SY-MIS Project: Biomedical Design of Endo-Robotic and Laparoscopic Training System for Surgery on the Earth and Space

Abstract

Despite the location (Earth or Space), surgical simulation is a vital part of improving technical skills and ensuring patients' safety in the real procedure. The purpose of this study is to describe the Space System for Minimally Invasive Surgery (SY-MIS©) project, which started in 2016 under the supervision of the Center for Space Systems (C-SET). The process connects the best features of the following machines: Biomedik Surgeon, Space Biosurgeon, SP-LAP 1, and SP-LAP 2, which were defined using the VDI 2221 guidelines. This research uses methods based on 3 standards: i) Biomedical design: ISO 9001-13485 / FDA 21 CFR 820.30 / ASTM F1744-96(2016); ii) Aerospace human factors: HF-STD-001; iii) Mechatronics design: VDI 2206. The results depict the conceptual biomedical design of a novel training system named Surgical Engineering and Mechatronic System (SETY©), which integrates the use of 2 laparoscopic tools and 2 anthropomorphic mini-robotic arms (6 DOF). It has been validated by the Evaluation of Technical Criteria, getting a total score of 90% related to clinical assessment, machine adaptability, and robustness. The novelty of the research lies in the introduction of a new procedure that covers the simultaneous use of laparoscopic and robotic systems, named Hybrid Cyber-Physical Surgery (HYS©). In conclusion, the development of SY-MIS© promotes the use of advanced technologies to improve surgical procedures and human-machine medical cooperation for the next frontier of habitability on other planets.