Assisted ventilation to match patient respiratory need

• US 6,532,957 B2
• Filed: 09/23/1997
• Issued: 03/18/2003
• Est. Priority Date: 09/23/1996
• Status: Expired due to Term

• Current Assignee: Resmed Limited (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Berthon-Jones, Michael
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US08/935,785
• Publication Number:
  US 20020023644A1
• Time in Patent Office: 2,002 Days
• Field of Search: 128/200.24, 128/204.18, 128/204.21, 128/204.23
• US Class Current: 128/204.21
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/7264 Classification of physiological signals or data, e.g. using neural networks, statistical classifiers, expert systems or fuzzy systems neural networks per se G06N3/00; expert systems per se G06N5/00
• 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 16/0069 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 16/1055 bacterial
• CPC Class Codes: A61M 16/107 in the inspiratory path
• 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 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/15 Detection of leaks
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

The apparatus provides for the determination of the instantaneous phase in the respiratory cycle, subject'"'"'s average respiration rate and the provision of ventilatory assistance. A microprocessor (16) receives an airflow signal from a pressure transducer (18) coupled to a port (17) at a mask (11). The microprocessor (16) controls a servo (19), that in turn controls the fan motor (20) and thus the pressure of air delivered by the blower (10). The blower (10) is coupled to a subject'"'"'s mask (ii) by a conduit (12). The invention seeks to address the following goals: while the subject is awake and making substantial efforts the delivered assistance should be closely matched in phase with the subject'"'"'s efforts; the machine should automatically adjust the degree of assistance to maintain at least a specified minimum ventilation without relying on the integrity of the subject'"'"'s chemoreflexes; and it should continue to work correctly in the pesence of large leaks.

Claims

1. A method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable comprising the steps of:

calculating a measure of instantaneous respiratory airflow,

calculating a measure of the rate of change of said instantaneous respiratory airflow,

calculating the degree of membership in each of a plurality of fuzzy magnitude and fuzzy rate of change sets from the calculated respiratory airflow and the calculated rate of change of respiratory airflow,

using a plurality of fuzzy inference rules to calculate the degree of membership in each of a plurality of fuzzy phase sets from at least said fuzzy magnitude and fuzzy rate of change sets, and

in a defuzzification step, calculating the instantaneous phase from the calculated degrees of membership in said plurality of fuzzy phase sets.

2. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1, in which said standard airflow is calculated from a target ventilation.

3. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one of said fuzzy inference rules is that if the calculated measure of respiratory airflow is zero and increasing fast, then the phase is at the start of inspiration.

4. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one of said fuzzy inference rules is that if the calculated measure of respiratory airflow is large positive and steady, then the phase is mid-inspiration.

5. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one of said fuzzy inference rules is that if the calculated measure of respiratory airflow is zero and falling fast, then the phase is end-inspiration.

6. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one of said fuzzy inference rules is that if the calculated measure of respiratory airflow is large negative and steady, then the phase is peak-expiration.

7. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one of said fuzzy inference rules is that if the calculated measure of respiratory airflow is zero and steady, then the phase is late-expiration.

8. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which at least two of the fuzzy inference rules are characterized by:

constructing a prototypical expected flow-vs-time waveform f(t),

identifying N features F_i, i=1 to N, of the flow-vs-time waveform f(t),

for each feature F_i determining the phase φ

_i in the respiratory cycle that is characteristic of said feature,

for each feature F_i defining a fuzzy set M_i whose membership function is a function of respiratory airflow, and a fuzzy set C_i whose membership function is a function of a measure of the rate of change of said instantaneous respiratory airflow, chosen such that the fuzzy intersection M_i AND C_i will be larger for points on the prototypical expected waveform whose phases are characteristic of said feature F_i than for points closer to all of the other identified features, and

setting the fuzzy inference rule R_i for the identified feature F_i to be that if flow is M_i AND rate of change of flow is C_i then phase=φ

_i.

9. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 8 wherein the identified features include zero crossings, peaks, inflection points, or plateaus of the prototypical expected flow-vs-time waveform.

10. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which a first rule is that the rate of change of phase is equal to the patient'"'"'s expected respiratory rate, and other rules are based on the phase being a function of the instantaneous respiratory airflow, and the weighting of the first rule relative to the other rules is increased in the case of a high leak.

11. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which a first rule is that the rate of change of phase is equal to the patient'"'"'s expected respiratory rate, and other rules are based on the phase being a function of the instantaneous respiratory airflow, and the weighting of the first rule relative to the other rules is increased in the case of a rapidly changing leak.

12. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which a first rule is that the rate of change of phase is equal to the patient'"'"'s expected respiratory rate, and other rules are based on the phase being a function of the instantaneous respiratory airflow, and the weighting of the first rule relative to the other rules is increased in the case where the patient is breathing less than a specified target ventilation.

13. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one rule is that if flow is zero and steady, then the phase is late expiration, and the weighting of said rule relative to the other rules is decreased when the patient is breathing less than a specified target ventilation.

14. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one rule is that if flow is sufficiently positive, and the current phase sufficiently expiratory, then the phase is early inspiration.

15. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one rule is that if flow is sufficiently negative, and the current phase sufficiently inspiratory, then the phase is early expiration.

16. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein one of said fuzzy inference rules infers that the phase increases at a fixed rate equal to the patient'"'"'s expected respiratory rate.

17. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein one of said fuzzy inference rules infers that the phase increases at a rate equal to the patient'"'"'s observed mean respiratory rate.

18. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein said step of calculating a measure of instantaneous respiratory airflow includes a normalization procedure.

19. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 18 wherein said normalization procedure is performed by dividing said measure of instantaneous respiratory airflow by the patient'"'"'s low-pass filtered instantaneous ventilation.

20. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 18 wherein said normalization procedure is performed by dividing said measure of instantaneous respiratory airflow by a standard airflow.

21. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein said step of calculating a measure of the rate of change of instantaneous respiratory airflow includes a normalization procedure.

22. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 21 wherein said normalization procedure utilizes at least one of a target minute ventilation and a target respiratory frequency.

23. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein said step of calculating a measure of respiratory airflow comprises correcting the measure of respiratory airflow for leak.

24. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein said step of calculating a measure of instantaneous respiratory airflow comprises low pass filtering said measure of instantaneous respiratory airflow.

25. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 24 in which the time constant of said low pass filtering is an increasing function of an estimate of the length of the respiratory cycle.

26. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 24 further comprising correcting the calculated degrees of membership in said plurality of fuzzy phase sets for any phase delay introduced by low pass filtering the patient'"'"'s airflow.

27. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 wherein said fuzzy inference rules are weighted to increase their respective anticipated reliabilities for predicting the instantaneous phase.

28. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one rule is that if flow is switch positive, and the current phase is exp_phase, then the phase is early inspiration.

29. The method for calculating the phase in a patient'"'"'s respiratory cycle as a continuous variable of claim 1 in which one rule is that if flow is switch negative, and the current phase is insp_phase, then the phase is early expiration.