Adaptation and validation of a collaborative robotic equipment applied to Pediatric Neurosurgery

Objective Conception and validation of a collaborative robotic equipment for the neurosurgical treatment of pharmacoresistant epilepsy. Methods This is a methodological study in which an industrial equipment was adapted and validated for neurosurgical application. Realistic tests and simulations were performed on complex, patient-specific, three-dimensional models, both in the laboratory and in the surgical environment. Such validation followed the criteria established by the FDA manual for certification of medical devices. Results Precision tests analyzed the accuracy between the programmed and executed data, resulting in a mean error at the entry point of 2.21 mm and a target error of 4.41 mm. Discussion Comparative studies have pointed out the advantages of robotic over conventional surgeries, such as lower risk of bleeding, reduced surgical time, faster recovery, and excellent precision. Nevertheless, commercial challenges remain, mostly related to the high costs of software, hardware and maintenance of currently used robots. The device described herein could be an affordable option. Conclusion The KUKA IIWA SERIES® robot was adapted after successful simulations in the laboratory and Operation Room. The equipment was successfully tested, with trajectory errors within an acceptable margin, thus becoming a viable addition to enhance surgical precision. Future steps include approval by the respective government agency and further application in real operations.