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。它将被提供一个替代现有血液透析针的替代品。V-Needle将检测和限制VND期间的错误血流，使用巧妙设计的故障保护机械技术。这项第一阶段SBIR研究的可行性评估需要以下三个具体目标：特定目标#1，限流设计：在这个目标中，我们设计并演示了一种优化的内部针流限流机构，该机构将持续产生足够高的管道背压，足以在VND期间触发血液透析机的关闭。具体目标#2，VND检测设计：在这里，我们开发了一种基于弹簧的针式皮肤传感技术，可以用于识别可能发生的VND，并启动Aim#1的纠正血流限制机制。具体目标#3：工作原型制造：最后，我们将皮肤传感和血流限制技术集成到工作V-Needle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。第一阶段将进行台架测试的原型设计，以显示产品的可行性。在第二阶段，Hemotek将把原型优化为强大的、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，包括生物兼容性测试、功能测试和模拟使用测试。此外，将开发一个健壮的医疗器械设计历史文件，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.