Method and apparatus for optimizing vagal nerve stimulation using laryngeal activity

• US 7,801,603 B2
• Filed: 09/01/2006
• Issued: 09/21/2010
• Est. Priority Date: 09/01/2006
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Westlund, Randy, Caparso, Anthony V., Bly, Mark
• Primary Examiner(s): Layno; Carl H
• Assistant Examiner(s): Gedeon; Brian T
• Application Number:
  US11/469,551
• Publication Number:
  US 20080058874A1
• Time in Patent Office: 1,481 Days
• Field of Search: 600/23, 607/41, 607/47, 607/72, 607/1, 607/46
• US Class Current: 607/2
• CPC Class Codes: A61B 5/1104 induced by stimuli or drugs; A61B5/1102 takes precedence; investigating medicinal preparations G01N33/15
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/388 Nerve conduction study, e.g. detecting action potential of peripheral nerves
• CPC Class Codes: A61B 5/6822 Neck
• CPC Class Codes: A61B 5/7203 for noise prevention, reduction or removal
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve 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
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient

Abstract

A neural stimulation system delivers neural stimulation to the vagus nerve and senses a signal indicative of laryngeal activity resulting from the neural stimulation. The signal indicative of laryngeal activity is used, for example, to guide electrode placement, determine stimulation threshold, detect lead/electrode problems, detect neural injury, and monitor healing processing following the electrode placement inside the body of a patient.

Claims

1. A neural stimulation system for applying neural stimulation to a body having a neck, a larynx, and a vagus nerve, the system comprising:

an activity sensor adapted to sense a signal indicative of laryngeal activity;

a laryngeal activity sensor assembly including a neck-bracing structure configured to hold the activity sensor on the neck over the larynx; and

a neural stimulation analyzer communicatively coupled to the activity sensor, the neural stimulation analyzer including;

a laryngeal activity input to receive the signal indicative of laryngeal activity;

a neural stimulation input to receive a signal indicative of a delivery of the neural stimulation to the vagus nerve; and

a processing circuit coupled to the laryngeal activity input and the neural stimulation input, the processing circuit configured to process the signal indicative of laryngeal activity for analyzing the neural stimulation system using the signal indicative of laryngeal activity.

2. The neural stimulation system of claim 1, wherein the activity sensor comprises an accelerometer adapted to sense an acceleration signal being the signal indicative of laryngeal activity.

3. A neural stimulation system for applying neural stimulation to a body having a neck, a larynx, and a vagus nerve, the system comprising:

an activity sensor adapted to sense a signal indicative of laryngeal activity;

a laryngeal activity sensor assembly including the activity sensor and a neck brace configured to wrap around a portion of the neck; and

a neural stimulation analyzer communicatively coupled to the activity sensor, the neural stimulation analyzer including;

a laryngeal activity input to receive the signal indicative of laryngeal activity;

a neural stimulation input to receive a signal indicative of a delivery of the neural stimulation to the vagus nerve; and

a processing circuit coupled to the laryngeal activity input and the neural stimulation input, the processing circuit configured to process the signal indicative of laryngeal activity for analyzing the neural stimulation system using the signal indicative of laryngeal activity.

4. The neural stimulation system of claim 3, wherein the neck brace comprises two ends separated by a gap over an anterior portion of the neck, and the laryngeal activity sensor assembly further comprises:

brackets each affixed onto one of the two ends of the neck brace; and

one or more straps coupled to the brackets and the activity sensor, the one or more straps configured to press the activity sensor on the neck over the larynx.

5. The neural stimulation system of claim 4, wherein the one or more straps are coupled to the brackets in a way allowing adjustment of a position of the activity sensor in cranial/caudal directions.

6. The neural stimulation system of claim 4, wherein the activity sensor comprises a sensor base including a surface curved to fit onto the neck.

