Low-Profile DBS Lead Fixation with Rotatable Arms
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Solution Overview
Problem
Current lead fixation devices for deep brain stimulation (DBS) are cumbersome, visibly protrude under the skin, and may be aesthetically bothersome to patients, particularly those with baldness, while also limiting the use of DBS leads.
Innovation Solution
A lead fixation device with minimally invasive, smaller design that can be implanted through a smaller incision, featuring a mounting plate with rotatable arms and a guide channel to secure the DBS lead, ensuring a flush installation with the scalp, reducing visibility and requiring no assembly or removal of stereotactic components.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard lead fixation devices are used to secure DBS leads, then stable and secure fixation is achieved, but visible and palpable protrusions occur under the skin which are bothersome to patients
Solution Approach 1:
The fixation device transitions from a traditional protruding design to a flush-profile design that lies flat against the scalp surface. The mounting plate with arms extends horizontally rather than vertically, changing the dimensional orientation of the fixation structure to eliminate skin protrusion while maintaining anchoring capability through the burr hole.
Solution Approach 2:
The fixation device is divided into functional segments: a mounting plate for skull attachment, rotatable arms for lead engagement, and a low-profile configuration. This segmentation allows each component to perform its specific function while contributing to the overall flush appearance against the scalp.
2Ease of operation
If larger burr holes are drilled for lead implantation, then easier lead insertion is achieved, but larger visible openings and more noticeable fixation devices result
Solution Approach 1:
The lead is nested within the channel formed between the arms, and the arms are nested within the burr hole opening. This nesting arrangement allows the lead to pass through a relatively small burr hole while being protected and guided by the arms, eliminating the need for large openings.
3Reliability
If traditional lead fixation devices are used, then secure lead anchoring is achieved, but the devices are cumbersome and require complex assembly procedures
Solution Approach 1:
The arms are designed to be rotatable rather than fixed, allowing dynamic adjustment during implantation. The arms can rotate from an open position during insertion to a closed position for lead engagement, providing operational flexibility while maintaining structural simplicity.
Data Source
AI summary
A lead fixation device for attaching a deep brain stimulation lead within in a burr hole in a human skull. The lead fixation device may comprise a mounting plate and an insertion collar extending from a lower surface of the mounting plate and configured to be received in within the burr hole in the human skull. The mounting plate may comprise a mounting flange, a first arm and a second arm. The mounting flange and the first arm may comprise a static mounting hole while the second arm may comprise an adjustable mounting hole. The second arm may be movable to an operating position when the second arm is compressed toward the first arm, the inner walls of the first and second arms are substantially parallel, and the mounting screw is tightened within the adjustable mounting hole when the second arm is in the operating position.