Microtextured materials for circulatory support devices: preliminary studies.

Thromboembolic events (TE) associated with circulatory support devices are a major source of mortality and morbidity. Clinically, the lowest TE rates are claimed with devices that incorporate textured blood-contacting materials. The textured materials currently used in circulatory assist devices are composed of small, attached fibers that form the boundaries of connected cavities. These cavities entrap blood components to form a "neointimal" layer, which is believed to minimize thromboembolic events. We believe that the three-dimensional surface topography of blood-contacting materials is a major controlling factor in the formation of a stable neointimal layer upon the material. Particle-cast cavities were used to form geometric features in segmented polyurethane. This microtextured material was incorporated as part of a flexible blood-contacting surface in a blood pump that was implanted as a left ventricular assist device in calves. The structure, thickness, stability, and development of the neointimal layer were then evaluated. These preliminary studies have shown that a stable neointimal layer can be formed upon the particle-cast surfaces. The results also indicate that the cavity size on the particle-cast surfaces has a significant effect on neointimal adhesion. The methods employed can be used in the design of future circulatory support devices.