SE530097C2 - Component for fixing a medical device against skin - Google Patents

Abstract

The top side of the fastener (2) includes an attachment region (5) for the article (1) or a part thereof, this region being located at least 5 mm from two or more opposing edges of the fastener. The adhesive coating (3) comprises a soft, skin-compatible, pressure-sensitive adhesive having a creeping removal rate of more than 0.05 mm/minute at a load of 0.2N/25 mm. The attachment region is located at least 5 mm from the opposing edges of the fastener subjected to tensile and/or shear forces during use of the article. The fastener comprises a carrier (4) with an adhesive layer on its bottom side.

Description

25 530 09? the adhesion of the adhesive layer is considerable and adhesives with hard adhesives can seldom be attached more than once.

From SE-C2-510 907, WO 03/079919 A1 and PCT / SE2006 / 000025 it is known to use instead self-adhesive, soft adhesives, which are very gentle on the skin and when peeled off essentially only take with them dead skin cells. The reason for the skin-friendly properties of these soft adhesives is of course that the adhesive does not adhere as hard to the skin, but the softness of the adhesive layer means that the adhesive, unlike hard adhesives, has a very good ability to follow the skin's imperfections.

This means that the contact surface for the adhesive layer becomes much larger than for hard adhesives, which in turn means that a sufficiently high total adhesion of a medical device to the skin can still be achieved. The low adhesion to skin cells of soft adhesives means that they can be removed from the skin without taking any healthy skin cells with them to any appreciable extent. In addition to the fact that this means that they can be removed without pain for the user, the lack of skin cells on a removed dressing provided with a layer of soft adhesive means that such a dressing can be reapplied with substantially unchanged adhesion.

A weakness of self-adhesive articles attached to the skin by skin-friendly soft adhesives is that, although they have good adhesion at short-term loads, they often have insufficient adhesion at long-term loads, even low loads. For example, in articles where the attachment is loaded by the gravity of the attached article, e.g. ostomy bags or surgical drapes, it has been found that the attachment after a time, which may be less than an hour, loosens due to a slow creeping pull-off. 10 15 20 25 530 09? The present invention aims at eliminating this weakness of articles adhering to skin by means of self-adhesive soft adhesives.

SUMMARY OF THE INVENTION This object is achieved by means of a component for applying a medical device to a skin or to a medical article intended to be attached to the skin, which component comprises a layer of carrier material, which on its underside, i.e. the side which, when using the medical device, is directed towards the skin, is coated with a layer of adhesive, characterized in that the component on its upper side has a framing area for the article or elements of the article, which attachment area is located at a distance of at least 5 mm from at least two opposite edges of the component, in which the adhesive consists of a skin-friendly, soft self-adhesive adhesive, which in the test of creeping peeling has a peeling rate greater than 0.05 ml / min at a load of 0.2 N / 25 mm, and at which the fastening groove is located at a distance of at least 5 mm from at least the opposite edges of the component, which are loaded by tensile and / or shear forces when using the article.

According to a preferred embodiment, the adhesive in the creep stripping test has a stripping speed greater than 0.5 mn / min at a load of 0.4 N / 25 mm.

Furthermore, the adhesive advantageously consists of a skin-friendly, soft self-adhesive adhesive, which has an adhesion to skin of 0.2 ~ 4 N / 25 mm and a softness of 10-22 mm. The carrier layer is preferably made of a plastic film, advantageously a polyurethane film with a thickness of 10-50 micrometers. 10 15 20 25 530 D97 In a variant of the invention, an operating sheet or operating cloth is attached to the component.

In another variant, the component is a component of a stornifórbaiid.

