and portable device for efficiently collecting, storing and shipping condensate derived from the exhaled breath of a subject wherein the wettable components of such a device may be disposable.  
         [0007]     An additional objective of this invention is to provide a method for collecting condensate derived from the exhaled breath of a subject which is fast, simple, efficient and performable by nonprofessional personnel.  
         [0008]     A further objective of this invention is to provide a device and method in which condensate samples collected from the exhaled breath of a user may be both collected and subjected in situ to various laboratory tests, including ones for measuring pH levels, without the risk of contamination by exposure to influences external to a collecting tube.  
         [0009]     A yet additional objective of this invention is to provide a condensate collecting device which may be made available for use in a patient&#39;s home or workplace.  
         [0010]     It is still another objective of this invention to provide a device and multiple methods for removing carbon dioxide from condensate collected from the exhaled breath of a subject preparatory to measuring the acidity of such condensate.  
         [0011]     It is yet a further objective of this invention to provide a multipurpose valve structure having a unique elliptical shape for use within a tube for collecting condensate from the exhaled breath of a subject which makes the collection of condensate more efficient and also assists in preparing the collected condensate for laboratory testing.  
         [0012]     It is another objective of this invention to provide a device for degassing and/or for adding one or more gasses, liquids or other materials to a sample of condensate collected from the exhaled breath of a subject prior to or while performing laboratory tests on that sample.  
         [0013]     A further objective of this invention is to provide a device in which condensate may be collected, stored and transported in a single unit.  
         [0014]     Still another objective of this invention is to provide a condensate collecting device which makes septuple use of a valve within the device for preventing the admission of air from a condensate collecting tube during inhalation, admitting exhaled air into the condensate collecting tube, making airflow turbulent, swiping condensate off the interior walls of the tube, preventing efflux of condensate, retaining the condensate in a pool within the tube and channeling gasses or liquids into the condensate.  
         [0015]     Yet another objective of this invention is to provide a simple and efficient method for deaerating or degassing collected condensate.  
         [0016]     Still a further objective of this invention is to provide a malleable duckbill valve having an elliptical cross-section for placement within a non-malleable tube having a circular cross-section so that a seal is made in the duckbill valve without a pressure gradient across the valve.  
         [0017]     A yet additional objective of this invention is to provide a one-way malleable duckbill valve for placement within a condensate collecting tube which encourages turbulent airflow as a subject&#39;s exhaled breath passes through.  
         [0018]     Another objective of this invention is to provide a hollow duckbill valve permitting a mechanical seal to be obtained between the valve and the nose portion of a probe inserted into the hollow center of the valve.  
         [0019]     Yet a further objective of this invention is to provide a hollow duckbill valve incorporating one or more passageways through which gasses or fluids will flow when the valve is subjected to particular mechanical stresses.  
         [0020]     An additional objective of this invention is to provide a device with built-in protection for passersby against possible release into the atmosphere of microbes from the lungs of the user of the device.  
         [0021]     These and other objects, features and characteristics of the present invention, as well as the methods of operation and functions of the related elements of structure and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims with reference to the accompanying drawings, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]      FIG. 1  is a center cross-sectional view of the device of the invention;  
         [0023]      FIG. 2  is a center cross-sectional view of the individual components of the device of the invention in a disassembled state;  
         [0024]      FIG. 3  is a center cross-section view of the duckbill valve of this invention before insertion into a collecting tube along a plane perpendicular to the walls of a collecting tube;  
         [0025]      FIG. 4  is a center cross-sectional view of the duckbill valve of this invention along line A-A of  FIG. 3 ;  
         [0026]      FIG. 5  is a side view of the duckbill valve of this invention;  
         [0027]      FIG. 6  is a center cross-sectional view of a collecting tube into which a probe has been inserted behind a duckbill valve.  
