SYSTEMS AND METHODS FOR AVOIDING NEURAL STIMULATION HABITUATION

• US 20110307025A1
• Filed: 08/25/2011
• Published: 12/15/2011
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Andrew P. Kramer, Imad Libbus
• Original Assignee: Andrew P. Kramer, Imad Libbus
• Inventors: Libbus, Imad, Kramer, Andrew P.
• Granted Patent: US 8,249,711 B2
• Time in Patent Office: Days
• US Class Current: 607/17
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36167 Timing, e.g. stimulation onset
• CPC Class Codes: A61N 1/37235 Aspects of the external programmer

Abstract

An embodiment relates to a method for delivering a vagal stimulation therapy to a vagus nerve, including delivering a neural stimulation signal to non-selectively stimulate both afferent axons and efferent axons in the vagus nerve according to a predetermined schedule for the vagal stimulation therapy, and selecting a value for at least one parameter for the predetermined schedule for the vagal stimulation therapy to control the neural stimulation therapy to avoid physiological habituation to the vagal stimulation therapy. The parameter(s) include at least one parameter selected from the group of parameters consisting of a predetermined therapy duration parameter for a predetermined therapy period, and a predetermined intermittent neural stimulation parameter associated with on/off timing for the intermittent neural stimulation parameter.

Claims

1. A method for delivering a vagal stimulation therapy to a vagus nerve, comprising:

stimulating the vagus nerve, wherein stimulating the vagus nerve includes simultaneously stimulating both afferent axons and efferent axons in the vagus nerve; and

avoiding physiological habituation to stimulating the vagus nerve, wherein avoiding physiological habituation includes scheduling stimulation of the vagus nerve to provide a stimulation schedule using a programmable value for a therapy duration to control a therapy period or a programmable value for an intermittent neural stimulation parameter associated with on/off timing for stimulating the vagus nerve, wherein stimulating the vagus nerve includes stimulating the vagus nerve according to the stimulation schedule.

2. The method of claim 1, wherein stimulating the vagus nerve according to the stimulation schedule includes stimulating the vagus nerve independent of sensed heart rate.

3. The method of claim 1, wherein avoiding physiological habituation includes accounting for each neural stimulation train in the therapy period to provide an indicator for total therapy time using the value for the therapy duration as a minimum therapy duration for the therapy period.

4. The method of claim 3, the method further comprising delivering intermittent therapy during the therapy duration.

5. The method of claim 3, the method further comprising delivering continuous therapy during the therapy duration.

6. The method of claim 1, wherein avoiding physiological habituation includes:

controlling a duty cycle for stimulating the vagus nerve using the programmable value for the intermittent neural stimulation parameter; and

limiting a stimulation period during which the neural stimulation signal is delivered, wherein the duty cycle corresponds to a percentage of the stimulation period.

7. The method of claim 6, wherein the stimulation period is approximately one minute, and delivering the neural stimulation signal includes, for every stimulation period, delivering the neural stimulation signal for approximately ten seconds of the stimulation period and not delivering the neural stimulation signal for approximately fifty seconds of the stimulation period.

8. The method of claim 6, wherein the predetermined duty cycle is less than approximately 25%.

9. The method of claim 6, wherein the predetermined duty cycle is within a range between approximately 10% and 20%.

10. The method of claim 1, further comprising adjusting a stimulation intensity for stimulating the vagus nerve.

11. The method of claim 10, wherein the neural stimulation signal includes a train of pulses, and adjusting the intensity includes adjusting at least one of amplitude, frequency, or pulse width of a train of pulses.

12. The method of claim 10, wherein adjusting the stimulation intensity includes adjusting the stimulation schedule, and avoiding physiological habituation includes limiting intensity adjustments of the stimulation schedule.

13. The method of claim 1, wherein the vagal stimulation therapy includes a therapy selected from a heart failure therapy, a hypertension therapy, or a remodeling therapy.

14. The method of claim 1, further comprising sensing heart rate and delivering myocardial pacing based on sensed heart rate.

15. The method of claim 1, further comprising monitoring for physiological habituation, wherein monitoring includes sensing heart rate to detect physiological habituation, the method further comprising adjusting the stimulation schedule to avoid further physiological habituation to stimulating the vagus nerve.

16. A method for delivering a heart failure therapy in a patient with a vagus nerve, comprising:

stimulating the vagus nerve and avoiding physiological habituation to stimulating the vagus nerve,

wherein stimulating the vagus nerve includes using a neural stimulation signal to simultaneously stimulate both afferent axons and efferent axons in the vagus nerve using a neural stimulation signal, the neural stimulation signal having a frequency of approximately 20 Hz, a pulse width of approximately 300 microseconds, and a duty cycle between 10% and 20% for a stimulation period of approximately 1 minute, and

wherein avoiding physiological habituation includes scheduling stimulation of the vagus nerve for the heart failure therapy using a programmable value for a therapy duration to control a therapy period or a programmable value for an intermittent neural stimulation parameter associated with on/off timing for stimulating the vagus nerve.

17. The method of claim 16, further comprising sensing heart rate, wherein stimulating the vagus nerve according to the stimulation schedule includes stimulating the vagus nerve independent of sensed heart rate.

18. The method of claim 17, further comprising monitoring for physiological habituation using the sensed heart rate to detect physiological habituation, the method further comprising adjusting the stimulation schedule to avoid further physiological habituation to stimulating the vagus nerve.

19. The method of claim 17, further comprising delivering myocardial pacing based on the sensed heart rate.

20. The method of claim 16, wherein using the neural stimulation signal includes incorporating a passive recharge between stimulation pulses.

21. The method of claim 16, wherein stimulating the vagus nerve includes delivering monophasic stimulation pulses.

22. The method of claim 16, further comprising delivering a first train of monophasic pulses of a first polarity, followed by a second train of monophasic pulses of a second polarity opposite to the first polarity.

23. The method of claim 22, further comprising separately adjusting stimulation parameters for the first and second trains of monophasic pulses to control undesired side effects while maintaining a desired therapeutic effect.

24. The method of claim 16, wherein stimulating the vagus nerve includes delivering biphasic stimulation pulses.

25. The method of claim 24, wherein the biphasic stimulation pulses have a first phase with a first polarity and a second phase with a second polarity opposite the first polarity, the method further comprising separately adjusting stimulation parameters for the first and second phases to control undesired side effects while maintaining a desired therapeutic effect.

26. The method of claim 24, wherein stimulating the vagus nerve includes using a bipolar electrode configuration to stimulate the vagus nerve.

27. The method of claim 24, wherein stimulating the vagus nerve includes using a current source pulse output circuit to stimulate the vagus nerve.

28. The method of claim 27, wherein stimulating the vagus nerve includes delivering stimulation pulses within a pulse amplitude between approximately 1.5 mA and approximately 2.0 mA.