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.
ParacorpoReal柏林心脏EXCOR是FDA批准的唯一一种用于
儿科病人。这种脉动隔膜柱塞泵(DDP)体积小/重量轻,便于儿科
耐心地走动。然而,EXCOR的效率只有50%,因为它以不同的速度抽出和泵血
次数(间断脉动流)。这会产生很高的峰值血流速度,这可能会导致血液损伤。
一种准心脏持续流动儿科VAD也已用于较小的儿童。这台离心泵
由于通过引流/输液插管的持续流动,效率很高,但PediMag泵的泵头
必须连接到笨重/笨重的马达,这会阻碍行走。我们之前开发出了一种经根尖到
主动脉(TAA)双腔插管(DLC)用于微创非卧床LVAD,效果良好
96小时初生羔羊的性能/血液相容性。我们的最终目标是开发一种高效的、最低限度的
为儿科患者设计的侵入性准心脏左冠状动脉成形术系统,它结合了小尺寸/重量(行走)
电流间断脉动流量泵(例如EXCOR)的电势)和电流的高效率
连续流泵(如PediMag)。使能技术是一种顺应式隔膜活塞泵
(CDDP),它将顺应室集成到引流和输液出口,以使血流量加倍。
CDDP将是高性能的,因为:1)不间断/连续的血流;2)输液/引流
降低cDDP后负荷/增加cDDP预负荷的顺应室。较低高峰引流/输液
CDDP的流动也将减少血液创伤。初步数据显示,增加合规室
泵送流量由1 L/分钟增加到2 6 L/分钟,峰值流量降低。第一阶段SBIR的目标是
设计并制造了具有最佳顺应室尺寸的cDDP工作样机。这个cDDP将是
用我们之前开发的TAA DLC在羔羊身上进行了测试。具体目标1:设计、制造和测试
测试cDDP。顺应室将集成到cDDP引流和输液出口中。CDDP
将由聚碳酸酯外壳制成,中间带有聚氨基甲酸酯隔膜。三尖瓣可以
将cDDP外壳连接到两个小型硅胶顺应室。最终的原型将进行测试,以确定
在37%甘油模拟环路中1周,以获得性能/可靠性/耐用性。具体目标2:测试cDDP
在羔羊身上工作的原型。CDDP将与TAA DLC相结合,以形成侵入性较小的,
将在10-15公斤的羔羊(n=9)身上进行测试,以评估6小时性能/可靠性和
最初的生物相容性。原型设计/制造/台架测试将在W-Z生物技术公司进行,羔羊
研究将在肯塔基大学进行。我们的cDDP不是对现有技术进行微调,而是
一项新颖的发明,它将使搏动的准心脏VAD具有双倍的效率。这项技术可以
也可用于成人,并可能显著影响心源性休克/过渡到心脏移植治疗。
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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