Apparatus for diagnostic gas analysis

• US 8,597,580 B2
• Filed: 11/16/2010
• Issued: 12/03/2013
• Est. Priority Date: 09/16/2002
• Status: Active Grant

• Current Assignee: Circassia AB
• Original Assignee: Aerocrine AB (Circassia Group Plc)
• Inventors: von Bahr, Pontus, Hemmingsson, Tryggve, Jakobsson, Anders, Gustafsson, Fredric
• Primary Examiner(s): Alexander, Lyle
• Application Number:
  US12/947,096
• Publication Number:
  US 20110066060A1
• Time in Patent Office: 1,113 Days
• Field of Search: 436/116, 436/177, 422/83, 422/84, 422/93, 600/532
• US Class Current: 422/84
• CPC Class Codes: A61B 5/0803 Recording apparatus specially adapted therefor
• CPC Class Codes: A61B 5/082 Evaluation by breath analysis, e.g. determination of the chemical composition of exhaled breath A61B5/083, A61B5/091 take precedence
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: G01N 1/22 in the gaseous state specially adapted for biological material G01N33/497; measuring breath flow A61B5/087
• CPC Class Codes: G01N 21/766 of gases
• CPC Class Codes: G01N 27/28 Electrolytic cell components
• CPC Class Codes: G01N 33/0016 by regulating a physical variable, e.g. pressure or temperature
• CPC Class Codes: G01N 33/0037 NOx
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath
• CPC Class Codes: Y02A 50/20 Air quality improvement or preservation, e.g. vehicle emission control or emission reduction by using catalytic converters
• CPC Class Codes: Y10T 436/177692 Oxides of nitrogen
• CPC Class Codes: Y10T 436/179228 Both nitrogen oxide and dioxide
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

A handheld, small but accurate and reliable device for diagnostic NO measurements using a NO sensor, where the parameters governing the taking of the sample are different from the parameters optimal for the accuracy of said NO sensor I described. By temporarily storing a portion of the exhaled air, and feeding this to the sensor at a flow rate adapted to the NO sensor, the accuracy and sensitivity of a system/method involving NO sensors, in particular electrochemical NO sensors, can be increased. The method for diagnostic NO measurements comprises steps for controlling the inhalation of NO free air, as well as the exhalation, both by built-in means and by audible and/or visual feedback to the patient.

Claims

1. A device for diagnostic measurement of NO in exhaled breath, comprising:

an NO scrubber;

an inlet/outlet through which a patient inhales air via the NO scrubber and exhales at a first flow rate and pressure dependent on the patient'"'"'s control over the patient'"'"'s exhalation;

an NO sensor that analyzes a sample of the exhaled breath during an analysis period to detect a level of NO in the sample of the exhaled breath;

a buffer chamber defining a volume and that temporarily stores the sample of the exhaled breath before analysis by the NO sensor;

a flow controller disposed between the buffer chamber and the NO sensor that allows passage of the sample of exhaled breath to the NO sensor during the analysis period; and

a sample feeder in the form of a sample pump or a fan that actively feeds the sample of exhaled breath from the buffer chamber to the NO sensor at a predetermined and constant second flow rate over the analysis period, wherein the second flow rate is smaller than the first flow rate.

2. The device according to claim 1, wherein the device further comprises a variable flow regulator disposed between the inlet and the buffer chamber for controlling the flow of the exhaled breath into the buffer chamber.

3. The device according to claim 2, wherein the flow regulator has the function of controlling the exhalation flow to 20-800 ml/s.

4. The device according to claim 2, wherein the flow regulator has the function of controlling the exhalation flow to 45-55 ml/s.

5. The device according to claim 1, wherein the sample feeder supplies the sensor with a steady flow of about 0.5 ml/s to about 15 ml/s.

6. The device according to claim 1, wherein the sample feeder supplies the sensor with a steady flow of about 2 ml/s to about 10 ml/s.

7. The device according to claim 1, wherein the sample feeder supplies the sensor with a steady flow of about 0.5 ml/s to about 15 ml/s during a time period longer than the duration of the exhalation.

8. The device according to claim 1, wherein the sample feeder supplies the sensor with a steady flow of about 2 ml/s to about 10 ml/s during a time period longer than the duration of the exhalation.

9. The device according to claim 1, further comprises a humidity equalizer disposed between the buffer chamber and the NO sensor for equalizing the humidity of the sample to ambient humidity conditions.

10. The device according to claim 9, wherein humidity equalizer is a length of tube made from a catalytic membrane material.

11. The device according to claim 1, further comprising an exhaled breath controller.

12. The device according to claim 11, wherein the exhaled breath controller includes a pressure sensor.

13. The device according to claim 11, wherein the exhaled breath controller includes a pressure sensor and a feedback assembly that outputs feedback to a patient that uses the device according to measurements taken by the pressure sensor.

14. The device according to claim 11, wherein the exhaled breath controller includes a flow sensor.

15. The device according to claim 11, wherein the exhaled breath controller includes a flow sensor and a flow controller for controlling the flow based on measurements of the flow sensor.

16. The device according to claim 11, wherein the exhaled breath controller includes a flow sensor and a feedback assembly that outputs feedback to a patient that uses the device according to measurements taken by the flow sensor.

17. The device according to claim 1, wherein the buffer chamber terminates in another valve which is open to the environment during at least an initial phase of the exhalation and closes when the sample of exhaled breath is fed to the NO sensor during the analysis period.

18. The device according to claim 1, further comprising an interface for receiving a memory assembly on which data linked to a specific user is stored and the device is configured to record NO measurement data on the memory assembly.

19. The device according to claim 18, wherein the device is configured to adapt operation to at least one of different users or different user groups based on the data stored on the memory assembly.

20. The device according to claim 12, wherein the pressure sensor is configured to monitor the pressure of exhaled breath to ensure that the soft palate of the patient is closed during exhalation and, if not, the device giving feedback to the user to adjust the exhalation.

21. The device according to claim 1, wherein the volume of the buffer chamber is sufficient to store the sample of exhaled breath that is feed to the NO sensor over the analysis period, the analysis period being longer than a duration of the exhalation.

22. The device according to claim 21, the buffer chamber expands to the volume from a smaller volume.

23. The device according to claim 1, further comprising a temperature equalizer configured to actively equalize a temperature of the feed sample of exhaled breath to a temperature of the NO sensor.

24. The device according to claim 23, wherein the temperature equalizer surrounds the NO sensor and makes contact with the sample of exhaled breath as the sample of exhaled breath is fed to the NO sensor.

25. The device according to claim 23, wherein the temperature equalizer maintains the NO sensor and the feed sample of exhaled breath at a predetermined temperature during the analysis period.

26. The device according to claim 1, wherein the NO sensor is an electrochemical NO sensor.

27. The device according to claim 1, wherein the flow controller is a valve disposed between the buffer chamber and the NO sensor that allows has a closed position to separate the buffer chamber from the electrochemical NO sensor and an open position to allow passage of the sample of exhaled breath to the electrochemical NO sensor during the analysis.