Ventilatory assistance for treatment of cardiac failure and cheyne-stokes breathing

• US 6,532,959 B1
• Filed: 05/21/1999
• Issued: 03/18/2003
• Est. Priority Date: 05/22/1998
• 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): Lewis, Aaron J.
• Assistant Examiner(s): MITCHELL, TEENA KAY
• Application Number:
  US09/316,432
• Time in Patent Office: 1,397 Days
• Field of Search: 128/204.23, 128/204.21, 128/204.18, 128/204.24, 128/204.22, 128/204.26, 128/204.29, 128/205.11, 600/529
• US Class Current: 128/204.23
• 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 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/0051 with alarm devices
• CPC Class Codes: A61M 16/0057 Pumps therefor
• 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 16/0858 Pressure sampling ports
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2230/42 Rate

Abstract

Method and apparatus for the treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea are disclosed. A subject is provided with ventilatory support, for example positive pressure ventilatory support using a blower and mask. Respiratory airflow is determined. From the respiratory airflow are derived a measure of instantaneous ventilation (for example half the absolute value of the respiratory airflow) and a measure of longterm average ventilation (for example the instantaneous ventilation low pass filtered with a 100 second time constant). A target ventilation is taken as 95% of the longterm average ventilation. The instantaneous ventilation is fed as the input signal to a clipped integral controller, with the target ventilation as the reference signal. The output of the controller determines the degree of ventilatory support. Clipping is typically to between half and double the degree of support that would do all the respiratory work. A third measure of ventilation, for example instantaneous ventilation low pass filtered with a time constant of 5 seconds, is calculated. Ventilatory support is in phase with the subject'"'"'s respiratory airflow to the fuzzy extent that this ventilation is above target, and at a preset rate conversely.

Claims

1. A method for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of:

providing a subject with ventilatory support;

deriving a measure of the subject'"'"'s instantaneous ventilation; and

adjusting a degree of ventilatory support to reduce changes in said measure of instantaneous ventilation over a time scale similar to that of a waxing-waning cycle of untreated Cheyne-Stokes breathing or central sleep apnea, while allowing changes in said measure of instantaneous ventilation over a time scale much longer than said waxing-waning cycle.

2. A method as claimed in claim 1, wherein the step of adjusting the degree of ventilatory support comprises the steps of:

low pass filtering said measure of instantaneous ventilation to derive a measure of longterm average ventilation;

setting a target signal equal to a fraction of said measure of longterm average ventilation; and

servo-controlling said measure of instantaneous ventilation to at least equal a target ventilation.

3. A method as claimed in claim 1, wherein ventilatory support is positive pressure ventilatory support.

4. A method as claimed in claim 3, wherein the degree of ventilatory support is a difference between a peak inspiratory pressure and an end expiratory pressure.

5. A method as claimed in claim 1, wherein the step of deriving a measure of instantaneous ventilation comprises at least the steps of:

deriving a signal proportional to a measure of respiratory airflow of the subject; and

rectifying said signal.

6. A method as claimed in claim 1, wherein the degree of ventilatory support provided is clipped to prevent the degree of ventilatory support from falling below a minimum degree of support, and said minimum degree of support is less than a degree of support that is required to perform a subject'"'"'s entire work of breathing.

7. A method as claimed in claim 1, wherein the degree of ventilatory support provided is clipped to not exceed a maximum degree of support, chosen to be sufficient to perform most or all of a subject'"'"'s work of breathing, but not sufficient to be dangerous.

8. A method as claimed in claim 1, further including the steps of determining a severity of reduction in ventilation;

and adjusting the degree of ventilatory support according to the following rules;

if the severity of reduction in ventilation is high, then said ventilatory support is provided at a preset rate;

if the severity of reduction in ventilation is zero, then said ventilatory support is provided in phase with the subject'"'"'s respiratory airflow; and

for intermediate degrees of severity of reduction in ventilation, support is provided at an intermediate rate.

9. A method as claimed in claim 8, wherein the severity of reduction in ventilation is calculated by comparing ventilation of the subject with a low pass filtered ventilation.

