Systems to detect vagus capture

• US 8,594,805 B2
• Filed: 08/15/2012
• Issued: 11/26/2013
• Est. Priority Date: 08/23/2011
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Hincapie Ordonez, Juan Gabriel, Hahn, Stephen J., Ternes, David J., Arcot-Krishnamurthy, Shantha, Hamann, Jason J.
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/586,432
• Publication Number:
  US 20130053926A1
• Time in Patent Office: 468 Days
• Field of Search: 607/62, 607/28, 607/7, 600/380
• US Class Current: 607/62
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/389 Electromyography [EMG]
• CPC Class Codes: A61B 5/395 Details of stimulation, e.g. nerve stimulation to elicit EMG response
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Some embodiments provide a system for delivering neurostimulation. Some system embodiments comprise a lead configured to be implanted in the body, a stimulation output circuit configured to deliver neurostimulation pulses to the vagus nerve through the lead, an EMG sensing circuit configured to use the lead to sense EMG signals from laryngeal muscle activity, and an evoked muscular response detection circuit configured to use the EMG signals sensed by the EMG sensing circuit to detect evoked laryngeal muscle activity evoked by the neurostimulation pulse.

Claims

1. A system for delivering neurostimulation to a body having a vagus nerve, a recurrent laryngeal nerve and laryngeal muscles, the system comprising:

a lead configured to be implanted in the body;

a stimulation output circuit configured to deliver neurostimulation pulses to the vagus nerve through the lead;

an EMG sensing circuit configured to use the lead to sense EMG signals from laryngeal muscle activity; and

an evoked muscular response detection circuit configured to use the EMG signals sensed by the EMG sensing circuit to detect evoked laryngeal muscle activity evoked by the neurostimulation pulses,

wherein the lead includes a vagal nerve cuff and the nerve cuff includes recording electrodes configured to be used to sense EMG signals from laryngeal muscle activity.

2. The system of claim 1, wherein the nerve cuff includes electrodes configured to be used to both sense EMG signals caused by laryngeal muscle activity and to stimulate the vagus nerve.

3. A system for delivering neurostimulation to a body having a vagus nerve, a recurrent laryngeal nerve and laryngeal muscles, the system comprising:

a lead configured to be implanted in the body;

a stimulation output circuit configured to deliver neurostimulation pulses to the vagus nerve through the lead;

an EMG sensing circuit configured to use the lead to sense EMG signals from laryngeal muscle activity; and

an evoked muscular response detection circuit configured to use the EMG signals sensed by the EMG sensing circuit to detect evoked laryngeal muscle activity evoked by the neurostimulation pulses, wherein the evoked muscular response detection circuit comprises;

a detection timer configured to time a delay interval after delivery of one of the neurostimulation pulses, and configured to time a detection window starting upon expiration of the delay interval; and

a comparator configured to detect the evoked laryngeal muscle activity by comparing the EMG signals sensed by the EMG sensing circuit within the detection window to a template or by comparing a value derived from the EMG signals sensed by the EMG sensing circuit within the detection window to a threshold value.

4. The system of claim 3, wherein:

the lead has a first set of electrodes and a second set of electrodes, wherein the first set of electrodes is proximate to a distal end of the lead;

the EMG sensing circuit is configured to use the first set of electrodes to sense EMG signals from laryngeal muscle activity; and

the stimulation output circuit is configured to use the second set of electrodes to deliver neurostimulation pulses to the vagus nerve through the lead.

5. The system of claim 3, wherein the lead is configured to be implanted extravascularly within a carotid sheath, the stimulation output circuit is configured to use the lead implanted extravascularly within the carotid sheath to stimulate the vagus nerve, and the EMG sensing circuit is configured to use the lead implanted extravascularly within the carotid sheath to sense EMG signals from laryngeal activity.

