I-Corps: TAURUS: Enabling a Minimally Invasive Treatment for Urethral Strictures

I-Corps：TAURUS：实现尿道狭窄的微创治疗

• 批准号: 1640778
• 负责人: Edward Wright
• 金额: $ 5万
• 依托单位: Johns Hopkins University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-06-01 至 2017-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1640778&HistoricalAwards=false
• 关键词: Corps; TAURUS; Enabling; Minimally; Invasive

A urethral stricture is a fibrotic narrowing of the urethra, which is like a band of scar tissue, which leads to voiding complications, drastically affecting the quality of life for men across the globe. This disease includes symptoms such as frequent and painful urination, penile inflammation, increased risk of urinary tract infection, and complications such as renal failure if not treated early enough. Existing options for patients with urethral strictures fall into two buckets: effective but invasive and complex open surgery (urethroplasty), and minimally invasive procedures (dilation, urethrotomy, or self-catheterization) with subpar outcomes. Patients typically begin with a minimally invasive treatment such as dilation or urethrotomy (stretching or cutting of the scar tissue), with a high chance of stricture recurrence. Patients often choose to repeat such treatments despite the short duration of effectiveness with their frontline urologist, rather than undergo the surgical procedure, which is performed by a trained reconstructive urologist. This I-Corps team, uCure, is developing TAURUS, a system to empower urologists to restore patient quality of life by replicating effectiveness and durability of urethroplasty, minimally invasively. This aims to offer a more desirable approach to reduce recurrences for patients, and making a financially incentivized treatment accessible to a wide range of urologists, resulting in cost effectiveness to payers and the health care system as a whole.uCure?s TAURUS facilitates the transurethral delivery of a graft, to widen the urethra at the site of stricture. The proposed project is in the proof of concept stage, iterating on early feasibility prototypes, and performing bench and preliminary animal tests in both post-mortem and live rabbits. This team has had discussions both with potential users, but also urologists across the globe who have attempted transurethral urethroplasty, mostly in the 1990s, but failed to gain adoption due to the complexity of the attempted procedures. Advances in multi-channel small lumen manufacturing and endoscopes now open the door to developing feasible, accessible, user-friendly devices for widespread commercial adoption. Through the I-Corps program, the proposed project benefits from technical and clinical de-risking, while swiftly iterating on solution design. The team is currently in discussion with 3rd party manufacturing resources to transform its proof of concept prototypes into alpha prototypes at scale for use in its animal studies. The team is planning to demonstrate early stage functional prototypes of the proposed TAURUS system at the end of the I-Corps program.

尿道狭窄是一种纤维性狭窄的尿道，就像一条疤痕组织，它会导致排尿并发症，严重影响全球男性的生活质量。这种疾病的症状包括尿频和尿痛、阴茎炎症、尿路感染风险增加，如果不及早治疗，还会出现肾功能衰竭等并发症。尿道狭窄患者的现有选择分为两类：有效但侵入性和复杂的开放手术（尿道成形术）和微创手术（扩张、尿道切开术或自我导尿），但效果较差。患者通常从微创治疗开始，如扩张或尿道切开术（拉伸或切割疤痕组织），狭窄复发的几率很高。患者经常选择重复这样的治疗，尽管他们的一线泌尿科医生的有效性持续时间很短，而不是接受外科手术，这是由训练有素的泌尿科医生进行的。这个名为uCure的I-Corps团队正在开发TAURUS系统，通过复制微创尿道成形术的有效性和持久性，使泌尿科医生能够恢复患者的生活质量。其目的是提供一种更理想的方法来减少患者的复发，并使广泛的泌尿科医生能够获得经济激励治疗，从而提高支付者和整个医疗保健系统的成本效益。金牛座有助于经尿道移植，扩大狭窄部位的尿道。拟议的项目正处于概念验证阶段，对早期可行性原型进行迭代，并在死后和活兔中进行实验和初步动物试验。这个团队不仅与潜在的用户进行了讨论，而且还与全球范围内尝试过经尿道尿道成形术的泌尿科医生进行了讨论，这些医生大多在20世纪90年代尝试过，但由于尝试过程的复杂性而未能获得采用。多通道小腔制造和内窥镜的进步现在为开发可行的、可访问的、用户友好的设备打开了大门，以广泛的商业采用。通过I-Corps计划，拟议的项目受益于技术和临床风险降低，同时快速迭代解决方案设计。该团队目前正在与第三方制造资源进行讨论，以将其概念验证原型大规模转化为用于动物研究的alpha原型。该团队计划在I-Corps项目结束时演示拟议的TAURUS系统的早期功能原型。