Low-Profile DBS Lead Fixation Device for Scalp Integration
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Solution Overview
Problem
Current lead fixation devices for Deep Brain Stimulation (DBS) are cumbersome, visible, and palpable under the skin, causing discomfort and aesthetic concerns, especially for bald patients, and require larger bone openings for installation.
Innovation Solution
A minimally invasive, smaller lead fixation device made of biocompatible materials like PEEK, designed for placement through a smaller bone opening, with a compact design that secures the DBS lead without assembly or removal of stereotactic equipment, and is designed to be flush with the scalp for reduced visibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If standard lead fixation devices are used, then secure fixation of DBS leads is achieved, but visible and palpable protrusion under the skin occurs causing discomfort and aesthetic concerns
Solution Approach 1:
The fixation device utilizes a thin, flexible profile that conforms to the scalp surface, eliminating the traditional bulky protruding structure. The device incorporates a low-profile design with smooth contours that minimize visibility and palpability under the skin while maintaining adequate fixation strength through distributed attachment points and conformal contact with the skull surface.
Solution Approach 2:
The invention changes the geometric parameters of the fixation device, specifically reducing its height and profile depth to create a low-profile configuration. This parameter modification allows the device to sit flush or nearly flush with the scalp surface, eliminating the harmful protrusion effect while preserving the fixation function through optimized anchor point distribution and attachment mechanics.
2Reliability
If standard lead fixation devices are used, then stable and secure fit against the skull is achieved, but larger bone openings are required for installation
Solution Approach 1:
The fixation device is segmented into multiple functional components including separate anchoring elements, a central body, and closure mechanisms that can be assembled through a small opening. This segmentation allows the individual components to pass through a minimized bone opening and then assemble into the complete fixation structure on the other side, eliminating the need for a large single-piece insertion opening.
Solution Approach 2:
The device incorporates nested components where smaller elements are contained within or can be inserted through the central body structure. The anchoring elements and fixation components are designed to nest together through a compact configuration that passes through a small bone opening, then expand or lock into place to provide stable fixation.
3Reliability
If standard lead fixation devices are used, then lead anchoring is achieved, but cumbersome installation procedure requiring stereotactic equipment assembly and removal occurs
Solution Approach 1:
The fixation device incorporates self-aligning and self-securing features that eliminate the need for complex stereotactic equipment assembly and removal procedures. The device includes integrated alignment guides, self-locking mechanisms, and snap-fit connections that automatically position and secure the lead during a simplified installation process, reducing procedural complexity while maintaining reliable anchoring.
Solution Approach 2:
The device includes pre-configured anchoring elements and pre-formed geometric structures that are prepared in advance during manufacturing. These preliminary configurations include pre-bent anchoring tabs, pre-positioned fixation points, and pre-assembled component sets that eliminate the need for complex intraoperative assembly procedures, allowing for rapid and simple installation through a standardized process.
Data Source
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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 having first and second arms. The first arm may comprise a first flange, a first mounting hole, and a first inner wall. The second arm may comprise a second flange, a second mounting hole, and a second inner wall. The first and second arms may comprise first and second arcuate grooves located on the first and second inner walls. When the lead device is in a closed position the first and second arcuate grooves form a guide channel and the first and second inner walls form an exit channel to receive the lead when the lead fixation device is in a closed position.