Development of TransApical to Aorta Double Lumen Cannula for a Neonate LVAD

用于新生儿 LVAD 的经心尖至主动脉双腔插管的开发

基本信息

批准号：
8712075
负责人：
Stephen R Topaz
金额：
$ 14.88万
依托单位：
W-Z BIOTECH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-04-01 至 2015-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8712075
关键词：
Acute Adult American Animal Testing Anticoagulation Aorta Applications Grants Area Berlin Biomedical Engineering Blood Body Weight Businesses Cannulas Cannulations Carbon Dioxide Cardiac Cardiac Surgery procedures Cardiogenic Shock Cardiomyopathies Cardiopulmonary Bypass Chest Childhood Complex Coronary artery Coupled Deposition Development Devices Drainage procedure Excision FDA approved Fibrin Gases Goals Grant Heart Heart Diseases Heart Transplantation Heart failure Hemoglobin Infusion procedures Kentucky Laboratory Animal Production and Facilities Left Life Liquid substance Lung Measurement Measures Membrane Morbidity - disease rate Neonatal Operative Surgical Procedures Patients Performance Phase Plasma Platelet Activation Play Polyurethanes Pump Recovery Resistance Respiratory Diaphragm Sheep Small Business Innovation Research Grant Stainless Steel Sternotomy Surgeon System Technology Test Result Testing Thoracotomy Thrombelastography Transplantation Universities Ventricular Work aortic valve artificial lung ascending aorta base blood pump congenital heart disorder design experience flexibility improved in vivo mortality multidisciplinary neonate novel prevent prototype public health relevance research and development research study respiratory total artificial heart ventricular assist device

项目摘要

DESCRIPTION (provided by applicant): Left ventricular assist device (LVAD) support allows the neonate with congenital heart disease or cardiomyopathy to grow to a larger body weight that is more feasible for complex surgical correction or heart transplant. A paracorporeal LVAD, the Berlin heart ExCor, is FDA-approved for pediatric application. Although this device is outside the body, the outflow graft may still create coronary artery/heart compression. Our ultimate goal is to develop a less invasive and dependable LVAD system for the neonate. The enabling technology will be a small (16-18 Fr) double lumen cannula (DLC), which is inserted from the apex though the LV and aortic valve into the aorta with the drainage lumen opening in the LV and the infusion lumen in the aorta. Coupled with a blood pump, blood is withdrawn from the LV and infused into the aorta to unload the LV though a single cannulation. This DLC-based LVAD: 1) has only one apex cannulation, avoiding heart/coronary artery compression, 2) has a much smaller apex cannulation, eliminating cardiopulmonary bypass, 3) requires a less traumatic left thoracotomy, replacing traumatic medium sternotomy, and 4) has a flexible configuration, allowing a bigger paracorporeal pump for stronger performance and the addition of a gas exchanger for cyanotic heart diseases. Our DLC-based LVAD is much simpler, less invasive, more powerful, and very suitable for neonate application. Our objective in this Phase I SBIR is to develop and fabricate a working prototype of a DLC assembly for a neonate LVAD and to test the prototype's performance in neonate sheep. Our hypothesis is that this new DLC, coupled with a commercial blood pump, will provide total LV support and save the life of sick neonate. It will bridge the patient to recovery, transplant, or further advanced heart surgery. Specific Aim 1: To develop a new TransApical to Aorta (TAA) DLC assembly. A. To design and fabricate a new working prototype of a TAA DLC for a neonate LVAD. The DLC main body outer wall will be constructed with wire reinforced polyurethane. The inner infusion lumen will use an eccentric membrane sleeve. The DLC membrane sleeve infusion lumen extends out of DLC main body to the extension infusion cannula (EIC). The EIC will be reinforced by stainless steel wires across the aortic valve into the ascending aorta. A sewing plate will be designed for sewing the DLC onto the apex, preventing TAA DLC dislodgement. B. Bench testing of the TAA DLC assembly. Bench testing will be done in an ex vivo circuit to measure DLC flow performance. Specific Aim 2: To test our prototype TAA DLC for ease of deployment and 6 hr. in vivo performance. The TAA DLC prototype will be coupled with a CentriMag pump to form a TAA LVAD system. The in vivo new born lamb experiments (n=5) will test the DLC for TAA deployment and in vivo performance. The 16 Fr DLC- based TAA LVAD will pump the blood at a flow rate up to 1 L/min against 200 mmHg ?P. Animal testing results will be used to optimize the TAA DLC design for best performance/reliability for the Phase II grant. Upon this SBIR grant completion, the commercialized TAA DLC will provide a less invasive neonate LVAD.

描述（由申请人提供）：左心室辅助装置（LVAD）的支撑允许新生儿患有先天性心脏病或心肌病，可以增长到更大的体重，这对于复杂的手术矫正或心脏移植更可行。柏林心脏的excor parac体体LVAD已通过FDA批准用于儿科应用。尽管该设备不在体内，但流出移植物仍可能会产生冠状动脉/心脏压缩。我们的最终目标是为新生儿开发一个侵入性和可靠的LVAD系统。支持技术将是一个小的（16-18 FR）双管制套管（DLC），该套管通过LV和主动脉瓣从顶点插入主动脉，其中LV中的排水管道开口和主动脉中的输注管道。再加上血泵，从LV中取出血液，并注入主动脉中以通过单个插管卸载LV。这款基于DLC的LVAD：1）只有一个顶端插管，避免心脏/冠状动脉压缩，2）具有较小的Apex插管，消除了心肺旁路，3）需要一个较小的左胸腔手术，需要更大的型胸骨胸骨静脉内部的外伤，4）具有较大的配置，使其具有柔韧性的速度，并且具有柔韧性的速度，并且具有柔韧性的速度，并且具有柔韧性的速度，并且具有弹性的速度，并且具有较大的配置。心脏病。我们的基于DLC的LVAD更简单，侵入性更低，更强大，非常适合新生儿应用。我们在此阶段I SBIR的目标是为新生儿LVAD开发和制造DLC组件的工作原型，并测试该原型在新生儿绵羊中的性能。我们的假设是，这种新的DLC再加上商业血液泵，将提供全部的LV支持并挽救病态的新生儿的生命。它将弥合患者以康复，移植或进一步的心脏手术。具体目标1：开发新的转换为主动脉（TAA）DLC组件。答：为新生儿LVAD设计和制造TAA DLC的新工作原型。 DLC主体外壁将用线加固的聚氨酯构建。内部输注管道将使用偏心膜套筒。 DLC膜套筒输注管道从DLC主体延伸至延伸输注套管（EIC）。 EIC将通过横跨主动脉瓣的不锈钢线加强到升主动脉。缝纫板将设计用于将DLC缝在顶点上，以防止TAA DLC脱位。 B. TAA DLC组件的台式测试。台式测试将在离体电路中进行，以测量DLC流量性能。特定目标2：测试我们的原型TAA DLC，以便于部署和6小时。体内性能。 TAA DLC原型将与Centrimag泵耦合，形成TAA LVAD系统。体内新出生的羔羊实验（n = 5）将测试DLC的TAA部署和体内性能。 16个基于DLC的FR TAA LVAD将以高达1 L/min的流速为200 mmHg？p泵送血液。动物测试结果将用于优化TAA DLC设计，以获得II期赠款的最佳性能/可靠性。在完成SBIR赠款完成后，商业化的TAA DLC将提供侵入性的新生儿LVAD。