Method and apparatus for adjusting desired pressure in positive airway pressure devices

• US 8,261,742 B2
• Filed: 08/25/2008
• Issued: 09/11/2012
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Invacare Corporation
• Original Assignee: Invacare Corporation
• Inventors: Strothmann, Thomas, Richey, Joseph B. II
• Primary Examiner(s): GINSBERG, OREN ISAAC
• Application Number:
  US12/197,692
• Publication Number:
  US 20090050154A1
• Time in Patent Office: 1,478 Days
• Field of Search: 128/204.18, 128/204.22, 128/204.23, 128/204.26, 128/205.11
• US Class Current: 128/204.23
• 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 16/026 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 16/161 with means for measuring the humidity
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0027 pressure meter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2230/06 Heartbeat rate only
• 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 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/42 Rate
• CPC Class Codes: A61M 2230/432 partial CO2 pressure (P-CO2)
• CPC Class Codes: A61M 2230/435 partial O2 pressure (P-O2)
• CPC Class Codes: A61M 2230/65 Impedance, e.g. conductivity, capacity

Abstract

Systems and methods for adjusting a desired pressure in a positive airway pressure (PAP) device are provided. In one embodiment, the method includes: a) providing breathing gas under positive pressure to a patient via a PAP device based on current desired pressure, b) monitoring a characteristic of the breathing gas, patient, or PAP device indicative of respiration, c) creating a breathing cycle signal having a first level associated with inhalation and a second level associated with exhalation, the signal being based on the monitored respiration characteristic, d) performing an abnormal breathing check based on the monitored respiration characteristic and the breathing cycle signal, and e) if abnormal breathing is detected, increasing the current desired pressure until a maximum desired pressure is reached, otherwise, decreasing the current desired pressure until a minimum desired pressure is reached. Several embodiments of an apparatus associated with the method are also provided.

Claims

1. A method for adjusting a desired pressure in a positive airway pressure device, the method comprising:

a) providing a breathing gas under positive pressure to a patient via a positive airway pressure device based at least in part on a current desired pressure;

b) monitoring a characteristic of the breathing gas that is indicative of respiration;

c) creating a breathing cycle signal with a first level associated with inhalation and a second level different from the first level and associated with exhalation, the breathing cycle signal being based at least in part on the monitored respiration characteristic;

d) performing one or more abnormal breathing checks based at least in part on the monitored respiration characteristic and the breathing cycle signal, wherein one or more abnormal breathing checks comprises a hypopnea check, the hypopnea check comprising;

creating a filtered respiration signal based at least in part on bandpass filtering the monitored respiration characteristic;

monitoring the breathing cycle signal;

clearing a positive surge counter and a negative surge counter each time the breathing cycle signal transitions from the second level to the first level to reset the hypopnea check at a start of each breathing cycle;

creating a triggered respiration signal with a first level associated with a positive surge and a second level different from the first level and associated with a negative surge, the triggered respiration signal being based at least in part on the filtered respiration signal;

monitoring the triggered respiration signal;

incrementing the positive surge counter each time the triggered respiration signal transitions from the second level to the first level to count a positive surge after an initial positive surge associated with inhalation;

incrementing the negative surge counter each time the triggered respiration signal transitions from the first level to the second level to count a negative surge;

reading the positive surge counter and the negative surge counter each time the breathing cycle signal transitions from the first level to the second level;

determining if the positive surge count is not equal to zero or the negative surge count is not equal to one; and

if either the positive surge count is not equal to zero or the negative surge count is not equal to one, abnormal breathing is detected based on the hypopnea check; and

e) if abnormal breathing is detected, increasing the current desired pressure by a first increment until a maximum desired pressure is reached, otherwise, decreasing the current desired pressure by a second increment until a minimum desired pressure is reached.

2. The method of claim 1, a) further comprising:

f) monitoring a characteristic of the breathing gas indicative of breathing gas pressure and

g) controlling a variable mechanism of the positive airway pressure device using a closed loop control process based at least in part on a difference between the current desired pressure and the monitored pressure characteristic to reduce the difference.

