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

• 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
• 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

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.

严重心力衰竭的小儿患者需要心室辅助装置（VAD）。 parac体 柏林心脏的excor仍然是儿科患者唯一的FDA批准VAD。这种膜片位移 泵的重量很小，可以促进行走。但是，excor在不同的 中断脉冲血流的时间，其排水和输注插管仅在一半的时间内发挥作用 （效率为50％）。 Excor还会产生高峰值血流，这可能会导致血液损伤。一个 体形连续流（Pedimag/Centrimag）VAD也已与柏林心脏插管一起使用 较小的孩子，但其庞大/重型运动阻碍了流动。小儿副体vads需要两个 单独的插管进行戒断和输液及其安装需要侵入性的胸骨手术， 这使以后的心脏移植或修复手术复杂化。我们的最终目标是最少开发 侵入性，高效率的小儿专利的体体脉冲膜片位移系统。 促成技术是具有集成合规室的跨速双管道套管（DLC） 特征：1）通过侵入性较小的左胸腔切开术的单个跨副插管； 2）两个集成 合规室：a）连续退出/注入血液以提高血流量的效率 费率； b）调节所需脉动性的连续流动波动； c）降低血流量以减轻 血创伤； d）降低输注管腔峰值压力，减少泵后负载以增强泵输出； e）允许在高频抽水的输注过渡中平稳提取。初始测试 带有excor的集成合规室原型的跨速DLC显示双抽水流 峰值泵流量减少。 I阶段SBIR目标：我们将重新设计具有最佳的跨速度DLC 最小的合规室并在羔羊中进行性能测试。特定目标1：设计， 使用集成的依从性室进行制造和台式测试高效式DLC。 跨副DLC依从性室将集成到排水和输液出口中。 24 fr 主DLC主体将是一件式增强聚氨酯。超弹性有机硅依从性室将 非常小，中风量为50％。最终原型将在Excor模拟循环中测试1周 具有37％的甘油，可用于性能/可靠性/耐用性。特定目标2：测试新的24 FR Transapical DLC在羔羊中的Excor VAD电路中具有合规室（n = 8）。这些羔羊（10-15公斤）研究 将研究易于跨层的部署，体内性能/可靠性6个小时的易于体验和最初的生物相容性。 原型设计/制造/台式测试将在W-Z Biotech进行，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跨速度DLC 钱伯斯将提供侵入性较少的巨型脉动脉动VAD，并具有两倍的效率。这项技术可以 还可以在成人中使用，并可能会显着影响心脏源性休克/桥梁对心脏移植管理。