Heat Sterilization Effects on Polymeric, FDM-Optimized Orthopedic Cutting Guide for Surgical Procedures

J Funct Biomater. 2021 Nov 19;12(4):63. doi: 10.3390/jfb12040063.

Abstract

Improvements in software for image analysis have enabled advances in both medical and engineering industries, including the use of medical analysis tools to recreate internal parts of the human body accurately. A research analysis found that FDM-sourced elements have shown viability for a customized and reliable approach in the orthopedics field. Three-dimensional printing has allowed enhanced accuracy of preoperative planning, leading to reduced surgery times, fewer unnecessary tissue perforations, and fewer healing complications. Furthermore, using custom tools chosen for each procedure has shown the best results. Bone correction-related surgeries require customized cutting guides for a greater outcome. This study aims to assess the biopolymer-based tools for surgical operations and their ability to sustain a regular heat-sterilization cycle without compromising the geometry and fit characteristics for a proper procedure. To achieve this, a DICOM and FDM methodology is proposed for fast prototyping of the cutting guide by means of 3D engineering. A sterilization test was performed on HTPLA, PLA, and nylon polymers. As a result, the unique characteristics within the regular autoclave sterilization process allowed regular supplied PLA to show there were no significant deformations, whilst annealed HTPLA proved this material's capability of sustaining repeated heat cycles due to its crystallization properties. Both of these proved that the sterilization procedures do not compromise the reliability of the part, nor the safety of the procedure. Therefore, prototypes made with a similar process as this proposal could be safely used in actual surgery practices, while nylon performed poorly because of its hygroscopic properties.

Keywords: 3D engineering; FDM; HTPLA; cutting guide; nylon FDM; preoperative planning; sterilization.