In-vivo measurement of end-tidal carbon monoxide concentration apparatus and methods

• US 5,293,875 A
• Filed: 06/16/1992
• Issued: 03/15/1994
• Est. Priority Date: 06/16/1992
• Status: Expired due to Fees

• Current Assignee: Natus Medical Incorporated
• Original Assignee: Natus Medical Incorporated
• Inventors: Stone, Robert T.
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): Nasser, Robert L.
• Application Number:
  US07/899,261
• Time in Patent Office: 637 Days
• Field of Search: 128/716, 128/719, 128/204.22, 128/204.23, 128/205.22
• US Class Current: 600/532
• CPC Class Codes: A61B 5/0836 Measuring rate of CO2 production
• CPC Class Codes: G01N 33/497 of gaseous biological material, e.g. breath

Abstract

A noninvasive device and methods for measuring the end-tidal carbon monoxide concentration in a patient'"'"'s breath, particularly newborn and premature infants. The patient'"'"'s breath is monitored. An average carbon monoxide concentration is determined based on an average of discrete samples in a given time period. The ratio of the end-tidal portion of the breath flow sample is separately determined, preferably based on monitoring the level of carbon dioxide in the gas sample and identifying the carbon dioxide concentration levels corresponding to the end-tidal portion of the breath sample. The sensed carbon monoxide level is converted to the end-tidal carbon monoxide level by subtracting the ambient carbon monoxide level and dividing the remainder by the ratio of end-tidal breath to breath in the breath sample. An easy to use microcontroller-based device containing a carbon dioxide detector, a carbon monoxide detect and a pump for use in a hospital, home, physician'"'"'s office or clinic by persons not requiring high skill and training is described.

Claims

1. Apparatus for monitoring a patient'"'"'s end-tidal gas flow during breathing comprising:

a first gas detector for monitoring the concentration of a first selected gas in a gas sample and having an output corresponding to the monitored first selected gas concentration;

a first means for monitoring a parameter corresponding to the patient'"'"'s breathing and determining the ratio of said parameter corresponding to the patient'"'"'s end-tidal breath portion to said parameter corresponding to inspired air as a duty cycle and having an output corresponding to the determined duty cycle;

first means for providing a sample of room air to the first gas detector for measuring a background concentration of the first gas;

second means for providing a sample of the patient'"'"'s breath to the first gas detector for measuring a breath sample concentration of the first gas in the patient'"'"'s breath; and

first means for receiving the output of the first gas detector and the first monitoring means for determining a end-tidal concentration of the first gas in response to the determined duty cycle, the determined background concentration of the first gas in room air, and the determined breath sample concentration of the first gas in the patient'"'"'s breath.

2. The apparatus of claim 1 wherein the first gas is carbon monoxide, the first gas detector detects the concentration of carbon monoxide and the first receiving and determining means determines the end-tidal concentration of carbon monoxide.

3. The apparatus of claim 1 wherein the first monitoring and determining means further comprises:

a second gas detector for monitoring an concentration of a second selected gas in the patient'"'"'s breath other than the first selected gas and having an output corresponding to the second selected gas concentration; and

second means for receiving the output of the second gas detector and for determining the duty cycle as the ratio of the end-tidal portion of the second gas in the patient'"'"'s breath to the patient'"'"'s breath based on monitored relative changes in the sensed concentration of the second gas.

5. The apparatus of claim 3 wherein the second providing means further comprises means for passing the sample of the patient'"'"'s breath to the first and second gas detectors wherein the second gas detector monitors changes in the concentration of the second gas in the patient'"'"'s breath over time.

6. The apparatus of claim 5 wherein the passing means further comprises a pump and a flow path, the flow path connecting the first and second gas detectors in gaseous communication and the pump passing a gas sample therethrough.

7. The apparatus of claim 6 wherein the second providing means turns the pump on for a selected first time period.

8. The apparatus of claim 6 wherein the first providing means turns the pump on for a first selected time period and the first gas detector detects the room air concentration of the first gas.

9. The apparatus of claim 8 wherein the second providing means turns the pump on for a second selected time period following the end of a first time period.

10. The apparatus of claim 8 wherein the first providing means turns the pump on for on the order of forty-five seconds and wherein the second providing means turns the pump on for on the order of forty-five seconds.

11. The apparatus of claim 7 wherein the second receiving and determining means further comprises:

first means for periodically sampling the output of the second gas detector corresponding to the sensed concentration of the second gas during the first selected time period; and

comparator means for comparing the sampled signals to a selected threshold;

wherein the second receiving and determining means determines the duty cycle based on the sampled signals that are above and below the selected threshold.

