To design a solution that would prevent further aggravation of granulation tissue around the patient’s stoma from the MIC-KEY button feeding system.
The design solution had to be deployable without removing the MIC-KEY button from the stoma tract.
The completed, functional device was fitted less than 24 hours after initial discussions between the clinical and design teams.
This patient is a child fully dependent on PEG feeding who had a PEG tube inserted at six months of age (MIC-KEY tube, Avanos Medical, Georgia, USA). Within weeks of siting the PEG, his parents complained of frequent bleeding and oozing from the stoma. Treatment with topical and systemic antibiotics did not help. A granuloma at the stoma was noted. Treatment with silver nitrate impregnated dressings proved unsuccessful. The application of gauze to act as a barrier did not result in an improvement.
After consultation with the RIU team, three key objectives were identified; to remove focal pressure points caused by the edges of the MIC-KEY device, to reduce the movement of the PEG tube within the stoma tract, and to compress the granulation tissue.
Overnight, a design was created for an all in one convex spacer (Shield) with an integrated hinge suitable for 3D printing. The hinge allowed the device to be placed under the MIC-KEY tube without removing it from the stoma. The Shield was fabricated using 3D printing on the Connex 500 3D printer using the Med 610 material, which is a USP Class IV approved material for prolonged skin contact (<30 days). The shield was worn under the body of the MIC-KEY button during waking hours only for a period of 7 days. The patient was reviewed at the end of the week in clinic where it was noted that the granuloma had completely resolved.