Leadless wirelessly powered pacemaker for multi chamber pacing using miniaturized pacing and sensing node

项目摘要 心血管疾病每年在全世界夺去1700多万人的生命。仅在美国，92.1 100万人受到心血管疾病的影响，32%的主要死亡归因于心血管疾病。 的心血管疾病人群有需要植入起搏器的异常， 保持正常的心律。起搏器是一种通过心脏起搏器向心脏发送有规律的电脉冲的装置。 一根叫做导线的长导线连接到皮肤下的发电机上。仅在美国， 每年有超过37万名患者植入起搏器。起搏器相关并发症 这些患者中有10%发生植入。这些并发症主要与器械相关，包括 失效、电极导线脱位、感染、三尖瓣返流和静脉闭塞。最近的事态发展 起搏器技术已经导致了无引线起搏器，它已经将起搏器缩小到子弹大小， 可以植入心脏的装置。然而，这些设备在其当前的形状因子中太笨重 为儿科患者提供治疗。为了解决这个问题，我们开发了一个微型（11 mm × 11 mm）， 无导线、无线供电的起搏设备，可同步起搏心脏的多个位置。我们 在体内起搏心脏的多个腔室的成功实验已经导致了这样的假设 多部位起搏的方法将使我们的技术能够开发微型设备， 在前所未有的数量的部位和以前无法进入的区域， 区域，从而增强心肌同步和传导。在这项建议中，我们的目的是发展一个 包括无线供电的起搏和感测节点（SA 1）的分布式网络的系统， 由数据驱动算法（SA 2）控制，以提供最佳心脏起搏治疗。该系统 将在亚急性体内猪心力衰竭模型（SA 3）中迭代开发和验证。Drs. Babakhani、Cavallaro和林将分别为硬件开发做出贡献。Aazhang博士将监督 数据驱动算法的开发，Razavi博士将监督设备开发和所有动物 问题研究该项目的研究成果将提高我们对无线电力传输的理解， 创建了新颖的内部设备间通信协议，并提供了一种创新的方法， 起搏治疗处于其精制状态的装置将足够小以用于经静脉递送，能够 从多个位置同步起搏和感知，并通过使用 检测患者特异性节律异常的算法。这种设备将产生深远的临床影响 通过允许在多个位置起搏，包括那些以前无法接近的位置。而且 设备将使受损心脏的传导正常化，以更好地管理心律失常， 用于无痛心脏复律的不易察觉的低能量除颤。

Project Summary Cardiovascular diseases claim more than 17 million lives worldwide every year. In the United States alone, 92.1 million people are affected by cardiovascular disease, and 32% of all major deaths are attributed to it. A portion of the cardiovascular disease population has abnormalities that necessitate implantation of a pacemaker to maintain normal heart rhythm. A pacemaker is a device that sends regular electrical impulses to the heart via long wires called leads connected to a generator placed underneath the skin. In the United States alone, pacemakers are implanted in more than 370,000 patients annually. Complications related to pacemaker implantation occur in 10% of these patients. These complications are largely device-related and include lead failure, lead dislodgement, infection, tricuspid regurgitation, and venous occlusion. Recent developments in pacemaker technology have led to leadless pacemakers, which have shrunk the pacemaker into a bullet-sized device that can be implanted inside the heart. However, these devices in their current form factor are too bulky to provide therapy to pediatric patients. To address this problem, we developed a miniature (11 mm × 11 mm), leadless, wirelessly powered pacing device that can pace multiple locations across the heart synchronously. Our successful experiments in pacing multiple chambers of the heart in vivo has led to the hypothesis that this approach of multisite pacing will our technology will enable the development of miniature devices that will provide leadless, wirelessly powered means of pacing at unprecedented numbers of sites and in previously inaccessible regions, thereby enhancing myocardial synchronization and conduction. In this proposal, we aim to develop a system comprising of a distributed network of wirelessly powered pacing and sensing nodes (SA 1) that can be controlled by a data-driven algorithm (SA 2) to provide optimal cardiac resynchronization therapy. This system will be iteratively developed and validated in a subacute in vivo porcine model of heart failure (SA 3). Drs. Babakhani, Cavallaro, and Lin will each contribute to the hardware development. Dr. Aazhang will supervise the development of the data-driven algorithm, and Dr. Razavi will oversee device development and all animal studies. Research outcomes from this project will improve our understanding of wireless power transfer, lead to the creation of novel intracorporeal inter-device communication protocols, and offer an innovative approach to pacing therapies. The device in its refined state will be small enough for transvenous delivery, capable of synchronous pacing and sensing from multiple locations, and deliver appropriate personalized therapy by using algorithms to detect patient-specific rhythm abnormalities. Such a device will have far-reaching clinical impact by allowing pacing at multiple locations, including those that were previously inaccessible. Furthermore, the device will normalize conduction across a damaged heart to better manage arrhythmia and can provide imperceptible low-energy defibrillation for painless cardioversion.