An ostomy sealing device

Abstract

The present invention relates to an adhesive element for an ostomy device, a base plate for an ostomy device comprising the adhesive element, and an ostomy appliance, said ostomy appliance comprising the adhesive element. The adhesive element is constituted by a plurality of rings or ring segment, arranged concentrically around the center of the adhesive element towards the outer edge of the adhesive element. At least a first ring or ring segment, being located at the center of the adhesive element, can be separated from the remaining rings or ring segments of the adhesive element.

Description

[0001] AN OSTOMY SEALING DEVICE

[0002] TECHNICAL FIELD

[0003] The present invention relates to an adhesive element for an ostomy device, a base plate for an ostomy device comprising the adhesive element, and an ostomy appliance, said ostomy appliance comprising the adhesive element.

[0004] SUMMARY

[0005] One aspect of the disclosure provides an adhesive element in accordance with claim 1, a base plate according to claim 1, a base plate for an ostomy device according to claim 34, and an ostomy appliance according to claim 35.

[0006] WO 2023 / 208303 describes a composition for sealing around a stoma. WO2018 / 054442 describes an adhesive ostomy element.

[0007] BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The accompanying drawings are included to provide a further understanding of embodiments and are incorporated into and a part of this specification. The drawings illustrate embodiments and, together with the description, serve to explain principles of embodiments. Other embodiments and many of the intended advantages of embodiments will be readily appreciated, as they become better understood by reference to the following detailed description. The elements of the drawings are not necessarily to scale relative to each other. Like reference numerals designate corresponding similar parts.

[0009] Figure 1 shows a cutaway perspective image of an adhesive element.

[0010] Figure 2 shows cutaway perspective image of a further adhesive element.

[0011] Figure 3 shows cutaway perspective image of a further adhesive element.

[0012] Figure 4 is a cross-sectional image of an adhesive element, when in place around a stoma.

[0013] Figure 5 is a cross-sectional image of an adhesive element, when in place around a stoma. Figure 6 is a cross-sectional image of an adhesive element, when in place around a stoma.

[0014] Figure 7 is a plan view of an adhesive element.

[0015] Figures 8A and 8B show a further embodiment of an adhesive element.

[0016] DETAILED DESCRIPTION

[0017] In the following, whenever referring to the proximal side of a device or part of a device, the referral is to the skin-facing side, when the wafer or ostomy appliance is worn by a user.

[0018] Likewise, whenever referring to the distal side of a device or part of a device, the referral is to the side facing away from the skin, when the wafer or ostomy appliance is worn by a user. In other words, the proximal side is the side closest to the user, when the wafer is fitted on a user and the distal side is the opposite side - the side furthest away from the user during use.

[0019] An axial direction is defined as the direction of the stoma, when the appliance is worn by a user. Thus, the axial direction is substantially perpendicular to a skin surface of a user, such as an abdominal skin surface. A radial direction is defined as transverse to the axial direction.

[0020] In the following, the words "ostomy" and "stoma" are used interchangeably without any intention to have different meanings.

[0021] By output is herein meant the effluent from a stoma, being faeces and / or urine in a more or less viscous form or mucins secreted from the epithelial layer of the alimentary canal. In the case of a colostomy, the output may be quite solid, whereas an ileostomy may produce more liquid output. The output may contain digestive fluids with enzymes and other components that may be aggressive to the skin and thus may cause maceration and contact dermatitis of the skin if brought into contact with it as well as the output may comprise components that may attack and degrade the adhesive.

[0022] The term "water-swellable" refers to a layer which is able to expand upon contact with fluids e.g. water-containing fluids such as ostomy output. Swelling is caused by water physically entering the layer and causing an increase in volume. The speed of water-swelling is determined by the swelling speed test method described herein. An adhesive element for an ostomy device is thus provided, said adhesive element comprising: a first adhesive composition, and a second water-swellable composition, wherein the adhesive element is delimited by an outer edge and has a center portion, wherein at least the second composition extends to the center portion of the adhesive element, wherein said adhesive element has at least one adhesive surface.

