Autonomic modulation using transient response with intermittent neural stimulation

• US 9,126,044 B2
• Filed: 04/14/2011
• Issued: 09/08/2015
• Est. Priority Date: 04/15/2010
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kramer, Andrew P., Hamann, Jason J.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): TEJANI, ANKIT D
• Application Number:
  US13/086,806
• Publication Number:
  US 20110257708A1
• Time in Patent Office: 1,608 Days
• Field of Search: 607/45
• US Class Current: 1/1
• 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 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

In various method embodiments for operating an implantable neural stimulator to deliver a neural stimulation therapy to an autonomic neural target, the method comprises using the implantable neural stimulator to deliver the neural stimulation therapy to the autonomic neural target, and evaluating an evoked response to the neural stimulation bursts. The neural stimulation therapy includes a plurality of neural stimulation bursts where each neural stimulation burst includes a plurality of neural stimulation pulses and successive neural stimulation bursts are separated by a time without neural stimulation pulses. Evaluating the evoked response includes sensing the evoked response to the neural stimulation bursts where sensing the evoked response includes sensing at least one physiological parameter affected by the neural stimulation bursts, comparing the sensed evoked response against a baseline, and determining if the evoked response substantially returns to the baseline between neural stimulation bursts.

Claims

1. A method for operating an implantable neural stimulator to deliver a neural stimulation therapy to an autonomic neural target, the method comprising:

using the implantable neural stimulator to deliver the neural stimulation therapy to the autonomic neural target, wherein;

the neural stimulation therapy includes a plurality of neural stimulation bursts;

each neural stimulation burst includes a plurality of neural stimulation pulses; and

successive neural stimulation bursts are separated by a time without neural stimulation pulses;

evaluating an evoked response to the neural stimulation bursts of the neural stimulation therapy, wherein evaluating the evoked response includes;

sensing the evoked response to the neural stimulation bursts, wherein sensing the evoked response includes sensing at least one physiological parameter affected by the neural stimulation bursts;

comparing the sensed evoked response against a baseline; and

determining if the evoked response substantially returns to the baseline between successive neural stimulation bursts of the neural stimulation therapy; and

performing an action including;

automatically changing neural stimulation parameters for the neural stimulation therapy if the evoked response does not substantially return to the baseline;

or

recording results of the comparison in a memory of the implantable neural stimulator for access by a clinician.

2. The method of claim 1, wherein the action includes automatically changing neural stimulation parameters for the neural stimulation therapy if the evoked response does not substantially return to the baseline.

3. The method of claim 1, wherein the action includes recording results of the comparison in a memory of the implantable neural stimulator for access by a clinician.

4. The method of claim 1, wherein sensing at least one physiological parameter includes sensing heart rate.

5. The method of claim 1, wherein sensing at least one physiological parameter includes sensing blood pressure.

6. The method of claim 1, wherein evaluating the evoked response includes determining a duration of the evoked response from the start of the neural stimulation burst until the evoked response substantially returns to the baseline.

7. The method of claim 1, wherein comparing the sensed evoked response against a baseline includes comparing a pattern of the evoked response to a template.

8. The method of claim 1, wherein:

sensing at least one physiological parameter includes providing a time-series of parameter data points, and sampling the data points to provide a pre-stimulation data sample and a post-stimulation data sample; and

comparing the sensed evoked response against a baseline includes performing an autocorrelation of the pre-stimulation data sample and the post-stimulation data sample.

9. The method of claim 1, wherein:

sensing at least one physiological parameter includes providing a time-series of parameter data points, and sampling the data points to provide a series of samples of a fixed duration; and

comparing the evoked response against the baseline includes performing a cross-correlation of the series of samples for the plurality of neural stimulation bursts.

10. The method of claim 1, wherein:

sensing at least one physiological parameter includes providing a time-series of parameter data points and sampling the data points to provide a pre-stimulation data sample and to a post-stimulation data sample; and

comparing the evoked response against the baseline includes;

creating an average pre-stimulation data sample from the pre-stimulation data samples and an average post-stimulation data sample from the post-stimulation data samples;

determining a pre-stimulation range of signal fluctuation for the average pre-stimulation data sample and a post-stimulation range of signal fluctuation for the average post-stimulation data sample; and

comparing the pre-stimulation range to the post-stimulation range.

