Research Project
8525483
DESCRIPTION (provided by applicant): 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.