         [0028]      FIG. 7  is a center cross-sectional view of a collecting tube into which gas has been introduced under pressure to degas/deaerate condensate;  
         [0029]      FIG. 8  is a schematic of equipment used in performing a second method of degassing/deaerating. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0030]     The device of the invention is intended to be used to condense the water normally exhaled in breath by a human subject and to gather this water in such a manner and in such volume that tests may be performed on the condensate. These tests include measuring acidity, ammonia concentration, as well as the concentration of other characteristics, chemicals and compounds of biologic interest. It may be used by an unskilled layperson, then sealed for transport to a laboratory where subsequent analysis may be performed. Alternatively, the device may also function as part of a home- or workplace-diagnostic device constructed to accept the device and perform the required measurements automatically. Additionally, it may be used in any setting without additional devices, by adding chemical reagents or test strips to detect chemical features and compounds of interest.  
         [0031]     For a better understanding of the invention, reference is now made to  FIG. 1  of the drawings. This figure illustrates a center cross-sectional view of invention device  10  in a dormant state prior to use. Device  10  may be assembled manually from several principal components either before use or on site. Mouthpiece  15  may be a generally tubular T-shaped device with three open projections. On one end, mouthpiece  15  has a generally oblong projection  20  designed to be comfortably inserted between a subject user&#39;s lips. The opposite end projection  25  may be generally tubular in shape, is open to the atmosphere and includes a check valve  30  situated nearby for admitting ambient air from the atmosphere through projection  25  into a subject user&#39;s mouth and lungs and for preventing an outflow of air through projection  25  during the exhalation process.  
         [0032]     Projection  35  is sized so as to be removably insertable into one end of optional filter housing  40  and to be retained therein by virtue of friction between the walls of the exterior of projection  35  and the walls of the interior of the end of filter housing  40  into which it is inserted. Alternatively, projection  35  can be placed in direct intimate contact with the inner or outer surface of collecting tube  60 , and retained there by virtue of friction. During exhalation by the subject user, check valve  30  closes and forces exhaled breath to flow through projection  35 .  
         [0033]     Optional filter housing  40  may comprise a tube-like structure open on both ends and having a filter compartment disposed in the approximate middle thereof separating the two openings  45  and  50  of the tube. Opening  45  on one end of filter housing  40  is sized so as to receive projection  35  from mouthpiece  15 . Optional filter housing  40  includes an optional filter assembly  55 . In the preferred embodiment, the filter compartment and filter are circular and have a diameter of approximately four times the diameter of opening  50 , although other configurations and relative dimensions may be used. Different pore size of the filter might be chosen to limit passage of particles to sizes of particular interest. As particle size might relate to site of formation or other features relevant to the airway, this optional filtering is a useful feature. Optional filter assembly  55  in general functions to remove larger particles from exhaled breath prior to its entering collecting tube  60  and, depending on the filter chosen, also serves to prevent egress of infectious particles in the atmosphere during exhalation. This feature protects passersby from microbes possibly release from the lung of a subject during use of the device. The structure of mouthpiece  15  serves a similar function by substantially reducing the number of salivary droplets which enter optional filter housing  40  or collecting tube  60 .  
         [0034]     Collecting tube  60  is a straight plastic tube open on both ends with a circular cross-section and may have a length of between approximately 3 inches and 20 inches, preferably about 8.75 inches, and a diameter of approximately ½ inch and at most approximately 2 inches, preferably about 0.875 inches. With tubes smaller than ½ inch in diameter, exhaling becomes difficult for the subject user, while with tubes larger than 2 inches in diameter, condensation efficiency is low. Regardless of the exact dimension used, the diameter of collecting tube  60  may be slightly smaller than that of opening  50  in filter housing  40 , or alternatively smaller than that of projection  35 , so as to fit retentively within the corresponding neck of filter housing  40  encompassing opening  50  or within projection  35 . Alternatively, the diameter of collecting tube  60  may be slightly larger than that of opening  50 , or projection  35 , so that the neck of filter housing  40  including opening  50 , or alternatively projection  35 , may be securely and retentively inserted inside one end of collecting tube  60 . Collecting tube  60  may also be constructed from other materials such as stainless steel, anodized aluminum, Teflon® and various types of plastics, and functions to collect, condense and store vaporized and aerosolized particles from breath exhaled thereinto.  
         [0035]     The exterior of collecting tube  60  may incorporate a writable surface for subject users to identify samples with an indelible marker or other suitable writing instrument. Alternatively, a label with named fields for information could be used or bar coding or other scannable data with identifying or destination information could be imprinted on collecting tube  60  prior to delivery.  
