Development of a Minimally Invasive Single Cannulation, Compact Single Port Pulsatile Ventricular Assist Device (sppVAD) for Total LV Support

Cardiogenic shock (CS) is a serious condition of low cardiac output with a 40-50% mortality. In severe CS, hypoperfusion causes multi-organ failure and high left ventricle (LV) preload/wall stress exacerbates cardiac injury/prevents recovery. Temporary mechanical circulatory support (MCS) is needed to restore perfusion and unload the LV, bridging the CS patient to recovery, long-term LV assist device (LVAD), or heart transplant. Venoarterial extracorporeal membrane oxygenation is most often used in severe CS, but it fails to unload LV in > 50% of these patients with no improved outcomes. Minimally invasive, percutaneous MCS devices also do not improve severe CS outcomes since they do not completely restore the circulation. Non-percutaneous MCS devices provide total support but require open chest surgery and are not ambulation friendly. Impella 5.5 has become the preferred MCS device for CS. Yet, patients with an Impella 5.5 must stay in ICU with very limited ambulation. Thus, a big market gap exists for an ideal temporary MCS device that: 1) is minimally invasive, 2) provides total LV support, and 3) enables easy ambulation. Our goal is to develop a new temporary MCS system that provides total LV support via a minimally invasive technique with easy ambulation, enabling patient discharge for at-home MCS. Our device will provide one month MCS (potential for up to 3 months) to bridge severe CS patient to further treatment, recovery, durable VAD, or heart transplant. Our enabling technology is a single port, pulsatile ventricular assist device (sppVAD) system that includes valved single lumen cannula (VSLC), valveless single port diaphragm displacement pump (spDDP), and compact/portable console. Our sppVAD system has following novel design:1) One VSLC for withdrawal and infusion; 2) single lumen design doubles usable area to reduce circuit blood resistance for >6 L/min pumping; 3) One transapical to aorta cannulation for minimally invasive installation; 4) Only one port reduces pump size for easy ambulation; 5) Simple valveless pump geometry for better durability and 1-month MCS. In the Phase I SBIR, our sppVAD system achieved >6 L/min pulsatile flow in bench test and 6 hr total LV unloading in sheep. Specific Aim 1: Optimize and fabricate VSLC, valveless spDDP, and compact/portable console for the sppVAD system. The VSLC will be made of reinforced polyurethane (PU). Inlet valves will be in LV for blood withdrawal. A tri- leaflet outlet valve on VSLC tip will be in aorta for blood delivery. The spDDP will be made of polycarbonate with a PU diaphragm. A compact/portable console will also be developed. Specific Aim 2: Bench test the sppVAD system for performance, durability, and hemocompatibility. The sppVAD system will be tested in mock loop for performance/durability and in an in vitro loop with bovine blood to quantify hemolysis. Specific Aim 3: Perform 4-week preclinical testing of sppVAD system in sheep. A near commercial quality sppVAD system will be tested in sheep (n=10) for safety/biocompatibility/reliability. Our novel sppVAD system fills a large unmet need for ambulatory, at-home temporary total LV support to improve patient outcomes.