Autonomic modulation using transient response with intermittent neural stimulation

• US 9,504,833 B2
• Filed: 09/01/2015
• Issued: 11/29/2016
• 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): Gedeon, Brian T
• Assistant Examiner(s): Tejani, Ankit D
• Application Number:
  US14/842,154
• Publication Number:
  US 20150367134A1
• Time in Patent Office: 455 Days
• Field of Search: None
• 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 comprising:

using a neural stimulator system to deliver neural stimulation therapy, 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, using the neural stimulator system, 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; and

performing a statistical analysis of the evoked response to the plurality of neural stimulation bursts to determine if the neural stimulation bursts provide a desired evoked response for the neural stimulation therapy; and

performing an action using the neural stimulation system including;

changing neural stimulation parameters for the neural stimulation therapy if the evoked response does not provide the desired evoked response, or

recording results of the statistical analysis for access by a clinician.

2. The method of claim 1, wherein the action includes changing the neural stimulation parameters and further includes using the statistical analysis of the evoked response to change the neural stimulation parameters.

3. The method of claim 1, wherein the action includes using the neural stimulation system to automatically record results of the comparison in a memory of the implantable neural stimulator for access by a clinician.

4. The method of claim 3, further comprising sampling the evoked response based on timing of neural stimulation events to provide event samples, wherein performing the statistical analysis of the evoked response includes performing a statistical analysis of the event samples.

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

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

7. The method of claim 1, wherein evaluating the evoked response 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

performing the statistical analysis 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

performing the statistical analysis 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 pre-stimulation data samples and to post-stimulation data samples; and

performing the statistical analysis includes performing a statistical analysis using the pre-stimulation data samples and post-stimulation data samples.

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

12. 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.

13. 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.

14. The method of claim 13, 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.

15. A system, 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 perform a statistical analysis of the evoked response data to the plurality of neural stimulation bursts to determine if the neural stimulation bursts provide a desired evoked response for the neural stimulation therapy,

wherein the device is configured to perform an action including;

changing neural stimulation parameters for the neural stimulation therapy if the evoked response does not provide the desired evoked response;

or

recording results of the statistical analysis for access by a clinician.

16. The device of claim 15, wherein the controller is configured to use the statistical analysis of the evoked response data to adjust the neural stimulation parameters.

17. The device of claim 15, 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.

18. The system of claim 15, wherein the sensor includes a heart rate sensor, and the response extractor is configured to extract evoked heart rate response data and perform a statistical analysis of the evoked heart rate response data.

19. The system of claim 15, wherein the sensor includes a blood pressure sensor, and the response extractor is configured to extract evoked blood pressure response data and perform a statistical analysis of the evoked blood pressure response data.

20. The system of claim 15, wherein the response extractor is configured to provide a pre-stimulation data samples and post-stimulation data samples, and is further configured to perform a statistical analysis using the pre-stimulation data samples and the post-stimulation data samples.