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

Abstract

A two-layer external breast prosthesis comprising a first inner layer comprised of a self-shaping dispersion and a second outer layer comprised of an elastic material, wherein the second outer layer is relatively stiffer than the first inner layer.

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.