Electro-Mechanical Occlusive Device

DESCRIPTION (provided by applicant): GT Urological, LLC has prepared this NIH SBIR Phase I grant application entitled "Electro Mechanical Occlusive Device (EMOD)" to detail goals and activities related to the design and development of a totally implantable, electro-mechanically actuated urethral occlusive device intended to safely and effectively prevent urinary leakage in males and females suffering from Stress Urinary Incontinence (SUI). SUI frequently occurs in males who have undergone surgery to remove their cancerous prostates. Females frequently become incontinent due to child birth injury. EMOD offers significant advantages over existing urinary incontinence treatments that impart a permanent partial obstruction to voiding or require extensive surgery such as bulking agents, urethral slings and hydraulic cuffs. The only commercially available hydraulic cuff, the AMS AUS 800(r) is unable to adjust to accommodate changes in intra-abdominal pressure induced by stressful events and leakage frequently occurs. EMOD advantages include 1) responsiveness to real-time changes in intra-abdominal pressure leading to urinary leakage, 2) a reduction in urethral atrophy and erosion and 3) non-surgical, post- operative adjustability of urethral pressure to accommodate changing degrees of urinary incontinence. Preliminary activities in this proposal include fabrication of a Mico Electo Mechanical Systems (MEMS) Fluidic Pump at the University of Minnesota, Department of Mechanical Engineering. An Electronic Control System with associated firmware, a Urethral Occlusive Cuff and Fluid Capacitor will also be fabricated. Once fabricated, the components will be integrated and debugged using on-bench techniques and ex-vivo porcine bladders. An acute, live animal study will then be performed to display the EMOD's ability to prevent urine leakage in response to simulated stress events. It is GT Urological's intent to perform additional EMOD development beyond the scope of this grant which will lead to EMOD commercialization. Electro Mechanical Occlusive Device (EMOD) Project Narrative The Electro Mechanical Occlusive Device (EMOD) is intended to provide relief to an estimated 13 million US men and women suffering from stress and mixed urinary incontinence. The EMOD is intended to provide functional and surgical advantages over current technologies used for the treatment of stress and mixed urinary incontinence.