Breath test analyzer

• US 20010021815A1
• Filed: 01/22/2001
• Published: 09/13/2001
• Est. Priority Date: 02/26/1997
• Status: Active Grant

• Current Assignee: Exalenz Bioscience, Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Oridion BreathID Ltd.
• Inventors: Carlebach, Ephraim, Katzman, Daniel E.
• Granted Patent: US 6,491,643 B2
• Time in Patent Office: Days
• 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 analyzes a first sample collected from at least a first exhaled breath of a patient and a second sample collected from at least a second exhaled breath of the patient for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, by performing a first analyzing of the first sample and a second analyzing of the second sample, at least said second sample being collected from at least one breath exhaled following the patient'"'"'s ingesting said substance, said analyzer providing an indication of a medical condition within a time period following collection of said second sample which is less than the difference in time between collection of said first sample and collection of said second sample.

2. A breath test analyzer according to

claim 1

and comprising:

a breath analysis chamber,

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

a gas analyzer operative to analyze gas from said breath analysis chamber and to conduct said first analyzing of gas exhaled by the patient'"'"'s first breath and said second analyzing of the patient'"'"'s second breath, at least said second breath being exhaled following ingestion by the patient of said isotope labeled substance.

3. A breath test analyzer according to

claim 1

and comprising:

a breath collection chamber,

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber, and

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

4. A breath analyzer according to

claim 1

and wherein said first sample is collected prior to the patient'"'"'ingestation of an isotopically labeled substance, and said second sample is collected following the patient'"'"'s ingestation of said isotopically labeled substance.

5. A breath test analyzer according to

claim 1

, and wherein both of the first and second samples of patient'"'"'s breaths are collected following patient'"'"'s ingestation of said isotopically labeled substance.

18. A breath test analyzer according to

claim 1

and wherein said patient is coupled to a disposable breath input device.

27. A breath test analyzer according to

claim 2

, and wherein said gas analyzer comprises a gas discharge tube gas analyzer.

28. A breath test analyzer according to

claim 2

, and wherein said gas analyzer comprises an infra-red source which emits a discontinuous spectrum.

29. A breath test analyzer according to

claim 1

, and in the results of the analyzing of successive samples are fitted to a curve, and an indication of a medical condition in a patient is determined by inspecting the derivative of said curve.

32. A breath test analyzer according to

claim 3

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

6. A breath test analyzer which analyzes a patient'"'"'s breath for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, said analyzer providing an indication of a medical condition existent in the patient by analyzing at least two successive samples of the patient'"'"'s breath, wherein said at least two successive samples of the patient'"'"'s breath include at least one later sample exhaled following analysis of at least one earlier sample.

7. A breath test analyzer according to

claim 6

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said breath analysis chamber and to conduct analyses of said at least two successive samples of the patient'"'"'s breath, wherein said at least two successive samples of said patient'"'"'s breath include at least one later sample exhaled following analysis of at least one earlier sample.

8. A breath test analyzer which analyzes a sample collected from at least one of a patient'"'"'s exhaled breaths before and after a product of an isotope labeled substance ingested by said patient could be detected in the patient'"'"'s breath, a first analyzing of said sample taking place prior to said product being detectable in said patient'"'"'s breath and a second analyzing of said sample taking place once said product could be detectable in said patient'"'"'s breath, said analyzer providing an indication of a medical condition within a time period following the collection of said second sample which is less than the difference in time between the collection of said first sample and the collection of said second sample.

9. A breath test analyzer according to

claim 8

and comprising:

breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber and to conduct said first analyzing of said first sample prior to receipt of gas exhaled by said patient which could contain a product of an isotope labeled substance ingested by the patient and said second analyzing of said second sample following receipt of gas exhaled by said patient which could contain a product of an isotope labeled substance ingested by the patient.

33. A breath test analyzer according to

claim 9

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

10. A breath test analyzer which analyzes a first sample collected from at least a first exhaled breath of a patient and a second sample collected from at least a second exhaled breath of said patient for the products of an isotope labeled substance ingested by said patient while the patient is coupled to the device.

12. A breath test analyzer according to

claim 10

and wherein the patient is coupled to the device continuously from the analyzing of said first sample to the analyzing of said second sample.

