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

• 批准号: 7326923
• 负责人: HILTON G PRYCE LEWIS
• 金额: $ 10万
• 依托单位: GVD CORPORATION
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7326923
• 关键词: 3-Dimensional; Address; Adhesions; Adhesives; Area; Benign; Biocompatible; Biocompatible Coated Materials; Biological; Blindness; Brain; Businesses; Cells; Characteristics; Chemicals; Chemistry; Chronic; Class; Communities; Compatible; Complex; Condition; Data; Defect; Deposition; Depth; Development; Device Designs; Device or Instrument Development; Devices; Digit structure; Dimensions; Electrodes; Ensure; Environment; Epilepsy; Equipment; Evaluation; Excision; Exposure to; Film; Funding; Gases; Goals; Growth; Heating; Housing; Immersion Investigative Technique; Implant; In Vitro; Individual; Industry; Investments; Joint Ventures; Lead; Liquid substance; Manufacturer Name; Marketing; Measurement; Measures; Mechanics; Medical Device; Mental Depression; Miniaturization; Modeling; Modification; Nanotechnology; Neurologic; Neurons; Numbers; Parkinson Disease; Performance; Phase; Physiological; Plasma; Pliability; Polymers; Polytetrafluoroethylene; Positioning Attribute; Preparation; Process; Production; Property; Prosthesis; Pump; Qualifying; Rate; Reaction; Research; Research Personnel; Resistance; Sales; Saline; Sampling; Screening Result; Screening procedure; Services; Shapes; Silanes; Silicon; Silicones; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Solutions; Solvents; Staging; Standards of Weights and Measures; Structure; Surface; System; Techniques; Technology; Temperature; Testing; Therapeutic; Thick; Thinness; Time; Work; aqueous; base; biomaterial compatibility; commercialization; cytotoxicity test; experience; implantation; improved; in vivo; liquid crystal polymer; monomer; nervous system disorder; neural prosthesis; novel; programs; prototype; relating to nervous system; research study; scale up; silane; size; success; tool; touchscreen; vapor; voltage

DESCRIPTION (provided by applicant): The miniaturization of neuroprosthetic technology has led to an urgent need for insulating coatings that retain their biocompatibility and stability over long periods. Initiated Chemical Vapor Deposition (iCVD) is an attractive alternative to applying polymers 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. Recent preliminary experiments at MIT (where GVD's technology was invented) have demonstrated that a pure silicone coating possessing many of the material properties required for insulation of neuroprosthetics can be deposited from the vapor phase using the iCVD process. Silicones offer many advantages over other coating materials, including exceptional resistance to a variety of chemical environments, inert under soak, and both an extremely high resistivity and a low dielectric constant. Silicones also offer the additional advantage of excellent adhesion to a variety of substrates - a critical requirement for neuroprosthetic components which consist of multiple materials and interfaces. The goal of this work is to optimize the processing conditions for this new silicone coating and develop a material that satisfies all of the requirements of chronic implantation in a neurological environment. In the Phase I work, GVD plans to address several challenges of the current coating process, including improving yield of coatings free of defects, decreasing processing temperatures that can damage sensitive neural devices, and increasing the rate of coating deposition for commercial feasibility. These goals will be achieved by optimizing the process chemistry to enable reproducible coating at more benign process conditions. In addition to these tasks, in vitro biocompatibility testing will be performed including USP Class VI testing and targeted cytotoxicity testing using PC12 neuronal cells. In Phase I, coatings will be produced and tested on flat substrates approximating neural devices and interdigitated electrodes (IDEs) to measure insulation properties. In Phase II, the work would be expanded to optimizing the coating for neural devices for testing by researchers in the field and in vivo biocompatibility testing. 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 silicone coating under this Phase I will enable that goal to be achieved. The success of this Phase I will allow GVD to offer to researchers & manufacturers of neural prostheses a new option for a safe and robust biopassivation coating for the insulation and encapsulation of neuroprosthetic devices. The silicone coating developed under this work will provide greater flexibility in the design of devices, the choice of materials used, and the minimum dimensions which can be achieved in neuroprosthetic devices. Therapeutically, the coating will perform better when implanted and provide safe and effective protection of devices in chronic applications. The long-term impact will be to de-bottleneck the development of devices and accelerate their proliferation as treatments for neurological disorders.

描述（由申请人提供）：神经假体技术的小型化导致迫切需要能够长期保持生物相容性和稳定性的绝缘涂层。引发化学气相沉积 (iCVD) 是使用溶剂型技术（例如浸渍/喷涂和固化）涂覆聚合物的一种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。麻省理工学院（GVD 技术的发明地）最近的初步实验表明，可以使用 iCVD 工艺从气相沉积出具有神经假体绝缘所需的许多材料特性的纯硅酮涂层。与其他涂层材料相比，有机硅具有许多优点，包括对各种化学环境的出色耐受性、浸泡时的惰性以及极高的电阻率和低介电常数。有机硅还具有对各种基材具有出色粘附力的额外优势，这是由多种材料和界面组成的神经假体组件的关键要求。这项工作的目标是优化这种新型有机硅涂层的加工条件，并开发一种满足神经环境中慢性植入的所有要求的材料。在第一阶段的工作中，GVD 计划解决当前涂层工艺的几个挑战，包括提高无缺陷涂层的产量、降低可能损坏敏感神经设备的加工温度，以及提高涂层沉积速率以实现商业可行性。这些目标将通过优化工艺化学物质以在更良性的工艺条件下实现可重复的涂层来实现。除了这些任务之外，还将进行体外生物相容性测试，包括 USP VI 级测试和使用 PC12 神经元细胞的靶向细胞毒性测试。在第一阶段，将在类似于神经装置和叉指电极（IDE）的平面基底上生产和测试涂层，以测量绝缘性能。在第二阶段，工作将扩展到优化神经设备的涂层，以供研究人员进行现场测试和体内生物相容性测试。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。在第一阶段开发稳定、耐用、生物相容的绝缘有机硅涂层将使这一目标得以实现。 第一阶段的成功将使 GVD 能够为神经假体的研究人员和制造商提供一种新的选择，用于神经假体装置的绝缘和封装的安全且坚固的生物钝化涂层。这项工作开发的有机硅涂层将为设备设计、所用材料的选择以及神经假体设备可实现的最小尺寸提供更大的灵活性。在治疗上，该涂层在植入时将表现更好，并为长期应用中的设备提供安全有效的保护。长期影响将是消除设备开发的瓶颈，并加速其作为神经系统疾病治疗方法的扩散。