A new thermal shape memory Ti-Ni alloy stent covered with silicone.

An attempt was made to develop an airway stent for nonsurgical transluminal implantation using a bronchofiberscope. The stent is composed of a single wire with a diameter of 0.5 mm. The wire is made of thermal shape memory titanium nickel alloy, with a transition temperature of 25-30 degrees C. To avoid direct contact between the metal and the tissue, the wire is covered with a 300 microns thick coating of silicone. The stent is horseshoe shaped in cross-section. It is 15 mm in outer transverse diameter and 40 mm long. Ten stents were implanted in 10 dogs whose tracheal cartilages had been previously broken. The stents were first cooled in ice water to reduce their diameter and then inserted into the target site. The wire was warmed to body temperature and recovered its initial shape within 10 sec. The dogs were killed for examination between 1 week and 6 months after implantation. All the stents were located at the implantation sites and were patent. Tissue reactions, such as ulceration and granulation formation, were less severe than in those with previously implanted non-silicone covered stents. Microscopic observation showed that the wires became gradually covered with epithelium within 2 months. This transluminal technique for preserving airway patency shows promise for clinical application.