Implant with elastomeric membrane and methods of fabrication thereof

A method of forming an implant for volumetrically altering, replacing, expanding, or augmenting body tissues, the method comprising:

• providing a preformed shell formed from at least one cured elastomeric layer, the preformed shell comprising an outer surface, an inner surface, and an opening for accessing an interior volume of the preformed shell;
• placing the preformed shell on a mandrel to expand the preformed shell to an expanded state in which the interior volume of the preformed shell is greater than a volume of the preformed shell at a time of forming the preformed shell;
• while the preformed shell is on the mandrel, forming an outer zone comprising at least one outer elastomeric layer on at least a portion of the outer surface of the preformed shell, while the preformed shell is in the expanded state, to form a multi-zone shell;
• placing the multi-zone shell on the mandrel in an inverted orientation, in which the outer zone of the multi-zone shell contacts the mandrel;
• forming an inner zone comprising at least one inner elastomeric layer on at least a portion of the inner surface of the multi-zone shell, while the multi-zone shell is on the mandrel and in the expanded state;
• reducing the interior volume of the multi-zone shell by removing the multi-zone shell from the mandrel, thereby contracting the at least one outer elastomeric layer and the at least one inner elastomeric layer, and causing texturing of the at least one outer elastomeric layer and the at least one inner elastomeric layer;
• and
• forming the implant by enclosing the shell to form at least one chamber.

An implant for volumetrically altering, replacing, expanding, or augmenting tissues, comprising:

• an enclosed or partially enclosed elastomeric shell formed from a plurality of laminated elastomeric layers, the elastomeric shell defining an interior volume;
• and
• a cohesive gel disposed in the interior volume of the elastomeric shell,
• wherein the elastomeric shell comprises:
• a preformed shell comprising at least one elastomeric layer, the preformed shell having an inner surface and an outer surface;
• an outer zone comprising at least one outer elastomeric layer covering at least a portion of the outer surface of the preformed shell;
• and
• an inner zone comprising at least one inner elastomeric layer covering at least a portion of the inner surface of the preformed shell,
• wherein a volume enclosed by the outer zone and the inner zone at the time of forming the outer zone and the inner zone is greater than a volume of the preformed shell at a time of forming the preformed shell.