SBIR Phase II: A Novel Disinfection Method to Prevent Infection in Peritoneal Dialysis

该小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是增加腹膜透析（PD）的可及性。美国每年有超过554，000名肾衰竭患者需要某种形式的透析，但只有58，000人接受PD，尽管其护理成本较低。尽管与中心透析相比，腹膜透析有许多益处和优势，但由于腹膜炎（腹膜感染）的风险，采用受到限制。腹膜炎每年发生在近30%的PD患者中，并且每6名接受PD的患者中就有1名死亡。该设备可显著降低腹膜炎的风险，从而节省近20亿美元的医疗保险费用，并改善临床效果。该小型企业创新研究（SBIR）二期项目将进一步开发一种医疗设备，可在封闭系统中对导管进行内部消毒。这种创新的消毒方法旨在防止腹膜透析期间的微生物感染威胁。目的是证明消毒原型的安全性和有效性，包括对其易用性的评价。该技术的设计将符合医疗器械设计和安全标准。该项目将进行优化研究，开发符合cGMP的制造工艺，并开发先进的原型。该奖项反映了NSF的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to increase access to peritoneal dialysis (PD). Over 554,000 kidney failure patients in the US require some form of dialysis each year but only 58,000 receive PD, despite its lower cost of care. Despite the many benefits and advantages of PD compared to in-center dialysis, adoption is limited due to the risk of peritonitis, an infection of the peritoneal membrane. Peritonitis occurs in nearly 30% of PD patients each year and is responsible for the death of 1 out of every 6 patients who receive PD. The proposed device significantly and broadly reduces the risk of peritonitis, resulting in nearly $2 billion in Medicare savings and improved clinical outcomes.This Small Business Innovation Research (SBIR) Phase II project will further develop a medical device that internally disinfects catheter tubes in a closed system. This innovative disinfection method is designed to prevent microbial infection threats during peritoneal dialysis. The aim will be to demonstrate the safety and efficacy of the disinfection prototype, including evaluations of its ease of use. The technology will be designed to meet medical device design and safety standards. The project will perform optimization studies, develop cGMP-ready manufacturing processes, and develop an advanced prototype.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.