Method and apparatus for detecting and treating heart failure

• US 8,844,525 B2
• Filed: 06/12/2009
• Issued: 09/30/2014
• Est. Priority Date: 07/25/2008
• Status: Active Grant

• Current Assignee: ResMed Pty Ltd. (ResMed Incorporated)
• Original Assignee: Resmed Limited (ResMed Incorporated)
• Inventors: Schindhelm, Klaus Henry, Wilcox, Ian, Coxon, Rachel Ann
• Primary Examiner(s): Anderson, Lynne
• Application Number:
  US12/483,357
• Publication Number:
  US 20100018530A1
• Time in Patent Office: 1,936 Days
• Field of Search: 12820421-20423, 128/204.26, 128/205.23
• US Class Current: 128/204.23
• CPC Class Codes: A61B 5/0205 Simultaneously evaluating both cardiovascular conditions and different types of body conditions, e.g. heart and respiratory condition
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• 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 5/0873 using optical means
• CPC Class Codes: A61B 5/14552 Details of sensors specially adapted therefor
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 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 16/0069 the speed thereof being controlled by respiratory parameters, e.g. by inhalation
• CPC Class Codes: A61M 16/0666 Nasal cannulas or tubing devices for improving normal breathing through the nose A61F5/08; nose filters A62B23/06; outside holding devices A61M25/02
• CPC Class Codes: A61M 2016/0021 with a proportional output signal, e.g. from a thermistor
• CPC Class Codes: A61M 2016/0033 electrical
• CPC Class Codes: A61M 2016/0036 in the breathing tube and used in both inspiratory and expiratory phase
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3303 Using a biosensor
• CPC Class Codes: A61M 2205/3561 local, e.g. within room or hospital
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2230/04 : Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/06 : Heartbeat rate only
• CPC Class Codes: A61M 2230/202 : partial carbon oxide pressure, e.g. partial dioxide pressure (P-CO2)
• CPC Class Codes: A61M 2230/205 : partial oxygen pressure (P-O2)
• CPC Class Codes: A61M 2230/30 : Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 2230/63 : Motion, e.g. physical activity
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 50/20 : for computer-aided diagnosis, e.g. based on medical expert systems

Abstract

Devices and systems provide methods of detecting a heart failure condition of a patient that may be based on one or more respiratory parameters of a patient. In an example embodiment, a monitoring device determines one or more heart failure condition indicators based on a measure of the patient respiratory airflow and/or a measure of treatment pressure. Respiratory parameters such as respiration rate, hypopneas, apneas, Cheyne-Stokes breathing patterns or apnea-hypopnea counts may be compared to thresholds that are selected to represent a change in the condition of a heart failure patient such as an onset of a decompensation event. Results of the comparisons may trigger a pressure treatment change and/or one or more warnings or messages to notify a patient or physician of a pending change to the patient'"'"'s heart failure condition so that the patient may more immediately seek medical attention to treat the heart failure condition.

Claims

1. A device for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive sensor to generate a signal associated with a characteristic of patient respiration; and

a processor, coupled with the sensor, the processor configured to control and store a determination of a heart failure condition change indicator based on the signal, compare previously stored and determined values of the indicator from one or more previous treatment sessions and determine a risk of a heart failure decompensation event occurring for the patient based on the comparison, wherein the processor is further configured to trigger a heart failure decompensation risk message based on the comparison.

2. The device of claim 1 wherein a determination of a heart failure condition change indicator is based on a threshold comparison that involves a respiratory rate determined from the signal of the non-invasive sensor.

3. The device of claim 2 further comprising a sensor to generate a signal representative of a respiratory treatment pressure, and

wherein a determined heart failure condition change indicator is based on (a) an additional respiratory parameter determined from the respiration measure and (b) a determined treatment pressure, wherein the additional respiratory parameter is an apnea-hypopnea count or apnea count.

4. The device of claim 1 wherein the processor activates a warning based on the heart failure condition change indicator.

5. The device of claim 4 wherein the warning comprises a light signal or a message.

6. The device of claim 4 wherein the message comprises an electronic message to be transmitted.

7. The device of claim 1 further comprising a transmitter coupled with the processor, wherein the processor is further configured to control transmitting of a message including data representing the heart failure condition indicator.

