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

这一小型企业创新研究（SBIR）项目的II期更广泛/商业影响将推动器械的开发，以消除与维持性血液透析相关的并发症，维持性血液透析是肾衰竭患者的生命维持疗法。 血液透析（HD）使血液能够通过执行衰竭肾脏功能的透析机抽取和循环。这个过程必须以规律的间隔重复，因此需要重复的高流量进入循环血液。由于进入模式和设备故障导致的不良事件频繁发生，每年花费医疗保健系统数十亿美元，并导致患者的显著发病率和死亡率。目前，市场上没有技术解决透析移植物针损伤或由于针创伤导致的移植物材料降解。 拟议的设备将最大限度地减少损伤水平，降低慢性血液透析患者发生严重并发症的可能性。拟议的第二阶段SBIR项目将推进血液透析用人工动静脉移植物（AVG）的技术。 一般原则是设计一种具有背板材料的移植物，该背板材料针对刚性进行了优化以防止针损伤，同时保持足够的柔性以最大化最佳流量。 技术目标包括：1）优化成本和性能交易空间的系统工程; 2）先进的生物相容性测试; 3）设计验证和确认测试。该奖项反映了NSF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 Hemodialysis (HD) enables blood to be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys.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.