Shanghai Ninth People's Hospital Unveils New Magnetic Field-Based Surgical Navigation Patent

Recently, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine has had one additional patent application published.This patent discloses a magnetic field-based surgical navigation method and system, which offers advantages including broad applicability, strong anti-interference performance, non-invasiveness to the human body, simple and convenient installation, elimination of the need for repeated assembly and disassembly, and high positioning accuracy.

According to publicly available data, the team fixed a magnet intraorally and acquired imaging data to establish an imaging coordinate system. Subsequently, a magnetic sensor array was configured to detect the magnet’s position, thereby forming a magnetic field coordinate system. The two coordinate systems were aligned based on the magnet’s position to construct a fused coordinate system, which was then used to redefine the coordinates of the surgical area, thus achieving precise localization.

Image-Guided Surgery (IGS) systems utilize medical imaging data, such as ultrasound, X-ray, CT, and MRI, to construct three-dimensional patient models, enabling surgeons to formulate surgical plans. Intraoperatively, real-time localization and tracking systems guide surgical maneuvers to ensure the precise execution of the planned procedure.

Surgical navigation systems typically consist of three components: an imaging module, a tracking module, and a display module. With advancements in multidisciplinary technologies such as computing, computed tomography (CT), and high-precision positioning and tracking systems, surgical navigation systems are continuously evolving toward greater precision, real-time performance, intelligence, compatibility, interactivity, and portability.

By Technology,Surgical navigation can be categorized into electromagnetic navigation systems, hybrid navigation systems, optical navigation systems, fluoroscopy-based navigation systems, CT-based navigation systems, and other technologies.. Medtronic’s AxiEM Stereotactic Navigation System primarily relies on electromagnetic tracking technology to measure the position and orientation of lesions within a magnetic field.

From the perspective of application scenarios,Although surgical navigation originated in neurosurgery, it has now permeated various departments, including spinal surgery (orthopedics), joint replacement (orthopedics), fracture reduction, intramedullary nail locking, otorhinolaryngology, plastic surgery, pulmonary diagnosis and treatment, labor monitoring, and interventional oncology.. Currently, the domestic surgical navigation market is mainly concentrated in the fields of neurosurgery and orthopedics.

In the orthopedics sector, Tinavi Medical Technologies has emerged with a market capitalization exceeding RMB 6 billion. Its TiRobot Recon Orthopedic Surgical Navigation and Positioning System is indicated for adult total knee arthroplasty.

Driven by its outstanding performance in surgical procedures, the market size for surgical navigation continues to expand. According to market data compiled by Bizwit Research & Consulting LLP, the global surgical navigation system market reached RMB 74.978 billion in 2022.

However, from a competitive perspective,Major players in the global surgical navigation system market include Medtronic, Brainlab, GE HealthCare, Stryker, and B. Braun, among others.The top five global manufacturers account for over 75% of sales market share, with North American production holding the largest market share.

China's surgical navigation system industry started relatively late. In 1997, the Department of Neurosurgery at Huashan Hospital Affiliated to Fudan University introduced the first Medtronic StealthStation surgical navigation system. It was not until two years later that Shenzhen Anke developed the first domestically produced surgical navigation system.

However, in 2006, “Research on Image-Guided Surgical Navigation Systems” was prominently listed among the research grant applications announced by the former Ministry of Health.Entrepreneurs have “sensed” the favorable signals from policy reforms, giving rise to a wave of leading domestic companies in the surgical navigation system sector, including Huake Jingzhun, Aimedi, Yida Jixing, Baihui Weikang, Dikai Er, and Ailifeng.

For example, AirMedi’s optical navigation device, Ruitong, which performs tracking and positioning based on binocular vision, achieves high-precision recognition of 0.1 millimeters by tracking optical markers. In 2022, Huake Jingzhun’s “Neurosurgical Navigation and Positioning System” received market approval for the navigation and directional positioning of neurosurgical instruments and implants.

As the number of market entrants increases, foundational technologies in the industry continue to evolve.In software development, Professor Tian Jie from the Institute of Automation, Chinese Academy of Sciences, has integrated medical image processing, analysis, and innovative technologies to establish a flexible and practical comprehensive computational framework. In terms of localization tools, Professor Zhang Fan’s team at Fudan University has developed a high-brightness azo-BODIPY brush-like macromolecular probe with excellent biosafety, which holds promise for applications in early tumor diagnosis and intraoperative navigation.