Cardio-respiratory control and monitoring system for determining CPAP pressure for apnea treatment

• US 5,353,788 A
• Filed: 09/21/1992
• Issued: 10/11/1994
• Est. Priority Date: 09/21/1992
• Status: Expired due to Term

• Current Assignee: Respironics Incorporated
• Original Assignee: Respironics Incorporated
• Inventors: Miles, Laughton E.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US07/948,170
• Time in Patent Office: 750 Days
• Field of Search: 128/205.24, 128/204.18, 128/204.21, 128/204.23, 128/719, 128/204.26, 128/200.24
• US Class Current: 128/204.23
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/08 Other bio-electrical signals
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/18 Rapid eye-movements [REM]
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)

Abstract

A system and method for controlling and monitoring externally administered breathing air pressure in a series of cycles. During each cycle, the breathing air pressure starts at a base value and is slowly and progressively increased then rapidly reduced to the base value. If the control and monitoring system detects changes consistent with the presence of upper airway obstruction, the values of breathing air pressure for the next cycle are changed to a higher pressure range. A plurality of vital signs may be monitored and included in the breathing air pressure control system. Information obtained during this procedure is subsequently used to determine the most appropriate externally administered breathing airflow pressure for that person.

Claims

1. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person comprising

monitoring means for gathering one or more types of physiological information from said person;

means for sensing the pressure of the breathing air being supplied to said person;

recording means for recording said physiological information and said breathing air pressure;

base value control means determining a base value for said breathing air pressure based upon said physiological information;

air supply means for supplying breathing air at determined pressure levels relative to said base value;

air pressure control means for maintaining said air pressure at one of said pressure levels for a predetermined first time interval, increasing said air pressure at a first predetermined rate during a predetermined second time interval to another one of said pressure levels, repeating said process of maintaining and increasing air pressure for a predetermined number of times, and reducing said air pressure at a predetermined second rate during a predetermined third time interval to said base pressure level,

said first, second and third time intervals constituting a control cycle of a predetermined fourth time interval; and

means for repeating said control cycle;

wherein said third time interval is at least five times smaller than the sum of said first time intervals plus the sum of said second time intervals.

2. A cardio-respiratory apparatus as claimed in claim 1 wherein said air pressure control means increases said breathing air pressure stepwise during said second time periods for a predetermined number of steps maintaining said breathing air pressure between successive steps for a predetermined fifth time period, and

returns said breathing air pressure at the end of a control cycle during said third time interval stepwise to said base value, maintaining said breathing air pressure between successive steps for a predetermined sixth time period.

3. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 1 wherein said monitoring means include

sensors for collecting physiological signals, physiological data processing means for extracting said types of physiological information from said physiological signals and providing physiological data indicative of an abnormal increase in the airflow resistance in the upper airway of said person using at least one of said physiological signals.

4. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 2, wherein said monitoring means includes means for setting high and low limit values for each of said types of physiological information used in determining said breathing air pressure base value, at least one of said physiological information when passing said limit values being indicative of an abnormal increase in airflow resistance in the upper airway of said person, and wherein said base value control means increases said base value for a control cycle by a first predetermined value if one or more of said at least one physiological information passes an associated one of said limit values during a preceding one of said control cycles.

5. A cardio-respiratory system for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 4, wherein said sensors for collecting physiological signals include sensors for providing a blood oxygen saturation level signal.

6. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 4, wherein said sensors for collecting physiological signals include sensors for providing a blood oxygen saturation level signal;

and wherein

said base value control means include means for increasing said base value if said blood oxygen saturation level fell below a predetermined value during a predetermined number of said preceding control cycles.

7. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 3,

wherein said monitoring means includes means for setting high and low limit values for each of said types of physiological information used in determining said breathing air pressure base value,

at least one of said physiological information when passing said limit values being indicative for an abnormal increase in airflow resistance in the upper airway of said person, and

wherein said base value for a control cycle is increased by a first predetermined value if one or more of said at least one physiological information passes an associated one of said limit values during a predetermined number of said control cycles, and

wherein said air supply means decreases said base value for a control cycle by a second predetermined value if one or more of said at least one physiological information did not pass any associated one of said limit values during said predetermined number of said control cycles.

8. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 3,

wherein said monitoring means includes means for setting high and low limit values for each of said types of physiological information used in determining said breathing air pressure base value,

at least one of said physiological information when passing said limit values being indicative of an abnormal increase in the airflow resistance in the upper airways of said person, and wherein said base value control means decreases said base value for a control cycle by a first predetermined value if one or more of said at least one physiological information did not pass any associated one of said limit values during a predetermined number of said control cycles.

9. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 8 wherein said sensors for collecting physiological signals include sensors for providing a blood oxygen saturation level signal;

and wherein

said base value control means include means for decreasing said base value if said blood oxygen saturation level did not fall below a predetermined value during a predetermined number of said preceding control cycles.

10. A cardio-respiratory system for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 3 wherein said sensors for collecting physiological signals include sensors for providing a blood oxygen saturation level signal.

11. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 10,

wherein said air supply means include base value control means for increasing and decreasing said base value of said air pressure, and wherein said base value control means increases said base value for a control cycle if said blood oxygen saturation level fell below a predetermined value during a preceding one of said control cycles, and wherein said base value control means decreases said base value for said control cycle if said blood oxygen saturation level remained above said predetermined level during a predetermined number of said control cycles.

12. A cardio-respiratory apparatus for monitoring physiological signs and controlling breathing air pressure of a person as claimed in claim 8 wherein said sensors for collecting physiological signals include sensors for providing a blood oxygen saturation level signal;

and wherein

said base value control means include

means for decreasing said base value if said blood oxygen saturation level did not fall below a predetermined value during a predetermined number of said preceding control cycles, and

means for increasing said base value if said blood oxygen saturation level fell below a predetermined value during a predetermined number of said preceding control cycles.

13. A cardio-respiratory monitoring and control method for monitoring physiological signs and controlling breathing air pressure of a person during repetitive control cycles, each said control cycle comprising the steps of

monitoring and recording said physiological signs and said breathing air pressure of said person;

determining a base value for said breathing air pressure based upon said physiological information;

cyclicly supplying breathing air at determined pressure levels relative to said base value, including the steps of;

(a) maintaining said air pressure at one of said pressure levels for a predetermined first time interval, and

(b) increasing said air pressure at a predetermined first rate during a predetermined second time interval to another one of said pressure levels, and repeating step (b) a predetermined number of times before reducing said air pressure at a predetermined second rate during a predetermined third time interval to the base pressure value pressure,

thereby completing a control cycle of a duration equal to a predetermined fourth time interval; and

repeating said control cycle;

wherein in each said control cycle the sum of each said first time interval plus the sum of each said second time intervals is at least five times longer than said third time interval.

14. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said breathing air pressure is cyclicly increased from said base value stepwise in intervals of 5 minutes and returned to said base value at the end of 30 minutes, with all changes in pressure occur at the rate of 0.50 cm H₂ O each 10 seconds.

15. A cardio-respiratory monitoring and control method as claimed in claim 13, wherein the increases in air pressure between successive ones of said air pressure levels at said first rate are carried out in substeps each having a predetermined fifth time interval.

16. A cardio-respiratory monitoring and control method as claimed in claim 13, wherein the decrease in air pressure to said base level pressure at said second rate is carried out in substeps each having a predetermined sixth time interval.

17. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said fourth time interval is about 30 minutes, and includes 6 of said first time intervals in which said breathing air pressure is held at 6 different air pressure levels.

18. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said first rate is 0.5 H₂ O per 10 seconds.

19. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said base pressure value is 4 cm.

20. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said base value of said breathing air pressure is maintained for a full control cycle time.

21. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said breathing air pressure is decreased to said base value and maintained said base value for a full control cycle time.

22. A cardio-respiratory monitoring and control method as claimed in claim 13 wherein said breathing air pressure is cyclicly increased from said base value stepwise in intervals of 5 minutes in two sub-steps in intervals of 10 seconds, and returned to said base value at the end of 30 minutes.

23. A cardio-respiratory monitoring and control method as claimed in claim 13, said method further including processing the data obtained from said monitoring of physiological information,

said processing including determining physiological induced changes in said breathing air pressure, and

providing a measure of an abnormal increase in the airflow resistance in the upper airway of said person based on said physiological induced changes.

24. A cardio-respiratory monitoring and control method as claimed in claim 23, said monitoring of physiological information includes the measurement of blood oxygen saturation.