14. A breath test analyzer according to

claim 10

and comprising:

a breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber while the patient is coupled to the device.

34. A breath test analyzer according to

claim 14

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

11. A breath test analyzer which analyzes a first sample collected from at least a first exhaled breath of a patient and a second sample collected from at least a second exhaled breath of said patient for the products of an isotope labeled substance ingested by said patient and provides an indication of a medical condition while the patient is coupled to the device.

13. A breath test analyzer according to

claim 11

and wherein the patient is coupled to the device continuously from the analyzing of said first sample to the analyzing of said second sample.

15. A breath test analyzer according to

claim 11

and comprising:

a breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber and to provide an indication of a medical condition while the patient is coupled to the device.

35. A breath test analyzer according to

claim 15

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

16. A breath test analyzer which analyzes a patient'"'"'s breath for the products of an isotope labeled substance ingested by the patient, and provides an indication of a medical condition while said patient is breathing into the device.

17. A breath test analyzer according to

claim 16

and comprising:

a breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber and to provide an indication of a medical condition while said patient is breathing into the device.

36. A breath test analyzer according to

claim 17

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas place within said breath collection chamber.

50. A breath test analyzer according to

claim 16

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said analysis chamber and to provide an indication of a medical condition while said patient is breathing into the device.

19. A medical sample analyzer which analyzes samples taken from a patient, and wherein the analyzing of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

23. A medical sample analyzer which analyzes samples taken from a patient, according to

claim 19

and comprising a sample input port for receiving samples taken from said patient, and an analyzing apparatus for analyzing said samples, and wherein the analyzing is terminated automatically at a point in time determined by the results of said analyzing of samples.

20. A medical sample analyzer which analyzes samples taken from a patient, and wherein the taking of said samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

24. A medical sample analyzer which analyzes samples taken from a patient, according to

claim 20

and comprising a sample input port for receiving samples taken from said patient, and an analyzing apparatus for analyzing said samples, and wherein the analyzing is terminated automatically at a point in time determined by the results of said analyzing of samples.

21. A breath test analyzer which analyzes samples of a patient'"'"'s breath for isotope labeled product generated in said patient'"'"'s body after ingestion by the patient of an isotope labeled substance, and wherein the analyzing of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

25. A breath test analyzer according to

claim 21

and comprising:

a breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber and wherein the analyzing of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

37. A breath test analyzer according to

claim 25

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

51. A breath test analyzer according to

claim 21

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said breath analysis chamber and wherein the analyzing of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

22. A breath test analyzer which analyzes samples of a patient'"'"'breath for isotope labeled products generated in said patient'"'"'s body after ingestion by the patient of an isotope labeled substance, and wherein the collection of breath samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

26. A breath test analyzer according to

claim 22

and comprising:

a breath collection chamber;

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas from a patient to said breath collection chamber;

a gas conduit for conveying a sample of gas from said breath collection chamber to said breath analysis chamber; and

a gas analyzer operative to analyze a sample of gas in said breath analysis chamber and wherein the collection of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

38. A breath test analyzer according to

claim 26

and wherein said breath analysis chamber and said breath collection chamber are combined, such that the analyzing of said sample of gas takes place within said breath collection chamber.

52. A breath test analyzer according to

claim 22

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said breath analysis chamber and wherein the analyzing of samples from said patient is terminated automatically at a point in time determined by the results of said analyzing of samples.

30. A method of breath testing which analyzes a first sample collected from at least a first exhaled breath of a patient and a second sample collected from at least a second exhaled breath of the patient for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, and comprising the steps of:

performing a first analyzing of the patient'"'"'s first sample;

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

providing an indication of a medical condition within a time period following collection of said second sample which is less than the difference in time between collection of said first sample and collection of said second sample.

31. A method of breath testing which analyzes a patient'"'"'s exhaled breath for the product of an isotope labeled substance ingested by the patient, and comprising the steps of:

performing a first analyzing of a first sample collected from at least a first exhaled breath prior to said product being detectable in said patient'"'"'s breath;

performing a second analyzing of a second sample collected from at least a second exhaled breath once said product is detectable in the patient'"'"'s breath; and

providing an indication of a medical condition within a time period following the collection of said second sample which is less than the difference in time between collection of said first sample and collection of said second sample.

