Process Parameters Optimization and Mechanical Properties of Additively Manufactured Ankle-Foot Orthoses Based on Polypropylene.

Nowadays, Fused Filament Fabrication (FFF) 3D printing offers promising opportunities for the customized manufacturing of ankle-foot orthoses (AFOs) targeted towards rehabilitation purposes. Polypropylene (PP) represents an ideal candidate in orthotic applications due to its light weight and superior mechanical properties, offering an excellent balance between flexibility, chemical resistance, biocompatibility, and long-term durability. However, Additive Manufacturing (AM) of AFOs based on PP remains a major challenge due to its limited bed adhesion and high shrinkage, especially for making large parts such as AFOs. The primary innovation of the present study lies in the optimization of FFF 3D printing parameters for the fabrication of functional, patient-specific orthoses using PP, a material still underutilized in the AM of medical devices. Firstly, a thorough thermomechanical characterization was conducted, allowing the implementation of a (thermo-)elastic material model for the used PP filament. Thereafter, a Taguchi design of experiments (DOE) was established to study the influence of several printing parameters (extrusion temperature, printing speed, layer thickness, infill density, infill pattern, and part orientation) on the mechanical properties of 3D-printed specimens. Three-point bending tests were conducted to evaluate the strength and stiffness of the samples, while additional tensile tests were performed on the 3D-printed orthoses using a home-made innovative device to validate the optimal configurations. The results showed that the maximum flexural modulus of 3D-printed specimens was achieved when the printing speed was around 50 mm/s. The most significant parameter for mechanical performance and reduction in printing time was shown to be infill density, contributing 73.2% to maximum stress and 75.2% to Interlaminar Shear Strength (ILSS). Finally, the applicability of the finite element method (FEM) to simulate the FFF process-induced deflections, part distortion (warpage), and residual stresses in 3D-printed orthoses was investigated using a numerical simulation tool (Digimat-AM^®). The combination of Taguchi DOE with Digimat-AM for polypropylene AFOs highlighted that the 90° orientation appeared to be the most suitable configuration, as it minimizes deformation and von Mises stress, ensuring improved quality and robustness of the printed orthoses. The findings from this study contribute by providing a reliable method for printing PP parts with improved mechanical performance, thereby opening new opportunities for its use in medical-grade additive manufacturing.