10. A method for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of

providing a subject with ventilatory support;

deriving a measure of instantaneous ventilation of the subject;

deriving a measure of longterm average ventilation of the subject;

setting a controlled variable of a servo-controller to a function of said measure of instantaneous ventilation;

setting a reference variable of said servo-controller to said measure of longterm average ventilation; and

adjusting a magnitude of said ventilatory support in accordance with an output of said servo-controller.

11. Apparatus for the treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising:

a device for providing ventilatory support of controllable magnitude;

means for deriving a signal indicative of a measure of instantaneous ventilation of a subject; and

a servo-controller operable to control a degree of ventilatory support provided by said ventilatory support device to oppose short-term changes in said measure of instantaneous ventilation, but to permit longterm changes in said measure of instantaneous ventilation.

12. Apparatus as claimed in claim 11, wherein the ventilatory support device provides positive pressure ventilatory support.

13. Apparatus as claimed in claim 11, wherein the servo-controller is further operable to clip the degree of ventilatory support to prevent the degree of ventilatory support from falling below a minimum degree of support, wherein said minimum degree of support is less than a degree of ventilatory support that is required to perform a subject'"'"'s entire work of breathing.

14. Apparatus as claimed in claim 11, wherein the servo-controller is operable to modulate said degree of ventilatory support in phase with respiratory air flow where the subject is breathing adequately, and to modulate said degree of ventilatory support at a preset rate where the subject is not breathing adequately.

15. Apparatus as claimed in claim 14, wherein the servo-controller is operable to assess adequacy of breathing by comparing a measure of instantaneous ventilation with a target ventilation.

18. Apparatus as claimed in claim 11 or claim 17, wherein said measure of instantaneous ventilation is profortional to an absolute value of a measure of respiratory airflow.

21. Apparatus as claimed in claim 18, wherein said target ventilation is a chosen fraction of the measure of longterm average ventilation.

22. Apparatus as claimed in claim 18, wherein the servo-controller is operable to servo-control said measure of instantaneous ventilation to at least equal the target ventilation.

23. Apparatus as claimed in either one of claim 15 or claim 22, wherein the servo-controller is operable to increase the magnitude of ventilatory support if said measure of instantaneous ventilation is less than said target ventilation, and reduce the magnitude of support if said measure of instantaneous ventilation is greater than said target ventilation.

16. Apparatus for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising:

a controllable source of breathable gas at positive pressure;

means for delivering said breathable gas at positive pressure to a subject'"'"'s airway;

means for deriving a measure of the subject'"'"'s instantaneous ventilation; and

a servo-controller for adjusting a degree of ventilatory support to reduce changes in said measure of instantaneous ventilation over a time scale similar to that of a waxing-waning cycle of untreated Cheyne-Stokes breathing or central sleep apnea, while allowing changes in said measure of instantaneous ventilation over a time scale much longer than said waxing-waning cycle.

17. Apparatus for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising:

a controllable source of breathable gas at positive pressure;

means for delivering said breathable gas at positive pressure to a subject'"'"'s airway;

means for deriving a measure of instantaneous ventilation of the subject;

means for deriving a measure of longterm average ventilation of the subject;

means for deriving a target ventilation as a function of said measure of longterm average ventilation;

a servo-controller whose input variable is a function of said measure of instantaneous ventilation, and said servo-controller with a reference variable that is said target ventilation; and

means for adjusting a magnitude of ventilatory support according to an output of the servo-controller.

19. Apparatus as claimed in claim 17, further comprising a low pass filter to filter an absolute value of a measure of respiratory airflow, wherein said measure of longterm average ventilation is proportional to a low pass filtered absolute value of the measure of respiratory airflow, said low pass filter having a time constant of an order of, or longer than, a waxing-waning cycle of untreated Cheyne-Stokes breathing.

