Development of a Partial Occlusion Device to Aid in Coring and Anastomsis of the Aorta

心力衰竭（HF）占美国每年死亡人数的四分之一，使其成为死亡的主要原因， HF患者人数超过650万人。由于供体心脏稀缺，左心室辅助 作为心脏移植的替代治疗选择， 由于其耐用性和长期可行性。生存率的提高和死亡率的降低 采用微创和非体外循环方法。目前临床批准的LVAD需要主动脉部分阻断 以便于流出道移植物吻合，并且还可能需要交叉夹紧主动脉和心肺 LVAD植入期间的体外循环（CPB）。为了改善临床结果，MAST LLC（路易斯维尔，肯塔基州） 开发一种双球囊部分闭塞装置（CardiAction），旨在提供一种安全，可靠， 有效的止血区域，允许LVAD流出道移植物的吻合，而无需外部 夹紧。CardiAction系统在内部闭塞升主动脉（夹闭），形成止血 可放置吻合口的囊袋，同时仍允许血管灌注（高达5 L/min流量，< 5 mmHg），无血管组织损伤。CardiAction是一种基于导管的系统，由球囊支架组成 结构、多腔导管和输送鞘。球囊支架结构由两个 聚氨酯，环形球囊位于编织聚酯覆盖的自膨胀球囊的端部， 可折叠支架将提供主动脉闭塞，使得能够通过器械管腔进行灌注。气球 膨胀直到实现充分的血管壁接触，在球囊之间产生静态环境。 多腔导管和输送鞘将辅助器械放置、展开和回撤。的 申报工具将是一种基于18 Fr鞘管导管的微创解决方案。支架覆膜提供了一个中心 用于灌注的管腔，消除了与完全血管闭塞相关的风险。膨胀的气球提供 血管内闭塞，其维持天然血管结构，从而产生静态环境， 将为外科医生提供无泄漏区域以在血管上进行手术，同时还降低 组织损伤在SBIR第一阶段提案中，我们将证明CardiAction系统的可行性， 然后计划提交第二阶段的建议，以完成工程开发，以实现设计冻结， CardiAction系统和完整的临床前测试，以证明有效性、安全性和可靠性。相位 II实验数据将用于支持对食品的研究器械豁免（IDE）申请 和药物管理局（FDA）进行临床试验。

Heart failure (HF) accounts for 1 in 4 deaths in the US each year, making it the leading cause of death with a HF patient population of over 6.5 million people. Due to a scarcity of donor hearts, left ventricular assist devices (LVADs) have gained clinical acceptance as an alternative treatment option to heart transplantation due to their durability and long-term viability. Improved survival and reduced mortality have been associated with less invasive and off-pump approaches. Current clinically-approved LVADs require aortic partial clamping to facilitate outflow graft anastomosis and may also require cross-clamping of the aorta and cardiopulmonary bypass (CPB) during LVAD implantation. To improve clinical outcomes, MAST LLC (Louisville, KY) is developing a two-balloon partial occlusion device (CardiAction) designed to provide a safe, reliable, and effective hemostatic field that allows for the anastomosis of an LVAD outflow graft without the need for external clamping. The CardiAction system internally occludes the ascending aorta (clamping), creating a hemostatic pocket for which an anastomosis can be placed, while still allowing vessel perfusion (up to 5 L/min flow, < 5 mmHg) without vessel tissue damage. CardiAction is a catheter-based system comprised of a balloon-stent structure, multi-lumen conduit, and a delivery sheath. The balloon-stent structure, which consists of two polyurethane, toroidal balloons positioned on the ends of a woven-polyester covered self-expanding and collapsible stent, will provide aortic occlusion enabling the perfusion through the device lumen. The balloons are inflated until sufficient vessel wall contact is achieved, creating a static environment between the balloons. The multi-lumen conduit and delivery sheath will assist in device placement, deployment, and retraction. The proposed tool will be a less invasive 18Fr sheath catheter-based solution. The stent cover provides a central lumen for perfusion, eliminating risks associated with complete vessel occlusion. The inflated balloons provide intravascular occlusion that maintains the natural vascular structure, thereby creating a static environment that will provide the surgeon with a leak-free area to operate on the vessel while also reducing the potential for tissue damage. In this SBIR phase I proposal, we will demonstrate feasibility of the CardiAction system, and then plan to submit a phase II proposal to complete engineering development to achieve a design freeze of the CardiAction system and complete pre-clinical testing to demonstrate efficacy, safety, and reliability. The phase II experimental data will be used to support an Investigational Device Exemption (IDE) application to the Food and Drug Administration (FDA) for clinical trials.