Dalrymple Ashley N, Jones Sonny T, Fallon James B, Shepherd Robert K, Weber Douglas J
Department of Biomedical Engineering, University of Utah, Salt Lake City, UT, USA.
Department of Physical Medicine and Rehabilitation, University of Utah, Salt Lake City, UT, USA.
Bioelectron Med. 2025 Mar 14;11(1):6. doi: 10.1186/s42234-025-00168-7.
Implanted neural interfaces are electronic devices that stimulate or record from neurons with the purpose of improving the quality of life of people who suffer from neural injury or disease. Devices have been designed to interact with neurons throughout the body to treat a growing variety of conditions. The development and use of implanted neural interfaces is increasing steadily and has shown great success, with implants lasting for years to decades and improving the health and quality of life of many patient populations. Despite these successes, implanted neural interfaces face a multitude of challenges to remain effective for the lifetime of their users. The devices are comprised of several electronic and mechanical components that each may be susceptible to failure. Furthermore, implanted neural interfaces, like any foreign body, will evoke an immune response. The immune response will differ for implants in the central nervous system and peripheral nervous system, as well as over time, ultimately resulting in encapsulation of the device. This review describes the challenges faced by developers of neural interface systems, particularly devices already in use in humans. The mechanical and technological failure modes of each component of an implant system is described. The acute and chronic reactions to devices in the peripheral and central nervous system and how they affect system performance are depicted. Further, physical challenges such as micro and macro movements are reviewed. The clinical implications of device failures are summarized and a guide for determining the severity of complication was developed and provided. Common methods to diagnose and examine mechanical, technological, and biological failure modes at various stages of development and testing are outlined, with an emphasis on chronic in vivo characterization of implant systems. Finally, this review concludes with an overview of some of the innovative solutions developed to reduce or resolve the challenges faced by implanted neural interface systems.
植入式神经接口是一种电子设备,其目的是通过刺激神经元或记录神经元活动,来改善神经损伤或疾病患者的生活质量。人们已设计出能与全身神经元相互作用的设备,用于治疗越来越多的病症。植入式神经接口的开发和应用正在稳步增加,并已取得巨大成功,植入物可持续数年至数十年,改善了许多患者群体的健康状况和生活质量。尽管取得了这些成功,但植入式神经接口要在用户的一生中保持有效仍面临众多挑战。这些设备由多个电子和机械部件组成,每个部件都可能容易出现故障。此外,与任何异物一样,植入式神经接口会引发免疫反应。中枢神经系统和周围神经系统中的植入物引发的免疫反应会有所不同,而且会随时间变化,最终导致设备被包裹。本综述描述了神经接口系统开发者所面临的挑战,特别是已在人体中使用的设备。文中描述了植入系统各部件的机械和技术故障模式。描绘了周围神经系统和中枢神经系统对设备的急性和慢性反应,以及它们如何影响系统性能。此外,还综述了诸如微观和宏观运动等物理挑战。总结了设备故障的临床影响,并制定并提供了确定并发症严重程度的指南。概述了在开发和测试的各个阶段诊断和检查机械、技术和生物故障模式的常用方法,重点是植入系统的慢性体内特征描述。最后,本综述最后概述了为减少或解决植入式神经接口系统所面临的挑战而开发的一些创新解决方案。