CAIRDAC Autonomous Leadless Pacemaker powered by heart beats
DIRECT POWERING A REAL CARDIAC PACEMAKER BY
NATURAL ENERGY OF A HEARTBEAT
Smart-MEMPHIS has proven, in vitro, the feasibility of a leadless pacemaker powered by the energy harvested from heart beats. A bulk-MEMS piezoelectric energy harvester has been designed and a specific industrial process has been developed in order to manufacture harvesters fitting inside a pacemaker capsule of less than 1 cm3 and able to extract energy from the low frequency vibrations of cardiac beats. RESULT smart-MEMPHIS has proven, in vitro, the feasibility of a leadless pacemaker powered by the energy harvested from heart beats. A bulk-MEMS piezoelectric energy harvester has been designed and a specific industrial process has been developed in order to manufacture harvesters fitting inside a pacemaker capsule of less than 1 cm3 and able to extract energy from the low frequency vibrations of cardiac beats. smart-MEMPHIS proved that a dedicated bulk-MEMS piezoelectric energy harvester (PEH) when combined with an adapted Power Management Unit (PMU) is able to replace the primary battery of a single chamber leadless pacemaker. At smart-MEMPHIS project end, a prototype of a biocompatible leadless pacemaker integrating a bulk-MEMS piezoelectric energy harvester with the complete electronic of a communicating Bluetooth Low Energy pacemaker is ready for in-vivo chronic validation.
Current leadless pacemakers have a limited longevity caused by the small size of the implant battery. This limitation could be a real issue for the therapy delivery and patient comfort as there is yet no proven surgery to extract safely a depleted battery leadless pacemaker implanted inside the heart. There is a real need to increase the longevity of leadless pacemakers to more than 15 years while the current state of the art is around 7 years. When using an energy harvester to power the pacemaker, the longevity increase is also combined with the capability to integrate additional diagnostic and therapy functions for more benefits for the patients without impacting the longevity of the device. Although the energy harvesting technology has known important progress during the last decade, the main challenges to use an energy harvester to power a pacemaker are related to the low frequency content of the vibrations provided by the heart beat and to the dimension and reliability constraints of an implantable medical device. CAIRDAC with smart-MEMPHIS partners solved these issues thanks to a specific manufacturing process implemented by VERMON to fill the gap in the piezoelectric beam dimensions and reliability.
CAIRDAC has realized the proof of concept of a functional leadless pacemaker powered by an innovative dedicated piezoelectric energy harvester. The Technology Readiness Level achieved at the end of the project is TRL5. CAIRDAC and smart-MEMPHIS partners developed a Green Power Source for a leadless pacemaker that could also be used for other medical or IoT devices.