Adhesive element for sealing around a stoma

Abstract

An adhesive element is provided for an ostomy device, said adhesive element comprising a first adhesive composition, and a second water-swellable composition. The adhesive element is ring-shaped and delimited by an inner edge and an outer edge. The adhesive element comprises at least one slit, extending through at least the second composition, said at least one slit extending from the inner edge of the adhesive element towards the outer edge of the adhesive element.

Description

[0001] ADHESIVE ELEMENT FOR SEALING AROUND A STOMA

[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 42, and an ostomy appliance according to claim 43.

[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 1A shows a cut-away illustration of an adhesive element according to the invention.

[0010] Figure IB shows the adhesive element according to Fig. 1A, flexed to show how the slits separate.

[0011] Figure 2 shows a cut-away illustration of an adhesive element according to the invention, in which the slits consist of a line of perforations.

[0012] Figure 3 is a cut-away illustration of an adhesive element, incorporated into a baseplate, which is incorporated into an ostomy appliance. Figure 4 shows a cut-away illustration of an alternative adhesive element according to the invention.

[0013] Figures 5A - 51 show cross-sectional views of various adhesive elements, having possible arrangements of first and second compositions

[0014] Figures 6-8 show a baseplate and details of a baseplate

[0015] Figures 9A-9C show various designs / arrangements of the slits / weakened zones, having different cutting geometries.

[0016] Figure 10A-C show various designs / arrangements of the slits / weakened zones having different cutting geometries, further comprising one or more secondary slits in the second composition which encircle the center portion of the adhesive element.

[0017] Figures 11A-C show various arrangements of elastically deformable structure(s) arranged on an external surface of the adhesive element.

[0018] Figure 12 shows a baseplate, in which the brushes are partly covered by a cover.

[0019] Figure 13 shows a baseplate incorporating "micro brushes"

[0020] Figures 14A (planar view) and 14B (cutaway view) show a further potential construction of a second water-swellable composition.

[0021] DETAILED DESCRIPTION

[0022] 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.

[0023] 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. 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.

[0024] In the following, the words "ostomy" and "stoma" are used interchangeably without any intention to have different meanings.

[0025] 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.

[0026] 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.

[0027] An adhesive element for an ostomy device is thus provided, said adhesive element comprising: a first adhesive composition, and a second water-swellable composition,

[0028] 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.

[0029] 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. 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.

[0030] The adhesive element is delimited by an outer edge and has a center. Suitably, the adhesive element is ring-shaped and delimited by an inner edge and an outer 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-going 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.

[0031] 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.

[0032] In aspects, the inner edge of the adhesive element defines a through-going hole in said adhesive element, for accommodating a stoma. The through-going hole in said adhesive element is centered about the center of said adhesive element. 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.

[0033] 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.

[0034] 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.

[0035] The adhesive element comprises at least one slit or weakened zone in the second composition. A slit is formed by cutting the second composition as required. A weakened zone is a zone, where a slit can be formed upon use, but which is closed prior to use. A weakened zone is for example a perforated zone, or a thinner zone, in the second composition.

[0036] The at least one slit or weakened zone extending from the center of the adhesive element towards the outer edge of the adhesive element. In aspects, the second composition is located at least at the center of the adhesive element.

[0037] Suitably, the adhesive element comprises at least one slit, extending through at least the second composition. In aspects, the at least one slit extends from the inner edge of the adhesive element towards the outer edge of the adhesive element.

[0038] The slits in the adhesive element - in particular in the second composition - promote flexibility of the adhesive element and allowing the adhesive element to be effectively expanded (particularly at the inner edge thereof) when placed over a stoma. This is particularly of interest if the second composition is non-plastic and has a tendency to resist tensional forces.

[0039] In one aspect, the at least one slit of the adhesive element extends through both the first composition and the second composition. In this manner, the first and second composition can both be flexible, as required.

[0040] Furthermore, the at least one slit may extend through the entire adhesive element.

[0041] The adhesive element suitably comprises at least 2 slits, such as e.g. at least 3 slits, at least 4 slits, at least 5 slits, at least 6 slits, at least 7 slits or at least 8 slits; preferably wherein adjacent slits are arranged equidistantly about the inner edge of the adhesive element. By increasing the number of slits, the desired flexibility of the adhesive element can be achieved.

