Link:  Pharm/Biotech Resources

Title:  Light occlusive patch

United States Patent:  6,890,551

Issued:  May 10, 2005

Inventors:  Lenz; Dirk (Hamburg, DE); Mayan; Robert (Buxtehude, DE); Timm; Jürgen (Seevetal, DE); Trotter; Sebastian (Buchholz, DE)

Assignee:  Beiersdorf AG (Hamburg, DE)

Appl. No.:  243016

Filed:  February 2, 1999

Occlusive plaster consisting of at least one layer of a foam material which is provided on the lower side with a skin-compatible self-adhesive layer.

The invention relates to a self-adhesive rapid dressing which is used as an occlusive plaster.

One of the uses of occlusive plasters is to treat strabism (squint), especially in children. For this treatment the occlusive plaster is stuck in particular over the leading, working eye of the afflicted patient in order to bring about fixation of the visually weak eye.

One example of a known and commercially available occlusive plaster is the "Elastopad®" from Beiersdorf AG, Hamburg, Germany. The eye plaster consists of a transversely elastic woven viscose backing, a three-ply opaque light protection web, which is partially applied to the backing, and a zinc oxide-filled rubber composition as pressure-sensitive adhesive composition. This plaster features relatively good air permeability and water permeability but it is light-blocking (fully occlusive) only when sited over the eye with very great care. Further attributes of the plaster relate to the good fit, secure adhesion and conformability.

In addition there are further products in existence which generally employ a woven or nonwoven as the backing, which are punched out in the form of an occlusive plaster, and where there is—applied centrally—an absorbent pad which is provided with a more or less transparent liner.

However, the known plasters have a multiplicity of disadvantages.

For instance, the desired full occlusiveness is often not ensured. Owing to the relatively small and incomplete coverage of the backing with the light protection web, the lateral incidence of residual light is not ruled out, especially if the product is not sited precisely over the eye. This effect can be intensified further by the patient's movements and the associated shifting of the plaster.

Furthermore, the multi-ply structure of the occlusive plaster, composed of different materials, makes the production process complex and therefore relatively expensive.

DE 40 07 891 A1 discloses a backing material for medical purposes comprising a laminate having a first polymeric film layer, a second polymeric film layer which is produced on the first layer, and a third layer comprising a macroporous textile material which is embedded at least partially in the second layer. The first and second layers of this laminate can consist of polyurethane. The foaming of the individual layers, however, is not proposed.

The object of the invention was to provide an occlusive plaster which avoids the disadvantages of the prior art.

This object is achieved by an occlusive plaster characterized in accordance with the main claim. The subclaims relate to advantageous developments of the plaster and to a process for producing the occlusive plaster of the invention.

The invention relates accordingly to an occlusive plaster which consists of at least one layer of a foamed material and which is provided on the lower side with a skin-compatible self-adhesive layer.

To ensure occlusiveness adequately, the layer thickness of a one-layer occlusive plaster must be adequate—that is, at least 400 μm.

In one advantageous embodiment the occlusive plaster consists of a top layer made of a foamed material and an inner layer made from a foamed material, the latter layer being provided on the lower side with a skin-compatible self-adhesive layer.

It has also been found advantageous if an internal contour is printed in black on the top layer. Even with relatively low layer thicknesses of the top and/or inner layers, this contour, printed in black, ensures full occlusiveness.

In an alternative embodiment there is a black-coloured interlayer likewise formed of a foamed material between the top layer and the inner layer, over the entire area.

The foamed material employed preferably comprises PU, PP, PE or PVC foams, with particular preference being given to PU foam made of polyesterurethane.

The foamed material also preferably has a density in the dry state of from 0.03 to 0.8 g/cm³, in particular from 0.1 to 0.3 g/cm³.

In this case it has been found advantageous if the foam material has a layer thickness of from 0.2 to 2.0 mm, in particular from 0.3 to 0.8 mm. The smaller layer thicknesses in particular are achieved by calendering the foam material, causing it to undergo compression.

To both increase the foam density and decrease the cost of the material employed it is possible with advantage to add fillers, such as calcium carbonate, kaolin and/or alumina, to the foamed material.

To increase the mechanical stability in the lengthwise and transverse direction and to increase the tear propagation resistance of the foams, a layer of unfoamed PU can be applied to the top layer or a two-dimensional textile structure (nonwoven, knit, woven) can be embedded in the top layer.

Furthermore, an absorbent pad smaller than the adhesive area can be applied to the adhesive side of the inner layer, preferably in the middle of the backing material.

Finally, a further advantageous embodiment of the plaster is that in which the self-adhesive side is provided with at least one peelable cover sheet as a protective covering.

The inventive concept then embraces a process for producing an occlusive plaster, consisting of the following process steps.

The first step involves introducing the top layer, the inner layer and, if present, the interlayer in each case in a mixture of aqueous aliphatic dispersions of polyesterurethanes.

A foaming agent (preferably ammonium stearate, Stokal products from Stockhausen) and a dye are added to each of the mixtures.

In addition to the black-coloured interlayer, preference is given here to a skin-coloured top layer and a white inner layer.

The respective mixtures are brought to the desired degree of foaming by blowing air into them.

The coating operation begins with foam for the top layer being coated out onto a release paper and then dried.

The release paper—or, to be more precise, the particular form of the surface of the release paper—causes the dried foam and/or the top layer to take on a particularly soft, silky appearance.

Where an interlayer is provided, the foam for the interlayer is coated out onto the dried top layer and then dried.

The foam for the inner layer is coated out in the same way as for the top layer and, if appropriate, the interlayer and is likewise dried.

To produce the actual occlusive plasters, the adhesive coating is applied first of all and then the occlusive plasters are punched out.

Optional operations include the application of an absorbent pad centrally to the inner layer, and the sealed enclosure of the individual plasters.

The occlusive plaster of the invention has a host of advantages over the prior art plasters.

The full occlusiveness required of the occlusive plaster can be realized optimally, in particular, in the case of the advantageous embodiment with the black-coloured interlayer. The entire area of the plaster is light-blocking or can be made so.

Top layer, inner layer and interlayer can be produced from a single material, which is very cost-effective and minimizes the complexity.

The conformability of the plaster and the softness of the surface are unsurpassed and are ideally suited to use on the eye.

Claim 1 of 1 Claim

1. Process for producing the improved elastic light occlusive eye patch having an upper side and a lower side which is provided on the lower side with a skin compatible self-adhesive layer, consisting essentially of a top layer, an inner layer and a black colored interlayer, all layers being made of a foamed material, wherein the foamed material comprises aqueous aliphatic dispersions of polyesterurethanes, wherein the process for producing the improved elastic light occlusive eye patch comprises the following process steps:

a) preparing the top foam layer, the inner foam layer and a foamed interlayer, for each foam layer, a mixture of aqueous aliphatic dispersions of polyesterurethanes is combined with a foaming agent and a dye;

b) foaming the respective mixture to the desired degree by blowing air into it;

c) coating the foam for the top layer onto a release paper, with subsequent drying;

d) coating out the foam for the interlayer onto the dried top layer, with subsequent drying; and

e) coating out the inner layer on the top layer or interlayer, with subsequent drying, to provide an assembly of foam layers having a thickness of 2 mm or less.

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