Description

The Montgomery Salivary Bypass Tube, crafted by Boston Medical Products, Inc., is an advanced medical device designed to address complex conditions in the cervical esophagus and hypopharynx. This implantable stent is specifically engineered to manage fistulae and strictures, providing a crucial solution for directing saliva into the distal esophagus. By doing so, it significantly reduces contamination of cervical tissues, promoting the spontaneous closure of fistulae and enhancing tissue conditions for further repair.

Key Features

• Funnel-Shaped Design: The proximal end of the tube is funnel-shaped, facilitating effective saliva collection and preventing distal displacement.
• Hollow Structure: Allows the passage of oral contents from the mouth to the esophagus, accommodating a feeding tube if necessary.
• Material Options: Available in clear and radiopaque versions, made from implant-grade silicone, with the latter incorporating barium sulphate and titanium dioxide.
• Size Variability: Offered in diameters ranging from 8 mm to 20 mm, all with a standard length of 191 mm.
• MRI Safe: Ensures compatibility with MRI procedures, enhancing patient safety.

Intended Use

This device is suitable for both temporary and long-term management, with a recommended maximum application duration of six months. It is particularly beneficial for patients with:

• Pharyngocutaneous fistula (PCF)
• Tracheoesophageal fistula (TEF)
• Pharyngoesophageal stenosis (PES)

These conditions often arise post-laryngectomy or in individuals with advanced pharyngeal carcinoma. The tube aids in stenting repairs, preventing or managing fistulae resulting from surgery, radiation, malignancy, trauma, or caustic ingestion.

Instructions for Use

The Montgomery Salivary Bypass Tube is inserted under general or local anesthesia, requiring regular monitoring by a physician. Patients are advised to consume pureed foods and maintain hydration to prevent blockage. It is crucial to avoid exposure to heat-based procedures such as laser therapy during its use.

Potential Complications

While well-tolerated, potential complications may include:

• Impaired arytenoid motility
• Foreign body sensation
• Tube migration

Rare but serious risks involve arterio-esophageal fistula and intestinal perforation due to tube migration. Regular follow-up is recommended to manage these risks effectively.

Sterility and Packaging

Each tube is supplied sterile, intended for single use, with one tube per carton. This ensures the highest standards of hygiene and safety, aligning with the needs of both short-term and long-term medical management.

The Montgomery Salivary Bypass Tube stands as a vital tool in facilitating healing and oral nutrition, offering a reliable and sophisticated solution for patients with intricate head and neck conditions.