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.

项目摘要 脑积水是一种毁灭性的疾病，其特征是大脑中的脑脊液（CSF）积聚。 用于脑积水最常使用的治疗方法是CSF分流器，其中导管超过CSF从 大脑的心室通过单向阀到体内可以重新吸收液体的区域（最常见的是 腹膜腔）。尽管首次引入分流器以来的6年技术进步，但 将近40％的分流器在安置后一年失败，大多数在3年内失败，需要多次修订 每个患者的手术。这转化为患者的重复使人衰弱的符号，不必要 住院和手术以及死亡，最终使医疗体系耗资超过20亿美元。 尽管当今市场上存在的许多分流都试图控制重力和其他变量 经过研究，当前的分流系统都没有足够可靠的工作来防止分流故障。我们正在发展 “智能分流”是一种全面的诊断和治疗分流系统，旨在维持最佳ICP 为每个给定患者监测和排水最佳的CSF，从而消除 弱限制/超频，以最终降低分流目标和长期并发症的风险 与排水不稳定有关。该设备是由ICP传感器组成的多系统技术 模块和阀门。传感器将大脑内部的瞬时压力传递到微控制器，该电路机 将传入的压力转变为移动平均线。移动平均线反过来不包括瞬态 瞬时ICP变化与位置（重力）或日常生活活动（咳嗽，紧张等）有关 平均ICP超过阈值，微控制器发送信号以打开阀门。而不是 商业阀，在ICP升高的任何情况下开放（例如，咳嗽或突然站立）， 我们的智能阀将以受控的方式打开，消除排水不稳定。 我们的团队对分流系统的每个组件进行了原型概念概念证明。尽管 有些组件需要再开发一级才能提高技术的准备，这是一些关键 子系统拥有更高的技术风险，如果克服了，则可以使整体的整合和成功 分流系统可以安全有效地运行。该设备的完成将标志着第一类“ Smart” 分流有效地监视ICP并适当排除CSF。