Method for the diagnosis of sleep apnea

• US 5,605,151 A
• Filed: 02/21/1995
• Issued: 02/25/1997
• Est. Priority Date: 08/19/1992
• Status: Expired due to Term

• Current Assignee: Lawrence A. Lynn
• Original Assignee: Lawrence A. Lynn
• Inventors: Lynn, Lawrence A.
• Primary Examiner(s): Sykes, Angela D.
• Assistant Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US08/391,811
• Time in Patent Office: 735 Days
• Field of Search: 128/633, 128/670, 128/671, 128/716, 128/719, 128/721
• US Class Current: 600/323
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise

Abstract

A device for diagnosing sleep apnea by identifying desaturation and resaturation events in oxygen saturation of a patient'"'"'s blood. The slope of the events is determined and compared against various information to determine sleep apnea.

Claims

1. A method of evaluating a patient for diagnosis of sleep apnea using an oximeter having a sensor, the method comprising steps of:

(1) disposing said oximeter sensor adjacent a human body part, said oximeter having an output signal indicating an oxygen saturation of a patient'"'"'s blood and a processor element responsive to said signal indicating oxygen saturation, and generating an oxygen saturation waveform as a function of time,

(2) using a computer for;

a) repetitively calculating slopes along said oxygen saturation waveform,

b) continuously comparing said slopes to a first predetermined range of slopes and identifying a first slope comprising a desaturation slope which falls within said first predetermined range of slopes,

c) further comparing said slopes to a second predetermined range of slopes and said computer identifying a second slope comprising a resaturation slope which falls within the second predetermined range of slopes, immediately following said desaturation slope,

d) comparing said desaturation slope to said resaturation slope to identify at least one coupled pair of desaturation and resaturation slopes wherein said comparison yields a result consistent with said coupled pair of slopes being induced by sleep apnea,

e) continuously repeating at least steps b through d along said waveform,

(3) using at least said comparing step d) to determine the diagnosis of sleep apnea.

2. The method of claim 1 further including using said computer for the steps of:

a) defining a time interval subsequent at least one of said desaturation slope and said resaturation slope,

b) further comparing said slopes to a third predetermined range of slopes and identifying a third slope, comprising a desaturation slope falling within said third predetermined range of slopes, within said time interval,

c) using said identification of said third desaturation slope in addition to said comparing of said coupled slopes to determine said diagnosis of sleep apnea.

3. The method of claim 2 further including using said computer for the steps of:

a) comparing said third slope to said first slope,

b) using said comparing of said third slope to said first slope in addition to said comparing of said coupled slopes to determine said diagnosis of sleep apnea.

4. The method of claim 1 further including using said computer for the steps of:

a) defining a time interval subsequent at least one of said first desaturation slope and said resaturation slope,

b) identifying a second pair of said coupled slopes within said interval,

c) using said identification of said second coupled pair of slopes in addition to said comparing of said first coupled pair of slopes to determine said diagnosis of sleep apnea.

5. The method of claim 1 wherein said comparing of said coupled slopes comprises the step of using said computer to calculate a ratio of said slopes.

6. The method of claim 5 including using said computer to compare said ratio to a range of slope ratios consistent with said coupled slopes being induced by sleep apnea.

7. The method of claim 1 further including steps of:

a) disposing at least a second sensor having an output indicating patient exhaled gas flux in juxtaposition with said patient,

b) using said second sensor output in addition to said comparing step d) to determine said sleep apnea diagnosis.

8. The method of claim 1 further including the step of:

1) administering positive pressure through a patient'"'"'s nasal pharynx,

2) activating said positive pressure upon at least the identification of said coupled pair of slopes,

3) repeating at least steps a and b subsequent said activation to determine the efficacy of said positive pressure in mitigating further said desaturation slopes.

9. The method of claim 8 wherein step 3 further comprises the step of repeating steps a through e subsequent said activation of said positive pressure.

10. A method of evaluating a patient for diagnosis of sleep apnea using an oximeter having a sensor, the method of comprising steps of:

a) disposing said oximeter sensor adjacent a human body part, said oximeter having an output signal indicating an oxygen saturation of a patient'"'"'s blood and processor element responsive to said signal indicating oxygen saturation, and generating an oxygen saturation waveform as a function of time,

b) defining a primary interval for calculation of a slope of oxygen saturation as a function of time,

c) using a computer for continuously calculating said slope along said waveform over said interval, and

d) identifying a first slope, comprising a desaturation slope, which falls within a first predetermined slope range, and,

e) identifying a second slope, comprising a resaturation slope, which falls within a second predetermined slope range, immediately following said desaturation slope,

f) mathematically comparing, using said computer, said desaturation slope to said resaturation slope to identify at least one coupled pair of desaturation and resaturation slopes consistent with sleep apnea,

g) continuously repeating steps b through f along said waveform;

h) using at least said step of mathematically comparing to determine the diagnosis of sleep apnea.

11. The method of claim 10, wherein the step of defining a primary interval comprises the step of defining a primary time interval.

