Extreme volume flexible integrity prosthesis

• US 6,520,989 B1
• Filed: 01/18/2000
• Issued: 02/18/2003
• Est. Priority Date: 01/18/2000
• Status: Expired due to Term

• Current Assignee: Bioventures, LLC
• Original Assignee: The Board of Trustees of the University of Arkansas (University of Arkansas System)
• Inventors: Eaton, L. Daniel
• Primary Examiner(s): Snow, Bruce
• Assistant Examiner(s): Pellegrino, Brian E.
• Application Number:
  US09/484,155
• Time in Patent Office: 1,127 Days
• Field of Search: 623/8, 623/7, 623/4.1
• US Class Current: 623/7
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2/52 Mammary prostheses brassieres A41C3/00
• CPC Class Codes: A61F 2002/5053 using a positive or a negative model, e.g. casting model or mould

Abstract

A flexible external prosthesis formed by first creating a thin walled hollow elastomeric shell of the shape required for anatomical augmentation. The interior of the hollow shell is filled with a flexible foam body formed into the same shape. The foam is formed by either of two methods. In one method the same mold used to form the thin walled hollow shell is used again to shape the foam into the same shape as the hollow shell. The hollow prosthesis may then be opened, the foam body inserted and the shell resealed. In another method, the foam is injected into the hollow shell while it is contained in the mold. The foam is desirably a two-part material which chemically generates a foaming agent when the two parts are mixed together. The foam then expands into the interior of the hollow shell and assumes the shape imposed by the mold. The foam body is lubricated to ensure free movement of the shell with respect to the foam body, desirably using a triglyceride oil, such as soy bean oil. By using the foam body to support the hollow prosthesis shell, it is possible to make the thickness of the shell walls thinner and thus more natural in feel and appearance. The foam body is colored with an opaque pigment and the shell is colored with a translucent pigment.

Claims

1. An external prosthesis for augmenting deficient anatomy, comprising:

a fluid tight elastomeric shell formed in a desired shape to augment the deficient anatomy;

said elastomeric shell having walls with a thickness less than about 2.0 millimeters;

an elastomeric foam body formed into a shape allowing said foam body to fill said elastomeric shell and to support said walls of said elastomeric shell; and

lubricating oil disposed within said shell for low friction movement of said walls of said elastomeric shell with respect to said foam body;

wherein said elastomeric foam body further comprises opaque coloring means and said elastomeric shell further comprises translucent coloring means; and

wherein said lubricating oil further comprises means for coloring said lubricating oil.

2. The external prosthesis of claim 1 wherein said foam body further comprises a posterior surface and means attaching said posterior surface of said foam body to said posterior wall of said elastomeric shell.

3. The external prosthesis of claim 1, wherein said anterior wall of said elastomeric shell has an interior surface having open-ended hollow tubes affixed to said interior surface.

4. An external prosthesis for augmenting deficient anatomy, comprising:

a fluid tight elastomeric shell formed in a desired shape to augment the deficient anatomy;

said elastomeric shell having walls with a thickness less than about 2.0 millimeters;

an elastomeric foam body formed into a shape allowing said foam body to fill said elastomeric shell and to support said walls of said elastomeric shell; and

lubricating oil disposed within said shell for low friction movement of said walls of said elastomeric shell with respect to said foam body;

wherein said elastomeric foam body further comprises opaque coloring means and said elastomeric shell further comprises translucent coloring means;

wherein said elastomeric shell comprises a posterior wall and an anterior wall replicating the appearance of a natural breast; and

wherein said lubricating oil further comprises means for coloring said lubricating oil.

5. The external prosthesis of claim 4 wherein said elastomeric shell further comprises lateral periphera and said lateral periphera further comprises a plurality of vent slots for venting the anterior of said elastomeric shell.

6. An external prosthesis for augmenting deficient anatomy, comprising:

a fluid tight elastomeric shell formed in a desired shape to augment the deficient anatomy;

said elastomeric shell having walls with a thickness less than about 2.0 millimeters;

an elastomeric foam body formed into a shape allowing said foam body to fill said elastomeric shell and to support said walls of said elastomeric shell; and

lubricating oil disposed within said shell for low friction movement of said walls of said elastomeric shell with respect to said foam body;

wherein said elastomeric foam body further comprises opaque coloring means and said elastomeric shell further comprises translucent coloring means;

wherein said elastomeric shell comprises a posterior wall and an anterior wall replicating the appearance of a natural breast;

wherein said elastomeric foam body comprises a superior portion and an inferior portion and further wherein said inferior portion further comprises accordioning means for allowing said inferior portion to be more easily compressed than said superior portion; and

wherein said accordioning means comprises one or more wedge-shaped cutouts in said inferior portion.

7. The external prosthesis of claim 6 wherein said lubricating oil comprises a triglyceride oil.

8. The external prosthesis of claim 7 wherein said triglyceride oil is soy bean oil.

9. The external prosthesis of claim 6 wherein said lubricating oil further comprises means for coloring said lubricating oil.