External breast prosthesis

• US 7,766,963 B2
• Filed: 09/08/2005
• Issued: 08/03/2010
• Est. Priority Date: 09/08/2005
• Status: Active Grant

• Current Assignee: Alps Intellectual Property Management, LLC
• Original Assignee: ALPS South LLC (ALPS South Corporation)
• Inventors: Laghi, Aldo A.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/222,288
• Publication Number:
  US 20070055371A1
• Time in Patent Office: 1,790 Days
• Field of Search: 623/7, 623/8, 523/105
• US Class Current: 623/7
• 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. An external breast prosthesis, comprising:

(a) front skin formed entirely from a mixture of an elastomeric polymer, a non-volatile additive and a plasticizing oil, said front skin configured and dimensioned in a shape that approximates a form of a human breast;

(b) a rear skin joined with said front skin and forming a cavity therebetween;

(c) a gel disposed in said cavity; and

(d) wherein said front skin has a cratered outer surface formed from said mixture by mixing together said plasticizing oil, said polymer, that together with said plasticizing oil forms said elastomeric polymer, and a predetermined amount of at least one additive to form said mixture;

the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

increasing the temperature of the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution; and

allowing the mixture to cool to form said elastomeric polymer under conditions whereby the additive precipitates and migrates from the mixture to the surface of the elastomeric polymer, leaving craters on the surface of the elastomeric polymer.

2. The breast prosthesis of claim 1, wherein said elastomeric polymer comprises:

a triblock copolymer comprising styrene and at least one of ethylene, butatiene, butylene, isoprene, or propylene; and

a plasticizing agent.

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

4. The breast prosthesis of claim 2, wherein said plasticizing oil is any of a paraffinic oil, napthenic oil, a mineral oil, or a synthetic oligomer comprising polybutene, polypropene, or polyterpene.

5. The breast prosthesis of claim 1, wherein said gel comprises any of a silicone or water-based gel.

6. The breast prosthesis of claim 5, wherein said gel is amorphous and conforms to the shape of the cavity between said front and rear skins.

7. The breast prosthesis of claim 5, wherein said gel has a defined shape when not confined in the cavity between said front and rear skins.

8. The breast prosthesis of claim 5, wherein said gel comprises microspheres.

9. The breast prosthesis of claim 1, wherein said front skin comprises a solid elastomeric nipple.

10. The breast prosthesis of claim 1, further comprising a fabric bonded with said rear skin or said front skin.

11. The breast prosthesis of claim 1, wherein said front skin is adhered with said rear skin at a perimeter seal.

12. The breast prosthesis of claim 1, wherein said front skin and said rear skin are formed as a contiguous skin.

13. The breast prosthesis of claim 1, wherein said front skin has a color approximating a natural skin tone.

14. The breast prosthesis of claim 1, wherein said front skin is translucent and said gel has a first color approximating a natural skin tone.

15. The breast prosthesis of claim 14, wherein said front skin comprises a solid elastomeric nipple and said gel further comprises a region of gel underneath and substantially adjacent to the nipple, said region of gel having a second color of a darker tone than the first color.

16. The breast prosthesis of claim 15, wherein the second color has a fading of intensity from a center of the nipple towards a periphery of the nipple.

17. The breast prosthesis of claim 1, wherein the form of a human breast is a partial breast form.

18. The breast prosthesis of claim 1, wherein said rear skin comprises a concave rear surface adapted to fit against a breast of a user.

19. The breast prosthesis of claim 18, wherein the user is a mastectomy patient and the breast of the user is a partial breast.

20. The breast prosthesis of claim 18, wherein the breast is a full breast and said front skin is dimensioned to provide an external breast enhancement.

21. The breast prosthesis of claim 1, said rear skin further comprising a first portion having a first thickness and a second portion having a second thickness, wherein the first thickness is greater than said second thickness.

22. The breast prosthesis of claim 21, wherein said first portion protrudes into said cavity toward said front skin and said second portion is superior to said central region.

23. The breast prosthesis of claim 1, further comprising a fastener adapted to attach said prosthesis against a user.

24. The breast prosthesis of claim 23, wherein said fastener is attached to a surface of the rear skin opposite the cavity.

25. The breast prosthesis of claim 23, wherein the fastener is further adapted to attach to a garment having a feature for receiving the fastener.

26. The breast prosthesis of claim 1, further comprising an inner barrier disposed within said cavity and separating said cavity into a first chamber and a second chamber, wherein said gel comprises a first gel disposed in said first chamber and a second gel disposed in said second chamber.

50. A kit comprising in a container the breast prosthesis of claim 1, 27 or 35.

27. An external breast prosthesis, comprising:

(a) an elastomeric skin formed entirely from a mixture of a triblock copolymer, at least one non-volatile additive and a plasticizing oil to form said elastomeric skin, said skin having a shape approximating a form of a human breast;

(b) a gel surrounded and contained by said skin; and

(c) wherein said skin has a cratered outer surface formed by mixing together said plasticizing oil, said triblock copolymer, that together with said plasticizing oil forms an elastomeric triblock copolymer, and a predetermined amount of said at least one additive to form said mixture;

the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

increasing the temperature of the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution; and

allowing the mixture to cool to form said elastomeric triblock copolymer under conditions whereby the additive precipitates and migrates from the mixture to the surface of the elastomeric triblock copolymer, leaving craters on the surface of the elastomeric triblock copolymer.

28. The breast prosthesis of claim 27, wherein said triblock copolymer comprises any of a hydrogenated poly(styrene-b-isoprene), a hydrogenated poly(styrene-b-isoprene-b-styrene), a hydrogenated poly(styrene-b-butadiene-b-styrene), or a hydrogenated poly(styrene-b-isoprene/butadiene-b-styrene).

