Synthetic reconstructive implant device

Abstract

Abstract A synthetic reconstructive surgical implant device and method for making the same in which the device is suitable for implanting in a human. The device includes a sealed prosthesis envelope having a predetermined shape when filled, with the envelope being formed from an elastic polymer having a microporous structure with a texturized or non-texturized surface, such as silicone, polyurethane, polyvinylalcohol polyethylene, polyesters, hydrogels, tetrafluroethylene and polytetrafluroethylene, fluorosilicone and mixtures thereof. The envelope is filled with a biocompatible viscoelastic material in an amount sufficient to provide the predetermined shape. The biocompatible viscoelastic material is a sterile, non-pyrogenic solution which, in a preferred embodiment may be selected from salts of chondrotin sulfate, salts of hyaluronate, hydroxyproplymethylcellulose and mixtures thereof. In another preferred embodiment, the device includes a bioactive substance admixed in the polymer for elution from the microporous structure of the envelope after implantation. The bioactive substance may be selected from the group of heparin, prostacyclenes, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, monoclonal antibodies, snake venom protein by-products, antifibrosis agents, cyclosporine and mixtures thereof. The rate of elution of the bioactive substance is controlled by selecting a pore size for the microporous structure in response to the concentration and molecular weight of the bioactive substance to achieve equilibrium between the envelope surface and the tissue proximate the envelope upon implant.

Inventors

• 👤 Michael P. Dayton

Bibliographic Details