Breast prosthesis

• US 5,584,883 A
• Filed: 10/11/1994
• Issued: 12/17/1996
• Est. Priority Date: 11/14/1991
• Status: Expired due to Term

• Current Assignee: Amoena Medizin-Orthopadie-Technik GmbH
• Original Assignee: Amoena Medizin-Orthopadie-Technik GmbH
• Inventors: Wild, Helmut F.
• Primary Examiner(s): Brittingham, Debra S.
• Application Number:
  US08/321,584
• Time in Patent Office: 798 Days
• Field of Search: 623/7, 623/8, 623/11, 623/17
• US Class Current: 623/7
• CPC Class Codes: A61F 2/5044 Designing or manufacturing processes
• CPC Class Codes: A61F 2/52 Mammary prostheses brassieres A41C3/00
• CPC Class Codes: A61F 2002/30112 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2002/30156 triangular
• CPC Class Codes: A61F 2002/5007 having elastic means different from springs, e.g. including an elastomeric insert
• CPC Class Codes: A61F 2002/7806 using adhesive means
• CPC Class Codes: A61F 2002/7881 using hook and loop-type fasteners
• CPC Class Codes: A61F 2230/0004 Rounded shapes, e.g. with rounded corners
• CPC Class Codes: A61F 2230/0023 triangular
• CPC Class Codes: B29C 2043/186 hot-melt or heat activated adhesives
• CPC Class Codes: B29C 43/18 incorporating preformed parts or layers, e.g. compression moulding around inserts or for coating articles B29C43/206 takes precedence
• CPC Class Codes: B29C 43/206 by pressing the material between two preformed layers, e.g. deformable layers
• CPC Class Codes: B29C 65/48 using adhesives , i.e. using supplementary joining material; solvent bonding
• CPC Class Codes: B29C 65/4815 Hot melt adhesives, e.g. thermoplastic adhesives
• CPC Class Codes: B29C 65/485 Multi-component adhesives, i.e. chemically curing as a result of the mixing of said multi-components
• CPC Class Codes: B29K 2083/00 Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2105/24 crosslinked or vulcanised
• CPC Class Codes: B29L 2031/727 Fastening elements bolts B29L2001/002; nuts B29L2001/005; screws B29L2001/007; slide fasteners B29L2005/00; buttons for haberdashery B29L2019/00
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses

Abstract

A breast prosthesis comprises a shell-like body of a two-component cross-linked soft elastic silicone rubber composition, which is welded in synthetic resin films, which cover over its inner and outer surfaces.

In order to secure the breast prosthesis directly to the skin of the user, the prosthesis is so designed that on its rear side, in a marginal zone, it is furnished with a permanently adhesive layer.

Claims

1. A one-piece attachable breast prosthesis including a skin-compatible adhesive, said breast prosthesis comprising a shell-like body of a two component, cross-linked soft elastic silicone rubber composition, which is enclosed within synthetic resin coveting films welded around a peripheral edge of said body, said breast prosthesis further comprising a skin-compatible adhesive layer in a marginal zone of a rear side of said prosthesis, adjacent said peripheral edge, wherein a groove having a pair of opposing walls extending into said rear side is formed in the marginal zone, and the skin-compatible adhesive layer is set within the groove.

2. The breast prosthesis as claimed in claim 1, wherein said groove is positioned in at least two areas within the marginal zone, the areas being separated from each other.

3. The breast prosthesis as claimed in claim 1, wherein the groove has an encircling form.

4. The breast prosthesis as claimed in claim 1, wherein the skin-compatible adhesive layer is protected by a cover film laid thereon.

5. The breast prosthesis as claimed in claim 1, wherein the skin-compatible adhesive layer is a first skin-compatible adhesive layer, and further comprising a release film laid on the first skin-compatible adhesive layer and a second skin-compatible adhesive layer positioned on the release film.

6. The breast prosthesis as claimed in claim 5, characterized in that the second skin-compatible adhesive layer is protected by a release film.

7. The breast prosthesis as claimed in claim 1, wherein the skin-compatible adhesive layer includes a cross-linked, two component silicone rubber composition manufactured to be permanently tacky.

8. The breast prosthesis as claimed in claim 7, wherein the permanently tacky layer is applied to a base film, which is attached to the covering film of the breast prosthesis.

9. The breast prosthesis as claimed in claim 8, wherein the base film is bonded to the breast prosthesis covering film by a hotmelt adhesive.

10. The breast prosthesis as claimed in claim 8, wherein the base film is welded to the breast prosthesis covering film.

11. A breast prosthesis comprising a shell-like body of a two component, cross-linked soft elastic silicone rubber composition, which is enclosed within synthetic resin covering films welded around a peripheral edge of said body, said breast prosthesis including a skin-compatible adhesive layer in a marginal zone of a rear side of said prosthesis, adjacent said peripheral edge, wherein a groove having a pair of opposing walls extending into said rear side is formed in the marginal zone, and the skin-compatible adhesive layer is set within the groove.

12. The breast prosthesis as claimed in claim 11, wherein said groove is positioned in at least two areas within the marginal zone, the areas being separated from each other.

13. The breast prosthesis as claimed in claim 11, wherein the skin-compatible adhesive layer is a first skin-compatible adhesive layer, and further comprising a release film laid on the first skin-compatible adhesive layer and a second skin-compatible adhesive layer positioned on the release film.

14. A breast prosthesis, comprising:

a shell-like body of a two component, cross-linked soft elastic silicone rubber composition, which is enclosed within synthetic resin covering films welded around a peripheral edge of said body;

a in-compatible adhesive layer in a marginal zone of a rear side of said prosthesis, adjacent said peripheral edge, wherein a groove having a pair of opposing walls extending into said rear side is formed in the marginal zone, and the skin-compatible adhesive layer is set the groove;

a base film to which the skin-compatible adhesive layer is applied; and

an attachment member attached to the covering film of the breast prosthesis,

said base film being joined to the attachment member by a releasable bond.

15. The breast prosthesis as claimed in claim 14, wherein the attachment member comprises an attachment film bonded to the covering film of the breast prosthesis by means of a hotmelt adhesive.

16. The breast prosthesis as claimed in claim 14, wherein the releasable bond comprises a hook-and-loop fastening means.