3. The method of claim 1 wherein the current desired pressure is based at least in part on a desired pressure profile.

4. The method of claim 3 wherein the desired pressure profile corresponds to a breathing cycle and comprises a first desired pressure associated with at least a portion of inhalation and a second desired pressure associated with at least a portion of exhalation, the second desired pressure being less than the first desired pressure.

5. The method of claim 3 wherein the desired pressure profile corresponds to a ramp period and comprises a first desired pressure associated with a time when the patient is presumed awake, a second desired pressure associated with a time when the patient is presumed asleep, and a ramp function to adjust the current desired pressure over the ramp period in relation to ramping from the first desired pressure to the second desired pressure, the first desired pressure being less than the second desired pressure.

6. The method of claim 1, c) further comprising:

f) detecting a start of inhalation based at least in part on a first transition of the monitored respiration characteristic in relation to a first predetermined threshold;

g) in response to detecting the start of inhalation, setting the breathing cycle signal to the first level;

h) detecting an end of inhalation based at least in part on a second transition of the monitored respiration characteristic in relation to a second predetermined threshold; and

i) in response to detecting the end of inhalation, setting the breathing cycle signal to the second level.

7. The method of claim 1 wherein at least one of the one or more abnormal breathing checks is based at least in part on the monitored respiration characteristic and the breathing cycle signal during a single breathing cycle.

8. The method of claim 1 wherein d) further comprises at least one selected from the group consisting of an apnea check, a persistent flow limitation check, a slow breathing check, and a fast breathing check.

9. The method of claim 1 wherein at least one of the one or more abnormal breathing checks is based at least in part on the monitored respiration characteristic and the breathing cycle signal during two consecutive breathing cycles.

10. The method of claim 1 wherein d) further comprises at least one selected from the group consisting of an irregular breathing cycle check and an irregular inhalation period check.

11. The method of claim 1 wherein d) further comprises at least one selected from the group consisting of an apnea check, an irregular breathing cycle check, an irregular inhalation period check, a persistent flow limitation check, a slow breathing check, and a fast breathing check.

12. The method of claim 1, d) further comprising an apnea check, the apnea check comprising:

f) monitoring the breathing cycle signal;

g) operating a free running counter having a count value that changes over time;

h) determining if the count value exceeds an apnea threshold;

i) if the count value exceeds the apnea threshold, abnormal breathing is detected based on the apnea check; and

j) resetting the count value of the free running counter each time the breathing cycle signal transitions from the second level to the first level.

13. The method of claim 1, d) further comprising an irregular breathing cycle check, the irregular breathing cycle check comprising:

f) monitoring the breathing cycle signal;

g) operating a system timer having a current timer value that changes over time;

h) latching the current timer value in a first storage location each time the breathing cycle signal transitions from the second level to the first level to identify a start time for a current breathing cycle;

i) determining a running breathing cycle time based at least in part on a difference between the start time and the current timer value;

j) latching the running breathing cycle time in a second storage location each time the breathing cycle signal transitions from the second level to the first level to store a current breathing cycle time;

k) latching the current breathing cycle time in a third storage location each time the breathing cycle signal transitions from the second level to the first level to store a previous breathing cycle time;

l) determining a variance between consecutive breathing cycle times based at least in part on a difference between the previous breathing cycle time and the current breathing cycle time;

m) determining if an absolute value of the variance exceeds an irregular breathing cycle threshold; and

n) if the absolute value exceeds the irregular breathing cycle threshold, abnormal breathing is detected based on the irregular breathing cycle check.

