ABSTRACT
The goal of this work was to develop a general blueprint for a semi-automated image processing tool (SIPT) to measure small, complex features of stent prototypes that can replace the current gold standard of manual measurements. The stents were designed using CAD software and manufactured via laser cutting. Stent prototypes were imaged using a Keyence microscope in top and side view orientations. The SIPT algorithm was developed in MATLAB to extract and measure 4 dimensions of the stent (inner and outer diameter, spring bend outer radius, spring bend width). The same dimensions were also manually measured by an experienced metrology technician as a gold standard comparison. We successfully made over 5000 unique measurements across the 4 key dimensions of 15 stents using the SIPT algorithm. Compared to the gold standard manual method, SIPT reduced measurement time by nearly 90% and increased the total number of measurements captured by over 2300%. The two one-sided test and Bland-Altman analysis demonstrated that SIPT achieved equivalency against the manual method of measurement for all 4 dimensions. In summary, we found that our SIPT software could be used to replace manual measurements and provided substantial time savings with consistent accuracy. Overall, this paper presents a generalizable workflow to isolate and measure critical features of stent prototypes that we believe will provide a valuable, cost-effective tool to other medical device designers seeking to rapidly iterate on unique stent designs or other manufactured parts with small and complex structures.
ABSTRACT
Characterization of cardiovascular tissue geometry and mechanical properties of large animal models is essential when developing cardiovascular devices such as heart valve replacements. These datasets are especially critical when designing devices for pediatric patient populations, as there is often limited data for guidance. Here, we present a previously unavailable dataset capturing anatomical measurements and mechanical properties of juvenile Yorkshire (YO) and Yucatan (YU) porcine main pulmonary artery (PA) and pulmonary valve (PV) tissue regions that will inform pediatric heart valve design requirements for preclinical animal studies. In addition, we developed a novel radial balloon catheter-based method to measure tissue stiffness and validated it against a traditional uniaxial tensile testing method. YU piglets, which were significantly lower weight than YO counterparts despite similar age, had smaller PA and PV diameters (7.6-9.9 mm vs. 10.1-12.8 mm). Young's modulus (stiffness) was measured for the PA and the PV region using both the radial and uniaxial testing methods. There was no significant difference between the two breeds for Young's modulus measured in the elastic (YU PA 84.7 ± 37.3 kPa, YO PA 79.3 ± 15.7 kPa) and fibrous regimes (YU PA 308.6 ± 59.4 kPa, YO PA 355.7 ± 68.9 kPa) of the stress-strain curves. The two testing techniques also produced similar stiffness measurements for the PA and PV region, although PV data showed greater variation between techniques. Overall, YU and YO piglets had similar PA and PV diameters and tissue stiffness to previously reported infant pediatric patients. These results provide a previously unavailable age-specific juvenile porcine tissue geometry and stiffness dataset critical to the development of pediatric cardiovascular prostheses. Additionally, the data demonstrates the efficacy of a novel balloon catheter-based technique that could be adapted to non-destructively measure tissue stiffness in situ.
