Publishable Summary (at 12 Months) Abstract The goal of the proposed project is to develop a novel, non-invasive and biocompatible fibre optic sensor for pressure monitoring in biomedical applications. The project is hosted by the Optical Fibre Sensors Research Centre (OFSRC) at the University of Limerick, Ireland. Fibre optic sensors (FOS) represent the best performing sensing technology for pressure, strain and temperature detection. FOS are extremely sensitive, non-invasive and biocompatible, extremely suitable for application in biomedical sensors. In this framework, OFSRC is currently developing a fibre optics biomedical sensor for measurement of vesicourethral pressure for diagnosing urodynamic disorders. Preliminary experiments and trials show that this instrument provides increased performance and is more comfortable for patients than alternative technologies. Summary Of The Project Objectives The Overall aims of the project are as follows: Fabrication of a multipoint, biocompatible, miniaturized and temperature-compensated optical fibre sensor probe, to be inserted into a catheter for Bladder Outlet Obstruction (BOO) measurement. Development of a suitable interrogation system for the probe, compatible with portability, cost and power consumption constraints. Assess the successful operation of the probe through clinical diagnostics. Validation of the use of Optical Fibre Sensors (OFS) in clinical diagnosis. Quantification of the benefits for patients and hospital with respect to alternative technologies. Implement a telemedicine platform for the system, transmitting real-time measurement data to the outside. Start technology transfer practice once the sensor has proven to be successful. A description of the work performed since the beginning of the project, The OFSRC team including the MC researcher has established and greatly enhanced a manufacturing procedure for pressure/temperature optical fibre sensors, with performance superior to that of the current state of the art. The Sensor has been successfully tested in three separate deployments in a clinical environment (i) Extensive patient testing at the Urology Clinic of the Frederico II Hospital, Naples, Italy. (ii) The Extrinsic Fabry Perot Interferometer (EFPI) probe has been also applied in a cardiovascular context: using a differential EFPI pressure probe, it was possible to diagnose arterial sthenosis through measurement of Fractional Flow Reserve (FFR). a demonstration was conducted at Cleveland Clinic (Cleveland, US) with Pointec Medical Ltd (Galway), which acquired the license for the technology for Cardiovascular Applications. (iii) The combined EFPI/FBG (Fibre Bragg Grating) system has been applied to the monitoring of Radio Frequency thermal Ablation (RFA) in the liver. The goal is to improve the efficiency of RFA in treatment of liver tumors by monitoring pressure and temperature. The project involves OFSRC-UL, Universita’ di Pavia, Politecnico di Milano and San Martino Hospital (all Italian partners). An ex-vivo experiment on porcine liver has been successfully carried out – and will be published shortly – in Sept 2013; in A Description Of The Main Results Achieved So Far, The Results relating to (i) and (iii) of the above three testing events are included in Fig 1 and Fig 2 below Fig.1. Comparison of bladder pressure measured with EFPI probe (above) and traditional PICO2000 urodynamic instrument (below). The chart shows the whole 12-minutes urodynamic test. Time (Sec) Fig 2. Pressure/temperature trace during ex-vivo RFA. The results of Fig 1 and 2 clearly show that the Optical Fibre Sensors of this investigation is capable of performing in clinical environments at a level of performance above that of commercially available and competing technologies. The Expected Final Results And Their Potential Impact And Use (Including The Socio-Economic Impact And The Wider Societal Implications Of The Project So Far). The Expected final results will be provide a thorough validation for the clinical use of Optical Fibre Sensors in a wide range of applications as shown to date. The use of the combined Pressure and Temperature OFS in this manner provides a unique opportunity for the commercial development of the sensors based on strong existing Intellectual Property (IP) already established within OFSRC. The EU represents the perfect marketplace for innovation within the biomedical sector. The excellent levels of medical structures, together with flexible and clear procedures for testing and FDA approvals, create a favourable environment for starting biomedical projects and businesses. Furthermore, Europe provides effective IP protection for technologies, which helps maintaining the initial competitive advantages. In this framework, therefore, EU retains a competitive edge. Recently, Ireland has exerted a strong push to hi-tech entrepreneurial projects and technology transfer, propelling the creation of several startups within the biomedical as well as the wider sensor technology area, and creating the opportunities for business development. In order to keep the pace with the required rate of innovation in the biomedical sensors area, a relevant effort will be allocated to the building of an excellence network in the realization of miniaturized and biocompatible sensors, to improve medical devices. Through the process of building a team with multidisciplinary skills, capable of making disruptive innovation as well as bringing it to the market, OFSRC with the assistance of the MC Fellow of this project can maintain the lead in this fast-growing market.