A shape memory airway stent for tracheobronchomalacia in children: an experimental and clinical study.

The authors have designed a coil airway stent using a thermal shape-memory titanium-nickel alloy (SMA) to relieve airway collapse in children. A characteristic of alloy allowed the stent to be enclosed in the thin introducer tube and to position it bronchoscopically in the collapsed airway. When the stent is warmed to 37 to 40 degrees C, it expands to the memorized diameter and stents the airway. In eight rabbits, an experimental model of potentially fatal tracheomalacia was created by fracturing the tracheal cartilages. The stents of 6 mm in diameter and 15 mm in length were placed, and then the stents were recovered to their original shape within 1 minute. All rabbits except one showed no respiratory symptoms during the follow-up period. Results of bronchoscopy performed 6 and 10 months after implantation showed satisfactory patency of the trachea. The rabbits were killed for histological evaluation 6 to 28 months after implantation. The specimens showed little proliferation of granulation and no dislodgement of the stents. This procedure was attempted in two children who had severe bronchomalacia. One 5-year-old patient underwent implantation with a stent of 5 mm in diameter and 25 mm in length into the left main bronchus. The patient was relieved from apneic attacks. The stent was removed 2 years after implantation after a remarkable improvement of ventilation. The other patient with left bronchomalacia, age 1 year 2 months, underwent implantation with a 5-mm x 20-mm stent. The animal experiment and clinical experience indicated that (1) this stent can be easily inserted and removed bronchoscopically, (2) the stent has good tissue compatibility and little interference of mucociliary function, and (3) the SMA stent is a promising therapeutic adjunct in the management of children with severe tracheobronchomalacia.