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一种可植入式无线无电池空间选择性迷走神经刺激器

An implantable wireless battery-free spatially selective vagus nerve stimulator.

基础研究耳科IF 4.5Q2

文献信息

PMID42735697
原文在 PubMed 查看原文 ↗
发表日期2026
作者Edvards Rutkovskis
查看其他 14 位作者

Enrico Ravagli；Henry T Lancashire；Ahmad Shah Idil；Nicole Thompson；Justin D Perkins；Ronald Challita；Joseph Hadaya；Umesh Vivekananda；Olujimi Ajijola；Kalyanam Shivkumar；Anna Miserocchi；Andrew McEvoy；David S Holder；Kirill Y Aristovich

作者单位Medical Physics and Biomedical Engineering, University College London, Malet Place Engineering Building - Gower Street - London, London, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.
查看其他 9 条单位信息

Medical Physics and Biomedical Engineering, University College London, Malet Place Engineering Building, London, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.；Medical Physics and Biomedical Engineering, University College London, Malet Place Engineering Building - Gower Street, London, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.；Medical Physics and Bioengineering, University College London, Malet Place Engineering Building - Gower Street, London, England, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.；Clinical Science and Services, The Royal Veterinary College Department of Clinical Science and Services, Hawkshead Ln, Brookmans Park, Hatfield, England, AL9 7TA, United Kingdom of Great Britain and Northern Ireland.；UCLA Cardiac Arrhythmia Center and Neurocardiology Research Program of Excellence, University of California Los Angeles David Geffen School of Medicine, 10833 Le Conte Ave, Los Angeles, California, 90095, United States.；National Hospital for Neurology and Neurosurgery, Queen Square, London, WC1N 3BG, United Kingdom of Great Britain and Northern Ireland.；UCLA Cardiac Arrhythmia Center and Neurocardiology Reseatch Program of Excellence, University of California Los Angeles David Geffen School of Medicine, 10833 Le Conte Ave, Los Angeles, California, 90095, United States.；Medical Physics and Bioengineering, University College London, Malet Place Engineering Building, Gower Street, London, England, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.；Medical Physics and Biomedical Engineering, University College London, Malet Place Engineering Building - Gower Street - London, London, England, WC1E 6BT, United Kingdom of Great Britain and Northern Ireland.

期刊Journal of neural engineering
SCI 分区Q2
IF4.5
研究类型基础研究 · 基础／转化
所属专科耳科

中文摘要

目的： 迷走神经刺激（VNS）是治疗耐药性癫痫和其他炎症性疾病的成熟临床疗法。然而，非靶向刺激可能产生不必要的副作用，限制了治疗性刺激并阻碍了新型神经调控疗法的开发。选择性VNS（sVNS）提供了一种减少非靶器官激活的策略；然而，这种方法尚未在人类中应用，也没有可植入或便携式设备可在临床环境中试验sVNS。本研究旨在设计、制造和验证一种可植入式无线、无电池刺激器，其具有可选择寻址的输出级，用于将电流靶向递送至人类迷走神经（VN）的特定区域。
方法： 我们开发了一种近场通信控制、无线供电、无电池、临时可植入的多通道刺激设备，与15通道sVNS袖带电极（14个选择性电极对和一个环周全神经通道）兼容。该设备经过封装以用于短期植入，并通过台式表征、加速老化以及在急性猪和初步人体研究中的验证进行了评估。
主要结果： sVNS设备在猪（n = 4）试验和首次人体初步研究（n = 1）中进行了评估。在猪中观察到选择性心动过缓为23.28 ± 12.91%，在人类参与者中为7.5%。在人类中，观察到心动过缓和心动过速效应的明显分离，并且在喉部活动中具有额外的选择性。心脏和喉部反应在神经圆周上相隔231°。
意义： 这项工作证明了使用临时可植入设备进行无线无电池sVNS用于心脏应用的可行性。几何选择性刺激有可能提高治疗效果，同时减少刺激相关的副作用，并可能促进未来对心力衰竭和其他自主神经疾病的治疗。

英文摘要

OBJECTIVE: Vagus nerve stimulation (VNS) is an established clinical therapy for drug-resistant epilepsy and other inflammatory conditions. However, off-target stimulation can produce unwanted side effects that limit therapeutic stimulation and hinder the development of new neuromodulation therapies. Selective VNS (sVNS) offers a strategy to reduce off-target organ activation; however, this approach is not available in humans, and no implantable or portable devices exist to trial sVNS in the clinical setup. This work aimed to design, manufacture, and validate an implantable wireless, battery-free stimulator with a selectively addressable output stage for targeted current delivery to specific regions of the human vagus nerve (VN).
APPROACH: We developed a near-field communication-controlled, wirelessly powered, battery-free, temporary implantable multichannel stimulation device, compatible with a 15-channel sVNS cuff electrode (14 selective electrode pairs and one circumferential whole-nerve channel). The device was encapsulated for short-term implantation and evaluated through benchtop characterisation, accelerated ageing, and validation in an acute porcine and a pilot human study.
MAIN RESULT: The sVNS device was evaluated in a porcine (n = 4) trial and a first-in-human pilot study (n = 1). Selective bradycardia of 23.28 ± 12.91% was observed in pigs and 7.5% in the human participant. In the human, a clear separation of bradycardic and tachycardic effects was observed, with additional selectivity in laryngeal activity. Cardiac and laryngeal responses were separated by 231° around the circumference of the nerve.
SIGNIFICANCE: This work demonstrates the feasibility of wireless battery-free sVNS for cardiac applications using a temporary implantable device. Geometrically selective stimulation has the potential to improve therapeutic efficacy while reducing stimulation-related side effects, and may facilitate future therapies for heart failure and other autonomic disorders.