Patient-ventilator synchronization using dual phase sensors

• US 6,910,480 B1
• Filed: 09/14/2000
• Issued: 06/28/2005
• Est. Priority Date: 09/15/1999
• Status: Expired due to Term

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Berthon-Jones, Michael
• Primary Examiner(s): Bennett, Henry
• Assistant Examiner(s): WIEKER, AMANDA FLYNN
• Application Number:
  US09/661,998
• Time in Patent Office: 1,748 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23
• US Class Current: 128/204.21
• CPC Class Codes: A61M 16/00 Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes stimulating the respiratory movement by mechanical, pneumatic or electrical means, iron lungs combined with gas breathing means A61H31/00
• CPC Class Codes: A61M 16/0066 Blowers or centrifugal pumps
• 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 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user

Abstract

An improved ventilator which delivers ventilatory support that is synchronized with the phase of the patient'"'"'s respiratory efforts and guarantees a targeted minimum ventilation. Improved synchronization is achieved through an instantaneous respiratory phase determination process based upon measured respiratory airflow as well as measured respiratory effort using an effort sensor accessory, preferably a suprasternal notch sensor. The ventilator processes a respiratory airflow signal, a respiratory effort signal and their respective rates of change to determine a phase using standard fuzzy logic methods. A calculated pressure amplitude is adjusted based upon the calculated phase and a smooth pressure waveform template to deliver synchronized ventilation.

Claims

1. A method of providing synchronized ventilatory support to a patient comprising the steps of:

providing an apparatus to deliver ventilatory support to a patient, the apparatus comprising an airflow sensor and a respiratory effort sensor;

determining at least one instantaneous phase of respiration of the patient continuously at least during inspiration at least in part from both measured respiratory airflow and a signal from a respiratory effort sensor;

calculating a desired pressure value using the determined phase and a desired ventilation pressure amplitude; and

delivering ventilation to said patient in accordance with said desired pressure value.

2. The method of claim 1 further comprising the step of positioning the effort sensor to sense patient effort external to the patient-ventilator airway apparatus in a manner that is independent from a leak in the patient-ventilator airway apparatus.

3. The method of claim 2 wherein said respiratory effort sensor is selected from a group of effort sensors that are independent of a leak in an airflow that may affect respiratory airflow measurement including:

(a) a suprasternal notch sensor;

(b) an esophageal pressure effort sensor, and

(c) an electromyograph.

4. The method of claim 3 wherein the instantaneous phase is a fraction of a revolution of a respiration cycle.

5. The method of claim 4 wherein the phase determining step comprises evaluating fuzzy inference rules relating to said signal from said respiratory effort sensor.

6. The method of claim 5 wherein said phase determining step further comprises evaluating fuzzy inference rules relating to the rate of change of said signal from said respiratory effort sensor.

7. The method of claim 6 wherein said fuzzy inference rules include at least one rule selected from a group of rules including:

(a) If the effort signal is zero and increasing fast, then phase is about 0 revolutions;

(b) If the effort signal is medium and increasing moderately, then phase is about 0.2 revolutions;

(c) If the effort signal is large and decreasing fast, then phase is about 0.5 revolutions; and

(d) If the effort signal is medium and decreasing moderately, then phase is about 0.7 revolutions.

8. The method of claim 6 wherein said fuzzy inference rules include a rule in which the start of inspiration is associated with approximately zero respiratory effort which is increasing fast.

9. The method of claim 6 wherein said fuzzy inference rules include a rule in which mid-inspiration is associated with medium respiratory effort which is increasing moderately.

10. The method of claim 6 wherein said fuzzy inference rules include a rule in which the beginning of expiration is associated with large respiratory effort which is decreasing fast.

11. The method of claim 6 wherein said fuzzy inference rules include a rule in which mid-expiration is associated with medium respiratory effort which is decreasing moderately.

12. The method of claim 6 wherein said phase determining step further includes the sub-step of evaluating fuzzy logic inference rules relating to the measured respiratory airflow.

13. The method of claim 12 wherein said phase determining step further includes the sub-step of evaluating fuzzy logic inference rules relating to the rate of change of the measured respiratory airflow.

