Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents
Magnesium metal (Mg) is a promising material for stent applications due to its biocompatibility and ability to be resorbed by the body. Manufacturing of stents by laser cutting has become an industry standard. Our alternative approach uses photo-chemical etching to transfer a pattern of the stent on...
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| Format: | Article |
| Language: | English |
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KeAi Communications Co., Ltd.
2021-06-01
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| Series: | Bioactive Materials |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2452199X20303030 |
| _version_ | 1797203574808117248 |
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| author | Bala Subramanya Pavan Kumar Kandala Guangqi Zhang Capucine LCorriveau Mark Paquin Madeleine Chagnon Dana Begun Vesselin Shanov |
| author_facet | Bala Subramanya Pavan Kumar Kandala Guangqi Zhang Capucine LCorriveau Mark Paquin Madeleine Chagnon Dana Begun Vesselin Shanov |
| author_sort | Bala Subramanya Pavan Kumar Kandala |
| collection | DOAJ |
| description | Magnesium metal (Mg) is a promising material for stent applications due to its biocompatibility and ability to be resorbed by the body. Manufacturing of stents by laser cutting has become an industry standard. Our alternative approach uses photo-chemical etching to transfer a pattern of the stent onto a Mg sheet. In this study, we present three stages of creating and validating a stent prototype, which includes design and simulation using finite element analysis (FEA), followed by fabrication based on AZ31 alloy and, finally, in vivo testing in peripheral arteries of domestic pigs. Due to the preliminary character of this study, only six stents were implanted in two domestic farm pigs weighing 25–28 kg and they were evaluated after 28 days, with an interim follow-up on day 14. The left and right superficial femoral, the left iliac, and the right renal artery were selected for this study. The diameters of the stented artery segments were evaluated at the time of implantation, on day 14 and then, finally, on day 28, by quantitative vessel analysis (QVA) using fluoroscopic imaging. Optical Coherence Tomography (OCT) imaging displayed some malposition, breaks, stacking, and protrusion into the lumen at the proximal, distal, and mid-sections of the stented arteries. The stents degraded with time, but simultaneously became embedded in the intima. After 28 days, the animals were euthanized, and explanted vessels were fixed for micro-CT imaging and histology studies. Micro-CT imaging revealed stent morphological and volumetric changes due to the in-body degradation. An in vivo corrosion rate of 0.75 mm/year was obtained by the CT evaluation. The histology suggested no-life threatening effects, although moderate injury, inflammation, and endothelialization scores were observed. |
| first_indexed | 2024-04-24T08:21:30Z |
| format | Article |
| id | doaj.art-78e56a28b84b4877b2b5f99201229600 |
| institution | Directory Open Access Journal |
| issn | 2452-199X |
| language | English |
| last_indexed | 2024-04-24T08:21:30Z |
| publishDate | 2021-06-01 |
| publisher | KeAi Communications Co., Ltd. |
| record_format | Article |
| series | Bioactive Materials |
| spelling | doaj.art-78e56a28b84b4877b2b5f992012296002024-04-17T00:55:04ZengKeAi Communications Co., Ltd.Bioactive Materials2452-199X2021-06-016616631675Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stentsBala Subramanya Pavan Kumar Kandala0Guangqi Zhang1Capucine LCorriveau2Mark Paquin3Madeleine Chagnon4Dana Begun5Vesselin Shanov6Department of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USADepartment of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USACharles River Laboratories Montreal ULC, Boisbriand, Quebec, J7H 1N8, CanadaMedical Products Market Consulting, Inc, Indianapolis, IN, 46202, USACharles River Laboratories Montreal ULC, Boisbriand, Quebec, J7H 1N8, CanadaWaygate Technologies, Baker Hughes, Cincinnati, OH, 45241, USADepartment of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USA; Department of Chemical and Environmental Engineering, University of Cincinnati, OH, 45221, USA; Corresponding author. Department of Mechanical and Materials Engineering, University of Cincinnati, OH, 45221, USA.Magnesium metal (Mg) is a promising material for stent applications due to its biocompatibility and ability to be resorbed by the body. Manufacturing of stents by laser cutting has become an industry standard. Our alternative approach uses photo-chemical etching to transfer a pattern of the stent onto a Mg sheet. In this study, we present three stages of creating and validating a stent prototype, which includes design and simulation using finite element analysis (FEA), followed by fabrication based on AZ31 alloy and, finally, in vivo testing in peripheral arteries of domestic pigs. Due to the preliminary character of this study, only six stents were implanted in two domestic farm pigs weighing 25–28 kg and they were evaluated after 28 days, with an interim follow-up on day 14. The left and right superficial femoral, the left iliac, and the right renal artery were selected for this study. The diameters of the stented artery segments were evaluated at the time of implantation, on day 14 and then, finally, on day 28, by quantitative vessel analysis (QVA) using fluoroscopic imaging. Optical Coherence Tomography (OCT) imaging displayed some malposition, breaks, stacking, and protrusion into the lumen at the proximal, distal, and mid-sections of the stented arteries. The stents degraded with time, but simultaneously became embedded in the intima. After 28 days, the animals were euthanized, and explanted vessels were fixed for micro-CT imaging and histology studies. Micro-CT imaging revealed stent morphological and volumetric changes due to the in-body degradation. An in vivo corrosion rate of 0.75 mm/year was obtained by the CT evaluation. The histology suggested no-life threatening effects, although moderate injury, inflammation, and endothelialization scores were observed.http://www.sciencedirect.com/science/article/pii/S2452199X20303030Magnesium alloyFEA modellingStentsPhoto-chemically etchingMicro-CTHistology |
| spellingShingle | Bala Subramanya Pavan Kumar Kandala Guangqi Zhang Capucine LCorriveau Mark Paquin Madeleine Chagnon Dana Begun Vesselin Shanov Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents Bioactive Materials Magnesium alloy FEA modelling Stents Photo-chemically etching Micro-CT Histology |
| title | Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents |
| title_full | Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents |
| title_fullStr | Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents |
| title_full_unstemmed | Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents |
| title_short | Preliminary study on modelling, fabrication by photo-chemical etching and in vivo testing of biodegradable magnesium AZ31 stents |
| title_sort | preliminary study on modelling fabrication by photo chemical etching and in vivo testing of biodegradable magnesium az31 stents |
| topic | Magnesium alloy FEA modelling Stents Photo-chemically etching Micro-CT Histology |
| url | http://www.sciencedirect.com/science/article/pii/S2452199X20303030 |
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