39. A breath test analyzer which analyzes a first exhaled breath of a patient and a second exhaled breath of the patient for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, by performing a first analyzing of the patient'"'"'s first breath and a second analyzing of the patient'"'"'s second breath, at least said second breath being exhaled following the patient'"'"'s ingesting said substance, said analyzer providing an indication of a medical condition within a time period following exhalation of said second breath which is less than the difference in time between exhalation of said first breath and exhalation of said second breath.

40. A breath test analyzer according to

claim 39

and wherein the patient'"'"'s first breath is exhaled prior to the patient'"'"'s ingestation of an isotopically labeled substance, and the patient'"'"'s second breath is exhaled following the patient'"'"'s ingestation of said isotopically labeled substance.

41. A breath test analyzer according to

claim 39

, and wherein both of the patient'"'"'s first and second breaths are exhaled following patient'"'"'s ingestation of said isotopically labeled substance.

42. A breath test analyzer which analyzes a patient'"'"'s exhaled breath before and after a product of an isotope labeled substance ingested by said patient could be detected in the patient'"'"'s breath, a first analyzing of said patient'"'"'s breath taking place prior to said product being detectable in said patient'"'"'s breath and a second analyzing of said patient'"'"'s exhaled breath taking place once said product could be detectable in said patient'"'"'s breath, said analyzer providing an indication of a medical condition within a time period following the exhalation of said second breath which is less than the difference in time between the exhalation of sad first breath and the exhalation of said second breath.

43. A breath test analyzer according to

claim 42

and comprising:

a breath analysis chamber;

a breath inlet conduit for conveying exhaled gas a patient to said breath analysis chamber; and

a gas analyzer operative to analyze gas in said breath analysis chamber and to conduct said first analyzing prior to receipt of gas exhaled by said patient which could contain a product of an isotope labeled substance ingested by the patient and said second analyzing following receipt of gas exhaled by said patient which could contain a product of an isotope labeled substance ingested by the patient.

44. A breath test analyzer which analyzes a first exhaled breath of a patient and a second exhaled breath of said patient for the products of an isotope labeled substance ingested by said patient while the patient is coupled to the device.

46. A breath test analyzer according to

claim 44

and wherein the patient is coupled to the device continuously from the analyzing of said first exhaled breath to the analyzing of said second exhaled breath.

48. A breath test analyzer according to

claim 44

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said breath analysis chamber while the patient is coupled to the device.

45. A breath test analyzer which analyzes a first exhaled breath of a patient and a second exhaled breath of said patient for the products of an isotope labeled substance ingested by said patient and provides an indication of a medical condition while the patient is coupled to the device.

47. A breath test analyzer according to

claim 45

and wherein the patient is coupled to the device continuously from the analyzing of said first exhaled breath to the analyzing of said second exhaled breath.

49. A breath test analyzer according to

claim 45

and comprising:

a breath analysis chamber;

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

a gas analyzer operative to analyze gas in said breath analysis chamber and to provide an indication of a medical condition while the patient is coupled to the device.

53. A method of breath testing which analyzes a first exhaled breath of a patient and a second exhaled breath of the patient for isotope labeled products generated in the patient'"'"'s body after ingestion by the patient of an isotope labeled substance, and comprising the steps of:

performing a first analyzing of the patient'"'"'s first breath;

subsequently performing a second analyzing of the patient'"'"'s second breath, at least said second breath being exhaled following the patient'"'"'s ingesting said substance; and

providing an indication of a medical condition within a time period following exhalation of said second breath which is less than the difference in time between exhalation of said first breath and exhalation of said second breath.

54. A method of breath testing which analyzes a patient'"'"'s exhaled breath for the product of an isotope labeled substance ingested by the patient, and comprising the steps of:

performing a first analyzing of the patient'"'"'s exhaled breath prior to said product being detectable in said patient'"'"'s breath;

performing a second analyzing of the patient'"'"'s exhaled breath once said product is detectable in the patient'"'"'s breath; and

providing an indication of a medical condition within a time period following the exhalation of said second breath which is less than the difference in time between the exhalation of said first breath and the exhalation of said second breath.