[0023] The adhesive element is constituted by a plurality of rings or ring segments, arranged concentrically around the center of the adhesive element towards the outer edge of the adhesive element, whereby at least a first ring or ring segment, being located at the center portion of the adhesive element, can be separated from the remaining rings or ring segments of the adhesive element.

[0024] Suitably, the adhesive element consists of the first adhesive composition, and the second water-swellable composition.

[0025] An adhesive element acts to adhere an ostomy appliance, or a component of an ostomy appliance, to the skin of a wearer. The adhesive element may be a part of an ostomy appliance comprising a collecting bag. The collecting bag may be detachably or permanently attached to the adhesive element e.g. along a connection zone circumferencing the bag inlet.

[0026] When fitting an adhesive element to the area around a stoma, there will be a peristomal gap between the edge of the hole in the adhesive element and the stoma itself. Output which flows into the peristomal gap may lead to maceration of the skin and degradation of the adhesive, resulting in leakage, unintended detachment of the adhesive element and discomfort to the user.

[0027] The second, water-swellable composition in the adhesive element can swell rapidly, helping to seal the peristomal gap within a short time period (e.g. 2-30 minutes). The first adhesive composition may swell more slowly, which also helps to seal the peristomal gap in a secure manner.

[0028] The adhesive element is delimited by an outer inner edge and is preferably ring-shaped and delimited by an inner edge. By "ring-shaped" is meant that the adhesive element has outer and inner edges in the radial direction, each of which is substantially circular or oval. Suitably, the adhesive element comprises opposing distal and proximal surfaces and a through-hole from said distal surface to said proximal surface for accommodating a stoma. Additional film layers may be included within the adhesive element, and / or on the distal or proximal surfaces thereof.

[0029] The adhesive element has at least one adhesive surface. The adhesive surface of the adhesive element may be provided by the first adhesive composition. In particular, the adhesive surface of the adhesive element may be located on the proximal side of the adhesive element.

[0030] Suitably, the inner edge of the adhesive element defines a through-going hole in said adhesive element, for accommodating a stoma. At least the second composition extends to the inner edge of the adhesive element, about at least a portion of the circumference of the through-going passage. Suitably, the inner edge of the adhesive element, about the circumference of the through-going passage, is constituted by the second composition; i.e. the entirety of the inner edge of the adhesive element is formed by the second composition.

[0031] Other components of the adhesive element may also extend to the inner edge of the adhesive element, as set out below. For instance, the first composition may also extend to the inner edge of the adhesive element, about the circumference of the through-going passage.

[0032] When the adhesive element is exposed to moisture, the second composition suitably has a swelling rate, when measured as according to the swelling speed test method described in the specification, which is higher than said first composition.

[0033] The adhesive element is constituted by a plurality of rings or ring segments, arranged concentrically around the center portion of the adhesive element towards the outer edge of the adhesive element. At least a first ring or ring segment, being located at the center portion of the adhesive element, can be separated from the remaining rings or ring segments of the adhesive element.

[0034] Preferably, the adhesive element is constituted by a plurality of rings or ring segments, arranged concentrically around the through-going passage from the inner edge of the adhesive element towards the outer edge of the adhesive element. At least a first ring or ring segment, being located at the inner edge of the adhesive element, can be separated from the remaining rings or ring segments of the adhesive element. This can provide a through- passage, or an enlarged through-passage, in said adhesive element. In this manner, the through-going passage in the adhesive element can readily be adjusted to provide improved fit to a stoma.

[0035] The term "concentric" or "concentrically" is used to mean that the rings / ring segments are arranged adjacent one another the radial direction of the adhesive element.

[0036] The through-going passage in the adhesive element is suitably circular, or oval-shaped. An oval through-going passage allows a fit to a range of stoma shapes, while the swelling of the second composition allows the peristomal area to be filled.

