Glass Composites for Tissue Augmentation, Biomedical and Cosmetic Applications

Abstract

Compositions and methods for glass composites suitable for tissue augmentation, biomedical, and cosmetic applications are provided. The glass microsphere component of the composites are biologically inert, non-reactive and act as a nearly permanent tissue filler. One embodiment provides a tissue augmentation composite containing an effective amount of solid glass microspheres, hollow glass microspheres, porous wall hollow glass microspheres, or combinations thereof with a suitable biocompatible matrix to serve as a bulking agent when injected into a patient. The compositions can be used for soft or hard tissue augmentation as well as delivery of cargos on demand.

1 . A composite material comprising:
 (a) 50% vol/vol or greater of long lasting silica-based glass microspheres, wherein the silica-based glass microspheres are selected from the group consisting of hollow glass microspheres, porous wall hollow glass microspheres, or a combination thereof; and   (b) a biocompatible matrix,   wherein the silica-based glass microspheres flow readily, and induce little or no inflammatory response when administered to the subject.   
     
     
         2 . (canceled) 
     
     
         3 . The composite material of  claim 1 , wherein the glass microsphere components have a diameter of 10 mm to 100 μm. 
     
     
         4 . The composite material of  claim 1 , where the matrix component comprises a gelling agent. 
     
     
         5 . The composite material of  claim 1 , wherein the microsphere components are coated with a coating agent to provide controlled release of a substance loaded into the microspheres. 
     
     
         6 . The composite material of  claim 1 , wherein the microsphere components are gated with a gating agent to provide controlled release of a substance loaded in the microspheres. 
     
     
         7 . The composite material of  claim 6 , wherein the gating agent is a polymer. 
     
     
         8 . The composite material of  claim 6 , wherein the gating agent is selected from the group consisting of dextran, colloidal starch, polymerized fibrin, and a polyvinylpyrrolidone. 
     
     
         9 . The composite material of  claim 1 , wherein the hollow glass microsphere components are loaded with a cargo selected from the group consisting of a therapeutic drug, biological cell, biological molecule, or colorant. 
     
     
         10 . A method for augmenting tissue in a subject in need thereof comprising: administering the composite of  claim 1  to the subject in an amount effective to augment tissue in the subject. 
     
     
         11 . The method of  claim 10 , wherein the tissue is soft or hard tissue. 
     
     
         12 . The method of  claim 10 , wherein the tissue augmentation is done to treat contour deficiencies in the subject selected from the group consisting of frown lines, worry lines, wrinkles, crow's feet, marionette lines, stretch marks, and tissue volume loss resulted from injury, wound, bite, surgery, or accident. 
     
     
         13 . The method of  claim 10 , wherein the tissue augmentation is done to treat vocal cord injury, defect or disease. 
     
     
         14 . The method of  claim 10 , wherein the tissue augmentation is done to treat a sphincteric muscle. 
     
     
         15 . The method of  claim 14 , wherein the sphincteric muscle is the urinary bladder sphincter or the upper esophageal sphincteric muscle. 
     
     
         16 . The method of  claim 10 , wherein the tissue augmentation is done to treat a bone fracture, bone defect, bone loss, or bone erosion. 
     
     
         17 . A method for implanting a composite into a subject in need thereof comprising: administering the composite of  claim 1  to the subject in an amount effective to provide, restore or modify the vibratory characteristics of the appropriate tissue in the subject. 
     
     
         18 . The method of  claim 17 , wherein the tissue is one or both vocal folds. 
     
     
         19 . The method of  claim 17 , wherein the tissue is the superficial layer of the lamina propria of one or both vocal folds. 
     
     
         20 . A method for delivery of a therapeutic agent to a subject in need thereof comprising: administering a composite comprising 50% vol/vol or greater of silica-based hollow glass microspheres loaded with a therapeutic agent and, a biologically