Systems and methods to reduce syncope risk during neural stimulation therapy

• US 9,403,007 B2
• Filed: 05/14/2013
• Issued: 08/02/2016
• Est. Priority Date: 06/14/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Mokelke, Eric A., Shome, Shibaji, Alvarez, Guy, Bos, Harlan, Stein, Kenneth Martin, Hatlestad, John D.
• Primary Examiner(s): KAHELIN, MICHAEL WILLIAM
• Application Number:
  US13/894,348
• Publication Number:
  US 20130338727A1
• Time in Patent Office: 1,176 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/1116 Determining posture transitions
• CPC Class Codes: A61B 5/1118 Determining activity level
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset

Abstract

Some embodiments, by way of example, provide a system, comprising a posture change detector configured to detect a posture transition indicative of an increased risk of syncope, and a neural stimulator configured to deliver a neural stimulation therapy. The neural stimulator may include a syncope avoidance module configured to respond to a detected posture transition by temporarily overriding the neural stimulation therapy to ameliorate the risk of increased syncope.

Claims

1. A system, comprising:

a posture change detector configured to detect posture transitions including a posture change determined to be indicative of an increased risk of syncope; and

a neural stimulator configured to deliver a scheduled neural stimulation therapy, the neural stimulator including a syncope avoidance module configured to temporarily override the scheduled neural stimulation therapy to ameliorate the risk of increased syncope only in response to detecting the posture change that is determined to be indicative of the increased risk of syncope, and then return to the scheduled neural stimulation therapy after the risk of syncope from the detected posture change has subsided.

2. The system of claim 1, wherein the posture change detector comprises a posture monitor including:

an activity sensor configured to sense patient activity;

an activity sampler configured to control the activity sensor to sample patient activity and detect an increase in patient activity;

a posture sensor configured to sense patient posture; and

a posture sampler configured to control the posture sensor, in response to a detected increase in patient activity, to sample patient posture.

3. The system of claim 1, wherein the posture change detector includes an accelerometer.

4. The system of claim 3, wherein the posture change detector includes a 3-axis accelerometer.

5. The system of claim 1, wherein the posture change detector includes:

a posture monitor configured to monitor posture; and

a posture analyzer configured to detect a significant change in the monitored posture, the significant change determined to be the posture change indicative of the increased risk of syncope.

6. The system of claim 5, wherein the posture monitor includes at least one posture sensor configured to sense a patient posture, and a posture sampler configured to sample the sensed patient posture.

7. The system of claim 5, wherein the posture analyzer is configured to detect a posture change greater than a threshold.

8. The system of claim 7, wherein the posture analyzer is further configured to detect a rate of posture change.

9. The system of claim 5, wherein the posture analyzer is configured to sense at least two posture states, and detect at least one posture state change.

10. The system of claim 5, wherein the posture analyzer is configured to determine if the posture change is a change toward a more upright state or a change toward a more reclined state.

11. The system of claim 5, wherein the posture analyzer is configured to receive a contextual input, and use the contextual input to determine if a posture change is a significant posture change, wherein the contextual input includes at least one input selected from the group of inputs consisting of:

a current posture state;

at least one sensed physiological parameter;

a clock; and

a circadian rhythm input.

12. The system of claim 5, wherein:

the posture monitor includes at least two sensors selected from the group of sensors consisting of;

a posture sensor;

an activity sensor; and

an accelerometer; and

the posture analyzer is configured to detect the significant change in the monitored posture that increases the risk of syncope using the at least two sensors.

13. The system of claim 1, wherein the neural stimulator is configured to temporarily adjust an autonomic nervous system (ANS) stimulation to reduce parasympathetic activity or increase sympathetic activity in response to detecting the posture change, allowing increased blood pressure to rise to ameliorate the risk of increased syncope.

14. The system of claim 1, wherein the neural stimulator is configured to deliver a chronic baroreflex stimulation therapy, the chronic baroreflex stimulation therapy including intermittent stimulation of alternating stimulation ON and stimulation OFF periods, each stimulation ON period including a train of neural stimulation pulses.

15. The system of claim 14, wherein the chronic baroreflex stimulation therapy includes a hypertension therapy or a heart failure therapy.

16. The system of claim 14, wherein the syncope avoidance module is configured to respond to the detected posture transition by preventing the intermittent stimulation from initiating the train of stimulation pulses for a time after the detected posture transition.

17. A method implemented using a system that includes a posture change detector configured to detect posture transitions including a posture change determined to be indicative of an increased risk of syncope and a neural stimulator that includes a syncope avoidance module, the method comprising:

delivering a scheduled neural stimulation therapy using the neural stimulator;

detecting the posture change, using the posture change detector, determined to be indicative of the increased risk of syncope; and

temporarily overriding the scheduled neural stimulation therapy, using the syncope avoidance module, only in response to detecting the posture change determined to be indicative of the increased risk of syncope to ameliorate the risk of increased syncope, and then returning to the scheduled neural stimulation therapy after the risk of syncope from the detected posture change has subsided.

18. The method of claim 17, wherein temporarily overriding the scheduled neural stimulation therapy includes temporarily an autonomic nervous system (ANS) stimulation to reduce parasympathetic activity or increase sympathetic activity, allowing increased blood pressure to rise to ameliorate the risk of increased syncope.

19. The method of claim 17, wherein:

delivering the neural stimulation therapy includes delivering a chronic baroreflex stimulation therapy with intermittent stimulation of alternating stimulation ON and stimulation OFF periods, each stimulation ON period including a train of neural stimulation pulses; and

temporarily overriding the neural stimulation therapy includes preventing initiation of the train of stimulation pulses for a time after the detected posture transition.

20. The method of claim 17, wherein detecting the posture transition includes:

sampling patient activity using an activity sensor configured to sense patient activity and detect an increase in patient activity; and

sampling patient posture in response to a detected increase in patient activity using a posture sensor configured to sense patient posture.