Clinical Effects Mapping for Precise Electrical Stimulation Programming

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Solution Overview

Problem

Existing implantable electrical stimulation systems face challenges in identifying suitable stimulation parameters due to the complexity of programming multiple electrodes, making it difficult to effectively treat conditions while minimizing side effects.

Innovation Solution

A clinical effects map is generated by mapping therapeutic and side effects to the radius of the stimulation field, using different colors or shades to distinguish between them, and incorporating anatomical features, facilitating precise stimulation parameter selection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple electrodes are programmed with different stimulation parameters, then treatment coverage and efficacy are improved, but programming complexity and difficulty increase

Engineering Contradiction:

Improvetreatment coverageVSAvoidprogramming complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent creates a simplified copy or representation of the complex multi-electrode stimulation parameters through graphical user interface elements that visually represent stimulation fields and their effects. This allows clinicians to program complex treatments by manipulating visual representations rather than directly configuring multiple electrodes, thereby maintaining treatment coverage while reducing programming complexity

Inventive Principle:

Principle #26Copying

Solution Approach 2:

The patent introduces an intermediary layer between the clinician and the electrode programming system. This intermediary consists of graphical user interface elements that mediate the programming process by translating complex parameter configurations into visual representations, allowing clinicians to indirectly control multiple electrodes through a simplified interface that reduces cognitive load and programming difficulty

Inventive Principle:

Principle #24Intermediary (Mediator)

2Reliability

If stimulation parameters are optimized for therapeutic regions, then treatment efficacy is improved, but risk of side effects increases due to proximity of stimulated regions

Engineering Contradiction:

Improvetreatment efficacyVSAvoidside effects

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by allowing different stimulation parameters to be assigned to different spatial regions around the lead. The system divides the stimulation space into distinct zones (therapeutic regions vs. side effect regions) and enables independent optimization of parameters for each zone. This allows maximum stimulation intensity in therapeutic regions while maintaining lower or zero intensity in regions known to produce side effects, thereby achieving high treatment efficacy without triggering adverse responses

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent incorporates feedback mechanisms where the system provides visual representation of stimulation field overlap and potential side effect regions based on previously identified sensitive areas. This feedback allows clinicians to adjust programming parameters in real-time to avoid stimulating regions associated with side effects while maintaining effective treatment in therapeutic zones, thus optimizing the balance between efficacy and safety

Inventive Principle:

Principle #23Feedback

3Area of stationary object

If stimulation field radius is increased to cover more tissue, then treatment coverage is improved, but precision of targeting specific regions decreases

Engineering Contradiction:

Improvetreatment coverageVSAvoidtargeting precision

Core Design Contradiction:

Area of stationary objectVSMeasurement precision

Solution Approach 1:

The patent segments the stimulation field into multiple concentric zones or radial regions at different distances from the lead. Each zone can be independently configured with different parameters, allowing the system to provide broad coverage through multiple small targeted zones rather than one large diffuse field. This segmentation enables simultaneous achievement of wide area coverage and precise regional targeting by activating specific segments corresponding to therapeutic regions while leaving other segments inactive or at lower intensity

Inventive Principle:

Principle #1Segmentation

Data Source

PatentEP4415809B1Systems and methods for generating and using response maps for electrical stimulation

Publication Date: 2026.01.28 BOSTON SCI NEUROMODULATION CORP

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AI summary

A method or system for generating a clinical effects map for electrical stimulation includes receiving stimulation parameters and at least one clinical response for each of a plurality of stimulation instances; for each of the stimulation instances, determining a radius of a stimulation field according to the stimulation parameters for the stimulation instance; generating the clinical effects map using the at least one clinical response and the stimulation parameters for each of the stimulation instances, wherein, for each of the stimulation instances, the at least one clinical response for the stimulation instance is assigned to the radius of the stimulation field determined for the stimulation instance; and displaying the clinical effects map.