Electro-Mechanical Occlusive Device

描述(由申请人提供)：GT Urotics，LLC准备了NIH SBIR第一阶段批准申请，题为“机电闭塞器(EMOD)”，以详细说明与设计和开发完全可植入的、机电驱动的尿路闭塞器相关的目标和活动，该设备旨在安全有效地防止患有压力性尿失禁(SUI)的男性和女性的尿漏。自发性前列腺癌经常发生在接受了前列腺癌切除手术的男性中。女性经常因分娩受伤而大小便失禁。与现有的尿失禁治疗方法相比，EMOD具有显著的优势，现有的治疗方法会使排尿出现永久性的部分梗阻，或者需要进行广泛的手术，如扩张剂、尿路吊带和液压袖口。AMS AUS 800(R)是唯一市面上可以买到的液压袖带，它无法调整以适应压力事件引起的腹内压力变化，因此经常发生泄漏。EMOD的优点包括：1)对导致尿漏的腹内压力的实时变化作出反应；2)减少尿路萎缩和侵蚀；3)手术后非手术时可调整尿压，以适应不同程度的尿失禁。该提案的初步活动包括在明尼苏达大学机械工程系制造微电子机械系统(MEMS)射流泵。还将制造一个电子控制系统，以及相关的固件、尿路闭锁袖带和液体电容器。一旦制造完成，这些组件将使用台式技术和体外猪膀胱进行集成和调试。然后将进行一项急性的活体动物研究，以展示EMOD在应对模拟应激事件时防止尿液泄漏的能力。GT Urologic的意图是在本赠款范围之外进行额外的EMOD开发，这将导致EMOD商业化。电子机械闭塞设备(EMOD)项目简介电子机械闭塞设备(EMOD)旨在为大约1300万患有压力和混合性尿失禁的美国男性和女性提供缓解。EMOD旨在提供比目前用于治疗压力性和混合性尿失禁的技术更多的功能和手术优势。

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.