Semi-Automated Urethral Sphincter

半自动尿道括约肌

• 批准号: 6833912
• 负责人: WILLIAM R. KRAUSE
• 金额: $ 22.68万
• 依托单位: BIOENGINEERING CONSULTANTS, LTD
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2006-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6833912
• 关键词: assistive device /technology; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial development /preparation; biomaterial evaluation; biomedical automation; biomedical equipment development; biosensor device; medical implant science; miniature biomedical equipment; radio controlled electronic stimulator; urinary bladder sphincter disorder; urinary incontinence; urinary tract prosthesis; urination

DESCRIPTION (provided by applicant): Urinary incontinence is a common problem for the elderly affecting approximately 13 million Americans, 80 to 85 percent of them women (15-35% of all adult women) and 15 to 20 percent men (primarily post radical prostethomy). Nearly one third of community-dwelling adults and 750,000 nursing home residents have urinary incontinence. Usually after more conservative approaches have failed, implantation of an artificial urethral sphincter (AUS) is considered and only for patients with stress urinary incontinence. The Specific Aim of this proposal is to develop, prototype and evaluate an innovative semi-automatic artificial urinary sphincter (AUS) to be used to treat patients with urinary incontinence. Based on preliminary designs and stress evaluations, it is proposed to develop a semi-automated AUS using existing implantable pressure sensors, wireless signaling technology and shape memory alloy (SMA) biocompatible material. The system will monitor bladder pressure and then inform the user when it is time to urinate. The user will then use the control unit to signal the AUS to open and allow micturition. We will evaluate the AUS for longevity of the AUS device when subject to repeated on-off intervals replicating a year of usage. The system will be evaluated in an in-vitro urinary track model. We expect Phase II to proceed with animal trials and eventual human clinical trials.

描述（由申请人提供）：尿失禁是老年人的常见问题，影响着大约 1300 万美国人，其中 80% 至 85% 为女性（占所有成年女性的 15-35%），15% 至 20% 为男性（主要是根治性修复术后） ）。近三分之一的社区居住成年人和 750,000 名疗养院居民患有尿失禁。通常在更保守的方法失败后，才会考虑植入人工尿道括约肌（AUS），并且仅适用于压力性尿失禁患者。该提案的具体目标是开发、原型设计和评估一种创新的半自动人工尿道括约肌 (AUS)，用于治疗尿失禁患者。基于初步设计和应力评估，建议使用现有的植入式压力传感器、无线信号技术和形状记忆合金（SMA）生物相容性材料开发半自动化 AUS。该系统将监测膀胱压力，然后通知用户何时需要排尿。然后，用户将使用控制单元向 AUS 发送信号以打开并允许排尿。当重复一年的使用情况时，我们将评估 AUS 设备的使用寿命。该系统将在体外泌尿道模型中进行评估。我们预计第二阶段将进行动物试验和最终的人体临床试验。