In-Line 32-Channel Connector for High-Density Implantable Medical Device

描述（由申请人提供）： 该提议的目的是开发下一代微型、高密度多通道连接器，其适合于长期植入患者体内，作为用于例如治疗外周神经系统疾病的系统的一部分。可以用这种方法治疗的疾病是行走问题，例如中风后，以及截肢后恢复幻肢的自然感觉。 在这项研究中，我们将使用定制的微型连接器机构，以促进内部和持久的神经接口之间的互连。还将开发微型连接器的定制包装和组装方法。本提案中待完成的任务包括制造与现有微型神经刺激器设计配合的新HD连接器。我们还将通过体外实验和动物手术试验评价这些连接器的长期生物相容性和生物稳定性。收集的数据将有助于将来向FDA申请，以便对采用高密度连接器技术的医疗器械进行后续临床研究。 拟议的努力与VA的患者护理使命之间的关系是，这些改进预计将提高具有高通道数的康复用植入式神经刺激系统组件的可扩展性。这将改善正在开发的新设备，如植入式助行器和恢复截肢自然感觉的设备。

DESCRIPTION (provided by applicant): The aim of this proposal is to develop the next generation of miniature, high- density multi-channel connectors suitable for chronic implantation in a patient's body as part of systems that are used, for example, to treat disorders of the peripheral nervous system. Maladies that could be treated in this way are problems with walking, such as after a stroke, and restoring natural sensations in a phantom limb after amputation. In this study, we will use custom-microfabricated connector bodies to facilitate interconnections within and among long-lasting neural interfaces. Custom packaging and assembly methods for the miniature connectors will also be developed. The tasks to be accomplished under this proposal include the fabrication of new HD connectors for mating with pre-existing micro-neurostimulator designs. We will also evaluate the long- term biocompatibility and bio-stability of these connectors through both in vitro experiments and animal surgical trials. The data collected will facilitate future application to the FDA to do follow-on clinical studies of medical devices incorporating high density connector technology. The relationship between the proposed effort and the patient care mission of the VA is that these improvements are expected to increase the interchangeability of components of implantable neurostimulation systems for rehabilitation that have high channel counts. This will improve new devices under development such as implantable walking aids and devices for restoring natural sensation in amputated limbs.