PFI-TT: Development and Evaluation of an Absorbable Surgical Adhesive Patch to Reinforce Internal Suture Lines in the Urinary Tract

这一创新技术转化伙伴关系(PFI-TT)项目的更广泛影响/商业潜力将是创造一种灵活的、可生物吸收的内部缝合加固装置，以显著减少术后并发症和再入院，降低住院成本，并提高患者的生活质量。这种装置的使用预计将减少20%的总并发症和再入院，导致每次手术平均节省5600美元。该项目将对组织上的材料进行评估，并对组织和材料进行数字建模，以用于快速设备原型制作。外科医生的反馈将被用来进一步迭代原型，以确保它是一个易于应用的闭合系统，为外科医生的使用进行了优化。拟议的项目将开发一种可生物降解的、可植入的外科闭合装置，旨在持续可靠地支撑和固定缝合线，从而促进伤口愈合，无论组织质量和/或外科医生的经验如何。该设备的初步开发将用于尿路重建(UTR)手术，包括复杂的下尿路重建(LUTR)，如膀胱重建，前列腺手术后的组织闭合，以及上尿路重建，如输尿管手术，以促进肾脏重建后的引流。例如，LUTR术需要很长的缝合线，需要丰富的技能和经验，以最大限度地减少术后并发症。此外，在这些情况下，由于老化、辐射或纤维化，组织通常是不理想的。开发的缝合加强装置寻求提供一种技术解决方案，旨在通过加强组织和消除缝合线上的局部张力来减少并发症和再入院。该装置的设计将通过加强外科医生已经使用的缝合线来支持既定的组织闭合方法。拟议的设备不会显著改变关闭工作流程，因此，将最大限度地减少与使用设备最大化采用相关的任何潜在学习曲线。该奖项反映了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。

The broader impact/commercial potential of this Partnerships for Innovation - Technology Translation (PFI-TT) project will be to create a flexible, bioabsorbable, internal suture reinforcement device to significantly reduce post-operative complications and readmissions, decreasing hospitalization costs, and improving patient quality of life. The use of this device is anticipated to decrease total complications and readmissions by 20%, resulting in an average savings of $5,600 per procedure. This project will both evaluate the materials on tissue and digitally model tissue and materials for rapid device prototyping. Surgeon feedback will be used to further iterate the prototype to ensure that it is a readily applied closure system, optimized for surgeon use.The proposed project will develop a biodegradable, implantable, surgical closure device designed to consistently and reliably support and secure suture lines thereby promoting wound healing, regardless of tissue quality and/or surgeon experience. The initial development of this device will be for urinary tract reconstructive (UTR) procedures, including complex lower UTR (LUTR) such as bladder reconstruction, tissue closures following prostate surgery, and upper UTR such as ureteral procedures to facilitate drainage following kidney reconstruction. LUTRs, for example, involve long suture lines requiring significant skill and experience to minimize the post-operative complications. Additionally, in these cases, the tissue is often suboptimal resulting from aging, radiation, or fibrosis. The suture reinforcement device developed seeks to provide a technical solution designed to reduce complications and readmissions by reinforcing tissue and removing localized tension from the suture lines. The device will be designed to support the established method of tissue closure by reinforcing the suture lines already utilized by the surgeons. The proposed device would not significantly change the closure workflow and thus, would minimize any potential learning curve associated with the use of the device maximizing adoption.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.