SBIR Phase I: Cost-Effective Anastomotic System Featuring Compliant Anastomoses

这项小型企业创新研究（SBIR）第一阶段项目旨在开发一种机械系统，以促进血管吻合（端到端）技术的发展，从而实现快速、可重复的非穿透性、顺应性血管重建。这种一次性技术代表了比连续夹应用技术的进步，因为整个吻合口围是同时形成的，因此有利于血管重建。目前，市场上还没有一次性吻合系统，因此提出的技术将填补这一急需的需求。第一阶段的工作还将开发生产这些低成本吻合装置所需的制造方法，这些装置具有符合要求的聚氨酯夹。吻合器的台架试验将采用成熟的体外程序进行。该项目的更广泛影响/商业潜力将是减少进行血管吻合术所需的时间，以及在心脏跳动手术中进行血管重建。价值4亿美元的手术订书钉市场迫切需要一种新技术，因为开发一种新型的、无缝线的、同时应用10或12个环夹的吻合装置的需求尚未得到满足。这将导致快速商业化，特别是因为这种先进的系统将减少手术时间。

This Small Business Innovation Research (SBIR) Phase I project aims to develop a mechanical system for facilitating vascular anastomoses (end-to-side, end-to-end) technology that allows for the rapid and reproducible production of a non-penetrating, compliant vascular reconstruction. This one-shot technology represents a technical advance over the serial clip applier because the entire anastomotic circumference is formed simultaneously, thus facilitating the vascular reconstruction. Currently, there are no one-shot anastomotic systems on the market, thus the proposed technology would fill that much needed demand. This Phase I effort also will develop the manufacturing methods needed to produce these low-cost anastomotic devices that feature compliant polyurethane clips. Bench testing of the anastomoses will be conducted using well-established in vitro procedures.The broader impact/commercial potential of this project will be to reduce the time required to perform vascular anastomoses as well as vascular reconstruction in beating heart surgery. The $400 million surgical staples market urgently needs a new technology, as there is a significant unmet need to develop a novel, sutureless anastomotic device that applies 10 or 12 circumferential clips simultaneously. This should lead to rapid commercialization, especially since this advanced system will reduce surgical operating time.