7. A neural stimulation system for applying neural stimulation to a body having a neck, a larynx, and a vagus nerve, the system comprising:

an activity sensor adapted to sense a signal indicative of laryngeal activity; and

a neural stimulation analyzer communicatively coupled to the activity sensor, the neural stimulation analyzer including;

a laryngeal activity input to receive the signal indicative of laryngeal activity;

a neural stimulation input to receive a signal indicative of a delivery of the neural stimulation to the vagus nerve;

a signal conditioning circuit adapted to increase a signal-to-noise ratio of the signal indicative of laryngeal activity, the signal including components of the signal indicative of laryngeal activity resulting from the neural stimulation; and

a processing circuit coupled to the laryngeal activity input and the neural stimulation input, the processing circuit configured to process the signal indicative of laryngeal activity for analyzing the neural stimulation system using the signal indicative of laryngeal activity.

8. The neural stimulation system of claim 7, comprising a laryngeal activity sensor assembly including a neck-bracing structure configured to hold the activity sensor on the neck over the larynx.

9. The neural stimulation system of claim 7, further comprising:

stimulation electrodes to deliver the neural stimulation to the vagus nerve; and

a neural stimulation circuit, coupled to the stimulation electrodes, to deliver neural stimulation pulses through to the vagus nerve through the stimulation electrodes.

10. The neural stimulation system of claim 9, further comprising a presentation device adapted to present indicators of the laryngeal activity and the delivery of the neural stimulation pulses.

11. The neural stimulation system of claim 9, wherein the neural stimulation analyzer comprises a stimulation threshold analyzer adapted to measure at least one stimulation threshold automatically, the stimulation threshold being a minimum stimulation intensity required for the neural stimulation pulses to elicit a neural response in the vagus nerve.

12. The neural stimulation system of claim 11, wherein the stimulation threshold analyzer comprises a comparator including a first input to receive an amplitude of the signal indicative of laryngeal activity, a second input to receive a nerve capture threshold, and an output indicative of a nerve capture when the amplitude of the signal indicative of laryngeal activity exceeds the nerve capture threshold.

13. The neural stimulation system of claim 12, wherein the stimulation threshold analyzer comprises a stimulation intensity controller adapted to increase a stimulation intensity from an initial intensity until the nerve capture is indicated or a predetermined maximum stimulation intensity is reached.

14. The neural stimulation system of claim 13, wherein the stimulation intensity controller is further adapted to decrease the stimulation intensity, after the nerve capture is indicated, until the nerve capture is no longer indicated.

15. The neural stimulation system of claim 11, further comprising a transvenous lead including:

a proximal end coupled to the neural stimulation circuit;

a distal end including at least one of the stimulation electrodes; and

an elongate body coupled between the proximal end and the distal end.

16. The neural stimulation system of claim 15, wherein the neural stimulation analyzer comprises a lead status analyzer adapted to produce a warning of lead dislodgment or breakage based on the change in the at least one stimulation threshold associated with the at least one of the stimulation electrodes included in the distal end of the lead between measurements of that stimulation threshold.

17. The neural stimulation system of claim 11, wherein the neural stimulation analyzer comprises a neural injury analyzer adapted to detect a nerve injury by monitoring one or more of a change in the at least one stimulation threshold over time, a change in the amplitude of the signal indicative of laryngeal activity over time, and a change in a neural conduction velocity over time.

18. The neural stimulation system of claim 9, further comprising:

an implantable medical device including the neural stimulation circuit; and

an external system communicatively coupled to the implantable medical device via telemetry, the external system including the neural stimulation analyzer.

19. A neural stimulation system for applying neural stimulation to a body having a neck, a larynx, and a vagus nerve, the system comprising:

an activity sensor adapted to sense a signal indicative of laryngeal activity;

a laryngeal activity sensor assembly configured to hold the activity sensor on the neck over the larynx;

a signal conditioning circuit, communicatively coupled to the activity sensor, to condition the signal indicative of laryngeal activity;

a neural stimulation circuit adapted to deliver the neural stimulation to the vagus nerve; and

a presentation device coupled to the signal conditioning circuit and the neural stimulation circuit, the presentation device adapted to present indicators of the laryngeal activity and the delivery of the neural stimulation.

