Apparatus and method for controlling the administration of CPAP treatment

• US 6,363,933 B1
• Filed: 12/16/1999
• Issued: 04/02/2002
• Est. Priority Date: 11/05/1993
• Status: Expired due to Term

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Berthon-Jones, Michael
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/464,584
• Time in Patent Office: 838 Days
• Field of Search: 128/204.23, 128/204.21, 128/204.24, 128/204.18, 128/716, 128/671, 128/672, 128/204.26, 128/200.24, 128/203.12, 128/207.14, 128/205.23
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/7257 using Fourier transforms
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A61M 16/0006 with means for creating vibrations in patients' airways
• 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 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: Y02A 90/10 Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

Methods and apparatus for determining the occurrence of an apnea, patency and/or partial obstruction of the airway are disclosed. Respiratory air flow from a patient is measured to give an air flow signal. The determination of an apnea is performed by calculating the variance of the air flow signal over a moving time window and comparing the variance with a threshold value. One determination of partial obstruction of the airway is performed by detecting the inspiratory part of the air flow signal, scaling it to unity duration and area and calculating an index value of the amplitude of the scaled signal over a mid-portion. Alternatively, the index value is a measure of the flatness of the air flow signal over the mid-portion. One determination of patency of the airway is performed by applying an oscillatory pressure waveform of known frequency to a patient'"'"'s airway, calculating the magnitude of the component of said air flow signal at the known frequency induced by the oscillatory pressure waveform and comparing the calculated magnitude with a threshold value. Alternatively, the air flow signal is analysed to detect the presence of a component due to cardiogenic activity.

Claims

1. A method for determining an occurrence of an apnea in a patient, the method comprising the steps of:

measuring respiratory air flow from a patient as a function of time;

determining a variance of said measured air flow; and

determining from said variance that an apnea is occurring.

2. A method as claimed in claim 1, wherein said variance is a moving average over a time window.

3. A method as claimed in claim 2, comprising the further step of comparing said variance with a threshold value, and if said variance falls below said threshold value then an apnea is occurring.

4. A method as claimed in claim 3, wherein said measured air flow is expressed as an air flow signal.

5. A method as claimed in claim 4, wherein said step of measuring includes sampling said respiratory air flow at equally spaced points in time to give a sampled air flow signal.

6. A method as claimed in claim 3, wherein, in said comparing step, said variance must fall below said threshold value for a predetermined period of time before it is determined that an apnea is occurring.

7. A method as claimed in claim 3, comprising the further step of either commencing continuous positive airway pressure (CPAP) treatment or increasing CPAP treatment pressure to the patient if an apnea is occurring.

8. A method for controlling the administration of CPAP treatment to the airway of a patient by means controllable to supply breathable air to the patient'"'"'s airway continually at a selectable pressure elevated above atmospheric pressure, the method comprising the steps of:

determining a presence or absence of an apnea, and

(a) if an apnea is occurring then;

determining whether the airway is patent, and if not patent then increasing the CPAP treatment pressure;

else

(b) if an apnea is not occurring then;

determining a presence and a magnitude of partial obstruction, and if there is partial obstruction then increasing the CPAP treatment pressure as a function of the magnitude of the partial obstruction, else if there is no partial obstruction, reducing the CPAP treatment pressure.

9. The method of claim 8, whereby the presence of partial obstruction is determined by a presence of snoring or flow limitation, or both.

10. The method of claim 9, whereby the presence of flow limitation is determined by the steps of:

measuring respiratory air flow from the patient;

detecting an inspiratory part of said air flow; and

determining an index value of a mid-portion of said inspiratory part as a measure of partial obstruction.

11. The method of claim 10, whereby said mid-portion is a middle half of said inspiratory part.

12. The method of claim 10, whereby said index value is determined from an amplitude of said mid-portion of said inspiratory part.

13. The method of claim 12, whereby said index value is determined as an arithmetic mean value of said amplitude in said mid-portion.

