Two-layer external breast prosthesis with self-shaping feature and process for the manufacture thereof

1 . A two-layer external breast prosthesis, comprising:

a) a first inner layer comprised of a self-shaping dispersion, said dispersion having a specific gravity of less than 1.0; and

b) a second outer layer comprised of an elastic material, wherein said second outer layer is stiffer than said first inner layer.

2 . The prosthesis of claim 1 , wherein the elastic material of said second outer layer comprises a silicon gel.

3 . The prosthesis of claim 1 , wherein the elastic material of said second outer layer is heat cured.

4 . The prosthesis of claim 1 , wherein the self-shaping dispersion of said first inner layer is uncured and comprised of a silicone oil and a plurality of microspheres.

5 . The prosthesis of claim 4 , wherein the silicone oil has a viscosity of approximately 500 CSt.

6 . The prosthesis of claim 4 , wherein the plurality of microspheres are comprised of an acrylonitrile copolymer and have an average particle size of from approximately 40 microns to approximately 125 microns.

7 . The prosthesis of claim 1 , further comprising a film wall separating said inner layer and said outer layer.

8 . The prosthesis of claim 1 , wherein said inner layer is confined within a first film envelope, and wherein said outer layer is confined within a second film envelope.

9 . The prosthesis of claim 8 , wherein the said first and second film envelopes share a common film wall therebetween.

10 . The prosthesis of claim 8 , wherein said first and said second film envelopes each comprise a polyurethane film.

11 . The prosthesis of claim 1 , wherein said inner layer is confined within a first film envelope and is sufficiently soft to yield to the touch, and wherein said outer layer is sufficiently stiff to substantially prevent wrinkling of a second film envelope confining said outer layer.

12 . The prosthesis of claim 1 , wherein said outer layer is sufficiently stiff to generally retain the shape of a human breast.

13 . A two-layer breast prosthesis, comprising:

a) a first film envelope configured to define a first interior volume;

b) a second film envelope joined to the first film envelope along a common side edge to thereby define a second interior volume wherein said second film envelope and first film envelope share a common film wall;

c) a first and a second sealed fill opening, respectively, extending from the common side edge of the first film envelope and the second film envelope to the respective first and second interior volumes;

d) a first material within said first film envelope forming an interior body portion of the prosthesis, said first material comprising a self-shaping material; and

e) a second material within said second film envelope forming an exterior body portion of the prosthesis, said second material comprising an elastic material.

14 . The prosthesis of claim 13 , wherein the self-shaping material of d) is a self-shaping dispersion comprised of a silicone oil and a plurality of microspheres.

15 . The prosthesis of claim 13 , wherein said self-shaping material of d) is constructed and arranged to be yieldably shaped by a patient's chest wall.

16 . The prosthesis of claim 14 , wherein the respective plurality of microspheres have an average particle size of from 40 microns to 125 microns.

17 . The prosthesis of claim 14 , wherein said microspheres are comprised of an acrylonitrile copolymer.

18 . The prosthesis of claim 14 , wherein said microspheres are filled with isobutane.

19 . The prosthesis of claim 13 , wherein the first material of d) has a specific gravity less than approximately 1.