Abstract:
A breath collection apparatus is provided that includes a facemask to cover the nose and mouth of a patient to direct the breath into a collection bag or collection vial. A valve assembly containing a flexible valve member is provided between the facemask and the collection container to direct a breath sample to the collection container while permitting fresh air to enter the facemask upon inhalation. Between the valve assembly and the collection container is a collection container attachment fitting for engaging the valve assembly with the collection container. The collection container attachment fitting can be a two-piece fitting designed to accommodate a flexible bladder used to accumulate multiple breath samples for subsequent delivery to the collection container.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
       [0001]    The present application derives priority from provisional application 61/011,909 filed on Jan. 22, 2008, which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The present invention relates to breath sampling equipment and in particular to the sampling of air from the lungs of infants. 
         [0004]    2. Description of the Background 
         [0005]    The constituents of expelled air from a patient&#39;s lungs are used for various types of patient diagnoses. To analyze the expelled air, a patient&#39;s breath is collected for analysis. A variety of breath collection systems have been developed that generally include a mouthpiece connected to an inlet for inhalation, an outlet for exhalation, and a valve for diverting the exhaled breath into a sampling assembly. These breath collection systems generally use a sampling canister or collection bag to store or transport the breath samples. 
         [0006]    For example, U.S. Pat. No. 5,140,993 to Opekun, Jr. et al. issued Aug. 25, 1992, shows a breath collection device that includes a flexible plastic bag having a mouthpiece and inlet valve assembly connected adjacent one end of the bag, and a sample transfer assembly connected adjacent the other end of the bag. A hollow needle penetrates a stopper to permit transfer of a breath sample from the bag to a storage device. 
         [0007]    United States Patent Application 20060058696 by Hamilton published Mar. 16, 2006, shows an air sampling apparatus including a bag for containing air and a sensing mechanism coupled to said bag. The self contained sampling and sensing mechanism can be used for visual or other detection of targeted analytes within the breath sample. 
         [0008]    United States Patent Application 20030050567 by Baghdassarian published Mar. 13, 2003, shows a device for collecting alveolar breath. A patient exhales a breath into the inlet of a hollow body. The hollow body has two outlets, with a valve disposed in each outlet. The concentration of a specific gaseous component of expired breath is monitored by a gas concentration monitor as the expired breath passes through the hollow body to determine when alveolar breath is present in the hollow body. When alveolar breath is present in the hollow body, the valve in the second outlet is actuated to an open position to collect the alveolar breath in the collection reservoir affixed to the hollow body at the second outlet. 
         [0009]    U.S. Pat. No. 5,081,871 to Glaser issued Jan. 21, 1992, shows an apparatus for sampling volumetric quantities of human exhaled breath with three conduits in a “Y” or “T” shaped configuration. The free end of one of the conduits is adapted to connect with the mouth of the subject being tested. Another of the conduits is adapted to pass ambient air to the subject, this conduit being provided with a suitable filtering mechanism, and the third of the three conduits supports an appropriate sampling canister for receiving exhaled breath from the subject. The third conduit is also provided with a one-way check valve. 
         [0010]    U.S. Pat. No. 4,190,045 to Bartels issued Feb. 26, 1980, shows a noise reducing exhalation valve and diaphragm for use in exhalation valves of respiratory apparatus to prevent the propagation of harmonic acoustic vibrations. The valve diaphragm employs a cone-shaped central portion. 
         [0011]    U.S. Pat. No. 6,723,056 to Alving et al. issued Apr. 20, 2004, shows a device for the collection, storage, or transport of gas samples using a bag with a reagent chamber. 
         [0012]    U.S. Pat. No. 6,283,122 to Adahan issued Sep. 4, 2001, shows an exhalation valve for a respirator that includes a hollow flow-through body, an air inlet port, and an air outlet port. The inlet port is connected to a source of compressed air or a respirator, and the air outlet port provides air to a patient. The device also includes an exhalation valve. 
         [0013]    United States Patent Application 20040038412 by Yatscoff published Feb. 26, 2004, shows a breath test and kit for the diagnosis of diabetic indications and monitoring glycemic control. 
