Composite material for tissue restoration

Abstract

A composite material can include a gel and at least one nanostructure disposed within the gel. A method for healing a soft tissue defect can include applying a composite material to a soft tissue defect, wherein the composite material includes a gel and a nanostructure disposed within the gel. A method for manufacturing a composite material for use in healing soft tissue defects can include providing a gel and disposing nanofibers within the gel.

What is claimed is: 
     
         1 . An injectable scaffold complex comprising a polymeric fiber or fragments thereof having a mean diameter of from about 100 nm to about 8000 nm covalently linked to a hydrogel material,
 wherein the hydrogel material is capable of forming a network,   wherein the ratio of polymeric fiber to hydrogel material is from about 1:10 to about 10:1 on a component-mass basis or from about 1 to 50 mg/mL on a concentration basis.   
     
     
         2 . The scaffold complex of  claim 1 , wherein the scaffold complex is capable of being injected through a 21 gauge or smaller gauge needle. 
     
     
         3 . The scaffold complex of  claim 1 , wherein the scaffold complex is capable of forming an elastic gel prior to, during, or following injection. 
     
     
         4 . The scaffold complex of  claim 1 , wherein the scaffold complex is isotropic. 
     
     
         5 . The scaffold complex of  claim 1 , wherein the polymeric fiber or fragments thereof comprise a mean length of less than 500 micrometers. 
     
     
         6 . The scaffold complex of  claim 1 , wherein the scaffold can form a gel comprising an arbitrary volumetric geometry. 
     
     
         7 . The scaffold complex of  claim 1 , wherein the polymeric fiber or fragments thereof are uniformly dispersed. 
     
     
         8 . The scaffold complex of  claim 1 , wherein the hydrogel material is bonded to the outer surface of the polymeric fiber. 
     
     
         9 . The scaffold complex of  claim 1 , further comprising a polymeric fiber or fragments thereof non-covalently linked to a hydrogel material,
 wherein the hydrogel material is capable of forming a network,   wherein the non-covalent link comprises (i) electrostatic interactions and/or (ii) hydrogen-bonding.   
     
     
         10 . The scaffold complex of  claim 1 , wherein the polymeric fiber or fragments thereof comprises an electrospun fiber. 
     
     
         11 . The scaffold complex of  claim 1 , wherein the polymeric fiber or fragments thereof comprises a synthetic polymeric material comprising a poly(lactic-co-glycolic acid), poly(lactic acid), and/or a polycaprolactone, or a combination or derivatives thereof; or a biological polymeric material selected from the group consisting of a silk, collagen, elastin, hyaluronic acid, chitosan, a derivative thereof, or a combination thereof. 
     
     
         12 . The scaffold complex of  claim 1 , wherein the hydrogel material comprises a poly(ethylene glycol), a collagen, a dextran, an elastin, an alginate, a hyaluronic acid, a poly(vinyl alcohol), a derivative thereof, or a combination thereof. 
     
     
         13 . The scaffold complex of  claim 1 , wherein the hydrogel material comprises a processed tissue extracellular matrix,
 wherein the processed tissue extracellular matrix is derivable from an adipose tissue.   
     
     
         14 . The scaffold complex of  claim 1 , wherein the polymeric fiber or fragments thereof comprise a synthetic polymeric material comprising a poly(lactic-co-glycolic acid), poly(lactic acid), a polycaprolactone, or a combination or derivative thereof, and wherein the hydrogel material comprises a poly(ethylene glycol), a collagen, a dextran, an elastin, an alginate, a hyaluronic acid, a poly(vinyl alcohol), a derivative thereof, or a combination thereof. 
     
     
         15 . The scaffold complex of  claim 1 , comprising a plurality of pores present on a surface of the scaffold complex and within the scaffold complex,
 wherein the pores are present at a concentration of at least about 50 pores per square centimeters of the surface,   and wherein at least 80% of the pores have an average pore diameter of at least 5 micrometers.   
     
     
         16 . A medical device for retaining tissue shape in a subject undergoing a surgical procedure, comprising the scaffold complex of  claim 1  in an amount effective to provide for the retention of a tissue shape when administered to the subject. 
     
     
         17 . A method for reducing or reversing a tissue defect resulting from trauma, surgical intervention, or an age-associated disease, disorder or condition, comprising distending the tissue and/or the tissue defect,
 wherein distending the tissue comprises injecting into the tissue and/or the tissue defect an injectable scaffold complex comprising a polymeric fiber or fragments thereof having a mean diameter of from about 100 nm to about 8000 nm covalently linked to a hydrogel material,   wherein the hydrogel material is capable of forming a network,   wherein the ratio of polymeric fiber to hydrogel material is from about 1:10 to about 10:1 on a component-mass basis or from about 1 to 50 mg/mL on a concentration basis,   wherein the injectable scaffold complex is injected into the tissue to thereby distend it.   
     
     
         18 . The method of  claim 17 , wherein the injectable scaffold complex is injected for cosmetic or reconstructive purposes. 
     
     
         19 . A method for promoting tissue ingrowth in a target tissue present in a human subject, comprising implanting an effective amount of the scaffold complex of  claim 1  into the target tissue. 
     
     
         20 . A method for preparing an implant for tissue or cartilage repair, the method comprising the steps of:
 providing an acellular, three-dimensional scaffold comprising polymeric fibers oriented to produce a plurality of pores,   wherein at least a portion of the polymeric fibers are crosslinked to a hydrogel-forming network to form a crosslinked composite;   and reacting or stabilizing the complex to form a stabilized implant, thereby preparing the implant.