Development of an Implantable "Plug and Play" TransApical to Aorta VAD

开发可植入式“即插即用”经心尖主动脉 VAD

基本信息

批准号：
7272136
负责人：
Stephen R. Topaz
金额：
$ 19.01万
依托单位：
S P TECH
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-15 至 2009-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7272136
关键词：
Acute Acute myocardial infarction Address Adult Anastomosis - action Animal Model Animal Testing Animals Anterior Aorta Apex of the Heart Artificial Heart Back Biological Neural Networks Blood Blood Circulation Blood Pressure Blood Vessels Bypass Caliber Cannulas Cardiac Cardiac Surgery procedures Cardiogenic Shock Cardiopulmonary Bypass Cardiovascular system Catheters Cause of Death Cessation of life Characteristics Chronic Cicatrix Clinical Coagulation Process Complex Computers Condition Coupled Databases Destinations Development Device Designs Device or Instrument Development Devices End Point Endosome Proton Evaluation Event Failure Figs - dietary Friction Functional disorder Generations Germany Goals Harvest Head Heart Heart Transplantation Heart failure Heart-Assist Devices Heart-Lung Machine Heparin Hour Implant Injury Intra-Aortic Balloon Pumping Intraventricular Kinetics Left Left ventricular structure Legal patent Length Longitudinal Studies Lysosome Proton Measures Mechanics Medical Metals Methods Mitral Valve Modeling Modification Monitor Motor Myocardial Myocardial Infarction Myocardial Ischemia Needles Operative Surgical Procedures Organ Organ failure Outcome Study Output Partner in relationship Patients Pattern Performance Perfusion Peripheral Pharmaceutical Preparations Phase Placement Play Preclinical Testing Prevention Procedures Production Proton Pump Pulsatile Flow Pump Randomized Recovery Reperfusion Injury Reporting Residual state Resistance Resolution Respiratory Diaphragm Rest Risk Saline Secondary to Secure Series Sheep Shock Speed Stab Wounds Stress Stroke Structure System Technology Testing Texas Thoracotomy Thrombosis Thrombus Time Transesophageal Echocardiography Transplantation Trauma Treatment Protocols United States Food and Drug Administration United States National Institutes of Health Universities Validation Ventricular Weaning Work aortic valve ascending aorta base blood pump concept cytokine day design expectation hemodynamics implantation improved in vivo mechanical drive migration mortality novel performance tests pre-clinical pressure prevent prospective prototype purge reconstruction repaired response seal shear stress size success ventricular assist device voltage

项目摘要

DESCRIPTION (provided by applicant): Postcardiotomy shock (failure to wean from bypass) remains a highly morbid event. Roughly 60% of patients will wean from a short-term (mean 5 days) left ventricular assist device (LVAD), but only half of these patients will survive to discharge. Likewise, Cardiogenic Shock (CS) is a serious clinical condition responsible for a majority of early deaths from acute myocardial infarction (AMI) with 50% 30-day and 80-90% overall mortality. All current LVADs used to treat post-cardiotomy shock use a blood return graft (or cannula) to the aorta and a large cannula (>16 mm outer diameter) through the cardiac apex. Our goal is to develop a Plug and Play (P&P) TransApical to Aorta VAD pump that is simple and easily inserted within a few minutes with flows up to 10 L/min against 100 mmHg afterload for up to 3 months reliable performance. By immediately reducing left ventricle (LV) wall stress and distension and by preventing LV enlargement our P&P TransApical to Aorta VAD pump will serve as either a bridge to transplant or recovery from cardiogenic shock. Our specific aims are to: 1) Fabricate a prototype design that includes efficient, thrombus free heparin saline purged needle roller bearings, which decreases bearing friction, increases durability, improves pump efficiency, and prevents thrombosis generation. Other modifications include blood path enlargement and shortening to decrease resistance and increase pulsatility, and the addition of a formed metal disk to facilitate surgical attachment. 2) Perform bench testing for performance and durability at different RPM's. We anticipate a pump flow of 10 L/min @ 17,500 RPM against a 100 mmHg afterload with a pump controller accuracy of 5%. A mock loop durability test for 3 months will assess failure or wear. 3) Perform large animal studies of our new prototype P&P TransApical to Aorta VAD: One-day studies in healthy sheep (n=10) will determine the amount of LV assistance achievable by a P&P TransApical to Aorta VAD and will demonstrate the interaction of the pump with intraventricular structures such as the anterior leaflet of the mitral valve and sub valvular structures. This performance testing will direct any further prototype modifications. Utilizing the final P&P TransApical to Aorta VAD prototype design coupled with the newly designed portable pump control system, we will then test the feasibility of the system design as a chronic ambulatory device in healthy sheep (n=3) for 5 days. Successful completion of Phase I will allow further refinement for long-term animal testing in Phase II, leading to pre-clinical testing in a large animal injury model. Catastrophic heart failure is a leading cause of death in patients following heart surgery and in some patients following a heart attack. We have designed, developed and will build a working "plug and play" pump (the size of a ballpoint pen) that is inserted directly into the failing heart within minutes to provide total support of the circulation. This unique design will allow immediate heart support for up to 3 months to allow the heart to recover or serve as a bridge to transplantation. Our simple, easily inserted pump will revolutionize the field of mechanical heart assist.

