Method and apparatus useful in the diagnosis of obstructive sleep apnea of a patient

• US 6,770,037 B2
• Filed: 03/04/2002
• Issued: 08/03/2004
• Est. Priority Date: 06/26/1987
• Status: Expired due to Fees

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Lynch, Christopher, Sullivan, Colin Edward
• Primary Examiner(s): Nasser, Robert L.
• Assistant Examiner(s): Mallari, Patricia C.
• Application Number:
  US10/086,444
• Publication Number:
  US 20020100477A1
• Time in Patent Office: 883 Days
• Field of Search: 600/529, 600/532, 600/533, 600/538, 600/586, 73/233, 120/204.18, 120/204.22, 120/204.23, 120/204.26, 120/205.25
• US Class Current: 600/529
• CPC Class Codes: A61B 5/097 Devices for facilitating collection of breath or for directing breath into or through measuring devices
• CPC Class Codes: A61B 5/6814 Head
• CPC Class Codes: A61B 7/003 Detecting lung or respiration noise
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61M 16/0051 with alarm devices
• 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 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 2016/0024 with an on-off output signal, e.g. from a switch
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• 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)
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user

Abstract

Patients may operate a CPAP system to deliver appropriate airway pressure at their home. A patient'"'"'s apnea problem ca be diagnosed at home without supervision with a CPAP device which delivers a continuously minimum appropriate pressure for substantially the entire period of therapy.

Claims

1. An apparatus useful in the diagnosis of obstructive sleep apnea of a patient, the apparatus comprising:

a monitoring apparatus consisting of a sensor apparatus connected to a nasal mask, the sensor providing a signal indicative of at least one respiratory parameter representative of a pre-apneic snoring pattern; and

a controller set to process only the signal to at least detect the pre-apneic snoring assist in the diagnosis of obstructive sleep apnea.

2. An apparatus according to claim 1, wherein the sensor is connected to the nasal mask in sound communication.

3. An apparatus according to claim 1, wherein the at least one respiratory parameter is the patient'"'"'s snoring or flow rate.

4. An apparatus according to claim 1, further comprising a signal recording apparatus configured to record and store the signal over a period of time.

5. An apparatus according to claim 1, wherein the controller is configured to compare the at least one respiratory parameter with a predetermined respiratory parameter pattern and to control pressure within the nasal mask based on the comparison between the at least one respiratory parameter and the predetermined respiratory parameter pattern.

6. An apparatus according to claim 1, wherein the sensor provides the signal while the patient is sleeping substantially unsupervised in a non-clinical setting.

7. An apparatus according to claim 1, wherein the sensor is connected remote from the nasal mask so as to be in pressure communication with the patient'"'"'s respiratory system.

8. An apparatus according to claim 1, wherein the sensor is connected adjacent an air inlet of the nasal mask so as to be in communication with the patient'"'"'s respiratory system.

9. An apparatus according to claim 1, wherein the sensor is a pressure transducer in pressure communication with the nasal mask.

10. An apparatus according to claim 1, wherein the signal is provided to a sleep disorder clinical professional to assist in the diagnosis of obstructive sleep apnea.

11. An apparatus according to claim 1, wherein the controller processes the signal to provide at least one index useful in the diagnosis of obstructive sleep apnea.

12. An apparatus according to claim 11, wherein the at least one index is reviewed to screen the patient for an indication of obstructive sleep apnea.

13. The apparatus of claim 1 wherein the pre-apneic snoring pattern is decreasing snoring intensity.

14. A method of monitoring one respiratory parameter of a patient, the respiratory parameter being useful in the diagnosis of obstructive sleep apnea, the method comprising:

providing a nasal mask to substantially surround the patient'"'"'s nasal passages;

providing the nasal mask with access to a source of breathable gas and to the patient;

providing a monitoring apparatus configured to measure at least one respiratory parameter of the patient to detect a pre-apneic snoring pattern,

the monitoring apparatus consisting essentially of a single sensor in communication with the nasal mask, the sensor being structured to transmit a signal indicative of only a respiratory value of the measured respiratory parameter; and

processing the signal to detect the pre-apneic snoring pattern to assist in the diagnosis of obstructive sleep apnea.

15. A method according to claim 14, further comprising recording and storing the signal over a period of time.

16. A method according to claim 14, further comprising:

comparing the patient'"'"'s respiratory parameter with a predetermined respiratory parameter pattern; and

controlling pressure within the nasal mask based on the comparison between the at least one respiratory parameter and the predetermined respiratory parameter pattern.

17. A method according to claim 14, wherein the sensor is connected to the nasal mask adjacent an air inlet of the nasal mask to provide the signal.

18. A method according to claim 14, wherein the measuring of the patient'"'"'s respiratory parameter is performed while the patient is sleeping substantially unsupervised in a non-clinical setting.

19. A method according to claim 14, wherein the sensor is connected remote from the nasal mask so as to be in communication with the patient'"'"'s respiratory system to provide the signal.

20. A method according to claim 14, further comprising providing the signal to a sleep disorder clinical professional in the diagnosis of obstructive sleep apnea.

21. A method according to claim 14, wherein the processing of the signal provides at least one index useful in the diagnosis of obstructive sleep apnea.

22. A method according to claim 21, further comprising reviewing the index to screen the patient for an indication of obstructive sleep apnea.

