Urological Clamp for Incontinence

尿失禁泌尿外科钳

• 批准号: 6404811
• 负责人: WILLIAM R. KRAUSE
• 金额: $ 9.95万
• 依托单位: BIOENGINEERING CONSULTANTS, LTD
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-15 至 2003-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6404811
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; blood flow measurement; fluid flow; human subject; male; mechanical pressure; prostate neoplasms; urethra; urinary incontinence; urination

Urinary incontinence affects an estimated 2 to 3 million American men. Men can become incontinent as the result of prostate surgery due to damage of the nervous system controlling the bladder or have leakage due to an enlarged prostate or other medical problems. One method of controlling incontinence is the use of external clamps. Such devices cause pressure to be applied upon the urethra, which consequently stops the flow of urine through the penis but at the same time restricts blood flow to the organ. We have designed a unique clamp that prevents the involuntary loss of urine, allows the user quick, one handed release for voiding or removal and, it is hypothesized, allows adequate blood flow to prevent ischemia. We propose to perform standard urodynamic and blood flow measurements on incontinent males using our device and other commercially available devices. In addition we propose to determine the contact pressure of these devices on the organ. PROPOSED COMMERCIAL APPLICATIONS: It is very difficult to estimate the annual usage of male incontinent clamps as it is a very niche market. It is estimated that the device would retail in the $30 to $50 range, comparable to current devices. The initial market for the proposed device will be the prostate cancer patient of whom 90% are incontinent for 2 to 24 weeks post surgery after which we will target the 2 million medically incontinent men. Assuming a 10% and l% market penetration, respectively, BEC's revenues would exceed $800,000.

据估计，有 2 至 300 万美国男性患有尿失禁。由于控制膀胱的神经系统受损，男性可能会因前列腺手术而失禁，或者因前列腺肥大或其他医疗问题而出现渗漏。控制失禁的一种方法是使用外部夹子。这种装置会对尿道施加压力，从而阻止尿液流过阴茎，但同时限制血液流向该器官。我们设计了一种独特的夹子，可以防止尿液不自觉流失，允许使用者快速、单手释放以排尿或取出，并且据推测，可以允许足够的血液流动以防止缺血。我们建议使用我们的设备和其他市售设备对失禁男性进行标准尿动力学和血流测量。此外，我们建议确定这些装置对器官的接触压力。拟议的商业应用：很难估计男性失禁夹的年使用量，因为这是一个非常利基的市场。据估计，该设备的零售价为 30 至 50 美元，与当前设备相当。该设备的最初市场将是前列腺癌患者，其中 90% 的患者在手术后 2 至 24 周内会失禁，之后我们将瞄准 200 万因医学原因失禁的男性。假设市场渗透率分别为 10% 和 1%，BEC 的收入将超过 800,000 美元。