         [0014]    U.S. Pat. No. 5,327,901 to Delente issued Jul. 12, 1994, shows an apparatus for collecting and storing human breath samples including an elongated, hollow container and a breath delivery device for directing a subject&#39;s breathe into the container. Self sealing tape is disclosed as a closure means that accommodates the insertion of the breath delivery device into the container and that substantially seals the container. 
         [0015]    U.S. Pat. No. 5,467,776 to Hamilton issued Nov. 21, 1995, shows an air sampling device comprising a blow tube connected to a waste air collection bag and an air capture assembly. A person blows a predetermined volume into the blow tube, and after a portion of the air fills the waste bag, a needle pierces a stopper to capture air in a test tube. 
         [0016]    In all of the foregoing examples, healthy adults and older children have no problem filling the collection bag, canister, or vial. Infants and other individuals with shallow or weak breathing, however, have difficulties inflating a collection bag, making it difficult for physicians to collect an adequate sample. Very little attention has been directed to this problem. 
         [0017]    One example is U.S. Pat. No. 5,924,995 to Klein et al. issued Jul. 20, 1999, which explains how a sample of end-tidal air is collected from a child or infant, and notes that the preferred collection method includes the breath collection device described in U.S. Pat. No. 5,140,993 (above), which includes a resuscitation mask with a one-way inlet valve. The infant&#39;s exhaled breath is collected in the collection bag and transferred to an evacuated storage tube, preferably 5 ml in volume. “Older children are capable of blowing directly into the collection bag; or alternatively, they can blow through a straw extending to the bottom of the storage tube when the stopper has been removed. The stopper is replaced after breath collection.” Unfortunately, the referenced valve is not designed for an infant, and capturing an adequate sample remains a problem. Moreover, transferring the infant&#39;s exhaled breath from the collection bag to an evacuated storage tube is cumbersome, and this process leaves the sample susceptible to contamination. 
         [0018]    It would be greatly advantageous to provide an infant breath collector specifically designed for shallow-infant breathing that is both easy for an infant to expel an adequate sample and easy for a physician to collect an adequate sample. 
       SUMMARY OF THE INVENTION 
       [0019]    In accordance with exemplary embodiments of the present invention, an infant breath collector is provided that compensates for shallow-infant breathing. The breath collector includes a facemask that covers both the nose and mouth of the infant and a combination inhalation and exhalation valve coupled to the facemask to permit the inhalation of fresh air through the mask and to direct exhaled air to a collection container, such as a collection bag or collection vial. The combination inhalation and exhalation valve includes an internal diaphragm for admitting fresh air through radial vents and for directing exhaled air centrally out through a conduit to a collection bag. The infant breath collector can also include a polyethylene or similar polymer film bladder coupled between the valve and the collection container using a two-piece attachment fitting. In one embodiment, the attachment fitting is a multi-purpose fitting. The multipurpose fitting includes both a threaded collar for coupling to a vacutainer-type collection vial and a friction or compression fitting extending coaxially outward with the threaded collar for coupling to a breath collection bag such as the Breath Tek™ urea breath test (UBit®) collection bag commercially available from the Meretek Diagnostics group of Otsuka America Pharmaceutical, Inc. of Rockville, Md. Alternatively, the collection container attachment fitting includes either the threaded collar or the compression fitting. In one embodiment, both the collar and fitting are ported. In one embodiment, the collection container attachment fitting is coupled directly to the combination inhalation and exhalation valve. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0020]      FIG. 1  is a plan view of an embodiment of a breath collection system in accordance with the present invention; 
           [0021]      FIG. 2  is a perspective view of an embodiment of a facemask, valve assembly, and collection container attachment fitting; 
           [0022]      FIG. 3  is a top view of an embodiment of the collection container attachment fitting; 
           [0023]      FIG. 4  is a bottom view of the embodiment of the collection container attachment fitting of  FIG. 3 ; 
