Suzhou Institute of Biomedical Engineering and Huashan Hospital File Patent for Adaptive Real-Time Feedback Intracerebral Hematoma Evacuation Device

Intracerebral hemorrhage is the most severe form of stroke, with a mortality rate as high as 35% to 52% within the first 30 days after onset. Among these patients, only about 20% are able to regain independence in activities of daily living within six months. For patients with intracerebral hemorrhage, the longer the hematoma remains in the cranial cavity, the poorer the prognosis. Therefore, in neurosurgical practice, physicians typically employ minimally invasive procedures to evacuate the hematoma, thereby reducing compression and damage to the surrounding brain tissue.

Among various surgical approaches, endoscopic hematoma evacuation enables visualized procedures, and with the aid of neurointerventional instruments, neurosurgery has also entered the era of minimally invasive techniques. However, due to the lack of feedback on the extent of lesion removal in existing products, the completion of hematoma evacuation surgery relies heavily on the surgeon’s personal experience.

Recently, a joint initiative by the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences, and Huashan Hospital Affiliated to Fudan University"An Adaptive Real-Time Feedback Hematoma Evacuation Device and Method"Patent disclosure. This patent enables intelligent feedback and automatic control of hematoma evacuation extent, reducing variability in surgical techniques among different surgeons and ensuring consistency in cerebral hematoma evacuation procedures.

Hematoma evacuation for intracerebral hemorrhage primarily includes traditional craniotomy and minimally invasive hematoma evacuation. Traditional craniotomy is associated with prolonged operative time, significant trauma, and high requirements for equipment and technical expertise. Therefore,Minimally invasive hematoma evacuation has become the primary clinical treatment approach, gradually evolving toward visualization, intelligence, and personalization.

Professor You Chao from the Department of Neurosurgery, West China Hospital of Sichuan University, previously employed three methods to treat hypertensive intracerebral hemorrhage: microsurgical craniotomy, stereotactic aspiration and fragmentation, and endoscopic hematoma evacuation. The final results indicated that while stereotactic direct-view hematoma fragmentation and aspiration was associated with shorter operative time, less intraoperative blood loss, and minimal direct surgical trauma, it significantly increased the risk of postoperative rebleeding and intracranial infection.

In the concept of visualized surgery, physicians employ techniques such as neuroendoscopy and small bone window microscopy to evacuate hematomas under direct visualization, thereby improving hematoma clearance rates and reducing damage to surrounding brain tissue. In 2020, the neurosurgery team at Beijing Tsinghua Changgung Hospital (the First Affiliated Hospital of Tsinghua University) successfully performed a series of transcranial neuroendoscopic intraventricular hematoma evacuation procedures, achieving complete removal of intracranial hematomas under direct neuroendoscopic visualization.

In the context of “intelligent, personalized” surgery, physicians can achieve visualization of needle puncture with real-time feedback through artificial intelligence and machine learning technologies. Furthermore, this surgical concept enables multimodal perceptual fusion and precise control of the intracranial environment, while establishing a big-data platform for clinical treatment to assist physicians in formulating individualized plans for hematoma evacuation and drainage.

Concurrently, surgical instruments have also been upgraded alongside the evolution of surgical techniques.However, from an overall perspective, most medical devices currently on the market have met the requirements for visualization and minimally invasive techniques in hematoma evacuation procedures, while no products addressing intelligence and personalization have yet been launched.

In the research and development of minimally invasive and visualization equipment, MicroPort NeuroTech launched the Apollo System as early as 2004. This system enables gentle and rapid aspiration of tissues and fluids while minimizing the risk of channel clogging. Additionally, Wantefu Medical has developed the WTF-I Type Auxiliary Locator for Minimally Invasive Evacuation of Intracranial Hematomas. Designed based on the “two points, one line” principle, this locator facilitates the minimally invasive evacuation of hematomas.

In 2020, Professor Sun Shujie from the Department of Neurosurgery at Xuhui Hospital Affiliated to Zhongshan Hospital, Fudan University, unveiled a visual drainage catheter system. The system comprises a visual catheter tip, a catheter body, and an endoscope, enabling physicians to perform catheter insertion with the same convenience and direct visualization as endoscopic surgery. This innovation helps avoid blind puncture during catheter placement and reduces reliance on clinicians’ experience.

In the realm of intelligent and personalized device development, Wantefu Medical unveiled an intelligent system for intracranial hematoma evacuation and drainage in 2019. This system comprises an information input module, an information detection module, an intelligent processing module, and a hematoma evacuation and drainage module. It not only ensures that all therapeutic procedures are evidence-based but also enables real-time signal monitoring, thereby facilitating continuous real-time tracking of critical patient data during intracranial hematoma treatment and enhancing surgical controllability and precision.

In 2022, Professor Ji Ruijun from Beijing Tiantan Hospital developed a novel emergency device and service system that integrates intelligent minimally invasive hematoma evacuation with dynamic local monitoring for intracerebral hemorrhage. This system provides key pathophysiological information, thereby enhancing the efficacy and efficiency of hematoma clearance and improving clinical outcomes for patients. The device is currently still under development.