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 outerwall 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.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A and 1B are cutaway side perspective views of the condensate trap in position for receiving inspired or fresh gas (FIG. 1A) and for channeling the received gas to the analytical device (FIG. 1B).

FIGS. 1C and 1D illustrate two positions of the three-way breath capture valve, with FIG. 1C sampling the end tidal gas and FIG. 1D transmitting the inhalation gas and the exhalation dead space outside the system.

FIG. 2 is a side perspective view of the valve cylinder.

FIG. 3 is a side perspective view of the spindle.

FIG. 4 is a side perspective view of the spindle, valve, and cap assembly with a servo/servo shaft adapter attached thereto.

FIG. 5 is a side perspective exploded view of the assembly.

FIGS. 6A and 6B are exemplary circuit schematics of the breath capture apparatus, with FIG. 6A directed to a servo controller board and FIG. 6B, to a temperature controller board.

FIG. 7 is a flowchart of the breath capture system.

FIG. 8 is a timing diagram for triggering valve rotation.

FIG. 9 is a side perspective view of the valve cap.

FIG. 10 is a side perspective view of the spindle positioned inside the valve.

FIG. 11 is a side perspective view of the spindle, valve, and cap assembly.

FIG. 12 is a side perspective view of the flow sensor.

FIGS. 13A and 13B illustrate the mating of the condensate trap with the housing.

FIG. 14 illustrates an exemplary pattern printed on a Mylar substrate.

FIG. 15 illustrates a pattern printed on cylindrical shells.

FIG. 16 is a schematic illustration of a condensation chamber.

FIG. 17 illustrates the measurement of contact angle.

FIG. 18 is a graph of the volume of condensate collected versus contact angle.

FIG. 19 is a side perspective view of an exemplary condensation element.

FIG. 20 is a side perspective view of an exemplary EBAC collection device, incorporating the condensation element of FIG. 19.

FIG. 21 illustrates the use of the passive exhaled breath collection system.

FIG. 22 is a schematic illustration of a cylindrical collection chamber, partially cut away along the longitudinal axis to display the interior surface.

Claims

1. A system for collecting an exhaled breath sample from a subject 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, the inlet port placeable in fluid communication with an exhaled breath sample of the subject;a condensation element positioned within the condensation chamber interior space, the condensation element having a shape tapering downwardly toward a bottom tip thereof;means for enhancing a condensation of fluid on the condensation element; anda collection area positioned within the condensation chamber interior space beneath the condensation element bottom tip, for collecting condensate accumulating on an outer surface of the condensation element and dropping from the tip thereof.

2. The system recited in claim 1, wherein the condensation-enhancing means comprises a means for cooling the condensation element below ambient temperature.

3. The system recited in claim 2, wherein the condensation element has a space therein in thermal communication with the outer surface, the space adapted for holding a cooling fluid.

4. The system recited in claim 2, wherein the condensation-enhancing means comprises an electronic cooling means in thermal contact with the condensation element.

5. The system recited in claim 1, wherein the condensation-enhancing means comprises the condensation element outer surface, the outer surface comprising alternating hydrophobic and hydrophilic regions, the hydrophilic regions shaped to channel condensate in a substantially vertical direction toward the tip.

6. The system recited in claim 1, wherein the condensation element has a substantially conical shape.

7. The system recited in claim 6, wherein the condensation element conical shape has a bend in a direction substantially facing the inlet port.

8. The system recited in claim 1, wherein the inlet port of the condensation chamber is positioned substantially vertically aligned with and above the outlet port.

9. The system recited in claim 8, wherein the inlet port of the condensation chamber is positioned to direct fluid toward a top of the condensation element, and the outlet port is positioned adjacent a bottom of the condensation chamber.

10. The system recited in claim 6, further comprising a baffle element positioned within and extending into the condensation chamber interior space at a height between the inlet port and the outlet port, for forming a fluid pathway from the inlet port to the condensation element top, downward and between the condensation element and the baffle element, and out the outlet port.

11. The system recited in claim 1, further comprising a sample collection element removably positionable in fluid communication with the collection area, for receiving condensate therefrom, and for storing the received condensate for subsequent analysis.

