Damien C. Rodger

Microfabricated Implantable Parylene-Based Wireless Passive Intraocular Pressure Sensors

This paper presents an implantable parylene-based wireless pressure sensor for biomedical pressure sensing applications specifically designed for continuous intraocular pressure (IOP) monitoring in glaucoma patients. It has an electrical LC tank resonant circuit formed by an integrated capacitor and an inductor coil to facilitate passive wireless sensing using an external interrogating coil connected to a readout unit. Two surface-micromachined sensor designs incorporating variable capacitor and variable capacitor/inductor resonant circuits have been implemented to realize the pressure-sensitive components. The sensor is monolithically microfabricated by exploiting parylene as a biocompatible structural material in a suitable form factor for minimally invasive intraocular implantation. Pressure responses of the microsensor have been characterized to demonstrate its high pressure sensitivity ( > 7000 ppm/mmHg) in both sensor designs, which confirms the feasibility of pressure sensing with smaller than 1 mmHg of resolution for practical biomedical applications. A six-month animal study verifies the in vivo bioefficacy and biostability of the implant in the intraocular environment with no surgical or postoperative complications. Preliminary ex vivo experimental results verify the IOP sensing feasibility of such device. This sensor will ultimately be implanted at the pars plana or on the iris of the eye to fulfill continuous, convenient, direct, and faithful IOP monitoring.[2008-0111].

Wafer-Level Parylene Packaging With Integrated RF Electronics for Wireless Retinal Prostheses

This paper presents an embedded chip integration technology that incorporates silicon housings and flexible Parylene-based microelectromechanical systems (MEMS) devices. Accelerated-lifetime soak testing is performed in saline at elevated temperatures to study the packaging performance of Parylene C thin films. Experimental results show that the silicon chip under test is well protected by Parylene, and the lifetime of Parylene-coated metal at body temperature (37°C) is more than 60 years, indicating that Parylene C is an excellent structural and packaging material for biomedical applications. To demonstrate the proposed packaging technology, a flexible MEMS radio-frequency (RF) coil has been integrated with an RF identification (RFID) circuit die. The coil has an inductance of 16 μH with two layers of metal completely encapsulated in Parylene C, which is microfabricated using a Parylene-metal-Parylene thin-film technology. The chip is a commercially available read-only RFID chip with a typical operating frequency of 125 kHz. The functionality of the embedded chip has been tested using an RFID reader module in both air and saline, demonstrating successful power and data transmission through the MEMS coil.

Surface-Micromachined Parylene Dual Valves for On-Chip Unpowered Microflow Regulation

This paper presents the worlds first surface-micromachined parylene dual-valved microfluidic system for on-chip unpowered microflow regulation. Incorporating a normally closed and a normally open passive check valve in a back-to-back configuration inside a microchannel, the dual-valved system has successfully regulated the pressure/flow rate of air and liquid without power consumption or electronic/magnetic/thermal transduction. By exclusively using parylene C (poly-para-xylylene C) as the structural material, the fabricated valves have higher flexibility to shunt flows in comparison to other conventional thin-film valves. A state-of-the-art multilayer polymer surface-micromachining technology is applied here to fabricate parylene microvalves of various designs. The parylene-based devices are completely biocompatible/implantable and provide an economical paradigm for fluidic control in integrated lab-on-a-chip systems. Design, fabrication, and characterization of the parylene dual valves are discussed in this paper. Testing results have successfully demonstrated that the microflow regulation of the on-chip dual-valved system can achieve a bandpass profile in which the pressure control range is 0-50 mmHg with corresponding flow rates up to 2 mL/min for air flow and 1 muL/min flow rate for water flow. This regulation range is suitable for controlling biological conditions in human health care, with potential applications including drug delivery and regulation of elevated intraocular pressure (IOP) in glaucoma patients

Robust parylene-to-silicon mechanical anchoring

This paper describes a new technique for strongly anchoring parylene (poly-para-xylylene) layers on a silicon substrate. Parylene has gained interest for MEMS applications due to its excellent properties. More specifically, because of its flexibility (Youngs modulus of 4 GPa), its chemical barrier properties, its conformal deposition and its biocompatibility, parylene is of great interest for microfluidics and BioMEMS. One of the issues with parylene processing is adhesion and delamination problems, occurring during fabrication or during device operation. Here, we report a new technique for anchoring parylene films on silicon using DRIE-etched trenches and anchors. We demonstrate a new way to completely protect the adhesion of parylene even when exposed to aggressive chemicals.

