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.

尿失禁会影响大约2至300万美国男性。由于控制膀胱的神经系统损坏或由于前列腺肿大或其他医疗问题而导致的神经系统损坏，男性可能因前列腺手术而导致失禁。控制尿失禁的一种方法是使用外部夹具。这种设备会导致压力施加在尿道上，从而阻止尿液流过阴茎，但同时限制了血液流向器官。我们设计了一个独特的夹具，可防止尿液的非自愿损失，使用户快速，一只手释放用于排尿或去除，并且可以假设，可以使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的尿动力和血流测量。此外，我们建议确定这些设备在器官上的接触压力。拟议的商业应用：很难估算男性失禁夹具的年度使用，因为它是一个非常利基市场。据估计，该设备的零售价为30至50美元，可与当前设备相当。拟议装置的初始市场将是前列腺癌患者，在手术后2至24周内，有90％的人是无偶然的，然后我们将针对200万医学无私的男性。假设BEC的收入分别为10％和L％的市场渗透率将超过80万美元。