Patent Application
20090326430
This invention relates to an adhesive flexible film suitable as a surgical drape or as a wound care dressing. In particular, the invention relates to a film dressing comprising a flexible film with opposite inner and outer surfaces, the inner surface being provided with an adhesive. A removable release liner is provided to protect the adhesive against undesired sticking to other items, and a removable support layer is bonded to the outer surface of the flexible film to support the flexible film and to maintain a smooth and un-wrinkled surface of the flexible film. The film dressing comprises a tap which is bonded to the support layer. The tap facilitates a users grip and thus facilitates a user in separating the support layer from the flexible film when the flexible film has been applied to a surface, e.g. to a wound of a patient. The invention further relates to a method of applying such a film dressing, to the use of such a film dressing in negative pressure wound treatment, and to a method of producing such a film dressing.
Flexible film dressings for wound treatment and in general for surgical drapes are known in the art. Typically, the known film dressings have a flexible film with a major surface coated or covered with pressure sensitive adhesive. A removable release liner covers the adhesive, and a flexible second film is bonded to the first film. The second film is suited to ‘carry’ the first film, making it easier to apply very thin, flexible and conformable first film coated with adhesive. The second, in general more rigid film is also called the support layer. After removal of the release liners, the construction is applied to the skin. In a second step, the support layer is removed while the first film remains adhered to the skin. Tabs, handle bars or similar application systems attached at the edge of the support layer to allow easy removal of the support layer are typically applied. A tap typically has an adhesive coated edge to attach the handle bar to the support layer, but can also have a non-adhesive coated part to act as a finger-lift. Other methods of sealing the tap to the support layer are possible. In prior art, tabs are mostly square or rectangular, laminated or otherwise constructed along the machine direction during conversion.
When the film dressing is applied, the first film is applied to the skin and the support layer is subsequently removed by pulling the tab. When pulling the tab, the first and second films must separate without lifting off the first film from the skin. It is important that the first flexible film stays completely adhered to the skin since wrinkles or air bubbles and channels between the skin and the first film may cause infection, maceration, or lead to decubitus. In particular in combination with negative pressure wound care, it is important to avoid separation of the first film from the skin of the patient, otherwise it will be difficult to sustain an adequate negative pressure beneath the film.
To prevent separation of the flexible film from the skin of a patient during separation of the support layer from the flexible film, one attempt has been to increase the bonding strength between the flexible film and the skin. This, however, may have a drawback in a later stage when the flexible film is to be removed from the skin, e.g. after ended treatment. Another known solution is to reduce the strength between the flexible film and the support layer. This, however, has the drawback that the support layer may separate from the flexible film too early and the flexible film may thereby wrinkle.
It is an object of the invention to improve flexible film dressings and to facilitate separation of the support layer from the flexible film.
According to a first aspect, the invention provides a film dressing with a tap which is bonded to the support layer in an interface zone which has at least one non-linear edge.
In a traditional system in which the support layer and tap are bonded along a straight edge, the force by which the flexible film and support layer are separated is essentially perpendicularly to the straight edge.
A non-linear interface zone may, during a users pull in the tap, cause pull directions which vary along the interface zone. Surprisingly, it has been found that such variations of the pull direction facilitate an easier separation of the support layer from the flexible film.
In this regards, a non-linear shape when used in this application, e.g. as describing the interface zone in the first aspect of the invention may embrace a wavy shape, a zigzag shape, or in general any shape which is not defined by one straight line, e.g. a sine-shape etc. furthermore, a non-linear shape may embrace more than one edge of the interface zone is non-linear. In one embodiment, the non-linear interface zone comprises one edge extending along a straight line and an opposite edge being non-linear.
The interface zone is defined as the zone in which the tap is bonded to the support layer. This bond may be continuous or discontinuous, i.e. broken into several bonded portions. The bond could be established by an adhesive, by welding the tap and support layer together, or the tap and support layer could be formed in one piece, e.g. from a single plate of a sheet material.
The interface could be located remote from edges of the film dressing. In this case, the non-linear shape could be provided by a non-linear adhesive layer or a non linear welding between the tap and the support layer. Alternatively, the interface could be located directly adjacent an edge of the film dressing, or at least adjacent an edge of the support layer and tap. This edge of the support layer, and tap or of the entire film dressing could be a non-linear edge, e.g. an edge having a shape which is similar to the shape of the interface zone.
