CEREBRAL BLOOD FLOW MONITORING SYSTEM

长期目标是开发一种实时、连续的临床绝对脑血流量（CBF）监测仪。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，以防止二次损伤的尝试，以保持足够水平的CBF活组织。 虽然在实践中通常不监测CBF，但颅内压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。在第一阶段，将在猪脑中对微球金标准进行血流（灌注）测量的创新热方法进行验证。这种热技术已被验证用于测量肝组织中的血流量，并且它作为一种真实的实时连续监测患者CBF的技术具有很大的前景。同样在第一阶段，将开发一种MRI兼容的神经外科探头。将在体内测试探头的灌注灵敏度及其量化组织含水量（水肿）微小变化的能力。拟议的商业应用：美国每年有超过37万人因创伤性脑损伤（TBI）住院，全国每年约有10万人死亡。与TBI相关的总成本估计为每年483亿美元：317亿美元与住院治疗相关，166亿美元与致命性脑损伤相关。患有蛛网膜下腔出血、血管痉挛、脑肿瘤和中风的患者也有缺血的风险。所提出的用于连续地、真实的时间地量化血流的低成本设备将对这些严重受伤患者的改善管理产生显著影响，超过目前使用的脑血流的间接指标。

The long-term objective is to develop a real-time, continuous, clinical monitor of absolute cerebral blood flow (CBF). 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 ischemia (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. While in practice CBF is not typically monitored, intracranial pressure 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. In Phase I, an innovative thermal method for blood flow (perfusion) measurement will be validated in swine brain against the microsphere gold standard. This thermal technique has been validated for the measurement of blood flow in liver tissue and it holds great promise as a technique to continuously monitor patient CBF in real time. Also in the Phase I, an MRI compatible neurosurgical probe will be developed. The probe will be tested in vivo for perfusion sensitivity and for its ability to quantify small changes in tissue water content (edema). PROPOSED COMMERCIAL APPLICATIONS: Over 370,000 people in the US are hospitalized for traumatic brain injury (TBI) each year and about 100,000 deaths occur per year, nationally. The total cost associated with TBI is estimated to be $48.3 billion annually: $31.7 billion associated with hospitalization and $16.6 billion associated with fatal brain injuries. Patients with subarachnoid hemorrhage, vasospasm, brain tumors and stroke are also at risk for ischemia. The proposed low cost device to quantify blood flow continuously, in real time will have significant impact on the improved management of these critically injured patients over and above the currently used, indirect indicators of cerebral blood flow.