Integration of Compliance Chambers into Diaphragm Displacement Pump to Double the Pumping Flow of Pediatric Paracorporeal Pulsatile Ventricular Assist Device

将顺应室集成到隔膜排量泵中,使儿科体外脉动心室辅助装置的泵流量加倍

基本信息

  • 批准号:
    10761399
  • 负责人:
  • 金额:
    $ 29.59万
  • 依托单位:
  • 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:
    2023-08-10 至 2025-01-31
  • 项目状态:
    未结题

项目摘要

The paracorporeal Berlin Heart EXCOR is the only FDA-approved ventricular assist device (VAD) for pediatric patients. This pulsatile diaphragm displacement pump (DDP) is small/light weight to facilitate pediatric patient ambulation. However, EXCOR efficiency is only 50% since it withdraws and pumps blood at different times (interrupted pulsatile flow). This generates a high peak blood flow rate, which may cause blood damage. A paracorporeal continuous flow PediMag VAD has also been used in smaller children. This centrifugal pump is highly efficient due to the constant flow through the drainage/infusion cannulas, but the PediMag pump head must be attached to a bulky/heavy motor, which hinders ambulation. We previously developed a transapical to aorta (TAA) double lumen cannula (DLC) for a minimally invasive ambulatory LVAD, which showed excellent 96 hr performance/hemocompatibility in neonate lambs. Our ultimate goal is to develop an efficient, minimally invasive, paracorporeal LVAD system for pediatric patients, which combines the small size/weight (ambulation potential) of current interrupted pulsatile flow pump (e.g EXCOR) and the current high efficiency of a continuous flow pump (e.g PediMag). The enabling technology is a compliant diaphragm displacement pump (cDDP), which has compliance chambers integrated into the drainage and infusion outlets to double blood flow. The cDDP will be high performing due to: 1) noninterrupted/continuous blood flow; 2) infusion/drainage compliance chambers that decrease cDDP afterload/increase cDDP preload. The lower peak drainage/infusion flow of the cDDP will also reduce blood trauma. Preliminary data showed that adding compliance chambers increased pumping flow from 1.1 to 2.6 L/min and decreased peak flow rate. The Phase I SBIR objective is to design and fabricate a cDDP working prototype with optimal compliance chambers size. This cDDP will be tested in lambs with our previously developed TAA DLC. Specific Aim 1: To design, fabricate, and bench test a cDDP. Compliance chambers will be integrated into the cDDP drainage and infusion outlets. The cDDP will be made of polycarbonate housing with a polyurethane diaphragm in the middle. A tricuspid valve will connect the cDDP housing to the two small silicone compliance chambers. The final prototype will be tested for 1 week in a 37% glycerin mock loop for performance/reliability/durability. Specific Aim 2: To test the cDDP working prototype in lambs. The cDDP will be combined with the TAA DLC to form a less invasive, ambulatory LVAD, which will be tested in 10-15 kg lambs (n=9) to evaluate 6 hr performance/reliability and initial biocompatibility. Prototype design/fabrication/bench testing will be done at W-Z Biotech, and the lamb studies will be done at the University of Kentucky. Rather than fine-tuning existing technology, our cDDP is a novel invention, which will enable a pulsatile paracorporeal VAD with doubled efficiency. This technology can also be used in adults and may significantly impact cardiogenic shock/bridge to heart transplant management.
旁心柏林心脏EXCOR是FDA批准的唯一心室辅助装置(VAD), 儿科患者。该脉动隔膜置换泵(DDP)体积小/重量轻, 病人救护车。然而,EXCOR效率仅为50%,因为它以不同的速度抽取和泵送血液, 次(间断搏动流)。这会产生高峰血液流速,可能导致血液损伤。 一个paracentral连续流PediMag VAD也已用于较小的儿童。该离心泵 由于通过引流/输注套管的恒定流量,因此具有高效率,但PediMag泵头 必须连接到一个笨重的/沉重的电机,这阻碍了Amplitude。我们以前开发了一种经心尖, 主动脉(TAA)双腔插管(DLC)用于微创非卧床LVAD,表现出色 新生羔羊96小时性能/血液相容性。我们的最终目标是开发一种高效、最低限度的 用于儿科患者的有创、并行LVAD系统,该系统结合了小尺寸/重量(amplitude) 当前中断的脉动流泵(例如EXCOR)的效率和当前高效率的 连续流泵(例如PediMag)。使能技术是一个顺应隔膜排量泵 (cDDP),其具有整合到引流和输注出口中的顺应性腔室,以使血流加倍。 cDDP将具有高性能,因为:1)无中断/连续血流; 2)输注/引流 降低cDDP后负荷/增加cDDP前负荷的顺应性腔室。引流/输注峰值较低 cDDP的流动也将减少血液创伤。初步数据显示,增加合规室 将泵送流量从1.1 L/min增加到2.6 L/min,并降低峰值流速。第一阶段SBIR的目标是 设计并制作了具有最佳顺应腔尺寸的cDDP工作原型。该cDDP将是 用我们以前开发的TAA DLC在羔羊中进行了测试。具体目标1:设计、制造和调试 测试cDDP。顺应性腔室将集成到cDDP引流和输注出口中。cDDP 将由聚碳酸酯外壳制成,中间带有聚氨酯隔膜。三尖瓣 将cDDP外壳连接到两个小型硅胶顺应性腔室。最终的原型将进行测试, 在37%甘油模拟环中使用1周,以提高性能/可靠性/耐用性。具体目标2:检测cDDP 在羊羔身上做原型cDDP将与TAA DLC结合,形成一种侵入性较小的, 非卧床LVAD,将在10-15 kg羔羊(n=9)中进行试验,以评价6小时性能/可靠性, 初始生物相容性。原型设计/制造/台架测试将在W-Z Biotech完成, 研究将在肯塔基州大学进行。我们的cDDP不是对现有技术进行微调, 本发明是一种新颖的发明,它将使脉动式旁路VAD具有加倍的效率。这项技术可以 也可用于成人,并可能显著影响心源性休克/心脏移植管理的过渡。

项目成果

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Stephen R Topaz其他文献

Stephen R Topaz的其他文献

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{{ truncateString('Stephen R Topaz', 18)}}的其他基金

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
  • 财政年份:
    2023
  • 资助金额:
    $ 29.59万
  • 项目类别:
Development of a Minimally Invasive Single Cannulation, Compact Single Port Pulsatile Ventricular Assist Device (sppVAD) for Total LV Support
开发用于全面左心室支持的微创单插管、紧凑型单端口脉动心室辅助装置 (sppVAD)
  • 批准号:
    10259308
  • 财政年份:
    2021
  • 资助金额:
    $ 29.59万
  • 项目类别:
Development of Percutaneous DLC for Total Cavo-pulmonary Assistance
用于全 Cavo 肺辅助的经皮 DLC 的开发
  • 批准号:
    9141450
  • 财政年份:
    2016
  • 资助金额:
    $ 29.59万
  • 项目类别:
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
  • 批准号:
    8712075
  • 财政年份:
    2014
  • 资助金额:
    $ 29.59万
  • 项目类别:
Development of a 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
  • 批准号:
    9555884
  • 财政年份:
    2014
  • 资助金额:
    $ 29.59万
  • 项目类别:

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