Description

The Blom-Singer Advantage Indwelling Voice Prosthesis is a specialized medical device designed for individuals who have undergone a total laryngectomy. This indwelling tracheoesophageal voice prosthesis plays a crucial role in voice restoration, providing a reliable solution for those seeking to regain speech post-surgery.

Key Features

• One-Way Silicone Valve: The prosthesis features a one-way silicone valve embedded with silver oxide, serving as a material preservative. This innovative design may reduce or eliminate the need for anti-fungal agents for some users.

• Secure Placement: Equipped with an easy-fold esophageal retention flange and a flange introducer, the device ensures secure placement. The Blom-Singer Gel Cap Insertion System further facilitates atraumatic insertion.

• Maintenance System: The included Brush and Flush Cleaning System, complete with built-in safety features, supports effective maintenance. This ensures the device remains functional and hygienic over time.

Sizing and Materials

Available in two diameters (16 Fr. and 20 Fr.) and various lengths ranging from 4 mm to 22 mm, the prosthesis is crafted from medical-grade silicone. The non-sterile device is intended for use in both primary and secondary tracheoesophageal puncture (TEP) procedures, with placement and replacement performed exclusively by a clinician.

Functionality

The primary function of the Blom-Singer Advantage Indwelling Voice Prosthesis is to restore speech by directing pulmonary air from the trachea into the esophagus, enabling voice production. The valve effectively prevents food, fluids, and saliva from entering the trachea, safeguarding the airway.

Daily Care and Monitoring

Daily cleaning is required using the provided brush and flush system. As an indwelling device, it remains in place until changed by a clinician. Users are advised to monitor for leaks or changes in voice quality and seek medical attention if any issues arise.

Clinical Insights

Clinically, the device is noted for being the first voice prosthesis to incorporate silver oxide in its valve component. Studies report a median device lifespan of 67 days, though this can vary widely. Common reasons for removal include leakage, valve obstruction, or biofilm growth, with device life largely unaffected by the extent of surgery.

Precautions

The device must remain securely in place at all times. Should any leakage or dislodgement occur, immediate medical attention is necessary to address these concerns effectively. This ensures the continued safety and efficacy of the voice prosthesis for the user.