14. The method of claim 1, d) further comprising an irregular inhalation period check, the irregular inhalation period check comprising:

f) monitoring the breathing cycle signal;

g) operating a system timer having a current timer value that changes over time;

h) latching the current timer value in a first storage location each time the breathing cycle signal transitions from the second level to the first level to identify a start time for a current inhalation period;

i) determining a running inhalation period time based at least in part on a difference between the start time and the current timer value;

j) storing the running inhalation period time in a fourth storage location each time the breathing cycle signal transitions from the first level to the second level to store a current inhalation period time;

k) storing the current inhalation period time in a fifth storage location each time the breathing cycle signal transitions from the first level to the second level to store a previous inhalation period time;

l) determining a variance between consecutive inhalation period times based at least in part on a difference between the previous inhalation period time and the current inhalation period time;

m) determining if an absolute value of the variance exceeds an irregular inhalation period threshold; and

n) if the absolute value exceeds the irregular inhalation period threshold, abnormal breathing is detected based on the irregular inhalation period check.

15. The method of claim 1, d) further comprising a persistent flow limitation check, the persistent flow limitation check comprising:

f) monitoring the breathing cycle signal;

g) operating a system timer having a current timer value that changes over time;

h) storing the current timer value in a first storage location each time the breathing cycle signal transitions from the second level to the first level to identify a start time for a current breathing cycle and a current inhalation period time;

i) determining a running breathing cycle time based at least in part on a difference between the start time and the current timer value;

j) storing the running breathing cycle time in a second storage location each time the breathing cycle signal transitions from the second level to the first level to store a current breathing cycle time;

k) determining a running inhalation period time based at least in part on a difference between the start time and the current timer value;

l) storing the running inhalation period time in a fourth storage location each time the breathing cycle signal transitions from the first level to the second level to store a current inhalation period time;

m) determining a ratio of the current inhalation period time to the current breathing cycle time;

n) determining if the ratio exceeds an persistent flow limitation threshold; and

o) if the ratio exceeds the persistent flow limitation threshold, abnormal breathing is detected based on the persistent flow limitation check.

16. The method of claim 1, d) further comprising a slow breathing check, the slow breathing check comprising:

f) monitoring the breathing cycle signal;

g) operating a system timer having a current timer value that changes over time;

h) storing the current timer value in a first storage location each time the breathing cycle signal transitions from the second level to the first level to identify a start time for a current breathing cycle;

i) determining a running breathing cycle time based at least in part on a difference between the start time and the current timer value;

j) storing the running breathing cycle time in a second storage location each time the breathing cycle signal transitions from the second level to the first level to store a current breathing cycle time;

k) determining if the current breathing cycle time exceeds a maximum threshold; and

l) if the current breathing cycle time exceeds the maximum threshold, abnormal breathing is detected based on the slow breathing check.

17. The method of claim 1, d) further comprising a fast breathing check, the fast breathing check comprising:

f) monitoring the breathing cycle signal;

g) operating a system timer having a current timer value that changes over time;

h) storing the current timer value in a first storage location each time the breathing cycle signal transitions from the second level to the first level to identify a start time for a current breathing cycle;

i) determining a running breathing cycle time based at least in part on a difference between the start time and the current timer value;

j) storing the running breathing cycle time in a second storage location each time the breathing cycle signal transitions from the second level to the first level to store a current breathing cycle time;

k) determining if the current breathing cycle time is less than a minimum threshold; and

l) if the current breathing cycle time is less than the minimum threshold, abnormal breathing is detected based on the fast breathing check.

18. The method of claim 1, wherein the creating a triggered respiration signal further comprises:

detecting a positive surge based at least in part on a first transition of the filtered respiration signal in relation to a first predetermined threshold;

in response to detecting the positive surge, setting the triggered respiration signal to the first level;

detecting a negative surge based at least in part on a second transition of the filtered respiration signal in relation to a second predetermined threshold; and

in response to detecting the negative surge, setting the triggered respiration signal to the second level.

19. The method of claim 18 wherein the first and second levels of the triggered respiration signal correspond to voltage levels associated with opposing digital signal logic levels.

20. The method of claim 1 wherein each incremental increasing or decreasing in e) is associated with transition of the breathing cycle signal from the second level to the first level.

21. The method of claim 1, wherein the creating the breathing cycle signal comprises a Schmitt trigger to produce the breathing cycle signal.

