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

在美国，心力衰竭(HF)每年占死亡人数的四分之一，使其成为主要的死亡原因 心力衰竭患者人数超过650万人。由于供体心脏的稀缺，左心室辅助 心脏移植装置(LVAD)已被临床接受为心脏移植的替代治疗选择 由于它们的耐用性和长期生存能力。提高存活率和降低死亡率是相关的 采用侵入性较小的非体外循环方法。目前临床批准的LVAD需要部分阻断主动脉 以促进流出的移植物吻合术，也可能需要交叉夹闭主动脉和心肺 术中行体外循环(CPB)。为了改善临床结果，Mast LLC(肯塔基州路易斯维尔) 开发一种双气囊部分闭塞装置(心脏动作)，旨在提供安全、可靠和 有效的止血场，可以在不需要外部血管的情况下吻合左冠状动脉流出段移植物 夹紧。心脏活动系统在内部阻断升主动脉(夹闭)，产生止血作用 可以放置吻合口的口袋，同时仍允许血管灌注(最高可达5 L/分钟流量，&lt；5 毫米汞)，无血管组织损伤。心脏活动是一种基于导管的系统，由球囊支架组成 结构、多腔导管和输送护套。球囊-支架结构，由两个 聚亚安酯，环形气球，放置在编织聚酯覆盖的自膨胀和 可折叠支架，将提供主动脉闭塞，使通过设备管腔的灌流。气球 气球被充气，直到达到足够的管壁接触，在气球之间形成静态环境。 多腔导管和输送护套将有助于装置的放置、部署和收回。这个 建议的工具将是一种侵入性较小的18Fr护套导管解决方案。支架覆盖物提供了一个中心 管腔用于灌流，消除了与完全血管闭塞相关的风险。充气的气球提供了 血管内闭塞，维持自然的血管结构，从而创造一个静态环境， 将为外科医生提供在血管上进行手术的无泄漏区域，同时也减少了 组织损伤。在这份SBIR第一阶段提案中，我们将论证心脏动作系统的可行性，以及 然后计划提交第二阶段提案，以完成工程开发，实现设计冻结 心脏动作系统和完整的临床前测试，以证明有效性、安全性和可靠性。这一阶段 II实验数据将用于支持食品的调查设备豁免(IDE)申请 和药品管理局(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.