Breath analyzer and breath test methods

• US 10,401,318 B2
• Filed: 05/22/2015
• Issued: 09/03/2019
• Est. Priority Date: 03/14/2011
• Status: Active Grant

• Current Assignee: Anastasia Rigas
• Original Assignee: Anastasia Rigas
• Inventors: Rigas, Anastasia
• Primary Examiner(s): Natnithithadha, Navin
• Assistant Examiner(s): Messersmith, Eric J
• Application Number:
  US15/312,877
• Publication Number:
  US 20170191953A1
• Time in Patent Office: 1,565 Days
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0443 Modular apparatus
• CPC Class Codes: A61B 2562/0285 Nanoscale sensors
• 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 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance
• CPC Class Codes: A61B 5/42 Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems A61B1/00, A61B5/4857, A61B5/486, A61B5/4866, A61B5/4869 take precedence
• CPC Class Codes: A61B 5/4233 oesophagus
• CPC Class Codes: A61B 5/4238 stomach
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: G01N 2033/4975 other than oxygen, carbon dioxide or alcohol, e.g. organic vapours
• CPC Class Codes: G01N 27/126 comprising organic polymers
• CPC Class Codes: G01N 2800/06 Gastro-intestinal diseases
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: G01N 33/4975 other than oxygen, carbon dioxide or alcohol, e.g. organic vapours
• CPC Class Codes: G01N 33/84 involving inorganic compounds or pH

Abstract

The present invention provides an improved breath analyzer and breath test method to determine the presence of a gastrointestinal disorder in a subject'"'"'s digestive tract.

Claims

1. A handheld, portable breath analyzer, comprising:

a main body;

a removable mouthpiece, wherein the removable mouthpiece removably attaches to the main body; and

a gas filter, the gas filter being located in either the removable mouthpiece or the main body;

wherein the main body includes a sensor, a processor, a power source and an electrical circuit;

wherein the electrical circuit operably connects the power source to the sensor and connects the sensor to the processor;

wherein the sensor comprises a conductive material and a hydrogen selective material in contact with the conductive material, wherein the hydrogen selective material has a resistivity that increases in response to increased concentration of hydrogen, wherein the hydrogen selective material comprises polyaniline, wherein the polyaniline is doped with a dopant that increases pH sensitivity of the polyaniline, and wherein the polyaniline has a resistivity that increases in response to increased concentration of hydrogen;

wherein the gas filter is configured to remove ammonia from a breath sample exhaled into the removable mouthpiece, and wherein the breath sample is configured to move through the gas filter before coming into contact with the sensor; and

wherein the processor detects resistivity of the sensor and uses the resistivity to calculate a concentration of hydrogen.

2. The breath analyzer of claim 1 wherein the polyaniline has a pH sensitivity of more than 59 mV.

3. The breath analyzer of claim 1 wherein the dopant comprises a protonic acid.

4. The breath analyzer of claim 3 wherein the dopant comprises a protonic acid selected from the group consisting of hydrochloric acid, sulfuric acid, salicylic acid, acetic acid, citric acid, tartaric acid, oxalic acid, malonic acid, succinic acid, glutamic acid, adipic acid, phthalic acid and camphor sulfonic acid.

5. The breath analyzer of claim 4 wherein the dopant consists essentially of hydrochloric acid.

6. The breath analyzer of claim 1 wherein the conductive material comprises a plurality of electrodes.

7. The breath analyzer of claim 6 wherein the plurality of electrodes are interdigitated finger electrodes.

8. The breath analyzer of claim 1 wherein the hydrogen selective material is deposited as a thin film on the conductive material.

9. The breath analyzer of claim 1 further comprising a desiccant, wherein the desiccant is located in either the removable mouthpiece or the main body.

10. The breath analyzer of claim 6 wherein the electrodes are spaced less than 10 μ

m apart.

11. The breath analyzer of claim 1 wherein the conductive material is gold.

12. The breath analyzer of claim 1 wherein the sensor detects hydrogen at levels between 1 ppm and 100 ppm.

13. The breath analyzer of claim 1 wherein the removable mouthpiece includes a one-way valve.

14. The breath analyzer of claim 1 wherein the conductive material is platinum.

15. A breath test method for screening for a gastrointestinal disorder, comprising steps of:

(a) providing a portable, hand-held breath analyzer, wherein the portable, hand-held breath analyzer comprises;

(i) a main body; and

(ii) a removable mouthpiece, wherein the removable mouthpiece removably attaches to the main body,

wherein the main body includes a sensor, a processor, a power source and an electrical circuit, wherein the electrical circuit operably connects the power source to the sensor and connects the sensor to the processor, wherein the sensor comprises a conductive material and a hydrogen selective material in contact with the conductive material, wherein the hydrogen selective material has a resistivity that increases in response to increased concentration of hydrogen, wherein the hydrogen selective material comprises polyaniline, wherein the polyaniline is doped with a dopant that increases pH sensitivity of the polyaniline, and wherein the polyaniline has a resistivity that increases in response to increased concentration of hydrogen, wherein the portable, hand-held breath analyzer further comprises a gas filter, the gas filter being located in either the removable mouthpiece or the main body;

(b) prompting a subject to exhale a fasting breath sample into the removable mouthpiece;

(c) allowing the processor to measure a resistivity of the sensor that occurs when the fasting breath sample contacts the sensor, the gas filter being configured to remove ammonia from the fasting breath sample before the fasting breath sample comes into contact with the sensor; and

(d) designating the subject as having an increased likelihood of having a gastrointestinal disorder if the measured resistivity is above and/or beneath a predetermined value.

16. The breath test method of claim 15 wherein the gastrointestinal disorder is celiac disease.

17. The breath test method of claim 15 wherein the gastrointestinal disorder is non-celiac gluten sensitivity.

18. A breath test method for diagnosing a gastrointestinal disorder, comprising steps of:

(a) providing a portable, hand-held breath analyzer, wherein the portable, hand-held breath analyzer comprises;

(i) a main body; and

(ii) a removable mouthpiece, wherein the removable mouthpiece removably attaches to the main body, wherein the main body includes a sensor, a processor, a power source and an electrical circuit, wherein the electrical circuit operably connects the power source to the sensor and connects the sensor to the processor, wherein the sensor comprises a conductive material and a hydrogen selective material in contact with the conductive material, wherein the hydrogen selective material has a resistivity that increases in response to increased concentration of hydrogen, wherein the hydrogen selective material comprises polyaniline, wherein the polyaniline is doped with a dopant that increases pH sensitivity of the polyaniline, and wherein the polyaniline has a resistivity that increases in response to increased concentration of hydrogen, wherein the portable, hand-held breath analyzer further comprises a gas filter, the gas filter being located in either the removable mouthpiece or the main body;

(b) prompting a subject to exhale a fasting breath sample into the removable mouthpiece;

(c) allowing the processor to measure a resistivity of the sensor that occurs when the fasting breath sample contacts the sensor, the gas filter being configured to remove ammonia from the fasting breath sample before the fasting breath sample comes into contact with the sensor; and

(d) diagnosing the subject as having a gastrointestinal disorder if the measured resistivity is above and/or beneath a predetermined value.

19. The breath test method of claim 18 wherein the gastrointestinal disorder is celiac disease.

20. The breath test method of claim 18 wherein the gastrointestinal disorder is non-celiac gluten sensitivity.