College - Author 1
College of Engineering
Department - Author 1
Biomedical Engineering Department
Degree Name - Author 1
BS in Biomedical Engineering
Christopher Heylman, Michael Whitt
The purpose of this document is to provide a development summary for a proposed esophageal temperature mapping device used during catheter ablation. Catheter ablation therapy is performed in the left atria with hot or cold materials to create scar tissue to treat atrial fibrillation. However, utilized temperatures and absorbed energies from the catheter can cause undesired esophageal damage. Therefore, this medical device is designed to monitor esophageal temperature and map its location during catheter ablation. If dangerous temperatures are reached, the device will alarm the surgeon.
This document provides an in-depth overview of the esophageal temperaturemapping device’s development and contains seven sections: introduction and background, customer requirements and design specifications, stage gate process, description of final prototype design, prototype development, IQ/OQ/PQ, and conclusions and recommendations.