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

该SBIR I期项目将推进新型动静脉移植物的开发，该移植物将最大限度地减少慢性血液透析患者的损伤并降低严重并发症的可能性。血液透析是肾衰竭患者的生命维持疗法;它需要抽取血液并通过执行衰竭肾脏功能的透析机循环。这个过程必须定期进行，并且需要用大口径针头进入血液。移植失败并发症，许多直接归因于针损伤，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甚至死亡率。全世界有近250万肾衰竭患者接受透析治疗，这一人群正以每年8%的速度增长。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。InnAVasc Medical的新型移植物设计有可能减少与积极的移植物压缩和意外穿刺相关的并发症，从而减少不良事件并显著改善患者的结局和生活质量，同时显著降低与慢性透析移植物损伤相关的医疗保健成本。该项目将大大推进创新器械的开发，该器械将同时允许移植物植入后立即插管（通常在插管前允许4周愈合），并消除维持性血液透析期间与重复插管相关的并发症。本提案的最终目标是确定和设计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期望的区域，同时具有足够的柔性以允许最佳血液流过器械，并对所有形状、尺寸和皮肤完整性的患者具有足够的贴合性。第一个技术目标将侧重于确定候选材料，并测试其强度、灵活性和耐用性。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覆膜支架能够销售给最广泛的患者人群。该项目的成功完成将提供一个原型装置，该装置由同时优化机械强度与柔性的理想比例的材料制成。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。

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 Hemodialysis is a life-sustaining therapy for patients suffering from kidney failure; it requires that blood be withdrawn and cycled through a dialysis machine that performs the function of the failed kidneys.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.