Detection of vasovagal syncope

• US 7,647,106 B2
• Filed: 04/23/2003
• Issued: 01/12/2010
• Est. Priority Date: 04/23/2003
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Virag, Nathalie, Vetter, Rolf, Sutton, Richard
• Primary Examiner(s): Sykes; Angela D
• Assistant Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US10/422,069
• Publication Number:
  US 20040215263A1
• Time in Patent Office: 2,456 Days
• Field of Search: 607/17
• US Class Current: 607/17
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/352 Detecting R peaks, e.g. for synchronising diagnostic apparatus; Estimating R-R interval
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters

Abstract

It has been discovered that a change in posture that results in an increase in orthostatic stress, when followed by a withdrawal of sympathetic nervous activity, may indicate a future onset of vasovagal syncope (VVS). The invention is directed to devices and techniques for early detection of an episode of VVS so that therapies may be applied in advance of the episode to prevent the episode from occurring. Detection of a posture transition triggers a device such as an implanted pacemaker to determine an indicator of an autonomic nervous system activity of the patient. As a function of this determination, the device estimates a probability that the patient will experience VVS. When the probability exceeds a threshold, preventative therapy may be applied to address the VVS and to reduce the risk that the patient will faint.

Claims

1. A method comprising:

detecting a posture transition of a patient;

monitoring autonomic nervous system activity of the patient for a defined period in response to detecting the posture transition;

determining a baseline indicator of the autonomic nervous system activity during the monitoring period;

following the monitoring period, continuing monitoring of the autonomic nervous system activity of the patient during a subsequent period;

determining, based upon monitoring during the subsequent period, an indicator of an autonomic nervous system activity of the patient;

comparing the indicator based upon monitoring during the subsequent period to the baseline indicator; and

estimating a probability that the patient will experience vasovagal syncope as a function of the comparing step.

2. A method according to claim 1, wherein detecting a posture transition comprises detecting a posture transition that increases orthostatic stress.

3. A method according to claim 1, wherein determining the indicator of the autonomic nervous system activity comprises determining a sympatho-vagal balance.

4. A method according to claim 1, wherein determining the indicator of the autonomic nervous system activity comprises determining at least one of cardiac sympathetic nervous activity and cardiac parasympathetic nervous activity.

5. A method according to claim 1, wherein determining the indicator of the autonomic nervous system activity comprises:

detecting at least one physiological signal that includes a sympathetic activity indicator and a parasympathetic activity indicator;

determining the sympathetic activity indicator;

determining the parasympathetic activity indicator; and

estimating the relative magnitude of the sympathetic activity indicator in comparison to the parasympathetic activity indicator.

6. A method according to claim 5, further comprising:

detecting at least a second physiological signal that includes the sympathetic activity indicator and the parasympathetic activity indicator; and

applying blind source separation to the physiological signals to determine the sympathetic activity indicator and the parasympathetic activity indicator.

7. A method according to claim 5, wherein the physiological signal comprises at least one of a heart rate, a heart interval and a blood pressure.

8. A method according to claim 1, wherein the baseline indicator of the autonomic nervous system activity comprises a cumulative measure of the indicator of the autonomic nervous system activity and at least one physiological signal during the monitoring period.

9. A method according to claim 1, wherein determining the baseline indicator comprises sensing at least one physiological signal.

10. A method according to claim 9, wherein the physiological signal comprises at least one of a heart rate, a heart interval and a blood pressure.

11. A method according to claim 1, further comprising:

sensing at least one physiological signal during the monitoring period;

generating a measure of the physiological signal as a function of the sensing during the monitoring period;

sensing the physiological signal following the monitoring period; and

normalizing the physiological signal following the monitoring period with respect to the measure.

12. A method according to claim 1, further comprising normalizing the indicator to the baseline indicator.

13. A method according to claim 1, further comprising:

sensing at least one physiological signal; and

determining the indicator of an autonomic nervous system activity of the patient as a function of the physiological signal.

14. A method according to claim 1, further comprising the step of delivering a therapeutic output to the patient based on a comparison of the probability to a threshold.

