Method and apparatus for maintaining airway patency to treat sleep apnea and other disorders

• US 5,148,802 A
• Filed: 09/22/1989
• Issued: 09/22/1992
• Est. Priority Date: 09/22/1989
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Sanders, Mark H., Zdrojkowski, Ronald J.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): Lewis, Aaron J.
• Application Number:
  US07/411,012
• Time in Patent Office: 1,096 Days
• Field of Search: 128/204.21, 128/204.23, 128/204.26, 128/848, 128/205.25, 128/207.18, 128/204.18
• US Class Current: 128/204.18
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• CPC Class Codes: A61M 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/026 specially adapted for predicting, e.g. for determining an information representative of a flow limitation during a ventilation cycle by using a root square technique or a regression analysis
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital

Abstract

An improved methodology and apparatus for the treatment of sleep apnea through application of alternating high and low level positive airway pressure within the airway of the patient with the high and low airway pressure being coordinated with the spontaneous respiration of the patient.

Claims

1. A method of providing breathing gas from a source for breathing by a patient who is breathing in repeated breathing cycles each including an inspiratory phase and an expiratory phase comprising the steps of:

supplying such breathing gas to the airway of such a patient at a positive pressure at least equal to ambient atmospheric pressure to maintain the patient'"'"'s airway at a positive pressure substantially continuously throughout said repeated breathing cycles;

continually monitoring the flow of such breathing gas between such a source and the airway of such a patient;

from said monitoring, continually determining the instantaneous flow rate and the average flow rate of such breathing gas flowing between such a source and the airway of such a patient;

utilizing said instantaneous flow rate and said average flow rate to identify the occurrence of said inspiratory and expiratory phases; and

coordinating the patient'"'"'s airway pressure with said occurrence of each said inspiratory and expiratory phase to maintain said positive pressure in the patient'"'"'s airway substantially continuously during a sequence of said inspiratory and said expiratory phases with the magnitude of said positive pressure maintained during each said expiratory phase of said sequence being less than the magnitude of said positive pressure maintained during each immediately preceding inspiratory phase, respectively.

2. The method as set forth in claim 1 wherein said supplying step includes the supplying of breathing gas under pressure via a breathing appliance worn by such a patient.

3. A method of medical treatment for a patient comprising the steps of:

providing a flow of breathing gas from a source for delivery to the airway of such a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure;

continually detecting the instantaneous flow rate of said breathing gas flowing between said source and the airway of such a patient;

continually processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of breathing gas flowing between said source and said patient; and

utilizing said instantaneous flow rate and said reference indicia to select

one of said higher and said lower pressure magnitudes for said flow of breathing gas to be applied in the airway of such a patient.

4. The method as set forth in claim 3 including the additional step of continually repeating said selecting steps.

5. The method as set forth in claim 3 wherein said flow of breathing gas is a continuous flow of breathing gas.

6. The method as set forth in claim 3 wherein said selecting step includes selecting said higher pressure magnitude when said instantaneous flow rate is greater than said reference indicia, and selecting said lower pressure magnitude when said instantaneous flow rate is less than said reference indicia.

7. The method as set forth in claim 3 wherein said continually processing step includes adjusting a previously determined value of said reference indicia to provide an adjusted value thereof.

8. The method as set forth in claim 7 wherein said previously determined value of said reference indicia is included among said selected parameters.

9. The method as set forth in claim 8 wherein said continually processing step includes first processing of said instantaneous flow rate to provide a time average of the flow rate of breathing gas resulting from said providing step as a first component of said reference indicia.

10. The method as set forth in claim 9 wherein said continually processing step additionally includes second processing of said instantaneous flow rate and said reference indicia to provide a measure of the net flow of breathing gas to such a patient for each spontaneous patient breath as a second component of said reference indicia.

11. The method as set forth in claim 10 wherein said continually processing step additionally includes third processing of said instantaneous flow rate and the occurrence of said selecting step to provide a measure of the instantaneous flow rate at the end of selected patient expiratory cycles as a third component of said reference indicia.

12. The method as set forth in claim 11 wherein said first, second and third processig steps are carried out simultaneously.

13. The method as set forth in claim 12 wherein said simultaneous first, second and third processing steps are carried out repetitively.

14. The method as set forth in claim 13 wherein said third processing step overrides said second processing step when said measure of the instantaneous flow rate at the end of said selected patient expiratory cycles differs from said reference indicia.

15. The method as set forth in claim 3 wherein said providing step includes providing said flow of breathing gas via a breathing gas delivery appliance worn by such a patient.

