Description

Designed for adults who have undergone a total laryngectomy, this indwelling tracheoesophageal (TEP) voice prosthesis plays a crucial role in voice rehabilitation. By redirecting air from the lungs into the esophagus through a surgically created tracheoesophageal puncture, it enables speech via a sophisticated one-way valve system.

Key Features

• Large Esophageal Flange: Provides enhanced stability and sealing, effectively managing leakage and preventing dislodgement. This feature is particularly beneficial for patients with enlarged or irregularly shaped puncture tracts.

• One-Way Valve: Allows air passage from the trachea to the esophagus, facilitating speech while preventing food, liquids, or saliva from entering the trachea.

• Medical-Grade Silicone: Constructed from durable, medical-grade silicone, ensuring robustness and ease of maintenance.

Design and Variants

The prosthesis includes a tube design between the flanges, with some models offering a larger inner diameter to increase airflow, reduce speaking effort, and enhance voice quality. Available in diameters of 16 French (Fr) and 20 French (Fr), and lengths ranging from 4mm to 14mm, it caters to diverse patient needs.

Model Options

• DUAL VALVE™
• ADVANTAGE®
• CLASSIC®
• LOW PRESSURE
• DUCKBILL
• Rapid Response

These models provide various features such as valve resistance options to optimize airflow and minimize unintentional valve opening.

Additional Features

• Antifungal Additive: Some models incorporate silver oxide to reduce Candida growth and biofilm formation.

• Accessories: May include cleaning brushes, flushing devices, plug inserts, and dedicated insertion systems like the Gel Cap Insertion System.

Placement and Maintenance

As an indwelling device, it requires clinician placement and periodic replacement, with insertion confirmed endoscopically. The lifespan varies, with regular maintenance needed to prevent biofilm and yeast growth. Accessories for cleaning are readily available to support this.

Performance

The device is designed to enable clear, lung-powered speech, with larger diameters and optimized airflow characteristics reducing speaking effort. It is often used alongside heat and moisture exchangers for pulmonary rehabilitation, contributing to generally clear voice quality.

Patient Suitability

Intended for a patient population typically aged 34 to 92 years, the prosthesis is most effective when achieving a snug flange-to-flange seal with the correct length. Available in both sterile and non-sterile forms, it addresses common replacement needs such as leakage, valve obstruction, and tissue formation, ensuring continued effectiveness in voice rehabilitation.