Attachable two-chamber breast prosthesis

• US 5,895,423 A
• Filed: 02/21/1997
• Issued: 04/20/1999
• Est. Priority Date: 02/23/1996
• Status: Expired due to Fees

• Current Assignee: Amoena Medizin-Orthopadie-Technik GmbH
• Original Assignee: Coloplast Corporation (Coloplast A/S)
• Inventors: Becker, Anne Roesler, DiMarco, Michael Anthony, Hodgkins, Diane Taryn-Leigh, Malice, Louis F. Jr.
• Primary Examiner(s): Cain, Edward J.
• Application Number:
  US08/803,201
• Time in Patent Office: 788 Days
• Field of Search: 623/7, 623/8, 623/12, 623/901
• US Class Current: 623/7
• CPC Class Codes: A61F 2/5044 Designing or manufacturing processes
• CPC Class Codes: A61F 2/52 Mammary prostheses brassieres A41C3/00
• CPC Class Codes: A61F 2002/30016 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: A61F 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/30176 V-shaped
• CPC Class Codes: A61F 2002/5012 having two or more inflatable pockets
• CPC Class Codes: A61F 2002/7881 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0019 differing in hardness, e.g. Vickers, Shore, Brinell
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

An attachable two-chamber breast prosthesis includes two volumes of silicone materials that have different degrees of softness. The prosthesis includes three pieces of polyurethane film (a front film, a middle film, and a rear film) that form a front chamber and rear chamber. The periphery of the front chamber is smaller than the periphery of the rear chamber. The rear chamber, which contains the firmer silicone material, extends to the peripheral edge of the prosthesis. The front chamber, which contains the softer silicone material, does not extend all the way to the peripheral edge along the upper region of the prosthesis. By increasing the thickness of the rear chamber along a boomerang-shaped region defined by the peripheries of the front and rear chambers, the firmer silicone material in the rear chamber provides the prosthesis with proper support and reduces the tendency of the prosthesis to pull away from the skin along the top edge of the prosthesis.

Claims

1. A breast prosthesis, comprising:

a front portion enclosed between a first film and a second film and having a first periphery; and

a rear portion enclosed between the second film and a third film and having a second periphery;

wherein the first periphery is smaller than the second periphery.

2. The breast prosthesis of claim 1, wherein the front portion comprises a first gel-like material and the second portion comprises a second gel-like material.

3. The breast prosthesis of claim 2, wherein the first and second gel-like materials comprise two-component cross-linked silicone materials.

4. The breast prosthesis of claim 2, wherein the first gel-like material is softer than the second gel-like material.

5. The breast prosthesis of claim 1, wherein the second and third films are bonded at a location within the second periphery.

6. The breast prosthesis of claim 1, further comprising a plurality of attachment members affixed to an exterior surface of the rear portion.

7. The breast prosthesis of claim 6, wherein one of the attachment members is a top attachment member, and wherein a top portion of the first periphery does not extend above the attachment member.

8. The breast prosthesis of claim 1, wherein a region extending from the first periphery to the second periphery has a curved shape.

9. The breast prosthesis of claim 1, wherein the first film, second film, and third film comprise polyurethane.

23. An attachable breast prosthesis assembly comprising:

the breast prosthesis of claim 1; and

a skin support.

24. The attachable breast prosthesis assembly of claim 23, wherein the skin support further comprises an adhesive on an exterior surface of the skin support.

25. The attachable breast prosthesis assembly of claim 23, wherein the skin support further comprises attachment means on an exterior surface of the skin support.

10. An attachable two-chamber breast prosthesis, comprising:

a front chamber formed by a first film and a second film, the front chamber being filled with a first gel-like material;

a rear chamber formed by the second film and a third film, the rear chamber being filled with a second gel-like material;

an upper region formed by joining the first film and the second film along a two dimensional area; and

attachment members affixed to the exterior of the rear chamber,

whereby the first and second films form a first periphery of the front chamber which is smaller than a second periphery of the rear chamber.

11. The attachable two-chamber breast prosthesis of claim 10, wherein the first gel-like material is softer than the second gel-like material.

12. The attachable two-chamber breast prosthesis of claim 10, wherein the first and second gel-like materials comprise two-component cross-linked silicone materials.

13. The attachable two-chamber breast prosthesis of claim 10, wherein the first, second, and third films comprise polyurethane.

14. The attachable two-chamber breast prosthesis of claim 10, wherein the second and third films are bonded at a location within the second periphery.

15. The attachable two-chamber breast prosthesis of claim 10, wherein one of the attachment members is a top attachment member, and wherein a top portion of the first periphery does not extend above the top attachment member.

16. A method for manufacturing a breast, comprising the steps of:

joining a two-dimensional area of a first film and a second film to form an upper region of the prosthesis;

joining the first film, the second film, and a third film along a peripheral edge to form a first chamber between the first film and a second film and a second chamber between the second film and the third film, the first chamber having a periphery that is smaller than a periphery of the second chamber;

placing the first, second, and third plastic films in a mold, the mold defining a shape of the prosthesis;

introducing a first gel-like material into the first chamber;

introducing a second gel-like material into the second chamber; and

curing the first and second gel-like materials.

17. The method of claim 16, wherein the joined portions of the first and second films have a generally curved shape.

18. The method of claim 16, wherein the upper region of the prosthesis has a boomerang shape.

19. The method of claim 16, future comprising the step of bonding the second film and the third film at a location within the second periphery.

20. The method of claim 16, further comprising the step of affixing attachment members to the third film during curing.

21. The method of claim 16, wherein the first film, second film, and third film comprise polyurethane.

22. The method of claim 16, wherein the first and second gel-like materials comprise a two-component cross-linking silicone material.