NEUROSTIMULATION SYSTEM AND METHOD FOR AUTOMATICALLY ADJUSTING STIMULATION AND REDUCING ENERGY REQUIREMENTS USING EVOKED ACTION POTENTIAL

• US 20140243926A1
• Filed: 02/21/2014
• Published: 08/28/2014
• Est. Priority Date: 02/22/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Carcieri, Stephen
• Granted Patent: US 9,533,148 B2
• Time in Patent Office: Days
• US Class Current: 607/46
• CPC Class Codes: A61B 2560/0209 adapted for power saving
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/377 using evoked responses
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61N 1/36062 Spinal stimulation
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/36146 specified by the stimulation parameters
• CPC Class Codes: A61N 1/36175 Pulse width or duty cycle
• CPC Class Codes: A61N 1/36185 Selection of the electrode configuration
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A neurostimulation system comprising stimulation output circuitry configured for delivering stimulation pulses to target tissue in accordance with a set of stimulation parameters. The neurostimulation system comprises monitoring circuitry configured for continuously measuring action potentials evoked in the target tissue in response to the delivery of the stimulation pulses to the target tissue, memory configured for storing a characteristic of a reference evoked action potential, and at least one processor configured for initiating an automatic mode, in which a characteristic of the measured evoked action potentials is compared to the corresponding characteristic of the reference evoked action potential, and one or more stimulation parameter values in the set of stimulation parameters are adjusted to decrease or increase the energy level of the stimulation pulses, thereby evoking action potentials in the target tissue having substantially the same corresponding characteristic as the reference evoked action potential.

Claims

1. A neurostimulation system, comprising:

stimulation output circuitry configured for delivering stimulation pulses to target tissue in accordance with a set of stimulation parameters;

monitoring circuitry configured for continuously measuring action potentials evoked in the target tissue in response to the delivery of the stimulation pulses to the target tissue;

memory configured for storing a characteristic of a reference evoked action potential; and

at least one processor configured for initiating an automatic mode, in which a characteristic of the measured evoked action potentials is compared to the corresponding characteristic of the reference evoked action potential, and one or more stimulation parameter values in the set of stimulation parameters are adjusted to decrease or increase the energy level of the stimulation pulses, thereby evoking action potentials in the target tissue having substantially the same corresponding characteristic as the reference evoked action potential.

2. The neurostimulation system of claim 1, wherein the set of stimulation parameters includes at least one of a pulse amplitude, a pulse width, a pulse rate, a duty cycle, a burst rate, and an electrode combination.

3. The neurostimulation system of claim 1, wherein the characteristic of the measured evoked action potentials and the characteristic of the reference evoked action potential include at least one of peak delay, width, amplitude, and waveform morphology.

4. The neurostimulation system of claim 1, wherein the measured evoked action potentials include one of an evoked compound action potential and an evoked compound muscle action potential.

5. The neurostimulation system of claim 1, wherein the reference evoked action potential is a therapeutic evoked action potential.

6. The neurostimulation system of claim 1, wherein the reference evoked action potential is a side-effect evoked action potential.

7. The neurostimulation system of claim 1, wherein the at least one processor is configured for triggering the automatic mode based on one or more of the following pre-defined conditions:

a. immediately upon measuring evoked action potentials having a characteristic different from the characteristic of the reference evoked action potential;

b. upon measuring evoked action potentials having a characteristic different from the characteristic of the reference action evoked action potential by more than a predetermined tolerance threshold;

c. upon measuring evoked action potentials having a characteristic different from the characteristic of the reference evoked action potential for more than a predetermined time period; and

d. upon measuring evoked action potentials having a characteristic different from the characteristic of the reference evoked action potential for more than a predetermined number of measurements.

8. The neurostimulation system of claim 1, wherein the at least one processor is configured for halting or resuming the automatic mode based on one or more conditions comprising patient'"'"'s movement, patient'"'"'s temperature, patient'"'"'s blood flow, electrocortigram, electroencephalogram, tissue or transcutaneous oxygen tension, glucose concentration, impedance measurement, chemical species concentration, and whether the patient is asleep or awake.

9. The neurostimulation system of claim 1, wherein the at least one processor is configured for selecting the stimulation parameter to be adjusted and the step size for the adjustment.

10. The neurostimulation system of claim 1, wherein the at least one processor is configured for generating an alert upon initiating the automatic stimulation adjustment mode, thereby allowing manual adjustment of the one or more stimulation parameter values.

11. The neurostimulation system of claim 1, wherein the at least one processor is configured for alternately using two or more of the reference evoked action potentials based on a predefined therapeutic schedule.

12. The neurostimulation system of claim 1, wherein the automatic mode is an automatic stimulation adjustment mode.

13. The neurostimulation system of claim 12, wherein the at least one processor is configured for using the comparison between the measured evoked action potentials and the reference evoked action potential to determine whether the stimulation pulses delivered to the target tissue was an over-stimulation or an under-stimulation of the target tissue, and the one or more stimulation parameter values are adjusted to gradually decrease or increase the energy level of the stimulation pulses, respectively, until the measured evoked action potentials have substantially the same characteristic as the reference evoked action potential.

14. The neurostimulation system of claim 1, wherein the automatic mode is an automatic power consumption optimization mode.

15. The neurostimulation system of claim 14, wherein the one or more stimulation parameter values are adjusted to decrease the energy level of the stimulation pulses, thereby evoking action potentials in the target tissue having substantially the same corresponding characteristic as the reference evoked action potential.

16. The neurostimulation system of claim 14, wherein the memory is configured for storing a threshold stimulation parameter value and a template identifying the characteristic of the reference evoked action potential, and the at least one processor is configured for:

(a) adjusting at least one stimulation parameter value in the threshold stimulation parameter set by a step size;

(b) measuring an action potential evoked in the target tissue by actuating the stimulation output circuitry to generate a stimulation pulse in accordance with the at least one stimulation parameter value;

(c) comparing the measured evoked action potential to the template;

(d) replacing the threshold stimulation parameter value in the threshold stimulation parameter set with the at least one adjusted stimulation parameter value when the characteristic of the measured evoked action potential matches the template; and

(e) repeating steps (a)-(d) to identify the most energy efficient set of stimulation parameters capable of generating evoked action potential from the target tissue having substantially the same characteristic as the reference evoked action potential.

17. The neurostimulation system of claim 1, wherein the stimulation output circuitry, the monitoring circuitry, the at least one processor, and the memory are implemented in a single device.

18. The neurostimulation system of claim 1, wherein the single device is an implantable electric pulse generator.

19. The neurostimulation system of claim 1, wherein the stimulation output circuitry, the monitoring circuitry, the at least one processor, and the memory are implemented with a plurality of devices.