Method and apparatus for non-invasive monitoring of respiratory parameters in sleep disordered breathing

• US 10,398,862 B2
• Filed: 11/18/2015
• Issued: 09/03/2019
• Est. Priority Date: 10/06/2004
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Inventors: Martin, Dion Charles Chewe, Oates, John David
• Primary Examiner(s): Vasat, Peter S
• Application Number:
  US14/944,569
• Publication Number:
  US 20160067433A1
• Time in Patent Office: 1,385 Days
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/087 Measuring breath flow
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• 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 16/026 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 2016/003 with a flowmeter
• CPC Class Codes: A61M 2016/0039 in the inspiratory circuit
• CPC Class Codes: A61M 2230/005 Parameter used as control input for the apparatus
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/205 partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/42 Rate

Abstract

An air delivery system includes a controllable flow generator operable to generate a supply of pressurized breathable gas to be provided to a patient for treatment and a pulse oximeter configured to determine a measure of patient effort during a treatment period and provide a patient effort signal for input to control operation of the flow generator.

Claims

1. An air delivery system, comprising:

a controllable flow generator configured to generate a supply of pressurized breathable gas to be provided to a patient for treatment;

a processor configured to control the controllable flow generator;

a pulse oximeter configured to determine a measure of patient effort during a treatment period and provide a patient effort signal to the processor;

an airflow measurement patient interface configured to measure cardiogenic respiratory flow of the patient and provide a cardiogenic respiratory flow signal to the processor; and

wherein the processor is configured to calculate a pulse transit time based at least in part on the cardiogenic respiratory flow signal and the patient effort signal and control the controllable flow generator based at least in part on the pulse transit time.

2. The air delivery system of claim 1, wherein the measure of patient effort is derived from a pulse oximeter signal.

3. The air delivery system of claim 1, wherein the processor is configured to use the patient effort signal is used to at least one of:

discriminate between open-closed apnea, determine high airway resistance, determine relative work of breathing, augment control algorithms for the controllable flow generator, determine overventilation, and determine sleep state.

4. The air delivery system of claim 1, wherein the processor is configured to use the patient effort signal in conjunction with an airflow signal to distinguish between open and closed airway apneas.

5. The air delivery system of claim 1, wherein the processor is configured to control the controllable flow generator to reduce pressure support when the pulse oximeter determines that the measure of patient effort has increased, and

wherein the processor is configured to control the controllable flow generator to increase pressure support when the pulse oximeter determines that the measure of patient effort has decreased.

6. A respiratory therapy system, comprising:

a controllable flow generator configured to generate a supply of pressurized breathable gas to be provided to a patient for treatment of a health disorder;

a pulse oximeter configured to derive a pulse oximeter signal;

a signal processor configured to receive the pulse oximeter signal and generate a patient effort signal that is indicative of respiratory rate;

an airflow measurement device configured to measure cardiogenic respiratory flow of the patient and generate a cardiogenic respiratory flow signal;

a processor configured to calculate relative variations in pulse transit time based at least in part on the cardiogenic respiratory flow signal and the pulse oximeter signal; and

a feedback controller configured to control the controllable flow generator based at least in part on the relative variations in pulse transit time.

7. The respiratory therapy system of claim 6, wherein the signal processor is configured to process the pulse oximeter signal to remove signals indicative of heart rate and leave signals indicative of respiratory rate.

8. The respiratory therapy system of claim 7, wherein the signal processor employs a low pass filter, peak detector, nadir detector, or averaging.

9. The respiratory therapy system of claim 6, wherein the health disorder is sleep disordered breathing, congestive heart failure, or stroke.

10. The respiratory therapy system of claim 6, wherein the processor is further configured to indicate inadequate pressure support in the absence of respiratory flow limitation and presence of persistently high respiratory effort.

11. The respiratory therapy system of claim 6, wherein the processor is further configured to determine a measure of effort waveshape that is used as an indicator of overventilation.

12. The respiratory therapy system of claim 11, wherein the indicator is used to control the controllable flow generator to titrate a target ventilation.

13. The respiratory therapy system of claim 6, wherein the processor is further configured to determine a venous pulsation.

