Validation of a Neurogenic Bladder Management Solution to Promote Independence and Reduce Long-Term Morbidity for Patients Unable to Perform Intermittent Catheterization

PROJECT SUMMARY/ABSTRACT The primary objectives of this SBIR Phase II project are to verify the surgical approach for device placement, finalize device design, and complete Design Validation and Verification testing to support 510k submission for the EZ-SP device. CRM Medical Devices developed the EZ-SP catheter as a bladder drainage system for those who cannot volitionally void, with a specific emphasis on assisting those with neurologic disease who have difficulties draining their bladder via clean intermittent catheterization (CIC), the act of placing a catheter through their urethra into the bladder for urinary drainage. Unfortunately, hundreds of thousands of men and women in the United States struggle to perform CIC due to either poor upper extremity motor function or difficulty accessing their urethra (most females). The EZ-SP device is a modified form-fitting catheter that spans from the bladder to the skin level of the lower abdomen and is initially placed via a simple, reversible, minimally invasive, 15-minute surgical procedure. By residing on the lower abdomen, the EZ-SP can be easily accessed while in a wheelchair and does not require time-consuming transfer to a commode or bed. It also reduces the social stigma that comes with indwelling catheter use, where a bladder drainage tube is always attached to a collection bag of urine and obviates the need for urethral catheterization, which can be traumatic. Simply, the EZ-SP catheter has a continence valve within it that can be mechanically opened for drainage when appropriate. To drain the bladder, a user attaches a “magnetic click connector” (that requires minimal UE motor function to connect) to a mechanical pump that removes urine from the bladder in a timely fashion and is then disconnected until the bladder is full again. After initial placement, subsequent monthly EZ-SP changes can be performed in an outpatient setting by simply deflating the retention balloon of the existing EZ-SP device, removing the device, and placing a new EZ-SP catheter through the existing scar tract from skin to bladder without further surgical intervention. In this Phase II project, we expect to complete the necessary testing to support the subsequent regulatory submission of the EZ-SP via a 510k process for market clearance in the United States and lay the groundwork for a clinical trial in a Phase IIb study. The end goal is to make this superior bladder management technology available to hundreds of thousands of men and women (regardless of upper extremity motor function) who rely on urinary catheterization.