PFI-RP: Temporary implantable device to perform minimally invasive urethral reconstruction; meeting engineering challenges for transition to small-volume production manufacturing.

该创新-研究伙伴关系（PFI-RP）项目的更广泛影响/商业潜力将解决患有尿道狭窄疾病的美国男性的泌尿系统健康问题。这种情况会导致尿流阻塞，并可能导致感染，疼痛和损害膀胱和肾脏。现有的治疗方法并不是最佳的。目前的内镜治疗（狭窄切开或扩张）相对简单，但复发率高。开放手术是有效的，但往往需要组织移植，是技术上具有挑战性，耗时和不容易获得。结合这些治疗策略的最佳效果需要一种生物工程解决方案，利用对尿道生理学、材料科学、伤口愈合和机械小型化的理解。开发一个完成内窥镜微创尿道移植重建的平台将简化患者和外科医生的复杂手术，提高这种新技术在更广泛的地区和社会经济范围内的可及性和可用性。这种工具将降低护理成本，同时最大限度地减少每年治疗这种复杂和衰弱疾病的大约30万美国男性的康复。拟议项目分三个阶段解决了对用于治疗尿道狭窄疾病的微创组织移植系统的需求：1）开发一种装置，以将组织移植物固定到狭窄部位的尿道内部，并确保在一系列工程测试平台上的输送和固定规范; 2）进行以安全性为中心的临床前验证，包括生物相容性试验和狭窄的结局评价-诱导大型动物模型，将临时植入物留在原位而不迁移，直到植入完成，使尿道口径恢复;和3）开发小批量生产工艺，随后制造和测试所得植入物。这个PFI-RP项目的产出将是一个原型系统。这个奖项反映了NSF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。

The broader impact/commercial potential of this Partnerships for Innovation – Research Partnerships (PFI-RP) project will address the urological health of American men suffering from urethral stricture disease. This condition causes blockage of urine flow and can lead to infection, pain, and damage to the bladder and kidneys. Existing treatments are not optimal. Current endoscopic management (stricture incision or dilation) is relatively simple to perform but has a high recurrence rate. Open surgery is effective but often requires tissue grafting and is technically challenging, time consuming and not readily accessible. Combining the best of these treatment strategies requires a bioengineering solution leveraging understanding of urethral physiology, material science, wound healing and mechanical miniaturization. Developing a platform to accomplish endoscopic minimally invasive urethral graft reconstruction will simplify an otherwise complex procedure for both patients and surgeons, improving access and availability of this novel technology across a wider regional and socioeconomic spectrum. This tool will decrease cost of care while minimizing recovery for the roughly 300,000 American men treated annually for this complex and debilitating condition. The proposed project addresses the need for a minimally invasive tissue grafting system for treating urethral stricture disease in three phases: 1) Develop a device to secure a tissue graft to the interior of the urethra at the site of stricture and ensure delivery and fixation specifications across an array of engineered testing platforms; 2) Conduct safety-focused preclinical validation, including biocompatibility testing and outcome evaluation in a stricture-induced large animal model with a temporary implant left in place without migration until engraftment is complete, leaving the urethral caliber restored; and 3) Develop a small volume production process, followed by fabrication and testing of the resulting implants. The output of this PFI-RP project will be a prototype system.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.