           [0024]      FIG. 5  is a side view of the embodiment of the collection container attachment fitting of  FIG. 3 ; 
           [0025]      FIG. 6  is a cross-section view through line  6 - 6  of  FIG. 5 ; 
           [0026]      FIG. 7  is an enlarged view of section A of  FIG. 6 ; 
           [0027]      FIG. 8  is a cut-away perspective view of an embodiment of the valve assembly; 
           [0028]      FIG. 9  is a cross-section view of an embodiment of the valve assembly; 
           [0029]      FIG. 10  is a top view of an embodiment of the flexible valve member of the valve assembly; 
           [0030]      FIG. 11  is a cross-section view through line  11 - 11  of  FIG. 10 ; 
           [0031]      FIG. 12  is a cross-section view through line  12 - 12  of  FIG. 10 ; 
           [0032]      FIG. 13  is an enlarged view of section A of  FIG. 12 ; 
           [0033]      FIG. 14  is a top view of another embodiment of the flexible valve member with the exhalation valve removed; 
           [0034]      FIG. 15  is a cross-section view of the flexible valve member of  FIG. 14  with the exhalation valve removed; 
           [0035]      FIG. 16  is a perspective view of another embodiment of a facemask, valve assembly, and collection container attachment fitting for using both collection bags and vials; 
           [0036]      FIG. 17  is a top view of an embodiment of the collection container attachment fitting of  FIG. 16 ; 
           [0037]      FIG. 18  is a bottom view of the embodiment of the collection container attachment fitting of  FIG. 16 ; 
           [0038]      FIG. 19  is a side view of the embodiment of the collection container attachment fitting of  FIG. 16 ; 
           [0039]      FIG. 20  is a cross-section view through line  20 - 20  of  FIG. 19 ; 
           [0040]      FIG. 21  is an enlarged view of section A of  FIG. 20 ; 
           [0041]      FIG. 22  is a perspective view of another embodiment of the breath collection apparatus of the present invention using a bladder; 
           [0042]      FIG. 23  is a side view of an embodiment of the bladder; 
           [0043]      FIG. 24  is perspective view of an embodiment of a facemask, valve assembly, and two-piece collection container attachment fitting; 
           [0044]      FIG. 25  is a cut-away perspective view of the embodiment of  FIG. 24  with bladder attached; 
           [0045]      FIG. 26  is a cross-section view of the embodiment of a valve assembly and a first and second piece of a two-piece collection container attachment fitting of  FIG. 24 ; 
           [0046]      FIG. 27  is a cut-away perspective view of an embodiment of a second piece of a two-piece collection container attachment fitting of  FIG. 24  with bladder and collection vial attached; 
           [0047]      FIG. 28  is a top view of an embodiment of a second piece of a two-piece collection container attachment fitting of  FIG. 24 ; 
           [0048]      FIG. 29  is a bottom view of the embodiment of a second piece of a two-piece collection container attachment fitting of  FIG. 24 ; 
           [0049]      FIG. 30  is a side view of the embodiment of a second piece of a two-piece collection container attachment fitting of  FIG. 24 ; 
           [0050]      FIG. 31  is a cross-section view through line  31 - 31  of  FIG. 30 ; and 
           [0051]      FIG. 32  is an enlarged view of section A of  FIG. 31 . 
       
    
    
     DETAILED DESCRIPTION 
       [0052]    Referring initially to  FIG. 1 , an exemplary embodiment of a breath collection apparatus  100  in accordance with the present invention is illustrated. 
         [0053]    The breath collection apparatus  100  includes a facemask  102  that covers both the mouth and nose of a patient from whom a breath sample is to be collected. The facemask  102  may be sized in accordance with the size or age of the patient, and facemasks of various sizes can be used interchangeably with the breath collection apparatus of the present invention. Suitable arrangements of facemasks are generally known in the art, and the facemask of the present invention includes a rearward coupling for easy attachment to other components of the breath collection apparatus. 
         [0054]    Coupled to the facemask  102  is a valve assembly  104  and a collection container attachment fitting  106 . Suitable materials for the valve assembly  104  and collection container attachment fitting  106  include plastics, polymers, and elastomers, preferably that can be exposed to sterilization procedures. The valve assembly  104  and attachment fitting  106  are varied depending on the application of the breath collection apparatus, i.e., is it being used with an infant or an adult, and the facemask or collection container being used. 
