External breast prosthesis

• US 20090183822A1
• Filed: 03/25/2009
• Published: 07/23/2009
• Est. Priority Date: 09/08/2005
• Status: Active Grant

• Current Assignee: ALPS South LLC (ALPS South Corporation)
• Original Assignee: Aldo A. Laghi
• Inventors: Laghi, Aldo A.
• Granted Patent: US 8,257,531 B2
• Time in Patent Office: Days
• US Class Current: 156/245
• CPC Class Codes: A61F 2/5046 for designing or making customized prostheses, e.g. using templates, finite-element analysis or CAD-CAM techniques
• 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
• CPC Class Codes: Y10T 428/249953 Composite having voids in a component [e.g., porous, cellular, etc.]

Abstract

An external breast prosthesis includes an elastomeric skin in the form of a human breast surrounding an inner material such as a silicone gel or hydrogel. The inner material may be of a defined shape or may be amorphous and conform to the shape of the elastomeric skin. The elastomeric skin can be formed from a front skin and a rear skin, and the skins can be made of a soft styrenic elastomer having attributes similar to a gel. The elastomeric skin can be substantially soft to the touch and have an elastic memory that tends to maintain the skin in a pliable yet pre-defined shape.

Claims

1. A method of making an external breast prosthesis, comprising:

(a) mixing together a polymer and a plasticizing oil to form a mixture;

(b) heating the mixture;

(c) forming the mixture into a front elastomeric skin, wherein the front elastomeric skin has a shape approximating a form of a human breast;

(d) forming a rear elastomeric skin having a shape adapted to seal with the front elastomeric skin;

(e) sealing the front elastomeric skin with the rear elastomeric skin so as to form a cavity therebetween; and

(f) filling a cavity between the front elastomeric skin and the rear elastomeric skin with a gel.

2. The method of claim 1, wherein the polymer comprises a triblock copolymer comprising styrene and at least one of ethylene, butadiene, butylene, isoprene, or propylene.

3. The method of claim 2, wherein the triblock copolymer is any of polystyrene-b-poly(ethylene/propylene), polystyrene-b-poly(ethylene/propylene)-b-polystyrene, polystyrene-b-poly(ethylene/butylene)-b-polystyrene, or polystyrene-b-poly(ethylene-ethylene/propylene)-b-polystyrene.

4. The method of claim 1, wherein the plasticizing oil is any of a paraffinic oil, naphtenic oil, a mineral oil, or a synthetic oligomer comprising polybutene, polypropene, or polyterpene.

5. The method of claim 1, further comprising mixing at least one additive with the polymer and the plasticizing oil, wherein the at least one additive precipitates from the front elastomeric skin after the step (c) of forming the front elastomeric skin.

6. The method of claim 5, wherein the step (c) of forming the front elastomeric skin further comprises cooling the front elastomeric skin.

7. The method of claim 1, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

8. The method of claim 1, further comprising forming an intermediate barrier, and wherein:

the step (e) of sealing the front elastomeric skin with the rear elastomeric skin further comprises sealing the intermediate barrier between the front skin and said the skin such that the cavity comprises a front cavity between the front skin and the intermediate barrier and a rear cavity between the rear skin and the intermediate barrier; and

the step (f) of filling the cavity further comprises filling the front cavity with the gel and filling the rear cavity with a second material.

9. The method of claim 8, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

10. The method of claim 9, wherein the second material comprises any of a gel, a foam, a liquid, a polymer, or any combination thereof.

11. A method of making an external breast prosthesis, comprising:

(a) mixing together a polymer and a plasticizing oil to form a mixture;

(b) heating the mixture;

(c) forming the mixture into an elastomeric skin surrounding a hollow cavity, said skin having a front portion configured and dimensioned to approximate the shape of a human breast; and

(f) filling the cavity with a gel.

12. The method of claim 11, wherein the step (c) of forming the mixture into the elastomeric skin comprises:

transferring the heated mixture into a mold; and

cooling the mixture to form the elastomeric skin.

13. The method of claim 11, wherein the polymer comprises any of polystyrene-b-poly(ethylene/propylene), polystyrene-b-poly(ethylene/propylene)-b-polystyrene, polystyrene-b-poly(ethylene/butylene)-b-polystyrene, or polystyrene-b-poly(ethylene-ethylene/propylene)-b-polystyrene.

14. The method of claim 11, wherein the gel comprises a silicone gel, a hydrogel, or a combination of a silicone gel and a hydrogel.