In a third variant, the component comprises a means for attaching a hose or other medical devices to its upper side. The fastening member can consist of male or female parts of a mechanical fastening element.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will now be described with reference to the accompanying drawings, of which; fi g. 1 schematically shows a sectional view of attachment of a surgical drape to a patient according to the prior art, fi g. 2 schematically shows a sectional view of a fastening of a surgical drape on a patient according to an embodiment of the invention, fi g. Fig. 3 schematically shows a part of the view in Fig. 2 on a larger scale, Fig. 4 schematically shows a plan view of an annular component for attaching a medical device to the skin of a user, fi g. 5 schematically shows a plan view of a component for attaching a tubing or a surgical element to the skin of a patient, fi g. 6 schematically shows a section through the line VI-VI in figure 5, 10 15 20 25 530 09? fi g. 7 schematically illustrates a method of measuring adhesive force against skin, fi g. 8 and 9 schematically illustrate a method of measuring softness, fi g. 10 and 11 schematically illustrate a method of measuring creep stripping of adhesive, fi g. 12 shows a diagram of adhesive creeping stripping for various adhesives, and fi g. 13 and 14 illustrate a measurement of adhesive creep stripping with a load distribution in accordance with the present invention.

DESCRIPTION OF EMBODIMENTS Figure 1 shows a prior art operating sheet A applied to a patient P lying on an operating table T. This sheet has an adhesive coating B along its upper edge, which attaches the sheet to the patient. This attachment is continuously loaded for the weight of the sheet and is dimensioned to absorb this load, which normally increases with time due to the sheet absorbing liquid either by absorption or by liquid collection bags or the like arranged at the bottom edge of the sheet. Recently, the use of soft skin-friendly adhesives has been proposed for the coating B, partly because these do not carry skin cells during removal, and partly because they offer an opportunity with extremely good sealing against the skin. However, it has been found that there is a risk that sheets with soft skin-friendly adhesives have a tendency to come loose during a prolonged load due to slow creeping peeling. 10 15 20 25 530 09? When the adhesive coating B of the sheet A in Figure 1 is exposed to the weight of the sheet, the forces between skin and adhesive are concentrated to the edge C of the contact surface of the adhesive coating B. Although the tensile force from the sheet A is for the most part distributed as shear force in the adhesive coating B, even relatively small fl elderly fi will appear. There is then a risk that the load locally becomes higher than the adhesive force of the adhesive and that the connection between skin and adhesive comes loose at the edge C, which means that the load forces are moved a bit in from the edge. This process then continues so that the sheet comes loose through a slow step-by-step pull-off.

It will be appreciated that the above-mentioned sensitivity to loads concentrated against an edge of the contact surface between skin and adhesive for soft skin-friendly adhesives also applies to articles other than surgical drapes and of course also for short-term loads concentrated to an edge of the contact surface.

Corresponding stripping processes can take place at other edges depending on other loads that arise during the use of the sheet, lifting forces can also occur.

The present invention is primarily intended to solve the problem of the above-mentioned creeping deduction.

By soft skin-friendly adhesives, as approached above, can follow the contour of the skin extremely well arises in addition to a large contact surface compared to hard adhesives a negative pressure effect, which increases the adhesion of the dressing to the skin. This effect arises during application in that all the air below the contact surface can be forced out when applying an article provided with such an adhesive coating against the skin. The contact surface can be compared to 10 15 20 25 530 037 mechanical suction plugs, which are entirely based on the principle of creating negative pressure under load. This effect is best ensured if the adhesive coating is of such a type that it also seals against so-called micro-leakage, ie prevents air from penetrating below the contact surface between the adhesive and the skin through folds or cracks in the skin.

Figures 2 and 3 (larger scale) schematically show an embodiment of an operating sheet 1 provided with a component 2 according to the invention.

Component 2 consists of a carrier 4, coated with a layer of soft skin-friendly adhesive 3. The edge of the sheet 1 is attached to the carrier 4 by a narrow adhesive joint 5, which extends centrally on the upper side of component 2 at a distance from those in Figures 2 and 3 the left and right edges of the component 2. The joint 5 can be constituted by any suitable adhesive, e.g. an acrylate adhesive. It is of course also possible to attach the edge of the sheet 1 to the carrier 4 by means of other types of joints, for example a welding joint.