         [0036]     Duckbill valve  65  is inserted into the lower end of collecting tube  60  a distance of approximately ½ inch and remains in a closed position when the device is not in use. Duckbill valve  65  may be comprised of rubber or rubber-like elastomeric materials, or plastics which approximate or behave as elastomers, and functions to prevent the passage of air from the end  75  of collecting tube  60  exposed to the atmosphere during the inhaling process described below using mouthpiece  15  and to admit breath from a subject user into collecting tube  60  during the exhaling process, also described below. Its structure and function also prevent the condensate collected in collecting tube  60  from escaping during and after the breath condensate collection procedure.  
         [0037]     Cooling sleeve  70  is a hollow tube sized to slide over collecting tube  60  and place the inner walls of cooling sleeve  70  into physical contact or at least close physical proximity with collecting tube  60  shortly prior to and during practice of the method of this invention. Cooling sleeve  70  may be slightly shorter than collecting tube  60  and, when in place, should not extend to a greater height than collecting tube  60 . Cooling sleeve  70  may be constructed of a material such as aluminum or any high specific heat, durable, reusable material which does not deteriorate when wet and tends to retain and maintain a low temperature when cooled. In one preferred embodiment, the cooling sleeve might be a container in which chemicals can be mixed that create an endothermic reaction, thus providing substantial cooling.  
         [0038]     When placed in position surrounding collecting tube  60  as required for practice of the method of this invention, cooling sleeve  70  functions to draw heat from the inner surface of collecting tube  60 , as will be described below, so as to accelerate the condensing process occurring within the tube. In the preferred embodiment, when properly positioned, collecting tube  60  extends on one open end somewhat beyond the corresponding end of cooling sleeve  70  and terminates approximately coequally with the end of cooling sleeve  70  on the other end. Alternatively, collecting tube  60  may extend on the other end beyond the corresponding end of cooling sleeve  70  so as to be insertable into opening  50  of optional filter housing  40 .  
         [0039]      FIG. 2  provides a center cross-sectional view along a center vertical axis of device  10  of all of the principal components of device  10  in a disassembled state from the component positioned vertically the lowest, mouthpiece  15 , to that positioned highest, airtight cap  80 . Airtight cap  80  is provided as part of device  10  for secure, retentive placement over open end  75  of collecting tube  60  after the method of the invention has been practiced but prior to storage and/or shipment of collecting tube  60  to a laboratory for analysis of condensate. Together with normally closed duckbill valve  65 , airtight cap  80  seals the condensate sample within collecting tube  60  and prevents any fluid exchange with matter or air outside of collecting tube  60 . Airtight cap  80  may be formed from malleable plastic or another material, but its composition is not critical to practice of the invention so long as it provides a secure seal with open end  75  when placed thereover. Collecting tube  60 , duckbill valve  65  and airtight cap  80  together form a disposable assembly which may be prepackaged for a single use ensuring no complicated cleaning or contamination issues arise from use of device  10 .  
         [0040]     Duckbill valve  65  is a critical component of device  10 . It is uniformly constructed from rubber or a material with resilient, rubber-like properties.  FIG. 3  represents a cross-sectional view of duckbill valve  65  taken below valve leaves  100 , shown in  FIGS. 4 and 5  below, prior to its insertion into collecting tube  60  along a plane perpendicular to the walls of collecting tube  60  were duckbill valve  65  inserted therein. Note that since collecting tube  60  has a circular cross-section, as indicated by dotted line  85 , one would normally expect duckbill valve  65  to have a correspondingly circular cross-section. However, its cross-section is uniquely elliptical so that, when forced into a circular shape, such as in the circular bore of collecting tube  60 , it will deform disproportionately so as to create a complete seal between the valve leaves  100  of duckbill valve  65 , shown in  FIGS. 4 and 5  below. This structure provides a seal even at zero reverse differential pressure and is dissimilar from duckbill valves known in the art that require pressure gradients to assure complete valve closure. This feature is particularly valuable in this invention since it assists in providing a secure and long-lasting seal to keep condensate inside collecting tube  60  during long-term storage and/or transport.  
