Objective We focus on improving the long-term stability and functionality of neural interfaces for chronic implantation by using bilayer encapsulation. Approach We evaluated the long-term reliability of Utah electrode array (UEA) based neural interfaces encapsulated by 52 nm of atomic layer deposited (ALD) Al2O3 and 6 μm of Parylene C bilayer, and compared these to devices with the baseline Parylene-only encapsulation. Three variants of arrays including wired, wireless, and active UEAs were used to evaluate this bilayer encapsulation scheme, and were immersed in phosphate buffered saline (PBS) at 57 °C for accelerated lifetime testing. Main results The median tip impedance of the bilayer encapsulated wired UEAs increased from 60 kΩ to 160 kΩ during the 960 days of equivalent soak testing at 37 °C, the opposite trend as typically observed for Parylene encapsulated devices. The loss of the iridium oxide tip metallization and etching of the silicon tip in PBS solution contributed to the increase of impedance. The lifetime of fully integrated wireless UEAs was also tested using accelerated lifetime measurement techniques. The bilayer coated devices had stable power-up frequencies at ~910 MHz and constant RF signal strength of -50 dBm during up to 1044 days (still under testing) of equivalent soaking time at 37 °C. This is a significant improvement over the lifetime of ~ 100 days achieved with Parylene-only encapsulation at 37 °C. The preliminary samples of bilayer coated active UEAs with a flip-chip bonded ASIC chip had a steady current draw of ~ 3 mA during 228 days of soak testing at 37 °C. An increase in current draw has been consistently correlated to device failures, so is a sensitive metric for their lifetime. Significance The trends of increasing electrode impedance of wired devices and performance stability of wireless and active devices support the significantly greater encapsulation performance of this bilayer encapsulation compared with Parylene-only encapsulation. The bilayer encapsulation should significantly improve the in vivo lifetime of neural interfaces for chronic implantation.

The lifetime of neural interfaces is a critical challenge for chronic implantations, as therapeutic devices (e.g., neural prosthetics) will require decades of lifetime. We evaluated the lifetime of wireless Utah electrode array (UEA) based neural interfaces with a bilayer encapsulation scheme utilizing a combination of alumina deposited by Atomic Layer Deposition (ALD) and parylene C. Wireless integrated neural interfaces (INIs), equipped with recording version 9 (INI-R9) ASIC chips, were used to monitor the encapsulation performance through radio-frequency (RF) power and telemetry. The wireless devices were encapsulated with 52 nm of ALD Al2O3 and 6 μm of parylene C, and tested by soaking in phosphate buffered solution (PBS) at 57 °C for 4× accelerated lifetime testing. The INIs were also powered continuously through 2.765 MHz inductive power and forward telemetry link at unregulated 5 V. The bilayer encapsulated INIs were fully functional for ∼35 days (140 days at 37 °C equivalent) with consistent power-up frequencies (∼910 MHz), stable RF signal (∼-75 dBm), and 100 % command reception rate. This is ∼10 times of equivalent lifetime of INIs with parylene-only encapsulation (13 days) under same power condition at 37 °C. The bilayer coated INIs without continuous powering lasted over 1860 equivalent days (still working) at 37 °C. Those results suggest that bias stress is a significant factor to accelerate the failure of the encapsulated devices. The INIs failed completely within 5 days of the initial frequency shift of RF signal at 57 °C, which implied that the RF frequency shift is an early indicator of encapsulation/device failure.

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We observed encapsulation failure modes and behaviors comparable to neural electrode performance which were undetected in studies with planar test devices. We found the impact of parylene C defects to be exacerbated by ALD AlO, and conclude that inferior bilayer performance arises from degradation of ALD AlO when directly exposed to saline. This is an important consideration, given that neural electrodes with bilayer coatings are expected to have ALD AlO exposed at dielectric boundaries that delineate electrode sites. Process improvements and use of different inorganic coatings to decrease dissolution in physiological fluids may improve performance. Testing frameworks which take neural electrode complexities into account will be well suited to reliably evaluate such encapsulation schemes.