A Fully Biodegradable, Implantable, Wireless, Battery-free, Miniaturized Cardiac Pacemaker with Closed-loop System for Neonatal and Pediatric Patients

一种完全可生物降解、可植入、无线、无电池、微型心脏起搏器，具有闭环系统，适用于新生儿和儿童患者

• 批准号: 10477206
• 负责人: Yeonsik Choi
• 金额: $ 10.31万
• 依托单位: NORTHWESTERN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10477206
• 关键词: Address; Adult; Algorithms; Anatomy; Area; Atrioventricular Block; Biomedical Engineering; Blood Vessels; Blood coagulation; Bluetooth; Bradycardia; Car Phone; Cardiac; Cardiac Electrophysiologic Techniques; Cardiac Surgery procedures; Cardiac pacemaker; Child; Clinical; Communication; Complex; Data; Development; Devices; Diagnostic; Electric Stimulation; Electric Stimulation Therapy; Electrocardiogram; Electrodes; Electromagnetics; Electronics; Epicardium; Fracture; Heart; Implant; Infection; Interdisciplinary Study; Intervention; Knowledge; Lung; Mechanics; Mentors; Modeling; Monitor; Movement; Nerve Regeneration; Operative Surgical Procedures; Pacemakers; Pathway interactions; Patient-Focused Outcomes; Patients; Polymers; Procedures; Property; Rattus; Research; Research Personnel; Research Project Grants; Retrieval; Risk; Site; Skin; Stretching; Surface; System; Technology; Testing; Therapeutic; Time; Tissues; Training; Water; base; biodegradable polymer; biomaterial compatibility; canine model; career; design; efficacy validation; electronic sensor; electronic stimulator; experimental study; improved; in vivo; in vivo evaluation; infection risk; materials science; miniaturize; miniaturized device; neonatal patient; novel; pediatric patients; premature; pressure; prototype; rapid growth; simulation; skills; surgical risk; time interval; tool; wireless; wireless sensor

Project Summary Despite the advancements in pacemaker technology, most pacemaking systems are designed for adults. The conventional implantable pacemakers are anatomically incompatible for neonatal and pediatric patients, causing therapeutic limitations and several short-term and/or long-term inconveniences. For example, current clinical external temporary pacemakers with percutaneous pacing leads for premature neonatal patients (< 2kg) have very limited days of use due to the risk of infection at the site where the electrodes penetrate the skin. Moreover, the dislodgement of these percutaneous leads is associated with many further complications1,2. When a permanent pacemaker is required, the device is incompatible in size for neonatal and pediatric patients, and the rapid growth of the child’s body creates pressures on the device that can cause fracturing in the leads at the tissue-electrode junction3. As a result, young patients must undergo more frequent interventions than adults to adapt their pacemaking devices to their changing anatomy4,5. However, extraction and replacement of pacemaker components is a complex surgical procedure with unavoidable risks, including tearing the surrounding blood vessel, perforating the heart, blood clot lodging in the lung, and eventual loss of vascular access4,6. We recently demonstrated an entirely biodegradable and biocompatible wireless electrical stimulator for neuroregenerative therapy7. Our successful experiments have led to the hypothesis that this approach of electrical stimulation will enable the development of a novel biodegradable cardiac pacemaker for neonatal and pediatric patients. The proposed miniaturized device (< 10 x 10 mm2,< 100 mg) will provide not only a wireless, battery-free means of pacing at the epicardium but also personalized device lifetime by resorbing after a defined time interval (6 days ~ 1+ year), thereby enabling therapeutic treatment without infection and reducing the risk of dislodgement. Additionally, we will develop a wireless, skin-interfaced controller with functions of real-time ECG monitoring, pacemaker powering, and Bluetooth communication. Pairing the skin- interfaced controller with the biodegradable pacemaker will realize a wireless, closed-loop system for autonomous cardiac electrotherapy and allow young patients to move freely during treatment. The development of the biodegradable cardiac pacemaker with a closed-loop system will create a pathway for new directions in biodegradable electronics for clinical use, including therapeutic and diagnostic implants. My mentors and research collaborators are experts in the design and fabrication of biomedical devices, cardiac electrophysiology, and cardiac surgery. This team of experts will help me to develop my full potential and launch my career as an independent, clinically inspired, biomedical engineering researcher, working to improve patient outcomes.

项目摘要 尽管起搏器技术取得了进步，但大多数起搏系统都是为成人设计的。 对于新生儿和儿科患者，常规的可植入的起搏器在解剖学上是不兼容的， 引起治疗局限性以及几个短期和/或长期影响。例如，当前 过早的新生儿患者的临床外部临时起搏器具有经皮起搏的铅（<<<<<< 2kg）使用天数非常有限，这是因为在电子渗透的地点感染了风险 皮肤。此外，这些经皮铅的披露与许多人有关 并发症1,2。当需要永久起搏器时，该设备的大小不兼容新生儿 和儿科患者，以及孩子身体的快速生长会在设备上造成压力 导致在组织 - 电极交界处的铅上裂缝3。结果，年轻患者必须经历更多 通常，干预措施要比成年人调整其起搏设备，以适应其变化的解剖学4,5。然而， 起搏器组件的提取和替换是一个复杂的手术程序，不可避免 风险，包括撕裂周围的血管，打孔心脏，血凝块在肺中堆放，以及 最终丧失血管访问4,6。 我们最近证明了一个完全可生物降解和生物相容性的无线电刺激器 用于神经加固疗法7。我们成功的实验导致了这样的假设，即这种方法 电刺激将使新的可生物降解的心脏起搏器用于新生儿 和儿科患者。提出的小型化设备（<10 x 10 mm2，<100 mg）不仅提供 无线，无电池在心外膜上起搏的手段，但也可以通过重新分辨来个性化设备寿命 经过定义的时间间隔（6天〜1岁以上），从而实现没有感染和的治疗治疗 降低披露风险。此外，我们将与 实时ECG监控，起搏器动力和蓝牙通信的功能。配对皮肤 - 与可生物降解的起搏器的干涉控制器将实现一个无线的闭环系统 自主心脏电疗疗法，并允许年轻患者在治疗过程中自由运动。 使用闭环系统的可生物降解心脏起搏器的开发将创建一个 可生物降解电子产品新方向的途径，用于临床使用，包括治疗和诊断 植入物。我的导师和研究合作者是生物医学设计和制造专家 装置，心脏电生理学和心脏手术。这个专家团队将帮助我发展完整 潜力并启动我作为独立，临床灵感，生物医学工程研究人员的职业， 致力于改善患者的预后。