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。它将作为现有血液透析针头的替代品。V-Needle将使用巧妙设计的故障安全机械技术在VND期间检测和限制错误的血流。该I期SBIR研究的可行性评估需要以下三个具体目标：具体目标#1，限流设计：在该目标中，我们设计并证明了优化的内部针头限流机制，该机制将持续产生足够高的管路背压，以在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感测技术，该技术可用于识别VND的可能发生并启动目标#1的校正流量限制机制。 具体目标#3：工作原型制造商：最后，我们将皮肤传感和流量限制技术集成到一个工作的V型针原型和验证性能的模拟循环设置使用猪皮。 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实验室测试的原型设计，显示产品的可行性。在第二阶段，Hemotek将把原型优化成一个强大的、大批量生产的、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，以实现高效的FDA审查。在第II阶段结束时，Hemotek将拥有一个完整的工作和确认版本的V型针，可用于向FDA提交510（k）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.