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600,000名终末期肾病（ESRD）患者进行超过180万次血液透析。静脉针头脱位（VND）对这些患者来说是一个严重的危险，这是一种灾难性的、潜在致命的意外移除针头，将血液泵回体内。发生率估计差异很大，但在任何给定的一周内，可能有200多名血液透析患者会发生VND。VND是一种持续存在的危险，每年仅在美国进行的约1亿次血液透析中，它就笼罩着每一个人。整个行业迫切需要一种廉价、实用和广泛适用的解决方案，可以轻松确保患者在血液透析期间的安全。为了满足这一需求，haemtek发明了V-Needle，这是一种一次性失效安全的透析安全产品，可以保护血液透析患者在发生VND时免于致命的大出血。V-Needle将是一种低成本、易于制造、操作简单的系统，将保护患者免受VND的破坏性影响。它将成为现有血液透析针头的替代品。V-Needle将在VND期间使用巧妙设计的故障安全机械技术检测和限制错误的血流。第一阶段SBIR研究的可行性评估需要以下三个具体目标：具体目标#1，流量限制设计：在这个目标中，我们设计并演示了一种优化的内部针头流量限制机制，该机制将持续产生足够高的管道回压，从而在VND期间触发血液透析机关闭。具体目标2，VND检测设计：在这里，我们开发了一种基于弹簧加载针的皮肤传感技术，可用于识别可能发生的VND，并启动Aim #1的纠正流量限制机制。具体目标#3：工作原型制造：最后，我们将皮肤传感和流量限制技术集成到工作v针原型中，并使用猪皮在模拟循环设置上验证性能。正在申请专利的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。第一阶段将产生一个经过测试的原型设计，展示产品的可行性。在第二阶段，hemtek将优化原型，使其成为强大的、大批量生产的、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，包括生物相容性测试、功能测试和模拟使用测试。此外，将开发一个强大的医疗器械设计历史文件，以实现有效的FDA审查。在II期结束时，hemtek将有一个完整的工作和验证版本的V-Needle准备510(k)提交给FDA和随后的大规模生产。

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. It will be offered a a stand-in replacement to existing hemodialysis needles. The V-Needle will detect and restrict errant blood flow during VND using cleverly designed failsafe mechanical technology. Feasibility assessment of this Phase I SBIR study requires the following three specific aims: Specific-aim #1, Flow Restriction Design: In this aim we design and demonstrate an optimized internal needle flow restriction mechanism that will consistently generate tubing back pressures high enough to trigger hemodialysis machine shut-off during VND. Specific Aim #2, VND detection Design: Here we develop a spring-loaded needle-based skin sensing technology that can be used to both identify the likely occurrence of VND and initiate the corrective flow restriction mechanism of Aim #1. Specific Aim #3: Working prototype Manufacture: Finally, we integrate both skin-sensing and flow restriction technologies into a working V-Needle prototype and validate performance on a mock circulatory set-up using porcine skin. The 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. Phase I will result in a bench-tested prototype design showing product feasibility. In Phase II, Hemotek will optimize the prototype into a robust, high-volume manufactured, commercially viable product. Phase II R&D efforts will center on product verification and validation, including biocompatibility testing, functionality testing, nd simulated use testing. In addition a robust Medical Device Design History file will be developed 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 and subsequent mass manufacture.