Development of Double Lumen Cannula for Percutaneous Right Heart Support

描述(申请人提供)：左心室辅助装置(LVAD)越来越多地应用于治疗晚期心力衰竭，显示出发病率/死亡率和生活质量的改善。右心衰竭(RHF)影响多达40%的LVAD患者，并显著增加他们的发病率和死亡率。其中三分之一需要右室辅助装置(RVAD)，需要第二次开胸安装，第三次需要取出。为了避免这两个大手术，需要进行经皮RVAD(PRVAD)。目前基于TandemHeartTM插管的pRVAD需要两个主要静脉插管和一个高阻力的长回路，导致患者行动受限，影响RVAD性能的血流。我们的最终目标是开发一种单部位经皮RVAD(PRVAD)系统，实现完全的右心支持，避免额外的两次开胸手术。这项技术将是一种经皮双腔导管(DLC)，它将从右心房(RA)引流静脉血液，并将血液直接注入肺动脉(PA)。我们在第一阶段SBIR的目标是开发和制造用于pRVAD的DLC组件的工作原型，并在成年绵羊身上测试原型的性能。我们假设，预弯的DLC，加上任何商业上可用的血泵，可以很容易地部署在右心和PA中，用于经皮全右心支持，逆转RHF。具体目标将是开发一种用于RVAD/OxyRVAD的DLC组件，并测试我们的原型pRVAD DLC用于经皮部署和6h体内性能。在这份SBIR I提案中，我们将设计和制造一个经皮DLC的工作原型来辅助RHF，并设计和制造一个气囊引导导入器的工作原型来促进DLC的部署。DLC由DLC主体延长型输液插管组成。引流腔在RA开口，以引流SVC和IVC的全部静脉回流，而输液套管从主要的DLC膜套输液管腔延伸出来。台架测试测量将包括导入器在输液管腔/延伸输液套管内的适合性以及体外DLC流动动态性能。绵羊体内实验(n=5)旨在测试DLC组件的经皮插入、推进和展开，以及体内血流动力学性能。在这项SBIR赠款完成后，商业化的DLC将为RHF患者提供pRVAD。这种微创技术将降低RVAD的应用门槛，并通过降低RHF相关死亡率和活动能力，对LVAD在晚期心力衰竭中的应用产生重大影响。PRVAD也可应用于其他RHF患者，继发于肺动脉高压、右心梗死所致致癌性休克和心脏手术后。此外，在电路中添加人工肺将在合并RHF和肺衰竭时将pRVAD转换为OxyRVAD。如此广泛的应用将使世界各地的患者受益，也将有利于美国经济。 公共卫生意义：我们建议开发一种用于经皮右室辅助装置的双腔插管，将危重右心衰竭患者与康复、移植和高级治疗联系起来。

DESCRIPTION (provided by applicant): Left ventricular assist devices (LVADs) are increasingly applied to treat advanced heart failure, demonstrating improvement of morbidity/mortality and quality of life. Right heart failure (RHF) affects up to 40% of LVAD patients and significantly contributes to their morbidity and mortality. One third of them require right ventricular assist device (RVAD) which needs a second open chest procedure for installation and a third one for its removal. A percutaneous RVAD (pRVAD) is required to eliminate these two major surgeries. The current TandemHeartTM Cannula-based pRVAD requires two major venous cannulations and a high resistance long circuit, resulting in restricted patient mobility and compromised blood flow affecting RVAD performance. Our ultimate goal is to develop a single-site percutaneous RVAD (pRVAD) system that achieves full right heart support, avoiding two additional open chest surgeries. The enabling technology will be a percutaneous double lumen cannula (DLC) that will drain venous blood from the right atrium (RA) and infuse blood directly into the pulmonary artery (PA). Our objective in this Phase I SBIR is to develop and fabricate a working prototype of a DLC assembly for pRVAD and to test prototype performance in adult sheep. We hypothesize that the pre-curved DLC, coupled with any commercially available blood pump, can be easily deployed in the right heart and the PA for percutaneous total right heart support, reversing RHF. The Specific Aim will be to develop a DLC Assembly for RVAD/OxyRVAD and to test our prototype pRVAD DLC for percutaneous deployment and 6h in vivo performance. In this SBIR I proposal, we will design and fabricate a working prototype of a percutaneous DLC to assist RHF and design and fabricate a working prototype of the balloon guided introducer to facilitate DLC deployment. The DLC consists of main DLC body extension infusion cannula. The drainage lumen opens in the RA to drain total venous return from both the SVC and IVC, while the infusion cannula extends from the main DLC membrane sleeve infusion lumen. The bench test measurements will include how well the introducer fits inside the infusion lumen/extension infusion cannula and in vitro DLC flow dynamic performance. The in vivo sheep experiments (n=5) are designed to test the DLC assembly for percutaneous insertion, advancement and deployment, and for in vivo hemodynamic performance. Upon this SBIR grant completion, the commercialized DLC will provide pRVAD to RHF patients. This minimally invasive technology will lower the threshold of RVAD application and have significant impact on LVAD application in advanced heart failure by decreasing RHF associated mortality and mobility. pRVAD can also be applied to other RHF patients, secondary to pulmonary hypertension, right heart infarction induced carcinogenic shock, and postcardiotomy. Furthermore addition of an artificial lung to the circuit will convert pRVAD to OxyRVAD for combined RHF and lung failure. Such wide application will benefit patients around the world, as well as the American economy. PUBLIC HEALTH RELEVANCE: We are proposing to develop a double lumen cannula for percutaneous right ventricular assist device to bridge critical right heart failure patient to recovery, transplantation and advance treatment.