Implant with a visual indicator of a barrier layer
AssigneeEstablishment Labs S.A.
InventorsRolando Mora, Salvador Dada, Juan Jose Chacon
Life of this patent
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Abstract
An implantable soft tissue prosthesis device comprising a silicone elastomer-shell filled with silicone gel or liquid, which among the layers that constitute its shell includes a barrier layer formed of a low permeability silicone, which impedes the bleeding or diffusion of the silicone gel from the inside of the implant to its surroundings through the shell. This barrier layer is given a coloration different to the other layers of the shell, making it visible in the finished product. The coloration of the barrier layer gives the fabricator of the implant as well as to medical personnel, the possibility to identify the presence of the barrier layer and its homogeneity, improving the safety of the device.
Claims15
An implantable soft tissue prosthesis device comprising:
- a multilayer shell having one or more layers, the multilayer shell including a silicone elastomer, including:
- the multilayered shell enclosing a lumen filled with at least one of a fluid or a gel;
- wherein at least one layer of the multilayer shell includes a homogenous low diffusion barrier layer, the homogeneous low diffusion barrier layer nestled between at least two layers of the one or more layers;
- and
- wherein the homogenous low diffusion barrier layer includes one or more pigments dispersed in a vinyldimethyl-terminated polydimethylsiloxane polymer.
A multilayered, flexible implant, comprising:
- a shell having one or more layers, surrounding a lumen, including:
- at least one elastomer layer;
- and
- a low diffusion barrier layer nestled between at least two layers of the one or more layers, the low diffusion barrier layer having a color different than the at least one elastomer layer and formed from a material including polydimethylsiloxane and a pendant chemical group including one of a phenyl or fluorine group;
- wherein the low diffusion barrier layer includes a color dispersion including diphenyl group;
- and
- a liquid or gel disposed within the lumen of the shell.
Dependencies are inferred from the claim text.