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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是通过增加腹膜透析（PD）的可及性来破坏肾脏替代治疗（RRT）。在美国，每年有超过500，000名肾衰竭患者需要RRT，只有52，000名患者接受PD治疗，尽管它的护理成本较低。由于腹膜炎的高发生率，腹膜炎的采用受到限制，每年超过30%的腹膜透析患者发生腹膜炎，并且每6例腹膜透析患者中就有1例死亡。该项目将降低PD感染风险，为当前患者提供更安全的护理，并使更多RRT患者接受PD治疗。这将为美国医疗保健系统每年节省超过1亿美元的腹膜炎相关住院费用。该小型企业创新研究（SBIR）第一阶段项目将评估为PD提供安全，易于操作的内部管道消毒方案的技术可行性，使其在非临床环境中更加实用。现有的预防导管相关感染的努力主要涉及教育和抗菌毂盖。然而，教育措施依赖于患者的依从性，并且抗菌帽使导管末端在移除进行治疗时容易受到污染。本项目旨在开发一种器械，该器械使用抗菌溶液在连接的腹膜透析系统内进行充分的微生物消毒。封闭系统中的消毒消除了二次污染事件的风险。然而，关于患者的腹部暴露于抗微生物溶液存在显著的问题。为了解决这一问题，将进行啮齿动物研究，以评价急性全身反应和抗菌剂残留物重复暴露于腹腔的风险。本研究旨在证明与透析液使用的现有影响相比，毒性风险足够低。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 I project is to disrupt renal replacement therapy (RRT) by increasing access to peritoneal dialysis (PD). Over 500,000 kidney failure patients in the United States (US) require RRT each year, with only 52,000 patients receiving PD, despite it having a lower cost of care. PD adoption has been limited due to high rates of peritonitis, which occurs in over 30% of PD patients each year and is linked to 1 out of 6 PD patient deaths. This project will reduce the risk of infection in PD, providing current patients with safer care and enabling more RRT patients to receive PD. This would save the US healthcare system over $100 million annually in peritonitis-related hospitalizations. This Small Business Innovation Research (SBIR) Phase I project will evaluate the technical feasibility of delivering a safe, easy-to-operate internal tube disinfection protocol for PD to make it more practical in non-clinical settings. Existing efforts to prevent catheter-associated infections largely involve education and antimicrobial hub caps. However, education measures rely on patient compliance and antimicrobial caps leave catheter ends vulnerable to contamination when removed for treatment. This project aims to develop a device that demonstrates sufficient microbial disinfection within a connected PD system using an antimicrobial solution. Disinfection in a closed system eliminates the risk of secondary contamination events. However, significant concerns exist with regards to exposure of the patient’s abdomen to the antimicrobial solution. To address this, rodent animal studies will be conducted to evaluate the acute systemic response and repeat exposure risk of antimicrobial residue to the peritoneal cavity. This study aims to demonstrate a sufficiently minimal toxicity risk compared to existing effects from dialysate solution use.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.