LIGHTWEIGHT BREAST PROSTHESIS

Abstract

The present invention is directed toward a lightweight, external breast prosthesis. In particular, the present invention provides a breast prosthesis comprised of three material layers which allow the production of an extremely light prosthesis while maintaining the look, shape, feel, and behavior of a natural human breast. The outermost layer is comprised of reduced density gel formed in the shape of a human breast. The second layer is a thin layer of standard density gel comprised to provide support and firmness to the outer layer. The innermost layer is a removable foam insert with a sticky coating enabling the innermost layer to “grab” the second layer allowing the three layers of the prosthesis to move as a single unit while maintaining the look, feel, and behavior of a natural human breast at a fraction of the weight of a standard silicone breast prosthesis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

Applicant's invention may be further understood from a description of the accompanying drawings, wherein unless otherwise specified, like referenced numerals are intended to depict like components in the various views.

FIG. 1 is a cross-sectional view of the present invention fully assembled.

FIG. 2 is a cross-sectional view of the outer sections of the present invention.

FIG. 3 is a cross-sectional view of the innermost section of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Referring to FIG. 1, a lightweight, external breast prosthesis is shown and is generally designated by numeral 10. In the preferred embodiment, the primary components incorporated by the present invention are outer section (12), inner section (14), and innermost section (16). As best seen in FIG. 2, outer section (12) is comprised of an outer surface (18) adhered or bonded to middle surface (20) and filled with density reduced gel mixture (22). Correspondingly, inner section (14) is comprised of middle surface (20) adhered or bonded to inner surface (24) and filled with standard gel (26). Finally, as best seen in FIG. 3, innermost section (16) is comprised of coating (28), lightweight form (30), and backing material (32).

In the preferred embodiment, outer surface (18), middle surface (20), and inner surface (24) are composed of thin sheets of a flexible material such as polyurethane. Outer surface (18) is first formed into a desired size of a natural, human breast shape in one of a variety of methods as known in the art. Correspondingly, middle surface (20) and inner surface (24) are adhered or bonded to outer surface (18) using a standard method as known in the art as well. Next, the envelope formed by the engagement of outer surface (18) and middle surface (20) is filled with density reduced gel mixture (22). Finally, the envelope formed by the engagement of middle surface (20) and inner surface (24) is filled with standard gel (26). Then, outer section (12) and inner section (14) are cured as known in the art.

In the preferred embodiment, standard gel (26) is comprised of a standard silicone gel with properties that allow the mimicking of natural breast tissue. Various types of silicone gel are well known for use in breast prostheses, both external and implants, and any of these gels is suitable in the practice of the present invention. However, standard gel (26), in the preferred embodiment of the present invention is comprised of a silicone gel with an approximate density of 0.97 cc.

The composition of density reduced gel mixture (22) is comprised of a standard gel admixed with a density reducing agent, i.e. an agent having a lower density than the standard gel itself for desired weight reduction. The density reducing agent may be comprised of any of a number of density reducing materials, including entrapped air or gas bubbles, expanded perlite, polystyrene beads, glass microspheres, or plastic microspheres. In the preferred embodiment of the present invention, gel mixture (22) is comprised of a standard silicone gel (similar to gel (26)) admixed with glass microspheres. More particularly, in the preferred embodiment of the present invention, density reduced gel mixture (22) has a density of approximately 70 to 80% of that of standard gel (26).

Referring back to FIG. 3, innermost section (16) is comprised of coating (28), lightweight form (30), and backing material (32). Lightweight form (30) is comprised of a lightweight material with extremely high forming properties and a correspondingly extremely low density. In the preferred embodiment, lightweight form (30) is comprised of a lightweight foam material. In the manufacturing process, the foam material is mixed and poured into a mold where backing material (32) is applied. Backing material (32) can be one of various, cloth-type materials as known in the art; however, in the preferred embodiment, backing material (32) is comprised of a cotton fabric for maximum comfort and breathability. After the foam molds, coating (28) is applied to the surface of the foam, and innermost section (16) is heated and cured to give the surface of innermost section (16) a sticky or tacky feel, which allows innermost section (16) to grab inner section (14) when inserted, and it allows prosthesis (10) to move and function as one unit. In the preferred embodiment, coating (28) is a silicone elastomer based material; however, other substances are contemplated, which may be substituted. The necessary property of coating (28) being the sticky or tacky feel upon finalization of innermost section (16).

