W-Z BIOTECH LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

Cardiogenic shockCSis a serious clinical condition of reduced cardiac outputCOwith end organ hypoperfusionIn severe CSend organ hypoperfusion leads to multi organ failureand elevated left ventricleLVpreload increases LV wall stressexacerbating myocardial injuryVenoarterial extracorporeal membrane oxygenationVA ECMOhas been increasingly used to support severe CS patients due to its high efficiencycost effectivenesswide availabilityand minimally invasive capabilityVA ECMO pumps almost total CO to normalize end organ perfusionHoweverVA ECMO is unable to unload the LV in severe CS patients with more thanof these patients developing LV distensionwhich further damages the myocardium and prevents myocardial recoveryIn VA ECMOsome blood still goes to the left heartbut the compromised LV fails to pump this blood outresulting in LV blood accumulationLV distensionCurrentlythere is no minimally invasive device specifically designed for LV unloading during VA ECMOOur ultimate goal is to develop a percutaneous device to unload the LV during VA ECMOfacilitating myocardial recoveryThe enabling technology is a percutaneous pulmonary arteryPAdrainage device that keeps the PA tricuspid valves persistently openallowing blood flow from the PA toward the right atrium for ECMO drainageThis results in a lower PA pressurePAPwhich decreases blood flow toward the left heart and enables retrograde blood flow from the left atrium to PA to efficiently unload the LVOur percutaneous PA drainage deviceis minimally invasive to eliminate complicated surgerydecreases PAP to decompress the heartprevents drainageinduced low central venous pressure to enhance VA ECMO drainageandmonitors PAP to confirm evaluate LV unloadingIn our LV distension sheep model with massive myocardial infarctionMIinduced severe CS and VA ECMO supportour first percutaneous PA drainage device prototype was properly deployed and efficiently unloaded the LVndemonstrating the LV unloading feasibility of our deviceOur objective in this Phase I SBIR is to develop fabricate a new percutaneous PA drainage device prototype for in vitro testing and in vivo testing in our LV distension sheep modelSpecific AimTo designfabricateand bench test a percutaneous PA drainage device prototypeThe prototype will be aFr triple lumen catheter based memory alloy wire cageThis cage will be close to the catheter for easy installation removal and will open inside the PA tricuspid valves to create valve regurgitationBack flow efficiency and valve opening reliability will be tested in a simulation mock loopSpecific AimTo test a percutaneous PA drainage device prototype in a LV distension sheep modelOur established LV distension sheep model with massive MIinduced severe CS and VA ECMO support will be used to test our percutaneous PA drainage device prototype for ease of deploymentLV unloading efficiencyandhour reliabilitynW Z Biotech will designfabricateand perform in vitro testing while the University of Kentucky will conduct the in vivo animal studies We are proposing to develop a percutaneous pulmonary artery drainage device to address the critical problem of left ventricular distension in VA ECMO supported severe cardiogenic shock patientsThe enabling technology is aFr triple lumen catheter based memory alloy wire cage that keeps the pulmonary and tricuspid valves persistently open to efficiently unload the left ventricleOur percutaneous pulmonary artery drainage device will facilitate myocardial recovery in severe cardiogenic shock patientssignificantly impacting their outcomes