E-Lumenate: Optimizing Treatment of Eosinophilic Esophagitis Using an Internal Phototherapy Device

Abstract

E-Lumenate is a minimally invasive phototherapy device designed to address the need for an effective, localized treatment for Eosinophilic Esophagitis (EoE), a chronic, inflammatory condition caused by excess eosinophilic cells within the esophageal tissue. EoE has increased fivefold since 2009, affecting about 1 in 700 people in the United States. Current treatments, including corticosteroids, proton pump inhibitors (PPIs), elimination diets, and dilation therapy, are limited by systemic side effects, poor long-term adherence, and high recurrence rates. E-Lumenate delivers narrowband UVB (311 – 313 nm) light to affected esophageal tissue to promote immunomodulation and epithelial healing. Combining a flexible fused-silica optical fiber diffuser with a biocompatible, UV-transparent ethylene tetrafluoroethylene (ETFE) catheter sheath, the device allows for the delivery of uniform irradiance along the length of the esophageal lumen. Critical-to-quality design specifications include: narrowband UVB wavelength; side-emitting fiber diffuser; external power and control; therapeutic dosimetry; and transoral insertion. The E-Lumenate system is designed with manufacturability and practicality in mind. The optical fiber diffusers are produced by a certified manufacturer to ensure consistent quality and precise wavelength. Conversely, the catheter sheath will be 3D-printed in-house using ETFE. Following therapy, catheters will undergo a high-level sterilization and reprocessing protocol using ethylene oxide (EtO), effectively reducing the long-term clinical costs and waste. The E-Lumenate device will cost about $2500 per unit to manufacture, which makes it a cheaper and more effective long-term therapy option compared to the current therapy options. E-Lumenate has the potential to establish a De Novo treatment method for EoE through effective, localized, and safe phototherapy.

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