Deep Brain Stimulation Lead with Pre-Formed Conductor Relief
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Solution Overview
Problem
Existing electrical stimulation leads for deep brain stimulation lack flexibility and strain relief, leading to unwanted stimulation of neighboring neural tissue due to undirected current distribution from ring-shaped electrodes, resulting in potential side effects.
Innovation Solution
The development of electrical stimulation leads with pre-formed relief sections along conductors, strain relief cavities, and multi-lumen conductor guides to enhance flexibility and direct current distribution, reducing unwanted stimulation by allowing for precise alignment of stimulation electrodes with target neurons.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If ring-shaped electrodes are used for deep brain stimulation, then electrical current can be delivered to target neurons, but the current cannot be directed to specific positions around the electrode, resulting in unwanted stimulation of neighboring neural tissue
Solution Approach 1:
The ring electrode is divided into multiple discrete electrode contacts positioned at different angular locations around the lead. This segmentation allows selective activation of specific electrode contacts to direct current to particular spatial positions, enabling precise targeting of neurons while avoiding stimulation of unwanted neighboring tissue.
Solution Approach 2:
Different electrode contacts are positioned at specific angular locations to provide locally optimized current delivery. Each electrode contact targets a specific directional region, allowing the system to deliver current with spatially varying properties - directing current precisely where needed while minimizing current in directions that would stimulate unwanted tissue.
2Reliability
If the lead is made rigid to maintain electrode positioning, then stable stimulation can be provided, but the lead lacks flexibility and cannot accommodate patient movement, leading to strain and potential lead failure
Solution Approach 1:
The lead incorporates a flexible section with relief features that allow dynamic movement and bending without compromising the electrical connection or electrode positioning. The relief section enables the lead to adapt to patient movement and implantation site variations while maintaining the functional integrity of the electrode-array and electrical contacts.
Solution Approach 2:
The lead includes a relief section with increased flexibility positioned to absorb mechanical strain before it reaches critical components. This pre-positioned flexible section acts as a cushion that accommodates bending and movement, protecting the electrode-array and electrical connections from damage due to patient movement or implantation stresses.
3Ease of manufacture
If the conductor is made straight and rigid for easy manufacturing, then production is simplified, but the conductor cannot accommodate bending and strain, leading to conductor failure and lead malfunction
Solution Approach 1:
The conductor includes a relief section with altered geometry (such as a bent, coiled, or zigzag configuration) that provides flexibility and strain accommodation. This dynamic section allows the conductor to bend and deform elastically in response to lead movement without breaking, while the remaining straight portions maintain electrical connectivity and can be easily manufactured using standard techniques.
Data Source
AI summary
A method for manufacturing a lead includes pre-forming at least one relief section along a length of an elongated conductor having a first end and an opposing second end. The conductor with the pre-formed relief section is inserted into a conductor lumen defined along a length of an elongated lead body. The lead body has a first end and an opposing second end. An electrode is disposed at the first end of the lead body. The first end of the conductor is electrically coupled to the electrode. A terminal is disposed at the second end of the lead body. The second end of the conductor is electrically coupled to the terminal.