In one particular embodiment, the interface zone forms a plurality of discontinuous bonded portions in which the support layer is attached to the tap and which are interrupted by non-bonded portions. Surprisingly, it has been found that such an interface zone allows for an even easier removal of the support layer after the flexible film is adhered to the skin, and the risk of lifting the flexible film off from the skin during removal of the support layer can therefore be further reduced. The bonded portions could be areas in which the tap is attached to the support layer e.g. by an adhesive, by welding etc, or the tap and support layer could be formed in one piece, e.g. from a piece of a sheet material in which a number of holes are punched out to form a plurality of areas which form transitions between the support layer portion of the sheet and the tap portion of the sheet. In this embodiment, the support layer portion of the sheet coextends the flexible film whereas the tap portion extends beyond the flexible film. The sheet could be folded in the transition between the tap and the support layer.
The flexible film could be made of polyurethane PU, PVC, EMA, silicone and other materials which are flexible and conformable to the skin, or the flexible film could be made of combinations between the mentioned materials, e.g. combinations between the mentioned materials and other materials.
Preferably, the flexible film is provided with a permeable structure allowing the skin to which the film is applied, to breath. On one surface, the film may be coated with an adhesive compound, e.g. a hydrocolloid adhesive, an acrylate adhesive, or a silicone adhesive. In one embodiment, the adhesive is breathable. On the opposite surface, the flexible film is in adhesive or electro static contact with a support layer which is preferably rigid relative to the flexible film. The support layer could be made from PE, PET, PP, paper, coated paper or other film materials that provide support to the flexible film. The support layer may be partly or fully coated with an adhesive to bond against the flexible film. The support layer may also provide dimensional stability during adhesion coating, conversion, assembly and handling. The flexible film could be laminated, cast, extruded or co-extruded onto the support film. In one embodiment, the support layer is less elastically deformable than the flexible film. The support layer could be provided with a thickness similar to the thickness of the flexible film or in the range of 0.5-10 times the thickness of the flexible film.
The removable release liner should protect the adhesive characteristics of the flexible film and could be of any kind known in the art.
The tap could be formed as a rectangular laminated or otherwise designed strip which is easily accessible for the user. To improve the users grip in the tap, the tap could be formed with a surface with a friction which is relatively large compared with the surface friction of the support layer. The tap may further be formed with protrusions, knobs, ribs or other structural features which enhance the users grip. The tap could also comprise a through hole enabling a solid finger grip, or the tap could be provided with a string which further facilitates gripping.
In order further to facilitate separation of the support layer from the flexible film, the interface zone could be arranged along a non-linear edge of at least one of the taps and the support layer or along an edge formed by all layers of the film dressing, i.e. an edge formed by the release liner, the flexible film, the support layer and the tap. Again, non-linear may embrace e.g. a zigzagged edge or a wave-shaped edge. In this embodiment, it may be an advantage to provide the interface zone in the foremost projecting points of the non linear edge, i.e. in a part of the edge which is furthest away from a centre portion of the film dressing, e.g. in portions of the edge with a larger distance to a geometric centre of the film dressing while other portions with a shorter distance to the geometric centre of the film dressing could be un-bonded. If the edge is wave-shaped, the interface zone could be located at the wave crests while the non-bonded portions could be at the wave troughs.
The interface zone may e.g. constitute in the range of 10-90 percent of the total length of the non-linear edge. If the interface zone comprises discontinuous bonded portions, the above-mentioned range is the total length of all the portions relative to the total length of the non-linear edge.
The invention may facilitate the user to cut the original dressing into smaller dressings by providing the non-linear edge with a pattern of periodically repeated projections. As an example, the non-linear edge may form a wave-shaped pattern or a zigzagged pattern with repeated projections or wavy crests.
The interface zone may e.g. constitute in the range between 5 and 85 percent of the area of the waves or projections, e.g. in the range between 25 and 65 percent. This means that the tap is bonded to the support layer in an area which constitutes the above mentioned portions of the total area of the waves or projections. If the interface zone comprises discontinuous bonded portions, the sum of the bonded areas is within the above-mentioned areas of the total area of the waves or projections.
In one embodiment, the film dressing comprises at least two opposite non-linear or wave-shaped edges each forming an interface zone, e.g. with a plurality of discontinuous bonded portions. In another embodiment, the film dressing comprises at least two non-linear or wave-shaped interface zones located in the vicinity of opposite edges of the film dressing. The film dressing may further comprise one individual tap in connection with each wave-shaped interface zone.
An intermediate release liner may cover an intermediate portion of the adhesive and first and second edge liners may cover edge portions of the adhesive on opposite sides of the intermediate portion. The discontinuous bonded portions could be arranged along edges of the edge portions.
