Non-Invasive Intracranial Pressure Monitor using Otoacoustic Emissions

描述（由申请人提供）：在本阶段I中，Koronis Biomedical Technology Corporation（KBT）拟开发和评价一种可提供无创、实时颅内压（ICP）监测的原型器械。申报器械将使用耳声发射（OAE）以听力测试的简单性测量ICP。颅内压监测在许多神经外科患者中至关重要。在急性病患者的管理中，明显需要持续的ICP真实的时间评估。现有的评估颅内压的方法都是有创的，并带有一些固有的风险。一种无创、准确、可重复的颅内压监测方法在这类患者中具有重要价值。最初的市场目标是一种评估工具，用于跟踪轻度和中度创伤性脑损伤（TBI）患者的ICP变化。目前，除了主观观察测试外，没有针对这些患者的评估工具。申报器械提供了一种可选的评估工具，当前的侵入性工具不可用或由于成本或患者风险而无法使用。 公共卫生相关性：对于轻度或中度创伤性脑损伤患者的评估工具存在重大需求。据估计，美国每年发生175万例TBI，相关的医疗保健费用估计为100亿美元。

DESCRIPTION (provided by applicant): In this phase I, Koronis Biomedical Technology Corporation (KBT) proposes to develop and evaluate a prototype device that provides non-invasive, real-time intracranial pressure (ICP) monitoring. The proposed device will measure ICP with the simplicity of a hearing testing using Otoacoustic Emissions (OAE). Monitoring of intracranial pressure is critically important in many neurosurgical patients. There is a clear need for ongoing real time assessment of ICP in the management of acutely ill patients. The existing methodologies for assessing intracranial pressure are all invasive and carry with them some inherent risks. A non-invasive, accurate, and re-producible method of following the intracranial pressure has great value in this patient population. The initial market is aimed at an assessment tool to track ICP changes for mild and moderate Traumatic Brain Injury (TBI) patients. Currently there are no assessment tools for these patients other than subjective observational tests. The proposed device provides an optional assessment tool where current invasive tools are not available or are prohibitive due to cost or risk to the patient. PUBLIC HEALTH RELEVANCE: There is significant need for an assessment tool for patients suffering from mild or moderate Traumatic Brain Injury. An estimated 1.75 million TBI's occur annually in the US with related health care costs estimated to be $10 billion.