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
• 负责人: O. H. FRAZIER
• 金额: $ 78.79万
• 依托单位: TEXAS HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10661591
• 关键词: 4 year old; 5 year old; Abdomen; Acute; Address; Adult; Affect; Age; Animals; Aorta; Back; Berlin; Birth; Blood; Blood Pressure; Blood flow; Cause of Death; Chest; Child; Childhood; Chronic; Coupled; Development; Devices; Diameter; Environment; Evaluation; Feasibility Studies; Geometry; Growth and Development function; Heart; Heart Transplantation; Heart failure; Hemolysis; Hemorrhage; Hospitalization; Hospitals; Implant; In Vitro; Incidence; Infant; Infection; Iron; Left ventricular structure; Length of Stay; Life; Liquid substance; Location; Magnetism; Mechanics; Mission; Motor; National Heart, Lung, and Blood Institute; National Institute of Biomedical Imaging and Bioengineering; Patients; Performance; Physiological; Positioning Attribute; Procedures; Property; Pump; Quality of life; Radial; Research; Risk Reduction; Running; Series; Skin; Speed; Stroke; Survival Rate; System; Testing; Thoracotomy; Thrombosis; Time; Touchdown; Transplantation; Tube; United States; United States National Institutes of Health; Weighing patient; active control; alternative treatment; blood pump; congenital heart disorder; design; hemocompatibility; hemodynamics; implantation; improved; insight; left ventricular assist device; neonate; patient mobility; pediatric heart failure; pediatric patients; pressure; prevent; residence; response; shear stress; sheep model; stroke risk; transplantation therapy; ventricular assist device

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.

项目总结

项目成果

Numerical and Experimental Approach to Characterize a BLDC Motor with Different Radial-gap to Improve Hemocompatibility Performance.

用于表征具有不同径向间隙的 BLDC 电机以提高血液相容性性能的数值和实验方法。

• DOI: 10.1109/embc44109.2020.9175989
• 发表时间: 2020
• 期刊: Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
• 作者: Wang,Yaxin;Karnik,Shweta;Smith,PAlex;Elgalad,Abdelmotagaly;Frazier,OH;Kurita,Nobuyuki
• 通讯作者: Kurita,Nobuyuki

Blood-contacting magnetic levitation bearing design using computational fluid dynamics for haemocompatibility.

使用计算流体动力学实现血液相容性的血液接触磁悬浮轴承设计。

• DOI: 10.1109/embc40787.2023.10341056
• 发表时间: 2023
• 期刊: Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
• 作者: Nissim,Lee;Karnik,Shweta;Kiang,Simon;Tedesco,Victor;Ogiwara,Eiji;Kurita,Nobuyuki;Wang,Yaxin;Frazier,OHoward;Fraser,KatharineH
• 通讯作者: Fraser,KatharineH

Personalized Numerical Cardiovascular Model with Weight Growth for Evaluating Pediatric Left Ventricular Assist Devices: Derivation from an Experimental Mock Circulatory Loop.

用于评估儿科左心室辅助装置的具有体重增长的个性化数字心血管模型：源自实验模拟循环回路。

• DOI: 10.1007/s10439-023-03376-x
• 发表时间: 2024
• 期刊: Annals of biomedical engineering
• 影响因子: 3.8
• 作者: Tran,Phong;Tedesco,Victor;Kiang,Simon;Karnik,Shweta;Nguyen,David;Frazier,OH;Fraser,KatharineH;Wang,Yaxin
• 通讯作者: Wang,Yaxin

Numerical and Experimental Analysis for a Magnetic Levitation System in a Hemocompatibility Assessment Platform.

血液相容性评估平台中磁悬浮系统的数值和实验分析。

• DOI: 10.1109/embc48229.2022.9870994
• 发表时间: 2022
• 期刊: Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
• 作者: Tedesco,Victor;Kiang,Simon;Karnik,Shweta;Smith,PAlex;Nissim,Lee;Fraser,KatherineH;Kurita,Nobuyuki;Frazier,OH;Wang,Yaxin
• 通讯作者: Wang,Yaxin

Physiological Control Algorithm for a Pulsatile-flow 3D Printed Circulatory Model to Simulate Human Cardiovascular System.

用于模拟人体心血管系统的脉动流 3D 打印循环模型的生理控制算法。

• DOI: 10.1109/embc48229.2022.9871836
• 发表时间: 2022
• 期刊: Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference
• 作者: Peak,Preston;Tedesco,Victor;Kiang,Simon;Smith,PAlex;Nissim,Lee;Fraser,KatherineH;Frazier,OH;Wang,Yaxin
• 通讯作者: Wang,Yaxin