Neural stimulation system providing auto adjustment of stimulus output as a function of sensed impedance

• US 7,317,948 B1
• Filed: 02/11/2003
• Issued: 01/08/2008
• Est. Priority Date: 02/12/2002
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: King, John D H, Thacker, James R
• Primary Examiner(s): Schaetzle; Kennedy J.
• Assistant Examiner(s): LEE, YUN H
• Application Number:
  US10/364,436
• Time in Patent Office: 1,792 Days
• Field of Search: 607/43, 607/46, 607/62, 600/547, 600/594
• US Class Current: 607/62
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/3615 Intensity

Abstract

A neural stimulation system automatically corrects or adjusts the stimulus magnitude (stimulation energy) in order to maintain a comfortable and effective stimulation therapy. Because the changes in impedance associated with the electrode-tissue interface can indicate obstruction of current flow and positional lead displacement, lead impedance can indicate the quantity of electrical stimulation energy that should be delivered to the target neural tissue to provide corrective adjustment. Hence, a change in impedance or morphology of an impedance curve may be used in a feedback loop to indicate that the stimulation energy needs to be adjusted and the system can effectively auto correct the magnitude of stimulation energy to maintain a desired therapeutic effect.

Claims

1. A method of neural stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

correlating impedance changes with predicted stimulation energy adjustments;

initially storing the correlated impedance changes and predicted stimulation energy adjustments in a look-up table;

measuring a change in impedance indicative of variations in the coupling efficiency between stimulation energy output from the IPG and neural tissue;

subsequently analyzing the stored correlated impedance changes and predicted stimulation energy adjustments to determine a desired stimulation energy adjustment correlated to the measured impedance change; and

automatically adjusting the stimulation energy output from the IPG in accordance with the desired stimulation energy adjustment in order to compensate for the variations in the coupling efficiency and thereby maintain an optimal level of therapy.

2. The method of claim 1 wherein the stimulation energy output from the IPG is varied automatically by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

3. The method of claim 1 further comprising cross-referencing the measured impedance change with the correlated impedance changes to determine the adjustment of the stimulation energy output from the IPG.

4. A method of neural stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

measuring impedance indicative of the coupling efficiency between stimulation energy output from the IPG and neural tissue;

correlating impedance changes with predicted stimulation energy adjustments to be output from the IPG by having a patient implanted with the IPG make positional movements to induce changes in measured impedance and recording associated changes in sensation reported by the patient; and

automatically adjusting the stimulation energy output from the IPG in order to compensate for variations in the measured coupling efficiency and thereby maintain an optimal level of therapy.

5. A neural stimulation system, comprising:

at least one electrode;

an implantable pulse generator (IPG) connected to the at least one electrode, wherein the IPG provides stimulation current pulses to the at least one electrode at a prescribed stimulation energy;

means for measuring a characteristic impedance waveform morphology associated with the at least one electrode;

means for correlating characteristic impedance waveform morphologies with predicted stimulation energy adjustments; and

auto correction means for adjusting the prescribed stimulation energy output from the IPG based on the predicted stimulation energy adjustments and the measured characteristic impedance waveform morphology.

6. The system of claim 5 wherein the auto correction means comprises means for cross-referencing the measured characteristic impedance waveform morphology with the correlated characteristic impedance waveform morphologies to determine the adjustment of the stimulation energy output from the IPG.

7. The system of claim 5 wherein the stimulation energy output from the IPG is adjusted by changing pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

8. A method of neural stimulation, comprising:

linking each characteristic impedance morphology caused by an event to a particular corrective adjustment for outputting a predetermined stimulation current from a neural stimulator;

storing linked information representative of each characteristic impedance morphology and the particular corrective adjustment associated therewith in memory;

outputting a constant electrical stimulation current from a neural stimulator;

measuring impedance indicative of the coupling efficiency of between the electrical stimulation current output by the neural stimulator and neural tissue; and

automatically adjusting the stimulation current subsequently output by the neural stimulator by recalling the linked information to compensate for variations in the coupling efficiency indicated by the measured impedance.

9. The method of claim 8 wherein the stimulation current output by the neural stimulator is varied automatically by varying pulse amplitude, pulsewidth, frequency of pulses or some combination of these three stimulus parameters.

10. A method of neural stimulation, the method comprising:

measuring each characteristic impedance morphology caused by a postural movement made by a patient;

linking each characteristic impedance morphology caused by a postural movement to a particular corrective adjustment for outputting a predetermined stimulation energy from a neural stimulator;

storing linked information representative of each characteristic impedance morphology and the particular corrective adjustment associated therewith in memory;

measuring impedance indicative of the coupling efficiency of an electrical stimulation energy output by the neural stimulator and neural tissue; and

recalling the linked information and automatically adjusting stimulation energy output from the neural stimulator to compensate for variations in the measured coupling efficiency.

11. A method of neural stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

correlating impedance changes with predicted stimulation energy adjustments by having a patient implanted with the IPG make positional movements to induce changes in measured impedance and recording impedance measurements as a function of the positional movements;

measuring a change in impedance indicative of variations in the coupling efficiency between stimulation energy output from the IPG and neural tissue; and

automatically adjusting the stimulation energy output from the IPG based on the predicted stimulation energy adjustments and the measured impedance change in order to compensate for the variations in the coupling efficiency and thereby maintain an optimal level of therapy.

12. The method of claim 11 wherein the positional movements comprise sitting to lying, standing to lying, sitting to standing, twisting the torso to one or the other side, standing to sitting, and running.

13. The method of claim 11 wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by recording associated changes in sensation reported by the patient.

14. The method of claim 13 wherein the impedance changes are correlated with the predicted stimulation energy adjustments further by varying the stimulation energy output from the IPG at each particular patient position and determining the perception threshold at the particular patient position and the maximum comfort level at the particular patient position.

15. A method of neural stimulation using an implantable pulse generator (IPG) that is connected to a lead having at least one electrode, the method comprising:

correlating characteristic impedance waveform morphologies with predicted stimulation energy adjustments;

measuring a characteristic impedance waveform morphology indicative of variations in the coupling efficiency between stimulation energy output from the IPG and neural tissue; and

automatically adjusting the stimulation energy output from the IPG based on the predicted stimulation energy adjustments and the measured characteristic impedance waveform morphology in order to compensate for the variations in the coupling efficiency and thereby maintain an optimal level of therapy.