Summary of the context and overall objectives of the project
Due to an ageing population and the spiralling cost of brain disease in Europe and beyond, EDEN2020 aims to develop the gold standard for one-stop diagnosis and minimally invasive treatment in neurosurgery. Supported by a clear business case, it will exploit the unique track record of leading research institutions and key industrial players in the field of surgical robotics to overcome the current technological barriers that stand in the way of real clinical impact. EDEN2020 will provide a step change in the modelling, planning and delivery of diagnostic sensors and therapies to the brain via flexible surgical access, with an initial focus on cancer therapy. It will engineer a family of steerable catheters for chronic disease management that can be robotically deployed and kept in situ for extended periods. The system will feature enhanced autonomy, surgeon cooperation, targeting proficiency and fault tolerance with a suite of technologies that are commensurate to the unique challenges of neurosurgery. Amongst these, the system will be able to sense and perceive intraoperative, continuously deforming, brain anatomy at unmatched accuracy, precision and update rates, and deploy a range of diagnostic optical sensors with the potential to revolutionise today’s approach to brain disease management. By modelling and predicting drug diffusion within the brain with unprecedented fidelity, EDEN2020 will contribute to the wider clinical challenge of extending and enhancing the quality of life of cancer patients – with the ability to plan therapies around delicate tissue structures and with unparalleled delivery accuracy.EDEN2020 is strengthened by a significant industrial presence, which is embedded within the entire R&D process to enforce best practices and maximise translation and the exploitation of project outputs. As it aspires to impact the state of the art and consolidate the position of European industrial robotics, it will directly support the Europe 2020 Strategy.
Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far
In this reporting period, the EDEN2020 consortium devoted a significant amount of effort to produce a steerable catheter system for use in convection enhanced drug delivery. As of the end of the reporting period, EDEN2020’s steerable catheter, which is inspired by the egg-laying channel of certain insects, is being produced at a size and with materials suitable for clinical use, featuring eight working channels for drug delivery, optical based theranostic modalities and shape sensing. It is complemented by an ecosystem of technologies to support agile delivery of pharmaceuticals to procedure-optimised targets within the brain. In the reporting period, progress has been made on state of the art, three-dimensional intraoperative ultrasound imaging; catheter shape sensing based on fibre brag gratings technology; advanced preoperative imaging based on state of the art MRI sequences; and a commercial front end, coupled with a state of the art stereotactic robotic system, both of which have been upgraded for use within EDEN2020. In period 1, the ethics behind the complex array of clinical trials on both human and ovine models starting in year 2 of the project was completed, and detailed experimental protocols were defined for each phase of the study. In period 2, the consortium made significant progress on all fronts: platform development, pre- and intra-operative imaging, image processing and sensorisation, and human and ovine clinical trials. The consortium delivered a family of pre-production steerable catheters within a bespoke blister pack, produced a complete robotic catheter driver, and a functional intelligent planner able to identify optimal curvilinear paths between a desired entry point and diffusion-modelling-based target pose. During the past 18 months, the consortium was also able to push forward with experiments employing a rigid catheter set, which is to provide a gold standard against which to compare the performance of the flexible needle. The project is supported by a comprehensive, user lead specification, which was meticulously put together borrowing from industrial R&D templates and practices, with a view to facilitating eventual commercial exploitation of EDEN2020’s outputs.
Progress beyond the state of the art, expected results until the end of the project and potential impacts
While the consortium expects to beat the state of the art on several fronts in subsequent periods, as of the end of this reporting period, progress on the steerable catheter delivery system has already exceeded what has been published in the literature. It is able to steer within full three dimensions without the need for an axial twist, it has been produced with the smallest cross-sectional diameter ever, and it now features two complete working channels per segments (eight in total), when only one working channel had been possible until now. With completion of this catheter’s development process, which is scheduled for Month 18 (i.e. September 2017), it is likely that significant interest can be generated to make use of its unique features to improve upon surgery, notably within the context of convection enhanced drug delivery for neurosurgical cancer therapy, which currently represents the consortium’s short term focus in EDEN2020.