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.

项目概要 尽管起搏器技术取得了进步，但大多数起搏器系统都是为成人设计的。 传统的植入式起搏器在解剖学上不适合新生儿和儿科患者， 治疗局限性和一些短期和/或长期的不便，例如目前的情况。 用于早产新生儿患者的带有经皮起搏导线的临床外部临时起搏器（< 2kg）的使用天数非常有限，因为电极穿透部位存在感染风险 此外，这些经皮导线的移位还与许多其他损伤有关。 并发症1,2 当需要永久起搏器时，该装置的尺寸不适合新生儿。 和儿科患者，儿童身体的快速生长给设备带来了压力， 导致组织-电极连接处的导线断裂3 因此，年轻患者必须接受更多的治疗。 比成年人更频繁地进行干预，以使起搏装置适应不断变化的解剖结构4,5。 起搏器部件的取出和更换是一个复杂的外科手术，不可避免 风险，包括撕裂周围血管、穿孔心脏、血栓滞留在肺部，以及 最终失去血管通路4,6。 我们最近展示了一种完全可生物降解且生物相容的无线电刺激器 我们成功的实验得出了这样的假设：这种方法 电刺激将有助于开发一种用于新生儿的新型可生物降解心脏起搏器 所提议的小型化装置（< 10 x 10 mm2，< 100 mg）不仅可以提供 无线、无电池的心外膜起搏方式，还可以通过吸收来个性化设备的使用寿命 在规定的时间间隔（6天~1年以上）后，可以进行治疗，从而不会发生感染，并且 此外，我们将开发一种无线皮肤接口控制器。 实时心电图监测、起搏器供电和蓝牙通信等功能。 带有可生物降解起搏器的接口控制器将实现无线闭环系统 自主心脏电疗，允许年轻患者在治疗期间自由活动。 具有闭环系统的可生物降解心脏起搏器的开发将创造一个 临床可生物降解电子产品新方向的途径，包括治疗和诊断 我的导师和研究合作者是生物医学设计和制造方面的专家。 该专家团队将帮助我充分发展我的能力。 潜力并开启我作为一名独立的、受临床启发的生物医学工程研究员的职业生涯， 致力于改善患者的治疗效果。