SYSTEMS AND METHODS TO ACCOUNT FOR NECK MOVEMENT DURING NERVE STIMULATION

• US 20120271382A1
• Filed: 04/23/2012
• Published: 10/25/2012
• Est. Priority Date: 04/25/2011
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Arcot-Krishnamurthy, Shantha, Ruble, Stephen, Hamann, Jason J., Hincapie Ordonez, Juan Gabriel, Ternes, David J.
• Granted Patent: US 9,314,627 B2
• Time in Patent Office: Days
• US Class Current: 607/62
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36132 using patient feedback
• CPC Class Codes: A61N 1/3614 based on impedance measurement
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration

Abstract

Some embodiments provide a method, comprising performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations. The method further comprises recording threshold data for each of the tested electrode configurations for the plurality of head positions, and recommending an electrode configuration based on the recorded threshold data.

Claims

1. A method, comprising:

performing a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations;

recording threshold data for each of the tested electrode configurations for the plurality of head positions; and

recommending an electrode configuration based on the recorded threshold data.

2. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one intravascular electrode to transvascularly deliver neural stimulation to the neural target.

3. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one electrode in a carotid sheath of the patient to stimulate the neural target.

4. The method of claim 1, wherein performing the neural stimulation test routine includes using at least one electrode lying next to the neural target.

5. The method of claim 1, wherein testing the plurality of electrode configurations includes testing a desired response threshold to neural stimulation.

6. The method of claim 5, wherein the neural target is a cervical vagus nerve and the desired response threshold is a laryngeal vibration threshold.

7. The method of claim 5, further comprising:

determining a highest desired response threshold for each of the electrode configurations using recorded threshold data for each of the head positions,

wherein recommending the electrode configuration based on the recorded threshold data includes recommending an electrode configuration having a lowest value for the highest desired response thresholds.

8. The method of claim 7, wherein the threshold data includes a threshold current amplitude, the method further comprising recommending a stimulation current for the recommended electrode configuration, wherein the recommended stimulation current has an amplitude corresponding to the threshold current amplitude with a safety factor.

9. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes testing an undesired response threshold to neural stimulation.

10. The method of claim 9, wherein the neural target is a cervical vagus nerve and wherein testing an undesired response threshold to neural stimulation includes receiving patient-entered or clinician-entered feedback to provide the threshold data.

11. The method of claim 9, wherein the neural target is a cervical vagus nerve and the undesired response threshold is a cough threshold.

12. The method of claim 9, further comprising determining a lowest undesired threshold for each electrode configuration using recorded threshold data for each head position, wherein recommending the electrode configuration based on the recorded threshold data includes recommending an electrode configuration having a highest value for the lowest undesired response thresholds.

13. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes testing both a desired response threshold and an undesired response threshold to neural stimulation.

14. The method of claim 13, further comprising:

determining both a highest desired response threshold and a lowest undesired response threshold for each electrode configuration using recorded threshold data for each of the head positions;

determining a lowest value for the highest desired response thresholds; and

determining a highest value for the lowest undesired thresholds,

wherein recommending the electrode configuration includes recommending the electrode configuration as a function of both the lowest value for the highest desired response thresholds and the highest value for the lowest undesired response thresholds.

15. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes receiving patient-entered or clinician-entered feedback to provide the threshold data.

16. The method of claim 1, wherein testing the threshold for the plurality of tested electrode configurations includes using an implanted sensor or an external sensor to sense the threshold data.

17. The method of claim 14, wherein the sensors include:

a pressure sensor, an accelerometer, a minute ventilation sensor, an impedance sensor, a sensor configured to detect an electrocardiogram (EKG), a sensor configured to detect an electromyogram (EMG), or a blood pressure sensor.

18. A system for delivering vagal stimulation therapy (VST) to a vagus nerve of a patient, comprising:

a plurality of electrodes configured to be implanted in a cervical region of the patient;

a neural stimulator configured to deliver the VST using at least one electrode configuration from a plurality of potential electrode configurations for the plurality of electrodes;

feedback circuitry configured to receive an indicator of a physiological response to VST, wherein the feedback circuitry includes at least one of a sensor configured to sense at least one physiological parameter or a user input device configured to receive patient-entered or clinician-entered feedback;

a controller connected to the neural stimulator and to the feedback circuitry, wherein the controller is configured to;

perform a neural stimulation test routine for stimulating a neural target in a cervical region of a patient, wherein for each of a plurality of head positions, performing the neural stimulation test routine includes testing a plurality of electrode configurations;

record threshold data for each of the tested electrode configurations for the plurality of head positions; and

recommend an electrode configuration based on the recorded threshold data.

19. The system of claim 18, wherein the plurality of electrodes are configured to be implanted within a blood vessel in the cervical region, and the neural stimulator is configured to transvascularly deliver neural stimulation to the vagus nerve.

20. The system of claim 18, wherein the plurality of electrodes are configured to be implanted within a carotid sheath of the patient, and the neural stimulator is configured to use the electrodes in the carotid sheath to stimulate the vagus nerve.

21. The system of claim 18, wherein the feedback circuitry includes sensors configured to sense laryngeal vibration, and wherein the controller is configured to test a laryngeal vibration threshold for the plurality of potential electrode configurations.

22. The system of claim 21, wherein the controller is configured to determine a highest laryngeal vibration threshold for each of the potential electrode configurations using recorded threshold data for each of the head positions, and determine the desired electrode configuration from the plurality of potential electrode configurations based on the electrode configuration having a lowest value for the highest laryngeal vibration thresholds.

23. The system of claim 22, wherein the threshold data includes a threshold current amplitude, wherein the controller is further configured to recommend a stimulation current for the recommended electrode configuration, wherein the recommended stimulation current has an amplitude corresponding to the threshold current amplitude with a safety factor.

24. The system of claim 18, wherein the feedback circuitry includes sensors configured to sense cough, and wherein the controller is configured to test a cough threshold for the plurality of potential electrode configurations.

25. The system of claim 24, wherein the controller is configured to determine a lowest cough threshold for each of the potential electrode configurations using recorded threshold data for the head positions, and determine the desired electrode configuration from the plurality of potential electrode configurations based on the electrode configuration having a highest value for the lowest cough thresholds.