An In Vitro Blood Flow Loop System for Evaluating the Thrombogenicity of Medical Devices and Biomaterials.

ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs
Megan A JamiolkowskiQijin Lu

Abstract

A reliable in vitro dynamic test method to evaluate device thrombogenicity is very important for the improvement of the design and safety of blood-contacting medical devices, while reducing the use of animal studies. In this study, a recirculating flow loop system was developed for thrombogenicity testing, using donor sheep blood anticoagulated with Anticoagulant Citrate Dextrose Solution A (ACDA) and used within 24-36 hr postdraw. Immediately before testing, the blood was recalcified and heparinized to a donor-specific target concentration. The heparinization level was based on a static pretest, in which latex tubes were incubated at room temperature for 30 min in blood with a series of heparin concentrations and evaluated for thrombus deposition. For dynamic testing, blood was recirculated at room temperature through a polyvinyl chloride (PVC) tubing loop containing a test material for 1 hr at 200 ml/min using a roller pump. Nine materials were investigated: a negative control (polytetrafluoroethylene [PTFE]), a positive control (latex), and seven commonly used biomaterials including PVC, two silicones with different formulations (Q-Sil and V-Sil), nylon, polyurethane (PU), high-density polyethylene (HDPE), and polyether bloc...Continue Reading

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Citations

Sep 16, 2020·Journal of Biomedical Materials Research. Part B, Applied Biomaterials·Michael F WolfCarrie A Strief
Jan 30, 2021·ASAIO Journal : a Peer-reviewed Journal of the American Society for Artificial Internal Organs·Megan A JamiolkowskiQijin Lu
Jun 10, 2021·Journal of Biomedical Materials Research. Part B, Applied Biomaterials·Qijin LuRichard A Malinauskas
Oct 28, 2021·Artificial Organs·Qing HanDavid N Ku

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