8. The device of claim 1 further comprising a flow generator coupled to the processor and the patient interface, wherein the processor is configured to control generating a flow of breathable gas at a pressure above atmospheric to the patient interface.

9. The device of claim 1 wherein the processor is configured to determine a heart failure condition change indicator with a plurality of threshold comparisons involving a plurality of respiratory parameters determined from a measure of respiratory airflow and wherein the characteristic of respiration is the measure of respiratory airflow.

10. The device of claim 9 wherein the respiratory parameters comprise data representative of one or more apneas and hypopneas experienced by the patient and data representative of one or more Cheyne-Stokes epochs experienced by the patient.

11. The device of claim 1 wherein the processor is configured to determine the heart failure condition change indicator with a threshold comparison involving an oximetry measure and wherein the characteristic of respiration is the oximetry measure.

12. The device of claim 1 further comprising an ultrasonic sensing device and wherein the processor is configured to determine a heart failure condition change indicator based on data determined by the ultrasonic sensing device.

13. The device of claim 1 wherein the processor is configured to determine a heart failure condition change indicator based on a determined heart-rate variability metric.

14. The device of claim 1 wherein the processor is configured to determine a heart failure condition change indicator based on a measure of sympathovagal balance.

15. The device of claim 1 wherein the processor is configured to determine a heart failure condition change indicator based on a measure of gas of a patient'"'"'s blood.

16. The device of claim 15 further comprising a photoploethysmograph to derive the measure of gas.

17. An apparatus for monitoring a patient to evaluate a heart failure condition of the patient comprising:

sensor means for non-invasively determining a measure of a respiration characteristic of the patient;

respiration analysis means for determining a respiratory parameter based on the measure generated by the sensor means; and

analysis means for evaluating at least the respiratory parameter to generate and store a heart failure condition change indicator based on a signal from the sensor means, to compare previously stored and determined values of the indicator from one or more previous treatment sessions and determine a risk of a heart failure decompensation event occurring for the patient based on the comparison, wherein the analysis means is further configured to trigger a heart failure decompensation risk message based on the comparison.

18. The apparatus of claim 17 further comprising means for transmitting a message representing the heart failure condition change indicator.

19. The apparatus of claim 17 further comprising means for warning a user of the system based on the heart failure condition change indicator.

20. The apparatus of claim 17 further comprising a means for delivering pressurized breathable gas to the patient.

21. The apparatus of claim 17 further comprising means for warning a physician of the system based on the heart failure condition change indicator.

22. A system for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive flow sensor coupled with the patient interface, the flow sensor to generate a respiratory airflow signal representative of the patient'"'"'s respiratory airflow; and

a processor configured to control and store a determination of a heart failure condition change indicator based on data from the respiratory airflow signal, compare previously stored and determined values of the indicator from one or more previous treatment sessions and determine a risk of a heart failure decompensation event occurring for the patient based on the comparison, wherein the processor is further configured to trigger a heart failure decompensation risk message based on the comparison.

23. The system of claim 22 wherein a determination of a heart failure condition change indicator is based on a respiratory rate determined from the respiratory airflow signal.

24. The system of claim 23 further comprising a sensor to generate a signal representative of a respiratory treatment pressure, and wherein a determined heart failure condition change indicator is based on (a) an additional respiratory parameter determined from the respiratory airflow and (b) a determined treatment pressure, wherein the additional respiratory parameter is an apnea-hypopnea count or apnea count.

25. The system of claim 22 wherein the processor activates a warning based on the heart failure condition indicator.

26. The system of claim 25 wherein the warning comprises a light activation signal.

27. The system of claim 25 wherein the warning comprises an electronic message to be transmitted, the message including data representing the heart failure condition change indicator.

28. The system of claim 22 further comprising a flow generator coupled to the patient interface, wherein the flow generator is configured to generate a flow of breathable gas at a pressure above atmospheric to the patient interface.

29. The system of claim 22 wherein the processor is configured to determine a heart failure condition indicator with a plurality of threshold comparisons involving a plurality of respiratory parameters determined from the measure of respiratory airflow.

30. The system of claim 29 wherein the respiratory parameters comprise data representative of one or more apneas and hypopneas experienced by the patient and data representative of one or more Cheyne-Stokes epochs experienced by the patient.

