Evaluation of a Bioabsorbable Self-Expandable Vein Stent-Base Made of Poly(l-lactide) In Vitro and In Vivo
- Purdue University, Weldon School of Biomedical Engineering (United States)
- Cook Research Incorporated (United States)
- Institut für Radiologie, Kantonsspital Winterthur (Switzerland)
- William Cook Europe (Denmark)
PurposeThis study was designed to evaluate performance and tissue response to a self-expandable bioabsorbable vein stent-base cut from a tube with enhanced stiffness and strength in vitro and in vivo.MethodsA diamond-shaped stent-base was cut from a sequential biaxially strained poly(l-lactide) (PLLA) tube for optimized performance. The performance of the stent-base was evaluated in a finite element analysis model, and validation was attempted in vitro through a cyclic flat-plate compression and radial force measurement. The performance of the stent-base was tested in vivo using 3 sheep with 2 implants each for 2 and 3½ weeks, respectively.ResultsIn vitro the stent-base showed an elliptical deformation but no fractures. In vivo the stent-base showed adequate radial force and no migration. All implanted stent-bases showed multiple fractures not only at the predicted stress zones but at all connecting points. Fragments of the caudal stent-base stayed in the vein wall indicating sufficient tissue coverage to avoid embolization of the fractured stent pieces, whereas fragments from the cranial device remaining were few. Neointima formation was confirmed histologically at 2 and 3½ weeks.ConclusionA bioabsorbable self-expandable stent-base made from PLLA for large veins seems feasible, but over time, the PLLA used in this study appears too stiff and lacks the sufficient flexibility to move with the vena cava, causing multiple fractures.
- OSTI ID:
- 22645352
- Journal Information:
- Cardiovascular and Interventional Radiology, Vol. 40, Issue 1; Conference: BSIR 2016: Britisch Society of Interventional Radiology 2016 annual meeting, Manchester (United Kingdom), 15-17 Nov 2016; Other Information: Copyright (c) 2017 Springer Science+Business Media New York and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE); http://www.springer-ny.com; Country of input: International Atomic Energy Agency (IAEA); ISSN 0174-1551
- Country of Publication:
- United States
- Language:
- English
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