A Novel Pediatric Pulsatile Rotary Ventricular Pump

描述（由申请人提供）：将研究一种用于儿科心脏搭桥手术的新型脉动式一次性泵（儿科MPulse），该泵可提供生理脉动血流、低体外容量的固有安全管理、高度准确的极低流量控制以及长期心肺支持的延长耐用性。这些功能解决了由于非生理性血流、过度血液稀释、脑血流不良以及设备故障和操作员错误引起的急性损伤导致的儿科CPB患者重要器官损伤引起的持续发病率问题。此外，儿科MPulse为儿科扩展心脏支持提供了一种新的选择。儿科MPulse使用被动填充的顺应性泵室，并根据Starling原理运行，就像天然心脏一样。顺应性泵室被动地填充，并且泵基于所提供的流体的体积产生排出流。在恒定RPM条件下，通过泵送室几何形状的新颖纵向变化产生生理脉动流。固有的安全性优势可防止逆流，保持安全回路压力，并防止静脉储血器意外引流。第一阶段的目标已经实现。已经定义了MPulse泵腔几何形状，并证明其在代表儿科CPB的一系列流量条件下产生的目标脉动性高于当前技术。满足耐久性和溶血的性能目标。第二阶段的研究将集中在改进血液处理和优化稳健的制造工艺的腔室设计的完善。将开发必要的电子硬件和软件，以支持动物研究，这些研究将用于证明临床环境中的有效性和安全性。所有器械设计、制造过程优化和测试活动将在设计控制下进行并记录，以便于根据我们的III期商业化计划转移给制造合作伙伴。公共卫生相关性：这项拨款将导致开发一种新型的儿科血液泵，用于儿科心脏搭桥手术，具有延长的耐用性，以便在手术后提供长期的心脏支持。目前，还没有这种类型的泵系统用于儿科患者，因此当需要术后心脏支持时，医生的选择有限。

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.