Disposable hand-held device for collection of exhaled breath condensate

Abstract

A breath condensate collection apparatus comprising a central chamber, a breath input assembly, a plunger assembly and a breath condensate collection port. The central chamber has inner and outer side walls with a coolant material sealed in between. The breath input assembly is disposed on the side of the central chamber in fluid communication with the chamber interior. The plunger assembly has a piston, slidably disposed in the chamber, and a handle extending from a first end of the chamber. The collection port is disposed at the second end of the central chamber in fluid communication with the interior of the chamber. Obstructive structures may be arranged in the chamber interior for increasing the surface area on which condensate may form. The apparatus may also include an outlet assembly that may be removed and replaced with a sampling well into which the condensate may be washed with a buffer solution.

What is claimed is:  
     
         1 . A breath condensate collection apparatus comprising: 
 a central chamber having double side walls and first and second opposing ends, wherein the double side walls include an inner side wall and an outer side wall in spaced relationship to one another;    a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;    a breath input assembly disposed on the outside of the outer side wall of the central chamber and penetrating both the inner and outer side walls such that the interior of the breath input assembly is in fluid communication with the interior of the central chamber;    a plunger assembly having a piston and a handle, wherein the piston is slidably disposed in the interior of the central chamber in snug contact with the inner side wall and wherein the handle extends from the first end of the central chamber so as to permit the piston to be moved within the central chamber; and    a breath condensate collection port, disposed at the second end of the central chamber, in fluid communication with the interior of the central chamber.    
     
     
         2 . The breath condensate collection apparatus of  claim 1 , wherein the plunger assembly is adjustable between a fully retracted position and a fully depressed position, and wherein when the plunger is in its fully retracted position, the fluid connection between the breath input assembly and the central chamber lies in between the piston and the second end of the central chamber.  
     
     
         3 . The breath condensate collection apparatus of  claim 2 , wherein the location of the breath input assembly on the outside of the outer side wall of the central chamber is adjacent the first end of the central chamber.  
     
     
         4 . The breath condensate collection apparatus of  claim 3 , wherein the location of the breath input assembly is underneath the central chamber.  
     
     
         5 . The breath condensate collection apparatus of  claim 3 , wherein the central chamber includes an end wall at the second end thereof, and wherein the breath condensate collection port is disposed in the end wall of the central chamber.  
     
     
         6 . The breath condensate collection apparatus of  claim 5 , wherein the piston includes a surface facing toward the second end of the central chamber, wherein a protrusion is disposed on the surface of the piston, and wherein the protrusion is adapted to fit into the breath condensate collection port when the plunger assembly is fully depressed into the central chamber.  
     
     
         7 . The breath condensate collection apparatus of  claim 6 , wherein the breath condensate collection port and the protrusion are each semi-conical in shape.  
     
     
         8 . The breath condensate collection apparatus of  claim 6 , wherein one or more grooves are disposed in the sides of the protrusion to facilitate guiding breath condensate toward the breath condensate collection port.  
     
     
         9 . The breath condensate collection apparatus of  claim 6 , wherein one or more internal passages are disposed in the interior of the protrusion to facilitate guiding breath condensate toward the breath condensate collection port.  
     
     
         10 . The breath condensate collection apparatus of  claim 9 , further comprising a rigid, hollow tube structure extending from one of the internal passages through which fluid from the interior of the protrusion may be directed.  
     
     
         11 . The breath condensate collection apparatus of  claim 2 , wherein the breath condensate collection port is disposed on the outside of the outer side wall of the central chamber adjacent the second end thereof.  
     
     
         12 . The breath condensate collection apparatus of  claim 11 , wherein the breath condensate collection port is disposed on the bottom of the central chamber, the breath condensate collection apparatus further comprising an outlet and an outlet valve disposed on the top of the outer side wall of the central chamber adjacent the second end thereof.  
     
     
         13 . The breath condensate collection apparatus of  claim 12 , further comprising a cap for temporarily sealing the breath condensate collection port.  
     