The load of the sheet 1 will be concentrated to the center of the component 2, which extends along the edge of the sheet. The load will then be distributed over an area below the joint 5 and will decrease in the direction of the left and right edges of Figures 2 and 3. This means that the shear and shear forces at the edges are less than if the sheet were attached to the entire upper side of component 2, as in the prior art shown in Figure 1. This reduces the risk of the sheet coming loose by the above-mentioned creeping peeling, which starts from one of the edges of the attachment. This placement of the sheet attachment to component 2 also increases the resistance of this component to high short-term loads, e.g. in the normal direction of the skin. Such loads may lift central parts of component 2 from the skin but since 10 15 20 25 530 09? no air penetrates through the edges, the formed negative pressure will, as soon as the load ceases, suck again these central parts against the skin.

Since the soft, skin-friendly adhesive does not carry skin cells when lifting the central parts from the skin, the component will show approximately as high adhesion to the skin after being sucked in by the negative pressure as after a first application. Although in many cases it may be sufficient for the component 2 to end at the side edges of the sheet 1, i.e. the edges which lie in planes parallel to the plane of the paper in the grooves 2 and 3, it is suitable to allow the component 2 to extend past these edges. This reduces the risk of the side edges of the component coming loose during short-term or long-term loading of the side edges of the sheet. In other types of medical devices where prolonged loads can load fl your edges, it is necessary that the attachment of the medical article on the top of the component is located at a distance from all its edges. The distance from exposed edges should be 5 mm, preferably 10 mm, preferably 15 mm or more.

In order for component 2 to function as intended, it is important that the carrier 2 is not so rigid that it transfers the central load directly to the edges of the component, but the forces must be conducted in and distributed in the underlying adhesive layer. Thereby, the forces are concentrated to the central part of the adhesive coating and decrease in the direction of the edges, which considerably reduces the risk of component 2 coming loose. In order for this desired force absorption to take place in the adhesive coating, the carrier 2 must be flexible, stretchable and also advantageously so elastic that it regains original configuration after stretching. These properties of the wearer also mean that component 2 as a whole can easily follow the imperfections of the skin and thus avoid air bubbles forming between adhesive and skin after application of the component. The carrier can consist of a plastic film, e.g. a polyurethane film with a thickness of 10-50 micrometers.

Other useful plastic materials are polyester and polyethylene. Preferably, the thickness of the plastic is less than 50 micrometers, more preferably 10 to 30 micrometers.

Suitable soft, skin-friendly adhesives suitable for use according to the invention may be, for example, an addition-curing RTV (Room Temperature Vulcanizing) silicone system, which after mixing crosslinks and forms a self-adhesive elastomer. Examples of RTV addition-curing silicone systems are given in EP 0 300 620 A1 where the so-called "Gel-forming compositions" consisting of an alkenyl-substituted polydiorganosiloxane, an organosiloxane containing hydrogen atoms bonded to a part of the silicone atoms and a platinum catalyst are described.

Wacker SilGel 612 is a commercially available RTV silicone system.

This is a two-component system. By varying the proportions between the two components A: B from 1,020.7 to 1.0: 1.3, one can vary the softness and the level of adhesion of the formed elastomer.

Examples of additional soft silicone elastomers that adhere to dry skin are NuSil MED-6340, NuSil MED3-6300, NuSil MED12-630O from NuSil Technology, Carpintieria, GA, USA and Dow Coming 7-9800 from Dow Coming Corporatiion, Midland, USA. Other soft skin-friendly adhesives may also be considered for the present invention, for example hot melt adhesive Dispomelt® 70-4647 from National Starch and Chemical Company, Bridgewater, NJ, USA. 10 15 20 25 530 097 10 Component 2 works best if the adhesive coating also seals against micro-leakage, ie prevents air from penetrating under the adhesive coating via skin cracks, skin folds or other irregularities in the skin. Such leakage of air can give rise to reduction or even elimination of the above-mentioned negative pressure effect of an applied component. It has surprisingly been found that for a skin-friendly adhesive, the above-mentioned leakage risk can be eliminated or at least significantly reduced if the adhesive is sufficiently soft and has a sufficiently high basis weight. The adhesive coating 3 should therefore have a softness of 10-22 mm and a basis weight of 50 g / m 2 or more.

