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A New Hemodynamic Ex Vivo Model for Medical Devices Assessment
- Source :
- Annals of Vascular Surgery, Annals of Vascular Surgery, Elsevier Masson, 2015, 29 (8), pp.1648-1655. ⟨10.1016/j.avsg.2015.06.066⟩, Annals of Vascular Surgery, 2015, 29 (8), pp.1648-1655. ⟨10.1016/j.avsg.2015.06.066⟩
- Publication Year :
- 2015
- Publisher :
- HAL CCSD, 2015.
-
Abstract
- Introduction: In stent restenosis (ISR) remains a major public health concern with an increased morbidity, mortality and health-related costs. Drug-eluting stents (DES) have reduced ISR, but are associated with healing-related issues or hypersensitivity reactions, leading to an increased risk of late acute stent thrombosis. Evaluations of new DES are based on animal models or in vitro release systems which show several limitations. The role of flow and shear stress on endothelial cell and ISR has also been emphasized. The aim of this work was to design and first evaluate an original bioreactor, reproducing ex vivo hemodynamic and biological conditions similar to human conditions, to further evaluate new DES. Methods & Results: This bioreactor was designed to study up to 6 stented arteries connected in bypass, immersed in a culture box, in which circulated a physiological systolo-diastolic resistive flow. Two centrifugal pumps drove the flow. The principal pump generated pulsating flows by modulation of rotation velocity, and the second pump worked at constant rotation velocity, ensuring the counter pressure levels and backflows. The flow rate, the velocity profile, the arterial pressure and the resistance of the flow were adjustable. The bioreactor was placed in an incubator to reproduce a biological environment. A first experience of feasibility was realized over a period of 24 days. Three rat aortic thoracic arteries were placed into the bioreactor, immersed in cell culture medium change every 3 days, and with a circulating systole diastolic flux circulating among the entire experimentation. There was no infection, no leak. At the end of experimentation, a morphometric analysis was performed confirming the viability of the arteries. Conclusion: We design and patent an original hemodynamic ex vivo model to further study new DES and ISR. We will next validate this ex vivo model of ISR reproducing this experimentation with stented arteries. Once validated, this bioreactor will allow characterization of the velocity field and drug transfers within a stented artery with new functionalized DES, with experimental means not available in vivo. Another main point will be the reduction of animal experimentation, and the availability of first results of new DES in human tissues (human infra popliteal or coronary arteries collected during human donation).
- Subjects :
- Leak
medicine.medical_specialty
Hemodynamics
030204 cardiovascular system & hematology
Prosthesis Design
Models, Biological
[SPI.MECA.MEFL]Engineering Sciences [physics]/Mechanics [physics.med-ph]/Fluids mechanics [physics.class-ph]
03 medical and health sciences
Bioreactors
0302 clinical medicine
Restenosis
medicine.artery
Materials Testing
medicine
Animals
Humans
030212 general & internal medicine
Aorta
business.industry
Drug-Eluting Stents
General Medicine
medicine.disease
equipment and supplies
Rats
3. Good health
Surgery
Coronary arteries
medicine.anatomical_structure
Blood pressure
Vascular resistance
Vascular Resistance
Shear Strength
Cardiology and Cardiovascular Medicine
business
Mécanique: Mécanique des fluides [Sciences de l'ingénieur]
Ex vivo
Biomedical engineering
Subjects
Details
- Language :
- English
- ISSN :
- 08905096 and 16155947
- Database :
- OpenAIRE
- Journal :
- Annals of Vascular Surgery, Annals of Vascular Surgery, Elsevier Masson, 2015, 29 (8), pp.1648-1655. ⟨10.1016/j.avsg.2015.06.066⟩, Annals of Vascular Surgery, 2015, 29 (8), pp.1648-1655. ⟨10.1016/j.avsg.2015.06.066⟩
- Accession number :
- edsair.doi.dedup.....ee6d8822dcd1f18f21ed244b035f8ef4