Tape Mechanical Occlusive Device (TMOD)

胶带机械闭塞装置 (TMOD)

• 批准号: 7217724
• 负责人: GERALD W. TIMM
• 金额: $ 46.08万
• 依托单位: GT UROLOGICAL, LLC
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7217724
• 关键词: antiseptic sterilization; biomaterial compatibility; biomedical equipment development; dogs; ethylene oxide; implant; injection /infusion; medical implant science; temperature; urethra; urinary incontinence

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.

描述（由申请人提供）： 项目摘要/摘要：GT Urological, LLC 准备了这份题为“胶带机械闭塞装置 (TMOD)”的 NIH SBIR 第一阶段拨款申请，以详细说明与完全植入式设计和开发相关的目标和活动，机械驱动的尿道闭塞装置，旨在安全有效地防止患有压力性尿失禁 (SUI) 的男性漏尿。 SUI 经常发生在接受癌性前列腺切除手术的男性身上。与现有的尿失禁治疗相比，TMOD 具有显着的优势，现有的尿失禁治疗会对排尿造成永久性部分阻塞或需要大量手术，例如填充剂、尿道吊带和液压套囊。这些优点包括 1) 一体式设计旨在减少术中装置组装，2) 简化和缩短手术过程，3) 通过单个切口植入，4) 减少尿道萎缩和糜烂，5) 按需控制患者失禁，6) 尿道/膀胱/颈围小于 2.5 厘米的闭塞，以及 7) 重新调整失禁程度的微创手术如果手术不能提供令人满意的结果，则应节制。 TMOD 项目从模具阶段开始，进一步开发原型设计，然后进行制造。环氧乙烷灭菌工艺将在拨款过程中进行验证，并用于对 TMOD 设备进行灭菌，为生物相容性测试以及验证和验证测试（包括慢性动物植入）做准备。 TMOD 规格将根据 GT Urological, LLC 质量体系程序创建，并进行测试以确保设备符合功能和性能规格。将识别和构建夹具以实现需要大量性能或功能循环的自动化测试。无菌装置将长期植入 (3) 只雌性杂种狗体内，以评估 1) 囊膜形成后激活/停用装置的能力，2) 维持膀胱颈闭塞压力的能力，以及 3) 膀胱颈糜烂和组织损伤的可能性。完成这些设计和开发步骤后，将向 FDA 提交研究设备豁免 (IDE) 申请，以便开始人体临床试验。胶带机械闭塞装置 (TMOD) 项目简介：胶带机械闭塞装置 (TMOD) 旨在缓解大约 600 万患有压力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。