Development and Translation of novel SiC encapsulation thin film for chronic auditory nerve implant electrodes

用于慢性听神经植入电极的新型 SiC 封装薄膜的开发和转化

基本信息

批准号：
10220177
负责人：
Stuart F Cogan
金额：
$ 74.96万
依托单位：
BLACKROCK MICROSYSTEMS
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-08-10 至 2022-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10220177
关键词：
3-Dimensional Acoustic Nerve Address Aging Architecture Auditory Prosthesis Basic Science Body Fluids Brain Brain Stem Ceramics Chemicals Chronic Clinical Cochlear Implants Complex Consult Data Deposition Development Devices Electrodes Electronics Encapsulated Environment Extravasation Failure Felis catus Film Geometry Gold Hearing Human Implant Implanted Electrodes In Vitro Institutes Lead Life Expectancy Longevity Mechanics Medical Device Metals Methods Microelectrodes Operative Surgical Procedures Patients Performance Peripheral Peripheral Nerves Phase Pilot Projects Polymers Process Property Publishing Reproducibility Research Risk Rodent Route Safety Scheme Semiconductors Sterilization Structure Study Subject Surface System Target Populations Techniques Technology Testing Texas Thinness Time Translating Translations United States National Institutes of Health Universities Utah Wireless Technology Work base biomaterial compatibility brain computer interface commercialization density design dielectric property electric impedance electrical property expectation follow-up human subject implantable device implantation improved in vitro testing in vivo microsystems nervous system disorder neural implant neuroprosthesis neurotransmission next generation nonhuman primate novel parylene performance tests phase 2 designs relating to nervous system risk mitigation silicon carbide standard of care surgical risk voltage

项目摘要

Abstract A range of neurological diseases are now being researched or treated using fully implantable electronic systems to either record or modulate brain activity in humans. These implants are currently being protected using polymer coatings that envelop the implant and help keep body fluids away from the sensitive electronics. Brain implants with complex three-dimensional geometries, like the Utah Electrode Array (UEA) provide a challenge for current encapsulation techniques. Parylene has been the gold standard for encapsulation of neural and biomedical implants in general due to its well-suited combination of biocompatibility, electrical properties and chemical inertness. However recording capabilities of long-term neural implants (>6 months) encapsulated with Parylene show signs of degradation. To address this problem, we propose to develop and evaluate performance and biocompatibility/safety of a new Silicon Carbide (SiC) based encapsulation designed to extend the long term stability and implantable lifetime for a high density Utah Slant Electrode Array (HD-USEA) in line with lifetime expectations for conventional cochlea implant electrodes. The HD-USEA is used as penetrating auditory nerve electrode in a new type of intracranial auditory prosthesis that targets the auditory nerve en route to the brainstem in order to substantially improve hearing performance over the current standard of care, the cochlear implant (CI) (NIH 1UG3NS107688-01). SiC has been studied in the past as encapsulation and electrode material due to its outstanding inherent material properties. This encapsulation layer, novel to biomedical field, will retain all the advantages of Parylene while utilizing vastly superior dielectric properties of silicon carbide layer to create a much longer lasting and more electrically stable biomedical implants. This layer encapsulation scheme may be seamlessly incorporated into our existing fabrication process flow for our flagship product, the UEA. This encapsulation will work on different surfaces (metal, semiconductor, polymer, ceramic) and on devices with integrated wireless components making it ideal for coating any complex medical device intended for long term implant. Our preliminary results with silicon carbide coated UEA are very promising in support of the proposed work. We have shown that silicon carbide yields more stable leakage current, and stable impedance (with <5% change). This superior performance of suggests its potential usefulness for chronic implants with complex surface geometries.

抽象的目前正在研究或使用完全植入式治疗一系列神经系统疾病记录或调节人类大脑活动的电子系统。这些植入物是目前正在使用聚合物涂层进行保护，该涂层包裹着植入物并有助于保持身体健康流体远离敏感电子设备。具有复杂三维结构的大脑植入物诸如犹他电极阵列 (UEA) 之类的几何形状为当前封装带来了挑战技术。聚对二甲苯已成为神经和生物医学封装的黄金标准由于其生物相容性、电性能和化学惰性。然而，长期神经植入物的记录能力（> 6 个月）用聚对二甲苯封装显示出降解迹象。为了解决这个问题，我们建议开发并评估新型碳化硅 (SiC) 的性能和生物相容性/安全性基于封装的设计旨在延长长期稳定性和可植入寿命，以实现高密度犹他倾斜电极阵列 (HD-USEA) 符合传统的寿命预期耳蜗植入电极。 HD-USEA 用作穿透性听觉神经电极新型颅内听觉假体，以听觉神经为目标脑干，以便在当前护理标准的基础上大幅提高听力表现，人工耳蜗 (CI) (NIH 1UG3NS107688-01)。 SiC由于其优异的性能，过去一直作为封装和电极材料进行研究。固有的材料特性。这种封装层对于生物医学领域来说是新颖的，将保留所有发挥聚对二甲苯的优点，同时利用碳化硅层极其优越的介电性能创造出更持久、电气更稳定的生物医学植入物。这一层封装方案可以无缝地融入我们现有的制造工艺流程中我们的旗舰产品 UEA。这种封装适用于不同的表面（金属、半导体、聚合物、陶瓷）以及具有集成无线组件的设备非常适合涂覆任何用于长期植入的复杂医疗设备。我们的初步碳化硅涂层 UEA 的结果非常有希望支持所提出的工作。我们已经表明碳化硅产生更稳定的漏电流和稳定的阻抗（与 <5% 变化）。这种卓越的性能表明其对于慢性植入物的潜在用途具有复杂的表面几何形状。