[0037] The adhesive element is constituted by a plurality of rings or ring segments, i.e. two or more rings or ring segments. Suitably, the adhesive element comprises three or more, such as four or more, five or more, six or more, or seven or more rings or ring segments.

[0038] First adhesive composition

[0039] The adhesive element comprises a first adhesive composition. The first adhesive composition is a skin-adhesive, meaning that it can adhere sufficiently to skin while in use, but can relatively easily be removed, with minimal pain to the user or damage to the skin

[0040] The first adhesive composition acts to adhere the adhesive wafer to the skin of the user. Preferably the adhesive composition is a water-swellable composition. It suitably comprises a polymer comprising monomer units selected from the group consisting of styrene, isoprene, butadiene, ethylene, and butylene. In embodiments, the skin-adhesive composition comprises a styrene block co-polymer. In embodiments, the skin-adhesive composition comprises a styrene block co-polymer selected from the group consisting of styrene- isoprene-styrene (SIS), styrene-butadiene- styrene (SBS), styrene-isobutylene-styrene (SIBS), and styrene-ethylene / butylene-styrene (SEBS). In embodiments, the adhesive composition comprises a polyethylene copolymer.

[0041] In embodiments, the adhesive composition comprises a polyethylene copolymer selected from the group consisting of ethylene vinyl acetate, ethylene vinyl acetate carbon monoxide, ethylene butyl acetate, ethylene vinyl alcohol, ethylene butyl acrylate, ethylene butyl acrylate carbon monoxide, and combinations thereof. In embodiments, the adhesive composition comprises polyisobutylene (PIB).

[0042] In embodiments, the adhesive composition comprises absorbent material selected from the group consisting of hydrocolloids, microcolloids, salt, and super absorbent particles. In embodiments, the adhesive composition comprises an absorbent material in an amount of 1-60% (w / w) of the layer. For instance, the layer comprises an absorbent material in an amount of 1-40% (w / w) or 1-20% (w / w) or 20-40% (w / w) or 20-60% (w / w) or 40-60% (w / w) or 25- 50% (w / w) of the composition. In embodiments, the absorbent material is selected from hydrocolloid, water soluble salt, mono, di- and oligosaccharides. In embodiments, the hydrocolloid is selected from guar gum, locust bean gum, pectin, potato starch, alginates, gelatine, xantan or gum karaya, cellulose derivatives, salts of carboxymethyl cellulose, sodium carboxymethyl cellulose, methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, sodium starch glycolate, polyvinylalcohol, and mixtures thereof.

[0043] Second water-swellable composition

[0044] The adhesive element comprises a second water-swellable composition. Suitably, the water- swellable composition can expand more rapidly than the first adhesive composition and provide a seal about the stoma. The water-swellable composition is substantially nonadhesive. By non-adhesive is meant that it cannot support its own weight when adhered to a vertical surface. Suitably, the second composition is a gel-forming composition. In one aspect the second composition disintegrates upon exposure to moisture.

[0045] The water-swellable composition typically comprises a clay, such as a smectite clay, preferably bentonite or laponite, more preferably laponite. The clay acts to absorb water, and thus expand the gel-forming layer.

[0046] The water-swellable composition suitably comprises a matrix material, in which said clay is dispersed. The matrix material may be a polymer matrix. Suitable polymer matrixes include polypropylene (PP), polybutene (PB) or blends thereof. Additional components of the matrix material include hydrophilic polymers, e.g. polyethylene glycol (PEG), polyvinyl alcohol (PVA), polyvinyl pyrrolidone (PVP) and ethylene vinyl acetate (EVA), and hydrocolloids such as starch, CMC or gelatine.

[0047] The water-swellable composition may - alternatively or additionally - comprise superabsorbent material, e.g. superabsorbent polymer (SAP). Known superabsorbent polymers include polymers and co-polymers of acrylic acid, acrylic acid esters (e.g. methyl acrylate) and acrylic acid salts.

