Ambulatory System for Hydrocephalus Shunt Monitoring

描述（由申请人提供）： 在美国，每年有超过10，000名新生儿被诊断患有脑积水。脑积水是一种脑脊髓液（CSF）在头部过度积聚的疾病，是一种终身疾病，目前尚无治愈方法。幸运的是，脑积水可以通过脑脊液分流术来治疗，将过多的脑脊液转移到身体的其他地方。不幸的是，30-40%的分流器在第一年就失败了，堵塞是最常见的原因。因此，为了降低持续永久性脑损伤或失明的风险，快速诊断分流失败至关重要。目前检测分流失败的协议是耗时和昂贵的，因为它依赖于症状诊断，脑扫描和经皮分流攻丝。因此，我们的最终目标是开发一种可以在没有脑部扫描和侵入性手术的情况下快速检测分流失败的流动系统，从而改善患者的预后并降低医疗成本。为了实现这一目标，分流器将安装微型压力传感器，这些传感器是可植入的，在体外无线通信，并且不需要电池。传感器采用创新的包装技术策略性地放置在分流管中，因此不需要额外的侵入性外科手术进行植入。无线通信通过手持读取器和传感器之间的低功率（微瓦）互感耦合来执行。在成功的第一阶段可行性项目的基础上，拟议的第二阶段项目的具体目标是：（1）优化无线压力传感器和读出电子设备，以供体内流动使用。传感器的增强将通过建模、微加工和性能表征来实现和验证。(2)确定传感器材料的生物相容性。将使用具有统计学显著性的体内动物研究检查所有组成探头和包装材料的生物相容性。(3)证明准确的颅内压（ICP）测量和分流失败的检测。将使用体内犬模型对无线传感器与标准市售有线ICP探头进行急性和慢性测试。为了证明分流故障检测，将在体外设置和体内犬模型中检查无线传感器12个月。第二阶段项目的成功完成将为第三阶段的商业化提供一个明确的途径。最终的产品实施将为脑积水患者及其家人提供一种安全感，为他们提供一种可以快速检测当前分流故障并预测未来故障的流动系统。 公共卫生相关性： 每年在美国，有超过10，000名新生儿被诊断患有脑积水（“脑积水”），这是一种终身疾病，没有已知的治疗方法，幸运的是可以用分流器治疗，该分流器将脑中的液体重新引导到人体内的另一个位置。然而，由两个导管和一个压力调节阀组成的分流器容易发生故障，使脑积水患者面临持续永久性脑损伤的风险。拟议SBIR项目的最终目标是应用新技术开发一种可以监测分流功能的系统，从而改善患者结局并降低医疗成本。

DESCRIPTION (provided by applicant): Each year, there are over 10,000 newborns diagnosed with hydrocephalus in the United States. Hydrocephalus, an excessive accumulation of cerebrospinal fluid (CSF) within the head, is a lifelong disease with no known cure. Fortunately, hydrocephalus can be managed with CSF shunts which redirect excessive CSF elsewhere in the body. Unfortunately, 30-40% of shunts fail in the first year and blockages are the most common cause. Therefore, to reduce the risk of sustaining permanent brain damage or blindness, rapid diagnosis of shunt failure is critically important. The current protocol for detecting shunt failure is time-consuming and expensive since it relies on symptom diagnosis, brain scans, and percutaneous shunt tapping. Consequently, our ultimate objective is to develop an ambulatory system that can rapidly detect shunt failure without brain scans and invasive procedures, thereby improving patient outcomes and reducing healthcare costs. To accomplish this, shunts will be mounted with micro-miniature pressure sensors that are implantable, communicate outside the body wirelessly, and require no batteries. The sensors are strategically placed in the shunt using innovative packaging techniques, thus requiring no additional invasive surgical procedures for implantation. Wireless communications are performed through a low-power (microwatt) mutual inductive coupling between a handheld reader and the sensor. Building upon the successful Phase I feasibility project, the Specific Aims of the proposed Phase II project are to: (1) Optimize the wireless pressure sensor and readout electronics for in vivo ambulatory use. Sensor enhancements will be implemented and verified through modeling, microfabrication, and performance characterization. (2) Establish biocompatibility of sensor materials. All constituent sensor and packaging materials will be examined for biocompatibility using an in vivo, statistically significant animal study. (3) Demonstrate accurate intracranial pressure (ICP) measurements and detection of shunt failure. Wireless sensors will be acutely and chronically tested against standard, commercially-available, wired ICP probes using an in vivo canine model. For demonstration of shunt failure detection, wireless sensors will be examined in both an in vitro setup and an in vivo canine model for 12 months. Successful completion of the Phase II project would provide a clear pathway for Phase III commercialization. The ultimate product implementation will give hydrocephalus sufferers and their families a sense of security by providing them with an ambulatory system that can rapidly detect current shunt failures and predict future ones. PUBLIC HEALTH RELEVANCE: Each year in the U.S., there are over 10,000 newborns diagnosed with hydrocephalus ("water on the brain"), a lifelong disease with no known cure that can fortunately be treated with a shunt that redirects fluid in the brain to another location within the human body. The shunt, consisting of two catheters and a pressure regulated valve, however, are prone to malfunction, putting the hydrocephalic patient at risk of sustaining permanent brain injury. The ultimate goal of the proposed SBIR project is to apply novel technologies to develop a system which can monitor shunt functionality, resulting in better patient outcomes and lower healthcare costs.