Multilayer Fibrous Polymer Scaffolds, Methods of Production and Methods of Use

Abstract

Fibrous polymer scaffolds and methods of manufacture are provided. The scaffolds can be formed of multiple layers and the extent and direction of alignment of each layer can be controlled. Efficient fabrication systems and methods for producing such scaffolds include apparatuses and processes are also provided. Kits including the fibrous polymer scaffolds and methods for implanting such scaffolds are also provided.

What is claimed is: 
     
         1 . A fibrous polymer scaffold, comprising a first set of polymer fibers, the first set of polymer fibers comprising:
 poly(ethylene glycol) or poly(propylene glycol); and   a polyester material selected from poly(L-lactide), poly(D,L-lactide), poly(L-lactic acid), poly(D,L-lactic acid), poly(glycolic acid), poly(glycolide), poly(caprolactone), poly(dioxanone), polyhydroxyalkanoates, combinations of any of the foregoing, copolymers of any of the foregoing, and blends of any of the foregoing;   wherein the poly(ethylene glycol) or the poly(propylene glycol) is present in an amount of 0.1%-10% of the total weight of the polymer fibers.   
     
     
         2 . The fibrous polymer scaffold of  claim 1 , comprising a second set of polymer fibers, the second set of polymer fibers comprising:
 poly(ethylene glycol) or poly(propylene glycol); and   a polyester material selected from poly(L-lactide), poly(D,L-lactide), poly(L-lactic acid), poly(D,L-lactic acid), poly(glycolic acid), poly(glycolide), poly(caprolactone), poly(dioxanone), polyhydroxyalkanoates, combinations of any of the foregoing, copolymers of any of the foregoing, and blends of any of the foregoing;   wherein the poly(ethylene glycol) or the poly(propylene glycol) is present in an amount of 0.1%-10% of the total weight of the second set of polymer fibers.   
     
     
         3 . The fibrous polymer scaffold of  claim 1 , wherein the scaffold has a shape selected from a membrane and a conduit. 
     
     
         4 . The fibrous polymer scaffold of  claim 1 , wherein the polymer fibers are randomly oriented. 
     
     
         5 . The fibrous polymer scaffold of  claim 1 , wherein the polymer fibers are aligned. 
     
     
         6 . The fibrous polymer scaffold of  claim 5 , wherein the polymer fibers are longitudinally aligned. 
     
     
         7 . The fibrous polymer scaffold of  claim 5 , wherein the polymer fibers are circumferentially aligned. 
     
     
         8 . The fibrous polymer scaffold  claim 1 , comprising a salt selected from NaCl, K 2 HPO 4 , KIO 3 , KCl, MgSO 4 , MgCl 2 , NaHCO 3 , CaCl 2 , sodium acetate, salt of acetic acid, salt of ascorbic acid, salt of citric acid, salt of lactic acid, salt of glycolic acid, and combinations of any of the foregoing. 
     
     
         9 . The fibrous polymer scaffold of  claim 1 , further comprising cells seeded between the polymer fibers. 
     
     
         10 . The fibrous polymer scaffold of  claim 9 , wherein the cells are human cells. 
     
     
         11 . The fibrous polymer scaffold of  claim 1 , further comprising one or more molecules covalently attached to the scaffold. 
     
     
         12 . The fibrous polymer scaffold of  claim 11 , wherein the molecules are directly attached to the scaffold. 
     
     
         13 . The fibrous polymer scaffold of  claim 11 , wherein the molecules are attached to the scaffold through a linker selected from di-amino poly(ethylene glycol), poly(ethylene glycol) and a combination of the two. 
     
     
         14 . The fibrous polymer scaffold of  claim 11 , wherein the molecules are capable of either covalently or non-covalently attaching to an extracellular matrix component, a growth factor, a differentiation factor or a combination of any of the foregoing. 
     
     
         15 . The fibrous polymer scaffold of  claim 11 , wherein the molecules are biomolecules. 
     
     
         16 . The fibrous polymer scaffold of  claim 14 , wherein the extracellular matrix component is selected from laminin, collagen, fibronectin, elastin, vitronectin, fibrinogen, polylysine and combinations of any of the foregoing. 
     
     
         17 . The fibrous polymer scaffold of  claim 14 , wherein the growth or differentiation factor is selected from acidic fibroblast growth factor, basic fibroblast growth factor, nerve growth factor, brain-derived neurotrophic factor, insulin-like growth factor, platelet derived growth factor, transforming growth factor beta, vascular endothelial growth factor, epidermal growth factor, keratinocyte growth factor, stromal cell derived factor, sonic hedgehog, bone morphogenic proteins, notch ligands, Wnt and combinations of any of the foregoing. 
     
     
         18 . A fibrous polymer scaffold, comprising a first layer of polymer fibers, the fibers comprising poly(L-lactic acid) and poly(propylene glycol), wherein poly(propylene glycol) is present in an amount of 0.1%-10% of the total weight of the polymer fibers. 
     
     
         19 . A kit for the repair of wounds, surgical incisions, or biopsies comprising a fibrous polymer scaffold according to  claim 1  and instructions for using the scaffold to promote the regeneration of at least one anatomical biological component. 
     
     
         20 . The kit of  claim 19 , wherein the anatomical biological component is selected from abdominal wall, amniotic sac, bladder, blood vessels, brain, cardiac tissue, fascia, gingival tissue, intestine, ligaments, meningeal tissue, mucous, membranes, muscle, nerves, skin, spinal cord, stomach and tendons.