Project Description:
Nearly 100,000 tracheostomies are performed in the United States each year. While this remains an effective method for establishing an alternative airway, patient safety and procedural efficiency continue to be concerns due to the time-consuming, multi-step procedure required by the current standard of care - the Ciaglia Blue Rhino system. Our solution aims to streamline the procedure for surgeons and improve patient outcomes by minimizing procedural complexity, apnea duration, infection risk, damage to the tracheal wall, and tracheal ring fracture. The design features non-compliant concentric balloons over a multi-lumen catheter, enabling controlled, single step, radial dilation. Each balloon inflates independently via separate lumens and stopcock controlled syringes, allowing stepwise expansion with a single insertion. Performance evaluation was conducted through benchtop testing on ex vivo chicken breast tissue, where our prototype successfully created radial deformation and dilation of the artificial tissue, supporting the design’s feasibility. Ethical considerations include ensuring equitable access to the device in resource limited healthcare systems, and selecting safe, biocompatible materials.
