Abstract: BACKGROUND: Conventional percutaneous CT-guided interventional puncture cannot be monitored in real time, and the operation takes a long time. In some high-risk puncture sites, multiple CT scans and adjustments to the position of the puncture needle are required, causing greater radiation damage to the patient. A self-developed surgical navigation and positioning system provides an effective way to solve the clinical problems of percutaneous puncture information perception and accurate and safe target puncture in complex intraoperative environments, achieving precise puncture positioning of the chest and abdomen.
OBJECTIVE: To evaluate the safety, effectiveness and usability of the self-developed percutaneous puncture navigation robotic system in clinical application.
METHODS: A retrospective analysis was conducted on clinical trial data from percutaneous lung nodule biopsy and tumor ablation procedures guided by a puncture navigation robotic system at the First Affiliated Hospital of Guangzhou Medical University and the Second Affiliated Hospital of Soochow University between November 1, 2021 and June 28, 2022. A multicenter, open-label, parallel controlled clinical study was conducted, and 120 subjects were randomly divided into an experimental and a control group, with 60 subjects in each group. The experimental group underwent puncture guided by a puncture navigation robotic system, while the control group underwent percutaneous puncture solely under CT guidance. The safety, efficacy, and usability of the puncture navigation robotic system was evaluated based on primary effectiveness indicators (puncture accuracy rate), secondary indicators (the number of needle adjustments during surgery, single-attempt success rate of puncture procedures, number of CT scans required, and usability of the system).
RESULTS AND CONCLUSION: No unsafe incidents occurred throughout the entire clinical trial using the puncture navigation robotic system to guide puncture. The single-attempt success rate of puncture procedures was 98.31%, and the incidence of complications was 6.78%. The single-attempt success rate of puncture procedures in the control group was 15.00%, and the incidence of complications was 13.33%. The usability satisfaction rate of the system was 100%, achieving the interactive modeling and manipulation of the puncture needle and soft tissue, the dynamic reconstruction of the complex environment of the surgical area and the real-time perception of puncture information, and the dynamic navigation and tracking compensation under the interaction between physiological motion and puncture. Robotic navigation and safe and accurate puncture guided by multi-modal medical images for various soft tissue organs have been realized, providing an effective way to solve the clinical challenges of information perception and precise and safe puncture of target sites during percutaneous puncture in complex intraoperative environments.

Key words: robot, navigation system, percutaneous puncture, minimally invasive, pulmonary nodule, clinical application