[0048] In one aspect, water-swellable composition may comprise or consist of a mat (i.e. a nonwoven layer) of superabsorbent fibres (SAF). Such a layer may be made by airlaying or needling fibres of superabsorbent material to form said nonwoven layer. The use of a nonwoven layer can be beneficial, as it provides good flexibility, while maintaining good liquid absorption. Suitably, the mat of SAF has a thickness of at least 1mm, such that it provides a cushioning effect and presses the proximal surface of the adhesive wafer towards the skin.

[0049] Layered adhesive element

[0050] The adhesive element suitably comprises a first layer and a second layer, wherein said first adhesive layer consists of said first adhesive composition and the second layer consists of said second, water-swellable composition.

[0051] The second layer suitably has a thickness of between 0.1 and 3mm. The second layer suitably has an extension radially from the through-hole of between 10 and 50mm.

[0052] The dimension of the first layer in a direction away from the stomal through-hole may be greater than the dimension of the second layer in said direction. This provides that the first adhesive layer can be exposed on both proximal and distal surfaces of the adhesive wafer.

[0053] According to this embodiment, the adhesive element suitably further comprises a third adhesive layer, wherein the second layer is arranged between the third layer and the first layer. The third adhesive layer may comprise the same materials as the first adhesive layer.

[0054] The various layers of the adhesive element according to this aspect may have different properties, e.g. wherein the adhesive composition of the first layer is an elastic adhesive and wherein the adhesive composition of the third layer is a plastic adhesive. This allows a user to choose the arrangement of adhesives which is best suited to their needs.

[0055] Suitably, the adhesive element further comprises at least one film layer, suitably wherein at least one film layer is arranged on an external surface of the adhesive element.

[0056] In one particular aspect, the adhesive element comprises a first layer and a second layer, wherein said first adhesive layer consists of said first adhesive composition and the second layer consists of said second water-swellable composition, wherein at least one film layer is arranged between said first and second layers. Incorporation of a film layer in this manner would allow the first and second layers to move independently of each other.

[0057] In one aspect, the adhesive element comprises a first layer and a second layer, wherein said first layer consists of said first adhesive composition and the second layer consists of said second, water-swellable composition, wherein said first layer comprises a first primary face and said second layer comprises a second primary face, preferably wherein the first and second layers are arranged such that the first primary face of the first layer and the second primary face of the second layer are arranged in contact with each other in said adhesive element.

[0058] According to one aspect, the film layer is plastically deformable. This means that it will not return to its original shape after being deformed. This - in turn - allows an adhesive element to be moulded to fit around a stoma. The adhesive element can be manufactured to be larger than most stomas, in which case it will be deformed towards the stoma after application to the user's skin. Alternative, the adhesive element can be manufactured to be smaller than most stomas, in which case it can be deformed away from the stoma before application to the user's skin. Parafilm is an example of a plastically deformable film layer.

[0059] According to another aspect, the film layer is elastically deformable. This means that it will return to its original shape after being deformed. This - in turn - allows an adhesive element to be expanded over a stoma, and then reduce in size.

[0060] A particular adhesive element has a laminate construction with the following arrangement of layers, in order: an adhesive layer, a layer of said second, water-swellable composition, a film layer, a superabsorbent fiber layer a topfilm layer.

[0061] The film layer may suitably be constituted by a plurality of film layer rings, arranged concentrically around the through-going passage from the inner edge of the adhesive element towards the outer edge of the adhesive element, wherein each ring of the adhesive element is supported by one film layer ring, and wherein each film layer ring can be separated from the remaining film layer rings. This arrangement provides a separate film layer ring for each ring of the adhesive element, where - suitably - separation of a film layer ring from the remaining film layer rings also separates the corresponding ring of the adhesive element from the remaining rings of the adhesive element. To facilitate removal of the film layer rings, each film layer ring suitably comprises a grip tab. Also, to aid separation of film layer rings, adjacent film layer rings may be defined by pre-cuts or embossments in the film layer. In a further aspect, the adhesive composition, and preferably the entire adhesive element, is plastically deformable. As an alternative, the adhesive composition, and preferably the entire adhesive element, is elastically deformable.

