Method for increasing the therapeutic ratio/usage range in a neurostimulator

• US 7,127,296 B2
• Filed: 11/01/2002
• Issued: 10/24/2006
• Est. Priority Date: 11/02/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Bradley, Kerry
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US10/285,817
• Publication Number:
  US 20030093134A1
• Time in Patent Office: 1,453 Days
• Field of Search: 607/43, 607/46, 607 55- 57, 607 62- 63
• US Class Current: 607/46
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A system and method for patient control of the stimulation parameters of a Spinal Cord Stimulation (SCS) system, or other neurostimulation system, provides an increased Therapeutic Ratio (TR). Measurements of the just-perceptible stimulation level and the maximum-comfortable stimulation level are made for at least two values of pulse duration and two values of pulse amplitude. A Therapeutic Ratio is determined for stimulation level control strategies based on fixed pulse duration and variable pulse amplitude, and alternatively for fixed pulse amplitude and variable pulse duration. The control strategy providing the greatest therapeutic ratio is then selected for use by the patient. In an alternative embodiment, the pulse durations at the just-perceptible and maximum-comfortable stimulation levels are measured, and the pulse amplitudes at the just-perceptible and maximum-comfortable stimulation levels are determined using a curve-fitting process. Similarly, the pulse amplitudes may first be measured and the pulse widths determined using a curve-fitting process.

Claims

1. A method for maximizing the therapeutic ratio (TR) of a neurostimulator system, wherein the therapeutic ratio is defined as the ratio of a maximum comfortable stimulation level (numerator) to a just-perceivable stimulation level (denominator), comprising:

determining the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations;

determining the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations;

determining a fixed duration therapeutic ratio for each of the at least two fixed pulse durations;

determining the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes;

determining the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes;

determining a fixed amplitude therapeutic ratio for each the at least two fixed pulse amplitudes; and

selecting a stimulation level control strategy that maximizes the therapeutic ratio.

2. The method of claim 1 wherein:

determining the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations comprises measuring the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations;

determining the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations comprises measuring the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations;

determining the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes comprises measuring the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes; and

determining the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes comprises measuring the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes.

3. The method of claim 1 wherein:

determining the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations comprises measuring the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations;

determining the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations comprises measuring the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations;

determining the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes comprises applying a curve fitting method to determine the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes; and

determining the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes comprises applying a curve fitting method to determine the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes.

4. The method of claim 3 wherein the applying a curve fitting method comprises applying a Weiss and/or La Picque formulation.

5. The method of claim 3 wherein applying a curve fitting method comprises applying a Weiss and/or La Picque formulation.

6. The method of claim 1 wherein:

determining the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations comprises applying a curve fitting method to determine the pulse amplitudes of the just-perceptible stimulation level for a patient for at least two fixed pulse durations;

determining the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations comprises applying a curve fitting method to determine the pulse amplitudes of the maximum comfortable stimulation level for the patient for the at least two fixed pulse durations;

determining the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes comprises measuring the pulse durations of the just-perceptible stimulation level for the patient for at least two fixed pulse amplitudes; and

determining the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes comprises measuring the pulse durations of the maximum comfortable stimulation level for the patient for the at least two fixed pulse amplitudes.

7. The method of claim 1 wherein selecting a stimulation level control strategy that maximizes the therapeutic ratio comprises:

selecting a largest therapeutic ratio as the largest of the set consisting of the fixed duration therapeutic ratios and the fixed amplitude therapeutic ratios;

wherein if the largest therapeutic ratio results from one of the at least two fixed pulse amplitudes;

selecting a fixed parameter to be the one of the at least two fixed pulse amplitudes resulting in the largest therapeutic ratio; and

selecting a variable parameter to be the pulse duration; and

wherein if the largest therapeutic ratio resulted from one of the at least two fixed pulse durations

selecting the fixed parameter to be the one of the at least two fixed pulse durations resulting in the largest therapeutic ratio; and

selecting the variable parameter to be the pulse amplitude; and

selecting a stimulation level control strategy that includes the fixed parameter and the variable parameter.

8. The method of claim 7 wherein selecting a stimulation level control strategy further comprises providing the selected fixed parameter and the selected variable parameter as recommended stimulation parameters.

9. The method of claim 7 wherein selecting a stimulation level control strategy further comprises automatically providing the selected fixed parameter and the selected variable parameter to the neurostimulator system for use as stimulation parameters.

10. The method of claim 7 wherein selecting a largest therapeutic ratio comprises:

selecting a largest therapeutic ratio as the largest of the set consisting of the fixed duration therapeutic ratios and the fixed amplitude therapeutic ratios; and

wherein if two or more of the set consisting of the fixed duration therapeutic ratios and the fixed amplitude therapeutic ratios have approximately the same largest value, selecting the largest therapeutic ratio which results in the smallest current drain on a power source of the system.

11. The method of claim 1 wherein the at least two fixed pulse durations comprise at least five fixed pulse durations, and wherein the at least two fixed pulse amplitudes comprise at least five fixed pulse amplitudes.

12. The method of claim 1 wherein the neurostimulator system comprises a Spinal Cord Stimulation (SCS) system.

13. An implantable neural stimulation system comprising:

an electrode array;

an Implantable Pulse Generator (IPG);

an electrical connection between the IPG and the electrode array; and

means for controlling the IPG based on a stimulation strategy that produces a large Therapeutic Ratio (TR) wherein the therapeutic ratio is defined as the ratio of a maximum comfortable stimulation level to a just-perceivable stimulation level.

14. The system of claim 13 wherein the means for controlling the IPG so as to provide a large TR comprises means for determining a stimulation level control strategy that maximizes the TR by selecting one of a fixed pulse duration control strategy and a fixed pulse amplitude control strategy as a function of which results in the largest TR.

15. A method for maximizing the therapeutic ratio (TR) of a neurostimulator system, comprising:

(a) selecting one of at least two fixed pulse durations;

(b) performing the following steps;

(1) providing neurostimulation to a patient at the selected fixed pulse duration and with a varying pulse amplitude,

(2) computing a lower amplitude-duration (AD) product as the product of the selected fixed stimulation duration and the stimulation amplitude at the just-perceptible stimulation level, and

(3) computing an upper AD product as the product of the selected fixed stimulation duration and the stimulation amplitude at the maximum comfortable stimulation level;

(c) selecting a new one of the at least two fixed pulse durations and repeating steps (b)(1) through (b)(3) for the newly selected fixed pulse duration;

(d) selecting the one of the at least two fixed pulse durations which resulted in the smallest lower AD product and the pulse amplitude that resulted in the smallest lower AD product as the minimum stimulation level;

(e) selecting the one of the at least two fixed pulse durations which resulted in the greatest upper AD product and the pulse amplitude that resulted in the greatest upper AD product as the maximum stimulation level; and

(f) creating a stimulation level control strategy that runs from the minimum stimulation level to the maximum stimulation level.

16. The method of claim 15 wherein creating a stimulation level control strategy that runs from the minimum stimulation level to the maximum stimulation level comprises:

measuring at least one just-perceptible stimulation level and at least one maximum comfortable stimulation level for at least one intermediate pulse duration between the pulse duration of the minimum stimulation level and the pulse duration of the maximum stimulation level; and

interpolating at least one intermediate pulse amplitude between the pulse amplitude of the just-perceptible stimulation level and the pulse amplitude of the maximum comfortable stimulation level; and

fitting curves between the minimum stimulation level and at least one intermediate stimulation level at the at least one intermediate pulse duration, and between the at least one intermediate stimulation level and the maximum stimulation level.