Blueprint for a Semi-automated Image Processing Tool to Characterize Stent Features: Application to a Pediatric...

Area of Science:

• Biomedical Engineering
• Medical Device Design
• Image Processing

Background:

• Manual measurement of small, complex stent features is time-consuming and serves as the current gold standard.
• Rapid iteration and accurate assessment are crucial in medical device development.

Purpose of the Study:

• To develop a general blueprint for a semi-automated image processing tool (SIPT) for measuring stent prototypes.
• To establish SIPT as a viable replacement for manual measurements, improving efficiency and accuracy.

Main Methods:

• Stent prototypes were designed using CAD and manufactured via laser cutting.
• A SIPT algorithm was developed in MATLAB to extract and measure key stent dimensions (inner/outer diameter, spring bend radius/width).
• Measurements were compared against manual measurements by a metrology technician using statistical analyses (two one-sided test, Bland-Altman).

Main Results:

• Over 5000 unique measurements were made across 4 key dimensions for 15 stents using SIPT.
• SIPT reduced measurement time by nearly 90% and increased measurement volume by over 2300% compared to manual methods.
• Statistical analysis confirmed SIPT achieved measurement equivalency to the manual gold standard for all dimensions.

Conclusions:

• SIPT software effectively replaces manual measurements for stent prototypes, offering substantial time savings and consistent accuracy.
• The presented workflow is generalizable for isolating and measuring critical features in complex manufactured parts.
• SIPT provides a valuable, cost-effective tool for medical device designers to accelerate stent design iterations.