[0062] In one particular aspect, the outer edge of the adhesive element is defined by a non- deformable plastic ring, preferably made of polypropylene or polyethylene. This means that the adhesive element retains its outer dimensions, such that it can fit in a baseplate of a predetermined size.

[0063] According to one aspect of the adhesive element, each ring of the adhesive element is delimited by an inner ring edge and an outer ring edge, wherein the inner ring edge of each ring defines a through-going passage in said ring. Each ring suitably comprises the first composition and the second composition, and at least the second composition extends to the inner ring edge of each ring, about at least a portion of the circumference of the through- going passage. This arrangement allows similar functionality of each ring.

[0064] The first composition may also extend to the outer ring edge of each ring, about the circumference thereof, and wherein, optionally, the first composition also extends to the inner edge of each ring, about at least a portion of the circumference of the through-going passage.

[0065] Each ring may be in the form of a laminate in which the first composition and the second composition are arranged in individual layers. Each ring suitably comprises inner and outer sub-rings, wherein each inner sub-ring comprises or consists of the second composition and each outer sub-ring comprises or consists of the first composition. To aid separation of rings within the adhesive element, adjacent rings may be connected by frangible portions.

[0066] The adhesive element may comprise a spiral arrangement of ring elements. Accordingly, the ring segments may be connected by frangible portions and thereby form a spiral arrangement within the adhesive element. The spiral could be defined by a tear-line (kiss cut). The user can remove enough of the adhesive element to create just enough opening for the stoma by tearing along the spiral tear-line and then cutting with a pair of scissors. This embodiment provides a through-going passage in the adhesive element, the size of which can be finely adapted according to a user's needs, rather than according to standard dimensions provided by a manufacturer.

[0067] In one aspect, an inner edge of said first ring or ring segment comprises a plurality of slits or weakened regions extending from the circumference of the through-going passage towards the outer edge of the adhesive element. Suitably, an inner edge of each ring or ring segment comprises a plurality of slits or weakened regions extending from the circumference of the through-going passage towards the outer edge of the adhesive element. These embodiments allow the inner edge of the first ring or ring segment, and / or of each ring or ring segment to flex and more readily adopt to the shape of the stoma.

[0068] A release liner is suitably arranged on an adhesive surface of the adhesive element, so that it is protected prior to use.

[0069] The present disclosure also provides a base plate for an ostomy device, said baseplate comprising the adhesive element as defined herein. Also provided is an ostomy appliance, comprising the adhesive element as defined herein.

[0070] Embodiments, and features of the various exemplary embodiments described in this application, may be combined with each other ("mixed and matched"), unless specifically noted otherwise.

[0071] Detailed Description of the Drawing

[0072] In the following detailed description, reference is made to the accompanying drawings. The drawings form a part of this specification and illustrate exemplary embodiments for practicing the invention. Directional terminology, such as "top," "bottom," "front," "back," etc., is used with reference to the orientation of the figures being described. Because components of embodiments can be positioned in a number of orientations, the directional terminology is used for purposes of illustration and is in no way limiting. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the invention. The detailed description describes examples for practicing the invention and is not to be read to limit the scope of the invention. The scope of the invention is defined by the attached claims.

[0073] Fig. 1 shows an adhesive element 1. The adhesive element 1 consists of a plurality of rings 100 arranged concentrically around the through-going passage A, which is defined by the inner edge 12 of the adhesive element. Alternating rings 100 consist of the first adhesive composition 110, and the second water-swellable composition 120, with the innermost ring (that which extends to the inner edge of the adhesive element) consisting of the second water-swellable composition 120.

