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）：根据新型的订书机设计，该提议的程序的目的是为大容器和血管移植物开发一种通用吻合装置。该设备的使用可以为当前的手动缝合方法提供替代过程，并具有产生吻合术的潜力，具有更好，更可重现的性能，并减少了跨夹具或旁路时间要求。该设备的立即应用是在移植/套管和主动脉之间进行端到一侧的吻合，例如，作为VAD的流出导管。在该程序的第一阶段，将通过体内和体内急性研究设计，制造和表征可行性原型。基于我们的第一阶段研究的成功，该计划的第二阶段将着重于开发具有集成功能的工具，生物相容性的慢性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：Stapler将提高大型血管吻合的质量并减少工作时间要求。有许多手术应用可以从快速且可重复的方法中受益，即放置大型（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。其中包括心室辅助装置（VAD）植入，肾脏透析，主动脉弓重建和腹部主动脉瘤（AAA）修复的动脉（AV）瘘管的位置。仅在美国，该血管订书机可能每年适用于每年100,000个程序。