Properties of shape memory polyurethane used as a low-temperature thermoplastic biomedical orthotic material: influence of hard segment content.

A series of PCL-based shape memory polyurethanes was synthesized via bulk pre-polymerization. Their thermal, mechanical properties, shape memory properties, softening and hardening processes were investigated by the experimental approach and made comparison with a commercially available orthotic material. The cytotoxicity of the low-temperature thermoplastic polyurethane was tested. The results suggest that the soft segment phase of the shape memory polyurethanes has a melting transition at about 36-46 degrees C, which makes them possible low-temperature thermoplastic materials. The hard segment phase has a two-fold effect on the shape memory polyurethane as a low-temperature thermoplastic orthotic material: increasing tensile mechanical strength at room temperature, which enables it to be used in circumstances where high tensile strength is required; and reducing low-temperature malleability and fixity ratio, which make it difficult to fabricate orthotic devices. To obtain a shape memory polyurethane with excellent low-temperature thermoplastic properties for orthopaedical surgical use, the hard segment content should not be above 22 wt%. At last, a prototype wrist orthosis was easily fabricated at 60 degrees C with hand using a shape memory polyurethane with 16 wt% hard segment content. Cytotoxicity tests indicate that the wrist orthotic material is not cytotoxic.