[0074] Fig. 2 shows a similar adhesive element 1. A plurality of rings is arranged concentrically around the through-going passage A. As shown, each ring comprises inner and outer subrings. Each inner sub-ring comprises the second composition 120 and each outer sub-ring comprises the first composition 110. The adhesive element comprises a film layer 140, which - in this figure - is constituted by a plurality of film layer rings, arranged concentrically around the through-going passage. Each ring of the adhesive element is supported by one film layer ring, such that each film layer ring can be separated from the remaining film layer rings. Removing one film layer ring, as shown, simultaneously removes one ring from the adhesive element.

[0075] In the adhesive element 1 shown in Figure 3, an innermost ring (that which extends to the inner edge of the adhesive element) consists of the second water-swellable composition 120. An outer ring consists of the first adhesive composition 110. The adhesive element 1 comprises a third adhesive layer 130 arranged adjacent the innermost ring of second water- swellable composition.

[0076] Figure 4 is a cross-sectional image of the adhesive element according to Figure 2, when in place around a stoma S. Reference numerals are as for Figure 2.

[0077] Figure 5 is a cross-sectional image of an adhesive element, when in place around a stoma.

[0078] Figure 6 is a cross-sectional image of an adhesive element, when in place around a stoma. In this adhesive element, the adhesive element comprises a first layer and a second layer, wherein said first adhesive layer consists of said first adhesive composition and the second layer consists of said second water-swellable composition. Each layer is constituted by a plurality of removable rings.

[0079] Figure 7 is a plan view of an adhesive element, in which the adhesive element is constituted by a plurality of ring segments. By the term "ring segments" is meant a portion of the adhesive element which does not extend around the entire circumference of the adhesive element. As such, the ring segments making up the adhesive element of Figure 7 form a spiral, defined by a separation or tear line. A user can remove enough of the adhesive element to create just enough opening for the stoma by tearing along the tear line and cutting with a pair of scissors.

[0080] Figure 8A and 8B show a further embodiment of an adhesive element 1. Figure 8A shows the adhesive element with all rings 100 in place; Figure 8B shows the adhesive element in which the first (inner) ring is removed. In this embodiment, the inner edge of said first ring or ring segment comprises a plurality of slits or weakened regions 111 extending from the circumference of the through-going passage towards the outer edge of the adhesive element. The slits or weakened regions define "fingers" or "brushes". Concentric rings can be removed by pulling the pull-tab. This embodiment allows flexibility in the adhesive element, that easily keeps portions of the adhesive element close to the skin and thus provides better fits to different stoma size and shapes.

[0081] EXAMPLES

[0082] Swelling speed test method

[0083] Swelling speed was tested by hot pressing the composition to be tested at 90 °C for 30 sec to a thickness of 1 mm between sheets of release liner (siliconized paper). From this, a ring (outer diameter 57 mm, hole diameter 27 mm) was cut. A hard plastic (polyoxymethylene, "POM") disc (diameter 17 mm, 3 mm thick) was attached with double sided adhesive tape in the center of a glass petri dish. The ring of swellable composition was mounted in the glass petri dish centred around the POM disc to give a 5 mm gap between the POM and the ring of swellable composition. When isotonic saline is added to sample to initiate swelling, the process is an inherently low contrast event. To increase contrast, crossed polarizing filters were used: A sheet of polarizing film was attached to a light table. The sample was placed on top of this film. A camera (Canon EOS 12000) was mounted to observe sample from above. On the lens of the camera was mounted another polarizing filter. This filter was then adjusted to let the least amount of light through (this happens when the 2 filters are at 90° orientation to each other). First picture of sample was taken, saline was added to cover the ring and subsequent pictures were taken at pre-determined time points, such as 1-24 hours. The gap between the ring and the POM disc at positions 12-3-6-9 o'clock was now measured using Image], both at start (tO) and at later time points. The average change in gap size was calculated and reported in mm at the different time points.

