Artificial breast implant provided on the surface threof with silicon open cell foam layer, and method for producing the same

Abstract

Disclosed are an artificial breast implant in which the surface thereof is formed or modified with a silicone open cell (open pore) foam layer, and a method for producing the same. More specifically, disclosed are an artificial breast implant that has a surface including an open cell foam layer made of silicone and thus minimizes side effects such as in vivo rejection, which may occur after implantation of the implant into the body, in particular, the occurrence of capsular contracture to achieve superior biocompatibility and safety, and a method for producing the same.

1 . An artificial breast implant provided on the surface thereof with a silicone open cell foam layer, the surface of which is formed or modified with a silicone open cell (pore) foam layer. 
     
     
         2 . The artificial breast implant according to  claim 1 , wherein the open cell (open pore) foam layer has a three-dimensional net structure with a uniform or non-uniform thickness. 
     
     
         3 . A method for producing an artificial breast implant provided at the surface thereof with a silicone open cell foam layer, comprising:
 a silicone dipping operation of dipping a breast-shaped mold in a silicone solution to obtain an artificial breast shell;   a drying and curing operation of drying an artificial breast shell adhered to the mold using a drier, followed by curing to obtain a silicone artificial breast shell;   an open cell formation operation of forming an open cell foam layer on the surface of the dried and cured shell;   an artificial breast shell acquisition operation of forming an aperture on the bottom of the artificial breast shell adhered to the mold and provided with the open cell foam layer and removing the artificial breast shell from the mold; and   an implant formation operation of adhering a silicone film including a leakage prevention film to the aperture to fill the aperture.   
     
     
         4 . The method according to  claim 3 , wherein the formation of the open cell foam layer includes:
 dipping the dried and cured mold provided with the shell in a silicone solution and taking out the mold;   scattering or spraying a solid particle or powder with an appropriate size to the surface of the shell such that the silicone solution film loses flowability; and   scattering or spraying a solid particle or powder to the surface of the shell.   
     
     
         5 . The method according to  claim 4 , wherein the solid particle or powder is not dissolved in the silicone solution and does not affect physical properties of the silicone solution, and is dissolved in a solvent and removed. 
     
     
         6 . The method according to  claim 5 , wherein the solid particle or powder is sodium chloride, ammonium carbonate, ammonium phosphate, or ammonium chloride. 
     
     
         7 . The method according to  claim 5 , wherein the solvent is water. 
     
     
         8 . The method according to  claim 4 , wherein the organic solvent is readily miscible with the silicone solution. 
     
     
         9 . The method according to  claim 8 , wherein the organic solvent is benzene, toluene, xylene or a derivative thereof. 
     
     
         10 . The method according to  claim 9 , wherein the organic solvent is xylene. 
     
     
         11 . The method according to  claim 4 , wherein, in the formation of the open cell foam layer, an open cell foam layer with a desired thickness is formed by controlling the concentration of silicone solution, the size of solid particles or powders, and organic solvent treatment speed. 
     
     
         12 . The method according to  claim 4 , wherein an open cell foam layer with a desired thickness is formed by repeating the formation of the open cell foam layer. 
     
     
         13 . The method according to  claim 4 , wherein the formation of the open cell foam layer further includes:
 removing nips (post-processing) to control the thickness of the formed open cell foam layer or to realize excellent appearance.   
     
     
         14 . The method according to  claim 4 , wherein, in the formation of the open cell foam layer, the treated solid particle or powder for formation of the open cell is removed by directly or indirectly treating the artificial breast shell provided with an open cell with water vapor. 
     
     
         15 . The method according to  claim 4 , wherein the formation of the open cell foam layer further includes:
 a drying and curing operation of drying and curing the formed open cell foam layer.   
     
     
         16 . The method according to  claim 15 , wherein the drying is carried out by completely evaporating the organic solvent at 30° C. in an oven and the curing is carried out by curing the silicone solution present on the dried artificial breast mold in an oven at 170° C. for three hours. 
     
     
         17 . The method according to  claim 15 , further comprising:
 rubbing treating the artificial breast shell provided with dried and cured open cell foam layer to remove the solid particle or powder.   
     
     
         18 . The method according to  claim 15 , further comprising:
 heating and high-pressure vapor treating the artificial breast shell provided with dried and cured open cell foam layer in the presence of 140° C. water and 1.4 atm vapor, for about 30 hours, to remove the solid particle or powder.