SBIR Phase I: A Novel Device for Difficult Urethral Catheterization

The broader/commercial impact of this Small Business Innovation Research (SBIR) Phase I project addresses a critical issue with urinary catheters: difficult urethral catheterizations (DUC). Catheter insertion is among the most common medical procedures in the U.S., yet DUCs occur once every minute, leading to significant medical and financial burdens and frequently necessitating emergency urological consultation. Traumatic urethral catheterization (TUC), a complication of DUC, affects 2% or approximately 500,000 cases annually. The proposed system if successful will significantly improve catheter insertion, reduce infection risk, and enhance patient care quality. Its innovative design seeks to establish a new standard in urology, achieving high success rates without surgical intervention and provide a new standard of care for the $5.1 billion (projected 2028) urinary catheter market, positively impacting society and global health standards. This Small Business Innovation Research (SBIR) Phase I project will demonstrate the feasibility of a novel urinary catheter design which conforms to a wide range of individual human anatomies. This project will finalize catheter specifications, including flexibility, functionality, and material properties. State-of-the-art solid mechanics computational simulation will be employed to optimize insertion force, design, and overall functionality. Physical prototypes will be fabricated using medical device production techniques, followed by proof-of-concept testing utilizing a force gauge simulator. The key technical challenges to be addressed include maintaining structural integrity concurrent with increased flexibility, ensuring appropriate urethral fit, achieving scalable manufacturing, and successfully transitioning from a computational model to a physical prototype. The anticipated outcome is an optimized catheter design suitable for subsequent clinical studies and trials, with the primary objective of reducing morbidity associated with urinary catheterization procedures. 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.