In the last decades, the attention for surgical and therapeutic solutions based on minimally invasive approaches has been steadily growing. Robotics, artificial intelligence, simulation and modeling are helping to face technical difficulties generated by the limited access to the patient's internal organs. In this regard, robotics and image-guidance technologies contribute to increase precision and simplify surgical tasks. In the therapeutic scenario, Focused Ultrasound Surgery (FUS) is emerging as an early-stage, non-invasive, scarless technology which offers a disruptive, game-changing alternative to surgery, capable of complementing radiation therapy, drug delivery, and immunotherapy. Delivering large mechanical energy into deep tissues, without any harm for the tissues on the path, enables a plethora of therapeutic actions: tissue ablation/destruction, radiosensitization, vascular permeability, etc.

The aim of FUtuRo - Focused Ultrasound Surgery enabled by Robotics and Simulation is to boost the use of this novel solution for non-invasive surgery thanks to the incorporation of robotic guidance, image analysis, tissue modeling and extended reality. Although few examples of clinical FUS machines exist, the spread of this technology is still very limited and the execution is made difficult from the long training needed to understand, control and interpret the FUS phenomena.

The effect of FUS depends on intensity, frequency, duty cycle, mechanical and thermal properties of the target organ, as well as the characteristics of the interposed tissues. The temperature and the FUS effects (from mild thermal enhancement to cavitation) are not easy to interpret. In addition, without a pre-operative simulation and an intra-operative guidance, the efficiency and the safety of the procedure are compromised, and this is made even more complex when the target organ is moving, e.g., for breathing.

Starting from a first prototype of robotic FUS developed by the PI (Fig A.1), FUtuRo intends to make accessible, usable and easier to be translated into a wide clinical setting this therapeutic technology by:

• introducing a robotic control of the FUS source, for improving flexibility and autonomous control of the acoustic beam, making the overall procedure faster, and compensating for target motion;
• introducing an extended reality pre-operative planning to be registered with the operative scenario (i.e. FUS source and intraoperative images) to visualize the interactions and increase safety;
• simulating and pre-operatively visualizing the effects of FUS onto the target organs, including tissue deformation, thermal exchanges, cavitation phenomena, thanks to the integration of predictive modeling and intraoperative imaging;
• extensively assessing the developed technologies in-vitro and ex-vivo, and evaluating the system usability in a clinical setting by involving the final end-users (namely physicians) for fully demonstrating the FUtuRo potential and attracting both scientific and industrial interest.