[0042] In one aspect, the at least one slit, and preferably all slits, has / have a curved shape extending from the inner edge of the adhesive element. Furthermore, at least one slit suitably consists of a line of perforations in the adhesive element. The slits consisting of a line of perforations retain the form of the adhesive element prior to use, but can be broken under the forces applied during use.

[0043] First adhesive composition 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.

[0044] 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.

[0045] 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).

[0046] In embodiments, the adhesive composition comprises absorbent material selected from the group consisting of hydrocolloids, microcolloids, salt, and super absorbent particles.

[0047] 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.

[0048] Second water-swellable composition

[0049] The adhesive element comprises a second, preferably non-adhesive, 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 non-adhesive. By non-adhesive is meant that it cannot support its own weight when adhered to a vertical surface. Suitably, the second composition is a gelforming composition. Suitably, the second composition disintegrates upon exposure to moisture.

[0050] 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.

[0051] 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.

[0052] 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.

[0053] 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 XXnm, such that is provides a cushioning effect and presses the proximal surface of the adhesive wafer towards the skin.

[0054] Layered adhesive element

[0055] 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, wherein the 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. The second layer suitably has a thickness of between 0.1 and 3mm. The second layer suitably has an extension radially from the through-going hole of between 10 and 50mm.

[0056] The dimension of the first layer in a direction away from the stomal through-going 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.

[0057] 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.

[0058] The adhesive element may comprise 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.

[0059] 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.

[0060] 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.

[0061] The at least one film layer may be arranged such that it encircles the center portion of the adhesive element, preferably - in the case where the inner edge of the adhesive element defines a through-going hole in said adhesive element -the at least one film layer does not extend to the through-going hole.

[0062] 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. 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] A release liner is suitably arranged on an adhesive surface of the adhesive element, so that it is protected prior to use.

[0067] At least a portion of the inner edge of the adhesive element may be a rolled inner edge. This means that the inner edge is fixed in an outwardly-rolled form prior to use. Once put in place around a stoma, the inner edge can be unrolled, such that it meets the stoma.

[0068] The slits in the adhesive element may suitably define at least two flaps at the inner edge of the adhesive element, wherein said flaps partly overlap in a direction parallel to the axis of the through-going hole in said adhesive element. This provides an adhesive element with a "camera aperture" structure at the inner edge thereof, which can be more easily adjusted to fit around a stoma.

[0069] The adhesive element may comprise a plurality of slits or weakened zones in the second composition, such as e.g. 2-50 slits or weakened zones, or 5-20 slits or weakened zones, at least one of which extends from a center portion of the adhesive element towards the outer edge of the adhesive element. The more slits are present, the more flexible the adhesive element becomes. In one design, all slits or weakened zones radiate outwards from the center portion of the adhesive element towards the outer edge of the adhesive element. This design allows equal flexibility of the adhesive element in all directions.

[0070] In another design, a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition are aligned substantially parallel to said first slit or weakened zone in the plane of the adhesive element. This design provides a primary axis of flexibility, with a series of "brushes" in the adhesive element.

[0071] In another design, a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards, and preferably to, the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition extend from said first slit or weakened zone towards the outer edge of the adhesive element. This design provides a primary axis of flexibility, with a series of "brushes" in the adhesive element. Also, potential sharp edges created towards the center of the adhesive element are reduced or avoided.

[0072] In another design, the adhesive element comprises one or more secondary slits or weakened zones in the second composition, which intersect at least two of the slits or weakened zones which extend from the center portion of the adhesive element towards the outer edge of the adhesive element. These one or more secondary slits or weakened zones in the second composition may encircle the center portion of the adhesive element, preferably in a concentric manner. The secondary slits or weaknesses can be used to improve the flexibility of each "brush" or "finger".

[0073] To keep the adhesive element in as close contact to the skin as possible, over a greater areas as possible, the adhesive element may further comprises at least one elastically deformable structure arranged on an external surface of the adhesive element, said elastic structure being discontinuous in the plane of the adhesive element and being arranged to resist displacement of least a portion of the second composition from the plane of the adhesive element. The at least one elastically deformable structure may take the form of elastic segments, elastic strings or elastic rings arranged on a surface of the second composition.

[0074] Suitably, the at least one slit or weakened zone, and preferably all slits or weakened zones, extend(s) from a center portion of the adhesive element to the outer edge of the adhesive element, or wherein the at least one slit or weakened zone, and preferably all slits or weakened zones, extend(s) from a center portion of the adhesive element towards, but do not extend to the outer edge of the adhesive element.

