Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility
开发用于新生儿和心力衰竭儿童的完全植入式心室辅助装置 - 通过磁悬浮改善血液相容性
基本信息
- 批准号:10029559
- 负责人:
- 金额:$ 74.76万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2020
- 资助国家:美国
- 起止时间:2020-08-01 至 2024-06-30
- 项目状态:已结题
- 来源:
- 关键词:4 year old5 year oldAbdomenAcuteAddressAdultAffectAgeAnimalsAortaBackBerlinBirthBloodBlood PressureBlood flowCaliberCause of DeathChestChildChildhoodChronicCoupledDevelopmentDevicesEnvironmentEvaluationFeasibility StudiesGeometryGrowth and Development functionHeartHeart TransplantationHeart failureHemolysisHemorrhageHospitalsImplantIn VitroIncidenceInfantInfectionIronLeadLeft ventricular structureLength of StayLifeLiquid substanceLocationMagnetismMechanicsMissionModelingMotorNational Heart, Lung, and Blood InstituteNational Institute of Biomedical Imaging and BioengineeringPatientsPerformancePhysiologicalPositioning AttributeProceduresPropertyPumpQuality of lifeRadialResearchRunningSeriesSkinSpeedStrokeSurvival RateSystemTestingThoracotomyThrombosisTimeTouchdownTransplantationTubeUnited StatesUnited States National Institutes of HealthWeighing patientactive controlalternative treatmentblood pumpcongenital heart disorderdesignhemocompatibilityhemodynamicsimplantationimprovedinsightleft ventricular assist deviceneonatepatient mobilitypediatric heart failurepediatric patientspressurepreventresidenceresponseshear stressstroke riskventricular assist device
项目摘要
PROJECT SUMMARY
The annual incidence of pediatric heart failure due to congenital heart disease (CHD) is 1 to 2 cases per 1000
births. Whereas 10,000 to 14,000 children are hospitalized annually in the United States waiting for a new heart,
only 444 transplants were performed in 2016, illustrating the drastic shortage of donor hearts. The only long-
term treatment alternative to a heart transplant is the implantation of a ventricular assist device (VAD), a pump
that helps the failing heart to pump blood until a new heart is available. However, these VADs are too large to
be fully implantable in children under 4 years of age; therefore, these VADs are placed externally near the
abdomen, with tubes running through the skin. These tubes can lead to infection, and they prevent the children
from leaving the hospital for the duration of pump support, which can exceed 1 year. Additionally, the survival
rate of patients weighing less than 5 kg with the currently available VADs is dismal; more than 60% of these
children die after VAD implantation, stroke being the most common cause of death. Therefore, there is a need
to design a safer, fully implantable pediatric VAD to improve the survival of both infants and young children. This
VAD also needs to be adjustable with the child’s growth and development, meaning that it must provide higher
blood flow and pressure as the child grows. The objective of this study is to develop the first fully implantable
VAD (NeoVAD) for infants and young children, which would help the failing heart until a suitable donor heart is
available. In Aim 1, development of a miniature magnetic levitation system to eliminate mechanical wear and
optimize the pump performance is proposed, which will provide a long-term circulatory support. The
hemodynamic performance of the NeoVAD in steady-state flow environments at different physiological operating
points will be investigated in Aim 2. Finally, in Aim 3, systemic hemocompatibility and hemodynamic
performance of the NeoVAD will be evaluated by in vitro and large-animal studies. This pump, after implantation,
would allow pediatric heart failure patients to return to a near-normal life outside the hospital.
This research will give new insights into designing a pump that can support the failing heart for a wide range of
patients, from infants to children weighing up to 20 kg. This wide range of support would eliminate the need to
change VADs or undergo multiple heart transplants as the child grows, both of which are risky procedures. Also,
this research will include an in-depth study of pump-blood interaction across the patient age range, allowing us
to study how blood shear stress is affected by changes in blood flow rate and pressure as the child grows. This
study will enable us to design the first safe, fully implantable VAD for young children, which would
reduce the risk of stroke, bleeding, and infection and improve their chances of survival. We expect that
with the implanted NeoVAD, pediatric CHD patients can live a near-normal life outside the hospital, which
would be a significant improvement in their quality of life.
