Coating Layer Inspection for Drug-Coated Balloon Catheter Uniformity
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Solution Overview
Problem
Existing methods for evaluating the condition of drug-containing coating layers on balloon catheters, such as drug eluting balloons, lack the accuracy needed to assess uniformity and distribution, which is crucial for preventing restenosis and ensuring effective drug delivery.
Innovation Solution
A coating layer inspection device and method that utilizes image processing to evaluate the coating layer's defectiveness by converting image data to grayscale, calculating average gray levels, and applying multiple threshold and upper-limit determinations to assess the uniformity and distribution of the coating layer, ensuring accurate identification of acceptable and rejectable qualities.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a drug-containing coating layer is formed on a balloon surface, then the effectiveness of drug delivery to prevent restenosis is improved, but the uniformity and distribution of the coating layer become difficult to evaluate accurately
Solution Approach 1:
The patent applies colorimetric analysis to evaluate the coating layer. By capturing images of the coating layer and converting them to grayscale, the system quantifies the distribution and uniformity of the coating based on optical density variations. This allows accurate non-contact measurement of coating properties without affecting drug delivery effectiveness.
Solution Approach 2:
The patent replaces manual visual inspection with an automated image processing system. The system uses digital image capture, grayscale conversion, and algorithmic analysis to objectively evaluate coating uniformity, replacing subjective human assessment with precise computational measurement.
2Ease of operation
If existing image processing methods are used to evaluate coating layers, then the inspection process is simplified, but the accuracy of defectiveness evaluation is insufficient
Solution Approach 1:
The patent segments the image processing into distinct stages: image capture, grayscale conversion, thresholding, and quantitative analysis. This segmentation maintains operational simplicity while enabling precise evaluation through systematic processing of different image characteristics at each stage.
Solution Approach 2:
The patent introduces grayscale conversion as an intermediary step between color image capture and defect analysis. This intermediary transformation enables the system to evaluate coating uniformity through optical density while maintaining the simplicity of digital image processing workflows.
3Measurement precision
If multiple determination criteria are applied to classify coating quality, then the accuracy of quality classification is improved, but the complexity of the inspection system increases
Solution Approach 1:
The patent uses multiple threshold values and determination criteria that operate on different parameter ranges. By establishing hierarchical thresholds (first threshold, second threshold, upper limits), the system achieves accurate multi-level classification while maintaining clear decision logic that does not significantly increase system complexity.
Data Source
AI summary
A coating layer inspection device and a method for inspecting a coating layer are disclosed that enable highly accurate evaluation of defectiveness in a coating layer of a subject. The coating layer inspection device includes a processing unit including a digitization unit that digitizes gray level information of each pixel, an average gray level calculation unit that calculates an average gray level, a first grayscale determination unit that determines whether the average gray level is equal to or greater than a first threshold and classifies the grayscale image as a potentially acceptable quality when obtaining an affirmative result, and a first upper-limit determination unit that determines whether the number of pixels having a gray level equal to or greater than the first threshold is equal to or less than a first specified upper limit and classifies the grayscale image as a potentially acceptable quality when obtaining an affirmative result.