描述（由申请人提供）：明显的后切开术（未能从旁路中解除）仍然是一个病态的事件。大约60％的患者将从短期（平均5天）左心室辅助装置（LVAD）中脱颖而出，但只有一半的患者能够生存为出院。同样，心源性休克（CS）是一种严重的临床状况，导致大多数因急性心肌梗塞（AMI）的早期死亡（50％30天和80-90％的总死亡率）。所有用于治疗心脏切开术休克的当前LVAD都通过心脏顶点对主动脉的血液回移（或套管）和大型套管（> 16毫米的外径）。我们的目标是开发一个插头（P＆P）到主动脉VAD泵的插头（P＆P），该泵在几分钟内简单易于插入，流动最多为10 l/min，而100 mmhg的后负载可靠3个月可靠的性能。通过立即减少左心室（LV）壁应力和延伸，并防止LV扩大我们的P＆P Transapical至主动脉VAD泵，将作为移植桥或从心源性休克中恢复的桥梁。我们的具体目的是：1）制造一种原型设计，其中包括有效的，无血栓的肝素盐水清除的针辊轴承，从而降低轴承摩擦，提高耐用性，提高泵的效率并防止血栓形成产生。其他修饰包括血路扩大和缩短以降低抗药性并增加脉动性，以及添加形成的金属盘以促进手术附着。 2）在不同的rpm处进行性能和耐用性的基准测试。我们预计，泵流量为10 l/min @ 17,500 rpm，而泵控制器精度为5％，为100 mmHg的后负载。模拟环耐用性测试3个月将评估故障或磨损。 3）对我们的新原型p＆p进行大规模动物研究至主动脉VAD：健康绵羊的一日研究（n = 10）将确定由p＆p transapical to to aorta vad可获得的LV辅助量，并将证明泵与泵室内的泵的相互作用，例如，泵的静脉内结构，例如静脉内部的小叶，例如细瓣膜结构。该性能测试将指导任何进一步的原型修改。利用最终的P＆P Transapical至主动脉VAD原型设计，再加上新设计的便携式泵控制系统，我们将测试系统设计作为健康绵羊（n = 3）的慢性门诊装置的可行性5天。成功完成I期，将在II期中进行长期动物测试的进一步完善，从而在大型动物损伤模型中进行临床前测试。灾难性心力衰竭是心脏手术后患者和某些心脏病发作后患者的主要死亡原因。我们已经设计，开发并将建立一个有效的“插头”泵（圆珠笔的大小），该泵将在几分钟内直接插入失败的心脏，以提供循环的全部支持。这种独特的设计将允许最多3个月的心脏支撑，以使心脏恢复或充当移植的桥梁。我们简单，易于插入的泵将彻底改变机械心脏辅助的领域。