14. The respiratory therapy system of claim 13, wherein increases in the venous pulsation are used in the feedback controller of the controllable flow generator to limit the supply of pressurized breathable gas.

15. The respiratory therapy system of claim 6, wherein the processor is further configured to determine a vascular compliance.

16. The respiratory therapy system of claim 15, wherein changes in vascular compliance are recorded as patient arousal data.

17. The respiratory therapy system of claim 16, wherein the recorded patient arousal data is used to determine prescribed CPAP levels.

18. An air delivery system for a patient, comprising;

a controllable flow generator configured to generate a supply of pressurized breathable gas to be provided to a patient for treatment;

a pulse oximeter configured to attach to the patient and generate a photoplethysmographic signal;

a pressure sensor configured to sense nasal flow or oro-nasal flow and to generate an airflow signal from the nasal or oro-nasal flow;

an intermediate signal processor configured to receive the photoplethysmographic signal and the airflow signal and to generate a first signal based on the airflow signal and a second signal based on the photoplethysmographic signal; and

a combined processor configured to receive the first signal and the second signal and to generate results based at least in part on the first signal and the second signal, the results being selected from the group consisting of;

delay between respiration changes and blood gas adjustments, circulatory delay, and pulse transit time (PTT),

wherein the combined processor is configured control the controllable flow generator based on at least one from the group consisting of the delay between respiration changes and blood gas adjustments, the circulatory delay, and the pulse transit time (PTT).

19. The air delivery system of claim 18, wherein the first signal is selected from the group consisting of:

inspiratory airflow limitation, expiratory airflow limitation, cardiac timing, respiratory phase, time course of breath amplitude, and derived statistics.

20. The air delivery system of claim 18, wherein the second signal is selected from the group consisting of:

relative indication of respiratory effort, absolute indication of respiratory rate, relative indication of worsening cardiac function, relative indication of venous congestion, relative variation in sympathetic nervous system activity, standard pulse oximetry, arrival time of systolic pulse at periphery, and pulse rate.

21. The air delivery system of claim 18, wherein the combined processor is configured to analyze the first and second signals are analyzed, and

wherein, if the analysis is indicative of elevated levels of SNS activity, or decompensation, the air delivery system is configured to generate an alert.

22. The air delivery system of claim 18, wherein the combined processor is configured to receive a clinical target, the clinical target selected from the group consisting of:

minimum ventilation, nominal ventilation, optimal synchrony, sleep quality, long-term cardiac function, anticipation/prediction of cardiac decompensation, minimum CPAP/EEP/PEEP, maximum CPAP/EEP/PEEP, minimum pressure support, maximum pressure, and average pressure.

23. The air delivery system of claim 18, wherein the combined processor is further configured to indicate heart-failure severity or cardiac decompensation when the results are indicative of circulatory delay.

24. The air delivery system of claim 18, wherein the combined processor is configured to calculate PTT via a delay between cardiogenic flow pulses detected by the pressure sensor at end-expiration at the patient'"'"'s nares, and the arrival time of systolic pulse at the periphery as determined from the photoplethysmographic signal.

25. The air delivery system of claim 24, wherein a pre-ejection period is not present in the cardiogenic flow pulses.

26. The air delivery system of claim 24, wherein the combined processor is configured to ignore respiratory-induced fluctuations in PTT by virtue of measuring the cardiogenic flow pulses at end-expiration.

27. The air delivery system of claim 26, wherein detected PTT variations are caused by blood pressure variations and/or increased arterial tone only.

28. The air delivery system of claim 18, wherein the combined processor is configured to extract respiratory effort information from the photoplethysmographic signal.

29. The air delivery system of claim 28, wherein the respiratory effort information extracted from the photoplethysmographic signal is indicative of one or more of:

breathing pattern, oxygen saturation, arousal or increased systemic vascular resistance (SVR), and high effort periods.

30. The air delivery system of claim 29, wherein the combined processor is configured to detect arousal from PTT.

31. The air delivery system of claim 29, wherein indications of high effort periods enable apnea discrimination and/or respiratory effort related arousal (RERA) classification.