Using end-user feedback to optimize the design of the Versius Surgical System, a new robot-assisted device for use in minimal access surgery

Abstract

BackgroundRobot-assisted minimal access surgery (MAS) reduces blood loss, recovery time, intraoperative and postoperative complications and pain. However, uptake of robotic MAS remains low, suggesting there are barriers to its use. To overcome these barriers, a new surgical robot system, Versius, was developed based on the needs and feedback of surgeons and surgical teams.MethodsThe surgical robot prototype was designed based on observations in the operating room (OR) and previous interviews with surgeons. Formative studies with surgeons and surgical teams were used to refine the prototype design, resulting in modifications to all components, including the arms, instruments, handgrips and surgeon console. Proof-of-concept cadaver studies were used to further optimize its design by assessing its usability during surgical procedures.ResultsFeedback led to the development of a novel, mobile design with independent arm carts and surgical console, linked by supported serial or parallel connections, providing maximum flexibility in the OR. Instrument tips were developed based on surgeons’ preferred designs and wristed at the tip providing seven degrees of freedom within the patient. Multiple handgrip designs were assessed by surgeons; of these, a ‘game controller’ design was rated most popular and usable. An open surgical console design allowing multiple working positions was rated highest by surgeons and the surgical teams.ConclusionsThis surgical robot system has been developed using feedback from end users throughout the design process and aims to minimize barriers to robotic MAS uptake. Additionally, these studies demonstrate system success in the surgical procedures it was designed for. The studies reported here, and further studies of the Versius Surgical System, are intended to align with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework guidance.

Preclinical Evaluation of the Versius Surgical System, a New Robot-assisted Surgical Device for Use in Minimal Access Renal and Prostate Surgery

“…The console's head-up display relays the three-dimensional video from the endoscopic camera together with a display overlay. Its open design allows surgeons to sit or stand, and allows easier communication between the surgeon and the team, facilitating training and teaching [17]. The operating room (OR) team accesses controls and feedback on the visualisation BSU and up to three instrument BSUs, and views a two-dimensional version of the endoscope feed and display overlay on an auxiliary display ( Supplementary Fig.…”

“…The operating room (OR) team accesses controls and feedback on the visualisation BSU and up to three instrument BSUs, and views a two-dimensional version of the endoscope feed and display overlay on an auxiliary display ( Supplementary Fig. S1) [17]. The system's modular design increases its potential for flexible use, as the BSUs are small enough to be used in a standard OR and can easily be moved within a single OR or between ORs.…”

Preclinical evaluation of a new robot-assisted surgical system for use in gynecology minimal access surgery

“…The bedside team view a twodimensional version of the endoscope feed and display overlay via an auxiliary display on the visualisation bedside unit (BSU), and are able to access controls and feedback on up to four instrument BSUs. The BSUs are small enough to be used in a standard operating room (OR) and moved easily within a single OR and between ORs [16].…”

Interim safety analysis of the first-in-human clinical trial of the Versius surgical system, a new robot-assisted device for use in minimal access surgery

“…of MAS to patients with more complex pathology and higher body mass indices (BMI), allowing a wider range of patients to benefit from the advantages of MAS [11,13,14]. Furthermore, surgical robots can be designed to improve the experience of the surgeon and surgical team, enhancing both career longevity and surgical outcomes [15].…”

“…The Versius Surgical System is a new tele-operated robotic surgical system (CMR Surgical, Cambridge, UK) designed to assist surgeons in performing MAS. The surgical system was developed using feedback from surgeons and surgical teams, aiming to improve both end-user experience and surgical outcomes [15]. Specifically, Versius has been designed to mimic the articulation of the human arm, with the wristed instrument tip providing seven degrees of freedom inside the patient, allowing greater surgical access compared with standard laparoscopic surgery (Fig.…”