Impermeable inner shell for a breast implant

Abstract

An implantable device includes a first sealed flexible shell configured for implantation within a breast of a human subject, an elastic filler material contained within the first sealed flexible shell, and a second sealed flexible, inelastic shell, which is disposed within the elastic filler material inside the first sealed flexible shell and is inflated with a volume of gas. The second shell includes a material selected such that an amount of the gas escaping from the second shell does not exceed 10−8 Torr-liter/second when the gas pressure inside the second shell is 250 mbar higher than the gas pressure outside the second shell.

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         12 . A method for manufacturing an implantable device, the method comprising:
 providing a first sealed flexible shell configured for implantation within a breast of a human subject;   filling the first sealed flexible shell with an elastic filler material;   providing a second sealed flexible, inelastic shell which is impermeable to a gas, such that an amount of the gas escaping from the second shell does not exceed 10−8 Torr-liter/second when the gas pressure inside the second shell is 250 mbar higher than the gas pressure outside the second shell;   disposing the second shell within the elastic filler material inside the first sealed flexible shell; and   inflating the second shell with a volume of the gas;   wherein the second sealed flexible, inelastic shell comprises a first composite comprising polyamide and polyurethane, and a second composite comprising polyurethane, ethylene vinyl alcohol and polyethylene.   
     
     
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         14 . The method according to  claim 12 , wherein providing a second sealed flexible shell impermeable to a gas comprises depositing at least one coating impermeable to the gas on the second shell. 
     
     
         15 . The method according to  claim 14 , wherein the coating comprises graphene oxide, and wherein depositing the coating comprises:
 providing graphene oxide as a suspension in a liquid;   applying the liquid on an outer surface of the second shell; and   allowing the liquid to dry.   
     
     
         16 . The method according to  claim 14 , wherein the coating comprises aluminum oxide, and wherein depositing the coating comprises:
 providing aluminum oxide as a suspension in a liquid;   applying the liquid on an outer surface of the second shell; and   allowing the liquid to dry.   
     
     
         17 . The method according to  claim 14 , wherein the coating comprises titanium oxide, and wherein depositing the coating comprises:
 providing titanium oxide as a suspension in a liquid;   applying the liquid on an outer surface of the second shell; and   allowing the liquid to dry.   
     
     
         18 . The method according to  claim 12 , wherein filling the first sealed flexible shell comprises filling the shell with silicone gel. 
     
     
         19 . The method according to  claim 12 , wherein inflating the second sealed flexible shell comprises inflating the shell with air. 
     
     
         20 . The method according to  claim 12 , wherein inflating the second sealed flexible shell comprises inflating the shell with argon.