Implant with a visual indicator of a barrier layer

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.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This application is the non-provisional of the provisional application Ser. No. 61449931, filed through the EFS with ID 9601953, on Mar. 7, 2011.BACKGROUND OF THE INVENTION[0002]This invention relates to an implantable prosthesis, comprising a multilayer molded elastomer shell, from which one or more of the layers are made of an elastomer with different chemical or physical properties, and which is afterwards filled with a liquid or a gel. Particularly, this invention relates to a prosthesis in which the differentiated layers are made visible by means of fabricating them with a different color material, so the differentiated layers can be easily identified in the final product by mere observation, providing a greater degree of safety of the device.[0003]Today, the augmentation and reconstruction of the human breast requiring the use of an implant, as well as the use of soft tissue implants in other parts of the human body, have become a f...

AI Technical Summary

Benefits of technology

[0009]The present invention provides an implantable device consisting of a flexible elastomer shell enclosing an internal lumen, which is filled with a liquid or gel. The shell includes multiple layers of an elastomer of which the innermost layer comes in direct contact with the filler. One or more of the layers included in the shell structure are made with a different material that will substantially impede the diffusion or bleeding of the filling material particles through the implant shell. These layers are given an identifiable coloration in order to differentiate them from the other layers. The coloration of the barrier layers allows a series of advantages over traditional implants, including the possibility of visually identifying the existence of the barrier layer in each implant, as well as the correct and homogenous application of the same. This also allows the possibility of including the control of the barrier layer as a simpler part of the quality control process in the fabrication of the implants, and allows the medical professionals who have the responsibility of employing such implants in surgical procedures to verify the presence and correctness of the barrier layer by simple observation.

Problems solved by technology

Even though the performance of such barrier layers is considered acceptable at their present state of development, a serious problem persists in the use of this devices, both at the manufacturing and operating room levels, which is the impossibility for quality control personnel and medical staff of easily identifying the presence of the important low diffusion barrier layers within the complete prosthesis, without the use of impractical specialized equipment or without the use of destructive tests.

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