         [0055]    The breath collection apparatus  100  also includes a collection container arranged to accept the breath of the patient. The collection container may be a collection bag  112 , as illustrated in  FIG. 1 , or a collection vial. Suitable bags are known and available in the art and include the Breath Tek™ urea breath test (UBit®) collection bag commercially available from the Meretek Diagnostics group of Otsuka America Pharmaceutical, Inc. of Rockville, Md. The collection bag  112  includes a fill port  108  having a one-way valve (not shown) that allows sample air to be accumulated within the bag, while preventing accumulated air from escaping. Other suitable collection containers may be used. 
         [0056]      FIGS. 2-7  collectively illustrate the collection container attachment fitting  106  used for coupling the face mask  102  and valve assembly  104  with the collection bag  112 . The collection corwiner attachment fitting  106  includes a valve attachment portion  202 , a collection bag attachment portion  204 , and a central tab  206  between the other two portions. The valve attachment portion  202  and the collection bag attachment portion  204  are generally cylindrical and coaxially aligned to define the outer boundary of a common air passage through which a sample breath is passed from the valve assembly  104  to the collection bag  112 . The collection bag attachment portion  204  has a given diameter for press-fitting into the fill port  108  of a collection bag  112 . In one embodiment, the collection bag attachment portion  204  includes a first portion  208  having a first diameter  702  and a second portion  212  disposed between the first portion  208  and the central tab  206 , having a second diameter  704 . The second diameter  704  is greater than the first diameter  702 . In one embodiment, both diameters are selected to fit within the fill port  108  of the collection bag  112 . To facilitate the insertion of the collection bag attachment portion  204  into the fill port  108 , the first portion  208  includes a beveled or chamfered leading edge  502 . Between the first and second portions of the collection bag attachment portion  204  is an annular ridge  210  that defines an annular groove  504  between the annular ridge  210  and the second portion  212 . The annular ridge  210  and annular groove  504  are arranged to provide locking engagement with mating structures within the fill port  108 . In one embodiment, the annular ridge has a diameter  708  substantially the same and preferably slightly less than the diameter  704  of the second portion  212 . In one embodiment, the annular ridge  210  has a cross-sectional angle that is about 90°  712 , and the annular groove  504  includes an inclined face  714  leading to the second portion  212  that forms an angle  716  of about 30° with the central axis  714  of the collection bag attachment portion  204 . In the illustrated embodiment, the collection bag attachment portion  204  has an overall length  710  of about 0.5 inches. 
         [0057]    As best seen in  FIG. 3 , the central tab  206  includes two identical tapered portions  304 . The tapered portions  304  are symmetrical about both axes of a coordinate system  306  centered along the central axis  714  of the attachment fitting  106 . Each tapered portion  304  tapers on all four sides away from the central axis. In general, the central tab  206  is arranged to allow finger placement while removing or seating the attachment fitting  106  with the fill port  108  and the valve assembly  104 . 
         [0058]    The valve attachment portion  202  is generally cylindrical and has receptacle wall  602 , defining an inner cylindrical cavity  402 , arranged to be press fit over a corresponding post of the valve assembly  104 . In the illustrated embodiment, the valve attachment portion  202  has an outer diameter  506  of about 0.8 to about 0.85 inches and an inner diameter of about 0.69 to about 0.73 inches. In one embodiment, the inner cylindrical cavity  402  has a diameter that decreases from the entrance  610  to the central tab  206 . A shoulder  604  is provided that transitions the receptacle wall  602  to an inner portion  608 , taking the diameter from about 0.7 inches down to from about 0.5 to about 0.6 inches. The inner cylindrical cavity  402  is in communication with the cylindrical passage  302  that passes through the central tab  206  and the collection bag attachment portion  204 . In the illustrated embodiment, the valve attachment portion  202  has an overall length  612  of about 0.5 to about 0.55 inches, approximately the same length as the collection bag attachment portion  204 . 
