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

PFI-TT：解决尿道狭窄问题的新型微创工具概念的初步证明

• 批准号: 1827308
• 负责人: Edward Wright
• 金额: $ 19.99万
• 依托单位: Johns Hopkins University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2021-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1827308&HistoricalAwards=false
• 关键词: PFI; TT; Initial; proof; concept

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.

该PFI项目的更广泛的影响/商业潜力是通过使他们能够接受治愈性的微创治疗方法来大大改善尿道狭窄疾病（USD）男性的生活质量。美元是尿路（尿道）的变窄，类似于疤痕组织的带，导致痛苦和频繁的排尿。医疗保险的男性中，有将近1％的人寻求美元的治疗，仅在美国，每年就花费了超过3亿美元。这些患者的当前选择是侵入性的最低侵入性手术，复发率很高，或者是尿道的复杂开放重建手术 - 仅由少数专家进行。许多被诊断为美元的患者接受了重复的最低侵入性治疗 - 病情恶化；他们的生活围绕着下一次痛苦的厕所旅行。我们的创新将弥合这些方法之间的差距，从而使普通泌尿科医生能够通过最小化的尿道进行移植物重建，从而提供有效的治疗方法。这将使无法接触专家外科医生的患者可以接受治疗，并且对于那些没有资格进行长期复杂手术的患者。拟议的项目将为最小入侵的手术工具开发原型，该工具将完全整合。研究目标包括：开发解剖上正确的尿道模型，设备子组件的迭代制造和测试，以及将子组件集成到完整的设备中，以在尿道模型中进行功能测试。子组件测试将包括测量在过程的各个步骤中用于重建的移植物上施加的力，以确保最终的集成设备设计可以成功提供移植物，并且在拆卸设备时不会对移植物造成损害。一旦根据需要测试并修改了子组件，它们将集成到完整的设备中，以在尿道模型中测试功能。由此产生的集成原型将具有完全功能性，并准备在动物模型中的未来试点研究中使用（超越PFI-TT）。该奖项反映了NSF的法定任务，并被认为是值得通过基金会的智力优点评估的值得支持的和更广泛的影响审查标准。