Patent Application
20050256572
This application claims priority to German Patent Application Serial No. DE 202004007921.6 filed May 17, 2005, which is hereby incorporated by reference in its entirety for all purposes.
The present application relates to a breast prosthesis.
A method is known, for example from DE 27 01 627 A 1, of manufacturing breast prostheses from shell-shaped bodies welded into plastic films, modeled on the shape of the breast and from an addition cross-linked two-component silicone rubber mass. The prostheses manufactured with this method are almost ideal copies of the natural breast in their appearance and in their behavior due to the elastic softness, the movement, the consistence and the weight of the material used.
The breast prostheses are attached to the breast of the wearer in a manner as nonslipping as possible. For this purpose, it is known, for example from EP 392960 A 1, to provide breast prostheses of the type first named with a peripheral shoulder formed by a step on its rear side inside a peripheral lip-shaped rim, with adhesive strips or adhesive pieces being fastened to said peripheral shoulder which cooperate with the adhesive regions of strips fastened to the body of the woman by skinfriendly adhesive means such that the prosthesis is connected to the holding strips adhering to the body and can be released from them again. A hook and loop connection is, for example, provided as the fastening means.
Breast prostheses, to the extent that they are not designed to be self-adhesive or in connection with adhesive strips, are usually worn in special brassieres with an integrated pouch or also partly directly on the skin, which can result in unpleasant heat accumulation with the formation of perspiration due to the restricted exchange of air beneath the prosthesis and the poor heat transport.
Prostheses are also already known which are made in two layers and in which an inner side facing the breast has a chamber which is filled with a liquid, preferably a thixotropically set liquid. When such a breast prosthesis is worn, an unwanted formation of blisters occurs to a greater extent due to the aforesaid formation of heat accumulation and due to a corresponding discharge of perspiration in the region of the liquid. This mainly occurs due to the interaction between the plastic film usually consisting of polyurethane and the liquid which does not have a fixed connection to the film and to the mechanical deformation of the film and the liquid during wear. This phenomenon is amplified by the increased humidity which develops between the breast prosthesis and the body. The formation of blisters in particular occurs with a mixture of thixotropic liquids with light fillers in the part of the two-layer prosthesis facing the body.
It has furthermore been observed with breast prostheses that visible blisters occur close to the prosthesis surface. In particular with silicones which are provided with light fillers, such as has become increasingly usual over the past few years, but also with prosthesis chambers which are filled with liquid, a tendency toward blister formation has become increasingly visible when the prosthesis is subject to large air pressure fluctuations, e.g. due to local altitude differences.
Such a blister formation is due to the fact that silicones tend to absorb gases, and thus also air, up to the respective saturation limit and in dependence on the environmental pressure. This can be compared with an absorption capability of a sponge. On a change in the ambient pressure, the absorbed gas volume again attempts to adapt in accordance with the environmental pressure, which can result in clearly visible gas blisters close to the prosthesis surface on an air pressure reduction. To prevent this beading of the gas in the finished prosthesis, the silicones are “evacuated” before the processing to ensure that no more air is located in the material. It can nevertheless be observed that corresponding air accumulates after some time in the breast prostheses even if they were absolutely air-free directly after the manufacture, that is if no blister formation was able to be observed. This air accumulation with possible later blister formation is in particular observed in the customary breast prostheses in which the plastic films consist of polyurethane films when they are exposed to larger fluctuations in air pressure, for example due to the altitude of the location of use.
It is one object of the present application to further develop generic breast prostheses such that a blister formation inside the breast prosthesis is reduced.
This object may be solved by a breast prosthesis comprising bodies welded in plastic films, modeled on the shape of the breast and made of a silicone rubber mass or of another soft-elastic material, where at least some of the plastic films comprise gas-tight material. Accordingly, no air or water vapor can penetrate into the silicone at the corresponding interface due to the created gas barrier. An exchange of air resulting in blisters can thus also not occur on changes in air pressure.
In one embodiment, the breast prosthesis can have a plastic film as a special form of a gastight plastic film which is impermeable to water vapor or which inhibits water vapor at least at its side facing the body. Films with a water vapor block can therefore be used here. This is in particular of advantage with multi-layer prostheses, preferably two-layer prostheses, with here—in accordance with an embodiment variant—only the layer close to the body being surrounded at least partly by a plastic film impermeable to water vapor. At least the film coming into contact with the body should here be impermeable to water vapor. In accordance with an alternative embodiment, however, the whole layer close to the body can also be enveloped by means of the plastic film impermeable to water vapor or inhibiting water vapor in the two-layer prosthesis.
Another gas-tight embodiment variant consists of the fact that the breast prosthesis is at least partly air-tight, i.e., that an air-tight plastic film has been used here.
The gas-tight plastic films can consist at least partly of one or more of the following components:
Nano-composites can also advantageously be added to the raw materials of the gas-tight plastic films. Furthermore, the gas-tight plastic films can support a plasma coating with SiOx or be evaporation coated with aluminum. The materials can also be combined with other plastics, for example with polyethylene (PE), for the gas-tight plastic film.
The materials for a plastic film impermeable to water vapor can consist at least in part of plastic blends such as a polyurethane blend with polyethylene, polypropylene or other polyolefins and/or blends of pure polyolefins. It is particularly advantageous to use the plastic film impermeable to water vapor in two-layer prostheses where the second layer close to the body contains a thixotropic liquid, very advantageously a thixotropic liquid with light fillers.
Further features and details and advantages will be explained in more detail with reference to an embodiment shown in the drawing. There are shown:
The breast prosthesis 10 shown in
In the embodiment shown here, the plastic films 16 and 14 each consist of a plastic which represents a gas barrier and thus does not permit a saturation of the silicone with air or at least makes it considerably more difficult.
The embodiment in accordance with
In accordance with a further embodiment variant not shown in any more detail here, the polyurethane layer 12 could also be replaced by a plastic film which is impermeable to gas.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20 2004 007 921.6 | May 2004 | DE | national |
