Intravascular Deployment of a Wirelessly Powered Micro-Pacer

摘要 尽管最近在可植入生物医学装置方面取得了进展，但无线功率输送的利用仍在继续 由于限制足够功率传输的解剖尺寸限制，这是一个挑战。除了 起搏器、植入式刺激器，包括用于脊髓、脑深部的神经调节装置， 外周神经刺激，都受到相同的基于导线的架构的限制。因此，开发无线 包括起搏器在内的植入式器械的功率传输有可能缓解许多器械- 相关并发症。感应供电生物医学设备的主要挑战仍然是开发一种 具有足够功率输出的微尺度接收器天线，同时最小化发射器功率消耗， 一个解剖学上和无线电上可行的范围。消除了起搏导线、笨重的电池、固定相关 机械负担以及电池更换和器械撤回的重复程序仍然未得到满足 临床需要在这种情况下，我们寻求推进一种长距离感应供电的无线和无电池 微型（µ）系统，具有足够的功率用于起搏功能。我们令人鼓舞的初步结果支持了 具有皮下装置和微型起搏器装置的起搏系统诱导足够功率的可行性 用于离体起搏的转移到猪心脏。因此，我们解决了体内长期的基本限制- 使用血管内微起搏系统进行范围起搏。我们的目标是集成先进的天线和 电路设计到起搏器系统中，以使无线供电的μ起搏器能够在血管内部署到 心前静脉（ACV）起搏。我们的目标是消除器械固定和电极导线相关的机械故障 最佳功率传输效率的复杂性。为了实现我们的目标，我们有三个目标。目标1： 将展示基本的µ天线设计和制造，以提高功率传输效率。在 目标2，我们将集成CMOS技术和新型聚对二甲苯油包封， 部署.在目标3中，我们将在我们的临床前研究中展示用于实时血管内起搏的µ-起搏器。 模型这种无线电力传输系统的成功部署提供了理论和 实验框架，以克服限制足够功率传输的解剖尺寸约束， 对心脏和非心脏刺激的平移影响。

Abstract Despite recent advances in implantable biomedical devices, the utilization of wireless power delivery continues to be a challenge due to anatomical size constraints that limit sufficient power transfer. In addition to pacemakers, implantable stimulators, including neuromodulation devices used for spinal cord, deep brain, and peripheral nerve stimulation, are confined by the same lead-based architecture. Thus, developing wireless power transfer for implantable devices, including the pacemaker, has the potential to mitigate a host of device- related complications. A primary challenge in inductively powered biomedical devices remains in developing a micro-scale receiver antenna with sufficient power output while minimizing transmitter power consumption over an anatomically and wirelessly feasible range. Eliminating the pacing leads, bulky batteries, fixation-associated mechanical burden, and repeated procedures for battery replacement and device retraction remains an unmet clinical need. In this context, we seek to advance a long-range inductively powered wireless and batteryless micro (µ)-system with sufficient power for pacing functionality. Our encouraging preliminary results support the feasibility of a pacing system with a subcutaneous unit and micro-scale pacer unit to induce sufficient power transfer for ex vivo pacing to a porcine heart. We hereby address the fundamental constraints of in vivo long- range pacing using an intravascular micro-pacing system. Our objective is to integrate advanced antenna and circuit design into a pacer system to enable intravascular deployment of wirelessly powered µ-pacer to the anterior cardiac vein (ACV) for pacing. Our goal is to eliminate the device fixation- and lead-related mechanical complications for optimal power transfer efficiency. To deliver our objective, we have three aims. In Aim 1, we will demonstrate the fundamental µ-antenna design and fabrication to enhance power transfer efficiency. In Aim 2, we will integrate CMOS technology and the novel parylene-on-oil encapsulation to enable intravascular deployment. In Aim 3, we will demonstrate the µ-pacer for real-time intravascular pacing in our pre-clinical model. Successful deployment of this wireless power transmission system provides the theoretical and experimental framework to overcome the anatomical size constraints that limit sufficient power transfer with translational implications for both cardiac and non-cardiac stimulation.