         [0041]      FIG. 4  additionally shows a center cross-sectional view of duckbill valve  65  across the center of both leaves  100  of the valve on a plane parallel to the walls of collecting tube  60  along line A-A of  FIG. 3 . Leaves  100  incorporate malleable structures  105  with which they are attached to section  115  of the body of duckbill valve  65 . An opening may be formed along the slit where leaves  100  meet each other. The center of duckbill valve  65  is hollow. Due to the elliptical valve shape constrained in a circular structure, leaves  100  are biased to a closed position along malleable structures  105 . Thus, when a subject user is inhaling, leaves  100  prevent the admission of air into mouthpiece  15  through collecting tube  60 . However, during exhaling, leaves  100  open along the slit where they meet and admit air into collecting tube  60 . The structure of duckbill valve  65  also results in the creation of turbulence during exhalation which helps to improve condensation efficiency along the walls of collecting tube  60 . For example, shallow breathing through an empty collecting tube  60  is not very turbulent. But when shallow breathing is directed through duckbill valve  65 , leaves  100  open only a little , and leaves  100  vibrate, proving that there is turbulent airflow. When heavier breathing at a higher velocity occurs, leaves  100  open further, preventing increased resistance from occurring while still encouraging turbulence.  
         [0042]     During exhalation, particles of airway lining fluid are ripped off the airway wall and carried in the humid airstream out of the body. When the ambient temperature declines below the dew point (i.e. upon egress from the mouth), the gas phase water vapor/water molecules attach themselves onto the small aerosolized particles, enlarging the particles and increasing the chance by inertia that they will strike nearby surfaces such as the interior walls of collecting tube  60 , especially where there is turbulent airflow. Thus, the creation of turbulent airflow by duckbill valve  65  is another important feature since it allows fluid particles to impact the inner surface of collecting tube  60 , encouraging fluid collection.  
         [0043]     Duckbill valve  65  incorporates a notched area around its exterior into which is tightly and sealingly fitted a rubberized Teflon® ring  110  having an exterior diameter just slightly greater than that of the minor axis of the ellipse formed by the footprint of duckbill valve  65  when at rest. Therefore, when ring  110  is in place, it is biased and makes sealing contact with the interior walls of collecting tube  60 . Ring  110  may also be composed of materials other than Teflon® such as polypropylene, so long as it functions in the same way as does the Teflon® ring described. This ring serves three functions. First, it is a wiper which, as discussed below, removes condensation from the interior walls of collecting tube  60  after the subject user has completed exhalation. Second, it maintains the alignment of duckbill valve  65  in an orthogonal orientation to the walls of collecting tube  60 . Finally, it functions as a valve itself as discussed next.  
         [0044]     The lower part of duckbill valve  65  consists of two general sections  115  and  120 . There are one or more hollow passageways  125  running diagonally upward from an initiation point  130  within the interior hollow area of duckbill valve  65  through lower section  120  into the circular notched area formed on the exterior of duckbill valve  65 . Note that only one passageway  125  is required for subsequent degassification or deaeration steps, although as many as ten such passageways may be preferred depending on the circumstances. Also, note that such passages are not circumferential around the valve, so that in a slightly different cross section, they would not be seen at all, revealing that upper section  115  is confluent with lower section  120  throughout most of the valve structure.  
         [0045]     Lower section  120  tends to be stiffer than upper section  115  since there is a greater volume of material in lower section  120  and, unlike section  115 , it is constrained from movement by direct contact with the walls of collecting tube  60 . Thus, when gas pressure is introduced through passageways  125  against Teflon® ring  110 , section  115  has a tendency to deflect allowing the gas to pass around Teflon® ring  110  and into the portion of collecting tube  60  above duckbill valve  65 . First inner ring  135  is a bump-like ridge extending around the hollow inner portion of duckbill valve  65  at approximately at its base. Second inner ring  140  is another bump-like ridge extending around the hollow inner portion of duckbill valve  65  at a point displaced slightly above initiation point  130  of any passageway  125 . The importance of these features will become clear in conjunction with discussion of the degassing of collecting tube  60  discussed below in conjunction with  FIGS. 6 and 7 .  
