Brain guard - a novel medical safety device

这个项目是一项工业研究，目的是为一种新的低成本医疗设备获取关键知识，这种设备将被称为Brain-Buddy。它有一种新颖的传感器技术，如果大脑引流管（EVD）的流量被中断，它会自动发出警报。evd可为创伤或脑出血后急性脑损伤患者或因其他原因（感染、脑积水）导致脑压升高的患者提供挽救生命的稳定。全世界每年有6900万人遭受脑外伤。每年有160万例需要进行神经外科手术的病例发生在高收入国家，450万例发生在中低收入国家。除了创伤外，evd在治疗急性脑积水方面也有好处。高收入国家每年约有3万例脑积水需要神经外科手术，低收入国家每年约有74万例脑积水需要神经外科手术。Nvention相信，Brain-Buddy将给患者带来极大的好处，因为尽管对EVD进行了适当的维持和监测，但高达54%的患者可能会出现阻塞和感染等并发症。早期发现堵塞是很重要的，因为在早期，用注射器轻轻抽吸或冲洗（用生理盐水或血液稀释剂）更有可能清除堵塞。此外，持续高于40mmHg的脑压与预后不良相关，高于30mmhg的脑压是短期死亡率较高的独立预测因子。研究表明，创伤性脑损伤成人6个月时，血压高于20mmHg的短时间仅需37分钟，其预后就会较低。这些潜在的破坏性后果加强了持续监测的必要性。目前市场上还没有一种设备可以在堵塞时发出警报。有了Brain-Buddy，护士会在血流停止时收到警报，不需要花宝贵的时间持续观察系统。这笔拨款将支持对设备的潜力和局限性进行批判性调查。我们将在实验室对样机进行评估，看它是否符合用户的要求。将根据战略价值/进入的便利性对市场进行评估。这笔赠款将用于战略性定位发明和完善我们公司的增长和扩张战略。这个项目的创新之处在于：*市场上还没有这样的设备，*它通过自动提醒临床医生出现问题来降低患者的风险，而不是依靠工作人员注意到流体已经停止流动，* Brain-Buddy的成本非常低，使其广泛负担得起。概念验证实验是成功的。

This project is industrial research to gain critical knowledge for a new low-cost medical device which will be called the Brain-Buddy. It has a novel sensor technology that automatically alerts if flow in drainage lines (EVD) from the brain is interrupted. EVDs provide lifesaving stabilization in patients with acute brain injury after a trauma or brain bleed or when the brain pressure rises for other causes (infection, hydrocephalus). Each year 69 million individuals worldwide suffer a brain trauma. Annualy, 1.6 million cases requiring neurosurgery occur in high-income countries, 4.5 million occur in lower-middle-income countries. In addition to trauma, EVDs also provide benefits in the treatment of acute hydrocephalus. There are approximately 30,000 cases of hydrocephalus requiring neurosurgery in HICs and 740,000 cases in LMICs per year.Nvention believe the Brain-Buddy will highly benefit patients as, despite appropriate maintenance and surveillance of an EVD, complications such as obstruction and infection may arise in up to 54%.It is important to detect a blockage early as, in the early stage, gentle aspiration with a syringe or flushing (with saline or blood thinners) is more likely to clear the blockage. Also, sustained brain pressure above 40mmHg is associated with poor outcome, brain pressure above 30 mmHg is an independent predictor of higher short-term mortality. Research studies showed that brief periods of as little as 37minutes of pressure above 20mmHg are associated with lower outcomes at 6 months in adults with traumatic brain injury. These potentially devastating consequences reinforce the need for continuous monitoring. There is currently no device on the market to alarm in case of a blockage. With the Brain-Buddy, nurses will be alerted if flow stops and do not need to spend their valuable time continuously watching the system.This grant will support the critical investigation of the devices' potential and limitations. We will evaluate the prototype in the laboratory to see if it meets user requirements. The market will be assessed regarding strategic value/ease of access. The grant will allow strategically position of Nvention and refining our company growth and expansion strategy.The project is innovative as:* there is no such device on the market,* it lowers risk to patients by automatically alerting the clinician of a problem, rather than relying on staff noticing that fluid flow has stopped,* the Brain-Buddy is exceptionally low cost, making it widely affordable.Proof of concept experiments were successful.