14. The method of claim 13 wherein said fuzzy inference rules include at least one rule selected from a group of rules including:

(a) If the airflow is zero and increasing fast, then phase is about 0 revolutions;

(b) If the airflow is large positive and steady, then phase is about 0.25 revolutions;

(c) If the airflow is zero and falling fast, then phase is about 0.5 revolutions;

(d) If the airflow is large negative and steady, then phase is about 0.75 revolutions;

(e) If the airflow is zero and steady and the 5-second low-pass filtered absolute value of the respiratory airflow is large, then phase is about 0.9 revolutions;

(f) If the airflow is positive and the phase is expiratory, then phase is about 0.1 revolutions;

(g) If the airflow is negative and the phase is inspiratory, then phase is about 0.6 revolutions;

(h) If the 5-second low-pass filtered absolute value of the respiratory airflow is small, then phase in the respiratory cycle is increasing at a fixed rate equal to the patient'"'"'s expected respiratory rate; and

(i) If the 5-second low-pass filtered absolute value of the respiratory airflow is large, then the phase in the respiratory cycle is increasing at a steady rate equal to the existing rate of change of phase, low-pass filtered with a time constant of 20 seconds.

15. The method of claim 1 wherein said phase determining step further includes the sub-step of evaluating fuzzy logic inference rules relating to the measured respiratory airflow.

16. The method of claim 15 wherein said phase determining step further includes the sub-step of evaluating fuzzy logic inference rules relating to the rate of change of the measured respiratory airflow.

17. The method of claim 1 wherein the desired ventilation pressure amplitude is varied between a non-zero minimum value and a maximum value.

18. The method of claim 17 wherein said step of calculating a desired pressure value includes deriving an error value that is a function of the difference between calculated patient ventilation and a target value.

19. The method of claim 3 wherein the apparatus to deliver ventilatory support to a patient includes a mask.

20. An apparatus for providing synchronized ventilatory support to a patient comprising:

at least one sensor to generate a respiratory effort signal;

at least one sensor to generate a respiratory airflow signal;

a processor in communication with the effort signal, and the airflow signal configured for analyzing both the respiratory airflow signal and the effort signal and to determine at least one instantaneous phase of a respiratory cycle of the patient continuously at least during inspiration and to generate a pressure request signal as a function of said instantaneous respiratory phase and a ventilation pressure amplitude; and

a servo-controlled blower to provide pressurized air to said patient in accordance with said pressure request signal.

21. The apparatus of claim 20 wherein the instantaneous phase is a fraction of a revolution of a respiratory cycle.

22. The apparatus of claim 21 wherein said at least one sensor is an effort sensor from a group of effort sensors that are independent of a leak in airflow that may affect respiratory airflow measurement including:

(a) a suprasternal notch sensor;

(b) an esophageal pressure effort sensor; and

(c) an electromyograph.

23. The apparatus of claim 22 wherein said processor is further configured to control an evaluation of fuzzy inference rules relating to the rate of change of said respiratory effort signal.

24. The apparatus of claim 23 wherein said fuzzy inference rules include at least one rule selected from a group of rules including:

(a) If the effort signal is zero and increasing fast, then phase is about 0 revolutions;

(b) If the effort signal is medium and increasing moderately, then phase is about 0.2 revolutions;

(c) If the effort signal is large and decreasing fast, then phase is about 0.5 revolutions; and

(d) If the effort signal is medium and decreasing moderately, then phase is about 0.7 revolutions.

25. The apparatus of claim 23 wherein said fuzzy inference rules include a rule in which the start of inspiration is associated with approximately zero respiratory effort which is increasing fast.

26. The apparatus of claim 23 wherein said fuzzy inference rules include a rule in which mid-inspiration is associated with medium respiratory effort which is increasing moderately.

27. The apparatus of claim 23 wherein said fuzzy inference rules include a rule in which the beginning of expiration is associated with large respiratory effort which is decreasing fast.

28. The apparatus of claim 23 wherein said fuzzy inference rules include a rule in which mid-expiration is associated with medium respiratory effort which is decreasing moderately.

29. The apparatus of claim 23 wherein said processor is further configured to control an evaluation of fuzzy logic inference rules relating to the respiratory airflow.

30. The apparatus of claim 29 wherein said processor is further configured to control an evaluation of fuzzy logic inference rules relating to the rate of change of the respiratory airflow.

31. The apparatus of claim 30 wherein said fuzzy inference rules include at least one rule selected form a group of rules including:

a) If the airflow is zero and increasing fast, then phase is about 0 revolutions;

(b) If the airflow is large positive and steady, then phase is about 0.25 revolutions;

(c) If the airflow is zero and falling fast, then phase is about 0.5 revolutions;

(d) If the airflow is large negative and steady, then phase is about 0.75 revolutions;

(e) If the airflow is zero and steady and the 5-second low-pass filtered absolute value of the respiratory airflow is large, then phase is about 0.9 revolutions;

(f) If the airflow is positive and the phase is expiratory, then phase is about 0.1 revolutions;

(g) If the airflow is negative and the phase is inspiratory, then phase is about 0.6 revolutions;

(h) If the 5-second low-pass filtered absolute value of the respiratory airflow is small, then phase in the respiratory cycle is increasing at a fixed rate equal to the patient'"'"'s expected respiratory rate; and

(i) If the 5-second low-pass filtered absolute value of the respiratory airflow is large, then phase in the respiratory cycle is increasing at a steady rate equal to the existing rate of change of phase, low-pass filtered with a time constant of 20 seconds.

