Anastomotic Device for Large Vascular Grafts

描述(由申请人提供)：该计划的目标是基于一种新的吻合器设计，开发一种用于大血管和血管移植物的通用吻合器。该装置的使用可以提供当前手动缝合方法的替代方法，具有产生更好和更可重复性的吻合口的潜力，并且具有减少交叉夹闭或旁路时间的要求。这种设备的直接应用是在移植物/插管与主动脉之间进行端到侧吻合，例如，作为VAD的流出管道。根据该计划的第一阶段，将通过体外和急性体内研究来设计、制造和表征可行性原型。在我们第一阶段研究取得成功的基础上，该计划的第二阶段将专注于开发具有集成功能的工具，进行生物兼容性的长期体内研究，以及为便于使用和制造而进行设计优化。公共卫生相关性：该吻合器将提高大血管吻合的质量，并减少手术时间要求。有许多外科应用可以受益于一种快速且可重复的方法来放置大的(即直径大于5 mm的)合成血管移植物，尤其是一种降低出血并发症发生率的方法。这些措施包括植入脑室辅助装置(VAD)、放置动静脉瘘以进行肾透析、主动脉弓重建和腹主动脉瘤(AAA)修补术。仅在美国，这种血管吻合器每年就可适用于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.