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A novel Parylene C-based peripheral nerve interface that combines both electrodes and microfluidic channels in an adjustable cuff was designed, fabricated, and characterized. This minimally invasive interface incorporates a drug delivery system for targeted delivery of lysing agents and neurotrophic factors to the nerve surface to locally disrupt the epineurium and allow fascicular selectivity. Multiple platinum (Pt) electrodes were embedded in the microfluidic channels for neural stimulation and recording. The lyse-and-attract cuff electrode (LACE) uses a simple locking mechanism that is adjustable for close contact with nerves of varying diameters. Devices were fabricated using standard Parylene microfabrication techniques resulting in low variability and high device yield. A procedure for the implantation of the LACE was developed and successfully demonstrated in vivo around rat sciatic nerves. The adjustable locking mechanism demonstrated adequate holding strength and fit around the nerves. Benchtop electrochemical characterization of the thin-film Pt electrodes showed that the electrodes possessed high charge storage capacity (>1 mC/cm2) and low impedances ($< 2~\text{k}\Omega $ at 1 kHz) suitable for neural stimulation and recording. As expected, embedded electrodes demonstrated higher impedance values. Acute neural recording from the rat sciatic nerve verified the capability of the LACE to record evoked neural activity (compound action potentials). Controlled and localized microfluidic infusions were achieved at low flow rates ($< 1~\mu \text{L}$ /min). Finally, infusion experiments in vivo demonstrated targeted drug delivery to the sciatic nerve fascicles. This multifunctional peripheral nerve interface has the potential to enhance implant-tissue integration in vivo and provide reliable chronic performance not available in the existing extraneural or intraneural interfaces. [2018-0192] [ABSTRACT FROM AUTHOR]

Parylene C is a promising material for constructing flexible, biocompatible and corrosionresistant microelectromechanical systems (MEMS) devices. Historically, Parylene C has been employed as an encapsulation material for medical implants, such as stents and pacemakers, due to its strong barrier properties and biocompatibility. In the past few decades, the adaptation of planar microfabrication processes to thin film Parylene C has encouraged its use as an insulator, structural and substrate material for MEMS and other microelectronic devices. However, Parylene C presents unique challenges during microfabrication and during use with liquids, especially for flexible, thin film electronic devices. In particular, the flexibility and low thermal budget of Parylene C require modification of the fabrication techniques inherited from silicon MEMS, and poor adhesion at Parylene-Parylene and Parylene-metal interfaces causes device failure under prolonged use in wet environments. Here, we discuss in detail the promises and challenges inherent to Parylene C and present our experience in developing thin-film Parylene MEMS devices. [ABSTRACT FROM AUTHOR]

Recent advances in the micromachining of poly(p-xylylenes), commercially known as Parylenes, have enabled the development of novel structures and devices for microelectromechanical systems (MEMS). In particular, Parylene C (poly[chloro-p-xylylene]) has been explored extensively for biomedical applications of MEMS given its compatibility with micromachining processes, proven biocompatibility, and many advantageous properties including its chemical inertness, optical transparency, flexibility, and mechanical strength. Here we present a review of often used and recently developed micromachining process for Parylene C, as well as a high-level overview of state-of-the-art Parylene hybrid and free film devices for biomedical MEMS (bioMEMS) applications, including a discussion on its challenges and potential as a MEMS material. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

A novel pressure transducer concept is introduced in which external pressure variations induce changes in the volume of a trapped microbubble ( \mu \textB ) in an electrolyte solution. These volumetric changes are monitored by electrochemical impedance-based measurements and may be used for pressure tracking applications. Microbubbles are nucleated on-demand by electrolysis within a confinement chamber with high precision (measured size RSD $\sim 1$ %). This pressure transducer concept was developed specifically for operation in liquid environments and features biocompatible construction, small footprint (<0.1 mm2), and low power consumption (<1 nW). This combination of features is ideal for in vivo pressure monitoring applications. [2015-0203] [ABSTRACT FROM PUBLISHER]

