SBIR Phase I: A Novel Valved Hemodialysis Catheter

这个小型企业创新研究第一阶段项目将开发一种新型血液透析导管，该导管带有一个集成的远端阀门，可以从近端枢纽打开和关闭。慢性血液透析导管的使用与感染、血栓形成和闭锁溶液丢失等严重并发症有关。这种新的设备将是第一个为临床医生提供管理这些并发症的工具。研究目标包括改进远端瓣膜的设计；改进近端轮毂的设计；以及对锁液丢失和导管血栓的体外评估。该项目将创建和评估至少三个远端阀门设计概念，其中最有希望的原型将在性能和可制造性方面进行优化。近端轮毂设计将进行类似的评估和优化。最终的远端阀门和近端轮毂设计也将经过验证和验证，以确保它们满足产品性能要求。已发表的体外模型将被用来研究最终的装置-S防止锁定液丢失的能力及其导致导管血栓的趋势。与标准导管相比，这一新型设备有望带来更好的结果。该项目的更广泛影响/商业潜力是一种颠覆性的新型血液透析导管，用于血管接入设备市场，2009年美国市场价值超过30亿美元，预计到2016年将达到46亿美元以上。此外，新的导管可以为医疗系统带来惊人的节省，因为每年用于治疗终末期肾病(ESRD)患者的290亿美元中有很大一部分专门用于管理血管通路的并发症？其中许多与导管有关，如严重感染、血栓形成和储备溶液丢失。如果成功，建议的项目应该会减少导管并发症，导致改善临床结果，提高患者满意度，并降低总体医疗成本。

This Small Business Innovation Research Phase I project will develop a novel hemodialysis catheter with an integrated distal valve that can be opened and closed from the proximal hub. Chronic hemodialysis catheter use is associated with significant complications such as infection, thrombosis and loss of lock solution. This novel device will be the first to provide clinicians with a tool to manage these complications. The research objectives include refining the design of the distal valve; refining the design of the proximal hub; and an in vitro assessment of lock solution loss and catheter thrombosis. The project will create and evaluate at least three distal valve design concepts, with the most promising prototype being optimized for performance and manufacturability. Proximal hub designs will be similarly evaluated and optimized. The final distal valve and proximal hub designs also will be validated and verified to ensure they meet product performance requirements. A published in vitro model will be used to study the final device?s ability to prevent loss of lock solution and its tendency for catheter thrombosis. The novel device is expected to have improved outcomes compared to standard catheters.The broader impact/commercial potential of this project is a disruptive, novel hemodialysis catheter for the vascular access device market, which was valued at over $3 billion in the U.S. in 2009 and is estimated to reach more than $4.6 billion by 2016. Furthermore, the new catheter could provide the healthcare system incredible savings because a significant portion of the $29 billion spent annually treating end-stage renal disease (ESRD) patients is dedicated to managing complications with vascular access ? many of which are associated with catheters, such as serious infections, thrombosis and loss of stock solution. If successful, the proposed project should reduce catheter complications, leading to improved clinical outcomes, higher levels of patient satisfaction and lower overall healthcare costs.