Cytocompatibility of Polymers for Skin-Contact Applications Produced via Pellet Extrusion.

Area of Science:

• Biomaterials Science
• Medical Device Manufacturing
• Polymer Science

Background:

• Orthoses and prostheses (O&P) are vital for individuals with limb differences.
• Material selection is critical for O&P mechanical integrity and biocompatibility.
• Additive manufacturing, specifically pellet extrusion (PEX), offers advanced customization for O&P.

Purpose of the Study:

• To investigate the biocompatibility of thermoplastic polymers for skin-contact O&P manufactured via PEX.
• To evaluate surface morphology and cytotoxicity of selected materials.

Main Methods:

• Pellet extrusion (PEX) was used to manufacture thermoplastic polymers.
• Surface morphology was analyzed using microscopy.
• Cytotoxicity was assessed using L929 fibroblast cell cultures.

Main Results:

• Surface morphology varied among materials; TPE-70ShA displayed irregularities.
• Most tested polymers exhibited non-toxic responses in cytotoxicity assays.
• TPE-70ShA demonstrated cytotoxic effects, indicating material-specific biocompatibility concerns.

Conclusions:

• Material composition significantly impacts biocompatibility for skin-contact medical devices.
• Adherence to safety and regulatory standards is crucial in O&P material selection and manufacturing.
• Further research is needed on ingredient-specific effects and other biocompatibility factors.