Mechanical cardiac support has been shown to be an effective treatment in adults that suffer from congestive heart failure;however, there are limited options for treatment for the smallest of patients that present with heart failure. In the U.S., there are only two current options to treat infants (less than 10 kg), extracorporeal membrane oxygenation or ECMO and the Berlin Heart EXCOR. Both of these options are clinically difficult to manage and present clinical challenges in this patient population. Routinely used as bridge-to-transplant and bridge-to-recovery options for infant patients, the development of a more sophisticated and smaller mechanical support device would expand the treatment options for these patients. According to the U.S. Organ Procurement and Transplantation Network, up to 30% of the infants waiting for a heart transplant will die during any given year. The overall goal of this Phase I/II fast-track application is the development of th CircuLite(R) Nano Pump and Infant Cannula System (inlet cannula and delivery tools). The Nano Pump has evolved from technology first put to clinical use in the adult CircuLite Synergy(R) Partial Circulatory Support System. The primary component of the system, the Synergy Micro-pump, is already the smallest implantable blood pump to be used in human clinical trials, with an approximate size of an AA battery. Further development of the Nano Pump concept, which is 25% smaller than the Synergy Micro-pump, will be the primary focus during Phase I of this grant. While an excellent beginning to the design, the complex flow regions through the device are not yet fully understood. The milestone for Phase I will be to optimize the inlet housing and rotor of the Nano Pump using computational fluid dynamics (CFD), and verify the CFD results using experimental flow techniques. At the beginning of Phase II, the optimized Nano Pump will be implanted in a series of short-term (14-day) animals to evaluate hemodynamics. A retrospective 3-D reconstruction study of CT scan data and a surgical fit study of the Nano Pump and a flexible prototype cannula will also commence during this period. The surgical fit study will involve gathering data for size, location, angle and length of the Infat Cannula. Data from both the fit and retrospective studies will be utilized to design a novel Infant Cannula that will be compatible with the Nano Pump. Based on the results of the short-term (14-day) animals, the optimized Nano Pump and Infant Cannula will undergo a series of long-term (60-day) animal models to further assess the long-term biocompatibility of both devices. The milestone for Phase II of the project will be delivery of an optimized Nano Pump and Infant Cannula System that has completed long-term animal studies.
Long-term pediatric cardiovascular mechanical support for infants is an area that has largely been unfulfilled by medical device companies. The goal of this proposal will be to optimize and develop two components, the Nano Pump and Infant Cannula, of the CircuLite(R) Infant Circulatory Support System. The system will provide physicians a better alternative to treat the hundreds of infants per year who may otherwise die while waiting for a donor heart.