12. The apparatus of claim 11 wherein the second receiving and determining means determines the duty cycle based on the number of sampled signals above the selected threshold.

13. The apparatus of claim 12 wherein the second receiving and determining means determines the duty cycle based on the ratio of the number of samples above the threshold and the number of samples.

14. The apparatus of claim 11 further comprising

second means for periodically sampling the output of the first gas detector corresponding to the sensed concentration of the first gas during the first selected time period;

and

means for providing a first signal corresponding to an average of a selected number of sampled second signals near the end of the first period.

15. The apparatus of claim 14 wherein the first time period is on the order of 45 seconds, the first sampling means samples the second gas detector output on the order of 30 Hz, the second sampling means samples the first gas detector output on the order of 1.0 Hz, and the selected number of sampled second signals is on the order of 5.

16. The apparatus of claim 14 wherein the first gas detector is a carbon monoxide gas analyzer and the second gas detector is a carbon dioxide gas analyzer.

17. The apparatus of claim 11 wherein the first gas detector is a carbon monoxide gas analyzer and the second gas detector is a carbon dioxide gas analyzer.

18. The apparatus of claim 5 wherein the first gas detector is a carbon monoxide gas analyzer and the second gas detector is a carbon dioxide gas analyzer.

19. The apparatus of claim 2 wherein the first gas detector detects the room air carbon monoxide concentration in response to the first providing means and an average concentration of carbon monoxide in the patient'"'"'s breath in response to the second providing means.

20. The apparatus of claim 19 wherein the first receiving and determining means determines the end-tidal carbon monoxide concentration based on the room air concentration, the average concentration, and the duty cycle.

21. The apparatus of claim 1 further comprising an interactive keyboard and display associated with the first and second providing means.

22. The apparatus of claim 1 wherein the second providing means provides a sample of the patient'"'"'s breath for a first time period so that the first gas detector provides a signal corresponding to an average concentration of the first gas.

23. The apparatus of claim 1 wherein the first means for monitoring breathing further comprises an impedance sensor for coupling the patient for sensing changes in impedance with the patient'"'"'s respiratory activity.

24. The apparatus of claim 1 wherein the first means for monitoring breathing further comprises a spirometer.

4. The apparatus of clam 3 wherein the second gas detector further comprises a carbon dioxide gas analyzer.

25. A method of measuring end-tidal carbon monoxide concentration in expired breath comprising the steps of:

(a) measuring a carbon monoxide concentration in ambient room air (CO_room);

(b) sampling a patient'"'"'s breath over a first period of time;

(c) measuring the carbon monoxide concentration (CO) in a sampled patient'"'"'s breath during the first time period;

(d) determining a duty cycle of an end-tidal portion of the patient'"'"'s breath during the first time period; and

(e) determining an end-tidal carbon monoxide level based on the determined duty cycle, the measured CO_room, and the measured CO.

26. The method of claim 25 wherein the step (e) further comprises subtracting the measured CO_room from the measured CO and dividing the difference by the determined duty cycle.

27. The method of claim 25 wherein step (a) further comprises passing a stream of room air through a carbon monoxide detector during a second time period and measuring the CO_room corresponding to the room carbon monoxide concentration.

28. The method of claim 27 wherein step (a) further comprises measuring an average of the CO concentration in ambient room air over a second period of time.

29. The method of claim 28 further comprising measuring the CO as an average of a first number of discrete average samples obtained at the end of the first time period.

30. The method of claim 25 wherein step (d) further comprises determining the duty cycle based on the sampled breath during the first time period.

31. The method of claim 30 wherein step (d) further comprises:

(i) detecting the end-tidal portion of a second gas in the sampled breath other than the first gas; and

(ii) determining the duty cycle as the ratio of the end-tidal portion to the sampled breath portion of the second gas during the first time period.

32. The method of claim 31 wherein the second gas is carbon dioxide.

33. The method of claim 32 wherein step (e) further comprises subtracting the measured CO_room from the measured CO and dividing the difference by the determined duty cycle.

34. The method of claim 33 wherein step (a) further comprises passing a stream of room air through a carbon monoxide detector during a second time period and measuring the CO_room corresponding to the room carbon monoxide level.

35. The method of claim 34 wherein step (c) further comprises measuring the CO as an average of a first number of discrete average samples obtained at the end of the first time period.

