Dynamic in vitro hemocompatibility testing – improving the signal to noise ratio

Abstract

Assigning the hemocompatibility of small vascular implants is one of the great challenges in biomedical engineering. Due to the fact, that there are no widely approved test setups1, we decided to developed a modified CHANDLER-Loop system for dynamic in vitro hemocompatibility tests. The setup allows simultaneous testing of about 30 tube rings with an inner diameter of 2,4 mm. Cardiovascular implants can be placed into these tube rings. After filling them with anticoagulated blood and closing them to loops, they were placed on a rotating disc. While the loop is rotating, the blood remains in the lower part of the loop. The relative movement between the foreign surface and the blood sample induces a blood flow without the need of mechanical pumping. A first test series with the new test setup had been conducted to achieve a highly hemocompatible tube material. The results were compared to hemocompatibility tests done by LEMM, mentioned in the ISO 10993-42,3. We could prove, that Tygon S50HL® and Polyurethane achieve similar hemocompatibility values. In addition, we did in vitro tests of bare metal stents. We recorded a difference in the index of thrombocytes of about 17 % between the loops with three stents and the control. During further experiments the difference decreases to 8 %, which might be due to adhesion processes. The ability to measure these processes demonstrates the high sensitivity and very low background activation of the test setup. This can be assured by the recorded index of hemolysis, which had been less than 0,8 % in all our experiments. By developing and improving our modified CHANDLER-Loop system, we were able to establish a dynamic in vitro test setup for the hemocompatibility testing of small vascular implants. Because of its extremely low background activation and a high variability, the system serves as a benchmark for upcoming test setups.