Breath condensate sampler and detector and breath/breath condensate sampler and detector

• US 9,357,946 B2
• Filed: 04/15/2010
• Issued: 06/07/2016
• Est. Priority Date: 04/15/2009
• Status: Expired due to Fees

• Current Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Original Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Inventors: Johnson, Bradley N., Joshi, Kanchan, Chang, Ying-Lan, Radtkey, Ray
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): MESSERSMITH, ERIC J
• Application Number:
  US12/761,290
• Publication Number:
  US 20100268106A1
• Time in Patent Office: 2,245 Days
• Field of Search: 600529-543, 4352872-2873
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: B82Y 30/00 Nanotechnology for materials or surface science, e.g. nanocomposites
• CPC Class Codes: G01N 2001/2282 with cooling means
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath

Abstract

The present invention provides a direct sampler and detector for analytes found in exhaled breath condensate. Analytes in the breath condensate are detected instantaneously as they condense prior to reaching the sensor surface or condense directly on the sensor surface. Because the analysis or assay is performed immediately after patient exhalation, analyte stability is significantly improved providing accurate, reliable, consistent, and clinically applicable results. In certain embodiments, combined breath condensate/breath samplers and detectors are provided, enabling multiplexed analysis of condensed and vapor-phase analytes provided in a single sampling session. Breath is collected and directed to one or more subsystems. Within each subsystem, the breath portion is either condensed or prevented from condensing. The technique also allows real-time continuous monitoring, thus allowing immediate feedback to both medical professionals and additional hardware such as ventilators, anesthesia machines, drug infusion systems and cardiac pacemakers.

Claims

1. A portable unit for breath sampling and detecting comprising:

a portable adapter configured to receive an exhaled breath sample from a patient;

a channel in fluid communication with the adapter;

a condenser disposed within the channel to condense water vapor in exhaled breath sample, said condenser comprising a condensation surface;

a portable exhaled breath condensate sensor coupled to or integral with the adapter, configured to detect one or more analytes present in the condensed water vapor, wherein the condensation surface and the exhaled breath condensate sensor are contained in a removable cartridge;

a flow channel disposed between the condensation surface and the exhaled breath condensate sensor; and

a portable gas-phase detector coupled to or integral with the adapter, configured to detect one or more gas-phase analytes in the exhaled breath sample,

wherein the portable adapter, portable exhaled breath condensate sensor and portable gas-phase detector together form the portable unit.

2. The portable unit of claim 1, wherein the exhaled breath condensate sensor is an electrochemical sensor.

3. The portable unit of claim 2, wherein the exhaled breath condensate sensor is an electrochemical sensor comprising a nanostructured sensing element.

4. The portable unit of claim 3, wherein the nanostructured sensing element is a carbon nanotube (CNT).

5. The portable unit of claim 1, wherein the condenser is configured for active cooling.

6. The portable unit of claim 1, wherein the condenser is configured for passive cooling.

7. The portable unit of claim 1, further comprising a thermoelectric device in thermal contact with the condensation surface.

8. The portable unit of claim 1, further comprising cooling channels in thermal contact with the condensation surface.

9. The portable unit of claim 1, wherein the condensation surface is a surface of the exhaled breath condensate sensor.

10. The portable unit of the any claim 1, wherein the condensation surface is a wire mesh.

11. The portable unit of claim 1, wherein the channel bifurcates into first and second sub-channels, the condenser in the first sub-channel and the gas phase detector disposed in the second sub-channel or a branch thereof.

12. The portable unit of claim 1, further comprising a capillary flow channel disposed between the condensation surface and the exhaled breath condensate sensor.

13. The portable unit of claim 1, further comprising a microfluidic flow channel disposed between the condensation surface and the exhaled breath condensate sensor.

14. The portable unit of claim 1, wherein the flow channel is coated with a reagent, and wherein the reagent comprises fluorophores or other indicator dyes provided in a sol gel coating the flow channel.

15. The portable unit of claim 1, further comprising a liquid-detecting sensor configured to detect whether sufficient condensed water vapor is present on the exhaled breath condensate sensor before the exhaled breath condensate sensor detects the one or more analytes present in the condensed water vapor.

16. The portable unit of claim 15, wherein the liquid-detecting sensor comprises contact electrodes on opposing sides of the exhaled breath condensate sensor, configured to help detect whether there is a continuous film of water vapor across the exhaled breath condensate sensor.

17. The portable unit of claim 1, further comprising a metered sample volume for holding the condensed water vapor before delivery to the exhaled breath condensate sensor, wherein the metered sample volume is configured to provide a specific and uniform volume of condensed water vapor to the exhaled breath condensate sensor.