15. A method according to claim 14, wherein the step of delivering step occurs if the probability exceeds the threshold.

16. A computer-readable medium comprising instructions for causing a programmable processor to:

detect a posture transition of a patient;

monitor autonomic nervous system activity of the patient for a defined period beginning upon detecting the posture transition;

determine a baseline indicator of the autonomic nervous system activity during the monitoring period;

following the monitoring period, continuing to monitor the autonomic nervous system activity of the patient during a subsequent period;

determine, an indicator of autonomic nervous system activity of the patient based upon monitoring during the subsequent period;

comparing the indicator to the baseline indicator; and

estimate the probability that the patient will experience vasovagal syncope as a function of the comparing step.

17. A medium according to claim 16, wherein the instructions causing the processor to detect a posture transition of a patient comprise instructions causing the processor to detect a posture transition that increases orthostatic stress.

18. A medium according to claim 16, wherein the instructions causing the processor to determine the indicator of the autonomic nervous system activity comprise instructions causing the processor to determine a sympatho-vagal balance.

19. A medium according to claim 16, wherein the instructions causing the processor to determine the indicator of the autonomic nervous system activity comprise instructions causing the processor to determine at least one of cardiac sympathetic nervous activity and cardiac parasympathetic nervous activity.

20. A medium according to claim 16, wherein the instructions causing the processor to determine the indicator of the autonomic nervous system activity comprise instructions causing the processor to:

detect at least one physiological signal that includes a sympathetic activity indicator and a parasympathetic activity indicator;

determine the sympathetic activity indicator;

determine the parasympathetic activity indicator; and

estimate the relative magnitude of the sympathetic activity indicator in comparison to the parasympathetic activity indicator.

21. A medium according to claim 20, the instructions further causing the processor to:

detect at least a second physiological signal that includes the sympathetic activity indicator and the parasympathetic activity indicator; and

apply blind source separation to the physiological signals to determine the sympathetic activity indicator and the parasympathetic activity indicator.

22. A computer readable medium according to claim 16, further comprising instructions for causing a programmable processor to deliver a therapeutic output to the patient based on a comparison of the probability to a threshold.

23. A computer readable medium according to claim 22, wherein the programmable processor delivers the therapeutic output if the probability exceeds the threshold.

24. A device comprising:

a first sensor adapted to detect a posture transition of a patient and provide a posture transition signal upon detecting the posture transition;

a second sensor to sense a physiological signal that includes an indicator of autonomic nervous system activity; and

a processor, configured to;

monitor the physiological signal during a defined period following detection of the posture transition;

determine a baseline indicator of the autonomic nervous system activity during the monitoring period;

following the monitoring period, continue monitoring the autonomic nervous system activity of the patient during a subsequent period and

determine based upon monitoring during the subsequent period the indicator of autonomic nervous system activity;

wherein the device further comprises further comprising a memory module adapted to store the baseline indicator of the autonomic nervous system activity;

characterized in that the processor is further configured to compare the indicator based upon monitoring during the subsequent period to the baseline indicator and to estimate the probability that the patient will experience vasovagal syncope as a function of the comparison.

25. A device according to claim 24, wherein the first sensor comprises an accelerometer.

26. A device according to claim 24, wherein the processor is further configured to determine a sympathetic activity indicator from a physiological signal, determine a parasympathetic activity indicator from the physiological signal and estimate the relative magnitude of the sympathetic activity indicator in comparison to the parasympathetic activity indicator.

27. A device according to claim 26, further comprising a third sensor to sense a second physiological signal that includes an indicator of autonomic nervous system activity, wherein the processor is further configured to apply blind source separation to the first and second physiological signal to determine the sympathetic activity indicator and the parasympathetic activity indicator.

28. A device according to claim 24, wherein the second sensor comprises at least one of a heart rate sensor, a heart interval sensor and a blood pressure sensor.

29. A device according to claim 24, wherein the processor is further configured to deliver a therapeutic output to the patient based on a comparison of the probability to a threshold.

30. A device according to claim 29, wherein the processor delivers the therapeutic output if the probability exceeds the threshold.