Helical Multi-Lumen DBS Lead for Precise Neural Stimulation

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Solution Overview

Problem

Deep brain stimulation leads with ring-shaped electrodes face challenges in directing electrical stimulation specifically to target neurons, leading to unwanted stimulation of neighboring neural tissue and potential side effects due to undirected current distribution.

Innovation Solution

A deep brain stimulation lead with a multi-lumen conductor guide that forms helical sections around a central stylet lumen, allowing for the placement of electrodes and conductors in a configuration that enhances flexibility and strain relief, enabling more precise targeting of neural tissue by adjusting the pitch and arrangement of conductor lumens.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ring-shaped electrodes are used on the lead, then electrical stimulation can be delivered to target neurons, but the stimulus current projects equally in every direction causing unwanted stimulation of neighboring neural tissue

Engineering Contradiction:

Improveprecision of neural stimulationVSAvoidunwanted stimulation of neighboring neural tissue

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent segments the ring-shaped electrode into multiple discrete contact points or segments around the lead. This segmentation allows independent control of each segment, enabling directional steering of the stimulus current. By activating only specific segments rather than the entire ring, the current is directed toward target neurons while minimizing spread to neighboring tissue, thus resolving the contradiction between achieving reliable stimulation and avoiding harmful side effects.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by creating non-uniform current distribution through selective activation of electrode segments. Different segments can be activated with different intensities or patterns to create localized stimulation zones. This allows the stimulus current to be concentrated on specific sides or points around the lead rather than projecting equally in all directions, thereby improving precision while reducing unwanted stimulation of adjacent neural tissue.

Inventive Principle:

Principle #3Local quality

2Ease of operation

If the lead is made flexible to accommodate brain curvature, then the lead can conform to neural structures, but bending the lead may cause unintended deflections that affect electrode positioning

Engineering Contradiction:

Improveflexibility of the leadVSAvoidelectrode positioning accuracy

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

The patent applies preliminary action by pre-shaping the lead into a curved configuration that matches the expected anatomy of the brain or implantation site. The lead is formed with predetermined bends or curves during manufacturing so that when implanted, it naturally conforms to the target neural structures without requiring post-implantation manipulation. This pre-shaping ensures that the electrodes are positioned accurately from the start, eliminating the risk of unintended deflections that would occur if the lead were bent after implantation.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patent utilizes curvature by designing the lead with a curved or arc-shaped structure rather than a straight configuration. This curved geometry allows the lead to follow the natural contours of brain structures or implantation pathways. The curvature is carefully engineered to match anatomical features, enabling the lead to conform to neural structures while maintaining stable electrode positioning. The curved design distributes mechanical stresses along the lead's length, preventing sharp bends that could cause unintended deflections or positioning errors.

Inventive Principle:

Principle #14Spheroidality (Curvature)

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

The solution improves the precision of electrical stimulation by reducing unwanted side effects and enhancing the flexibility of the lead, allowing for more targeted neural stimulation without causing unintended deflections during bending, thus improving the efficacy of deep brain stimulation treatments.

Implementation Method 1

The multi-lumen conductor guide is twisted to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the stylet lumen

Methodology Applied

Scientific EffectHelical structure formation: Helix

Implementation Method 2

heat is applied to the multi-lumen conductor guide to set the at least one helical section

Methodology Applied

Scientific EffectHeat treatment: Heat Treatment

Data Source

PatentUSRE48907E1Systems and methods for making and using improved leads for electrical stimulation systems

Publication Date: 2022.02.01 BOSTON SCI NEUROMODULATION CORP

AI summary

A method for manufacturing a lead includes forming an elongated multi-lumen conductor guide defining a central stylet lumen and a plurality of conductor lumens arranged around the stylet lumen. The multi-lumen conductor guide is twisted to form at least one helical section where the plurality of conductor lumens each forms a helical pathway around the stylet lumen. Each of the helical pathways of the at least one helical section has a pitch that is no less than 0.04 turns per centimeter.