Approximately 1 in 5 people who are hospitalized receive a urinary catheter. In the US alone, there are over 30 million urinary catheters used annually, and they are the #1 source of hospital-associated infections. Not only are these infections painful for the patient, the infections are not covered by insurance and are expensive for the hospital to remedy. Furthermore, the necessity to treat these infections has contributed to the rise of antibiotic-resistant organisms. The proposed ground-breaking, antifouling catheter technology is a new approach to battle infections that on-demand "squeezes" out bacteria that grow inside of the catheter (without affecting the external dimensions of the catheter or patient comfort). This mechanical approach is new, avoids the pitfalls of ineffective previously attempted chemical and biologic approaches, and is poised to revolutionize the long-stagnant catheter market. The technology takes advantage of current materials and manufacturing capabilities, which is important since urinary catheters are typically a low-cost, high-volume product. Overall, demonstrating that this new antifouling catheter is clinically effective would reduce the total cost of home care and be a "big win" for acute care of patients, clinicians, hospitals, long-term care facilities and insurance agencies.
In the United States, approximately $15 billion are spent annually tomanage and remove biofilms. While the antifouling approach in this project has general utility, the proposed specific application, an antifouling urinary catheter, represents a particularly important problem to address. This I-Corps team has developed an anti-biofilm technology that uses inflating elastic chambers (like those of soft robotic machines) in the walls of the catheter to selectively generate surface deformation on the inner (urine-carrying) lumen of the catheter to remove biofilms and thereby reduce infection. The team plans to develop clinical feasibility data using silicone-based multi-lumen antifouling catheter prototypes in a pilot study (funded by the Duke Coulter Translational Program) to establish the efficacy of our catheter technology, enhance the value of the related IP, and advance towards commercialization. The team has already generated compelling proof-of-concept in vitro data demonstrating that to-scale silicone catheter shafts remove almost all of a model mixed-bacterial community biofilm from the interior surface of the catheter. This team has also received intense interest from catheterized patients as well as from catheter manufacturers. During the I-Corps program, customer interviews will allow a better market understanding of defining advantages, high impact areas (e.g., intensive care vs. long term care), specific catheter type (suprapubic vs. Foley catheters), and also allow the team to evaluate other potential applications for this platform technology. This project will aid in developing a startup commercialization plan as well as in negotiating with potential licensee catheter manufacturers.
