Domestic Full-Field Intelligent Exoscope Team Poised to Usher in a New Era of Visualized Surgery

Human eyes are hailed as “miracles of design,” with their intricate structures enabling us to explore, perceive, and understand the world. However, the human eye has limitations in perceiving the microscopic realm.

Microscopes possess magnification capabilities that enable humans to explore realms beyond the reach of the naked eye. Throughout the more than 100-year history of modern neurosurgery, microscopes have played a pivotal role. In recent years, however, new visualization technologies have emerged, including high-definition/ultra-high-definition video microscopy systems, 2D/3D endoscopes, and next-generation microscopes. In 2008, exoscope technology was introduced, becoming the latest addition to the neurosurgeon’s arsenal.

The application of surgical exoscopes has already reached a considerable scale abroad, whereas in China, it remains in the trial and promotion stages and relies primarily on imports.

At the VB-Link Future Healthcare Specialty Innovation Solutions Challenge, hosted by VCBeat and VB100, the R&D team behind the surgical exoscope was also present. In the Hangzhou division held in June 2023, a team developing a full-view intelligent neurosurgical exoscope system, recommended by the Neurosurgery Innovation and Translation Branch of the China Health Care Association for the Elderly, stood out from the competition and won the “Most Commercially Valuable Award.” To this end, Chengguo Bureau interviewed Dong Miao, the team leader, to gain insights into the development history of surgical exoscopes, the domestic and international markets, and the development roadmap for their domestically produced surgical exoscope.

Dong Miao, Head of the R&D Team for the Full-View Intelligent Neurosurgical Exoscope System

Conventional surgical microscopes have been in clinical use for nearly 20 years. Over this period, the overall functional architecture of these microscopes has remained largely unchanged, with upgrades primarily focused on performance enhancements and multifunctional capabilities. Examples include improvements in lens clarity and integration of features such as increased depth of field.

Nevertheless, the core structural framework of the microscope has remained unchanged, resulting in the persistence of certain operational limitations during neurosurgical procedures. Specifically, these issues are primarily manifested in the following aspects:

First, there are limitations in the field of view. The visual perspective provided by a microscope has certain deficiencies; it can only capture the area within its designated field of view. Regions with curvature or angles fall into the microscope's blind spots.

Secondly, microscopes have deficiencies in ergonomic design. Microscopes require the surgeon to observe the surgical field through fixed eyepieces. This forces the surgeon to maintain a bent neck and body posture for prolonged periods during the procedure, leading to discomfort and fatigue, which can adversely affect surgical outcomes.

Finally, there is a lack of intelligent automation. The operation of microscopes is not sufficiently automated; during use, physicians must use one hand to adjust the lens while using the other to stabilize the area being operated on. Given the weight of the microscope, this imposes considerable operational difficulty for physicians.

It is precisely due to these limitations that endoscopy has gradually gained popularity. The advantage of endoscopy lies in its ability to directly bypass certain shields and obstacles to reach the target surgical area. However, endoscopy also has certain drawbacks. Its imaging is two-dimensional, and the endoscope shaft is long and remains positioned within the surgical channel throughout the procedure. The shaft not only obstructs surgical maneuvers but also must be kept extremely stable at all times. Any movement of the shaft during surgery can easily damage surrounding nerves and blood vessels. Since the camera lens is located at the distal tip while the shaft extends posteriorly, surgeons may fail to promptly recognize such injuries.

In response to the limitations of surgical microscopes and neuroendoscopes in clinical applications, exoscopic surgery systems have emerged. Compared with endoscopes, exoscopes offer multi-angle visualization of the surgical field, with cameras capable of rotating to various angles, thereby covering all areas accessible to both microscopes and endoscopes. Through the integration of intelligent features, such as voice control and visual navigation technologies, these systems not only ensure the continuity of the surgical procedure but also enhance surgical efficiency and success rates.

Secondly, the ergonomic design of the exoscope is also advanced. Surgeons can freely adjust the angle of the exoscope and perform surgical procedures by viewing a fixed-position display, thereby avoiding prolonged neck and body flexion and significantly reducing surgeon fatigue.

