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

描述（由申请人提供）：左心室辅助装置（LVAD）支持允许患有先天性心脏病或心肌病的新生儿生长到更大的体重，更适合复杂的手术矫正或心脏移植。一种副躯体左心室辅助器，柏林心脏ExCor，已被fda批准用于儿科应用。虽然这个装置在体外，流出的移植物仍然可能造成冠状动脉/心脏压迫。我们的最终目标是为新生儿开发一种侵入性更小、更可靠的LVAD系统。使能技术将是一个小的（16-18 Fr）双腔插管（DLC），从心尖插入，通过左室和主动脉瓣进入主动脉，左室的引流腔开放，主动脉的输注腔开放。再加上一个血泵，血液从左室抽出并注入主动脉，通过一次插管将左室排出。这种基于dlc的LVAD: 1)只有一个顶点插管，避免了心脏/冠状动脉的压迫，2)有一个更小的顶点插管，消除了体外循环，3)需要更少的创伤性左胸切开术，取代创伤性中胸骨切开术，4)有一个灵活的配置，允许一个更大的体外泵，以获得更强的性能，并增加了一个气体交换器，用于青紫心脏疾病。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。在第一阶段的SBIR中，我们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与商业血泵相结合，将提供完全的左室支持，挽救患病新生儿的生命。它将架起病人康复、移植或进一步的心脏手术的桥梁。具体目标1：

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 Coupled with a blood pump, blood is withdrawn from the LV and infused into the aorta to unload the LV though a single cannulation.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.