STTR Phase I: Development of a Novel Minimally Invasive Reconstruction Device for the Treatment of Male Urethral Stricture Disease

这个小型企业技术转移（STTR）第一阶段项目支持一种医疗设备的开发，该设备可以实现基于移植物的微创尿道重建，作为男性尿道狭窄的长期治疗方法，尿道狭窄是一类导致血流受限的疾病。每年大约有1%的医疗保险男性接受狭窄治疗，估计五分之一的男性在他们的一生中会患上狭窄。尿道狭窄使尿道逐渐变窄，导致尿急、尿频和尿痛，并损害亲密关系。目前的实践状况存在许多挑战：广泛使用的内镜治疗方法简单，微创，但很少治愈，复发率高，反复的内镜干预使狭窄恶化，使可治愈的疾病变成慢性疾病，对生活质量造成毁灭性的后果。基于移植物的尿道重建具有良好的长期效果，但可用性有限，因为复杂的开放手术是由一组精选的重建泌尿科医生进行的。提出的医疗设备简化了微创移植尿道重建，使普通泌尿科医生能够提供微创治疗。提出的项目重点是展示一个临时留置尿道装置原型的抗迁移特性。该装置的设计目的是将移植物运送到尿道移植物床上，并在移植物附着的14天内固定它而不移动。机械功能原型的概念验证研究将在实验台上和体内进行，并通过集成专有的防迁移功能进一步推进。关键里程碑包括原型能够满足：靶向生物相容性/细胞毒性基准，使用体外模型的抗迁移基准，以及在14天内没有明显的体内迁移。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This Small Business Technology Transfer (STTR) Phase I project supports the development of a medical device that enables minimally invasive graft-based reconstruction of the urethra as a long-lasting treatment for male urethral stricture, a class of conditions causing restrictions in flow. Approximately 1% of men on Medicare are treated for stricture annually, and an estimated 1 in 5 men will get a stricture in their lifetime. A urethral stricture progressively narrows the urethra - leading to urinary urgency, frequent and painful urination, and impaired intimacy. The current state of practice has many challenges: Widely available endoscopic treatment is simple and minimally invasive but rarely curative, with high recurrence rates, and repeated endoscopic intervention worsens the stricture and turns a curable condition into a chronic disease, with devastating consequences to quality of life. Graft-based urethral reconstruction has excellent long-term outcomes but limited availability – as the complex open surgery is performed by a select group of reconstructive urologists. The proposed medical device simplifies minimally invasive graft-based urethral reconstruction to empower general urologists to deliver minimally invasive curative treatment.The proposed project focuses on demonstrating the anti-migration properties of a temporary indwelling urethral device prototype. The device is designed to deliver a graft to a urethral graft bed, and hold it in place as the graft adheres over a period of 14 days without migrating. Proof-of-concept studies of the mechanically functional prototype will be performed on the bench and in vivo, to be further advanced by integrating proprietary anti-migration features. Key milestones include the prototype's ability to meet: targeted biocompatibility/cytotoxicity benchmarks, anti-migration benchmarks using an in vitro model, and an absence of significant migration in vivo over a 14-day period.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.