20. Apparatus as claimed in claim 19, wherein said time constant is about 100 seconds.

24. A method for the treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of:

providing a subject with positive pressure ventilatory support, with controllable amplitude and rate;

deriving a measure of instantaneous ventilation of the subject;

adjusting said amplitude by;

(a) low pass filtering said measure of instantaneous ventilation to derive a measure of recent average ventilation;

(b) setting a target ventilation equal to a fraction of said measure of recent average ventilation; and

(c) servo-controlling said measure of instantaneous ventilation to at least equal the target ventilation, by adjusting a degree of ventilatory support;

and continuously adjusting said rate by;

(a) to an extent that the measure of instantaneous ventilation equals or exceeds said target ventilation, modulating said positive pressure in phase with respiratory airflow; and

(b) to the extent that the instantaneous ventilation is less than said target ventilation, modulating said amplitude at a preset rate.

25. Apparatus for the treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising:

ventilator means for providing ventilatory support with controllable amplitude and rate;

sensor and processing means for deriving a signal indicative of instantaneous ventilation of a subject; and

servo-control means operable to adjust the amplitude by low pass filtering said instantaneous ventilation signal to derive a measure of recent average ventilation, setting a target ventilation equal to a fraction of said measure of recent average ventilation, and servo-controlling said measure of instantaneous ventilation to at least equal the target ventilation, and further operable to continuously adjust said rate by modulating said support in phase with respiratory airflow to an extent that the instantaneous ventilation equals or exceeds said target ventilation, and modulating said positive pressure at a preset rate to an extent that the instantaneous ventilation is less than said target ventilation.

26. A method for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of:

providing a subject with ventilatory support;

deriving a measure of instantaneous ventilation; and

adjusting a degree of ventilatory support to oppose short term changes in said measure of instantaneous ventilation, but permitting longterm changes in said measure of instantaneous ventilation.

27. A method for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of:

providing a subject with ventilatory support;

deriving a measure of instantaneous ventilation of said subject;

deriving a measure of average ventilation of said subject;

calculating a target value as a function of said measure of average ventilation; and

adjusting a degree of ventilatory support as a function of said measure of instantaneous ventilation and said target value to (a) change said ventilatory support over a time scale similar to that of a waxing-waning cycle of untreated Cheyne-Stokes breathing or central sleep apnea to oppose changes in said measure of instantaneous ventilation, and (b) allow changes in said measure of instantaneous ventilation over a time scale much longer than said waxing-waning cycle.

28. The method of claim 27 wherein said measure of average ventilation is a longterm average ventilation.

29. The method of claim 28 wherein said target value is a fraction of said measure of average ventilation.

30. The method of claim 29 wherein said fraction is about 95%.

31. The method of claim 28 further comprising the step of calculating an instantaneous phase as a continuous variable;

wherein said degree of ventilatory support is adjusted also as a function of said instantaneous phase.

32. The method of claim 31 wherein said instantaneous phase is calculated by application of a set of fuzzy inference rules using membership functions represented by fuzzy sets on a measure of respiratory airflow.

33. The method of claim 32 wherein said set of fuzzy inference rules comprises:

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

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

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

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

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

(f) If the measure of respiratory airflow is positive and a phase is expiratory, then a phase is about 0 revolutions;

(g) If the measure of respiratory airflow is negative and a phase is inspiratory, then a phase is about 0.5 revolutions;

(h) If a low pass filtered absolute value of the measure of respiratory airflow is small, a phase is increasing at a fixed rate equal to an expected respiratory rate of the subject;

(i) If a low pass filtered absolute value of the measure of respiratory airflow is large, a phase is increasing at a steady rate equal to an existing low pass filtered rate of change of phase.

34. The method of claim 31 wherein said instantaneous phase is inspiratory if said measure of respiratory airflow is positive and expiratory otherwise.

35. A method for treatment of cardiac failure, Cheyne-Stokes breathing or central sleep apnea, comprising the steps of:

providing a subject with ventilatory support;

deriving a measure of instantaneous ventilation of said subject; and

adjusting a degree of ventilatory support as a function of said measure of instantaneous ventilation so as to change said ventilatory support over a time scale similar to that of a waxing-waning cycle of untreated Cheyne-Stokes breathing or sleep apnea to oppose changes in said measure of instantaneous ventilation, and allowing changes in said measure of instantaneous ventilation over a time scale much longer than said waxing-waning cycle.