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，每年约有 4,000 名儿童患者因特发性心肌病或先天性心脏缺陷而需要心室辅助装置 (VAD)。尽管有如此巨大的需求，但目前在美国还没有专门设计的供儿科使用的市售 VAD。该项目的最终目标是在我们现有的成人pVAD系统的基础上，为3.5公斤至50公斤的儿科患者开发一种经皮VAD（pVAD）。所提出的系统旨在为患者正常心输出量的 50% 提供支持。由于患者体型多种多样，因此需要的支持水平也多种多样，因此所服务的患者群体根据患者的体型分为六个部分。对于每个患者部位，将开发适当尺寸的插管以用于装置放置。儿科泵将在现有成人血泵的基础上设计。控制器将针对儿科应用进行重新设计。可行性原型将在模拟临床使用条件下制造和测试，以证明所提出的设计可以为每个患者群体提供所需的支持。将进行溶血测试，以证明所提出的设计不会造成过度的血液损伤。第二阶段研究包括优化拟议设计和动物测试。在成功完成第一阶段和第二阶段后，拟议设备的临床试验和商业化将随之而来。所提出的系统简单且成本低。由于它是经皮插入的，因此可以以最小的侵入性快速提供心脏辅助，从而最大限度地减少潜在的并发症并促进更快的康复。该设备的成功商业化将为儿科心脏病学和外科手术提供一种新工具，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