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An innovative minimally invasive modular right ventricular assist device

An innovative minimally invasive modular right ventricular assist device
创新的微创模块化右心室辅助装置
批准号:
571041-2021
负责人:
KADEM, LyesL
金额:
$13.34万
依托单位:
依托单位国家:
加拿大
项目类别:
Alliance Grants
财政年份:
2022
资助国家:
加拿大
项目状态:
已结题
起止时间:
2022-01-01 至 2023-12-31

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中文摘要
翻译
这一拟议项目的总体目标是设计、优化和测试一种用于治疗右心衰竭的创新心脏泵(右室模块心脏)的安全性/有效性。右心衰竭是慢性肺病和左心疾病的常见并发症,导致生活质量下降,增加患者死亡率和发病率,并造成巨大的社会和经济负担。目前还没有专门用于右心衰竭长期动态治疗的医疗设备或药物。通过与Putle Medical Devices Inc.(PMD)的合作,我们将设计、开发和测试一种新型的长期血管内右室辅助装置。方法:研究方法。在PMD设计左心室模块心脏的经验基础上,我们将设计、开发和测试第一个长期血管内右室辅助装置。该提案围绕五个相辅相成的目标展开:目标#1:设计新型右室模块心脏的血管内螺旋桨;目标#2:优化微磁联轴器的设计,以实现右室支持;目标#3:优化右室模块心脏的肺植入;目标#4:体外评估其性能和可靠性;以及目标#5:体外证明其血液相容性。右室模块心脏将代表着医疗设备发展中的一项技术突破,并将扰乱右心衰竭的自然历史。这一翻译项目将对加拿大人的健康、对模拟加拿大医疗器械行业以及对高素质人才的培训产生重大影响。
英文摘要
The overall objective of this proposed project is to design, optimize and test the safety/efficacy of an innovative novel cardiac pump (right ventricular ModulHeart) for the treatment of right heart failure.BACKGROUND/RATIONALE. Right heart failure is a common complication of chronic lung and left heart disease leading to decreased quality of life, increased patient mortality and morbidity, and significant societal and economic burden. There are currently no medical devices or drugs dedicated to long-term ambulatory management of right heart failure. Through our collaboration with Puzzle Medical Devices Inc. (PMD), we will design, develop, and test a novel long-term endovascular right ventricular assist device. METHODS. Building on PMD's experience with the design of a left ventricular ModulHeart, we will design, develop and test the first long-term endovascular right ventricular assist device. The proposal is articulated around five strong complementary aims: Aim#1: Design the new endovascular propeller of the right ventricular ModulHeart; Aim#2: Optimize the design of the micro-magnetic coupling to enable right ventricular support; Aim#3: Optimize the pulmonary implantation of the right ventricular ModulHeart; Aim#4: In vitro evaluate its performance and reliability; and Aim#5: In vitro demonstrate its hemocompatibility.EXPECTED OUTCOMES SIGNIFICANCE. The right ventricular ModulHeart will represent a technological breakthrough in the development of medical devices and will disrupt the natural history of right heart failure. This translational project will lead to significant impacts on the health of Canadians, on simulating the Canadian medical device industry and on the training of Highly Qualified Personnel.
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