Light Robot for tele-operated needle insertion with compensation of physiological movements. – ROBACUS

Computed Tomography (CT) -guided insertion of a needle into a patient is a major issue (more than 600 000 procedures each year in USA), both for diagnosis (biopsies for cancers or abscesses) and for therapeutics (tumor destruction, abscesses drainage, …). The target cannot be reached in more than 10% of the cases, and it is too often necessary to introduce the needle more than once in order to reach the target (between 10 and 30% of cases, depending on difficulty). Besides, the procedure is long and multiplication of CT slices leads to irradiation. Finally, Magnetic Resonance Imaging (MRI) would often be able to provide more pertinent images to guide the action, but except for some neuroradiological MRI devices, guiding is not possible in classical MRI devices. With our robotic system, we plan to improve the diagnostic and therapeutic performances of CT-guided punctures, and to transform any MRI device into an interventional one, thus opening new clinical indications of MRI-guided punctures.

Based on the experience we gathered with a prototype of a “puncture-robot” that we already successfully tested on animals, we propose:1) to finalize a new version of a puncture-robot that can be operated both under CT and MRI; 2) to clinically operate this robot and to study its Expected Medical Added-Value on a small series of patients; 3) to optimize the control of this robot, exploiting a tele-operated architecture; 4) to study the feasibility of the detection and compensation of physiological movements of target organs.

The current prototype is close to clinical use, the blockages are here technical ones, and concern optimization of its robustness and precision, as well as incorporating potential evolutions that may become necessary after the risk-analysis required in order to obtain AFSSAPS’s agreement. Clinical use is a translational research work, where blockages consist in adapting to the specific case a methodology of demonstration of the Medical Added-Value Delivered by Computer Assisted Medical Interventions (CAMI) devices, to build the authorization applications requested by the People Protection Committee, AFSSAPS and HAS, then to record and interpret the data characterizing the clinical performance of the robot. The last two work-packages correspond to scientific and technological challenges which will allow to follow very closely the patient's movements and not only to reach targets in an even more robust and precise way, but also to open the field to new interventions.

The consortium we put together to take up these challenges groups tow laboratories specialized in medical robotics, one of which already built a first prototype whose operation enabled design of the new proposed architecture, the other one mastering the specific robotic issues corresponding to movement compensation. These two laboratories are associated to a Clinical Investigation Centre – Technological Innovation (in which works a specialist of Interventional Radiology experienced in CT-guided interventions), which is specialized in the demonstration of the Medical Added-Value Delivered by CAMI devices, together with an industrial partner who has a strong experience in designing and certifying medical robots. Industrial exploitation of the obtained results will be made easier by the close relationship with a startup-company specialized in “navigated” CT-guided punctures, for whom this robot comes as a natural extension of its offer to its network of interventional radiologists. Several patents have already been taken in order to protect this CT- or MRI-guided puncture robot, and new patents may have to be taken.