Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, OH 44195, USA.
Artif Organs. 2010 Dec;34(12):1158-63. doi: 10.1111/j.1525-1594.2009.00985.x.
The purpose of this study was to evaluate in vivo the biocompatibility of BioMedFlex (BMF), a new resilient, hard-carbon, thin-film coating, as a blood journal bearing material in Cleveland Heart's (Charlotte, NC, USA) continuous-flow right and left ventricular assist devices (RVADs and LVADs). BMF was applied to RVAD rotating assemblies or both rotating and stator assemblies in three chronic bovine studies. In one case, an LVAD with a BMF-coated stator was also implanted. Cases 1 and 3 were electively terminated at 18 and 29 days, respectively, with average measured pump flows of 4.9 L/min (RVAD) in Case 1 and 5.7 L/min (RVAD) plus 5.7 L/min (LVAD) in Case 3. Case 2 was terminated prematurely after 9 days because of sepsis. The sepsis, combined with running the pump at minimum speed (2000 rpm), presented a worst-case biocompatibility challenge. Postexplant evaluation of the blood-contacting journal bearing surfaces showed no biologic deposition in any of the four pumps. Thrombus inside the RVAD inlet cannula in Case 3 is believed to be the origin of a nonadherent thrombus wrapped around one of the primary impeller blades. In conclusion, we demonstrated that BMF coatings can provide good biocompatibility in the journal bearing for ventricular assist devices.
本研究旨在评估 BioMedFlex（BMF）作为克利夫兰心脏公司（美国北卡罗来纳州夏洛特）的连续流右心室辅助装置（RVAD）和左心室辅助装置（LVAD）的血液轴承材料的体内生物相容性。BMF 被应用于三个慢性牛研究中的 RVAD 旋转组件或旋转和定子组件。在一种情况下，还植入了带有 BMF 涂层定子的 LVAD。案例 1 和 3 分别在第 18 天和第 29 天被选择性终止，平均测量的泵流量分别为 4.9 L/min（RVAD）和 5.7 L/min（RVAD）加 5.7 L/min（LVAD）。案例 2 在 9 天后因败血症而提前终止。败血症，加上以最低速度（2000 rpm）运行泵，带来了最坏情况下的生物相容性挑战。对四个泵中的血液接触轴颈轴承表面的离体评估显示，没有任何生物沉积。案例 3 中的 RVAD 入口套管内的血栓被认为是一个不附着的血栓缠绕在一个主要叶轮叶片之一的起源。总之，我们证明了 BMF 涂层可以在心室辅助装置的轴颈轴承中提供良好的生物相容性。
