In today's device world, products must address soaring healthcare costs under the increased scrutiny of quality and safety. By addressing patient safety, we believe costs can be reduced and quality improved. Non-infectious urethral catheter related complications are one such patient safety problem the US and worldwide health care industry faces. Urethral catheters are placed in nearly 20% of U.S. hospitalized patients- nearly 8 million patients. From 2006 to 2008 we identified nearly 110,000 urethral catheter-related injuries using the Federal Government's Healthcare Cost and Utilization Project database.(1) These injuries and the associated short and long-term complications pose significant morbidity to patients, and burden to the healthcare systems. Urinary catheters have a mechanism to inflate a retention balloon within the bladder and an outflow port to allow urine to escape. When the retention balloon is inflated within the narrow lumen of the urethra a great deal of damage can be done to the patient. The exact incidence of this type of iatrogenic injury is not precisely known because it is poorly documented. Nearly 4 million men hospitalized per year in the U.S. undergo urethral catheterization. Of those patients we estimated that around 1 in 500 suffer urethral trauma due to catheterization based upon nationally representative administrative data from the National Inpatient Sample(2). The current cost for treating these adverse events is approximately $2888 per patient. Research at UCSF conducted by our group on human cadavers (3), resulted in patent application for a safer urethral catheter design, which was licensed by our company. Because urinary catheters today are a commoditized product, the commercial success of a safer catheter system is only possible with a pricing structure that fits within the current reimbursement guidelines. We believe that urethral catheter-related injuries can be greatly reduced by simple adaptations to the existing urinary catheter design with little to no additional cost.
The aims of this proposal are to: (1) identify the threshold pressureat which our device will be activated to mitigate urethral damage and notify the end-user of incorrect catheter placement (2) prototype a cost equivalent safer urethral catheter based upon our licensed intellectual property;(3) test these prototypes in ex vivo and animal models to further hone the parameters of our catheter designs and preliminarily demonstrate proof of concept of their efficacy.

Public Health Relevance

This application describes the need for a safer urinary catheter and a potential design to reduce urinary catheter related injuries in patients. In this application, we propose the development of prototype urinary catheters based upon our patent pending IP in order to assess efficacy and optimize manufacturing cost and methodology. In addition, we plan to test this device in animal models to assess efficacy at preventing urethral damage.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Small Business Technology Transfer (STTR) Grants - Phase I (R41)
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Special Emphasis Panel (ZRG1-DKUS-G (13))
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Kirkali, Ziya
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Safe Medical Design, LLC
San Francisco
United States
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