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Comparison of optical microscopy and optical coherence tomography as quality assurance methods for evaluating
Alexander A Oliver1, Jonathan S Stinson2, Ashley Osborne2
1Department of Biomedical Engineering, Michigan Technological University, Houghton, Michigan.
Insights
New imaging methods, optical microscopy (OM) and optical coherence tomography (OCT), can effectively evaluate hydrophilic coating (HPC) on cardiac catheters. These techniques offer faster, non-destructive alternatives to scanning electron microscopy (SEM) for improved medical device quality assurance.
Area of Science:
- Biomedical Engineering
- Materials Science
- Medical Imaging
Background:
- Cardiac catheters utilize hydrophilic coatings (HPCs) to facilitate insertion during minimally invasive procedures.
- Delamination of HPCs presents a significant safety risk, potentially causing serious adverse health events like embolism and stroke.
- Current quality assurance methods for HPCs, primarily scanning electron microscopy (SEM), are time-consuming and destructive.
Purpose of the Study:
- To investigate novel imaging techniques for evaluating hydrophilic coatings (HPCs) on cardiac catheters.
- To compare the efficacy of optical microscopy (OM) and optical coherence tomography (OCT) against industry-standard SEM methods.
- To establish improved quality assurance techniques for HPC medical devices.
Main Methods:
- Utilized optical microscopy (OM) to image and assess hydrophilic coating (HPC) layers.
- Employed optical coherence tomography (OCT) for non-destructive imaging and thickness quantification of HPCs.
- Compared OM and OCT results with traditional scanning electron microscopy (SEM) analyses.
Main Results:
- Both OM and OCT successfully imaged HPC layers and quantified HPC thickness.
- OM and OCT methods significantly reduced evaluation time compared to SEM.
- OCT provided non-destructive measurements, preserving the integrity of the HPC for subsequent analysis.
Conclusions:
- Optical microscopy (OM) and optical coherence tomography (OCT) are feasible and advantageous methods for imaging and measuring hydrophilic coating (HPC) thickness on cardiac catheters.
- These novel techniques offer a faster and more reliable alternative to SEM for quality assurance of HPC medical devices.
- Implementing OM and OCT can enhance patient safety by ensuring consistent manufacturing and quality of cardiac catheters.
Abstract:
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.
