Department of Neurological Surgery, University of Wisconsin, Madison, WI 53792, USA.
J Neural Eng. 2012 Apr;9(2):026009. doi: 10.1088/1741-2560/9/2/026009. Epub 2012 Feb 14.
Convection-enhanced delivery (CED) is an advanced infusion technique used to deliver therapeutic agents into the brain. CED has shown promise in recent clinical trials. Independent verification of published parameters is warranted with benchmark testing of published parameters in applicable models such as gel phantoms, ex vivo tissue and in vivo non-human animal models to effectively inform planned and future clinical therapies. In the current study, specific performance characteristics of two CED infusion catheter systems, such as backflow, infusion cloud morphology, volume of distribution (mm(3)) versus the infused volume (mm(3)) (Vd/Vi) ratios, rate of infusion (µl min(-1)) and pressure (mmHg), were examined to ensure published performance standards for the ERG valve-tip (VT) catheter. We tested the hypothesis that the ERG VT catheter with an infusion protocol of a steady 1 µl min(-1) functionality is comparable to the newly FDA approved MRI Interventions Smart Flow (SF) catheter with the UCSF infusion protocol in an agarose gel model. In the gel phantom models, no significant difference was found in performance parameters between the VT and SF catheter. We report, for the first time, such benchmark characteristics in CED between these two otherwise similar single-end port VT with stylet and end-port non-stylet infusion systems. Results of the current study in agarose gel models suggest that the performance of the VT catheter is comparable to the SF catheter and warrants further investigation as a tool in the armamentarium of CED techniques for eventual clinical use and application.
经颅超声溶栓（CET）是一种将治疗剂递送至大脑的高级输注技术。CET 在最近的临床试验中显示出了前景。需要通过在适用的模型（如凝胶模型、离体组织和体内非人类动物模型）中对已发表参数进行基准测试，对已发表参数进行独立验证，以便为计划中的和未来的临床治疗提供有效的信息。在目前的研究中，检查了两种 CED 输注导管系统的特定性能特征，如回流、输注云形态、分布体积（mm(3)）与输注体积（mm(3)）（Vd/Vi）比、输注速度（µl min(-1)）和压力（mmHg），以确保 ERG 阀尖（VT）导管的已发表性能标准。我们假设，以 1 µl min(-1)的稳定输注速度的 ERG VT 导管的功能与最近获得 FDA 批准的 MRI 介入 SmartFlow（SF）导管与 UCSF 输注方案在琼脂糖凝胶模型中是可比的。在凝胶模型中，VT 和 SF 导管之间的性能参数没有显著差异。我们首次报告了这两种类似的单端口 VT 带导丝和端口非导丝输注系统之间 CED 中的基准特征。目前在琼脂糖凝胶模型中的研究结果表明，VT 导管的性能与 SF 导管相当，值得进一步研究，作为 CED 技术的工具，最终用于临床应用。
