Method and apparatus for optimizing the continuous positive airway pressure for treating obstructive sleep apnea

• US 5,490,502 A
• Filed: 05/20/1994
• Issued: 02/13/1996
• Est. Priority Date: 05/07/1992
• Status: Expired due to Term

• Current Assignee: Puritan Bennett Corp. (Medtronic Plc), New York University
• Original Assignee: New York University
• Inventors: Norman, Robert G., Rapoport, David M.
• Primary Examiner(s): Burr, Edgar S.
• Assistant Examiner(s): RACITI, ERIC
• Application Number:
  US08/246,964
• Time in Patent Office: 634 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/204.26, 128/205.18, 128/207.18, 128/716-726
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 5/6803 Head-worn items, e.g. helmets, masks, headphones or goggles
• CPC Class Codes: A61B 5/7239 using differentiation including higher order derivatives
• 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 16/0677 Gas-saving devices therefor
• 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 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 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/62 Posture
• CPC Class Codes: A61M 39/228 with a tubular diaphragm constrictable by radial fluid force
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

In the treatment of obstructive sleep apnea, a method and apparatus are disclosed for optimizing the controlled positive pressure to minimize the flow of air from a flow generator while still ensuring that flow limitation in the patient'"'"'s airway does not occur. In particular, the invention relates to a breathing device and method of use to adjust a controlled positive pressure to the airway of a patient by detecting flow limitation from analysis of an inspiratory flow waveform. Once the presence of flow limitation has been analyzed, the system determines an action to take for adjustment of the controlled positive pressure. The pressure setting is raised, lowered or maintained depending on whether flow limitation has been detected and on the previous actions taken by the system. The preferred breathing apparatus consists of a flow generator, a flow sensor, an analog to digital converter, a microprocessor, and a pressure controller, a patient supply hose, a nasal fitting, and, optionally, a pressure transducer. Using the method of the present invention, the microprocessor adjusts the air pressure in the patient supply hose when flow limitation is detected in the airway of the patient.

Claims

1. A method for optimizing the positive airway pressure to a patient, comprising the steps of:

a) applying an initial level of positive airway pressure of a breathing gas to a patient;

b) detecting the onset of an inspiratory flow of breathing gas to the patient;

c) storing data values representative of the inspiratory flow of breathing gas to the patient;

d) determining whether the stored data values indicate a flow limitation in the patient; and

e) increasing the positive airway pressure when the stored data values indicate a flow limitation in the patient.

2. The method of claim 1, further comprising the step of decreasing the positive airway pressure when the stored data values do not indicate a flow limitation in the patient.

3. The method of claim 1, wherein step d) includes comparing the stored data values with a sinusoidal contour.

4. The method of claim 3, wherein step d) includes correlating the stored data values with a pure sine wave.

5. The method of claim 1, wherein step d) includes analyzing the stored data values for flatness.

6. The method of claim 5, wherein step d) includes comparing a regression fit of the stored data values with a regression fit of a pure sine wave.

7. The method of claim 1, wherein step d) includes analyzing the stored data values for respiratory effort.

8. The method of claim 7, wherein step d) includes comparing a peak value of the stored data values with a peak value of a derivative of the stored data values.

9. The method of claim 1, wherein step d) includes analyzing the stored data values for relative flow magnitude.

10. The method of claim 9, further comprising repeating steps b) through d) for a plurality of patient inspirations to create a plurality of peak flow values for flow limited breaths and to create a plurality of peak flow values for non-flow limited breaths, and comparing a peak value of the stored data values with an average of the plurality of peak flow values for flow limited breaths and with an average of the plurality of peak flow values for non-flow limited breaths.

