Clinical Effects Map for Electrical Stimulation Parameter Selection

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Solution Overview

Problem

Current implantable electrical stimulation systems face challenges in identifying suitable sets of stimulation parameters for treating conditions or disorders due to the complexity of programming and the number of degrees of freedom, especially with multiple electrodes and directional stimulation.

Innovation Solution

The system generates a clinical effects map by receiving clinical responses for multiple sets of stimulation parameters, determining spatial relationships between electrodes and effect regions, and estimating responses for different parameter sets, facilitating the selection of optimal stimulation parameters through anatomical or stimulation atlases.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple electrodes and directional stimulation are used to improve treatment precision, then manufacturing precision and measurement precision improve, but device complexity increases

Engineering Contradiction:
Improveprecision of identifying suitable stimulation parametersVSAvoidcomplexity of programming stimulation parameters
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent creates a virtual model (clinical effects map) that copies and represents the complex relationship between multiple electrodes, stimulation parameters, and clinical outcomes. This virtual representation allows clinicians to select parameters without directly managing the full complexity of the underlying system, resolving the contradiction by providing a simplified interface that preserves measurement precision.

Inventive Principle:
Principle #26Copying

Solution Approach 2:

The clinical effects map acts as an intermediary between the complex electrode-stimulation-outcome system and the clinician. It translates complex multi-electrode interactions into a visual format that shows predicted clinical outcomes, allowing precise parameter selection without requiring the clinician to understand the full system complexity.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If comprehensive clinical response data is collected for multiple parameter sets to improve treatment effectiveness, then reliability improves, but loss of time increases

Engineering Contradiction:
Improveeffectiveness of electrical stimulation therapyVSAvoidtime for programming and testing parameters
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The system performs preliminary computational analysis to generate the clinical effects map before actual treatment begins. By pre-calculating and visualizing the relationships between parameters and outcomes, the system eliminates the need for time-consuming trial-and-error testing during patient programming, thus maintaining reliability while reducing time loss.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent replaces the mechanical trial-and-error process of parameter testing with a computational model that predicts outcomes. Instead of physically testing multiple parameter sets on the patient (time-consuming), the system uses algorithms to substitute and predict which parameters will work best, maintaining treatment reliability while dramatically reducing programming time.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3651849B1Estimating clinical effects of electrical stimulation
Publication Date: 2023.05.31 BOSTON SCI NEUROMODULATION CORP
  • EP3651849B1 patent drawingFigure 1
  • EP3651849B1 patent drawingFigure 2~3
  • EP3651849B1 patent drawingFigure 4

AI summary

A method for generating a clinical effects map for electrical stimulation using an electrical stimulation lead includes receiving at least one clinical response for stimulation using each of multiple first sets of stimulation parameters where each clinical response is associated with at least one therapeutic effect or side effect. The method also includes determining, using the clinical responses and the first sets of stimulation parameters, a spatial relationship between the electrical stimulation lead and at least one effect region, where each effect region is associated with at least one of the therapeutic effects or side effects; estimating, based on the spatial relationship, at least one clinical response for each of multiple second sets of stimulation parameters; and generating and presenting a clinical effects map illustrating at least the estimated clinical response for one or more of the second sets of stimulation parameters.