BREATH CONDENSATE SAMPLER AND DETECTOR AND BREATH/BREATH CONDENSATE SAMPLER AND DETECTOR

• US 20100268106A1
• Filed: 04/15/2010
• Published: 10/21/2010
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Original Assignee: Nanomix Incorporated (CJY Holdings Ltd.)
• Inventors: Joshi, Kanchan, Johnson, Bradley N., Chang, Ying-Lan, Radtkey, Ray
• Granted Patent: US 9,357,946 B2
• Time in Patent Office: Days
• US Class Current: 600/532
• 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:

an 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;

an exhaled breath condensate sensor configured to detect one or more analytes present in the condensed water vapor; and

a gas-phase detector configured to detect one or more gas-phase analytes in the exhaled breath sample.

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 any of the above claims wherein the condenser is configured for active cooling.

6. The portable unit of any of the above claims wherein the condenser is configured for passive cooling.

7. The portable unit of any of the above claims further comprising a thermoelectric device in thermal contact with the condensation surface.

8. The portable unit of any of the above claims further comprising cooling channels in thermal contact with the condensation surface.

9. The portable unit of any of the above claims wherein the condensation surface and exhaled breath condensate sensor are contained in a removable cartridge.

10. The portable unit of any of the above claims wherein the condensation surface is a surface of the exhaled breath condensate sensor.

11. The portable unit of the any of claims 1-9 wherein the condensation surface is a wire mesh.

12. The portable unit of any of the above claims 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.

13. The portable unit of any of claims 1-9 or 10-12 further comprising a capillary flow channel disposed between the condensation surface and the exhaled breath condensate sensor.

14. The portable unit of any of the above claims further comprising a microfluidic flow channel disposed between the condensation surface and the exhaled breath condensate sensor.

15. The portable unit of claims 13 or 14 wherein a flow channel disposed between the condensation surface and the exhaled breath sensor is coated with a reagent.

21. The method of any of the above claims wherein receiving an exhaled breath sample from a patient comprising receiving a sample produced by no more than five exhalations from the patient.

22. The method of any of the above claims wherein receiving an exhaled breath sample from a patient comprising receiving a sample produced by a single exhalation from the patient.

16. A method of detecting analytes in breath using comprising:

providing a unit for breath sampling and detecting said unit comprising;

an 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 liquid phase detector configured to detect one or more analytes present in the condensed water vapor; and

a gas-phase detector configured to detect one or more gas-phase analytes in the exhaled breath sample.

receiving an exhaled breath sample from a patient;

directing all or a portion of the exhaled breath sample to the condensation surface to form a condensate;

directing all or portion of the exhaled breath sample to the gas-phase detector;

directing the condensate to the liquid phase detector;

detecting the presence or quantity of one or more analytes in the exhaled breath sample with the gas-phase detector; and

detecting the presence or quantity of one or more analytes in the condensate with the liquid phase detector.

17. The method of claim 16 further comprising sending signal information regarding the presence or quantity of one or more analytes in the exhaled breath sample and signal information regarding the presence or quantity of one or more analytes in the condensate to a signal processing unit.

18. The method of claim 17 comprising generating a combined metric of the patient'"'"'s condition, said combined metric generated from signal information regarding the presence or quantity of one or more analytes in the exhaled breath sample and signal information regarding the presence or quantity of one or more analytes in the condensate.

19. The method of claim 18 wherein the combined metric is a ratio of a cysteinyl leukotriene (CysLT) level to airway inflammation.

20. The method of claim 16 wherein the one or more analytes in the exhaled breath sample comprises nitric oxide and the one or more analytes in the condensate comprises LTE4.