32. The apparatus of claim 20 wherein said processor is configured to control an evaluation of fuzzy inference rules relating to said respiratory effort signal.

33. The apparatus of claim 20 wherein said processor is further configured to control an evaluation of fuzzy logic inference rules relating to the respiratory airflow.

34. The apparatus of claim 33 wherein said processor is further configured to control an evaluation of fuzzy logic inference rules relating to the rate of change of the respiratory airflow.

35. The apparatus of claim 20 wherein the ventilation pressure amplitude is varied between a non-zero minimum value and a maximum value.

36. The apparatus of claim 35 wherein the generation of said pressure request signal includes deriving an error value that is a function of the difference between calculated patient ventilation and a target value.

37. The apparatus of claim 20 further comprising a mask and conduit through which said pressurized air is delivered to the patient.

38. A method of providing synchronized ventilatory support to a patient comprising the steps of:

providing an apparatus for ventilatory support to a patient comprising a flow sensor and a respiratory effort sensor;

determining at least one instantaneous phase of respiration of the patient continuously at least during inspiration, said instantaneous phase being represented as a fraction of a revolution of a respiratory cycle at least in part from a signal from the respiratory effort sensor and a signal from the flow sensor;

calculating a pressure value using the determined phase and a ventilation pressure amplitude;

and delivering ventilation to said patient in accordance with said pressure value.

39. The method of claim 38 further comprising the step of locating the respiratory effort sensor to detect respiratory effort in a manner that renders an effort signal from the respiratory effort sensor independent of leak in the patient-ventilator airway circuit of the apparatus for ventilatory support.

40. The method of claim 39 wherein said respiratory effort sensor is selected from a group of effort sensors that are independent of a leak in airflow that may affect respiratory airflow measurement including:

(a) a suprasternal notch sensor;

(b) an esophageal pressure effort sensor; and

(c) an electromyograph.

41. The method of claim 40 wherein said phase determining step comprises evaluating fuzzy inference rules relating to said signal from said respiratory effort sensor.

42. The method of claim 41 wherein said phase determining step further comprises evaluating fuzzy logic inference rules relating to the rate of change of said signal from said respiratory effort sensor.

43. The method of claim 38 wherein the apparatus for ventilatory support further comprising a mask.

44. An apparatus for providing synchronized ventilatory support to a patient comprising:

at least one sensor to generate a respiratory effort signal;

at least one sensor to generate a respiratory airflow signal;

a processor in communication with the effort signal and airflow signal configured for analyzing both said effort signal and said airflow signal and to determine an instantaneous phase of a respiratory cycle of the patient continuously at least during inspiration represented as a fraction of a revolution of a respiratory cycle and to generate a desired pressure request signal as a function of said instantaneous respiratory phase and a desired ventilation pressure value; and

a servo-controlled blower to provide pressurized air to said patient in accordance with said pressure request signal.

45. The apparatus of claim 44 wherein said at least one sensor is an effort sensor from a group of effort sensors that are independent of a leak in airflow that may affect respiratory airflow measurement including:

a) a suprasternal notch sensor;

(b) an esophageal pressure effort sensor; and

(c) an electromyograph.

46. The apparatus of claim 45 wherein said processor is further configured to control an evaluation of fuzzy inference rules relating to said respiratory effort signal.

47. The apparatus of claim 46 wherein said processor is further configured to control an evaluation of fuzzy inference rules relating to the rate of change of said respiratory effort signal.

48. The apparatus of claim 44 further comprising a mask and conduit through which said pressurized air is delivered to a patient.

49. A method of providing synchronized ventilatory support to a patient comprising the steps of:

providing an apparatus to deliver ventilatory support to a patient, the apparatus comprising an airflow sensor and a respiratory effort sensor;

determining an instantaneous phase of respiration of the patient continuously during inspiration and expiration cycles of the patient at least in part from both measured respiratory airflow and a signal from a respiratory effort sensor, calculating a desired pressure value with the determined phase value and a desired ventilation pressure amplitude; and

delivering ventilation to said patent in accordance with said desired pressure value during the patien'"'"'s inspiration and expiration cycles.