Studies and applications of NiTi shape memory alloys in the medical field in China.

The biomedical study of NiTi shape memory alloys has been undertaken in China since 1978. A series of stimulating corrosion tests, histological observations, toxicity tests, carcinogenicity tests, trace nickel elements analysis and a number of clinical trials have been conducted. The results showed that the NiTi shape memory alloy is a good biomaterial with good biocompatibility and no obvious local tissue reaction, carcinogenesis or erosion of implants were found experimentally or clinically. In 1981, on the basis of fundamental studies, a shape memory staple was used for the first time inside the human body. Subsequently, various shape memory devices were designed and applied clinically for internal fixation of fractures, spine surgery, endoprostheses, gynaecological and craniofacial surgery. Since 1990, a series of internal stents have been developed for the management of biliary, tracheal and esophageal strictures and urethrostenosis as well as vascular obturator for tumour management. Several thousand cases have been treated and had a 1-10 year follow-up and good clinical results with a rather low complication rate were obtained.