         [0046]      FIG. 5  shows a side view of duckbill valve  65  along a plane rotated  90  degrees around a vertical axis from the view shown in  FIG. 4 . This represents a side view along the plane represented by the line B-B of  FIG. 3 . As is evident, the valve has a bilateral structural symmetry.  
         [0047]     The method of this invention is practiced after device  10  has been assembled as described above and shown in the drawings. Although not a required assembly step, cooling sleeve  70  may be placed in a freezer for approximately 20 to 30 minutes prior to use since the larger the difference in temperature between the walls of cooling sleeve  70  and collecting tube  60  the faster and more efficiently condensation will occur and the greater the amount of condensate produced will be. It is required, however, that cooling sleeve  70  be somewhat cooler than collecting tube  60  prior to beginning to practice the method so that the condensation process will be enhanced. The cooling sleeve  70  can be cooled to various temperatures depending on need. When chilled to −20 degrees C. or below, for example, the exhaled fluid and vapors collect as frozen solid material on the inside of the collecting tube  60 , a feature advantageous for the assays of compounds unstable in liquid phase water, as would be the case with a cooling sleeve chilled to a somewhat higher temperature. Temperatures obtained in a home refrigerator or home freezer are satisfactory for excellent liquid phase fluid collection for most purposes, including assessing pH. Throughout practice of the method until after installation of airtight cap  80 , it is preferable to keep collecting tube  60  reasonably perpendicular to the ground.  
         [0048]     As the first step in the method, referring again for visual reference to  FIG. 1 , a subject user places projection  20  of mouth piece  15  between his or her lips and inhales. Duckbill valve  65  remains closed due to the bias of flaps  100  and air is admitted into mouthpiece  15  from projection  25  through check valve  30 . The subject user then exhales. The stream of exhaled breath is blocked from egress out of projection  25  by check valve  30  and follows the path of least resistance upward through projection  35  into optional filter housing  40 , through optional filter assembly  55  and into duckbill valve  65  where leaves  100  are caused to separate and open due to the air pressure allowing the exhaled breath to enter collecting tube  60 . When exhalation is complete, leaves  100  return to their naturally biased closed position.  
         [0049]     Due to the temperature differential between the exhaled breath and the air inside and the walls of collecting tube  60 , the temperature of which has been lowered due to the contact or close proximity of collecting tube  60  with cooling sleeve  70 , condensation begins to form on the walls of collecting tube  60  as exhaled breath traverses the length of collecting tube  60 . Due to the force of gravity, some condensate tends to run down the walls of collecting tube  60  to form a pool around Teflon® ring  110  at the base of duckbill valve  65 . Most remains in place as tiny droplets on the inner wall of collecting tube  60 . Meanwhile, the remaining, now dehydrated, exhaled breath is allowed to escape from open end  75  of collecting tube  60  which remains open to the atmosphere. In general, between about two and twenty minutes of breathing will be performed to provide sufficient sample. In preferred embodiments, a set number of breaths, for example ten, will be sufficient.  
         [0050]     While keeping collecting tube  60  perpendicular to the ground and the end of collecting tube  60  containing duckbill valve  65  nearest to the ground, cooling sleeve  70  is slid away from collecting tube  60 . Then, while keeping collecting tube  60  reasonably perpendicular to the ground and the end of collecting tube  60  containing duckbill valve  65  nearest to the ground, optional filter housing  40  and collecting tube  60  are manually pulled apart and disengaged from each other. Alternatively, projection  35  and collecting tube  60  are manually pulled apart, if the filter is not employed.  
         [0051]     A piston and rod combination is provided as an accessory to device  10 . The piston is designed to fit within collecting tube  60  and to be placed into uniform flat contact with the entire bottom surface of duckbill valve  65  after cooling sleeve  70  and collecting tube  60  are separated. The rod may be attached to the piston in advance or after insertion of the piston into collecting tube  60 . Pressure is then exerted against duckbill valve  65  by means of the rod and piston combination moving duckbill valve  65  vertically upwards through the inside of collecting tube  60  towards open end  75  thereof. Due to the wiper action of Teflon® ring  110 , tiny drops of condensate clinging to the walls of collecting tube  60  are collected into a small pool building up around and ahead of Teflon® ring  110 . The rod and piston combination are removed from collecting tube  60  when duckbill valve  65  has been moved to within approximately two inches from open end  75  of collecting tube  60 . At this point, airtight cap  80  is securely and sealably installed over open end  75  so that collecting tube  60  may be stored and/or shipped to another location, such as a laboratory. By moving duckbill valve  65  towards open end  75 , the volume of air within collecting tube  60  is reduced for storage purposes, and the surface area of the condensate which might come into contact with contaminating air is minimized. Alternatively, the movement of duckbill valve  65  within collecting tube  60  can be deferred until after transport. When desired, this piston and rod combination may also serve the additional purpose of providing a degassing mechanism, as discussed below.  
