Soft Prosthesis Shell Texturing Method

Abstract

A method of texturing a soft prosthetic implant shell, such as a silicone breast implant shell. A soft prosthetic implant with a textured external surface layer of silicone elastomer and having an open-cell structure is made by adhering and then dissolving round salt crystals. The resulting roughened surface has enhanced physical properties relative to surfaces formed with angular salt crystals. An implant having such a textured external surface layer is expected to help prevent capsular contraction, to help prevent scar formation, and to help in anchoring the implant within the body.

1 . A process for forming a soft prosthetic implant, comprising:
 forming a flexible shell;   adhering on the exterior of the flexible shell a substantially even distribution of rounded salt particles;   curing the flexible shell with the rounded salt particles adhered thereto; and   exposing the flexible shell to an aqueous solvent for the rounded salt particles for a sufficient amount of time to dissolve the rounded salt particles and form an open-pored structure on the exterior of the flexible shell.   
     
     
         2 . The process of  claim 1 , wherein the rounded salt particles are sodium chloride crystals. 
     
     
         3 . The process of  claim 1 , wherein the flexible shell is formed of a silicone elastomer. 
     
     
         4 . The process of  claim 1  further comprising the step of applying a tack coat layer to the flexible shell prior to the step of adhering. 
     
     
         5 . The process of  claim 1 , further comprising the step of applying an overcoat to the distribution of rounded salt particles prior to the step of curing. 
     
     
         6 . The process of  claim 1 , wherein the rounded salt particles have a maximum particle size range selected from a group of ranges consisting of (1) a range between about 180 microns and about 425 microns, (2) a range between about 425 microns and about 850 microns, and (3) a range between about 850 microns and about 1450 microns. 
     
     
         7 . The process of  claim 6  wherein about 90% of the rounded salt particles are in the selected particle size range. 
     
     
         8 . The process of  claim 1 , wherein the prosthetic implant is a breast implant and the flexible shell is shaped accordingly. 
     
     
         9 . The process of  claim 1 , wherein the step of forming the flexible shell comprises dipping a mandrel into a liquid dispersion of an elastomeric material. 
     
     
         10 . The process of  claim 1 , wherein the step of forming the flexible shell comprises rotationally molding the shell. 
     
     
         11 . The process of  claim 1 , wherein the step of adhering comprises dipping the flexible shell into a liquid containing the rounded salt particles. 
     
     
         12 . The process of  claim 11 , further comprising the step of applying a tack coat layer onto the flexible shell prior to the step of dipping the flexible shell into a liquid containing the rounded salt particles.