[0075] 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.

[0076] 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.

[0077] Detailed Description of the Drawing

[0078] 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.

[0079] Figure 1A shows a cut-away illustration of an adhesive element 100. The adhesive element comprises a first adhesive composition (110), and a second water-swellable composition (120). The adhesive element 100 is essentially circular and is delimited by an outer edge, and has a center. The adhesive element comprises slits (130), in the second composition, extending from center of the adhesive element towards the outer edge of the adhesive element.

[0080] Figure IB shows the adhesive element 100 according to Fig. 1A, flexed to show how the slits separate. As the center of the adhesive element is pushed upwards, the slits allow the element to separate, creating an adaptable through-going hole.

[0081] Figure 2 shows a cut-away illustration of an adhesive element according to the invention, in which the slits consist of a line of perforations. In this layout, the first adhesive composition 110 and the second composition 120 are arranged as concentric rings in the adhesive element. This adhesive element 100 comprises a central through-going hole. The second composition extends to the inner edge of the adhesive element, about the circumference of the through-going passage.

[0082] Figure 3 is a cut-away illustration of an adhesive element (100), incorporated into a baseplate (10), which is incorporated into an ostomy appliance (50).

[0083] Figure 4 shows a cut-away illustration of an alternative adhesive element according to the invention. In this adhesive element, the slits in the adhesive element define at least two flaps at the inner edge of the adhesive element, and wherein said flaps partly overlap in a direction parallel to the axis of the through-going hole in said adhesive element.

[0084] Figures 5A - 51 show cross-sectional views of various adhesive elements, having possible arrangements of first 110 and second 120 compositions. In each of Figures 5A-5I, the upper figure shows the adhesive element in the form in which it is applied to the user's skin, around a stoma S. The lower figure shows the adhesive element after being swelled; i.e. after contact with liquid.

[0085] The lighter shaded component in each of Figures 5A-5I is the adhesive composition 110. The darker shaded component is the water-swellable composition 120. Each figure illustrates how the water-swellable composition swells upon contact with liquid, and expands about the stoma S.

[0086] In Figure 5A the adhesive composition forms a ring about the stoma. The water-swellable composition 120 is in the form of a thinner, smaller ring, embedded in a region of the adhesive composition 110 lying closest to the user's skin and adjacent the through-going hole. The water-swellable composition 120 swells upon contact with liquid, and expands about the stoma S.

[0087] Figure 5B shows an adhesive element similar to that of Figure 5A, in which the water- swellable composition 120 protrudes further into the through-going hole than the adhesive composition 110, and can therefore make good contact with liquid, before the adhesive composition does.

[0088] Figure 5C shows an adhesive element similar to that of Figure 5A, in which the water- swellable composition 120 lies furthest from the skin.

[0089] Figure 5D shows an adhesive element similar to that of Figure 5C, in which the water- swellable composition 120 protrudes further into the through-going hole than the adhesive composition 110. In Figure 5E, the water-swellable composition 120 is in the form of an inner ring, and constitutes the inner edge of the adhesive element, about the through-going hole.

[0090] Figure 5F has a similar arrangement of compositions 110, 120 to that of Figure 5E, and where the water-swellable composition 120 also extends partly under the adhesive composition, at the skin surface.

[0091] Figure 5G is a similar arrangement to Figure 5F, in which the water-swellable composition 120 also extends partly over the adhesive composition, opposite the skin surface.

[0092] In Figure 5Ha the water-swellable composition 120 is sandwiched between two portions of the adhesive composition. The outer surfaces of this adhesive element are therefore constituted fully by adhesive composition 120. The water-swellable composition 120 protrudes further into the through-going hole than the adhesive composition 110.

[0093] Figure 5Hb shows an adhesive element similar to that of Figure 5Ha, in which the water- swellable composition 120 does not protrude further into the through-going hole than the adhesive composition 110.

[0094] Figure 51 shows an adhesive element in which the adhesive composition 110 and the water- swellable composition 120 are arranged as concentric rings about the through-going hole.

[0095] Figure 6 shows a perspective view of a design for an adhesive element, being comprised within an ostomy baseplate. The second water-swellable composition 120 is arranged about the center portion of the adhesive element, in the plane of the baseplate, while the first adhesive composition 110 is arranged about the second composition, in a radial direction of the baseplate. The adhesive element comprises slits 130 in the second composition, about the center portion. A parafilm layer is located on top of the second water-swellable composition.