To investigate the mechanical interactions between the implanted cortical multielectrode probes and brain tissue, a Parylene C-based electrochemical-microelectromechanical systems force sensor array was developed. The array consists of seven linearly distributed sensor units arranged along the length of a flexible Parylene C microchannel. The seven sensor units are formed by eight fluidically coupled and adjacent platinum electrode pairs enclosed within the microchannel. Deformation of the top surface of the mechanically compliant microchannel changes the volumetric conduction path between the pairs of sensing electrodes, and therefore, the measured electrochemical impedance, which is proportional to the magnitude of the contacting force. Each sensor unit demonstrated a linear response from 0 to 60 mN with a sensitivity of 0.13 ± 0.01 percentage change in impedance/ \mu \textN (%/ \mu \textN ; mean ± SE, n = 6 ). The sensor arrays were mounted onto a ceramic intracortical probe and inserted into the tissue phantoms to verify in situ functionality and assess interfacial probe mechanics. Probe surface force distribution was measured under various insertion speeds and the results indicated that interfacial forces are distributed nonuniformly along the probe shaft length, concentrating within the first 1 mm of the advancing probe tip. Faster insertion speeds were also found to decrease the magnitude of the interfacial forces, suggesting that the tissue strain during cortical implantation may be minimized through appropriate selection of the insertion speed.[2014-0320] [ABSTRACT FROM PUBLISHER]

We present high-efficiency Nafion-coated electrochemical actuators having biocompatible construction suitable for biomedical applications such as drug delivery. High flow rates of up to 141.95 \pm 0.46\ \mu\L/min were achieved (at 13 mA). Nafion coating increased efficiency across all current values tested and prevented current-induced damage to electrodes. The effects of coating thickness, electroplating, actuator orientation, and changes in temperature on actuator performance were studied. Electrochemical impedance spectroscopy is introduced as a tool for characterizing electrodes, quality of electrochemical cleaning, determining surface area activity, and also for understanding the impact of electrolyte coatings, electroplating, and substrate changes on actuator performance. Parylene and polyetheretherketone (PEEK) were investigated as flexible substrate substitutes for soda lime glass. The higher surface roughness of the PEEK substrate compared to glass led to actuators with improved flow rates.\hfill[2011-0361] [ABSTRACT FROM AUTHOR]

We report on the use of electrochemical impedance (EI) as the basis for force transduction in Parylene-based microdevices. Electrolyte-filled microstructures were realized for extremely sensitive contact-force detection (10 mN range, \pm0.023 mN resolution) enabled by EI-based transduction and are a promising platform for next-generation biomedical sensing technology. The design, fabrication, and characterization of Parylene-based electrochemical-MEMS (EC-MEMS) devices capable of microNewton contact-mode force measurement are presented and discussed.\hfill[2011-0040] [ABSTRACT FROM AUTHOR]

We report the design, fabrication, and characterization of electrochemical microelectromechanical systems (EC-MEMS) devices featuring encapsulated fluid as the basis for transduction. Parylene microstructures, including discrete chambers (square or circular geometry), are utilized as physical transducers for electrochemically mediated liquid impedance transduction of physical phenomenon such as contact and force. Parylene-based EC-MEMS technologies uniquely leverage advantages in size (<500\ \mu\m diameter), packaging (no hermetic packaging necessary), power (nanowatts to microwatts), and flexibility to address the physical sensing requirements of in vivo applications. Robust EC impedance (EI) sensor responses (up to 20% from base-line) and discrimination of 200-nm chamber deflections were possible using the EI transduction technique. Additional transducer configurations enabling electrolysis-based out-of-plane actuation and biomimetic mechanotransduction in microfluidic channels are also presented. \hfill[2010-0157] [ABSTRACT FROM AUTHOR]