In summary, it is imperative to the understanding of the present invention that prosthesis (10) be formulated such that outer section (12) be the largest section by percentage of weight; however, the proportions of sections (12,14,16) may be otherwise varied and manipulated to achieve the desired balance between the weight characteristic and the look, feel and behavior of prosthesis (10) itself. Correspondingly, in the preferred embodiment of the present invention, Applicant has found that the most desired balance can be achieved by proportioning the sections in the following manner: outer section (12) comprises 71 to 80% of the weight of prosthesis (10); inner section (14) comprises 11 to 16% of the weight of prosthesis (10); and innermost section (16) comprises 7 to 13% of the weight of prosthesis (10). When prosthesis (10) is produced in the aforementioned range, it has been found that the present invention achieves a 40 to 50% weight reduction from that of a prosthesis solely containing standard silicone gel. Moreover, the preferred range allows the present invention to retain the look, feel, and behavior of a natural breast.

Although the invention has been described with reference to specific embodiments, this description is not meant to be construed in a limited sense. Various modifications of the disclosed embodiments, as well as alternative embodiments of the inventions will become apparent to persons skilled in the art upon reference to the description of the invention. It is, therefore, contemplated that the appended claims will cover such modifications that fall within the scope of the invention.

Claims

1. A breast prosthesis, comprising: a first section, said first section comprising an outer layer of said breast prosthesis;a second section, said second section comprising an inner layer of said breast prosthesis; anda third section, said third section comprising an innermost layer of said breast prosthesis.

2. The breast prosthesis of claim 1 wherein said first section comprises between 71% and 80% of the total weight of said prosthesis, said second section comprises between 11% and 16% of the total weight of said prosthesis, and said third section comprises between 7% and 13% of the total weight of said prosthesis.

3. The breast prosthesis of claim 1 wherein said first section is comprised of a reduced density gel-like substance.

4. The breast prosthesis of claim 3 wherein said second section is comprised of a gel-like substance.

5. The breast prosthesis of claim 4 wherein said third section is comprised of a low density, formable material.

6. The breast prosthesis of claim 5 wherein said reduced density gel-like substance is silicone gel admixed with a density reducing agent.

7. The breast prosthesis of claim 6 wherein said density reducing agent is a plurality of glass microspheres.

8. The breast prosthesis of claim 7 wherein said gel-like substance is silicone gel.

9. The breast prosthesis of claim 8 wherein said low density formable material is foam.

10. The breast prosthesis of claim 9 wherein said first section comprises between 71% and 80% of the total weight of said prosthesis, said second section comprises between 11% and 16% of the total weight of said prosthesis, and said third section comprises between 7% and 13% of the total weight of said prosthesis.

11. A breast prosthesis, comprising: a first section, said first section having a first, outer layer adhered to a first inner layer, wherein said envelope of said first outer layer and said first inner layer contains a reduced density gel, said first section being formed in the shape of a human breast;a second section, said second section being comprised of said first inner layer adhered to a second inner layer, wherein said envelope of said first inner layer and said second inner layer contains a standard density gel, said second section being substantially thinner than said first section; anda third section, said third section being comprised of a low density, formable foam material having a cloth-like backing on a first side and a coating on a second side, said second side being configured for mating with said second section, said coating providing some adherence between said second and said third section.

12. The breast prosthesis of claim 11 wherein said reduced density gel has a density that is between 70% and 80% of the density of said standard density gel.

13. The breast prosthesis of claim 12 wherein said third section is removable.

14. The breast prosthesis of claim 13 wherein said coating is a silicone elastomer-based material.

15. The breast prosthesis of claim 14 wherein said first section comprises between 71% and 80% of the total weight of said prosthesis, said second section comprises between 11% and 16% of the total weight of said prosthesis, and said third section comprises between 7% and 13% of the total weight of said prosthesis.

16. A breast prosthesis, comprising: a first section, said first section having a first, outer layer adhered to a first inner layer, wherein said envelope of said first outer layer and said first inner layer contains a reduced density gel, said first section being formed in the shape of a human breast, said first section comprising between 71% and 80% of the total weight of said breast prosthesis;a second section, said second section being comprised of said first inner layer adhered to a second inner layer, wherein said envelope of said first inner layer and said second inner layer contains a standard density gel, said second section being substantially thinner than said first section, said second section comprising between 11% and 16% of the total weight of said breast prosthesis; anda third section, said third section being comprised of a low density, formable foam material having a cloth-like backing on a first side and a coating on a second side, said second side being configured for mating with said second section, said coating providing some adherence between said second and said third section, said third section comprising between 7% and 13% of the total weight of said breast prosthesis.