Feasibility, Pilot, and Communication studies towards Translation of Aurie Reusable Catheter System into Clinical Practice.

Enter the text here that is the new abstract information for your application. This section must be no longer than 30 lines of text. 600,000 people in the US rely on intermittent catheterization (IC) for bladder emptying, but current IC products not adequately meet users’ needs. CathBuddy, Inc. has developed a novel IC system that is safely reusable, with an automated, validated method to clean, disinfect and lubricate catheters for re-use. The objective of this SBIR Phase II project is to modify the design of the 16” Aurie Reusable Catheter System (developed first due to increased technical difficulty and use by both male and female IC users) to a 6” system (preferable for many female IC users and needed to enhance widespread appeal and recruitment for clinical studies). Patients with neurogenic bladder (NB) are often unable to void spontaneously and require self-administered IC multiple times each day. Current guidelines recommend the use of a new single-use catheter with each catheterization, a practice adopted to reduce infection risk, although IC still contributes to a 50% annual complicated urinary tract infection risk. No-touch catheters reduce this infection risk by 44.5% with features including introducer tips and insertion sleeves that reduce the likelihood of contact contamination, but they are often prohibitively expensive on a per-use basis and only 5% of the user population can access them. These factors have led to CathBuddy, Inc.’s development of a safely reusable no-touch urinary catheterization system that alleviates many of the documented obstacles in IC with a specific focus on human factors and ease-of-use through a no-touch design. By incorporating a personal portable washer-disinfecting carrying case for use by the individual into this novel catheterization system, the notouch catheters can be safely reused on-the-go, and per-use costs drop dramatically. In addition, plastic waste from catheterization can be reduced by up to 85%. In this Phase II project, 1) the existing 16” system will be modified to incorporate 6” catheterspecific design requirements. Modification of the 16” system will require first evaluating the decrease in fluid volume requirements between the two catheter lengths; this will be translated into smaller supply needs, smaller batteries (for onboard pumps), and a smaller overall footprint. This effort will culminate in the development of an alpha prototype of the female system that can be used in future efforts for FDArequired Verification and Validation testing.