Wampler R K, Aboul-Hosn W, Cleary M, Saunders M
Johnson and Johnson Interventional Systems, Rancho Cordova, CA 95670.
ASAIO J. 1993 Jul-Sep;39(3):M218-23.
The first generation Hemopump is a VAD based on a catheter mounted intraarterial axial flow blood pump that is placed through the femoral artery. Blood is withdrawn from the left ventricle through a transvalvular inflow cannula and pumped into the aorta. Clinical trials have demonstrated hemodynamic efficacy, improved survival, and low hemolysis in cardiogenic shock. The incidence of non-insertion of the device and fracture of the flexible drive cable limited its utility, however. In addition, some processes used in pilot production could not be adapted to volume manufacturing. A second generation device, the Sternotomy Hemopump, has been developed for insertion through the ascending aorta. Design changes include a shortened inflow cannula, higher flow hydraulics, and a more durable flexible drive cable. In addition, more efficient manufacturing processes were implemented. In a pulsatile mock loop the flow was 5.7 L/min at 100 mmHg. In vivo experiments of up to 2 weeks demonstrated a mean plasma free hemoglobin of 8.7 mg/dl, minimal valve injury, and an acceptable incidence of renal infarction. In vitro endurance demonstrated a 7 day reliability of 99.9% with a 95% confidence. A new clinical trial will evaluate the use of the Sternotomy Hemopump for nonoxygenator support during aorto-coronary artery bypass surgery.
第一代Hemopump是一种基于导管安装的动脉内轴流血泵的心室辅助装置，通过股动脉放置。血液通过经瓣膜流入插管从左心室抽出，然后泵入主动脉。临床试验已证明其在心源性休克中具有血流动力学疗效、提高生存率和低溶血率。然而，该装置未成功插入和柔性驱动电缆断裂的发生率限制了其应用。此外，试生产中使用的一些工艺无法适应批量生产。第二代装置，即胸骨切开术Hemopump，已开发用于通过升主动脉插入。设计改进包括缩短流入插管、更高流量的液压系统和更耐用的柔性驱动电缆。此外，还实施了更高效的制造工艺。在脉动模拟回路中，在100 mmHg时流量为5.7 L/分钟。长达2周的体内实验表明，平均血浆游离血红蛋白为8.7 mg/dl，瓣膜损伤最小，肾梗死发生率可接受。体外耐久性测试表明，在95%置信度下，7天的可靠性为99.9%。一项新的临床试验将评估胸骨切开术Hemopump在主动脉冠状动脉搭桥手术中用于非体外循环支持的情况。
