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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）支持使患有先天性心脏病或心肌病的新生儿生长到更大的体重，这对于复杂的外科手术矫正或心脏移植更可行。一种旁心室辅助装置，即柏林心脏ExCor，经FDA批准可用于儿科应用。尽管该器械在体外，流出道移植物仍可能造成冠状动脉/心脏压迫。我们的最终目标是为新生儿开发一种侵入性小、可靠的LVAD系统。启用技术将是小型（16-18 Fr）双腔插管（DLC），从心尖通过LV和主动脉瓣插入主动脉，引流腔在LV中打开，输注腔在主动脉中。与血泵结合，血液从LV抽出并注入主动脉，以通过单个插管卸载LV。这种基于DLC的LVAD：1）只有一个心尖插管，避免心脏/冠状动脉压迫，2）心尖插管小得多，消除了心肺转流，3）需要较少的创伤性左胸廓切开术，取代创伤性中等胸骨切开术，以及4）具有灵活的配置，允许更大的旁路泵以获得更强的性能，并增加了用于紫绀心脏病的气体交换器。我们的基于DLC的LVAD更简单，侵入性更小，功能更强大，非常适合新生儿应用。我们在第一阶段SBIR中的目标是开发和制造用于新生儿LVAD的DLC组件的工作原型，并在新生儿绵羊中测试原型的性能。我们的假设是，这种新的DLC，加上商业血泵，将提供总左心室支持和挽救生命的新生儿生病。它将为患者的康复、移植或进一步的心脏手术架起桥梁。具体目标1：开发一种新的经心尖至主动脉（TAA）DLC组装件。A.设计并制造了一种新的用于新生儿LVAD的TAA DLC工作原型。DLC主体外壁将由钢丝增强聚氨酯制成。内输注腔将使用偏心膜套管。DLC膜套管输注腔从DLC主体延伸至延长输注套管（EIC）。EIC将通过不锈钢丝穿过主动脉瓣进入升主动脉进行加固。将设计一个缝合板，用于将DLC缝合到心尖上，防止TAA DLC移位。B。TAA DLC组件的台架试验。将在离体回路中进行台架测试，以测量DLC流量性能。具体目标2：测试我们的原型TAA DLC的易展开性和6小时体内性能。TAA DLC原型将与CentriMag泵耦合，以形成TAA LVAD系统。体内新生羔羊实验（n=5）将测试DLC的TAA展开和体内性能。基于DLC的16 Fr TAA LVAD将在200 mmHg压力下以高达1 L/min的流速泵送血液？P.动物试验结果将用于优化TAA DLC设计，以获得II期资助的最佳性能/可靠性。在SBIR授权完成后，商业化的TAA DLC将提供一种微创新生儿LVAD。