12. The system recited in claim 1, further comprising a sample collection element removably positionable in fluid communication with the collection area, for receiving condensate therefrom, and wherein the sample collection element comprises means for analyzing the condensate in situ.

13. The system recited in claim 1, wherein the condensation chamber is substantially spherical.

14. A system for collecting an exhaled breath sample from a subject 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; anda 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;means for altering 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.

15. The system recited in claim 14, wherein the valve comprises a housing having the inlet and the first and the second outlets therethrough into the lumen, and the altering means comprises a spindle closely positioned in and movable within the lumen, 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.

16. The system recited in claim 15, wherein the spindle further comprises a shaft substantially perpendicular to the depression, and the altering means further comprises an actuator for rotating the shaft to achieve a movement between the first and the second orientations.

17. The system recited in claim 16, 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 first and the second orientations.

18. The system recited in claim 17, wherein the sensor comprises one of a carbon dioxide and an airway flow sensor.

19. The system recited in claim 14, 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.

20. The system recited in claim 14, wherein the valve lumen is coated with a coating adapted to substantially prevent adsorption and breakdown of a predetermined analyte in the exhaled breath.

21. A device for collecting an exhaled breath sample from a subject 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, 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, the hydrophobic and hydrophilic regions shaped to channel condensate toward the outlet port.

22. A method for collecting an exhaled breath sample from a subject comprising the steps of: placing an inlet port of a condensation chamber in fluid communication with an exhaled breath sample of the subject, the condensation chamber having positioned therein a condensation element, the condensation element having a shape tapering downwardly toward a bottom tip thereof;enhancing a condensation of fluid on the condensation element; andcollecting condensate accumulating on an outer surface of the condensation element and dropping from the tip thereof.

23. The method recited in claim 22, wherein the condensation-enhancing step comprises cooling the condensation element below ambient temperature.

24. The method recited in claim 23, wherein the condensation-enhancing step comprises placing a cooling fluid in thermal communication with the outer surface of the condensation element.

25. The method recited in claim 23, wherein the condensation-enhancing step comprises using an electronic cooling means that has been placed in thermal contact with the condensation element.

26. The method recited in claim 22, wherein the condensation-enhancing step comprises providing the condensation element outer surface that comprises alternating hydrophobic and hydrophilic regions, the hydrophilic regions shaped to channel condensate in a substantially vertical direction toward the tip.

27. The method recited in claim 22, wherein the condensation element has a substantially conical shape.

28. The method recited in claim 27, wherein the condensation element conical shape has a bend in a direction substantially facing the inlet port.

29. The method recited in claim 22, wherein the inlet port of the condensation chamber is positioned substantially vertically aligned with and above the outlet port.

30. The method recited in claim 29, wherein the condensation-enhancing step comprises directing incoming fluid toward a top of the condensation element, and wherein the outlet port is positioned adjacent a bottom of the condensation chamber.

31. The method recited in claim 30, wherein the condensation-enhancing step comprises forming a fluid pathway from the inlet port to the condensation element top, downward and between the condensation element and a baffle element, and out the outlet port, the baffle element positioned within and extending into the condensation chamber at a height between the inlet port and the outlet port.

32. The method recited in claim 22, further comprising the steps of receiving condensate using a sample collection element and storing the received condensate for subsequent analysis.

33. The method recited in claim 22, further comprising the steps of receiving condensate using a sample collection element and analyzing the condensate in situ using analytical device incorporated with the sample collection element.

34. The method recited in claim 22, wherein the condensation-enhancing step comprises providing a condensation chamber that is substantially spherical.

35. A method for collecting an exhaled breath sample from a subject comprising the steps of: positioning a valve inlet 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; andbased 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 condensation chamber and a non-sampling orientation wherein the inlet is in fluid communication with a second outlet.

36. The method recited in claim 35, 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.

37. The method recited in claim 36, wherein the spindle-moving step comprises rotating a shaft of the spindle to achieve a movement between the first and the second orientations.

38. The method recited in claim 37, wherein the sensing step comprises one of sensing a carbon dioxide level and sensing an airway flow.

39. The method recited in claim 35, further comprising the step of heating the valve to a temperature greater than a temperature of the subject.

40. The method recited in claim 35, 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.