[0096] Figure 7 is a detail of the baseplate shown in Figure 6 showing the second water-swellable composition 120 with the first adhesive composition 110 arranged about the center portion of the adhesive element, in the plane of the baseplate. A cover 160 comprises the uppermost layer about the center portion. This cover 160 could be connected to the second water- swellable composition 120 or it could disintegrate (i.e. not welded / glued) in order to move freely. Figure 7 also illustrates film layer 180 used to support the second water-swellable composition 120. The purpose of the cover 160 is to prevent output from reaching the skin through the slits, to prevent the swelled second water-swellable composition from being washed away, to prevent the fingers / brushes from being deformed during cleaning and to hold the brushes in place and towards the skin. The cover could be colored so that the used second water-swellable composition and dirty gel are not visible during bag change.

[0097] As also shown in Figure 7, the cover extends towards the center portion to a greater extent than the second water-swellable composition. This construction holds and protects the second water-swellable composition. It can also gently scrape off mycosis from the stoma so that the second water-swellable composition can swell / dissolve faster.

[0098] Figure 8 shows a detail of a baseplate similar to that shown in Figure 6, but without the cover layer. The second water-swellable composition (120 lowermost layer) is connected / welded to the film layer 180. The film layer 180 could be on the upper side of the second water- swellable composition (as shown), inside the second water-swellable composition (i.e. having second water-swellable composition on both faces) or on the skin side of the second water- swellable composition. A film layer 180 could also be placed on each side of the second water-swellable composition in a sandwich-type configuration.

[0099] Figures 9A-9C show various designs / arrangements of the slits / weakened zones 130, with different cutting geometries.

[0100] Figure 9A shows (as per figure 8) that slits 130 radiate outwards from the center portion of the adhesive element towards the outer edge of the adhesive element.

[0101] Figure 9B shows that slits 130 may be arranged in a parallel manner (so-called "brushes"), i.e. wherein a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition are aligned substantially parallel to said first slit or weakened zone in the plane of the adhesive element

[0102] Figure 9C shows that slits 130 may be arranged so as to be angled, i.e. a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards, and preferably to, the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition extend from said first slit or weakened zone towards the outer edge of the adhesive element. Figure 10A-C show various designs / arrangements of the slits / weakened zones 130, with different cutting geometries, further comprising one or more secondary slits in the second composition which encircle the center portion of the adhesive element.

[0103] The secondary slits may be positioned underneath the carrier film and may be needed in case the second composition is stiff and not easily bendable. The secondary slits may control the bending extent and / or direction.

[0104] Figure 10A shows parallel slits, as per Figure 9B, including secondary slits which encircle the center portion of the adhesive element.

[0105] Figure 10B shows a perspective view of the design of Figure IDA. In this example, the carrier film is in the center and the lower part of the second water-swellable composition 120 is cut to cater for upwards bending of the arms.

[0106] Figure 10C shows angled slits, as per Figure 9C, additionally comprising secondary slits 160 arranged in a "spiderweb" pattern, between each of the angled slits.

[0107] Figures 11A-C show elastically deformable structure(s) 160 arranged on an external surface of the adhesive element. The elastic structure(s) is / are discontinuous in the plane of the adhesive element (100) and arranged to resist displacement of least a portion of the second composition from the plane of the adhesive element.

[0108] In other words, the deformable structure(s) 160 hold down the adhesive element - in particular the second water-swellable composition - towards the skin. This - in turn - minimizes the opportunity for output under the second water-swellable composition. The deformable structure(s) could be elastic or stretchy (e.g. Parafilm or Vita-Wrap). At least the central part of the deformable structure 160 is not connected to the second water-swellable composition - it is allowed to move freely when being pushed upwards / outwards by the second water-swellable composition.

[0109] Figure 11A shows deformable structure(s) 160 in the form of concentric rings about the center portion of the adhesive element. This design allows segments of the deformable structure to be removed. For instance, the inner segments of the deformable structure 160 are removed until the hole size fits the stoma. The deformable structure be peel-welded, glued or comprise a perforated sheet where rings can be removed.

[0110] Figure 11B shows the deformable structure(s) 160 in the form of two elastic strings extending about the center portion of the adhesive element from opposite edges thereof. Figure 11C shows deformable structure(s) 160 in the form of concentric rings, as per Figure 11A, in which adjacent concentric rings are connected.

