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

这个SBIR一期项目将推进一种新型动静脉移植物的开发，这种移植物将最大限度地减少慢性血液透析患者的损伤和减少严重并发症的可能性。血液透析是肾衰竭患者的一种维持生命的治疗方法；它需要血液被抽出，并通过透析机循环，以发挥衰竭肾脏的功能。这个过程必须定期进行，并且需要用大孔针头进入血液。移植失败并发症，许多直接归因于针头损伤，每年花费医疗保健系统数十亿美元，并导致患者显著发病率甚至死亡率。全世界有近250万肾衰竭患者接受透析，这一人口正以每年8%的速度增长。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。InnAVasc Medical的新型移植物设计有可能减少与移植物压迫和无意穿刺相关的并发症，从而减少不良事件，显着改善患者的预后和生活质量，同时显着降低与慢性透析移植物损伤相关的医疗保健费用。该项目将大大推进一种创新设备的开发，该设备将同时允许在移植物植入后立即插管（典型的是在插管前允许4周愈合），并消除维护性血液透析期间重复插管相关的并发症。本提案的最终目标是确定和设计一种合适的生物相容性材料，该材料将提供所需的机械强度，以承受透析针进入不希望的区域，同时具有足够的灵活性，以允许最佳的血液流经设备，并为各种形状，大小和皮肤完整性的患者提供足够的一致性。第一个技术目标将集中于确定候选材料并测试其强度、柔韧性和耐久性。第二个目标将采用有前途的候选材料并开发原型设备以评估可制造性和性能。这些目标将确定一种合适的材料，使InnAVasc移植物能够面向最广泛的患者群体销售。该项目的成功完成将提供一个原型装置，该装置将同时优化所需的机械强度与柔韧性的比例。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。

This SBIR Phase I project will advance the development of a novel arteriovenous graft that will minimize injury and decrease the probability of serious complications for chronic hemodialysis patients. Hemodialysis is a life-sustaining therapy for patients suffering from kidney failure; it requires that blood be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys. This process must be performed at regular intervals and requires access to the blood with large bore needles. Graft failure complications, many directly attributable to needle injury, cost the healthcare system billions of dollars per year and lead to significant morbidity and even mortality for patients. There are nearly 2.5 million patients with kidney failure who receive dialysis worldwide, and this population is growing at a rate of 8% per year. Currently, no technology on the market addresses dialysis graft needle injury or graft material degradation due to needle trauma. InnAVasc Medical's novel graft design has the potential to reduce complications associated with aggressive graft compression and inadvertent punctures, thus reducing adverse events and dramatically improving patient outcomes and quality of life while significantly reducing health care costs related to chronic dialysis graft injury. This project will substantially advance the development of an innovative device that will simultaneously allow for immediate cannulation following graft implantation (typical is to allow 4 weeks to heal prior to cannulation) and eliminate complications associated with repeated cannulation during maintenance hemodialysis. The ultimate goal of this proposal is to identify and engineer a suitable biocompatible material that will provide the desired mechanical strength to withstand passage of the dialysis needle into undesirable areas, while being sufficiently flexible to allow for optimal blood flow through the device and adequate conformity for patients of all shapes, sizes, and skin integrity. The first technical objective will focus on identifying candidate materials and testing their strength, flexibility and durability. The second objective will take promising candidate materials and develop prototype devices to assess manufacturability and performance. These aims will identify a suitable material that will enable the InnAVasc graft to be marketable to the broadest patient population. Successful completion of this project will provide a prototype device constructed of materials that will simultaneously optimize the desired ratio of mechanical strength to flexibility.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.