SBIR Phase II: Application of a Durable Self-sealing Material for Hemodialysis Blood Access

该小型企业创新研究（SBIR）第二阶段项目的重点是开发一种新型自密封材料技术，主要应用于为血液透析患者设计耐用的血液通路系统。 仅在美国就有近580，000人患有终末期肾病（ESRD），并且超过400，000人使用血液透析作为主要治疗模式进行治疗。 目前的通路系统既不是为重复通路设计的，也不是为血液透析治疗后的出血管理设计的，因此通常会导致继发性并发症。 该提案的研究目的是：1）开发器械生产的制造方法，2）确定材料技术的生物相容性，3）开发动物模型以评价潜在的临床影响，该项目的更广泛的影响/商业潜力，如果成功，将产生一种独特的新型材料，将创造从治疗血液透析并发症到预防并发症的范式转变。 这将满足临床市场需求，并改变报销政策，以创造更好的临床结果并控制成本。 目前，270亿美元用于为终末期肾病患者提供血液透析治疗。 正在开发的材料技术将使血管通路设备适用于几乎所有的血液透析患者群体，从而创造一个估计超过5亿美元的可寻址市场规模。 这项研究将通过引入新的工程和制造方法来提高科学认识，这些方法适用于血液透析以外的广泛应用，这些应用需要重复进入和可靠密封。

This Small Business Innovation Research (SBIR) Phase II project focuses on the development of a novel self-sealing materials technology for the primary application of designing durable blood access systems for hemodialysis patients. Nearly 580,000 people in the United States alone have end stage renal disease (ESRD), and over 400,000 people are treated using hemodialysis as the primary mode of treatment. Current access systems are neither designed for repeated access nor managing bleeding after hemodialysis treatment, and as a result commonly lead to secondary complications. The research aims of the proposal are to: 1) Develop manufacturing methods for device production, 2) Determine biocompatibility of the materials technology, and 3) Develop an animal model to evaluate potential clinical impact.The broader impact/commercial potential of this project, if successful, will yield a unique and novel material that will create a paradigm shift from the treatment of complications due to hemodialysis to prevention. This will address clinical market needs and shift reimbursement policies to create better clinical outcomes and contain costs. Currently, $27 billion is spent on the delivery of hemodialysis treatment for ESRD patients. The materials technology under development will lead to vascular access devices suitable for nearly the entire hemodialysis patient population, thereby creating an estimated addressable market size of more than $500 million. This research will enhance scientific understanding by introducing novel engineering and manufacturing methods for a broad range of applications beyond hemodialysis where repeated access and reliable sealing is required.