To facilitate that the separation of the support layer from the flexible film takes place from a narrow portion of the edge, e.g. from a corner point, the film dressing may have a tap with a protruding gripping element forming part of the free portion. As an example, the free portion may have a wave-shaped edge, or a protrusion arranged on the tap. In one embodiment, the film dressing comprises an attached string by which the user may grip the tap and use it for separation of the support layer from the flexible film.
In another embodiment of the invention, the tap comprises two free portions extending in opposite directions from the interface zone.
Under certain conditions, it may happen that the adhesive provided on the flexible film come in contact with the tap or it may happen that the adhesive provided on the flexible film come in contact with the adhesive which bonds the tap to the support layer. Unfortunately, this would make it difficult for the user to separate the support layer from the flexible film. To avoid this potential problem, the film dressing may, on an inner surface of the tap which faces the support layer, comprise a non-stick surface portion on which the adhesive of the flexible film is prevented from adhering. The non stick surface portion could extend beyond the other layers of the film dressing, or at least extend beyond the flexible film and the adhesive provided between this film and the release liner. The non-stick surface portion could be directly adjacent the interface zone and it may comprise a layer of a material with a silicone coating.
In a second aspect, the invention provides a film dressing comprising
The film dressing according to the second aspect of the invention may be combined with any of the features disclosed with reference to the first aspect of the invention, and the discontinuous bonded portions may thus replace the non-linear edge. Alternatively, the discontinuous bonded portions may be combined with the non-linear edge.
In a third aspect, the invention provides a film dressing comprising
The protrusion may ensure that the pull in the tap is initiated at a specific location along the interface zone, and it may thereby ensure that the separation of the flexible film from the support layer is initiated at a specific location, e.g. at a corner or at a location with a less strong bonding between the flexible film and the support layer.
The gripping edge could e.g. be wave-shaped or the gripping edge could form a plurality of protruding taps which can be grabbed individually by a user. In particular to facilitate that the user cuts the film dressing into smaller pieces, it may be an advantage to provide a wave-shape or a plurality of protruding taps, so that the user can cut the film dressing into several pieces each having a tap with a free portion forming a protrusion.
In a fourth aspect, the invention provides a film dressing comprising
In this embodiment, the string replaces or accompanies the protrusion according to the third aspect of the invention. The string could be a wire, cord, lead or a strip of tape or a handle bar device, e.g. made of plastic and which extends from the free portion of the tap, or the string may simply constitute the free portion of the tap, so that the tap is completely bonded to the support layer in the interface zone and comprises a string extending freely therefrom and by which the user may grasp the tap.
In a fifth aspect, the invention provides a method of applying a film dressing to a surface, said method comprising the steps of: providing a film dressing in accordance with the above description, removing the release liner from the flexible film, applying the flexible film to the surface, and removing the support layer from the flexible film by a pull in the tap. The film dressing could be applied to a wound e.g. in connection with a negative pressure wound treatment as disclosed in EP0620720.
In a sixth aspect, the invention provides a method of fixating a suction hose to a wound, the method comprising arranging a hose in a desired location relative to the wound and applying a film dressing in accordance with the above-mentioned way of applying the film dressing to a surface.
In a seventh aspect, the invention provides the use of a film dressing of the above described kind as a surgical drape.
In an eight aspect, the invention provides a method of manufacturing a film dressing of the above-mentioned kind. The dressings according to the invention may be formed in various ways. For example, the adhesive layer may be applied to the flexible film or to the release liner by a die coating, a screen coating, a curtain coating, or by extrusion. Alternatively, the adhesive layer can be coated in a first step and laminated into the construction in a second step. The adhesives may be hot melt adhesives, UV or electro-beam curable, solvent or emulsion based. Tabs may be created by folding or by applying an adhesive strip or by welding such a tab. The laminated films may be formed by laminating pre-fabricated film sheets which have been formed by any suitable method such as by casting or by blow extrusion. Alternatively, the laminates may be formed by co-extrusion or by extrusion lamination techniques. Preferentially, all components of the dressing are laminated together from roll material in a machine direction. Individual dressings are then made by for example rotary die, or flatbed or laser cutting. All steps may be combined in one machine pass. Alternatively individual components or several components are combined in separate steps. In the assembly process, material may be removed.
A preferred embodiment of the invention will be described in further details with reference to the drawing in which:
Referring to
The film dressing shown in a top view in
The cross-sectional view in
The cross-sectional view in
| Number | Date | Country | Kind |
|---|---|---|---|
| PA 2006-01226 | Sep 2006 | DK | national |
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/EP2007/060040 | 9/21/2007 | WO | 00 | 8/19/2009 |
