Bone Tape Stabilization for Complex Fracture Alignment
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Solution Overview
Problem
Current bone stabilization technologies, such as plates and screws, are limited by their invasive nature, dependence on bone density, and inability to visualize fracture lines, leading to high morbidity and re-operation rates in complex craniomaxillofacial injuries and deformities.
Innovation Solution
A flexible, biodegradable ceramic-polymer interpenetrating phase composite 'bone tape' that can be applied directly to the bone, providing initial flexibility for alignment and stabilization, and then rigidized for permanent bonding, allowing for accurate visualization of fracture lines and reduced tissue disruption.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If current fixation technology (plates and screws) is used, then bone stabilization is achieved, but tissue disruption and morbidity increase
Solution Approach 1:
The patent replaces the mechanical screw-plate fixation system with a chemical bonding system. The bone cement provides adhesion through chemical bonding to bone surfaces, eliminating the need for mechanical penetration via screws and plates, thereby reducing tissue disruption and morbidity while maintaining stabilization reliability
Solution Approach 2:
The invention changes the physical and chemical parameters of the fixation interface by using bone cement with specific rheological properties (viscosity, setting time) that allow it to flow into and bond with bone surfaces. The cement's ability to transition from a workable paste to a rigid bonded state provides stabilization without mechanical intrusion
2Reliability
If plates and screws are applied, then bone fragments are stabilized, but bone density requirements limit application sites
Solution Approach 1:
The bone cement provides universal applicability across different bone densities and anatomical sites. Unlike screws that require sufficient bone density for purchase, the cement can bond to various bone surfaces including those with lower density, making the fixation method versatile for different application sites while maintaining reliable stabilization
3Reliability
If hardware fixation is used, then bone stabilization is achieved, but re-operation rates increase due to hardware removal
Solution Approach 1:
The bone cement is designed as a temporary fixation device that is gradually resorbed and discarded by the body as healing progresses. This eliminates the need for secondary surgery to remove permanent hardware, reducing re-operation rates while providing reliable stabilization during the critical healing period
4Reliability
If opaque fixation devices are used, then bone stabilization is achieved, but fracture line visualization is prevented
Solution Approach 1:
The bone cement is formulated with optical properties that allow it to be translucent or transparent in its unset and early set states, enabling surgeons to visualize fracture lines and bone anatomy through the material. This facilitates accurate fracture reduction and alignment while the cement provides stabilization, without the obscuring effect of opaque metallic hardware
5Reliability
If rigid fixation devices are applied, then bone fragments are stabilized, but initial alignment flexibility is reduced
Solution Approach 1:
The bone cement exhibits dynamic properties during the fixation process: initially having a workable consistency that allows easy application and alignment adjustment, then transitioning to a rigid bonded state that provides stable fixation. This dynamic transformation enables both ease of operation during alignment and reliable stabilization afterward
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
The bone tape offers a less invasive, more versatile solution for stabilizing complex bone fragments, reducing operative time and morbidity, and enabling robust 3D reconstruction with minimal bone exposure, while being adaptable to various bone contours and densities.
Implementation Method 1
The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond
Data Source
AI summary
The present disclosure discloses a bone stabilization device (also referred to as a bone tape), which includes a composite flexible construct including a rigidifiable biocompatible sheet structure having first and second opposed surfaces. A biocompatible cement is located on the first surface. In use the composite flexible construct is applied to a bone with the cement contacted directly to the bone. The cement is made of a material that, once adhered to the bone, is curable to mechanically and/or ionically bond to the sheet structure and to chemically bond to the bone to achieve a permanent bond. The bone tape allows simultaneous alignment and stabilization of multiple articulated fragments for successful 3D reconstruction of shattered bones. Initial flexibility and translucency provided by the bone tape can facilitate the temporary stabilization and alignment adjustment of multiple fragments, prior to permanent rigid bonding.