14. The method of claim 12, whereby said index value is determined from a flatness of said mid-portion of said inspiratory part.

15. The method of claim 14, whereby said index value is determined as a root mean square (RMS) deviation of said inspiratory part in said mid-portion with respect to unity.

16. The method of claim 14, wherein said index value is a ratio of a mean of said mid-portion of said inspiratory part to a mean of said inspiratory part.

17. The method of claim 8, whereby the magnitude of the pressure increase is a decreasing function of an existing treatment pressure.

18. The method of claim 8, whereby the magnitude of the pressure increase is a decreasing function of the extent of mask or mouth leak.

19. The method of claim 8, whereby the pressure increase in response to an apnea is performed at the end of the apnea.

20. Apparatus for controlling administration of CPAP treatment to the airway of a patient comprising:

air supply means controllable to supply breathable air to a patient'"'"'s airway continually at a selectable pressure elevated above atmospheric pressure; and

controlling means, coupled to the air supply means, operable to cause a change in the CPAP treatment, pressure by determining the presence or absence of an apnea, and

(a) if an apnea is occurring then;

determining whether the airway is patent, and if not patent then causing an increase in the CPAP treatment pressure;

else

(b) if an apnea is not occurring then;

determining a presence and a magnitude of partial obstruction, and if there is partial obstruction then causing an increase in the CPAP treatment pressure as a function of the magnitude of the partial obstruction, else if there is no partial obstruction, causing a reduction in the CPAP treatment pressure.

21. The apparatus of claim 20, further comprising sensor means for determining a presence of snoring or flow limitation in the patient'"'"'s respiration, and wherein the controlling means determines a presence of partial obstruction from the presence of snoring or flow limitation, or both.

22. The apparatus of claim 21, wherein the sensor means measures respiratory air flow from the patient, and wherein the controlling means is operable to detect an inspiratory part of the airflow, and determine an index value of a mid-portion of the inspiratory part as a measure of partial obstruction.

23. The apparatus of claim 22, wherein the controlling means determines the mid-portion to be the middle half of the inspiratory part.

24. The apparatus of claim 22, wherein the controlling means determines the index value from an amplitude of the mid-portion of the inspiratory part.

25. The apparatus of claim 24, wherein the controlling means determines the index value as an arithmetic mean value of the amplitude in the mid-portion.

26. The apparatus of claim 24, wherein the controlling means determines the index value from a flatness of the mid-portion of the inspiratory part.

27. The apparatus of claim 26, wherein the controlling means determines the index value as a root mean square (RMS) deviation of the inspiratory part in the mid-portion with respect to unity.

28. The apparatus of claim 26, wherein said index value is a ratio of a mean of said mid-portion of said inspiratory part to a mean of said inspiratory part.

29. The apparatus of claim 20, wherein the pressure increase caused by the controlling means is a decreasing function of an existing treatment pressure.

30. The apparatus of claim 20, wherein the pressure increase caused by the controlling means is a decreasing function of mask or mouth leak.

31. The apparatus of claim 20, wherein the pressure increase caused by the controlling means, in response to an apnea, is performed at the end of the apnea.

32. A method for controlling the administration of CPAP treatment to the airway of a patient by controlling the supply of breathable air at a selectable pressure elevated above atmospheric pressure, the method comprising the step of commencing or increasing CPAP treatment pressure to a patient when an apnea is detected only if the patient'"'"'s airway is not patent, wherein said airway is determined to be patent by:

applying an oscillatory pressure waveform of known frequency to the patient'"'"'s airway;

measuring respiratory air flow from the patient; and

determining if the airway is patent by detecting a component of said air flow at said known frequency induced by said oscillatory pressure waveform.

33. The method of claim 32 further comprising the step of commencing or increasing CPAP treatment pressure if there is partial obstruction of the airway determined by:

measuring respiratory air flow of the patient over time; and

determining the variance of said air flow as an indication that an apnea is occurring.

