PFI-TT: Initial proof of concept of a novel minimally invasive tool to address urethral narrowing

该PFI项目更广泛的影响/商业潜力是通过使尿道狭窄疾病（USD）患者能够接受根治性微创治疗，显着提高他们的生活质量。USD是泌尿道（尿道）狭窄，类似于疤痕组织带，引起疼痛和尿频。近1%的医疗保险男性寻求美元治疗，仅在美国，每年用于治疗的费用就超过3亿美元。目前这些患者的选择要么是复发率高的微创手术，要么是复杂的开放尿道重建手术——只有少数专家进行。许多被诊断为USD的患者反复接受微创治疗，使病情恶化；他们的生活围绕着下一次去洗手间的痛苦之旅。我们的创新将弥合这些方法之间的差距，使泌尿科医生能够通过微创尿道移植重建提供有效的治疗。这将使无法获得治疗的患者也能获得治疗。我可以接触到专业的外科医生，也可以接触到那些没有资格做长期复杂手术的人。拟议的项目将开发一个原型的微创手术工具，将完全集成。研究目标包括：构造解剖正确的尿道模型，迭代制造和测试器械子部件，将子部件集成到完整的器械中，在尿道模型中进行功能测试。子组件测试将包括测量在手术的各个步骤中施加在用于重建的移植物上的力，以确保最终的集成设备设计能够成功地提供移植物，并且在设备移除时不会对移植物造成损害。一旦子部件经过测试并根据需要进行修改，它们将被集成到完整的设备中，用于在尿道模型中测试功能。由此产生的集成原型将具有完整的功能，并准备在未来的动物模型试验研究中使用（超越PFI-TT）。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。

The broader impact/commercial potential of this PFI project is to dramatically improve the quality of life for men with urethral stricture disease (USD), by enabling them to undergo a curative minimally invasive treatment. USD is a narrowing of the urinary tract (urethra), similar to a band of scar tissue, causing painful and frequent urination. Nearly 1% of men on Medicare seek treatment for USD, and over $300 million is spent annually on treatment in the United States alone. Current options for these patients are either minimally invasive procedures with high rates of recurrence, or complex open reconstructive surgery of the urethra - only performed by small number of experts. Many patients diagnosed with USD undergo repeat minimally invasive treatments - worsening their condition; their lives revolve around the next painful trip to the restroom. Our innovation will bridge the gap between these approaches, allowing general urologists to provide effective treatment by performing graft reconstruction of the urethra minimally invasively. This will make treatment accessible to patients who don?t have access to an expert surgeon, and to those who are ineligible for a long complex surgery.The proposed project will develop a prototype for the minimally invasive surgical tool which will be fully integrated. Research objectives include: the development of an anatomically correct urethral model, iterative manufacture and testing of device sub-components, and integration of sub-components into the complete device for functional testing in the urethral model. Sub-component testing will include measuring the forces exerted upon the graft used for reconstruction during various steps of the procedure, to ensure that the final integrated device design can successfully deliver a graft, and not cause damage to the graft upon device removal. Once sub-components have been tested and modified as needed, they will be integrated into the complete device for testing functionality in the urethral model. The resulting integrated prototype will be fully functional, and be ready for use in a future pilot study in an animal model (beyond PFI-TT).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.