WP2 Surgical Method & System Architecture
The primary goal of WP2 is the study of the medical and technological background to define the FUTURA platform requirements and specifications. An in-depth technology analysis will focus on all aspects related to the robotic platforms that have the potential to meet the purpose of the project and to realize the medical requirements. The technological background work will analyze existing example of robots and robotic platform applications in surgery. The medical analysis will aim at providing optimal benchmarks for the robotic platform, to achieve its goals in surgical operation, from planning to monitoring and verification of the therapy. The medical background will focus on medical ultrasound and, more deeply, on the State of Art of Focused Ultrasound Surgery (FUS), and UltraSonography (US) guidance for monitoring therapy. It is clear that the work on the medical and technological background should proceed in parallel, in order to focus always and only on the technologies which are useful for FUTURA requirements and specifications.
Particular emphasis will be given to an Intellectual Property (IP) search, in order to understand and direct the development of novel devices toward market exploitation of results. The medical and technological background, relevant to the FUTURA objectives, will be exploited as guidelines for the design and the specification of the FUTURA system architecture. Within the framework of this WP a close collaboration between medical and technological partners will be of the utmost importance.
DESCRIPTION OF WORK
T2.1 Surgical robotics systems analysis - Activity includes a complete review of scientific publications in order to achieve a complete and wide knowledge related to existing robotic manipulators and platform for surgery. All the feasible solutions appearing in the most important specialized journals and in the fundamental research journals will be investigated and analyzed in order to choose the most suitable solution, e.g. the number of Degree of Freedom for the robotic manipulators, the robot kinematic etc. Results from recently funded EU projects will be considered as well, by exploiting the strong network of knowledge and relationship of the Consortium. Several commercial robotic platforms will be evaluated, in order to choose the most suitable solution to be adapted to FUTURA requirements. The aim of this Task is not a mere State of the Art but to highlight all those solutions that have the potential to be exploited in the FUTURA platform and that are not yet covered by fundamental patents.
T2.2 High Intensity Focused Ultrasound therapy analysis - Aim of Task 2.2 is to provide the optimal medical background for the robotic platform in order to achieve its real application in surgical operation. This Task will be focused on the State of Art of FUS, with an in-depth analysis on ultrasound physical principles. Furthermore the potential of diagnostic US to be exploited as a guidance monitoring of the therapy technology will be analyzed. The methods to be used in this Task comprise desk-research, the review of the scientific literature, clinical expert interviews and other professional means of scientific research.
T2.3 System specifications and regulatory procedures - Detailed description will be provided for all hardware and software parts, which need to be validated separately at first and then with updated software for assistance systems controlling. Definition will also contain the new embedded platform for validation of communication system and user interface. An important goal to be achieved is to define technological background, the regulatory and safety standards regarding EU medical standards like 93/42/EEC and ISO 13485. Proposal for classification and used rule according to Annex IX 93/42/EEC, proposal for UMDNS-Code setup and GMDN-Code setup will be recommended. Biocompatibility and Method of initial sterilization and Method(s) of reprocessing (cleaning, disinfection and sterilization by user) will be proposed.
Risk management will be planned according to EN ISO 14971:2012, IEC 60601-1-2 Ed. 3.0 b:2007 and EN ISO 60601-1-2, software safety classification will follow ISO 14971:2007. EN/IEC 60601-1 3rd edition will be used as guideline for usability.
In this Task, specification will be defined for the FUTURA platform manufacturing process to meet current EU regulatory, including list of the components used (Bill of Material) and analyses of critical components for manufacturing.
T2.4 Research about Relevant IP Right and Market Products - An extensive overview of patents related to the objectives and devised technological modules of FUTURA will be performed within this Task. This activity is fundamental for a proper management of IP risk. The sub-Tasks will be:
- patent and technology search;
- patent evaluation;
- product market search;
- IP-management strategy.