# Patent

## Title
Mounting pad

## Abstract

A mounting pad comprising an adhesive layer (2), said adhesive layer being provided with a removable release liner (3). The release liner being divided into at least two sections (3A, 3B) and each of the at least two said sections of the release liner is provided with one or more score lines (4) thereby defining each section of the release liner as a strip, which renders it possible by a single straight upward pull to peel a release liner in two or more narrow strips, thereby still maintaining an even pull with small force needed to remove the release liner and using only a short pulling distance for removing the release liner from the adhesive surface.

## Background
This application claims the benefit under 35 U.S.C. §371 of International Application No. PCT/DK2007/000278, filed Jun. 8, 2007, which claims the benefit of Danish Patent Application No. PA 2006 00779, filed Jun. 9, 2006, U.S. Provisional Application Ser. No. 60/812,469, filed Jun. 9, 2006, and U.S. Provisional Application Ser. No. 60/876,689, filed Dec. 22, 2006. These references are incorporated herein in their entirety.


FIELD OF INVENTION
The invention relates to a mounting pad comprising an adhesive layer which is being provided with a removable release liner for use in devices applied onto the skin of a patient, particular infusion devices. The invention also relates to a cannula device including a mounting pad comprising an adhesive layer which is being provided with a release liner which can be automatically removed from the mounting pad when the infusion set is applied to a patient. Furthermore, the invention relates to a method for removing a release liner from a mounting pad. Still further, the invention relates to the use of such a mounting pad.
BACKGROUND OF THE INVENTION
U.S. Pat. No. 5,384,174 A describes an adhesive pad for use on the skin, said adhesive pad comprising a release liner, which release liner is removed prior to application of the pad on the skin. The release liner may be one single piece or is provided with score lines or perforations, such that the release liner is divided into two or more sections, such that the release liner may be removed from the adhesive device in two or more pieces.
EP 0239244 A1 describes an injection set for subcutaneous delivery of a fluid to a patient, the injection set being provided with an adhesive sheet comprising a backing layer, an adhesive layer and a removable release liner. The release liner comprises a radial score line starting at the periphery of the release liner and ending on the border of the periphery of a central aperture of the release liner. The release liner is removed manually in one piece before applying the infusion set to the patient.
WO 00/44324 A1 describes an adhesive pad covered by a removable release paper having one or more pre-cut or pre-score lines, and the pre-cut score lines extending as straight lines from the periphery of the release paper inwardly towards the centre of the release paper. The adhesive pad and the removable release paper may have an aperture accommodating a stoma.
With the above mentioned types of products there is a risk that during removal of the release line the adhesive layer will become contaminated by accidental touches by the user. Furthermore, there is a risk of reducing its ability to adhere to the skin. Further, with the known products it can also be difficult to remove all of the release liner without tearing of the liner material, especially in the cases where the release liner is in one piece. Still further, the pull required must be even or smooth in order not to break the release liner during the pull thereby leaving remains of the release liner on the adhesive surface.
International application WO 04/087240 A1 teaches an injection device for placement on the skin of a user and from which a medical fluid such as insulin is injected via a cannula into the user, as the injection device includes a subcutaneous infusion set. The infusion device can be adhered to the skin of the user by means of an adhesive pad that is connected to the lower face of the infusion device and with its adhesive face facing towards the skin of the user. Upon penetration of the skin and subsequent activation of means in the injection device, injection is performed of the medical fluid such as insulin. The release liner covering the adhesive pad is provided with one score line which forms the release liner as a single strip in the form of a spiral.
Scoring the release liner as a long narrow strip gives an even pull and small force is needed to remove the spiral shaped release liner since all it takes is to overcome the adhesive force of the piece of strip being peeled by the user.
However, scoring the release liner as a single strip e.g. in the form as a spiral means that the strip as well as the pull-length becomes relatively long during removal of the release liner before the entire release liner is removed from the adhesive pad.
It is the object of the invention to remedy the above-identified problems and to provide an alternative mounting pad that can be used either alone or in combination with an infusion device, said mounting pad having an easily removable release liner, which can be removed in a single upwardly directed straight movement of the hand, thereby reducing the risk of the user handling the product erroneously. Further, it is an object to use little force in removing the release liner and at the same time to reduce the pull-length during removal of the release liner to get at more straight and upwardly directed movement of the hand.
Moreover, it is an object of the invention to provide an infusion set which is rapid and easy to apply to a patient.
It is further an object of the invention to provide an easy method of removing a release liner from a mounting pad without contaminating or damaging the adhering effect of the mounting pad.
