CA2204490C - Breast prosthesis - Google Patents
Breast prosthesis Download PDFInfo
- Publication number
- CA2204490C CA2204490C CA002204490A CA2204490A CA2204490C CA 2204490 C CA2204490 C CA 2204490C CA 002204490 A CA002204490 A CA 002204490A CA 2204490 A CA2204490 A CA 2204490A CA 2204490 C CA2204490 C CA 2204490C
- Authority
- CA
- Canada
- Prior art keywords
- chamber
- prosthesis
- mammary prosthesis
- plastic
- shell
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/52—Mammary prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/50—Prostheses not implantable in the body
- A61F2/52—Mammary prostheses
- A61F2002/523—Multiple breast forms made of several concentric breast-shaped layers nested into one another
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention relates to a breast prosthesis consisting of a shell-shaped body made from a soft and elastic plastic which is welded into plastic films and so forms a first chamber and of a second chamber filled with a different filling material facing the wearer during wear and connecting to the first chamber. In accordance with the invention, the filling material of the second chamber consists of a thixotropic material.
Description
Breast prosthesis The invention relates to a breast prosthesis consisting of a shell-shaped body made from a soft and elastic plastic, preferably from an addition-vulcanised two-component silicone rubber mass, which body is welded into plastic films and so forms a first chamber and of a second chamber filled with a different filling material facing the wearer during wear and connecting to the first chamber.
Breast prostheses consisting of a shell-shaped body made from a soft and elastic addition-vulcanised two-component silicone rubber welded in plastic films are already known, for example from DE 90 10 426.9.
Such breast prostheses are used for cosmetic reasons after breast amputations due to cancer. In very recent times, new operation methods are becoming popular in which only the cancerous parts of the breast are operated, so that here only a partial amputation is performed. Due to this procedure, scar areas whose irregularities are individually different are created which - just like the remaining residual tissue - form surfaces undefined as such. When conventional breast prostheses are worn, this irregular surface now causes the problem that frequently the soft-elastic plastic applies pressure due to its inherent elasticity to the scar area of the only partially amputated breast and in this way leads to a reduction in the wearing comfort. In the case of a correspondingly large residual tissue area, the breast prosthesis will frequently no longer fit.
_7_ DE 44 21 516 A reveals a two-chamber breast prosthesis of the generic type in which the second chamber is filled with a pad body made from foamed plastic or with a fibre ball.
It is the object of the present invention to provide a breast prosthesis which is also particularly suitable for the provision of care to patients after a partial amputation of the breast.
In accordance with the invention, this object is solved on the basis of a breast prosthesis of the generic type by the filling material of the second chamber consisting of a thixotropic material which adapts to the irregular scar situation of the partially amputated breast when the breast prosthesis is put on and which essentially maintains this shape.
Of particular advantage is a pasty material consisting essentially of a mixture of non-vulcanised silicone oil and silicic acid. In addition, light filling material, preferably plastic microspheres, can be added to the mixture.
One special embodiment of the invention provides for the external wall of the second chamber, which external wall also consists of a plastic film, having a fill-up valve by which the fill material can be filled in. In this way, a corresponding intermediate area can be created individually by a possible partial filling or a correspondingly adapted filling of the second chamber which creates a better adaptation of the breast prosthesis to the operation scar.
The shell-shaped first chamber can protrude over the rim of the second chamber with its rim area so that a hollow is produced. On the other hand, the rim of the second chamber can lie on the rim of the first chamber so that only a slightly concave arching is produced in section.
If required, the breast prosthesis can be designed as a partial prosthesis which corresponds only to the breast portion to be substituted.
The invention therefore seeks to provide a mammary prosthesis comprising a shell-like body of a plastic with flexible elastic properties, having a first chamber comprising welded plastic sheets and a first filler material, and a second chamber connected to the first chamber, facing the wearer while being worn, and filled with a second filler material comprising a thixotropic material.
Further details and advantages of the invention are described in more detail below by means of an embodiment presented in the drawings which show:
Fig. 1: a schematic sectional view of a first embodiment of the breast prosthesis in accordance with the invention, Fig. 2: a section through a second embodiment of a breast prosthesis in accordance with the invention.
Fig. 3: a rear view of the embodiment of Fig. 2 of the completely filled second chamber and Fig. 4: a rear view of Fig. 3, but with a partially filled second chamber.
The breast prosthesis 10 shown in Fig. 1 consists of a shell-shaped body 12 made from a soft and elastic addition-vulcanised two-component silicone rubber mass whose external side is covered by a polyurethane film 14 and whose internal side is covered by a polyurethane film 16 which are welded together along their shared circumferential rim 18 by a continuous welding seam. In this way, a first chamber 20 is produced. Within the hollow produced by the shell-shaped design of the first chamber 20, a second chamber 22 is positioned which is limited by a wall 24 also formed by a polyurethane film. The polyurethane walls, 14, 16 and 24 advantageously possess in the embodiment of Fig. 1 a shared circumferential rim 18 which is designed as a common weld seam. In the second chamber 22 a pasty material is filled in accordance with the invention which consists of a mixture of non-vulcanised silicone oil and silicic acid to which plastic microspheres is added as a light filling material.
