Biocompatibility of Materials Dedicated to Non-Traumatic Surgical Instruments Correlated to the Effect of Applied Force of Working Part on the Coronary Vessel.

Abstract

Cardiovascular clamping procedures can cause tissue traumatization, leading to serious adverse events interrupting blood flow and causing life-threatening hemorrhage. The aim of the study is to evaluate the properties of 3D-printed, high-elasticity elastomeric materials-BioMed Flex 50A and 80A (Formlabs Inc., Sommerville, MA, USA)-in terms of their suitability for the fabrication of atraumatic inserts used for surgical clamping instruments. To show the importance of the elaboration of the new atraumatic materials, finite element simulations of blood vessel compression by a surgical tool were validated experimentally with porcine vessels, and histopathology assessed the tissue response. These results confirm that excessive clamping forces can cause vessel wall stratification and rupture. Specimens BioMed Flex 50A and 80A underwent surface, mechanical, and biological testing, including topography, wettability, acoustic microscopy for structural voids, cytotoxicity with human dermal fibroblasts, pro-inflammatory marker analysis, and bacterial biofilm assessment. The results of the testing of the 3D-printed BioMed Flex 50A and 80A materials show good potential for applications in safe atraumatic surgical instruments. Further research may include the possibilities to develop 3D-printed metamaterials with pressure adapting properties.