Development of computer assisted orthosis design and manufacturing system for malformed ears

Most cases of malformed ears in neonates can be treated by mounting a suitably shaped orthosis. Our objective was to develop a computer-assisted orthosis design and manufacturing system for the treatment of malformed ears. Also, we aimed to manufacture a first experimental orthosis made of nitinol shape-memory alloy wire. First, the target posttherapeutic auricular shape is input from computed tomography scans, and characteristic points and contours are extracted. The shape of the orthosis is then created by tracing the necessary contours automatically. Finally, the orthosis shape data are projected onto one or more approximate planes and autoconverted into numerical control (NC) data for plate groove processing. The nitinol shape-memory alloy wires are inserted in the groove and the shape is memorized by heat treatment. The shape of the manufactured orthosis can be memorized from the generated NC data within 1.0 mm of error. Stahl's ear in a 9-month-old baby was treated 7 months ago by mounting the orthosis manufactured by the system. The developed system allows the design and manufacture of orthoses made of nitinol shape-memory alloy wire for the treatment of malformed ears.