22. The method of claim 1, wherein the creating the triggered respiration signal comprises a Schmitt trigger to produce the triggered respiration signal.

23. A method for adjusting a desired pressure in a positive airway pressure device, the method comprising:

a) providing a breathing gas under positive pressure to a patient via a positive airway pressure device based at least in part on a current desired pressure;

b) monitoring a characteristic of the breathing gas, a characteristic of the patient, or a characteristic of the positive airway pressure device that is indicative of respiration;

c) creating a breathing cycle signal having a first level associated with inhalation and a second level different from the first level and associated with exhalation, the breathing cycle signal being based at least in part on the monitored respiration characteristic;

d) performing an abnormal breathing check based at least in part on the monitored respiration characteristic and the breathing cycle signal, wherein performing the abnormal breathing check comprises;

creating a processed respiration signal based at least in part on the monitored respiration characteristic;

monitoring the breathing cycle signal;

creating a triggered respiration signal with a first level associated with a positive surge and a second level different from the first level and associated with a negative surge, the triggered respiration signal being based at least in part on the processed respiration signal;

monitoring the triggered respiration signal;

incrementing a peak counter each time the triggered respiration signal transitions from the second level to the first level;

reading the peak counter each time the breathing cycle signal transitions from the first level to the second level;

comparing the peak counter to a threshold level; and

based on the comparing, determining if abnormal breathing is detected; and

e) if abnormal breathing is detected, increasing the current desired pressure by a first increment until a maximum desired pressure is reached, otherwise, decreasing the current desired pressure by a second increment until a minimum desired pressure is reached.

24. The method of claim 23, a) further comprising:

f) monitoring a characteristic of the breathing gas indicative of breathing gas pressure;

g) controlling a variable mechanism of the positive airway pressure device using a closed loop control process based at least in part on a difference between the current desired pressure and the monitored pressure characteristic to reduce the difference;

h) determining if a runaway low pressure condition exists; and

i) if a runaway low pressure condition is detected, setting the current desired pressure to a desired startup pressure.

25. The method of claim 23, wherein the first and second levels of the triggered respiration signal correspond to voltage levels associated with opposing digital signal logic levels.

26. The method of claim 23, wherein the processed respiration signal is based at least in part on bandpass filtering the monitored respiration characteristic.

27. The method of claim 23, wherein the processed respiration signal is based at least in part on differentiating the monitored respiration characteristic.

28. The method of claim 23, wherein the creating the breathing cycle signal comprises a Schmitt trigger to produce the breathing cycle signal.

29. The method of claim 23, wherein the creating the triggered respiration signal comprises a Schmitt trigger to produce the triggered respiration signal.

30. An apparatus for adjusting a desired pressure in a positive airway pressure device, the apparatus comprising:

a breathing gas flow path in operative communication with a closed loop control logic, the breathing gas flow path and closed loop control logic being adapted to provide a breathing gas under positive pressure to a patient based at least in part on a current desired pressure;

a respiration characteristic monitoring logic in operative communication with the breathing gas flow path to monitor a characteristic of the breathing gas, a characteristic of the patient, or a characteristic of the apparatus that is indicative of respiration;

a breathing cycle signal logic in operative communication with the respiration characteristic monitoring logic to create a breathing cycle signal having a first level associated with inhalation and a second level different from the first level and associated with exhalation, the breathing cycle signal being based at least in part on the monitored respiration characteristic;

an abnormal breathing check logic in operative communication with at least one of the breathing cycle signal logic and the respiration characteristic monitoring logic to perform an abnormal breathing check based at least in part on the monitored respiration characteristic and the breathing cycle signal, wherein the abnormal breathing check logic comprises;

logic for creating a processed respiration signal based at least in part on the monitored respiration characteristic;

logic for monitoring the breathing cycle signal;

logic for creating a triggered respiration signal with a first level associated with a positive surge and a second level different from the first level and associated with a negative surge, the triggered respiration signal being based at least in part on the processed respiration signal;

