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AssigneeOridion Medical 1987 Ltd.
InventorsIlan Ben-Oren, Ephraim Carlebach, Julian Daich, Lewis Colman, Gershon Levitsky, Boaz Givron, Daniel Katzman
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Breath test methods and apparatus for increasing accuracy and reducing the time taken to achieve diagnostically useful results. In order to determine when an increase in isotopic ratio of the exhaled breath is clinically significant, methods are described for the use of a variable and multiple threshold level; for reducing the time taken to determine an accurate baseline level; and for avoiding the effects of oral activity when making measurements. To increase measurement accuracy, methods are described, using the results of the breath tests themselves, of continuous and automatic self-calibration to correct for drifts in the gas spectrometer absorption curves. A method for increasing the spectral stability of cold cathode discharge infra-red light sources for use in breath test instrumentation is described. Calibration checking devices and methods of mandating their use at regular time intervals are described, to ensure maintenance of the accuracy of breath tests.
A method of determining in a breath test, when a change in a measurement of an isotopic ratio of at least one breath sample of a subject is clinically significant, wherein the criterion for said determining varies during said breath test.
A breath test method using at least one threshold level for determining when the isotopic ratio of at least one breath sample shows sufficient deviation from a measurement of the isotopic ratio of at least one previous sample, that a clinically significant result of the breath test may be concluded, wherein said at least one threshold shows variation during said breath test.
A breath test method for determining whether measurements of the change from a baseline of an isotopic ratio in a subject's exhaled breaths, following the effective cessation of oral activity, are such that the presence of a clinically significant state in said subject is indicated, comprising the steps of:
A breath test method for determining when the measured change in isotopic ratio of a breath sample deviates sufficiently from a baseline measurement that a clinically significant result of the breath test may be concluded, wherein said threshold comprises an upper and a lower threshold band of uncertainty, and wherein the extent of this band is dependent on at least one of the parameters selected from the group consisting of the elapsed time of said breath test, the standard deviation of the physiological spread of results, the dynamics of the physiological change in isotopic ratio, the number of points measured in the breath test, the environmental conditions present during the breath test, and the noise and drift levels of the instrument executing the breath test.
A method for determining the reliability of a breath test measurement, as a function of at least one of the criteria selected from the group consisting of the instrument noise and drift level, the standard deviation of the physiological spread of results, the dynamics of the physiological change in isotopic ratio, and the time elapsed since ingestion of a labeled substrate.
A method of calibrating a breath test instrument, by continuous analysis of results of breath tests of a plurality of subjects, without the need for externally supplied calibration means.
A method of calibrating a breath test instrument, by analyzing results obtained on breath samples of a plurality of subjects not showing change of any significance in the isotopic ratios of a specific gas species measured in said samples, for correlation between said isotopic ratios and the concentration of said gas species in said samples.
A method of calibrating a breath test instrument, by analyzing results obtained on a plurality of collected breath samples from one subject for correlation between the isotopic ratios of a specific gas species measured in said samples and the concentrations of said gas species in said samples.
A method of calibrating a breath test instrument, comprising the steps of:
A method of correcting a change in the calibration of a gas analyzer for determining the isotopic ratio between a first isotopic species of samples of a gas and a second isotopic species of said samples of a gas, comprising the steps of:
A method of correcting a change in the calibration of a gas analyzer for determining the isotopic ratio between a first component and a second component of a gaseous sample, comprising the steps of:
A method of calibration of a capnographic probe, operative for measuring input breath waveforms in a breath test instrument, comprising the steps of:
A breath test instrument which monitors changes in an isotopic ratio of a gas in exhaled breath samples of a subject virtually continuously, and determines that said test has a clinically significant outcome in accordance with the ongoing results of said test.
A breath test instrument comprising a signal for indicating that a clinically significant outcome of a breath test has been determined.
A method of ensuring that the correct isotopically labeled substance kit is used for a specific breath test by means of the addition of a marker element to said substance, said marker element being selected to have an immediate and short term effect on the breath test, and the provision within the breath test instrumentation of a detector for said marker element.
A method for determining when the effects of oral activity have subsided during execution of a breath test, by monitoring change in an isotopic ratio in samples of breath collected from a subject following the ingestion of an isotopically labeled substrate, to detect the presence of a meaningful peak over a predefined minimum threshold level occurring in said isotopic ratio, within a time shorter than the time taken to detect the physiological effect of interest in the breath test.
A method, in a breath test procedure, of determining a baseline level for an isotopic ratio of a gaseous species in exhaled breath of a subject before ingestion of an isotopically labeled substrate, comprising the steps of:
A method, in a breath test procedure, of determining a baseline level for an isotopic ratio of a gaseous species in exhaled breath of a subject, before ingestion of an isotopically labeled substrate, comprising the step of measuring at least first and second baseline points.
A breath simulator device for checking the system functionality of a breath test instrument, which provides gas samples to simulate exhaled breaths of a subject.
A system checking device comprising a porous tube which allows preferential diffusion through its wall of one component of a calibrating gas.
A system checking device comprising:
A breath tester incorporating a system checking procedure, operative to ensure that said breath tester is enabled only if a routine mandatory system check is performed after a predetermined number of breath tests.
A system checking device for use with a gas analyzer, comprising:
A system checking device for use with a gas analyzer, comprising:
A system checking device for use with a gas analyzer, comprising:
A calibration checking unit for use with a gas analyzer, comprising:
A kit for system checking a gas analyzer comprising at least one calibration checking unit and a plurality of disposable sampling tubes for each of at least one calibration checking unit.
A kit for system checking a gas analyzer comprising:
A calibration checking unit operative to generate a second calibration material from a first material input thereto.
A breath bringer which changes a characteristic during use.
A method of constructing an improved, electrically excited, gas discharge lamp, whose output is characteristic of spontaneous emission of at least one IR-active gas species to a ground state, comprising the steps of:
A method of constructing an improved electrically excited gas discharge lamp, whose output is characteristic of spontaneous emission of at least one IR-active gas species to a ground state, comprising the steps of:
A method of constructing an improved electrically excited gas discharge lamp, whose output is characteristic of spontaneous emission of at least one IR-active gas species to a ground state, comprising the steps of:
An improved electrically excited gas discharge lamp, whose output is characteristic of spontaneous emission of at least one IR-active gas species to a ground state, comprising:
A method of determining change in isotopic ratio in a plurality of at least a first, a second and a third gaseous sample collected at different points in time, wherein said change in isotopic ratio is determined by measuring the isotopic ratio of said second sample in relation to said first sample, and in relation to said third sample.
A method of reducing the effect of changes in the operating conditions of a gas analyzer on isotopic ratios measured in a series of at least three gaseous samples, by measuring the isotopic ratio of at least one sample in relation to a sample collected before and a sample collected after said at least one sample.
A method of determining change in the isotopic ratio between a first and a second gaseous sample, comprising the steps of:
A method of determining change in the isotopic ratio between a first and a second gaseous sample, comprising the steps of:
A method of determining change in the isotopic ratio between a first and a second gaseous sample, comprising the steps of:
In a breath test, a method of determining change of an isotopic ratio in a plurality of breath samples of a subject, comprising the steps of:
Dependencies are inferred from the claim text.