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

这个小企业技术转移(STTR)第一阶段项目支持开发一种医疗设备，该设备能够以微创的基于移植物的重建尿路作为男性尿路狭窄的长期治疗方法，这是一种导致血流受限的疾病。在接受联邦医疗保险的男性中，每年大约有1%的人会因狭窄而接受治疗，估计五分之一的男性会在一生中受到狭窄的治疗。尿路狭窄会逐渐使尿路变窄--导致尿急、尿频和排尿疼痛，以及亲密关系受损。目前的实践状态面临着许多挑战：广泛可用的内窥镜治疗简单且微创，但很少能治愈，复发率高，反复的内窥镜干预会加剧狭窄，将可治愈的疾病转变为慢性病，对生活质量造成毁灭性后果。基于移植物的尿路重建术有很好的长期效果，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。拟议中的医疗设备简化了基于移植物的微创尿路重建，使普通泌尿科医生能够提供微创治疗。拟议的项目重点展示了临时留置尿路装置原型的防移行特性。该装置的设计目的是将移植物输送到尿路移植物床上，并在移植物粘连14天而不迁移的情况下将移植物固定到位。机械功能原型的概念验证研究将在试验台上和体内进行，并将通过集成专有的反迁移功能进一步推进。关键的里程碑包括原型达到目标生物兼容性/细胞毒性基准的能力，使用体外模型的抗迁移基准，以及14天内体内没有重大迁移。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.