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

使用小型起搏和传感节点进行多腔起搏的无引线无线供电起搏器

• 批准号: 10004523
• 负责人: Aydin Babakhani
• 金额: $ 57.55万
• 依托单位: TEXAS HEART INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004523
• 关键词: Acute; Address; Affect; Algorithms; Animal Model; Animals; Arrhythmia; Cardiac; Cardiovascular Diseases; Catheters; Cessation of life; Chest; Cicatrix; Clinical; Conceptions; Data; Development; Device Designs; Device or Instrument Development; Devices; Diagnostic; Electric Countershock; Electrophysiology (science); Epicardium; Failure; Family suidae; Fracture; Frequencies; Heart; Heart Atrium; Heart failure; Implant; Individual; Infection; Injury; Intelligence; Lead; Left; Location; Medical; Methods; Modeling; Monitor; Myocardial; Myocardium; Outcomes Research; Output; Pacemakers; Painless; Pathologic; Patients; Physiologic pulse; Population; Procedures; Protocols documentation; Publishing; Quality of life; Risk; Running; Site; Skin; Sudden Death; Supervision; System; Techniques; Technology; Testing; Therapeutic; Tricuspid Valve Insufficiency; United States; Venous; Venous system; Ventricular; Width; Wireless Technology; algorithm development; cardiac pacing; cardiac resynchronization therapy; communication device; design; experimental study; heart damage; heart rhythm; implantation; improved; improved functioning; in vivo; innovation; migration; miniaturize; minimally invasive; novel; novel therapeutics; pediatric patients; personalized medicine; programs; wireless communication; wireless network

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.

项目摘要 全球每年有1700多万人死于心血管疾病。仅在美国，就有92.1 数百万人受到心血管疾病的影响，所有重大死亡中有32%是由心血管疾病造成的。一份 的心血管疾病患者存在需要植入起搏器的异常情况 保持正常的心率。起搏器是一种通过心脏向心脏发送常规电脉冲的装置 被称为导线的长线连接到放置在皮肤下的发电机。仅在美国， 每年有超过37万名患者植入心脏起搏器。与起搏器相关的并发症 在这些患者中，有10%发生了植入。这些并发症在很大程度上与设备有关，包括铅 衰竭、导线脱位、感染、三尖瓣返流和静脉闭塞。最近的事态发展 起搏器技术导致了无铅起搏器的出现，这种起搏器已经缩小到子弹大小 可以植入心脏内的装置。然而，这些设备目前的外形尺寸太大了 为儿科患者提供治疗。为了解决这个问题，我们开发了一种微型(11 mm×11 mm)， 无铅、无线供电的起搏设备，可以在心脏的多个位置同步起搏。我们的 在活体心脏多个心腔起搏的成功实验导致了这样的假设 多部位起搏的方法我们的技术将使微型设备的开发能够提供 无铅、无线供电的方式可以在前所未有的数量的站点和以前无法访问的站点中进行漫步 区域，从而增强心肌同步性和传导。在这项建议中，我们的目标是开发一种 包括无线供电的起搏和感应节点(SA 1)的分布式网络的系统，该系统可以 由数据驱动算法(SA 2)控制，以提供最佳的心脏再同步治疗。这个系统 将在亚急性在体猪心力衰竭模型(SA 3)中反复开发和验证。戴维斯博士。 Babakhani、Cavallaro和Lin将各自为硬件开发做出贡献。阿章博士将监督 开发数据驱动的算法，拉扎维博士将负责设备开发和所有动物 学习。该项目的研究成果将提高我们对无线电力传输的理解，导致 创造了新的体内设备间通信协议，并提供了一种创新的方法 起搏疗法。该装置在其完善的状态下将足够小，可以通过静脉输送，能够 从多个位置同步起搏和感知，并通过使用 检测患者特定节律异常的算法。这样的装置将对临床产生深远的影响 通过允许在多个位置进行步调，包括那些以前无法到达的位置。此外， 该装置将使受损心脏的传导正常化，以更好地管理心律失常，并可以提供 用于无痛复律的潜伏性低能量除颤。