Description

Designed for individuals who have undergone a total laryngectomy, this indwelling tracheoesophageal (TE) voice prosthesis plays a crucial role in voice rehabilitation. The large esophageal flange feature is engineered to provide an enhanced seal, effectively managing leakage around the prosthesis, particularly in cases with enlarged or irregular puncture tracts. This ensures a more stable and reliable performance, allowing for clearer speech production.

Key Features

• One-Way Valve System: Facilitates the passage of exhaled air from the trachea into the esophagus, enabling speech while preventing food, liquid, and saliva from entering the trachea.
• Secure Placement: Flanges on both the tracheal and esophageal sides keep the device securely in place, reducing the need for frequent adjustments.
• Versatile Sizing: Available in diameters of 16 French (FR) and 20 French (FR), with lengths ranging from 4mm to 14mm, accommodating various anatomical needs.

Material and Design

Crafted from medical-grade silicone rubber, the prosthesis is available in both sterile and non-sterile versions. The sterile version is intended for primary placement, while the non-sterile version is suitable for replacements. Some models incorporate anti-fungal additives, such as silver oxide, to minimize biofilm and Candida growth, prolonging the device's functional lifespan.

Maintenance and Accessories

Regular cleaning is essential to prevent biofilm accumulation, which can lead to leakage. Accessories such as a flushing device, brush, and plug insert are available to aid in maintenance. In cases where immediate replacement is not feasible, a plug can be used to block leakage, though speech is not possible with the plug in place.

Performance Characteristics

The prosthesis is designed to offer minimal resistance to speech airflow, particularly in the 20FR models, enhancing voice quality and ease of speech. Device lifetime varies significantly, influenced by individual patient factors, with a mean duration of 71 days and a median of 42 days.

Clinical Considerations

Voice quality is dependent on pulmonary support and the airflow resistance of both the prosthesis and the neoglottis. The device may be used alongside heat and moisture exchangers (HME) and optional virus/bacteria filters. While some models are patient-changeable, others require clinician placement, typically conducted in clinical settings such as hospitals and ENT clinics.

Common Challenges

Potential issues include leakage through or around the device, fistulae growth, granulation tissue, and increased valve opening pressure. Device longevity may be affected by factors such as diet, radiotherapy, and gastroesophageal reflux disease (GERD).

This voice prosthesis is a robust and durable solution, designed to significantly improve the quality of life for post-laryngectomy patients by restoring their ability to communicate effectively.