CEREBROSPINAL FLUID MONITOR AND CONTROL SYSTEM FOR HYDROCEPHALUS

描述（由申请方提供）：在脑积水患者中，脑脊髓液体积在脑内异常蓄积。脑积水影响每1,000名新生儿中的一名，即每年有70，000名患者。最常见的治疗方法包括植入一个带有被动压差阀的分流器，以排出多余的液体。对于儿科患者，这种治疗的失败率为50%。平均而言，医院在分流相关的小儿脑积水护理上花费了14亿美元。由于压力设置不足，分流管通常需要翻修。设置不当可能会导致脑室内引流过度或不足，如果不及时治疗可能导致死亡。分流失败的另一个原因是由于阻塞，阻塞了液体的分流。这些缺点需要一种完全不同的方法来治疗这种疾病。脑脊液的电特性与脑组织有很大的不同。这种大的电导率对比度可以用于基于阻抗技术在体内测量心室大小。系统科学公司将利用UIC研究人员开发的心室容积传感器的现有知识产权，通过将传感器与数字控制器和微型泵集成，开发一种新型医疗设备。反馈的实施将导致更好的治疗方案，脑积水，克服被动分流的缺点。目标1的目的是在台式模型上开发和测试由多个电极组成的导管系统。我们将评估传感器的位置依赖性，并探索分流凝血的主动监测。将通过体外和体内分析评估生物相容性。在目标2中，我们将开发一个显示器以及微型泵集成。监控系统将在台式模型上进行测试。将在脑积水动物模型中确认系统性能。这项I期研究的结果是短期住院使用的急性系统。对于第二阶段，系统科学公司。计划开发一种植入式设备，用于慢性病患者的新型临床转移。该项目的愿景是开发一个主动闭环反馈系统。 公共卫生相关性：脑积水是一种脑部疾病，目前的治疗方法是通过植入压差阀转移多余的脑脊液。这些分流经常需要手术翻修，导致每年10亿美元的国家医疗费用。本项目的主要目的是为脑积水患者研制一种脑容量监测和反馈控制系统。系统科学公司将首先为急性病人建立一个床边病房。在第二阶段，将开发用于患者慢性治疗的植入式系统。

DESCRIPTION (provided by applicant): In patients suffering from hydrocephalus, cerebrospinal fluid volume accumulates abnormally in the brain. Hydrocephalus affects one in 1,000 births, or 70,000 patients a year. The most common method of treatment consists of implanting a shunt with a passive differential pressure valve to drain the excess fluid. The failure rate of this treatment is 50% for pediatric patients. On average, $1.4 billion is spent by hospitals on shunt related pediatric hydrocephalus care. Shunts often require revisions due to an inadequate pressure setting. Improper settings may lead to over- or under-drainage of the brain ventricles, which can lead to death if untreated. Another reason for shunt failure is due to obstruction, which blocks the diversion of fluid. These shortcomings call for a completely differ approach to treating this disease. The electrical properties of cerebrospinal fluid differ substantially from brain tissue. This large conductivity contrast can be exploited to measure ventricular size in-vivo based on the impedance technique. Systems Science Inc. will capitalize on existing intellectual property on a ventricular volume sensor developed by the investigators at UIC to develop a novel medical device by integrating the sensor with a digital controller and micro-pump. The feedback implementation will lead to better treatment options for hydrocephalus by overcoming shortcomings of passive shunts. The objective of aim 1 is to develop and test the catheter system consisting of multiple electrodes on bench-top models. We will assess the positional dependence of the sensor and explore active monitoring of shunt coagulation. The biocompatibility will be assessed by in-vitro and in-vivo analysis. In aim 2, we will develop a display as well as micro-pump integration. The monitor and control system will be tested on bench- top models. The systems performance will be validated in hydrocephalic animal models. The outcome of this phase-1 study is an acute system for short-term hospital use. For phase-2, Systems Science Inc. plans to develop an implantable device for novel clinical diversions for chronic patients. The vision of this project is to develop an active closed loop feedback system. PUBLIC HEALTH RELEVANCE: Hydrocephalus is a brain disease currently treated by diverting excess cerebrospinal fluid by an implanted differential pressure valve. These shunts frequently require surgical revisions, resulting in $1 billion per year in national healthcare costs. The idea of this translational project is to manufacture a ventricular volume monitor and feedback control system for patients with hydrocephalus. Systems Science Inc. will initially develop a bedside unit for acute patients. In phase-2, an implantable system for chronic treatment in patients will be developed.