The mixture of silicone oil and silicic acid is particularly well suited as a pasty material as a movability and thus an adaptation to the scar area is ensured by the silicone oil while, on the other hand, the silicic acid particles strive for entanglement with each other and thus to form a largely shape-stable unit if no further pressure is exercised on the surface of the second chamber. The plastic microspheres serve to reduce the specific weight of the total mixture and so to make the whole breast prosthesis lighter.
In Fig. 2 a modified form of a breast prosthesis 10 in accordance with the invention is shown in which the rim area of the first chamber protrudes over the rim of the second chamber. Here, a flat hollow is thus formed as is shown in the section in Fig.
Breast prostheses consisting of a shell-shaped body made from a soft and elastic addition-vulcanised two-component silicone rubber welded in plastic films are already known, for example from DE 90 10 426.9.
Such breast prostheses are used for cosmetic reasons after breast amputations due to cancer. In very recent times, new operation methods are becoming popular in which only the cancerous parts of the breast are operated, so that here only a partial amputation is performed. Due to this procedure, scar areas whose irregularities are individually different are created which - just like the remaining residual tissue - form surfaces undefined as such. When conventional breast prostheses are worn, this irregular surface now causes the problem that frequently the soft-elastic plastic applies pressure due to its inherent elasticity to the scar area of the only partially amputated breast and in this way leads to a reduction in the wearing comfort. In the case of a correspondingly large residual tissue area, the breast prosthesis will frequently no longer fit.
_7_ DE 44 21 516 A reveals a two-chamber breast prosthesis of the generic type in which the second chamber is filled with a pad body made from foamed plastic or with a fibre ball.
It is the object of the present invention to provide a breast prosthesis which is also particularly suitable for the provision of care to patients after a partial amputation of the breast.
In accordance with the invention, this object is solved on the basis of a breast prosthesis of the generic type by the filling material of the second chamber consisting of a thixotropic material which adapts to the irregular scar situation of the partially amputated breast when the breast prosthesis is put on and which essentially maintains this shape.
Of particular advantage is a pasty material consisting essentially of a mixture of non-vulcanised silicone oil and silicic acid. In addition, light filling material, preferably plastic microspheres, can be added to the mixture.
One special embodiment of the invention provides for the external wall of the second chamber, which external wall also consists of a plastic film, having a fill-up valve by which the fill material can be filled in. In this way, a corresponding intermediate area can be created individually by a possible partial filling or a correspondingly adapted filling of the second chamber which creates a better adaptation of the breast prosthesis to the operation scar.
The shell-shaped first chamber can protrude over the rim of the second chamber with its rim area so that a hollow is produced. On the other hand, the rim of the second chamber can lie on the rim of the first chamber so that only a slightly concave arching is produced in section.
If required, the breast prosthesis can be designed as a partial prosthesis which corresponds only to the breast portion to be substituted.
The invention therefore seeks to provide a mammary prosthesis comprising a shell-like body of a plastic with flexible elastic properties, having a first chamber comprising welded plastic sheets and a first filler material, and a second chamber connected to the first chamber, facing the wearer while being worn, and filled with a second filler material comprising a thixotropic material.
Further details and advantages of the invention are described in more detail below by means of an embodiment presented in the drawings which show:
Fig. 1: a schematic sectional view of a first embodiment of the breast prosthesis in accordance with the invention, Fig. 2: a section through a second embodiment of a breast prosthesis in accordance with the invention.
Fig. 3: a rear view of the embodiment of Fig. 2 of the completely filled second chamber and Fig. 4: a rear view of Fig. 3, but with a partially filled second chamber.
The breast prosthesis 10 shown in Fig. 1 consists of a shell-shaped body 12 made from a soft and elastic addition-vulcanised two-component silicone rubber mass whose external side is covered by a polyurethane film 14 and whose internal side is covered by a polyurethane film 16 which are welded together along their shared circumferential rim 18 by a continuous welding seam. In this way, a first chamber 20 is produced. Within the hollow produced by the shell-shaped design of the first chamber 20, a second chamber 22 is positioned which is limited by a wall 24 also formed by a polyurethane film. The polyurethane walls, 14, 16 and 24 advantageously possess in the embodiment of Fig. 1 a shared circumferential rim 18 which is designed as a common weld seam. In the second chamber 22 a pasty material is filled in accordance with the invention which consists of a mixture of non-vulcanised silicone oil and silicic acid to which plastic microspheres is added as a light filling material.
