SP23 Team Phantom Lead

Project Description:

Pacemakers are devices that artificially stimulate the heart in patients who have cardiac conduction system disorders, including bradycardia which is a slow heartbeat disorder that affects 1 in 600 people in the world. Traditionally, transvenous pacemakers were used to treat many conduction system disorders. These have a generator that is implanted in the chest and 1-3 leads that actively stimulate your heart muscle when it doesn’t beat on its own. However, these pacemaker leads cause severe complications in about 10% of patients, so to combat these issues, leadless pacemakers were recently created. They have no leads, but currently cannot pace the right atrium of the heart. This forces patients that need atrial pacing — including those bradycardia patients — to use traditional pacemakers, which subjects them to lead-related complications. Thus, our project explores anatomically-driven designs for a leadless pacemaker that can pace the right atrium. Leadless devices are difficult to implant in the right atrium due the high risk of tissue perforation. In our design, we took advantage of nearby vasculature for implantation. Our device has the pacemaker hardware anchored inside a stent and stimulating electrodes positioned around the base of the stent. The stent itself is deployed at the opening of the superior vena cava (SVC), which provides a good location for efficient atrial pacing. The stent design is not an active fixation mechanism and minimizes the risk of perforation — a significant concern for current leadless devices. Given the difficulty in removing and replacing our proposed device from the SVC, we also focused on exploring creative battery solutions like betavoltaic power sources that will improve longevity. We believe our leadless atrial pacemaker provides bradycardia patients with a treatment option that has reduced risk of the major complications associated with traditional pacemaker leads and current leadless technology.