P401 - Novel biodegradable multilayered polymer colorectal stent for improved anastomotic healing and outcomes

Purpose/Background: Anastomotic leak remains one of the most devastating complications in colorectal surgery, contributing to significant morbidity, mortality, and healthcare cost. Current stent technologies-mainly self-expanding metal or covered stents-are limited by migration, tumor ingrowth, and the need for removal. This ongoing project aims to design a novel, biodegradable, multilayered polymer colorectal stent with drug-eluting capabilities to enhance anastomotic healing, reduce leak rates, and eliminate the need for stent retrieval.

Methods/Interventions: In collaboration with the University of Tennessee Biomedical Engineering Department, a multilayered polydioxanone (PDO)-based stent was designed to combine mechanical strength, elasticity, and drug-eluting functionality. Multiple prototypes were fabricated and underwent mechanical and material characterization, including tensile strength, elasticity under hydration, and degradation rate testing. The stent's radial force and integrity were assessed under simulated colonic conditions. Future phases include cadaveric validation for deployment feasibility and animal model testing to evaluate in vivo healing and migration outcomes.

Results/Outcomes: Initial prototypes demonstrated appropriate expansion properties and radial strength sufficient to resist physiologic bowel pressures. Hydrated-state elasticity confirmed durability and flexibility without structural compromise. Degradation testing indicated predictable polymer breakdown consistent with intended temporary support during anastomotic healing. The design successfully integrates a potential drug-eluting matrix to deliver localized therapy, providing both mechanical and biochemical benefits. The device received first place at the University of Tennessee Biomedical Engineering Product Design Competition, validating its translational potential.

Conclusion/Discussion: This novel biodegradable multilayered polymer stent represents a promising innovation in colorectal surgery. Its design aims to enhance anastomotic integrity, minimize leak rates, and reduce postoperative complications. Ongoing development will include cadaveric and animal model evaluation to assess clinical feasibility and safety prior to human trials.

Mucoadhesive testing
Leak testing