SUMMARY OF THE INVENTION
The present invention relates to a mounting pad comprising an adhesive layer, said layer being provided with a removable release liner, said release liner being divided into at least two sections wherein each of the at least two said sections of the release liner is provided with one or more score lines thereby forming each section of the release liner as a strip.
One end of each section of the release line is provided with means for fastening this one end to an opposite positioned surface. The means referred to could e.g. be a surface having characteristics which makes the surface suitable for adhering to an adhesive placed on the opposite positioned surface or the means could e.g. be of a mechanical kind which can fasten the release liner to the opposite positioned surface.
In a second aspect the invention relates to a cannula device for subcutaneous introduction of a cannula, the cannula device comprising a housing with an upper face plate and a lower face plate and a cannula connected to the lower face plate and a mounting pad placed in connection with the lower face plate and for securing the cannula device to the skin; said mounting pad comprising an adhesive layer being provided with a removable release liner, said release liner being divided into at least two sections and wherein each of the at least two sections of the release liner is provided with one or more score lines thereby forming each section of the release liner as a strip.
The present invention renders it possible by a single straight upward pull to peel a release liner in two or more narrow strips, thereby still maintaining an even pull with little force needed to remove the release liner. Further, the pull-length of the release liner is reduced as the release liner is divided into two or more strips, which is removed simultaneously by the single straight upward pull.
Furthermore, the handling is easy and tearing of the release liner can be avoided. The handling will take place in the same manner as in case the mounting pad is used without an injection device.
In a third aspect the invention relates to a method of removing a release liner from a mounting pad comprising retaining a point of each section of the release liner in the periphery of the mounting pad, removing the release liner by pulling in a single straight pull.
The method of the invention renders it possible to remove the release liner in a single upwardly directed straight movement of the hand, thereby reducing the risk of the user handling the product erroneously. Further, the method of the invention renders it possible to use a small force in removing the release liner and at the same time to reduce the pull-length during removal of the release liner thereby getting a straighter and upwardly directed movement of the hand. Still further, the method of the invention reduces the risk of accidental touch of the adhesive layer by which the ability to adhere to the skin and the risk of subsequently contamination of the skin is reduced.
In a fourth aspect the invention relates to the use of a mounting pad comprising an adhesive layer, said layer being provided with a removable release liner, said release liner being divided into at least two sections wherein each of the at least two said sections of the release liner is provided with one or more score lines thereby defining each section of the release liner as a strip in a cannula device for subcutaneous introduction of a cannula comprising a housing with an upper face plate and a lower face plate and a cannula connected to the lower face plate wherein the mounting pad is placed in connection with the lower face plate and for securing the cannula device to the skin.
DEFINITIONS
The term “mounting pad” as used herein designates an adhesive component having an adhesive layer covered with a release liner, where the mounting pad is for securing a medical device such as a wound dressing, an ostomy appliance or for fixation of a cannula device or an infusion set for injection of insulin in a patient to the skin of a patient.
The term “release liner” as used herein designates a non-adhesive protective layer, which protects the adhesive surface of the mounting pad before use.
The release liner covers essentially the entire adhesive surface and can also extend beyond the boundaries of the mounting pad forming extensions or tabs projecting beyond the boundaries of the mounting pad. The projections facilitate gripping the release liner for removal thereof or securing the same to an application device.
The term “pull-length” as used herein designates a pulling distance which is needed for completely removing the release liner from the adhesive surface.
The term “cannula device” as used herein generally designates a device for the subcutaneous introduction of a cannula of an infusion part of an infusion set or a transcutaneous sensor known per se into the skin of a patient.
The term “infusion set” as used herein in the present context designates a set known per se comprising an infusion part provided with a cannula to penetrate the skin of a user and a connector for connecting the infusion part with a medical device such as an insulin pump. An infusion set has in its assembled form a substantially planar rear side.
The term “projecting part” as used herein designates a part of a release liner or an adhesive surface protruding from the periphery thereof.
The term “score line” as used herein designates a weakening line wherein forces required for breaking the release liner is lower e.g. in the form of a perforated line, a cut-out line or a full score line.
The term “strip” as used herein designates an object shaped with a first end and a second end, such as a ribbon, a band, a half-circle, helix etc.