The mixture of silicone oil and silicic acid is particularly well suited as a pasty material as a movability and thus an adaptation to the scar area is ensured by the silicone oil while, on the other hand, the silicic acid particles strive for entanglement with each other and thus to form a largely shape-stable unit if no further pressure is exercised on the surface of the second chamber. The plastic microspheres serve to reduce the specific weight of the total mixture and so to make the whole breast prosthesis lighter.
In Fig. 2 a modified form of a breast prosthesis 10 in accordance with the invention is shown in which the rim area of the first chamber protrudes over the rim of the second chamber. Here, a flat hollow is thus formed as is shown in the section in Fig.
2. In the rear view of Fig. 3 it becomes clear that a fill-up valve 26 is integrated in the plastic film 24. The pasty material can be filled into the second chamber 22 through this fill-up valve. In this process, the volume filled in provides for an optimum adaptation of the surface of the second chamber to the scar area of the partially amputated second breast. Advantageously, for example, a breast prosthesis with a second chamber either not filled at all or only partially filled can be released to the trade where the prosthesis can be adapted to the actual scar situation of the wearer by a corresponding filling of the additional chamber with the pasty material. The filling material in accordance with the invention for the second chamber now ensures that this adapts to the scar situation when filled with the pasty material and remains shape-stable in this position.
If the scar situation changes, the prosthesis can be adapted to the new environment without difFculty and will also remain shape-stable after assuming this new shape. In the representation of Fig. 4, only a partially filled second chamber is shown with the degree of partial filling being indicated by the broken line.
If the scar situation changes, the prosthesis can be adapted to the new environment without difFculty and will also remain shape-stable after assuming this new shape. In the representation of Fig. 4, only a partially filled second chamber is shown with the degree of partial filling being indicated by the broken line.
Claims (9)
1. A mammary prosthesis comprising a shell-like body of a plastic with flexible elastic properties, having a first chamber comprising welded plastic sheets and a first filler material, and a second chamber connects to the first chamber, facing the wearer while being worn, and filled with a second filler material comprising a thixotropic material.
2. A mammary prosthesis as claimed in Claim 1 wherein the shell-like body comprises an addition-vulcanised two-component silicone rubber compound.
3. A mammary prosthesis as claimed in Claim 1, wherein the second filler material substantially consists of a mixture of non-vulcanised silicone oil with silicic acid.
4. A mammary prosthesis as claimed in Claim 3, wherein the second filler material further comprises light filler materials.
5. A mammary prosthesis as claimed in Claim 4, wherein the light filler materials comprise plastic microspheres.
6. A mammary prosthesis as claimed in any of one Claims 1 to 5, wherein an outer wall of the second chamber comprises a plastic sheet and has an inlet valve through which the second filler material can be introduced.
7. A mammary prosthesis as claimed in any one of Claims 1 to 6, wherein an outer edge of the shell-like first chamber extends beyond an edge of the second chamber.
8. A mammary prosthesis as claimed in any one of Claims 1 to 6, wherein the edge of the second chamber lies on the outer edge of the first chamber.
9. A mammary prosthesis as claimed in any one of Claims 1 to 8, wherein the prosthesis is designed as a partial prosthesis.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE29516281.3 | 1995-10-13 | ||
| DE29516281U DE29516281U1 (en) | 1995-10-13 | 1995-10-13 | Breast prosthesis |
| PCT/EP1996/004467 WO1997013478A1 (en) | 1995-10-13 | 1996-10-14 | Breast prosthesis |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2204490A1 CA2204490A1 (en) | 1997-04-17 |
| CA2204490C true CA2204490C (en) | 2005-07-12 |
Family
ID=8014131
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002204490A Expired - Fee Related CA2204490C (en) | 1995-10-13 | 1996-10-14 | Breast prosthesis |
Country Status (4)
| Country | Link |
|---|---|