项目摘要
由于先天性心脏病(CHD)引起的小儿心力衰竭的年发病率为每1000例1至2例
出生。每年在美国每年住院的10,000至14,000名儿童等待新心脏,而
2016年仅进行了444次移植,说明了供体心脏的严重短缺。唯一的长期
术语治疗替代心脏移植的是心室辅助装置(VAD)的植入泵
这有助于失败的心脏抽血,直到有新的心脏可用。但是,这些vad太大了
在4岁以下的儿童中完全植入;因此,这些vad被外部放置在
腹部,管道穿过皮肤。这些管可能会导致感染,并防止孩子
从离开医院的泵支撑持续时间,可能会超过1年。另外,生存
当前可用VAD的体重小于5 kg的患者速率令人沮丧;其中超过60%
儿童在VAD植入后死亡,中风是最常见的死亡原因。因此,有必要
设计一种更安全的,完全可植入的小儿VAD,以改善婴儿和幼儿的生存。这
VAD还需要根据孩子的成长和发展进行调节,这意味着它必须提供更高的
随着孩子的成长,血流和压力。这项研究的目的是开发第一个完全植入
婴儿和幼儿的VAD(NEOOVAD),这将有助于失败的心脏,直到合适的供体心为止
可用的。在AIM 1中,开发微型磁性悬浮系统以消除机械磨损和
提出了优化泵的性能,这将提供长期的电路支持。这
在稳态流动环境中,Neovad在不同的物理工作中的血液动力学性能
点将在AIM 2中进行研究。最后,在AIM 3中,全身血流相容性和血流动力学
Neovad的性能将通过体外和大动物研究来评估。植入后,这个泵
小儿心力衰竭患者可以恢复医院外的近期生活。
这项研究将为设计泵提供新的见解,该泵可以支持各种各样的心脏
从婴儿到儿童加权20公斤的患者。这种广泛的支持将消除
随着孩子的成长,更改VAD或进行多次心脏移植,这两种都是风险的程序。还,
这项研究将包括对整个患者年龄范围内泵血相互作用的深入研究,使我们
研究血液流量变化和随着孩子的增长压力的变化,血液剪应力如何影响。这
研究将使我们能够为幼儿设计第一个安全的,完全可植入的VAD,这将
降低中风,出血和感染的风险,并提高其生存机会。我们期望这一点
借助植入的新疾病,儿科冠心病患者可以在医院外过着近期的生活,
他们的生活质量将是一个重大改善。
项目成果
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{{ truncateString('O. H. FRAZIER', 18)}}的其他基金
Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility
开发用于新生儿和心力衰竭儿童的完全植入式心室辅助装置 - 通过磁悬浮改善血液相容性
- 批准号:
10418720 - 财政年份:2020
- 资助金额:
$ 74.76万 - 项目类别:
Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility
开发用于新生儿和心力衰竭儿童的完全植入式心室辅助装置 - 通过磁悬浮改善血液相容性
- 批准号:
10661591 - 财政年份:2020
- 资助金额:
$ 74.76万 - 项目类别:
Development of a Fully-Implantable Ventricular Assist Device for Neonates and Children with Heart Failure - with Magnetic Levitation to Improve Hemocompatibility
开发用于新生儿和心力衰竭儿童的完全植入式心室辅助装置 - 通过磁悬浮改善血液相容性
- 批准号:
10223928 - 财政年份:2020
- 资助金额:
$ 74.76万 - 项目类别:
Effects of a Pulse Induced by a Constant-Flow Total Cardiac Replacement Device
恒流全心脏置换装置引起的脉冲效应
- 批准号:
8098975 - 财政年份:2009
- 资助金额:
$ 74.76万 - 项目类别:
Effects of a Pulse Induced by a Constant-Flow Total Cardiac Replacement Device
恒流全心脏置换装置引起的脉冲效应
- 批准号:
7735978 - 财政年份:2009
- 资助金额:
$ 74.76万 - 项目类别:
Effects of a Pulse Induced by a Constant-Flow Total Cardiac Replacement Device
恒流全心脏置换装置引起的脉冲效应
- 批准号:
7916554 - 财政年份:2009
- 资助金额:
$ 74.76万 - 项目类别:
A Novel Approach to Cardiac Replacement with Continuous Flow Pumps
使用连续流泵进行心脏置换的新方法
- 批准号:
7466204 - 财政年份:2008
- 资助金额:
$ 74.76万 - 项目类别:
A Novel Approach to Cardiac Replacement with Continuous Flow Pumps
使用连续流泵进行心脏置换的新方法
- 批准号:
7620385 - 财政年份:2008
- 资助金额:
$ 74.76万 - 项目类别:
A Novel Approach to Cardiac Replacement with Continuous Flow Pumps
使用连续流泵进行心脏置换的新方法
- 批准号:
7860659 - 财政年份:2008
- 资助金额:
$ 74.76万 - 项目类别:
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