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

该小企业技术转让（STTR）第一阶段项目支持开发一种医疗器械，该医疗器械能够实现微创移植重建尿道，作为男性尿道狭窄的长期治疗，这是一类导致流量限制的疾病。每年大约有1%的男性接受医疗保险治疗狭窄，估计五分之一的男性在一生中会狭窄。尿道狭窄会使尿道逐渐变窄，导致尿急、尿频和尿痛，以及亲密关系受损。目前的实践状态有许多挑战：广泛使用的内窥镜治疗是简单和微创的，但很少治愈，复发率高，重复的内窥镜干预会使狭窄变窄，并将可治愈的疾病转变为慢性疾病，对生活质量造成破坏性后果。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选定的重建泌尿科医生进行的。拟议的医疗器械简化了微创移植物为基础的尿道重建，使一般泌尿科医生提供微创治疗treatment.The拟议项目的重点是证明一个临时留置尿道装置原型的抗迁移性能。该器械设计用于将移植物输送到尿道移植床，并在移植物粘附14天而不迁移时将其保持在适当位置。机械功能原型的概念验证研究将在实验室和体内进行，并通过集成专有的抗移位功能进一步推进。关键的里程碑包括原型的能力，以满足：有针对性的生物相容性/细胞毒性基准，抗迁移基准使用体外模型，并没有显着的迁移在体内超过14天periods.This奖项反映了NSF的法定使命，并已被认为是值得的支持，通过评估使用基金会的智力价值和更广泛的影响审查标准。

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.