METHOD AND APPARATUS FOR OPTIMIZING VAGAL NERVE STIMULATION USING LARYNGEAL ACTIVITY

• US 20100324628A1
• Filed: 08/31/2010
• Published: 12/23/2010
• Est. Priority Date: 09/01/2006
• Status: Active Grant

• Current Assignee: Anthony V. Caparso, Mark Bly, Randy Westlund
• Original Assignee: Anthony V. Caparso, Mark Bly, Randy Westlund
• Inventors: Bly, Mark, Westlund, Randy, Caparso, Anthony V.
• Granted Patent: US 8,290,584 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• 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 5/6822 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 through a lead to a body having a neck, a larynx, and a vagus nerve, the system comprising:

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

a neural stimulation circuit configured to deliver neural stimulation pulses to the vagus nerve; and

a neural stimulation analyzer communicatively coupled to the activity sensor and the neural stimulation circuit, the neural stimulation analyzer including a stimulation threshold analyzer configured to measure a stimulation threshold using the signal indicative of laryngeal activity, the stimulation threshold being a minimum stimulation intensity required for the neural stimulation pulses to elicit a neural response in the vagus nerve.

2. The system of claim 1, wherein the stimulation threshold analyzer comprises a comparator configured to indicate a nerve capture when the amplitude of the signal indicative of laryngeal activity exceeds the nerve capture threshold.

3. The system of claim 2, wherein the stimulation threshold analyzer comprises a stimulation intensity controller configured to increase a stimulation intensity from an initial intensity until the nerve capture is indicated or a predetermined maximum stimulation intensity is reached.

4. The system of claim 3, wherein the stimulation intensity controller is further configured to decrease the stimulation intensity, after the nerve capture is indicated, until the nerve capture is no longer indicated.

5. The system of claim 1, wherein the neural stimulation analyzer further comprises a lead status analyzer configured to detect dislodgement or breakage of the lead by detecting a change in the measured stimulation threshold between measurements.

6. The system of claim 1, wherein the neural stimulation analyzer further comprises a neural injury analyzer configured to detect a nerve injury by monitoring for a change in the measured stimulation threshold over time.

7. The system of claim 1, further comprising a presentation device configured to present indicators of the laryngeal activity and the delivery of the neural stimulation pulses.

8. The system of claim 7, wherein the presentation device comprises a speaker configured to generate an audible tone indicative of one or more of a frequency and a magnitude of the laryngeal activity.

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

10. The system of claim 9, wherein the activity sensor comprises an accelerometer.

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

sensing a signal indicative of laryngeal activity;

delivering neural stimulation pulses through the lead to the vagus nerve; and

determining a stimulation threshold using the signal indicative of laryngeal activity, the stimulation threshold being a minimum stimulation intensity required for the neural stimulation pulses to elicit a neural response in the vagus nerve, the determining performed automatically by a processing circuit.

12. The method of claim 11, wherein determining the stimulation threshold comprises:

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

detecting a nerve capture by comparing an 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 a predetermined maximum stimulation intensity is reached.

13. The method of claim 12, wherein determining the stimulation threshold further comprises decreasing the stimulation intensity, after the nerve capture is detected, until the nerve capture is no longer detected.

14. The method of claim 11, further comprising detecting a lead dislodgement or breakage indicated by a substantial, abnormal change in the stimulation threshold.

15. The method of claim 11, further comprising detecting a neural injury by monitoring for a change in the stimulation threshold over time.

16. The method of claim 11, further comprising presenting indicators of the laryngeal activity.

17. The method of claim 16, wherein presenting the indicators of the laryngeal activity comprises producing an audible tone indicative of frequency and magnitude of the laryngeal activity.

18. The method of claim 16, wherein presenting the indicators of the laryngeal activity comprises turning on one or more light-emitting diodes when an amplitude of the signal indicative of laryngeal activity exceeds a predetermined threshold.

19. The method of claim 11, wherein sensing the signal indicative of laryngeal activity comprises placing an activity sensor on the neck over the larynx, the activity sensor configured to sense the signal indicative of laryngeal activity.

20. The method of claim 19, wherein sensing the signal indicative of laryngeal activity further comprises holding the activity sensor on the neck over the larynx using a neck brace coupled to the activity sensor and configured to wrap around a portion of the neck.