     
         14 . The breath condensate collection apparatus of  claim 2 , wherein the breath condensate collection apparatus defines a main axis, wherein the breath input assembly includes a mouthpiece and a tube structure connecting the mouthpiece to the side of the central chamber, and wherein the mouthpiece is generally oriented in parallel to the main axis of the breath condensate collection apparatus.  
     
     
         15 . The breath condensate collection apparatus of  claim 2 , further comprising at least one clip, mounted at the first end of the central chamber, for locking the handle of the plunger assembly in a fully depressed position to facilitate transport or handling of the breath condensate collection apparatus until breath condensate collected therein may be removed.  
     
     
         16 . A method of collecting breath condensate, the method comprising: 
 providing a central chamber having double side walls, first and second opposing ends, a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber, and a breath condensate collection port disposed at the second end of the central chamber;    lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;    receiving, in the interior of the central chamber, exhaled breath from a patient, delivered through the inner and outer side walls via a breath input assembly disposed on the outside of the outer side wall of the central chamber;    condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;    expressing condensate, produced during the condensing step, from the central chamber by depressing a plunger assembly through the central chamber, thereby forcing the condensate into the breath condensate collection port; and    aspirating the expressed condensate from the breath condensate collection port for analysis thereof.    
     
     
         17 . The method of  claim 16 , wherein the aspirating step includes aspirating the expressed condensate into a pipette, the method further comprising: 
 transferring the condensate from the pipette to a separate assay well for analysis thereof.    
     
     
         18 . The method of  claim 17 , wherein providing a central chamber includes providing a central chamber having an outlet and outlet valve disposed on the top of the outer side wall of the central chamber adjacent the second end thereof and the breath condensate collection port disposed on the bottom of the central chamber, the method further comprising: 
 temporarily sealing the breath condensate collection port during the receiving and condensing steps.    
     
     
         19 . The method of  claim 17 , wherein providing a central chamber includes providing a central chamber having at least one clip mounted at the first end of the central chamber, the method further comprising: 
 after expressing the condensate by depressing the plunger assembly, locking, via the at least one clip, the handle of the plunger assembly in a fully depressed position to facilitate transport or handling of the breath condensate collection apparatus until aspirating the expressed condensate.    
     
     
         20 . The method of  claim 17 , wherein receiving exhaled breath includes receiving the exhaled breath delivered through the inner and outer side walls via a breath input assembly disposed underneath the central chamber.  
     
     
         21 . A breath condensate collection apparatus comprising: 
 a central chamber having double side walls including an inner side wall and an outer side wall in spaced relationship to one another;    a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;    a breath input assembly, the interior of which is in fluid communication with the interior of the central chamber;    one or more obstructive structures arranged in the interior of the central chamber for increasing the surface area on which condensate may form; and    a breath condensate collection port in fluid communication with the interior of the central chamber.    
     
     
         22 . The breath condensate collection apparatus of  claim 21 , wherein the obstructive structures include grid-like structures.  
     
     
         23 . The breath condensate collection apparatus of  claim 21 , wherein the obstructive structures include discrete geometric structures.  
     
     
         24 . The breath condensate collection apparatus of  claim 23 , wherein the discrete geometric structures include spherical objects.  
     
     
         25 . The breath condensate collection apparatus of  claim 23 , wherein the discrete geometric structures are formed from metal.  
     
     
         26 . The breath condensate collection apparatus of  claim 23 , wherein the discrete geometric structures are formed from glass.  
     
     
         27 . The breath condensate collection apparatus of  claim 21 , wherein the obstructive structures are fixed in place within the interior of the central chamber.  
     
     
         28 . The breath condensate collection apparatus of  claim 21 , wherein the obstructive structures are free-floating within the interior of the central chamber.  
     
     
         29 . The breath condensate collection apparatus of  claim 28 , wherein movement of the obstructive structures is restricted to a particular portion of the central chamber.  
     
     
         30 . The breath condensate collection apparatus of  claim 21 , wherein the location of the breath input assembly is underneath the central chamber.  
     
