Project Grant R43HL162109

DEVELOPMENT OF A MINIMALLY INVASIVE PARTIAL CIRCULATORY SUPPORT DEVICE FOR CHRONIC USE - PROJECT SUMMARY THE NAUTILUS PUMP IS A CENTRIFUGAL, TOTALLY IMPLANTABLE, COMPACT, LONG-LASTING PARTIAL CIRCULATORY ASSIST DEVICE IMPLANTED VIA A MINIMALLY INVASIVE PACEMAKER POCKET APPROACH TO SUPPORT LV FUNCTION FOR LATE-STAGE HEART FAILURE INTERVENTION. THE NAUTILUS PUMP WILL BE CONNECTED TO THE SYSTEMIC CIRCULATION BY ATTACHMENT OF THE PUMP'S INFLOW PORT TO A CANNULA PLACED INTO THE SUBCLAVIAN VEIN AND POSITIONED IN THE LEFT ATRIUM VIA A TRANSSEPTAL APPROACH, AND THE OUTFLOW PORT TO A VASCULAR GRAFT ANASTOMOSED TO THE SUBCLAVIAN ARTERY. THIS REVOLUTIONARY PARTIAL SUPPORT PUMP IS BEING DESIGNED TO ELIMINATE THE NEED FOR INVASIVE TECHNIQUES TO IMPLANT FULL SUPPORT DEVICES (STERNOTOMY OR THORACOTOMY) AND ELIMINATE THE NEED FOR PERCUTANEOUS CABLES AND/OR DRIVELINES. THE NAUTILUS PUMP AND SYSTEM WILL BE A MINIMALLY INVASIVE, LOW ENERGY CONSUMPTION SYSTEM THAT WILL NOT IMPOSE EXCESSIVE AFTERLOAD ON THE LV, THEREFORE MAINTAINING PULSATILITY. FURTHERMORE, IT WILL RETAIN NATIVE HEART VENTRICULAR MUSCLE INTEGRITY, OFFERING THE BEST ENVIRONMENT FOR LV RECONDITIONING. ANOTHER FEATURE TO BE INTEGRATED TO THE PUMP IS THE NEXT-GENERATION TRANSCUTANEOUS ENERGY TRANSFER (TET) SYSTEM, WHICH DOES NOT REQUIRE DIRECT EXTERNAL COIL SKIN CONTACT TO POWER THE PUMP. THIS IS A REMARKABLE FEATURE THAT IS NOT PRESENT IN ANY OTHER COMPETITORS' SYSTEMS. LEVERAGING PUMP AFFINITY LAWS, WHICH GOVERN CENTRIFUGAL PUMP PERFORMANCE AND ARE USEFUL TO MODIFY PUMPS FOR NEW AND DIFFERENT REQUIRED DUTIES, AND THE COMPANY'S EXTENSIVE INTELLECTUAL PROPERTY PORTFOLIO, THE NAUTILUS PUMP IS BEING DESIGNED BASED ON OUR FULL SUPPORT ASSIST PUMP. IT WILL COMBINE PERMANENT MAGNETIC LEVITATION WITH A LOW SHEAR HYDRODYNAMIC BEARING TO PRODUCE AN ULTRA-LOW POWER CONSUMPTION PUMP THAT STILL RETAINS THE SUPERIOR BLOOD HANDLING CHARACTERISTICS OF FULL MAGLEV TECHNOLOGY. THIS HIGHLY EFFICIENT PUMP IS THEN COMBINED WITH IMPLANTABLE GRADE BATTERIES AND A LIGHT, EXTERNAL MOBILE WIRELESS POWER SOURCE, MAKING IT A TOTALLY IMPLANTED AND WIRELESSLY POWERED SYSTEM THAT DOES NOT REQUIRE A PERCUTANEOUS DRIVELINE, DIRECT SKIN CONTACT, OR BULKY EXTERNAL BATTERIES. IN-VIVO PRELIMINARY STUDIES USING THE FULL CIRCULATORY SUPPORT PUMP DEVICE VALIDATED ALL THE INNOVATIVE FEATURES IN THIS GRANT PROPOSAL, SUCH AS A HIGH-EFFICIENCY PUMP WITH A LOW HEMOLYSIS RATE. THIS SBIR PHASE I PROPOSED GRANT OBJECTIVES ARE ADDRESSED IN TWO SPECIFIC AIMS THAT WILL BE EXECUTED FOR EIGHT MONTHS. IN AIM 1, THE NAUTILUS PUMP WILL BE DESIGNED, AND A PROTOTYPE IS FABRICATED TO ACCOMMODATE 2 - 3 L/MIN FLOWS AT PHYSIOLOGIC PRESSURES. IN AIM 2, IN-VITRO STUDIES, USING A RECIRCULATING BLOOD TEST LOOP, WILL BE PERFORMED TO DETERMINE RED BLOOD CELL HEMOLYSIS, PLATELET AND LEUKOCYTE ACTIVATION, VWF DEGRADATION, AND FUNCTION, AS WELL AS OVERALL BLOOD HEMOSTATIC POTENTIAL, COMPARED TO OUR FULL CIRCULATORY SUPPORT PUMP AND THE BPX-80 BIO PUMP (MEDTRONIC - MINNEAPOLIS, MN, US). THE CONCLUSION OF THE PROPOSED AIMS WILL DEMONSTRATE THE FEASIBILITY AND HEMOCOMPATIBILITY OF THE NAUTILUS PUMP DESIGN. IT WILL SET THE STAGE FOR A PHASE II SBIR GRANT APPLICATION WHERE THE PERFORMANCE, SAFETY, AND SUITABILITY OF THE DEVICE WILL BE EVALUATED IN AN IN-VIVO SETTING, IN ADDITION TO THE DEVELOPMENT OF A TRANSEPTAL CANNULA.