Patient-Specific Fixation Plate with Contoured Spacing Elements
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Solution Overview
Problem
Existing tools and procedures for knee osteotomies, such as high tibial osteotomies, lack accuracy and precision in correcting the alignment of the knee joint, necessitating improved methods for securing fixation plates to bones.
Innovation Solution
A patient-specific fixation plate kit is developed, including a fixation plate and spacing elements with bone interface sides that conform to the contours of the bone, allowing for precise positioning and spacing to enhance the accuracy of bone alignment during osteotomy procedures. The kit includes a method for designing and manufacturing custom spacing elements using 3D models of patient bones to ensure optimal fit and support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a standard fixation plate is used without customization, then the device complexity is reduced and ease of manufacture is improved, but the manufacturing precision and measurement precision of bone alignment are insufficient
Solution Approach 1:
The bone interface side of the fixation plate is pre-contoured during manufacturing to match the specific anatomy of the patient's bone. This preliminary shaping action eliminates the need for intraoperative customization while achieving high alignment precision, as the plate is designed beforehand based on preoperative planning.
Solution Approach 2:
The fixation plate creates a precise copy or replica of the patient's bone surface geometry through the contoured bone interface side. This copying approach allows the plate to conform exactly to the individual bone contours, achieving high manufacturing precision without requiring complex customization procedures during surgery.
2Measurement precision
If a fixation plate with contoured bone interface side is used, then the measurement precision and alignment accuracy are improved, but the ease of operation during surgery is reduced due to custom positioning requirements
Solution Approach 1:
The optimal positioning and contouring of the fixation plate are determined through preoperative planning. This preliminary action transfers the complexity from the surgical procedure to the preoperative design phase, allowing the surgeon to simply install the pre-positioned plate without complex intraoperative adjustments.
Solution Approach 2:
The contoured bone interface side enables the fixation plate to self-align with the bone surface through its pre-designed geometry. The plate's own shape serves as the positioning mechanism, eliminating the need for complex external alignment tools or procedures during surgery.
3Manufacturing precision
If spacing elements with bone-contacting surfaces are added to the fixation plate, then the manufacturing precision of plate positioning is improved, but the device complexity and number of components increase
Solution Approach 1:
The spacing elements and fixation plate are merged into a single integrated component. The contoured bone interface side combines the functions of both the fixation plate body and the spacing elements, eliminating separate components while maintaining precise positioning accuracy through the unified contoured surface.
Solution Approach 2:
The contoured bone interface side serves multiple functions simultaneously: it provides the fixation plate's structural body, creates precise spacing from the bone surface, and enables accurate positioning. This multi-functionality reduces the need for separate spacing elements while maintaining manufacturing precision.
Data Source
AI summary
According to an aspect, a spacing element for spacing a fixation plate away from a bone to which the fixation plate is secured is provided. The spacing element has a body with a bone interface side and a plate interface side and sidewalls extending thereinbetween, said bone interface side having a bone contacting surface having contours conforming to surface contours of the bone. A corresponding fixation plate, fixation plate kit, and method for designing a patient-specific spacing element are also provided.