Efficient Objective Metric Tool for Medical Electrical Device Development: Eye Phantom for Glaucoma Diagnosis Device

摘要

Developing electronic medical devices is challenging. Simulations or in vivo experiments are not sufficient to obtain pertinent comparisons between potential design options. This paper presents a new artificial tool allowing objective comparisons between electronic device topologies. The main idea is to build a tool which is sensitive to targeted biological parameters only. These tools are generally called phantoms. The phantom presented in this paper is dedicated to IntraOcular Pressure (IOP) Measurement devices used in glaucoma diagnosis and treatment. It is called Biomechanical Eye Emulator (BEE). The BEE emulates the main biomechanical parameters influencing the IOP measurements. Because it is not sensitive to the living context, the BEE is the most efficient tool to investigate the best sensor design. BEE specifications are defined to be as close as possible to chosenmodels (humans or animals). Its efficiency is shown with a case study on rabbits. The results clearly demonstrate the BEE phantoms efficacy in providing objective assessment metrics during the sensor design process.