Titanium Shelf Clip for Craniotomy Bone Flap Stabilization
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Solution Overview
Problem
Current methods for stabilizing and securing bone flaps in craniotomy procedures are time-consuming and inefficient, often requiring multiple screws and additional bone removal for re-access, and do not effectively fill the kerf gap or promote bone growth.
Innovation Solution
An implantable bone support system using titanium shelf clips that can be attached around the skull opening to create a stable interior shelf for the bone flap or implant, eliminating the need for screws and allowing for easy removal and re-access, with adjustable components to accommodate varying skull thickness and bone shapes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If plates and bone screws are used to stabilize bone segments, then the bone flap is securely fixed to the skull, but the surgical time is significantly increased due to the time-consuming process of placing multiple screws
Solution Approach 1:
The fixation system is divided into modular components: a plate structure with multiple screw holes positioned at optimal locations, allowing sequential rather than simultaneous screw placement. This segmentation enables the surgeon to place screws one at a time in a systematic manner, reducing the overall time required while maintaining stable fixation.
Solution Approach 2:
The plate is pre-formed with precisely positioned screw holes and contours that match the skull and bone flap geometry. This preliminary preparation eliminates the need for intraoperative measurement and adjustment, allowing the plate to be quickly positioned and secured with minimal surgical time while ensuring reliable stabilization.
2Strength
If multiple screws are used to secure plates to bone surfaces, then the bone segments are strongly attached, but additional bone removal is required to make screws flush with the skull to avoid adhesions
Solution Approach 1:
The plate is designed with variable thickness and contoured surfaces that adapt to the local anatomy of the skull and bone flap. The plate thickness varies to accommodate different bone depths, and the undersurface is contoured to match the skull curvature. This allows screws to be positioned optimally without requiring extensive bone removal, maintaining strong attachment while minimizing additional bone loss and preventing adhesion formation.
3Reliability
If bone screws and plates are used for fixation, then the bone flap is stabilized, but the screws cannot be easily removed for re-access to the brain cavity requiring additional bone removal
Solution Approach 1:
The fixation system is designed to be dynamically adjustable and reversible. The plate contains multiple screw holes that allow for reconfiguration of screw positions and depths. Screws can be selectively removed or loosened to facilitate re-access to the brain cavity, and the plate itself can be repositioned if needed. This dynamic design enables easy modification for repeat surgeries without requiring additional bone removal, while maintaining reliable stabilization during the initial healing period.
4Stability of the object's composition
If the bone flap is abutted against the skull opening to encourage bone growth, then bone to bone contact surface is increased, but the joint becomes brittle and the bone flap may not remain in position
Solution Approach 1:
The plate serves as an intermediary device between the bone flap and the skull. It provides mechanical support and stabilization while allowing controlled bone-to-bone contact at specific sites to promote natural bone growth. The plate distributes loads across multiple attachment points, preventing the brittleness and positioning failures that occur with direct abutment, while still facilitating osteogenesis where needed.
Data Source
AI summary
An implantable bone support system including a shelf clip supported on a portion of the perimeter of the skull opening. The shelf clip includes upper and lower body portions. The legs of the lower body portion are positioned such that one leg is engaged with the skull perimeter in a direction away from the skull opening. The opposing leg is positioned into the skull opening to form a portion of a shelf for receiving the bone flap or implant. In an adjustable height embodiment, the ratcheting leg of the upper body portion engages a central post, via ratchet teeth on the leg and the central post, and is pressed into engagement to capture the skull between the upper and lower body portions. The removable or locking leg is formed for engagement with the upper body portion of the clip, and engages an external surface of the bone flap or implant to capture the bone flap or implant within the shelf created by the clips within the skull opening.