         [0059]      FIGS. 2 ,  8 , and  9  illustrate an exemplary embodiment of the valve assembly  104  for use in the breath collection apparatus of the present invention. As illustrated in  FIG. 8 , the valve assembly  104  is a combination inhalation and exhalation valve comprising an intake housing  802 , an outlet housing  804 , and a flexible valve member  806 . The intake housing  802  connects with the facemask  102 , or any other suitable mouthpiece. The intake housing  802  includes an inlet  808  adapted for attachment with the facemask  102 . As illustrated, the inlet  808  is cylindrical. In this embodiment, the entire valve assembly  104  is coaxial with the collection container attachment fitting  106 . The intake housing  802  flairs out from the inlet  808  to form a housing body  810  that defines a cavity  812  for accepting the outlet housing  804  and the flexible valve member  806 . The housing body  810  includes a shoulder portion  814  and a lip  816 . The outlet housing  804  fits within the shoulder portion  814  and has a radial flange  820  that contacts the lip  816 . Extending from the lip  816  into the cavity  812  is a tang  818  that extends radially around the lip  816  and is arranged to engage a radial groove in the outlet housing  804  adjacent the radial flange  820 . The tang  818  and radial groove provide locking engagement of the intake housing  802  and outlet housing  804  while still permitting the two housings to be disengaged for access to the flexible valve member  806 . 
         [0060]    In one embodiment, the outlet housing  804  includes a cylindrical outlet  822  defining a central cylindrical passage  826 . The outlet  822  is sized to accommodate the valve attachment portion  202  of the collection container attachment fitting  106 , and in one embodiment, the outlet  822  includes an external taper  824  that corresponds to the taper in the receptacle wall  602  of the valve attachment portion  202 . A radial collar  828  extends from outlet  822  into the central cylindrical passage  826 . The radial collar  828  has a rectangular cross section. The outlet housing  804  includes a plurality of distinct holes  830  disposed radially around the outlet  822 , between the outlet  822  and the radial flange  820 . The size and shape of the holes are selected to provide desired air flow for adequate inhalation by the patient. As shown in  FIG. 8 , the cylindrical outlet  822  does not extend into the cavity  812 , and the holes are generally coplanar with the radial flange  820 . Alternatively as illustrated in  FIG. 9 , the cylindrical outlet  822  extends into the cavity  812  and the holes  830  are not coplanar with the radial flange  820 . The flexible valve member  806  extends into the central passage  826  while covering the plurality of holes  830 . 
         [0061]    Referring to  FIGS. 10-13 , an exemplary embodiment of the valve assembly  104  uses a flexible valve member  806  as illustrated. The valve member  806  preferably is made of silicon rubber and has a wedge or cone with exhalation passage. More specifically, the flexible valve member  806  includes an annular portion  1002  that is cup shaped in cross section and defines the entrance to a central cavity  1106 . The annular portion  1002  tapers in thickness from the central cavity  1106  to the edge. The annular portion  1002  is sized to cover the holes  830  in the outlet housing  804 . The cup shape biases the annular portion  1002  over the holes  830  ( FIG. 9 ). Extending upward from the inner edge of the annular portion  1002  is a cylindrical neck portion  1102  having a general diameter  1202 , which is less than the diameter of the central passage  826  in the area of the radial collar  828 , for insertion into the central passage  826 . A first protrusion  1302  extends radially around the exterior of the neck portion  1102  to define a radial groove  1306  having a rectangular cross section to accommodate the radial collar  828 . Nesting of the radial collar  828  into the radial groove  1306  secures and seals the flexible valve member  806  within the outlet housing  804 . The first protrusion  1302  includes a slanted face  1304  to accommodate passage of the first protrusion  1302  over the radial collar  828 . In general, the flexible valve member  806  is sufficiently flexible to pass easily over the radial collar  828 . A second protrusion  1308  radially extends around the neck portion  1102  on the other side of the radial groove  1306  from first protrusion  1302 . In addition to forming one side of the radial groove  1306 , the second protrusion  1308  acts as a stop to limit the insertion of the flexible valve member  806  into the central passage  826 , which creates an air gap  902  between the center of the annular portion  1002  and the outlet housing  804 . In the illustrated embodiment, flexible valve member  806  includes an “umbrella” check valve (the concave annular portion  1002  resembles an open umbrella). The annular portion  1002  flexes towards the outlet housing  804  to create a tight seal over the holes  830  when the pressure on the face-mask side of annular portion  1002  exceeds the pressure on the outlet-housing side of the annular portion  1002 . This pressure difference occurs during exhalation. The umbrella shape is an improvement over a flat or convex shape that would allow the sealing lip to be forced up and away form the holes  830  rather than sealing tightly. 