11. The method of claim 1, wherein sensing at least one physiological parameter includes providing a time-series of parameter data points, and comparing the evoked response against the baseline includes performing a Fourier decomposition of the time-series of parameter data points.

12. The method of claim 1, wherein comparing the evoked response against the baseline includes measuring an evoked response area between a baseline level and the evoked response.

13. The method of claim 12, further comprising measuring an initial response area between the baseline level and an initial response to the evaluated neural stimulation burst, measuring a recovery response area between the baseline level and a recovery response to the evaluated neural stimulation burst, and comparing the recovery response area to the initial response area.

14. The method of claim 13, further comprising adjusting at least one parameter of the neural stimulation therapy based on the comparison of the recovery response area to the initial response area to change at least one of the recovery response area or the initial response area.

15. The method of claim 1, further comprising adjusting at least one parameter of the neural stimulation therapy based on the comparison of the evoked response against the baseline.

16. The method of claim 15, wherein adjusting at least one parameter of the neural stimulation therapy includes adjusting the at least one parameter to drive an oscillatory response that oscillates between an initial response and a recovery response for the sensed parameters.

17. The method of claim 1, wherein the neural stimulation therapy includes a burst duration on the order of 10 seconds for the burst of neural stimulation pulses, a pulse frequency on the order of 20 Hz, and a burst period on the order of one minute.

18. The method of claim 1, wherein using the implantable neural stimulator to deliver the neural stimulation therapy to the autonomic neural target includes stimulating a vagus nerve.

19. The method of claim 18, wherein stimulating the vagus nerve includes stimulating afferent pathways in the vagus nerve without significant stimulation of efferent pathways in the vagus nerve, or stimulating efferent pathways in the vagus nerve without significantly stimulating afferent pathways in the vagus nerve.

20. The method of claim 18, wherein stimulating the vagus nerve includes selecting to stimulate at a first location or a different second location along the vagus nerve to control a distance that action potentials travel through the vagus nerve.

21. A device for delivering a neural stimulation therapy to an autonomic neural target of a patient, the device comprising:

a neural stimulator configured to generate stimulation energy to stimulate the autonomic neural target;

a memory with a programmed neural stimulation therapy stored therein, wherein the therapy includes a plurality of programmable neural stimulation parameters for use in controlling a dose of the neural stimulation therapy, wherein the neural stimulation therapy includes a plurality of neural stimulation bursts, each burst includes a plurality of neural stimulation pulses, and successive bursts are separated by a time without neural stimulation pulses;

a controller configured to communicate with the memory and the neural stimulator to control the neural stimulation therapy using the programmable parameters;

a sensor adapted to sense at least one physiological parameter affected by the neural stimulation bursts and indicative of an evoked response to the neural stimulation therapy; and

a response extractor configured to receive a time series of parameter data from the sensor and to extract evoked response data from the time series of parameter data and configured to determine if the evoked response data substantially returns to the baseline between neural stimulation bursts,

wherein the device is configured to perform an action including;

automatically changing neural stimulation parameters for the neural stimulation therapy if the evoked response does not substantially return to the baseline;

or

recording results of the comparison in a memory of the implantable neural stimulator for access by a clinician.

22. The device of claim 21, wherein the controller is configured to use the extracted evoked response data from the response extractor to adjust the neural stimulation parameters.

23. The device of claim 21, wherein the sensor is configured to sense at least one physiological parameter indicative of an initial response to the neural stimulation, the response extractor is configured to extract initial response data, and the controller is configured to use the extracted initial response data to adjust the neural stimulation parameters.

24. The device of claim 21, wherein the response extractor is configured to process multiple event samples corresponding to multiple neural stimulation bursts, and perform a signal averaging process on the event samples to extract the evoked response data.

25. The device of claim 21, wherein the response extractor is configured to process multiple event samples corresponding to multiple neural stimulation bursts, and perform a correlation function on the event samples to extract the evoked response data.

26. The device of claim 21, wherein the sensor includes at least one sensor configured to sense at least one physiological parameter indicative of an initial response and a recovery response to the neural stimulation, the response extractor is configured to extract initial response data and recovery response data, and the controller is configured to determine an initial response area between the baseline level and an initial response to the evaluated neural stimulation burst, determine a recovery response area between the baseline level and a recovery response to the evaluated neural stimulation burst, and compare the recovery response area to the initial response area.