Sternal Circumfixation Plate With Self-Locking Fasteners for Bone Healing
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Solution Overview
Problem
Existing sternum fixation devices are costly, time-consuming, and prone to complications such as infection, non-union, and hardware failure, particularly in patients with underlying health issues, and do not adequately address the biomechanical and biological needs of sternum healing.
Innovation Solution
A circumfixation device comprising a thermoplastic polymer plate with zip tie-like fasteners that pass behind the sternum through intercostal spaces, providing stable fixation while allowing micro-motion for healthy bone healing, and can be easily implanted and removed.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If cerclage wire fixation is used to secure the sternum, then the surgical procedure is simple and cost-effective, but the fixation lacks sufficient rigidity and may lead to complications such as infection, nonunion, and hardware failure
Solution Approach 1:
The fixation device is divided into multiple segments: a sternal plate that contacts the sternum surface, multiple fasteners that pass through intercostal spaces, and a circumferential configuration that distributes forces. This segmentation allows the device to achieve both simplicity of application and high fixation reliability by combining multiple simple elements into a robust system.
Solution Approach 2:
The device employs a thermoplastic polymer plate with self-locking fasteners, creating a composite fixation system that combines the advantages of polymer flexibility and mechanical locking. This composite approach provides sufficient rigidity for stable fixation while maintaining ease of surgical application and removal.
2Reliability
If rigid internal fixation is used to provide stable bone alignment, then healing reliability is improved, but the device complexity and surgical time increase
Solution Approach 1:
The device merges multiple functions into a unified circumferential structure: the sternal plate provides alignment, the fasteners provide compression, and the circumferential configuration provides stability. This merging reduces device complexity compared to traditional multi-component RIF systems while maintaining reliable bone alignment through the integrated circumferential design.
Solution Approach 2:
The circumferential fixation device serves multiple functions simultaneously: it aligns bone fragments, compresses the sternum, distributes mechanical loads, and provides stable fixation. This multi-functionality reduces the need for separate components and surgical steps, thereby reducing overall device complexity while maintaining high alignment stability.
3Strength
If multiple fasteners are used to secure the plate to the sternum, then fixation strength is improved, but the surgical time and difficulty of application increase
Solution Approach 1:
The fasteners are designed with self-locking mechanisms that automatically secure the plate to the sternum without requiring additional tools or complex tightening procedures. This self-service feature maintains high fixation strength through multiple fasteners while significantly reducing surgical time and application difficulty compared to traditional screw-and-nut systems.
Solution Approach 2:
The device changes the mechanical parameters of fixation by using self-locking fasteners that provide sufficient holding strength through their locking mechanism rather than through complex threading and tightening. This parameter change allows multiple fasteners to be quickly applied, maintaining high fixation strength while improving surgical efficiency.
4Strength
If traditional fixation devices are used, then they provide mechanical stability, but they may cause stress shielding and interfere with diagnostic imaging
Solution Approach 1:
The device changes the material parameters by using a thermoplastic polymer plate instead of traditional metal plates. This polymer material provides sufficient mechanical stability for sternal fixation while being radiolucent, thereby eliminating interference with diagnostic imaging technologies such as X-rays and CT scans, and reducing stress shielding effects.
Solution Approach 2:
The use of thermoplastic polymer as the plate material creates a composite fixation system that combines adequate mechanical strength with radiolucency. This composite material approach resolves the contradiction by providing the necessary mechanical stability for bone healing while allowing unobstructed diagnostic imaging and reducing stress shielding compared to dense metal implants.
Data Source
AI summary
An apparatus and technique for infernally securing a plurality of bone segments together. The device incorporates a plate-like structure stabilizing the fracture and integrated fasteners to attach straps circumscribing the bone segments.