SHORT DESCRIPTION OF THE DRAWINGS
The invention will now be explained in further detail with reference to the drawing, wherein:
FIG. 1 shows an embodiment of a mounting pad according to the invention;
FIG. 2-9 show different embodiments of a release liner pad according to the invention having one or more score lines;
FIG. 10 schematically shows a sectional view of a cannula device according to the invention having a mounting pad with a release liner during removal of the release liner;
FIG. 11a-11c show another embodiment of a release liner in combination with an adhesive layer.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The invention is explained more in detail with reference to the drawings showing preferred embodiments of the invention. These embodiments are not to be construed as limiting the scope of the present invention as set forth in the appended claims.
FIG. 1 shows an embodiment of a mounting pad 1 according to the invention that is suitable for being arranged on the lower face plate of a cannula device or to be used as such as a plaster or a dressing. The mounting pad 1 according to the invention may be configured in various shapes such as substantially circular, oval, triangular, rectangular, etc. The mounting pad comprises in general an adhesive layer 2, which adhesive layer 2 is a skin friendly adhesive known per se, and a removable release liner 3, which covers the adhesive layer 2. The mounting pad 1 in FIG. 1 is shown from above where it is only possible to see the projecting handle parts of the release liner 3 as the adhesive layer 2 covers the central part, both release liner 3 and adhesive layer 2 is provided with a central aperture 7.
FIG. 2-9 show different embodiments of the mounting pad 1 according to the invention where the release liner is provided with score lines 4 of different shape and location. The embodiments in FIG. 2-9 show different embodiments of a release liner being divided into two sections 3a, 3b, each of said sections 3a, 3b is being provided with at least one score line 4 thereby generating a predetermined pattern, which defines each section 3a, 3b of the release liner as a narrow strip.
FIG. 2 shows an embodiment of a release liner 3 used with a mounting pad 1 according to the invention. The release liner 3 is divided into two sections 3a, 3b and the embodiment of FIG. 2a is provided with two projecting parts, a first projecting part 6a and a second projecting part 6b, in the form of tabs. The embodiment of FIG. 2b has no projecting parts, instead of being “projecting parts” the end parts 6a and 6b of the two sections 3a and 3b just end close to the border of the mounting pad but do not extend the edge of the mounting pad or do not extend no more than the surrounding release liner parts. The two projecting tabs 6a, 6b of the release liner 3 protrude from the periphery of the mounting pad 1 and projects beyond the adhesive layer 2. Furthermore, the two projecting tabs 6a, 6b are situated diametrically opposite each other. The release liner 3 is provided with one uninterrupted score line 4, which has its starting point on the periphery of the release liner 3 in the vicinity of the first projecting tab 6a, said score line 4 extending helically and as an unbroken line from this first projecting tab 6a into the centre of the release liner 3 and continuing from the centre of the release liner 3 as a congruent helically line to the vicinity of the second projecting tab 6b at the periphery of the release liner 3 dividing the release liner 3 in sections 3a, 3b. When the two projecting tabs are seized, only little force and short pull-length is required to remove the release liner 3 from the subjacent adhesive layer 2 and the release liner 3 can be peeled in two separate strips simultaneously from the two ends 6a and 6b, leaving the adhesive layer 2 exposed.
FIG. 3 shows another embodiment of a release liner 3 which also can be used with a mounting pad 1 according to the invention and the release liner 3 is provided with the same features as the embodiment in FIG. 2. Furthermore the release liner is provided with a central aperture 7 and two uninterrupted score lines 4a, 4b extending helically as unbroken lines towards the central aperture 7 of the release liner 3, the first score line 4a having a starting point on the periphery of the release liner in the vicinity of the one projecting tab 6b, and the second score line 4b having a starting point situated diametrically opposite the starting point of the first score line 4a on the periphery of the release liner 3 in the vicinity of the other projecting tab 6a. The two score lines 4a, 4b are arranged in respectively a left-handed and a right-handed spiral and are being parted from each other or situated with a spacing in between defining the wideness of the strips. The score lines 4a, 4b end diametrically opposite each other on the periphery of the central aperture 7. When the tabs are seized, only little force and short pull-length is required to remove the release liner 3 from the subjacent adhesive layer 2 and the release liner 3 can be peeled simultaneously in two individual strips, leaving the adhesive layer 2 exposed.
