Insulating Coatings for Implant Devices and Ribbon Cables

描述(申请人提供)：设备小型化、集成电路封装、微制造技术和生物兼容材料的进步使复杂神经假体的开发成为可能，这些假体旨在恢复丧失的功能，如运动、听力或视觉。神经系统疾病对全世界数百万人造成重大损害。目前批准的植入设备无法满足对这些先进神经接口的要求，这些设备使用刚性封装，并大多配备单个或低密度多电极，用于检测生理事件或传递电刺激。神经假体，如视网膜假体，由于必须传达的信息量，需要大量的电极，不能依赖现有技术。为了有效地与神经系统对接并开拓新的应用，需要微型化、柔性的电极和封装。作为国家神经疾病和中风研究所正在进行的名为“植入设备和带状电缆的绝缘涂层”的第二阶段SBIR赠款的继续，我们建议对我们的灵活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。之所以选择视网膜植入物作为我们技术的测试载体，是因为该设备具有大量通道的复杂性，我们的封装技术所处的恶劣环境，以及组织的微妙性质。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视场微电极阵列，以改善与视网膜的接触，减少对组织的损害。此外，这些电极阵列将与视网膜有10毫米直径的接触区域，从而实现更宽的视野。为了能够在犬体内测试全系统植入物，我们的接口将连接到一个经过验证的密封的植入式刺激器电子组件。这是这项提议的一个关键特征，这是我们与第二视觉的联盟使之成为可能的。这种下一代植入物的微电子和材料已经进行了多年的开发，我们将能够利用这些开发来实现这一提议。微细加工和材料的进步使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疾病，并解决限制神经植入设备能力的技术难题。这种疾病在整个人口中普遍存在，对个人健康的影响是深远的。到目前为止，我们在NINDS的支持下通过第二阶段SBIR取得的进展表明，我们的技术有潜力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共健康产生真正的影响。

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.