Minimally Invasive Cerebral Blood Flow and Oxygenation Monitoring for Intracranial Hypertension

颅内高压的微创脑血流和氧合监测

• 批准号: 10443383
• 负责人: Thomas F. Floyd
• 金额: $ 181.48万
• 依托单位: UT SOUTHWESTERN MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-20 至 2026-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10443383
• 关键词: Acute; Awareness; Blood flow; Brain; Brain Injuries; Cerebral hemisphere hemorrhage; Cerebrovascular Circulation; Cerebrum; Computer software; Consult; Data; Development; Device Designs; Device Safety; Device or Instrument Development; Devices; Diagnosis; Diffuse; Dura Mater; Edema; Evaluation; Family suidae; Human; Intracranial Hypertension; Ischemia; Ischemic Stroke; Location; Magnetic Resonance Imaging; Measurement; Measures; Metabolic; Modeling; Modification; Monitor; Neurological outcome; Optics; Outcome; Oxygen; Oxygen saturation measurement; Patients; Performance; Population; Resolution; Safety; Secondary to; Sensitivity and Specificity; Skin; Spectrum Analysis; Spinal Cord Ischemia; Stroke; Surface; Surveys; System; Technology; Testing; Tissues; Translating; Trauma; Traumatic Brain Injury; Trephine hole; Validation; brain tissue; cerebral oxygenation; clinical efficacy; clinical translation; cranium; design; experience; feasibility testing; first-in-human; flexibility; gray matter; improved; improved outcome; minimally invasive; monitoring device; pre-clinical; preclinical study; prototype; regional difference; safety assessment; safety testing; survival outcome; tissue oxygenation; white matter

ABSTRACT/PROJECT SUMMARY Traumatic brain injury, acute ischemic stroke, and intracerebral hemorrhage are frequently complicated by intracranial hypertension leading to progressive ischemia and secondary brain injury. Recent efforts focused on improving outcomes have therefore been focused upon improving cerebral oxygenation and the development of monitoring devices to guide therapy. Current devices designed to measure tissue oxygenation are, however, severely limited in their scope of surveillance and accuracy. Surface oximetry monitors interrogate only superficial brain tissue, with contamination from intervening skin and skull. Intraparenchymal brain tissue oxygen probes survey relatively metabolically less active white matter (compared to gray matter), a volume of less than 3 mm3, and at a single location. Lastly, intraparenchymal tissue oxygen monitors are bulky, incompatible with magnetic resonance imaging, and have yet to demonstrate clinical efficacy. To fill this need, we will finalize the development of a brain-specific, minimally invasive, optical blood flow and oxygenation monitoring system (FLOXBR), then translate this device to humans. The FLOXBR, employing diffuse optical and correlation spectroscopies via a brain surface probe, may offer improved sensitivity and specificity compared to non-invasive probes and will probe larger volumes than currently available invasive probes, such as the LicoxTM tissue pO2 probe. Unlike intraparenchymal probes, this device can lie above or below the dura and will be more sensitive to highly metabolically active gray matter. Its small size and flexibility will permit multiple probes to be placed through a single burr hole, thus allowing for the monitoring of regional differences in flow and oxygenation. Unlike surface oximetry, the FLOXBR is not impacted by superficial trauma or edema, improving reliability and sensitivity. Continuous, easily interpreted, and reliable minimally invasive monitoring of cerebral oxygen delivery may enhance management and outcomes in patients suffering from intracranial hypertension. Our aims are succinctly summarized below. Aim 1) Finalize development & manufacture the FLOXBR brain flow and oximetry monitoring device. Aim 2) Pre-clinical device evaluation, measurement validation, and safety testing of FLOXBR. Aim 3) Complete regulatory and safety requirements to support FLOXBR first-in-humans feasibility testing. Aim 4) Conduct first-in-humans feasibility testing.

摘要/项目总结 创伤性脑损伤、急性缺血性卒中和脑出血经常并发于 颅内高压导致进行性缺血和继发性脑损伤。最近的工作重点是 因此，改善结果的重点是改善脑氧合， 开发监测设备以指导治疗。设计用于测量组织氧合的当前器械 然而，在监测范围和准确性方面受到严重限制。体表血氧监测仪 只检查表层脑组织，并受到皮肤和颅骨的污染。实质内 脑组织氧探头测量代谢相对较不活跃的白色物质（与灰质相比）， 体积小于3 mm 3，且位于单个位置。最后，脑实质内组织氧监测仪 体积大，与磁共振成像不相容，并且尚未证明临床疗效。 为了满足这一需求，我们将最终确定开发一种大脑特异性的，微创的，光学血流 和氧合监测系统（FLOXBR），然后将该设备应用于人类。FLOXBR，采用 通过脑表面探针的漫射光学和相关光谱学可以提供改进的灵敏度， 与非侵入性探头相比具有更高的特异性，并且将探测比目前可用的侵入性探头更大的体积 探针，如LicoxTM组织pO 2探针。与脑实质内探针不同，该装置可以位于脑实质上方或 在硬脑膜下面，并且将对高度代谢活性的灰质更敏感。其小巧的尺寸和灵活性 将允许多个探头通过单个钻孔放置，从而允许监测区域性 流量和氧合的差异。与表面血氧测定法不同，FLOXBR不受浅表创伤的影响 或水肿，提高可靠性和灵敏度。连续、易于解释且可靠的微创 监测脑氧输送可以提高患有脑缺血的患者的管理和结果。 颅内高压 我们的目标简明扼要地概述如下。 目标1）完成FLOXBR脑血流和血氧监测装置的开发和制造。 目的2）FLOXBR的临床前器械评价、测量确认和安全性测试。 目标3）完成监管和安全要求，以支持FLOXBR首次人体可行性测试。 目标4）进行首次人体可行性测试。