Sleep apnea treatment apparatus

• US RE35,295 E
• Filed: 08/24/1994
• Issued: 07/16/1996
• Est. Priority Date: 09/22/1989
• Status: Expired due to Term

• Current Assignee: RIC INVESTMENTS LLC (Respironics Incorporated)
• Original Assignee: Respironics Incorporated
• Inventors: Estes, Mark C., Cattano, Janice M.
• Primary Examiner(s): Asher, Kimberly L.
• Application Number:
  US08/296,018
• Time in Patent Office: 692 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/716, 128/719
• US Class Current: 128/204.23
• 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 16/024 including calculation means, e.g. using a processor
• CPC Class Codes: A61M 16/204 used for inhalation control
• CPC Class Codes: A61M 16/205 used for exhalation 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 2205/3561 local, e.g. within room or hospital

Abstract

Improved methodology and apparatus for the treatment of sleep apnea through (1) 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, (2) usage of adjustably programmable pressure ramp circuitry capable of producing multiple pressure ramp cycles of predetermined duration and pattern whereby the ramp cycles may be customized to accommodate the specific needs of an individual sleep apnea patient so as to ease the patient'"'"'s transition from wakefulness to sleep, and (3) remote control operation of the apparatus for assisting those patients whose mobility or capacity for physical exertion is intrinsically limited.

Claims

1. 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, said apparatus comprising:

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

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

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

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

processor means cooperable with said detector means for continually providing flow rate information of said gas between said gas flow generator means and the airway of the patient, said flow rate information including a first indicia corresponding to the instantaneous flow rate of said gas and a reference indicia approximating the average flow rate of said gas;

decision means operable to utilize said first indicia and said reference indicia to identify the occurrence of said inspiratory and expiratory phases, said decision means being cooperable with said pressure controller means to control variation of the pressure of said gas flow in response to identification of the occurrence of said inspiratory and expiratory phases; and

ramp control circuitry means operatively connected to said pressure controller means for effecting (1) a first ramp cycle wherein said gas flow from said pressure controller means is initially output at a first pressure and raises with time to a second pressure, and (2) at least one additional ramp cycle selectively activatable through conscious action of the patient.

2. The apparatus of claim 1 wherein said decision means is operable to adjust said pressure controller means for a higher pressure gas flow within said means for delivery when said first indicia exceeds said reference indicia, and for a lower pressure gas flow within said means for delivery when said first indicia is less than said reference indicia.

3. The apparatus of claim 2 wherein said processor means includes processing elements operable to adjust an existing value of said reference indicia to provide an adjusted value thereof.

4. The apparatus of claim 3 wherein said processing elements include means for processing said first indicia to provide a time average of the flow rate of gas within said means for delivery as a first component of said reference indicia.

5. The apparatus of claim 4 wherein said processing elements further include means for processing said first indicia and said reference indicia to provide a measure of the flow of gas within said means for delivery during a predeterminable time period as a second component of said reference indicia.

6. The apparatus of claim 5 wherein said predeterminable time period is a single complete breathing cycle of the patient including one said inspiratory phase and one said expiratory phase in sequence.

7. The apparatus of claim 6 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 said complete breathing cycle by the patient as a third component of said reference indicia.

8. The apparatus of claim 1 further comprising means associated with said ramp control circuitry means for adjusting the magnitude of said first pressure.

11. The apparatus of claim 1 further comprising means associated with said ramp control circuitry means for adjusting the duration of said first ramp cycle.

12. The apparatus of claim 11 further comprising means associated with said ramp control circuitry means for selecting a fraction of an adjusted duration of said first ramp cycle as established by said means for adjusting the duration of said first ramp cycle.

13. The apparatus of claim 12 wherein said means for selecting a fraction of an adjusted duration of said first ramp cycle permits selection of a fraction of said adjusted duration from zero up to and including said adjusted duration.

14. The apparatus of claim 12 further comprising means associated with said ramp control circuitry means for adjusting the duration of said at least one additional ramp cycle.

15. The apparatus of claim 14 wherein said means for adjusting the duration of said at least one additional ramp cycle permits adjustment of the duration of said at least one additional ramp cycle from substantially zero up to and including said adjusted duration.

16. The apparatus of claim 1 further comprising means associated with said ramp control circuitry means for establishing a predetermined pattern of pressure output from said pressure controller means during progression from said first pressure to said second pressure.

17. The apparatus of claim 16 further comprising means associated with said ramp control circuitry means for establishing a pattern of pressure output from said pressure controller means different than said predetermined pattern during said at least one additional ramp cycle.

18. The apparatus of claim 1 further comprising remote control means operable by the patient for selectively activating said apparatus and said ramp control circuitry means.

19. The apparatus of claim 18 where said remote control means includes a first actuator having a first configuration and adapted to be operated by the patient to activate said apparatus and a second actuator having a second configuration substantially different than said first configuration and adapted to activate said ramp control circuitry means, whereby the patient can reliably identify and operate said first and second actuators by sense of touch.

9. The apparatus of claim I further comprising means associated with said ramp control circuitry means for adjusting the magnitude of said second pressure.

