Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
1998-03-06
2002-02-12
Dodson, Shelly A. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
C424S445000, C424S447000, C424S448000, C424S449000, C428S078000, C428S343000
Reexamination Certificate
active
06346266
ABSTRACT:
The invention relates to the further development of known plasters.
It is common practice to use plasters for covering wounds. The plasters consist of a support material which is provided on one side with a self-adhesive layer. In most cases, a wound covering is applied to this self-adhesive coating. In order to ensure that handling is straightforward, the self-adhesive coating is, furthermore, covered with a protective layer made of film, for example. Individual plasters are then punched out in various shapes from a roll and are sealed in paper. The punched shapes are geometrically regular forms such as rectangles or circles, for example.
German Utility Model DE U 74 20 413 describes a badge which on its visible surface has a two-dimensional or three-dimensional reproduction of at least one figured representation which is familiar to and preferably popular with children, which badge is characterized in that it is designed as a wound plaster having a cover layer, made of material which is gentle on wounds and/or promotes healing and/or breathes, which forms a support material for the figured representation and has regions that can stuck to the skin.
However, this type of representation always involves a conventional type of impression. No special optical effect can be achieved with it.
However, in general, plasters have predominantly no impression on the opposite side of the plaster support material from the body.
Only quite recently have comparable plasters been found on the market. Thus so-called Junior-Strips®, bearing an impression on a conventional form of plaster, are sold, this impression enjoying very great popularity especially among children. This impression usually consists of the representation of a cartoon character.
In spite of their undisputed advantages when used to cover relatively small wounds, known types of plaster are rather unpopular with adolescents and children, since there are negative associations such as pain, possibly bleeding and injury associated with the plaster.
In addition, conventional plasters have a dull appearance and are therefore unattractive to children.
In order to raise the visual stimulus for children and especially for adolescents, the company Kendall Futuro markets in the U.S., under the brand name Curad®, a plaster having a PVC film as support. The upper side of the support material carries over its full area an imprint which is most probably applied in random flexographic printing and which is intended to have afterglow (phosphorescent) properties. Tests with this plaster, however, have shown that the imprint is extremely short-lived and, moreover, has only a very weak afterglow.
In addition, the company Siebdruck Bischoff in Muggensturm produces long-afterglow safety guidance systems and safety signs. The support materials include 100 &mgr;m thick PVC films with a self-adhesive coating that are printed by sheet-fed screen printing with a coating system comprising a pigment having long-afterglow properties. The pigments employed in this system are based on alkaline earth metal aluminates that contain rare earth elements.
The object of the invention was, in particular for adolescents and children, to provide a plaster which is no longer unpopular with the said groups of individuals but which, instead, they find very interesting, and to do this with the simplest of means. In particular, the invention is directed towards the possibility of being able to use the plasters according to the invention to cover open wounds on the surface of the skin, in order to prevent unwanted consequences such as infection.
This object is achieved by a plaster as described in more detail in the claims.
The plasters comprise a support material, preferably a polyethylene film, which over all or part of its top side has a long-afterglow imprint comprising a coating system into which a long-afterglow pigment has been incorporated, and is provided on the bottom side with a dermatologically compatible self-adhesive layer.
Besides the said films, however, all materials suitable for the skin, for printing and for coating with a self-adhesive composition can be used as the support material. Other than films, supports of outstanding suitability include wovens, nonwovens or composites of these materials, with the proviso that the requirements placed on the support material—namely flexibility, printability and confirmity—are met.
In addition, the support material is advantageously white in coloration and/or has a white underlay or imprint.
In a preferred embodiment, the plaster is provided with a wound pad on the adhesive side of the support material, the wound pad being smaller than the bond surface and being applied in the centre of the support material.
In order to protect the wound pad against contamination and dirt, the support material side which is rendered self-adhesive may be provided with at least one tear-off cover sheet as a protective covering.
In a further preferred embodiment, the geometric shape of the support material substantially coincides with the outer contours of the imprint situated on the top side of the support material.
The coating system used is preferably a transparent, thermally drying coating system obtainable, for example, from the company SICPA Druckfarben GmbH, Backnang. Also suitable, however, are electron election beam crosslinking coating systems or UV coating systems.
The long-afterglow pigment is mixed into the coating system, especially with a proportion of 1:1. The pigment is incorporated into the coating system, with or without the use of a thickener, so as to ensure optimum homogeneity and immobility.
The afterglow intensity of the said mixture depends on the particle size distribution and on the amount applied to the support material. The amount applied is a function of the design of the screen that is used for printing.
The long-afterglow pigment incorporated into the coating system is preferably a zinc sulphide compound doped with copper ions, especially Lumilx® Effekt grun N-L (special-effect green N-L) from the company Riedel-de Häen. Pigments of this kind are able to absorb energy and to emit it again with a time delay, in the form of light quanta.
Also suitable, in general, are the long-afterglow pigments from the Lumilux® N group of the company Riedel-de Häen, which are polycrystalline, inorganic zinc sulphides or alkaline earth metal suphides. The latter in particular, which are able to bring about a red or blue afterglow effect, must be protected against direct contact with moisture through the use of an appropriate non-aqueous binder.
In order that the pigment may be employed, the long-afterglow pigment must meet the requirements for a medical product.
According to DIN 53160, no colorant and no optical brightener may pass from the respective medical product into the mouth, onto the mucous membranes or onto the skin. Therefore, the pigment must be fast to saliva and sweat.
DIN 71-3:1994 places a certain upper limit on the content of heavy metals. Since, however, it cannot be ruled out that the plaster of the invention will get into the mouths of small children, EN 648:1993, which represents a supplement to DIN 71-3, should also be observed, as is recommended in chapter XLVII of the BGVV Recommendation “Play products made from plastics and other polymers and from paper and cardboard” for toys which are intended to be, or which might foreseeably, taken into the mouth.
Finally, the pigments should also satisfy the European provisions regarding toy safety (EU Directive 88/378/EC).
In order to be sure of complying with the requirements set out above, the top side of the support material, which is where the long-afterglow imprint is located, should be provided with a mechanical barrier. The said barrier is preferably a plastic film or a varnish coat, such as a cationically curing UF flexgraphic print varnis. Alternatively, this protective layer can be produced by applying the printed image of the long-afterglow imprint in mirror image, by the counterprint process, and then attaching it to a laminate.
As a further prefe
Bosse Jürgen
Bruss Witta
Leutz Reiner
Beiersdorf AG
Dodson Shelly A.
Norris & McLaughlin & Marcus
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