Advanced Ventricular Assist Device with Pulse Augmentation and Automatic Regurgitant Flow Shutoff

具有脉冲增强和自动回流关闭功能的先进心室辅助装置

基本信息

批准号：
9313928
负责人：
Kiyotaka Fukamachi
金额：
$ 11.89万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-07-15 至 2019-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9313928
关键词：
3D Print Accidents Acute Address Animals Aortic Valve Insufficiency Attenuated Back Blood Cardiac Cessation of life Chronic Clinic Clinical Data Destinations Development Device Designs Devices Diastole Dimensions Evaluation Event Exploratory/Developmental Grant Goals Grant Heart failure Hemolysis Housing In Vitro Interruption Left Liquid substance Mechanics Obstruction Outcome Output Patient-Focused Outcomes Patients Performance Physiologic pulse Physiological Plasticizers Positioning Attribute Pulsatile Flow Pump Risk Suction Suspensions Syncope System Systole Testing Thrombosis Titanium Transplantation Ventricular Weaning aortic valve biomaterial compatibility design experimental study hemodynamics improved improved outcome in vitro testing in vivo innovation left ventricular assist device pressure prevent prototype screening total artificial heart ventricular assist device

项目摘要

Project Summary Continuous-flow (CF) rotary pumps have been widely used to treat patients with end-stage heart failure. However, all existing or developing CF devices have the following clinical limitations: reduced arterial pulsatility, threat of pump thrombosis or hemolysis, risk of syncope and death from backflow during pump stoppage, inability to non-invasively evaluate weanability by pump-off test, narrow operating specifications meaning there is no universal device for use as both left and right ventricular assist devices (LVAD and RVAD, respectively), and potential inlet obstruction from suctioning of left ventricular wall into the inlet. To eliminate or minimize these drawbacks, we are developing an innovative, advanced ventricular assist devices (AVAD), derived from features of Cleveland Clinic's LVAD, RVAD, and continuous-flow total artificial heart (CFTAH). The following goals are attainable: maintain physiological pulsatility, reduce the risk of pump thrombosis or hemolysis, prevent backflow by enabling automatic shutoff, enable non-invasive evaluation of pump weanability, demonstrate wide operating specifications, enabling use of the AVAD as either an LVAD or RVAD, and avoid suction events by automatically attenuating pump output. The goals of this proposal are to address the feasibility of the proposed concept, take the first steps toward refinement, and demonstrate the intended mechanical function in vivo. The Specific Aims are: (1) analyze and refine the pump design features by a computational fluid dynamics study and in vitro testing in a mock circulatory loop, to simulate varying hemodynamic events, (2) fabricate one pump with three-dimensional (3D) printed plastic housing and impellers suitable for preliminary bench studies and one titanium version pump for acute in vivo experiments, (3) perform in vitro system characterization and hemolysis testing to verify AVAD system performance, and (4) evaluate system performance in three acute in vivo experiments under varying physiological perturbations to demonstrate mechanical functional goals and biocompatibility screening. After proving the feasibility of this totally new VAD design in this R21 program, we will apply for an R01 grant to further refine the device design, perform bench endurance testing, and carry out chronic animal studies for biocompatibility testing. The proposed AVAD, with many advanced features, will improve the outcomes of patients with severe heart failure, providing safe and effective cardiac support as a bridge to transplant and/or destination therapy.