We present a low power, on demand Parylene MEMS electrothermal valve. A novel Ω-shaped thermal resistive element requires low power (∼mW) and enables rapid valve opening (∼ms). Using both finite element analysis and valve opening experiments, a robust resistive element design for improved valve opening performance in water was obtained. In addition, a thermistor, as an inrush current limiter, was added into the valve circuit to provide variable current ramping. Wireless activation of the valve using RF inductive power transfer was demonstrated. [ABSTRACT FROM AUTHOR]

The first microelectromechanical-system normally closed electrothermal valve constructed using Parylene C is described, which enables both low power (in milliwatts) and rapid operation (in milliseconds). This low-power valve is well suited for applications in wirelessly controlled implantable drug-delivery systems. The simple design was analyzed using both theory and modeling and then characterized in benchtop experiments. Operation in air (constant current) and water (current ramping) was demonstrated. Valve-opening powers of 22 mW in air and 33 mW in water were obtained. Following integration of the valve with catheters, our valve was applied in a wirelessly operated microbolus infusion pump, and the in vivo functionality for the appropriateness of use of this pump for future brain mapping applications in small animals was demonstrated [ABSTRACT FROM AUTHOR]

Abstract: A microelectromechanical systems (MEMS) thermal flow sensing array constructed of biocompatible materials has been designed, fabricated, and tested. In addition to the construction, the electronic biasing conditions were selected such that sensor operation was compatible with biological fluids. The device comprises several thin film platinum sensing elements sandwiched in a Parylene C membrane. The membrane is suspended over a bulk-micromachined silicon channel for improved thermal isolation. This sensing array layout permits, for the first time, operation in multiple flow sensing modes using a single device. Multi-mode testing was performed in hot-film, calorimetric, and time-of-flight modes at low overheat ratios. Furthermore, constant current (CC) and constant temperature (CT) biasing methods were explored in hot-film mode. The results of the various testing modes were compared and flow sensing down to 0.5μL/min has been demonstrated. [Copyright &y& Elsevier]

Abstract: This paper presents the design, fabrication, and functional testing of a fully implantable, flexible, Parylene-enable neurostimulator that features single-channel wireless stimulation capability . This system comprises a fold-and-bond microelectromechanical systems (MEMS) coil for wireless power and data transmission, a BION 1-3 CMOS stimulator chip, discrete capacitors, as well as a carrier substrate with two platinum stimulating electrodes and interconnections for system assembly. The physical geometries of the devices are designed for use in retinal implantation with the specifications determined from the implantation results in canine eyes. The coil and carrier substrate are separately fabricated using a Parylene–metal skin technology. The unique properties of Parylene C allow these MEMS devices to be flexible and biocompatible, facilitating surgical procedure. The system assembly is achieved by interconnecting individual components together on the carrier substrate with a biocompatible silver epoxy. A 10μm layer of Parylene C is selectively deposited on the integrated system to protect it from corrosive eye environment. The system functionality is verified using a telemetry link setup, and single-phase pulses with amplitudes ranging from 7 to 8.5V are detected. [Copyright &y& Elsevier]

Abstract: A microelectromechanical systems (MEMS) drug delivery device is investigated for the treatment of incurable ocular diseases. Unlike conventional ocular drug delivery devices, this MEMS device is capable of being refilled, features electronic control of the drug regimen, and enables targeted intraocular drug delivery. The refillable design permits long-term drug therapy and avoids repetitive surgeries. Electronic control of dosing is achieved by using electrolysis-actuated pumping to deliver pharmaceuticals directly to the intraocular space. A flexible Parylene transscleral cannula allows targeted delivery to tissues in both the anterior and posterior segments of the eye. This electrochemically driven drug delivery device was demonstrated to provide flow rates suitable for ocular drug therapy (pL/min to μL/min). Both continuous and bolus drug delivery modes were performed to achieve accurate delivery of a target volume of 250nL. An encapsulation packaging technique was developed for acute surgical studies and preliminary ex vivo drug delivery experiments in porcine eyes were performed. [Copyright &y& Elsevier]