25. A cardio-respiratory monitoring and control method as claimed in claim 23, wherein said method further includes setting high and low limit values for each type of said physiological information and said physiological induced changes in said breathing air pressure, said limit values being indicative of an abnormal increase in the airflow resistance of the upper airway;

said method further includes

repetitive execution of said control cycle, and increasing said base pressure value for a following control cycle by a predetermined value if one or more of said physiological information or physiologically induced changes in said breathing air pressure passes an associated one of said limit values during one of said preceding control cycles.

26. A cardio-respiratory monitoring and control method as claimed in claim 25, said monitoring of physiological information includes the measurement of blood oxygen saturation.

27. A cardio-respiratory monitoring and control method as claimed in claim 23, said method further including processing the data obtained from said monitoring of physiological information,

said processing further including

determining patterns in said physiological information and said physiological induced changes of said breathing air pressure for providing indications of abnormal increase in the airflow resistance in the upper airway of said person based on said physiological induced changes.

28. A cardio-respiratory monitoring and control method as claimed in claim 27, wherein said method further includes setting high and low limit values for said patterns determined in said physiological information and said physiological induced changes in said breathing air pressure, said limit values being indicative of an abnormal increase in the airflow resistance of the upper airway;

said method further includes

repetitive execution of said control cycle, and increasing said base pressure value for a following control cycle by a predetermined value if one or more of said physiological information or physiologically induced changes in said breathing air pressure passes an associated one of said limit values during one of said preceding control cycles.

29. A cardio-respiratory monitoring and control method as claimed in claim 28, said monitoring of physiological information includes the measurement of blood oxygen saturation.

30. A cardio-respiratory monitoring and control method as claimed in claim 23, wherein said method further includes setting high and low limit values for each type of said physiological information and said physiological induced changes in said breathing air pressure, said limit values being indicative of an abnormal increase in the airflow resistance of the upper airway;

said method further includes

repetitive execution of said control cycle, and decreasing said base pressure value for a following control cycle by a predetermined value if none of said physiological information or physiologically induced changes in said breathing air pressure passed an associated one of said limit values during one of said preceding control cycles.

31. A cardio-respiratory monitoring and control method as claimed in claim 30, said monitoring of physiological information includes the measurement of blood oxygen saturation.

32. A cardio-respiratory monitoring and control method as claimed in claim 23, said method further including processing the data obtained from said monitoring of physiological information,

said processing further including

determining patterns in said physiological information and said physiological induced changes of said breathing air pressure for providing indications of abnormal increase in the airflow resistance in the upper airway of said person based on said physiological induced changes.

33. A cardio-respiratory monitoring and control method as claimed in claim 32, wherein said method further includes setting high and low limit values for said patterns determined in said physiological information and said physiological induced changes in said breathing air pressure, said limit values being indicative of an abnormal increase in the airflow resistance of the upper airway;

said method further includes

repetitive execution of said control cycle, and increasing said base pressure value for a following control cycle by a predetermined value if one or more of said physiological information or physiologically induced changes in said breathing air pressure passes an associated one of said limit values during one of said preceding control cycles, and

decreasing said base pressure value for a following control cycle by a predetermined value if none of said physiological information or physiologically induced changes in said breathing air pressure passed an associated one of said limit values during one of said preceding control cycles.

34. A cardio-respiratory monitoring and control method as claimed in claim 33, said monitoring of physiological information includes the measurement of blood oxygen saturation.

35. A cardio-respiratory monitoring and control method as claimed in claim 23, wherein said method further includes setting high and low limit values for each type of said physiological information and said physiological induced changes in said breathing air pressure, said limit values being indicative of an abnormal increase in the airflow resistance of the upper airway;

said method further includes

repetitive execution of said control cycle, and increasing said base pressure value for a following control cycle by a predetermined value if one or more of said physiological information or physiologically induced changes in said breathing air pressure passes an associated one of said limit values during one of said preceding control cycles, and

decreasing of said base pressure value for a following control cycle by a predetermined value if none of said physiological information or physiologically induced changes in said breathing air pressure passed an associated one of said limit values during one of said preceding control cycles.

36. A cardio-respiratory monitoring and control method as claimed in claim 35, said monitoring of physiological information includes the measurement of blood oxygen saturation.