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）：对于影响约1300万美国人，其中80％至85％的女性（占所有成年女性的15-35％）和15％至20％的男性（主要是自由行化的前列腺切开术）的老年人，尿失禁是一个普遍的问题。在社区居住的成年人和750,000名养老院居民中，近三分之一患有尿失禁。通常，在更保守的方法失败后，考虑了人工尿道括约肌（AUS）的植入，仅适用于压力尿失禁的患者。该提案的具体目的是开发，原型和评估创新的半自动人造泌尿括约肌（AUS），用于治疗患有尿失禁的患者。根据初步的设计和应力评估，建议使用现有的可植入压力传感器，无线信号技术和形状内存合金（SMA）生物相容性材料开发半自动的AUS。系统将监视膀胱压力，然后在小便时通知用户。然后，用户将使用控制单元向AUS发出信号以打开并允许排尿。当重复的开关间隔复制一年的使用时，我们将评估AUS设备的寿命。该系统将在体外尿道模型中进行评估。我们预计第二阶段将继续进行动物试验和最终的人类临床试验。