Description

The Montgomery Salivary Bypass Tube, developed by Boston Medical Products, Inc., is an advanced medical device designed to address complex clinical needs in the management of esophageal and hypopharyngeal conditions. This implantable stent is specifically crafted for use in the cervical esophagus and hypopharynx, providing essential support in the treatment of fistulae and strictures, particularly following head and neck surgeries such as total laryngectomy.

Clinical Applications

This device is invaluable for patients dealing with pharyngocutaneous fistula (PCF), tracheoesophageal fistula (TEF), and pharyngoesophageal stenosis (PES). By directing saliva into the distal esophagus, it promotes healing and closure of fistulae, preparing tissues for potential surgical repair. The tube's design facilitates oral feeding, reduces salivary leakage over fistula sites, and enhances wound healing, making it suitable for both temporary and long-term management.

Key Features

• Material Composition: Available in clear and radiopaque versions, the tube is made from implant-grade silicone. The radiopaque version includes barium sulphate and titanium dioxide, ensuring visibility under imaging.
• Design: The funnel-shaped proximal end fits securely in the hypopharynx, preventing reflux and accommodating a feeding tube if necessary.
• Safety: The device is MRI safe and supplied sterile, with each tube packaged individually.

Usage and Monitoring

Insertion and removal of the tube are performed under general anesthesia. It is well tolerated for both short-term and long-term use, with some patients using it effectively for up to three years or more. Regular monitoring by a physician is crucial to ensure proper placement and to manage any local tissue reactions. Users are advised not to expose the device to heat-based procedures and to avoid use if the device is damaged.

Available Sizes

The Montgomery Salivary Bypass Tube comes in various sizes, with dimensions tailored to meet specific clinical needs:

• Size 8: 33:191:8 mm
• Size 10: 35:191:10 mm
• Size 12: 37:191:12 mm
• Size 14: 39:191:14 mm
• Size 16: 41:191:16 mm
• Size 18: 43:191:18 mm
• Size 20: 45:191:20 mm

Each size is available in both clear and radiopaque versions, providing flexibility in clinical application.

Risks and Precautions

While the device offers significant benefits, potential complications include foreign body sensation, tube migration, and localized pressure necrosis. Rare but serious risks such as arterio-esophageal fistula and intestinal perforation have been noted. Therefore, continuous monitoring and appropriate management are essential to mitigate these risks.

Conclusion

The Montgomery Salivary Bypass Tube stands as a critical tool in the management of complex esophageal and hypopharyngeal conditions, offering tailored solutions to enhance patient outcomes in challenging clinical scenarios.