In vivo experiments with tracheostoma tissue connector prototypes

Area of Science:

• Biomedical Engineering
• Otolaryngology
• Surgical Innovation

Background:

• Laryngectomy patients require voice rehabilitation, ideally using a tracheostoma valve (TSV) for hands-free tracheo-esophageal speech.
• Current TSV fixation methods are often difficult for patients, hindering effective voice restoration.
• Tracheostoma tissue connector (TS-TC) prototypes were developed to enhance TSV stability.

Purpose of the Study:

• To evaluate the efficacy of two prototype tracheostoma tissue connectors (TS-TCs) in an animal model.
• To assess the feasibility of a two-stage implantation procedure for TS-TCs.
• To investigate tissue response and screw fixation following TS-TC implantation.

Main Methods:

• Two TS-TC prototypes with titanium and polypropylene components were designed for TSV fixation.
• A tracheostoma was surgically created in adult female goats, followed by TS-TC implantation.
• Histological examination was performed after a 12-week implantation period, including percutaneous screw insertion at 6 weeks.

Main Results:

• Clinical outcomes during weeks 7-12 ranged from poor to relatively good.
• Histological analysis revealed a uniform inflammatory response around the implants.
• Epithelial down growth was observed in the tissue surrounding the screws.

Conclusions:

• The two-stage implantation of prototype TS-TCs in the goat model was unsuccessful.
• Current designs require further research to improve tissue immobilization and reliable fixation for TSVs.
• Development of improved fixation systems is crucial for successful voice rehabilitation in laryngectomy patients.