Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices
For 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 coun...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
De Gruyter
2019-09-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2019-0052 |
| _version_ | 1811246869264728064 |
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| author | Kurzhals Anja Brandt-Wunderlich Christoph Grabow Niels Schmidt Wolfram Schmitz Klaus-Peter |
| author_facet | Kurzhals Anja Brandt-Wunderlich Christoph Grabow Niels Schmidt Wolfram Schmitz Klaus-Peter |
| author_sort | Kurzhals Anja |
| collection | DOAJ |
| description | For 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. |
| first_indexed | 2024-04-12T14:59:37Z |
| format | Article |
| id | doaj.art-0e69b66d2d3b4fd8a55d2457e7bdd0f3 |
| institution | Directory Open Access Journal |
| issn | 2364-5504 |
| language | English |
| last_indexed | 2024-04-12T14:59:37Z |
| publishDate | 2019-09-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj.art-0e69b66d2d3b4fd8a55d2457e7bdd0f32022-12-22T03:28:06ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042019-09-015120320610.1515/cdbme-2019-0052cdbme-2019-0052Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devicesKurzhals Anja0Brandt-Wunderlich Christoph1Grabow Niels2Schmidt Wolfram3Schmitz Klaus-Peter4Institute for Biomedical Engineering, Rostock University Medical Center,Rostock-Warnemuende, GermanyInstitute for ImplantTechnology and Biomaterials e.V.,Rostock-Warnemuende, GermanyInstitute for Biomedical Engineering, Rostock University Medical Center,Rostock-Warnemuende, GermanyInstitute for Biomedical Engineering, Rostock University Medical Center,Rostock-Warnemuende, GermanyInstitute for ImplantTechnology and Biomaterials e.V. and Institute for Biomedical Engineering, Rostock University Medical Center,Rostock-Warnemuende, GermanyFor 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.https://doi.org/10.1515/cdbme-2019-0052particle analysiscardiovascular implantsdynamic image analysishydrophilic coating |
| spellingShingle | Kurzhals Anja Brandt-Wunderlich Christoph Grabow Niels Schmidt Wolfram Schmitz Klaus-Peter Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices Current Directions in Biomedical Engineering particle analysis cardiovascular implants dynamic image analysis hydrophilic coating |
| title | Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| title_full | Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| title_fullStr | Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| title_full_unstemmed | Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| title_short | Dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| title_sort | dynamic image analysis of transparent particles released during the simulated use test of cardiovascular devices |
| topic | particle analysis cardiovascular implants dynamic image analysis hydrophilic coating |
| url | https://doi.org/10.1515/cdbme-2019-0052 |
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