The release liner 3 covering the adhesive layer 2 of the mounting pad 1 of FIGS. 2-10 is preferably made from siliconized paper or from a sheet of polyethylene which can easily be removed from the adhesive layer 2 without damaging the same.
The score lines 4, 4a, 4b can be in the form of punched or cut dots, slots or interrupted lines which cuts all through the material of the release liner 3, or uninterrupted lines which does not cut all through the material of the release liner but just provide weakened structures. Further, the score lines 4, 4a, 4b defining each section 3a, 3b of the release liner may be formed as a curved score line, such as a helical score line, a sinus curved score line, a straight score line or combinations thereof. The score lines 4, 4a, 4b do not intersect each other. This way, each section 3a, 3b likewise will be shaped according to the score lines 4, 4a and 4b as a narrow strip of curved, helical, sinus or angled shape.
In the embodiments shown in FIGS. 4-9 a first score line 4 proceeds from the first projecting tab 6a to the second projecting tab 6b or from the projecting tabs 6a, 6b to a central aperture 7 and further score lines 4 can extend from the first score line 4 and/or the from the periphery of the release liner 3.
In one embodiment of the invention each strip formed by a section of the release liner 3 has a first end at a projecting tab 6a, 6b and a second end 6c which could be positioned at the periphery or at a central part of the release liner 3 or in between. The first end 6a, 6b can be fixed to a base for fixation of the release liner 3 causing the release liner 3 to be continuously removed when the mounting pad 1 is distanced from the base. This base could e.g. be provided by the packing for the mounting pad 1, or as shown in FIG. 10 for the packing 8 of an infusion set. When a first end of the strips constituting the release liner 3 is fastened to the packing, the first end of strips will be held stationary in relation to the base and automatic release of the release liner will take place when removing the release liner e.g. by pulling a handling part attached to the mounting pad 1, this way the user will completely avoid touching the adhesive layer 2 and handling of the release liner 3 even with reduced dexterity of the hands will become possible.
In use, the release liner is removed from the mounting pad 1 according to the invention by retaining a point of each section 3a, 3b of the release liner at a first end in the vicinity of the projecting tabs 6a, 6b of the mounting pad 1 and afterwards removing the release liner by pulling in a single straight pull.
When pulling the release liner from the adhesive layer in such a single straight upward pull, the release liner is removed in two or more narrow strips. Thereby an even pull with small force needed to remove the release liner is maintained. Further, the pull-length of the release liner is reduced as the release liner is divided into two or more strips, which is removed simultaneously by the single straight upward pull.
In another embodiment the release liner of the mounting pad 1 according to the invention the width of each strip of each section 3a, 3b is less than half the width of the widest point of the mounting pad 1. When the strips are being narrow a reduced force is needed when peeling the release liner from the adhesive layer 2 of the mounting pad 1.
The mounting pad 1 may comprise an aperture 7 and by an aperture is meant a hole or an opening through both the adhesive layer 2 and the release liner 3 of the mounting pad 1. The aperture 7 is located within the periphery of the mounting pad 1 and will normally be located at the central part or near the central part of the mounting pad 1. The aperture 7 can be in any shape or form which allows for e.g. a cannula or a stoma to extend through the aperture 7 such as oval, circular, triangular.
