Blood Contacting Components
REM has worked with critical, blood-contacting medical device components and implants for over twenty years. We understand that blood flowing through and contacting these devices experiences a high flow velocity and turbulence such that sharp edges or high surface roughness can result in hemolysis. Further, we know that surface roughness and non-optimal surface textures such as those generated by machining operations can increase the risk of thrombosis. For life-critical devices and implants, these risks must be mitigated by an appropriate surface finishing process.
REM’s ISF® Process is a chemically accelerated isotropic superfinishing process that is ideally suited to process critical, blood-contacting components to achieve the optimum edge radius and surface finish while preserving critical geometries. This unique superfinishing/polishing technology creates a non-directional isotropic surface texture with extremely low surface roughness values (Ra < 2 µin/0.05 µm) which has been shown to reduce the risk of both hemolysis and device thrombosis as well as increase cleanliness, sterility, and resistance to corrosion including fretting. The process is fully automated and machined controlled, eliminating costly manual processes such as hand polishing, and it is extremely controllable, capable of delivering material removal accuracy of +/- 0.00005 inches (~1.25 µm). Unlike “black box technologies”, the ISF Process is fully auditable and available as both an outsourced service and an installed process depending on customer needs.
The significant advantages generated by the ISF® Surface relative to the prevention of thrombogenic and hemolytic effects, the reduction in component fatigue/wear and bacterial proliferation, and the increases to corrosion resistance are linked to both the unique isotropic surface texture and the chemical-mechanical nature of the process. REM’s ISF® Technology has been applied to over 35,000 FAA approved, destination therapy, life-critical left ventricle assist devices (LVAD), effectively increasing biocompatibility and patient experience.
Some of the Many Benefits of the ISF Process for Blood Contacting Devices:
- Reduced Hemolysis
- Reduced Thrombosis
- Increased Corrosion Resistance
- Improved Sterility/ Reduced Bacterial Proliferation
- Improved Biocompatibility
- Reduced Component Fatigue/Reduce Wear
- Optimal Edge Radius Generation
Working on a new medical device or blood-contacting component design or have a need to improve the performance of an existing device/component? Contact us for more information or to start a project. REM is ready to support your needs from initial design consultation for surface finishing to full stage production.