项目概要连续流（CF）旋转泵已广泛用于治疗终末期心力衰竭患者。然而，所有现有或正在开发的 CF 装置都具有以下临床局限性：动脉搏动降低、泵血栓或溶血的威胁、停泵期间回流造成晕厥和死亡的风险，无法通过停泵测试非侵入性地评估脱机能力，狭窄的操作规范意味着存在不是可同时用作左心室辅助装置和右心室辅助装置（分别为 LVAD 和 RVAD）的通用装置，以及左心室壁吸入入口造成的潜在入口阻塞。消除或最小化针对这些缺点，我们正在开发一种创新的、先进的心室辅助装置（AVAD），源自克利夫兰诊所的 LVAD、RVAD 和连续流全人工心脏 (CFTAH) 的特点。下列目标是可以实现的：维持生理搏动，降低泵血栓或溶血的风险，通过自动关闭来防止回流，实现泵脱机性的非侵入性评估，展示广泛的操作规范，允许将 AVAD 用作 LVAD 或 RVAD，并避免通过自动衰减泵输出来减少吸入事件。该提案的目标是解决提出的概念的可行性，迈出完善的第一步，并展示预期的效果体内机械功能。具体目标是： (1) 通过以下方法分析和完善泵的设计特征：计算流体动力学研究和模拟循环回路中的体外测试，以模拟不同的血流动力学事件，(2) 制造一台带有三维 (3D) 打印塑料外壳和叶轮的泵适用于初步实验室研究和一个用于急性体内实验的钛泵，(3) 执行体外系统表征和溶血测试，以验证 AVAD 系统性能，以及 (4) 评估在不同生理扰动下的三个急性体内实验中的系统性能展示机械功能目标和生物相容性筛选。证明了这个方案的可行性后在这个R21计划中全新的VAD设计，我们将申请R01拨款来进一步完善设备设计，进行台架耐久性测试，并进行长期动物研究以进行生物相容性测试。这提出的 AVAD 具有许多先进的功能，将改善严重心力衰竭患者的预后，提供安全有效的心脏支持，作为移植和/或目标治疗的桥梁。

项目成果

期刊论文数量（5）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Effects of blood pump orientation on performance: In vitro assessment of universal advanced ventricular assist device.

血泵方向对性能的影响：通用先进心室辅助装置的体外评估。

DOI：
发表时间：
2020-10
期刊：
影响因子：
2.4
作者：
Miyamoto, Takuma;Kado, Yuichiro;Polakowski, Anthony R;Horvath, David J;Kuban, Barry D;Fukamachi, Kiyotaka;Karimov, Jamshid H
通讯作者：
Karimov, Jamshid H

Characterization and Development of Universal Ventricular Assist Device: Computational Fluid Dynamics Analysis of Advanced Design.

通用心室辅助装置的表征和开发：先进设计的计算流体动力学分析。

DOI：
发表时间：
2022-08-01
期刊：
影响因子：
0
作者：
Goodin, Mark S;Showalter, Michael S;Horvath, David J;Kuban, Barry D;Flick, Christine R;Polakowski, Anthony R;Fukamachi, Kiyotaka;Karimov, Jamshid H
通讯作者：
Karimov, Jamshid H

The design modification of advanced ventricular assist device to enhance pulse augmentation and regurgitant flow shut-off.

先进心室辅助装置的设计修改，以增强脉冲增强和反流关闭。

DOI：
发表时间：
2019-10
期刊：
影响因子：
2.4
作者：
Miyamoto, Takuma;Byram, Nicole;Karimov, Jamshid H;Adams, Joseph;Dessoffy, Raymond;Kuban, Barry D;Gao, Shengqiang;Horvath, David J;Fukamachi, Kiyotaka
通讯作者：
Fukamachi, Kiyotaka

Universal ventricular assist device for right and left circulatory support: the Cleveland Clinic concept.

用于左右循环支持的通用心室辅助装置：克利夫兰诊所的概念。

DOI：
发表时间：
2021-03
期刊：
影响因子：
0
作者：
Karimov, Jamshid H;Polakowski, Anthony R;Fukamachi, Kiyotaka;Miyamoto, Takuma;Flick, Christine
通讯作者：
Flick, Christine

An advanced universal circulatory assist device for left and right ventricular support: First report of an acute in vivo implant.

用于左心室和右心室支持的先进通用循环辅助装置：急性体内植入的第一份报告。

DOI：
发表时间：
2020-09
期刊：
影响因子：
0
作者：
Miyamoto, Takuma;Kado, Yuichiro;Horvath, David J;Kuban, Barry D;Sale, Shiva;Fukamachi, Kiyotaka;Karimov, Jamshid H
通讯作者：
Karimov, Jamshid H