Anastomotic Device for Large Vascular Grafts

大型血管移植物吻合装置

• 批准号: 7671280
• 负责人: HONG ZHANG
• 金额: $ 9.97万
• 依托单位: ABIOMED, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-01 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7671280
• 关键词: Abdominal Aortic Aneurysm; Acute; Address; Anastomosis - action; Aorta; Arteriovenous fistula; Blood; Blood Vessels; Bypass; Caliber; Cannulas; Chronic; Clinical; Coronary Artery Bypass; Development; Devices; Equilibrium; Excision; Family suidae; Head; Hemorrhage; Manuals; Mechanics; Methods; Modeling; Operative Surgical Procedures; Penetration; Performance; Phase; Phase I Clinical Trials; Physiological; Positioning Attribute; Procedures; Process; Renal dialysis; Resistance; Saline; Saphenous Vein; Shapes; Side; Slide; Structure; Surgical sutures; System; Techniques; Technology; Testing; Time; Tissues; Vascular Graft; aortic arch; ascending aorta; base; biomaterial compatibility; commercialization; dacron; design; implantation; improved; in vivo; innovation; instrument; nitinol; novel; pressure; programs; prototype; public health relevance; reconstruction; repaired; restenosis; success; tool; ventricular assist device

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.

描述（由申请人提供）：本申报项目旨在基于新型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械。该装置的使用可以提供当前手动止血方法的替代程序，具有产生具有更好和更可再现性能的止血的潜力，并且具有减少的交叉夹紧或旁路时间要求。该装置的直接应用是在移植物/插管和主动脉之间进行端侧吻合，例如，作为VAD的流出管道。在该项目的第一阶段，将通过体外和急性体内研究设计、制造和表征可行性原型。基于我们第一阶段研究的成功，该项目的第二阶段将专注于开发具有集成功能的工具、生物相容性的长期体内研究以及易于使用和制造的设计优化。公共卫生相关性：吻合器将改善大血管病变的质量，并减少手术时间要求。有许多外科应用可以受益于放置大的（即大于5 mm直径）合成血管移植物的快速和可重复的方法，特别是降低出血并发症发生率的方法。这些包括心室辅助装置（VAD）植入、肾透析的动静脉（AV）瘘放置、主动脉弓重建和腹主动脉瘤（AAA）修复。仅在美国，该血管吻合器每年可用于100，000例手术。