6. The system of claim 3, wherein:

the lead has a first set of electrodes and a second set of electrodes, wherein the first set of electrodes is proximate to a distal end of the lead and, when implanted, the second set of electrodes is more caudal than the first set of electrodes and is more cranial than a point where the recurrent laryngeal nerve branches from the vagus nerve;

the EMG sensing circuit is configured to use the first set of electrodes to sense EMG signals from laryngeal muscle activity; and

the stimulation output circuit is configured to use the second set of electrodes to deliver neurostimulation pulses to the vagus nerve through the lead.

7. The system of claim 3, wherein the lead is configured to be intravascularly inserted into an internal jugular vein, the stimulation output circuit is configured to use the lead to transvascularly stimulate the vagus nerve, and the EMG sensing circuit is configured to use the lead to sense EMG signals from laryngeal activity.

8. The system of claim 3, wherein the detection window begins about 8 ms and ends about 12 ms after delivery of one of the stimulation pulses.

9. The system of claim 3, wherein the comparator is configured to detect the evoked laryngeal muscle activity by comparing the EMG signals sensed by the EMG sensing circuit to a patient-specific template.

10. The system of claim 3, wherein the system is configured to generate an active recharge pulse after each neurostimulation pulse, and wherein the active recharge pulse is completed during the time delay interval.

11. The system of claim 3, wherein the system is configured to generate a passive recharge after each neurostimulation pulse, interrupt the passive recharge during the detection window, and resume the passive recharge after completion of the detection window.

12. The system of claim 3, wherein the evoked muscular response detection circuit includes a measurement module configured to measure one or more characteristic parameters of the evoked laryngeal muscle activity and generate a signal representative of the one or more characteristic parameters.

13. The system of claim 3, wherein the evoked muscular response detection circuit is configured to use a programmed schedule to enable the evoked muscular response detection circuit to detect the evoked laryngeal muscle activity.

14. The system of claim 3, wherein the evoked muscular response detection circuit is configured to respond to a physician-initiated command signal to enable the evoked muscular response detection circuit to detect the evoked laryngeal muscle activity.

15. The system of claim 3, wherein the evoked muscular response detection circuit is configured to respond to a patient-initiated command signal to enable the evoked muscular response detection circuit to detect the evoked laryngeal muscle activity.

16. The system of claim 3, wherein the system is configured to detect an event, and the evoked muscular response detection circuit is configured to detect the evoked laryngeal muscle activity in response to detecting the event.

17. The system of claim 3, further comprising a context sensor and a context sensing circuit configured to provide a contextual signal for the EMG signals sensed by the EMG sensing circuit, wherein the evoked muscular response detection circuit is configured to use the contextual signal and the EMG signals sensed by the EMG sensing circuit to detect evoked laryngeal muscle activity evoked by the neurostimulation pulses.

18. The system of claim 3, wherein the lead includes a vagal nerve cuff.

19. A system for delivering neurostimulation to a body having a vagus nerve, a recurrent laryngeal nerve and laryngeal muscles, the system comprising:

a lead configured to be implanted in the body;

a stimulation output circuit configured to deliver neurostimulation pulses to the vagus nerve through the lead;

an EMG sensing circuit configured to use the lead to sense EMG signals from laryngeal muscle activity;

an evoked muscular response detection circuit configured to use the EMG signals sensed by the EMG sensing circuit to detect evoked laryngeal muscle activity evoked by the neurostimulation pulses; and

a control circuit connected to the evoked muscular response detection circuit and the stimulation output circuit, and configured to adjust a parameter of the neurostimulation pulses to evoke desired laryngeal muscle activity.

20. The system of claim 19, wherein the evoked muscular response detection circuit comprises:

a detection timer configured to time a delay interval after delivery of one of the neurostimulation pulses, and configured to time a detection window starting upon expiration of the delay interval, wherein the detection window begins about 8 ms and ends about 12 ms after delivery of one of the stimulation pulses; and

a comparator configured to detect the evoked laryngeal muscle activity by comparing the EMG signals sensed by the EMG sensing circuit within the detection window to a template or by comparing a value derived from the EMG signals sensed by the EMG sensing circuit within the detection window to a threshold value.