Innovating for Ileostomates

Project Overview:

Ileostomy patients face ongoing challenges with hygiene, autonomy, and skin health due to continuous stoma output and limitations in current ostomy products. This study presents the design and evaluation of a controllable stool management system that enables temporary stoma closure and intentional waste release. The system comprises a soft silicone plug with radial anchoring fins, a tricuspid-style duckbill valve for one-way flow control, and a quick-connect interface for attaching a disposable collection bag.

Bench testing evaluated the system against key functional requirements. The anchoring mechanism produced an average radial pressure of 15.76 mmHg, within the safe range of intestinal wall pressures. The valve sustained pressures up to 128 mmHg without leakage in nearly all trials, indicating robust sealing well above normal intraluminal conditions. Pullout force tests confirmed secure retention exceeding physiological pressures while remaining below thresholds for tissue damage. These results validate the system’s mechanical feasibility for in vivo use.

The bag attachment force remains untested, representing an area for future work. Additional refinement is needed in valve fabrication, usability, and material durability. Overall, the proposed system offers a novel, user-controlled approach to improve comfort, reduce leakage, and support greater independence in ileostomy care.