10. The apparatus of claim 9 where said second pressure is a prescription pressure unique to the patient.

20. 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, said apparatus comprising:

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

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

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

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

processor means cooperable with said detector means for continually providing flow rate information of said gas between said gas flow generator means and the airway of the patient, said flow rate information including a first indicia corresponding to the instantaneous flow rate of said gas and a reference indicia approximating the average flow rate of said gas;

decision means operable to utilize said first indicia and said reference indicia to identify the occurrence of said inspiratory and expiratory phases, said decision means being cooperable with said pressure controller means to control variation of the pressure of said gas flow in response to identification of the occurrence of said inspiratory and expiratory phases;

ramp control circuitry means operatively connected to said pressure controller means for effecting (1) a first ramp cycle wherein said gas flow from said pressure controller means is initially output at a first pressure and raises with time to a second pressure, and (2) at least one additional selectively activatable ramp cycle;

means associated with said ramp control circuitry means for adjusting the magnitude or said first pressure;

means associated with said ramp control circuitry means for adjusting the magnitude of said second pressure;

means associated with said ramp control circuitry means for adjusting the duration of said first ramp cycle;

means associated with said ramp control circuitry means for selecting a fraction of an adjusted duration of said first ramp cycle as established by said means for adjusting the duration of said first ramp cycle;

means associated with said ramp control circuitry means for adjusting the duration of said at least one additional ramp cycle;

means associated with said ramp control circuitry means for establishing a predetermined pattern of pressure output from said pressure controller means during progression from said first pressure to said second pressure; and

remote control means operable by the patient for selectively activating said apparatus and said ramp control circuitry means.

21. The apparatus of claim 20 further comprising means associated with said ramp control circuitry means for establishing a pattern of pressure output from said pressure controller means different than said predetermined pattern during said at least one additional ramp cycle.

22. Apparatus for delivering pressurized gas to the airway of a patient, said apparatus comprising:

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

conduit means for delivery of said gas flow to the airway of said patient;

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

ramp control circuitry means operatively connected to said pressure controller means for effecting (1) a first ramp cycle wherein said gas flow from said pressure controller means is initially output at a first pressure and raises with time to a second pressure, and (2) at least one additional ramp cycle selectively activatable through conscious action of said patient; and

means associated with said ramp control circuitry means for adjusting the duration of said first ramp cycle; and

means associated with said ramp control circuitry means for selecting a fraction of an adjusted duration of said first ramp cycle as established by said means for adjusting the duration of said first ramp cycle.

23. The apparatus of claim 22 further comprising means associated with said ramp control circuitry means for adjusting the magnitude of said first pressure.

24. The apparatus of claim 22 further comprising means associated with said ramp control circuitry means for adjusting the magnitude of said second pressure.

25. The apparatus of claim 24 wherein said second pressure is a prescription pressure unique to the patient.

26. The apparatus of claim 22 wherein said means selecting a fraction of an adjusted duration of said first ramp cycle permits selection of a fraction of said adjusted duration from zero up to and including said adjusted duration.

27. The apparatus of claim 22 further comprising means associated with said ramp control circuitry means for adjusting the duration of said at least one additional ramp cycle.

28. The apparatus of claim 27 wherein said means for adjusting the duration of said at least one additional ramp cycle permits adjustment of the duration of said at least one additional ramp cycle from substantially zero up to and including said adjusted duration.

29. The apparatus of claim 22 further comprising means associated with said ramp control circuitry means for establishing a predetermined pattern of pressure output from said pressure controller means as said pressure progresses from said first pressure to said second pressure.

30. The apparatus of claim 29 further comprising means associated with said ramp control circuitry means for establishing a pattern of pressure output from said pressure controller means different than said predetermined pattern during said at least one additional ramp cycle.

31. The apparatus of claim 22 further comprising remote control means operable by the patient for selectively activating said apparatus and said ramp control circuitry means.

32. The apparatus of claim .[.22.]. .Iadd.31 .Iaddend.wherein said remote control means includes a first actuator having a first configuration and adapted to be operated by the patient to activate said apparatus and a second actuator having a second configuration substantially different than said first configuration and adapted to activate said ramp control circuitry means, whereby the patient can reliably identify and operate said first and second actuators by sense of touch.

33. Apparatus for delivering pressurized gas to the airway of a patient, said apparatus comprising:

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

conduit means for delivery of said gas flow to the airway of the patient;

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

ramp control circuitry means operatively connected to said pressure controller means for effecting (1) a first ramp cycle wherein said gas flow from said pressure controller means is initially output at a first pressure and raises with time to a second pressure, and (2) at least one additional selectively activatable ramp cycle;

means associated with said ramp control circuitry means for adjusting the magnitude of said first pressure;

means associated with said ramp control circuitry means for adjusting the magnitude of said second pressure;

means associated with said ramp control circuitry means for adjusting the duration of said first ramp cycle;

means associated with said ramp control circuitry means for selecting a fraction of an adjusted duration of said first ramp cycle as established by said means for adjusting the duration of said first ramp cycle;

means associated with said ramp control circuitry mans for adjusting the duration of said at least one additional ramp cycle;

means associated with said ramp control circuitry means for establishing a predetermined pattern of pressure output from said pressure control means during progression from said first pressure to said second pressure; and

remote control means operable by the patient for selectively activating said apparatus and said ramp control circuitry means.

34. The apparatus of claim 33 further comprising means associated with said ramp control circuitry means for establishing a pattern of pressure output from said pressure controller means different than said predetermined pattern during said at least one additional ramp cycle.