Non-Invasive Intracranial Pressure Monitor using Otoacoustic Emissions

描述(由申请人提供)：在这一阶段，Koronis Biomedical Technology Corporation(KBT)建议开发和评估一种提供非侵入性、实时颅内压(ICP)监测的原型设备。建议的设备将测量颅内压，使用耳声发射(OAE)听力测试的简单性。对许多神经外科患者来说，监测颅内压至关重要。在对危重病人的管理中，显然有必要持续实时评估颅内压。现有的评估颅内压的方法都是侵入性的，并带有一些固有的风险。一种非侵入性的、准确的、可重复的跟踪颅内压的方法在这一人群中具有重要的价值。最初的市场目标是一种评估工具，用于跟踪轻、中度创伤性脑损伤(TBI)患者的颅内压变化。目前，除了主观观察性测试外，还没有针对这些患者的评估工具。建议的设备提供了一种可选的评估工具，在目前无法获得或由于患者的成本或风险而无法使用的情况下。 公共卫生相关性：对于患有轻度或中度创伤性脑损伤的患者来说，非常需要一种评估工具。据估计，美国每年发生175万例脑损伤，相关的医疗成本估计为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.