Insulating Coatings for Implant Devices and Ribbon Cables

植入设备和带状电缆的绝缘涂层

• 批准号: 7294310
• 负责人: Helmut Eckhardt
• 金额: $ 80.61万
• 依托单位: PREMITEC, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-11-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7294310
• 关键词: 3-Dimensional; Animal Model; Area; Biocompatible Materials; Caliber; Canis familiaris; Clinical Trials; Complex; Data; Data Set; Development; Devices; Disease; Electric Stimulation; Electrodes; Environment; Event; Eye; Funding; Goals; Grant; Healed; Health; Hearing; Human; Impairment; Implant; In Vitro; Individual; Institutes; Lead; Materials Testing; Mechanics; Medical Device; Microelectrodes; Microfabrication; Miniaturization; Modeling; Movement; Nature; Nervous system structure; Neurons; Numbers; Patients; Phase; Physiological; Population; Preparation; Process; Prosthesis Design; Public Health; Retina; Retinal; Shapes; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Standards of Weights and Measures; Stroke; Surface; System; Technology; Testing; Tissues; Vision; Widespread Disease; Work; biomaterial compatibility; blind; commercialization; density; design; electronic stimulator; functional restoration; healing; implantable device; implantation; improved; in vivo; miniaturize; nervous system disorder; neural prosthesis; next generation; novel; pressure; relating to nervous system; research study; retinal damage; retinal prosthesis; seal

DESCRIPTION (provided by applicant): Summary Advancements in device miniaturization, integrated circuits packaging, microfabrication technologies, and biocompatible materials have made possible the development of complex neural prostheses designed to restore lost functions such as movement, hearing or vision. Neurological diseases result in significant impairment for millions of individuals worldwide. The requirements for these advanced neural interfaces are not met by currently approved implant devices, which use rigid packaging and are equipped with mostly single or low-density multielectrodes for sensing of physiological events or delivery of electrical stimulation. Neural prostheses such as retinal prostheses require a large number of electrodes, due to the amount of information that must be conveyed, and cannot rely on existing technology. To interface effectively with the nervous system and to open up new applications, miniaturized, flexible electrodes and packaging are needed. As continuation of an on-going Phase II SBIR grant entitled "Insulating Coatings for Implant Devices and Ribbon Cables" funded by the National Institute of Neurological Disorder and Stroke, we propose long term in-vitro and in-vivo studies for our flexible neural interfaces to collect a comprehensive set of data in preparation of clinical trials and regulatory approval. The retinal implant was chosen as test vehicle for our technology because of the complexity of the device with a large number of channels, the harsh environment for our encapsulation technology and the delicate nature of the tissue. However, the technology we develop will be easily applicable to other devices. We will develop novel, 3-dimensional wide field microelectrode arrays to improve contact to the retina and reduce damage to the tissue. Additionally, these electrode arrays will have a 10-mm diameter area of contact with the retina, thus enabling a wide field of vision. To enable testing of full system implants in vivo in dogs our interfaces will be connected to a proven hermetically sealed implantable stimulator electronics package from Second Sight. This is a key feature of this proposal made possible by our alliance with Second Sight. Years of development have gone into the microelectronics and materials for this next generation implant, and we will be able to leverage that development for this proposal. Advancements in microfabrication and materials have made possible the development of flexible neural interfaces. These medical devices are targeted at treating incurable neurological disorders and solve difficult technical problems that are limiting the capability of neural implant devices. Such diseases are widespread in the population as a whole and their impact on individual health is profound. The progress made by us so far with support from NINDS through Phase II SBIR demonstrates that our technology has the potential to lead to a successful commercialization of complex and challenging neural interfaces like the retinal stimulator and make a real impact on public health by increasing the capability of implantable neural prostheses.

描述（由申请人提供）：概述器械小型化、集成电路封装、微制造技术和生物相容性材料的进步使得开发旨在恢复丧失的功能（如运动、听力或视力）的复杂神经假体成为可能。神经系统疾病对全世界数百万人造成严重损害。目前批准的植入器械无法满足这些高级神经接口的要求，这些植入器械使用刚性包装，并且大多配备有单电极或低密度多电极，用于感测生理事件或输送电刺激。由于必须传递的信息量，神经假体（例如视网膜假体）需要大量电极，并且不能依赖于现有技术。为了有效地与神经系统连接并开辟新的应用，需要小型化，柔性电极和包装。作为国家神经疾病和中风研究所资助的正在进行的题为“植入器械和带状电缆的绝缘涂层”的第二阶段SBIR资助的延续，我们建议对我们的柔性神经接口进行长期的体外和体内研究，以收集一组全面的数据，为临床试验和监管批准做准备。选择视网膜植入物作为我们技术的测试工具，是因为该设备具有大量通道的复杂性，我们封装技术的恶劣环境以及组织的脆弱性。然而，我们开发的技术将很容易适用于其他设备。我们将开发新型的三维宽场微电极阵列，以改善与视网膜的接触并减少对组织的损伤。此外，这些电极阵列将具有与视网膜接触的10 mm直径区域，从而实现宽视野。为了能够在犬体内测试完整的系统植入物，我们的接口将连接到Second Sight经过验证的密封植入式刺激器电子设备包。这是我们与Second Sight联盟的一个关键特征。多年的发展已经进入了下一代植入物的微电子和材料，我们将能够利用这一发展来提出这一建议。微加工和材料的进步使得柔性神经接口的发展成为可能。这些医疗设备的目标是治疗无法治愈的神经系统疾病，并解决限制神经植入设备能力的困难技术问题。这些疾病在整个人口中普遍存在，对个人健康的影响深远。到目前为止，我们在NINDS的支持下通过第二阶段SBIR所取得的进展表明，我们的技术有可能导致复杂和具有挑战性的神经接口（如视网膜刺激器）的成功商业化，并通过提高植入式神经假体的能力对公众健康产生真实的影响。