Implant with a visual indicator of a barrier layer
AssigneeEstablishment Labs S.A.
InventorsRolando MORA, Salvador DADA, Juan Jose CHACON
Life of this patent
Estimating the term…
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.
Claims21
1-5. (canceled)
A prosthesis comprising:
- a flexible shell comprising:
- a plurality of first layers comprising a first silicone material, wherein the plurality of first layers has a first thickness and a first color;
- at least one second layer comprising a second silicone material and a pigment, wherein the at least one second layer has a second thickness smaller than the first thickness and a second color different from the first color, the at least one second layer being a low diffusion layer;
- wherein the second color of the at least one second layer is visually distinguishable through the plurality of first layers without the use of an optical comparator, specialized equipment, or destructive tests.
A prosthesis comprising:
- a flexible shell comprising:
- a plurality of first layers comprising a first silicone material, wherein the plurality of first layers has a first thickness and a first color;
- at least one second layer adjacent to the plurality of first layers, the at least one second layer comprising a second silicone material and a pigment, the at least one second layer having a second thickness smaller than the first thickness;
- and
- a filling material;
- wherein the at least one second layer of the shell impedes passage of the filling material through the shell;
- and
- wherein the pigment is visually distinguishable through the plurality of first layers without the use of an optical comparator, specialized equipment, or destructive tests.
A prosthesis comprising:
- a flexible shell comprising:
- at least one first layer comprising a first silicone material, wherein the at least one first layer has a first thickness and a first color;
- and
- at least one second layer comprising a second silicone material, the at least one second layer having a second thickness different from the first thickness and a second color different from the first color;
- and
- a filling material;
- wherein the at least one second layer forms an innermost layer of the shell;
- the second color being visually distinguishable through the plurality of first layers;
- wherein the at least one second layer impedes diffusion of the filling material through the shell;
- and
- wherein the prosthesis is a breast implant.
Dependencies are inferred from the claim text.