FIG. 10 shows an embodiment of an infusion device according to the invention where a removable release liner 3 covering the adhesive layer 2 of a mounting pad 1 is removed during release of an infusion set 11 from a packaging 8. The infusion set 11 is intended for subcutaneous introduction of a cannula 9 which cannula 9 extends from the proximal side of the infusion set 11. The infusion set 11 is combined with a manual inserter 10 or handling device which inserter 10 makes it possible to handle and insert the infusion device. The mounting pad 1 is placed in connection with a lower face plate of the infusion set 11, and is meant for securing the cannula device which forms part of the infusion set 11 to the skin of the user. The release liner 3 is in this embodiment divided into two sections 3a, 3b by two score lines 4 thereby forming the sections 3a, 3b of the release liner 3 as strips. Each section 3a, 3b forms a narrow helically strip so that the release liner forms a double spiral of the kind shown in FIG. 3. The first end 6a, 6b (only one first end is shown in the figure) of each strip of the release liner 3 closest to the periphery of the mounting pad 1 are connected to an interior surface of the packaging 8 and the rest of the release liner 3 is releasably fastened to the adhesive surface 2. The first end 6a, 6b of the release liner 3 may be fastened to the packaging 8 by gluing, welding or mechanically. When e.g. an inserter (not shown) for automatic insertion of the infusion set is pushed down for connecting to the infusion set 11, the infusion set 11 will be locked to the inserter and at the same time the first end 6a, 6b of each strip of the release liner are pressed down towards the interior surface of the packaging 8 and fastened e.g. with glue, said glue being placed at points corresponding to the first ends 6a, 6b within the interior of the packaging 8. When withdrawing the infusion set 11 from the packaging 8, the release liner 3 is automatically peeled from the adhesive layer 2.
The handling is easy and tearing of the release liner 3 can be avoided. The handling will take place in the same manner as in case the mounting pad 1 is used without an infusion set 11.
In one embodiment the infusion set 11 according to the invention is an infusion set used for infusion of a medicament such as insulin. In another embodiment according to the invention the subcutaneously inserted device is a transcutaneous sensor for measuring the glucose level in a patient.
FIGS. 11a, 11b and 11c show yet another embodiment of a release liner 3 where the start 5 of a score line 4 is completely cut through, actually material has been removed at the start 5 of the score line 4 at the embodiment of FIG. 11a at the periphery of the release liner 3. The start 5 of a score line 4 is defined as a position of a section 3a, 3b of the release liner 3 where the releasing of the section from the adhesive layer 2 initiates. This has the effect that it is easier to initiate the tearing of the score line 4 which then assures an increased success rate for actually removing the release liner 3 from the adhesive layer 2 when pulling the adhesive layer 2 away from the release liner 3. When cutting through the release liner 3 instead of making a score line, the length of the cut through line in the release liner 3 will provide to adjacent edges of release liner 3. The length of the cut through line, i.e. the part where the score line 4 is completely cut through, will normally be less than 2 mm but can have any length.
In the embodiment of FIG. 11a the release liner 3 has an increased surface area compared to the adhesive layer 2, this is shown in FIG. 11a as an increased diameter of the release liner 3 which means that the release liner 3 can be seen from above as a round going strip around the adhesive layer 2 instead of just at the projecting handling parts 6a and 6b. This increased surface of the release liner 3 has the effect that it is possible to provide a start part 5 of a section 3a, 3b close to the periphery of the release liner with little adhesion to the adhesive layer 2 while the section 3a, 3b of the release liner 3 still has a size—especially a certain width—which makes it less likely to be torn when separating the release liner 3 from the adhesive layer 2.
Its therefore possible to at least partly control the adhesion to the adhesive layer by letting a part of each section 3a, 3b extend beyond the adhesive layer 2. One way to do this is to let a defined fraction of the width of the outermost part of each section 3a, 3b extend beyond the adhesive layer 2 i.e. in the longitudinal direction of the strip formed by each section 3a, 3b closest to the outer border of the release liner, the adhesive layer 2 will only cover e.g. half or two-thirds of the release liner section.
In order to make the initiation of the removal of the release liner sections easier, the angle between the two adjacent sections—the angle of the opening provided by the beginning of the score line 4—in the start position should be less than 90°, even less than 30°.
FIG. 11c shows how the score lines 4a and 4b which form the sections 3a and 3b can be positioned below the adhesive layer 2 of the mounting pad.
The features illustrated in FIG. 11a-c can be used in connection with any of the previous described embodiments.

