Pediatric Transapical Double Lumen Cannula with Integrated Compliance Chambers Doubles Flow of Paracorporeal Pulsatile VAD

带有集成顺应室的儿科经心尖双腔插管使体外脉动 VAD 的流量加倍

基本信息

批准号：
10699790
负责人：
Stephen R Topaz
金额：
$ 27.54万
依托单位：
W-Z BIOTECH, LLC
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-06-01 至 2024-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10699790
关键词：
Adult Animals Apical Berlin Biotechnology Blood Blood flow Cannulas Cannulations Cardiac Cardiac Surgery procedures Cardiogenic Shock Cardiomyopathies Child Childhood Complex Coupled Dedications Devices Drainage procedure Engineering FDA approved Frequencies Glycerol Goals Head Heart Heart Transplantation Heart failure Implant Infusion procedures Interruption Kentucky Laboratory Animal Production and Facilities Left Legal patent Letters Motor Myocarditis North America Output Patients Performance Phase Polyurethanes Publications Pump Research Support Respiratory Diaphragm Scientist Silicones Small Business Innovation Research Grant Sternotomy Stroke Volume Surgeon System Technology Testing Thoracotomy Time Trauma Universities Withdrawal biomaterial compatibility blood damage blood pump cardiac repair commercialization congenital heart disorder design experience fabrication improved improved outcome in vivo interest light weight minimally invasive multidisciplinary pediatric heart failure pediatric patients performance tests pressure prototype research and development respiratory shear stress ventricular assist device

项目摘要

Pediatric patients with severe heart failure require a ventricular assist device (VAD). The paracorporeal Berlin Heart EXCOR is still the only FDA-approved VAD for pediatric patients. This diaphragm displacement pump is small/light weight to facilitate ambulation. However, EXCOR withdraws and pumps blood at different times for interrupted pulsatile blood flow, with its drainage and infusion cannulas functioning only half the time (50% efficiency). EXCOR also generates a high peak blood flow rate, which may cause blood damage. A paracorporeal continuous flow (PediMag/CentriMag) VAD has also been used with Berlin Heart cannulas in smaller children, but its bulky/heavy motor hinders ambulation. Pediatric paracorporeal VADs require two separate cannulas for withdrawal and infusion and their installation requires an invasive median sternotomy, which complicates later surgery for heart transplant or repair. Our ultimate goal is to develop a minimally invasive, high efficiency paracorporeal pulsatile diaphragm displacement VAD system for pediatric patents. The enabling technology is a transapical double lumen cannula (DLC) with integrated compliance chambers that features: 1) Single transapical cannulation via less invasive, small left thoracotomy; 2) Two integrated compliance chambers that: a) Continuously withdraw/infuse blood to increase efficiency for higher blood flow rates; b) Adjust continuous flow fluctuation for desired pulsatility; c) Reduce peak blood flow rate to mitigate blood trauma; d) Reduce infusion lumen peak pressure, decreasing pump afterload to enhance pump output; e) Allow smooth withdrawal to infusion transition for high frequency pumping. Bench testing of an initial transapical DLC with integrated compliance chambers prototype with EXCOR showed double pumping flow with decreased peak pump flow. The Phase I SBIR objective: We will redesign a transapical DLC with optimal minimal compliance chambers and conduct performance testing in lambs. Specific Aim 1: To design, fabricate, and bench test the high efficiency, transapical DLC with integrated compliance chambers. The transapical DLC compliance chambers will be integrated into the drainage and infusion outlets. The 24 Fr main DLC body will be one-piece reinforced polyurethane. The super-elastic silicone compliance chambers will be very small with 50% stroke volume. The final prototype will be tested for 1 week in an EXCOR mock loop with 37% glycerin for performance/reliability/durability. Specific Aim 2: To test the new 24 Fr transapical DLC with compliance chambers in an EXCOR VAD circuit in lambs (n=8). These lamb (10-15 kg) studies will investigate ease of transapical deployment, 6 hr in vivo performance/reliability, and initial biocompatibility. Prototype design/fabrication/bench testing will be done at W-Z Biotech, and the animal studies will be done at the University of Kentucky. Upon completion, the commercialized transapical DLC with integrated compliance chambers will provide a less invasive paracorporeal pulsatile VAD with doubled efficiency. This technology can also be used in adults and may significantly impact cardiogenic shock/bridge to heart transplant management.

患有严重心力衰竭的儿科患者需要心室辅助装置（VAD）。体外 Berlin Heart EXCOR 仍然是 FDA 唯一批准用于儿科患者的 VAD。这个隔膜位移泵体积小/重量轻，便于移动。然而，EXCOR 的抽血和泵血时间不同脉动血流中断的次数，其引流和输注插管仅在一半时间起作用（50% 效率）。 EXCOR还会产生很高的峰值血流速率，这可能会导致血液损伤。一个体外连续流 (PediMag/CentriMag) VAD 也已与柏林心脏插管一起用于较小的儿童，但其庞大/沉重的电机阻碍了行走。儿科体外 VAD 需要两个用于抽出和输注的单独插管及其安装需要侵入性正中胸骨切开术，这使得以后的心脏移植或修复手术变得复杂。我们的最终目标是开发一个最小化的有创、高效的体外脉动隔膜位移 VAD 系统获得儿科专利。支持技术是带有集成顺应室的经心尖双腔插管 (DLC) 其特点是： 1) 通过侵入性较小的小型左胸廓切开术进行单次经心尖插管； 2) 两个集成顺应室： a) 连续抽取/输注血液以提高效率以获得更高的血流量费率； b) 调节连续流量波动以获得所需的脉动； c) 降低峰值血流量以缓解血液外伤； d) 降低输液管腔峰值压力，降低泵后负荷，提高泵输出量； e) 允许平滑退出到输注过渡以进行高频泵送。初始台架测试具有 EXCOR 集成顺应室原型的经心尖 DLC 显示双泵送流量峰值泵流量降低。第一阶段 SBIR 目标：我们将重新设计具有最佳性能的经心尖 DLC 最小合规室并对羔羊进行性能测试。具体目标 1：设计、制造并测试具有集成顺应室的高效、经心尖 DLC。经心尖 DLC 顺应室将集成到引流和输液出口中。 24 Fr 主要 DLC 主体将是一件式强化聚氨酯。超弹性硅胶顺应室将非常小，每搏输出量为 50%。最终原型将在 EXCOR 模拟循环中测试 1 周含有 37% 甘油，以提高性能/可靠性/耐用性。具体目标 2：测试新型 24 Fr 经心尖治疗羔羊 EXCOR VAD 电路中具有顺应室的 DLC (n=8)。这些羔羊（10-15公斤）研究将研究经心尖部署的难易程度、6 小时体内性能/可靠性以及初始生物相容性。原型设计/制造/台架测试将在 W-Z Biotech 完成，动物研究将在肯塔基大学。完成后，具有集成合规性的商业化经心尖 DLC 腔室将提供侵入性较小的体外脉动 VAD，效率加倍。这项技术可以也可用于成人，可能会显着影响心源性休克/心脏移植管理的桥梁。