23. The method of claim 14 wherein the pre-apneic snoring pattern is decreasing snoring intensity.

24. A method of diagnosing whether a patient has obstructive sleep apnea, comprising:

providing the patient with an apnea monitoring apparatus configured for home use to monitor at least one respiratory parameter of the patient, the apnea monitoring apparatus being in communication with a nasal mask configured to be worn over nasal passages of the patient;

allowing the patient to sleep at home while being monitored by the apnea monitoring apparatus;

generating only data indicative of the at least one respiratory parameter representing a pre-apneic snoring pattern during the patient'"'"'s home sleep;

analyzing the data by detecting the pre-apneic snoring pattern; and

diagnosing the presence of obstructive sleep apnea based at least in part on the data.

25. The method of claim 24 wherein the pre-apneic snoring pattern is decreasing snoring intensity.

26. A method according to claim 24, further comprising recording and storing the data over a period of time.

27. A method according to claim 24, further comprising:

comparing the at least one respiratory parameter of the patient with a predetermined respiratory parameter pattern; and

controlling pressure within the nasal mask based on the comparison between the at least one respiratory parameter and the predetermined respiratory parameter pattern.

28. A method according to claim 24, further comprising:

connecting at least one sensor in communication with the nasal mask, the sensor being configured to provide a signal indicative of only the at least one respiratory parameter; and

processing the signal to assist in the diagnosis of obstructive sleep apnea.

29. A method according to claim 28, further comprising connecting the sensor to the nasal mask adjacent an air inlet of the nasal mask to provide the signal.

30. A method according to claim 28, further comprising connecting the sensor remote from the nasal mask so as to be in communication with the patient'"'"'s respiratory system to provide the signal.

31. A method according to claim 25, wherein the diagnosing comprises providing the data to a sleep disorder clinical professional.

32. A method according to claim 25, wherein the analyzing comprises processing the at least one respiratory parameter to provide at least one index useful in the diagnosis of obstructive sleep apnea.

33. A method according to claim 32, wherein the diagnosing comprises reviewing the index to screen the patient for an indication of obstructive sleep apnea.

34. A method of diagnosing a patient for the condition of obstructive sleep apnea, the method comprising:

monitoring at least one respiratory parameter indicative of a pre-apneic snoring pattern of the patient at home in a non-clinical environment for at least one day or night, the monitoring being accomplished by a monitoring apparatus in communication with a nasal mask the monitoring not including non-respiratory parameters;

generating data indicative of the at least one respiratory parameter; and

diagnosing presence of obstructive sleep apnea based at least in part on the data indicative of the pre-apneic snoring pattern.

35. A method according to claim 34, further comprising recording and storing the data over a period of time.

36. A method according to claim 34, further comprising:

comparing the patient'"'"'s respiratory parameter with a predetermined respiratory parameter pattern; and

controlling pressure within the nasal mask based on the comparison between the at least one respiratory parameter and the predetermined respiratory parameter pattern.

37. A method according to claim 34, further comprising:

connecting a sensor apparatus in communication with the nasal mask, the sensor being configured only to provide a respiratory signal indicative of the at least one respiratory parameter,

processing the signal to assist in the diagnosis of obstructive sleep apnea.

38. A method according to claim 37, further comprising connecting the sensor to the nasal mask adjacent an air inlet of the nasal mask to provide the signal.

39. A method according to claim 37, further comprising connecting the sensor remote from the nasal mask so as to be in communication with the patient'"'"'s respiratory system to provide the signal.

40. A method according to claim 34, wherein the diagnosing comprises providing the signal to a sleep disorder clinical professional.

41. A method according to claim 34, wherein the generating comprises processing the at least one respiratory parameter data to provide at least one index useful in the diagnosis of obstructive sleep apnea.

42. A method according to claim 41, wherein the diagnosing comprises reviewing the index to screen the patient for an indication of obstructive sleep apnea.

43. The method of claim 34 wherein the pre-apneic snoring pattern is decreasing snoring intensity.

44. A method useful in the diagnosis of obstructive sleep apnea of a patient, the method comprising:

providing a monitoring apparatus consisting of essentially a single sensor connected to a nasal mask;

sensing at least one respiratory parameter indicative of a pre-apneic snoring pattern of the patient to provide a signal indicative of the at least one respiratory parameter; and

processing only the signal to detect the pre-apneic snoring pattern to assist in the diagnosis of obstructive sleep apnea.

45. A method according to claim 44, wherein the step of sensing the at least one respiratory parameter is performed while the patient is sleeping substantially unsupervised in a non-clinical setting.

46. A method according to claim 44, further comprising connecting the sensor remote from the nasal mask so as to be in pressure communication with the patient'"'"'s respiratory system.

47. A method according to claim 44, further comprising connecting the sensor adjacent an air inlet of the nasal mask so as to be in communication with the patient'"'"'s respiratory system.

48. A method according to claim 44, wherein the sensor is a pressure transducer in pressure communication with the nasal mask.

49. A method according to claim 44, further comprising providing the signal to a sleep disorder clinical professional to assist in the diagnosis of obstructive sleep apnea.

50. A method according to claim 44, wherein the processing the signal provides at least one index useful in the diagnosis of obstructive sleep apnea.

51. A method according to claim 50, further comprising reviewing the at least one index to screen the patient for an indication of obstructive sleep apnea.

52. The method of claim 44 wherein the pre-apneic snoring pattern is decreasing snoring intensity.

53. A method according to claim 44, further comprising connecting the sensor to the nasal mask in sound communication.

54. A method according to claim 44, wherein the at least one respiratory parameter is the patient'"'"'s snoring or flow rate.

55. A method according to claim 44, further comprising recording and storing the signal over a period of time.

56. A method according to claim 44, further comprising:

comparing the at least one respiratory parameter with a predetermined respiratory parameter pattern; and

controlling pressure within the nasal mask based on the comparison between the at least one respiratory parameter and the predetermined respiratory parameter pattern.