Gas analyzer calibration checking device

• US 20050273016A1
• Filed: 08/09/2005
• Published: 12/08/2005
• Est. Priority Date: 06/08/1999
• Status: Active Grant

• Current Assignee: Exalenz Bioscience, Ltd. (Otsuka Holdings Company Limited)
• Original Assignee: Oridion BreathID Ltd.
• Inventors: Ben-Oren, Ilan, Levitsky, Gershon, Colman, Lewis
• Granted Patent: US 7,260,976 B2
• Time in Patent Office: Days
• US Class Current: 600/529
• CPC Class Codes: A61B 5/083 Measuring rate of metabolism by using breath test, e.g. measuring rate of oxygen consumption

Abstract

A calibration checking device, and methods of mandating its use at regular time intervals, to ensure maintenance of the accuracy of gas analyzers, especially for use with breath tests. Each calibration checking device is designed to be used for a predetermined number of tests. After first connection of a new calibration checking device, a volume of known calibration checking gas is released into the instrument, and a calibration checking measurement is initiated. A signal is sent to a counting mechanism which both enables the use of the instrument, and commences a count of the number of tests performed by the breath tester. When the number of tests is exceeded, the instrument is disenabled. The device can include a moisture filter having an interface with the instrument, which prevents its operation if the filter is used beyond the recommended number of times, or if excess moisture renders it saturated.

Claims

1. 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.

2. A breath simulator device according to claim 1 and wherein said simulation of exhaled breaths of a subject, comprises at least one of the properties selected from the group consisting of flow rate, total gas species concentration, isotopic ratio of said gas species sample, and respiration rate.

3. A calibration checking device comprising a porous tube which allows preferential diffusion through its wall of one component of a calibrating gas.

4. A calibration checking device according to claim 3 and wherein said porous tube is operative to amend the isotopic ratio of a calibrating gas during passage through it.

5. A calibration checking device according to claim 4 and also comprising gas switching means for alternating the output of said device between calibration gas with and without an amended isotopic ratio.

6. A calibration checking device according to claim 5 and wherein said gas switching means is also operative for alternating the output of said device between calibration gas with an amended isotopic ratio, calibration gas without an amended isotopic ratio, and air without any calibrating gas.

7. A system checking device according to claim 6 and wherein said gas switching means operates at a switching rate in a range similar to human respiration rate.

8. A calibration checking device comprising:

a calibrating gas inlet conduit supplying calibrating gas to a porous tube, said porous tube allowing preferential diffusion through its wall of one component of said calibrating gas;

a calibrating gas outlet conduit, conveying calibrating gas with an amended composition from said porous tube; and

an outer chamber through which said porous tube passes, said outer chamber being continually flushed with a purging gas to remove any component of said calibrating gas which diffuses through said wall of said porous tube.

9. A calibration checking device according to claim 8 operative to amend the isotopic ratio of a calibrating gas during passage through it.

10. A calibration checking device according to claim 9 and also comprising gas switching means for alternating the output of said device between calibration gas with and without an amended isotopic ratio.

11. A calibration checking device according to claim 10 and wherein said gas switching means is also operative for alternating the output of said device between calibration gas with an amended isotopic ratio, calibration gas without an amended isotopic ratio, and air without any calibrating gas.

12. A calibration checking device according to claim 11 and wherein said gas switching means operates at a switching rate in a range similar to a human respiration rate.

13. A breath tester incorporating a calibration checking device according to claim 12, and also comprising a receiver into which is inserted a container of calibrating gas, said receiver including means for enabling a calibration checking procedure in said breath tester.

14. A breath tester according to claim 13, and wherein said container of calibrating gas is made of glass, and insertion of said container into said receiver actuates breakage of said glass, thereby releasing said calibrating gas.

15. A breath tester according to claim 13, and wherein said container of calibrating gas is closed by means of a pressure seated check valve, and insertion of said container into said receiver depresses said check valve, thereby releasing said calibrating gas.

16. A breath tester according to claim 13, and wherein said container of calibrating gas is closed by means of a thin metallic foil, and insertion of said container into said receiver enables a needle to penetrate said thin foil, thereby releasing said calibrating gas.

17. A breath tester according to claim 13, and wherein said container of calibrating gas is a hermetically sealed flexible plastic bag

18. A breath tester incorporating a calibration checking procedure, operative to ensure that said breath tester is enabled only if a routine mandatory calibration check is performed after a predetermined number of breath tests.

19. A breath tester according to claim 18, and also operative to ensure that said breath tester is enabled only if an authorized and new container of calibration gas is used for said routine mandatory calibration check.

20. A method of calibrating a breath tester comprising the steps of:

performing a calibration check on said breath tester by the use of at least two gases having known isotopic ratio differences between them;

comparing the deviation in the differences in the isotopic ratios measured by said breath tester from those of said at least two gases; and

performing a calibration of said breath tester if said deviation exceeds a predetermined value.

21-24. -24. (canceled)

26-37. -37. (canceled)

39-47. -47. (canceled)

49. A calibration checking device for use with a gas analyzer, comprising:

a sampling line for conveying a gas to be analyzed to said gas analyzer;

at least one enclosure housing at least one container of calibration gas;

at least one mechanism for releasing said calibration gas in said at least one container into said enclosure, said mechanism having interactive control contact with said gas analyzer; and

at least one delivery conduit connecting between said enclosure and said sampling tube for conveying said calibration gas after release into said sampling line.

50. A calibration checking device for use with a gas analyzer according to claim 49 and wherein said interactive control contact comprises the actuation of said mechanism by means of said gas analyzer

51. A calibration checking device for use with a gas analyzer according to claim 49 and wherein said interactive control contact comprises the transmission of a signal to said gas analyzer on actuation of said mechanism.

52. A calibration checking device for use with a gas analyzer according to claim 49, and wherein said at least one container of calibration gas comprises two containers of calibration gas.

53. A calibration checking device for use with a gas analyzer according to claim 49, and wherein said at least one delivery conduit comprises two delivery conduits.

54. A calibration checking unit for use with a gas analyzer, comprising:

a calibration gas mixture comprising at least a first and a second gas; and

a delivery conduit for conveying said calibration gas mixture to said gas analyzer, said delivery conduit comprising a material which allows preferential diffusion through its wall of at least one of said at least a first and a second gas.

55. A calibration checking unit for use with a gas analyzer according to claim 54, and wherein said material is a selective membrane.

56. A calibration checking unit for use with a gas analyzer according to claim 54, and wherein said material is a porous diffusive tube.

57. A kit for calibration 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.

58. A kit for calibration checking a gas analyzer according to claim 57, and wherein at least one of said sampling tubes comprises a fluid filter.

59. A kit for calibration checking a gas analyzer comprising:

at least one calibration checking unit capable of interactive communication with said gas analyzer; and

a plurality of disposable sampling tubes for each of said at least one calibration checking unit.

60. A kit for calibration checking a gas analyzer according to claim 59, and wherein at least one of said sampling tubes comprises a fluid filter.

61. A calibration checking unit operative to generate a second calibration material from a first material input thereto.

62. A calibration checking unit according to claim 61 and wherein said first material is also a calibrating material.

63. A calibration checking unit according to claim 61 and wherein said materials are gases for use in a gas analyzer.

64. A breath bringer which changes a characteristic during use.

65. A breath bringer according to claim 64, and wherein said characteristic is a color.

66. (canceled)