School of Engineering and Informatics, NUI Galway, University Road, Galway, Ireland.
Med Eng Phys. 2011 Jan;33(1):7-16. doi: 10.1016/j.medengphy.2010.08.010. Epub 2010 Nov 18.
The BION (Bionic Neuron) is a single channel implantable neurostimulator of unique design that can be delivered by injection. The development of the BION injectable neurostimulators exemplifies a challenging, but well posed medical design problem addressed with a successful strategy for prioritizing and resolving the biomedical and technological challenges. Though some performance requirements required post-evaluation revision, all fundamental goals were realized. A small number of significant design corrections occurred because the device requirements did not include the full scope of environmental demands. The design has spawned a number of variants optimized for diverse biomedical applications, and its clinical applications continue to evolve. The BION development history demonstrates design successes worth emulating and design pitfalls that may be avoidable for future medical device development teams. This paper serves as an introduction to the BION microstimulator technology and as an analysis of the design process used to develop the early clinical devices.
BION（仿生神经元）是一种独特设计的单通道可植入神经刺激器，可通过注射进行输送。BION 可注射神经刺激器的开发体现了一个具有挑战性但得到妥善解决的医学设计问题，采用了成功的策略来确定优先级并解决生物医学和技术挑战。尽管一些性能要求需要在评估后进行修订，但所有基本目标都已实现。由于设备要求不包括全部环境要求，因此发生了少量重大设计更正。该设计催生了许多针对不同生物医学应用进行了优化的变体，其临床应用也在不断发展。BION 的开发历史证明了值得效仿的设计成功案例，以及未来医疗器械开发团队可能避免的设计缺陷。本文旨在介绍 BION 微刺激器技术，并分析用于开发早期临床设备的设计过程。