         [0062]    In one embodiment, coaxially extending from the neck portion  1102  into the central passage  826  is a duck bill portion  1104  having a pair of opposed concave sides  1110  that meet to define an aperture  1108 . The concave sides  1110  taper in thickness towards the aperture  1108 , and the inwardly concave shape of the sides  1110  biases the aperture  1108  closed. In an alternative embodiment of the flexible valve member  806  illustrated in  FIGS. 14 and 15 , the duck bill portion  1104  has been eliminated, leaving an open central passage  1402 . Otherwise, all of the other components are the same as the previous embodiment. This embodiment should be used with-breath collection bags  112  that contain an inlet check valve, as this check valve prevents the collected breath from being released. This embodiment is more suited to collect breath samples from patients with very shallow or weak breathing. 
         [0063]    Returning to  FIG. 9 and 11 , in operation, breath that is exhaled follows the path indicated by arrow A through the duck bill valve  1104  towards the collection container. The aperture  1108  of the duck bill valve opens under the force of the exhaled breath in the direction of arrow C, which also closes the annular portion  1002  of the flexible valve member  806  over the holes  830 . During inhalation, forces in the direction of arrow D hold the aperture  1108  closed, aided by the concave shape of the duck bill sides  1110 . Fresh air is drawn into the valve assembly  104  in the direction of arrow B through the holes  830  as the annular portion  1002  lifts away. 
         [0064]      FIGS. 16-21  illustrate a breath collection apparatus including a facemask  102 , valve assembly  104 , and alternative embodiment of the collection container attachment fitting  1604 . The valve assembly  104  is as described above. The collection container attachment fitting  1604  is a multi-purpose fitting that includes a valve attachment portion  1606 , which is substantially the same as the previously described embodiment of the valve attachment portion  202  of  FIG. 2 . The collection container attachment fitting  1604  also includes a collection container attachment portion  1608  that is arranged to accommodate a plurality of different collection devices. The illustrated attachment fitting  1604  couples with two different collection containers using a tubular post  2012  for attachment to a collection bag and a threaded collar  2010  for attachment to a collection vial. Although the illustrated attachment fitting  1604  does not include a central tab with extended portions for gripping, a suitable central tab such as the one described above can be included. 
         [0065]    In one embodiment, the valve attachment portion  1606  and the collection container attachment portion  1608  are cylindrical and are arranged coaxially to define a common air passage through which the sample breath is passed from the valve assembly  104  to the collection container. The valve attachment portion  1606  has a cylindrical receptacle wall  2002  that defines an inner cylindrical cavity  1702 . In the illustrated embodiment, the valve attachment portion  1606  has an outer diameter  1902  of about 0.8 to about 0.85 inches and an inner diameter  1904  of about 0.69 to about 0.75 inches. The cylindrical receptacle wall  2002  is sized to be press fit over a corresponding outlet  822  of the valve assembly  104 . In one embodiment, the cylindrical cavity  1702  has a diameter that decreases from the entrance  2004  of the inner cylindrical cavity  1702  towards the collection container attachment portion  1608 . A shoulder portion  2006  transitions the receptacle wall  2002  to an inner portion  2008 , taking the diameter from about 0.7 inches down to from about 0.5 to about 0.6 inches. The inner cylindrical cavity  1702  and in particular the inner portion  2008  are in communication with a cylindrical passage  1704  that runs through the central, cylindrical post  2012 . 
