SBIR Phase II: Novel Device for monitoring brain hemorrhage using radio waves.

SBIR 第二阶段：使用无线电波监测脑出血的新型设备。

• 批准号: 1632270
• 负责人: Joseph Korfhagen
• 金额: $ 75万
• 依托单位: Sense Diagnostics, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2022-03-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1632270&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Novel; Device

The broader impact/commercial potential of this Small Business Innovation Research Phase II project is the reduction of deaths and long-term disabilities in people suffering from bleeding in the brain caused by intracerebral hemorrhage (ICH) or traumatic brain injury. Currently, physicians detect worsening bleeding through a clinical exam where a patient shows outward signs of deterioration in their neurological status. By the time these signs of additional bleeding appear, much of the damage to the brain has already occurred. About a third of people who suffer a severe traumatic brain injury either die or are left disabled. For hemorrhagic stroke, 60% die and 70% of survivors are left with significant disabilities. A device which transmits and receives very low power radiofrequency signals has been created that can be put on a patients head. The presence of blood outside of the brain's vessels and arteries creates a characteristic change in the radio signal used by the device. Using radio waves to non-invasively detect brain bleeds will allow treatment to start sooner, which will save lives, reduce disabilities and lower the cost of treating severe brain injuries.The proposed project tests (i) the ability of the device to detect and characterize small changes in ICH size and location over time and (ii) the ability to display changes in the bleed in a meaningful way to physicians. An algorithm for determining the size and location of the hemorrhage will be tested using both a phantom model that mimics the human brain and an IACUC-approved pig ICH model. Multiple hemorrhage volumes and locations will be used to test the algorithm's ability to detect hemorrhage volume changes within 1 mL, location within 1 cm, and distinguish changes due to the hemorrhage from physiological changes in a living pig's brain. Signal measurements taken before, during, and after infusion of blood will be captured at each time point to test the accuracy of the algorithm. Software will be developed to display the information from the algorithm in three-dimensions while giving doctors and nurses control over thresholds for triggering an alarm and how often the device scans. To test the software, the data collected during the pig experiments will be used to determine how accurate the display matches the location and size of the hemorrhage from CT images collected during testing.

这个小企业创新研究第二阶段项目的更广泛的影响/商业潜力是减少因脑出血（ICH）或创伤性脑损伤引起的脑出血而死亡和长期残疾的人。目前，医生通过临床检查发现出血恶化，患者在临床检查中表现出神经系统状态恶化的外部迹象。当这些额外出血的迹象出现时，大脑的大部分损伤已经发生。大约三分之一的严重创伤性脑损伤患者要么死亡，要么残疾。对于出血性中风，60%死亡，70%的幸存者留下严重残疾。一种发射和接收非常低功率射频信号的设备已经被制造出来，可以放在病人的头上。大脑血管和动脉外的血液会在设备使用的无线电信号中产生特征变化。使用无线电波来非侵入性地检测脑出血将允许治疗更早地开始，这将挽救生命，减少残疾并降低治疗严重脑损伤的成本。拟议的项目测试（i）该设备检测和表征ICH大小和位置随时间变化的能力，以及（ii）以有意义的方式向医生显示出血变化的能力。将使用模拟人脑的体模模型和IACUC批准的猪ICH模型测试用于确定出血大小和位置的算法。将使用多个出血体积和位置来测试算法在1 mL内检测出血体积变化、在1 cm内检测出血位置的能力，以及区分出血引起的变化与活体猪脑中的生理变化的能力。将在每个时间点采集血液输注之前、期间和之后的信号测量值，以测试算法的准确性。将开发软件来显示三维算法的信息，同时让医生和护士控制触发警报的阈值以及设备扫描的频率。为了测试软件，将使用猪实验期间收集的数据来确定显示与测试期间收集的CT图像中出血位置和大小的匹配程度。