18. The portable unit of claim 17, wherein the metered sample volume comprises a channel having a valve on each end.

19. A portable unit for breath sampling and detecting comprising:

a portable adapter configured to receive an exhaled breath sample from a patient;

a channel in fluid communication with the adapter;

a condenser disposed within the channel to condense water vapor in exhaled breath sample, said condenser comprising a condensation surface;

a portable exhaled breath condensate sensor coupled to or integral with the adapter, configured to detect one or more analytes present in the condensed water vapor;

a flow channel disposed between the condensation surface and the exhaled breath condensate sensor;

a portable gas-phase detector coupled to or integral with the adapter, configured to detect one or more gas-phase analytes in the exhaled breath sample; and

timers that activate one or more of the exhaled breath condensate sensor and gas-phase detector at appropriate time(s),

wherein the portable adapter, portable exhaled breath condensate sensor and portable gas-phase detector together form the portable unit.

20. The portable unit of claim 19, wherein the timers are configured to initiate periodic measurements over time.

21. The portable unit of claim 20, wherein the timers are additionally configured to cause the exhaled breath sample to be condensed or vaporized as needed for the periodic measurements.

22. The portable unit of claim 19, wherein the exhaled breath condensate sensor is an electrochemical sensor comprising a nanostructured sensing element.

23. The portable unit of claim 22, wherein the nanostructured sensing element is a carbon nanotube (CNT).

24. The portable unit of claim 19, wherein the condensation surface is a surface of the exhaled breath condensate sensor.

25. A portable unit for breath sampling and detecting comprising:

a portable adapter configured to receive an exhaled breath sample from a patient;

a channel in fluid communication with the adapter;

a condenser disposed within the channel to condense water vapor in exhaled breath sample, said condenser comprising a condensation surface;

a portable exhaled breath condensate sensor coupled to or integral with the adapter, configured to detect one or more analytes present in the condensed water vapor;

a flow channel disposed between the condensation surface and the exhaled breath condensate sensor;

a portable gas-phase detector coupled to or integral with the adapter, configured to detect one or more gas-phase analytes in the exhaled breath sample; and

a metered sample volume for holding the condensed water vapor before delivery to the exhaled breath condensate sensor, wherein the metered sample volume comprises a well having a monitoring device that detects when the well is full of condensed water vapor, wherein the metered sample volume is configured to provide a specific and uniform volume of condensed water vapor to the exhaled breath condensate sensor, and

wherein the portable adapter, portable exhaled breath condensate sensor and portable gas-phase detector together form the portable unit.

26. The portable unit of claim 25, wherein the exhaled breath condensate sensor is an electrochemical sensor comprising a nanostructured sensing element.

27. The portable unit of claim 26, wherein the nanostructured sensing element is a carbon nanotube (CNT).

28. The portable unit of claim 25, wherein the channel bifurcates into first and second sub-channels, the condenser in the first sub-channel and the gas phase detector disposed in the second sub-channel or a branch thereof.

29. A portable unit for breath sampling and detecting comprising:

a portable adapter configured to receive an exhaled breath sample from a patient;

a channel in fluid communication with the adapter;

a condenser comprising a condensation surface disposed within the channel for condensing water vapor in the exhaled breath sample;

a portable exhaled breath condensate sensor coupled to or integral with the adapter, configured to detect one or more analytes present in the condensed water vapor, wherein the condensation surface is a surface of the exhaled breath condensate sensor such that the exhaled breath sample condenses directly on and is analyzed on the condensation surface of the exhaled breath condensate sensor;

timers that activate one or more of the exhaled breath condensate sensor and gas-phase detector at appropriate time(s); and

a portable gas-phase detector coupled to or integral with the adapter, configured to detect one or more gas-phase analytes in the exhaled breath sample,

wherein the portable adapter, portable exhaled breath condensate sensor and portable gas-phase detector together form the portable unit.

30. The portable unit of claim 29, further comprising a liquid-detecting sensor configured to detect whether sufficient condensed water vapor is present on the exhaled breath condensate sensor before the exhaled breath condensate sensor detects the one or more analytes present in the condensed water vapor.

31. The portable unit of claim 30, wherein the liquid-detecting sensor comprises contact electrodes on opposing sides of the exhaled breath condensate sensor, configured to help detect whether there is a continuous film of water vapor across the exhaled breath condensate sensor.

32. The portable unit of claim 29, wherein the exhaled breath condensate sensor is an electrochemical sensor comprising a nanostructured sensing element.

33. The portable unit of claim 32, wherein the nanostructured sensing element is a carbon nanotube (CNT).

34. The portable unit of claim 29, wherein the channel bifurcates into first and second sub-channels, the condenser in the first sub-channel and the gas phase detector disposed in the second sub-channel or a branch thereof.

35. The portable unit of claim 29, wherein the timers are configured to initiate periodic measurements over time.

36. The portable unit of claim 35, wherein the timers are additionally configured to cause the exhaled breath sample to be condensed or vaporized as needed for the periodic measurements.