Segmented Electrode Array for Deep Brain Stimulation Leads
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Solution Overview
Problem
Current deep brain stimulation leads are prone to failure due to minimal radial selectivity of current, leading to unwanted stimulation of neighboring neural tissue and increased duration for therapeutic effects, with reported lead breakage rates ranging from 6.8-12.4% within 260-390 days, necessitating revision surgery.
Innovation Solution
The development of leads with segmented electrodes, which allow for superior current steering by varying the placement and orientation of electrodes along the lead, enabling more precise targeting of neural tissue and reducing the likelihood of lead breakage through improved manufacturing techniques such as forming pre-electrodes with thin-walled and thick-walled portions and using insulative materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If ring electrodes are used to provide stimulation, then current is introduced along the length of the lead to stimulate target neurons, but radial selectivity of the current is minimal resulting in unwanted stimulation of neighboring neural tissue
Solution Approach 1:
The continuous ring electrode is divided into multiple discrete segments arranged radially around the lead body. Each segment can be independently controlled to provide stimulation, allowing selective activation of specific neural targets while avoiding adjacent tissue. The segments are separated by insulating material to prevent current spread between adjacent segments.
Solution Approach 2:
Different segments of the electrode array are positioned at different radial locations to target specific neural structures. By activating only the segments corresponding to the desired target, the system provides localized stimulation with high radial selectivity, minimizing stimulation of neighboring tissue that would occur with a continuous ring electrode.
2Reliability
If current is introduced along the length of the lead with minimal radial selectivity, then stimulation is provided to target neurons, but the duration of time for the proper therapeutic effect to be obtained is increased
Solution Approach 1:
The segmented electrode array enables rapid and precise targeting of the correct neural structure by selectively activating specific segments. This reduces the time required to achieve therapeutic effect compared to continuous ring electrodes that require longer stimulation durations to overcome non-selective activation of multiple tissue types.
Solution Approach 2:
The system replaces the mechanical trial-and-error approach of adjusting stimulation parameters with continuous electrodes by using electronically controlled segment selection. This allows immediate precise targeting without the time-consuming process of adjusting continuous electrode parameters to achieve selective stimulation.
3Ease of manufacture
If traditional manufacturing methods are used to produce deep brain stimulation leads, then leads are manufactured, but they are unreliable and prone to failure with breakage rates from 6.8-12.4% within 260-390 days
Solution Approach 1:
The lead construction uses modular components including segmented electrodes, modular connectors, and segmented insulation layers. This modular architecture improves reliability by isolating potential failure points and allowing individual component replacement without complete lead replacement. The segmented structure also reduces stress concentration that could lead to breakage.
Solution Approach 2:
The lead employs composite material construction combining biocompatible metals, flexible polymers, and insulating materials in a layered composite structure. This composite design provides both mechanical strength to prevent breakage and electrical insulation to ensure reliable operation, while maintaining flexibility for surgical implantation.
Data Source
AI summary
A method of making a lead for a stimulation device includes forming at least one pre-electrode in the shape of a ring, the at least one pre-electrode comprises at least two thin-walled portions separated by at least two thick-walled portions; disposing the at least one pre-electrode near a distal end of a lead body; joining at least one conductor to each thick-walled portion of the at least one pre-electrode; and grinding the lead body and the at least one pre-electrode to remove the thin-walled portions of the at least one pre-electrode to form segmented electrodes from the thick-walled portions of the at least one pre-electrode.