Browsing by Author "Thien, Patrick"

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    A Flexible Wireless System for Preclinical Evaluation of Retinal Prosthesis
    (MYU KK, 2018-01) Thien, Patrick; Millard, Rodney; Epp, Stephanie; Nayagam, David
    In this paper, we present a novel stimulation controller and monitoring system for evaluating the safety and efficacy of implantable neuroprosthetic devices in a preclinical setting. It features a programmable controller designed to be worn in a custom backpack by freely moving feline subjects. A custom controller powered two, modified, 22-channel clinical stimulators simultaneously. The controller and stimulators together weighed 140 g and measured 85 × 70 × 35 mm3. Power was supplied from a 3350 mAh lithium-ion battery. A Bluetooth-enabled laptop-PC base station managed up to six systems and allowed the remote adjustment of the stimulation amplitude and automated collection of stimulator telemetry data. The initial application was for the chronic safety testing of a 44-channel retinal prosthesis. Thirteen feline subjects were implanted with a suprachoroidal electrode array, which was then stimulated or monitored continuously for an average of 54.5 d. Batteries were changed twice weekly and electrode impedances were recorded hourly. This allowed broken electrodes and other issues to be quickly identified and addressed. The ability to remotely control the stimulation amplitude minimised the amount of subject handling that was required, likely reducing subject stress. Existing preclinical evaluation systems are either designed for short-term experiments and have many features but limited battery life, or for long-term static stimulation and are long-lived, but with restricted stimulation parameters and channel counts. Here, we have described a system designed to improve the chronic safety testing of electrode arrays. While it was used here with a suprachoroidal retinal implant, it could be readily adapted for other preclinical models requiring continuous, deterministic stimulation over a prolonged period.
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    Safety Studies for a 44-Channel Suprachoroidal Retinal Prosthesis: A Chronic Passive Study
    (IOVS, 2018-03) Abbott, Carla; Nayagam, David; Luu, Chi; Epp, Stephanie; Williams, Richard; Salinas-LaRosa, Cesar; Villalobos, Joel; McGowan, Ceara; Shivdasani, Mohit; Burns, Owen; Leavens, Jason; Yeoh, Jonathon; Brandli, Alice; Thien, Patrick; Zhou, Jenny; Feng, Helen; Williams, Chris; Shepherd, Robert; Allen, Penelope
    Abstract Purpose: Following successful clinical outcomes of the prototype suprachoroidal retinal prosthesis, Bionic Vision Australia has developed an upgraded 44-channel suprachoroidal retinal prosthesis to provide a wider field of view and more phosphenes. The aim was to evaluate the preclinical passive safety characteristics of the upgraded electrode array. Methods: Ten normal-sighted felines were unilaterally implanted with an array containing platinum electrodes (44 stimulating and 2 returns) on a silicone carrier near the area centralis. Clinical assessments (color fundus photos, optical coherence tomography, full-field electroretinography, intraocular pressure) were performed under anesthesia prior to surgery, and longitudinally for up to 20 weeks. Histopathology grading of fibrosis and inflammation was performed in two animals at 13 to 15 weeks. Results: Eight animals showed safe electrode array insertion (good retinal health) and good conformability of the array to the retinal curvature. Eight animals demonstrated good mechanical stability of the array with only minor (<2 disc diameters) lateral movement. Four cases of surgical or stability complications occurred due to (1) bulged choroid during surgery, (2) hemorrhage from a systemic bleeding disorder, (3) infection, and (4) partial erosion of thin posterior sclera. There was no change in retinal structure or function (other than that seen at surgery) at endpoint. Histopathology showed a mild foreign body response. Electrodes were intact on electrode array removal. Conclusions: The 44-channel suprachoroidal electrode array has an acceptable passive safety profile to proceed to clinical trial. The safety profile is expected to improve in human studies, as the complications seen are specific to imitations (anatomic differences) with the feline model.
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    Spatial Restriction of Neural Activation Using Focused Multipolar Stimulation With a Retinal Prosthesis
    (IOVS, 2016-06) Spencer, Thomas; Fallon, James; Thien, Patrick; Shivdasani, Mohit
    PURPOSE: The resolution provided by present state-of-the-art retinal prostheses is severely limiting for recipients, partly due to the broad spread of activation in the retina in response to monopolar (MP) electrical stimulation. Focused multipolar (FMP) stimulation has been shown to restrict neural activation in the cochlea compared to MP stimulation. We extended the FMP stimulation technique to a two-dimensional electrode array and compared its efficacy to MP and hexapolar (HP) stimulation in the retina. METHODS: Normally-sighted cats (n = 6) were implanted with a suprachoroidal electrode array containing 42 electrodes. Multichannel multiunit spiking activity was recorded from the visual cortex in response to MP, HP, and FMP retinal stimulation. RESULTS: When inferring retinal spread using voltage recordings off the stimulating array, FMP stimulation showed significantly reduced voltages in regions surrounding the primary stimulating electrode. When measuring the retinal and cortical selectivity of neural responses, FMP and HP stimulation showed significantly higher selectivity compared to MP stimulation (separate 2-way ANOVAs, P < 0.05). However, the lowest cortical thresholds for each stimulating electrode were higher for FMP and HP compared to MP stimulation (1-way ANOVA, P < 0.001). No significant differences were observed between FMP and HP stimulation in any measures. CONCLUSIONS: Focused multipolar and HP stimulation using a two-dimensional array are promising techniques to reduce the spread of activation for a retinal prosthesis. Clinical application would be expected to result in smaller phosphenes; thus, reducing phosphene overlap between electrodes and increasing the resolution at the expense of higher thresholds for activation.