Silicone Coatings for Biostable Chronic Neural Prostheses

用于生物稳定慢性神经假体的有机硅涂层

基本信息

批准号：
8320142
负责人：
HILTON G PRYCE LEWIS
金额：
$ 71.94万
依托单位：
GVD CORPORATION
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-01 至 2014-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8320142
关键词：
Address Adhesions Animals Automation Biocompatible Biocompatible Coated Materials Blindness Brain Chemicals Chemistry Child Chronic Complex Defect Deposition Development Device Designs Device or Instrument Development Devices Dimensions Electrodes Environment Epilepsy Exhibits Exposure to Goals Growth Immersion Investigative Technique Implant In Vitro Industry Journals Liquid substance Manufacturer Name Medical Device Mental Depression Methods Microelectrodes Miniaturization Molecular Weight Nanotechnology Nerve Tissue Nervous System Physiology Neurons Neurosciences Parents Parkinson Disease Performance Phase Physiological Plastics Polymers Positioning Attribute Process Production Property Prosthesis Qualifying Reproducibility Research Institute Research Personnel Resistance Resources Running Saline Series Services Shapes Silicones Siloxanes Simulate Solutions Solvents Structure System Techniques Technology Testing Thick Thinness Time Work base biomaterial compatibility commercialization comparative cost cost effective design flexibility implantation in vitro testing in vivo interest meetings monomer nano nervous system disorder neural prosthesis neuroprosthesis parylene performance tests programs relating to nervous system success tool vapor voltage

项目摘要

DESCRIPTION (provided by applicant): The miniaturization of neuroprosthetic technology has led to an urgent need for thin, conformal, insulating coatings that retain their biocompatibility and stability over long periods. Silicone coatings have long been used in the medical device industry for their biocompatibility and electrically insulating properties. However, conventional silicone encapsulation technologies are unfit for many miniature medical devices including implantable, chronic microelectrode arrays used in some neuroprosheses. Initiated Chemical Vapor Deposition (iCVD) is an attractive alternative to conventional polymer coatings applied using solvent-based techniques such as dip/spray and curing. iCVD has the benefits of thinness, conformality (conforms very well to complex shapes) and high purity. The goal of this work is to produce electrically insulating, biostable iCVD coatings for chronic neural prosthetic devices. In Phase I, we have demonstrated that iCVD silicone coatings exhibit prolonged stability in simulated in-vivo environments under constant sweeping voltage bias (6+ years under soak without any loss in resistivity), show excellent adhesion and flexibility, are bioinert, and meet USP Plastic Class VI requirements. Furthermore, we have demonstrated a three folds increase in deposition rate via the codeposition of a linear siloxane spacer molecule, making the process even more economically viable for commercialization. In Phase II, GVD will qualify promising deposition conditions and de-insulation methods for neural probe coatings. A serives of in-vitro tests will allow us to downselect the most promising conditions. GVD will partner with Dr. William Shain (Seattle Children's Research Institute) to confirm the suitability of selected probe coating methods through staggered in vivo studies. Upon successful performance demonstrated during the in vivo studies, GVD will design an upgraded coating system optimized for cost-effective commercial production of successful coatings. The ultimate goal of this work is to achieve single step encapsulation of three-dimensional neural probe arrays and of neural prosthetic assemblies. The development of a stable, durable, biocompatible insulating coating under this Phase II will enable that goal to be achieved.

描述（由申请人提供）：神经假体技术的小型化导致迫切需要薄的、保形的绝缘涂层，以长期保持其生物相容性和稳定性。有机硅涂层因其生物相容性和电绝缘特性而长期应用于医疗器械行业。然而，传统的硅胶封装技术不适合许多微型医疗设备，包括一些神经假体中使用的可植入、慢性微电极阵列。引发化学气相沉积 (iCVD) 是使用溶剂型技术（例如浸涂/喷涂和固化）的传统聚合物涂层的有吸引力的替代方案。 iCVD 具有薄、共形（非常适合复杂形状）和高纯度的优点。这项工作的目标是为慢性神经假体设备生产电绝缘、生物稳定的 iCVD 涂层。在第一阶段，我们证明 iCVD 有机硅涂层在恒定扫描偏压下的模拟体内环境中表现出长期稳定性（浸泡 6 年以上，电阻率没有任何损失），表现出出色的附着力和柔韧性，具有生物惰性，并且符合 USP塑料 VI 级要求。此外，我们还证明，通过线性硅氧烷间隔分子的共沉积，沉积速率提高了三倍，使得该工艺在商业化方面更加经济可行。在第二阶段，GVD 将验证神经探针涂层有前景的沉积条件和去绝缘方法。一系列体外测试将使我们能够筛选出最有希望的条件。 GVD 将与 William Shain 博士（西雅图儿童研究所）合作，通过交错的体内研究来确认所选探针涂层方法的适用性。在体内研究中证明成功的性能后，GVD 将设计一种升级的涂层系统，针对成功涂层的经济高效的商业生产进行优化。这项工作的最终目标是实现三维神经探针阵列和神经假体组件的一步封装。在第二阶段开发稳定、耐用、生物相容的绝缘涂层将使这一目标得以实现。