         [0066]    The collection container attachment portion  1608  includes an internally threaded collar  2010  that engages with a corresponding threaded end of a collection vial. A plurality of external nubs  1906  assist with connecting the threaded collar  2010  with the threaded portion of a collection vial. In one embodiment, the collection container attachment portion  1608 , including the threaded collar  2010 , does not spin free of the valve attachment portion  1606 , but in another embodiment, the threaded collar  2010  does spin free of the valve attachment portion  1606 . Disposed within threaded collar  2010  is a vent  2011  that extends to an exterior surface of the collection container attachment portion  1608 . An extension tube  2704  ensures that the “fresh” breath sample arrives at the bottom of vial  2208 , thus flushing out any “old” air in the vial  2208  through vent  2011 . This flushing action assures a good breath sample. The collection container attachment portion  1608  also includes a central cylindrical post  2012  that can be inserted into the fill port  108  of a collection bag  112  and retained in that position by friction. A beveled or chamfered leading edge  2014  is provided to guide insertion of the post  2012  into the fill port  108 . Alternatively, when the attachment fitting  1604  is engaged with a screw-top vial  2208 , the cylindrical post  2012  directs breath samples into the vial  2208 . In one embodiment, the post has a length  2016  of about 0.25 inches and an external diameter  2018  of from about 0.20 to about 0.22 inches. The central cylindrical post  2012  comprises a central passage  1704 . 
         [0067]    Referring to  FIG. 22 , in one exemplary embodiment, the breath collection apparatus includes a flexible bladder  2202 . In the illustrated embodiment, the bladder is spheroidal and made of a thin and very flexible polymer, preferably a polyethylene film. Referring to  FIG. 23 , in one embodiment, the bladder  2202  is formed by heat sealing  2306  two identical sheets of flexible material together along the outer edges. The material may be transparent, translucent, or opaque. The bladder  2202  has two open ends  2304  and a central enlarged section  2308  between the two ends  2304 . In general, the bladder  2202  is symmetrical about two perpendicular axes  2302 . The bladder  2202  allows the person collecting a sample from an infant using a collection vial  2208  to visually confirm that a sufficient volume of breath has been collected. The bladder  2202 , being of very thin flexible material, is used to accumulate a breath sample that passes through the valve assembly  104 . Following visual confirmation, the bladder  2202  is squeezed or some constricting force is applied to fill the vial  2208  with a good, well-mixed breath sample. The vial  2208  is then quickly removed, and a sealing cap, for example, a threaded cap (not shown), with septum is screwed on, and the vial is transported to a laboratory with a mass spectrometer or other instrument capable of analyzing the breath sample. When the cap is screwed on, the vial  2208  is sealed off so the breath sample cannot escape or become diluted with ambient air. 
         [0068]    To accommodate the bladder  2202 , the collection container attachment fitting is a two-piece fitting ( FIG. 22 and 24 ). The two-piece fitting includes a first piece  2204 , disposed between the valve assembly  104  and the bladder  2202 , and a second piece  2206 , disposed between the bladder  2202  and the collection vial  2208 . In one embodiment, the bladder  2202  is secured to the two-piece collection container attachment fitting by a pair of elastic rings  2210 . 
         [0069]      FIGS. 24-26  illustrate exemplary embodiments of the two-piece fitting. In one embodiment, the first piece  2204  includes a valve attachment portion. Suitable arrangements for the valve attachment portion  2402  of the first piece  2204  are the same as described above for the valve attachment portion  202 . The valve attachment portion  2402  is cylindrical and defines an inner central cavity  2606 . The valve attachment portion  2402  press fits over the outlet  822  of the valve assembly  104 . In one embodiment, the valve attachment portion  2402  has an outer diameter of from about 0.8 to about 0.85 inches and an inner diameter of about 0.69 to about 0.75 inches. In another embodiment, the inner cylindrical cavity  2606  has a diameter that decreases from the entrance  2608 . The first piece  2204  also includes a bladder attachment portion  2404  extending from the valve attachment portion  2402 . The bladder attachment portion  2404  is sized to fit within the open end  2304  of the bladder  2202 . The bladder attachment portion  2404  comprises a central passage  2604  that is communication with the cylindrical cavity  2606 . Although illustrated with a 90° bend, the first piece  2204  can be straight. In one embodiment, the bladder attachment portion  2404  includes a radial groove  2602  on an exterior surface. The radial groove  2602  is sized to accommodate an elastic ring  2210 . In one embodiment, the radial groove  2602  has a generally semi-circular cross section. To attach the bladder  2202 , the bladder attachment portion  2404  is inserted into an open end  2304  of the bladder  2202  so that the open end  2304  extends past the radial groove  2602 . An elastic ring  2210  is then seated into the radial groove  2602  to seal the bladder  2202  between the elastic ring  2210  and the bladder attachment portion  2404 . 