11. The method of claim 1, further comprising the steps of:

f) repeating steps b) through d) for a plurality of patient inspirations to create a plurality of peak flow values for flow limited breaths and to create a plurality of peak flow values for non-flow limited breaths;

g) correlating the stored data values with a pure sine wave to create a first index;

h) comparing a regression fit of the stored data values with a regression fit of a pure sine wave to create a second index;

i) comparing a peak value of the stored data values with a peak value of a derivative of the stored data values to create a third index; and

j) comparing a peak value of the stored data values with an average of the plurality of peak flow values for flow limited breaths and with an average of the plurality of peak flow values for non-flow limited breaths to create a fourth index.

12. The method of claim 11, wherein step d) further includes the step of calculating a fifth index as a function of the first index, the second index, the third index and the fourth index, wherein the fifth index indicates the presence of flow limitation in the patient.

13. The method of claim 12, wherein step d) further includes the step of calculating a fifth index as a mathematical function of the first index, the second index, the third index and the fourth index, wherein each index includes a weighted coefficient having a range including a value of zero.

14. A method for optimizing the positive airway pressure to a patient, comprising the steps of:

a) applying an initial level of positive airway pressure of a breathing gas to a patient;

b) detecting the onset of an inspiratory flow of breathing gas to the patient;

c) storing an inspiratory flow waveform of breathing gas to the patient;

d) determining whether the stored inspiratory flow waveform indicates a flow limitation in the patient;

e) repeating steps b) through d) for a plurality of patient inspirations to create a plurality of peak flow values for flow limited breaths and to create a plurality of peak flow values for non-flow limited breaths;

f) correlating the inspiratory flow waveform with a pure sine wave to create a first index;

g) comparing a regression fit of the inspiratory flow waveform with a regression fit of a pure sine wave to create a second index;

h) comparing a peak value of the inspiratory flow waveform with a peak value of a derivative of the inspiratory flow waveform to create a third index;

i) comparing a peak value of the inspiratory flow waveform with an average of the plurality of peak flow values for flow limited breaths and with an average of the plurality of peak flow values for non-flow limited breaths to create a fourth index;

j) calculating a fifth index as a mathematical function of the first index, the second index, the third index and the fourth index, wherein each index includes a weighted coefficient having a range including a value of zero; and

k) increasing the positive airway pressure when the fifth index indicates a flow limitation in the patient.

15. A method for optimizing the positive airway pressure to a patient, comprising the steps of:

a) applying an initial level of positive airway pressure of a breathing gas to a patient;

b) monitoring a first inspiratory flow of breathing gas to the patient;

c) determining a first index indicative of whether the first inspiratory flow reveals a previous flow limitation in the patient;

d) monitoring a second inspiratory flow of breathing gas to the patient;

e) determining a second index indicative of whether the second inspiratory flow reveals a present flow limitation in the patient;

f) calculating a majority function using the first index and the second index; and

g) increasing the level of positive airway pressure when the second index and the majority function indicate a continued flow limitation in the airway of the patient.

16. The method of claim 15, further comprising the step of decreasing the level of positive airway pressure when the second index and the majority function indicate an absence of flow limitation in the airway of the patient.

17. The method of claim 16, wherein the level of positive airway pressure is further adjusted by determining whether the level of positive airway pressure was previously raised, lowered or held at the same value.

18. The method of claim 15, wherein the majority function is calculated by determining the first index from data values representative of at least two waveforms of inspiratory flow to the patient.

19. A breathing device for optimizing the positive airway pressure to a patient, comprising:

means for applying an initial level of positive airway pressure of a breathing gas to a patient;

means for storing data values representative of the inspiratory flow of breathing gas to the patient;

means for determining whether the stored data values indicate a flow limitation in the patient; and

means for increasing the positive airway pressure when the stored data values indicate a flow limitation in the patient.

20. The breathing device of claim 19, wherein said means for determining includes processing means for determining a plurality of peak inspiratory flow values for flow limited breaths, for determining a plurality of peak inspiratory flow values for non-flow limited breaths, for correlating the stored data values with a pure sine wave to create a first index, for comparing a regression fit of the stored data values with a regression fit of a pure sine wave to create a second index, for comparing a peak value of the stored data values with a peak value of a derivative of the stored data values to create a third index, and for comparing a peak value of the stored data values with an average of the plurality of peak flow values for flow limited breaths and with an average of the plurality of peak flow values for non-flow limited breaths to create a fourth index.