[0084] FORMULATION 1

[0085] A water-swellable composition (slow)- approximately 3 mm / h

[0086] FORMULATION 2 A water-swellable composition (fast) app. 10-20 mm / h

[0087] FORMULATION 3

[0088] Another example of a fast water-swellable composition is: All compositions can be produced in a lab speedmixer in 100 g scale, after mixing at ambient temperature for 5 min at a speed of 3500 rpm.

Claims

CLAIMS1. An adhesive element (1) for an ostomy device, said adhesive element comprising : a first adhesive composition (110), and a second, water-swellable composition (120), wherein the adhesive element is delimited by an outer edge and has a center portion, wherein at least the second composition extends to the center portion of the adhesive element, wherein said adhesive element has at least one adhesive surface, characterised in that the adhesive element is constituted by a plurality of rings or ring segments (100), arranged concentrically around the center of the adhesive element towards the outer edge of the adhesive element, whereby at least a first ring or ring segment, being located at the center portion of the adhesive element, can be separated from the remaining rings or ring segments of the adhesive element.

2. The adhesive element (1) according to claim 1 wherein the second, water-swellable composition is non-adhesive.

3. The adhesive element (1) according to any one of the preceding claims wherein the adhesive element is ring-shaped and delimited by an inner edge and an outer edge, wherein the inner edge (12) of the adhesive element defines a through-going passage in said adhesive element, wherein the adhesive element is constituted by a plurality of rings or ring segments (100), arranged concentrically around the through-going passage from the inner edge of the adhesive element towards the outer edge of the adhesive element.

4. The adhesive element (1) according to any one of the preceding claims wherein the second composition (120) comprises a clay, such as a smectite clay, preferably bentonite orlaponite, more preferably laponite; or wherein the second composition comprises superabsorbent fibres, and is preferably a non-woven mat of superabsorbent fibres.

5. The adhesive element (1) according to any one of the preceding claims, wherein the second composition is a gel-forming composition.

6. The adhesive element (100) according to any one of the preceding claims, wherein the second composition (120) disintegrates upon exposure to moisture.

7. The adhesive element (1) according to any one of claims 3-6, wherein the inner edge of the adhesive element, about the circumference of the through-going passage, is constituted by the second composition.

8. The adhesive element (1) according to any one of claims 3-7, wherein the first composition extends to the inner edge of the adhesive element, about the circumference of the through-going passage.

9. The adhesive element (1) according to any one of the preceding claims, wherein - when the adhesive element is exposed to moisture - the second composition (120) has a swelling rate, when measured as according to the swelling speed test method described in the specification, which is higher than said first composition (110).

10. The adhesive element (1) according to any one of the preceding claims, wherein the adhesive element comprises a first layer and a second layer, wherein said first layer consists of said first adhesive composition and the second layer consists of said second, water- swellable composition, wherein said first layer comprises a first primary face and said second layer comprises a second primary face, preferably wherein the first and second layers are arranged such that the first primary face of the first layer and the second primary face of the second layer are arranged in contact with each other in said adhesive element.

11. The adhesive element (1) according to claim 10, wherein said adhesive element (100) further comprises a third adhesive layer (130), preferably wherein the second layer (120) is arranged between the third layer (130) and the first layer (110).

12. The adhesive element (1) according to claim 11, wherein the adhesive composition of the first layer is an elastic adhesive and wherein the adhesive composition of the third layer is a plastic adhesive.

13. The adhesive element (100) according to any one of claims 1-12, wherein the adhesive element comprises a first layer and a second layer, wherein said first adhesive layer consists of said first adhesive composition and the second layer consists of said second water-swellable composition, wherein said first and second layer are arranged adjacent one other in the plane of the adhesive element, preferably wherein the inner edge of the adhesive element, about the circumference of the through-going passage, is constituted by the second composition.