12. The method of claim 11 wherein the step of defining a primary time interval comprises the step of defining a time interval of less than, or about equal to, 12 seconds.

13. The method of claim 11 wherein the step of defining a primary interval comprises the step of defining a time interval of less than, or about equal to, 3 seconds.

14. The method of claim 10 wherein said oximeter is a pulse oximeter capable of detecting a cardiovascular pulse of a patient, the step of defining a primary interval comprising the step of defining said interval as a function of a cardiovascular pulse rate of said patient.

15. The method of claim 10 wherein the step of defining said interval comprises said interval being defined by consecutive cardiovascular pulses of the patient.

16. A method of evaluating a patient for diagnosis of sleep apnea comprising steps of:

a) using a pulse oximeter to detect the cardiovascular pulse of a patient, said oximeter having a sensor, said oximeter having an output signal indicating an oxygen saturation of a patient'"'"'s blood and a processor element responsive to said signal indicating oxygen saturation and generating an oxygen saturation waveform as a function of time,

b) disposing said pulse oximeter sensor adjacent a human body part,

c) defining an interval for calculation of a slope of oxygen saturation,

d) using a computer for repetitively calculating sequential slopes along said waveform at said interval, and for,

e) identifying a first slope, comprising a desaturation slope, which falls within a first predetermined slope range, and for,

f) identifying a second slope, comprising a resaturation slope, which falls within a second predetermined slope range, immediately following said desaturation slope,

g) mathematically comparing, using said computer, said desaturation slope to said resaturation slope to identify at least one coupled pair of desaturation and resaturation slopes consistent with sleep apnea,

h) automatically repeating at least steps c through f

i) determining the diagnosis of sleep apnea based on at least said comparing.

17. The method of claim 16 further including the step of:

1) using said computer to define said interval, said interval being variable,

2) repeating steps b through f, using said interval, to determine the diagnosis of sleep apnea.

18. The method of claim 17 wherein the step of defining said interval comprises the step of defining said interval as a function of a cardiovascular pulse rate of said patient.

19. The method of claim 16 wherein said comparing of said coupled slopes comprises the step of calculating a ratio of said slopes.

20. The method of claim 16 further including steps of:

a) disposing at least a second sensor having an output indicating patient exhaled gas flux in juxtaposition with said patient,

b) using said second sensor output in addition to said comparing to determine said sleep apnea diagnosis.

21. The method of claim 16 further including the step of repetitively calculating substantially all sequential slopes along said waveform using said interval.

22. The method of claim 17 wherein the step of defining said interval further includes the step of defining said interval as a function of consecutive cardiovascular pulses of said patient, said interval for said calculation of said sequential slopes changing with a pulse rate of said patient.

23. A method of evaluating a patient for diagnosis of sleep apnea using an oximeter having a sensor, the method of comprising steps of:

1) disposing said oximeter sensor adjacent a human body part, said oximeter having an output signal indicating an oxygen saturation of a patient'"'"'s blood and a processor element responsive to said signal indicating oxygen saturation and generating an oxygen saturation waveform as a function of time,

2) using a computer for;

a) repetitively calculating slopes along said oxygen saturation waveform,

b) continuously comparing said slopes to a first predetermined range of slopes and identifying a first slope comprising a desaturation slope which falls within said first predetermined range of slope,

c) further comparing said slopes to a second predetermined range of slopes and said computer identifying a second slope comprising a resaturation slope which falls within the second predetermined range of slopes, immediately following said desaturation slope,

d) comparing said desaturation slope to said resaturation slope to identify at least one coupled pair of desaturation and resaturation slopes wherein said comparison yields a result consistent with said coupled pair of slopes being induced by sleep apnea,

e) continuously repeating at least steps b through d,

f) calculating a frequency of said coupled slopes as a function of time,

g) determining the diagnosis of sleep apnea based on at least said frequency calculation,

h) plotting said oxygen saturation waveform for visual inspection and comparison with said sleep apnea determination.

24. The method of claim 23 further including the step of plotting said slopes of oxygen saturation as a function of time to derive a slope-time waveform for visual inspection and comparison with said sleep apnea diagnosis.

25. The method of claim 23 further including steps of:

a) disposing at least a second sensor having an output indicating patient exhaled gas flux in juxtaposition with said patient,

b) using said second sensor output in addition to said comparing to determine said sleep apnea diagnosis.

26. The method of claim 23 further including steps of:

a) disposing at least a second sensor, in juxtaposition with said patient, said second sensor having an output indicating at least one of the presence or absence of patient exhaled gas movement,

b) using said second sensor output in addition to said comparing to determine said sleep apnea diagnosis.

27. The method of claim 23 further including steps of:

a) disposing at least a second sensor, in juxtaposition with said patient, said second sensor having an output indicating carbon dioxide, said carbon dioxide indicating output further indicating patient exhaled gas flux.

b) using said second sensor output in addition to said comparing to determine said sleep apnea diagnosis.