SBIR Phase I: A Novel Valved Hemodialysis Catheter

该小型企业创新研究I期项目将开发一种新型血液透析导管，该导管具有可从近端座打开和关闭的集成远端阀。长期使用血液透析导管与感染、血栓形成和封管液丢失等严重并发症相关。这种新型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;改进近端导管座的设计;以及对封管液损失和导管血栓形成进行体外评估。该项目将创建和评估至少三个远端瓣膜设计概念，其中最有前途的原型将针对性能和可制造性进行优化。将对近端座设计进行类似评价和优化。还将对最终远端瓣膜和近端座设计进行确认和验证，以确保其符合产品性能要求。已发表的体外模型将用于研究最终器械？防止封管液流失的能力及其导管血栓形成的趋势。与标准导管相比，该新型器械预期具有更好的结局。该项目的更广泛影响/商业潜力是一种用于血管通路器械市场的颠覆性新型血液透析导管，2009年在美国的价值超过30亿美元，预计到2016年将超过46亿美元。此外，新的导管可以为医疗保健系统提供令人难以置信的节省，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用于管理血管通路的并发症。其中许多与导管有关，例如严重感染、血栓形成和原液损失。如果成功，拟议的项目应减少导管并发症，从而改善临床结果，提高患者满意度，降低整体医疗成本。

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.