SBIR Phase I: Development of a highly reliable continuous wireless monitoring system for cardiac patients through implantable sensors

This Small Business Innovation Research (SBIR) Phase I project will develop a battery-free and wireless pressure sensing system for monitoring physiologic parameters, such as pressure, of infant/child's heart during and after cardiac surgery. Transthoracic intracardiac catheters have been the current standard practice in the neonatal and pediatric populations for monitoring physiologic parameters, which can change rapidly and may require immediate intervention. However, three major risks for current intracardiac line technology are 1) infection, due to transcutaneous passage of the catheter, which poses high risks for infection, sepsis, and endocarditis. 2) embolization and drug exposure risks inherent in maintaining catheter lumen patency; and 3) the bleeding risk from catheter withdrawal. The reality is that one out of four kids dies from the catheter removal. With the recent advancements in integrated circuitry, sensing, microfabrication, and wireless communications, an implantable, biocompatible, battery-free, wireless pressure sensing system will be developed to allow direct physiologic intracardiac monitoring that carries little or no bleeding and infection risks. This new polymeric planar pressure sensing system is based on resistance changes of unique patterned gold coatings, which is low-cost, fully biocompatible, highly sensitive and easy to fabricate. This novel sensing system may be used in many other pressuring sensing applications. The broader impact/commercial potential of this project is the contribution to the implantable wireless sensing product commercialization. The battery-free and wireless sensing technologies may revolutionize the vital sign monitoring in healthcare and also eliminate many potential clinical complications with traditional catheter based sensors, such as bleeding, infection, and so on. Since there is no safe sensing technology for monitoring physiologic parameters of infant/child's heart during and after cardiac surgery, this new wireless sensor system is likely to be approved quickly by FDA under the Orphan Device Act of 1983 and the FDA Humanitarian Device Exemption. This new sensing product will help many young children and their families. In addition, the same battery-free and wireless sensing technologies may also be used in adult medical sensing devices and other non-medical based pressuring sensing applications. The wide range of applications of this new sensing technology may have high commercial impact.