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.

项目概述/摘要：GT Urological， LLC准备了这份名为“Tape Mechanical Occlusive Device （TMOD）”的NIH SBIR第一期拨款申请，详细介绍了与设计和开发一种完全植入式机械驱动的尿道闭塞装置相关的目标和活动，旨在安全有效地预防男性压力性尿失禁（SUI）的尿漏。SUI经常发生在接受手术切除癌前列腺的男性身上。与现有的尿失禁治疗方法相比，TMOD具有显著的优势，现有的尿失禁治疗方法会造成永久性的部分排尿障碍，或者需要大量的手术，如填充剂、尿道吊带和液压套。这些优点包括：1)一体式设计旨在减少术中装置的装配，2)简化和缩短手术过程，3)通过单个切口植入，4)减少尿道萎缩和糜蚀，5)按需控制患者的尿失禁，6)阻断尿道/膀胱/颈部周长低于2.5 cm, 7)如果手术不能提供满意的结果，可以通过微创手术重新调整尿失禁程度。TMOD项目从工具阶段开始，进一步开发原型设计，然后进行制造构建。环氧乙烷灭菌工艺将在批准过程中进行验证，并用于TMOD器械的灭菌，为生物相容性测试和验证和验证测试做准备，包括慢性动物植入。TMOD规格将根据GT Urological， LLC质量系统程序创建，并进行测试以确保设备符合功能和性能规格。夹具将被识别和构建，以自动测试需要大量的性能或功能周期。经过消毒的装置将被长期植入(3)雌性杂种狗体内，以评估1)在囊膜形成后激活/停用该装置的能力，2)维持膀胱颈部闭塞压力的能力，以及3)膀胱颈部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提交研究器械豁免（IDE），以允许开始人体临床试验。胶带机械闭塞装置（TMOD）项目简介：胶带机械闭塞装置（TMOD）旨在缓解美国约600万患有压力和混合性尿失禁的男性。TMOD旨在为治疗压力和混合性尿失禁提供功能和手术上的优势。