21. The breathing device of claim 20, wherein the processing means further includes means for calculating a fifth index as a mathematical function of the first index, the second index, the third index and the fourth index, wherein each index includes a weighted coefficient having a range including a value of zero.

22. The breathing device of claim 19, wherein said means for determining includes processing means for correlating the stored data values with a sinusoidal contour, analyzing the stored data values for flatness, analyzing the stored data values for respiratory effort, and analyzing the stored data values for relative flow magnitude.

23. The breathing device of claim 22, wherein said processing means includes a microprocessor.

24. The breathing device of claim 23, wherein said means for storing includes random access memory associated with the microprocessor.

25. The breathing device of claim 24, wherein said means for applying includes a blower driven by a motor, and said means for increasing includes a motor speed controller.

26. The breathing device of claim 24, wherein said means for applying includes a positive pressure source of breathing gas and a nasal fitting having a vent in fluid communication with the source of breathing gas, and said means for increasing includes a pressure control valve.

27. A breathing device for optimizing the positive airway pressure to a patient, comprising:

a source of breathing gas at controlled positive pressure to the airway of a patient;

a flow sensor configured to generate first data values representative of an inspiratory flow of breathing gas to the patient;

computer memory configured to store the first data values generated by said flow sensor;

a microprocessor configured to generate a first signal when the first data values indicate a flow limitation in the patient; and

a pressure controller responsive to the first signal from said microprocessor and coupled to said source of breathing gas for increasing the positive pressure to the airway of the patient.

28. The breathing device of claim 27, wherein said microprocessor is further configured to cause said pressure controller to decrease the positive pressure to the airway of the patient when the first data values do not indicate a flow limitation in the patient.

29. The breathing device of claim 27, further comprising a pressure sensor configured to generate second data values representative of the controlled positive pressure of breathing gas to the patient, wherein said computer memory is further configured to store the second data values.

30. The breathing device of claim 27, wherein said microprocessor includes means for correlating the first data values with a pure sine wave.

31. The breathing device of claim 27, wherein said microprocessor includes means for comparing a regression fit of the first data values with a regression fit of a pure sine wave.

32. The breathing device of claim 27, wherein said microprocessor includes means for comparing a peak value of the first data values with a peak value of a derivative of the first data values.

33. The breathing device of claim 27, wherein said microprocessor includes means for determining a plurality of peak flow values for flow limited breaths, for determining a plurality of peak flow values for non-flow limited breaths, and for comparing a peak value of the first data values with an average of the plurality of peak flow values for flow limited breaths and with an average of the plurality of peak flow values for non-flow limited breaths.

34. An apparatus for providing breathing gas to the airway of a patient, comprising:

a source of breathing gas at positive pressure to the airway of a patient;

a sensor configured to generate data values representative of inspiratory flow of breathing gas to the patient;

a memory device configured to store first data values generated by said sensor, and to store second data values generated by said sensor;

processing means coupled to said memory device for determining a first index indicative of whether the first data values reveal a first flow limitation in the patient, said processing means further configured to determine a second index indicative of whether the second data values reveal a second flow limitation in the patient and to calculate a majority function using the first index and the second index; and

a pressure controller in operative relationship with said source of breathing gas, said pressure controller responsive to said processing means so as to increase the positive pressure to the airway of the patient when the second index and the majority function indicate a continued flow limitation in the airway of the patient.

35. The apparatus of claim 34, wherein said processing means is configured to cause said pressure controller to decrease the positive pressure to the airway of the patient when the second index and the majority function indicate an absence of flow limitation in the airway of the patient.

36. The apparatus of claim 35, wherein said processing means is configured to further adjust the positive pressure to the airway of the patient by determining whether the positive pressure was previously raised, lowered or held at the same value.