In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices.

In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices.
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用于心室辅助装置的新型弹性硬碳薄膜涂层的体内生物相容性评估。

DOI:
10.1111/j.1525-1594.2009.00985.x
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发表时间:
2010
期刊:
影响因子:
2.4
通讯作者:
Fukamachi,Kiyotaka
Fukamachi,Kiyotaka
中科院分区:
工程技术3区
文献类型:
--
作者:
Takaseya,Tohru;Fumoto,Hideyuki;Shiose,Akira;Arakawa,Yoko;Rao,Santosh;Horvath,DavidJ;Massiello,AlexL;Mielke,Nicole;Chen,Ji-Feng;Zhou,Qun;Dessoffy,Raymond;Kramer,Larry;Benefit,Stephen;Golding,LeonardAR;Fukamachi,Kiyotaka

文献摘要

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本研究的目的是评估新型弹性硬碳薄膜涂层BioMedFlex(BMF)作为克利夫兰心脏(美国北卡罗来纳州夏洛特)连续流右、左心室辅助装置(RVADs和LVADs)的血液日记承载材料的体内生物相容性。在三项长期的牛研究中,BMF被应用于RVAD旋转组件或同时应用于旋转和定子组件。在一个案例中,还植入了带有BMF涂层定子的LVAD。例1和例3分别于18d和29d择期终止,例1的平均泵流量为4.9min L/分钟(RVAD),例3的平均泵流量为5.7min L/分钟(RVAD)加5.7 的L/分钟(  )。例2因脓毒症在9d后提前终止。败血症,再加上泵以最低速度(2000 rpm)运行,构成了最糟糕的生物相容性挑战。植入后对接触血液的轴颈轴承表面的评估显示,四个泵中的任何一个都没有生物沉积。病例3中RVAD入口插管内的血栓被认为是缠绕在主叶轮叶片上的未粘连血栓的来源。综上所述,我们证明了BMF涂层可以为心脏辅助装置的轴颈轴承提供良好的生物相容性。
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.