         [0052]     Once sealed collecting tube  60  has arrived at a testing location, which may even be at a subject user&#39;s home or workplace if diagnostic equipment is stationed there, the collected condensate may be subjected to a variety of treatments depending on the assay desired to be undertaken. Where acidity of the condensate is to be tested or of concern, a degassing or deaeration of the condensate is performed. Degassing or deaerification is a purification process which removes carbon dioxide from the condensate and allows for more accurate and stable measurement of acidity or pH levels. Without this deaeration step, the carbon dioxide in air diffuses in and out of the condensate, changing its pH. This can occur simply as the result of a person breathing over the top of collecting tube  60  when it is open. Thus, any gas that does not contain carbon dioxide or another acid may be used for degassing prior to pH measurement including, but not limited to, argon, helium, oxygen or air that has had carbon dioxide removed from it with a carbon dioxide trap. Alternatively, elimination of carbon dioxide could be accomplished chemically by adding an enzyme and substrate that consumes carbon dioxide and a proton (acid) in a one-to-one ratio.  
         [0053]     In order to perform degassing on the condensate in sealed collecting tube  60 , any one of three methods may be used. First, a probe, which may also serve as the piston discussed previously, may be inserted through the bottom open end of collecting tube  60  and advanced until its further progress is blocked by contact with duckbill valve  65  whereupon pressure is exerted until the nose portion of the probe is seated within duckbill valve  65 . Airtight cap  80  should then be removed. Reference is now made to  FIG. 6  where a partial cross-sectional view of collecting tube  60  is shown in which probe  200  has been seated within duckbill valve  65 . The nose portion of probe  200  has a diameter slightly wider than the diameter of first inner ring  135 . In order to seat probe  200 , the nose portion is pushed into the hollow center of duckbill valve  65  until further forward movement is impeded by contact between the wider shoulder portion of probe  200  and lower section  120  of duckbill valve  65 . At this point, first inner ring  135  has been compacted horizontally so as to form a pressure seal around the nose portion of probe  200  below passageway  125 , while second inner ring  140  has also been compacted horizontally to form another pressure seal around the nose portion of probe  200  above passageway  125 .  
         [0054]     Probe  200  includes a hollow, multipath, cylindrical passageway  205  including one or more openings  210  which exit the nose portion of probe  200  at a height equivalent to the location of initiation point  130  within valve  65 . Specifically, the location of openings  210  lies between first inner ring  135  and second inner ring  140  inside valve  65 . Argon or another carbon dioxide-free gas may be introduced under pressure through passageways  205  of probe  200 . As shown in  FIG. 7 , the pressurized gas follows the path indicated by the dotted lines accompanied by arrows. The mechanical pressure seals formed by inner rings  135  and  140  against the nose portion of probe  200  are considerably stronger than the seal produced by ring  110  against the circular notched area formed on the exterior of duckbill valve  65 . Due to the positioning of passageway(s)  125 , they are not subjected to stress and exit duckbill valve  65  at a point where the valve is not subjected to mechanical stress. As a result, the pressurized gas introduced through passageways  205  follows the unstressed portion of duckbill valve  65 , or passageways  125 .  
         [0055]     As explained above, upper section  115  tends to deflect when exposed to pressurized gas thereby creating a passageway for the gas to circumvent Teflon® ring  110  and escape into and bubble through condensate  215  pooled in collecting tube  60 . Carbon dioxide dissolved in condensate diffuses into the bubbles of the carbon dioxide-free gas. After having passed through condensate  215 , the gas, now containing carbon dioxide derived from the condensate is allowed to escape into the atmosphere from collecting tube  60  through now uncapped open end  75 . Argon, being heavier than air, assists in preventing carbon dioxide from the ambient air from recontaminating the sample.  
