Model-Based Optimization of Spinal Cord Stimulation Electrodes

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Solution Overview

Problem

Current spinal cord stimulation (SCS) devices face issues with poor pain coverage, lead migration, and lead breakage, leading to costly and risky revision surgeries, due to inefficient lead design and placement methods.

Innovation Solution

The development of model-based optimization techniques using patient-specific electroanatomical models and genetic algorithms to determine optimal electrode configurations for selective activation of targeted neural elements, reducing energy consumption and minimizing activation of non-targeted elements.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If trial and error experimentation is used to determine lead design and placement, then some functional outcome is achieved, but the process is inefficient and unlikely to lead to optimal results

Engineering Contradiction:

Improveoptimization efficiencyVSAvoidoptimization reliability

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent performs preliminary computational modeling and simulation of electrode configurations before actual implantation. Patient-specific electroanatomical models are created in advance to predict and optimize electrode placement and stimulation parameters, eliminating the need for trial-and-error adjustments after surgery.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent creates virtual copies of the patient's electroanatomical structures through computational modeling. These digital twins allow for virtual testing of multiple electrode configurations without physical trial implants, enabling optimization in silico before actual deployment.

Inventive Principle:

Principle #26Copying

2Adaptability or versatility

If the number of electrodes in arrays is increased to improve pain coverage and reduce sensitivity to placement variations, then programming capability is enhanced, but programming complexity becomes a challenge

Engineering Contradiction:

Improveprogramming capabilityVSAvoidprogramming complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent optimizes the number, spacing, and configuration parameters of electrodes through computational modeling. By systematically varying these parameters in silico, the method identifies optimal configurations that provide adequate pain coverage with minimal electrodes, thereby reducing programming complexity while maintaining versatility.

Inventive Principle:

Principle #35Parameter changes

3Reliability

If percutaneous arrays are used with longitudinal bipolar and tripolar configurations, then selective activation of dorsal column fibers is improved, but the design and placement process remains inefficient

Engineering Contradiction:

Improveselective activationVSAvoiddesign efficiency

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent performs preliminary computational modeling to determine the optimal longitudinal bipolar and tripolar configurations before implantation. Patient-specific models predict the best electrode spacing, polarity assignments, and stimulation parameters to achieve selective dorsal column activation, eliminating trial-and-error optimization.

Inventive Principle:

Principle #10Preliminary action

4Reliability

If paddle arrays are used with transverse tripolar configurations, then selective activation of dorsal column fibers is improved, but surgical complexity increases

Engineering Contradiction:

Improveselective activationVSAvoidsurgical ease

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent optimizes the transverse tripolar configuration parameters through computational modeling, including electrode spacing, width, and polarity assignments. This systematic optimization identifies configurations that achieve selective activation with simplified surgical implantation procedures.

Inventive Principle:

Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This approach significantly improves the efficiency and efficacy of SCS by reducing power consumption and enhancing selective activation of dorsal column fibers, thereby increasing battery life and reducing the need for revision surgeries.

Implementation Method 1

using model electrodes to stimulate the target neural elements

Methodology Applied

Scientific EffectElectrical stimulation: Electric Field

Implementation Method 2

determining differences in activation thresholds between the target neural elements and the non-target neural elements

Methodology Applied

Scientific EffectElectrical conduction: Conduction (electrical)

Data Source

PatentUS10096386B2Systems and methods for model-based optimization of spinal cord stimulation electrodes and devices

Publication Date: 2018.10.09 DUKE UNIV

AI summary

Systems and methods for model-based optimization of spinal cord stimulation electrodes and devices are disclosed. According to an aspect a method includes providing a patient-specific electroanatomical model including the spine, spinal cord, and a map of target neural elements and non-target neural elements. The method also includes using model electrodes to stimulate the target neural elements. Further, the method includes determining differences in activation thresholds between the target neural elements and the non-target neural elements in a plurality of different configurations of the model electrodes. The method also includes generating an optimal spinal cord stimulation electrode configuration based on the determined differences in activation thresholds.