20. The neural stimulation system of claim 19, wherein the activity sensor comprises an accelerometer.

21. The neural stimulation system of claim 19, wherein the presentation device comprises a speaker configured to produce an audible tone indicative of the laryngeal activity.

22. The neural stimulation system of claim 19, wherein the presentation device comprises a visual indicator configured to produce a visual indication of the laryngeal activity.

23. The neural stimulation system of claim 22, wherein the visual indicator comprises a screen displaying the signal indicative of laryngeal activity and a signal indicative of the neural stimulation.

24. The neural stimulation system of claim 22, wherein the visual indicator comprises one or more light-emitting diodes each turned on when an amplitude of the signal indicative of laryngeal activity exceeds a threshold.

25. The neural stimulation system of claim 22, wherein the visual indicator comprises a gauge indicative of a magnitude of the laryngeal activity.

26. A method for applying neural stimulation to a body having a neck, a larynx, and a vagus nerve, the method comprising:

sensing a signal indicative of laryngeal activity;

delivering the neural stimulation to the vagus nerve;

conditioning the signal indicative of laryngeal activity to isolate laryngeal activity resulting from the delivery of the neural stimulation; and

presenting indicators of the laryngeal activity.

27. The method of claim 26, wherein presenting the indicators of the laryngeal activity comprises producing an audible tone indicative of the laryngeal activity, the audible tone having a pitch indicative at least one of a frequency at which the larynx vibrates and a magnitude of the laryngeal activity.

28. The method of claim 27, wherein presenting the indicators of the laryngeal activity comprises displaying the signal indicative of laryngeal activity on a screen.

29. The method of claim 27, wherein presenting the indicators of the laryngeal activity comprises presenting a magnitude of the laryngeal activity using light emitting diodes.

30. The method of claim 27, wherein presenting the indicators of the laryngeal activity comprises presenting a magnitude of the laryngeal activity using a gauge.

31. The method of claim 26, further comprising determining a stimulation threshold automatically using the signal indicative of laryngeal activity, the stimulation threshold indicative of a minimum stimulation intensity required to capture the vagus nerve by the neural stimulation.

32. The method of claim 31, wherein determining the stimulation threshold automatically comprises:

setting a stimulation intensity of the neural stimulation to an initial intensity;

detecting a nerve capture by comparing the amplitude of the signal indicative of laryngeal activity to a nerve capture threshold; and

increasing the stimulation intensity from the initial intensity until the nerve capture is detected or if a predetermined maximum stimulation intensity is reached before the nerve capture is detected.

33. The method of claim 32, wherein determining the stimulation threshold automatically further comprises decreasing the stimulation intensity, after the nerve capture is detected, until the nerve capture is no longer detected, and further comprising presenting a minimum intensity at which the nerve capture is detected when the stimulation intensity is being decreased as the stimulation threshold.

34. The method of claim 31, further comprising detecting a lead dislodgement or breakage by monitoring a change in the stimulation threshold over two or more measurements of the stimulation threshold.

35. The method of claim 31, further comprising detecting a neural injury by monitoring a change in the stimulation threshold over time.

36. The method of claim 35, further comprising detecting a neural injury by monitoring a change in a neural conduction velocity over time.

37. The method of claim 26, wherein delivering the neural stimulation to the vagus nerve comprises delivering neural stimulation pulses through a stimulation electrode, and further comprising positioning the stimulation electrode by using the laryngeal activity for guidance.

38. The method of claim 37, further comprising monitoring a tissue healing process following an implantation of the stimulation electrode by monitoring a change in the stimulation threshold over time.

39. The method of claim 37, wherein positioning the stimulation electrode comprises electronically selecting one or more active stimulation electrodes from a plurality of available stimulation electrodes.