Finally, the continuously improving depth and precision of exoscope lenses further ensure surgical safety.

“The exoscope, which evolved from the microscope while overcoming many of the limitations associated with endoscopes, is a surgical instrument worthy of widespread adoption,” summarized Dong Miao.

Abroad, the application of surgical exoscopes has already reached a significant scale. Nearly all renowned neurosurgery centers and mainstream hospitals are equipped with surgical exoscopes.

In contrast, the application of surgical exoscopes in China is just beginning and remains in the stage of clinical promotion and trial use. Dong Miao revealed that nearly 20 neurosurgery centers at Grade A tertiary hospitals across China have already adopted exoscope systems.

However, from the manufacturer's perspective, surgical exoscopes currently used in China still rely mainly on imports, with each unit priced as high as RMB 3 to 5 million. This prohibitive cost further limits the clinical adoption of these devices. Therefore, Dong Miao believes that the localization of surgical exoscope production in China is urgently needed.

To this end, Dong Miao’s team aims to catch up with and ultimately surpass foreign advanced technologies during the process of introducing them, thereby enabling the reverse export of domestically produced medical devices. He also presented a cost analysis to Chengguo Bureau, demonstrating that through localization, the price of surgical external viewing systems could be reduced to approximately RMB 1 million or even lower. This price point falls precisely within the RMB 1 million threshold set by county-level cities across China for the procurement of major domestically produced medical equipment, thereby facilitating the promotion of Chinese-made external viewing systems in major hospitals nationwide, including grassroots healthcare institutions.

In the “1+X” framework, “1” refers to the surgical external viewer, representing the foundation, while “X” denotes an open-source platform. The original intention of Dong Miao’s team in developing a domestically produced surgical external viewer was to create an open-source platform for such devices. This platform aims to integrate advanced technologies from other companies based on their self-developed external viewer, gradually realizing a real-time and user-friendly visualized surgical operation platform.

It has been revealed that the surgical external visualization system currently under development by the team has been basically realized, and plans are underway to collaborate with various partners across the cooperation chain.

In addition to laying a solid foundation for the surgical external viewer, the team also undertook other preparatory work. For instance, it has established robust technical reserves in visual navigation and AR/VR visualization navigation based on real-time image feedback. These technologies can be seamlessly integrated into the surgical external viewer, creating a comprehensive, end-to-end visualized surgical operation platform.

Technology drives medical advancement. With the continuous emergence of new visualization technologies, Dong Miao’s team will further explore scientific research opportunities, gradually integrating the latest findings into the “X” component of the “1+X” framework to enhance and refine the surgical external vision system.

The development, design, and clinical application of surgical exoscopes involve numerous technical details, an area where China currently still faces gaps.

Fortunately, the transition toward full-scale industrialization does not rely on a single point, but rather on the entire industry chain.

Furthermore, the team has consolidated insights from numerous experts across China to establish a comprehensive clinical knowledge repository. Through such resource integration, the external visualization system can undergo continuous upgrades and iterations.

On one hand, we collaborate with university research teams; on the other, we partner with innovative technology companies across the exoscope system industry chain. Through this diversified “industry-clinical-research” collaboration model, we reduce the costs of independent development and mitigate the risks associated with product commercialization.

Following the VB-Link Challenge, Dong Miao informed VCBeat that the project has already attracted significant attention from investors and is actively advancing collaborations with several well-known domestic investment firms to secure and accumulate financial support for its future development. The team has currently completed several relevant animal studies, plans to submit the clinical trial registration application by the first half of 2024 at the latest, and expects to obtain marketing approval before June 2025.

Dong Miao revealed that the team hopes to expand the application of the surgical external vision system from brain tumor surgeries to other neurological procedures, while achieving further breakthroughs in multidimensional external vision technology.

Currently, the team’s developed prototype of the external visualization system is not only applicable in neurosurgery but also holds broad application prospects in general surgery, cardiothoracic surgery, and hepatobiliary surgery. The introduction of these products is expected to provide patients with more efficient and safer solutions, advance the development of surgical procedures in China, and represent a new breakthrough in achieving visualized surgical techniques.