SBIR Phase II: Development of a novel graft to provide safe and reliable vascular access for hemodialysis patients

这项二期小企业创新研究（SBIR）项目的广泛/商业影响将推动一种设备的开发，以消除与维护性血液透析相关的并发症，这是一种用于肾衰竭患者的维持生命的治疗方法。血液透析（HD）使血液被抽出并通过透析机循环，透析机发挥衰竭肾脏的功能。这个过程必须定期重复，因此需要重复的高流量循环血液。由于访问方式和设备故障导致的不良事件频繁发生，每年给医疗保健系统造成数十亿美元的损失，并导致患者的严重发病率和死亡率。目前，市场上还没有解决透析移植物针头损伤或由于针头损伤而导致移植物材料降解的技术。该装置将最大限度地减少慢性HD患者的损伤水平，并降低严重并发症的可能性。拟议的二期SBIR项目将推进用于血液透析的假体动静脉移植物（AVGs）技术。一般原则是设计一个具有优化刚性的背板材料的移植物，以防止针损伤，同时保持足够的灵活性，以最大限度地提高最佳流量。技术目标包括：1)系统工程优化交易空间的性价比；2)高级生物相容性检测；3)设计验证和验证测试。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader/commercial impact of this Phase II Small Business Innovation Research (SBIR) project will advance the development of a device to eliminate complications associated with maintenance hemodialysis, a life-sustaining therapy for patients suffering from renal failure. Hemodialysis (HD) enables blood to be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys. This process must be repeated at regular intervals and thus requires repeated, high flow access to circulating blood. Adverse events due to mode of access and device failure are frequent, costing the healthcare system billions of dollars per year and leading to significant morbidity and mortality for patients. Currently, no technology on the market addresses dialysis graft needle injury or graft material degradation due to needle trauma. The proposed device will minimize injury levels and decrease the probability of serious complications for chronic HD patients.The proposed Phase II SBIR project will advance a technology for prosthetic arteriovenous grafts (AVGs) for hemodialysis. The general principle is to engineer a graft with a backplate material optimized for rigidity to prevent needle injury, while maintaining sufficient flexibility to maximize optimal flow. The technical objectives include: 1) systems engineering to optimize the cost and performance trade space; 2) advanced biocompatibility testing; 3) design verification and validation testing.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.