Cerebral Spinal Fluid Shunt System with Dual Lumen Distal Catheter Redundancy to Minimize Revision Surgery

摘要 意义：脑脊液(CSF)分流失败导致翻修手术是 脑积水患者。高达50%的分流术在植入后两年内失败。美国国立卫生研究院资助的一个专家小组 将改进的分流设计确定为改善脑积水患者预后的研究重点。遮挡 是最常见的脑脊液分流失败模式，分流失败率超过几次后变化不大 几十年的使用。创新：建议的产品是双腔远端导管，提供模块化 冗余，这是通过复制关键组件来提高可靠性的众所周知的原则。这根导管 设计在主通道闭塞时自动改变通过原始备用通道的流量， 消除了手术分流修正的需要。这项技术创新具有低成本、低风险、易推广的特点 实施与当前CSF分流协议兼容的新型分流设计。假设：网络中的冗余 远端导尿管流道可延长脑脊液分流术的使用寿命。更长的分流术寿命将减少患者 通过预防过高的颅内压和最大限度地减少昂贵的翻修手术来降低发病率 做手术。初步数据：申请者已经进行了台式实验，证明了 双腔远端导管。SBIR第一阶段项目目标：开发一种脑脊液分流装置，将 需要做翻修手术。目的1：设计冷冻双腔远端导管进行可行性试验。远端 导管设计将根据(A)目标1专家设计输入和 CSF分流供应商输入(B)试验台和体外设计研究。里程碑：远端双腔的设计研究 导管原型将展示满足功能要求的潜力。目标2：双腔 远端导管可行性测试。目标是生成证明SBIR可行性的测试数据 第二阶段进一步研究，重点是为FDA提交的远端导管设计验证测试 和临床研究。目标1远端导管连接到目前市场上销售的FDA批准的脑脊液分流阀 近端导管组件将以描述性分析的结果进行评估。这个测试 在测试之前，设备将经过灭菌和老化。目标1将首先评估远端导管的设计 试验台和体外试验(每个GLP试验10根导管)以及随后的体内试验(每个类GLP试验n=16根导管 实验)用四只实验动物。该可行性测试将包括普遍接受的功能 ISO 7197中概述的要求以及改道机构性能的台架和体外测试。 里程碑：双腔远端导管将通过功能测试成功证明其可行性 标准。 。

Abstract Significance: Cerebral spinal fluid (CSF) shunt failure resulting in revision surgery is a major problem for hydrocephalus patients. Up to 50% of shunts fail within two years of implant. A NIH funded expert panel has identified improved shunt design as a research priority to improve hydrocephalic patient outcomes. Occlusion is the most common CSF shunt failure mode, and little has changed with shunt failure rates over several decades of use. Innovation: The proposed product is a dual lumen distal catheter providing modular redundancy, a well-known principle for increasing reliability by duplicating critical components. This catheter design automatically reroutes flow through a pristine back-up channel upon occlusion of the primary channel, eliminating the need for surgical shunt revision. This technological innovation is low cost, low risk, and easy to implement novel shunt design compatible with current CSF shunt protocols. Hypothesis: Redundancy of the distal catheter flow channel can extend the working life of CSF shunts. Longer shunt life will reduce patient morbidity by preventing excessive intracranial pressures and by minimizing the need for costly revision surgery. Preliminary Data: Applicant has performed bench experiments demonstrating proof of concept for the dual lumen distal catheter. SBIR Phase I Project Objective: Develop a CSF shunt that minimizes the need for revision surgery. Aim 1: Freeze dual lumen distal catheter design for feasibility testing. Distal catheter design will be finalized to meet human use requirements based on (a) Aim 1 expert design input and CSF shunt supplier input (b) bench and in vitro design studies. Milestone: Design studies of dual lumen distal catheter prototypes will demonstrate the potential for meeting functional requirements. Aim 2: Dual lumen distal catheter feasibility testing. The objective is to generate test data demonstrating feasibility for SBIR Phase II further research, which will focus on distal catheter design verification testing for FDA submissions and clinical studies. Aim 1 distal catheters connected to currently marketed and FDA cleared CSF shunt valve and proximal catheter components will be assessed with results reported as descriptive analysis. The test devices will be sterilized and aged prior to testing. Aim 1 distal catheter design will be evaluated first with bench and in vitro tests (n=10 catheters per GLP test) and subsequently in vivo (n=16 catheters per GLP-like experiment) with four test animals. This feasibility testing will include commonly accepted functional requirements outlined in ISO 7197 as well as bench and in vitro testing of rerouting mechanism performance. Milestone: The dual lumen distal catheters will demonstrate feasibility by meeting functional test success criteria. .