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

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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.