Development of Double Lumen Cannula for Percutaneous Right Heart Support

经皮右心支持双腔插管的研制

• 批准号: 8314246
• 负责人: Bill Sidor
• 金额: $ 15.58万
• 依托单位: W-Z BIOTECH, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-05 至 2014-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314246
• 关键词: Adult; Affect; Alloys; American; Animal Testing; Applications Grants; Area; Biomedical Engineering; Blood; Blood flow; Businesses; Cannulas; Cannulations; Carbon Dioxide; Cardiac; Cardiopulmonary; Catheters; Chest; Complex; Coupled; Development; Device or Instrument Development; Devices; Distal; Drainage procedure; Excision; Failure; Gases; Goals; Grant; Heart; Heart failure; In Vitro; Infusion procedures; Kentucky; Label; Laboratory Animal Production and Facilities; Left; Liquid substance; Lung; Measurement; Medical Device; Membrane; Memory; Monitor; Morbidity - disease rate; Myocardial Infarction; Operative Surgical Procedures; Outcome; Patients; Performance; Phase; Polyurethanes; Positioning Attribute; Procedures; Publications; Pulmonary Hypertension; Pulmonary artery structure; Pulmonary valve structure; Pump; Quality of life; Recovery; Research Support; Resistance; Right atrial structure; Secondary to; Shapes; Sheep; Shock; Site; Small Business Innovation Research Grant; Stainless Steel; Surgeon; System; Technology; Testing; Thoracic Surgical Procedures; Transplantation; Universities; Venous; Work; artificial lung; base; blood pump; commercialization; design; experience; hemodynamics; improved; in vivo; minimally invasive; mortality; multidisciplinary; pressure; prototype; research and development; research study; respiratory; ventricular assist device

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.

描述（由申请人提供）：左心室辅助装置（LVAD）越来越多地用于治疗晚期心力衰竭，证明了发病率/死亡率和生活质量的改善。右心衰竭（RHF）影响高达40%的LVAD患者，并显著增加其发病率和死亡率。其中三分之一需要右心室辅助装置（RVAD），需要第二次开胸手术进行安装，第三次进行移除。需要经皮RVAD（pRVAD）来消除这两种大手术。目前的TandemHeartTM基于套管的pRVAD需要两个主要静脉插管和一个高阻力长回路，导致患者活动受限和血流受损，影响RVAD性能。 我们的最终目标是开发一种单部位经皮RVAD（pRVAD）系统，实现完全右心支持，避免两次额外的开胸手术。使能技术将是一种经皮双腔插管（DLC），它将从右心房（RA）排出静脉血，并将血液直接注入肺动脉（PA）。我们在第I阶段SBIR的目标是开发和制造用于pRVAD的DLC组件的工作原型，并在成年绵羊中测试原型性能。我们假设，预弯DLC与任何市售血泵配合使用，可以轻松地在右心和PA中展开，用于经皮全右心支持，逆转RHF。 具体目标是开发RVAD/OxyRVAD的DLC组件，并测试我们的原型pRVAD DLC的经皮展开和6小时体内性能。在本SBIR I提案中，我们将设计和制造经皮DLC的工作原型以辅助RHF，并设计和制造球囊引导导引器的工作原型以促进DLC展开。DLC由主体延长件输注套管组成。引流腔在RA中打开，以从SVC和IVC引流总静脉回流，而输注套管从主DLC膜套管输注腔延伸。台架试验测量值将包括导入器在输注腔/延长输注套管内的匹配程度和体外DLC流动动力学性能。绵羊体内实验（n=5）旨在测试DLC组装件的经皮插入、推进和展开以及体内血流动力学性能。在SBIR授权完成后，商业化DLC将向RHF患者提供pRVAD。这种微创技术将降低RVAD应用的阈值，并通过降低RHF相关的死亡率和活动性，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、右心梗死诱发的致癌性休克和心切开术后。此外，在回路中添加人工肺将使pRVAD转换为OxyRVAD，用于合并RHF和肺衰竭。这种广泛的应用将使世界各地的患者以及美国经济受益。 公共卫生关系：我们建议开发一种用于经皮右心室辅助装置的双腔套管，以桥接危重右心衰竭患者的康复、移植和进一步治疗。

项目成果

Percutaneous Double Lumen Cannula for Right Ventricle Assist Device System: A Computational Fluid Dynamics Study.

• DOI: 10.1016/j.bbe.2016.04.002
• 发表时间: 2016
• 期刊: Biocybernetics and biomedical engineering
• 影响因子: 6.4
• 作者: Condemi F;Wang D;Fragomeni G;Yang F;Zhao G;Jones C;Ballard-Croft C;Zwischenberger JB
• 通讯作者: Zwischenberger JB