Deployable Electrode Array Lead for Deep Brain Stimulation
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Solution Overview
Problem
Current deep brain stimulation (DBS) lead assemblies lack sufficient lateral field steering capabilities, limiting the precision of neural tissue stimulation and requiring patients to remain conscious during implantation procedures to avoid damaging brain tissue, as existing deployable leads do not provide safe and easy implantation and explantation configurations.
Innovation Solution
A lead assembly with a central lead member and side lead members that deploy in a non-linear, constant-radius arc configuration, allowing for improved lateral field steering and safe implantation and removal without significant tissue damage, facilitated by a cannula and buckler mechanism for controlled deployment and extraction.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If additional electrodes are added lateral to the anatomical target using prior art deployable leads, then lateral field steering capability is improved, but the risk of simultaneously removing significant brain tissue during explantation increases
Solution Approach 1:
The side lead members are configured to extend along a constant-radius arc when deployed, forming a curved electrode array geometry. This arc configuration allows the electrodes to be distributed laterally around the anatomical target while maintaining a controlled angular spread. The curvature enables improved lateral field steering capability while limiting the maximum lateral deviation from the longitudinal axis, which facilitates safer explantation by reducing the risk of simultaneously removing significant brain tissue.
2Device complexity
If a single DBS lead with segmented electrodes is used, then lead simplicity is maintained, but lateral field steering capability is limited to less than about 1 mm
Solution Approach 1:
The lead assembly is divided into a central lead member and multiple side lead members, with each side lead member containing one or more electrodes. This segmentation allows the electrodes to be distributed across multiple spatial locations, enabling lateral field steering capability greater than 1 mm while maintaining relatively simple individual lead member structures. Each side lead member can be independently positioned along a constant-radius arc to achieve the desired electrode array geometry.
3Adaptability or versatility
If deployable lead system is used to add lateral electrodes, then lateral field steering is improved, but lead management complexity for implanting surgeons increases
Solution Approach 1:
The side lead members are configured to be disposed around the central lead member in a nested arrangement when in the deployed position. This nested configuration allows the multiple lead members to be managed as a unified assembly during implantation, with the side lead members naturally positioned relative to the central lead member. The constant-radius arc geometry provides a predictable and visualizable electrode array configuration that simplifies lead management for implanting surgeons while still achieving improved lateral field steering.
Data Source
AI summary
A lead assembly includes a central lead member having a distal portion configured to extend along a longitudinal axis. The lead assembly also includes two or more side lead members disposed around the central lead member. Each side lead member includes a deploying portion extending at an angle away from the longitudinal axis. Each deploying portion has a proximal portion and a distal portion. The distal portion is laterally spaced from the central lead member and extends more parallel to the longitudinal axis than the proximal portion. The lead assembly also includes one or more electrodes attached to the distal portion of the deploying portion of each side lead member. The lead assembly optionally includes a cannula comprising a lumen, an end portion, and a buckler disposed in the lumen on the end portion for deploying the lead members.