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In vitro reliability testing and in vivo lifespan estimation of wireless Pixium Vision PRIMA photovoltaic subretinal prostheses suggest prolonged durability and functionality in clinical practice.
Journal of Neural Engineering ( IF 4 ) Pub Date : 2020-06-11 , DOI: 10.1088/1741-2552/ab8f70
Delphine Lemoine 1 , Emmanuel Simon , Guillaume Buc , Martin Deterre
Affiliation  

Objective. Retinal implants have the potential to restore some sight in patients with retinal degeneration. The PRIMA implant’s novel design features simpler insertion and no transscleral cabling or extraocular components. This in vitro study investigated PRIMA’s durability under real time and accelerated conditions and estimated the device’s lifespan in vivo. Approach. Two potential failure modes were examined: corrosion and overstimulation. Real-time aging was tested using implants immersed in balanced saline solution (BSS) at 37 °C, mimicking the intraocular environment. Accelerated aging was examined at 77 °C (Arrhenius theory). Confirmatory testing of acceleration factor was performed using different temperatures (37 °C–87 °C) and weakened implant coatings. The effect of repeated maximum stimulation was tested using a pulsed infrared laser (6x acceleration factor). Data were used to estimate device lifespan. Main results. 175 implants were teste...

中文翻译:

无线Pixium Vision PRIMA光伏视网膜下假体的体外可靠性测试和体内寿命估算表明,其在临床实践中具有更长的耐用性和功能性。

目的。视网膜植入物有可能使视网膜变性患者恢复视力。PRIMA植入物的新颖设计具有更简单的插入功能,并且没有跨巩膜布线或眼外组件。这项体外研究调查了PRIMA在实时和加速条件下的耐久性,并估计了该装置在体内的寿命。方法。检查了两种潜在的失效模式:腐蚀和过度刺激。使用浸没在37°C的平衡盐溶液(BSS)中的植入物(模拟眼内环境)测试实时老化。在77°C下检查加速老化(Arrhenius理论)。使用不同的温度(37°C–87°C)和较弱的植入物涂层进行了加速因子的验证性测试。使用脉冲红外激光(6倍加速因子)测试了重复最大刺激的效果。数据用于估计设备寿命。主要结果。175个植入物被测试
更新日期:2020-06-11
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