34. The method of claim 33 further comprising the step of commencing or increasing CPAP treatment pressure if there is partial obstruction of the airway determined by the steps of:

measuring respiratory air flow from the patient;

detecting the inspiratory part of said air flow; and

determining an index value of a mid-portion of said inspiratory part as a measure of partial obstruction.

35. The method of claim 34 further comprising the step of reducing CPAP treatment pressure if:

(a) there is no apnea occurring and there is no partial obstruction;

or

(b) there is an apnea occurring but the airway is patent.

36. A method for controlling the administration of CPAP treatment to the airway of a patient by controlling the supply of breathable air at a selectable pressure elevated above atmospheric pressure, the method comprising the step of commencing or increasing CPAP treatment pressure to a patient when an apnea is detected only if the patient'"'"'s airway is not patent, wherein said airway is determined to be patent by:

measuring respiratory air flow from the patient; and

determining if the airway is patent by detecting a presence of cardiogenic air flow from said respiratory air flow.

37. The method of claim 36 further comprising the step of commencing or increasing CPAP treatment pressure if there is partial obstruction of the airway determined by:

measuring respiratory air flow of the patient over time; and

determining the variance of said air flow as an indication that an apnea is occurring.

38. The method of claim 37 further comprising the step of commencing or increasing CPAP treatment pressure if there is partial obstruction of the airway determined by the steps of:

measuring respiratory air flow from the patient;

detecting the inspiratory part of said air flow; and

determining an index value of a mid-portion of said inspiratory part as a measure of partial obstruction.

39. The method of claim 38 further comprising the step of reducing CPAP treatment pressure if:

(a) there is no apnea occurring and there is no partial obstruction;

or

(b) there is an apnea occurring and the airway is patent.

40. Apparatus for control of the administration of CPAP treatment to the airways of a patient, the apparatus comprising:

a mask for the provision of breathable gas to a patient'"'"'s airways;

a conduit connected with said mask;

a controllable flow generator to supply said breathable gas to said conduit at a controlled pressure elevated above atmospheric pressure;

a pressure transducer responsive to the patient'"'"'s respiration to output a signal representative of respiratory airflow; and

a processor to process said airflow signal and to control said flow generator wherein said processor;

calculates a variance of said airflow signal;

increases the controlled pressure if a comparison between said variance with a threshold indicates an apnea is occurring.

41. The apparatus of claim 40, wherein said processor increases the controlled pressure if said comparison indicates that said variance is less than said threshold value.

42. The apparatus of claim 41, wherein said variance is a moving average over a time window.

43. The apparatus of claim 42, wherein said processor samples said respiratory air flow signal at equally spaced points in time to derive said variance from said air flow signal.

44. A method for detecting partial obstruction of the airway of a patient, the method comprising the steps of:

measuring patient respiratory airflow over time;

determining air flow values from the measure of respiratory air flow during the course of a breath;

identifying inspiratory values from said air flow values; and

determining a measure of partial obstruction which is a ratio of a mean of a mid-portion of said inspiratory values to a mean of said inspiratory values.

45. The method of claim 44 further comprising the step of determining a second measure of partial obstruction as the ratio of a root mean square deviation of a mid-portion of the inspiratory values to a mean of said inspiratory values.

46. The method of claim 45 further comprising the step of scaling said inspiratory values so that the inspiratory values represent an inspiratory flow versus time curve having unit duration and unit area.

47. The method of claim 46 further comprising the step of rejecting inspiratory values deviating by more than a threshold value.

48. The method of claim 45 further comprising comparing said measure to a threshold value and said second measure to a threshold value.

49. The method of claim 48 further comprising determining the existence of partial obstruction if either of said measure or said second measure is less than its compared to threshold.

50. The method of claim 49 further comprising determining the absence of partial obstruction if neither of said measure or said second measure is less than its compared to threshold.

51. The method of claim 49 further comprising either commencing continuous positive airway pressure (CPAP) treatment or increasing CPAP treatment to the patient if the existence of partial obstruction is determined.

