Spinal Cord Stimulation Guidance Using Impedance and ECAP Modeling

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Solution Overview

Problem

Conventional modeling approaches for spinal cord stimulation (SCS) systems are computationally intensive, require multiple software packages, and are not MRI-compatible, making them difficult to use in clinical settings, with challenges in visualizing dermatomal fiber tracts and determining lead position post-implantation.

Innovation Solution

A method and system for modeling patient-specific spinal cord stimulation using impedance and evoked compound action potential (ECAP) signals to create a patient-specific anatomical model, transforming a dorsal column map template, and solving electromagnetic fields in extracellular and intracellular domains, allowing for faster and more accurate lead positioning and stimulation configuration.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional modeling approaches are used for SCS systems, then detailed anatomical modeling can be achieved, but the computational time and complexity increase significantly

Engineering Contradiction:
Improveanatomical modeling accuracyVSAvoidcomputational time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent extracts only the essential parameters needed for SCS modeling from the full anatomical model. Instead of using complete MRI-based 3D spinal cord models with detailed tissue segmentation, the invention uses a simplified model that focuses on key geometric parameters (spinal cord diameter, lead position, electrode configuration) while eliminating computationally intensive elements like complete dermatomal fiber tract visualization and multi-software package requirements.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent changes the modeling parameters from detailed tissue-level properties to clinically relevant macroscopic parameters. The model uses measurable clinical parameters (lead impedance, electrode spacing, spinal cord dimensions obtainable from standard imaging) rather than requiring complete tissue segmentation and material property assignment for every anatomical structure, thereby reducing computational complexity while maintaining clinical relevance.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If conventional modeling approaches are used, then comprehensive SCS analysis can be performed, but the system requires multiple software packages and specialized personnel

Engineering Contradiction:
Improvemodeling accuracyVSAvoidsoftware requirements
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent merges multiple separate modeling functions into a single integrated computational framework. Instead of requiring separate software packages for MRI processing, tissue segmentation, lead positioning, and stimulation modeling, the invention combines all these functions into one unified model that can be implemented in a single software environment, eliminating the need for multiple specialized tools and reducing operational complexity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a universal modeling framework that can handle various SCS configurations and analysis types within a single system. The model is designed to be adaptable to different lead types, electrode arrangements, and stimulation parameters without requiring separate specialized software for each scenario, making it accessible to clinicians without requiring specialized modeling personnel.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Measurement precision

If detailed SC anatomy is visualized from MRI images, then anatomical precision is improved, but the imaging and processing become more complex and time-consuming

Engineering Contradiction:
Improveanatomical visualization accuracyVSAvoidimaging and processing complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent performs preliminary extraction of essential anatomical parameters from standard MRI images before the detailed modeling process. Instead of requiring complete tissue segmentation and complex image processing during the modeling phase, the invention pre-extracts key measurements (spinal cord diameter, lead position, vertebral level) from routine clinical MRI sequences, thereby simplifying subsequent modeling steps while maintaining anatomical accuracy.

Inventive Principle:
Principle #10Preliminary action

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

Enables efficient, MRI-compatible modeling of SCS systems during office visits, facilitating precise lead placement and stimulation settings based on patient-specific anatomy, reducing computational time and complexity.

Implementation Method 1

acquiring impedance and evoked compound action potential (ECAP) signals from a lead positioned proximate to a spinal cord (SC)

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Implementation Method 2

acquiring impedance and evoked compound action potential (ECAP) signals from a lead positioned proximate to a spinal cord (SC)

Methodology Applied
Scientific EffectElectrical Stimulation and Action Potential: Electrical Resistance

Implementation Method 3

transform a dorsal column (DC) map template based on a DC boundary of the patient-specific anatomical model

Methodology Applied
Scientific EffectElectromagnetic Field Mapping: Electromagnetic Induction

Data Source

PatentUS20250359811A1Spinal cord stimulation guidance system and method of use
Publication Date: 2025.11.27 PACESETTER INC
  • US20250359811A1 patent drawing
  • US20250359811A1 patent drawing
  • US20250359811A1 patent drawing

AI summary

A system and method for modeling patient-specific spinal cord stimulation (SCS) is disclosed. The system and method acquire impedance and evoked compound action potential (ECAP) signals from a lead positioned proximate to a spinal cord (SC). The lead includes at least one electrode. The system and method determine a patient-specific anatomical model based on the impedance and ECAP signals, and transform a dorsal column (DC) map template based on a DC boundary of the patient-specific anatomical model. Further, the system and method map the transformed DC map template to the patient-specific anatomical model. The system and method may also include the algorithms to solve extracellular and intracellular domain electrical fields and propagation along neurons. The system and method may also include the user interfaces to collect patient responses and compare with the patient-specific anatomical model as well as using the patient-specific anatomical model for guiding SCS programming.