[0111] Figure 12 shows a baseplate similar to that of Figure 9B, in which the brushes are partly covered by a cover 160. This cover 160 extends towards the center portion to a lesser extent than the second water-swellable composition. It therefore allows the brushes to be deflected by the stoma, and the (now) deformed / angled brushes press the edge of the cover 160outwards so that it opens up radially and not only stretches upwards.

[0112] Figure 13 shows a baseplate similar to that of Figure 12. This design incorporates "micro brushes" with a larger surface area on the inner diameter to speed up the swelling rate from the start. In this design, a larger number of shorter, wider slits 130 are present in the second water-swellable composition. It could also be possible to combine this design with one of the other designs, such that microbrushes as per Figure 13 are be applied to the end of the brushes as per e.g. Figure 9A, 9B or 9C.

[0113] Further, the inner edge of the adhesive element of Figure 13 will be softer, as it is not rigid. It would thereby be gentler to the stoma in those situations where the plate is misplaced and overlaps with the stoma. It will also be possible to apply the baseplate of Figure 13 on a "mushroom stoma" where the baseplate needs to be applied over a larger diameter (swollen stoma) than the sealing diameter at skin level.

[0114] Figures 14A (planar view) and 14B (cutaway view) show a further potential construction of a second water-swellable composition 120. The second water-swellable composition 120 is disc-shaped and comprises deep through-going slits 130 extending from the through-going hole towards the outer edge. Each "finger" thus created also comprises secondary slits 150 which encircle the center portion of the adhesive element. Not only do these secondary slits 150 provide flexibility to the "fingers", the fingers can easily be cut or peeled to cover different sized or shaped stomas. The segments can be either broken off or clipped off with a pair of scissors or even a nail cutter.

[0115] EXAMPLES

[0116] Swelling speed test method

[0117] 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. FORMULATION 1

[0118] A water-swellable composition (slow)- approximately 3 mm / h

[0119] FORMULATION 2

[0120] A water-swellable composition (fast) app. 10-20 mm / h Poly ethylene glycol 5-20

[0121] FORMULATION 3

[0122] 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 (100) 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, wherein said adhesive element has at least one adhesive surface, characterised in that, the adhesive element comprises at least one slit or weakened zone (130), in the second composition, said at least one slit or weakened zone extending from a center portion of the adhesive element towards the outer edge 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 (100) according to any one of the preceding claims wherein the second composition is located at least at the center of the adhesive element.

4. The adhesive element (100) according to any one of the preceding claims, wherein the adhesive element comprises at least one slit (130), extending through at least the second composition.

5. The adhesive element (100) 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 of the adhesive element defines a through-going hole in said adhesive element, for accommodating a stoma, wherein the through-going hole in said adhesive element is centered about the center of said adhesive element.

6. The adhesive element (100) according to claim 5, wherein at least the second composition extends to the inner edge of the adhesive element, about at least a portion ofthe circumference of the through-going passage, and wherein the adhesive element comprises at least one slit (130), extending through at least the second composition, said at least one slit extending from the inner edge of the adhesive element towards the outer edge of the adhesive element.

7. The adhesive element (100) according to any one of claims 5-6, 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 (100) according to any one of claims 5-7, 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 (100) according to any one of the preceding claims wherein the second composition (120) comprises a clay, such as a smectite clay, preferably bentonite or laponite, more preferably laponite; or wherein the second composition comprises superabsorbent fibres, and is preferably a non-woven mat of superabsorbent fibres.

10. The adhesive element (100) according to any one of the preceding claims, wherein the second composition is a gel-forming composition.

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

12. The adhesive element (100) according to any one of the preceding claims, wherein the at least one slit of the adhesive element extends through both the first composition and the second composition.

13. The adhesive element (100) according to any one of the preceding claims, wherein the at least one slit extends through the entire adhesive element.

14. The adhesive element (100) according to any one of the preceding claims, wherein the adhesive element comprises at least 2 slits, such as e.g. at least 3 slits, at least 4 slits, at least 5 slits, at least 6 slits, at least 7 slits or at least 8 slits; preferably wherein adjacent slits are arranged equidistantly about the inner edge of the adhesive element.

15. The adhesive element (100) according to any one of the preceding claims, wherein the at least one slit or weakened zone, and preferably all slits or weakened zones, has / have a curved shape.

16. The adhesive element (100) according to any one of the preceding claims, wherein at least one weakened zone consists of a line of perforations in the adhesive element.

