A Novel Pediatric Pulsatile Rotary Ventricular Pump

新型儿科脉动旋转心室泵

基本信息

批准号：
7925558
负责人：
DANIEL Edward MAZUR
金额：
$ 37.26万
依托单位：
MC3, INC.
依托单位国家：
美国
项目类别：
财政年份：
2008
资助国家：
美国
起止时间：
2008-02-15 至 2013-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7925558
关键词：
Acceleration Accidental Injury Acute Address Adult Animal Model Animals Appointment Blood Blood flow Cardiac Cardiac Surgery procedures Cardiopulmonary Cardiopulmonary Bypass Cardiovascular system Cerebrovascular Circulation Cerebrum Characteristics Childhood Clinical Computer software Cost Savings Development Device Designs Devices Diastole Effectiveness Electronics Equipment Equipment Failure Genes Goals Grant Heart Heart Arrest Heart-Lung Machine Hemodilution Hemolysis Incidence Industry Indwelling Catheter Infant Injury Kidney Laboratories Left Letters Licensing Life Liquid substance Manufacturer Name Marketing Mechanics Medical Device Michigan Modeling Morbidity - disease rate Motor Nature Neonatal Operative Surgical Procedures Organ Outcome Output Patients Pediatric Hospitals Pediatric Research Pediatric Surgical Procedures Pediatrics Performance Perfusion Phase Physicians Physiological Population Positioning Attribute Postdoctoral Fellow Postoperative Period Probability Production Publishing Pulsatile Flow Pump Quality of Care Recovery Reporting Research Research Personnel Resources Risk Safety Sales Sturnus vulgaris Surgeon System Techniques Technology Testing Universities Variant Ventricular Work base blood product blood pump career commercialization congenital heart disorder cost design engineering design experience falls hemodynamics improved in vivo innovation interest manufacturing process meetings neonate novel pre-clinical pressure prevent process optimization product development prototype public health relevance pulmonary function repaired research and development

项目摘要

DESCRIPTION (provided by applicant): A novel, pulsatile, disposable pump (pediatric MPulse) will be researched for pediatric Cardiopulmonary Bypass surgery which offers physiologic pulsatile blood flow, inherently safe management of low extracorporeal volumes, highly accurate very low flow control, and extended durability for long term cardiopulmonary support. These features address ongoing morbidity concerns due to vital organ injury in pediatric CPB patients caused by non-physiologic blood flows, excessive hemodilution, poor cerebral blood flow, and acute injury due to equipment failure and operator error. In addition, the pediatric MPulse presents a new option for pediatric extended cardiac support. The pediatric MPulse uses a passively filled compliant pumping chamber and operates under Starling principles, like the natural heart. The compliant pump chamber passively fills, and the pump produces a discharge flow based on the volume of fluid that is provided. A physiologic pulsatile flow is created under constant RPM conditions through a novel lengthwise variation of the pumping chamber geometry. Inherent safety advantages prevent retrograde flow, maintain safe circuit pressures, and prevent inadvertent draining of the venous reservoir. Phase I objectives have been met. An MPulse pump chamber geometry has been defined and shown to produce target pulsatility above that of current technology over a range of flow conditions representative of pediatric CPB. Performance targets for durability and hemolysis were met. Phase II research will concentrate on refinement of chamber design for improved blood handling and optimization for robust manufacturing processes. Necessary electronic hardware and software will be developed to support animal studies which will be conducted to demonstrate effectiveness and safety in a clinical setting. All device design, manufacturing process optimization and testing activities will be conducted and documented under design controls to facilitate transfer to a manufacturing partner per our Phase III commercialization plans. PUBLIC HEALTH RELEVANCE: This grant will result in the development of a novel pediatric blood pump for pediatric Cardiopulmonary Bypass surgery with extended durability to allow for long term cardiac support following surgery. Currently, no pump system of this type exists for pediatric patients so physicians have limited options when cardiac support post surgery is necessary.

描述（由申请人提供）：将研究一种新型脉动一次性泵（儿科 MPulse），用于儿科心肺旁路手术，该泵提供生理脉动血流、低体外容量的固有安全管理、高精度极低流量控制以及扩展长期心肺支持的耐用性。这些功能解决了儿科 CPB 患者因非生理性血流、过度血液稀释、脑血流不良以及设备故障和操作失误造成的急性损伤导致的重要器官损伤所导致的持续发病率问题。此外，儿科 MPulse 为儿科扩展心脏支持提供了一种新选择。儿科 MPulse 使用被动填充的顺应泵室，并按照 Starling 原理运行，就像自然心脏一样。柔性泵室被动填充，并且泵根据所提供的流体体积产生排出流量。通过泵室几何结构的新颖的纵向变化，在恒定的 RPM 条件下产生生理脉动流。固有的安全优势可防止逆流、维持安全回路压力并防止静脉储液器意外排空。第一阶段的目标已经实现。 MPulse 泵室的几何形状已被定义并被证明可以在代表儿科 CPB 的一系列流动条件下产生高于当前技术的目标脉动。达到了耐久性和溶血的性能目标。第二阶段研究将集中于改进血液处理的腔室设计和优化稳健的制造工艺。将开发必要的电子硬件和软件来支持动物研究，这些研究将在临床环境中证明有效性和安全性。所有设备设计、制造工艺优化和测试活动都将在设计控制下进行和记录，以便根据我们的第三阶段商业化计划转移到制造合作伙伴。公共健康相关性：这笔赠款将用于开发一种用于儿科心肺搭桥手术的新型儿科血泵，该血泵具有更长的耐用性，可在手术后提供长期心脏支持。目前，还没有适用于儿科患者的这种类型的泵系统，因此当术后需要心脏支持时，医生的选择有限。