Description
The Blom-Singer Voice Prosthesis with a Large Esophageal Flange is a specialized medical device designed to restore speech for individuals who have undergone a total laryngectomy. This indwelling device facilitates tracheoesophageal voice restoration by allowing air to pass from the lungs into the esophagus, enabling speech while preventing the aspiration of food, liquids, and saliva into the trachea.
Key Features
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Enhanced Seal and Stability: The large esophageal flange provides a secure seal, particularly beneficial for patients with enlarged or irregularly shaped puncture tracts. The double flange design offers a "double seal" to manage leakage around the prosthesis effectively.
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One-Way Valve Mechanism: This feature allows airflow necessary for speech while preventing aspiration, ensuring safe and effective communication.
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Indwelling Design: Intended for clinician placement and management, the device supports safe and convenient downsizing from a wider to a smaller diameter prosthesis.
Material and Maintenance
Crafted from medical-grade silicone, the prosthesis is durable and requires regular cleaning and maintenance due to its non-resistance to biofilm. It may be used in conjunction with a heat and moisture exchanger (HME) for optimal performance.
Available Sizes
The device is available in diameters of 16FR and 20FR, with lengths ranging from 4mm to 14mm. The esophageal flange size extends up to 19mm, allowing for customization to achieve a snug flange-to-flange seal, crucial for its effectiveness.
Clinical Considerations
Inserted into a surgically created tracheoesophageal puncture (TEP), the prosthesis may require custom modifications for certain patients. Its lifespan varies, with clinical studies reporting a median duration of 42 days and a mean of 71 days. Potential complications include leakage, granulation tissue, and prosthesis displacement, which may necessitate additional interventions.
Suitability
While not suitable for all patients, the Blom-Singer Voice Prosthesis Large Esophageal Flange offers significant benefits for those with challenging puncture anatomy, providing a reliable solution for voice restoration post-laryngectomy.
