James D. Weiland

Visual perception in a blind subject with a chronic microelectronic retinal prosthesis

A retinal prosthesis was permanently implanted in the eye of a completely blind test subject. This report details the results from the first 10 weeks of testing with the implant subject. The implanted device included an extraocular case to hold electronics, an intraocular electrode array (platinum disks, 4 x 4 arrangement) designed to interface with the retina, and a cable to connect the electronics case to the electrode array. The subject was able to see perceptions of light (spots) on all 16 electrodes of the array. In addition, the subject was able to use a camera to detect the presence or absence of ambient light, to detect motion, and to recognize simple shapes.

Retinal prosthesis for the blind

Most of current concepts for a visual prosthesis are based on neuronal electrical stimulation at different locations along the visual pathways within the central nervous system. The different designs of visual prostheses are named according to their locations (i.e., cortical, optic nerve, subretinal, and epiretinal). Visual loss caused by outer retinal degeneration in diseases such as retinitis pigmentosa or age-related macular degeneration can be reversed by electrical stimulation of the retina or the optic nerve (retinal or optic nerve prostheses, respectively). On the other hand, visual loss caused by inner or whole thickness retinal diseases, eye loss, optic nerve diseases (tumors, ischemia, inflammatory processes etc.), or diseases of the central nervous system (not including diseases of the primary and secondary visual cortices) can be reversed by a cortical visual prosthesis. The intent of this article is to provide an overview of current and future concepts of retinal and optic nerve prostheses. This article will begin with general considerations that are related to all or most of visual prostheses and then concentrate on the retinal and optic nerve designs. The authors believe that the field has grown beyond the scope of a single article so cortical prostheses will be described only because of their direct effect on the concept and technical development of the other prostheses, and this will be done in a more general and historic perspective.

A neuro-stimulus chip with telemetry unit for retinal prosthetic device

In this retinal prosthesis project, a rehabilitative device is designed to replace the functionality of defective photoreceptors in patients suffering from retinitis pigmentosa (RP) and age-related macular degeneration (AMD). The device consists of an extraocular and an intraocular unit. The implantable component receives power and a data signal via a telemetric inductive link between the two units. The extraocular unit includes a video camera and video processing board, a telemetry protocol encoder chip, and an RF amplifier and primary coil. The intraocular unit consists of a secondary coil, a rectifier and regulator, a retinal chip with a telemetry protocol decoder, a stimulus signal generator, and an electrode array. This paper focuses on the design, fabrication, and testing of a microchip which serves as the telemetry protocol decoder and stimulus signal generator. It is fabricated by MOSIS with 1.2-mm CMOS technology and was demonstrated to provide the desired biphasic current stimulus pulses for an array of 100 retinal electrodes at video frame rates.

In vitro electrical properties for iridium oxide versus titanium nitride stimulating electrodes

Stimulating electrode materials must be capable of supplying high-density electrical charge to effectively activate neural tissue. Platinum is the most commonly used material for neural stimulation. Two other materials have been considered: iridium oxide and titanium nitride. This study directly compared the electrical characteristics of iridium oxide and titanium nitride by fabricating silicon substrate probes that differed only in the material used to form the electrode. Electrochemical measurements indicated that iridium oxide had lower impedance and a higher charge storage capacity than titanium nitride, suggesting better performance as a stimulating electrode. Direct measurement of the electrode potential in response to a biphasic current pulse confirmed that iridium oxide uses less voltage to transfer the same amount of charge, therefore using less power. The charge injection limit for titanium nitride was 0.87 mC/cm/sup 2/, contradicting other reports estimating that titanium nitride was capable of injecting 22 mC/cm/sup 2/. Iridium oxide charge storage was 4 mC/cm/sup 2/, which is comparable to other published values for iridium oxide. Electrode efficiency will lead to an overall more efficient and effective device.

Chronic neural stimulation with thin-film, iridium oxide electrodes

Experiments were conducted to assess the effect of chronic stimulation on the electrical properties of the electrode-tissue system, as measured using electrochemical impedance spectroscopy (EIS) and cyclic voltammetry (CV). Silicon, micromachined probes with multiple iridium oxide stimulating electrodes (400-1600 micron 2) were implanted in guinea pig cortex. A 10-17 day post-operative recovery period was followed by five days of monopolar stimulation, two hours/electrode each day using biphasic, constant current stimulation (5-100 microA, 100 microseconds/phase). EIS and CV data were taken before and after stimulation. The post-stimulation impedance [at mid-range frequencies (100 Hz-100 kHz)] consistently and significantly decreased relative to prestimulation levels. Impedance magnitude increased permanently at low frequencies (< 100 Hz), correlating to a change in the charge storage capacity (the area under a cyclic voltammagram). Impedance magnitude significantly increased during the recovery period, though this increase could be mostly reversed by applying small currents. A mathematical model of the electrode-tissue system impedance was used to analyze in vivo behavior. The data and modeling results shows that applying charge to the electrode can consistently reduce the impedance of the electrode-tissue system. Analysis of explanted probes suggests that the interaction between the tissue and electrode is dependent on whether chronic pulses were applied. It is hypothesized that the interface between the tissue and metal is altered by current pulsing, resulting in a temporary impedance shift.