logic for monitoring the triggered respiration signal;

logic for incrementing a first counter based on a transition of the triggered respiration signal from the second level to the first level to count a rising edge;

logic for incrementing a second counter based on a transition of the triggered respiration signal from the first level to the second level to count a falling edge;

logic for reading the first counter and the second counter each time the breathing cycle signal transitions from the first level to the second level;

logic for comparing the first counter and second counter to one or more threshold levels; and

based on the comparing, logic for determining if abnormal breathing is detected; and

a desired pressure adjustment logic in operative communication with the abnormal breathing check logic, breathing cycle signal logic, and closed loop control logic to increase the current desired pressure by a first increment until a maximum desired pressure is reached, if abnormal breathing is detected and to decrease the current desired pressure by a second increment until a minimum desired pressure is reached if abnormal breathing is not detected.

31. The apparatus of claim 30, wherein the first and second levels of the triggered respiration signal correspond to voltage levels associated with opposing digital signal logic levels.

32. The apparatus of claim 30, wherein the logic for creating a processed respiration signal comprises a bandpass filter.

33. The apparatus of claim 30, wherein the logic for creating a processed respiration signal comprises a differentiator.

34. The apparatus of claim 30, wherein the logic for incrementing the first counter comprises logic for incrementing during each transition of the triggered respiration signal from the second level to the first level.

35. The apparatus of claim 30, wherein the breathing cycle signal logic comprises a Schmitt trigger to create the breathing cycle signal.

36. The apparatus of claim 30, wherein the abnormal breathing check logic comprises a Schmitt trigger to create the triggered respiration signal.

37. A method for adjusting a desired pressure in a positive airway pressure device, the method comprising:

a) providing a breathing gas under positive pressure to a patient via a positive airway pressure device based at least in part on a current desired pressure;

b) monitoring a characteristic of the breathing gas that is indicative of respiration;

c) creating a breathing cycle signal with a first level associated with inhalation and a second level different from the first level and associated with exhalation, the breathing cycle signal being based at least in part on the monitored respiration characteristic;

d) performing one or more abnormal breathing checks based at least in part on the monitored respiration characteristic and the breathing cycle signal, wherein one or more abnormal breathing checks comprises a hypopnea check, the hypopnea check comprising;

creating a processed respiration signal based at least in part on the monitored respiration characteristic;

monitoring the breathing cycle signal;

creating a triggered respiration signal with a first level associated with a positive surge and a second level different from the first level and associated with a negative surge, the triggered respiration signal being based at least in part on the processed respiration signal;

monitoring the triggered respiration signal;

incrementing a first counter based on a transition of the triggered respiration signal from the second level to the first level to count a rising edge;

incrementing a second counter based on a transition of the triggered respiration signal from the first level to the second level to count a falling edge;

reading the first counter and the second counter each time the breathing cycle signal transitions from the first level to the second level;

comparing the first counter and second counter to one or more threshold levels; and

based on the comparing, determining if abnormal breathing is detected based on the hypopnea check; and

e) if abnormal breathing is detected, increasing the current desired pressure by a first increment until a maximum desired pressure is reached, otherwise, decreasing the current desired pressure by a second increment until a minimum desired pressure is reached.

38. The method of claim 37 wherein the first and second levels of the triggered respiration signal correspond to voltage levels associated with opposing digital signal logic levels.

39. The method of claim 37, wherein the processed respiration signal is based at least in part on bandpass filtering the monitored respiration characteristic.

40. The method of claim 37, wherein the processed respiration signal is based at least in part on differentiating the monitored respiration characteristic.

41. The method of claim 37, wherein the first counter is incremented during each transition of the triggered respiration signal from the second level to the first level.

42. The method of claim 37, wherein the creating the breathing cycle signal comprises a Schmitt trigger to produce the breathing cycle signal.

43. The method of claim 37, wherein the creating the triggered respiration signal comprises a Schmitt trigger to produce the triggered respiration signal.