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

左心室辅助装置（LVAD）支持允许患有先天性心脏病或 心肌病生长到更大的体重，这是更可行的复杂手术矫正或心脏 移植柏林心脏ExCOR已获得FDA批准用于儿科LVAD应用。虽然这个装置是 在体外，流出移植物仍可能产生冠状动脉/心脏压迫。我们的最终目标是 为新生儿和老年儿科患者开发一种侵入性更小、更可靠的LVAD系统。的 使能技术是双腔插管（DLC），其从心尖插入主动脉。耦合 利用现有的血泵，该DLC从LV抽取血液并将血液输送到主动脉， 的LV。我们的基于DLC的LVAD仅需要一个部位，侵入性较小的心尖插管。其优点是： 1)无流出道移植物和相关的心脏/冠状动脉压迫; 2）无需心肺转流 以及相关的输血; 3）为将来复杂的心脏手术保留更多的侵入性胸骨切开术。这 经心尖至主动脉（TAA）DLC可实现高性能旁路/体外LVAD， 为紫绀型心脏病增加了气体交换器。我们的第一阶段研究证明， 新生儿LVAD系统非常容易通过左胸小切口植入，并有效地卸载LV， 6小时，游离血红蛋白未增加，血红蛋白和血小板计数未降低。二期 SBIR目标：基于第一阶段的结果，我们将优化设计并制造最终的商业产品。 质量TAA DLC原型，用于更小的新生儿应用和5天存活羔羊研究。具体 目标1：设计、制造和台架测试高效率、商业质量的TAA DLC原型 用于较小的新生儿应用和用于5天存活的体内羔羊研究。TAA DLC将由 一体式增强聚氨酯。计算流体动力学将用于优化DLC设计。一 还将开发DLC锚定系统，以将TAA DLC长期固定在心尖和胸壁上 门诊使用。将为2-4 kg新生羔羊急性研究开发13 Fr/10 Fr TAA DLC， Fr TAA DLC将开发用于4周龄羔羊（20 kg）存活研究。最终的原型将进行测试， 性能、可靠性和溶血。将在37%甘油中测试30天耐久性。具体目标2： 在2- 4kg新生羔羊中测试基于DLC的新的13/10 Fr TAA LVAD（n=5）。这项为期6小时的研究旨在 证明TAA DLC适用于临床新生儿LVAD应用。我们将调查TAA部署的难易程度 和体内性能，以及延长输注套管造成的潜在主动脉瓣阻塞。具体 目的3：在4周龄新生羔羊（n=5）中测试TAA DLC原型5天LVAD应用。 4周大的羔羊仍然被认为是一个新生儿，但几乎完全断奶，让我们执行5天 生存研究本体内研究将测试性能、可靠性、耐久性和生物相容性。临到这 SBIR资助完成后，商业化的TAA DLC将提供一种侵入性更低的新生儿LVAD。

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. The Berlin Heart ExCOR, is FDA-approved for pediatric LVAD 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 as well as older pediatric patients. The enabling technology is a double lumen cannula (DLC), which is inserted from the apex into the aorta. Coupled with an existing blood pump, this DLC withdraws blood from the LV and delivers blood into the aorta, unloading the LV. Our DLC-based LVAD only requires a one site, less invasive apex cannulation. The advantages are: 1) no outflow graft and associated heart/coronary artery compression; 2) no need of cardiopulmonary bypass and associated blood transfusion; 3) reserves more invasive sternotomy for future complex heart surgery. This transapical to aorta (TAA) DLC enables a high performance paracorporeal/ extracorporeal LVAD and allows addition of a gas exchanger for cyanotic heart disease. Our Phase I study proved that the TAA DLC-based neonate LVAD system was very easy to implant via a small left thoracotomy and efficiently unloaded the LV for 6 hours with no increase in free hemoglobin and no decrease in hemoglobin and platelet counts. Phase II SBIR objective: Based on the Phase I results, we will optimize the design and fabricate a final commercial quality TAA DLC prototype for even smaller neonate application and for 5 day survival lamb studies. Specific Aim 1: To design, fabricate, and bench-test the high efficiency, commercial quality TAA DLC prototype for smaller neonate application and for 5 day survival in vivo lamb studies. The TAA DLC will be made of one piece reinforced polyurethane. Computational fluid dynamics will be used to optimize the DLC design. A DLC anchoring system will be also developed to secure TAA DLC on apex and chest wall for long-term ambulatory use. A 13 Fr/10 Fr TAA DLC will be developed for 2-4 kg neonate lamb acute study and a 19 Fr/15 Fr TAA DLC will developed for 4 week old lamb (20 kg) survival study. The final prototype will be tested for performance, reliability, and hemolysis. Thirty day durability will be tested in 37% glycerin. Specific Aim 2: To test new 13/10 Fr TAA DLC-based LVAD in 2- 4 kg neonate lamb (n=5). This 6 hour study is designed to prove TAA DLC suitable for clinical neonate LVAD application. We will investigate ease of TAA deployment and in vivo performance, as well as potential aortic valve obstruction by extension infusion cannula. Specific Aim 3: To test the TAA DLC prototype for 5 days LVAD application in 4 weeks old neonate lamb (n=5). The 4 week old lamb is still considered a neonate but almost fully weaned, allowing us to perform 5 day survival study. This in vivo study will test performance, reliability, durability, and biocompatibility. Upon this SBIR grant completion, the commercialized TAA DLC will provide a less invasive neonate LVAD.