SBIR Phase I: Application of a Self-sealing Composite Structural Material for Hemodialysis Blood Access

该小型企业创新研究（SBIR）第一阶段项目旨在开发一种新型自密封材料，用于设计血液透析患者的耐用血液通路系统。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）开发自密封止血材料，2）创建适合血管通路应用的设计，以及3）评估慢性动物模型中设计的安全性和有效性。该研究将利用跨学科领域的知识来完成该提案的目标，并证明相对于商业等同技术的增强性能。该项目的更广泛影响/商业潜力将产生一种独特的新型材料，将创造从治疗并发症到预防的范式转变，以创造更好的临床结局并控制成本。 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。 这种材料技术将导致适用于整个血液透析患者群体的血管通路装置，从而创造超过4亿美元的估计市场规模。该材料技术平台可应用于血液透析以外的广泛应用，其中需要重复进入和可靠密封。

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a novel self-sealing material to be applied to the design of durable blood access systems for hemodialysis patients. 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 a self-sealing hemostatic material, 2) Create designs suitable for vascular access applications, and 3) Assess safety and efficacy of the designs in a chronic animal model. The research will draw upon knowledge in cross-disciplinary fields to complete the aims of the proposal, and demonstrate enhanced performance relative to commercial predicate technology.The broader impact/commercial potential of this project will yield a unique and novel material that will create a paradigm shift from the treatment of complications to prevention to create better clinical outcomes and contain costs. 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. This materials technology will lead to vascular access devices suitable for the entire hemodialysis patient population, thereby creating an estimated market size of more than $400 million. And this materials technology platform may be applied to a broad range of applications beyond hemodialysis where repeated access and reliable sealing is required.