29. The breast prosthesis of claim 27, wherein said gel comprises a silicone gel or a hydrogel.

30. The breast prosthesis of claim 29, wherein said gel substantially conforms to the shape of said skin.

31. The breast prosthesis of claim 27, wherein said elastomeric skin further comprises a front portion and a rear portion, said front portion having the shape approximating a form of a human breast, and said rear portion adapted to conform to a user.

32. The breast prosthesis of claim 31, wherein said rear portion is adapted to conform to a breast of a user to provide an external breast enhancement.

33. The breast prosthesis of claim 31, further comprising a fabric bonded with said skin.

34. A breast prosthesis of claim 33, wherein said fabric is bonded with said rear portion of said skin.

35. An external breast prosthesis, comprising:

(a) a front skin configured and dimensioned in a shape that approximates a form of a human breast and comprising a molded nipple;

(b) a rear skin sealed with said front skin and forming a cavity therebetween;

(c) a fabric bonded with an outer surface of said rear skin;

(d) an inner material disposed in said cavity between said front and rear skins, said inner material comprising a hydrogel and microspheres, wherein said front and rear skins are formed entirely of a mixture of a copolymer of polystyrene-b-poly(ethylene-ethylene/propylene)-b-polystyrene, at least one non-volatile additive, and a plasticizing oil; and

(e) wherein at least said front skin has a cratered outer surface formed by mixing said plasticizing oil and said polystyrene-b-poly(ethylene-ethylene/propylene)-b-polystyrene, that together with said plasticizing oil forms an elastomeric copolymer, and a predetermined amount of said at least one additive to form said mixture;

the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

increasing the temperature of the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution; and

allowing the mixture to cool to form said elastomeric copolymer under conditions whereby the additive precipitates and migrates from the mixture to the surface of the elastomeric copolymer, leaving craters on the surface of the elastomeric copolymer.

36. The breast prosthesis of claim 35, wherein the hydrogel comprises water and a super absorbent polymer, the additive comprises pentaerythritol tetrakis(3-3,5-di-tert-butyl-4-hydroxyphenyl)propionate)), and the plasticizing oil comprises mineral oil.

37. A method of making an external breast prosthesis with a cratered outer surface, comprising:

(a) mixing together a polymer, at least one non-volatile additive and a plasticizing oil to form an elastomeric polymer;

(b) mixing said elastomeric polymer with a predetermined amount of said at least one additive to form a mixture, wherein the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

(c) heating the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution;

(d) forming the mixture into a front elastomeric skin having a front surface and a rear surface, wherein the front elastomeric skin has a shape approximating a form of a human breast;

(e) allowing the mixture to cool to form said front elastomeric skin under conditions whereby the additive precipitates and migrates from the mixture to the front surface of the front elastomeric skin, leaving craters on the front surface of the front elastomeric skin;

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

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

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

38. The method of claim 37, wherein the polymer comprises a triblock copolymer comprising styrene and at least one of ethylene, butadiene, butylene, isoprene, or propylene.

39. The method of claim 38, 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.

40. The method of claim 37, wherein the plasticizing oil is any of a paraffinic oil, napthenic oil, a mineral oil, or a synthetic oligomer comprising polybutene, polypropene, or polyterpene.

41. The method of claim 37, wherein the at least one additive precipitates from the front elastomeric skin after the step (d) of forming the front elastomeric skin.

42. The method of claim 37, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

43. The method of claim 37, further comprising forming an intermediate barrier, and wherein:

the step (g) of sealing the front elastomeric skin with the rear elastomeric skin further comprises sealing the intermediate barrier between the front skin and said rear 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 (h) of filling the cavity further comprises filling the front cavity with a gel and filling the rear cavity with a second material.

44. The method of claim 43, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

45. The method of claim 44, wherein the second material comprises any of a gel, a foam, a liquid, a polymer, or any combination thereof.

46. A method of making an external breast prosthesis with a cratered outer surface, comprising:

(a) mixing together a polymer, at least one non-volatile additive and a plasticizing oil to form an elastomeric polymer;

(b) mixing said elastomeric polymer with a predetermined amount of said at least one additive to form a mixture, wherein the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

(c) heating the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution;

(d) 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;

(e) allowing the mixture to cool to form said elastomeric skin under conditions whereby the additive precipitates and migrates from the mixture to the outer surface of the elastomeric skin, leaving craters on the outer surface of the elastomeric skin; and

(f) filling the cavity with a gel.

47. The method of claim 46, wherein the step (d) 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.

48. The method of claim 46, 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.

49. The method of claim 46, wherein the gel comprises a silicone gel, a hydrogel, or a combination of a silicone gel and a hydrogel.

51. An external breast enhancement, comprising:

an elastomeric skin formed entirely of a mixture of a triblock copolymer, at least one non-volatile additive and a plasticizing oil;

a gel surrounded and contained by said skin, wherein said skin further comprises a rear surface dimensioned to accommodate a breast of a user and a front surface approximating a form of a human breast and dimensioned to enhance a shape of the breast of the user;

wherein at least said front surface comprises a cratered surface formed by (a) mixing together said copolymer and said plasticizing oil to form said elastomeric copolymer;

(b) mixing said elastomeric copolymer with a predetermined amount of said at least one additive to form said mixture, wherein the predetermined amount of additive being in excess of an amount of additive that is soluble in the mixture at room temperature;

(c) heating the mixture to at least a melting point where the mixture becomes molten and the additive is soluble in the molten mixture in a stable solution;

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

(e) allowing the mixture to cool to form said elastomeric skin under conditions whereby the additive precipitates and migrates from the mixture to the front surface of the elastomeric skin, leaving craters on the front surface of the elastomeric skin.

52. The external breast enhancement of claim 51, 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.