Description

The Blom-Singer Duckbill Voice Prosthesis is a specialized tracheoesophageal voice prosthesis designed to restore speech in individuals who have undergone a total laryngectomy. This innovative device enables voice production by redirecting exhaled air from the lungs through a surgically created passage between the trachea and esophagus.

Key Features

• One-Way Valve Mechanism: The duckbill-shaped valve allows air to pass from the trachea to the esophagus for speech while preventing food, fluids, and saliva from entering the windpipe during swallowing.
• Patient-Changeable Design: This non-indwelling device allows for independent insertion, removal, and cleaning by the patient, featuring a safety strap for self-replacement and maintenance.
• Medical-Grade Silicone: Constructed from high-quality materials, it offers durability and compatibility with the body.

Available Sizes

The prosthesis is available in a 16 French (Fr) diameter and comes in multiple lengths, ranging from 6mm to 25mm, to accommodate individual anatomical needs.

Design Attributes

• Non-Flanged, Cylindrical Tube: Secured with two flanges to ensure proper placement.
• Insertion Methods: Can be inserted retrograde through the mouth and throat or anterograde through the stoma, with the latter being more common.

Operation

Speech is produced by directing air from the lungs through the prosthesis into the esophagus, causing tissue vibration and sound production. The valve opens under positive pressure during exhalation and closes to protect the airway during swallowing. Users can produce speech by covering the stoma with a finger or using a hands-free valve accessory.

Maintenance and Cleaning

Daily cleaning is essential to prevent leakage and maintain functionality. Cleaning tools such as a dedicated brush and flush device are used to remove mucus and debris. Regular inspection for leaks or buildup is necessary, and the device's lifetime can vary based on individual factors such as diet, radiotherapy, and reflux.

Patient Considerations

Suitable for most laryngectomy patients, the prosthesis requires individual assessment. Training from Speech and Language Therapists is provided for optimal use, with voice quality depending on pulmonary support and airflow resistance.

Certifications

The device is supported by certifications including ISO 9001:2015, ISO 14001:2015, ISO 45001:2018, ISO 27001:2013, and ISO 13485:2016, ensuring adherence to quality and safety standards.

Common Use Cases

The Blom-Singer Duckbill Voice Prosthesis is commonly used for voice rehabilitation after total laryngectomy. It can be used in combination with heat and moisture exchangers (HME) and optional hands-free valves for enhanced speech and pulmonary rehabilitation.