Method for providing ventilatory assistance in a spontaneously breathing subject

• US 6,484,719 B1
• Filed: 04/13/2000
• Issued: 11/26/2002
• Est. Priority Date: 09/23/1996
• Status: Expired due to Term

• Current Assignee: ResMed Incorporated
• Original Assignee: ResMed Incorporated
• Inventors: Berthon-Jones, Michael
• Primary Examiner(s): Lewis, Aaron J.
• Application Number:
  US09/549,197
• Time in Patent Office: 957 Days
• Field of Search: 128/204.18, 128/204.21, 128/204.23, 128/202.22, 128/200.24
• US Class Current: 128/204.23
• 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 (27) at a mask (11). The microprocessor (16) controls a servo (19), that is 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 presence of large leaks.

Claims

1. A method for providing ventilatory assistance in a spontaneously breathing subject, comprising the steps, performed at repeated sampling intervals, of:

calculating the instantaneous phase φ

in the respiratory cycle as a continuous variable from 0 to 1 revolution,

selecting a desired pressure modulation amplitude A,

calculating a desired instantaneous delivery pressure as a function of an end expiratory pressure plus the desired pressure modulation amplitude A multiplied by the value of a waveform template function II(φ

) at the calculated instantaneous phase φ

, and

delivering pressure to said subject at the calculated desired instantaneous delivery pressure.

2. A method as in claim 1, wherein the selected desired pressure modulation amplitude A includes a fixed amplitude.

3. A method as in claim 1, wherein the selected desired pressure modulation amplitude A includes a component equal to the elastance multiplied by an estimate of the subject'"'"'s tidal volume.

4. A method as in claim 1, wherein the selected desired pressure modulation amplitude A includes a component calculated using the sub-steps of:

specifying an expected breath duration,

specifying a present pressure modulation amplitude to apply for said expected breath duration,

calculating the actual breath duration of said subject, and

calculating the component of said pressure modulation amplitude as a function of at least said specified preset pressure modulation amplitude multiplied by said calculated actual breath duration divided by the specified expected breath duration.

5. A method as in claim 1 wherein the phase in the respiratory cycle is calculated using the sub-steps of:

determining the extent to which the subject is adequately ventilated,

to said extent setting the phase in the respiratory cycle in accordance with the subject'"'"'s respiratory airflow, and

to the converse extent setting the phase in accordance with a preset respiratory rate.

6. A method as in claim 1, wherein the phase in the respiratory cycle is calculated using the sub-steps of:

estimating respiratory airflow,

deriving a measure of mask leak stability,

to the extent that mask leak is stable, calculating the phase in accordance with the estimate of respiratory airflow, and

to the converse extent, calculating the phase in the respiratory cycle in accordance with a preset respiratory rate.

7. A method as in claim 1, wherein the selected desired pressure modulation amplitude includes a component chosen to servo-control the degree of ventilation to at least exceed a specified ventilation.

8. A method as in claim 7, wherein said component is calculated using the sub-steps of:

calculating an error term proportional to the absolute value of estimated respiratory airflow minus twice said specified ventilation, and

setting said component proportional to the time integral of said error term.

9. A method as in claim 8, wherein the time integral is clipped to fall between a preset minimum and a preset maximum.

10. An apparatus for providing ventilatory assistance in a spontaneously breathing subject comprising:

a delivery means for supplying breathable gas at a controllable pressure to a subject,

a sealed connection means between said delivery means and a subject'"'"'s airway,

a means for determining an airflow signal from said connection means, and

a controller with programmed instructions for controlling;

(a) a calculation of an instantaneous phase φ

in a respiratory cycle as a continuous variable from 0 to 1 revolution from data representing said airflow signal;

(b) a selection of a desired pressure modulation amplitude A;

(c) a calculation of a desired instantaneous delivery pressure as a function of an end expiratory pressure plus the desired pressure modulation amplitude A multiplied by the value of a waveform template function II(φ

) at the calculated instantaneous phase φ

; and

(d) a delivery of pressure to said subject at the calculated desired instantaneous delivery pressure.

11. The apparatus of claim 10, wherein the selected desired pressure modulation amplitude A includes a fixed amplitude.

12. The apparatus of claim 10, wherein the selected desired pressure modulation amplitude A includes a component equal to an elastance multiplied by an estimate of the subject'"'"'s tidal volume.

13. The apparatus of claim 10, with further instructions for controlling the determination of a component of the selected desired pressure modulation amplitude A by:

specifying an expected breath duration,

specifying a preset pressure modulation amplitude to apply for said expected breath duration,

calculating the actual breath duration of said subject, and

calculating the component of said pressure modulation amplitude as a function of at least said specified preset pressure modulation amplitude multiplied by said calculated actual breath duration divided by the specified expected breath duration.

14. The apparatus of claim 10, with further instructions for controlling the calculation of phase in the respiratory cycle by:

determining the extent to which the subject is adequately ventilated,

to said extent setting the phase in the respiratory cycle in accordance with the subject'"'"'s respiratory airflow, and to the converse extent setting the phase in accordance with a preset respiratory rate.

15. The apparatus of claim 10, wherein the instructions for controlling the calculation of phase in the respiratory cycle include controlling the sub-steps of:

estimating respiratory airflow,

deriving a measure of mask leak stability,

to the extent that mask leak is stable, calculating the phase in accordance with the estimate of respiratory airflow, and

to the converse extent, calculating the phase in the respiratory cycle in accordance with a preset respiratory rate.

16. The apparatus of claim 10 wherein the selected desired pressure modulation amplitude includes a component chosen to servo-control the degree of ventilation to at least exceed a specified ventilation.

17. The apparatus of claim 16, in which said component is calculated with instructions controlling the sub-steps of:

calculating an error term proportional to the absolute value of estimated respiratory airflow minus twice said specified ventilation, and

setting said component proportional to the time integral of said error term.

18. The apparatus of claim 17, wherein said time integral is clipped to fall between a preset minimum and a preset maximum.