Autonomic arousal detection system and method

• US 9,014,819 B2
• Filed: 11/12/2013
• Issued: 04/21/2015
• Est. Priority Date: 09/18/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Lee, Kent, Ni, Quan, Hartley, Jesse W., Stahmann, Jeffrey E.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US14/077,524
• Publication Number:
  US 20140107506A1
• Time in Patent Office: 525 Days
• Field of Search: 607/116
• US Class Current: 607/116
• CPC Class Codes: A61B 5/0809 by impedance pneumography
• CPC Class Codes: A61B 5/113 occurring during breathing
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4806 Sleep evaluation A61B5/4821 takes precedence; devices for inducing sleep A61M21/02
• CPC Class Codes: A61B 5/4809 Sleep detection, i.e. determining whether a subject is asleep or not
• 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 2205/054 with electrotherapy
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/10 Electroencephalographic signals
• CPC Class Codes: A61M 2230/60 Muscle strain, i.e. measured on the user
• CPC Class Codes: A61M 2230/63 Motion, e.g. physical activity
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 1/36514 controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by two or more physical parameters A61N1/36585

Abstract

Various approaches to detecting arousals from sleep involve generating signals modulated by muscle tone, brainwave activity, and/or other nervous system activity associated with a patient'"'"'s autonomic arousal response. Generating the signals and/or detecting autonomic arousals from sleep may be performed using an implantable device. Arousal information may be useful to identify sleep disorder events associated with arousals from sleep, for diagnostic purposes, and/or for therapy adjustment.

Claims

1. A method for adjusting a patient neurostimulation therapy, comprising:

sensing one or more physiological conditions modulated by a patient'"'"'s autonomic arousal response;

detecting autonomic arousal events occurring during sleep based on the one or more sensed physiological conditions, wherein at least one of sensing the physiological conditions and detecting the autonomic arousal events is performed at least in part implantably;

discriminating between autonomic arousal events associated with sleep disorder events and autonomic arousal events not associated with sleep disorder events; and

adjusting the patient neurostimulation therapy based, at least in part, on the discriminated autonomic arousal events.

2. The method according to claim 1, wherein the patient therapy further comprises a cardiac stimulation therapy, and wherein the method further comprises adjusting the patient cardiac stimulation therapy based, at least in part, on the discriminated autonomic arousal events.

3. The method according to claim 1, wherein the patient therapy further comprises a hypertension therapy, and wherein the method further comprises adjusting the patient hypertension therapy based, at least in part, on the discriminated autonomic arousal events.

4. The method according to claim 1, wherein only autonomic arousal events not associated with sleep disorder events are used in adjusting the neurostimulation therapy.

5. The method of claim 1 wherein the autonomic arousal events are detected by observing an output of an EMG sensor configured to generate a signal modulated with changes in muscle tone associated with autonomic arousal events.

6. A method for monitoring a patient therapy, comprising:

sensing one or more physiological conditions modulated by a patient'"'"'s autonomic arousal response;

detecting autonomic arousal events occurring during sleep based on the one or more sensed physiological conditions, wherein at least one of sensing the physiological conditions and detecting the autonomic arousal events is performed at least in part implantably; and

discriminating between autonomic arousal events associated with sleep disorder events and autonomic arousal events not associated with sleep disorder events; and

monitoring a patient therapy based at, least in part, on the discrimination of the autonomic arousal events.

7. The method according to claim 6, further comprising adjusting the patient therapy based, at least in part, on the detected autonomic arousal events.

8. The method according to claim 6, wherein the patient therapy comprises a neural stimulation therapy.

9. The method according to claim 6, wherein:

sensing the one or more physiological conditions comprises sensing sympathetic nerve activity; and

detecting the autonomic arousal events is based at least in part on the sensed sympathetic nerve activity.

10. The method according to claim 6, wherein the patient therapy comprises a therapy for treating hypertension.

11. The method according to claim 6, further comprising:

determining a trend of the autonomic arousal events; and

using the autonomic arousal event trend to monitoring the patient therapy.

12. The method according to claim 6, wherein:

sensing the one or more physiological conditions comprises sensing heart rate; and

detecting the autonomic arousal events comprises;

determining heart rate variability based on the sensed heart rate; and

detecting one or more of the autonomic arousal events based at least in part on the heart rate variability.

13. The method according to claim 6, wherein:

sensing the one or more physiological conditions comprises sensing at least one physiological condition that is modulated contemporaneously with an occurrence of an autonomic arousal event; and

detecting the autonomic arousal events comprises detecting the autonomic arousal events contemporaneously with modulation of the physiological condition.

14. A medical system for monitoring a patient therapy comprising:

one or more sensors configured to sense one or more physiological conditions associated with a patient'"'"'s autonomic arousal response;

an implantable arousal detector coupled to the one or more sensors, the arousal detector configured to detect autonomic arousal events based on the one or more physiological conditions; and

a controller operatively coupled to the arousal detector, the controller configured to discriminate between autonomic arousal events associated with sleep disorder events and autonomic arousal events not associated with sleep disorder events, and to monitor the patient therapy based at, least in part, on the discriminated autonomic arousal events.

15. The medical system of claim 14 further comprising:

a therapy unit, operatively coupled to the controller, configured to adjust the patient therapy based, at least in part, on the discriminated autonomic arousal events.

16. The medical system of claim 15, wherein the therapy unit is configured to deliver a neurostimulation therapy to the patient, and is further configured to adjust the neurostimulation therapy based, at least in part, on the discriminated autonomic arousal events.

17. The medical system of claim 15, wherein the therapy unit is configured to deliver a cardiac electrical stimulation therapy to the patient, and is further configured to adjust the cardiac electrical stimulation therapy based, at least in part, on the discriminated autonomic arousal events.

18. The medical system of claim 15, wherein the therapy unit is configured to deliver a therapy to treat hypertension in the patient, and is further configured to adjust the therapy based, at least in part, on the discriminated autonomic arousal events.

19. The medical system of claim 14, wherein the controller is configured to determine a trend of the detected autonomic arousal events, and to use the autonomic arousal event trend to monitoring the patient therapy.

20. The medical system of claim 14, wherein the controller is configured to determine an arousal event index based on the detected autonomic arousal events, and to monitor the patient therapy based on the index.