31. The system of claim 22 further comprising an ultrasonic sensing device and wherein the processor is configured to determine a heart failure condition change indicator based on data determined by the ultrasonic sensing device.

32. The system of claim 22 wherein the processor is configured to determine a heart failure condition change indicator based on a determined heart-rate variability metric.

33. The system of claim 22 wherein the processor is configured to determine a heart failure condition change indicator based on a measure of sympathovagal balance.

34. The system of claim 22 wherein the processor is configured to determine a heart failure condition change indicator based on a measure of gas of a patient'"'"'s blood.

35. The system of claim 34 further comprising a photoploethysmograph to derive the measure of gas.

36. An apparatus for evaluating a heart failure condition of a patient during respiratory pressure treatment comprising:

a sensor to determine a measure of treatment pressure delivered by a respiratory treatment apparatus; and

a processor coupled with the sensor, the processor configured to control a determination of a heart failure condition change indicator based on changes in the measure of pressure over time, the indicator representing information about a change in a heart failure condition of the patient.

37. The apparatus of claim 36 wherein the processor is configured to determine a measure of respiration of the patient with data from a sensor;

and

wherein the processor is configured to determine the heart failure condition change indicator based on the respiration measure.

38. The apparatus of claim 37 wherein the processor implements a threshold comparison that detects an increase in a proportion of the measure of pressure and an increase in an apnea or AHI count during a common time period.

39. The apparatus of claim 38 further comprising a flow generator coupled with the processor and wherein the processor is configured to control a change to a pressure treatment therapy of the respiratory treatment apparatus in response to the heart failure condition change indicator.

40. The apparatus of claim 39 wherein the change to the pressure treatment therapy comprises initiating control of ventilation support to meet a target ventilation.

41. A device for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive sensor to generate a signal associated with a characteristic of patient respiration, wherein the non-invasive sensor is an ultrasonic sensing device;

a processor, coupled with the sensor, the processor configured to control a determination of a heart failure condition change indicator based on the characteristic of respiration, the indicator representing information about a change in a heart failure condition of the patient, wherein the respiratory parameter is respiratory rate, and

wherein the processor is configured to perform a threshold comparison of the respiratory parameter determined by the processor, a result of the comparison triggers a heart failure condition message, and the processor is configured to determine a heart failure condition change indicator based on data determined by the ultrasonic sensing device.

42. A device for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive sensor to generate a signal associated with a characteristic of patient respiration;

a processor, coupled with the sensor, the processor configured to control a determination of a heart failure condition change indicator based on the characteristic of respiration, the indicator representing information about a change in a heart failure condition of the patient, wherein the respiratory parameter is respiratory rate,

wherein the processor is configured to perform a threshold comparison of the respiratory parameter determined by the processor, a result of the comparison triggers a heart failure condition message, and the processor is configured to determine a heart failure condition change indicator based on a determined heart-rate variability metric.

43. A system for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive flow sensor coupled with the patient interface, the flow sensor to generate a respiratory airflow signal representative of the patient'"'"'s respiratory airflow;

a processor configured to control a determination of a heart failure condition change indicator based on data from the respiratory airflow signal, the indicator representing information about a change in a heart failure condition of the patient; and

an ultrasonic sensing device,

wherein the processor is configured to perform a threshold comparison of a respiratory rate parameter determined from the data by the processor, a result of the comparison triggers a heart failure condition message, and the processor is configured to determine a heart failure condition change indicator based on data determined by the ultrasonic sensing device.

44. A system for monitoring a patient to evaluate a heart failure condition of a patient comprising:

a patient interface;

a non-invasive flow sensor coupled with the patient interface, the flow sensor to generate a respiratory airflow signal representative of the patient'"'"'s respiratory airflow;

a processor configured to control a determination of a heart failure condition change indicator based on data from the respiratory airflow signal, the indicator representing information about a change in a heart failure condition of the patient,

wherein the processor is configured to perform a threshold comparison of a respiratory rate parameter determined from the data by the processor, a result of the comparison triggers a heart failure condition message, and the processor is configured to determine a heart failure condition change indicator based on a determined heart-rate variability metric.