This paper was accepted for publication after the 1995 Conference of the European Society of Biomaterials, Oporto, Portugal, 10 —13 September. * Author to whom correspondence should be addressed. JOURNAL OF MATERIALS SCIENCE: MATERIALS IN MEDICINE 8 (1997) 119 — 129 Dynamic blood cell contact with biomaterials: validation of a flow chamber system according to international standards M. OTTO * , C. L. KLEIN, H. KO fi HLER, M. WAGNER, O. RO fi HRIG, C. J. KIRKPATRICK Institute of Pathology, Johannes Gutenberg-University, D-55101 Mainz, Germany The increasing number of patients requiring prosthetic substitution of segments of the vascular system strongly supports the need to optimize a relevant, standardized testing panel for new materials designed for synthetic vascular prostheses. The ISO gives the standard requirements for testing biomaterials provided for implantation. Our primary interest was the establishment of a reliable in vitro panel as a useful and relevant screening system for vascular implant devices to evaluate blood/device interactions under flow conditions. The aim of the present study was to evaluate influences of different flow conditions on blood cell—biomaterial interactions with special emphasis on the interactions of human granulocytes (PMN) and polymeric surfaces. PMN were isolated and vital cells were quantified by flow cytometrical analysis directly before, as well as immediately after the experiments. The viscosity of the final cellular suspension was analysed by using a computerized cone-plate rheometer. As reference materials we used FEP-teflon, PVC-DEHD, PU, PP and PE. Dacron and ePTFE synthetic vascular protheses were tested in a comparative way to those references. The adhesion processes were observed over a period of 40 minutes under arterial (shear stress 0.74 Pa) and venous (shear stress 0.16 Pa) flow conditions in a parallel plate flow chamber system under highly standardized conditions and laminar flow. The cells were observed with the help of inverse light microscopy. Cell behaviour was recorded and analysed in both analogue (video) and digital (imaging system) modes. Samples of the cell suspensions were obtained at regular time intervals and analysed by enzyme linked immuno sorbent assay (ELISA) to quantify LTB 4 release. Irrespective of the material, approximately 3 to 4 times more PMN adhered to the biomaterial surfaces under venous flow conditions compared to the arterial. Shear intensity did not influence the running order of biomaterials with respect to cell numbers. This response in descending order at the end of the experiments was as follows: PU, PVC-DEHD, PP, PE and ePTFE. The biochemical analyses indicate that in the system used only a weak effect on LTB 4 release induced by the different materials could be determined. A significant effect caused by flow conditions was not observed. Further experiments, both static as well as dynamic, must be performed for multiple, relevant parameters of haemocompatibility, for potential biomaterials as well as those currently in use in vascular prostheses. 1. Introduction Vascular diseases are the major cause of mortality and morbidity in technologically and economically de- veloped countries. Hypertension, coronary artery dis- ease, cerebrovascular and peripheral vascular diseases, as well as venous thromboembolism give a higher annual lethality than all other diseases together [1]. As a result of this situation an increasing number of patients are coming to operation for substitution of parts of their vascular system. In the last few years the development and testing of potential biomaterials for vascular grafts have focused on the need for standard- ized methods which are relevant for their application. In order to establish a commonly accepted method of test procedures for biomaterials the International Standard Organisation (ISO) inaugurated the ISO 10993 directive [2]. Part 4: ‘‘Selection of tests for interaction with blood’’ and part 5: ‘‘Testing cytotoxicity’’ presented guidelines on flexibly designed testing panels for the evaluation of biomaterials. The 119 0957—4530 ( 1997 Chapman & Hall