GT Urological, LLC has prepared this NIH SBIR Phase I grant application entitled "Tape Mechanical Occlusive Device (TMOD)" to detail goals and activities related to the design and development of a totally implantable, mechanically actuated urethral occlusive device intended to safely and effectively prevent urinary leakage in males suffering from Stress Urinary Incontinence (SUI). SUI frequently occurs in males who have undergone surgery to remove their cancerous prostates. TMOD 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. These advantages include 1) one piece design intended to reduce intra- operative device assembly, 2) simplification and shortening of surgical procedure, 3) implantation through a single incision, 4) reduced urethral atrophy and erosion, 5) on- demand control of a patient's incontinence, 6) occlusion to urethral/bladder/neck circumferences lower than 2.5 cm and 7) a minimally invasive procedure to readjust degree of continence should surgery not have provided a satisfactory outcome. The TMOD project begins with a tooling phase to further develop a prototype design followed by manufacturing builds. Ethylene Oxide sterilization processes will be validated during the course of the grant and used to sterilize TMOD devices in preparation for biocompatibility testing and verification & validation testing which includes chronic animal implantation. TMOD specifications will be created in accordance with GT Urological, LLC Quality System Procedures and testing will be performed to insure the device's adherence to functional and performance specifications. Fixturing will be identified and built to automate testing requiring great numbers of performance or functional cycles. Sterilized devices will be implanted chronically in (3) female mongrel dogs to assess 1) ability to activate/deactivate the device following capsular formation, 2) ability to maintain bladder neck occlusive pressures and 3) potential for bladder neck erosion and tissue damage. Following completion of these design and development steps, an Investigational Device Exemption (IDE) submission to the FDA will be made to allow human clinical trials to begin. Tape Mechanical Occlusive Device (TMOD) Project Narrative The Tape Mechanical Occlusive Device (TMOD) is intended to provide relief to an estimated 6 million US men suffering from stress and mixed urinary incontinence. The TMOD is intended to provide functional and surgical advantages over current technologies used for the treatment of stress and mixed urinary incontinence.
Thesaurus Terms: Biomedical Equipment Development, Implant, Urethra, Urinary Incontinence Antiseptic Sterilization, Biomaterial Compatibility, Ethylene Oxide, Injection /Infusion, Temperature Dog, Medical Implant Science
