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Human tissue temperatures achieved during recharging of new-generation neuromodulation devices

机译:新一代神经调节装置充电过程中达到的人体组织温度

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The advent of rechargeable biomedical implants for neuromodulation has introduced the practice of recharging implantable batteries through a patient's skin. Long-term operation of such implants is achieved by periodically recharging the implant's battery by means of a magnetic field produced by an antenna situated on the surface of the skin. During recharging periods, heat is generated within both the implant and the antenna. The heat flowing from these components into adjacent tissue creates the possibility of tissue temperature elevations that may be unsafe. This issue was investigated by means of a synergistic combination of experimentation and numerical simulation. The experiments measured the rates at which heat generated within the components flowed into their respective surroundings. This information was utilized as input information to the numerical simulations. The simulation model consisted of four tissue layers plus the skin-surface-mounted antenna. Two realistic external thermal environments were considered for the simulations. Both the experimentation and the simulations were performed for three leading neuromodulation devices: Precision Plus, Eon Mini, and Restore Ultra. In the presence of convective/radiative heat losses in a 20 ℃ environment, the maximum tissue temperature during recharging never exceeded 39 ℃ for the Restore Ultra, but exceeded 41 ℃ for the Precision Plus and the Eon Mini. In an adiabatic environment, similar findings were observed; the temperatures associated with the Precision Plus and Eon Mini exceeded 41 ℃, while the tissue temperatures near the Restore Ultra maintained values less than 41 ℃. The work reported here deals with devices that have not previously been investigated.
机译:用于神经调节的可充电生物医学植入物的出现引入了通过患者皮肤对可植入电池充电的实践。这种植入物的长期运行是通过利用位于皮肤表面的天线产生的磁场定期对植入物的电池进行充电来实现的。在充电期间,植入物和天线内都会产生热量。从这些组件流入相邻组织的热量产生了可能不安全的组织温度升高的可能性。通过实验和数值模拟的协同组合来研究此问题。实验测量了组件内部产生的热量流入其各自周围环境的速率。该信息被用作数值模拟的输入信息。仿真模型由四个组织层以及皮肤表面安装天线组成。模拟考虑了两个现实的外部热环境。对三种领先的神经调节装置进行了实验和仿真,分别是Precision Plus,Eon Mini和Restore Ultra。在20℃环境中存在对流/辐射热损失的情况下,Restore Ultra的充电过程中最高组织温度从未超过39℃,而Precision Plus和Eon Mini则超过41℃。在绝热环境中,观察到了相似的发现。 Precision Plus和Eon Mini的温度超过41℃,Restore Ultra附近的组织温度保持在41℃以下。此处报告的工作涉及以前未进行过调查的设备。

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