Steroid eluting biocompatible stent for subglottic stenosis.

Area of Science:

• Biomaterials Engineering
• Medical Device Development
• Otolaryngology

Background:

• Subglottic stenosis presents a significant challenge in airway management.
• Current endoscopic treatments often lack sustained efficacy.
• A need exists for innovative stent designs that provide mechanical support and therapeutic elution.

Purpose of the Study:

• To develop and characterize a prototype steroid-eluting stent for endoscopic treatment of subglottic stenosis.
• To assess the mechanical properties and drug release profile of the novel stent design.

Main Methods:

• 3D printing of polycaprolactone (PCL) stents with a spoke design using AutoCAD.
• Embedding Kenalog-saturated Aerosil 200 into the PCL filament.
• Measuring radial force at baseline, 1 day, 1 week, and 1 month.
• Quantifying Kenalog elution using High-Performance Liquid Chromatography (HPLC).

Main Results:

• The PCL stent exhibited increasing horizontal radial pressure over one month, indicating sustained mechanical support.
• Kenalog elution increased from 5.78 µg/mL at 1 day to 19.35 µg/mL at 1 month.
• The stent design allows for mucosalization and gradual dissolution while eluting steroids.

Conclusions:

• This proof-of-concept demonstrates a novel, dissolvable, steroid-eluting stent for subglottic stenosis.
• The stent provides increasing expansile force and sustained drug delivery.
• Further in vivo studies in animal models are warranted to evaluate efficacy and safety.