Abstract

To determine whether a custom laryngectomy tube can improve airway symptoms in total laryngectomy patients with atypical anatomy who are unable to use commercial laryngectomy tubes. Furthermore, to exemplify the power of customizable 3D printed medical devices when combined with the expanded access pathway through the FDA. A custom-fabricated laryngectomy tube, manufactured at in-house clinical engineering labs, was utilized for each patient following typical laryngectomy tube protocols. All participants had previously undergone a total laryngectomy. Patients were selected based on critical airway obstruction posing potentially life-threatening scenarios while using commercially available laryngectomy tubes. For all patients involved, there were no further airway obstruction complications or events, and they reported a subjective, significant improvement in comfort after placement of the custom laryngectomy tube. Custom laryngectomy tubes can provide patients with atypical anatomy relief from airway obstructions and improve comfort when commercial options fail to address the anatomic restriction. The process used to develop custom laryngectomy tubes may be relevant for other diseases and patients with atypical anatomies through the expanded access pathway.

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