16. An apparatus for delivering pressurized gas to the airway of a patient who is breathing in repeated breathing cycles each including an inspiratory phase and an expiratory phase comprising:

a gas flow generator means for providing a flow of such gas;

means for delivery of such gas flow from said flow generator to the airway of such a patient;

pressure controller means cooperable with said flow generator means to provide such gas flow within said means for delivery and within the airway of such a patient at selectively variable pressures;

detector means for continually detecting the rate of flow of such gas between said flow generator means and the airway of such a patient;

first processor means cooperable with said detector means to continually provide a first indicia corresponding to the instantaneous flow rate of such gas between said flow generator means and the airway of such a patient;

second processor means cooperable with said first processor means to continually provide a reference indicia approximating the average flow rate of such gas between said flow generator means and the airway of such a patient;

decision means operable to utilize said first indicia and said reference indicia to identify the occurrence of said inspiratory and expiratory phases; and

said decision means being cooperable with said pressure controller means to control variation of the pressure of such gas flow in response to identification of the occurrence of said inspiratory and expiratory phases.

17. The apparatus as set forth in claim 16 wherein said decision means is operable to adjust said pressure controller means to provide a higher pressure gas flow when said first indicia exceeds said reference indicia, and to provide a lower pressure gas flow when said first indicia is less than said reference indicia.

18. The apparatus as set forth in claim 17 wherein said second processor means includes processing elements operable to adjust an existing value of said reference indicia to provide an adjusted value thereof.

19. The apparatus as set forth in claim 18 wherein said processing elements include means for processing said first indicia to provide a time average of the flow rate of gas as a first component of said reference indicia.

20. The apparatus as set forth in claim 19 wherein said processing elements further include means for processing said first indicia and said reference indicia to provide a measure of such gas flow during a predeterminable time period as a second component of said reference indicia.

21. The apparatus as set forth in claim 20 wherein said predeterminable time period is a single complete breathing cycle of such a patient including one inspiratory cycle and one expiratory cycle in sequence.

22. The apparatus as set forth in claim 21 wherein said processing elements further include means for processing said first indicia and to provide a measure of the value of said first indicia at the end of any such complete breathing cycle by such a patient as a third component of said reference indicia.

23. A method of treating sleep apnea comprising the steps of:

providing breathing gas from a source for breathing by a patient;

supplying such breathing gas to the airway of such a patient;

monitoring the flow rate of such breathing gas between such a source and the airway of such a patient;

from said monitoring, continually determining the instantaneous flow rate and the average flow rate of such breathing gas flowing between such a source and the airway of such a patient;

utilizing said instantaneous flow rate and said average flow rate to identify the occurrence of each inspiratory and expiratory phase of the patient'"'"'s respiration cycle; and

coordinating the patient'"'"'s airway pressure with said occurrence of each said inspiratory and expiratory phase to maintain positive pressure in the patient'"'"'s airway substantially continuously during a sequence of said inspiratory and said expiratory phases with the magnitude of said positive pressure maintained during each said expiratory phase of said sequence being less than the magnitude of said positive pressure maintained during each immediately preceding inspiratory phase, respectively.

24. A method of treating sleep apnea comprising the steps of:

providing a flow of breathing gas from a source for delivery to the airway of a patient at selected higher and lower pressure magnitudes at least as great as ambient atmospheric pressure;

continually detecting the instantaneous flow rate of said breathing gas flowing between said source and the airway of such a patient;

continually processing selected parameters including said instantaneous flow rate to provide a reference indicia corresponding to an average flow rate of breathing gas flowing between said source and said patient; and

utilizing said instantaneous flow rate and said reference indicia to select

one of said higher and said lower pressure magnitudes for said flow of breathing gas.

25. A method of treating sleep apnea comprising the steps of:

substantially continuously providing breathing gas at positive pressure of a magnitude at least equal to ambient atmospheric pressure to the airway of a patient; and

coordinating the patient'"'"'s airway pressure with the occurrence of alternating inspiratory and expiratory phases of the patient'"'"'s respiration to maintain said positive pressure in the patient'"'"'s airway substantially continuously during a sequence of said inspiratory and expiratory phases with the magnitude of said positive pressure maintained during each of said expiratory phases being less than the magnitude of said positive pressure maintained during the immediately preceding ones of said inspiratory phases, respectively.

26. A method of treating sleep apnea in a spontaneously breathing patient comprising the steps of:

substantially continuously providing breathing gas at positive pressure of a magnitude at least equal to ambient atmospheric pressure to the airway of the patient; and

coordinating the magnitude of said positive pressure of said breathing gas in the patient'"'"'s airway with the occurrence of alternating spontaneous inspiratory and expiratory phases of respiration by the patient to maintain said positive pressure in the patient'"'"'s airway substantially continuously during a sequence of said spontaneous inspiratory and expiratory phases with the magnitude of said positive pressure maintained during each of said expiratory phases being less than the magnitude of said positive pressure maintained during the immediately preceding ones of said inspiratory phases, respectively.