Frequency dependence of viscoelastic properties of medical grade silicones.

Cylinders of medical grade silicone elastomers, (29 mm in diameter and 13 mm thick), immersed in physiological saline solution at 37 degrees C, were investigated by dynamic mechanical analysis (DMA). A sinusoidal cyclic compression of 40 +/- 5 N was applied over a frequency range, f, of 0.02-100 Hz. Values of the storage, E', and loss, E'', moduli for the cylinders were found to depend on f; the dependence of E' or E'' on the logarithm (base 10) of f was represented by a third-order polynomial. Above about 0.3 Hz, the cylindrical specimens appeared to be undergoing the onset of a transition from the rubbery to the glassy state. There was no significant difference between results obtained at 37 and 23 degrees C; pretreatment of specimens in physiological saline at 37 degrees C for 24 h and 29 days had no appreciable effect on the results.

Accelerated aging for testing polymeric biomaterials and medical devices.

Elevated temperature is frequently used to accelerate the aging process in polymers that are associated with medical devices and other applications. A common approach is to assume that the rate of aging is increased by a factor of 2(DeltaT/10), where DeltaT is the temperature increase. This result is a mathematical expression of the empirical observation that increasing the temperature by about 10 degrees C roughly doubles the rate of many polymer reactions. It is equivalent to assuming that the aging process is a first order chemical reaction with an activation energy of 10R/log(e)2, where R is the universal gas constant. A better approach would be to determine the activation energy for the process being considered but this is not always practicable. The simple approach does not depend on the temperature increase, provided that it is not so great that it initiates any physical or chemical process that is unlikely to be involved in normal aging. If a temperature increment theta were to increase a given polymer reaction rate n times, then an elevated temperature would increase the rate of aging by a factor of n(DeltaT/theta).

The effect of the environment on the mechanical properties of medical grade silicones.

Silicone spacers have been in use as replacement joints in the human hand for over 30 years. Since they were first used there has been a number of designs all of which have had problems with fracture. This may be due to a defect in the material caused during implantation, or by bony intrusions within the arthritic hand after implantation. The aim of this research was to investigate the effect of the environment on the mechanical properties of medical grade silicones used for human implantation. The materials were subjected to static tensile testing after various forms of ageing. The environmental conditions included temperatures of 37 and 80 degrees C and the environments of Ringer's solution, distilled water, and air. The environmental conditions employed resulted in reduced mechanical strength with ageing time of the silicones. This research supports the view that failure of silicone implants in the hand could be partly attributed to the effects of environmental ageing of the material.