Feasibility of intratracheal tracheostomy sealing: anatomical adaptation and biocompatibility of a second-generation prototype in cadaveric and porcine models

After decannulation, air leak through the tracheostoma can impair cough and voice. We evaluated a second-generation temporary intratracheal sealing disc that seals the stoma from within. Two preclinical sub-studies were performed: Sub-study 1 cadaveric deployment to assess anatomical fit, seal integrity, and removability; and Sub-study 2, a 7-day porcine implantation with anatomical compatibility and blinded histology. In cadavers, the sealing disc maintained airway patency and sealed the stoma, withstanding peak intratracheal pressures up to 180 cmH₂O; removal through a near-healed opening required approximately 5 N traction. In the porcine model, no airway obstruction or clinical distress was observed, and histology (Phase Two) showed no excess inflammation or foreign body reaction versus sham. The sealing disc provided intraluminal sealing of the tracheostomy with feasible insertion and removal characteristics and a favorable short-term tissue response in preclinical models. These findings support clinical feasibility testing of this approach to maintain an intact airway dynamic during early post-decannulation healing.