Multi-Layer Vascular Prosthesis

Abstract

A vascular prosthesis comprising a tubular support structure having an outer surface and an internal lumen therethrough, the support structure comprising a base material, which can comprise natural or synthetic materials, the internal lumen surface including an extracellular matrix (ECM) layer that includes at least one ECM material, wherein, when said vascular prosthesis is deployed proximate damaged cardiovascular tissue, the prosthesis induces modulated healing of the damaged tissue. In some embodiments, the support member outer surface also includes an ECM layer.

What is claimed is: 
     
         1 . A vascular prosthesis, comprising:
 a tubular support structure having an outer surface and an internal lumen therethrough, said internal lumen having a first surface, said support structure comprising a base material,   said internal lumen first surface including a first extracellular matrix (ECM) layer comprising an ECM composition, said ECM composition including at least one ECM material from a mammalian tissue source,   wherein, when said vascular prosthesis is deployed proximate damaged cardiovascular tissue, said prosthesis induces modulated healing of said damaged tissue.   
     
     
         2 . The vascular prosthesis of  claim 1 , wherein said first ECM layer comprises a first ECM composition coating. 
     
     
         3 . The vascular prosthesis of  claim 1 , wherein said first ECM layer comprises a first ECM composition sheet member. 
     
     
         4 . The vascular prosthesis of  claim 1 , wherein said support member outer surface includes a second ECM layer, said second ECM layer comprising said ECM composition. 
     
     
         5 . The vascular prosthesis of  claim 4 , wherein said second ECM layer comprises a second ECM composition coating. 
     
     
         6 . The vascular prosthesis of  claim 4 , wherein said second ECM layer comprises a second ECM composition sheet member. 
     
     
         7 . The vascular prosthesis of  claim 1 , wherein said support structure comprises a synthetic material selected from the group consisting of Dacron®, Orlon®, Fortisan®, nylon, knitted polypropylene, microporous expanded-polytetrafluoroethylene, Dacron® reinforced silicone rubber, and polyester. 
     
     
         8 . The vascular prosthesis of  claim 1 , wherein said support structure comprises a natural material selected from the group consisting of processed sheep dermal collagen, crosslinked bovine pericardium, and preserved human dura. 
     
     
         9 . The vascular prosthesis of  claim 1 , wherein said support structure comprises a metal structure selected from the group consisting of tantalum gauze and stainless mesh. 
     
     
         10 . The vascular prosthesis of  claim 1 , wherein said ECM material is selected from the group consisting of small intestine submucosa (SIS), urinary bladder submucosa (UBS), urinary basement membrane (UBM), liver basement membrane (LBM), stomach submucosa (SS), mesothelial tissue, subcutaneous extracellular matrix, large intestine extracellular matrix, placental extracellular matrix, ornamentum extracellular matrix, heart extracellular matrix and lung extracellular matrix. 
     
     
         11 . The vascular prosthesis of  claim 1 , wherein said ECM material comprises a decellularized ECM material. 
     
     
         12 . The vascular prosthesis of  claim 1 , wherein said ECM material includes at least one supplemental biologically active agent. 
     
     
         13 . The vascular prosthesis of  claim 12 , wherein said biologically active agent comprises a growth factor selected from the group consisting of a platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor-α (TGF-α), transforming growth factor-β (TGF-β), fibroblast growth factor-2 (FGF-2), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), hepatocyte growth factor (HGF), insulin-like growth factor (IGF), nerve growth factor (NGF), platelet derived growth factor (PDGF), tumor necrosis factor-α (TNA-α), and placental growth factor (PLGF). 
     
     
         14 . The vascular prosthesis of  claim 12 , wherein said biologically active agent comprises a cell selected from the group consisting of a human embryonic stem cell, fetal cardiomyocyte, myofibroblast, mesenchymal stem cell, autotransplanted expanded cardiomyocytes, adipocyte, totipotent cell, pluripotent cell, blood stem cell, myoblast, adult stem cell, bone marrow cell, mesenchymal cell, embryonic stem cell, parenchymal cell, epithelial cell, endothelial cell, mesothelial cell, fibroblast, osteoblast, chondrocyte, exogenous cell, endogenous cell, hematopoietic stem cell, bone-marrow derived progenitor cell, myocardial cell, skeletal cell, fetal cell, undifferentiated cell, multi-potent progenitor cell, unipotent progenitor cell, monocyte, cardiac myoblast, skeletal myoblast, macrophage, capillary endothelial cell, xenogenic cell, allogenic cell and post-natal stem cell. 
     
     
         15 . The vascular prosthesis of  claim 12 , wherein said biologically active agent comprises an active agent selected from the group consisting of a collagen (types I-V), proteoglycans, glycosaminoglycans (GAGs), glycoproteins, cytokines, cell-surface associated proteins, cell adhesion molecules (CAMs), endothelial ligands, matrikines, cadherins, immuoglobins, fibril collagens, non-fibrallar collagens, basement membrane collagens, multiplexins, small-leucine rich proteoglycans, decorins, biglycans, fibromodulins, keratocans, lumicans, epiphycans, heparin sulfate proteoglycans, perlecans, agrins, testicans, syndecans, glypicans, serglycins, selectins, lecticans, aggrecans, versicans, neurocans, brevicans, cytoplasmic domain-44 (CD-44), macrophage stimulating factors, amyloid precursor proteins, heparins, chondroitin sulfate B (dermatan sulfate), chondroitin sulfate A, heparin sulfates, hyaluronic acids, fibronectins, tenascins, elastins, fibrillins, laminins, nidogen/enactins, fibulin I, finulin II, integrins, transmembrane molecules, thrombospondins, ostepontins, and angiotensin converting enzymes (ACE). 
     
     
         16 . The vascular prosthesis of  claim 12 , wherein said biologically active agent comprises a pharmacological agent. 
     
     
         17 . The vascular prosthesis of  claim 12 , wherein said pharmacological agent is selected from the group consisting of antibiotics, antifungal agents, anti-viral agents, anti-pain agents, anesthetics, analgesics, steroidal anti-inflammatories, non-steroidal anti-inflammatories, anti-neoplastics, anti-spasmodics, modulators of cell-extracellular matrix interactions, proteins, hormones, enzymes and enzyme inhibitors, anticoagulants, antithrombic agents, DNA, RNA, modified DNA and RNA, NSAIDs, inhibitors of DNA, polypeptides, oligonucleotides, polynucleotides, nucleoproteins, and vasodilating agents. 
     
     
         18 . The tissue prosthesis of  claim 16 , wherein said pharmacological agent comprises a HMG-CoA reductase inhibitor. 
     
     
         19 . The tissue prosthesis of  claim 18 , wherein said HMG-CoA reductase inhibitor is selected from the group consisting of atorvastatin, cerivastatin, fluvastatin, lovastatin, mevastatin, pitavastatin, pravastatin, rosuvastatin and simvastatin.