Abstract
Hemocompatibility of blood-contacting biomaterials is one of the most important criteria for their successful in vivo applicability. Thus, extensive in vitro analyses according to ISO 10993-4 are required prior to clinical applications. In this review, we summarize essential aspects regarding the evaluation of the hemocompatibility of biomaterials and the required in vitro analyses for determining the blood compatibility. Static, agitated, or shear flow models are used to perform hemocompatibility studies. Before and after the incubation of the test material with fresh human blood, hemolysis, cell counts, and the activation of platelets, leukocytes, coagulation and complement system are analyzed. Furthermore, the surface of biomaterials are evaluated concerning attachment of blood cells, adsorption of proteins, and generation of thrombus and fibrin networks.
Highlights
Hemocompatibility is one of the major criteria, which limit the clinical applicability of bloodcontacting biomaterials
The initially adsorbed protein layer on the biomaterial surface mainly triggers the adverse reactions, such as the activation of coagulation via intrinsic pathway, the activation of leukocytes, which results in inflammation, and the adhesion and activation of platelets (Liu et al, 2014)
These immune cells are belonging to the innate immune system and they can be rapidly activated upon recognition of Hemocompatibility of Blood-Contacting Biomaterials a foreign invader such as a pathogen or a foreign material
Summary
Hemocompatibility is one of the major criteria, which limit the clinical applicability of bloodcontacting biomaterials These materials come in close contact with blood, which is a complex “organ,” comprising of 55% plasma, 44% erythrocytes, and 1% leukocytes and platelets. Monocytes account for 1–6% of all leukocytes and neutrophil granulocytes are the most abundant leukocytes in the blood, comprising 50–70% of all leukocytes These immune cells are belonging to the innate immune system and they can be rapidly activated upon recognition of. Guidewires, dialyzer, oxygenators (artificial lungs), heart-supporting systems, cardiac pacemaker, vascular grafts, stents, heart valves, micro-, and nanoparticles are widely used medical devices and materials coming in direct contact with blood. The hemocompatibility of blood-contacting medical materials have to be analyzed and a guidance is developed by the International Organization for Standardization (ISO 10993-4) (International Organization for Standardization, 2000). Before and after the incubation of biomaterials with fresh human blood, the activation markers regarding hemocompatibility are analyzed (Figure 1)
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