Preferably, the adhesive coating should be leak-proof according to the MHC Leak Test with a groove depth of 75 micrometers. MHC Leak Test is described in detail in patent application SE 0500061-7, to which reference is made for further details.

Of course, since the properties of the skin vary from person to person, the adhesion resistance of the adhesive coating to skin also varies for different patients. The adhesive force also depends on the thickness of the soft adhesive and the mechanical properties of the carrier layer. The standard methods for measuring adhesion that are currently used use plates of various kinds, e.g. of steel or glass, and does not provide values relevant for measuring skin adhesion. The values of adhesion to skin of an adhesive stated shall be measured by a method schematically illustrated in Figure 7 and developed by the applicant.

Strips of a self-adhesive component, the adhesion of which to the skin is to be measured, are punched out to a size of 25 x 125 mm. It should be noted that all strips are also provided with a carrier layer on the back of the adhesive bandage. 10 15 20 25 530 05? ll (This carrier layer has the function of stiffening the strips when applied to the skin.) Then the strips are placed on the skin on the back of healthy volunteers. Gently iron the strips with a finger and then remove the carrier layer on the back of the strips. Finally, the strips are pressed against the skin for 3 seconds using a foam sponge (42 x 182 mm, thickness = 48 mm) glued to a steel plate (50 x 200 mm, thickness = 1 mm). The compressive force is estimated at 6 kN / mz.

The strips are allowed to sit on the skin for 2 minutes. Then the strips are pulled off at a speed of 25 mm / sec and the peeling force F1 is measured.

The subtraction angle, ie. the obtuse angle formed between the skin surface and the peeled off part of the strip shall be 135 °. The adhesive force of the strip against the skin is the average force of the force F1.

Adhesives useful in components according to the invention must have an adhesive force according to this method of at least O.2-4 N / 25mm.

Preferably the adhesive force is 1-2.5 N / 25mm.

Adhesives according to the present invention shall have a softness exceeding 10 mm measured by a method based on ASTM D 937 and ASTM D 51580. Some deviations, which are shown below, have been made. Figures 8 and 9 illustrate this modified method of measuring the softness of an adhesive by allowing a cone B weighing 62.5 g by gravity to penetrate into a 30 mm thick specimen C of the adhesive, the softness of which is to be determined. The test specimen is obtained by filling a cylindrical glass container with an inner diameter of 60 mm, an inner height of 35-40 mm with adhesive up to 30 mm high. For a silicone elastomer, uncured silicone prepolymer is filled into the container and then crosslinked to an elastomer in the glass cylinder. The cone used is shown in Figure 8 and has the following dimensions; a = 65 mm, b = 30 mm, c = 15 mm and d = 8.5 mm. In performing the softness measurement method, the cone B is first lowered to a position I, which is shown by dashed lines in Figure 9 and in which the tip of the cone just touches the surface of the specimen C. Thereafter, the cone B is released so that it is gravity is allowed to penetrate into the specimen C. The number of mm of the tip of the cone B has penetrated into the specimen C after 5 seconds is measured and constitutes the penetration value P, which becomes larger the softer the specimen body The penetration value P is the softness measure used in the present invention. In performing the method, a Penetrometer PNR 10 from Sommer & Runge KG, Germany was used.

The applicant has developed a test method for measuring the creeping peel of adhesives. Note that this method of determining the creep properties of an adhesive only applies to specimens whose surface is completely coated with adhesive.

Samples P of size 25 * 105 mm are punched out of materials coated with the adhesive to be tested.

A scratch-free steel plate S (according to ASTM A 666-94 A, 50 x 200 mm) is washed three times with a lint-free absorbent material soaked with n-heptane.