     
         31 . A method of collecting breath condensate, the method comprising: 
 providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;    lowering the temperature of the coolant material to chill at least the inner walls of the central chamber and the obstructive structures;    receiving, in the interior of the central chamber, exhaled breath from a patient;    condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber and on the obstructive structures; and    removing condensate, produced during the condensing step, from the central chamber.    
     
     
         32 . The method of  claim 31 , wherein the removing step includes washing the condensate from the obstructive structures.  
     
     
         33 . The method of  claim 32 , wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate present in the central chamber.  
     
     
         34 . The method of  claim 32 , wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient exhales into the central chamber for a predetermined period of time.  
     
     
         35 . The method of  claim 32 , wherein the washing step includes adding an amount of liquid to the central chamber, wherein the amount is selected to correspond to the amount of condensate likely to be present in the central chamber after the patient completes a predetermined number of exhalations into the central chamber.  
     
     
         36 . The method of  claim 32 , further comprising the step of removing the obstructive structures from the central chamber before carrying out the washing step.  
     
     
         37 . A method of collecting breath condensate, the method comprising: 
 providing a double-walled central chamber having a removable outlet assembly and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;    lowering the temperature of the coolant material to chill at least the inner walls of the central chamber;    receiving, in the interior of the central chamber, exhaled breath from a patient;    condensing portions of the exhaled breath on the inner surfaces of the inner walls of the central chamber;    removing the outlet assembly and replacing it with a sampling well; and    moving condensate, produced during the condensing step, from the central chamber to the sampling well.    
     
     
         38 . The method of  claim 37 , wherein the step of moving condensate includes washing condensate from the central chamber into the sampling well with a known liquid.  
     
     
         39 . The method of  claim 38 , wherein the step of washing condensate includes: 
 introducing a predetermined quantity of the known liquid into the central chamber;    mixing the predetermined quantity of the known liquid with the condensate; and    draining the known liquid and the condensate from the central chamber into the sampling well.    
     
     
         40 . The method of  claim 39 , wherein the step of removing the outlet assembly includes creating an opening into the central chamber, and wherein the step of introducing includes introducing the known liquid through the opening.  
     
     
         41 . The method of  claim 39 , further comprising: 
 before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.    
     
     
         42 . The method of  claim 38 , wherein the known liquid is a buffer solution.  
     
     
         43 . The method of  claim 42 , wherein the buffer solution is distilled water.  
     
     
         44 . The method of  claim 42 , wherein the buffer solution includes an organic dye to indicate the pH of the solution.  
     
     
         45 . The method of  claim 38 , further comprising: 
 before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.    
     
     
         46 . The method of  claim 38 , further comprising: 
 before replacing the outlet assembly with the sampling well, storing the known liquid in the sampling well.    
     
     
         47 . A method of collecting breath condensate, the method comprising: 
 providing a double-walled central chamber having one or more obstructive structures arranged in the interior thereof and a coolant material sealed between the inner and outer side walls for cooling at least the inner walls of the central chamber;    calibrating the walls and coolant material of the double-walled central chamber such that, when beginning at a predetermined temperature, a chosen number of breaths, received from a typical patient, creates a sufficient amount of breath condensate to be collected on the inner surfaces of the inner walls of the central chamber;    lowering the temperature of the coolant material to the predetermined temperature to chill at least the inner walls of the central chamber;    receiving, in the interior of the central chamber, a plurality of exhalations from a particular patient, wherein the number of exhalations is within a predetermined range established on the basis of the chosen number of breaths;    condensing portions of the exhalations, received from the patient, on the inner surfaces of the inner walls of the central chamber; and    removing condensate, produced during the condensing step, from the central chamber.    
     
     
         48 . The method of  claim 47 , wherein the predetermined range is 10 to 25 breaths, inclusive.  
     
     
         49 . The method of  claim 47 , wherein the predetermined temperature is the temperature of a standard freezer.  
     
     
         50 . The method of  claim 49 , wherein the predetermined temperature is 0° F.