Xianzong Xie

Long-term reliability of Al2O3?and Parylene C bilayer encapsulated Utah electrode array based neural interfaces for chronic implantation

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 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 to 160 kΩ during the 960 days of equivalent soak testing at 37 °C, the opposite trend to that 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 radio-frequency 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 the 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.

Plasma-assisted atomic layer deposition of Al2O3 and parylene C bi-layer encapsulation for chronic implantable electronics

Encapsulation of biomedical implants with complex three dimensional geometries is one of the greatest challenges achieving long-term functionality and stability. This report presents an encapsulation scheme that combines Al(2)O(3) by atomic layer deposition with parylene C for implantable electronic systems. The Al(2)O(3)-parylene C bi-layer was used to encapsulate interdigitated electrodes, which were tested invitro by soak testing in phosphate buffered saline solution at body temperature (37 °C) and elevated temperatures (57 °C and 67 °C) for accelerated lifetime testing up to 5 months. Leakage current and electrochemical impedance spectroscopy were measured for evaluating the integrity and insulation performance of the coating. Leakage current was stably about 15 pA at 5 V dc, and impedance was constantly about 3.5 MΩ at 1 kHz by using electrochemical impedance spectroscopy for samples under 67 °C about 5 months (approximately equivalent to 40 months at 37 °C). Alumina and parylene coating lasted at least 3 times longer than parylene coated samples tested at 80 °C. The excellent insulation performance of the encapsulation shows its potential usefulness for chronic implants.

Long-Term Bilayer Encapsulation Performance of Atomic Layer Deposited Al

We present an encapsulation scheme that combines atomic layer deposited (ALD) Al2O3 and Parylene C for the encapsulation of implantable devices. The encapsulation performances of combining alumina and Parylene C was compared to individual layers of Parylene C or alumina and the bilayer coating had superior encapsulation properties. The alumina-Parylene coated interdigitated electrodes (IDEs) soaked in PBS for up to nine months at temperatures from 37 to 80 °C for accelerated lifetime testing. For 52-nm alumina and 6-μm Parylene C, leakage current was ~20 pA at 5 VDC, and the impedance was about 3.5 MΩ at 1 kHz with a phase near -87° from electrochemical impedance spectroscopy for samples soaked at 67 °C for equivalent lifetime of 72 months at 37 °C. The change of impedance during the whole soaking period (up to 70 months of equivalent soaking time at 37 °C) over 1 to 10 6 Hz was within 5%. The stability of impedance indicated almost no degradation of the encapsulation. Bias voltage effect was studied by continuously applying 5 VDC, and it reduced the lifetime of Parylene coating by ~75% while it showed no measurable effect on the bilayer coating. Lifetime of encapsulation of IDEs with topography generated by attaching a coil and surface mount device (SMD) capacitor was about half of that of planer IDEs. The stable long-term insulation impedance, low leakage current, and better lifetime under bias voltage and topography made this double-layer encapsulation very promising for chronic implantable devices.

_{\bf 2}

The lifetime and stability of insulation are critical features for the reliable operation of an implantable neural interface device. A critical factor for an implanted insulations performance is its barrier properties that limit access of biological fluids to the underlying device or metal electrode. Parylene C is a material that has been used in FDA-approved implantable devices. Considered a biocompatible polymer with barrier properties, it has been used as a substrate, insulation or an encapsulation for neural implant technology. Recently, it has been suggested that a bilayer coating of Parylene C on top of atomic-layer-deposited Al2O3 would provide enhanced barrier properties. Here we report a comprehensive study to examine the mean time to failure of Parylene C and Al2O3-Parylene C coated devices using accelerated lifetime testing. Samples were tested at 60°C for up to 3 months while performing electrochemical measurements to characterize the integrity of the insulation. The mean time to failure for Al2O3-Parylene C was 4.6 times longer than Parylene C coated samples. In addition, based on modeling of the data using electrical circuit equivalents, we show here that there are two main modes of failure. Our results suggest that failure of the insulating layer is due to pore formation or blistering as well as thinning of the coating over time. The enhanced barrier properties of the bilayer Al2O3-Parylene C over Parylene C makes it a promising candidate as an encapsulating neural interface.

O

With the rapid development of micro systems technology and microelectronics, smart implantable wireless electronic systems are emerging for the continuous surveillance of relevant parameters in the body and even for closed-loop systems with a sensor feed-back to drug release systems. With respect to diabetes management, there is a critical societal need for a fully integrated sensor array that can be used to continuously measure a patient’s blood glucose concentration, pH, pCO2 and colloid oncotic pressure twenty four hours a day on a long-term basis. In this work, thin films of metabolite-specific or “smart” hydrogels were combined with microfabricated piezoresistive pressure transducers to obtain “chemomechanical sensors” that can serve as selective and versatile wireless biomedical sensors and sensor arrays for a continuous monitoring of several metabolites. Sensor response time and accuracy with which sensors can track gradual changes in glucose, pH, CO2 and ionic strength, respectively, was estimated in vitro using simulated physiological solutions. The biocompatibility and hermeticity of the developed multilayer encapsulation for the microsensor array has been investigated concerning the long-term stability and enduring functionality that is desired for permanent implants.

_{\bf 3}

The recently developed alumina and Parylene C bi-layer encapsulation improved the lifetime of neural interfaces. Tip deinsulation of Utah electrode array based neural interfaces is challenging due to the complex 3D geometries and high aspect ratios of the devices. A three-step self-aligned process was developed for tip deinsulation of bilayer encapsulated arrays. The deinsulation process utilizes laser ablation to remove Parylene C, O2 reactive ion etching to remove carbon and Parylene residues, and buffered oxide etch to remove alumina deposited by atomic layer deposition, and expose the IrOx tip metallization. The deinsulated iridium oxide area was characterized by scanning electron microscopy, atomic force microscopy, X-ray photoelectron spectroscopy, and electrochemical impedance spectroscopy to determine the morphology, surface morphology, composition, and electrical properties of the deposited layers and deinsulated tips. The alumina layer was found to prevent the formation of micro cracks on iridium oxide during the laser ablation process, which has been previously reported as a challenge for laser deinsulation of Parylene films. The charge injection capacity, charge storage capacity, and impedance of deinsulated iridium oxide were characterized to determine the deinsulation efficacy compared to Parylene-only insulation. Deinsulated iridium oxide with bilayer encapsulation had higher charge injection capacity (240 vs 320 nC) and similar electrochemical impedance (2.5 vs 2.5 kΩ) compared to deinsulated iridium oxide with only Parylene coating for an area of 2 × 10-4 cm2. Tip impedances were in the ranges of 20 to 50 kΩ, with median of 32 KΩ and standard deviation of 30 kΩ, showing the effectiveness of the self-aligned deinsulation process for alumina and Parylene C bi-layer encapsulation. The relatively uniform tip impedance values demonstrated the consistency of tip exposures.

and Parylene C for Biomedical Implantable Devices

We assess the performance of a parylene C - aluminum oxide bilayer encapsulation strategy as it applies to implantable devices with non-planar topography. Electrochemical measurements of devices subject to in vitro accelerated lifetime testing are analyzed to evaluate benefits of bilayer encapsulation versus parylene C alone. Failure modes associated with device features and topographies are identified and solutions are presented that promote stability of device impedances.