Alloplastic injectable dermal filler and method of use thereof

Abstract

A composition comprising an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent is provided. A method of making a composition comprising an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent, said method comprising admixing a biocompatible and pliable material with a physiologically acceptable suspending agent, is also provided. A method of augmenting soft tissue to provide long-term reduction of a skin defect, said method comprising stimulating collagen beneath the skin defect is further provided. In an embodiment of the method of augmenting soft tissue, the stimulation of collagen production is effected by injecting into the deep reticular dermis an a dermal filler, said dermal filler being an alloplastic injectable suspension and comprising a biocompatible and pliable material and a physiologically acceptable suspending agent.

What is claimed is: 
     
         1 . A composition comprising:
 an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent;   wherein the biocompatible and pliable material is a copolymer of an unsubstituted acrylate monomer and a substituted acrylate monomer.   
     
     
         2 . The composition of  claim 1 , wherein the substituted acrylate monomer is substituted with a methyl group. 
     
     
         3 . The composition of  claim 1 , wherein the substituted acrylate monomer is substituted with a hydrocarbon chain of two, three, four or five carbons. 
     
     
         4 . The composition of  claim 1 , wherein the substituted acrylate monomer is substituted with a halogen group. 
     
     
         5 . The composition of  claim 1 , wherein the substituted acrylate monomer is substituted with a nitrile group. 
     
     
         6 . The composition of  claim 1 , wherein the biocompatible and pliable material is an acrylate/methacrylate copolymer. 
     
     
         7 . The composition of  claim 6 , wherein the acrylate/methacrylate copolymer is a solid. 
     
     
         8 . The composition of  claim 7 , wherein the solid is a powder. 
     
     
         9 . The composition of  claim 7 , wherein the solid is a non-porous microbead. 
     
     
         10 . The composition of  claim 7 , wherein the solid is a microsphere. 
     
     
         11 . The composition of  claim 7 , wherein the solid has a diameter of about 10 μ to about 100 μ. 
     
     
         12 . The composition of  claim 7 , wherein the physiologically acceptable suspending agent is resorbable. 
     
     
         13 . The composition of  claim 12 , wherein the physiologically acceptable suspending agent is a buffered physiological solution. 
     
     
         14 . The composition of  claim 12 , wherein the physiologically acceptable suspending agent comprises cross-linked sodium hyaluronate. 
     
     
         15 . The composition of  claim 12 , wherein the physiologically acceptable suspending agent comprises a non cross-linked sodium hyaluronate. 
     
     
         16 . The composition of  claim 12 , wherein the physiologically acceptable suspending agent comprises collagen. 
     
     
         17 . The composition of  claim 16 , wherein the collagen is derived from an animal. 
     
     
         18 . The composition of  claim 16 , wherein the collagen is derived from a bird. 
     
     
         19 . The composition of  claim 16 , wherein the collagen is genetically engineered. 
     
     
         20 . The composition of  claim 12 , further comprising a local anesthetic. 
     
     
         21 . A method of making a composition comprising an alloplastic injectable suspension for use as a dermal filler comprising a biocompatible and pliable material and a physiologically acceptable suspending agent, said method comprising admixing a biocompatible and pliable material with a physiologically acceptable suspending agent;
 wherein the biocompatible and pliable material is an acrylate/methacrylate copolymer.   
     
     
         22 . The method of  claim 21 , wherein the acrylate/methacrylate copolymer is a solid. 
     
     
         23 . The method of  claim 22 , wherein the solid is a powder. 
     
     
         24 . The method of  claim 22 , wherein the solid is a non-porous microbead. 
     
     
         25 . The method of  claim 22 , wherein the solid is a microsphere. 
     
     
         26 . The method of  claim 22 , wherein the solid has a diameter of about 10 μto about 100 μ. 
     
     
         27 . The method of  claim 21 , wherein the physiologically acceptable suspending agent is resorbable. 
     
     
         28 . The method of  claim 27 , wherein the physiologically acceptable suspending agent is a buffered physiological solution. 
     
     
         29 . The method of  claim 27 , wherein the physiologically acceptable suspending agent comprises cross-linked sodium hyaluronate. 
     
     
         30 . The method of  claim 27 , wherein the physiologically acceptable suspending agent comprises a non cross-linked sodium hyaluronate. 
     
     
         31 . The method of  claim 27 , wherein the physiologically acceptable suspending agent comprises collagen. 
     
     
         32 . The method of  claim 31 , wherein the collagen is derived from an animal. 
     
     
         33 . The method of  claim 31 , wherein the collagen is derived from a bird. 
     
     
         34 . The method of  claim 31 , wherein the collagen is genetically engineered. 
     
     
         35 . A method of augmenting soft tissue to provide long-term reduction of a skin defect, said method comprising stimulating collagen production, fibroblast production, fibrocyte production or production of any combination thereof, beneath the skin defect. 
     
     
         36 . The method of  claim 35 , wherein the stimulation of collagen production fibroblast production, fibrocyte production or production of any combination thereof is effected by injecting into the deep reticular dermis a dermal filler, said dermal filler being an alloplastic injectable suspension and comprising a biocompatible and pliable material and a physiologically acceptable suspending agent. 
     
     
         37 . The method of  claim 36 , wherein the dermal filler is injected below the skin defect at a junction of the dermis and subcutaneous fat. 
     
     
         38 . The method of  claim 36 , wherein the injected dermal filler produces little immunologic response in the host tissue or no immunologic response in the host tissue. 
     
     
         39 . The method of  claim 35 , wherein the skin defect is a result of loss of collagen and hyaluronic acid in the skin during the aging process. 
     
     
         40 . The method of  claim 35 , wherein the skin defect is a result of premature aging, said premature aging caused by overexposure to sunlight, overexposure to environmental pollutants, smoking tobacco products, exposure to cigarette smoke, poor nutrition and skin disorders. 
     
     
         41 . The method of  claim 35 , wherein the skin defect is a dynamic wrinkle, a fine wrinkles or a static wrinkle. 
     
     
         42 . The method of  claim 41 , wherein the dynamic wrinkle is a forehead crease, a brow burrow or an eye line (crow's feet). 
     
     
         43 . The method of  claim 41 , wherein the static wrinkle is a skin fold wrinkle resulting from sagging skin. 
     
     
         44 . The method of  claim 35 , wherein the skin defect is a medical condition selected from the group consisting of an acne scar, a surgical scar, a large pore and a soft tissue contour defect. 
     
     
         45 . The method of  claim 35 , wherein the long-term reduction of the skin defect is of a duration of at least one year. 
     
     
         46 . The method of  claim 35 , wherein the long-term reduction of the skin defect is of a duration of from at least one year to about five years. 
     
     
         47 . The method of  claim 35 , wherein the long-term reduction of the skin defect is of a duration from about five years to about ten years. 
     
     
         48 . The method of  claim 35 , wherein the long-term reduction of the skin defect is of a duration from about ten years or longer.