Schiemer Jonas F, Stumm Karen, Olsommer Yves, Lang Hauke, Baumgart Nadine, Baumgart Jan, Kneist Werner
Department of General, Visceral and Transplant Surgery, University Medical Center of the Johannes Gutenberg-University Mainz, Langenbeckstreet 1, Mainz, 55131, Germany.
Department of General and Visceral Surgery, St. Josefs-Hospital Wiesbaden, Beethovenstreet 20, Wiesbaden, 65189, Germany.
Langenbecks Arch Surg. 2025 Aug 12;410(1):242. doi: 10.1007/s00423-025-03834-1.
Gastric electrical stimulation (GES) is an effective treatment for gastroparesis. However, the available devices are equipped with bulky batteries that need to be replaced regularly by surgery.
Our new implantable system consists of only 6 passive components in addition to a diode and does not require a battery. Two acute porcine experiments were carried out with a robotic surgical system for placement of the prototypes. The stimulation parameters were set with an extracorporeal unit and GES was performed. The recorded electromyography (EMG) signal was subjected to a multiresolution analysis.
The robot-assisted placement of the prototypes was successful. The inductive energy transfer was confirmed to be functional and EMG analysis revealed changes in gastric electrical activity.
Further technological and rapid regulatory solutions are being sought in order to start a clinical trial with the next generation devices in the near future.
胃电刺激(GES)是治疗胃轻瘫的一种有效方法。然而,现有的设备配备有体积庞大的电池,需要定期通过手术进行更换。
我们的新型植入式系统除了一个二极管外仅由6个无源元件组成,且不需要电池。使用机器人手术系统进行了两项急性猪实验,用于放置原型。通过体外装置设置刺激参数并进行胃电刺激。对记录的肌电图(EMG)信号进行多分辨率分析。
原型的机器人辅助放置成功。感应能量传输被证实功能正常,EMG分析显示胃电活动有变化。
正在寻求进一步的技术和快速监管解决方案,以便在不久的将来启动下一代设备的临床试验。