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

 描述(申请人提供)：在美国，60多万名终末期肾病(ESRD)患者平均每周进行超过1,800,000次血液透析。对这些患者中的任何一个来说，一个严重的危险是静脉针头移位(VND)，这是一种灾难性的、可能致命的意外移除将血液泵回体内的针头。发病率估计差异很大，但在任何一周，都可能有200多名血液透析患者发生VND。仅在美国，每年进行的约1亿次血液透析中，VND就是一个持续且无处不在的危险。整个行业迫切需要一种廉价、实用和广泛适用的解决方案，可以轻松地确保患者在血液透析期间的安全。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产品，将保护血液透析患者在发生VND时避免致命出血。V-Needle将是一种低成本、易于制造和易于操作的系统，将保护患者免受VND的破坏性影响。在第一阶段的SBIR研究中，我们总结地展示了概述制造这种设备的可行性的工程特征。在这个第二阶段项目中，我们现在优化设计并准备设备以提交给FDA以供美国市场批准：特定-目标#1：与FDA会面以敲定监管策略并开始文档编制：1.1)准备会前报告并与FDA制定战略以征求监管计划1.2)开始FDA强制要求的用户需求、设计输入/输出文件用于设计历史文件1.3)实施并记录风险管理策略特定的-目标#2：制定优化的、V-针的阿尔法设计：2.1)通过减少所需的注塑部件的数量来降低设计的复杂性2)实施具有将简化初始插入的“武装”机制的V-针2)使设计小型化，使得新产品在当前针身尺寸的25%以内-目标3：表征和评估阿尔法-V-针，迭代到β：3.1)确定最终的V-针部件材料并建立生物兼容性3.2)量化闭合力，使用定制台式流动装置的背压和流动3.3)建立人为因素和其他工程标准，以便优化的V-针满足预期的用户需求(通过临床工作人员/患者访谈)3.4)证明α-V-针防止动物(狗)移位-目标#4确定β-V-针的安全性和有效性，转化为生产前：4.1)通过训练假人的模拟使用测试评估临床实施4.2)证明Beta V-Needle可防止动物(狗)移位-目标#5准备并向FDA提交最终的510(K)申请：5.1)与FDA顾问Experien Group合作准备/提交510(K)申请国际专利正在申请国际专利的V-Needle具有拯救生命、改善患者护理的潜力，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将优化我们的工作原型，使其成为强大的、商业上可行的产品。第二阶段的研发工作将集中在产品验证和确认上，包括生物兼容性测试、功能测试、动物测试和模拟 使用测试。此外，将执行FDA要求的所有相关文件，以使FDA能够进行有效的审查。在第二阶段结束时，Hemotek将有一个完整的工作和验证版本的V-Needle准备好提交给FDA。试制样机的再现。

 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.