Development of a Smart Shunt with ICP-feedback for the Treatment of Hydrocephalus

项目摘要 脑积水是一种破坏性的疾病，其特征是脑脊髓液（CSF）在大脑中积聚。 脑积水最常用的治疗方法是CSF分流术，其中导管将多余的CSF从脑积水中转移出来。 脑室通过单向阀到达身体中可以重新吸收液体的区域（最常见的是 腹膜腔）。尽管自分流器首次引入以来的60年里技术取得了进步， 近40%的分流器在放置一年内失效，大多数在3年内失效，需要多次翻修 每名患者的手术量。这转化为患者反复出现的衰弱症状， 住院和手术，以及死亡，最终每年花费医疗保健系统超过20亿美元。 虽然目前市场上存在的许多分流器都试图控制重力和其他变量， 研究表明，没有一个分流系统工作可靠，足以防止分流故障。我们正在开发 “智能分流”，一种综合诊断和治疗分流系统，旨在通过以下方式维持最佳ICP： 监测和引流每个给定患者的最佳CSF量，从而消除 引流不足/过度引流，最终降低分流阻塞和长期并发症的风险 与不稳定的排水有关该设备是一个多系统技术组成的ICP传感器，通信 模块和阀。传感器将大脑内部的瞬时压力传输到微控制器， 将传入的压力转换为移动平均线。移动平均线，反过来，排除了瞬态 与体位（重力）或日常生活活动（咳嗽、用力等）相关的瞬时ICP变化当 当平均ICP超过阈值时，微控制器发送信号以打开阀。而不是 商业阀门，其在任何ICP升高的情况下打开（例如，从咳嗽或突然站立）， 我们的智能阀门会以可控的方式打开，消除不稳定的排水。 我们的团队已经制作了分流系统每个组件的原型并进行了概念验证。而 一些组件需要更高一级的开发，以提高技术的成熟度，一些关键组件需要更高一级的开发， 子系统具有较高的技术风险，如果能够克服这些风险， 分流系统安全有效运行。该设备的完成将标志着一流的“智能” 有效监测ICP并适当引流CSF的分流器。

PROJECT SUMMARY Hydrocephalus is a devastating condition characterized by a buildup of cerebrospinal fluid (CSF) in the brain. The most utilized treatment for hydrocephalus is the CSF shunt in which a catheter diverts excess CSF from the ventricles of the brain through a one-way valve to an area in the body that can reabsorb the fluid (most commonly the peritoneal cavity). Despite technological advances in the 6 decades since the shunt was first introduced, nearly 40% of all shunts fail within one year of placement, and most fail within 3 years, requiring multiple revision surgeries per patient. This translates to recurring debilitating symptoms for the patient, unnecessary hospitalizations and surgery, and death, ultimately costing the healthcare system well over $2 billion annually. Although many shunts that exist on the market today have attempted to control for gravity and other variables researched, none of the current shunt systems works reliably enough to prevent shunt failure. We are developing a “smart shunt”, a comprehensive diagnostic and therapeutic shunt system that aims to maintain optimal ICP by monitoring and draining optimal amounts of CSF for each given patient, thus eliminating underdrainage/overdrainage, to eventually decrease the risk of shunt obstruction and long-term complications related to erratic drainage. The device is a multi-system technology composed of an ICP sensor, communication modules, and a valve. The sensor transmits instantaneous pressures inside the brain to a microcontroller, which transforms incoming pressures into a moving average. The moving average, in turn, excludes transient instantaneous ICP changes related to position (gravity) or activities of daily living (coughing, straining, etc.) When the average ICP exceeds a threshold, the microcontroller sends a signal to open the valve. As opposed to commercial valves, which open during any instance of elevated ICP (e.g., from a cough or sudden standing), our smart valve would open in a controlled fashion, eliminating erratic drainage. Our team has prototyped and shown proof-of-concept of each individual component of the shunt system. While some components need one more level of development to advance the readiness of the technology, a few key subsystems hold higher technical risk, which if overcome, would enable the integration and success of the overall shunt system to function safely and effectively. The completion of this device would mark the first-in-class “smart” shunt that effectively monitors ICP and appropriately drains CSF.