CEREBROSPINAL FLUID MONITOR AND CONTROL SYSTEM FOR HYDROCEPHALUS

脑积水脑脊液监测和控制系统

• 批准号: 8323239
• 负责人: Kevin Martin Tangen
• 金额: $ 29.88万
• 依托单位: SYSTEMS SCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8323239
• 关键词: Accounting; Acute; Admission activity; Affect; Algorithms; Animal Model; Animals; Biomedical Engineering; Birth; Brain; Brain Diseases; Caring; Catheters; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Cessation of life; Childhood; Chronic; Clinical; Clinical Management; Clinical Treatment; Clinical Trials; Coagulation Process; Dependence; Development; Device or Instrument Development; Devices; Disease; Doctor of Philosophy; Drainage procedure; Electrodes; Electronics; Engineering; Equilibrium; Excision; Failure; Feedback; Goals; Health Care Costs; Hospital Charges; Hospitals; Hydrocephalus; Illinois; Implant; In Vitro; Intellectual Property; Laboratories; Lead; Legal patent; Liquid substance; Magnetism; Measurement; Measures; Medical; Medical Device; Methods; Modeling; Monitor; Neurosurgeon; Obstruction; Obstructive Hydrocephalus; Outcome; Patients; Performance; Phase; Positioning Attribute; Principal Investigator; Process; Pump; Research; Research Personnel; Science; Second Look Surgery; Shunt Device; System; Techniques; Technology; Testing; Time; Translating; Treatment Efficacy; United States; Universities; Validation; Ventricular; Vision; active control; analog; base; biomaterial compatibility; brain tissue; clinically relevant; design; digital; electric impedance; electrical property; experience; implantable device; in vivo; in vivo Model; innovation; novel; phase 1 study; pressure; sensor; technological innovation; treatment strategy

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.

描述(申请人提供)：在患有脑积水的患者中，脑脊液容量在大脑中异常积聚。每1000名新生儿中就有一人受到脑积水的影响，即每年有7万名患者。最常见的治疗方法包括植入一个带有被动差压阀的分流阀，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，医院在分流相关的儿科脑积水护理上花费了14亿美元。由于压力设置不充分，分流装置经常需要修改。不适当的设置可能会导致脑室引流过度或不足，如果不治疗可能会导致死亡。分流失败的另一个原因是阻塞，阻碍了液体的转移。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。这种大电导对比度可用于基于阻抗技术的活体测量脑室大小。系统科学公司将利用UIC研究人员开发的脑室容量传感器的现有知识产权，通过将该传感器与数字控制器和微泵集成来开发一种新型医疗设备。实施反馈将克服被动分流的缺点，从而为脑积水提供更好的治疗选择。目标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，并探索分流凝血的主动监测。生物相容性将通过体外和体内分析进行评估。在目标2中，我们将开发一种显示器以及微泵集成。监控系统将在台式模型上进行测试。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短期医院使用的急性系统。对于第二阶段，系统科学公司计划开发一种植入式设备，用于慢性患者的新型临床分流。该项目的愿景是开发一种主动闭环反馈系统。