## Claims

1. A mounting pad comprising an adhesive layer, said adhesive layer further comprising a removable release liner, said release liner being divided into at least two sections, each of the at least two sections of the release liner comprising one or more score lines defining each section of the release liner as a strip, wherein each strip of each section of the release liner has a first end and a second end, each first end is provided with means to fasten the first end to a base of a packaging of the mounting pad for fixation of the release liner thereto.

2. A mounting pad according to claim 1, wherein a start position of a score line defining a first end of a section of the release liner as being different from another part of the release liner is completely cut through forming two adjacent separate edges of the release liner.

3. A mounting pad according to claim 2, wherein the two adjacent edges of the release liner form an angle of less than 30°.

4. A mounting pad according to claim 1, wherein the first end of a section is fastened to an interior surface of the packaging for fixation of the release liner thereto.

5. A mounting pad according to claim 1, wherein a part of each section extends beyond the adhesive layer.

6. A mounting pad according to claim 5, wherein a fraction of the width of an outermost part of each section extends beyond the adhesive layer.

7. A mounting pad according to claim 6, wherein the first end of each section is shaped as a projecting part on a periphery of the release liner.

8. A mounting pad according to claim 7, wherein a projecting part extends beyond the adhesive layer.

9. A mounting pad according to claim 1, wherein the width of each section is less than half the width of the widest point of the mounting pad.

10. A mounting pad according to claim 1, wherein at least a part of the score lines comprises punched or cut dots, slots or interrupted lines.

11. A mounting pad according to claim 1, wherein the at least one score line is helically shaped.

12. A mounting pad according to claim 1, wherein each section of the release liner is helically shaped.

13. A mounting pad according to claim 1, wherein the width of each section increases toward the center of the release liner.

14. A mounting pad according to claim 1, wherein the sections are parted from one another by one uninterrupted score line.

15. A mounting pad according to claim 1, wherein each score line has a starting point near the first end of the release liner.

16. A mounting pad according to claim 1, wherein the adhesive layer is a skin friendly adhesive.

17. A mounting pad according to claim 1, wherein the release liner is made of siliconized paper.

18. A mounting pad according to claim 1, wherein the release liner comprises an aperture.

19. A mounting pad according to claim 18, wherein the aperture is placed at the central part of the mounting pad.

20. A mounting pad according to claim 1, wherein said mounting pad is substantially circular or substantially oval.

21. A cannula device for subcutaneous introduction of a cannula comprising:
a housing with an upper face plate and a lower face plate and a cannula connected to the lower face plate and
a mounting pad placed in connection with the lower face plate and for securing the cannula device to the skin; said mounting pad comprising an adhesive layer, said layer further comprising a removable release liner, each of the at least two sections of the release liner comprises one or more score lines forming each section of the release liner as a strip, each strip of each section of the release liner has a first end and a second end, each first end is provided with means to fasten the first end to a base of a packaging of the mounting pad for fixation of the release liner thereto.

22. A cannula device according to claim 21, wherein the first end of each strip is shaped as a projecting part on a periphery of the release liner.

23. A cannula device according to claim 21, wherein the maximum width of each strip is less than half a width of a widest point of the release liner.

24. A cannula device according to claim 21, wherein the release liner comprises an aperture placed in the central part of the mounting pad.

25. A cannula device according to claim 21, wherein said mounting pad is substantially circular or substantially oval.

26. A cannula device according to claim 21, wherein the cannula device is an infusion set.

27. A cannula device according to claim 21, wherein the cannula device is a transcutaneous sensor.

28. A method of removing a release liner from a mounting pad according to claim 1, comprising
retaining a point of each section of the release liner at the first end of the mounting pad
removing all sections of the release liner by pulling in a single pull.