Flexible Bone-Flap Affixation Plate for Thin Pediatric Skulls
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Solution Overview
Problem
The replacement of surgically removed skull portions in young children is difficult due to the low tensile strength of their skulls and the irregular shape of the posterior fossa, leading to high failure rates with commercially-available plates and screws.
Innovation Solution
An affixation device with a customizable base plate and spacers, featuring a concave shape to match the skull, flexible lines for adaptation, and tapered spacers to secure the bone flap, which can be tailored to individual patient anatomy using materials like resorbable polymers and ceramics.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If commercially-available plates and screws are used to secure the bone flap, then the procedure can be performed with standard equipment, but the securement fails at high rates due to low tensile strength of young children's skulls
Solution Approach 1:
The invention changes the physical parameters of the affixation device by using a thin, flexible sheet material that can conform to the irregular skull surface. The device includes flex lines that allow bending and adaptation to the curved bone surface, enabling secure attachment even on thin skulls with tensile strength only 2-3 mm thick. This parameter change from rigid to flexible morphology resolves the contradiction between securement reliability and skull strength limitations.
Solution Approach 2:
The affixation device is constructed as a thin, flexible sheet with flex lines that enable it to bend and conform to the irregular shape of the posterior fossa and skull surface. This flexible film structure can adapt to the curved geometry of young children's skulls without requiring high insertion forces, thereby achieving reliable securement despite low skull tensile strength.
2Ease of manufacture
If standard metal strips or plates are used for affixation, then the device structure is simple and readily available, but they are difficult to secure to the child's skull due to the irregular shape of the posterior fossa
Solution Approach 1:
The device uses a flexible thin film structure with integrated flex lines that allow the sheet to bend and conform to the irregular posterior fossa geometry. This flexible morphology enables the same standardized device to adapt to varying anatomical shapes across different patients, resolving the contradiction between ease of manufacture and anatomical adaptability.
Solution Approach 2:
The affixation device incorporates dynamic flexibility through flex lines that allow the structure to adapt its shape during installation. The device transitions from a flat manufactured state to a conformed state that matches the irregular skull surface, enabling versatile adaptation to different anatomical configurations while maintaining manufacturing simplicity.
3Stability of the object's composition
If the affixation device is made rigid to provide structural support, then it maintains structural integrity, but it cannot adapt to the unique skull shape and size of each patient
Solution Approach 1:
The device employs flex lines that create dynamic regions capable of bending and conforming to patient-specific anatomy. These flexible zones allow the device to adapt to unique skull shapes and sizes while the surrounding rigid areas maintain structural integrity and provide stable attachment points for screws or other fastening mechanisms.
Solution Approach 2:
The affixation device features localized flexibility at specific flex line positions while maintaining rigidity in other areas. This local quality differentiation allows the device to conform to irregular skull surfaces where adaptation is needed, while preserving structural integrity in regions requiring stability for securement. The base plate may include rigid zones for attachment and flexible zones for conforming to the skull curvature.
Data Source
AI summary
An affixation device for a human skull may include a base plate that has an outer area for securing to the skull and an inner area for securing to a bone flap removed from the skull. The affixation device may also have at least one spacer located between the outer area and the inner area, where the at least one spacer extends from a first surface of the base plate, where the first surface facing the skull when the fixation device is in an installed state, and where the at least one spacer is configured to extend between the bone flap and the skull in the installed state.