Description

The Montgomery Salivary Bypass Tube, developed by Boston Medical Products, Inc., is a specialized implantable stent designed for use in the cervical esophagus and hypopharynx. This medical device is intended to manage and prevent fistulae or strictures that may arise from surgery, radiation, malignancy, trauma, or caustic ingestion. By directing saliva into the distal esophagus, it promotes healing and aids in the spontaneous closure of fistulae, while also preparing tissue for potential surgical repair.

Design and Material

The tube features a funnel-shaped proximal end that fits the hypopharynx, helping to prevent reflux of stomach contents. It is available in both clear and radiopaque versions, with the clear version made from 100% implant-grade silicone. The radiopaque version is crafted from silicone blended with barium sulphate and titanium dioxide. Both versions are supplied sterile and are MRI safe, ensuring compatibility with medical imaging.

Functional Benefits

• Versatile Use: The device can accommodate a feeding tube, allowing for oral feeding while managing fistulae and strictures. This enables patients to maintain normal oral intake and daily activities.
• Patient Population: Intended for adult patients of all genders, it can be used for both short-term and long-term management, including lifelong use if necessary.

Available Sizes

The Montgomery Salivary Bypass Tube is offered in various sizes, with lengths consistently at 191 mm and diameters ranging from 8 mm to 20 mm. This range allows for tailored application to meet individual patient needs.

Application and Safety

Insertion and removal of the tube are minor procedures typically performed under general anesthesia. Regular follow-up is recommended to monitor placement and manage any potential complications, such as tube displacement or pressure necrosis. The device should not be exposed to laser therapy, argon plasma coagulation, or high-frequency surgery to avoid tissue injury or product damage.

Potential Complications

While generally well tolerated, possible complications may include foreign body sensation, dislocation, or migration of the tube, and rare instances of localized pressure necrosis. No significant infections have been reported, underscoring its safety profile.

Maintenance

Ongoing monitoring is advised to ensure proper placement, with adjustments or size changes made as necessary. This proactive approach helps in managing any minor issues that may arise, ensuring the device continues to function effectively in promoting healing and managing esophageal and hypopharyngeal conditions.