CEREBROSPINAL FLUID MONITOR AND CONTROL SYSTEM FOR HYDROCEPHALUS

描述（由申请人提供）：脑积水患者，脑脊液量在脑内异常积聚。每1000名新生儿中就有1人患有脑积水，每年有7万人患有脑积水。最常见的治疗方法是植入一个带被动压差阀的分流器来排出多余的液体。对于儿科患者，这种治疗的失败率为50%。医院平均花费14亿美元用于分流相关的小儿脑积水护理。由于压力设置不足，分流经常需要修正。不适当的设置可能导致脑室引流过度或不足，如果不治疗可能导致死亡。分流失败的另一个原因是由于阻塞，阻塞了流体的转移。这些缺点要求采用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可以利用阻抗技术来测量体内心室大小。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。反馈的实施将通过克服被动分流的缺点，为脑积水提供更好的治疗选择。目的1的目标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，并探索主动监测分流凝血。生物相容性将通过体外和体内分析进行评估。在目标2中，我们将开发显示和微泵集成。监控系统将在台架模型上进行测试。该系统的性能将在脑积水动物模型中得到验证。这项1期研究的结果是一种用于医院短期使用的急性系统。对于第二阶段，系统科学公司计划开发一种用于慢性患者的新型临床转移的植入式装置。该项目的愿景是开发一个主动闭环反馈系统。

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.