Title: Next generation multifunctional endoscopic LED light source prototype
Funder: Department of Health (England)

Abstract: The research is divided into two instruments, the 800 lumen red-green-blue-violet source and the 1600 lumen source. The first of these will be a direct replacement for the Karl Storz D-light C system, and has been chosen as an achievable aim that can gain market penetration. The second development cycle involves more research challenges but the reward will be a source that can replace the majority of all endoscopic lamps currently in use. The partners will review and approve the specification for the two light sources, working together on the mechanical, optical and electrical objectives. The work on the 800 lumen RGBV source will commence first, beginning with a light engine modelling for optimal fibre optic or liquid light guide coupling and electrical drive conditions. Thermal management is critical and will impact on performance and longevity. Digital control will allow a user friendly interface where the operator can quickly change brightness and colour. This will help the clinical evaluation and will be essential for FD, where the light source will need to be rapidly switched from white to violet. The mechanical design will include the jigs for building the optical devices and fixing components. A design review will be carried out to reference the original technical and commercial specification. Manufacturers will be identified, orders will be placed and the device will be built and reviewed with ICL and Karl Storz. The evaluation of the final light source at ICL will include an initial laboratory study involving ergonomics, perception and manual task performance. This will test the colour temperature, flicker, brightness, working distance, shadowing and ease of control. Surgeons with a range of different clinical levels and specialities will participate to ensure validity. The clinical study will include the submission of an ethics application to allow a xenon source to be substituted for the LED light during MIS. The potential for FD will be evaluated with Dr Mayer, who has experience in FD cystoscopy. The instrumentation for this procedure was originally developed by Karl Storz, who will provide advice on how to optimise the lighting, colour balance and choice of filters to contrast tumourous tissue from surrounding normal tissue. The 1600 lumen source involves an innovative concept utilising phosphor technologies (UK Patent Application No. 1114495.3) and the combination of blue and violet LEDs for high power phosphor excitation (see the previous work by the applicants in this area – Nadeau et al.). Optical design will be required to collect the light from the phosphor and the light sources as efficiently as possible, and optical coatings must be designed so that the light is redirected from the source to the phosphor. Thermal management, electrical and mechanical designs will be similar to the 800 lumen device. Based on the detailed specifications, suitable manufacturers will be identified, orders will be placed and an initial build will then be carried out. The 1600 lumen LED light source will be tested during the remaining time available both in the laboratory and in the clinic. Standard endoscopic procedures will be carried out by multiple clinicians and the light source will be switched from xenon to LED. The exploitation plan will be produced between Imperial, Cymtec and Storz based on the results obtained during the initial testing phase and the clinical evaluation at ICL. It is our aim to produce an advanced prototype of the 800 lumen RGB light source where the route to market is compelling. It is likely that the exploitation plan will be developed shortly after the prototype is completed so that Cymtec and Storz can maintain the competitive advantage that this project will generate.


Research activity codes: 6.3 MEDICAL DEVICES;5.3 MEDICAL DEVICES
Health categories: GENERIC HEALTH RELEVANCE