External breast prosthesis

• US 20070055371A1
• Filed: 09/08/2005
• Published: 03/08/2007
• Est. Priority Date: 09/08/2005
• Status: Active Grant

• Current Assignee: Alps Intellectual Property Management, LLC
• Original Assignee: Alps Intellectual Property Management, LLC
• Inventors: Laghi, Aldo
• Granted Patent: US 7,766,963 B2
• Time in Patent Office: Days
• 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. A breast prosthesis, comprising:

(a) a front skin comprising an elastomeric polymer, 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; and

(c) a gel disposed in said cavity.

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

a triblock copolymer comprising styrene and at least one of ethylene, butadiene, 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-poly(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 agent is any of a paraffinic oil, naphtenic oil, a mineral oil, or a synthetic oligomer comprising polybutene, polypropene, or polyterpene.

5. The breast prosthesis of claim 2, wherein said elastomeric polymer further comprises an additive that precipitates from the elastomeric polymer during formation of the elastomeric polymer.

6. The breast prosthesis of claim 5, wherein said elastomeric polymer comprises the additive in an amount that is in excess of an amount of the additive that is soluble in the elastomer at room temperature.

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

8. The breast prosthesis of claim 7, wherein said gel is amorphous and conforms to the shape of the cavity between said front and rear skins.

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

10. The breast prosthesis of claim 7, wherein said gel comprises microspheres.

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

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

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

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

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

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

17. The breast prosthesis of claim 16, wherein said front skin comprises a solid elastomeric nipple and said inner material further comprises a region of inner material underneath and substantially adjacent to the nipple, said region of inner material having a second color of a darker tone than the first color.

18. The breast prosthesis of claim 17 wherein the second color has a fading of intensity from a center of the nipple towards a periphery of the nipple.

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

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

21. The breast prosthesis of claim 20, wherein the user is a mastectomy patient and the breast of the user is a partial breast.

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

23. 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 said first thickness is greater than said second thickness.

24. The breast prosthesis of claim 23, wherein said first portion protrudes into said cavity toward said front skin and said second portion is superior to said central region.

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

26. The breast prosthesis of claim 25, wherein said fastener is attached to a surface of the rear skin opposite the cavity.

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

28. 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.

58. A kit comprising in a container the breast prosthesis of claim 1, 29 or 37.

29. A breast prosthesis, comprising:

(a) an elastomeric skin comprising a triblock copolymer, said skin having a shape that approximating a form of a human breast; and

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

30. The breast prosthesis of claim 29, 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).

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

32. The breast prosthesis of claim 31, wherein said gel substantially conforms to the shape of said skin.

33. The breast prosthesis of claim 29, 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.

34. The breast prosthesis of claim 33, wherein said rear portion is adapted to conform to a breast of a user to provide an external breast enhancement.

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

36. The breast prosthesis of claim 35, wherein said fabric is bonded with said rear portion of said skin.

37. A 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; and

(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 comprise a polystyrene-b-poly(ethylene-ethylene/propylene)-b-polystyrene, an additive, and a plasticizing oil.

38. The breast prosthesis of claim 37, 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.

39. 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.

40. The method of claim 39, wherein the polymer comprises a triblock copolymer comprising styrene and at least one of ethylene, butadiene, butylene, isoprene, or propylene.

41. The method of claim 40, 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.

42. The method of claim 39, wherein the plasticizing oil is any of a paraffinic oil, naphtenic oil, a mineral oil, or a synthetic oligomer comprising polybutene, polypropene, or polyterpene.

43. The method of claim 39, 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.

44. The method of claim 43, wherein the step (c) of forming the front elastomeric skin further comprises cooling the front elastomeric skin.

45. The method of claim 39, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

46. The method of claim 39, 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.

47. The method of claim 46, wherein the gel comprises any of a silicone gel, a hydrogel, or a combination thereof.

48. The method of claim 47, wherein the second material comprises any of a gel, a foam, a liquid, a polymer, or any combination thereof.

49. 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.

50. The method of claim 49, 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.

51. The method of claim 49, 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.

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

53. A kit, comprising in one or more containers:

an external breast prosthesis comprising a front skin configured and dimensioned in a shape that approximates a form of a human breast, a rear skin joined with said front skin and forming a cavity therebetween; and

a gel disposed in said cavity, wherein said front skin comprises an elastomeric polymer; and

a garment having a pocket adapted to hold said external breast prosthesis against a user when the garment is worn by a user.

54. The kit of claim 53, wherein said garment further comprises a breast cup for supporting a breast of a user when the garment is worn by a user.

55. The kit of claim 53, wherein the garment is a mastectomy bra.

56. The kit of claim 53, wherein said elastomeric polymer comprises:

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

a plasticizing agent.

57. The kit of claim 56, 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.

59. An external breast enhancement, comprising:

an elastomeric skin comprising a triblock copolymer; and

a gel surrounded and contained by said skin,

wherein said skin further comprises a concave 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.

60. The external breast enhancement of claim 59, wherein said elastomeric skin further comprises a plasticizing oil, and wherein said 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.

61. A garment, comprising:

an external breast prosthesis comprising a gel bounded by an elastomeric skin comprising a triblock co-polymer, said elastomeric skin having a shape approximating a human breast;

at least one support attached with said external breast prosthesis and configured to position said external breast prosthesis against a user such that the shape of said external breast prosthesis provides an appearance of a normal breast of the user.