Relationship between arterial thrombosis and neutralization of a polyethylene ionomer.

Abstract

The influence of three levels of sodium neutralization of an ethylene/methacrylic acid copolymer on in vivo blood compatibility was studied in a canine arterial model. Effects due to sample fabrication methods (thermal pressing versus solution casting) were also monitored. Sodium content, sodium release, hydrogen dissociation, and localization of anionic groups were noted. Polymer surface energy, surface morphology, water uptake, and thermal properties were characterized. Material characterization and in vivo implantation disclose the following: 1) Thermal pressing generated oxidation degradation products that decreased in vivo blood compatibility. Solution-cast samples adhered and activated fewer blood elements. 2) Platelets and leukocytes were sensitive to differences in shear rate in the carotid and femoral arteries, with the femoral site tending toward higher shear, more platelet deposition and fewer leukocytes. 3) The surface properties of the polyethylene control, 0% Na, and 50% Na samples tended to be similar. These properties were different from the 100% Na sample. The 100% Na ionomer was more hydrophilic, had a higher polar component for its surface energy, and was unique in exhibiting discrete ionic clusters 1-10 microns in diameter on its surface. 4) These differences were manifested in vivo by platelet activation and thrombus development on the polyethylene, 0% Na, and 50% Na implants, while the 100% Na implant surfaces were predominantly covered by singly adherent, unactivated platelets. 5) It is proposed that the improvement in biocompatibility for the 100% Na ionomer is due to the cluster development in the neutralized methacrylic component and that either directly, or through appropriate protein adsorption and/or conformational adjustment to the cluster regions, platelets are not activated and do not initiate the coagulation mechanism.