Synthetic reconstructive implant device

• US 5,344,451 A
• Filed: 05/05/1993
• Issued: 09/06/1994
• Est. Priority Date: 06/24/1992
• Status: Expired due to Term

• Current Assignee: Michael P. Dayton
• Original Assignee: Michael P. Dayton
• Inventors: Dayton, Michael P.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/059,178
• Time in Patent Office: 489 Days
• Field of Search: 623/7, 623/8, 623/11, 623/17, 623/1
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• CPC Class Codes: A61L 27/20 Polysaccharides
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: C08L 1/28 Alkyl ethers
• CPC Class Codes: C08L 5/08 Chitin; Chondroitin sulfate; Hyaluronic acid; Derivatives thereof

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.

Claims

1. A synthetic reconstructive surgical breast implant device suitable for implanting as a breast implant in contact with tissue in a human comprising:

a sealed envelope having a surface exposed for direct contact with said tissue, said envelope having a predetermined shape when filled, said enveloped being formed from an elastic polymer having a microporous structure of a selected pore size;

a biocompatible viscoelastic material filling said envelope in an amount sufficient to provide said predetermined shape, said biocompatible viscoelastic material being a sterile, non-pyrogenic solution selected from the group consisting of salt of chondroitin sulfate, salts of hyaluronate, polysaccharide, hydroxypropylmethylcellulose and mixtures of at least two of this group; and

a bioactive substance admixed in said polymer for elution from said microporous structure of said envelope after implantation and contact of said surface with tissue in a human, and having a concentration and molecular weight selected to achieve a desired equilibrium between said envelope surface and said tissue proximate said envelope upon implant to control said elution of said bioactive substance.

2. The device of claim 1, wherein said envelope is selected from the group consisting of silicone, polyurethane, polyvinyl alcohol, polyethylene, polyesters, tetrafluoroethylene and polytetrafluroethylene, hydrogels, fluorosilicone and mixtures of at least two of this group.

3. The device of claim 1, wherein said bioactive substance is selected from the group consisting of heparin, prostacyclenes, steroids, ibuprofen, antimicrobials, antibiotics, tissue plasma activators, monoclonal antibodies, snake venom protein by products, antifibrosis agents, cyclosporine and mixtures of at least two of this group.