Finally, a final wash is performed with acetone instead of n-heptane.

The steel plate is then allowed to dry for at least 10 minutes, but not longer than 10 hours.

The test piece P is reinforced at one end by means of a strong tape T. A 4 cm long piece of this tape is weighed, which piece of tape is then to be fastened twice over the end of the test piece, as schematically shown in Figure 10. For a test piece P of adhesive coated film, this is laid far forward on the plate with the adhesive directed towards the steel plate, after which the tape is folded over one edge of the sample and the pre-stiffening layer, which facilitates application of the film, is carefully pulled off. A hole is made in the tape and through the end of the test piece so that a weight W can hang freely. It is important that the test piece is placed against the steel plate carefully so that no pressure is applied to the test piece. For test pieces without stiffening layer to be removed, the tape can be attached to the end of the test piece before the test piece is attached to the steel plate.

Then a piece of polyurethane foam (L00562-6, 1.6 mm from Rynel Inc., Boothbay, ME, USA) is placed over the specimen on the steel plate, and the specimen is firmly attached to the plate by a defect (45 mm wide, weight = 2040g, r = 47mm) rolled back and forth on top of the foam piece once, at a speed of 5 mr / second. The sample is then allowed to rest for 1 hour.

After 1 hour has elapsed, a weight Wi is attached to the tape-containing end of the test piece P and the end is unfolded so that the weight hangs straight down as shown in Figure 11 and the zero position is marked on the steel plate. The zero position is placed 2.5 cm from the end of the piece of tape, so that 8 cm of the test piece is attached to the steel plate and 2.5 cm hangs down with weight on, as shown in figure 11.

Timing begins and depending on the weight and type of adhesive, the time intervals are varied and marked on the steel plate. The markings are then recalculated to the stripping speed of the test piece in number of mm / min.

Products and materials tested using the above method Polyurethane fi lm 20 μm coated with silicone gel (Silgel 612 from Wacker Chemie GmbH Germany) with a softness of 15 mm and basis weight 60 g / mz Polyurethane fi lm 20 μm coated with silicone gel (Silgel 612 from Wacker Chemie GmbH Germany) with softness of 15 mm and basis weight 100 g / mz 10 15 530 09? 14 Polyurethane fi lm 20 μm coated with silicone gel (Silgel 612 from Wacker Chemie GmbH Germany,) with softness of 15 mm and basis weight 500 g / mz Klinidrape® from Mölnlycke Health Care AB, Sweden (test pieces have been taken from the product's adhesive edges) T egaderrnm from 3M Health Care, USA Opsite Flexigridl ”from from Smith & Nephew Medical Limited, England Me fi lmm from Mölnlycke Health Care AB, Sweden The above products were tested with different weights corresponding to the forces 0.05, 0.1, 0.2, 0.5, 1 and 2.5 N / 25 mm.

The results of these tests are shown in Figure 12 and in Table 1 below.

Table 1: Pulling speed 90 degrees from steel.

Material Force Force Force Force Force Force Force NI25mm NI25mm N / 25mm NI25mm NI25mm NI25mm 0.05 0.1 0.2 0.5 1 2.5 Speed Speed Speed Speed Speed mm / min mm / min mm / min mm / min mm / min mm / min SiIiGel 60glm2 0.17 1.87 28 1000 1000 1000 SiIGeI 100glm2 0 0.1 0.22 4.8 30.2 1000 SiIGeI 500glm2 O 0.13 0.75 8.9 87 1000 Klinidrape 0 0 O 0.05 0.11 0.79 Tegaderm O 0 O 0 0.98 1000 Opsite F Iexig rid 0 0 O 0 0 0.17 Mefllm 0 0 0 0 0.15 0.62 In the test performed, the adhesive is thus exposed for a local line e load.