36. The method of claim 32 wherein step (a) further comprises measuring an average carbon monoxide concentration in ambient room air over a second period of time.

37. The method of claim 32 wherein step (d)(ii) further comprises periodically sampling the sensed concentration of carbon dioxide at a first rate during the first time period, wherein step (c) further comprises periodically sampling the sensed concentration of carbon monoxide at a second rate during the first time period.

38. The method of claim 37 wherein the first rate is on the order of 30 Hz and the second rate is on the order of 1.0 Hz.

39. The method of claim 37 wherein the number of average samples is on the order of 5.

40. The method of claim 37 wherein step (c) further comprises low pass filtering the samples of carbon monoxide sensed during the first time period.

41. The method of claim 25 further comprising controlling a device having a first gas analyzer for performing step (a) prior to performing step (b), and providing a first delay period between the performance of steps (a) and (b).

42. The method of claim 41 further comprising providing a second delay period following step (b) each time it is performed and before step (a) is next performed.

43. The method of claim 42 wherein the second delay is on the order of from 1 to 3 minutes.

44. The method of claim 42 wherein the first delay period is on the order of from 1 to 3 minutes.

45. Apparatus for determining the carbon monoxide concentration in the end tidal portion of the exhaled breath flow of a patient, comprising:

a carbon monoxide gas analyzer having a gas input for receiving a gas sample and a signal output CO representative of the measured concentration of carbon monoxide in the gas sample, said carbon monoxide gas analyzer having a response time that is not sufficiently fast to distinguish the carbon monoxide concentration of the end tidal portion from other portions of a gas sample that is a patient breath flow;

a carbon dioxide gas analyzer having an input for receiving a gas sample and a signal output CO2 representative of the measured concentration of carbon dioxide in the gas sample, said carbon dioxide gas analyzer having a response time that is sufficiently fast to distinguish the carbon dioxide concentration of the end tidal portion form other portions of a gas sample that is a patient breath flow;

means for analyzing the signal output CO2 over a given time period and determining a duty cycle for said signal output relative to a preselected signal parameter;

first means for providing a room air gas sample flow to the carbon monoxide gas analyzer for a first duration so that the carbon monoxide gas analyzer signal output CO corresponds to a background carbon monoxide concentration;

second means for providing a patient breath flow gas sample flow of a second duration to the carbon monoxide gas analyzer and to the carbon dioxide gas analyzer, wherein the carbon monoxide gas analyzer signal output CO corresponds to an average carbon monoxide concentration near the end of the second duration, the preselected signal parameter corresponds to the patient'"'"'s end tidal carbon dioxide concentration, and the analyzing means determines the duty cycle of the end tidal portion of the breath flow sample; and

calculating means for receiving the background carbon monoxide concentration, the average carbon monoxide concentration and the determined duty cycle and calculating therefrom the end tidal carbon monoxide concentration.

46. The apparatus of claim 45 wherein the analyzing means further comprises a first means for comparing the signal output CO2 to a first threshold and determining the duty cycle of the relative portion of said signal CO2 above the threshold for the given time period.

47. The apparatus of claim 45 wherein the first and second providing means further comprise:

a flow path connecting the gas inputs of the carbon monoxide and carbon dioxide gas analyzers, the flow path having a gas inlet for receiving a gas sample;

a pump connected to the flow path;

a switch for operating the pump to cause the gas sample at the gas inlet to flow along the flow path to the carbon monoxide and carbon dioxide gas analyzers.

48. The apparatus of claim 47 further comprising a flow regulator interposed in the flow path for regulating the flow of the gas sample.

49. The apparatus of claim 47 wherein the first and second providing means further comprise:

a display means for displaying information;

a first means for indicating on the display means that the flow path inlet is to be placed to sample room air and first means for actuating the switch to pass a sample of room air to the carbon monoxide gas analyzer for a first time period; and

a second means for indicating that the flow path inlet is to be placed to sample patient breath and second means for actuating the switch to pass a sample of patient breath to the carbon monoxide and carbon dioxide gas analyzers for a second time period, wherein the calculating means calculates the end tidal carbon monoxide concentration following the end of the second time period.

50. The apparatus of claim 45 wherein the calculating means calculates the end tidal carbon monoxide concentration as equal to the quantity of the average carbon monoxide concentration minus the background carbon monoxide concentration divided by the duty cycle, wherein the duty cycle corresponds to the end tidal portion of the patient breath flow gas sample.