Chiurillo Isabella, Sha Raahil M, Robertson Faith C, Liu Jian, Li Jacqueline, Le Mau Hieu, Amich Jose M, Gormley William B, Stolyarov Roman
Zeta Surgical Inc., Boston, MA 02111, USA.
Department of Neurological Surgery, Massachusetts General Hospital, Boston, MA 02114, USA.
Bioengineering (Basel). 2023 Dec 7;10(12):1401. doi: 10.3390/bioengineering10121401.
For the past three decades, neurosurgeons have utilized cranial neuro-navigation systems, bringing millimetric accuracy to operating rooms worldwide. These systems require an operating room team, anesthesia, and, most critically, cranial fixation. As a result, treatments for acute neurosurgical conditions, performed urgently in emergency rooms or intensive care units on awake and non-immobilized patients, have not benefited from traditional neuro-navigation. These emergent procedures are performed freehand, guided only by anatomical landmarks with no navigation, resulting in inaccurate catheter placement and neurological deficits. A rapidly deployable image-guidance technology that offers highly accurate, real-time registration and is capable of tracking awake, moving patients is needed to improve patient safety. The Zeta Cranial Navigation System is currently the only non-fiducial-based, FDA-approved neuro-navigation device that performs real-time registration and continuous patient tracking. To assess this system's performance, we performed registration and tracking of phantoms and human cadaver heads during controlled motions and various adverse surgical test conditions. As a result, we obtained millimetric or sub-millimetric target and surface registration accuracy. This rapid and accurate frameless neuro-navigation system for mobile subjects can enhance bedside procedure safety and expand the range of interventions performed with high levels of accuracy outside of an operating room.
在过去三十年里，神经外科医生一直使用颅神经导航系统，为全球手术室带来了毫米级的精准度。这些系统需要手术室团队、麻醉，而最关键的是需要颅骨固定。因此，在急诊室或重症监护病房对清醒且未固定的患者紧急进行的急性神经外科疾病治疗，并未从传统神经导航中受益。这些紧急手术是徒手进行的，仅以解剖标志为导向，没有导航，导致导管放置不准确和神经功能缺损。需要一种能够快速部署的图像引导技术，该技术能提供高度准确的实时配准，并且能够跟踪清醒、移动的患者，以提高患者安全性。Zeta颅神经导航系统是目前唯一一款基于非基准点、经美国食品药品监督管理局（FDA）批准的神经导航设备，可进行实时配准和持续的患者跟踪。为评估该系统的性能，我们在受控运动和各种不利的手术测试条件下，对模型和人类尸体头部进行了配准和跟踪。结果，我们获得了毫米级或亚毫米级的靶点和表面配准精度。这种用于移动对象的快速、准确的无框架神经导航系统可以提高床边手术的安全性，并扩大在手术室之外高精度进行的干预范围。
