SBIR Phase II: Novel Peritoneal Dialysis Catheter to Reduce Infections

这个小型企业创新研究(SBIR)第二阶段项目旨在通过开发一种新的腹膜透析(PD)导管连接的消毒工艺来减少与PD相关的感染，从而提高透析患者的生活质量。帕金森病患者中帕金森病的患病率正在增加，感染率已成为关键改善的目标。由于帕金森病是一种自我给药治疗，患者遵守设置方案对于确保遵守无菌至关重要。不幸的是，情况并不总是如此--感染仍然是一个紧迫的问题。这项研究的目的是为了避免患者完全依从性的需要，并引入一种设备，对最有可能受到污染的PD导管接口进行去污。研究目标集中在加强装置的设计，以努力实现对多种病原体的多重对数细菌减少，包括细菌和真菌。这个项目的其他目标是从性能和可用性的角度优化产品设计。当该消毒装置投入临床使用时，将使腹膜透析患者能够安全地获得与这种治疗模式相关的全部好处。该项目更广泛的影响/商业潜力是为所有在港口遭受导管相关感染的导管制定一种新的护理标准。透析、中心静脉和外周静脉管道的总潜在市场价值为130亿美元。导管相关感染仍然是许多市场的一种危险的健康危害，到目前为止，还没有出现能够成功解决这一问题的消毒剂。近年实施的“无报酬”规定，防止医院因使用导尿管而感染个案而获得补偿。该消毒装置可使导尿管净化，预防管腔感染，从而大大降低二次感染的风险。尤其是腹膜透析，这项技术通过增加安全性、降低患者发病率和死亡率，使家庭透析成为比血液透析更具吸引力的选择，同时允许更多的患者利用腹膜透析提供的生活质量好处。

This Small Business Innovation Research (SBIR) Phase II project is aimed at improving the quality of life of dialysis patients through the development if a new disinfection process of the peritoneal dialysis (PD) catheter connection that will reduce infections related to PD. The prevalence of PD among dyaliss patients is increasing and infection rate has become a target for critical improvement. Since PD is a self-administered treatment, patient adherence to the set-up protocol is vital to ensure that sterility is observed. Unfortunately, this is not always the case - infection remains a pressing concern. The objective of this research is to circumvent the need to for complete patient compliance, and introduce a device that will decontaminate the interfaces of PD catheters that are at most risk of contamination. Research objectives focus on enhancing the device design in an effort to achieve a multifold logarithmic bacterial reduction on multiple pathogens, including bacterial and fungal. Other objectives of this project are to optimize product design, from both performance and usability standpoints. When implemented into the clinic, the disinfection device will allow peritoneal dialysis patients to safely receive the full benefit associated with this mode of treatment. The broader impact/commercial potential of this project is to develop a new standard of care for all catheters suffering from catheter-related infections at ports. The total addressable market for dialysis, central venous, and peripheral venous lines is $13 Billion. Catheter-related infections still presents as a dangerous health hazard for many markets and as of yet, no disinfectant has emerged to successfully address this issue. The "No Pay" rule implemented in recent years prevents hospitals from being reimbursed from infection-related cases with catheters. The disinfection device will enable the decontamination of catheters and the prevention of luminal infections, thereby greatly reducing the risk of secondary infection. For peritoneal dialysis specifically, this technology allows for home dialysis to be a more attractive option compared to hemodialysis by adding safety, reducing patient morbidity and mortality, while permitting more patients to take advantage of the quality of life benefits that peritoneal dialysis provides.