Tape Mechanical Occlusive Device (TMOD)

描述（由申请人提供）：项目总结/摘要：GT Urological，LLC已准备了标题为“胶带机械闭合器械（TMOD）”的NIH SBIR I期资助申请，以详细说明与完全植入式机械驱动尿道闭合器械的设计和开发相关的目标和活动，该器械旨在安全有效地预防男性压力性尿失禁（SUI）患者的尿漏。SUI经常发生在接受手术切除癌性前列腺的男性中。与现有的尿失禁治疗相比，TMOD提供了显著的优势，现有的尿失禁治疗对排尿造成永久性部分阻塞或需要广泛的手术，如膨胀剂、尿道吊带和液压袖带。这些优点包括：1）旨在减少术中装置组装的单件式设计，2）简化和缩短外科手术，3）通过单个切口植入，4）减少尿道萎缩和糜烂，5）按需控制患者的失禁，6）尿道/膀胱/颈部周长小于2.5 cm的闭塞和7）微创手术以重新调整尿道狭窄程度，如果手术没有提供满意的结果。TMOD项目从工具阶段开始，进一步开发原型设计，然后进行制造。环氧乙烷灭菌过程将在授予期间进行确认，并用于TMOD器械灭菌，为生物相容性测试和验证与确认测试（包括慢性动物植入）做准备。将根据GT Urological，LLC质量体系程序创建TMOD质量标准，并将进行测试以确保器械符合功能和性能质量标准。将确定并构建夹具，以自动化需要大量性能或功能周期的测试。将无菌器械长期植入（3）只雌性杂种犬，以评估1）囊形成后激活/停用器械的能力，2）维持膀胱颈闭塞压力的能力和3）膀胱颈糜烂和组织损伤的可能性。在完成这些设计和开发步骤后，将向FDA提交试验用器械豁免（IDE）申请，以便开始人体临床试验。胶带机械封堵器（TMOD）项目叙述：胶带机械封堵器（TMOD）预期用于缓解约600万患有压力性和混合性尿失禁的美国男性。与目前用于治疗压力性和混合性尿失禁的技术相比，TMOD旨在提供功能和手术优势。

DESCRIPTION (provided by applicant): Project Summary/Abstract: 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) 1 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.