Hexsyn is the Goodyear Tire and Rubber Company tradename for a polyolefin rubber synthesized from 1-hexene with 3-5% methylhexadiene as the source of residual double bonds for vulcanization. Under license from Goodyear, this same polymer has been manufactured by Lord Corporation for the hinge portion of finger joint prostheses using the tradename Bion. This rubber is currently licensed to the University of Akron and to the Cleveland Clinic Foundation for use in biomedical applications, and is being used primarily for biocompatible and highly fatigue resistant rubber components in ventricular assist and artificial heart systems. Results are presented from the physical, mechanical, and biological characterization of Hexsyn. Procedures are described for the synthesis, compounding, and post-molding extraction for Hexsyn. The physical testing of Hexsyn reported includes determinations of its density at 23 and 37 degrees C, initial hardness and hardness after aging in oxygen, blood, pseudoextracellular fluid and polyethylene glycol 600, typical molecular weights determined by gel permeation chromatography/low angle laser light scattering and intrinsic viscosity, thermal analyses by differential scanning calorimetry of Hexsyn gum, and vulcanized Hexsyn after exposure to blood and blood/fatigue conditions. Also reported are results of differential thermal analyses, thermomechanical analyses of virgin and annealed samples, and thermogravimetric analyses conducted in helium and in air. Dynamic mechanical analyses of Hexsyn include Clash-Berg and Rheovibron tests. Swelling was conducted to determine lot-to-lot and sheet-to-sheet variation for quality control and also a number of solvents were used so that the polymer-solvent interaction parameters could be determined. The permeability of Hexsyn to water, water vapor, and a variety of gases is reported. The permeability by contact angle measurements, refractive index, residual solvent analyses, migration of blood components into Hexsyn, melt rheology by Monsanto Rheometer, resistance to acids, and typical mold shrinkage for Hexsyn are reported. Mechanical testing of Hexsyn includes tensile strength, elongation, and tensile stress (modulus) at 23 and 37 degrees C and after conditions including exposure to blood, pseudoextracellular fluid, polyethylene glycol, oxygen, 100% relative humidity, and fatigue testing. Stress/strain calibration curves, flexural rigidity after aging in blood, tension set, compression set, stress relaxation, and the effect of repeated cycling on the elastic modulus are presented along with the results of Pico abrasion, skid resistance tests on wet concrete.(ABSTRACT TRUNCATED AT 400 WORDS)
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