The results of the tests can thus be said to constitute a measure indicating the local adhesion of the tested adhesive. As can be seen from the test, the soft and skin-friendly adhesives, which according to the invention are suitable for adhering to skin, release from the substrate at relatively low, long-term loads of 10 15 20 25 530 09? 0.05 - 0.2 N / 25mm while the adhesives of the other tested products remained attached to the substrate. This confirms the thesis that it is the low local adhesion to skin of soft, skin-friendly adhesives that greatly contributes to the skin-friendliness and other good properties of such adhesives. The test performed can be said to be a kind of measurement of the local adhesion of an adhesive.

In order for an adhesive to be considered soft and skin-friendly according to the present invention, they should be on the left, see arrow A, if the line drawn in Figure 12 between two crosses. Thus, the stripping speed must be greater than 0.05 mn / min at a load of 0.2 N / 25mm and greater than 0.5 mm / min at a load of 0.4 N / 25mm.

To ascertain the effects of the present invention, the following tests were performed.

A scratch-free steel plate S (according to ASTM A 666-94 A, 50 x 200 mm) is washed with a lint-free absorbent material soaked with n-heptane three times.

Finally, perform a final wash with acetone instead of n-heptane.

The steel plate is then allowed to dry for at least 10 minutes, but not longer than 10 hours.

Sample pieces P of the same test material as above of size 25 * 105 mm were attached with the self-adhesive glue to the steel plate in the same way as previously described.

Attached to one end of the sample P is a double-sided adhesive pad F consisting of approximately 1 mm thick foam with a size of lx x 15 mm, so that three of the four edges of the adhesive pad F lie four mm inside the edges of the sample piece. The position on the corner of the test piece is marked with a felt-tip pen on the steel plate S so that any peeling of the test piece from the steel plate and / or the lateral displacement of the test piece can be read with an accuracy of 0.5 mm.

The test is schematically illustrated in Figures 13 and 14.

Attach to the fastening pad F a strip of paper PS which is loaded with the same weights as in the test described according to Table 1. The distance for which the corner of the test piece is vid when loaded for 30 minutes is read. The result was that neither peeling nor side-splitting took place, neither for the specimens coated with SilGel 612 nor for the other specimens. A marked improvement in the resistance force against prolonged creeping load of the test pieces coated with SilGel 612 could thus be observed.

Figure 4 shows a plan view of a component 6 included in an ostomy dressing.

The component 6 comprises a circular carrier 7 with a hole 8 in the middle for performing a stoma. On its underside, i.e. the side which, when the component is used, faces the skin of a user, the carrier 7 is provided with a coating of a soft and skin-friendly adhesive.

On the upper side of the carrier 7, the component 6 has an annular attachment area 9, which is marked with dashed lines in the figure, for the ostomy bag itself (not shown in the figure). The attachment of the bag can consist of an adhesive liner, which facilitates the change of bag, but can also consist of a fixed attachment in the form of a heat weld joint. In order to avoid even in this case a concentration of force at the outer or inner edge of the component, the fastening area must be located at a distance from both of these edges at a distance of at least 5 mm. In the case of such a component, the adhesive coating must not only prevent leakage but also that liquid from the stoma can pass out to the skin surrounding the component 6.

It is therefore very advantageous if the adhesive coating has such a combination of softness and basis weight that it also seals against micro-leakage to ensure this function. The carrier materials and adhesives which are suitable for the component 2 shown in Figures 2 and 3 are also suitable in this application of the invention.

It is pointed out that the term that the attachment area is located "at a distance from at least two opposite edges of the component" is also applicable to components of round or oval shape, in which one half of the contour forms an edge and the other half an opposite edge.

Figures 5 and 6 show a third embodiment of the invention consisting of a component 10. This component has a carrier 11, to the upper side of which a fastening element 12 for a hose or a surgical instrument is attached, preferably by means of an adhesive bandage. The fastening element 12 comprises a lower part 13, which on its underside is attached to the upper side of the carrier 11, and an upper part 15, which can be folded over the lower part 13, e.g. through a hinge joint 14. The upper part 15 has hook means 16,17 on the side facing the lower part in the folded position of the upper part and the lower part has on its upper side loop means 18, which can cooperate with the hook means 16,17 for releasably lock the lower and upper parts against each other.

