Varsavas Sakine Deniz, Michalec Paweł, Khalifa Mohammed, Li Ping, Spintzyk Sebastian
ADMiRE Research Center, Carinthia University of Applied Sciences, Europastraße 4, 9524 Villach, Austria.
Competence Center for Wood Composites and Wood Chemistry, Wood K Plus, Klagenfurter Str. 87-89, 9300 St. Veit an der Glan, Austria.
J Funct Biomater. 2024 Jun 29;15(7):179. doi: 10.3390/jfb15070179.
Orthoses and prostheses (O&P) play crucial roles in assisting individuals with limb deformities or amputations. Proper material selection for these devices is imperative to ensure mechanical robustness and biocompatibility. While traditional manufacturing methods have limitations in terms of customization and reproducibility, additive manufacturing, particularly pellet extrusion (PEX), offers promising advancements. In applications involving direct contact with the skin, it is essential for materials to meet safety standards to prevent skin irritation. Hence, this study investigates the biocompatibility of different thermoplastic polymers intended for skin-contact applications manufactured through PEX. Surface morphology analysis revealed distinct characteristics among materials, with TPE-70ShA exhibiting notable irregularities. Cytotoxicity assessments using L929 fibroblasts indicated non-toxic responses for most materials, except for TPE-70ShA, highlighting the importance of material composition in biocompatibility. Our findings underscore the significance of adhering to safety standards in material selection and manufacturing processes for medical devices. While this study provides valuable insights, further research is warranted to investigate the specific effects of individual ingredients and explore additional parameters influencing material biocompatibility. Overall, healthcare practitioners must prioritize patient safety by meticulously selecting materials and adhering to regulatory standards in O&P manufacturing.
矫形器和假肢在帮助肢体畸形或截肢患者方面发挥着关键作用。为这些装置选择合适的材料对于确保机械强度和生物相容性至关重要。虽然传统制造方法在定制性和可重复性方面存在局限性，但增材制造，尤其是颗粒挤出（PEX），提供了有前景的进展。在涉及与皮肤直接接触的应用中，材料必须符合安全标准以防止皮肤刺激。因此，本研究调查了通过PEX制造的用于皮肤接触应用的不同热塑性聚合物的生物相容性。表面形态分析揭示了材料之间的不同特征，其中TPE - 70ShA表现出明显的不规则性。使用L929成纤维细胞进行的细胞毒性评估表明，除了TPE - 70ShA外，大多数材料均无毒性反应，这突出了材料成分在生物相容性中的重要性。我们的研究结果强调了在医疗器械的材料选择和制造过程中遵守安全标准的重要性。虽然本研究提供了有价值的见解，但仍需进一步研究以调查单个成分的具体影响，并探索影响材料生物相容性的其他参数。总体而言，医疗从业者必须通过精心选择材料并在矫形器和假肢制造中遵守监管标准来优先考虑患者安全。
