PulmoStent: In Vitro to In Vivo Evaluation of a Tissue Engineered Endobronchial Stent.
Currently, there is no optimal treatment available for end stage tumour patients with airway stenosis. The PulmoStent concept aims on overcoming current hurdles in airway stenting by combining a nitinol stent with a nutrient-permeable membrane, which prevents tumour ingrowth. Respiratory epithelial cells can be seeded onto the cover to restore mucociliary clearance. In this study, a novel hand-braided dog bone stent was developed, covered with a polycarbonate urethane nonwoven and mechanically tested. Design and manufacturing of stent and cover were improved in an iterative process according to predefined requirements for permeability and mechanical properties and finally tested in a proof of concept animal study in sheep for up to 24 weeks. In each animal two stents were implanted, one of which was cell-seeded by endoscopic spraying in situ. We demonstrated the suitability of this membrane for our concept by glucose transport testing and in vitro culture of respiratory epithelial cells. In the animal study, no migration occurred in any of the twelve stents. There was only mild granulation tissue formation and tissue reaction; no severe mucus plugging was observed. Thus, the PulmoStent concept might be a step forward for palliative treatment of airway stenosis with a biohybrid stent device.
Department of Biohybrid & Medical Textiles (BioTex) at AME-Helmholtz Institute for Biomedical Engineering, ITA-Institut für Textiltechnik, RWTH Aachen University and at AMIBM Maastricht University, The Netherlands, Pauwelsstr. 20, 52074, Aachen, Germany.
Anja Lena
0000-0002-2990-0761
AL
Thiebes
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Nicola
N
Kelly
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Caoimhe A
CA
Sweeney
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Donnacha J
DJ
McGrath
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Johanna
J
Clauser
Department of Biohybrid & Medical Textiles (BioTex) at AME-Helmholtz Institute for Biomedical Engineering, ITA-Institut für Textiltechnik, RWTH Aachen University and at AMIBM Maastricht University, The Netherlands, Pauwelsstr. 20, 52074, Aachen, Germany.
Kathrin
K
Kurtenbach
Department of Biohybrid & Medical Textiles (BioTex) at AME-Helmholtz Institute for Biomedical Engineering, ITA-Institut für Textiltechnik, RWTH Aachen University and at AMIBM Maastricht University, The Netherlands, Pauwelsstr. 20, 52074, Aachen, Germany.
Valentine N
VN
Gesche
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.
Weiluan
W
Chen
Department of Pharmaceutics, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Universiteitsweg 99, 3584 CG, Utrecht, The Netherlands.
Robbert Jan
RJ
Kok
Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen University, Pauwelsstr. 20, 52074, Aachen, Germany.
Ulrich
U
Steinseifer
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Mark
M
Bruzzi
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Barry J
BJ
O'Brien
Biomechanics Research Centre, Biomedical Engineering, College of Engineering and Informatics, National University of Ireland, University Road, Galway, Ireland.
Peter E
PE
McHugh
Department of Biohybrid & Medical Textiles (BioTex) at AME-Helmholtz Institute for Biomedical Engineering, ITA-Institut für Textiltechnik, RWTH Aachen University and at AMIBM Maastricht University, The Netherlands, Pauwelsstr. 20, 52074, Aachen, Germany. jockenhoevel@ame.rwth-aachen.de.
Stefan
S
Jockenhoevel
Department of Biohybrid & Medical Textiles (BioTex) at AME-Helmholtz Institute for Biomedical Engineering, ITA-Institut für Textiltechnik, RWTH Aachen University and at AMIBM Maastricht University, The Netherlands, Pauwelsstr. 20, 52074, Aachen, Germany.|Department for Internal Medicine - Section for Pneumology, Medical Faculty, RWTH Aachen University, Pauwelsstr. 30, 52074, Aachen, Germany.
Christian G
CG
Cornelissen
D000497:Alloys; D000818:Animals; D001807:Blood Vessel Prosthesis; D018929:Cell Culture Techniques; D004285:Dogs; D042783:Endothelial Cells / Q000378:metabolism*; D005260:Female; D012756:Sheep; D015607:Stents; D023822:Tissue Engineering / Q000379:methods*
D000497:Alloys; C013616:nitinol
Airway stenting; Animal trial; Stent development; Tissue engineering