The V-Needle: A Failsafe Protection against Needle Dislodgement during Dialysis

 描述（由申请人提供）：在美国，平均每周有超过60万名终末期肾病（ESRD）患者进行超过1，800，000次血液透析。对这些患者来说，一个严重的危险是静脉针移位（VND），这是一种灾难性的和潜在的致命的意外移除针头，将血液泵回体内。发病率估计差异很大，但在任何一周内，可能有超过200名血液透析患者发生VND。VND是一种持续存在的危险，仅在美国每年进行的约100，000，000次血液透析中的每一次都存在这种危险。整个行业都迫切需要一种廉价、实用和广泛适用的解决方案，可以轻松确保血液透析期间的患者安全。 为了满足这一需求，Hemotek发明了V-Needle，这是一种一次性故障安全透析安全产品，可保护血液透析患者在VND发生期间免于致命出血。V-Needle将是一种低成本，易于制造和操作简单的系统，将保护患者免受VND的破坏性影响。在I期SBIR研究中，我们最终展示了概述制造此类器械可行性的工程表征。在该II期项目中，我们现在优化设计并准备提交给FDA批准在美国上市的器械：具体目标#1：与FDA会面以最终确定监管策略并开始文档编制：1.1）准备会前报告，并与FDA一起制定策略，以征求监管计划1.2）开始FDA规定的用户需求，设计历史文件的设计输入/输出文件1.3）执行并记录风险管理策略具体目标#2：为V型针开发优化的alpha设计：2.1）通过减少所需的可模制部件的数量来降低设计复杂性简化初始插入的"启动"机制2.3）设计小型化，使新产品在当前针体尺寸的25%范围内。具体目标#3：表征和评估α V型针，从β型到β型：3.1）确定最终V形针组件材料并确定生物相容性3.2）量化闭合力，3.3）建立人为因素和其他工程标准，以便优化的V-缝针符合预期用户需求（通过临床工作人员/患者访谈）3.4）证明alpha V针可防止动物（犬）移位具体目标#4确定beta V针的安全性和有效性，转化为预生产：4.1）通过对训练假人进行模拟使用测试评估临床实施4.2）证明beta V型针可防止动物（犬）移位具体目标#5准备并提交最终510（K）向FDA申请：5.1）与FDA顾问Experien Group合作，准备/提交510（K）正在申请国际专利的V-Needle有可能挽救生命，改善患者护理，并为血液透析患者和护理提供者提供无价的安心。在第二阶段，Hemotek将把我们的工作原型优化为一个强大的、商业上可行的产品。第二阶段研发工作将集中在产品验证和确认上，包括生物相容性测试、功能性测试、动物测试和模拟 使用测试。此外，还将执行FDA要求的所有相关文件，以便进行有效的FDA审查。在第II阶段结束时，Hemotek将准备好V型针的完整工作和经确认版本，以便向FDA提交510（k）。一个预生产原型的再现。

 DESCRIPTION (provided by applicant): On average, more than 1,800,000 sessions of hemodialysis are performed each week in the U.S. by more than 600,000 end stage renal disease (ESRD) patients. A grave danger to any of these patients is Venous Needle Dislodgement (VND), a catastrophic and potentially deadly unintended removal of the needle pumping blood back into the body. Incident rate estimates vary widely, but in any given week, possibly more than 200 hemodialysis patients will suffer an incidence of VND. VND is a constant and ever-present danger that looms over each and every one of the ~100,000,000 hemodialysis sessions performed each year in the US alone. The entire industry is in dire need of an inexpensive, practical and widely applicable solution that can easily insure patient safety during hemodialysis. To fill this need, Hemotek has invented the V-Needle, a disposable failsafe dialysis safety product that will protect hemodialysis patients from deadly bleed-out during incidences of VND. The V-Needle will be a low-cost, easy-to-manufacture, and simple-to-operate system that will protect patients from the devastating effects of VND. In a Phase I SBIR study we conclusively showed the engineering characterizations that outlined the feasibility of manufacturing such a device. In this Phase II project, we now optimize that design and prepare the device for submission to the FDA for approval to market in the US: Specific-aim #1: Meet with the FDA to finalize a regulatory strategy and Begin documentation: 1.1) Prepare a pre-meeting report and Strategize with the FDA to solicit a regulatory plan 1.2) Begin FDA-mandated User Needs, Design Inputs/Output files for the Design History File 1.3) Conduct and document a Risk Management Strategy Specific-aim #2: Develop an optimized, alpha design for the V-Needle: 2.1) Decrease design complexity by reducing the number of moldable components required 2.2) Implement the V-Needle with an `arming' mechanism that will simplify initial insertion 2.3) Miniaturize the design so that the new product is within 25% of current needle-body sizes Specific-aim #3: Characterize and Assess the alpha V-Needle, iterate to beta: 3.1) Determine final V-Needle component materials and Establish biocompatibility 3.2) Quantify closing force, backpressure and flow using a custom benchtop flow apparatus 3.3) Establish human factors and other engineering criteria so the optimized V-Needle meets intended user needs (via clinical staff/patient interviews) 3.4) Demonstrate that the alpha V-Needle protects against dislodgement in animals (dog) Specific-aim #4 Determine beta V-Needle safety and efficacy, translate to pre-production: 4.1) Assess clinical implementation via simulated use testing on training dummies 4.2) Demonstrate that the beta V-Needle protects against dislodgement in animals (dog) Specific-aim #5 Prepare and Submit a finalized 510(K) application to the FDA: 5.1) Collaborate with FDA consultants, The Experien Group, to prepare/submit a 510(K) The internationally patent-pending V-Needle has the potential to save lives, improve patient care and provide priceless peace of mind for hemodialysis patients and care providers. In Phase II, Hemotek will optimize our working prototype into a robust, commercially viable product. Phase II R&D efforts will center on product verification and validation, including biocompatibility testing, functionality testing, animal testing and simulated use testing. In addition all relevant FDA-required documentation will be performed to enable an efficient FDA review. At the end of Phase II Hemotek will have a full working and validated version of the V-Needle ready for 510(k) submission to the FDA. Rendition of a pre-production prototype.