Description

The Montgomery Salivary Bypass Tube is a specialized medical device designed to address complex clinical needs in the management of cervical esophageal and hypopharyngeal conditions. Its primary function is to stent repairs of strictures and manage fistulae that may arise from surgery, radiation, malignancy, trauma, or caustic ingestion.

Functionality

This device effectively diverts saliva into the distal esophagus, promoting the healing of fistulae and allowing tissue recovery for potential surgical repair. It can also accommodate a feeding tube, providing additional support in preventing fistulae and strictures, either independently or following dilation procedures.

Design Features

• Proximal End: The tube features a funnel-shaped proximal end designed to fit the hypopharynx, minimizing reflux and allowing seamless insertion of a feeding tube.
• Surface: Its non-adherent, smooth surface ensures ease of placement and removal.

Material Options

• Clear Version: Made from 100% implant-grade silicone.
• Radiopaque Version: Composed of implant-grade silicone with barium sulphate and titanium dioxide.

Packaging and Safety

• Supplied sterile and intended for single use.
• Each carton contains one tube and includes comprehensive instructions for use.
• The device is MRI safe, enhancing its compatibility with various clinical settings.

Size Specifications

The tube is available in sizes ranging from 8 mm to 20 mm, with a consistent length of 191 mm across all sizes. Diameter dimensions vary to match each size, providing tailored options for diverse clinical requirements. Both clear and radiopaque versions are available for all sizes.

Indications for Use

The Montgomery Salivary Bypass Tube is indicated for adult patients of all genders, suitable for both temporary and long-term management of specific esophageal and hypopharyngeal conditions. It supports oral feeding and daily activities, with reported use extending up to 2.5–3 years in some cases.

Clinical Considerations

Regular follow-up and monitoring by a physician are recommended to ensure optimal outcomes. The device should not be used if damaged and should be kept away from laser therapy, argon plasma coagulation, or high-frequency surgery.

Potential Complications

Possible complications include impaired motility of the arytenoids, foreign body sensation, dislocation, migration, and localized pressure necrosis, though these are rare. Removal and insertion are generally straightforward, typically performed under general anesthesia.

Maintenance

Ongoing monitoring and timely replacement in case of damage or complications are essential to maintain the device's effectiveness and patient safety.