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

开发用于治疗脑积水的具有 ICP 反馈的智能分流器

• 批准号: 10699566
• 负责人: TYLER WANKE
• 金额: $ 46.98万
• 依托单位: MADISON SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10699566
• 关键词: Achievement; Activities of Daily Living; Animal Model; Animals; Architecture; Area; Brain; Budgets; Catheters; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Cessation of life; Childhood; Communication; Coughing; Custom; Data; Development; Devices; Diagnostic; Disease; Distal; Drainage procedure; Effectiveness; Ensure; Epidemic; Exclusion; Failure; Feedback; Force of Gravity; Goals; Greater sac of peritoneum; Health Care Costs; Healthcare Systems; Hospitalization; Housing; Hydrocephalus; Implant; Incidence; Individual; Intracranial Hypertension; Intracranial Pressure; Liquid substance; Marketing; Measurement; Measures; Modality; Modeling; Monitor; Neurologic; Obstruction; Operative Surgical Procedures; Patients; Performance; Physiological; Polychlorinated Biphenyls; Positioning Attribute; Posture; Readiness; Recurrence; Repeat Surgery; Research; Risk; Sampling; Second Look Surgery; Secondary to; Shunt Device; Signal Transduction; Sneezing; Specific qualifier value; System; Technology; Testing; Therapeutic; Time; Translating; Ventricular; Work; absorption; body position; design; disabling symptom; implanted sensor; improved; in vivo; invention; neurosurgery; novel; operation; performance tests; porcine model; preclinical study; pressure; pressure sensor; prevent; primary endpoint; prototype; response; safety and feasibility; sensor; sensor technology; success; technology platform; transmission process; virtual; wireless communication

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.

项目概要 脑积水是一种破坏性的疾病，其特征是脑脊液 (CSF) 在大脑中积聚。 最常用的脑积水治疗方法是脑脊液分流术，其中导管将多余的脑脊液从脑脊液中转移出来。 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 尽管自首次引入分流器以来的 6 年来技术取得了进步， 近 40% 的分流术在放置后一年内失败，大多数在 3 年内失败，需要多次修复 这意味着患者会出现反复出现的虚弱症状，这是不必要的。 住院、手术和死亡，最终每年给医疗保健系统造成的损失远远超过 20 亿美元。 尽管当今市场上存在的许多分流器都试图控制重力和其他变量 经过研究，目前的分流系统都无法可靠地工作以防止分流故障。 “智能分流器”，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： 监测并排出每位患者的最佳脑脊液量，从而消除 排水不足/过度排水，最终降低分流阻塞和长期并发症的风险 该装置是由 ICP 传感器、通信组成的多系统技术。 传感器将大脑内的瞬时压力传输到微控制器。 将传入的压力转化为移动平均线，而平均线则排除了瞬态压力。 与位置（重力）或日常生活活动（咳嗽、用力等）相关的瞬时 ICP 变化 当平均 ICP 超过阈值时，微控制器会发送信号来打开阀门。 商业阀门，在任何 ICP 升高的情况下都会打开（例如，咳嗽或突然站立）， 我们的智能阀门将以受控方式打开，消除不稳定的排水。 我们的团队已经对分流系统的每个组件进行了原型设计并进行了概念验证。 一些组件需要更高一级的开发来提高技术的准备度，一些关键 子系统具有较高的技术风险，如果克服这些风险，将使整个系统的集成和成功 分流系统安全有效地运行，该设备的完成将标志着一流的“智能”。 有效监测 ICP 并适当引流脑脊液的分流器。