scholarly journals Systematic morphological characterization of sub-visible particles generated from cardiovascular devices using dynamic image analysis

2021 ◽  
Vol 7 (2) ◽  
pp. 617-620
Author(s):  
Anja Kurzhals ◽  
Christoph Brandt-Wunderlich ◽  
Klaus-Peter Schmitz ◽  
Niels Grabow ◽  
Wolfram Schmidt

Abstract The assessment of particulate matter generated during a simulated use is requested by international standards for approval of cardiovascular devices. The particle suspension was generated during a simulated use test procedure of a commercially available coronary stent delivery system and analyzed by Dynamic image analysis (DIA) using FlowCAM 8000. Four parameters were analyzed: the diameter, the aspect ratio value, the circularity and the intensity. The results revealed that 53% of the particles were larger than 25 μm. The particle shapes were inhomogeneous with a wide ranging aspect ratio of 0.03 to 0.95. Around 83% had an intensity value of more than 140 grey scales and appeared translucent.

2019 ◽  
Vol 34 (4) ◽  
pp. 89-95
Author(s):  
Saman Tabrizi-Zarringhabaei ◽  
◽  
Reza Goli Ejlali ◽  
Mikaeil Yousefzadeh Fard ◽  
Sayyedjavad Sayyedfattahi ◽  
...  

2019 ◽  
Vol 5 (1) ◽  
pp. 203-206
Author(s):  
Anja Kurzhals ◽  
Christoph Brandt-Wunderlich ◽  
Niels Grabow ◽  
Wolfram Schmidt ◽  
Klaus-Peter Schmitz

AbstractFor product approval of coated cardiovascular devices, the assessment of particle release is essential. Particularly challenging are delivery systems equipped with hydrophilic coatings releasing highly transparent particles. The aim of this study was to compare two different methods of particle counting, namely the light obscuration method and the dynamic image analysis (DIA), with respect to optical transparent particles. The particles were collected during the simulated use of cardiovascular catheters and analysed in suspension with a dynamic imaging device (FlowCam, Fluid Imaging Technologies). Particles were detected by a greyscale threshold and imaged to analyse their shape and transparency. The statistical influence of the threshold on particle counts and size distribution was determined and compared to light obscuration particle counting (Model 9703 with sensor HRLD 400CE, HIAC ROYCO). The light obscuration method provided lower particle counts in suspensions containing a high amount of transparent particles. The lower the detection threshold, the higher the particle counts were. In conclusion, it is important to adapt the threshold value for samples that are expected to contain a high amount of transparent particles. DIA may be suggested as a valuable additional method for particulate analysis.


2006 ◽  
Vol 23 (2) ◽  
pp. 145-153 ◽  
Author(s):  
Hans Saveyn ◽  
Tran Le Thu ◽  
Ruxandra Govoreanu ◽  
Paul Van der Meeren ◽  
Peter A. Vanrolleghem

2013 ◽  
Vol 19 (S2) ◽  
pp. 800-801
Author(s):  
P. Bajaj ◽  
C. Strom

Extended abstract of a paper presented at Microscopy and Microanalysis 2013 in Indianapolis, Indiana, USA, August 4 – August 8, 2013.


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