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, which is within the safe range for 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.

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In vitro studies at Massachusetts General Hospital provided evidence that, in a stoma environment, the anchoring mechanism is resilient enough to hold the bag attachment in place when unfilled. However, it was difficult for people with larger fingers to insert, as it required a fold-and-push method to properly secure inside the stoma, and the bag's failure load was relatively limited. Although additional refinement is needed for valve fabrication and the addition of an anchoring belt would increase fluid holding capacity, the proposed system offers a novel, user-controlled approach to improve comfort, reduce leakage, and support greater independence in ileostomy care.