Cardiac catheters are a vital tool in medicine due to their widespread use in many minimally invasive procedures. To aid in advancing the catheter within the patient's vasculature, many catheters are coated with a lubricious hydrophilic coating (HPC). Although HPCs benefit patients, their delamination during use is a serious safety concern. Adverse health effects associated with HPC delamination include pulmonary and myocardial embolism, embolic stroke, infarction, and death. In order to improve patient outcomes, more consistent manufacturing methods and improved quality assurance techniques are needed to evaluate HPC medical devices. The present work investigates the efficacy of two novel methods to image and evaluate HPCs post‐manufacturing, relative to industry‐standard scanning electron microscopy (SEM)‐based methods. We have shown that novel evaluation approaches based on optical microscopy (OM) and optical coherence tomography (OCT) are capable of imaging HPC layers and quantifying HPC thickness, saving hours of time relative to SEM sample preparation and imaging. Additionally, the nondestructive nature of OCT avoids damage and alteration to the HPC prior to imaging, leading to more reliable HPC thickness measurements. Overall, the work demonstrated the feasibility and advantages of using OM and OCT to image and measure HPC thickness relative to industry‐standard SEM methods.

中文翻译：

---

光学显微镜和光学相干断层扫描作为评估导管轴周围润滑亲水涂层的质量保证方法的比较。

心脏导管是医学中的重要工具，因为它们广泛用于许多微创手术。为了帮助在患者的脉管系统内推进导管，许多导管都涂有润滑的亲水涂层 (HPC)。尽管 HPC 使患者受益，但它们在使用过程中的分层是一个严重的安全问题。与 HPC 分层相关的不良健康影响包括肺和心肌栓塞、栓塞性中风、梗塞和死亡。为了改善患者的治疗效果，需要更一致的制造方法和改进的质量保证技术来评估 HPC 医疗设备。目前的工作研究了两种新方法对制造后的 HPC 成像和评估的功效，相对于基于行业标准的扫描电子显微镜 (SEM) 方法。我们已经证明，基于光学显微镜 (OM) 和光学相干断层扫描 (OCT) 的新型评估方法能够对 HPC 层进行成像并量化 HPC 厚度，相对于 SEM 样品制备和成像节省了数小时的时间。此外，OCT 的非破坏性可避免在成像之前损坏和改变 HPC，从而实现更可靠的 HPC 厚度测量。总的来说，这项工作证明了使用 OM 和 OCT 成像和测量 HPC 厚度相对于行业标准 SEM 方法的可行性和优势。OCT 的非破坏性可避免在成像之前损坏和改变 HPC，从而实现更可靠的 HPC 厚度测量。总的来说，这项工作证明了使用 OM 和 OCT 成像和测量 HPC 厚度相对于行业标准 SEM 方法的可行性和优势。OCT 的非破坏性可避免在成像之前损坏和改变 HPC，从而实现更可靠的 HPC 厚度测量。总的来说，这项工作证明了使用 OM 和 OCT 成像和测量 HPC 厚度相对于行业标准 SEM 方法的可行性和优势。