SBIR Phase II: Novel Peritoneal Dialysis Catheter to Reduce Infections

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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.