Anastomotic Device for Large Vascular Grafts

描述（由申请人提供）：这个项目的目标是基于一种新颖的订阅机设计，开发一种用于大血管和血管移植的通用吻合装置。该装置的使用可以为目前的手工缝合方法提供一种替代方法，具有更好和更可重复性的吻合口的潜力，并且减少了交叉夹紧或旁路时间要求。该装置的直接应用是在移植物/插管与主动脉之间进行端侧吻合，例如，作为VAD的流出管。在项目的第一阶段，将通过离体和急性体内研究设计、制造和表征一个可行性原型。基于I期研究的成功，II期项目将专注于开发具有集成功能的工具，慢性体内生物相容性研究，以及易于使用和制造的设计优化。公共卫生相关性：该吻合器可提高大血管吻合质量，缩短手术时间。有许多外科应用可能受益于快速和可重复的方法放置大（即大于5毫米直径）的合成血管移植物，特别是减少出血并发症的方法。这些包括心室辅助装置（VAD）植入，肾透析动静脉（AV）瘘放置，主动脉弓重建和腹主动脉瘤（AAA）修复。仅在美国，这种血管吻合器每年就可应用于10万例手术。

DESCRIPTION (provided by applicant): The objective of this proposed program is to develop a general purpose anastomotic device for large vessels and vascular grafts, based on a novel stapler design. The use of the device can provide an alternative procedure to the current manual suturing methods, with the potential of yielding anastomoses having better and more reproducible performance, and with reduced cross-clamping or bypass time requirements. The immediate application of this device is in making an end-to-side anastomosis between a graft/cannula and the aorta, for example, as the outflow conduit for a VAD. Under Phase I of the program, a feasibility prototype will be designed, fabricated, and characterized via both ex vivo and acute in vivo studies. Based upon the success of our Phase I studies, Phase II of the program would focus on the development of a tool with integrated functions, chronic in vivo studies for biocompatibility, and design optimization for ease of use and manufacturing. PUBLIC HEALTH RELEVANCE: The stapler will improve the quality of large vascular anastomoses and reduce the operating time requirements. There are numerous surgical applications that could benefit from a rapid and repeatable method of placing large (i.e. greater than 5 mm diameter) synthetic vascular grafts, especially a method that reduces the rate of bleeding complications. These include ventricular assist device (VAD) implantation, arteriovenous (AV) fistula placement for renal dialysis, aortic arch reconstruction, and abdominal aortic aneurysm (AAA) repair. This vascular stapler may be applicable to 100,000 procedures per year in the U.S. alone.