Breath and breath condensate analysis system and associated methods

Abstract

A system for collecting an exhaled breath sample and exhaled breath aerosol from a subject includes a condensation chamber having an outer wall defining an interior space. The outer wall has an inlet port and an outlet port therethrough in fluid communication with the interior space. The inlet port is placeable in fluid communication with an exhaled breath sample of the subject. A condensation element is positioned within the condensation chamber interior space and has a shape tapering downwardly toward a bottom tip thereof. A condensation of fluid on the condensation element is enhanced through various elements. A collection area is positioned within the condensation chamber's interior space beneath the condensation element bottom tip. The collection area is for collecting condensate accumulating on an outer surface of the condensation element and dropping from the tip thereof.

1 . A system for collecting an exhaled breath sample from a subject, the system comprising:
 a condensation chamber having an outer wall defining an interior space, the outer wall having an inlet port and an outlet port therethrough in fluid communication with the interior space;   a valve having an inlet, a first outlet, and a second outlet leading into a lumen thereof, the inlet positionable in fluid communication with exhaled breath of the subject, the first outlet positionable in fluid communication with the condensation chamber inlet port;   a shaft configured to alter a fluid pathway through the valve between a sampling orientation wherein the inlet is in fluid communication with the first outlet and a non-sampling orientation wherein the inlet is in fluid communication with the second outlet; and wherein   the fluid pathway is non-parallel to the axial direction of the shaft.   
     
     
         2 . The system recited in  claim 1 , wherein the valve comprises a housing having the inlet and the first and the second outlets therethrough into the lumen, and a spindle integrated with the shaft, the spindle having a depression in an outer surface thereof, wherein in the sampling orientation the depression forms a channel between the inlet and the first outlet, and in the non-sampling orientation the depression forms a channel between the inlet and the second outlet. 
     
     
         3 . The system recited in  claim 2 , further comprising an actuator for rotating the shaft to achieve a movement between the sampling and the non-sampling orientations and wherein the fluid pathway is substantially perpendicular to the shaft. 
     
     
         4 . The system recited in  claim 3 , further comprising a sensor in fluid communication with the valve inlet adapted to measure an indicator of the exhaled breath of the subject comprising end tidal gas, output from the sensor operable to cause the actuator to move between the sampling and non-sampling orientations. 
     
     
         5 . The system recited in  claim 4 , wherein the sensor comprises at least one of a carbon dioxide sensor or an airway flow sensor. 
     
     
         6 . The system recited in  claim 1 , further comprising a heater in thermal communication with the valve, adapted to heat the valve to a temperature greater than a temperature of the subject. 
     
     
         7 . The system recited in  claim 1 , wherein the valve lumen is coated with a coating adapted to substantially prevent adsorption and breakdown of a predetermined analyte in the exhaled breath. 
     
     
         8 . A device for collecting and condensing liquid in an exhaled breath sample from a subject, the device comprising a chamber having an outer wall defining an interior space, the outer wall having an inlet port and an outlet port therethrough in fluid communication with the interior space, the inlet port placeable in fluid communication with an exhaled breath sample of the subject, and an inner surface comprising alternating hydrophobic and hydrophilic regions and shaped to direct a condensed liquid sample toward a condensate analysis element. 
     
     
         9 . A method for collecting an exhaled breath sample from a subject, the method comprising:
 positioning a valve in fluid communication with exhaled breath of the subject;   sensing and measuring an indicator of the exhaled breath of the subject comprising end tidal gas; and   based upon a result of the sensing and measuring step, altering a fluid pathway through the valve between a sampling orientation wherein the inlet is in fluid communication with a first outlet that in turn is in fluid communication with an inlet port of a chamber and a non-sampling orientation wherein the inlet is in fluid communication with a second outlet, the fluid pathway being non-parallel to the axial direction of a shaft.   
     
     
         10 . The method recited in  claim 9 , wherein altering step comprises moving a spindle within the valve, the spindle having a depression in an outer surface thereof, wherein in the sampling orientation the depression forms a channel between the inlet and the first outlet, and in the non-sampling orientation the depression forms a channel between the inlet and the second outlet. 
     
     
         11 . The method recited in  claim 10 , wherein the spindle-moving step comprises rotating the spindle to achieve a movement between the sampling and non-sampling orientations. 
     
     
         12 . The method recited in  claim 11 , wherein the sensing comprises at least one of sensing a carbon dioxide level or sensing an airway flow. 
     
     
         13 . The method recited in  claim 9 , further comprising heating the valve to a temperature greater than a temperature of the subject. 
     
     
         14 . The method recited in  claim 9 , wherein an interior surface of the valve is coated with a coating adapted to substantially prevent adsorption and breakdown of a predetermined analyte in the exhaled breath. 
     
     
         15 . An instrument for collecting an exhaled breath sample from a subject, the instrument comprising:
 a chamber defining an interior space;   a condensation element suspended in the interior space;   a mechanism for altering a fluid pathway through the interior space between a sampling orientation and a non-sampling orientation;   a disposable breath condensate collection element; and   a mechanism for removably inserting the condensate collection element from the interior space for testing at another location.   
     
     
         16 . The instrument of  claim 15 , wherein the chamber further comprises an inlet port and out outlet port in fluid communication with the interior space and the inlet port is located above the outlet port for maximizing a residence time of a sample in the interior space. 
     
     
         17 . The instrument of  claim 15 , wherein the condensation element is adapted for enhancing a condensation of fluid thereon. 
     
     
         18 . The instrument of  claim 15 , wherein the condensation element is shaped to direct condensation towards a tip thereof. 
     
     
         19 . The instrument of  claim 18 , wherein the condensate collection element is located beneath the tip when the condensate collection element is located in the interior space. 
     
     
         20 . The instrument of  claim 15 , wherein the condensate collection element is capable of collecting an analyzable microfluid sample.