| EP (1) | EP0768068B1 (en) |
| CA (1) | CA2204490C (en) |
| DE (2) | DE29516281U1 (en) |
| WO (1) | WO1997013478A1 (en) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0880951B1 (en) * | 1997-05-03 | 2003-12-03 | Thämert Orthopädische Hilfsmittel GmbH & Co. | Method of producing a prosthesis for the female breast |
| DE19935494C1 (en) | 1999-07-28 | 2000-12-14 | Amoena Med Orthopaedie Tech | Production of breast prostheses, comprises filling skin of polymer film with two-component silicone rubber composition of hollow or microspheres with filler |
| DE20101174U1 (en) * | 2001-01-23 | 2002-05-29 | Amoena Med Orthopaedie Tech | breast prosthesis |
| US7575596B2 (en) | 2001-02-21 | 2009-08-18 | Amoena Medizin-Orthopädie-Technik GmbH | Two-layer external breast prosthesis with self-shaping feature and process for the manufacture thereof |
| DE202004007921U1 (en) * | 2004-05-17 | 2005-09-22 | Amoena Medizin-Orthopädie-Technik GmbH | breast prosthesis |
| DE202008007695U1 (en) | 2008-06-09 | 2009-10-15 | Amoena Medizin-Orthopädie-Technik GmbH | breast prosthesis |
| DE202008008907U1 (en) | 2008-07-01 | 2009-11-19 | Amoena Medizin-Orthopädie-Technik GmbH | breast prosthesis |
| DE202009007115U1 (en) | 2009-05-18 | 2010-06-02 | Amoena Medizin-Orthopädie-Technik GmbH | breast prosthesis |
| DE102010007744A1 (en) | 2010-02-12 | 2011-08-18 | Amoena Medizin-Orthopädie-Technik GmbH, 83064 | breast prosthesis |
| US8926698B2 (en) * | 2011-11-17 | 2015-01-06 | American Breast Care, Lp | Moldable back breast form |
| DE202015007895U1 (en) * | 2015-11-13 | 2017-02-15 | Amoena Medizin-Orthopädie-Technik GmbH | breast prosthesis |
| DE102017116397A1 (en) | 2017-07-20 | 2019-01-24 | Amoena Medizin-Orthopädie-Technik GmbH | Volume-adjustable breast prosthesis |
| BR102018072311A2 (en) * | 2018-10-30 | 2020-05-26 | Pedro Alexandre Da Motta Martins | ARRANGEMENT APPLIED IN SILICONE PROSTHESIS FITTED WITH FIXING ELEMENTS |
Family Cites Families (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE8311438U1 (en) * | 1983-07-28 | Anita-Spezialmiederfabrik Dr. Helbig & Co, 6332 Kufstein | Breast prosthesis | |
| DE6924634U (en) * | 1969-06-13 | 1970-02-05 | Otto Thaemert Textil Und Kunst | CHEST PROSTHESIS |
| FR2487191A1 (en) * | 1980-07-22 | 1982-01-29 | Lavergne Henri | Prosthetic material comprising silicone gels and glass microspheres - for making artificial breasts etc. lighter |
| DE3171145D1 (en) * | 1980-12-12 | 1985-08-01 | Beiersdorf Ag | Mammary prosthesis |
| DE3742352A1 (en) * | 1987-12-14 | 1989-06-29 | Amoena Med Orthopaedie Tech | CHEST PROSTHESIS |
| DE9010426U1 (en) * | 1990-07-11 | 1990-10-04 | Amoena-Medizin-Orthopädie-Technik GmbH, 8201 Raubling | Breast prosthesis |
| DE4211542A1 (en) * | 1991-11-14 | 1993-05-19 | Amoena Med Orthopaedie Tech | Producing breast prosthesis - has soft elastic silicone-rubber mass filled into plastic foil forming inside and outside of prosthesis, adhered by heat activated adhesive layer |
| GB2262041A (en) * | 1991-12-05 | 1993-06-09 | David Williams | Breast prosthesis or enhancer |
| DE9201918U1 (en) * | 1992-02-14 | 1992-06-11 | Amoena-Medizin-Orthopädie-Technik GmbH, 8201 Raubling | Breast prosthesis |
| DE9213880U1 (en) * | 1992-10-15 | 1993-01-07 | Leyerer, Roland, 8208 Kolbermoor | Orthopaedic aids such as extracorporeal breast prosthesis or anti-decubitus cushions |
| DE9306572U1 (en) * | 1993-04-30 | 1993-12-02 | "Amoena" Medizin-Orthopädie-Technik GmbH, 83064 Raubling | Breast prosthesis |
| DE4413076A1 (en) * | 1994-04-15 | 1995-10-19 | Amoena Med Orthopaedie Tech | Process for the manufacture of breast prostheses |
| DE4421516C1 (en) * | 1994-06-20 | 1995-07-27 | Helbig Gmbh & Co Orthopaedisch | Replacement breast for women with amputated breast and mfg. process |
-
1995
- 1995-10-13 DE DE29516281U patent/DE29516281U1/en not_active Expired - Lifetime
-
1996
- 1996-09-16 EP EP96114831A patent/EP0768068B1/en not_active Expired - Lifetime
- 1996-09-16 DE DE59607124T patent/DE59607124D1/en not_active Expired - Lifetime
- 1996-10-14 WO PCT/EP1996/004467 patent/WO1997013478A1/en unknown
- 1996-10-14 CA CA002204490A patent/CA2204490C/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| WO1997013478A1 (en) | 1997-04-17 |
| EP0768068A1 (en) | 1997-04-16 |
| DE29516281U1 (en) | 1997-02-13 |
| DE59607124D1 (en) | 2001-07-26 |
| CA2204490A1 (en) | 1997-04-17 |
| EP0768068B1 (en) | 2001-06-20 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed |