Evaluation of Post-Processing on Additive Manufactured Bioresorbable Polymers for Medical Devices

Additive manufacturing (AM) has seen massive growth in the medical device sector and an increase in the clearance of devices. Many challenges still exist in the design, development, and clinical use of AM-fabricated devices, notably the processing, annealing, and sterilization of resorbable polymers. In addition, the use of these materials continues to grow in medical devices and scaffold technologies for tissue engineering and regenerative medicine (TERM). Specifically, this study focused on the scaffold mechanical properties post-processing and throughout a simulated resorption (in vitro) study. Herein, we evaluated three (3) materials that span a range of mechanical properties and degradation rates relating to a range of tissue healing rates and mechanical properties affording the opportunity of biomimetic potentials, Caproprene 100M, Lactoflex 7415, and Lactoprene 100M. These bioresorbable polymers were additively manufactured into scaffold forms of Type V tensile bars to investigate post-processing parameters. A range of heat treatments were then performed after the AM process to induce a range of semicrystalline morphologies, and subsequently, two different sterilization techniques were performed, one based on super critical carbon dioxide and another using electron beam radiation. It was statistically shown that the heat treatment parameters and the sterilization method had statistically significant effects on the scaffold properties of each material. While material differences were responsible for the majority of the mechanical property breadth, techniques utilizing analysis of variance allowed the observation of significant effects and interactions associated with heat treatment, sterilization, and material parameters (alpha = 0.05). The characterization of the sample groups provided insight into the process-structure-property-performance relationships of the resorbable scaffold samples. It was established that the post-processing impacted the scaffold structures, and therefore, sterilization and heat treatment selections should be included within initial design considerations alongside material selection as critical for device development, especially when AM bioresorbable scaffolds for TERM.