Brain guard - a novel medical safety device

该项目是一项工业研究，旨在为一种新的低成本医疗设备获取关键知识，该设备将被称为Brain-Buddy。它有一种新型的传感器技术，如果大脑的引流管道(EVD)被中断，它会自动发出警报。在创伤或脑出血后或因其他原因(感染、脑积水)导致脑压升高的急性脑损伤患者中，EVDS提供了挽救生命的稳定。全世界每年有6900万人遭受脑损伤。每年，需要神经外科手术的病例有160万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，EVDS在治疗急性脑积水方面也有好处。每年大约有30,000例脑积水需要在HICs和740,000例在LMICs。我们相信Brain-Buddy将使患者受益匪浅，因为尽管对EVD进行了适当的维护和监测，但可能会出现高达54%的并发症，如梗阻和感染。重要的是及早发现堵塞，因为在早期阶段，用注射器或冲洗(用生理盐水或血液稀释剂)更有可能清除堵塞。此外，持续脑压高于40毫米汞柱与不良预后相关，脑压高于30毫米汞柱是较高短期死亡率的独立预测因素。研究表明，在患有创伤性脑损伤的成年人中，短暂的超过20毫米汞柱的37分钟的压力与6个月后的较低预后有关。这些潜在的破坏性后果加强了持续监测的必要性。目前市场上还没有设备可以在堵塞的情况下发出警报。有了Brain-Buddy，如果流量停止，护士将得到警报，不需要花费宝贵的时间连续观察系统。这笔拨款将支持对设备的潜力和局限性的关键调查。我们将在实验室对原型进行评估，看看它是否符合用户的要求。将根据战略价值/准入难易程度对市场进行评估。这笔拨款将使我们能够从战略上定位发明并完善我们公司的增长和扩张战略。该项目具有创新性，因为：*市场上没有这样的设备，*它通过自动向临床医生发出问题警报来降低患者的风险，而不是依赖于工作人员注意到液体流动已经停止，*Brain-Buddy的成本非常低，使其广泛负担得起。初步概念实验是成功的。

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.