         [0056]     An alternative structure for duckbill valve  65  could omit ring  110  and hollow passageways  125  and probe  200 . In this case, gas pressure applied into collecting tube  60  below valve  65  by a positive pressure manifold would cause leaves  100  in duckbill valve  65  to open admitting the gas into the condensate pool. The pressure of the gas would prevent condensate from seeping back into the open valve as would the closing bias of leaves  100  when the application of gas pressure terminated. One example of such a manifold would accept the lower end of collecting tube  60 , make an airtight seal with it and hold it in a vertical position while forcing gas into the tube for degassing. The manifold could interface with available gas plumbing or hoses connecting to a source of gas.  
         [0057]     The third method for degassing is shown in schematic form in  FIG. 8 . Pursuant to that method, airtight cap  80  is removed from collecting tube  60  which is then inserted into a device enclosing both ends of the tube. A hard vacuum is applied to both ends of the tube and the area of the tube below the duckbill valve is periodically opened to the atmosphere or to a carbon dioxide-free gas source. This procedure draws the carbon dioxide out of the solution in the condensate and allows it to be removed through the vacuum pump. Open end  75  of collecting tube  60  is placed in manifold  300 , while the opposing end of the tube is placed in manifold  305 . Vacuum pump  310  is attached to open end  75  by means of manifold  300 , while vacuum gauge  315  is attached to the opposing end of collecting tube  60  by means of manifold  305 . Three-way, two-position solenoid valve  320  is connected between vacuum pump  310  and vacuum gauge  315 . An adjustable orifice  325  functioning with solenoid valve  320  is used to regulate the surge of air or other gas into the lower chamber of collecting tube  60 , and a filter  330  is connected to adjustable orifice  325  in order to ensure that no contaminants are introduced into the system. A human may be used to determine when to vent the lower part of collecting tube  60  through manifold  305  based on readings from vacuum gauge  315 . Alternatively, a vacuum transducer coupled to a controller could be substituted for the vacuum gauge to automate the venting of the collecting tube by energizing solenoid valve  320  pursuant to a control algorithm.  
         [0058]     Certain tests might require passing other gases through or adding liquids or solids to the condensate. The same structures and procedures described above may be used to collect, transport, store and otherwise accomplish these tasks. Other tests that might be performed on collected samples include assays for inorganic and organic compounds, including but not limited to amino acids, volatile organic compounds, lipids and lipid oxidation products, armmonia, simple ions such as sodium and chloride, strong and weak acids and bases, surfactant, inflammatory mediators including cytokines and leukotrienes, oxidation and nitration products including hydrogen peroxide and nitrotyrosine, nucleic acids such as DNA and RNA, endotoxin and other microbial products. In addition, it is important to note that the entire cycle of sampling, storage, degassing and much, if not all, of the analysis is done within device  10 . Transfer of fluid to other apparati is not generally required. Furthermore, all wetted parts of device  10  can easily be made disposable to minimize contamination, cleaning, and cost. The device is fully portable and can be used even by small children. In an alternative structure, a filter may be positioned on top of collecting tube  60  to prevent infectious particles from escaping while allowing larger particles to be trapped in collecting tube  60 . Finally, the device and method of this invention may be adapted for animal use in veterinarian applications.  
         [0059]     When the collected condensate sample has been prepared for testing as required, either by degassing or by addition of gas, liquid or another substance, a probe may be inserted through open end  75  to remove a sample of the condensate for testing purposes. Alternatively, the testing can be performed directly within collecting tube  60 . For example, after degassing, a calibrated pH probe attached to a pH meter can be immersed in the collected sample to determine sample pH. The sample may be removed by contact with the probe or by suction action through the probe. In other embodiments, chemicals can be added, or a chemically impregnated reagent strip can be immersed into the sample for colorimetric determination of pH and other characteristics and substances.  
         [0060]     The foregoing invention has been described in terms of the preferred embodiment. However, it will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed method and system without departing from the scope or spirit of the invention. The specification and examples are exemplary only, while the true scope of the invention is defined by the following claims.