Pediatric Airway Stent to Treat Tracheobronchomalacia
Background
Tracheobronchomalacia (TBM) is a congenital defect of the central airways that has been identified in up to 15% of infants and 30% of young children undergoing bronchoscopic examination for respiratory distress. The condition can arise due to intrinsic weaknesses in the trachea and can cause the windpipe to collapse when breathing or coughing.
The only FDA-approved treatment for neonates and infants is to apply positive pressure ventilation to raise the intraluminal pressure sufficiently to prevent airway collapse during breathing. During the 3-to-9-month treatment period, a child remains connected to a ventilator and is closely monitored to provide regular suctioning of the endotracheal tube. However, even with suctioning, the inability to clear mucus causes an increased risk of airway infections such as pneumonia and tracheitis. Stents are another treatment option, but currently have many drawbacks for neonates and infants. They are typically sized for adults, require invasive procedures for removal, frequently migrate, and can result in mucous plugging that hinders breathing.
Technology Overview
Boston Children’s Hospital researchers have invented a pediatric airway stent to combat these issues. The approach offers many advantages over current standards of care, including a patient-specific custom fit process to produce a stent by directly taking a mold of the patient’s airway, reducing the cost and time typically required for stent customization. The stent design is constructed to minimize the impairment of the mucociliary function by providing an unobstructed path along the length of the stent. The stent will be easily removed without an invasive procedure and is also designed to resist migration through the screw-like contact geometry of its design. Another advantage, recognizing that the stent only needs to provide a modest pressure to provide support to the trachea, is that the design is optimized to minimize the amount of foreign material in contact with the airway.
Applications
- Tracheobronchomalacia in pediatric populations
- The In vivo molding method has the potential to be applied to other stents, implants and patient populations.
Advantages
- Personalized stent that is cheaper and faster to produce than through current methods: since the process uses the patient’s own airway as the mold, the process can be performed entirely during stent delivery
- Stent geometry minimizes impairment of the mucociliary function compared to existing designs
- Stent geometry is optimized to minimize the amount of foreign material in contact with the airway
- A completely new and inexpensive fabrication technique in which flexible stent filled with a UV-curable polymer is molded in situ to the shape of the patient’s airway within a few minutes
