Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/082—Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/42—Detecting, measuring or recording for evaluating the gastrointestinal, the endocrine or the exocrine systems
  • A61B5/4216—Diagnosing or evaluating gastrointestinal ulcers
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
  • G01N33/564—Immunoassay; Biospecific binding assay; Materials therefor for pre-existing immune complex or autoimmune disease, i.e. systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, rheumatoid factors or complement components C1-C9
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
  • G01N33/84—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving inorganic compounds or pH
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
  • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
  • A61B2562/0285—Nanoscale sensors
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B5/00—Measuring for diagnostic purposes; Identification of persons
  • A61B5/08—Detecting, measuring or recording devices for evaluating the respiratory organs
  • A61B5/097—Devices for facilitating collection of breath or for directing breath into or through measuring devices
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
  • G01N33/483—Physical analysis of biological material
  • G01N33/497—Physical analysis of biological material of gaseous biological material, e.g. breath
  • G01N2033/4975—Physical analysis of biological material of gaseous biological material, e.g. breath other than oxygen, carbon dioxide or alcohol, e.g. organic vapours
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N27/00—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means
  • G01N27/02—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance
  • G01N27/04—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance
  • G01N27/12—Investigating or analysing materials by the use of electric, electrochemical, or magnetic means by investigating impedance by investigating resistance of a solid body in dependence upon absorption of a fluid; of a solid body in dependence upon reaction with a fluid, for detecting components in the fluid
  • G01N27/125—Composition of the body, e.g. the composition of its sensitive layer
  • G01N27/127—Composition of the body, e.g. the composition of its sensitive layer comprising nanoparticles
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
  • G01N33/0004—Gaseous mixtures, e.g. polluted air
  • G01N33/0009—General constructional details of gas analysers, e.g. portable test equipment
  • G01N33/0027—General constructional details of gas analysers, e.g. portable test equipment concerning the detector
  • G01N33/0036—Specially adapted to detect a particular component
  • G01N33/005—Specially adapted to detect a particular component for H2

Definitions

• the present invention relates to a diagnostic method and breath-testing device for the diagnosis of celiac disease or other gastrointestinal malabsorption in adults and children.
• Celiac disease is defined as a disease of the small bowel caused by a permanent intolerance to gluten. Most common symptoms of the disease are weight loss due to malabsorption, diarrhea, anemia, and growth failure. Celiac disease affects people of all ages and gender. Its incidence is on the rise worldwide due to environmental and genetic factors, currently affecting, on average, 1/300 people (children and adults) in the United States and in other developed countries. Up until recently celiac disease was considered a disease affecting predominantly people of Northern European origin this, however, is changing as cases are now reported in Asia and the Middle East, albeit at a much lower rate.
• Definitive diagnosis of the disease is made on the basis of small bowel biopsies obtained while the patient is on gluten containing diet and after the patient is taken off gluten and free of symptoms. While small bowel biopsy is an invasive diagnostic modality there are other diagnostic methods currently available.
• blood serum can be tested for the presence of D-xylose, a sugar detected in serum one hour after the ingestion of carbohydrates.
• D-xylose test is performed less frequently due to low sensitivity and specificity for the diagnosis of celiac disease and due to the broad use of the more specific antibody diagnostic tests.
• the present invention consists of a novel, inexpensive, non-invasive, point-of-care, handheld, device for the diagnosis of celiac disease using a selective hydrogen gas nanosensor.
• a person, adult or child, suspected of having celiac disease or other type of gastrointestinal malabsorption will provide one fasting breath sample through the mouth piece of the device. No ingestion of carbohydrate substrate is required.
• Figure 1 is a schematic block diagram of a breath analyzer device for the detection of hydrogen in breath according to the invention
• Figure 2a is a scanning electron micrograph in cross-section of ZnO nanowires grown in deposition region at the entrance zone (ratio 0/Zn>l);
• Figure 2b is a top view scanning micrograph of ZnO nanowires grown at the exit zone (ratio 0/Zn ⁇ 1);
• Figure 3 is a graph showing the 3 ⁇ 4 gas response for a lOOnm diameter ⁇ ,, ⁇ NW-based sensor.
• Figure 4 shows electronic circuitry of a device according to the invention.
• the breath analyzer detects the presence of hydrogen in a human breath sample.
• Figure 1 shows a sensor device which consists of a mouth piece, a trap for CO 2 , NH 3 and H 2 0, a hydrogen nanosensor, constant dry air flow and electronics.
• the electronics include an acquisition module, a memory/computation module, and two displays.
• the numerical display provides the concentration.
• the YES/NO display will provide the person with an answer indicating high (above the established for this device threshold) or low (below the established for this device threshold) level of hydrogen in breath.
• a high level will indicate celiac disease or another type of gastrointestinal malabsorption, and a low level will indicate normal gastrointestinal absorption i.e. less likely celiac disease.
• the sensor may be a nanosensor, or may be a hydrogen-selective film available from Giner, Inc., Newton, MA, which it calls a trace gas sensor. (See, www. ginerinc.com.)
• the characteristics of the sensor according to the invention are that 1) it is hydrogen selective; 2) can be ZnO nanowire-based (100 ⁇ in diameter) or other type of hydrogen- selective film or nanosensor; 3) can be a single ZnO nanowire sensor fabricated using focused ion beam (FIB/SEM) instrument (5); and 4) can be capable of operating at room temperature requiring a small pulse UV light to recover.
• FIB/SEM focused ion beam
• Figure 2a is a scanning electron micrograph in cross-section of ZnO nanowires grown in deposition region at the entrance zone (ratio 0/Zn>l).
• Figure 2b is a top view scanning micrograph of ZnO nanowires grown at the exit zone (ratio 0/Zn ⁇ 1 ).
• Figure 3 is a graph showing the IF gas response for a lOOnm diameter ⁇ ,, ⁇ NW-based sensor. The response curves of the individual nanowire-based sensor toward lOppm IF pulses. Before the test the nanowire was preconditioned in a constant dry air flow. An UV pulse is applied after 3 ⁇ 4 is turned off. Lupan O. el al. (5).
• Figure 4 shows the electronic circuitry of the device. Figure 4 shows a sensor, interface circuitry and display.
• a micro-controller ( ⁇ €) contains the Analog-to-Digital Converter memory (SRAM), and an Arithmetic Logic Unit (ALU).
• the V test is a voltage proportional to the resistance of the sensor.
• the sensor will detect hydrogen gas. If one wishes to detect gases other than hydrogen, other sensors could be used. More than one sensor could be incorporated, with a switch to select connection of the sensor to the circuit for the specific gas to be detected.

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Citations (4)

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• 2012
  • 2012-03-14 WO PCT/US2012/029087 patent/WO2012125734A2/en active Application Filing
  • 2012-03-14 EP EP12757976.1A patent/EP2685891A4/de not_active Withdrawn

Patent Citations (4)

Non-Patent Citations (2)

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