Real-time Cerebral Blood Flow Monitoring System

描述（由申请人提供）：本项目的目的是开发一种微创和多模式神经外科监测系统，能够连续和真实的同时测量脑血流量（CBF）和颅内压（ICP）。这种创新的方法将联合收割机的测量模式与脑脊液（CSF）的能力相结合，以控制ICP与同一设备。在美国，每年有370，000起创伤性脑损伤（TBI）事件和100，000起随后的死亡事件。损伤是由原发性创伤和随后由活组织中的局部缺血（血液供应不足）引起的继发性损伤引起的。监测和介入治疗以防止继发性损伤，试图通过将ICP控制在阈值水平以下来维持存活组织的足够水平的CBF。虽然在实践中通常不监测CBF，但ICP用于间接评估缺血风险。CBF的直接、实时和连续监测将有助于指导治疗，为缺血、血管痉挛和神经生理学恶化提供早期预警，允许定制患者特定的治疗，并有助于了解神经生理学。对于神经外科医生来说，在床边测量CBF一直是期望和追求的。 在第二阶段，将设计和开发多模式微创和仪器化脑室导管。此外，将开发多模式监测器和相关软件，并在一系列头部受伤患者的研究中使用。将开发定制颅内通路硬件，以便于将导管导入脑组织。监视器将有一个彩色LCD显示屏和一个直观的用户界面。CBF和ICP将以数字和图形形式连续、真实的显示。将进行一系列临床研究以监测创伤性损伤或蛛网膜下腔出血患者的CBF。本研究的目的是确认CBF和ICP监测作为临床相关事件的早期预警的高水平临床价值。

DESCRIPTION (provided by applicant): The objective of this project is to develop a minimally invasive and multimodal neurosurgical monitoring system that is capable of simultaneously measuring cerebral blood flow (CBF) and intracranial pressure (ICP) continuously and in real time. This innovative approach will combine the measurement modalities with the ability to drain cerebrospinal fluid (CSF) to control ICP with the same device. Each year in the U.S. there are 370,000 incidents of traumatic brain injury (TBI) and 100,000 subsequent deaths. Injury results from a primary trauma and a later secondary injury caused by local ishemia (deficient blood supply) in viable tissue. Monitoring and interventional therapies to prevent secondary injury attempt to maintain an adequate level of CBF to viable tissue by controlling ICP below a threshold level. While in practice CBF is not typically monitored, ICP is used to indirectly assess ischemic risk. Direct, real-time and continuous monitoring of CBF will help guide therapy, provide an early warning for ischemia, vasospasm, and neurophysiologic deterioration, allow customization of patient-specific therapy and help understand neurophysiology. For the neurosurgeon, the measurement of CBF at the bedside has been long desired and sought after. In Phase II, the multimodal minimally invasive and instrumented ventricular catheter will be designed and developed. Also, the multimodal monitor and associated software will be developed and utilized in a series of studies with head-injured patients. Custom intracranial access hardware will be developed to facilitate the introduction the catheter into cerebral tissue. The monitor will have a color LCD display and an intuitive user interface. CBF and ICP will be displayed in numerical and graphical form continuously and in real time. A series of clinical studies will be performed to monitor CBF in patients with traumatic injury or aneurismal subarachnoid hemorrhage. The aim of this study is to confirm the high level of clinical value CBF and ICP monitoring has as an early warning of clinically relevant events.