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
- 来源:
- 关键词:AdultAortaApicalBerlinBiotechnologyBloodBlood flowCannulasCardiacCardiogenic ShockCardiomyopathiesChildChildhoodComplexCoupledDataDevicesDiastoleDrainage procedureEngineeringFDA approvedFrequenciesGlycerolGoalsHeadHeartHeart TransplantationHeart failureHousingImplantInfusion proceduresInterruptionKentuckyLaboratory Animal Production and FacilitiesLungMembraneMoldsMotorMovementMyocarditisPatientsPerformancePhasePolyurethanesPublicationsPulsatile FlowPumpResearch SupportRespiratory DiaphragmScientistSiliconesSmall Business Innovation Research GrantStressSurgeonSystemSystoleTechnologyTestingThrombosisTimeTraumaTricuspid valve structureUniversitiesVacuumWeightWithdrawalbiomaterial compatibilityblood damageblood pumpcommercializationcongenital heart disorderdesignexperiencefabricationflexibilityhemocompatibilityimprovedimproved outcomein vivoinnovationinventionleft ventricular assist devicelight weightminimally invasivemultidisciplinaryneonatenovelpediatric heart failurepediatric patientspolycarbonatepressureprototyperesearch and developmentshear stressventricular assist device
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
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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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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