17. The adhesive element (100) 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).

18. The adhesive element (100) 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, preferably 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.

19. The adhesive element (100) according to claim 18, wherein said adhesive element (100) further comprises a third adhesive layer (190), wherein the second layer (120) is arranged between the third layer (190) and the first layer (110).

20. The adhesive element (100) according to claim 19, 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.

21. The adhesive element (100) according to any one of claims 1-20, 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.

22. The adhesive element (100) according to any one of the preceding claims, wherein said adhesive element (100) further comprises at least one film layer (180), suitably wherein at least one film layer is arranged on an external surface of the adhesive element.

23. The adhesive element (100) according to any one of the preceding claims, wherein said at least one film layer is arranged such that it encircles the center portion of the adhesive element, preferably - in the case where the inner edge of the adhesive element defines a through-going hole in said adhesive element -the at least one film layer does not extend to the through-going hole.

24. The adhesive element (100) 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.

25. The adhesive element (100) according to claim 24, wherein said film layer is plastically deformable.

26. The adhesive element (100) according to claim 24, wherein said film layer is elastically deformable.

27. The adhesive element (100) according to any one of claims 1-25, wherein said adhesive composition, and preferably the entire adhesive element, is plastically deformable.

28. The adhesive element (100) according to any one of claims 1-24 and 26, wherein said adhesive composition, and preferably the entire adhesive element, is elastically deformable.

29. The adhesive element (100) 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.

30. The adhesive element (100) according to any one of the preceding claims, wherein a release liner (107) is arranged on an adhesive surface of the adhesive element.

31. The adhesive element (100) according to any one of claims 5-30, wherein at least a portion of the inner edge of the adhesive element is a rolled inner edge.

32. The adhesive element (100) according to any one of claims 5-31, wherein the slits in the adhesive element define at least two flaps at the inner edge of the adhesive element, and wherein said flaps partly overlap in a direction parallel to the axis of the through-going hole in said adhesive element.

33. The adhesive element (100) according to any one of the preceding claims, comprising a plurality of slits or weakened zones in the second composition, such as e.g. 2-50 slits or weakened zones, or 5-20 slits or weakened zones, at least one of which extends from a center portion of the adhesive element towards the outer edge of the adhesive element.

34. The adhesive element (100) according to claim 33, wherein all slits or weakened zones radiate outwards from the center portion of the adhesive element towards the outer edge of the adhesive element.

35. The adhesive element (100) according to claim 33, wherein a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition are aligned substantially parallel to said first slit or weakened zone in the plane of the adhesive element.

36. The adhesive element (100) according to claim 33, wherein a first slit or weakened zone extends in a straight line from a center portion of the adhesive element towards, and preferably to, the outer edge of the adhesive element, wherein the remaining slits or weakened zones in the second composition extend from said first slit or weakened zone towards the outer edge of the adhesive element.

37. The adhesive element (100) according to any one of claims 33-36, further comprising one or more secondary slits or weakened zones (150) in the second composition, which intersect at least two of the slits or weakened zones which extend from the center portion of the adhesive element towards the outer edge of the adhesive element.

38. The adhesive element (100) according to claim 37, comprising one or more secondary slits or weakened zones (150) in the second composition, which encircle the center portion of the adhesive element, preferably in a concentric manner.

39. The adhesive element (100) according to any one of the preceding claims, wherein said adhesive element (100) further comprises at least one elastically deformable structure (160) arranged on an external surface of the adhesive element, said elastic structure (160) being discontinuous in the plane of the adhesive element (100) and being arranged to resistdisplacement of least a portion of the second composition from the plane of the adhesive element.

40. The adhesive element (100) according to claim 39, wherein said at least one elastically deformable structure (160) is in the form of elastic segments, elastic strings or elastic rings arranged on a surface of the second composition.

41. The adhesive element (100) according to any one of the preceding claims, wherein the at least one slit or weakened zone (130), and preferably all slits or weakened zones, extend(s) from a center portion of the adhesive element to the outer edge of the adhesive element, or wherein the at least one slit or weakened zone, and preferably all slits or weakened zones, extend(s) from a center portion of the adhesive element towards, but do not extend to the outer edge of the adhesive element.

42. A base plate (10) for an ostomy device, said baseplate (10) comprising the adhesive element (100) as defined in any one of the preceding claims.

43. An ostomy appliance (50), said ostomy appliance comprising the adhesive element (100) as defined in any one of claims 1-41.

Images