Of course, the loop means could be arranged on the upper part and the hook means on the lower part instead.

The upper and lower parts 13,15 may consist of a plastic material, a nonwoven (NW) or a textile material or a laminate of plastic and NW or plastic and textile material. In cases where NW or textile material is included or constitutes the upper and lower parts, no separate loop means are needed, but hook means that can cooperate with these materials can be used.

The carrier 11 has on its underside an adhesive coating 19 which is covered by release paper 20, which provides protection for the adhesive coating for the surface. 18 use and which is removed before application of the component. The carrier materials and adhesives suitable for the component 2 shown in Figures 2 and 3 are also suitable in this application of the invention. Also in this embodiment, the attached lower part 13 of the fastening element 12 must be located at a distance from the edges of the component 10 of at least 5 mm.

Furthermore, the components 2 and 6 according to the embodiments are described with reference to Figures 2-4, suitably provided release paper or similar protective layers.

The invention is intended to be applied to all components for fixing a medical device to the skin or included in a medical article intended to be attached to the skin, which on its upper side carries or comprises elements for supporting a load and shall not be limited to the above-mentioned embodiments. .

The materials included in the components according to the invention are sterilizable.

The described embodiments can of course be modified within the scope of the invention. For example, the component shown in Figure 4 need not be circular but may be, for example, rectangular, square, octagonal, etc., and the component shown in Figures 5 and 6 need not be rectangular but may be circular. Furthermore, the fastening element on the upper side of the one shown in Figures 5 and 6 can be designed in a different way, for example both hook and loop members could extend over the entire surface of the upper and lower part, respectively. Fasteners other than hook and loop members could be used, e.g. glue or push buttons. In addition, it may be advantageous that at least the upper part is made of an elastic material. The invention should therefore be limited only by the content of the appended claims.

Claims (2)

1. 0 15 20 25 530 09? 3.0 Patent claims. Component (2) for applying a medical device to the skin or contained in a medical article (1) intended to be attached to the skin, which component comprises a layer of carrier material (4), which on its underside, i.e. the side which, when using the medical device, is directed towards the skin, is coated with a layer of adhesive (3), characterized in that the component (2) has on its upper side an attachment surface area (5) for the article or elements of the article, which attachment area is located at a distance of at least 5 mm from at least two opposite edges of the component, in which the adhesive (3) consists of a skin-friendly, soft self-adhesive adhesive, which in the test of creeping peeling has a peeling speed greater than 0.05 mm / min at a load of 0. N / 25 mm, and at which the mounting bracket (5) is located at a distance of at least 5 mm from at least the opposite edges of the component (2), which are loaded by tensile and / or shear forces when using the article. . Component according to claim 1, in which the adhesive 3 in the creep stripping test has a stripping speed greater than 0.5 mm / min at a load of 0.4 N / 25 mm. . Component according to Claim 1 or 2, in which the adhesive (3) has a skin adhesion of 0.2 to 4 N / 25 mm, a softness of 10 to 22 mm and a basis weight of at least 50 g / m 2. . Component according to Claim 1, 2 or 3, in which the carrier layer (4) consists of a plastic fi ch. 10 15 530 09? 21. Component according to Claim 4, in which the plastic film (4) consists of a polyurethane film with a thickness of 10 to 50 micrometers. . Component (2) according to any one of claims 1-5, to which an operating sheet (1) or an operating cloth is attached to the component. . Component (6) according to any one of claims 1-5, which is included as a component (6) in an ostomy bandage. . Component (10) according to any one of claims 1 ~ 5, which comprises a means (12) for attaching a hose or other medical articles to the upper side of the component (10). . Component according to claim 8, in which the fastening means consists of male or female parts of a mechanical fastening element.