Project Acronym: OPTIMO

Full title: Optical fibre device for simultaneous manometry, pH-metry and bilimetry in oesophagus

Project duration: 51 months
Coordinator: IFAC-CNR

Contact: Francesco Baldini

Project website address: www.optimo-project.eu

Executive summary

Target of the project is design and test of a new diagnostic instrument for gastroenterology. The project sees the involvement of three Tuscany partners (IFAC-CNR, Cecchi and University of Florence) and three German partners (IPHT, Jeti and Oscomed). The consortium is highly complementary, with two partners expert in optical sensing (IFAC-CNR and IPHT), two designers and manufacturers of optoelectronic components and devices (Jeti and Cecchi), one expert for manufacturing processes in the field of injection moulding and extrusion with know-how for cleanroom assemblies and sterilisation of disposable medical devices (Oscomed) and a clinical partner (University of Florence). The first part of the project is being devoted to the design of the combined catheter for the simultaneous monitoring of oesophageal pressure, pH and bile capable to satisfy the necessary requirements established by the physicians: pressure will be measured in 11 different positions along the catheter, bile and pH sensors will be positioned in correspondence of a window located 50 mm from the tip of the catheter, and a second pH sensor will be located in correspondence of the distal end of the catheter. The first prototype of the catheter is under development. Tests on the biocompatibility of the pH and bile probe to fulfil the criteria established by the European Directive on Medical Device are also in progress. Notwithstanding a phase shift in the starting date of the project – 30/03/2018 for Tuscany and 01/01/2019 for Germany – the project activity is not excessively affected by this delayed time lag.

Final project summary

The target of the present proposal is the design, implementation and characterization in real settings of a portable device based on an all-optical technology capable to perform simultaneously oesophageal manometry, pH-metry and bilimetry. It will provide physicians a compact and reliable tool to perform exhaustive diagnosis in gastroesophageal reflux pathologies. The project has seen the involvement of three Tuscany partners (CNR, CE and UNIFI) and three German partners (IPHT, JETI and OSCO). The consortium was highly complementary, with two partners expert in optical sensing (CNR and IPHT), two designers and manufacturers of optoelectronic components and devices (JETI and CE), one expert for manufacturing processes in the field of injection moulding and extrusion with know-how for cleanroom assemblies and sterilisation of disposable medical devices (OSCO) and a clinical partner (UNIFI).
The optical fibre sensors for bile detection, pH and pressure were realised and fully characterised, being able to satisfy the requirements established by the physicians involved in the project at the beginning of the project. The three different sensors were integrated in a single optical fibre catheter for the simultaneous measurement of the three parameters. The prototype for the interrogation of the catheter was designed and developed, constituted by the integration of two optoelectronic modules for the interrogation of the pressure sensor and for the bile and pH sensors, respectively. The prototype and the optical catheter are compliant with European Directives on medical devices in terms of electromagnetic compatibility, electrical safety and biocompatibility.
The clinical protocol for the assessment on healthy volunteers and patients was established and approved by the Ethics Committee for Clinical Trials of the Tuscany Region and the request to the Italian Ministry of Health for the implementation of the clinical tests is under evaluation.