A robotic system for solo surgery in flexible ureteroscopy: development and evaluation with clinical users

摘要

PURPOSE: The robotic system CoFlex for kidney stone removal via flexible ureteroscopy (fURS) by a single surgeon (solo surgery, abbreviated SSU) is introduced. It combines a versatile robotic arm and a commercially available ureteroscope to enable gravity compensation and safety functions like virtual walls. The haptic feedback from the operation site is comparable to manual fURS, as the surgeon actuates all ureteroscope DoF manually. METHODS: The system hardware and software as well as the design of an exploratory user study on the simulator model with non-medical participants and urology surgeons are described. For each user study task both objective measurements (e.g., completion time) and subjective user ratings of workload (using the NASA-TLX) and usability (using the System Usability Scale SUS) were obtained. RESULTS: CoFlex enabled SSU in fURS. The implemented setup procedure resulted in an average added setup time of 341.7 ± 71.6 s, a NASA-TLX value of 25.2 ± 13.3 and a SUS value of 82.9 ± 14.4. The ratio of inspected kidney calyces remained similar for robotic (93.68 %) and manual endoscope guidance (94.74 %), but the NASA-TLX values were higher (58.1 ± 16.0 vs. 48.9 ± 20.1) and the SUS values lower (51.5 ± 19.9 vs. 63.6 ± 15.3) in the robotic scenario. SSU in the fURS procedure increased the overall operation time from 1173.5 ± 355.7 s to 2131.0 ± 338.0 s, but reduced the number of required surgeons from two to one. CONCLUSIONS: The evaluation of CoFlex in a user study covering a complete fURS intervention confirmed the technical feasibility of the concept and its potential to reduce surgeon working time. Future development steps will enhance the system ergonomics, minimize the users' physical load while interacting with the robot and exploit the logged data from the user study to optimize the current fURS workflow.