Development of a Pediatric pVAD

儿科 pVAD 的开发

• 批准号: 6833856
• 负责人: DAVID H J WANG
• 金额: $ 10.51万
• 依托单位: CARDIACASSIST, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-07-01 至 2004-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6833856
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomedical equipment development; cardiac output; circulatory assist; congenital heart disorder; heart dimension /size; hemolysis; hypertrophic myocardiopathy; medical implant science; pediatrics

DESCRIPTION (provided by applicant): In the United States, approximately 4,000 pediatric patients per year require a ventricular assist device (VAD) due to idiopathic cardiomyopathy or congenital heart defects. Despite this tremendous need, there is currently no specially designed VAD commercially available in the US for pediatric use. The ultimate goal of this project is to develop a percutaneous VAD (pVAD) for pediatric patients ranging from 3.5 kg to 50 kg based on our existing adult pVAD system. The proposed system is intended to deliver support of up to 50% of the patient's normal cardiac output. Due to the wide range of patient sizes, and consequent wide variety of support levels needed, the served patient population has been divided into six segments based on patient's body size. For each patient segment, cannula of proper size will be developed for device placement. A pediatric pump will be designed based on the existing adult blood pump. Controller will be redesigned for pediatric application. Feasibility prototypes will be manufactured and tested under simulated clinical use conditions to demonstrate that the proposed design can deliver the required support for each patient segment. Hemolysis testing will be conducted to demonstrate that the proposed design does not cause excessive blood damage. Phase II study includes optimization of the proposed design and animal testing. After successful completion of Phase I and II, clinical trial and commercialization of the proposed device will follow. The proposed system is simple and low cost. Because it is inserted percutaneously, cardiac assistance can be provided quickly and with minimum invasiveness, subsequently minimizing potential complications and promoting quicker recovery. Successful commercialization of this device will provide a new tool for use in pediatric cardiology and surgery, and will help save children's lives.

描述（由申请人提供）： 在美国，由于特发性心肌病或先天性心脏缺陷，每年约有4,000名儿科患者需要心室辅助装置（VAD）。尽管有如此巨大的需求，但目前在美国尚无专门设计的VAD可用于儿科使用。该项目的最终目标是根据现有的成人PVAD系统，为儿科患者开发经皮VAD（PVAD）。该建议的系统旨在提供多达50％患者正常心脏输出的支持。由于患者的大小范围很广，因此需要各种各样的支持水平，因此，根据患者的体型，服务的患者人群已分为六个部分。对于每个患者段，将开发适当尺寸的套管以进行设备放置。小儿泵将根据现有的成人血泵设计。控制器将重新设计用于儿科应用。可行性原型将在模拟的临床使用条件下制造和测试，以证明拟议的设计可以为每个患者段提供所需的支持。将进行溶血测试，以证明所提出的设计不会导致过多的血液损害。第二阶段的研究包括优化拟议的设计和动物测试。成功完成第一阶段和第二阶段后，将随后对拟议设备的临床试验和商业化。提出的系统简单而低成本。由于经皮插入，因此可以快速提供心脏援助，并以最小的侵入性提供，随后最大程度地减少潜在的并发症并促进更快的恢复。该设备的成功商业化将为儿科心脏病学和手术提供新的工具，并有助于挽救儿童的生命。

项目成果

Development of a percutaneous pediatric ventricular assist device.

开发经皮小儿心室辅助装置。

• DOI: 10.1097/01.mat.0000181635.70527.c1
• 发表时间: 2005
• 期刊: ASAIO journal (American Society for Artificial Internal Organs : 1992)
• 作者: Wang,DavidHJ;Smith,DouglasE;Bacha,EmileA;Hijazi,ZiyadM;Magovern,JamesA
• 通讯作者: Magovern,JamesA