3DT HOLDINGS, LLC — Department of Health and Human Services SBIR Phase I: NHLBI

Description

ABSTRACT Arterial and venous reconstructions are frequently needed to reestablish circulation in various diseasesorgan transplantationsinterventional operationstraumaetcAutologous graftsmostly saphenous veinsare the gold standard for vascular patches to reconstruct arteries and veinsThe disadvantages of autologous venous patcheshoweverare obviousincluding multiple surgerieslimitations on dimensions and numbers of donor sitesand donor complicationsSynthetic and biological materials are used to supplement autologous patches in clinical practice but have a number of shortcomingsSynthetic patches have relatively high rate of occlusion and risk of pseudoaneurysm formation and infection which may require life long follow up in susceptible populationsBiological materials have been used to reconstruct arteries and veins with variable outcomes which suggest the need for further refinementIn this Phase I SBIR proposalwe propose to evaluate the pulmonary visceral pleuraPVPas a biological patch for reconstruction of arteries and veins in vascular surgeryThe PVP plays an important role in lung functionand is inherently compliant and non thrombogenicOur preliminary data show that glutaraldehyde fixed PVP patches implanted in carotid and femoral arteries and jugular veins maintained excellentmonth patency and developed functional neo endothelial andsmooth muscle cellsWe hypothesize that the PVP patch will vascularize in vivo and therefore provide long term patencysince the nonthrombogenic nature of the structure of mesothelium and the biocompatibility of PVP patches to promote vascular tissue self assemblyTo test this hypothesiswe will validate the safety and efficacy of the PVP patches using conduit artery and vein in a translational swine modelWe will carry out these studies in aged and hyperlipidemic swine modelsince vascular repair or reconstruction are frequently needed in the aging patients with hyperlipidemic complicationsThis proposal addresses a clinically significant problem and successful completion will provide surgeons with various size options of patches for vascular surgery to ultimately improve patient outcomesPVP is abundantfrom swinebovineetcand can be fabricated into the desired sizes of vascular patches NARRATIVE Although biological and synthetic patches are broadly used in clinical practice for arterial and venous repair or reconstructionthere remain some shortcomingsThe purpose of this Phase I SBIR is to validate the pulmonary visceral pleura for arterial and venous patches for vascular repair or reconstruction as a superior biomaterial