Intratracheal Seal Disc: A Novel Tracheostoma Closure Device

BACKGROUND: Tracheostomy decannulation is accompanied by several clinical concerns due to air leakage. In this study, we introduced a novel tracheostoma closure device that facilitates the use of noninvasive ventilation, improvement of pulmonary function, and vocalization in the newly decannulated patient. The biosafety and feasibility of the device were evaluated in an animal model.

METHODS: Five Danish Landrace pigs were subjected to tracheostomy followed by decannulation and insertion of the tracheostoma closure device. Correct placement of the device was ensured by flexible tracheoscopy. The device consisted of an intratracheal silicone seal disc fixated by a cord through the stoma to an external part. At day 14, computed tomography (CT) was performed before the device was extracted. With the pulling of a cord, the disc unraveled into a thin thread and was extracted through the stoma. At day 21, CT was repeated before euthanasia. The trachea and epidermis were excised en bloc for histopathological evaluation.

RESULTS: Insertion and correct placement of the disc was unproblematic in all animals. CT at day 14 confirmed a clear airway, appropriate placement of the disc, and full closure of the tracheostoma. Extraction was successful in one animal but complicated in the remaining animals. There was histological evidence of healing after the foreign body placement.

CONCLUSIONS: The study demonstrated that the tracheostoma closure device is feasible and biosafe in a porcine animal model, but the design and quality of the materials need to be improved before clinical trials.