3D Bone Remodeling with Nitinol Shape Memory Mesh
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Solution Overview
Problem
Current bone distraction techniques are limited to single-dimensional lengthening, lacking precision and a predetermined endpoint, which complicates the reconstruction of complex bone structures and often require bone fragments from other sites for reshaping.
Innovation Solution
A device utilizing a continuous nitinol sheet, mesh, or web arranged in a predetermined 3-dimensional conformation that utilizes shape memory properties to distract and reshape bones in three dimensions, allowing for precise remodeling by returning to its pre-programmed shape upon temperature stimulus.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If traditional external adjustable frameworks or simple nitinol springs are used for bone distraction, then bone lengthening can be achieved, but the distraction is limited to single direction and lacks precision for complex 3D reshaping
Solution Approach 1:
The patent transitions from traditional 1D linear distraction devices to a 3D conformable mesh structure. The mesh can be shaped into complex three-dimensional configurations that match the target bone geometry, enabling distraction and reshaping in multiple directions simultaneously rather than along a single axis.
Solution Approach 2:
The patent utilizes phase transition of nitinol material between martensite (soft, formable) and austenite (rigid, shape-retaining) states. By controlling temperature-induced phase changes, the device can be easily formed into complex 3D shapes during manufacturing, then maintain those precise shapes during implantation and distraction operation.
2Manufacturing precision
If complex distractor designs are developed to achieve better bone remodeling, then reshaping capability improves, but device complexity and surgical risk increase
Solution Approach 1:
The patent employs a thin mesh structure made of nitinol that can be conformably shaped to match complex bone surfaces. This flexible yet formable mesh provides precise 3D geometry control without requiring complex mechanical assemblies, reducing device complexity while maintaining high shaping precision.
Solution Approach 2:
The patent uses nitinol, a composite alloy of nickel and titanium, which combines shape memory effect with superelasticity. This material property combination allows the device to be formed into precise complex shapes while maintaining mechanical flexibility and biocompatibility, avoiding the need for even more complex design solutions.
3Reliability
If conventional distraction methods are used, then bone lengthening occurs, but there is no predetermined endpoint and outcomes remain unpredictable
Solution Approach 1:
The patent incorporates predetermined shape memory configurations into the mesh device before implantation. The desired final bone geometry is pre-programmed into the mesh structure, which then guides the distraction process toward a known endpoint. This eliminates the uncertainty of conventional methods where the final outcome was not predetermined.
4Ease of manufacture
If simple nitinol wires or springs are used for distraction, then the device is easy to manufacture, but the device cannot provide controlled 3D bone remodeling
Solution Approach 1:
The patent uses a thin nitinol mesh that can be relatively simply manufactured and then formed into complex 3D shapes through conventional forming techniques. The mesh structure itself is simple to produce, but its ability to be shaped into three-dimensional configurations provides advanced bone remodeling capability that simple wires or springs cannot achieve.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables precise 3D bone reshaping and growth direction, improving the accuracy and predictability of bone reconstruction, reducing complications and the need for external bone fragments, while providing controlled modulation of bone morphology.
Implementation Method 1
a shape memory material which is nitinol and is a continuous sheet, mesh or web, and wherein the shape memory material is arranged into a predetermined three-dimensional conformation in the austenitic phase of nitinol which corresponds to the desired shape of the bone to be distracted
Data Source
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AI summary
The present invention relates to a device for modulating biological tissue and/or bone conformation, the device comprising a shape memory material and being capable of modulating biological tissue and/or bone conformation simultaneously in at least 2 dimensions, a process for producing the device, a process for modulating biological tissue and/or bone using the device, and uses thereof.