Segmented Electrode Lead Circumferential Positioning

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Solution Overview

Problem

Current electrical stimulation systems for deep brain stimulation lack precision in targeting specific areas around the electrodes, leading to unwanted stimulation of neighboring neural tissue and potential side effects due to the ring shape of electrodes, which deliver current equally in all directions.

Innovation Solution

The use of segmented electrodes and markers along the lead body to identify the circumferential positioning of electrodes, allowing for directed stimulation by rotating the lead to align electrodes with target neurons, and the implementation of a multi-lumen conductor guide with helical sections for strain relief and conductor pathways.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If ring-shaped electrodes are used to deliver stimulation current, then the electrode structure is simple and current delivery is uniform in all directions, but the stimulation cannot be directed to specific positions around the electrode, resulting in unwanted stimulation of neighboring neural tissue

Engineering Contradiction:
Improvecurrent delivery uniformityVSAvoidunwanted stimulation of neighboring tissue
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The ring electrode is divided into multiple segmented electrodes (e.g., four segments) that can be independently controlled. This segmentation allows the system to selectively activate only the segments facing the target neural tissue, thereby directing stimulation precisely while avoiding unwanted stimulation of neighboring tissue. The segmented design maintains the circular geometry for uniform current distribution when all segments are activated together.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system dynamically selects and activates specific electrode segments based on the desired stimulation direction. By controlling which segments are active at any given time, the system can steer the current direction dynamically to match the orientation of target neural structures, converting a static uniform radiation pattern into a dynamically controllable directed stimulation system.

Inventive Principle:
Principle #15Dynamics

2Measurement precision

If markers are added to identify circumferential positioning of electrodes, then electrode alignment precision is improved, but the lead structure becomes more complex

Engineering Contradiction:
Improveelectrode positioning accuracyVSAvoidlead structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

Radiopaque markers are incorporated into the lead structure at specific positions corresponding to the segmented electrodes. These markers appear as distinct radiopaque features on fluoroscopic imaging, allowing clinicians to visually identify the circumferential orientation and positioning of electrodes during implantation. The markers provide clear visual cues without requiring complex electronic or mechanical systems.

Inventive Principle:
Principle #32Color changes

Solution Approach 2:

The radiopaque markers serve as intermediary visual indicators that bridge the gap between the internal electrode structure and the external imaging system. During implantation, these markers are visible on fluoroscopic images, enabling the clinician to align the lead's segmented electrodes with the target neural tissue based on visual feedback from the imaging modality.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Manufacturing precision

If segmented electrodes are used for directed stimulation, then stimulation precision is improved, but the electrode configuration becomes more complex

Engineering Contradiction:
Improvestimulation targeting accuracyVSAvoidelectrode configuration complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The electrode ring is divided into multiple independent segmented electrodes that can be individually controlled. This segmentation enables precise targeting of specific neural structures by activating only the segments oriented toward the target, while leaving other segments inactive. The segmented design achieves high stimulation precision while maintaining a relatively simple overall circular geometry.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The segmented electrode configuration provides multiple functions: when all segments are activated together, they function as a complete ring electrode for uniform 360-degree stimulation; when only specific segments are activated, they provide directed stimulation to specific angular regions. This multi-functionality allows the same electrode structure to adapt to different clinical requirements without requiring separate electrode designs.

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

Data Source

PatentEP2806943B1Systems for identifying the circumferential positioning of electrodes of leads for electrical stimulation systems
Publication Date: 2020.11.04 BOSTON SCI NEUROMODULATION CORP
  • EP2806943B1 patent drawingFigure 1
  • EP2806943B1 patent drawingFigure 2A~3B
  • EP2806943B1 patent drawingFigure 4

AI summary

A lead assembly for an electrical stimulation system includes terminals disposed along a proximal end of a lead body and electrodes disposed along a distal end of the lead body. The electrodes include segmented electrodes. At least one distal marker is disposed along the distal end of the lead body. The distal marker identifies the circumferential position of at least one of the segmented electrodes along the lead body. The distal marker is aligned with at least one of the segmented electrodes along the longitudinal length of the lead body. At least one proximal marker is disposed along the proximal end of the lead body. The proximal marker is aligned with the distal marker along the longitudinal length of the lead body. The distal marker and the proximal marker are discontinuous with one another along the lead body.