Method of making an external breast prosthesis

• US 8,257,531 B2
• Filed: 03/25/2009
• Issued: 09/04/2012
• Est. Priority Date: 09/08/2005
• Status: Active Grant

• Current Assignee: ALPS South LLC (ALPS South Corporation)
• Original Assignee: ALPS South LLC (ALPS South Corporation)
• Inventors: Laghi, Aldo A.
• Primary Examiner(s): Lee, Katarzyna Wyrozebski
• Assistant Examiner(s): Patel, Vishal I
• Application Number:
  US12/383,490
• Publication Number:
  US 20090183822A1
• Time in Patent Office: 1,259 Days
• Field of Search: 156/145, 428/304.4
• US Class Current: 156/145
• 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

A method of making an external breast prosthesis by forming an elastomeric skin in the form of a human breast surrounding an inner material such as a silicone gel or hydrogel. 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. At least the front skin is formed by mixing together a polymer, a plasticizing oil and at least one non-volatile additive to form a mixture, heating the mixture, forming the mixture into a front elastomeric skin, and cooling the mixture thereby allowing the non-volatile additive to precipitate to the outer surface of the outer skin to form a cratered outer surface that is substantially soft to the touch and 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 and at least one non-volatile additive 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) cooling the mixture thereby allowing the non-volatile additive to precipitate to the outer surface of the outer skin whereby a cratered outer surface is formed;

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

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

(g) 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, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

6. 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.

7. The method of claim 6, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

8. The method of claim 7, wherein the second material comprises any of a gel, a foam, a liquid, a polymer, or any combination thereof.

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

(a) mixing together a polymer and a plasticizing oil and at least one non-volatile additive 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;

(d) cooling the mixture thereby allowing the non-volatile additive to precipitate to the outer surface of the elastomeric skin whereby a cratered outer surface is formed; and

(e) filling the cavity with a gel.

10. The method of claim 9, 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.

11. The method of claim 9, 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.

12. The method of claim 9, wherein the gel comprises a silicone gel, a hydrogel, or a combination of a silicone gel and a hydrogel.