52. Apparatus for detecting partial obstruction of the airway of a patient comprising:

sensor means responsive to a patient'"'"'s respiration to output a signal representative of respiratory airflow; and

processor means, coupled to the sensor means, to receive said signal, wherein said processor means;

determines air flow values from said signal during the course of a breath;

identifies inspiratory values from said air flow values; and

determines a measure of partial obstruction which is a ratio of a mean of a mid-portion of said inspiratory values to a mean of said inspiratory values.

53. The apparatus of claim 52 further comprising:

air supply means controllable to supply breathable air to the patient'"'"'s airway continually at a selectable pressure elevated above atmospheric pressure,

wherein said processor means causes said air supply means to commence or increase continuous positive airway pressure when said measure of partial obstruction is less than a threshold.

54. An apparatus for detecting partial obstruction of the airway of a patient comprising:

a pressure transducer responsive to the patient'"'"'s respiration to output a signal representative of respiratory airflow; and

a processor to process said airflow signal and wherein said processor;

determines air flow values from said signal during the course of a breath;

identifies inspiratory values from said air flow values; and

determines a measure of partial obstruction which is a ratio of a mean of a mid-portion of said inspiratory values to a mean of said inspiratory values.

55. The apparatus of claim 54 further comprising:

a mask for the provision of breathable gas to a patient'"'"'s airways;

a conduit connected with said mask; and

a controllable flow generator to supply said breathable gas to said conduit at a controlled pressure elevated above atmospheric pressure,

wherein said processor causes said air supply means to commence or increase continuous positive airway pressure when said measure of partial obstruction is less than a threshold.

56. A method for determining a degree of obstruction of the airway of a patient receiving continuous positive airway pressure (CPAP) treatment by apparatus for supplying CPAP to the patient'"'"'s airway, the method comprising the steps of:

measuring respiratory air flow from a patient to give an air flow signal which may include a snore component;

predicting an expected flow signal; and

subtracting said expected flow signal from said air flow signal to yield a snore component signal as a measure of a degree of obstruction of the airway.

57. The method of claim 56 further comprising the step of commencing or increasing CPAP treatment based upon said measure of a degree of obstruction of the airway.

58. The method of claim 57 wherein said step of commencing or increasing CPAP treatment involves a comparison between said measure of a degree of obstruction and a threshold value.

59. The method of claim 58 wherein said expected flow signal is a function of blower speed and airflow.

60. An apparatus for detecting partial obstruction of the airway of a patient comprising:

a mask for the provision of breathable gas to a patient'"'"'s airways;

a conduit connected with said mask;

a controllable flow generator to supply said breathable gas to said conduit at a controlled pressure elevated above atmospheric pressure;

a pressure transducer in sound communication with the patient'"'"'s respiratory system to generate a flow signal;

a tachometer for said flow generator to give a speed signal; and

a processor to process said flow signal from said transducer and said speed signal from said tachometer and to control said flow generator, wherein said processor;

predicts an expected flow using said flow signal and said speed signal; and

subtracts said expected flow from said flow signal to yield a snore signal as a measure of a degree of obstruction of the airway.

61. The apparatus of claim 60 wherein said processor commences or increases continuous positive airway pressure treatment based upon a comparison between said measure of a degree of obstruction of the airway and a threshold value.

62. An apparatus for detecting partial obstruction of the airway of a patient comprising:

air supply means controllable to supply breathable air to a patient'"'"'s airway continually at a selectable pressure elevated above atmospheric pressure;

a flow sensor means to generate a flow signal representative of respiratory airflow and patient snoring;

a speed sensor means for said air supply means; and

a processor means to process a flow signal from said flow sensor and a speed signal from said speed sensor and to control said air supply means, wherein said processor;

predicts an expected flow using said flow signal and said speed signal; and

subtracts said expected flow from said flow signal to yield a snore signal as a measure of a degree of obstruction of the airway.

63. The apparatus of claim 62 wherein said processor commences or increases continuous positive airway pressure treatment based upon a comparison between said measure of a degree of obstruction of the airway and a threshold value.