14. The adhesive element (1) according to any one of the preceding claims, wherein said adhesive element (100) further comprises at least one film layer (140), suitably wherein at least one film layer is arranged on an external surface of the adhesive element.

15. The adhesive element (1) according to any one of the preceding claims, wherein the adhesive element comprises a first layer and a second layer, wherein said first adhesive layer consists of said first adhesive composition and the second layer consists of said second water-swellable composition, wherein at least one film layer is arranged between said first and second layers.

16. The adhesive element (1) according to any one of claims 14-15, wherein said film layer is plastically deformable.

17. The adhesive element (1) according to any one of claims 14-16, wherein said film layer is elastically deformable.

18. The adhesive element (1) according to any one of claims 14-17, wherein the film layer is constituted by a plurality of film layer rings, arranged concentrically around the through- going passage from the inner edge of the adhesive element towards the outer edge of the adhesive element, wherein each ring of the adhesive element is supported by one film layer ring, and wherein each film layer ring can be separated from the remaining film layer rings.

19. The adhesive element (1) according to claim 18, where each film layer ring comprises a grip tab.

20. The adhesive element (1) according to any one of claims 18-19, where adjacent film layer rings are defined by pre-cuts or embossments in the film layer.

21. The adhesive element (1) according to any one of the preceding claims, wherein said adhesive composition, and preferably the entire adhesive element, is plastically deformable.

22. The adhesive element (1) according to any one of the claims 1-21, wherein said adhesive composition, and preferably the entire adhesive element, is elastically deformable.

23. The adhesive element (1) according to any one of the preceding claims, wherein the outer edge of said adhesive element is defined by a non-deformable plastic ring, preferably made of polypropylene or polyethylene.

24. The adhesive element (1) according to any one of the preceding claims, wherein each ring of the adhesive element is delimited by an inner ring edge and an outer ring edge, wherein the inner ring edge of each ring defines a through-going passage in said ring, wherein each ring comprises said first composition and said second composition, and wherein at least the second composition extends to the inner ring edge of each ring, about at least a portion of the circumference of the through-going passage.

25. The adhesive element (1) according to claim 24, wherein the first composition extends to the outer ring edge of each ring, about the circumference thereof, and wherein, optionally, the first composition also extends to the inner edge of each ring, about at least a portion of the circumference of the through-going passage.

26. The adhesive element (1) according to any one of claims 24-25, wherein each ring is in the form of a laminate in which the first composition and the second composition are arranged in individual layers.

27. The adhesive element (1) according to any one of claims 24-26, wherein each ring comprises inner and outer sub-rings, wherein each inner sub-ring comprises the second composition and each outer sub-ring comprises of the first composition.

28. The adhesive element (1) according to any one of the preceding claims, wherein adjacent rings are connected by frangible portions.

29. The adhesive element (1) according to any one of claims 1-23, wherein the ring segments are connected by frangible portions and thereby form a spiral arrangement within the adhesive element.

30. The adhesive element (1) according to any one of the preceding claims, wherein a release liner (107) is arranged on the adhesive external surface of the adhesive element.

31. The adhesive element (1) according to any one of the preceding claims, having a laminate construction with the following arrangement of layers, in order: an adhesive layer, a layer of said second water-swellable composition, a film layer, a superabsorbent fiber layer a topfilm layer.

32. The adhesive element (1) according to any one of claims 3-31, wherein an inner edge of said first ring or ring segment comprises a plurality of slits or weakened regions (111) extending from the circumference of the through-going passage towards the outer edge of the adhesive element.

33. The adhesive element (1) according to any one of claims 3-32, wherein an inner edge of each ring or ring segment comprises a plurality of slits or weakened regions (111) extending from the circumference of the through-going passage towards the outer edge of the adhesive element.

34. A base plate (100) for an ostomy device, said baseplate (100) comprising the adhesive element (1) as defined in any one of the preceding claims.

35. An ostomy appliance, said ostomy appliance comprising the adhesive element (100) as defined in any one of claims 1-33.

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