Implantable micromechanical parylene-based pressure sensors for unpowered intraocular pressure sensing

This paper presents the first implantable, unpowered, parylene-based microelectromechanical system (MEMS) pressure sensor for intraocular pressure (IOP) sensing. From in situ mechanical deformation of the compliant spiral-tube structures, this sensor registers pressure variations without electrical or powered signal transduction of any kind. Micromachined high-aspect-ratio polymeric hollow tubes with different geometric layouts are implemented to obtain high-sensitivity pressure responses. An integrated device packaging method has been developed toward enabling minimally invasive suture-less needle-based implantation of the device. Both in vitro and ex vivo device characterizations have successfully demonstrated mmHg resolution of the pressure responses. In vivo animal experiments have also been conducted to verify the biocompatibility and functionality of the implant fixation method inside the eye. Using the proposed implantation scheme, the pressure response of the implant can be directly observed from outside the eye under visible light, with the goal of realizing convenient, direct and faithful IOP monitoring in glaucoma patients.

Microelectronic packaging for retinal prostheses

An innovative parylene-based high-density chip-level integrated interconnect (CL-I/sup 2/) packaging system for retinal implants id discussed. The implications of this CL-I/sup 2/ technology for retinal prosthesis packaging effort are far-reaching. This technology obviates the need for a technician to create electrical and mechanical connections one by one. Instead, the technology is limited only by standard photolithography and standard microfabrication techniques, providing the capability for a reduction of an order of magnitude or more in the center-to-center pad distances that can be accommodated in the process. High-density electrode arrays are thereby feasible, because the fabrication process places no limit on the number of output pads that can reasonably be connected to the array.

Implantable parylene-based wireless intraocular pressure sensor

This paper presents a novel implantable, wireless, passive pressure sensor for ophthalmic applications. Two sensor designs incorporating surface-micromachined variable capacitor and variable capacitor/inductor are implemented to realize the pressure sensitive components. The sensor is monolithically microfabricated using parylene as a biocompatible structural material in a suitable form factor for increased ease of intraocular implantation. Pressure responses of the microsensor are characterized on-chip to demonstrate its high pressure sensitivity (> 7000 ppm/mmHg) with mmHg level resolution. An in vivo animal study verifies the biostability of the sensor implant in the intraocular environment after more than 150 days. This sensor will ultimately be implanted at the pars plana or iris of the eye to fulfill continuous intraocular pressure (IOP) monitoring in glaucoma patients.

Corrosion Behavior of Parylene-Metal-Parylene Thin Films in Saline

In this paper, we study the corrosion behavior of parylene-metalparylene thin films using accelerated-lifetime soak tests. The samples under test are thin film resistors with a 200 nm layer of Au sandwiched by parylene-C on both sides, fabricated with parylenemetal skin technology. The samples are tested in hot saline both passively and actively, and different failure modes are observed using optical and electron-beam metrologies. Bubbles and delamination are first seen in the samples after 2 days of soaking under passive conditions, and followed by metal corrosion. While under active conditions, either bubbles or parylene breakdowns are observed depending on the thickness of parylene packaging. These results contribute to a better understanding of the failure mechanisms of parylene packaging in body fluids.

High-Density Flexible Parylene-Based Multielectrode Arrays for Retinal and Spinal Cord Stimulation

Novel flexible parylene-based high-density electrode arrays have been developed for functional electrical stimulation in retinal and spinal cord applications. These electrode arrays are microfabricated according to single-metal-layer and, most recently, dual-metal-layer processes. A new heat-molding process has been implemented to conform electrode arrays to approximate the curvature of canine retinas, and chronic implantation studies have been undertaken to study the mechanical effects of parylene-based prostheses on the retina, with excellent results to date. Electrode arrays have also been implanted and tested on the spinal cords of murine models, with the ultimate goal of facilitation of locomotion after spinal cord injury; these arrays provide a higher density and better spatial control of stimulation and recording than is typically possible using traditional fine-wire electrodes. Spinal cord stimulation typically elicited three muscle responses, an early (direct), a middle (monosynaptic), and a late (polysynaptic) response, classified based on latency after stimulation. Stimulation at different rostrocaudal levels of the cord yielded markedly different muscle responses, highlighting the need for such high-density arrays.

Flexible Parylene Packaged Intraocular Coil for Retinal Prostheses

We present a flexible and fully-implantable coil designed for use as a power and data transfer component in retinal prosthesis applications. Compared with traditional hand-made intraocular coils, this microfabricated coil is flexible, with a 9.5 mm outer diameter and 10-mum-thick parylene C as the primary structural and packaging material. A post-fabrication heat treatment was used to improve the parylene package in order to protect the device in harsh corrosive environments such as the human eye. Long-term accelerated-lifetime soak testing in heated saline has been performed, and the mean time to failure (MTTF) of the parylene package extrapolated to 37degC was estimated using the Arrhenius relationship. The electrical failure of this device was also characterized by measuring the DC resistance in saline