An optimal design methodology for inductive power link with class-E amplifier

This paper presents a design methodology of a highly efficient power link based on Class-E driven, inductively coupled coil pair. An optimal power link design for retinal prosthesis and/or other implants must take into consideration the allowable safety limits of magnetic fields, which in turn govern the inductances of the primary and secondary coils. In retinal prosthesis, the optimal coil inductances have to deal with the constraints of the coil sizes, the tradeoffs between the losses, H-field limitation and dc supply voltage required by the Class-E driver. Our design procedure starts with the formation of equivalent circuits, followed by the analysis of the loss of the rectifier and coils and the H-field for induced voltage and current. Both linear and nonlinear models for the analysis are presented. Based on the procedure, an experimental power link is implemented with an overall efficiency of 67% at the optimal distance of 7 mm between the coils. In addition to the coil design methodology, we are also presenting a closed-loop control of Class-E amplifier for any duty cycle and any value of the systemQ.

An Integrated 256-Channel Epiretinal Prosthesis

This paper reports an integrated 256-channel epiretinal prosthesis integrated circuit (IC). This epiretinal prosthesis system consists of a power telemetry subsystem to deliver 100 mW power, a data telemetry subsystem to transfer 2 Mbps data, digital controllers to decode stimulation patterns, and a 256-channel stimulator to generate user programmable bi-phasic current stimuli. In this study, dual-band telemetry is adopted to achieve both high power efficiency and high data rate. Frequencies of 2 and 22 MHz are chosen for power and data carrier frequencies, respectively. A mixed-mode and multiple-voltage design is applied to the stimulator for withstanding a high-compliance voltage of ± 10 V at the output stage as well as for reducing the area of each pixel. To add flexibility to the stimulator, each pixel has a local digital controller, which enables the stimulator IC to generate 256 parallel stimulations with various pulse widths and amplitudes. The chip is fabricated in TSMC 0.18 μm 32 V CMOS process with 256 area pads constructed above the stimulus current drivers.

Perceptual thresholds and electrode impedance in three retinal prosthesis subjects

Three test subjects blind from retinitis pigmentosa were implanted with retinal prostheses as part of a FDA-approved clinical trial. The implant consisted of an extraocular unit that contained electronics for wireless data, power, and generation of stimulus current, and an intraocular unit that consisted of 16 platinum stimulating electrodes arranged in a 4 /spl times/ 4 pattern within a silicone rubber substrate. The array was held to the retina by a small tack. The stimulator was connected to the array by a multiwire cable and was controlled by a computer based external system that allowed precise control over each electrode. Perception thresholds and electrode impedance were obtained on each electrode from the subjects over several months of testing. The electrode distance from the retina was determined from optical coherence tomography imaging of the array and retina. Across all subjects, average thresholds ranged from 24-702 /spl mu/A (1-ms pulse). The data show that proximity to the retina played a role in determining the threshold and impedance, but only for electrodes that were greater than 0.5 mm from the retina.

A variable range bi-phasic current stimulus driver circuitry for an implantable retinal prosthetic device

This paper reports a driver circuitry to generate bi-phasic (anodic and cathodic) current pulses for stimulating the retinal layer through electrodes which is part of a retinal prosthetic device for implants in blind patients affected by retinitis pigmentosa (RP) and age-related macular degeneration (AMD). Dual voltage architecture is used to halve the number of interface leads from the chip to the stimulation sites compared to a single voltage supply. The driver circuitry is designed to deliver currents with six bit resolution for a wide range of full scale currents up to 600 /spl mu/A. To cater to the varying stimulus requirements among patients and different regions of the retina, variable gain architecture is used to achieve fine resolution even for a narrow range of stimulus. 1:8 demultiplexing feature is embedded within the output stage thus allowing one DAC for eight outputs. A novel charge cancellation circuitry with current limiting capability is implemented to discharge the electrodes for medical safety. Measurement results of a prototype chip fabricated in 1.5-/spl mu/m CMOS technology are presented.

Factors Affecting Perceptual Thresholds in Epiretinal Prostheses

PURPOSE The goal was to evaluate how perceptual thresholds are related to electrode impedance, electrode size, the distance of electrodes from the retinal surface, and retinal thickness in six subjects blind as a result of retinitis pigmentosa, who received epiretinal prostheses implanted monocularly as part of a U.S. Food and Drug Administration (FDA)-approved clinical trial. METHODS The implant consisted of an extraocular unit containing electronics for wireless data, power recovery, and generation of stimulus current, and an intraocular unit containing 16 platinum stimulating electrodes (260- or 520-microm diameter) arranged in a 4 x 4 pattern. The electrode array was held onto the retina by a small tack. Stimulation was controlled by a computer-based external system that allowed independent control over each electrode. Perceptual thresholds (the current necessary to see a percept on 79% of trials) and impedance were measured for each electrode on a biweekly basis. The distance of electrodes from the retinal surface and retinal thickness were measured by optical coherence tomography on a less regular basis. RESULTS Stimulation thresholds for detecting phosphenes correlated with the distance of the electrodes from the retinal surface, but not with electrode size, electrode impedance, or retinal thickness. CONCLUSIONS Maintaining close proximity between the electrode array and the retinal surface is critical in developing a successful retinal implant. With the development of chronic electrode arrays that are stable and flush on the retinal surface, it is likely that the influence of other factors such as electrode size, retinal degeneration, and subject age will become more apparent. (ClinicalTrials.gov number, NCT00279500.).