Breath test analyzer

• US 6,491,643 B2
• Filed: 01/22/2001
• Issued: 12/10/2002
• Est. Priority Date: 02/26/1997
• Status: Expired due to Term

• Current Assignee: Exalenz Bioscience, Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Oridion Medical Ltd (Medtronic Plc)
• Inventors: Carlebach, Ephraim, Katzman, Daniel E.
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Astorino, Michael C.
• Application Number:
  US09/767,601
• Publication Number:
  US 20010021815A1
• Time in Patent Office: 687 Days
• Field of Search: 600/529, 600/532, 600/543, 600/300-301, 128/898, 436/164, 73/233
• US Class Current: 600/532
• CPC Class Codes: A61B 2010/0087 Breath samples
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• 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 5/7239 using differentiation including higher order derivatives
• CPC Class Codes: G01N 21/3504 for analysing gases, e.g. multi-gas analysis
• CPC Class Codes: G01N 33/0006 Calibrating gas analysers
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

A breath test analyzer, which analyzes exhaled breaths of a patient for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, where the presence of these isotope labeled products provide an indication of a medical condition in the patient. The analyzer uses a very sensitive infra-red spectrophotometer, which enables it to continuously collect and analyze multiple samples of the patient'"'"'s breath, and process the outputs in real time, while the patient is still connected to the analyzer, such that a definitive result is obtained within a short time, such as the order of a few minutes. The breath test analyzer is sufficiently small that it can be easily accomodated in the office of a physician. The breath test analyzer can be utilized for a number of diagnostic breath tests, according to the isotope labeled substance ingested by the patient and the gases detected in the patient'"'"'s breath.

Claims

1. A breath test analyzer which collects samples of a subject'"'"'s exhaled breath for analysis for a product of an isotope labeled substance ingested by said subject, comprising:

a breath analysis chamber;

a breath inlet conduit for conveying said exhaled breath from said subject to said breath analysis chamber; and

a gas analyzer operative to analyze gas in said breath analysis chamber and to conduct a first analyzing of a first sample collected from at least a first exhaled breath of said subject, and a second analyzing of a second sample collected from at least a second exhaled breath of said subject, at least said second breath being collected following ingestion by the subject of said isotope labeled substance;

wherein said analyzer determines the gastric emptying rate of the subject from a change in the level of said product of an isotope labeled substance ingested by the subject.

2. A breath test analyzer according to claim 1 and wherein said gastric emptying rate is determined in accordance with the results of the ongoing analyses of said samples.

3. A method of breath testing in which samples collected from exhaled breaths of a subject are analyzed by means of an analyzer for a product of an isotopically labeled substance ingested by the subject, and comprising the steps of:

performing a first analyzing of a first sample collected from at least a first exhaled breath of said subject;

performing a second analyzing of a second sample collected from at least a second exhaled breath of said subject, at least said second sample being collected following the subject'"'"'s ingestion of said substance; and

providing an indication of the gastric emptying rate of the subject from a change in the level in said second sample of said product of said isotope labeled substance ingested by the subject.

4. A method of breath testing according to claim 3 and wherein said gastric emptying rate is determined in accordance with the results of the ongoing analyses of said samples.