The applicability of parylene C as an encapsulation material for implanted neural prostheses was characterized and optimized. The adhesion of parylene C was tested on different substrate materials, which were commonly used in neural prostheses and the efficiency of different adhesion promotion methods was investigated. On Si(3)N(4), platinum, and on a first film of parylene C, a satisfactory adhesion was achieved with Silane A-174, which even withstood standard steam sterilization. The adhesion to gold and polyimide could not be improved sufficiently with the tested methods. Furthermore, tensile tests and measurements of the degree of crystallinity were performed on untreated, on steam sterilized, and on annealed parylene C layers to investigate the influence of thermal treatment. This led to more brittle and stiffer films due to an increase in the crystalline portion in the parylene layers. Finally, an electrochemical impedance spectroscopy was used to test if a parylene C layer was able to protect a metallic structure against corrosion on a Si(3)N(4) substrate. The results indicated that this could be only possible by treating the substrate with Silane A-174. To receive parylene C layers with a good encapsulation performance, it is important to consider the materials, which are used in the neural prosthesis, to find the best suited process parameters.
Parylene C is one of the established encapsulation polymers for chronic implants. We investigated the influence of annealing Parylene C on its mechanical properties, chemical structure, and on the stability of Parylene C - platinum - Parylene C sandwich structures as a model of flexible neural interfaces in 0.9 % saline solution. Films of Parylene C were annealed at 200 °C, 300 °C, 350 °C, and 400 °C in nitrogen atmosphere. Temperatures of 350 °C and higher as well as annealing in air destroyed the Parylene C layers; films annealed at lower temperatures showed identical infrared spectra. Higher anneal temperatures produced increased values of elongation at break, tensile and yield strength, and yield strain while at the same time Young's modulus was shown to decrease. Crystallinity increased with annealing temperature. The structural stability of sandwich structures benefitted remarkably from annealing. Sandwich structures annealed at 300 °C maintained their structural integrity during 320 days in saline solution at 37 °C and the insulation capability stayed consistently high.
Delamination of thin film polymeric coatings from metallization layers is a common cause of failure in biomedical implants. To address the problem, different adhesion promotion techniques can be applied which include surface pre-treatment with oxygen and argon plasma and the use of different adhesion promoters. In this paper the applicability of titanium (Ti), silicon oxide (SiOx), diamond-like carbon (DLC), tetramethylsilane (TMS) and aluminium oxide (AlOx) as adhesion promoters is evaluated. A cross cut, peel and scratch test are used to qualify and quantify the adhesion before and after storage in phosphate buffered saline (PBS) for 48 hours at a temperature of 37 °C. Promising results could be achieved by a combination of Ti and DLC as well as by AlOx.
We present a principle for monitoring of the electrical properties of polymers used as insulators for electrically active implants. This method can be used for measurements in vitro and in vivo with incomplex instrumentation. The system is based on the detuning of an oscillating circuit with an interdigital electrode (IDE) structure serving as a capacitive and resistive sensor within the oscillator. This circuit is powered via an inductive link from an external coil. The phase of the external coil's impedance is used to determine the resonance frequency and quality factor of the sensing part wirelessly. The research objective is to obtain detailed information about processes at the metal/polymer interface such as a change of the capacity due to altering of the dielectric constant (i.e. uptake of water vapor or condensation of water) and lowering of the quality factor because of leakage currents. With this information it is possible to detect if the encapsulation is stable, if degradation and loss of adhesion occurs, and if the metal corrodes. The method can be used to evaluate the long term stability of materials and technologies in vitro. The future application is to monitor the stability of implant encapsulations in situ to predict failures before they occur.
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