Analysis of the Lifetime of Neural Implants Using In Vitro Test Structures

Abstract

The aim of this work was to measure the lifetime of neural implant test samples at two different temperatures, using a method that allows the precise measurement of the sample lifetime, further analysis with the use of Weibull statistics, and examination of the applicability of the Van’t Hoff rule. The correct estimation of the lifetime of neural implants is important to avoid preliminary failures, when used in humans. The novelty lies in the precise data due to the measurement approach, the application of the Weibull statistics to neural test samples, and the examination of the Van’t Hoff rule’s applicability to the longevity of polyimide-based neural implant samples. Several samples that consisted of interdigitated gold strands, encapsulated in polyimide were soaked in ringer solution. One batch was soaked at a temperature of 37 °C, and another was soaked at a temperature of 57 °C. Voltage was applied and measured to identify the occurrence of failures. The long-term experiment was stopped after 458 days for the samples at 37 °C and 423 days for the samples at 57 °C, with several samples still being intact at both temperature levels. The time to failure was measured and used to identify the Weibull parameters that would describe the behavior of the samples. The median lifetime of the samples changed from 363 days at 37 °C to 138 days at 57 °C. The scale and shape factor changed from 396 and 3.7 at 37 °C to 138 and 2 at 57 °C, respectively. The measured mean, median times, and Weibull scale factors were lower than expected from the Van’t Hoff rule. The use of the Van’t hoff rule with 2ΔT/10°C for accelerated lifetime tests would lead to an estimation of longer lifetimes than realistic. A reaction rate constant around 1.47 appears more appropriate. While a fourfold difference in lifetime would be expected, only a 2.65-fold difference in the median lifetime and a roughly 2.2-fold difference in the mean and Weibull scale factor were observed. The shift of the Weibull shape parameter from 3.7 at 37 °C to 2 at 57 °C with rising temperatures was observed, indicating differences in failure reasons and stronger aging at lower temperatures. The used method is simple to apply and interpret and allows for a precise anticipation of sample lifetimes.

System of Implantable Electrodes for Neural Signal Acquisition and Stimulation for Wirelessly Connected Forearm Prosthesis

“…However, these changes were not very pronounced for the gold-coated needle electrodes during the immersion period, as also observed in other studies that investigated the longterm stability of gold in saline or phosphate solutions [43,44]. Determining the frequency of 1 kHz in vitro tests for implantable electrodes is important for evaluating their electrochemical behavior and tissue interaction, ensuring measurement stability, and achieving comparability of data across different studies and research [45,46]. The impedance at 1 kHz (Figure 14c(I,II)) remained unchanged after 21 days of immersion of gold-coated needles in saline solution at body temperature and after ultrasound treatments.…”