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

SBIR 二期：耐用自密封材料在血液透析血液通路中的应用

• 批准号: 1329172
• 负责人: James Hong
• 金额: $ 50万
• 依托单位: Solinas Medical, Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-01 至 2018-02-28
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1329172&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Application; Durable

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.

这个小型企业创新研究(SBIR)第二阶段项目专注于开发一种新型的自密封材料技术，用于设计血液透析患者的耐用血液访问系统的主要应用。仅在美国就有近58万人患有终末期肾病(ESRD)，超过40万人使用血液透析作为主要治疗模式。目前的通路系统既不是为重复通路而设计的，也不是为血液透析治疗后的出血管理而设计的，因此通常导致继发性并发症。该提案的研究目标是：1)开发设备生产的制造方法，2)确定材料技术的生物相容性，3)开发动物模型来评估潜在的临床影响。如果该项目成功，将产生一种独特的新材料，将创造从治疗血液透析并发症到预防的范式转变。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，为终末期肾病患者提供血液透析治疗的费用为270亿美元。正在开发的材料技术将带来适用于几乎所有血液透析患者群体的血管接入设备，从而创造出估计超过5亿美元的潜在市场规模。这项研究将通过为血液透析以外的广泛应用引入新的工程和制造方法来加强科学理解，在这些应用中，需要反复接触和可靠的密封。