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：
8516117
负责人：
HILTON G PRYCE LEWIS
金额：
$ 52.4万
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 2015-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8516117
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）：神经假体技术的微型化导致了迫切需要薄质的保形，绝缘涂层，这些涂层在长期内保留了其生物相容性和稳定性。长期以来，在医疗设备行业中，有机硅涂料用于其生物相容性和电绝缘性能。但是，常规的硅酮封装技术不适合许多微型医疗设备，包括某些神经普罗普塞斯中使用的可植入的慢性微电极阵列。引发化学蒸气沉积（ICVD）是使用基于溶剂的技术（例如浸入/喷雾和固化）应用的常规聚合物涂料的有吸引力替代品。 ICVD具有薄，整合性（非常适合复杂形状）和高纯度的好处。这项工作的目的是为慢性神经假体设备生产电绝缘，可生物固定的ICVD涂层。在第一阶段，我们已经证明，在恒定的扫描电压偏置下，ICVD有机硅涂层在模拟的体内环境中表现出延长的稳定性（在浸泡下6年以上而没有任何电阻率的损失），表现出极好的粘附和灵活性，是生物渗透性的，是生物渗透性的，并且会遇到USP塑料VI级要求。此外，我们通过线性硅氧烷间隔分子的代码表明，沉积速率增加了三倍，这使得该过程在商业化方面更加经济可行。在II期中，GVD将有资格有望的有希望的沉积条件和神经探针涂层的解散方法。体外测试的序列将使我们能够降低最有希望的条件。 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确认选定的探针涂层方法的适用性。在体内研究中证明的成功性能后，GVD将设计一种升级的涂料系统，优化了为成功涂料的经济高效的商业生产。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单步封装。在此II期下的稳定，耐用，生物相容性的绝缘涂层的开发将实现该目标。