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

Description

Left ventricular assist deviceLVADsupport allows the neonate with congenital heart disease or cardiomyopathy to grow to a larger body weight that is more feasible for complex surgical correction or heart transplantThe Berlin Heart ExCORis FDA approved for pediatric LVAD applicationAlthough this device is outside the bodythe outflow graft may still create coronary artery heart compressionOur ultimate goal is to develop a less invasive and dependable LVAD system for the neonate as well as older pediatric patientsThe enabling technology is a double lumen cannulaDLCwhich is inserted from the apex into the aortaCoupled with an existing blood pumpthis DLC withdraws blood from the LV and delivers blood into the aortaunloading the LVOur DLC based LVAD only requires a one siteless invasive apex cannulationThe advantages areno outflow graft and associated heart coronary artery compressionno need of cardiopulmonary bypass and associated blood transfusionreserves more invasive sternotomy for future complex heart surgeryThis transapical to aortaTAADLC enables a high performance paracorporealextracorporeal LVAD and allows addition of a gas exchanger for cyanotic heart diseaseOur Phase I study proved that the TAA DLC based neonate LVAD system was very easy to implant via a small left thoracotomy and efficiently unloaded the LV forhours with no increase in free hemoglobin and no decrease in hemoglobin and platelet countsPhase II SBIR objectiveBased on the Phase I resultswe will optimize the design and fabricate a final commercial quality TAA DLC prototype for even smaller neonate application and forday survival lamb studiesSpecific AimTo designfabricateand bench test the high efficiencycommercial quality TAA DLC prototype for smaller neonate application and forday survival in vivo lamb studiesThe TAA DLC will be made of one piece reinforced polyurethaneComputational fluid dynamics will be used to optimize the DLC designA DLC anchoring system will be also developed to secure TAA DLC on apex and chest wall for long term ambulatory useAFrFr TAA DLC will be developed forkg neonate lamb acute study and aFrFr TAA DLC will developed forweek old lambkgsurvival studyThe final prototype will be tested for performancereliabilityand hemolysisThirty day durability will be tested inglycerinSpecific AimTo test newFr TAA DLC based LVAD inkg neonate lambnThishour study is designed to prove TAA DLC suitable for clinical neonate LVAD applicationWe will investigate ease of TAA deployment and in vivo performanceas well as potential aortic valve obstruction by extension infusion cannulaSpecific AimTo test the TAA DLC prototype fordays LVAD application inweeks old neonate lambnTheweek old lamb is still considered a neonate but almost fully weanedallowing us to performday survival studyThis in vivo study will test performancereliabilitydurabilityand biocompatibilityUpon this SBIR grant completionthe commercialized TAA DLC will provide a less invasive neonate LVAD We are proposing to develop a simpleless invasive double lumen cannula based left ventricular assist deviceLVADfor the neonate as well as older pediatric patientsThe enabling technology is the novel double lumen cannula which is coupled with a blood pump to form a LVAD system to provide total left ventricular supportthereby saving the lives of sick neonates and older pediatric patientsThis neonate LVAD system will bridge the patient to recoverytransplantor further advanced heart surgery