Theoretical a and e experimental b basis ffor tthe development o of a a d dynamic a airway s stent

Three major problems are currently associated with airway stents: mucostasis, formation of granulation tissue, and migration. We wanted to deter- mine whether these problems could be solved by a different stent design. Based on theoretical considerations of an idealized trachea, we developed a dyna- mic bifurcation stent made of silicone which incorporates horseshoe-shaped steel struts. A flexible posterior membrane enables dynamic compression during cough, whilst the clasps maintain the airway lumen in the face of external compression. The design of the stent cast was based upon computed tomographic (CT)-scan stu- dies of the central airways. Its complex shape provides a smoother distribution of pressure on the mucosa; thereby, lowering the stimulus for granulation formation. The bronchial limbs saddle on the carina, preventing displacement. The mechanical behaviours of the new stent and two commercially available stents were compared in an ex-vivo model, utilizing freshly excised tracheae and new visu- alization techniques. Dynamic (artificial coughs) and static loads (simulating tumour compression or pleural pressures) were applied on excised human tracheae with different stents. Our dynamic stent preserved effective compression of the poste- rior membrane in response to cough, and also provided lumen stability against extrinsic compression. In comparison, the two commercially available stents did not provide both functions equally well. In conclusion, our newly designed dynamic bifurcation stent shows characteris- tics which should prove useful in avoiding problems currently associated with air- way stents.