         [0070]    Referring to  FIGS. 26 and 27 , the second piece  2206  of the two-piece collection container attachment fitting includes bladder attachment portion  2610  arranged to accept an open end  2304  of the bladder  2202 . In one embodiment, the bladder attachment portion  2610  is cylindrical and includes a radial groove  2612  on an exterior surface. The radial groove  2612  is sized to seat an elastic rings  2210 . In one embodiment, the radial groove  2612  has a generally semi-circular cross section. The bladder attachment portion  2610  is inserted into an open end  2304  of the bladder  2202 , opposite the other open end  2304  attached to the bladder attachment portion  2404  of the first piece  2204 , a sufficient distance so that the open end  2304  extends past the radial groove  2612 . An elastic ring  2210  is seated in the radial groove  2612  to seal the bladder  2202  between the elastic ring  2210  and the bladder attachment portion  2610 . 
         [0071]    Referring to  FIGS. 26-32 , the second piece  2206  also includes a collection container attachment portion  2614 , coaxially extending from the bladder attachment portion  2610 . As illustrated, the collection container attachment portion  2614  is a multi-purpose fitting that is arranged for attachment to a collection bag  112  or a collection vial  2208 . The collection device attachment portion  2614  includes an internally thread collar  2618  arranged to accept the corresponding threads of a collection vial  2208 . A plurality of external nubs  2706  is provided to connect the threaded collar  2618  to a collection vial  2208 . In one embodiment, the threaded collar  2618  does not spin free of the bladder attachment portion  2610 . Disposed within the threaded collar  2618  is a vent  2620  that extends to an exterior surface of the collection container attachment portion  2614 . An extension tube  2704  ensures that the “fresh” breath sample arrives at the bottom of vial  2208 , thus flushing out any “old” air in the vial  2208  through vent  2620 . The vent  2620  also prevents a suction vacuum from being created when the collection vial  2208  is removed. 
         [0072]    The collection device attachment portion  2614  also includes a central cylindrical post  2622 . The central cylindrical post  2622  is coaxial with the bladder attachment portion  2610 . In one embodiment, the central post  2622  includes a coaxial central extension  2704  that extends a distance into the collection vial  2208 . The central post  2622  press fits within the fill port  108  of a collection bag  112  and retained in that position by friction. A beveled or chamfered leading edge  2624  is provided to guide insertion of the post  2622  into the fill port  108 . In one embodiment, the central post  2622  includes a first portion  3204  having a first diameter  3206  and a second portion  3208  having a second diameter  3210 . The second diameter  3210  preferably is greater than the first diameter  3206 . In one embodiment, central post  2622  has an annular ridge  3212  with a cross sectional angle  3218  that is about 90°, and an annular groove  3214  with an inclined face  3220  leading to the second portion  3208  that forms an angle  3222  of about 30° with the central axis  2616  of the second portion  3208 . In one embodiment, the central post  2622  has an overall length  3202  of about 0.5 inches. When the collection container attachment portion  2614  is engaged with a collection vial  2208 , the central cylindrical post  2622  directs breath samples into the vial  2208 . 
         [0073]    While it is apparent that the illustrative embodiments of the invention disclosed herein fulfill the objectives of the present invention, it is appreciated that numerous modifications and other embodiments may be devised by those skilled in the art. Additionally, feature(s) and/or element(s) from any embodiment may be used singularly or in combination with other embodiment(s) and steps or elements from methods in accordance with the present invention can be executed or performed in any suitable order. Therefore, it will be understood that the appended claims are intended to cover all such modifications and embodiments, which would come within the spirit and scope of the present invention.